You are on page 1of 53

B Y T

CNG HA X HI CH NGHA VIT NAM


c lp - T do - Hnh phc

S: 26/2013/TT- BYT

H Ni, ngy 16 thng 9 nm 2013

THNG T
Hng dn hot ng truyn mu

Cn c Ngh nh s 63/2012/N-CP ngy 31 thng 8 nm 2012 ca Chnh


ph quy nh chc nng, nhim v, quyn hn v c cu t chc ca B Y t;
Theo ngh ca Cc trng Cc Qun l Khm, cha bnh v V trng
V Php ch;
B trng B Y t ban hnh Thng t hng dn hot ng truyn mu.
Chng I
QUY NH CHUNG
iu 1. Phm vi iu chnh
1. Thng t ny hng dn hot ng chuyn mn, k thut truyn mu,
bao gm: tuyn chn ngi hin mu, ly mu, xt nghim, iu ch, bo qun,
vn chuyn, qun l, s dng mu v ch phm mu trong iu tr; gim st nguy
c trong truyn mu; Hi ng truyn mu ti c s khm bnh, cha bnh; lu
gi h s v ch bo co.
2. Thng t ny khng iu chnh cc hot ng tuyn truyn, vn ng
hin mu; cc sn phm c tch chit t huyt tng, khng th n dng,
protein ti t hp; ghp m, b phn c th ngi v t bo gc.
iu 2. Gii thch t ng
Trong Thng t ny, cc t ng di y c hiu nh sau:
1. Ngi hin mu l ngi iu kin hin mu theo quy nh ti Thng
t ny v t nguyn hin mu ton phn hoc mt s thnh phn mu.

2. Thnh phn mu l mt hoc mt s loi t bo mu v hoc huyt


tng c ly trc tip t ngi hin mu bng gn tch v c chng ng.
3. Mu ton phn l mu c ly t tnh mch ngi hin mu c cha
cc loi t bo mu, huyt tng v c chng ng.
4. Gn tch (apheresis) thnh phn mu l k thut ly mt hoc nhiu
thnh phn mu trc tip t ngi hin thnh phn mu.
5. Ch phm mu l sn phm c iu ch ti c s truyn mu, gm
mt hoc nhiu loi t bo mu, huyt tng c ngun gc t mu ton phn hoc
thnh phn mu.
6. Ti mu (n v mu) l mt th tch mu hoc ch phm mu c
ng trong ti ring bit.
7. Phng cch xt nghim l trnh t thc hin cc xt nghim vi mt t
hp cc loi sinh phm c th c la chn theo tng mc ch xt nghim.
8. iu ch trong h thng kn l vic s dng k thut to ra ch phm
mu, trong n v mu c ng trong b ti gm nhiu ti gn sn vi nhau,
khng ct ni hoc vic ct ni dy cc ti mu c thc hin bng thit b ct
ni t ng v trng.
9. Pool l vic trn cc ch phm mu cng loi t nhiu n v mu, nhm
chun b mu xt nghim hoc bo m liu iu tr.
iu 3. Nguyn tc thc hin hot ng truyn mu
1. V mc ch nhn o, khng v mc ch li nhun.
2. Bo m t nguyn i vi ngi hin mu; khng p buc ngi khc
hin mu, thnh phn mu.
3. Ch s dng mu v cc ch phm mu phc v cha bnh, o to,
nghin cu khoa hc.
4. Gi b mt cc thng tin c lin quan n ngi hin mu, ngi nhn
mu v ch phm mu.
5. Bo m an ton cho ngi hin mu, ngi bnh c truyn mu, ch
phm mu v nhn vin y t c lin quan.
6. Thc hin truyn mu hp l i vi ngi bnh.

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

- Nhp tim u, tn s trong khong t 60 ln n 90 ln/pht;


- Khng c mt trong cc biu hin sau: gy, st cn nhanh (trn 10% cn
nng c th trong thi gian 6 thng); da xanh, nim mc nht; hoa mt, chng mt;
v m hi trm; hch to xut hin nhiu ni; st; ph; ho, kh th; tiu chy; xut
huyt cc loi; c cc tn thng, du hiu bt thng trn da.
) Xt nghim:
- i vi ngi hin mu ton phn v hin cc thnh phn mu bng gn
tch: nng hemoglobin phi t t nht bng 120 g/l; nu hin mu ton phn
th tch trn 350 ml phi t t nht 125 g/l.
- i vi ngi hin huyt tng bng gn tch: nng protein huyt
thanh ton phn phi t t nht bng 60g/l v c xt nghim trong thi gian
khng qu 01 thng;
- i vi ngi hin tiu cu, bch cu ht, t bo gc bng gn tch: s
lng tiu cu phi ln hn hoc bng 150109/l.
3. Ngoi cc tiu chun quy nh ti Khon 1, Khon 2 iu ny, vic c
hin mu do bc s khm tuyn chn ngi hin mu xem xt, quyt nh.
iu 5. Tr hon hin mu
1. Nhng ngi phi tr hon hin mu trong 12 thng k t thi im:
a) Phc hi hon ton sau cc can thip ngoi khoa;
b) Khi bnh sau khi mc mt trong cc bnh st rt, giang mai, lao, un
vn, vim no, vim mng no;
c) Kt thc t tim vc xin phng bnh di sau khi b ng vt cn hoc
tim, truyn mu, ch phm mu v cc ch phm sinh hc ngun gc t mu;
d) Sinh con hoc chm dt thai nghn.
2. Nhng ngi phi tr hon hin mu trong 06 thng k t thi im:
a) Xm tr trn da;
b) Bm di tai, bm mi, bm rn hoc cc v tr khc ca c th;
c) Phi nhim vi mu v dch c th t ngi c nguy c hoc nhim
cc bnh ly truyn qua ng mu;
d) Khi bnh sau khi mc mt trong cc bnh thng hn, nhim trng huyt,
b rn cn, vim tc ng mch, vim tc tnh mch, vim tu xng, vim ty.

3. Nhng ng phi tr hon hin mu trong 04 tun k t thi im:


a) Khi bnh sau khi mc mt trong cc bnh vim d dy rut, vim
ng tit niu, vim da nhim trng, vim ph qun, vim phi, si, ho g, quai
b, st xut huyt, kit l, rubella, t, quai b;
b) Kt thc t tim vc xin phng rubella, si, thng hn, t, quai b,
thy u, BCG.
4. Nhng ng phi tr hon hin mu trong 07 ngy k t thi im:
a) Khi bnh sau khi mc mt trong cc bnh cm, cm lnh, d ng mi
hng, vim hng, au na u Migraine;
b) Tim cc loi vc xin, tr cc loi c quy nh ti im c Khon 1
v im b Khon 3 iu ny.
5. Mt s quy nh lin quan n ngh nghip v hot ng c th ca
ngi hin mu: nhng ngi lm mt s cng vic v thc hin cc hot ng
c th sau y ch hin mu trong ngy ngh hoc ch c thc hin cc cng
vic hoc hot ng ny sau khi hin mu ti thiu 12 gi:
a) Ngi lm vic trn cao hoc di su: phi cng, li cn cu, cng
nhn lm vic trn cao, ngi leo ni, th m, thy th, th ln;
b) Ngi vn hnh cc phng tin giao thng cng cng: li xe but, li
tu ho, li tu thu;
c) Cc trng hp khc: vn ng vin chuyn nghip, ngi vn ng
nng, tp luyn nng.
6. i vi cc trng hp khng thuc quy nh ti cc khon 1, 2, 3, 4 v
5 iu ny, vic tr hon hin mu do bc s khm tuyn chn ngi hin mu
xem xt v quyt nh.
iu 6. Khong thi gian ti thiu gia cc ln hin mu v cc thnh
phn mu
1. Khong thi gian ti thiu gia hai ln lin tip hin mu ton phn hoc
khi hng cu bng gn tch l 12 tun.
2. Khong thi gian ti thiu gia hai ln lin tip hin huyt tng hoc
hin tiu cu bng gn tch l 02 tun.
3. Hin bch cu ht trung tnh hoc hin t bo gc bng gn tch mu
ngoi vi ti a khng qu ba ln trong 07 ngy.
5

