Documente Academic
Documente Profesional
Documente Cultură
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Sectio n 1 •.TITLE :
Sectio n 3 . Pl.Jl:i-R0$E
.<:-·.
Section 4 SCOPE :' ; ''>
·.-;_.;
i ,' .
.
. -··
Category A (Hospital-Based) .. · ·
category B •(Hd~~il~FBase'dj' ·
1. All ofth~ aboJe{Ca tegoryB -Non Hospital-Based)
2. Compatibility testing . ··. ·· ·... ·. . . . : ...
3. Preliminary investigatiopqfJrari~fusion reactions
4. Resolution of irii::or:Jipatible{,pr6ssmatphes ·
(
2
'".
c. Certificate of Registration . . .
c.1. · .If Corporation /Foundation Proprietorship I
()wn!;)rship~Certified True Copy of (SEC)
. , $ecurities and Exchange Commission ·
.Begisiration · ·
c.2. •. If Single Proprietorship I Ownership
Certified True Copy of (DTI) Domestic Trade ·
. andJnductry Registration
. - . .
. ,.·
:_.·
~ .
Requirements
'
I
!
I
'
.· . . urn number of staff with their corresponding
. · ·.qualification for each . . category of Blood Banks I Blood
· ····.Centers shall pe Cl~ follows:
B,.TECHNJCAL STAFF·
·Medical Technologists
· T\',10 {2)' RMT in mOrning shift, one (1) RMT in afternoon and
night shift, and one (1) RMT on off-duty.
·s
housed in a well-lighted and
well-v·enfilated area with an adequate supply of water.
ThE:) technica l or
working area shall be exclusively for the
use ofthe blood bank/center and its other related activities.
' .,
.6
"-·· ..
applic~ble, •· .
.-
facilities and equipment and
. ' ' '- .
. s. 3 LicensE! Fee , · ·
a. A non~ref~ndabl~ license fee of six hundred pesos (P600.0 0)
· shaltb.e charged for every accepted application for a new license
. to operate
'-- . a.
---·
'',
bloog bank
.
f blqqd center.. ' ., ' ~
b. A non-retGrictableifee off~ur
hundred .pesos (P400.0 0) shall be .
· charged for every accept~d ?PPiication forrenew al of license.
·:.-.:
c; . 1'1:te licehse tee shall, co.ver tne cost .of inspection and printing of
license • certific<J,tes. and other required ·forms and documer:tts.
Subsequent. or SE!para.te. issuances shall cover other allowable
. fees ar:td charges (e.g: proficiency testing fee, blood service fee,
'etc,), , . · · ·
;~ .
o.:- ..
. - - ·- '•
. .
Section
9. TERMS
. AND
- -
tONDITIONS
---
', -- -:---.' OF-. LICENSING
' .•'
. ;,-,
··· 9:3 '~II'he didmse; as well a; tt1e rigl;ts under the license, is non-
.. transferable; directly
. . ._,._ .. ·,___ - 0r indirectly. ·
__
· ,· '.
8
The. following are procedure~ t6 be· followed when applyi~g. for a license:
. a: A duly acpomplish~d and
notarized Petition/ Application Form
· · (BF!L~BSF (BB/BG)Fon;ri No. 1), or J\pplication for Renewal of .
License (BRL"'B SFi (BB/BC). Forrri No;' 2) together with all tiie .
. requirecl~pppor:ting documents shall be' 1addressed. and submitted
. to the Bu~eau of·
Research ;:tpd Laboratories '(BRL)- Division of
Laboratory:Regulatiori ahd Deve[qpment(DLRD). . . ·
b. Ap~licalionsJo~ ~e~ license maybe submitted anytime.
c. Applicationsfor renewal of license should be submitted within 2
rnoniiis ~rior to the expiration ofthe current license. ·
1 0. 2 D~cprt1~11f Scree11iQg 'and Approval
a. DL~·~ ~crel:lns andjva luate;ti ie documents for completeness
and authent icity ... lf 'complete, application is accepted .and·
I .
approyed: A ciiarge, slip is issued and the applican t pays the
correspon~irig license fee at' the BRL Cashier Section.
b. • Donor Forrns:
: . - -...-: . ' ·.:.. -:.".>.- ' -- ;, ' :_ _:
• :- <
,:....;.:.;..~:;:;;<'.~.:-".:-~,.-.:.<~;;,.;,·:;; •..;,c.,::;;·.:.~:; ..••. ~.-:-· ...•
.. r prov1s1on of Health
Edu · · ion, Pre & Post-Donation
Counselling Services for blood donors
(A0#9 s. 1995 , ChapterVIII, Sec. 28,
.. ltem9) ·
b. ·· Guidelines for referrals of blood donors
for fljrther medical evaluation (AO #9 s. .
. 1995 , Chapter VIII,. Sec. 28, Item 9) ·
c. Blood Distribution and Transport
Guidelines (AO #9s. 1995 , Chapter VIII,
Sec. 28, Item 7)
···Fle~~rds.of BkJod.·Donations
· 6:1 · Dorior Session Record
6.2. l:llciodCollection Record
; _:.: .. ,.
.. ··'·ll : ..
He<concts <::>t E1mel'ge11cy
.· Transport Re<~onjs Issue of Blood
Records of Blood .and Co
mponents Received
· .. from Other Facilities
·.·to. Records of Errors and Ac
cidents
·· ·•. 11. . Summary Re
cords
11 .1 Annual Blood Co
:-.- ··.
llection and Utilization
1 0. 3. 2 ,E:Hernal Qual
ity ~ssessment
. ThE;! BR L sball condllc
ta
ProfiCiency Testing to all yearly External Quality Assessment l
I . ba rik r center who go licerised blood bank I center. A blood
t a sa tis fa ct or y rating
. qu al ity Assurance Citat will
ion Certificate. Superviso be given a
conducted as· necessar ry visits will be
y fo blood bar1ks J cente
th~·External Quality As rs who tailed in
/ ·.=· '. sessment.·.· · ·
Se ct io n 11 ISSUAN
CE <lF LI CE NS E
lmmediatelyaft~r appr()val an
iss ue d dir~c'tly to the d evaluation, license
is
(personally of by mail). He ad of the Blood Bank or his prepared and
· representative
·
Section 12 VALIDITY
~~:LIC~NSE
I Each license. shalL expir
e on its ar1ili\fersar{ date
of the year stated.
. Section 13 TRANSI
TION .PERIOD FOF(.C
ONFIRMATION OF LI
CENSES
M ay 28, 199,8 to Juiy·
confirmation of complia 31;:.19QS sh al l be the transition period fo
nc
Blood Banks /,Blood Ce e to ttie..nei,V licensure requirements of existingr
nters fOIJO:wing th e new
BRLcOLRD .·shall. issue BSF categorization. Th
. ce ntiticates to ex ist e
based on the NVBSP '-B ing
iq()d Se rv ic es Ne tw or k blood service facilities
operation until confirm
O~ffi~. ation of lic"ln.ses I ce Guidelines to continue
. rtificates • of authority
.. to
Section 14 PUBLICAT
ION O F THE LIST OF
CE NT ER S LICENSED BLOOD BA
NKS/
An annual updated .lis
published at le as to nc e .()f libens53d blood banks/ centers shall be
t
ay. ea rjn a newspaper
- ~
of general circulation.
.
15 .1 ln ad di tio t'l 'td
A
Documented blood co .o ,N o. 9 s. 19 95 ,C ha pt er x, Sec. 47
llection fron:r paid. do , Item 1,
th e su pe ry is ip g. ot 'a nors; blood collectio
physici?n; non"perfo n without
. testing; and dispos rmance of the require
al () fb lo od unjt~,to d blood
· cause·- for tbe. cancel unauthorized pe rs on
' . , ... . --· -_ lat[on, revocation or su s sh all be a
. -,,• spension of the licen
·S ec tio n 16 ·A PP EA
- '
- - se. .
LS AND RI:PbRTS
ON VHJLATIONS
· ReportS\b~ ~io]~tio
n.ofHA7719 and these Rules
be addre~~~(:!Jo. ~he·
$e and R~gulations shal
Re.search an d .Labor cretary. of f-l~alth and the Di re ct or of the l
atgries. · Bu re au of
$ecr~tary tMDir~ctor
·
The or
an d tne Natiqrial Bu 6f B R L may request
re au o f Investigation for Police Assistance
l? ol ic ef on th e effective an d/ or . the Philippine
inforcement of RA 77 Natio
Rules ari(j Regqlatio
ns .. 19 and these. Implem nal
_., -: ·::· ., . ::
··· . . enting
~,;
. Section 17 REPE
ALiNG .C LAuse.·
These re~uirements
an
C ha pt er VI Ifo fA dm in d prp(::edures shall supersede Sections
is tra tiv e O rd er No. 26-32,
Orders and<Circulars 9 s, 1995, an dr el at
issuances)nt::onsiste
6f th eD ~p aqrnentThe.. provision ed Bu reau
nt wi th 'this administrative orde s of an y of these
o r modifiedaccordin r are he re by repealed
gly. . .. .. .
\ Section 18 iFF~CTIVI'TY CLAlJSE
. These requirement~·afld
· Transition Period of. . pr oc e; uf es shall
§{.)days.fr om date of, take effect May 28, 1998. A
the trans.ition period . effe
for" confirmation of co ctivity of this order shall be
re qu ir em ent~ a'nd.p(oced mpliance to these lic
.
.. ure. · ensing
- ·. . .
. cAaMEN~li\~oiCII, M~.
.· ....•·· ....· · · ·. ·. :Secr~taiyio MPH, CESO
. . . ... f f-lealth .
·~-"
.
. ... ·
;13 .·.·....
. :··,·_.-,-.
. T ab le 1 - BB I B C
M IN I M U M
BANK I CENTER
CATEGORY A
BLOOD BANK I
~!H!ospital - Bas CENTER CATEGORY B
ed
I. N on -H os pi .t al -
B an k R ef ri ge ra to r B as ed
co nt ro ll ed at 1~6 C: Blood Bank Refrige
w it h te m pe ra tu re rator
recorder, al ar m sy
st em ,& · au to m at ic controlled at 1-6 C
_"f _.·, _- .
vo lt ag e. w it h- te m pe ra tu re
}\ gg lu ti na ti on vi ew : . ·recorder, al ar m sy
er for A B O /R H gr st em , & ·a ut om at ic
ou pi ng . re gu la to r vo lt ag e
(t ub e m et ho d) A gg lu ti na ti on vi ew ·
Blood do na ti on co er for ABO /R H gr
uc h or be d (t ub em et ho d) ou pi ng
:1lrgical in st ru m en · · ·
ts : forceps, scissors Blood do na ti on co
H em og lo bi n pete · uc h or be d
~ination . • . Surgical in st ru m
en ts : forceps, scisso
l. bJCyanmethell}og ·F or H em og lo bi n rs
lobll1. M et ho d: I)eterminatio~
ip ho to m et er /H ei · ·· .
n o cu e · 1. by Cyar\J:rlethem
b y C op pe r S ul fa te ·. S pe ct ro ph ot om et oglobfu M et ho d: .
M et ho d er ·/ I-lem&cue i ·
· 2. 9Y C op pe r Sulf
ate_Method ···
l'y cn om et er .·.
L ab or at or y O ve n • · · . . · ·.·.·••· .
(fqr In st ru m en t •D .
ry in g Pu rp os es )
Sphygmomanon:\e
ter
St et ho sc op e
T he rm om et er s·
- · · Room Thermom
eter- ·
··..: "''•• L ab or at or y T he rm
om et er
Clinical T he rm om
Weighing Scales et er
for Blood D on or s
~J:!;ilergency G en er for Blood U ni ts
at or po w er un it (a Autoclave.
~l\1icroplate Ti:ay t least 20 KVA)
V ie w er for .PA M et ho E m er ge nc y G en er
_Clinical ce nt ri fu ge d at or po w er un it (a
M ic ro pl at e T ra y V t least 20 KVA)
'\C en tr if ug e for Q iewer for PA M et ho
ua nt it at iv e Buff)i Clinical centrifuge d
M al ar ia de te ct io n C oa t M et ho d for
C en tr if ug e for Q ua
nt it at iv e B uf fJ C oa
'-'V ·< Malaria detection· t M et ho d fo r
~""··
Refrigerated C :e nt · ·
Pl~C::rn~ -c ri fu ge w / AVR~- .•
Table 1 - BB I BC M IN I M UM
BANK I CENTER CATEGO I INSTRUMENTS
RY A BLOOD BANK I CENTER
':;~';,Hal" Based B
. I. No n- Ho sp ita l -B as ed
~Equipment set w I AVR
. EIA Eq ui pm en t se t w I AV
R
EI Ar ea de r w ith pr in ter
including he ati ng block EI Aw as he r
diluter w I Go-no-Go tester Incubator including he ati ng
se t bl oc k
ioscope, Binocular wi th Oi Microdiluter w I Go-no-Go
l Im me rsi on Objective tester set
with UV Paralens ad ap ter Microscope, Binocular, wi
for Malaria th ·
,siteDetection UV Para!ens ad ap te fw ith
Oi l hn me rsi on
Objective forMaJaria P~f~si
. Pipettor, 10~100ul te Detection
PlasmaEi<tractor ·
Plat~l~t Rotator , · ·.·
.·Reagent Re,frigeratot w l A
)watch or T1mer Ro tat pr fo r RPR/Vl)RL VR &. th en no me ter
·. . .
fe rb ath w/ th er m om ete r (l StopWatch or11irler ·: ·
O~lOOC)
w
.• Waterbath I thermomete
r (10-lQOC)
-FniW~rcl Ty pin g (sl ide /tu be 'Fo r ABO 2ro up ing "' .> . , ·. . .. . . . . •· . .
me tho d) · -Fpryvard~';f)>ping (sl ide /tu be
·.. 4u ti7 AT yp ing ser a :lllethod) . ·.
ser a ·· ·
-Reverse Typi~g (tu be lll.ethod)c Anti-B Typing ser a . ..
· · ·. .
. . ' . "R eye rse Ty pin g (tu be
method).
·· Kn ow nA cel ls •
· · I<rtowri Bcells · ·
'·::~1-':·.<.;~f:> .._·_._.. ,
,:~;}~,,_.,,... ~..
.,,~ ...... ,...--~~--
v•-..•-••"'~~·'"
' '•"•-"'--•
·•--~.,..---.,
w-'-·~···--·
·~·----- <v ;0 /'
T ab le 2 - BB IB
C . M IN I M
U M R E Q U IR
LUUU BA
NK I CENTER EMENTS FO
CATEGORY R REAGENT
A S
BLOOD BAN
;t:reening T es t K I CENTER C
for S y p h il is ATEGORY B
.
B. S c re e n in g T
or es t fo r S y p h il
is
.· VDRL Test K
it or
$ c re e n in g T es
t fo r H IV -A b
.· . RPR C a rd T
est Kit
/
C. S c re e n in g
Test fo r H IV -A
or b.
or H IV 1 & 2 PA
T
·. HIV 1 & 2 EIA Kest Kit o r
it or
..· D~ S c re e n in
g Test fo rH B s.
Ag/
EIA Testi<it
··...
E. Scr~e~ing T
or e st fo r H C y '- A b
E IA T e st K it
.. PATestKif·•····.·· or
I t H o sp it a l- B
a se d
A ll th o se st a te
da b o v e p i tiS .the
fo ll o w in g :
Known A Cells
Known BCells
F o r C o m p a ti b
il it y T e st in g
·. -C ro ss m a tc h
l.
l
. in g .
''
22o/oBovineSerun
1A
Anti-Human Glo Jburnin
bulin Reagent
Known A Cells
Known B Cells .
_j
22%BovineSerum
Anti-Human Glo
Albumin .
bulin ~eag ent _
,:~;}~,,_.,,... ~..
.,,~ ...... ,...--~~--
v•-..•-••"'~~·'"
' '•"•-"'--•
·•--~.,..---.,
w-'-·~···--·
·~·----- <v ;0 /'
T ab le 2 - BB IB
C . M IN I M
U M R E Q U IR
LUUU BA
NK I CENTER EMENTS FO
CATEGORY R REAGENT
A S
BLOOD BAN
;t:reening T es t K I CENTER C
for S y p h il is ATEGORY B
.
B. S c re e n in g T
or es t fo r S y p h il
is
.· VDRL Test K
it or
$ c re e n in g T es
t fo r H IV -A b
.· . RPR C a rd T
est Kit
/
C. S c re e n in g
Test fo r H IV -A
or b.
or H IV 1 & 2 PA
T
·. HIV 1 & 2 EIA Kest Kit o r
it or
..· D~ S c re e n in
g Test fo rH B s.
Ag/
EIA Testi<it
··...
E. Scr~e~ing T
or e st fo r H C y '- A b
E IA T e st K it
.. PATestKif·•····.·· or
I t H o sp it a l- B
a se d
A ll th o se st a te
da b o v e p i tiS .the
fo ll o w in g :
Known A Cells
Known BCells
F o r C o m p a ti b
il it y T e st in g
·. -C ro ss m a tc h
l.
l
. in g .
''
22o/oBovineSerun
1A
Anti-Human Glo Jburnin
bulin Reagent
Known A Cells
Known B Cells .
_j
22%BovineSerum
Anti-Human Glo
Albumin .
bulin ~eag ent _
T ab le 2 - BB./B
C M IN I M U M R
EQUIREMEN TS F O R REAG
r> .n :n B A N K I CENT
ER CATEG ENTS
ORY A
B L O O D BAN
K I CENT ER CATEGOR
Y B
For P re li m in ar
y In v es ti g at io n o f
T ra n sf u si o n
R ea ct io n s
.C o m p at ib il it y
T es ti n g
·1. A B O G ro u
p in g
.· ·. -F o rw ar d T y p
· A n ti -A T y p m g in g (s li d e/ tu b e
se ra m et h o d )
· · ·
AnticB Typing se ·
ra . .·
· -Rev se .Typin ,
·K n o w n A ceer g (t u b e m et h o d . ·..
lls ·· · ) •..•
Known B cells · · .· ···
··:
.·.·... .
... 2. Jlli 'fy'pirlg
(t!J,be itlethod)
·- .. A n tF P with ap ..·,.· . .. .
.
..-. .. . . p t( )p ri at e co n tr
'•,' •, _; -~
. . . .
o, l.
· 3. C io ss m at ch
in g ·
·.KnownA Cells
·
KnownB Cells ..•.
·; .
-. ·· 22"/oBovine Si'!tl.lm
Albi.imin
Anti"Human Globu
lin Reagent
· 4. B ac te ri al C
u it u re (c/o Clinical L
aboratory)
For C o m p le te In
v es ti g at io n o f T
(r ef er to R ef er ra n sf u si o n R ea
en ce L ab ct io n s
1. A n ti b o d v ld en H o ra to ry ) ·
fi ca ti o rt
•·
·------~-· ··. -
- "' ~- ~-~-
·--·-·· .........,,... ____ _ _ . ..:-·•- ~·.
(Information
, Education,
& C a m p a ig
n) Materials:
IEC (Informa
tion, Educati
·P o s te rs on, & Campa
ign) Materials
Leaflets · :
Education.& Brochures
C o u n c e ll in g
iEC Materia
ls
H e a lt h Educ
ation & C o u n
Posters c e ll in g IEC M
aterials . ·
Leaflets
)~.$election Brochures
andS
:b o ri o rD e d a c re e n ir ig
ra ti o n Form
Donor lvl:edit D o n o r. SeleC
al:History & tion andScr
DonorDeCiara ;~erting
.:; :
·PJ:i.ysical Exa .
mination Form ·. Donor'Medi tio'n•Form
s. c~LHJ;tory &
· ·•'•"·Physical
,., . ..
.,- .E·_·
x,·.,'iiminatiori F
orms ·
Hen.toglobiri
Det.?J.miriatio
:ISo?roi>vlAlc . Lancet n: . ·.
ohol, 70% · ·
·. . . . nee . · ·· .· · Tourniqu
dles, disposa et
~ipefte, d is ples · lsopropy1A
posable,plas lcohol,1Q;/o
tic .·. :' · S y ri n g e s w /r ·
ie e a le s ,d is p o
Pipette, dispo s a b le s
~ouping sable, plastic
(S Pipette tips
\.pplical:or Slitidcke sM e th o d ) ..
~orii:i.a1 Saliz1 ABO G ro u p in
i~~---t-·::·\.
e Solution(NS g (Slicie Meth
S, Sterile) Applicator Sti od)
· D is p o s a l cks
Normal Salin
~odium H y eSolution (N
poch SS, Sterile)
:J:3ioha'z.ard Pla lorite Solution P ro p e r Waste
stic Bags D is p o s a l
:~olor-coded Sodium Hypo
Plastic Dispo chlorite Solu
~-~· sable Trash B Biohazard Pla tion
--
~'-:':-·..:-}.;>•:'
ag s stic Bags
Color-coded .
Plastic Dispo .
sable Tra
s~ ·
··- ,, ~·~..;_._.~ . .-:-•.::~~~£/'W&fii
iosafety
Personnel protection Biosafety
Laboratory gow n Personnel protection
Gloves, disposable, latex Laboratory gow n
Emergency Medical Kit Gloves, disposable, latex
Emergency Medical Kit
ood Col lect ion
Ski n Pre para tion & Dis infe ctio n Blo od Collection
'1. Ski n Pre para tion & Disinfection
Cot ton I Gauze
Isop rop yl Alcohol, 70% · Cot tori / Gauze
Phl ebo tom y . . Isopropyl Alcohol, 70%
' ,Tourniquet 2,1''hlebotomy
· · ·• Surgical Tape Tourniquet
·. ·•. Bloqci Bitgs w I AntiCoagulant SurgiCal Tape . . . . .
.· ;. · 2?0 ml · Smgle ·· B~ood Bag sw/ Ari tico agu lant . ·
'450rnl ·· 250 ml ·. • Single ·
Double
c:. . Triple:. · · . 450 rriL. ·' · · 'Do uble
. Qua dru ple Triple .· . ··
Qup,~iupi~ ·
Slide Carrier
Slide C ar rie r Syringes, 1-2 ml
Syringes, 1-2 m l Test Tube Racks
Test Tube Racks ood & Blood C om po ne
nt s
. Pr ov is io n of Whole Bl
& R ed B lo od Cells Transfer bags
si on of W ho le B lo od
Transfer ba gs & D is tri bu tio n of W ho le Bloo
d&
. Tra.nspo 1rt Is su an ce
& tr ib ut io n of Whole. B lo od &
>port, Is su an ce D is B lo od Produc.t cks or iee bags
Blood C el ls .Cold Box w ith cold pa
ck s or ice ba gs oks
'c ol d Box w ith cold pa Lqgbooks I Record bo
books
:;Logbooks I Record
IL H os pi ta l ~ Based
ove pl t)s th e fo llo w in g: ..··· ·
w in g: ' . ··All th os e st at ed in ab -., ··- .:
. ab ov e pl us th e fo llo ·. '- . --:::.- : ·. . -..,..._<_
-,
1. B io sa fe ty ··
· ·P er so nn el pr ot ec tio n'
', > •
Laboratory goVtltl .. ·
tex:.
Gloves!·disp9sable! .• Ia ·,;.
,;.
Slide Carrier
Slide C ar rie r Syringes, 1-2 ml
Syringes, 1-2 m l Test Tube Racks
Test Tube Racks ood & Blood C om po ne
nt s
. Pr ov is io n of Whole Bl
& R ed B lo od Cells Transfer bags
si on of W ho le B lo od
Transfer ba gs & D is tri bu tio n of W ho le Bloo
d&
. Tra.nspo 1rt Is su an ce
& tr ib ut io n of Whole. B lo od &
>port, Is su an ce D is B lo od Produc.t cks or iee bags
Blood C el ls .Cold Box w ith cold pa
ck s or ice ba gs oks
'c ol d Box w ith cold pa Lqgbooks I Record bo
books
:;Logbooks I Record
IL H os pi ta l ~ Based
ove pl t)s th e fo llo w in g: ..··· ·
w in g: ' . ··All th os e st at ed in ab -., ··- .:
. ab ov e pl us th e fo llo ·. '- . --:::.- : ·. . -..,..._<_
-,
1. B io sa fe ty ··
· ·P er so nn el pr ot ec tio n'
', > •
Laboratory goVtltl .. ·
tex:.
Gloves!·disp9sable! .• Ia ·,;.
,;.