LABORATORY, PATHOLOGY AND

BLOOD SERVICES

Laboratory records, uness ot!er"#se
s$ec#%#ed
& years
C#n#ca aboratory $er'#t $er'anent
I''uno!e'atoo(y and tran%us#on test
and re$orts
) years
Bood and bood *ua#ty contro and
test#n( records
ater o% ) years a%ter $rocess#n( records are
co'$eted or + 'ont!s a%ter e,$#rat#on- $er'anent #%
no e,$#rat#on
Po#c#es to #nsure $os#t#.e #dent#%#cat#on o%
a bood or bood $roduct rec#$#ent
/0 years
Cert#%#cat#on o% (ood !eat! o% donors %or
'anu%acture o% Pas'a Cryo$rec#$#tated
AH1 or Source Pas'a
2 years
Co'$a#nts o% ad.erse react#ons re(ard#n(
eac! un#t o% bood or bood $roduct#on
ar#s#n( as a resut o% bood coect#on or
trans%us#on
2 years
3r#tten re$ort o% #n.est#(at#ons o% eac!
re$orted ad.erse bood coect#on or
trans%us#on react#on
2 years
Bood ban4 co'$at#b##ty records 2 years
Records or re'ed#a act#ons ta4en to
$re.ent %uture recurrences or trans%us#on
react#ons
2 years
Co$y o% bood donor re(#stry sent to bood
ban4 by PA De$t5 o% Heat!
'ost recent
3r#tten $rocedures %or coect#on,
$rocess#n(, co'$at#b##ty test#n(, stora(e
and d#str#but#on o% bood and bood
co'$onents %or !o'oo(ous trans%us#on,
autoo(ous trans%us#on and %urt!er
'anu%actur#n( $ur$oses
/0 years
6anua o% standard o$erat#n( $rocedures
and 'et!ods %or bood coect#n( and
trans%us#on
/0 years
6anu%actur#n( records o% b#oo(#ca ater o% ) years a%ter records o% 'anu%acture
$roducts #censed by Secretary o% HHS co'$eted or + 'ont!s a%ter t!e atest e,$#rat#on date
%or #nd#.#dua $roduct
Record o% na'e and *ua#%#cat#ons o%
$erson #''ed#atey #n c!ar(e o%
e'$oyees "!o deter'#ne su#tab##ty o%
donors or coect bood "!en a $!ys#c#an
#s not $resent on t!e $re'#ses
2 years
Records reated to bood coect#on,
$rocess#n(, co'$at#b##ty test#n(, stora(e
and d#str#but#on
ater o% ) years a%ter t!e records o% $rocess#n( !a.e
been co'$eted or + 'ont!s a%ter t!e atest
e,$#rat#on date %or t!e #nd#.#dua $roduct5 3!en
t!ere #s no e,$#rat#on date, records s!a be reta#ned
#nde%#n#tey
Cytoo(y s#de $re$arat#ons not oaned to
$ro%#c#ency test#n( $ro(ra's
$er'anent
Pat!oo(y test re$orts $er'anent
3r#tten $rocedures %or re$ort#n( #''#nent
#%e7t!reaten#n( aboratory resuts or $an#c
.aues
$er'anent
Records o% aboratory8$at!oo(y
e*u#$'ent 'a#ntenance and %unct#on
c!ec4s
#%e o% e*u#$'ent
Pre'a#(nant and 'a#(nant sect#on s#de
$re$arat#ons
$er'anent
H#sto$at!oo(y sta#ned s#des $er'anent
H#stoco'$at#b##ty records $er'anent
Auto$sy records $er'anent
C#n#ca, sur(#ca, $at!oo(y and cytoo(y
records
$er'anent
Testing Records Blood Donor Records Blood Transfusion Records (Blood Bank) (I would
recommend the following description: Records that document records maintained in a blood
bank which record the donor information, storage and distribution of the product, compatibility
testing, uality control records, transfusion reaction reports and complaints, and general
records! Records may include the logs which indicate on"hand in#entory and notices of
emergency shortages! $eneral records are described as records of the sterili%ation of supplies
and reagents, responsible personnel, errors and accidents, maintenance of euipment and the
physical plant, and the e&piration dates of supplies and reagents! 'uality control records
include: calibration and standardi%ation of euipment, performance checks, periodic check of
sterile techniue, and periodic tests of the capacity of shipping containers to maintain the proper
temperature! (ompatibility tests include the results of cross"matching, antibody screenings, and
the results of confirmation testing! )torage and distribution records include: the distribution and
disposition of the blood product* #isual inspection of whole blood and red blood cells during
storage and immediately before distribution* storage temperature control and initialed
temperature log or recorder chart* and emergency releases of blood including a physician+s
signature! Donor records include: donor selection , informed consent, medical inter#iew and
e&amination, permanent and temporary deferrals, donor ad#erse reaction complaints and
reports, in#estigation and follow"up, therapeutic bleedings, immuni%ation, and blood collection
including phlebotomist+s name!
T!e $ur$ose o% t!e Records Po#cy #s to 'a#nta#n t!e #nte(r#ty o% E'ory records %or
ad'#n#strat#.e, e(a, %#nanc#a, and !#stor#ca $ur$oses5 A record #s any recorded #n%or'at#on
re(ardess o% 'ed#a, c!aracter#st#cs, $!ys#ca %or', or 'eans o% trans'#ss#on 'ade or rece#.ed
and 'a#nta#ned by E'ory $ursuant o% #ts e(a ob#(at#ons or #n t!e transact#on o% #ts bus#ness5
A records created by $ersons e'$oyed or act#n( on be!a% o% E'ory #n t!e course o% carry#n(
out t!e#r res$ons#b##t#es are $ro$erty o% E'ory and not t!e $ro$erty o% t!e #nd#.#dua5 No records
can be destroyed or ot!er"#se d#s$osed o% "#t!out t!e consent o% t!e des#(nated E'ory o%%#c#a
under t!e ter's o% an a$$ro.ed records sc!edue5 A records 'ust be sc!edued %or d#s$os#t#on
t!rou(! t!e 9n#.ers#ty Records and In%or'at#on 6ana(e'ent Pro(ra'5 Records $erta#n#n( to
any current or ant#c#$ated #n.est#(at#on, e(a act#on or $roceed#n( 'ay not be destroyed or
ot!er"#se d#s$osed o%, e.en #% t!e sc!edued retent#on $er#od !as e,$#red or t!e d#s$os#t#on date
!as arr#.ed5 D#s$os#t#on #ncudes but #s not #'#ted to t!e %oo"#n( act#ons:
Destruct#on
Trans%er %ro' one 'ed#u' to anot!er ;#5e5 %ro' $a$er to d#(#ta or '#cro%#'<
6o.e'ent to a$$ro.ed o%%s#te8on s#te stora(e
Trans%er to 9n#.ers#ty Arc!#.es ;a$$#es ony to t!at s'a $ercenta(e o% t!e 9n#.ers#ty=s
records deter'#ned to !a.e endur#n( #n%or'at#on or e.#dent#a .aue<
FDA BLOOD BANK INSPECTION GUIDE
BLOODBOOK.COM

PRESENTED ON THIS PAGE
IS AN ACTUAL FDA BLOOD
BANK INSPECTION GUIDE
WHICH WILL GIVE AN IDEA
OF BLOOD BANK
INSPECTION ISSUES.
TO HOME PAGE
Don't forget to oo!"#r! B$oo%Boo!.&o"' (CTRL)D*
CLOSE WINDOW
T+,- .#ge/ .re-ente% e$o0 t+e re% $,ne/ ,- %,re&t$1 fro" t+e FDA. It +,g+$,g+t-
.ro&e%2re- #n% g2,%e$,ne- for ,n-.e&t,on of B$oo% #n!- #n% ,- referen&e "#ter,#$
for ,n3e-t,g#tor- #n% ot+er FDA .er-onne$. We +#3e not &+#nge% one -,ng$e 0or%
of t+,- %o&2"ent e$o0 t+e re% $,ne. It ,- .re-ente% 2n&+#nge% for ,nfor"#t,on#$
.2r.o-e- #n% for # .o,nt of referen&e #- 1o2 re#% -o"e of t+e "#ter,#$- on
B$oo%Boo!.&o"
Blood Bank Inspections
Note: This document is reference material for investigators and other FDA
personnel. The document does not bind FDA, and does no confer an rights,
privileges, benefits, or immunities for or on an person!s".
#$ID% T& IN'(%)TI&N' &F B*&&D BAN+'
TAB*% &F )&NT%NTS
'ub,ect ...5555555555555555555555555555555555555555555555555555555555555555.............(age
Introduct#on5555555555555555555555555555555555555555555555555555555555555555555555555555P( /
Genera In%or'at#on55555555555555555555555555555555555555555555555555555555555555555P( /
O$erat#ons5555555555555555555555555555555555555555555555555555555555555555555555555555555P( >
Records55555555555555555555555555555555555555555555555555555555555555555555555555555555555P( >
Errors, Acc#dents and 1ata#t#es5555555555555555555555555555555555555555555555555P( >
1ac##t#es, E*u#$'ent and Personne5555555555555555555555555555555555555555555P( ?
@ua#ty Assurance555555555555555555555555555555555555555555555555555555555555555555555P( &
D#s$osa o% In%ect#ous 3aste555555555555555555555555555555555555555555555555555555P( &
Part A 7 3!oe Bood, Donor Su#tab##ty555555555555555555555555555555555555P( &
Part B 7 Laboratory5555555555555555555555555555555555555555555555555555555555555555555P( 2
Part C 7 Red Bood Ces55555555555555555555555555555555555555555555555555555555555P( /0
Part D 7 Pas'a and Reco.ered Pas'a5555555555555555555555555555555555555P( />
Part E 7 Pateets555555555555555555555555555555555555555555555555555555555555555555555555P( />
Part 1 7 Cryo$rec#$#tated AH155555555555555555555555555555555555555555555555555P( />
Part G 7 9n#%or' Bood Labe#n(555555555555555555555555555555555555555555555555P( /?
Part H 7 Co'$at#b##ty Test#n( and Trans%us#on React#ons555555555555P( /?
Part I 7 Stora(e, D#str#but#on5555555555555555555555555555555555555555555555555555555P( /&
Part A 7 Pateets, P!eres#s55555555555555555555555555555555555555555555555555555555555P( /)
Part B 7 Co'$uter#Cat#on555555555555555555555555555555555555555555555555555555555555P( /)
Ter's and Abbre.#at#ons5555555555555555555555555555555555555555555555555555555555555P( /)
INT-&D$)TI&N
T!e DGu#de to Ins$ect#ons o% Bood Ban4sD #s a conso#dat#on o% #n%or'at#on
$re.#ousy $ro.#ded #n t!e Bood Ban4 Ins$ect#on C!ec4#st and Re$ort, and t!e
Instruct#on Boo4et %or Bood Ban4 Ins$ect#on C!ec4#st and Re$ort, 1DA7>+0E5
T!#s (u#de, "!#c! $ro.#des t!e 'ost u$dated #nter$retat#on o% certa#n re(uat#ons and
(u#de#nes, "as $re$ared by t!e 1DA, O%%#ce o% Re(uatory A%%a#rs and t!e Center
%or B#oo(#cs E.auat#on and Researc!5
T!e Bood Ban4 Ins$ect#on C!ec4#st and Re$ort, and t!e Instruct#on Boo4et %or
Bood Ban4 Ins$ect#on C!ec4#st and Re$ort, 1DA7>+0E, are no on(er #n e%%ect5
Conse*uenty, %#ed #n.est#(ators are no on(er re*u#red to %# out t!e c!ec4#st
dur#n( estab#s!'ent #ns$ect#ons nor sub'#t #t "#t! #ns$ect#ona re$orts5
T!e c!ec4#st and #nstruct#on boo4et "ere ast $ub#s!ed #n 6ay /EE/5 S#nce 6ay
/EE/, CBER #ssued a nu'ber o% 'e'oranda to #ndustry, de$#ct#n( ne"
reco''endat#ons, and 'od#%#cat#ons to $re.#ous (u#dance, #n add#t#on to (u#de#nes
on *ua#ty assurance and .a#dat#on o% co'$uter syste's5 At!ou(! t!e a(ency, at
t!e t#'e o% t!#s $ub#cat#on, #s #n t!e $rocess o% re.#s#n( t!e re(uat#ons on bood and
bood $roducts, #t "# ta4e so'e t#'e be%ore suc! re.#s#ons are #n e%%ect5 T!e current
(u#de $ro.#des #nter#' #ns$ect#ona d#rect#on5
T!#s re%erence $ro.#des t!e 'ost u$dated #nter$retat#on o% certa#n re(uat#ons and
(u#de#nes5 T!#s re%erence #s not #ntended to be a DHo" to555D #t #s a tec!n#ca
re%erence and #s #ntended to be used #n conFunct#on "#t! t!e Ins$ect#on O$erat#ons
6anua ;IO6<, t!e Code o% 1edera Re(uat#ons, T#te >/ ;>/ C1R<, t!e Co'$#ance
Pro(ra' %or t!e Ins$ect#on o% L#censed and 9n#censed Bood Ban4s ;CP 2?&>500/<
and t!e Co'$#ance Po#cy Gu#des %or b#oo(#cs ;CPG 2/?&<5
In se.era #nstances t!e 'anua re%ers to 'e'oranda $ub#s!ed by CBER and sent to
re(#stered bood estab#s!'ents5 T!ese 'e'oranda s!oud be a.a#abe at t!e 1DA
D#str#ct O%%#ces, #% not, a co$y can be obta#ned %ro' CBER, D#.#s#on o% Ins$ect#ons
and Sur.e#ance, O%%#ce o% Co'$#ance, ;?0/< )E&7//E&5
T!e $re$arat#on o% $roducts %or "!#c! t!ere are no $ub#s!ed Add#t#ona Standards
'ust be descr#bed #n t!e estab#s!'entGs SOP 'anua and 'anu%actured #n
accordance "#t! t!e 'et!ods t!ere#n5 T!e #n.est#(ator s!oud o%%er no ad.#ce or
reco''endat#on to t!e 'anu%acturer re(ard#n( t!e $re$arat#on o% suc! $roducts5
@uest#ons concern#n( $ract#ces "!#c! 'ay be !aCardous s!oud be addressed to t!e
D#.#s#on o% Ins$ect#ons and Sur.e#ance ;H167+)0< at ;?0/< )E&7//E&5
#%N%-A* INF&-.ATI&N
In.est#(ators s!oud note t!e 95S5 L#cense nu'ber, #% a$$#cabe ;and ocat#on
nu'ber< o% %ac##t#es5 T!#s "# ser.e to #dent#%y estab#s!'ents #n corres$ondence,
a$$#cat#ons and ot!er %or's o% co''un#cat#ons5 Re(#strat#on nu'bers, essent#ay
centra %#e nu'bers, are not t!e sa'e as #cense nu'bers5
T!e estab#s!'ent s!oud !a.e a .a#dated $#n4 co$y o% 1or' 1DA7>H?0, Bood
Estab#s!'ent Re(#strat#on and Product L#st#n(, %or t!e current caendar year or
e.#dence o% !a.#n( sub'#tted sa'e5 I% t!e data on t!e re(#strat#on %or' #s not
correct, #st correct#ons to be 'ade #n co''ents, and #nstruct t!e estab#s!'ent to
sub'#t #n "r#t#n( t!e u$dated #n%or'at#on to t!e D#.#s#on o% Bood A$$#cat#ons,
;H167?20<, /&0/ Roc4.#e P#4e, Roc4.#e, 6D >0H)>7 /&&H5 I% c!an(es #n t!e
na'e and address, 6ed#ca D#rector, 'anu%actur#n( $rocedures, or $roducts !a.e
occurred, t!ey s!oud be re$orted to DBA #n order to u$date t!e 1or' 1DA7>H?05
In un#censed !os$#ta bood ban4s, as a 'atter o% courtesy, t!e !os$#ta
ad'#n#strator s!oud be not#%#ed t!at t!e bood ban4 #s to be #ns$ected5
&(%-ATI&N'
Deter'#ne "!et!er un#censed $roducts are s!#$$ed #nterstate %or sae, barter, or
e,c!an(e and, #% so, t!orou(!y docu'ent suc! s!#$'ents5 T!e re*u#re'ents o% >/
C1R +&0, Sub$art G a$$y to $as'a e,c!an(e #% t!e resut#n( $as'a #s sod5
Deter'#ne a$$ro,#'atey !o" 'any un#ts o% "!oe bood are coected annuay,
!o" 'any are autoo(ous, and !o" 'any are d#rected5 Aso, deter'#ne !o" 'any
un#ts o% "!oe bood and red bood ces ;RBCs< are rece#.ed %ro' outs#de sources
eac! year, !o" 'any are autoo(ous and !o" 'any are d#rected5
Deter'#ne "!#c! $roducts are $re$ared and act#.#t#es conducted5
L#censed estab#s!'ents are re*u#red to re$ort c!an(es #n 'anu%actur#n( to CBER5
So'e estab#s!'ents sub'#t SOPs #n re$ort#n( t!ese c!an(es5 Not a $rocedures are
re.#e"ed by CBER- t!ere%ore, #% an #n.est#(ator obser.es a $rocedure s8!e cons#ders
unsa%e %or t!e donor or t!at "# a%%ect t!e sa%ety, $ur#ty, or $otency o% t!e $roduct
contact t!e D#.#s#on o% Ins$ect#ons and Sur.e#ance at ;?0/<7)E&7//E/5 Re%er aso to
t!e Auy >/, /EE> 'e'orandu', DC!an(es #n E*u#$'ent %or Process#n( Bood
Donor Sa'$es5D
I% t!e %ac##ty be#n( #ns$ected #s #censed and $!eres#s $roducts, #5e, Pateets,
P!eres#s and 1res! 1roCen Pas'a, are $re$ared by auto'ated 'et!ods at ot!er
ocat#ons, t!e %#r'Gs #cense s!oud be a'ended to $er'#t t!ese $roducts coected at
t!e ot!er ocat#ons to be s!#$$ed #n #nterstate co''erce5
Leu4ocytes, (ranuocytes and 'onocytes coected by a$!eres#s are not #censed
bood co'$onents5 I% t!ese are s!#$$ed #nterstate, t!e #cense nu'ber 'ust not be on
t!e $roduct abe and t!e $roduct #s not to be sod, bartered, or e,c!an(ed5
-%)&-D'
In 'ass $roduct#on o% co'$onents, t!e on7s#te su$er.#sor, or ot!er res$ons#be
$erson, re.#e"#n( and a$$ro.#n( t!e records 'ay s#(n as t!e res$ons#be $erson %or
eac! (rou$ o% $roducts $re$ared5 1or #censed bood ban4s, t!#s $rocedure s!oud
rece#.e a$$ro.a %ro' CBER5
Records 'ust be 'a#nta#ned to $re.ent t!e d#str#but#on o% subse*uent un#ts o% bood
dra"n %ro' unsu#tabe donors5 9nsu#tabe donors #ncude, but are not #'#ted to,
t!ose "!o test re$eatedy react#.e %or ant#7HIV or HBsA( and !a.e not been
$ro$ery reentered or !a.e a 'ed#ca !#story "!#c! "oud $recude donat#on5 T!e
re(uat#ons do not $ro!#b#t %#r's %ro' coect#n( bood %ro' de%erred donors5 A %#r'
'ay coect bood %ro' de%erred donors #% #t #s not $recuded by #ts SOP- !o"e.er,
t!e %#r' 'ust !a.e a syste' to $re.ent t!e d#str#but#on o% t!ese bood co'$onents5
Re%er to 1DA reco''endat#ons #n current 'e'oranda to re(#stered bood
estab#s!'ents and8or t!e estab#s!'entGs SOPGs to deter'#ne t!at t!e a$$ro$r#ate
d#s$os#t#on o% bood co'$onents and de%erra o% donors occurs %or un#ts test#n(
re$eatedy react#.e5
%--&-', A))ID%NT' AND FATA*ITI%'
Re%er to CBERGs 'e'orandu' to re(#stered bood estab#s!'ents, dated 6arc! >0,
/EE/, t#ted DRes$ons#b##t#es o% Bood Estab#s!'ents Reated to Errors and
Acc#dents #n t!e 6anu%acture o% Bood and Bood Co'$onentsD5
Currenty, t!ere #s no re(uat#on t!at re*u#res un#censed, re(#stered bood
estab#s!'ents or trans%us#on %ac##t#es to sub'#t error and acc#dent re$orts to t!e
1DA5 Ho"e.er, a t!orou(! #n.est#(at#on and docu'entat#on o% correct#.e act#on #s
re*u#red5 A re*uest !as #ssued %or un#censed %ac##t#es and trans%us#on ser.#ces to
.ountar#y re$ort errors and acc#dents5
3!en a co'$#cat#on o% bood coect#on or trans%us#on #s con%#r'ed to be %ata, t!e
%ata#ty 'ust be re$orted to t!e O%%#ce o% Co'$#ance, ?0/7)E&7//E&, by t!e
coect#n( bood ban4 or by t!e %ac##ty t!at $er%or'ed t!e co'$at#b##ty test5 T!#s
re*u#re'ent #s %or any %ac##ty #n "!#c! t!e %ata#ty occurred5
In t!e e.ent t!at t!e #n.est#(ator beco'es a"are o% a $re.#ousy unre$orted %ata
donor or rec#$#ent react#on "!#c! occurred s#nce t!e ast #ns$ect#on, t!e D#rector,
D#.#s#on o% Ins$ect#ons and Sur.e#ance, ?0/7)E&7//E&, s!oud be not#%#ed as soon
as $oss#be5
*&&+BA)+ (&*I)/
See t!e A$r# >?, /EE> 'e'orandu', DRe.#sed Reco''endat#ons %or t!e
Pre.ent#on o% Hu'an I''unode%#c#ency V#rus ;HIV< Trans'#ss#on by Bood and
Bood ProductsD %or add#t#ona (u#dance5
(&'T D&NATI&N INF&-.ATI&N -%(&-T'
Re%er to CBERGs 'e'orandu' to #ndustry t#ted DGu#dance Re(ard#n( Post
Donat#on In%or'at#on Re$ortsD dated Dece'ber /0, /EE?5
FA)I*ITI%', %0$I(.%NT, (%-'&NN%*
FA)I*ITI%'
OSHA $ub#s!ed t!e %#na rue %or t!e DOccu$at#ona E,$osure to Boodborne
Pat!o(ensD #n t!e Dece'ber +, /EE/ 1edera Re(#ster5 Incuded #n t!e rue are
re*u#re'ents %or %ac##t#es to de.eo$ $rocedures to ensure t!e sa%ety o% e'$oyees
"#t! a $otent#a %or e,$osure to b#o!aCardous 'ater#as and $rocedures %or 'ed#ca
"aste d#s$osa5 1DA re*u#res !and7"as!#n( %ac##t#es %or sta%% dra"#n( and !and#n(
bood and t!e sa%e and san#tary d#s$osa o% tras!5 At so'e 'ob#e s#tes "!ere !and
"as!#n( %ac##t#es 'ay not be a.a#abe, an aternate 'et!od to cean !ands, #5e5,
bacter#c#da !and "#$es, #s acce$tabe5
T!e Centers %or D#sease Contro ;CDC< and t!e Nat#ona Inst#tutes o% Heat! ;NIH<
$ub#s!ed a boo4et ent#ted B#osa%ety #n 6#crob#oo(#ca and B#o'ed#ca
Laborator#es "!#c! reco''ends $recaut#ons aboratory e'$oyees s!oud %oo"5
T!e boo4et #s a.a#abe t!rou(! t!e De$art'ent o% Heat! and Hu'an Ser.#ces
;DHHS<5 It #s $ub#cat#on No5 ;CDC< HH7H?E), E&7E), >nd Ed#t#on, 3as!#n(ton, DC:
9S Go.ern'ent Pr#nt#n( O%%#ce, /EHH5
9naut!or#Ced $ersons 'ay not "ander t!rou(! an area "!ere bood #s be#n( dra"n,
t!ere%ore, t!e tra%%#c %o" o% t!e %ac##ty, es$ec#ay 'ob#e s#tes, 'ust be $ro$ery
'on#tored and controed5
T!e #nter.#e" area !as to o%%er t!e donor a de(ree o% $r#.acy so t!at t!e donor "#
be co'%ortabe ans"er#n( t!e *uest#ons "#t!out %ear o% be#n( o.er!eard5
%0$I(.%NT
Re%er to t!e CBER Auy >/, /EE> 6e'orandu' to #censed estab#s!'ents on
DC!an(es #n E*u#$'ent %or Process#n( Bood Donor Sa'$esD5 D#scuss#on o%
c!an(es #n e*u#$'ent %or ABO8RH and ant#body screen#n( #s $resented under Part B
Laboratory beo"5
I% e*u#$'ent #s used #n t!e estab#s!'ent t!at #s not #sted #n t!e C1R, $er%or'ance
c!ec4s and $re.ent#.e 'a#ntenance s!oud be $er%or'ed by t!e %#r' accord#n( to
t!e 'anu%acturerGs #nstruct#ons and8or SOPGs5
Dur#n( t!e course o% an #ns$ect#on, t!e #n.est#(ator 'ay obser.e or re.#e" #nstances
"!ere e*u#$'ent or su$$#es are e#t!er be#n( '#sused or not %unct#on#n( as
des#(ned5 Because o% '#suse, or ac4 o% ad!erence to SOPGs and8or 'anu%actur#n(
#nstruct#ons, t!e use o% 4ey e*u#$'ent or su$$#es creates c#rcu'stances "!ere
donor, o$erator, or $roduct sa%ety #s co'$ro'#sed5 It #s #'$ortant to e,a'#ne t!e
%#r'Gs o.era use o% e*u#$'ent and su$$#es to be certa#n t!at e*u#$'ent and
su$$#es are used accord#n( to d#rect#ons, sat#s%actor#y #ns$ected, 'a#nta#ned and
o$erat#n( $ro$ery5
T!e standard#Cat#on and ca#brat#on o% t!e !e'atocr#t centr#%u(e 'ay be done "#t! a
co''erc#ay $re$ared contro or by ot!er 'et!ods, e5(5, du$#cate sa'$es tested at
'ut#$e #nter.as5
S$ectro$!oto'eters used dur#n( .#ra test#n( s!oud be c!ec4ed $er#od#cay %or
#near#ty, dr#%t and re$eatab##ty accord#n( to 'anu%acturerGs #nstruct#ons5
Lar(er bood estab#s!'ents 'ay !a.e $urc!ased a centra te'$erature 'on#tor#n(
syste' to 'on#tor and record te'$eratures #n bood stora(e un#ts5 Once t!e syste' #s
#nstaed and #ts accuracy de'onstrated and docu'ented, a da#y co'$ar#son o% t!e
#nterna t!er'o'eter to t!e record#n( c!art8de.#ce #s not re*u#red5 Ho"e.er,
$er#od#c $er%or'ance c!ec4s co'$ar#n( ca#brated t!er'o'eters to syste' $r#ntouts
s!oud be $er%or'ed to assure t!e syste' #s %unct#on#n( accuratey5
Procedures s!oud $ro.#de %or t!e ca#brat#on o% t!e autoca.e be%ore #n#t#a use and
a%ter re$a#rs5 Ca#brat#on $rocedures s!oud $ro.#de assurance t!at t!e autoca.e
%unct#ons as #ntended, #5e5, ster##Cat#on o% ar' $re$arat#on su$$#es and8or
deconta'#nat#on o% b#o!aCardous 'ater#a5 B#oo(#c #nd#cators 'ust be used
$er#od#cay and a te'$erature contro, suc! as !eat sens#t#.e ta$e, s!oud be used
"#t! eac! run to .er#%y t!at t!e 'ater#as are be#n( ster##Ced5 A '#n#'u' o%
/>/5)oC ;>)/o1< %or +0 '#nutes by saturated stea' at a $ressure o% /) at'os$!eres
#s reco''ended %or 'ater#as conta'#nated "#t! bood- >0 '#nutes at t!e sa'e
te'$erature #s re*u#red %or ar' $re$arat#on su$$#es5
(%-'&NN%*
Bood ban4 $ersonne s!oud be %a'##ar "#t! a$$#cabe re(uat#ons reated to t!e#r
res$ect#.e tas4s5 Personne s!oud 4no" t!e ocat#on o% t!e SOP 'anua and be
4no"ed(eabe about t!ose sect#ons "!#c! $erta#n to t!e#r Fobs5
Sta%% o% 'ob#e s#tes 'ust !a.e t!e sa'e de(ree o% tra#n#n( and su$er.#s#on as %or
%#,ed donor s#tes ocated #n t!e bood ban4 or #n a donor center5 Vounteers are
$er'#tted to ass#st #n .ar#ous areas and 'ust be ade*uatey tra#ned5 Tra#n#n( s!oud
be docu'ented5
0$A*IT/ A''$-AN)%
Re%er to t!e DDra%t Gu#de#ne %or @ua#ty Assurance #n Bood Estab#s!'entsD, dated
Aune /2, /EE?5
T!#s $ub#cat#on ass#sts 'anu%acturers o% bood and bood co'$onents on
de.eo$#n( $rocedures and $ract#ces use%u %or ad'#n#ster#n( a *ua#ty assurance
$ro(ra'5 1ac##t#es 'ay %oo" t!e (u#de#ne or c!oose to use aternat#.e $rocedures
not $ro.#ded #n t!e docu'ent5 Ho"e.er, #% an estab#s!'ent c!ooses to use
aternat#.e $rocedures, t!e %ac##ty 'ay "#s! to d#scuss suc! $rocedures "#t! t!e
1DA to $re.ent e,$end#tures o% resources on act#.#t#es t!at 'ay be unacce$tabe to
t!e a(ency5
DI'(&'A* &F INF%)TI&$' 1A'T%
1DA ad.#ses t!at state and oca a"s s!oud be %oo"ed5 A bood conta'#nated
"aste s!oud be autoca.ed ;/>/5)oC8>)/o1 %or +0 '#nutes< or #nc#nerated5 T!e
%#r'Gs SOP s!oud conta#n s$ec#%#c an(ua(e %or d#s$osa o% conta'#nated "aste5
Needes s!oud be d#s$osed o% #n a conta#ner des#(ned to $re.ent acc#denta
$unctur#n( o% $ersonne5 I% conta'#nated "aste #s d#s$osed o% by a contract "aste
d#s$osa %#r', a contracted a(ree'ent s!oud be on %#e at t!e %ac##ty, and s$ec#%y
t!at B#o!aCardous 'ater#a #s d#s$osed o% a$$ro$r#atey accord#n( to EPA, state
and8or oca re(uat#ons5 Ina$$ro$r#ate d#s$osa $ract#ces s!oud be re%erred to state
aut!or#t#es %or %oo"7u$5
(A-T A 2 13&*% B*&&D D&N&- '$ITABI*IT/
Donor Su#tab##ty
Re%er to t!e %oo"#n( CBER 'e'oranda %or add#t#ona #n%or'at#on:
/5 DDonor Su#tab##ty Reated to Laboratory Test#n( %or V#ra He$at#t#s and a H#story
o% V#ra He$at#t#sD, dated Dece'ber >>, /EE?5
>5 DRe.#sed Reco''endat#ons %or Test#n( 3!oe Bood, Bood Co'$onents,
Source Pas'a and Source Leu4ocytes %or Ant#body to He$at#t#s C V#rus Encoded
Ant#(en ;ANT7HCV<, dated Au(ust ), /EE?5
?5 DDe%erra o% Bood and Pas'a Donors based on 6ed#cat#onsD, dated Auy >H,
/EE?5
&5 DRe.#sed Reco''endat#ons %or Test#n( 3!oe Bood, Bood Co'$onents,
Source Pas'a and Source Leu4ocytes %or Ant#body to He$at#t#s C V#rus Encoded
Ant#(en ;Ant#7HCV<, dated A$r# >?, /EE>5
)5 DRe.#sed Reco''endat#ons %or t!e Pre.ent#on o% HIV Trans'#ss#on by Bood
and Bood ProductsD, dated A$r# >?, /EE>5
+5 DE,e'$t#ons to Per'#t Persons "#t! a H#story o% V#ra He$at#t#s Be%ore t!e A(e
o% Ee.en Years to Ser.e as Donors o% 3!oe Bood and Pas'a: Aternat#.e
ProceduresD, dated A$r# >?, /EE>5
25 DCar#%#cat#on o% 1DA Reco''endat#ons %or Donor De%erra and Product
D#str#but#on Based on t!e Resuts o% Sy$!##s Test#n(: dated Dece'ber />, /EE/5
H5 D1DA Reco''endat#ons Concern#n( Test#n( %or Ant#body to He$at#t#s B Core
Ant#(en ;Ant#7HBc<D, dated Se$te'ber /0, /EE/5
E5 DReco''endat#ons %or t!e 6ana(e'ent o% Donors and 9n#ts t!at are In#t#ay
React#.e %or He$at#t#s B Sur%ace Ant#(en ;HBsA(<D, dated Dece'ber >, /EH25
/05 DHTLV7I Ant#body Test#n(D, dated No.e'ber >E, /EHH5
A $ersons donat#n( bood or bood co'$onents %or trans%us#on or %urt!er
'anu%actur#n( use s!oud rece#.e #n%or'at#on about t!e sa%ety o% bood $roducts #n
reat#on to AIDS e$#de'#oo(y and t!e #'$#cat#ons %or donors "!o !a.e en(a(ed #n
certa#n !#(!7r#s4 act#.#t#es5 T!e #n%or'at#on s!oud be "r#tten #n an(ua(e t!at
assures t!at t!e donor understands t!e de%#n#t#on o% !#(!7r#s4 be!a.#ors and t!e
#'$ortance o% se%7e,cus#on5 Procedures s!oud aso be a.a#abe t!at $er'#t
co''un#cat#on o% t!#s #n%or'at#on to .#suay #'$a#red, ##terate, or non7En(#s!
s$ea4#n( $ersons #% t!ey are $er'#tted to donate5 T!e $rocedures a$$#ed s!oud
$ro.#de an o$$ortun#ty at eac! .#s#t %or t!e donor to cons#der t!e #n%or'at#on and to
'a4e an #n%or'ed dec#s#on about "!et!er to donate5 +&05?
D&N&- 3I'T&-/
Te'$erature, Bood Pressure: T!e su((ested Dnor'aD bood $ressure .aue #s E07
/H0 ''8)07/00 ''5 A o" te'$erature #s usuay o% no s#(n#%#cance uness t!e
donor !as sy'$to's o% .#ra #ness5 Te'$erature con.ers#on: o1 I ;oC , E8)< J ?>-
oC I ;o1 7 ?>< , )8E5 A te'$erature on t!e day o% donat#on KI EE5+o1 ;?25)oC<
"oud te'$orar#y de%er a donor5 A te'$erature o% EEo1 ;?25>oC< %or 'ore t!an a
/0 days s!oud be e.auated be%ore donat#on "oud be ao"ed5
Acute Res$#ratory D#seases: Sy'$to's o% res$#ratory d#sease ;cods, #n%uenCa,
$ers#stent cou(!, sore t!roat< or ot!er 'an#%estat#ons o% u$$er res$#ratory d#sease
s!a be cause %or reFect#on unt# act#.e sy'$to's !a.e subs#ded5 Suc! sy'$to's
'ay be an eary #nd#cat#on o% a 'ore ser#ous #ness5
Ot!er Acute and C!ron#c D#s*ua#%y#n( D#seases: Con.us#ons, beed#n( d#sorders,
recent toot! e,tract#on ;"#t!#n 2> !ours<, 'aar#a, s4#n #n%ect#on at t!e $!eboto'y
s#te, cancer, tubercuos#s, d#abetes, and !eart d#sease s!oud be cause %or reFect#on5
In%ect#ous S4#n D#seases: 6#d s4#n d#sorders suc! as acne, $sor#as#s, or t!e ras! o%
$o#son #.y are not cause %or de%erra uness t!ey a%%ect t!e s4#n #n t!e $!eboto'y
area5 Donors "#t! bo#s or ot!er se.ere s4#n #n%ect#ons s!oud be de%erred unt# t!e
$!eboto'y area #s %ree o% #n%ect#on5 6aar#a: See t!e Auy >+, /EE& 'e'orandu',
DReco''endat#ons %or De%erra o% Donors %or 6aar#a R#s4D, %or add#t#ona
(u#dance5 CDC $ro.#des a boo4et, DHeat! In%or'at#on %or Internat#ona Tra.eers,D
"!#c! s!oud be used rat!er t!an t!e 'a$s t!at "ere once used5 T!#s boo4et #s
u$dated yeary and t!e %#r' s!oud be us#n( a recent ed#t#on5
Pas'a$!eres#s donat#ons t!at are aso used %or t!e $re$arat#on o% Pateets are not
e,e'$ted %ro' t!e 'aar#a restr#ct#ons5
He$at#t#s: Donors "!o !a.e !ad cose contact "#t! a $at#ent "#t! .#ra !e$at#t#s
s!oud be de%erred %or at east t"e.e 'ont!s5 Hos$#ta $ersonne "or4#n( #n areas
"!ere !e$at#t#s #s ende'#c, suc! as rena d#ays#s un#ts, s!oud be e,cuded %or at
east t"e.e 'ont!s a%ter e'$oy'ent #n suc! areas5 Pros$ect#.e donors "!o !a.e
rece#.ed HBIG %oo"#n( a !e$at#t#s e,$osure s!oud be de%erred %or at east />
'ont!s5
Acu$uncture $at#ents 'ay donate bood "#t!out a t"e.e 'ont! de%erra #% t!e
needes used !a.e been ster##Ced under $ro$er cond#t#ons5 I% t!e neede ster##Cat#on
$rocedure cannot be .er#%#ed by t!e bood ban4, t!e donor s!oud be de%erred %or
t"e.e 'ont!s5 T!e sa'e $r#nc#$e can be a$$#ed to ear or ot!er body $#erc#n(5 I%
ster#e $rocedures can be .er#%#ed to !a.e been used, t!e donor need not be de%erred5
Donors "!o !a.e been e,$osed to bood $ercutaneousy, #5e5, needest#c4s or
'ucous 'e'brane s$as!es, s!oud be de%erred %ro' donat#n( bood %or at east
t"e.e 'ont!s5
Donors "!o !a.e rece#.ed a un#t o% bood, bood co'$onent, or der#.at#.e ;ot!er
t!an cott#n( %actor der#.at#.es< "!#c! 'ay be a $oss#be source o% #n%ect#ous d#sease
are de%erred %or t"e.e 'ont!s a%ter rece#$t o% t!e $roduct5
A 'e'orandu' not#%y#n( a bood estab#s!'ents re(ard#n( de%erras %or
'ed#cat#ons #ncud#n( Accutane, Te(#son, Proscar and $#tu#tary Hu'an Gro"t!
Hor'one "as #ssued Auy >H, /EE?, DDe%erra o% Bood and Pas'a Donors based on
6ed#cat#ons5D I% a donor ad'#ts to ta4#n( 'ed#cat#ons, #5e5, as$#r#n or ant#b#ot#cs,
t!ere s!oud be %urt!er *uest#on#n( o% t!e donor to deter'#ne t!e reason %or ta4#n(
t!e 'ed#cat#on t!at '#(!t $recude donat#on ;#5e5, as$#r#n %or %e.er or ant#b#ot#c %or
#n%ect#on<5
An acce$tabe re%erence %or dru(8'ed#cat#on de%erra #s t!e Dru( 9se and Bood
Donor Acce$tab##ty Gu#de, Cutter B#oo(#ca, /EH?5
D#rected Donors: s!oud 'eet a su#tab##ty re*u#re'ents and be tested as ao(ene#c
donors5 Occas#onay, a d#rected donat#on 'ay not 'eet a su#tab##ty and test#n(
re*u#re'ents, #n "!#c! case, t!e $at#entGs $!ys#c#an 'ay 'a4e a 'ed#ca dec#s#on to
use t!e d#rected donat#on5
')-%%NIN# A-%A 0$A*IT/ )&NT-&*
T!e conta#ners %or t!e co$$er su%ate ;CuSO&< sout#on 'ust be co.ered "!en not #n
use so t!at t!e sout#on "# not e.a$orate5 In order to $re.ent d#ut#on o% t!e co$$er
su%ate, "!#c! '#(!t resut #n seect#on o% donors "#t! #nade*uate !e'o(ob#n e.es,
conta#ners 'ust be t!orou(!y dry be%ore use5 Generay, >) ' .#as o% co$$er
su%ate sout#on are used5 Because t!e bood:co$$er su%ate rat#o #s one dro$ o%
bood:one ' o% co$$er su%ate, t!e co$$er su%ate s!oud be d#scarded a%ter >)
donors !a.e been tested5
T!e co$$er su%ate sout#on used, "!#c! #s e*u#.aent to />5) ('8d !e'o(ob#n, !as
a s$ec#%#c (ra.#ty o% /50)?- CuSO& e*u#.aent to /?5) ('8d !e'o(ob#n !as a
s$ec#%#c (ra.#ty o% /50))5 T!e s$ec#%#c (ra.#ty s!oud be c!ec4ed $er#od#cay "#t! a
ca#brated !ydro'eter5
I% t!ere #s no cear d#st#nct#on bet"een acce$tabe and unacce$tabe donors, t!e
sout#ons s!oud be c!an(ed, or a d#%%erent 'et!od o% screen#n( donors s!oud be
cons#dered5 Co$$er su%ate screen#n( #s not a *uant#tat#.e $rocedure5 S$ec#%#c
'easure'ent o% !e'o(ob#n or !e'atocr#t 'ay #nd#cate t!at a donor reFected by t!e
co$$er su%ate $rocedure #s, a%ter a, acce$tabe5
T!ere are ne"er aboratory #nstru'ents a.a#abe to deter'#ne He'o(ob#n or
He'atocr#t #n bood donors ;He'ocue by Leo D#a(nost#cs AB, Hes#nbor(, S"eden
and He'atastat by Se$arat#on Tec!noo(y, Inc5 are e,a'$es o% suc! #nstru'ents<5
@ua#ty contro $rocedures s!oud be #n accordance "#t! 'anu%acturerGs #nstruct#ons
and t!e %#r'Gs SOP5
A-. (-%(A-ATI&N
Co''erc#a ar' $re$arat#on su$$#es are $re$ared by se.era 'anu%acturers, e5(5,
C#n#$ad Cor$orat#on and 6ar#on Sc#ent#%#c5 T!ese $roducts are not 'ar4ed ster#e
but 'ay be used to $re$are t!e donorGs ar' %or $!eboto'y5
Ar' $re$arat#on su$$#es, suc! as (auCe, cotton bas, and a$$#cators 'ay be
$re$ared by t!e estab#s!'ent5 I% t!e ar' $re$arat#on su$$#es are ster##Ced by a
centra su$$y "!#c! #s a $art o% a !os$#taGs o$erat#on, #t #s not necessary to obser.e
t!ese $re$arat#on $rocedures or to re.#e" t!e records %or t!ese su$$#es5
Ar' $re$arat#ons s!oud be done "#t! care and %or t!e %u a'ount o% t#'e as stated
#n t!e SOP, and #deay "#t! .#(orous scrubb#n(5
T!ere are se.era "ays to do a sat#s%actory ar' $re$arat#on5 Su%%#c#ent durat#on and
.#(or o% scrubb#n( are t!e 4ey %actors to re'o.a o% su$er%#c#a '#crobes "!#c! #s
t!e (oa o% t!e ar' $re$arat#on5 T!e %#na ste$ 'ust be a$$#cat#on o% a bacter#ostat#c
a(ent #n a non7o.era$$#n( s$#ra be(#nn#n( at t!e #ntended neede $uncture s#te and
e,tend#n( out"ard5
B*&&D )&**%)TI&N
A%ter t!e .en#$uncture area #s $re$ared, t!e .e#n 'ay be $a$ated abo.e or beo" t!e
$re$ared area- !o"e.er t!e s#te o% neede #nsert#on s!oud not be touc!ed $r#or to
.en#$uncture5 It #s not $er'#ss#be to $ut #od#ne or ster#e (auCe on t!e %#n(er to
$a$ate t!e #ntended .en#$uncture s#te5 Needes 'ay be used %or ony one
.en#$uncture5 I% a .en#$uncture #s unsuccess%u, a ne" neede 'ust be used and t!e
ar' $re$arat#on re$eated5
T!e co'$et#on o% t!e donat#on 'ay be s#(naed by a tr#$ scae or .acuu'7ass#st
'et!od based on 'ass or .ou'e5 Ot!er"#se, t!e ba( 'ust be "e#(!ed ;s$r#n(
scaes< and t!e %o" sto$$ed 'anuay5 T!e bood s!oud be '#,ed (enty ;e#t!er
'anuay or 'ec!an#cay< dur#n( coect#on5 T!e %#na un#t s!oud "e#(!
a$$ro,#'atey &>)7)>) (ra's $us t!e "e#(!t o% t!e conta#ner and ant#coa(uant
;a$$ro,#'atey E0 (ra's<5 Lo" .ou'e coect#ons, e5(5, $ed#atr#c autoo(ous
coect#ons, are acce$tabe $ro.#d#n( t!e estab#s!'ent !as an SOP5 1or o" .ou'e
coect#ons to be s!#$$ed #n #nterstate co''erce, t!e %ac##ty 'ust !a.e CBER
a$$ro.a5
Her'et#c sea#n( o% t!e bood ba( tub#n( #s acco'$#s!ed by one o% t!e %oo"#n(:
d#eectr#c sea#n(, 'eta ca'$, or ty#n( a t#(!t D"!#te 4notD #n t!e donor tub#n(5 T!e
contents o% t!e tub#n( s!oud be str#$$ed #nto t!e ba(, '#,ed "e, and t!e
ant#coa(uated bood ao"ed to re%# t!e tub#n(5 1oo"#n( str#$$#n( o% t!e tub#n(,
an add#t#ona !er'et#c sea s!oud be $aced cose to t!e ba( so as to $re.ent
ta'$er#n(, t!ereby ensur#n( 'a#ntenance o% a cosed syste'5
S$ec#%#c (ra.#ty o% "!oe bood I /50)? ('8'L %or bood conta#n#n( />5) ('8dL o%
!e'o(ob#n5 T!e %oo"#n( cacuat#on #s used to con.ert .ou'e to "e#(!t: /50)?
('8'L L )00 'L I)>+5) ('
T!ere are %#r's "#t! a$$ro.a %ro' CBER to coect 11P or ot!er $as'a by$roducts
us#n( !e'a$!eres#s de.#ces5 So'e %#r's are a$$ro.ed to a#*uot t!e 11P ;or ot!er
$roducts< #nto s'aer conta#ners us#n( a ster#e tub#n( connect#n( de.#ce ;STCD<5
An STCD #s a de.#ce "!#c! seas t"o $#eces o% D#4eD ;sa'e s#Ce and co'$os#t#on<
tub#n( to(et!er to 'a4e a ster#e connect#on5 L#censed estab#s!'ents 'ust !a.e
1DA a$$ro.a %or 'anu%actur#n( co'$onents "#t! an SCD5 1or add#t#ona (u#dance,
see t!e Auy >E, /EE& 'e'orandu', D9se o% an 1DA Ceared or A$$ro.ed Ster#e
Connect#n( De.#ce ;STCD< #n Bood Ban4 Pract#ce5D
B*&&D )&**%)TI&N )&NTAIN%-
Na'es o% bood conta#ner 'anu%acturers 'ay be %ound on t!e abes o% t!e bood
ba(s5 T!e conta#ners 'anu%actured by Cutter Laborator#es ;D#.#s#on o% 6#es<,
1en"a Laborator#es ;Ba,ter Heat!care Cor$orat#on<, and Teru'o Cor$orat#on
!a.e been a$$ro.ed by CBER5 A$$ro.ed ant#coa(uants #ncude ant#coa(uant
c#trate de,trose sout#on ;ACD<, ant#coa(uant c#trate $!os$!ate de,trose sout#on
;CPD and CP>D<, and ant#coa(uant c#trate $!os$!ate de,trose aden#ne sout#on
;CPDA7/<5
Coect#on sets 'ust be stored #n accordance "#t! t!e 'anu%acturerGs #nstruct#ons5
Ina$$ro$r#ate stora(e 'ay contr#bute to e.a$orat#on o% t!e
ant#coa(uant8$reser.at#.e sout#on, or to 'od (ro"t! on t!e conta#ner sur%ace5
*AB&-AT&-/ 'A.(*%'
P#ot ;aboratory< sa'$es conta#n#n( bood %or ABO, R!, ant#body screen#n( and
.#ra test#n( are coected at t!e t#'e o% donat#on5 T!e tubes 'ust be #dent#%#ed to
accuratey reate t!e' to t!e un#t5 T!e 'et!od used %or coect#on o% t!e $#ot sa'$e
s!oud be one t!at $recudes conta'#nat#on o% t!e donor un#t, '#n#'#Ces $ersonne
e,$osure to bood, and 'a#nta#ns donor sa%ety5 See t!e AABB Tec!n#ca 6anua,
%or 'et!ods o% $#ot sa'$e coect#on5
DATIN# (%-I&D
E,$#rat#on dates .ary %ro' >/ days %or ACD, CPD, and CP>D, ?) days %or CPDA7/
#n "!oe bood and red bood ces, to &> days %or red bood ces to "!#c! add#t#.e
sout#ons !a.e been added, #5e5, ADSOLR ;1en"a<, Nutr#ceR ;Cutter< and
O$t#soR ;Teru'o<5
A$T&*&#&$' B*&&D )&**%)TI&N
Autoo(ous un#ts are bood or bood $roducts coected %ro' a $erson %or !#s8!er
o"n use at a ater t#'e5 T!ese $rede$os#ted bood $roducts are !anded and
$rocessed as s#'#ary as $oss#be to !o'oo(ous un#ts5 CBER sent t!e %oo"#n(
'e'oranda concern#n( autoo(ous donat#ons to a re(#stered bood estab#s!'ents:
DGu#dance %or Autoo(ous Bood and Bood Co'$onentsD on 6arc! /), EHE and
DAutoo(ous Bood Coect#on and Process#n( ProceduresD on 1ebruary />, EE0 and
DD#s$os#t#on o% Bood Products Intended %or Autoo(ous 9se t!at Test Re$eatedy
React#.e %or Ant#7HCVD, dated Se$te'ber //, /EE/5
T3%-A(%$TI) (3*%B&T&./
T!era$eut#c $!eboto'#es are cons#dered to be a $rocedure #ntended to treat t!e
$at#ent %or certa#n d#sease states, t!ere%ore, a "r#tten doctorGs re*uest s!oud be
a.a#abe %or t!e $rocedure5 9n#ts o% bood t!at are coected %or t!era$eut#c
$!eboto'y 'ust be %uy tested and donors 'eet a su#tab##ty re*u#re'ents #% t!e
un#ts are to be trans%used or #% t!e $as'a "# be sod %or %urt!er 'anu%acture5
Se.era recas !a.e occurred due to ac4 o% test#n( o% reco.ered $as'a %ro'
t!era$eut#c un#ts $r#or to s!#$$#n( %or %urt!er 'anu%acture5
DONOR REACTIONS
A bood ban4 s!oud be a"are o% t!e nature and %re*uency o% donor react#ons5
Ade*uate records %or eac! react#on s!oud be 4e$t and s!oud #ncude %oo"7u$ #n
order to #nsure ade*uate donor $rotect#on5 T!e bood ban4Gs SOP 'anua s!oud #st
and descr#be donor react#ons #t cons#ders to be ad.erse, as "e as t!e $rocedures to
be %oo"ed %or !and#n( and #n.est#(at#n( t!ese react#ons5 Se.ere donor react#ons
'ay #ncude %a#nt#n(, con.us#ons, se.ere !e'ato'as ;#n%#trat#on<, or #nFury caused
by %a#n(5 6#d donor react#ons #ncude %ee#n( %a#nt, nauseated, or d#CCy5
(A-T B 2 *AB&-AT&-/
AB& AND -3 T%'TIN#, and -B) Antibod 'creening
Bood Grou$#n( Rea(ents are used to deter'#ne t!e bood (rou$5 Ant#7A "#
a((ut#nate or cu'$ (rou$ A red ces5 Ant#7B "# a((ut#nate (rou$ B red ces5
Ant#7D #s used to deter'#ne R!o ;D< %actor5
L#censed ant#sera 7 so'e estab#s!'ents 'ay Dot!er"#se 'eet t!e re*u#re'entsD %or
ABO and R! #censed ant#bod#es by $roduc#n( t!e#r o"n ant#sera5 I% so, $roduct#on
records t!at are #n co'$#ance "#t! t!e re*u#re'ents %or t!e 'anu%acture o% t!ese
$roducts s$ec#%#ed #n >/ C1R ++0, Sub$art C 'ust be 4e$t5 L#censed bood ban4s
'ust !a.e CBER a$$ro.a to use suc! ant#sera5
Test 'et!ods used %or ABO, R! and ant#body screen#n(, "!#c! are d#%%erent %ro'
t!e 'anu%acturerGs #nstruct#ons, s!oud not be c#ted as de.#at#ons #% t!ey are not
$ro!#b#ted by t!e 'anu%acturer, !a.e been de'onstrated to be sat#s%actory, or !a.e
been a$$ro.ed %or use by CBER5 1or e,a'$e, t!e 6#crot#terT6 $ates and
Grou$a'at#cT6 'ac!#nes 'ay be used %or ABO, R!, and ant#body test#n(5 T!e
rea(ents 'ust be tested and s!o"n to $er%or' ade*uatey or sat#s%actor#y "!en
us#n( t!ese tec!n#*ues5
Bood "!#c! tests R!o;D< ne(at#.e 'ust be con%#r'ed by %urt!er test#n( ;usuay
Du< uness #t #s abeed #n accordance "#t! >/ C1R +&05);c<5 Acce$tabe 'et!ods %or
%urt!er test#n( to con%#r' D ne(at#.es #ncude use o% t!e ant#(obu#n 'et!od, and
use o% a s$ec#a c!anne on t!e Bontron Grou$a'at#c, Oy'$us PB200, or t!e
Ga''a STS76 auto'ated bood (rou$ers5 L#censed bood estab#s!'ents s!oud
!a.e a etter %ro' CBER a$$ro.#n( t!e#r use o% an auto'ated bood (rou$er %or Du
test#n(5
Not a ant#7D rea(ents 'ay be used %or Du test#n(- t!e $ac4a(e #nsert 'ust #ncude
d#rect#ons %or Du test#n(5
Procedures !a.e been a$$ro.ed to use rea(ents "#t! t!e Grou$a'at#cT6 beyond t!e
dat#n( $er#od, $ro.#ded a $ro$er set o% contros #s used5 L#censed estab#s!'ents
s!oud !a.e a etter %ro' CBER on %#e #nd#cat#n( t!at a $rotoco !as been sub'#tted
and a$$ro.ed %or t!#s $rocedure5 Rare rea(ents, e5(5, ant#7A4b, ant#7 Leb, etc5, are
so'et#'es used beyond t!e e,$#rat#on date- t!#s #s acce$tabe ony #% ade*uate
contros are used and t!e react#.#ty and s$ec#%#c#ty o% t!e rea(ents are docu'ented5
T!e react#.#ty and s$ec#%#c#ty o% rea(ents are (eneray con%#r'ed by test#n( at east
one $os#t#.e and one ne(at#.e contro sa'$e5 T!e ne(at#.e contros are not essent#a
%or ABO rea(ents because t!e ant#t!et#ca ce and seru' resuts $ro.#de
con%#r'at#on o% test accuracy5 T!e Ant#7Hu'an Gobu#n ;Coo'bs< rea(ent 'ust be
tested eac! day o% use "#t! an I(G sens#t#Ced ;DCoo'bsD contro or Dc!ec4D< ce5
T!e 'anu%acturerGs #nstruct#ons s$ec#%y t!at t!e stora(e re*u#re'ent %or Ant#7A,
Ant#7B, and Ant#7D rea(ents #s bet"een >7HoC- !o"e.er, #t #s acce$ted $ract#ce %or
t!ese rea(ents to stay at roo' te'$erature %or t!e durat#on o% t!e "or4#n( day5 T!#s
"# usuay not d#'#n#s! t!e $otency o% t!e $roducts t!rou(!out t!e nor'a $er#od
o% use5
A$T&.AT%D T%'T' F&- AB& 4 -3 T%'TIN#
Re%er to t!e Auy >/, /EE> CBER 'e'orandu' to #censed estab#s!'ents on
DC!an(es #n E*u#$'ent %or Process#n( Bood Donor Sa'$esD5 T!#s docu'ent
$ro.#des s$ec#%#c (u#dance on t!e docu'entat#on o% c!an(es #n e*u#$'ent,
s$ec#%#cay ca#brat#on, .a#dat#on, $arae test#n(, *ua#ty contro, 'a#ntenance and
e'er(ency $ans5
Laboratory records %or auto'ated test#n( s!oud #ncude t!e na'e o% t!e $erson "!o
$re$ared t!e rea(ents5 I% t!e syste' does not $ro.#de $os#t#.e sa'$e #dent#%#cat#on,
a record 'ust be 'ade %or t!e oad#n( $attern and t!e record 'ust #ncude t!e na'e
o% t!e $erson;s< "!o oaded and unoaded t!e sa'$er- #% resuts are .#suay
#nter$reted, t!e record 'ust #ncude t!e na'e o% t!e $erson;s< #nter$ret#n( and
trans%err#n( t!e resuts5
I% t!e %#r' used auto'ated 'et!ods %or ABO and R! ty$#n( at t!e t#'e o% #censure,
a se$arate etter o% a$$ro.a %ro' CBER %or auto'ated ABO and R! test#n( "# not
be #ssued to t!e estab#s!'ent5 Rea(ents used #n '#cro$ate test syste's s!oud be
reco''ended %or t!#s use by t!e 'anu%acturerGs $ac4a(e #nsert5 I% not or#(#nay
#censed %or t!e use o% t!e '#cro$ate test syste', a #censed estab#s!'ent s!oud
!a.e on %#e a etter %ro' CBER a$$ro.#n( #ts use5 Ga''a76#cro79 '#crot#ter
$ates are a$$ro.ed %or use ony "#t! t!e Ga''a '#crot#ter rea(ent uness t!e
rea(ent !as been e.auated and %ound acce$tabe %or suc! use accord#n( to an
estab#s!ed $rotoco5
Occas#onay an auto'ated bood (rou$#n( #nstru'ent #s unabe to #nter$ret an ABO
or R! resut5 T!e %#r' s!oud !a.e an SOP to %oo"7u$ "#t! %urt!er test#n( to obta#n
a resut ;usuay by 'anua 'et!ods< and to u$7date t!e test#n( record ;data entry
and .er#%#cat#on<5
'%-&*&#I)A* T%'T F&- '/(3I*I'
A un#ts o% bood 'ust be tested by an acce$tabe seroo(#ca test %or sy$!##s ;STS<5
1or %urt!er (u#dance, re%er to CBERGs Dece'ber />, /EE/ 'e'orandu' to
re(#stered bood estab#s!'ents on DCar#%#cat#on o% 1DA Reco''endat#ons %or
Donor De%erra M Product D#str#but#on Based on t!e Resuts o% Sy$!##s Test#n(D5
DI'%A'% .A-+%- T%'TIN#
Eac! coect#on o% "!oe bood and bood co'$onents 'ust be tested %or ant#7HIV,
sy$!##s, and HBsA(5 In add#t#on, t!ey s!oud be tested %or ant#7HCV, ant#7HBc, and
ant#7HTLV7I $er reco''endat#ons %ro' 1DA5 Test#n( %or aan#ne a'#notrans%erase
;ALT< "as #'$e'ented as a surro(ate 'ar4er %or .#ra !e$at#t#s5 1DA !as not 'ade
any reco''endat#ons as to "!et!er or not bood ban4s s!oud $er%or' ALT test#n(-
!o"e.er, ALT test#n( !as beco'e an #ndustry standard5 I% an estab#s!'ent !as
#'$e'ented ALT test#n(, t!ey s!oud be %oo"#n( t!e 'anu%acturerGs #nstruct#ons
and t!e#r SOP %or $er%or'#n( t!e test and #nter$ret#n( t!e test resuts5
Eac! un#t o% bood 'ust be tested %or HBsA( by a #censed t!#rd (enerat#on test5
T!#rd (enerat#on tests #ncude rad#o#''unoassay ;RIA<, re.erse $ass#.e
!e'a((ut#nat#on ;RPHA<, or enCy'e7#n4ed #''unosorbent assay ;ELISA or
EIA<5
Re%er to CBERGs Dece'ber >>, /EE?, 'e'orandu' to re(#stered estab#s!'ents
ent#ted DDonor Su#tab##ty Reated to Laboratory Test#n( %or V#ra He$at#t#s and a
H#story o% V#ra He$at#t#sD5
Eac! un#t 'ust be tested %or ant#body to HIV "#t! a #censed test 4#t5 T!ere are t!ree
ty$es o% #censed 4#ts based u$on d#%%erent 'anu%actur#n( tec!noo(#es:
3!oe .#ra ysates-
Reco'b#nant DNA tec!noo(y- ;See t!e 1ebruary / and Au(ust /, EHE, 'e'oranda
D9se o% t!e Reco'b#(en HIV7/ LA TestD %or %urt!er #n%or'at#on5< and,
Synt!et#c $e$t#des5
Re%er to Co'$#ance Pro(ra' 2?&>500/, Ins$ect#on o% L#cense and 9n#censed
Bood Ban4s, Attac!'ents C and D, %or a #st o% #censed test 4#ts %or HBsA(, ant#7
HIV7/, ant#7HIV7>, ant#7HIV7/8>, Ant#7HCV, Ant#7Hbc, Ant#7HTLV7I, and 3estern
bot5
T%'TIN# (%-F&-.%D &N (-%.I'%'
Re%er to t!e %oo"#n( 'e'oranda %or %urt!er #n%or'at#on:
/5 DReco''endat#ons %or t!e 6ana(e'ent o% Donors and 9n#ts t!at are In#t#ay
React#.e %or He$at#t#s B Sur%ace Ant#(en ;HBsA(<D dated Dece'ber >, EH2
>5 DHTLV7I Ant#body Test#n(D, dated No.e'ber >E, /EHH
?5 DRe.#sed Reco''endat#ons %or t!e Pre.ent#on o% HIV Trans'#ss#on by Bood
and Bood ProductsD, dated A$r# >?, /EE>
&5 D9se o% 1uoro(nost HIV7/ I''uno%uorescent Assay ;I1A<D, dated A$r# >?,
/EE>
)5 DRe.#s#on to >+ October /EHE Gu#de#ne %or Coect#on o% Bood or Bood
Products %ro' Donors "#t! Pos#t#.e Tests %or In%ect#ous D#sease 6ar4ers ;GH#(!
R#s4G Donors<D, dated A$r# /2, /EE/
+5 D1DA Reco''endat#ons Concern#n( Test#n( %or Ant#body to He$at#t#s B Core
Ant#(en ;Ant#7HBc<D, dated Se$te'ber /0, /EE/
25 DRe.#sed Reco''endat#ons %or Test#n( 3!oe Bood, Bood Co'$onents,
Source Pas'a and Source Leu4ocytes %or Ant#body to He$at#t#s C V#rus Encoded
Ant#(en ;Ant#7HCV<D, dated Au(ust ), /EE?
H5 DD#s$os#t#on o% Bood Products Intended %or Autoo(ous 9se T!at Test
Re$eatedy React#.e %or Ant#7HCVD, dated Se$te'ber //, /EE/
I% auto'ated test#n( e*u#$'ent #s #nter%aced "#t! a co'$uter syste' see sect#on on
co'$uter#Cat#on, %or %urt!er (u#dance5
In t!e $ast, t!e area used %or HBsA( and ant#7HIV test#n( "oud, by des#(n, be #n
roo's se$arated %ro' ot!er bood ban4 act#.#t#es5 T!#s #s no on(er cons#dered to be
#'$ortant as a bood sa'$es s!oud be treated as ca$abe o% trans'#tt#n( an
#n%ect#ous d#sease, and B#osa%ety Le.e > $recaut#ons s!oud be a$$#ed #n a areas
"!ere o$en sa'$es are !anded5 Ho"e.er, #% RIA $rocedures are used #n t!e %ac##ty
t!ese areas st# 'ust be $!ys#cay se$arated %ro' ot!er areas5 3or4 areas, suc! as
counter to$s, s!oud be constructed o% non7$orous 'ater#as and des#(ned to $er'#t
t!orou(! cean#n( and d#s#n%ect#on5 T!ere s!oud be $o#c#es to $re.ent e,cess#.e
tra%%#c o% unaut!or#Ced $ersonne t!rou(! .#ra test#n( areas5
(-&FI)I%N)/ T%'TIN#
6ost bood estab#s!'ents "# be $art#c#$at#n( #n a $ro%#c#ency test#n( $ro(ra',
e#t!er an #n7!ouse de.eo$ed or an estab#s!ed $ro(ra' suc! as t!e Coe(e o%
A'er#can Pat!oo(#sts ;CAP<, AABB or CDC5
A $ro$osed rue "as $ub#s!ed #n t!e Aune +, /EHE, 1edera Re(#ster to re*u#re t!at
eac! estab#s!'ent or aboratory res$ons#be %or $er%or'#n( 1DA re*u#red tests %or
HBsA( and ant#7 HIV $art#c#$ate #n an a$$ro.ed $ro(ra' to de'onstrate
$ro%#c#ency #n $er%or'#n( t!ese tests5 T!e %#na re(uat#on $ro$osed by 1DA !as not
been $ub#s!ed, !o"e.er, t!e %#na rue $ro$osed by HC1A, "!#c! re(uates
aborator#es rece#.#n( 6ed#care and 6ed#ca#d re#'burse'ent, "as $ub#s!ed #n t!e
6arc! /&, /EE0, 1edera Re(#ster5 T!#s %#na rue re*u#res aborator#es to !a.e
$o#c#es and $rocedures %or an on(o#n( $ro(ra' to assure t!at e'$oyees are
co'$etent and 'a#nta#n t!e#r co'$etency to $er%or' t!e#r dut#es5
T%'TIN# (%-F&-.%D B/ &$T'ID% *AB&-AT&-I%'
T!e resuts and #nter$retat#ons o% a ;#n#t#a and re$eat< tests $er%or'ed and an
e,$anat#on o% any sy'bos or $!rases used #n re$ort#n( resuts s!oud be $ro.#ded
by t!e test#n( %ac##ty to t!e bood ban45 T!e bood ban4 s!oud !a.e an SOP %or t!e
#nter$retat#on o% t!e re$orts obta#ned %ro' outs#de test#n( aborator#es and "r#tten
assurance t!at t!e outs#de test#n( aboratory #nter$rets test resuts accord#n( to 1DA
re*u#re'ents5 T!e ra" test data, #5e5, absorbance read#n(s %ro' t!e
s$ectro$!oto'eter, need not be sent to t!e bood ban45 In add#t#on, #% t!e bood
estab#s!'ent #s re7enter#n( donors "#t! $re.#ousy re$eatedy react#.e ant#7HIV test
resuts, t!e estab#s!'ent 'ust deter'#ne #% t!e outs#de test#n( aboratory #s
$er%or'#n( 3estern bot assays "#t! #censed test 4#ts5
At t!#s t#'e, >/ C1R +025+);(< e,e'$ts %ro' t!e re*u#re'ent to re(#ster c#n#ca
aborator#es t!at are a$$ro.ed %or 6ed#care re#'burse'ent $er%or'#n( !e$at#t#s and
ant#7HIV test#n( on donor bood %or ot!er re(#stered %ac##t#es5 I% not re(#stered, t!e
test#n( aboratory s!oud be as4ed to .ountar#y re(#ster5 Send t!e test#n( aboratory
1or' 1DA7>H?0, Bood Estab#s!'ent Re(#strat#on and Product L#st#n(, #n
accordance "#t! t!e $rocedures descr#bed #n 1#ed 6ana(e'ent D#rect#.e E>5
L#censed bood estab#s!'ents 'ay !a.e .#ra test#n( $er%or'ed at test#n( %ac##t#es
"!#c! are aso #censed, and ony "#t! CBER a$$ro.a5
E,ce$t %or e'er(enc#es, no un#ts s!oud be #ssued unt# "r#tten !e$at#t#s and HIV
ant#body test resuts are #n t!e $ossess#on o% t!e bood ban45
$'% &F -%A)TI5% $NIT'
Re%er to t!e %oo"#n( 'e'oranda:
/5 DGu#de#ne %or Coect#on o% Bood or Bood Products %ro' Donors "#t! Pos#t#.e
Tests %or In%ect#ous D#sease 6ar4ers ;DH#(! R#s4D Donors<D, dated October >+, EHE5
>5 Re.#s#on to >+ October /EHE Gu#de#ne %or Coect#on o% Bood or Bood Products
%ro' Donors "#t! Pos#t#.e Tests %or In%ect#ous D#sease 6ar4ers ;GH#(! R#s4G
Donors<D, dated A$r# /2, /EE/5
?5 DD#s$os#t#on o% Bood Products Intended %or Autoo(ous 9se T!at are Re$eatedy
React#.e %or Ant#7HCVD, dated Se$te'ber //, /EE/5
IN5A*IDATI&N &F T%'T -%'$*T'
Re%er to CBERGs Aanuary ?, /EE& 'e'orandu', t#ted DReco''endat#ons %or t!e
In.a#dat#on o% Test Resuts 3!en 9s#n( L#censed V#ra 6ar4er Assays to Screen
DonorsD5
T!ese reco''endat#ons car#%y 1DAGs $os#t#on on t!e #n.a#dat#on o% test resuts
"!en screen#n( donor bood us#n( #censed .#ra 'ar4er assays, #ncud#n( t!e use o%
e,terna contro rea(ents5
(A-T ) 2 -%D B*&&D )%**'
&(%N '/'T%.
Bood co'$onents %or trans%us#on are nor'ay $re$ared #n a cosed, ster#e syste'5
Occas#onay, !o"e.er, t!e !er'et#c sea 'ay be bro4en, t!ereby e,$os#n( t!e bood
co'$onent to t!e outs#de en.#ron'ent5 3!en t!#s occurs t!e co'$onent s!oud !a.e
an e,$#rat#on date not to e,ceed >& !ours5
ADDITI5% '&*$TI&N'
6anu%acturers o% certa#n bood coect#on syste's !a.e been a$$ro.ed %or a roo'
te'$erature e#(!t !our !od $er#od %oo"#n( t!e coect#on o% "!oe bood $r#or to
$re$arat#on o% co'$onents5 T!ese syste's are t!e ADSOLR sout#on syste'
;ant#coa(uant CPD<, 'anu%actured by 1en"a Laborator#es, D#.#s#on o% Ba,ter
Heat!care Cor$orat#on, t!e Nutr#ceR syste' ;ant#coa(uant CP>D<, 'anu%actured
by Cutter B#oo(#ca, D#.#s#on o% 6#es Inc5, and O$t#soR, 'anu%actured by Teru'o
Cor$orat#on5 In add#t#on, 1en"aGs coect#on syste' conta#n#n( CPDA7/ #s aso
a$$ro.ed %or an e#(!t !our !od $r#or to co'$onent $re$arat#on5 Pateets, 1res!
1roCen Pas'a, Cryo$rec#$#tated AH1 and Reco.ered Pas'a 'ay be $re$ared %ro'
t!e "!oe bood "#t!#n e#(!t !ours o% coect#on5
I% 1res! 1roCen Pas'a, Pateets, or Cryo$rec#$#tated AH1 are not $re$ared %ro'
t!e un#ts o% "!oe bood, t!e add#t#.e sout#on 'ay be added to t!e red bood ces
;RBCGs< "#t!#n t!ree days o% coect#on5
-%D B*&&D )%**' F-&6%N AND -%D B*&&D )%**'
D%#*/)%-&*I6%D
T!e %reeC#n( o% RBCGs 'ay be acco'$#s!ed by t"o acce$tabe tec!n#*ues, e5(5,
!#(! concentrat#on (ycero7so" %reeCe ;stora(e at NI 7+)oC< and o" concentrat#on
(ycero7ra$#d %reeCe ;stora(e, usuay #n #*u#d N>, at NI 7/>0oC<5 T!e ot nu'bers
o% sout#ons and conta#ners %or (ycero#Cat#on and de(ycero#Cat#on 'ust be
recorded5 Red Bood Ces, 1roCen 'ay be stored %or ten years5 I% un#ts #n stora(e
!a.e not been tested %or a currenty re*u#red tests, t!ere s!oud be a $rocedure to
$re.ent '#sabe#n( "!en un#ts are t!a"ed5
@ua#ty contro test#n( s!oud be $er%or'ed and t!e %#r' s!oud ta4e correct#.e
act#on "!en test resuts are out o% t!e %#r'Gs estab#s!ed $ara'eters as stated #n t!e
SOPGs5 @ua#ty contro test#n( 'ay #ncude $er#od#c ster##ty test#n(, 'on#tor#n( t!e
re'o.a o% t!e (ycero and t!e a'ount o% t!e %ree !e'o(ob#n #n t!e %#na $roduct,
and t!e RBC reco.ery5 Certa#n bood centers !a.e a$$ro.a %or an SOP t!at does not
re*u#re ster##ty c!ec4s on Red Bood Ces, De(ycero#Ced, on a $er#od#c bas#s #%
t!e %ac##t#es "!ere t!e $roduct #s $re$ared are 'on#tored %or cean#ness and (ood
!ouse4ee$#n( $rocedures, #ncud#n( $ro$er 'a#ntenance o% a#r %#ters #n t!e !eat#n(,
.ent#at#on and a#r cond#t#on#n( ;HVAC< syste'5
An area o% concern #s t!at t!e %#r' !as ade*uate $rocedures to assure t!at t!e %#na
conta#ner #s accuratey #dent#%#ed to reate #t to t!e donor5 1or e,a'$e, #% se.era
un#ts o% bood are %roCen and de(ycero#Ced s#'utaneousy, "!at contros does t!e
%#r' ut##Ce to assure a(a#nst '#,7u$sO ABO and R! c!ec4s s!oud be $er%or'ed
a%ter a un#t #s de(ycero#Ced to .er#%y t!e bood ty$e5
-%7$5%NATIN# '&*$TI&N'
So'e estab#s!'ents use reFu.enat#n( sout#ons ;ReFu.asoR, Cytoso Labs, Red
Bood Ce Process#n( Sout#on "!#c! conta#ns $yru.ate, #nos#ne, $!os$!ate and
aden#ne< to restore nor'a c!aracter#st#cs o% o,y(en trans$ort and de#.ery and
#'$ro.e $ost7trans%us#on sur.#.a o% RBCGs5 T!ese sout#ons s!oud be used
ase$t#cay and accord#n( to t!e 'anu%acturerGs #nstruct#ons5 ReFu.asoR 'ay be
used to reFu.enate RBCGs "!#c! !a.e been e,$#red %or u$ to t!ree days5 Once t!e
reFu.enat#n( sout#on #s added to t!e red bood ces t!e un#t 'ay be "as!ed and
trans%used as Red Bood Ces, ReFu.enated, or t!e red bood ces 'ay be %roCen
and de(ycero#Ced ;abeed res$ect#.ey as Red Bood Ces 1roCen, ReFu.enated,
and Red Bood Ces, ReFu.enated, De(ycero#Ced<5
-%D B*&&D )%**' 2 *%$+&)/T%' -%.&5%D
T!ere are se.era 'et!ods %or re'o.#n( eu4ocytes %ro' RBCGs5 T!ese 'et!ods
#ncude centr#%u(at#on "#t! or "#t!out sa#ne "as!#n(, '#croa((re(ate bood
%#trat#on, %reeC#n( and de(ycero#C#n(, "as!#n( ;us#n( e#t!er a 'anua or auto'ated
'et!od< and %#trat#on "#t! %#ters des#(ned and a$$ro.ed s$ec#%#cay %or eu4ocyte
re'o.a5
1or un#ts abeed DLeu4ocytes Re'o.edD *ua#ty contro ;@C< s!oud be $er%or'ed
%or a t!e 'et!ods #sted abo.e5 T!#s 'ont!y @C #s not necessary #%: ;/< t!e un#t #s
not abeed DLeu4ocytes Re'o.edD- or ;>< t!e eu4ocytes are re'o.ed as t!e un#t #s
be#n( trans%used us#n( a %#ter t!at #s connected to t!e trans%us#on set by t!e
'anu%acturer or at t!e $at#entGs beds#de5 T!e bood ban4 s!oud !a.e SOPGs stat#n(
.aues o% acce$tance %or eu4ocyte re'o.a and correct#.e act#on to be ta4en #%
.aues are outs#de estab#s!ed #'#ts5 1#ters s$ec#%#c %or eu4ocyte re'o.a are
so'et#'es connected to t!e trans%us#on set at t!e $at#entGs beds#de and #t "oud not
be $ract#ca to 'on#tor t!e $ost7 %#trat#on bood %or eu4ocyte counts5 T!e *ua#ty
contro %or t!ese %#ters "as $er%or'ed by t!e 'anu%acturer as $art o% t!e a$$ro.a
$rocess5 Trans%us#on ser.#ces t!at use %#ters t!at re'o.e eu4ocytes dur#n(
trans%us#on are not cons#dered to be 'anu%actur#n( a bood $roduct5
I--ADIAT%D B*&&D
E,$er#'enta data !a.e estab#s!ed t!at #n certa#n #''unode$ressed $at#ents
trans%us#on o% %ore#(n #''unoco'$etent ces ;T y'$!ocytes< 'ay ead to (ra%t
.ersus !ost d#sease ;GVHD<5 GVHD occurs "!en donor T y'$!ocytes en(ra%t,
'ut#$y and react a(a#nst t!e t#ssues o% t!e rec#$#ent5 T!e rad#osens#t#.#ty o% t!ese T
y'$!ocytes #s !#(!er t!an t!at o% ot!er bood ces, so #rrad#at#on o% ceuar bood
$roducts be%ore rrans%us#on a$$ears to be e%%ect#.e #n $re.ent#n( t!e trans%us#on
#nduced %or' o% t!#s ser#ous co'$#cat#on5 T!e AABB !as recenty reco''ended
t!at bood co'$onents $re$ared %ro' d#rected bood donat#ons %ro' %#rst de(ree
%a'#y 'e'bers ;#5e5, $arents, c!#dren, s#b#n(s< be #rrad#ated to decrease t!e r#s4 o%
GVHD5 T!e CBER #ssued (u#dance .#a a Auy 2, /EE?, 'e'orandu' t#ted
DReco''endat#ons Re(ard#n( L#cense A'end'ents and Procedures %or Ga''a
Irrad#at#on o% Bood ProductsD5 T!#s docu'ent addresses 'anu%actur#n( and *ua#ty
assurance $rocedures, abe#n(, ot!er as$ects o% $roduct#on and t!e use o% #rrad#ated
bood and bood $roducts5 It aso $ro.#des bac4(round on t!e e%%ects o% (a''a
rad#at#on on $roduct *ua#ty M stab##ty, (u#dance on #cense a'end'ents, record
4ee$#n( and %ata#ty re$ort#n(5 I% any *uest#onabe $rocedures %or #rrad#at#n( bood
are encountered dur#n( an #ns$ect#on not#%y t!e D#.#s#on o% Ins$ect#ons and
Sur.e#ance, ;?0/< )E&7//E/5
-%D B*&&D )%**' 2 -%)&-D'
Bood ban4s t!at $re$are "as!ed, %roCen, de(ycero#Ced and reFu.enated RBCGs
'ust record t!e ot nu'bers o% sout#ons and8or conta#ners5 T!e ot nu'bers 'ust be
traceabe to t!e un#t nu'ber5
-%D B*&&D )%**' 2 I..$NI6ATI&N (-&#-A.'
Re%er to CBERGs Dece'ber /+, /EE> 'e'orandu' on t!e DRe.#s#on o% October 2,
/EHH, 6e'orandu' Concern#n( Red Bood Ce I''un#Cat#on Pro(ra'sD5 T!#s
docu'ent #ncor$orates a /> 'ont! de%erra %or donors and rec#$#ents o% RBCs %or
#''un#Cat#on as $art o% Source Pas'a $ro(ra's5 It aso $ro.#des add#t#ona
#n%or'at#on on %roCen stora(e, seect#on o% sa%e donors and #cense a'end'ents5
(A-T D 2 (*A'.A AND -%)&5%-%D (*A'.A
Eac! %#na conta#ner o% $as'a %or trans%us#on $re$ared %ro' a "!oe bood
coect#on s!a be #n an #nte(ray attac!ed sate#te ba( at t!e t#'e o% coect#on- #t
'ust be trans$arent and !er'et#cay seaed by a d#eectr#c seaer, 'eta ca'$, or
t#(!ty dra"n D"!#te 4not-D and #ts abe 'ust be 'ar4ed by nu'ber or ot!er sy'bo
so t!at #t can be traced bac4 to t!e donor5
(*A'.A (-&D$)T' F&- T-AN'F$'I&N
T!e %#na $roduct s!oud be stored #n a 'anner "!#c! "# s!o" e.#dence o%
t!a"#n(5 T!#s 'ay be acco'$#s!ed #n a .ar#ety o% "ays, e5(5, by stor#n( #t u$s#de
do"n a%ter %reeC#n(, or by $ac#n( a rubber band around t!e '#dde o% t!e conta#ner
and re'o.#n( #t "!en t!e un#t !as %roCen5
-%)&5%-%D (*A'.A
Reco.ered Pas'a #s an un#censed source 'ater#a #ntended %or use #n t!e
'anu%acture o% bot! #censed and un#censed $roducts5 A #cense #s not re*u#red to
'anu%acture, d#str#bute, or $oo reco.ered $as'a5
T!e s!ort su$$y $ro.#s#on ao"s #censed 'anu%acturers to use un#censed or ot!er
#censed %ac##t#es, not a $art o% t!e#r o"n estab#s!'ent, to $er%or' t!e #n#t#a and
$art#a 'anu%actur#n( ste$ o% coect#n( bood or $as'a5 T!e Reco.ered Pas'a #s
s!#$$ed soey to t!e #censee %or %urt!er 'anu%acture #nto #censed #nFectabe or
non#nFectabe $roducts5 S!ort su$$y a(ree'ents are bet"een t!e #censed
%ract#onator and t!e coect#on %ac##ty- not "#t! bro4ers5 T!e "r#tten a(ree'ents
s!oud be u$7 dated $er#od#cay, and a co$y o% t!#s a(ree'ent s!oud be on %#e at
t!e coect#n( %ac##ty5 Pas'a bro4ers 'ay be used as aut!or#Ced a(ents and s!oud
be #dent#%#ed #n t!e s!ort su$$y a(ree'ent- re%er t!e na'e o% t!e bro4er ta4#n(
$ossess#on o% t!e Reco.ered Pas'a or ot!er bood co'$onents to t!e !o'e d#str#ct
%or %oo"7u$, #5e5, re(#strat#on and #ns$ect#on5 S!ort su$$y a(ree'ents are aso
re*u#red bet"een t!e re(#stered coect#on %ac##ty and t!e #censed 'anu%acturer %or
ot!er bood co'$onents ;#5e5, RBCGs and $ateets< #ntended %or %urt!er 'anu%acture
#nto #censed $roducts5
Reco.ered Pas'a does not !a.e an e,$#rat#on date, t!ere%ore, records are to be 4e$t
#nde%#n#tey5
(A-T % 2 (*AT%*%T'
Due to an #ncrease #n t!e nu'ber o% $ost7trans%us#on se$s#s re$orts, t!e se.en day
dat#n( $er#od %or $ateets re.erted to %#.e days, e%%ect#.e Auy >, /EH+5
Pateets 'ay be $ooed by t!e bood ban4 $ersonne, u$on t!e re*uest o% a
$!ys#c#an- !o"e.er, t!#s #s done %oo"#n( des#(nat#on o% t!e $ateets to a s$ec#%#c
rec#$#ent, and t!e resutant $oo #s not cons#dered a #censed $roduct5 T!e abe o% t!e
$ooed co'$onents s!oud #nd#cate t!e #nd#.#dua donor nu'bers co'$r#s#n( t!e
$oo or a $oo nu'ber t!at reates #t to #nd#.#dua donor nu'bers co'$r#s#n( t!e
$oo5 1#na conta#ners 'ust be trans$arent and !er'et#cay seaed by a d#eectr#c
seaer, 'eta ca'$, or t#(!ty dra"n D"!#te 4not5D T!e e,$#rat#on t#'e %or $ooed
$ateets #s #'#ted to & !ours5 9nt# data are a.a#abe #nd#cat#n( t!e e%%ect#.eness o%
t!e $ateets #s 'a#nta#ned %or a on(er $er#od o% t#'e and CBER a$$ro.a #s
obta#ned, t!e e,$#rat#on t#'e o% Pateets "!#c! are $ooed "#t! t!e a#d o% a ster#e
connect#n( de.#ce #s aso #'#ted to %our !ours5
0$A*IT/ )&NT-&*
@ua#ty contro test#n( 'ust be $er%or'ed eac! 'ont! $ateets are $re$ared, us#n(
one un#t obta#ned %ro' eac! o% %our d#%%erent donors5 Pateet counts ;)5) , /0/0 #n
2)P o% t!e un#ts tested<, P! deter'#nat#on ;KI +50< and 'easure'ent o% $as'a
.ou'e s!oud be 'ade at t!e end o% t!e stora(e8dat#n( $er#od5
I% *ua#ty contro test#n( #s not under t!e su$er.#s#on and contro o% t!e
estab#s!'ent, deter'#ne "!ere t!e test#n( #s $er%or'ed and !o" test resuts are
re.#e"ed and !anded by t!e estab#s!'ent5
(A-T F 2 )-/&(-%)I(ITAT%D A3F !ANTI3%.&(3I*I) FA)T&-"
T!ere #s no .ou'e restr#ct#on %or $re$ar#n( Cryo$rec#$#tated AH15 One un#t o%
$as'a 'ay be used as a source o% bot! Pateets and Cryo$rec#$#tated AH15
Pract#ca e,$er#ence !as de'onstrated t!at us#n( care%u $roduct#on tec!n#*ues, an
acce$tabe %#na $roduct a.era(#n( no ess t!an H0 I9 can be 'anu%actured %ro' a
s#n(e un#t5
As "#t! Pateets, Cryo$rec#$#tated AH1 'ay be $ooed u$on re*uest o% a $!ys#c#an5
T!e abe o% $ooed co'$onents s!oud #nd#cate t!e #nd#.#dua donor nu'bers
co'$r#s#n( t!e $oo or a $oo nu'ber t!at reates t!e $ooed AH1 to t!e #nd#.#dua
donor nu'bers co'$r#s#n( t!e $oo5 T!ere are so'e %#r's 'anu%actur#n(
Cryo$rec#$#tated AH1, Pooed as a #censed $roduct5
1#r's 'ay !a.e a$$ro.a %or .ar#ances under >/ C1R +&05/>0 %ro' t!e re(uat#ons
%or 'anu%actur#n( Cryo$rec#$#tated AH1, #5e5, $re$ar#n( Cryo$rec#$#tated AH1
"#t!#n /) !ours a%ter $!eboto'y5 T!e %#r' s!oud !a.e "r#tten a$$ro.a %ro'
CBER %or any .ar#ance5
T!e %#na conta#ner s!oud be trans$arent and !er'et#cay seaed by a d#eectr#c
seaer, 'eta ca'$, or a t#(!t D"!#te 4not5D
0$A*IT/ )&NT-&*
@ua#ty contro test#n( need be $er%or'ed ony #n t!e 'ont!s #n "!#c! t!e $roduct #s
$re$ared5 1our un#ts 'ust be tested, but t!ey 'ay be $ooed be%ore t!e *ua#ty
contro assay #s $er%or'ed5
I% *ua#ty contro test#n( #s not $er%or'ed under t!e su$er.#s#on o% t!e estab#s!'ent,
see Co'$#ance Po#cy Gu#de 2/?&5/+5
(A-T # 2 $NIF&-. B*&&D *AB%*IN#
It #s su((ested t!at a abe be coected %or ready re%erence #n c!ec4#n( t!e abe
#te's- !o"e.er, #t #s #'$ortant t!at t!e abes on un#ts ready %or #ssue are t!e abes
#n actua use and are $ro$ery co'$eted5 T!e 9n#%or' Labe#n( Gu#de#nes "as
$ub#s!ed Au(ust ?0, /EH), and t!e e%%ect#.e date "as Se$te'ber >, /EH+5 A re.#sed
Gu#de#ne %or 9n#%or' Bood Labe#n( #s e,$ected to be $ub#s!ed #n t!e near %uture5
S$ec#%#c abe #n%or'at#on s!oud de$#ct re%erence to .#ra 'ar4er test#n( resuts and
ot!er tests $er%or'ed, e5(5 ALT5
)I-)$*A-'
T!e c#rcuars are o% (reat #'$ortance no" t!at un#%or' or co''ona#ty abes are #n
use5 T!e ne" abes !a.e ess #n%or'at#on on t!e' so t!at attent#on "# be %ocused
on t!e bood (rou$ ;ABO and R!<5 In%or'at#on t!at !as been deeted 'ust be #n t!e
c#rcuar5 T!e c#rcuar o% #n%or'at#on #s an e,tens#on o% t!e conta#ner abes and
.#e"ed as abe#n( conta#n#n( state'ents o% $ur$orted $roduct *ua#ty5 It s!oud
descr#be eac! co'$onent a.a#abe %or $at#ent trans%us#on and (#.e #nd#cat#ons and
contra#nd#cat#ons %or use5 T!e bood su$$#er s!oud !a.e a $an %or d#str#but#n( t!e
#nstruct#on c#rcuars, assur#n( t!at t!e trans%us#on ser.#ces !a.e an ade*uate su$$y
o% t!e c#rcuars, and t!e trans%us#on ser.#ce s!oud !a.e a $an %or d#str#but#n( t!e
c#rcuars to t!e sta%%5 L#censed bood ban4s "# !a.e sub'#tted t!e#r c#rcuars to
CBER %or a$$ro.a5 T!e %#r'Gs na'e and address s!oud be on t!e c#rcuar5
(A-T 3 2 )&.(ATIBI*IT/ T%'TIN# AND T-AN'F$'I&N -%A)TI&N'
)&.(ATIBI*IT/ T%'TIN#
Co'$at#b##ty test#n( s!oud be $er%or'ed #n an area su%%#c#enty re'o.ed %ro'
ot!er areas to e#'#nate d#stract#on or t!e #ntroduct#on o% errors #n test#n(5
Hos$#tas 'ay eect not to cross'atc! bood %or certa#n sur(#ca $rocedures t!at
usuay do not re*u#re t!e trans%us#on o% bood5 T!#s $rocedure #s re%erred to as Dty$e
and screenD and re*u#res: /< deter'#nat#on o% t!e $at#entGs bood (rou$- >< tests o%
$at#entGs seru' %or une,$ected ant#bod#es- and ?< a.a#ab##ty o% un#ts o% bood #n
case t!e $at#ent does need bood dur#n( t!e o$erat#on5
See t!e Dece'ber /&, EH&, 'e'orandu' to bood estab#s!'ents DE*u#.aent
6et!ods %or Co'$at#b##ty Test#n(5D
In add#t#on, ot!er 'et!ods %or t!e co'$at#b##ty test#n( 'ay aso be a$$ro$r#ate5
T!ese 'et!ods #ncude, but, are not #'#ted to, t!e use o% $at#ent s$ec#'ens oder
t!an &H !ours and t!e use o% $as'a5 E,tended $er#ods o% t#'e ;e5(5, 'ore t!an t!ree
'ont!s< %or !od#n( test sa'$es s!oud be d#scussed "#t! t!e D#.#s#on o%
Ins$ect#ons and Sur.e#ance #% encountered5
ANTIB&D/ T%'TIN#
I% an ant#body screen ;seru' #s tested "#t! rea(ent red ces o% 4no"n ant#(en#c
'a4eu$ to deter'#ne #% t!ere are ant#bod#es #n t!e seru'< "as $er%or'ed on a un#t
by t!e su$$#er, t!e !os$#ta or trans%us#on ser.#ce need not re$eat #t, or $er%or' a
'#nor cross'atc!5
-%)I(I%NT 'A.(*% ID%NTIFI)ATI&N
T!e rec#$#entGs bood sa'$e s!oud be #dent#%#ed by na'e and nu'ber to #nsure
$os#t#.e #dent#%#cat#on5 Donor and rec#$#ent bood sa'$es s!oud be sa.ed %or at
east se.en days a%ter trans%us#on #n case t!ere #s a need %or retest#n(5
%.%-#%N)/ T-AN'F$'I&N'
SOPGs s!oud be a.a#abe to e,$ed#te test#n( %or trans%us#ons #n a #%e t!reaten#n(
e'er(ency5 Docu'entat#on s!oud #ncude s#(nature o% t!e re*uest#n( $!ys#c#an5 I%
cross'atc!es are not co'$eted su%%#c#ent docu'entat#on s!oud be a.a#abe5
)&.(ATIBI*IT/ T%'T -%)&-D'
Records s!oud be 4e$t o% rece#$t o% rec#$#entGs sa'$e and t!e ABO and R! test
resuts- ot nu'bers o% rea(ents used %or test#n(- and rout#ne and e'er(ency
cross'atc!es and d#rect ant#(obu#n test#n( ;#% done<5 T!e .#ta s#(ns o% a rec#$#ent
are not re*u#red to be on %#e at t!e bood ban45
-%)I(I%NT AD5%-'% -%A)TI&N'
T!e bood ban4Gs SOP 'anua s!oud #st and descr#be rec#$#ent react#ons #t
cons#ders to be ad.erse, as "e as t!e $rocedures to be %oo"ed %or !and#n( and
#n.est#(at#n( t!ese react#ons5 Rec#$#ent react#ons usuay not cons#dered ser#ous
#ncude o" %e.er and c!#s o% s!ort durat#on, !#.es, or urt#car#a5 Ser#ous ad.erse
rec#$#ent react#ons usuay #ncude !e'oys#s, bactere'#a, or se$t#ce'#a5
I% t!e bood ban4 acts as a trans%us#on ser.#ce and rece#.es bood %ro' ot!er sources,
errors #n t!e ABO and R! (rou$#n( s!oud be re$orted to t!e su$$#ers5 Procedures
s!oud be estab#s!ed bet"een t!e su$$#ers and users o% bood and bood $roducts
%or 'on#tor#n( rec#$#ent ad.erse react#ons "!#c! occur outs#de t!e su$$y#n(
%ac##ty5 I% t!e su$$#er o% '#sty$ed bood #s a #censed estab#s!'ent, #t #s t!e
res$ons#b##ty o% t!at estab#s!'ent to re$ort any errors to CBER, O%%#ce o%
Co'$#ance5 Re%er to CBERGs 'e'orandu' to #ndustry dated 6arc! >0, /EE/, t#ted
DRes$ons#b##t#es o% Bood Estab#s!'ents Reated to Errors M Acc#dents #n t!e
6anu%acture o% Bood Co'$onentsD5
(A-T I 2 'T&-A#%, DI'T-IB$TI&N
(3/'I)A* 'T&-A#%
Bood $roducts s!oud be stored se$aratey but not necessar#y #n a d#%%erent
re%r#(erator5
@uarant#ne $rocedures are a .ery #'$ortant area #n t!e contro $rocedures to $re.ent
t!e d#str#but#on o% unsu#tabe un#ts5 Se$arate stora(e areas s!oud be 'a#nta#ned %or
untested un#ts, %or un#ts "!#c! are not su#tabe %or use ;un#ts to be retested or
re$eatedy react#.e<, and %or un#ts "!#c! are su#tabe %or d#str#but#on5
9n#ts o% bood #ntended %or autoo(ous use s!oud be stored #n an area se$arate %ro'
un#ts %or ao(ene#c use5
'T&-A#% T%.(%-AT$-% AND -%)&-D'
A re*u#red te'$eratures s!oud be 'a#nta#ned5 1uctuat#ons outs#de stora(e
te'$erature #'#ts 'ust be docu'ented as to t!e $oss#be reason, and any act#on
re*u#red to 'a#nta#n t!e bood or co'$onents at t!e $ro$er stora(e te'$erature 'ust
aso be docu'ented5
T!e $roduct stora(e te'$erature a%ter dra"#n( #s /7+oC uness roo' te'$erature
$ateets are to be $re$ared, #n "!#c! case t!e bood s!oud be !ed at >07>&oC5 I%
t!e bood 'ust be trans$orted %ro' a donor center to t!e $rocess#n( aboratory, #t
'ust be $aced #n te'$orary stora(e !a.#n( su%%#c#ent re%r#(erat#on ca$ac#ty to coo
t!e bood cont#nuousy to"ard a /7+oC ran(e, uness $ateets are to be $re$ared5
Te'$eratures beo" >0oC ;+Ho1< and abo.e >&oC ;2)5>o1< reduce $ateet %unct#on
and sur.#.a5 Roo' te'$erature #s usuay not beo" >0oC5
IN'(%)TI&N
Bood s!oud be .#suay #ns$ected at t!e t#'e o% #ssue %or any abnor'a#ty, suc! as
!e'o(ob#n #n t!e $as'a %ro' red ce ys#s, $ur$e t#n(ed red ces due to bacter#a
conta'#nat#on, or bood cots5
'3I((IN#
1ac##t#es s!oud !a.e $rocedures to s!o" t!at s!#$$#n( conta#ners 'a#nta#n $roducts
at t!e#r a$$ro$r#ate te'$erature5
-%I''$%
Bood ban4s s!oud !a.e "r#tten cr#ter#a %or re#ssu#n( bood t!at #s returned to t!e
bood ban45 Stud#es !a.e s!o"n t!at t!e un#t o% bood s#tt#n( at roo' te'$erature
usuay 'a#nta#ns a te'$erature o% /0oC %or ?0 '#nutes5 Bood t!at !as been #ssued
%or trans%us#on 'ay be re#ssued #% #t #s returned to t!e bood ban4 "#t!#n ?0 '#nutes,
and "as 4e$t at roo' te'$erature or coder "!#e out o% t!e bood ban4Gs contro5
(A-T 7 2 (*AT%*%T', (3%-%'I'
Re%er to t!e October, EHH, 'e'orandu' %ro' CBER to a re(#stered bood
estab#s!'ents DRe.#sed Gu#de#ne %or t!e Coect#on o% Pateets, P!eres#s5D
(A-T + 2 )&.($T%-I6ATI&N
T!#s sect#on "# be used to e.auate 9SERS o% co'$uter syste's, and #t #s not
#ntended %or use #n t!e #ns$ect#on o% so%t"are de.eo$ers5
Re%er to t!e 1DA DDra%t Gu#de#ne %or t!e Va#dat#on o% Bood Estab#s!'ent
Co'$uter Syste's5D T!#s docu'ent %ocuses on co'$uter syste' de%#n#t#ons, test#n(,
'anuas, 'a#ntenance, secur#ty, tra#n#n(, aud#ts, 1DA re%erences and re$ortabe
act#.#t#es to t!e 1DA5 T!e %#na docu'ent "# su$ersede t!e A$r# +, /EHH,
'e'orandu' %ro' CBER to a re(#stered bood estab#s!'ents DReco''endat#ons
%or I'$e'entat#on o% Co'$uter#Cat#on #n Bood Estab#s!'entsD, and t!e
Se$te'ber H, EHE, 'e'orandu' DRe*u#re'ents %or Co'$uter#Cat#on o% Bood
Estab#s!'entsD5
T!e dra%t (u#de#ne s!oud be used as t!e 'a#n (u#dance docu'ent on co'$uter#Ced
syste's %or re(#stered bood estab#s!'ents5 Ho"e.er, t!e docu'ent #s subFect to
c!an(e, as $ub#c co''ents are be#n( coected and e.auated %or #ncor$orat#on #nto
t!e %#na (u#de#ne5 S$ec#%#c re(uat#ons "!#c! are currenty a$$#cabe are >/ C1R
+0+5+0 ;E*u#$'ent<, and >/ C1R >//5+H ;Auto'at#c, 'ec!an#ca, and eectr#ca
e*u#$'ent< %or add#t#ona #n%or'at#on5
I% a bood estab#s!'ent #s de.eo$#n( and d#str#but#n( so%t"are t!at "as or#(#nay
#ntended %or #n7!ouse use, re$ort t!e nu'ber and #dent#ty o% t!e user s#tes5 Bood
estab#s!'ents de.eo$#n( and d#str#but#n( so%t"are %or use #n 'anu%actur#n( bood
and bood co'$onents s!oud be ad.#sed t!at t!ey are a de.#ce 'anu%acturer and be
encoura(ed to re(#ster and #st "#t! t!e Center %or De.#ces and Rad#oo(#ca Heat!5
I% t!e so%t"are #s .endor su$$#ed, #dent#%y t!e de.eo$er and .ers#on5 So%t"are
de.eo$ers ty$#cay s$ec#%y t!e so%t"are by a .ers#on nu'ber5 3!en 'aFor c!an(es
!a.e occurred #n t!e so%t"are, a ne" nu'ber #s ass#(ned5 I% a .ers#on d#%%erent %ro'
t!e or#(#na #s #n use, t!e %ac##ty s!oud !a.e $rocedures to test t!e so%t"are $r#or to
#'$e'entat#on and docu'entat#on t!at t!e test#n( "as $er%or'ed5
A Ds!aredD co'$uter syste' #s a syste' used by bot! t!e bood ban4 and ot!er
sect#ons o% a c#n#ca aboratory or t!e ent#re !os$#ta5 Secur#ty $rocedures s!oud
!a.e been estab#s!ed re(ard#n( #'#t#n( access to con%#dent#a bood ban4
#n%or'at#on, e5(5, donor de%erra records5 In add#t#on, access to bood ban4 data
s!oud be #'#ted so t!at #nad.ertent or unaut!or#Ced c!an(es #n data do not occur5
3!en a dec#s#on #s 'ade re(ard#n( donor su#tab##ty and8or $roduct *ua#ty based
u$on t!e use o% and re#ance on t!e data 'a#nta#ned #n t!e co'$uter syste', t!e
co'$uter syste' #s $er%or'#n( a cr#t#ca %unct#on #n t!e 'anu%acture o% bood and
bood $roducts5 An #n.est#(ator s!oud deter'#ne !o" t!e co'$uter syste' #s used
and re#ed u$on #n cr#t#ca 'anu%actur#n( ste$s be(#nn#n( "#t! t!e donat#on and
cont#nu#n( t!rou(! $roduct reease5
A s!ort descr#$t#on "#t! res$ect to eac! o% t!e areas controed by t!e co'$uter
s!oud be re$orted, e5(5, t!e %#r' de$ends on t!e co'$uter to c!ec4 %or $er'anent
and te'$orary de%erras- u$dates %or t!e de%erra #st are 'a#nta#ned d#recty by t!e
co'$uter "!#c! e.auates a test resuts rece#.ed d#recty %ro' t!e test e*u#$'ent-
a co'$onent $rocess#n( #s $er%or'ed us#n( bar coded abes- *uarant#ne #s
co'$uter controed and #% react#.e test resuts are noted, an auto'at#c %a( #s $ut on
t!e un#t by t!e co'$uter so t!at t!e un#t ;co'$onents #ncuded< cannot be reeased
%or d#str#but#on5
T%-.' AND ABB-%5IATI&N'
Ao(ene#c Donor 7 A donor "!o donates a un#t o% bood to be $aced #n t!e (enera
bood su$$y5 T!#s donor 'ust 'eet a su#tab##ty re*u#re'ents and be %uy tested5
Ant#7A, Ant#7B Bood Grou$#n( Rea(ent 7 Rea(ents used to deter'#ne bood (rou$:
Ant#7A seru', %ro' a (rou$ B #nd#.#dua, "# a((ut#nate or cu'$ (rou$ A red
ces- Ant#7B seru', %ro' a (rou$ A #nd#.#dua, "# a((ut#nate or cu'$ (rou$ B
red ces5
Ant#7D Bood Grou$#n( Rea(ent 7 Rea(ent used to deter'#ne R!o;D< %actor5 Seru'
%ro' an R! ne(at#.e #nd#.#dua "!o !as been e,$osed to t!e D ant#(en by
trans%us#on or $re(nancy and !as %or'ed t!e ant#body to t!e D ant#(en, or
'onocona ant#bod#es "!#c! are $re$ared by !ybr#do'a tec!n#*ues5
Ant#body Screen 7 Donor or $at#ent seru' #s tested "#t! rea(ent red ces o% 4no"n
ant#(en#c 'a4eu$- t!e $ur$ose #s to deter'#ne #% t!e donor or $at#ent !as ant#bod#es
#n !#s or !er seru'5
Autoo(ous Donor 7 A donor "!o donates a un#t o% bood ;$rede$os#t< %or !#s8!er
o"n use5
B#osa%ety Le.e > 7 Centers %or D#sease Contro and Nat#ona Inst#tutes o% Heat!,
De$art'ent o% Heat! and Hu'an Ser.#ces, $ub#s!ed a boo4et ent#ted B#osa%ety #n
6#crob#oo(#ca and B#o'ed#ca Laborator#es "!#c! reco''ends $recaut#ons "!#c!
aboratory e'$oyees s!oud %oo"5 T!e boo4et #s a.a#abe t!rou(! DHHS
$ub#cat#on No5 ;CDC< HH7H?E), E&7E), >nd Ed#t#on, 3as!#n(ton, DC: 9S
Go.ern'ent Pr#nt#n( O%%#ce, EHH5 A co$y o% t!e c!a$ter concern#n( b#osa%ety e.e
> $recaut#ons can aso be obta#ned %ro' IMSS, ;?0/< >E)7H/E/5 In add#t#on, t!e
AABB Tec!n#ca 6anua su''ar#Ces B#osa%ety Le.e > $recaut#ons5
Cryo$rec#$#tated AH1 ;Ant#!e'o$!##c 1actor< 7 t!e cod7#nsoube $ort#on o%
$as'a re'a#n#n( a%ter 11P !as been t!a"ed bet"een /o and +oC5 Cryo$rec#$#tated
AH1 ;Cryo< #s used to treat $at#ents "#t! !e'o$!##a A, .on 3##brandGs d#sease
and !y$o%#br#no(ene'#a5 Cryo conta#ns %#br#no(en and 1actor VIII, a $rocoa(uant
$resent #n nor'a $as'a but de%#c#ent #n t!e $as'a o% $at#ents "#t! !e'o$!##a A5
D#rected Donor 7 A donor "!o donates a un#t o% bood %or a s$ec#%#c $at#ent5 T!ese
donors s!oud 'eet a su#tab##ty re*u#re'ents and be tested as ao(ene#c donors5
Occas#onay, a d#rected donat#on 'ay not 'eet a su#tab##ty and test#n(
re*u#re'ents, #n "!#c! case, t!e $at#entGs $!ys#c#an 'ay 'a4e a 'ed#ca dec#s#on to
use t!e d#rected donat#on5
Du 7 A .ar#ant or "ea4 %or' o% t!e D ant#(en- no Ant#7Du rea(ent e,#sts, but ces
are tested %or t!e .ar#ant by an #nd#rect ant#(obu#n 'et!od, or t!e e*u#.aent, suc!
as a s$ec#a c!anne on t!e Bontron Grou$a'at#c, Oy'$us PB200, or Ga''a STS7
6 auto'ated bood (rou$ers5
ELISA Screen#n( Test 7 ELISA ;aso re%erred to as EIA< #s an acrony' %or enCy'e7
#n4ed #''unosorbent assay5 T!#s assay ut##Ces t!e $r#nc#$e o% a so#d $!ase, e5(5,
beads or '#crot#ter $ate "es, coated "#t! ant#(en or ant#body and an #nd#cator
rea(ent, ant#body or ant#(en, res$ect#.ey, to "!#c! an enCy'e !as been conFu(ated
or D#n4ed5D
A ty$#ca ELISA test suc! as t!at used %or t!e detect#on o% ant#body to HIV ut##Ces
beads or '#crot#ter "es coated "#t! d#sru$ted, #nact#.ated HIV a(ents and (oat
ant#7!u'an I( conFu(ated or D#n4edD to an enCy'e, "!#c! on #ncubat#on "#t! t!e
a$$ro$r#ate substance, "# $roduce a coor5
3!en an un4no"n seru' or $as'a sa'$e #s tested %or t!e $resence o% ant#bod#es,
#t #s $aced #n t!e ant#(en coated "es, t!e ant#body #n t!e sa'$e #n4s to t!e
ant#(en on t!e so#d7$!ase carr#er and #s detected by t!e ant#7!u'an ant#bod#es
conFu(ated to t!e enCy'e5 Poss#be resuts #ncude:
In#t#ay react#.e 7 In#t#a EIA test #s react#.e5
Re$eatedy react#.e 7 One or bot! du$#cate EIA retests #s8are react#.e5
Ne(at#.e 7 In#t#a EIA test #s non7react#.e or #% react#.e, bot! re$eat du$#cate EIAGs
are nonreact#.e5
Pos#t#.e 7 Re$eatedy react#.e EIA test, 3estern Bot ;3B< $os#t#.e5
3B #ndeter'#nate 7 3estern bot ne#t!er $os#t#.e nor ne(at#.e5
EIA #ndeter'#nate 7 Re$eatedy react#.e EIA test, 3estern bot ne(at#.e or
#ndeter'#nate5
He'atocr#t 7 T!e $ercenta(e o% red bood ces $resent #n t!e "!oe bood .ou'e5
He'o(ob#n 7 T!e 'a#n co'$onent o% t!e red bood ce 7 an #ron conta#n#n( $rote#n
"!#c! ser.es as t!e .e!#ce %or t!e trans$ortat#on o% o,y(en and carbon d#o,#de5
6aFor Cross'atc! 7 Pat#entGs seru' tested "#t! donorGs red ces- t!e $ur$ose #s to
deter'#ne #% t!e $at#ent !as an ant#body to an ant#(en %ound on t!e donorGs ces5
6#nor Cross'atc! 7 DonorGs seru' tested "#t! $at#entGs red ces- t!e $ur$ose #s to
deter'#ne #% t!e donor !as an ant#body to an ant#(en %ound on t!e $at#entGs ces5
Pas'a 7 Se$arated %ro' red bood ces "#t!#n >+ days a%ter $!eboto'y ;"#t!#n &0
days a%ter $!eboto'y "!en CPDA7/ sout#on #s used as t!e ant#coa(uant<5 Stored
at 7/HoC or coder "#t!#n s#, !ours a%ter se$arat#on ;see #nstruct#on boo4et<5 Dat#n(
$er#od #s %#.e years5 Pateets and8or Cryo$rec#$#tated AH1 'ay be re'o.ed %ro'
$roduct5
/5 L#*u#d $as'a: Se$arated %ro' red bood ces "#t!#n >+ days a%ter $!eboto'y
;"#t!#n &0 days a%ter $!eboto'y "!en CPDA7/ sout#on #s used as t!e
ant#coa(uant<5 Stored at /7+oC %or a tota o% >+ days ;&0 days "!en CPDA7/ #s
used<5
>5 1res! 1roCen Pas'a: Coected "#t! '#n#'a da'a(e to t#ssues5 Se$arated %ro'
red bood ces and %roCen so#d "#t!#n s#, !ours5 So'e 'anu%acturers !a.e rece#.ed
a$$ro.a %or t!e#r coect#on syste's to ao" roo' te'$erature stora(e be%ore
$as'a se$arat#on to be e,tended to e#(!t !ours ;see #nstruct#on boo4et<5 Stored at
7/HoC or coder %or u$ to one year5
?5 Pateet R#c! Pas'a: Coected "#t! '#n#'a da'a(e to t#ssues5 Se$arated %ro'
red bood ces "#t!#n s#, !ours a%ter $!eboto'y ;see #nstruct#on boo4et<5
Procedure 'ust $roduce a $roduct "#t! at east >)0,000 $ateets8'#cro#ter5 Stored
at /7+oC %or 2> !ours, or at >07>&oC "#t! (ente a(#tat#on %or %#.e days #n a$$ro.ed
conta#ners5
&5 Reco.ered Pas'a: Obta#ned %ro' s#n(e un#ts o% e,$#red or une,$#red "!oe
bood, outdated $as'a, or as a by7$roduct #n bood co'$onent $re$arat#on5 1or
%urt!er 'anu%actur#n( use ony5 6ust be abe to reate $as'a un#t to donor5 Donors
'ust 'eet donor su#tab##ty re*u#re'ents and eac! un#t 'ust be tested %or #n%ect#ous
a(ents, as re*u#red5
Pas'a$!eres#s 7 A $rocess #n "!#c! red bood ces are se$arated %ro' t!e $as'a
o% a bood donor and returned to t!e donorGs c#rcuatory syste'5
Pateet$!eres#s 7 T!e re'o.a o% $ateets %ro' a donor, %oo"ed by t!e return o%
t!e red bood ces and so'et#'es t!e $as'a to t!e donor5
S$ec#%#c (ra.#ty o% "!oe bood 7 /50)? ('8' %or bood conta#n#n( />5) ('8d o%
!e'o(ob#n5 T!e %oo"#n( cacuat#on #s used to con.ert .ou'e to "e#(!t: /50)?
('8' L )00 ' I )>+5) ('5
SOP 7 Standard o$erat#n( $rocedures5
STS 7 Seroo(#ca test %or sy$!##s, e5(5, VDRL, RPR, and t!e tre$one'a7based
!e'a((ut#nat#on test on t!e Oy'$us auto'ated bo
4 t+,- .re-ent#t,on ,- tr2n&#te% e5#&t$1 ,n t+e for" #- .re-ente% 1 FDA on
t+e ,nternet #t +tt.677000.f%#.go37or#7,n-.e&t8ref7,g-7$oo%.+t"$ 9

T+#n! 1o2 for 3,-,t,ng B$oo%Boo!.&o".
Ho'e QQ Pr#.acy QQ S#te S$ecs
Leg#$ : Co.1r,g+t ; <===)<==> B$oo%Boo!.&o". A$$ r,g+t- re-er3e% 0or$%0,%e.
B$oo%Boo!.&o" ,- #n ,n%e.en%ent &o""er&,#$ enter.r,-e #n% "#,nt#,n- no
re$#t,on-+,. 0,t+ #n1 "e%,&#$ or &,3,& ,n-t,t2t,on. If 1o2 +#3e ?2e-t,on- or
&o""ent- #o2t t+,- 0e -,te .$e#-e e)"#,$6 0e"#-ter@$oo%oo!.&o".

ast u$dated //8/08>00& boodboo45co'