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May 12, 1998

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

SUBJECT : ftmendment toSections 26 to 32 of Administrative · · Ofd.er_No. 9 · s: · 1995 to 'be known as Requirements

fJ.nd Procedures tor a License to Operate a Blood· Bank I ,Blood (;enter in the Philippines

Provisions of ChapterVIIJ Section 26 to 32 of the. Administrative Order No, 9 series of 1995 dated April 28; 1995: Rulesand 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/Biood Center (BB/BC) in the Philippines". · ·

Section 1 •. TITLE : IJ f · This Admif1istrative. Order_·. shall be known as 'Requirements and

ProcedurE!s for a License to Operate a Blood Bank I Blood Center (BB I BC) in! he! Philippines". ·

Section 2. ~E~ud,TORY AUTHORITY ' __ ;_· __ :_:_-_::_:.-. __ · .. ;/;::_·:_:·-__ .·- ' ' . '.·" __ .;-·: . _· ____ .·

.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 technical and administrative

· reqtjirementsrelated to licensing andregulation. ·;- -.- . ' ~;:.; ' .

Section 3 . Pl.Jl:i-R0$E

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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:' ·.-;_.; ; ''> i ,' .

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

Category A· .. · (Non Jlospital-Bas~d)

1. Recruitment andretentionofvoluntary 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.blood an.d packed red blood cells 7. Storage of whole blood and papked red blood cells 8. Issuance, transportand 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$sible 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{CategoryB -Non Hospital-Based) 2. Compatibility testing . ··. ·· · ... · ..... . : ... 3. Preliminary investigatiopqfJrari~fusion reactions 4. Resolution of irii::or:Jipatible{,pr6ssmatphes ·

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""''nnmlic:h,,rl and notarized Petition 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 1 0): 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)

d.

. , $ecurities and Exchange Commission · . Begisiration · ·

c.2. •. If Single Proprietorship I Ownership Certified True Copy of (DTI) Domestic Trade ·

. andJnductry Registration . - . .

. Photocopies of PAC Certificates of Personnel of the

. Blood Service· Facilities, · d.1 · Additional requiremE:Jntfor the Head of the

• Blood Bank I Blood Center

... JfPatholbgist, Specialty Board Certificate · · · · issued by the Philippine Board of .. ·.· .. · .Pathologist ; · . ·.'If. Hematologist, Specialty Board Certificate

· issued by the Philippine Board of '. Aerna:tology and Blood Transfusion ,

·. e. L0cafi()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

.. · . . 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. ·

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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 ..

-... ·.·:. -;- . 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~nor RecrtdtmentOffiC: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:) technical or working area shall be exclusively for the use ofthe blood bank/center and its other related activities.

7 .1.2 A Equjprnents, Reagents, Glassware & Supplies

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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 equipment I instruments, . reagents, glass..yare and s!lpplies necessary 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 .··. Documents

a. . Ouly accomplished}l.pplication Form for Renewal of . License(BRL-BSF(BB/BC) Form No.2),

b. ChahgesiHthe li~t bf authorized Blood Collection Units and 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 . ' . - ' '- .

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

· Annual Aqbbrnplishment Report on Blood Services of the · pre\iious year, ·

. ,: . ·--· .,- . . . . . . - . . . .

.. ·Names alld ~ddresses ·of blood donors with rare blood · · types!

DocumenJed changes in Blood l3anking Standard · . Ope1rating Procedures,

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 (P600.00) · 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 (P400.00) shall be .. · charged for every accept~d ?PPiication forrenewal 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

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9. TERMS AND tONDITIONS OF LICENSING . . - - ', ' --- -- •' -:---.' ;,-, -. .

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. · ·

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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 Hospital­Based) 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; · · · • · · ·

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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. _- -.~: ---:---- _:::-._. --- ·; :·- - .·. . -_ --- _- ·-

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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"'BSFi (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 andjvaluate;tiie documents for completeness and authenticity ... lf 'complete, application is accepted .and· approyed: A ciiarge,slip is issued and the applicant 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:/ heroHtems for. compliance and with a directive to cor'r)piete said 'items for compli<J,nce within such period of time as ITla{bewamihted under the·,.cfrcumstances. '- -:- -' ·-- . ' •.· . ' '- :.

a, ·Ass~ssment of a Blood 13,ank/Biood Center for new license to · op~rat(,) .and renewal ofliqense 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 ,satisfactorily 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 Sta~dards forBlood Banks/Centers, 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) . · . >,; ..

