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May 12, 1998


ADMINISTRATIVE ORDER ·.
No. If~ A s. 1998

SUBJE CT : ftmend ment toSec tions 26 to 32 of Admin istrativ e


· · Ofd.er_ No. 9 · s: · 1995 to 'be known as Requir ement s
fJ.nd Proce dures tor a Licens e to Opera te a Blood ·
Bank I ,Blood (;enter in the Philipp ines

Provisions of ChapterVIIJ Section 26 to 32 of the. Administrative Order No, 9 series


of
1995 dated April 28; 1995: Rulesa nd Regulations Implementing _Republic Act 7719,
otherwise known as the ,"National Blood Services Aqt of 1994" dated August 1994,
are
hereby amended'.tdo.i:l knoWii as the "Requirements and Procedures for a License
to
Operate a Bloo(j BaqK/B iood Center (BB/BC) in the Philippines". · ·

Sectio n 1 •.TITLE :

f · This Admif1istrative. Order_·. shall be known as 'Requi remen ts and


IJ
ProcedurE!s for a License to Operate a Blood Bank I Blood Center (BB I
BC) in! he! Philippines". ·
Sectio n 2. ~E~ud;/;::_·:_:·-
,TORY AUTHO RITY
' __ ;_· :_:_-_::_:.-.__
__ ·.. __.·- ' ' . '.·" __ .;-·: . _· ____ .·
.J'hi~}A'ctlpiiiistrative Orqer is i~sued pursuant to Republic Act 7719
(t';la,tio11al Blood Service~ Acf of1994 ) and its Implementing Rules and
RE!fJtJiatiqns (A,O. #9. s. 1995}consistent with E.O. 119 (Reorganization
ACt. of the. Ministry of HealttJ),cThe licensing and regulatory functions of
thei DE!parrrient of Health fOrBidod Service Facilities shall be. exercised
. through. the Bureau of Research and Laboratories (BRL) under the Office
fol' Health'Facilities, Standards and Regulation (OHFSR). As such, it is
·.-.·. hereby authorized to issue orders . alid circulars . providing for the
implemeht;:~tion details. and . speCific technic al and admini strative
· reqtjirementsrelated to licensing andregulation.
·;- -.- . ' ~;:.; ' .

Sectio n 3 . Pl.Jl:i-R0$E

Thi~(AC!ministrative Order is being issued to enforce RA 7719 to protect


al)d>pr~mote the health of the people by preventing the operation and
maintenance of sub-standard Blood Bank I Blood Center in the country.
·.

.<:-·.
Section 4 SCOPE :' ; ''>
·.-;_.;
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. -··

These requirements and ·.·.. · • shall· apply to all establishments,


owned. arid operated by the go~erpment and non-government agencies,
and private individuals en·gaged in blood banking . and transfusion
services within t['le ge()graphi?alboundaries of the Philippines.

Section 5 SERVICE CAPABIL


- .;.. -.
.. -'..
ITIES _,:
OF BLOOD _·.
BANK I BLOOD CENTER

Category A· . · (Non Jlospital-Bas~d)


1. Recruitment andreten tionofvolu ntary blood donors
2. Health education' and cou~Jselling
3. Donor screening and selection
4. Blood collection . ,: ·· ·. .. .·. .
5. Blood testing for blood transmis.sible disea.ses
6. Provision ofwhole.b lood an.d packed red blood cells
7. Storage of whole blood and papked red blood cells
8. Issuance, transport and distribution of whole blood and packed red
blood cells .· · · · · · ·

Category A (Hospital-Based) .. · ·

1. All of the above (Category A -Non Hospital-Based)


2. Compatibility Testing ·

Category B (Non"·- Hospital-


. ,,- .. Based)
.. . ,·, - _.

1. Recruitment and'fetentibn of.voluntary blood donors


2. Health education and'couriselling .
3. Donor screening· and sel.eption ··· .
4. Blood collection . · · · ·. · '' • ·. · ·. ·
5. Blood testing forblood ir~nsmf$si ble diseases .
6. Provision of whole ,blood, packecLred blood cells and other blood
components. ,.. , . · . · . . ·.. · . . · · .
7. Storage ofwhole. blooci and blood .products
8. Issuance, transport i:md distribution of whole blood and blood products

category B •(Hd~~il~FBase'dj' ·
1. All ofth~ aboJe{Ca tegoryB -Non Hospital-Based)
2. Compatibility testing . ··. ·· ·... ·. . . . : ...
3. Preliminary investigatiopqfJrari~fusion reactions
4. Resolution of irii::or:Jipatible{,pr6ssmatphes ·

(
2
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""''nnmlic:h,,rl and notarized Petition I . i


AP!)IiC~ttiorl.FCim (BRL- BSF (BBIBC) Form No. 1), '

b.:' . Blood Se~icesNetwork Documents (Administrative


Order #9 s .. 95, Chapter 8, Sec. 28, Item 10):
b.1. · Cerm.icate.of Inclusion in the.Official Blood
Services Network of the National Voluntary
.Blood Services Program Unit (NVBSP), .
b.2 Lists otBiood Collection Units and Blood
Stations within their network to include names
oftheir respective personnel,

c. Certificate of Registration . . .
c.1. · .If Corporation /Foundation Proprietorship I
()wn!;)rship~Certified True Copy of (SEC)
. , $ecurities and Exchange Commission ·
.Begisiration · ·
c.2. •. If Single Proprietorship I Ownership
Certified True Copy of (DTI) Domestic Trade ·
. andJnductry Registration
. - . .

