A.0.No.

2021-_(pH37
ANNEX B1
Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL LABORATORY

INSTRUCTIONS:
1. To properly filloutthis tool, the Licensing Officer shall make use of: INTERVIEWS, REVIEW OF DOCUMENTS,
OBSERVATIONS and VALIDATION of findings.
. If the corresponding items are present, available or adequate, place a
NN

(+) on each of the appropriate spaces

under the COMPLIED column or space provided alongside each corresponding item. if not, put an (X) instead.
. The REMARKS column shall document relevant observations.
hw

. Make sure to fill-in the blanks with the needed information. Do not leave any items blank. Put N/A if Not
Applicable.
. The Team Leader shall ensure that all team members write down their printed names, designation and affix
DO
their signatures and indicate the date of inspection/monitoring, all at the last page of the tod.
. 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 received. also

GENERAL INFORMATION:
Name of Facility:

Complete Address:
Number& Street
Barangay/District

Municipality/City Province/Region

Contact Information: E-mail Address:

Initial [ 1 Renewal [ 1

Existing License
Number: Date Issued:
. ;
Expiry Date:.

Name of Owner or Governing Body (if corporation):

Name of Head of Laboratory:

Classification According to:
Ownership: O Government O Private
Function: 0 Clinical Pathology O Anatomic Pathology
O Molecular Laboratory

Institutional-Character: OO Non-Institution Based

OQ
Institution-based
Specify Institution:
0 DOH Based Program

7
Service Capability 0 Primary
Laboratory
Secondary O Limited-Service Capability

0 Tertiary O Mobile Clinical

DOH-HFSRB-QOP01-CLG-AT
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F
i
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bE
CRITERIA
cof

“ORGANIZATION AND MANAGEMENT

i
: INDICATOR/EVIDENCE |compLien|
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. Thereis 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
¢ DOH-LTO posted in a
Valid
conspicuous area visible to
clients
4. There is a policy Document Review
and procedure + Written policy on management
on management review
review e Compilation of documented
minutes of meeting reflecting
the date, time, attendance,
agenda, and action taken
signed and approved by head of
laboratory
e Supporting documents for
evaluation and monitoring of
activities such as records,
logbooks, checklist of supplies,
inspection report, purchasing or
procurement and acceptance of

A)
supplies, etc.

DOH-HFSRB-QOP01-CLG-AT
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Page 2 of 13
t
CRITERIA’ Fo COMPLIED|
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
e Forms for complaints/ client
feedback
¢ Records of complaints/ client
feedback and actions taken
ll. HUMAN RESOURCE MANAGEMENT
A. STAFF RECRUITMENT, SELECTION, APPOINTMENT AND RESPONSIBILITIES
6. There is policy Document Review
and procedure o 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,
suspension, 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. Thereis an Document Review
adequate eo List of Personnel with
number of designation
qualified * Area of assignments indicated
personnel with in the posted work schedule
documented
DOH-HFSRB-QCP01-CLG-AT
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Eo :
© REMARKS.
LT

£
“CRITERIA Je INDICATOR/EVIDENCE COMPLIED
F

training and signed and approved by head of

experience to laboratory
conduct/perform eoThere is a policy whenever
the laboratory there is an increase in
procedures workload, there shall be a
corresponding increase in the
number of personnel
e 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, ff

applicable (A.O. # 92 s.
2003)
11. There is policy on Document Review
the » Proof of submission of datato
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 o Proof of supervisory visits at
(HOL) shall least once a week for physica
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 e For HOL of hospital-based
administrative clinical laboratory: supervisory
laboratory physical visits of at least once a
management week
» Proof of qualifications:
+
Updated resume
+
PRC certificate and valid
PRC ID
+
PSP Board Certificate
+
Certificate of Good Standing
from PSP
+
Notarized employment
contract

DOH-HFSRB-QOP01-CLG-AT
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_|
CRITERIA

Qualification of Head of
A. Clinical
~

| INDICATOR/EVIDENCE
»

