W. Va. Code R. § 64-111-4

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 64-111-4 - Approval of laboratories

4.1. A laboratory intending to identify, collect, handle and conduct tests on samples and test samples and other items used by a grower/processor in the growing and processing of medical cannabis as required under the Act and this rule must submit an application for approval to the bureau on a form and in a manner prescribed by the bureau, in addition to the prescribed fee. The application is available on the bureau's website.

4.2. An application submitted under this section must include the following information:

4.2.a. The name and address of the laboratory applicant or its authorized agent.

4.2.b. The name and address of the owner of the laboratory applicant, and, if applicable, the medical or pharmacy licensure information regarding the owner.

4.2.c. The name of the laboratory applicant's proposed director and technical personnel who are or will be employed by the laboratory at the location to be approved.

4.2.d. A copy of the laboratory applicant's most recent valid certificate of accreditation granted from an ILAC MRA recognized accreditation body.

4.2.e. Copies of the standard operating procedures and sampling procedures adopted by the laboratory applicant and approved by the accreditation body that issued the certificate of accreditation to the laboratory applicant.

4.2.f. A list of the specialized laboratory equipment utilized or to be utilized by the laboratory applicant in its testing operations, including the manufacturer's name and the serial and model number of the equipment, and other specifications as may be required by the bureau.

4.2.g. A description of the accredited tests which are capable of being conducted by the laboratory applicant at the location to be approved.

4.2.h. A description of the laboratory applicant's quality assurance program, which must be in compliance with section 13 of this rule.

4.2.i. The procedures to be followed to establish chain of custody when collecting samples or test samples.

4.2.j. A copy of the evaluation process that the laboratory applicant uses or will use to monitor, evaluate and document the competency of employees when testing samples and test samples and overseeing quality assurance controls.

4.2.k. Other information required by the bureau.

4.3. By submitting an application for approval to the bureau, a laboratory applicant consents to an investigation, to the extent deemed appropriate by the bureau, of the laboratory applicant's ability to meet the requirements under the Act and this rule.

4.4. An application for approval submitted under this rule must include a statement that a false statement made in the application is punishable under the applicable provisions of W. Va. Code § 61-3-37.

4.5. The bureau may issue an approval under this rule if the bureau determines that the laboratory applicant is financially and professionally suitable to conduct the testing required under the Act and this rule.

W. Va. Code R. § 64-111-4