d. . Photocopies of PAC Certificates of Personnel of the


I
' . Blood Service· Facilities, ·
d.1 · Additional requiremE:Jntfor the Head of the
• Blood Bank I Blood Center
'~ -,
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. . JfPatholbgist, Specialty Board Certificate


· · · · issued by the Philippine Board of
I ..·.· . · .Pathologist ; · .
·.'If. Hematologist, Specialty Board Certificate
· issued by the Philippine Board of
'. Aerna:tology and Blood Transfusion ,

·. e. L 0cafi()r:imapco{the Blood Bank I Blood Center,

f. Flobr cji~'grk'tn ~f the Blood Bank I Blood Center and


. its.pr~mises, · ·
..-'-. -.·· . .._'.

g. . List oLEquipment- to include .serial number, brand,


. ., c(ate of purchase, humber of units and operational
· ··.. status·
. '· '
· '
·

. h. · cis\'btglas~W~res and supplies, and

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Requirements

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.· . . urn number of staff with their corresponding
. · ·.qualification for each . . category of Blood Banks I Blood
· ····.Centers shall pe Cl~ follows:

. · A., 'HEAD (tor b,othGategory A & B Hospital-Based &


,·· · · · ···.·. Non-Hospital-Based):
·:·-.: ..
The overall supervision and management shall. be. under a
regist13red Physician duly licenseq by the Professional
· >Regulation Cd.mmission Certified in Clinical Pathology by
the Philippin~ Board of Pathology or Blood Banking by the
Philippine Board. of. Hematology and Blood Transfusion.
:---: . -
·

B,.TECHNJCAL STAFF·

·Medical Technologists

The Blood Bank I Blood Center shall have Medical


Technologists whp shall work on a shifting basis to cover a
· ·' 24,c hour service. Medical Technologists must be duly
. registered by the PAC with valid. professional license (PAC
ID Card)'and with alleast one (1) year on the job training or
. experience
. .
in blood
.. banking
.. . . services
.. .. - -

F~r Bl~6d ~ank Category A - aUeast Four (4) RMTs


. based on:... . .

bne(.1}'RrviT irv~yeryshift (Morning, Afternoon and Night).


and One.(1) RMTonoff-duty ..
i
-... ·.·:. -;- .
For. Blood Bank Category B - at least Five (5) RMTs
based ,on : '· · ·

· T\',10 {2)' RMT in mOrning shift, one (1) RMT in afternoon and
night shift, and one (1) RMT on off-duty.

D~norRecrtdtmentOffiC:er (For both Category A & B


,. Blood Bank/ center), ·

· The BloodBankiBiood Center shall also have at least one


(1) desigpated:bp[ior Recruitment Officer who is either a
Registe(edM[)JRMT
. ~--
I AN ..
. -. . . ' - - ' '

·s
housed in a well-lighted and
well-v·enfilated area with an adequate supply of water.

The ~pace shall b€1. sufficient to accomodate the various


activities ofth~':blqod bank I center with provisions for
accessible anc.l Cl~arlydemarcated fire exits .

. The physical arr1'\ng€)ment should allow for the smooth and


orderly flo...y of activities and movement of peopl~ and
supplies. ·, ·

ThE:) technica l or
working area shall be exclusively for the
use ofthe blood bank/center and its other related activities.

7 .1.2 A Equjprnents, Reagen ts, Glassw are &


.
Supplie

', ·-·
'•
s

The blood bank I ,center shall have th.e equipment,


reag~nts, gl~~sware, blood bags, and other supplies
needed to 'properly undertake the required services. ·

Table. 1, '2 & 3 pre~ents the minimum requirements


respectiVely. for equipm ent I instrume nts, .reagents,
glass..yare and s!lpplies necessa ry to undertake the
'required services.

7. 2 Requirerm~nts for 'Renewal of License


The license Of<rBiood E!a.llk/ Center to operate may be renewed
only. if it shall have co!15plied with all of the requirements for a new
license,witht~e following additions or modifications:

7 .2.1 .··. Docum ents

a. . Ouly accomplished}l.pplication Form for Renewal of


. License(BRL-BSF(BB/BC) Form No.2),

b. Chahge siHthe li~t authorized Blood Collection Units and


bf
BloodStalion'(dele,tions or additions only) within their
..••.· i:i\'l!work}':> . .· ·· .

c. Names; qualifications and proofs of qualification of new staff


· and any staff dE:)veiopn1ent (e.g. additional trainings
. orqualificationsfor existing staff, resignations),

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applic~ble, •· .
.-
facilities and equipment and
. ' ' '- .

,· ...f. •·••·•· Newly aC:quir~dequipment and facilities,


· Annual Aqbbrnplishment Report on Blood Services of the
· pre\iious year, ·
. ,:
. . ·--·
. - ..,- . . . . . . .
. h.. ..·Names alld ~ddresses ·of blood
donors with rare blood ·
· types!

i. DocumenJed changes in Blood l3anking Standard


· . Ope1rating Procedures,

j. Passed Rating in the §:xternal Quality Assessment or


· ,Proftciency Testing of .the previous year,

k. ·. · ·Documented accomplishment of at least 70% ofthe staff


development plan targets for the previous year.
Section 8 LICENSE• FEES. AND CliARGES .

