Clinical Laboratories Overview
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Clinical Laboratories Overview

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Questions and Answers

What is one main function of a clinical laboratory?

  • To process and analyze specimens (correct)
  • To provide educational courses for medical students
  • To conduct surgery on patients
  • To design medical equipment and devices

    • Which of the following is NOT a characteristic of automated clinical laboratories?

  • More efficient processing
  • Shortened turnaround time (TAT)
  • Less reliable results (correct)
  • Less laborious

    • According to the classification based on ownership, which laboratory is an example of a private clinical laboratory?

  • Philippine General Hospital
  • St. Elizabeth Hospital (correct)
  • Local Government Medical Center
  • National Kidney and Transplant Institute

    • What are the phases involved in the clinical laboratory testing cycle?

    <p>Pre-analytical, analytical, and post-analytical</p> Signup and view all the answers

    Which section of the clinical laboratory would handle blood glucose testing?

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

    What aspect of clinical laboratories is governed by DOH Administrative Order No. 2021-0037?

    <p>Classification based on ownership</p> Signup and view all the answers

    Which of the following specimens would typically be processed in a clinical laboratory?

    <p>Whole blood</p> Signup and view all the answers

    What does 'turnaround time (TAT)' refer to in a clinical laboratory context?

    <p>The duration from specimen collection to result reporting</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 responsibility of the National Reference Laboratory?

    <p>Train medical doctors for clinical practice</p> Signup and view all the answers

    What is included under the Limited Services category in clinical laboratories?

    <p>Social hygiene clinics</p> Signup and view all the answers

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

    <p>20 square meters</p> Signup and view all the answers

    Which category of clinical laboratories is specifically designated by the Department of Health?

    <p>National Reference Laboratories</p> Signup and view all the answers

    What distinguishes a non-institution based clinical laboratory?

    <p>It operates independently from any DOH licensed health facility.</p> Signup and view all the answers

    Which type of laboratory focuses on the analysis of blood and other body fluids?

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

    Which analysis is performed specifically by anatomic pathology?

    <p>Surgical specimen examination</p> Signup and view all the answers

    Which of the following is NOT a function of clinical pathology?

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

    Which type of laboratory is specifically for molecular pathology?

    <p>Clinical Laboratory for Molecular Pathology ONLY</p> Signup and view all the answers

    What kind of analyses are performed in toxicology within clinical pathology?

    <p>Analysis of bodily fluids for drugs and poisons</p> Signup and view all the answers

    Which of the following options does NOT represent a type of pathology covered under clinical or anatomical pathology?

    <p>Family medicine</p> Signup and view all the answers

    Molecular pathology is primarily concerned with which type of analysis?

    <p>Analysis of genetic materials and proteins</p> Signup and view all the answers

    What is the primary purpose 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 the clinical chemistry laboratory?

    <p>HBA1C</p> Signup and view all the answers

    What phase of laboratory testing includes the receipt of laboratory requests and patient preparation?

    <p>Pre-analytical Phase</p> Signup and view all the answers

    Which of the following factors can affect test results during the pre-analytical phase?

    <p>Caffeine intake</p> Signup and view all the answers

    What are the two major components of quality assurance in the clinical laboratory?

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

    Which of the following is a variable that may affect test results during the pre-analytical phase?

    <p>Underlying disease conditions</p> Signup and view all the answers

    Which national reference laboratory focuses on drug and water testing?

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

    What does the acronym EQAS stand for in the context of national reference laboratories?

    <p>External Quality Assessment Schemes</p> Signup and view all the answers

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

    <p>Identifying microorganisms and conducting susceptibility testing.</p> Signup and view all the answers

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

    <p>Daily activities to control test result variables.</p> Signup and view all the answers

    Which test would typically be performed in the Clinical Chemistry section of a laboratory?

    <p>Creatinine measurement.</p> Signup and view all the answers

    What is a key characteristic of the Blood Bank/Immunohematology section?

    <p>Compatibility testing for blood transfusions.</p> Signup and view all the answers

    Which of the following is a component of the External Quality Assurance System (EQAS)?

    <p>Participation in competitive performance evaluations.</p> Signup and view all the answers

    What is profoundly utilized in the Histopathology/Cytology section of the laboratory?

    <p>Microscopic examination of stained tissue sections.</p> Signup and view all the answers

    Which phase of laboratory testing involves the actual testing of specimens?

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

    What type of analyses does the Molecular Biology and Biotechnology section focus on?

