Clinical Laboratory Act 4688

• Clinical laboratory act is 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.
• Approved on June 18, 1966

  Signed by Ferdinand E. Marcos Sr.
• AO 201 s 1973 - revised rules and regulations governing the registration, operations and maintenance of CL in the Philippines
• AO 209 s 1976 - Amending section II subsection A of administrative order 201, s of 1973 concerning requirements for a clinical laboratory
• AO 49-B s 1988 - revised rules and regulations governing the registration, operation and maintenance of CL in the Philippines
• EO 102 s 1999 - redirecting the functions and operations of DOH
• AO 59 s 2001 - rules and regulations governing establishment, operation and maintenance of clinical laboratories in the Philippines
• AO 27 s 2007 - revised rules and regulations governing the licensure and regulation of CL in the Philippines
• Clinical Laboratory – a facility that is involved in the pre-analytical, 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.
• Applicant — refers to any natural juridical person, government instrumentalities/agencies, partnership, corporation or agency seeking a license to operate and maintain a clinical laboratory.
• Assessment Tool — the checklist which prescribes the minimum standards and requirements for licensure of clinical laboratory.
• Department of Health - License to Operate (DOH-LTO)

  — 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 - Permit to Construct (DOH-PTC)

  — 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
• External Quality Assessment Program (EQAP) — a program where participating CL are given unknown samples for analysis. The quality of performance of the CL shall be assessed through the closeness of its results to the pre-determined value or reference value

  generated by the participating CL through peer group analysis.
• Initial Application — 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.
• Mobile Clinical Laboratory (MCL) — 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.
• National External Quality Assessment Scheme (NEQAS)

  — an EQAP activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories.
• National Reference Laboratory (NRL) — 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.
• Research Institute for Tropical Medicine (RITM) - NRL for dengue, influenza, TB and other mycobacteria, malaria, and other parasites, bacterial enteric disease, measles, and other viral exanthems
• San Lazaro Hospital (SACCL) - NRL for HIV/ AIDS, hepatitis and sexually transmitted diseases
• East Avenue Medical Center - NRL for environmental and occupational health; toxicology and micronutrient assay
• National Kidney and Transplant Institute - NRL for hematology including immunohematology and immunopathology and anatomic pathology
• Philippine heart center - NRL for anatomic pathology of cardiac diseases
• Lung center of the Philippines - NRL for Clinical Chemistry
• Physician’s Office Laboratory (POL) — 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.
• Point of Care Testing (POCT) — 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.
• Satellite Clinical Laboratory (SCL) — 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.
• Referral Tests — refers to CL tests that are either sent- out or outsourced to other DOH-licensed CL with the same or higher service capability.
• • CLASSIFICATION OF OWNERSHIP
  • Government - operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city or municipal), any other political unit or any department, division, board or agency.
  • Private - privately owned, established, and operated with funds through donation, principal, investment or other means, by any individual, corporation, association or organization.
• CLASSIFICATION BY INSTITUTIONAL CHARACTER

  • Institution based - a laboratory located within the premises and operates as part of a DOH licensed health facility
  • Non-Institution based - a laboratory that operates independently and is not attached to any DOH licensed health facility