----------------------- ---------

BQ Y T:E CONG HOA xl HOI CHU NGHiA VIET NAM. . .DQc I~p - Tl! do - H~nh phuc

Ha N9i, ngay;SthcingA2nam 2015s6:5530 IQD - BYT

4Z~~'~ c#A(~.

~ Can cir Luat Kham benh, chua benh 86 40/2009/QH12, namlL...,btJ.Y¥··:-·)L!-. '-~-'-' '-'-' .; -' .; .: '-'

~ ~ Can cir Nghi dinh s6 63/20 12IND-CP, ngay 31/8/2012 cua Chinh phu quydinh chirc nang, nhiem \TV, quyen han va co c~u t6 chirc cua BQY tS;

Xet dS nghi cua HQi d6ng chuyen mon nghiem thu Hu6ng dfuI xay dungquy trinh thirc hanh chuan trong quan ly ch~t IUQIlgxet nghiem;

QUYETDINHBan hanh Hmrng d~n xay dung quy trinh tlnrc hanh ('..h-1CUIl.jCiHy~T...,.,E·-G-IA-O-TH-=-6-N-G """'V;":-N-TA

trong quan.ly ch~t Iuong xet nghi~m .CONG VAN DEN

BO TRU'ONG BO Y TE04 -01- 2016

Theo dS nghi cua Cue tnrong Cue quan ly kham, chua benh,

QUYETDINH:

Di~u 1. Ban hanh kern thee Quyet dinh nay "Huang dfuI xay dung quytrinh thirc hanh chu§n trong quan ly ch~t hrong xet nghiem" tai cac ca sa khamb~nh, chua b~nh.

Di~u 2. Huang dfuI xay dvng quy trinh thvc hanh chu~n trong quan lych~t lugng xet nghi~m dugc ap dVng tC;licac ca sa kham b~nh, chua b~nh dStimg buac chuk hoa ch~t IUQIlgxet nghi~m.

Di~u 3. QuYStdinh nay co hi~u l\Ic kS illngay ky ban hanh.

Di~u 4. Cac ong, ba: Chanh Van phong BQ, Cvc truang Cvc Quan 1ykham, chua b~nh, Giam d6c cac b~nh vi~n tf\l'CthuQc BQY tS, Giam d6c Sa Y tScac tinh, th8nh ph6 tI1JCthuQc Trung uang, Y t@cac BQ, nganh, Giam d6c cactrung tam kiSm chuk ch~t lugng xet nghi~m va Thu twang cac dan vi co lienquan chiu tnich nhi~m thi hanh QuySt dinh nay.!.

NO'inhan:- Nhu di€u 4;- B9 truong (d~hie);- Luu: vr,KCB.

BO GIAO THONG vAN TAlCVCYTE

S6;)rS /SY-CYT

Nai nhtin:- Cac Benh vien, Phong kham da khoa, Trungtam y tS GTVT, Trung tam f)i~u dirongPHCN - BNN GTVT (qua Website Cue Y tS);- Cue tnrong, cac Pho Cue tnrong (d€ b/e);- Liru: VT, NVYD.

SAO Y BAN CHiNH

Ha N9i, ngay Of thang 01 ndm 2016

------ --_ .._--- -----

)_ .c.

BOYTE.

HuONGDANXAYmrxc QUY TRINH THl/C HANH CHuAN

TRONG QUAN LY CHAT LUQNG XET NGHI:¢MT~I CO SOKHAM B:¢NH,CHi)A B:¢NH

(Ban hiinh kem thea Quyit a/nit sa 5530IQD-BYT ngay 25 thdng 12 niim 2015cua Bp truting Bp Yd)

HA NOI, THANG 12 NAM 2015

LOINOlflA.U

Trong nhirng nam g~n day cong tac quan ly chAt hrong xet nghiem dffdiroc BQY tS d~c bi~t quan tam, chi dao nham nang cao nang hrc h~ thong xetnghiem, bao dam kSt qua xet nghiem chinh xac, kip thai, tranh lang phi, tiStkiem cho nguoi benh,Nam 2013 BQY ts dffban hanh Thong tu s6 0112013/TT­BYT vS "Huang dfuI thuc hien quan ly chAt hrong xet nghiem tai co sa khambenh, chua benh", trong do quy dinh cac dan vi phai xay dung quy trinh thirchanh chuan, day la mQt trong nhtrng nhiem V1,l quan trong trong quan 1y chAthrong xet nghiem d~ bao dam cong viec diroc tlnrc hien mot each nhat quan vakSt qua xet nghiem duoc chuan hoa va chinh xac,

Hien nay, nhiSu dan vi dff va dang n6 lire trien khai Thong tu neu tren,chAt luQ'llgxet nghi~m khong ngimg duqc nang cao va ki~m soli! t6t han. Tuynhien, thvc tS vfuI con co phong xet nghi~m t~i cac co sa y tS dli dff co cac quytrinh thvc hanh chuk nhung chua d~y du, d6ng bQva hi~u qua chua cao; con cophong xet nghi~m thiSu ho~c th~ chi la chua co cac quy trinh thvc hanh chuktrong quan ly chAt luQ'llgtheo quy dinh. NhUng bAtc~p neu tren do nhiSu nguyennhan, mQt trong nhUng nguyen nhan la con co cac can bQ,nhan vien quan ly vanguai lam xet nghi~m chua nfun ro vai tra va t~m quan tr<;mgcua vi~c tuan thu(th\lc hi~n) theo quy trinh th\lc hanh chuftn quan 1ychAt luqng xet nghi~m.

Do do, truac yeu c~u d~t ra 1a c~n chuftn hoa va huang dftn mQt cach d~ydu, chi tiSt va co h~ th6ng trong vi~c xay d\l'llg, bien so~ quy trinh th\lc hanhchuftn trong quan ly chAt luqng xet nghi~m, h6 trq cac phong xet nghi~m danhgia, kiSm tra kSt qua cac xet nghi~m va giam sat mQt cach khach quan, bao damkSt qua xet nghi~m dang tin c~y, vi~c ban hanh huang dftn viSt quy trinh th\lchanh chuftn trong quan 1ychAtluqng xet nghi~m la rAtck thiSt.

NQi dung cua Huang dfuIbao g6m: 03 chuang va cac ph\l h:lcI, II neu tenva cac vi d\l mftu vS quy trinh thvc hanh chuk trong quan ly chit luQ'llg xetnghi~m.

Day Ia lk d~u tien co mQt huang dfuI d~y du vS vi~c xay d\l'llg quy trinhthvc hanh chuftn trong quan ly chAt luQ'llgxet nghi~m, do v~y khong th~ tranhduqc thiSu sot, BQY tS (C\lCQuan ly kham, chua b~nh) rAtmong cac dan vi, canhan va cae ehuyen gia ti~p tl)C g6p Y dS Tai li~u Hu6ng d§n nay ngay canghoan thi~n va d~t chAt 1uqng t6t han, gop phk mang l~i lqi ich cao nhit chongum b~nh.

TM. BAN S04N THAO

LuO'ng NgQc Khue2

-------------- - --

Chli bienPGS.TS. Nguyen Thi Xuyen

DAng Chu bienPGS. TS. Luang Ngoc Khue

Ban bien soan

Ths. NguySn Trong Khoa

Ths. Bao Nguyen Minh

TS. Bui Thu HiSn

Ths. B6 Thi Thu Thuy

TS. Duong Ngoc CUOng

Ths. Le Sinh Quan

PGS.TS. B~g Thi NgQc Dung

Ths. Truong Quan Thuy

TS. Nguyen H6ng Hanh

Ts. Vii Van Truong

3

HQi dAng chuyen mdn th§m djnh

1. GS. DBDinh H6, nguyen Chu tich HQiH6a sinh Vi~t Nam.

2. Ths. NguySn Trong Khoa, Ph6 Cue tnrong Cue Quan 1;'Kham, chua benh, BQY tS

3. GS.TS. T~ Thanh Van, Ph6 Hi~u tnrong Truong D~i hoc YHa NQi, Giam d6c Trung tam kiem chuck chfit hrong xetnghiem thuoc D~i hoc Y Ha NQi

4. Ths. Pham Tufin Duong Ph6 Vi~n tnrong Vien Huyet hoc -Truyen mau trung irong

5. TS. Tr~n Hiru Tam, Giam d6c Trung tam kiem chuck xetnghiem TP.HCM

6. TS. Le Thi AM Hong, Truong khoa vi sinh, Benh vienXanhPon

7. TS. Nguyen Van Hung, Truong khoa Vi sinh va Labo Laochuan qu6c gia, B~nh vien Ph6i trung uong

8. Ths. Dao Nguyen Minh, Ph6 tnrong phong quan ly chfithrong, Cue Quan ly Kham, chua benh, BQY tS

9. Ths. Le Sinh Quan, Cvc Quan ly Kham, chua b~nh

4

Chu tich Hoid6ng

Ph6 Chu tichHQi d6ng.

