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.

Initial HIV/AIDS-Related Testing Certificate Request

If you require an initial HIV/AIDS-related testing certificate, please contact this office for the application and requirements.
 

Renewing an HIV/AIDS-Related Testing Certificate

HIV/AIDS-related testing certificates must be renewed annually. Your current certificate will have an expiration date listed under the director’s name, ex. “Valid 1/1/2018 to 12/31/2018.”  Your certificate is valid until the certificate date of 12/31/20XX.

This office will initiate certificate renewals by emailing a survey link to the two contacts you provided during the previous year’s certificate renewal. The certificate renewal process will begin sometime between September 1 and October 31 of each year.  The renewal for HIV in-state and HIV out-of-state certificates will be completed in a staggered fashion to allow for easier processing. To help this process, complete and submit the required items by your designated due date (which will be provided in your annual email). You may make online payments during the designated renewal period using the link below:
Online Payment for Annual HIV/AIDS-Related Medical Testing Certification Renewal
 

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):
  • 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.
To ensure continuous compliance, any changes to information regarding the facility, director, technical supervisor (high complexity only) or testing menu/methodology must be submitted to OLS via this FORM within 30 days of the change.

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.
 

2019 Certified HIV/AIDS-Related Testing Labs & Facilities


Contact Information

WV Office of Laboratory Services
ATTN: Training & Evaluation Section
167 11th Avenue
South Charleston, WV 25303
 

Training & Evaluation Support Secretary

Amy Grandstaff
Email: amy.e.grandstaff@wv.gov
Phone: 304-558-3530 extension 58904
Fax: 304-746-0658
 

Training & Evaluation Supervisor

Dana Stillwagon, MLS(ASCP)CM
Email: dana.m.stillwagon@wv.gov
Phone: 304-558-3530 extension 58916
Fax: 304-746-0658