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.. 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 .

,.~: ... Bios~fety andWasteManagement Manual ' . . . . . .

Technical Procedures Manual (Technical SOPs)

·.· · ;4, • • · Equipm~ntMaintenance & Repair Logbook I Record .. -:.-. . . -- ,-_ •' ;, . •''/

5:. · ()LiaiJiy. MahagernehtRecords

···Fle~~rds .of BkJod.·Donations

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· 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

R13cords of B,lood Transfusion . . '8.1:·.·.· Recordsqf BloodTransfusion Requests

•·· s.2 .· 'f'le¢Qrds,c)fCorripatibifityTests . 8.3, : f1ec0rds•c)Ussue for Trarist4sion

· .8.4 Records ofTransfusiori Complications

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He<concts <::>t E1mel'ge11cy Issue of Blood .· Transport Re<~onjs Records of Blood .and Components Received · .. from Other Facilities

·.·to. Records of Errors and Accidents ·· ·•. 11. . Summary Records

11 .1 Annual Blood Collection and Utilization :-.- ··.

1 0.3.2 ,E:Hernal Quality ~ssessment . ThE;! BRL sball condllct a yearly External Quality Assessment l ProfiCiency Testing to alllicerised blood bank I center. A blood . barik r center who got a satisfactory rating will be given a . quality Assurance Citation Certificate. Supervisory visits will be conducted as· necessary fo blood bar1ks J centers who tailed in th~·External Quality Assessment.·.· · · / ·.=· '.

Section 11 ISSUANCE <lF LICENSE lmmediatelyaft~r appr()val and evaluation, license is prepared and issued dir~c'tly to the Head of the Blood Bank or his representative (personally of by mail). · ·

Section 12 VALIDITY ~~:LIC~NSE Each license. shalL expire on its ar1ili\fersar{ date of the year stated. .. Section 13 TRANSITION .PERIOD FOF(.CONFIRMATION OF LICENSES

May 28, 199,8 to Juiy·31;:.19QS shall be the transition period for confirmation of compliance to ttie .. nei,V licensure requirements of existing Blood Banks /,Blood Centers fOIJO:wing the new BSF categorization. The BRLcOLRD .·shall. issue. centiticates to existing blood service facilities based on the NVBSP '-Biq()d Services Network Guidelines to continue operation until confirmation of lic"ln.ses I certificates • of authority to O~ffi~. . ..

Section 14 PUBLICATION OF THE LIST OF LICENSED BLOOD BANKS/ CENTERS

An annual updated .list .()f libens53d blood banks/ centers shall be published at leastonce ayearjn a newspaper of general circulation. . -~

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15.1 lnadditiot'l'tdA.o,No. 9 s. 1995,Chapter x, Sec. 47, Item 1, Documented blood collection fron:r paid. donors; blood collection without the superyisipg.ot'a physici?n; non"performance of the required blood

. testing; and disposal ()fblood unjt~,to unauthorized persons shall be a · cause for tbe. cancellat[on, revocation or suspension of the license.

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- - . ·Section 16 ·APPEALS AND RI:PbRTS ON VHJLATIONS · ReportS\b~ ~io]~tion.ofHA7719 and these Rules and R~gulations shall be addre~~~(:!Jo. ~he· $ecretary. of f-l~alth and the Director of the Bureau of Re.search and .Laboratgries. · · The $ecr~tary or tMDir~ctor 6fBRL may request for Police Assistance and tne Natiqrial Bureau of Investigation and/or. the Philippine National l?olicefonthe effective inforcement of RA 7719 and these. Implementing Rules ari(j Regqlations.. ··· . . _., -: ·::· ., . :: ~,;

. Section 17 REPEALiNG .CLAuse.· These re~uirements and prp(::edures shall supersede Sections 26-32, ChapterVIIfofAdministrative Order No. 9 s, 1995, andrelated Bureau Orders and<Circulars 6ftheD~paqrnentThe .. provisions of any of these issuances)nt::onsistentwith 'this administrative order are hereby repealed

or modifiedaccordingly. . . . .. . Section 18 iFF~CTIVI'TY CLAlJSE

. These requirement~·afld . proce;ufes shall take effect May 28, 1998. A · Transition Period of. §{.)days .from date of,. effectivity of this order shall be the trans.ition period for" confirmation of compliance to these licensing requirement~ a'nd.p(ocedure. · . . .

