MEDTECH LAWS & BIOETHICS L2

ADMINISTRATIVE ORDER NO. 2021-0037

DEFINITION OF TERMS Radioimmunoassay for thyroid function tests and Prostate

Specific Antigen shall be under the DOHlicensed CL.
APPLICANT
g. The head of the CL shall be a pathologist certified by
 refers to any natural juridical person, government a professional organization recognized as the Accredited
instrumentalities, partnership, corporation or agency Professional Organizations/Accredited Integrated
seeking a LTO and maintain a clinical laboratory. Professional Organizations of the Professional Regulation
Commission. The head of laboratory shall ensure the
ASSESSMENT TOOL optimal overall operations and maintenance of the CL and if
applicable, of its SCL and MCL.
 the checklist which prescribes the minimum standards
and requirements for licensure of clinical laboratory. h. There shall be an adequate number of competent
personnel assigned in the different services provided by the
DOH-licensed CL, which includes the MCL, SCL, remote
collection activities, if applicable.

i. CLs that are operated and maintained exclusively for

research and teaching purposes shall be required to
register with the DOH-HFSRB.

j. The DOH designated NRL shall be covered by the

license of the CL of the hospital where they are affiliated
with. Independent NRLs, or those designated by DOH but
are not affiliated with any DOH-regulated health facility,
shall secure a DOH-LTO from HFSRB.

k. All CLs shall make their prices for laboratory services

accessible to the public as mandated by the UHC law and
related DOH issuances.

l. At the Central Office, the Director IV, or in his/her

absence or unavailability or when delegated, the Director III
of HFSRB, shall approve the issuance of the DOH-LTO of
the CL.

m. At the CHD, the Director IV, shall approve the

issuance of the DOH-LTO of the CL.

n. In the advent of new technologies or diagnostic

GENERAL GUIDELINES OF AO NO. 2021-0037 platforms that shall affect the current licensing standards for
CL, Department Circulars shall be issued, as needed, as
a. All CL shall secure DOH-LTO prior to its operation supplements to this Order. The CL shall be compliant with
and must comply with the minimum regulatory standards the prescribed standards and requirements (Annex A),
and requirements at all times. Assessment Tool for Licensing Clinical Laboratories (Annex
Bl and B2) and other relevant laws and issuances. These
b. The DOH-LTO shall be secured from the DOH standards shall also apply to MCL and SCL. The DOH-LTO
regulatory office in accordance with DOH guidelines. may be revoked, suspended or modified in full or in part for
any false statement by the applicant, or as shown by the
c. Only DOH-licensed institution-based CL may have a record of inspection or for a violation of, or failure to comply
SCL which shall be located within the premises of the with any of the terms and conditions and provisions of these
regulated health facility. rules and regulations.

d. A DOH-licensed CL may have MCL services as listed DEPARTMENT OF HEALTH – LICENSE TO OPERATE
in Section IV of Annex A, provided, they adhere to standard
testing protocols.  A formal authorization issued by the DOH to an individual,
partnership, corporation, association, or any government
e. The DOH-licensed CL shall not perform examinations agency/unit seeking to perform laboratory tests in
or testing beyond its authorized service capability. However, compliance with the requirements prescribed in this
it may be allowed to offer laboratory services other than the Order.
respective stipulated minimum services, such as not limited
to MCL, SCL, confirmatory testing for Glucose-6-Phosphate POL
Dehydrogenase (G6PD) Deficiency, and Rapid HIV
Diagnostic Algorithm (rHIVda), provided that the additional required to secure a clinical laboratory license when it
services have been approved and indicated as add-on undertakes any or all of the ff:
services in the DOH-LTO of the CL.
 Issue official lab results
f. Unit/Section of health facilities performing diagnostic  Perform more than monitoring exams
CL tests such as, but not limited to, arterial blood gas and/or  Cater not only to physician’s own patients

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ADMINISTRATIVE ORDER NO. 2021-0037

POCT

conducted in the hospital, required to be under the

management and supervision of the licensed clinical laboratory
of the respective hospital.

SPECIFIC GUIDELINES OF AO NO. 2021 - 0037

CLASSIFICATION OF LABORATORIES

CLASSIFICATION BY OWNERSHIP

 Government: Operated and maintained partially or

wholly, by the national government, LGU, any other
political unit, department or division.

 Private: Owned, established and operated by any

individual, corporation, association or organization.

CLASSIFICATION BY INSTITUTIONAL CHARACTER

 Institution-based: A laboratory that is located within the

premises and operates as part of DOH licensed facility.

