Cn lm g t tiu chun phng xt nghim an ton sinh hc

Cp nht lc 13:39 05/04/2014

Tp ch Y hc d phng s 1/2014 xin gii thiu cng Qu c gi bi vit v
An ton sinh hc phng xt nghim ca Tca TS. Nguyn Thanh Thy,
Trng khoa An ton sinh hc v Qun l cht lng, Vin V sinh dch t
trung ng v nhng tiu chun thit yu t c tiu chun phng xt
nghim an ton sinh hc
An ton sinh hc (ATSH) phng xt nghim (PXN) l vic thc hin cc bin
php nhm gim thiu hoc loi tr cc tc ng c hi c th pht sinh t phng
xt nghim hoc qu trnh vn chuyn tc nhn gy bnh n ngi lm xt
nghim, cng ng v mi trng. Theo s liu hin c, nhiu tai nn, s c xy
ra ti cc phng xt nghim c s dng tc nhn vi sinh vt gy bnh cho ngi.
c bit, nhiu trng hp b ly bnh dn n t vong cng xy ra [8].
bo m an ton sinh hc, T chc Y t Th gii a ra cc hng dn
v quy nh v ATSH cho cc PXN t nhiu nm nay. Nhiu nc, c bit l cc
nc pht trin, vic m bo an ton sinh hc ti cc PXN c thc hin mt
cch nghim ngt. T nhng nm 1940, cc nghin cu v cc trng hp mc
bnh truyn nhim lin quan n vic khng m bo an ton sinh hc trong PXN
c thc hin [2].
Ti Vit Nam n nay thi hnh Lut Phng, chng cc bnh truyn nhim
(ban hnh ngy 21 thng 11 nm 2007) v Ngh nh Quy nh chi tit thi hnh
Lut Phng, chng bnh truyn nhim v m bo an ton sinh hc ti phng xt
nghim ca Chnh ph (ngy 30 thng 8 nm 2010) B Y t ban hnh 4 Thng
t lin quan trc tip n an ton sinh hc ti phng xt nghim bao gm: Thng
t Quy nh ch qun l mu bnh phm bnh truyn nhim (s 43/2011/TTBYT ngy 05 thng 12 nm 2011), Thng t Danh mc vi sinh vt gy bnh truyn
nhim theo nhm nguy c v cp an ton sinh hc ph hp k thut xt
nghim (s 07/2012/TT-BYT ngy 14 thng 5 nm 2012), Thng t Ban hnh quy
chun k thut quc gia v thc hnh v an ton sinh hc ti phng xt nghim (s
25/2012/TT-BYT ngy 29 thng 11 nm 2012), Thng t Quy nh th tc cp
mi, cp li giy chng nhn phng xt nghim t tiu chun an ton sinh
hc (s 29/2012/TT-BYT ngy 4 thng 12 nm 2012) [1,4,5,6,7].
Theo Thng t s 29/2012/TT-BYT, n trc ngy 1/1/2015, tt c cc PXN
phi c giy chng nhn an ton sinh hc ph hp c php hot ng.
c cp giy chng nhn, cc PXN phi p ng y cc yu cu v c s vt
cht, trang thit b, nhn s, thc hnh, phng nga, x l v khc phc s c
ATSH [7]. Vic p ng cc yu cu ny phi c th hin trong b h s ngh
cp giy chng nhn an ton sinh hc. n nay, trn c nc, c 2 PXN c

