THE CLINICAL LABORATORY
of strictly enforcing the provisions of this
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
 Approved: June 18, 1966
 President Ferdinand Edralin Marcos
SECTION 1
• Any person, firm or corporation,
operating and maintaining a clinical
laboratory in which body fluids, tissues,
secretions, excretions and radioactivity
from beings or animals are analyzed for
the determination of the presence of
pathologic organisms, processes and/or
conditions in the persons or animals
from which they were obtained, shall
register and secure a license annually at
the office of the Secretary of Health:
provided, that government hospital
laboratories doing routine or minimum
laboratory examinations shall be exempt
from the provisions of this section if their
services are extensions of government
regional or central laboratories.
SECTION 2
• It shall be unlawful for any person to be
professionally in-charge of a registered
clinical laboratory unless he is a
licensed physician duly qualified in
laboratory medicine and authorized by
the Secretary of Health, such
authorization to be renewed annually.
No license shall be granted or renewed
by the Secretary of Health for the
operation and maintenance of a clinical
laboratory unless such laboratory is
under the administration, direction and
supervision of an authorized physician,
as provided for in the preceding
paragraph.
SECTION 3
• The Secretary of Health, through the
Bureau of Research and Laboratories
shall be charged with the responsibility
Act and shall be authorized to issue
such rules and regulations as may be
necessary to carry out its provisions.
SECTION 4
• Any person, firm or corporation who
violates any provisions of this Act or the
rules and regulations issued thereunder
by the Secretary of Health 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, or both such fine and
imprisonment, at the discretion of the
court.
CLINICAL LABORATORY
Implementing Rules and Regulation (IRR)
• A facility subdivided into different
sections where common diagnostic
procedures are done by specialized
health professionals
• Regulated by the Bureau of Health
Facilities and Services under DOH
which prevents the operation of
substandard laboratories
BASED ON OWNERSHIP
• Government
• Operated and maintained by a
government unit
• Private
• Owned, operated, and
established by any individual,
corporation, association, or
organization
BASED ON FUNCTION
• Clinical Pathology
• Clinical Chemistry, Hematology,
Immunohematology, etc.
• Anatomic Pathology
• Surgical Pathology,
Immunohistopathology, Cytology,
Autopsy, Forensic Pathology,
Molecular Pathology
BASED ON INSTITUTIONAL CHARACTER
• Institution-based
• A laboratory that operates within
the premises and is a part of an
institution
• Freestanding
• A laboratory that does not form
part of any other institution
BASED ON SERVICE CAPABILITY
o PRIMARY: 10 sq.m. (minimum space
required)
• Routine Hematology
• Routine Urinalysis
• Routine Fecalysis
• Qualitative Platelet
• Blood typing (hospital-based)
o SECONDARY: 20 sq.m. (minimum
space required)
• All tests in primary lab
• Routine Chemistry
• Quantitative Platelet
• Cross-matching; Gram staining;
KOH (hospital-based)
o TERTIARY (60 sq.m.)
• All tests in secondary lab
• Special Chemistry
• Special Hematology
• Immunology-Serology
• Microbiology
o LIMITED SERVICE CAPABILITY
• Dialysis centers
• Social hygiene clinics
SPECIAL CLINICAL LABORATORIES
 Provides highly specialized lab services
not provided by a general clinical lab
NATIONAL REFERENCE LABORATORY
• A laboratory in a government hospital
which is designated to provide special
functions and services such as:
• Confirmatory testing
• Surveillance
• Resolution of conflicts
• Training and research
• Evaluation of kits and reagents
• External quality assessment
program
NRLs in the Philippines
• National Kidney and Transplant Institute:
Hematology, Immunohematology,
Automated Urinalysis, Immunopathology
• East Avenue Medical Center: Toxicology
• Lung Center of the Philippines: Clinical
Chemistry
SPECIMEN COLLECTION AND HANDLING
• The accuracy of laboratory testing
begins with the quality of specimen
received by the laboratory
• This quality depends on how the
specimen was collected, transported
and processed.
• A laboratory assay will be no better than
the specimen on which it is performed.
• A specimen that is improperly collected,
stored or mishandled should not be
tested and therefore the results
becomes invalid
REMINDERS in SC and H
• The proper handling of specimens
(blood, Bf, Tissue etc.) is critical to the
accuracy of laboratory test results
• Specimens should be transported to the
laboratory immediately
• Label specimens correctly
• Specimens must be collected in sealed
(with lid /cap), leaked proof, disposable
plastic containers.
• Maintain specimens at correct
temperature at all times and collect only
the desired quantity
• Never expose specimen to severe
environmental conditions
• PPE must always be worn at all times
when handling biologic specimens.
Factors that contribute to Lab errors
• The most common errors are related to
specimen collection and handling (Pre-
analytical stage)
• Pre-analytical, Analytical, Post-analytical
errors(mistakes)
 • Errors/ Mistakes can be prevented when • You are expected to deliver unexcelled
MT are well trained and are aware of the customer satisfaction
sources of error. • You have to understand and know the
• When in doubt about the quality of patient’s expectation
collected specimen always recommend • Manage unrealistic expectations through
for repeat collection and refer and patient education
document the incident to your superiors. • Be diplomatic with patient complaints
• If the patient is unhappy
Patient care partnership • Should listen with interest
• Patient- Term originating from the Latin • Express genuine concern by
patior meaning to suffer; one who making attempts to resolve the
suffers or is ill and requires treatment. issue of concern
• A person under a physician's • If at fault an apology would be
care for a particular disease or appropriate
condition. • Gentle and compassionate at all
• In some institutional settings it is times
not used because it is thought to
denote a dependent relationship
on the part of the person
undergoing treatment. The words
client, resident, and at times
guest can also be used to refer to
a person receiving treatment.
• Patient’s Bill of Rights
It is important that Healthcare workers should
always consider the rights of the patient at all
times.
 Right to appropriate medical care
and humane treatment
 Right to informed consent
 Right to privacy and
confidentiality
 Right to information
 Right to choose healthcare
provider and facility
 Right to self determination
 Right to religious beliefs
 Right to medical records
 Right to leave
 Right to express grievances
 Right to correspondence and
received visitors
 Right to participate in medical
research
 Right to b informed of his rights
and responsibilities as a patient.

• Types of patients
Pediatrics (Infants &children), Adolescent
(teens), Adult, Geriatrics (old)

MT role in PCR