BQYTE CQNG HOA xA HQI CHU NGHlA VIT NAM l>(>c l~p - T\f do - H~nh phuc ~6: ___ .,-18 30 /QB-BYT Ha Nr)i, ngay 26 thang 5 nam 2014

-- l

;, (~ \ TE t-i;\ G lANG i GONG \(1\N !J . " :u_-__J!::}P--- QUYET I>JNH

_____ :~~.,_ __ ;g 9 1 S i~c ban h~mh "Htr6ng dn ghim sat, cti~u tra, phan tich, ctanh gia nguyen nhan phan ung sau tiem chting"

BQ TRUONG BQ Y TE Can cu Nghi dinh s6 63/2012/NB-CP ngay 3118/2012 cua Chinh phu Quy

dinh chuc nang, nhi~m vv, quy~n h:;tn va ca c~u t6 chuc cua B9 Y t~; Xet d~ nghj cua Vi~n tru6ng Vi~n V~ sinh djch t Trung uang - Chu tjch

H9i d6ng chuyen mon xay dlJilg cac Hu6ng d~n v~ W~m chung t:;ti Cong van s6 311/VSDTTU-TCQG ngay 24/3/2014;

Xet d~ nghi cua Cvc tru6ng Cvc Y t~ dv phong - B9 Y t~, QUYET I>JNH: l>i~u 1. Ban hanh kern theo Quy~t dinh nay "Hu6ng d~n giam sat, di~u

tra, phan tich, danh gia nguyen nhan phan ilng sau tiem chung". l>i~u 2. "Hu6ng d~n giam sat, di~u tra, phan tich, danh gia nguyen nhan

phan trng SaU tiem chung" la tai li~U hu6ng d~n dUQ'C ap dvng trong cac CO' sa tiem chung Nha nu6c va tu nhan tren ph:;tm vi toan qu6c.

l>i~u 3. Quy~t dinh nay c6 hi~u Ivc k ti.r ngay 01 /6/2014. Di~u 4. Cac 6ng, ba: Chanh Van phong B9, Chanh Thanh tra B9, Vv

tru

B(>YTE C

.-1 I I I I I I I I I I 1-1 I I 1--1 I I I I I Ia I I I I I I I I I I

Danh sach

PVSTC

2. Htr6ng din giam sat phan ll'ng sau tiem chung 2.1. SO' dA h~ thfing giam sat

H~ thfing bao cao tai bi~n n~ng sau tiem chong

Trong vong 24 gio phai gui bao cao b&ng van ban. Trong vong 24 gio, k~ tir khi xay ra tai bi~n n~ng sau @g1 ~.hc\mg..,p,h

I I

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3. Di~u tra tai bi~n n~ng sau tiem chung 3.1. Thanh phin doan di~u tra: theo quy dinh t~i Thong tu s6

2112011/TT-BYT ngay 07/6/2011 cua B9 Y t~ quy dinh vi~c thfmh l~p, t6 chuc va ho~t di~n rna s6 truemg hqp tai bi~n n~ng sau tiern bao gbm chfr vi~t t~t cua

tinh, huy~n va di~m tiem chung, cu6i cung la s6 thu tg truemg hqp tai bien t~i di~m tiem chung d6 duqc vit du&i d~ng s6 vi d\1 truemg hQ'P thu nh~t tai bien n~ng sau tiern chung t~i xa A huy~n B, tinh C: rna s6 duqc vi~t nhu sau: VNCBA01

- Cac bu&c di~u tra C\1 th~ nhu sau: TT Cac bU'O'c Hanh done

- Thu th?p h6 sa b~nh an (ho~c ghi chep v~ lam sang) - Ki~m tra h6 sa chi ti~t v~ b~nh nhan, tinh tn:mg di~n biSn

Xac minh cac sue khoe. 1 thong tin trong - Phong v~n can b() y tS ti~p nh?n, di~u tri truemg hQ'P tai

bao cao bi~n n~g sau tiem chimg, ra soat h6 sa benh an. - Thu th?p them thong tin con thi~u trong bao cao. - Xac dinh nhfrng truemg hqp khac cAn di~u tra.