8.1 The• lf~~?l1s£fees . and tharges shall be uniform for both


goyElrnrn~nt }!nd ,·on-government blood banks I centers and shall
...· be adjustecj .only, by. the BRL through appropriate official issuances
· • as the need arises. . · · · ·
8.2 All fees /th~rges sh'alf.qe payable to the Bureau of Research &
Laboratories. · · ·. · · · ···

. s. 3 LicensE! Fee , · ·
a. A non~ref~ndabl~ license fee of six hundred pesos (P600.0 0)
· shaltb.e charged for every accepted application for a new license
. to operate
'-- . a.
---·
'',
bloog bank
.
f blqqd center.. ' ., ' ~

b. A non-retGrictableifee off~ur
hundred .pesos (P400.0 0) shall be .
· charged for every accept~d ?PPiication forrenew al of license.
·:.-.:

c; . 1'1:te licehse tee shall, co.ver tne cost .of inspection and printing of
license • certific<J,tes. and other required ·forms and documer:tts.
Subsequent. or SE!para.te. issuances shall cover other allowable
. fees ar:td charges (e.g: proficiency testing fee, blood service fee,
'etc,), , . · · ·

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Section
9. TERMS
. AND
- -
tONDITIONS
---
', -- -:---.' OF-. LICENSING
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A licensci is granted on the basis of compliance to certain requirements


as est<tblished dLiripg the inspection and defined in the issuance of the
license. · · < •· ·. ·· · · ·

The following are)het~rmsand copditions of the License:


9.1 . Alicens!3 tdo;erate a Blood Bank/Center shall be signed by the
Underf;ecretary ofHe~lth for H!3alth .Facilities, Standards and
·· Regulation: II. shaH be. issued t.o.·persons,a:gencies, corporations
ryho' h?ve successfully. somplied with all of the standards and
req~Jt;emehts. ·· ·· · · · · ·

9. 2 Th~ liCense is valid•fora~maximum of one (1) year from the date.of


issue,.Jhe exact •date. of expiration of the license shall be printed
;cinthe licensE!.. · ·

··· 9:3 '~II'he didmse; as well a; tt1e rigl;ts under the license, is non-
.. transferable; directly
. . ._,._ .. ·,___ - 0r indirectly. ·
__
· ,· '.

9 A .. The license.of the Blood ~ank (Blood Center shall be displayed in


. a corispiCupus place withiri the Blood Bank I Blood Center. A
notice· shall be. posted Jnforrnirig the public that complaints. about.
· the ser\tices,rnay:He.iac!,~re§se~lftJ the Chief of Hopital (if Hospital-
Based) or; to
lbe Head of:fbe Blood Bank /Blood Center (if Non-
.· · Hof;pit?l"Based)'or to the Direptor ofthe Bureau of Research &
Laboratories; · · ·• ·· ·
; ___ ,- . ··\-:<;_·. _ ---
.. ,-··

9. 5 Blo~d CblleCfi&ri tJnit(s) ancl Bldod Station(s) linked within the


Blood ·f:lank /Center Blood Services Network will function under
. the license
_- -.~: ---:---- _:::-._. ottheHr
--- ·; :·- parent
.·. . -_-
Eilocid
--- _- Bank
·- I Blood Center.

8
The. following are procedure~ t6 be· followed when applyi~g. for a license:
. a: A duly acpomplish~d and
notarized Petition/ Application Form
· · (BF!L~BSF (BB/BG)Fon;ri No. 1), or J\pplication for Renewal of .
License (BRL"'B SFi (BB/BC). Forrri No;' 2) together with all tiie .
. requirecl~pppor:ting documents shall be' 1addressed. and submitted
. to the Bu~eau of·
Research ;:tpd Laboratories '(BRL)- Division of
Laboratory:Regulatiori ahd Deve[qpment(DLRD). . . ·
b. Ap~licalionsJo~ ~e~ license maybe submitted anytime.
c. Applicationsfor renewal of license should be submitted within 2
rnoniiis ~rior to the expiration ofthe current license. ·
1 0. 2 D~cprt1~11f Scree11iQg 'and Approval
a. DL~·~ ~crel:lns andjva luate;ti ie documents for completeness
and authent icity ... lf 'complete, application is accepted .and·
I .
approyed: A ciiarge, slip is issued and the applican t pays the
correspon~irig license fee at' the BRL Cashier Section.

b. If l;!obu~ent~ are incornplete, a fetter is sent to the applicant


informit:ig'f:lini:/ heroHte ms for. compliance and with a directive to
cor'r)piete said 'items for compli<J,nce within such period of time as
ITla{bew
'- -:- -'
amihted
·--. •.·under
' .'
the·,.cfrcu
:.
'-
mstances.

a, ·Ass~ssment of a Blood 13,ank/Biood Center for new license to ·


op~rat(,) .and renewal ofliqens e shall involve;an actual inspection
:of':th~,facility al)d>evalualiop ()f documents by authorized BRL-
.. · E!lo,!?'dBank lnsp(,)ct6rsat least once a year or as rriay be ordered
:f(y th~ Dir(,)ctor: · · ' ·· · · ·
;b~t,\'; Qd\·~ {nspectors who·. have ,satisfac torily completed the .BRL
·•·.· i;Jitai!liqg.Qo.l!fse for Blopd' !;!an~ Inspectors are qualified to inspect.
Bld,q~.,~ank/Centers and other blood service facilities.

c. · ln~~~c!iC>Ilshaii, be dori~'Only if applicants have complied all the


>; ~~~i§,.requirernents, ·
e. . l~spection of licensed blood bank/center shall be done
·unannounced while its .activities are going on.

f. Ea~hlicen~ee sh~ll make available all· records and documents as


· may. pe r§lql.lire.d by th'!l authQrized BRL Blood Bank Inspectors
Up<>ri·presentation of a Valid inspection mission order signed by
the Secr~tary or its authorized representative.

g. · Appl[cants for Jic:ense to Operate who,. upon inspection, did not


. meet all.of the prescribed standards shall receive a letter from the
..··· BRL stating the.requirernentswhJ.ch the Blood Bank I Center failed
. t? meet. Jbese Blood Bank I Centers shall be revisited at least
Qnce after release of.the order for confirmation of compliance with
the order: . . .. ·.

