PMLS LABORATORY

• Clinical Laboratory is the place where specimens (e.g. blood and other body fluids, tissues, feces, hair, nails) collected from individuals are processed, analyzed, preserved, and properly disposed.
• A medical technologist/clinical laboratory scientist plays a very significant role in the performance of laboratory testing and ensuring the reliability of test results.
• Clinical Pathology is a clinical laboratory that focuses on the areas of clinical chemistry, immunohematology and blood banking, medical microbiology, immunology and serology, hematology, parasitology, clinical microscopy, toxicology, therapeutic drug monitoring, and endocrinology, among others.
• Clinical Pathology is concerned with the diagnosis and treatment of diseases performed through laboratory testing of blood and other body fluids.
• Anatomic Pathology is a clinical laboratory specialty that deals with the study of tissues and organs
• Anatomic Pathology is a clinical laboratory that focuses on the areas of histopathology, immunohistopathology, cytology, autopsy, and forensic pathology among others.
• An institution-based is a clinical laboratory that operates within the premises or part of an institution such as a hospital, school, medical clinic, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center, and others.
• A free-standing clinical laboratory is not part of an established institution .
• Government-owned clinical laboratories are owned, wholly or partially, by national or local government units.
• Privately-owned clinical laboratories are owned, established and operated by an individual, corporation, institution, association, or organization.
• Clinical laboratories under the primary category are licensed to perform basic, routine laboratory testing, namely routine urinalysis, routine stool examination routine hematology or complete blood count that includes hemoglobin, hematocrit, WBC and RBC count, WBC differential count and qualitative platelet count, blood typing and gram-staining (if hospital-based). Space requirement is at least 10 square meters.
• Clinical laboratories secondary category (Hospital and non-hospital-based) are licensed to perform laboratory tests being done by the primary category clinical laboratories along with routine clinical chemistry tests like blood glucose concentration blood urea nitrogen, blood uric acid, blood creatinine, cholesterol determination qualitative platelet count, and if hospital-based, Gram stain, KOH mount, and crossmatching. A minimum requirement of 20 square meters is needed for the floor area of this type of laboratory.
• Clinical laboratories under the tertiary category (Hospital and non-hospital based) are licensed to do all types of laboratory tests including those performed by the primary and secondary categories plus immunology and serology (e.g., NS!-Ag for dengue, rapid plasma reagin, treponema pallidum particle agglutination tests); microbiology, bacteriology, and mycology, special clinical chemistry, special hematology, and immunohematology and blood banking. .The minimum floor area required for this type of laboratory is 60 sqm.
• National Reference Laboratory is a laboratory in a government hospital designated by the DOH to provide special diagnostic functions and services for certain diseases. These functions include referral services, provision of confirmatory testing, assistance of the government, resolution of conflicts regarding test results of different laboratories, and training of medical technologists on certain specialized procedures that require standardization.
• Republic Act No. 4688 is also known as Clinical Laboratory Act of 1966.
• Republic Act No. 4688 is an act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the department of health, providing penalty for the violation thereof, and for other purposes.
• Administrative Order No. 59 s. 2001 also known as "Rules and Regulations Governing the Establishment, Operation and Maintenance Of Clinical Laboratories in the Philippines."
• An approved permit to construct and design layout of a clinical laboratory shall be secured form the BHFS prior to submission of an application for a petition to operate.
• A penalty of one thousand pesos for late renewal shall be charged in addition to the renewal fee for all categories if the application is filed during the next 2 months after expiry date.
• An application received more than 2 months after the expiry date shall be fined 100 pesos for each month thereafter in addition to the 1000 pesos penalty.
• INTERNAL QUALITY ASSURANCE SYSTEM (IQAS) • Includes day-to-day activities that are undertaken in order to control factors or variables that may affect test results.
• EXTERNAL QUALITY ASSURANCE SYSTEM (EQAS) • Is a system for checking performance among clinical labs and is facilitated by designed external agencies.
• Internal Quality Control Program - there shall be a documented, continuous competency assessment program for all laboratory personnel.
• External Quality Assurance Program - The laboratory must participate in at least two proficiency testing programs per year
• CLINICAL CHEMISTRY - for the testing of blood and other body fluids to quantify essential soluble chemicals including waste products useful for diagnosis of certain diseases
• MICROBIOLOGY (BACTERIOLOGY, MYCOBACTERIOLOGY, MYCOLOGY, & VIROLOGY) - More focused on the identification of bacteria and fungi on specimens received. Specimens usually submitted are blood and other body fluids, stool, tissues, and swab
• HEMATOLOGY AND COAGULATION STUDIES - Deals with the enumeration of cells in the blood and other body fluids

  Coagulation studies focus on blood testing for the determination of various coagulation factors • Bone marrow examination
• CLINICAL MICROSCOPY - 1st area: routine and other special examinations of urine or urinalysis

  2nd area: the examination of stool or routine fecalysis
• BLOOD BANK/IMMUNOHEMATOLOGY

  Main Activities: Blood Typing and Compatibility testing Screening for all antibodies and identification of antibodies and blood components used for transfusion
• Blood Bank is the most critical section in the clinical laboratory
• IMMUNOLOGY AND SEROLOGY • Analysis of serum antibodies in certain infectious agents
• HISTOPATHOLOGY/CYTOLOGY • Tissue processing, cutting into sections, staining, and preparation for microscopic examination by a pathologist
• IMMUNOHISTOCHEMISTRY - Combines anatomical, clinical, and biochemical techniques where antibodies bounded to enzymes and fluorescent dyes are used to detect presence of antigens in tissue. Useful in the diagnosis of some types of cancers
• MOLECULAR BIOLOGY AND BIOTECHNOLOGY

  • Primarily using different enzymes and other reagents, DNA and RNA are identified and sequenced to detect any pathologic conditions/disease processes

  • Uses Polymerase chain reaction (PCR)
• QUALITY ASSURANCE

  • Ensure reliability of test results

  • Organized, systematic, well-planned, and regularly done with the results properly documented and consistently reviewed