Objective
- To ensure utmost safety and quality in the performance of HIV testing by laboratories
Scope
- Covers laboratory procedures relating to HIV antibody testing including:
- Screening tests (EIA, Particle Agglutination, other tests)
- Confirmatory tests (Western Blot, Immunofluorescence, RIPA, other supplemental tests)
Definitions
- Applicant: Owner or head of laboratory or blood center applying for HIV testing operation
- BFAD: Bureau of Food and Drugs
- BHFS: Bureau of Health Facilities and Services, DOH regulatory authority for HIV testing labs
- Blood Center: DOH-authorized facility with capabilities including donor recruitment, blood collection, processing, storage, and infectious marker testing
- Confirmatory/Supplemental Test: Tests to confirm reactive screening results such as Western Blot, LIA, IF, PCR
- DOH: Department of Health
- EQAS: External Quality Assessment Scheme for monitoring laboratory performance
- HIV: Human Immunodeficiency Virus
- HIV Test Kit: Registered reagents for detecting HIV antibodies, antigen, genome or particles
- HIV Testing: Detection of HIV infection through laboratory assays
- NRL: National Reference Laboratories designated for confirmatory testing and quality assurance
- Screening Test: Initial serological test for HIV antibody or antigen
- Specimen: Biological sample submitted for HIV testing
General Policies and Guidelines
- Only licensed clinical laboratories or blood centers designated by NVBSP can operate HIV testing labs
- Operations must be included in the License to Operate
- BHFS or CHD may conduct unannounced inspections
- HIV testing unit must be part of an existing clinical laboratory or blood center
- Medical Technologists must be HIV proficiency-certified, with workload governed by NRL guidelines
Specific Operational Requirements
- Physical Plant: Adequate lab space, proper lighting, ventilation, water supply, decontamination area, and counseling facility
- Personnel: Licensed Medical Technologist with NRL-certified HIV proficiency training; certificate must be displayed
- Equipment and Supplies: Appropriate equipment and BFAD-registered HIV test kits (only BFAD-registered kits for blood donor screening)
- Laboratory Reports:
- Must include patient and test details, kit information, and signatures of analysts and lab heads
- Maintain comprehensive records of tests, results, and referrals
- Reactive samples must be referred to designated National Reference Laboratories
- Quarterly reports of HIV testing and results must be submitted to DOH-National Epidemiology Center
- External Quality Assessment Scheme (EQAS): Participation supervised by NRL-SACCL/SLH with certification following satisfactory proficiency
Procedural Guidelines for Accreditation
- Submission requirements:
- Letter of intent for HIV testing services
- List of personnel with valid licenses and proficiency certificates
- Equipment list with specifications
- Current Certificate of EQAS participation (for renewal)
- BHFS conducts on-site inspection
- BHFS approves or disapproves application within 60 days; non-action considered approval
- Approved labs get HIV testing added to their License to Operate
Violations
- Making false statements on documents
- Owner/manager convicted of criminal offenses related to laboratory operation
- Use of unregistered HIV kits or issuing incomplete reports
- Failure to submit reactive samples for confirmatory testing
- Failure to report confirmed positive cases to DOH AIDS registry
- Non-participation in authorized EQAS
- Failure to submit quarterly reports
- Refusal of BHFS/CHD monitoring visits
- Any acts contrary to accepted clinical/blood center practices
Penalties
- Subject to penalties under Clinical Laboratory Law (RA 4688), National Blood Services Act (RA 7719), Philippine AIDS Prevention and Control Act (RA 8504)
- Sanctions may include suspension or revocation of license to operate
Appeal Process
- Aggrieved parties may file appeals within 10 days to the Office of the Secretary
- BHFS must submit necessary documents for review
- Decision of the Secretary is final and executory
Separability Clause
- Invalidity of any provision does not affect the validity of other provisions
Repealing Clause
- Supersedes all previous inconsistent administrative orders
Effectivity
- Effective 15 days after publication in a newspaper of general circulation