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The Newcastle upon Tyne Hospitals NHS Foundation Trust

Point-of-Care Testing (POCT) Trust Policy

Version No.: 2.0

Effective From: 08 January 2019

Expiry Date: 08 January 2022

Date Ratified: 18 December 2018

Ratified By: Clinical Policies Group

1 Introduction This policy is designed to ensure that the Point-of-Care Testing (POCT) service within the Trust is managed and quality assured in accordance with national guidelines and accreditation standards. All POCT within Newcastle upon Tyne Hospitals NHS Foundation Trust is subject to strict governance and must be performed to the same quality standards as all testing undertaken within the United Kingdom Accreditation Service (UKAS) accredited Blood Sciences dept. laboratory. It is implicit that POCT strives to achieve international standard: ISO22870 for all devices used throughout the trust and is compliant for ISO15189:2007. The policy is also designed to ensure that the introduction of new POCT technology within the Trust is appropriate and consistent. In keeping with the trust vision to be “a leading national healthcare provider”, POCT can deliver pioneering services which can shorten waiting times and length of stay within the patient pathway, whilst also improving the quality of care within the patient experience. Potential advantages include:

Improved turnaround time – mainly by shortening pre & post analytical steps

Potential for better monitoring of certain conditions where frequent testing is desirable

Smaller sample volumes – POCT methods may be less clinically invasive

Advantageous in remote areas where access to a laboratory is limited

POCT may offer easier access to services e.g. for the elderly

Economic – although POCT is generally more expensive than conventional laboratory testing; it may offer wider economic benefits with a reduced number of clinic visits, reduced length of stay in hospital and fewer hospital admissions

Greater patient involvement and empowerment in the management of their own care

Improved patient experience

Availability outside of normal laboratory core hours and outside of hospital environment

NB Information on Quality Standards and Quality Management within Laboratory Medicine directorate available upon request to POCT Manager.

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2 Scope The policy applies to all staff using or maintaining POCT devices throughout the Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH). Patient owned devices that are commercially available are not covered within this policy and under no circumstances are the results from patient devices to be used in clinical decision making. Trust POCT devices are intended for use by ‘healthcare professionals’ and maintain an inbuilt audit trail of their use. The Trust recognises the importance of empowering patients undertaking self- management of long term conditions and they are able to ‘self-monitor’ using their own devices whilst at hospital, however this should occur in addition to staff using trust POCT devices – any abnormal results flagged from patient devices should be confirmed using diagnostic services recognised by the trust e.g. conventional laboratory testing or trust standard POCT device.

3 Aims The aim of this document is to provide guidance for safe and effective management and use of POCT systems that are fit for their intended purpose, used by a competent individual on the correct patient, giving quality assured results which become part of the patient’s record. 4 Duties (Roles and Responsibilities)

Diagram 1 – Organisational structure of POCT

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4.1 Chief Executive and Trust Board

The Chief Executive and Trust Board have responsibility for the safety and welfare of all Trust patients, visitors and staff. This includes overall responsibility for POCT devices used within the Trust.

4.2 Medical Devices Steering Group This group reports via the Clinical Risk Group to the Trust Board, and is responsible for developing, implementing and monitoring compliance with the ‘Medical Device Management’ policy to ensure best practice. The group is required to produce an annual report and action plan on the efficacy of the policy which includes POCT management.

4.3 POCT Committee (appendix 2) Chaired by the POCT Manager the committee will:

Lead and coordinate POCT activities for the Trust in conjunction with the Trust’s key objectives

Coordinate the implementation and management of POCT devices

Maintain training records of all POCT operators throughout the Trust

Coordinate the provision of External Quality Assurance (EQA) schemes where possible, review EQA performance and offer advice on the improvement of poor performance

Provide advice and help with documentation to Managers of areas on policies, operating procedures, training and competencies

