Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

JAN 20 2023

ADMINISTRATIVE ORDER
No.
ae
- 2023 - D004

SUBJECT: New Rules and Regulations Governing the Licensure of COVID-19

Testing Laboratories Performing Nucleic Acid Amplification Test
(NAAT)

RATIONALE

The Coronavirus disease 2019 (COVID-19) pandemic is

still considered a threat over the
world after approximate of two (2) years. As of September 11, 2022, according to the
World Health Organization’s (WHO) COVID-19 Weekly Epidemiological Update, over
605 million confirmed cases were reported globally. In the Philippines, there is a
continuous rise in the number of cases wherein the Department of Health (DOH) —
National COVID-19 Case Bulletin recorded 15,379 new cases from September 5-11, 2022.

Prevention of person-to-person transmission is critical in the control and mitigation of

COVID-19, and early detection through testing is vital in identifying the affected
individuals. Currently, the reference standard for detecting Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, are Nucleic
Acid Amplification Tests (NAAT) such as Real Time Reverse Transcriptase — Polymerase
Chain Reaction (rRT-PCR), as recommended by
the WHO. The DOH issued the standards
and requirements in
obtaining license to operate a COVID-19 testing laboratory (COVID-
19 TL), Administrative Order (AO) No. 2020-0014 titled “Guidelines in Securing a
License to Operate a COVID-19 Testing Laboratory in the Philippines,” and its
amendments, to ensure accountability of COVID-19 TL on generation of accurate and
precise results. From one (1) WHO-accredited laboratory capable of performing the test,
the Research Institute for Tropical Medicine (RITM) in 2020, there are now 349 DOH-
licensed COVID-19 TL around the country as of November 7, 2022, allowing the
country’s testing capacity to expand.

Feedbacks from key stakeholders were obtained and provided to DOH to update the
current licensing standards and requirements of COVID-19 TL part of monitoring the as
implementation of DOH issuances and polices. As a result, the existing guidelines in
securing a License-to-Operate for COVID-19 TL in the Philippines have been reviewed
and updated. In addition, the term “Nucleic Acid Amplification Test” was adopted to
encompass the other established and accepted COVID-19 molecular diagnostic platforms.

Il. OBJECTIVE

This Order intends to provide new guidelines in the regulation of NAAT-based COVID-
19 TL in
the Philippines to better ensure accountability in the generation of accurate and
precise results, ultimately safeguarding the safety of the public and personnel. its
Ill. SCOPE OF APPLICATION ?
ell
This Order shall apply to all government and private-owned COVID-19 TL in the
Philippines performing only NAAT for SARS-CoV-2 detection. y

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila @ Trunk Line 651-7800 local 1108, 1111, 1112, 1113”
Direct Line: 711-9502; 711-9503 Fax: 743-1829 e URL: http://www.doh.goy.ph; e-mail:
 This Order shall also apply to Bangsamoro Autonomous Region in Muslim Mindanao
(BARMM) subject to the applicable provisions of Republic Act (RA) No. 11054 or the
“Bangsamoro Organic Act” and subsequent rules and policies issued by the Bangsamoro
Government.

IV. DEFINITION OF TERMS

A. Applicant - refers to any natural or juridical person, government

instrumentalities/agencies, partnership, corporation or agency seeking a DOH-
License-to-Operate and maintain a NAAT COVID-19 TL.

COVID-19 Testing Laboratory (COVID-19 TL) refers to a DOH-licensed

—-

COVID-19 testing facility involved in the (a) pre-analytical, (b) analytical, and (c)
post-analytical procedures for the detection of SARS-CoV-2 genetic materials through
NAAT on specimens from the human body to obtain information for the prevention,
diagnosis and treatment, and surveillance protocols for COVID-19.

Department of Health-License te Operate (DOH-LTO) refers to a formal

—

authorization issued by the DOH through the Health Facilities and Services Regulatory
Bureau (HFSRB) or Center for Health Development — Regulation, Licensing and
Enforcement Division (CHD-RLED) toan individual, partnership, corporation or
association seeking to perform SARS-CoV-2 detection ina NAAT COVID-19 TL in
compliance with the requirements prescribed in this Order (AO No. 2021-0037).

DOH-Permit to Construct (DOH-PTC) — refers to a permit issued by DOH through

HFSRB or CHD-RLED
to an applicant who will establish and operate a NAAT
COVID-19 TL, upon compliance with required documents set forth in this Order prior
to actual construction of the said facility. A DOH-PTC is also required for health
facility with substantial alteration, expansion, renovation, or for additional services
beyond their service capability. It is a prerequisite for DOH-LTO (AO No. 2016-0042).

Certificate of Proficiency — refers to a Certification from RITM signed by the Office

of the Undersecretary of Field Implementation and Coordination Team (FICT) NCR
and Luzon (COVID-19 Laboratory Operations Team Lead) that the COVID-19 TL has
completed and passed the proficiency testing. It is required prior to the operation of
the COVID-19 TL.

Nucleic Acid Amplification Test (NAAT) — refers to a molecular test that amplifies
or makes multiple copies of detected target genetic material from a given sample. The
methods include, but are not limited to:
1. Polymerase chain reaction (PCR-based) — refers to a technique of amplifying target
sequence from DNA template in an exponential manner generally with the aid of
target-specific primers, dNTPs, Mg ions, a Taq polymerase enzyme and a PCR
thermal cycler; such as rRT-PCR and Multiplex PCR
2. Isothermal amplification methods (non-PCR-based) — refers to amplification of a
specific nucleic acid fragment at constant temperature with the use of a heat block
instead of a thermal cycler; such as loop-mediated isothermal amplification
(LAMP) and transcription-mediated amplification (TMA).

Referral — refers to sending-out of specimens for testing by a DOH-licensed COVID-

19 TL to other DOH-licensed COVID-19 TL
in
case of surge in number ofspecimens,
machine breakdown, or lack of supplies, pursuant to the latest zoning guidelines of the
COVID-19 Laboratory Network.
¥ 4 2
H. Remote Collection — refers to all sample collection activities for SARS-CoV-2
detection using NAAT, done outside and not within the DOH-licensed COVID-19 TL.
1. Freestanding Collection Sites — refer to collection sites not owned by any DOH-
licensed COVID-19 TL with the sole purpose of
collecting specimens/samples for
COVID-19 testing. A valid Memorandum/Memoranda of Agreement (MOA) with
DOH-licensed COVID-19 TL shall be required for these freestanding collection
sites.
2. Satellite Collection Sites — refers to remote collection site owned by the DOH-
licensed COVID-19 TL but located outside the premises/compound of the DOH-
licensed COVID-19 TL.

GENERAL GUIDELINES

A. COVID-19 NAAT testing shall only be performed in a DOH-licensed NAAT-based

COVID-19 TL.

The DOH-LTO for a NAAT-based COVID-19 TL shall only be issued upon full
compliance to the standards and requirements of HFSRB or CHD-RLED and RITM.

The DOH-LTO of a NAAT-based COVID-19 TL within a DOH-regulated health

facility shall be subsumed in the DOH-LTO
service.
of the
said health facility as an add-on

All the methods being offered by the NAAT-based COVID-19 TL shall be reflected
in the DOH-LTO and recommended for use by the Health Technology Assessment
Council (HTAC).

DOH-licensed COVID-19 TL intends to apply for an additional NAAT platform shall

file an application for additional (add-on) service and shall comply with the
requirements and standards. The following may be an add-on service of a DOH-
licensed COVID-19 TL: rRT-PCR cartridge, rRT-PCR non-cartridge, pooled testing,
use of as specimen, non-PCR based such as isothermal amplification method.

For NAAT-based COVID-19 TL using different rRT-PCR platforms, the proficiency

testing of the higher complexity platform shall be accepted as valid for the other
platforms
(i.e., non-cartridge over cartridge-based).

The COVID-19 TL shall be a separate unit, with its own designated rooms or areas
such as but not limited to receiving room, processing room/s, storage rooms and
clerical/encoding room, appropriate number of staff employed by the laboratory with
the number of samples being processed, as stipulated in Annex A of this Order.

. The NAAT-based COVID-19 TL performing other NAAT methods shall ensure the
adequacy in number of trained personnel dedicated to perform such task, with adequate
space/area for processing and equipment/machine.

The NAAT-based COVID-19 TL shall be headed by a board-certified clinical

pathologist with training in Biosafety, Biosecurity, and Molecular Diagnostic
Principles and Techniques.
phd
7);
 The staff of the NAAT-based COVID-19 TL shall have the minimum appropriate
trainings prescribed by RITM and HFSRB, when applicable.

The NAAT-based COVID-19 TL shall formulate its policies and procedures aligned
with the current DOH guidelines, which shall be strictly enforced and implemented in
the facility. Its Manual of Operations shall include, but not limited to the following:
standard operating procedures; work instructions for each NAAT diagnostic platform;
policies and procedures on biosafety and biosecurity, handling and transporting of
specimens; disposal of infectious wastes; infection prevention and control; records
management; preventive maintenance of the facility and the equipment; and copies of
relevant laws and DOH issuances.

The NAAT-based COVID-19 TL shall only use Philippine Food and Drug
Administration (FDA) authorized in-vitro medical devices (e.g., test kits, reagents and
devices).

. The NAAT-based COVID-19 TL shall be strictly prohibited from outsourcing of

examinations.

All remote collection sites for NAAT-based COVID-19 testing shall apply for a
Certificate of Registration (COR) at the CHD-RLED. The freestanding collection site
shall have a valid MOA with a NAAT-based COVID-19 TL.

. The NAAT-based COVID-19 TL shall:

1. Be part of the COVID-19 Laboratory Network and shall be governed by the
transition plan;
2. Participate in the COVID-19 TL Quality Assurance Program in accordance with
the “Guidelines on the Implementation of the Molecular Laboratory Quality
Assurance Program for the COVID-19 Laboratory Network;” and,
3. Adhere to the current zoning guidelines promulgated by the DOH.

All NAAT-based COVID-19 TL shall adhere to the latest DOH mandated price cap,
and shall make their prices accessible to the public as mandated by the Universal
Health Care Act and related DOH issuances. Ail DOH financial and in-kind subsidy
(.e., supplies, consumables, HRH, operating expenses) shall not be charged and shall
be deducted to the total cost of testing services offered to public.

. The DOH-HFSRB or CHD-RLED shall be notified in writing of any change in

management name, or headship or laboratory personnel. Failure to notify of any
substantial change in the condition of the COVID-19 TL, 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.

The NAAT-based COVID-19 TL shall report the required data elements to the DOH
in accordance with the law and related DOH issuances, such as but not limited to the
following:
1, Republic Act (RA) No. 11332, also known as the “Mandatory Reporting of
Notifiable Diseases and Health Events of Public Health Concern Act.”
2. Administrative Order (AO) No. 2020-0013 issued on April 9, 2020, titled
“Revised Administrative Order No. 2020-0012 “Guidelines for the Inclusion of the
Coronavirus Disease 2019 (COVID-19) in the List of Notifiable Diseases for
Mandatory Reporting to the Department of Health” dated March 17, 2020,” and its
amendments.
ay C4:
 3. Department Memorandum (DM) No. 2020-0542 issued on December 17, 2020,
titled “Interim Guidelines on the Compliance of COVID-19 Testing Laboratories
to Data Submission and Quality Standards.”

S. COVID-19 TL shall follow the standards, criteria and requirements prescribed in the
Annexes of this Order:
1. Annex A — Licensing Standards for NAAT-based specific for rRT-PCR COVID-
19 TL
2. Annex B -
Assessment Tool for Licensing a COVID-19 TL
-
3. Annex C Guideline in Mandatory Notification of Remote Collection Activity of
NAAT-based COVID-19 TL
Annex D - Planning and Design Guidelines for a COVID-19 TL
m Annex E— Checklist for Review of Floor Plans for COVID-19 TL using (E1) Non-
Cartridge-Based and (E2) Cartridge-Based
Annex G — Department Circular No. 2021-0275 titled “Advisory on the Regulation
on Innovations in the RT-PCR Plate Based Diagnostic Platform for COVID-19.”
The COVID-19 TL may use the sample floor plans in Annex Fl and F2 as a
reference.

T. The details as to the additional standards and requirements for new platforms other
than rRT-PCR shall be issued as a DOH
policy as an Annex of this Order.

VI. SPECIFIC GUIDELINES

A. CLASSIFICATION OF COVID-19 TESTING LABORATORIES

1. According to Ownership
a, Government —created by law. A government facility may be under the national
government, DOH, local government unit (LGU), Department of National
Defense (DND), Philippine National Police (PNP), Department of Justice
(DOJ), State Universities and Colleges (SUCs), Government Owned and
Controlled Corporations (GOCCs) and others.
b. Private — owned, established and operated with funds through donation,
principal, investment or other means by any individual, corporation,
association or organization. A private health facility may be a single
proprietorship, partnership, corporation, cooperative, foundation, religious,
non-government organization and others.
2. According
to Institutional Character
a. Institution based — within the premises or the compound of a DOH-regulated
facility. It may be a part of the general clinical laboratory (CL), but with a
specific designated room/s distinct from the CL.
b. Non-institution based
i. located outside the premises or the compound of a DOH-regulated
facility
ii. located within the premises or compound of a DOH-regulated facility
but different owner and independently functioning on its own
3. According to NAAT Service Capability
a. PCR Based (rRT-PCR)
i. Non-cartridge-based — refers to PCR based NAAT requiring separate
workflows for sample pre-treatment (heat or chemical inactivation),
nucleic acid extraction (purified or crudely extracted; automated or
manual) and detection/amplification, such detection systems require
specialized technical knowledge, training, and experience in procedural
execution, quality control, result analysis, and interpretation.
pAd 5 Yi
 ii. Cartridge-based — refers to PCR based NAAT requiring clinical specimen
or nucleic acid as input material, with simplified/compact workflow for
target detection and amplification, usually occurring within the cartridge
or a single compact proprietary detection system, such systems require
knowledge, training, experience in procedural execution, quality control,
results analysis and interpretation.
b. Non-PCR-based (isothermal amplification) — refers to other NAAT which are
recommended for use by the HTAC.

B. LICENSING PROCESS
1. DOH-PTC
a. A duly accomplishedPTC application form (downloadable at
https://hfsrb.doh.gov.ph/) shall be submitted to DOH-HFSRB or CHD-RLED
with its required documents plus the following:
i. Onsite photos; and
ii. Three sets of mechanical plan/s, including isometric or elevation
drawings of
exhaust stack, and computation of room air balance signed
and sealed by a mechanical engineer.
b. The processing of the DOH-PTC application shall be in accordance with AO
No. 2016-0042 titled “Guidelines in the Application for the Department of
Health Permit to Construct (DOH-PTC)” and the Citizen’s Charter.
c. Existing NAAT-based DOH-licensed COVID-19 TL shail submit an updated
floor plan to DOH-HFSRB or CHD-RLED, in
lieu of an approved DOH-PTC.
However, they shall be required to secure a DOH-PTC for
major renovation or
expansion, transfer of location, and change in ownership.
2. DOH-LTO
a.Filing of Application
i. Processing of DOH-LTO from application to issuance shall be
according to the Citizen’s Charter.
ii. Filing of complete application requirements, whether initial, renewal,
or add-on service, shall be at DOH-HFSRB or CHD-RLED, according
to the current DOH guidelines, whether manual or through the Online
Licensing and Regulatory System (OLRS), once it is fully functional:
1) DOH-HFSRB — Medical Facility for Overseas Workers and
Seafarers (MFOWS), Ambulatory Surgical Clinics (ASC) and
Dialysis Clinics with ancillary services, levels 2 and 3 general and
specialty hospitals not yet decentralized based on AO No. 2021-
0019 titled “Guidelines in the Decentralization of Regulation of
Levels 2, 3 General Hospitals and Specialty Hospitals to the
Department of Health Center for Health Development-Regulation,
Licensing and Enforcement Division”.
2) CHD-RLED level 1 hospitals, decentralized levels 2 and 3 general
and specialty hospitals, infirmaries, general clinical laboratories,
and non-institution based COVID-19 TL.
iii. Initial application
1) The facility
shall then submit the notarized completely filled-out
application Form 1 (downloadable at https://hfsrb.doh.gov.ph/)
with its required documents plus the following:
a) Copy of approved DOH-PTC, architectural and mechanical
plans;
b) Notarized list
of personnel; and