10.3.~ .·· Documents· Required on Inspection

a. ·.. Copies ofManuaJpf forBlood Banks/Centers, Sta~dards


Bloo<j C<>llection ..Units, Blood Stations in the Philippines

b. • Donor Forrns:
: . - -...-: . ' ·.:.. -:.".>.- ' -- ;, ' :_ _:

f. [)on or History arid physical Exarnination


2: lJonor Medicaroec:laratibn Form

c... $taff D.evelbpment Plan for at least one (1) year

d. Book. C>t'Acdounts or Cash Books or official Receipts


showing colleciiori of allowable service fee for each blood
.·.·.unit dispensed.. •.
:, :: ~- -_,-; :· , _ _.- ·' c
· -· • - - - '_·' :- • '

e. ;.fv1inut~s ()(Meetings of the Hospital Blood Transfusion


· Committee ·

f. \ ~ariua.'s /Logboo~s on: .


· 1. · '8ualitVSy~l~m M~nual (Administrative SOPs
•· · . >,; .. Manual) . ·
'! ..-.

• :- <
,:....;.:.;..~:;:;;<'.~.:-".:-~,.-.:.<~;;,.;,·:;; •..;,c.,::;;·.:.~:; ..••. ~.-:-· ...•
.. r prov1s1on of Health
Edu · · ion, Pre & Post-Donation
Counselling Services for blood donors
(A0#9 s. 1995 , ChapterVIII, Sec. 28,
.. ltem9) ·
b. ·· Guidelines for referrals of blood donors
for fljrther medical evaluation (AO #9 s. .
. 1995 , Chapter VIII,. Sec. 28, Item 9) ·
c. Blood Distribution and Transport
Guidelines (AO #9s. 1995 , Chapter VIII,
Sec. 28, Item 7)

1.2< · BB /BC Organization and Personnel Job


· · Delineati<m,lev(31 of Responsibility, Task
·. Delegation
. . .
and
. .
Coordination
. '

1.3 ·· Personnel Developmentand Competency


: Evaluation .
. . ~. Technical Procedures Manual (Technical SOPs)
,.~: ... Bios~fety andWasteManagement Manual
' .. . . . .

·. · ;4, ••· Equipm~ntMaintenance


. . -:.-. . . ,-_ .
& Repair Logbook I
-- •' ;,
Record
•''/

5:. · ()LiaiJiy. MahagernehtRecords

···Fle~~rds.of BkJod.·Donations
· 6:1 · Dorior Session Record
6.2. l:llciodCollection Record

· Laboratolo/ Pro2el3sing ofDonor Blood


7:1' ·Records·ofTests on Donor Blood Sample
· ].2 Labelling • ·
•·• '7;3 · R136ordsc)f Component PrE)paration
8. R13cords of B,lood Transfusion . .
'8.1:·.·.· Recordsqf BloodTransfusion Requests
•·· s.2 .· 'f'le¢Qrds,c)fCorripatibifityTests
. 8.3, : f1ec 0 rds•c)Ussue for Trarist4sion
· .8.4 Records ofTransfusiori Complications

; _:.: .. ,.