4. Trng hp xen k hin mu ton phn v hin cc thnh phn mu khc


nhau cng mt ngi hin mu th khong thi gian ti thiu gia cc ln hin
c xem xt theo loi thnh phn mu hin trong ln gn nht.
Mc 2
KHM TUYN CHN NGI NG K HIN MU
V VIC LY MU, THNH PHN MU
iu 7. ng k v qun l thng tin hin mu, thnh phn mu
1. Ngi hin mu, thnh phn mu phi xut trnh mt trong cc loi giy
t sau: giy chng minh nhn dn, h chiu, giy chng minh qun i, cng an,
giy php li xe, th cng tc, th hc sinh, sinh vin hoc giy xc nhn nhn thn
do c quan, t chc, on th, chnh quyn a phng cp.
2. Ngi ng k hin mu, thnh phn mu phi in y thng tin vo
Bng hi tnh trng sc khe ngi hin mu c quy nh ti Ph lc 2 ban hnh
km theo Thng t ny.
3. Cc c s tip nhn mu phi t chc qun l thng tin ngi hin mu
theo mu h s qun l c quy nh ti Ph lc 3 ban hnh km theo Thng t
ny. Cc thng tin c nhn v ngi hin mu phi c bo mt, ch c s dng
vi mc ch bo m sc khe ngi hin mu v phng nga ly truyn bnh cho
ngi bnh nhn mu.
iu 8. Ni dung khm tuyn chn ngi hin mu
1. Thc hin vic hi tin s, khm sc kho v lm cc xt nghim theo
quy nh ti iu 4 Thng t ny.
2. Thc hin xt nghim nhanh HBsAg trc khi hin mu i vi ngi
ng k hin mu ln u.
3. Khng bt buc thc hin xt nghim nhanh HBsAg khi khm tuyn
chn i vi ngi ng k hin mu nhc li c kt qu xt nghim HBsAg
sng lc n v mu ln hin trc gn nht khng phn ng hoc c kt qu xt
nghim HBsAg m tnh trong ln khm sc khe gn nht trong thi gian 12 thng
tnh n ngy ng k hin mu, tr trng hp quy nh ti iu 15 Thng t ny.
4. Trng hp ngi c tin s nghi ng HBsAg dng tnh mun hin
mu, phi c kt qu m tnh trong hai ln xt nghim HBsAg lin tip cch nhau
06 thng bng k thut ELISA hoc ha pht quang v ng thi thc hin xt
nghim bng k thut sinh hc phn t.

iu 9. Vic ly mu ton phn, thnh phn mu


1. Trc khi ly mu, thnh phn mu phi kim tra, i chiu chng loi,
hn s dng, s nguyn vn v thnh phn chng ng ca ti ly mu (bao b
ng mu).
2. Ti ly mu phi c gn m s theo quy nh ti Khon 3 iu 21
Thng t ny.
3. Vic ly mu phi bo m v trng, an ton cho ngi hin mu.
4. Th tch mu ly theo quy nh ti im a v im b Khon 2 iu 4
Thng t ny v phi ph hp vi lng dung dch chng ng c sn trong ti ly
mu.
5. Bo m truy nguyn c cc thng tin lin quan n n v mu,
thnh phn mu: m s, th tch mu thc t, thi im, thi gian, tn nhn vin
ly mu, thnh phn mu.
6. Trng hp th tch mu ly t hoc nhiu hn 10% so vi quy nh cho
mi loi ti ly mu hoc c cc bt thng khc trong qu trnh ly mu, nhn
vin ly mu phi ghi cnh bo trn ti mu bng bt mc bn mu hoc dn nhn
ring xem xt v x l.
iu 10. Yu cu i vi vic ly mu mu xt nghim
1. Cc mu mu dng cho cc xt nghim phi c ly t ngi hin mu
cng thi im ly mu hoc thnh phn mu hoc ly trc tip t ti mu, ti
thnh phn mu.
2. Mu mu phi c gn m s tng ng vi m s ca ti mu, thnh
phn mu c ly theo quy nh ti Khon 2 iu 9 Thng t ny.
iu 11. X l n v mu, thnh phn mu ngay sau ly mu
Cc n v mu, thnh phn mu phi c ng gi, vn chuyn trong
iu kin nhit ph hp vi mc ch s dng theo quy nh ti iu 20 Thng
t ny.
Mc 3
BO M QUYN LI CA NGI HIN MU
iu 12. Quyn li ca ngi hin mu
1. c cung cp thng tin v cc du hiu, triu chng bnh l do nhim
cc vi rt vim gan, HIV v mt s bnh ly truyn qua ng mu khc.

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

b) C th truy tm ti mu t mu mu v ngc li truy tm mu mu t


ti mu;
c) Thc hin xt nghim theo phng cch bo m nhy, phng nga
nguy c m tnh gi v c lnh o n v ph duyt;
d) Kt qu xt nghim sng lc cc tc nhn ly truyn qua ng mu cho
n v mu, thnh phn mu ch c dng kim sot an ton cho n v mu,
thnh phn mu nhm phng nga ly nhim cc tc nhn ly truyn qua ng
mu v khng c s dng tr li, t vn cho ngi hin mu.
5. Khi ly mu t ngi hin mu nhiu ln cng c s ly mu, phi i
chiu vi kt qu xt nghim ca n v mu hin ln gn nht trc . Trng
hp cc kt qu xt nghim c s khc nhau hoc nghi ng nhm ln mu xt
nghim hoc nhm ln h s, phi xt nghim li vi mu ly trc tip t n v
mu, thnh phn mu.
6. Khi thc hin xt nghim khng nh v cc tc nhn ly truyn qua
ng mu cho ngi hin mu phi bo m cc yu cu sau:
a) Xc minh chnh xc nhn thn ngi c ly mu lm xt nghim;
b) Thc hin xt nghim theo phng cch bo m c hiu, phng
nga nguy c dng tnh gi v c cp c thm quyn ph duyt;
c) Kt qu xt nghim khng nh ch c dng tr li, t vn sc khe
cho ngi hin mu v khng c dng kim sot an ton cc n v mu,
thnh phn mu.
iu 14. Cc loi xt nghim sng lc n v mu
1. Cc xt nghim bt buc phi thc hin i vi tt c n v mu ton
phn, thnh phn mu hin gm:
a) Xet nghim huyt thanh hc nhom mau: inh nhm hng cu ABO,
Rh(D), sng lc khng th bt thng;
b) Xet nghim mt s tac nhn ly truyn bnh: xt nghim sng lc HIV,
vim gan vi rt B, vim gan vi rt C v giang mai.
2. Ngoi cc xt nghim quy nh ti Khon 1 iu ny, phi thc hin
thm mt s xt nghim trong cc trng hp sau:
a) Xt nghim sng lc st rt i vi cc n v mu ton phn, thnh
phn mu ly t ngi hin mu ang sng, lm vic nhng vng c lu hnh
dch st rt theo cng b ca B Y t hoc nhng ngi mi tr v t vng dch
9

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

c y quyn v vic khng c n v mu ph hp lu tr ti c s khm bnh,


cha bnh hoc khng so vi nhu cu iu tr v ghi h s bnh n xc nhn vic
cho php thc hin xt nghim nhanh ti thi im cn phi truyn mu cp cu.
2. Trong trng hp p dng cc quy nh ti Khon 1 iu ny v vic xt
nghim n v mu bng phng php xt nghim nhanh, cc c s khm bnh,
cha bnh phi thc hin nh sau:
a) Chm nht l 24 gi k t thi im thc hin truyn n v mu ch
sng lc bng phng php xt nghim nhanh, c s khm bnh, cha bnh phi
tip tc thc hin y cc xt nghim quy nh ti iu 14 Thng t ny v
phi lu mu xt nghim theo quy nh ti iu 16 Thng t ny;
b) Trong trng hp khng c kh nng thc hin cc xt nghim theo quy
nh ti iu 14 v im a Khon 2 iu ny, c s khm bnh, cha bnh phi gi
mu huyt thanh, huyt tng ca n v mu truyn n c s khc c kh nng
thc hin xt nghim theo quy nh ti iu 14 Thng t ny trong thi gian chm
nht l 07 ngy k t thi im thc hin truyn mu ch sng lc bng phng
php xt nghim nhanh; phi lu mu huyt thanh ca n v mu truyn ti c
s thc hin xt nghim sng lc theo quy nh ti iu 16 Thng t ny.
3. C s khm bnh, cha bnh min ni, vng su, vng xa, bin gii v
hi o khng c kh nng thc hin xt nghim theo quy nh ti iu 14 Thng
t ny v cng khng th gi n cc c s khc lm xt nghim theo quy nh ti
Khon 2 iu ny, c s dng n v mu sng lc bng phng php xt
nghim nhanh, khi p ng cc iu kin sau:
a) Ngi hin mu c xt nghim sng lc theo quy nh ca iu 14
Thng t ny trong thi gian khng qu 12 thng tnh n thi im hin mu vi
cc phiu tr li kt qu xt nghim phi m tnh v c lu tr ti c s tip
nhn hin mu;
b) n v mu hin phi c lm xt nghim nhanh sng lc HIV, vim
gan vi rt B, vim gan vi rt C vi kt qu cc xt nghim u phi m tnh.
iu 16. Lu gi mu xt nghim
1. Phi lu gi mu huyt thanh hoc huyt tng dng xt nghim
sng lc tt c cc n v mu ton phn, thnh phn mu.
2. Mu xt nghim phi c bo qun nhit t m 18 oC (- 18oC) tr
xung, c m ha v lp h s qun l.
3. Mu xt nghim phi c lu gi ti c s thc hin xt nghim ti
thiu 02 nm k t ngy ly mu. i vi n v mu, ch phm mu c thi hn
12

