Principles of Medical Technology Practice 1

Chapter 8 – Nature of the Clinical According to Institutional Characteristics:

Laboratory 1. Institution-based
Clinical Laboratory  It is a clinical laboratory that operates within
the premises or part of an institution such as
 It is an essential component of health a hospital, school, medical clinic, medical
constitutions. facility for overseas workers and seafarers,
 It provides accurate and reliable information birthing home, psychiatric facility, drug
to medical doctors for the diagnosis, rehabilitation centers, and others.
prognosis, treatment, and management of  Hospital-based clinical laboratories are the
diseases. most common example of institution-based
 It is the place where specimens collected laboratories.
from individuals are processed, analysed, 2. Free-Standing
preserved, and properly disposed.  It is not part of an established institution.
 The most common example is a free-
Medical Technologist/Clinical Laboratory
standing out-patient clinical laboratory.
Scientist
According to Ownerships:
 They plays a very significant role in the
performance of laboratory testing and 1. Government-owned
ensuring the reliability of test results.  Are owned, wholly or partially, by national
or local government units.
CLASSIFICATIONS OF CLINICAL
 Examples are DOH-run government
LABORATORIES:
hospitals like San Lazaro Hospital, Jose R.
According to Function: Reyes Memorial Medical Center and
Bulacan Medical Center.
1. Clinical Pathology
2. Privately-owned
 It is a clinical laboratory that focuses on the
 Are owned, established, and operated by an
areas of clinical chemistry,
individual, corporation, institution,
immunohematology and blood banking,
association or organization.
medical microbiology, immunology and
 Examples are St. Luke’s Medical Center,
serology, hematology, parasitology, clinical
Makati Medical Center, and MCU-FDTMF
microscopy, toxicology, therapeutic drug
Hospital.
monitoring, and endocrinology, among
others. According to Service Capability:
 It is concerned with the diagnosis and
1. Clinical Laboratories under the primary
treatment of diseases performed through
category
laboratory testing of blood and other body
 Are licensed to perform basic, routine
fluids.
laboratory testing, namely, routine analysis,
2. Anatomic Pathology routine stool examination, routine
 It is a clinical laboratory that focuses on the hematology or CBC, WBC, RBC count and
areas of histopathology, Gram staining (if hospital-based)
immunohistopathology, cytology, autopsy,  Equipment requirements are microscopes,
and forensic pathology among others. centrifuge and hematocrit centrifuge.
 It is concerned with the diagnosis of diseases  Space requirement is at least 10 square
through microscopic examination of tissues meters.
and organs.
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2. Clinical Laboratories under 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.
 Minimum equipment requirement are
microscopes, centrifuge, haematocrit
centrifuge, semi-automated chemistry
analyzers, autoclave, incubator, and oven.
 A minimum requirement of 20 square
meters is needed for the floor area.
3. Clinical Laboratories under tertiary
category (Hospital and non-hospital
based)
 Are licensed to perform all the laboratory
tests performed in the secondary category
laboratory plus (1) Immunology and
serology, (2) microbiology, bacteriology,
and mycology, (3) special clinical chemistry,
(4) special hematology, (5)
Immunohematology and blood banking.
 Equipment requirements include those seen
in secondary category laboratories along
with automated chemistry analyzer,
biosafety cabinet class II, serofuge, among
others.
 Tertiary laboratories have a minimum floor
area of at least 60 square meters.
4. National Reference Laboratory
 It is a laboratory in a government hospital
designated by the DOH to provide special
diagnostic functions and services for certain
diseases.
LAWS ON THE OPERATION,
MAINTENANCE, AND REGISTRATION OF
CLINICAL LABORATORIES IN THE
PHILIPPINES
Republic Act No. 4688
 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.
Sections Summarization:
 Shall register and secure a license annually
at the office of the Secretary of Health
 No license shall be granted or renewed by
the Secretary of Health
 Anyone who violates any provisions of this
act shall be punished with imprisonment for
not less than one month but not more than
one year, or by a fine of not less than one
thousand pesos nor more than five thousand
pesos
 The sum of 50,000, or so much thereof as
may be necessary to carry out the provisions
of this act.
Administrative Order No. 59 s. 2001
Rules and Regulation Governing the
Establishment, Operation, and Maintenance of
Clinical Laboratories in the Philippines
Section 1: Title
Section 2: Authority
 These rules and regulations are issued to
implement R.A. 4688:Clinical Laboratory
Law consistent with E.O. 102 Series 1999
Section 3: Purpose
Section 4: Scope
Section 5: Classification of Laboratories
Section 6: Policies
Section 7: Requirements and Procedures for
Application of Permit
Section 8: Violations
Section 9: Investigation of Charges or Complaints
Section 10: Modification and Revocation of License
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Section 11: Repealing Clause
Section 12: Publication and List of Licensed
Clinical Laboratories
Section 13: Effectivity