iv.
c) Copy of official receipt of payment.
Renewal application a/
74 y 6
 1) The facility shall submit the notarized completely filled-out
application Form 1 (downloadable at https://hfsrb.doh.gov.ph/)
with its required documents plus the following:
a) EQAP certificate of active participation and certificate of
performance with passing result conducted by RITM or
international EQAP providers as approved by DOH; and
b) Proof of payment.
2) The DOH-LTO of the COVID-19 TL shall be cancelled
automatically without notice upon failure to submit a duly
accomplished application form and failure to pay the proper fee
based on the schedule in AO No. 2019-0004 titled “Guidelines on
the Annual Cut-Off Dates for Receipt of Complete Applications for
Regulatory Authorizations Issued by the Department of Health.”
Additional (add-on) Service
1) Duly accomplished application Form 2 (downloadable at
hfsrb.doh.gov.ph) shall be submitted to DOH-HFSRB or CHD-
RLED
for add-on service/s, plus the following documents:
a) List of personnel for the add-on service/s with the
corresponding proof of training based on the current DOH
guidelines;
b) Floor plan layout with equipment layout and process flow;
c) Proof of Payment; and
d) Proficiency testing or Competency Report, as applicable:
i) Proficiency testing for higher complexity platform
(cartridge to add a non-cartridge); OR
ii) Competency assessment report duly signed by the head of
laboratory for non-cartridge-based to add cartridge-based.
iii) For already licensed NAAT-based COVID-19 TL
performing either or both non-cartridge and cartridge-based
tRT-PCR, but will add other NAAT platform, such as
LAMP, the COVID-19 TL will no longer undergo another
round of PT.
2) For already licensed NAAT-based COVID-19 TL and will use
saliva as specimen and conduct pooled testing in the diagnostic
platform, the COVID-19 TL shall not be inspected but shall be
assessed and evaluated based on the submitted documentary
requirements:
a) Proof of training based on the current DOH guidelines, such as
but not limited to training for specimen collection for saliva;
training by the Philippine Society of Pathologists, Inc. (PSP) for
sample pooling strategies; and
b) RITM Certification.
b. Inspection
1 After evaluation of the submitted documents for technical completeness
and correctness, an onsite visit or virtual inspection based on current
DOH
guidelines, shall be arranged to check/validate requirements.
ii. The process for inspection, whether initial, renewal, or add-on service,
shall follow Section VI. E of AO No. 2012-0012 titled “Rules and
Regulations Governing the New Classification of Hospitals and Other
Health Facilities in the Philippines” and the Quality Management
System (QMS) guidelines of the DOH-HFSRB and CHD-RLED.
iti. For already licensed NAAT-based COVID-19 TL performing
cartridge-based rRT-PCR and will add a non-cartridge-based platform
 (ower complexity to higher complexity), the COVID-19 TL shall
comply with the standards and requirements of non-cartridge-based
platform as stipulated on Annex A, Annex B, and Annex D:
1) Personnel with appropriate trainings
2) Equipment
3) Physical plant
iv. For already licensed NAAT-based COVID-19 TL performing non-
cartridge-based platform and will add a cartridge-based platform
(higher complexity to lower complexity), the COVID-19 TL shall
comply with the standards and requirements of non-cartridge-based
platform as stipulated on Annex A, Annex B and Annex D:
1) Personnel with appropriate trainings
2) Equipment
3) Physical Plant
For already licensed NAAT-based COVID-19 TL and will perform
other PCR non-PCR based testing, the COVID-19 TL shall comply
with the standards and requirements to be issued as an Annex/es
Order.
of this

Vi. For already licensed COVID-19 TL and will use saliva as specimen and
conduct pooled testing, they shall be assessed and evaluated based on
the submitted documentary requirements and will not undergo
inspection.
vii. The DOH Inspection Team shall provide the NAAT-based COVID-19
TL with the results of the assessment specifically the identified
deficiencies and shall offer technical and safety recommendations for
correction, as applicable.
viii. The NAAT-based COVID-19 TL shall be given a period to comply
with the deficiencies for a maximum of 30 days. The COVID-19 TL
shall submit evidences as proof of compliance which shall be reviewed
and evaluated by the DOH Inspection Team.
ix. Once the NAAT-based COVID-19 TL has satisfactorily met DOH-
HFSRB’s requirements and standards, the COVID-19 TL shall be
referred to RITM for proficiency testing or its equivalent, if applicable.
c. Proficiency Testing
1, Proficiency testing shall be required for initial application of DOH-
LTO, except for COVID-19 TL applying for and add-on service from
lower to higher complexity platform.
ii. Once the COVID-19 TL passed the proficiency test, RITM shail
endorse the certificate of proficiency to DOH-HFSRB or CHD-RLED.
iii. If a laboratory failed in the first PT panel, corrective measures should
be undertaken before giving the second PT panel.
d. Issuance of DOH-LTO
L The DOH-LTO of a COVID-19 TL shall be recommended for approval
and issuance only after full compliance to the standards and
requirements of DOH-HFSRB or CHD-RLED and upon receipt of
Certificate of Proficiency from RITM.
il. The DOH-LTO shall be signed by the Director IV of DOH-HFSRB or
CHD.
iii. The DOH-LTO shall be valid for one (1) year. Annual renewal of DOH-
LTO COVID-19 TL shall follow the annual cut-off dates as prescribed

pl
by the DOH.

q
8
V
 e. Monitoring
i. The process for monitoring shall follow Section VI. F of AO No. 2012-
0012 and the Quality Management System (QMS) guidelines of the
DOH-HFSRB and CHD-RLED.
ii. The DOH-HFSRB or CHD-RLED may coordinate with RITM for the
conduct of monitoring/unannounced visits to ensure continuous

3.
complianceto the standards.
Certificate of Registration
a. Registration is required for all remote collection sites which shall be renewed
annually to the CHD-RLED.
b. The facility shall then submit the notarized completely filled-out application
Form 1 (downloadable at https://hfsrb.doh.gov.ph/) with its required
documents plus the following:
i. Manual of Operations and technical standards and procedures;
ii. Proof of training as specimen collector;
iii. Copy of a valid MOA with the DOH-licensed COVID-19 TL, if
applicable; and
iv. Proof of payment.
c. All remote collection sites of specimens for NAAT shall follow the latest DOH
prescribed guidelines on swabbing/collection sites.
d. All remote collection activities are required to follow the guidelines stipulated
in Annex C of this Order. The notification shall be made by the DOH-licensed
COVID-19 TL.
4. Fees
a. The fee/s shall follow the schedule of fees currently prescribed by the DOH.
b. The applicant, upon filing the application, shall pay the corresponding fee to
the DOH Cashier or Regional Office Cashier.

VII ROLES AND RESPONSIBILITIES

A. DOH-Health Facilities and Services and Regulatory Bureau (DOH-HFSRB)
shall:
1, Strictly enforce the provisions of this Order and impose appropriate sanctions and
penalties upon violation of any of these guidelines and its related issuances and
laws.
Set standards for the regulation of health facilities including COVID-19 TL.
WPRYN
Inspect and issue DOH-LTO pursuant to the current DOH guidelines.
Create/modify inspection and monitoring tools as the need arises.
Disseminate regulatory policies, standards and forms for information and
guidelines to the DOH-CHDs.
a Provide consultation and technical assistance to relevant stakeholders, including
regulatory officers from the CHD-RLED in the regulation of COVID-19 TL.
Conduct unannounced/monitoring visits to check for continuous compliance of
COVID-19 TL.
Promptly respond to complaints relative to the operation of COVID-19 TL in
accordance with the Citizen’s Charter.
Receive and maintain the records of mandatory notification for remote collection
activities.

B. Research Institute for Tropical Medicine (RTIM) shall:

1. Provide training on Biosafety and Biosecurity and Molecular Diagnostics to
COVID-19 TL staff/personnel, and recognize training providers for such.
2. Evaluate proposed SARS-CoV-2 training curriculum/curricula of applicant third-
party SARS-CoV-2 PCR training providers.
ub ; q
9
 Train/capacitate representatives from HFSRB and/or CHD-RLED on
the conduct
of technical laboratory assessments as part of the COVID-19 Quality Assurance
Program.
Provide assistance to the HFSRB for COVID-19 TL related technical concerns.
Submit recommendations to HFSRB based on:
a. Results of proficiency testing;
b. Laboratory assessment reports;
c. Monthly summary report of key performance and laboratory quality indicators
and quality issues;
d. Laboratory investigation reports; and
e. Other quality-related concerns that may be detected in the course of COVID-
19 Quality Assurance Program implementation.
Ensure the updated list of NAAT kits, nucleic acid extraction kits, and
virus/universal transport media are publicly available via the RITM website.
7. Implement the comprehensive COVID-19 Laboratory Network Quality Assurance
Program.
8. Provide technical assistance within the COVID-19 laboratory network.

. Center for Health Development (CHD)

1. Regulation, Licensing, and Enforcement Division (RLED) shall:
a. Strictly enforce the provisions of this Order and impose appropriate sanctions
and penalties upon violation of any of these guidelines and its related issuances
and laws.
b. Inspect and issue DOH-LTO for hospital based and non-hospital based
COVID-19 TL except those located in ASC, MFOWS and Dialysis Clinics.
c. Conduct unannounced monitoring visits to check for continuous compliance of
COVID-19 TL.
d. Submit the report to DOH-HFSRB on Suspension/Revocation/Cease and
Desist Order (CDO) issued on COVID-19 TL not later than the 15" day of the
following month after the covered quarter.
e. Promptly respond to complaints relative to the operation of COVID-19 TL in
accordance with the Citizen’s Charter.
f. Issue Certificate of Registration and maintain the registry of
freestanding/standalone collection facilities.
CHD COVID-19 Laboratory Network Coordinator shall:
a. Organize and coordinate the referral of specimens within their region pursuant
to the DOH zoning guidelines.

. DOH-Epidemiology Bureau (EB) and its Regional Epidemiology Surveillance

Units (RESU) shall:
1. Receive, maintain, manage, analyze and generate epidemiologic information from
the data submitted by the COVID-19 TL through the COVID-Document
Repository System (CDRS).
Provide training for DOH-licensed COVID-19 TL for encoding and submission of
results to the recognized DOH platform (i.e., CDRS).

. DOH-Knowledge Management and Information Technology Service (KMITS)

shall:
1, Lead the development, implementation, and maintenance of an interoperable and
secure health information system that will synchronize in
real-time all COVID-19
TL data processing and reporting activities, in coordination with HFSRB, RITM,
EB and CHD.

g
f

(10
7
 F. DOH-licensed COVID-19 Testing Laboratory (COVID-19 TL) shall:
1, Continuously comply with the rules and regulations, licensing standards and
requirements for COVID-19 TL, as provided in this Order and DOH related
issuances.
2. Participate in External Quality Assurance Program (EQAP) that may be
administered by RITM or other international EQAP providers approved by the
DOH, surveys and other activities that will be required from them by the DOH.
3. Submit accurate, complete and timely reports and data such as but not limited to,
COVID-19 case data through the COVID-19 Document Repository System
(CDRS) and Laboratory Information System Application Program Interface, daily
Quality Assurance Program Key Performance (KPI) and Laboratory Quality
Indicators (LQI) as required by law and other DOH issuances.
4. Verify the correctness of all entries in the Case Investigation Forms for their
patients/clients.

VIII. PENAL PROVISIONS

A. The NAAT-based COVID-19 TL shall be sanctioned and penalized by the Director of
HFSRB/CHD after thorough investigation, 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 COVID-19 TL, and/or the
persons under their authority:
1. Change in the ownership, location, and head of the laboratory or laboratory
personnel and addition of other NAAT platform without informing the DOH-
HFSRB or CHD-RLED and RITM Quality Assurance (QA) Team.
2. Refusal to allow DOH-HFSRB or CHD-RLED and/or RITM authorized personnel
to conduct inspection or monitoring visits of the COVID-19 TL at any appropriate
time.
3, Non-compliance to the price cap.
4, Non-compliance to mandatory notification of remote collection activity.
5. Issuing false or fraudulent results, knowingly, willfully, or through gross
negligence.
6. Delayed releasing of result (more than 5 days).
7. Non-reporting to RESU and CDRS, and/or to RITM KPI/LQI monitoring (daily
data entry).
8. Non-participation in the RITM annual QAP based on latest DOH issuances and/or
failure of results for two (2) succeeding cycle.
9. Non-compliance to specimen collection guidelines.
10. Non-compliance with licensing or accreditation standards and requirements for
human resource and physical plant.
11. Continued operation even when
technical requirements.
it is non-compliant with regulatory standards and

12. Continued operation despite a Cease-and-Desist Order with respect to the operation
of the facility.

13. Continued operation of a regulated facility without a valid license.

14. Any acts that may compromise:
a. Biosafety and biosecurity of the COVID-19 TL, its staff and the public; and
b. Patient confidentiality.

B. Non-compliance with licensing or accreditation standards and requirements for

equipment shall be considered a violation if deficiencies arenot corrected within thirty
(30) calendar days after receipt of official notice. '
]

Y 11
 C. Any person authorized or licensed to perform 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
NAAT-based COVID-19 TL.

D. The following are the penalties and sanctions that shall be imposed on the NAAT-
based COVID-19 TL upon commission of any
relevant issuances:
ofthe violations in this Order and other

Offense Sanctions and Penalty

1. 1* Offense — Thirty Thousand Pesos (Php 30,000.00)
2. 2% Offense — Fifty thousand pesos (Php 50,000.00)
3. 3% Offense — Revocation of DOH-LTO

E. Any person or entity who operates a NAAT-based COVID-19 TL 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).

F. In case of complaints against the NAAT-based COVID-19 TL, the HFSRB or CHD
Director or his/her authorized representative shall investigate and verify if the NAAT-
based COVID-19 TL concerned, including its personnel, is liable for the alleged
violation or complaint. The HFSRB or CHD may preventively suspend the operations
of the concerned facility for not more than sixty (60) days. Upon completion of the
corrective actions on the findings noted during the investigation or resolution of the
case, the preventive suspension can be lifted immediately and impose the appropriate
penalty and/or sanction:
Offense Sanctions and Penalty
1. 1% Offense — Thirty Thousand Pesos (Php 30,000.00)
2. 2° Offense -— Fifty thousand pesos (Php 50,000.00)
3. 3° Offense — Revocation of DOH-LTO

G. The NAAT-based COVID-19 TL shall discontinue the provision of its services until
such time that all violations have been corrected and sanctions have been imposed and
complied with.

H. A NAAT-based COVID-19 TL with revoked license can only re-apply after one year
from the date of DOH-LTO revocation.

IX. APPEAL

Any COVID-19 TL or any of its personnel not amenable with the decision of the DOH-
HFSRB/CHD-RLED may file a notice of appeal to the Head of the Health Regulation Team
(HRT) within ten (10) days after the receipt of notice of decision. All pertinent documents
and records of the appellant shall then be elevated by DOH-HFSRB/CHD-RLED
HRT. The decision of the Head of the HRT,
if
to the
still contested may be brought on final
appeal to
the Secretary of Health, whose decision shall be final and executory.

REPEALING CLAUSE

rules and regulations shall rescind AO No. 2020-0014 titled, “Guidelines in Securing
These
a License to Operate a COVID-19 Testing Laboratory in the Philippines,” and its
amendments, all AO and previous issuances inconsistent thereof. /y

4 y
12
 SEPARABILITY CLAUSE

In the event that any provision or part of this Order be declared unauthorized or
rendered invalid by any court of law or competent authority, provisions not affected by
such declaration shall remain valid and effective.

XII. EFFECTIVITY

of general circulation and upon filing three

its
This Order shall take effect fifteen (15) days following publication in a newspaper
(3) copies to the University of the
Philippines Law Center.

MARIA ROSARIO S. VERGEIRE, MD, MPH,

Officer-In-Charge
CESO
II
Department of Health
 A.O. No. 2622 -
ANNEX A
-0004
Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

LICENSING STANDARDS FOR NUCLEIC ACID AMPLIFICATION TEST-BASED

SPECIFIC FOR REAL TIME REVERSE TRANSCRIPTASE-POLYMERASE CHAIN
REACTION COVID-19 TESTING LABORATORIES

Real Time Reverse Transcriptase-Polymerase Chain Reaction (rRT-PCR) refers to a PCR method
where RNA molecules are converted to their complementary DNA sequences through reverse
transcriptase enzyme and followed by amplification of the synthesized complementary DNA.

I. PHYSICAL FACILITIES

1023
Every COVID-19 TL shall have an adequate and appropriate areas to safely, effectively and
to
efficiently provide the services clients.

A. The COVID-19 TL shall conform to all applicable local and national regulations for the
construction, renovation, maintenance and repair of COVID-19 TL (i.e., Republic Act (RA)
No. 6541, RA No. 9514, Administrative Order (AO) No. 2016-0042.).

