Republicof the Philippines

Department of Health
OFFICE OF THE SECRETARY
NOV 19 2023

ADMINISTRATIVE ORDER
No. 20230018
-__

SUBJECT : Guidelines on the Licensing of Clinical Laboratory for

Molecular Pathology

I. RATIONALE

Molecular diagnostics had a remarkable expansion and advancement over time and
made significant contributions to the study and treatment of diseases, medical diagnosis,
and the promotion of general health. Some of the diverse medical fields that utilize
molecular diagnostics include infectious diseases, genetics, pharmacogenomics, and
oncology, enabling the detection of disease-causing genes to predict, prevent, and manage
certain diseases. Highly sensitive molecular techniques such as Polymerase Chain Reaction
(PCR) and Fluorescent In-Situ Hybridization (FISH) are the most commonly available tests
in the country, allowing gene detection even if they may be present in minute quantities.

Administrative Order (AO) No. 2021-0037, entitled “New Rules and Regulations
Governing the Regulation of Clinical Laboratories in
the Philippines,” classified Molecular
Pathology as one of the function and service capability of a clinical laboratory. Molecular
pathology, similar to other sections and services of the clinical laboratory, shall ensure
accurate and reliable diagnostic results at all times.

Upon careful examination, certain policy gaps have been identified that may
potentially impact the establishment and operation of a Clinical Laboratory for Molecular
Pathology. Proactively addressing these gaps is essential to ensure the effective
implementation of the regulation and the successful functioning of these facilities.

Thus, this Order is being issued to supplement and provide the licensing standards
and requirements for the regulation of Clinical Laboratory for Molecular Pathology.

IL OBJECTIVE

This Order aims to provide guidelines in the regulation of diagnostic Clinical

Laboratories for Molecular Pathology in the Philippines, whether private or government-
owned, to ensure accountability in the generation of accurate and precise results, whilst
safeguarding public safety.

I. SCOPE OF APPLICATION

This Order shall apply to all clinical laboratories in the Philippines offering
molecular diagnostics tests.

In case of Bangsamoro Autonomous Region in Muslim Mindanao (BARMM), the

adoption of this Order shall be in accordance with the Bangsamoro Organic Act (Republic
Act No. 11054) and subsequent laws and issuances.

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Iv. DEFINITION OF TERMS

A. Biorisk Assessment — refers to the process to identify acceptable and unacceptable risks
(embracing biosafety risks: risks of accidental infection, and laboratory biosecurity
risks: risks of unauthorized access, loss, theft, misuse, diversion or intentional release)
and their potential consequences (WHO, 2006).

B. Clinical Laboratory (CL) ~ refers to a facility that is involved in the (a) pre-analytical,
(b) analytical, (c) and post-analytical procedures, where tests are done on specimens
from the human body
to obtain information about the health status of a patient for the
prevention, diagnosis and treatment of diseases. These tests include, but are not limited
to, the following disciplines: anatomic pathology, clinical chemistry, clinical
microscopy, endocrinology, hematology, immunology and serology, microbiology,
toxicology, as well as molecular and nuclear diagnostics (AO No. 2021-0037).

C. Clinica] Laboratory for Molecular Pathology — refers to a CL that provides analysis

ofcertain genes, proteins and other molecules in samples from organs, tissues or bodily
fluids in order to diagnose disease and/or to guide the prevention and treatment of
disease based on the principles, techniques and tools of molecular biology as they are
applied to diagnostic medicine in the laboratory (AO No. 2021-0037).

D. 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
treatment, and surveillance
to obtain information
protocols for COVID-19
for
(AO
the prevention, diagnosis and
No. 2023-0004).

E. Outsourcing — refers to sent-out molecular tests that are not performed in the DOH-
licensed CL for Molecular Pathology. It may be done upon the request of the attending
physician.

GENERAL GUIDELINES

A. Allclinical laboratories performing molecular diagnostic tests, including but not limited
to Nucleic Acid Amplification Tests, genome sequencing, clinical cytogenetics tests,
and other related tests, shall apply fora DOH-LTO for CL for Moiecular Pathology. See
Annex A for the Process Flow.

B. Existing DOH-licensed clinical laboratories that intend to apply for CL for Molecular
Pathology (except for SARS-CoV-2) shall file an application for additional (add-on)
service.

C. Existing DOH-licensed non-institution-based COVID-19 TL that intend to expand their

molecular diagnostics tests beyond SARS-CoV-2 shall apply for a separate License to
Operate (LTO) for CL for Molecular Pathology and may co-share physical plant,
equipment, and personnel; provided that biorisk assessment is performed and
appropriate schedule of tests is in place in accordance with the facility’s standard
operating procedures.

D. All CL for Molecular Pathology that

intends to offer COVID-19 tests
shall comply with
the AO No. 2023-0004 titled
“New Rules and Regulations Governing the Licensure of

HY
 COVID-19 Testing Laboratories Performing Nucleic Acid Amplification Test (NAAT)”
and secure a separate DOH-LTO as COVID-19 testing laboratory. It may co-share
physical plant, equipment, and personnel. Appropriate biorisk assessment and
scheduling of tests shall also be conducted and followed.

E. The CL for Molecular Pathology shall formulate its manual of operations, which shall!
be strictly enforced and implemented in the CL.

F. All CL for Molecular Pathology shall submit the scope of services and/or list of tests to
be performed within the facility upon application, including the gene/pathogen to be
identified.

G. A valid Memorandum of Agreement (MOA) or its equivalent, prescribing the

accountabilities of each party shall be required for outsourced molecular diagnostic tests.
All official results shal] be issued by the CL that performed the test/s.