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

MPH, CESO

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. Table 1- BB I BC MINI MUM BANK I CENTER CATEGORY A

~!H!ospital - Based

Bank Refrigerator controlled at 1~6 C: with temperature recorder, alarm system,&· automatic voltage. _"f _.·,_- .

: . }\gglutinationviewer for ABO/RH grouping (tube method) Blood donation couch or bed :1lrgical instruments: forceps, scissors· Hemoglobin pete~ination . l. bJCyanmethell}oglobll1. Method: iphotometer /Heinocue · by Copper SulfateMethod

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~J:!;ilergency Generator powerunit(at least 20 KVA) ~l\1icroplate Ti:ay Viewer for .P A Method _Clinical centrifuge '\Centrifuge for Quantitative Buff)i Coat Method for Malaria detection

BLOOD BANK I CENTER CATEGORY B I. Non-Hospi.tal- Based

Blood Bank Refrigerator controlled at 1-6 C with-temperature ·recorder, alarm system, & ·automatic voltage . regulator · Agglutination viewer for ABO /RH grouping (tubemethod) · · · Blood donation couch or bed • . Surgical instruments: forceps, scissors ·For Hemoglobin I)eterminatio~ .. · ·· 1. by Cyar\J:rlethemoglobfu Method: . ·.Spectrophotometer·/ I-lem&cue i · · 2. 9Y Copper Sulfate_Method ··· l'ycnometer .·. • · · . . · · .·.·••·•.. . Laboratory Oven (fqr Instrument Drying Purposes) Sphygmomanon:\eter

Stethoscope Thermometers·

- · · Room Thermometer- · Laboratory Thermometer Clinical Thermometer Weighing Scales for Blood Donors for Blood Units Autoclave.

Emergency Generator power unit (at least 20 KVA) Microplate Tray Viewer for PA Method Clinical centrifuge Centrifuge for Quantitative BuffJCoat Method for Malaria detection· · · Refrigerated C:entrifugew/ AVR~- .•

'-'V·<

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Table 1 - BB I BC MINI MUM BANK I CENTER CATEGORY A

':;~';,Hal" Based

~Equipment set w I AVR

including heating block diluter w I Go-no-Go tester set ioscope, Binocular with Oil Immersion Objective with UV Paralens adapter for Malaria ,site Detection

)watch or T1mer ferbathw/thermometer (lO~lOOC)

above plus the following : C~ntrifuge

~rJ?~.th controlled at 37C (for crossmatching) · Drybath

I INSTRUMENTS BLOOD BANK I CENTER

. I. Non-Hospital -Based

. EIA Equipment set w I AVR EIAreader with printer EIAwasher Incubator including heatingblock Microdiluter w I Go-no-Go tester set Microscope, Binocular, with ·

B

UV Para! ens adaptefwithOil hnmersion Objective forMaJaria P~f~site Detection . Pipettor, 10~100ul · PlasmaEi<tractor · ·.· Plat~l~t Rotator , . ·Reagent Re,frigeratot wl A VR &.thennometer Rotatprfor RPR/Vl)RL ·. . . StopWatch or11irler ·: ·

.• Waterbath w I thermometer (10-lQOC)

II. Hospital ~ Based ·

All those stated above plus the following:· Serologic Centrifuge Waterbath controlled at 37C (for crossmatching) Water or Dry bath.

