Nature of the Clinical Laboratory PDF

Nature of the Clinical Laboratory Reyanne Faye Buscas Arellano University 6:11PM Learning Outcomes: At the end of this chapter, the students should be able to: 1. Discuss the difference...

Nature of the Clinical Laboratory Reyanne Faye Buscas Arellano University 6:11PM Learning Outcomes: At the end of this chapter, the students should be able to: 1. Discuss the difference sections of the laboratory and the tests done in each; 2. Compare and contrast the different types of clinical laboratories; 3. Identify the salient points of the laws governing the establishment, operations and maintenance of clinical laboratories in the Philippines; and 4. Discuss the importance of quality assurance in the clinical laboratory. Go to next page  What is Clinical Laboratory? The place where specimens collected from individuals are processed, analyzed, preserved, and properly disposed Main task is to provide accurate and reliable information to medical doctors for the Clinical diagnosis, prognosis, treatment, and management of diseases Laboratory 70% of all decisions performed by MD are based on laboratory test results Actively involved in research, community outreach programs, surveillance, infection control in the hospital and community settings, information dissemination, and evaluation of the applicability of current and innovative diagnostic technologies Factors that Can Affect the Activities Done in the Lab 1. Shifting demographics 2. Emergence of new and re-emergence of infectious and non-infectious diseases, 3. Demand for a more efficient and effective workflow 4. New government institutional policies Go to next page Classifications of Clinical Laboratories According to Function 1. Clinical Pathology 2. Anatomic Pathology Concerned with the diagnosis and Concerned with the diagnosis of treatment of diseases performed diseases through through lab testing of blood and other microscopic examination of tissues and body fluids organs Go to next page According to Institutional According to Ownership Characteristics 1. Government-owned 1. Institution-based Clinical labs are owned, wholly, or partially, Operates with the premises or part of an by national or local government units institution (Hospitals, schools, med clinic, medical facilities) Laboratories of DOH-run gov’t hospitals San Lazaro Hospital, Jose R. Reyes Memorial Medical Center, UP-PGH 2. Free-standing Not part of an established institution Local gov’t-run hospital-based clinical labs of Ospital ng Maynila Medical center, Sta. Ana Hospital, and Free-standing out-patient clinical lab is a Bulacan Medical Center common example 2. Privately-owned Owned, established, and operated by an individual, corporation, institution, association, or organization. Go to next page According to Service Capability Go to next page Laws on the Operation, Maintenance and Registration of Clinical Laboratories in the Philippines REPUBLIC ACT NO. 4688: Clinical Laboratory Act of 1966 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. PURPOSE: To protect and promote the health of the people by ensuring availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through compliance with quality standards. Go to next page SECTION 1: shall register and secure a license annualy at the office of the Secretary of Health: provided, that government hospital laboratories doing routine or minimum laboratory examinations shal be exempt from the provisions of this section if their services are extensions of government regional or central laboratories. SECTION 2: It shall be unlawful for any person ot be professional ly in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified ni laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annualy. Go to next page SECTION 3: The Secretary of Health, through the Bureau of Research andLaboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shal be authorized ot issue such rules and regulations as may be necessary ot carry out its provisions. SECTION 4: Any person, firm or corporation who violates any provisions of this Act or hte rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year, or by a fineof not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court. Go to next page SECTION 5: If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof. SECTION 6: The sum of fifty thousand pesos, or so much thereof as may be necessary, si hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act. SECTION 7: All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed. SECTION 8: This Act shall take effect upon its approval. Approved on June 18, 1966 Go to next page ADMINISTRATIVE ORDER NO. 59 s. 2001 “Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines” Created to implement R.A. 4688 Section 1: Title → This Administrative Order shall be known as the "Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines." SECTION 2: Authority → E.O 102 s. 1999: Redirecting the Functions and Operations of the DOH → The DOH, through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster Go to next page SECTION 3: PURPOSE → These rules and regulations are promulgated to protectand promote the health of the people by ensuring availabiliy of clinical laboratories that are properly managed with adequate resources, wih effective and efficient performance through compliance with quality standards. SECTION 4: SCOPE → These regulations shall apply to all entities performing the activities and functions of clinical laboratories which shall include the examination and analysis of any or all samples of human and other related tissues, fluids,secretions, radioactive,or other materials from the human body for the determination of the existence of pathogenic organisms, pathologic processes or conditionsni hte person from whom such samples are obtained. Go to next page SECTION 5: CLASSIFICATION OF LABORATORIES 1) Classification by Function a. Clinical Pathology → includes Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and Therapeutic Drug Monitoring and other similar disciplines. b. Anatomic Pathology → includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy and Forensic Pathology. 