Changing culture perspectives on transforming clinical microbiological practice
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Changing culture: Perspectives on transforming clinical microbiological practice. Dr Valerie Bevan Head of Department for Evaluations, Standards and Training [email protected] www.evaluations-standards.org.uk. Celebrating 25 years of the BSMT 14 May 2010. Influencing factors

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Changing culture perspectives on transforming clinical microbiological practice

Changing culture: Perspectives on transforming clinical microbiological practice

Dr Valerie Bevan

Head of Department for Evaluations, Standards and Training

[email protected]

www.evaluations-standards.org.uk

Celebrating 25 years of the BSMT

14 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)

Structure of talk


Health and safety

Health and safety

  • 1957 lab workers 2-9 times more likely to die of TB than others

  • 1969-70 Edinburgh - hepatitis outbreak (8 pts; 3 staff died)

  • 1973 London School of Hygiene - Smallpox escape

  • Perceptions of risk


Health and safety1

Health and Safety

  • Health and Safety at Work etc Act 1974

  • Howie 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 report

Howie Report

  • Although 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 legislation

H&S Legislation

  • Health and Safety (Dangerous Pathogens) Regulations 1981

  • Control of Substances Hazardous to Health Regulations 1988 (COSHH) (EC Directive 80/1107/EEC)

  • Amended 1996, 1887, 1998, 2001

  • Replaced by 2002 COSHH Regulations (EC Directive 98/24/EC) (amended 2003, 2004)


Changing culture perspectives on transforming clinical microbiological practice

H&S

  • Advisory Committee on Dangerous Pathogens (ACDP) "Categorisation of biological agents according to hazard and categories of containment" 4th ed, 1995

  • ACDP "The management, design and operation of microbiological containment laboratories" published 2001

  • Health 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"


Changing culture perspectives on transforming clinical microbiological practice

  • 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 quality

History of Quality

  • Guilds 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 inspection

  • Technical Inspection Association (1919)

  • Walter Shewart (QC stats 1920s)


History of quality1

History of Quality

  • Post 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 System

  • ISO 13485:2003 – QMS for Medical Devices


Quality

Quality

  • IVD Directive 98/79/EC on in vitro Diagnostic Medical Devices

  • 2002 UK - Medical Devices Regulations – consumer protection

  • 2008-9 (CPA-UKAS)

  • ISO 15189:2003 – International standards for medical laboratories

  • EC Medical Devices Directives – Guidance Notes on in vitro Diagnostic medical devices 98/79/EC (The CE Marking)

  • NICE

  • EBM


What do we mean by quality

What do we mean by “Quality”?

  • “The degree to which a set of inherent characteristics fulfils requirements”

  • ISO 9000


What do we mean by quality1

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 quality2

What do we mean by ‘Quality’?

A subjective term for which each person has his or her own definition

  • 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


Quality in the laboratory

Quality in the laboratory

  • The right result on the right specimen from the right patient that is accurate, timely, and properly interpreted


Changing culture perspectives on transforming clinical microbiological practice

Vironostika Ag/Ab

Vitros ECi

anti-HIV 1+2

Genscreen PLUS

HIV AgAb

Genscreen HIV

Version 2

Detect-HIV

v.4

Access HIV 1/2 New

Vidas DUO

Enzygnost HIV Integral

Genscreen ULTRA

HIV Ag-Ab

Ortho Ab Capt.

ELISA

AxSYM HIV

Ag/Ab Combo

Vironostika Ag/Ab

update

Clonesystems

Detect HIV v1

Architect HIV Ag/Ab combo

Vironostika HIV

Uni-Form II plus O

Roche combi HIV

Murex

HIV 1.2.0

Enzygnost

HIV1/2 plus

0

5

10

15

20

25

Earliest anti-HIV Detection

Earliest HIV Detection

AxSYM HIV

1/2 gO

Innotest

HIV1/2

Murex HIV AgAb

Combination

IMx HIV1/2 III plus

Biotest Anti-HIV

Tetra ELISA

Biotest HIV 1/2

recombinant

Prism HIV

Ag/Ab Combo

= Combined Ag/Ab assay;

= antiglobulin assay.

= immunometric assay;

= Class specific antibody capture assay;


Quality assurance

Test selection

Patient preparation

Specimen Selection

Specimen collection

Specimen preservation

Specimen reception

Results dispatched

Unique lab identifier

Laboratory

Results interpreted

Analysis

SOPs

EQA

IQA

QA

IQC

Analytical validation

Clinical management

Clinical validation

Reporting and Interpretation

Patient

Quality Assurance

[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

What do we mean by Quality Management?

