Investigation into Mid Staffordshire NHS Foundation Trust · Investigation into Mid Staffordshire...

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Inspecting Informing Improving Investigation into Mid Staffordshire NHS Foundation Trust March 2009 Investigation

Transcript of Investigation into Mid Staffordshire NHS Foundation Trust · Investigation into Mid Staffordshire...

Page 1: Investigation into Mid Staffordshire NHS Foundation Trust · Investigation into Mid Staffordshire NHS Foundation Trust 1 Contents The Healthcare Commission 2 Summary 3 Introduction

Inspecting Informing Improving

Investigation into Mid Staffordshire NHSFoundation TrustMarch 2009

Investigation

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© March 2009 Commission for Healthcare Audit and Inspection.

This document may be reproduced in whole or in part in anyformat or medium for non-commercial purposes, provided that itis reproduced accurately and not used in a derogatory manner orin a misleading context. The source should be acknowledged, byshowing the document title and © Commission for HealthcareAudit and Inspection 2009.

Concordat gateway number: 167

ISBN: 978-1-84562-220-6

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1Investigation into Mid Staffordshire NHS Foundation Trust

Contents

The Healthcare Commission 2Summary 3Introduction 14The trust’s history and role 16Emergency admissions 18Outcomes for patients and mortality rates 20The trust’s arrangements for the collection, reporting, analysis and use of clinical data 26Quality of care at the trust 29Emergency care pathway 38

Accident and emergency department 38Emergency assessment unit 53Medical admissions and the care of people admitted as medical emergencies 61Patients admitted as emergencies with surgical problems or traumatic injuries 71

Healthcare-associated infections and the control of infection 84Factors at a strategic level to reduce risk and protect the safety of patients 90Developments at the trust since the start of the investigation 112The role of other agencies 118Conclusions 123Recommendations 137

Appendix A: The Healthcare Commission's criteria for an NHS investigation 139Appendix B: The investigation team 140Appendix C: Interviews 141Appendix D: Sources of information 143Appendix E: Statistical appendix 145Appendix F: Letter from the Healthcare Commission to the trust concerning A&E, 23 May 2008 160Appendix G: Letter from the Healthcare Commission to the trust about concerns raised by patients and relatives, 7 July 2008 163Appendix H: Letter from the Healthcare Commission to the trustfollowing the conclusion of formal interviews, 15 October 2008 165Appendix I: Developments in nursing at the trust from early 2007 to early 2009, as supplied by the trust 168

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The Healthcare Commission

The Healthcare Commission’s full name is theCommission for Healthcare Audit andInspection. We exist to promote improvementsin the quality of healthcare and public healthin England. We are committed to making areal difference to the provision of healthcareand to promoting continuous improvement forthe benefit of patients and the public.

The Healthcare Commission was createdunder the Health and Social Care (CommunityHealth and Standards) Act 2003. We have astatutory duty to assess the performance ofhealthcare organisations, award annualratings of performance for the NHS andcoordinate reviews of healthcare with others.

We have created an entirely new approach toassessing and reporting on the performanceof healthcare organisations. Our annualhealth check examines a much broader rangeof issues than in the past, enabling us toreport on what really matters to those whoreceive and provide healthcare.

On 1 April 2009, the Care Quality Commission,the new independent regulator of health,mental health and adult social care, will takeover the Healthcare Commission’s work inEngland.

Investigating serious failings inhealthcare The Healthcare Commission is empowered bysection 52(1) of the Health and Social Care(Community Health and Standards) Act 2003 toconduct investigations into the provision ofhealthcare by or for an English NHS body.

We will usually investigate when allegations ofserious failings are raised, particularly whenthere are concerns about the safety ofpatients. Our criteria for deciding whether toconduct an investigation are set out inappendix A.

In investigating allegations of serious failingsin healthcare, we aim to help organisations toimprove the quality of care they provide, tobuild or restore public confidence inhealthcare services, and to seek to ensurethat the care provided to patients is safethroughout the NHS.

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The Healthcare Commission carried out thisinvestigation into apparently high mortalityrates in patients admitted as emergencies toMid Staffordshire NHS Foundation Trust sinceApril 2005, and the care provided to thesepatients. It also considered the trust’sarrangements for monitoring mortality ratesand its systems for ensuring that patientswere cared for safely.

Our particular focus was on emergencyadmissions. We looked at the pathway of carefor patients admitted as emergencies: theaccident and emergency (A&E) department,the emergency assessment unit, and thesurgical and medical elements of emergencyadmissions.

The investigation was carried out betweenMarch 2008 and October 2008. Staff from theHealthcare Commission worked with a team ofexternal expert advisers. The membership islisted in appendix B. We interviewed over 300people, including almost 100 patients admittedas emergencies or their relatives, past andpresent staff at the trust, and staff at otherorganisations. We reviewed the case notes ofmore than 30 patients who were admitted asemergencies and subsequently died. Weexamined over 1,000 documents includingpolicies, reports, audits and records ofmeetings.

Synopsis of events leading to ourdecision to investigateDuring the summer and autumn of 2007, theHealthcare Commission became aware,through its programme of analysis of mortalityin England, of a number of apparently highmortality rates for specific conditions oroperations at the trust.

In our work on mortality, we recognise thatsome ‘alerts’ (that is, indications that patients

may be exposed to greater than expected risk)can be due to errors in the data or toinsufficient adjustment for other factors, so ateam of analysts assesses each case toestablish whether there are sufficientconcerns to follow up with a trust. If we dofollow up an alert, we will initially ask a trustto provide further information. In many cases,this is enough to satisfy us that no furtheraction is needed. We can escalate a case ifconcerns about the safety of patients have notbeen adequately addressed, or we think thesehave not been properly recognised by thetrust.

In this investigation, further analysis showedthat the trust consistently had a high mortalityrate for patients admitted as emergencies,which it could not explain.

The rate had been comparatively high forseveral years, but the trust had notinvestigated this. In April 2007, Dr Foster’sHospital Guide showed that the trust had ahospital standardised mortality ratio (HSMR)of 127 for 2005/06, in other words more deathsthan expected. The trust established a groupto look into mortality, but put much of itseffort into attempting to establish whether thehigh rate was a consequence of poor recordingof clinical information.

The response of the trust to our requests forinformation contained insufficient detail tosupport its claim that the alerts were due toproblems with its recording of data, and notproblems with the quality of care for patients.This response, and the concerns from localpeople about the quality of care, led theCommission to decide that a full investigationwas required.

Our key findings are summarised below andset out in full in the body of the report.

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The views of patients and relatives atthe trustWhen we announced the investigation, we hadan unprecedented response. In all, 103patients and relatives contacted us. Of these,99 were critical of, or had had a poorexperience at, the trust. The main areas ofconcern they raised were A&E, the emergencyassessment unit and medical wards 10, 11 and12. Concerns were also expressed about somesurgical wards. A major concern expressed bypatients and relatives related to poorstandards of nursing care.

Although we recognise that this was not astatistically representative sample of patientsand relatives, their concerns reinforced whatwe found through observations, reviews ofcase notes, complaints and interviews –disorganisation, delays in assessment andpain relief, poor recording of important bodilyfunctions, symptoms and requests for helpignored, and poor communication withpatients and families.

In the Healthcare Commission's 2007 survey ofinpatients (the latest national survey available),the trust was in the worst 20% for 39 out of 62questions. This was a poor result. The trustwas in the worst 20% for overall standards ofcare and whether patients felt that they weretreated with respect and dignity in the hospital.

Mortality rates at the trustThrough our programme to analyse mortalityrates in England, we received anunprecedented 11 alerts about high mortalityat the trust, four of these after theinvestigation was launched. Six came from theDr Foster Research Unit at Imperial College,London, as part of its analysis of data, and fivefrom the Commission’s own internalsurveillance of data from all trusts. Details ofthe alerts are set out in appendix E.

The alerts at the trust were wide-ranging andsuggested a general problem with regard tomortality. We considered data across the trust,which showed that mortality was high asregards emergency admissions, but not forelective admissions.

Our analysis focused on patients aged 18 andover who were admitted as emergencies. Theresults were ‘standardised’ (that is, madecomparable with each other by taking accountof various factors) for a number of factors,including age, sex and the type of condition thatthey had when admitted to the hospital. SinceApril 2003, the trust’s standardised mortalityratio (SMR) had been consistently higher thanexpected. If outcomes were the same as wouldbe expected when compared with similartrusts, the SMR would be 100. For the threeyears from 2005/06 to 2007/08, the trust’s SMRfor patients admitted as emergencies aged 18and over varied between 127 and 145.

Looking at the three financial years covered bythe investigation, we conducted a statisticalanalysis of the SMRs to examine to what extentthey could have been due to random variation.We concluded that, for the three years weexamined, there was a less that 5% probabilitythat the high mortality rates at the trust forpatients admitted as emergencies aged 18 orover were due to chance.

Standardised mortality was found to be highacross a range of conditions including thoseinvolving the heart, blood vessels, nervoussystem, lungs, blood and infectious diseases.Our full investigation, including visits to thetrust, examination of documents and wide-ranging interviews, has led us to conclude thatthere were systemic problems across thetrust’s system of emergency care.

The trust’s arrangements for thecollection, reporting and use of clinicalinformationThe trust had a long history of poor informationabout its services. The accuracy of coding ofinformation (that is, the system for cataloguingtypes of surgical and other interventions) hadbeen poor, but had improved since 2007. Thelog of activity in theatres had been badlymaintained and it was not possible to matchinformation between systems, such as thetheatre log and the national Hospital EpisodeStatistics data. Individual patients’ data couldnot be tracked or linked in these differentsystems.

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Although Dr Foster’s analysis showed that thetrust had the fourth highest hospitalstandardised mortality ratio (HSMR) in Englandfor the three-year period 2003-2006, the trustonly began to monitor clinical outcomes afterthe publication of the high rate by Dr Foster in2007. The trust established a group to considermortality, but considered that poor coding wasthe likely explanation for the high rate.

We found that, when challenged, neither thetrust nor individual consultants could producean accurate record of their clinical activity oroutcomes for patients. This meant that wecould not analyse the volume of surgical workand its outcomes.

Management of patients requiringemergency care

A&E and the emergency assessment unit

The detailed evidence for these findings isoutlined in the section in this report on theA&E department and the emergencyassessment unit (EAU). It came from a widerange of sources including interviews withstaff, relatives and patients, observations,reviews of case notes, complaints, trustdocuments and external reports.

When we visited the A&E department in May2008, the initial evidence raised seriousconcerns. We held an urgent meeting with thechief executive and followed this immediatelywith a formal letter requiring urgent action.

The trust did not have clear protocols andpathways for the management of patientsadmitted as emergencies. The A&Edepartment was understaffed and poorlyequipped. There were too few nurses to carryout an immediate assessment of patients. Thiswas left to the receptionists, who had noclinical training. The patients in the waitingroom could not be seen from the receptionarea. The department lacked essentialequipment, such as sufficient defibrillators forevery resuscitation trolley.

The nurses in A&E had not had enough trainingand development, and leadership had beenweak. Patients often waited for medication, pain

relief and wound dressings. There were delaysin scanning patients out of normal hours. Themost senior surgical doctor in the hospital after9pm was often junior and inexperienced.

There were too few consultants to provide on-call cover all day, every day. There were toofew middle grade doctors. The junior doctorswere not adequately supervised, and wereoften put under pressure to make decisionsquickly in order to avoid breaches of the targetfor all patients to be seen and moved fromA&E in four hours. For the same reason,patients were sometimes rushed from A&E tothe EAU without proper assessment anddiagnosis, or they were moved to the ‘assessand treat’ area, even though staff were notformally allocated to the area and patientswere not properly monitored there.

The EAU was large, with a poor layout, makingit difficult for nurses to see patients. It was busyand frequently chaotic. It was understaffed, andcommunication was often poor between nursesand patients, and nurses and doctors.

During 2007/08, the nurses had little in-service training. Not all the nursing staff hadthe correct skills to observe and care for thevariety of patients admitted as surgical andmedical emergencies. On the bays withcardiac monitors, the nurses had not beentrained to read the monitors. On occasions,the equipment was turned off.

Observations of patients were not carried outas they should have been and poor recordswere kept of patients’ intake and output offluids and food. Patients sometimes receivedincorrect medication or did not get theircorrect medication in a timely manner, if atall. There was poor compliance with generallyaccepted standards of practice in the controlof infection.

Patients admitted as medical emergencies

The detailed evidence for these findings isoutlined in the section on medical admissions.It included interviews with staff, relatives andpatients, observations, complaints, trustdocuments, national surveys and externalreports.

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For patients admitted to the medical wards,there was sometimes poor communicationwith, and handover from, the EAU. Care wasreported to be good for patients with heartattacks on the acute coronary unit, althoughthere were problems with the cardiacmonitors. However, because of lack of beds onthe coronary unit, some patients with heartattacks remained in the EAU and were nursedin a non-specialist area.

The reconfiguration of the medical beds onfloor two and associated changes in nursingstaff had led to the creation of clinical areasthat were poorly managed and understaffed.

The care of patients was unacceptable. Forexample, patients and relatives told us thatwhen patients rang the call bell because theywere in pain or needed to go to the toilet, it wasoften not answered, or not answered in time.Families claimed that tablets or nutritionalsupplements were not given on time, if at all,and doses of medication were missed. Somerelatives claimed that patients were left,sometimes for hours, in wet or soiled sheets,putting them at increased risk of infection andpressure sores. Wards, bathrooms andcommodes were not always clean.

Nurses often failed to conduct observationsand identify that the condition of a patient wasdeteriorating, or they did not do anythingabout the results.

There was only one bay, with four beds, forpatients with acute stroke. This wasinsufficient for the number of patients. Therewas no facility on the respiratory ward fornon-invasive ventilation. There had been anumber of problems with arrangements forresuscitation, including some seriousincidents involving the contents ofresuscitation trolleys. The bleep system forthe management of cardiac arrests did notwork effectively on several occasions. Mobilephones had to be used as a contingency.

Patients admitted as surgical emergencies

The detailed evidence for these findings isoutlined in the section on patients admitted in

an emergency with surgical problems ortraumatic injuries. It included interviews withstaff, relatives and patients, observations,reviews of case notes and inquest summaries,trust documents and external reports.

Many doctors and nurses working in surgeryconsidered that staff on the EAU and onmedical wards did not have the right trainingand skills to look after surgical patients.

The general surgeons did not work welltogether and there were few agreed protocolsin surgery. This meant that patients needingemergency operations out of normal hoursmight receive different care and a differentoperation to that received from 9am to 5pm,Monday to Friday.

There were not enough doctors on duty out ofhours, and the most senior surgical doctorafter 9pm at night could be quite inexperienced.

In line with local understanding, theambulance service took most, but not all,patients with severe or multiple trauma toother hospitals with specialised traumaservices. For this reason, there was no traumateam at the trust. However, some staff wereconcerned that nurses on the EAU did nothave the right training to look after thosepatients with traumatic injuries (such asbroken limbs) who were admitted to the trust.In addition, the unit did not have equipment fortraction or specialist hoists. We noted that, attimes, there were too few staff to open asufficient number of critical care beds.

For patients requiring emergency surgery, therewas only one list for theatre at weekends. Therewas no system to assign priority to cases. Oftenemergency caesarean sections or surgicaloperations (such as removing an appendix)would take priority. This meant that patientswith a broken hip might have to wait from Fridayto Monday or Tuesday to have their operation.This inappropriate management meant that, forseveral days, these patients would not beallowed to eat or drink for many hours. Onsome occasions, patients who were designatedas ‘nil by mouth’ were also inadvertently notgiven their essential medication.

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From our review of case notes, from inquestsand from findings from the alerts that theHealthcare Commission received on mortality,we noted a number of cases where patientshad developed clots in the deep veins of theirlegs or pelvis and died from these clotsbreaking off and blocking the blood flow totheir lungs. The trust did not have effectivearrangements to prevent this or comply withaccepted national guidance.

The care of post-operative patients was poor,such that signs of deterioration were missedor ignored until a late stage. When things wentwrong, the trust was poor at recognisingerrors, reporting serious incidents andlearning lessons.

Review of case notes The Healthcare Commission reviewed the casenotes of 30 patients who had died. Our casereviews were undertaken on a small scale, butnevertheless threw significant light on thearrangements for clinical quality andgovernance prevailing in the trust. We foundthat, in many of the cases, at least one elementof the clinical management or monitoring oftheir condition was unsatisfactory. Areas ofconcern included infrequent reviews ofpatients by doctors, the lack of systematicmonitoring of whether the patients wererecovering or deteriorating, and the failure torespond adequately to signs of deterioration.There was inadequate monitoring to identifycommon complications of surgery.

What were the reasons for the failingsat the trust? It is the view of the Healthcare Commissionthat there were deficiencies at virtually everystage of the pathway of emergency care. Thiscan be illustrated by following the patient’spathway.

When patients arrived in A&E, they wereusually assessed by reception staff with noclinical training, before waiting in an area outof sight of the staff in reception. There was noregular check by nursing staff of the patients

in the waiting room. Some essentialequipment, such as cardiac monitors, wasmissing or not working. Assessment andtreatment were often delayed.

There were too few doctors and nurses,alongside poor training and supervision, andjunior doctors were put under pressure tomake decisions quickly without advice andsupport from more senior doctors. Doctorswere moved from treating seriously ill patientsto deal with those with more minor ailments,in order to avoid breaching the four-hourwaiting time target. Patients were moved tothe clinical decision unit to ‘stop the clock’ butwere then not properly monitored, since thisarea was not staffed. Patients had to wait formedication, pain relief, wound dressings andantibiotics. There was only a relatively juniordoctor available after 9pm to give advice onsurgical patients. There was no specialisttrauma team. In summary, the care andassessment of patients fell well belowacceptable standards.

Sometimes patients were rushed to theemergency assessment unit (EAU) withoutproper assessment or discussion, and withoutappropriate specialist care. The EAU was alarge ward with a poor layout. It was busy,noisy and sometimes chaotic with too fewnurses. Many of the nurses did not understandthe cardiac monitors and did not always carryout observations adequately to identify whethera patient’s condition was deteriorating. Therewere many instances of patients not receivingthe medication they needed.

There were too few beds for patients who hadhad a stroke, not all patients with heartattacks went to the acute coronary unit, therewas no non-invasive ventilation on therespiratory ward, and critical care beds werenot always available. The medical wards onfloor two were seriously understaffed andthere were grave concerns about thestandards of nursing care.

There were too few theatre sessions atweekends and consequent delay in getting totheatre, especially for trauma patients, andsome patients did not get essential

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medication. Post-operative complications werenot always recognised.

Surgical practice was idiosyncratic,relationships were poor and there was littlemultidisciplinary team work. There wereconcerns about the level of cover by medicalstaff at night and at weekends.

Across the trust, there were shortcomings inresuscitation and arrangements to avoidpotentially fatal blood clots were inconsistent.There was a shortage of critical care beds andconcern about access to medical advice fromcritical care specialists.

It is our view that all these factors would havecontributed to a poor outcome for patients.

The trust’s approach to its mortality rate One of the aims of the investigation was toclarify how the trust investigated itsapparently high mortality rates.

The trust assured us that its mortalityoutcomes group undertook reviews of samplesof case notes of patients who had died inhospital during particular periods. This was toascertain whether the deaths were expected(unavoidable) and whether there were anyquestions arising about the quality of careprovided to the patients.

Our scrutiny of their information, however,found that the reviews had not beensufficiently objective or robust. Moreover, thecase notes revealed some sub-standardpractice, which should have been identifiedand learned from.

Arrangements for governance and riskThe chief executive inherited a structure ofgovernance that did not function effectively.Since 2005, there had been considerable changein the structure and responsibilities relating togovernance and the management of risk.

The trust’s system for identifying seriousuntoward incidents was poor, with failures toreport some incidents and opportunities tolearn lessons missed. Other incidents that were

reported by staff consistently highlightedproblems relating to the levels of staff, poorcare for patients, and poor handovers whenpatients were moved from one ward to another.Many of these issues required consideration andresolution at a strategic level, but were rarelyconsidered by the board or by its governanceand risk sub-committees. There was nosystematic mechanism to follow up any actionsrequired or to share lessons.

The medical and surgical divisions failed toresolve problems such as ‘nil by mouth’, cardiacmonitors, the cardiac bleep system, portablesuction, and preventing blood clots andpulmonary embolism. Often these problemswere listed on the corresponding risk register,but little effective action had been taken.

There were many complaints from patients andrelatives about the quality of nursing care.These primarily related to patients not beingfed, call bells not being answered, patients leftin soiled bedding, medication not beingadministered, charts not being completed, poorhygiene and general disregard for privacy anddignity. Worryingly, the trust’s board appeared tobe largely unaware of these. In the reports seenby the board, these complaints were groupedinto, and effectively lost in, categories such as“communication” or “quality of care”.

The trust reported it had made efforts to engageclinical staff, but many senior doctors whom wespoke to considered that the trust was driven byfinancial considerations and did not listen totheir views. They gave credit for the trust havinga clear direction, but said that inflexible ways ofimposing change had left many feelingmarginalised.

Although most non-clinical staff thought thatcare at the trust was good, the majority ofdoctors we interviewed would not have beenhappy for a relative to be treated at the trust.In a 2006 survey, only 27% of staff said theywould be happy to be cared for at the trust,compared with 42% nationally.

The trust generally performed poorly onclinical audit. There was no one taking thelead for clinical audit for a year and the trust-

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wide group did not meet at all during thisperiod. When audits were carried out, therewas no robust mechanism to ensure thatchanges were implemented. When re-auditswere required, they were often notundertaken, even if they had beenrecommended by a Royal College. The trustdid not participate in many of the nationalaudits run by the specialist societies.

The trust did not have an open culture whereconcerns were welcomed. Overall, the systemthat was intended to bring clinical risk to theattention of the board did not functioneffectively, and the board appeared to beinsulated from the reality of poor care foremergency patients.

The trust’s board and outcomes forpatientsThe board stated that the care of patients hadalways been a priority. However, noinformation on clinical outcomes went to theboard until the publication by Dr Foster of thehospital standardised mortality ratio (HSMR)in April 2007. Even then, it went only to theprivate part of the meeting.

No annual report on the control of infectionwent to the board until July 2007, and that onlywent to the private part of the meeting.

The routine reports on performance that went tothe board were at so high a level that they didnot identify the failings in care of patients. Theinformation on complaints and incidents wasoften incomplete, or so summarised that it leftnon-executives at a disadvantage in being ableto perform their role to scrutinise and challengeon issues relating to the care of patients.

Informing the public The trust’s board preferred to discuss mattersin private, even those that were notconfidential or commercially sensitive. It didnot discuss the Dr Foster HSMR or the alertsfrom the Healthcare Commission in public.

An outbreak of Clostridium difficile (C. difficile)occurred in the spring of 2006, and rates

continued to be high during that year, but thetrust did not report or acknowledge in publicthat it had an outbreak.

The actions of the trust’s boardThe year 2006/07 was a challenging one forthe NHS, as trusts were required to achievefinancial stability. That year, the trust set itselfa challenging agenda to meet national targetsfor cost improvement, stabilise its finances,and become an NHS foundation trust. Thetrust set a target of saving £10 million,including a planned surplus of £1 million. Thisequated to about 8% of turnover. To achievethis, over 150 posts were lost. Although thestated intention was to minimise the loss ofclinical staff, the number of nurses wassignificantly reduced. This was in a trust thatalready had comparatively low levels of staff(see pages 90-93 for details) and at a timewhen nurses felt they were poorly supportedas a profession.

The combination of the reorganisation of wards,the reduction of beds (more than 100 fewerbeds between 2005 and 2008, 18% of the total)and the loss of staff meant that the care ofpatients was further compromised. Areas withlongstanding problems, such as A&E, were notgiven sufficient attention by managers.

The board claimed that its top priority was thesafety of patients. However, even thoughclinical problems were well known, and thetrust declared a financial surplus in 2006/07, itdid not seek to redress the staffing problem ithad exacerbated by reducing the number ofnurses. The evidence suggests that the toppriority for the trust was the achievement offoundation trust status. The failure of the trustto resolve the problems in A&E and to invest instaff is not consistent with the trust doing itsreasonable best to provide a safe and effectiveservice for patients.

The fact that the organisation concentratedmainly on clinical coding as the explanationfor poor outcomes suggests that there was areluctance to acknowledge, or even consider,that the care of patients was poor.

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It was clear from the minutes of the trust’sboard that it became focused on promotingitself as an organisation, with considerableattention given to marketing and publicrelations. It lost sight of its responsibilities todeliver acceptable standards of care to allpatients admitted to its facilities. It failed topay sufficient regard to clinical leadership andto the experience and sensibilities of patientsand their families.

Developments since the investigationwas announcedIt is, of course, impossible to determine whatactions would have been taken by the trust ifthere had not been an investigation. Theagreement at the end of March 2008 to fundthe deficit in the numbers of nurses was takenafter the board knew there was going to be aninvestigation.

Since January 2008, there has been a net gainof 46 qualified nurses and 51 healthcaresupport workers. The trust has increased thenumber of matrons from three to 12. However,in November 2008, the trust’s board noted thatfurther recruitment had been stopped becauseof actual and anticipated financial pressures,although the trust was 40 nurses below thepreviously agreed establishment. The trust,though, has told us that the board has notstopped recruitment and will, as part of the2009/10 business plan, revisit the review of theestablishment and take a view on recruiting tothe outstanding posts.

When we expressed concerns to the trust, itwelcomed them, responded positively andbegan to take action. The trust received formalnotification of our concerns about the A&Edepartment on 23 May 2008. It immediatelyset up a steering group for emergency care.Significant progress has been made, but thereis still a need for further improvement. Twonew consultants have been appointed, but theoriginal consultant went on long-term sickleave. The middle grade rota is now fullystaffed and there is a programme of trainingfor junior and middle grade doctors. Thenumber of nurses increased, but many of the

new staff were inexperienced and there wasstill only one band seven nurse. A new modelof care was introduced in the autumn of 2008.Triage is in place for 12 hours a day.

Ward-based training on the use of modifiedearly warning scores (MEWS) was introducedin the autumn of 2008. A training package wasalso agreed to ensure that staff werecompetent to use cardiac monitors. A four-bedded surgical assessment unit was opened.Two additional beds were opened on thetrauma ward. The trust is reviewing theprovision of emergency theatre lists atweekends. Additional sessions have beenarranged at short notice when necessary.

The mortality group has become the clinicaloutcomes group and is chaired by the chiefexecutive. The trust reports that it is takingaction in order to ensure that changes happenfollowing complaints. Early signs are thatmortality for emergency admissions is lowerthan previously, although the definitive figuresfor 2008 are not available yet.

The trust deserves credit for the improvementin the prevention and control of infection and itwas recently found to comply with the hygienecode.

Overall conclusion about the trustThis was a small trust trying to support arange of specialties. It had become afoundation trust and improved its finances.However, it did not have a grip on operationaland organisational issues, with no effectivesystem for the admission and management ofpatients admitted as emergencies. Nor did ithave a system to monitor outcomes forpatients, so it failed to identify high mortalityrates among patients admitted asemergencies. This was a serious failing.

When the high rate was drawn to the attentionof the trust, it mainly looked to problems withdata as an explanation, rather thanconsidering problems in the care provided.The trust’s board and senior leaders did notdevelop an open, learning culture, informthemselves sufficiently about the quality of

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11Investigation into Mid Staffordshire NHS Foundation Trust

care, or appear willing to challengethemselves in the light of adverse information.

The clinical management of many patientsadmitted as emergencies fell short of anacceptable standard in at least one aspect ofbasic care. Some patients, who might havebeen expected to make a full recovery fromtheir condition at the time of admission, did nothave their condition adequately diagnosed ortreated. As late as September 2008, we foundunacceptable examples of assessment andmanagement of patients. The trust was poor atidentifying and investigating such incidents.

In the trust’s drive to become a foundationtrust, it appears to have lost sight of its realpriorities. The trust was galvanised intoradical action by the imperative to save moneyand did not properly consider the effect ofreductions in staff on the quality of care. Ittook a decision to significantly reduce staffwithout adequately assessing theconsequences. Its strategic focus was onfinancial and business matters at a time whenthe quality of care of its patients admitted asemergencies was well below acceptablestandards.

The trust deserves credit for progress oninfection control and for responding positivelyto the concerns of the Healthcare Commission.

The role of external organisationsAlthough South Staffordshire Primary CareTrust (PCT) commissioned services from thetrust, it was initially distracted by theorganisational change following the mergerthat created the PCT in 2006, and thenfocused on the number of patients treated andthe cost. They had few measures of the qualityof care or outcomes at the trust, and relied inpart on external measures such as theHealthcare Commission’s annual healthcheck. Once the concerns of a campaign groupwere drawn to their attention, the PCT tookaction to address the individual concerns ofpatients and relatives, and to investigate andhelp to improve the quality of care at the trust.

West Midlands Strategic Health Authority(SHA) had also been created in 2006 through amerger and it too suffered from theaccompanying loss of organisational memory.There was nothing to alert the SHA toconcerns about the quality of care until thepublication by the Dr Foster unit of the highhospital standardised mortality ratio in thespring of 2007. The SHA was reassured by thetrust that it was investigating mortalityappropriately.

We thought that information from the coronerwould be useful for the investigation. We weredisappointed that he declined to provide uswith any information about the number ornature of inquests involving the trust.

The national picture and lessons forother organisationsA number of the findings of this investigationin respect of acute hospital care arepotentially relevant to the whole NHS. Theseinclude the need for:

• Trusts to be able to get access to timelyand reliable information on comparativemortality and other outcomes, and fortrusts to conduct objective and robustreviews of mortality rates and individualcases, rather than assuming errors in data.

• Trusts to identify when the quality of careprovided to patients admitted asemergencies falls below acceptablestandards and to ensure that a focus onelective work and targets is not to thedetriment of emergency admissions. Caremust be provided to an acceptable standard24 hours a day, seven days a week.

• Trusts to ensure that a preoccupation withfinances and strategic objectives does notcause insufficient focus on the quality ofpatients’ care.

• Trusts to ensure that systems for governancethat appear to be persuasive on paperactually work in practice, and informationpresented to boards on performance(including complaints and incidents) is not so

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summarised that it fails to convey theexperience of patients or enable non-executives to scrutinise and challenge onissues relating to patients’ care.

• Senior clinical staff to be personallyinvolved in the management of vulnerablepatients and in the training of juniormembers of staff, who manage so much ofthe hour-by-hour care of patients.

• Trusts to identify and resolve shortcomingsin the quality of nursing care relating tohygiene, provision of medication, nutritionand hydration, use of equipment, andcompassion, empathy and communication.

• Good handovers when reorganisations andmergers occur in the NHS.

• PCTs to ensure that they have effectivemechanisms to find out about theexperience of patients and the quality ofcare in the services that they commission.

RecommendationsIn this report, we have drawn together thedifferent strands of numerous, wide-rangingand serious findings about the trust which,when brought together, we consider amountto significant failings in the provision ofemergency healthcare and in the leadershipand management of the trust.

We have therefore written to Monitor, theregulator of NHS foundation trusts, inaccordance with the Health and Social Care(Community Health and Standards) Act 2003(s53(6)), to highlight these significant failings.We had previously raised concerns withMonitor about the leadership of the trust, andwe note that both the chairman and chiefexecutive have left the trust in the two weeksleading up to the publication of this report.

Irrespective of the above, we expect the trustto consider all aspects of this report, includingall our findings, which detail serious failings atdifferent levels and across different parts ofthe trust’s services. Here, we highlight whereaction is particularly important.

Action by the board

The trust’s board must ensure that there is asystematic means of monitoring rates ofmortality and other outcomes for patients.This information should inform the board’sdiscussions about the quality of services at thetrust, and also inform action taken to improveoutcomes for patients.

More generally, the trust’s board needs toreflect on its arrangements for overseeing thequality and safety of clinical care within thetrust. In particular, how the trust:

• Develops and promotes an open, learningculture.

• Collects and reports informationaccurately, both internally and externally,and in sufficient detail.

• Identifies and mitigates risks to the safetyof its patients.

• Identifies correctly, and then reports,investigates adequately and learns fromserious incidents and unexpected deaths.

• Learns from, and ensures that necessaryimprovements are made followingincidents, near misses and complaints.

• Engages clinicians and develops effectiveclinical audit.

• Considers and acts on the views andexperiences of patients who use the trust’sservices.

A&E department

Recent improvements to the emergencydepartment – confirmed by a recentunannounced visit we made to the trust – mustbe sustained and extended to ensure that theservice is safe, that it meets the needs ofpatients, and that the department isadequately staffed and equipped at all times.

Investigation into Mid Staffordshire NHS Foundation Trust12

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Staffing and capacity

The trust must continue the work it hasstarted to recruit additional nursing andmedical staff, to ensure that care provided topatients throughout the trust, including atnight and at weekends, is safe and keeps toaccepted standards.

The trust needs to review the training andsupervision of its nursing staff and juniordoctors, to ensure that they are undertakingappropriate roles, are confident and clearabout the expectations placed on them, andare receiving all necessary support.

The trust must ensure adequate availability oftheatre sessions to ensure that it is able tohandle demand in an emergency withoutdelay, and has an effective means ofdetermining which cases requiring emergencysurgery should receive priority.

The trust must ensure that there is adequateaccess for clinical staff to advice and supportfrom medical staff in the critical care(intensive care) service, and ensure this isindependent of the availability of beds in thecritical care unit.

Standards of care

The trust must ensure that its medical andnursing staff deliver basic aspects of care,such as reviewing patients on a regular basis,monitoring their condition, and identifying andmanaging any complications that may arise.The trust must ensure that there is timelyreview of patients by senior doctors.

In the light of specific findings in this report,the trust needs to audit its arrangements forand, where appropriate, equipment used inrelation to: medication (particularly onadmission and for patients who are ‘nil bymouth’); the resuscitation of patients; non-invasive ventilation; cardiac monitoring; andanticoagulation.

National recommendations

Analysis undertaken in this and other trustsshows worrying variations across the NHS in

the quality of coding of clinical outcomes, andvariations in the extent to which statisticalinformation is used to monitor the quality oflocal services and inform decisions at a seniorlevel within NHS trusts.

This is of concern in a modern, information-driven health service where the interpretationand use of data is a fundamental means ofimproving clinical care. We recommend formallythat all NHS trust boards have access tocomparative data on outcomes for patients,including mortality, that is accurate, completeand as up-to-date as possible.

While recognising the challenges in ensuring thatmortality rates are accurate and expressed in away that does not cause unnecessary alarmamong patients, or lead to unhelpfully risk-aversebehaviour among clinicians, we believe thatmortality rates can be published in a meaningfulway to help patients to make informed choicesabout the quality of clinical care.

Boards of NHS trusts need to be focused at alltimes on the safety and quality of the servicesprovided to patients. This includes havinginformation available to boards that properlycaptures the experience of patients, so that non-executives can scrutinise and challenge the carereceived by patients.

The NHS and appropriate professional andeducational bodies need to examine why theexperience of patients on general wards in truststhat we have investigated continues to be of a poorstandard, and take urgent action to improve thequality of nursing care in these areas.

PCTs need to develop more effectivemechanisms to learn about the quality of care,the actual experience of patients and theoutcomes of care in services that theycommission, and give more priority to thisaspect of commissioning.

The NHS needs to ensure effective handoverswhen reorganisations and mergers occur, sothat information on services is transferredeffectively to the new organisation.

13Investigation into Mid Staffordshire NHS Foundation Trust

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Introduction

The Healthcare Commission is empowered bysection 52(1) of the Health and Social Care(Community Health and Standards) Act 2003 toconduct investigations into the provision ofhealthcare by or for an English NHS body.

The Healthcare Commission usuallyinvestigates when allegations of seriousfailings are raised, particularly when there areconcerns that the safety of patients might beat risk. Our full criteria for deciding whetherto conduct an investigation are set out inappendix A.

This investigation began in April 2008 and wasundertaken following concerns aboutapparently high mortality rates and poorstandards of care at Mid Staffordshire NHSFoundation Trust. It aimed to establishwhether the mortality rates for patientsadmitted as emergencies were high, to assessthe care provided to those patients, and toestablish whether the trust's systems andprocesses for the identification and preventionof poor outcomes for those patients wereadequate.

The Healthcare Commission routinely reviewsdata about mortality rates at NHS trusts andfollows up with individual trusts where there iscause for concern. Initial analysis of data fromMid Staffordshire NHS Foundation Trustcompared with other trusts, and subsequentdiscussions with the trust, caused theHealthcare Commission to be concerned aboutthe effectiveness of the trust's own systemsfor monitoring mortality rates among patients.

As a result of a number of concerns aboutmortality for individual procedures, the poorresponse to information requests made to thetrust, and an apparently high mortality rate foremergency admissions, a decision was madeto pursue the concerns through a screeningprocess called an initial consideration.

However, following this, a number of concernsstill remained:

• The trust appeared to have a highernumber of deaths than anticipated forpatients admitted as emergencies.

• There were doubts about the effectivenessof the trust's own systems for monitoringmortality rates, and we were not satisfiedwith the trust’s explanation for the highmortality.

• There was considerable local concernabout the care of patients, particularlyelderly patients, that was threateningpublic confidence in the service.

• We were unsure of the trust's willingnessto cooperate and its capacity to investigateand resolve the matter.

These concerns were noted by the HealthcareCommission's investigation committee, whichagreed that a full investigation was necessary.

Terms of referenceThe Healthcare Commission's investigationscommittee agreed the terms of reference forthe investigation in April 2008.

The investigation was into the circumstancessurrounding the mortality rates at MidStaffordshire NHS Foundation Trust sinceApril 2005 and the effectiveness of the trust'sown systems for monitoring mortality ratesamong patients. It would aim to establishwhether the trust was maintaining appropriatestandards in the management, provision andquality of its services.

This included an examination of:

• The trust's arrangements for the collection,reporting, analysis and use of clinical data.

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• Mortality rates at the trust, and the abilityof the trust's information systems toprovide an accurate picture of mortalityrates, so as to identify any potentialproblems.

• Arrangements at the trust to ensure thatpatients are safe and that there is a goodstandard of care, particularly with regard toolder patients.

• The governance arrangements within thetrust and in the local NHS to protect thesafety of patients and scrutinise the qualityof the care provided by the trust.

• Any other matters that the HealthcareCommission considers arose out of, orwere connected with, the matters above.

The investigation focused on information andevents since April 2005 in relation to thesematters.

Key elements of the investigationOur investigation team worked with a team ofexternal expert advisers and the membershipis listed in appendix B.

During the investigation, we:

• Made a number of scheduled andunannounced visits to the trust to interviewstaff in relation to the investigation, and toobserve wards and clinical areas in thetrust.

• Conducted over 300 face-to-face andtelephone interviews with past and presentstaff from the trust, representatives fromlocal organisations representing patients,people who had used services at the trustand their relatives, and members of thepublic (see appendix C for further details).

• Reviewed over 30 sets of individual casenotes of patients who had been admitted asemergencies and who had subsequentlydied.

• Analysed more than 1,000 documentsprovided by the trust and otherorganisations (see appendix D for asummary of sources of information andevidence).

This reportSince the concerns about mortality in the trustinvolved patients admitted as emergencies, inthis report we first describe emergencyadmissions and look at the guidance ondiagnosis and care of these patients.

The report then describes the context of thetrust. It looks at the information that isavailable nationally about outcomes of care forpatients admitted as emergencies and thework of the Healthcare Commission inreviewing these outcomes. It considersoutcomes for patients admitted asemergencies to the trust and how the trustmonitored these. The report also reviews thecare that these patients received.

We go on to look at the pathway for patientsadmitted as emergencies to the trust,beginning with A&E, then the emergencyassessment unit, then the medical andsurgical wards. We do not consider childrenadmitted as emergencies or maternityadmissions.

The report considers the factors that wereassociated with outcomes for patients, inclinical areas and at strategic levels. Lastly, itlooks at the role of other relevant agencies.

This report makes a number ofrecommendations in relation to the care andmanagement of patients admitted asemergencies, and the monitoring of data onoutcomes for patients.

The Healthcare Commission is responsible forthis report and for undertaking a formalreview of progress against therecommendations. The action plan will beavailable on our website. Monitor, theregulator of foundation trusts, will beresponsible for ensuring that Mid StaffordshireNHS Foundation Trust takes action inresponse to our investigation and will monitorprogress against the action plan.

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Mid Staffordshire NHS Foundation Trust (thetrust) provides services for patients on twosites: Stafford Hospital and Cannock ChaseHospital. These hospitals are about 10 milesapart. Stafford Hospital opened in 1983 and in2008 had approximately 354 inpatient beds.Cannock Chase Hospital opened in 1991 andhad approximately 115 inpatient beds. Thereare around 3,000 employees working in thetwo hospitals.

Stafford Hospital is an acute hospital offeringa range of non-specialist medical and surgicalservices, including some specialty wards anda 24-hour accident & emergency department.Cannock Hospital has orthopaedic services forplanned surgery, a nurse-led minor injuriesunit, elderly care services and rehabilitationfacilities. There have been various structuralrefurbishments across both sites in the pastfew years including, in 2007, the A&Edepartment.

The trust serves a population of around320,000 people from Stafford, Cannock,Rugeley and the surrounding rural areas. It isestimated that 21% of the population are overthe age of 60. The 2001 census forStaffordshire showed that life expectancy (atbirth) was slightly greater than the nationalaverage, general health was better than boththe national average and regional (WestMidlands) average, and unemployment waslower than both the national and regionalaverages. Staffordshire has a lower proportionof non-white population than both the nationaland regional averages.

The current chief executive came to the trustas interim chief executive in August 2005 andwas appointed formally to the post in February2006. The chairman of the trust's board hasbeen in post since October 2004. During thefirst 18 months after the chief executive was

appointed, a number of structures and postswere changed. These included theappointment of a director of nursing, a chiefoperating officer and clinical heads ofdivisions. All the executive team changed, withthe exception of the director of finance whoretired in 2008. The supporting structures forthe executive team were also revised.

Since October 2006, the trust has providedservices commissioned by South StaffordshirePrimary Care Trust (PCT). South StaffordshirePCT was created at that time by a merger offour PCTs: Burntwood, Lichfield & Tamworth,Cannock Chase, East Staffordshire and SouthWestern Staffordshire. The PCT is responsiblefor organising primary care and communityhealth services for the local population, andcommissioning hospital care. The trust alsoprovides services to other PCTs.

From July 2006, the trust has been in the areacovered by the West Midlands Strategic HealthAuthority (SHA) following a merger involvingShropshire & Staffordshire, Birmingham & theBlack Country, and West Midlands SouthSHAs. The role of strategic health authoritiesincludes establishing and managing annualperformance agreements with PCTs and NHStrusts.

The trust was awarded foundation trust statuson 1 February 2008. NHS foundation trusts areindependent public benefit corporations.Although remaining part of the NHS, they arefree from central Government control and arenot subject to performance management bystrategic health authorities. They are free toretain any surpluses they generate and toborrow in order to support investment.

Authorised and monitored by the regulatorMonitor, foundation trusts also continue to beassessed through the HealthcareCommission's annual health check. Monitor

The trust’s history and role

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17Investigation into Mid Staffordshire NHS Foundation Trust

was established in January 2004 and acts as aregulator for foundation trusts. It isresponsible for approving new applications forfoundation trust status, which it grants onceapproval criteria have been met by theapplicant trust. Once a foundation trust isestablished, Monitor reviews the trust'sactivities to ensure that they comply with therequirements of their terms of authorisation.

In 2002, the Healthcare Commission’spredecessor, the Commission for HealthImprovement carried out a clinicalgovernance review of the trust. Its report waspublished in December 2002. The key areasfor action included resolving problemsassociated with high numbers of emergencyadmissions, and ensuring patients were puton appropriate wards with fewer transfers ofpatients between wards. The report noted thatthe number of nurses was a cause forconcern, and that the trust needed to improvethe privacy and dignity of its patients. Thetrust was advised to develop an open andlearning culture. The report also noted thatthe quality of clinical data was poor.

In 2004/05, the trust was awarded one star bythe Healthcare Commission in its annualperformance (star) ratings. In the 2005/06annual health check, the trust was rated bythe Healthcare Commission as having “fair”quality of services and “fair” use of resources.In the following year (2006/07), the trustreceived fair for its quality of services and“good” for its use of resources. In the samereview, the core standards score was “fullymet” after having a risk-based assessmentundertaken by the Commission. The trust wasrated as good against the existing standardsbut “weak” against the new national targetsscore.

The most recent assessment by theHealthcare Commission, for 2007/08 andpublished in October 2008, noted that thetrust was being investigated at the time andwas therefore based largely on the trust'sassessment. The trust was rated as good forquality of services and good for use ofresources. In publishing this assessment, theCommission’s website noted that thisinvestigation was underway and that theassessment would be reviewed in the light ofthe report.

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In this report, we concentrate on emergencyadmissions since it was for patients admittedas emergencies that the trust had a highmortality rate.

What are emergency admissions?Emergency admissions happen when patientsare admitted to hospital as a matter ofurgency. They are not scheduled stays inhospital for planned or routine procedures oroperations. They vary considerably in nature,but generally include the most critically ill orinjured patients in the hospital. Patients maybe sent in by general practitioners (GPs), theymay be brought in by ambulance, or they maydecide to go directly there themselves.

Patients may be suffering from traumaticinjury, for example following a fall, an accidentor a violent attack. Emergencies includepatients with food poisoning, pneumonia,heart attacks and strokes, and patients withacute conditions requiring surgery such asappendicitis or obstruction of the bowel.

The NHS records emergency attendances andadmissions as “unscheduled care”.

Emergency admissions account for over athird of all admissions to hospitals. Statisticsfor England show that there were 4.7 millionemergency admissions in 2006/07.

Over a 10-year period, admissions to hospitalnationally have increased by 15% butemergency admissions have risen by nearly20%. Nationally, the majority of emergencyadmissions (79%) are for medical as opposedto surgical reasons (21%).

The management of patients admittedas emergencies: national guidance andrecommendationsThe Royal College of Physicians, in 2004,recommended that a doctor with theappropriate skills and knowledge in acutemedicine should be present at all times in adepartment receiving acute medicalemergencies. This is because earlyassessment and decisions by a clinician withthe appropriate skills and knowledge are acrucial part of the management of emergencypatients.

In 2005, the Department of Health describedthe management of emergency medical andsurgical admissions as consisting of twostages: assessment and admission. Early andaccurate initial assessment was said to bevital to ensure that patients were admitted tothe appropriate place for the appropriatetreatment at the first time of asking.

In 2007, a report by the National ConfidentialEnquiry into Patient Outcome and Death(NCEPOD), Emergency Admissions – A journey inthe right direction, also recommended thatinitial assessment of patients admitted as anemergency should include a doctor of sufficientexperience and authority to implement anaction plan for the care of the patient.

Following initial assessment, a clear plan fortreatment tailored to their clinical conditionshould be in place for every patient – aprocess emphasised by guidelines producedby the National Institute for Health andClinical Excellence (NICE) in 2007. Subsequentreview and observations are critical ininpatient care as the outcome for patients isaffected by the adequacy of the clinical review.

Following the initial assessment andtreatment of emergency admissions,

Emergency admissions

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subsequent transfer of patients should be to award that is appropriate for their clinicalcondition. NCEPOD in 2007 reported that 93%of patients are generally admitted under theappropriate specialty. Transfers toinappropriate wards may lead to a delay intreatment, which is known to have a negativeeffect on outcomes. Excessive transfers ofpatients between wards should be avoided, asthese are also detrimental to the care andexperience of patients.

It is generally accepted that the earlyinvolvement of a senior clinician or consultantin the management of patients admitted as anemergency can improve the quality of care. Inaddition to the greater ability and experience ofsenior staff, there is concern regarding theability of junior staff to recognise severely ill ordeteriorating patients (see, for example, clinicalguideline CG50 from the National Institute forHealth and Clinical Excellence, 2007).

The timing of a patient's first contact with aconsultant is likely to influence the quality andstandard of care received. The Royal Collegeof Physicians recommended that 90% ofpatients should be reviewed by a consultantwithin 24 hours of admission. However, due tothe nature of emergency admissions, NCEPODin 2007 recommended that the first consultantreview should be within 12 hours ofadmission. Moreover, regular review by aconsultant is important to maintain continuityof care.

Some of the most demanding cases involvepatients who have suffered severe physicaltrauma. Trusts should ensure that a traumateam is available 24-hours a day, seven days aweek. This, according to the NCEPOD reportTrauma: Who Cares? (2007), is essential inresponse to serious injury. A consultant mustlead a team in the management of patientswho have suffered trauma. Due to therelatively low incidence of severe trauma, it isunlikely that every hospital can deliveroptimum care in these circumstances. It is,therefore, essential that there is regionalplanning to organise the delivery of traumaservices.

A patient admitted as an emergency willusually be admitted to a specialist inpatientward or an assessment unit (medicalassessment unit or emergency assessmentunit). Alternatively patients could betransferred to another establishment, orremain under the operational management ofthe emergency department in a clinicaldecision unit (CDU). Clinical decision units arefor patients who require further observationand assessment before a treatment plan canbe developed or a decision made to dischargethem. They are normally short-stay units.

Other relevant recommendations of theNCEPOD report Emergency Admissions – Ajourney in the right direction included:

• Trainee doctors need to have adequatetraining and experience to recognisecritically ill patients and make clinicaldecisions. This is an issue not only ofmedical education but also of ensuring anappropriate balance between a training andservice role, thus exposing trainees toacute clinical problems with appropriatemid-level and senior support for theirdecision making.

• Hospitals that admit patients asemergencies must have access to bothconventional radiology and computerisedtomography (CT) scanning 24-hours a day,with immediate reporting.

• Robust systems need to be in place for thehandover of patients between clinicalteams, with readily identifiable agreedprocedures for handovers based on agreedprotocols. Clinicians should be made awareof these protocols and handovermechanisms.

• A clear plan should be made to monitoreach patient according to their clinicalcondition. This should provide details ofwhat is to be monitored and the frequencyof observations and should be maderegardless of the type of ward to which thepatient is transferred.

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Outcomes for patients and mortality rates

General analysis of outcomesThe use of statistical tools to compareoutcomes across different hospitals anddifferent clinical conditions is a relativelyrecent activity. It has achieved majorprominence in the NHS with the establishmentof the Dr Foster Research Unit at ImperialCollege in London and the associatedcommercial enterprise, Dr Foster Intelligence.Before Dr Foster, monitoring of outcomestended to be focused on specific clinical areasor within individual hospitals – examples inthe NHS include the monitoring of cardiacsurgery outcomes, begun by the Society ofCardiothoracic Surgeons of Great Britain andIreland, and organ transplant outcomesmonitored by NHS Blood and Transplant.

The ability to use data to make nationalcomparisons has only been possible withdevelopments in the recording and provision ofinformation, including improved computerpower, standardised coding, the NHSminimum datasets, payment by results, andother incentives for improving data quality.Nationwide Hospital Episode Statistics (seebox opposite) have been collected in someform since the mid-1980s, but there have beenmarked improvements in their accuracy andreliability over the past 10 years.

For the data to accurately reflect hospitalactivity, there must be clear, accurate and timelyinformation recorded in the patient’s notes;accurate and consistent clinical coding; andclear procedures for collecting and processingthe data. There also needs to be appropriatetraining and accreditation of staff.

Clinical coding is the process whereby thecare given to a patient (usually information ondiagnosis and any procedures carried out),that is recorded in the patient’s notes, istranslated into coded data and entered into

the hospital’s information system. Clinicalcoding therefore depends on a clear record ofthe care given by clinicians.

Many of the tools that are used for monitoringoutcomes in the NHS are adapted from qualitycontrol methods that have been used inindustrial manufacturing since the 1930s. Thereare major challenges in adapting these methodsto healthcare: in particular, accounting for thenatural variation between individuals anddeciding on appropriate thresholds fortriggering a concern about the safety ofpatients. There are also challenges due to thegreat number of processes being monitored andthe subsequent risk of a false alert.

The Healthcare Commission has been involvedwith the measurement of outcomes forpatients since our inception in 2004, andincludes this as part of our annual healthcheck that rates NHS trusts. Analysis thatfeeds into the health check includes the use ofindicators to assess a trust’s compliance withcore standards, and the assessment ofoutcomes against specific national targets (forexample, cancer waiting times and reductionsin MRSA infection rates). We also administerthe annual surveys of NHS staff and patients,and carry out specific service reviews acrossthe NHS (such as the recent reviews ofmaternity services and urgent care).

The Healthcare Commission’s work onhigh mortality ratesIn 2007, we began a formal programme toidentify and follow up apparently highmortality rates in NHS trusts.

Alerts about possible high mortality (alsoknown as ‘outliers’) have been eithergenerated by us from our analysis of HospitalEpisode Statistics or received from other

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21Investigation into Mid Staffordshire NHS Foundation Trust

organisations – the main external sourcebeing the Dr Foster Research Unit at ImperialCollege. A review of our approach to followingup high mortality rates can be accessed onour website.

It is recognised that a large number of thesealerts may be due to errors in the data or toinsufficient adjustment for case mix, so ateam of analysts assesses each case toestablish whether there are sufficientconcerns to follow up with the trust.

If an alert is followed up, the trust will initiallybe required to provide further information andexplanation. In many cases, this has beenenough to satisfy us that no further action isneeded. Cases can be escalated if concernsabout the safety of patients have not beenadequately addressed or we think these havenot been properly recognised by the trust.

