Medtech Law and Bioethics

• R.A. No.4688


  CLINICAL LABORATORY ACT OF 1966
• Date of effectivity of the Clinical Laboratory Act

  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 and Laboratories


  • Tasked with enforcing the provisions 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 examinations 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 the Act
• A.O. No. 0027 s. 2007


  REVISED RULES AND REGULATIONS GOVERNING THE LICENSURE REGULATION OF CLINICAL LABORATORIES IN THE PHILIPPINES

  
• Classification of Clinical Laboratories by Ownership

  • Government
  • Private
• Classification of Clinical Laboratories by Function

  • Clinical Pathology
  • Anatomic Pathology
• Classification of Clinical Laboratories by Institutional Character

  • Institution-based
  • Free-standing
• Classification of Clinical Laboratories by Service Capability

  • General Clinical Laboratory - Primary Category
  • General Clinical Laboratory - Secondary Category
  • General Clinical Laboratory - Tertiary Category
  • Limited Service Capability (for Institution-based only)
  • Special Clinical Laboratory
• National Reference Laboratory (NRL)


  • Laboratory in a government hospital which had been designated by DOH to provide special functions and services: Confirmatory Testing, Surveillance, Resolution of Conflicts, Training and Research, Evaluation of Kits and Reagents, External Quality Assessment Program
• 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 testing site 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 100km radius from its main laboratory
• License to Operate (LTO)


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

  
• LTO Contents

  • Name of the Clinical Laboratory
  • Name of the Owner or Operator
  • Head of the Laboratory
  • Types of Services Offered
  • Period of Validity
  • License Number
  • Location Wherein the Laboratory Procedures are to be Performed
• Top 10 Violations to R.A. 4688


  • Refusal to participate in EQAP (External Quality Assessment Program)
  • Issuance of a report (orally or in writing) which is NOT in accordance with the documented procedure approved by the head of the laboratory
  • Permitting UNAUTHORIZED PERSONS to perform technical procedures
  • INCOMPETENCE: consistent errors in the laboratory examinations
  • SUBSTANDARD TEST PROCEDURES: use of expired reagents
  • ERRONEOUS RESULTS: (a) Tampered result, (b) Result from an UNTESTED specimen
  • Lending or using the name of a licensed clinical laboratory or licensed personnel to or by an unlicensed clinical laboratory or unlicensed personnel
  • Unauthorized use of the name and signature of a pathologist and/or a medical technologist to secure LTO
  • Transferring of results of tests done in an outside clinical laboratory to a result form of the referring laboratory
  • Performing and reporting tests in a specialty or subspecialty in which the laboratory is NOT licensed
• A.O. No 2021-0037


  NEW RULES AND REGULATIONS GOVERNING THE REGULATION OF CLINICAL LABORATORIES IN THE PHILIPPINES

  
• Classification of Clinical Laboratories by Institutional Character

  • Institution-based
  • Non-institution based
• Classification of Clinical Laboratories by Function

  • Clinical Pathology
  • Anatomic Pathology
  • Molecular Pathology
• Classification of Clinical Laboratories by Service Capability

  • Clinical Laboratory for Clinical and Anatomic Pathology
  • Clinical Laboratory for Anatomic Pathology only
  • Clinical Laboratory for Molecular Pathology only
• Licensing Standards for Clinical Laboratory

  • Physical Plant
  • Personnel
• Head of the Laboratory (HOL)

  • The head of the laboratory shall be a competent and experienced professional, with a specialized skill set related to and proportionate to the laboratory category, to ensure that the laboratory runs efficiently. The head of the laboratory is essentially responsible for the operation of the entire laboratory, its personnel, functions, and data, all of which shall meet the quality assurance criteria and regulatory requirements
• Laboratory biosafety and biosecurity


  Includes risk assessment that will serve as the basis of biosafety level required for the specific CL
• Confirmatory testing for Rapid HIV Diagnostic Algorithm (CrCL) and Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency


  May be a section, unit, or division integrated in a DOH licensed CL, if applicable
• Every CL

  • Shall have an adequate number of trained personnel, depending on the workload, to provide safe, effective and efficient services to clients
• Head of the laboratory (HOL)


  A competent and experienced professional, with a specialized skill set related to and proportionate to the laboratory category, to ensure that the laboratory runs efficiently
• Responsibilities of the head of the laboratory

  1. Responsible for the operation of the entire laboratory, its personnel, functions, and data, all of which shall meet the quality assurance criteria and regulatory requirements

  2. Oversee the operation of the CL and have administrative and technical supervision of the activities including the mobile clinical laboratories (MCL), remote collection activities, and point of care testing (POCT), if applicable

  3. Supervise the staff in accordance to the standards set by the Philippine Society of Pathologists

  4. Visit once a month and at least twice a week of supervisory calls and/or videoconferencing OR at least once a week physical visit. The visits shall have to be well documented
• Registered Medical Technologist (RMT)

  There shall be an adequate number of full-time RMTs to conduct the laboratory procedures, including those assigned in MCL. The number of staff shall depend on the workload and the services being provided

  
• Staff development and continuing education program


  At all levels or organization to upgrade the knowledge, attitude and skills of staff
• Biosafety and Biosecurity Officer


  Designated in-charge primarily of the risk assessment of the DOH licensed CL
• Support staff

  • Laboratory technician
  • Laboratory aide
  • Encoders
  • Receptionist
• Proper disposal of infectious wastes and toxic and hazardous substances

  In accordance with RA 6969, also known as "Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990" and other related policy guidelines and/or issuances
• There shall be a "No smoking policy" and that the same shall be strictly enforced
• There shall be a policy for biosafety and biosecurity