H. Confirmatory tests for emerging and re-emerging diseases of public health concern (e.g.,
Monkeypox) as declared by the national government shall only be performed National
Reference Laboratories (NRL), NRL-recognized clinical laboratories, and/or selected
in
laboratories designated or approved by DOH, as
applicable.

I. All results for molecular tests related to pathogens causing notifiable diseases, especially
genomic sequencing, shall be reported to the Department of Health in line with Republic
Act No. 11332 also known as “Mandatory Reporting of Notifiable Diseases and Health
Events of Public Health Concern Act” and its Implementing Rules and Regulations.

J. The CL for Molecular Pathology shall comply with the standards and requirements
reflected herein, Annex B — Assessment Tool for Licensing Clinical Laboratory for
Molecular Pathology, and Annex C — Checklist for Review of Floor Plans or Annex D
— Checklist for Review of Floor Plans (performing hybridization, clinical cytogenetics

tests, cartridge-based technology), and other related laws and DOH issuances, primarily
AO No. 2021-0037, titled “New Rules and Regulations Governing the Regulation of
Clinical Laboratories in the Philippines.” Likewise, prohibited acts, violations, and
penalties shall be enforced as stated in the aforementioned AO.

VI. SPECIFIC GUIDELINES

A. Classification of the CL as to ownership, institutional character, and function shall
follow AO No. 2021-0037.

B. Physical Plant

1. Appropriate workflow shall be monitored, maintained, and followed

the staff, specimen/samples, reagents, and wastes.
at all times for
2. There shall be controlled, maintained and adequate ventilation within the CL for
Molecular Pathology.

3. There shall be an infection, prevention, control, maintenance, and biosafety risk

management program in the CL for Molecular Pathology. Biosafety risk assessment
shall be conducted regularly as determined by the designated Biosafety and
Biosecurity Officer.

3
44
C. Personnel

—
1. There shall be adequate, qualified, and trained personnel in the CL for Molecular
Pathology.

2. The personnel requirement may be co-shared with the DOH-licensed CL and/or

COVID-19 TL, provided that the following qualifications, training, and staffing
requirements are met:
Staffing Qualification Training Staffing Pattern
Requirement
Head of Laboratory |e Board-Certified 1. Molecular « If CP only -
with
{HOL) Pathologist Diagnostic associate AP as
© Clinical Techniques minimum for those
Pathologist (CP), 2 Biosafety’ with anatomic
OR Biosecurity/ Biorisk assessment (ie,
Management malignancies,
+ Anatomic
genetics etc)
Pathologist, OR
« Combined
Anatomic and
Clinical
Pathologist
(AP/CP)
Analysts ¢ Medical Technologist, 1. Molecular diagnostic « Three GB)

AND techniques either analysts/shift

* Registered Medical from: co All analysts per
Technician, AND/OR * DOH
recognized shift shail be
© Allied professionals or DOH trained in
may be allowed designated molecular
provided that they have training provider diagnostics
a bachelor’s degree o At least one (1)
* Manufacturer or
relevant to the job with
supplier of the per shift shall be
knowledge, aechin ef trained in
experience, and skills
in molecular methods
equipment to
used by the CL
be Biosafety/
Biosecurity/
and principles, such as Biorisk
for Molecular
Molecular Biology, Patholo
Management
a ey
Microbiology,
Biotechnology,
»*
In-house from a
Biology, Biochemistry, formally trained
Genetics, Chemistry analyst from
DOH or DOH

eee
recognized

2, Bionten °
per cartridge-based
PCR — At least
Biosecurity/ Biorisk one
(1) RMT per shift
Management from
trained in molecular
DOH
(RITM-Biorisk di ti
sties an d
Management Office) biceate
d
osatety an
or DOH recognized
biosecurity
training provider
*For DOH-program
based using
GeneXpert or other
eartridge-based
equipment - One (1)
RMT may handle
more than I DOH-
program based
facility within their
healthcare provider
network
Support Staff ¢ At least vocational 1. In-house training on At least one (1) per
« Encoders course graduate biosafety and shift
and/or biosecurity
Receptionists
Note:
1, An increase in workload may correspond
to additional personnel as recommended by the HOL

‘4/4
2. At least one reliever
 D. Equipment/Instrument/Reagents/Supplies

1. The CL for Molecular Pathology shall have adequate equipment, instruments,

reagents, and supplies which are all in good working condition, functional, and
sufficient for the operations.

The CL for Molecular Pathology shall have a contingency plan in case of emergency
such as machine malfunction/equipment breakdown, unavailability of supplies and
reagents in the market, laboratory contamination, and the like. They may accept
samples for testing for referral to other DOH-licensed CL for Molecular Pathology.

All assays to be used for diagnostic testing shall be verified in-house in the actual
laboratory set-up prior to use. The results of the performance evaluation shall be
properly documented.

The CL shall strictly observe the use of personal protective equipment and adhere to
biosafety, biosecurity, infection prevention and control, and environmental
guidelines and policies.

E. Information Management
1. There shall be procedures for the provision of laboratory services, reporting of
workload, management review, quality control, inventory control, reporting and
analysis of incidents and adverse events, handling complaints, and other related
processes.

All official results shall be signed by the head of laboratory or an associate

pathologist, and medical technologists as analysts.

The
use of electronic signature/s shall be permitted in accordance with the provisions
of the E-Commerce Law. The CL for Molecular Pathology shall have a policy
guideline on the use of electronic signature.

F, Quality Improvement

1. The CL for Molecular Pathology shall implement an internal quality assurance

program for technical procedures, risk management plan, and other continuous
quality improvement programs covering all
aspects of laboratory performance.

External Quality Assessment Program (EQAP) participation or its equivalent is

recommended and not yet required, upon the DOH designation or recognition of
EQAP provider for molecular diagnostics.

