Evaluate: Compare the requirements for the licensure of general clinical laboratory and a
COVID-19 testing laboratory. List down the difference and explain rationale of the
differences.
Licensure Of General Clinical Laboratory
- DOH-Permit to construct
- DOH-License to operate
- Complied with the standards and
technical requirements formulated by
the Bureau of Health Facilities and
Services (BHFS)
- Clinical laboratory shall be managing
effectively and efficiently and in
accordance with its vision, mission, and
objectives.
- Clinical laboratory shall be organized
to provide effective and efficient
laboratory services.
- Headed and managed by a clinical
and/or Anatomic Pathologist by the
Philippine-Board of Pathology (PBP)
- Adequate number of medical
technologists and other health
professionals with documented training
and experience to conduct laboratory
procedures.
- Adequate facilities shall be in place for
the safe and efficient of the clinical
laboratory
- Adequate equipment shall be in good
working order
- Adequate reagents and supplies shall be
in good working order.
- Participation in an External Quality
Assessment Program (EQAP)
- When Laboratory examination are
referred to and provided by an
outside clinical laboratory, the
referring laboratory shall obtain
assurance of the quality of services
provided through an agreement or
its equivalent with a licensed
clinical laboratory performing the
laboratory services needed.
Licensure of COVID-19 testing laboratory
- License by the DOH
- COVID-19 testing laboratories shall
ensure that the environment is safe
for its patients
- It should have a separate unit or a
designated working area (must be
separated from general section)
- Adhere to BioSafety and BioSecurity
imposed by the WHO
- Staff should have their appropriate
trainings
- The equipment, kits, reagents should
be registered to the FDA
- Reporting of results should be noted
how many tests are conducted and to
all tested done how many were
positive and how many tested were
negative, promptly reported to
authorized personnel
- Head of the COVID-19 Testing
Laboratory shall have the overall
supervision on technical procedures
as well as on the administrative
laboratory management
- Adequate space with a unidirectional
workflow for the safe and efficient
operation of the COVID-19 testing
laboratory.
- There shall be adequate equipment
which are all in good working
condition.
- There shall be reagents and supplies
which are all in good working
condition and sufficient enough for
the operations.
- Policies and procedure for provision
of laboratory services are formulated
for the operation and maintenance of
the laboratory.
- When COVID-19 testing are referred
to and provided by another COVID-
19 testing laboratory, the referring
 COVID-19 testing laboratory shall
obtain assurance of the quality of
services

A COVID-19 testing laboratory must have a separate working area, separated from
other general sections to prevent transmission of the virus. Obtaining assurance of the
quality services is different because both of them provide different service to people.
COVID-19 testing laboratory ensures that the environment is safe for its patients and staff
including general public to prevent any transmission and to guarantee that there will be no
people acquiring the COVID-19.