Ph6 Chu tichHQi d6ng.

Uy vien,

Uyvien,

Uy vien

Uy vien.

Thir ky.

ThukY.

----------- - . - - .. - - - -

DANHMVCTUVIETTAT

Quy trinh thuc hanh chuan

T6 chirc Y tS ThS gioi

Kythu~t

Quan lyQuy trinh

Vi sinh

QTC Standard Operating Procedure

WHO World Health Organization

KT

Hoa sinh

QL

QTVS

. HS

5

MVCLVC

Chuong 1 7

QUYDlNH CI-flJNG 7

I. Muc dich 7

II. D6i nrong ap dung 7III. Giai thich til ngfr 7

IV. Nguyen cic thirc hien 7

Chirong II 8

cAc mroc xAY Dl)NG QUY TRiNH TmJC HANHCHUm 8

1. Lap kS hoach xay dung 8

2. Reisoat va chinh sua 8

3. Phe duyet va ban hanh 8

4. ·T~phuan va sir dung 9

5. Sua d&i b& sung va hru trii 9Chirong III 9

WdNG DAN BIEN SOANQUY TRiNH Tm;C HANHCHUAN 9

1.Yeu c~u vS th.S thirc trinh bay 9

II. Yeu c~u vS nQidung t6i thieu cua quy trinh thirc hanh chuan 12

TAl L$U TRAM KI-IAO 17

cAc Pill) Ll)C.

6

~-

Chuang IQUY I>JNH CHUNG

I. M\lc dich

Huang ddn bien SO~ quy trinh thirc hanh chuan trong quan ly ch~t hrong

xet nghiem (sau day viSt t~t la QTC), bao g6m quy trinh thirc hanh chuan vS quan

ly va quy trinh thuc hanh chuan vS kY thuat trong quan ly ch~t hrong xet nghiem.

II. 1>8i tU'Q'l1gap dung

1. Lanh dao cac co sa kham benh, chua benh;

2. Nhan vien phong xet nghiem;

3. Cac ca nhan, dan vi co lien quan trong quan ly ch~t hrong xet nghiem

III. Ghii thich tir ngfr

Quy trinh thirc hanh chuan (hay quy trinh thao tac chuan) trong quan ly

ch~t hrong xet nghiem la van ban huong ddn elf thS, chi r6 each tiSn hanh mot

cong viec elf thS trong cong tac quan ly va chuyen mon ky thuat nham bao dam

cac heat dQng diSn ra mQt each th6ng nh~t thea dung quy dinh.

IV. Nguyen t~c thl}'c hi~n

1. Phai xay dvng quy trinh thVChanh chu§n eho t~t ca cae eong vi~e vS

quan 1yva ehuyen mon kY thu~t eua phong xet nghi~m.

2. NQi dung trong quy trinh thvc hanh ehu~n phai dugc bien sOi;lnr6 rang,

sue tieh, d~y du, dS hiSu va tuan thu dung cae tai li~u huang ddn.

3. Quy trinh thvc hanh ehu~n phai duqc Lanh di;lOdan vi ho~c nguai co

thk qUYSnphe duy~t va ban hanh eho tUng quy trinh rieng Ie.

4. Quy trinh thvc hclnh ehu~ phai duge xem xet, ra soat dinh kY h~ng

nam. NSu co thay d6i, phai c~p nh~t va phe duy~t 1i;li.NSu khong thay d6i

khong phai phe duy~t li;linhung phai luu h6 sa vi~e xem xet.

5. NQi dung va thS thuc trinh bay quy trinh th\lC hclnh chu§n cua mBi co saco thS dugc diSu chinh eho phli hgp nhung phai bao dam cac yeu c~u cua Huang

ddn nay.

7

Chuong IICACBUaCxAYDVNGQUYT~THVcHANHCHUAN

1.L~ p k~ hoach xiy d 1}'ng

- Lap danh rnuc QTC dira vao cac dill ctr chinh nhu sau:

+Danh muc kY thuat da:diroc phe duyet cua dan vi;

+Cac cong viec lien quan dSn quan ly ch~t hrong; •

+Phan loai uu tien cac cong viec thuc hien tai phong xet nghiem.

- Phan cong ngtroi (hoac nhom) bien soan va phan cong nguoi (hoac

nhom) ra soat (xem xet) .

- Thuc hien bien soan thea hu6ng dfu1tai chuang III.

2. Ra soat va chinh sua

- Ngiroi duoc phan cong chiu trach nhiem thirc hien viec ra soat va chinh

sua.

- Qua trinh ra scat va chinh sua bao g6m cac buoc sau:

+ Giri du thao cho nguoi ra scat;

+Th6ng nhat vS cac gop y chinh sua;

+ Chinh sua du thao (nSu c~n);

+ Gui l~i dV thao da: chinh sua cho nhom bien so~ va dS nghi phan h6i

vao thai h~ nh~t d!nh;

+ T6ng hgp cac y kiSn dong gop dS hoan thi~n QTC (niu can, sJp xip

cUQch9P ili thing nhdt n<5idung);

+ KiSm tra dinh d~g quy trinh va n9i dung bkg bang kiSm truac khi

trinh lanh d~o phe duy~t;

+Nguai so~ thao, nguai ra soat Icy ten va ghi ngay thang tuang Ung

LU'll y: Qua trinh chlnh sua nay co thS thvc hi~n nhiSu l~ cho dSn khi

th6ng nh~t duQ'cquy trinh ca vS n9i dung va hinh thuc (ban dv thao cu6i clIng).

3. Phe dlly~t va ban hanh

- Lanh d~o dan vi ho~c ngum co thfun qUYSnphe duy~t cac QTC

- Cong b6 QTC da:duQ'cphe duy~t.8

- Phan phBi ban sao QTC dSn t~t ca cac nhan vien va khoa phong lien

quan.

4. Tip huin va su dung

- T?p hu~ su dung QTC cho t~t ca cac nhan vien lien quan trong vong 7-

10 ngay sau khi QTC dircc ban hanh va luu h6 sa ca nhan dii tham gia t~p huan

- Bao dam tuan thu dung QTC dii duoc ban hanh, xay dung h6 sa ghi cac

hanh dQng khac phuc,

5. Sua dBi b8 sung va hru trfr

- cAn sua d6i hoac b6 sung nQi dung khi co cac diSu chinh vS quy dinh

hoac chinh sach cua dan vi hoac khi QTC khong con phil hop.

- Liru ban gBc QTC theo quy dinh.

- Thu h6i d.t ca phien ban QTC cii da diroc ban hanh khi ban hanh quy .

trinh thay thS va hru trfr theo quy dinh,

Chuong IIIHUONG DAN BIEN SO~ QUY TRiNH THVC HANH CHUA.N

I. Yeu ciu v~ th~ tlnrc trinh bay

1. Trinh bay t6ng quat:

T~t ca cac QTC diroc trinh bay thea thS thuc nhu sau:

- Kh6 gi~y: Cac QTC duQ'c trinh bay tren gi~y kh6 A4 (210 mm x 297

mm).

