Clinical Laboratory Overview
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Clinical Laboratory Overview

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Questions and Answers

What is the primary function of a clinical laboratory?

  • To perform surgeries on patients
  • To provide accurate and reliable results on specimens (correct)
  • To administer medications directly to patients
  • To train medical professionals

    • Which of the following is not a section included in the clinical laboratory?

  • Anatomic pathology
  • Microbiology
  • Physical therapy (correct)
  • Hematology

    • What aspect of clinical laboratory testing does quality assurance primarily focus on?

  • The cost of laboratory equipment
  • The accuracy and reliability of test results (correct)
  • Patient interaction
  • The administration of staff

    • Which type of clinical laboratory is operated and maintained by the national government?

    <p>Government laboratory</p> Signup and view all the answers

    What does the term 'TAT' in clinical laboratories refer to?

    <p>Turnaround Time</p> Signup and view all the answers

    Which procedure is not part of the clinical laboratory testing cycle?

    <p>Follow-up procedures</p> Signup and view all the answers

    What is the benefit of automated clinical laboratories compared to traditional methods?

    <p>Increased reliability and less labor intensity</p> Signup and view all the answers

    What kind of problems might a clinical laboratory face if the results of tests are not accurate?

    <p>Misdiagnosis and inappropriate patient management</p> Signup and view all the answers

    What is the minimum floor area required for a tertiary category clinical laboratory?

    <p>60 square meters</p> Signup and view all the answers

    Which of the following is NOT a role of the National Reference Laboratory?

    <p>Conduct surgical procedures</p> Signup and view all the answers

    For which type of clinical laboratory is a minimum floor area of 20 square meters required?

    <p>Secondary Category</p> Signup and view all the answers

    Which statement about Limited Services clinical laboratories is true?

    <p>They include facilities like dialysis centers and social hygiene clinics.</p> Signup and view all the answers

    Which of the following best describes the primary category of clinical laboratories?

    <p>Designed for clinical and anatomic pathology with 10 square meters minimum area.</p> Signup and view all the answers

    What distinguishes an institution-based laboratory from a non-institution based laboratory?

    <p>It is located within the premises of a DOH licensed health facility.</p> Signup and view all the answers

    Which of the following is a characteristic of clinical pathology?

    <p>Performing hematology and coagulation tests.</p> Signup and view all the answers

    Which option is NOT a type of laboratory based on function?

    <p>Environmental pathology</p> Signup and view all the answers

    Molecular pathology primarily involves the analysis of what types of samples?

    <p>Tissues and body fluids.</p> Signup and view all the answers

    What is the primary function of anatomic pathology?

    <p>Processing surgical specimens.</p> Signup and view all the answers

    Which laboratory would provide immunohistochemical techniques?

    <p>Anatomic pathology laboratory.</p> Signup and view all the answers

    Clinical laboratories based on service capability include which of the following?

    <p>Laboratories for both clinical and anatomic pathology.</p> Signup and view all the answers

    Which type of laboratory focuses specifically on genes and proteins analysis?

    <p>Molecular pathology laboratory.</p> Signup and view all the answers

    What is the primary focus of the clinical chemistry section in a laboratory?

    <p>To quantify soluble chemicals in body fluids</p> Signup and view all the answers

    Which of the following tests is commonly performed in clinical chemistry?

    <p>Hemoglobin A1C (HBA1C)</p> Signup and view all the answers

    In the pre-analytical phase of laboratory testing, which factor could affect the accuracy of a test result?

    <p>The time of day the test is conducted</p> Signup and view all the answers

    Which two components are vital to quality assurance in a clinical laboratory?

    <p>External Quality Assurance System and Internal Quality Assurance System</p> Signup and view all the answers

    Which of the following is a common variable in the pre-analytical phase that may influence laboratory test outcomes?

    <p>Patient's medication usage</p> Signup and view all the answers

    Which national reference laboratory is known for its work in drug and water testing?

    <p>East Avenue Medical Center (EAMC)</p> Signup and view all the answers

    What is a major challenge in conducting tests within the clinical laboratory?

    <p>Ensuring timely preparation of specimens</p> Signup and view all the answers

    Which of the following is a parameter that must be carefully controlled in a laboratory setting?

    <p>Volume of specimen collected</p> Signup and view all the answers

    What is the primary purpose of the Clinical Chemistry section of a clinical laboratory?

