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AO2021-0066 Guidelines On The Issuance of Certificate On Inclusion (COI) in The Blood Services Network (BSN)
AO2021-0066 Guidelines On The Issuance of Certificate On Inclusion (COI) in The Blood Services Network (BSN)
Department of Health
OFFICE OF THE SECRETARY
DEC 23 201
ADMINISTRATIVE ORDER
No. 2021 - _0066
BACKGROUND
Pursuant to Section 2. Declaration of Policy of the Republic Act (RA) No. 7719
entitled “National Blood Services Act of 1994”, the Department of Health (DOH) is
mandated to establish and organize a National Blood Transfusion Services Network to
rationalize and improve the provision of adequate and safe supply of blood and blood
products.
Blood Centers (BCs) and other Blood Service Facilities (BSFs) nationwide are
organized into Blood Services Networks (BSNs), wherein each is designed to adapt to
the unique situation of their localities adhering to the existing standards of the National
Voluntary Blood Services Program (NVBSP). The NVBSP in line with the provisions
of RA No. 11223 or the “Universal Health Care (UHC) Act” and its Implementing
Rules and Regulations (IRR), aims to ensure equitable access to safe and quality blood
and blood products, and efficient blood service delivery to province-wide and city-wide
health systems (P/CWHS) by effective regulation of BSNs.
To attain an efficient and effective BSN that will provide timely access to safe
blood and blood products, all BSFs shall secure the required COI. Hence, this policy
shall provide the guidelines for the issuance of COI to
all BSFs in the country.
IL OBJECTIVES
This Order aims to provide the revised guidelines on the issuance of COI to
ensure adequate and accessible supply of safe blood and blood products within their
geographical area, and that all BSFs included in the BSN are continuously compliant
with the COI requirements and all other related policies, guidelines, and standards set
J
by the DOH.
Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 8651-7800 local 1108, 1111, 1112, 1113
Direct Line: 8711-9502; 8711-9503 Fax: 8743-1829 & URL: htip://www.doh.gov.ph; e-mail: fiduque@doh.gov.ph
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IIL SCOPE OF APPLICATION
This Order shall apply to all publicly and privately-owned BSFs as well as end-
user non-hospital based health facilities.
DOH Center for Health Development (DOH CHD) - Regional Voluntary Blood
Services Program (RVBSP) — refers to the regional counterpart or field
representative of NVBSP in the CHDs in implementing the Program’s policies,
coordination of core activities such as promotion of voluntary blood donation,
public education and advocacy, rationalization of BSFs with functional BSN, and
effective and equitable collection and distribution of blood and other resources.
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H. Lead Blood Service Facility (LBSF) — refers to a hospital or non-hospital based
BSF designated by NVBSP within the BSN. They may be Blood Centers (BCs) and
Hospital Blood Banks (HBBs) that are authorized to collect, test, and process blood
in the region or zone. The lead BSF oversees the satellite BSF within its zone.
J. Satellite BSF — refers to a blood service facility that is a member of a zonal BSN
and is monitored by the LBSF.
GENERAL GUIDELINES
A. All BSFs from the zonal BSN shall secure a COI as a prerequisite for the issuance
of DOH-LTO.
B. The application process shall be aided by the use of a checklist that follows the
utilization and implementation of the NVBSP Manual of Standards:
1. Manual of Standards for BSFs
2. Manual on Donor Recruitment and Counselling
3. Philippine Clinical Practice Guidelines (CPGs) for the Rational Use of Blood
and Blood Products and Strategies for Implementation
C. In case that the assessment of both the LBSF and the Regional Blood Program
Coordinator (RBPC) results in the downgrading of the blood service category of the
applicant BSF, the procedure for Renewal of COI shall be followed.
E. The overall processing of COI shall be done by the DOH CHD in coordination with
the LBSF. The processing time for the issuance of COI application shall be twenty
(20) working days upon receipt of complete documentary requirements.
F. The validity period of the COI shall be synchronized with the validity period of
their LTO (January to December of the following year). Application for issuance of
COI shall start in the 3rd quarter of the year (July of the current year) to provide
ample time for the BSF to prepare the required documents, and for the LBSF to plan
the schedule for physical inspection.
G. All BSFs (hospital and non-hospital based) shall renew their COI annually. The
COl reference number shall be presented in the next renewal of DOH-LTO as proof
of compliance and participation in the network.