- KiSu trinh bay: thea chiSu dai (Portrait) cua trang gi~y kh6 A4. TruOng

hgp QTC co cac bang, biSu, van ban co thS duQ'c trinh bay thea chiSu rQng

(Landscape) cua trang gi~y.

- Phong chfr: Times New Roman

- Bang rna: Unicode

- Co chfr: 13-14

- LS tren: cach mep tren 2cm

- LS du6i: cach mep du6i 2cm9

- LS phai: each mep phai 2cm

- LS trai: cac mep trai 3cm

- Khoang each giira cac dong: 1,5 dong

2. Trinh bay C\1 thS:

2.1. Trang d~u tien cua QTC bao g6m cac thong tin sau:

2.1.1. Ten co quan va ten khoa (phong), bieu tnmg (logo nSu co)

2.1.2. Ten quy trinh chu§n

2.1.3. Ma tai lieu: M6i QTC c~n diroc danh ma s6 rieng va duy nh~t c6

thS ky hieu thea chii viSt cit cua timg khoa (phong) hay thea phan loai QTC

(quy trinh quan Iy va quy trinh Icy thuat), vi du:

Quy trinh nuoi c~y vi khu§n cua khoa vi sinh diroc leY hieu nhu sau:

QTKT-VSNC - 01, trong do:

+QT chif viet t~t cua tir quy trinh;

+KT chtr viet t~t cua tir Icy thuat;

+VS chir viSt t~t cua khoa Vi sinh;

+NC chtr viet t~t cua tir nuoi cay;

+ 01 la QTC d~u tien ducc khoa vi sinh bien soan, diroc danh s6 tlnr tir Ia

01.

2.1.4. Phien ban (thir tl,I cua l~ ban hanh): C~ danh s6 thir tu tang d~

m6i lk ban hanh QTC va ghi bkg chii s6 A-r~p, vi d\l:

Khi bien so~ m6i quy trinh "KiSm soat tili li~u" vao nfun 2014 thi phi en

ban d~u tien leY hi~u Ia 1.0. Trong nfun 2015 co sua d6i I~ thil nh~t thi s6 phien

ban m6i se Ia 1.1 ho~c 2.0.

2.1.5. Ngay hi~u I\lc: Ghi ngay hi~u ll,l'ctren QTC sau khi da duQ'cban

hanh.

2.1.6. HQ va ten, chii leY va chilc V\l cua nguai bien so~, nguai kiSm tra

va nguai phe duy~t.

2.1.7. Theo d5i sua d6i QTC: Ghi thong tin vS vi~c sua d6i/b6 sung vS nQi

dung cua QTC thea hu6ng d§n bang sau:

10

Phien ban s6 Vi tri sua d6i NQidung sua d6i Ngay xem Ngiroi xem

xet/sira d6i xet/sira d6i

2.2. Til' trang tlnr 2 tro di cua quy trinh thirc hanh chuan, duoc trinh bay

nhu sau:

Ph§.n dAu trang (header) va phan chan (footer) trang se xuftt hien a m6i

trang cua QTC, phan nay bao gom: ten QTC, rna tai lieu, phien ban va s6 tlnr

tv/t6ng s6 trang, vi du:

Ph§.ndAutrang duoctrinh bay nhu sau:

Huang d~n bien soan quy trinh thirc hanh chuan Ma tai lieu: QLCL-01

Phan chan trang diroc trinh bay nhu sau:

IPhien ban: 1.0 Trang: 2/5Ngay hieu luc:

3. Cach danh s6 cho cac c~p dSmuc:

3.1. DS muc chinh duoc danh s6 A r~p va in d~, vi du: 1.,2., ....

3.2. Cac dS rnuc phu duoi dS muc chinh diroc danh s6 tang d§.nthea s6

thir tv cua dS muc chinh nhir sau:

- Cftp 1 in d~ nghieng, vi du: 1.1.,1.2., ...

- Cftp 2 in thirong, vi du: 1.1.1. , 1.1.2., ...

- Cac cftp tiSp thea in thuang, vi d\l 1.1.1.1., 1.1.1.2 ....

- Cac y chinh du6i cac dS m\lc chinh ho?c ph\l dung ki hi~u g~ch dAu

dong (-).

- Cac y nhe tiSp sau y chinh ki hi~u dftu cQng (+) va tiSp dSn kY hi~u dftu

chftm (e).

Vi d\l:

1.H~ th8ng quan Iy chit IU'gng

1.1. Yeu cOu v€ h? thDng tai Ii?u

f)~ m\lC c~p 1

f)~m\lC c~p2

11

NQi dung cdp 2

N Qi dung cdp 3

1.1.1.Khai quat

1.1.2. Ki6m soat ali li~u1.1.2.1. Ki6m soat Uti lieu nQi bQ

- S6 tay chdt hrong

- Quy dinh, Quy chS

- Quy trinh

+ Bi6u m§:u

• Bi6u m§:u ngang

• Bieu m§:u dQC

1.1.2.2. Kiem soat ali lieu ben ngoai

De muc cap 3

D~muc cdp 4N Qidung cdp 1

Il, Yeu cfiu v~ nQidung tBi thi~u ciia quy trinh thuc hanh chu§n

1.DBi vrriquy trinh th\fc hanh chu§n ky thu~t bao gBm cac nQi dung

sau:

1) M\lc dich;

2) Pham vi ap dung;

3) Trach nhiem;

4) Dinh nghia, thuat ngtt va chir viSt tilt;

5) Nguyen ly;

6) Trang thiet bi va v~t tu;

7)KiSm tra chit hrong;

8) An tom;

9) N9i dung thirc hien;

10) DiSn giai kSt qua va bao cao;

11) LUll Y (canh bao);

12) LUll tm he, sa;13) Tai lieu lien quan;

14) Tai lieu tham khao,

12

7. Ki~m trach~ t IU'Q'ng

- Mo ta cac phuong phap kiem tra chAt hrong bao g6m hoatdQng hieu chuan may va thirc hien nQi kiem (vi du sir dungm~u chimg, m~u chuan, biSu d6 kiem tra chat hrong ... ).

- Truong h9P da co quy trinh rieng vS viec hieu chuan maythi khong cilil diSn giai chi tiSt trong muc nay. CAnghi tenva rna cua quy trinh lien quan

- Neu gioi han nguong vS kSt qua nci kiem va cac hanhdong kh~c phuc khi nQi kiem khong dat.

8. An toan Neu cac vAn dS an toan cAn hru y khi thirc hien quy trinh(nSu co).

9. NQi dungthuc hi~n

9.1.Chu8n bi (khong tip dung cho QTC quan Iy)- Neu cac bircc chu§n bi cAnthiSt (chuan bi sinh pham/hoachAt, van hanh may, thirc hien nQi kiSm tra .... ) ck th\fchi~n truac khi tiSn hanh cac buac chinh. ' -

- Cac buac chuftn bi nay co thS 16ng ghep vao qua trinhth\fc hi~n hay tach thanh mQtm\lc rieng.

Luu y: NSu da co quy trinh rieng cho v~n hanh may vahi~u chuftn lien quan dSn QTC co thS d~ chiSu ten quytrinh, rna tai li~u tuong (mg.

Vi d¥: Vgn hcmhva hi¢u chudn may thea QTC rna sciXY­QTKTTB-039.2. Cac hUdc tk,!,chi?n:

-Neu trinh t\f cac buac th\fc hi~n chinh, viSt C\l thS, ng~gQn, dS hiSu.

-Danh s6 thu t\1 cho timg buac th\fC hi~n dS khi d.n thiStth\fc hi~n l~p l~i cac buac dS dang, tranh nhAri11~.

Vi d¥: Niu cac buoc th'lfc tuang tlf nhu th'lfchi?n mdu n9i!dim thi chi can ghi la tuang t'lfnhu m¥c 9.3 ....

10. DiSn giaiva bao cao k~tqua

- Neu ra kSt qua thu duqc

- Neu ro cach thuc giai quySt khi co S\I c6

- D6i vai QTC ley thu~t ck ghi them cac thong tin sau:

+Neu cong thuc tinh, don vi sir d\lng (nSu co)

+Bi~n lu~ kSt qua cho nhUng truOng h9P bAtthuOng

+Neu ra khoang giai h~ cua h~ th6ng ph§.ntich va khoang15

tham chieu sinh hoc va gia tri bao d9ng (neu co).

