1. What’s 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. What’s the best quality program for your lab?
Why have a quality program?
Alternatives
Comparisons
Components of a quality system
Test validation
Discussion/Questions 2 2

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!! 3

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

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

6. 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) 6

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 7

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

9. Accreditation routes ISO 9001:2008 Quality Management Systems
registration, customer-focused
ISO/IEC General Requirements for the Competence of Testing and Calibration Laboratories
test-specific scope accreditation
AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory, v 4.3
incorporates ISO/IEC 17025/OIE standards
OECD Good Laboratory Practice (GLP) 9

10. 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 10

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

12. 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 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 12

13. 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 13

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 14

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

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. 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 17

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 18

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. 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! 20

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. 21

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 22

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 23

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 24

25. SOP analytical validation25

26. SOP diagnostic (field) validation26

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 27

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. 28

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