    <p>DNA and RNA analysis using enzymes.</p> Signup and view all the answers

    What is one of the major roles of the Clinical Chemistry section?

    <p>Testing blood and body fluids for chemical levels.</p> Signup and view all the answers

    Which test is commonly conducted in the Immunology and Serology section?

    <p>Hepatitis B profile tests.</p> Signup and view all the answers

    What is a primary focus of the Clinical Microscopy section?

    <p>Examinations of urine and stool samples.</p> Signup and view all the answers

    Which section of the clinical laboratory is responsible for identifying antigens in tissue?

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

    What is a critical activity included in the Quality Assurance process of a clinical laboratory?

    <p>Verification of test results through audits.</p> Signup and view all the answers

    What is the primary objective of the Clinical Laboratory Law of 1966 in the Philippines?

    <p>To ensure the health of the general public by preventing substandard laboratories.</p> Signup and view all the answers

    Which of the following statements is true regarding Republic Act 4688?

    <p>It requires the registration of clinical laboratories with the Department of Health.</p> Signup and view all the answers

    Which aspect is NOT covered under the regulation of clinical laboratories in the Philippines?

    <p>Marketing strategies for laboratory services.</p> Signup and view all the answers

    What is a primary focus of the Ministry of Health regarding clinical laboratories?

    <p>To assess and ensure compliance with laboratory regulations.</p> Signup and view all the answers

    What does the Clinical Laboratory Law of 1966 primarily aim to prevent?

    <p>The operation of clinical laboratories without a license.</p> Signup and view all the answers

    What is a requirement to obtain a permit for constructing a clinical laboratory?

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

    Which category of clinical laboratories includes immunology and serology?

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

    What is NOT a policy requirement for clinical laboratories under DOH regulations?

    <p>Acquisition of a certified laboratory manager</p> Signup and view all the answers

    What must occur before starting the construction of a clinical laboratory?

    <p>Issuance of a construction permit by the BHFS</p> Signup and view all the answers

    Which of the following does NOT fall under the secondary category of clinical laboratory services?

    <p>Special hematology</p> Signup and view all the answers

    What classification category focuses primarily on the testing of tissues and samples taken during surgeries?

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

    Which of the following procedures falls under clinical pathology?

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

    What characteristic differentiates non-institution based laboratories from institution-based laboratories?

    <p>Ownership structure</p> Signup and view all the answers

    Which category includes primarily clinical laboratories that provide both clinical and anatomic pathology services?

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

    What is one primary consideration in determining laboratory fees?

    <p>Prevailing usual fees</p> Signup and view all the answers

    Which of the following is NOT covered under clinical pathology services?

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

    Which testing method is specifically associated with molecular pathology?

    <p>Polymerase Chain Reaction (PCR)</p> Signup and view all the answers

    What is a key factor that should not be included in the laboratory fee?

    <p>Professional service charges</p> Signup and view all the answers

    What is the frequency of renewal for a Certificate of Registration (COR) for clinical laboratories operated exclusively for research and teaching purposes?

    <p>Every three years</p> Signup and view all the answers

    What occurs immediately if a clinical laboratory is found to be in violation during a monitoring visit?

    <p>Preventive suspension may be imposed</p> Signup and view all the answers

    What is the first sanction for non-institution based clinical laboratories upon their first offense?

    <p>Stern warning</p> Signup and view all the answers

    What is the purpose of the non-refundable application fee when applying for a Certificate of Registration?

    <p>To cover administrative costs</p> Signup and view all the answers

    Which of the following is NOT a requirement for applying for a Certificate of Registration?

    <p>Possessing a current DOH-LTO</p> Signup and view all the answers

    What type of clinical laboratories are subject to sanctions based on Administrative Order No. 2007-0022?

    <p>Institution-based clinical laboratories</p> Signup and view all the answers

    What is a potential consequence for a third offense by non-institution based clinical laboratories?

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

    What is the primary role of HFSRB in relation to clinical laboratories?

    <p>Conduct inspections and monitor compliance</p> Signup and view all the answers

    What penalty is imposed if an institution fails to pay imposed fines within 10 working days?

    <p>A surcharge of 3% of total fines for each month delayed</p> Signup and view all the answers

    What is the administrative penalty for operating without a DOH-PTC and DOH-LTO?

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

    What consequence faces a clinical laboratory after a fourth violation?

    <p>Suspension or revocation of license</p> Signup and view all the answers

    After a revocation of a clinic license, how long must a lab wait to reapply?