VII. PROCEDURAL GUIDELINES

A. DOH- Permit to Construct (DOH-PTC)

1, A DOH-PTC shall
be required for the construction of a new CL for Molecular
Pathology (initial), existing DOH-licensed CL, and existing DOH-licensed COVID-
19 testing laboratory with substantial alteration, renovation or expansion, transfer of
location, or change of ownership.

4%
4
 Sat
2. A duly accomplished PTC application form (downloadable at

hee
https://hfsrb.doh.gov.ph/) shall be submitted to the Health Facilities and Services

3.
elhepaAI, Bran iin JF
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.

B. DOH-License to Operate (DOH-LTO)

1. All DOH-LTO applications for CL for Molecular Pathology, whether initial,

renewal, or add-on service, shall be submitted to the HFSRB/Center for Health
Development-Regulation, Licensing and Enforcement Division (CHD-RLED), in
accordance with the current DOH guidelines.

2. The processing of DOH-LTO application to issuance shall follow the Quality

Management System (QMS) guidelines of the HFSRB/CHD-RLED and the
Citizen’s Charter.

3. Filing of Application
a, Initial Application
The facility shall then submit the notarized
completely filled-out application
Form 1 (downloadable
plus the following:
at https://hfsrb.doh.gov.ph/) with its required documents

i. List of tests/services to be performed within the CL.

ii.
iii,
if
Lists of test/s to be outsourced, applicable.
MOA with the DOH-licensed CL (or its equivalent for overseas)
prescribing the accountabilities of each party,
b. Renewal Application
if applicable.

The facility shall submit the notarized completely

filled-out application Form 1
(downloadable
i.
at https://hfsrb.doh.gov.ph/) with its required documents plus:
Proof of EQAP participation, when available
c. Additional (Add-On) Service
Duly accomplished application Form 2 (downloadable at
https://hfsrb.doh.gov.ph/) shall be submitted to HFSRB for add-on service, plus
the following documents:
i. List of tests/services to be performed within the CL.
ii.
iii,
if
Lists of test/s to be outsourced, applicable.
MOA with the DOH-licensed CL (or its equivalent for overseas)
prescribing the accountabilities of each party, if applicable.

4. DOH-LTO shail be valid until December 31 of the current calendar year.

C. Inspection

1. Inspection and monitoring shall be done by the HFSRB/CHD-RLED utilizing the

Annex B — Assessment Tool for Licensing Clinical Laboratory for Molecular
Pathology of this Order.

2. The process for inspection shall follow Section VI. E of AO No. 2012-0012: “Rules
and Regulations Governing the New Classification of Hospitals and Other Health
Facilities in the Philippines” and the QMS guidelines of the HFSRB/CHD-RLED.

1Y
 D. Monitoring

1. Authorized representatives of the HFSRB/CHD-RLED may conduct unannounced

on-site visits to monitor and document the continuous compliance of the CL to the
set standards, and that they are not operating beyond their list of service capabilities.

2. The process for monitoring shall follow Section VI. F of AO No. 2012-0012: “Rules
and Regulations Governing the New Classification of Hospitals and Other Health
Facilities in the Philippines” and the QMS guidelines of HFSRB/CHD-RLED.

E. Fees

1. The fee/s shall follow the schedule of fees currently prescribed by the DOH. The
Order of Payment may be accessed athttps://hfsrb.doh.gov.ph/.

2. The applicant, upon filing the application, shall pay the corresponding fee to the
DOH Cashier/online payment through Landbank (once available).

VIIl. ROLES AND RESPONSIBILITIES

The roles and responsibilities of the HFSRB, CHD-RLED, NRL, and DOH-licensed
CL
shall be based on AO No. 2021-0037.

IX. PENAL PROVISIONS

Imposable penalties and sanctions for prohibited acts and violations shall be
enforced in accordance with this guideline, Annex C of AO No. 2021-0037, titled “New
Rules and Regulations Governing the Regulation of Clinical Laboratories in the
Philippines,” and other related laws and DOH issuances.

TRANSITORY PROVISION

A. Registered Special Clinical Laboratories prior to the issuance of this Order and AO No.
2021-0037 shall be reclassified accordingly (e.g., CL for Molecular Pathology, Stem
Cell Facility), and shall follow the standards set
for them.

All molecular diagnostics laboratories operating prior to the effectivity of this AO shall
be required to secure a DOH-PTC prior to
application for DOH-LTO and shall be given
a grace period to comply with the physical plant requirements until October 1, 2026.

All Clinical Laboratory for Molecular Pathology shall be given a grace period to comply
with the ventilation requirements until October 1, 2026.

All existing DOH-program based CL offering molecular diagnostics shall be licensed

accordingly and shall be given until October 1, 2026, to fully comply with the
requirements, provided that the CL is identified or recognized as such by the DOH.

44
XI. APPEAL

Any CL for Molecular Pathology or any of its personnel not amenable with the
decision of the DOH-HFSRB may filea notice of appeal to the Head of the Health Facility
and Patient Support Team (HFPST) 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 to the HFPST. The decision of the Head of the HFPST, if still contested, may
be brought on a final appeal to the Secretary of Health, whose decision shall be final and
executory.

XII. REPEALING CLAUSE

Administrative Order No. 2007-0027 on the “Revised Rules and Regulations

Governing the Licensure and Regulation of Clinical Laboratories in the Philippines,” and
other related issuances inconsistent or contrary to the provisions of this Administrative
Order are hereby repealed, amended, or modified accordingly.

xI. SEPARABILITY CLAUSE

If any part or provision of this Order is rendered invalid by any court of law or
competent authority, the remaining parts or provisions not affected shall remain valid and
effective.