Hospital standardised mortality ratioThe hospital standardised mortality ratio(HSMR) is a comparative measure of an acutetrust's overall mortality developed by the DrFoster Research Unit. It does not cover alladmissions, but focuses on a group ofdiagnoses that accounts for 80% of all deathsin hospitals in England.

The HSMR accounts for the case mix ofpatients at the time they are admitted to thetrust, adjusting for a number of factors thatinclude the primary diagnosis, age, sex, ‘co-morbidities’, deprivation and method ofadmission. Co-morbidities are medicalconditions that exist alongside the maindisease or condition for which the patient isbeing treated.

A value for the HSMR of 100 indicatesmortality that is equivalent to what would beexpected, given the case mix. Values greaterthan 100 indicate higher than expectedmortality, and values less than 100 indicatelower than expected.

In the 2007 Dr Foster Hospital Guide, the trustwas classified as having high mortality, with aone-year (2005/06) HSMR of 127 and a three-year (2003-2006) HSMR of 125.

Hospital Episode Statistics is the national dataset for England of the care provided to NHSpatients. HES information is stored as a largecollection of separate records – one for eachperiod of care – in a secure data warehouse.Each HES record contains a wide range ofinformation about an individual patientadmitted to an NHS hospital. For example:

• Clinical information about diagnoses andoperations.

• Information about the patient, such as agegroup, gender and ethnic category.

• Administrative information, such as timewaited and date of admission.

• Geographical information on where thepatient was treated and the area in whichthey live.

The clinical data held in HES have beentranslated from the information recorded byclinicians in patients’ notes into diagnosisand procedure. This is done by clinical codingteams at each trust. It enables consistentcomparisons to be made across all trusts inEngland, and across the world whereverthese codes are used.

Data such as that collected in HES are avaluable source of information, but it isimportant that they are used in context andthat their limitations are recognised.

Hospital Episode Statistics

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Concerns about outcomes at the trust

Initial concerns

The initial concerns about mortality rates atthe trust arose out of the HealthcareCommission’s work to follow up high mortalityrates as described above. Over the period July2007 to March 2008, the Dr Foster ResearchUnit generated four mortality outlier alerts forthe trust and a further three were generatedthrough the mortality outlier surveillance atthe Healthcare Commission. Four more alerts(two by Dr Foster and two by the HealthcareCommission) were generated between thelaunch of the investigation in April 2008 andNovember 2008. Further details on thesealerts can be found in appendix E.

Each of the alerts was analysed to establish ifthe apparently high rates of mortality could beruled out because of errors in coding or dataquality issues, or whether concerns aboutquality of care remained.

In a number of the alerts, poor coding wasapparent. However, the range of alerts thatemerged for the trust started to suggest amore general problem with high mortality,rather than an issue isolated to one particulararea or specialty. We calculated that thechance of this number of alerts, within anindividual trust, all being false alarms wasextremely low (probability, p 0.001). Wetherefore considered data across the wholetrust, which showed that the raised mortalitywas a general concern for emergencyadmissions, but not for elective admissions(see the next section).

We also had concerns regarding the trust’sresponses when we wrote to follow up thesealerts. In comparison to other trusts,responses received from the trust did notcontain enough detail of the investigations oranalysis carried out, yet the trust assured usthat the alerts were as a result of problemswith coding rather than clinical care.

The trust purchased Dr Foster’s real-timemonitoring system in early 2006, and used thisfor its internal surveillance of mortality (see

appendix E). The trust gave us informationgenerated using this system for non-electiveadmissions for the financial year 2007/08. Thisshowed that the trust had significantly highmortality in 10 ‘patient groups’, andsignificantly lower than expected mortalityoutcomes in four groups. Because of thedifferent alert thresholds used, false alarmswould be more frequent under this systemthan under the monitoring tools used by theHealthcare Commission or, centrally, by theDr Foster Research Unit. However, thelikelihood of this many alerts within a singletrust being false alarms is very small (p 0.001).

Standardised in-hospital mortality rates foremergency admissions

We compared the trust’s in-hospital mortalityagainst mortality in other non-specialist acutetrusts in England. We focused on patientsadmitted as emergencies who were aged 18and over. Patients admitted as emergenciesaccount for more than a third of alladmissions to acute hospitals.

We adjusted (or ‘standardised’) the figures fora number of factors – including the age andsex of patients and their diagnoses andprocedures (by Healthcare Resource Group,see box opposite) – so that we could comparethe trust with the national picture.

If a trust had outcomes that were the same aswould be expected in other non-specialisttrusts (once they had been adjusted asmentioned above), its standardised mortalityratio (SMR) would be 100. (Note that SMR is adifferent measure to Dr Foster’s hospitalstandardised mortality ratio (HSMR)). A scoreabove 100 indicates higher than expectedmortality. A score below 100 indicates lowerthan expected mortality.

Figure 1 shows the quarterly SMRs foremergency admissions to the trust of peopleaged 18 and over between April 2003 andMarch 2008. This is compared to the expectedSMR of 100. It can be seen that the trust’sSMR was consistently higher than expectedover a five-year period.

v

v

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23Investigation into Mid Staffordshire NHS Foundation Trust

Looking at the three financial years coveredby the investigation, we then conducted astatistical analysis of the SMRs to examine towhat extent they could have been due torandom variation. This analysis also allowedfor the presence of other factors, unrelated toquality of care, such as deprivation orethnicity. We concluded that, for the threeyears we examined, there was a less that 5%probability that the high mortality rates at thetrust for patients admitted as emergenciesaged 18 or over were due to chance. In otherwords, the rates were ‘significantly high’ (seestatistical appendix E for more details).

Elective admissions

We carried out equivalent analysis ofstandardised mortality ratios to examinemortality outcomes for elective admissions atthe trust. This analysis did not indicate anyconcerns about higher than expected mortality(see table 7 in appendix E for more details).

For each episode of hospital care, there willbe a primary diagnosis recording the mainreason why the patient is in hospital and,often, a series of secondary diagnoses thatmay be relevant to the episode of care. Anyprocedures that were undertaken will alsobe recorded against that episode. Thecombination of diagnoses and procedures isthen mapped to a Healthcare ResourceGroup (HRG) for that episode. HRGs grouptogether cases that are clinically similar andrequire similar levels of resource fortreatment and care. These groupings areoften referred to as ‘case mix’.

Individual HRG codes are grouped into HRGchapters. Each chapter describes the HRGsfor one or more body system.

Healthcare Resource Groups

Source: Hospital Episode Statistics

180

160

140

120

100

80

60

40

20

003/04 03/04 03/04 03/04 04/05 04/05 04/05 04/05 05/06 05/06 05/06 05/06 06/07 06/07 06/07 06/07 07/08 07/08 07/08 07/08

Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4

Financial year and quarter

SMR

Mid Staffordshire

SMR = 100

Figure 1: Quarterly standardised in-hospital mortality ratio (SMR) for Mid StaffordshireNHS Foundation Trust (emergency admissions aged 18 and over), 2003/04-2007/08

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Non-standardised in-hospital mortality ratiosfor emergency admissions

Non-standardised or ‘crude’ mortality ratioswere examined in a similar way, comparing in-hospital mortality after an emergencyadmission among non-specialist acute trusts inEngland. This is a useful additional measure, asit removes any potential effects of differences inthe accuracy of clinical coding across trusts.

Analysis of the trust’s non-standardisedmortality ratios has shown them to besignificantly high, at the 5% level (p 0.05), for allthree financial years covered by theinvestigation (see appendix E for more details).

Standardised HRG chapter level in-hospitalmortality for emergency admissions

Having established that mortality wassignificantly higher than expected in overallemergency admissions for those aged 18 andover, analysis was carried out to determinewhether this was concentrated in specificHRG chapters. The comparison was againstother non-specialist acute trusts and case mixfactors standardised for included yearquarter, age, sex and admission HRG.Standardised mortality was found to besignificantly high, at the 5% level (p 0.05),across a range of HRG chapters.

This analysis suggests that the higher thanexpected mortality that we had observed atthe trust was spread across a number ofdifferent groups of patients admitted asemergencies. Rather than being able topinpoint one clinical area causing higher thanexpected mortality, these findings wereindicative of systemic problems across thetrust’s emergency care system (see appendixE for more details).

Standardised HRG chapter level ONS-linkedtotal 30-day mortality

By linking HES records with mortality datarecorded by the Office for National Statistics(ONS), it is possible to get a measure ofmortality within 30 days of admission tohospital, regardless of whether the patient

died in hospital or after discharge. Theanalysis of total 30-day mortality is a usefulcomparison to in-hospital mortality. Forexample, if a trust had particular problemswith being able to discharge patients due to alack of care provision in the community, thentheir in-hospital mortality may look higher,whereas their overall 30-day mortality couldbe similar to other trusts. Conversely, a trustthat routinely discharges patients earlier thanothers may have favourable in-hospitalmortality rates, but higher than expected total30-day mortality rates.

ONS-linked HES is currently only availableuntil the end of 2006/07. The analysissuggests, as was seen with in-hospitalmortality chapter level analysis, that therewas high mortality within 30 days and it wasspread across a range of groups of patients(see appendix E for more details).

v

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25Investigation into Mid Staffordshire NHS Foundation Trust

Findings of fact on the trust’s mortality rates

• During the period July 2007 to March2008, Dr Foster generated four mortalityoutlier alerts for the trust, and a furtherthree were generated through thesurveillance of mortality outliers at theHealthcare Commission. Four morealerts (two by Dr Foster and two by theHealthcare Commission) were generatedbetween the launch of the investigationand November 2008.

• The response of the trust to ourinformation requests about the outliers didnot contain enough detail to support theclaim that the alerts were due to codingissues and not problems with quality ofcare.

• Analysis of Hospital Episode Statisticsshowed that the trust had significantlyhigher than expected standardisedmortality for patients aged 18 and overwho were admitted as emergencies. Thiswas the case for all three financial yearscovered by the investigation.

• Standardised mortality ratios for electiveadmissions did not indicate any concerns.

• Crude mortality rates for patients aged18 and over who were admitted asemergencies had been persistentlyhigher than the national rates for non-specialist acute trusts over the periodcovered by the investigation.

• The higher than expected standardisedmortality ratios at the trust were spreadacross a range of Healthcare ResourceGroup chapters, rather than beingconcentrated in a few groups of patients,suggesting that there were systemicproblems with the trust’s emergency caresystem.

• ONS-linked 30-day mortality analysisshowed that mortality was higher thanexpected within 30 days and was spreadacross a range of conditions.

Summary

In summary, this analysis of statistics showedus that mortality rates were higher thanexpected in this trust, both for in-hospitaldeaths following an emergency admission andin relation to specific procedures, diagnosesand Healthcare Resource Groups across thepathway of emergency care. We decided that itwas important on behalf of patients to seek tounderstand these unexplained, andconsistently higher, outcomes.

We therefore contacted the trust to explore thereasons. The trust took the view that thevariation was due to how procedures werecoded – that is, how they were recorded andthereafter how this record was used as thebasis for analysis. The trust’s explanation didnot satisfy our concerns, and we thereforelaunched this investigation.

We were particularly concerned because ofthe extent to which the mortality rates werehigher than the norm for the whole of the fiveyear period from 2003 to 2008. These statisticshighlight differences from the norm, and theywere a trigger for our investigation. They donot of themselves provide any explanation forthese differences.

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The trust’s arrangements for the collection,reporting, analysis and use of clinical data

Sources of evidence

• Interviews with staff past and present

• Report by CHKS (Casp HealthcareKnowledge Systems) on recoding of clinicalactivity at the trust

• Report by the Audit Commission

• Trust documents, including minutes of themortality outcomes group

BackgroundWe were told by clinical staff and managersthat the trust had a long history of poor qualityinformation about its services. This was alsoone of the findings of the clinical governancereview in 2002.

A report by CHKS was commissioned by thetrust in early 2007, due to concerns about thecoding of clinical data. The report identifieddeficiencies in the clinical coding entered inthe Patient Information Management System(PIMS). This was manifested by inaccuraciesin coding and under-reporting of co-morbidities (that is, patients’ other healthproblems). The coding manager at the timehad been on long-term sick leave and the restof the team were working part-time. Contactwith clinicians was also poor, with codersbeing reluctant to approach them aboutunclear notes. Clinicians had littleunderstanding of the need to make notesclear for the coders.

The trust recruited a new coding manager inJuly 2007, when the previous post holderretired. More investment was put into thedepartment and new members recruited tothe team. Staff told us that the new codingmanager had had a positive impact on thequality of coding. The new manager built

better relationships with clinicians andmotivated her staff to attend training coursesand gain accreditation. Examples of positivedevelopments included having consultants onthe clinical coding and data quality group, andsystems that the coders could use to cross-check information, such as radiology andpharmacy reports.

An external audit of clinical coding,undertaken in early 2008 by accredited clinicalcoding auditors, reviewed 300 ‘finishedconsultant episodes’. This was part of theAudit Commission’s national data assuranceframework in 2007/08 for payment by results.Payment by results is the system for fundingthe ‘case mix’ used to reimburse providers ofacute hospital services for the majority oftheir activity. Case mix refers to the fact thatthe price paid is related not only to the volumeof activity but also to the type and severity ofthe illness or injury being treated.

The auditors extracted all the relevantdiagnostic and procedural information fromthe case notes and assigned the appropriatecodes for a sample of 300 episodes of carethat occurred between 1 July and 30September 2007. The areas audited weretrauma and orthopaedics, ear nose andthroat, ophthalmology and paediatrics. In all,only 71.7% of primary diagnoses and 59.9% ofsecondary diagnoses were found to have beencoded accurately. This meant that the trustwas in the worst quarter for accurate codingof diagnoses. The accuracy of coding ofprocedures was also audited: 83.1% ofprimary and 84.3% of secondary procedureswere correct. Overall, the audit found that 7%of episodes would have changed HealthcareResource Group had the clinical coding beencorrect. This was lower than the nationalfigure of 9.4%.

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27Investigation into Mid Staffordshire NHS Foundation Trust

The coding manager told us that she still hadconcerns about some of the clinical input tocoding. It was reported that junior doctorscould present a problem because of theirfrequent job rotations. They were oftenimprecise about diagnoses, whereas the mainproblem encountered with senior consultantswas the tendency to under-report co-morbidities.

With regard to other systems, we found thatthe log of activity in theatres had been badlymaintained. The trust supplied the completeoutput of its theatre log system for the periodApril 2005 to June 2008. However, there weregaps when the log was compared toinformation the trust had submitted toHospital Episode Statistics (HES). Forexample, of 13 procedures relating to therepair of abdominal aortic aneurysm thatappeared in HES, only four could be found inthe theatre log.

There were additional problems with matchinginformation between systems, caused by theinsufficient quality of the information toidentify individual patients. This informationwas largely taken from the trust’s previous‘korner card’ surgical log system, which was amanual system used generally in the NHS. Thetrust had updated to an electronic system forcollecting data from theatre in June 2008. Thisshould have been more effective in linking thetheatre records to the trust’s central patientmanagement system. However, there wereteething problems with this system.

The trust had recognised that internalmonitoring of outcomes had not beeneffective. There was also evidence of cliniciansnot wanting to be involved with monitoring.For example, in the summer of 2007, a systemwas introduced to enable clinicians to monitortheir own performance. Despite a trainingprogramme, the system was hardly used.

The trust had a history of poor performance onmortality. The data from Dr Foster showed thatthe three-year HSMR for 2003-2006 was 125.This was the fourth highest ratio in England.The trust had only begun to monitor clinicaloutcomes after the publication of Dr Foster’s

Hospital Guide in 2007, and had relied on theuse of the Dr Foster ‘real-time monitoringtool’ to identify areas of concern (‘red bells’).This tool was used by the trust’s lead clinicianfor clinical governance.

In response to its apparently high mortalityrate identified by Dr Foster, the trust initiallyfocused on the poor quality of the clinicalcoding of the cases involved. It alsoestablished a group to consider mortalityoutcomes. The group’s follow-up of highmortality rates had focused on reviews ofindividual case notes of patients who had died.This was conducted by clinicians at the trustover a period of time. The general conclusionsof the follow-up were that the deaths werepredictable and that no problems with carewere identified. In the next chapter and later inthe report, we consider some examples of this.

The trust’s responses to alerts abouthigh mortalityIn July 2007, the trust received a letter aboutan alert from the Dr Foster Research Unit,copied to the Healthcare Commission. Thisinvolved mortality for operations on thejejunum, a part of the small intestine. Wewrote to the trust in August 2007. The chiefexecutive replied in early September to saythat the trust was reviewing this alert duringSeptember and would be happy to supply acopy of its full report once complete. Wereplied and confirmed we would require acopy. On 25 October, we sent another letter tothe trust, requesting a copy of the report thathad not been sent by the trust.

The trust gave a copy of the review they hadundertaken to our local team in November2007, and we were subsequently provided withthe notes of the trust’s review of four sets ofcase notes.

The Dr Foster Research Unit sent anotherletter to the trust in August 2007 about afurther alert that had signalled on theirsystem, this time regarding aortic, peripheraland visceral artery aneurysms. This wascopied to the Healthcare Commission and was

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considered by our panel on mortality outliersin September 2007. On 10 October 2007, wesent a letter to the trust asking forinformation regarding this alert. No responsewas received from the trust in relation to it.

Further alerts were generated internally bythe Commission during the autumn of 2007,as part of the programme to identify andfollow up concerns about mortality rates.Given the unprecedented number of alerts, adecision was made by the mortality outlierpanel to pass all matters that it was aware ofregarding the trust to our investigations team,who considered them as an initialconsideration before launching thisinvestigation.

As part of the initial consideration process, wevisited the trust in March 2008. In aninterview, the chief executive apologised fornot responding directly to the letters aboutthe alerts described above. In a presentationgiven by the trust during this visit, the trustshared an action plan titled “Patient care andsafety action plan”. The first section of thisrelated to “mortality data” and the first ofthree actions was “engagement with HCCcentral team on any Dr Foster Alerts”. Sincethat time, and the start of the investigation,there have been two further Dr Foster alerts,in July and November 2008. The trust sent usa copy of its response to Dr Foster but did notdirectly contact the investigation team at theHealthcare Commission about these.

.

• The trust had a history of poor qualitydata, noted in the clinical governancereview in 2002. A report by CHKS in early2007 identified deficiencies in the clinicalcoding.

• The quality of coding had improved, butthere were still concerns about some ofthe clinical input to coding.

• The trust had very poor information aboutactivity in theatres, and this could not bematched with other sources ofinformation.

• The trust had little focus on outcomesbefore the publication by Dr Foster of thehigh hospital standardised mortality ratioin 2007.

• The trust considered that poor coding wasa likely explanation for the high hospitalstandardised mortality ratio.

• The trust established a mortalityoutcomes group, which worked mainlythrough reviewing case notes of patientswho died.

• The trust made a limited response toconcerns about mortality raised by theHealthcare Commission.

Findings of fact on the trust’sarrangements for the collection,reporting, analysis and use of clinical data

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Quality of care at the trust

Having looked at statistical outcomes forpatients in terms of mortality, in this sectionwe consider our analysis of case notes, theviews of patients, relatives and staff, andcomplaints received by the trust.

Healthcare Commission's analysis ofcase notesWe decided to look at the case notes of someof the patients who died, to provideinformation on the quality of care given tothese patients. We also wanted to seewhether the trust had systems to identifyshortcomings in care and cases that neededextra consideration, in order that lessonscould be learned. These reviews wereundertaken by our expert clinical advisers.

We looked at three main categories of casenotes. These were the notes of:

• 10 patients who had died having suffered astroke in the summer of 2007.

• 8 patients who died in October 2007 andwhose cases had already been reviewed bythe trust.

• 11 patients who died in A&E in the summerof 2008.

We also reviewed a number of individual casesdrawn to our attention, for example fromreports of inquests.

Patients with acute cerebro-vascular disease(stroke)

We looked at the notes for 10 patients whodied during July and August 2007. All thesepatients had suffered a stroke, but this hadnot necessarily been the cause of their death.Our review looked at the quality ofassessment, diagnosis and management for

these patients using accepted standards fromthe National Sentinel Stroke Audit and theNational Confidential Enquiry into PatientOutcomes and Deaths.

For patients who were in hospital for severaldays, it was clear that fluid charts andsummaries of fluid input and output werepoorly completed. Even when patients werereceiving intravenous or naso-gastric fluidsand had a urinary catheter in place, thesecharts were often incomplete. Transfers fromA&E to wards and between wards were alsopoorly documented in the records, often withno clear handovers recorded in either medicalor nursing records.

Based on the clinical records for the 10patients, our experts considered that fivedeaths were predictable, in other words to beexpected. In these cases, CT scans wereproperly performed and findings immediatelynoted. 'Do not resuscitate' orders wereappropriately discussed with families in thelight of these investigations, and this led tothoughtful and considerate care of patients inthe last few days or hours of their life.

Of the other five patients, one patient who wasrecovering from a stroke developed rectalbleeding and died. Although the right peopleseemed to have been involved in the care ofthis patient, the patient’s conditiondeteriorated without a clear set of decisionsbeing documented.

A second patient suffered a brainhaemorrhage while being treated with twoanti-thrombotic drugs for ischaemic heartdisease (that is, disease of the coronaryarteries). Anti-thrombotic drugs reduce thechance of a clot (or thrombus) forming. Theymake it more likely that patients will bleed if ablood vessel becomes damaged. The

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consultant concerned wrote to the GP and tothe cardiologist who had prescribed the twoanti-thrombotic drugs. The consultant askedif giving these drugs together increased therisk of stroke and whether this was anappropriate combination. No answer to theseletters was available in the clinical record.

A third patient with a past history of strokedisease was admitted with a massivepulmonary embolism, which was correctlydiagnosed and treated. A couple of days afterthrombolysis (that is, ‘clot-busting’ drugtreatment) was given for the pulmonaryembolus, the patient suffered a stroke. Thedeath certificate mentioned the pulmonaryembolus but not the stroke.

A fourth patient came in on a Saturday withabdominal pain. Because the patient also hadpains in their arms and changes on theirelectrocardiogram (ECG or heart tracing), theywere given thrombolysis for a suspected heartattack. The patient rapidly developed signs ofa brain haemorrhage and died. It latertranspired that the changes on their ECG hadbeen caused by earlier damage to the heartand did not relate to this admission.

The fifth case involved a patient who had acoronary artery bypass graft (a type of heartsurgery) at another hospital and was thenadmitted two to three weeks later withgradual onset of weakness of the left arm and

face, typical of a stroke. The patient was notgiven any medication to prevent the formationof a clot in the deep veins of the leg. On thefourth day after admission, the patient had amassive pulmonary embolus and died.Although the patient's stroke care was welldocumented and satisfactory, it would havebeen worth discussing the arrangements inplace to consider treatment to avoid deep veinclotting and a subsequent pulmonaryembolus.

For these five patients, our expertsconsidered that they highlighted issues thatcould have provided opportunities to discuss,learn and improve. However, there was noindication that this had happened.

For example, the case of the third patientwould have been a good case to review,because of questions about the use ofthrombolysis and the risks that are attachedto it, and whether patients should be givenfollow-up treatment for blood clots when theyare known to have had a previous stroke.

Similarly, the case of the fourth patient wouldalso have been worthy of furthermultidisciplinary discussion, to consider themerits of waiting for the medical records anda second opinion from a more seniorphysician.

A pulmonary embolism happens when ablood clot or piece of a blood clot gets stuckin one of the blood vessels in the lungs. Theclot forms somewhere else in the body andis carried to the lungs in the bloodstream.

In 70% to 90% of people who get apulmonary embolism, the blood clot comesfrom one of the legs. The clot usually formsin one of the deep veins that run through thecentre of the leg. A blood clot in one of theseveins is called deep vein thrombosis, or DVTfor short.

Pulmonary embolism

• In half of the cases we reviewed, thediagnosis and care were appropriate. Inthe other cases, opportunities weremissed to review these and potentiallylearn lessons.

• Problems not identified included thearrangements to prevent deep veinthromboses and use of anti-thromboticdrugs.

• Fluid charts and summaries of fluid inputand output were poorly executed.

• Handovers were poorly recorded in thenotes.

Findings of fact from review of thestroke cases

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Patients whose care had been reviewed bythe trust's mortality group

Here we looked at a sample of the notes forpatients whose records had been reviewed bythe trust's group responsible for consideringmortality. The mortality group was establishedin August 2007 in response to concerns raisedby Dr Foster’s hospital standardised mortalityratio. The group’s purpose was described asbeing “to investigate deaths occurring withinthe trust by consultant review of case notes”.

The deaths that we considered occurred in atwo-week period in October 2007. Thespreadsheet that the trust provided followingthe review of deaths had information on age, abrief clinical summary, cause of death asstated on the death certificate, whether a postmortem had been performed, whether thedeath was thought to have been predictableand whether there were any “care issues”.The spreadsheet did not record achievementor otherwise of standards or good practice, forexample early assessment and regular reviewby a consultant. We asked to see originalforms that had been completed for individualcases but were told that these had not beenkept.

Of the 35 deaths in this period reviewed by thetrust, 34 were said to be predictable, that is, tobe expected, and one was judged to have been“unpredictable”. “Care issues” were listed infive of the cases and included the use of anti-coagulation (that is, drug treatment for bloodclots) and the procedure on surgical wards forensuring that patients who were not allowedto eat or drink still received their medication.Care issues were not identified by the trust forthe other 30 patients.

The primary purpose of our subsequentreview was to determine whether thejudgements made by the mortality groupabout the deaths being predictable werebased on accepted standards and werereasonable; whether they had identifiedshortcomings in the care and management ofpatients; and whether any actions, such asdeclaring critical incidents, should have beentriggered.

We reviewed eight sets of notes, which hadpreviously been subject to review by the trust’smortality group. We chose these eight becausethey were all patients admitted as emergenciesand were a reasonable spread of commonconditions. In seven of the cases, the trust hadrecorded the death as “predictable”. Our reviewof the notes suggested that only two of thedeaths were predictable, and there were someconcerns in all of the others.

In one case, there was a delay of three daysbefore the patient had an operation on theirfractured femur. Another patient developed C. difficile as a likely consequence of antibioticsprescribed in the hospital. We had concernsabout management both of fluids and nutritionfor this patient, and whether the patient wasgiven the correct supplementation of potassium.Despite these notes containing details of acomplaint by the relatives about nursing care,and specifically describing the patient havingspent four hours in a soiled bed before the bedwas changed, the trust's mortality group judgedthat there were no “care issues”.

Another seriously ill patient appeared to havehad their care managed entirely by juniordoctors in the middle of the night. The onlyinvolvement of a senior clinician was atelephone consultation. Although this deathmay well have been unavoidable, we wereconcerned about the process of makingdecisions and the seniority of doctors involved.In another case, the majority of reviews werecarried out by the most junior grade of traineedoctor, even when another healthcareprofessional had requested a medical review. Inthis set of notes, the ECG record of anotherpatient had mistakenly been filed.

In another case, nursing staff on severaloccasions documented high modified earlywarning scores (MEWS) in the period after anoperation. MEWS is a simple physiologicalscoring system that enables nurses to identifypotential deterioration in patients and respondappropriately. Many acute hospitals use theMEWS system to monitor the clinical progressof patients. It is particularly useful to identifypatients at risk of serious deterioration in abusy clinical area.

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High MEWS should have triggered a clinicalresponse, but there was no evidence of this.Our reviewers felt this case should have beenthe subject of a post mortem.

The trust outlined “care issues” in only threeof the cases, but we considered that therewere examples of substandard care in at leastone area in all eight cases. In four of these,the management of fluids appeared to bepoor, and in three, the management ofnutrition was poor. Families had complainedabout the standard of nursing in two cases,but the trust's review had not identified this.

Lack of review by a senior doctor was arecurrent theme, expressly evidenced in threecases in our analysis. In one patient whobecame seriously ill, there was no evidence ofany medical review for five days. This patienthad been prescribed a mixture of antibioticsthat may well have predisposed them to thedevelopment of C. difficile had they survived.Delays in care and lack of promptness inreview were mentioned in two other casesthat we considered.

Patients who died in A&E

We reviewed the casualty cards of 11 patientswho died in A&E in July and August 2008.

In some cases, the documentation was quitepoor. Most gave no cause for concern in termsof their clinical management, but there weresome concerns in a small number of cases.

For example, a patient bought to A&E justafter midnight with severe abdominal andback pain was not seen by an A&E middlegrade doctor for two hours. The recordssupplied do not show any evidence of initialassessment on arrival or of vital signs takenon arrival. The resident surgical officer sawthe patient four hours after arrival. Adiagnosis of abdominal aortic aneurysm (abulging caused by a weakened wall of theaorta as it passes through the abdomen) wasagreed and an initial management plan, toadmit the patient and review the followingmorning, was established. Before this couldhappen, the patient died from a rupturedaneurysm. Our reviewers thought that thisdeath may have been inevitable, but withoutappropriate records it is not possible to becertain. However, there are concerns aboutthe initial delay, lack of early assessment ormonitoring, and leaving a patient with a lifethreatening condition for four hours beforeany further attempt at diagnosis withscanning or surgical intervention.

In another case, we were worried that aconsultant gave an opinion to withholdtreatment, having relied on a junior doctor'sreport and without having actually seen andassessed the patient in person.

In early September 2008, there was a disputebetween doctors in A&E and the critical careunit about whether a patient should beventilated. We asked for this case to beinvestigated by the trust. The review foundthat the arrangements for involving criticalcare staff in the care of patients needed to bereviewed, with clarification that the lack of abed in critical care must not precludeinvolvement of the critical care team.

• The reviewers did not use criteria basedon standards to judge the quality of care.

• There were no obvious criteria fordesignating a death as being predictable.

• Instances of poor management of fluidbalance and nutritional status wereidentified by our reviewers but not by thetrust’s mortality group. Similarly, thetrust’s mortality group did not identify thefailure to use MEWS effectively or thefailure to obtain senior medical opinionearly.

• Lack of review by a senior doctor was afeature in several cases.

• Opportunities were missed to learnlessons from the deaths reviewed.

Findings of fact on these cases and thedecisions made by the mortality group

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33Investigation into Mid Staffordshire NHS Foundation Trust

Other cases that we reviewed

We also reviewed three patients who had beenoperated on for abdominal aortic aneurysms.Two of these patients were admitted aselective cases and one was an emergency.Repairing aortic aneurysms is major surgerywith a high mortality rate. We had someconcerns about the decision to operate in theelective cases, as the patients had high riskfactors such as severe obesity. In all thesecases, we noted the failure to identify post-operative complications, something that willbe considered later in the report. We werealso concerned that the case notes were ofpoor quality, and poorly assembled andorganised.

Nursing notes

A review of a range of nursing notes was alsoconducted. Generally, the nursing notes werepoorly organised. They were seldom inchronological order. There were often gaps incare plans, in fluid balance charts and in therecords of urine output. The time was notnoted when intravenous fluids werecommenced. The ‘Waterlow’ score for risk ofpressure damage (that is, pressure sores) wasoften added up incorrectly.

Inquests

We noted that there had been a number ofinquests where there had been complicationsof operations or missed diagnoses of seriousconditions.

A review of the medical notes of one casehighlighted that signs of deterioration in thepatient after the operation had been missed,and this had happened more than once in thesame case. The notes of the initial majoroperation were missing from the file and thenotes were generally poorly organised. Thetrust had not treated this as a seriousincident, the case had not been reviewed andlessons had not been learned.

The trust was able to provide us with someinformation about inquests. The trust’s reporton inquests contained summarised details of

51 deaths, of which 33 may have occurred on asurgical ward following surgery or aprocedure. Twelve involved complications froma fall, orthopaedic surgery (that is hip or kneereplacement) or fractured hip. Nine casesinvolved bowel surgery. Four cases mentionedthat the patient developed a venousthrombosis, clot or pulmonary embolism. Twoinquests involved complications fromabdominal aortic aneurysms.

The coroner told us that he was not worriedabout the number of inquests involving thetrust. He declined to provide us withinformation about the number of inquestsinvolving the trust and the verdicts over theperiod covered by the investigation. Themedical director told us that the coroner hadinformed her that the Stafford area did havemore inquests than his two other areas, but thecoroner did not have specific data. In a letter tothe medical director, he reported that herequested postmortems in 35% of all his cases,compared with the national average of 47%. Inthe cases reported to him, there was no inquestand no postmortem in 62% of cases, comparedwith a national average of 52%.

• There was a lack of timely review by asenior doctor in person in three of thedeaths in A&E.

• Nursing notes were generally poorlyorganised.

• There were more inquests involving thetrust than neighbouring trusts.

• The coroner declined to provide us withinformation about inquests involving thetrust.

Findings of fact

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Views of patients and families on thequality of care at the trust

Sources of evidence

• Healthcare Commission national inpatientand A&E surveys

• Interviews with patients and relatives

• Complaints

• Ipsos MORI survey of patients, visitors andcarers (May 2008)

National survey results

In the latest national survey available, theHealthcare Commission's survey of inpatientsin 2007, the trust was in the best 20% of trustsfor two questions out of 62. It was in the worst20% for 39 questions (63%). The likelihood ofthis being by chance was very low (p 0.001).

The trust was in the worst 20% for overallstandards of care and whether patients feltthey were treated with respect and dignity inthe hospital.

The trust was in the top 20% for “Were youoffered a choice of hospital for your firsthospital appointment?” This question appliesto patients admitted for elective operations,not as emergencies. It was also in the topgroup for “Did you have somewhere to keepyour personal belongings whilst on the ward?”

Some of the specific relevant questions inwhich the trust was in the worst 20% onresponses included:

• How long did you wait before beingadmitted to a bed on a ward?

• In your opinion, how clean was the hospitalroom or ward that you were in?

• Did you have confidence and trust in thedoctors treating you?

• In your opinion, were there enough nurseson duty to care for you in hospital?

• As far as you know, did nurses wash orclean their hands between touchingpatients?

• How much information about your conditionor treatment was given to you?

• Were you given enough privacy when beingexamined or treated?

• Did you think the hospital staff dideverything they could to help control yourpain?

• After you used the call button, how long didit usually take before you got help?

The trust's performance in the inpatient surveyin 2007 had deteriorated from the position in2006. Then, out of the 58 questions, the trustwas one of the worst performing 20% of trustsfor 13 questions (22%) and was one of the bestperforming 20% of trusts for seven items(12%). In the 2006 and 2007 surveys, the trusthad been in the worst 20% on the questionabout whether there were enough nurses. In2005, the trust performed better, being in theworst 20% for only three questions and in thebest for 10 questions. One of the questions in2005 on which the trust fared poorly was howlong it took patients to get help when they usedthe call button.

The trust commissioned a survey by IpsosMORI in May 2008. Unlike the national survey,this was carried out while patients were still inhospital through face-to-face interviews byindependent contractors. It consisted of fourquestions rather than 62. It found a high levelof overall satisfaction, with 94% of inpatientsrating care as excellent, good or fairly good.The corresponding figures for visitors andcarers were 88% and 93% respectively. Areport to the hospital management board inJune 2008 noted incorrectly that 99% ofinpatients and 95% of visitors felt that patientswere treated with respect and dignity.However, detailed results of the survey in thesame report showed that only 76% ofinpatients and 61% of visitors felt that patientswere treated with respect and dignity most ofthe time. These results were not benchmarkedagainst those of other trusts. The report alsomisquoted the results of the national NHSsurvey of inpatients for 2007.

v

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35Investigation into Mid Staffordshire NHS Foundation Trust

The results of the national survey ofemergency care were published in January2009. These related to care provided betweenJanuary and March 2008 and showed the trustto be in the worst 20% of trusts for how carewas rated overall. More details are included inthe chapter on A&E.

Comments from patients and relatives aboutgeneral aspects of care

We had an unprecedented response frompatients and relatives anxious to tell us aboutcare at the trust. Some of the people whocontacted us were members of a local group'Cure the NHS', established because ofconcerns about poor standards of care at thetrust. This group existed before theinvestigation was announced.

The cases we heard about nearly all involvedpatients admitted as emergencies. Theoverwhelming majority of the 103 relatives andpatients who contacted us were not happy withthe care received at the trust. These concernsoccurred in the three years underinvestigation. The main areas that gave rise toconcern were A&E, the emergencyassessment unit (EAU) and wards 6, 7, 10, 11and 12. Most, but not all, of the concernsrelated to older patients and to nursing care.

Some of the issues relating to nursing care onthe wards included allegations that staff failedto:

• Respond promptly to call bells, to assistpatients to go to the toilet or use acommode, or to help with personal hygiene.

• Respect the privacy and dignity of patients,and treat them with compassion.

• Give medication promptly andappropriately, and ensure it was taken.

• Help with feeding and drinking.

• Complete charts accurately.

• Pay attention to skin care, leading to bed sores.

Many attributed much of the poor care to theshortage of nurses. However, others talkedabout the poor attitude of some staff. They

described instances of nurses shouting atpatients, leaving them unattended for hoursand not providing a proper level of care. Somefelt that raising their worries led to noimprovement.

Although the cases brought to us by patientsand relatives occurred throughout the three-year period, we noticed clusters in the springof 2006 and the autumn of 2007.

On 7 July 2008, we wrote to the trust’s chiefexecutive, drawing his attention to theconcerns raised by patients and relatives, andasking that they be addressed. This letter isreproduced in appendix G.

Examples of concerns raised are also given inlater sections of the report, in relation toparticular clinical areas.

Views of the patient and publicinvolvement forum, and of staff, on thequality of care

Sources of evidence

• Statement from, and interview with, thechairman of the patient and publicinvolvement forum, and with a formermember

• Interviews with staff past and present

• Healthcare Commission’s NHS staff surveys

• Acute hospital portfolio review, 2004/05

• Formal review of complaints

The chairman of the patient and publicinvolvement forum told us that there had beena marked improvement at the trust since thecurrent chief executive had taken over,particularly in respect of cleanliness andhygiene, leading to an overall high standard ofperformance. One of the former members ofthe forum, however, considered that the forumhad not been sufficiently robust in scrutinisingstandards and that in 2006 the trust had notbeen open about the number of patientsinfected with C. difficile.

In the national survey of NHS staff in 2006, thetrust had a low response rate of 37%. The

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Many of the patients and relatives who contacted us were very concerned by poorcleanliness and hygiene at the trust. More than 30 drew these matters to our attention andothers confirmed they had concerns when asked directly. The following are some examples;there were many more. Further examples are given later in the report.

2005“While she was in here [EAU] for five days the chair next to her bed was covered in driedblood. This was not cleaned over the whole time she was there. Her husband also saw aninstrument being dropped on the floor and then put back on the tray. She felt that thecleaners just seemed to push dirt around rather than clean.”

2006“Cleaning was poor, and excrement trodden into the floor remained for several days.Curtains were hanging off their hooks. High surfaces, the window bars and the curtainswere dusty. The floors were given only a basic wiping. The cleaner missed some corners,including the toilet area.”

“He was sent to the accident & emergency department and there the toilet was filthy; it wascovered in blood and urine. I tried to clean up the floor of the toilet with a paper towel. Hewas then moved to the side room, which was not clean, with used alcohol wipes and the endof a previous infusion on the floor.”

2007“She had tried to take her mother to the toilet. It had been filthy and she had to clean itbefore her mother was able to use it. She explained that she had had to take off a dirty padand there was no bin to put it into. She had then taken it outside and tried to take it toanother bin, but this was overflowing. The hospital was often filthy with blood on the floors.In particular the PDU [the patient discharge unit] was filthy; the toilets and shower rooms inthere were filthy.”

“When he was admitted the place [A&E] was filthy; there was dried blood and rubbish on thefloor.”

“The ward, in hospital terms, was filthy. He described it as being nothing more than alaboratory for C. diff and MRSA cultures.”

“Faeces were often splashed on the bedside, armchair, and lockers. It was not cleaned up.During the whole time that their grandmother was in the hospital they felt the ward was onlycleaned about once or twice. They didn't seem to clean properly and missed huge areas.”

Views of patients and relatives who contacted us, on cleanliness and hygiene at the trust

trust featured as one of the worst 20% oftrusts in 14 areas (54%) and it featured as oneof the best 20% of trusts for one area (4%),with the remainder (42%) falling into theintermediate 60% of trusts.

The trust performed poorly on a questionabout whether staff would be happy, as apatient, with the standard of care at the trust –only 27% of staff agreed or strongly agreedwith this statement. Nationally, the figure was42%. Forty-seven per cent of staff disagreed

or strongly disagreed with the statement,compared with 25% nationally. The questionwas removed from the following year’s staffsurvey, so it is not possible to compare theposition in 2007.

We asked 80 members of staff whether theywould be happy to have a relative treated atthe trust. Overall, 41 (51%) said they would behappy.

Different groups responded differently. Thegreat majority of non-clinical staff would be

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37Investigation into Mid Staffordshire NHS Foundation Trust

happy: 13 of 16 non-clinical staff (81.3%) saidwould be happy for a relative to be treated atthe trust. However, the majority of doctorswould not be happy: 10 out of 26 doctors(38.5%) would be happy for a relative to betreated at the trust, but 16 (61.5%) would notbe happy. Nurses were in between, with 69%being happy for a relative to be treated. Morejunior doctors would be happy with a relativebeing admitted than would senior doctors.Staff in the surgical division were more likelyto be unhappy about a relative being treated atthe trust.

Many clinical staff told us of their concernsabout the quality of care at the trust and gavespecific examples. This is covered elsewherein the report.

Complaints

The acute hospital portfolio review in 2004/05showed the trust had a high overall numberand rate of complaints. The trust was worstout of five local trusts for the number ofcomplaints about nursing care per 10,000occupied bed days, and the second worst outof 24 small trusts outside London.

Our analysis of complaints received by thetrust during the period covered by theinvestigation showed that there wereconsistent concerns about standards ofnursing care.

This can be seen in the trust’s formal reviewof complaints for July to September 2005,where concern about basic nursing care wasin the top five of complaints. Just over a yearlater, the report on complaints to the trustboard for October to December 2006 againfound frequent complaints about basicstandards of nursing care (access to callbuzzers, delays in obtaining assistance anddelays in administrating medication). Thisfinding was repeated during 2007.

In the trust’s annual report on complaints for2006/07, the top five themes for clinical careincluded infection control, medication errorsand delays, the management of pain andpatients falling.

We undertook an analysis of 74 complaintsreceived by the trust between July andSeptember 2007, relating to the divisions ofsurgery and medicine. In 13 cases, there weremajor concerns related to basic standards ofnursing.

The trust’s report on complaints for the firstthree months of 2008 noted that complaintsabout two medical wards, wards 10 and 11,had been of some concern over recentmonths. These wards were averaging twocomplaints a month. The general themes werebasic standards of care.

• The trust fared poorly in the nationalinpatient survey, particularly for 2007where it was in the worst 20% of trusts for63% of questions. The trust was also ratedin the worst 20% for overall standard ofcare.

• Almost all of the 103 patients andrelatives who contacted us weredissatisfied with the quality of care,particularly nursing care. Many were alsoconcerned about poor hygiene and thelack of cleanliness.

• In the 2006 national staff survey, 27% ofstaff said they would be happy with thestandard of care at the trust. Thiscompared to 42% nationally. The resultwas in the worst 20% of trusts.

• Of staff we interviewed, half said theywould be happy for a relative to be treatedat the trust. The proportion varied from81% of non-clinical staff to 38.5% ofdoctors.

• In 2004/05, the trust was the second worstout of 24 small acute trusts outsideLondon for the number of complaintsabout nursing, per 10,000 occupied beddays.

• Complaints received by the trustsuggested longstanding concerns aboutthe quality of nursing care.

Findings of fact on patients’ andstaff’s views of services

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Investigation into Mid Staffordshire NHS Foundation Trust38

Emergency care pathway

The emergency care pathway is a term used todescribe the route or path in the trust that apatient admitted as an emergency would beexpected to follow in an acute hospital. Itusually starts when the patient arrives at theaccident and emergency department. The nextstage is often an emergency assessment ormedical assessment unit, but could be aspecialist unit such as critical care orcoronary care. From an assessment unit, apatient might go home, transfer to a ward orspecialist unit, or be taken to theatre.

Since the trust had high mortality rates forpatients admitted as emergencies, theinvestigation team reviewed the major clinicalareas involved in dealing with suchemergencies and, as part of this, consideredthe emergency care pathway.

Accident and emergency department

Sources of evidence

• Interviews with staff past and present

• Interviews with patients and relatives

• Healthcare Commission’s national inpatientsurveys

• Observations carried out by members ofthe investigation team

• Observations by South StaffordshirePrimary Care Trust during an unannouncedvisit

• Complaints

• Trust documents, including review of A&E,analysis of complaints, minutes ofmeetings and operational policies

• Review by the Heart of England NHSFoundation Trust

• Guidance from NICE, NCEPOD, the Collegeof Emergency Medicine, the Royal Collegeof Physicians, and the Royal College ofAnaesthetists

• The trust’s website

• Department of Health statistics

• Healthcare Commission’s review of urgentand emergency care services

An accident and emergency (A&E) departmentis the front line of emergency care. The publichave expectations of an emergencydepartment that include rapid access to careand timely investigations and treatment.

The A&E department in the trust had beenmoved from one administrative division toanother. In 2005, it was part of 'patient access'and then it was transferred to the clinicalstandards directorate. Since April 2006, thedepartment has been part of the medicaldivision.

There were 66,571 total attendances at A&E atthe trust in 2007/08, according to the quarterlymonitoring data set collected by theDepartment of Health. In line with nationaltrends, there had been a slight but consistentincrease over the past three years, with anaverage daily attendance of around 180people.

The A&E department at Stafford Hospitalprovides most types of urgent and emergencycare. It receives patients brought in byambulance, patients referred directly by theirGP, and people who decide to go straightthere themselves. There are limitedalternatives in the local area for people whoneed emergency medical attention. There is anurse-led minor injuries unit at CannockChase Hospital in Cannock (about 10 milesfrom Stafford Hospital), an A&E department at

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39Investigation into Mid Staffordshire NHS Foundation Trust

the University Hospital of North Staffordshirein Stoke (about 14 miles) and a walk-in clinicat Haywood Hospital in Stoke.

For historical reasons, the trust did not receivemany patients with severe trauma, followingthe creation of trauma centres in the 1980s.Thus, patients who had suffered major traumawere usually taken by the ambulance serviceto other hospitals in the region, for examplethe University Hospital of North Staffordshirein Stoke or Selly Oak Hospital in Birmingham(about 33 miles from Stafford Hospital).Occasionally the trust received patients withmultiple injuries when the ambulance crew didnot realise the extent of the patient's injuries,or took a decision that it was in the patient’sinterests to take them to the trust. The trustdid not have the capability to cope withpatients with multiple trauma, since it lackedneurological and major trauma units, and didnot have a trauma team.

In 2006, the trust decided to send to A&E allpatients referred by GPs for admission, ratherthan admitting these patients directly to theemergency assessment unit.

Action taken by the Healthcare Commissionduring the investigation

During our visit to the A&E department in May2008, we became very concerned about theway the service was operating and the riskthat this represented to patients.

It is our practice to raise any such issuesimmediately, rather than waiting for thecompletion of the investigation. We asked foran urgent meeting with the chief executive toraise our concerns and we followed this up 24hours later with a letter, requiring urgentaction. This letter is reproduced in appendix F.

The details of our concerns are covered in thischapter. They included the low staffing levels,lack of leadership, no effective triage, lack ofmonitoring of one clinical area, lack ofequipment and poor training. We consideredthat the lack of supervision and senior coverfor both doctors and nurses was a risk topatients.

The trust took immediate action to addressthese concerns. One of the actions was tocommission a specialist team from the Heartof England NHS Foundation Trust to undertakean urgent review. The findings of this revieware also cited in this section.

By September 2008, the trust had made goodprogress in making improvements and we setthis out in a statement on our website on 25September.

The progress made in A&E is outlined later inthis report, in the chapter “Developments atthe trust since the start of the investigation”.

Patients' views on the A&E department

In the national inpatients survey in 2007, someof the specific questions in which the trust wasin the worst 20% on responses included:

• How much information about your conditiondid you get in the emergency department?

• Were you given enough privacy when beingexamined in the emergency department?

• How long did you wait before beingadmitted to a bed on a ward?

We have included comments made by patientsand relatives in the relevant sections below.

In January 2009, we published the results ofthe national survey of emergency care. Thiswas based on the views of patients who visitedA&E departments in England between Januaryand March 2008. The trust was in theintermediate 60% of trusts for 22 questionsand in the worst 20% for 11 questions. It wasnot in the best 20% for any of the questionsand was in the worst group for how care wasrated overall. The trust was rated among theworst 20% of trusts for the four questionsrelating to waiting times and for the questionsrelating to the cleanliness of the departmentas a whole, the relief of pain, and confidencein the doctors and nurses.

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The environment and the refurbishment of A&E

In March 2007, the trust began arefurbishment of the department to improvefacilities for patients. It took eight months,cost over £800,000 and was undertaken whilethe trust continued to provide the A&E service.The majority of staff reported that they had hadlittle opportunity to influence the changes. Thetrust told us that the main objective was toupgrade mechanical and engineering facilitiesin the department. However, the project briefin August 2006 described the objectives interms of an improved “patient journey” andimproved “patient observation”. The brief notedthat the changes would lead to an improvedexperience for patients, new models of careand better multidisciplinary standards of care.

An assessment of the workplace in A&E thattook place in May 2007 was reported to thegovernance meeting of the trust’s medicaldivision the following month. The assessmentidentified risks that included maintaining asafe and secure area, and outlined actions toreduce these. In August 2007, the section onperformance in the minutes of the trust'sboard described how the work was affectingthe ability of staff to work flexibly, which in turnwas having an adverse effect on theachievement of targets.

In September 2007, the members of thegovernance committee for the medical divisiondiscussed a series of incidents involving A&E.They acknowledged that the department was ahigh-risk area.

There was an increase in complaints duringthe period of refurbishment. As a proportion oftotal complaints at the trust, those about A&Erose from 32% to 42%.

As part of the investigation, the trust wasasked to provide details of any seriousuntoward incidents that had happened in thedepartment since April 2005. Many of theseincidents (54%) occurred during the months ofthe refurbishment.

The refurbishment was complete by December2007. There was a general view among most

staff we interviewed that the refurbishmentmade the department cleaner and brighter, butthat it had not helped the management ofpatients in A&E. The trust explained that therefurbishment was an upgrade, not a newbuild, and so there were limitations as to whatcould be achieved.

We visited the department several timesduring 2008 and interviewed many A&E staff.We noted difficulties with the layout of thedepartment. In particular, it was hard for staffto see what was happening to patients indifferent areas.

It was apparent that patients could not easilybe observed or monitored when they were inthe waiting room. There were two mainreasons for this. Firstly, the view from thereception desk was limited. This was aparticular concern, given that the receptionistswere relied on to observe the patients.Secondly, the view from the door that the staffused to enter the department was partlyblocked by an interior wall. This resulted in anumber of patients sitting around the corner,and therefore being out of sight.

Some staff also said that the layout made thedepartment difficult to manage, especiallyduring periods of increased activity. This wasdue to the physical separation of the differentareas of the department. For example the‘assess and treat’ area was out of sight of thenurses' whiteboard area and round a cornerfrom the main department. Likewise, it wasdifficult to monitor from the nurses'whiteboard the assessment cubicles forpatients with minor injuries, and impossible tosee how busy the cubicles were from otherareas of the department.

In the summer of 2008, a review of A&E wasundertaken by a team from the Heart ofEngland NHS Foundation Trust. This was atthe request of the trust's chief executive,following concerns raised by the HealthcareCommission. The review commented thatthere were poorly designed 'traffic flows' thatmade little sense to the staff. For example,patients requiring admission or x-ray had togo though the area for patients with more

Investigation into Mid Staffordshire NHS Foundation Trust40

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41Investigation into Mid Staffordshire NHS Foundation Trust

minor injuries and illnesses, adding tocongestion and reducing effective flow.

This review also noted that problems due togeographical separation were accentuated bythe lack of an IT system within thedepartment. It was impossible to determinehow busy one area of the department waswithout physically going there.

Equipment, and clinical and diagnostic services

The service provided by any emergencydepartment is dependent on the availability,accessibility and quality of a range ofequipment.

Many staff, including senior members of thedepartment, criticised the lack, and quality of,the equipment. We were told that this was alongstanding problem.

Examples provided by staff of equipment thatwas lacking in the A&E department includedtrolleys, working cardiac monitors in theresuscitation bays, sufficient lighting, portablesuction and tympanic thermometers (used toget a rapid and accurate assessment oftemperature).

The resuscitation bays were not properlyequipped. For example, there was only onedefibrillator for the four resuscitation trolleyswhen there should have been one for eachtrolley. This area was frequently used to itsmaximum capacity, emphasising theimportance of sufficient equipment. Guidelinesissued by the Royal College of Anaesthetistsspecify the need for each resuscitation bay tohave equipment capable of invasivemonitoring, such as monitoring the gases inarterial blood. This was not available.

The review by the Heart of England NHSFoundation Trust noted that basic equipmentin areas of the department appeared to betotally inadequate. The team was only able tolocate two fully functioning infusion pumps(stored in a linen room). Most of the staff thatwe interviewed reported a dangerously lowlevel of equipment for monitoring patientsthroughout the department, but mostimportantly in the areas where patients with

major illnesses or trauma were being treatedand in the resuscitation areas.

