HIV/AIDS-Related Testing Facility Certification

The Law

The WV AIDS-Related Medical Testing and Records Confidentiality Act (Senate Bill 488) requires that facilities performing on-site HIV and AIDS-related testing on WV patients must be approved and certified by the Bureau of Public Health to legally test these clinical samples. The rule covers laboratories performing waived, moderate, or high complexity HIV and AIDS-related testing on WV residents. This includes both WV facilities and facilities in other states who perform these tests on WV’s residents. Out-of-state facilities include those that function on WV’s borders or are reference labs used by WV facilities for follow-up or confirmatory testing.

HIV/AIDS-Related Testing Certification

If your laboratory requires HIV/AIDS-related testing certification, click HERE to complete an application.

PLEASE NOTE: YOU DO NOT NEED TO BE CERTIFIED IF YOUR FACILITY IS ONLY COLLECTING SPECIMENS TO SEND OUT FOR LABORATORY TESTING.

HIV/AIDS-related testing certification must be renewed annually. The annual cost for HIV certification is $30 for in-state labs and $40 for out-of-state labs. Certificates are valid from January 1 to December 31 of the calendar year for which you apply. The renewal process begins in the fall and renewal notices are emailed to the two contacts provided on the most recent application. To prevent delays, notify us via email when any contact information changes throughout the year. Please include the new contact's name, email address, and phone number.

Reporting & Other Requirements

All facilities with HIV/AIDS-related testing certification must meet the following requirements to maintain their certification (this list may not be all inclusive):

HIV/AIDS-related testing activity must be reported to the DHHR's Office of Epidemiology & Prevention HIV/AIDS Program, per their requirements.

Proficiency testing must be performed twice annually for all HIV/AIDS-related testing. Waived testing facilities may utilize blind samples such as split samples, known patients, or controls in place of purchasing proficiency samples.

Testing personnel must be trained and have annual competency reviews. All training and competency records must be kept.

The facility must have a written QA plan. All QA and QC activities must be documented.

Two levels of quality control must be run each day of patient testing or an IQCP must be in place.

The facility must have a written occupational post-exposure HIV management plan based on current CDC recommendations.

HIV Inspections

This office also conducts on-site inspections of WV HIV approved laboratories to determine compliance with the law. Any non-compliances found during the on-site inspection must be corrected to retain HIV/AIDS-related testing certification. Out-of-state labs are not inspected. However, files are maintained on out-of-state laboratories that report HIV results on WV patients.