Requirements to operate a private clinical laboratory

Dear PAO,

My college friend has been operating a private diagnostic laboratory in their province for years. He told me recently about his concern involving another entrepreneur in their area who is planning to construct and operate a similar laboratory but without the necessary medical licenses since they claim to have already a mayor’s permit from a different business venture. My friend is worried that aside from having a competitor, the operation of a new unlicensed clinical laboratory may harm the public. Because of this, we want to know if a diagnostic laboratory can operate with just a mayor’s permit. This seems unfair to my friend, who complied with the different requirements for the operation of his diagnostic laboratory. I hope your office can advise us on this.

Dricus

Dear Dricus,

For your information, Republic Act 4688, otherwise known as “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,” was enacted to regulate the operation of clinical laboratories.

Related to your concern, this law explicitly states that:

“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… (Emphasis supplied)

The Department of Health (DoH) provides specific guidelines through its Administrative Order 2021-0037, dated June 11, 2021, which contains new rules and regulations governing the licensing of diagnostic clinical laboratories in the Philippines to ensure accountability. Among those included in the general guidelines of this administrative order is the explicit requirement that all clinical laboratories shall secure a License to Operate from the DoH (DoH-LTO). An application for the required DoH-LTO is composed of several documentary requirements, including a filled-out application form, notarized acknowledgment, proof of ownership and a health facility geographic form, among others. (Sec. VII(B), AO-2021-0037)

In addition to this, the cited administrative order specifies in its procedural guidelines that the construction or renovation of a clinical laboratory shall require a prior Permit to Construct from the DoH. (Sec. VII(B), AO-2021-0037) Submission of the application for the necessary permits and licenses shall then be subject to review and a conduct of on-site assessment by the DoH to determine full compliance with the standard and technical requirements. (Sec. VII (B.3), AO-2021-0037)

It can be seen from the guidelines provided in the cited administrative order that specific permits and licenses from the DoH are required before the construction and operation of a clinical laboratory.

Any person who operates a clinical laboratory without the necessary DoH-PTC and corresponding DoH-LTO shall be issued a Cease-and-Desist Order (CDO) and shall pay an administrative penalty of P50,000. (Sec. IX(E), AO-2021-0037) This penalty is in addition to the imposable penalty provided in Section 4 of Republic Act 4688, which carries a punishment of imprisonment, fine or both, at the discretion of the court.

Considering this, a mayor’s permit alone is not enough to legally operate a clinical laboratory. The operation of an unlicensed clinical laboratory should be reported to the monitoring and enforcement office of the DoH in your region.

We hope that we were able to answer your queries. This advice is based solely on the facts you have narrated and our appreciation of the same. Our opinion may vary when other facts are changed or elaborated on.

Editor’s note: Dear PAO is a daily column of the Public Attorney’s Office. Questions for Chief Acosta may be sent to [email protected]