RA 4688: Clinical Laboratory Law Flashcards
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.
RA 4688
When was RA 4688 approved?
June 18, 1966
RA 4688 was signed by ________.
Pres. Ferdinand E. Marcos
Administrative and Executive Orders issued in relation to RA 4688
Revised Rules and Regulations Governing the Registration, Operations and Maintenance of Clinical Laboratories in the Philippines
- AO 201 s. 1973
- AO 49-B s. 1988
Administrative and Executive Orders issued in relation to RA 4688
Amending Section II Subsection A of Administrative Order No. 201, Series of 1973 Concerning Requirements for a Clinical Laboratory
AO 290 s. 1976
Administrative and Executive Orders issued in relation to RA 4688
Redirecting the Functions and Operations of the DOH
EO 102 s. 1999
Administrative and Executive Orders issued in relation to RA 4688
Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines
AO 59 s. 2001
Administrative and Executive Orders issued in relation to RA 4688
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
AO 27 s. 2007
Administrative and Executive Orders issued in relation to RA 4688
New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines
AO no. 2021-0037
Who signed AO 2021-0037?
Francisco Duque
DOH-LTO
Department of Health - License to Operate
DOH-PTC
Department of Health - Permit to Construct
HFSRB
Health Facilities and Services and Regulatory Bureau
CHD-RLED
Center for Health Development - Regulation, Licensing, and Enforcement Division
OLRS
Online Licensing and Regulatory System
OSSOLS
One-Stop Shop Online Licensing System
A facility that is involved in the preanalytical, analytical, and post-analytical procedures, where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of diseases.
Clinical Laboratory
It refers to any natural juridical person, government instrumentalities/agencies, partnership, corporation or agency seeking a license to operate and maintain a clinical laboratory.
Applicant
The checklist which prescribes the minimum standards and requirements for licensure of clinical laboratory.
Assessment Tool
A formal authorization issued by the DOH to an individual, partnership, corporation, association or any government agency/unit seeking to perform laboratory tests in compliance with the requirements prescribed in this order.
Department of Health – License to Operate (DOH-LTO)
A permit issued by DOH through HFSRB or Center for Health Development-Regulation, Licensing and Enforcement Division (CHD-RLED) to an applicant who will establish and operate a hospital or other health facility, upon compliance with required documents prior to the actual construction of the said facility.
Department of Health – Permit to Construct
(DOH-PTC)
A program where participating CL are given unknown samples for analysis.
External Quality Assessment Program (EQAP)
Refer to applications by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovations.
Initial Application
A laboratory testing unit capable of performing limited CL diagnostic procedures. It moves from one testing site to another, and it has a DOH-licensed CL as its main laboratory.
Mobile Clinical Laboratory (MCL)
An EQAP activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories.
National External Quality Assessment Scheme (NEQAS)
The highest level of laboratory in the country performing highly complex procedures, including confirmatory testing. It is the responsible entity for facilitating NEQAS to ensure compliance to quality standards for regulation and licensing of all laboratories in the Philippines.
National Reference Laboratory (NRL)
NRL for Dengue, Influenza, Tuberculosis and other Mycobacteria,
Malaria and other parasites, Bacterial enteric diseases, measles and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases; NRL for confirmatory testing of blood donors and blood units.
Research Institute for Tropical Medicine (RITM)
NRL for HIV/AIDS, Hepatitis and Sexually Transmitted Diseases
San Lazaro Hospital (SACCL)
NRL for Environmental and Occupational Health; Toxicology and Micronutrient Assay.
East Avenue Medical Center
NRL for Hematology including Immunohematology and Immunopathology and Anatomic Pathology
National Kidney and Transplant Institute
NRL Anatomic Pathology of Cardiac Diseases
Philippine Heart Center
NRL for Clinical Chemistry
Lung Center of the Philippines
It refers to a doctor’s office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor’s patients only, wherein no official results shall be issued. In this Order, POL within the premises of a DOH-regulated facility shall be under the supervision of the CL.
Physician’s Office Laboratory (POL)
It refers to diagnostic testing done at or near the site of patient care rather than in the CL. It may be in the emergency room, operating suites, wards, and ambulances.
Point of Care Testing (POCT)
It refers to CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability.
Referral Tests
It refers to an extension of the main CL located within the facility’s compound or premises. It shall have the same service capability as the main laboratory.
Satellite Clinical Laboratory (SCL)
It is required for the construction of new CL, renovation or expansion of existing CL, including change in ownership and transfer of location.
DOH-PTC
It is required for research and teaching laboratories.
Certificate of Registration (COR)
The DOH-LTO is valid for ________.
1 year
The COR for CL that is operated for reserach and teaching purposes shall be required to register with the DOH-HFSRB every _______.
3 years
