MT LAWS FINALS

• RA 4688: Clinical Laboratory Act of 1966


  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, FOR OTHER PURPOSES
• Date of Effectivity of the Clinical Laboratory Act of 1966


  June 18, 1966
• Department of Health


  • Responsible for registering clinical laboratories and granting or renewing licenses for their operation and maintenance
• Licensed physicians


  • Only licensed physicians who are duly qualified in laboratory medicine and authorized by the Secretary of Health can be in charge of a registered clinical laboratory
• Bureau of Research & Laboratories

  • Tasked with enforcing the provision of the act under the authority of the Secretary of Health
• Court of Competent Jurisdiction

  • Responsible for determining the validity of the Act and its provisions
• Registration Requirement


  • All clinical laboratories in the Philippines must register with the Department of Health and obtain an annual license
• Exemption for Government Hospital Laboratories

  • Government hospital laboratories that perform routine or minimum laboratory examination are exempt from the registration requirement if their services are extensions of government regional or central laboratories
• Authorized Physicians


  • Only licensed physicians who are duly qualified in laboratory medicine and authorized by the Secretary of Health can be in charge of a registered clinical laboratory. This authorization needs to be renewed annually.
• Administration and Supervision


  • The laboratory must be under the administration, direction, and supervision of an authorized physician
• Enforcement


  • The Bureau of Research and Laboratories, under the authority of the Secretary of Health, is responsible for enforcing the provisions of this Act
• A.O. NO. 0027 S.2007: DOH Administrative Order Number 2007-0027

  REVISED RULES AND REGULATION GOVERNING THE LICENSURE AND REGULATION OF CLINICAL LABORATORIES IN THE PHILIPPINES
• Date of Effectivity of DOH Administrative Order Number 2007-0027


  August 22, 2007
• Applicant


  A natural/ juridical person who intends to operate a clinical laboratory
• BHFS


  Acronym for Bureau of Health Facilities and Services
• CHD


  Acronym for Center for Health Development
• Clinical Laboratory


  A facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the not limited to, the following disciplines: Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Chemistry, Hematology, Histopathology, Cytology, Toxicology, Endocrinology, Molecular biology. Other functions are to provide consultative interpretation of results and advice on further appropriate investigation.
• Facilities involved in pre-analytical processes


  Such as collection, handling or preparation of specimens or act as a mailing/distribution center such as in a laboratory.
• Total testing process


  Includes pre-analytical procedure, analytical procedure, and post-analytical procedure.
• DOH


  Acronym for Department of Health
• EQAP


  Acronym for External Quality Assessment Program. A program where participating laboratories are given unknown samples for analysis to assess their quality performance.
• Inspection Tool


  The checklist used by the regulatory officers during inspection visit/s to evaluate compliance of a clinical laboratory to the minimum standards and technical requirements
• License


  The document issued by the DOH to an individual, agency, partnership, or corporation that operates a clinical laboratory upon compliance with the requirements set forth in this Order
• LTO


  Acronym for License to Operate. It also refers to the license.
• Mobile Clinical Laboratory


  A laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location. It shall have a base laboratory.
• Monitoring Examinations


  Tests done in series on patients as a guide for treatment or follow up of their condition
• NRL


  Acronym for National Reference Laboratory. A laboratory in a government hospital which had been designated by the DOH to provide special functions and services for specific roles.
• POL


  Acronym for Physician's Office Laboratory. An individual doctor's office/clinic wherein laboratory examinations are performed.
• POCT


  Acronym for Point of Care Testing. Diagnostic testing at or near the site of the patient care rather than in the clinical laboratory, including bedside testing, outpatient and home care.
• Routine Tests


  The basic, commonly requested tests in the laboratory. The results of which are not required to be released immediately upon completion.
• Satellite Testing Site


  Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory.
• STAT Tests


  Tests done on urgent cases, the results of which shall be released immediately within 1 hour after the procedure. STAT is an abbreviation for sta'tim which mean immediately.
• Classification of Clinical Laboratories by Ownership

  • Government - operated and maintained, partially or wholly, by the national government, a local government unit, any other political unit or any department, division, board or agency thereof
  • Private - owned, established and operated by any individual, corporation, association or organization
• Classification of Clinical Laboratories by Function

  • Clinical Pathology - includes Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring and other similar disciplines
  • Anatomic Pathology - includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology
• Classification of Clinical Laboratories by Institutional Character


  • Institution Based - a laboratory that operates within the premises and as part of an institution, such as but not limited to: hospital, medical clinic, school, medical facility for overseas and seafarers, birthing home, psychiatric facility, drug rehabilitation center
  • Free-standing - a laboratory that does not form part of any other institution
• Classification of Clinical Laboratories by Service Capability

  • General Clinical Laboratory: Primary Category, Secondary Category, Tertiary Category, Limited Service Capability
  • Special Clinical Laboratory - a laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory
• National Reference Laboratories (NRLs) Designated by the DOH

  • East Avenue Medical Center (EAMC) - Environmental and occupational health, Toxicology and micronutrient assay
  • Lung Center of the Philippines (LCP) - Anatomic Pathology and Biochemistry, Conduction for Clinical Chemistry
  • National Kidney and Transplant Institute (NKTI) - Hematology including immunohematology
  • Philippine Heart Center (PHC) - Pathology for cardiac disease
  • Research Institute for Tropical Medicine (RITM) - 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, Confirmatory testing of blood donor and blood units
  • San Lazaro Hospital (SLH) - HIV/AIDS, Sexually transmitted diseases, Hepatitis
• Satellite Testing Site


  • Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory but performed outside the physical confines of the laboratory
• Mobile Clinic Laboratory


  • A laboratory testing unit that moves from testing site to another or has a temporary testing location but shall have a base laboratory. Shall be licensed as part of the main clinical laboratory and is permitted to collect specimens only. Shall be allowed to operate only within 100 radius from its main laboratory.
• License To Operate (LTO)


  • Issued in the name of the licensee and is NON-TRANSFERABLE. 2. Issued ONLY to laboratories that comply with the standards set forth by the Bureau of Health Facilities and Services (BHFS). 3. NOT valid for any location other than that which is stipulated therein. 4. VALIDITY: one (1) year and expires on the date set forth by the Center for Health Development (CHD). 5. Must be displayed at all times in a CONSPICUOUS place within the laboratory.