Changing culture: Perspectives on transforming clinical microbiological practice

Dr Valerie BevanHead of Department for Evaluations, Standards and Trainingvalerie.bevan@hpa.org.uk www.evaluations-standards.org.uk

Celebrating 25 years of the BSMT14 May 2010

Structure of talk Influencing factors

Health and safety Quality Methods Technology Other influences

Political Financial Education & training Science Professional Customer Cultural Equality and diversity (race, disability, gender, age, sexual orientation, religion and belief)

Health and safety 1957 lab workers 2-9 times more likely to die of TB than others1969-70 Edinburgh - hepatitis outbreak (8 pts; 3 staff died)1973 London School of Hygiene - Smallpox escape Perceptions of risk

Health and SafetyHealth and Safety at Work etc Act 1974Howie Report 1978, 1983 (JW Howie and CH Collins)Report of the Working Party to Formulate a Code of Practice for the Prevention of Infection in Clinical Laboratories (the "Howie Report")The Howie Code (1978)Code of Practice for the Prevention of Infection in Clinical Laboratories and Post-mortem Rooms (the Howie Code")

Howie ReportAlthough an early draft had been "leaked and was published in a trades union journal the Report has not been published by the Department.

The reasons for this were never made clear to members of the Working Party which produced it, nor to the newspapers which supported publication.

It may be relevant here to note that only one of the five recommendations made in the Report (testing of equipment by the PHLS) has been implemented.

For details see Howie and Collins The Code of Practice

H&S LegislationHealth and Safety (Dangerous Pathogens) Regulations 1981 Control of Substances Hazardous to Health Regulations 1988 (COSHH) (EC Directive 80/1107/EEC)Amended 1996, 1887, 1998, 2001Replaced by 2002 COSHH Regulations (EC Directive 98/24/EC) (amended 2003, 2004)

H&SAdvisory Committee on Dangerous Pathogens (ACDP) "Categorisation of biological agents according to hazard and categories of containment" 4th ed, 1995ACDP "The management, design and operation of microbiological containment laboratories" published 2001Health Services Advisory Committee (HSAC) guidance, "Safe working and the prevention of infection in clinical laboratories and similar facilities" (updated in 2003)ACDP 2005 "Biological agents: managing the risks in laboratories and healthcare premises"

Is it true that more Americans who were in the Twin Towers have died in car crashes since 9/11/2001 than died in the 9/11 atrocity?

Car crashes kill 400 times more people than international terrorism does in developed countries

History of QualityGuilds system (12th-19th Century - master craftsmen, journeymen)Industrial revolution (18th-19th Century, mass production)Rise of technology (tools, machines, factories, iron prod)Mass production (Ford cars)1st World War (munitions)Need for inspectionTechnical Inspection Association (1919)Walter Shewart (QC stats 1920s)

History of QualityPost WW2 quality (Japan, Toyota)1980s (quality revolution in US)1990s (service industries, JIT, TQM, Six Sigma, ZDP, Benchmarking, LEAN etc)1970 external quality assessment (40th anniversaries)Late 1980s (CPA-UK) lab accreditation ISO 9001:2000 Quality Management SystemISO 13485:2003 QMS for Medical Devices

QualityIVD Directive 98/79/EC on in vitro Diagnostic Medical Devices2002 UK - Medical Devices Regulations consumer protection2008-9 (CPA-UKAS) ISO 15189:2003 International standards for medical laboratoriesEC Medical Devices Directives Guidance Notes on in vitro Diagnostic medical devices 98/79/EC (The CE Marking)NICEEBM

What do we mean by Quality?The degree to which a set of inherent characteristics fulfils requirementsISO 9000

What do we mean by Quality?What do you look for in a car?Point A to point B? Speed?Colour?Manual vs Automatic?Diesel vs Petrol?Good stereo?Practicality vs styling?

What do we mean by Quality?In technical usage, quality can have two meanings:

the characteristics of a product or service that bear on its ability to satisfy stated or implied needs a product or service free of deficiencies

Source: American Society for Quality http://www.asq.org/glossary/q.html A subjective term for which each person has his or her own definition

Quality in the laboratoryThe right result on the right specimen from the right patient that is accurate, timely, and properly interpreted

Prism HIV Ag/Ab ComboMurex HIV AgAb Combination Earliest HIV Detection Earliest anti-HIV Detection5101520025= Combined Ag/Ab assay;= immunometric assay;= Class specific antibody capture assay;= antiglobulin assay.Murex HIV 1.2.0Ortho Ab Capt. ELISAVironostika HIV Uni-Form II plus OIMx HIV1/2 III plusAxSYM HIV 1/2 gO Clonesystems Detect HIV v1Biotest HIV 1/2 recombinantGenscreen ULTRA HIV Ag-AbArchitect HIV Ag/Ab comboRoche combi HIVVironostika Ag/Ab update Enzygnost HIV1/2 plusInnotestHIV1/2AxSYM HIV Ag/Ab ComboBiotest Anti-HIV Tetra ELISA

Quality AssurancePatient[Seth J. Quality Assurance. In: CP Price, DJ Newham (eds) Principles and Practice of Immunoassay. 2nd ed. London. pp 211-228]

What do we mean by Quality Management?