s dng di hn 02 nm k t khi ly mu, th thi gian lu gi mu xt nghim


phi ko di thm ti thiu 01 nm tnh t thi im ht hn s dng cc n v
mu, ch phm mu . B phn (t, nhm, khoa, phng) lu mu huyt thanh,
huyt tng phi c lp vi b phn lm xt nghim.
iu 17. Qun l kt qu xt nghim
1. Sau khi c kt qu xt nghim, b phn xt nghim phi c trch nhim
thng bo kt qu bng vn bn hoc truyn d liu in t theo cch thc c
lnh o n v ph duyt cho cc b phn c lin quan.
2. Nu cc xt nghim sng lc n v mu v tc nhn gy bnh ly qua
ng mu c kt qu bt thng, th thc hin theo quy nh ti Khon 4 Ph lc
6 ban hnh km Thng t ny.
3. Trng hp xt nghim n v mu, thnh phn mu ly t ngi hin
mu nhc li c kt qu bt thng v cc tc nhn gy bnh ly qua ng mu,
b phn xt nghim sng lc n v mu phi xt nghim li mu mu t n v
mu, thnh phn mu ca cng ngi hin mu ln hin mu trc; nu kt qu
xt nghim li ln hin trc c bt thng th tip tc kim tra li mu ly ln
hin trc lin k, ng thi b phn xt nghim c trch nhim phi thng bo
cho cc b phn, n v lin quan bit cng thc hin theo quy nh ti Ph lc
7 ban hnh km theo Thng t ny. Vic xt nghim cho cc mu mu ca cc ln
hin trc phi s dng k thut v sinh phm c nhy cao t nht bng hoc
tng ng vi k thut v sinh phm thc hin ln trc.
4. Ch c thng bo kt qu bt thng cho ngi hin mu khi thc
hin xt nghim khng nh theo Ph lc 6 ban hnh km Thng t ny. Trong
trng hp xt nghim khng nh v HIV, phi thc hin theo quy nh hin hnh
ca B Y t v vic thng bo kt qu xt nghim HIV dng tnh.

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

2. Thc hin tch cc ch phm mu trong h thng kn hoc trng hp


iu ch trong h thng h phi bo m thc hin quy trnh v trng.
3. ng lnh v tan ng cc ch phm huyt tng v ta lnh
a) n v huyt tng phi c ng lnh trong khong thi gian ti a 8
gi k t thi im bt u vic ng lnh vi nhit t m 25 oC (-25oC) tr
xung;
b) Bo qun ng lnh: phi bo qun nhit duy tr t m 18oC
18oC) tr xung;

(-

c) Lm tan ng, m ti mu, ch phm mu phi bo m cc iu kin


sau:
- Khng b mt ti mu, cc v tr cm kim truyn mu tip xc trc tip
vi dung dch lm tan ng;
- Lm tan ng nhit t 30 oC n 37oC trong thi gian khng qu 15
pht i vi ch phm ta lnh v khng qu 45 pht i vi huyt tng ng
lnh;
- n v mu, ch phm mu c lm tan ng th khng c lm
ng lnh li.
4. Chiu x gamma cho ti mu v ch phm mu
a) Phi chiu x gamma cho ti mu v ch phm mu bt hot bch cu
lympho phng nga nguy c bnh ghp chng ch trc khi truyn cho ngi
bnh mc chng suy gim min dch, vi liu chiu x cho mi lt chiu phi t
t nht 25 Gy (2.500 cGy);
b) Hn dng ca khi hng cu sau khi chiu x l 28 ngy v ng thi
phi tun th hn dng ca khi hng cu khng chiu x cng loi, cng thi
gian. Hn s dng khi tiu cu khng thay i sau chiu x;
c) Phi dn nhn phn bit ti mu c chiu x vi ti mu cha
chiu x.
5. Cch ly v tiu hy n v mu:
a) n v mu, thnh phn mu v ton b cc n v ch phm mu cha
c xt nghim theo quy nh ti cc iu 14, iu 15 Thng t ny phi c
cch ly, bo qun ring bit cho n khi p ng iu kin. Phng cch x l
cc n v mu, thnh phn mu c kt qu xt nghim bt thng thc hin theo
quy nh ti Ph lc 6 ban hnh km Thng t ny.
14

b) Tt c cc n v mu, ch phm mu khng an ton hoc ht hn s


dng phi c cch ly, qun l ring bit v tiu hy theo quy nh hin hnh v
qun l cht thi y t.
iu 19. Thit b lnh bo qun cc n v mu v ch phm mu
1. Yu cu chung v thit b lnh bo qun n v mu v ch phm mu
a) Phng t thit b lnh bo qun mu phi c bo m c in p n
nh v thng kh tt;
b) Thit b lnh c khong trng trong khoang bo qun bo m lu
thng dng kh, d kim tra v quan st;
c) Nhit ng u mi v tr bn trong khoang bo qun;
d) Thit b lnh phi c h thng theo di nhit p ng cc yu cu sau:
- C kh nng gim st nhit ng thi bng hai phng php c lp,
lin tc v lu li c thng s theo thi gian thc t bng h thng ghi nhit
t ng hoc ghi th cng t nht 4 gi mt ln;
- H thng gim st nhit ca thit b lnh phi hot ng c trong
trng hp mt in ngun;
- C h thng cnh bo nhit bt thng bng m thanh, nh sng.
) Thit b lnh bo qun n v mu, ch phm mu khng c dng
bo qun cc thuc th, sinh phm xt nghim, thc phm;
e) C ch bo qun ring, c nhn phn bit cho tng loi mu, ch phm
mu nh sau:
- Loi xt nghim an ton sn sng cp pht;
- Loi cha xt nghim;
- Loi xt nghim v c kt qu bt thng.
2. Yu cu i vi t lnh bo qun n v mu, ch phm mu
a) Nhit bn trong khoang bo qun lun t 2oC n 6oC;
b) Bo m s ng u nhit ca khoang bo qun bng thng gi cng
bc vi qut thng gi;
c) Cho php quan st c cc ti mu lu tr bn trong khoang bo qun,
m khng cn m cnh t.
15

3. Yu cu i vi quy ng lnh bo qun n v mu, ch phm mu


a) Nhit bn trong khoang bo qun lun c nhit t m 18 oC
(-18oC) tr xung tu theo yu cu bo qun ca loi ch phm mu v quy trnh
c ph duyt;
b) C kh nng nh k t ph ng dn lnh hoc phi nh k ph ng
th cng bm dnh dn lnh.
4. Yu cu i vi my lc v t bo qun tiu cu
a) Nhit bn trong khoang bo qun lun t 20oC n 24oC;
b) Bo m s ng u nhit trong t bng thng gi cng bc vi
qut thng gi;
c) Quan st c cc ti tiu cu lu tr bn trong khoang bo qun, m
khng cn m cnh t;
d) My lc theo chiu ngang;
) C h thng bo ng khi my lc dng hot ng hoc c nhng bt
thng.
iu 20. Vn chuyn mu v ch phm mu
1. Thit b, phng tin vn chuyn phi duy tr c nhit ph hp vi
yu cu bo qun tng loi mu v ch phm mu.
2. Vic vn chuyn n v mu phi bo m an ton, kim sot, theo di
c nhit v thi gian vn chuyn theo yu cu sau:
a) i vi mu ton phn v khi hng cu: bo m duy tr nhit trong
khoang vn chuyn t 1oC n 10oC trong sut qu trnh vn chuyn; mu ton
phn dng iu ch khi tiu cu c bo qun, vn chuyn theo quy nh ti
im b Khon 2 iu 22 Thng t ny;
b) i vi khi tiu cu v khi bch cu: bo m duy tr nhit trong
khoang vn chuyn t 20oC n 24oC;
c) i vi huyt tng v cc ch phm mu ng lnh: bo m duy tr
nhit trong khoang vn chuyn t m 18oC (-18oC) tr xung;
d) lnh dng bo qun khng c t tip xc trc tip vi ti mu.
iu 21. Nhn ca n v mu v ch phm mu
Ngoi vic tun th cc quy nh hin hnh v ghi nhn hng ha, nhn ca
n v mu, ch phm mu phi c nhng thng tin nh sau:
16

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;

