with the examination of tissues and cells
to diagnose diseases and conditions.
1. What is the main purpose of a clinical laboratory?
A. To collect specimens from individuals
B. To analyze and process specimens from individuals
C. To dispose of specimens from individuals
D. To preserve specimens from individuals
E. To provide medical treatment to individuals
Answer: B. To analyze and process specimens from individuals. The clinical laboratory is responsible
for processing, analyzing, preserving, and properly disposing of specimens collected from individuals.
2. How are clinical laboratories classified according to function?
A. By ownership
B. By service capability
C. By institutional characteristics
D. By function
E. By location
Answer: D. By function. Clinical laboratories are classified according to function into two categories:
clinical pathology and anatomic pathology.
3. Which of the following is not a section of clinical pathology?
A. Clinical Chemistry
B. Immunohematology
C. Medical Microbiology
D. Immunology and Serology
E. Histopathology
Answer: E. Histopathology. Histopathology is a section of anatomic pathology, not clinical pathology.
4. What is the focus of anatomic pathology?
A. Analyzing body fluids
B. Diagnosing infectious diseases
C. Examining tissues and cells to diagnose diseases and conditions
D. Monitoring therapeutic drug levels
E. Providing medical treatment to individuals
Answer: C. Examining tissues and cells to diagnose diseases and conditions. Anatomic pathology is
concerned with the examination of tissues and cells to diagnose diseases and conditions.
5. How are clinical laboratories classified according to institutional characteristics?
A. By ownership
B. By service capability
C. By function
D. By location
E. By accreditation status
Answer: A. By ownership. Clinical laboratories can be classified according to institutional characteristics
based on ownership, such as government-owned, privately-owned, or hospital-based.
1. What is the focus of Anatomic Pathology?
A. Histopathology
B. Immunohistopathology
C. Cytology
D. Autopsy
E. Forensic pathology
Answer: A. Histopathology
Explanation: Anatomic Pathology is concerned with the diagnosis of diseases through microscopic
examination of tissues and organs. Its focus is on histopathology, which involves the examination of
tissues for abnormalities.
2. What does Molecular Pathology deal with?
A. Certain genes
B. Proteins
C. Other molecules in samples from organs, tissues or bodily fluids
D. All of the above
E. None of the above
Answer: D. All of the above
Explanation: Molecular Pathology deals with the analysis of certain genes, proteins, and other
molecules in samples from organs, tissues, or bodily fluids in order to diagnose disease and guide
prevention and treatment. It uses the principles, techniques, and tools of molecular biology as they are
applied to diagnostic medicine in the laboratory.
3. What is the most common type of Institution-based laboratory?
A. Hospital-based
B. School-based
C. Medical clinic-based
D. Birthing home-based
E. Psychiatric facility-based
Answer: A. Hospital-based
Explanation: Institution-based laboratories operate within the premises or part of an institution such as
a hospital, school, medical clinic, medical facility for overseas workers and seafarers, birthing home,
psychiatric facility, drug rehabilitation center, and others. The most common type is hospital-based.
4. What is a free-standing laboratory?
A. A laboratory that is not part of an established institution
B. A laboratory that is part of a hospital
C. A laboratory that is part of a school
D. A laboratory that is part of a medical clinic
E. A laboratory that is part of a psychiatric facility
Answer: A. A laboratory that is not part of an established institution
Explanation: Free-standing laboratories are not part of an established institution. The most common
example is a free-standing out-patient clinical laboratory. These laboratories are not affiliated with a
hospital or other healthcare facility and operate independently.
5. What is the ownership of a government-owned laboratory?
A. Owned, wholly or partially, by national or local government units
B. Owned by private individuals or corporations
C. Owned by non-profit organizations
D. Owned by educational institutions
E. Owned by religious organizations
Answer: A. Owned, wholly or partially, by national or local government units
Explanation: Government-owned laboratories are owned, wholly or partially, by national or local
government units. These laboratories are usually established to provide healthcare services to the
public and are funded by the government. Private-owned laboratories, on the other hand, are owned by
private individuals or corporations.
1. Which of the following best describes government-owned businesses?
a) Owned by individuals or corporations
b) Owned by national or local government units
c) Owned by a group of people
d) Owned by a non-profit organization
e) Owned by a foreign government
Answer: b) Owned by national or local government units. Government-owned businesses are wholly or
partially owned by the government.
2. What is the primary category of laboratory testing?
a) Advanced laboratory testing
b) Routine laboratory testing
c) Specialized laboratory testing
d) Emergency laboratory testing
e) None of the above
Answer: b) Routine laboratory testing. The primary category includes basic, routine laboratory testing
such as routine urinalysis, routine stool examination, routine hematology or complete blood count,
hemoglobin, hematocrit, WBC and RBC count, WBC differential count, and qualitative platelet count.