.. ··'·ll : ..
He<concts <::>t E1mel'ge11cy
.· Transport Re<~onjs Issue of Blood
Records of Blood .and Co
mponents Received
· .. from Other Facilities
·.·to. Records of Errors and Ac
cidents
·· ·•. 11. . Summary Re
cords
11 .1 Annual Blood Co
:-.- ··.
llection and Utilization
1 0. 3. 2 ,E:Hernal Qual
ity ~ssessment
. ThE;! BR L sball condllc
ta
ProfiCiency Testing to all yearly External Quality Assessment l
I . ba rik r center who go licerised blood bank I center. A blood
t a sa tis fa ct or y rating
. qu al ity Assurance Citat will
ion Certificate. Superviso be given a
conducted as· necessar ry visits will be
y fo blood bar1ks J cente
th~·External Quality As rs who tailed in
/ ·.=· '. sessment.·.· · ·
Se ct io n 11 ISSUAN
CE <lF LI CE NS E
lmmediatelyaft~r appr()val an
iss ue d dir~c'tly to the d evaluation, license
is
(personally of by mail). He ad of the Blood Bank or his prepared and
· representative
·
Section 12 VALIDITY
~~:LIC~NSE
I Each license. shalL expir
e on its ar1ili\fersar{ date
of the year stated.
. Section 13 TRANSI
TION .PERIOD FOF(.C
ONFIRMATION OF LI
CENSES
M ay 28, 199,8 to Juiy·
confirmation of complia 31;:.19QS sh al l be the transition period fo
nc
Blood Banks /,Blood Ce e to ttie..nei,V licensure requirements of existingr
nters fOIJO:wing th e new
BRLcOLRD .·shall. issue BSF categorization. Th
. ce ntiticates to ex ist e
based on the NVBSP '-B ing
iq()d Se rv ic es Ne tw or k blood service facilities
operation until confirm
O~ffi~. ation of lic"ln.ses I ce Guidelines to continue
. rtificates • of authority
.. to
Section 14 PUBLICAT
ION O F THE LIST OF
CE NT ER S LICENSED BLOOD BA
NKS/
An annual updated .lis
published at le as to nc e .()f libens53d blood banks/ centers shall be
t
ay. ea rjn a newspaper
- ~
of general circulation.
.
15 .1 ln ad di tio t'l 'td
A
Documented blood co .o ,N o. 9 s. 19 95 ,C ha pt er x, Sec. 47
llection fron:r paid. do , Item 1,
th e su pe ry is ip g. ot 'a nors; blood collectio
physici?n; non"perfo n without
. testing; and dispos rmance of the require
al () fb lo od unjt~,to d blood
· cause·- for tbe. cancel unauthorized pe rs on
' . , ... . --· -_ lat[on, revocation or su s sh all be a
. -,,• spension of the licen
·S ec tio n 16 ·A PP EA
- '
- - se. .
LS AND RI:PbRTS
ON VHJLATIONS
· ReportS\b~ ~io]~tio
n.ofHA7719 and these Rules
be addre~~~(:!Jo. ~he·
$e and R~gulations shal
Re.search an d .Labor cretary. of f-l~alth and the Di re ct or of the l
atgries. · Bu re au of
$ecr~tary tMDir~ctor
·
The or
an d tne Natiqrial Bu 6f B R L may request
re au o f Investigation for Police Assistance
l? ol ic ef on th e effective an d/ or . the Philippine
inforcement of RA 77 Natio
Rules ari(j Regqlatio
ns .. 19 and these. Implem nal
_., -: ·::· ., . ::
··· . . enting
~,;
. Section 17 REPE
ALiNG .C LAuse.·
These re~uirements
an
C ha pt er VI Ifo fA dm in d prp(::edures shall supersede Sections
is tra tiv e O rd er No. 26-32,
Orders and<Circulars 9 s, 1995, an dr el at
issuances)nt::onsiste
6f th eD ~p aqrnentThe.. provision ed Bu reau
nt wi th 'this administrative orde s of an y of these
o r modifiedaccordin r are he re by repealed
gly. . .. .. .
\ Section 18 iFF~CTIVI'TY CLAlJSE
. These requirement~·afld
· Transition Period of. . pr oc e; uf es shall
§{.)days.fr om date of, take effect May 28, 1998. A
the trans.ition period . effe
for" confirmation of co ctivity of this order shall be
re qu ir em ent~ a'nd.p(oced mpliance to these lic
.
.. ure. · ensing

- ·. . .

. cAaMEN~li\~oiCII, M~.
.· ....•·· ....· · · ·. ·. :Secr~taiyio MPH, CESO
. . . ... f f-lealth .
·~-"
.

. ... ·
;13 .·.·....

. :··,·_.-,-.
. T ab le 1 - BB I B C
M IN I M U M
BANK I CENTER
CATEGORY A
BLOOD BANK I
~!H!ospital - Bas CENTER CATEGORY B
ed
I. N on -H os pi .t al -
B an k R ef ri ge ra to r B as ed
co nt ro ll ed at 1~6 C: Blood Bank Refrige
w it h te m pe ra tu re rator
recorder, al ar m sy
st em ,& · au to m at ic controlled at 1-6 C
_"f _.·, _- .
vo lt ag e. w it h- te m pe ra tu re
}\ gg lu ti na ti on vi ew : . ·recorder, al ar m sy
er for A B O /R H gr st em , & ·a ut om at ic
ou pi ng . re gu la to r vo lt ag e
(t ub e m et ho d) A gg lu ti na ti on vi ew ·
Blood do na ti on co er for ABO /R H gr
uc h or be d (t ub em et ho d) ou pi ng
:1lrgical in st ru m en · · ·
ts : forceps, scissors Blood do na ti on co
H em og lo bi n pete · uc h or be d
~ination . • . Surgical in st ru m
en ts : forceps, scisso
l. bJCyanmethell}og ·F or H em og lo bi n rs
lobll1. M et ho d: I)eterminatio~
ip ho to m et er /H ei · ·· .
n o cu e · 1. by Cyar\J:rlethem
b y C op pe r S ul fa te ·. S pe ct ro ph ot om et oglobfu M et ho d: .
M et ho d er ·/ I-lem&cue i ·
· 2. 9Y C op pe r Sulf
ate_Method ···
l'y cn om et er .·.
L ab or at or y O ve n • · · . . · ·.·.·••· .
(fqr In st ru m en t •D .
ry in g Pu rp os es )
Sphygmomanon:\e
ter
St et ho sc op e
T he rm om et er s·
- · · Room Thermom
eter- ·
··..: "''•• L ab or at or y T he rm
om et er
Clinical T he rm om
Weighing Scales et er
for Blood D on or s
~J:!;ilergency G en er for Blood U ni ts
at or po w er un it (a Autoclave.
~l\1icroplate Ti:ay t least 20 KVA)
V ie w er for .PA M et ho E m er ge nc y G en er
_Clinical ce nt ri fu ge d at or po w er un it (a
M ic ro pl at e T ra y V t least 20 KVA)
'\C en tr if ug e for Q iewer for PA M et ho
ua nt it at iv e Buff)i Clinical centrifuge d
M al ar ia de te ct io n C oa t M et ho d for
C en tr if ug e for Q ua
nt it at iv e B uf fJ C oa
'-'V ·< Malaria detection· t M et ho d fo r
~""··
Refrigerated C :e nt · ·
Pl~C::rn~ -c ri fu ge w / AVR~- .•
Table 1 - BB I BC M IN I M UM
BANK I CENTER CATEGO I INSTRUMENTS
RY A BLOOD BANK I CENTER
':;~';,Hal" Based B
. I. No n- Ho sp ita l -B as ed
~Equipment set w I AVR
. EIA Eq ui pm en t se t w I AV
R
EI Ar ea de r w ith pr in ter
including he ati ng block EI Aw as he r
diluter w I Go-no-Go tester Incubator including he ati ng
se t bl oc k
ioscope, Binocular wi th Oi Microdiluter w I Go-no-Go
l Im me rsi on Objective tester set
with UV Paralens ad ap ter Microscope, Binocular, wi
for Malaria th ·
,siteDetection UV Para!ens ad ap te fw ith
Oi l hn me rsi on
Objective forMaJaria P~f~si
. Pipettor, 10~100ul te Detection
PlasmaEi<tractor ·
Plat~l~t Rotator , · ·.·
.·Reagent Re,frigeratot w l A
)watch or T1mer Ro tat pr fo r RPR/Vl)RL VR &. th en no me ter
·. . .
fe rb ath w/ th er m om ete r (l StopWatch or11irler ·: ·
O~lOOC)
w
.• Waterbath I thermomete
r (10-lQOC)