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7
clinical laboratory. One may enter a Memorandum of Agreement (MOA) as stated
in AO No. 2012-0001 entitled, “New Rules and Regulations Governing the
Licensure and Regulation of Dialysis Facilities in the Philippines.”
I. A functional and active HBTC is a prerequisite for the issuance of the COI,
licensing of a hospital by the DOH, and accreditation by the Philippine Health
Insurance Corporation (PhilHealth).
J. The DOH CHD shall issue the COI for the following BSFs that are fully compliant
to the requirements set by DOH NVBSP:
1. Participating members of the BSN within their region that are monitored by the
LBSF and RBPC using the monitoring tool checklist (Annexes B or C).
2. LBSFs that are monitored by the RBPC using the same checklist (Annex C)
based on existing monitoring schemes.
K. The DOH CHD shall submit to the DOH NVBSP the final list of BSFs issued with
COI (on or before September 01 of the current year). The DOH NVBSP shall
annually (on or before October 1 of the current year) consolidate and endorse the
final list of BSFs with their corresponding BSF category for COI to the DOH Health
Facilities and Services Regulatory Bureau (HFSRB).
VL SPECIFIC GUIDELINES
1. The BSF shall submit a Letter of Intent (LOI) for application for COI addressed
to the DOH CHD Director, attention to the Regional Blood Program
Coordinator (RBPC).
2. The DOH CHD shall notify the applicant BSF for the designated LBSF and its
BSN.
3. The applicant BSF shall closely coordinate with the LBSF for the processing of
documentary requirements listed in Annex B: Requirements for Initial
Application of COL
4. The LBSF shall be responsible for the orientation of their zonal BSN about the
MOA provisions.
5. The LBSF shall check and assess the application documents (Annex B).
Incomplete application documents shall not be accepted or processed.
MY 4
a. Once approved, DOH NVBSP shall submit a Letter of Approval to the DOH
CHD’s Regional Voluntary Blood Services Program (RVBSP).
b. DOH NVBSP shall provide a copy of the Letter of Approval to HFSRB.
C. Renewal of COI
1. The satellite BSF shall submit an LOI to the Head of the LBSF for the
recommendation of renewal of COI together with the requirements listed in
Annex C: Requirements for Renewal of Application.
2. The LBSF shall check and assess the application documents (Annex C).
Incomplete application documents shall not be accepted or processed.
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b. The LBSF shall submit the final list of the BSFs within the zonal BSN
together with the duly accomplished checklist on the Application of COI,
recommendation letter, and its supporting documents signed by the LBSF.
c. All documents to be endorsed shall be addressed to the CHD Regional
Director, attention to the RBPC. The LBSF shall be responsible for the
transmittal of documentary requirements to the DOH CHD.
Sn
Final review of documents shall be done by the RBPC.
The CHD Director shall issue COI upon recommendation of the RBPC.
Signatory of the COI in theBSN:
a. The certificate shall be initialed by the RBPC and approved by the CHD
Director
b. The standard template of the COI (Annex E) shall be issued by the DOH
CHD.
Once the COI is issued to the applicant BSF, the BSF shall be referred to as
satellite BSF.
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1
d. If the BSF utilized and implemented the NVBSP’s Manual of Standards.
3. Recommend to the DOH NVBSP the upgrading of BSF and application for BC
and HBB+ following the rationalization plan of BSF by the CHD.
This Order shall repeal DM No. 2016-0448 entitled “Guidelines on the Issuance
of Certificate of Inclusion to Blood Services Network”, dated14 December 2016 and
all other issuances inconsistent with this Order.
EFFECTIVITY
This Order shall take effect fifteen (15) days after its publication in the Official
Gazette or in any national newspaper of general circulation, with three (3) certified
copies to be filed with the Office of the National Administrative Register (ONAR) of
the University of the Philippines (UP) Law Center.
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ANNEX A. Process Flow on Initial Application of Certificate of Inclusion (20 Working Days)
INITIAL APPLICATION OF CERTIFICATE OF INCLUSION
Blood Service Facility (BSF) DOH - Center for Health Development (CHD) Lead Blood Service Facility (LBSF) NVBSP
- Information Management Unit j
stat
f
'
Verity NBBNetS appropriate use of
fi
|
Receipt and checking
" n
'
«
:
: donation 1D
for
i
NO
Tequired documen \
Submission of '
complete?
V
Application |
Documents Notify applicant BSF i
|
i
where to process its '
' Thscription of NBENetS / proper
application V
of sticker verifiable?