    <p>1 year</p> Signup and view all the answers

    What happens if a clinical laboratory issues false test results knowingly?

    <p>They cannot own or operate any DOH-licensed lab</p> Signup and view all the answers

    What is the penalty percentage for each subsequent violation after the second violation?

    <p>20% of the previous fine</p> Signup and view all the answers

    What must a clinical laboratory do if they wish to appeal a decision made by HFSRB/CHD-RLED?

    <p>Submit a notice of appeal within 10 days</p> Signup and view all the answers

    What additional fine is imposed for the failure to pay a fine after its due date?

    <p>3% of the total fines monthly</p> Signup and view all the answers

    What is a necessary component of the Internal Quality Control Program for laboratory personnel?

    <p>Documented continuous competency assessment</p> Signup and view all the answers

    Which of the following is required for the renewal of a laboratory license?

    <p>Satisfactory performance rating from a designated NRL</p> Signup and view all the answers

    What must all laboratory reports include?

    <p>The names of the RMT and the Pathologist, signed by both</p> Signup and view all the answers

    What is the minimum retention period for laboratory records, excluding anatomic and forensic pathology records?

    <p>One year</p> Signup and view all the answers

    What consequence does refusal to participate in EQAP have for a laboratory?

    <p>Possible suspension or revocation of the laboratory's license</p> Signup and view all the answers

    Which element is NOT part of the Internal Quality Control Program?

    <p>External validation from professional organizations</p> Signup and view all the answers

    What should participants in an external quality assurance program expect?

    <p>Regular performance assessments by designated NRL</p> Signup and view all the answers

    What is a significant requirement for issuing laboratory reports?

    <p>Authorization from the Pathologist or their associate</p> Signup and view all the answers

    What must a clinical laboratory do if it is found non-compliant during the on-site assessment?

    <p>Address deficiencies within thirty days</p> Signup and view all the answers

    What happens if a complete application is not processed within twenty days due to force majeure?

    <p>The laboratory is granted the license to operate</p> Signup and view all the answers

    Which of the following is NOT a requirement for obtaining a license to operate a clinical laboratory?

    <p>Operational budget for the first year</p> Signup and view all the answers

    What must be done if there is a change in management or ownership of a laboratory?

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

    When must a laboratory display its DOH-LTO?

    <p>In an area that is visible to the public at all times</p> Signup and view all the answers

    What is required for different branches of a clinical laboratory owned by the same entity?

    <p>Each branch must secure a separate DOH-LTO</p> Signup and view all the answers

    What could be the consequence of failing to notify the HFSRB/CHD-RLED of substantial changes in the laboratory?

    <p>Suspension or revocation of the DOH-LTO</p> Signup and view all the answers

    What document must be included as part of the complete application for obtaining a DOH-LTO?

    <p>Health facility geographic form</p> Signup and view all the answers

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

    <p>10 sq.m.</p> Signup and view all the answers

    What is a necessary qualification for a physician managing a clinical laboratory in areas without pathologists?

    <p>Three months training in clinical laboratory medicine</p> Signup and view all the answers

    What is the primary focus of the staffing requirements in clinical laboratories?

    <p>Qualified and adequately trained personnel</p> Signup and view all the answers

    How many registered medical technologists (RMTs) are required at a minimum for a hospital-based clinical laboratory during each shift?

    <p>One RMT</p> Signup and view all the answers

    What is a necessary requirement for the physical facilities of a clinical laboratory?

    <p>Clean, well ventilated, and adequately lighted</p> Signup and view all the answers

    Which of the following is NOT included in the minimum requirements for laboratory equipment?

    <p>Advanced automated systems</p> Signup and view all the answers

    What is the primary purpose of the staff development program in clinical laboratories?

    <p>To ensure continuing education at all levels</p> Signup and view all the answers

    Which of the following statements correctly describes waste management in clinical laboratories?

    <p>Provisions for efficient disposal following guidelines are required</p> Signup and view all the answers

    What must be submitted for a new license to operate a clinical laboratory?

    <p>A duly notarized application form</p> Signup and view all the answers

    When should a renewal application for a license to operate a clinical laboratory be filed in the NCR?

    <p>At least 90 days before expiration</p> Signup and view all the answers

    What is the penalty for not renewing a license within 2 months after the expiry date?

    <p>A Php1,000.00 penalty</p> Signup and view all the answers

    How often must inspections be performed on clinical laboratories?

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

    What is required to transfer a license for a clinical laboratory to another location?

