FDA Blood Bank & Blood Tranfusion

8/11/2019 FDA Blood Bank & Blood Tranfusion

1/44

FDA BLOOD BANK INSPECTION GUIDE

BLOODBOOK.COM

BloodBook.com - Blood Informaton for Lf!"

Pa#! S$mmar%

P&ESENTED ON T'IS PAGE IS AN ACTUAL FDA BLOOD BANK INSPECTION

GUIDE ('IC' (ILL GI)E AN IDEA OF BLOOD BANK INSPECTION ISSUES.

TO 'OME PAGE

Don*t for#!t to +ookmark BloodBook.com" ,CT&L-D

CLOSE (INDO(

T/ 0a#!1 0r!/!nt!d +!lo2 t! r!d ln!1 / dr!ctl% from t! FDA. It #l#t/

0roc!d$r!/ and #$d!ln!/ for n/0!cton of Blood +ank/ and / r!f!r!nc!

mat!ral for n3!/t#ator/ and ot!r FDA 0!r/onn!l. (! a3! not can#!d on!

/n#l! 2ord of t/ doc$m!nt +!lo2 t! r!d ln!. It / 0r!/!nt!d $ncan#!d for

nformatonal 0$r0o/!/ and for a 0ont of r!f!r!nc! a/ %o$ r!ad /om! of t!

mat!ral/ on BloodBook.com Blood Book - END

Blood Bank In/0!cton/

Not!4 T/ doc$m!nt / r!f!r!nc! mat!ral for n3!/t#ator/ and ot!r FDA

0!r/onn!l. T! doc$m!nt do!/ not +nd FDA1 and do!/ no conf!r an% r#t/1

0r3l!#!/1 +!n!5t/1 or mm$nt!/ for or on an% 0!r/on,/.


2/44

GUIDE TO INSPECTIONS OF BLOOD BANKS

TABLE OF CONTENTS

S$+6!ct ................................................................................Pa#!

Introd$cton............................................................................P# 7

G!n!ral Informaton.................................................................P# 7

O0!raton/...............................................................................P# 8

&!cord/...................................................................................P# 8

Error/1 Accd!nt/ and Fatalt!/.................................................P# 8

Faclt!/1 E9$0m!nt and P!r/onn!l...........................................P# :

;$alt% A//$ranc!.....................................................................P# 1 ar! no lon#!r n

!!ct. Con/!9$!ntl%1 5!ld n3!/t#ator/ ar! no lon#!r r!9$r!d to 5ll o$t t!

c!ckl/t d$rn# !/ta+l/m!nt n/0!cton/ nor /$+mt t 2t n/0!ctonal

r!0ort/.

T! c!ckl/t and n/tr$cton +ookl!t 2!r! la/t 0$+l/!d n Ma% 77. Snc!

Ma% 771 CBE& //$!d a n$m+!r of m!moranda to nd$/tr%1 d!0ctn# n!2

r!comm!ndaton/1 and mod5caton/ to 0r!3o$/ #$danc!1 n addton to

#$d!ln!/ on 9$alt% a//$ranc! and 3aldaton of com0$t!r /%/t!m/.

Alto$# t! a#!nc%1 at t! tm! of t/ 0$+lcaton1 / n t! 0roc!// of

r!3/n# t! r!#$laton/ on +lood and +lood 0rod$ct/1 t 2ll tak! /om! tm!

+!for! /$c r!3/on/ ar! n !!ct. T! c$rr!nt #$d! 0ro3d!/ nt!rm

n/0!ctonal dr!cton.

T/ r!f!r!nc! 0ro3d!/ t! mo/t $0dat!d nt!r0r!taton of c!rtan r!#$laton/

and #$d!ln!/. T/ r!f!r!nc! / not nt!nd!d to +! a 'o2 to... t / a

t!cncal r!f!r!nc! and / nt!nd!d to +! $/!d n con6$ncton 2t t!

In/0!cton O0!raton/ Man$al ,IOM1 t! Cod! of F!d!ral &!#$laton/1 Ttl! 87,87 CF&1 t! Com0lanc! Pro#ram for t! In/0!cton of Lc!n/!d and

Unlc!n/!d Blood Bank/ ,CP =:>7 and t! Com0lanc! Polc% G$d!/ for

+olo#c/ ,CPG =7:7

@


5/44

0r!0araton of /$c 0rod$ct/. ;$!/ton/ conc!rnn# 0ractc!/ 2c ma% +!

aardo$/ /o$ld +! addr!//!d to t! D3/on of In/0!cton/ and

S$r3!llanc! ,'FM-@> at ,:>7 @


6/44

d!t!rmn! o2 man% $nt/ of 2ol! +lood and r!d +lood c!ll/ ,&BC/ ar!

r!c!3!d from o$t/d! /o$rc!/ !ac %!ar1 o2 man% ar! a$tolo#o$/ and o2

man% ar! dr!ct!d.

D!t!rmn! 2c 0rod$ct/ ar! 0r!0ar!d and act3t!/ cond$ct!d.

Lc!n/!d !/ta+l/m!nt/ ar! r!9$r!d to r!0ort can#!/ n man$fact$rn# to

CBE&. Som! !/ta+l/m!nt/ /$+mt SOP/ n r!0ortn# t!/! can#!/. Not all

0roc!d$r!/ ar! r!3!2!d +% CBE& t!r!for!1 f an n3!/t#ator o+/!r3!/ a

0roc!d$r! /J! con/d!r/ $n/af! for t! donor or tat 2ll a!ct t! /af!t%1

0$rt%1 or 0ot!nc% of t! 0rod$ct contact t! D3/on of In/0!cton/ and

S$r3!llanc! at ,:>7-@


7/44

lmt!d to1 to/! 2o t!/t r!0!at!dl% r!act3! for ant-'I) or 'B/A# and a3!

not +!!n 0ro0!rl% r!!nt!r!d or a3! a m!dcal /tor% 2c 2o$ld 0r!cl$d!

donaton. T! r!#$laton/ do not 0ro+t 5rm/ from coll!ctn# +lood from

d!f!rr!d donor/. A 5rm ma% coll!ct +lood from d!f!rr!d donor/ f t / not

0r!cl$d!d +% t/ SOP o2!3!r1 t! 5rm m$/t a3! a /%/t!m to 0r!3!nt t!

d/tr+$ton of t!/! +lood com0on!nt/.

&!f!r to FDA r!comm!ndaton/ n c$rr!nt m!moranda to r!#/t!r!d +lood

!/ta+l/m!nt/ andJor t! !/ta+l/m!nt*/ SOP*/ to d!t!rmn! tat t!

a00ro0rat! d/0o/ton of +lood com0on!nt/ and d!f!rral of donor/ occ$r/ for

$nt/ t!/tn# r!0!at!dl% r!act3!.

E&&O&S1 ACCIDENTS AND FATALITIES

&!f!r to CBE&*/ m!morand$m to r!#/t!r!d +lood !/ta+l/m!nt/1 dat!d

Marc 8>1 771 ttl!d &!/0on/+lt!/ of Blood E/ta+l/m!nt/ &!lat!d to

Error/ and Accd!nt/ n t! Man$fact$r! of Blood and Blood Com0on!nt/.

C$rr!ntl%1 t!r! / no r!#$laton tat r!9$r!/ $nlc!n/!d1 r!#/t!r!d +lood

!/ta+l/m!nt/ or tran/f$/on faclt!/ to /$+mt !rror and accd!nt r!0ort/ to

t! FDA. 'o2!3!r1 a toro$# n3!/t#aton and doc$m!ntaton of corr!ct3!acton / r!9$r!d. A r!9$!/t a/ //$!d for $nlc!n/!d faclt!/ and

tran/f$/on /!r3c!/ to 3ol$ntarl% r!0ort !rror/ and accd!nt/.

(!n a com0lcaton of +lood coll!cton or tran/f$/on / con5rm!d to +!

fatal1 t! fatalt% m$/t +! r!0ort!d to t! Oc! of Com0lanc!1 :>7-@


8/44

LOOKBACK POLIC

S!! t! A0rl 8:1 78 m!morand$m1 &!3/!d &!comm!ndaton/ for t!

Pr!3!nton of '$man Imm$nod!5c!nc% )r$/ ,'I) Tran/m//on +% Blood

and Blood Prod$ct/ for addtonal #$danc!.

POST DONATION INFO&MATION &EPO&TS

&!f!r to CBE&*/ m!morand$m to nd$/tr% ttl!d G$danc! &!#ardn# Po/t

Donaton Informaton &!0ort/ dat!d D!c!m+!r 7>1 7:.

FACILITIES1 E;UIPMENT1 PE&SONNEL

FACILITIES

OS'A 0$+l/!d t! 5nal r$l! for t! Occ$0atonal EH0o/$r! to Blood+orn!

Pato#!n/ n t! D!c!m+!r 1 77 F!d!ral &!#/t!r. Incl$d!d n t! r$l! ar!

r!9$r!m!nt/ for faclt!/ to d!3!lo0 0roc!d$r!/ to !n/$r! t! /af!t% of

!m0lo%!!/ 2t a 0ot!ntal for !H0o/$r! to +oaardo$/ mat!ral/ and

0roc!d$r!/ for m!dcal 2a/t! d/0o/al. FDA r!9$r!/ and-2a/n# faclt!/

for /ta dra2n# and andln# +lood and t! /af! and /antar% d/0o/al of

tra/. At /om! mo+l! /t!/ 2!r! and 2a/n# faclt!/ ma% not +!

a3ala+l!1 an alt!rnat! m!tod to cl!an and/1 .!.1 +act!rcdal and 20!/1 /

acc!0ta+l!.

T! C!nt!r/ for D/!a/! Control ,CDC and t! Natonal In/tt$t!/ of '!alt

,NI' 0$+l/!d a +ookl!t !nttl!d Bo/af!t% n Mcro+olo#cal and Bom!dcal

La+orator!/ 2c r!comm!nd/ 0r!ca$ton/ la+orator% !m0lo%!!/ /o$ld

follo2. T! +ookl!t / a3ala+l! tro$# t! D!0artm!nt of '!alt and '$man

S!r3c!/ ,D''S. It / 0$+lcaton No. ,CDC -:@1


9/44

dra2n1 t!r!for!1 t! trac o2 of t! faclt%1 !/0!call% mo+l! /t!/1 m$/t

+! 0ro0!rl% montor!d and controll!d.

T! nt!r3!2 ar!a a/ to o!r t! donor a d!#r!! of 0r3ac% /o tat t!

donor 2ll +! comforta+l! an/2!rn# t! 9$!/ton/ 2to$t f!ar of +!n#

o3!r!ard.

E;UIPMENT

&!f!r to t! CBE& ?$l% 871 78 M!morand$m to lc!n/!d !/ta+l/m!nt/ on

Can#!/ n E9$0m!nt for Proc!//n# Blood Donor Sam0l!/. D/c$//on of

can#!/ n !9$0m!nt for ABOJ&' and ant+od% /cr!!nn# / 0r!/!nt!d $nd!rPart B La+orator% +!lo2.

If !9$0m!nt / $/!d n t! !/ta+l/m!nt tat / not l/t!d n t! CF&1

0!rformanc! c!ck/ and 0r!3!nt3! mant!nanc! /o$ld +! 0!rform!d +% t!

5rm accordn# to t! man$fact$r!r*/ n/tr$cton/ andJor SOP*/.

D$rn# t! co$r/! of an n/0!cton1 t! n3!/t#ator ma% o+/!r3! or r!3!2

n/tanc!/ 2!r! !9$0m!nt or /$00l!/ ar! !t!r +!n# m/$/!d or notf$nctonn# a/ d!/#n!d. B!ca$/! of m/$/!1 or lack of ad!r!nc! to SOP*/

andJor man$fact$rn# n/tr$cton/1 t! $/! of k!% !9$0m!nt or /$00l!/

cr!at!/ crc$m/tanc!/ 2!r! donor1 o0!rator1 or 0rod$ct /af!t% /

com0rom/!d. It / m0ortant to !Hamn! t! 5rm*/ o3!rall $/! of !9$0m!nt

and /$00l!/ to +! c!rtan tat !9$0m!nt and /$00l!/ ar! $/!d accordn# to

dr!cton/1 /at/factorl% n/0!ct!d1 mantan!d and o0!ratn# 0ro0!rl%.

T! /tandardaton and cal+raton of t! !matocrt c!ntrf$#! ma% +! don!

2t a comm!rcall% 0r!0ar!d control or +% ot!r m!tod/1 !.#.1 d$0lcat!/am0l!/ t!/t!d at m$lt0l! nt!r3al/.

S0!ctro0otom!t!r/ $/!d d$rn# 3ral t!/tn# /o$ld +! c!ck!d 0!rodcall%

for ln!art%1 drft and r!0!ata+lt% accordn# to man$fact$r!r*/ n/tr$cton/.


10/44

Lar#!r +lood !/ta+l/m!nt/ ma% a3! 0$rca/!d a c!ntral t!m0!rat$r!

montorn# /%/t!m to montor and r!cord t!m0!rat$r!/ n +lood /tora#!

$nt/. Onc! t! /%/t!m / n/tall!d and t/ acc$rac% d!mon/trat!d and

doc$m!nt!d1 a dal% com0ar/on of t! nt!rnal t!rmom!t!r to t! r!cordn#

cartJd!3c! / not r!9$r!d. 'o2!3!r1 0!rodc 0!rformanc! c!ck/

com0arn# cal+rat!d t!rmom!t!r/ to /%/t!m 0rnto$t/ /o$ld +! 0!rform!dto a//$r! t! /%/t!m / f$nctonn# acc$rat!l%.

Proc!d$r!/ /o$ld 0ro3d! for t! cal+raton of t! a$tocla3! +!for! ntal

$/! and aft!r r!0ar/. Cal+raton 0roc!d$r!/ /o$ld 0ro3d! a//$ranc! tat

t! a$tocla3! f$ncton/ a/ nt!nd!d1 .!.1 /t!rlaton of arm 0r!0araton

/$00l!/ andJor d!contamnaton of +oaardo$/ mat!ral. Bolo#c ndcator/

m$/t +! $/!d 0!rodcall% and a t!m0!rat$r! control1 /$c a/ !at /!n/t3!

ta0!1 /o$ld +! $/!d 2t !ac r$n to 3!rf% tat t! mat!ral/ ar! +!n#

/t!rl!d. A mnm$m of 787.@oC ,8@7oF for > mn$t!/ +% /at$rat!d /t!amat a 0r!//$r! of 7@ atmo/0!r!/ / r!comm!nd!d for mat!ral/ contamnat!d

2t +lood 8> mn$t!/ at t! /am! t!m0!rat$r! / r!9$r!d for arm

0r!0araton /$00l!/.

PE&SONNEL

Blood +ank 0!r/onn!l /o$ld +! famlar 2t a00lca+l! r!#$laton/ r!lat!d to

t!r r!/0!ct3! ta/k/. P!r/onn!l /o$ld kno2 t! locaton of t! SOP man$aland +! kno2l!d#!a+l! a+o$t to/! /!cton/ 2c 0!rtan to t!r 6o+/.

Sta of mo+l! /t!/ m$/t a3! t! /am! d!#r!! of trann# and /$0!r3/on

a/ for 5H!d donor /t!/ locat!d n t! +lood +ank or n a donor c!nt!r.

)ol$nt!!r/ ar! 0!rmtt!d to a///t n 3aro$/ ar!a/ and m$/t +! ad!9$at!l%

tran!d. Trann# /o$ld +! doc$m!nt!d.

;UALIT ASSU&ANCE

&!f!r to t! Draft G$d!ln! for ;$alt% A//$ranc! n Blood E/ta+l/m!nt/1

dat!d ?$n! 7=1 7:.


11/44


12/44

:. D!f!rral of Blood and Pla/ma Donor/ +a/!d on M!dcaton/1 dat!d ?$l%

81 7:.


13/44

al/o +! a3ala+l! tat 0!rmt comm$ncaton of t/ nformaton to 3/$all%

m0ar!d1 llt!rat!1 or non-En#l/ /0!akn# 0!r/on/ f t!% ar! 0!rmtt!d to

donat!. T! 0roc!d$r!/ a00l!d /o$ld 0ro3d! an o00ort$nt% at !ac 3/t

for t! donor to con/d!r t! nformaton and to mak! an nform!d d!c/on

a+o$t 2!t!r to donat!. .:

DONO& 'ISTO&

T!m0!rat$r!1 Blood Pr!//$r!4 T! /$##!/t!d normal +lood 0r!//$r! 3al$! /

>-7> mmJ@>-7>> mm. A lo2 t!m0!rat$r! / $/$all% of no /#n5canc!

$nl!// t! donor a/ /%m0tom/ of 3ral lln!//. T!m0!rat$r! con3!r/on4 oF

,oC H J@ :8 oC ,oF - :8 H @J. A t!m0!rat$r! on t! da% of donaton

.oF ,:=.@oC 2o$ld t!m0orarl% d!f!r a donor. A t!m0!rat$r! of oF

,:=.8oC for mor! tan a 7> da%/ /o$ld +! !3al$at!d +!for! donaton 2o$ld

+! allo2!d.

Ac$t! &!/0rator% D/!a/!/4 S%m0tom/ of r!/0rator% d/!a/! ,cold/1

n$!na1 0!r//t!nt co$#1 /or! troat or ot!r manf!/taton/ of $00!r

r!/0rator% d/!a/! /all +! ca$/! for r!6!cton $ntl act3! /%m0tom/ a3!

/$+/d!d. S$c /%m0tom/ ma% +! an !arl% ndcaton of a mor! /!ro$/

lln!//.

Ot!r Ac$t! and Cronc D/9$alf%n# D/!a/!/4 Con3$l/on/1 +l!!dn#

d/ord!r/1 r!c!nt toot !Htracton ,2tn =8 o$r/1 malara1 /kn nf!cton at

t! 0l!+otom% /t!1 canc!r1 t$+!rc$lo//1 da+!t!/1 and !art d/!a/! /o$ld

+! ca$/! for r!6!cton.

Inf!cto$/ Skn D/!a/!/4 Mld /kn d/ord!r/ /$c a/ acn!1 0/ora//1 or t!

ra/ of 0o/on 3% ar! not ca$/! for d!f!rral $nl!// t!% a!ct t! /kn n t!

0l!+otom% ar!a. Donor/ 2t +ol/ or ot!r /!3!r! /kn nf!cton/ /o$ld +!

d!f!rr!d $ntl t! 0l!+otom% ar!a / fr!! of nf!cton. Malara4 S!! t! ?$l%

81 7< m!morand$m1 &!comm!ndaton/ for D!f!rral of Donor/ for Malara

&/k1 for addtonal #$danc!. CDC 0ro3d!/ a +ookl!t1 '!alt Informaton

for Int!rnatonal Tra3!l!r/1 2c /o$ld +! $/!d rat!r tan t! ma0/ tat

2!r! onc! $/!d. T/ +ookl!t / $0dat!d %!arl% and t! 5rm /o$ld +! $/n# a

r!c!nt !dton.


14/44

Pla/ma0!r!// donaton/ tat ar! al/o $/!d for t! 0r!0araton of Plat!l!t/

ar! not !H!m0t!d from t! malara r!/trcton/.

'!0att/4 Donor/ 2o a3! ad clo/! contact 2t a 0at!nt 2t 3ral

!0att/ /o$ld +! d!f!rr!d for at l!a/t t2!l3! mont/. 'o/0tal 0!r/onn!l

2orkn# n ar!a/ 2!r! !0att/ / !nd!mc1 /$c a/ r!nal dal%// $nt/1

/o$ld +! !Hcl$d!d for at l!a/t t2!l3! mont/ aft!r !m0lo%m!nt n /$c

ar!a/. Pro/0!ct3! donor/ 2o a3! r!c!3!d 'BIG follo2n# a !0att/

!H0o/$r! /o$ld +! d!f!rr!d for at l!a/t 78 mont/.

Ac$0$nct$r! 0at!nt/ ma% donat! +lood 2to$t a t2!l3! mont d!f!rral f

t! n!!dl!/ $/!d a3! +!!n /t!rl!d $nd!r 0ro0!r condton/. If t! n!!dl!/t!rlaton 0roc!d$r! cannot +! 3!r5!d +% t! +lood +ank1 t! donor /o$ld

+! d!f!rr!d for t2!l3! mont/. T! /am! 0rnc0l! can +! a00l!d to !ar or

ot!r +od% 0!rcn#. If /t!rl! 0roc!d$r!/ can +! 3!r5!d to a3! +!!n $/!d1

t! donor n!!d not +! d!f!rr!d.

Donor/ 2o a3! +!!n !H0o/!d to +lood 0!rc$tan!o$/l%1 .!.1 n!!dl!/tck/ or

m$co$/ m!m+ran! /0la/!/1 /o$ld +! d!f!rr!d from donatn# +lood for at

l!a/t t2!l3! mont/.

Donor/ 2o a3! r!c!3!d a $nt of +lood1 +lood com0on!nt1 or d!r3at3!

,ot!r tan clottn# factor d!r3at3!/ 2c ma% +! a 0o//+l! /o$rc! of

nf!cto$/ d/!a/! ar! d!f!rr!d for t2!l3! mont/ aft!r r!c!0t of t! 0rod$ct.

A m!morand$m notf%n# all +lood !/ta+l/m!nt/ r!#ardn# d!f!rral/ for

m!dcaton/ ncl$dn# Acc$tan!1 T!#/on1 Pro/car and 0t$tar% '$man Gro2t

'ormon! 2a/ //$!d ?$l% 81 7:1 D!f!rral of Blood and Pla/ma Donor/

+a/!d on M!dcaton/. If a donor admt/ to takn# m!dcaton/1 .!.1 a/0rn orant+otc/1 t!r! /o$ld +! f$rt!r 9$!/tonn# of t! donor to d!t!rmn! t!

r!a/on for takn# t! m!dcaton tat m#t 0r!cl$d! donaton ,.!.1 a/0rn

for f!3!r or ant+otc for nf!cton.

An acc!0ta+l! r!f!r!nc! for dr$#Jm!dcaton d!f!rral / t! Dr$# U/! and


15/44

Blood Donor Acc!0ta+lt% G$d!1 C$tt!r Bolo#cal1 7:.

Dr!ct!d Donor/4 /o$ld m!!t all /$ta+lt% r!9$r!m!nt/ and +! t!/t!d a/

allo#!n!c donor/. Occa/onall%1 a dr!ct!d donaton ma% not m!!t all

/$ta+lt% and t!/tn# r!9$r!m!nt/1 n 2c ca/!1 t! 0at!nt*/ 0%/can

ma% mak! a m!dcal d!c/on to $/! t! dr!ct!d donaton.

SC&EENING A&EA ;UALIT CONT&OL

T! contan!r/ for t! co00!r /$lfat! ,C$SO@: C$SO< !9$3al!nt to 7:.@ #mJdl

!mo#lo+n a/ a /0!c5c #ra3t% of 7.>@@. T! /0!c5c #ra3t% /o$ld +!

c!ck!d 0!rodcall% 2t a cal+rat!d %drom!t!r.

If t!r! / no cl!ar d/tncton +!t2!!n acc!0ta+l! and $nacc!0ta+l! donor/1

t! /ol$ton/ /o$ld +! can#!d1 or a d!r!nt m!tod of /cr!!nn# donor/

/o$ld +! con/d!r!d. Co00!r /$lfat! /cr!!nn# / not a 9$anttat3!

0roc!d$r!. S0!c5c m!a/$r!m!nt of !mo#lo+n or !matocrt ma% ndcat!

tat a donor r!6!ct!d +% t! co00!r /$lfat! 0roc!d$r! /1 aft!r all1 acc!0ta+l!.

T!r! ar! n!2!r la+orator% n/tr$m!nt/ a3ala+l! to d!t!rmn! '!mo#lo+nor '!matocrt n +lood donor/ ,'!moc$! +% L!o Da#no/tc/ AB1 '!l/n+or#1

S2!d!n and '!mata/tat +% S!0araton T!cnolo#%1 Inc. ar! !Ham0l!/ of /$c

n/tr$m!nt/. ;$alt% control 0roc!d$r!/ /o$ld +! n accordanc! 2t

man$fact$r!r*/ n/tr$cton/ and t! 5rm*/ SOP.


16/44

A&M P&EPA&ATION

Comm!rcal arm 0r!0araton /$00l!/ ar! 0r!0ar!d +% /!3!ral man$fact$r!r/1

!.#.1 Cln0ad Cor0oraton and Maron Sc!nt5c. T!/! 0rod$ct/ ar! not

mark!d /t!rl! +$t ma% +! $/!d to 0r!0ar! t! donor*/ arm for 0l!+otom%.

Arm 0r!0araton /$00l!/1 /$c a/ #a$!1 cotton +all/1 and a00lcator/ ma%

+! 0r!0ar!d +% t! !/ta+l/m!nt. If t! arm 0r!0araton /$00l!/ ar!

/t!rl!d +% a c!ntral /$00l% 2c / a 0art of a o/0tal*/ o0!raton1 t / not

n!c!//ar% to o+/!r3! t!/! 0r!0araton 0roc!d$r!/ or to r!3!2 t! r!cord/

for t!/! /$00l!/.

Arm 0r!0araton/ /o$ld +! don! 2t car! and for t! f$ll amo$nt of tm! a/

/tat!d n t! SOP1 and d!all% 2t 3#oro$/ /cr$++n#.

T!r! ar! /!3!ral 2a%/ to do a /at/factor% arm 0r!0araton. S$c!nt

d$raton and 3#or of /cr$++n# ar! t! k!% factor/ to r!mo3al of /$0!r5cal

mcro+!/ 2c / t! #oal of t! arm 0r!0araton. T! 5nal /t!0 m$/t +!

a00lcaton of a +act!ro/tatc a#!nt n a non-o3!rla00n# /0ral +!#nnn# at

t! nt!nd!d n!!dl! 0$nct$r! /t! and !Ht!ndn# o$t2ard.

BLOOD COLLECTION

Aft!r t! 3!n0$nct$r! ar!a / 0r!0ar!d1 t! 3!n ma% +! 0al0at!d a+o3! or

+!lo2 t! 0r!0ar!d ar!a o2!3!r t! /t! of n!!dl! n/!rton /o$ld not +!

to$c!d 0ror to 3!n0$nct$r!. It / not 0!rm//+l! to 0$t odn! or /t!rl!

#a$! on t! 5n#!r to 0al0at! t! nt!nd!d 3!n0$nct$r! /t!. N!!dl!/ ma%

+! $/!d for onl% on! 3!n0$nct$r!. If a 3!n0$nct$r! / $n/$cc!//f$l1 a n!2

n!!dl! m$/t +! $/!d and t! arm 0r!0araton r!0!at!d.

T! com0l!ton of t! donaton ma% +! /#nal!d +% a tr0 /cal! or 3ac$$m-

a///t m!tod +a/!d on ma// or 3ol$m!. Ot!r2/!1 t! +a# m$/t +!

2!#!d ,/0rn# /cal!/ and t! o2 /to00!d man$all%. T! +lood /o$ld +!

mH!d #!ntl% ,!t!r man$all% or m!cancall% d$rn# coll!cton. T! 5nal


17/44

$nt /o$ld 2!# a00roHmat!l% #ram/. Lo2 3ol$m!

coll!cton/1 !.#.1 0!datrc a$tolo#o$/ coll!cton/1 ar! acc!0ta+l! 0ro3dn#

t! !/ta+l/m!nt a/ an SOP. For lo2 3ol$m! coll!cton/ to +! /00!d n

nt!r/tat! comm!rc!1 t! faclt% m$/t a3! CBE& a00ro3al.

'!rm!tc /!aln# of t! +lood +a# t$+n# / accom0l/!d +% on! of t!

follo2n#4 d!l!ctrc /!aln#1 m!tal clam01 or t%n# a t#t 2t! knot n t!

donor t$+n#. T! cont!nt/ of t! t$+n# /o$ld +! /tr00!d nto t! +a#1

mH!d 2!ll1 and t! antcoa#$lat!d +lood allo2!d to r!5ll t! t$+n#.

Follo2n# /tr00n# of t! t$+n#1 an addtonal !rm!tc /!al /o$ld +!

0lac!d clo/! to t! +a# /o a/ to 0r!3!nt tam0!rn#1 t!r!+% !n/$rn#

mant!nanc! of a clo/!d /%/t!m.

S0!c5c #ra3t% of 2ol! +lood 7.>@: #mJmL for +lood contann# 78.@

#mJdL of !mo#lo+n. T! follo2n# calc$laton / $/!d to con3!rt 3ol$m! to

2!#t4 7.>@: #mJmL @>> mL @8.@ #m

T!r! ar! 5rm/ 2t a00ro3al from CBE& to coll!ct FFP or ot!r 0la/ma

+%0rod$ct/ $/n# !ma0!r!// d!3c!/. Som! 5rm/ ar! a00ro3!d to al9$ot

t! FFP ,or ot!r 0rod$ct/ nto /mall!r contan!r/ $/n# a /t!rl! t$+n#

conn!ctn# d!3c! ,STCD. An STCD / a d!3c! 2c /!al/ t2o 0!c!/ of

lk! ,/am! /! and com0o/ton t$+n# to#!t!r to mak! a /t!rl!conn!cton. Lc!n/!d !/ta+l/m!nt/ m$/t a3! FDA a00ro3al for

man$fact$rn# com0on!nt/ 2t an SCD. For addtonal #$danc!1 /!! t! ?$l%

81 7< m!morand$m1 U/! of an FDA Cl!ar!d or A00ro3!d St!rl!

Conn!ctn# D!3c! ,STCD n Blood Bank Practc!.

BLOOD COLLECTION CONTAINE&

Nam!/ of +lood contan!r man$fact$r!r/ ma% +! fo$nd on t! la+!l/ of t!

+lood +a#/. T! contan!r/ man$fact$r!d +% C$tt!r La+orator!/ ,D3/on of

Ml!/1 F!n2al La+orator!/ ,BaHt!r '!altcar! Cor0oraton1 and T!r$mo

Cor0oraton a3! +!!n a00ro3!d +% CBE&. A00ro3!d antcoa#$lant/ ncl$d!

antcoa#$lant ctrat! d!Htro/! /ol$ton ,ACD1 antcoa#$lant ctrat!

0o/0at! d!Htro/! /ol$ton ,CPD and CP8D1 and antcoa#$lant ctrat!

0o/0at! d!Htro/! ad!nn! /ol$ton ,CPDA-7.


18/44

Coll!cton /!t/ m$/t +! /tor!d n accordanc! 2t t! man$fact$r!r*/

n/tr$cton/. Ina00ro0rat! /tora#! ma% contr+$t! to !3a0oraton of t!

antcoa#$lantJ0r!/!r3at3! /ol$ton1 or to mold #ro2t on t! contan!r

/$rfac!.

LABO&ATO& SAMPLES

Plot ,la+orator% /am0l!/ contann# +lood for ABO1 &1 ant+od% /cr!!nn#

and 3ral t!/tn# ar! coll!ct!d at t! tm! of donaton. T! t$+!/ m$/t +!

d!nt5!d to acc$rat!l% r!lat! t!m to t! $nt. T! m!tod $/!d for

coll!cton of t! 0lot /am0l! /o$ld +! on! tat 0r!cl$d!/ contamnaton of

t! donor $nt1 mnm!/ 0!r/onn!l !H0o/$r! to +lood1 and mantan/ donor/af!t%. S!! t! AABB T!cncal Man$al1 for m!tod/ of 0lot /am0l! coll!cton.

DATING PE&IOD

EH0raton dat!/ 3ar% from 87 da%/ for ACD1 CPD1 and CP8D1 :@ da%/ for

CPDA-7 n 2ol! +lood and r!d +lood c!ll/1 to and D/0o/ton of Blood

Prod$ct/ Int!nd!d for A$tolo#o$/ U/! tat T!/t &!0!at!dl% &!act3! for Ant-

'C)1 dat!d S!0t!m+!r 771 77.


19/44

T'E&APEUTIC P'LEBOTOM

T!ra0!$tc 0l!+otom!/ ar! con/d!r!d to +! a 0roc!d$r! nt!nd!d to tr!at

t! 0at!nt for c!rtan d/!a/! /tat!/1 t!r!for!1 a 2rtt!n doctor*/ r!9$!/t

/o$ld +! a3ala+l! for t! 0roc!d$r!. Unt/ of +lood tat ar! coll!ct!d for

t!ra0!$tc 0l!+otom% m$/t +! f$ll% t!/t!d and donor/ m!!t all /$ta+lt%

r!9$r!m!nt/ f t! $nt/ ar! to +! tran/f$/!d or f t! 0la/ma 2ll +! /old for

f$rt!r man$fact$r!. S!3!ral r!call/ a3! occ$rr!d d$! to lack of t!/tn# of

r!co3!r!d 0la/ma from t!ra0!$tc $nt/ 0ror to /00n# for f$rt!r

man$fact$r!.

DONO& &EACTIONS

A +lood +ank /o$ld +! a2ar! of t! nat$r! and fr!9$!nc% of donor r!acton/.

Ad!9$at! r!cord/ for !ac r!acton /o$ld +! k!0t and /o$ld ncl$d! follo2-

$0 n ord!r to n/$r! ad!9$at! donor 0rot!cton. T! +lood +ank*/ SOP

man$al /o$ld l/t and d!/cr+! donor r!acton/ t con/d!r/ to +! ad3!r/!1 a/

2!ll a/ t! 0roc!d$r!/ to +! follo2!d for andln# and n3!/t#atn# t!/!

r!acton/. S!3!r! donor r!acton/ ma% ncl$d! fantn#1 con3$l/on/1 /!3!r!

!matoma/ ,n5ltraton1 or n6$r% ca$/!d +% falln#. Mld donor r!acton/

ncl$d! f!!ln# fant1 na$/!at!d1 or d%.

PA&T B - LABO&ATO&

ABO AND &' TESTING1 and &BC Ant+od% Scr!!nn#

Blood Gro$0n# &!a#!nt/ ar! $/!d to d!t!rmn! t! +lood #ro$0. Ant-A 2lla##l$tnat! or cl$m0 #ro$0 A r!d c!ll/. Ant-B 2ll a##l$tnat! #ro$0 B r!d

c!ll/. Ant-D / $/!d to d!t!rmn! &o ,D factor.

Lc!n/!d ant/!ra - /om! !/ta+l/m!nt/ ma% ot!r2/! m!!t t!

r!9$r!m!nt/ for ABO and & lc!n/!d ant+od!/ +% 0rod$cn# t!r o2n

ant/!ra. If /o1 0rod$cton r!cord/ tat ar! n com0lanc! 2t t!


20/44

r!9$r!m!nt/ for t! man$fact$r! of t!/! 0rod$ct/ /0!c5!d n 87 CF& >1

S$+0art C m$/t +! k!0t. Lc!n/!d +lood +ank/ m$/t a3! CBE& a00ro3al to

$/! /$c ant/!ra.

T!/t m!tod/ $/!d for ABO1 & and ant+od% /cr!!nn#1 2c ar! d!r!nt

from t! man$fact$r!r*/ n/tr$cton/1 /o$ld not +! ct!d a/ d!3aton/ f t!%

ar! not 0ro+t!d +% t! man$fact$r!r1 a3! +!!n d!mon/trat!d to +!

/at/factor%1 or a3! +!!n a00ro3!d for $/! +% CBE&. For !Ham0l!1 t!

Mcrott!rTM 0lat!/ and Gro$0amatcTM macn!/ ma% +! $/!d for ABO1 &1

and ant+od% t!/tn#. T! r!a#!nt/ m$/t +! t!/t!d and /o2n to 0!rform

ad!9$at!l% or /at/factorl% 2!n $/n# t!/! t!cn9$!/.

Blood 2c t!/t/ &o,D n!#at3! m$/t +! con5rm!d +% f$rt!r t!/tn#

,$/$all% D$ $nl!// t / la+!l!d n accordanc! 2t 87 CF& .@,c.

Acc!0ta+l! m!tod/ for f$rt!r t!/tn# to con5rm D n!#at3!/ ncl$d! $/! of

t! ant#lo+$ln m!tod1 and $/! of a /0!cal cann!l on t! Kontron

Gro$0amatc1 Ol%m0$/ PK=>>1 or t! Gamma STS-M a$tomat!d +lood

#ro$0!r/. Lc!n/!d +lood !/ta+l/m!nt/ /o$ld a3! a l!tt!r from CBE&

a00ro3n# t!r $/! of an a$tomat!d +lood #ro$0!r for D$ t!/tn#.

Not all ant-D r!a#!nt/ ma% +! $/!d for D$ t!/tn# t! 0acka#! n/!rt m$/t

ncl$d! dr!cton/ for D$ t!/tn#.

Proc!d$r!/ a3! +!!n a00ro3!d to $/! r!a#!nt/ 2t t! Gro$0amatcTM

+!%ond t! datn# 0!rod1 0ro3d!d a 0ro0!r /!t of control/ / $/!d. Lc!n/!d

!/ta+l/m!nt/ /o$ld a3! a l!tt!r from CBE& on 5l! ndcatn# tat a

0rotocol a/ +!!n /$+mtt!d and a00ro3!d for t/ 0roc!d$r!. &ar! r!a#!nt/1

!.#.1 ant-?k+1 ant- L!+1 !tc.1 ar! /om!tm!/ $/!d +!%ond t! !H0raton dat!

t/ / acc!0ta+l! onl% f ad!9$at! control/ ar! $/!d and t! r!act3t% and

/0!c5ct% of t! r!a#!nt/ ar! doc$m!nt!d.

T! r!act3t% and /0!c5ct% of r!a#!nt/ ar! #!n!rall% con5rm!d +% t!/tn#

at l!a/t on! 0o/t3! and on! n!#at3! control /am0l!. T! n!#at3! control/

ar! not !//!ntal for ABO r!a#!nt/ +!ca$/! t! antt!tcal c!ll and /!r$m

r!/$lt/ 0ro3d! con5rmaton of t!/t acc$rac%. T! Ant-'$man Glo+$ln

,Coom+/ r!a#!nt m$/t +! t!/t!d !ac da% of $/! 2t an I#G /!n/t!d

,Coom+/ control or c!ck c!ll.


21/44

T! man$fact$r!r*/ n/tr$cton/ /0!cf% tat t! /tora#! r!9$r!m!nt for Ant-

A1 Ant-B1 and Ant-D r!a#!nt/ / +!t2!!n 8-oC o2!3!r1 t / acc!0t!d

0ractc! for t!/! r!a#!nt/ to /ta% at room t!m0!rat$r! for t! d$raton of

t! 2orkn# da%. T/ 2ll $/$all% not dmn/ t! 0ot!nc% of t! 0rod$ct/tro$#o$t t! normal 0!rod of $/!.

AUTOMATED TESTS FO& ABO Q &' TESTING

&!f!r to t! ?$l% 871 78 CBE& m!morand$m to lc!n/!d !/ta+l/m!nt/ on

Can#!/ n E9$0m!nt for Proc!//n# Blood Donor Sam0l!/. T/ doc$m!nt

0ro3d!/ /0!c5c #$danc! on t! doc$m!ntaton of can#!/ n !9$0m!nt1

/0!c5call% cal+raton1 3aldaton1 0arall!l t!/tn#1 9$alt% control1mant!nanc! and !m!r#!nc% 0lan/.

La+orator% r!cord/ for a$tomat!d t!/tn# /o$ld ncl$d! t! nam! of t!

0!r/on 2o 0r!0ar!d t! r!a#!nt/. If t! /%/t!m do!/ not 0ro3d! 0o/t3!

/am0l! d!nt5caton1 a r!cord m$/t +! mad! for t! loadn# 0att!rn and t!

r!cord m$/t ncl$d! t! nam! of t! 0!r/on,/ 2o load!d and $nload!d t!

/am0l!r f r!/$lt/ ar! 3/$all% nt!r0r!t!d1 t! r!cord m$/t ncl$d! t! nam!

of t! 0!r/on,/ nt!r0r!tn# and tran/f!rrn# t! r!/$lt/.

If t! 5rm $/!d a$tomat!d m!tod/ for ABO and & t%0n# at t! tm! of

lc!n/$r!1 a /!0arat! l!tt!r of a00ro3al from CBE& for a$tomat!d ABO and &

t!/tn# 2ll not +! //$!d to t! !/ta+l/m!nt. &!a#!nt/ $/!d n mcro0lat!

t!/t /%/t!m/ /o$ld +! r!comm!nd!d for t/ $/! +% t! man$fact$r!r*/

0acka#! n/!rt. If not or#nall% lc!n/!d for t! $/! of t! mcro0lat! t!/t

/%/t!m1 a lc!n/!d !/ta+l/m!nt /o$ld a3! on 5l! a l!tt!r from CBE&

a00ro3n# t/ $/!. Gamma-Mcro-U mcrott!r 0lat!/ ar! a00ro3!d for $/! onl%

2t t! Gamma mcrott!r r!a#!nt $nl!// t! r!a#!nt a/ +!!n !3al$at!d

and fo$nd acc!0ta+l! for /$c $/! accordn# to an !/ta+l/!d 0rotocol.

Occa/onall% an a$tomat!d +lood #ro$0n# n/tr$m!nt / $na+l! to nt!r0r!t

an ABO or & r!/$lt. T! 5rm /o$ld a3! an SOP to follo2-$0 2t f$rt!r

t!/tn# to o+tan a r!/$lt ,$/$all% +% man$al m!tod/ and to $0-dat! t!

t!/tn# r!cord ,data !ntr% and 3!r5caton.


22/44

SE&OLOGICAL TEST FO& SP'ILIS

All $nt/ of +lood m$/t +! t!/t!d +% an acc!0ta+l! /!rolo#cal t!/t for /%0l/,STS. For f$rt!r #$danc!1 r!f!r to CBE&*/ D!c!m+!r 781 77

m!morand$m to r!#/t!r!d +lood !/ta+l/m!nt/ on Clar5caton of FDA

&!comm!ndaton/ for Donor D!f!rral Q Prod$ct D/tr+$ton Ba/!d on t!

&!/$lt/ of S%0l/ T!/tn#.

DISEASE MA&KE& TESTING

Eac coll!cton of 2ol! +lood and +lood com0on!nt/ m$/t +! t!/t!d for ant-

'I)1 /%0l/1 and 'B/A#. In addton1 t!% /o$ld +! t!/t!d for ant-'C)1 ant-

'Bc1 and ant-'TL)-I 0!r r!comm!ndaton/ from FDA. T!/tn# for alann!

amnotran/f!ra/! ,ALT 2a/ m0l!m!nt!d a/ a /$rro#at! mark!r for 3ral

!0att/. FDA a/ not mad! an% r!comm!ndaton/ a/ to 2!t!r or not

+lood +ank/ /o$ld 0!rform ALT t!/tn# o2!3!r1 ALT t!/tn# a/ +!com! an

nd$/tr% /tandard. If an !/ta+l/m!nt a/ m0l!m!nt!d ALT t!/tn#1 t!%

/o$ld +! follo2n# t! man$fact$r!r*/ n/tr$cton/ and t!r SOP for

0!rformn# t! t!/t and nt!r0r!tn# t! t!/t r!/$lt/.

Eac $nt of +lood m$/t +! t!/t!d for 'B/A# +% a lc!n/!d trd #!n!raton

t!/t. Trd #!n!raton t!/t/ ncl$d! radomm$noa//a% ,&IA1 r!3!r/! 0a//3!

!ma##l$tnaton ,&P'A1 or !n%m!-lnk!d mm$no/or+!nt a//a% ,ELISA or

EIA.

&!f!r to CBE&*/ D!c!m+!r 881 7:1 m!morand$m to r!#/t!r!d

!/ta+l/m!nt/ !nttl!d Donor S$ta+lt% &!lat!d to La+orator% T!/tn# for

)ral '!0att/ and a '/tor% of )ral '!0att/.

Eac $nt m$/t +! t!/t!d for ant+od% to 'I) 2t a lc!n/!d t!/t kt. T!r!

ar! tr!! t%0!/ of lc!n/!d kt/ +a/!d $0on d!r!nt man$fact$rn#

t!cnolo#!/4


23/44

(ol! 3ral l%/at!/

&!com+nant DNA t!cnolo#% ,S!! t! F!+r$ar% 7 and A$#$/t 71 l1

m!moranda U/! of t! &!com+#!n 'I)-7 LA T!/t for f$rt!r nformaton.

and1

S%nt!tc 0!0td!/.

&!f!r to Com0lanc! Pro#ram =:>71 In/0!cton of Lc!n/! and Unlc!n/!d

Blood Bank/1 Attacm!nt/ C and D1 for a l/t of lc!n/!d t!/t kt/ for 'B/A#1

ant-'I)-71 ant-'I)-81 ant-'I)-7J81 Ant-'C)1 Ant-'+c1 Ant-'TL)-I1 and

(!/t!rn +lot.

TESTING PE&FO&MED ON P&EMISES

&!f!r to t! follo2n# m!moranda for f$rt!r nformaton4

7. &!comm!ndaton/ for t! Mana#!m!nt of Donor/ and Unt/ tat ar!

Intall% &!act3! for '!0att/ B S$rfac! Ant#!n ,'B/A# dat!d D!c!m+!r 81

l=

8. 'TL)-I Ant+od% T!/tn#1 dat!d No3!m+!r 81 7

:. &!3/!d &!comm!ndaton/ for t! Pr!3!nton of 'I) Tran/m//on +%

Blood and Blood Prod$ct/1 dat!d A0rl 8:1 78


24/44

Prod$ct/ from Donor/ 2t Po/t3! T!/t/ for Inf!cto$/ D/!a/! Mark!r/ ,*'#

&/k* Donor/1 dat!d A0rl 7=1 77

. FDA &!comm!ndaton/ Conc!rnn# T!/tn# for Ant+od% to '!0att/ B

Cor! Ant#!n ,Ant-'Bc1 dat!d S!0t!m+!r 7>1 77

=. &!3/!d &!comm!ndaton/ for T!/tn# (ol! Blood1 Blood Com0on!nt/1

So$rc! Pla/ma and So$rc! L!$koc%t!/ for Ant+od% to '!0att/ C )r$/

Encod!d Ant#!n ,Ant-'C)1 dat!d A$#$/t @1 7:

. D/0o/ton of Blood Prod$ct/ Int!nd!d for A$tolo#o$/ U/! Tat T!/t

&!0!at!dl% &!act3! for Ant-'C)1 dat!d S!0t!m+!r 771 77

If a$tomat!d t!/tn# !9$0m!nt / nt!rfac!d 2t a com0$t!r /%/t!m /!!

/!cton on com0$t!raton1 for f$rt!r #$danc!.

In t! 0a/t1 t! ar!a $/!d for 'B/A# and ant-'I) t!/tn# 2o$ld1 +% d!/#n1 +!

n room/ /!0arat!d from ot!r +lood +ank act3t!/. T/ / no lon#!r

con/d!r!d to +! m0ortant a/ all +lood /am0l!/ /o$ld +! tr!at!d a/ ca0a+l!

of tran/mttn# an nf!cto$/ d/!a/!1 and Bo/af!t% L!3!l 8 0r!ca$ton//o$ld +! a00l!d n all ar!a/ 2!r! o0!n /am0l!/ ar! andl!d. 'o2!3!r1 f

&IA 0roc!d$r!/ ar! $/!d n t! faclt% t!/! ar!a/ /tll m$/t +! 0%/call%

/!0arat!d from ot!r ar!a/. (ork ar!a/1 /$c a/ co$nt!r to0/1 /o$ld +!

con/tr$ct!d of non-0oro$/ mat!ral/ and d!/#n!d to 0!rmt toro$#

cl!ann# and d/nf!cton. T!r! /o$ld +! 0olc!/ to 0r!3!nt !Hc!//3! trac

of $na$tor!d 0!r/onn!l tro$# 3ral t!/tn# ar!a/.

P&OFICIENC TESTING

Mo/t +lood !/ta+l/m!nt/ 2ll +! 0artc0atn# n a 0ro5c!nc% t!/tn#

0ro#ram1 !t!r an n-o$/! d!3!lo0!d or an !/ta+l/!d 0ro#ram /$c a/ t!

Coll!#! of Am!rcan Patolo#/t/ ,CAP1 AABB or CDC.


25/44

A 0ro0o/!d r$l! 2a/ 0$+l/!d n t! ?$n! 1 71 F!d!ral &!#/t!r to r!9$r!

tat !ac !/ta+l/m!nt or la+orator% r!/0on/+l! for 0!rformn# FDA

r!9$r!d t!/t/ for 'B/A# and ant- 'I) 0artc0at! n an a00ro3!d 0ro#ram to

d!mon/trat! 0ro5c!nc% n 0!rformn# t!/! t!/t/. T! 5nal r!#$laton

0ro0o/!d +% FDA a/ not +!!n 0$+l/!d1 o2!3!r1 t! 5nal r$l! 0ro0o/!d +%

'CFA1 2c r!#$lat!/ la+orator!/ r!c!3n# M!dcar! and M!dcadr!m+$r/!m!nt1 2a/ 0$+l/!d n t! Marc 71 F!d!ral &!#/t!r. T/

5nal r$l! r!9$r!/ la+orator!/ to a3! 0olc!/ and 0roc!d$r!/ for an on#on#

0ro#ram to a//$r! tat !m0lo%!!/ ar! com0!t!nt and mantan t!r

com0!t!nc% to 0!rform t!r d$t!/.

TESTING PE&FO&MED B OUTSIDE LABO&ATO&IES

T! r!/$lt/ and nt!r0r!taton/ of all ,ntal and r!0!at t!/t/ 0!rform!d and

an !H0lanaton of an% /%m+ol/ or 0ra/!/ $/!d n r!0ortn# r!/$lt/ /o$ld +!

0ro3d!d +% t! t!/tn# faclt% to t! +lood +ank. T! +lood +ank /o$ld a3!

an SOP for t! nt!r0r!taton of t! r!0ort/ o+tan!d from o$t/d! t!/tn#

la+orator!/ and 2rtt!n a//$ranc! tat t! o$t/d! t!/tn# la+orator%

nt!r0r!t/ t!/t r!/$lt/ accordn# to FDA r!9$r!m!nt/. T! ra2 t!/t data1 .!.1

a+/or+anc! r!adn#/ from t! /0!ctro0otom!t!r1 n!!d not +! /!nt to t!

+lood +ank. In addton1 f t! +lood !/ta+l/m!nt / r!-!nt!rn# donor/ 2t

0r!3o$/l% r!0!at!dl% r!act3! ant-'I) t!/t r!/$lt/1 t! !/ta+l/m!nt m$/t

d!t!rmn! f t! o$t/d! t!/tn# la+orator% / 0!rformn# (!/t!rn +lot a//a%/

2t lc!n/!d t!/t kt/.

At t/ tm!1 87 CF& >=.@,# !H!m0t/ from t! r!9$r!m!nt to r!#/t!r

clncal la+orator!/ tat ar! a00ro3!d for M!dcar! r!m+$r/!m!nt

0!rformn# !0att/ and ant-'I) t!/tn# on donor +lood for ot!r r!#/t!r!d

faclt!/. If not r!#/t!r!d1 t! t!/tn# la+orator% /o$ld +! a/k!d to

3ol$ntarl% r!#/t!r. S!nd t! t!/tn# la+orator% Form FDA-8:>1 Blood

E/ta+l/m!nt &!#/traton and Prod$ct L/tn#1 n accordanc! 2t t!

0roc!d$r!/ d!/cr+!d n F!ld Mana#!m!nt Dr!ct3! 8. Lc!n/!d +lood

!/ta+l/m!nt/ ma% a3! 3ral t!/tn# 0!rform!d at t!/tn# faclt!/ 2car! al/o lc!n/!d1 and onl% 2t CBE& a00ro3al.

EHc!0t for !m!r#!nc!/1 no $nt/ /o$ld +! //$!d $ntl 2rtt!n !0att/ and

'I) ant+od% t!/t r!/$lt/ ar! n t! 0o//!//on of t! +lood +ank.


26/44

USE OF &EACTI)E UNITS

&!f!r to t! follo2n# m!moranda4

7. G$d!ln! for Coll!cton of Blood or Blood Prod$ct/ from Donor/ 2t

Po/t3! T!/t/ for Inf!cto$/ D/!a/! Mark!r/ ,'# &/k Donor/1 dat!d

Octo+!r 81 l.

8. &!3/on to 8 Octo+!r 7 G$d!ln! for Coll!cton of Blood or Blood

Prod$ct/ from Donor/ 2t Po/t3! T!/t/ for Inf!cto$/ D/!a/! Mark!r/ ,*'#

&/k* Donor/1 dat!d A0rl 7=1 77.

:. D/0o/ton of Blood Prod$ct/ Int!nd!d for A$tolo#o$/ U/! Tat ar!

&!0!at!dl% &!act3! for Ant-'C)1 dat!d S!0t!m+!r 771 77.

IN)ALIDATION OF TEST &ESULTS

&!f!r to CBE&*/ ?an$ar% :1 7< m!morand$m1 ttl!d &!comm!ndaton/ for

t! In3aldaton of T!/t &!/$lt/ (!n U/n# Lc!n/!d )ral Mark!r A//a%/ to

Scr!!n Donor/.

T!/! r!comm!ndaton/ clarf% FDA*/ 0o/ton on t! n3aldaton of t!/t

r!/$lt/ 2!n /cr!!nn# donor +lood $/n# lc!n/!d 3ral mark!r a//a%/1

ncl$dn# t! $/! of !Ht!rnal control r!a#!nt/.

PA&T C - &ED BLOOD CELLS

OPEN SSTEM

Blood com0on!nt/ for tran/f$/on ar! normall% 0r!0ar!d n a clo/!d1 /t!rl!


27/44

/%/t!m. Occa/onall%1 o2!3!r1 t! !rm!tc /!al ma% +! +rok!n1 t!r!+%

!H0o/n# t! +lood com0on!nt to t! o$t/d! !n3ronm!nt. (!n t/ occ$r/

t! com0on!nt /o$ld a3! an !H0raton dat! not to !Hc!!d 8< o$r/.

ADDITI)E SOLUTIONS

Man$fact$r!r/ of c!rtan +lood coll!cton /%/t!m/ a3! +!!n a00ro3!d for a

room t!m0!rat$r! !#t o$r old 0!rod follo2n# t! coll!cton of 2ol!

+lood 0ror to 0r!0araton of com0on!nt/. T!/! /%/t!m/ ar! t! ADSOL&

/ol$ton /%/t!m ,antcoa#$lant CPD1 man$fact$r!d +% F!n2al La+orator!/1

D3/on of BaHt!r '!altcar! Cor0oraton1 t! N$trc!l& /%/t!m

,antcoa#$lant CP8D1 man$fact$r!d +% C$tt!r Bolo#cal1 D3/on of Ml!/

Inc.1 and O0t/ol&1 man$fact$r!d +% T!r$mo Cor0oraton. In addton1 F!n2al*/

coll!cton /%/t!m contann# CPDA-7 / al/o a00ro3!d for an !#t o$r old

0ror to com0on!nt 0r!0araton. Plat!l!t/1 Fr!/ Fro!n Pla/ma1

Cr%o0r!c0tat!d A'F and &!co3!r!d Pla/ma ma% +! 0r!0ar!d from t! 2ol!

+lood 2tn !#t o$r/ of coll!cton.

If Fr!/ Fro!n Pla/ma1 Plat!l!t/1 or Cr%o0r!c0tat!d A'F ar! not 0r!0ar!d

from t! $nt/ of 2ol! +lood1 t! addt3! /ol$ton ma% +! add!d to t! r!d

+lood c!ll/ ,&BC*/ 2tn tr!! da%/ of coll!cton.

&ED BLOOD CELLS F&OREN AND &ED BLOOD CELLS DEGLCE&OLIRED

T! fr!!n# of &BC*/ ma% +! accom0l/!d +% t2o acc!0ta+l! t!cn9$!/1

!.#.1 # conc!ntraton #l%c!rol-/lo2 fr!!! ,/tora#! at -@oC and lo2

conc!ntraton #l%c!rol-ra0d fr!!! ,/tora#!1 $/$all% n l9$d N81 at

-78>oC. T! lot n$m+!r/ of /ol$ton/ and contan!r/ for #l%c!rolaton and

d!#l%c!rolaton m$/t +! r!cord!d. &!d Blood C!ll/1 Fro!n ma% +! /tor!d for

t!n %!ar/. If $nt/ n /tora#! a3! not +!!n t!/t!d for all c$rr!ntl% r!9$r!d

t!/t/1 t!r! /o$ld +! a 0roc!d$r! to 0r!3!nt m/la+!ln# 2!n $nt/ ar!

ta2!d.

;$alt% control t!/tn# /o$ld +! 0!rform!d and t! 5rm /o$ld tak!

corr!ct3! acton 2!n t!/t r!/$lt/ ar! o$t of t! 5rm*/ !/ta+l/!d

0aram!t!r/ a/ /tat!d n t! SOP*/. ;$alt% control t!/tn# ma% ncl$d!


28/44


29/44

For $nt/ la+!l!d L!$koc%t!/ &!mo3!d 9$alt% control ,;C /o$ld +!

0!rform!d for all t! m!tod/ l/t!d a+o3!. T/ montl% ;C / not n!c!//ar%

f4 ,7 t! $nt / not la+!l!d L!$koc%t!/ &!mo3!d or ,8 t! l!$koc%t!/ ar!

r!mo3!d a/ t! $nt / +!n# tran/f$/!d $/n# a 5lt!r tat / conn!ct!d to t!tran/f$/on /!t +% t! man$fact$r!r or at t! 0at!nt*/ +!d/d!. T! +lood

+ank /o$ld a3! SOP*/ /tatn# 3al$!/ of acc!0tanc! for l!$koc%t! r!mo3al

and corr!ct3! acton to +! tak!n f 3al$!/ ar! o$t/d! !/ta+l/!d lmt/.

Flt!r/ /0!c5c for l!$koc%t! r!mo3al ar! /om!tm!/ conn!ct!d to t!

tran/f$/on /!t at t! 0at!nt*/ +!d/d! and t 2o$ld not +! 0ractcal to

montor t! 0o/t- 5ltraton +lood for l!$koc%t! co$nt/. T! 9$alt% control for

t!/! 5lt!r/ 2a/ 0!rform!d +% t! man$fact$r!r a/ 0art of t! a00ro3al

0roc!//. Tran/f$/on /!r3c!/ tat $/! 5lt!r/ tat r!mo3! l!$koc%t!/ d$rn#

tran/f$/on ar! not con/d!r!d to +! man$fact$rn# a +lood 0rod$ct.

I&&ADIATED BLOOD

EH0!rm!ntal data a3! !/ta+l/!d tat n c!rtan mm$nod!0r!//!d

0at!nt/ tran/f$/on of for!#n mm$nocom0!t!nt c!ll/ ,T l%m0oc%t!/ ma%

l!ad to #raft 3!r/$/ o/t d/!a/! ,G)'D. G)'D occ$r/ 2!n donor T

l%m0oc%t!/ !n#raft1 m$lt0l% and r!act a#an/t t! t//$!/ of t! r!c0!nt.

T! rado/!n/t3t% of t!/! T l%m0oc%t!/ / #!r tan tat of ot!r +lood

c!ll/1 /o rradaton of c!ll$lar +lood 0rod$ct/ +!for! rran/f$/on a00!ar/ to +!

!!ct3! n 0r!3!ntn# t! tran/f$/on nd$c!d form of t/ /!ro$/

com0lcaton. T! AABB a/ r!c!ntl% r!comm!nd!d tat +lood com0on!nt/

0r!0ar!d from dr!ct!d +lood donaton/ from 5r/t d!#r!! faml% m!m+!r/

,.!.1 0ar!nt/1 cldr!n1 /+ln#/ +! rradat!d to d!cr!a/! t! r/k of G)'D.

T! CBE& //$!d #$danc! 3a a ?$l% =1 7:1 m!morand$m ttl!d

&!comm!ndaton/ &!#ardn# Lc!n/! Am!ndm!nt/ and Proc!d$r!/ for

Gamma Irradaton of Blood Prod$ct/. T/ doc$m!nt addr!//!/

man$fact$rn# and 9$alt% a//$ranc! 0roc!d$r!/1 la+!ln#1 ot!r a/0!ct/ of

0rod$cton and t! $/! of rradat!d +lood and +lood 0rod$ct/. It al/o

0ro3d!/ +ack#ro$nd on t! !!ct/ of #amma radaton on 0rod$ct 9$alt% Q

/ta+lt%1 #$danc! on lc!n/! am!ndm!nt/1 r!cord k!!0n# and fatalt%r!0ortn#. If an% 9$!/tona+l! 0roc!d$r!/ for rradatn# +lood ar!

!nco$nt!r!d d$rn# an n/0!cton notf% t! D3/on of In/0!cton/ and

S$r3!llanc!1 ,:>7 @


30/44

Blood +ank/ tat 0r!0ar! 2a/!d1 fro!n1 d!#l%c!rol!d and r!6$3!nat!d

&BC*/ m$/t r!cord t! lot n$m+!r/ of /ol$ton/ andJor contan!r/. T! lot

n$m+!r/ m$/t +! trac!a+l! to t! $nt n$m+!r.

&ED BLOOD CELLS - IMMUNIRATION P&OG&AMS

&!f!r to CBE&*/ D!c!m+!r 71 78 m!morand$m on t! &!3/on of

Octo+!r =1 71 M!morand$m Conc!rnn# &!d Blood C!ll Imm$naton

Pro#ram/. T/ doc$m!nt ncor0orat!/ a 78 mont d!f!rral for donor/ and

r!c0!nt/ of &BC/ for mm$naton a/ 0art of So$rc! Pla/ma 0ro#ram/. It

al/o 0ro3d!/ addtonal nformaton on fro!n /tora#!1 /!l!cton of /af!

donor/ and lc!n/! am!ndm!nt/.

PA&T D - PLASMA AND &ECO)E&ED PLASMA

Eac 5nal contan!r of 0la/ma for tran/f$/on 0r!0ar!d from a 2ol! +lood

coll!cton /all +! n an nt!#rall% attac!d /at!llt! +a# at t! tm! of

coll!cton t m$/t +! tran/0ar!nt and !rm!tcall% /!al!d +% a d!l!ctrc

/!al!r1 m!tal clam01 or t#tl% dra2n 2t! knot and t/ la+!l m$/t +!

mark!d +% n$m+!r or ot!r /%m+ol /o tat t can +! trac!d +ack to t! donor.

PLASMA P&ODUCTS FO& T&ANSFUSION

T! 5nal 0rod$ct /o$ld +! /tor!d n a mann!r 2c 2ll /o2 !3d!nc! of

ta2n#. T/ ma% +! accom0l/!d n a 3ar!t% of 2a%/1 !.#.1 +% /torn# t

$0/d! do2n aft!r fr!!n#1 or +% 0lacn# a r$++!r +and aro$nd t! mddl! of

t! contan!r and r!mo3n# t 2!n t! $nt a/ fro!n.

&ECO)E&ED PLASMA

&!co3!r!d Pla/ma / an $nlc!n/!d /o$rc! mat!ral nt!nd!d for $/! n t!


31/44

man$fact$r! of +ot lc!n/!d and $nlc!n/!d 0rod$ct/. A lc!n/! / not

r!9$r!d to man$fact$r!1 d/tr+$t!1 or 0ool r!co3!r!d 0la/ma.

T! /ort /$00l% 0ro3/on allo2/ lc!n/!d man$fact$r!r/ to $/! $nlc!n/!d or

ot!r lc!n/!d faclt!/1 not a 0art of t!r o2n !/ta+l/m!nt1 to 0!rform t!

ntal and 0artal man$fact$rn# /t!0 of coll!ctn# +lood or 0la/ma. T!

&!co3!r!d Pla/ma / /00!d /ol!l% to t! lc!n/!! for f$rt!r man$fact$r!

nto lc!n/!d n6!cta+l! or nonn6!cta+l! 0rod$ct/. Sort /$00l% a#r!!m!nt/

ar! +!t2!!n t! lc!n/!d fractonator and t! coll!cton faclt% not 2t

+rok!r/. T! 2rtt!n a#r!!m!nt/ /o$ld +! $0- dat!d 0!rodcall%1 and a co0%

of t/ a#r!!m!nt /o$ld +! on 5l! at t! coll!ctn# faclt%. Pla/ma +rok!r/

ma% +! $/!d a/ a$tor!d a#!nt/ and /o$ld +! d!nt5!d n t! /ort

/$00l% a#r!!m!nt r!f!r t! nam! of t! +rok!r takn# 0o//!//on of t!

&!co3!r!d Pla/ma or ot!r +lood com0on!nt/ to t! om! d/trct for follo2-

$01 .!.1 r!#/traton and n/0!cton. Sort /$00l% a#r!!m!nt/ ar! al/or!9$r!d +!t2!!n t! r!#/t!r!d coll!cton faclt% and t! lc!n/!d

man$fact$r!r for ot!r +lood com0on!nt/ ,.!.1 &BC*/ and 0lat!l!t/ nt!nd!d

for f$rt!r man$fact$r! nto lc!n/!d 0rod$ct/.

&!co3!r!d Pla/ma do!/ not a3! an !H0raton dat!1 t!r!for!1 r!cord/ ar! to

+! k!0t nd!5nt!l%.

PA&T E - PLATELETS

D$! to an ncr!a/! n t! n$m+!r of 0o/t-tran/f$/on /!0// r!0ort/1 t!

/!3!n da% datn# 0!rod for 0lat!l!t/ r!3!rt!d to 53! da%/1 !!ct3! ?$l% 81

7.

Plat!l!t/ ma% +! 0ool!d +% t! +lood +ank 0!r/onn!l1 $0on t! r!9$!/t of a

0%/can o2!3!r1 t/ / don! follo2n# d!/#naton of t! 0lat!l!t/ to a

/0!c5c r!c0!nt1 and t! r!/$ltant 0ool / not con/d!r!d a lc!n/!d 0rod$ct.

T! la+!l of t! 0ool!d com0on!nt/ /o$ld ndcat! t! nd3d$al donor

n$m+!r/ com0r/n# t! 0ool or a 0ool n$m+!r tat r!lat!/ t to nd3d$al

donor n$m+!r/ com0r/n# t! 0ool. Fnal contan!r/ m$/t +! tran/0ar!nt and

!rm!tcall% /!al!d +% a d!l!ctrc /!al!r1 m!tal clam01 or t#tl% dra2n

2t! knot. T! !H0raton tm! for 0ool!d 0lat!l!t/ / lmt!d to < o$r/.

Untl data ar! a3ala+l! ndcatn# t! !!ct3!n!// of t! 0lat!l!t/ /


32/44

mantan!d for a lon#!r 0!rod of tm! and CBE& a00ro3al / o+tan!d1 t!

!H0raton tm! of Plat!l!t/ 2c ar! 0ool!d 2t t! ad of a /t!rl!

conn!ctn# d!3c! / al/o lmt!d to fo$r o$r/.

;UALIT CONT&OL

;$alt% control t!/tn# m$/t +! 0!rform!d !ac mont 0lat!l!t/ ar! 0r!0ar!d1

$/n# on! $nt o+tan!d from !ac of fo$r d!r!nt donor/. Plat!l!t co$nt/

,@.@ H 7>7> n =@ of t! $nt/ t!/t!d1 P d!t!rmnaton , .> and

m!a/$r!m!nt of 0la/ma 3ol$m! /o$ld +! mad! at t! !nd of t!

/tora#!Jdatn# 0!rod.

If 9$alt% control t!/tn# / not $nd!r t! /$0!r3/on and control of t!

!/ta+l/m!nt1 d!t!rmn! 2!r! t! t!/tn# / 0!rform!d and o2 t!/t r!/$lt/

ar! r!3!2!d and andl!d +% t! !/ta+l/m!nt.

PA&T F - C&OP&ECIPITATED A'F ,ANTI'EMOP'ILIC FACTO&

T!r! / no 3ol$m! r!/trcton for 0r!0arn# Cr%o0r!c0tat!d A'F. On! $nt of

0la/ma ma% +! $/!d a/ a /o$rc! of +ot Plat!l!t/ and Cr%o0r!c0tat!d A'F.Practcal !H0!r!nc! a/ d!mon/trat!d tat $/n# car!f$l 0rod$cton

t!cn9$!/1 an acc!0ta+l! 5nal 0rod$ct a3!ra#n# no l!// tan > IU can +!

man$fact$r!d from a /n#l! $nt.

A/ 2t Plat!l!t/1 Cr%o0r!c0tat!d A'F ma% +! 0ool!d $0on r!9$!/t of a

0%/can. T! la+!l of 0ool!d com0on!nt/ /o$ld ndcat! t! nd3d$al

donor n$m+!r/ com0r/n# t! 0ool or a 0ool n$m+!r tat r!lat!/ t! 0ool!d

A'F to t! nd3d$al donor n$m+!r/ com0r/n# t! 0ool. T!r! ar! /om!

5rm/ man$fact$rn# Cr%o0r!c0tat!d A'F1 Pool!d a/ a lc!n/!d 0rod$ct.

Frm/ ma% a3! a00ro3al for 3aranc!/ $nd!r 87 CF& .78> from t!

r!#$laton/ for man$fact$rn# Cr%o0r!c0tat!d A'F1 .!.1 0r!0arn#

Cr%o0r!c0tat!d A'F 2tn 7@ o$r/ aft!r 0l!+otom%. T! 5rm /o$ld a3!

2rtt!n a00ro3al from CBE& for an% 3aranc!.


33/44

T! 5nal contan!r /o$ld +! tran/0ar!nt and !rm!tcall% /!al!d +% a

d!l!ctrc /!al!r1 m!tal clam01 or a t#t 2t! knot.

;UALIT CONT&OL

;$alt% control t!/tn# n!!d +! 0!rform!d onl% n t! mont/ n 2c t!

0rod$ct / 0r!0ar!d. Fo$r $nt/ m$/t +! t!/t!d1 +$t t!% ma% +! 0ool!d

+!for! t! 9$alt% control a//a% / 0!rform!d.

If 9$alt% control t!/tn# / not 0!rform!d $nd!r t! /$0!r3/on of t!

!/ta+l/m!nt1 /!! Com0lanc! Polc% G$d! =7:1 7@1 and t! !!ct3! dat! 2a/S!0t!m+!r 81 7. A r!3/!d G$d!ln! for Unform Blood La+!ln# /

!H0!ct!d to +! 0$+l/!d n t! n!ar f$t$r!. S0!c5c la+!l nformaton /o$ld

d!0ct r!f!r!nc! to 3ral mark!r t!/tn# r!/$lt/ and ot!r t!/t/ 0!rform!d1

!.#. ALT.

CI&CULA&S

T! crc$lar/ ar! of #r!at m0ortanc! no2 tat $nform or commonalt% la+!l/ar! n $/!. T! n!2 la+!l/ a3! l!// nformaton on t!m /o tat att!nton

2ll +! foc$/!d on t! +lood #ro$0 ,ABO and &. Informaton tat a/ +!!n

d!l!t!d m$/t +! n t! crc$lar. T! crc$lar of nformaton / an !Ht!n/on of

t! contan!r la+!l/ and 3!2!d a/ la+!ln# contann# /tat!m!nt/ of

0$r0ort!d 0rod$ct 9$alt%. It /o$ld d!/cr+! !ac com0on!nt a3ala+l! for

0at!nt tran/f$/on and #3! ndcaton/ and contrandcaton/ for $/!. T!

+lood /$00l!r /o$ld a3! a 0lan for d/tr+$tn# t! n/tr$cton crc$lar/1


34/44

a//$rn# tat t! tran/f$/on /!r3c!/ a3! an ad!9$at! /$00l% of t!

crc$lar/1 and t! tran/f$/on /!r3c! /o$ld a3! a 0lan for d/tr+$tn# t!

crc$lar/ to t! /ta. Lc!n/!d +lood +ank/ 2ll a3! /$+mtt!d t!r crc$lar/

to CBE& for a00ro3al. T! 5rm*/ nam! and addr!// /o$ld +! on t! crc$lar.

PA&T ' - COMPATIBILIT TESTING AND T&ANSFUSION &EACTIONS

COMPATIBILIT TESTING

Com0at+lt% t!/tn# /o$ld +! 0!rform!d n an ar!a /$c!ntl% r!mo3!d

from ot!r ar!a/ to !lmnat! d/tracton or t! ntrod$cton of !rror/ n

t!/tn#.

'o/0tal/ ma% !l!ct not to cro//matc +lood for c!rtan /$r#cal 0roc!d$r!/

tat $/$all% do not r!9$r! t! tran/f$/on of +lood. T/ 0roc!d$r! / r!f!rr!d

to a/ t%0! and /cr!!n and r!9$r!/4 7 d!t!rmnaton of t! 0at!nt*/ +lood

#ro$0 8 t!/t/ of 0at!nt*/ /!r$m for $n!H0!ct!d ant+od!/ and :

a3ala+lt% of $nt/ of +lood n ca/! t! 0at!nt do!/ n!!d +lood d$rn# t!

o0!raton.

S!! t! D!c!m+!r 7


35/44

0!rform!d on a $nt +% t! /$00l!r1 t! o/0tal or tran/f$/on /!r3c! n!!d

not r!0!at t1 or 0!rform a mnor cro//matc.

&ECIPIENT SAMPLE IDENTIFICATION

T! r!c0!nt*/ +lood /am0l! /o$ld +! d!nt5!d +% nam! and n$m+!r to

n/$r! 0o/t3! d!nt5caton. Donor and r!c0!nt +lood /am0l!/ /o$ld +!

/a3!d for at l!a/t /!3!n da%/ aft!r tran/f$/on n ca/! t!r! / a n!!d for

r!t!/tn#.

EME&GENC T&ANSFUSIONS

SOP*/ /o$ld +! a3ala+l! to !H0!dt! t!/tn# for tran/f$/on/ n a lf!

tr!at!nn# !m!r#!nc%. Doc$m!ntaton /o$ld ncl$d! /#nat$r! of t!

r!9$!/tn# 0%/can. If cro//matc!/ ar! not com0l!t!d /$c!nt

doc$m!ntaton /o$ld +! a3ala+l!.

COMPATIBILIT TEST &ECO&DS

&!cord/ /o$ld +! k!0t of r!c!0t of r!c0!nt*/ /am0l! and t! ABO and &

t!/t r!/$lt/ lot n$m+!r/ of r!a#!nt/ $/!d for t!/tn# and ro$tn! and

!m!r#!nc% cro//matc!/ and dr!ct ant#lo+$ln t!/tn# ,f don!. T! 3tal

/#n/ of a r!c0!nt ar! not r!9$r!d to +! on 5l! at t! +lood +ank.

&ECIPIENT AD)E&SE &EACTIONS

T! +lood +ank*/ SOP man$al /o$ld l/t and d!/cr+! r!c0!nt r!acton/ t

con/d!r/ to +! ad3!r/!1 a/ 2!ll a/ t! 0roc!d$r!/ to +! follo2!d for andln#

and n3!/t#atn# t!/! r!acton/. &!c0!nt r!acton/ $/$all% not con/d!r!d

/!ro$/ ncl$d! lo2 f!3!r and cll/ of /ort d$raton1 3!/1 or $rtcara.

S!ro$/ ad3!r/! r!c0!nt r!acton/ $/$all% ncl$d! !mol%//1 +act!r!ma1 or

/!0tc!ma.


36/44

If t! +lood +ank act/ a/ a tran/f$/on /!r3c! and r!c!3!/ +lood from ot!r

/o$rc!/1 !rror/ n t! ABO and & #ro$0n# /o$ld +! r!0ort!d to t!

/$00l!r/. Proc!d$r!/ /o$ld +! !/ta+l/!d +!t2!!n t! /$00l!r/ and $/!r/

of +lood and +lood 0rod$ct/ for montorn# r!c0!nt ad3!r/! r!acton/ 2cocc$r o$t/d! t! /$00l%n# faclt%. If t! /$00l!r of m/t%0!d +lood / a

lc!n/!d !/ta+l/m!nt1 t / t! r!/0on/+lt% of tat !/ta+l/m!nt to r!0ort

an% !rror/ to CBE&1 Oc! of Com0lanc!. &!f!r to CBE&*/ m!morand$m to

nd$/tr% dat!d Marc 8>1 771 ttl!d &!/0on/+lt!/ of Blood

E/ta+l/m!nt/ &!lat!d to Error/ Q Accd!nt/ n t! Man$fact$r! of Blood

Com0on!nt/.

PA&T I - STO&AGE1 DIST&IBUTION

P'SICAL STO&AGE

Blood 0rod$ct/ /o$ld +! /tor!d /!0arat!l% +$t not n!c!//arl% n a d!r!nt

r!fr#!rator.

;$arantn! 0roc!d$r!/ ar! a 3!r% m0ortant ar!a n t! control 0roc!d$r!/ to

0r!3!nt t! d/tr+$ton of $n/$ta+l! $nt/. S!0arat! /tora#! ar!a/ /o$ld +!

mantan!d for $nt!/t!d $nt/1 for $nt/ 2c ar! not /$ta+l! for $/! ,$nt/

to +! r!t!/t!d or r!0!at!dl% r!act3!1 and for $nt/ 2c ar! /$ta+l! for

d/tr+$ton.

Unt/ of +lood nt!nd!d for a$tolo#o$/ $/! /o$ld +! /tor!d n an ar!a

/!0arat! from $nt/ for allo#!n!c $/!.

STO&AGE TEMPE&ATU&E AND &ECO&DS

All r!9$r!d t!m0!rat$r!/ /o$ld +! mantan!d. Fl$ct$aton/ o$t/d! /tora#!

t!m0!rat$r! lmt/ m$/t +! doc$m!nt!d a/ to t! 0o//+l! r!a/on1 and an%

acton r!9$r!d to mantan t! +lood or com0on!nt/ at t! 0ro0!r /tora#!

t!m0!rat$r! m$/t al/o +! doc$m!nt!d.


37/44

T! 0rod$ct /tora#! t!m0!rat$r! aft!r dra2n# / 7-oC $nl!// room

t!m0!rat$r! 0lat!l!t/ ar! to +! 0r!0ar!d1 n 2c ca/! t! +lood /o$ld +!

!ld at 8>-8oC ,oF

and a+o3! 8oC.

INSPECTION

Blood /o$ld +! 3/$all% n/0!ct!d at t! tm! of //$! for an% a+normalt%1/$c a/ !mo#lo+n n t! 0la/ma from r!d c!ll l%//1 0$r0l! tn#!d r!d c!ll/

d$! to +act!ral contamnaton1 or +lood clot/.

S'IPPING

Faclt!/ /o$ld a3! 0roc!d$r!/ to /o2 tat /00n# contan!r/ mantan

0rod$ct/ at t!r a00ro0rat! t!m0!rat$r!.

&EISSUE

Blood +ank/ /o$ld a3! 2rtt!n crt!ra for r!//$n# +lood tat / r!t$rn!d

to t! +lood +ank. St$d!/ a3! /o2n tat t! $nt of +lood /ttn# at room

t!m0!rat$r! $/$all% mantan/ a t!m0!rat$r! of 7>oC for :> mn$t!/. Blood

tat a/ +!!n //$!d for tran/f$/on ma% +! r!//$!d f t / r!t$rn!d to t!

+lood +ank 2tn :> mn$t!/1 and 2a/ k!0t at room t!m0!rat$r! or cold!r2l! o$t of t! +lood +ank*/ control.

PA&T ? - PLATELETS1 P'E&ESIS


38/44

&!f!r to t! Octo+!r1 l1 m!morand$m from CBE& to all r!#/t!r!d +lood

!/ta+l/m!nt/ &!3/!d G$d!ln! for t! Coll!cton of Plat!l!t/1 P!r!//.

PA&T K - COMPUTE&IRATION

T/ /!cton 2ll +! $/!d to !3al$at! USE&S of com0$t!r /%/t!m/1 and t /

not nt!nd!d for $/! n t! n/0!cton of /oft2ar! d!3!lo0!r/.

&!f!r to t! FDA Draft G$d!ln! for t! )aldaton of Blood E/ta+l/m!nt

Com0$t!r S%/t!m/. T/ doc$m!nt foc$/!/ on com0$t!r /%/t!m d!5nton/1

t!/tn#1 man$al/1 mant!nanc!1 /!c$rt%1 trann#1 a$dt/1 FDA r!f!r!nc!/ and

r!0orta+l! act3t!/ to t! FDA. T! 5nal doc$m!nt 2ll /$0!r/!d! t! A0rl1 71 m!morand$m from CBE& to all r!#/t!r!d +lood !/ta+l/m!nt/

&!comm!ndaton/ for Im0l!m!ntaton of Com0$t!raton n Blood

E/ta+l/m!nt/1 and t! S!0t!m+!r 1 l1 m!morand$m &!9$r!m!nt/

for Com0$t!raton of Blood E/ta+l/m!nt/.

T! draft #$d!ln! /o$ld +! $/!d a/ t! man #$danc! doc$m!nt on

com0$t!r!d /%/t!m/ for r!#/t!r!d +lood !/ta+l/m!nt/. 'o2!3!r1 t!

doc$m!nt / /$+6!ct to can#!1 a/ 0$+lc comm!nt/ ar! +!n# coll!ct!d and

!3al$at!d for ncor0oraton nto t! 5nal #$d!ln!. S0!c5c r!#$laton/ 2car! c$rr!ntl% a00lca+l! ar! 87 CF& >.> ,E9$0m!nt1 and 87 CF& 877.

,A$tomatc1 m!cancal1 and !l!ctrcal !9$0m!nt for addtonal nformaton.

If a +lood !/ta+l/m!nt / d!3!lo0n# and d/tr+$tn# /oft2ar! tat 2a/

or#nall% nt!nd!d for n-o$/! $/!1 r!0ort t! n$m+!r and d!ntt% of t!

$/!r /t!/. Blood !/ta+l/m!nt/ d!3!lo0n# and d/tr+$tn# /oft2ar! for $/!

n man$fact$rn# +lood and +lood com0on!nt/ /o$ld +! ad3/!d tat t!%

ar! a d!3c! man$fact$r!r and +! !nco$ra#!d to r!#/t!r and l/t 2t t!

C!nt!r for D!3c!/ and &adolo#cal '!alt.

If t! /oft2ar! / 3!ndor /$00l!d1 d!ntf% t! d!3!lo0!r and 3!r/on.

Soft2ar! d!3!lo0!r/ t%0call% /0!cf% t! /oft2ar! +% a 3!r/on n$m+!r.

(!n ma6or can#!/ a3! occ$rr!d n t! /oft2ar!1 a n!2 n$m+!r /

a//#n!d. If a 3!r/on d!r!nt from t! or#nal / n $/!1 t! faclt% /o$ld

a3! 0roc!d$r!/ to t!/t t! /oft2ar! 0ror to m0l!m!ntaton and


39/44

doc$m!ntaton tat t! t!/tn# 2a/ 0!rform!d.

A /ar!d com0$t!r /%/t!m / a /%/t!m $/!d +% +ot t! +lood +ank and

ot!r /!cton/ of a clncal la+orator% or t! !ntr! o/0tal. S!c$rt%

0roc!d$r!/ /o$ld a3! +!!n !/ta+l/!d r!#ardn# lmtn# acc!// to

con5d!ntal +lood +ank nformaton1 !.#.1 donor d!f!rral r!cord/. In addton1

acc!// to +lood +ank data /o$ld +! lmt!d /o tat nad3!rt!nt or

$na$tor!d can#!/ n data do not occ$r.

(!n a d!c/on / mad! r!#ardn# donor /$ta+lt% andJor 0rod$ct 9$alt%

+a/!d $0on t! $/! of and r!lanc! on t! data mantan!d n t! com0$t!r

/%/t!m1 t! com0$t!r /%/t!m / 0!rformn# a crtcal f$ncton n t!

man$fact$r! of +lood and +lood 0rod$ct/. An n3!/t#ator /o$ld d!t!rmn!

o2 t! com0$t!r /%/t!m / $/!d and r!l!d $0on n crtcal man$fact$rn#

/t!0/ +!#nnn# 2t t! donaton and contn$n# tro$# 0rod$ct r!l!a/!.

A /ort d!/cr0ton 2t r!/0!ct to !ac of t! ar!a/ controll!d +% t!

com0$t!r /o$ld +! r!0ort!d1 !.#.1 t! 5rm d!0!nd/ on t! com0$t!r to

c!ck for 0!rman!nt and t!m0orar% d!f!rral/ $0dat!/ for t! d!f!rral l/t

ar! mantan!d dr!ctl% +% t! com0$t!r 2c !3al$at!/ all t!/t r!/$lt/

r!c!3!d dr!ctl% from t! t!/t !9$0m!nt all com0on!nt 0roc!//n# /

0!rform!d $/n# +ar cod!d la+!l/ 9$arantn! / com0$t!r controll!d and f

r!act3! t!/t r!/$lt/ ar! not!d1 an a$tomatc a# / 0$t on t! $nt +% t!com0$t!r /o tat t! $nt ,com0on!nt/ ncl$d!d cannot +! r!l!a/!d for

d/tr+$ton.

TE&MS AND ABB&E)IATIONS

Allo#!n!c Donor - A donor 2o donat!/ a $nt of +lood to +! 0lac!d n t!

#!n!ral +lood /$00l%. T/ donor m$/t m!!t all /$ta+lt% r!9$r!m!nt/ and

+! f$ll% t!/t!d.

Ant-A1 Ant-B Blood Gro$0n# &!a#!nt - &!a#!nt/ $/!d to d!t!rmn! +lood

#ro$04 Ant-A /!r$m1 from a #ro$0 B nd3d$al1 2ll a##l$tnat! or cl$m0

#ro$0 A r!d c!ll/ Ant-B /!r$m1 from a #ro$0 A nd3d$al1 2ll a##l$tnat! or

cl$m0 #ro$0 B r!d c!ll/.


40/44

Ant-D Blood Gro$0n# &!a#!nt - &!a#!nt $/!d to d!t!rmn! &o,D factor.

S!r$m from an & n!#at3! nd3d$al 2o a/ +!!n !H0o/!d to t! D

ant#!n +% tran/f$/on or 0r!#nanc% and a/ form!d t! ant+od% to t! D

ant#!n1 or monoclonal ant+od!/ 2c ar! 0r!0ar!d +% %+rdomat!cn9$!/.

Ant+od% Scr!!n - Donor or 0at!nt /!r$m / t!/t!d 2t r!a#!nt r!d c!ll/ of

kno2n ant#!nc mak!$0 t! 0$r0o/! / to d!t!rmn! f t! donor or 0at!nt

a/ ant+od!/ n / or !r /!r$m.

A$tolo#o$/ Donor - A donor 2o donat!/ a $nt of +lood ,0r!d!0o/t for

/J!r o2n $/!.

Bo/af!t% L!3!l 8 - C!nt!r/ for D/!a/! Control and Natonal In/tt$t!/ of

'!alt1 D!0artm!nt of '!alt and '$man S!r3c!/1 0$+l/!d a +ookl!t

!nttl!d Bo/af!t% n Mcro+olo#cal and Bom!dcal La+orator!/ 2c

r!comm!nd/ 0r!ca$ton/ 2c la+orator% !m0lo%!!/ /o$ld follo2. T!

+ookl!t / a3ala+l! tro$# D''S 0$+lcaton No. ,CDC -:@1 7 8@-77. In addton1 t! AABB T!cncal Man$al /$mmar!/Bo/af!t% L!3!l 8 0r!ca$ton/.

Cr%o0r!c0tat!d A'F ,Ant!mo0lc Factor - t! cold-n/ol$+l! 0orton of

0la/ma r!mann# aft!r FFP a/ +!!n ta2!d +!t2!!n 7o and oC.

Cr%o0r!c0tat!d A'F ,Cr%o / $/!d to tr!at 0at!nt/ 2t !mo0la A1 3on

(ll+rand*/ d/!a/! and %0o5+rno#!n!ma. Cr%o contan/ 5+rno#!n and

Factor )III1 a 0rocoa#$lant 0r!/!nt n normal 0la/ma +$t d!5c!nt n t!

0la/ma of 0at!nt/ 2t !mo0la A.

Dr!ct!d Donor - A donor 2o donat!/ a $nt of +lood for a /0!c5c 0at!nt.

T!/! donor/ /o$ld m!!t all /$ta+lt% r!9$r!m!nt/ and +! t!/t!d a/

allo#!n!c donor/. Occa/onall%1 a dr!ct!d donaton ma% not m!!t all

/$ta+lt% and t!/tn# r!9$r!m!nt/1 n 2c ca/!1 t! 0at!nt*/ 0%/can

ma% mak! a m!dcal d!c/on to $/! t! dr!ct!d donaton.


41/44

D$ - A 3arant or 2!ak form of t! D ant#!n no Ant-D$ r!a#!nt !H/t/1 +$t

c!ll/ ar! t!/t!d for t! 3arant +% an ndr!ct ant#lo+$ln m!tod1 or t!

!9$3al!nt1 /$c a/ a /0!cal cann!l on t! Kontron Gro$0amatc1 Ol%m0$/

PK=>>1 or Gamma STS-M a$tomat!d +lood #ro$0!r/.

ELISA Scr!!nn# T!/t - ELISA ,al/o r!f!rr!d to a/ EIA / an acron%m for

!n%m!-lnk!d mm$no/or+!nt a//a%. T/ a//a% $tl!/ t! 0rnc0l! of a

/old 0a/!1 !.#.1 +!ad/ or mcrott!r 0lat! 2!ll/1 coat!d 2t ant#!n or

ant+od% and an ndcator r!a#!nt1 ant+od% or ant#!n1 r!/0!ct3!l%1 to 2c

an !n%m! a/ +!!n con6$#at!d or lnk!d.

A t%0cal ELISA t!/t /$c a/ tat $/!d for t! d!t!cton of ant+od% to 'I)$tl!/ +!ad/ or mcrott!r 2!ll/ coat!d 2t d/r$0t!d1 nact3at!d 'I)

a#!nt/ and #oat ant-$man I# con6$#at!d or lnk!d to an !n%m!1 2c on

nc$+aton 2t t! a00ro0rat! /$+/tanc!1 2ll 0rod$c! a color.

(!n an $nkno2n /!r$m or 0la/ma /am0l! / t!/t!d for t! 0r!/!nc! of

ant+od!/1 t / 0lac!d n t! ant#!n coat!d 2!ll/1 t! ant+od% n t!

/am0l! lnk/ to t! ant#!n on t! /old-0a/! carr!r and / d!t!ct!d +% t!

ant-$man ant+od!/ con6$#at!d to t! !n%m!. Po//+l! r!/$lt/ ncl$d!4

Intall% r!act3! - Intal EIA t!/t / r!act3!.

&!0!at!dl% r!act3! - On! or +ot d$0lcat! EIA r!t!/t/ /Jar! r!act3!.

N!#at3! - Intal EIA t!/t / non-r!act3! or f r!act3!1 +ot r!0!at d$0lcat!

EIA*/ ar! nonr!act3!.

Po/t3! - &!0!at!dl% r!act3! EIA t!/t1 (!/t!rn Blot ,(B 0o/t3!.

(B nd!t!rmnat! - (!/t!rn +lot n!t!r 0o/t3! nor n!#at3!.


42/44

EIA nd!t!rmnat! - &!0!at!dl% r!act3! EIA t!/t1 (!/t!rn +lot n!#at3! or

nd!t!rmnat!.

'!matocrt - T! 0!rc!nta#! of r!d +lood c!ll/ 0r!/!nt n t! 2ol! +lood

3ol$m!.

'!mo#lo+n - T! man com0on!nt of t! r!d +lood c!ll - an ron contann#

0rot!n 2c /!r3!/ a/ t! 3!cl! for t! tran/0ortaton of oH%#!n and

car+on doHd!.

Ma6or Cro//matc - Pat!nt*/ /!r$m t!/t!d 2t donor*/ r!d c!ll/ t! 0$r0o/!

/ to d!t!rmn! f t! 0at!nt a/ an ant+od% to an ant#!n fo$nd on t!

donor*/ c!ll/.

Mnor Cro//matc - Donor*/ /!r$m t!/t!d 2t 0at!nt*/ r!d c!ll/ t! 0$r0o/!

/ to d!t!rmn! f t! donor a/ an ant+od% to an ant#!n fo$nd on t!

0at!nt*/ c!ll/.

Pla/ma - S!0arat!d from r!d +lood c!ll/ 2tn 8 da%/ aft!r 0l!+otom%

,2tn da%/ aft!r 0l!+otom% 2!n CPDA-7 /ol$ton / $/!d a/ t!

antcoa#$lant. Stor!d at -7oC or cold!r 2tn /H o$r/ aft!r /!0araton

,/!! n/tr$cton +ookl!t. Datn# 0!rod / 53! %!ar/. Plat!l!t/ andJor

Cr%o0r!c0tat!d A'F ma% +! r!mo3!d from 0rod$ct.

7. L9$d 0la/ma4 S!0arat!d from r!d +lood c!ll/ 2tn 8 da%/ aft!r

0l!+otom% ,2tn da%/ aft!r 0l!+otom% 2!n CPDA-7 /ol$ton / $/!d

a/ t! antcoa#$lant. Stor!d at 7-oC for a total of 8 da%/ , da%/ 2!nCPDA-7 / $/!d.

8. Fr!/ Fro!n Pla/ma4 Coll!ct!d 2t mnmal dama#! to t//$!/. S!0arat!d

from r!d +lood c!ll/ and fro!n /old 2tn /H o$r/. Som! man$fact$r!r/

a3! r!c!3!d a00ro3al for t!r coll!cton /%/t!m/ to allo2 room

t!m0!rat$r! /tora#! +!for! 0la/ma /!0araton to +! !Ht!nd!d to !#t o$r/


43/44

,/!! n/tr$cton +ookl!t. Stor!d at -7oC or cold!r for $0 to on! %!ar.

:. Plat!l!t &c Pla/ma4 Coll!ct!d 2t mnmal dama#! to t//$!/. S!0arat!d

from r!d +lood c!ll/ 2tn /H o$r/ aft!r 0l!+otom% ,/!! n/tr$cton

+ookl!t. Proc!d$r! m$/t 0rod$c! a 0rod$ct 2t at l!a/t 8@>1>>>

0lat!l!t/Jmcrolt!r. Stor!d at 7-oC for =8 o$r/1 or at 8>-8@: #mJml @>> ml @8.@ #m.

SOP - Standard o0!ratn# 0roc!d$r!/.

STS - S!rolo#cal t!/t for /%0l/1 !.#.1 )D&L1 &P&1 and t! tr!0on!ma-+a/!d

!ma##l$tnaton t!/t on t! Ol%m0$/ a$tomat!d +lo

V t/ 0r!/!ntaton / tr$ncat!d !Hactl% n t! form a/ 0r!/!nt!d +% FDA on

t! nt!rn!t at tt04JJ222.fda.#o3JoraJn/0!ctWr!fJ#/J+lood.tml X
http://www.fda.gov/ora/inspect_ref/igs/blood.htmlhttp://www.fda.gov/ora/inspect_ref/igs/blood.html


44/44

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FDA Blood Bank & Blood Tranfusion

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