Managing clinical laboratories in the Philippines is legally guided by Republic Act 4688 or the Clinical Laboratory Law of 1966 with several Administrative Orders (AO) and Executive Orders (EO) to supplement its implementation.
The legal history of RA 4688 started on June 18, 1966 when it was approved and ratified by the president of the Philippines. The law then developed with the aid of several Administrative and Executive Orders that were issued for supplementation and regulatory guidelines in support of RA 4688.
The following Administrative and Executive Orders were issued in relation to RA 4688:
The legal history of RA 4688 started on June 18, 1966 when it was approved and ratified by the president of the Philippines. The law then developed with the aid of several Administrative and Executive Orders that were issued for supplementation and regulatory guidelines in support of RA 4688.
The following Administrative and Executive Orders were issued in relation to RA 4688:
- AO 201 s. 1973
- AO 290 s. 1976
- AO 52 s. 1983
- AO 49-B s. 1988
- EO 102 s. 1999 (Redirecting the Functions and Operations of the DOH)
- AO 59 s. 2001 (Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines)
- AO 27 s. 2007 (Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines)
REPUBLIC ACT NO. 4688
REPUBLIC ACT NO. 4688 - 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
Section 1. Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of the Secretary of Health: provided, that government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories.
Sec. 2. It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually.
No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction and supervision of an authorized physician, as provided for in the preceding paragraph.
Sec. 3. The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions.
Sec. 4. Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court.
Sec. 5. If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof.
Sec. 6. The sum of fifty thousand pesos, or so mush thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act.
Sec. 7. All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.
Sec. 8. This Act shall take effect upon its approval.
Approved: June 18, 1966