Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

October 17, 2022

DEPARTMENT MEMORANDUM
No. 2022 -

FOR : DIRECTORS OF DOH CENTERS FOR HEALTH

DEVELOPMENT; CHIEFS OF THE HEALTH
FACILITIES AND SERVICES REGULATORY
BUREAU; CHIEFS OF REGULATION, LICENSING
AND EFORCEMENT DIVISION; REGULATORY
OFFICERS; AND ALL OTHER CONCERNED
OFFICES

SUBJECT : Reiteration of the Transitory Provisions of the

Administrative Order No. 2021-0037 titled “New Rules
and_ Regulation Governing the Regulation of Clinical
Laboratories in the Philippines”

Administrative Order (AO) No. 2021-0037 titled “New Rules and Regulations Governing
the regulation of Clinical Laboratories in the Philippines,” issued on June 11, 2021, and took
effect fifteen (15) days following its publication on July 7, 2021, in a newspaper of general
circulation.

This Order rescinded AO No. 2007-0027 or the “Revised Rules and Regulations Governing
the Licensure and Regulation of Clinical Laboratories in the Philippines,” and provided an
updated clinical laboratory classification by service capability with upgraded clinical
laboratory test. This upgrade corresponded with new licensing requirements in terms of
human resources and physical infrastructure to ensure timely delivery of service.
Nevertheless, the AO provided a transitory provision to all existing DOH-licensed clinical
laboratories to be able to prepare and fully comply with the minimum standards.

As such, all existing DOH-licensed clinical laboratories shall be given two (2) years, until
2023, to fully offer the additional services for each category with the corresponding
personnel and equipment, and three (3) years, until 2024, to comply with the physical plant
requirements.

Thus, this Department Memorandum (DM) is

being issued to reiterate the timeline for
harmonized implementation of AO No. 2021-0037, pending the approval and issuance of
the amendment.

To ensure uniformity in the conduct of inspection and monitoring activities, and issuance of
violations and sanctions of regulatory officers to existing DOH-licensed clinical

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 @ URL: http:/Avww.doh.gov.ph, e-mail: dohosec@doh.gov.ph
laboratories, a guide was developed (attached herein as Annex A) which may be used as a
reference during field visits.

Health Regulation Team

 ANNEX A. Provisions of the Assessment Tool of the Administrative Order No. 2021-0037
Legend:
‘HE - Licensing standards as applicable depending on the services offered.

IMPLEMENTATION
Shall be implemented
starting October 1,
2023 onwards
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance
I. ORGANIZATION AND The organization's management team provides leadership
MANAGEMENT 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 organizational structure that Observe
clearly reflects the line of authorities, ¢ Updated organizational chart is posted/displayed in
accountability, communication, (at
conspicuous area with the names, latest pictures
interrelationship, hierarchy of functions and least passport size) and designation
flow of referrals
2. The organization’s mission, vision, and goals Document Review
shall be in accordance with Republic Act e Written vision, mission, and goals
(RA) No. 4688 Observe
¢ Vision, mission, and goals posted or displayed in a
conspicuous area visible to clients
3. The organization has a valid DOH- LTO and Document Review
other pertinent documents *®
Compiled clinical laboratory (CL) Administrative 4
Order (AO), reports of inspection and/or
monitoring
Observe
* Valid DOH-LTO posted in a conspicuous area 4
visible to clients
4. There
is
a policy and procedure on Document Review
management review e Written policy on management review
* Compiled documented minutes of meeting 4
Teflecting the date, time, attendance, agenda, and
action taken signed_and approved by head of

Page 1 of 11
 IMPLEMENTATION
Shall be implemented
starting October 1,
2023 onwards
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance)
laboratory (HOL), held at least twice a year or as
needed
e Supporting documents for evaluation and
monitoring of activities such as records, logbooks,
checklist of supplies, inspection report, purchasing
or procurement and acceptance of supplies, etc.
5. There are policies and procedures for Document Review
handling complaints and client feedback © Written policy and procedure for client feedback
and handling complaints
Records/forms for complaints/client feedback
*
* Records/documented analysis of complaints/client
a
feedback and corrective actions taken
Observe
* Suggestion box visible to clients
II. HUMAN RESOURCE MANAGEMENT A. Staff Recruitment, Selection, Appointment and
Responsibilities
There is policy and procedure for hiring, Document Review
orientation and promotion for all levels of « Written policies and procedures on hiring,
personnel orientation, and promotion of personnel at all
levels
There is policy and procedure on continuing Document Review
program for staff development and training © Written policies and procedures for staff
development and training
¢ Proof of training through relevant certificates,
memos, written reports, budgetary allocations
Interview
e Human Resources Management Officer/ Personnel
Officer
There is policy and procedure for discipline, Document Review
suspension, demotion, and termination of © Written policies and procedures on discipline,
personnel atall levels suspension, demotion and termination of personnel
at all levels

