Chapter 3: Clinical Laboratory Laws Pretest
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Questions and Answers

What is the significance of the LTO in a clinical laboratory setup?

  • It refers to the location of the laboratory within a hospital.
  • It signifies the level of accreditation of the laboratory.
  • It indicates the type of laboratory services provided.
  • It is a temporary permit required for the operation of a laboratory. (correct)

    • Why is an ideal laboratory setup important?

  • To minimize costs associated with laboratory operations.
  • To facilitate efficient testing processes and accurate results. (correct)
  • To ensure compliance with clinical laboratory laws.
  • To maintain cleanliness and organization in the workspace.

    • What is the minimum floor area requirement for a secondary clinical laboratory?

  • 35 sq. meters
  • 45 sq. meters
  • 25 sq. meters (correct)
  • 15 sq. meters

    • Can the License to Operate (LTO) be temporarily lent to a newly established clinical laboratory?

    <p>No</p> Signup and view all the answers

    Is a satellite clinical laboratory exempted from obtaining a license if it is in a different location from its central laboratory?

    <p>No, it still requires a separate license.</p> Signup and view all the answers

    Who must be professionally in-charge of a registered clinical laboratory?

    <p>A licensed physician</p> Signup and view all the answers

    What is the penalty for violations related to operating and maintaining a clinical lab?

    <p>Imprisonment less than 1 month</p> Signup and view all the answers

    Who is authorized to issue rules and regulations regarding clinical lab operations?

    <p>Secretary of Health</p> Signup and view all the answers

    Under what condition is a government hospital lab exempted from registering and securing a license at the office of the Secretary of Health?

    <p>If their services are extensions of government regional or central lab</p> Signup and view all the answers

    What is the required amount for the registration fee of a clinical lab?

    <p>$50,000</p> Signup and view all the answers

    When was this regulation approved?

    <p>June 18, 1966</p> Signup and view all the answers

    What action will be taken if a clinical lab fails to correct deficiencies after due notice?

    <p>Investigate the complaint and verify guilt</p> Signup and view all the answers

    When will the regulations come into effect?

    <p>15 days after publication in the official Gazette</p> Signup and view all the answers

    What is the consequence of declaring a rule invalid?

    <p>Repeal or amendment of inconsistent rules</p> Signup and view all the answers

    Who is authorized to investigate complaints against clinical labs or their personnel?

    <p>Any person or interested party</p> Signup and view all the answers

    Which document governs the establishment and operation of clinical labs in the Philippines?

    <p>Admin O #59 s. 2001</p> Signup and view all the answers

    How long is the period of suspension that can be imposed for violating the regulations?

    <p>Indefinite period</p> Signup and view all the answers

    What is the main purpose of the Rules and Regulations governing the accreditation of Clinical Laboratories for the training of Medical Technologist Interns?

    <p>To ensure that only accredited Clinical Laboratories can train Medical Technologist Interns.</p> Signup and view all the answers

    Who is responsible for the regulatory authority over the accreditation of Clinical Laboratories for the training of Medical Technologist Interns?

    <p>Department of Health through the Bureau of Research and Laboratories</p> Signup and view all the answers

    What is one of the requirements for a Clinical Laboratory to be accredited for training Medical Technologist Interns?

    <p>Reporting a volume of exams performed in the previous year/section.</p> Signup and view all the answers

    Who is authorized to sign the application for accreditation for a Clinical Laboratory?

    <p>The owner or an authorized representative.</p> Signup and view all the answers

    What happens if a Clinical Laboratory applies for renewal of accreditation 100 days after expiration?

    <p>They face a non-refundable penalty.</p> Signup and view all the answers

    What action must be taken by Health Officers if they discover an unaccredited Clinical Laboratory training Medical Technologist Interns?

    <p>Report it to Regional Health Office, Provincial, or Municipal officers.</p> Signup and view all the answers

    What program should the lab have for staff development?

    <p>Staff development and continuing education</p> Signup and view all the answers

    Which of the following is a requirement for equipment in the lab?

    <p>Calibration, preventive maintenance, and repair program</p> Signup and view all the answers

    What is necessary for glass wares, reagents, and supplies in the lab?

    <p>Being stored under specific conditions</p> Signup and view all the answers

    Which signature is required on all lab results?

    <p>Both the pathologist's facsimile signature and RMT's name</p> Signup and view all the answers

    Which QA program should the lab participate in?

    <p>External Quality Assurance Program administered by NRL</p> Signup and view all the answers

    What is the responsibility of the Board of Pathology Head?

    <p>Technical supervision of the lab activities</p> Signup and view all the answers

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