cp giy chng nhn ATSH cp III v khong 20 PXN c cp giy chng

nhn ATSH cp II. Nhiu PXN (ch yu ca cc trung tm YTDP tuyn tnh) ang
trong qu trnh chun b cho mc ch c xt cp giy chng nhn. gip
PXN cc tuyn nm chc hn trong qu trnh chun b h s xt duyt, sau y xin
im li nhng yu cu quan trng nht cho mt PXN t tiu chun ATSH. C th
xem ni dung chi tit theo a chhttp://www.nihe.org.vn/uploads/1-Yeu cau chuan
bi ho so tham dinh PTN ATSH cap II
H s ngh cp giy chng nhn
H s gi c quan cp giy chng nhn cn c cc loi giy t theo yu cu
ca thng t s 29/2012/TT-BYT. B H s lu ti PXN phi b sung thm cc
vn bn, ti liu chng minh c vic PXN p ng c cc yu cu cn
thit. Khi ngh cp giy chng nhn ATSH cho hai PXN tr ln, b h s phi
bao gm cc phn hoc file ring, bao gm: h s chung ca c quan, h s ring
ca tng PXN. Cc bn sao cn phi c chng thc (xc nhn sao y bn chnh
ca c quan c thm quyn nh c quan pht hnh bn chnh, y ban nhn dn x,
phng hay phng cng chng). Bng k khai trang thit b, h s nhn s phi th
hin c cc loi thit b c ti mi PXN, ai c phn cng lm vic ti PXN
ny (c quyt nh ca lnh o c quan). Ch khng a vo h s xt duyt
danh sch thit b, nhn s ca c khoa xt nghim hin c.
C s vt cht
Ti hu ht trung tm Y t d phng cc ch tiu v din tch, trn, sn, ca s,
ca ra vo p ng tiu chun. Tuy nhin, i vi yu cu v trang thit b cc
PXN cn lu cc im sau:
- Thit b ra mt khn cp:
Mt s c s lp t thit b ra mt ni vi h thng cung cp nc sch ti
hnh lang, s dng chung cho mt s PXN. Cc thit b ny nn c kim tra, v
sinh t nht mt thng mt ln trnh vic thit b b tc, bn. p ng yu cu
ny, c th t mt chai nc ra mt loi 1 lt ti mi PXN.
- Bn ra tay:
Nhiu PXN c treo mt khn lau tay pha trn bn ra tay. Vic dng mt khn
ny cho nhiu ngi c th lm pht tn tc nhn gy bnh. Tt nht, chng ta nn
c hp giy lau tay s dng mt ln hoc hp cha nhiu khn nh, mi khn dng

mt ln v sau git sch dng li.

- Hp s cu:
Nn c cc vt liu, dng c ti thiu x l cc trng hp b kim m,
vt thng nh (bng, bng gc, bng dnh, panh, ko). Cng nn lu n hn
s dng ca cc vt liu s cu ny.

- Van chng tro ngc

Dng cho ng ng cp nc sch (c th khng cn thit i vi nhng c
s cp nc cho PXN t b cha t trn cao v nc t vi nc trong PXN
khng th tro ngc trong trng hp ny). chng minh PXN c nc sch
nn c hp ng gia cng ty cp nc sch v c s c PXN.
- H thng x l nc thi
Do hin ti cha c tiu chun quc gia v h thng x l nc thi nn c s
c PXN phi c h thng ng dn, b thu gom nc thi v c th ly c nc
thi b ny kim tra. Nc thi t PXN p ng c cc tiu chun quc gia
v nc thi y t (QCVN 28:2010/BTNMT) trc khi ra h thng nc thi
chung.
- n cc tm:
Ty theo mc ch s dng ca PXN, cng ca n cc tm cn c tnh
ton v kim tra bi ngi c o to, bng thit b tin cy m bo
hiu qu kh trng. Cng tc bt, tt n tm khng t trong phng c n tm
trnh vic ngi s dng b n cc tm gy hi.
Yu cu v h thng in l rt quan trng trong bo m an ton v chnh
xc ca thit b. Cc PXN khng c b qua hoc coi nh yu cu tip a.

