ra 4688

What is the Republic Act number that regulates clinical laboratories in the Philippines?

RA 4688

When was RA 4688 approved?

June 18, 1966

How many sections does RA 4688 contain?

8 sections

Which law states that health services should be available and accessible to all people in the community?

RA 11223 (Universal Healthcare Act)

What is the main purpose of RA 4688?

To regulate the operation and maintenance of clinical laboratories and require their registration with the Department of Health

What is the requirement for operating a clinical laboratory according to Section 1 of RA 4688?

A clinical laboratory must register and secure a license annually from the Secretary of Health

Which government hospital laboratories are exempt from licensing under Section 1?

Those performing routine or minimum laboratory examinations as extensions of government regional or central laboratories

Who should head a clinical laboratory according to Section 2 of RA 4688?

A duly registered physician qualified in laboratory medicine and authorized by the Secretary of Health

What does AO 37 require regarding the head of a clinical laboratory?

A laboratory should be headed by a pathologist licensed by the Philippine Society of Pathologists

Which agency is responsible for enforcing RA 4688 according to Section 3?

The Secretary of Health through the Bureau of Research and Laboratories

What is the punishment for violating RA 4688 according to Section 4?

Imprisonment of 1 month to 1 year and/or a fine of P1,000 to P5,000

What does Section 5 of RA 4688 state about the invalidity of any part of the Act?

If any section is adjudged invalid, the judgment does not affect the remainder of the Act

How much was appropriated for implementing RA 4688 according to Section 6?

Fifty thousand pesos (P50,000)

What does Section 7 of RA 4688 state about conflicting laws?

All acts inconsistent with RA 4688 are repealed

When does RA 4688 take effect according to Section 8?

Upon its approval

To what types of laboratories does RA 4688 apply?

All laboratories that collect human samples for diagnosis, prevention, treatment, and management of diseases

What must all clinical laboratories comply with under RA 4688?

Minimum requirements set by the Act

Which government clinical laboratories are excluded from RA 4688?

Those doing malaria screening, AFB microscopy, STD tests, and cervical cancer screening

Which amendment excluded National Tuberculosis Reference Laboratories?

Amendment to AO 2007-0027

Why are special clinical laboratories like research labs and molecular labs excluded from RA 4688?

They are either governed by other laws or lack regulation

What administrative order revised the rules for clinical laboratories in 1973?

AO 201, series of 1973

What administrative order amended AO 201 in 1976?

AO 290, series of 1976

Which administrative order governs the licensure and regulation of clinical laboratories since 2007?

AO 27, series of 2007

What is the latest administrative order for clinical laboratories?

AO 2021-00037

What are the classifications of clinical laboratories based on function?

Clinical Pathology, Anatomic Pathology, Molecular Pathology

What are the classifications of clinical laboratories based on ownership?

Government, Private

What are the classifications of clinical laboratories based on institutional character?

Institution-based, Free-standing

What are the classifications of clinical laboratories based on What does Clinical Pathology focus on?

Clinical Chemistry, Immunohematology, Microbiology, Hematology, Immunology, Serology, Parasitology, Toxicology, Endocrinology

What does Anatomic Pathology focus on?

Histopathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology

What are the two main permits required to operate a clinical laboratory?

Permit to Construct (PTC) and License to Operate (LTO)

Which office processes applications for a clinical laboratory license?

HFSRB/CHD-RLED

What is the validity period of a DOH license to operate a clinical laboratory?

1 year

Which institution is the National Reference Laboratory for Hematology?

National Kidney and Transplant Institute (NKTI)

Which institution is the National Reference Laboratory for Microbiology and Parasitology?

Research Institute for Tropical Medicine (RITM)

Which institution is the National Reference Laboratory for Clinical Chemistry?

Lung Center of the Philippines (LCP)

Which institution is the National Reference Laboratory for Infectious Diseases?

San Lazaro Hospital (SLH)

Which institution is the National Reference Laboratory for Toxicology and Drug of Abuse Testing?

East Avenue Medical Center (EAMC)

What are the penalties for operating a clinical laboratory without a license?

Cease-and-Desist Order (CDO) and a penalty of P50,000

What is the penalty for a first offense of violating licensing regulations?

Stern warning

What is the penalty for a second offense of violating licensing regulations?

P30,000 fine

What is the penalty for a third offense of violating licensing regulations?

P50,000 fine

What happens after a fourth offense of violating licensing regulations?

Revocation of DOH license

What is the program where participating clinical laboratories are given unknown samples for analysis to assess their quality of performance?

External Quality Assessment Program (EQAP)

Which laboratory issues unknown samples to different participating clinical laboratories for quality assessment?

National Reference Laboratory (NRL)

What type of samples are given to participating clinical laboratories in the EQAP?

Unknown samples

How are EQAP samples supposed to be treated by clinical laboratories?

As ordinary human specimens for usual processing and examination

Why do clinical laboratories participate in EQAP?

To assess the closeness of their results to the predetermined reference value through peer group analysis

What is the laboratory testing unit capable of performing limited diagnostic procedures that moves from one testing site to another?

Mobile Clinical Laboratory (MCL)

What type of imaging is commonly done in a Mobile Clinical Laboratory (MCL)?

Diagnostic imaging, mobile x-ray

Where are samples collected by a Mobile Clinical Laboratory (MCL) processed?

At the main laboratory licensed by the DOH

What is the name of the traveling Medical Technologists in the US who collect biological samples from different locations?

Travel MedTech

What is the EQAP activity conducted by the National Reference Laboratories to assess laboratory performance and accuracy?

National External Quality Assessment Scheme (NEQAS)

What is the highest level of laboratory in the country that performs highly complex procedures, including confirmatory testing?

