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Whats the best quality program for your lab? Grant Maxie, DVM, PhD, DACVP Director, Animal Health Laboratory; Co-Executive Director Nadine Ryan, BSc Quality.

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Presentation on theme: "Whats the best quality program for your lab? Grant Maxie, DVM, PhD, DACVP Director, Animal Health Laboratory; Co-Executive Director Nadine Ryan, BSc Quality."— Presentation transcript:

1 Whats the best quality program for your lab? Grant Maxie, DVM, PhD, DACVP Director, Animal Health Laboratory; Co-Executive Director Nadine Ryan, BSc Quality Manager, Laboratory Services Division, University of Guelph CAHLN-RCTLSA annual meeting, Calgary, AB June 8, 2010

2 2 22 Why have a quality program? Alternatives Comparisons Components of a quality system Test validation Discussion/Questions Whats the best quality program for your lab?

3 3 3 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 problems root cause analysis minimize re-work employee recruitment and retention business sustainability and continuity continuous improvement!!

4 4 4 Stakeholders/partners of the AHL: Livestock producers & animal owners Practitioners AHL CFIA WOAH (OIE) Public health University Provincial agriculture ministry Industry 4

5 5 5 AHL function and structure Client service Laboratory testing Quality program 5

6 6 6 What client services do AHLs 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)

7 7 7 Quality system support of client service Vision Mission statement Values Quality goals and objectives Quality manual – procedures Requires: Periodic strategic planning Management and staff involvement and commitment

8 8 8 Overarching quality principles say what you do do what you say prove it improve upon it

9 9 9 Accreditation routes 1. ISO 9001:2008 Q uality Management Systems registration, customer-focused 2. ISO/IEC 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)

10 10 1. ISO 9001:2008 registration focuses on customer satisfaction and managing the organizations interconnected processes to meet the customers 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

11 11 Why ISO 9001 for a lab? 11 Continuous improvement cycle – plan, do, check, act For a laboratory – substitute service for product

12 12 2. ISO/IEC accreditation expands upon the ISO 9001 generic requirements, rewriting to specific laboratory requirements and adding technical requirements relevant to the laboratorys competence to produce accurate and reliable results federal labs (CFIA, USDA) typically operate under an ISO/IEC 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

13 13 Why ISO/IEC for vet dx lab ? Internationally recognized Global acceptance of laboratory data Canadas 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 13

14 14 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 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

15 15 _ISO_17025_Accreditation_Programs_AC_102_4_3_v_1___2_.pdf AAVLD website - Member side - - Accreditation files

16 16 4. Other accreditation options? OECD GLP additional quality documentation required contract research lab (CRO) specialty ISO/IEC flexible scope (tentative) include multiple test/test types within a broader scope, e.g., veterinary microbiology USA - A2LA (American Association for Laboratory Accreditation) Veterinary Laboratory Accreditation Program

17 17 Components of a quality program ISO section 4 – Management requirements 4.1 organization and management – authorities 4.2 quality system – quality policy and objectives documented in a quality manual 4.3 document control 4.4 review of requests, tenders, contracts 4.5 subcontracting of test services 4.6 purchasing of services and supplies 4.7 complaints 4.8 control of nonconforming testing and test results 4.9 corrective and preventive actions 4.10 records management 4.11 internal audits 4.12 periodic management reviews

18 18 Components of a quality program ISO section 5 – Technical requirements 5.1 general 5.2 personnel (competence, training) 5.3 accommodation and environmental conditions 5.4 test methods and method validation SOPs, documented proficiency 5.5 equipment – maintenance, calibration 5.6 measurement traceability – reference materials 5.7 specimens - sampling 5.8 handling of specimens 5.9 ensuring the quality of test results - QC 5.10 reporting of test results

19 19 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

20 20 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!

21 21 What is a valid test? an assay that reliably produces correct results e.g., correctly identifies animals as positive or negative for an analyte, antibody, nucleic acid, antigen, etc.

22 22 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

23 23 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

24 24 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

25 25 SOP analytical validation

26 26 SOP diagnostic (field) validation

27 27 References & resources on how to validate tests OIE Manual of Standards traditional PCR 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

28 28 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.

29 29

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