Coordinate staff education and facilitate training for all POCT devices

Undertake Risk assessments for POCT devices where appropriate

Lead and coordinate the validation of new POCT devices before implementation

Provide evaluation of the performance of POCT equipment

Coordinate audits and inspections to provide Trust assurance of quality patient care and value for money

4.4 Laboratory Staff

Laboratory staff provide assistance where applicable in the maintenance of some devices, the management of EQA schemes, distribution of specific QC material and numerous administrative tasks regarding POCT. There is no formal out-of-hours support of any kind provided by the laboratory; within core working hours a consultation approach to troubleshooting will be applied where the details and extent of involvement vary on a case-by-case basis. The laboratory cannot guarantee being able to second staff to clinical areas to assist in every troubleshooting requirement throughout the trust. The extent of laboratory staff responsibilities are detailed in ‘Intra-Departmental Agreement for using Point-of-Care Testing (POCT) Devices’ (appendix 4).

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4.5 All Staff

Individuals must be trained and assessed as competent to use the POCT device by undertaking POCT service recognised training prior to patient testing. The procedure for recording the acquired competency is via the ‘My Medical Devices’ self-certification system, as per the Safe Use of Medical Devices Trust Policy (See section 6.3) Wards and departments who use POCT devices are the ‘owners’ and are wholly accountable for ensuring they function correctly and are safe, accurate and reliable pieces of analytical equipment. They must also adhere to the policy in regards to dealing with faulty equipment (section 6.5); these responsibilities are described in the ‘Intra-Departmental Agreement’ which is signed between clinical area and laboratory when a new POCT device is implemented (appendix 4). Explanation of the testing process and verbal consent must be taken prior to any analytical POCT investigation and operators undertaking this consent must adhere to trust policy. Communication support should be provided to obtain consent where this is required. 5 Definitions

Term Definition

Connectivity The use of IT links to interface POCT devices with laboratory and hospital IT systems. This should normally allow the transfer of patient and/or QC results and sometimes the remote control of device screens

Device Any POCT instrument being used within Newcastle upon Tyne Hospitals NHS Foundation Trust

External Quality Assessment

A means of validating results and assessing accuracy after they are issued and usually uses samples whose value is unknown to operators

Internal Quality Control

A means of validating results before they are issued

MHRA Medicines and Healthcare products Regulatory Agency

Operator Member of clinical staff trained and deemed competent to carry out POCT

Point-of-Care testing (POCT)

Point-of-Care Testing is defined as “Any clinical test performed on a patient’s sample undertaken by a healthcare professional outside the conventional clinical lab.”

Quality Control Techniques and procedures that monitor performance characteristics

UKAS The United Kingdom Accreditation Service (UKAS) is the national accreditation body for the United Kingdom, appointed by government, to assess organisations that provide certification, testing, inspection and calibration services

http://policies.app/Launchit.asp?launchit=731


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6 Process

6.1 Rationale for the use of POCT Analysis of constituents in blood and other body fluids is a vital part of the decision making process associated with the diagnosis and management of disease. Typically specimens are sent to a laboratory for analysis with the results being returned by telephone, electronically or with a hard copy report. In some cases delays caused by sending the specimen to the laboratory are unacceptable to the clinical and/or operational situation; in these circumstances testing at the bedside, in the clinic or GP surgery is preferred. This type of testing is termed ‘Point-of-Care’ testing (POCT). Improvements in technology have permitted a number of analyses, which previously could only be performed in the laboratory, to be carried out at the bedside or in the clinic. Like all new technologies, however, the apparent simplicity of POCT often belies its complexity and masks the need for attention to detail in order to achieve optimum and accurate results. Situations in which POCT may be appropriate include:

a) Where clinical management in an acute or life threatening situation may be aided by the result of a diagnostic test

b) Where availability of the result in the clinic may enable more effective counselling of the patient and/or change in therapeutic management

c) Where the total attendance time for the patient can be reduced d) Where the clinician can assess the patient and initiate or change subsequent

management in a single visit

6.2 Implementing New POCT Methods Details of POCT equipment that members of staff wish to be considered for acquisition and implementation should be outlined on the proposal form found in Financial Process Notes 9 – appendix 3. This form is submitted to both the finance team and POCT Committee for approval. The process of implementing a new POCT method is described in appendix 1. Devices acquired from clinical areas outside of this process will not be recognised by the laboratory and therefore not supported in any way.

