-
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
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.-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
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I I
I I
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
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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
I I !
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
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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)
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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
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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
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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
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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
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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
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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.