RA 4688: THE CLINICAL LABORATORY LAW

RA 4688

Law that regulates the operation and maintenance of clinical laboratories

1966

Year RA 4688 was enacted.

Department of Health (DOH)

Main government agency responsible for regulating clinical laboratories under RA 4688.

Bureau of Research and Laboratories (BRL)

Bureau created in 1958 that initially regulated clinical laboratories.

Bureau of Health Facilities and Services (BHFS)

Bureau that replaced BRL in 2001.

Health Facilities and Services Regulatory Bureau (HFSRB)

Current name of the regulatory bureau for health facilities under DOH.

License to Operate (LTO)

Document issued by DOH to authorize the operation of clinical laboratories.

One year

Validity period of a clinical laboratory’s LTO.

Permit required by mobile clinical laboratories to collect specimens remotely.

Remote Collection Permit for Clinical Laboratory (RCP-CL)

Government clinical laboratory

Type of clinical laboratory based on ownership that is funded by the government

Private clinical laboratory

Type of clinical laboratory that is privately owned and operated.

General clinical laboratory

Category of laboratory that provides basic and routine lab exams.

Special clinical laboratory

Type of lab offering highly specialized laboratory services.

To safeguard public health by ensuring accuracy and precision of lab results

Primary purpose of regulating clinical laboratories under RA 4688.

Physician’s Office Laboratory (POL)

Type of testing facility located in a physician’s clinic.

Monitoring of the physician’s own patients

Testing activity allowed in a POL without requiring an LTO.

Pathologist

Supervisory authority required to head all clinical laboratories.

Philippine Board of Pathology

Board that certifies pathologists in the Philippines.

Pre-analytical, Analytical, Post-analytical

Three phases of the laboratory testing process.

60 square meters

Minimum area required for a tertiary clinical laboratory

20 square meters

Minimum area required for a secondary clinical laboratory.

10 square meters

Minimum area required for a primary clinical laboratory.

Research Institute for Tropical Medicine (RITM)

Government hospital where the NRL for infectious diseases is located.

SACCL / San Lazaro Hospital

Government hospital designated as NRL for HIV, syphilis, and hepatitis.

National Kidney and Transplant Institute (NKTI)

NRL for hematology, immunopathology, and renal diseases.

Philippine National Heart Center

NRL designated for cardiac diseases.

East Avenue Medical Center

NRL for drug testing and toxicology.

External Quality Assessment Program (EQAP)

Rule requiring all clinical laboratories to join a quality assessment program.

DOH Department Order No. 2018-0471

Department Order requiring EQAP participation for license renewal.

Outsourcing

Process of sending a specimen to another lab for testing.

DOH Circular No. 2018-0130

DOH circular governing outsourcing due to equipment breakdown.

Registration with HFSRB or CHD

What must be secured by special, NRL, research, and teaching labs for registration.

One-Stop-Shop Licensure System for Hospitals

Licensing system used for hospital-based clinical laboratories.

October 1 to November 30

Time period for renewal of LTO for non-hospital-based labs.

Memorandum of Agreement (MOA

Document required when referring laboratory tests to external labs.

Name of the external laboratory (not the referring lab)

Label of result form when a lab outsources a test.

Result transferring

Prohibited practice of transferring external lab results to the referring lab’s form.

Punishment under RA 4688 for violations.

Imprisonment (1 month to 1 year), Fine (₱1,000 to ₱5,000), or both

Mobile clinical laboratory

Type of laboratory facility that moves from site to site.

Laboratory report

Official report issued by a pathologist after a lab examination..

Laboratory request

Request document submitted by a physician for lab testing.

Non-renewal of license

Penalty for refusal to participate in EQAP.

HFSRB or Center for Health

Agency that inspects and monitors clinical laboratories.

Licensed physician with training in laboratory medicine or 2 years residency in clinical pathology

Type of physician allowed to manage a lab in absence of a pathologist.

LTO is valid only for specified location and cannot be used elsewhere

Rule that clinical lab LTO is non-transferable and tied to the facility location.

Anatomic pathology reports

Standard laboratory record that must be kept permanently.

RA 4688

Clinical laboratory act that penalizes deviation from standard testing procedures.

Must be specifically indicated in the LTO

Requirement for reporting test results for HIV or water analysis.

Home service blood collection upon doctor’s request within 1-hour travel time

Activity exempted from securing an RCP-CL.

Office of the Health Secretary

Appeals body for decisions made by HFSRB/CHD.