Professional Documents
Culture Documents
TECHNOLOGY/ CLINICAL LAB SCIENCE PROFESSION excretions of the human body and body fluids by
various laboratory procedures and techniques.
Definition and Nature of Medical Technology
• Blood banking procedures and techniques
Anne Fagelson – Branch of Medicine concerned with • Clinical research involving human beings
the performance of laboratory requiring the use of and/or application of
determinations and analysis used in the medtech knowledge and procedure.
diagnosis and treatment of diseases and • Preparations and standardization of reagents,
maintenance of health. standards, stains and others (exclusively for the
use of their lab).
Ruth Heinemann – The application of principles of • Lab quality control
natural, physical and biological sciences • Collection and preservation of specimens
to the performance of lab procedures
which aid in the diagnosis and treatment Medical Technology Code of Ethics (Revised by Rodolfo
of diseases. Rabor)
Be Honest in Practice
Demonstrate Professionalism
Uphold Confidentiality
Conduct Research
Types of Abortion
History of Medical Technology in a Global Context • Greatly contributed to the development of the
microscope
300BC – 180AD
• Simple-celled form: portists
Hippocrates (Father of Medicine) • Animalcules (Protozoa)
Medieval Times
900AD
11th Century
15 - 16th Century
17th Century
Disinfection
Levels of Disinfection
LESSON 8: NATURE OF THE CLINICAL LABORATORY Operates with the premises or part of an institution
(Hospitals, schools, med clinic, medical facilities)
Clinical Laboratory
• The place where specimens collected from 2. Free-standing
4. New government institutional policies Routine Primary lab tests All test of sec
urinalysis BGC category
Classifications of Clinical Laboratories
Routine stool BUN Immunology and
Concerned with the diagnosis of diseases through Qualitative KOH mount Immunohematology
platelet count Crossmatching and blood banking
microscopic examination of tissues and organs
Blood typing
According to Institutional Characteristics
Gram staining 6. Inspection (every 2 yrs. or as necessary)
7. Monitoring
National Reference Laboratory 8. Issuance of License (License is non-
A laboratory in a gov’t hospital designated by the DOH transferable)
9. Terms and Conditions of License
to provide special diagnostic functions and service for
Section 8: Violation
certain diseases
• Operation of a clinical lab w/o a certified
Laws on the Operation, Maintenance, and Registration pathologist or w/o a RMT
• Changes of ownership, location, head of laboratory
of Clinical Laboratories in the Philippines (I SUGGEST
or personnel w/o informing the BHFS and/ or the
YOU READ THE BOOK ABOUT THIS SECTION) CHD
• Refusal of BHFS inspection of clinical lab during
Republic Act No. 4688 (Clinical Laboratory Law June 18 reasonable hours by authorized person(s)
1966) • Gross negligence
• Any act or omission detrimental to the public
Administrative Order No. 59 s. 2001 (New ver. Revised • Provincial, City and Municipal Health Officers are
AO 2007-0027) I WOULD ADVISE READING THE BOOK authorized to report to the CHD and BHFS
ABOUT THIS PART Section 9: Investigation of Charges or Complaints
Violating RA 4688 or any of suspend, cancel, or revoke
Section 1: Title these rules and regulation for a determined period of
time the license
Section 2: Authority Any person w/o proper Imprisonment 1mo ≤ X ≤ a
BHFS – Exercise the regulatory functions under these license who still operates a year OR a fine 1,000≤ X ≤
rules and regulation clinical laboratory 5000 OR Both
Any clinical lab operating Closed upon order issued
Section 3: Purpose w/o a valid licensed or a by the BHFS/CHD (Hindi
revoked/cancelled early close ha)
To protect the health of the people and in compliance
with quality standards
Section 10: Modification and Revocation of License
Section 4: Scope
Section 11: Repealing Clause
Section 5: Classification of Laboratories Rules and regulation shall supersede all other previous
official issuances
Section 6: Policies
Section 12: Publication and List of Licensed Clinical
Section 7: Requirements and Procedures for Laboratories
A list of licensed clinical laboratories is published
Application of Permit to Construct and License to
annually (every 1 year)
Operate
Section 13: Effectivity
1. Application for permit to Construct Rules and regulations take affect 15 days after its
publication
2. Application for New License
3. Application for renewal of license ANNEX A
• Certificate from EQAS is required for renewal that I. STAFFING
states “satisfactory” • Managed by a licensed physician certified by the
• 90 days before the expiry date of the license PBP or a pathologist
• Physician who undergo 3 months of training
4. Permit and License Fee
certified by BHFS
5. Penalties
• Qualified and adequately train personnel
1000 pesos penalty for late renewal + 100 for
each month of delay
• Sufficient number of RMT proportional to the • Deals with the enumeration of cells in the blood and
workload and shall be available at all times other body fluids
• At least 1 MT per shift
• Coagulation studies focus on blood testing for the
• Staff development and education program
determination of various coagulation factors
II.
PHYSICAL FACILITIES
• Bone marrow examination
• Well-ventilated, adequately lighted, clean and safe
• Sufficient working space Clinical Microscopy
• Adequate water supply
1st area: routine and other special examinations of urine
• 10 sqm • 20sqm • 60sqm
Primary Secondary or urinalysis
Tertiary
2nd area: the examination of stool or routine fecalysis
III. EQUIPMENT/INSTRUMENTS
Blood Bank/Immunohematology
IV. GLASSWARES/REAGENTS/SUPPLIES • Main Activities: Blood Typing and Compatibility
V. WASTE MANAGEMENT testing
Guidelines of the DOH and the local government for
• Screening for all antibodies and identification of
adequate and efficient disposal
antibodies and blood components used for
VI. QUALITY CONTROL PROGRAM
Internal and External Quality Control Program transfusion
• Most critical section in the clinical laboratory
VII. REPORTING (name and signature of RMT and
Pathologist, except emergency cases) Immunology and Serology
VIII. RECORDING • Analysis of serum antibodies in certain infectious
All laboratory records shall be kept on file for atleast agents
1yr except anatomic and forensic pathology records are
kept forever (may forever) Anatomic Pathology
IX. LABORATORY FEES Histopathology/Cytology
• Tissue processing, cutting into sections, staining,
Sections of the Clinical Laboratory and preparation for microscopic examination by a
• For the testing of blood and other body fluids to Specialized Sections of the Laboratory
quantify essential soluble chemicals including Immunohistochemistry
waste products useful for diagnosis of certain • Combines anatomical, clinical, and biochemical
Liner: Yellow plastic (can withstand autoclaving), with Toxic Corrosive Flammable Reactive
label and tag (source, weight, collection data)