B. The COVID-19 TL shall have a dedicated space for each of the following:
1. For non-cartridge based rRT-PCR
a, Clean WriteShop (outside or main lab)
i. Receiving of document
ii. Encoding of Data
iii. Encoding of Results
b. Specimen Reception
c. Pre-Analysis
i. Specimen Receiving (unboxing)
ii. Specimen Handling
iti. Sample Preparation Virus inactivation
iv. Nucleic acid extraction (Pre-PCR)
v. Template Adding
d. Reagent Preparation
@ PCR
f. Support Area
i, Pathologist Area
ii, Supply Area
iii. Waste Holding Area
iv. Other facilities for personnel use
1) Toilet with lavatory
2) Pantry/lounge
g. Specimen Collection for laboratories conducting swab collection
2. For cartridge-based rRT-PCR
a. Clean WriteShop (outside or main lab)
i. Receiving of document
ii, Encoding of data
iii. Encoding of results
b. Specimen Reception
 c. Pre-Analysis/Analysis
i. Specimen Receiving (unboxing)
ii. Specimen Handling
iii, PCR
d. Support Area
i, Pathologist Area
ii. Supply Area
iii. Waste Holding Area
iv. Other facilities for personnel use
1) Toilet with lavatory
2) Pantry/lounge
e. Specimen Collection (Swabbing)

C. Unidirectional workflow following the above-mentioned activities shall be monitored and

maintained at
all times for the following: staff, specimen, reagents and wastes.

D. The COVID-19 TL shall conform to the required space for the conduct of its activities,
personnel, fixtures, equipment, sink, etc. shall also be considered. Minimum space
requirements for each are
listed in Annex D.

E. The COVID-19 TL shall have controlled and adequate ventilation with the prescribed air
changes per hour maintained for each specific area as listed in Annex D.

F. The COVID-19 TL shall have periodic calibration, preventive maintenance, and

certification shall be required for heating, ventilation, and air conditioning (HVAC)
equipment and machine and shail be duly documented.

G. The COVID-19 TL shall have adequate lighting, clean, safe and functional areas based on
the services provided.

H. The COVID-19 TL shall have program of proper maintenance and monitoring of physical
plant and facilities.

Il. PERSONNEL
Every COVID-19 TL shall have an adequate number of qualified, trained and competent staff,
depending on the workload, to
ensure safe, efficient and effective delivery of quality services.

A. Head of the COVID-19 TL (HOL)

1. The HOL shall be a competent and experienced clinical pathologist, with specialized
skill set related to molecular or related diagnostic platforms. The HOL
is essentially
responsible for the operation of the entire COVID-19 TL, its personnel, functions, and
data, all of which shall meet the quality assurance criteria and regulatory requirements
stipulated in ANNEX B Assessment Tool for Licensing COVID-19 TL.
2. The HOL shall oversee the operation and have administrative and technical supervision
of the activities in the COVID-19 TL.
3. The HOL shall supervise the staff in accordance with thestandards set by the Philippine
Society of Pathologists (PSP).

LT ¥ 2
 4. The HOL shall visit once a month with at least twice a week of supervisory calls and/or
videoconferencing OR at least once a week physical visit. The visits shall have to be
well documented and recorded.

. Registered Medical Technologist (RMT)

1. The RMTs shall be adequate in number as stipulated in Annex B Assessment Tool for
Licensing a COVID-19 TL and required to be full-time to conduct the laboratory
procedures. An increase in workload shall require a corresponding increase in the
number of personnel.
There shall be a biosafety and biosecurity officer, who may be designated by the HOL,
in-charge primarily of the risk assessment of the COVID-19 TL and implementation of
infection and prevention and control (IPC) standards program.

. Other Analysts
1. allied health professionals with a bachelor’s degree relevant to the job, and with
Any
knowledge, experience, and skills in molecular biology techniques, such as Molecular
Biology and Biotechnology, Biology, Applied Biology, Biochemistry, and
Microbiology shall be allowed to perform tests/activities in the COVID-19 TL as
Analysts.

. Support Staff
1. Support staff such as, but not limited to adequate number of laboratory aide,
receptionists, and encoder shall be required from a COVID-19 TL.

. Trainings
1, All staff and analysts shall be trained in Fundamentals of Biosafety and Biosecurity,
which shall cover Biological Risk Assessment, Mitigation Controls (engineering,
practices and procedures, administrative), Personal Protective Equipment, specimen
transport, waste management, decontamination and disposal, and Emergency Responses
(biological spill drill). The abovementioned trainings, which can be provided in-house,
shall be required for laboratory aide, receptionist and encoder.
Molecular Diagnosis or Molecular Laboratory Diagnostics for Clinical Pathologist and
Analysts.
. The staff of the COVID-19 TL shall be proficient on Molecular Diagnostic Techniques
with proof of competency from RITM or RITM recognized training providers.
The staff (encoder) should undergo training on the COVID-19 Information System -
COVID-19 Document Repository System (CDRS) as provided by the Epidemiology
Bureau - COVID-19 Surveillance and Quick Action Unit and should possess the
certification showing completion of training.

. The staff shall undergofit

testing for respirator with at least 95% efficiency e.g. N95 mask.
The COVID-19 TL may purchase Respirator Fit Testing kit, provided that a RITM trained
staff of the COVID-19 TL will conduct the fit testing.

. The staff shall have an annual medical examination including appropriate vaccination.

pf
. All staff shall have daily medical monitoring for any sign or symptom.
 I. The staff shall have continuing updated trainings on biosafety and biosecurity, new
techniques and technologies, among others.

Ti. EQUIPMENT/INSTRUMENTS/REAGENTS/SUPPLIES
Every COVID-19 TL shall have an adequate equipment, instruments, reagents, and supplies
which are
all in good working condition and sufficient for the operations.

A. The COVID-19 TL shall have available and operational equipment and instruments
appropriate and consistent to the designated areas.

The COVID-19 TL shall have a calibration, preventive maintenance and repair program for
every equipment/machines/instrument including the biosafety cabinet/s on a regular basis.
These shouldbe carried out and duly documented.

The COVID-19 TL shall have an adequate and available reagents and supplies for the
conduct of test/s with proper handling and storage at
their required conditions/temperatures.

The COVID-19 TL shall have a documented inventory of equipment, supplies, reagents and
control.

Refer to Part III of Assessment Tool for Licensing a COVID-19 TL for the List of
Equipment.

The COVID-19 TL shall have a contingency plan in case of

equipment/machines/instrument breakdown and malfunction, natural disaster/calamity,
laboratory contamination, limited personnel due to increasing infection rate and the like,
shall not accept specimens from any patient or
referral health facility. The COVID-19 TL
shall have a notarized MOA with another DOH licensed COVID-19 TL. The COVID-19
TL shall inform their clients and refer them to another DOH licensed COVID-19 TL.

The COVID-19 TL shall inform in writing the DOH-HFSRB or CHD-RLED and the
Epidemiology Bureau — COVID-19 Surveillance and Quick Action Unit about the
temporary suspension of their COVID-19 TL. Full operation of the COVID-19 TL shall be
restored within 30 days. However, if
the laboratory still needs more time, they shall inform
the DOH-HFSB or CHD-RLED
and facility needs to re-apply.
in
writing. Failure to do so, DOH-LTO may be
revoked,

. Referral of samples shall be coordinated with the CHD-COVID-19 Laboratory network

coordinator in accordance with Department Memorandum (DM) No. 2020-0188 "Interim
Guidelines on the Zoning of COVID-19 Laboratories.

IV. SERVICE CAPABILITY

Every COVID-19 TL
shall ensure quality and safe services to clients, to its personnel and to the
general public.

A. The COVID-19 TL shall comply with the licensing standards in Annex B Assessment Tool
for Licensing a COVID-19 TL and other relevant issuances.
4
y
 B. The COVID-19 TL shall be allowed to perform testing using innovations in the diagnostic
platform which are approved and recommended by the Health Technology Assessment
Council (HTAC). It
shall be an add-on service of the DOH-licensed COVID-19 TL.

C. For pooled testing and saliva as specimen as Stipulated in Annex G shall be

strictly
followed.

D. For remote collection, refer to Annex C. Guidelines in Securing a Remote Collection

Permit.

V. QUALITY IMPROVEMENT ACTIVITIES

Every COVID-19 TL
shall establish and maintain a system for continuous quality improvement
activities.

A. There shall be a regular performance of Internal Quality Assurance Program which will
includes:
1. Internal Quality Control Program for technical procedures.
2. Internal Quality Assurance Program for inputs, processes and outputs.
3. Continuous Quality Improvement Program covering all aspects of laboratory
performance which include identification of the many potential risks in the laboratory
processes and document the recommendations to mitigate the risks, and monitor
occurrences at least annually. This also includes analysis of the client
feedback/customer satisfaction survey.
4. Periodic Risk Management Plan.
5. Monitoring of repeats and positivity rate.

B. The COVID-19 TL shall

participate and pass in the External Quality Assessment Program
(EQAP) in
accordance with Department Memorandum No. 2021-0332, given by RITM or
other DOH recognized local and international EQA providers.

C. Evidence of Participation in the Laboratory Network QA Programme:

1. EQA certificate of participation
and records of root cause analysis and troubleshooting
done by laboratory management if the EQA results are less than 100%. EQA
participation may include additional events from international bodies such as WHO,
RCPA, CAP as applicable.
Daily Key Performance Indicators and Laboratory Quality Indicators (KPI-LQI]) data
entry (ie. Lab dashboard for KPI/LQI showing daily submission of data or the
acknowledgement email for KPI/LQI data submission).
Results of Laboratory Assessment (if the lab is included in the priority list for
assessment); copy of the report from RITM QA Team, records of actions done to
address findings and/or recommendations for quality improvement (accomplished Root
Cause Analysis - Corrective Action Plan form).
4, Other evidence/s of Quality Assurance activities, such as but not limited to:
a. Records of Performance of
quality control and validation,
b. Records of Competency assessments, training, learning and development
interventions of staff,

pl
c. Records of Internal quality assessments
q 5
 d. Monitoring of supplies, reagents as to optimal storage, expiration, and usage
e. Records of preventive maintenance, repairs, calibration of equipment
f. Records of continuous quality improvement activities based on customer feedback,
IQA assessments, audit findings.

VI. INFORMATION MANAGEMENT

Every COVID-19 TL shall maintain a system of communication, recording, reporting and
releasing of the patient’s results, in adherence to Republic Act (RA) No. 10173 also known
the “Data Privacy Act of 2012” AND RA No. 11332 also known as the “Mandatory Reporting
as
of Notifiable Diseases and Health Events of Public Health Concern Act.”

A. Administrative and technical policies and procedures

1. The COVID-19 TL shall have written policies and procedures for the provision of
laboratory services, the operation and maintenance of the laboratory and shall include
accountabilities of every personnel working in the laboratory, and material
accountability and traceability.
The COVID-19 TL shall have documented technical procedures for services provided
which will ensure quality of laboratory results.
The COVID-19 TL shall have policy guidelines on biosafety and biosecurity which shall
also include risk assessment.
a. Biosafety manual (institution specific/pathogen and procedure specific)
b. Procedure for selection, use, PPE donning and doffing
c. Specimen shipping and transport
d. Specimen retention and disposal
e. Decontamination of work surfaces
f. Biological spill response
The COVID-19 TL shall have procedures for receipt and performance of requests.
The COVID-19 TL shall have procedures for the reporting of workload, quality control,
inventory control, work schedule and assignments.
The COVID-19 TL shall have procedures for the reporting and analysis of incidents,
adverse events, and in handling complaints.
The COVID-19 TL operating hours shall be known to its clients.
The COVID-19 TL shall post the price of its services in a conspicuous place.
of
soem

Manual Procedures and Work Instructions on the laboratory techniques.

. Standard Operating Procedures of the facility, which shall include, but not limited to,
policies on Biosafety and Biosecurity; proper use of Personal Protective Equipment;
Specimen Storage, Transport and Disposal; Waste Management; Emergency Response
System (accidents, medical emergencies, spills, natural disasters, facility containment).
11. Policies and procedures on specimen received from outside the facility (swab collectors)
and remote collection sites (collection facilities/satellite facilities).
12. Accomplished World Health Organization (WHO) Risk Assessment form.
13, A copy (soft or hard copy) of RITM BioRisk Management Office Interim Biosafety
Guidelines for Laboratories Handling and Testing SARS-COV-2 (COVID-19)
Specimen Version 2 or itslatest version.
14. Policy on Management Review and Internal Quality Audit and findings which shall be
presented to the management.
15. Policy on laboratory verification of registered/validated/authorized reagents and

pf
supplies.

| 6
B. Laboratory Report
1. The COVID-19 TL shall release results in accordance with DOH guidelines.
2. The COVID-19 TL shall release approved reports that bear the name, PRC registration
number, and original or digital signature of the registered medical technologist (s) who
performed the laboratory examinations, and the pathologist who shall be accountable
for the reliability of the results. The report shall also include the principle of the test
performed (e.g. non-cartridge based or cartridge-based rRT-PCR).
The COVID-19 TL shall have a policy guideline on the use of digital signature, if
applicable. The use of digital signature for laboratory results shall be permitted only if
properly authenticated by the Department of Information and Communication-
Philippine National Public Key Infrastructure. The use of digital signature shall also be
in accordance with the provisions of the E-Commerce Law.
All Positive and Negative linelist must be uploaded to the CDRS following the
prescribed format of the Epidemiology Bureau.
Completely accomplished Case Investigation Forms (CIF) and linelist of positive and
negative results shall be immediately encoded to the digital platform recommended by
the DOH, such as but not limited to, CDRS etc.
The COVID-19 TL shall include a quick response (QR) code and/or barcode for
verification system.
A standard information technology system shall be adopted, once available, that will
seamlessly synchronize all COVID-19 TL data reporting activities.
The COVID-19 TL shall have an information system capable of connecting with the
CDRS through an API or, in the absence of said information system, should have
adequate number of personnel to encode, scan, and upload documents to CDRS.
The COVID -19 TL shall adhere to the following reporting requirements:
a. Mandatory zero reporting (reporting of no tests done if no tests were done,
otherwise reporting of results) on a daily basis;
b. Submission of results and data to the DOH-Epidemiology Bureau - COVID-19
Surveillance and Quick Action Unit (DOH-EB-CSQAU); and,
c. Submission of results to the Regional and Local Epidemiology and Surveillance
Units covering the address of the laboratory and the current address of the case.

C. Laboratory Records
1. The COVID-19 TL shall maintain and ensure the confidentiality of all records in
accordance with the RA No. 10173 or Data Privacy Act of 2012. All records shall be
keptin a secure area, protected from theft, tampering and damage.
The COVID-19 TL shall maintain complete records of all laboratory activities done
from laboratory requests, sampling records, analytical reports, to quality control
records.
The COVID-19 TL shall maintain personnel records, equipment maintenance records,
computer programs and electronic data.
wP
The COVID-19 TL records shall be kept and organized for easy retrieval
The COVID-19 TL shall have protocol on the retention of laboratory documents,
records and specimens in accordance with the standards promulgated by the DOH
and/or by competent authorities for such purposes.
The COVID-19 TL shall have logbook or digital record for:
a. Receiving of specimen with laboratory request from the health facility or attending
physician.
b. Specimen storage, transport, and disposal.

} 7
 c. Reporting and submission of results to the DOH-EB-CSQAU and DOH Regional
Epidemiologic and Surveillance Unit.
d. Sentinel/adverse events.
e. Preventive and corrective maintenance of equipment and instruments.
f. Maintenance and monitoring of health facility.
7, The COVID-19 TL shall have
a written plan on the maintenance and transfer of records
in the event of change in ownership or termination of operation.

VII. ENVIRONMENTAL MANAGEMENT

Every COVID-19 TL shail ensure that the environment is safe forits patients and staff, including
the general public.

A. The COVID-19 TL shall have a written plan and program of proper disinfection and
preventive maintenance of
the facility.

B. The COVID-19 TL shall have appropriate signage, and that only authorized personnel shall
be allowed entry.

C. The COVID-19 TL shall strictly observe the use of Personal Protective Equipment and
adherence to
infection control Policies.

D. The COVID-19 TL shall have procedures for the proper disposal of infectious wastes and
toxic and hazardous substances in accordance with R.A. No. 6969 known as “Toxic and
Hazardous Substances and Nuclear Wastes Act” and other related policy guidelines and/or
issuance (e.g. DOH Healthcare Waste Management Manual).

E. The COVID-19 TL shall have a Memorandum of Agreement (MOA)/Memorandum of

Understanding (MUA) with infectious waste and toxic and hazardous substances hauler or
EMB certificate, as applicable.

“Md 7]
 A.O. No. 2023 - 0004
Republic of the Philippines ANNEX B
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

ASSESSMENT TOOL FOR LICENSING A COVID-19 TESTING LABORATORY

INSTRUCTIONS:
1. To properly fill-out this tool, the Licensing Officer shall make use of: INTERVIEWS, REVIEW OF
DOCUMENTS, OBSERVATIONS and
VALIDATION findings.of
2. If the corresponding items are present, available or adequate, place a (WV) on
each of the appropriate spaces under
the COMPLIED column or space provided alongside each corresponding item. If not, put an (X) instead.
3. The REMARKS column shall document relevant observations. If the space is not enough, may a clean separate use
sheet indicating the specific section in the assessment tool.
4. Make sure to fill-in the bianks with the needed information. Do not leave any items blank.
5. The Team Leader shall ensure that all team members shall accomplish all of the following at the last page of the
tool:
a. Write down their names and designation in printed format;
b. Affix their signatures;
c. Indicate the date of inspection/monitoring; and,
d. Ensure the completeness of the tool.
6. The Team Leader shall make sure that the Head of the
facility, or when not available, the next most senior or
responsible officer, likewise, affix his/her signature on the same aforementioned pages, to signify that the
inspection/monitoring results were discussed during the exit conference and a duplicate copy also received.