6.3 Training Individuals who have been trained to the ISO22870 standard must be registered with the POCT service in order to become competent operators. Training should include aspects of maintenance, troubleshooting, sample collection/preparation, demonstration of the proper use of equipment in accordance with the manufacturer’s specification, the consequences of improper use, internal quality control, basic understanding of the significance of results obtained and health

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and safety. All users must follow the related protocols and guidelines associated with the devices and should understand the methods contraindications and limitations. Competence in using POCT devices is achieved via IInniittiiaall TTrraaiinniinngg – this constitutes face-to-face training by either attending a timetabled training session or with a recognised ‘Cascade Trainer’. Following face-to-face training, for some POCT devices there will be a requirement for competencies to be assessed in form of short multi-choice questions to be completed by the trainee and sent to back to the POCT team via email or post; training records will only ever be updated once these completed forms have been received. RReeffrreesshheerr TTrraaiinniinngg is required every subsequent two years to maintain that competency – this can be achieved through the face-to-face training routes described previously or by completing eLearning on ESR – there will be no competency assessment forms required to be completed when undertaking eLearning. The POCT service compile and maintain operator training records through the timetabled training session sign-off sheets, eLearning course statistics and cascade trainer updates through the dedicated cascade trainer update webpage. In using the cascade trainer update webpage to communicate training undertaken to the POCT service; the individuals completing the form must comply with the Information Governance Trust Policy as it is deemed fraudulent for any staff member to impersonate another. Some devices may have access permissions where only trained operators can use them by scanning in their ID badge barcode (payroll number) – if an operator (trained or untrained) uses any other ID badge apart from their own to analyse patient samples this will be deemed fraudulent activity and evidence for subsequent disciplinary action. The POCT service will endeavour to provide training programmes that are realistic and readily accessible for all devices. It is the responsibility of the POCT Manager to ensure operators know what training is required to maintain competency - this is detailed within the POCT Intranet page. Following the completed training in the POCT device; the operator must ensure they ‘self-certify’ the newly acquired competency via ‘My Medical Devices’ as per the Safe Use of Medical Devices Trust Policy (See diagram 2). Any staff member that ‘self-certifies’ the competency for using a POCT device via ‘My Medical Devices’ without undertaking the recognised POCT service training will not be deemed competent and should therefore not use the equipment. Line managers throughout the clinical areas must ensure that all POCT devices used are recorded on the ‘My Medical Devices’ inventory and to agree with individual members of staff which of them they are expected to be trained in and use. They must also make sure that all users complete accurate competency records.

http://nuth-vintranet1:8080/cms/SupportServices/PointofCareTesting/CascadeTrainer.aspx



http://nuth-vintranet1:8080/cms/SupportServices/PointofCareTesting.aspx



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Diagram 2 – Flow chart explaining how to record training and competency in using

POCT devices

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6.4 Control Schemes The analytical performance of devices must be sufficient for clinical requirements and rigorously controlled using both Internal Quality Control and External Quality Assurance (EQA) systems where possible. The results of these independent checks must be recorded and available for inspection. POCT devices must undergo appropriate routine maintenance to ensure result validity. Devices and their use must conform to national and international standards for the Health & Safety of both the patient and trust staff. 3x successive events of where the clinical area has ‘non-returned’ their EQA results back to the laboratory constitutes ‘poor performance’ and will be flagged by the POCT service and investigated by the POCT manager accordingly. Devices which been highlighted as ‘poor performance’ (e.g. discrepant results compared to the general population and the EQA schemes acceptable limits, or alternatively, persistent non-returned results) may be removed in regards to ensuring patient safety due to the accuracy and reliability of the results produced being unverified.