2) Classification by Institutional Character a. Hospital-based laboratory- a laboratory that operates within a hospital b. Non-hospital-based laboratory - a laboratory that operates on its own Go to next page 3) Classification by Service Capability Primary ✓ Provides the minimum service capabilities Secondary ✓ Provides minimum service capabilities of a primary category Tertiary ✓ Provides the secondary service capabalities SECTION 6: POLICIES → An approved permit to construct and design layout of a clinical laboratory shall be secured from the BHFS prior to submision of an application for a Petition to Operate. Go to next page SECTION 7: Requirements and Procedures for Application of Permit to Construct and License to Operate → Application for permit to construct ▪ Letter of Application to the BHFS Director ▪ Four sets of Site Development Plans and Floor Plans approved by an architect and/or engineer → Application for new license ▪ Duly notarized form “Petition to Establish, Operate, and Maintain a Clinical Laboratory” filed at the BHFS → Application for renewal of license ▪ Duly notarized form “Petition to Establish, Operate, and Maintain a Clinical Laboratory” filed at respective BHFS ▪ Shall be filed 90 days before the expiry of license Go to next page → Penalties ▪ P1000.00 – late renewal in addition to renewal fee if application is filed during the next 2 months after expiry date ▪ P100 – more than two months after expiry date, addition to P1000 penalty → Terms and Conditions of License ▪ Non-transferrable and granted upon compliance with the licensing requirements ▪ Transfer of clinical laboratory to another location- Inform CHD in writing at least 15 days before actual transfer ▪ The laboratory in its new location shall be subject to re-inspection ▪ An extension laboratory shall have a separate license Go to next page SECTION 8: Violations → Operation of a laboratory without a certified pathologist or without a registered medical technologist SECTION 9: Investigation of Charges or Complaints → Any person found violating the provisions of RA 4688, shall suspend, cancel or revoke for a determined period of time the license, as well as authority of the offending person/s. → Any person who operates a clinical laboratory without proper license from DOH shall upon conviction be subject to imprisonment for not less than 1 month but not more than 1 year OR a fine of no less than P1000 and not more than P5000 or both at the discretion of the court SECTION 10: MODIFICATION AND REVOCATIONOF LICENSE Go to next page SECTION 11: REPEALING CLAUSE → all other previous official issuances hereof. These rules and regulations shal supersede SECTION 12: PUBLICATION AND LIST OFLICENSED CLINICAL LABORATORIES → list of licensed clinical laboratories shall be published annually ni a newspaper of general circulation. SECTION 13: EFFECTIVITY → These rules and regulations shal take effect 51 days after its publication in hte Oficial Gazete, or in anewspaper of general circulation. Go to next page ANNEX A: TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS I. STAFFING 1. The clinical laboratory shall be managed by a licensed physician Philippine Board of Pathology. 2. The clinical laboratory shall employ qualified and adequately train personnel. Work assignment shall be consistent with the qualification of the concerned 3. There shall be saff development and appropriate continuing education program available at all levels of the organization to uprade the knowledge, attitudes and skills of staff. Go to next page II. PHYSICAL FACILITIES 1. The clinical laboratory shall be well- ventilated, adequately 2. The working space shall be sufficient to accommodate its activities and allow for smooth and coordinated work flow. 3. There shall be an adequate water supply personnel 4. The working space for all categories of clinical laboratories (both hospital and non- hospital-based) shall have atleast the following measurements: Go to next page III. EQUIPMENT/INSTRUMENTS 1. There shall be provisions for suficient number equipment/instruments in order to undertake and types of appropriate examinations. This equipmentshall comply with al the activities and laboratory 2. For other laboratory examinations being safety requirements necessary for performing such procedures performed, the appropriate equipment IV. GLASSWARES/REAGENTS/SUPPLIES All categories of clinical laboratories shall provide adequate and appropriate glassware, reagents and supplies necessary to undertake the required services. V. WASTE MANAGEMENT There shall be provisions for adequate and efficient disposal of waste following guidelines of the Department of Health and the local government. Go to next page VI. QUALITY CONTROL PROGRAM All clinical laboratories shall have a functional Quality Assurance Program. VII. REPORTING Laboratory requests shall be construed in consultation between the requesting physician and the Pathologist of the laboratory and such laboratory results shall be released accordingly. VIII. RECORDING There shall be a system of accurate recording to ensure