PART
I. GENERAL INFORMATION
Name of Facility
Complete Address
Number & Street Barangay/District

Municipality/City Province/Region

Contact Information E-mail Address

Initial { ] Renewal { ] Monitoring [ ]

Existing License No. Date Issued: Expiry Date:

Name of Owner or Governing

Body
(if corporation)
Name of Head of Laboratory

Classification According to:

Ownership: O Government Ol Private

Institutional-Character: O Institution-based O Non-institution-based

NAAT Service Capability rRT-PCR

O Other
HTAC
NAAT
as recommended by

rRT-PCR
O Non-cartridge Based O Both
O Cartridge-based

nd 4
DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
01/20/2023
Page 1 of 24
 PART
II. ASSESSMENT TOOL

il ‘Clearly structured ‘Observe

organizational chart @ Organizational Structure / Chart is
posted/displayed in conspicuous
area
e@
Updated organizational chart
indicating the names with latest
pictures (at least passport size) and
designation, reflecting lines of
authority, accountability,
communication, interrelationship,
hierarchy of functions and flow of
referrals.
. Mission, vision and Document Review
objectives shall be in e Written vision, mission, and
accordance with objectives
Republic Act (RA)
4688 Observe
e Vision, mission, and objectives
displayed in a conspicuous area
visible to clients
. DOH-License-to- Document Review
Operate (LTO) and © Compiled COVID-19 Testing
other pertinent Laboratory (TL) Administrative
documents Order and reports of
inspection/monitoring

Observe
e@
Valid DOH-LTO posted in a
conspicuous area visible to clients
. Administrative and Document Review
technical monitoring © Supporting documents for
and evaluation evaluation and monitoring of
activities to assess activities such as records, logbooks,
management and checklist of supplies, inspection
organizational report, purchasing or procurement
performance and acceptance of supplies, etc.
. Policy on Document Review
Management Review e Written policy on management
review
© Compiled minutes of meeting
(reflecting the date, time,
attendance, agenda and action taken
signed and approved by head of
laboratory), held at least twice a
year or as needed
. Procedures for Document Review
handling complaints e Written protocol/s for handling
and client feedback
complaints/ client feedback.
e Forms for complaints/ client
feedback
e Records of —complaints/client

/
feedback and actions taken
el
]
DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
24
BOIEE
2032
Ip
 © Documented analysis of the client
feedback/customer satisfaction
survey

Observe
© Suggestion box visible to clients

a Policy on continuing Document Review

program for staff @ Written policies and procedures for
development and staff development and training
training
e Proof of training through relevant
certificates, memos, written
reports, budgetary allocations
© Workload evaluation for human
resource of COVID-19 laboratory
operation

Interview
@ Human Resources Management
Officer/Administrative Personnel
Officer/RMT Supervisor/Training
Officer
Policy for hiring, Document Review
orientation and e@
Written policies and procedures on
promotion for all hiring, orientation and promotion of
levels of personnel
personnel at all levels
Policy for discipline, Document Review
suspension, demotion © Written policies and procedures on
and termination of discipline, suspension, demotion
personnel at all levels and termination of personnel at
all
levels

10. Clearly defined duties Document Review

and responsibilities © Written job description or duties
and responsibilities of all
laboratory personnel
11. Adequate number of Document Review
qualified personnel © of personnel with designation
List
with documented
e Area of assignments indicated in
training and
the posted work schedule signed
experience to conduct and head of
approved by
the laboratory
laboratory.
procedures performed
e Proof of attendance
. There is
policy on the Document Review
implementation of
National Database of
e Proof of submission
NDHRHIS
of data to

Human Resource for

Health Information
System (NDHRIS)
13. Overall supervision of Document Review
the head of the © Proof of once a month visit with at
-
COVID-19
testing least.weekly supervisory calls
laboratory (TL) on and/or _videoconferencing OR at

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
puedes 24
Ol :
 technical procedures least once a week physical visit,
as well as on the documented either through
administrative biometrics attendance or logbook,
laboratory call time log and the like
management e Notarized list of handled COVID-
19 TL including the addresses
14. Procedures and Document Review
policies for medical @ Daily health monitoring forms
surveillance
e Documented guidelines and records
of daily health monitoring of all
COVID-19 staff
15. Each personnel shall Document Review
have a record of
updated 201 files
© Proof of qualifications
a. Head of the Document Review
Laboratory (HOL) e@
Updated Resume/Personnel Data
Sheet
Valid PRC ID and Certificate
PSP Board Certificate
Training Certificates:
© Biosafety Training specific for
COVID-19
© Molecular Laboratory
Diagnosis
© Notarized Employment Contract or
Appointment Letter (as applicable)
e Annual Health Status (Latest
Medical Certificate)
@
Vaccination record (Influenza and
COVID-19)
Additional requirement for cartridge-
based
e Training certificate specific for
Cartridge-Based Technology (eg.
GeneXpert System)
b. Analysts Document Review
e@
Updated Resume/ Personnel Data
Sheet
Valid PRC ID and Certificate
e Training Certificates:
* Molecular Laboratory
Diagnosis
+
Biosafety Training specific for
COVID-19
e@
Notarized Employment Contract or
Appointment Letter (as applicable)
e Annual Health Status (Latest
Medical Certificate)
e Vaccination record (Influenza and
COVID-19)
e Respirator Fit Test Record
Additional requirement as
applicable:
e Training certificate specific for
Cartridge-Based Technology (eg.
GeneXpert System)

of 1 DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
20/2023
2
2
 Machine specific training as
provided by the distributor and/or
manufacturer
Training from PSP for sample
pooling strategies
c. Support Staff Document Review
i. Laboratory Resume/ Personnel Data Sheet
Aide
Training Certificates:
ii. Encoder
iii. Receptionist
+ Biosafety specific for
iv. Others, as COVID-19 (may be in-
applicable house)
« COVID-19 Information
System - COVID-19
Document Repository
System (CDRS), or its
equivalent, for encoder/s
Notarized Employment Contract
Annual Health Status (Latest
Medical Certificate)
Vaccination record (Influenza and
COVID-19)
d. Biosafety and Document Review
Biosecurity Officer, Proof of designation i.e.,
may
be designated appointment letter with duties and
by the HOL responsibilities signed and
acknowledged by thestaff
Copy of daily biosafety
compliance checklist
Certificate of training in Biosafety
and Biosecurity from RITM or its
authorized provider

Specific Human Resource Requirements specific for rRT-PCR classification

Human Resource Non cartridge Cartridge
Three (3) Analysts @ One (1) RMT
per two (2) machines
« Three (3) Registered Medical
Technologist (RMT), OR
+ Two (2) RMT and any allied health
professionals with a bachelor’s
Analyst per-8-hour shift degree relevant to
the job, and with
knowledge, experience, and skills in
molecular biology techniques, such
as Molecular Biology and
Biotechnology, Biology, Applied
Biology, Biochemistry, and
Microbiology
e (1) Laboratory aide e@
(1) Laboratory aide four (4) machines
Support Staff per 8-
hour shift
@ [ aansamples
(1) Encoder/200 :
© (1) Encoder
i Or.
per four (4) machines
e (1) Receptionist
Reliever e (1) Analyst © (1) Analyst
NOTE:
1, An increase in workload shall require a corresponding increase in the number of personnel (80-100 tests/spifD)

)
DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
01 20 2032
20}

Page 5 of 2:
 irec

—
16. Adequate and Document Review
appropriate areas to Approved copy of DOH-PTC,
safely, effectively and floor plans and mechanical plans,
efficiently provide the checklist for review of floor plan
to
services clients
Documented smoke pattern test
(indicator of airflow)
Documented magnehelic gauge
measurement including the
monitoring forms used
Documented measurement of
actual air changes per hour
(ACH) ofeach room
Air balancing report bearing the
minimum information of the
following:
+ Room Name
+ Room Pressurization
«+
Room Volume
« Supply Air (CFM) Reading
« Exhaust Air (CFM) Reading
+ Air Changes/Hour (ACH)
« Differential Pressure Reading

Observe
Unidirectional workflow is being
followed
¢ Workflow and equipment
placement followed the clean
to dirty principle
+ Specimen flow
«Personnel flow
+ Waste flow
Lighting fixtures are surface
mounted with cover
Approved floor plan was
followed
Availability of a monitoring
device or other means to verify
all the negative pressure rooms
All doors are self-closing,
lockable and with vision panel
All finishes, floors, walls, ceiling
work counters and furniture were
made of monolithic, impervious
or water-tight, anti-bacterial,
chemical resistant and easy to
clean material:
¢ Floor
+ All corners or edges are
coved
All room gaps or opening were
sealed.
Ceiling height is at least 2.6
meters and can accommodate
DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
O40’
Page 6 off24
=
CRITERIA INDICATOR / EVIDENCE COMPLIED REMARKS
biosafety cabinets and PCR hood
or laminar flow hood.
e Presence of eyewash in the
sample receiving room and
sample preparation room or the in
common doffing room.
e@
Approved Mechanical plan is
followed:
+ Exhaust Air Grille Locations
are on the dirty side of the
laboratory preferably on top
of the biosafety cabinets.
+ Supply Air Grille Locations
are on the clean side of the
laboratory preferably near the
entrance doors.
« All conditioning units
air
were split
type, air directions
were away from the biosafety
cabinets and PCR Hood or
Laminar Flow Hood.
« Exhaust stack has no
gooseneck, cap, cover or
elbow and at least 3 meters
above the highest point of the
roof or 3 meters above the
highest point of the roof of
the
adjacent building and distant
to other taller structures with
open windows above
the above criteria were not met, additional
’k If

exhaust requirement must be installed (e.g.,

Bag-in Bag-out (BIBO) HEPA Filter Box) and
should pass HEPA filter integrity test
+ Supply intake location was
least 25 ft. away from the
at
exhaust stack and in opposite
direction.
e Balanced according to the
minimum pressurization
requirement per room:
+ 12 ACH for sample receiving
room and for sample
preparation room
« 6 ACH for PCR room
+ Slightly negative, lower than
PCR room or neutral pressure,
for template adding room
+ Positive pressure for reagent
preparation room
e Passed smoke pattern tests per
room including all
the pass boxes
© Dedicated space for each of the
following activities:
+ Clean Write Shop (outside or
main lab)
+ Pre-Analysis
+ Reagent Preparation.

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
01
Page 7
20/292:
of
_~
 CRITERIA INDICATOR / EVIDENCE COMPLIED REMARKS

« Template Adding
« PCR
« Support Area
* Specimen Collection
(Swabbing)
* Template adding not required for
cartridge based rRT-PCR
17. Program of proper Document Review
maintenance and Written policy and program for
monitoring of physical the proper maintenance and
plant and facilities monitoring of physical plant and
facilities
Proposed schedule for preventive
maintenance
e Documented records and reports
on compliance to biosafety
cabinet standards and_ other
safety practices

Observe
@ Updated proof of actual
implementation of maintenance
as to. structure, ventilation,
lighting & water supply
e Adequate lighting shall be
provided in all areas
18. Procedures for the Document Review
proper waste Written policy on disposal of
management including wastes that conform with
handling and disposal Healthcare Waste Management
of waste and hazardous/ Manual, and RA No. 6969
infectious substances
Written protocols on waste
that shall conform to
decontamination and disposal,
set
the standards by the
including validation and use of
DOH
indicators for autoclave
Records of conducted waste
decontamination using the
autoclave’s indicator (i.e.,
biological)
Notarized Memorandum of.
Agreement (MOA) with DENR
accredited hauler/ EMB
Certificate, as applicable (no
hauler) for infectious waste,
toxic, and hazardous substances

Observe
Proof of proper management of
wastes from point of generation,
segregation (color-coded waste
bins), disinfection, up to the final
disposal
Provision of storage for
hazardous waste
IV. EQUIPMENT/INSTRUMENTS
There shall be adequat ‘e equipment which are all in good worki ing condition.
19, Adequate number of Document Review
operational equipment
DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
01/ 20.2933
Page 8 off24
 CRITERIA
to provide the
laboratory
e
INDICATOR
/ EVIDENCE

List of available and functional

equipment in
the laboratory
COMPLIED REMARKS

examinations that the

—
e@
Written protocols on laboratory
laboratory is licensed
for
biosafety and biosecurity on the
operation and maintenance of
biosafety cabinet and autoclave

Observe
e Fully functional and operational
equipment
20. Program for Document Review
calibration, preventive e Records of regular schedule
maintenance and including the frequency of
repair for the preventive maintenance and
equipment calibration
© Updated certificate of calibration
and maintenance of equipment
© Record of corrective repair
maintenance with service reports
or logbooks
e Laminar flow hood or PCR hood
and BSC certification report
reflecting the following
parameters:
* Methodology
+ Standards used for
each test
¢ Equipment calibration
« Results of the following
parameters:
- Inflow velocity test
- Down flow average and
uniform velocity test
- High efficiency
particulate air (HEPA)
filter integrity test (supply
and exhaust filters)
- Smoke pattern test (4
tests: work access
opening, view screen
retention, work area, sash
window seal)
- Site assessment test:
(alarms, BSC location,
exhausts connection)
+ Results pass or fail

Observe
e@
Presences of validated
certification or calibration
certificate for all equipment
e Interlocking doors of pass box
and follows the minimum
dimensions
21. Contingency plan in Document Review
case of equipment e Written policy on contingency
breakdown plan in
case of equipment
breakdown

DOH-HFSRB-QOP01-Covid19TL-AT

Page 9 o'
 CRITERIA
©
INDICATOR

Copy of MOA
/
with
EVIDENCE

other DOH
Licensed COVID-19 TL, if
COMPLIED REMARKS

applicable
V. REAGENTS AND SUPPLIES
There shall be adequate reagents and supplies which are in good condition and sufficient enough for the operations.
22. Adequate stock of Document Review
properly stored and © Quality records of supplies and
inventoried reagents reagents with expiration date,
and supplies for the including —_usage/consumption

Sea
laboratory and disposal
© Certificate of Product
Pee -
Registration from Food and Drug
provided Seite (FDA)
Administration

Observe
e
Availability and complete
reagents and supplies
© Validate the expiration dates of
reagents
23. Adequate storage Document Review
facilities/area for the e Temperature monitoring records
reagents and supplies as follows:
which should be stored
R Room temperature reading
A

«
under their such as
:

.
freezer
refrigerators for * Refrigerator and
temperature reading
perishable reagents
and supplies
Observe
e Availability of appropriate
thermometer
@ Monitoring of the room
temperature
e Temperature of refrigerators and
freezers
24. Appropriate storage Document Review
facilities/ area and © Material Safety Data Sheet
technique for (MSDS) available for all
flammable, reagents/supplies and accessible
combustible and to all personnel at all times
hazardous
chemical/reagents Observe
e Organized per section with
National Fire Protection
Association (NFPA) Label
VI. ADMINISTRATIVE POLICIES AND PROCEDURES
Policies and procedures for provision of laboratory services are formulated for the operation and maintenance of the laboratory.
25. Administrative Document Review
policies & procedures e Written policies, protocols, and
for provision of procedures signed and approved
laboratory services and by the head of laboratory
for the operation and © Written guidelines in the
maintenance of the operation and maintenanceof the
laboratory
laboratory including policy on
security of supplies, specimens
and confidentiality of records,
and material accountability and
traceability
ad DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
01
Page 10
2 of
2g22

24
00
 CRITERIA INDICATOR / EVIDENCE COMPLIED

e Written policies on Good

Laboratory Practice (GLP)
© Documented records of actual
inventories of personal protective
equipment, including respirator
model, size, and brand and must
match to all fit tested analysts
@ Written policies on washing and
use of scrub suits and lab gowns
in the laboratory

Observe
e GLP including the use of
personal protective equipment
(PPE) and other precautionary
measures
e Provision of appropriate and
good quality PPE
26. Policy guidelines on Document Review
laboratory biosafety © Local risk assessment reviewed
and biosecurity at least annually
@ Documented records of
conducted spill response drill
e Proof of documentation of spill
response drill (i.e., videos and
certificates)
e Records of fit test/s of all
personnel who uses respirator
based on risk assessment and
certificate of the fit test officer
updated at least annually or as
often as needed
© Workflow diagram of personnel,
sample, and waste using the
approved floor plan layout
@ Written protocols on laboratory
biosafety and biosecurity:
+ Biosafety Manual (Institution
specific/ Pathogen and
procedure specific)
+ Procedure for selection, use,
PPE donning and doffing
¢ Sample handling during
surges
+ Specimen receiving,
registration and handling
+ Specimen shipping and
transport
+ Specimen retention, storage
and disposal
+ Decontamination of work
surfaces
+ Emergency response
+ Biological spill response

