Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2005-0027)
The main objective is to ensure utmost safety and quality in the performance of HIV testing by laboratories.
An applicant is the owner or head of a clinical laboratory or blood center securing permission to operate an HIV testing laboratory.
Screening tests for HIV antibody such as Enzyme Immunoassay (EIA) and Particle Agglutination (PA), and confirmatory tests like Western Blot (WB), Immunofluorescence (IF), and Radio Immuno-Precipitation Assay (RIPA) are covered.
The laboratory must have a licensed Medical Technologist trained in HIV Proficiency Testing certified by the NRL-SACCL/SLH, and their HIV Proficiency Certificate must be conspicuously posted.
HIV test kits must be registered with the Bureau of Food and Drugs (BFAD) and have a valid Certificate of Product Registration (CPR). For screening blood donors, only BFAD registered kits shall be used.
An intention letter to provide HIV testing services, list of personnel with PRC IDs and certificates of HIV proficiency training, list of equipment with specifications, and current Certificate of EQAS Participation from NRL-SACCL/SLH (for renewal) must be submitted.
Violators may be liable under the Clinical Laboratory Law (R.A. 4688), National Blood Services Act (R.A. 7719), or Philippine AIDS Prevention and Control Act (R.A. 8504) and face penalties including suspension or revocation of their license to operate.
NRL conducts confirmatory testing, training, surveillance, and external quality assurance programs, and makes final decisions on conflicting results.
Failure to submit such samples is a violation of the order and may result in penalties including suspension or revocation of the laboratory’s license.
An aggrieved party may file a notice of appeal within ten (10) days after receipt of the decision to the Office of the Secretary, which will review and render a final and executory decision.