 Freestanding: A laboratory that operates independently

and is not attached to any DOH licensed facility

CLASSIFICATION BY FUNCTION

 Clinical Pathology: deals with chemical and cellular

analyses of blood and other body fluids includes, but not
limited to:

o Clinical Chemistry
o Clinical Microscopy
o Toxicology
o Therapeutic drug monitoring
o Immunology and Serology
o Hematology and Coagulation
o Identification and examination of microbes and
parasites (bacteriology/ parasitology/ mycology/
virology)

 Anatomic Pathology: provides processing and

examination of surgical specimens as to the physical
appearance and microscopic structure of tissues, such
as, but not limited to:

o Surgical Pathology
o Cytopathology
o Immunohistochemical techniques
o Autopsies and forensic pathology

 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/or to guide the prevention and treatment and
tools of molecular biology as they are applied to
diagnostic medicine in the laboratory.

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ADMINISTRATIVE ORDER NO. 2021-0037

CLASSIFICATION BY SERVICE CAPABILITY

 Clinical Laboratory for Clinical and Anatomic
Pathology

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 Clinical Laboratory for Anatomic Pathology Only: provide a written report outlining the laboratory’s
deficiencies.
o Provides services for any of the following, but not
limited to cytology and histopathology. o The laboratory must comply with the deficiencies
within thirty (30) days. Otherwise, the application
 Clinical Laboratory for Pathology Only: shall automatically be denied.
o Provides services for genetics,
immuno/hematopathology and infectious disease.  The DOH-LTO, whether initial or renewal, shall only be
COVID-19 testing laboratories shall be covered by issued after the HFSRB/CHD-RLED, has determined that
another Order the laboratory is fully compliant.

PROCEDURAL GUIDELINES OF AO NO. 2021 - 0037  Submitted complete applications that are not processed
within twenty (20) days by the HFSRB/CHD-RLED, due
PERMIT TO CONSTRUCT (PTC) to force majeure, shall automatically be granted the LTO,
and a post-licensing visit shall be scheduled.
 A completely filled out application form for DOH-PTC
(downloadable at www.hfsrb.doh.gov.ph), whether
 Only DOH licensed CL identified by the program and has
manual or online, shall be submitted to the DOH
already secured a certificate of “Certified rHIVda
regulatory offices,
Confirmatory Laboratory (CrCL)” from the
NRLSLH/SACCL or its designated regional counterpart,
 A DOH-PTC shall be required for construction of new CL
shall be allowed to apply for a license CrCL.
and for renovation or expansion of existing CL, including
change in ownership and transfer of location.
 A DOH-licensed hospital-based tertiary CL, already
certified by the NSRC, may apply as a G6PD Deficiency
 The application shall be processed in accordance with
confirmatory laboratory to HFSRB.
the procedural guidelines set forth in A.O. No. 2016-0042,
also known as, “Guidelines in the Application for
 For institution-based CL, the One-Stop Shop (OSS)
Department of Health Permit to Construct (DOH-PTC).”
Licensing System, pursuant to Administrative Order No.
LICENSE TO OPERATE 2018-0016 dated June 4, 2018, titled “Revised
Guidelines in the Implementation of the One-Stop Shop
 Any person, firm or corporation desiring to establish, Licensing System,” shall be followed.
operate and maintain CL shall submit an accomplished
application form to HFSRB/CHD-RLED  The DOH-LTO is non-transferable and a new application
for DOH-LTO shall be required in case of change of
 A complete application for DOH-LTO of CL shall consists ownership or transfer of location.
of the following:
 The HFSRB/CHD-RLED, in accordance with the current
o Completely filled out application Form 1 and its DOH guidelines, shall be notified in writing of any change
attachments (downloadable at in management name, ownership, or headship or
www.hfsrb.doh.gov.ph); laboratory personnel.

 Notarized Acknowledgement o Failure to notify of any substantial change in the

 Any of the following proof of ownership and condition of the laboratory, i.e., changes in the
name of health facility physical plant, equipment, or personnel, in writing
within fifteen (15) days, may be a basis for the
DTI/SEC/CDA Registration including Articles suspension or revocation of the DOH-LTO.
of Incorporation/ Cooperation and By-Laws
Enabling Act/ LGU Resolution (for  Different branch(es) of a CL, even if owned by the same
government health facility) entity shall secure separate DOH-LTO.