During our visits to the department betweenMay and October 2008, we were told thatequipment was on order, but much of it didnot materialise and the situation withequipment changed little.

Access to diagnostic equipment and servicesis also critically important to an emergencydepartment. Staff need 24-hour access to x-ray and computerised tomography (CT)scanning. The Royal College of Physiciansnoted in 2002 that the commitment of differentspecialties and services was essential inorganising effective working practices foremergency medicine. More specifically, theCollege of Emergency Medicine highlightedthat 24-hour access to CT scanning was anecessity for supporting an emergencydepartment.

A review by the National Confidential Enquiryinto Patient Outcomes and Deaths in 2007stated that hospitals that admit emergencypatients must have access to bothconventional radiology and CT scanning 24-hours a day, with immediate reporting.

The guidance from the National Institute forHealth and Clinical Excellence (NICE) on themanagement of head injuries suggested a CThead scan should replace a cranial x-ray andadmission with observation as the firstinvestigation. In March 2007, the hospitalmanagement board decided not to implementthis element of the guidelines. The trust'smedical director told us that they continued tocarry out a CT scan on any patient with a headinjury that was judged, after clinicalassessment, to require a scan. However,senior medical staff in A&E were concernedthat the guidance on scanning was notfollowed in full.

In April 2008, it was recorded on the medicalrisk register that CT scanning was onlyavailable between 9am and 5pm, Monday toFriday. Even when available, access to CTscanning was not straightforward, asrequesting a scan was only possible through aconsultant-to-consultant referral. We were

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told that the switchboard staff were notallowed to connect a call from middle gradedoctors to the consultant radiologist on call. Itwas raised in several interviews that, if therewas no consultant present to request a scan,this led to delays. This was reported to be acommon problem out of normal hours. Therelationships between the emergencydepartment and the radiology departmentwere reported not to be good. The trustprovided us with a protocol dated 23 May 2008,which stated that in exceptional circumstancesa middle grade doctor could call theconsultant radiologist directly to request a CTinvestigation. This was to be a temporaryarrangement.

We were given several examples of delays inobtaining CT scans, including one that involveda patient with a subarachnoid brainhaemorrhage.

Some staff told us that there were difficultiesin accessing emergency diagnostic ultrasoundout of normal hours, despite the fact that thisis also recommended in NICE guidelines.

Triage

Triage is a system to rapidly place patientsinto categories, according to the type oftreatment they need and how quickly theyneed it. It helps to prioritise patients who needurgent care. Triage can improve the safety ofpatients by reducing delays before morecomprehensive assessments. In some trustswhere patients are assessed by senior staffimmediately or after only a short delay, triageis no longer considered necessary.

Staff trained to perform triage should monitorand assess all the patients who come to theemergency department. Their role is toimmediately sort, direct, prioritise and informpatients, while also starting treatment (forexample, pain relief).

During the visits we made to the departmentbetween February and October 2008, there waslittle evidence of effective triage in operation.

It was unclear how long the trust had beenwithout effective triage, as there was no clearrecollection of the situation among the staffthat we spoke to. Some thought a triagesystem used to operate in the department anumber of years ago, but had faded out. Staffinterviewed during the visit in May 2008,including consultants, senior nurses, andmanagers, all reported that triage did nothappen mainly because there were too fewnurses available to do it.

The chief executive agreed in June 2008 thatthe lack of an effective system of triage wasunacceptable and was a "reflection of staffinglevels”. In July 2008, the person responsiblefor running triage, a senior advancedpractitioner, estimated that, for 80% of thetime, it was still not possible to triage patientsdue to the shortage of staff in the department.

The review by the Heart of England FoundationTrust found that there were few or noconsistent 'see and treat' methods in use inthe department, with little or no basic triage,provision of analgesia or simple x-rayreferrals, despite national guidance aroundthe benefits of these to reduce overall waits.

Investigation into Mid Staffordshire NHS Foundation Trust42

• The department had been refurbished in2007, improving its appearance.

• The layout of the department made itdifficult for staff to see patients in thewaiting room.

• The department lacked many items ofequipment, including sufficient numbersof working cardiac monitors inresuscitation bays and sufficient numbersof defibrillators.

• The trust did not implement performingCT scans as the first investigation inpatients with head injuries.

• Arranging CT scans out of normal hourswas not straightforward and sometimesled to delays in diagnosis.

Findings of fact on the environmentand equipment

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43Investigation into Mid Staffordshire NHS Foundation Trust

Receptionists were responsible for assessingany patients who did not arrive by ambulance.This was as a consequence of having too fewtrained nurses to maintain consistent triage.The receptionists were relied upon to assesspatients and categorise them as “major” or“minor”. They had to assess, oversee thepatients in the waiting room, and raise anyconcerns about a patient to the nursing staff. Ifa patient’s condition was deteriorating, it wasexpected that the receptionists would noticethis and alert a member of the nursing staff.

None of the reception staff were clinicallyqualified. The trust relied on administrativeworkers to perform a role usually filled byexperienced, specifically trained nurses. Asenior member of the departmentacknowledged that the dependency onreceptionists to perform triage wasunsatisfactory and unprofessional.

We were given examples by staff of instanceswhere patients had been adversely affected bythe lack of an effective system of triage. In onecase, a patient with known heart problemswas kept in the waiting room for 40 minutesbefore being assessed. Another patient with adislocated shoulder was in the waiting roomfor five hours before they were assessed andgiven pain relief. Two patients who came tosee us told us of two to three-hour waits inthe waiting room, although both weresubsequently found to have acute appendicitis.A senior doctor in training told us about apatient with an open fracture of the elbow whohad been sitting in A&E for over four hoursstill covered in blood, with no pain relief,observations, dressing or antibiotics.

Senior leadership

In April 2005, there were three permanent A&Econsultants in the department. In September2005, there was a consultant vacancy andattempts at recruitment were unsuccessful.The department relied on two consultants untilone left in March 2008. Cover from a locumconsultant started on 10 May 2008 and 15different locums were used between May andDecember 2008. The remaining consultantdescribed the department as isolated. He wasdescribed by many of his medical and nursingcolleagues as a poor leader.

There had been four managers of theemergency department between early 2006and late 2007. One of these was an interimappointment; another acknowledged to us thatthey personally were not suited to amanagement role. The head of division ofmedicine expressed the view that it had beendifficult to appoint a high-quality manager forA&E.

Medical staffing arrangements and cover

Guidance issued by the College of EmergencyMedicine recommends one whole-timeequivalent consultant to every 11,500 patients.The college states that a consultant should beinvolved in leading and managing emergencydepartments, including managing audit andclinical risk. Emergency departments areareas of high intensity, and therefore a seniorclinician's management and teachingworkload is likely to be greater than in manyspecialities

Due to the size of the trust's emergencydepartment and the number of patients whoattend, the College of Emergency Medicinerecommendation for the trust equated to aminimum of three consultants. This recentlyincreased to four. From September 2005 toMarch 2008, the department functioned withtwo consultants in emergency medicine, withthe support of another senior doctor, anassociate specialist, until October 2006. Therewas just one permanent A&E consultant formany months in 2008 and he was on own fortwo months. From May to December,

• There were too few nurses on duty toperform triage.

• A form of triage was carried out byadministrative staff in reception, despitethe fact that they did not have anyqualifications or training to do so.

• We were given examples of patients whohad been adversely affected by the lack ofeffective triage.

Findings of fact on triage

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25 bookings of 15 different locums providedintermittent support. In May, only two dayswere covered by a locum and in June, nine.

The trust's emergency care operational policystates that "the department shouldhave...senior medical cover on a 24-hour basisto ensure expert advice is available at alltimes". As a result of a redundancy of theassociate specialist in October 2006, it wasonly possible to have consultant cover for 12hours a day. This redundancy was part of theworkforce reduction at that time.

In September 2006, a paper to the hospitalmanagement board highlighted how the one intwo on-call rota, with the two consultantstaking turns to cover, was not tenable. A newrota was proposed that did not include on-callduties. This prompted concerns about how thetrust would respond to a major incident. Thesame paper was presented to the trust's boardin October 2006 and it was noted that seniorcover was sub-optimal in terms of hours. Thisissue was not mentioned again until theminutes of the hospital management board inDecember 2006, where concern was raisedthat the A&E consultants were no longerproviding 24-hour cover. They had agreed tocover a major incident. The hospitalmanagement group agreed that 24-hour coverwas necessary.

In the periods when the consultant was not inA&E and not on call, we were told that theclinical accountability for patients was notalways clear. There were periods when themost senior person in the department was adoctor who, although experienced, had nopostgraduate qualification in emergencymedicine.

Following difficulties in recruiting consultantsin emergency medicine, the trust took thedecision to reduce the effects of the shortageof consultants in the department by theappointment of consultants in acute medicine,also called acute physicians. In July 2006, itwas decided to divert the funding for an A&Econsultant to fund the appointment of an acutephysician. Acute physicians specialise in themanagement of the early stages of patientsadmitted as medical emergencies. They do not

have the same level of expertise for otherpatients, such as those admitted as surgicalemergencies or with traumatic injuries.

In the first instance, the trust appointed to thisrole an experienced senior doctor who hadheld a number of locum posts in the trust.

Acute physicians were responsible for theprovision of initial senior clinical advice, careand treatment for medical patients admittedto the trust, either through the emergencyassessment unit (EAU) or through A&E.Primarily, they had responsibility for medicalcare in the EAU.

The acute physicians were also expected toprovide senior cover in A&E and be part of theon-call arrangements. They provided somesupport for the care of medical patients, butwere less able to cover across the spectrum ofundifferentiated illness and trauma of A&Epatients. They were not trained or qualified todeal with the patients with surgical, traumaticor gynaecological problems who arrived at A&E.

Medical and nursing staff were concerned thatnot all the acute physicians were confidentabout, or prepared to deal with, medicalemergencies, let alone surgical patients.During interviews, staff provided us withexamples of acute physicians walking awayfrom patients or declining to help, if they werenot confident to deal with them. An examplegiven was a stroke patient with difficulty inbreathing who needed to have an endo-tracheal tube inserted. Another was a patientwith ventricular tachycardia, which is a lifethreatening abnormal rhythm of the heart.

The review by the Heart of England NHSFoundation Trust commented: “There was aclear deficit in trained emergency medicalnumbers, which has been recognised by thetrust. One trained and accredited consultant isobviously insufficient to provide the requiredlevel of senior cover in the department.Although there is a close working relationshipwith the acute medical physicians, this doesnot allow the department to be coveredappropriately 24/7. This is a significant riskand the department would not be sanctionednationally.”

Investigation into Mid Staffordshire NHS Foundation Trust44

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45Investigation into Mid Staffordshire NHS Foundation Trust

In September 2007, the trust's submission tothe Healthcare Commission's review of urgentand emergency care listed three permanentconsultants in emergency medicine. At thattime there were two such consultants. However,the trust included the acute physician.

Other medical cover: middle grades

Middle grade doctors in A&E are fairlyexperienced doctors who are sufficientlycompetent to be left as the senior doctor incharge of the department, particularly atnight, but with cover from a consultant fullytrained in the specialty. They can supervisejunior doctors under these conditions.Experienced permanent doctors should be inplace to staff the middle grade rota, but thetrust relied heavily on locum doctors. This isnot unusual in the NHS.

Throughout the period under investigation, thedepartment did not operate with therecommended number of middle gradedoctors. There should have been nine doctorsin this grade. A report on medical staffing inJuly 2006 showed there were two permanentwhole-time equivalent and 2.4 locum middlegrades. The submission to the HealthcareCommission's review of urgent care inSeptember 2007 listed three permanentmiddle grades, but did not give the number oflocums at the time.

In May 2008, we found the department had toofew middle grade doctors to provide anacceptable service. This problem waslongstanding. In September 2006, a paper tothe hospital management group describedproblems with the recruitment and retentionof middle grade doctors, resulting in theregular use of locums. It noted this was alsothe case nationally. The staffing arrangementswere reported to be a considerable risk.

The hospital management board agreed to atrial period for the first two weeks of October2006, where there would be no middle gradecover for the seven-hour period from midnightto 7am, Monday to Thursday. This was at thetime when there was no consultant cover forA&E after 9pm. At the end of the period, the

trust decided that this was unworkable andunsafe, and cover by mainly locum middlegrade doctors was reinstated.

Medical and nursing staff that we interviewedall reported that there were insufficient middlegrade doctors to provide adequate cover. Theyclaimed that the middle grade rota was notrobust, the hours were not compliant with theEuropean Working Time Directive and neitherthe middle grades nor junior doctors wereable to take sufficient breaks. One long-termlocum doctor only worked at night andsometimes worked a long sequence of morethan 10 consecutive nights.

The report produced by the Heart of EnglandFoundation Trust also noted that, due tostaffing levels at the time of their visits, assoon as there were two patients inresuscitation, the senior medical manpower ofthe department was effectively exhausted.

Training and supervision of junior doctors

In 2002, the Royal College of Physiciansoutlined that trainees need to have adequatetraining and experience to recognise criticallyill patients and make clinical decisions.Appropriate training included exposingtrainees to real clinical problems withsufficient mid-level and senior support. TheCollege of Emergency Medicine stated thatconsultants are expected to “supervise clinicalcare provided by others in the sameenvironment”.

A paper from the trust’s chief operating officerin April 2008 stated that “the main body ofmedical staff in the department consists ofrelatively inexperienced ‘foundation year two’(FY2) doctors and general practitionertrainees. These doctors require a high-level ofsupervision by senior staff, which can be verydifficult to achieve with just two emergencymedicine consultants in the department and asmall number of middle grade staff”. In fact,at this time there was only one consultant inemergency medicine.

From April 2008, there was only onepermanent consultant, virtually no educationand only limited supervision. The support from

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locum consultants amounted to 11 days intotal in May and June. A number of moresenior staff told us that opportunities to teachwithin the department were further limited bymanagers, or senior nurses, interruptingwhen a doctor was attempting to providetraining because of concerns over breaches ofwaiting times for patients.

Senior members of the department told usthat there was a “non-existent culture” withregards to education and training. Additionally,several interviewees specifically mentionedthat three-quarters of dedicated teachingsessions for junior doctors were cancelled,usually by managers on operational grounds.

On 25 June 2008, the dean of postgraduatemedicine wrote to the trust’s medical director.She expressed grave concerns regarding thetraining and supervision of the specialistregistrar trainee in A&E. The letter pointed outthat, if the training post had to be withdrawn,this would also have an effect on training formore junior staff such as foundation years oneand two, and vocational trainees. The letterasked for an action plan to show what middlegrade cover the trust would put in place, andfor assurance that consultant cover would beprovided during the day and evening shifts andthat a consultant would be readily available forrecall as necessary.

Overall staffing in A&E

We looked at other groups of staff as well asdoctors and senior clinicians. The majority ofstaff interviewed felt that the department wasoperating on too few staff.

We noted that staffing had been alongstanding problem for the A&E departmentat Stafford Hospital. Entries in a risk registerreport identified a number of problems withstaffing as far back as September 2002. Theseincluded a number of medical vacancies inA&E that were said to “affect the morale of thestaff which ultimately affects patient care andwaiting times”.

Investigation into Mid Staffordshire NHS Foundation Trust46

• There was a longstanding shortage ofconsultant medical cover.

• There was a longstanding lack of medicaland general leadership.

• The trust treated as interchangeable theroles of consultant acute physicians andconsultants in emergency care.

• The acute physicians were asked to coveraspects of A&E that were outside theirprofessional competence.

• There was a longstanding shortage ofmiddle grade doctors.

• For two weeks in October 2006, there wasno consultant or middle grade coverbetween midnight and 7am on weekdays.The trust decided that this was unsafe andreinstated middle grade cover.

• Inadequate supervision, training andsupport were given to junior doctors.

• The postgraduate dean wrote to the trustin June 2008 about inadequate supervisionfor doctors in training.

• There was little integrated multi-professional working in the department.

Findings of fact on leadership, medicalcover and supervision of junior doctors

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47Investigation into Mid Staffordshire NHS Foundation Trust

In April 2005, the medical division identified arisk that there would be too few staff tosupport the service, due to failing to replacestaff who terminated their employment. Thiswas recorded on the risk register, but noreview date was provided. In July 2005, it wasnoted that future demands of the service maynot be met due to insufficient levels of staff inthe department. From these entries, it isevident that staffing levels were considered tobe inadequate as far back as 2005.

Many staff that we interviewed told us thatthere were not enough porters, especially atnight. It was explained that the number ofporters had been reduced during the reductionof the overall workforce in 2006. When amember of the portering staff left they werenot replaced, and financial constraintsrestricted the use of bank and agency staff.Certain problems were highlighted as aconsequence of the reduced number ofporters, including delays in transfers ofpatients, increased waits for diagnostic scans,and limited security presence.

Nurse staffing

The operational policy for emergency carestated that the emergency department wouldhave cover by senior nurses on a 24-hourbasis, and that nurse staffing levels and skillmix would be driven by the needs of theservice. The review of skill mix by an externaladviser conducted in 2007/08 showed a gap instaffing of 17.4 whole-time equivalentsbetween the professional view of what theestablishment should be (54.9) and the actualfunded establishment (37.5).

Overall, the number of whole-time equivalentposts in nursing remained fairly constant from38.0 in January 2006 to 36.3 in September2007 and 37.9 in March 2008. The operationalpolicy stated that the department should havecover by a senior nurse all the time. However,there have been few senior nurses (bandseven) in the department in recent years.

In its submission to our review of urgent andemergency care services, the trust reportedthat it had seven band seven nurses. At that

time, there was only one band seven nurse inA&E. The trust had in error included theclinical site managers and other band sevennurses who were part of the trust’sestablishment at the time of the submission.

The review by the Heart of England FoundationTrust was critical of the level of nursingsupervision. The reviewers considered that thelack of band seven nurses was a considerablerisk that could result in poor standards ofcare.

The report said that, despite the recentappointments of a matron, a band eightadvanced practitioner, and a band seven post,there was still a worrying deficit of seniornurses. At the time of their visits, all but 2.5 ofthe nursing staff were band six or below.Because of some staff on maternity leave and2.5 whole-time equivalent nurses released tostaff the clinical decision unit, there wereapproximately 1,600 patients (in a year) forevery trained nurse.

The review added there was a lack of seniornursing leadership and the lack of band sevennurses was a significant risk that neededaddressing to prevent further episodes of pooror variable care. A number of band six nursesfelt underappreciated for the role theyundertook. An atmosphere of crisismanagement had developed and additionalsenior tier nurses were required to improvestandards.

There was concern among most A&E staff thatwe interviewed about the shortage of nursesin the department. The situation was referredto in interviews with A&E nurses as "abysmal"and "horrendous", with one intervieweestating the concerns over the low number ofnursing staff was the reason she was leavingthe department.

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Leadership, training and supervision of nurses

The review by the Heart of England NHSFoundation Trust in the summer of 2008 foundthat the nursing management team wasstruggling to cope with the situation in termsof consistently providing good quality care.This in part could be explained by lack ofpersonnel or the relatively high reliance onjunior grades of nurses. A number of band sixnurses emphasised their concerns about thecurrent lack of nursing leadership across allshifts. The nurse manager and deputy hadlimited clinical time or presence on a day-to-day basis, something “desperately needed toaddress concerns raised by staff aroundinadequate patient observations, monitoring,and delivery of minimum standards of care”.

The majority of clinical shifts were covered byband six nurses who had to undertake anumber of different roles at the same time.Through necessity, staff were taken from oneclinical area of the department to another,leaving a shortfall in the first area. This wasnot sustainable.

Nurses in an A&E department should be ableto perform skills such as taking blood,intravenous cannulation (inserting a hollowtube into a vein so that drugs and fluids canenter the bloodstream quickly) andelectrocardiograms. A senior nurse estimatedthat fewer than two-thirds of the nurses wouldbe able to undertake these tasks.

The recognised course offering specialisedA&E education is the English National BoardCourse 199 in A&E nursing. For those nursesat the trust who had received training, it wasgenerally training provided by the trust. Fewnurses had undertaken any nationallyrecognised course in A&E nursing.

The role of an emergency nurse practitioner(ENP) should be a standardised role,transferable from one hospital to another.However, most of the ENPs at the trust hadbeen trained in-house and were performingthe role with different levels of training. Thetraining was non-transferable. This meant

that, if a nurse working as an ENP at the trustwere to take up the role in another trust, theirtraining was unlikely to be accepted.

The trust's operational policy on emergencycare stated that the department would haveemergency nurse practitioners whose skillswould include advanced life skills, traumacare and paediatric life support.

We were told that there was no training planor department induction for new staff, andnewly qualified nurses were not routinelyprovided with clinical supervision. We weretold that the department lacked a seniornursing presence and that there was a lack ofnursing leadership.

The Heart of England NHS Foundation Trust’sreport noted that clinical supervision wasinadequate both from a medical and nursingperspective.

These matters were being addressed by thetrust and details are included in the progresssection of this report.

Investigation into Mid Staffordshire NHS Foundation Trust48

• Staffing problems in A&E had beenprevalent for a number of years.

• The number of nurses was low and therewere few band seven (senior) nurses.

• There had been little training anddevelopment of nurses.

• Leadership of nurses had been poor.

• The training for emergency nursepractitioners was provided in-house andwas not transferable if staff moved to othertrusts.

• The trust's submission to the review ofurgent care contained some inaccuracies:the trust declared there were seven bandseven nurses, but there was only one inA&E at that time.

Findings of fact on staffing, leadershipand training of nurses in A&E

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49Investigation into Mid Staffordshire NHS Foundation Trust

The focus on the target for patients to waitless than four hours

The four-hour waiting time target wasintroduced by the Department of Health in2004 as a minimum standard to ensure that98% of patients should be admitted,discharged or transferred within four hours ofarrival at an A&E department. The 2% cut-offrefers to the small number of patients whoneed to remain in the department for morethan four hours for clinical reasons or underobservation. An important element of A&Eperformance relates to achieving the four-hour waiting time target and trusts are judgedby their performance in respect of this.

The pressure on the department wasincreased in 2006 by the trust’s decision tosend all patients referred by GPs foradmission to A&E.

Staff generally supported the aim of thetarget, but were concerned that the trust’sfocus on it could distort priorities. Someconsidered that the shortage of beds in thetrust made it difficult to achieve, but that thetrust's managers held A&E staff responsiblefor any failures. Nurses told us they felt theywere in "the firing line" with regards tobreaches of the target and, as such, werealways being blamed. We heard about nursesleaving meetings in tears and beingthreatened that their jobs were at stake due tothe number of breaches. One nurse describedan average shift as "pressure, pressure,pressure".

Many staff that we interviewed volunteeredtheir view that the approach of the trust meantthat the care of patients had become secondaryto achieving targets and minimising breaches.Doctors considered that the prioritisation of thepatients with minor ailments led, on occasions,to a distortion of clinical priorities. Middlegrade doctors told us that they were asked towork with patients in the “minor” side to pushthese patients through, although this was at theexpense of more seriously ill or injuredpatients. They felt pressured to prioritisepatients who were close to breaching the targetrather than prioritise by clinical need.

Several doctors recounted occasions wherethey were asked by management to stoptreating more seriously ill patients in order tosee and treat patients with more minorailments. One example was given of when adoctor was asked to work in “minors”. At thetime the doctor was administeringthrombolysis to a patient who had suffered aheart attack. This doctor refused but wasworried that a more junior doctor might havefelt compelled to comply.

Both doctors and nurses told us that thepressure to meet the four-hour target forceddoctors in training to make rapid decisionseither to discharge or admit patients. In someinstances, they were discharged inappropriatelyand, in others, they were admitted but without aproper plan of care. This resulted in asubsequent delay, for example, in patientsreceiving fluids and antibiotics.

A senior doctor told us how a patient whoshould have gone to the critical care unit wasfirst sent to the emergency assessment unit toavoid breaching the target. Another said thatpatients with dislocated ankles were moved toinappropriate wards before having had X-rays,because they were going to breach the four-hour target. It could be hours after the injurybefore an x-ray was taken, by which time theankle was swollen and could even beulcerated. This was reported to be a frequentevent, rather than the exception.

We analysed the total time that patients spentin A&E, breaking it down into 10-minuteintervals. This was over the period from Aprilto December 2007. This showed there was amarked drive to admit, discharge or transferpatients in the last 10 minutes before the four-hour target was breached, as can be seen infigure 2.

Patients and relatives who came to see us toldus that there were several instances ofpatients who had been sent home from A&Ewho had to return soon afterwards and beadmitted. We therefore analysed data fromApril 2007 to March 2008 in respect of patientswho returned to A&E within seven days. Wefound 67 patients who re-attended the

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Investigation into Mid Staffordshire NHS Foundation Trust50

department within this time, 39 in the first sixmonths and 28 in the second. From these,there were 43 cases (25 in the first six moths)where the second attendance/admission foreach patient was for either the same or a verysimilar condition as the first. These casescould indicate instances where the patientmight have been discharged sooner thanappropriate.

In 25 cases (14 in the first six months), thesecond attendance/admission was for acondition related to, but that could beconsidered a deterioration or exacerbation of,the one causing the firstattendance/admission. These cases couldindicate instances where the patient mighthave been discharged inappropriately. Thesefindings cast some doubt on the trust’ssubmission to our review of urgent andemergency care in England, which reportedonly one unplanned follow-up attendancebetween April and September 2007.

In the private meeting of the board in March2007, it was noted that the results against thefour-hour target had been very poor in

February, and it would be impossible to meetthe target by the end of the year. An actionplan had been sent to the SHA and the aimwas to get as close to the target as possible.In April 2007, it was reported that the year-end performance had been met.

The clinical decision units

In 2005, the Department of Health outlined ina guide to emergency medicine that a clinicaldecision unit (CDU) should be supervised by aconsultant in emergency medicine. Patientsshould usually be admitted for no longer than12 to 24 hours.

The trust's policy for emergency care statedthat any patient who stayed overnight, or whowas admitted during the night to the CDU,must be reviewed by a senior member of theemergency department no later than 9am.The patients must either be discharged orreferred to a specialty team and, shouldreferral be appropriate, the patient must bemoved out of the unit to ensure that capacitywas available for that day. No patient shouldremain in the CDU for more than 12 hours.

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Figure 2: Distribution of patient numbers by total time in A&E, April-December 2007

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51Investigation into Mid Staffordshire NHS Foundation Trust

When we visited in May 2008, there were twoareas in the A&E department referred to asclinical decisions units. Both were locatedaway from the rest of the department. Thefirst area contained four beds and wasgenerally referred to as the “assess and treat”area or, more commonly and informally, as“small CDU”.

The second area contained 12 beds andopened in May 2008 when 12 beds wereremoved from the emergency assessmentunit. It was often called “big CDU”. We weretold that it had been opened suddenly, withouteither portable or wall suction working.Suction is necessary to clear secretions fromthe airways during resuscitation, for example.We learned that during the refurbishment theequipment attached to the wall had not beenproperly connected. An incident report had tobe filled out about this in order to have itremedied. The trust told us that portablesuction was available at this time, but later inthis report we note problems with itsavailability. The area of the larger CDU hadpreviously been used as a medicalassessment unit before being replaced by theemergency assessment unit in August 2004.

Many staff expressed negative views of theCDUs and were confused about their purpose.Some staff provided examples of when patientshad been in the CDUs for much longer than theduration outlined in the policy for emergencycare, some for three days or more.

A range of senior nurses, senior and middlegrade doctors all reported that the units werebeing used inappropriately, in that they wereused to avoid breaches of the target forpatients to wait no longer than four hours.Many other interviewees also reported thatthe CDUs were used as a means of avoidingbreaching the four-hour target. The ‘assessand treat’ area was described as a “dumpingground” with patients being admitted to “stopthe clock”. The review by the Heart of EnglandFoundation Trust also noted that at least threestaff confirmed that the ‘assess and treat’area operated primarily to stop the clock onthe time patients had waited in A&E.

One of the main concerns among staff weinterviewed was about the staffing of theclinical decision units. The policy foremergency care stated that the staffingestablishment and skill-mix had been set toreflect the number of beds and the patient'sneed at this stage of their care pathway.

However, most staff interviewed reported thatthe clinical decision units were not adequatelystaffed, with some pointing out that thesmaller area was not actually allocated staffat all. We noted that the ‘assess and treat’area was not staffed overnight because ofshortage of staff. As a consequence, patientsin this area were not monitored. As a nursewas not always present, coupled withconfusion about which patients should becared for on the unit, more than one memberof staff thought the unit was ”an unsafeenvironment for patients”.

The review by the Heart of England NHSFoundation Trust found that there was aserious concern about the role of the ‘assessand treat’ unit. It was not clear what this areawas used for, apart from to provide capacity intimes of crisis or poor availability of beds.Patients who were quite unwell were placedin the unit without a dedicated nurse to lookafter them. The review recommended that thearea should be closed immediately to avoidsignificant issues with the safety of patients.The trust acted on this recommendation.

Senior members of the department reportedthat experienced nurses were taken awayfrom A&E in order to staff the 12-bed clinicaldecision unit.

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Governance in A&E

We were told by staff that there were fewprotocols and pathways in use in thedepartment. The review of the department bythe Heart of England Foundation Trust notedthat there was a lack of up-to-date emergencydepartment guidelines or evidence-basedpathways available for staff in the departmentto use. Interviews with some medical staffreferred to the West Mercia guidelines, but fewwere aware of these or had seen them in thedepartment, although they were available onthe trust’s intranet.

The department had forms for staff to use forpatients on multi-disciplinary pathways. Thiswas commendable, but it was unclear at whichpoint in the patient's care they were started.There was no clarity about which patientsshould be admitted to the clinical decisionunits following assessment in A&E. In August2005, problems were identified with thispathway by an audit of the National ServiceFramework for Older People. This describedpressure to move patients quickly, to ensurethat discharge goals were achieved, andhighlighted the issue of older patientstransferring from A&E to the clinical decisionunit where assessments used to gaugesuitability were not always accurate.

There was little clinical audit in thedepartment. What there was, was almostentirely carried out by doctors in training aspart of their required programme. Whenaudits were completed, they appear not tohave been acted on, even though some resultsshowed an unsatisfactory clinical situation (forexample, the adequacy of pain relief inchildren). The directorate manager admittedthat there were no regular audits in place,other than the monitoring of breaches of thefour-hour target. The investigating team fromthe Heart of England Foundation Trustreported that there was no information fromroot cause analyses relating to the breaches.Middle grade doctors, junior doctors andnurses told us that they were not aware thatthe department had arrangements for clinicalaudit, and that audit was seldom discussed.

It was reported in the audit committeeminutes in May 2007 that A&E was one of theareas in the trust where little progress hadbeen made on audit recommendations.

There were no meetings to discuss mortalityor morbidity (that is, complications or adverseconsequences of treatment) within thedepartment. There was, therefore, nosystematic feedback for discussing mortalityor morbidity. There was no systematicmonitoring of patients who had to return tothe department because their problem had notresolved or their condition had deteriorated.

Investigation into Mid Staffordshire NHS Foundation Trust52

• The decision to admit to A&E all patientsreferred by GPs had increased pressureon the department.

• Staff were not clear about the purpose ofthe clinical decision units and the policydid not clarify the situation.

• Most staff said that the clinical decisionunits were used to avoid breaching thefour-hour target for waiting in A&E.

• Nurses thought that much of the problemwas the lack of beds in the trust, but feltthat they were blamed for breaches of thetarget.

• The ‘assess and treat’ unit (the smallCDU) was not staffed and was not a safeenvironment for patients.

• Staff considered that the trust had givenhigher priority to achieving the four-hourtarget than to providing safe care topatients.

• The focus on meeting the four-hour targetput pressure on trainee doctors to makerapid decisions on patients either todischarge or admit.

• Between April and September 2007, 39patients returned to A&E within sevendays. The trust reported only one suchattendance.

Findings of fact on the clinicaldecision units and the trust's focuson the four-hour target

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53Investigation into Mid Staffordshire NHS Foundation Trust

We were told by all grades of doctors that,partly as a consequence of low numbers ofmiddle grade and senior doctors, and lack oftraining opportunities, junior doctors rarelyreceived feedback on their performance. Oneexplained that they might only pick up errorsthat had been made by staff a number of daysafter they occurred, if at all, and therefore theopportunity to educate and learn from thesewas often missed.

An electronic incident reporting system was inuse in the trust. Most members of thedepartment reported that they did not receiveany feedback after completing incidentreports. A small number reported that theydid not fill out incident forms as they were a“waste of time”. A middle grade doctorexplained how they regularly completedincident reports when they felt that pressurein the department compromised care, but saidthat nothing changed and referred to incidentreporting as a "black hole". Nurses informedus that there was no formal feedback aboutcomplaints made by patients.

The clinical staff that we asked reported thatthere was no formal discussion of seriousuntoward incidents. A senior member of thedepartment explained that managers receivedfeedback on serious incidents butacknowledged that staff “on the shop floor”received limited feedback from these. Thiswas of concern, since there had been anumber of serious untoward incidents in A&E.Some of these were examples of repeatederrors, such as giving penicillin to patientswho were allergic to it. This happened inOctober 2005 and again in January 2007.

We were told that there were no regularmeetings of staff in A&E. There had beenattempts to introduce meetings but thestaffing levels and pressure of work meantthey were cancelled. Multi-disciplinarybriefing meetings at the handover of shifts didnot include medical staff on a regular basis.

A large number of staff reported thatappraisals had not taken place for medical,nursing, reception and portering staff. Variousreasons were given including there being toolittle time, the department was too busy, or

there were insufficient senior staff. It wasreported that some staff had not hadappraisals for about two years, although thiswent back as far as five years for some staff.Two members of staff who had receivedappraisals, including a senior clinician,thought that the appraisal itself was nothelpful in that the issues raised about thedepartment were not addressed.

Emergency assessment unitAn emergency assessment unit (EAU) hasbeen defined as an area where adult patientsadmitted as emergencies are assessed andinpatient hospital teams undertake initialmanagement. It is designed to provide skilledassessment of the need for investigation,treatment or discharge. The first 48 hours arevery important in producing successfuloutcomes for acutely ill patients.

The rationale for the use of an EAU is thatsuch units can provide a timely service forpatients in whom there is diagnosticuncertainty, and who may or may not need

• There were few protocols or pathways in use.

• There were no meetings to discussmortality and morbidity (complications oftreatment).

• Junior doctors did not get feedback ontheir performance.

• There were no reviews of patients who hadbeen discharged from A&E but who had toreturn.

• The only clinical audit was undertaken bydoctors in training. When these indicatedthat action needed to be taken, it seldomhappened.

• Staff had little confidence in the systemfor reporting incidents. Serious incidentswere not discussed by clinical staff as partof a systematic process to learn lessons.

Findings of fact on governance in A&E

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admission. They can reduce both the workloadof the emergency department and the lengthof stay in hospital for patients. The systemshould be designed to provide rapidassessment, diagnosis, observation andtreatment dictated by clinical need. An EAUshould ensure timely access to specialty care.Standards set by the Society for AcuteMedicine state that there should be adesignated lead clinician and a dedicatednurse or clinical manager in charge of an EAU.

The review by the National ConfidentialEnquiry into Patient Outcome and Death(NCEPOD) in 2007 of emergency admissionsshowed that the vast majority of acute trustsoperated assessment units (97.7%). Fewerthan 10% of the trusts reviewed had an EAUthat was open to medical, surgical and traumapatients, rather than just medical patients.This was the position at the trust.

In 2003, the National Clinical Director forEmergency Care stated that an assessmentunit must not be an admissions ward, a holdingbay or a “dumping ground”, or an extension ofA&E. Instead such units should be:

• An appropriate environment for patientsand staff.

• Where emergency patients are assessed,with a clear operational policy onadmission, discharge, lengths of stay andclinical support.

• A catalyst for examining and developingpatient pathways.

• Where total lengths of stay are limited tothe period of intensive investigation andobservation.

• Able to route patients to the right specialityward for their needs.

Sources of evidence

• Interviews with staff past and present

• Interviews with patients and relatives

• Observations carried out by members ofthe investigation team

• Complaints

• Trust documents

• Guidance from NICE, NCEPOD, the RoyalCollege of Physicians, and the Society ofAcute Medicine

The EAU at the trust opened in August 2004. Itreplaced a medical assessment unit and asurgical short stay unit. Since April 2006, theunit has been part of the medical division,prior to which it was under the clinicalstandards directorate. The operational policystated that the unit was introduced to improvecare for adult acute patients referred bygeneral practitioners and to ease pressure onthe A&E department. The unit at the trust wasin the minority, in that it took medical,surgical, trauma and gynaecological patients,rather than just medical patients.

The layout and environment of the EAU

The EAU was designed to occupy an areapreviously taken by two wards. The unit openedwith 48 beds. This was a large unit for ahospital of this size. Twelve beds were removedin May 2008, reducing the number to 36. Bedshad temporarily re-opened later in 2008 whenthe trust was under pressure. The trust saidthat additional bank and agency staff had beenbooked. However, staff considered there werenot enough staff to look after the extra patients.

During the initial phase of deciding whetherwe needed to conduct this investigation, theHealthcare Commission undertook anunannounced visit one evening in February2008. This included visiting the EAU, which atthat time had 48 beds. We noted that it was alarge area with a difficult layout. In particular,there was an eight-bedded area that could notbe observed from the nurses' station. Duringour visit, there was no member of staff in thisarea and we had to help an elderly patient atrisk of falling out of bed. We raised ourconcerns at the time with the nurse in charge.

These eight beds, with four others from thesame end of the unit, were removed in May2008. They had been used for patients on theunit for almost four years. Staff described

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55Investigation into Mid Staffordshire NHS Foundation Trust

them as "secluded". A patient who came to seeus told us that they had been “tucked away” ina corner away from the nurses' station.

A few senior doctors were critical of thedesign and layout of the unit. For example,one commented that it was easy to lose yourpatient in the unit. The geography of the unitwas referred to as poor. We were also toldthere were not enough single rooms to be ableto isolate patients with infections.

Doctors also told us about the lack ofequipment. For example, although patientswith fractures and other traumatic injurieswere often admitted to the unit, there were nofacilities for traction.

How the EAU operated

The current operational policy was written inAugust 2004 and reviewed in December 2005.It stated that the aim of the EAU was to assesspatients on the unit before they weretransferred to an environment appropriate tomeet their need.

A number of staff, including consultants, a sitemanager and a ward manager, were of theopinion that the unit did not operate as aproper assessment unit, but as a ward.

In the meeting of the hospital managementboard in November 2005, it was noted thatsome patients on EAU were there for five tosix days. According to the trust’s policy, themaximum length of stay on the unit shouldhave been less than 72 hours. However, amember of senior staff on the unit explainedthat, to be able to achieve this figure, the unitwould require more than 48 beds, given thenumber of admissions and average lengths of stay.

The investigating team visited the unit onseveral occasions and noted it to be a busy,noisy area. Emergency assessment units areprobably the clinically busiest areas in anyhospital. Several interviewees referred to theunit as "chaotic" while others described it as"manic" or a "mad place”. The director ofnursing opted for "frenetic" and considered thatit was comparable to other EAUs in other trusts.

Most patients and relatives who came to seeus also described the EAU as "chaotic", whileone described the situation as a "crisis”. Thenurses were reported as being extremely busyand we were told it was not uncommon forbuzzers to be sounding for up to 40 minutesunanswered.

Infection control in the EAU

The trust's figures showed that there hadbeen a rise in patients on the EAU who wereconfirmed as MRSA colonisation positiveduring the first three months of 2008.However, nearly all these infections wereacquired in the community. There had been 42such cases between January and March 2008,compared with a total of 20 cases in 2006 and27 in 2007.

In an audit by the trust of infection control for2007/08, the EAU was the only area that wasscored as “minimal compliance” and had thelowest overall score. The audit covered handhygiene, environment, kitchen, waste, bodyfluid spillages, protective equipment, sharps,specimens and decontamination. The score of50% compliance for the unit's environmentwas the lowest individual score in the audit.Seventy-five per cent reflected minimalcompliance.

There were six side rooms on the EAU used toisolate patients. During three visits to the unit,we found that the doors to isolation rooms hadbeen left open. The staff justified this bysaying it was to allow the staff to observe thepatient, or in one case due to the patient'sclaustrophobia. However, the general view isthat this is not appropriate unless the risk ofshutting the door has been formally assessedto be greater than leaving it open.

Patients and relatives who came to see usalso reported that doors to isolation roomswere commonly left open on the unit. Anumber of people told us about medical andnursing staff not washing their hands, usingalcohol gel or wearing gloves when handlingpatients or moving between patients. Therewere several instances in which cleanlinesswas criticised, with examples of blood, faeces

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and dust not removed. This was particularlythe case for patients admitted in 2006 and2007. There were reports of too few cleanersand cleaning staff not cleaning properly. Dirtycommodes were described, as were soiledbedsheets.

Admissions to the EAU

In 2003, the National Clinical Director forEmergency Care suggested that, if a patientfrom A&E required an inpatient bed, theyshould not have to be admitted via anassessment unit but should go straight to theappropriate specialty bed. Due to the limitedavailability of beds and how this was managed,the majority of patients were admitted to theEAU. Some patients were admitted to thecritical care unit, but most other acutely illpatients had to be admitted initially to EAU.Similarly, although some patients with heartattacks went straight to the acute coronaryunit, others were admitted to the EAU.

Some staff we interviewed suggested that thepressure on the EAU to admit patientsstemmed from the necessity to meet the four-hour target in A&E. Indeed, it was reported bysome that this was why the unit had beenestablished. Some interviewees, includingseveral consultants, thought that the EAU wasprimarily a "holding bay" to take pressureaway from A&E.

Staff from the A&E department described howpatients were moved from the department tothe EAU if the 'breach time' for the four-hourtarget was approaching. Some members ofstaff said that this often happened before thepatient had been properly assessed in A&E.Junior and middle grade doctors explainedthat when patients had been waiting in theA&E department for some time, theassessment of the patient and subsequentdecisions for care had to be rushed in order toavoid breaches of the target.

Several senior doctors described the situationas a culture of “admit to decide” rather thanthe preferred option of “decide to admit”.

It was reported to be difficult to transferpatients from the EAU to the specialist bedsthey required. A senior nurse said that somepatients on the EAU should not have beenthere but could not be moved due to lack ofavailable beds in specialist areas. Thisincluded patients who should have been in theacute coronary unit.

Several members of staff from other parts ofthe trust thought that surgical patients werenot always well managed on the EAU. Theythought this was because there were nospecifically skilled surgical, trauma ororthopaedic nurses on the unit.

Doctors and nurses with particularresponsibility for the care of patients withstroke considered that the EAU was not a goodenvironment or equipped to deal with strokepatients.

A consultant in care of older patients did notthink the unit was equipped appropriately forelderly patients and another questionedwhether a busy, noisy unit was an appropriateenvironment for them to be treated in.Relatives who came to see us also raisedconcerns over how elderly patients weretreated on the unit. For example, we were toldabout an elderly patient who had been leftunattended on a commode and had fallen tothe floor.

The trust undertook an analysis of traumapatients admitted to the trust between Apriland September 2008. It showed that 125patients in this period (10%) were admitted tothe EAU. The chief executive acknowledgedthat this resulted in unnecessary delays inpatients being admitted to the trauma ward.

Patients should not move back to the EAUonce they have moved to a specialty ward or totheatre. The trust's operational policysupports this. However, we were told that thisdid occasionally occur at the trust, both fromtheatre and from the critical care unit.

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Staffing levels on the EAU

The operational policy outlined that thenursing staff levels and the skill-mix would bedriven by the need of the service on the unit.The policy listed a minimum number of stafffor the provision of a high standard of care andservice. The daily staffing level on the unit wasnot to fall below the minimum, as the unitwould receive patients who requiredemergency assessment, treatment and care.

On our unannounced visit in February 2008,the staffing on the ward was slightly below theminimum figures. A senior nurse interviewedat the time told us that more staff wereneeded. This was because the nurseconsidered that the number on a shift was toofew to provide appropriate care whilecontinually receiving further emergency

admissions. This was particularly the case in alarge ward with poor geography and manyseriously ill patients.

We were told that, when the EAU first opened,it was intended to have a staffing ratio of onequalified nurse to every six patients, on parwith the recommendations of the Society ofAcute Medicine. The unit opened with goodstaffing levels. Indeed, we were told thatinitially staff were taken from other wards towork on EAU. The trust’s plan for cost-improvement in 2006/07 resulted in areduction in staff numbers, as the funding forstaff was cut. There was also a freeze onvacancies as part as a trust-wide reduction inthe workforce. Furthermore, the managerduring this period was frequently asked to cutstaffing levels and review the skill-mix on theunit. At the end of 2007, we were informedthat the nurse to patient ratio was closer toone qualified nurse to every 15 patients. Onenurse told us she and one healthcare assistanthad once been responsible for 17 acutelyunwell patients. She described it as“impossible”.

The staffing levels were reviewed as part ofthe wider review of skill mix, which wasstarted in mid-2007 and which took account ofthe type and throughput of patients. Followingthe review of skill mix, the establishment ofnurses was increased. The benefits of thisincrease had yet to be fully felt in mid-2008,particularly as there were five whole-timeequivalent nurses on maternity leave. Thoseon maternity leave were said to be some of themore experienced and competent members ofstaff.

It was recorded in the risk register for themedical division in April 2008 that there hadbeen a shortfall of staff in the EAU becausethe nursing bank was unable to fill the gaps instaffing. The entry continued that this wasleading to increased complaints and was“compromising patient safety”. There wereconcerns there would be a repeat of aprevious serious untoward incident. This hadinvolved giving an infusion of the wrongsolution and is described later.

• The environment and layout on the EAUwere not good for patients or staff,particularly when 48 beds were openbetween 2004 and May 2008.

• The EAU was described by staff andpatients as busy, chaotic and frenetic, andas a poor environment for older patientsand those with strokes.

• The EAU had the lowest score, that ispoorest performance, in an audit ofinfection control carried out by the trust in2007/08.

• The system including EAU was noteffective in sending patients to the wardsmost appropriate for their care.

• The capacity of EAU was not planned inrelation to clinical demand and patientflow.

• Patients were often admitted to the EAUbefore proper assessment had taken placein A&E.

• There were concerns about themanagement on EAU of surgical patientsand those with traumatic injuries.

Findings of fact on the environment,infection control and admissions to EAU

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We were told that it was often hard to get bankstaff to work on EAU because it wasunpopular, due to the pressure on staff. Theunit could not rely on agency staff as it wasdifficult to get staff with the required skills.

The ratio of nurses to patients improved when12 beds were removed in May 2008. In July2008, there was the equivalent of one qualifiednurse to every 10 patients.

Although some staff told us that staffing levelswere acceptable, many more described theEAU as "dreadfully understaffed" or that therewere "absolutely not" enough nurses, with the2007/08 winter period identified as"particularly stretched”.

Patients and relatives of patients who hadbeen treated on the EAU had a generalimpression that the unit was short-staffed. Asa consequence of this, patients reported notgetting basic care, such as washing and beingescorted to the toilet. There was a lack ofsupport noted for patients needing help to eat,including an elderly arthritic patient whoneeded help to unpack and cut up her food.One patient told us that EAU was generallychaotic, filthy and there was a lack of basichygiene control; for example he did not seeany hand washing. Weekends and late in theevenings were thought to be the worst time forstaff levels.

Insufficient staffing can adversely affectcommunication. This was described by thestaff on the unit, staff elsewhere in thehospital and the relatives of some patients.Doctors and other healthcare staff basedoutside the EAU blamed insufficient numbersof staff on the unit for difficulties in finding anurse who knew about their patient. A juniordoctor told us how families would often “grab”doctors as they walked by, to ask what washappening to their relative. Anothercomplained there was not enough time toexplain to patients what was happening, andthis could lead to patients becomingfrustrated. A manager listed communicationbetween nursing staff and relatives as acommon theme of complaints, and mentionedthis was related to staffing levels. Tworelatives who contacted us complained there

was a lack of interaction between the nursesand the patients.

Several senior doctors told us that, due to lowstaffing, the nurses were generally too busy toaccompany doctors on their ward rounds. Thismeant that essential opportunities tocommunicate about the condition andtreatment of the patient were reduced.

We were told by patients and relatives thatthere had been problems with medication onthe EAU. An audit by the trust in July 2006found that 39% of prescriptions wereincorrect. Some of the errors were the wrongdose, others were errors of omission. Anotheraudit in June 2007 found that 29% of theprescriptions on the EAU had either missingor incorrect details entered on the forms. Italso found that there was an average of 2.6errors on 18 out of 53 treatment sheets.

There was a further audit of drug prescribingon the EAU in January 2008. This looked at100 drug charts and compared them to trustpolicies. The main findings were that theidentity of the prescriber was clear on only24.3% of charts; allergies were not recordedon 14%; just under 10% were not legible; and73.5% of the prescribers were junior traineedoctors.

Medical staffing on the EAU

In 2004, the Royal College of Physiciansrecommended that, by 2008, there should beat least three consultants with primaryresponsibility for acute medicine in everyacute hospital. In August 2006, the clinicaldirector for medicine acknowledged thathaving just one single-handed acute physicianwas an "immediate problem”. The acutephysician was an acting locum consultant. Theappointments of acute physicians wereconsidered a priority, but it took nearly twoyears before the EAU had a complement ofthree acute physicians.

By May 2008, the trust had three dedicatedacute physicians, two appointed in 2008. Thisis to be commended, although their inclusionin the rota for covering A&E has already beenidentified in this report as inappropriate.

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Training for nursing staff and observations ofpatients by nurses

The operational policy for the EAU outlinedthat the education of nurses in the unit was anongoing process to meet the needs of thepatient. It said that nurses would be able todemonstrate their competencies to providecare to “level two patients”, in other wordsthose patients that need monitoring andpatients with severe co-morbidity (that is,other health problems in addition to theirmain diagnosis). The Department of Health'sreview of critical care in 2000 identified “leveltwo patients” as those requiring more detailedobservation and intervention.

During 2006/07, all staff on the EAU hadtraining on immediate life support. In 2007/08,staff were released for training on basic lifesupport during the first two months only. Thetraining sessions were said to be atinconvenient times for staff on the unit.

In July 2008, members of staff confirmed thatlittle training, including mandatory training,had been undertaken for the past 12 months.They expressed concern about how long itwould take to bring training up to date. Themain problem was said to be the difficulty in

releasing staff for training due to staffinglevels on the unit. It was reported in thegovernance meeting in July 2008 that the EAUwould be depleted if staff left the unit toundertake training.

With regards to more advanced training, theoperational policy for the unit specificallydescribed advanced life support as a skill thatwould be available on a 24-hour basis on theunit. In July 2008, only one member of the unithad been trained in advanced life support.

There were reports from interviews with staff,qualified nurses and healthcare assistantsabout having to perform tasks without thenecessary training. Three areas mentionedwere modified early warning scores (MEWS),cardiac monitors and fluid balance charts.

The MEWS system has been described earlierin this report. It is used to monitor the clinicalprogress of patients and is particularly usefulto identify patients at risk of seriousdeterioration in a busy clinical area. Theinvestigation team observed a number ofinaccuracies in MEWS scoring due to simplearithmetical errors and, on occasion, a failureto highlight clinical escalation fordeteriorating patients. There were a numberof patients whose scores should havetriggered a referral and yet this had nothappened. We raised this issue with the trustand were informed that MEWS had beenidentified by the trust as an area wheretraining was necessary in order for all staff tobecome confident in use of the charts. It wasexplained that problems with the charts weredue to the recruitment of newly qualifiednurses who required education in order toachieve the same level of competence as themore experienced staff.

We were also told that risk scores for patientswith pneumonia were not done in A&E or onthe EAU.

There were 10 bed spaces set up with cardiacmonitors on the EAU. We were told that thestaff originally employed on the unit in 2004had been trained to use the cardiac monitors,but since then it had been difficult to releasestaff for training. We learned that there had

• The ratio of nurses to patients by the endof 2007 was approaching one qualifiednurse to 15 patients, compared to therecommended one to six. By mid-2008, itwas one to 10.

• Most staff thought there were too fewnurses.

• Many staff, and many patients andrelatives, were concerned about poorcommunication. Nurses were often unableto accompany doctors on ward rounds.

• Since May 2008, there have been threeconsultants in acute medicine withprimary responsibility for the EAU. Theyhad additional responsibilities in A&E.

Findings of fact on how the unitoperated and on staffing

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been no training on cardiac monitors for acouple of years. When we visited in July 2008,we found that most staff working in themonitored bays had not been trained to usethe monitors and did not understand them. Asenior nurse from another area reported that,when she visited the unit and the alarm on themonitor sounded, the nurses did not know whythis occurred. Senior nurses in thedepartment admitted that the cardiacmonitors were often turned off, or not usedwhen necessary, because the nurses did nothave the skills to use them.

One of the patients who came to see us told usabout his experience in October 2007. Hesuffered a heart attack on a Sunday and wasadmitted through A&E. He was initially sent toEAU for 24 hours before being moved to theacute coronary unit on the Monday morning.While he was complimentary about the acutecoronary unit, he thought EAU was “terrible”and noted there was a big disparity in carebetween the two areas. He was concerned thatthe service on Sunday was particularly poor.He reported that his condition was notmonitored appropriately while in the EAU. Hisblood pressure had fluctuated causing themonitor to alarm, but no member of staff hadcome to check on this.