18

c) Lng hemoglobin ti thiu l 10g t mi th tch 100ml mu ton phn


c iu ch;
d) Hematocrit t 0,50 n 0,70;
3. iu kin bo qun v hn s dng:
a) i vi khi hng cu c dung dch bo qun c iu ch trong h
thng kn: hn s dng thc hin theo khuyn ngh ca nh sn xut ti ly mu v
dung dch bo qun mu, nhng khng ko di hn 42 ngy k t thi im ly
mu v bo qun nhit t 2oC n 6oC;
b) i vi khi hng cu c dung dch bo qun c iu ch trong h
thng h: ch c s dng trong khong thi gian khng qu 24 gi nu bo qun
nhit t 2oC n 6oC v khng qu 6 gi nu bo qun nhit phng (t
18oC n 24oC) k t khi thc hin iu ch trong h thng h.
iu 25. Khi hng cu gim bch cu
1. Khi hng cu gim bch cu l khi hng cu c tch bch cu bng
phng php ly tm loi b trn 70% bch cu c trong n v mu ton phn ban
u.
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 70% 15% th tch mu ton phn
ban u;
b) Lng hemoglobin ti thiu l 9,5g t mi 100 ml mu ton phn;
c) Hematocrit t 0,50 n 0,70;
d) S lng bch cu cn li t hn 1,2109 t mi n v khi hng cu gim
bch cu. C t nht 75% s n v mu c kim tra phi t tiu chun ny;
3. iu kin bo qun v hn s dng: Khi hng cu gim bch cu c
bo qun theo quy nh ti Khon 3 iu 24 Thng t ny.
4. Khi hng cu gim bch cu c dung dch bo qun: theo quy nh ti
Khon 2 iu ny v iu 24 Thng t ny.
iu 26. Khi hng cu ra
1. Khi hng cu ra l khi hng cu c loi b huyt tng bng cch
ra nhiu ln (ti thiu 3 ln) vi dung dch mui ng trng v c pha long
19

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

iu 28. Khi hng cu ng lnh


1. Khi hng cu ng lnh l khi hng cu c bo qun ng lnh trong
dung dch bo v hng cu ng lnh c glycerol v c bo qun nhit t
m 60oC (-60oC) tr xung. Trc khi c truyn cho ngi bnh, khi hng cu
ng lnh phi c lm tan ng, ra v loi b glycerol, ha long trong dung
dch mui ng trng hoc b sung dung dch bo qun hng cu.
2. Tiu chun v kim tra cht lng
Thc hin kim tra cht lng (vi s lng mu ly ngu nhin ti thiu
10% tng s n v khi hng cu ng lnh lm tan ng v loi b glycerol)
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 8,0g t mi 100ml mu ton phn ban u;
c) Hematocrit t 0,50 n 0,75;
d) thm thu ti a khng cao hn 340 mOsm/l;
) Nui cy pht hin vi khun m tnh.
3. iu kin bo qun v hn s dng:
a) Hn s dng l 10 nm bo qun vi dung dch glycerol 40% nhit
t m 80oC (-80oC) n m 60oC (-60oC);
b) Hn s dng l 10 nm bo qun vi dung dch glycerol 20% trong nit
lng nhit t m 150oC (-150oC) n m 120oC (-120oC);
c) Hn s dng l 14 ngy tnh t ngy lm tan ng, ra hng cu loi b
glycerol trong h thng kn v c b sung dung dch bo qun hng cu;
d) Hn s dng khng qu 24 gi nu bo qun t 2 oC n 6oC v khng
qu 6 gi nu bo qun nhit phng k t khi lm tan ng v ra hng cu
loi b glycerol trong h thng h.
iu 29. Khi tiu cu iu ch t n v mu ton phn
1. Khi tiu cu cha phn ln tiu cu c iu ch t n v mu ton
phn bo qun nhit t 20oC n 24oC trong 24 gi k t khi ly mu.
2. Tiu chun v kim tra cht lng khi tiu cu iu ch t mt n v
mu ton phn.

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

4. iu kin bo qun v hn s dng


a) i vi khi tiu cu iu ch t n v mu ton phn trong h thng
kn: hn s dng theo khuyn ngh ca nh sn xut ti ly mu, nhng khng qu
05 ngy k t ngy ly mu v bo qun tiu cu nhit t 20 oC n 24oC km
theo lc lin tc;
b) i vi khi tiu cu iu ch t n v mu ton phn trong h thng
h: hn s dng khng qu 06 gi, k t khi kt thc iu ch khi bo qun nhit
t 20oC n 24oC km theo lc lin tc.
iu 30. Khi tiu cu gn tch t ngi hin mu
1. Khi tiu cu gn tch l khi tiu cu ly trc tip t ngi hin mu
bng my tch t bo t ng.
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 gn tch) v cc tiu chun sau:
a) Th tch mi n v khng dao ng qu 15% th tch ghi trn nhn;
b) Mi n v khi tiu cu gn tch (250 ml) c s lng tiu cu ti thiu
300109; trong trng hp khi tiu cu gn tch c th tch 120 ml n di 250
ml c s lng tiu cu ti thiu 150109;
c) Nng tiu cu phi thp hn 1,5109/ml;
d) pH phi t t 6,4 n 7,4 vo cui thi gian bo qun.
3. iu kin bo qun v hn s dng: theo khuyn ngh ca nh sn xut ti
ly tiu cu, nhng khng qu 5 ngy k t ngy gn tch tiu cu khi bo qun
nhit t 20oC n 24oC, km lc lin tc.
iu 31. Khi tiu cu lc bch cu
1. Khi tiu cu lc bch cu l khi tiu cu c iu ch t mu ton
phn hoc bng gn tch v c loi b bch cu bng b lc bch cu.
2. Tiu chun v kim tra cht lng: kim tra cht lng cc n v khi
tiu cu lc bch cu
a) Th tch mi n v dao ng khng qu 15% (15%) th tch ghi trn
nhn;
b) Khi tiu cu lc bch cu c iu ch t mu ton phn: c t nht
130109 tiu cu trong n v khi tiu cu iu ch t mi 1.000 ml mu ton
phn;
23

c) Khi tiu cu lc bch cu gn tch t ngi hin mu: c t nht 30010 9


tiu cu vi mi lt gn tch tiu cu;
d) C t hn 1106 bch cu trong mt n v khi tiu cu;
) pH phi t t 6,4 n 7,4 vo cui thi gian bo qun;
e) Nui cy pht hin vi khun m tnh: kim tra tiu chun ny trong t nht
t 1% n 5% s n v iu ch. Khng cn kim tra tiu chun ny vi khi
tiu cu lc bch cu ngay ti ging bnh.
3. iu kin bo qun v hn s dng:
a) i vi khi tiu cu iu ch trong h thng kn: hn s dng theo
khuyn ngh ca nh sn xut ti ly mu, nhng khng qu 05 ngy k t ngy
ly mu v bo qun tiu cu nhit t 20oC n 24oC km theo lc lin tc;
b) i vi khi tiu cu iu ch trong h thng h: hn s dng khng qu
06 gi, k t khi kt thc iu ch khi bo qun nhit t 20 oC n 24oC km
theo lc lin tc.
iu 32. Huyt tng v huyt tng ng lnh
1. Huyt tng l phn dch lng khng cha cc t bo mu, c iu ch
t n v mu ton phn hoc ly trc tip t ngi hin huyt tng bng gn
tch. Huyt tng c th c s dng ngay sau iu ch hoc c ng lnh
(gi l huyt tng ng lnh) theo quy nh ti Khon 4 iu 18 Thng t ny.
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 cc n v c iu
ch v khng thp hn 05 n v mi thng) v cc tiu chun sau:
a) Nng protein khng thp hn 50 g/l;
b) Th tch huyt tng chnh lch khng qu 10% th tch ghi trn nhn.
3. iu kin bo qun v hn s dng
a) Bo qun nhit t 2 o C n 6 o C: hn s dng ca huyt tng l
khng qu 14 ngy k t thi im iu ch trong h thng kn v khng qu 24
gi k t thi im iu ch trong h thng h;
b) Bo qun nhit t m 18 oC (-18oC) n m 25oC (-25oC): hn s
dng ca huyt tng khng qu 12 thng k t thi im ly mu hoc gn tch
huyt tng;

24

c) Bo qun nhit t m 25oC (-25oC) tr xung: hn s dng ca huyt


tng khng qu 24 thng k t thi im ly mu hoc gn tch huyt tng.
d) Khng c ng lnh li huyt tng lm tan ng.
iu 33. Huyt tng ti v huyt tng ti ng lnh
1. Huyt tng ti l huyt tng c nng cc yu t ng mu khng
bn vng duy tr nng sinh l, c iu ch t mu ton phn hoc ly trc
tip t ngi hin mu bng phng php gn tch.
2. Huyt tng ti ng lnh l huyt tng c quy nh ti Khon 1
iu ny v c lm ng lnh huyt tng trong khong thi gian ti a l 18
gi k t khi ly mu hoc gn tch huyt tng. Vic lm ng lnh huyt tng
phi thc hin theo quy nh ti Khon 4 iu 18 Thng t ny.
3. Tiu chun v kim tra cht lng i vi huyt tng ti v huyt
tng ti ng lnh: 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 thp hn
05 n v mi thng) v cc tiu chun sau:
a) Th tch huyt tng chnh lch khng qu 15% th tch ghi trn nhn;
b) Nng yu t VIII khng thp hn 0,7 IU (n v quc t)/ml. C t
nht 75% s mu c kim tra phi t tiu chun ny;
c) S lng t bo tn d: hng cu t hn 6,010 9/l, bch cu t hn
0,1109/l, tiu cu t hn 50109/l;
d) Nng protein ton phn khng thp hn 50g/l;
) Khng c mu sc bt thng, khng c vn, cc ng.
3. iu kin bo qun v hn s dng:
a) Bo qun nhit t m 18 oC (-18oC) n m 25oC (-25oC): hn s
dng ca huyt tng khng qu 12 thng k t thi im ly mu hoc gn tch
huyt tng;
b) Bo qun nhit t m 25oC (-25oC) tr xung: hn s dng ca huyt
tng khng qu 24 thng k t thi im ly mu hoc gn tch huyt tng;
c) i vi ch phm huyt tng ti v huyt tng ti ng lnh lm
tan ng:
- Bo qun nhit t 2oC n 6oC: phi s dng ngay trong vng 06 gi
25