Quality Management System (QMS)

  • Quality manual

  • Meeting accreditation standards

  • Adequate quality assurance (EQA, IQC, IQA)

  • Validated methods, equipment & kits

  • Having good SOPs


What do we mean by assuring quality

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 expectations

Quality Accounts DH expectations

  • Quality Accounts should assume the same significance for NHS as financial accounts

  • For the first time, all organisations will account publicly for the quality of care they provide

  • The first Quality Accounts will (subject to legislation) be published in 2010, based on information about quality improvement in 2009/10

  • Measures therefore need to be identified and in place prior to April 2009


Quality assurance1

Test selection

Patient preparation

Specimen Selection

Specimen collection

Specimen preservation

Specimen reception

Results dispatched

Unique lab identifier

Laboratory

Results interpreted

Analysis

SOPs

EQA

IQA

QA

IQC

Analytical validation

Clinical management

Clinical validation

Reporting and Interpretation

Patient

Quality Assurance

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


Changing culture perspectives on transforming clinical microbiological practice

Background

2002

Need for standardised methods

  • Need for

  • co-ordinated system for evaluation

  • managed intro of new technology


Changing culture perspectives on transforming clinical microbiological practice

INVESTIGATION OF FAECES SPECIMENS FOR BACTERIAL PATHOGENS

BSOP 30


Clinical guidance notes qsop

Clinical Guidance Notes (QSOP)


Changing culture perspectives on transforming clinical microbiological practice

Background

~Over 200 National Standard Methods

  • 84 Clinical bacteriology

  • BSOPs37

    • BSOPIDs/BSOPTPs 47

  • 41 Virology / serology algorithms and SOPs

  • 40 Food, water and environmental

  • 39 Guidance Notes

  • 2 Syndromic algorithms (+3 in development)


Changing culture perspectives on transforming clinical microbiological practice

National Working

Groups

National Standard Method Working Groups

  • All day meetings every 2 monthsWorking 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)


Changing culture perspectives on transforming clinical microbiological practice

Documents are based on:

Experimental

evidence

Scientific

literature


Changing culture perspectives on transforming clinical microbiological practice

Access

www.hpa-standardmethods.org.uk

www.evaluations-standards.org.uk

www.hpa.org.uk

  • 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 NSMs


Changing culture perspectives on transforming clinical microbiological practice

Syndromic algorithms

  • Bench level guide

  • ‘Front end’

  • Link bacteriology and virology testing

  • Make informed decisions

  • Selection of tests

  • Appropriate samples

  • Appropriate reporting

  • Cross referencing to relevant NSMs


Changing culture perspectives on transforming clinical microbiological practice

Syndromic algorithms

Hepatitis in Neonates


Molecular virology

Molecular Virology

  • Accelerating progress to molecular methodologies

  • Quantitative PCR

  • HIV, HCV, HBV, CMV, EBV

  • SARS, influenza A H5N1, influenza A & B

  • Replacement of previous methodology

  • Chlamydia EIA - withdrawal of VSOP 1

  • Technology change – withdrawal of VSOP 19

  • Tissue culture

  • conversion to PCR -

  • respiratory viruses, herpesviruses, enteroviruses


Changing culture perspectives on transforming clinical microbiological practice

Why use NSMs?

  • 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)


How can you become a password holder

How can you become a password holder

  • Two main routes:

  • Fill in the form at the front of the room

  • E-mail [email protected]

  • Get involved in the process become a password holder!


Acknowledgements

Acknowledgements

  • Thanks to all staff in Department for Evaluations Standards and Training

  • Ruhi Siddiqui, Head of Standards Unit

  • Ian Sharp, Head of Quality Systems Unit

  • Satnam Sagoo, Head of Education and Training Unit

  • Keith Perry, seconded to Department of Health

  • Joe Vincini, National Reference Laboratory, Melbourne

  • Dr Ken Mutton, Chair of the Virology Working Group

  • Jon White, Head of Medical Illustration

  • and

  • Dr Rob George (sorry about the photo)

  • David Naylor for history of quality

  • www.hpa.org.uk

  • www.evaluations-standards.org.uk

  • www.bsmt.org.uk


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