Clinical Laboratory Overview

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.

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.