6.5 POCT Consumables It is the responsibility of the POCT Manager to ensure operators are aware where consumables are sourced from and how they are stored; depending on what the consumable actually is - this could include the clinical area purchasing them directly from Pharmacy Stores, via non-stock requisition or alternatively the POCT service regularly distributing them (e.g. glucose meter IQC solution). The clinical area must ensure that they hold adequate stock levels of consumables with expiration dates that are kept valid and stored in correct conditions.

6.6 Patient Meters Distributed by Trust The trust may issue patients with certain POCT devices upon discharge to allow specific analytical monitoring to continue at home. These devices will be distributed by specialist nurses who are responsible for training the patient or parent/carer in the correct use. These devices are strictly for home use by the patient or parent/carer; the trust is not responsible for the devices maintenance, troubleshooting or performance monitoring

6.7 Faulty POCT Devices Genuinely faulty devices must be reported to the POCT service as per the 'Medical Device Management Trust Policy'. Reporting a faulty a device is achieved by completing the webpage form via the POCT Intranet page ‘Log a fault with POCT device’. All faulty devices must be taken immediately out of general usage and have a 'Declaration of Decontamination Status of Healthcare Equipment Following Patient Use and/or Prior to Service or Repair' form completed following appropriate decontamination. As per the ‘Intra-Departmental Agreement' (appendix 4) it is the responsibility of the operators within the ward / Dept. to ensure the POCT devices are looked after and appropriately used; neglected devices pose a threat to patient safety and can be

http://nuth-vintranet1:8080/cms/SupportServices/PointofCareTesting/Whattodowithfaultydevices/logafaultwithPOCTdevice.aspx


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reported to the Infection Prevention and Control team or even removed from clinical area. If the faulty device has been involved in a clinical incident or near-miss a DATIX must be raised - the DATIX reference number should be included within the 'Declaration of Decontamination' form mentioned previously. Once reported, the POCT service will provide instructions on how to correct the fault with an aim to having it back in use as soon as possible, if this is not possible a replacement device will be arranged via collaboration between the POCT manager and senior ward staff. Regardless of the state of the device, under no circumstances are individuals to dispose of or replace the equipment themselves.

TTHHEERREE IISS NNOO SSUUPPPPOORRTT PPRROOVVIIDDEEDD OOUUTTSSIIDDEE OOFF CCOORREE WWOORRKKIINNGG HHOOUURRSS ****

**** CORE WORKING HOURS: MONDAY – FRIDAY 0830 - 1700

Within core working hours the laboratory cannot guarantee being able to second staff to clinical areas to assist in every troubleshooting requirement throughout the trust. See the flow chart below for what to do in events of faulty POCT equipment

Diagram 3 – What to do with faulty POCT equipment & Support offered by Blood Sciences

Business continuity plans for non-functioning equipment include:

11)) … Initial troubleshooting

22)) … Locating a loan device using inventory spreadsheet on Intranet page

33)) … Sending samples to the laboratory for conventional testing

The assigned deputy for the POCT Manager in case of absence/annual leave is the Blood Sciences Dept. Laboratory Manager


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6.8 Connectivity Connecting POCT devices to Laboratory Information Management Systems (LIMS) and subsequently electronic patient records (eRecord) allows remote analytical analysis of patient samples to be interpreted by clinical staff automatically without the requirement of paper based reporting systems and the problems such as accessibility of patient notes and the transcription errors that accompany them. The ePrescribing of insulin and connectivity of POCT glucose meters is a prime example of the importance of this functionality. Not all POCT devices will be connected and so records must be kept to identify the results produced by POCT devices. Patients requiring a Point -of-Care test must be identified by a via medical record number and all paper based results must be noted in patient notes or log book – information such as operator ID, date, time and QC results are also required. 7 Health and Safety The following legislation and guidance applies equally to all laboratories and other sites where POCT is performed, irrespective of size or location:

Health & Safety at Work Act 1974

Consumer Protection Act 1987

Control of Substances Hazardous to Health Regulations 2002

Staff performing POCT must be aware of the microbiological hazards of samples from patients, the chemical hazards of reagents and the physical or electrical hazards of equipment. Suitable and sufficient risk assessments must be carried out before equipment is commissioned. It is the responsibility of the ward/dept. staff to ensure all POCT equipment is kept clean and decontaminated. Any incidences of blood-stained or unclean equipment must be reported to the Infection Prevention and Control team as an infection control hazard; this may result in the device being removed from general usage on the grounds of patient and staff health and safety. 8 Equality and Diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This document has been appropriately assessed.

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9 Monitoring Compliance

Standard / process / issue Monitoring and audit

Method By Committee Frequency

Organisations providing acute and community services must have an approved documented process for managing the maintenance of reusable diagnostic therapeutic equipment

Maintain inventory of all POCT devices in ‘Asset’ module of Q-Pulse.

POCT Manager

Lab Med Clinical Governance & Quality Committee

Annual report

Review all POCT related competencies and clinical incidents, near-misses throughout trust

Review My Medical Devices and CGARD statistics

POCT Manager

Medical Device Steering Group

Bi-monthly meeting

10 Consultation and Review The Point-of-Care Testing Trust Policy has been prepared following consultation with the POCT Committee, Laboratory Medicine Executive and Medical Devices Steering Group and will be reviewed bi-annually in line with the document control procedures within Blood Sciences Dept. Quality Management System. 11 Implementation (Including Raising Awareness) Implementation of policy requires communication between laboratory and clinical areas – the collaboration between the two is essential for successful usage of POCT devices. Distribution of information and learning resources is made possible via dedicated POCT Intranet page (search ‘POCT’ in A-Z), enabling troubleshooting support out-of-hours, and training resources such as training timetables and links to eLearning assessments. The successful implementation of this policy will be dependent on a robust training and registration scheme for operators. 12 References Management and Use of IVD Point-of-Care Test Devices, MHRA, December 2013 13 Associated Documentation Financial Procedure Note 9

Medical Devices Management Trust Policy Safe Use of Medical Devices Trust Policy Information Governance Trust Policy 'Declaration of Decontamination Status of Healthcare Equipment Following Patient Use and/or Prior to Service or Repair' NB Available via Freeman and RVI Loan Libraries Consent for Examination or Treatment (with reference to the Mental Capacity Act 2005)







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Appendix 1 – Flowchart Illustrating Implementation of New POCT Method

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Appendix 2 – POCT Committee Terms of Reference

Point of Care Testing Committee

Terms of Reference

Purpose The Point of Care Testing Committee will be an official sub-committee of the Medical Devices Steering Group. It will oversee the planning, implementation and operational review of the Trusts’ Point of Care Testing devices. The Committee will be responsible for ensuring the Trust meets the requirements of the Point of Care Testing and Medical Devices Management Policy and UKAS Standards for Point of Care Testing. Terms of Reference The establishment of a Point of Care Testing Committee will improve communication on point of care testing (also referred to as near patient testing) issues within the Trust. The Point of Care testing Committee will ensure that the Trust’s point of care testing management arrangements conform to the requirements of the Point of Care Testing and Medical Devices Management Policy. The Point of Care Testing Committee will identify and implement strategies as required to meet the standards on point of care testing set by the MHRA and UKAS. The Point of Care Testing Committee will monitor the training and education of staff using point of care testing devices and evaluate the training strategies used. The Point of Care Testing Committee will ensure that strategies are in place for clinical governance of point of care testing. The committee will monitor point of care testing issues and identify potential improvements or best practice, thereby reducing risk to patients. The Point of Care Testing Committee will review point of care testing device evaluations and recommend acceptance/rejection as Trust standard device. The Point of Care Testing Committee will review quality assurance performance and quality control audit of point of care testing devices. Poor performance issues will be escalated to the Medical Devices Steering Group. The Point of Care Testing Committee will monitor the cost and clinical effectiveness of point of care testing within the Trust. The Point of Care Testing Committee will meet bimonthly.