p ng yu cu ny, ton b h thng in ca PXN cn c tip a ng k

thut th hin qua bn thit k, kt qu o v nhn thy c cm 3 l, hoc c
im tip a. cc thit b c tip a thc s cn c phch cm v dy ni
ph hp n thit b (3 dy). Nhng yu cu khc v h thng cung cp in cho
PXN cng cn c tn trng.
Trang thit b chuyn dng
Theo quy nh, PXN an ton sinh hc cp II phi c t ATSH cp II, tuy nhin,
v tc dng bo v ngi lm xt nghim v mi trng th t ATSH cp I v cp
III cng c tc dng tng t hoc thm ch an ton hn. t nht 2 thit b chuyn
dng l t ATSH v ni hp tit trng phi c kim tra bi c quan c thm
quyn v c nng lc t nht mt nm mt ln. Ti, thng ng cht thi ngoi
vic p ng cc tiu chun v hnh thc (ng mu, thng ng cht thi c np
y m bng chn) th cht liu, dy ca ti (nha PP, dy t nht 0,1 mm) phi
tun th theo quy ch x l cht thi y t ban hnh km theo Quyt nh s
43/2007/Q-BYT.
Nhn s phng xt nghim
C s c PXN phi phn cng ngi ph trch v an ton sinh hc. Vic phn
cng ny phi c th hin bng vn bn. Cc quy nh khng yu cu phi o
to li v ATSH hng nm m ch yu cu cc nhn vin PXN c o to li
theo quy nh v o to lin tc ca B Y t. Cn c bng chng v vic nhn
vin PXN c o to v o to li.
Thc hnh
nh gi nguy c l mt khi nim kh mi i vi cc PXN, tuy nhin li l
mt yu cu bt buc cho vic cp php. Cc hc vin tham gia kha o to
v ATSH do Vin V sinh dch t Trung ng t chc trong nm qua c cung
cp cc kin thc, thc hnh c bn v biu mu tin hnh cng vic ny. Kt
qu nh gi nguy c cn c s dng a ra cc bin php an ton ph hp.
Bin bn nh gi nguy c phi c lu trong h s ca thnh PXN.
Cc quy trnh thc hnh s dng c s vt cht v thit b chuyn dng cn ph
hp, c ch k ca ngi c thm quyn v t nhng v tr d tip cn, quan st.
Vic sao chp n thun t hng dn ca nh sn xut nhiu khi l cha .
c quy trnh ph hp, cn tham kho cc bc xy dng quy trnh theo yu cu ca
qun l cht lng (v d ISO 15189, ISO 17025) v yu cu mt ngi thc hin
th quy trnh ny trc khi chnh thc ban hnh. Cn lu m bo tun th quy

trnh v phn loi, x l cht thi. Quy trnh tit trng cht thi bng ni hp phi
bao gm c vic kim tra kt qu tit trng bng cc loi ch th sinh hc hoc ha
hc.
Phng nga, x l v khc phc s c
Do cc quy nh khng nu c cc loi s c m PXN phi c k hoch, quy
trnh phng nga, x l nn trc mt PXN nn chun b i ph vi cc s c
c cho l d xy ra trong cng vic thng quy nh nh vt liu ly nhim,
b thng do vt sc nhn (kim m)Vic chun b, x l cc s c ny cng
c hng dn trong cc kha o to v an ton sinh hc ti PXN cng nh
trong cc ti liu hng dn thng quy phng th nghim.
B o m ATSH cho cc PXN vi sinh trong h thng trung tm YTDP l yu
cu khng th thiu i vi mc tiu xy dng chun v YTDP hin nay. Vi cc
ni dung lu nh trn, hi vng cc PXN c th rt ngn phn no thi gian
chun b h s cng nh cc iu kin cn thit khc c cp giy chng nhn
an ton sinh hc. Cc thng tin thm v an ton sinh hc c th tham kho ti
website ca Vin V sinh dch t Trung ng (http://www.nihe.org.vn). Mu v
hng dn thc hin Bng kim PXN c mc ATSH cp II c th xem ti
http://www.nihe.org.vn/uploads/2 Bang kiem ATSH PXN ATSH II_co giai
thich_17092013.doc.
TI LIU THAM KHO
1. Lut Phng chng cc bnh truyn nhim. NXB Chnh tr Quc gia, H Ni,
2007, tr.27.
2. Laboratory Biosafety Manual. WHO. Third Edition: pp.1, 2, 49, 2004.
3. Chnh ph (2010), Ngh nh s 92/2010/N-CP Quy nh chi tit thi hnh
Phng, chng bnh truyn nhim v m bo an ton sinh hc ti phng xt
nghim.
4. B Y t (2011), Thng t s 43/2011/TT-BYT quy nh ch qun l mu
bnh phm bnh truyn nhim
5. B Y t (2012), Thng t s 07/2012/TT-BYT quy nh Danh mc vi sinh
vt gy bnh truyn nhim, theo nhm nguy c v cp an ton sinh hc
ph hp k thut xt nghim

6. B Y t (2012), Thng t s 25/2012/TT-BYT ban hnh Quy chun k thut

quc gia v thc hnh v an ton sinh hc ti PXN
7. B Y t (2012), Thng t s 29/2012/TT-BYT quy nh th tc cp mi, cp
li giy chng nhn PXN t tiu chun an ton sinh hc.
8. An ton sinh hc ti phng xt nghim an ton sinh hc cp II. NXB Y hc,
2014.
Nguyn Thanh Thy, Mai Th Hin
Vin V sinh Dch t Trung ng