DOCUMENTED POLICIES, PROTOCOLS AND GUIDELINES IN THE OPERATION AND

MAINTENANCE OF LABORATORY

OBJECTIVE:

These rules and regulations shall serve as the guidelines in the licensing of Diagnostic Clinical
laboratories in the Philippines which shall ensure accountability of the laboratory on generation of
accurate, precise and reliable laboratory results in a timely manner through continuous
compliance.

POLICIES:

 An approved permit to construct and design lay-out of a clinical laboratory shall be secured
from DOH prior to submission of an application for a License to Operate.
 No clinical laboratory shall be constructed unless plans have been approved and
construction permit issued by the DOH.
 A clinical laboratory shall operate with a valid license issued by DOH, based on compliance
with the minimum licensing requirements.
 The clinical laboratory shall be organized and managed to provide effective and efficient
laboratory services.
 The clinical laboratory shall provide adequate and appropriate safety practices for its
personnel and clients.

GUIDELINES:

 All Clinical Laboratories (CL) shall secure DOH-LTO prior to its operation and must comply
with the minimum regulatory standards and requirements at all times.
 The DOH-LTO shall be secured from the DOH regulatory office in accordance with DOH
guidelines.
 The head of the CL shall be a Pathologist certified by a professional organization recognized
as the Accredited Professional Organizations/Accredited Integrated Professional
Organizations of the Professional Regulation Commission. The head of laboratory shall
ensure the optimal overall operations and maintenance of the CL.
 There shall be an adequate number of competent personnel assigned in the different
services provided by the DOH-licensed CL.
 All CLs shall make their prices for laboratory services accessible to the public as mandated
by the UHC law and related DOH issuances.
 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.
 The CL shall be compliant with the prescribed standards and requirements , Assessment
Tool for Licensing Clinical Laboratories and other relevant laws and issuances.
 The DOH-LTO may be revoked, suspended or modified in full or in part for any false
statement by the applicant, or as shown by the record of inspection or for a violation of, or
failure to comply with any of the terms and conditions and provisions of these rules and
regulations.
 A completely filled out application form for DOH-PTC (downloadable at
www.hfstb.doh.gov.ph), whether manual or online, shall be submitted to the DOH
regulatory offices.
 A DOH-PTC shall be required for construction of new CL and for renovation or expansion of
existing CL including change in ownership and transfer of location.
 The application shall be processed in accordance with the procedural guidelines set forth in
A.O. No. 2016-0042, also known as, “Guidelines in the Application for Department of Health
Permit to Construct.
 Any person, firm or corporation desiring to establish, operate and maintain CL shall submit
an accomplished application form to HFSRB/CHD-RLED in accordance with the current
DOH guidelines, whether manual or through the Online Licensing and Regulatory System
(OLRS), once it is fully functional.
 Upon receipt of the complete application forms, the HFSRB/CHD-RLED representative, in
accordance with the current DOH guidelines, reviews the application and conducts an on-
site assessment of the laboratory to determine full compliance with the standards and
technical requirements.
 If, upon assessment, the laboratory is not fully compliant with the licensing requirements,
the HFSRB/CHD-RLED, in accordance with the current DOH guidelines, shall provide a
written report outlining the laboratory’s deficiencies. The laboratory must comply with the
deficiencies within thirty (30) days. Otherwise, the application shall automatically be
denied.
 The DOH-LTO, whether initial or renewal, shall only be issued after the HFSRB/CHD-RLED,
in accordance with the current DOH guidelines, has determined that the laboratory is fully
compliant.
 Submitted complete applications that are not processed within twenty (20) days by the
HFSRB/CHD-RLED, in accordance with the current DOH guidelines, due to force majeure,
shall automatically be granted the LTO, and a post-licensing visit shall be scheduled.
 The DOH-LTO is non-transferable and a new application for DOH-LTO shall be required in
case of change of ownership or transfer of location.
 The HFSRB/CHD-RLED, in accordance with the current DOH guidelines, shall be notified in
writing of any change in management name, ownership, or headship or laboratory
personnel. Failure to notify of any substantial change in the condition of the laboratory, i.e.
changes in the physical plant, equipment, or personnel, in writing within fifteen (15) days,
may be a basis for the suspension or revocation of the DOH-LTO.
 Different branch(es) of a CL, even if owned by the same entity shall secure separate DOH-
LTO.
 The DOH-LTO shall be placed in an area that can be readily seen by the public, at all times.
 If upon monitoring visit, the CL is found to be violating any of the rules and regulations
stated herein relative to its operation, the HFSRB/CHD-RLED in accordance with the
current DOH guidelines, may immediately impose preventive suspension.
 Clinical Laboratories continuously comply with the rules and regulations, licensing
standards and requirements for CL.
 Clinical Laboratories shall participate in EQAP that may be administered by a designated
NRL.
 A CL shall be sanctioned and penalized by the HFSRB/CHD Director upon violation of any of
these guidelines and its related issuances and laws, or upon committal
(commission/omission) of prohibited acts by the persons owning or operating the CL,
and/or the persons under their authority.
 Any person who operates a CL without securing the necessary DOH-PTC and corresponding
DOH-LTO shall be issued a Cease-and-Desist Order (CDO) and shall pay the administrative
penalty of Fifty thousand pesos (Php50,000.00).
 In case of complaints, the CL, upon receipt of such by HFSRB/CHD-RLED shall be given due
process wherein an investigation shall be conducted and the appropriate sanctions for its
violation/s. A 60-day preventive suspension may be given to the CL during the investigation
depending on the seriousness of the violation.
 Any CL or any of its personnel not amenable with the decision of the HFSRB/CHDRLED may,
within ten (10) days after the receipt of notice of decision, file a notice of appeal to the Head
of the Health Regulation Team (HRT). All pertinent documents and records of the appellant
shall then be elevated by HFSRB/CHD-RLED to the HRT. The decision of the Head of the
HRT, if still contested may be brought on a final appeal to the Secretary of Health, whose
decision shall be final and executory.
 CL with revoked licenses can only re-apply after one year from the date of LTO revocation.
 Any person authorized or licensed to conduct clinical laboratory tests, who issues false or
fraudulent laboratory test results knowingly, willfully or through gross negligence shall not
be allowed to own, manage, operate, or be an analyst of any DOH licensed CL.