Referral to NVBSP i
YES documents :
verification
i
i
i
‘
i
i
i
i
i Forward NBBNetS
i
Is compliance Notify BSF to submit \
subscription status and
received within 20 A compliance within 20 V
Application Documents for
working days? working days deliberation and
‘
appropriate action
)
i
i
i
i
i
i
\
'
|
Acceptance of i
Verify type of
Recommendation Letter and |
application
Application Documents i
i
l i
Submit i
i
recommendation i
Document to i
DOH-CHD
i
Issuance of COI i
|
i
'
i
i
i
hh
ANNEX B. Process Flow on Upgrading of BSF Category (20 Working Days)
i
UPGRADING OF BSF CATEGORY FOR CERTIFICATE OF INCLUSION
[
DOH - Center for Health Development (CHD) DOH National Voluntary Blood Services Program Central Office
NO
YES
NOTE: All BSF with application for upgrading shall follow the steps in the initial application first.
SY
—s
ANNEX C. Process Flow on Renewal of Certificate of Inclusion
|
[
RENEWAL OF CERTIFICATE OF INCLUSION ]
|
]
Blood Service Facility (BSF) Lead Blood Service Facility (LBSF) | NVBSP- Information Management Unit DOH - Center for Health Development (CHD)
r
V
‘
Start : ‘
'
Verify NBBNetS
‘
'
'
:
appropriate use of ‘
; donation ID
or
:
subscription based on
Submission of Receipt and checking of : available documents! ’
: Application Documents
:
NO i
}
GUhscription of NBENetS f proper use ‘
‘
‘
: sticker verifiable? i
i
'
Referral to NVBSP | i
'
Assessment of IMU for NBBNetS | \
'
applicati Documents '
torments |
Final evaluation by RBPC
verification +
YES : }
i
i
‘
: Forward NBENetS i
Notify BSF to submit ' subscription status and i
in p Aa
liance received
complian within 20 NO i
working days?
working days deliberation and i
|
appropriate action i
YES i
‘
'
\
‘ A
v.
'
}
'
Submit recommendation and '
Application Document to Issuance of COI
DOH-CHD
'
'
'
'
i
‘
i
'
Co
i
Qo)
of
ANNEX D
Checklist on Initial Application of COI/ Upgrading of BSF Category for COI
Initial application with no request for upgrading J] Initial application with request for upgrading
Requirements
1 Check (/) if
complied
and
1. Letter of Intent addressed to the CHD Director, Attention: the RBPC
BC.
2. *Upon Verification of Category by the LBSF, submission of:
» Memorandum of Agreement with Lead BSF* OR
=
Memorandum of Agreement with Dialysis Clinic **
Recent copy of DOH-License To Operate (for initial application with request for upgrading)
BCU
=
P.1. The Memorandum of Agreement shall be region specific. However, the MOA shall have the following
Blood
provisions that the satellite BSF shall comply.*
2.1.1, Commitment to provide resources for Voluntary Blood Donation Activities for
HBB+
Manual
2.1.1.1. Total number of manpower involved in BSF based on category
Standards
a. List of dedicated personnel with designation
for
2.1.1.2. Vehicle Availability
2.1.3. A functional and active HBTC is a prerequisite for the issuance of the COI. HBTC minutes of the meeting with
pictures (for hospital-based only)
2.1.4. Patient billing statement reflecting fees for whole blood, packed red blood cells. platelet concentrate, and/or
fresh frozen plasma (Compliant to AO 2015-0043)
2.1.5. Weekly Blood Inventory Management Report
ANNEX D
Checklist on Initial Application of COY/ Upgrading of BSF Category for COI
2.1.6. Use of the NVBSP prescribed Blood Request Form for Adult and Pediatrics (Hospital-based only) for
appropriate indication for transfusion as stated in the Philippine Clinical Practice Guidelines for the Rational
Use of Blood and Blood Products and Strategies for Implementation
2.1.7. Letter of application for subscription to NBBNetS or proof ofappropriate use of Donation ID sticker
2.2. Memorandum of Agreement (MOA) with Dialysis Clinic (free-standing or hospital-based dialysis center not
owned by the hospital) as end user**
2.2.1. Patient billing statement reflecting fees for whole blood, packed red blood cells, platelet concentrate,
and/or fresh frozen plasma (Compliant to AO 2015-0045)
2.2.2. NVBSP prescribed Blood Request Form for Adult and Pediatrics (Hospital-based only) for appropriate
indication for transfusion as stated in the Philippine Clinical Practice Guidelines for the Rational Use
of Blood and Blood Products and Strategies for Implementation
2.2.3. BSN meeting attendance
2.24. Compatibility testing/ Cross-matching Form
2.2.5. Commitment to support advocacy, voluntary blood donor recruitment and blood donation activities.
Assessment:
Reasons:
Lead Blood Service Facility Supervisor Lead Blood Service Facility Head
for
Current BSF Category:
and
2. Recent DOH-License To Operate
BC.