    <p>To measure essential soluble chemicals in body fluids.</p> Signup and view all the answers

    Which of the following tests is performed in the Hematology and Coagulation Studies section?

    <p>Complete blood count.</p> Signup and view all the answers

    What is a major function of the Immunology and Serology section in a clinical laboratory?

    <p>To analyze serum antibodies against infectious agents.</p> Signup and view all the answers

    Which phase of laboratory testing involves the actual performance of tests on collected specimens?

    <p>Analytic Phase.</p> Signup and view all the answers

    What does the Internal Quality Assurance System (IQAS) primarily focus on?

    <p>Controlling daily activities to ensure accurate test results.</p> Signup and view all the answers

    Which section of the clinical laboratory is primarily responsible for analyzing parasites in stool samples?

    <p>Clinical Microscopy.</p> Signup and view all the answers

    Which specialized section of the clinical laboratory utilizes techniques combining anatomical, clinical, and biochemical methods?

    <p>Immunohistochemistry.</p> Signup and view all the answers

    What type of testing does the Microbiology section primarily conduct?

    <p>Testing for the presence of microorganisms.</p> Signup and view all the answers

    What is the purpose of the External Quality Assurance System (EQAS)?

    <p>To evaluate lab performance among multiple labs.</p> Signup and view all the answers

    Which test would be performed in the Clinical Microscopy section?

    <p>Urinalysis.</p> Signup and view all the answers

    What is one key activity performed in the Histopathology/Cytology section?

    <p>Staining tissue sections.</p> Signup and view all the answers

    What is the main function of the Blood Bank/Immunohematology section?

    <p>Blood typing and compatibility testing.</p> Signup and view all the answers

    Which of the following tests falls under the purview of the Clinical Chemistry section?

    <p>Total cholesterol.</p> Signup and view all the answers

    What does the term 'polymerase chain reaction' refer to in the context of Molecular Biology and Biotechnology?

    <p>A method for amplifying DNA.</p> Signup and view all the answers

    What is one of the requirements to apply for a permit to construct a clinical laboratory?

    <p>A letter of application to the director of BHFS</p> Signup and view all the answers

    Which category includes immunology and serology laboratories?

    <p>Tertiary category</p> Signup and view all the answers

    What must be obtained before starting construction of a clinical laboratory?

    <p>An approved permit to construct and a design layout</p> Signup and view all the answers

    What is a policy requirement for clinical laboratories regarding safety practices?

    <p>To provide adequate and appropriate safety practices</p> Signup and view all the answers

    What must be secured from the BHFS before operating a clinical laboratory?

    <p>A valid license issued by BHFS/CHD</p> Signup and view all the answers

    What aspect is considered when setting laboratory fees?

    <p>The usual fees prevailing at the time</p> Signup and view all the answers

    Which type of laboratory classification focuses on the functionality of tests provided?

    <p>Classification by Function</p> Signup and view all the answers

    Which of the following is a primary focus area within anatomic pathology?

    <p>Cytopathology</p> Signup and view all the answers

    What is the main distinction between institution-based and non-institution based laboratories?

    <p>Affiliation to a healthcare organization</p> Signup and view all the answers

    Which of the following laboratory classifications is based on the examination methods utilized?

    <p>Molecular Pathology</p> Signup and view all the answers

    What is included in the clinical laboratory fees according to the regulations?

    <p>Cost of testing and quality control</p> Signup and view all the answers

    Which section of the laboratory would conduct testing related to virology?

    <p>Clinical Pathology</p> Signup and view all the answers

    What is NOT a component of clinical pathology?

    <p>Surgical pathology</p> Signup and view all the answers

    Who is responsible for being in charge of a registered clinical laboratory?

    <p>A licensed physician qualified in laboratory medicine</p> Signup and view all the answers

    What is the penalty for violating any provision of the Act according to the regulations?

    <p>Imprisonment of no less than one month but not more than one year and/or a fine of no less than one thousand pesos</p> Signup and view all the answers

    Which entity is responsible for enforcing the provisions of the Act?

    <p>The Bureau of Research and Laboratories under the Secretary of Health</p> Signup and view all the answers

    Under what condition are government hospital laboratories exempt from registration and licensing requirements?

