Cn lm g t tiu chun phng xt nghim an ton sinh hcCp nht lc 13:39
05/04/2014Tp 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 nhQuy nh chi tit thi hnh Lut
Phng, chng bnh truyn nhim v m bo anton sinh hc ti phng xt nghimca
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 tQuy nh ch qun l
mu bnh phm bnh truyn nhim(s 43/2011/TT-BYT ngy 05 thng 12 nm 2011),
Thng tDanh 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 tBan 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 dISO 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.Bo 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 KHO1. 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 nhim5. 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 nghim6. 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 PXN7. 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 HinVin V sinh Dch t Trung ng
