A.O. No.

2021 - JMZ
ANNEXB1
Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL LABORATORY

INSTRUCTIONS:
1. To property fill-out this tool, the Licensing Officershall make use of: INTERVIEWS, REVIEW OF DOCUMENTTS,
OBSERVATIONS and VALIDATION of findings.
2. If the corresponding items are present, available or adequate, nlace a (%✓) on each of the appropriate spaces
under the COMPLIED column or space provided alongside each corresponding item. If not, put an (X) instead.
3. Tfte 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 tod.
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: fl/tyVlCOllfto Cjypl'o
Hoor /iobmsons
Complete Address:
Numbers Street B a rang a//District

, Cetow City VI)

Municipality/City Province/Region

Contact Information: O^lpsoif E-mail Address: fyiyhea |W) |. cOto

Initial M Renewal [ 1
Existing License Date Issued: Expiry Date:
Number:
M-ecV.fV) -f&Vices Svk.
Name of Owner or Governing Body (if corporation):

Name of Head of Laboratory: A- Movetoo vio j pprp

Classification According to:

Ownership: □ Government Drivate

Function: p' Clinical Pathology □ Anatomic Pathology

□ Molecular Laboratory

Institutional-Character: jif' Non-Institution Based Institution-based

Specify Institution^
□ DOH Based Program
Service Capability Primary
Laboratory
□ Secondary □ Li mi ted-Service Capability

□ Tertiary □ Mobile Clinical Laboratory

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r INDICATOR/EVIDENCE COMPLIED . : ' .

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ORGANIZATION AND MANAGEMENT
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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 chart is
structure that posted/displayed in
clearly reflects ’ conspicuous area with the
the line of names, latest pictures (at least
authorities, passport size) and designation
accountability,
communication,
interrelationship,
hierarchy of
functions and
flow of referrals
2. The Document Review
organization’s • Written vision, mission, and
mission, vision goals
and objectives
shall be in Observe
accordance with • Vision, mission, and goals
RA 4688 posted/displayed in a
conspicuous area visible to
clients
3. The organization Document Review
has a valid • Compilation of Clinical
DOH-LTO and Laboratory AOs, Reports of
other pertinent Inspection/Monitoring
documents
Observe
• Valid DOH-LTO posted in a
conspicuous area visible to |\)A initial
clients
4. There is a policy Document Review
and procedure • Written policy on management
on management review
review • Compilation of documented
minutes of meeting reflecting
the date, time, attendance,
agenda, and action taken
MA imKfll
signed and approved by head of
laboratory
• 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.

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INDICATOR/EVIDENCE
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COMPLIED
Hdv:

REMARKS
_______
5. There is policy Document Review
/
and procedure • Written policy and procedure
for handling for handling complaints/client
complaints and feedback /
client feedback • Suggestion box visible to
clients /
• Forms for complaints/ client
feedback
• Records of complaints/ client
KIA initial
feedback and actions taken
II. HUMAN RESOURCE MANAGEMENT
A. STAFF RECRUITMENT, SELECTION, APPOINTMENT AND RESPONSIBILITIES
6. There is policy Document Review
and procedure • Written policies and
for hiring, procedures on hiring,
orientation and orientation and promotion of
promotion for all personnel at all levels
levels of
personnel!
7. There is policy Document Review
and procedure • Written policies and /
on continuing procedures for staff
program for staff development and training
development • Proof of training through
and training relevant certificates, memos,
written reports, budgetary
allocations

Interview
• Human Resources /
Management Officer/
Personnel Officer
8. There is policy Document Review
and procedure • Written policies and procedures
for discipline, on discipline, suspension,
suspensibn, demotion and termination of
demotion and personnel at all levels
termination of
personnel at all
levels