    <p>If they are doing routine or minimum laboratory examinations as extensions of government regional or central laboratories</p> Signup and view all the answers

    What happens if any section of the Act is deemed invalid?

    <p>Only the invalid section is removed, and the remainder remains effective</p> Signup and view all the answers

    What is required for the authorization of a licensed physician in charge of a laboratory?

    <p>It must be renewed annually</p> Signup and view all the answers

    What is the budget authorized to carry out the provisions of the Act?

    <p>Fifty thousand pesos or as necessary from the National Treasury</p> Signup and view all the answers

    Which of the following is NOT a part of the responsibilities outlined for the Secretary of Health?

    <p>Registering and licensing clinical laboratories</p> Signup and view all the answers

    What is the first step an owner must take to apply for a new license to operate a clinical laboratory?

    <p>File a duly notarized application form at the BHFS</p> Signup and view all the answers

    When should an application for renewal of a clinical laboratory license be filed?

    <p>Within 90 days before the expiry date of the license</p> Signup and view all the answers

    What is the penalty for late renewal of a clinical laboratory license within 2 months after expiration?

    <p>Php1,000.00 penalty plus any applicable renewal fee</p> Signup and view all the answers

    What is required from the laboratories during inspections conducted by the BHFS or CHD?

    <p>Premises and all pertinent records must be made available</p> Signup and view all the answers

    What must a clinical laboratory do if it plans to transfer its location?

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

    If substantial changes occur affecting clinical laboratory licensing conditions, how soon must these be reported?

    <p>Within 15 days</p> Signup and view all the answers

    What kind of fees are associated with the application to construct and license to operate a clinical laboratory?

    <p>Non-refundable application fees</p> Signup and view all the answers

    Who is responsible for issuing the license if the clinical laboratory application is meritorious?

    <p>The director of CHD or his authorized representative</p> Signup and view all the answers

    How frequently are inspections for clinical laboratories conducted?

    <p>Every 2 years or as necessary</p> Signup and view all the answers

    What type of clinical laboratory license is necessary for an extension laboratory?

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

    What must a clinical laboratory do to maintain its License to Operate (DOH-LTO) after any significant change in management?

    <p>Notify HFSRB/CHD-RLED in writing within fifteen days</p> Signup and view all the answers

    What is the implication if an application for DOH-LTO is not processed within twenty days due to force majeure?

    <p>The LTO is automatically granted</p> Signup and view all the answers

    Which of the following statements is true regarding the License to Operate (DOH-LTO) for different branches of a clinical laboratory?

    <p>Each branch must secure its own separate LTO</p> Signup and view all the answers

    What is the consequence of failing to comply with deficiencies identified after an on-site assessment?

    <p>The license can be suspended or revoked</p> Signup and view all the answers

    Which document is NOT required as part of the complete application for DOH-LTO?

    <p>Proof of operational health facility standards</p> Signup and view all the answers

    When is the DOH-LTO considered non-transferable?

    <p>When the ownership structure changes</p> Signup and view all the answers

    What happens if a laboratory does not correct identified deficiencies within thirty days?

    <p>The laboratory is at risk of losing its license</p> Signup and view all the answers

    Where should the DOH-LTO be displayed?

    <p>In a public area readily visible to the public</p> Signup and view all the answers

    Study Notes

    The Clinical Laboratory

    • A clinical laboratory processes, analyzes, preserves, and properly disposes of specimens from the human body.
    • They provide accurate and reliable results to aid in patient diagnosis, treatment, and monitoring.
    • The laboratory can be categorized into manual and automated, where automated testing is faster with higher reliability.