Table 2- BB IBC · MINI MUM REQUIREMENTS FOR REAGENTS

BLOOD BANK I CENTER CATEGORY A !on-Hospital-Based

[~moglobin Determination -by CuSo4 Method

'.CuSo4 Solution, Sp. Gr. of 1.053 Distilled Water

~by Cyanmethemoglobin Method Drabk~ Reagent · [eri:loglobin Standard

-FniW~rcl Typing (slide/tube method)

sera -Reverse Typi~g (tube lll.ethod)c

with-:appropriate cbnfi"Ol'

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zt~J.tl.fef,. of. the. foil owing) y-......... ,_,_ & Thin Smear

Quantitative Buffy Coat Method

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BLOOD BANK I CENTER CATEGORY B I. Non-Hospital- Based

For Hemoglobin Determination ·· -by CuSo4 Method

Ct.iSo4 Solution, Sp. Gr. of 1.053 Distilled Water

-by Cyanmethemoglobin Method ·orabkins Reagent · · · Hemoglobin Standard

'For ABO 2rouping "' .> .. , ·. . . . . .. . . •· .... · -Fpryvard~';f)>ping (slide/tube :lllethod) .. ·. · .. 4uti7ATypingsera · · · Anti-B Typing sera .. . . · · · . . . . ' . "ReyerseTyping (tube method). · · KnownAcells • · · · I<rtowri B cells ··

. For Rh.Typing·(tube method)' · ·· · · ·· · · Anti-D with appropriate control

For Infectious Disease Testing ·

A. Malaria (either of the following) "Thick& Thin Smear

Giemsa -Wright's Stain . Buffer water

· -Quantitative Buffy Coat Method QBC Reagent kit

'·::~1-':·.<.;~f:> .. _· _._ .. , _:_:__:_:..:_ _. __ · _:___

,:~;}~,,_.,, ... ~...,,~ ...... ,...--~~--v•-..•-••"'~~·'"' '•"•-"'--•·•--~.,..---.,w-'-·~···--··~·-----

Table 2- BB IBC . MINI MUM REQUIREMENTS FOR REAGENTS LUUU BANK I CENTER CATEGORY A

;t:reening Test for Syphilis

or

$creening Test for HIV-Ab

or

..

Known A Cells

or or

Known B Cells. 22o/oBovineSerun1AJburnin Anti-Human Globulin Reagent

BLOOD BANK I CENTER CATEGORY B. B. Screening Test for Syphilis

.· VDRL Test Kit or .· . RPR Card Test Kit

C. Screening Test for HIV-Ab .

HIV 1& 2 PA Test Kit or ·. HIV 1&2 EIA Kit or .. · D~ Screening Test forHBs.Ag/

EIA Testi<it

E. Scr~e~ing Testfor HCy'-Ab

EIATestKit PATestKif·•····.··

It Hospital-Based

or

All those stated above pi tiS .the following : For Compatibility Testing ·. -Crossmatching .

Known A Cells Known B Cells 22%BovineSerumAlbumin Anti-Human Globulin ~eagent _

<v ;0/'

·· ...

/

l l . ' '

. _j.

,:~;}~,,_.,, ... ~...,,~ ...... ,...--~~--v•-..•-••"'~~·'"' '•"•-"'--•·•--~.,..---.,w-'-·~···--··~·-----

Table 2- BB IBC . MINI MUM REQUIREMENTS FOR REAGENTS LUUU BANK I CENTER CATEGORY A

;t:reening Test for Syphilis

or

$creening Test for HIV-Ab

or

..

Known A Cells

or or

Known B Cells. 22o/oBovineSerun1AJburnin Anti-Human Globulin Reagent

BLOOD BANK I CENTER CATEGORY B. B. Screening Test for Syphilis

.· VDRL Test Kit or .· . RPR Card Test Kit

C. Screening Test for HIV-Ab .

HIV 1& 2 PA Test Kit or ·. HIV 1&2 EIA Kit or .. · D~ Screening Test forHBs.Ag/

EIA Testi<it

E. Scr~e~ing Testfor HCy'-Ab

EIATestKit PATestKif·•····.··

It Hospital-Based

or

All those stated above pi tiS .the following : For Compatibility Testing ·. -Crossmatching .

Known A Cells Known B Cells 22%BovineSerumAlbumin Anti-Human Globulin ~eagent _

<v ;0/'

·· ...