tnh t thi im bt u lm tan ng; phi thay nhn ph hp (huyt


tng) nu bo qun trn 06 gi;
- Khng c ng lnh li huyt tng ti ng lnh lm tan ng.
iu 34. Ta lnh
1. Ta lnh l ch phm tch t phn ta hnh thnh trong qu trnh tan ng
huyt tng ti ng lnh nhit t 10oC tr xung.
2. Tiu chun v kim tra cht lng: thc hin kim tra cht lng (vi s
lng mu ly ngu nhin t 0,1% n 1% tng s cc n v c iu ch v
khng thp hn 05 n v mi thng) v cc tiu chun sau:
a) Th tch t 10 ml n 25 ml cho mi n v ta lnh iu ch t mt n
v mu ton phn c th tch ln hn hoc bng 250 ml. Th tch t 80 ml n 120
ml cho mi pool ta lnh t 2.000 ml mu ton phn. Th tch ta lnh thc o
chnh lch khng qu 15% th tch ghi trn nhn.
b) Nng yu t VIII khng t hn 30 IU cho mi n v ta lnh iu ch
t mt n v mu ton phn c th tch ln hn hoc bng 250 ml v t nht 75%
s mu c kim tra t tiu chun ny;
c) Lng fibrinogen khng thp hn 75mg cho mi n v ta lnh iu ch
t mt n v mu ton phn c th tch ln hn hoc bng 250 ml v t nht 75%
s mu c kim tra t tiu chun ny;
d) Khng c mu sc bt thng, khng c vn, cc ng.
3. iu kin bo qun v hn s dng:
a) Bo qun nhit t m 18oC (-18oC) tr xung: hn s dng ca ta
lnh khng qu 12 thng;
b) Ta lnh lm tan ng:
- Khi bo qun nhit t 2 oC n 6oC phi s dng ngay ta lnh hoc
trong vng 06 gi tnh t thi im bt u lm tan ng;
- Khng c ng lnh li sau khi lm tan ng.
iu 35. Khi bch cu ht trung tnh
1. Khi bch ht trung tnh c gn tch trc tip t ngi hin mu hoc
iu ch t cc n v mu ton phn c bo qun nhit t 20 oC n 24oC
khng qu 24 gi k t thi im ly mu.

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

c) c b sung huyt tng ti ng lnh nhm AB hoc nhm khc ph


hp min dch vi nhm ca n v khi hng cu v nhm mu ca tr s sinh;
d) Ch phm bo qun nhit t 2 oC n 6oC v s dng trong vng 04
gi k t thi im c khi phc;
) Kim tra cht lng theo quy nh ti Khon 3 iu 22 Thng t ny v
hematocrit t t 0,40 n 0,50;
e) Mu ton phn khi phc s dng truyn thay mu cho tr s sinh,
c lc bch cu, chiu x trong trng hp cn thit theo ch nh ca bc s
iu tr lm sng.

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

iu 41. Kim tra hnh thc bn ngoi tui mu, ch phm mu


1. Phi kim tra hnh thc bn ngoi tu i mu v ch phm mu trong cc
trng hp sau:
a) Giao nhn gia cc b phn trong c s truyn mu;
b) Giao nhn gia c s cung cp mu v n v pht mu ca c s kham
bnh, cha bnh hoc gia cac n v pht mu ca cc c s kham bnh, cha
bnh vi nhau;
c) Giao nhn gia n v pht mu v n v iu tr ca cng c s khm
bnh, cha bnh.
2. Khng s dng cc n v mu v ch phm mu, khi pht hin thy cc
du hiu sau:
a) Thng, h, nt, v ti ng, ng dy, v tr cm dy truyn;
b) Hin tng khng phn lp hoc phn lp bt thng gia cc thnh
phn mu khi lng hoc ly tm;
c) C mu sc bt thng:
- Mu hng hoc phn trn mt phn cch huyt tng v hng cu
hoc ton b huyt tng;
- Huyt tng co mu sc bt thng;
- Phn hng cu i mu tm hoc en sm hoc mu sc bt thng khc.
d) C cc ng, vn, ta;
) C ni vng trn b mt.
iu 42. Yu cu i vi n v iu tr trc khi nhn mu, ch phm mu
1. Bc s iu tr cn nh gi tnh trng bnh l v pht hin sm nhu cu
cn truyn mu ngi bnh.
2. Bc s iu tr phai chi inh thc hin cc xt nghim cho ngi bnh c
d kin cn truyn mu:
a) nh nhm mu ABO, Rh(D);
b) Sng lc khng th bt thng cho nhng ngi bnh:
- C tin s truyn mu;
- Ph n c tin s cha, , xy thai nhiu ln;
- Nu trong qu trnh iu tr, ngi bnh cn truyn mu nhiu ln, nhiu
ngy phi lm li xt nghim ny nh k khng qu 7 ngy mt ln.
30

c) Trng hp xt nghim sng lc khng th bt thng cho kt qu


dng tnh, cn ch nh lm xt nghim nh danh khng th bt thng;
d) Trng hp ngi bnh c khng th bt thng c nh danh, cn
ch nh la chn n v mu ph hp, khng c cc khng nguyn tng ng vi
cc khng th c trong huyt thanh ca ngi bnh;
) Trng hp khng th nh danh khng th bt thng hoc khng tm
c n v mu ph hp, bc s iu tr phi phi hp vi n v pht mu
xem xt, quyt nh p dng bin php iu tr thch hp.
3. Ch nh truyn mu sau khi cn nhc li ch v nguy c ca truyn
mu i vi tng ngi bnh khi khng c liu php iu tr thay th khc, hoc
cc liu php iu tr thay th khng c hiu qu.
4. Bc s iu tr hoc iu dng vin phai thng bo cho ngi bnh
hoc ngi nh v li ch v nguy c c th xy ra do truyn mu. Trong trng
hp khn cp cn truyn mu ngay nhng khng th thng bo c do ngi
bnh b hn m, khng c ngi nh th bc s phi ghi r vi s xc nhn ca mt
nhn vin y t vo h s bnh n.
Ngi bnh hoc ngi nh ngi bnh phi xc nhn v k vo bnh n nu
t chi vic truyn mu, ch phm mu.
5. iu dng vin lp phiu d tr cung cp mu theo mu quy nh ti
Ph lc 9 ban hnh km theo Thng t ny v ly mu mu tnh mch ca ngi
bnh co chi inh truyn mau theo cc yu cu sau:
a) Khi ly mu mu phi kim tra ch nh truyn mu, tn, tui, m s
ngi bnh, khoa, s ging iu tr i chiu vi h s bnh n;
b) Mu mu ca ngi bnh phi ly vo 2 ng nghim vi th tch t 1 ml
n 2 ml mu c chng ng v 4 ml n 5 ml mu khng chng ng;
c) Ghi thng tin trn nhn ng nghim:
- H v tn hoc m s ca ngi bnh;
- Nm sinh ca ngi bnh;
- S ging, khoa phng iu tr.
d) Chuyn phiu d tr v cc mu mu cho n v pht mu;
iu 43. Xt nghim bo m ha hp min dch truyn mu
Khi nhn c phiu d tr v mu mu ngi bnh, nhn vin n v pht
mu phi thc hin cc cng vic sau:
31

