Lesson 8 : Nature of the Clinical Laboratory

• The Clinical Laboratory - provide accurate and reliable information to medical doctors for the diagnosis, prognosis, treatment, and management of diseases
• Classifications of Clinical Laboratory (According to FUNCTION)

  Clinical Pathology

  • it is concerned with the diagnosis and treatment of diseases performed through laboratory testing of blood and other body fluids

  Anatomic Pathology

  • it is concerned with the diagnosis of diseases through microscopic examination of tissues and organs
• Classification of Clinical Laboratory (According to INSTITUTIONAL CHARACTERISTICS)

  Institution Based

  • operates within the premises or part of an institution (e.g., hospital)

  Free-standing

  • not part of an established institution (e.g., free-standing out-patient clinical laboratory)
• Classifications of Clinical Laboratory (According to OWNERSHIP)

  Government-Owned

  • owned, wholly or partially by national or LGUs

  Privately-Owned

  • owned, established, and operated by an individual , corporation, institution, association or organization
• Classification of Clinical Laboratory (According to SERVICE CAPABILITY)

  Primary Category

  • licensed to perform basic, routine laboratory testing
  • microscope, centrifuge, hemocrit centrifuge
  • 10 sqm
• Classification of Clinical Laboratory (According to SERVICE CAPABILITY)

  Secondary Category

  • licensed to perform laboratory tests being done by the primary category
  • + routine clinical chemistry tests
  • 20 sqm
• Classification of Clinical Laboratory (According to SERVICE CAPABILITY)

  Tertiary Category

  • licensed to perform laboratory tests being done by secondary category laboratory
  • + immunology and serology, microbiology, bacteriology, and mycology, special clinical chemistry and hematology, immunohematology and blood banking
  • 60 sqm
  • equipment present in secondary category + automated chemistry analyzer, biosafety cabinet class II, serofuge
• Classification of Clinical Laboratory (According to SERVICE CAPABILITY)

  National Reference Laboratory

  • laboratory in a government hospital designates by the DOH to provide special diagnostic functions and services for certain diseases
  • referral services, assistance for research activities, confirmatory testing provisions
  • implementation of External Quality Assurance Programs (EQAP)
• R.A 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
• R.A 4688

  Section 1

  • any person, firm, or corporation, operating and maintaining a clinical laboratory, shall register and secure license annually at the Office of the Secretary of Health
• R.A 4688

  Section 2

  • professionally in-charge should be a licensed physician, qualified in laboratory medicine and authorized by the Secretary of Health, such authorization should be renewed annually
  • no license shall be granted nor renewed if not followed
• R.A 4688

  Section 3

  • the Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly encorcing the provisions of this act
• R.A 4688

  Section 4

  • if violates (R.A 4688 - secs 1,2,3) shall be punished with imprisonment for not less than one month but nit more than one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court
• A.O 459 Series of 2001

  • rules and regulation governing the establishment, operation, and maintenance of clinical laboratories in the Philippines
• A.O No. 59 Series of 2001

  Section 1 : Title

  • this A.O shall be known as the “Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines”
• A.O No. 59 Series of 2001

  Section 2 : Authority

  • this A.O are issued to implement R.A 4688 : Clinical Laboratory Law consistent with E.O 102 Series of 1999 : Redirecting the Functions and Operations of the Department of Health. The Department of Health (DOH), through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions under these rules and regulations
• A.O No. 59 Series of 2001

  Section 3 : Purpose

  • promulgated to protect and promote the health of the people by ensuring availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through compliance with quality standards
• A.O No. 59 Series of 2001

  Section 4 : Scope

  1. applied to all entities performing the activities and functions of clinical laboratories

  2. these regulations do not include government laboratories doing laboratory examinations limited to acid fast bacilli microscopy, malaria screening, and cervical cancer screening, provided their services are declared as extension of a licensed government clinical laboratory
• A.O No. 59 Series of 2001

  Section 5 : Classification of Laboratories

  1. Classification by FUNCTION

  • Clinical Pathology
  • Anatomic Pathology

  2. Classification by INSTITUTIONAL CHARACTER

  • Hospital-based Laboratory
  • Non-Hospital-based Laboratory

  3. Classification by by SERVICE CAPABILITY

  • Primary
  • Secondary
  • Tertiary
• A.O No. 59 Series of 2001

  Section 6 : Policies

  1. approved permit to construct design lay-out of a clinical laboratory shall be secured form the BHFS prior to submission of an application for a Petition to Operate

  2. no clinical laboratory shall be constructed without the permission from BHFS
• A.O No. 59 Series of 2001

  3. clinical laboratory shall operate with a valid license issued by BHFS/CHD

  4. clinical laboratory shall be organized and managed to provide effective and efficient laboratory services

  5. clinical laboratory shall provide adequate and appropriate safety practices for its personnel and clientele
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  1. application for permit to construct

  • letter of application to the director of BHFS
  • four sets of sited developmental plans and floor plans approved by an architect and/or engineer
  • DTI/SEC registration (for private clinical laboratory)
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  2. Application for New License

  • duly notarized application form “Petition to Establish, Operate, and Maintain a Clinical Laboratory“, shall be filed by the owner of his duly authorized representative at the BHFS
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  3. Application for Renewal of License