B. PERSONNEL
9. The duties and Document Review
responsibilities • Written job description or duties
shall be clearly and responsibilities of all
stated laboratory personnel
10. There is an Document Review
adequate • List of Personnel with
number of designation
qualified • Area of assignments indicated
personnel with in the posted work schedule
documented
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CR INDICATOR/EVIDENCE COMPLIED li
REMARKS
. _
training and signed and approved by head of
experience to laboratory
conduct/perform • There is a policy whenever
the laboratory there is an increase in X f/-» lf>r* Ol’cG.
procedures workload, there shall be a
corresponding increase in the f' l*''j
number of personnel
• There is a policy on hiring or
designating additional
personnel as:
• Proof of attendance
• Proof of qualifications
(please refer to specific
personnel)
• Authority to practice signed
by the head of the
government facility,
applicable (A.O, # 92 s.
if u/x
2003)
11.. Tfrdre is policy on Document Review
1he • Proof of submission of data to
implementation NDHRHIS
of National
Database of
Human Resource
for Health
Information
System
(NDHRIS)
12. Each personnel Document Review
shall have a • Updated 201 files of all
record of updated laboratory personnel
201 files
A. The Head of the Document Review
Laboratory • Proof of supervisory visits at
(HOL) shall least once a week for physical
have the overall visit OR once a month physical /
supervision on visit with at least twice a week
technical of supervisory calls and/or
procedures as video conferencing
well as on the
administrative
laboratory
• For HOL of hospital-based
clinical laboratory: supervisory
physical visits of at least once a
m
management week Vr • f^aH^iaur f('lfLOT&>
• Proof of qualifications:
X
nu> r-tfnt)
• Updated resume
• PRG-certificate and valid
J?RC ID
• PSP Board Certificate
• Certificate of Good Standing
from PSP
• Notarized employment
contract ________

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 5. Others
C. Biosafety and Document Review a .^ervetlrfa, 0^ot\
Biosecurity • PRC certificate and valid PRC
b. (j
Officer (May be ID(RMT)
designated by • Certificate of training in
the HOL) Biosafety and Biosecurity
(RUM and/or UP-NTCBB)
X
Staffing Pattern for RMT Analysts
1, Clinical Laboratory for Clinical and Anatomic Pathology
P RIMARY SECONDARY T ERTIARY
SERVICES 1*1 2nd 3rd 1st 2«d 3rd 1st 2^ 3rd
Shift Shift Shift Shift Shift Shift Shift Shift Shift
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
8(7+1 reliever) without 12(11+1 reliever)
Microbiology 12 (11+1 reliever) without Histopathology
Total 9 (8+1 reliever) for 13 (12+1 reliever) for
Government Facilities Hospital-Based
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

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CRITERA INDICATOR/EVIDENCE | COMPLIED i
Ail KS
____

III. PHY! . PLANT, FACILITIES, AND WORK ENVIRONMENT

13. There is Document Review
program of • Written policy and program for
proper the proper maintenance and
maintenance monitoring of physical plant and
and monitoring facilities /
of physical plant • Proposed schedule for
and facilities preventive maintenance

Observe
• Updated proof of actual
implementation of maintenance
as to structure, ventilation,
Hh initial
lighting & water supply
14. There are policy Document Review
guidelines on
laboratory
• Local risk assessment reviewed
at least annually
X
/
biosafety and • Written protocols on laboratory
biosecurity biosafety and biosecurity

Observe /
• Good Laboratory Practice that
includes use of Personal
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COMPLIED REMARK0 |||r

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• Relevant training certificates Qr. rptnt,
(e.g., Molecular Pathology)
* Annual medical certificate x r>.i
and proof of immunization
(HepajKis B and Influftriza)

Qualification of Head of Laboratory Certified CP Certified AP Remarks

A. Clinical Laboratory
1. Primary /
2. Secondary /
3. Tertiary /
4. Limited*
B. Anatomic Laboratory /
C. Molecular Laboratory
1. Genetics**
2. Immunohematology /
3. Infectious /
* It will depend on the limited services to be provided
**A pathologist or a licensed physidan who is trained in the management, prindples and methodology of these
specialized services that are being provided shall head this type of laboratory

CRITERIA
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':i-: Jik
B. Registered Document Review
Medical • Proof of qualifications:
Technologist • Updated resume
(RMT) • PRC certificate and valid l(H (Uniracf- Tf-
PRC ID
(At least 1 • Relevant training certificates
competent • Notarized employment « Fanor
RMT per contract
assigned area) • Annual medical certificate
• Proof of immunization
(Hepatitis B and Influenza)

RMT staff with

designated
assignments! as
Additional proof of trainings
KIA
applicable: |
♦ Certificate of proficiency
1. rHIVda (SACCL)
• Certificate of training on.DSSM
2. AFB microscopy
(NTRL)
• Certificate of training in
3. Bacteriology bacteriology (RITM and other
RITM recognized institutions)
• Certificate of training in malaria
4. Malaria smear
smear (RITM)_____________