3. What is the space requirement for the primary category laboratory?
a) 5 sq.m.
b) 10 sq.m.
c) 15 sq.m.
d) 20 sq.m.
e) 25 sq.m.
Answer: b) 10 sq.m. The primary category laboratory requires a space of 10 sq.m.
4. Which of the following is included in the secondary category laboratory testing?
a) Basic laboratory testing
b) Routine laboratory testing
c) Specialized laboratory testing
d) Emergency laboratory testing
e) None of the above
Answer: b) Routine laboratory testing. The secondary category laboratory includes routine chemistry
tests like blood glucose concentration, blood urea nitrogen, blood uric acid, blood creatinine,
cholesterol determination, and qualitative platelet count.
5. What is the space requirement for the secondary category laboratory?
a) 5 sq.m.
b) 10 sq.m.
c) 15 sq.m.
d) 20 sq.m.
e) 25 sq.m.
Answer: d) 20 sq.m. The secondary category laboratory requires a space of 20 sq.m.
1. What is n in laboratory testing?
a) The number of samples tested in a day
b) The number of laboratory technicians working in the lab
c) The number of tests performed on a sample
d) The number of reagents used in a test
e) None of the above
Answer: c) The number of tests performed on a sample
Explanation: n refers to the number of tests performed on a sample in laboratory testing.
2. What is a KOH mount used for in laboratory testing?
a) To detect fungal infections
b) To detect bacterial infections
c) To detect viral infections
d) To detect parasitic infections
e) None of the above
Answer: a) To detect fungal infections
Explanation: A KOH mount is a laboratory test used to detect fungal infections by examining a sample
under a microscope after treatment with potassium hydroxide.
3. What is crossmatching in blood banking?
a) A test to determine blood type
b) A test to determine the presence of antibodies in the blood
c) A test to determine the compatibility of donor and recipient blood
d) A test to determine the presence of infectious agents in the blood
e) None of the above
Answer: c) A test to determine the compatibility of donor and recipient blood
Explanation: Crossmatching is a laboratory test used in blood banking to determine the compatibility of
donor and recipient blood before a transfusion.
4. What is the minimum floor area requirement for a laboratory in the tertiary category?
a) 10 sq.m.
b) 20 sq.m.
c) 30 sq.m.
d) 40 sq.m.
e) 50 sq.m.
Answer: b) 20 sq.m.
Explanation: The minimum floor area requirement for a laboratory in the tertiary category is 20 sq.m.
5. What equipment is required in a laboratory in the tertiary category?
a) Microscopes, centrifuge, and autoclave
b) Semi-automated chemistry analyzers, incubator, and oven
c) Immunology and serology equipment, microbiology equipment, and special chemistry equipment
d) Bone marrow studies equipment, immunohematology and blood banking equipment, and automated
chemistry analyzer
e) None of the above
Answer: c) Immunology and serology equipment, microbiology equipment, and special chemistry
equipment
Explanation: A laboratory in the tertiary category requires immunology and serology equipment,
microbiology equipment, and special chemistry equipment, in addition to the equipment required in the
secondary category.
1. What is the minimum floor area requirement for a Serofuge laboratory?
a) 50 sq.m.
b) 55 sq.m.
c) 60 sq.m.
d) 65 sq.m.
e) 70 sq.m.
Answer: c) 60 sq.m.
Explanation: The minimum floor area requirement for a Serofuge laboratory is 60 sq.m.
2. What is a National Reference Laboratory?
a) A laboratory in a private hospital designated by the DOH to provide special diagnostic functions and
services for certain diseases.
b) A laboratory in a government hospital designated by the DOH to provide special diagnostic functions
and services for certain diseases.
c) A laboratory in a government hospital designated by the DOH to provide general diagnostic functions
and services for all diseases.
d) A laboratory in a private hospital designated by the DOH to provide general diagnostic functions and
services for all diseases.
e) None of the above.
Answer: b) A laboratory in a government hospital designated by the DOH to provide special diagnostic
functions and services for certain diseases.
Explanation: A National Reference Laboratory is a laboratory in a government hospital designated by
the DOH to provide special diagnostic functions and services for certain diseases. It also provides
referral services, provision of confirmatory testing, assistance for research activities, implementation of
External Quality Assurance Programs (EQAP) of the government, resolution of conflicts regarding test
results of different laboratories, and training of medical technologists on certain specialized procedures
that require standardization.
3. What is Republic Act No. 4688?
a) 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.
b) An act regulating the operation and maintenance of clinical laboratories and requiring the registration
of the same with the department of education, providing penalty for the violation thereof, and for other
purposes.
c) An act regulating the operation and maintenance of clinical laboratories and requiring the registration
of the same with the department of labor, providing penalty for the violation thereof, and for other
purposes.
d) An act regulating the operation and maintenance of clinical laboratories and requiring the registration
of the same with the department of agriculture, providing penalty for the violation thereof, and for other
purposes.
e) None of the above.