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The Point of Care Testing Manager or their nominated representative will chair the Point of Care Testing Committee. Three members of the committee will constitute a quorum. Deputies may be appointed to represent members who are unable to attend. The committee will be composed of members representing the main clinical areas using point of care testing and the primary support services. Other Trust staff may be co-opted onto the committee when necessary, or may be asked to provide expert advice and help on specific issues that may arise. The Point of Care Testing Committee will submit minutes and action plans to the Medical Devices Steering Group. The terms of reference will be reviewed annually in order to monitor the performance and effectiveness of the group.

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Appendix 3 – FPN 9 Appendix C Proforma for new POCT Method Implementation

FPN 9 Appendix C DIRECTORATE PRIORITIES EQUIPMENT PROFORMA –

TO COMPLETED PRIOR TO CAPITAL REQUISITION

Directorate

Person making request (include name, department, telephone)

Date completed

1. DETAILS OF THE EQUIPMENT

Manufacturer

Model

Price (to be supplied via supplies & procurement )

Has this equipment been requisitioned by any other route?

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2. OUTLINE CASE OF NEED

Why is the equipment needed? ( Include information on clinical and financial benefits)

Who will use the equipment? Are there any training implications?

Approximately how many patients a year will this equipment be used on per year?

3. POTENTIAL RISK OF NOT PROVIDING

What, if any, are the potential clinical risks of not providing this equipment? Include any details re national drivers/NPSA alerts.

What are the potential financial risks of not providing this equipment including a loss of market share?

How do you quantify the overall level of risk using the Trust Risk Management matrix?

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4. PROCUREMENT METHOD

Has lease versus purchase been evaluated and what is the outcome?

5. FINANCIAL IMPLICATIONS

DESCRIPTION YEAR 1 COST RECURRING FOR FYE

Capital

Revenue Lease Cost

Clinical Staff Cost

Nurse Cost

Other Staff Cost

Consumable Cost

Maintenance Costs (to be agreed with Estates Dept.) You must indicate cost centre these costs are to be allocated to.

6. OTHER IMPLICATIONS

Please detail any other implications e.g. enabling costs

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Appendix 4 – Intra-departmental agreement

Intra-Departmental Agreement for using Point-of-Care Testing (POCT)

Devices

This document outlines the expectations of the Blood Sciences Dept. (within Laboratory Medicine

directorate) and the clinical area which is using Point-of-Care Testing (POCT) devices. The clear

documentation of working relationships provides the basis of an agreement, defining the terms of

collaboration between the:

POCT Office Blood Sciences Laboratory, Leazes Wing Royal Victoria Infirmary

AND Insert hospital site and ward / dept.

The scope of this agreement includes all procedures undertaken using the following devices…

Device Serial Number Asset ID Maintained By? e.g. Accu-Chek Inform II Glucose Monitor

UU12345678 12345 Lab or Ward/Dept.?

If more space is required please attach another sheet ****** If the listed devices become faulty and have to be replaced; the new devices will automatically fall under

the same ‘agreement’

Information on POCT devices is available via contacting the POCT team on

[email protected] or via accessing the POCT Intranet page. Documentation on the

specific device, user reference guides and ad hoc training can be arranged upon request and regular

scheduled meetings regarding POCT can be used as an opportunity for ward staff to raise issues

affecting POCT; information on meeting times/dates is available upon request.

The successful collaborative relationship between clinical areas and laboratory requires constant

communication regarding all aspects of how POCT devices are managed and clearly understanding

lines of accountability. By signing this document both parties understand the distribution of

responsibilities outlined on the next page

On behalf of Blood Sciences

On behalf of the POCT device’s ward / dept.

