Accreditation of clinical laboratories in the Philippines.

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.

Second national external quality assessment scheme in hematology: the Philippine experience.

The Philippine Council for Quality Assurance In Clinical Laboratories has conducted two National External Quality Assessment Schemes (NEQAS) in Hematology. The first survey was conducted in December 1999 and the second in August 2000, with 95 and 187 laboratories, using mostly automated analyzers, participating respectively. Control materials were distributed during a two-week period by human network, and analyzed over a six to eight week period. For the first survey, only 36 laboratories (38.0%) submitted results. Data was divided into 4 peer groups based on the manufacturer. Since most of the samples were hemolysed upon analysis, only WBC and HGB parameters were evaluated. No outliers were detected in each peer group after analysis by the 'Peer Group Mean and SDI' method. Using the clinical laboratory improvement act of 1988 proficiency testing criteria (CLIA'88), only 5 results (13.9%) were unsatisfactory for WBC, and all results were satisfactory for HGB. For the second survey, 87 laboratories (47%) responded. Data was divided into 5 peer groups. There were few incidents of sample deterioration. Although majority of the coefficient of variations were acceptable, about 23 (12.6%) participants showed abnormality in at least one parameter after analysis by the 'Peer Group Mean and SDI'. Using CLIA'88, 5 WBC (6.5%), 6 RBC (7.6%), 8 HGB (9.7%), 15 HCT (19.0%), and 7 PLT (8.0%) results were unsatisfactory. In summary, the first NEQAS study served as a pilot study. Valuable lessons were learned for the improvement of the second NEQAS. The second NEQAS study was marked by a much larger sample size and better results.