Answer: a) 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.
Explanation: Republic Act No. 4688 is 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. It includes provisions on registration and licensing,
laboratory should be headed by a duly registered physician, issuance of rules and regulations, and
punishment for violations.
1. What is the punishment for violating Section 4 of the Rules and Regulation Governing the
Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines?
a) Imprisonment for not less than one week but not more than one month
b) Imprisonment for not less than one month but not more than one year (Answer)
c) Imprisonment for not less than one year but not more than five years
d) Fine of not less than 5K nor more than 10K
e) Fine of not less than 1K nor more than 5K
Explanation: Section 4 of the Rules and Regulation Governing the Establishment, Operation, and
Maintenance of Clinical Laboratories in the Philippines states that the punishment for violating any
provision of the act is imprisonment for not less than one month but not more than one year, or a fine of
not less than 1K nor more than 5K.
2. Who exercises the regulatory functions under the Rules and Regulation Governing the
Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines?
a) Bureau of Research and Laboratories (BRL)
b) Department of Health (DOH) through the Bureau of Health Facilities and Services (BHFS) (Answer)
c) Health Regulation Cluster
d) Bureau of Health Services
e) Bureau of Health Facilities
Explanation: Section 2 of Administrative Order No. 59 s. 2001 states that the Department of Health
(DOH) through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster
shall exercise the regulatory functions under these rules and regulations.
3. What is the purpose of the Rules and Regulation Governing the Establishment, Operation, and
Maintenance of Clinical Laboratories in the Philippines?
a) To promote the establishment of clinical laboratories
b) To ensure the availability of clinical laboratories
c) To ensure the proper management of clinical laboratories (Answer)
d) To regulate the fees charged by clinical laboratories
e) To provide guidelines for the operation of clinical laboratories
Explanation: Section 3 of Administrative Order No. 59 s. 2001 states that the purpose of the Rules and
Regulation Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the
Philippines is to protect and promote the health of the people by ensuring availability of clinical
laboratories that are properly managed.
ng
5. Blood Chemistry
b. Secondary – provides additional service capabilities such as
1. Serology
2. Immunology
3. Microbiology
4. Histopathology
5. Cytology
1. What is the purpose of the regulations on clinical laboratories?
a. To limit the number of clinical laboratories
b. To ensure that clinical laboratories have adequate resources
c. To promote the use of alternative medicine
d. To reduce the number of medical tests
e. To increase the cost of medical tests
Answer: b. To ensure that clinical laboratories have adequate resources. Explanation: The purpose of
the regulations is to protect and promote the health of the people by ensuring availability of clinical
laboratories that are properly managed with adequate resources.
2. Which laboratories are covered by the regulations?
a. All government laboratories
b. All laboratories doing acid fast bacilli microscopy
c. All laboratories doing malaria screening
d. All entities performing the activities and functions of clinical laboratories
e. All laboratories doing cervical cancer screening
Answer: d. All entities performing the activities and functions of clinical laboratories. Explanation: The
regulations shall apply to all entities performing the activities and functions of clinical laboratories.
3. How are laboratories classified by function?
a. Hospital-based and non-hospital-based
b. Primary and secondary
c. Clinical pathology and anatomic pathology
d. Serology and immunology
e. Routine hematology and routine urinalysis
Answer: c. Clinical pathology and anatomic pathology. Explanation: Laboratories are classified by
function into clinical pathology and anatomic pathology.
4. How are laboratories classified by institutional character?
a. Hospital-based and non-hospital-based
b. Primary and secondary
c. Clinical pathology and anatomic pathology
d. Serology and immunology
e. Routine hematology and routine urinalysis
Answer: a. Hospital-based and non-hospital-based. Explanation: Laboratories are classified by
institutional character into hospital-based laboratory and non-hospital-based laboratory.
5. What is the difference between primary and secondary laboratories?
a. Primary laboratories provide more services than secondary laboratories
b. Secondary laboratories provide more services than primary laboratories
c. Primary laboratories are hospital-based while secondary laboratories are non-hospital-based
d. Secondary laboratories are more compliant with quality standards than primary laboratories
e. Primary laboratories are more efficient than secondary laboratories
Answer: b. Secondary laboratories provide more services than primary laboratories. Explanation:
Laboratories are classified by service capability into primary and secondary. Secondary laboratories
provide additional service capabilities compared to primary laboratories.
1. Which category of laboratory provides the minimum service capabilities such as routine hematology
and blood typing?
a. Primary
b. Secondary
c. Tertiary
d. Quaternary
e. None of the above
Answer: a. Primary
Explanation: According to Administrative Order No. 59 s. 2001, Section 5 -Classification of
Laboratories, the primary category provides the minimum service capabilities such as routine
hematology and blood typing.