An audit of inpatient cardiac arrests, reportedto the EAU’s governance meeting in July 2008,showed that a large number of patients on theunit were succumbing to cardiac arrest.

During a visit to the unit, we found that mostpatients who required fluid balance charts hadthese in place. However, of 16 patients, onlyone chart had been completed to show thebalance over 24 hours. A specific example wasalso observed of a very acutely ill patient whohad been admitted late at night. This patient inthe cardiac bay was on diuretics, with aninfusion of intravenous fluid and hourlyobservations. We noted that fluid balance hadnot been recorded.

On another visit, we observed that nurseswere not using infusion volumetric pumps toaid the administration of intravenous fluids. Onone night shift, we saw that most of the

intravenous drips in progress were freerunning and not on the pumps, which wereavailable on the drip stands. We observed 20intravenous infusions on patients and foundonly two to be running on time. The majoritywere running considerably behind time, andone was being infused far too quickly. In oneinstance, the intravenous fluid had been put upat 8.45 am to run at the rate of one litre overeight hours. However, the pump was not beingused and the first litre was still running at10pm. This patient had been admitted withdehydration as one of their problems. Itappeared the nurses were not familiar withhow to use the pumps.

This issue was raised with the trust and, onsubsequent visits, more of the infusions thatwe observed were running on time.

The operational policy for the EAU stated thatnurses would be able to provide care topatients who require more detailedobservations and intervention. Observationsare a basic element of caring for patients andinclude measures such as heart rate,respiratory rate and blood pressure.

Several staff that we interviewed reportedproblems generally with staff conductingobservations. These ranged from staff sayingthere was a poor standard of observations,especially at night, to a consultant reportingthat when he was a patient on the unit no oneperformed observations overnight, despite thefact he had been fitted with a chest drain. Adoctor who had nearly completed theirspecialist training told us that they had oftenasked for regular observations but these hadnot been done to a satisfactory level, eventhough the patient required critical care.

One senior doctor expressed concern thatthere was no effective prioritisation system onthe EAU and, therefore, patients were seen ina chronological order rather than according totheir clinical condition. A patient who had to bemoved from the EAU to the critical care unitwas upset that no observations had beenperformed on the EAU, although they requiredcritical care.

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61Investigation into Mid Staffordshire NHS Foundation Trust

Additional concerns raised with us were that,at weekends, staff did not pick up abnormalblood test results. Not everyone had access tothe computer, so abnormal pathology wasmissed.

In November 2007, a report was made to theclinical quality and effectiveness group thatthe unit was one of two areas across thehospital that did not comply with tissueviability audits. The audits were to establishwhether there was appropriate care ofvulnerable patients’ skin and adequateprevention of bed sores.

In July 2008, we raised our concerns directlywith the director of nursing about poortraining of nurses and poor quality ofobservations. In September, she provided uswith information on planned and actualdevelopments in nursing. These are detailed inthe chapter on developments.

• Training had initially been established, butthere had been limited training during2007/08.

• When we visited in July 2008, only onemember of staff on the unit was trained inadvanced life support.

• Nurses were not using the modified earlywarning score appropriately.

• Nurses were not trained in the use ofcardiac monitors. On occasions, thesewere turned off.

• Observations and monitoring of patientswere patchy and not consistentlyperformed to the required standard.

• On one visit, only two of 20 intravenousinfusions were running on time. Onsubsequent visits, more were found to berunning on time.

Findings of fact on training of nursesand observations of patients by nurses

Medical admissions and the care ofpatients admitted as medicalemergenciesWe looked at what happened to patients whowere admitted to a ward from the emergencyassessment unit. Most patients admitted asemergencies have medical rather thansurgical conditions. The proportion nationallyis 79%. These conditions include heartattacks, strokes, respiratory conditions suchas asthma or chronic lung disease, problemsassociated with diabetes, and various otherdisorders of glands, the stomach, bowels andso on, that do not require surgery.

The medical wards in the trust were re-organised and reconfigured into ‘floors’ in2006. This is covered in more detail later in thereport. Floor one at Stafford Hospitalconsisted of wards 1 and 2 and the acutecoronary unit (ACU). The floor had 44 beds:eight of these were ACU beds and 36 werespecialty beds for patients with cardiac,endocrinological and haematologicalconditions.

Floor two at Stafford Hospital consisted of 78beds. The specialties covered wererespiratory, gastroenterology, elderly care andstroke. It consisted of wards 10, 11 and 12.There were 38 beds on ward 10, with four ofthose being for patients with acute stroke; 21beds for patients with gastroenterologyproblems on ward 11; and 19 beds forrespiratory patients on ward 12.

Sources of evidence

• Interviews with staff past and present

• Interviews with patients and relatives

• Healthcare Commission’s national inpatientsurveys

• Observations carried out by members ofthe investigation team

• Observations by South Staffordshire PrimaryCare Trust during an unannounced visit

• Complaints

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Ward 10 is a ‘T shaped’ ward with 38 beds andthe staff are divided between three areas. Likethe emergency assessment unit, it was anawkward area to nurse because of its layout. Italso had very dependent patients. Theproblem caused by the layout of the ward wasexacerbated by lack of staff. Wards 11 and 12together constituted a large area, again withdependent and seriously ill patients, so whenstaff numbers were low this was alsoproblematic.

Staffing and standards of care

As noted above, the reconfiguration of themedical wards into 'floors', as opposed towards, led to a reduction in the number ofqualified nurses, particularly more seniorward nurses. The changes took placegradually during 2006. The result was just onesenior sister (band seven) for the 78 beds onfloor two. Although this was meant to beoffset by the appointment of more and bettertrained health care workers, the requirementto save money meant that overall staffinglevels were in fact reduced. The previousdirector of nursing left in July 2006. She statedthat she did not have operationalresponsibility for these changes and had norecollection of being asked for advice.

During most of the period covered by thisinvestigation, there was one matron for themedical division in the trust who was the leadprofessional nurse, but not the line managerfor the nurses in the division. Senior nursingstaff, consultants, therapists and managersdescribed the leadership of the wards on floortwo as being weak. In April 2008, clinical stafffrom South Staffordshire Primary Care Trust(PCT) undertook an unannounced evening visitto floor two. They concluded that one sisteracross all three ward areas was not sufficientfor leadership, team building and the cultureof the team. The trust has said that the needfor an additional senior nurse (band seven)was identified as part of the establishmentreview and support to fund this was agreed atthe March board meeting.

• Trust documents including performancemonitoring reports, minutes of meetings,risk registers, SUI reports, audit resultsand analysis of complaints

• Statements provided by the trust

• The trust’s website

• Relevant guidance on national websites

• External reports, including the SentinelStroke Audits in 2006 and 2008

• Absence of evidence

The reconfiguration of the medical wards

In May 2006, the proposal to change theorganisation of the medical division noted, inits introduction, that the trust would beentering 2006/07 with an underlying debt of£2.158 million. However, the trust wasexpecting, as a minimum, to have a gap of £10million between its income and expenditure.The trust requested the medical division tomake a total saving of £580,000 as acontribution towards closing this gap. Theproposal identified a potential cost saving of£325,000. Other savings were referred to butnot detailed in the proposal.

The proposal also set out to alter the seniorityand skill mix of the nursing workforce. Overall,there were to be 6% more staff but theproportion of senior staff (band seven) was toreduce by nearly 60%. The previous director ofnursing had no recollection of being asked foradvice regarding these changes to skill mix.The detail of changes to staffing at the trust iscovered in another chapter.

Many consultants told us that they hadopposed the reconfiguration of the wards andthe reduction in nursing staff.

The environment of the medical wards

When we visited the wards, we found that theywere generally clean and tidy, except on anunannounced visit in February 2008 when wewere concerned about the cleanliness of thewashing facilities and toilets on wards 10 and 11.

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63Investigation into Mid Staffordshire NHS Foundation Trust

Many staff from a range of healthcareprofessions expressed their concerns aboutstaffing levels on the medical wards,especially on floor two. The review of thenurse staffing levels and skill mix in theautumn of 2007 found that the biggestshortfall was in medicine, where nearly 77more whole-time equivalent staff wererequired. The director of nursing took a paperto the trust's board in March 2008 to remedythis shortfall.

Many staff told us that, on the medical wards,staff sickness was high and had been forsome time. The reports in 2006 on corporateperformance to the trust's boarddemonstrated that sickness levels were highacross the whole the trust and highest in themedical division. The corporate performancemonitoring reports from April 2007 alsoshowed that staff absence due to sicknesswas highest in the medical division. The PCTwas told this when it conducted its visit inApril 2008.

The main concerns of staff, relatives andpatients related to staffing levels and theeffect of having a low number of nurses. Thiswas particularly the case for the wards onfloor two, consisting of wards 10, 11 and 12.When the PCT conducted its unannouncedvisit to wards 11 and 12, they found that thenurse staffing on the ward was below theestablishment, and that staff had been toobusy to communicate with patients and theirrelatives. One patient had been in a soilednightdress since lunchtime.

Staff told us that they had complained orcompleted incident reports when they wereconcerned. The trust supplied informationabout incidents that staff had reported forwards 10, 11 and 12. This information showedthat, between April 2005 and August 2008, themost frequently reported incidents related tostaffing levels and lack of suitably trained orskilled staff; collectively these represented37% of all the issues reported by staff. Ward11 had generated as many incidents as theother two wards put together.

Patients and relatives that came to see usalso expressed more concerns about nursingcare on ward 11 than any other ward. Onerelative said that "some nights it was a warzone" and that “the family were doing lots forother patients who didn’t have their relativeswith them. They were helping them to go tothe toilet or they were helping them to eat”.

Another told us that her mother was in the farcorner of a four-bedded bay on ward 11. Shesaid: "The nurses told her to ring the buzzer,but because of her paralysis she could not usethe buzzer. When someone else used it on herbehalf, it often would not be answered."

A number of staff in different professionsraised concerns about the lack of basicnursing care, such as poor hydration andnutrition of patients, and failure to helppatients eat or drink. Some said there was anegative attitude among some of the nurses,with relatives who complained being seen asdifficult.

Care was also criticised on the other medicalwards on floor two. It was described as beingvery poor, with buzzers not being answered,privacy and dignity ignored, and patientsreceiving little or no help with food or drink.

There was evidence going back to 2005 ofconcerns about these wards. In the trust’sreport on complaints for July to September2005, there was specific reference to wards 11and 12. In a letter from the trust in June 2005in response to a complaint, the trust notedthat staffing levels had been an issue on ward12 and that the basic standard of care couldbe compromised when the ward was shortstaffed.

In the summer of 2005, a complaint wasreferred to the Healthcare Commission aboutcare on ward 11. This concerned lack ofnutritional assessment and care, falls, poorcommunication and pressure sores. Thecomplaint was upheld by the Commission andthe initial response from the trust wasconsidered inadequate. Another complaintreferred to the Commission concerned care ofa patient on ward 11 in December 2006 and

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Staff on the critical care unit had noticed adecline in the level of care on the generalmedical wards and this had hampered theirability to move patients from critical care tothe wards. A consultant told us that an auditon ward 12 showed that scoring of severity ofillness was not being done and that over halfof patients did not get antibiotics within 24hours of them being prescribed. We notedthat, in the report on incidents to the clinicalquality and effectiveness group in December2007, there had been a “catastrophic” incidenton ward 12 that was due to failure to monitora patient’s condition.

A third of the patients and members of thepublic that came to the HealthcareCommission told us that patients did notreceive the correct medication or were giventhe wrong medication. A related issue wasthat help was not always available for patientsto take their medication. These issues wereparticularly common on the medical wards.

Although some staff said that omission ofmedication was uncommon, a larger numberof staff, including senior doctors, told us thatthey had had to personally insist that patientsreceived their correct medication, thatomissions happened and that there could bedelays before patients received theirmedication. There were no pharmacists basedon these wards. A member of the pharmacyteam confirmed that this was a problem.

Another concern was the development ofpressure (bed) sores. Relatives informed usthat patients suffered pressure sores andsome showed us photographic evidence. Asenior nurse told us that, although on theirward they assessed a patient’s likelihood ofdeveloping pressure sores as one of the firsttasks after they were admitted, this was notalways the case for patients that came tothem from emergency assessment unit. Anaudit by the trust in January 2008 of theprevalence of pressure damage found thatmost pressure sores occurred after patientswere admitted and wards 10, 11 and 12 hadamong the highest rates. For example, 55% of38 patients on ward 10 had some degree ofpressure damage. Only four of these patients

January 2007. It involved failure to assist thepatient with fluids and to monitor fluid or foodintake. This complaint was also upheld. The15 recommendations included that membersof staff on the ward must carry out nutritionalassessments, preserve the dignity of patientsand keep adequate records.

The trust's report on complaints for the firstthree months of 2008 noted that complaintsabout two medical wards, wards 10 and 11,had been of some concern over recentmonths. These wards were averaging twocomplaints per month. Basic standards ofcare were the general themes.

Many medical and nursing staff also describedinstances to us when basic nursing care hadbeen lacking on the medical wards at StaffordHospital. The elements of care they describedas being lacking reflected those mentioned bypatients and relatives. Additionally, theyexpressed concerns about observations anddocumentation not being completed, includingthose relating to fluid balance and tomedication.

Some staff were distressed that they had beenunable to deliver the level of care that theywanted to and had insufficient time to spendwith relatives or to accompany doctors ontheir rounds. One doctor also told us thatphones on the ward would not be answeredfor 20 minutes. We were told that, on oneoccasion, the phone had eventually beenanswered by a patient with dementia.

One bank nurse told us that some patients onward 11 were on percutaneous gastrostomyfeeds. This involves feeding by tube directlyinto the patients’ stomach. No one hadchecked how much had been given and it wasnot clear who had put the last feed in place.The paperwork was not up to date andmorning doses of medication were missingfrom the chart. On ward 10, there wereseveral highly dependent patients and, on oneoccasion, this nurse had found some patientswho had been left lying in bed in their faeces,evidently for a long time. Another nurse toldus that working on ward 11 had made her illand she would never work there again.

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had any pressure damage when they cameinto hospital.

For all hospitals, as patients move to differentwards and areas in the hospital and as staffchange shifts, it is important that appropriateinformation about the condition and care ofpatients is communicated and passed on. Thisis often referred to as 'handover'. Doctors inthe medical division told us that, with regardto the change between shifts, handovers didnot always happen, or were inadequatebecause of shortness of time or confusinginformation.

When new patients arrived on the medicalwards, many nurses told us that the handoverwas often conducted by telephone only, andsometimes only by junior nursing staff.

Although nurses generally told us that theydid receive a handover when they changedshifts, many described these as brief, short ornot as effective as they could be. This weobserved for ourselves when we visited ward10 and spoke to the nurse in chargeimmediately following a handover.

Improvements to staffing levels are noted inthe progress section of the report.

Aspects of clinical care on the medical wards

Care pathways and routes of admission

An integrated care pathway describes the carethat is anticipated, in an appropriatetimeframe, for a patient with a specificcondition or set of symptoms. Care pathwaysare considered important because they help toreduce unnecessary variations in care andoutcomes for patients. Care pathways can alsobe used as a tool to incorporate local andnational guidelines into everyday practice,manage clinical risk and meet therequirements of clinical governance. They alsoprovide benchmarks. A pathway may be variedin order to meet the specific needs of anindividual patient.

• The trust’s reconfiguration led to areduction in the number of senior nurses.

• There were high sickness levels amongnurses on the medical wards.

• There was a low number of nurses,particularly on floor two.

• There was a long history of poor nursingcare on floor two.

• Patients, relatives and staff recountedexamples of poor care.

• Some patients did not receive the correctmedication.

• Handovers were often inadequate forpatients, nurses and doctors.

• In January 2008, 55% of patients on ward10 had pressure sores.

Findings of fact on nurse staffing andstandards of care

We heard variable accounts from doctors andnurses as to whether care pathways wereused regularly at the trust. Most staff said thata care pathway for patients admitted with astroke was in place. There was also said to beone for patients with chest pain or cardiacsymptoms, but many staff said that it was notinitiated for individual patients as early as itshould have been.

Some staff told us there were generalpathways for medical and surgical admissionsand that pathways were being developed.However, many staff, including seniorclinicians, told us that care pathways did notexist or were not used. In a letter to theHealthcare Commission in October 2008, thetrust acknowledged that, while they had somepathways in place, it was an area that wouldbenefit from further development.

We were told there were fewer medicalpatients now on surgical wards than had beenthe case three or four years ago, but manysenior staff told us that many patients stillended up on the “wrong” ward. For example, a

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Nursing staff on the ACU were generallyappreciative about the support they received interms of having regular team or unit meetingsand having access to training. However,nurses did not feel that they consistently hadenough staff and sometimes, when they did,their healthcare support workers would haveto go and help out on other wards. In the past,they had triaged cardiac patients on the EAUto identify those in most need of transferringto the ACU. However, this had not been thecase for a couple of years.

There had been a long-standing problem withthe cardiac monitors on the ACU. At themeeting of the governance committee for themedical division in July 2007, it was noted thatthe machines for monitoring on the ACU were“breaking down”. They were to go back on thecorporate risk register as a high clinical risk.It was recorded on the risk register for themedical division in April 2008 as “failure todeliver a coronary care service due to lack ofmonitors for inpatient care”.

Inpatient services for patients with stroke

The unit for clinical effectiveness and clinicalevaluation at the Royal College of Physiciansconducted the first National Sentinel StrokeAudit in 1998. There have been severalsubsequent national audits. The objective ofthe Sentinel Audit is to assess the quality ofcare for people who have had a stroke and tohelp trusts use audit as a means of improvingthe quality of their services. The audit usesevidence-based standards for the organisationof services and process of care.

In 2004, the Royal College of Physiciansrecommended that imaging of the brainshould be undertaken as soon as possible in

patient with chronic lung disease could bemoved from the emergency assessment unitto the ward for patients with heart problems.They would then be looked after by a heartspecialist, not a lung physician.

The great majority of patients were notadmitted directly to their specialty ward, butadmitted first to the emergency assessmentunit. If there were surgical beds available,patients would sometimes be admitted directto these, but this did not apply in the medicaldivision, other than for some of thoserequiring the acute coronary unit.

Members of the team who specialised in caringfor patients with stroke told us that patientswith stroke were not always in the right placein the hospital and were not admitted directlyto the beds specifically for them on ward 10.

Acute coronary unit

The acute coronary unit (ACU) had eight bedsand was part of floor one of the medicaldivision. We were told by senior staff thatthrombolysis was provided but, although theydid angiograms (a procedure for looking insidecoronary arteries), patients that requiredangioplasty (a technique for improving theflow of blood to the heart by unblockingcoronary arteries) had to go to the UniversityHospital of North Staffordshire.

Patients were generally complimentary aboutthe ACU and staff told us that they thought theservice and care provided by the unit wasgood. They described the environment asclean and said that handovers betweennursing shifts always occurred.

Although some patients were admitteddirectly from A&E, many staff told us thatpatients were not always admitted directly tothe unit. Beds in the ACU were often full,resulting in patients having to be cared for inother areas, often the emergency assessmentunit (EAU). Senior nurses in the unit told usthat not all staff in the EAU were able tointerpret the monitors correctly and patientswere not always started on the appropriatepathway of care. Some patients who came tosee us told the same story.

• Patients were not always located in thecorrect specialty area.

• There were problems with the monitors onthe acute coronary unit.

Findings of fact for routes ofadmission, and the acute coronary unit

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all patients, at least within 24 hours of onset(unless there were good clinical reasons fornot doing so).

In July 2008, the National Institute for Healthand Clinical Excellence (NICE) publishedclinical guidelines for the diagnosis andmanagement of acute stroke. These includedthat all people with suspected stroke should beadmitted directly to a specialist acute strokeunit, following initial assessment, either in thecommunity or from the A&E department.

An acute stroke unit is a discrete area in ahospital that is staffed by a multidisciplinaryteam specialising in stroke care. It has accessto equipment for monitoring and rehabilitatingpatients, and regular multidisciplinary teammeetings. The guidelines also recommendthat, on admission, people with acute strokeshould have their swallowing screened by anappropriately trained healthcare professionalbefore being given any oral food, fluid ormedication.

At the trust, four of the 38 beds on ward 10 atStafford Hospital were for stroke patients.Fairoak ward at Cannock Hospital was alsoused to accommodate patients who had had astroke, mainly after the acute phase of theillness.

In the 2006 Sentinel Audit, the trust reportedan average wait of five to 24 hours for a CTscan on weekdays, longer than 48 hours atweekends, and a wait of longer than 48 hoursfor an MRI scan at any time. Against 12clinical audit indicators that aim to assess thequality of care for people that have had astroke, the trust scored 55% against a regionalaverage of 63% and a national average of 65%.

In the partly released results of the 2008Sentinel Audit, the trust reported the samewaiting time for a CT scan on weekdays and25-48 hours for a CT scan at weekends. ForMRI scans, there was an average wait ofbetween 25-48 hours on weekdays andgreater than 48 hours on weekends. Theseresults show that the trust was not meetingthe guidance of the Royal College ofPhysicians for imaging of the brain to beundertaken at least within 24 hours of onset.

The 2006 Sentinel Audit reported that the trustmet the criteria for an acute unit for strokepatients. However, the subsequent audit in2008 said it did not. This was confirmed to usby staff that we spoke to. Staff also describedthe facilities (four beds) available on ward 10as being insufficient to deal with all the strokepatients that were admitted to the hospital.They confirmed that patients with stroke werenot admitted directly to the four-bedded unit,but had to come via the EAU. They mightremain on EAU for up to four days withoutadequate intervention from therapy services.

Staff told us that access to thrombolysis waslimited to between 9am and 5pm on weekdaysonly. The national target is that 10% of strokepatients should receive thrombolysis, but thefigure for the trust was 3%-5%. Patients whoreceived it were looked after on the acutecoronary unit.

Care of stroke patients and outcomes of care

In the later stages of the investigation, theHealthcare Commission’s surveillancegenerated an alert about high mortalityrelated to patients who had suffered a stroke.The alert involved mortality in the periodbetween January and March 2008. It followedtwo successive quarters when mortality datahad been higher than expected. This wasconsidered by the decision panel in theCommission that deals with such matters. Aletter was sent to the trust in December 2008containing our analysis and asking them tocomment on the findings. The trust replied inJanuary 2009, stating that, among otherthings, it had reviewed a number of the casesand had decided on a range of actions forimprovement. However, we have asked thetrust for further information in order toconsider the matter further.

We were provided with information from thetrust that the mortality from stroke was 18%,above the European average of 15%.

There were mixed views about the use of thestroke care pathway. Most staff said it existedand was in use. However, we were also toldthat some health professionals involved in

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The speech and language therapists reportedthat there had been problems incommunication with ward staff. Whentherapists made recommendations forpatients, these were not always followed up.This was attributed in part to the shortage ofstaff. Examples of shortcomings included poorcare of patients’ mouths, resulting in fooddebris in their mouths and their tongues being coated in “matter”, recommended dietsnot adhered to, staff not consistently providingthe correct diet, and drinks not thickenedwhen they should be or thickened to thewrong consistency.

Non-invasive ventilation

Non-invasive ventilation is an importantelement of the clinical management ofpatients with certain types of lung disease andthose who have problems with breathing. It isa means of supporting breathing through thepatient's upper airway, using a mask orsimilar device. Although a variety of ventilatorunits are available, most centres now use bi-level positive airways pressure (BiPAP) unitsand there is a guideline that refers specificallyto this form of ventilatory support. It has beenproduced for clinicians caring for patients withchronic obstructive pulmonary disease (COPD)in the emergency and ward areas of acutehospitals.

The National Institute for Health and ClinicalExcellence (NICE) recommends that non-invasive ventilation be available in all hospitalsadmitting patients with COPD. This has led toa rapid expansion in the provision of non-invasive ventilation services, with over 90% ofacute hospitals in the UK offering thisintervention. The trust did not have it. Seniorclinicians in the medical division told us thatnon-invasive ventilation was not available topatients but that there were plans to introduceit. The lack of non-invasive ventilation meantthat doctors had to refer patients to thecritical care unit. As the critical care unit oftenhad no space, and on occasions there were nobeds available in University Hospital of NorthStaffordshire NHS Trust, some patients didnot get this service.

looking after stroke patients had to writenotes in multiple places. This suggested thatthe care pathway was not truly multi-disciplinary and was not used as the singlerecord of care. We were told that files wereoften lost or not compiled properly with loosesheets. There were also variable methods ofcase-note completion, some with the mostrecent first and some the other way round.

While some staff said that the care of patientsthat had suffered a stroke was good, moresaid it could be improved. We have alreadyidentified concerns about stroke patientsbeing admitted first to the EAU. We were alsotold about the inappropriate discharge ofpatients to their home or transfer to CannockChase Hospital, resulting in re-admissionwithin a week. Some staff thought thatdecisions about discharge were made on thebasis of needing the bed, rather than on thebasis of what was right for the patient.

We were told about poor communicationwithin the multidisciplinary team especiallybetween doctors and nurses. For example, itmight not be clear that an individual had beenplaced on a special pathway for dying patients.This resulted in mixed messages betweenstaff and family members.

In the 2006 Sentinel Audit of stroke, the trustscored 65% for patients being screened forswallowing disorders within 24 hours ofadmission, which was higher than the averagefor local trusts under the same SHA (62%) andalmost the same as the national average(66%). However, a consultant told us thatmore staff were needed to identify swallowingdifficulties. The stroke nurse was generallycomplimentary about the service provided bythe speech and language therapists, who wereemployed by South Staffordshire PCT.However, she told us that patients had to waitto be seen by speech and language therapists.

The speech and language therapists hadinstructed nurses how to carry outassessments of swallowing, but nurses werereluctant to do them if the consultantrequested an assessment, since they feltconsultants preferred them to be conductedby a speech and language therapist.

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An audit that was part of a national audit onchronic obstructive airways disease found thatfive out of 30 patients could have benefitedfrom non-invasive ventilation but did notreceive it.

We were also told that, even on the ward forpatients with respiratory problems, because ofinadequate training many of the nurses didnot understand about basic elements ofpatients' clinical conditions, such as theiroxygen saturation levels.

• There were four dedicated stroke beds,which was too few for the number ofadmissions.

• Patients were not admitted direct to thestroke beds.

• The trust had no specialist facility for thecare of patients with acute stroke and didnot meet the criteria for an acute strokeunit.

• The trust did not meet the guidance for allpatients with stroke to have imaging of thebrain within 24 hours.

• Even when care pathways existed, theywere not always used or used to besteffect.

• There was no facility for non-invasiveventilation on the respiratory ward.

• Some patients who needed non-invasiveventilation did not get it.

Findings of fact about aspects of careof medical patients, including thosewith stroke

Resuscitation

Resuscitation of patients who have suffered anarrest of the function of their heart or lungs isnot confined to medical patients but we haveincluded it here, since a higher proportion ofemergency admissions have medical problems.

At the meeting of the hospital managementboard in May 2005, it was reported that auditsof resuscitation trolleys sometimes hadworrying findings, with missing equipmentand drugs.

There was a serious untoward incident on theEAU in September 2006 that involved theaccidental infusion of lignocaine (a drug usedto suppress fast heart rhythms and for painrelief). This happened when trying toresuscitate an extremely ill patient. Thelignocaine should not have been on theresuscitation trolley.

The hospital management board in October2006 noted that the trust did not have anofficer for resuscitation. One was recruited inMay 2007. There was only one resuscitationofficer for the trust.

Problems with a lack of portable equipmentfor suction were identified at the medicaldivision governance meeting in July 2007. InFebruary 2008, the clinical quality andeffectiveness group noted that there was no oronly limited portable suction available forpatients who had suffered an arrest. The riskregister for the medical division in April 2008stated that there were no portable suctionmachines at the trust, as the existingequipment had been condemned, and thathandheld devices were to be introduced whiledifferent systems were reviewed. In May, itwas noted that funding had been foundthrough the capital programme, but thetimescale for provision was not specified.

The trust had four different types ofresuscitation trolley, rather than a singlestandardised type as is generally consideredpreferable.

We noted during our unannounced visit inFebruary 2008 that a resuscitation trolley onward 10 had not been checked since July

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Governance in the medical division

We have already considered specific issues todo with governance in A&E and theemergency assessment unit, both parts of themedical division, and considered complaintsand incidents.

From April 2007, there were monthly meetingsof the governance committee of the medicaldivision, chaired by the head of division. Thesewere generally well attended by consultants.Complaints and incidents were standing itemsat each meeting, but the amount of detailprovided was unclear. The discussion oncomplaints was around numbers and responsetimes, not the issues raised. The groupidentified clinical risks, many of which werethen put on the divisional or corporate riskregister. An example would be the monitors onthe acute coronary unit mentioned above. InJuly 2007, it appeared these had previouslybeen on the register and were to be reinstatedas risks. However, over a year later, thesituation had still not been resolved.

Similarly in October 2007, one of the top fiverisks on the register was the failure to deliveradequate and timely care to patients in A&E.In November 2007, the division had assessed

2007, was missing some items and containedsome medication and solutions that were outof date. The trust explained that this was notthe resuscitation trolley used on the ward.However, this could have been confusing,particularly to an agency nurse. The trust tookimmediate action to remove the trolley. Theother trolley, that was meant to be the one inuse, had not been checked for 10 days.Subsequently, we found that the checklists onthe trolleys were generally up to date.

The minutes of the clinical quality andeffectiveness group in July 2007 recorded thatthe bleep system for cardiac arrests was to beput on the risk register. It was noted that, ifthe system failed to work, there weredifficulties getting hold of the crash team andthere was no contingency plan. In a latermeeting, it was confirmed that this had beenadded to the risk register.

In September 2007, the clinical quality andeffectiveness group was informed that thecardiac arrest bleep system had failed on anumber of occasions at both Stafford andCannock Chase hospitals. As this was aclinical risk, a contingency plan of usingmobile phones was adopted.

In April 2008, the risk register for the medicaldivision recorded that the bleep system couldbe unreliable and had been temporarilyunavailable on a number of occasions. This“would result in the resuscitation team beingunaware of a cardiac arrest and so would beunable to respond”. The register noted that adaily resuscitation bleep test was performedby the switchboard staff and any problemswere reported to the resuscitation officer.

We were told by a junior doctor of an occasion,some months earlier, when the doctorreceived a bleep in the middle of the night tosay that a patient was not breathing. Thedoctor arrived on the ward about 10 minuteslater and was shocked to find that they werethe first person there. The nurse had notcalled in a crash team and the doctor wasconcerned that the nurse had not receivedproper training, since her first action shouldhave been to call the crash team.

• There had been a serious incident in 2006involving an inappropriate infusion on aresuscitation trolley.

• Our spot check on a ward in early 2008revealed a trolley that was out ofcommission but that had not beenchecked since July 2007 and containedsome items that were out of date.

• The malfunctioning of the bleep systemfor cardiac arrests was recorded on therisk register in 2007 and 2008. Theproblem continued and mobile phones hadto be used.

• There were problems with the availabilityof portable equipment for suction.

Findings of fact about resuscitation

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as serious the risk posed by the lack ofstaffing for the clinical decision unit in A&E.However, in May 2008, the situation was soworrying in A&E that we had to ask the chiefexecutive to take immediate action on this andrelated issues.

There were no meetings in the medicaldivision to discuss mortality and morbidity.There was an educational session on Fridayafternoons at which interesting cases or topicswere presented, but minutes were not taken.

Although there was evidence elsewhere in thedivision that audits had been performed, forexample relating to stroke, cancer, chronicobstructive pulmonary disease, cardiac andchest pain, we were told by many senior staffthat there was not an appropriate forum inwhich to discuss audit findings.

In July 2007, NICE produced guidance on themanagement of acutely ill patients. The trusthad not carried out any audits of performanceagainst the recommendations.

• The governance meetings for the divisionbegan in April 2007.

• There was little, if any, learning fromcomplaints and incidents.

• Problems were entered on the riskregister but not resolved in a timelyfashion.

• There were no records of meetings toreview mortality and morbidity.

Findings of fact on governance in themedical division

Patients admitted as emergencies withsurgical problems or traumatic injuriesWe have considered in the previous sectionpatients admitted as emergencies with acutemedical problems. A smaller proportion ofemergencies consist of patients taken tohospital with traumatic injuries or conditionsneeding emergency surgical operations.These patients are equally important andneed rapid, accurate diagnosis by experiencedstaff and speedy resolution of their problems.

We covered much of the relevant guidance inthe introductory section to the report.Guidance from the National ConfidentialEnquiry into Patient Outcomes and Deathsstates that there should be sufficient, fully-staffed, daytime theatre and recovery facilitiesto ensure that no patient requiring an urgentoperation waits for more than 24 hours onceready for surgery. This includes weekends.

Sources of evidence

• Interviews with staff past and present

• Interviews with patients and relatives

• Trust documents, including reports ofserious untoward incidents, operationalpolicies, theatre utilisation reports, auditresults and minutes of meetings

• External reports, for example a review bythe Royal College of Surgeons

• Statements provided by the trust

• Nursing skill mix review

• Guidance from the Royal College ofPhysicians

• Operational protocol on medical review offractured neck of femur (hip)

• Case notes and inquest reports

• Department of Health statistics and trustdata on surgical volume

The trust provides surgical services at bothCannock Chase Hospital and StaffordHospital. In 2003, elective orthopaedic surgerywas moved to Cannock Chase. Trauma and

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When the EAU opened, about half the nurseswho staffed it originally worked in surgery andthe other half worked in medicine. However,over time, the nurses on EAU predominantlyhad medical backgrounds and expertise.

There was a difference of opinion about thefrequency with which patients with traumaticinjuries spent a significant length of time onthe EAU. There is a reference earlier in thereport to an audit showing that 10% of thesepatients were admitted to the EAU. Thisresulted in unnecessary delays in patientsbeing admitted to the trauma ward.

We also noted in a previous section that therewere concerns about the standard ofobservations by nurses of patients on the EAU.

On occasions, surgical and trauma patientscould be moved from the EAU to the medicalwards. Staff, particularly in trauma andorthopaedics, considered that staff on non-surgical wards had little knowledge of surgicalconditions or serious injuries. Staff on non-surgical wards had less appreciation of whatwas needed in terms of providing care totrauma and orthopaedic patients. It was alsoreported that, when surgical patients were onnon-surgical wards, it was difficult to monitortheir care and implement pathways. Wardrounds could take a long time as the patientswere spread around the hospital.

There was particular concern about the periodwhen the reconfiguration of the surgical floorsmeant that the beds for patients withtraumatic injuries were located next to wards 6and 7. There were different accounts of howlong this 'boarding out' had lasted, rangingfrom six months to two years. It appeared thatthe service moved three or four times duringthe reconfiguration programme. The traumaservice finally moved to ward 3 in August 2007.

The area used for this temporary arrangementwas on occasion described by staff as a “noman's land”. When it was initially set up, therewas no ward station, no reception, no access tocomputer and no phone. Facilities such as thesluice and store room were located on theadjoining wards. The layout also meant thatthere were some beds that could not be

emergency surgical operations are performedat Stafford. Other surgical services provided atthe site include breast surgery, generalsurgery, colorectal surgery, vascular surgeryand day case surgery.

Protocols used in surgery

At the request of the trust, the Royal Collegeof Surgeons of England conducted a review ofthe general surgery service (specificallycolorectal surgery and laparoscopiccholecystectomy) in June 2007. The reportnoted that there were no departmentalprotocols on bowel preparation, use ofantibiotics and post-operative management.

We were also told by some nurses andmanagers that there were few agreedprotocols for the management of specificconditions. Care was not generally provided inline with protocols and individual consultantscould behave in an idiosyncratic way. A policyon introducing new clinical techniques hadbeen agreed in September 2007, but staff stillhad concerns that some new procedures insurgery had been introduced in an ad hoc way.

Others said that while protocols might exist forsome conditions or circumstances, staff wereoften not aware of their existence. An examplewas whether there was a protocol for reportingincidents if a patient was moved out of hours,contrary to NICE guidelines. Instead, staffrelied on what they had been told verbally.

Process of admission and location of surgicalpatients

Several members of staff told us that beforethe opening of the EAU in 2004, surgicalpatients would go directly to a surgical bed,cared for by surgical nurses, although theymight have had to wait for such a bed tobecome available. This changed so thatpatients subsequently had to go to the EAU.This and the reduction of trauma andorthopaedic beds from 36 to 22, meant thatthere were more surgical patients on medicalwards and that surgical patients often spent along time on EAU, often up to the actual timeof surgery.

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observed. Cleanliness was said to be a furtherconcern, as was the risk of infection due to theproximity of the toilets.

It was in this area that, in April 2007, a seriousuntoward incident occurred. The subsequentinvestigation report stated that “it was anunpleasant place to work and would be anunpleasant place to be a patient”. The reportalso pointed out that the staffing levels and theskill mix on the ward were poor, while thelevel of nursing input that the patientsrequired was high.

Several patients and relatives were concernedabout the lack of information in this area, thedifficulty in contacting doctors and the overallstandard of care.

As an example, a patient “was admittedovernight to a four-bed bay on ward 7, adjacentto the orthopaedic ward. She was nevertransferred to the orthopaedic ward, however,after four days she was moved to the otherwall in the bay, which was adjacent to theorthopaedic ward, but not in view of theorthopaedic nursing station. There wereseveral occasions where her friend had to calla nurse because the patient was hanging outof the bed or in a soiled bed or because of thelack of observations. Her friend challenged thenurses regarding the soiled bed and also aboutleaving soiled things for hours within two feetof her bed. It was agony for her to be changedand on one occasion a nurse made anunpleasant remark about her being difficult.Her friend was not confident that she hadadequate pain relief”.

Ward 7 was where patients with colorectal andvascular surgery were cared for. We observedthat it was a very busy ward, again with alayout that made nursing difficult. Bothcolorectal and vascular surgery are ‘heavy’specialties requiring specialty nursing skills.Two separate teams nursed these patients.

Surgical cover at night and at weekends

The resident surgical officer (RSO) out of hourscovered both general surgery andorthopaedics. This meant that the workload

was high and sufficient experience wasrequired to cover both. This was not always thecase for some of the junior doctors whoworked as the RSO on shifts. RSOs at nightoften had to take responsibility for completingtasks that were left over from the day, as wellas undertake the workload for the night. TheRSO not only had to admit as many as 15 to 20patients, they might have to go to theatre or becalled to A&E, and they had to provide back-upto the junior doctor covering all the surgicalwards. Out of normal hours, there was just onefoundation year one doctor (the most recentlyqualified) responsible for covering all thesurgical beds.

In trauma and orthopaedics, there was also aspecialist registrar on call, and these doctorslived in the hospital or nearby. For generalsurgery, however, there was no registrar after9pm, so the only other person on call was theconsultant. Although the consultants said theywere happy to be called, some of the doctorsin training admitted they had left somepatients to the morning rather than call theconsultant in the middle of the night. Oneconsultant also thought this was a concern.

Several members of staff told us that the RSOswere quite varied in the level of experiencethey had. Some had a lot of surgicalexperience, while others had not. For example,one RSO had only had four months of surgicalexperience as a foundation year trainee, themost junior level of doctor. Senior doctors inA&E were concerned that, when they needed asurgical opinion on a patient out of normalhours, they might get someone with limitedexperience. We identified through our reviewsof case notes that these situations occurred.

Short stay surgical unit

This unit, as its name suggests, was forpatients coming for planned operations thatneeded only a short stay. It was intended to beopen from Monday morning to 3pm onSaturday.

Several staff told us that the short stay unitoften remained open at the weekends and wasstaffed by bank staff during that time. Staff

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Time to operation

There is evidence to suggest that there hasbeen a steady increase nationally over the last10 years in waiting times for emergencysurgery. A longer wait is more harmful forsome conditions than others. For example, thenatural course of appendicitis is the rupture ofthe appendix and life threatening peritonitis.For other conditions, the risk may be lessimmediate but it is still worrying anduncomfortable for patients, and potentiallyharmful.

One of the most common emergenciesencountered, particularly among olderpatients, is that of a broken hip (morespecifically, a fractured neck of femur). Theguidance from the Royal College of Physiciansis that patients with this condition should havean operation to repair it within 24 hours. Onoccasions, this will not be possible becausethe patient has a medical condition, such as anabnormal heart rhythm, which must be treatedfirst. Delay in operation not only causesdiscomfort, but can lead to other problemssuch as chest infections and pressure injuries.

We heard from many staff that there wasconcern about delays in operations, especiallyfor trauma patients and, in particular, patientswith a fractured hip. The operational policy forthe theatres at Stafford Hospital noted that thetrauma theatre was operational every weekdayfrom 1pm to 5pm, except on Tuesdays when itran from 9am to 5pm. At the weekends, therewas no dedicated trauma list and all cases,trauma or otherwise, were put on theemergency theatre list.

There was no system to prioritise cases for theemergency theatre list at the weekend. Thismeant that trauma cases were often delayedfurther, as priority was given to generalsurgical or obstetric emergencies. We heard ofmany examples where patients with fracturedhips had their operations cancelled severaltimes. In some instances, this meant that theywere not operated on for three or four days.This was contrary to the guidance.

from wards 7 and 8 were expected to overseeor help out on the unit. This was not alwaysallowed for in the staff rota. One senior nursesaid that they have some medical patientsthere and that it was sometimes unsafe atweekends.

In February 2008, the surgical division drew tothe attention of the clinical quality andeffectiveness group their concerns about thestandards of care on the unit when it was openas an escalation area. They reported that itwas on their risk register.

The review of the nursing establishment foundthat the short stay unit had a gap of threewhole-time equivalents between theprofessional view and the fundedestablishment.

• There were few protocols in use insurgery.

• When on wards other than surgical ortrauma, patients with surgical conditionsand severe trauma were not always caredfor by nurses who understood theirconditions.

• For a considerable period of time, whenlocated between wards 6 and 7, theenvironment and management of patientswith traumatic injuries were notacceptable.

• Ward 7 had a difficult environment andlayout for the combination of colorectaland vascular patients cared for on thisward.

• There were concerns about the use of theshort stay unit as an overflow ward atweekends.

• There was inadequate medical cover forsurgical patients after 9pm.

Findings of fact on surgical protocolsand admissions, cover and the shortstay unit

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75Investigation into Mid Staffordshire NHS Foundation Trust

Figure 3 shows the results of an ongoing audit,conducted by the trust between March andJuly 2008, looking at the time taken forpatients with a broken neck of femur to go totheatre for their operation. The percentage ofpatients operated on within 24 hours was 56%on average. The target in the trust was 80% forpatients who were medically fit to be operatedon within 24 hours and 100% for all patientswithin 48 hours.

In February 2008, the trust's mortality groupreviewed two cases of patients with a fracturedneck of femur where the lack of emergencytheatre availability was considered to be acontributing factor to their deaths. There hadbeen a delay in surgery over the weekend. Thegroup wrote to the theatre user group andexplained that they had reviewed the deaths oftwo patients who were waiting for surgery. It

was the view of the mortality group that thiswas unacceptable and that appropriate theatreprovision over the weekend with appropriatestaffing was needed urgently.

In our review of cases, we also identified apatient who had died after a delay of threedays before they had an operation on theirfractured hip.

At the meeting of the mortality group in May2008, it was reported that surgery within 24hours of admission for fractured hip during theweek was being achieved but that there wereproblems at weekends. It was reported that86% of patients requiring surgery wereoperated on within 24 hours.

This issue had not been resolved during ourvisits in the summer of 2008 and wehighlighted our concerns to the trust.

25

20

15

10

5

0

Month

Num

ber

ofpa

tien

ts

Mar-08 Apr-08 May-08 Jun-08 Jul-08

No of patients admittedOperated on 24 hoursOperated on 48 hoursOperated on 48 hoursNot operated on

^^

^

Figure 3: Time to operations for patients with a fractured neck of femur (hip), March-July 2008

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Theatres

We noted several references in the minutes ofthe trust's board to inefficiency and under-utilisation of theatres. There had been anumber of reviews of theatres in recent years,including one report to the hospitalmanagement board in March 2006. The newtheatre manager provided a report to theprivate section of the board in August 2007,which was described as “disturbing”. It statedthat the establishment was too low, there wasa deficit in training and a high level ofsickness. There was a report on theatreutilisation in March 2008 by a consultancyfirm, which included a recommendation thatreports from the theatre should be amendedto include reasons for delays andcancellations, and what corrective action wasto be taken. The problems were still apparentduring our visits in the summer of 2008. Wehave already noted the lack of a process toprioritise emergency operations at weekends.This led to tense relationships and occasionalconfrontations.

Some staff told us that operations were notrealistically timed, with the likely time for theprocedure being underestimated or aninadequate time being allowed betweenoperations for giving anaesthetics etc. This ledto lists running late and sometimescancellations. Others, however, said that staffin theatre were inflexible and would not startan operation after 4pm in case it did not finishby 5pm.

We were also informed that problems on thewards with patients not being ready, or lackingan escort, contributed to late starting timesand inefficient use of theatre time.

We were told that the department had lackedstrong leadership and that there had been a highturnover of theatre managers, some leavingafter a short period. The department also hadhigh sickness rates. In June 2007, the rate ofsickness was noted to have reduced to 9%. Theminutes of the theatre users group in June 2008recorded levels of overall sickness of 9.9%,which were noted to be the lowest for two years.

We were also told by many staff that, whenpatients had to wait for their operations, oftenbeing scheduled and then cancelled, theirdrugs, fluids and food were stopped for longperiods. Sometimes a patient's operationmight be cancelled four days in a row, and theywould receive 'nil by mouth' for most of theday, four days running. We refer later in thisreport to a case where a patient did not havemedication for a heart condition for threeconsecutive days.

Another concern related to trauma patientswas the lack of regular input from an ortho-geriatrician. These are specialist consultantswho advise on the medical management ofolder patients who are awaiting, or have had,orthopaedic surgery.

The undated protocol for the medical review ofpatients with fractured hip identified thatpatients had a delayed 'patient journey' due tothe lack of medical management.

A senior trainee told us that this was the firsthospital they had worked in without daily inputfrom an ortho-geriatrician. The consultantsreported that they had been trying to get thematter resolved. One said that they alsoneeded more dedicated ortho-geriatric inputfor patients post-operatively. There had beenonly limited input from an ortho-geriatriciantwice a week, although the trust wasattempting to improve this.

• There was no system for prioritisingoperations for emergencies at weekends.

• Delays in operations were quitecommonplace, especially for traumapatients at weekends. In some cases, thedelays had contributed to poor outcomes.

• Between March and July 2008, an averageof 56% of patients with broken hips wereoperated on within 24 hours.

• There was little input and advice fromspecialist ortho-geriatricians.

Findings of fact on time to operation

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The data available about the use of theatreswere very poor and we could not reconcile thisinformation with, for example, that fromHospital Episode Statistics (HES). The trust hadpurchased a new system for recording suchdata but there were technical problems formany months, during which the systemreverted to recording on paper. Particulardifficulties were encountered when trying toestablish volumes of specified procedures foreach of the surgeons carrying them out. Anumber of routes were used to try and obtainthis information, specifically with regards tovascular procedures over the period from April2005 to the most recent information available.

Initial analysis of HES indicated some potentialerrors with regard to the surgeons recorded ascarrying out vascular procedures, the majority ofwhich would be expected to be by the trust’s twospecialist vascular consultants. The trust thensupplied their full surgical log, which containedinformation about which procedure was carriedout and the surgeon involved. However, this logappeared to be incomplete. For example, of 13procedures relating to the repair of abdominalaortic aneurysm that had been identified in HES,only four could be found in the surgical log. Wethen asked the trust’s information departmentwhether they could supply us with theinformation we required. Although theinformation was supplied, it was incomplete dueto the fact that the trust’s old ‘korner card’surgical log system involved the manual input ofinformation, including the patient identifier. Thisled to errors and an inability to link with otherinformation systems in the trust. Because thetrust’s data were poor, we could not undertakeanalysis of the volume of surgical work and itsoutcomes.

Observation of patients by staff andidentification of complications of surgery

Common complications of surgery includeinfection or bleeding or failure of ananastomosis, which is the join between twotubular structures. Surgery may also result inunintended internal injury, such as perforation ofpart of the bowel.

Although good surgical technique should reducethese events to a minimum, if they do occurearly recognition and intervention are essential.Deterioration in the patient’s condition isindicated by vital signs, which should beroutinely recorded. This happens by staffrecording frequent observations of certainimportant aspects of how the body functions,including heart rate, respiratory rate,temperature and blood pressure, and respondingappropriately to changes.

From our review of case notes and from thereports of inquests, there was evidence that staffon occasions failed to identify when patientswere deteriorating after an operation. We havenoted previously that 33 of the 51 inquests forwhich the trust provided summaries appeared toinvolve surgical patients, and many of theseinvolved complications of operations.

We have already identified that many wards inthe trust had low staffing levels. When wards areshort of staff, observations may not becompleted. We noted that not all nurses carriedout observations properly or with sufficientfrequency on the EAU or the medical wards.Some surgical patients were cared for on thesetypes of wards. Some staff expressed concernsthat patients who had colorectal surgery andthose who had vascular surgery were cared foron the same ward (ward 7). This ward wasdescribed as being very busy and nurses oftencould not attend ward rounds.

There had also been a shortfall generally in thetraining of nurses.

The review of the nursing establishment foundthat the shortfall of nurses in surgery was 30whole-time equivalents. Generally, the surgicalnurses were thought to be more skilled inidentifying patients whose condition wasdeteriorating. However, some of the doctors intraining were also worried about whether all thenurses on the surgical or trauma wards weregood at recording and responding toobservations. This included using the modifiedearly warning score (MEWS).

The lack of review of cases where complicationsoccurred meant there was little opportunity forsuch shortcomings to be identified and addressed.

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pulmonary embolism. Pulmonary embolismfollowing lower limb DVT is the cause of deathin 10% of patients who die in hospital, many ofthem after surgery.

At the meeting of the hospital managementboard in October 2005, it was noted thatanticoagulation was not robust in the trust. InApril 2006, the trust conducted an audit ofanticoagulation in acute surgical admissionsto determine whether it was prescribed andapplied properly according to surgicalguidelines. The results showed that 60% ofpatients did not have special stockingsaccording to the guidance and 17% of patientsdid not get the right drug.

We were told that, in April 2008, the trustdecided to follow NICE guidelines produced in2007 on preventing venous thromboembolism.However, some consultants told us that theprescribing of two of the main drugs forpreventing clots continued to be at variancewith the guidance for inpatients.

An audit of all inpatients started on warfarinfrom January to March 2008 (following theAnticoagulation Alert 18 from the NationalPatient Safety Agency) was presented at thesurgical governance meeting in September2008. It showed that an unacceptable numberof patients had not been treated according tothe protocol – only 10% of patients at CannockHospital and 30% at Stafford Hospital hadbeen treated appropriately. The audit alsofound that there were three differentanticoagulation prescription sheets in use inthe trust.

Relief of pain

Patients and relatives who came to see uswere concerned that, in many instances,patients had not been given timely oradequate relief for their pain.

One said: “After the operation, on ward 6, hewas in a lot of pain, but the nurse said heshould not be, as he had an epidural. He wasgiven paracetamol intravenously, althoughthis did not provide adequate pain relief.Apparently, morphine had been prescribed but

Some specific issues: anticoagulation and themanagement of pain

These issues are not solely confined tosurgical patients, but they are importantaspects in the care of patients havingoperations, so we consider them here.

Anticoagulation

Anticoagulation (also known asthromboprophylaxis) involves the prevention oflife threatening blood clots in the veins of thelegs and pelvis. When these clots dislodge,they are an extremely common cause of deathof patients in hospital and are largelypreventable. They are said to account forbetween 25,000 and 32,000 deaths in the UKevery year.

In 2007, the National Institute for Health andClinical Excellence reported that deep veinthrombosis (DVT) occurs in more than 20% ofsurgical patients and in more than 40% ofpatients undergoing major orthopaedicsurgery. Most of these thromboses are minor;the blood clot itself is not life threatening, andoften does not cause any symptoms. But if theblood clot comes loose, it can travel in thebloodstream to the lungs and cause a lifethreatening obstruction; this is called a

• There was a long history of concern aboutunder-utilisation of theatres.

• There had been several theatre managersbetween 2005 and 2008.

• There were high levels of sickness amongtheatre staff.

• There were concerns about the monitoringof patients whose clinical condition wasdeteriorating, especially on the EAU andthe medical wards.

• The data available on the use of theatresand surgical volume were very poor, andprevented us from undertaking furtheranalysis.

Findings of fact on theatres and onobservations of patients by staff

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was not given. Three days later, it was foundthe epidural was sited wrongly. At the inquest,it was also noted that he did not receiveadequate pain relief for the first three daysfollowing the operation and that morphinewas prescribed but not given.”

Another said: “Her mother was not on painrelief as far as she and her husband wereaware. They recall that she was sometimesscreaming with pain.”

We noted that, at the meeting of the clinicalgovernance group in November 2006, therewere two to four complaints a week aboutpoor control of pain.

It was difficult to establish if there was aspecialist service to advise ward staff on themanagement of pain. There had been previousrecommendations that such a service shouldbe developed and, at various times, a grouphad been set up to consider how to achievethis. One or two staff thought there was anacute nurse for pain, while a larger numbersaid that there was no dedicated nurse orspecialist team for pain. The trust informed usthat one of the advanced practitioners hadtaken on this role, that one of the consultantanaesthetists led on the management of pain,and that the critical care outreach team alsogave support.

