Clinical Laboratory Overview and Laws in the Philippines
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Questions and Answers

What is the primary purpose of Republic Act No. 4688?

  • To promote research in medical laboratories
  • To provide funding for technological advancements
  • To regulate industrial operations
  • To regulate the operation and maintenance of clinical laboratories (correct)

    • What happens if a part of this Act is deemed invalid by a court?

  • Legal penalties are imposed on the Act
  • The entire Act becomes invalid
  • Only the invalid part is struck down
  • The remaining sections remain unaffected (correct)

    • What financial amount is authorized to carry into effect the provisions of this Act?

  • Twenty-five thousand pesos
  • Seventy-five thousand pesos
  • One hundred thousand pesos
  • Fifty thousand pesos (correct)

    • What does Section 7 of the Act do?

    <p>Repeals inconsistent acts or parts of acts</p> Signup and view all the answers

    When does Republic Act No. 4688 take effect?

    <p>Upon its approval</p> Signup and view all the answers

    What is one significant role of a Medical Technologist in the clinical laboratory?

    <p>Ensuring the reliability of test results</p> Signup and view all the answers

    Which classification of clinical laboratories focuses on the purpose they serve?

    <p>According to Function</p> Signup and view all the answers

    How are clinical laboratories classified according to their management?

    <p>According to Ownership</p> Signup and view all the answers

    Which law pertains specifically to the operation of clinical laboratories in the Philippines?

    <p>Republic Act No. 4688</p> Signup and view all the answers

    What is NOT a characteristic used to classify clinical laboratories?

    <p>According to Personnel Qualifications</p> Signup and view all the answers

    Which classification method does not pertain to the function of clinical laboratories?

    <p>According to Testing Procedures</p> Signup and view all the answers

    What does the classification according to service capability refer to?

    <p>The types of tests the laboratory can perform</p> Signup and view all the answers

    Which of the following is an integral characteristic of clinical laboratories in the healthcare delivery system?

    <p>They are partners of medical doctors</p> Signup and view all the answers

    What must a clinical laboratory owner do before transferring their laboratory to a new location?

    <p>Notify the CHD at least 15 days in advance</p> Signup and view all the answers

    What is the nature of the license fee for a clinical laboratory?

    <p>It is a non-refundable license fee</p> Signup and view all the answers

    What is the penalty for late renewal of a clinical laboratory license?

    <p>One thousand pesos</p> Signup and view all the answers

    What happens if a clinical laboratory does not report changes affecting license conditions within the stipulated time?

    <p>The laboratory's license may be revoked</p> Signup and view all the answers

    What is required if a clinical laboratory wishes to expand its services?

    <p>An extension laboratory requires a separate license</p> Signup and view all the answers

    When must the application for a renewal of a license be filed to avoid a penalty?

    <p>Before the previous license expires</p> Signup and view all the answers

    Where must the clinical laboratory license be displayed?

    <p>In a conspicuous location within the laboratory</p> Signup and view all the answers

    All fees related to the licensing of a clinical laboratory must follow what?

    <p>Current prescribed schedules of fees</p> Signup and view all the answers

    What is the penalty for submitting an application more than two months after the expiry date?

    <p>P100.00 for each month thereafter in addition to P1,000.00 penalty</p> Signup and view all the answers

    Which act is considered a violation regarding the operation of a clinical laboratory?

    <p>Operating without a certified pathologist</p> Signup and view all the answers

    Under what circumstance can a license be revoked or modified?

    <p>If there is a violation of public health interest</p> Signup and view all the answers

    What is a consequence of refusing inspection of the clinical laboratory?

    <p>It is considered a violation</p> Signup and view all the answers

    What must be made before a license can be suspended or revoked?

    <p>Prior notice and an investigation</p> Signup and view all the answers

    What happens to previous official issuances when the new rules and regulations take effect?

    <p>They are fully superseded by the new regulations</p> Signup and view all the answers

    Which of the following is NOT a violation as per the outlined regulations?