 Accomplished Self-Assessment Tool  Application for DOH-LTO shall be in compliance with AO

 Health Facility Geographic Form No. 2019-0004 dated April 30, 2019, titled “Guidelines on
 Copy of official receipt payment. the Annual Cut-off Dates for Receipt of Complete
 Certificate from NRL-SLH/SACCL for rtHIVdA Applications for Regulatory Authorizations Issued by the
Confirmatory, if applicable. Department of Health.”
 Certificate from Newborn Screening Reference
Center (NSRC), if applicable.  The DOH-LTO shall be placed in an area that can be
readily seen by the public, at all times
 Upon receipt of the complete application forms, the
HFSRB/CHD-RLED representative, in accordance with VALIDITY
the current DOH guidelines, reviews the application and
conducts an on-site assessment of the laboratory to  The DOH-LTO is valid for one (1) year.
determine full compliance with the standards and
technical requirements.  COR for CL that is operated and maintained exclusively
for research and teaching purposes shall be required to
 If, upon assessment, the laboratory is not fully compliant register with the DOH-HFSRB every three (3) years.
with the licensing requirements, the HFSRB/CHD-RLED,
in accordance with the current DOH guidelines, shall
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VALIDATIONS, SANCTIONS AND APPEAL  There shall be staff development and continuing
education program at all levels of organization to
 For non-institution-based CL that are not under the upgrade the knowledge, attitude, and skills of staff.
OSSOLS, the following are the penalties and sanctions
that shall be imposed for the commission of any of the
violations:

o 1 st offense: Stern warning

o 2 nd offense: Thirty thousand pesos (Php 30,000.00)
o 3 rd offense: Fifty thousand pesos (Php 50,000.00)
o 4 th offense: Revocation of DOH-LTO

 For CL that are part of hospitals and other facilities, AO

No. 2007-0022, dated June 6, 2007, titled “Violations
under the One-Stop Shop Licensure System for
Hospitals,” sanctions shall be governed by the
aforementioned Order.

 Any person who operates a CL without securing the

necessary DOH-PTC and corresponding DOH-LTO shall MCL Personnel
be issued a Cease-Desist Order (CDO) and shall pay the
MCL shall has its own set of personnel, which includes the
administrative penalty of Fifty thousand pesos (Php
following, but not limited to:
50,000.00)
o Registered Medical Technologist – number will
 For CL that CL with revoked licenses can only re-apply depend on the anticipated workload
after one year from the date of LTO revocation.
o Support staff such as, but not limited to, driver and
 Ay person authorized or licensed to conduct clinical laboratory technician.
laboratory tests, who issues false or fraudulent laboratory
test results knowingly, willfully or through gross EQUIPMENT
negligence shall not be allowed to own, manage, operate,
or be an analyst of any DOH-Licensed Clinical  There shall be available and operational equipment to
Laboratory. provide the laboratory examinations that the laboratory is
licensed for.
STANDARDS
 There shall be a calibration, preventive maintenance and
HUMAN RESOURCES repair program for the equipment.
 Every clinical laboratory shall be headed and managed
 There shall be a contingency plan in case of equipment
by a Pathologist, certified either as a Clinical Pathologist,
breakdown.
an Anatomic Pathologist or both by the Philippine Board
of Pathology.

 The head of the laboratory shall have administrative and

technical supervision of the activities in the laboratory.

 The head of the laboratory shall supervise the staff in

accordance to the standards set by the Philippine Society
of Pathologists.

 There shall be an adequate number of medical

technologists and other health professionals with
documented training and experience to conduct the
laboratory procedures. The number of staff shall depend
on the workload and the services being provided.

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ADMINISTRATIVE ORDER NO. 2021-0037

INFORMATION MANAGEMENT

ADMINSTRATIVE POLICES AND PROCEDURES

 The clinical laboratory shall have written policies and

procedures for the provision of laboratory services and
for the operation and maintenance of the laboratory.

TECHNICAL PROCEDURES

 There shall be documented technical procedures for

services provided in each Section of the laboratory,
which will ensure the quality of laboratory results.

QUALITY ASSURANCE PROGRAM

 There shall be an Internal Quality Assurance Program

which shall include:

o An Internal Quality Control Program for technical

procedure

o An Internal Quality Assurance Program for inputs,

processes and outputs

o A Continuous Quality Improvement Program covering

all aspects of laboratory performance.

 The clinical laboratory shall participate in an EQAP

administered by designated NRL or in other local and
international EQAP approved by the DOH.

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