MTLBE - Clinical Laboratory Law

Republic Act 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.

June 18, 1966

Date of approval of the RA 4688

DOH Rationalization Plan of 2014

Through _______________, BHFS was changed to Health Facilities and Services Regulatory Bureau (HFSRB).

Administrative Order No. 2007-0027

Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

Clinical Laboratory

Facility where tests are done on specimens taken from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of diseases.

Ownership

Classification of Clinical Laboratories:

Government Clinical Laboratories and Private Clinical Laboratories

Function

Classification of Clinical Laboratories:

Clinical Pathology and Anatomic Pathology

Institutional Character

Classification of Clinical Laboratories:

Institution-based Clinical Laboratories and Freestanding Laboratories

Service Capability

Classification of Clinical Laboratories:

General Clinical Laboratories and Special Clinical Laboratories

Government Clinical Laboratory

Laboratory that is operated and maintained, partially or wholly, by the national or local government unit, and any political unit.

Private Clinical Laboratory

Laboratory that is owned, established and operated by an individual, corporation, association or organization.

Clinical Pathology

Laboratory that includes clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, etc.

Anatomic Pathology

Laboratory that includes surgical pathology, immunohistopathology, cytology, autopsy, forensic pathology and molecular pathology.

Institution-based Laboratory

Laboratory that operates with the premises and as part of an institution such as hospitals, medical clinic, school or any medical facility.

Free-standing Laboratory

Laboratory that is not a part of any institution.

Primary Laboratory

It refers to a clinical laboratory that offers the following minimum service capabilities:

Routine hematology

Quantitative platelet determination

Routine analysis

Routine fecalysis

Blood typing (hospital-based)

Secondary Laboratory

It refers to a clinical laboratory that offers the following minimum service capabilities:

Routine clinical chemistry

Quantitative platelet determination

Cross-matching (hospital-based)

Gram-staining (hospital-based)

KOH (hospital-based)

Tertiary Laboratory

It refers to a clinical laboratory that offers the following minimum service capabilities:

Special Chemistry

Special hematology, including coagulation procedures

Immunology

Microbiology

Limited Service Capability Laboratory

It is solely for institution-based and provides laboratory tests required for a particular service offered by the institution.

Special Clinical Laboratories

It offers highly specialized laboratory services that are not usually provided by general clinical laboratories, these services are:

Assisted reproduction technology

Molecular and cellular technology

Molecular biology

Molecular pathology

Forensic pathology

Anatomic pathology

Pre-analytical process

Handles specimen collection and handling

Analytical process

Encompasses testing procedures, instrumentation and equipment, reagent, quality control, personnel and facilities.

Post-analytical process

Deals with reporting the results and disposal of the waste products.

DOH Department Memorandum No. 148 s. 2003

Encompasses the Assessment Tool for Licensing a General Clinical Laboratory

10 square meters

Minimum technical working area of a Primary clinical Laboratory

20 square meters

Minimum technical working area of a Secondary clinical Laboratory

60 square meters

Minimum technical working area of a Tertiary clinical Laboratory

License to Operate (LTO)

A document issued by the DOH to an individual, agency, partnership or a corporation that operates a clinical laboratory upon compliance with the requirements set forth by the law.

1 year

Validity of License to Operate (LTO) issued by DOH-HFSRB to Clinical Laboratories

True

True or False

Government hospital laboratories performing 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.

True

True or False

The following are exempted from securing a license but are required to register under the provisions are:

Clinical laboratories for research and teaching purposes

Special clinical laboratories operating independent of a clinical laboratories

NRL physically independent from clinical laboratory

False

True or False

The LTO is issued in the name of the licensee and is transferrable.

100 kilometer radius

Mobile clinical laboratories are licensed as part of main clinical laboratories and are permitted to collect specimens only, they are allowed within ___________.

Physicians Office Laboratory

A laboratory within a physician's office where specimens can be tested immediately after collection.

Mobile Clinical Laboratory Testing Unit

A specialized facility that moves from one testing site to another or has a temporary testing location.

Remote Collection Permit for CL

A Mobile Clinical Laboratory Testing Unit shall secure a ___________ from the DOH and shall be secured at least seven (7) working days prior to schedule.

2 weeks

Remote Collection Permit for CL is valid for __________.

POCT actviity

A diagnostic test at or near the site of the patient care rather in the clinical laboratory.

Pathologist

A clinical laboratory must be headed and managed by a __________, certified by PBP.

10 minutes

A single laboratory test is estimated to be processed within ____________.

Manual Testing

50 tests/RMT/8 hours

Manual Testing

75 tests/RMT/12 hours

Automated Testing

100 tests/RMT/8 hours

Automated Testing

150 tests/RMT/12 hours

HFSRB or CHD of DOH

Application for License to Operate is filed with the ________________.

HFSRB or CHD of DOH

Who inspects and monitors clinical laboratories?

Notice of Violation

It is issued for non-compliant laboratories immediately after the monitoring of the laboratory.

NRL

National Reference Laboratory

NRL

A laboratory government hospital which has been designated by DOH to provide special functions and services for specific disease areas.

Philippine National Heart Center (PNHC)

NRL for Anatomic pathology and cardiac diseases

National Kidney and Transplant Institute (NKTI)

NRL for Hematology, Coagulation Tests, Immunohematology, Immunopathology, Renal Diseases and Automated Urinalysis

Lung Center of the Philippines (LCP)

NRL for Clinical chemistry, anatomic pathology for pulmonary diseases

San Lazaro Hospital STD/AIDS Cooperative Central Labortory

NRL for Screening and confirmatory tests for HIV/Syphilis, Hepatitis B and Hepatitis C

Research Institute for Tropical Medicine (RITM)

NRL for Dengue, Influenza, TB, Malaria and other parasitic diseases, Bacterial enteric diseases, Measles, and other exanthems, enterovirus, Antimicrobial Resistance, Confirmatory Testing for Blood Doors, Rabies, Japanese Encephalitis and other pathogens for meningitis

East Avenue Medical Center (EAMC)

NRL for Screening and confirmatory drug tests, water testing potability, analytical toxicology, methemoglobin, hemoglobin, and sulfhemoglobin.

External Quality Assessment Program (EQAP)

It is mandated that all clinical laboratories must participate with _________________ of the NRLs.

Certificate of Proficiency

DOH required clinical laboratories to have their __________ as a requirement or the renewal of their LTOs

RMT and Pathologist

Who are the persons authorized to sign an official laboratory report?

Laboratory Request

It is considered as a consultation of the requesting physician to the pathologist.

Laboratory Report

It is considered as an official consultation report of the pathologist to the requesting physician.

Permanently

Anatomic pathology results must be kept ____________.

1 year

Clinical laboratory results must be kept for ________.

HFSRB or CHD of DOH

Who will investigate the compliant lodged against clinical laboratories?

Outsourcing

It is allowed only when the laboratory test required is not part of the service capability of the referring laboratory and when it is a part of a contingency plan in case of equipment breakdown.

Secretary of Health

Who is tasked to enforce the provisions of the clinical laboratory law and its implementing rules?

1 month < x < 1 year

Violations of RA 4688 is punishable with imprisonment of ____________.

1 thousand pesos < x < 5 thousand pesos

Violations of RA 4688 is punishable with fine of ___________ .

10 days

Appeal for the decision of HFSRB/CHD to the Office of Health Secretary should be within ______ after the receipt of the decision notice.