W. Va. Code R. § 64-64-14

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

Section 64-64-14 - Quality Assessment of Laboratories Conducting HIV Tests

14.1. Laboratories Required to be Approved.

14.1.a. All laboratories conducting HIV testing in this State or providing HIV testing results for use in this State shall be approved by the Bureau.

14.1 .b. A laboratory located in West Virginia and seeking approval shall:

14.1.b.1. Show that it complies with the applicable requirements of W. Va. Code § 16-3C-1, et seq. and this rule;

14.1.b.2. Complete application forms when seeking initial approval or when there is a change in director, owner, location or testing method;

14.1.b.3. Be certified to perform waived or non-waived (moderate or high) complexity HIV testing following at a minimum the test categorization requirements in accordance with the provisions of the federal regulations promulgated pursuant to the Clinical Laboratory Improvement Amendment (CLIA-1988) 42 CFR Part 493, as revised October 1, 2006; and

14.1.b.4. Pay a fee of thirty dollars annually for each laboratory providing HIV testing located in West Virginia.

14.1.c. A laboratory located outside of West Virginia conducting HIV testing on West Virginia patients is eligible for approval only if it is approved for non-waived (moderate or high complexity) laboratory testing by the federal government regulations promulgated pursuant to CLIA-88 as revised October 1, 2006 and/or Centers for Medicare and Medicaid Services (CMS) approved accreditation agency. The laboratory shall complete an application and submit a forty dollar fee when seeking initial approval. Each out-of-state laboratory shall also submit an annual renewal fee of forty dollars to the Office of Laboratory Services.

14.2. Laboratory Director and Personnel Qualifications.

14.2.a. The laboratory director and personnel shall at a minimum meet the qualifications set forth by the federal government pursuant to CLIA for certification of laboratories 42 CFR Part 493, Laboratory Requirements, as amended in the October 1, 2006, edition of the Federal Register (60 FR 20035), are hereby incorporated by reference.

14.2.b. The person specified as the laboratory director on the CMS issued CLIA certificate is ultimately responsible for the reliability of HIV testing. The laboratory director shall be a licensed medical professional acting within the scope of his or her license.

14.2.C. For waived HIV testing methods only, while there are no formal educational requirements for testing personnel, the director shall assure the testing personnel are properly trained and competent.

14.3. Quality Assessment Standards.

A laboratory requesting approval shall demonstrate that a quality assessment program acceptable to the Bureau is in effect for verification and assessment of accuracy, measurement, precision, and detection of laboratory errors. This demonstration shall be evidenced, when applicable, in part by:

14.3.a. The selection of test methods appropriate to the needs of persons served by the laboratory;

14.3.b. The use of quality controls and calibrating standards;

14.3.c. The recording of the acceptable limits and the results of controls and calibrating standards;

14.3.d. The recording of quality assessment activities; including, but not limited to, calibration, quality control, corrective action, preventative maintenance and patient test management;

14.3.e. The labeling and dating of all reagents, solutions, standards, and quality control materials;

14.3.f. Following HIV test method manufacturer requirements approved by the Federal Food and Drug Administration (FDA); and

14.3.g. Maintaining a site specific manual containing all procedures and policies currently in use, which shall include action to be taken when control results are outside the acceptable limits and the procedure for reporting positive HIV test results to the Bureau along with protocols for reporting HIV testing to the Bureau.

14.4. Proficiency Testing, Personnel Competency Assessment.

Laboratories shall participate in a CLIA approved HIV proficiency testing survey or an alternative HIV testing personnel competency assessment program approved by the Bureau and in accordance with CLIA-88 Proficiency testing requirement by test complexity. The assessment shall be conducted biannually and satisfactory performance by the laboratory is mandatory. The laboratory shall forward proficiency testing survey results to the Bureau.

14.5. On-site Inspection.

The Commissioner or his or her designee may conduct an on-site inspection or a paper or electronic survey to determine compliance with this rule initially prior to approval, and thereafter as frequently as the Commissioner considers necessary to insure compliance with this subsection. The Bureau has the right of entry upon proper identification at times judged necessary during operating hours in order to conduct the inspections.

14.6. Certificate of Approval; Revocation.

14.6.a. The Commissioner shall issue certificates of approval for a laboratory to perform HIV testing upon initial approval and on an annual basis thereafter pursuant to the conditions listed in this rule. Certificates issued shall contain the name and location of the laboratory, a laboratory code number, the name of the laboratory director and the date of expiration of the certificate.

14.6.b. Laboratories shall notify the Bureau when there is a change in ownership, laboratory director, testing method or location of the testing laboratory. In the case of mobile laboratory programs, the certificate shall be issued to the mobile laboratory's home-based address.

14.6.c. The Commissioner may revoke or suspend a laboratory's approval if the laboratory:

14.6.c.1. Performs unsatisfactorily in on-site inspections;

14.6.c.2. Fails to comply with this rule and all applicable provisions of W. Va. Code § 16-3C-1, et seq.;

14.6.c.3. Fails to report positive test results to the Bureau in accordance with W.Va. Code § 16-3C-8B and this rule; or

14.6.c.4. Closes.

W. Va. Code R. § 64-64-14