    Classification of Clinical Laboratories

    • Ownership:
      • Government: Operated and maintained by the national government, such as San Lazaro Hospital and UP-PGH.
      • Private: Privately owned, such as St Elizabeth Hospital (MediLinx Laboratory) and Vitalab.
    • Institutional Character:
      • Institution Based: Laboratory located within and operates as part of a DOH licensed health facility.
      • Non-Institution Based: Laboratory operates independently and is not attached to any DOH licensed health facility.
    • Function:
      • Clinical Pathology: Provides chemical and cellular analyses of blood and other body fluids, identification and examination of microbes and parasites. Includes:
        • Clinical chemistry
        • Clinical microscopy
        • Toxicology
        • Therapeutic drug monitoring
        • Immunology and serology
        • Hematology and coagulation
        • Bacteriology
        • Parasitology
        • Mycology
        • Virology
      • Anatomic Pathology: Provides processing and examination of surgical specimens, and includes:
        • Surgical pathology
        • Cytopathology
        • Immunohistochemical techniques
        • Autopsies
        • Forensic pathology
      • Molecular Pathology: Analysis of genes, proteins, and other molecules in samples from organs, tissues or body fluids.
    • Service Capability:
      • Clinical Laboratory for Clinical and Anatomic Pathology: Further classified into Primary, Secondary, Tertiary, and Limited Services.
        • Primary Category: Minimum of 10 square meters of floor area.
        • Secondary Category: Minimum of 20 square meters of floor area.
        • Tertiary Category: Minimum of 60 square meters of floor area.
        • Limited Services: Found in dialysis centers and social hygiene clinics.
      • Clinical Laboratory for Anatomic Pathology ONLY: Exclusively analyzes surgical specimens
      • Clinical Laboratory for Molecular Pathology ONLY: Exclusively analyzes genes, proteins, and other molecules
      • National Reference Laboratory:
        • Governed by the Department of Health (DOH)
        • Found in Government Hospitals
        • Specializes in diagnostic functions and services
        • Provides reference/referral services for confirmatory testing
        • Trains laboratory personnel and recognizes other training institutions
        • Maintains the national external quality assessment scheme
        • Performs technical evaluation of reagents and diagnostic kits.

    ### Clinical Laboratory Sections

    • Clinical Chemistry quantifies essential soluble chemicals in blood and other fluids for diagnosing diseases
      • Tests include:
        • Fasting blood sugar
        • Glycosylated hemoglobin (HbA1c)
        • Total cholesterol
        • Triglycerides
        • Blood uric acid
        • Creatinine
        • Total protein
        • Albumin
        • Electrolytes
        • Clinical enzymology
        • Endocrinology (hormones)
        • Toxicology and drug testing
    • Microbiology identifies and tests microorganisms
      • Subdivided into four sections:
        • Bacteriology
        • Mycobacteriology
        • Mycology
        • Virology
      • Tests include:
        • Blood cultures
        • Antimicrobial susceptibility testing
        • Microscopic visualization of microorganisms and fungi
        • Biochemical tests
        • Antigen typing
        • Antibacterial susceptibility testing
        • Preparation of culture media and stains
      • Focuses on: Infection control, quality control and assurance, biosafety and proper waste disposal
    • ** Hematology and Coagulation Studies** enumerates cells and assesses coagulation factors
      • Tests include:
        • Complete blood count
        • Hemoglobin
        • Hematocrit
        • White blood cell differential count
        • Red cell morphology and indices
        • Quantitative platelet count
        • Total cell count and differential count
        • Blood smear preparation
        • Staining other body fluids
    • Clinical Microscopy examines urine and stool samples
      • Major areas include:
        • Routine and special examinations of urine
        • Examination of stool samples (routine fecalysis)
      • Tests include:
        • Macroscopic examinations
        • Microscopic examinations
        • Biochemical determinations
        • Detection and identification of parasitic worms and ova
    • Blood Bank/Immunohematology determines blood types and performs compatibility testing for transfusions
      • Most critical section
      • Tests include:
        • Blood typing
        • Compatibility testing
        • Blood components for transfusion
    • Immunology and Serology analyzes serum antibodies for infectious agents
      • Commonly uses automated analyzers
      • Tests include:
        • Hepatitis B profile tests
        • Serological tests for syphilis
        • Hepatitis C
        • Dengue fever
    • Histopathology/Cytology examines tissues for diagnosing diseases
      • Tests include:
        • Tissue processing
        • Cutting into sections
        • Staining
        • Preparation for microscopic examination

    Specialized Sections in the Clinical Laboratory

    • Immunohistochemistry combines anatomical, clinical, and biochemical techniques for diagnosing neurodegenerative diseases and responses to cancer therapy
      • Uses antibodies bound to enzymes and fluorescent dyes to detect presence of antigens in tissue
      • Tests include:
        • Tumor specific antigens
        • Oncogenes
        • Tumor suppressor genes
    • Molecular Biology and Biotechnology identifies DNA and RNA using enzymes and other reagents
      • Tests include:
        • Polymerase chain reaction (PCR)