XIV. EFFECTIVITY

This Order shall take effect fifteen (15) days from the date ofits publication in any
national newspaper of general circulation, with three (3) certified copies to be filed with the
Office of the National Administrative Register (ONAR)
Law Center.
of the University of the Philippines
 AO No. 2023 -_0018
ANNEX A
Republic of the Philippines
Department of
Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

PROCESS FLOW INITIAL LICENSING OF CLINICAL LABORATORY FOR

—
FOR

MOLECULAR PATHOLOGY
1. New applicants! — Clinical Laboratory for
Molecular Pathology Only
nN
Existing DOH-licensed clinical
laboratories! that will apply CL for
Molecular Pathology
as additional service

t
STEP 1. Apply for DOH-Permit to Construct (DOH-PTC) at HFSRB and
processing in accordance with Citizen’s Charter. Application Form
available at https://hfsrb.doh.gov.ph/

Existing DOH-
licensed COVID-19
testing laboratories with
no substantial alteration,
STEP 2. Apply for DOH-License to Operate (DOH-LTO) in
accordance
with Citizen’s Charter - Application Form at https://hfsrb.doh.gov.ph/
|ayJ
expansion, renovation, to be submitted to HFSRB
transfer of site, or change
in ownership and intend t
to co-share physical plant STEP
3. Evaluators shall assess the technical completeness and correctness
of the submitted documentary requirements.

y
STEP 4. Order of Payment shall be issued for technically correct and
complete documents.
v
STEP 5. HFSRB shall conduct inspection of the health facility

STOP-CLOCK shall be observed for

Fully HFSRB, and the laboratory shall submit
compliant
NO proof of compliance within 30 calendar days
YES ¥
Proceed uD Step 6
STEP 6. Recommend issuance of LTO
once complied
v
STEP 7. Approval and signing of
DOH-LTO In the event that the
applicant cannot
comply within the
given period, the
License to Operate (initial) Updated License to Operate application shall be
(additional service) automatically denied,
-—
and the payment shall

STEP
8. Recording and releasing of the approved and signed DOH-LTO

a)
'
for DOH-License to Operate for CL for Molecular Pathology only
New applicants or
as an additional service to
an existing DOH-Licensed CL shall start at Step 1
 AO No. 2023 -_0018
ANNEX B
Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

ASSESSMENT TOOL FOR LICENSING

CLINICAL LABORATORY FOR MOLECULAR PATHOLOGY

INSTRUCTIONS:
1. To properly fill-out this tool, the Licensing Officer shall make use of: INTERVIEWS, REVIEW OF
DOCUMENTS, OBSERVATIONS and
VALIDATION of
findings.
2. Ifthe corresponding items are present, available or adequate, place a (V) 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.
4, Make sure to fill-in the blanks with the needed information. Do not leave any items blank. Put N/A if Not
Applicable.
5. The Team Leader shall ensure that all team members write down their printed names, designation and affix their
signatures and indicate the date of inspection/monitoring, all at the last page 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.

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
Number:
DateIssued: ——C—~—“‘C‘éE pry Date:
Name of Owner or Governing
corporation):
Body (if

Name ofHead of
Laboratory:

ao

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 CRITERIA INDICATOR/EVIDENCE COMPLIED REMARKS
I. ORGANIZATION AND MANAGEMENT
The organization's management team provides leadership acts according to the organization's policies and has overall
responsibility in ensuring effective and efficient operation of the organization (clinical laboratory).
1. There is an Observe
organizational Updated organizational structure and/or chart
structure that clearly is posted or displayed in conspicuous area
reflects the line of with the names, latest pictures (at least
authorities, passport size) and designation
accountability,
communication,
interrelationship,
hierarchy of functions
and flow of referrals
2. The organization’s Document Review
mission, vision, and Written vision, mission, and goals
goals are in accordance
with Republic Act Observe
(RA) No. 4688 Vision, mission, and goals posted or displayed
in a conspicuous area visible to clients
3. The organization has a Document Review
valid DOH- LTO and Valid DOH-LTO with service capability
other pertinent indicated, if any
documents e Copy of clinical laboratory (CL)
Administrative Order (AO) (hard or soft
copy) and related issuances

Observe
e¢ Valid DOH-LTO posted
visible to clients
ina conspicuous area

e The list of services and operating hours is

known toits clients
4. The organization Document Review
documents and] e Compiled documented minutes of meeting
follows the policies reflecting the date, time, attendance, agenda,
and procedures of and action taken signed and approved by Head
monitoring and of Laboratory (HOL), held at least twice a
evaluation of year or as needed and other relevant
activities including documents pertaining to evaluation and
management review monitoring of activities
Documented reports of inspection and/or
monitoring
Documented records of client feedback and/or
complaints received and analysis of client
feedback, complaints and corrective actions
taken

Observe
Client feedback form and/or suggestion box
available for clients
II. HUMAN RESOUR CE MANAGEMENT
There is an adequate number of trained personnel, and workload is monitored appropriate to guidelines to provide safe,
effective and efficient services toclients.
5. There are policies and Document Review
procedures for Written policies/procedures_ or related
screening, hiring, documents for screening and hiring process,
orientation, orientation, designation, and promotion of
designation, personnel at all levels
\ _training/retraining and Proof ofconducted personnel orientation

DOH-HFSRB-QOP-01-CLMP-AT-Annex B
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Page 2 of 11
 CRITERIA INDICATOR/EVIDENCE COMPLIED REMARKS
promotion for all
levels of personnel
.s
he: organization Document Review
documents and follows e Written policies/procedures for staff
policies and development and training
procedures on} e Annual plan and/or proposed schedule of
continuing program training activities
for staff development
and training Interview
e Human Resources Management

