QuestionsQuestions (ADMINISTRATIVE ORDER NO. 59, S. 2001, NOVEMBER 19, 2001)
It is issued to implement R.A. 4688 (Clinical Laboratory Law) consistent with E.O. 102 (redirecting DOH functions). Its purpose is to protect and promote public health by ensuring clinical laboratories are properly managed with adequate resources and comply with quality standards.
It applies to entities performing clinical laboratory activities involving examination and analysis of human samples (tissues, fluids, secretions, excretions) and related materials to determine existence of pathogenic organisms, pathologic processes, or conditions.
No. The regulations do not include government laboratories doing limited examinations limited to: acid-fast bacilli microscopy, malaria screening, and cervical cancer screening, provided their services are declared as extension of a licensed government clinical laboratory.
By function into: (1) Clinical Pathology (e.g., Hematology, Clinical Chemistry, Microbiology, Parasitology, etc., including Blood Banking and Toxicology/Therapeutic Drug Monitoring) and (2) Anatomic Pathology (e.g., Surgical pathology, Cytology, Autopsy, Forensic Pathology, Immunohistopathology).
Institutional character: (1) Hospital-based and (2) Non-hospital-based. Service capability: (1) Primary, (2) Secondary, and (3) Tertiary—each with specified minimum services.
Routine Hematology (e.g., CBC and related measurements), Routine Urinalysis, Routine Fecalysis, Blood Typing (hospital-based), and Quantitative platelet determination (hospital-based).
An approved permit to construct and design layout from the DOH’s Bureau of Health Facilities and Services (BHFS) must be secured prior to submission of an application (petition) to operate.
No. A clinical laboratory shall not be constructed unless plans are approved and a construction permit is issued by BHFS.
The DOH through the BHFS in the Health Regulation Cluster exercises regulatory functions under the rules.
A clinical laboratory must operate with a valid license issued by BHFS/CHD (compliance with minimum licensing requirements). The license is granted if the application is meritorious.
The license must be placed in a conspicuous location/area within the laboratory.
Letter of application to the Director of BHFS; Four (4) sets of site development plans and floor plans approved by an architect and/or engineer; DTI/SEC registration for private clinical laboratories.
Renewal must be filed within 90 days before expiry. If filed during the next two (2) months after expiry, a non-specified renewal plus a P1,000 penalty applies. If more than two months after expiry, there is a P100 fine for each month thereafter in addition to the P1,000 penalty.
The Director of BHFS/CHD or his duly authorized representative(s) may inspect and monitor. Clinical laboratories shall be inspected every two (2) years or as necessary.
The licensee must make available the premises and facilities and all pertinent records at reasonable time, and provide records for monitoring at any given time when required by authorized representatives.
The license is non-transferable. Transfer to another location requires written notice to CHD at least 15 days before actual transfer and requires reinspection. Any change affecting substantial conditions must be reported within 15 days for notation and approval; failure may cause revocation.
Suspension or revocation upon violation of R.A. 4688 or the rules. Examples: operating without a certified pathologist or registered medical technologist; changing ownership/location/head/personnel without informing BHFS/CHD; refusal to allow inspection; gross negligence; and acts/omissions detrimental to the public.
Upon conviction, imprisonment of not less than 1 month but not more than 1 year, and/or a fine of not less than P1,000 but not more than P5,000, at the court’s discretion. If the offender is a firm/corporation, the managing head and/or owners are liable.
A licensed physician certified by the Philippine Board of Pathology. In areas where pathologists are not available, a physician with three (3) months training on clinical laboratory medicine, quality control, and laboratory management may manage primary/secondary labs, certified by BHFS.
Laboratory records must be kept on file for at least one (1) year. Records of anatomic and forensic pathology must be kept permanently in the laboratory.