1. Kim tra, i chiu thng tin mu mu vi phiu d tr. Trng hp


thng tin khng trng khp, th mu mu khng c dng nh nhm mu
v xt nghim ha hp.
2. nh nhm mu h ABO mu mu ngi bnh v n v mu:
a) nh nhm mu h ABO theo k thut trong ng nghim hoc cc k
thut khc c nhy cao hn;
b) Thc hin nh nhm mu ng thi bng hai phng php huyt thanh
mu v hng cu mu cho mu mu ngi bnh, n v mu ton phn v khi
bch cu ht. nh nhm mu bng phng php huyt thanh mu cho cc ch
phm hng cu. nh nhm mu bng phng php hng cu mu cho cc ch
phm huyt tng, ta lnh v tiu cu;
c) Vic nh nhm mu ngi bnh c thc hin hai ln trn cng mu
mu hoc hai mu mu ca cng mt ngi bnh. Trng hp cc kt qu ca hai
phng php nh nhm mu h ABO trong cng mt ln hoc ca cc ln nh
nhm mu khng ph hp vi nhau, phi thc hin cc xt nghim b sung
khng nh kt qu nh nhm mu;
d) nh nhm mu ABO ca tr s sinh v thai nhi: Ch thc hin nh
nhm mu bng phng php huyt thanh mu; khng nh nhm mu bng
phng php hng cu mu. Trong trng hp kt qu nh nhm mu khng r
rng, c th s dng cc xt nghim b sung khc khng nh. Nu khng th
xc nh c nhm mu, cn chn la ha hp min dch theo quy nh ti
Khon 1 iu 45 Thng t ny.
3. nh nhm mu h Rh(D) mu mu ngi bnh:
a) Khi c ch nh truyn n v mu ton phn, khi hng cu, khi tiu
cu v khi bch cu;
b) Thc hin nh nhm mu h Rh(D) bng k thut trong ng nghim
hoc cc k thut khc c nhy cao hn.
4. i chiu kt qu xt nghim sng lc v nh danh khng th bt
thng thc hin trc theo quy nh ti cc im b, c, d v Khon 2 iu
42 Thng t ny.
5. Thc hin xt nghim ha hp min dch truyn mu:
Thc hin xt nghim ho hp min dich trong ng nghim hoc bng cc
k thut c nhy cao hn trong nhng trng hp sau:
a) Truyn mu ton phn, khi hng cu cn nhiu huyt tng, khi bch cu:
- Xt nghim ho hp min dich mi trng nc mui sinh l, nhit
phng xt nghim 20oC n 24oC gm:
32

+ ng 1: Gm hng cu ca n v mu, ch phm mu vi huyt thanh


ngi nhn;
+ ng 2: Gm huyt tng ca n v mu, ch phm mu vi hng cu
ngi nhn.
- Xt nghim ho hp min dich nhit 37oC v c s dng huyt thanh
khng globulin (nghim php Coombs gin tip): Thc hin xt nghim ho hp
gia hng cu ca n v mu, khi hng cu, khi bch cu vi huyt thanh ca
ngi nhn bng phng php ng nghim nhit 37 oC v c s dng huyt
thanh khng globulin hoc k thut c nhy cao hn.
b) Truyn cc loi khi hng cu cn t hoc khng cn huyt tng:
- Xt nghim ho hp min dich mi trng nc mui sinh l, nhit
phng t 20oC n 24oC gia hng cu ca n v mu vi huyt thanh ngi nhn
(ng 1);
- Xt nghim ho hp min dich nhit 37oC v c s dng huyt thanh
khng globulin (nghim php Coombs gin tip): thc hin xt nghim ho hp
gia hng cu ca n v mu, khi hng cu, khi bch cu vi huyt thanh ca
ngi nhn bng phng php ng nghim nhit 37 oC v c s dng huyt
thanh khng globulin hoc k thut c nhy cao hn.
c) Truyn ch phm tiu cu, huyt tng: thc hin xt nghim ho hp
gia huyt tng ca n v ch phm mu vi hng cu ngi nhn trong ng
nghim (ng 2) mi trng nc mui sinh l, nhit phng t 20 oC n 24oC
hoc k thut c nhy cao hn;
d) Kt qua xet nghim hoa hp c coi la m tinh khi khng co hin
tng ngng kt, tan mu. Ch cp pht n v mu khi kt qua xet nghim hoa
hp la m tinh, tr trng hp truyn tua lanh theo quy inh tai Khoan 3 iu 44
Thng t ny;
) Khi kt qu cc xt nghim ho hp c hin tng ngng kt hoc tan
mu cn kim tra, i chiu h s, cc thng tin c lin quan v phi hp vi bc
s iu tr ch nh xt nghim thc hin cc yu cu quy nh ti cc im b, c,
d v Khon 2 iu 42 Thng t ny.
6. Sau khi hon thnh cc cng vic theo quy nh ti cc khon 2, 3, 4 v
5 iu ny, nhn vin n v pht mu lp h s cp pht mu nh sau:
a) Phiu truyn mu theo mu quy nh ti Ph lc 10 ban hnh km theo
Thng t ny, c gi cho n v iu tr s dng mu;
33

b) H s ghi kt qu nh nhm mu, xet nghim ho hp min dich v


c lu ti n v pht mu.
iu 44. La chn n v mu ho hp min dch
1. Truyn n v mu ton phn v khi hng cu ho hp nhm mu h
ABO vi ngi nhn, theo yu cu sau:
Nhm mu ngi bnh
nhn mu
O
A
B
AB

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

2. Truyn cc n v ch phm huyt tng ha hp nhm mu h ABO


vi ngi bnh nhn mu theo cc yu cu sau:
Nhm mu ngi bnh nhn mu

Nhm mu n v huyt tng truyn

O hoc B hoc A hoc AB

A hoc AB

B hoc AB

AB

AB

3. C th truyn ta lnh khng ho hp nhm h ABO cho ngi bnh


nhn mu vi liu lng truyn khng vt qu 10 ml/kg cn nng c th trong
khong thi gian 12 gi.
4. Chn la cc ch phm tiu cu v bch cu ht theo yu cu sau:
Nhm mu ngi
bnh nhn mu
O

Nhm mu ca n v mu, ch phm mu truyn


n v mu, ch phm
n v mu, ch phm
mu cn huyt tng
mu loi b huyt tng
nguyn thu
nguyn thu
O
O

A hoc O

B hoc O

AB

AB

AB hoc A hoc B hoc O

34

5. Chn la cc n v mu ton phn, khi hng cu, tiu cu, bch cu


ht theo nhm Rh(D) theo yu cu sau:
Nhm mu ngi bnh nhn mu

Nhm mu ca n v mu truyn

D(-)

D(-)

D(+)

D(+) hoc D(-)

iu 45. Bo m ha hp min dch trong mt s trng hp cp cu


1. Trong trng hp cp cu, khng kp lm y xt nghim theo quy
nh ti Khon 2 iu 42 v iu 43 Thng t ny hoc khng xc nh c
nhm mu ngi bnh hoc khng la chn c n v mu, ch phm mu ph
hp, nu c s ng bng vn bn ca bc s iu tr c th cp pht nh sau:
a) Truyn thay khi hng cu nhm O cho ngi bnh c ch nh truyn khi hng
cu theo quy nh ti Khon 1 iu 44 Thng t ny.
b) Truyn khi hng cu nhm O, Rh(D) m cho ngi bnh nhm mu
Rh(D) m hoc khng xc nh nhm Rh(D);
c) Truyn huyt tng nhm AB cho ngi bnh c ch nh truyn huyt tng
theo quy nh ti Khon 2 iu 44 Thng t ny.
2. Ch truyn mu nhm Rh(D) dng cho ngi nhn mang nhm Rh(D)
m trong trng hp e da n tnh mng ngi bnh v c cc iu kin sau:
a) Ngi bnh l nam gii.
b) Trong trng hp ngi bnh l ph n trong tui sinh : cn nhc
li ch iu tr hin ti v nguy c tai bin cho thai nhi nu ngi bnh mang thai
trong tng lai;
c) Xt nghim ha hp min dich s dng huyt thanh chng globulin nhit
37 C cho kt qu m tnh;
o

d) C s ng bng vn bn trong kt qu hi chn gia ngi ph trch


hoc ngi c y quyn ca n v pht mu, bc s iu tr v c s ng
ca ngi bnh hoc ngi nh ca ngi bnh.
iu 46. Lm tan ng, m ti mu, ch phm mu
1. Vic lm tan ng ti ch phm mu phai bao am cac iu kin sau:
a) Lm tan ng ch phm mu theo quy nh ti im c Khon 4 iu 18
Thng t ny;
35

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.
36

3. Thc hin nh nhm mu h ABO ca ngi bnh, ca tui mu ngay ti


ging bnh v i chiu vi thng tin trn phiu truyn mu
a) Khi truyn mu ton phn, khi hng cu, khi bch cu: s dng huyt
thanh mu nh nhm mu ABO ca mu mu ngi bnh c ly ngay trc khi
truyn mu v ca mu mu ly t n v mu sp truyn.
b) Khi truyn tiu cu, huyt tng:
- S dng huyt thanh mu nh nhm mu ABO mu mu ca ngi bnh;
- Trn 02 git ch phm mu vi 01 git mu ngi bnh v kim tra
ngng kt. Khng thc hin truyn mu khi c ngng kt, tr trng hp truyn
ta lnh theo quy nh ti Khon 3 iu 44 Thng t ny.
c) Phi hp vi n v pht mu ,iu tra lm r mi s khc bit (nu c)
gia h s bnh n, phiu truyn mu, nhn n v mu v kt qu nh nhm.
4. Thc hin vic truyn mu, theo di din bin, pht hin, x tr cc bt
thng v tnh trng sc khe ca ngi bnh:
a) Kim tra, theo doi cc ch s mch, nhit , huyt p, trng thi tinh
thn ca ngi bnh vo cc thi im trc va trong qua trinh truyn mau, c
bit lu y theo doi trong 15 pht u truyn mau pht hin v x tr kp thi tai
bin lin quan n truyn mau;
b) Phai s dng b dy truyn mu c bu lc truyn cho ngi bnh;
c) Ghi h s y cac chi s mch, nhit , huyt p, trng thi tinh thn,
din bin lm sang cua ngi bnh, cc x tr (nu c) vo phiu truyn mu theo
quy nh ti Ph lc 10 ban hnh km theo Thng t ny;
d) Cn c tnh trng cua ngi bnh v din bin trong qua trinh truyn
mu, bc s iu tr ch nh vic theo di sau khi kt thc truyn mu.
5. Khng c b sung bt c cht gi (bao gm ca cac loai thuc) vo tui
mu, tr trng hp c chi inh ho long khi hng cu thi chi c s dung dung
dch mui ng trng (NaCl 0,9%) loi truyn tnh mch.
6. Khi xy ra cc tai bin lin quan n truyn mu, c s iu tri phai thc
hin ngay cac vic sau:
a) Ty theo mc nghim trng cua tai bin ma phai gim tc hoc
ngng truyn mu. Trng hp ngng truyn mu, phi duy tr ng truyn tnh
mch bng cach s dung dung dich mui ng trng;
b) X tri cp cu ngi bnh;
37

