Demonstrating Data and Test Result Validity for Diagnostic Aquatic Animal Health Laboratories

• Published in: Journal of aquatic animal health Vol. 15; no. 4; pp. 287 - 294
• Main Authors: Wiegers, Ann L., Heidel, Jerry R., Scarfe, A. David
• Format: Journal Article
• Language: English
• Published: Taylor & Francis Group 01-12-2003
• ISSN: 0899-7659; 1548-8667
• DOI: 10.1577/H03-031.1

The information in this article is aimed towards the managers in laboratories that conduct testing in support of aquatic animal disease diagnosis or the determination of health status. This includes laboratories that do regulatory work—directly or indirectly—those who do testing for trade, and those who will be required to respond swiftly and effectively in the case of a national animal health emergency. The ability to demonstrate validity is essential for national security, protection of public and animal health, minimization of liability, and support of business and trade. Veterinarians, wildlife specialists, and aquatic animal health specialists may also find it valuable, as many points are directly pertinent to the establishment of a quality program in a clinical or individual practice laboratory. Data and test result validity are critical to timely and accurate diagnosis and treatment, effective disease and health management, reliable surveillance, and quick, appropriate responses in the event of an animal health emergency. There are currently four general areas of importance regarding the demonstration of data and test result validity: The conduct of testing; the use of valid, approved test methods; proficiency testing; and the use of reference materials. Demonstration of validity is achieved via the implementation and use of appropriate and documented technical, operational, and managerial policies, systems, procedures, and specifications that are scientifically sound, that meet the requirements of relevant third‐party consensus standards, and that can be verified by recognized, third‐party accreditation. The basis for the requirements of laboratory accreditation and accreditation body recognition programs in the United States and internationally that address these areas of analytical endeavor is discussed. Recent legislation and activities in establishing a unified national system of accreditation that meets applicable international standards may assist in creating national laboratory systems capable of effectively addressing data and test result validity and credibility in critical diagnostic areas.