9 CFR 147.52 - Authorized laboratories.
These minimum requirements are intended to be the basis on which an authorized laboratory of the Plan can be evaluated to ensure that official Plan assays are performed in accordance with the NPIP Program Standards or other procedures approved by the Administrator in accordance with § 147.53(d)(1) and reported as described in paragraph (f) of this section. A satisfactory evaluation will result in the laboratory being recognized by the NPIP office of the Service as an authorized laboratory qualified to perform the assays provided for in this part.
(a)Check-test proficiency. The NPIP will serve as the lead agency for the coordination of available check tests from the National Veterinary Services Laboratories. The authorized laboratory must use a regularly scheduled check test for each assay that it performs.
(b)Trained technicians. The testing procedures at the laboratory must be run or overseen by a laboratory technician who has attended and satisfactorily completed Service-approved laboratory workshops for Plan-specific diseases within the past 4 years.
(c)Laboratory protocol. Official Plan assays must be performed and reported as described in the NPIP Program Standards or in accordance with other procedures approved by the Administrator in accordance with § 147.53(d)(1). Assays must be performed using control reagents approved by the Plan or the reagent manufacturer.
(d)State site visit. The Official State Agency will conduct a site visit and recordkeeping audit at least once every 2 years. This will include, but may not be limited to, review of technician training records, check test proficiency, and test results. The information from the site visit and recordkeeping audit will be made available to the NPIP upon request.
(e)Service review. Authorized laboratories will be reviewed by the Service (NPIP staff) every 3 years. The Service's review may include, but will not necessarily be limited to, checking records, laboratory protocol, check-test proficiency, technician training, and peer review.
(1) A memorandum of understanding or other means shall be used to establish testing and reporting criteria to the Official State Agency, including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service.
(g)Verification. Random samples may also be required to be submitted for verification as specified by the Official State Agency.