quality results. IX. LABORATORY FEES The laboratory and professional fees to be charged for laboratory examination shall be at the prevailing rates. Go to next page  Sections of the Clinical Laboratory Go to next page  Blood and urine – two most common 1. Clinical Chemistry body fluids tested One of the busiest sections, state-of- the-art, fully automated facility Examples of tests performed: → Fasting Blood Sugar (FBS) → Glycosylated Hemoglobin (HbA1c) – diagnosis of diabetes → HDL and LDL → Triglycerides (TAG) – diagnosis of cardiovascular diseases → HDL and LDL → Blood Uric Acid (BUA) Intended for the testing of blood and other → Blood Urea Nitrogen (BUN) body fluids to quantify essential soluble → Creatinine chemicals including waste products useful for → Total Protein (TP) the diagnosis of certain diseases → Clinical Enzymology Go to next page 2. Microbiology Subdivided into four sections: → Bacteriology – culture (c/s), gram staining (g/s), → KOH → Mycobacteriology – fungal sensitivity and culture → Mycology – fungi identification only → Virology – virus identification Identification of bacteria and fungi on specimens received (usually blood and other fluids, stool, tissues, and swabs from different sites in the body Go to next page 3. Hematology and Coagulation Studies Enumeration of cells in the blood and other body fluids (e.g., CSF, pleural fluid, etc.) Examinations done: → CBC → Hemoglobin → Hematocrit → WBC differential count → Red cell morphology and cell indices → Quantitative platelet count → Total cell count and differential count → Blood smear preparation → Staining for other fluids Go to next page  4. Clinical Microscopy Two major areas: → Examination of stool (routine fecalysis) → Routine and special examination of urine Go to next page  5. Blood bank / Immunohematology Blood typing and compatibility testing – two main activities Other tests performed: → Antibodies screening and identification, blood components for transfusion If hospital based laboratories: donor recruitment and screening, bleeding of donor, post-donation care Considered as the most critical in the clinical laboratory (faulty cross- matching may cause patient’s death) Go to next page 6. Immunology and ANATOMIC PATHOLOGY Serology 7. Histopathology and Analyses of serum antibodies Cytology in certain infectious agents (primarily viral agents) Tissue processing Antigen and antibodies Cutting into sections testing Staining Antibody screening tests: Preparation of microscopic → Hepatitis B profile tests examination by a pathologist → Serological tests for syphilis → Hepatitis C tests → Dengue fever Go to next page  SPECIALIZED SECTIONS 8. Immunohistochemistry 9. Molecular Biology and Combines anatomical, clinical, and Biotechnology biochemical techniques where One of the exciting developments antibodies (monoclonal and in medical technology polyclonal) bounded to enzymes and DNA & RNA identification and dyes are used to detect presence of detection of any pathologic antigens in tissue conditions/disease (enzymes and → Useful in diagnosis of some types of reagent are used) cancers and certain neurodegenerative Polymerase chain reaction (PCR) disorders, and assessment of patients’ – most common technique responses to cancer therapy currently in use Go to next page  LABORATORY TESTING CYCLE Encompasses all activities PRE-ANALYTIC PHASE starting from a medical 1. Laboratory Test Order/Requisition doctor writing a laboratory Variables that may affect test results/cause errors may include: request up to the time (turn- 2. Order Reception around time [TAT]) the 3. Patient Preparation results are generated for 4. Specimen Collection treatment and management 5. Specimen transport and Processing of patients. Medical technologists should ANALYTIC PHASE POST-ANALYTIC PHASE have a clear understanding Looks into the control of the 6. Actual Testing of the testing cycle to Major sources of variables variables of TAT and transcription prevent erroneous test include: errors (e.g. wrong value used, results → Equipment and instruments results given to the wrong He has three phases: Pre- → Quality or reagents used patient) analytic, analytic, and post- → Internal quality control program 7. Data Transmission/interpretation 8. Results Application analytic 9. Turn-Around Time (TAT) Quality Assurance in Encompasses all activities performed by laboratory the Clinical personnel to ensure Laboratory reliability of test results Is organized, systematic, well-planned, and regularly done with the results properly documented and consistently reviewed Go back to next page Internal Includes day-to-day Quality activities that are Assurance undertaken in order to System control factors or (IQAS) variables that may affect test results (e.g. regular review and audit of results) External System for checking Quality performance among Assurance clinical laboratories and is facilitated by System designated external (EQAS) agencies National Reference Laboratories (NRL) – DOH-designated EQAS  Designated NRL-EQAS at present: External → National Kidney and Transplant Institute (NKTI) – Hematology and Coagulation Quality → Research Institute of Tropical Medicine (RITM) – Assurance Microbiology (identification and antibiotic susceptibility testing) and Parasitology (ova System identification and quantitation of malaria) (EQAS) → Lung Center of the Philippines – Clinical Chemistry → East Avenue Medical Center – Drugs of abuse → San Lazaro Hospital STD-AIDS Cooperative Laboratory (SACCL) – Infectious immunology hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV), hepatitis C virus (HCV) Thank you!