There was also considerable confusion amongstaff as to whether there were protocols in thetrust for the assessment of pain and provisionof pain relief. Some staff said that there wereno such guidelines for the relief of post-operative pain. One nurse said that they hadprotocols on pain relief and pain scores, butthat an audit showed that the pain scoreswere not always filled in, although this wasimproving.

In January 2007, an audit was undertaken ontraining on the management of pain. The aimof the audit was to determine whether thesuggested standards for this training werebeing met. The standards of the Royal Collegeof Anaesthetists in 2006 were used as thebenchmark. The results were that thestandards were not met by either juniordoctors or nurses and that the trust was in

the same position as in the previous audit of 2003.

In June 2007, the clinical quality andeffectiveness group noted that little progresshad been made by the “pain group” inimproving the management of pain.

Several members of staff told us that lowlevels of staffing were an important factor indelayed relief of pain for patients. Some stafffelt that there were not enough people on theward who were competent in the assessmentand management of pain, and a lack of nurseson the wards to dispense it in a timelymanner. It was also said to vary with thenumber and mix of doctors on duty. Nursessaid it was often difficult to get junior doctorsto prescribe medication for pain relief atweekends, because of the scarcity of doctorsavailable.

Governance in the surgical division

Sources of evidence

• Interviews with staff past and present

• Trust documents including audits, andminutes of meetings

• In October 2005, the hospital managementboard noted that anticoagulation was notrobust in the trust.

• In September 2008, an audit found thatonly 30% of patients had been givenwarfarin in accordance with the trust’sprotocol.

• The clinical quality and effectivenessgroup learned in November 2006 thatthere were two to four complaints a weekabout the poor management of pain.

• An audit in 2007 found that there had beenno improvement in training on themanagement of pain.

Findings of fact on anticoagulation andthe management of pain

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The meetings that were often referred to as“audit meetings” in the surgical division weremeetings usually involving only medicalprofessionals. They were also referred to asthe mortality and morbidity meetings andincluded reviews of selected cases. Onoccasions, audits were presented. Themeetings were described as being “closeddoor” and informal. No minutes were takenand there was no systematic way for anyfindings or lessons to be incorporated in thedivisional governance or more widely in thetrust. The attendance by consultants at thesemeetings was described as poor. One traineetold us there had only been one of thesemeetings in orthopaedics within threemonths.

We noted one case of a patient with multiplecomplications following several operationsthat involved different surgical specialities. Aninquest had occurred, but this case had notbeen reported as an incident nor discussed inany formal hospital setting.

One of the alerts that the trust receivedrelated to cases coded as operations involvingthe jejunum. This alert was received in thesummer of 2007. In October 2007, four deathswere examined and the review concluded thatdeath was inevitable in each case. The reviewnoted that one patient, who had heartproblems, had been “nil by mouth” for threedays pending an operation and during thattime had received none of their usualmedication for their heart.

One of the two recommendations made wasthat the surgical division needed to review themanagement of medical problems in surgicalpatients who were nil-by mouth. This was tobe considered by the surgical clinicalgovernance group and reported back to thenext clinical quality and effectiveness group.

By March 2008, the surgical clinicalgovernance group had still not discussed thejejunal deaths and the recommendation, andno action had been taken. At that time, therewas no further report to the clinical qualityand effectiveness group. The deputy medicaldirector, a senior consultant surgeon, told us

• External reports, for example a review bythe Royal College of Surgeons

• Case notes and reviews of case notes

We have already noted the lack ofdepartmental protocols in general surgery.There was also no protocol on how toprioritise patients on the emergency operatinglist out of normal hours.

The trust was asked to provide a summary ofall clinical audits in the three-year period ofthe investigation. Of the 25 summariesprovided for the surgical division, 19 were newaudits and six were re-audits.

There were 11 audits that had a proposed re-audit date before January 2008. None of theproposed re-audits had been undertaken. Thisincluded audits on subjects such as theprevention of clots in the veins of the legs(anticoagulation) and the management ofpain. We have already noted that the finding ofan audit on the management of pain in 2007showed that they were in the sameunsatisfactory position as the previous audit in2003.

In 2005, an audit was undertaken onlaparoscopic cholecystectomies (an operationto remove the gall bladder using a smallincision and laparoscope) to compare thetrust's results against recently publishedresults. This was because there had beenconcerns about the outcomes of thisoperation. The audit suggested that the trust'sresults were comparable to the publisheddata. However, because of the small numberof operations, the conclusion was not robust.The audit summary stated that the trustneeded to continue with the audit to make itrobust. However, no further audit of theseoperations had been undertaken in thefollowing three years. This was despite areview by the Royal College of Surgeons in2007 making a recommendation on theimportance of audit in this area.

We received many comments from staff on theunsatisfactory state of audit in the surgicaldivision. There was no systematic approach toselecting audits and, for example, no auditshad been carried out on correct site surgery.

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that the forum in the surgical division thatcould have been used to discuss the jejunalreviews would have been the mortality andmorbidity meetings, but these meetings didnot necessarily discuss individual cases thatwarranted specific attention. At the end of2008, over a year after the problem wasidentified, the matter of ‘nil by mouth’ andmedication had not been resolvedsatisfactorily.

Two of our advisers reviewed these cases andconsidered that while the deaths may havebeen inevitable, there were other concernsthat should have been addressed. Theseincluded the lack of a timely review of thesepatients by a consultant. We noted earlier inthis report the importance of early assessmentby a senior doctor. Another involved theprevention of life threatening blood clots in theveins of the legs, which can be the cause offatal pulmonary emboli. This matter has alsobeen referred to earlier in this report.

The post of head of the division of surgery hadbeen held consecutively by two consultantanaesthetists and the clinical lead forgovernance in the division was also ananaesthetist.

We noted relatively poor attendance byconsultants at the meetings of the surgicalgovernance committee. For example therewere at least four meetings in 2008 where onlytwo consultants attended. There were twomeetings in 2007 where only one consultantwas present.

The trust requested a review by the RoyalCollege of Surgeons in 2007 because ofconcerns about aspects of surgical practice.The review noted that there were poorworking relationships and no cohesion in thedepartment of surgery. We were also told ininterviews, including by consultant generalsurgeons, that relationships were generallypoor among the general surgeons. The trusthad taken some steps to address this; but itwas too early to assess the success of thesemeasures. Little benefit had as yet beendemonstrated.

In addition to poor relationships between theconsultants, there was little evidence ofmultidisciplinary teamwork. The meetings toconsider mortality and morbidity were onlyattended by doctors. With regards to meetingsin the division, their focus had been onmortality and morbidity rather than audit, theywere not well attended or multi-disciplinary,and minutes were not taken.

We observed that, of the eight items on therisk register for surgery in April 2007, sevenwere still on the register a year later. Theitems included issues on staffing, finance,targets and capacity.

Provision of critical care (intensive care) beds

The critical care unit (CCU) had 12 beds: sixbeds for high dependency patients and six forthose needing intensive care. They were runflexibly depending on the needs of patients inthe unit.

• There were poor relationships betweenthe consultants in general surgery andlittle evidence of multidisciplinaryteamwork.

• There were no common managementprotocols in colorectal surgery.

• Re-audits had not been carried out, evenwhen recommended by the Royal College.

• Reviews of notes of patients who had diedwere not sufficiently rigorous, and failureswere not identified and rectified.

• Opportunities were missed to learn fromcases that had been the subject ofinquests. These included the lack of atimely review by a senior doctor.

• When concerns were raised, lessons werenot translated into action.

• There was no system in place to identifyfailure or to assure quality of care.

Findings of fact on governance insurgery

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There was concern from staff on the CCU that,if they accepted a patient on the highdependency unit before they transferredanother patient to a ward, the nurse to patientratio on the unit was reduced, which wasunsafe. If a patient had to wait in the EAU for abed on the CCU, this was when a decline inthe condition of the patient was likely to occur.

We were also informed that there wasfrequently a problem finding a bed on thegeneral wards in order to transfer a patientfrom the CCU. This sometimes meant thepatient stayed in the high dependency unitlonger than necessary, which in turn madeaccess to the high dependency unit difficult.

We noted from interviews and case notes thatrecord-keeping and multidisciplinaryteamwork were good on the unit. Patients andrelatives were also full of praise for the carereceived.

Some staff were also concerned about thecapacity of the general wards to care forpatients transferred from critical care. Thetrust had a team to provide outreach fromcritical care. The team consisted ofpredominantly critical care nurses, one full-time and two part-time. They provided aservice from 9am to 5pm from Monday toFriday. They advised and supported ward staffwho were concerned about a deterioratingpatient. They also followed up patients whohad been discharged from the CCU and theyprovided some formal and informal educationand training. The surgical nurses were said tobe more receptive to the outreach team,although acute medicine had a higher numberof patients requiring critical care support thansurgery.

The main concerns of the outreach team werethat observations were not being performedon the wards and the slow progress made withthe MEWS scores. Numerous incident formswere said to have been submitted about this.

Because there were usually only six staff onduty and 1:1 or 1:2 staffing was required forintensive care or high dependency patientsrespectively, this meant that the most numberof beds used was between six and eight.

The CCU had been funded for seven nursesper shift but, due to long-term sickness andredeployment, this dropped to six per shift.This applied for most of the period of thisinvestigation. In July 2008, extra funding wasallocated to recruit 5.5 whole-timeequivalents.

Some members of staff said that beds wereclosed or were unavailable because staffingnumbers were inadequate. Winter,particularly Christmas time, was reported tobe difficult.

A report from the surgical division to theclinical quality and effectiveness group inJanuary 2008 said that a high number ofcritical care patients had to be transferred toother units because of a lack of beds. Wewere also told about disagreements betweenclinicians about which patients could go to theunit, and about access to advice from medicalstaff in critical care. On one occasion, this hadresulted in a serious incident.

Many staff said that there was insufficientcapacity in the CCU, mainly because of lack ofstaff. When there was no bed available, verysick patients, such as ventilated patients,were on occasion taken from other wards tothe recovery area of theatres until a bed onthe CCU could be made available. In this area,the anaesthetist stayed with the patientbecause the recovery staff were not trained tolook after intensive care patients. This couldhave an effect on other operations performedout of normal hours. These patients couldcome from theatre, the EAU or A&E.

When this happened, the patient was usuallyin recovery for a few hours or overnight. If thiswas at the weekend or out of normal hours,then operating had to stop as the anaesthetistwas looking after the patients.

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• At times there were too few staff to open asufficient number of critical care beds.There was some confusion and tensionabout access to medical advice when bedswere not available.

• The critical care outreach team operatedfrom 9am to 5pm Monday to Friday.

• The critical care staff had noted a declinein standards of nursing care on the wardssince the reconfiguration and loss of staff.

• There had been occasions when very sickpatients were looked after in the recoveryarea by an anaesthetist until a CCU bedcould be made available. This had aneffect on operations out of normal hours.

Findings of fact on critical care

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We considered the control of infection, since itis an important aspect of the quality of care,and healthcare-associated infections can be asignificant cause of death of patients inhospital.

Sources of evidence

• Interviews with staff past and present

• Interviews with patients and relatives

• Data about rates of infection from theHealth Protection Agency

• Trust documents, including the infectioncontrol annual report, minutes of meetings,and data about rates of infection

• Complaints

The arrangements for the managementand accountability for infection controlIn December 2003, the report of the ChiefMedical Officer stated that every organisationproviding NHS services must designate adirector of infection prevention and control(DIPC). The guidance that followed said thatthe DIPC would have overall responsibility forcreating a culture in which effective hygiene isthe norm and infection control is everyone'sbusiness. The DIPC would report directly tothe chief executive and the trust's board.

The role of DIPC was first held by the previousdirector of nursing at the trust, who left in July2006. The newly appointed medical directortook over the role in September 2006. Therewas no reference to this appointment in theminutes of the trust's board, despite theimportance of the role. The new director ofnursing acquired the role in August 2007. Thenew management arrangements werepresented to the board, although not detailed

in the minutes. The rationale for the secondchange was that, nationally, infection controlwas being driven from the office of the ChiefNursing Officer and also because the infectioncontrol nursing team were coming to thedirector of nursing for professional guidance.

Since the director of nursing became the DIPCin August 2007, she had reported regularly tothe trust's board.

During 2006 and 2007, the infection controlteam consisted of two consultantmicrobiologists and two infection controlnurses. There had been some turnover, withthe two nurses leaving and being replaced in2007 by a matron and an experienced nurseundertaking training in infection control. Theteam met regularly, usually weekly.

We noted that, during 2005, the previous DIPCwas frequently absent from meetings of theinfection control committee. She explainedthat this was because she could not alwaysmake the meetings. She reported that she metregularly with the lead microbiologist. Theinfection control committee was scheduled tomeet every three months, but did not alwaysdo so.

In August 2007, the arrangements changed andthe steering group for infection prevention andcontrol was established. The chief executivechaired the new committee and it met monthly.It included a wider membership and had moremembers of the executive team and seniormanagement.

One of the responsibilities of the DIPC is toproduce an annual report on the state ofhealthcare-associated infection and release itpublicly. In most trusts, the mechanism for thisis to take the report to a public meeting of thetrust's board. There was no evidence that anannual report on infection control had ever beentaken to a public meeting of the board.

Healthcare-associated infections and thecontrol of infection

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The medical director provided us with a three-page annual report for 2005, but there was norecord of this being taken to the board. Therewas an eight-page report that covered theperiod January 2006 to March 2007. This wastaken to the board in July 2007, but only to theprivate, confidential part. Thus, for over twoyears, there was no public record of the stateof healthcare-associated infection at the trust.Towards the end of 2007, the trust began toshare information with the overview andscrutiny committee and trust governors andmembers. In 2008, the 40-page annual reportwas taken to the meeting of the board in April2008. This was not a public meeting. However,the report was placed on the trust's website.

Cleanliness and hygiene at the trustWe have already noted that patients andrelatives had very critical comments aboutcleanliness and hygiene. These concernsoccurred throughout the three years coveredby the investigation, but were particularlypronounced for the last few months of 2007.Here are some examples:

“Generally, the hospital was dirty. There wereballs of dust in the corners of rooms, hallwaysand on the stairs. They even saw blood in thelifts and a trail in the corridors. When leavingthe hospital hours later it was still there.Rubbish was stacked in the corridors, bothnormal and surgical waste.” (2006)

“And they witnessed a cleaner coming into theroom with a pink J-cloth, which she used towipe faeces off the bed frame. She thencleaned the table, the sink, their mother's dripstand and the cupboard next to the table withthe same cloth.” (2007)

“Their mother was moved into a side room. Itsmelt terrible and obviously had not beencleaned. Dirty washing was still in there on theen-suite, the bin was overflowing and the sinksmelt terrible. The dirty washing was still there24 hours later – they took it out. They didn'twash off her nighties before giving them to thefamily to wash. On one occasion, a cleaner justcame in and poured bleach down the sink. Onanother occasion, syringes were just left by the

sink. An empty tablet packet was on the floor.They left it to see if it would ever get clearedup; after a week it had not.” (2007)

At the meeting of the infection controlcommittee in October 2005, it was noted thatthe wards were struggling to meet the hygienestandards. In December, it was noted that“environmental cleanliness was not beingmaintained”.

The minutes of the meeting of the infectioncontrol team in January 2007 noted that acomplaint regarding a patient on ward 11 wasgoing to the local press. The complaint wasthought to be due to blood splashed on a wall,but the team noted it had also highlightedissues regarding standards of care on theward.

The minutes of the infection controlcommittee in December 2006 noted the needto replace damaged commodes and to improveisolation facilities. The report covering theperiod January 2006 to March 2007 stated thatthe audit of the kitchen, environment andequipment continued to highlight the ongoingissues related to cleaning. However, the reportstated some improvements had beendemonstrated during the audits that wereundertaken during this period.

The Healthcare Commission found the trust tobe compliant with regard to the hygiene codewhen it inspected the trust in January 2007. Atthis time, the check was mainly ofdocumentation.

An audit of commodes in August 2007 foundthat approximately 35 commodes neededreplacing. It was noted during the audit thatup to 50% of the commodes were soiled withfaeces. The audit noted that this highlighted atraining issue, which the company conductingthe audit would provide. The commodes werereplaced in December 2007 and a subsequentaudit in May 2008 found that 37 out of 46 wereclean.

In March 2008, the Department of Health teamfor cleaner hospitals noted improvementssince their visit in October 2007.

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When we visited the trust in February 2008, wefound that many of the wards and other areashad damaged floors and some were grubbyand stained. At that time, many parts of thehospital that we visited appeared scruffy. Onthe medical wards on floor two, every door toevery single room being used for isolation wasleft open.

During our subsequent visits, we found thatcleanliness and hygiene had improved.

Prescribing of antibioticsCareful consideration needs to be given whenprescribing antibiotics, for two main reasons.One is to prevent the unnecessary prescribingof these drugs and reduce the development ofresistance by bacteria. The other is to avoid,wherever possible, the types of antibioticswhich are particularly likely to put patients atrisk of developing C. difficile infection.

In December 2005, the Chief Medical Officerand Chief Nursing Officer wrote to all trustsasking them to review their policies forantibiotics. Many senior staff conceded thatchanges in the prescribing of antibiotics at thetrust had been protracted. We were told thatthere were discussions in different forums,such as the medical division and themedicines management group, but these wereslow to achieve change. Although policies hadbeen produced, these had not been adhered to.The protocol for managing antibiotics wasdated September 2007.

One of the reasons put forward for the slowprogress was resistance from the medicalprofessionals. Doctors in training and someother staff said that they were often told whichantibiotics to use by the consultants. They saidthat, in reality, it was the consultants whomade decisions on which antibiotics to use,and consultants sometimes deviated from theguidelines and used medications of personalpreference.

The pharmacists that we interviewed wereconcerned that there were too many policiesfor antibiotics and that the policies were noteasily accessible. They thought that you had to“hunt” for them and that generally they werenot being widely used.

One of the pharmacists had, as part of theirjob description, the role of antibioticpharmacist. Unlike many other trusts, therewas not a pharmacist dedicated to each ward.Staff mentioned that pharmacists checkedprescription sheets and had begun to deal withnon-compliance, that is those not prescribingin accordance with the guidelines. A juniordoctor, however, said that they had not hadany feedback on their prescribing, in contrast

• The trust had three DIPCs in just over ayear. The first did not regularly attend theinfection control committee.

• Patients and relatives who contacted uswere very critical of standards ofcleanliness and hygiene at the trust,particularly in 2006 and 2007.

• The trust was found to be compliant withthe hygiene code in January 2007.

• From August 2007, the chief executivechaired the steering group for infectionprevention and control. It had a largermembership and met more regularly.

• Although a requirement since 2004, therewas no public record of infection control atthe trust in the form of an annual reportuntil April 2008, when one was put on thetrust's website.

• The Department of Health team forcleaner hospitals noted improvements ininfection control between October 2007and March 2008.

• We observed an improvement incleanliness and infection control betweenFebruary and September 2008.

Findings of fact on infection controlarrangements at the trust

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to their previous post. We were told thatpharmacists could only help if they had extraresources so they could be involved on thewards.

We noted that, in September 2007, the surgicaldivision governance meeting learned thatdoctors in colorectal surgery had not compliedwith the policy for antibiotics and there hadbeen three cases of C. difficile in that month.In November 2007, the steering group oninfection control noted that the antibioticpolicy was still rated “red”. In April 2008, anaudit found that most intravenous antibioticswere being given according to the policy, but15.8% were not.

The trust’s own root cause analysis of cases ofC. difficile carried out in 2008 suggested thatantibiotics played a major part in predisposingpatients to this infection. The steering groupstrengthened the protocol and compliance hasimproved.

We were also told that it was not unusual forthere to be a delay in the administration ofantibiotics and for doses to be missed.

C. difficileClostridium difficile (C. difficile) is the majorcause of serious bacterial infectious diarrhoeaacquired in hospitals in the UK and is a veryunpleasant illness. The death rate associatedwith C. difficile infection has been estimated tobe 6.9% at 30 days after diagnosis.

The figures for 2005/06 show that, in January2006, there were 48 new cases of C. difficile atthe trust. The previous three months hadshown a consistent number in the high teens,with an average of 18.

It is evident there was a significant increase inthe rate of cases of C. difficile in the earlymonths of 2006. Figure 4 identifies this clearly.Such a rise is strongly suggestive of anoutbreak. At least some of these cases werecross-infection, where C. difficile wastransmitted from one patient to another. Therate stayed high in 2006 and it also appearsthat there was a smaller outbreak later in thatyear. Figures from the Health ProtectionAgency show that, in 2006, the trust had the

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Jul-Sep06

Oct-Dec06

Jan-Mar07

Apr-Jun07

Jul-Sep07

Oct-Dec07

Jan-Mar08

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Jul-Sep08

Figure 4: C. difficile rates at the trust per 1,000 bed days by quarter, January 2005-September 2008

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sixth highest rate out of 32 similar trusts.There had been a decline in the rates sincethe last three months of 2006.

The trust’s board minutes did not contain anyreference to C. difficile in any of the meetingsfrom 1 December 2005 to 8 August 2006.During this time, there was one reference toconcerns being raised about cleanliness in thehospital. When the report of the HealthcareCommission’s investigation into outbreaks ofC. difficile at Stoke Mandeville hospital, part ofBuckinghamshire Hospitals NHS trust waspublished in July 2006, the trust’s board didnot discuss the report.

There was evidence that the infection controlteam was aware of a sharp rise in cases, butthis was not described as an outbreak orreported as such. The meetings of the controlof infection committee were only quarterly. InMarch 2006, the minutes record that there wasan awareness of the rise in cases in January.The infection control team developed an actionplan and took steps to isolate patients,improve cleaning and control the prescriptionof antibiotics.

A surveillance report was compiled in thesummer of 2006, which stated that duringNovember and December 2005 there had been18 and 19 cases identified respectively. InJanuary 2006, this had risen to 48 “sporadiccases” being reported. It concluded that“analysis of surveillance data did not indicatean outbreak”. However, as the cases had notbeen typed (that is, categorised into specifictypes of C. difficile), this conclusion could notbe drawn. Even if none of the cases werelinked, an increase in cases of this proportionshould have been reported to the HealthProtection Agency, the SHA and the trust'sboard. At the meeting of the committee inMarch 2006, the representative from theHealth Protection Agency asked if outbreaksand ward closures were reported to the SHA.The previous DIPC replied in the affirmative,but neither had been reported.

The usual practice would be to establish anoutbreak committee, involving estates and

facilities as well as management and clinicalstaff. This did not happen. The surveillancereport found:

• Delays in sending samples for testing priorto C. difficile toxin being detected.

• Limited evidence of review of antibiotictherapy.

• Delay in commencing appropriatetreatment for patients that showedsymptoms.

• Poor documentation and communicationbetween nursing and medical staffregarding patients that showed symptoms.

• Poor communication with infection controlwhen patients' symptoms were notimproving.

• Patients not being nursed in isolation dueto lack of side rooms.

• Inadequate cleaning of commodes, bedpanholders and slipper pans between patients.

As we have noted, an action plan wasdeveloped and the microbiologists andinfection control nurses acted to instigate theisolation of infected patients and address theidentified problems. However, none of thedeficiencies in practice were drawn to theattention of the trust's board.

The 'annual' report of infection control thatcovered this period spanned from January2006 to April 2007. Therefore the 'outbreak'period was covered by an annual report over ayear later. The report did not go into detailbeyond mentioning the figures for C. difficileand noting that an action plan wasimplemented in March 2006. This report didnot use the word ‘outbreak’ or highlight theproblems that were found, and it was notreleased publicly.

A former member of the patient and publicinvolvement forum (PPIF) commented that itwas difficult to obtain information from thetrust on C. difficile. He felt this should be inthe public domain. He obtained a copy of theinfection control minutes for the meeting on

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21 September 2006, which recorded that therehad been 341 cases in total, of which 285 wereinpatients, averaging 36 per month betweenJanuary and September 2006. The minuteswere not marked as confidential. When thisinformation was released by him to anewspaper, he was expelled from the forumfor breaching the code of conduct of the PPIF.He told us that the chair of the trust met withthe chair of the PPIF and said that confidentialdocuments would not go to the PPIF anymore. The chair of the PPIF stated that,following this incident, matters of aconfidential nature were then given to him bythe trust’s chair for onwards transmission asdeemed necessary. These events were afterthe publication of the HealthcareCommission’s report into outbreaks of C.difficile at Stoke Mandeville Hospital, part ofBuckinghamshire Hospitals NHS trust, whichhad criticised that trust for lack of opennessabout outbreaks.

Over the summer of 2006, the committee forthe control of infection did not meet for sixmonths, despite continuing high levels ofinfection.

Since the end of 2006, the rates of infectionwith C. difficile declined steadily and by mid-2008 were lower than the average for similartrusts. However, the control of prescribing ofantibiotics proved difficult, as previouslyconsidered. Root cause analyses of cases of C.difficile in 2008 still showed some cases to beassociated with the prescription ofinappropriate antibiotics.

MRSADuring the timeframe of the investigation, thatis from April 2005, the rates for MRSA showedlarge fluctuations, with two peaks. One wasbetween July and September 2005 and theother between January and March 2007.

The trust missed its target for the agreedmaximum number of MRSA bacteraemias inboth 2006/07 and 2007/08. However, the ratehas shown a general decline since January 2007.

• Prescribing of antibiotics was notcompliant with good practice and therewere no regular audits of practice untilOctober 2007.

• There was an outbreak of C. difficile inearly 2006.

• An outbreak was not declared or reported,and an outbreak committee was notestablished. An action plan wasdeveloped. The trust's board was notinformed.

• A report by the trust at that time foundproblems with isolating infected patients,inadequate cleaning of commodes andbedpan holders, poor communicationbetween wards and infection control, anddelays in starting treatment.

• Since the end of 2006, rates of C. difficileand MRSA have declined.

Findings of fact on antibioticprescribing, C. difficile and MRSA

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This chapter looks at whether seniormanagers at the trust had arrangements inplace to reduce risk and protect the safety ofpatients, and the quality of thesearrangements. This is considered both ingeneral and with particular reference toemergency admissions.

The trust’s approach to nursing and tolevels of nursing staff We include this section since there isconsiderable evidence linking the number ofnurses to standards of care, particularly foremergency admissions.

Sources of evidence

• Interviews with staff past and present

• Interviews with patients and relatives

• The acute hospital portfolio reviews,2004/05

• Observations carried out by members ofthe investigation team

• Trust documents, including the businesscase for the surgical floor reconfigurationand performance reports

• Nursing skill mix review

• Complaints

• National level of absence due to sickness,provided by the Information Centre forHealth and Social Care

The previous director of nursing, who wasappointed in 1998 and left in July 2006, told usthat she had been committed to thedevelopment of nursing, and gave usexamples of training and programmes todevelop leadership among nurses. She

reported that there had been considerablesupport for the reorganisation of the wardsinto clinical floors. However, many staff toldus that nursing had not been valued as aprofession under the previous director ofnursing. We were told that many nurses andother clinical staff had been unhappy aboutthe clinical floors programme, but that theywere worried about expressing their views.Those who did raise concerns told us they hadbeen ignored. It was reported that nurses hadbecome too demoralised to protest.

Staff felt that the position of nursing hadimproved since the arrival of the new directorof nursing in December 2006. They felt thatnursing had a voice, that the number ofnurses had begun to increase and thattraining was improving.

Staffing levelsIn January 2002, a review of clinicalgovernance at the trust was published by theHealthcare Commission’s predecessor, theCommission for Health Improvement. Itpointed out that staffing levels were a causefor concern, particularly in nursing, and thatthe number of nurses was low compared toother similar hospitals.

The report from the acute hospital portfolioreview in 2004/05 showed a mixed picture onoverall staffing levels in wards. There weresome wards (11 in total) with fewer staff thanthe average and some with more (five in total).This was also the case for the percentage ofqualified staff in post. There were also afurther eight wards with incomplete data.

As we have seen earlier, the acute hospitalportfolio report on ward staffing in July 2005noted that the trust was the worst of five localtrusts in terms of perceptions of nursing care.

Factors at a strategic level to reduce risk andprotect the safety of patients

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It was the second worst for complaints aboutnursing care per 10,000 occupied bed days,out of 24 small acute trusts outside London.

We also noted that there was informationavailable within the trust in 2006 and 2007 thatsuggested continuing concerns about nursingcare. This has been covered elsewhere in thereport.

We observed that, between April 2004 and May2008, the number of nursing staff in post hadnever reached the number of posts in thefunded establishment.

The trust had embarked upon a programme toreconfigure its clinical services when theprevious director of nursing took up post in1998. She described an innovative trainingprogramme for nurses to support thechanges. An important step was theestablishment of the emergency assessmentunit in September 2004. The next stage, in2005 and 2006, was to replace the individualmedical and surgical wards with 'clinicalfloors'. This was a view of nursing taken fromthe United States and supported by theprevious director of nursing. She viewedtraditional wards as being expensive becauseof duplication of roles, and unnecessarilyhierarchical.

She told us that the reconfiguration wasprimarily to improve the experience ofpatients and ensure that staff focused on theplanning and delivery of patient care, ratherthan on duplicating structures andadministration. She said that it was notrelated to the generation of financial savings.However, the minutes of the confidentialmeeting of the board in August 2005 referredto a saving of £700,000 from thereconfiguration. This related mainly to theclosure of a ward at Cannock Hospital. Wenoted that one of the benefits listed in thepresentation in January 2006 of the businesscase for the surgical floor was savings ofnearly £600,000, and savings were noted ofover £300,000 for the medical division.

Part of the reconfiguration programmeinvolved a significant loss of beds. Although areduction in staff was said not to be part of the

original intention, it involved a change in skillmix. The programme was meant to involverecruiting more healthcare support workers,and some of the healthcare support workersreceived extra training, particularly between2002 and 2004. Another element was thereduction in the number of qualified staff,especially on the medical wards, andparticularly a 60% reduction in the number ofsenior sisters. The previous director ofnursing stressed that this was not herintention or responsibility and did not happenduring her tenure. She left in July 2006.

It appears that, whatever the original intentionof the clinical floors programme, it becameinseparable from the programme to makefinancial savings. The net result was areduction in numbers of nurses, and a dilutionof the skill mix because of the loss of seniorposts and qualified nurses. Throughout theperiod of the investigation up to at least theend of March 2008, there were only threematrons for the entire trust, when more mighthave been expected for a trust of this size. Aswe note in the section on developments, thereare now 12.

We noted that vacancy levels had beenconsistently high at the trust. In the trust'srisk register report for 2002-2006, there wasan entry from March 2005 about the generalhigh level of vacancies. We noted severalreferences to high vacancy levels in theminutes of the trust's board throughout 2006and 2007, but saw little evidence that thepossible risks of this situation wereconsidered by the board. For example, inAugust 2005 there were 108 vacancies innursing. In January 2007, there were 86 totalvacancies, and in September 2007, 104.

The minutes of the trust’s board also madefrequent references to the high levels of staffsickness. In 2007/08, the rate varied between5.44% and 6.04%. In 2004, the national level ofabsence from sickness was 4.6% across alltrusts in England and 4.4% across acutetrusts in England.

In 2006/07, the trust was in the position ofhaving to make significant savings, like most

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of the NHS that year. The trust has said it hadto set a target of saving £10 million in order toachieve financial balance. This equated toabout 8% of turnover. Since its largestexpenditure was on staff, the trust decidedthat a significant proportion of the savingswould have to come from reducing thenumber of people employed by the trust. Theminutes of the trust's board and the hospitalmanagement board show the proposal was tolose 150 to 170 posts, two-thirds of them to befrom non-clinical staff, such as those infacilities.

We noted from the figures for staff in post thatthe largest reduction in the number of nursesoccurred between April 2006 and April 2007.The reduction of staff in post in that 12-monthperiod was nearly 130 whole-time equivalentnurses. In four years, the figure declined from2,359 in April 2004, to 2,318 in 2005 and 2006,2,189 in 2007 and 2,157 in 2008. By April 2008,there had not yet been any increase in thenumber of staff actually in post, althoughrecruitment had begun.

Between the years 2005 and 2008, there was areduction in beds as well as in nurses. Therewere 101 fewer beds and 297 fewer nurses(healthcare support workers as well asqualified nurses). When analysed as thenumber of nurses per beds, this represents adrop from 2.95 nurses per bed at the end ofMarch 2006 to 2.44 nurses per bed by the endof March 2008. This figure includes allhealthcare support workers and nurses,including managers and matrons. In otherwords, it is not the physical number of nursesper bed but an indication of the nursingworkforce compared to the beds available.This analysis does not take into account anychange in the dependency of patients,although this was unlikely to have decreased.

We have previously noted that there was onlyone band seven nurse for the 78 beds on floortwo, one for A&E, and only three matrons forthe entire trust.

Although problems about the standards ofcare were evident through reports oncomplaints in early 2007, the trust did not take

any action to increase the number of nurses in2007/08. In February 2007, the minutes of theboard stated that the “improvement in thenumbers would continue”.

At the meeting of the governance executivegroup in March 2007, the group received areport that showed that there had been 40formal complaints in February, compared with14 in January. The main categories related tobasic nursing care. However, the onlydiscussion reflected in the minutes related toresponse times to complaints, not about thepoor standards of care raised by thecomplaints. This meeting commented on theresult in the national patients survey thatshowed the trust did not perform well oncleanliness. But the minutes did not mentionthat the survey also showed the trust toperform poorly on the question about therebeing enough nurses to provide care.

Also in March 2007, the clinical quality andeffectiveness group received a report from themedical division that there had only been twonurses on floor two to look after 40 patients.

A senior consultant told us that staff in criticalcare had observed changes in the quality ofcare on the wards at this time, due to thereduction in the number and levels ofexperience of nurses. He had made his viewsknown through correspondence with directorsand heads of departments.

In May 2007, the private part of the trust'sboard noted that the trust had scored badly inthe national NHS staff survey. In particular,only 27% staff said they would be happy withthe standard of care provided as a patient.

In response to a complaint about nursing carethat it had investigated, the complaintsdepartment of the Healthcare Commissionwrote to the chief executive in July 2007. Theletter recommended that the trust consideredreviewing the nursing establishment and skillmix to ensure the staffing levels wereadequate for the workload and patientdependencies. At this time, the review of skillmix had already been commissioned by thenew director of nursing.

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The report on incidents that went to theclinical quality and effectiveness group inDecember 2007 showed that there had been 93incidents reported about staffing levelsbetween July and September 2007 and thefigures for October and November weresimilar.

The need for a review of the skill mix andnumbers of the workforce was included in thebusiness plan for 2006/07, to be completed byNovember 2006. The trust has now told us thatthis was a wider review of skill mix related tothe reduction of the workforce. When the newdirector of nursing took up her post inDecember 2006, she identified that it wasimportant to ensure a thorough andindependent review of the nursingestablishment and skill mix. This was in thebusiness plan for 2007/08 and was carried outbetween August and December 2007. It wasconducted by a nurse acting as an independentadviser to the trust.

The results were taken to the meeting of theboard of directors in March 2008. The reviewfound an overall deficit of 120 whole-timeequivalents. The surgical division had a staffinggap of 30.3 whole-time equivalents, while inthe medical division the gap was 76.8 whole-time equivalents.

The review also noted that there was a need toreduce sickness levels and to slow downturnover to ensure staffing levels weremaintained. The review proposed a £1.7 millioninvestment in the nursing workforce.Recruitment began in January 2008.

In the interim, before the review wascompleted, a 'virtual ward' was set up inOctober 2007. It consisted of seven whole-timeequivalent nurses, managed by the corporatenursing team. The nurses were not newlyqualified and could be moved to wherevernecessary, or slotted into vacancies on wardsso that they could be used instead of agencystaff. Nurses that we spoke to did not mentionthis as having made a significant difference tostaffing problems at that time.

At the meeting of the board of directors inMarch 2008, a question was asked as to

whether the board had been right to reducethe number of nurses at the time of thereduction of the workforce. The response wasthat they did not believe that the £10 millionhad had a big effect on what was an historicissue. The board noted that difficulties hadarisen due to the combination of turnover,sickness and difficulty in recruiting, and askedthat more focus be given to the speed ofrecruitment. The board approved an increasefrom three to 12 matrons and they have saidthey also approved a senior nurse for wards 11and 12, to allow closer monitoring of thestandards of care and improved leadership atward level.

• In 2002, the review of clinical governanceby the Commission for HealthImprovement pointed out that the numberof nurses was low compared with othersimilar hospitals.

• In 2005, the trust had more wards withbelow the national average number ofnurses than wards with above theaverage, by almost two to one.

• The combination of the programme tocreate clinical floors and the cost savingprogramme in 2006/07 led to a reductionin the number of nurses in post, and theproportion of senior nurses.

• Vacancy and sickness levels were highfrom 2005 to 2008.

• Although there was evidence early in 2007about the effect of low staffing levels, thetrust did not act to increase the number ofnurses in 2007/08.

• A review of the nursing establishment andskill mix was undertaken in the autumn of2007.

• The review found a shortfall of 120 whole-time equivalent nursing posts.

• In March 2008, the trust agreed to invest£1.7 million in the nursing workforce.

Findings of fact about the trust'sapproach to levels of nursing staff

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The trust's arrangements for managing riskAlthough our main focus was on the care ofpatients admitted as emergencies, we alsoreviewed the trust's systems for themanagement of clinical risk. These shouldallow trusts to identify potential risks and taketimely action to prevent harm. Members of thetrust's board should be aware of anysignificant risks to the safety and wellbeing ofpatients and take action accordingly to managethe risks.

A risk register is a way for trusts to record andgrade risks in terms of their seriousness.

At the meeting of the hospital managementboard in July 2006, it was noted that nothingwas being recorded on the risk register. Staffalso told us that the register had beeninadequate, out of date and rarely used, beforethe summer of 2006.

We reviewed the trust's risk registers as theystood at the end of March 2006, 2007 and 2008.The earliest version covered a period from2002 to October 2006; relatively it containedfewer entries and was of a different style, withdifferent details from later registers.

The 2007 and 2008 registers contained someentries that correlated with the issues that arepart of this investigation. For example, the2007 register contained an entry regarding theinability to ensure that there were safe levelsof staff in clinical areas during workforcereconfiguration, leading to a potentialreduction in the quality of care.

The 2008 register contained more entries,including:

• “The cost improvement programme leadingto a shortfall of staff on EAU which the bankcannot fill. Has led to complaints andcompromising patient safety and possibilityof serious untoward incidents reoccurring.”

• “Inability to meet NICE guidance forpatients needing non-invasive ventilationdue to lack of suitably trained staff.”

• “There are no portable suction machinesavailable across the trust as the existingequipment was condemned.”

• “Failure to deliver adequate and timely careto patients in A&E that need surgical ororthopaedic interventions due to reducedsurgical cover.”

From the different versions of the registersthat were supplied to us and from what wewere told by staff, it was evident that there hadbeen a move to produce and review riskregisters in the divisions in the trust. However,the head of governance told us that this wasstill not fully embedded within the divisions.We have previously noted the existence ofcertain items on divisional risk registers fromone year to another. We had some concernsabout whether the divisions had been expectedto resolve problems that were partly trust-widein nature, such as poor staffing levels.

A trust-wide panel to moderate risk wasintroduced to review and ensure consistency inthe scoring of risks. Any risk with a score ofmore than 15 was added to the corporate riskregister that was considered by the executivegovernance group and the board.

The trust supplied us with information aboutwhat the divisions had considered were therisks of the reduction in the workforce in2006/07. We could not find any evidence thatthe trust had at a corporate level consideredthese risks.

Assurance frameworkIn March 2003, the Department of Healthissued guidance on how to construct anassurance framework. Its purpose is to identifythe principal risks to the achievement of theorganisation’s objectives and to identify the keycontrols to reduce these risks.

Internal audit informed the trust board in July2006 that the framework had not been updatedthe previous year and that there had not beena regular flow of assurances to the board.There were weaknesses in design, and theinconsistent application of controls had put the

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achievement of the organisation’s objectives atrisk. A new framework that was devisedfollowing advice from the internal auditors andinput from executives was presented to theboard. It had 10 key objectives: the first was toachieve financial balance, the second was toachieve the required quality of care and thethird related to acquiring foundation truststatus. The trust has subsequently said that theobjectives were not ranked in order of priority.

In March 2007, the trust’s board waspresented with a framework for 2007/08. Thishad the achievement of quality of carestandards as the first key objective; achievingfinancial balance and foundation trust statuswere the penultimate and last (of 10)objectives.

The framework for 2008/09 was presented tothe board in March 2008. This was organiseddifferently to previous years, being groupedunder six strategic goals. The first of theserelated to being the provider of choice foracute services and included objectives toimplement the outcome of the establishmentskill mix review, achieve divisional costimprovement targets and improve data codingso to recover all income.

The head of governance told us that theaspects of the assurance process that relatedto the management of risks originally had notbeen fully integrated with the other aspects ofgovernance for which she was responsible,but had recently been brought together underthe director of nursing.

Systems to investigate and learn fromcomplaints

Sources of evidence

• Interviews with patients and relatives

• Interviews with staff past and present

• Complaints

• The acute hospital portfolio reviews,2004/05

• Information and analysis of second stagecomplaints

• Report of the internal auditors oncomplaints

• Trust documents, including minutes ofmeetings

In July 2005, the Healthcare Commission'sacute hospital portfolio review on wardstaffing in 2004/05 compared the trust withfive other trusts in the local area. It identifiedthe trust as being the worst for perceptions ofnursing care for adult patients. It was also theworst for complaints about nursing care per10,000 occupied bed days.

At the national level, the trust was the 17thworst in the country with a rate of 11complaints about nursing per 10,000 beds.The most typical (median number) was 3.88.In terms of its peer group of 24 small acutetrusts outside London, the trust was secondworst.

Until mid-2005, the trust had a committee toreview individual complaints, chaired by anon-executive director. This reviewedcomplaints on a quarterly basis and met withthe divisions. It was described as timeconsuming, but it ensured that non-executiveswere well informed about the nature andseriousness of complaints. At that time, therewere concerns about the medical wards, manyabout basic nursing care.

We requested copies of the trust's analysis ofcomplaints and reports on complaints for thethree years 2005 to 2008. We did not receive acomplete set for 2006, as there were noreports produced for some of that period. Welooked at the internal reports on complaintsand found that some of these were inaccurate.For example, the attachment for January toMarch 2006 in the complaints section of theclinical governance report was the samedocument with the same information as forOctober to December 2005. The table in thecomplaints report for July to September 2007was headed comparisons between quarterone and quarter four, but was actually acomparison of quarters one and two. Thecolumns themselves were headed correctly.This error was repeated in the next quarter.

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We noted that the graphical representation ofreports sometimes did not allow importantinformation to be easily identified. Forexample, the annual report on complaints for2006/07 showed a decline of 7% in overallcomplaints. However, there had been a rise incomplaints about inpatients (from 187 to 218),but this was masked by the substantial declinein complaints about outpatients.

Moreover, the breakdown of complaints wasvery limited, with 227 complaints identifiedsimply as “all aspects of clinical care”. Thiswas the same type of analysis as wasundertaken in many trusts, but was not insufficient depth to identify specific problems.Even when there was sub-categorisation, itwas not possible to determine the seriousnessof complaints. Thus, the trust's board wouldnot have had adequate information on which toassess the standards of care. We noted that,after the demise of the complaints reviewcommittee in 2005, non-executive directorshad never looked at any individual complaintsto get an indication of their nature. Again, thiswas not unusual. The minutes of the privatemeeting of the trust’s board in April 2007 saidthat the executive governance group wouldlook at the details of complaints, but this didnot happen in respect of any consideration ofactual complaints.

The analysis changed in later reports to includemore categories. However, the categories werestill very broad. The category ofcommunication, for example, could range fromminor failures of communication to seriousconcerns. Such broad categories restricted theusefulness of complaints as a means to learnabout possible shortfalls in services.

We have noted that at the meeting of thegovernance executive group in March 2007, thegroup concentrated on the response times, noton the poor standards of care raised by thecomplaints. This meeting also commented onthe result in the national patients survey thatshowed the trust did not perform well oncleanliness. But the minutes did not mentionthat the survey also showed the trust toperform poorly with respect to there beingenough nurses to provide care.

Handling of complaints and learninglessonsAs part of the plan for internal audit in2006/07, the trust asked its internal auditorsto review the way complaints were dealt with.The report was produced in January 2008. Theauditors were concerned that not all staff whoconducted investigations into complaints hadbeen trained in how to investigate. Neither hadall staff involved in complaints attendedtraining on report writing. Staff told us thatminor incidents and complaints were dealtwith at ward level and that the quality ofinvestigation and feedback depended upon theparticular nurse concerned.

The auditors noted that complaints were notassessed in terms of their seriousness in linewith the policy for the management of risk.They also noted that recommendations andaction plans arising from complaints were notclearly logged and monitored.

Responsibility for responding to the issuesraised through complaints had been devolvedto the divisions in January 2007, but there waslittle evidence that this had resulted in change.Managers told us that incidents andcomplaints were reviewed and discussed atdirectorate meetings, with learning and actionpoints being generated. Our analysissuggested, however, that in respect ofcomplaints only numbers and response timeswere considered. Most frontline staff seemedunaware of both action plans and subsequentactions. They reported a lack of learning fromcomplaints and incidents. They were unawareof any reflection on patterns or any formalsystem to ensure that action plans followingcomplaints were translated into action.

Patients and relatives who came to see usprovided evidence that this was indeed thecase. They brought action plans that had beensent to them in response to a complaint butwhere it was apparent that the same problemhad occurred again, well beyond the dategiven by the trust for the action to have beencompleted.

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Many patients and relatives who came to seeus were unhappy with the response tocomplaints. We were contacted by more than100 people and 38 raised their dissatisfactionwith the complaints process. No one in thisgroup was happy with the response theyreceived.

They considered that their concerns hadfrequently not been dealt with properly or thatthey were being “fobbed off”. For example,they were sent copies of policies, but in theirexperience the policy had not been followed,and the trust had not recognised this. Severalbrought the trust's response with them andwe could see that some were incomplete;others were poorly written with sentencesrepeated. In one, it was claimed that “withregard to the general modes of spread of theorganism Clostridium Difficile, it is veryuncommon for Clostridium Difficile to bepassed from one patient to another”. It addedthat “direct patient-to-patient transmissionappears rare but certainly transmission canoccur from infected surfaces”. In our view, thefirst statement is potentially confusing since C.difficile is easily transferred between patients,albeit via contaminated commodes, sharedequipment or utensils and infected surfaces.

In 2004, the Healthcare Commission becameresponsible for reviewing NHS complaints thathad not been resolved locally. We analysedreferrals for three years from April 2005 toMarch 2008 for the group of small acute trustsoutside London and found that the averagenumber of complaints referred to theCommission was 31.6, with a range of 12 to64. The trust had 64 referrals and was thehighest in this category. This suggests thatthere was greater dissatisfaction with howcomplaints had been handled than in othercomparable trusts.

Systems to learn from incidents Staff are required to report incidents wheresomething has gone wrong, or could havegone wrong, with the care of patients. Theanalysis of such incidents should lead tolessons being learned and the risk to patientsin future being reduced.

Sources of evidence

• Interviews with staff past and present

• Healthcare Commission NHS staff surveys

• Trust documents, including reports ofserious untoward incidents and minutes ofmeetings

In the national survey of NHS staff undertakenin 2007 by the Healthcare Commission, staffwere asked about the fairness andeffectiveness of procedures for reportingerrors, near misses and incidents. They were

• In 2005, the trust had the second highestrate of complaints about nursing care inthe group of small trusts outside London.

• Not all staff undertaking investigation ofcomplaints had been trained to do so.

• In line with much of the NHS, the analysisof complaints was limited in scope; therewas no indication of the seriousness ofcomplaints.

• Of the 103 patients and relatives whocontacted the Healthcare Commission, 38were dissatisfied with the response whenthey complained and no one in this groupwas happy with the response received.

• The trust had the highest number ofreferrals to the second stage complaintsprocedure of small acute trusts outsideLondon.

• There had been no system to ensure thataction plans translated into action, andconsiderable evidence that they did not.

Findings of fact about complaints

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asked whether staff who reported incidentswere treated fairly, whether the trust tookeffective action to prevent the incidenthappening again and whether staff receivedfeedback. The trust came in the worst 20% inthe response to these questions, and theirresult had deteriorated since the survey in2006. The trust was also in the worst (that is,highest) 20% on the percentage of staffwitnessing errors, near misses and incidents.

In other words, staff reported that theywitnessed a high level of errors but had littleconfidence that anything would be done aboutthem. There was no evidence that this hadbeen drawn to the attention of the board orthat the trust had taken any action in responseto these findings.

Most staff that we asked told us that whenthey reported incidents they did not getfeedback and there was little confidence thatthis led to change.

We noted there had been many incidentsrelated to staffing. For example, the trust wasasked to supply any records and details ofstaff concerns about nursing staff working onwards 10, 11 and 12 in relation to patient care.They provided us with 515 of these coveringthe period from April 2005 to August 2008. Ofthese, 191 (37%) related to staffing. Thesewere wards about which there was alsoconcern about standards of care from patientsand relatives. We have noted that 93 incidentswere reported about staffing shortagesgenerally in the trust between July and August2007. These had not been drawn to theattention of the board.

Reports on incidents were produced for thevarious committees concerned withgovernance. Since June 2007, this had beenthe clinical quality and effectiveness group andthe executive governance group.

We noted that the reports on incidents thatwent to the clinical quality and effectivenessgroup in July 2007 contained some veryspecific information on types of incidents,including violations of clinical guidance,omission of treatment and surgicalcomplications. However, the report to the

executive governance group in the samemonth had categorised the same incidentsdifferently, presenting a more anodyne pictureof problems that were categorised as“admission, transfer and discharge”. Therewas no reference to the specific nature of theincidents, such as complications of surgery.

Two non-executive directors attended theexecutive governance group. The trustsubsequently explained to us that theexecutive group received less specific detail asit considered all incidents, not just clinicalones. There was no evidence that any of theissues had been identified and generatedaction. In subsequent reports to the clinicalquality and effectiveness group, much of theclinical detail and significance was no longerprovided there either, and less informativecategories were used.

Responsibility for responding to the issuesraised by incidents had been devolved to thedivisions, but there was little evidence thatthis had resulted in change. For example,although summaries of incidents that went tothe clinical quality and effectiveness groupmight identify problems in surgery, as in theparagraph above, usually there would be nosign of these being discussed at thegovernance meeting of the surgical division.This was despite the assertion that it was theresponsibility of the divisions to resolve theproblems.

The online reporting system had beenintroduced in April 2007 because of a poorpaper-based system. However, many staff whowe interviewed reported difficulties with theonline system. These included the fact that itwas online, was not user friendly, was difficultto classify incidents in the specified categoriesand was too time consuming. This reduced thelikelihood of staff using the system.

Many senior staff acknowledged that the trusthad not been good at learning lessons andmaking changes to avoid repetition ofproblems.

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Serious untoward incidents

Serious incidents for non-foundation trustshave to be reported to their strategic healthauthority (SHA) and those affecting the safetyof patients have to be reported to the NationalPatient Safety Agency.

The trust defined serious untoward incidentsin accordance with the expectations ofsuccessive SHAs. This meant, from 2007, fullreporting of instances of healthcare-associated infection and reporting of otherincidents liable to result in adverse publicity.However, it did not mean that all seriousclinical incidents were reported. The trustappeared to have reported relatively few, otherthan for healthcare-associated infection.

We asked for all the serious untowardincidents that had been reported by the trust.We noted a number of cases, for example, thathad been the subject of inquests that shouldhave been reported and investigated asserious untoward incidents. The inquestscovered such issues as deaths associated withcomplications of surgery, missed fractures ofthe spine and two cases of ruptured spleen. Apatient wrongly given penicillin in August 2007was not reported. This patient died, but thehospital summary for the inquest stated thatthe penicillin did not cause the death.

Some investigations had been conducted bythe trust's solicitor and these were generallycomprehensive in nature. However, there wasno evidence of a robust mechanism to ensurethat the recommendations were followed.

There were also two incidents involvingpatients who absconded since April 2005. InSeptember 2005, a patient on the emergencyassessment unit jumped from a first floorwindow and was badly hurt. The patient wasbeing treated for alcohol withdrawal and wasagitated and aggressive. Prior to his incident,he was attempting to help restrain anotherdisruptive patient. The report into the incidentdid not comment on the levels of nursing staffon the ward at the time but noted the lack of asecurity officer. The trust relied on porters forsecurity. Staff on the unit were unaware of theprotocol for alcohol withdrawal, and the policy

for missing persons was out of date andinappropriate. The report also noted confusionabout contacting various organisations in theevent of a serious incident.

In October 2007, a patient disappeared fromward 11 and was found dead five days laterabout half a mile away in the grounds of StGeorge’s Hospital (part of a different trust). Theinvestigation report found poor communicationand handovers between medical and nursingstaff. It also found poor history taking anddocumentation. Staff were not aware of thepolicy for missing persons, despite theprevious incident. They were also unaware ofhow to assess and monitor vulnerable patients.This case was discussed by the clinical qualityand effectiveness group in February 2008 andrecommendations were made for all therelevant areas, including the need to set up agroup to look further at this matter. This didnot happen until August 2008.