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CRITERIA INDICATOR I EVIDENCE COMPLIED REMARKS

Protective Equipment and other

precautionary measures
15. There is a policy Document Review
and procedure • Policy on disposal of wastes
/
for the proper that conform with Healthcare
disposal of Waste Management Manual,
waste and and RA No. 6969
hazardous/infect • Notarized Memorandum of
ious substances Agreement (MOA) with -
that shall infectious waste, toxic, and
conform to the hazardous substances hauler
standards set by
the DOH Observe
• Proof of proper management of
wastes from point of generation,
segregation (color-coded waste
bins), disinfection, up to the f inal
disposal
NOTE: Please see the reference plan/physical plant (Annex D1 and D2)

IV. EQUIPMENT/INSTRUMENTS
16.Thereisan
adequate
number of
Document Review
• List of available and functional
laboratory equipment
7
operational
equipment to Observe
provide the • All laboratory equipment and
laboratory instruments are operational
examinations
that the
laboratory is
licensed for
17. There is Document Review
program for • Regular schedule including
calibration, frequency of preventive
preventive
maintenance
and repair for
maintenance and calibration
• Updated certificate of calibration
and maintenance of equipment
m initial
the equipment. • Record of repair reports
18. There is Document Review
contingency plan • Written policy on contingency
in case of plan in case of equipment
equipment breakdown
breakdown
;• (If1

V . REAGENTS AND SUPPLIES

19. There is an Document Review
adequate supply • Quality records of supplies
of properly /reagents with expiration date,
stored and their usage/ consumption and
inventoried disposal are available
pVr'A'd-c -taj CWctf-f
reagents and
supplies for the
• Certificate
Registration
of
from
Product
FDA
A
D OH-H FSRB-QOPOI-CLG-AT
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:at pence
CRITI
w!!ii^ ill! 11 . ';v'
F'
m-
=0„PUED REM ;
laboratory including the reagents, supplies,
examinations to and equipment used for ROOT
be provided. and MCL

Observe
• Availability and completeness
If C Uct fmW> 6^
of reagents and supplies
• Validate the expiration dates of
reagents
20. The reagehts Document Review
and supplies are • Records of temperature
stored under the monitoring as follows:
required • Room temperature reading
conditions with • Refrigerator and freezer
adequate temperature reading
storage facilities
such as Observe
refrigerators for • Monitoring of room temperature v/
perishable • Temperature of refrigerators (2°C
reagents and to 8°C) and freezers (-20<>C to -
supplies 30°C)
21. There is an Document Review
appropriate • Material Safety Data Sheet
storage (MSDS) available for all
area/technique reagents/supplies and
for flammable, accessible to all personnel at all
combustible and times
hazardous
chemical/reagen Observe
ts • Organized per section with
National Fire Protection
Association (NFPA) Label or its
equivalent
VI. ADMINISTRATIVE AND TECHNICAL POLICIES AND PROCEDURES :i.

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22. There is an Document Review

administrative • All documented policies,
policies & protocols, procedures are
procedures for signed and approved by the
provision of head of laboratory
laboratory • Guidelines in the operation and
services and for maintenance of the laboratory
the operation including policy on security of
and supplies. specimens and
maintenance of confidentiality of records
the laboratory • Laboratory services and
corresponding prices are
accessible to the public
23. The technical Document Review
procedures of • Documented and updated
services policies and procedures of
provided by laboratory services in each of
the sections/areas. _____

1)
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INDICATOR/EVIDENCE
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COMPLIED
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each section are • Documented policies, protocols,

