Regulatory and Professional Oversight

• What does laboratory malpractice refer to?

  Incorrect performance or improper conduct by professionals
• What are examples of laboratory malpractice?

  Rushing results, mixing samples, mislabeling
• What is a tort?

  A civil wrong causing harm to another person
• What is negligence in the context of torts?

  Failure to act responsibly causing injury
• What is the most common tort for health professionals?

  Negligence
• What types of damage can negligence cause?

  Physical, pathological, or psychiatric injury
• What is regulation in the context of laboratory management?

  A rule imposed by a government agency
• What does licensure refer to?

  Government permission to operate a business
• What governs the regulation of clinical laboratories in the Philippines?

  Republic Act 4688
• What is the purpose of Republic Act 4688?

  To regulate clinical laboratories and ensure public health
• When was Republic Act 4688 approved?

  June 18, 1966
• What agency was responsible for ensuring public health from substandard laboratories?

  Bureau of Research and Laboratories (BRL)
• What replaced the BRL according to Administrative Order 59 s. 2001?

  Bureau of Health Facilities and Services (BHFS)
• What does Administrative Order 59 s. 2001 govern?

  Establishment, operation, and maintenance of clinical laboratories
• What are the categories of clinical laboratories based on function?

  • Clinical Pathology
  • Anatomic Pathology
• What are the subdivisions of Clinical Pathology?

  • Hematology
  • Clinical Chemistry
  • Microbiology
  • Parasitology
  • Mycology
  • Immunohematology
  • Blood Banking
  • Laboratory Endocrinology
  • Toxicology and Therapeutic Drugs Monitoring
• What are the subdivisions of Anatomic Pathology?

  • Surgical Pathology
  • Immunohistopathology
  • Cytology
  • Autopsy
  • Forensic Pathology
• How are laboratories categorized according to institutional character?

  Hospital-Based and Non-Hospital-Based
• What distinguishes Hospital-Based laboratories from Non-Hospital-Based laboratories?

  Hospital-Based operates within a hospital
• What are the categories of laboratories based on service capability?

  • Primary
  • Secondary
  • Tertiary
• What is the minimum area for a Primary laboratory?

  10 sq.m
• What is the minimum area for a Secondary laboratory?

  20 sq.m
• What is the minimum area for a Tertiary laboratory?

  60 sq.m
• What are the minimum facilities required for a Primary laboratory?

  • Clinical Centrifuge
  • Hemacytometer
  • Microhematocrit centrifuge
  • Microscope with OIO
  • Hemoglobinometer or its equivalent
• What are the minimum facilities required for a Secondary laboratory?

  • Primary laboratory equipment/instruments
  • Refrigerator
  • Photometer or its equivalent
  • Water bath or its equivalent
  • Timer or its equivalent
  • Secondary laboratory equipment/instruments
  • Incubator
  • Trip/analytical balance
  • Rotator
  • Serofuge or its equivalent
  • Autoclave
  • Drying oven
  • Biosafety cabinet or its equivalent
• What are the minimum facilities required for a Tertiary laboratory?

  • All facilities required for Primary and Secondary
• How are laboratories categorized according to ownership?

  Government and Private
• What characterizes Government laboratories?

  Operated by national or local government
• What characterizes Private laboratories?

  Owned and operated by individuals or corporations
• What are the categories of laboratories based on function according to AO 27 s. 2007?

  • Clinical Pathology
  • Anatomic Pathology
• What are the subdivisions of Clinical Pathology according to AO 27 s. 2007?

  • Clinical Chemistry
  • Hematology
  • Immunohematology
  • Microbiology
  • Immunology
  • Clinical Microscopy
  • Endocrinology
  • Molecular Biology
  • Cytogenetics
  • Toxicology
  • Therapeutic Drug Monitoring (TDM)
• What are the subdivisions of Anatomic Pathology according to AO 27 s. 2007?

  • Surgical Pathology
  • Immunohistopathology
  • Cytology
  • Autopsy
  • Forensic Pathology
  • Molecular Pathology
• What is accreditation?

  Certification that standards have been achieved
• What is the role of the Joint Commission on the Accreditation of Healthcare Organizations?

  Ensures compliance with national safety and quality standards
• What does the College of American Pathologists ensure?

  Test results meet industry standards
• What does the American Association of Blood Banks represent?

  Mark of excellence for quality and safety
• What is credentialing?

  Establishing qualifications to perform a duty
• What are the two types of credentialing?

  Program competence and individual competence
• What is the highest level of proof in credentialing?

  Supporting educational or professional achievements
• What is the requirement to sit for a credential exam?

  Certain level of education or experience