2 Dieu tra tai bien n~ng sau tiem chimg - Tien su tiem chfulg.

2.1. Di~u tra va - Ti~n su benh t?t, bao g6m ti~n su v~ phim l!ng tuang w thu th?p thong tin ho~c nhf'mg tinh tr~g di l!ng khac.

- Ti~n su v~ gia dinh d6i v&i nhfrng phan trng tuang tl,r. tir b~nh nhan ho~c

- Phong v~n trvc ti~p ba m~ ho~c ngum cham s6c tre, ra nguainha

soat h6 sa lien quan t&i truemg hQ'P phan l!ng sau tiem chimg do ngum nha gift.

2.2. Dieu tra - B~nh su, mota lam sang, t~t ca cac xet nghi~m lien quan

truemg hQ'P tai d~n !ai bi~n p.~g sau tiem chimg va chAn doan. bi~n n~ng sau tiem chimg - Dieu tri, ket qua

- Di~u ki~n v?n chuy~n v~c xin, di~u ki~n bao quan hi~n t~i, 2.3. Di~u tra v~c tinh tr~ng bao quan l9 v~c xin, bang theo doi nhi~t d() tu xin nghi nga lanh.

-Bao quan v~c xin tru&c khi d~n ca say tS, ~hiSu tiSp nh?n v~c xin, the chi thi nhi~t.

2.4. Di~u tra - Nhfrng nguai da duqc tiem chling cling lo~i vac xin trong nhfrng ngum lien cling m()t bubi tiem chimg c6 phan l!ng hay khong? phan l!ng tuang W hay khong? quan

- Di~u tra dich V\l tiem chimg. 3 Danh gia thl,l'C hanh tiem chimg

3. 1. Danh gia dich - Danh gia diem tiem chling: Hoi, quan sat viec cung dip dich V\l tiem chimg, bao quan v~c xin. Vl,l b5.ng each hoi

- Cach bao quan v~c xin (k~ ca nhfrng l9 da rna), vi~c phan 3

I

I

I

I

TT Cac bU'(YC Himh dong phoi va huy b6 vac xin. - Cach bao quan va phan ph6i dung moi. - Vi~c pha hili chinh v~c xin (ky thu~t va thai gian su d\]llg sau khi pha). - Cach su d\illg va vo trimg barn, kim tiem. - Nhfmg chi tiSt v~ hufut 1uy~n thvc hanh tiem chfulg, v~ giam sat cac kY thu~t tiem chling. - Tu 1~: ngoai v~c xin con bf10 quan them nhfmg gi trong tu 1~ ( cfin ghi chep nSu co nhfmg 19 tuong tv duqc d~

c~nh nhfmg 1Q v~c xin co th~ nhfim 1ful); nhfmg lo~i v~c xin \ 3.2. Quan sat dich ho~c dung moi nao d cung v&i nhfmg 1o~i thu6c khac; co l9 v~c xin, sinh phfim y tS nao m~t nhan, qua h~n su d\illg 1 v1,1 tiem chling khong?

I - Thvc hanh tiem chling (hili chinh v~c xin, rna nut lQ, kY thu~t tiem, dam bao an toan barn, kim tiem, vm b6 nhfmg lQ da rna).

4 D~t gia thuySt - Nguyen nhan co th xay ra Kim tra gia - Truang hqp phan Un.g co phu hqp v6i gia thuyet? 5 thuySt - Chi l~y mfiu va yeu cfiu kim dinh v~c xin nSu nghi nga

nguyen nhan do v~c xin. - Hoan chinh phieu dieu tra.

6 KSt thuc di~u tra - KSt lu~ cua doan di~u tra. - KhuySn nghi.

3.3. LAy min v~c xin d~ ki~m djnh - Ldy mdu va yeu cAu kim dinh vAc xin: my thu

- Thu th~p m~u b~nh ph~m d kim tra nhim trung, min dich, mo b~nh hQC va Vi rut hQC theo hu6ng d~ CUa cac phong xet nghi~m lien quan va theo Phvlvc 4 cua Hu6ng d~ nay.