    <p>Employing registered medical technologists</p> Signup and view all the answers

    What is required from the laboratory regarding inspection availability?

    <p>Must be made available at any reasonable time</p> Signup and view all the answers

    What are the three phases of the laboratory testing cycle?

    <p>Pre-analytic, Analytic, Post-analytic</p> Signup and view all the answers

    What does quality assurance in the clinical laboratory encompass?

    <p>All activities performed by laboratory personnel</p> Signup and view all the answers

    What does the pre-analytic phase include?

    <p>Receipt of the lab request and patient preparation</p> Signup and view all the answers

    Which component is part of internal quality assurance systems?

    <p>Regular review and audit of results</p> Signup and view all the answers

    What is the focus of the analytic phase in the laboratory testing cycle?

    <p>Using equipment and testing specimens</p> Signup and view all the answers

    Why is proper transport of specimens important in the pre-analytic phase?

    <p>To prevent contamination and ensure test validity</p> Signup and view all the answers

    What is a goal of quality assurance in the clinical laboratory?

    <p>Ensuring reliability of test results</p> Signup and view all the answers

    What aspect does NOT belong to the analytic phase of laboratory testing?

    <p>Patient preparation and specimen collection</p> Signup and view all the answers

    Study Notes

    The Clinical Laboratory

    • Medical technologists/clinical lab scientists play a significant role in performing lab tests and guaranteeing the accuracy of results
    • Are an essential part of the healthcare system
    • Work closely with medical doctors
    • Evaluate new and evolving diagnostic techniques

    Classifications of Clinical Laboratories

    • Clinical Labs can be categorized based on function, institutional characteristics, ownership, and service capabilities

    Laws Affecting Clinical Laboratories in the Philippines

    • Republic Act No. 4688 (Clinical Laboratory Act)
      • Established to prevent the operation of substandard labs
      • Ensures the registration of clinical laboratories with the Department of Health (DOH)
      • Outlines penalties for violating the act
    • Administrative Order No. 59 Series of 2001
      • Grants the Secretary of Health the right to suspend or revoke clinical laboratory licenses when R.A. 4688 or its related rules are violated
      • The act of operating a lab without a certified pathologist or registered technologist is a violation of R.A 4688

    Application Fees, Inspections, and Violations

    • Applications for permits to construct, licenses, and license renewals require non-refundable fees determined by the DOH
    • The owner or authorized representative of a licensed clinical laboratory must inform the DOH of any change in location, ownership, or head of the laboratory
    • The license must be displayed prominently in the laboratory
    • Violators of the Clinical Laboratory Act face penalties including potential license revocation

    Laboratory Testing Cycle

    • The process of generating test results with usefulness for patient care
    • Composed of three phases:
      • Pre-Analytic:
        • Laboratory request is made
        • Patient preparation, specimen collection and proper transport
        • The specimen undergoes processing for lab analysis
      • Analytic:
        • Actual testing of the specimen
        • This phase involves testing equipment, reagents, and internal quality control
      • Post-Analytic:
        • Test results are reviewed by lab personnel
        • Information is verified and any discrepancies investigated
        • The results are communicated to the requesting physician
        • Errors during this phase are often attributed to transcription.

    Quality Assurance in the Clinical Laboratory

    • Aims to guarantee trustworthy test results
    • Is a consistent and planned process
    • Involves internal quality assurance (IQAS) with daily tasks. These tasks aim to control factors that may influence test results.

    Internal Quality Assurance System (IQAS)

    • IQAS is a key component of quality assurance
    • Reviews and audits of results regularly take place
    • This allows weaknesses to be identified, and corrective actions to be implemented
    • Ensures the accuracy and reliability of test results

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    Description

    This quiz covers the vital role of medical technologists and clinical laboratory scientists in healthcare, focusing on their responsibilities in ensuring accurate lab test results. It also explores the classifications of clinical laboratories and highlights important laws affecting them, such as the Clinical Laboratory Act and related administrative orders in the Philippines.

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