3. Certificate of Inclusion issued for the current year
4.1. The Memorandum of Agreement shall be region specific. However, the MOA shall have the
following provisions that the satellite BSF shall comply. *
Blood
4.1.1.Commitment
B8Cy
to provide resources for Voluntary Blood Donation Activities for
HBR
Service
Manual
4.1.1.1. Total number of manpower involved in BSF based on category
a. OR/CR of vehicle
4.1.1.3. Allotted budget for blood donation activities
4.1.3.4 functional and active HBTC is a prerequisite for the issuance of the COIL HBTC
minutes of the meeting with pictures (hospital-based only)
4.1.4.Patient billing statement reflecting fees for whole blood, packed red
blood cells, platelet
concentrate, and/or fresh frozen plasma (Compliant to AO 2015-0045)
4.1.6.Use of the NVBSP prescribed Bload Request Form for Adult and Pediatrics
(Hospital-based only) for appropriate indication for transfusion as stated in the
Philippine Clinical Practice Guidelines for the Rational Use of Blood and Blood
for Impl
"
Prodi
ies
St
ANNEX E
Checklist on Renewal of Application of Certificate of Inclusion
4.2. Memorandum of Agreement (MOA) with Dialysis Clinic (free-standing or hospital-based
dialysis center not owned by the hospital) as end user**
4.2. L Patient billing statement reflecting fees for whole blood, packed red blood cells, platelet
concentrate, and/or fresh frozen plasma (Compliant to AO 2015-0045)
4.2.2.NVBSP prescribed Blood Request Form for Adult and Pediatrics (Hospital-based only) for
appropriate indication for transfusion as stated in the Philippine Clinical Practice
Guidelines for the Rational Use of Blood and Blood Products and Strategies for
Implementation
4.2.5.Commitment 10 support advocacy. voluntary blood donor recruitment and blood donation
activities.
7. Quarterly BM Report (Consolidated report from previous year and 1-2 quarter of the current year)
8.1. Certificate of HIV proficiency of the blood bank staff issued by RITM TTI-NRL
8.2. Update file on referred tested-reactive blood units for confirmation at RITM TTI NRL
NOTE:
For 8SBCU, both BS and BCU columns con be used to chock their tequiroments whichever is spplicable to the requirement stated.
Hosgilad Blood Bank with Additional Functions (HBB+) — ceflined as a hospital-based Hood service lacililies thal are Levels 2 and 3 Private and Government Hospitals thal may
continue blood collection from volunteer load dondrs; blood testing using the NVBSP recommended melhodokires and componant processing based an AO 2008-0006-4 and AC
201240012
ANNEX E
Checklist on Renewal of Application of Certificate of Inclusion
Assessment:
[JrRecommended for issuance of Certificate of Inclusion.
Reasons:
Lead Blood Service Facility Supervisor Lead Blood Service Facility Head
Date:
the
Dear Director Dela Cruz:
Greetings!
Blood
Bank)
e.g.
(Bleed
In compliance with DOH NVBSP Department Memorandum No. 2016-0448 for the issuance
of a Certificate of Inclusion of Blood Service Facilities (BSFs), the (Name of Blood Service
Address
Facility) located has complied all
Category
at with
Service Facility)
(Complete
The (Name of the Lead Blood Service Facility) hereby recommends issuance of a
Certificate of Inclusion as for the
Service
Hospital
above mentioned BSF with the validity period from (January 1, 2021 to December 31,
2021).
Thank you.
TE
ANNEX G. Sample Template of COI
CONE NGXONGXONEX(NXNX
XX
oN)
Republic of the Philippines
X Department of Health
aN CALABARZON Center for Health Development
X
ONG
Certificate of Inclusion in the
X
(ONG
Regional Blood Services Network,
“¢
An active member ofthe National Voluntary Blood Services Program, Regional Blood Services Network,
pursuant to RA 7718, otheswise known as the National Blood Services Act of 1994, and its
/
Implementing Rules and Regulations, A.0.n0.95 s. 2005.