We noted that there had been a number ofserious untoward incidents involving a patientbeing given the wrong medication or one towhich they were allergic. In October 2005,there was an instance of a patient allergic topenicillin being given the drug in error, and asubsequent repeat error in January 2007,fortunately without reaction. However, thispatient was also not given other importantdrugs they had been prescribed for years. Thereport identified poor liaison and handoverbetween A&E and the ward, a matter reportedto us as commonplace by many staff over ayear later. The report also noted poorrecording of clinical notes, especially in A&E.

In April 2007, there was an instance of a patientnot being given insulin. The internalinvestigation found a number of failures butthese cannot be listed in this report, as thiscase was the subject of a police investigation.We noted in the minutes of the mortality groupin May 2008 that there was another instance ofa patient not given medication for theirdiabetes.

There was a serious untoward incident in theemergency assessment unit in September 2006,which involved the accidental infusion oflignocaine (a drug used to suppress fast

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rhythms of the heart and for pain relief) duringattempts to resuscitate a seriously ill patient.There were multiple missed opportunities tocheck the infusion, which should not have beenon the trolley. The patient subsequently died.This case has been the subject of an inquest atwhich a ‘narrative’ verdict was recorded.

In the report of his investigation, the solicitornoted that “if a similar incident occurredwhich could be linked to the management ofthe resuscitation trolley and action has notbeen taken by the trust, the consequencescould be serious”. We noted during ourunannounced visit in February 2008 that aresuscitation trolley on ward 10 had not beenchecked for some months, was missing someitems and contained some medication andinfusions that were out of date. The trustexplained that this was not the resuscitationtrolley used on the ward. However, this couldhave been confusing, particularly to an agencynurse. The trust took immediate action toremove the trolley. The other trolley, that wasmeant to be the one in use, had not beenchecked for 10 days. The investigation reportalso mentioned the lack of an ITU bed.

One of the recommendations from this incidentwas that “the trust needs to satisfy itself thatappropriate training is being given on basic lifesupport skills (BLS) and that appropriate staffare attending”. However, we found that thetraining on BLS was part of induction andmandatory training, both of which had variableattendance records. For example, in November2007 the board noted that the reduction inattendance at induction was “disappointing”and the hospital management board the samemonth noted that a third of staff had notattended.

In July 2008, there was another error involvingan infusion. Staff noticed that a patient beingresuscitated in A&E was being given aninfusion with an inappropriate component. Theprocedure was stopped and the patientsuffered no ill effects. It was noted that thetrust’s policy had not been followed.

In May 2007, during the refurbishment of A&E,an ambulance crew arrived at 1.30am butfound that the normal doors they used were

locked. They had to use an alternative route,which led to a delay. The report into thisincident found that staff were confused as tothe proper procedures for the closure of thedoors. The report also noted problems inrespect of the support for staff, their moraleand information. It recommended that seniormanagement needed to address themanagement structure and resources withinA&E as a matter of urgency.

It was not clear to us at what point seriousuntoward incidents were reported to the trust'sboard. The trust explained that board memberswere notified by email when a seriousuntoward incident was reported electronically.The serious incident involving the infusion oflignocaine happened in September 2006 butwas not reported to the board until its privatemeeting in January 2007. Serious untowardincidents were reported to the executivegovernance group, which reported quarterly tothe board, but few details were provided. Therewas little evidence in the minutes of discussionof the issues raised by serious incidents. Therewas no record of the board discussing at thetime the serious incident in April 2007 thatbecame the subject of a police investigation.

Inquests

The trust acknowledged that they needed aprocess to learn from inquests and also all thecases that come through litigation. We notedthat there was no link between inquests andthe other components of governance. Manycases that went to inquest should have beenreported as adverse events and properlyinvestigated.

A discussion was held in the summer of 2008with the legal team on how to improve theprocess. The legal team had not been sharingtheir investigation reports; they had paid forreports for litigation cases where there wereinvestigations but the reports had not beenconsidered as part of risk management.

The trust acknowledged that they shouldattend relevant inquests and, in advance ofthese, the trust should routinely undertake aninvestigation to identify any concerns.

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The trust’s system for identifying andresponding to information aboutoutcomes for patientsThe trust had a history of poor performanceon mortality. The data from Dr Foster show athree-year hospital standardised mortalityratio from 2003-2006 of 125. This was thefourth highest ratio in England. There was noevidence that the trust had taken any action inrespect of this at that time.

The first reference to the Dr Foster hospitalstandardised mortality ratio (HSMR) was in theminutes of the executive governance group inFebruary 2007, when they referred to theprovisional score in 2006 of 114. In May 2007,the medical director presented the figures tothe hospital management board. The HSMRhad been adjusted to 127 and the trust was thefifth worst in the country for its standardisedmortality when using the 55 diagnoses andprocedures that comprised the HSMR. The

medical director announced that a group hadbeen set up specifically to look at mortality.

In the next meeting of the executivegovernance group, it was reported that theclinician with responsibility for clinicalgovernance was looking into apparently highrates of mortality at the weekends for medicaladmissions. Later, it was noted that, since theappointment of the acute care physicians, thisweekend peak had vanished.

By July 2007, the executive governance grouphad been reassured that the high HSMR wasbecause of poor coding. It was noted that anin-house team had looked at all the case notesof deceased patients over the last quarter andfound that 75 diagnoses had changed.

In the meeting of the executive governancegroup in April 2008, the feedback from themortality group was that 70 deaths had beenreviewed and that most were predictable withno “care issues” identified. The clinical qualityand effectiveness group noted in February2008 that four or five cases needed furtherinvestigation because of poor notes or noreview by a senior clinician. The clinicians whoreviewed the notes had volunteered to beinvolved. As noted earlier in this report, theydid not use a structured proforma or have asystematic approach to the review. We havealready identified concerns that these reviewsfailed to identify poor care and learn lessons.Even when concerns were identified, actionwas not taken in a timely manner.

For example, we saw earlier in the report thatthe review of the care of four patients who haddied (following operations coded as “jejunal’)identified some concerns. These involved thefailure to give medication to a patient who was‘nil by mouth’. This matter had not beenresolved satisfactorily one year later.

• The trust was in the top (that is, worst)20% for staff witnessing mistakes andnear misses.

• Staff, including senior staff, had littleconfidence that the trust learned fromincidents.

• Responsibility for responding to the issuesraised by incidents had been devolved tothe divisions, but there was little evidencethat this had resulted in change.

• Some serious incidents were not reportedas serious untoward incidents. Theseincluded many cases that went to inquest.

• There had been repetition of some typesof serious incidents.

• There was delay in reporting the seriousincident involving lignocaine to the trust'sboard; there was little evidence ofdiscussion of serious incidents by the board.

Findings of fact on incident reportingand serious untoward incidents

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Clinical audit

Sources of evidence

• Minutes of the meetings of the trust’s boardand of the clinical audit committee

• Interviews with staff past and present

• Summary audit reports

Clinical audit is a process that aims to improvethe care of patients and outcomes for patientsby carrying out a systematic review andimplementing change. Aspects of care areselected and evaluated against explicit criteriaand, where necessary, changes are made atan individual, team or service level. Furthermonitoring can then be used to assess theimprovements.

Although there was a central team to facilitateclinical audit, which was meant to maintain acomprehensive database of audit projects,they were not always aware of all audit activityin the trust. The audit facilitators attendedgovernance meetings in the divisions.However, the clinical audit lead said there hadbeen some disconnection between thedivisions, and departments within them, andthe central audit team.

Before April 2007, when the current clinicallead for audit started, there had been a gap ofa year when there had not been a lead. Thetrust-wide group for clinical audit also did notmeet for a year between May 2006 and April2007. The current lead for clinical audit tookthe role on in addition to other research anddevelopment commitments and acknowledgedthat it represented a substantial workload.

Some staff, including senior clinicians andthose in senior governance and executiveroles, described audit as having been weak.Many staff described audit as being“disjointed”, both with regards to the centralaudit function and the absence of a linkbetween audit and the other components ofgovernance.

The chief executive told us that it was hisexpectation that audit should be stronger andhe was disappointed that it had not been so.

We were interested to know how datainfluenced clinical audit; for example, ifevidence of poor outcomes triggered audit inthe relevant area. Senior medical staff in theclinical divisions said that audit was not drivenby data.

Participation in national audits is an effectiveway of comparing the performance of the trustwith others. Members of the central auditteam were aware of national audits and saidthey tried to ensure that the trust participated.Some clinicians that we spoke to said thatthey were aware of participation in, forexample, chronic obstructive pulmonarydisease, stroke, the Myocardial InfarctionAudit Project (MINAP), and patients withgastrointestinal bleeds. However, they werenot able to produce any results other than forstroke. The trust did not participate inspecialist colorectal or vascular or otheraudits run by some of the specialist societies.

A number of senior clinical staff described theaudit planning process as poor or patchy.Some were unsure how it was meant to workand one non-executive director described theplan presented to the board two years ago as“a mess”. The board asked the internalauditors to review clinical audit. Their reportconsidered that clinical audit did not providethe board with assurance that clinical auditfunctioned as well as it should.

We were also told by many staff that whenaudits were undertaken, changes did notusually occur and there was a lack of follow-up and closing the loop. However, an audit inpharmacy had resulted in an increasednumber of pharmacy staff on the emergencyassessment unit.

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The trust's overall system for clinicalgovernance

Sources of evidence

• Interviews with staff past and present

• Trust documents, including minutes ofmeetings and reports on clinicalgovernance

There had been several changes to thearrangements and accountability forgovernance at the trust since 2005. When thechief executive arrived in an interim capacityin August 2005, the arrangements for

governance included a risk managementcommittee and a clinical governancecommittee. However, there was a consensusamong the staff we interviewed that thearrangements were not effective at that time.

We noted that, in March 2006, the trust'sboard decided that the clinical governancecommittee would no longer report to thepublic meeting of the board, but only to theprivate part of the meeting. The chiefexecutive and chairman could not recollect thebasis for that decision.

An integrated risk and governance committeewas established in December 2005 as a sub-committee of the board, in order to improvethe arrangements for governance. Followingthe results of a review by internal audit, thiswas replaced by the executive governancegroup, which had two non-executive directorsas members. This group reported to the auditcommittee, which reported to the trust board.

For much of the time under consideration,there had been little in the way of a team tosupport the head of governance and theclinical lead for governance. More recently, agovernance team had been created.

During 2007, the trust took steps to revise thereporting mechanisms for governance. Theclinical governance committee was replacedby the clinical quality and effectivenesscommittee in June 2007. Clinical groups fedinto the clinical quality and effectivenesscommittee. This reported to the executivegovernance group.

From April 2007 to October 2008, the executivegovernance group reported on a quarterlybasis to the audit committee. All non-executive directors, apart from the chair,attended this committee.

Much of the executive responsibility for clinicalgovernance rested with the director ofnursing, but the responsibility for clinicaleffectiveness and clinical audit was with themedical director.

The governance structures had been subjectto external scrutiny as part of the process ofacquiring foundation trust status. In addition,

• The trust had a history of poorperformance in respect of reportedmortality.

• The trust did not take action on mortalityrates until the HSMR of 127 was publishedin April 2007.

• The trust considered that the cause of thehigh rate was poor coding and took actionto address this.

• The trust established a mortality group.

• The reviews of deaths were not structuredor robust.

• The trust-wide group for clinical audit didnot meet for a year.

• There was no lead for clinical audit for ayear.

• Clinical audit had not been well planned.

• Clinical audit was not linked to the othercomponents of governance.

• Data on outcomes was not used togenerate audit.

• The trust did not participate in the auditsof the specialist medical and surgicalsocieties.

Findings of fact on the approach tooutcomes, and on clinical audit

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the NHS Litigation Authority had assessed thestandards for risk management, and theHealthcare Commission had assessedstandards as part of the annual heath check.For both of these, the trust provided evidencethat the structures were adequate and thiswas accepted.

However, although we could see that reportson key elements of governance such asclinical incidents and complaints, went to theclinical quality and effectiveness committeeand the executive governance group, therewas little evidence from the minutes of theboard that these were ever discussed or thataction was taken in response. The secretary tothe board and members stated that theminutes did not reflect the balance of whatwas discussed, since decisions and actionwere noted rather than any debate. We noted,however, that this did not appear to apply tofinance or marketing, and that few actionswere noted in respect of quality.

As demonstrated in this report, the structuresdid not serve to raise awareness of seriousproblems with clinical care in emergencyservices in the trust, or the potentialimplications of the major reduction in staffingin 2006/07.

Turnover at the board

There had been considerable change in themembership of the board since April 2005. Thechief executive, who had been in post for manyyears, went on secondment in the spring of2005 and then left. The current chief executivejoined on an interim basis in August 2005 andtook the post on a permanent basis inFebruary 2006. The previous medical directorretired in March 2006 and a replacement wasnot appointed until September. In the interim,the deputy medical director supported theboard. The previous director of nursing left inJuly 2006 and her replacement took up post inDecember that year. A senior nurse acted inthe post for six months. That meant that, formuch of 2006, the trust's board did not have apermanent clinical director in post. It wasduring this time that the major reduction in

workforce was agreed and implemented. Theproposals were considered and supported atthe hospital management board, which theclinical heads of division and other clinicalpost holders attended.

Clinical engagement

Engagement and openness with clinical staff,and getting their input and buy-in, is animportant means of improving quality in theNHS. We gathered an overall impression frominterviews and minutes of divisional meetingsthat the trust was at an early stage in respectof clinical engagement. There had been littleunderstanding or ownership by senior doctorsof the role, for example, of heads of divisions(clinical directors) or clinical leads.

Members of the board generally felt thatengagement with clinicians had improved butthat there was still progress to be made.

The chief executive told us that there had beena huge amount of work in relation to clinicalengagement. This included appointing clinicalleads across the trust for audit, training,governance and so on, and the development ofdivisional governance structures in which thetrust wanted full participation. The post ofmedical director was considered to besignificant in promoting engagement but thispost was effectively vacant for much of 2006,in between the retirement of the previousmedical director and his replacement takingup the post.

Evidence from minutes and interviewssuggested that many of the clinicians were notfully engaged with governance, or evenresisted it. For example, a senior consultanttold us that meetings to consider mortalitywere for the profession only and were nothingto do with governance. In the surgical division,attendance by consultants at the divisionalgovernance meetings was poor. For example,there were at least four meetings in 2008where only two consultants attended and twomeetings in 2007 where only one consultantwas present.

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Many consultants recognised that the trusthad a clear direction and had made progressin controlling finances. However, a recurrentcriticism of clinical engagement was aperception of a top-down approach bymanagement at the trust. The managerialapproach was described as an attempt to“dictate and impose”, creating what oneconsultant described as an “us and them”culture. Several were critical of the decisionsmade by management, especially when theywere not consulted on the decision prior to itsimplementation. It was reported that thiscontributed to a sense of professionaldisempowerment. One consultantsummarised that consultants were becomingworkers rather than professionals, asgovernance at the trust was something thatstaff felt happened to them rather thanengaged with them.

Some clinicians considered that the trust didnot respond to the problems they raised.These included the ongoing problems in A&E,the low nurse staffing levels and the failure tohave adequate operating time at weekends.Many reported that there was a gap incommunication, whereby managers did notconsider the impact of changes on the care ofpatients and clinicians’ views were not takeninto account. Many doctors told us theybelieved that some decisions had been purelydriven by finance, without regard for patientcare. Some reported that they had identifiedthe risks of the programme for thereconfiguration of the clinical floors and thelow nurse staffing levels, but had beenignored. Others felt “steam rollered” intoaccepting the proposal. Many consultants thatwe spoke to felt that senior managers did notwelcome critical comments, the managementstyle was inflexible and they felt marginalised.

Culture of the organisationThe clinical governance review in 2002 advisedthat the trust needed to develop an open andlearning culture.

In the national NHS staff survey for 2006, thetrust did well with a low percentage of staffexperiencing harassment, bullying or abusefrom either patients or other members ofstaff. It did poorly on appraisal, training andthe extent of positive feeling within theorganisation.

In the 2007 survey, again a relatively lowpercentage of staff said they had experiencedharassment, bullying or abuse from patients,but in this survey the trust was in the worst20% for bullying or abuse from staff.

• Many staff said that governance was weakin the trust until 2005.

• The committees and reportingarrangements had been revised; thestructure for governance did not report tothe public meetings of the board.

• For six months in 2006, the trust did nothave a substantive medical director ordirector of nursing.

• Many senior managers and boardmembers considered that progress hadbeen made in ensuring that clinicianswere properly engaged in governanceprocesses.

• Attendance by doctors was poor atsurgical governance meetings, and manydoctors felt marginalised in general anddisengaged from the system ofgovernance.

• Many consultants considered that theywere not listened to, and that the trust didnot welcome constructive criticism orheed concerns that proposals could have anegative effect on the care of patients.

Findings of fact on the overall systemfor governance and clinicalengagement

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It continued to perform poorly on appraisal,training and the extent of positive feeling. Inthis survey, the results showed the trust to bein the worst 20% with regard to the pressureof work felt by staff and on work-life balance.Overall, the trust featured as one of the worst20% of trusts in 14 sections of the survey, asone of the best 20% of trusts for one section,with the remainder falling into theintermediate group of trusts.

We did not gain an impression from staff thatthe trust had had an open culture in whichconcerns could be raised, were welcomed andresolved. We have noted above that severalconsultants considered that the trust did notwelcome criticism or concerns.

The trust’s board appeared averse to criticismof services. Poor results from inpatient or staffsurveys were not discussed in public. Thetrust had a good relationship with the chair ofthe patient and public involvement forum, whowas very supportive of the trust. It did notwelcome concerns being raised by individualmembers of the forum. The information on thedoubling of the rate of C. difficile infection inthe early months of 2006 was not released tothe board or the public. This was when theprevious director of nursing was the directorof infection prevention and control. At themeeting of the hospital management board inJune 2006, it was noted that the trust was thefourth worst in the SHA in terms of C. difficile.There was also a high proportion of deaths inpatients with C. difficile. This information wasnot shared with the board or the public either.We were told by relatives and members of thepublic that the trust at that time was reluctantto release information relating to C. difficile.

Many staff told us that the chief executive wasclear and decisive and that he had “turned thetrust round”. Many said he had a visiblepresence in the trust, although somedisagreed. Some, particularly consultants,said that he had a heavy hand and did notwant to hear about the potential problemsposed by the decisions made about services.

How the board functioned

We were told that, since the arrival of thechairman and the current chief executive, theboard had become much more effective,particularly in having a clear strategicdirection and receiving the information onperformance to help to deliver this. Theprevious board was said to have lacked focusand there had been concerns about internalcontrols. The new board had achieved financialstability and acquired NHS foundation truststatus. Links with external organisations weresaid to have improved. Many staff wanted togive credit to the leadership for this, even ifthey had concerns about aspects of care forsome patients.

We analysed the minutes of the trust's boardmeetings from April 2005 to 2008. Theminutes indicated that discussion at the boardwas dominated by finance, targets andachieving foundation trust status. Other areasthat commanded much of the board’s timeincluded the trust divesting itself of thelaundry service. The minutes of the variousgovernance committees were noted, but therewas no record of any discussion and issuesthey raised were not highlighted.

Although we have seen that there wasevidence 'in the system' about poor standardsof nursing care, there was little evidence thatthis had been discussed by the board or thateffective action had been taken. It was seldompossible to identify discussion at the board ofcorporate matters raised by reports of clinicalincidents, claims or complaints. As we havenoted before, the secretary to the board statedthat the minutes did not accurately reflectdiscussion at the board. There was no recordin the minutes of decisions or action taken onthese matters.

When the responsibility for most of the systemfor risk management and governance wasdevolved to divisions in early 2007, initiallythere was no accompanying robust system topolice or monitor this. The trust has said thatinternal audit reviewed these processes aftersix months as planned.

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Although the trust’s board sought to reducethe proportion of clinical jobs to be lost, thedecision by the board in 2006 to reducesignificantly the number of staff had an effecton the number of clinical staff, particularlynurses. The trust could not provide evidence ofa formal assessment by the board of thepotential risks that this reduction might haveon the quality of care. The programme toreconfigure the clinical floors meant thatsenior sister posts were also lost. The effectsof this have been considered earlier in thisreport.

We noted that the trust's board generallydiscussed matters in private. Discussions inprivate should normally be restricted tomatters that are commercially confidential orrelate to individuals. In June 2005, the minutesof the private part of the meeting recordedthat the Scottish country dancing club metweekly in the gym.

In March 2006, the trust’s board decided thatonly the audit committee would continue toreport to the public part of the board meeting.Other committees, including governance andrisk, and finance, would report only to theconfidential part. This was an unusualarrangement, which reinforced a preference toconduct the board’s business in private. Neitherthe chief executive nor the chairman was ableto explain why this decision was taken.

We noted that many items of business of thetrust’s board that would normally bediscussed in a public meeting were onlydiscussed in private session. These were notmatters of commercial confidentiality. Forexample, we have mentioned that there was aserious outbreak of C. difficile in the earlymonths of 2006 and the numbers stayed highfor the rest of the year. The outbreak was notreported to the board or the SHA.

Matters that could have been of interest to thepublic were noted only in private, such as thedecision in August 2006 to take on the servicesof a public relations company, following thedeparture two months earlier of thecommunications manager. This was at thetime that the trust was losing at least 150

posts. Another example that was notdiscussed at a public meeting of the boardwas the reported high hospital standardisedmortality ratio. In July 2007, after Dr Fosteragreed that the rate could be considered to bebelow average if a wider comparison wasmade, the board decided that a press releasewould be counterproductive. We assume thiswas to avoid drawing attention to the originalpublished rate, which was high.

Other examples of matters discussed only inprivate included the alerts on high mortalityreceived by the trust from Dr Foster, theresults of the national staff survey, thehygiene code visit in 2007, the annual reporton infection control, the report of the localsupervising authority for midwives in the WestMidlands in January 2007 and the review ofA&E in May 2007.

The trust did not discuss in public the sharedvascular on-call rota with the UniversityHospital of North Staffordshire in Stokewhereby, for five weekends out of seven,patients coming as emergencies with vascularproblems would be treated at UniversityHospital. This rota was agreed in September2007. In the private meeting of the board thatmonth, it was reported that the surgeon wouldgo to the patient rather than the other wayround. This was not actually correct, since theambulance service had instructions to takepatients to the trust that was on call. The trusthas explained this was an uncorrected error inthe minutes.

In November 2006, the trust agreed to meet inpublic every three months instead of monthly.

In February 2007, at the private meeting of theboard, it was agreed that the minutes shouldavoid using the names of contributors. Wenoted that when the trust gained foundationtrust status, the directors decided to hold alltheir board meetings in private. This is not arequirement for foundation trusts, some ofwhom hold their meetings in public. Themeetings of the governors were held in public,as is required.

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The history of key issues, including thefinancial position of the trust and theprocess of becoming a foundation trust The final deficit on income and expenditure forthe year 2004/05 was £2.15 million. Thisincluded a £500,000 deficit from the previousyear.

In August 2005, the interim chief executiveattended his first meeting of the confidentialpart of the trust’s board. He said that marginalclosures were not enough and radical moveswere needed to get the trust back on trackfinancially. The previous director of nursingpresented a paper from the executive directorson the reconfiguration of wards. This was toreduce beds, staffing costs and lengths of stay.

In October 2005, the trust predicted a deficit atthe end of the year of £2 million. In the event,it achieved a surplus of £500,000, because ofactions taken and an agreement with the PCT.

At the meeting of the trust’s board in October,the minutes recorded the huge amount ofwork entailed in the programme to become afoundation trust and the need to ensure thatthe core business was not affected. We notedthat the board had had at least two ‘away days’to consider foundation trust status, one in May2006 and another in June 2007.

The trust, under the previous chief executive,had an earlier attempt at becoming afoundation trust, but this was unsuccessful. InDecember 2005, the trust established acommittee to achieve foundation trust status.It was noted at the board meeting thefollowing month that the project for thesurgical floors would save nearly £600,000.

In March 2006, the board received an assurancefrom the previous director of nursing that therewere robust plans to ensure that patients werenot disadvantaged during the next phase of thereconfiguration of services. She confirmed thatappropriate facilities would be in place toprovide patients with privacy and dignity. InApril, the previous director of nursing told theboard that the clinical floors project had beenfocused on delivering care in a different way,and improving the environment for privacy anddignity.

In March 2006, the minutes of the trust’shospital management board stated that theworst-case scenario was a £370 million deficitfor the SHA. The minutes recorded that a 2%top slice reduction of the allocation for PCTsand a further 1% reduction on a differentialbasis had been discussed at the chiefexecutives meeting in February. The chiefexecutive of the trust stated this was a seriousposition and plans needed to be in place toaddress this. At the board meeting that monthit was noted that the trust had started the yearwith an underlying deficit of £2.15 million.From April, the trust would face a shortfall of£10 million. The trust initiated action toremove beds and reconfigure wards, and toremove 150 posts at the trust.

At the meeting in April 2006 of the trust’sboard, it was noted that the financial aspect offoundation trust status would be “easier to

• In 2007, the trust was in the worst 20% onthe extent of positive feeling among staff.

• Most staff did not feel that the trust hadan open, learning culture.

• Most senior staff considered that theboard now had a clear strategic direction.

• The minutes of the board show thatfinance and achieving foundation truststatus were given high priority. There waslittle recorded discussion about quality ofcare.

• The trust’s board preferred to conduct itsbusiness in private.

• Many important matters of public interestwere not discussed in public, including anoutbreak of C. difficile, the high hospitalstandardised mortality ratio, and theannual report on infection control for2006/07.

Findings of fact on the culture of theorganisation and how the boardfunctioned

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handle if the trust were on a firmer financialfooting”. In the confidential part of themeeting, the director of finance also referredto the difficulties facing the then strategichealth authority.

The year 2006/07 was generally a difficult onefor NHS trusts, as there was a nationalrequirement to bring the service into financialbalance.

The director of finance at the SHA (Shropshireand Staffordshire SHA) at that time, however,did not recollect that the trust had aparticularly difficult financial position or thatthe trust was asked to make draconian cuts.However, the trust provided evidence that hehad been given details of their plannedreduction in costs. The financial handover tothe new strategic health authority in July 2006noted that the trust had done well in 2005/06with a surplus of £500,000 and was onschedule to deliver a £1 million surplus in2006/07.

Although the divisions had undertaken riskassessments, we could not find any evidencethat there had been an assessment of therisks at corporate level of the workforcereductions in 2006/07.

In June 2006, the board noted that the surplusat the end of 2005/06 was an excellentoutcome, particularly leading up to applicationfor foundation trust status.

In July 2006, the board received an internalassessment of progress on the NationalService Framework for Older People. Thisstated that the trust was proactive with regardto privacy and dignity. In the private session ofthe board, it was noted that the trust hadperformed poorly in a review of children’sservices due to the failure to provideinformation. It was agreed to take action. Theboard discussed the need to build positiverelationships with the media and agreed totake on the services of a public relationscompany with immediate effect. This was toreplace the communications manager whohad left two months earlier. The hospitalmanagement board that month noted that 50redundancies had been agreed and a head of

marketing had been appointed, as part of therestructuring of management arrangements.

In August 2006, the trust’s board learned thatthe internal auditors considered that now thetrust had developed an assurance register, ithad moved from the lower to the upperquartile of trusts in respect of governance.

In private session, some non-executives said itwas hard to challenge at public meetings.Another said it would have been difficult tohave had, in public, the debate they had had atthe finance committee.

In September 2006, the trust’s board wasinformed by the director of finance that thetrust must adjust to new staffing levels. Themarketing plan was presented. The nextmonth was when A&E had no middle grade orconsultant cover for four nights a week, for afortnight. In November 2006, in private sessionthe board learned that the trust was on trackto deliver £10 million in savings in 2006/07and recurrently from 2007/08. In December,the private meeting of the board was informedthat action across the whole of the WestMidlands health economy was requiredfollowing identification of a £205 million cashpressure. The West Midlands SHA has told usit does not recognise this.

By January 2007, the minutes of the board andthe hospital management board record thatthe trust was on course to deliver a £1 millionsurplus at the end of the year. Although therewas evidence of clinical problems of which theboard was aware in a number of areas,including A&E and the medical wards, nosuggestion appears to have been made toreinvest in staff at this time. The trust has nowtold us that this £1 million was not a truesurplus, but to repay brokerage to the PCT.

In May 2007, at the meeting of the trust’sboard it was noted they had achieved asurplus of £1.12 million for 2006/07. It wasalso recorded in the minutes of the privatemeeting that day that the trust had had itsscore reduced on the risk rating for financesfor becoming a foundation trust. It wasconfirmed that Monitor looked for a score ofthree or above. The minutes note that “the

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only way that the trust could increase thescore to four would be by a major increase insurplus”.

At the same meeting, the trust learned fromthe national survey of NHS staff that a highproportion of staff did not have confidence incare and treatment at the trust. This wasdescribed as disappointing. The marketingteam presented its first report to this meetingand the minutes for this covered a page, as didthe section on the laundry. The results of the2006 national survey of inpatients took up oneparagraph in the minutes. They recorded thataction plans were in place to address areaswhere the trust was in the worst 20%.However, there was no mention of thepatients' concerns about there being too fewnurses and there was no action plan toincrease the number of nurses. The minutesrecord the need for more discussion in public,but state that a high percentage of the itemsto be discussed were commercially sensitive.

The board secretary said that her approachwas to make the minutes as short as possibleand record decisions taken by the board andnot the detail of debate. She reported thatMonitor would be looking for evidence of theboard's decision-making process andchallenge, in respect of the laundry andfinance, and therefore produced fuller minuteson those issues than she would otherwisehave done. She reported that the balance inthe minutes was not a reflection of the debatethat took place.

In June 2007, the board discussed at somelength in private session the Dr FosterHospital Guide, which ranked the trust as fifthhighest in the country for its mortality rates.This was explained as being partly due to“data capture”. The board learned that amortality group was being set up.

In July 2007, the board in private sessionagreed a draft strategy to engage with patientsand the public. A detailed report on marketingwas presented and it was agreed that the trustneeded to be increasingly aware ofcompetition. This was the month when the‘annual’ report on infection control was

received, but the minutes do not record thatthe outbreak of C. difficile in 2006 had beendiscussed. A programme to improve theprevention of infection was agreed.

The board also noted progress towards a costimprovement programme to achieve savings of£8 million recurrently over the next two years.If this were achieved, it would meet thenational requirement to improve costs andincrease the surplus. The board had learned inthe same month that there were 103vacancies. The board noted a vicious circle insome areas: the actual number of staff wasbelow the establishment, leading to highlevels of sickness, which in turn put pressureon budgets due to overtime. The need to breakthe circle was noted and blockages torecruitment were identified.

In August 2007, the minutes of the board inprivate session covered one and two sidesrespectively on marketing and the laundry.The only clinical matters minuted wereinfection control and theatres, which occupiedone side.

In September 2007, it was recorded at theprivate meeting of the board that there were104 vacancies but that significant numbers ofnew staff were due to start. The trust wouldhave a target of £3.48 million for the costimprovement programme for 2008/09. Thethree alerts from Dr Foster were also noted.The last public meeting of the board inNovember 2007 noted good progress onfinance.

On 1 February 2008, the trust achievedfoundation trust status. In the March meetingof the board of directors, it was recorded thatat the end of February the trust had a surplusof £1.87 million. It was agreed to invest innursing. In April, the surplus at the end of the2007/08 year was reported to be £853,354.

In May 2008, it was confirmed to the hospitalmanagement board that the trust hadachieved a surplus of £1.2 million in 2007/08.

At the meeting of the hospital managementboard in August 2008, it was noted that thetrust would aim to save £3 million in 2008/09.

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We noted that much of the board's time wastaken with the process of the application tobecome a foundation trust, includingconsidering issues such as businessdevelopment and marketing.

Members of the trust’s board were adamantthat the quality of care had always been a toppriority for the trust. They were not however,able to point to evidence of any significantscrutiny of standards of care of patients thatthey had undertaken. Many members of staffat all levels and in different professions told usthat the trust's priorities had been finance andachieving foundation trust status.

• The year 2006/07 was generally difficultfor NHS trusts, as there was a nationalrequirement to bring the service intofinancial balance.

• The trust made savings in 2006/07 and in2007/08 to maintain financial stability,having ended the previous years with adeclared financial surplus.

• In early 2006, the trust’s board wasreassured by the previous director ofnursing that the reconfiguration ofservices would not disadvantage patients.

• There was no evidence of any assessmentat corporate level of the risks to patientsfrom the reduction in the workforce.

• The board was focused on becoming anNHS foundation trust, which it achieved on1 February 2008.

• Members of the board insisted that qualityof care was a top priority, but the minutesdid not support this.

• Many staff considered that the prioritieshad been finance and achieving foundationtrust status.

Findings of fact

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Following our final visit to the trust in October2008, we wrote to the trust to outline thoseareas that it needed to concentrate on beforereceiving the draft report. This letter isreproduced in appendix H. The trust repliedoutlining the progress it had made on thematters raised.

Progress in A&EDuring an investigation, it is our policy to raiseany issues of concern regarding the safety ofpatients immediately with the trust beinginvestigated. As we have noted, the trustreceived formal notification from theCommission on 23 May 2008 about the A&Edepartment. This covered three main areas ofconcern: staffing, the structure and operationof the department, and governance.

The trust responded that they took theconcerns "extremely seriously" and set up anemergency care steering group that has metmonthly since June 2008 to address theissues. This group engaged an external lead,previously a national lead for emergency careat the Department of Health. Theimprovement project for the department wasbased on a model of care and was split intoeight work streams.

The trust commissioned an expert team fromthe Heart of England NHS Foundation Trust toconduct a review of the department.

In a press release of 25 September 2008, theHealthcare Commission acknowledged thatthe trust had responded positively and rapidlyto the concerns raised.

The trust appointed two consultants inemergency medicine and one long-termlocum consultant. However, the originalconsultant is on long-term sick leave. One ofthe new consultants has been appointed as

the clinical lead for the department. Theexpansion of the middle grade medical rotahas resulted in an improvement in the trainingand education available to junior doctors. Thedepartment has structured programmes forjunior and middle grade medical training inconjunction with University Hospital of NorthStaffordshire NHS Trust. Unlike previously,these are protected sessions that are notcancelled on operational grounds. The deanfor postgraduate medicine is satisfied with thechanges that have been made. Junior doctorshave a mentor in the department, and giventhe greater presence of middle grade doctors,a more supportive environment. The trust nowoperates a rota with permanent staff that iscompliant with requirements. The acutephysicians no longer participate in the rota.

The trust increased the nursing establishmentto 53.2 whole-time equivalents and all postsexcept the lead nurse have been filled. Thetrust appointed a matron to cover A&E and theemergency assessment unit. A number ofrelatively senior nurses left the departmentbetween May and August 2008 and, therefore,the recruitment programme was partly aprocess of replacing experienced nurses wholeft the department with inexperienced ones. Anurse to take forward professionaldevelopment was also recruited and shedeveloped a training programme, which isbeing implemented. However, there is stillonly one band seven nurse acting in a clinicalcapacity.

From October, triage was being performed bynurses between 10am and 10pm. A trial wasstarted in August 2008 with generalpractitioners working in the departmentassisting with triage and the minor patientstream. They were undertaking triage between6pm and 10pm.

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Developments at the trust since the start of theinvestigation

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Both the Healthcare Commission'sinvestigating team and the reviewing teamfrom the Heart of England Foundation Trustwere concerned about the use of the four-bed‘assess and treat’ unit. The latterrecommended it was closed immediately.During an observation of the department inSeptember 2008, the directorate manager foremergency care explained that due to theproblems associated with it, the ‘assess andtreat’ area was closed. We understand it iscurrently used only for patients waiting to gohome or for an assessment by an occupationaltherapist.

During interviews with staff and observationsof the department in September and October2008, the investigating team was consistentlytold that equipment had been ordered. InAugust 2008, a department business meetingtold how equipment on order was due inapproximately four weeks. However, inSeptember, the team were told there was noconfirmation of arrival and in October 2008 theteam was again informed that the requestedequipment was still on order. Most of theequipment has now arrived.

Access to radiology, particularly CT scans,remained a concern in October 2008, with onelocum consultant stating they were verysurprised to have joined the trust and foundthere was almost no relationship between theemergency department and radiology. Thetrust has told us that this has improved.

A new model of care, also incorporating theemergency assessment unit and clinicaldecision unit, was introduced in thedepartment on 1 September 2008 with fullimplementation of the model planned forOctober 2008. The trust reported earlyindications that the model was workingeffectively and progress would be monitoredby the emergency services steering group.Additionally, the medical director reported thatthe pathway from A&E to theatre was beinglooked at.

Governance arrangements had improved withthe new leadership, with regular monthlymeetings including reviews of mortality andclinical audit.

Emergency assessment unit, wardsand theatresFollowing an unannounced visit that we madeto the emergency assessment unit (EAU) inFebruary 2008, concerns were raised about anarea of eight beds at the far end of the unitthat were out of sight from the nurses' station.In May 2008, 12 beds were removed from the48 beds and were used to open a clinicaldecision unit in the A&E department. As aresult, the bed capacity of the unit wasreduced and with staffing levels unchangedthere was an increased ratio of nurses perpatients.

In October 2008, four beds were temporarilyreopened in this area of the unit, a decisionmade by the executive on-call. Due to"significant pressure" on the trust, it wasintended that five additional beds would bebased on the EAU, with bank and agency staffbeing used to cover while the recruitment ofadditional staff is undertaken. Since then,continuing pressure on beds has led to extrabeds frequently being used.

A refurbishment of the unit had beenscheduled for March 2009. The trust has nowappointed healthcare planners to reviewcapacity and configuration of clinical areasand a report is anticipated in March 2009.

In July 2008, there was one trained member ofstaff to every 10 beds on the EAU. InSeptember 2008, it was reported that, as therewere 5.2 whole-time equivalent staff onmaternity leave (described as some of themore experienced and competent staff), itcould be May 2009 before they would beoperating on full numbers. The trust assuredus that the unit received additional resourcesand that bank and agency staff were booked tocover vacancies.

In August 2008, it was noted that the numberof junior doctors for the EAU had increasedand funding was available for a third seniornurse advanced practitioner. In September2008, we learned that the rota with three acutephysicians might not be sustainable,especially if they tried to match the RoyalCollege of Physicians recommendations of

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seeing patients within a given time. In October2008, the trust stated they believed thenumber of doctors in support of medicalpatients on the EAU was appropriate. Thetrust outlined intentions to increase thededicated senior presence to four acutephysicians and bid for an acute medicinespecialist registrar early in 2009.

A band seven nurse for professionaldevelopment in emergency care wasappointed, with the post holder taking upposition in October. An analysis of trainingneeds was undertaken to identify trainingrequirements and prioritisation.

Following concerns of the HealthcareCommission regarding the recording ofmodified early warning scores (MEWS), a rapidtraining assessment was undertaken by thetrust practice development team. DuringAugust 2008, 21 members of staff from theEAU were trained, and the trainingprogramme is ongoing.

A training assessment undertaken by thetrust's practice development team agreedactions specific to the cardiac monitors in theEAU. These included education aimed at allnurses and healthcare support workers; designand implementation of guidelines for the use ofcardiac monitors; and competency-basedtraining for use of the monitors and recognitionof life threatening arrhythmias. The trust wouldevaluate and monitor the effectiveness of theguidelines and training. The trust says it hasnow trained all the staff on the EAU, and someon A&E with more to follow.

In September 2008, the following actions hadbeen identified and were implemented: ward-based training was provided to all medicalclinical areas (including the EAU);expectations regarding the use of MEWS werecommunicated to all clinical areas; MEWStraining was provided on new starter days fornurses and healthcare support workers;matrons were to ensure full completion ofMEWS on their quality ward round; and auditof the effectiveness of current MEWS chartswith action on findings as required.

Following a medical division assessment thatfound there was poor compliance andaccuracy with fluid balance charts, it wasagreed that a single chart should be usedacross the trust with explicit expectationsregarding the standard of documentation, andward-based training provided.

In October 2008, one of the acute physicianswas completing an audit around directadmissions and length of stay. Although somepatients stayed on the assessment unit formore than a week, overall compliance with themaximum length of stay outlined in theoperational policy was good, with an estimated5% remaining on the unit over 72 hours.Patients staying in excess of this were primarilythose requiring side rooms. The average lengthof stay in October 2008 was 1.6 days.

In October 2008, the trust acknowledged that,although there were some pathways in placefor emergency admissions, this was an areathat would benefit from further development.The operational policy, last revised inDecember 2005, was being updated in October2008. This would review the policies in placefor the emergency department and set outpathways for all types of patients on the EAU.The policy required reworking to reflect thefact that bed numbers had been reduced sincethe policy was last revised, a new method ofworking had been introduced and there was anew set-up of senior medical staff.

The clinical lead for emergency caresuggested the key next steps for the EAUwould involve changing the emergency patientflow through the hospital. As part of this, GPreferrals would not go through the A&Edepartment. To begin with, these would gothrough the clinical decision unit until theassessment unit was functioning effectively.

In November 2008, new cardiac monitors wereinstalled on the acute coronary unit. The trusthas told us that portable suction equipment isnow available and is being rolled out acrossthe trust.

The trust had made representation to itscommissioner for extra resources to improvestroke services. The PCT, however, considered

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that the trust should do this within existingresources and the trust has agreed plans to dothis. On a specific issue, the trust hasintroduced a new type of thickened drink forpatients with difficulties in swallowing after astroke.

The trust is clarifying the position in respect ofaccess to critical care beds at the trust andelsewhere, and access to advice from criticalcare doctors, in the event of a bed not beingavailable.

Surgery‘Hospital at night’, a national initiative toensure that the best possible care is providedfor patients given the changes in permittedworking hours for doctors in training, hasbeen in effect since August 2008. As part ofthis, an analysis of activity was undertaken todefine the roles and responsibilities of thehospital at night team. In October 2008, thehead of division of surgery and the clinicaltutor wrote to all junior staff to encouragethem, pending a more robust solution, to seeka senior opinion whenever they considered itnecessary.

In July, we were informed of several changesand proposals to take place in the surgicaldivision. An action plan on surgical governancearrangements was included. This coveredareas such as the risk register, adverseincident reporting, complaint management,alerts issued via the Safety Alert BroadcastSystem, the NHS Litigation Authoritystandards, workforce information, staffappraisals, clinical audit, sickness absencemanagement and Dr Foster intelligence.

We were also told of changes that were beingmade to the management structure fortheatres, anaesthetics, the hospitalsterilisation and decontamination unit andcritical care, including appointing a clinicallead and a matron to work jointly acrosstheatres and the critical care unit. An actionplan has been developed for theatres. Theinitial problems with the electronic system forcollecting data from theatres have beenresolved.

The trust reviewed the surgical emergencypathway and the levels of input from surgicaldoctors. A four-bedded surgical assessmentunit was opened in November 2008 to enablesurgical patients referred by GPs and patientsadmitted from A&E to be assessed. Initially forpatients with general surgical problems andopen until 8pm, the trust reports that thereare plans to extend the service. Although theunit has helped to support the residentsurgical officer on duty, their workload is stillconsiderable.

Two additional beds have been opened on thetrauma ward to reduce the need for traumapatients to be on other wards. The trust isreviewing the provision of emergencyoperating lists at weekends to reduce delaysto patients. In the interim, additional sessionshave been arranged at short notice if there isa build-up of emergency patients requiringoperations. By the end of January 2009, therehad been four such sessions. Discussions areunderway about increasing the provision of theortho-geriatric service.

The trust has told us that a group is beingestablished to help prevent venous thrombo-embolism.

Staffing In September 2008, the trust told us that,since January 2008, 153 nurses started at thetrust (82 qualified nurses and 71 healthcaresupport workers). These additional staffresulted in growth (net of turnover) during thesame period of 46 qualified nurses and 51healthcare support workers. One additionalband seven had been recruited to cover wards11 and 12. The number of matrons hasincreased from three to 12. Some staff saidthat, while they welcomed the additionalnumber of nurses, many of the new staff wereinexperienced or newly qualified, requiringextra support.

At the November 2008 meeting of the trust’sboard, it was noted that recruitment had beenstopped at 40 posts below the agreed levelbecause of the difficult financial position for2008/09. The trust, though, has told us that

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the board has not stopped recruitment andwill, as part of the 2009/10 business plan,revisit the establishment review and take aview of recruiting to the outstanding posts.

Quality of nursing careIn June 2008, the trust’s board approved anaction plan to incorporate all the key issuesrelated to quality of care. This programme wasdeveloped with the support of an externalnationally regarded professional advisor, SirSteven Moss. The areas included in the planare quality of care, communication withpatients and carers, learning anddevelopment, staffing and clinical practice. Asteering group chaired by the director ofnursing was established in July 2008 and isresponsible for the ongoing monitoring andimplementation of the actions identified. Thetrust told us that, since April 2008, thenumber of complaints about nursing hasfallen, but information about seriousness wasnot available. However, the trust board inNovember 2008 noted an increase incomplaints about wards 10, 11 and the EAU.

A new chart for recording observations hasbeen on trial. Similarly, the trust says it hasintroduced one chart across the trust forrecording fluid balance. The trust has told usthat the matter of identifying patients whosecondition is deteriorating is one they haveelected to work on as part of the leadingimprovements in patient safety (LIPS) course.

In August 2008, a group was established tolook at the issue of patients who may wanderor abscond.

Details of developments in nursing at the trustfrom early 2007 to early 2009 were supplied bythe trust and can be seen in appendix I. Inaddition to these, the trust has also said thatthere have been the following developments:

• A balanced score card reflecting thatquality has been developed (and willdevelop further in time) and is presented tothe board on a quarterly basis.

• Development of a robust clinical skillsprogramme.

• Increased uptake of training programmes.

• Establishment of divisional patient andcarer councils, which are now meeting.

Governance and monitoringperformance, including mortality The trust has appointed a new medical director,who will take up the post in April 2009.

The mortality group has extended its remit tolook at a wider range of outcomes. It wasrenamed the clinical outcomes group inOctober 2008 and is chaired by the chiefexecutive. The trust is using a techniqueinvolving the global trigger tool to identifyissues of harm to patients. A team from thetrust completed the LIPS course provided bythe Institute of Innovation and Improvement.The trust reports it has developed a consistentapproach to the review of case notes and hasbegun to consider how it can learn fromdeaths that are the subject of inquests.

As mentioned earlier in this report, fourfurther mortality alerts (two generated by theDr Foster Research Unit and two generated bythe Healthcare Commission – see appendix E)occurred after the investigation was launched.We wrote to the trust about three of these inJanuary 2009. The trust responded to us aboutthe three alerts in a timely fashion and theirresponses have been considered by themultidisciplinary panel that oversees theCommission’s outlier work.

For the second quarter of 2008/09 (July toSeptember 2008), the Dr Foster HSMR forpatients admitted as emergencies was 79.7,which was significantly better than expectedwhen measured against the 2007/08 nationalbenchmark. However, there can be seasonaleffects reducing the HSMR for the summermonths. The crude mortality rate, among theHSMR group of patients, for this quarter was7.8%, which is below the rates reported for thecorresponding quarter in the two previousyears (which were over 9.2% and 9.7%) andsimilar to the 2005/06 quarter 2 rate of 7.6%.

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The most recent Dr Foster HSMR informationcurrently available is for October 2008, forwhich the HSMR is 82.9 and the crudemortality rate is 8.2% for emergencyadmissions. These are lower values than forthe previous three years.

Since December 2008, the executivegovernance group has reported directly to theboard. There is more evidence of discussion ofmatters of quality of care. Clinical audit is nowmanaged under the umbrella of governance.The frequency of the meetings of the trust-wide group for clinical audit increased tomonthly from December 2008. There is moresupport for the clinical divisions, with eachbeing allocated a manager for risk and patientsafety. The trust is reviewing the form forreporting incidents to make it easier to use.There are still concerns about the identificationand investigation of serious incidents.

There is evidence that the trust is aware ofproblems in the manner that it deals withcomplaints and has plans to rectify these. Thetrust has provided training to officers whoinvestigate complaints. However, the executivegovernance group noted in July 2008 that therewere still concerns with the provision of service,noting that: “Investigating Officers are failing tomake verbal contact with the complainantswithin 48 hours and agree a plan of action forthe management of the complaint.”

There is little evidence of an improvement inthe general analysis of complaints. None ofthe board minutes show any evidence ofevaluation of complaints to ascertainseriousness. The divisional governance groupsdo not minute discussions about issues raisedby complaints. The medical divisionalgovernance group noted in September 2008“significant failure in A&E particularly toadequately deal with these incidents and ageneral failure across the division to feed backto staff involved in dealing with the complaint”.A date of September 2009 was agreed for“robust arrangements [to] be in place acrossthe division to respond to and learn fromadverse events and complaints includingfeedback to relevant staff involved”.

A panel to review complaints was establishedin the medical division in June 2008 but it is atan early stage. In the surgical division, a panelhas not yet been established.

The trust implemented a new patientexperience tracker system in May 2008. Thisaimed to “gather patient and carers views atthe point of service and give a more accuratereflection of the services that are provided bythe trust” and “ensure that any shortfalls areaddressed immediately”. These reports areprovided to wards and included in thequarterly reports to the executive governancegroup. The trust board noted in November2008 that patients rated levels of cleanlinessas low.

The governors are taking an increasing roleand the trust has told us that they carry outunannounced visits. However, we understandthat these occur at regular times. In a recentevening visit we made to the trust, none of thestaff in A&E, the emergency assessment unitor wards 10, 11 and 12 was aware of anyinspection by governors.

Infection controlIn October 2008, the trust was subject to anunannounced inspection by the HealthcareCommission’s hygiene code team as part ofthe inspection programme of all NHS acutetrusts during 2008/09. The programme is tocheck whether trusts are meeting the 11mandatory duties outlined in theGovernment’s hygiene code, which came intoforce as part of the Health Act 2006.

The hygiene code team found that the trustwas demonstrating compliance with the code.No breach of the code was identified in any ofthe four duties considered.

Recent audits of prescribing of antibiotics havefound improved compliance with the policy. Anew prescription chart has been developed.The infection control team has been expandedwith another training post and a member ofstaff on secondment, who is targeting handwashing.

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South Staffordshire Primary Care Trust

Sources of evidence

• South Staffordshire PCT website

• Minutes of meetings and reports

• Letters and reports from localitycommissioning consortia

• Interviews with the senior managers at thePCT

South Staffordshire Primary Care Trust (PCT)serves a population of approximately 604,000and is located within the geographicalboundaries of Staffordshire County Council.The PCT employs just over 2,000 staff and itsturnover for 2007/08 was £725 million.

The geographical area of the PCT is largelyrural but contains a number of urban centresincluding Burton upon Trent, Cannock,Lichfield, Rugeley, Stafford, Tamworth andUttoxeter.

The PCT was established in October 2006,when the four former PCTs, Burntwood,Lichfield and Tamworth, Cannock Chase, EastStaffordshire and South Western Staffordshire,were merged.

On its website, the PCT described its approachto providing healthcare as based on focusing onprevention; targeting resources where need isgreatest; working with partners on other factorswhich impact on ill-health; and where treatmentis needed, offering choice and commissioninghigh-quality services with no delays.

The PCT, as part of its commissioning ofpatient services, was the host commissionerfor Mid Staffordshire NHS Foundation trust,taking the lead role in commissioning servicesfrom the trust on behalf of other PCTs whosepatients also receive services from the trust.

Staff from the PCT involved in commissioningtold us that they inherited a chaotic situation,with no detailed handover from the previousPCTs that had merged to form the new PCT.They were aware that the relationship withtheir predecessors and the trust had beendifficult with regard to the contracts betweenthem. Access to data and information aboutservices was reported to be difficult.

The minutes of the PCT’s performance andfinance committee did not reveal any evidencethat the PCT was aware of any problems in thequality of service being provided by the acutetrust prior to the Healthcare Commission’sannouncement of its investigation.

Commissioning had not inquired in any depthinto specific aspects of the quality of carebeing provided. A number of projects wereunderway to redesign various pathways ofcare, for example for patients with diabetes,and in November 2007 there was a project inA&E. The general consensus of those that wespoke to was that, prior to the investigation,there had been little information, includingfrom GPs, that care was not sufficient.

There had been aspects of monitoring of thequality in the service level agreements. Theseinvolved the processes for handlingcomplaints and the trust’s performance inrelation to targets regarding cancelledoperations and appointments and waitingtimes in A&E.

We were told that such quality monitoring isnow the subject of a national piece of work inthe NHS.

With regard to A&E, the PCT were not awareof the problems of having a single A&Econsultant, or the problems with therecruitment and retention of middle gradedoctors and A&E nurses.

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The role of other agencies

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The PCT told us that it had gained assurancefrom the trust’s performance in the annualhealth check of NHS trusts. The PCT alsoconsidered that the trust and its activitieswere the subject of scrutiny as part of itsapplication for foundation trust status. Withregard to the HSMR figure published by DrFoster in 2007, the PCT agreed with theactions being taken by the SHA as it did notfeel that it had the expertise to undertake itsown study.

All of the senior staff at the PCT that we spoketo recalled that finances in the NHS generallywere challenging in the year that the trustmade savings. The chief executive of the PCTwas not in post at the time but wassubsequently informed that the trust hadachieved a saving of £10 million. The PCT hadnot been alerted that the savings could haveaffected the quality of care provided.