4. Phan tich k~t qua di~u tra tai bi~n n~ng sau tiem chting 4.1. Nh~p s& li~u theo cac bi~n: dia diem, con nguai, thai gian, lo:;ti v~c

xi!! va cac . tri~u chirng theo m~u t:;ti Phv lvc 5 cua Hu6ng d~ nay b~ng ph~n mem.

4.2. Th&ng ke s& li~u - Th6ng ke s6 truang hqp tai bin n~ng sau tiem chung theo lo:;ti v~c xin. - Th6ng ke nguyen nhan tai bin ( dl,Ia tren kt lu~n cua H9i d6ng c~p tinh

va H9i d6ng c~p B9) - Th6ng ke s6 truang hqp da t6 chuc hQp H9i d6ng, thai gian di~u tra, thai

gian hQp H9i d6ng k ttr khi phat hi~n tai bin sau n~ng sau tiem chung. - Thbng ke cac s6 li~u khac khi c~n thit. 4.3. So sanh, danh gia k~t qua: So sanh kt qua v~ t1 1~ pharr trng thong

thuang, tai bin n~g sau tiem chung cua tUng lo:;ti v~c xin v&i ti 1~ u&c tinh cua cac phan tich tru&c d6 ho~c theo th6ng ke cua T6 chuc Y t th gi&i (theo Phv lvc 6 cua Hu6ng d~n nay).

5. Danh gia nguyen nhan tai bi~n n~ng sau tiem chting Banh gia nguyen nhan hi SlJ xem xet m9t each c6 h~ th6ng cac thong tin v~ truang hqp tai bin n~g sau tiem chung d xac dinh m6i lien quan gifra cac pharr trng va tiem chling d:

- Xac dinh cac v~ d~ lien quan t&i v~c xin. - Xac dinh cac v~n d~ lien quan t&i 16i cua dich V\1 tiem chling. - Lo:;ti tri'.r cac truang hqp trung hqp. 5.1. Cac tnr011g hQJ> cn danh gia nguyen nhan - Truang hqp tai bien n~ng sau tiem chling. - Chum pharr irng vu

C. Khong lien quan t6i tiem chting do trt1ng hqp ng~u nhien ho~c do nguyen nhan khac. + Cac truemg hqp khong c6 du thong tin de kt lu~n nguyen nhan dugc

coi la "khong phan lo~i dugc" va d.n phai thu th~p them thong tin d~ danh gia nguyen nhan.

- So _d6 phan lo~i nguyen nhan theo Ph1.1 l1.1c 8 cua Huang d~n nay.

KT. BQ TRUONG ~~~mJ TRUONG

6

PHV Ll}C 1: MAU BAO cAo TAl BIEN N~NG SAU TIEM CHUNG

Ma s6 truang hQP tai bin n~g sau tiem chimg ... . . ... .. . . 1. Thong tin chung

HQ va ten: .. . . . .. . . . . . . . . . .. . ... .. ... .. . . . . .. ... .... ....... Ngay thang nam sinh:-----/----/---------1 Giai: Nam 0 Nu o Dan t()c: .. .. .. .. ....... .. .. .... .. ........... .. I HQ va ten m1b6 (khi ngum dugc tiem chimg hl tre em): . . .. .. . .. . .. . .. .. .... Di~n tho~i ... .

Dia chi: Thon/cip: .. ... . .................... .. . . ....... Xa: .......... . . . ......................... . .. .. . Huy~n: .. .. . ... ... . . . . .. .. . . .. ... .. ..... ........... Tinh: .. . . .. . . .. . .. .. ... .. . . . . ... ... ...... .. . .

Ca s& tiem chimg: ... ................ ... .. ............ .. .... ....... .... .... ... .... .. .. ....... ..... ..... ...... ...... ... ... ... .. .. .

1

1

Tiem chimg m& r()ng 0 Tiem chimg dich V\1 0 T~i Tr~ y t~ 0 T~i b~nh vi~n/phong kham 0 Ngoai tr~m 0 khac 0

N gum bao cao: ...... ...... .. . .. .. . . . . ... . ..... . . . .......... ...... . . . ... .. ...... . ..... ... .. . ... .. .. . .

Dan vi: . . . . .. . .. . ... .. . . . . .. .. .. . . .. ... .. . .. . . ........... ... . . . ...... . . ... . . .. . ..... .. . .. . ..... . .. ... . .

