Code of Federal Regulations Title 9. Animals and Animal Products § 9.54.11 Approval of laboratories to run official scrapie tests and official genotype tests

(1) Employs personnel assigned to supervise and conduct the testing who are qualified to conduct the test based on education, training, and experience and who have been trained by the National Veterinary Services Laboratories (NVSL) or who have completed equivalent training approved by NVSL;

(2) Has adequate facilities and equipment to conduct the test;

(3) Follows standard test protocols that are approved or provided by NVSL;

(4) Meets check test proficiency requirements and consistently produces accurate test results as determined by NVSL review;

(5) Meets recordkeeping requirements;

(6) Will retain records, slides, blocks, and other specimens from all cases for at least 1 year and from positive cases and DNA from all genotype tests for at least 5 years and will forward copies of records and any of these materials to NVSL within 5 business days of request;  Except that, NVSL may authorize a shorter retention time in a standard operating procedure or contract;

(7) Will allow APHIS to inspect the laboratory without notice during normal business hours. An inspection may include, but is not limited to, review and copying of records, examination of slides, review of quality control procedures, observation of sample handling/tracking procedures, observation of the test being conducted, and interviewing of personnel;

(8) Will report all test results to State and Federal animal health officials and record them in the National Scrapie Database within timeframes and in the manner and format specified by the Administrator;  and

(9) Complies with any other written guidance provided to the laboratory by the Administrator.