  • a duly notarized application form “Application for Renewal of License to Establish, Operate, and Maintain a Clinical Laboratory”, shall be filed by the owner or his duly authorized representative at the respective CHD
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  3. Application for Renewal License

  • application for renewal of license shall be filled within 90 days before the expiry date of the license described as follows
  • NCR - January to March
  • 1,2,3, & CAR - February to April
  • 4,5,&6 - March to May
  • 7,8,&9 - April to June
  • 10,11,12,CARAGA & BARRM - May to July
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  4. Permit and License Fees

  non-refundable fee ;

  • license fee shall be charged for application for permit to construct, and for license to operate a government and private clinical laboratory
  • shall be charged for application for renewal of license to operate
  • shall be paid to the cashier of the BHFS/CHD
  • shall follow the current prescribed schedule of all fees of the DOH
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  5. Penalties

  • penalty of one thousand pesos for late renewal shall be charged in addition to the renewal fee for all categories if the application is filled during the next two months after expiry date
  • application received more than two (2) months after expiry date shall be fined one hundred pesos for each month thereafter in the addition to the 1,000 penalty
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  6. Inspection

  • each license shall make available to the director of the BHFS/CHD
  • clinical laboratories shall be inspected every two years as a necessary
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  7. Monitoring

  • clinical laboratories shall be monitored regularly and records shall be made available
  • the director or authorized representative of the BHFS/CHD shall be allowed to monitor the clinical laboratory at any given time
  • clinical laboratories shall make available to the director of the BHFS or his duly authorized representatives record for monitoring
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  8. Issuance of License

  • the license shall be issued by the director of the CHD or his authorized representative, if the application is found to be meritorious
• A.O No. 59 Series of 2001

  Section 7 : Requirements and Procedures for Application of Permit to Construct and License to Operate

  9. Terms and Condition of License

  license ;

  • granted upon compliance with licensing requirements
  • is non-transferrable
  • owner or authorized representative of any clinical laboratory desiring to transfer a licensed clinical laboratory to another location shall inform the CHD in writing at least 15 days before actual transfer
• A.O No. 59 Series of 2001

  Section 8 : Violations

  • the license to operate a clinical laboratory shall be suspended or revoked by the Secretary of Health upon violation of R.A 4688 or the Rules and Regulations issued in pursuance thereto
• A.O No. 59 Series of 2001

  Section 8 : Violations

  The following acts committed by the Owner, President, Managers, Board of Trustees/Director, Pathologist or its personnel are considered violations

  • operation of clinical laboratory without a licensed pathologist and medical technologist
  • change of ownership, location, head of laboratory or personnel withoutb informing the BFHS and/or the CHD
  • refusal to allow inspection of the clinical laboratory by the person authorized by the BHFS during reasonable hours
  • gross negligence
  • any act or omission detrimental to public
• A.O No. 59 Series of 2001

  Section 8 : Violations

  • the provincial, city, and municipal health officers are authorized to report to the CHD and BFHS the existence of unlicensed clinical laboratories
• A.O No. 59 Series of 2001

  Section 9 : Investigation of Charges or Complaints

  The BFHS and CHD or his duly authorized representative shall investigate the complaint and verify if the laboratory concerned or any of its personnel is guilty of the charges

  • if any person found violating the provision of R.A 4688, they shall be suspended, cancel or revoke for a detemined period of time the license, as well as the authority of the offending person, without prejudice to taking the case to judicial authority of criminal action
• A.O No. 59 Series of 2001

  Section 9 : Investigation of Charges or Complaints

  The BFHS and CHD or his duly authorized representative shall investigate the complaint and verify if the laboratory concerned or any of its personnel is guilty of the charges

  • violated persons shall upon convicted subject to imprisonment for not less than 1 month but not more than 1 year or a fine of not less than 1,000 pesos and not more than 5,000 pesos
• A.O No. 59 Series of 2001

  Section 9 : Investigation of Charges or Complaints

  The BFHS and CHD or his duly authorized representative shall investigate the complaint and verify if the laboratory concerned or any of its personnel is guilty of the charges

  • any clinical laboratory operating without a valid license or whose license has been revoked/cancelled shall be summarily closed down
  • the closure order issued by the DOH shall not be rendered ineffective by any restraining order and injuction order issued by any court, tribunal, agency or instrumentalities
• A.O No. 59 Series of 2001

  Section 10 : Modification and Revocation of License

  • license maybe revoked, suspended, or modified if the record of inspection shows a violation of
  • no license shall be modified, suspended or revoked unless prior notice has been made
• A.O No. 59 Series of 2001

  Section 11 : Repealing Clause

  • these rules and regulations shall supersede all other previous official issuances hereof

  Section 12 : Publication and List of Licensed Clinical Laboratories

  • a list of licensed clinical laboratories shall be published annually in a newspaper of general circulation

  Section 13 : Effectivity

  • these rules and regulations shall take effect 15 days after its publication in the Official Gazette, or in a newspaper of general circulation
• A.O No. 59 Series of 2001

  Annex A : Technical Standards and Minimum Requirements

  The Clinical Laboratory shall be organized to provide effective and efficient laboratory services

  I. Staffing

  • the clinical laboratory shall be managed by a licensed physician certified by the Philippine Board of Pathology

  If pathologist are not available, a licensed physician with 3 months on training of medical laboratory science