Observe

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
0) 40 /292220
Page 11 off24
 e
INDICATOR
/ EVIDENCE

Laboratory door signage must

include biohazard symbol,
COMPLIED REMARKS

emergency contact person and

number, and personal protective
equipment requirement for each
room based on risk assessment
and other signage such as
donning/doffing procedures,
handwashing sequence and
related practices posted in
appropriate locations
e Availability and immediate
access to
spill kit and first aid kit
27. Policies and Document Review
procedures for © Written policies and protocols on
information security information security including
and access control database inventory
e List of authorized personnel who
can enter specific rooms in the
laboratory

Observe
e Limited access control is being
implemented in the facility
e Lock and key features are
provided
28. Technical procedures Document Review
of services provided in © Written policies, protocols,
each section are guidelines in the operation and
available maintenance of the laboratory
© Written and updated policies and
procedures for the following as
applicable;
« Decontamination of work
surfaces and items with 10%
bleach/ RNAse Away
followed by 70% ethanol
« RNA extraction
« Reagent or master mix
preparation
+ Template addition
« PCR running
« Analysis
« Trouble shooting
+ Blank work sheets
Additional requirement for
cartridge-based
e@
Sample loading
29 . Policies and Document Review
procedures for © Written protocol and procedures
innovations on the ofthe test method
diagnostic platforms © Certification from RITM
for rRT-PCR
e Test kits are FDA registered

Saliva Test:

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
0] 20/292 2q
Page 12 off24
 CRITERIA

©
INDICATOR
/ EVIDENCE

Verification Protocol from RITM

for use of Saliva as specimen for
COMPLIED REMARKS

RT-PCR

—
Pooled Testing:
@ Written recommended standard
technical protocol and guidelines
encompassing pre-analytical,
analytical, and post-analytical
processes set by the Philippine
Society of Pathologists, Inc.
(PSP), in coordination with
RITM
© Documented proof of
attendance
to training on sample collection,
documentation, and sample
pooling strategies provided by
the PSP through the Philippine
Children’s Medical Center
30. Documented reporting Document Review
to HFSRB or CHD- © Documented proof of report
RLED ofany changes submitted to HFSRB or CHD-
in management, name, RLED
ownership, or headship
or laboratory
personnel, as well as
physical plant or
equipment
A. Communication and Records
31. Procedures for the Document Review
receipt and e Written procedures for receipt
performance of and performance of COVID-19
COVID-19 testing testing.
e Written protocols for the
disinfection of the specimen
transport box before receiving
and after processing
@ Written protocol on acceptance
and rejection criteria of samples
© Documented records of remote
collection activities including
MOA and proof of notification to
HFSRB and/or CHD-RLED
32. Procedures for Document Review
reporting of results of © Written procedures for reporting
COVID-19 testing of results of COVID-19 testing
e Written protocol on acceptance
test results
e Documented proof of encoded
reports to digital platform such as
CDRS,
DOH
as recommended by the

33. Laboratory report Document Review

forms © Updated records of report
forms/results (logbooks/
electronically stored data with
back up) including entry,
releasing & endorsement

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00

Page 13 off24
 CRITERIA INDICATOR/ EVIDENCE COMPLIED REMARKS

e Laboratory report forms shall

have thefollowing:

__
—
¢ rRT-PCR platform used
+ Signatures of the following
either original/physically
affixed or digital
- Name of the HOL or
his/her associate
pathologist with signature
and PRC ID No.
- Name of the analyst RMT
who performed the
examination with
signature and PRC ID No.
- Name and signature of
senior analyst RMT who
validated the report, as
applicable
e@
Written policy or protocol on the
use of authenticated
electronic/digital signature thatis
in accordance with the E-
commerce law
© Documented policy for
Laboratory Information System,
if available
. Procedures for Document Review
reporting of workload, e Written procedures for reporting
quality control, of workload, quality control,
inventory control, and inventory control, etc.

eee.
other related
© Updated reports, documents
P
(hard or soft copy with back up)
e@
Worksheets/ machine print out
per section as proof of actual
performance
. Procedure for Document Review
reporting and analysis © Written procedures for reporting
of incidents, adverse analysis of incidents, adverse
ae
and
other related
ancivents
events,or other related incidents
© Compiled written reports with
resolutions
© Incident reporting forms
including zero incident reporting
. Procedures forthe Document Review
retention of records of @ Written procedures for the
the laboratory, retention of records which
pursuantto the DOH follows the latest standards
uidelines (DC No. promulgated by the DOH and/or
2021
seco and AO competent professional
No. 2022-0007) organizations
B. Quality Improvement Activities
. Policy on Quality Document Review
Assurance Program © Documented Internal QAP
(QAP) and Continuous including Internal Quality
Quality Improvement Control (QC) and Continuous
Quality Improvement
© Updated conducted QC reports
| “/
L 4
U DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00

Page 14 off24
 CRITERIA INDICATOR
/ EVIDENCE

Available reference materials

and
COMPLIED

Appropriate reagents
equipment used
Results/findings of QAP audits/
assessments
38. Participation in Document Review
Proficiency Testing © Written procedure in the actual

a
(P T) and/or its performance of proficiency
equivalent given by testing, and/orits equivalent
pa tojthe
Certificate of Proficiency and/or
Sear
©

its equivalent
39. Participation in the Document Review
Laboratory Network © Written procedure in the actual
External Quality performance of EQAP activities
peel
in
(EQAP)
Eropran)
accordance
with DM No. 2021-
© Certificate of Performance in
EQAP with passing rate
Roane
0332. e Proof of the following:
« EQA participation and
records of troubleshooting
done by laboratory

management if the EQA

results are less than 100%
« Submission to the Daily KPI-
LQIdata entry or the
acknowledgement email
« Results of Laboratory
Assessment, if applicable,
copy of the report from
RITM QA Team, records of
actions done to address
findings and/or
recommendations forquality
improvement (accomplished
Root Cause Analysis -
Corrective Action Plan form)
C. Referral of COVID-19 Testing
40. Policy on referral of Document Review
COVID-19 tests © Written procedures on referral of
examinations to other DOH-
licensed COVID-19 TL
e Records of referred COVID-19
tests (pursuant to the DOH
zoning guidelines)
e Notarized Memorandum of
Agreement (MOA) or _ its
equivalent
e DOH-LTO of the referral
COVID-19 TL
VII. PRICES
The COVID-19 TL shall adhere to the mandated price cap and shall make their prices accessible to the public as mandated by
the UHC law and related DOH issuances.
A. Price Transparency
list

a
41. The price shall be Document Review
readily available to the Price list is updated at least
public and regularly annually or pursuant to the
updated inaccordance current DOH policies and
guidelines
=. onan e100
(i DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
01 20/2922 2g
Page 15 off24
 CRITERIA
with the DOH policies
and guidelines
42. Availability of
Information,
Education, and
Communication (IEC)
material
May be presented in any of
the following form:
+ Printed handout
« Menu booklet
« Interactive digital form
(ex. Use of tablets and
computers)
+ Posters or tarpaulins
43. Submission of
information regarding
its prices and charges
for the COVID-19
tests, as requested by
DOH
B. Charging of Pric:
44, Prices charged for
COVID-19 testing
does not exceed the
mandated price range
issued by the DOH
Observe
INDICATOR
/ EVIDENCE COMPLIED REMARKS
e Aclear copy of
the updated price
list is posted in conspicuous areas
within the premises of the
laboratory and
public
is
accessible to the
e Updated price list
is available on
the official website of the
COVID-19 TL, for COVID-19
TL with an official website
Document Review
© Official IEC material developed
by DOH with DTI
© Guidelines for the
implementation of Executive
Order No. 118 on Regulation of
Prices for COVID-19 RT-PCR
testing Frequently Asked
Questions (FAQs)
e Prescribed Price Range for
COVID-19 Testing
Document Review
© Proof of submission of data to
the DOH
eS
Document Review
@ Price list
e@
Payment related documents (ex.
Charge slip, official receipt
issued)
Interview
© Clients in line for COVID-19
testing
Observe
e Actual testing charge:
PhP
DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
0| 202922 240%
Page 16 off24
 PART III. LIST OF EQUIPMENT

ee
A. Spill Kit!
The facility,
through the designated biosafety officer shall ensure that laboratory spills clean-up
are initiated abruptly in the safest way possible to minimize the risk of infection.
Contents and Supplies
e Instructions or procedures for the spill clean up Box of gloves
e Autoclavable biohazard waste bags (large and Paper towels or absorbent cloths
small) Hand-disinfectant and/or Soap
e Disinfectant (fresh sodium hypochlorite solution Sharps container
or phenol-derivatives) Dustpan and brush
e Disposable laboratory gowns (2-4) Hypochlorite Solution (freshly prepared)
e Goggles (2 pairs) Forceps
e Respirators (N95)
NOTE: Another spill kit may be prepared, which can be placed outside the containment laboratory.

B. Laboratory Equipment, Furniture and Supplies Required

The facility should make sure that the following equipment/supplies/furniture are available atall
times.
Equipment and Supplies
The following are minimum recommended equipment for the following workstation:
e Non-Cartridge Based Remarks e Cartridge Based Remarks
Specimen Receiving a. Equipment, Reagents and
Biological Safety Cabinet Supplies
Class II A2 e Autoclave
e Biomedical Refrigerator e Biomedical refrigerator
(2-8° C) (2-8° C) for reagents
e Gloves (different sizes) (cartridges)
b. Specimen Handling / e Biomedical refrigerator
Specimen Preparation (2-8° C) for specimens
e Autoclave e Biological Safety Cabinet
e Biological Safety Cabinet Class II A2
Class Il A2 e Rapid PCR Machine with
e Biomedical refrigerator (2- kits or cartridges (e.g.
8° C) with freezer (-20° C) GeneXpert System)
e Computer for accessioning
e Gloves (different size)
Heating block (for
extraction kits that requires
heating for elution buffer)
Microcentrifuge
Micropipette tips
Minicentrifuge
Set of four adjustable-
volume micropippettes
with rack:100-1000 1, 20-
200 ul, 2-20 ul, and 0.5-
10ul
Vortex mixer
Template Adding Room b. Personal Protective
eecie

Gloves (different sizes) Equipment

aa
PCR cabinet
i
~~ |
/
;
Tuberculosis laboratory biosafety manual. Geneva: World Health Organization; 2012
DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
&1
Page 17 of 24
Equipment and Supplies
The following are minimum recommended equipment for the following workstation:
e Non-Cartridge Based Remarks e Cartridge Based Remarks
e Minicentrifuge Disposable laboratory
Vortex mixer gown
eaje
Reagent Preparation Laboratory shoes
Biomedical Refrigerator (2- Powder-free nitrile gloves
8° C)
Biomedical freezer (-20° C)
Respirator: N95
or higher
for reagents
Gloves (different sizes)
Microcentrifuge
Micropipette tips
Minifuge
PCR cabinet
Set of four adjustable-
volume micropippettes with
rack:100-1000 1, 20-200 ul,
2-20 ul, and 0.5-10ul
Vortex mixer
Amplification/PCR
Minicentrifuge or plate
spinner
Real-time PCR machine
NOTE: The quantity of the above-mentioned may be increased depending on purpose, manpower and workload of the laboratory.
4/

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
202922 94
Page 18 ofa
PART IV. RISK ASSESSMENT
Accomplish the latest Annex 2 Risk assessment template of WHO document titled “Laboratory
biosafety guidance related to coronavirus disease 2019 (COVID-19)” Interim guidance 12 February
2020, accessible via this link: https://apps.who.int/iris/handle/10665/331138.

Labor iosafety guidance related to coronavirus disease 2019 (COVID-19): interim recommendation:

Annex 2 Risk assessment template

Although a qualitative approach to combining likelihood and severity parameters in a risk matrix is provided as a method for
risk evaluation here,itis important to note that quantitative (for example, from simple numerical scoring schemes to complex
mathematical models) and hybrid (semi-quantitative) methods can also be used for risk evaluation. Laboratories should use a
risk-evaluation/assessment method that best meets their unique needs, without excluding the possibility of developing
customized evaluation approaches, scoring methods and definitions of the parameters.

While this template was primarily developed for biosafety risk assessment, it
can also be used for general safety risk
assessment of laboratory activities, especially when the biosafety and general safety risks are
interlinked, for example, sample
collection and transport, where appropriate and applicable.

Institution/Facility name
Laboratory name
Laboratory manager/Supervisor
Project titles/Relevant standard operating
procedures (SOPs)
Date

If using this template, complete all sections following the instructions in the grey boxes. The instructions and
bullet points in the grey boxes can be copied into the text boxes beneath the instructions and used as prompts:
to gather and record the necessary site-specific information. The grey instruction boxes can then be deleted,
and the text remaining will form a risk assessment draft. This draft must be carefully reviewed, edited as
necessary and approved by the members of the risk assessment team.

STEP
1. Gather information (hazard identification)

Instructions: Provide a brief overview of the laboratory work and summarize the laboratory activities to be
conducted that are included in the scope of this risk assessment.
Describe the biological agents and other potential
hazards (for example, transmission, infectious dose,
treatment/preventive measures, pathogenicity).
Describe the laboratory procedures to be used (for
example, culturing, centrifugation, work with sharps,
waste handling, frequency of performing the laboratory
activity).
Describe the oe. eek on Ae
types of equipment to be used (personal
E

protective equipment [PPE], centrifuges, autoclaves,

_biological safety cabinets [BSCs]).
Describe the type and condition of the facility where
z

-
work is conducted,
Sire kta
Describe relevant human factors (for example
competency, training, experience and attitude of
personnel). : : a
Describe any other factors that may affect laboratory
operations (for example. legal, cultural
socioeconomic)

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
a4 13,
Page 19 o
 Laboratory biosafety guidance related to coronavirus disease 2019 (COVID-19): interim recommendations

STEP
2. Evaluate the risks
Instructions: Describe how exposure and/or release could occur.
What potential situations are there in which exposure
or release could occur?
What isthe likelihood of an exposure/release
occurring?
e Unlikely: not very possible to occur in
the
near future
¢ Possible: feasible to occur in the near future
e Likely: very possible to occur in the near
future
What isthe severity of the consequences of an
exposure/release (negligible, moderate, severe)?

Instructions: Evaluate the risk and prioritize the implementation of risk control measures. Circle the initial (inherent) risk of the
laboratory activities before additional risk control measures have been put in place.
Note:
© When assigning priority, other factors may need to be considered, for example, urgency, feasibility/sustainability of risk
control measures, delivery and installation time and training availability.
© To estimate the overall risk, take into consideration the risk ratings for the individual laboratory activities/procedures,
separately or collectively as appropriate for the laboratory.
Likelihood of exposure/release
Unlikely Possible
Consequence of Severe
exposure/release Moderate
Negligible
Laboratory activity/procedure Initial risk Is the initial risk Priority
(very low, low, medium, above the tolerance (high/medium/low)
high, very high) level?
(yes/no)

Select the overall initial risk.

Should work proceed without additional risk

control measures?
Dyes No

STEP
3. Develop a risk control strategy
Instructions: List any requirements that have been prescribed by international and national regulations.
legislation, guidelines, policies and strategies on biosafety and biosecurity.
Describe the measures required by national legislation
or regulations(if

4
any) al
Describe the measures advised by guidelines, policies
(if
and strategies any). rnd

Instructions: Describe the resources available for risk control and consider their applicability, availability and
sustainability in the local context, including management support.

10

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
o 29d
Page 20 o
 Laboratory biosafety guidance related to coronavirus disease 2019 (COVID-19): interim recommendations

Are resources sufficient to secure and maintain

potential risk control measures?
What factors exist that may limit or restrict any of the
tisk control measures?
Will workbe able to proceed without any ofthe risk
control measures; are there alternatives?

