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What’s the best quality program for your lab?

Grant Maxie, DVM, PhD, DACVPDirector, Animal Health Laboratory; Co-Executive Director

Nadine Ryan, BScQuality Manager, Laboratory Services Division, University of Guelph

CAHLN-RCTLSA annual meeting, Calgary, AB June 8, 2010

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• Why have a quality program?

• Alternatives

• Comparisons

• Components of a quality system

• Test validation

• Discussion/Questions

What’s the best quality program for your lab?

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Why have a quality program?

meet the expectations of clients especially if a requirement of contracts

ensure credibility of results – locally, nationally, and internationally

deal with complaints and solve problemsroot cause analysis

minimize re-work employee recruitment and retention business sustainability and continuity continuous improvement!!

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Stakeholders/partners of the AHL:

Livestock producers

& animal owners

Practitioners

AHL

CFIA

WOAH (OIE) Public

healthUniversity

Provincial agriculture ministry

Industry

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AHL function and structure

Client service

Laboratory testing

Quality program

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What client services do AHL’s provide?

timely, accurate diagnostic testing credible consultative services support for teaching and research activities strongly client-focused data for risk management - wellness, on-farm food safety, quality assurance animal health surveillance data - public health link (CAHSN – CNPHI)

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Quality system support of client service

Vision Mission statement Values Quality goals and objectives Quality manual – proceduresRequires:

Periodic strategic planning Management and staff involvement and

commitment

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Overarching quality principles

say what you do do what you say prove it improve upon it

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Accreditation routes

1. ISO 9001:2008 Quality Management Systems registration, customer-focused

2. ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories test-specific scope accreditation

3. AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory, v 4.3 incorporates ISO/IEC 17025/OIE standards

4. OECD Good Laboratory Practice (GLP)

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1. ISO 9001:2008 registration

focuses on customer satisfaction and managing the organization’s interconnected processes to meet the customer’s and regulatory requirements

includes management responsibility, resource management, product (service) realization, and measurement, analysis and improvement

the requirements of ISO 9001 are generic and apply to all organizations

involves annual surveillance audits and a registration audit every 3 years

general in scope, and does not involve assessment of competence to perform individual tests

Cost = ~$5,000 + expenses / year

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Why ISO 9001 for a lab?

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Continuous improvement cycle – plan, do, check, actFor a laboratory – substitute “service” for “product”

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2. ISO/IEC 17025 accreditation

expands upon the ISO 9001 generic requirements, rewriting to specific laboratory requirements and adding technical requirements relevant to the laboratory’s competence to produce accurate and reliable results

federal labs (CFIA, USDA) typically operate under an ISO/IEC 17025 standard, and work subcontracted from them must meet this standard

biennial external audits are required, questionnaire in intervening years

accreditation is scope-specific (limited to audited tests) and posted on the website of the national accrediting body, e.g., Standards Council of Canada (SCC)

Cost = ~ $6,000 - $29,000 + expenses / year depending on # of tests

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Why ISO/IEC 17025 for vet dx lab? Internationally recognized Global acceptance of laboratory

data Canada’s accreditation bodies

(SCC & CALA) are members of the International Laboratory Accreditation Cooperation (ILAC) and evaluated by other members

The ILAC network consists of 135 bodies representing 88 different economies

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3. AAVLD accreditation

publically supported veterinary diagnostic labs only has evolved from a peer-help process now based on the OIE Quality Standard and Guidelines

for Veterinary Laboratories: Infectious Diseases, 2008, which is consistent with the ISO/IEC 17025 standard

external audits vary, with a maximum of 5 years between audits

42 accredited labs in North America – BC and ON in Canada

annual fee of $500, audit year = $1,000 + $500/branch lab + local expenses

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http://data.memberclicks.com/site/aavld/Comparison_of_AAVLD_-_ISO_17025_Accreditation_Programs_AC_102_4_3_v_1___2_.pdf

AAVLD website

- Member side

- - Accreditation files

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4. Other accreditation options?

OECD GLP additional quality documentation required contract research lab (CRO) specialty

ISO/IEC 17025 flexible scope (tentative) include multiple test/test types within a broader

scope, e.g., “veterinary microbiology” USA - A2LA (American Association for

Laboratory Accreditation) http://www.a2la.org/ Veterinary Laboratory Accreditation Program

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Components of a quality program

ISO section 4 – Management requirements4.1 organization and management – authorities4.2 quality system – quality policy and objectives

documented in a quality manual

4.3 document control4.4 review of requests, tenders, contracts4.5 subcontracting of test services4.6 purchasing of services and supplies4.7 complaints4.8 control of nonconforming testing and test results4.9 corrective and preventive actions4.10 records management4.11 internal audits4.12 periodic management reviews

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Components of a quality program

ISO section 5 – Technical requirements5.1 general5.2 personnel (competence, training)5.3 accommodation and environmental conditions5.4 test methods and method validation

SOPs, documented proficiency

5.5 equipment – maintenance, calibration5.6 measurement traceability – reference materials5.7 specimens - sampling5.8 handling of specimens5.9 ensuring the quality of test results - QC5.10 reporting of test results

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Challenges in maintaining any Q program

staying current – annual/biennial review/ updating of all materials

internal auditing – how frequent, followup on CAPAs

trend analysis – QC on tests, trends in nonconformances

staff commitment – cost-benefit analysis measurable objectives

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Why validate tests?

implications for patients (individuals or groups), need to support evidence-based medicine

within lab confidence in test accuracy & precision understand biases (false positives, negatives) competent client service

DVMs are more sophisticated contract/industry requirement

maintain lab revenue!

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What is a valid test?

an assay that reliably produces correct resultse.g., correctly identifies animals as positive or

negative for an analyte, antibody, nucleic acid, antigen, etc.

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Challenges to validation

information is sometimes available publications package inserts

pressure to release new tests resources, i.e., $$ & time logistical issues

availability of samples from target & control populations numbers collection

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AHL test validation process

feasibility diagnostician determines the need for a new

test new technologies (molecular biology) industry needs economic

‘old’ tests are not included discuss amongst selected users in lab

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Diagnostic validation considerations

how will the test be used target population & reference population sample size

a priori estimate of Se, Sp statistical confidence

sampling random, convenience, etc. inclusion/exclusion

bias reduction (blind evaluation) gold standard

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SOP analytical validation

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SOP diagnostic (field) validation

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References & resources on how to validate tests OIE Manual of Standards

traditionalhttp://www.oie.int/norms/mmanual/A_00012.html

PCR http://www.oie.int/norms/mmanual/A_00014.html

Veterinary Epidemiology Textbooks Preventive Veterinary Medicine, 2000,

Volume 45, Special Issue: Validation and application of diagnostic tests used in veterinary

epidemiologic studies AAVLD Workshop on Test Validation AAVLD Epidemiology Committee

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Summary

The bottom line of an effective and auditable laboratory quality program is client satisfaction through rigorous monitoring of valid tests and continuous improvement of processes.

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