Page 2 of 14
 IMPLEMENTATION
Shall be implemented
starting October
2023 onwards
1,
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance

9. The duties and responsibilities shall be Document Review

clearly stated ¢ Written job description or duties and a
responsibilities of all laboratory personnel
10. There is an adequate number ofqualified Document Review
personnel with documented training and © List of personnel with designation mM

experience to conduct/perform the laboratory Area of assignments indicated in the posted work 4
procedures schedule and assignment signed and approved by
HOL
e There is a policy whenever there is an increase in 4
workload, there shall be a corresponding increase in
the number of personnel.
© There
is
a policy on hiring or designating additional Mw

personnel as:
Proof of attendance
Proof of qualifications (please refer to specific
personnel)
« Authority to practice signed by the head of the
government facility, if applicable (A.O. # 92 s.
2003)
11. There is policy on the implementation of Document Review
National Database of Human Resource for
Health Information System (NDHRIS)
© Proof of
submission of data to NDHRHIS

12. Each personnel shall have a record of updated Document Review

201
files e Updated 201 files of all CL personnel
A. The Head of the Laboratory (HOL) shall Document Review
have the overall supervision on technical |e Proof of supervisory visits at least once a week for
procedures as well as on the physical visit OR once a month physical visit with at
administrative laboratory management least twice a week of supervisory calls and/or video
conferencing
« For HOL of hospital-based clinical laboratory: 4
supervisory physical visits of at least once a week

Page 3 of 11
 IMPLEMENTATION
Shail be implemented
starting October 1,
2023 onwards
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance)
e Proof of qualifications:
* Updated Resume
Valid certificate and PRC ID
SSS8a8

PSP Board Certificate

Notarized employment contract
Annual Medical Certificate
Certificate of Good Standing from PSP
8
*

* Relevant training certificates (e.g., Molecular With on-going

Pathology) training from
2021-2023
* Proof of
immunization (Hepatitis B and
Influenza)
B. Registered Medical Technologist (RMT) Document Review
¢ Proof of qualifications:
(At least 1
competent RMT
per assigned *
Updated Resume
area) PRC certificate and valid PRC ID
Relevant training certificates
SSRAaR

Notarized employment contract

Annual Health Status (Latest Medical
Certificate)
«Vaccination record (Hepatitis B and Influenza)
RMT staff withdesignated assignments, as
Additional proof of trainings
_applicable:
1. rHIVda Training Certificate of Proficiency (SACCL)
2. _AFB microscopy Certificate of training on DSSM (NTRL) a8
Certificate of training in bacteriology (RITM and other
3. Bacteriology
RITM recognized institutions)
If the facility
4. Malaria smear Certificate of training in malaria smear (RITM) offers malaria
test.
5. Others

Page 4 of 11
 IMPLEMENTATION
Shall be implemented
starting October
2023 onwards
1,
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance)
Designate a
Document Review
RMT staffshall
« PRCcertificate and valid PRC ID (RMT)
4 be immediately
C. Biosafety and Biosecurity applicable.
¢ Certificate of training in Biosafety and Biosecurity
With on-going
(RITM and/or UP-NTCBB)
training from
2021-2023
1. Clinical Laboratory for Clinical and Anatomic Pathology
PRIMARY SECONDARY TERTIARY
SERVICES 4st 2nd 3r is zea gra 1* zed 30
Shift Shift Shift Shift Shift Shift Shift Shift Shift
Clinical Microscopy 1 1 1 1 1 1 1 1 1

Hematology 1 1 1 1 1 1 1 1 1

Clinical Chemistry 1 1 1 1 1 1 1

Immunology/Serology 1
1 1
Microbiology 1
1
Histopathology 1

Total 2 2 2 4 3 3 6 4 4
& (7#1 reliever) 12 (1141 reliever)
without .
without
Overall Microbiology .
12 (11+1 reliever)
7

