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nepuillic 8 the Philippines Me Departuent of Reslth Manila Acninigegative Order No BSA. sertes (267 Jariuary 2, 1989 # RULES AND REGULATIONS GOVERNING THE ACCREDITATION OF LABORATORIES PERFORMING HIV TESTING Sec. 1 = Picle: These Rules and Regulations shall be known as "RULES AND REGULATIONS GOVERNING THE ACCREDETATION” of LABORATORI2S PRE (G HIV TESTING". Se. 2° = sueteiiey: “these in accordance to B.A. 4688 (Clinical Laboratory Law) and ~ les an@ ‘regulations axe issued RA, 1517 (Blood Bank Law) consistent with E.0. 119 (eoxgenization Act of the Ministry of Health). / See, 3 - Purpose: these rules and reguletions are promulgéced. to. protect and promote the health of the people dy regyfating che performance ang assucing the quality of RIV cesting in labératories and bloo¢ den! © licenseé according to the implementing Rules and Regulacions of R.A. 468% and R.A. 1517. Sec. 4 ~ Scope: 4.1 "The regulations eubodied heres shall “apply co any pexson, firm, corporation, laboratory." or blood bank performing or seeking to perform HIV testing in the Philippines, for the public for dLegnostic i or pudlic health purposes. HIV test: @ shall include “ the determination of ‘the presence. of antibody, antigen/protein, viral particles in 3 clint speciten indicating infection by Hunan Tmunddefictency { Virus (RIV). Sec. 5 - Regulatory Authority: The Accreditation. of ‘xiv + Tpsting Laboratories/Blood Banks under these rules’ and regulations skall be exercised by the Department of Health shrough’ the- Bureau of Research and Laboratories in the Office for “Stendarcs and Regulation. Sec. 6 ~ Labo: ocedures 2 teouiring Accreditetios he: following sboratory procedures shall 6.1 Any of Adainistrecive uréer page 2 6.3 require accreditation as a HIV Testing Laboratory: 1) Screening tests for HIV antibody 1.1 Enzyme Immunoassay (ETA) 1.2 Particle Agglutination (PA) 1.3, Others 2) Supplemental (Confirmatory) Tests for HIV Antibody 2.1 Western Blot (WB) 2.2 immunoflourescence (IF) 2.3. Radioinmuno Precipitation Assay, (RIPA) 2.4 Others 3) Other laboratory procedures such as testing for HIV antigen, culture of HIV, etc. No Laboratory shall be allowed to perform HIV testing without accreditation by the Department of Health through the Bureau of Research and Laboratories. No HIV clearance certificate shall be authenticated by the DOK unless the laboratory procedure has been performed by a laboratory accredited. in accordance to these rules and regulations. Sec. 7 - Accreditation Requirements for a HIV Testing Laboratory: (Technical Standards) . All clinical laboratories or blood banks shall be required to demonstrate compliance with the following Technical Standards as @ - requirement to accreditation: 1) The clinical laboratory or blood bank shall be duly licensed by the Bureau of Research and Laboratories. 2) The laboratory shall be headed by and under the direction and supervision of a duly Licensed physician who ie certified by the Philippine Board of Pathology or Philippine Board of Hematology and Blood Transfusion. 3) The laboratory shall be staffed by medical technologists duly registered with the Board of Medical Technology, who have. undergone acceptable training in HIV Testing duly certified HB Administrative Oréér Page 3 by a training laboratory. 4) The physical plant shall be housed in well-lighted and ventilated, dust-free areas with an adequate supply of water. ‘The space appropriately furnished, should be sufficient to accomodate the activities needed for HIV Testing. 5) Equipment, glassware and supplies: The HIV Testing Laboratory shall have the appropriate equipment, glassware and other supplies needed for HIV testing. 5) Reagents: | The laboratory shall utilize reagents, such as HIV kits, which have been registered with the Bureau of Food and Drugs (BFAD). . 7) Report forms - The report forms should “be clear, objective and indicate the type of HIV kit (brand/ manufacturer) utilized. 7.2 The Bureau of Research and Laboratories shall evaluate compliance with such technical standards in accordance to requirements as may be promulgated’ under these Rules and Regulations. oo Sec. 8 = Reporting: Each HIV testing laboratory shall report monthly the number of tests done, results and referrals of seroreactive samples in accordance with the format prescribed by the Bureau of Research and Laboratories. ‘The report shall be accompanied by xerox copies of invoices of purchases | of HIV kits the previous month. Sec. 9 - Referral of Seroreactive Serum Samples: 9.1 ALL serum samples reactive in screening tests (BIA or PA) by private laboratories shall be referred to the Research Institute of Tropical Medicine for confirmation. 9.2 All serum samples reactive in screening tests (BIA or PA) by government laboratories shall be referred to the Bureau of Research and Laboratories for confirmation. The names, age, sex and addresses of persons confirmed | to be seropositive (by WB/IF/RIPA) shall be reported