    <p>Written notification to the CHD at least 15 days prior</p> Signup and view all the answers

    What is the consequence of operating a clinical laboratory without a valid license?

    <p>Immediate closure by health authorities</p> Signup and view all the answers

    What type of fee is applied for the application to construct a clinical laboratory?

    <p>Non-refundable license fee</p> Signup and view all the answers

    What must licensed clinical laboratories provide for monitoring by authorized representatives?

    <p>Records for compliance with regulations</p> Signup and view all the answers

    Which of the following conditions is NOT associated with the issuance of a clinical laboratory license?

    <p>Must operate with a private partnership</p> Signup and view all the answers

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

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

    What can cause the revocation of a clinical laboratory's license?

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

    Which action would NOT be considered a violation by a clinical laboratory?

    <p>Conducting inspections during normal business hours</p> Signup and view all the answers

    What is the potential penalty for operating a clinical laboratory without a proper license?

    <p>Imprisonment for 1 month to 1 year</p> Signup and view all the answers

    Which condition must be met for the modification or revocation of a clinical laboratory's license?

    <p>Prior notice and investigation must be conducted</p> Signup and view all the answers

    Which entity holds the authority to report unlicensed clinical laboratories?

    <p>Municipal health officers</p> Signup and view all the answers

    What must happen if a laboratory's license is revoked?

    <p>The laboratory will be required to close immediately</p> Signup and view all the answers

    What is classified as a gross negligence violation for a clinical laboratory?

    <p>Improper storage of hazardous materials</p> Signup and view all the answers

    What occurs if a clinical laboratory refuses inspection by authorized personnel?

    <p>This action can be classified as a violation</p> Signup and view all the answers

    What are the consequences of any act deemed detrimental to the public by a clinical laboratory?

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

    What is required for change in ownership or personnel in a clinical laboratory?

    <p>Formal notice to the Department of Health</p> Signup and view all the answers

    Which of the following tests is NOT typically performed in the clinical chemistry section?

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

    Which phase in laboratory testing is characterized by patient preparation and request receipt?

    <p>Pre-analytical Phase</p> Signup and view all the answers

    What is one major component of quality assurance in clinical laboratories?

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

    Which physiological factor can significantly impact test results during the pre-analytical phase?

    <p>Time of day</p> Signup and view all the answers

    Which of the following national reference laboratories primarily focuses on Clinical Chemistry?

    <p>Lung Center of the Philippines</p> Signup and view all the answers

    Which variable related to patient preparation is crucial for accurate testing outcomes?

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

    Which test is associated with measuring blood urea nitrogen levels?

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

    In clinical laboratories, what does EQAS stand for?

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

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

    <p>To check performance among clinical laboratories</p> Signup and view all the answers

    Which type of examination is primarily performed in the Clinical Microscopy section?

    <p>Urine analysis</p> Signup and view all the answers

    What is not typically included in the routine analyses of the Immunology and Serology section?

    <p>Toxicology screening</p> Signup and view all the answers

    Which section of the clinical laboratory deals with antimicrobial susceptibility testing?

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

    What does the Analytical Phase of the laboratory testing cycle primarily involve?

    <p>Actual testing of specimens</p> Signup and view all the answers

    Which of the following disorders is primarily diagnosed using Immunohistochemistry?

    <p>Neurodegenerative disorders</p> Signup and view all the answers

    Which test is a common analysis performed in the Hematology and Coagulation Studies section?

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

    What is a key component of the Internal Quality Assurance System (IQAS)?

    <p>Day-to-day activities control</p> Signup and view all the answers

    What type of analyses does the Molecular Biology and Biotechnology section primarily focus on?

    <p>DNA and RNA identification</p> Signup and view all the answers

    Which task is performed in the Histopathology/Cytology section of the clinical laboratory?

    <p>Tissue processing and staining</p> Signup and view all the answers

    What is a critical function of Quality Assurance in the clinical laboratory?

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

    Which test is routinely performed to assess blood compatibility in the Blood Bank/Immunohematology section?

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

    What is the primary focus of the Clinical Chemistry section?

    <p>Quantification of blood and body fluids' chemicals</p> Signup and view all the answers

    What is the main role of the pre-analytic phase in laboratory testing?

    <p>Preparing specimens for testing</p> Signup and view all the answers

    What does the term 'pre-analytical' refer to in the context of a clinical laboratory?

    <p>It encompasses activities related to specimen collection and preparation.</p> Signup and view all the answers

    Which type of analysis focuses on the study of tissues and cells?

