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    H. Clinical Laboratory Laws (Technical Standards)

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    Armie Joy Maningat
    These Technical Standards establish rules for the registration, operation, and maintenance of clinical laboratories in the Philippines. They classify laboratories into primary, secondary, and tertiary categories based on their functions, institutional characteristics, and service levels. The standards specify requirements for laboratory heads, personnel, physical facilities, equipment, quality control programs, reporting, record keeping, and fees. Laboratories must meet minimum standards for these areas to ensure accurate, reliable testing and reporting of results.

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    H. Clinical Laboratory Laws (Technical Standards)

    Uploaded by

    Armie Joy Maningat
    7 views15 pages
    These Technical Standards establish rules for the registration, operation, and maintenance of clinical laboratories in the Philippines. They classify laboratories into primary, secondary, and tertiary categories based on their functions, institutional characteristics, and service levels. The standards specify requirements for laboratory heads, personnel, physical facilities, equipment, quality control programs, reporting, record keeping, and fees. Laboratories must meet minimum standards for these areas to ensure accurate, reliable testing and reporting of results.

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    These Technical Standards establish rules for the registration, operation, and maintenance of clinical laboratories in the Philippines. They classify laboratories into primary, secondary, and tertiary categories based on their functions, institutional characteristics, and service levels. The standards specify requirements for laboratory heads, personnel, physical facilities, equipment, quality control programs, reporting, record keeping, and fees. Laboratories must meet minimum standards for these areas to ensure accurate, reliable testing and reporting of results.

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    © All Rights Reserved
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    Download as pptx, pdf, or txt
    7 views15 pages

    H. Clinical Laboratory Laws (Technical Standards)

    Uploaded by

    Armie Joy Maningat
    These Technical Standards establish rules for the registration, operation, and maintenance of clinical laboratories in the Philippines. They classify laboratories into primary, secondary, and tertiary categories based on their functions, institutional characteristics, and service levels. The standards specify requirements for laboratory heads, personnel, physical facilities, equipment, quality control programs, reporting, record keeping, and fees. Laboratories must meet minimum standards for these areas to ensure accurate, reliable testing and reporting of results.

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    © All Rights Reserved
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    of 15

    Technical Standards for the

    Registration, Operation, and


    Maintenance of Clinical
    Laboratories in the Philippines
    Section 1. Title
    • What is the title of these Technical Standards?
    Section 2. Authority
    These Technical Standards are issued to implement:
    • RA 4688 (Clinical Laboratory Law)
    • With its Revised Rules and Regulations (AO 49-B s. 1988)
    • Consistent with EO 119 (Reorganization Act of the Ministry of Health)
    Section 3. Purpose
    What are the purposes of these Technical Standards?
    Section 4. Scope
    • What is the scope of these Technical Standards?
    Section 5. Classification
    1. How are Clinical Laboratories Classified based on these Technical Standards?
    2. What are the types and characteristics of Clinical Laboratories according to:
    a. Function
    b. Institutional character
    c. service extent and level
    Section 6. Service Capabilities
    • What are the minimum services required for the following:
    a. Primary Category Clinical Laboratories
    b. Secondary Category Clinical Laboratories
    c. Tertiary Category Clinical Laboratories
    Section 7. Standards
    Head:
    1. What are the characteristics of the head of a clinical laboratory?
    2. What are the characteristics of the head of a primary free-standing clinical laboratory?
    3. What are the characteristics of the head of a secondary free-standing clinical
    laboratory?
    4. What are the characteristics of the head of a primary hospital-based clinical laboratory
    where pathologists are not available?
    5. What are the characteristics of the head of a tertiary hospital and free-standing clinical
    laboratory?
    6. How many clinical laboratories and/or blood banks can be managed by a certified
    pathologist?
    7. How many clinical laboratories and/or blood banks can be managed by physician who
    is not a certified pathologist?
    Personnel:
    • How many Medical Technologist/s registered with the Board of Medical
    Technology (PRC) is/are required in a clinical laboratory?
    Physical Facilities:
    How wide is the minimum working area for:
    1. Primary laboratories?
    2. Secondary laboratories?
    3. Tertiary laboratories?
    Equipment:
    1. What are the minimum recommended equipment for a primary laboratory?
    2. What are the minimum recommended equipment for a secondary laboratory?
    3. What are the minimum recommended equipment for a tertiary laboratory?
    4. What are the minimum recommended equipment for a laboratory offering
    anatomic pathology services?
    Quality Control
    1. What are some of the components of the Internal Quality Control Program?
    2. What are some of the components of the External Quality Control Program?
    Reporting
    • What are to be observed when reporting laboratory results?
    Recording
    1. What are the protocols to be observed when recording laboratory results?
    2. How long should clinical laboratory reports be kept on file?
    3. How long should reports of anatomic and forensic pathology be kept in the
    laboratory?
    Laboratory Fees
    • What are the characteristics of the recommended laboratory and professional
    fees?

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