Published on June 11, 2021, is known as the New Rules and
Regulations Governing the Regulation of Clinical Laboratories in the Philippines. 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 Primacy Care Facilities in the Philippines”
DOH A.O. 2021-0037
This Order serves as the new guidelines in the licensing of diagnostic clinical laboratories in the Philippines which shall ensure accountability of the laboratory on generation of accurate, precise, and reliable laboratory results in a timely manner for continuous compliance.
DOH A.O. 2021-0037
This is a facility that is involved in the (a) pre-analytical, (b)analytical, (c) and post-analytical procedures, where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases.
Clinical laboratory (CL)
What are tests included but not limited to the following disciplines (as mentioned in the module under clinical laboratory)?
- anatomic pathology
- clinical chemistry
- clinical microscopy
- endocrinology
- hematology
- immunology and serology
- microbiology
- toxicology
- molecular diagnostics
- nuclear diagnostics
Who shall:
1. Continuously comply with the rules and regulations, licensing standards and requirements for CL, as provided in this Order and related issuances.
- Participate in EQAP that may be administered by a designated NRL or other local and international EQAP approved by the DOH, surveys and other activities that will be required from them by the DOH.
- In times of Pandemic of Public Health Event, be mandated to submit timely reports and data.
DOH-Licensed Clinical Laboratories
What Administrative Order shall apply to all individuals, agencies, partnerships or corporations, whether private or government-owned, involved in the application for DOH license to operate and those in operation of diagnostic clinical laboratories in the Philippines?
DOH A.O. 2021-0037
What Order shall also apply to the Bangsamoro Autonomous Region in Muslim Mindanao (BARMM) subject to the applicable provisions of RA11054 or the “Bangsamoro Organic Act” and subsequent rules and policies issued by the Bangsamoro Government?
DOH A.O. 2021-0037
Clinical Laboratories in the Philippines are classified as:
A.
B.
C.
D.
Ownership (A), Function (B), Institutional Character (C), and Service Capability (D)
Clinical Laboratories (Classification by Ownership)
Government and Private
Clinical Laboratories (Classification by Ownership)
- Operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city or municipality), any other political unit or any department, division, board or agency
Government
Clinical Laboratories (Classification by Ownership)
- Privately owned, established and operated by any individual, corporation, association or organization
Private
Clinical Laboratories (Classification by Function)
Clinical Pathology, Anatomic Pathology, and Molecular Pathology
Clinical Laboratories (Classification by Function)
- Deals with the chemical and cellular analyses of blood and other body fluids (includes, but not limited to, clinical chemistry, clinical microscopy, toxicology, therapeutic drug monitoring , immunology and serology, hematology and coagulation), identification and examination of microbes and parasites (bacteriology/parasitology/mycology/virology).
Clinical Pathology
Clinical Laboratories (Classification by Function)
- Provides processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues, such as, but not limited to, surgical pathology, cytopathology, immunohistochemical techniques, autopsies, and forensic pathology.
Anatomic Pathology
Clinical Laboratories (Classification by Function)
- Deals with the analysis of certain genes, proteins and other molecules in samples from organs, tissues, or bodily fluids in order to diagnose disease and/or to guide the prevention and treatment of disease based on the principles, techniques and tools of molecular biology as they are applied to diagnostic medicine in the laboratory.
Molecular Pathology
Clinical Laboratories (Classification by Institutional Character)
- A laboratory that is located within the premises and operates as part of a DOH licensed health facility.
Institution Based
Clinical Laboratories (Classification by Institutional Character)
- A laboratory that operates independently and is not attached to any DOH licensed health facility
Non-institution based / Free-standing
Clinical Laboratories (Classification by Service Capability - Clinical and Anatomic Pathology)