—_
Officer/Administrative Personnel
Officer/Registered Medical Technologist
Supervisor/Training Officer/ Head of
Laboratory
. There are policies and Document Review
procedures for| e Written policies/procedures on discipline,
discipline, suspension, suspension, demotion and termination of
demotion, and personnel at all levels
termination of} ¢ Documented proof of corrective actions
personnel at all levels taken, as applicable.
. Compliance to the Document Review
implementation of] e Proof of submission of data to NDHRHIS,
National Database of updated regularly as necessary
Human Resource for
Health Information
System (NDHRHIS)
. Each personnel shall Document Review
have a record of] e Updated personnel/employee 201 files of all
updated CL
personnel
personnel/employee
201 files with
documented training
and experience to
conduct/perform the
laboratory procedures
a. Head of ¢ of
Proof qualifications:
Laboratory * Updated Resume/Personnel Data Sheet
(HOL) * Valid PRC ID
* PSP Board Certificate
* Notarized employment contract
*
Training certificates in Molecular
Pathology/Molecular Diagnostic methods
and principles
*
Training on Biosafety/ Biosecurity/
Biorisk Management
* Annual Health Status or latest Medical
Certificate
* Vaccination record or immunization status
(i.e., Hepatitis B)
b. Registered
Medical
e Proofof qualifications:
*
Updated Resume/ Personnel Data Sheet
Technologist * Valid PRC ID
(RMT)/Analyst * Notarized employment contract
¢ Training certificates in Molecular
Diagnostic methods and principles
* Training on Biosafety/Biosecurity, and
Biorisk Management (if different from
the designated Biosafety Officer)
+ Annual Health Status or latest Medical
Certificate
Bf
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Page 3 of 11
 * Vaccination record or immunization
status in Hepatitis B and Influenza
10. The staff are provided Document Review
with a documented job e List of personnel with designation
description outlining e Written job description or duties and
accountabilities and responsibilities of all laboratory personnel
responsibilities and designation of workload

Observe
e Posted work schedule and area assignment
signed and approved by HOL
e Presence of support staff such as encoders
and/or receptionists, as applicable
11.The HOL shall have Document Review
the overall supervision
technical
e Proof of supervisory visits:
on *
Non-hospital based — once a week for
procedures as well as physical visit OR once a month physical
on the administrative visit with at least twice a week of
laboratory supervisory calls and/or video
management conferencing
* Hospital-based — at least once a week
physical visit
12.There is and an Document Review
adequate number of e List of personnel with designation
qualified e Area of assignments indicated in the posted
RMT/analysts, and work schedule/workload and assignment
other personnel signed and approved by HOL

Observe
e Presence of support staff such as but not
limited to laboratory technician, laboratory
aide, encoders, and receptionists as applicable

. There are an adequate Document Review

and appropriate areas e Approved copy of DOH-PTC, floor plans and
to safely, effectively checklist for review of floor plan
and efficiently provide
the services to clients (Observe
e Presence of eyewash
e Appropriate room signages and biohazard
warning signs
14. There is program of Document Review
proper maintenance e Written policy and program for the proper
and monitoring of maintenance and monitoring of physical plant
physical plant and and facilities
facilities e Proposed schedule for preventive and
corrective maintenance and/or request for
maintenance

Observe
e Updated proof of actual implementation of
maintenance as to structure, ventilation,
lighting & water supply
e Adequate ventilation, lighting & water supply
are providedin all areas

DOH-HFSRB-QOP-01-CLMP-AT-Annex B
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 CRITERIA INDICATOR/EVIDENCE COMPLIED REMARKS
15. There are policies and Document Review
procedures in proper] e Written policies and procedures on waste
waste management management, handling and disposal that
including handling and conform with Republic Act (RA) No. 6969
disposal of waste and and Healthcare Waste Management Manual,
hazardous/ infectious and other relevant laws and issuances
substances e Notarized Memorandum of Agreement
(MOA) with DENR accredited hauler/ EMB
Certificate, as applicable (no hauler) for
infectious waste, toxic, and hazardous
substances

Observe
¢Implementation of waste segregation
Proper labeling of waste receptacles
e
¢ Proper managements and/or disinfection of
temporary waste holding areas prior to
hauling for disposal
16. The organization Document Review
follows and documents e Written policies/procedures on the operation
the policies and and maintenance of equipment, machine
procedures for the safe ® Records on compliance to biosafety cabinet
and efficient use of
laboratory
standards, as
applicable
e List of available and functional laboratory
equipment/instruments equipment to provide the laboratory
examinations/services which reflects the
serial number and date of purchase, as
applicable
e Records of regular schedule and frequency of
preventive maintenance and calibration
e Records of corrective repair maintenance with
service reports or log sheet
e Written policies and procedures in case of
equipment breakdown and malfunction

Observe
e All laboratory machine/equipment and
instruments are functional
e Presence of operating manuals of the
equipment
e Preventive and corrective maintenance
logbook and plan for replacement
17. There is an adequate Document Review
supply of properly} e¢
Updated quality records of supplies /reagents
stored and inventoried with expiration date, usage/consumption and
reagents and supplies disposal
for the laboratory} « Certificate of Product Registration or its
examinations/services equivalent from the Philippine Food and Drug
Administration (FDA), as applicable
¢ Documented records of in-house
validation/verification of diagnostic tests

Observe
e Availability and unexpired reagents and
supplies
18.The reagents and] Observe
supplies are stored} e Records of temperature monitoring as