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

    Which of the following best describes the role of quality assurance in a clinical laboratory?

    <p>Monitoring all phases of the testing process for accuracy.</p> Signup and view all the answers

    What is the minimum floor area required for a clinical laboratory to be classified as tertiary?

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

    Which service is NOT typically provided by a National Reference Laboratory?

    <p>Launch diseases prevention campaigns</p> Signup and view all the answers

    What is a primary function of clinical chemistry laboratories?

    <p>To evaluate biochemical substances in body fluids.</p> Signup and view all the answers

    What aspect distinguishes a private clinical laboratory from a government-operated one?

    <p>The operational funding source.</p> Signup and view all the answers

    Which is a characteristic of a clinical laboratory categorized under Limited Services?

    <p>Can include dialysis centers</p> Signup and view all the answers

    What is the main function of a clinical laboratory for Clinical and Anatomic Pathology?

    <p>Perform anatomical and clinical analyses</p> Signup and view all the answers

    Which section of a clinical laboratory is primarily responsible for the detection of infectious agents?

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

    What distinguishes a secondary category clinical laboratory from others?

    <p>It requires a minimum floor area of 20 square meters.</p> Signup and view all the answers

    Which category of clinical laboratories is likely to offer services related to endocrinology?

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

    Which element reflects an automated clinical laboratory's advantage over a manual one?

    <p>Reduced human error and reliable results.</p> Signup and view all the answers

    Which classification of clinical laboratories describes those located within a Department of Health licensed health facility?

    <p>Institution based laboratories</p> Signup and view all the answers

    What type of analysis is typically performed in the Clinical Pathology section?

    <p>Chemical and cellular analyses of blood</p> Signup and view all the answers

    Which is NOT included in the functions of Anatomic Pathology?

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

    What is the primary focus of Molecular Pathology?

    <p>Analysis of genes and proteins</p> Signup and view all the answers

    How is Clinical Laboratory for Anatomy Pathology exclusively defined?

    <p>Does not provide any laboratory for clinical pathology</p> Signup and view all the answers

    Which of the following represents a service capability of clinical laboratories?

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

    Which analysis is specifically associated with Clinical Microbiology?

    <p>Identification of microbes and parasites</p> Signup and view all the answers

    What is a key service not typically offered by a Clinical Laboratory for Molecular Pathology?

    <p>Therapeutic drug monitoring</p> Signup and view all the answers

    Study Notes

    What is a Clinical Laboratory?

    • A clinical laboratory is a facility that provides accurate and reliable results by processing, analyzing, preserving, and properly disposing of specimens
    • Specimens include whole blood, serum, plasma, urine, stool, etc.
    • Clinical laboratories vary in size, function, and the complexity of tests performed.

    Clinical Laboratory Types

    • Manual: Taxing, labor intensive, time-consuming
    • Automated: Less laborious, shortened turnaround time, more reliable results

    Classification of Clinical Laboratories

    • Based on Ownership:
      • Government: Operated and maintained by the national government (e.g., San Lazaro Hospital, UP-PGH)
      • Private: Privately owned (e.g., St. Elizabeth Hospital (MediLinx Laboratory), Vitalab)
    • Based on Institutional Character:
      • Institution Based: Laboratory located within the premises and operates as part of a DOH licensed health facility
      • Non-Institution Based: Laboratory that operates independently and is not attached to any DOH licensed health facility
    • Based on Function:
      • Clinical Pathology: Chemical and cellular analyses of blood and other body fluids, identifications and examination of microbes and parasites
        • 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
        • Surgical pathology
        • Cytopathology
        • Immunohistochemical techniques
        • Autopsies
        • Forensic pathology
      • Molecular Pathology: Analysis of certain genes, proteins, and other molecules in samples from organs, tissues or body fluids
    • Based on Service Capability:
      • Clinical Laboratory for Clinical and Anatomic Pathology:
        • Primary Category: Minimum of 10 square meters in floor area.
        • Secondary Category: Minimum of 20 square meters in floor area.
        • Tertiary Category: Minimum of 60 square meters in floor area.
        • Limited Services: Dialysis centers, Social hygiene clinics
      • Clinical Laboratory for Anatomic Pathology Only
      • Clinical Laboratory for Molecular Pathology Only
      • National Reference Laboratory:
        • Located in a Government Hospital (e.g., RITM)
        • Designated by DOH
        • Provides special diagnostic functions and services for certain diseases
        • Provides laboratory reference/referral services for confirmatory testing
        • Trains laboratory personnel and recognizes other training institutions
        • Maintains the national external quality assessment schemes
        • Performs technical evaluation of reagents and diagnostic kits

    DOH Administrative Order No. 2021-0037

    • This regulation governs the operation of clinical laboratories in the Philippines.
    • Focuses on pre-analytical, analytical, and post-analytical procedures, covering specimens from the human body.
    • It outlines requirements for different types of clinical laboratories.