/

l l . ' '

. _j.

Table 2- BB./BC MINI MUM REQUIREMENTS FOR REAGENTS r>.n:n BANK I CENTER CATEGORY A

- .

BLOOD BANK I CENTER CATEGORY B

For Preliminary Investigation of Transfusion Reactions . Compatibility Testing ·1. ABO Grouping .· ·. -ForwardTyping (slide/tube method) · Anti-ATypmg sera · · · · AnticB Typing sera . .· , .. · .. · -Reverse .Typing (tube method) •..• ·Known A cells ·· · · .· ··· Known B cells ·

. ·.·... . ··:

... 2. Jlli 'fy'pirlg (t!J,be itlethod) .. · ,.· . .. . ·-.. AntFP with appt()priate control . . . . .

-~ . . . , .

.. -. '•,' •, _;

. · 3. Ciossmatching ·

·.Known A Cells · KnownB Cells ..•. · ; . · · 22"/oBovine Si'!tl.lmAlbi.imin Anti"Human Globulin Reagent · 4. BacterialCuiture (c/o Clinical Laboratory) For Complete Investigation of Transfusion Reactions (refer to Reference Laboratory) · 1. AntibodvldenHficatiort

•· ·------~-·

··.-

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(Information, Education, & Campaign) Materials:

Education.& Councelling iEC Materials

)~.$election andScreenirig :boriorDedaration Form Donor lvl:edital:History & . · PJ:i.ysical Examination Forms.

:ISo?roi>vlAlcohol, 70% . ·. . . . needles, disposaples ~ipefte, disposable,plastic .·. :'

~ouping (Slide Method) \.pplical:or Sticks ~orii:i.a1 Saliz1e Solution(NSS, Sterile) i~~---t-·::·\.

· Disposal ~odium Hypochlorite Solution :J:3ioha'z.ard Plastic Bags :~olor-coded Plastic Disposable Trash Bags

IEC (Information, Education, & Campaign) Materials: ·Posters

· Leaflets Brochures

Health Education & Councelling IEC Materials . · Posters Leaflets Brochures

Donor. SeleCtion andScr;~erting DonorDeCiaratio'n•Form ·. Donor'Medic~LHJ;tory & · · • ·Physical Ex'iiminatiori Forms · '•" ,.,. .. .,- . ·_·,·.,

Hen.toglobiri Det.?J.miriation: . · . . Lancet · · · · · .·· · Tourniquet · lsopropy1Alcohol,1Q;/o · · Syringesw /rieeales,disposables Pipette, disposable, plastic Pipette tips ..

ABO Grouping (Slicie Method) Applicator Sticks Normal SalineSolution (NSS, Sterile) Proper Waste Disposal Sodium Hypochlorite Solution

.:; :

Biohazard Plastic Bags . .

Color-coded Plastic Disposable Tras~ ·--'--'---_L---

~-~·--

- --------- --

~'-:':-·..:-}.;>•:'

____________---· ·~

··-

iosafety Personnel protection Laboratory gown Gloves, disposable, latex Emergency Medical Kit

ood Collection Skin Preparation & Disinfection

Cotton I Gauze Isopropyl Alcohol, 70%

Phlebotomy ' ,Tourniquet

· ···• Surgical Tape ·. · •. Bloqci Bitgs w I AntiCoagulant

.· ;. ·· 2?0ml · Smgle ·· '450rnl Double

c:. . Triple:. · · . Quadruple

•·Sti.:;l,<,oh Labels forABO/ Rh Group .'~;i•~#cl$::on Labels for Exp1ration Dates·· .. ~~~?ftpzez:I;;root Pens . ·

Blood Transmi;sible Diseases

. orits equivalent

¥; "U" concavity ) bevel (G18, 19, & 23)

Biosafety Personnel protection Laboratory gown Gloves, disposable, latex Emergency Medical Kit

Blood Collection '1. Skin Preparation & Disinfection

· Cottori/ Gauze . . Isopropyl Alcohol, 70%

2,1''hlebotomy Tourniquet SurgiCal Tape .. . . . . B~ood Bagsw/Ariticoagulant . ·