Signed & Dated: Signed & Dated:

Sign and date

Sign and date

Insert job title and print name Insert job title and print name

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The table below clarifies the ‘distribution of responsibilities’ and governance associated with acquiring a POCT device from Blood Sciences Dept.

TOPIC WWAARRDD//DDEEPPTT.. SSTTAAFFFF RREESSPPOONNSSIIBBIILLIITTIIEESS LLAABBOORRAATTOORRYY RREESSPPOONNSSIIBBIILLIITTIIEESS

Maintenance

Responsible for undertaking regular scheduled maintenance as per operations manual. Maintenance is vitally important to the correct functioning of the POCT devices; this includes keeping the equipment clean as per Infection Control policy. Equipment not kept clean will be reported to and removed by the Infection Prevention and Control team

Some devices may be maintained directly by laboratory staff. Correct maintenance protocol to be included in training packages. The laboratory must flag any issues regarding unclean devices to senior ward/dept. staff and any repeat offenders must be reported to Infection Control team due to the risk of dirty (e.g. blood-stained) equipment within a healthcare environment

Quality Control (QC)

Quality Control tests are essential to producing accurate and reliable results. The ward staff must follow the exact QC schedules accordingly and also when a new batch/Lot No. of consumables has been received and ready to be used. Repeating QC can be used to verify abnormal patient results and to ensure the device is working correctly

How and when to run a Quality Control test will be included in the training and information on how to acquire the QC solution will also be provided. If the QC solution is provided by the laboratory this will be routinely distributed to all wards/depts. The training should also ensure that each operator knows what to do in the event of a failed QC test

External Quality

Assurance (EQA)

EQA samples mmuusstt be analysed and the result returned to the laboratory as soon as possible. The envelope will be addressed to ‘Nurse in Charge’ – this is not to be left in an in-tray and should be actioned immediately. Any repeat incidences of not returning results could mean the device is removed from the clinical area

EQA to be sent from the laboratory at scheduled times throughout the year – results are to be compiled and published for ward/dept. staff to observe. The EQA results ensure the devices are working safely – if clinical areas are not returning results the laboratory must first warn them and potentially remove the device from use if repeated on the grounds of concern for patient safety

Training

Senior staff must ensure only appropriately trained operators use the devices. The swapping of staff badges to enable untrained staff to use the device is strictly prohibited and requires senior staff to enforce this. ‘Initial training’ in using a device must be via face-to-face training with cascade trainer or timetabled session. Staff will have to maintain their competencies every 2 years by undertaking ‘refresher training’; this can be via face-to-face training or alternatively via eLearning on ESR

Timetabled training sessions to be arranged via laboratory and published for all operators to see on POCT Intranet page. eLearning is provided for refresher training only (i.e. initial training for new starters/staff who have never used the device before must be face-to-face); Lab to ensure all staff know how to access eLearning course. Up-to-date training records to be maintained by the POCT manager and any queries regarding lack of access to the devices will be dealt with as soon as possible

Adherence to Trust Policies

Staff must adhere to POCT, Medical Devices, Infection Control, Cleaning/Disinfection and Incident reporting Trust Policies

Staff must adhere to POCT, Medical Devices, Infection Control, Cleaning/Disinfection and Incident reporting Trust Policies

Reporting Faulty Devices

Staff must report issues by completing the webpage form via intranet page ‘Log a fault with POCT device’. As per trust policy there is no out-of-hours support provided by the laboratory for troubleshooting POCT devices. Within core working hours the POCT manager may only provide advice/direction regarding how best to rectify the fault. Under no circumstances are staff to dispose of or replace equipment themselves

Once receiving a report of a faulty device; the POCT manager will do their upmost to reply as soon as reasonably possible. Providing information on how best to proceed e.g. contacting manufacturer to arrange an engineer visit, or sending the faulty equipment back to the lab to swap out for a new one… The solution varies on a case-by-case basis but the ultimate responsibility to resolve the issue lies with the ward/dept. that owns the device

Audit Staff must assist in Blood Sciences audits wherever possible The lab must undertake audits that highlight key processes in POCT and feedback

any findings to clinical areas who have taken part



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The Newcastle upon Tyne Hospitals NHS Foundation Trust

Equality Analysis Form A

This form must be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval.