    Philippine Regulations on Clinical Laboratories

    • The Clinical Laboratory law of the Philippines is Republic Act No. 4688, or the Clinical Laboratory Law of 1966.
    • The law was approved on June 18, 1966.
    • The law aims to ensure the health of the general public by preventing the operation of substandard laboratories.
    • The law requires registration of clinical laboratories with the Department of Health (DOH).
    • The DOH Administrative Order No. 59 s. 2001, classifies clinical laboratories by service capability:
      • Secondary Category: includes routine clinical chemistry and crossmatching
      • Tertiary Category: includes several special sections:
        • Special Chemistry
        • Special Hematology
        • Immunology and Serology
        • Microbiology
    • The DOH Administrative Order No. 59 s. 2001 further outlines policies, requirements for permits, and licensing:
      • A permit to construct and design layout of a clinical laboratory is required from the Bureau of Health Facilities and Services (BHFS).
      • Construction starts after the plans are approved and the BHFS issues a construction permit.
      • The laboratory must operate with a valid license issued by the BHFS/CHD.
    • The DOH Administrative Order No. 37 s. 2021 further outlines policies, requirements for permits, and licensing:
      • The Order classifies clinical laboratories by:
        • Function:
          • Clinical Pathology: services include clinical chemistry, clinical microscopy, toxicology, therapeutic drug monitoring, immunology and serology, hematology and coagulation, bacteriology, parasitology, mycology, virology.
          • Anatomic Pathology: services include surgical pathology, cytopathology, immunohistochemical techniques, autopsies, forensic pathology.
          • Molecular Pathology: services include PCR.
        • Institutional Character:
          • Institution-Based
          • Non-Institution Based
        • Service Capability:
          • Clinical Laboratory for Clinical and Anatomic Pathology
          • Clinical Laboratory for Anatomic Pathology ONLY
      • A Certificate of Registration (COR) is required for research and teaching laboratories and must be renewed every 3 years.
      • The DOH-LTO (License to Operate) for clinical laboratories is valid for one year.
      • The HFSRB (Health Facilities and Services Regulatory Board) / CHD-RLED (Center for Health Development - Regional Licensing and Enforcement Division) may conduct unannounced on-site visits of licensed CL and registered research and teaching laboratories to monitor compliance with standards.
      • Laboratories should not issue official results if they are operated and maintained for research and teaching.

    Violations, Sanctions, and Appeal

    • The penalties for violations are different for non-institution based CL and institution based CL:
      • Non-institution based CL: receive progressive penalties for repeated violations, including fines, and ultimately revocation of the DOH-LTO.
      • Institution based CL: penalties are based on AO No. 2007-0022, and include fines and potential suspension or revocation of the license.
      • Any person operating a CL without a DOH-PTC (Permit to Construct) and DOH-LTO will be issued a Cease and Desist Order and pay a fine of Php 50,000.
      • Complaints regarding CLs are investigated and a CL may be preventively suspended for up to 60 days depending on the severity of the violation.
      • A CL with a revoked license can only re-apply for a license after 1 year from the date of revocation.
      • Any person authorized or licensed to conduct clinical laboratory tests, who issues false laboratory test results knowingly or through gross negligence, will not be allowed to own, manage, operate, or be an analyst of any DOH-licensed CL.

