Accreditation of clinical laboratories in the Philippines.

ABSTRACT

In order to assure the reliability of the results of laboratory services, clinical laboratories are regulated in the Philippines. This started with the passage of the Clinical Laboratory Law in 1965, which required the Licensing of clinical laboratories by the Bureau of Research and Laboratories, Department of Health (BRL, DOH) before they can operate. Standards were set for the various types of laboratory services. In 1988, the minimum standards of laboratory services were formulated for three categories, ie, primary, secondary and tertiary categories. Subsequently, to permit clinical laboratories to offer 'special service', accreditation of clinical laboratories was instituted. In 1968, the Philippine Society of Pathologists (PSP) decided to accredit clinical laboratories for Residency Training Program in Anatomic and Clinical Pathology. The following year after the passage of the Medical Technology Law, the BRL, DOH began accrediting clinical laboratories that trained Medical Technology Interns. A few years later, the BRL, DOH started to accredit clinical laboratories who did Water Analysis. In 1989, after realizing the serious implications of HIV Testing, the DOH mandated the BRL, DOH to set standards for clinical laboratories performing HIV testing. In 1997, upon request of the Philippine Health Insurance Corporation (PhilHealth), the PSP formulated and submitted standards for the accreditation of clinical laboratories, both hospital and free-standing, for reimbursement of fees for laboratory services rendered to patients enrolled in the PhilHealth social insurance program. In 2000, the Philippine Council for Accreditation of Healthcare Organizations (PCAHO) approved the Standards for the accreditation of Hospitals for the provision of quality medical services. Included were the standards for the Department of Pathology.