11. LUll Y Ghi ~iing sai l~ch co th~ xay ra hoac nguyen nhan gay sai(canh bao) lech ket qua va gioi han cua xet nghiem,

12. LUll trfr h8 Ghi sB va ghi van cac bi~u mfiu lien quan dSn quy trinh va,SO' hru trii ho sa.

13. Tai li~u Liet ke cac QTC, bi~u mftu lien quan bao gBm ca rna tailien quan li~u

14. Tai li~u - Liet ke ten cac tai lieu tham khao, huang d§n chuyentham khao men trong qua trinh bien soan (cac tai li~u tieng vi~t tnroc,

sau do dSn tai lieu mroc ngoai)

- B6i voi m6i tai li~u tham khao c§n neu cac thong tin theatrinh tv nhu sau: Ten tac gia; Ten tai lieu; L§n xuftt ban;Ten nha xuat ban! noi xuftt ban; Nam xuftt ban; Ten d@muc phdn tham khao; Trang tham khao,

Vi du: Quy trinh wjn himh va thvc hi¢n xet nghi¢m trenmay FACSCount - nom 2009, Lim xudt bim thu 3 - Ha N9i,2012, trang 33-37.

Ir- ~j

16

TAl LI¥U THAM KHAo

Ti~ngVi~t

1. Thong nr s6 0112013/TT-BYT, ngay 11/0112013cua BQ tnrong BQ YtS, Huang din thuc hien quan ly ch~t hrong xet nghiem tai co sa kham benh,chua benh,

2. Quyet dinh s6 3701lQD-BYT, ban hanh "Chuang trinh hanh dQng quocgia vS nang cao nang 19c quan ly phong xet nghiem y h9C ill nay dSn nam2020".

3. Tieu chu§n quoc gia, 2014, Phong thi nghiem y tS- Yeu c~u cu thS vSch~t hrong va nang 19c CTCVN7782:2014-ISO 15189:2012), Ha NQi.

4. Thong nr s6 01/2011ITT-BNV, ngay 19 thang 01 nam 2011 cua Be;,NQivu, Huang dfrn thS tlnrc va ley thuat trinh bay van ban hanh chinh,

Ti~ngAnh1. World Health Organization, 1997. A WHO guide to Good

Manufacturing Practice (GMP) requirement, Part 1.' Standard OperationProcedure and masterformulae, p12-111

2. Clinical and Laboratory Standards Institute, 2002. Clinical laboratoryand technical procedure manuals; Approved guideline 4th Edition. GP2-A4Appendix A. Suggested Contents of Laboratory Procedures. NCCLS: Wayne,Pennsylvania, p.19.

3. United States Environmental Protection Agency, 2007. Guidance forPreparing Standard Operation, 2007, p 6-60.

4. World Health Organization, 2011. Laboratory Quality ManagementSystem =Handbook, Document and Record, p.181.

5. World Health Organization, 2011. Laboratory Quality Standards andtheir Implementation-South-East Asia Region, Annex 5, p39-45.

6. ISO 15189:2012, Medical laboratories - Particular requirements forquality and competence, 2012.

7. Clinical and Laboratory Standards Institute, 2013. Quality ManagementSystem- Development and Management of Laboratory Documents; Approvedguideline 6th Edition, p.9-1 O.

17

PhulucIDANH MVC TEN cAe QUY TRINH CHUAN QUAN LY QuAN LY

CHAT LUQNG xET NGHlt:M!rI

1. Quy trlnh chuin chilt hr9'Dgtrong qmin Iy

STT1

23

45

67

- ,

8

910

1112

1314

15

1617

18

19

20

212223

24

25

TENQUY TRiNHQuy trinh huang & bien soan quy trlnh thuc hanh chufut

Quy trinh ki~m soat tai li~uQuytrlnh ki~m soat hB saQuan 1y nhan str va dao tao nhan vienQuy trinh daub gia Dang luc nhan vienQuy trinh quan ly h6 sa nhan s\!,Quy trinh quan ly trang thi~thiQuy trinh quan ly sinh ph~m va v~tnr tieu hao

Quy trinh quan ly S\I khong phil hopQuy trlnh danh ghi SI!hsi long cua khach hang

Quy trinh giai quyet khieu nai

Quy trinh Iva ChQ11va danh gia nha cung cdp

Quy trinh bao m~t thong tinQuy trinh danh gia nQi b9Quy trinh thirc hi~n cac hanh dQngkh~cphucQuy trinh tlnrc hien cac hanh dQng phong ngira

Quy trlnh hop xem xet cUa lanh ~o

Quy trinh trao d6i thong tinQuy triOOllJa chQnva danh gia phong xet nghi~tn chuy8n gUi m§u

Quy triOOdanh gia nguy co.'. ,

Quy trinh xac djnh va theo d5i chi so chat IUQ11g

Quy trlnh xem xet kat qua hi~u chuin

Quy trinh trinh xung dQt quy~n19iI.----I-_:::__:__------=-__:___:::__;__-----'"

Quy trinh lUll mdu sau xet nghi~m

Quy trinh cai tieri lieD We'''".,,''" --i

26 Quy trinh xU ly sau phoi nhiSm27 Quy trinh tAng ket va bao cao kSt qua

28 Quy trinh dao tao va danh gia hi~u quan sau dao tao

29 Quy trinh ki~m tra chftt hrong hang hoa

30 Quy trinh ling phe v&i tinh hu6ng khful c~p

STT TEN QUY TRiNH KY THU~T1 Quy trinh thirc hi~n cac xet nghiem (mBi loai xet nghiem mQt quy

trinh rieng vi du: Quy trinh xet nghiem ham hrong glucose trongmau)

2 Quy trlnh l§.y mdu mau tinh mach3 Quy trinh lAymAumau mao mach (dAu ngon tay)

5 Quy trinh v~ sinh va bao dirong du phong thi~t b]

6 Quy trlnh xu ly rae thai7 Quy trinh dong goi va v~n chuyen mau benh phfun

8 Quy trinh chuan bi mdi tnrong thach thirong

9 Quy trinh chuful bi moi tnrong thach mau10 Quy trinh ti~p nh?n, illch6i va bao quan mau· henh phfun

11 Quy trinh phan tich ket qua DQi kiSm12 Quy trlnh hm gift chimgvikhutn

13 Quy trlnh cAy mau14 Quy trinh ciy phan15 Quy trinh cAyb~nh phfun dUOng ho Mp

BENH VISN £>AKHOA TINH XYZ Mil s6: XX-QTQL-Ol£>~tLogo KHOA xET NGIIIEM XXX Phien ban: 1.0

(nSu c6) QUYTRiNHNgay ban hanh: 15/05/2014S6 trang/tong trang: 1/10

KIEM SOAT TAl Ln::U

Ngmyi bien soan Ngum xem xet NguiYiphe duy~t

Ho ten Nguyen Thanh B Phan£>inh C r.s Van A

Ky ten

Ngay ...... / ...... / ......... ...... / ...... / ......... ...... / ...... / .........!

THEO DOl SUA DOl TAl Ln::U

Phien Vi tri sua d8iNQidung sifa doilxem Ngay sira NguiYi sua

ban/xem xet xet d8i1xem xet d8i1xem xet

Tid lieu noi b9

PHVCLVCll-A

MAU QUY TRINH THl/C IIANHCHUAN KIEM SOAT TAr L~U

Quy trinh kiem scat tai 1i~u Khoa xet nghiem xxPhien ban: 1.1 Ma so: XX-QTQL-Ol

1. M1}c dich

- Huang dftn cu thS cac quy dinh vS quan 1ytai lieu ban gi~y ben trong (noi bQ)

va tai lieu ben ngoai cua h~ thong ch~t hrong nham dam bao cho nhan vien

trong khoa co sfu1cac quy dinh va quy trinh hien hanh dS thuc hien,

2. Pham vi ap dung

- Ap dung tai cac phong thuoc khoa xet nghiem XX- Benh vien Da Khoa XXX

khi thirc hien quan ly tai lieu ban gi~y ben trong va ben ngoai.