    Private Clinical Laboratory - Permit to Construct and License to Operate

    • A duly notarized application form for a new clinical laboratory license must be filed with the Bureau of Health Facilities and Services Regulation (BHFS).
    • Renewal of a license is required every two years.
    • Renewal application forms need to be filed with the respective Center for Health Development (CHD).
    • Renewal applications must be filed within 90 days before the license expiry date.
    • There are specific deadlines for different regions of the Philippines.
    • Fees are non-refundable.
    • Late renewal penalties apply, exceeding a PHP 1,000.00 fine beyond the expiry date.
    • Inspections are required every two years or as needed.
    • Records must be available upon request from the BHFS/CHD.
    • Monitoring is ongoing and must be allowed during any time.
    • Licenses are issued only if the application is found to be meritorious.
    • Clinical laboratories must have separate licenses for each branch location.
    • Changes affecting the laboratory, such as ownership or location, must be reported in writing.
    • License must be placed in a visible area.
    • Suspension and revocation of licenses are possible for violations of the rules and regulations.
    • Violations include operating without a certified pathologist or registered medical technologist, change of ownership without informing the BHFS/CHD, refusal of inspections.
    • Provincial, city, and municipal health officers are responsible for reporting any unlicensed laboratories.
    • Offenders face imprisonment and/or fines.
    • Closure orders can be issued for laboratories operating illegally.
    • Closure orders can't be overturned by legal injunction.
    • Licenses can be revoked for false statements or violation of the regulations.
    • Licenses can't be legally modified, suspended, or revoked without a prior notice and investigation.

    Technical Standards and Minimum Requirements for Private Clinical Laboratories

    • Must be managed by a licensed physician certified by the Philippine Board of Pathology.
    • In areas without pathologists, a physician with a specific training certificate on clinical laboratory medicine, quality control, and laboratory management can manage a primary or secondary category laboratory.
    • Adequately trained staff are required.
    • Minimum staff ratios are required, with at least one registered medical technologist per shift for hospital-based clinical laboratories.
    • Staff development and continuing education programs are mandated.
    • Physical facilities must be well-ventilated, clean, and safe.
    • Minimum area requirements vary:
      • Primary category: 10 square meters.
      • Secondary category: 20 square meters.
      • Tertiary category: 60 square meters.
    • Sufficient equipment and instruments are required for all tests performed.
    • Safety requirements apply to equipment.
    • Glassware, reagents, and supplies must be adequate.
    • Waste management protocols must be followed.

    Quality Control Program

    • Internal Quality Control:
      • Documentation of continuous competency assessments for staff.
      • Standardized methods, reagents, supplies, and equipment.
      • Proper maintenance and monitoring of equipment.
      • Use of quality control reference materials.
    • External Quality Control:
      • Participation in an external quality assurance program (EQAP) administered by the National Reference Laboratory.
      • Satisfactory performance rating is required for the renewal of licenses.
      • Refusal to participate in EQAP can result in license suspension/revocation.
      • Laboratory reports must be signed by both the registered medical technologist and the pathologist.
      • Reporting of results must be reviewed and authorized by the pathologist, except in emergencies.
    • Recording:
      • A system for recording requests and reports of all specimens is required.
      • Provisions for filing, storage, and accession of all reports.
      • Laboratory records must be retained for at least one year.
      • Anatomic and forensic pathology records should be kept permanently.

    Licensing Procedures

    • Complete application forms are reviewed and assessed by the HFSRB/CHD-RLED representative.
    • On-site assessments determine compliance with technical requirements.
    • Deficiencies must be addressed within 30 days.
    • LTOs are issued only after full compliance is confirmed.
    • LTOs are not transferable.
    • Notifications must be made in writing about any changes in management, ownership, personnel, or significant laboratory conditions.
    • Different branches of a clinical laboratory must each have a separate LTO.
    • LTO must be placed in a visible area.

    Sections of the Clinical Laboratory

    • Clinical Chemistry: Tests blood and other body fluids to quantify soluble chemicals to diagnose certain 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: Subdivided into bacteriology, mycobacteriology, mycology, and virology.
      • Tests include: Blood culture, antimicrobial susceptibility testing, microscopic visualization of microorganisms and fungi, biochemical tests, antigen typing, antibacterial susceptibility tests, preparation of culture media and stains.
      • Focuses on quality control and assurance, infection control, biosafety, proper waste disposal.
    • Hematology and Coagulation Studies: Enumeration of cells in the blood and other body fluids.
      • Tests include: Complete blood count, hemoglobin, hematocrit, WBC differential count, red cell morphology and indices, quantitative platelet count, total cell count and differential count, blood smear preparation, staining of other body fluids.
    • Clinical Microscopy: Two major areas of focus - examination of urine and stool.
      • Tests include: Macroscopic examinations, microscopic examinations, biochemical determinations, detection and identification of parasitic worms and ova.
    • Blood Bank/Immunohematology: Enumeration of cells in the blood and other body fluids. Most critical section.
      • Tests include: Blood typing, compatibility testing, blood components for transfusion.
    • Immunology and Serology: Analyses of serum antibodies in certain infectious agents, primarily viral agents.
      • Tests include: Hepatitis B profile tests, serological tests for syphilis, hepatitis C, dengue fever.
    • Histopathology/Cytology: Tissue processing, cutting into sections, staining and preparation for microscopic examination.
    • Immunohistochemistry: Combines anatomical, clinical and biochemical techniques. Antibodies bound to enzymes and fluorescent dyes detect antigens in tissues.
      • Tests include: Tumor specific antigens, oncogenes, tumor suppressor genes.
    • Molecular Biology and Biotechnology: DNA and RNA identified using enzymes and other reagents.
      • Tests include: Polymerase chain reaction.

