New Era University

CENTER FOR MEDICAL & ALLIED HEALTH SCIENCES

COLLEGE OF MEDICAL TECHNOLOGY
MTML22-18: MEDICAL TECHNOLOGY LAWS & BIOETHICS
ASSIGNMENT IN R.A. 4688 - CLINICAL LABORATORY LAWS
Herna, Erin Jonah F.
Name:_______________________________________________________________Score:______________
2CMT-4 TH 4:30PM – 7:30PM 02/29/2024
Section:_____________________________Schedule:________________________Date:_______________
DIRECTION: Answer the questions direct to the point.
1. What are the requirements in establishing the Clinical Laboratory?
 It is required to register and secure a license in order to establish a clinical laboratory. For
the clinical laboratory to be licensed, it is required that the one who will be professionally
in-charge should be a licensed physician duly qualified in laboratory medicine and
authorized by the Secretary of Health.
2. Name seven (7) laboratories and classify them as clinical or anatomic; institutional – based or
free-standing; and primary, secondary, or tertiary. Justify the classification.
a. Makati Medical Center Laboratory
 Type: Clinical Laboratory
 Classification: Institutional-based (part of Makati Medical Center)
 Level of Care: Tertiary
b. Philippine General Hospital (PGH) Pathology Laboratory
 Type: Anatomic Laboratory
 Classification: Institutional-based (part of PGH)
 Level of Care: Tertiary
c. St. Luke's Medical Center - Quezon City Laboratory
 Type: Clinical Laboratory
 Classification: Institutional-based (part of St. Luke's Medical Center)
 Level of Care: Tertiary
d. Manila Doctors Hospital Laboratory
 Type: Clinical Laboratory
 Classification: Institutional-based (part of Manila Doctors Hospital)
 Level of Care: Tertiary
e. The Medical City Laboratory
 Type: Clinical Laboratory
 Classification: Institutional-based (part of The Medical City)
 Level of Care: Tertiary
f. Healthway Medical Clinics Laboratory
 Type: Clinical Laboratory
 Classification: Free-standing
 Level of Care: Primary to Secondary
g. Hi-Precision Diagnostics Laboratory
 Type: Clinical Laboratory
  Classification: Free-standing
 Level of Care: Primary to Secondary
3. What is the main role of HFSRB (formerly BRL/BHFS) in establishing laboratory?
 The Health Facilities and Services Regulatory Bureau (HFSRB), formerly known as the
Bureau of Research and Laboratories (BRL) or Bureau of Health Facilities and Services
(BHFS), plays a crucial role in establishing laboratories in the Philippines. Its main role
involves regulation, accreditation, and oversight of healthcare facilities, including
laboratories, to ensure they meet established standards for quality, safety, and
effectiveness.
4. Identify the various section of a clinical laboratory present among primary, secondary and
tertiary laboratory.
 Primary Category – provides the following minimum service capabilities:
1. Routine Hematology [Complete Blood Count – includes Hemoglobin Mass
Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte Number
Concentration (White Blood Cell or WBC count) and Leucocyte Number Fraction
(Differential count)
2. Qualitative Platelet Determination
3. Routine Urinalysis
4. Routine Fecalysis
5. Blood typing – for hospital based
 Secondary Category – provides the minimum service capabilities of a primary category
laboratory plus the following:
1. Routine Clinical Chemistry – includes Blood Glucose Substance Concentration, Blood
Urea Nitrogen concentration, Blood Uric Acid Substance Concentration, Blood
Creatinine Concentration, Blood Total Cholesterol Concentration
2. Quantitative Platelet Determination
3. Cross matching – for hospital based
4. Gram Staining – for hospital based
5. KOH – for hospital based
 Tertiary Category – provides the minimum service capabilities of a secondary category
laboratory plus the following:
1. Special Chemistry
2. Special Hematology, including coagulation procedures
3. Immunology
4. Microbiology – culture and sensitivity
5. What are the functions of the National Reference Laboratory? Cite at least four (4) examples.
 The National Reference Laboratory (NRL) plays a crucial role in public health systems by
providing specialized diagnostic services, technical expertise, research, and quality
assurance functions.
1. Disease Surveillance and Monitoring
2. Diagnostic Testing and Confirmation
3. Research and Development
4. Capacity Building and Training
6. What are the grounds of a clinical laboratory that could lead into revocation and suspension of
Clinical Laboratory?
 The revocation or suspension of a clinical laboratory's license in the Philippines can occur
for various reasons related to non-compliance with regulatory standards, ethical violations,
or failure to maintain quality assurance practices.
7. What is the purpose of Administrative Order 2007-0027?
 The purpose of the Revised Rules and Regulations is to ensure accurate and high-quality
laboratory examinations for the prevention, diagnosis, and treatment of diseases.
 The law aims to safeguard public health and safety by recognizing the importance of
laboratory work-ups in aiding the diagnosis and management of patients.
 The law acknowledges the need to update the minimum standards and technical
requirements for clinical laboratories due to advances in technology.