STEP
4. Select and implement risk control measures

Instructions: Describe where and when risk control measures are needed, the level of residual (remaining)
risk when these risk control measures are in place, and an assessment of
the availability, effectiveness and
sustainability of the risk control measures.
Are risk
control
Is the residual measures
Residual risk risk above the available,
Selected risk (very low, low, tolerance effective and
control medium, high, level? sustainable?
Laboratory activity/procedure measure(s) very high) (yes/no) (yes/no)

Instructions: Evaluate the residual risk that remains after risk control measures have been selected, to
determine whether that level of risk is now below the tolerance level and whether work should proceed.
Circle the residual risk of the laboratory activities after risk control measures are in place.
Likelihood of exposure/release
Unlikely Possible Likely
Severe
Consequence of Moderate
exposure/release
Negligible

Overall residual risk:

If the residual risk is still above the risk tolerance level, further action is necessary, such as additional risk
control measures, based the initial risk evaluated in STEP 2, redefining the scope of work such that it falls
on

below the risk tolerance level with existing risk control measures in place, or identifying an alternative
laboratory with appropriate risk control strategies already in place that is capable of conducting the work as
planned.
Should work proceed with selected risk OYes ONo
control measures?
Approved by (name and title)
Approved by (signature)
Date

Instructions: Describe how to communicate risks and risk mitigation strategies to personnel. Provide a
mechanism of communication within the laboratory. Describe the process and timeline for ensuring that all
identified risk control measures are purchased and have associated SOPs and training has been completed
before starting the laboratory work.
Communication of the hazards, risks and risk control

bre
measures
oa
Purchase (and budgeting) of risk control measures -

Operational and maintenance procedures Oe

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
0} Magna
91

Page 21 of
 ry biosafety guidance related to coronavirus disease 2019 (COVID-19): interim recommendations

[ Training of personnel I za

STEP
5. Review risks and risk control measures

Instructions: Establish a periodic review cycle to identify: changes in laboratory activities, biological agents,
personnel, equipment or facilities; changes in knowledge of
biological agents or processes; and lessons learnt
from audits/inspections, personnel feedback, incidents and/or near misses.
Frequency of the review
Personto conduct the review
Describe updates/changes
Personnel/procedures to implement the changes
Reviewed by (name and title)
Reviewed by (signature)
Date

DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00
| 2932
29

page 22 offs
 Republic of the Philippines
Department of
Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Facility:
Date of Inspection:

=<
RECOMMENDATIONS:
For Licensing Process
{] For Issuance of License to Operate as:
to
Validity from ————_____—

[] Issuance depends upon compliance to the recommendations given and submission of the
following within days from the date of inspection.

[ ] Non-issuance.

Specify reason/s:

Inspected by: Printed Name Signature Position/Designation

Received by:

Signature
Printed Name
Position/Designation
Date

DOH-HFSRB-QOP01-Covidi9TL-AT
Revision: 00
oh 400
Page 23 of 24
 Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Facility:
Date of Monitoring:

RECOMMENDATIONS:
For Monitoring Process
[ ] Issuance of Notice of Violation.

[] Non-issuance of Notice of Violation.

[] Others. Specify:

Monitored by:
Printed Name Signature Position/Designation

Received by:
Signature
Printed Name
Position/Designation
Date

in)
DOH-HFSRB-QOP01-Covid19TL-AT
Revision: 00.

dae
Page 24
 A.O. No. ~023-0004
ANNEX C
Republic of the Philippines
Department of
Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

GUIDELINES IN MANDATORY NOTIFICATION OF REMOTE COLLECTION

ACVITITY OF NUCLEIC ACID AMPLICATION TEST BASED COVID-19 TESTING
LABORATORIES

The Health Facilities and Services Regulatory Bureau (HFSRB) shall be notified for all remote
collection activities (RCA), including home/hotel/quarantine facility collection, conducted by
DOH Licensed COVID-19 TL, DOH-registered freestanding
collection sites or DOH licensed
COVID-19 testing laboratories (TL) and with satellite collection site.

II. Only the DOH licensed COVID-19 TL, performing NAAT based for SARS-CoV-2 detection
shall notify the HFSRB, and not the party which has a Memorandum of Agreement (MOA)
with the DOH licensed COVID-19 TL.

WI. The COVID-19 TL shall notify the HFSRB three (3) days prior to the proposed schedule of
the RCA. In the event that the RCA will be done repeatedly in the same place for a given
period of time, one (1) notification letter indicating the schedule of the RCA and number of
requested tests will suffice.

IV. For urgent specimen collection requests, the notification can be done after sample collection
or within the day of sample collection by the DOH licensed COVID-19 TL.

The remote collection notification shall be valid only up to the date of the last collection as
reflected in the notification. In case of failure to conduct the collection at the specified date,
the COVID-19 TL shall inform the HFSRB in writing, at least within 48 hours before the
scheduled date of remote collection and shall inform the new schedule.

VI. The remote collection site shall be located within the same region, at a maximum of one
hundred (100) kilometre distance, from the address of DOH licensed NAAT based COVID-
19 TL.

VII. The notification may be submitted through any of the following modes: postal mail, e-mail,
via courier service, or walk-in submissions with the letter of intent. The mandatory notification
for the conduct of RCA shall indicate the following:
p Name of COVID-19 TL with DOH-LTO number
Complete Address of the DOH licensed COVID-19 TL (refer to LTO)
MOO
Complete Location of the remote collection site (where RCA will take place)
Schedule of the RCA (Indicate the start and end date)
Specimento be collected (NPS/OPS/Saliva)
Target of
number samples per day
DOM
of
Estimated number clients/patients for the whole RCA schedule
Complete Name of Specimen Collector/Swabbing Entity, if applicable:
1. Copy of Certificate of Registration
2. Acopy of the notarized MOA/MOU between the freestanding collection site and the
DOH licensed COVID-19 TL

VIII. A copy the official mandatory notification letter, received and stamped/acknowledged by
of
HFSRB or CHD-RLED shall be available on-site during the RCA. :

1
 IX. The specimen collection shall be done preferably by the employed staff of the NAAT based
COVID-19 TL or
their authorized/designated trained personnel. Specimen collectors should
have undergone training from the Research for Tropical Medicine (RITM) or from other
DOH/RITM recognized training providers, equipped with necessary supplies and personal
protective equipment needed for specimen collection, handling and transport.

The remote collection site shall have a proper area for specimen collection and shall adhere to
the current DOH specimen collection protocol and to the DOH policy on healthcare waste
management.

XI. No
testing or processing of specimens shall be done in the remote collection sites and the
specimens must be handled properly, sealed in required packaging and transported for a
maximum of within 48 hours or
in accordance with the standard operating procedure of DOH
licensed NAAT based COVID-19 TL, whichever is earlier, to ensure the quality of the
specimen.

XII. Case Investigation Form, along with the specimen collected, shall be evaluated for correctness
and completeness by thestaff/specimen collectors in the remote collection site.

XIII. The NAAT based COVID-19 TL shall maintain records of all remote collection performed.
There shall also be record of temperature monitoring of refrigerator or transport box during
RCA.

XIV. The HFSRB or CHD-RLED may inspect the remote collection site or monitor during the
actual collection.

XV. The price for specimen collection/swabbing shall be in accordance with the latest DOH
guidelines on price cap for COVID-19 testing.

XVI. Failure to notify the HFSRB or the CHD-RLED of the proposed remote collection activity
shall merit the appropriate sanction as reflected in this Order.

XVII. Violations of the guidelines stated herein, and related policies or laws shall be the basis for
suspension/revocation of the DOH-LTO of the DOH licensed COVID-19 TL and the
Certificate of Registration of the freestanding/standalone collection site.

ap 4
 A.O. No. 2022-1015 - ODD4-
ANNEX D
Republic of the Philippines
Department of Health
=/ HEALTH FACILITIES AND SERVICES REGULATORY BUREAU
PLANNING AND DESIGN GUIDELINES FOR A COVID-19 TESTING LABORATORY

GENERAL CONSIDERATIONS

A. Risk assessment. A detailed risk assessment must be carried out first in order to determine
the specific risk control measures that need to be implemented and
a facility-specific needs
assessment to define all other design features needed for the laboratory before the
construction, repurposing or renovation of a COVID-19 testing laboratory.

Location. Design and location of the COVID-19 testing laboratory shall be appropriate to
the laboratory needs. The COVID-19 testing laboratory shall be located
away from
residential, high density commercial and similar areas where the facility may impose harm
to the general public. It shall be located and arranged to prevent non-related traffic
throughout the facility. As such, institution-based COVID-19 testing laboratories may be
separate building or in an area located behind or away from common walkways between
other rooms or buildings of the health facility. Provision of perimeter fence to ensure
security shall also be provided.
Access. Access to rooms/areas intended for testing, specimen handling and the like shall be
restricted to authorized personnel only. Access to the COVID-19 testing laboratory
per se
shall be limited to authorized and concerned individuals. Mechanism for such access
restriction to authorize personnel shall be in place (e.g. key card lock, administrative
control).

Conformance with Building Laws. The COVID-19 testing laboratory shall conform to all
applicable local and national regulation for the planning and design, construction,
renovation, maintenance and repair of its facilities. As such, all plans and drawing
requirements such architectural, civil, electrical, lighting and power, sanitary and plumbing
and mechanical, and other related trades shall be in accordance with all relevant and
existing laws of the Philippines as applicable.

Utilities. COVID-19 testing laboratory must be provided with appropriate utilities

including clean running water, lighting, ventilation, electric outlets, back-up power,
adequate lighting, drainage systems that comply with environmental regulations, and
sanitation facilities for staff.

Ventilation. Controlied environment and adequate ventilation with the acceptable air
changes per hour and pressure differential, if applicable, shall be maintained for each
specific area of the COVID-19 testing laboratory.

i. FUNCTIONAL AND SPATIAL CONSIDERATION

A. Spaces Required, The COVID-19 testing laboratory shall have adequate

space or area
provided for its various space/room requirements in order to attain the effective and
efficient operation ofits
activities and functions to provide services
to
clients.
1. For COVID-19 laboratories using the non-cartridge-based technology to detect SARS-
CoV-2 such as real time reverse transcriptase polymerase chain reaction (tRT-PCR),
there shall be a dedicated space for each of the following activities:
pH 1
DOH-HFSRB-QOP01-PDG-PTC-Covid19TL
Revision: 00
Olay 023
Page 4 of
 a. Pre-analysis (Specimen receiving/unboxing, virus inactivation and nucleic acid
extraction (Pre-PCR), and template adding);
b. Reagent storage and handling;
c. Analysis (PCR); and
d. Clerical activities (encoding and post analysis)
For the Pre-Analysis’, dedicated areas or separate room/s for specimen
receiving/unboxing, specimen handling, and template adding, shall be provided.
Provision of separate rooms for the specimen receiving/unboxing, specimen
handling/virus inactivation and nucleic acid extraction, and template adding,
recommended.
highly is
2. For COVID-19 laboratories using the cartridge-based technology to detect SARS-CoV-
2, there shall be a dedicated space for each of the
following activities:
a. Pre-analysis (Specimen reception and Sample preparation)
b. Analysis (Specimen Processing)
c. Clerical activities (encoding and post analysis)
Pre-analysis and analysis activities may be done ina single room provided that adequate
and appropriate spaces shall be provided for the aforementioned activities. Provision of
separate rooms for the aforementioned activities is highly recommended.

. Unidirectional workflow following the above mentioned activities shall be maintained at

all times (clean to dirty).

. Clean Write shop for the clerical activities (data encoding, result generation, reporting)
shall be located outside of the clinical work areas but adjacent or easily accessible to
prevent contamination.

. Additional facilities for personnel use, such as, but not limited to, toilet (with at least
lavatory/sink and water closet), staff lounge/pantry, lockers (if
any), laundry area (if any),
and office facilities (if any) must be located outside of the clinical work areas but easily
accessible to prevent contamination. Doffing and donning areas for personnel to leave and
store personal items, outer garments (coats) and clean laboratory coats must be provided.

. Facilities for specimen collection may also be provided. Separate room/area for the
specimen collection, shall not within the main laboratory premises but shall be accessible
and within the site, shall be available for sample collection activities. Collection or
swabbing must be done in an area where foottraffic is less or controlled. Consideration
must be given to patient access, comfort, privacy and infection prevention and control.
Collection area shall have an adequate and ventilated space for specimen collection.
Physical distancing shall be observed in the waiting area all times.
at
. There shall be sufficient, secured and appropriate storage spaces and conditions provided
for laboratory specimens, documents, records, manuals, equipment, reagents, supplies,
slides and tissue blocks, both for long term and short term basis. Physical security of
specimens and reagents may also need to be considered depending on the
risk assessment.
. The different areas of the COVID-19 testing laboratory shall be planned functionally
related to each otherto attain efficient workflow. Unidirectional workflow in the clinical
work areas (clean to dirty) shall be maintained atall times.
. The COVID-19 testing laboratory shall have appropriate and adequate space allocated for
the performance of itswork, and is designed to ensure the quality, safety and efficiency of
the service provided to the user and the health, safety and comfort of laboratory personnel.
A DOH-HFSRB-QOP01-PDG-PTC-Covid19TL
Revision: 00
OL ey pol,
Page 2 of 7
 The laboratory shall evaluate and determine the sufficiency and adequacy of the space
allocate for the performance of the work to accommodate its
activities and allow for smooth
and coordinated work flow.

The clinical work area shall be sufficient to accommodate its

activities and allow for
smooth and coordinated workflow. Rooms intended for
its
sections shall be planned to meet
the workload described in the functional program.

Laboratory owners, architects, engineers and other stakeholders may utilize Annex F1 or
the Sample Floor Plan for Cartridge-based COVID-19 Testing Laboratory and/or Annex
F2 or the Sample Floor Plan for Non-cartridge-based COVID-19 Testing Laboratory of this
Order, as a guide in planning and designing the physical layout of their proposed COVID-
19 Testing laboratories.

III. SPECIFIC TECHNICAL REQUIREMENTS

A. Fire Safety. The COVID-19 testing laboratory shall conform to the applicable provisions
of the 2019 Revised Implementing Rules and Regulations (IRR) of Republic Act (RA)
9514 or the Fire Code of the Philippines. As such, installation of safety systems for fire,
including fire alarms, must be considered. There shall also be at least Class C-capable fire
extinguisher/s in the laboratory.

Corridors. The minimum width for corridor in a COVID-19 testing laboratory shall be at
least but not limited to 1.20 meters or four (4) feet to allow easy delivery, efficient conduct
of activity, and removal and replacement
of laboratory equipment. Wider corridors shall be
provided taking into consideration of passage of large equipment, movement of people and
the activity involved. Also, these corridors and exits shall comply with the statutory code
of practice and mustbe kept clear at all times to allow emergency exit.
Clearances. Adequate clearances intended for working space in the clinical work area shall
be provided, with consideration to the size and type of equipment, activity involved,
ergonomics and anthropometrics of the personnel.

Emergency eyewash. Emergency eyewash, preferably hands-free, shall be provided inside

the laboratory, preferably in the pre-analysis room or on
quantity of such shall be based on the risk assessment.
its
doffing area. Locations and

Hand-washing. Hand-washing facilities must be provided in the laboratory where clinical

procedures, including waste handling, are performed, and in the doffing and donning areas.
Running water must be available, preferably operated by a hands-free mechanism.
Pass box. Adequate and appropriate pass boxes shall be strategically installed in the clinical
working areas for the transport of specimen and wastes within the COVID-19 testing
laboratory. For internal pass box, it must have a minimum approximate internal dimension
of 0.30m x 0.30m x 0.30m. For specimen receiving pass box, it must have a minimum
approximate internal dimension of 0.40m x 0.40m x 0.40m. Electrical and/or mechanical
interlocking mechanism for the pass boxes shall also be installed.

Equipment, furniture and fixtures. Equipment, furniture, fittings and the facility itself
shall be designed and constructed to be safe, robust and shall be based on the functional
program. Large and complex equipment should be installed based on the manufacturer’s
specifications and recommendations. The following shall also be considered:
© Weight and dimensions of the equipment;
¢ Dimensionsof doors and corridors to allow passage of equipment and furniture;
DOH-HFSRB-QOP01-PDG-PTC-Covid19TL
4 Revision: 00
ai2es 023
Page 3 of 7
 * Proper Selection, installation and placement
space required for maintenance;
to
avoid risks and injury and adequate

Mechanical, environment and electrical requirements of the equipment;

© Dedicating equipment (in dedicated rooms) for use only for tasks with infectious
material to avoid cross-contamination; and
* Mounting and securing in position of equipment especially those sensitive to vibration
and movement.
Furniture mustbe smooth, easy to clean, impermeable to
liquids and resistant to the
chemicals and disinfectants normally used in the laboratory.
Biosafety Cabinets shall be installed in correct location, away from high traffic doors, air
supply/exhaust diffusers and alike that compromise its operation, as fluctuations in
air
supply and exhaust or the operations of equipment may alter the performance standard of
the cabinet/hood.
. Ceiling Height. The floor-to-ceiling height of the clinical work area shall be at least 2.60
meters in order to accommodate biological safety cabinet. Other rooms other than the

202%,
clinical work areas shall be compliant with the requirements of the National Building Code
of the Philippines, As such, there shall be at least 2.4 meters clear ceiling height for
artificially ventilated rooms and at least 2.7 meters for naturally ventilated rooms,
if any.
Electrical System. There shall be a stable and uninterrupted power supply and a back-up
power supply, to ensure continuity of services. Installation of uninterrupted power systems
(UPS) for essential equipment is recommended, to guarantee that ongoing
activities can be
finished in case of power failure and fluctuations.

Plumbing. Continuous and sufficient supply of potable water shall be made available atall
times. Piping systems shall be kept concealed as possible yet should be located where they
will be easily accessible for service and repairs with a minimum of disruption of the facility
operations.