available and guidelines in the operation
and maintenance of the
laboratory
A. Communication and Records
24. There are Document Review
procedures for the • Documented procedures for
receipt and receipt and performance of
performance of laboratory tests
laboratory tests
25. There are Document Review
procedures for • Documented procedures for
reporting of reporting of results of laboratory
results of tests
laboratory tests • Documented procedures for the
validation of laboratory results
prior to reporting
26. The laboratory Document Review
reports on • Laboratory report forms bearing
various
examinations of
the name and original/digital
signature with PRC ID No. of the
X pjvif
specimens: head of the laboratory and the
A. shall bear the RMT analysts
name of the • Updated records of result
pathologist or (logbooks/ electronically stored Nft ini'H*!
designated data with back up) including
associate entry, releasing & endorsement
who shall be records.
responsible • There is a policy guideline on
for the the use of authenticated
reliability of electronic/digital signature that
the results is in accordance with the E-
B. The reports commerce law
shall also
bear the
• Documented policy for Mini' Uf
Laboratory Information System,
name of the if available
RMT(s) who
performed the
examinations
and duly
signed by
that/those
person(s)
27. There are Document review
procedures for • Documented procedures for
reporting of reporting of workload, quality
workload, quality
control,
inventory
control, inventory control, etc.
• Updated reports and documents
(hard or soft copy with back up)
m mrfi«l
control, etc. • Worksheets/machine print out
per section as proof of actual
inrM
performance

DOH-H FSRB-QOP01 -CLG-AT

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' • R/EVIOSNCE ^ , *
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28. There is a Document review /
procedure for • Documented procedures for
reporting and reporting and analysis of
analysis of incidents, adverse events, etc.
incidents,
adverse events,
• Compiled of written reports with
resolutions
NA iml'H
and other
related process.
29. There is a Document review
documented • Documented procedure for the Updfijc kKc| </Vl
procedure on retention of records which X potf Ad
the retention of follows standards promulgated
documents, by the DOH
records, slides,
and specimens
• Compiled laboratory tests
results, whether logbook or
initial
of the clinical electronically stored
laboratory which
shall follow
standards
promulgated by
the DOH (DC#
70s. 1996)
and/or
competent
professional
organizations
B. Quality Assurance
30. There is a policy Document review
on Quality • Documented Internal QAP
Assurance including Internal Quality
Program (QAP) Control and Continuous Quality
and Continuous Improvement
Quality
Improvement
• Updated Quality Control reports
conducted per tests and filed NA wifi* I
accordingly
• Availability of reference
materials and appropriate
reagents & equipment used
• Results/findings of Quality inrfctl
Assurance audits / assessments

31. There is a proof Document review

of participation in • Documented procedure in the
External QAP actual performance of EQAP
(EQAP) that may activities
be administered • Certificate of Performance in inrtifl I
by a designated EQAP with passing rate
NA
NRL or other
local and
international
EQAP approved
by the DOH
C. Referral or Outsourcing of Laboratory Tests

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E INDICATOR/EVIDENCE COMPLIED —

32. There is a policy Document Review

on referral and • Documented procedures on /
outsourcing of referral and outsourcing of
examinations examinations to other DOH
licensed clinical laboratory
• Records of outsourced
examinations (in the event of
machine breakdown)
• Notarized Memorandum of v/
Agreement
• DOH-LTO of referral testing SCO
laboratory
V, po,^c„hs,poct,
__________
33. There is a policy Document Review
on POCT • Documented list of POCT
operators, machines,
instruments and kits
• Documented procedure on the
conduct of periodic assessment
by representatives from the top
management, clinical
laboratory, clinical departments
and nursing service, to evaluate
the policy of the clinical

mm
laboratory on POCT

™ M0BILECLINICAI- LABORATORY
34. There is a policy Document Review
w- ■ i#! ms
on Mobile Clinical • Documented Procedures on
Laboratory • Collection of specimens
* Processing of specimens
• Land Transportation Office
Registration (proof of
ownership)
• File of Memorandum of
Agreement between the clinical
laboratory and the facility where
the mobile activity is conducted

DOH-HFSRB-QOP01-CLG-AT
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& Republic of the Philippines

%
•I Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Facility: Myiw-m cwkjio

Date of Inspection: (if

RECOMMENDATIONS:
For Licensing Process

[ ] For Issuance of License to Operate as:

Valid ity from _________________ to

Issuance depends upon compliance to the recommendations given and submission of the
following within •miim C3o) days from the date of inspection.

[ 1 Non-issuance.

Specify reason/s:

Inspected by: pftvii otm u jr

Printed Name

iW
a
Signature Position/Designalion

ia frr

Received by:
&
Signature:
Printed Name: OylUPfl S'0/liAuiTH
Position/Designation:

Date: oi\ ^U'b

DOH-HFSRB-OOPOI-CLG-AT
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