3. Trach nhifm

- T~t ca cac phong thuoc khoa xet nghiem XX co trach nhiem thuc hien kiem

soat tai lieu thea dung quy dinh.

- Can bQquan ly chat hrong co trach .nhiem quan Iy, hu6ng dfuIva giam sat thirc

hien quy trinh.

- TruOng khoa co trach nhi~m quan ly chung vS tai li~u.

4. Djnh nghia va chii'vi~t t~t

4.1. lJjnh nghia

- Tai li~u: cac van ban huang dful (ban gi~y ho~c di~n ill) bao g6m quy diM,

chinh sach, quy trinh, biSu m~u, bao cao, biSu m~u. Tai li~u co th6 0 d~g van

ban, di~n ill.

- Tai li~u nQibQ: S6 tay ch~t luQTIg;S6 tay an toan; Quy trinh quan ly; Quy trinh

Icy thu~t, Hu6ng dfuI cong vi~c, Hu6ng dful thi~t bi, Mu6ng dful an toan va cac

bi6u m~u ap d\lllg. H6 sa khong nfun trong ph~ vi nay.

- Tai li~u ben ngoai: hi tai li~u duQ'cthi~t l~p va ban hanh boi cac t6 chuc ben

ngoai bao g6m cac van ban quy ph~m phap lu~t, tieu chu§.nqu6c t~, tieu chuful

qu6c gia, van ban cong nh~, chUng nh~, tai li~u hu6ng d~ cua nha san xu~t

va cac cong van hu6ng din.

Ngay hi?u 11!c: 15/05/2014Quy trinh nay chi mang tinh chat tham khao Trang 2/9

Quy trinh kiem soar tai li~u Khoa xet nghiem :xxPhien ban: 1.1 Ma:so: XX-QTQL-O1

- Tai li~u 16i thoi: la tai lieu da:hSt hieu hrc thi hanh hoac da:e6 phien ban moi

thay thS hoac theo lenh huy bo,

4.2. Chic viit tat- BM BiSum~u

- QLCL

- QLKT

- QTQL

QU8n ly chat hrong

QU8n ly Icy thuat

Quy trinh quan ly

5. NQidung thuc hi~n

5.1. Quy djnh v~ ban g8c va ban sao

5.1.1. Tai Ii?u ban g8c

C6 t§.tca cac chir ky nroi bing mire mau xanh cua nguoi bien soan, xem xet va

phe duyet.

C6 d§.u"BAN GOC" va d§.u"TAl LIl;:UKIEM SOAT" mau do tren trang d~u

tien, giap lai tren cac trang eon lai cua tai lieu. Tai lieu e6 hieu lire kS illngay

ban hanh,

5.1.2. Tdi Ii?u ban sao

- Ducc sao illban g<3enen t§.tca cac ehu ky, d§.u"BAN GOC" dSu bing mire in

mau den.

Phai e6 d§.u"BAN SAO CO KIEM SOAT" bing muc mall do 6 chinh gitra pillatren eua m6i trang. a phia duai ghi s<3thu tv eua ban sao b~ng mve mau xanh.

Cae tai li~u dam bao eae d~e diSm neu tren la tai li~u hqp phap eua h~ th<3ng

eh§.tlUQl1g.

5.2. Quy djnh v~ con diu

Ngay hi¢u hrc: 15/05/2014Quy trinh nay chi mang tinh chcit tham khao Trang 3/9

Quy trinh kiem soar tai lieuPhien ban: 1.1

Khoa xet nghiem xxMa so: XX-QTQL-Ol

STT

1

RET HIBuLVC

Ml}.C dich sir dungQuy eachMau

muc diu

BANGOC Do Khung hinh chii nhat - Dong tren ban goc

35x12mm - co chii "BAN cua tai lieu.

G6c" in hoa

2 BAN SAO

c6KffiMSOAT

Do Khung hinh chii nh~t - Dong tren ban sao

70x20mm - co chir "BAN cua tai lieu phan

SAO c6 KIEMSOAT" in ph6i cho cac don vi.,

hoa; "So: ..... " in thirong .

3 Do Khung hinh chii nhat - Dong tren tai lieu

49x17mm - co chi! "RET het hieu hrc hay

HIBu L1)'C" in hoa khong con phil hop

khi da co phien ban

moi ban hanh,

5.3. Kiim sodt tai li~u npi bp

5.3.1. Ban hanh tai lieu

- Sau khi tai lieu ducc Icy phe duyet, can b9 quan 1;' ch~t hrong thuc hien nhir

sau:

+ Ghi ngay co hieu hrc len tirng trang cua tai lieu;

+ Dong d§.u "BAN G6c" va d§.u"TAI L$U K.IEM SOAT" tren m6i trang tai

lieu a goc phia tren ben phai;

+ Thuc hien sao chep va pharr ph6i tai lieu dung thea muc 5.5.2;

Ngay hieu luc: 1510512014Quy trinh nay chi mang tinh chdt tham khao Trang 419

Quy trinh kiem soat tai lieu Khoa xet nghiem xxPhien ban: 1.1 Ma so: XX-QTQL-Ol

+ C~p nh~t ten tai li~u vao "Danh muc tai lieu nQi b9 co kiem soat" thea biSu

m~u ma s6 XX-QTQL-OI-BMOI va hru gift danh muc nay. Danh muc nay chi

thS hien cac phien ban till lieu co kiem soat dang hruhanh;

+ LUllgift ban g6c trong illco khoa tai phong thea muc 5.5.6;

+ Len kS hoach /~p huan hoac ph&bien cho nhan vien lien quan vS cac tai lieu

moi ban hanh.

5.3.2. Sao chep va phan ph6i tai lieu

- Chi can bQQLCL duoc quyen:

+ Sao chep va cung d.p tai lieu cua h~ thong ch~t hrong thea yeu cfiu cua cac

phong trong khoa;

+ In dung s6 hrong ban sao theo danh sach phan ph6i ducc neu trong tai lieu,

tnrong hop in b&sung ck co phe duyet cua tnrong khoa;

+Dong d~u "BAN SAO CO KIEM SoAT" va ghi s6 thu tlJ ban sao len m6i trang

II-I

cua bim sao;

+ Phan ph6i ban sao cua Uti li~u dSn cac dan vi/ca nhan co ten trong danh sach

phan ph6i. Khi giao tai li~u, nguai chiu trach nhi~m ph§.n ph6i tAi li~u phfti c~p

nh~t vao "S&thea d5i ph§.nph6i1thu h6i tAi li~u" thea biSu m~u ma s6 XX-QTQL-

03-BM03

5.3.3 Soat xet djnh ki

- Bfiu m6i quy nh§.nviSn QLCL co trach nhi~m l~p danh sach cae tai li~u cAnxem

xet trong quy do cua khoa va gai thong bao b~g van ban dS cac phong trong khoa

ra soat l'ilinQidung tai li~u cua don vi rninh.

- T~t cft tai li~u se duQ'cra soat l'ili1 namll§.n.

-Nguai ra soat diSn vao "PhiSu soat xet tai li~u djnh k)'" thea biSu rn~u rna s6 XX-

QTQL-OI-BM05.

Ngay hi?u hlc: 15/05/2014Quy trinh nay chi mang tinh chdt tham khao Trang 5/9

Quy trinh kiem soat tai lieu Khoa xet nghiem xxPhien ban: 1.1 Ma so: XX-QTQL-Ol

- N~u sua d6i, thuc hien theo trinh tu sua d6i tai lieu quy dinh trong muc 5.2.3.

5.3.4 Sua d6i va till ban hanh tai li~u

- Tftt cit nhan vien co thS dS nghi sua d6i tai lieu, Nguoi dS nghi se diSn vito "PhiSu

dS nghi bien soan/sua d6i tai lieu" theo bieu m~u rna s6 XX-QTQL-OI-BM04.