c) Khng c tip tc truyn n v mu, ch phm mu c lin quan n


tai bin sau khi ngng truyn qu 4 gi.
iu 51. Vic tr, nhn li v s dng n v mu c tr li
1. Khi khng s dng n v mu cp pht, c s iu tr (khoa, phng)
phi tr li ngay cho c s pht mu.
2. C s pht mu ch s dng n v mu tr li truyn cho ngi
bnh khc khi c y nhng iu kin sau:
a) Cn hn s dng;
b) Khng pht hin c cc du hiu bt thng c quy nh ti Khon
2 iu 41 Thng t ny;
c) n v mu sau khi lnh, c bo qun, vn chuyn iu kin ng
quy nh v c xc nhn bng vn bn ca ngi ph trch khoa, phng iu tr.
iu 52. Xac inh nguyn nhn gy tai bin lin quan n truyn mu
1. Khi xut hin cc tai bin xy ra trong va sau truyn mu, xac inh
nguyn nhn, c s iu tri phai thc hin ngay mt s vic sau:
a) i chiu thng tin h s bnh n ca ngi bnh, nhn n v mu
truyn v phiu truyn mu. Kt qu i chiu phi ghi h s bnh n.
b) Thu thp li mu mu ngi bnh ly trc khi truyn mu, ng thi
ly mu mu, mu nc tiu ca ngi bnh. Trng hp tai bin nng e da n
tnh mng ngi bnh, phi tin hnh nh nhm mu h ABO ngay ti ging
bnh do nhn vin ca c s pht mu thuc c s khm bnh, cha bnh thc
hin. Kt qu nh nhm mu phi ghi bnh n vi xc nhn ca bc s iu tr,
lnh o c s iu tr v ngi thc hin k thut nh nhm mu;
c) Thng bo tai bin c lin quan n truyn mu cho c s pht mu v phng
k hoch tng hp theo quy nh ti Ph lc 11 ban hnh km theo Thng t ny;
d) Chuyn cc n v mu, ch phm mu c lin quan v c s pht mu
thc hin tip cc cng vic theo quy inh tai Khoan 2 iu nay;
) Phng k hoch tng hp lp bo co Hi ng truyn mu v c s a
cung cp n vi mau, ch phm mu o theo mu quy nh ti Ph lc 11 ban hnh
km theo Thng t ny.
2. C s pht mu phi kim tra, i chiu li h s lin quan, thc hin cc
xt nghim nhm xc nh nguyn nhn tai bin lin quan n truyn mu v tr li
kt qu xt nghim cho c s iu tr, phng k hoch tng hp theo mu quy nh
ti Ph lc 12 ban hnh km theo Thng t ny.
38

3. C s pht mu phi hp vi c s cung cp n v mu, ch phm


mu c lin quan xc nh nguyn nhn.

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

2. Cc xt nghim phi thc hin trc khi ly mu, gm:


a) nh nhm mu h ABO;
b) Xt nghim phat hin cc tc nhn ly truyn bnh qua ng mu, ti
thiu gm: HBsAg, khng th khng HIV-1 v HIV-2, khng th khng HCV,
giang mai.
3. Th tch mu ly mi ln khng qu 7 ml/kg cn nng; mi ln ly mu
cch nhau ti thiu 03 ngy v ln ly mu cui cng trc thi im phu thut t
nht 72 gi.
4. Bc s iu tr xem xt chi inh s dng cht kch thch to hng cu
Erythropoietin.
5. Vic iu ch, bo qun n v mu, ch phm mu 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. Thc hin xt nghim ho hp min dich trc khi truyn mu, thc hin
truyn mu v xc nh nguyn nhn gy tai bin lin quan n truyn mu t thn
phi thc hin theo cc quy nh ti cc iu 40, 41, 43, 46, 47, 48, 50, 51 v 52
Thng t ny.
iu 55. Truyn mau t thn pha long mu ng tch
1. Tiu chun la chon ngi bnh
a) Tui t 16 tui n 60 tui;
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 l 0,33;
) Phu thut c s dng k thut tin m hoc gy m ton thn;
e) Khng p dng ch nh truyn mu t thn pha long ng tch trong
trng hp ngi bnh c dung np km i vi tnh trng gim cung cp oxy.
2. Cc xt nghim phi thc hin trc khi ly mau: thc hin theo quy
inh tai Khoan 2 iu 54 Thng t nay.
3. Yu cu i vi vic thc hin pha long mu ng tch v truyn li cho
ngi bnh:
a) Th tch mu ly trc phu thut khng qu 7 ml/kg cn nng;
40

b) Hematocrit ca ngi bnh khng c thp hn 0,25 sau khi ly mu;


c) Phai duy tr cn bng th tch mu ly ra v th tich dch truyn vao c
th bng cc loi dung dch ng trng theo t l s lng dich truyn vao c th
gp 3 ln s lng mau c ly ra khoi c th hoc bng dung dch cao phn t
theo t l 1:1.
iu 56. Truyn mu hon hi
1. Ch thc hin truyn mu hon hi khi khng c mu lu tr cp
cu v khng c phng thc iu tri khc thay th truyn mau cho ngi bnh.
2. Mu hon hi c ly trong qu trnh phu thut hoc t ng dn lu.
V d: trong trng hp v lach, dn lu t trung tht sau phu thut m tim.
3. Mu thu c truyn hon hi phi c x l theo quy trnh ph hp
trnh nguy c nhim khun, tan mu va loi b c cc ng mu.
4. Mu hon hi phi c truyn trong vng 04 gi, k t thi im thu
nhn mu hon hi.
5. H s truyn mu hon hi phi c lu trong bnh n ca ngi bnh.
6. Khng thc hin truyn mu hon hi trong cc trng hp sau:
a) V tng rng;
b) Mau chay ra a qua 06 gi;
c) Mu c nguy c nhim khun;
d) C du hiu tan mu.

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
41

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

d) xut vic t chc o to, tp hun cc quy trnh chuyn mn v quy


nh v truyn mu;
) Gim st, phn tch, tng hp v bo co cc tai bin c lin quan n
truyn mu;
e) nh gi vic thc hin cc quy trnh, quy nh hot ng truyn mu
ph hp vi iu kin ca c s khm bnh, cha bnh;
g) Thc hin s kt, tng kt v bo co nh k 06 thng v 12 thng.
3. Hot ng:
a) Hi ng lm vic theo nguyn tc tp th, quyt nh theo a s v cc
vn lin quan n hot ng ca Hi ng. Trng hp c kin khc bit, s
phiu ca cc thnh vin hi ng bng nhau th Ch tch Hi ng l ngi quyt
nh cui cng. Y kin khac bit c bao lu va ghi vao bin ban lam vic cua hi
ng. Cc thnh vin ca Hi ng lm vic theo ch kim nhim;
b) Hi ng hp nh k mi qu mt ln. Trng hp hp t xut do
Ch tch hi ng quyt nh;
c) Bin bn hp Hi ng phi ghi y kin ca tng thnh vin
pht biu ti phin hp v phi c y ch k ca Chu tich va Th ky Hi ng.
d) Ch tch Hi ng quy inh hot ng c th v phn cng nhim vu cho
cc thnh vin Hi ng.