1 Dia chi: .. .. .. . ....... . . .. ............ . ..... . ..... . ...... . .......... . ......... . . ... . .. ...... . ..... .. .. .

I Di~n tho~i & email: . .. ...... . . . .... . . . ................. . ...... .. .... . ... . ...... ........ . . ... . ... .. . I

2. Thong tin vJ tiem chimg trong Ifin mzy

Ngay, giiY Ngay, girr

Lm~i v~c xin Li~u DuiYng Vj tri Ngum tiem b~t dftu thll' miy tiem tiem tiem xay ra chiing phan ll'ng

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3. Thong tin vJ Io~i viic xin, dung moi tiem chiing trong Ifin ntiy Lo,i v~c xin, Ten v~c xin, I Nha san Don vi

s6Io H,n dung dung moi dung moi I xuit cung cip

7

4. Mo tii phiin ling

s6t cao 2:39C 0 Sung, n6ng, do t~i vi tri tiem o Ap xe t~i ch6 tiem o

B~nh nao trong vong 7 ngay 0 Nhfrng can co gi~t trong vong 3 ngay o s6c trong vong 72 gia 0

Khac 0 ghi r5 ............... . .. ... ........ ... . . ........ . . . ..... . ...... . .. .. ...... . .... . ......... . .. .

5. TiJn sir vJ binh t{it (k cii tiJn sir vJ phan ling tudng llf hay dj ling)

6. Xir tri phan ling sau tiem chung

C6 Noi xfr tri

T~inha B~nh vi~n tuy6n huy~n Y t6 tu nhan

0

0 0 0

Kh6ng

Tr~m Yt6 B~nh vi~n tuySn tinh, trung uang Khac

0

0 0 0

Hq va ten. n.guOi xfr tri . .. ......... ......... . ... . .. . .. .. .. .. .. ... . .. ....... .. .. . . .... ........... . . 7. Tinh tr{lng hiin t{li Khoi o Dich(rng 0 Tu vong o Ngay tu vong -----/----1---------Khac (ghi r5) 0 ................................................ . .. ............ . ..... . ... . ... . .

NguOi bao cao (Ky, ghi ro hQ ten)

. ....... , Ngay ...... thang ...... nam 20 . ....

8

Xac n.han. ciia cO' scr (Ky te~, dong d~u)

PHU LUC 2: PHIEU DIEU TRA TAl BIEN NANG SAU TIEM CHUNG . . .

Ma s6 tru

4.1 Tri~u chll'llg va ddu hi~u Him sang a/ Thong tin tir m~ ho~c nguOi trvc ti~p cham soc tre va hB sO' ngtrOi nha gifr (Mo ta thai gian xufit hi~n, tri~u ch(rng dftu tien cua tai bi~n, di~n bi~n tri~u ch(rng ill sau khi tiem chilng)

b/ Thong tin tir can bq y t~ va tir hB SO' b~nh an t~i CO' srr y t~ (Mota thai gian d~n ca sa y t~, tinh tr~g ban dftu, di~n bi~n tri~u ch(rng theo trinh tt,r thai gian)

4.2 K~t qua xet nghi~m c~n lam sang (mau/nu6c tieu!dich nao tuy . .. tl:li cac CO' sa y t~ nai tre duqc diSu tri)

4.3 Chin doan cu6i cimg ciia CO' srr y t~ di~u trj

4.4 Trtrimg hQ'p til vong a/Mota tinh tr~ng khi phat hi~n til vong (ttr th~, vi tri, ch~t ti~t, .. )

b/ K~t qua giam djnh phap y (thu th~p k~t qua giam dinh bkg van ban n~u c6) Ca quan giam djnh: ............... ... ... ............. ...... . ... . .. ... .. . . . .. .. .... . .. . . . ..... . K :.. , ., dinh et qua g1am . : . .. ...... . . .. ........... . ........... . ... . ... . .. . .. . . . . . . ... . ... ....... ... . . .