II. Ho sp ita l ~ Based ·


above plus th e following
:
C~ntrifuge All those stated above plus
the following:·
~rJ?~.th controlled at 37C Serologic Centrifuge
(for crossmatching)
· Dr yb at h Waterbath controlled at 37
C (for crossmatching)
Water or Dr y ba th .
Table 2- BB IBC · MI NI MU M REQUIREMENTS
FOR REAGENTS

BLOOD BANK I CENTER CATE


GORY A BLOOD BANK I CENTER CATE
GORY B
!on -H osp ita l-B ase d
I. No n-H osp ita l- Based
[~moglobin De ter mi nat ion
-b y CuSo4 Me tho d For He mo glo bin De ter mi nat ion
·
'.CuSo4 Solution, Sp. Gr. of 1.053 -b y CuSo4 Me tho d
Distilled Water Ct.iSo4 Solution, Sp. Gr. of 1.053
~by Cy anm eth em og lob Distilled Water
in Me tho d
Drabk~ Reagent -b y Cy anm eth em og lob in Me tho
· ·orabkins Reagent d
[eri:loglobin Standard · · ·
Hemoglobin Standard

-FniW~rcl Ty pin g (sl ide /tu be 'Fo r ABO 2ro up ing "' .> . , ·. . .. . . . . •· . .
me tho d) · -Fpryvard~';f)>ping (sl ide /tu be
·.. 4u ti7 AT yp ing ser a :lllethod) . ·.
ser a ·· ·
-Reverse Typi~g (tu be lll.ethod)c Anti-B Typing ser a . ..
· · ·. .
. . ' . "R eye rse Ty pin g (tu be
method).
·· Kn ow nA cel ls •
· · I<rtowri Bcells · ·

. . Fo r Rh.Typing·(tube me tho d)'


with-:appropriate cbnfi"Ol' · ·· ···· ·
· Anti-D wi th appropriate contro
l
Fo r Infectious Disease Te stin g ·
. . . .
zt~J.tl.fef,. of. the. foil owing)
y-......... ,_,_ & Thin Smear A. Ma lar ia (ei the r of the following
)
"Thick& Thin Smear
Giemsa -Wright's Stain
Quantitative Buffy Coat Method . Buffer water
· -Quantitative Buffy Coat Method
QBC Reagent kit

'·::~1-':·.<.;~f:> .._·_._.. ,
,:~;}~,,_.,,... ~..
.,,~ ...... ,...--~~--
v•-..•-••"'~~·'"
' '•"•-"'--•
·•--~.,..---.,
w-'-·~···--·
·~·----- <v ;0 /'

T ab le 2 - BB IB
C . M IN I M
U M R E Q U IR
LUUU BA
NK I CENTER EMENTS FO
CATEGORY R REAGENT
A S
BLOOD BAN
;t:reening T es t K I CENTER C
for S y p h il is ATEGORY B
.
B. S c re e n in g T
or es t fo r S y p h il
is
.· VDRL Test K
it or
$ c re e n in g T es
t fo r H IV -A b
.· . RPR C a rd T
est Kit
/
C. S c re e n in g
Test fo r H IV -A
or b.
or H IV 1 & 2 PA
T
·. HIV 1 & 2 EIA Kest Kit o r
it or
..· D~ S c re e n in
g Test fo rH B s.
Ag/
EIA Testi<it
··...
E. Scr~e~ing T
or e st fo r H C y '- A b
E IA T e st K it
.. PATestKif·•····.·· or
I t H o sp it a l- B
a se d
A ll th o se st a te
da b o v e p i tiS .the
fo ll o w in g :
Known A Cells
Known BCells
F o r C o m p a ti b
il it y T e st in g
·. -C ro ss m a tc h
l.
l
. in g .
''
22o/oBovineSerun
1A
Anti-Human Glo Jburnin
bulin Reagent
Known A Cells
Known B Cells .
_j
22%BovineSerum
Anti-Human Glo
Albumin .
bulin ~eag ent _
,:~;}~,,_.,,... ~..
.,,~ ...... ,...--~~--
v•-..•-••"'~~·'"
' '•"•-"'--•
·•--~.,..---.,
w-'-·~···--·
·~·----- <v ;0 /'