\
under the required follows:
conditions with + Room temperature reading
( DOH-HFSRB-QOP-01-CLMP-AT-Annex B
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‘\ 11.102023
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 CRITERIA INDICATOR/EVIDENCE COMPLIED REMARKS
adequate storage *
Refrigerator and freezer temperature
facilities such as reading
refrigerators for] e Availability of appropriate thermometer
perishable reagents
and supplies
19. There is an appropriate Document Review
storage facilities/area| e Material Safety Data Sheet (MSDS) available
and technique for for all reagents/supplies and accessible to
all
flammable, personnel at all times
combustible and
hazardous Observe
chemical/reagents e Organized per section with National Fire
Protection Association (NFPA) Label or its
equivalent

CHa TIRS
___
EQUIPMENT
/
INSTRUMENT /
GLASSWARE/SUPPLIES
Instructions or procedures for the spill clean up
REAGENT/S
Sree
REMARKS
(Quality Improvement)

Disinfectant
Spill Kit a5
Autoclavable biohazard waste bags
__

__ Biological Safety
Cabinet
Biomedical refrigerator
(BSC) II
__
Biomedical freezer
__
Gloves
__
Autoclave
__
__ Computer
__ Microcentrifuge
__ Micropipette tips
__ Minicentrifuge
Set of micropipettes with rack, ranging from 0.5
__
Specimen Preparation to 1000 microliter (11)
to Processing __
Vortex Mixer

As applicable:
block (for extraction kits that requires
__ Heating
heating for elution buffer)
Cold block
__
PCR Cabinet
__
PCR Machine
__
Laminar Flow/Hood
__
Automated Template Adding Machine
__
Cartridge-based machine with kits or cartridges
Indicate the equipment/machine/device/
instrument used fortesting:

NOTE: The quantity of the above-mentioned may be increased depending on purpose, manpower and workload of the laboratory.

DOH-HFSRB-QOP-01-CLMP-AT-Annex B
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Page 6 of 11
7
CRITERIA INDICATOR/EVIDENCE COMPLIED REMARKS

20. There are Document Review

administrative policies @ Documented policies/procedures for the
and procedures for the provision of laboratory services
provision and conduct ¢ Documented policies/procedures in the
of laboratory services operation and maintenance of the laboratory
and activities, and such as security of supplies, specimens,
operation and confidentiality of records, material
maintenance of the accountability, and inventory control
laboratory e¢
Contingency plan (referred test or back-up
machine) in case of emergencies such as
machine malfunction/equipment breakdown,
unavailability of supplies and reagents in the
market, laboratory contamination, and the like
21. There are policies and Document review
procedures for e Written policies/procedures for reporting and
reporting and analysis analysis of incidents, adverse events
of incidents, adverse e Compiled of written reports with analysis
events, and other and/or resolutions and/or corrective actions
related process taken
22.There are policies] Document Review
guidelines on| e Written policies/procedures for laboratory
laboratory biosafety biosafety and biosecurity including but not
and biosecurity limited to the following items:
+ Specific entry requirements (laboratory
access, training, immunization, respirator
fit test, authorization for work, etc.)
* Personal Protective Equipment (PPE) -
procedure for PPE donning and doffing,
reuse / extended use/ washing or cleaning
PPE, disposal of used PPE, fit testing,
specifications
+ Decontamination and waste management
(procedure specific (e.g., type of
decontamination method such as
chemical or wet heat via autoclave;
schedule of waste disposal; temporary
waste storage and schedule of disposal,
and transport of waste); schedule of
routine cleaning and decontamination
process
+ Transport and referral of biological
material (procedure/ policy or
Memorandum of Agreement (MOA) or
related documents) - for local and
international
+ Emergency Response (biological
emergency response) including drill and
actual clean up response
+ Maintenance and operation of BSC and
other primary containment devices
+ Facility’s heating, ventilation, and air
conditioning (HVAC) maintenance
related documents
+ Specimen banking (retention), sharing,
storage, and disposition

DOH-HFSRB-QOP-01-CLMP-AT-Annex B
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Page
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 CRITERIA INDICATOR/EVIDENCE COMPLIED REMARKS
+ Risk assessment and biorisk management
(including report of accidents and
incidents)

Observe
Good microbiological practices including
movement of people, specimen, and waste
Limited access control is being implemented
in the facility with provision of lock and key
features
Presence of a designated Biosafety and
Biosecurity Officer
23. There are policies and Document Review
proceduresfor the Written policies/procedures in specimen
receipt of samples, handling, shipping, transport, receiving, and
performance of performance of laboratory tests
laboratory tests and Written policies/procedures in reporting,
reporting/releasing of releasing, and validation of laboratory results
results Written policies/procedures on the use of
electronic signatures of the pathologists and
the RMT analyst, as applicable, in accordance
with E-commerce law
Written policies/procedures on the re-issuance
and/or retrieval of records, if applicable
Written policies/procedures on the use of
Laboratory Information System, as applicable
24. The laboratory report Document Review
forms on various CL Updated records of results from entry,
examinations releasing, and endorsement, which may be in
the form of logbooks or electronically stored
data with back up

Observe
Laboratory report forms and/or CL official
results bears the name and original or
electronic signature with PRC ID No. of the
HOL
or his/her associate pathologist and the
RMT analyst/s who performed the test

25. There are policies and Document review

proceduresfor the Written policies/procedures on_ retention
retention and/or and/or disposal of documents, records, slides,
disposal of
documents, records,
and specimens of the laboratory following the
standards promulgated by the DOH and/or
slides, and specimens competent professional organizations
of the laboratory
which shall follow
standards promulgated
by the DOH (DC No.
2021-0226 and AO
No. 2022-0007)
and/or competent
professional
organizations
26. The prices for Document Review
laboratory services are Updated laboratory services with
readily available and corresponding prices and/or price lists are
accessible to the readily available and accessible to
public as mandated by client/public which can be in any of the
RA No. 11223 and following form:
DOH-HFSRB-QOP-01-CLMP-AT-Annex B
Revision: 00