National Reference Laboratory (NRL)

Which laboratory ensures compliance with quality standards for the regulation and licensing of all laboratories in the Philippines?

National Reference Laboratory (NRL)

What type of testing is done when a screening test shows a positive result, requiring further verification?

Confirmatory testing

Where is a patient referred for confirmatory testing if they test positive for HIV?

San Lazaro Hospital

What is the type of laboratory found in a doctor’s office or clinic where clinical laboratory examinations are performed only for monitoring patients?

Physician’s Office Laboratory (POL)

What type of clinical laboratory does not issue official results?

Physician’s Office Laboratory (POL)

What is an example of a test commonly performed in a Physician’s Office Laboratory (POL)?

Glucose level test

What is the type of diagnostic testing done at or near the site of patient care rather than in a clinical laboratory?

Point of Care Testing (POCT)

What are two other names for Point of Care Testing (POCT)?

Bedside testing, Near-patient testing

Where is Point of Care Testing (POCT) commonly performed?

Emergency rooms, operating suites, wards, ambulances

What is an example of a Point of Care Testing (POCT) device?

Glucometer

What is the extension of the main clinical laboratory located within the facility’s compound or premises?

Satellite Clinical Laboratory (SCL)

What must a Satellite Clinical Laboratory (SCL) have in common with its main laboratory?

The same service capability

What is the maximum allowable distance between a Satellite Clinical Laboratory (SCL) and the main laboratory?

100 meters

What happens if a Satellite Clinical Laboratory (SCL) exceeds the 100-meter limit from the main laboratory?

It is considered a violation

What are clinical laboratory tests that are sent out or outsourced to other DOH-licensed laboratories with the same or higher service capability?

Referral tests

Why are referral tests outsourced to other clinical laboratories?

Because they require specialized testing not performed in the referring laboratory

Who releases the results of referral tests?

The referral laboratory that performed the test

What administrative order first established the revised rules and regulations governing clinical laboratories in the Philippines?

Administrative Order (AO) 201, series of 1973

Which administrative order amended AO 201 to include additional requirements for clinical laboratories?

Administrative Order (AO) 290, series of 1976

Which administrative order revised the rules and regulations governing clinical laboratories in 1988?

Administrative Order (AO) 49-B, series of 1988

Which administrative order redirected the functions and operations of the Department of Health (DOH) in 1999?

Executive Order 102, series of 1999

Which administrative order set the rules and regulations for establishing, operating, and maintaining clinical laboratories in 2001?

Administrative Order (AO) 59, series of 2001

Which administrative order revised the licensure and regulation of clinical laboratories in 2007?

Administrative Order (AO) 27, series of 2007

What is the latest administrative order aligning laboratory procedures with new healthcare regulations?

Administrative Order (AO) 2021-00037

What is the purpose of AO 2021-00037?

To align laboratory procedures with the requirements of AO 2020-0047 and revise technical standards for licensing clinical laboratories

Which law is considered in the revisions of AO 2021-00037 to guarantee access to quality and affordable health services?

Republic Act 11223 (Universal Health Care Act)

Why was AO 2021-00037 introduced?

To update laboratory classifications, improve technical standards, and address advancements in healthcare technology

What major event highlighted the need for revisions in laboratory classification and regulation?

The COVID-19 pandemic

What laboratory type was added due to the COVID-19 pandemic?

Molecular testing laboratories

How did AO 2021-00037 change the classification of laboratories according to function?

It expanded laboratory types from two (2) to three (3) classifications

What are the two primary permits required to establish a clinical laboratory?

Permit to Construct (PTC) and License to Operate (LTO)

What must an individual, firm, or corporation submit to establish and operate a clinical laboratory?

An accomplished application form to the Health Facilities and Services Regulatory Bureau (HFSRB) or Center for Health Development - Regulatory, Licensing, and Enforcement Division (CHD-RLED)

Where can an application for a clinical laboratory License to Operate (LTO) be submitted?

Manually or through the DOH Online Licensing and Regulatory System (OLRS)

What are the requirements for applying for a License to Operate (LTO)?

Application form, notarized acknowledgment, proof of ownership, self-assessment tool, health facility geographic form, and official receipt of payment

How long is a DOH License to Operate (LTO) valid?

One (1) year

What is required for a clinical laboratory to renew its license?

Compliance with licensing requirements and participation in External Quality Assurance Programs (EQAP)

Which agency monitors clinical laboratory compliance with licensing requirements?

The director of the Health Facilities and Services Regulatory Bureau (HFSRB) or CHD-RLED

Where must the License to Operate (LTO) be displayed?

In an area visible to the public at all times (e.g., reception area)

Is a License to Operate (LTO) transferable?

No, a new license must be obtained for changes in ownership or transfer of location

What happens if a clinical laboratory operates without a License to Operate (LTO)?

It will receive a Cease-and-Desist Order (CDO) and a fine of P50,000

What penalties apply for operating a clinical laboratory without a Permit to Construct (PTC) or License to Operate (LTO)?

Cease-and-Desist Order (CDO) and a P50,000 fine

How often must a clinical laboratory be inspected?

Every two (2) years

What must all clinical laboratories have as part of quality assurance?

An Internal Quality Control Program and participation in External Quality Assurance Programs (EQAP)

What is required for satisfactory performance in External Quality Assurance Programs (EQAP)?

At least a satisfactory rating from the National Reference Laboratory (NRL)

What happens if a clinical laboratory refuses to participate in an External Quality Assurance Program (EQAP)?

It may face suspension or revocation of its License to Operate (LTO)

Which administrative order requires all clinical laboratories to have a quality assurance program?

Department Memorandum No. 2009-0086

What are the two components of a clinical laboratory's quality assurance program?

Internal Quality Control Program and External Quality Assurance Program