- N9i dung sua d6i se duoc nguoi co tham quyen xern xet va phe duyet nhu bang

sau

TT Loai tii li~uTrach nhiem

Bien soan Xem xet Phe duy~t

1 S6 tay chit hrong (STCL)Quan ly chit

Tnrong Khoa Lanh daohrong

Quan ly chitLanh f)~o

2 Quy trinh quan ly (QTQL) Truong Khoa hoac tnronghrong khoa

3Quy trinh xet nghiem Tit ca nhan

Quan .ly ky thuat Tnrong Khoa(QTKT) vien

4 S6 tay an toan (STAT)Quan ly chit

Tnrong Khoa Truong Khoa1ugng

Hu6ng dan (HD), bieuTit ca nhan

5 m~u (BM), s6 ghi chep Truong b9 ph~ TruOngKhoa."(SGC)

VIen

- Ngum sua d6i c~p nh~t thong tin sua d6i vito bang "Theo d5i sua d6i titi li~u" (]

trang dAu tien cua tai 1i~u. N9i dung sua d6i trong titi 1i~uphiti gc;lch(] ngoiti IS

phiti.

- Khi ban hanh titi 1i~u rnai, QLCL ti~n hanh thu h6i titi li~u cli theo quy trinh (]

m\lc 5.2.5.

- QLCL phan ph6i 1c;lititi li~u da sua d6i cho cac dan vi/ca nhan thich hgp. C~p

nh~t vito "Danh m\lc titi Ii~u n9i b9 co kiSm soat" theo biSu m~u rna s6 XX-QTQL-

Ngay hi?u hcc: 15/05/2014Quy trinh nay chi mang tinh ch6t tham khiio Trang 6/9

Quy trinh kiem soat tai lieu Khoa xet nghiem xxPhien ban: 1.1 Ma so: XX-QTQL-OI

OI-BMOI va "S6 thea d5i phan phoi/thu h6i tai lieu" thea biSu rn~u rna s6 XX­

QTQL-4.3-BM03.

5.3.5. Sir dung tai li~u

- Can b9 QLCL hru giu b9 tai lieu g6c. Nhan vien khoa chi sir dung ban sao hoac

ban di~n tiro

- Rieng voi cac bieu rn~u trong dung dS diSn thong tin, QLCL se in 01 ban cho rn6i

loai bieu rn~u va dong diu "TAr L$U K.IEM SOAT" VaGmat sau cua bi~u rn~u

trong va dS trong cap file "BiSu rn~u sir dung" cho nhftng nguoi lien quan sir dung.

Nguoi sir dung co thS tao nhieu ban sao illbieu rn~u co kiem scat nay.

- Ngiroi sir dung phai kiem tra/ddi chiSu dS dam bao sir dung dung phien ban c~p

nhat nh~t cua bieu rn~u.

- Nhtrng bieu rn~u trong sau khi diSn thong tin se tro thanh h6 sa va duoc quan ly

theo quy trinh "Quan ly h6 So''' rna s6 XX-QTQL-IO

5.3.6. Thu h6i va huy tai li~u

- Phai thu h6i tai li~u co kiSrn soat da hSt thai gian hi~u h,l'c,phien ban cli cua tai

li~u da sira d6i, ho~c tm li~u khong con sir d\lllg. C~p nh~t vao "S6 thea d5i phan

ph6i1thu h6i tai li~u" thea biSu rn~u rna s6 XX-QTQL-OI-BM03.

LUlly: Khoa se khong thu h6i cac ban sao khong kiSrn soat.

- Bong diu "RET IIIBuL1)'C" rnau d6len tai li~u da thu h6i va ghi ngay hSt hi~u

l\Ic.

Khi huy tai li~u (d~g van ban ho~c di~n tir) phai dam bao tai li~u khong co kha

nang ph\1ch6i va chi duQ'chuy khi da co phien ban rn6i thay thS va thai gian lUll

tm da dUngquy dinh

- C~p nh~t thong tin huy tai li~u vao "PhiSu huy tai li~u" theo biSu rn~u rna s6

XX-QTQL-03-BM06

Ngity hi¢u lvc: 1510512014Quy trinh nay chi mang tinh chdt tham khao Trang 719

Phien ban: 1.1 Ma so: XX-QTQL-OlQuy trinh kiem scat tai li~u Khoa xet nghi~m xx

- Luu gift mot ban (ban gBe) it nhAt3 nam sau khi huy.

5.5. Kiim sodt tai Ii?u ben ngoai

5.5.1. Nhan dang tai lieu_ Khi tai lieu ben ngoai chuyen den don vi, QLCL se e~p nhat vao "Danh muc tai

lieu ben ngoai co kiem soat" thea bieu m~u rna sBXX-QTQL-OI-BM02, dong dAu

do "TAI L!BU KIEM SoAT" a trang dAu cua tai lieu va giao eho nguoi co lien

quan xu ly, quan ly hoac trinh lanh dao don vi giai quyet.

_Voi nhimg tai lieu ben ngoai co lien quan den h~ thong QLCL, nguoi co thfun

quyen phai e~p nhat va ph6 bien den tAt ca nhan vien thea quy trinh "T6 chirc va

trach nhiem quan If' rna sB:XX-QTQL-05.

5.5.2. Luu gifr va quan ly tai lieu -

_ Luu gift tai lieu phai thea chungloai, trong nhfrng cap tai lieu rieng va co d~u

hieu nhan biet dS dS dang tim kiem khi cAnthiet.

_ Nguai chiu treich nhi~m luu gifr tai li~u quyet diM vi~e cho phep sao chep tai

li~u._Cac tai li~u khong con cAnthiet, het hi~u Ivc ho~c da duQ'Cthay the phai dong dAu

":H:ETHIBu LVC" va ghi ngay len tai li~u.

- Quy trinh thu h6i va huy tai li~u tuong t\{ nhu mlfc 5.2.5.

5.6. Tai Ii?u khong kiim sodt- Tai li~u khong kiSm soat Ia tili Ii~u khong phai ban gBc ho~e ban sao nhung

khong co dAu"BAN SAO" mau do.

- Khi phan phBi mQt sBtai Ii~u khong kiSm soat, co thS su dvng biSu m~u "S6 thea

doi phan phBi/thu h6i tai li~u" thea biSu m~u rna sBXX-QTQL-O I-BM03 neu cAn

thiSt.

6. LlfU trfr h& SO'

Ngayhi¢u hrc: 15/05/2014Quy trinh mlY chi mang tinh chelt tham khao Trang 8/9

Quy trinh kiem soat Uti lieu Khoa xet nghiem XXPhien ban: 1.1 Ma so: XX-QTQL-Ol

Ghi chep dAy dit cac thong tin vao cac bieu miu lien quan duoi day:

- Danh muc tai lieu n9i b9 co kiem scat

- Danh muc tai lieu ben ngoai co kiem soat

- S6 thea d5i phan phoi/thu h6i tai li~u

- PhiSu dS nghi bien soan/sua d6i tai li~u

- PhiSu ra soat/xem xet tai lieu dinh ky

- Phieu huy tai lieu

7. Tai li~u lien quan

XX-QTQL-OI-BMOI

XX -QTQL-O 1-BM02

XX-QTQL-OI-BM03

XX-QTQL-O 1-BM04

XX-QTQL-O 1-BM05

XX-QTQL-OI-BM06

STT Ten tai li~u MasB1 Quan Iy ho sa ,.... ~... XX-QTQL-I02 To chirc va trach nhiem quan ly XX-QTQL-058. Tai li~u tham khao

8.1. Ti~ng Vi~t .

- Tieu chuan quoc gia, 2012, Phong thi nghiem y tS- Yeu cAucu thS vS ch~t hrong

va nang I\l'C (TCVN 7782:2012-1S0 15189:2012), Ha N9i.