- Information and Communication Technology (ICT). Provision for ICT and

communication systems are recommended for efficient operation of the facility, such as
intercom system, electronic access control system and alike. Installation of CCTV and other
security surveillance systems are recommendatory, for monitoring
in the COVID-19 TL.
of activities and safety
. Ventilation. Appropriate and adequate ventilation, exhaust and environmental control
requirements shall be given in the each rooms of the COVID-19 testing laboratory
depending on the functional program and risk assessment. There should also be sufficient
air exchanges and pressure differential, if applicable in each areas of the COVID-19 testing
laboratories, depending on the use and contents of the space.
1. COVID-19 testing laboratory’s ventilation and minimum air exchanges shall be as
follows:
Area Designation Pressure Differential to Minimum total
air change
adjacent area per hour (ACH)
Receiving Counter Neutral or Slightly
_
Negative
Pre-Analysis
Specimen Receiving Negative 12 ACH (equal or not
Room more than Sample
Preparation Room)

“ uu DOH-HFSRB-QOP01-PDG-PTC-Covid 19TL
Revision: 00
Of / Ly
Page 4of 7/
2 023
 Specimen Handling / Negative 12 ACH
Sample Preparation Room
Template Adding Room Neutral orSlightly
Gif a separate room) Negative, but less than
Analysis/PCR Room
Doffing Room Neutral or Slightly

__|
Negative but less than
Template Adding Room
Donning Room Positive or Neutral
Analysis / PCR Room Negative, but less than 6 ACH (but less than
Sample Preparation Room Sample Preparation
Room)
Reagent Preparation Positive
Room

Pre-analysis and analysis rooms shall have an exhaust that maintain adequate air
exchange.
The exhaust stack shall be at least 3 meters above the highest point of the roof 3 or
meters above the highest point of the roof of the adjacent building, whichever
stringent, and should be
distant to
other taller structures with open windows above. The
is
exhaust stack shall be oriented in an up-blast orientation and discharge shall be directed
vertically upward without having a gooseneck, elbow, cap or cover.
Additional exhaust requirements must be installed (e.g. bag-in bag-out (bibo) high
efficiency particulate air (HEPA) filter box) if the above criterion was not met, and if
the location of the laboratory may still impose risk to the surrounding.

Under no circumstances should the exhaust air from the specimen receiving and
specimen handling/sample preparation rooms be
recirculated to other areas.

The reagent preparation room shall have filtered air supply with a 90-95% efficiency.

Supply intake location must at least 7.62 meters (25 ft.) from the exhaust stack and in
opposite direction.

Exhaust air grille locations must be

of the biosafety cabinet.
in the dirty side of the laboratory preferably on top

Supply air grille locations were on the clean side of the laboratory preferably near
entrance doors.
Installation of pressure monitoring device (e.g. magnehelic gauge) per room for
monitoring pressure differential especially for specimen receiving area and specimen
handling room.
10. All air conditioning units must be
split type.
11. Air direction should be away from the biosafety cabinets, isolation hoods and alike.
12. Location of switch/es of the HVAC systems (AHU) shall be located outside the
laboratory or in the donning area of the laboratory, and shall be restricted from the
public.
As q

DOH-HFSRB-QOP01-PDG-PTC-Covid19TL
Revision: 00
ol 023
Page 5 of
M. Space. The COVID-19 testing laboratory shall provide adequate space or area for its
various space/room requirements in order to attain the effective and efficient operation of
its activities and functions. Adequate areas shall be provided for the procedure, people,
activity, furniture, equipment and utility within the space.
N. Material Specification. All finishes, work counters and furniture must be made of
monolithic, impervious (water proof, impenetrable, impermeable) easy to clean and made
up of Anti-bacterial/ anti-fungicidal chemical resistant material.
1. Walls and partition. All walls shall be structurally sound, safe, and sturdy with
minimum fire resistant rating as prescribed by the Fire Code of the Philippines for this
type of occupancy. Wall finish shall be with impervious, smooth, less terminations, and
easy to clean, with anti-bacterial/anti-fungicidal chemical resistant finishes.
Interior walls or partitions and walls shall be constructed from floor
prevent cross contamination and for fire safety compartmentalization.
to floor height to
Ceiling. The ceiling shall be structurally sound, monolithic, safe and made of sturdy
impervious (water proof, impenetrable, impermeable) materials and easy to clean, with
anti-bacterial/ anti-fungicidal chemical resistant finishes. The ceiling configuration of
the clinical work area should be as flat as possible and shall avoid edges and crevices
that are difficult to clean and to prevent accumulation of dirt in the ceiling. Lighting
fixtures in the clinical work area shall be surface-mounted with smooth cover and
maximum penetration from the ceiling.

Flooring. The floor material and finish must be monolithic, seamless, structurally
sound, safe and made of sturdy and impervious (water proof, impenetrable,
impermeable) materials, with anti-bacterial/ anti-fungicidal chemical resistant finishes
to
and easy clean. Floors shall be seamless with all corners and edges are curved/coved
at
to a height of least 6 inches (152.4 millimeters) towards the wall.

Work counters. Work counters shall be provided with finish that is monolithic,
seamless and does not support bacterial growth, durable, non-porous, resistant to heat
and chemicals, smooth and easy to clean and stain and dirt resistant. The width of the
work counter shall be at least 600mm (750mm or inches
30
ispreferred).
Sink or lavatory, preferably stainless steel, with faucet, preferably gooseneck, with
adequate supply of water shall be provided.
Backsplash or wainscoting is recommended, preferably with the same material with the
countertop finish or its equivalent with at least 400mm high. Edges and terminations of
the work counters shall have curved edges and sealed wherever possible for easy
cleaning.
Windows. The external/ internal windows inthe clinical working area shall employ
closed and fixed tempered/ safety glass window and shall be properly sealed/caulked.
Windows and openings in other areas shall be in compliance with the requirements of
Rule VIII of the National Building Code of the Philippines. If operable window
areas is utilized, it should be fitted with arthropod-proof screens.
in
these

Doors. All doors in the main COVID-19 TL shall be swing-type, fire rated, properly
and appropriately labelled, lockable and secured, have a self-closing mechanism and
shall adopt chemical resistant and easy to clean door finish. The minimum clear opening

a
for the main door/s of the COVID-19 testing laboratory and the clinical work area shall
4
DOH-HFSRB-QOP01-PDG-PTC-Covid19TL
Revision: 00
Ol/tpveeny,
0 Sa
23
Page 6 of
 be at least 1.00 meters in order to accommodate entry and exit of equipment and safe
movement of waste and materials.
Doors to the clinical work area must have a vision panel to see into the laboratory.
Internal laboratory doors must befitted with vision panels so that workers are visible
and to prevent collisions.

hospital-based COVID-19 testing laboratories, exits doors shall be at least one and
For
twelve hundredths meters (1.12 m) width.

7. Others. Carpeting, rugs, fabrics and other similar pervious and absorbent finishes shall
be avoided.
All room gaps and penetrations (passageways in the wall, floor, ceiling or other surface)
shall be properly sealed / caulked that the airtightness of the laboratory room or space
so

can be achieved for containment.

O. Waste Management. There shall be adequate and appropriate facilities for the efficient
handling, storage and management of wastes, including infectious wastes, in accordance
with the provisions of the latest edition of the DOH Health Care Waste Management
Manual, COVID-19 Waste Management Sourcebook, and other DOH issuances, Republic
Act 6969, and other relevant statutory requirements and code of practice.
Appropriate methods for decontamination of waste such as disinfectants and autoclaves,
must be made available within the laboratory. Secured and appropriate storage area/s for
general and hazardous wastes shall be provided.
P. Additional Requirements. The COVID-19 testing laboratory shall provide compliance for
additional requirements to consider heightened control measures based on the conducted
tisk assessment, in adherence with the requirements of laboratory biosafety and biosecurity,
to ensure a safe working environment. The heightened control measures implemented
should be appropriate and sufficient to reduce the specific risks that contribute to the
likelihood and/or consequence of an exposure and/or release.

ae |

DOH-HFSRB-QOP01-PDG-PTC-Covid19TL
Revision: 00
OL /do’s022,
4093
Page 7 of 7
 A.O, No.
2092 2023 - pno4
ANNEX E1

Republic of the Philippines

Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

CHECKLIST FOR REVIEW OF FLOOR PLANS

COVID-19 TESTING LABORATORY USING CARTRIDGE-BASED TECHNOLOGY

Name of Health Facility:

Address:
Date: Review: 1* gna 3"

1. PHYSICAL PLANT
___1.1.Clinical Work Area
___1.1.1. Receiving Area/counter (may be within or located outside but accessible
the main laboratory)
___1.1.1.1, Pass box going to Pre-Analysis Room
___1.1.2. Processing Room
___1.1.2.1. Anteroom/Donning Room with handwashing sink, PPE
rack
1.1.2.2. Pre-Analysis Room/area with work counter and laboratory
___
deep sink
___1.1.2.3. Pass box going to Analysis Room (not required if the pre-
analysis and analysis are in the same room)
___1.1.2.4. Anteroom/Doffing Room with handwashing sink and
hamper
___1.1,2.5. Analysis Room/Area with work counter and laboratory
deep sink (may be within the pre-analysis room (separate
sink not required))
___1.1,3. Clean Write Shop / Post-Analysis Room
___1.2. Support Area
___1.2.1. Storage Area for Records and Supplies *
___1.2.2. Waste Holding Room/Area *
___1.2.3. Staff Toilet with lavatory/sink (located outside or away from the clinical
work area) *
___1.2.4. Pathologist room/ area *
___1.2.5. Specimen coilection area (located outside or away from the clinical work
area) (optional)
1.2.6. Staff lounge / pantry (located outside or away from the clinical work
area)*
1.2.7. Laundry area (located outside or away from the clinical work area)
(optional)*
Notes:
This checklistfor review offloor plan is only applicable for COVID-19 Testing laboratories (COVID-19 TL) performing
cartridge-based technology in detecting SARS-COV2 (e.g. GeneXpert).
it
*. Optional for institution-based COVID-19 TL, provided is identified within the DOH-regulated health facility the
COVID-19 TL is located, and is accessible from the COVID-19 TL.

2. PLANNING AND DESIGN

2.1, Floor plan must be
properly identified and completely labeled.
2.2. Doors, windows, fixtures, furniture, and equipment are properly laid out.
2.3. Meets prescribed functional programs:
2.3.1. Zoning Requirement:
Ad DOH-HFSRB-QOP01-Covid19TL CBT-PTC-CR
Revision: 00
oly
H3
Page
1 of
 ____2.3.1.1.Laboratory location shall have less foot traffic yet accessible
for receiving of specimen.
____2.3.1.2. The flow of traffic of specimen going to specimen receiving
counter shall not pass through general public areas.
___2.3.2. Floor plan suggests unidirectional workflow process from receiving of
specimen to
results data processing as applicable.
___2.3.3. Rooms housing large equipment and areas leading to it shall have at least
one door with at least 1.00 meter clear width to accommodate entry and
exit of equipmentas applicable.
____2.3.4, Internal windows are laid out to promote visual observation between work

2.3.5.
roomsas applicable.
Provision for toilet and other amenities for laboratory staff are located
___ outside but easily accessible to prevent contamination.
____2.3.6. Presence of Perimeter fence / well-secured location within the building.
2.4. Conforms to the applicable codes as part of normal professional practice.
Exits restricted to the following types: door leading directly outside of the
____2.2.1.
building, interior stair, ramp, and exterior stair.
___2.2.2. Minimum of two (2) exits as remote as possible from each other.
___2.2.3. Exits terminate directly at an open space to the outside of the building.

3. MECHANICAL PLAN
3.1. The pre-analysis room shall have a negative pressure room conditioned and its exhaust
must produce at least 12 air changes per hour (ach).
3.2. The analysis room shall have a negative pressure room conditioned and its exhaust must
produceat least 6 ach.
3.3. The exhaust stack shall be at least 3 meters above the highest point of the roof or 3 meters
abovethe of
highest point of the roof the adjacent building, whichever is stringent, and
be
should distant to other taller structures with open windows above. The exhaust stack
shall be oriented in an up-blast orientation and discharge shall be directed vertically
upward without having a gooseneck, elbow, cap or cover.
3.4. Additional exhaust requirements must be installed (e.g. bag-in bag-out (bibo) high
efficiency particulate air (HEPA) filter box) if the above criterion was not met, and
the location of the laboratory may still impose rist to the surrounding (if applicable).
if
3.5. Supply intake location must at least 7.62 meters (25 ft.) from the exhaust stack and in
opposite direction.
3.6. Exhaust air in
grille locations must be
of the biosafety cabinet.
the dirty side of the laboratory preferably on top

3.7. Supply air grille locations were on the clean side of the laboratory preferably near
entrance doors.
3.8. All air conditioning units must be split type.
3.9. Air direction should be away from the biosafety cabinets and other containment
equipment (if any).
3.10. Under no circumstances should the exhaust air from the pre-analysis room/ processing
room be recirculated to other areas.

COMMENTS:

my } DOH-HFSRB-QOP01-Covid19TL CBT-PTC-CR
Revision: 00
Oh do:
Page 2 of
 Republic of the Philippines
Department ofHealth

Name
of
Address:
Health Facility:

Date:

COMMENTS:

HEALTH FACILITIES EVALUATION AND REVIEW COMMITTEE (HFERC)

[ ] Approved [ ] Disapproved

Chairperson, HFERC

Vice-Chairperson, HFERC

Member Member Member

Member Member Member

AM DOH-HFSRB-QOP01-Covid19TL CBT-PTC-CR
Revision: 00
OL/:

Page 3 of 3
 A.O. No. 2023 - 0004
ANNEX E2

Republic of the Philippines

Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

CHECKLIST FOR REVIEW OF FLOOR PLANS

COVID-19 TESTING LABORATORY USING NON-CARTRIDGE-BASED TECHNOLOGY

Name
of
Address:
Health Facility:

Date: Review: 1% and 3%

1. PHYSICAL PLANT
___1.1. Clinical Work Area
___1.1.1. Receiving Area/counter (may be within or located outside but accessible the
main laboratory)
1.1.1.1. Pass box going to Pre-Analysis Room
___1.1.2. Pre-Analysis Room/s for Specimen Receiving and Specimen
Handling/Sample Preparation
___1.1.2.1. Anteroom for Donning with handwashing sink and PPE Rack
___ 1.1.2.2. with
Specimen Receiving/Unboxing Room/Area with work counter
laboratory deep sink
___1.1.2.3. Specimen Handling/Sample Preparation Room/Area with work
counter with laboratory deep sink
___1.1.2.4. Pass box connecting to Reagent Preparation Room (optional)
___1.1.2.5. Pass box connecting to Analysis Room (n/a if with template
adding room/area)
___1.1.2.6. Anteroom for Doffing with handwashing sink and Hamper
1.1.3. Template Adding Room/Area (n/a if using fully-automated RNA extraction)
____
If a dedicated area only (it must be located in the clean side of the sample
preparation room);
___1.1.3.1. Work Counter
___1.1.3.2. Pass box connecting to Analysis room
Ifa separateroom;
___1.1.3.3. Work Counter with Laboratory deep sink
___1.1.3.4. Pass box connecting to Pre-analysis room
___1.1.3.5. Passbox connecting to Reagent Preparation Room (optional)
___1.1.3.6. Passbox connecting to Analysis Room
___1.1.4, Reagent Preparation Room
___1.1.4.1. Work Counter with Laboratory deep sink
___1.1.5. Polymerase Chain Reaction (PCR) Room / Analysis Room
___1.1.5.1. Work Counter with Laboratory deep sink
___1.1.6. Change Room/s for Donning and Doffing with hand washing sink, PPE
Rack and Hamper
___1.1.7. Clean Write Shop / Post-Analysis Room
___
1.2. Support Area
___1.2.1. Storage Area/s for Records and Supplies *
___1.2.2. Waste Holding Room/Area *
Staff Toilet with lavatory/sink (located outside or away from the clinical
___ 1.2.3. work area) *
___1.2.4. Pathologist room/area *
___1.2.5. Staff Pantry / lounge (located outside or away from the clinical work area) *

wl 4 DOH-HFSRB-QOP01-Covid19TL NCBT-PTC-CR
Revision: 00
Ol
Base, 023
Page of1
 1.2.6. Specimen collection area (located outside or away from the main
laboratory) (optional)
1.2.7. Laundry area (located outside or away from the clinical work area)
(optional)*
Notes:
This checklist for review offloor plan is only applicable for COVID-19 Testing laboratories (COVID-19 TL) performing
non-cartridge-based platform in detecting SARS-COV2 (e.g. Real time Reverse Transcriptase (rRT) PCR).

COVID-19 TL located, and is it

*- Optional for institution-based COVID-19 TL, provided is identified within the DOH-regulated health facility the
is accessible from the COVID-19 TL.