\ fox it
eal /102023.
1
 CRITERIA INDICATOR/EVIDENCE COMPLIED REMARKS
related DOH + Printed handout
issuances * Booklet
+ Digital form
« Poster/tarpaulin
+ _Online/website
21s The organization Document Review
follows and e Written policies/procedures on outsourcing of
documents the examinations
policies and List of outsourced examinations
procedures on Written policies/procedures on referred tests
outsourcing of (if no back up machine) as part of contingency
laboratory plan, if applicable
examinations, and
referral if applicable
e Records of referred examinations with date of
referral, as applicable
e Copy of DOH-LTO of the CL (or its
equivalent) where specimens will be
outsourced or referred
e Valid and notarized MOA between parties

x There
QUALITY IMPROVEMENT ACTIVITIES
Document review
. are policies and
procedures for Quality e Written policies/procedures for internal QAP,
Assurance Program conduct of quality control, inventory control,
(QAP) and continuous and related processes
quality improvement e Updated quality records of conducted quality
control per test and filed accordingly, either
printed worksheet or electronically stored with
back
up as
proof ofactual performance
e Records of results/findings of QAP audits or
assessments

Observe
e Availability of reference materials and
appropriate equipment, supplies, reagents
29. Participation in Document review
External QAP e Documented policies/procedure in the actual
(EQAP) that may be performance of EQAP activities and
administered by a corrective actions to be taken in case of non-
designated NRL or conformity/failed results
other international e Certificate of Performance in EQAP with
EQAP recognized by passing results, once available
the DOH (once e Proof of corrective actions taken, in case of
available) failure/non-passing in EQAP, as applicable

DOH-HFSRB-QOP-01-CLMP-AT-Annex B
Revision: 00
11/10/2023
Page
9 of 11
 Republic of the Philippines
Department Health of
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Facility:
Date of Inspection:

RECOMMENDATIONS:
For Licensing Process
[ ] For Issuance of License to Operate as:
Validity from to

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-QOP-01-CLMP-AT-Annex B
Revision: 00
94.:/402023
Page 10 of 11
 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:

‘\ DOH-HFSRB-QOP-01-CLMP-AT-Annex B
Revision: 00
41142023
Page 11 of 11 t
 AO No. 2023 -_DO18
ANNEX C
Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

CHECKLIST FOR REVIEW OF FLOOR PLANS

CLINICAL LABORATORY FOR MOLECULAR PATHOLOGY
Name
of Health Facility:
Address:
Date: Review: 1 nd 30
Platform used:

1. PHYSICAL PLANT
___1.1. Clinical Working Area
___1.1.1. Pre-analysis room/s for specimen receiving and specimen handling/ sample
preparation
___1.1.2.1, Specimen receiving/unboxing/handling/sample preparation
room/area(s) with work counter with laboratory deep sink
___1.1.2. Reagent preparation room with work counter (optional)
___1.1.3. Analysis room with work counter
___1.1.4. Anteroom(s) for donning and/or doffing
___1,2. Support Area
___1.2.1. Business area *
___1.2.1.1. Reception area/counter (receiving of specimen / releasing of
laboratory results/ post-analysis) *

___1.2,1.2, Waiting area (commensurate 0.65 sq.m. per person) *

1.2.2. Collection area (optional) *
1.2.3. Waste holding room/area *
WELL
1.2.4. Toilet with lavatory/sink (located outside the clinical working area) *
1.2.5. Pathologist room/area *
1.2.6. Staff pantry (located outside the clinical working area) *

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. It shall be in a secured yet accessible location for receiving
of specimen.
Different areas should be properly zoned depending on the
___ 2.3.1.2. level of access: public, semi-restricted and restricted areas.
2.3.1.3. For institution-based laboratories, it should be located and
____
zoned depending on
zone!).
its
functional requirement (e.g. second

* - Optional
for institution-based molecular laboratory and molecular laboratory within a general clinical laboratory, provided
identified within the DOH-regulated health facility the molecular laboratory is located, and is accessible from the molecular
it is

laboratory
'
Second Zone- areas that receive workload from the outer zone (areas immediately accessible to the public) e.g. laboratory,
pharmacy and radiology, in which shall be located near the outer zone.

:
DOH-HFSRB-QOP-01-CLMP-PTC-CR-Annex C
i
Revision: 00
1440/2023
Page 1 of Al
 ____2.3,2, Floor plan suggests unidirectional workflow process from receiving of
specimento results data processing.
Door access from service corridor and rooms housing large equipment
____2.3.3.
shall be wide enough to accommodate entry and exit of equipment, as
applicable.
____2,3.4. Internal windows (e.g. viewing glass panels) are laid out to promote visual
observation between work rooms as applicable.
Provision for toilet and other amenities for laboratory staff are located
____2.3,5.
outside the clinical working area.
____2.3.6. The laboratory shall have adequate space or area provided for its various
space/room requirements in to
order attain the effective and efficient
its
operation of activities and functions.
____2.3.7. Adequate clearances intended for working space and equipment in the
clinical working area shall be provided to ensure efficient workflow and
ergonomics.
___2.3.8. Provision of pass boxes to and in between rooms within the clinical work
area, is recommendatory, to attain appropriate workflow.
___2.3.9. There shall be provision of sufficient and appropriate storage provided for
specimens, supplies and records.
____
2.4. Conforms to the applicable codes as part of normal professional practice.
____2.2.1. if
Corridor within the laboratory, any, has a minimum clear and
unobstructed width of 1.20 meters.
____2.2.2. Emergency eyewash, preferably hands-free, shall be provided within the
laboratory (Emergency shower is also recommendatory).