Prior to the announcement of the HealthcareCommission’s investigation, the chiefexecutive of the PCT had personally visited GPsurgeries in the PCT and had asked about thequality of care delivered by the acute trust.Nobody had raised any serious concerns apartfrom the problem of delays in receiving clinicalletters from the trust.

Some GPs had participated in a pilot schemeto support discharge from the A&Edepartment at the trust. In addition, from April2008 a GP out-of-hours primary care centreservice commissioned by the PCT had been onthe same site and just yards from the A&Edepartment at the trust. However, the PCTwas unaware from these sources of anyproblems in the department.

Just prior to the Healthcare Commission’sinvestigation, the PCT’s chief executive cameinto contact with the ‘Cure the NHS’ campaigngroup when representatives attended one ofhis regular open meetings. Clinical staff fromthe PCT supported by the PALS teamsubsequently met with 15 individuals andacted as advocates for them to help resolvetheir complaints.

In addition, the PCT then contacted its twolocal commissioning groups to ascertain the

views of GPs on standards of care. Theresponses were highly critical and furtherraised the concerns of the PCT. The PCTcarried out an unannounced visit to the acutetrust in April 2008 to check for themselves thestandards of care. During the visit, the teamfrom the PCT visited both the trust’s A&Edepartment and a number of wards. The PCTensured that an action plan was immediatelyput in place to address staffing shortages andclinical leadership in the short term.

In April 2008, the board of the PCT received areport from its lead director of quality andperformance regarding the Commission’sconcerns about the trust. The minutesrecorded that the PCT’s board had previouslybeen told about the review of the nursingestablishment and skill mix at the trust. Theminutes highlighted the concerns the PCT hadlearned from the local campaign group, thecommissioning consortia and theunannounced visit it had undertaken.

The PCT agreed to provide some additionalfunding to the trust to support a number ofshort-term initiatives to improve quality,including employing additional senior nursingstaff in the A&E department. The amount thatit agreed to fund was less than the trust hadrequested, as the PCT suggested that the trustused the internal reserves it had generatedthrough its planned surplus.

Ongoing mechanisms for monitoringimprovements since the beginning of theHealthcare Commission’s investigationincluded involvement in an action plan toimprove standards of nursing care, monthlycommissioning meetings where complaintsand serious untoward incidents were detailedand the A&E Improvement project, which wasinitiated after the Healthcare Commissionraised its concerns about the department.

The PCT also set up and extended the pilot GPservice in A&E to help divert patients waitinginappropriately for treatment.

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West Midlands Strategic HealthAuthority

Sources of evidence

• Minutes of meetings of West Midlands andformer SHAs

• West Midlands SHA timeline of events

• Email correspondence

• Interviews with senior staff from the WestMidlands and former Shropshire andStaffordshire SHAs

Strategic health authorities (SHAs) wereoriginally created in 2002 to manage the localNHS on behalf of the Secretary of State forHealth. Each SHA is responsible fordeveloping a strategic framework for the localhealth and social care community, and

managing the performance of providers ofhealthcare in the NHS within its geographicalboundaries. This includes putting and keepingin place arrangements for monitoring andimproving the quality of healthcare provided toindividuals in the area.

The trust was part of the Shropshire andStaffordshire SHA until the summer of 2006.Following the reorganisation of SHAs in July2006, the trust became part of West MidlandsSHA.

The SHA relinquished the aboveresponsibilities in relation to the trust when itattained foundation trust status in February2008. From that point, Monitor assumedongoing responsibility for managing theperformance of the trust.

The senior staff from West Midlands SHA thatwe spoke to told us that there had not been aformal or comprehensive handover ofinformation and intelligence from thepredecessor organisations and organisationalmemory had therefore been lost. A formerdirector of finance who had worked at one ofthe predecessor SHAs told us that he had lefthandover information about financial issues.The current SHA was able to provide us with acopy, and the matters are detailed later in thissection.

The general perception of the SHA regardingthe trust was that, unlike some other trusts inits area, it did not have information to suggestthat there were concerns relating to thequality of care that it provided. As with thePCT, the SHA was aware that the trust hadapplied to become a foundation trust and wastherefore subject to scrutiny in this regard.

The minutes of the board meeting of theShropshire and Staffordshire SHA inNovember 2004 noted that a £18 million deficitwas forecast for the SHA for the full year. TheSHA announced the development of robustrecovery plans including incentive schemes fortrusts that were under-spenders andincreased reporting for over-spenders. Theforecast deficit for 2004/05 was estimated tobe £39.5 million, according to the minutes ofthe SHA board in July 2005.

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• There was a lack of information handedover from the predecessor PCTorganisations regarding services providedby the trust.

• Neither the commissioning process norother sources of information indicatedconcerns about the quality of careprovided to patients at the trust.

• The financial situation was known to havebeen challenging.

• The PCT had been assured by the trust’sratings in the annual health check and itsapplication to become a foundation trust.

• The PCT became aware of concerns at thesame time that the HealthcareCommission raised concerns.

• The PCT responded to the concerns of the‘Cure the NHS’ group and acted as anadvocate to help resolve their concerns.

• Since becoming aware of the concerns, thePCT has provided practical and resourcedsupport to the trust, particularly in thearea of A&E.

Findings of fact

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In October 2005, it was recorded in the trust’shospital management board minutes that thefinancial position of the SHA was dire. InMarch 2006, the minutes of the trust’s hospitalmanagement board stated that the worst-casescenario was a £370 million deficit for theSHA. The minutes recorded a 2% top slice ofthe allocation for PCTs and a further 1% on adifferential basis had been discussed at thechief executives’ meeting in February. Thechief executive of the trust stated that this wasa serious position and plans needed to be inplace. The trust subsequently initiated action,as discussed previously in this report, toremove beds and reconfigure wards, and toremove 150 posts at the trust.

Staff that we spoke to from the current andformer SHAs confirmed that finances weredifficult in 2006/07, as they were generally inthe NHS. Previously the trust had made smalldeficits and surpluses but none of them couldrecall the SHA explicitly requiring the trust tomake a £10 million saving. We were told that asaving of this order would have represented anon-achievable sum in relation to the trust’sturnover. The current SHA has informed theHealthcare Commission that the former SHArequired the trust to make a saving of 3.5% ofits turnover, which was £125 million. The 3.5%was the combination of the NHS efficiencyrequirement of 2.5% and 1% towards repayingtheir deficit. Anything in addition to this wouldhave been an internal trust decision, toaddress cost pressures and its underlyingdeficit.

Handover information provided to the new SHAfrom the director of finance at the Shropshireand Staffordshire SHA detailed the previousfinancial performance of the trust as outlinedabove. With regard to the 2006/07 financialplan, it noted that the acute and primary caretrusts in the former Shropshire andStaffordshire SHA anticipated revenue deficitsof £4.7 million and £5.6 million respectively(£10.3 million collectively). The trustanticipated a surplus of £1 million that,together with other similar amounts for othertrusts, had already been used to offset whatwould have been a greater deficit for all of the

acute trusts. The current SHA told us that theprevious SHA planned to balance the deficitsby savings at the SHA.

Following publication of the Hospital Guide byDr Foster Intelligence in April 2007, whichlisted six trusts within the West Midlands SHAregion as “poor performing” in terms of theirhospital standardised mortality ratios, the SHAcommissioned academics from the Universityof Birmingham to undertake research andproduce a report to determine whether thepoor results were a consequence of poorcoding. One of these six was the trust.

Before deciding to commission the research,the SHA called the chief executives of the fivetrusts that were not foundation trusts to ameeting to determine what actions the trustswere undertaking. During that meeting, itemerged that there was a variable approach toclinical governance, with a general lack ofsystematic approach to clinical audit,management of serious untoward incidents,complaints, and the use of benchmarkinginternally of clinical indicators on a regularbasis. It was not clear how much engagementthere was at board level. It was made clear tothe chief executives that the SHA would beexpecting early remedial action from thetrusts. The SHA was assured by what the trustinformed them and therefore concentrated itsattention on others where they felt lessconfident and where the performance reportedby Dr Foster Intelligence was of more concern.

One way that SHAs undertake their role inperformance managing providers ofhealthcare services and being aware ofpotential patient safety concerns is by knowingabout serious untoward incidents (SUIs) thatoccur. In the board minutes of Shropshire andStaffordshire SHA in February 2005, it wasnoted that further work needed to take placewithin local NHS organisations to improve thereporting arrangements for SUIs, and inparticular the need to share learning gainedfrom investigating them.

In November 2007, a continuing lack ofconsistency in reporting was noted in thatsome trusts were reporting SUIs to the

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National Patient Safety Agency and not to theSHA and vice versa. It was noted that therehad been a degree of variety of types of SUIsreported. SUIs in foundation trusts have to bereported to the relevant PCT as well as toMonitor and SHAs can access informationthrough their performance management ofPCTs. Since early 2008, all SUIs in all truststhat relate to infections have to be sent to the SHA.

In April 2008, a revised SUI policy wasintroduced. Staff from the SHA informed usthat further work was underway regardinghow best to learn from SUIs.

In March 2005, a report to the Shropshire andStaffordshire SHA board on healthcareacquired infections noted an escalation of theSHA‘s performance management approach tothese infections and emphasised that the SHAwould not take on responsibility of individualorganisations. In May 2006, the director ofperformance and finance reported on hospitalcleanliness, citing Burton Hospital as a poorperformer in relation to MRSA and stated thatperformance at Stafford hospital was aboutthe same. Unlike Burton, Stafford was notrequired to produce an action plan as theywere able to articulate clearly to the SHA howthey were addressing the matter.

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• There had been no formal orcomprehensive handover of informationfrom the predecessor organisations to thenew SHA following reorganisation, andintelligence about the trust was primarilylimited to financial matters.

• The SHA was not aware of any concernsregarding the quality of services providedby the trust before Dr Foster Intelligencepublished its Hospital Guide in April 2007.

• Although overall there were financialpressures in the SHA, the SHA did notrecall insisting that the trust makesavings of £10 million in 2006/07.

• The SHA commissioned the University ofBirmingham to undertake research intothe findings in the Dr Foster HospitalGuide 2007.

• The SHA was assured by what the trusttold them it was doing in relation to the Dr Foster report and healthcare-associated infections.

Findings of fact

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123Investigation into Mid Staffordshire NHS Foundation Trust

This section of the report brings together ouroverall assessment of the areas covered in theterms of reference. It is based on our findingsin the report. We address the questions thatare key to understanding what happened topatients admitted as emergencies at the trust.

What was the experience of patientsand relatives at the trust?When we announced the investigation we hadan unprecedented response, with 103 relativesand patients contacting us. Of these, 99 werecritical or had had a poor experience. Themain areas of concern were A&E, theemergency assessment unit and medicalwards 10, 11 and 12. Concerns were alsoexpressed about some surgical wards. A majorconcern was poor standards of nursing care.

Although we recognise that this was not astatistically representative sample of patientsand relatives, their concerns reflected what wefound through observations, case notereviews, complaints and interviews –disorganisation, delays in assessment andpain relief, poor recording of important bodyfunctions, symptoms and requests for helpignored, and poor communication withpatients and families.

In the Healthcare Commission's 2007 surveyof inpatients (the latest national surveyavailable), the trust was in the worst 20% for39 out of 62 questions, and the in the best 20%for two questions. This was a poor result. Thetrust was in the worst 20% for overallstandards of care and whether patients feltthey were treated with respect and dignity inthe hospital.

Did the trust have a high mortality rate?The trust’s mortality rate for patients agedover 18 admitted as emergencies had beenhigh since 2003. If outcomes were the same aswould be expected for other similar trusts, thestandardised mortality ratio would be 100. Thevalue for the trust varied from 127 to 145 forthe three years covered by the investigation.The crude mortality rate was also significantlyhigh for the same three years.

The mortality was found to be high across arange of conditions (analysed by the standardsystem of healthcare resource groups),including those involving the cardiac system,vascular system, nervous system, respiratorysystem, haematology and infectious diseases.This strongly suggested that there weresystemic problems across the trust’s entireemergency care system, rather than beingconfined to one area or specialty.

Did the trust have adequatearrangements for collecting andanalysing data and for responding tohigh mortality rates?The trust had a long history of poor qualityinformation about its services. Since thesummer of 2007, the coding of clinical datahad improved. However, it was still difficult, ifnot impossible, to match information betweensystems. In part, this was due to the poorsystem for recording activity in theatres. Datathat we had from different sources, such asthe theatre log and national Hospital EpisodeStatistics data, could not be reconciled. Whenchallenged, neither the trust nor individualconsultants could produce an accurate recordof clinical activity or outcomes for patients.This meant we could not analyse the volumeof surgical work and its outcomes.

Conclusions

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The trust’s response to alerts about highmortality was inadequate. The trust assumedthat the raised mortality was primarily due topoor coding of information, but could notsubstantiate its claim. The trust established agroup to investigate mortality. It did this bylooking at samples of the case notes of patientswho had died. However, the reviews were notsystematic and were not robust. The defaultposition appeared to be that the deaths hadbeen inevitable and there were no problemswith the care of the patients. Although our casereviews were undertaken on a small scale, theythrew significant, and troubling, light on theclinical quality and governance arrangementsprevailing in the trust. We found that there hadbeen problems with care that had not beenidentified, and the trust had missedopportunities to learn lessons.

What did we find out about the care ofpatients admitted as emergencies?

The A&E department

Most patients admitted as emergencies comefirst to an accident and emergency (A&E)department. Such patients should expecttimely and thorough assessment by trainedand skilled staff, followed by an appropriateplan of care. In the trust, patients arrived at adepartment that was poorly led, understaffedand poorly equipped.

The position when the Healthcare Commissionvisited the department in May 2008 was soworrying that we asked for an urgent meetingwith the chief executive to raise our concerns,and we followed this up immediately with aformal letter requiring urgent action.

The department had been refurbished in thesummer of 2007. This had improved itsappearance, but an opportunity had beenmissed to improve the function of thedepartment. The layout meant that it wasdifficult for staff to see patients in the waitingroom. The view from the reception desk waslimited and this was especially worrying as thereceptionists were relied upon to observe thepatients. This was despite one of the objectives

in the project plan for the refurbishment beingbetter visibility of patients.

The department lacked many items ofequipment including trolleys, cardiac monitorsin the resuscitation bays, sufficient lighting andportable suction. Access to CT scanning out ofnormal hours was difficult and sometimes ledto delays in diagnosis and treatment.

Administrative staff in reception assessedpatients (other than those arriving byambulance) because there were too fewnurses to perform triage. These staff did nothave any qualification or training for this task.We were given examples of patients who hadbeen adversely affected by the lack ofadequate assessment. Many patients waitedfor hours with no pain relief, observations,dressings or antibiotics.

There was a longstanding shortage ofconsultants in emergency medicine in thedepartment. This was exacerbated by theturnover of managers. When we visited in May2008, there was only one consultant in postwhen there should have been at least three. Itwas only possible to have consultant cover fora maximum of 12 hours per day. This was acompletely unacceptable situation.

The trust mistakenly treated as interchangeablethe roles of acute physicians and consultants inemergency medicine, and the acute physicianswere asked to cover aspects of A&E that wereoutside their professional competence. This wasunacceptable.

There was also a longstanding shortage ofmiddle grade doctors. For two weeks inOctober 2006, there was no consultant ormiddle grade cover between midnight and7am on weekdays. This was also unacceptable.

The shortage of consultants and middle gradedoctors meant that junior doctors were notadequately supervised or supported, which putpatients at risk. For some months in 2008,there was virtually no educational activity andteaching sessions were frequently cancelled.The lack of leadership, feedback onperformance and opportunities to develop leftthe junior doctors demoralised, frustrated and

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concerned. Junior doctors rarely receivedfeedback on their performance.

There was also concern that, in order toachieve the target that no patient should waitmore than four hours in A&E, junior doctorswere frequently put under pressure to makerapid decisions to discharge or to admit. Thiswas especially unfortunate, as the doctors intraining were not adequately supported inmaking these decisions.

Many staff considered that the focus on thefour-hour target led to a distortion of clinicalpriorities, as on occasions doctors were askedby managers to stop treating seriously illpatients in order to see and treat patients withminor ailments.

There was also a shortage of nurses in thedepartment and a worrying deficit in seniornurses and senior nursing leadership. Nursingstaff were concerned about their capacity toobserve and monitor patients, and deliverminimum standards of care. Few nurses hadundertaken any nationally recognised coursein A&E nursing.

Sometimes, patients were moved from A&E tothe emergency assessment unit without aproper plan of care, which resulted in delaysin patients receiving fluids and antibiotics.Sometimes patients with injured limbs weremoved to wards before they had been x-rayed.

On other occasions, patients were moved tothe small clinical decision unit in order to ‘stopthe clock’. This area did not have a formalallocation of staff, as A&E nurses were meantto cover it. Since there was often a shortage ofstaff, particularly at night, patients in this areawere not properly monitored. Some of thesepatients were quite unwell and we concludedthat it was not a safe environment for thesepatients. Again, this was unacceptable.

There were few protocols or guidelines in usein the department. There was no regularclinical audit. When audits were completed bydoctors as part of their training, the resultswere not acted upon, even if they showed anunsatisfactory clinical situation.

There were no meetings to discuss mortalityor morbidity (that is, complications or adverseconsequences of treatment) within thedepartment, and hence to gain feedback onthe quality of care. There was no systematicmonitoring of patients who had to returnbecause they should not have been sent homein the first place.

There was no formal discussion of seriousincidents, even though some of these wereexamples of repeated errors, such as theadministration of penicillin to patients whowere allergic to it.

Therefore, we conclude that the A&Edepartment was fraught with hazards forpatients. It had too few staff, who wereinadequately trained and poorly led, with apoorly designed environment and lack ofequipment. The focus on the four-hour targetoften meant that doctors were moved fromtreating seriously ill patients to those withmore minor ailments. There was no effectivesystem for governance in the department.

The emergency assessment unit

The capacity of the emergency assessmentunit (EAU) had not been planned with anunderstanding of the demand for emergencyadmissions. The unit in the trust was unusualin that it took surgical, trauma andgynaecology patients as well as medicalpatients. However, it did not have appropriatestaffing or equipment for these patients.

Until May 2008, it was a large unit, with 48beds and a dysfunctional layout. Eight bedswere far from the nurses’ station and could noteasily be observed. It was a noisy, busy place,frequently described by patients, relatives andstaff as chaotic. In 2007/08, it had performedpoorly in a trust audit for compliance with goodhand hygiene and infection control. Neither didit perform well in 2007 on an audit ofprevention of pressure sores.

Some patients were admitted to the EAU beforethey had been properly assessed in the A&Edepartment. Other patients had to remain in theEAU for longer than was desirable because ofthe lack of a bed in their specialty. This included

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patients who should have been in the acutecoronary unit.

The EAU did not have the recommended ratio ofone qualified nurse for every six patients. Thetrust’s plan to save money in 2006/07 resulted ina reduction in staff numbers. At the end of 2007,the nurse to patient ratio was close to one nursefor every 15 patients. This was clearlyinadequate for the many acutely unwell patientson the unit. The situation improved in May 2008,when 12 beds were removed from the unit andby July there was one qualified nurse for every10 patients.

The shortage of nurses compromisedcommunication with doctors and otherhealthcare professionals. Doctors said they oftencould not find a nurse who knew about theirpatients. Lack of communication was a frequenttheme in complaints about the unit.

Many patients and relatives told us aboutpatients not receiving basic care, such as help toeat and drink. Buzzers were not answered.Telephones often went unanswered. Manypatients did not receive the correct medication intime, or at all.

There was also concern that surgical patientsand those with traumatic injuries were not wellmanaged on the EAU, because the unit did nothave nurses with the right skills.

By May 2008, the unit had its full complement ofthree acute physicians. However, their inclusionin the A&E rota has already been criticised inthis report as inappropriate.

There was little training for nurses on the unit in2007/08 because of operational pressures on theservice. This deficiency included training in lifesupport and in July 2008 only one member ofstaff had a qualification in advanced life support.

We were particularly concerned that nursesdid not have the expertise to recognise when apatient’s condition was deteriorating, to readcardiac monitors, or to complete and interpretfluid balance charts. All of these deficits putpatients at considerable risk.

It was deeply worrying to us that nurses madesimple arithmetic errors in adding up the

scores for the modified early warning system(MEWS), supposedly designed to alert clinicalstaff to patients becoming seriously ill.Similarly, it was a very serious concern thatstaff responsible for patients in the bed spaceswith cardiac monitors on the EAU did notunderstand the monitors. On occasions, forthis reason, nurses turned off the monitors.This put patients at risk and wasunacceptable. We noted that the trust’s ownaudit in July 2008 found that a large number ofpatients on the EAU were succumbing tocardiac arrest. This suggests the importantneed for staff in the EAU to be competent inthe use of cardiac monitors.

Many doctors were worried that nurses did notcarry out observations of, for example,patients’ heart rates and blood pressure,frequently or thoroughly enough. This wasparticularly true at night.

Many patients did not have their fluid balanceadequately monitored and nurses were notusing the right equipment to ensure thatpatients received the correct amount ofintravenous fluid in the correct time period. Of20 infusions that we observed on one visit,only two were running on time. On subsequentvisits, more of the infusions that we observedwere running on time.

Overall, we found the EAU to be anotherclinical area that was full of hazards forpatients admitted there. There were too fewnurses and many of those that worked theredid not have the right skills, since they did notunderstand cardiac monitors and made errorsin identifying whether the condition of a patientwas deteriorating. A proper system for clinicalgovernance might have identified thesedeficiencies and sought resources to improvestandards of care, but this was not in place.

Medical admissions

The reconfiguration of medical wards, whichwere merged into ‘floors’, was associated witha reduction in the number of qualified nurses,particularly the more senior ward nurses. Forexample, until the summer of 2008, there wasjust one senior sister for the 78 beds on floor

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two. This clinical area, comprising wards 10, 11and 12, included many acutely unwell patientswith strokes, chronic respiratory conditionsand diseases of the digestive system.

There was considerable concern from doctorsand nurses that the number of nurses on floortwo was inadequate. The trust’s own review ofstaffing levels in 2007 identified a shortfall of77 nurses in medicine. The lack of nurses wascompounded by high sickness levels.

Staff had reported many instances of lowstaffing levels involving risk to patients, andthere had been many complaints from patientsand relatives. These were around buzzers notbeing answered, privacy and dignity beingignored and patients receiving little or no helpwith food or drink. Staff in other professionsraised concerns about the standards of basicnursing care, such as poor hydration andnutrition of patients. Staff and relatives werealso worried about the failure to ensurepatients received the correct medication.

Poor attention to the care of skin and pressurepoints meant that many patients developedpressure sores. An audit by the trust inJanuary 2008 found that 55% of 38 patients onward 10 had some degree of pressure damage.Only four of these patients had any pressuredamage when they were admitted to hospital.

Senior staff told us that many medical patientsended up on the “wrong” ward – for example,a patient with alcoholic liver disease could beon the respiratory ward. They would then belooked after by a respiratory physician, not agastroenterologist.

Care on the acute coronary unit was held inhigh regard by patients and relatives.However, we have already noted that manypatients with heart attacks did not come to thecoronary unit but remained on the EAU, wheremany nurses did not understand cardiacmonitors. There had also been a longstandingproblem with the cardiac monitors on theacute coronary unit. Although noted in July2007, the problem had still not been resolvedover a year later.

Stroke patients were always admitted first tothe EAU, although many staff thought this wasnot a good environment for these patients. Thetrust had only four beds, located on ward 10,dedicated to the care of patients with an acutestroke. This was not enough for the number ofpatients admitted with a stroke. The trust didnot meet the criteria for an acute stroke unit.Nor did it meet the guidance of the RoyalCollege of Physicians that imaging of the brainshould be undertaken within at least 24 hoursof onset of a stroke. The mortality rate forpatients with stroke at the trust was above theEuropean average. There were also concernsabout the basic care provided to some patientswith stroke, including poor mouth care andinadequate help with feeding and drinking.

Unlike over 90% of trusts, the trust did nothave facilities for non-invasive ventilation onthe medical wards, even on the respiratoryward. This was despite the recommendation ofthe National Institute for Health and ClinicalExcellence. Non-invasive ventilation is ameans of supporting breathing, using a maskor similar device. Since there were often nobeds on the critical care unit, some patientswho needed it did not get this important typeof care.

The trust failed to ensure that resuscitationtrolleys were always appropriately stocked. InFebruary 2008, we found a trolley on a wardthat had not been checked since July 2007 andthat contained some items that were out ofdate. The trust explained that this was not theresuscitation trolley used on the ward.However, this was of particular concern, giventhe incident in September 2006 when a patientwas mistakenly given an infusion that shouldnot have been on the trolley. The patient wasseriously ill and the error occurred duringattempts at resuscitation. The uncheckedtrolley could have been confusing, particularlyto agency staff.

The availability of portable suction equipmenthad been limited in the trust. Most bed spaceshad suction as part of the permanentequipment available. However, patients couldrequire resuscitation in locations other thanthese beds. We also noted that the bleep

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system for cardiac arrests had beenunavailable on a number of occasions. Thismeant the cardiac arrest team would not beaware of a cardiac arrest and would notrespond. A contingency plan of using mobilephones was adopted.

Emergency surgical admissions includingthose with traumatic injuries

Care for patients admitted as surgicalemergencies was not generally provided inline with agreed protocols.

Many staff had concerns that the nurses onthe emergency assessment unit did not havethe skills to look after surgical patients orthose with traumatic injuries. Because of alack of surgical and trauma beds, thesepatients might also be sent to medical wards.Again, it meant that patients were not alwayscared for by nurses who understood theirconditions and had the necessary skills orequipment, for example to establish lowerlimb traction.

There had been a period when traumapatients were located between wards 6 and 7,on floor one, in a “no man’s land”. At this timethere was no reception area, no nurses’station, no telephone, and no access to acomputer. The layout meant that some bedscould not be observed. We noted that it was inthis location that a serious untoward incidenthad occurred.

There was inadequate cover by doctors forsurgical patients at night and weekends. Therewas just one foundation year one doctor (themost recently qualified) to cover all thesurgical patients on the wards. The mostsenior doctor to cover admissions for surgeryafter 9pm was the resident surgical officer.Some of the resident surgical officers wereinexperienced. The only support they had wasfrom a consultant on call from home. Althoughthe consultants were available to be called,some doctors in training admitted they hadleft patients to the morning rather than callthe consultant at night.

At weekends, there was only one emergencyoperating list per day. There was no system to

prioritise cases for the emergency theatre list.Priority was generally given to generalsurgical patients or obstetric cases, whichmeant that patients with traumatic injuriesoften did not get operated on at weekends. Weheard many examples of where patients withbroken hips had their operations cancelledseveral times, sometimes resulting in a delayof several days. The guidance is that suchpatients should be operated on within 24hours. In the trust’s own review of patientswho had died, the lack of availability ofemergency theatre time was considered to bea factor contributing to some deaths. Similardelays occurred for patients with otherfractures of long bones.

When patients had to wait for their operations,often being scheduled and then cancelled,their drugs, fluids and food were stopped forquite long periods. Thus, a patient might haveto experience three or four days in a row ofbeing ‘nil by mouth’ for most of those days. Wenoted an instance of a patient who died, whohad not had their medication for their heartproblem for three days prior to their operation.

There had been concerns for at least threeyears about the inefficiency and under-utilisation of theatres. There had been a highturnover of theatre managers and highsickness levels among theatre staff. The poorinformation available about the number ofoperations performed and the outcomes ofthese operations meant we could notundertake further analysis about the volumesof specific surgical procedures.

On occasions, staff failed to identify that thecondition of a patient was deteriorating aftersurgery. This meant that some complicationsof surgery were missed or only identified aftera delay, with serious consequences forpatients. The lack of regular review of suchcases also meant that opportunities forlearning were lost.

The trust had failed to implement an effectiveand consistent system of preventing bloodclots in the veins of the legs and pelvis. Whensuch clots dislodge, they can cause fatalobstruction to the blood flow to the lungs. Thisis a common and largely avoidable cause of

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death in patients in hospital. We noted thefrequent occurrence of deep venousthrombosis and pulmonary embolism in casenotes and the reports of inquests. Althoughconcerns about this had been expressed at thehospital management board in October 2005,it was clearly still a problem nearly threeyears later. An audit presented in September2008 showed that only 30% of patients hadbeen given an anticoagulant in accordancewith the trust’s protocol.

The relief of pain was also an area thatgenerated complaints and where there hadbeen little if any improvement.

Relatives and patients were generallycomplimentary about the critical care unit.However, at times there were too few staff toopen a sufficient number of critical care beds,and some confusion and tension about accessto medical advice from critical care.

What were the reasons for the failingsat the trust? It is the view of the Healthcare Commission thatthere were deficiencies at virtually every stageof the pathway of emergency care.

When patients arrived in A&E, they wereusually assessed by reception staff with noclinical training, before waiting in an area outof sight of the staff in reception. There was noregular check by nursing staff of the patientsin the waiting room. Some essentialequipment such as cardiac monitors wasmissing or not working.

There were too few doctors and nurses, andpoor training and supervision, and juniordoctors were pressurised to make decisionsquickly without the advice and support frommore senior doctors. Doctors were movedfrom treating seriously ill patients to deal withthose with more minor ailments in order toavoid breaching the four-hour target. Patientswere moved to the clinical decision unit to‘stop the clock’, but were then not properlymonitored since this area was not staffed.Patients had to wait for medication, pain relief,wound dressings and antibiotics. There was

only a relatively junior doctor available after9pm to give advice on surgical patients. Therewas no specialist trauma team. In summary,the care and assessment of patients fell wellbelow acceptable standards.

Sometimes patients were rushed to theemergency assessment unit without properassessment or discussion and withoutappropriate specialist care.

The emergency assessment unit was a verylarge ward with a poor layout. It was busy,noisy and sometimes chaotic with too fewnurses. Many of the nurses did not understandthe cardiac monitors and did not always carryout observations adequately to identify if apatient’s condition was deteriorating. Therewere many instances of patients not receivingthe medication they needed.

There were too few stroke beds, not allpatients with heart attacks went to the acutecoronary unit, there was no non-invasiveventilation on the respiratory ward, and criticalcare beds and support were not alwaysavailable. The medical wards on floor twowere seriously understaffed and there weregrave concerns about the standards of nursingcare.

There were too few theatre sessions atweekends and consequent delay in getting totheatre, especially for trauma patients, andsome patients did not get essentialmedication. Post-operative complications werenot always recognised.

Surgical practice was idiosyncratic,relationships were poor and there was littlemultidisciplinary team work. There wereconcerns about the level of medical cover atnight and at weekends. We identified manyinstances, in the areas we considered, of thelack of timely review by a senior doctor.

Across the trust there were shortcomings inresuscitation and arrangements to avoidpotentially fatal blood clots were inconsistent.

It is our view that all these factors would havecontributed to a poor outcome for patients.

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What arrangements did the trust havefor the prevention and control ofhealthcare-associated infections? The patients and relatives who contacted uswere very critical of standards of cleanlinessand hygiene at the trust in 2006 and 2007.They provided us with graphic examples of adirty environment and sloppy practice. InAugust 2007, the committee arrangementswere changed and the chief executive chaireda steering group for infection prevention andcontrol. The director of nursing also becamethe director of infection prevention and control(DIPC). In 2008, following these changes, theprevention and control of infection improved.

For at least three years, there was no publicrecord of infection control in the form of anannual report until one was put on the trust’swebsite in April 2008.

In early 2006, there was a doubling of the rateof C. difficile infection, strongly suggestive ofan outbreak. The infection control teamisolated infected patients and improvedcleaning, but the outbreak was not reported tothe strategic health authority nor to the trust’sboard, and therefore the public was unawareof it. A report by the trust some months laternoted the lack of isolation of patients,inadequate cleaning of commodes and bedpanholders, delay in sending samples to test forC. difficile, poor communication betweenhealth professionals, and delay incommencing treatment for symptomaticpatients. None of these deficiencies weredrawn to the attention of the trust’s board.

The trust did not publicise information aboutthe number of cases of C. difficile. The trusthad been slow to control the prescribing ofantibiotics. This was not compliant with goodpractice and there were no regular audits ofpractice.

Since the end of 2006, the rates of C. difficileand MRSA had declined. The control andprevention of infection had improved in 2008following the establishment of the steeringgroup and the appointment of the new DIPC inthe previous year. The trust was inspected inOctober 2008 and judged to be meeting the

duties in the Government’s hygiene code. Thetrust deserves credit for this.

What governance arrangements did thetrust have to monitor and improve itsservices?In March 2006, the trust’s board decided that,in future, reports on governance would comeonly to the private meeting of the board.Neither the chairman nor chief executivecould explain this decision.

We have noted the almost complete absenceof governance in the A&E department, whichwas part of the medical division. We havecommented on the longstanding awareness ofproblems in the department and the failure totake effective action.

In surgery, there was no effective governancestructure or audit process, and in at least onespecialty consultants had no agreed commonprotocols. There were poor relationshipsbetween the general surgeons, and littlemultidisciplinary team work. This hadinhibited the development of commonprotocols and agreed ways of working. Therewas little information available about thevolume and outcomes of specific operations.The surgeons had a poor record of attendanceat divisional governance meetings.

There were no meetings in the medicaldivision to discuss mortality and morbidity(that is, complications or adverseconsequences of treatment). In surgery, therewere some meetings, involving only doctors, todiscuss audit results and mortality andmorbidity, but these were not minuted, andthere was no systematic way for findings to beshared or lessons learned.

Overall, we considered that the approach ofthe mortality group to reviewing patients whohad died was not sufficiently systematic orrobust. This meant that important failings,such as lack of early review by a senior doctor,were often missed. Even if they identified thatsomething had gone wrong and needed to beaddressed, this did not necessarily happen.Thus, although the mortality group hadidentified in October 2007 the concern about

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failure to give essential medication to ‘nil bymouth’ patients, a year later no effectiveaction had been implemented to prevent thishappening again.

Clinical audit should improve the quality ofcare through review of achievements againststandards and making changes wherenecessary. The trust did not have a consultantwith lead responsibility for clinical audit for ayear and the trust-wide group did not meet atall during this period. When audits werecarried out, there was no robust mechanismto ensure that changes were implemented.There was little effective clinical auditundertaken in the medical or surgical division.When re-audits were required, they were oftennot undertaken, even if they had beenrecommended by a Royal College. The trustdid not participate in many of the specialistnational audits run by the specialist societies.

We were concerned that the trust made anumber of errors in the returns to theCommission for its review of urgent care, andthat some reports to the board andcommittees were inaccurate or incomplete.

Were doctors actively engaged withgovernance and the business of the trust?The chief executive told us that there had beenconsiderable efforts made to engage withclinical staff and felt that progress had beenmade. However, we found that many seniordoctors were disillusioned, since theyconsidered that the trust had not heeded theirconcerns about the impact of the clinicalfloors programme, the lack of staff in A&E orthe £10 million cost savings in 2006/07. It wasnotable that the trust did not have asubstantive director of nursing or medicaldirector in place for much of 2006.

Many consultants that we spoke to consideredthat the trust’s decisions were driven primarilyby financial considerations. Although theyacknowledged that the trust now had a cleardirection, many felt marginalised because ofthe trust’s inflexible ways of imposing change.

Some appeared to have given up expressingtheir views, since managers were said todislike critical comments and to ignore them.

Although most non-clinical staff told us thatcare at the trust was good, the majority ofdoctors would not have been happy for arelative to be treated at the trust. In thenational survey of NHS staff in 2006, only 27%of staff said they would be happy with care atthe trust, compared to 42% nationally.

Worryingly, many consultants considered thatgovernance at the trust was something thatwas done to them, rather than being a keypart of clinical activity in which they had amajor part to play. A symptom of this was theinsistence by one senior doctor that meetingsto discuss, for example, unexpected deaths,were for professionals only and were not partof governance. Since clinical governance hasbeen in existence for over 10 years, this was asignificant concern. The poor relationshipsbetween the consultants in general surgeryand the lack of teamwork were also worrying.

Did the trust have appropriatearrangements to identify and manage risk?The trust had poor arrangements to managerisk. Items appeared on divisional riskregisters from one year to the next withoutresolution and it appeared that the trustexpected the divisions to manage someproblems that were trust-wide, such as lowstaffing levels.

We have noted the failure in the medical andsurgical divisions to resolve problems such asnil by mouth, cardiac monitors, the cardiacbleep system, portable suction, antibioticprescribing and preventing blood clots andpulmonary embolism. Often these issues werelisted on the corresponding risk register, butno effective action had been taken.

The trust had a high rate of complaintscompared to other trusts and also highnumbers of patients and relatives who weredissatisfied with the trust’s response.Managers did not appear to be aware of these

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signs of systemic problems. The investigationand handling of complaints was poor and,when action plans were produced, action oftendid not follow. No mechanism existed for theboard to ensure such commitments were met.

The routine reports on performance that wentto the board were so ‘high level’ that they didnot identify the failings in care of patients. Theinformation presented to the board oncomplaints was often incomplete or sosummarised that it left non-executives at adisadvantage in being able to perform theirrole to scrutinise and challenge on issuesrelating to patient care. The trust’s boardnever looked at any individual complaints,even when serious, which meant they missedout on this important way of learning aboutthe experience of patients and theaccompanying insight into actual practice.

Even the combination of serious complaints,staff saying they would not be satisfied withcare at the trust and poor results in thenational patients’ survey, did not persuademanagers and the board that standards ofcare were poor, or at least merited theirattention and careful scrutiny. The trustmissed other opportunities to learn from errors unearthed at inquests or during litigation.

Staff had little confidence that reportingincidents achieved change and the evidencewe saw confirmed they were correct. We wereconcerned that many serious incidents werenot reported as such or adequatelyinvestigated. Problems identified at inquestswere not investigated further. Some types ofserious incidents had been repeated, forexample patients absconding, patients givenincorrect infusions, and patients given drugsto which they were allergic. We have notedproblems related to resuscitation. At board level, there was little focus on theinvestigation of incidents and subsequentlearning.

Responsibility for dealing with complaints andincidents had largely been devolved to thedivisions, but the trust did not monitor this.

What was the trust’s approach tonursing and nurse staffing levels?Many nurses told us that there had been littlesupport for nurses and their development forsome time, but that this had improved morerecently with the arrival of the new director ofnursing and the recruitment of more staff.

In 2002, the independent review of clinicalgovernance at the trust by the HealthcareCommission’s predecessor, the Commissionfor Health Improvement, reported that staffinglevels were a cause for concern, particularly innursing. In 2005, the trust had many wardswith below average number of nurses.

The combination of the programme to createclinical floors and the decision to makeextensive savings in 2006/07 led to a reductionof the number of nurses in post and theproportion of senior nurses. Additionally, inpart because of the lack of staff, there was aserious shortfall in training.

The total number of nurses declined from2,359 in April 2004 to 2,157 in April 2008. Thenumber of nurses per bed also fell between2006 and 2008. There were only three matronsfor the entire trust. The loss of confidence andmorale led to a further loss of skilled andexperienced nurses.

The trust did not reinvest in staff in 2007/08,despite declaring a financial surplus in2006/07, and despite information that couldhave been extracted from complaints, surveysand incidents that there were too few nursesand that this was having an adverse effect onthe care of patients. The trust has told us thatthe surplus had to be used to repay brokerageto the PCT.

A review of the skill mix and numbers ofnurses took place in the autumn of 2007. Itfound an overall deficit of 120 whole-timeequivalent nurses. Recruitment began inJanuary 2008, although the board did notapprove the expenditure until the end of March2008, after the announcement of thisinvestigation. At least 12 months had elapsedbetween the formal recognition of a seriousproblem and the board sanctioning remedial

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action. The problem was compounded becausein at least two areas, A&E and floor two, theproblems were widely recognised and meritedaction ahead of the outcome of a complexreview process.

The culture of the organisation, thetrust’s board and its prioritiesThe clinical governance review in 2002 advisedthat the trust needed to develop an openculture, but we did not gain an impressionfrom staff that this had happened, or thatconcerns were welcomed and could bediscussed and resolved. In the 2007 nationalsurvey of NHS staff, the trust came in theworst 20% for staff reporting bullying by othermembers of staff.

The information about the outbreak of C. difficile in 2006 was not shared with theboard or released to the public.

The leadership operated a closed culture. Thetrust’s board clearly preferred to conductmuch of its business in private, includingmuch that would be discussed in public inother trusts. Poor results from the nationalstaff and inpatient surveys were not discussedat public meetings of the board. Much of theroutine business of the trust that wouldnormally be discussed in public meetings wasonly considered when the board met in privatesession. This included annual reports oninfection control and the hospital standardisedmortality ratio.

Most staff considered that the board had aclearer direction with the chairman and thecurrent chief executive. We noted that much ofthe discussion at the board was dominated byfinance, targets and achieving foundation truststatus. It had at least two ‘away days’ todiscuss becoming a foundation trust. In 2007,the board allocated considerable time todiscuss reports on marketing and competitionwith neighbouring trusts. For example, in theminutes of the board meeting in May 2007, thediscussion on marketing covered a page, butthe corresponding discussion on how the trustperformed in the national patient surveyoccupied one paragraph.

Although board members assured us that thecare of patients was their top priority, this wasnot apparent from the minutes, or from thedecisions they took. The minutes and papersfor the governance committee were only takento the private meetings but, even there, therewas no record of them being discussed andlittle generally about the quality of care. Thesecretary to the board stated that the minutesdid not reflect the balance of what wasdiscussed, since decisions and action werenoted rather than debate. We noted, however,that this did not appear to apply to finance andthat few actions were noted in respect of thequality of care.

The trust’s response to the financialimperatives that faced the NHS in 2006/07 wasmisjudged. The trust agreed to make savingsof £10 million to improve its financial position.This equated to about 8% of turnover. Of this,£1 million was to create a surplus, which thetrust has said it had to use to repay brokerageto the PCT.

In making the decision to save £10 million, thetrust did not conduct a rigorous assessment ofthe effects on services to patients of losing atleast 150 posts. It did not consider in whichareas the trust could not afford to lose staff.While the stated aim was to minimise thenumber of clinical staff that would be affected,managers did not control the redundancyprogramme and there was a failure torecognise the negative effect that this washaving on morale and so lost more key staffthan intended.

When the trust declared a surplus of £1 millionat the end of 2006/07, it did not reinvest in staff,but has said it had to repay brokerage to thePCT. In July 2007, the board agreed a further £8million cost improvement programme over thenext two years, to meet national requirementsand improve the surplus. These decisions weredivorced from the reality of care for patients inA&E or on the wards where emergency patientswere treated. The trust board was aware at thistime that a high proportion of their own staffwould have no confidence as a patient in thecare at the trust.

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What actions has the trust taken sincethe start of the investigation?It is, of course, impossible to determine whatactions would have been taken if there had notbeen an investigation. The agreement at theend of March 2008 to fund the deficit innursing numbers was taken after the boardknew there was going to be an investigation.

Since January 2008, there has been a net gainof 46 qualified nurses and 51 healthcaresupport workers. The trust has increased thenumber of matrons from three to 12. However,in November 2008, the trust’s board noted thatthe trust was 40 nurses below the previouslyagreed establishment. The minutes of themeeting also record that no further funding orrecruitment was planned because of thedifficult financial position for 2008/09. Thetrust, though, has told us that the board hasnot stopped recruitment and will, as part ofthe 2009/10 business plan, revisit theestablishment review and take a view ofrecruiting to the outstanding posts.

When we have expressed concerns to thetrust, it has welcomed our comments,responded positively and begun to take action.The trust received formal notification of ourconcerns about the A&E department on 23May 2008. It immediately set up a steeringgroup for emergency care, led by an externalindividual who was previously the national leadfor emergency care at the Department ofHealth.

Considerable progress has been made in A&E,but there is a need to maintain and build onthe improvement. Two new consultants wereappointed in November, but the original onewent on long-term sick leave. The middlegrade rota was fully staffed and there was aprogramme of training for junior and middlegrade doctors. The number of nursesincreased, but many of the new staff werequite inexperienced and there is still only oneband seven nurse for clinical practice. A newmodel of care was introduced in the autumn of2008. A triage system was put into place for 12hours a day.

Ward-based training on the use of themodified early warning score (MEWS) wasintroduced in the autumn of 2008. A trainingpackage was agreed to ensure competency forthe use of cardiac monitors. A four-beddedsurgical assessment unit was opened. Twoadditional beds were opened on the traumaward. The trust is reviewing the provision ofemergency theatre lists at weekends.Additional sessions have been arranged atshort notice when necessary.

The mortality group has become the clinicaloutcomes group and is now chaired by thechief executive. The trust reports that it istaking action to ensure that change happensfollowing complaints. Early signs are thatmortality for emergency admissions is lowerthan previously.

Summary of conclusionsDespite a system that looked good on paper,the trust did not have a clinical governancestructure or audit process that worked. It hadno effective system for monitoring outcomesfor patients and so failed to identify orunderstand the cause of high death ratesamong patients admitted as emergencies.This was a serious failing. When the highmortality rates were drawn to the attention ofthe trust, it looked primarily to problems withdata as an explanation, rather than poor care.The trust’s board and senior leaders did notinform themselves sufficiently about thequality of care.

The clinical management of many patientsadmitted as emergencies fell short of anacceptable standard in at least one aspect ofbasic care. Some patients, who might havebeen expected to make a full recovery fromtheir condition at the time of admission, didnot have their condition adequately diagnosedor treated. Often, these shortcomings were notrecognised and lessons were not learned.

The trust stabilised its finances andsuccessfully focused on becoming afoundation trust. However, it lost sight of whatshould have been its main priority: to provide

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high quality care to all of its patients. It took adecision to significantly reduce staff withoutproperly assessing the consequences. Itsstrategic focus was on financial and businessmatters at a time when the quality of care ofits patients admitted as emergencies was wellbelow acceptable standards.

The trust deserves credit for respondingpositively to the concerns raised by theCommission and taking action.

The role of external organisationsSouth Staffordshire Primary Care Trust (PCT)received little information from thepredecessor primary care trusts regardingservices provided by the trust. Neither thecommissioning process nor other sources ofinformation indicated concerns about thequality of care at the trust. The PCT told us itwas also reassured by the trust’s ratings inthe annual health check and its application tobecome a foundation trust.

The PCT became aware of concerns at thesame time as the Healthcare Commissionraised concerns, in early 2008. It responded tothe ‘Cure the NHS’ group by acting as anadvocate to help resolve the concerns ofindividuals. It also contacted its two localcommissioning groups to check the views ofGPs on the quality of care. The responseswere highly critical of the trust. The PCT thenundertook an unannounced visit to the trust inApril 2008 and identified a number ofconcerns. It ensured that action was taken bythe trust to address staffing shortages and thelack of clinical leadership.

The PCT agreed to provide some additionalfunding to the trust to support a number ofshort-term initiatives to improve quality,including employing additional senior nursingstaff in A&E. The PCT also suggested that thetrust used the internal reserves it hadgenerated through its planned surplus.Additionally, it set up a GP service in A&E tohelp manage patients who needed primarycare rather than an emergency service.

The West Midlands Strategic Health Authority

(SHA) also suffered from an inadequatehandover of information from its predecessorbodies regarding the performance of the trust.It was not aware of any concerns regardingthe quality of services provided by the trustuntil the publication by Dr Foster of itsHospital Guide in April 2007. This showed thetrust to have a hospital standardised mortalityratio of 127 for 2005/06. Other trusts in theWest Midlands also had high rates. The SHAaccepted without detailed scrutiny the trust’saccount of its actions in relation to mortality.Again, it told us it was reassured by the trust’sratings in the annual health check and itsapplication to become a foundation trust.

The SHA also commissioned the University ofBirmingham to undertake research into themortality rates published in the Hospital Guidein April 2007.

We considered that information from thecoroner would be useful for this investigation,and we were disappointed that he declined toprovide us with any.

The national picture and lessons forother organisationsA number of the findings of this investigationin respect of acute hospital care arepotentially relevant to the whole NHS. Theseinclude the need for:

• Trusts to be able to access timely andreliable information on mortality and otheroutcomes, and for trusts to conductobjective and robust reviews of mortalityrates and individual cases, rather thanassuming data errors.

• Trusts to recognise if the quality of careprovided to patients admitted asemergencies falls below acceptablestandards and to ensure that a focus onelective work and targets is not to thedetriment of emergency admissions. Caremust be provided to an acceptable standard24 hours a day, seven days a week.

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• Trusts to ensure that a preoccupation withfinances and strategic objectives does notcause insufficient focus on the quality ofpatient care.

• Trusts to ensure that systems forgovernance that appear to be persuasive onpaper actually work in practice, andinformation presented to boards onperformance (including complaints andincidents) is not so summarised that it failsto convey the experience of patients orenable non-executives to scrutinise andchallenge on issues relating to patient care.

• Senior clinical staff to be personallyinvolved in the management of vulnerablepatients and in the training of juniormembers of staff, who manage so much ofthe hour-by-hour care of patients.

• Trusts to identify and resolve shortcomingsin the quality of nursing care relating tohygiene, provision of medication, nutritionand hydration, use of equipment, andcompassion, empathy and communication.

• Good handovers when reorganisations andmergers occur in the NHS.

• PCTs to ensure that they have effectivemechanisms to find out about theexperience of patients and the quality ofcare in services they commission.

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137Investigation into Mid Staffordshire NHS Foundation Trust

In this report, we have drawn together thedifferent strands of numerous, wide-rangingand serious findings about the trust which,when brought together, we consider amount tosignificant failings in the provision ofemergency healthcare and in the leadershipand management of the trust.

We have therefore written to Monitor, theregulator of NHS foundation trusts, inaccordance with the Health and Social Care(Community Health and Standards) Act 2003(s53(6)), to highlight these significant failings.We had previously raised concerns withMonitor about the leadership of the trust, andwe note that both the chairman and chiefexecutive have left the trust in the two weeksleading up to the publication of this report.

Irrespective of the above, we expect the trustto consider all aspects of this report, includingall our findings, which detail serious failings atdifferent levels and across different parts ofthe trust’s services. Here, we highlight whereaction is particularly important.

Action by the boardThe trust’s board must ensure that there is asystematic means of monitoring rates ofmortality and other outcomes for patients.This information should inform the board’sdiscussions about the quality of services at thetrust, and also inform action taken to improveoutcomes for patients.

More generally, the trust’s board needs toreflect on its arrangements for overseeing thequality and safety of clinical care within thetrust. In particular, how the trust:

• Develops and promotes an open, learningculture.

Recommendations

• Collects and reports informationaccurately, both internally and externally,and in sufficient detail.

• Identifies and mitigates risks to the safetyof its patients.

• Identifies correctly, and then reports,investigates adequately and learns fromserious incidents and unexpected deaths.

• Learns from, and ensures that necessaryimprovements are made followingincidents, near misses and complaints.

• Engages clinicians and develops effectiveclinical audit.

• Considers and acts on the views andexperiences of patients who use the trust’sservices.

A&E departmentRecent improvements to the emergencydepartment must be sustained and extendedto ensure that the service is safe, that it meetsthe needs of patients, and that the departmentis adequately staffed and equipped at all times.

Staffing and capacityThe trust must continue the work it hasstarted to recruit additional nursing andmedical staff, to ensure that care provided topatients throughout the trust, including atnight and at weekends, is safe and keeps toaccepted standards.

The trust needs to review the training andsupervision of its nursing staff and juniordoctors, to ensure that they are undertakingappropriate roles, are confident and clearabout the expectations placed on them, andare receiving all necessary support.

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The trust must ensure adequate availability oftheatre sessions to ensure that it is able tohandle demand in an emergency withoutdelay, and has an effective means ofdetermining which cases requiring emergencysurgery should receive priority.

The trust must ensure that there is adequateaccess for clinical staff to advice and supportfrom medical staff in the critical care(intensive care) service, and ensure this isindependent of the availability of beds in thecritical care unit.

Standards of careThe trust must ensure that its medical andnursing staff deliver basic aspects of care,such as reviewing patients on a regular basis,monitoring their condition, and identifying andmanaging any complications that may arise.The trust must ensure that there is timelyreview of patients by senior doctors.

In the light of specific findings in this report,the trust needs to audit its arrangements forand, where appropriate, equipment used inrelation to: medication (particularly onadmission and for patients who are ‘nil bymouth’); the resuscitation of patients; non-invasive ventilation; cardiac monitoring; andanticoagulation.

National recommendationsAnalysis undertaken in this and other trusts*shows worrying variations across the NHS inthe quality of coding of clinical outcomes, andvariations in the extent to which statisticalinformation is used to monitor the quality oflocal services and inform decisions at a seniorlevel within NHS trusts.

This is of concern in a modern, information-driven health service where the interpretationand use of data is a fundamental means ofimproving clinical care. We recommendformally that all NHS trust boards have accessto comparative data on outcomes for patients,

including mortality, that is accurate, completeand as up-to-date as possible.

While recognising the challenges in ensuringthat mortality rates are accurate andexpressed in a way that does not causeunnecessary alarm among patients, or lead tounhelpfully risk-averse behaviour amongclinicians, we believe that mortality rates canbe published in a meaningful way to helppatients to make informed choices about thequality of clinical care.

Boards of NHS trusts need to be focused at alltimes on the safety and quality of the servicesprovided to patients. This includes havinginformation available to boards that properlycaptures the experience of patients, so thatnon-executives can scrutinise and challengethe care received by patients.