    The Laboratory Testing Cycle

    • Three phases: Pre-analytic, Analytic, and Post-analytic.
    • Pre-analytic: Laboratory test requisition/order, order reception, patient preparation, specimen collection, specimen transport and processing.
    • Analytic: Actual testing.
    • Post-analytic: Data transmission/interpretation, results application, turn-around time (TAT).

    Quality Assurance in the Clinical Laboratory

    • All activities performed by laboratory personnel to ensure reliability of test results.
    • Two components: Internal Quality Assurance System (IQAS) and External Quality Assurance System (EQAS).
    • IQAS: Day-to-day activities to control factors that may affect test results.
    • EQAS: System for checking performance among clinical laboratories facilitated by external agencies.
    • National Reference Laboratory is the DOH designated EQAS.

    External Quality Assessment Scheme

    • Evaluates the performance of participating laboratories.
    • Required under local regulatory policies for securing a license.

    National Reference Laboratories

    • 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 Laboratory Overview

    • A clinical laboratory provides accurate and reliable results by processing, analyzing, preserving and disposing of specimens like blood, urine, and stool.
    • Laboratories vary in size, function, and complexity of tests performed.
    • They operate with pre-analytical, analytical, and post-analytical procedures involving specimens from the human body.
    • Clinical laboratories are split into various sections including anatomic pathology, clinical chemistry, clinical microscopy, endocrinology, hematology, immunology and serology, microbiology, toxicology, molecular and nuclear diagnostics.

    Classification of Clinical Laboratories

    • Laboratories are classified by ownership (government or private), institutional character (institution-based or non-institution based), and function.

    Ownership

    • Government: Operated and maintained by the government (ex: San Lazaro Hospital, UP-PGH)
    • Private: Privately owned (ex: St Elizabeth Hospital, MediLinx Laboratory, Vitalab)

    Institutional Character

    • Institution-based: Situated within a DOH licensed health facility and operates as a department (ex: hospital laboratory).
    • Non-institution-based: Operates independently and is not attached to any DOH licensed health facility (ex: independent lab).

    Function

    • Clinical Pathology: Processes and analyzes chemical and cellular components of blood and other body fluids, identifies and examines microbes and parasites.
      • Includes clinical chemistry, clinical microscopy, toxicology, therapeutic drug monitoring, immunology and serology, hematology and coagulation, bacteriology, parasitology, mycology, and virology.
    • Anatomic Pathology: Examines surgical specimens
    • Includes surgical pathology, cytopathology, immunohistochemical techniques, autopsies, and forensic pathology.
    • Molecular Pathology: Analyses genes, proteins, and other molecules in samples from organs, tissues, or body fluids.

    Service Capability

    • A. Clinical Laboratory for Clinical and Anatomic Pathology: Offers both clinical and anatomic pathology services.
      • Primary Category: Minimum floor area of 10 square meters.
      • Secondary Category: Minimum floor area of 20 square meters.
      • Tertiary Category: Minimum floor area of 60 square meters.
      • Limited Services: For dialysis centers and social hygiene clinics.
    • B. Clinical Laboratory for Anatomy Pathology ONLY: Focuses solely on anatomic pathology services.
    • C. Clinical Laboratory for Molecular Pathology ONLY: Focuses solely on molecular pathology services.

    National Reference Laboratory (NRL)

    • Designated by DOH as a laboratory within a government hospital.
    • Performs special diagnostic functions and services for certain diseases.
    • Provides laboratory reference and referral services for confirmatory testing.
    • Trains laboratory personnel and recognizes other training institutions.
    • Maintains the national external quality assessment scheme.
    • Conducts technical evaluations of reagents and diagnostic kits.

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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 diverse types and classifications of clinical laboratories in this informative quiz. Learn about the differences between manual and automated labs, as well as public versus private ownership. Test your knowledge on specimen types and the functionalities of clinical laboratories.

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