New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines
Administrative Order No. 2021-0037

I. RATIONALE

By virtue of Republic Act No. 4688 s. 1966, “An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof, and for Other Purposes,” the Department of Health (DOH) through the Bureau of medical Services, now known as the Health Facilities and services Regulatory Bureau (HFSRB), was mandated to ensure public health, safety and welfare through enforcement of the Act and was authorized to issue such rules and regulations as may be necessary to carry out the law. Clinical laboratory services play an important role in the diagnosis, treatment, prevention and control of disease. Thus, it is imperative that the laboratories generate accurate, precise and reliable laboratory test results in a timely manner to aid the physicians in assuring the quality of patient care.

Download AO 2021-0037