THE CLINICAL LABORATORY
and shall be authorized to issue such
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 of
strictly enforcing the provisions of this Act
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
MT are well trained and are aware of the
sources of error.
• When in doubt about the quality of
collected specimen always recommend
 for repeat collection and refer and • Be diplomatic with patient complaints
document the incident to your superiors. • If the patient is unhappy
• Should listen with interest
Patient care partnership • Express genuine concern by
• Patient- Term originating from the Latin making attempts to resolve the
patior meaning to suffer; one who suffers issue of concern
or is ill and requires treatment. • If at fault an apology would be
• A person under a physician's care appropriate
for a particular disease or • Gentle and compassionate at all
condition. times
• In some institutional settings it is
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
• You are expected to deliver unexcelled
customer satisfaction
• You have to understand and know the
patient’s expectation
• Manage unrealistic expectations through
patient education