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.