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.
44

b) Ti liu lin quan n hot ng xt nghim, iu ch, bo qun, cp


pht mu, ch phm mu, bao gm:
- M ca n v mu, ch phm mu;
- Loi, l, hn s dng, kim tra cht lng sinh phm xt nghim;
- Kt qu v kt lun xt nghim;
- Ti liu v bo qun, kim tra v tiu hu mu bnh phm lu;
- Ti liu lin quan n ch phm mu t mi lt hin mu;
- Thng tin v tn loi ch phm mu, phng thc iu ch, trang thit b,
dng c s dng, m hiu, nhm mu, ngy iu ch, ngy ht hn s dng, tn c
s ly mu, xt nghim v iu ch.
2. Lu gi h s ti c s khm bnh, cha bnh s dng mu:
a) Ti liu lin quan n vic nhn mu t cc c s bn ngoi:
- Phiu giao nhn mu, ch phm mu;
- Phiu tr mu, ch phm mu (nu c).
b) Ti liu lin quan vic nhn mu t cc khoa, phng trong ni b c s
khm bnh, cha bnh:
- Phiu d tr mu, ch phm mu;
- S cp pht mu, ch phm mu.
c) Ti liu lin quan n vic xt nghim pht mu bo m ha hp min
dch truyn mu:
- Loi, l, hn s dng, kim tra cht lng sinh phm xt nghim;
- Kt qu nh nhm mu v xt nghim ha hp min dich;
- Kt qu xt nghim sng lc v nh danh khng th bt thng (nu c).
d) Ti liu lin quan n s dng mu ti c s khm bnh, cha bnh: s
d tr, cp pht mu, ch phm mu v phiu truyn mu;
) Ti liu lin quan n vic x l khi c tai bin lin quan n truyn mu:
- Ti c s pht mu: bo co tai bin lin quan n truyn mu; bin bn
giao nhn n v mu, ch phm mu lin quan n tai bin; kt qu cc xt
nghim iu tra tai bin lin quan n truyn mu theo quy nh ti Khon 2 iu
52 Thng t ny;

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.

46

2. Ch o, t chc, hng dn, kim tra thc hin cc vn bn quy phm


php lut, chin lc, quy hoch, k hoch, cc quy nh chuyn mn, quy chun
k thut quc gia, qun l cht lng i vi cc c s truyn mu, cc c s khm
bnh, cha bnh s dng mu.
3. Ch tr hoc phi hp thm nh cc iu kin cho php ng dng cc k
thut mi, k thut cao trong hot ng truyn mu theo quy nh ca php lut.
4. T chc thm nh vic cp php, nh ch hot ng ca cc c s khm
bnh, cha bnh c hot ng truyn mu theo quy nh ca php lut.
5. Lm u mi t chc cc hi ng chuyn mn gii quyt cc vn v
chuyn mn, k thut, ch o, hng dn cc hot ng nghin cu khoa hc v
hp tc quc t trong lnh vc hot ng truyn mu.
6. Ch o, hng dn, bi dng nng cao nng lc qun l nh nc v
chuyn mn nghip v cho cn b qun l trong hot ng truyn mu.
7. Ch o, hng dn thc hin trin khai ng dng cng ngh thng tin,
thng k s liu, xy dng c s d liu trong qun l hot ng truyn mu.
iu 64. Trch nhim ca Vin Huyt hc - Truyn mu Trung ng
1. Lm u mi xut, tham mu, kin ngh vi B Y t trong vic 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;
2. Trin khai o to, hng dn, h tr chuyn mn, k thut lin quan n
hot ng truyn mu trong phm vi ton quc.
3. Trin khai cc nghin cu, nh gi v cht lng, phng cch s dng
cc loi thuc th, sinh phm, thit b, dng c s dng trong hot ng truyn mu
theo quy nh ca B Y t.
4. Trin khai ng dng cng ngh thng tin, thng k s liu, xy dng c
s d liu qun l hot ng truyn mu trong phm vi ton quc.
5. Thc hin trin khai hot ng gim st nguy c truyn mu trong phm
vi ton quc.
6. Kim tra v nh gi hot ng cc c s truyn mu trong phm vi ton
quc theo biu mu quy nh ti Ph lc 15 ban hnh km theo Thng t ny.
47

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
48

lc cc tc nhn ly truyn bnh qua ng mu v nh nhm n v mu; iu


ch, bo qun, vn chuyn mu v ch phm.
6. Thc hin cc th tc trnh cp c thm quyn tn vinh, khen thng
v bo m cc quyn li khc ca ngi hin mu theo quy nh ca php lut.
7. T chc thc hin qun l, gim st nguy c trong truyn mu c quy
nh ti iu 57, iu 58 Thng t ny.
8. Phi hp vi cc c s khm bnh, cha bnh s dng mu trong vic:
a) Cung cp, vn chuyn, bo qun mu, ch phm mu an ton, ph hp
theo nhu cu v s lng, chng loi ca c s s dng mu;
b) Cung cp cc thng tin v cc n v mu, ch phm mu c lin quan
n cc tai bin xy ra ngi bnh nhn mu;
c) Tm hiu, iu tra nguyn nhn cc tai bin lin quan n truyn mu;
d) Xy dng ti liu, thc hin o to tp hun v s dng mu hp l
trong iu tr lm sng.
9. nh k hoc t xut kim tra, theo di v nh gi hot ng truyn
mu trong phm vi khu vc c giao qun l theo biu mu quy nh trong Ph
lc 15 ban hnh km theo Thng t ny.
10. Tng hp, phn tch, bo co kt qu thc hin hot ng truyn mu
ca cc c s khm bnh, cha bnh trong khu vc c giao ph trch v Cc
Qun l khm, cha bnh - B Y t v Vin Huyt hc - Truyn mu Trung ng.
11. 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.
iu 67. Trch nhim ca c s khm bnh, cha bnh c s dng mu
1. Gim c c s khm bnh, cha bnh c s dng mu c trch nhim bo
m hot ng truyn mu an ton, hiu qu ti n v do mnh ph trch, bao gm:
a) T chc thnh lp Hi ng truyn mu theo quy nh ti Chng VIII
v hot ng xet nghim, cp pht, s dng; qun l cc tai bin lin quan n
truyn mu c quy nh ti iu 50, iu 52 Thng t ny; t chc n v pht
mu ti c s khm bnh, cha bnh hoc c hp ng h tr chuyn mn vi c
s khc c kh nng thc hin xet nghim ho hp min dch truyn mu;
b) Ch o, t chc xy dng v ph duyt cc quy nh, quy trnh, hng
dn chuyn mn truyn mu lm sng ca c s khm bnh, cha bnh; t chc
49

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

d) Thc hin cc quy nh c lin quan n trch nhim ca khoa, phng


iu tr c truyn mu c quy nh ti Thng t ny.
iu 68. Trch nhim ca ngi ng k hin mu
1. Tr li trung thc v tnh trng sc kho v chu trch nhim v ni dung
tr li ca mnh.
2. K xc nhn hiu r cc thng tin v t nguyn hin mu, sau khi c
gii thch v in vo bng hi tnh trng sc khe ngi hin mu theo quy nh ti
Khon 2 iu 7 Thng t ny v Ph lc 2 ban hnh km theo Thng t ny.
3. Khng li dng vic hin mu khm sc khe, xt nghim min ph.
4. T gic khng hin mu nu xt thy bn thn khng iu kin hin
mu theo quy nh ti iu 4, iu 5, iu 6 Thng t ny. Khng che giu cc
nguy c mc bnh ca bn thn khi ng k, tham gia hin mu.
5. Sau khi hin mu, cn bo ngay cho c s tip nhn mu nu t pht hin
thy bn thn c nguy c mc bnh vim gan, nhim HIV v cc bnh ly truyn khc.
iu 69. Trch nhim ca ngi bnh c truyn mu
Cung cp cc thng tin chnh xc v tnh trng sc kho ca c nhn h tr
nhn vin y t trong vic ch nh, theo di v x tr cc tai bin (nu c).

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;

51

b) Cc c s truyn mu trn a bn cc tnh, thnh ph Thi Nguyn, Hi


Phng, Thanh Ho, Ngh An, Nng, Khnh Ho, c Lc, Bnh nh phi thc
hin trc ngy 01 thng 01 nm 2017;
c) Cc c s truyn mu cn li trn ton quc phi thc hin trc ngy 01
thng 01 nm 2018.

52

iu 71. Hiu lc thi hnh


Thng t ny c hiu lc thi hnh k t ngy 15 thng 11 nm 2013.
Bi b Quyt nh s 06/2007/Q-BYT ngy 19 thng 01 nm 2007 ca B
trng B Y t v vic ban hnh Quy ch Truyn mu k t ngy Thng t ny c
hiu lc thi hnh.
Trong qu trnh thc hin, nu c kh khn vng mc, cc n v, a
phng bo co v Cc Qun l Khm, cha bnh, B Y t nghin cu, xem xt
v gii quyt./.
Ni nhn:
- Vn phng Chnh ph (Cng bo; Cng TTTCP);
- B T php (Cc Kim tra VBQPPL);
- B trng B Y t Nguyn Th Kim Tin ( b/c);
- Cc V, Cc, Tng cc, VP, Thanh tra B Y t;
- S Y t cc tnh, thnh ph trc thuc TW;
- Cc BV, vin c ging bnh trc thuc B Y t;
- Y t cc B, ngnh;
- Cng TTT B Y t (moh.gov.vn);
- Trang tin T Cc QL KCB (kcb.vn);
- Lu: VT, PC, KCB.

KT. B TRNG
TH TRNG

Nguyn Th Xuyn

53

You might also like