«
Relevant training certificates
(e.g., Molecular Pathology)
Annual medical certificate
and proof of immunization
(Hepatitis B and Influenza)

Certified CP
~~

| COMPLIED

Certified AP
~~ REMARKS

Remarks

1. Prim /
2. /
37
4. Limited*
/

B. Anatomic
C. Molecular
1. Genetics**
2. Immunohem
3. Infectious
* It
depend on the limited services to be provided
will
**A pathologist or a licensed physician who is trained in the management, principles and methodology of these
specialized services that are being provided shall head this type of laboratory

EE
[A
i

B.
CRITERIA

Registered
Medical
INDICATOR/EVIDENCE

Document Review
¢ Proof of qualifications:
| COMPLIED T— ~~ "REMARKS

Technologist »
Updated resume
(RMT) * PRC certificate and valid
PRC ID
(At least 1 + Relevant training certificates
competent » Notarized employment
RMT per contract
assigned area) «Annual medical certificate
«Proof of immunization
(Hepatitis B and Influenza)

staff with

.
RMT
designated
assignments, as
os
Additional proof of trainings
applicable:
1. rHIVda
o
ane) of proficiency

2. AFB microscopy|
3. Bacteriology
*
TRL of training on DSSM
o Certificate of training in
bacteriology (RITM and other
RITM recognized institutions)
¢ Certificate of training in malaria

4)
4. Malaria smear
smear (RITM)

DOH-HF SRB-QOP01-CLG-AT
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 5. Others
C. Biosafety and Document Review
Biosecurity o PRC certificate and valid PRC
Officer (May be ID (RMT)
designated by o Certificate of training in
the HOL) Biosafety and Biosecurity
(RITM and/or UP-NTCBB)

Staffing Pattern for RMT Analysts

1. Clinical Laboratory for Clinical and Anatomic Pathology
PRIMARY SECONDARY TERTIARY
SERVICES 4st ond ard {st ond 3rd qst ond 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 without Histopathology
Total 9 (8+1 reliever) for
12 (11+1 reliever)
13 (12+1 reliever) for
Govemment 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

"

CRITERIA INDICATOR / EVIDENCE COMPLIED REMARKS

II. PHYSICAL PLANT, FACILITIES, AND WORK ENVIRONMENT

13. Thereis 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 e Proposed schedule for
and facilities preventive maintenance

Observe
» Updated proof of actual
implementation of maintenance
as to structure, ventilation,
lighting & water supply
14. There are policy Document Review
guidelines on ¢ Local risk assessment reviewed
laboratory at least annually
biosafety and ¢ Written protocols on laboratory
biosecurity biosafety and biosecurity
Observe
¢ Good Laboratory Practice that
includes use of Personal
DOH-HF SRB-QOP01-CLG-AT
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Page 6 of 13
CRITERIA ~

15. There is a policy

and procedure
for the proper
INDICATOR/ EVIDENCE
- Protective

Document Review
and other
Eq uipment
precautionary measures
* Policy on disposal of wastes
that conform with Healthcare
COMPLIED REMARKS
|
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
conformto 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 fina
disposal
NOTE: Please see the reference plan/physical plant (Annex D1 and D2)
IV. EQUIPMENT /INSTRUMENTS
16. There is an Document Review
adequate o List of available and functional
number of laboratory equipment
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 calibration
maintenance * Updated certificate of calibration
and repair for and maintenance of equipment
the equipment. ¢ Record of repair reports
18. There is Document Review
contingency plan e« Written policy on contingency
in case of plan in case of equipment
equipment breakdown
breakdown
V. REAGENTS AND SUPPLIES
19. There is an Document Review
adequate supply Quality records of supplies
of properly Ireagents with expiration date,
stored and their usage/ consumption and
inventoried disposal are available
reagents and s Certificate of Product
supplies for the Registration from FDA,

“77 DOH-HFSRB-QOP01-CLG-AT
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Page 7 of 13
 CRITERIA

laboratory —
examinations to
be provided.
| ¢
INDICATOR/EVIDENCE
“including the reagents, supplies,
and equipment used for POCT
and MCL

