Clinical Laboratory

BIO-101: PRINCIPLES IN MEDICAL LABORATORY SCIENCE 1

LECTURE 1:
1st SEMESTER | S.Y. 2023
-2024 TRANSCRIBED BY: ZEE S. SABANAL
LECTURER:Liza Nawal
Ppt info:
 A place, establishment or institution organized
and operated primarily for the performance of
bacteriological, biochemical, microscopical,
serological or parasitological tests
 Practical application of one or more of the
fundamental sciences to material originating
from the human body, by the use of specialized
apparatus, equipment and methods, for the
purpose of obtaining scientific data which may be
used as an aid to ascertain the state of health.
 A clinical laboratory shall be of such
construction so that no hazards to the life and
safety of patients, personnel and public exist.
 It shall be capable of withstanding weight and
elements to which they may be subjected.
 It shall be provided with sufficient
illumination and adequate ventilation to
enable personnel in the performance of work
and to ensure comfort of patients, personnel
and public.
 Floors, walls, ceilings, fixtures and furniture
shall be of sturdy materials that shall allow
durability, ease of cleaning, fire and acid
resistance.
 There shall be measures for detecting fire
such as fire alarms in walls, peepholes in
doors or smoke detectors in ceilings. There
shall be devices for quenching fire such as fire
extinguishers or fire hoses that are easily
visible and accessible in strategic areas.
 Proper maintenance shall be provided to
prevent untimely breakdown of building and
equipment.
 Liquid waste shall be discharged into an
approved public sewerage system, and solid
waste shall be collected, treated and disposed
of in accordance with applicable codes, laws or
ordinances.
Said info:
 Essential component of health institution
 Main task of collecting different types of samples
in order to test what cause illness
 Main task to provide accurate and reliable
information for medical doctors or diagnosis,
prognosis, treatment and management of disease
 W a place where specimen are collected from
individuals in a process to analyze, preserve, and
properly dispose.
TYPES OF CLINICAL LABORATORY ACCORDING TO:
 FUNCTIONS
 OWNERSHIP
 SERVICE CAPABILITY
 INSTITUTION CHARACTER
FUNCTIONS
1. Clinical Pathology
 A clinical laboratory based on function which
includes hematology, clinical chemistry,
microbiology, parasitology, mycology,
immunology and serology, immunohematology,
blood banking, laboratory endocrinology,
toxicology and therapeutic drug monitoring and
etc.
2. Anatomical Pathology
 A clinical laboratory based on function which
include surgical pathology,
immunohistopathology, cytology, autopsy, and
forensic pathology.
 Clinical pathology involves testing of body fluids
such as urine, blood and saliva
 Examine samples from organs and other tissues
most commonly required through surgery.
OWNERSHIP
Government
 Operated and maintained, partially or wholly, by
the national government, with local government
unit, any other political unit.
 Ex: Clinical and Anatomical Labo f DOH: San
Lazaro Hospital, Jose Reyes, UP Philippine
general hospital.
Private
 Owned, established and operated by any
individuals, corporation, association,
organization.
 Ex: St luke medical center, makati medial center,
Davao Doctors Hospital.
SERVICE CAPABILITY
 Primary, Secondary, Tertiary Laboratory
PRIMARY LABORATORY
 Traditional laboratory
 Is the initial step in establishing a clinical
laboratory if the patients are from a small
community, a barangay or within vicinity
 Laboratory examinations: Routine hematology,
urinalysis, fecalysis, gram staining, blood typing.
Said info:
 Counting of hemoglobin, hematocrit, wbc and
RBC count, WBC differential count, qualitative
platelet.
 Floor area: 10 square meters with toilet, Clinical
work with sink, pathologist area.
 Equipment: clinical centrifuge, differential blood
counter, hemocytometer, hemoglobinometer,
microhematocrit centrifuge, microscope with oil
immersion objective, & the most commonly used
centrifuge for urine analysis and blood
specimens.
 SECONDARY LABORATORY
 Conventional Laboratory with Partially / Semi-
Automated Instruments.
 Caters to larger groups of community residents,
and can be a hospital- based or school-based
laboratory.
 Laboratory examinations: Routine hematology
tests, routine chemistry tests (glucose, uric acid,
cholesterol, urea nitrogen, creatinine) urinalysis,
fecalysis, gram staining, blood typing, serological
tests, bacteriological analysis, crossmatching
 Floor area: 20 square-meter with toilet, clinical
work area with sink & pathologist area.
 Equipment (those in primary): +photometer,
refrigerator, timer and water bag.
 TERTIARY LABORATORY
 Sophisticated Laboratory with Fully-automated
machines
 Complete laboratory including all those in
Secondary Laboratory and comprising six to eight
sections
o Clinical Chemistry, Hematology, Clinical
Microscopy, Immunohematology and
Blood bank, Immunology and Serology,
Microbiology, Histopathology.
o Immunology & serology test: Ns1
antigen for dengue, rapid plasma reagin
Intrepenemopalipdum particle
agglutination test, Persepolis infection.
o Microbiology test: Differential staining
techniques, culture and identification of
bacteria and fungi, AST testing or
antimicrobial susceptibility testing.
o Clinical Chemistry test: Clinical
enzymology, therapeutic drug monitoring
and biomarkers for certain disease.
o Hematology test: bone marrow studies
uses spinal fluid, red cell morphology.
o Immunology & blood banking: blood
donation program, anti-body screening
and ID, preparation of blood components.
INSTITUTIONAL CHARACTER
Institution Based
 A laboratory that operates within the premises
and as part of an institution, such as but not
limited to hospital, medical clinic, school, medical
facility for OFW.
 Ex: Department of pathology of national kidney
and transplant institute.
Free Standing
 A laboratory that does not form part of any other
institution.
 No affinity with any other Institution
 Ex: High Precision Diagnostic Laboratory.
CLINICAL LABORATORY LAW
RA 4688
 "Clinical Laboratory Law of 1966"
 on June 18, 1966
A.O No. 59 S. 2001
 Implementing guidelines of RA 4688 which is
titled: Rules and Regulations Governing the
 Establishment, Operation, and Maintenance of
Clinical Laboratory in the Philippines Pre-Analytical Phase
 Phase of quality
AO No. 27 s. 2007
Analytical Phase
 Revised Rules and Regulations Governing the  Phase where test analysis, quality control,
Licensure and Regulation of Clinical Laboratories calibration, and preventive maintenance.
in the Philippines. Revised IRR Governing the Post
Establishment, Operation, and Maintenance of  Analytical Phase
Clin Lab.
Section 1
 all labs should be licensed and regulated by the
DOH (except government labs doing minimum
lab exams)
Section 2
 licensed physicians should be in-charge of the
labs
Section 3
 DOH-BRL is the one in-charge with the
implementation of this act and to issue rules and
regulations
 Only the DOH can thoroughly inspect and
examine the laboratory if they are capable of
doing services
Section 4
 punishment for violators (1 month-1 year
imprisonment, 1000- 5000 pesos fine)
Section 5
 Separability Clause.
Section 6
 Php 50,000 from the National Treasury are
appropriated to carry out this act
Section 7
 Repealing Clause.
Section 8
 Effectivity (May 19, 1966)

QUALITY CONTROL, ACCURACY & PRECISION

Quality Control
 Insurance of a method to remain valid over time.
Accuracy
 Nearness of the result to the true value.
Precision
 Nearness of the result to the one another.

CYCLE OF CLINICAL LABORATORY TESTING