Aquatic Diagnostic Laboratory

Quality Assurance

David B. Groman

Aquatic Diagnostic Services

Atlantic Veterinary College

Univerity of Prince Edward Island

Canada

Are Quality Programs

Necessary ?

Between 2010 and 2012, Oceana took

1,215 seafood samples from 674 retail

outlets in 21 states. When they tested

the DNA, they found that 33 percent were

mislabeled.

Newfoundland and Labrador's largest health

authority has apologized after nine breast

cancer patients were given the wrong results

and credits its new quality assurance

program for quickly detecting the mistakes.

Why do Diagnostic Labs Need

Q A Programs

A laboratory QA program has one

objective:

To provide confidence to clients in the

validity of the labs Test results and

services offered

A laboratory QA program has one

objective:

To provide confidence to clients in the

validity of the labs Test results and

services offered

The specific components of a quality

program or system will vary between

laboratories , depending upon the

complexity and extents of the testing

that is conducted

What is a Quality Program

Provides consistent monitoring and

evaluation of the performance in the

laboratory

Allows for the implementation and

follow-up or corrective actions for

non-conformance to proceedures

A Quality System

Examples of Aquatic QA Disasters

1970’s Gyrodacylus salaris in Norway

1970’s Cataracts in Salmon due to Low Zn

1980’s Furuculosis Outbreak in Norway

1990’s ISA Outbreak in NB Canada

2007 ISA Outbreak in Chile

QA Programs

College of American Pathologist

American Ass. of VeterianryDiagnostic Laboratories

Intenational OrganizationFor Standarization

Mexico Currently has at least 12 CAP

certified labs: ( for example )

Diagen SC Diagen

Laboratory Mexico DF

Grupo Diagnostico Medico PROA SA de CV

Carpermor West Laboratory, Guadalajara JA

Carpermor Laboratory, Mexico DF

Laboratorio Medico Polanco

Mexico DF

The Diagnostic Dilemma ?

Lab-A

BA 22C

Bio-Chem

Lab-B

TSA 22C

Lab C

BA 22+15C

Mass-Spec

Myocarditis

Nocardia sp.

No growth

Mycobacteria chelonae

Proficiency Testing for

Aquatic Veterinary

Diagnostic Laboratories

USDA – National Vet Service

Laboratory

EURL – Fish Diseases

UK Animal & Plant Health

Agency (APHA)

NACA – Proficiency TestingProgram

2001 Diagnostic labs needed some QA

2007 ISA Outbreak increase in QA for

Aquatic Diagnostic Labs

2010 Regulations were enforced with

proficiency testing and ISO-17025

protocols for all labs

Ring Tests: ISAV, SAV, IPNV and PCR

CHILE

Veterinary Laboratory Association

Quality Assurance Program®

V. L. A.

Quality Assurance Program

( VLA-QAP )

Veterinary Laboratory Assocociation ( VLA )

BioMedicaDiagnostics Inc.

Atlantic VeterinaryCollege ( AVC)

Veterinary Laboratory Association

International veterinary organization for diagnostic

laboratories

Formed in 1989 by 5 people

Organizational Goal – To provide consistency

throughout veterinary diagnostic laboratories

Established Proficiency Program

More info: www.vetlabassoc.com

VLA Proficiency Program

1989 Program administered by VLA

membership with 23 labs in Chemistry

& Hematology

1990 Endocrinology and Serology

1991 Bacteriology

1992 Parasitology

1997 Program administered by VLA & AVC

VLA Quality Assurance Program®

1997 Histopathology and Therapeutic Drug

Monitoring

2003 Urinalysis

2012 Aquatic & Terrestrial Virtual Microscopy

2016 Aquatic Bacteriology ( NEW )

Today - Over 300 participants world-wide and

growing

Primary Purpose of VLA Quality

Assurance Program®

Provide a confidential tool which

enables laboratory personnel to

compare their test results to those

obtained in other laboratories testing

the same materials.

External quality control program

Specific for veterinary laboratories

Including multiple species

International Client Base

WORLD-WIDE DISTRIBUTION

Canada 11%

USA 76%

New Zealand 2%Germany 1%

Other 1%South Africa 1%United Kingdom

1%

West Indies 1%Austria 1%

Australia 5%

Currently 310 labs worldwide

205 USA, 30 Canada, 75 International

No clients in Mexico

Clients in Barbados, Trinidad -Tobago,

and Saint Kitts - Nevis.

Types of Laboratories (%)

0

10

20

30

40

50

60

70

80

90

100

LAB TYPES

Commercial

University

Government

Private

Vet clinic

Research facility

Human hospital

Module Participation (%)

0

10

20

30

40

50

60

70

80

MODULE

BACT

CHEM-1

CHEM-2

ENDO

HEM-1

HEM-2

HISTO

PARAS

SERO

TDM

URINE

How the Program Works:

Samples sent either 2 or 4 times / yr

Samples run in the labs;

Results or run within 10 days and now reported via website entry

Data entered at Program Centre

Reports of results generated then returned to Participants via Website

Benefits of Participating in the

VLA Quality Assurance Program®

I. Reinforce the internal confidence in your lab,

your results, and your service to clients

Monitor quality of its testing procedures

II. Identify and correct problems

Ensure results are not only precise, but

accurate

III. Continuing education tool

IV. Technical / Professional support

I. VLA-QAP List Server

II. Call AVC Tech Support :

III. 1-800-325-2436

V. Marketing tool for clients

2016 – VLA-QAP Deliverables

Technology Innovation

New Aquatic Bacteriology Module

Accreditation ( ISO 17043 )

Certified as a Proficiency Test Provider

What is virtual microscopy?

What is virtual microscopy ?

Questions ?

Atlantic Bluefin Tuna

http://vla.timelessveteri

narysystems.com/

Quality assurance caught errors quickly,

Eastern Health says