Observe
Availability and completeness
of reagents and supplies
~|COMPLIED
—
|

~~ REMARKS
—

e Validate the expiration dates of

reagents
20. The reagents 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 e Monitoring of room temperature
perishable » Temperature of refrigerators (2°C
reagents and to 8°C) and freezers (-20°C to -
supplies 30°C)
21.Thereis an Document Review
appropriate eo 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 e Organized per section with
National Fire Protection
Association (NFPA) Label or its
equivalent
VI. ADMINISTRATIVE AND TECHNICAL POLICIES AND PROCEDURES
22. There is an Document Review
administrative eo 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 e Laboratory services and
corresponding prices are
accessible to the public
23. The technical Document Review
procedures of e Documented and updated
services policies and procedures of
provided by laboratory services in each of
the sections/areas.
DOH-HFSRB-QOP01-CLG-AT
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Page 8 of 13
 CRITERIA
each section are
available
ICE
Documented policies, protocols,
and guidelines in the operation
| COMPLIED |. *.REM

=~
and maintenance of the
laboratory
A. Communication and Records
24. There are Document Review
procedures forthe] « 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
eo

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 the name and original/digita
examinations of signature with PRC ID No. of the
specimens: head of the laboratory and the
A. shall bear the RMT analysts
name of the o Updated records of result
pathologist or (logbooks/ electronically stored
designated data with back up) including
associate entry, releasing & endorsement
who shall be records.
responsible e 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 ¢ Documented policy for
bear the 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 e Documented procedures for
reporting of reporting of workload, quality
workload, quality control, inventory control, etc.
control, Updated reports and documents
inventory (hard or soft copy with back up)
control, etc. Worksheets/machine print out
per section as proof of actual
performance

DOH-HFSRB-QOP01-CLG-AT
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28. There is a Document review
procedure for e¢ Documented procedures for
reporting and reporting and analysis of
analysis of incidents, adverse events, etc.
incidents, e Compiled of written reports with
adverse events, resolutions
and other
related process.
29. There is a Document review
documented e Documented procedure for the
procedure on retention of records which
the retention of follows standards promulgated
documents, by the DOH
records, slides, e Compiled laboratory tests
and specimens results, whether logbook or
of the clinical electronically stored
laboratory which
shall follow
standards
promulgated by
the DOH (DC#
70 s. 1996)
and/or
competent
professional
organizations
B. Quality Assurance
30. There is a policy Document review
on Quality e Documented Internal QAP
Assurance including Internal Quality
Program (QAP) Control and Continuous Quality
and Continuous Improvement
Quality « Updated Quality Control reports
Improvement conducted per tests and filed
accordingly
e Availability of reference
materials and appropriate
reagents & equipment used
¢ Resultsffindings of Quality
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 e Certificate of Performance in
by a designated EQAP with passing rate
NRL or other

4
local and
international
EQAP approved
by the DOH
C. Referral or Outsourcing of Laboratory Tests g

DOH-HFSRB-QOP01-CLG-AT
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Page 10 of 13
32. There is a policy
on referral and
-
Document Review
¢ Documented procedures on
|.
COMPLIED

outsourcing of referral and outsourcing of

examinations examinations to other DOH
licensed clinical laboratory
* Records of outsourced
examinations (in the event of
machine breakdown)
oe Notarized Memorandum of
Agreement
e DOH-LTO of referral testing
Laboratory
vi. POINT oF CARE TESTING(PoC)
33. Thereisa ‘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
laboratory on POCT _
VIII. MOBILE CLINICAL LABORATORY

34. Thereisa policy Document Review

on Mobile Clinical ¢ Documented Procedures on
Laboratory » Collection of specimens
+
Processing of specimens
e Land Transportation Office
Registration (proof of
ownership)
e File of Memorandum of

A
Agreement between the clinical
laboratory and the facility where
the mobile activity is conducted

DOH-HFSRB-QOPO1-CLG-AT
Revision: 00
1 2021
Page 11 of 13
 Republic of the Philippines
. Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Facility:

Date of Inspection:

RECOMMENDATIONS:
For Licensing Process

[1 For Issuance of License to Operate as:

Validity from to

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

[1 Non-issuance.