2. Which category of laboratory provides the minimum service capabilities of a primary category and
routine clinical chemistry?
a. Primary
b. Secondary
c. Tertiary
d. Quaternary
e. None of the above
Answer: b. Secondary
Explanation: According to Administrative Order No. 59 s. 2001, Section 5 -Classification of
Laboratories, the secondary category provides the minimum service capabilities of a primary category
and routine clinical chemistry.
3. Which category of laboratory provides the secondary service capabilities and special chemistry,
special hematology, immunology/serology, and microbiology?
a. Primary
b. Secondary
c. Tertiary
d. Quaternary
e. None of the above
Answer: c. Tertiary
Explanation: According to Administrative Order No. 59 s. 2001, Section 5 -Classification of
Laboratories, the tertiary category provides the secondary service capabilities and special chemistry,
special hematology, immunology/serology, and microbiology.
4. What is the policy regarding the construction and operation of a clinical laboratory?
a. An approved permit to construct and design layout of a clinical laboratory shall be secured from the
BHFS prior to submission of an application for a Petition to Operate.
b. No clinical laboratory shall be constructed unless plans have been approved and construction permit
issued by the BHFS.
c. A clinical laboratory shall operate with a valid permit.
d. All of the above
e. None of the above
Answer: d. All of the above
Explanation: According to Administrative Order No. 59 s. 2001, Section 6 –Policies, all of the above
policies are required for the construction and operation of a clinical laboratory.
inistrative Order No. 59 s. 2001
Section 7 –Requirements and Procedures for Application of
Permit to Construct and License to Operate
3. The clinical laboratory shall comply with the minimum
requirements for physical plant, equipment, personnel, and
quality assurance as specified in ANNEX A.
4. The clinical laboratory shall submit a notarized application form
for renewal of license to operate at least sixty (60) days prior to
the expiration of the current license.
Which of the following statements is true regarding the construction of a clinical laboratory?
A. A clinical laboratory can be constructed without any plans or permits.
B. Plans must be approved and a construction permit must be issued by the BHFS before construction
can begin.
C. A clinical laboratory can be constructed with only a letter of application to the Director of BHFS.
D. Four sets of site development plans and floor plans are not required for the construction of a clinical
laboratory.
E. DTI/SEC registration is not required for private clinical laboratories.
Answer: B. Plans must be approved and a construction permit must be issued by the BHFS before
construction can begin.
Explanation: According to Section 7 of Administrative Order No. 59 s. 2001, a clinical laboratory cannot
be constructed unless plans have been approved and a construction permit has been issued by the
BHFS.
1. What is the name of the application form needed to establish, operate, and maintain a clinical
laboratory?
a. Application for License Renewal
b. Petition to Construct a Laboratory
c. Application for New License
d. Permit and License Fees
e. Penalties
Answer: c. Application for New License
Explanation: According to the given content, the notarized application form needed to establish,
operate, and maintain a clinical laboratory is called "Petition to Establish, Operate and Maintain a
Clinical Laboratory."
2. What is the name of the application form needed for the renewal of a license to establish, operate,
and maintain a clinical laboratory?
a. Application for License Renewal
b. Petition to Construct a Laboratory
c. Application for New License
d. Permit and License Fees
e. Penalties
Answer: a. Application for License Renewal
Explanation: As per the given content, the application form needed for the renewal of a license to
establish, operate, and maintain a clinical laboratory is called "Application for Renewal of License to
Establish, Operate and Maintain a Clinical Laboratory."
3. When should the application for renewal of a license be filed?
a. Within 60 days before the expiry date of the license
b. Within 90 days before the expiry date of the license
c. Within 120 days before the expiry date of the license
d. Within 180 days before the expiry date of the license
e. Within 365 days before the expiry date of the license
Answer: b. Within 90 days before the expiry date of the license
Explanation: According to the given content, the application for renewal of a license should be filed
within 90 days before the expiry date of the license.
4. Which section of Administrative Order No. 59 s. 2001 provides the requirements and procedures for
the application of permit to construct and license to operate?
a. Section 2
b. Section 4
c. Section 5
d. Section 7
e. Section 9
Answer: d. Section 7
Explanation: The given content clearly states that Section 7 of Administrative Order No. 59 s. 2001
provides the requirements and procedures for the application of permit to construct and license to
operate.
5. What is the purpose of Permit and License Fees?
a. To establish a clinical laboratory
b. To renew a license to operate a clinical laboratory
c. To pay for penalties
d. To pay for the construction of a laboratory
e. To pay for the license to operate a clinical laboratory
Answer: e. To pay for the license to operate a clinical laboratory
Explanation: As per the given content, Permit and License Fees are used to pay for the license to
operate a clinical laboratory.