The NHS and appropriate professional andeducational bodies need to examine why theexperience of patients on general wards intrusts that we have investigated continues tobe of a poor standard, and take urgent actionto improve the quality of nursing care in theseareas.

PCTs need to develop more effectivemechanisms to learn about the quality of care,the actual experience of patients and theoutcomes of care in services that theycommission, and give more priority to thisaspect of commissioning.

The NHS needs to ensure effective handoverswhen reorganisations and mergers occur, sothat information on services is transferredeffectively to the new organisation.

Investigation into Mid Staffordshire NHS Foundation Trust138

* Healthcare Commission, Following up mortality 'outliers': A review of the programme for taking action where data suggest theremay be serious concerns about the safety of patients, February 2009

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The Healthcare Commission works to improvethe quality of healthcare provided by the NHSand the independent (private and voluntary)sector. One of its functions is to investigateserious failures in NHS services.

What will the Healthcare Commissioninvestigate? The Healthcare Commission will investigateallegations of serious failings that have anegative impact on the safety of patients,clinical effectiveness or responsiveness topatients. This may include:

• A higher number than anticipated, orunexplained, deaths, serious injury orpermanent harm, whether physical,psychological or emotional.

• Events that put at risk public confidence inthe healthcare provided, or in the NHSmore generally.

• A pattern of adverse effects or otherevidence of high risk activity.

• A pattern of failures in service(s) or team(s)or concerns about these.

• Allegations of abuse, neglect ordiscrimination against patients.

Other failings with less serious effects onpatients’ safety may be subject to a review. Indetermining whether to investigate, theHealthcare Commission will consider theextent to which local resolution, referral to analternative body, or other action might offer amore effective solution.

The Healthcare Commission does notinvestigate:

• A complaint that has not been pursuedthrough the NHS complaints procedure orthe Healthcare Commission’s independentstage, unless it raises an immediateconcern.

• Individual complaints about professionalmisconduct.

• Changes to service configurations.

• Matters being considered by legal process.

• Specific matters already determined bylegal process.

This does not preclude the HealthcareCommission from investigating circumstancessurrounding such matters, particularly if thereare general concerns about patient safety orsuggestions that organisational systems areflawed.

139Investigation into Mid Staffordshire NHS Foundation Trust

Appendix A: The Healthcare Commission’scriteria for an NHS investigation

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Dr Heather WoodInvestigation ManagerHealthcare Commission

Paul FontaineInvestigation CoordinatorHealthcare Commission

David HarveyTeam Leader, Investigations Analyst TeamHealthcare Commission

George CatfordInvestigations AnalystHealthcare Commission

Amy HillsSenior AnalystHealthcare Commission

Birgit HollandInvestigations AnalystHealthcare Commission

James MountainInvestigations AnalystHealthcare Commission

Chris Sherlaw-JohnsonSurveillance Team LeaderHealthcare Commission

Mr Tony GiddingsFormer Consultant Surgeon King’s College and Guy’s & St Thomas’ NHS TrustSurgical adviser to the National ClinicalAdvisory Team of the NHS

Mr Graham JohnsonConsultant in Emergency Medicine andDivisional Medical Manager for MedicineDivisionLeeds Teaching Hospitals NHS Trust

Lindsey ScottChief Nurse and Director of GovernanceUniversity Hospitals Bristol NHS FoundationTrust

Mark TaylorFormer Chief Executive Royal Brompton and Harefield NHS TrustVice Chairman of the National Institute forHealth and Clinical Excellence

Dr Simon WalfordConsultant Physician Former Medical DirectorRoyal Wolverhampton Hospitals NHS Trust

Investigation into Mid Staffordshire NHS Foundation Trust140

Appendix B: The investigation team

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The investigation team conducted a total of309 interviews. Of these, 205 involved 197former or current trust staff (some peoplewere interviewed more than once). Table 1contains more details regarding the formerand current staff interviewed.

The investigation team were in contact with139 stakeholders (that is, members of the

public or members of external organisationsassociated with the trust). Of these, 125stakeholders were interviewed in more than100 interviews. Stakeholders were interviewedface-to-face or by telephone, either as a resultof contacting the investigation team or inresponse to an invitation from the team.Tables 2 and 3 provide more details regardingthe stakeholders involved in this investigation.

141Investigation into Mid Staffordshire NHS Foundation Trust

Appendix C: Interviews

Table 1: Trust staff and former trust staff interviewed

Chief executive and executives 10Chairman, non-executive directors and governors 10Senior nurses and specialist nurses 19Ward nurses and healthcare assistants 41Consultants (including clinical directors and heads of division) 33Junior and middle grade doctors 28Senior and middle managers 29Pharmacy staff, allied health professionals and chaplain 10Administrative and legal staff, and analysts 9Domestic and portering staff 5Union representatives (trust staff) 3Total 197

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Table 2: Stakeholders interviewed

Patients, carers and relatives and members of the patient and public involvement forum 96West Midlands Strategic Health Authority and the former Shropshire and Staffordshire Strategic Health Authority 7Postgraduate medical dean for the West Midlands Deanery 1South Staffordshire Primary Care Trust 6University Hospital of North Staffordshire NHS Trust 3West Midlands Ambulance Service NHS Trust 2Coroner for the Staffordshire (south) district 1Union representative (non-trust staff) 1Local government 5Members of Parliament 1Auditors 2Total 125

Table 3: Other stakeholders who contacted us

Patients and relatives 7Members of Parliament 4Others 3Total 14

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143Investigation into Mid Staffordshire NHS Foundation Trust

Appendix D: Sources of information

• Interviews and correspondence withpatients, relatives, carers and members ofthe patient and public involvement forum.

• Interviews and correspondence with pastand present trust staff.

• Observations on the wards.

• Case notes and the trust’s reviews of thecase notes of a sample of patients who haddied at the trust.

• Interviews with staff from SouthStaffordshire Primary Care Trust (PCT),West Midlands Strategic Health Authority(SHA) and other organisations in the localhealth community.

• Interviews and correspondence withMembers of Parliament.

• Interviews with local councillors, includingmembers of the overview and scrutinycommittee.

• Minutes of trust meetings, includingmeetings of the trust’s board, clinicalgovernance, clinical audit group, audit andremuneration and terms of servicecommittees, risk management committees,the trust’s hospital management boards,the senior nurses’ meetings, directorateand departmental meetings including theinfection control team and committee andoutbreak meetings.

• Reports to the trust’s board, auditcommittee and other trust committees.

• Relevant trust policies and proceduresincluding operational policies for A&E andthe emergency assessment unit (EAU), andstaffing shift patterns for A&E and the EAU.

• Reports on emergency care incidents andcomplaints.

• Nursing skill mix review 2007/08.

• The trust’s training policies, and plans anddetails of training completed by differentgroups of staff.

• The trust’s data on deaths followingemergency admissions.

• Ombudsman reports supplied by the trust.

• Such annual reports on infectionprevention and control from 2005 as wereavailable.

• Infection control outbreak reports.

• List of outbreaks of healthcare-associatedinfections reported to the HealthProtection Agency and the SHA since 2005,and data on numbers of new cases ofhospital-acquired MRSA and C. difficile bymonth.

• Information from the trust on incidents inthe medical and surgical divisions(including reports of serious untowardincidents).

• Details of relevant complaints regardingthe medical and surgical divisions.

• Clinical audit summary reports.

• The trust’s audit on inpatient drugprescriptions in the EAU in 2008.

• ‘Snapshots’ of the trust’s risk registers andthe trust assurance framework.

• Information on relevant complaints.

• Clinical governance documentation, suchas the risk register and assuranceframework.

• Self-assessments, audits and positionstatements by the trust.

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• Ward assurance frameworks, and reportsand briefing details on these.

• Analysis of trust data on death certificatesand mortality figures.

• The trust's submission to the HealthcareCommission's urgent care review.

• The trust's website.

• Information from West Midlands SHA,South Staffordshire PCT and otherorganisations in the local healthcarecommunity.

• Information from the Audit Commission,Postgraduate Medical Education andTraining Board and other statutorystakeholders.

• Information from the National ConfidentialEnquiry into Patient Outcome and Death(NCEPOD).

• Analysis by the acute hospital portfolioteam at the Healthcare Commission.

• Findings from the Healthcare Commission’snational surveys of adult inpatients andstaff in the NHS.

• Details of NHS second stage complaintsreceived by the Healthcare Commissionfrom 2005 to 2008.

• Reports commissioned by the trust,including the clinical review by the RoyalCollege of Surgeons of colorectal services.

• Survey by Ipsos MORI commissioned by thetrust in May 2008.

• Mortality data supplied by the Dr FosterResearch Unit at Imperial College ofScience, Technology and Medicine.

• Report of the Department of Health’sCleaner Hospitals Team visit in October2007.

• Report of South Staffordshire PCT’s visit tothe trust in April 2008.

• Royal College of Physicians’ NationalSentinel Stroke Audit for 2006.

• Guidance from the National Institute forHealth and Clinical Excellence, NCEPOD,the Royal College of Physicians and theSociety of Acute Medicine.

• Summaries by the trust of some inquestsinvolving the trust and their findings.

• Clinical Negligence Scheme for Trusts’report, April 2008.

• Hospital Episode Statistics.

• Mortality data provided by the Office forNational Statistics.

• Department of Health statistics and trustdata on surgical volume.

• National sickness absence level provided bythe Information Centre for Health andSocial Care.

Where appropriate, we also took account ofthe absence of relevant information and thetrust’s inability to provide us with informationor evidence in particular areas.

Investigation into Mid Staffordshire NHS Foundation Trust144

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Concerns about outcomes at the trust:outlier alertsTable 4 details the mortality alerts generatedin relation to the trust. It shows the source ofthe alert, when it was generated and thepatient groups that they relate to.

Dr Foster Intelligence real-timemonitoring system The real-time monitoring system produced byDr Foster Intelligence uses standardisedmethodologies (designed by Professor SirBrian Jarman and Dr Paul Aylin) to allowtrusts to compare their clinical outcomesagainst all other acute trusts in England, andagainst a local peer group. The system is alsoable to monitor outcomes for specificconsultant teams, and by specialty. Where asignificant divergence in a clinical outcome isdetected, an automated alert is produced. DrFoster states that 70% of acute trusts havepurchased their real-time monitoring system.

The Healthcare Commission was provided withoutput from the trust’s real-time monitoringsystem for non-elective admissions for2007/08. Table 5 shows where the trustsignalled with significantly high mortality(shown in normal text) and significantly lowerthan expected mortality (shown in italic text).The output below shows the number of spells(that is, stay in hospital: a period commencingwith admission to hospital and ending ondischarge) over the year in each patient groupand the number of deaths within that groupcompared to the number that would beexpected given the risk adjustment used in DrFoster’s model.*

145Investigation into Mid Staffordshire NHS Foundation Trust

Appendix E: Statistical appendix

Standardised in-hospital mortality

Outcomes for patients admitted asemergencies

Table 6 shows that standardised mortalityratios at the trust have been significantlyhigh, at the 5% level (p 0.05), for the 18+age group, over the three financial yearscovered by this investigation. SMRs are alsosignificantly high for the separate subgroupsof patients aged 18 to 74 and 75+. SMRs forthe 18+ age group are also illustrated in afunnel plot (figure 5). The horizontal axisrepresents the number of expected deaths atthe trust in each year. This is higher in 2007/8in comparison to the previous two yearsmainly because more patients are beingassigned higher risk HRGs. This could reflectmore complete coding.

Outcomes for patients admitted electively

Equivalent standardised mortality analysiswas carried out to examine mortalityoutcomes for elective admissions at MidStaffordshire. This analysis did not indicateany concerns about higher than expectedmortality (See table 7).

Figure 6 shows that the trust’s SMRs forelective admissions aged 18+ have beenconsistently within expected limits.

v

* Bottle A, Aylin P, “Intelligent Information: A National System for Monitoring Clinical Performance”, Health Services Research2008; 43:10-31

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Table 5: Output from the trust’s real-time monitoring system for non-elective admissionsfor 2007/08

Diagnosis group (discharge) Spells % Deaths % Expected % Relative riskAll 8826 100% 934 10.6% 807.4 9.2% 115.7Abdominal pain 976 11.1% 0 0% 3.8 0.4% 0Cardiac dysrhythmias 404 4.5% 1 0.3% 7.7 1.9% 13Acute cerebrovascular disease 353 4% 129 36.8% 95.2 27.1% 135.5Urinary tract infections 340 3.9% 6 1.8% 18.2 5.4% 32.9Noninfectious gastroenteritis 315 3.6% 2 0.6% 7.4 2.4% 26.9Other lower respiratory disease 120 1.4% 17 14.2% 9.6 8% 177.6Cancer of bronchus lung 82 0.9% 36 43.9% 23.9 29.1% 150.6Septicemia (except in labour) 72 0.8% 46 63.9% 26.8 37.3% 171.4Cancer of ovary 20 0.2% 8 40% 2.9 14.5% 276.6Intestinal infection 11 0.1% 5 45.5% 1.6 14.3% 317.5Cancer of rectum and anus 10 0.1% 6 60% 1.9 19.1% 313.8Other infections including parasitic 3 0% 2 66.7% 0.2 6.2% 1067.2Peri- endo- and myocarditis cardiomyopathy 2 0% 2 100% 0.2 8.5% 1172.7Sickle cell anaemia 1 0% 1 100% 0 1.1% 9147.7

Table 4: Patient groups identified as mortality outliers for Mid Staffordshire NHSFoundation Trust

Patient group Generated by Date generatedAlerts generated prior to the launch of the investigation Operations on jejunum Dr Foster July 2007Aortic, peripheral and visceral artery aneurysms Dr Foster August 2007Diabetes Healthcare Commission August 2007Peritonitis and intestinal abscess Dr Foster August 2007Epilepsy and convulsions Healthcare Commission September 2007Repair of abdominal aortic aneurysm Healthcare Commission October 2007Other circulatory disease Dr Foster November 2007Alerts generated after the launch of the investigationChronic renal failure Dr Foster July 2008Non-transient stroke Healthcare Commission October 2008Other non-viral infections Healthcare Commission October 2008Pulmonary heart disease Dr Foster November 2008

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147Investigation into Mid Staffordshire NHS Foundation Trust

Table 6: Cross-sectional standardised in-hospital mortality outcomes for Mid StaffordshireNHS Foundation Trust (emergency admissions)

Financial year 18 to 74 75+ All aged 18+2005/06 SMR = 148 SMR = 144 SMR = 145

p = 0.001 p = 0.001 p = 0.0012006/07 SMR = 147 SMR = 134 SMR = 137

p = 0.001 p = 0.001 p = 0.0012007/08 SMR = 136 SMR = 124 SMR = 127

p = 0.01 p = 0.01 p = 0.003

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2007/08

Upper control limit (1%)

Lower control limit (1%)

Figure 5: Cross-sectional standardised in-hospital mortality outcomes for Mid StaffordshireNHS Foundation Trust (emergency admissions aged 18+) by year

Source: Hospital Episode Statistics

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Investigation into Mid Staffordshire NHS Foundation Trust148

Table 7: Cross-sectional standardised in-hospital mortality outcomes for Mid StaffordshireNHS Foundation Trust (elective admissions)

Financial year 18 to 74 75+ All aged 18+2005/06 SMR = 118 SMR = 74 SMR = 96

p = 0.29 p = 0.83 p = 0.562006/07 SMR = 73 SMR = 97 SMR = 85

p = 0.81 p = 0.54 p = 0.732007/08 SMR = 97 SMR = 118 SMR = 107

p = 0.53 p = 0.29 p = 0.39

Source: Hospital Episode Statistics

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Figure 6: Cross-sectional standardised in-hospital mortality outcomes for Mid StaffordshireNHS Foundation Trust (elective admissions aged 18+) by year

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149Investigation into Mid Staffordshire NHS Foundation Trust

Non-standardised in-hospital mortalityrates for emergency admissionsTable 8 shows the crude mortality rate at thetrust within each age group by financial year,and a p value indicating how significant thedifference is when the trust’s rate is comparedto other non-specialist acute trusts.

Figures 7 and 8 show the trust’s crudequarterly mortality rates for emergencyadmissions, compared with the mortality ratesfor all non-specialist acute trusts in Englandand for a peer group of nine other trusts (seenext section) identified by Casp HealthcareKnowledge Systems (CHKS, a UK provider ofcomparative information and qualityimprovement services for healthcareprofessionals).

Over the three years covered by theinvestigation (from 2005/2006 onwards), thetrust’s rates have been consistently higherthan both the national and peer group oftrusts each quarter, both for admissions aged18 to 74 and those aged 75 and over (with theexception of the 75 and over age range in thesecond quarter of 2005/06). During 2003/04and 2004/05, a similar pattern was seen forthe 18 to 74 age group, while the rates for the75+ age group were more variable and onoccasion were lower than the peer groupmortality rate. See table 9 for the numbers of

Table 8: Cross-sectional non-standardised in-hospital mortality outcomes for Mid StaffordshireNHS Foundation Trust (emergency admissions)

Financial year 18 to 74 75+ All aged 18+2005/06 Rate = 3.3% Rate =16.2% Rate =7.8%

p = 0.02 p = 0.01 p = 0.02National rate = 2.5% National rate = 12.7% National rate = 5.7%

2006/07 Rate =3.5% Rate =16.2% Rate =8.0%p = 0.003 p = 0.004 p = 0.005National rate = 2.3% National rate = 12.3% National rate = 5.5%

2007/08 Rate =3.5% Rate =16.0% Rate =8.1%p = 0.001 p = 0.002 p = 0.002National rate = 2.3% National rate = 11.9% National rate = 5.3%

Source: Hospital Episode StatisticsNational rate is for all non-specialist acute trusts in England

admissions and deaths at the trust uponwhich this analysis is based.

Peer group comparisonThe peer group suggested to the HealthcareCommission by the trust was established byCHKS, by matching trusts of similar size,demographics of surrounding population andclinical activity. The trusts included in MidStaffordshire’s peer group are:

• Airedale NHS Trust

• Barnsley District General Hospital NHSFoundation Trust

• Burton Hospitals NHS Trust

• Dudley Group of Hospitals NHS Trust

• East Cheshire NHS Trust

• Southport and Ormskirk Hospitals NHSTrust

• The Countess of Chester Hospital NHSFoundation Trust

• The Rotherham NHS Foundation Trust

• Wrightington, Wigan and Leigh NHS Trust.

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5.0%

4.5%

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0.0%03/04 03/04 03/04 03/04 04/05 04/05 04/05 04/05 05/06 05/06 05/06 05/06 06/07 06/07 06/07 06/07 07/08 07/08 07/08 07/08

Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4

Financial year and quarter

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Peer group mean

Figure 7: Non-standardised in-hospital mortality rates among emergency admissionsaged 18 to 74 (April 2003 to March 2008)

Source: Hospital Episode StatisticsNote: The vertical line represents the start of the period covered by the investigation

20%

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0%03/04 03/04 03/04 03/04 04/05 04/05 04/05 04/05 05/06 05/06 05/06 05/06 06/07 06/07 06/07 06/07 07/08 07/08 07/08 07/08

Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4

Financial year and quarter

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National mean (excluding specialists)

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Figure 8: Non-standardised in-hospital mortality rates among emergency admissionsaged 75+ (April 2003 to March 2008)

Source: Hospital Episode StatisticsNote: The vertical line represents the start of the period covered by the investigation

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151Investigation into Mid Staffordshire NHS Foundation Trust

HES-submitted emergency activity atMid Staffordshire NHS FoundationTrust Table 9 shows, for each quarter from 2003/04to 2007/08 by age group, the numbers ofpatients that were discharged from the trust,the numbers of patients that died and theassociated mortality rate.

Standardised HRG chapter level in-hospital mortality for emergencyadmissions

Cross-sectional standardised in-hospitalmortality outcomes by HRG chapter and agegroup (emergency admissions)

Chapters and age groups that havesignificantly high mortality (at the 5% level, p 0.05) are shown as shaded in table 10. HRG chapters with persistently high mortalityover both 2006/07 and 2007/08 were:

• Cardiac surgery and primary cardiacconditions (ages 18-74)

• Vascular system (ages 18-74)

• Nervous system (ages 75+)

• Respiratory system (ages 75+)

• Haematology, infectious diseases,poisoning and non-specific groupings (ages18-74 and 75+).

Additionally, chapters that becamesignificantly high in 2007/2008 were:

• Nervous system (ages 18-74).

• Musculoskeletal system (ages 75+).

v

Standardised HRG chapter level ONS-linked total 30-day mortality Outcomes are categorised into whether theyare higher, lower or similar to expectedcompared with other acute trusts in England,when standardised by sex, age, admissionmethod and HRG. In particular, the HRGchapters relating to ‘nervous system’,‘respiratory system’, ‘cardiac surgery andprimary cardiac conditions’, ‘digestive system’,‘spinal surgery and primary spinal conditions’and ‘haematology, infectious diseases,poisoning and other non specific groupings’were all categorised as having much higherthan expected outcomes. Additionally, chapters‘mouth, head, neck and ears’, ‘vascularsystem’, and ‘mental health’ were categorisedas higher than expected. The ‘obstetrics andneonatal care’ chapter was the only chaptercategorised as having lower than expectedoutcomes. See table 11 for information onoutcomes for all HRG chapters.

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Table 9: Numbers of discharges and deaths after emergency admission at Mid StaffordshireNHS Foundation Trust (2003/4 Q1 to 2007/8 Q4)

18 to 74 75+Quarter Discharges Deaths Mortality Discharges Deaths Mortality

rate rate2003/4 Q1 1984 63 3.18% 988 165 16.70%2003/4 Q2 2044 70 3.42% 999 151 15.12%2003/4 Q3 2098 90 4.29% 1073 191 17.80%2003/4 Q4 2056 78 3.79% 1123 172 15.32%2004/5 Q1 2309 83 3.59% 1124 149 13.26%2004/5 Q2 2128 61 2.87% 1127 156 13.84%2004/5 Q3 2357 80 3.39% 1194 170 14.24%2004/5 Q4 2394 99 4.14% 1298 226 17.41%2005/6 Q1 2243 67 2.99% 1180 194 16.44%2005/6 Q2 2342 60 2.56% 1220 151 12.38%2005/6 Q3 2333 82 3.51% 1186 202 17.03%2005/6 Q4 2098 88 4.19% 1229 234 19.04%2006/7 Q1 2185 79 3.62% 1140 189 16.58%2006/7 Q2 2122 78 3.68% 1038 162 15.61%2006/7 Q3 2109 56 2.66% 1227 196 15.97%2006/7 Q4 1966 80 4.07% 1167 193 16.54%2007/8 Q1 2108 77 3.65% 1281 178 13.90%2007/8 Q2 2143 80 3.73% 1153 173 15.00%2007/8 Q3 2112 59 2.79% 1300 219 16.85%2007/8 Q4 2157 79 3.66% 1257 228 18.14%

Source: Hospital Episode StatisticsHES submitted activity from 2005/06 Q1 onwards agreed by the trust

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HRG 2006/07 2007/08Chapter Description 18 - 74 75+ 18 - 74 75+A Nervous System SMR = 135 SMR = 143 SMR =173 SMR = 145

P = 0.075 P = 0.003 P = 0.002 P = 0.001B Eyes and periorbita SMR = 0 SMR = 0 SMR = 0 SMR = 0

P = 0.728 P = 0.794 P = 0.687 P = 0.708C Mouth, Head, Neck and Ears SMR = 51 SMR = 153 SMR = 0 SMR = 170

P = 0.790 P = 0.221 P = 0.991 P = 0.176D Respiratory System SMR =125 SMR =121 SMR = 115 SMR =121

P = 0.067 P = 0.045 P = 0.156 P =0.029 E Cardiac Surgery and SMR =159 SMR =144 SMR =144 SMR =118

Primary Cardiac Conditions P = 0.005 P =0.004 P = 0.029 P = 0.123F Digestive System SMR =155 SMR =126 SMR =131 SMR =95

P = 0.004 P = 0.054 P = 0.088 P = 0.638G Hepato-Biliary and SMR =139 SMR =111 SMR =107 SMR =115

Pancreatic System P = 0.120 P = 0.347 P = 0.412 P = 0.276H Musculoskeletal System SMR =224 SMR =112 SMR =167 SMR =151

P = 0.004 P = 0.294 P = 0.078 P = 0.020J Skin, Breast and Burns SMR =133 SMR =82 SMR =77 SMR =72

P = 0.221 P = 0.677 P = 0.724 P = 0.823K Endocrine and Metabolic SMR =250 SMR =130 SMR =81 SMR =85

System P = 0.019 P = 0.207 P = 0.647 P = 0.657 L Urinary Tract and Male SMR =138 SMR =156 SMR =129 SMR =105

Reproductive System P = 0.161 P =0.008 P = 0.198 P = 0.400M Female Reproductive System SMR = 0 SMR = 346 SMR =240 SMR =81

P = 0.979 P = 0.096 P = 0.109 P = 0.590 N Obstetrics and Neonatal SMR =0 Not SMR =0 Not

Care P = 0.560 Applicable P = 0.564 ApplicableQ Vascular System SMR =251 SMR =130 SMR =296 SMR =113

P = 0.004 P = 0.189 P = 0.001 P = 0.329R Spinal Surgery and Primary SMR =146 SMR =202 SMR =0 SMR =69

Spinal Conditions P = 0.317 P = 0.093 P = 0.970 P = 0.714S Haematology, Infectious SMR =151 SMR =160 SMR =193 SMR =165

Diseases, Poisoning and P = 0.034 P = 0.005 P = 0.002 P = 0.001 Non-Specific Groupings

T Mental Health SMR =0 SMR =165 SMR =0 SMR =156P = 0.843 P = 0.232 P = 0.934 P = 0.184

153Investigation into Mid Staffordshire NHS Foundation Trust

Table 10: Cross-sectional standardised in-hospital mortality outcomes by HRG chapter andage group

Source: Hospital Episode Statistics

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Table 11: Total 30-day mortality by HRG chapter at Mid Staffordshire NHS FoundationTrust (April 2006 to December 2006)

Much worse than Worse than Similar to Tending towards Better thanexpected expected expected better than expected

expected Chapter A Chapter C – Chapter G – Chapter B – Chapter N – Nervous system Mouth, head, neck Hepato-biliary & Eyes and Obstetrics and

and ears pancreatic system periorbita neonatal careChapter D – Chapter Q – Chapter H –Respiratory Vascular system Musculoskeletal system systemChapter E – Chapter T – Chapter J –Cardiac surgery mental health Skin, breast andand primary burnscardiac conditionsChapter F – Chapter K –Digestive system Endocrine and

metabolic systemChapter R – Chapter L –Spinal surgery Urinary tract andand primary male reproductivespinal conditions systemChapter S – Chapter M – Haematology, Female infectious reproductivediseases, systempoisoning and non- specific groupings

Chapter P – Diseases of childhoodChapter U – Undefined groups

Source: Hospital Episode Statistics linked ONS Mortality dataAnalysis is based on all ages and all admission methods

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Discharges and deaths at MidStaffordshire NHS Foundation Trust, by specialtyTable 12 outlines the specialty to whichdischarges and deaths were coded for theiradmission episode at the trust. The specialtycoded is based on the contracted specialty ofthe consultant, rather than the specialty underwhich they were working at the time.

Source: Hospital Episode StatisticsNumbers between 1 and 5, and their associated proportions, have been suppressed and replaced with ‘*’.

Table 12: Discharges and deaths at Mid Staffordshire NHS Foundation trust by specialty(emergency admissions, aged 18 +)

2006/07 2007/08Specialty Discharges Deaths Mortality Discharges Deaths MortalitySurgical rate rateGeneral Surgery 2198 106 4.8% 2428 101 4.2%Urology 25 0 0.0% 24 0 0.0%Trauma & Orthopaedics 1172 52 4.4% 1190 61 5.1%ENT 73 0 0.0% 38 * 2.6%Oral Surgery * 0 0.0% 0 0 naAccident & Emergency 517 37 7.2% 261 19 7.3%Anaesthetics * * 33.3% 0 0 naOverall surgical 3989 196 4.9% 3941 182 4.6%MedicalGeneral Medicine 7897 774 9.8% 8482 845 10.0%Clinical Haematology 14 * * 27 * *Rehabilitation * 0 0.0% 0 0 naDermatology 7 0 0.0% * 0 0.0%Thoracic Medicine 377 48 12.7% 383 44 11.5%Neurology 0 0 na * 0 0.0%Rheumatology 73 * * 69 * *Paediatrics 0 0 na 8 0 0.0%Paediatric Neurology * 0 0.0% 0 0 naGeriatric Medicine 200 10 5.0% 115 10 8.7%Obstetrics 18 0 0.0% 31 0 0.0%Gynaecology 374 * * 447 * 0.7%Overall medical 8963 838 9.3% 9566 909 9.5%

Coding depthFigure 9 shows the mean number ofdiagnoses coded per episode at MidStaffordshire compared with other acutetrusts in England. Deeper coding is anindication of better quality coding, as morediagnosis codes give a more comprehensivepicture of a patients condition and treatment.While in 2006/07 quarter 1 Mid Staffordshirehad fewer diagnoses per episode than thenational average, by 2007/08 Q4 their codingwas deeper than England overall (4.4 codesper episode compared with 4.0 nationally).

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5

4

3

2

1

006/07 Q2 06/07 Q3 06/07 Q4 07/08 Q1 07/08 Q2 07/08 Q3 07/08 Q4

Quarter

Mea

ndi

agno

sis

Mid Staffordshire

England

06/07 Q1

Figure 9: Mean diagnosis codes per episode, 2006/7 Q1 to 2007/8 Q4 (emergencyadmissions, aged 18 +)

Note: England comparison excludes Mid Staffordshire NHS Foundation Trust

Methodology of measuring deviation ofmortality from a national standard

Cross sectional comparisons of standardisedmortality ratios

To assess the significance of observedmortality rates we indirectly standardiseagainst national mortality rates according tothe case mix of patients. A trust’s outcomesare compared against an expected value whichrepresents mortality at the national rate,allowing for differences in patient ages,gender and Healthcare Resource Group (HRG).We further standardise by time period(calendar quarter) so that comparisons arealways local to each period and effects ofseasonality and national trends are avoided.

If Oi represents observed mortality for patientsassigned a particular HRG within trust i, and Ei

the expected value, we calculate thestandardised mortality ratio (SMR) as onehundred times the ratio Oi/Ei. In this way, ifobserved and expected values are equal the

SMR has a value of 100. Values greater than100 indicate that observed outcomes arehigher than expected and, conversely,outcomes are lower than expected if the SMRis less than 100.

To assess the significance of deviations of theSMR away from the expected value of 100, weapproximately normalise the values using asquare root transformation and thenstandardise by subtracting the expected valueand dividing by the standard deviation. If wealso assume a Poisson distribution ofoutcomes, √(Oi/Ei has expected value of 1 and astandard deviation approximately equal to1/(2√Ei). The standardised normal variate, or z-score, is then calculated as:

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It is possible that due to insufficientbenchmarking or the presence of common-cause factors these values are over-dispersed,i.e. their true variances are greater than one.We therefore allow for such over-dispersion byassuming an additive random effects model.With this approach, a trust’s true expectedvalue is assumed to be distributed about thenational rate with standard error τ. For cross-sectional comparisons this involvesreadjusting the z-scores by calculating

where the Si is the standard error of √(Oi/Ei)assuming the national rate is true

Values for τ can be estimated with theformula:

where N denotes the number of trusts forwhich z-scores are calculated,

and

Before calculating τ and φ we Winsorise thedata by shrinking the most extreme z-scores.

Control limits for the adjusted z-scores, zi*can then be set at appropriate multiples of

These can also be converted back into controllimits for the SMRs.

Longitudinal comparisons of outcomes forspecific patient groups

To compare outcomes over time for specificgroups of patients we use the CUSUM, whichis a statistical process control (SPC) techniquethat is used to detect persistent deviationsfrom a reference value. This is a sequentialhypothesis testing approach by which evidencein favour of outcomes occurring at theexpected rate (the null hypothesis, H0) iscontinually weighed up against evidence that achange has occurred (the alternativehypothesis, H1). CUSUM control charts areplots of the cumulative log likelihood ratiobetween these two hypotheses. They are alsoconstrained not to fall below zero. So, forexample, if a CUSUM is designed to detectseries of outcomes that are worse thanexpected, it cannot build up credit for series ofgood outcomes. If the CUSUM exceeds apredefined threshold, or control limit, then thehypothesis of a change (H1) is accepted infavour of the null (H0) and this constitutes an‘alert’ or ‘signal’. After each alert, the CUSUMis reset to zero so that if any changessubsequently occur there is time for them totake effect. Alternatively, if poor outcomespersist then a further signal is likely to occurat a later time. Control limits have to be set toguard against too many ‘false alarms’occurring as a result of random variation, butnot be set at too a high a value that it becomesvery difficult to detect any differences inmortality.

s i + 2τ2

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i.e. a trust’s z-scores are normally distributedabout a local mean for that trust, θ k, withstandard deviation, σ. These trust mean valuesare themselves normally distributed aboutzero with standard deviation, τ. Theparameters θk, σ and τ can be calculated fromthe data.

To set a null hypothesis for the CUSUM we seta value for the local mean that is in the upperpart of its probability distribution, i.e.

where γ1 can be interpreted as a tolerancefactor for the mean. We are thus allowing theexpected value for a trust to be greater thanzero (see figure 10). This is tested against thealternative hypothesis:

Investigation into Mid Staffordshire NHS Foundation Trust158

Mathematically, if Ct denotes the CUSUMvalue and wt the log likelihood ratio at time tthen:

The values wt are called the CUSUM weights.

For series of outcomes we calculate the z-scores as for the cross-sectional analysis, butusing SMRs appropriate for the smallerpatient group. To allow for over-dispersiontheir distribution is modelled with ahierarchical structure: if zkt represents the z-score for trust k at time t,

With these assumptions the CUSUM weightsare calculated as:

where

For such a CUSUM it is possible to estimatesteady-state p-values which can then be usedfor setting a stopping rule based on the falsediscovery rate (FDR). They also enableconstant limits to be set that correspond topre-specified tails of the null distribution ofthe CUSUM. We typically use the limit thatcorresponds to the upper 0.1% tail of theadjusted z-scores, zkt (a CUSUM z-scoreapproximately equal to 3).

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-4 -2 0 2 4 6 8 10

Figure 10: Assumed distribution of z-scores for testing higher than expected mortality

Distribution of z -scoresunder the null hypothesiscentered on the nationalmean (zero) plus atolerance factor to allowfor over dispersion

Distribution of z -scoresunder the alternativehypothesis

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Mr M YeatesChief ExecutiveMid Staffordshire NHS Foundation TrustStafford HospitalWeston RoadStaffordST16 3SA

23 May 2008

Dear Martin,

As you know the Healthcare Commission is currently undertaking an investigation of apparentlyhigh death rates and concerns about poor nursing care at your trust. We visited the Accident andEmergency department from 20 to 22 May 2008, as part of the investigation.

As we explained on 26 March 2008, when we met with you and your Chair and members of yourexecutive and senior team, the Commission’s policy is to raise any issues of concern regardingthe safety of patients without delay, directly to the trust being investigated, rather than waitingfor our report to be drafted. This letter follows our meeting with you on 22 May and is formalnotification of the concerns of the Healthcare Commission about the emergency department.

The concerns cover three principal areas. These arise, in the main, from interviews,observations and other evidence gathered during our most recent visit (20-22 May) but are alsoinformed by other evidence collected so far during the course of our investigation. Whilst weaccept that our findings are therefore provisional, they are represented here following detaileddiscussion with the Commission’s specialist advisors, who were present during our recent visitand who have been a major influence in us raising these concerns with you at this time. As youare aware, these advisors include specialists in emergency medicine, nursing, governance,medicine and surgery as well as senior leadership in the NHS.

1. Staffing

It is the view of the Commission and its advisors that the department is understaffed in relationto medical and nursing staff.

There is a single-handed emergency consultant in Accident and Emergency despite the fact thatthe College of Emergency Medicine recommends that there should be a minimum of four. Thisconsultant appears not to be providing leadership to the department. The acute care physiciansprovide some support for the care of medical patients but cannot cover across the spectrum ofundifferentiated illness and trauma that presents at A&E. There are periods of time when themost senior person in the department is a doctor who, although experienced, has nopostgraduate qualification in emergency medicine. In the periods when the consultant is not inA&E the clinical accountability for patients is not clear.

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Appendix F: Letter from the HealthcareCommission to the trust concerning A&E, 23 May 2008

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There are insufficient middle grade doctors to provide adequate cover. The middle grade rota isnot robust, the hours are not compliant with the European Working Time Directive and neitherthe middle grades nor junior doctors get sufficient breaks. One long-term locum doctor worksonly at night and sometimes works a long sequence of (more than 10) consecutive nights.

The lack of sufficient senior and middle grade cover means that junior doctors in training do notget sufficient support and advice. There is virtually no educational activity and teaching sessionsare frequently cancelled, often for operational reasons. The lack of leadership, feedback onperformance and opportunities to develop has left the junior doctors demoralised, frustrated andconcerned.

There is also an inadequate number of nurses, with evidence that the current recruitment drivemay not only not increase staffing levels as intended but not compensate for those leaving orintending to leave.

There is no nurse leader with clear accountability for nursing and leadership. There is no regularappraisal, induction or preceptorship. There is low morale demonstrated via “distressed” staff,excessive hours, no meal breaks and turnover.

2. Structure and operation of the department

The recent refurbishment appears to have been a missed opportunity. Insufficient thought wasgiven to equipment and the department lacks trolleys that can be used in X-ray and has cardiacmonitors that can no longer be repaired. The current arrangements at reception are far fromsatisfactory, since the fixed windows mean that neither the staff nor patients can easily hearwhat the other is saying. Patients in the waiting room are largely out of the sight of staff.

We note that the trust performed poorly in the latest national survey of inpatients, including inrelation to waiting times, and privacy and dignity in A&E.

Effective initial assessment of patients is not in place. Although nurses have been trained intriage, the staffing situation means that they frequently cannot be released to triage patients.Receptionists are undertaking this function, placing patients who walk in to the department, inthe major or minor category. Those in the minor category may then wait for hours in the waitingroom. Particularly considering that patients in the waiting room are not clearly visible to eitherthe receptionists or nursing staff, we believe that this constitutes a serious risk.

The four-bedded area originally described as the CDU (clinical decision unit) is used for anumber of different types of patient. The staff that we spoke to are not clear about the existenceof a protocol for placing patients in the CDU. We have noted that the combined operational policyfor A&E and EAU with which we have been supplied is an undated first draft version and doesnot detail circumstances and arrangements for when patients are placed in either of the CDUs.Some patients stay overnight in the unit although it has minimal staffing, and during times ofpressure, patients may not be adequately monitored. Staff that we spoke to do not understandthe function of the ‘new’ (larger) CDU and are concerned that some of its nursing staff have beentaken from A&E.

There is no clear system to move patients through the department, and when the four-hour limitis approaching, junior doctors can be put under undue pressure to make quick decisions. This isparticularly undesirable given that there is often insufficient support from more senior doctors.On occasions, when the number of minor patients is significant and there are worries aboutbreaches, concerns have been expressed that nurse managers may pressurise the middlegrades to work in minors, rather than in majors or resuscitation where they may be neededmore.

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The department’s accountability and reporting lines appear to be unclear. This relates to anumber of areas: professional; managerial; and specialty.

3. Governance

There are few protocols or pathways in use in the department, and those that are in use are notaudited. There is little use of data to monitor performance (other than the four hour target) andvery little clinical audit. When audits have been done, e.g. of the adequacy of pain relief inchildren, they appear not to have been acted on, even though the results showed anunsatisfactory situation.

There are no multidisciplinary meetings for staff in the department to reflect on theirperformance and consider improvements. There are no meetings to discuss mortality ormorbidity, or near misses and little opportunity to learn. Junior doctors rarely get feedback ontheir performance.

In summary, there appears to be an almost complete lack of effective governance.

Although we noted some positive factors, such as the presence of an occupational therapist inthe department, our judgement is that the staffing shortages, operational problems, and lack ofleadership and governance mean that, despite the efforts of staff, the quality of care iscompromised and that this constitutes a risk to the safety of patients.

The Healthcare Commission requires you as a matter of urgency to consider these matters andtake steps to address the shortcomings outlined in this letter. Given the seriousness of theseissues, I should be grateful to receive a formal response from the trust no later than Tuesday3rd June. We will write to you again as soon as we have had the opportunity to consider yourresponse.

I am copying this letter to South Staffs PCT and the West Midlands SHA, and have also askedcolleagues in the Healthcare Commission to pass a copy on to Monitor and the Department ofHealth to ensure that all of these bodies are informed of the concerns set out in this letter.

If you would like to discuss the content of this letter in more detail, please do not hesitate tocontact me.

Yours sincerely

Dr Heather Wood Investigation ManagerHealthcare Commission

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Mr M YeatesChief ExecutiveMid Staffordshire NHS Foundation TrustStafford HospitalWeston RoadStaffordST16 3SA

7 July 2008

Dear Martin,

As you know the Healthcare Commission is currently undertaking an investigation of apparentlyhigh death rates, particularly relating to patients admitted as emergencies, and concerns aboutpoor nursing care at your trust.

As part of any investigation we invite feedback from patients, relatives and members of thepublic who have experience of the services at the trust that we are investigating. Thus far wehave heard from over 100 individuals, and relatives and patients continue to contact us. Thisletter follows our analysis of the majority of the information that we have so far received. Whilstwe accept that our findings are therefore provisional, they are represented here because themessages are very consistent.

The reason we are writing is to ensure that you are aware of the concerns and to ask you toaddress any that are not currently part of your plans to increase staffing levels and improveservices. At this point this letter does not require a response, other than on the specific issue ofmedication.

The concerns that have been expressed to us cover a number of areas. Most stakeholders hadseveral issues they wanted to raise and many relate to experiences at your trust within the last year.

The first area of concern relates to basic nursing care and covers such matters as the supply of,and help with food and drink; a timely response to call bells and buzzers; attention to thehygiene needs of patients; and respecting the privacy and dignity of patients. A related area isthat of cleanliness, hygiene and infection control. Concerns about these matters occurred in overhalf of the feedback we received.

The second area relates to medication. A number of patients and relatives noted that patientswere not given the correct medication or were given incorrect medication. This issue wasreferred to in a third of feedback. In several instances patients were not helped to take theirmedication. In others patients were taken off or not given their routine medication when theycame into hospital and this appeared to have adverse consequences for their health. We areaware that this was also an issue that the trust had itself discovered in at least one seriousuntoward incident and in its review of jejunal operations. We would therefore like to know aboutany improvements the trust has made or is planning to make in this area. It would be helpful tohave a progress report on this by the end of July.

Appendix G: Letter from the HealthcareCommission to the trust about concerns raisedby patients and relatives, 7 July 2008

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The third area related to failure of clinical care such as nurses completing charts, weighingpatients, checking intravenous infusions, dressing wounds, avoiding pressure sores etc. Theseconcerns also featured in about a third of feedback. About a third of patients or their relativeswere distressed by delays in admission from A&E or delays in diagnosis and treatment. Otherswere upset by transfers within the hospital, often late at night.

Another major area related to problems with communication with relatives, and with thecomplaints process and difficulties in getting a response. Over a third of stakeholdersmentioned these issues.

We note that many of these areas of concern correlate with the findings of the 2007 inpatientsurvey.

If you would like to discuss the content of this letter in more detail, please do not hesitate tocontact me.

Yours sincerely

Dr Heather Wood Investigation ManagerHealthcare Commission

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Mr M YeatesChief ExecutiveMid Staffordshire NHS Foundation TrustStafford HospitalWeston RoadStaffordST16 3SA

15 October 2008

Dear Martin,

This is to follow up the discussion at our meeting on 9 October 2008, after the formal interviewshad been concluded.

As we explained then, we hope to be able to send you the draft report before Christmas for thetrust to check factual accuracy. In advance of the report we wanted to tell you some key areaswhere we have ongoing concerns about the experience of patients and where we think you needto concentrate efforts in the interim to improve clinical services.

These matters are not as urgent as those in A&E where we felt there was a deteriorating andpotentially unsafe position, but none-the-less they need attention, and we therefore wanted toinform you about them without delay. We have derived our information in the main fromobservations and interviews and other evidence gathered during our site visits, and we are havealso been informed by other evidence collected so far during the course of our investigation. Aspreviously, our views are represented here following discussion with the Commission’s specialistadvisors.

It is important however to stress that what follows is not the definitive list of concerns, or thesole areas where action needs to take place. It represents those requiring immediate focusbefore you receive the draft report.

We feel that the trust needs to concentrate on the emergency care pathway and within that,there are three principal clinical areas of concern, and one further issue that is related tomodelling and use of specific care pathways

1. Emergency Admissions Unit (EAU)

It is the view of the Commission and its advisors that the Emergency Admissions Unit isgenerally understaffed in relation to medical and nursing staff, given the case mix of patients inthe Unit. Currently the unit receives medical (including stroke and cardiac), surgical, gynaecologyand trauma patients.

As well as concern about the actual number of registered nurses, we also have concerns aboutwhether all the nursing staff on EAU have adequate training for this busy multispecialty ward. Itis clear there has been a longstanding deficit in training in this unit.

Appendix H: Letter from the HealthcareCommission to the trust following the conclusionof formal interviews, 15 October 2008

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As you know, we have previously communicated about this and we understand that work isunderway to raise skills. Our original concerns covered poor recording of fluid balance and inparticular the inadequate reconciliation of input and output; the failure to use pumps forintravenous infusions; the failure to conduct observations in a timely manner, and/or tocomplete a modified early warning score (MEWS) accurately. We also had cause to questionwhether staff were clear about how to act on MEWS appropriately. The recruitment drive mayhave marginally increased staffing levels but there are many newly qualified and inexperiencedstaff on the unit. We are particularly concerned that the monitored area on EAU is still beingstaffed by nurses some of whom have not been trained or assessed as competent in the use ofcardiac monitors.

We know that patients often stay on the Unit in excess of the anticipated 72 hours and may bethere for four or five days. This strongly suggests that the functions of EAU as both anassessment area and short stay facility have not been effectively matched against the expectedwork load. We noted that some of the eight beds on EAU that had been closed following our firstvisit, had been opened for at least a week due to bed pressures and we were concerned aboutthe effect of this on the staffing of EAU, and hence on the quality of care.

There are few multidisciplinary meetings for staff in the Unit to reflect on their performance andconsider improvements. There are no meetings to discuss mortality or morbidity, or nearmisses and little opportunity to learn. There are concerns about continuity of care and juniordoctors rarely get feedback on their performance.

2. Trauma patients

We have a number of concerns about trauma patients. These worries start in A&E and arerelated in part to the seniority of medical staff making assessments out of hours. We havementioned above the skill mix of nurses on EAU and this is especially relevant in the case ofpatients admitted with traumatic injuries, where regular and purposeful observation isextremely important and appropriate equipment for traction should be readily available. There islimited input from orthogeriatrics to EAU or other wards.

Another significant issue is the insufficient theatre time for emergency cases, particularly atweekends. Trauma patients are competing with general surgical emergencies and are oftenlosing priority, so they may have to wait a number of days for their operation. During this timethey are often on the EAU or outlying on other wards where the nurses are not skilled traumanurses used to dealing with the particular needs of these patients. We have encountered anumber of cases of significant preoperative delays and cancelled operations, with patients beingnil-by-mouth for several days.

The lack of beds on the trauma wards also means that postoperative trauma patients are notalways cared for on the trauma ward and onward rehabilitation and care for frailer peopleseems to take a long time to organise.

3. Surgical cover out of hours

The third area that we raised with you was the lack of senior surgical cover on site after 9pm.

The Resident Surgical Officers (RSOs) are called to A&E and may also be asked to attend thewards or scrub for theatre. They have to cover trauma, general surgery and gynaecology. In thecase of general surgery there is no other cover other than the consultant who is not on site.

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The RSOs have variable knowledge and experience. The group includes some very junior doctorswhose sole surgical experience is four months at FY1 level.

It is frustrating for senior and middle grade staff in A&E to have to ask for general surgicalopinions from staff who are frequently considerably less experienced than they are themselves.

We are concerned that such junior staff may well be reluctant to call the consultant generalsurgeon during the night, preferring to put off decisions until the morning.

We would ask you to revisit the seniority of surgical cover on site, out of hours.

4. Use of care pathways and capacity modelling for emergency admissions

There are few protocols or pathways for unscheduled care in use in the trust, and those that arein use are not audited. There is little use of data to monitor performance and little clinical audit.

It would be helpful for the trust to review its unscheduled care activity and develop models of thepattern of demand for emergency admissions in order to predict the admission of patients and todevelop sensible pathways for the common important types of emergency.

The Healthcare Commission suggests that you consider these matters and begin to take steps toaddress them.

I am copying this letter to Monitor, the Department of Health, South Staffs PCT and the WestMidlands SHA, for information only.

If you would like to discuss the content of this letter in more detail, please do not hesitate tocontact me.

Yours sincerely

Dr Heather Wood Investigation ManagerHealthcare Commission

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• A patient and public engagement strategyhas been developed and is beingimplemented through the patientexperience group. This group is multi-professional and has patient and publicinvolvement.

• An establishment and skill mix review ofthe whole nursing and midwifery workforcehas been undertaken. The reviewconcentrated on ensuring the provision ofan appropriate workforce with the rightlevel of clinical leadership at ward level.

• Recruitment to the agreed investment hasbeen undertaken.

• A review of the nursing structures in thedivisions has been undertaken andculminated in the line managementresponsibility for nursing moving.

• Increase in matron posts from three to 12to ensure clinical leadership at ward level isenhanced.

• An annual recruitment plan has beendeveloped.

• Dashboards used in the clinical areas usedto chart progress against ‘nursing’performance indicators have been reviewedand refined. A balanced score card thatreflects quality has been developed (andwill develop further in time) this has beenpresented to the board and will be reviewedquarterly by the board.

• ‘Essence of care’ is being implementedagainst a defined rollout programme.Progress is reported at the divisionalgovernance groups and the clinical qualityand effectiveness group.

• ‘Quality rounds’ are carried out by thematrons and the deputy director of nursing.In addition to ad hoc clinical visits thedirector of nursing has clinical days duringwhich all clinical areas are visited.

• A nurses forum is held every six weeks atwhich issues relating to quality and thepatient experience are discussed. Theforum is open to all bands of nursing staff.

• Matrons meetings are held fortnightly.

• Guidance relating to the role of the nurse incharge has been developed.

• A process for standardising practice andcompetence associated with nursingclinical expanded procedures across thetrust has been developed.

• A decision tree for action to be takenfollowing nursing drug errors has beenimplemented. This includes re-assessingclinical competence following drug errors.

• There is zero tolerance in relation to poorprescribing practice.

• The Age Concern Volunteers pilot that wascarried out in Cannock Hospital has beenexpanded to cover the Stafford site.Recruitment to this project is progressingwell.

• There has been investment in learning anddevelopment and this has includedrecruitment to a clinical skills training post.This post has allowed a clinical skillsprogramme to be developed.

• A series of ‘confidence in caring’ study dayshave been held – for all grades of nursingstaff. These days have focused on quality ofcare, infection control and customer care. Arelative has been instrumental in deliveringthese study days.

Appendix I: Developments in nursing at thetrust from early 2007 to early 2009, as suppliedby the trust

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• The 2008 director of nursing study days areunder way – these are focusing on qualityof care and documentation. Thedocumentation sessions are being deliveredby Bond Solon – Documentation on Trial.

• Training sessions relating to the MentalCapacity Act and learning disabilities havebeen delivered.

• A series of elderly care champion studydays have been held.

• A training plan for nursing and therapistshas been developed and implemented

• Funding has been secured so that theProductive Ward can be implemented in twopilot areas. A bid for additional funding hasalso been submitted and has beensuccessful. This will allow the programmeto be rolled out across the trust.

• Funding for additional developmentopportunities has been secured. Funding isdetailed below:

Coaching: £37,500Leadership: £40,000Infection control training: £25,000Being Open training: £5,000SHA – Productive Ward pilot: £50,000Sign Off mentor training: £5,000 Customer care training: £12,000Clinical Skills Training Equipment: £34,000Increasing mentoring capacity: £10,000

• The director of nursing writes to allrelatives of deceased patients and offersthem to opportunity to discuss any issuesrelating to care that they may have.

• A document that sets down expectedbehaviour of the trust’s staff has beendeveloped through the nurses forum and isbeing formatted for trust-wideimplementation.

• Monthly quality rounds with thecommissioners are in place.

• A nursing audit schedule is in place.

• Staffing escalation plan has beendeveloped.

• Dr Foster’s Real Time Patient ExperienceTrackers have been purchased and a cycleof real-time reviews is being implementedwith results presented to the board.

• A review of the clinical nurse specialistshas been carried out and the findingspresented to the board.

• The advanced practitioner for pain hasmoved from the surgical division to thecorporate nursing team to ensure a trust-wide pain service will be reviewed.

• Unannounced visits to clinical areas are inplace. These visit are conducted by trustgovernors, matrons and externalhealthcare professionals.

• Divisional patient and carer councils arebeing set up in the divisions to promotepatient and care involvement. A launchevent has been held and was attended byapproximately 35 interested parties. Thoseinterested have expressed interest inspecific divisions.

• A corporate professional developmentnurse post has been created and the postholder will commence shortly.

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