Specify reason/s:

Inspected by:
Printed Name Signature Position/Designation

Received by:

Signature:
Printed Name:
Position/Designation:
Date:

DOH-HF SRB-QOP01-CLG-AT
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Page 120f 13
 Republic of the Philippines
2 Department of Health
>/ HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Facility:

Date of Monitoring:

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

[1 Non-issuance of Notice of Violation.

[1 Others. Specify:

Monitored by:
Printed Name Signature Position/Designation

Received by:

Signature:
Printed Name:
Position/Designation:
Date:

DOH-HFSRB-QOPO1-CLG-AT
Revision: 00
7142021
Page 130f 13
 A.O.No.2021- 0037
Republic of the Philippines ANNEX B2
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

EQUIPMENT/INSTRUMENTS/GLASSWARE/SUPPLIES/REAGENTS PER AREA OF ACTIVITY/SERVICE

CAPABILITY OF GENERAL CLINICAL LABORATORY (Place a von spaces provided before each item if available

|
and X if not; or NA for Not Applicable)

ACTIVITY SERVICES | GLASSWARE AND SUPPLIES

70% Alcohol
Cottons
___
___ Tourniquet
| ~~ REMARKS ~~
Lancet
Blood ___ Capillary Tubes
Extraction ___ Labeling Materials
___Test Tubes
Sterile Medical tape
__
SPECIMEN __ Syringe and Needle-any gauge
(Expiration Date)
COLLECTION ___
Puncture Proof Sharps Container

___ Applicator Stick

container w/ cover or
Other Body __ Specimen
Screw Cap (50mL)
Fluids (Urine,
Stool, Sputum, Sterile Screw Cap Specimen
__
etc.) Container, if applicable
___
Plastic calibrated loop and other
necessary materials, if applicable
__Non-Mercurial Thermometer: (Room
and storage refrigerator)

OTHER __ Refrigerator (samples/reagents)

EQUIPMENT Fire Extinguisher (Class B)
___

___
Spill Kits

aEAR
EQUIPMENT /
SERVICES INSTRUMENT / REAGENTS. ot
GLASSWARE/SUPPLIES
Clinical Microscopy
Supplies
Slides
__ Test tubes (10ml)
___
___
Cover Slips
__ Test Tube
Applicator
Rack
sticks Urine Strips
___
__4- parameter
Manual __
10 - parameter
URINALYSIS __
Clinical Centrifuge (2,000
pm) Control/s
__ Microscope (Binocular Normal
Compound) ___ Pathologic

1
__ Automated
__ Strip Reader
___
Urine Analyzer
DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/11/2021
Page 1 of 6
 EQUIPMENT /
REAGENT/S REMARKS
SERVICES INSTRUMENT /
GLASSWARE/SUPPLIES Mo <'Exeim (Quality improvement)

WET SMEAR FOR Supplies

Trichomonas ___Slides
___ Test tubes (10m)
___Cover Slips ___ Normal Saline
__ Test Tube Rack
Solution
___ Applicator sticks
Lugol's lodine
STOOL ANALYSIS __
__ Microscope (Binocular
Compound)

PREGNANCY TEST
__ Pregnancy test kit
FECAL OCCULT
___ Occult blood test kit
.

BLOOD
Special Tests: For Indicate the Test
DOH identified
endemic areas
only(e.g., Kato Katz,
Schistosomiasis,
Malaria smear, Filaria
smear, slit-skin
smear, rapid plasma
regain for syphilis)
Hematology

__ Manual __ Hemoglobin
___Spectrophotometer or
its Reagent (Cyanmet
HEMOGLOBIN equivalent Hemoglobin)
__ Cuvettes/test tubes
___ Sahli/micropipette ___ Standard