8.2. Ti~ng Anh

- WorId Health Organization, 2011, Laboratory Quality Management System -

Handbook, Document and Record, p.190-196.

http://whglibdoc. who.intipublications/20 1119789241548274 eng.pdf

- ISO 15189:2012, Medical laboratories - Particular requirements for quality

and competence, 2012.

Ngay hieu luc: 15/05/2014Quy trinh nay chi mang tinh cMt tham khao Trang 9/9

BBNH V$N DA KHOA TINH XYZ Mii s6: XX-QTKT-06D~tLogo KHOA xET NolIIBMxx Phien ban: 1.0

(nSu CO) QUYTRINH Ngay ban hanh: 1511012014

NHUQM SOl TRljC TIEP TiM AFB

NgU'iribien soan NgU'irixem xet NgU'iriphf duy~t

Ho ten NguyenVanA Le Thi C Tran VanB

'.'

Ky ten

Ngay ...... I ...... I ......... ...... / ...... I ......... ...... I ...... I .........

THEO DOl XEM XET/SU'ADOl TAl LI¥V

Phien ban so Vi tri sua doi NQidung sua Ngay xem xeti NgU'irixemd6i sUa d6i

..xeti sUa doi

r;,; us, "Mr.; 'hA

PHVLVC II-BMAV QUYTRINH Twe IIANH CHVAN vE

NHVOM SOl TRUe TrEP TIM AFB. .

PHULUCll-BMAu QUY TRiNH TH\1C HANHCHUAN vE

NHUOM SOl TRUC TIEP TiM AFB. .B$NH VI$N DA KHOA TINH XYZ

Mii s6: XX-QTKT-06Dat Logo KHOA xET NGIII$M XX Phien ban: 1.0(neu c6) QUYTRiNH Ngay ban hanh: 1511012014

NHU(>M SOl TRVC TrEP TiM AFB

Nglfiri bien soan Nglfiri xem xct Nglfiri phe duy~t

H9 ten Nguyen Van A Le Thi C Tran Van B

•.• >tP'tKyten

Ngay ...... I ...... I ......... ...... I ...... I ......... ...... I ...... I .........

THEO DOl XEM xET/SUA DOl TAl LI¥U

Phien ban s8 Vi tri sua doi NQidung sua Ngay xem xct! Nglfiri xem.,.sua dai

.,.doi xet! sfra doi

rA; us., 2I1Ai J...A

Quy trinh xet nghiem dam tnrc tiep AFB bang phirong Khoa xet nghiem xxphap nhuom Ziehl-NeelsenPhien ban 1.0 Ma tai lieu: XX-QTKT -06

1. M1}cdich

- Mo ta va huang d§n each thuc hien xet nghiem dam tnrc tiSp tim AFB bang

phirong phap nhuom Ziehl-Neelsen.

2. Pham vi

- Ap dung tai khoa xet nghiem XX - Benh vien Da Khoa XYZ.

3. Trach nhi~m- Nhan vien diroc giao nhiem vu thuc hien .xet nghiem nay tuan thu dung quy

trinh.

- Can bQ QLCL, t6 tnrong chuyen mon chiu trach nhiem giam sat viec tuan thu

quy trinh va nhan dinh kSt qua xet nghiem,

4. Djnh nghia va tir vi~ttitAFB Acid fast bacilli True khuan khang c6n, khang axit thuoc ho

Mycobacteriaceae

BCDN

ZN

BCDN

Bach d.u don nhan

Zeihl-Neelsen

Bach c~u da nhan

5. Nguyen ly

- Phuong phap nhuom Ziehl-Neels en la phirong phap su dung 2 hoa chit nhuom

mau la do fuchsin va xanh methyl en kSt hgp v&ichit tAymau (h6n hgp acid HCL

va c6n 96°) dB phat hi~n AFB. Phuong phap nay dugc su d\ll1gde phat hi~n cac vi

khuftn thuQc hQMycobacteriacae la cac vi khuftn co d~c diem khang c6n, khang

acid. ChUng co thS t6n t?i trong moi truOng co n6ng dQ c6n, acid nhit diM va

khong bi mit mau khi tAybfu1gc6n va acid.

6. Thi~t bi va vat lieu. ..6.1. Thill hi

-_,--_--------- ._-_.__ ._..._.. ,_,--,---,---,,- _- _._--.__ ._-----,._, .._--------_ ..-_._--_._--------_._,---_ ..__ .._--Ngay hi?u !t:lc:1511012014Quy trinh nay chi mang tinh chat tham khao Trang 218

Quy trinh xet nghiem dam tnrc tiep AFB bang phirong Khoa xet nghiem :xxphap nhuom Ziehl-NeelsenPhien ban 1.0 Ma Urilieu: XX-QTKT-06

- Kinh hien vi quang hoc 2 mat voi v~t kinh 100X, lOX

- Til an toan sinh hoc c~p 1

- B6ng h6 phut

6.2. V~tli~u

6.2.1 Dung cu

- Lam kinh co d~u rna- But chi den HB

- C6c nhua dung dam

- Que g6 phet dam dung 1 l~n

- Gia nhuom tieu ban

- Giay 1aukinh

6.2.2 Roa ch~t

- Dung dich Fuchsin 0,3%

- Dung dich c6n t~y RCL 3%

- Dung dich xanh Methy1en 0,3%

- Dung dich sat khuan Phen015% hoac Javen 0,5%

- D~u soi kinh

6.2.3. M~u benh pham:

- Dam dung trong 6ng nlnra sach vo trung co nApd~y.

7. An toan

- Ap dung cac bien phap an toan chung khi xu 1;'m~u va thuc hien xet nghiem

thea quy trinh vS an toan xet nghiem rna s6 :XX-~~L-I0.

- Cac thao tac ley thu~t phai nhe nhang tranh tao hat mu khi rna nAp1Qdam, l~y

m~u dam, dan tieu ban va khi c6 dinh tieu ban chua kho hoan toano

8. N9i dung th1!c hi~n

-------- -- ------------- ---------------------- ---Ngay hi?u blc:15/10/2014Quy trinh nay chi mang tinh chdt tham khao Trang 3/8

Quy trinh xet nghiem dam true tiep AFB bang phirong Khoa xet nghiem xxphap nhuom Ziehl-NeelsenPhien ban 1.0 Ma tai li~u: XX-QTKT-06

8.1. Chuan bi

- Khoi dQngtil an toan sinh hoc it nhM 15 phut truce khi thuc hien

- S~p xSp cac dung cu dn thiSt vao til an toan sinh hoc

- Chon lam kinh sach, khong xiroc, Ho lam kinh qua ngon Ilia den cdn d@huy

ch~t dAucon dinh tren lam kinh, dS nguoi,

- Danh d~u bang each dung but chi den HB ghi rna sBbenh pham len dAurna lam

kinh.

- SSp cBcdam va lam kinh thea ill tv dS tranh nham l~n

Luu y: 86 xet nghiem phai i16ngnhdt giua s6 xet nghiem, phieu xet nghiem, c6c

Gam va lam kinh

8.2. Dim tieu ban:

Thuc hien trong til an toan sinh hoc

- M6 n~p cBcdam nhe nhang, d~t n~p ngira tren khay inox

- Dung dAuvat cua que phSt bang chon l~y ch6 dam nhAy rnu nh~ nhang c~t mAu

dam b~ng cach di c~ vat que g6 vao thanh cBc dam (lUll y: m6i b~nh phfun

dUngque phSt rieng)

- D~y n~p cBcdam

- D~t que phSt co m~u b~nh phAmvao giua lam kinh va dan trai thea vong xo~n

Bc ill trong ra ngoai, dan deu d~ lien tvc t~o dQmin day vira phai hinh 0 van

kich thu6c dai 2 cm rQng 1cm.

- Ngfun que phSt sau khi dan vao dung djch sat khufuJ phenol 5% ho~c Jave

0,5%.

Luu y: Chi hity b6 19 aam sau khi eta tra k~t qua xet nghi¢m.