    Laboratory Testing Cycle

    • Consists of three phases

      • Pre-analytic Phase: Begins with the laboratory test requisition/order and ends with the specimen being transported and processed
        • Includes:
          • Order reception
          • Patient preparation
          • Specimen collection
          • Specimen transport and processing
      • Analytic Phase: Involves actual testing of the specimen
        • Includes:
          • Specimen transport
          • Actual testing
          • Processing
      • Post-analytic Phase: Incorporates data transmission and interpretation, results application, and turnaround time (TAT)
        • Includes:
          • Data transmission/interpretation
          • Results application
          • TAT

    Quality Assurance in the Clinical Laboratory

    • Includes all activities to ensure reliable test results
    • Consists of two major components:
      • Internal Quality Assurance System (IQAS): day-to-day activities that control variables affecting test results
      • External Quality Assurance System (EQAS): checks performance among clinical laboratories
        • Facilitated by designated external agencies
        • National Reference Laboratory, designated by the Department of Health (DOH)
          • Evaluates participating laboratories’ performance
          • Required for securing a license under local regulatory policies

    National Reference Laboratories

    • Designated by the Department of Health (DOH)
    • Research Institute for Tropical Medicine (RITM): microbiology, parasitology, tuberculosis, transfusion-transmissible infections
    • San Lazaro Hospital STD-AIDS Cooperative Center Laboratory (SACCL): HBV, HIV, HCV, Syphilis, other STIs
    • East Avenue Medical Center (EAMC): drug and water testing
    • National Kidney and Transplant Institute (NKTI): Hematology
    • Lung Center of the Philippines: Clinical Chemistry

    Clinical Laboratories in the Philippines

    • Clinical laboratories operating in the Philippines are subject to the Republic Act No. 4688, the Philippine Regulations on Clinical Laboratories, which provides guidelines for registration, licensing, and penalties for violations.

    • The Philippine Department of Health (DOH) also issued Administrative Order No. 59 s. 2001 and Administrative Order No. 37 s. 2021 to further regulate the registration and operation of clinical labs.

    • Clinical laboratories are categorized by service capability, institutional character, and function.

    Service Capability

    • Clinical laboratories can be classified as primary, secondary or tertiary based on their capability to perform tests.

    • Primary: Routine clinical chemistry and hematology

    • Secondary: Routine clinical chemistry, crossmatching, immunohematology

    • Tertiary: Special chemistry, special hematology, immunology and serology, microbiology

    Institutional Character

    • Clinical laboratories can be categorized as:
    • Institution-based: In hospitals, medical centers, etc
    • Non-institution based: Independent laboratories

    Function

    • Clinical laboratories can be classified by function:
    • Clinical Pathology: Covers clinical chemistry, clinical microscopy, toxicology, therapeutic drug monitoring, immunology and serology, hematology and coagulation, bacteriology, parasitology, mycology, virology
    • Anatomic Pathology: Includes surgical pathology, cytopathology, immunohistochemical techniques, autopsies, and forensic pathology
    • Molecular Pathology: Includes PCR

    Requirements for Permit to Construct and License to Operate

    • A permit to construct a clinical lab must be obtained from the Bureau of Health Facilities and Services (BHFS) before applying for a license to operate.

    • The owner or authorized representative must file a notarized application for a new license or renewal of the license at the BHFS.

    • Applications are reviewed on site by the BHFS to ensure compliance with standards and technical requirements.

    • Failing to comply with requirements can result in the refusal, suspension, or revocation of a license.

    License Fees and Penalties

    • Non-refundable fees are required for the application to construct and license to operate both government and private clinical labs.

    • A renewal fee is required for license renewal.

    • Failure to renew a license on time will incur penalties.

    Key Points of the DOH Regulations

    • All clinical laboratories must provide effective and efficient services.
    • Adequate and appropriate safety practices must be implemented.
    • All clinical laboratories must be monitored regularly by the DOH.

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    Related Documents

    Unit 3.1 Nature of the Clinical Laboratory PDF
    Unit 3.2 Nature of Clinical Laboratory PDF
    Unit 3.3_ Nature of Clinical Laboratory PDF

    Description

    Explore the functions and classifications of clinical laboratories. This quiz covers the differences between government and private laboratories, as well as their institutional roles and testing methods. Test your knowledge on how clinical labs contribute to patient care through accurate analysis.

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