__ Manual
___ Hematocrit Centrifuge
HEMATOCRIT ___ Hematocrit Reader
___ Capillary Tube
___ Sealer

RED BLOOD CELLS __ Manual RBC Diluent

__ Other
__ Microscope ___ reagent
(Optional) (Binocular Compound)
Pipette Shaker
__ Tally
___ Counter
WHITE BLOOD ___WBC Diluent
___
RBC / micropipette
CELLS
___ Counting Chamber w/
Cover Slips
PLATELET COUNT
___ WBC micropipette Platelet Diluent
(Quantitative)
___ Petri Dish (as applicable)
__
__ Manual
__ Differential Counter

1
DIFFERENTIAL __ Hematology
Slides
COUNT __ Glasses
Staining Kit
___ Staining Oil immersion
___
___ Microscope
(Binocular Compound)

DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/44/2021
Page 20of 6
 EQUIPMENT /
SERVICES INSTRUMENT / REAGENT/S REMARKS
.

GLASSWARE/SUPPLIES ™ ke Note of Expl

pi (Quality
Quality Improvement) )
mp

Diluents
__
__Lyse
__ Cleanse
Other
Solution
Reagents
COMPLETE BLOOD
COUNT
__ Automated _.
___ Hematology Analyzer
Controls
___ Low
___ Normal
High

__ Serofuge its equivalent

or

— Test Tubes __ Normal Saline

FORWARD AND
REVERSE ABO _ Manual Solution
__ Gel-type based
blood typing
:

GROUPING AND Rh
(D) TYPING (Tube __ Semi-automated machine reagents
Blood Typing
;

M ethod) ___
Sera
__ Automated

Additional Services for Secondary Category

COAGULATION Coagulation Machine
___ __ Coagulation
STUDIES for- ___
Calibrated Pipettes Reagents
hospital-based __ Cuvettes or its equivalent ___
Controls

Clinical Chemistry
__ Refrigerator (sample and
reagents)
Clinical Centrifuge __ Distilled Water
__ Standard/
__ Water Bath
or
its equivalent Calibrator

ROUTINE: __ Calibrated Pipettes Controls

Blood Glucose (Bs / — Pipette tips — Normal

__— omer,
RBS /OGTT) Other Pipettes __ Pathologic
Total Cholesterol
Triglycerides
HDL. y
Luvelles
TestReagents
__ Test Tubes
Blood Uric Acid __ Test Tubes Rack — Total Cholesterol
Blood Creatinine
__ Triglycerides
Blood Urea __ HDL
Nitrogen
___ Manual
Spectrophotometer or its
__
Uric Acid

-
— Creatinine
equivalent

Automated __ Oral Glucose

—_—
Tolerance Drink
__ Chemistry Analyzer
Additional Services for Secondary Category
__Standard/
Manual Calibrator
__
ELECTOLYTES (Na,
K, Cl) Controls
__ Automated Analyzer __ Normal
___ Pathologic

DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/11/2021
Page 3 of 6
 SERVICES
EQUIPMENT
INSTRUMENT /
GLASSWARE/SUPPLIES
.
/ (Te
REAGENT/S
Note
Take Note ofExim)
Expl
of
REMARKS
(Quality
Quality | Improvement)t

___
Test Reagents
—
a
AST
ALT
— AST
_ALT
Additional Services for Tertiary Category
Other Clinical ___Standard/
Chemistry Calibrator
Examinations — Manual
Controls
ARTERIAL BLOOD
__ Automated Analyzer — Potharogic
GASES (ABG) — for {indicate the name
of machine)
hospital-based
__ Test Reagents
Immunology / Serology
__ Cuvettes
__ Test Tubes
__ Test Tubes Rack __ Standard/

pi
if
Glass Pipettes Calibrator,
; applicable
pp
— Pipettes Pipette tips
:
&
BASIC SEROLOGIC
TESTING using
Rapid Test Kits — __ Rapid test kits
, . Controls, if
aoplicable
Pp
i” B,
Dengue, Hepatitis — Dengue
.
Syphilis, HIV ___ Syphilis
Hepatitis B (screening)
__ Normal
raed
— Pathologi

