Unit 3.1 Nature of the Clinical Laboratory PDF

PRAYER BEFORE CLASS Holy Spirit, Divine Creator, true source of light and fountain of wisdom! Pour forth your brilliance upon my dense intellect, dissipate the darkness which covers me, that of sin and of ignorance. Grant me a penetrating mind to understand, a retentive memory, method and ease of le...

PRAYER BEFORE CLASS Holy Spirit, Divine Creator, true source of light and fountain of wisdom! Pour forth your brilliance upon my dense intellect, dissipate the darkness which covers me, that of sin and of ignorance. Grant me a penetrating mind to understand, a retentive memory, method and ease of learning, the lucidity to comprehend, and abundant grace in expressing myself. Guide the beginning of my work, direct its progress and bring it to successful completion. This I ask through Jesus Christ, true God, and true man, living and reigning with You and the Father, forever and ever. Amen.  PRINCIPLES OF MEDICAL TECHNOLOGY PRACTICE 1 NATURE OF THE CLINICAL LABORATORY Outline PART I PART II General Overview Sections in the Clinical Classification of Clinical Laboratory Laboratories Laboratory Testing Cycle Quality Assurance in the Clinical Laboratory PART III Philippine Regulations on Clinical Laboratories Learning Outcome 1. Explain the roles, functions, and services offered by the different sections of the clinical laboratory and understand the law governing their operations. GENERAL OVERVIEW What is a Clinical Laboratory? Provide accurate and reliable results Specimens (whole blood, serum, plasma, urine, stool, etc) are processed, analyzed, preserved, and properly disposed Vary in size, function, and the complexity of tests performed What is a Clinical Laboratory? DOH Administrative Order No. 2021-0037 Pre-analytical, analytical, and post-analytical procedures Specimens from the human body are being processed Anatomic pathology, clinical chemistry, clinical microscopy, endocrinology, hematology, immunology and serology, microbiology, toxicology, molecular and nuclear diagnostics CLINICAL LABORATORY MANUAL AUTOMATED Taxing Less laborious Labor intensive Shortened TAT Time consuming More reliable results  CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON OWNERSHIP GOVERNMENT PRIVATE - Operated and maintained - Privately owned by the national government Ex. St Elizabeth Hospital (MediLinx Laboratory), Vitalab Ex. San Lazaro Hospital, UP- PGH CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON INSTITUTIONAL CHARACTER INSTITUTION BASED NON-INSTITUTION BASED - Laboratory located within - Laboratory that operates the premises and independently and is not operates as part of a attached to any DOH DOH licensed health licensed health facility facility CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON FUNCTION CLINICAL PATHOLOGY ANATOMIC PATHOLOGY - chemical and cellular - Provides processing and analyses of blood and examination of surgical other body fluids, specimens identifications and examination of microbes and parasites CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON FUNCTION CLINICAL PATHOLOGY ANATOMIC PATHOLOGY Clinical chemistry Surgical pathology Clinical microscopy Cytopathology Toxicology Therapeutic drug monitoring Immunohistochemical Immunology and serology techniques Hematology and coagulation Autopsies Bacteriology Parasitology Forensic pathology Mycology Virology CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON FUNCTION MOLECULAR PATHOLOGY - Analysis of certain genes, proteins, and other molecules in samples from organs, tissues or body fluids CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON SERVICE CAPABILITY A. Clinical Laboratory for Clinical and Anatomic Pathology B. Clinical Laboratory for Anatomy Pathology ONLY C. Clinical Laboratory for Molecular Pathology ONLY CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON SERVICE CAPABILITY A. Clinical Laboratory for Clinical and Anatomic Pathology 1. Primary Category *minimum of 10 square meters in floor area CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON SERVICE CAPABILITY A. Clinical Laboratory for Clinical and Anatomic Pathology 2. Secondary Category *minimum of 20 square meters in floor area CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON SERVICE CAPABILITY A. Clinical Laboratory for Clinical and Anatomic Pathology 3. Tertiary Category *minimum of 60 square meters in floor area CLASSIFICATION OF CLINICAL LABORATORIES DOH Administrative Order N0. 2021 - 0037 BASED ON SERVICE CAPABILITY A. Clinical Laboratory for Clinical and Anatomic Pathology 4. Limited Services - Dialysis centers - Social hygiene clinics CLASSIFICATION OF CLINICAL LABORATORIES BASED ON SERVICE CAPABILITY 4. National Reference Laboratory - Laboratory in a Government Hospital - Designated by DOH - Provide special diagnostic functions and services for certain diseases CLASSIFICATION OF CLINICAL LABORATORIES BASED ON SERVICE CAPABILITY 4. National Reference Laboratory - Provide laboratory reference/referral services for confirmatory testing - Train laboratory personnel and recognize other training institutions - Maintain the national external quality assessment scheme - Perform technical evaluation of reagents and diagnostic kits  PRINCIPLES OF MEDICAL TECHNOLOGY PRACTICE 1 NATURE OF THE CLINICAL LABORATORY References Benitez, P., Dumaoal, O., Estrella, F., Mortel, F., Nava, M. (2019). Principles of Medical Laboratory Science 1. C and E Publishing, Inc. Department of Health Administrative Order No. 2021-0037. New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines. https://hfsrb.doh.gov.ph/wp-content/uploads/2021/06/ao2021-0037-2.pdf.