T ab le 2 - BB IB
C . M IN I M
U M R E Q U IR
LUUU BA
NK I CENTER EMENTS FO
CATEGORY R REAGENT
A S
BLOOD BAN
;t:reening T es t K I CENTER C
for S y p h il is ATEGORY B
.
B. S c re e n in g T
or es t fo r S y p h il
is
.· VDRL Test K
it or
$ c re e n in g T es
t fo r H IV -A b
.· . RPR C a rd T
est Kit
/
C. S c re e n in g
Test fo r H IV -A
or b.
or H IV 1 & 2 PA
T
·. HIV 1 & 2 EIA Kest Kit o r
it or
..· D~ S c re e n in
g Test fo rH B s.
Ag/
EIA Testi<it
··...
E. Scr~e~ing T
or e st fo r H C y '- A b
E IA T e st K it
.. PATestKif·•····.·· or
I t H o sp it a l- B
a se d
A ll th o se st a te
da b o v e p i tiS .the
fo ll o w in g :
Known A Cells
Known BCells
F o r C o m p a ti b
il it y T e st in g
·. -C ro ss m a tc h
l.
l
. in g .
''
22o/oBovineSerun
1A
Anti-Human Glo Jburnin
bulin Reagent
Known A Cells
Known B Cells .
_j
22%BovineSerum
Anti-Human Glo
Albumin .
bulin ~eag ent _
T ab le 2 - BB./B
C M IN I M U M R
EQUIREMEN TS F O R REAG
r> .n :n B A N K I CENT
ER CATEG ENTS
ORY A
B L O O D BAN
K I CENT ER CATEGOR
Y B
For P re li m in ar
y In v es ti g at io n o f
T ra n sf u si o n
R ea ct io n s
.C o m p at ib il it y
T es ti n g
·1. A B O G ro u
p in g
.· ·. -F o rw ar d T y p
· A n ti -A T y p m g in g (s li d e/ tu b e
se ra m et h o d )
· · ·
AnticB Typing se ·
ra . .·
· -Rev se .Typin ,
·K n o w n A ceer g (t u b e m et h o d . ·..
lls ·· · ) •..•
Known B cells · · .· ···
··:
.·.·... .
... 2. Jlli 'fy'pirlg
(t!J,be itlethod)
·- .. A n tF P with ap ..·,.· . .. .
.
..-. .. . . p t( )p ri at e co n tr
'•,' •, _; -~

. . . .
o, l.
· 3. C io ss m at ch
in g ·
·.KnownA Cells
·
KnownB Cells ..•.
·; .
-. ·· 22"/oBovine Si'!tl.lm
Albi.imin
Anti"Human Globu
lin Reagent
· 4. B ac te ri al C
u it u re (c/o Clinical L
aboratory)
For C o m p le te In
v es ti g at io n o f T
(r ef er to R ef er ra n sf u si o n R ea
en ce L ab ct io n s
1. A n ti b o d v ld en H o ra to ry ) ·
fi ca ti o rt

•·
·------~-· ··. -
- "' ~- ~-~-
·--·-·· .........,,... ____ _ _ . ..:-·•- ~·.

(Information
, Education,
& C a m p a ig
n) Materials:
IEC (Informa
tion, Educati
·P o s te rs on, & Campa
ign) Materials
Leaflets · :
Education.& Brochures
C o u n c e ll in g
iEC Materia
ls
H e a lt h Educ
ation & C o u n
Posters c e ll in g IEC M
aterials . ·
Leaflets
)~.$election Brochures
andS
:b o ri o rD e d a c re e n ir ig
ra ti o n Form
Donor lvl:edit D o n o r. SeleC
al:History & tion andScr
DonorDeCiara ;~erting
.:; :
·PJ:i.ysical Exa .
mination Form ·. Donor'Medi tio'n•Form
s. c~LHJ;tory &
· ·•'•"·Physical
,., . ..
.,- .E·_·
x,·.,'iiminatiori F
orms ·
Hen.toglobiri
Det.?J.miriatio
:ISo?roi>vlAlc . Lancet n: . ·.
ohol, 70% · ·
·. . . . nee . · ·· .· · Tourniqu
dles, disposa et
~ipefte, d is ples · lsopropy1A
posable,plas lcohol,1Q;/o
tic .·. :' · S y ri n g e s w /r ·
ie e a le s ,d is p o
Pipette, dispo s a b le s
~ouping sable, plastic
(S Pipette tips
\.pplical:or Slitidcke sM e th o d ) ..
~orii:i.a1 Saliz1 ABO G ro u p in
i~~---t-·::·\.
e Solution(NS g (Slicie Meth
S, Sterile) Applicator Sti od)
· D is p o s a l cks
Normal Salin
~odium H y eSolution (N
poch SS, Sterile)
:J:3ioha'z.ard Pla lorite Solution P ro p e r Waste
stic Bags D is p o s a l
:~olor-coded Sodium Hypo
Plastic Dispo chlorite Solu
~-~· sable Trash B Biohazard Pla tion
--

~'-:':-·..:-}.;>•:'
ag s stic Bags
Color-coded .
Plastic Dispo .
sable Tra
s~ ·
··- ,, ~·~..;_._.~ . .-:-•.::~~~£/'W&fii

iosafety
Personnel protection Biosafety
Laboratory gow n Personnel protection
Gloves, disposable, latex Laboratory gow n
Emergency Medical Kit Gloves, disposable, latex
Emergency Medical Kit
ood Col lect ion
Ski n Pre para tion & Dis infe ctio n Blo od Collection
'1. Ski n Pre para tion & Disinfection
Cot ton I Gauze
Isop rop yl Alcohol, 70% · Cot tori / Gauze
Phl ebo tom y . . Isopropyl Alcohol, 70%
' ,Tourniquet 2,1''hlebotomy
· · ·• Surgical Tape Tourniquet
·. ·•. Bloqci Bitgs w I AntiCoagulant SurgiCal Tape . . . . .
.· ;. · 2?0 ml · Smgle ·· B~ood Bag sw/ Ari tico agu lant . ·
'450rnl ·· 250 ml ·. • Single ·
Double
c:. . Triple:. · · . 450 rriL. ·' · · 'Do uble
. Qua dru ple Triple .· . ··
Qup,~iupi~ ·

•·Sti.:;l,<,oh Labels forA BO / Rh Gro up 3; Lab elli ng · . .• .· . . .... . ....


