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Overview of Clinical Laboratory Categories and Guidelines in the Philippines

• There are four categories of clinical laboratories in the Philippines: primary, secondary, tertiary, and limited service capability.
• Primary category laboratories offer routine hematology, qualitative platelet determination, routine urinalysis, routine focalysis, and blood typing.
• Secondary category laboratories offer the minimum service capabilities of primary labs plus routine clinical chemistry, quantitative platelet determination, cross-matching, Gram staining, and KOH.
• Tertiary category labs offer the minimum service capabilities of secondary labs plus special chemistry, special hematology, immunology, microbiology, and aerobic and anaerobic culture and sensitivity.
• Limited service capability labs provide tests required for a specific service in institutions such as dialysis centers and social hygiene clinics.
• Special clinical laboratories offer highly specialized services not provided by general clinical labs, such as assisted reproduction technology and molecular pathology.
• Clinical labs must comply with standards and technical requirements formulated by the Bureau of Health Facilities and Services (BHFS) to obtain a license.
• Labs operated exclusively for research and teaching are exempt from licensing but must register with the BHFS.
• NRLs designated by the DOH are covered by the license of the hospital's clinical lab, while independent NRLs must be accredited or certified by an international or local body.
• Physician's office labs (POLs) must obtain a clinical lab license if they issue official results, perform more than monitoring exams, or cater to patients beyond their own.
• Point of care testing (POCT) in hospitals must be managed and supervised by the hospital's licensed clinical lab.
• Special clinical labs must register with the BHFS but do not need a license and must be headed by a pathologist or licensed physician trained in their specialized services.
• National reference labs (NRLs) such as the Research Institute for Tropical Medicine and San Lazaro Hospital offer confirmatory testing for diseases like dengue, HIV/AIDS, and tuberculosis.