5. Tinh tr{lng t{li thui ililm iliBu tra 0 Dang diu tri 0 Kh6i Sau tiem chting bao Hiu: .. . .... . . . . . . 0 Tu vong Sau tiem chilng bao lau . .. . ..... .. . .. . D Di ch(rng (ghi ro) ......... .... ...... ... Sau tiem chilng bao lau ... ... .......... .. .

6. TiJn sir

a/ Ti~n sir san khoa - Tin su m~ khi mang thai: ......... ................ ... .... ..... ...... .... ...... ... .... .. .... .... ... ....... . .

- s6 tuftn thai khi sinh: .. . ... ........ Can n~ng khi sinh: .. . . . ... . .. . .. . ... . .. .. . ...... . . - Cac vftn dS sue kh6e cua tre khi sinh:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. .. .

b/ Ti~n sir b~nh t~t ciia tre tir khi sinh d~n khi dtrQ'C tiem chiing lin nay

c/ Ti~n sir tiem chiing va ph an U'llg sau cac lin tiem chiing trmrc (lol:li v~c xin, thai gian tiem, neu ro pharr l:mg sau tiem chilng n~u c6).

10

tVTi~n sfr dung thu8c ngay trU'(YC khi tiem chung lin nay (trong vong 1 tufin tru6c khi tiem chimg)

e/ TrtrO"c, trong va sau tiem chung lin nay tre an, uAng hay bU. mt; co gi bit thtrimg khong? cote, nga khong?

f/ Ti~n sfr gia dinh (di ling ho~c phfm ling v6i v~c xin ... nu c6)

7. Diu tra thvc hijn quy trinh tiem chung tf}i cu sif tiem chung

a/ Di~u ki~n bao quan vic xin, dung moi (Nh~ v~c xin tlr dau, thm gian nao, phuong ti~n nh~ v~c xin, bao quan v~c xin t~;~.i xa, c6 thit bi theo doi nhi~t d() bao quan v~c xin? Kim tra nhi~t d9 bao quan v~c xin hi~n t~;~.i, biu d6 thea doi nhi~t d() (nu bao quan v~c xin b~ng hlll;lllh)

b/ each tA chuc buBi tiem chung (S6 d6i tuQllg trong 1 bu6i tiem ? s6 can b9 tham gia tiem chimg ? C6 kham pharr lo~;~.i, tu vftn tru6c va theo doi sau tiem chimg?)

c/ Thl}'c himh tiem chung (Can b() tfiJc tip tiem chling duqc t~p huftn khong? Kim tra kin thuc v~ thvc hanh kham chi dinh va ch6ng chi dinh, bao quan v~c xin, chu~n bi v~c xin, pha h6i chinh (kY thu~t pha, thai gian su dl,lllg), su d\]llg BKT, kY thu~t tiem chling, huy v~c xin, BKT sau bu6i tiem chimg)

d/ Ghi chep va quan ly sA sach (Kim tra s6 quan ly v~c xin, s6 quan ly tiem chimg, s6 theo doi phan ling bftt thuang sau tiem chung)

e/ Tinh hinh tiem chung

S6 d6i tuQllg cling tiem trong bu6i tiem chimg CUa tlrng lo1;1i V~C xin

1 I

s6 tre tiem chl:mg cling loc:ti v~c xin: .. .. ... cling lo v~c xin:... . . . cling lQ v~c xin (nSu lQ nhiu 1iu): .... .. . v6i tru

9.2. Tinh hinh sir dt}ng lo vic xin va tai bi~n n'ng sau tiem chting tuy~n tinh, huy~n

Thong tin di~u tra Tuy~n tinh Tuy~n huy~n s6 doi tuQllg tiem chimg cimg lo~i v~c xin s6 doi tuQllg tiem chimg cimg 10 v~c xin s6 tru

PHU LUC 3: PHIEU LAY VA Gill MAu KIEM DINH VAC XIN . . .

Ca quan gui mau (Trung tam Y t dv phong tinh, thfmh ph6Iiy mau va gui):

Ly do gui mau: ......... ............... . .............. . ........................... ...... ... ......... .......... . . ., J. .A ,.. " d' :l. Gm th~yet ye nguyen nhan sau kh1 teu tra: ............................................. .. ......... .. .... .