Quality manual Meeting accreditation standards Adequate quality assurance (EQA, IQC, IQA) Validated methods, equipment & kits Having good SOPsQuality Management System (QMS)

What do we mean by assuring quality?

Having a service culture focussed on the user / clinician and patient Timely, high quality clinical advice and interpretation of results Good reporting of all diseases for surveillance Public health focus

Quality Accounts DH expectationsQuality Accounts should assume the same significance for NHS as financial accountsFor the first time, all organisations will account publicly for the quality of care they provideThe first Quality Accounts will (subject to legislation) be published in 2010, based on information about quality improvement in 2009/10Measures therefore need to be identified and in place prior to April 2009

Quality AssurancePatient[Seth J. Quality Assurance. In: CP Price, DJ Newham (eds) Principles and Practice of Immunoassay. 2nd ed. London. pp 211-228]

Need for standardised methods 2002Need forco-ordinated system for evaluation managed intro of new technologyBackground

Clinical Guidance Notes (QSOP)

Background~Over 200 National Standard Methods 84 Clinical bacteriologyBSOPs37BSOPIDs/BSOPTPs 47 41 Virology / serology algorithms and SOPs 40 Food, water and environmental 39 Guidance Notes 2 Syndromic algorithms (+3 in development)

All day meetings every 2 months Working Groups Virology Bacteriology Syndromic Algorithms Molecular Technology (being formed) Food, Water and Dairy Group membership Chair Head of Standards Unit Two staff write, co-ordinate process Medical, clinical and biomedical scientists Stakeholders (AMM, CVN, ACM, IBMS, SGM, UK wide, Wales, Scotland, N Ireland other networks)National Standard Method Working Groups

ExperimentalevidenceScientific literatureDocuments are based on:

Final versions in Adobe .pdf format Access to drafts and reviews (in MS Word) requires password Over 1500 passwords in 75 countries to access our website for NSMswww.hpa-standardmethods.org.ukwww.evaluations-standards.org.uk www.hpa.org.ukAccess

Bench level guideFront endLink bacteriology and virology testingMake informed decisionsSelection of testsAppropriate samplesAppropriate reportingCross referencing to relevant NSMsSyndromic algorithms

Hepatitis in Neonates Syndromic algorithms

a Clinical history / Patient group

Sample type

Initial testing

Supplementary testing

Fulminant

Serum / Blood

HAV: anti-HAV IgM(VSOP 27)

HEV:anti-HEV IgM (VSOP 6)

HBV: HBsAg, anti-HBC IgM(VSOP 4)

d Blood cultures(BSOP 37)

c Immuno-compromised

Serum or EDTA / Urine

CMV (Quantification)(VSOP 35)

HAV: anti-HAV IgM(VSOP 27)

HBV; HBsAg(VSOP 4)

HCV: HCV rt PCR (VSOP 5)

Adenovirus

EBV(VSOP 26)

HHSV 6(VSOP 23)

Aspergillosis

Candida

Glandular fever type symptoms(QSOP 44)

Serum

EBV: EBV specific serology or heterophile antibody test(VSOP 26)

CMV: CMV IgM(VSOP 28)

HIV: HIV antibody(VSOP 11)

T. palladium(VSOP 44)

Toxoplasma gondii

HHSV 6(VSOP 23)

= PCR

= Serology

= Isolation

Molecular VirologyAccelerating progress to molecular methodologiesQuantitative PCRHIV, HCV, HBV, CMV, EBV SARS, influenza A H5N1, influenza A & B

Replacement of previous methodologyChlamydia EIA - withdrawal of VSOP 1Technology change withdrawal of VSOP 19Tissue cultureconversion to PCR -respiratory viruses, herpesviruses, enteroviruses

Consensus / wide literature review Help you with accreditation Wide consultation Professionally led / hosted by HPA Supported by NHS, professional and management organisations / experts / Links with MHRA, VLA, CVN, all microbiology, public health / epidemiologists Honest broker Involvement of key people eg eminent Medical Editors, experts on Bacteriology, Virology, Food/Water, TB, Parasites, Mycology Free! (ASM Cumitech online $249.95 / annual renewal $99.95)Why use NSMs?

How can you become a password holderTwo main routes:Fill in the form at the front of the roomE-mail standards@hpa.org.ukGet involved in the process become a password holder!

AcknowledgementsThanks to all staff in Department for Evaluations Standards and Training

Ruhi Siddiqui, Head of Standards UnitIan Sharp, Head of Quality Systems UnitSatnam Sagoo, Head of Education and Training UnitKeith Perry, seconded to Department of HealthJoe Vincini, National Reference Laboratory, Melbourne

Dr Ken Mutton, Chair of the Virology Working GroupJon White, Head of Medical Illustration andDr Rob George (sorry about the photo)

David Naylor for history of quality

www.hpa.org.ukwww.evaluations-standards.org.uk www.bsmt.org.uk

*As for microbiology laboratories, they are under a variety of management arrangements and follow no standard diagnostic criteria in their operations. There is a need to bring consistency to the delivery of public health functions of laboratories and standardise on current good practicesAction proposed: rationalisation of microbiology laboratories and introduction of standards for diagnosis and profiling of micro-organisms

First SOP issued in 1996Real need for increased representation from individuals with molecular expertise