Clinical Laboratory pt 1 Flashcards
place where specimens such as blood
and other body fluids tissues, feces, hairs,
nail collected from an individual are processed, analyzed, preserved, and properly disposed
Clinical Laboratory
place where biological specimens in particular
such as blood and other body fluids is being
analyzed and processed
Clinical Laboratory
who process, analyze, preserve,
and properly dispose of such particular sample that
is subjected for the testing.
clinical
laboratory scientist or medical laboratory
scientis
an essential
component of health instutitions. Its main task is
to provide accurate and reliable information to
med doctors for the diagnosis, prognosis,
treatment and management of diseases.
Clinical laboratory
Clinical laboratory is the place where specimens such as blood
and other body fluids tissues, feces, hairs,
nail collected from an individual are:
○ Processed
○ Analyzed
○ Preserved
○ Properly disposed
A clinical laboratory can be classified
according to:
○ Function
○ Institutional Characteristics
○ Ownership
○ Service Capability
Classification according to function
Clinical pathology
Anatomic pathology
law that mandates the
licensing and operating of a certain
laboratory
Republic Act No. 4688
In these areas, all laboratory
tests that are performed,
whether it is chemical
analysis, microbiological
analysis or serological
analysis or even
hematological analysis that is
under this classification
Clinical pathology
Concerned with the
diagnosis of diseases
through microscopic
examination of tissues and
organs.
Anatomic pathology
Focuses more on the
analysis or testing of a
certain substance or
microscopic structure of
certain tissues
Anatomic pathology
These area concerned with
diagnosis of diseases
through examination of
microscopic structures such
as cells and other that can be
found in the tissues that can
be visualize
Anatomic pathology
because of this law, clinical
laboratories can be classified according to functions
and in that section
Administrative Order No. 37 s2021
pertains to the analysis of genes
and other proteins that will aid in the
diagnosis of a certain disease
Molecular pathology
Detecting the presence of certain
genes like DNA or Rna and other
proteins that made up the certain cell
or tissue in the human body
Molecular pathology
Classification under institutional characteristics
Institution-based
Free-standing
Operates within the premises or part
of an institution such as hospital,
school, medical clinic, medical
facility for overseas workers and
seafarers, birthing home,
psychiatric facility, drug
rehabilitation center and other.
Institution-based
Most common edxample of institution-based laboratories
Hospital-based
Not part of an established institution.
Free Standing
Common example of free-standing
free-standing out-patient clinical
laboratory.
services that can be provided
are only limited to the laboratory
services,
Free-standing
Classification according to ownership
Government-owned
Private-owned
Two types of government-owned laboratories
DOH-run
Local government-run
● Also called as public
● Owned, wholly or partially, by
national or local government units
Government-owned
Type of government-owned; San Lazaro Hospital, Jose R.Reyes Memorial Medical Cwenter, UPGH
DOH-run
Type of government-owned; Ospital ng Myanila Medical Center
Local government-run
Clinical lab according to service capability
Primary
Secondary
Tertiary
Basic routine laboratory testing; space req is at least 10 sq m
Primary
Equipments are, but not limited to, microscopes. centrifuge, hematocrit centrifuge
Primary
License to perform laboratory
tests being done by the primary
category laboratories along with
○ Routine chemistry tests like
blood glucose concentration
○ Blood urea nitrogen, blood
uric acid, blood creatinine,
cholesterol determination,
qualitative platelet count,
○ If hospital based, Gram stain,
KOH (potassium hydroxide)
mount, and crossmatching
Secondary
Space requirement for secondary
20 sq cm
Minimum req equipment includes
○ Microscope
○ Centrifuge
○ Hematocrit centrifuge
○ Semi-automated chemistry
analyzers
○ Autoclave
○ Incubator
○ Oven
Secondary category
Licensed to perform all the
laboratory tests performed in the
secondary category laboratory plus other
Tertiary
▪ Ns1-Ag for dengue
▪ Rapid plasma reagin
▪ Treponema pallidum
particle agglutination
tests
Immunology and Serology
▪ Differential staining
techniques
▪ Culture and ID
▪ Antimicrobial
susceptibility testing
Microbiology, bacteriology
and mycolog
▪ Clinical enzymology
▪ Therapeutic drug
monitoring
▪ Markers for certain
disease
Special Chemistry
▪ Bone marrow studies
▪ Special staining for
abnormal cells, red
cell morphology
○ Immunohematology an
Special Hematology
▪ Blood donation
program
3
▪ Antibody screening
and ID
▪ Preparation of blood
components
Most critical in the clinical laboratory
Immunohematology / blood banking
▪ Those seen in
secondary category
laboratories along
with :
▪ Automated chemistry
analyzer
▪ Biosafety cabinet
class II
▪ Serofuge
Equipment
Minimum space floor req for tertiary
60 sq cm
Laboratory in a government hospital
designated by the DOH to provide special
diagnostic functions and services for certain
diseases.
National Reference Laboratory
Includes
○ Referral services
○ Provision of confirmatory testing
○ Assistance for research activities
○ Implementation of External Quality
Assurance Programs (EQAP) of the
government
NRL
○ Resolution of conflicts regarding test
results of different laboratories
○ Training of medical technologists on
certain specialized procedures that
require standardization
○ Examples are Lung Center of the
Philippines, National Kidnet Transplant Institute, etc
National Reference Laboratoties
An act regulating the operationa nd mantenance 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
Republic Act No. 4688
Approval date of RA 4688
June 18, 1996
Where do clinical laboratories register and secure a license
Secretary of Health
How can a person be professionally incharge of the laboratory
He must be a LICENSED PHYSICIAN qualified in the laboratory medicine and authorized by the Secretary of Health
charged with the responsibility of strictly enforcing the provisions of RA 4688
Secretary of Health
Violation of RA 4688 may issue imprisonment of ____ and fine of _____
not less than one month bur not more than one year, not less than one thousand pesos nor more than five pesos (or both at the discretion of the court)
First amendment that was made for RA
4688
Administrative Order No. 59 s. 2001
Rules and Regulation Governing the
Establishment, Operation, and Maintenance
of Clinical Laboratories in the Philippines
Administrative Order No. 59 s. 2001
Department of Health (DOH) through
the __________ in the Health
Regulation Cluster, shall exercise
the regulatory functions under these
rules and regulations under AO 59 s 2001
Bureau of Health Facilities and
Services (BHFS)
Regulations of AO 59 s 2001 shall apply to ________
all entities performing the activities (aside govt labs provided that they are an extension)
An approved permit to construct
and design layout of a clinical
laboratory shall be secured from the
________
BHFS
A clinical laboratory shall operate
with a valid license issued by
BHFS/CHD
Application for Permit to Construct requirements include:
○ Letter of Application to the
Director of BHFS
○ Four (4) sets of Site
Development Plans and
Floor Plans approved by an
architect and/or engineer
○ DTI/SEC Registration (for
private clinical laboratory)