__ Test Reagents, if
HIV (screening)
—
applicable
__ Microscope or agglutination
viewer
Additional Services for Tertiary Category
Distilled Water
__
__ Standard/
Calibrator
__ Automated Analyzer
MACHINE-BASED (Indicate the of machine)
name Controls
SEROLOGICAL Normal
AND —_ Pathologic
IMMUNOLOGICAL — Manual
TESTING __Spectrophotometer or its
equivalent Test Reagents
__ Tumor Markers
___ Thyroid Function
Hepatitis Profile

ri
___

Microbiology
__ Microscope
(Binocular Compound)
__ Staining Rack

EARfor
TB DIRECT or Electric

__ Isolation Hood with exhaust __ Acid-Fast Bacilli

MICROSCOPY
government
facilities
an hy
(Improvised)
(

Sod
Timer
__ Slides
__ Cover Slips
Inoculating Loops 2
DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/11/2021
Page 4 of 6
 EQUIPMENT /
SERVICES INSTRUMENT / REAGENT/S REMARKS
,

GLASSWARE/SUPPLIES (Teteake Note of Expl orexeim

(Quality Improvement)

__ Applicator Sticks
__ Forceps
NUCLEIC ACID
AMPLIFICATION
Tha kits for
.

TEST (NAAT) for NAAT for TB

__
government
facilities
Additional Services for Secondary Category
KOH
— 10%
Centrifuge KOH

GRAM STAIN __ Refrigerator

__ Gram’s stain
kit

Additional Services for Tertiary Category

Culture Media:
__ Biosafety cabinet
Type A with certification)
(Class Ii __BHI
__MAC __CAP
BAP
_
__ Incubator
__ Drying Oven
__GBA
__SSA _ TSA
_
BCA

__ Autoclave
__ Weighing Scale
__MHA
__SFB _ TSBAPW
__ Water Bath __TCBS
__ Table Lamp ___Thio broth
__ Electric/Gas Stove
__ Refrigerator with freezer
_ MHA w/ 5%
sheep Blood

__ Sterile Swabs __ Biochemical

CULTURE AND __ Candle Jar Reaction (Conventional
SENSITIVITY (aerobic __Caliper/Ruler Method/
Graduated Cylinder Commercially Prepared)
and anaerobic) ___
__ Beaker
___ Erlenmeyer flask __ Sensitivity
Disk/Antimicrobial
__Petridish Disk
__ Glass Pipettes
___
Calibrated Inoculating Loops
__ Laboratory Thermometer __ Mac Farland
Standard (0.5)
__ Automated System / Control Strains
Blood Automated Card
System (ATCC):
(Indicate the name of machine) __ Pseudomonas
aeroginosa
___ Staphylococcus
aureus
__ Escherichia coli
Anatomic Pathology
For Secondary Catego ry

__ Microscope
(Binocular Compound)

__ Timer
PAP SMEAR __ Slides __ Papanicolaou
__ Cover Slips stain
__ Adhesive its equivalent
or

__ Forceps

0)
__ Staining Glasses

DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/11/2021
Page 50f 6
 EES
PATHOLOGY

CYTOLOGY

FROZEN SECTION,
if applicable
|
Additional Services for Tertiary Category

SURGICAL
~ Paraffin
- Microtome

Srosammatic

___
__
__
__
Oven

Cryostat
gs
EQUIPMENT /

__ Manual Technique
__ Water Bath
ontissue

Block holder

Ruler
Autopsy Table
Bone Saw
—
Toriatom
Formalin
___
Paraffin wax
Xylene
__ Chloroform
— Benzene
— loluene
___Carbon
tetrachloride
Hematoxylin
Eosin Stain
__Alcohol (50%,
80% 90%, 100%)
__Isopentane
Foe ematoxylin
Alcohol
(70%, 80%, 90%)
&

70%,

&
cameron

AUTOPSY, if __ Scalpel
applicable __ Scissors
Rib Shears
__
Toothed Forceps
__
__ Weighing Scale
Molecular Pathology
__ Water
Distilled
Indicate Services __Standard/
___
Clinical Centrifuge Calibrator
__ Refrigerator
Controls
__PCR __ Normal
___
Other Machines/Equipment/ __ Pathologic
Supplies

Test Reagents

"J
Note: These are the list of minimum requirements as to equipment, reagents/culture media,
supplies & glassware’s. Additional services are acceptable provided that appropriate items
mentioned with technical procedures, spa rsonnel are available, if necessary. (Please
use additional sheet of paper, if needed.)