9 (8+ reliever) for Histopathology

13 (12+1 reliever)
Government
for Hospital-based
facilities
Note: An increase in workload shall require a corresponding increase in the number of personnel
2. Clinical Laboratory for Anatomic Pathology — At least one RMT
per section
3. Clinical Laboratory for Molecular Pathology — will depend on the services offered
If. PHYSICAL PLANT, FACILITIES, AND
WORK ENVIRONMENT
Document Review

Page 5 of 11
 IMPLEMENTATION
Shall be implemented
1,
starting October
2023 onwards
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance)
13. There is program of proper maintenance and « Written policy and program for the proper
monitoring of physical plant and facilities maintenance and monitoring of physical plant and
facilities
Proposed schedule for preventive maintenance
«
Observe
8
* Updated proof of actual implementation of
maintenance as
water supply
to
structure, ventilation, lighting &

14. There are policy guidelines on laboratory Document Review Part of renewal
biosafety and biosecurity « Local risk assessment reviewed at least annually starting 2021
« Written protocols on laboratory biosafety and &
biosecurity
Observe
Good Laboratory Practice that includes use of Personal
Protective Equipment and other precautionary measures
15. There is a policy and procedure for the proper Document Review
disposal of waste and hazardous/infectious ¢ Policy on disposal of wastes that conform with
substances that shall conform to the standards Healthcare Waste Management Manual, and RA
set by the DOH No. 6969
« Notarized Memorandum of Agreement (MOA)
with infectious waste, toxic, and hazardous
substances hauler
Observe
« Proof of proper management of wastes from point
of generation, segregation (color-coded waste
bins), disinfection, up to the final disposal

IV. EQUIPMENT/INSTRUMENTS

16. There is an adequate number of operational Document Review

equipment to provide the laboratory « List of available and functional laboratory
equipment

Page 6 of 11
 IMPLEMENTATION
Shall be implemented
starting October
2023 onwards
1,
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance)
examinations that the laboratory is licensed Observe
for e All laboratory equipment and instruments are
operational
17. There is program for calibration, preventive Document Review
maintenance andrepair for the equipment. ¢ Regular schedule including frequency of w
preventive maintenance and calibration
©
Updated certificate of calibration and maintenance 4
of equipment
e Record of repair reports 4
18. There is contingency plan in case of Document Review
equipment breakdown © Written policy on contingency plan in case of 4
equipment breakdown

V. REAGENTS AND SUPPLIES

19. There is an adequate supplyof properly stored Document Review
and inventoried reagents and supplies for the |e Quality records of supplies /reagents with w
laboratory examinations to be provided. expiration date, their usage/ consumption and
disposal are available
e Certificate of Product Registration from FDA,
including the reagents, supplies, and equipment
used for POCT and MCL
Observe Should
e Availability and completeness of reagents and 4 complement the
supplies classification
and services
¢ Validate the expiration dates of reagents wi offered by the
facility
20. The reagents and supplies are stored under the Document Review
required conditions with adequate storage « Records of temperature monitoring as follows: a
facilities such as refrigerators for perishable ¢ Room temperature reading
reagents and supplies * Refrigerator and freezer temperature reading

Page 7 of 11
 IMPLEMENTATION
Shall be implemented
starting October 1,
2023 onwards
Requirements {compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance)
Observe
¢ Monitoring of room temperature My

«©
Temperature of refrigerators (2°C to 8°C) and
freezers (-20°C to -30°C)
21. There is an appropriate storage area/technique Document Review
for flammable, combustible and hazardous e Material Safety Data Sheet (MSDS) available for 4
chemical/reagents all reagents/supplies and accessible to all personnel
at all times
Observe
© Organized per section with National Fire Protection 4
Association (NFPA) Label or
its
equivalent
VI. ADMINISTRATIVE AND TECHNICAL
POLICIES AND PROCEDURES
22. There is an administrative policies & Document Review
procedures for provision of laboratory All documented policies, protocols, procedures are
services and for the operation and signed and approved by the head of laboratory
maintenance of the laboratory © Guidelines in the operation and maintenance of
the
laboratory including policy on security of supplies,
specimens and confidentiality of records
Pursuant to AO
e Laboratory services and corresponding prices are No. 2021-0008,
accessible to the public applicable
immediately
23, The technical procedures of services provided Document Review
by each section are available © Documented and updated policies and procedures
of laboratory services ineach of the sections/areas.
* Documented policies, protocols, and guidelines in
the operation and maintenance of
the laborato:

.
;

There are procedures

eat
for the receipt and Document Review
performance of laboratory tests * Documented procedures for receipt and
performance of laboratory tests

Page 8 of 11
 IMPLEMENTATION
Shall be implemented
: starting October 1,
2023 onwards
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1,
2023,
and should not be a
basis for non-
compliance)
25, There are procedures for reporting of results Document Review
of laboratory tests « Documented procedures for reporting of results of 4
laboratory tests
© Documented procedures for the validation of wy

laboratory results prior to reporting

26. The laboratory reports on various| Document Review
examinations of specimens: ©
Laboratory report forms bearing the name and 4
A. shall bear the name of the pathologist or
designated associate who shall be
original/digital signature with PRC ID No. of the
head of the laboratory and the RMT analysts
responsible for the reliability of the Updated records of result (logbooks/ electronically wi
results stored data with back up) including entry, releasing
B. The reports shall also bear the name of & endorsement records.
the RMT(s) who performed
examinations and duly signed by
the|. ‘There is a policy guideline on the use of
authenticated electronic/digital signature that is in
that/those person(s) accordance with the E-commerce law
e Documented policy for Laboratory Information

27. There are procedures for reporting of

System, if
Document review
available

workload, quality control, inventory control, e Documented procedures for reporting of workload,
ete. quality control, inventory control, etc.
©
Updated reports and documents (hard or soft copy
with back up)
© Worksheets/machine print out per section as proof
of actual performance

28. There isa procedure for reporting and analysis
of incidents, adverse events, and other related
process.
29, There is a documented procedure on the
retention of documents, records, slides, and
specimens of the clinical laboratory which
Document review
| Documented procedures for reporting and analysis
of incidents, adverse events, etc.
Compiled of written reports with resolutions
Document review
Documented procedure for the retention of records
which follows standards promulgated by the DOH

Page 9 of 14
 IMPLEMENTATION
Shall be implemented
starting October
2023 onwards
1,
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance)
shall follow standards promulgated by the w
DOH (DC# 70 s. 1996) and/or competent
¢ Compiled laboratory tests results, whether logbook
or electronically stored
professional organizations
B. Quality Assurance
30. There is a policy on Quality Assurance Document review
Program (QAP) and Continuous Quality « Documented Internal QAP including Internal 4
Improvement Quality Control and Continuous Quality
Improvement
« Availability of reference materials and appropriate
reagents & equipment used
e Availability of reference materials and appropriate
reagents & equipment used
©
Results/findings of Quality Assurance audits /
assessments
31. There is a proof of participation in External Document review
QAP (EQAP) that may be administered bya ¢ Documented procedure in the actual performance
designated NRL or other local and of EQAP activities
international EQAP approved by the DOH © Certificate of Performance in EQAP with passing
rate

Tests
32. There is a policy on referral and outsourcing Document Review
of examinations * Documented procedures on referral and
outsourcing of examinations to
other DOH licensed
clinical laboratory
e Records of outsourced examinations (in the event
of machine breakdown)
* Notarized Memorandum of Agreement

© DOH-LTO of referral testing laboratory

Page 10 of 14
 IMPLEMENTATION
Shall be implemented
starting October 1,
2023 onwards
Requirements (compliance with the
CRITERIA INDICATOR/EVIDENCE which shall be requirements will be REMARKS
implemented given a grace period
immediately until October 1, 2023,
and should not be a
basis for non-
compliance
VII. POINT OF CARE TESTING (POCT)

33. There is a policy on POCT Document Review As applicable

* Documented list of POCT operators, machines,
instruments and kits
Documented procedure on the conduct of periodic As applicable
assessment by representatives from the top
management, clinical laboratory, clinical
departments and nursing service, to evaluate the
olicy of the clinical laboratory on POCT

VII. MOBILE CLINICAL LABORATORY

34. There is a policy on Mobile Clinical Document Review As applicable

Laboratory Documented Procedures on
* Collection of specimens
* Processing of specimens
Land Transportation Office Registration (proof of As applicable
ownership)
File of Memorandum of Agreement between the As applicable
clinical laboratory and the facility where the mobile
activity is conducted

Page 11 of 11