PART 1

1. Assessment Date:

2. Name of policy / strategy / service:

Point-of-Care Testing Policy

3. Name and designation of Author:

Matthew Weir – Point of Care Testing Manager

4. Names & designations of those involved in the impact analysis screening process:

Matthew Weir – Point-of-Care Testing Manger and Lucy Hall - Equality and Diversity Lead

5. Is this a: Policy X Strategy Service

Is this: New X Revised

Who is affected Employees X Service Users X Wider Community

6. What are the main aims, objectives of the policy, strategy, or service and the intended outcomes? (These can be cut and pasted

from your policy)

The aim of this document is to provide guidance for safe and effective management and use of POCT systems that are fit for their intended purpose, used by a competent individual on the correct patient, giving quality results which become part of the patient’s record

7. Does this policy, strategy, or service have any equality implications? Yes No X

If No, state reasons and the information used to make this decision, please refer to paragraph 2.3 of the Equality Analysis Guidance before providing reasons:

01/12/2015

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8. Summary of evidence related to protected characteristics

Protected Characteristic

Evidence, i.e. What evidence do you have that the Trust is meeting the needs of people in various protected Groups

Does evidence/engagement highlight areas of direct or indirect discrimination? If yes describe steps to be taken to address (by whom, completion date and review date)

Does the evidence highlight any areas to advance opportunities or foster good relations. If yes what steps will be taken? (by whom, completion date and review date)

Race / Ethnic origin (including gypsies and travellers)

Interpreting Service Mandatory Equality & Diversity Training

Lack of interpreting support has been shown to impact on medication errors. Add ‘communication support’ to consent section of policy

No evidence to further advance or highlight new opportunities to foster good relations

other than the continued professional approach to Point-of-Care Testing improving

the patient experience

Sex (male/ female)

Mandatory Equality & Diversity Training No areas of direct or in-direct discrimination highlighted

Religion and Belief


Sexual orientation including lesbian, gay and bisexual people


Age Information on POCT devices available upon request to POCT manager; Trust policy on ‘Consent for Examination or Treatment (with reference to the Mental Capacity Act 2005)’ adhered to ‘You’re Welcome’ accreditation of Children and Young People’s services Dementia friendly training and environments

No areas of direct or in-direct discrimination highlighted

Disability – learning difficulties, physical disability, sensory impairment and mental health. Consider the needs of carers in this section

Interpreting Service

Mandatory Equality & Diversity Training

Learning Disability Liaison Nurse can support staff where patients with a learning disability are finding it difficult to understand investigations

Mental Capacity Act Training

Lack of interpreting support has been shown to impact on medication errors.

Add communication support to consent section of policy.

Self- management is an important part of empowering patients to manage long term conditions; Recognise this in the scope of the policy.

Gender Re-assignment


Marriage and Civil Partnership


Maternity / Pregnancy


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9. Are there any gaps in the evidence outlined above? If ‘yes’ how will these be rectified?

No gaps outlined

10. Engagement has taken place with people who have protected characteristics and will continue through the Equality

Delivery System and the Equality Diversity and Human Rights Group. Please note you may require further engagement in respect of any significant changes to policies, new developments and or changes to service delivery. In such circumstances please contact the Equality and Diversity Lead or the Involvement and Equalities Officer.

Do you require further engagement? Yes No X

11. Could the policy, strategy or service have a negative impact on human rights? (e.g. the right to respect for private and

family life, the right to a fair hearing and the right to education?

No negative impact on human rights

PART 2 Name:

Matthew Weir

Date of completion:

03/12/2018

(If any reader of this procedural document identifies a potential discriminatory impact that has not been identified, please refer to the Policy Author identified above, together with any suggestions for action required to avoid/reduce the impact.)

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