.'~;i•~#cl$::on Labels for Exp1ration Dates·· _Stick-on Labels'forABO I RhG rou p . ·
.. · S.tick-on Labe.lsJor Expiration Dates .
~~~?ftpzez:I;;root Pens . ·
· Mo.iSture-ProofPens· ·
Blood Tra nsm i;sib le Diseases
Scre~ningTests for Blood Transmissible Diseases
Absorbent Papers
Distilled Water
Ethyl Acohol; 30% ·
For cep s·
. orit s equivalent
Laboratory Mat or its equivalent
·Le ns pap er.· .
¥; "U" concavity
) bevel (G18, 19, & 23) Microplates wl "U" concavity ·
·Needles w I o bevel (G18, 19, & 23)
-~~r.·---:.;:.:h-...

Slide Carrier
Slide C ar rie r Syringes, 1-2 ml
Syringes, 1-2 m l Test Tube Racks
Test Tube Racks ood & Blood C om po ne
nt s
. Pr ov is io n of Whole Bl
& R ed B lo od Cells Transfer bags
si on of W ho le B lo od
Transfer ba gs & D is tri bu tio n of W ho le Bloo
d&
. Tra.nspo 1rt Is su an ce
& tr ib ut io n of Whole. B lo od &
>port, Is su an ce D is B lo od Produc.t cks or iee bags
Blood C el ls .Cold Box w ith cold pa
ck s or ice ba gs oks
'c ol d Box w ith cold pa Lqgbooks I Record bo
books
:;Logbooks I Record
IL H os pi ta l ~ Based
ove pl t)s th e fo llo w in g: ..··· ·
w in g: ' . ··All th os e st at ed in ab -., ··- .:
. ab ov e pl us th e fo llo ·. '- . --:::.- : ·. . -..,..._<_
-,
1. B io sa fe ty ··
· ·P er so nn el pr ot ec tio n'
', > •
Laboratory goVtltl .. ·
tex:.
Gloves!·disp9sable! .• Ia ·,;.
,;.

r C om pa tib ili ty 1'~~ti


ng
· Fo
· .·. . .
). 'fe st Pr oc ed ur e ·
sposable
.,. · . , }?Jpett~,Pasteur,. di .. .
Test Tube rackS .· lution (NSS ; Sterile)
No~a
·· . , l Salin
e So
..
SS, Sterile)
m6rma._,I·.· Salii:le Solu. tion (N
.~'""·---·- - ' ' - .
'·-·
. ...
2. Forms l Records ood & Compatibility Te
sting
ility Testing Request Forms for Bl
for Blood & Compatib tibility Testing
~-;Request Form5 R es ul t Forms of Compa
ty Testing · Transfusion Forms
Forms of Compatibili
· Worksheets
Transfusion Forms
Worksheets · Logbooks
Logbooks
-~~r.·---:.;:.:h-...

Slide Carrier
Slide C ar rie r Syringes, 1-2 ml
Syringes, 1-2 m l Test Tube Racks
Test Tube Racks ood & Blood C om po ne
nt s
. Pr ov is io n of Whole Bl
& R ed B lo od Cells Transfer bags
si on of W ho le B lo od
Transfer ba gs & D is tri bu tio n of W ho le Bloo
d&
. Tra.nspo 1rt Is su an ce
& tr ib ut io n of Whole. B lo od &
>port, Is su an ce D is B lo od Produc.t cks or iee bags
Blood C el ls .Cold Box w ith cold pa
ck s or ice ba gs oks
'c ol d Box w ith cold pa Lqgbooks I Record bo
books
:;Logbooks I Record
IL H os pi ta l ~ Based
ove pl t)s th e fo llo w in g: ..··· ·
w in g: ' . ··All th os e st at ed in ab -., ··- .:
. ab ov e pl us th e fo llo ·. '- . --:::.- : ·. . -..,..._<_
-,
1. B io sa fe ty ··
· ·P er so nn el pr ot ec tio n'
', > •
Laboratory goVtltl .. ·
tex:.
Gloves!·disp9sable! .• Ia ·,;.
,;.

r C om pa tib ili ty 1'~~ti


ng
· Fo
· .·. . .
). 'fe st Pr oc ed ur e ·
sposable
.,. · . , }?Jpett~,Pasteur,. di .. .
Test Tube rackS .· lution (NSS ; Sterile)
No~a
·· . , l Salin
e So
..
SS, Sterile)
m6rma._,I·.· Salii:le Solu. tion (N
.~'""·---·- - ' ' - .
'·-·
. ...
2. Forms l Records ood & Compatibility Te
sting
ility Testing Request Forms for Bl
for Blood & Compatib tibility Testing
~-;Request Form5 R es ul t Forms of Compa
ty Testing · Transfusion Forms
Forms of Compatibili
· Worksheets
Transfusion Forms
Worksheets · Logbooks
Logbooks

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