MTLB

• Establishment of RA 4688 (Clinical Laboratory Act of 1966)


  June 18, 1966
• Classification of Laboratories by Function: Clinical Pathology and Anatomic Pathology
• Staffing requirements for Clinical Laboratories

  1. The Clinical Laboratory shall be managed by a licensed physician certified by the Philippine Board of Pathology

  2. In areas without Pathologists, a physician with specific training may manage primary/secondary category clinical laboratories
• Rules and regulations for laboratory diagnostic procedures

  • A.O. No. 14 – A s.1997
• Classification of Laboratories by Service Capability: Primary, Secondary, Tertiary
• Rules and regulations for medical technology schools, colleges, and universities

  • A.O. No. 274 s.1976
  • A.O. No. 21 s. 1979
  • A.O. No. 118 – B s. 1992
• RA 4688


  • An act regulating the operation and maintenance of clinical laboratories, requiring registration with the Department of Health, and providing penalties for violations
• Classification of Laboratories by Institutional Character: Hospital-based and Non-hospital based
• National policies and regulations

  • A.O. No. 19A s. 1998
  • A.O. No. 7 – C s. 2001
  • A.O. No. 59 s. 2001
  • A.O. No. 2005 – 2006
  • A.O. No. 2007 – 0027
• Technical Standards and Minimum Requirements for Clinical Laboratories

  • Staffing
  • Physical Facilities
  • Equipment/Instruments
  • Glasswares/reagents/supplies
  • Waste Management
  • Quality Control Program
  • Reporting
  • Recording
  • Laboratory Fees
• For hospital-based clinical laboratories, there shall be at least one registered medical technologist per shift to cover the laboratory operation
• Equipment/Instruments requirements

  • Provisions for sufficient number and types of appropriate equipment/instruments
  • Equipment complying with safety requirements
  • Availability of necessary equipment for other laboratory examinations
• Internal Quality Control Program

  1. Documented, continuous competency assessment program for all laboratory personnel

  2. Program for appropriate and standard laboratory methods, reagents & supplies, and equipment

  3. Program for proper maintenance and monitoring of all equipment

  4. Use of quality control reference materials

  5. Daily control purchased by the laboratory
• A physician with three (3) months training on clinical laboratory medicine, quality control, and laboratory management may manage primary/secondary category clinical laboratories in areas where Pathologists are not available
• Waste Management requirements

  • Provisions for adequate and efficient waste disposal following guidelines of the Department of Health and the local government
• All laboratory requests shall be constructed as consultation between the requesting physician and the Pathologist of the laboratory, and laboratory results shall be released accordingly
• There shall be a system of accurate recording to ensure quality results
• No person in the clinical laboratory shall issue a report, orally or in writing, whole or portions thereof without a directive from the Pathologist or his authorized associate to the requesting physician or his authorized representative except in emergency cases when the results may be released as authorized by the Pathologist
• Quality Control Program


  1. Functional Quality Assurance Program

  2. Check accuracy and reliability

  3. Inspection by DOH every year

  4. Designed to detect, reduce, and correct deficiencies in the laboratory's internal analytical process prior to releasing patient results to improve result quality
• Physical Facilities requirements

  • Well-ventilated, adequately lighted, clean, and safe
  • Sufficient working space to accommodate activities and allow for smooth work flow
  • Adequate water supply
• The BHFS shall certify such training
• All laboratory reports on various examinations of specimens shall bear the name of the registered medical technologists and the Pathologist and be duly signed by both
• External Quality Control Program

  1. Participation in an External Quality Assurance Program by designated National Reference Laboratories and/or other recognized reference laboratories

  2. Satisfactory performance rating by a National Reference Laboratory as a criterion for license renewal
• Medical Technicians cannot sign the report (computerized); medical technologist or physician
• There shall be an adequate and effective system of recording requests
• Glasswares/Reagents/Supplies requirements


  • Provision of adequate and appropriate glassware, reagents, and supplies necessary for services
• The laboratory and professional fees to be charged for laboratory examination shall be at the prevailing rates
• Professional services rendered to the patient in the performance of special procedures or examinations shall be charged separately and not included in the laboratory fee/s
• The rates for laboratory examination shall be within the range of the usual fees prevailing at the time and the particular place, taking into consideration the cost of testing and quality control of various laboratory procedures
• Recording requirements

  • There shall be a system of accurate recording to ensure quality results
  • There shall be an adequate and effective system of recording requests and reports of all specimens submitted and examined
  • There shall be provisions for filing, storage and accession of all reports
  • All laboratory records shall be kept on file for at least one (1) year
  • Records of anatomic and forensic pathology shall be kept permanently in the laboratory
• NBI
• Clinical Pathology


  Medical specialty concerned with the diagnosis of disease based on the laboratory analysis of body fluids such as blood and urine
• Pathologist is the head of the laboratory
• Training of Physician: Bureau of Health Facilities and Service
• Research Institute for Tropical Medicine (RITM)
• SHIFT: 6:00 to 2:00 (morning), 2:00 to 10:00 (PM), 10:00 to 6:00 (night)
• Classification of Clinical Laboratories by Function

  • Clinical Pathology
  • Anatomic Pathology
• Classification of Clinical Laboratories
• East Avenue Medical Center (EAMC)
• Lung Center of the Philippines