Okla. Admin. Code § 35:15-15-34

Current through Vol. 42, No. 8, January 2, 2025

Section 35:15-15-34 - Requirements for approved EIA testing laboratories

(a) No person shall operate an EIA testing laboratory without first obtaining approval from the Board.

(b) Conditions of approval.

(1) Submit a complete application to the office of the State Veterinarian.

(2) Upon receipt of an application, the facility shall be inspected by an authorized agent of the USDA.

(3) A report of the inspection shall be submitted to the State Veterinarian and identify the EIA testing laboratory's compliance with the minimum standards for facilities, equipment, and personnel.

(4) The applicant shall agree in writing to operate the laboratory in conformity with the Department rules and the requirements of the USDA and shall continually meet all requirements during operation of the laboratory.

(5) A determination by the Department that an additional EIA laboratory is necessary in the area.

(c) Operating requirements.

(1) All personnel conducting an official test at an approved laboratory shall receive training prescribed by the National Veterinary Services Laboratories (NVSL).

(2) Approved laboratories shall use USDA licensed ELISA test kits and follow standard test protocols prescribed by NVSL.

(3) Approved laboratories shall maintain a work log clearly identifying each individual sample and test results.

(4) Approved laboratories shall maintain a work log and a file of all submission forms for a period of not less than two (2) years.

(5) All approved laboratories shall report all positive results to an official test for EIA to the State Veterinarian's office within twenty four (24) hours.

(6) A copy of all test charts for positive Equidae shall be sent to the State Veterinarian's office within seventy two (72) hours.

(7) Approved laboratories shall not test samples until an officially completed test chart is received.

(d) Inspections, proficiency tests, and licenses.

(1) The USDA APHIS VS shall randomly and without prior notification collect samples and inspect the facilities and records of all EIA laboratories in Oklahoma at least one (1) time per year.

(2) All records required to be maintained by approved laboratories shall be open to inspection by state or federal employees during normal business hours.

(3) All approved laboratories shall pass annual proficiency test requirements administered by the NVSL.

(6) Each approved laboratory shall obtain a license on an annual basis.

(A) The annual license fee shall be Two Hundred Fifty Dollars ($250.00).

(B) The annual license shall expire on January 31 of each calendar year.

(C) The renewal license application shall be submitted no later than January 31 of each calendar year.

(D) A renewal application received or postmarked after January 31 shall be in violation of these rules.

(E) Failure to renew may result in disapproval of the laboratory.

(F) A fee waiver may be granted to an EIA laboratory at a university or state agency.

(e) An EIA laboratory may have its approval cancelled if the Department finds that the laboratory has failed to meet the requirements or has falsified records or reports.

(f) Any action taken by the Department to cancel laboratory approval shall conform to the Administrative Procedures Act.

(g) The Department may deny the application of any EIA laboratory if it fails to meet any criteria required by the Department.

(h) Approved laboratories shall only perform the ELISA test.

(i) The Department may at its discretion in limited and approved circumstances grant approved laboratories the ability to perform the AGID test for equine. The limited exception shall be detailed in a written agreement between the Department and the approved laboratory.

(j) Any approved EIA laboratory shall resubmit all application information for approval by the Department upon a change in ownership of the facility or a change in location of the facility.

Okla. Admin. Code § 35:15-15-34

Added at 12 Ok Reg 3388, eff 7-1-95 (emergency); Added at 13 Ok Reg 1847, eff 6-14-96; Amended at 17 Ok Reg 2821, eff 7-13-00; Amended at 19 Ok Reg 1927, eff 6-27-02; Amended at 22 Ok Reg 692, eff 5-12-05; Amended at 24 Ok Reg 1746, eff 6-25-07; Amended at 27 Ok Reg 1105, eff 7-1-10

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

Amended by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021

Amended by Oklahoma Register, Volume 41, Issue 22, August 1, 2024, eff. 8/11/2024