·· 250 ml ·..• Single · . 450 rriL. ·' · · 'Double

Triple .· .. ·· Qup,~iupi~ ·

,, ~·~..;_._.~ ... -:-•. ::~~~£/'W&fii

3; Labelling · . .• .··. . . . . .. . .... _Stick-on Labels'forABO I RhGroup . ·

· S.tick-on Labe.lsJor Expiration Dates . · Mo.iSture-ProofPens· ·

Scre~ningTests for Blood Transmissible Diseases Absorbent Papers Distilled Water Ethyl Acohol; 30% · Forceps· Laboratory Mat or its equivalent

·Lens paper.·. Microplates wl "U" concavity ·

·Needles w I o bevel (G18, 19, & 23)

Slide Carrier

Syringes, 1-2 ml

Test Tube Racks

-~~r.·---:.;:.:h-...

sion of Whole Blood & Red Blood Cells

Transfer bags

>port, Issuance & Distribution of Whole. Blood & .

Blood Cells 'cold Box with cold packs or ice bags

:;Logbooks I Record books

. above plus the following: ' .

.,.

m6rma.I Salii:le Solution (NSS, Sterile) .~'""·---·- - _, ·.· ' ' - . .

'·-·

~-;Request Form5 for Blood & Compatibility Testing

Forms of Compatibility Testing ·

Transfusion Forms ·

Worksheets ·

Logbooks

Slide Carrier

Syringes, 1-2 ml

Test Tube Racks

. Provision of Whole Blood & Blood Components

Transfer bags

Tra.nsport1 Issuance & Distribution of Whole Blood &

Blood Produc.t .Cold Box with cold packs or iee bags

Lqgbooks I Record books

IL Hospital ~ Based

··All those stated in above plt)s the following: .. ··· · -.,··-.:

.

·. '- . --:::.- : ·. . -..,..._<_

1. Biosafety · · -,

· ·Personnel protection'

Laboratory goVtltl .. · ' , > •

Gloves!·disp9sable! .• Iatex:.

· For Compatibility 1'~~ting

). 'festProcedure · · .·. .. .

·,;.

· . , }?Jpett~,Pasteur,. disposable

Test Tube rackS .· .. .

· · . No~al Saline Solution (NSS; Sterile) .. ,

2. Forms l Records . . ..

Request Forms for Blood & Compatibility Testing

Result Forms of Compatibility Testing

Transfusion Forms

Worksheets

Logbooks

,;.

Slide Carrier

Syringes, 1-2 ml

Test Tube Racks

-~~r.·---:.;:.:h-...

sion of Whole Blood & Red Blood Cells

Transfer bags

>port, Issuance & Distribution of Whole. Blood & .

Blood Cells 'cold Box with cold packs or ice bags

:;Logbooks I Record books

. above plus the following: ' .

.,.

m6rma.I Salii:le Solution (NSS, Sterile) .~'""·---·- - _, ·.· ' ' - . .

'·-·

~-;Request Form5 for Blood & Compatibility Testing

Forms of Compatibility Testing ·

Transfusion Forms ·

Worksheets ·

Logbooks

Slide Carrier

Syringes, 1-2 ml

Test Tube Racks

. Provision of Whole Blood & Blood Components

Transfer bags

Tra.nsport1 Issuance & Distribution of Whole Blood &

Blood Produc.t .Cold Box with cold packs or iee bags

Lqgbooks I Record books

IL Hospital ~ Based

··All those stated in above plt)s the following: .. ··· · -.,··-.:

.

·. '- . --:::.- : ·. . -..,..._<_

1. Biosafety · · -,

· ·Personnel protection'

Laboratory goVtltl .. · ' , > •

Gloves!·disp9sable! .• Iatex:.

· For Compatibility 1'~~ting

). 'festProcedure · · .·. .. .

·,;.

· . , }?Jpett~,Pasteur,. disposable

Test Tube rackS .· .. .

· · . No~al Saline Solution (NSS; Sterile) .. ,

2. Forms l Records . . ..

Request Forms for Blood & Compatibility Testing

Result Forms of Compatibility Testing

Transfusion Forms

Worksheets

Logbooks

,;.