Yeu cau kiem tra: An toan chung: .. ... ......... .......... .. .. ... ....... ... .. ..... ...... ..... .... ..... ... .... ... .. .... . A ' d~ h' ~ Kh , h' -n toan

PHU LUC 4: HUONG DAN LAY MAU BENH PIIAM DOl vm cAc . TRUONG HOP TAl BIEN NANG SAU TIEM CHUNG

. .

Tinh tr\).ng phan U'llg Miu b~nh phftm Phim ting t~i ch6 Mau Ap_xe B~nh phfun t~i 6 viem, mau Viem h~ch Mau H{)i chting thful kinh trung uang khong Dich nao tuy, mau

li~t H{)i chting thful kinh trung uang c6 li~t Pharr s6c Mau H{)i chting s6c nhim d{)c Mau, nuoi d.y mau

Tuvong Xet nghi~m tU thi, mo, C(J quan Lam t6i da cac xet nghi~m c~n lam sang c6 th~ tru6c khi tu vong

15

PHV LVC 5: BIEU MAU N~P THONG TIN VE TAl BIEN N!NG SAU TIEM CHUNG

Tu6i Lo~i vile Thai Thai

T Dia

xin, gian gian Tri~u Thai

Ho miii s6 mAy xu At

Din Kt lu~n

T ten chi Ma

sir ch(mg gian

s6 n~ay san ~l,lng hi~n chinh

bin Tinh tin (nguyen H9i Ngay

Ngay

xuat, h~n sir vac xin phan

lam tqmg xu tri hanh nhan, loai d6ng hQp bao

Nam Nil d1,1ng,nha (gia, (mg sang

dieu tai bi~ (cftp H9i cao Ghi chll

san xuAt ngay) (gier, tra ni;ing sau tinh,

d6ng tuyn

ngay) (gier, tiem B9)

tren

ngay) chung)

I.

2.

3. -- -- --

I I --

- --- -~ ~-

---- J J l - - -----1--

l l

PHV LVC 6: BANG TY LE: PHAN UNG SAU TlEM CHUNG CUA TUNG L041 V Ac XIN THEO TO CmJC Y TE THE GIOI

Bang 1: Cac phan ll'ng thong thuimg TT Lo\li vic xin Phan ll'ng t\li ebB sat (> 38C) I C:ic tri~u

(sU'llg, dau, do) I chwg tofm than 1 BCG 90-95% -2 'Viem ganB Nguai 16n ::;15% 1-6%

Tre em

TT Loai vic xin Loai phan ling Ti liYs6 li~u sfr dung 8 DTP toan te bao Kh6c dai dang

" PHV LVC 7: DANH GlA NGUYEN NHAN TAl BIEN N4NG SAU TIEM CHUNG

I. Co bing chllng ch~c ch~n v~ m6i lien quan vOi nguyen nhan khac khong? Y NUKNA

Ket qua xet nghi~m ho{lc kiem tra lam sang c6 moi lien quan v&i nguyen DO 0 0 nhan khac khong? II. Co m6i lien quan nao da d1r

PHTJ LVC s: sa no PHAN LO~I NGUYEN NilAN TAI BIEN SAU TIEM CHiJNG

I. A. Khong lien quan tai tiem chung

I C6 I. C6 bfulg ch(rng ro rang v~ m6i lien quan tm cac nguyen nhiin khac khong?

Khong II.C6 nguyen nhiin nao duoc bi8t d8n co iien quan tm v~c xin/tiem chung

l C6 II (Thm gian) Pharr (rng c6 xay ra trong khoang thm gian thfch hgp khong?

I C6 II A. Nguyen nhiin lien quan tm tiem chUng

Khong

III. A. Khong lien quan tm tiem chung

I C6 III. C6 bfulg ch(rng ro rang xac djnh khong c6 m6i lien quan vai tiem chung khong?

Khong

I IV. A. Nguyen nhiin lien quan tai tiem chung

21

KhOng

v. D~anh~gi~ c yeu to ve

h~h luqng

T C6 Phan (rng nay c6 dugc phiin lo?i khong?

Khong IVD. Khong phan lo?i dugc

C6

IV B. Chua xac djnh '

IV c. Khong lien quan t&i tiem chi'mg.