8.3.Lam kho tieu ban:

-- -_ .._--------------------------_ .._------ ----Ngay hi¢u hrc:15/10/2014Quy trinh nay chi mang tinh chat tham khao

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Trang 4/8

Quy trinh xet nghiem dam t11ICtiep AFB bang phuong Khoa xet nghiem :xxphap nhuom Ziehl-NeelsenPhien ban 1.0 Ma Utilieu: XX-QTKT-06

- D~t tieu ban len mam kinh va de tieu ban kho nr nhien hoan toan a nhiet dQ

phong (18-25°C).

Ltru y: Khong lam kho tieu ban bang den c6n hoac anh nang m~t troi,

8.4. cs dinh lieu ban:

- Thuc hien ben ngoai til an toan sinh h9C

- Ho nong tieu ban qua hilitren ngon lira den c6n 3-4Idn, m6i ldn 3 giay.

Luu y: Khong c6 dinh khi tieu ban chua kho hoan toan.

8.5. Nhusm mau

- D~t tieu ban len gia nhuom

- Phu d~y dung dich Fuchsin 0,3% len m~t phet tieu ban da duoc c6 dinh,

- Ho nong tren ngon lira den c6n den khi b6c hoi (khong duoc dS soi) 1 l~n.

- DSnguoi tv nhien trong 5 phut.

- Rira diroi voi mroc chay nhe.

8.6. Tizymau

Phu d~y dung dich c6n t§.yHCL 3%.

DSyen tieu ban trong 3 philt.

Rira du&ivoi nu&c chay nhtt.

T§.yl~i ldn 2 (1-3 philt) neu tieu ban con mau h6ng.

8.7. Nhu~m nJn:

Phu dung dich xanh Methylen 0,3% trong 1 philt.

Rira du&ivoi nu&c chay nhtt (luu y: Kh6ng x6i vdi nuac thang vao vit dan)

DBkho tv nhiSn a nhi~t dQphong.

8.8. D(Jckit qua:

Soi tieu ban b~g vi~c su d\mg kinhhiBn vi quang h9Cv~t kinh dAu 100X thea

huang dful su dvng kinh hiBnvi v~t kinh dAurna XX.lID.03

-~.-- ..---.-----.--.--------.Ngay hi¢u l1!c:1511012014Quy trinh nay chi mang tinh chat tham khao Trang 5/8

Quy trinh xet nghiem dam true tiep AFB bang phuong Khoa xet nghiem xxphap nhuom Ziehl-NeelsenPhi en ban 1.0 Ma tai lieu: XX-QTKT-06

+ Duong tinh: AFB la tnrc khuan hinh que, manh, hill cong, bit mau do

Fuchsin, dimg rieng Ie, tirng doi hoac thanh tirng dam tren nSn xanh.

+ .Am tinh: Khong tim th§.y AFB.

9. Ki~m tra ch§t 1U'Q11g:

Theo 6 tieu chuan sau:

9.1. Chat luong b?nh pham:

- Quan sat: t6t nh§.t la benh pham co nhay mu, khong mroc bot, khong co mau,

- Tieu chuan khi soi kinh:

+ Co 25 BCBN/1 vi tnrong (soi v~t kinh lOX, thi kinh lOX).

+ Co 3-4 BCDN/I vi tnrong (soi v~t kinh 100X, thi kinh lOX).

+ Hoac co dai thuc bao,

9.2. Kich cOmdu b?nh pham tren lam kinh:

- Hinh ovan nam 6 giira lam.

- ChiSu rong I em, chieu dai 2 cm.

9.3. lJ~ min

- BS m?t tieu ban lien tuc, dSu d~, khong bi rang, bong.

- Soi kinh: Cac vi tnrong lien tuc khong co nhieu vi tnrong r6ng dQ sang dSu.

9.4. lJ~ day

- DQ day tieu ban khoimg 0,04 mm. Kiem tra b~g cach khi tieu ban kho chua

nhuQrn de I to' gi§.y c6 in chu xu6ng du6i tieu ban cach 4-5 cm.

+ D~t: NSu nhin th§.y chu rna, co the dQCduQ'c

+ Qua day: Khong dQc duQ'c chu

+ Mong: Nhin chu ro.

- Soi th§.u chiSu sau cua tieu bim (vi truemg mau xanh sang).

Ngay hi¢u hlc:15/10/2014Quy trinh nay chi mang tinh chdt tham khao Trang 6/8

Quy trinh xet nghiem dom true tiep AFB bang phuong Khoa xet nghiem xxph~ nhuom Ziehl-NeelsenPhien ban 1.0 Mil tai lieu: XX-QTKT-06

- N~u tieu ban qua day: Nhi6u lap, soi khong thAu vi tnrong (vi tnrong mau xanh

t6i).

- N~u tieu ban qua mong: Cac vi tnrong thua thot (nen xanh nhat).

9.5.Nhusm va tay mdu:

- Soi kinh: AFB b~t mau do ra rang tren n6n mall xanh.

- Chua dat: Tieu ban nhin bang m~t thuong rna con mau do.

9.6. Dr sach:

- Soi khong thAycac can ban, c~ Fuchsin, tinh th@....

- N~u thay cac c~ bfuI c6 th@do thuoc nhuom d@lau hoac do ho n6ng qua Iau

trong qua trinh nhuom.

9. 7. each !dim tra:

- TftnxuAtkiem tra: hang ngay hoac it nhat 1 tufuvl IAn.

- Ki@mtra bang 1 tieu ban duong tinh d@d~m s6 hrong va mau cua AFB.

- Ki@mtra bang 1 tieu ban am tinh d@kiem tra bQthuoc nhuom va nguon nuoc c6

bi nhiSm AFB khong.

- Ghi k~t qua vaGs6 ki@mtra chAtluqng.

10. Di~n giai va bao cao kSt qua:

S8 IU'Q'IlgAFB Ket qua Phan Io~i

Khong AFBI 100 vi truOng "Am tinh

C6 > 10AFBI 1 vi truOngDuongtinh AFB 3 (+)

(Soi it nhAt20 vi truOng)

C6 ill 1-10 AFBI 1 vi truOngDuong tinh AFB 2 (+)

(Soi it nhAt50 vi truOng)

C6 ill 10-99 AFBI 100 vi truOng Duong tinh AFB 1 (+)

:--::--- ._---------_._---Ngay hi¢u 11:fc:1511012014Quy trinh nay chi mang tinh chcit tham khao Trang 7/8

Quy trinh xet nghiem dom true tiep AFB bang phirong Khoa xet nghiem xxphap nhuom Ziehl-NeelsenPhien ban 1.0 Ma tai lieu: XX-QTKT-06

Co ill1-9 AFBI 100 vi tnrong DuongtinhGhi so hrong AFB

cu thell 00 vi tnrong

Luu y: 1 dong lam tuong dirong 100 vi tnrong. Soi it nhat 3 dong.

11. LIfUY (canh bao):- AFB nhat mau co the do tAy qua lau ho~c nhuom chua du (thai gian, sue

nong),

- NSu AFB t6i mau co thS do nhuom nSn qua lau,

- M6i me nhuom khong nen qua 12 tieu ban, cac tieu ban dS each nhau it nhAt 1

cm.

12. Luu trfr h8 SO'

- Ghi chep r5 rang kSt qua va cac thong tin quy dinh vao phieu tra loi kSt qua va

s6 kSt qua xet nghiem dam tim AFB Liru trfr cac bieu m§:uphieu kiem tra chAt

hrong thea dung quy dinh cua khoa.

13. Ta] Ii~u lien quan:

Ten tai li~u M§ tal li~u

1. Quy trinh an toan phong xet nghiem XX-QTQL-I0

2. Hu6ng d§:nsir dung kinh hien vi v~t kinh dau XX.lID.03

14. Tili li~u tham khao:

- B9 Y te, Hu6ng d§:nquan ly b~nh lao, NXB Y hQc,2009.

- B9 Y te, Chuong· trinh ch6ng lao qu6c gia, Huang d§n quy trinh th\1'chanh

chuAnxet nghi~m vi khudn lao, 2012, trang 23-38.

Ngay hi¢u htc:15/10/2014Quy trinh nay chi mang tinh chdt tham khcio Trang 8/8