3. Ventilation with acceptable air changes shall be maintained in the laboratory.

____3.1. The pre-analysis room/s shall have a negative pressure room conditioned and itsexhaust
must produce atleast 6-air changes per hour (ach).
____3.2. The analysis room shall have a negative pressure room conditioned and its exhaust must
at
produce least 6 ach.
3.3. Exhaust shall be discharged away from the general public. Additional exhaust
requirements must be installed (e.g. bag-in bag-out high efficiency particulate air filter
box or stacked exhaust), based on the risk assessment.
____3.4. Exhaust air grille locations must be in the dirty side of the laboratory preferably on top
of the biosafety cabinet (BSC).
____3.5. Supply air grille locations were on the clean side of the laboratory preferably near
entrance doors. (optional)
3.6. Supply air direction should be away from the BSC, and other containment equipment
____
(if any).
3.7. Under no circumstances should the exhaust air from the processing rooms (pre-
analysis and analysis) be recirculated to other areas.
3.8. Directional airflow from clean to dirty areas is achieved.
3.9. BSC location must be away from high foot traffic area.

i
DOH-HFSRB-QOP-01-CLMP-PTC-CR-Annex C
{

: Revision: 00 i

40202347
Page 20f3°:
 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

:
DOH-HFSRB-QOP-01-CLMP-PTC-CR-Annex C

t
Revision: 00:
14/10/2023
Page 3 of 3°:
 AO No. 2023 -_0018
ANNEX D
Republic of the Philippines
Department of Health

CHECKLIST FOR REVIEW OF FLOOR PLANS

CLINICAL LABORATORY FOR MOLECULAR PATHOLOGY
(Performing Hybridization Technique, Clinical Cytogenetic Test, or Cartridge-Based Technology)

Name
of
Address:
Health Facility:

Date: Review: 1* 2nd 30

Platform used:

1. PHYSICAL PLANT
___1.1. Clinical Working Area
___1.1.1. Processing room(s)
___1.1.2.1. Change room/area(s) for donning and/or doffing
___1.1.2.2. Pre-analysis room/area with work counter and sink
1.1.2.3. Analysis room/area with work counter
___
____1.2. Support Area
___1.2.1. Business area*
___1.2.1.1. Reception area/counter (receiving of specimen / releasing of
laboratory results/ post-analysis) *
___1,2.1.2. Waiting area (commensurate 0.65 sq.m. per person) *
1.2.2. Collection Area (optional) *
___1.2.3. Waste holding room/area *
___1.2.4. Toilet with lavatory/sink (located outside the clinical working area) *
*
___1.2.5. Pathologist room/area
__1.2.6. Staff Pantry / lounge (located outside the clinical working area) *

Note; For molecular laboratories performing conventional platform and existing DOH-licensed clinical laboratories performing
microbiology tests, which will also intend to provide cartridge-based technology testing platform/s (e.g. GeneXpert), room(s) may
be co-shared.

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. It shall be in a secured yet accessible location for receiving of
____
specimen.
____2,3.1.2. Different areas should be properly zoned depending on the
level of access: public, semi-restricted and restricted areas.
____2,3.1.3. For institution-based laboratories, it should be located and
zoned depending on its functional requirement (second
zone!).

* - Optional
for institution-based molecular laboratory and molecular laboratory within a general clinical laboratory, provided
identified within the DOH-regulated health facility the molecular laboratory is located, and is accessible from the molecular
is
it
laboratory.
!
Second Zone- areas that receive workload from the outer zone (areas immediately accessible to the public) e.g. laboratory,
pharmacy and radiology, in which shall be located near the outer zone,

DOH-HFSRB-QOP-01-CLMPO-PTC-CR-Annex D
Revision: 00
“\ 114020234
Page 1 of 3
 ____2.3.2. Door access from service corridor and rooms housing large equipment shall
have at least 1.00 meter clear width to accommodate entry and exit of
equipment, as applicable.
___2.3.3. Internal windows (e.g. viewing glass panels) are laid out to promote visual
observation between work rooms as applicable.
Provision for toilet and other amenities for laboratory staff are located
____2.3.4.
outside the clinical working area.
___2.3.5. The laboratory shall have adequate space or area provided for its various
space/room requirements in order to attain the effective and efficient
operation of its activities and functions.
____2.3.6. Adequate clearances intended for working space and equipment in the
clinical working area shall be provided to ensure efficient workflow and
ergonomics.
2.3.7. There shall be provision of sufficient and appropriate storage provided for
____
specimens, supplies and records.
____2.4. Conforms to the applicable codes as part of normal professional practice.
____2.2.1. Corridor within the laboratory, if any, has a minimum clear and
unobstructed width of 1.20 meters.
____2.2.2. Emergency eyewash, preferably hands-free, shall be provided within the
laboratory (Emergency shower is also recommendatory).

3. Ventilation with acceptable air changes shall be maintained in the laboratory.

3.1. The pre-analysis room should preferably have a negative pressure room conditioned and
____
its exhaust must produce
___3.2. Exhaust air
at
least 6-air changes per hour (ach).
grille locations must be
in the dirty side of the laboratory preferably on top
of the biosafety cabinet (BSC).
___3.3. Supply air direction should be away from the BSC, and other containment equipment
(if any).
___3.4, Under no circumstances should the exhaust air from the pre-analysis room be
recirculated to other areas.
___3.5. Directional airflow from clean to dirty areas is achieved.
___3.6. BSC location must be away from high foot traffic area.

COMMENTS:

DOH-HFSRB-QOP-01-CLMPO-PTC-CR-Annex D
Revision: 00
4410/2023
Page 2 of 3
 Republic of the Philippines

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

OQH-HFSRB-QOP-01-CLMPO-PTC-CR-Annex D i

Revision: 00 [

Aqr2023¢ j

Page 3 of
3: