Professional Documents
Culture Documents
S: 26/2013/TT- BYT
THNG T
Hng dn hot ng truyn mu
Chng II
TUYN CHN NGI HIN MU V LY MU
Mc 1
IU KIN HIN MU
iu 4. Tiu chun ngi hin mu
Ngi hin mu l ngi c tiu chun v tui, sc khe v cc iu
kin khc, c th nh sau:
1. Tui: t 18 tui n 60 tui.
2. Sc khe:
a) Ngi c cn nng t nht l 42 kg i vi ph n, 45 kg i vi nam
gii c php hin mu ton phn; ngi c cn nng t 42 kg n di 45 kg
c php hin khng qu 250 ml mu ton phn mi ln; ngi c cn nng 45
kg tr ln c php hin mu ton phn khng qu 09 ml/kg cn nng v khng
qu 500ml mi ln.
b) Ngi c cn nng t nht l 50 kg c php hin cc thnh phn mu
bng gn tch; ngi hin mu c th hin mt hoc nhiu thnh phn mu trong
mi ln gn tch, nhng tng th tch cc thnh phn mu hin khng qu 500 ml;
Ngi c cn nng t nht l 60 kg c php hin tng th tch cc thnh phn
mu hin mi ln khng qu 650 ml.
c) Khng mc cc bnh mn tnh hoc cp tnh v thn kinh, tm thn, h
hp, tun hon, tit niu, tiu ho, gan mt, ni tit, mu v t chc to mu, bnh
h thng, bnh t min, tnh trng d ng nng; khng mang thai vo thi im
ng k hin mu (i vi ph n); khng c tin s ly, hin, ghp b phn c th
ngi; khng nghin ma tu, nghin ru; khng c khuyt tt nng v khuyt tt
c bit nng theo quy nh ti Lut Ngi khuyt tt; khng s dng mt s thuc
c quy nh ti Ph lc 1 ban hnh km theo Thng t ny; khng mc cc bnh
ly truyn qua ng mu, cc bnh ly truyn qua ng tnh dc ti thi im
ng k hin mu;
d) Lm sng:
- Tnh to, tip xc tt;
- Huyt p tm thu trong khong t 100 mmHg n di 160 mmHg v
tm trng trong khong t 60 mmHg n di 100 mmHg;
3
2. c gii thch v quy trnh ly mu, cc tai bin khng mong mun c
th xy ra, cc xt nghim s thc hin trc v sau khi hin mu.
3. c bo m b mt v kt qu khm lm sng, kt qu xt nghim;
c t vn v cc bt thng pht hin khi khm sc kho, hin mu; c
hng dn cch chm sc sc kho; c t vn v kt qu xt nghim bt thng
theo quy nh ti Khon 3 v Khon 4 iu 17 Thng t ny.
4. c chm sc, iu tr khi c cc tai bin khng mong mun xy ra
trong v sau hin mu theo quy nh ti Ph lc 4 ban hnh km theo Thng t
ny. c h tr chi ph chm sc, iu tr khi c cc tai bin khng mong mun
xy ra trong v sau hin mu. Kinh ph h tr chm sc iu tr ngi hin mu
theo quy nh ti Khon ny c thc hin theo quy nh ca php lut.
5. c c quan c thm quyn xem xt, quyt nh tn vinh, khen thng
v bo m cc quyn li khc v tinh thn, vt cht ca ngi hin mu theo quy
nh ca php lut.
Chng III
XT NGHIM CC N V MU TON PHN
V THNH PHN MU
iu 13. Nguyn tc xt nghim
1. Phi thc hin xt nghim sng lc cho mi n v mu, thnh phn
mu. Khng c quy chiu kt qu xt nghim thc hin t trc hoc cc ln
hin mu trc ca ngi hin mu cho n v mu, thnh phn mu mi hin, tr
trng hp quy nh ti Khon 3 iu 15 Thng t ny.
2. Chn la, s dng cc thuc th, sinh phm, dng c, thit b xt nghim
bo m cht lng xt nghim sng lc n v mu theo quy nh ca php lut.
Thc hin kim sot cht lng sinh phm, kim tra cht lng xt nghim.
3. Thc hin cc quy trnh xt nghim, phng cch xt nghim, phn tch
kt qu ph hp vi sinh phm, trang thit b, dng c hin c v c lnh o
n v thc hin xt nghim ph duyt.
4. Thc hin xt nghim sng lc cc tc nhn ly truyn qua ng mu
cho n v mu, thnh phn mu phi bo m cc yu cu sau:
a) Mu mu xt nghim phi cng ngun gc vi n v mu, thnh phn
mu theo quy nh ti iu 10 Thng t ny;
8
st rt trong thi gian 06 thng hoc nhng ngi c tin s mc bnh st rt trong
thi gian 12 thng k t khi iu tr khi bnh st rt;
b) Xt nghim CMV (Cytomegalovirus) i vi cc n v ch phm mu
truyn cho ngi bnh c ghp m, ghp t bo gc hoc truyn mu cho thai
nhi hoc mt s trng hp c bit khc theo yu cu ca bc s iu tr.
3. Xt nghim b sung: trong mt s trng hp bo m an ton cho
ngi bnh nhn mu, cc c s truyn mu c iu kin k thut c thc
hin xt nghim b sung theo ch nh ca bc s iu tr.
4. Yu cu k thut i vi cc xt nghim bt buc:
a) nh nhm mu h ABO: phi thc hin bng 2 phng php huyt
thanh mu v hng cu mu vi k thut ti thiu tng ng hoc cao hn k
thut thc hin trong ng nghim. Nhm mu ch c kt lun khi c s ph hp
kt qu ca hai phng php hoc c khng nh bng cc xt nghim b sung;
b) nh nhm mu h Rh(D): phi thc hin bng phng php huyt
thanh mu vi k thut ti thiu thc hin trong ng nghim. Ch c kt lun
n v mu c nhm Rh(D) m, sau khi thc hin xt nghim khng nh bng
xt nghim tng ng hoc cao hn k thut khng globulin gin tip;
c) Xt nghim sng lc khng th bt thng phi thc hin k thut xt
nghim c kh nng pht hin cc khng th bt thng, ti thiu thuc cc h
nhm hng cu Rh, MNSs, Kell, Kidd, Duffy, Lutheran theo l trnh quy nh ti
iu 70 Thng t ny;
d) Xt nghim sng lc HIV: phi thc hin bng k thut c nhy,
c hiu tng ng hoc cao hn k thut ELISA hoc ho pht quang vi sinh
phm c kh nng pht hin ng thi khng nguyn, khng th HIV-1 v HIV-2;
) Xt nghim sng lc vi rt vim gan B: phi thc hin xt nghim pht
hin khng nguyn HBsAg bng k thut c nhy, c hiu tng ng
hoc cao hn k thut ELISA hoc ho pht quang;
e) Xt nghim sng lc vi rt vim gan C: phi thc hin bng k thut c
nhy, c hiu tng ng hoc cao hn k thut ELISA hoc ho pht
quang vi sinh phm c kh nng ti thiu pht hin c khng th vim gan C;
g) Xt nghim sng lc HIV-1 v HIV-2, vi rt vim gan B, vi rt vim gan
C bng k thut NAT c p dng i vi tt c cc n v mu, thnh phn mu
theo l trnh quy nh ti iu 70 Thng t ny;
10
h) Xt nghim sng lc giang mai: phi thc hin xt nghim pht hin
giang mai bng k thut c nhy v c hiu tng ng hoc cao hn k
thut RPR;
i) Xt nghim sng lc st rt: phi thc hin xt nghim bng k thut c
nhy tng ng hoc cao hn k thut tm k sinh trng st rt trn tiu bn
git c, git n v c kt qu bng knh hin vi quang hc;
k) Xt nghim CMV: phi thc hin xt nghim pht hin khng th IgM,
khng CMV bng k thut c nhy tng ng hoc cao hn k thut ELISA
hoc ho pht quang.
5. Th t thc hin cc xt nghim sng lc HIV, vim gan vi rt B, vim
gan vi rt C, giang mai do lnh o n v ph duyt. Kt lun n v mu, thnh
phn mu an ton vi cc tc nhn ny phi cn c kt qu xt nghim thc
hin bng k thut ELISA v k thut NAT hoc ha pht quang v k thut NAT.
6. Phi p dng cc bin php bo m cht lng xt nghim cc n v
mu, thnh phn mu theo quy nh ti Ph lc 5, Ph lc 6 ban hnh km theo
Thng t ny.
iu 15. Xt nghim sng lc cc tc nhn ly truyn bnh qua ng
mu trong trng hp c bit
1. Vic xt nghim sng lc HIV-1 v HIV-2, vim gan vi rt B, vim gan
vi rt C i vi n v mu trc khi truyn bng phng php xt nghim nhanh
ch c thc hin khi p ng cc iu kin sau:
a) Ch p dng vi cc c s y t min ni, vng su, vng xa, bin gii
v hi o;
b) Ch p dng vi cc n v mu ton phn; khng p dng vi cc n
v thnh phn mu;
c) Bc s iu tr ch nh truyn mu v c ghi trong h s bnh n;
d) lin h vi c s truyn mu gn nht, nhng khng c n v mu
ha hp hoc thi gian nhn mu t c s truyn mu gn nht khng p ng yu
cu cp cu ngi bnh;
) Ngi bnh hoc ngi i din hp php ca ngi bnh k xc nhn vo
h s bnh n v vic ng truyn n v mu ch sng lc bng xt nghim nhanh,
sau khi c nhn vin y t gii thch v nguy c ly nhim bnh c th xy ra;
e) Xc nhn ca ph trch khoa, phng khm bnh, cha bnh hoc ngi
11
Chng IV
IU CH, BO QUN, VN CHUYN MU V CH PHM MU
Mc 1
CC YU CU CHUNG
iu 18. Nguyn tc chung
1. Ch s dng ti ly mu, ti gn tch thnh phn mu (bao b ng mu)
bo m cht lng v c ngun gc r rng.
13
(-
1. Tn, a ch c s iu ch mu v ch phm.
2. Tn loi ch phm mu.
3. M s ca n v mu, ch phm mu: ch c mt m s duy nht cho
php truy nguyn cc thng tin v ngi hin mu, qu trnh ly mu, sng lc,
iu ch, lu tr, vn chuyn, phn phi v s dng n v mu, ch phm mu.
4. Nhm mu h ABO v Rh(D); thng tin v cc nhm mu khc (nu c).
5. Ngy, thng, nm ly mu.
6. Tn dung dch chng ng hoc dung dch bo qun (i vi mu ton
phn hoc khi hng cu).
7. Ngy ht hn s dng.
8. Th tch hoc cn nng ca n v ch phm mu.
9. Nhit bo qun.
10. Ghi ch trn tt c nhn ca ti mu, ch phm mu: Cn truyn qua b
dy truyn c bu lc; khng c truyn nu c hin tng tan mu, mu sc bt
thng. Ring vi mu, ch phm mu chiu x, cn ghi thm: chiu x.
Mc 2
TIU CHUN CA MT S CH PHM MU
iu 22. Mu ton phn
1. Tiu chun: ly t ngi hin mu c tuyn chn theo quy nh ti
iu 4 Thng t ny v khng thuc cc trng hp phi tr hon hin mu theo
quy nh ti iu 5 Thng t ny. Cc n v mu ton phn ny phi c kt qu
an ton vi cc xt nghim c quy nh ti iu 14, iu 15 Thng t ny.
2. iu kin bo qun v hn s dng:
a) Khi bo qun nhit t 2C n 6C, hn s dng ca mu ton phn
khng qu 21 ngy vi dung dch chng ng Citrat-Phosphat-Dextrose v khng
qu 35 ngy vi dung dch Citrat-Phosphat-Dextrose-Adenin;
b) Khi bo qun nhit t 20C n 24C, hn s dng ca mu ton
phn khng qu 24 gi.
3. Kim tra cht lng (c thc hin vi s lng mu ly ngu nhin
theo t l t 0,1% n 1% tng s n v mu ton phn v khng t hn 05 n v
trong mi thng) v cc tiu chun sau:
17
a) Th tch chnh lch khng qu 10% th tch ghi trn nhn (khng bao
gm th tch dung dch chng ng);
b) Kim tra vic thc hin cc xt nghim theo quy nh ti iu 14, iu
15 Thng t ny;
c) Nng hemoglobin ti thiu 10g trong mi th tch 100 ml mu ton
phn;
iu 23. Khi hng cu m c
1. Khi hng cu m c (hng cu lng) l phn cn li ca mu ton
phn tch huyt tng sau khi ly tm hoc lng v khng thc hin thm bt
k cng on x l no khc.
2. Tiu chun v kim tra cht lng
Thc hin kim tra cht lng (vi s lng mu ly ngu nhin theo t l
t 0,1 n 1% tng s n v c iu ch v khng t hn 05 n v trong mi
thng) v cc tiu chun sau:
a) Th tch n v khi hng cu bng 60% 15% th tch mu ton phn
ban u;
b) Lng hemoglobin ti thiu l 10g t mi 100ml mu ton phn c
iu ch;
c) Hematocrit t 0,65 n 0,75.
3. iu kin bo qun v hn s dng: nh mu ton phn quy nh ti
im a Khon 2 iu 22 Thng t ny.
iu 24. Khi hng cu c dung dch bo qun
1. L khi hng cu m c c b sung dung dch bo qun hng cu nhm
ci thin cht lng hng cu.
2. Tiu chun v kim tra cht lng
Thc hin kim tra cht lng (vi s lng mu ly ngu nhin theo t l
0,1% n 1% tng s n v c iu ch v khng t hn 05 n v trong mi
thng) v cc tiu chun sau:
a) Phi s dng dung dch bo qun c Adenin trong thnh phn;
b) Th tch n v ch phm bng 70% 15% th tch n v mu ton phn
ban u;
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trong dung dch mui ng trng hoc trong dung dch bo qun hoc trong huyt
tng ph hp.
2. Tiu chun v kim tra cht lng
Thc hin kim tra cht lng (vi s lng mu ly ngu nhin theo t l
10% tng s n v c iu ch) v cc tiu chun sau:
a) Th tch n v ch phm ny bng 65% 15% th tch mu ton phn
ban u;
b) Nng protein trong nc ni cui cng t hn 0,5g/n v khi hng
cu;
c) Lng hemoglobin ti thiu l 9,0g t mi th tch 100 ml mu ton phn
ban u;
d) Hematocrit t 0,50 n 0,70;
3. iu kin bo qun v hn s dng: i vi ra khi hng cu trong h
thng h, bo qun nhit t 2oC n 6 oC hn s dng trong vng 24 gi k t
khi kt thc iu ch; trng hp bo qun nhit 20 oC n 24oC, hn s dng
trong vng 6 gi k t khi kt thc iu ch.
iu 27. Khi hng cu lc bch cu
1. Khi hng cu lc bch cu l khi hng cu c loi b bch cu bng
b lc bch cu. Vic lc bch cu phi c thc hin trong thi gian 72 gi, k
t khi ly mu t ngi hin.
2. Tiu chun v kim tra cht lng
Thc hin kim tra cht lng (vi s lng mu ly ngu nhin theo t l
5% tng s n v c iu ch) v cc tiu chun sau:
a) Th tch n v khi hng cu bng 65% 15% th tch mu ton phn
ban u;
b) Lng hemoglobin ti thiu l 9,0g t mi th tch 100 ml mu ton phn
ban u;
c) Hematocrit t 0,50 n 0,70;
d) S lng bch cu cn li t hn 1,010 6 trong mi n v khi hng cu.
Phi c t nht 90% s n v mu c kim tra t tiu chun ny;
3. iu kin bo qun v hn s dng: theo quy nh ti Khon 3 iu 24
Thng t ny.
20
21
Thc hin kim tra cht lng (vi s lng mu ly ngu nhin theo t l
1% n 5% tng s n v c iu ch v khng di 10 n v trong mi
thng) v cc tiu chun sau:
a) Th tch n v: th tch t 40 ml n 60 ml iu ch t mi n v mu
ton phn c th tch t 250ml tr ln;
b) m s lng tiu cu: c ti thiu 1310 9 tiu cu trong n v khi tiu
cu iu ch t mi th tch 100 ml mu ton phn. C t nht 75% s n v mu
c kim tra phi t tiu chun ny;
c) m s lng bch cu trong mi n v khi tiu cu:
- t hn 0,05109 bch cu i vi khi tiu cu iu ch bng phng php
tch lp bch cu - tiu cu. C t nht 75% s n v mu c kim tra phi t
tiu chun ny;
- t hn 0,2109 bch cu i vi khi tiu cu iu ch bng phng php
huyt tng giu tiu cu. C t nht 75% s n v mu c kim tra phi t
tiu chun ny;
d) pH phi t t 6,4 n 7,4 khi o nhit 22oC vo cui thi gian
bo qun;
) Xt nghim nui cy pht hin vi khun phi c kt qu m tnh.
3. Tiu chun v kim tra cht lng n v pool khi tiu cu iu ch t
nhiu n v mu ton phn.
Thc hin kim tra cht lng (vi s lng mu ly ngu nhin theo t l
1% n 5% tng s n v c iu ch v khng di 10 n v trong mi
thng) v cc tiu chun sau:
a) Th tch n v: th tch t 120 ml n 200 ml iu ch t 1.000ml mu
ton phn;
b) m s lng tiu cu: c ti thiu 140109 tiu cu trong mt n v
khi tiu cu. C t nht 75% s n v c kim tra phi t tiu chun ny;
c) m s lng bch cu: t hn 1,0109 bch cu trong mi n v khi
tiu cu;
d) pH v nui cy pht hin vi khun: theo quy nh ca im c, d
Khon 2 iu ny.
22
24
26
2. Tiu chun v kim tra cht lng: thc hin kim tra cht lng (vi s
lng mu ly ngu nhin theo t l 10% tng s n v c iu ch) v cc tiu
chun sau:
a) Th tch n v ch phm: t 250 ml n 300 ml;
b) C 10109 bch cu ht trung tnh trong mi n v ch phm v t nht
75% s n v ch phm c kim tra t tiu chun ny.
3. iu kin bo qun v hn s dng: bo qun nhit t 20 oC n
24oC, khng lc, trong vng 06 gi k t thi im iu ch v trong vng 24 gi
k t thi im ly mu.
iu 36. Cc ch phm mu truyn cho thai nhi
1. Khi hng cu truyn cho thai nhi l khi hng cu lc bch cu theo quy
nh ti iu 27 ca Thng t ny v phi p ng thm cc yu cu sau:
a) c bo qun nhit t 2oC n 6oC trong vng 05 ngy k t thi
im ly mu;
b) Hematocrit t 0,70 n 0,85;
c) c chiu x.
2. Khi tiu cu s dng cho thai nhi l khi tiu cu lc bch cu theo quy
nh ti iu 31 Thng t ny, ngoi ra c th c chiu x theo ch nh ca bc
s iu tr lm sng.
iu 37. Mu s dng trong truyn thay mu cho tr s sinh
1. Mu ton phn s dng truyn thay mu cho tr s sinh: phi p ng
cc iu kin theo quy nh ti iu 22 Thng t ny v c bo qun trong vng
05 ngy k t thi im ly mu. Mu ton phn s dng truyn cho tr s sinh
c th lc bch cu, chiu x theo ch nh ca bc s iu tr lm sng.
2. Mu ton phn khi phc s dng truyn thay mu cho tr s sinh: l
khi hng cu c iu ch theo quy nh ti mt trong cc iu 23, 24, 25, 26,
27 v 28 Thng t ny v c b sung huyt tng ti hoc huyt tng ti
ng lnh quy nh ti iu 33 Thng t ny khi phc c tnh nh mu ton
phn, ngoi ra phi p ng cc yu cu sau:
a) Khi hng cu c bo qun trong vng 05 ngy tnh t ngy ly mu
hoc ngy lm tan ng hng cu ng lnh;
b) c loi b dung dch bo qun sau khi ly tm;
27
Chng V
QUN L, S DNG MAU VA CH PHM MAU C S IU TR
iu 38. Nguyn tc cp pht, s dung, thu hi mau va ch phm mau
1. Ch c cp pht n v mu v ch phm mu cho ngi bnh khi:
khng pht hin thy nguy c nhim cc tc nhn ly truyn bnh qua ng mu;
c y kt qu xt nghim nh nhm mu h ABO, Rh(D); n v mu, ch
phm mu t tiu chun quy nh tng ng v khng vt qu thi hn s dng
theo quy nh i vi tng loi; khng c cc du hiu bt thng khi kim tra
hnh thc bn ngoi; bo m ha hp min dch gia n v mu, ch phm mu
v ngi c truyn mu.
2. Thu hi, cch ly cc n v mu, ch phm mu trong:
a) Cc trng hp quy nh ti Khon 2, Khon 3 iu 17 Thng t ny;
b) Cc trng hp quy nh ti Khon 2 iu 41 Thng t ny.
c) Cc n v mu ton phn v cc ch phm huyt tng, khi tiu cu,
khi bch cu iu ch t n v mu, thnh phn mu khi xt nghim khng th
bt thng theo quy nh ti im c Khon 4 iu 14 Thng t ny c kt qu
dng tnh hoc nghi ng dng tnh.
3. Ch nh s dng truyn mu hp l trn c s tnh trng bnh l ca
tng ngi bnh.
4. B phn pht mu ca c s khm bnh, cha bnh thc hin xt nghim
ha hp min dch truyn mu v trc tip cp pht mu cho cc khoa iu tr lm
28
sng thuc c s khm bnh, cha bnh thc hin truyn mu, ch phm mu
cho ngi bnh.
iu 39. Giao, nhn mu v ch phm mu
Vic giao, nhn mau va ch phm mau gia c s cung cp mau vi c s
kham bnh, cha bnh hoc gia cac c s kham bnh, cha bnh vi nhau ch
c thc hin khi p ng cc iu kin sau:
1. C s y t c c quan c thm quyn cho php thc hin vic cung
cp mu cho c s kham bnh, cha bnh khc;
2. C hp ng hp php cung cp mau gia c s cung cp v c s nhn
mu, ch phm mu;
3. C phiu d tr, cung cp mu v ch phm mu theo quy inh tai Ph
lc 8 ban hnh km Thng t ny;
4. Trng hp khng c hp ng cung cp mu: phiu d tr phi c xc
nhn ca i din lnh o hoc ngi c y quyn ca c s kham bnh, cha
bnh ;
5. C cac nhn vin y t thc hin vic giao v nhn mu;
6. C phng tin bo qun, vn chuyn mu v ch phm mu ph hp;
7. H s giao nhn mu phi c lu gi v kim sot theo quy nh ti
iu 61 Thng t ny.
iu 40. Nhp kho, i chiu, bo qun mu ti n v pht mu ca
c s khm bnh, cha bnh
1. Mu v ch phm mu trc khi nhp kho phai c i chiu, kim tra:
a) Hnh thc bn ngoi v bao gi theo quy nh ti iu 41 Thng t ny;
b) Thng tin trn nhn theo quy nh ti iu 21 Thng t ny;
c) iu kin bo qun, vn chuyn mu ph hp vi tng loi mu, ch
phm mu theo cc quy nh ti cc iu 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,
33, 34 v 35 Thng t ny.
d) Ngi kim tra, i chiu phi bo co ngi ph trch n v pht mu v
cc bt thng pht hin c khi i chiu xem xt, quyt nh cch thc x l.
2. Bo qun ring r cc tui mu, ch phm mu theo nhm mu A, B, O, AB,
Rh(D) m trong cc ngn (khoang) khc nhau ca thit b lnh hoc trong cc thit
b lnh ring bit.
29
Nhm mu n v mu truyn
Khi hng cu
Mu ton phn
O
O
A hoc O
A
B hoc O
B
AB hoc A hoc B hoc O
AB
A hoc AB
B hoc AB
AB
AB
A hoc O
B hoc O
AB
AB
34
Nhm mu ca n v mu truyn
D(-)
D(-)
D(+)
b) Thi gian t khi kt thc vic lm tan ng n khi kt thc vic truyn
mu cho ngi bnh khng qu 06 gi;
c) Sau khi lm tan ng, phi kim tra tnh trng ti mu, ch phm mu
quy nh ti Khon 2 iu 41 Thng t ny. Nu phat hin tui mau khng bao am
cht lng thi phi hy tui mau o.
2. m on dy truyn n v ch phm mu khi cn truyn nhanh v
khi lng ln (trn 50 ml/kg/gi ngi ln v trn 15 ml/kg/gi tr em). Nhit
m khng vt qu 37oC.
iu 47. Giao nhn mu, ch phm mu gia n v pht mu v n
v iu tr
1. Khi giao nhn mu, ch phm mu, nhn vin n v iu tr lnh mu v
nhn vin cua n v pht mu phi thc hin i chiu thng tin trn phiu d tr
mu, n v mu v phiu truyn mu.
2. C phng tin bo qun, vn chuyn mu, ch phm mu ph hp.
iu 48. Lu tr mu ca n v mu v mu mu ngi bnh nhn mu
Sau khi cp phat, mu mu ca ngi bnh nhn mu v mu n v mu
cp pht phi c lu gi t nht 05 ngy nhit t 2 oC n 6oC ti n v
pht mu.
iu 49. Qun l tui mu n v iu tr
1. Tui mu chuyn v n v iu tr phai truyn cho ngi bnh trong
vong 06 gi k t thi im giao nhn gia n v pht mu v n v iu tr.
2. Trng hp cha tin hnh truyn mu, cc ti mu hoc ch phm mu
phi c bo qun ph hp theo quy nh tai cc iu 22, 23, 24, 25, 26, 27, 28,
29, 30, 31, 32, 33, 34 v 35 Thng t ny.
iu 50. Thc hin v theo di truyn mu ti n v iu tr
1. Bc s iu tr v iu dng vin phi thc hin kim tra, i chiu,
nh nhm mu, theo di truyn mu, pht hin, x tr kip thi cc bt thng, tai
bin khng mong mun xy ra trong v sau truyn mu.
2. Thc hin kim tra, i chiu cc ni dung sau:
a) i chiu thng tin ca ngi bnh, n v mu v phiu truyn mu;
b) Kim tra hn s dng v hinh thc bn ngoi tui mu theo quy nh ti
iu 41 Thng t ny.
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Chng VI
TRUYN MU T THN
iu 53. Nguyn tc thc hin truyn mu t thn
1. Phi c cc quy trnh truyn mu t thn ph hp vi cc quy nh hin
hnh v iu kin ca c s kham bnh, cha bnh. Cc quy trnh chn la, xt
nghim, ly, iu ch, bo qun v truyn mu t thn phi c lnh o cua c
s kham bnh, cha bnh ph duyt.
2. Ch truyn mu t thn theo k hoch i vi nhng trng hp trc
phu thut c tin lng v nguy c mt mu n mc phi truyn mu v bc s
iu tr c trch nhim cn nhc, nh gi tnh trng sc kho ngi bnh cho php
thc hin ly mau an ton.
3. Vic ly mu theo phng php truyn mu t thn theo k hoch v
truyn mu t thn pha long mu ng tch ch c thc hin khi c s ng
bng vn bn ca ngi bnh hoc ngi i din hp phap ca ngi bnh.
4. Ngoi vic tun th cc quy nh v nhn tui mau theo quy nh ti iu
21 Thng t ny, nhn ca tui mu t thn phi c ghi thm dng ch: Ch
dng cho truyn mu t thn.
5. Cc tui mu t thn phi c bo qun ring bit vi mu ly t ngi
hin mu.
6. Bo m truyn mu, ch phm mau cho ng ngi bnh c ly
mu. Mu thu nhn vi mc ch truyn mu t thn khng c s dng cho
ngi bnh khc.
iu 54. Truyn mu t thn theo k hoch
1. Tiu chun la chon ngi bnh
a) Tui t 16 n 60;
b) Trng lng c th t 50 kg tr ln;
c) Lm sng: theo quy nh ti im Khon 2 iu 4 Thng t ny;
d) Nng Hemoglobin phi t t nht l 120g/l v Hematocrit phi t t
nht 0,33;
39
Chng VII
GIM ST NGUY C TRONG TRUYN MU
iu 57. Ni dung gim st nguy c trong truyn mu
Gim st nguy c trong truyn mu l hot ng nhm phng, pht hin,
cnh bo, lu gi, phn tch, bo co cc nguy c gy mt an ton truyn mu, bao
gm:
1. Thng tin v ngi hin mu.
2. Thng tin v quy trnh, nhn lc, sinh phm, trang thit b, dng c, vt
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t tiu hao thc hin cc hot ng tip nhn, sng lc, iu ch, bo
qun, vn chuyn, cp pht, chi inh, s dung mau trong lm sang.
3. Thng tin v kt qu v cc bt thng trong hot ng truyn mu.
4. Cc thng tin v tai bin xy ra ngi bnh c truyn mu.
5. Cc thng tin khc v cc nguy c, bt thng cho cng ng dn c, x
hi c lin quan n hot ng truyn mu.
iu 58. Qun l, gim st, bo co nguy c trong truyn mu
1. Mi bt thng xy ra trong hot ng truyn mu phi c pht hin,
kim tra, x l, tng hp v bo co theo nh k 6 thng/ln.
2. Khi xy ra cc bt thng c nguy c nh hng n an ton cho ngi
bnh hoc vt qu kh nng x l ca c s khm bnh, cha bnh:
a) Khoa, phng pht hin phi bo co lnh o c s khm bnh, cha
bnh trong thi gian 02 gi, k t khi pht hin;
b) Trong thi gian 24 gi, k t khi nhn c bo co, lnh o c s
khm bnh, cha bnh phi bo co cho c quan qun l cp trn v c s truyn
mu c lin quan.
3. Khuyn khch bo co cc nguy c, bt thng c lin quan n ngi
hin mu, ngi bnh nhn mu, nhn vin y t thc hin cng vic v nhng
ngi khc c lin quan n hot ng truyn mu:
a) Cc bo co thc hin theo quy nh ti Ph lc 13 ban hnh km Thng t ny;
b) Cc bo co ny c gi n Hi ng truyn mu ca c s khm
bnh, cha bnh v Vin Huyt hc - Truyn mu Trung ng.
4. nh k hng nm, cc c s c hot ng truyn mu phi thc hin
vic tng hp, phn tch, xut cc gii php nhm khc phc, hn ch cc bt
thng trong truyn mau v bo co theo quy nh ti iu 62 Thng t ny.
5. Cn c bo co theo quy nh ti Khon 3 v Khon 4 iu ny, Vin
Huyt hc Truyn mu Trung ng thc hin vic tng hp, phn tch, xut
cc gii php, tham mu cho B Y t v cc bin php nhm khc phc, hn ch,
phng nga cc nguy c trong truyn mau.
42
Chng VIII
HI NG TRUYN MU CA C S KHM BNH, CHA BNH
iu 59. V tr php l va thanh phn ca Hi ng truyn mu ca c
s khm bnh, cha bnh
1. Hi ng truyn mu l hi ng chuyn mn c giam c c s kham
bnh, cha bnh quyt inh thnh lp.
2. Hi ng truyn mu (Hi ng) gm cac thanh phn sau:
a) Chu tich hi ng: la Giam c hoc Pho giam c ph trch chuyn
mn;
b) Pho chu tich hi ng: la Pho giam c hoc Trng phong K hoach
tng hp;
c) Th ky hi ng: Trng phong K hoach tng hp hoc ngi ph trch
c s pht mau;
d) Cac Uy vin hi ng gm ai din cac khoa, phong: T chc can b, K
hoach tng hp, iu dng, Dc va cac khoa lm sang co s dung mau.
3. Hi ng co th kt hp vi Hi ng thuc va iu tri trn c s iu
kin thc t co b sung thanh vin, chc nng, nhim vu cua Hi ng theo Khoan
2 iu nay va iu 61 Thng t nay.
iu 60. Chc nng, nhim v ca Hi ng truyn mu
1. Chc nng:
Hi ng truyn mu c chc nng t vn cho lnh o c s khm bnh,
cha bnh v truyn mau an ton, hp l v hiu qu.
2. Nhim v:
a) Ch o xy dng v thm nh cc nguyn tc, quy nh, quy trinh,
hng dn c th v truyn mu ph hp vi cc hot ng xt nghim, iu tr
lm sng ca c s khm bnh, cha bnh;
b) Ch o xy dng k hoach s dung mau va ch phm mau hang nm;
c) xut cc gii php ci thin cht lng hot ng truyn mu; cc k
hoch pht trin hot ng truyn mu, b sung trang thit b, p dng cc k thut
mi;
43
Chng IX
LU GI H S V CH BO CO
iu 61. Lu gi h s
Lnh o c s truyn mu, c s khm bnh, cha bnh, c s pht mu
phi t chc thc hin lu gi ti liu, h s theo cc yu cu sau:
1. Lu gi h s ti c s truyn mu:
a) Ti liu lin quan n hot ng tip nhn mu:
- Bng hi tnh trng sc kho ngi hin mu theo mu quy nh ti Ph
lc 2 ban hnh km theo Thng t ny;
- H s sc kho ngi hin mu theo quy nh ti Ph lc 3 ban hnh km
theo Thng t ny.
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45
- Ti khoa, phng iu tr s dng mu: h s ghi nhn din bin tnh trng
ngi bnh v x tr, iu tr p dng; kt qu xt nghim cc mu mu, nc
tiu trc v sau khi xy ra tai bin lin quan n truyn mu.
3. Cc quy trnh lm vic, h s biu mu ghi chp, h thng kim sot ti
liu c lu tr bao gm dng vn bn thng thng v h thng ti liu in t.
4. H s c lu tr 10 nm tnh t ngy cp nht thng tin ln cui cng.
5. H s ht hn lu tr c hy theo quy nh hin hnh.
iu 62. Ch bo co
Lnh o c s truyn mu v c s khm bnh, cha bnh s dng mu
phi t chc thc hin lp v gi bo co theo cc yu cu sau:
1. Bo co nh k hng nm:
a) Ni dung bo co theo quy nh ti Ph lc 14 ban hnh km theo Thng
t ny;
b) Trc ngy 30/11 hng nm, cc c s y t c s dng mu (k ca cc c
s khm bnh, cha bnh t nhn) gi bo co theo quy nh ti im a Khon 1
iu ny n cc s y t tnh, thnh ph trc thuc trung ng, ng thi gi Vin
Huyt hc - Truyn mu Trung ng;
c) Trc ngy 15/01 ca nm tip theo, Vin Huyt hc - Truyn mu
Trung ng bo co tng hp tnh hnh hot ng truyn mu n B Y t.
2. Bo co t xut: thc hin theo ni dung yu cu ca c quan qun l
hoc theo yu cu thc t m n v cn bo co ln cp trn.
Chng X
TRCH NHIM THC HIN
iu 63. Trch nhim ca Cc Qun l Khm, cha bnh - B Y t
1. Ch tr hoc phi hp xy dng, sa i, b sung cc vn bn quy phm
php lut v hot ng truyn mu; xy dng chin lc, quy hoch, k hoch, cc
chng trnh, d n; xy dng tiu chun quc gia, quy chun k thut, hng dn
chuyn mn c lin quan n truyn mu, trnh B trng B Y t hoc cp c
thm quyn xem xt, quyt nh.
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7. Thc hin nghin cu, p dng khoa hc cng ngh trong truyn mu.
8. Tng hp, phn tch, bo co s liu kt qu hot ng truyn mu ca
cc c s truyn mu trong phm vi ton quc gi B Y t.
iu 65. Trch nhim ca S Y t tnh, thnh ph trc thuc trung ng
1. Ch o, t chc thc hin, qun l, kim tra, nh gi hot ng truyn
mu ca cc c s khm bnh, cha bnh v c s truyn mu trn a bn qun l.
2. Cn c vo nhu cu s dng mu ca cc c s khm bnh, cha bnh,
tng hp, xy dng k hoch s dng mu hng nm ca a phng; ng thi
phi hp vi cc n v c lin quan trong vic vn ng hin mu tnh nguyn,
bo m ngun cung cp mu cho cc c s khm bnh, cha bnh.
3. Kin ngh sa i, b sung cc quy nh, hng dn v chuyn mn,
nghip v, qun l nhm khc phc cc bt cp lin quan n hot ng truyn mu.
4. Tng hp, phn tch, bo co s liu kt qu hot ng truyn mu ca
cc c s khm bnh, cha bnh v c s truyn mu trn a bn qun l gi Cc
Qun l khm, cha bnh, B Y t.
iu 66. Trch nhim ca c s truyn mu
1. Tuyn truyn vn ng ngi hin mu tnh nguyn. Cung cp thng tin
cho ngi hin mu v nhu cu s dng mu, v nguy c ca cc bnh ly truyn
qua ng mu.
2. Gii thch v quy trnh ly mu, cc biu hin khng mong mun, tai
bin c th xy ra, cc xt nghim s thc hin trc v sau khi hin mu; t vn
ngi hin mu cch t chm sc sc kho v cc dch v y t chuyn khoa.
3. Bo m b mt v kt qu khm lm sng v xt nghim. Thng bo cho
ngi hin mu v kt qu khm lm sng, xt nghim khi c yu cu trc tip t
ngi hin mu.
4. Chm sc, iu tr cho ngi hin mu khi c cc tai bin khng mong
mun xy ra trong v ngay sau hin mu.
5. Xy dng, ph duyt, trin khai, gim st thc hin cc quy trnh, hng
dn chuyn mn p dng ti c s truyn mu bo m an ton cho ngi hin
mu v cht lng ca n v mu: ng k hin mu; ghi h s; ly mu an ton
v v trng, gim thiu nguy c nhim khun; chm sc ngi hin mu; phng
nga v x l an ton cc tai bin c th xy ra ngi hin mu; xt nghim sng
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o to cho cc nhn vin c lin quan v t chc thc hin truyn mu theo ng
quy nh ph duyt; t chc gim st vic tun th cc quy nh, quy trnh,
hng dn trong phm vi c s khm cha bnh;
c) Xem xt, phi hp v ch o gii quyt cc vn lin quan khi thc
hin cc cng vic quy nh ti im b, im c v im d Khon 8 iu 66 Thng
t ny vi cc c s truyn mu;
d) T chc thc hin vic qun l, gim st nguy c trong truyn mu c
quy nh ti iu 57, iu 58 Thng t ny;
e) T chc nh gi cht lng hot ng truyn mu v ci thin cht
lng hot ng truyn mu trong phm vi n v theo Ph lc 15 ban hnh km
Thng t ny;
g) Kin ngh sa i, b sung nhm khc phc cc bt cp lin quan n
hot ng truyn mu pht sinh trong qu trnh trin khai cc quy nh ca Thng
t ny.
2. C s pht mu thuc c s khm bnh, cha bnh thc hin xt nghim
ho hp min dch truyn mu c trch nhim:
a) Thc hin cc quy nh hin hnh v ch o ca gim c c s khm
bnh, cha bnh trong vic thc hin cc cng vic c lin quan quy nh ti
Khon 1 iu ny;
b) Xc nh nhu cu, lp k hoch s dng v t chc phi hp thc hin
vn chuyn, bo qun mu, ch phm mu an ton, ph hp theo nhu cu v s
lng, chng loi ch phm mu;
c) Thc hin cc quy nh c lin quan n trch nhim ca n v pht
mu c quy nh ti Thng t ny.
3. Khoa, phng iu tr thc hin truyn mu lm sng:
a) Thc hin cc quy nh hin hnh v ch o ca gim c c s khm
bnh, cha bnh trong vic thc hin cc cng vic c lin quan quy nh ti
Khon 1 iu ny;
b) Chun b phng tin, dng c, thuc d phng cp cu thc hin
truyn mu v x tr kp thi khi xy ra tai bin;
c) Gii thch cho ngi bnh hoc ngi nh ca ngi bnh v li ch v
nguy c c th xy ra do truyn mu. Trong trng hp khng th gii thch cho
ngi bnh v ngi nh th phi ghi r l do vo bnh n;
50
Chng XI
IU KHON THI HNH
iu 70. L trnh thc hin
Vic thc hin xt nghim sng lc HIV-1, HIV-2, vi rt vim gan B v vi
rt vim gan C bng k thut NAT quy nh ti im g Khon 4 iu 14 Thng t
ny v xt nghim sng lc khng th bt thng quy nh ti im c Khon 4
iu 14 Thng t ny c thc hin theo l trnh nh sau:
a) Cc c s truyn mu trn a bn thnh ph H Ni, tnh Tha Thin Hu, thnh ph H Ch Minh v thnh ph Cn Th phi thc hin trc ngy 01
thng 01 nm 2015;
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KT. B TRNG
TH TRNG
Nguyn Th Xuyn
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