June 11, 2021

Department of Health
ADMINISTRATIVE ORDER No. 2021 – D037

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.

Through the years, several laboratory technological advancements have been introduced. As such, certain provisions in the current Administrative Order (AO) No. 2007-0027, dated August 22, 2007, titled “Revised Rules and Regulations Governing the Licensure and

Regulation of Clinical Laboratories in the Philippines,” may have become outdated. This

policy is being issued to align the laboratory procedures with the requirements of AO 2020- 0047 titled “Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines.”

The necessity to review the current AO and to revise and update the minimum standards and technical requirements for licensing clinical laboratories in the Philippines is aligned with the main objective of Republic Act No. 11223 or the Universal Health Care Act which is to guarantee access to quality and affordable health products, devices, facilities and services.

Click here to download entire AO No. 2021 – D037
New Rules and Regulations Governing the Regulation of
Clinical Laboratories in the Philippines

Click here to download only Annex A only.
LICENSING STANDARDS FOR CLINICAL LABORATORY

Click here to download only Annex B1 only.
ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL LABORATORY

Click here to download Annex B2 only.
EQUIPMENT / INSTRUMENTS / GLASSWARE /SUPPLIES/REAGENTS PER AREA OF ACTIVITY / SERVICE CAPABILITY OF GENERAL CLINICAL LABORATORY

Click here to download Annex C only.
PROHIBITED ACTS IN THE OPERATIONS OF CLINICAL LABORATORIES

Click here to download Annex D1 only.
PLANNING AND DESIGN GUIDELINES FOR GENERAL CLINICAL LABORATORY

Click here to download Annex D2 only.
CHECKLIST FOR REVIEW OF FLOOR PLANS GENERAL CLINICAL LABORATORY

Click here to download Annex E only.
GUIDELINES IN SECURING FOR REMOTE COLLECTION PERMIT FOR CLINICAL LABORATORIESScanned Image

Click here to download Annex F only.
APPLICATION FORM FOR CERTIFICATE OF REGISTRATION FOR RESEARCH AND TEACHING CLINICAL LABORATORY