DOH-HFSRB-CLG-AT AnnexB2
Revision: 00

et 6of6
44/2021
NOTE: This list is from RITM BRMO and not from DOH-MMCHD-RLED, for any clarifications with regard
to the contents of this spill kit kindly contact: brmo@ritm.gov.ph/ plebeian.medina@ritm.gov.ph

RITM BRMO
Biological Spill Response Guide and Clean Up Procedures

Biological spill response kit must contain the following:

Spill kit contents Quantity
Disinfectant
Concentrated Bleach 500 mL
Working dilution 1:10 dilution of bleach (freshly prepared)
70% Alcohol 500 mL
Disinfectant Bottle Container with clean water 2L
Hand Sanitizer (Sterillium) 1000mL
Personal Protective Equipment
Disposable Gowns (fluid resistant, long sleeves, back enclosure) 2 pieces
Gloves – Nitrile 8 pairs
Disposable shoe covers 2 pairs
N-95 respirator 2 pieces
Full face shield that fits over N-95 respirator 2 pieces
Towels (optional) 4 pieces
Absorbent paper towels 1 pack
Small disposable broom with dustpan 1 piece
Wiper 1 piece
Plastic tie 2 piece
Steel Tongs Large 1 piece
Forceps for sharps 1 piece
Sharps container 1 piece
Biohazard/Autoclave bags – Large 1 piece
Biohazard/Autoclave bags – Small 1 piece
Laminated copy of (SOP) spill response and cleanup procedures 1 piece
Laminated copy of Spill Kit Check List 1 piece
Zip bag container 1 piece
Signage “Do not Enter!” 1 piece

Spill Response

 Do not panic. Stay calm.

 Alert the people. Inform the people about the spill incident and the immediate area of spill.
 Remove contaminated clothing and wash affected area with water and soap (if applicable)
 Perform hand hygiene.
 Leave area of spill (evacuate).
 Close the area, post a “DO NOT ENTER !” sign, and allow agents to settle (at least 30 minutes)
 Identify the hazards and review the agent’s specific issues with the immediate supervisor, biosafety
officer and/or experienced colleagues.
 Assess the degree of contamination and formulate a plan for the action required
 Initiate clean-up as soon as possible.
Spill Clean Up Procedures

1. Don shoe covers, gloves, gowns, N-95 (if applicable), mask, full covered face shield.
2. Prepare 1:10 dilution of bleach.
3. Cover the spill with paper towels or other absorbent material, starting at the edges and working toward
the center of the spill.
4. Carefully pour disinfectant over the absorbent material and spill starting around the edges and working
toward the center. Saturate the area with the disinfectant.
5. Allow sufficient contact time for the disinfectant to inactivate all material in the spill; non-viscous spills,
15-20 minutes, viscous spill, 30 minutes disinfection.
6. Use tongs/forceps to pick up sharp objects (broken glass sharps, etc.) that may puncture gloves.
7. Wipe up spill using paper towels / absorbent materials and tongs/forceps. Work from the edges to the
center.
8. Discard absorbent material in biohazard waste bag as you clean-up the spill.
9. Clean the spill area with fresh absorbent material soaked in disinfectant. Thoroughly wet the spill area
and allow disinfecting for approximately 15-20 minutes.
10. Discard cleanup materials in biohazard bag, along with any contaminated PPE.
11. Close and secure bag, then place bag in second biohazard bag. Secure outer bag and disinfect by
autoclaving (steam sterilization).
12. Prepare written report about the incident and coordinate with the biosafety officer or the supervisor
for immediate medical attention and further evaluation / surveillance.