Okla. Admin. Code § 35:15-5-2

Current through Vol. 41, No. 24, September 3, 2024

Section 35:15-5-2 - Laboratories

(a)Privately owned laboratories requesting authority to perform certain procedures. Privately owned laboratories requesting authority to perform certain official laboratory procedures must apply for said approval on an application provided by the Assistant Director (AD) of the United States Department of Agriculture (USDA) Animal Plant Health Inspections Service (APHIS) Veterinary Services (VS) Surveillance Preparedness Response Service (SPRS) which provides for a joint signature of recommendation for approval of the AD and the State Veterinarian or designee.

(b)Initial request for laboratory approval. All initial requests for laboratory approval shall be made to the AVIC or State Veterinarian or designee. Laboratories must specify those tests which they are requesting approval to perform. These tests include, but are not limited to, Bluetongue, Bovine Leukosis, Equine Infectious Anemia, Johne's Disease, Pseudorabies, Bovine Trichomoniasis, and those diseases that are reportable to the Department.

(c)Requirements prior to approval of laboratory. Prior to approval of any laboratory to conduct any official laboratory procedure, the following requirements must be met:

(1) An authorized representative of the Department or USDA will review with laboratory officials the responsibilities, regulatory and technical, inherent in conducting and reporting official tests.

(2) The physical facilities of the laboratory will be inspected by a Federal or State representative. Inspection results will be recorded on a laboratory inspection worksheet. This inspection must be determined as satisfactory before approval will be considered.

(d)Procedures to be followed by approved laboratories.

(1) Only antigen licensed by APHIS or supplied by National Veterinary Services Laboratories (NVSL) and accompanying antiserum will be used.

(2) All tests will be conducted according to protocol provided by NVSL.

(3) Official test results will be reported promptly to State or Federal regulatory officials and the veterinarian submitting the sample.

(4) Only samples submitted by a licensed veterinarian, state or federal animal health official, or military veterinarian will be accepted.

(5) Information with sample submission shall include:

(A) Name and address of submitting veterinarian.

(B) Name and address of owner.

(C) Location (including county) or animal(s) at time of test.

(D) Age, breed, and sex of animal tested.

(E) Identification of animal(s) tested, which may include eartag, tattoo, registration number or physical description adequate to provide positive individual identification of animal(s) tested.

(6) Periodic proficiency testing will be required for continuous authority to conduct approved testing. NVSL will supply the samples and evaluate test results.

(7) If any proficiency test is failed, the approved laboratory shall immediately notify the Department and shall suspend further testing until recertified by NVSL.

(8) Incomplete tests charts shall not be accepted and the sample shall not be tested until the chart is completed.

(e)Training.

(1) Personnel who perform any approved official test must be recognized as qualified by Veterinary Services and the Department. The AD and the State Veterinarian or designee must recommend personnel for approval and training by NVSL.

(2) The person(s) responsible for conducting official tests for private laboratories will be trained by NVSL.

(3) With approval of the AD and the State Veterinarian or designee, personnel previously trained by NVSL for Federal, State, and University laboratories may train others in the laboratory to conduct official tests. Training will include regulatory responsibility.

(4) NVSL will certify training of personnel for Federal, State, and University laboratories by proficiency testing which must be completed in accordance with standards established by NVSL, and maintained by periodic proficiency testing.

(f)Evaluation of personnel. The AD, State Veterinarian or designee, and NVSL will evaluate personnel who do not successfully complete proficiency testing in order to determine if additional training is necessary.

(g)Laboratories approved to conduct official tests. Laboratories approved to conduct official tests must notify in writing the AD, State Veterinarian or designee and NVSL when any person trained by NVSL to conduct official tests is no longer employed. If no one with approved training is available to conduct these tests, approval of the laboratory will be cancelled.

(h)Recommendation for approval. The AD and the State Veterinarian or designee must recommend approval of the laboratory prior to obtaining official status. A jointly signed memorandum and the originals of all completed documents of application and approval shall be mailed through the appropriate Regional Director of APHIS for his or her concurrence to the Director of NVSL.

(i)Approval of laboratories. After the requirements of training have been satisfactorily completed, the laboratory will be approved by the Director of NVSL and will be so notified of approval by a telegram or a letter signed by the Director of NVSL.

(j)Removal or suspension of laboratory approval.

(1) Laboratory approval will be removed or suspended by the Director of NVSL or State Veterinarian or designee when any criteria are not met. If the laboratory is approved to perform tests for more than one disease, removal or suspension will apply only to the disease for which proficiency is not maintained. The laboratory will be informed of removal or suspension by a telegram signed by the Director of NVSL, or by certified letter from the Department, or both.

(2) Failure to maintain competency or failure to perform within any established protocol, shall constitute a violation of this Section and shall submit the laboratory to actions outlined under the Administrative Procedures Act of the State of Oklahoma, above and beyond any action deemed appropriate by APHIS.

Okla. Admin. Code § 35:15-5-2

Amended by Oklahoma Register, Volume 31, Issue 24, September 2, 2014, eff. 9/12/2014

Amended by Oklahoma Register, Volume 33, Issue 24, September 1, 2016, eff. 9/11/2016

Amended by Oklahoma Register, Volume 34, Issue 24, September 1, 2017, eff. 9/11/2017

Amended by Oklahoma Register, Volume 36, Issue 23, August 15, 2019, eff. 9/14/2019