LESSON 9: NATURE OF CLINICAL LABORATORY

• THE CLINICAL LABORATORY


  *Essential component of health institutionsIts main task is to provide accurate and reliable information to medical doctors for the diagnosis,prognosis, treatment, and management of diseases.*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 innovativediagnostic technologies.Place where specimens (e.g. blood and other bodyfluids, tissues, feces, hair and nails) collected areprocessed, analyzed, preserved and properly disposed
• Integral partner of the doctors;


  important member ofthe health care delivery system.
• With AUTOMATION:

  less laborious w/ shortenedturnaround time (TAT)
• CLINICAL PATHOLOGY:

  Diagnosis and treatment of diseases performed through laboratory testing of blood and other body fluids
• ANATOMIC PATHOLOGY:


  Diagnosis of diseases through microscopic examination of tissues and organs
• INSTITUTION-BASED:


  Is a clinical laboratory that operates within premises or part of an institution or part of an institution
• 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
• PRIMARY CATEGORY :at least 10 sq.meters


  are licensed to perform basic, routine laboratory testing, namely.
• SECONDARY CATEGORY: (HOSPITAL AND NON-HOSPITAL BASED) 20 sq.meters


  are licensed to perform laboratory tests being done by the primary category clinical laboratories with routine clinical chemistry tests.
• TERTIARY CATEGORY : (HOSPITAL AND NON- HOSPITAL BASED) 60 sq.meters

  ALL laboratory tests in the secondary category plus:
• NATIONAL REFERENCE LABORATORY:


  Is a laboratory in a government hospital designated by the DOH to provide special diagnostic functions and services for certain diseases.*Training of MTs on certain specialized procedures that require standardization
• R.A. 4688-


  *Clinical Laboratory Act of 1966An 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 otherpurposesApproved: June 18, 1966.
• A.O. 59 s. 2001

  "Rules and Regulation Governing the Establishment,Operation and Maintenance of Clinical Laboratories in the Philippines"
• Section 1.


  shall register and secure a license annually at the office of the Secretary of Healt
• Section 2.


  It shall be unlawfulunless he is a licensed physician duly qualified in laboratory medicine
• Section 3.


  The Secretary of Health, through the Bureau of Research and Laboratoriesshall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules
• Section 4.


  who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment
• Section 5

  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.


  sum of fifty thousand pesos, or so mush thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury
• Section 7.


  which are inconsistent with the provisions of this Act are hereby repealed.
• Section 8.

  Act shall take effect upon its approval.
• Section 1 Title.


  This Administrative Order shall be knownas the "Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines.
• Section 2 Authority.


  are issued to implement R.A. 4688: Clinical Laboratory Law consistent with E.O. 102 series 1999:*Redirecting the Functions and Operations of the Department of Health.through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions under these rules and regulations.
• Section 3 Purpose.

  are promulgated 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.
• Section 4 Scope.


  shall apply to all entities performing the activities and functions of clinical laboratorieswhich 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 bodyregulations do not include government laboratories doing laboratory examinations
• Clinical Pathology (Classification by Function)

  includes Hematology, ClinicalChemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and Therapeutic Drug Monitoring and other similar disciplines.
• Anatomic pathology (Classification by Function)

  includes Pathology, Immunohistopathology, Autopsy and Forensic Pathology.Surgical Cytology,
• Hospital-based laboratory


  – a laboratory thatoperates within a hospital.
• Non-hospital-based laboratory


  -a laboratory thatoperates on its own.
• Section 6 Policies.

  An approved permit to construct and design lay–out of a clinical application for a Petition to Operate. 2.No clinical laboratory shall be constructed unless plans have been approved and construction permit issued by the BHFS.shall operate with a valid license issued by BHFS/CHD, based on compliance with the minimum licensing requirements (Annex A).shall be organized and managed to provide effective and efficient laboratory services.shall provide adequate and appropriate safety practices for its personnel and clientele.
• Section 7


  Requirements and Procedures for application of Permit to Construct and License to Operate
• NCR

  January to March
• 1,2,3 & CAR

  February to April
• 4,5 & 6

  March to May
• 7,8 & 9


  April to June
• 10, 11, 12, CARAGA & ARMM

  May to July
• Section 8 Violations


  shall be suspended or revoked by the Secretary of Health upon violation of R.A. 4688 or the Rules and Regulations issued in pursuance thereto.
• Section 9 Investigation of Charges or Complaints


  The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint and verify if the laboratory concerned or any of its personnel is guilty of the charges.