2. PLANNING AND DESIGN

____2.1. Floor plan must be properly identified and completely labeled.
____2.2. Doors, windows, fixtures, furniture, and equipment are properly laid out.
___2.3. Meets prescribed functional programs:
___ 2.3.1. Zoning Requirement:
2.3.1.1. Laboratory location shall have less foot traffic yet accessible
___ for receiving of specimen.
____2.3.1.2. The flow oftraffic of specimen going to specimen receiving
counter shall not pass through general public areas.
___2,3,2. Floor plan suggests unidirectional workflow process from receiving of
specimen to
results data processing as applicable.
___2.3.3. Service Corridor, if any, has a minimum clear and unobstructed width of
1.20 meters. Pre-Analysis Room/s should have direct access to service
corridor.
____2.3.4. Door access from service corridor have at
least 1.00 meter clear width to
accommodate entry and exit of equipment as
applicable.
___2.3.5. Internal windows are laid out to promote visual observation between work
rooms as
applicable.
____2.3.6. Provision for
toilet and other amenities for laboratory staff are located
outside the main laboratory but easily accessible to prevent contamination.
___2.3.7. Presence of Perimeter fence / well-secured location within the building.
___2.4. Conforms to
the applicable codes as part of normal professional practice.
____2.2.1. Exits restricted to the following types: door leading directly outside of the
building, interior stair, ramp, and exterior stair.
____2.2.2.. Minimum of two (2) exits as remote as possible from each other.
___2.2.3. Exits terminate directly at an open space to
the outside of the building.

3. MECHANICAL PLAN
____3.1. The pre-analysis room/s for specimen receiving and specimen handling/ sample
preparation shall have a negative pressure room conditioned and its exhaust must

____3.2.
produce
The
at
least 12 air changes per hour (ach).
analysis room shall have a negative pressure room conditioned and its exhaust must
at
produce least 6 ach.
___3.3, The reagent preparation room shall have a positive pressure room conditioned. Also,
shall have filtered air supply with a 90-95% efficiency.
it
____3.4. The exhaust stack shall be at least 3 meters above the highest point of
the roof or 3 meters
above the highest point of the roof of the adjacent building, whichever is
stringent, and
should be distant to other taller structures with open windows above. The exhaust stack
shall be oriented in an up-blast orientation and discharge shall be directed vertically
upward without having a gooseneck, elbow, cap or cover.
3.5. Additional exhaust requirements must be installed (e.g. bag-in bag-out (bibo) high
efficiency particulate air (HEPA) filter box) if the above criterion was not met, and if
the location of the laboratory may still impose rist to the surrounding (if
applicable).
oH 4} DOH-HFSRB-QOP01-Covid19TL NCBT-PTC-CR
Revision: 00
Ol/2peee, 4023
Page
2 of
 ___3.6. Supply intake location must at least 7.62 meters (25 ft.) from the exhaust stack and in
opposite direction.
___3.7. Exhaust air in
grille locations must be
of the biosafety cabinet.
the
dirty side of the laboratory preferably on top
Supply air grille locations were on the clean side of the laboratory preferably near
___ 3.8. entrance doors.
___3.9. All air conditioning units must be split type.
___3.10. Air direction should be away from the biosafety cabinets, and other containment
equipment.
3.11. Under no circumstances should the exhaust air from the specimen receiving and
____
specimen handling/sample preparation rooms be recirculated to other areas.

COMMENTS:

OOH-HFSRB-QOP01-Covid19TL NCBT-PTC-CR
Revision: 00
1/20: 4oas
Page
3 of
 Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name
of Health Facility:
Address:
Date:

COMMENTS:

HEALTH FACILITIES EVALUATION AND REVIEW COMMITTEE (HFERC)

[ ] Approved [ ] Disapproved

Chairperson, HFERC

Vice-Chairperson, HFERC

Member Member Member

Member Member Member

cal 4
DOH-HFSRB-QOP01-Covid19TL NCBT-PTC-CR

eee
ion: 00
Rati dots
el
A.O. NO. = 7093 = - pond
=

ANNEX F1

6700
4 4

so z =

rs r
=
=x Lah! AN
5)'@ ‘rH!
|
@
41) 5 7
—— 3

3 3Fo
s PROCESSING ROOM
is i
i
pre-analysis analysis
1
@ i} area area '@

sg Naa)!
H? aa
149) |

@®
v ao
1

7
ZS

i)42)
\
nll 6
; a
®
"SPECIMEN
RECEIVING
DONNING
1 7

CLEA
s
5
S| DDFFING
3) 8) JAREA S
\
aNTRY,

i) ENTRY)
>
|

ox
1§
¥ =
— -
——

1600 1500 1900 1700

| \ '

k +— + ¢ }
6700
¢ +

NOTES: LEGEND:

- THIS SAMPLE FLOOR PLAN IS ONLY FOR COVID-19 TESTING 1 AUTOCLAVE

LABORATORY USING CARTRIDGE-PLATFORM INDETECTING 2. POLYMERASE CHAIN REACTION (PCR) MACHINE
SARS-COV-2 (E.G. GENEXPERT). 3. BIOLOGICAL SAFETY CABINET (BSC)
4. VORTEX MIXER
- THE PROPOSED COVID-19 TESTING LABORATORY SHOULD BE 5. MICRO CENTRIFUGE
LOCATEDIN A SEPARATE LOCATION/ OUTSIDE AN EXISTING 6. FREEZER
INSTITUTION WHERE THERE
PROTECTION OF STAFF AND PUBLIC.
IS
LESS FOOT TRAFFIC FOR THE 7.

8.
REFRIGERATOR
FIRST AID KIT
9. SPILL KIT
- OTHER SUPPORT SERVICES AREAS, WASTE HOLDING AREAS, 10. PERSONAL PROTECTIVE EQUIPMENT (PPE) & PPE CABINET
TOILET, SPECIMEN COLLECTION AREA, AND STAFF AMENITIES 11. LABORATORY DEEP SINK WITH EYE WASH
CAN BE LOCATED IN
A SEPARATE AND EXISTING ADJACENT 12. HAND WASHING SINK WITH EYE WASH
STRUCTURE. 13. COMPUTER
14. PASS BOX
15. WASTE BIN
16. PPEHAMPER

GRAPHICAL SCALE:
0050 4
2 3 4

me
, DEPARTMENT OF
)
HEALTH
TITLE / SHEET CONTENT:

SAMPLE FLOOR PLAN FOR

APPROVED BY: SHEET NO. 1
0.1
REVISION
Gi domoep
OF 1

P23
“)

CENTRAL OFFICE CARTRIDGE-BASED COVID-19 ATTY

NICOLAS B, LUTERO ll,
CESO II
REPAREDEY!
SERB ica a kee TESTING LABORATORY
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU HFSRB-SDD

ah |
 A.O. NO. ~ 2023 - 0004
ANNEX F2
10100
k +
} 3100
' 3300
4
2400
‘
1300
t

— =
|

Py r -

] TT
On
OHO)
1
DN® 8) Ge lenta
|
7

® @|

*
L
4

z
]

ANTEROOM SERVICE AREA gs

» >
|

EXT

i
(utilities, waste, etc.
|

| ]
specimen (for doffing) Ss
|
| '

handling area
|

I
D
|

16
———
art
Was
|
A
yy 4
18:
=

.ee
a
< L
l (2!)
ANALYSIS
ROOM
=
8
oN template |
eezsnen PRE-ANALYSIS
8
Ml
“|

adding area
a.

receiving area ROOM

= SI}
3 0 @

2 = 1 4 a~

a
| @ |
|
;

=
8
a
K
7 1s 8
= —= = !

ald
dt}
k REAGENT.
{art
H

B REPARATION
3

|
fi
u
6 ROOM

ig SPECIMEN ANTEROOM—] | ANTEROON

|S RECEIVING CLEAN WRITESHOP (for donning) ag]
|

@ (ce
lev
:
AND SUPPLY ROOM
|

2) s
¥~
|

iat Ty
v _— ;
1 7

|
ENTRY
ENTRY/ !
ENTRY/
EXIT EXIT
8 c R |R + D |O R

_
'

\
|
|

MAIN ' f
= '
L
|

ENTRANCE |
|
|

1600 L 3000 L
10100
1800
k
2400
} 1300)
} +

NOTES: LEGEND:

- THIS SAMPLE FLOOR PLAN ONLY FOR

NON-CARTIDGE-BASED COVID-19 TESTING LABORATORY
IS 1.
2.
AUTOCLAVE
REAL TIME POLYMERASE CHAIN REACTION (RT-PCR) MACHINE
PERFORMING MANUAL RNA EXTRACTION rRT-PCR. 3. BIOLOGICAL SAFETY CABINET (BSC)
4. PCR CABINET
- THE PROPOSED COVID-19 TESTING LABORATORY SHOULD BE 5. VORTEX MIXER
LOCATED IN
A SEPARATE LOCATION/ OUTSIDE AN EXISTING 6. MICRO CENTRIFUGE
INSTITUTION WHERE THERE LESS FOOT TRAFFIC FOR THE
PROTECTION OF STAFF AND PUBLIC.
IS 7. MINI CENTRIFUGE
8. PIPETTES & PIPETTE FILTERED TIPS
9. FREEZER
- OTHER SUPPORT SERVICES AREAS, TOILET, SPECIMEN 10. REFRIGERATOR
COLLECTION AREA, AND OTHER STAFF AMENITIES CAN BE 11. FIRST AID KIT
LOCATED IN
A SEPARATE AND EXISTING ADJACENT 12. SPILL KIT
STRUCTURE. 13. PERSONAL PROTECTIVE EQUIPMENT (PPE) & PPE CABINET
14. LABORATORY DEEP SINK WITH EYE WASH
15. HAND WASHING SINK WITH EYE WASH
16. STAINLESS STEEL UTILITY SINK
17. COMPUTER
18. PASS BOX

SS
19. WASTE BIN
20. PPE HAMPER

GRAPHICAL SCALE:
° 0.50 1 2 3 4

Sa

ae
Republic ofthe Phiippines
TITLE / SHEET CONTENT: APPROVED SoBY: SHEET NO. 1 OF 1

DEPARTMENT OF REVI
ION 0.1

Ceres NON-CARTRIDGE BASED COVID-19

B, Ill,
Ee
CESO Il
PED
ATTY. NICOLAS LUTERO
CENTS CFEC
E 4 -
DIRECTOR IV, ey |
TESTING LABORATORY
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU HFSRB-SDD

7q
 AD- No. 2023 - 0d04
;
Annex G

Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

June 28, 2021

DEPARTMENT CIRCULAR
No. 2021 -
0495

FOR : DIRECTORS OF CENTERS FOR HEALTH DEVELOPMENT

(CHD); DIVISION CHIEFS OF CHD REGULATIONS,
LICENSING AND ENFORCEMENT DIVISION (RLED) AND
HEALTH FACILITIES AND SERVICES REGULATORY
BUREAU; MINISTER OF HEALTH-BANGSAMORO
AUTONOMOUS REGION _IN MUSLIM MINDANAO (MOH-
BARMM); REGULATORY OFFICERS: HEAD OF COVID-19
TESTING LABORATORIES; AND ALL OTHERS CONCERNED

SUBJECT :
Advisory on the Regulation on Innovations in the RT-PCR Plate
Based Diagnostic Platform for COVID-19

Pursuant to Department Memorandum (DM) No. 2020-0512, “Revised Omnibus Interim Guidelines
on Prevention, Detection, Isolation, Treatment, and Reintegration Strategies for COVID-19” issued on
November 26, 2020, the Department of Health (DOH) continues to intensify the strategies for the
screening and surveillance testing as part of COVID-19 response. Part of the innovative strategies
identified and employed were pooled testing and use
of
saliva as a specimen for COVID-19 Reverse
Transcriptase-Polymerase Chain Reaction (RT-PCR)
available resources.
to
efficiently identify cases and maximize the

In support of these innovations, DOH released DM No. 2020-0539 titled “Interim Guidelines
on the
Conduct of COVID-19 Pooled Testing” dated November 23, 2020, and its amendment issued on May
17, 2021, and DM No. 2021-0161 titled ‘Interim Guidelines for the Conduct Saliva-Based RT-PCR
Testing for the Detection of SARS-COV-2” dated March 31, 2021, to guide DOH licensed COVID-19
of
laboratories on the use of these innovations in the RT-PCR plate based diagnostic platform for COVID-
19,

This Circular is being issued to reiterate the guidelines in the above-mentioned DMs and as a
guide in
the regulation of these innovative services:
|. The nasopharyngeal and/or oropharyngeal swabs (NPS/OPS) shall remain the specimen of
choice for COVID-19 PCR testing.

2. Only DOH licensed plate-based RT-PCR COVID-19 testing laboratory shall be allowed to
conduct these innovations in the diagnostic platform (i.e., pooled testing and use of saliva as
specimen for RT-PCR testing) as add-on services, once recommended by Health Technology the
Assessment Council (HTAC). The relevant procedures for each of the innovations in the
diagnostic platform shall be included in their Manual of Operations. ty)

Building 1,

ae Bn ae LPEDTIFIED
NTT
San Lazare Compound, Rizal Avenue, Sta. Cruz, 1003 Manila @ ‘Trunk Line 651-7800 local] Motel
Direct Line: 711-9502: 711-9503 Fax: 743-1829 @ URL: htip:/Avww doh gov.ph: e-mail: Aduqded doh.gov.ph

JUL 06)
4 hy
43
RUE COPY

2021

MARIA CRIBTINA P. RIVERA

KMITS SRECQBBS SECT!
Department of Health
 3. These RT-PCR COVID-19 testing laboratories shall first be certified by the Research Institute
for Tropical Medicine (RITM) to
perform the innovations in
the plate based diagnostic platform
prior application
to for the add-on service.
4. Theverification protocol for pooled testing and the
verification protocol for saliva as alternative
specimen, which are both set by RITM for RT-PCR, shall be strictly followed.

5. All COVID-19 test kits to be used must be authorized by FDA for such specific use, such as use
of saliva as specimen, and validated by RITM or other RITM-authorized institutions.
6. For pooled testing, only FDA authorized RT-PCR kits already validated by RITM or
authorized institutions and have satisfied the 95% clinical sensitivity and 99% clinical specificity
its
as recommended by the World Health Organization shall be used.

7. The personnel of the COVID-19 testing laboratory who will perform the innovations the platein
based diagnostic platform shall undergo the corresponding training for such procedures.

8. A full line list of negative and positive specimens shall be reported through the COVID-19
Repository Document System (CDRS).

9. Monitoring may be done by the Health Facilities and Service Regulatory Bureau
(HFSRB)/Center for Health Development-Regulatory, Licensing and Enforcement Division
(CHD-RLED).

10. All COVID-19 laboratories offering these innovations in the diagnostic platform shall
participate in the Quality Assurance Program provided by RITM. The RITM furnish the will
HFSRB/CHD-RLED its findings and recommendations.

11. All DOH licensed COVID-19 testing laboratories

shall have policies and procedures for waste
management in accordance with the DOH Healthcare Waste Manual.

12. All DOH licensed COVID-19 testing laboratories shall strictly follow the current and upcoming
guidelines set by the DOH and RITM on
the innovations in the RT-PCR plate based diagnostic
platforms.

13. All DOH licensed COVID-19 testing laboratories shall strictly adhere to the standards and
requirements set forth in AO No. 2020-0014 “Guidelines in Securing a License to Operate
COVID-19 Testing Laboratory in the Philippines,” its amendments and assessment tool at all
times.

For dissemination.

as
By Authority of tWe-Sgcretary of Health:
bie raa cae
CERTIFIED TRUE COPY
|

GERARDO VY BAYUGO, MD, MPH, CESOT

06 72021

“ined Undersecretary of Health

MAR CROROS SECTION

enon’
,
é
Health Regulation
2 Team
ee ,
i Department of Health
UY
&
)
 Attachment

Additional Requirements for the Conduct of the Innovations

in the RT-PCR Plate Based Diagnostic Platform for COVID-19

A. Pooled Testing
1. The indication for Pooled Testing shall follow eligibility criteria specified in Section
III. Specific Guidelines of DM 2020-0539 and its amendment.

2. The personnel for pooled testing are required to attend documentation and sample
pooling strategies provided by the Philippine Society of Pathologists through the
Philippine Children’s Medical Center for pooled testing.

3. The recommended maximum number of samples for pooled testing is up to five (5).

B. Saliva as Specimen for COVID-19 Testing

1. The indication for saliva as specimen shall follow the DOH guidelines and RITM’s
“Standard Method for Verification of Saliva as Alternative Specimen for SARS-COV-
2 Real Time PCR Testing: Interim Guidance for Laboratories in the COVID-19
Laboratory Network” dated February 7, 2021.

There should be policies and procedures on saliva collection to ensure the quality of the

oe
2.
sample. A laboratory staff shall oversee the saliva collection activity.