NI KIM TRA

CHT LNG XT NGHIM

Mc ch, chc nng, phng thc v

nguyn tc thc hin

7 bc thc hin

6 qui lut Westgard

Phn tch biu Levey Jennings

Cc hin tong Shift v Trend

NH NGHA
Ni kim tra cht long (nternal Quality
Control QC) l h thng kim tra cht
long trong ni b mt phng xt nghim.
MUC CH
-
Pht hin nhng sai s, xc jnh loai
sai s (ss ngu nhin, ss h thng) v tnh
ss ton b (ss ton b = ss ngu nhin +
ss h thng).
-
Tm nguyn nhn gy sai s
-
xut bin php khc phc.
-
nh gi tin cy ca nhng KQ XN,
t c quyt jnh c th.
-
nh gi phng tin, my mc,
phng php v thuc th XN.
-
nh gi tay ngh KTV XN.
MUC CH
-
Cung cp tiu chun chp nhn/t chi
cho dy gi trj XN.
-
Cung cp h s lu di han v thc hin
XN.
-
Cung cp cc ti liu o tao, hun
luyn cho nhn vin (kin thc, trch nhim
v tm quan trong ca kim tra cht long).
CHC NNG
-
Da vo vic KT nhng gi trj bit
nh gi nhng gi trj cha bit (Huyt
thanh kim tra HTKT)
-
C 2 loai HTKT
+ HT khng thng s: khng bit trc
cc trj s - dng KT chnh xc
+ HT c thng s - dng KT xc thc
PHONG THC KIM TRA
-
Khi thc hin ni KTCL, phi t HTKT
mt cch ngu nhin, xen k trong cc l
huyt thanh bnh nhn v trong iu
kin thng thng ca phng XN.
-
Khng chay mt ln ring hay dnh cho
HTKT nhng iu kin ti u.
NGUYN TAC THUC HIN
CC BC TIN HNH
1. CHQN XN CN KT

Loai XN tuong di n d[nh

Glucose, cholesterol, AST, ALT
S ln KT trong ngy khng cn nhiu

Loai XN thung thay di, d n d[nh <24h

Mg++, Ca++, creatinin.
S ln KT trong ngy khng cn nhiu

Nhng XN nghi ng c vn d
Cn KT gp v nhiu ln c hng gii
quyt ngay
CC BC TIN HNH
2. CHQN HUYT THANH CN KT

HTKT phi c nhiu nng khc nhau, bao

trm dy gi trj c ngha lm sng, ti thiu phi
c 2 loai:
-
HTKT bnh thung c nng cc cht ~ HT
ngi bnh thng (trong khong trj s BT)
-
HTKT bnh I c nng cc cht ~ HT bnh
nhn (trn hay di trj s BT)

S dng cng nhiu HTKT, nh gi v chp

nhn KQ cng chnh xc.
CC BC TIN HNH
2. CHQN HT CN KT

HTKT c th mua hay t tao

Cch Im HTKT
- Hng ngy thu thp huyt thanh tha (loai b
huyt thanh c m, nhiu bilirubin, c hemoglobin
do HC v). Cho vo chai 2-3 l, 20
o
C. Mi khi
thm HT mi vo, khng lm tan HT c.
-
Khi 2-3 lt, lm tan nhit thng, trn
u
cn thn (khuy t trong 1 h, trnh si bot).
CC BC TIN HNH
2. CHQN HT CN KT
- Loc qua phu c bng thu tinh hoc li tm
3000 v/p loai cc soi huyt.
- Chia hn hop HT vo cc lo nh (5, 10, 20 ml),
y nt kn, dn nhn ghi "huyt thanh kim tra,
ngy lm.., 20
o
C; hoc ng kh, 5 ml/lo.
- Tin hnh cc KT nh gi ng nht, n
jnh, an ton (tham kho WHO, SO 15328,
15190..)
-
Khi dng: lm tan, trn u.
-
Tt nht l nn mua HTKT thng mai

Nhm khng nh mi kt qu lc khng

c qui cho l mu chun b khng ng
nht

!c th"c hi#n ng$% &$u khi chun b mu

KIM TRA NG NHT MU
(SO/EC 17043:20104.4.3)

Cch tin hnh (SO 13528:2005)

'
(% ngu nhi)n th*ng k) c+ t,nh i -i#n cho
ton b. l mu / chn 0 ch1 ti)u 2 3nh gi3
45i ch1 ti)u tin hnh 6h7n t,ch l86 li 9 l:n l%
t;ung b<nh
'
=> l, kt qu 6h7n t,ch . ng nht th?o chun
th*ng k) @i&h?; th?o 6hA6 BCh7n t,ch 6hDng
&$i m.t %u t*E F&ingl? G$ct HNIJHK
JLM Nhn 0O muP 6h7n t,ch l86 li Q'9 l:n /Ri ch1
ti)u Sluco&? cho bng kt qu &$uM
Ch7n t,ch HNIJH T3c nh . ng nht
STT GLUCOSE (!" #$ %n &'
(:n 0 (:n Q (:n 9
0 N
0
N
Q
N
9
mmolU(
Q N
0
V
N
Q
V
N
9
V
mmolU(

W W W
mmolU(
0O N
0
VV
N
Q
VV
N
9
VV
mmolU(
Bng: Kt qu phn tch dng nht mu C
1
(chi tiu GIucose)
M s
mu
Ln 1 Ln 2
Phn tch ANOVA
101561 2.62 2.65 Anova: Single actor
101562 2.66 2.65
101563 2.57 2.63 SMMA
101564 2.6 2.61 Groups Count Sum Average Variance
101565 2.64 2.6 o 1 2 5.27 2.635 0.00045
101566 2.64 2.61 o 2 2 5.31 2.655 5E-05
101567 2.66 2.64 o 3 2 5.2 2.6 0.0018
101568 2.66 2.65 o 4 2 5.21 2.605 5E-05
101569 2.65 2.66 o 5 2 5.24 2.62 0.0008
101570 2.64 2.64 o 6 2 5.25 2.625 0.00045
o 7 2 5.3 2.65 0.0002
Gi d[nh: o 8 2 5.31 2.655 5E-05
H
0
: Mu I ging nhau (dng nht)
H
1
: mu I khc nhau (khng dng
nht)
o 9 2 5.31 2.655 5E-05
o 10 2 5.28 2.64 0
ANOVA
Source of Variation SS df MS F P-value F crit
Beteen Groups 0.00778 9 0.000864 2.216524 0.115492 3.020383
Within Groups 0.0039 10 0.00039
Total 0.01168 19
= 2.216524
k-1;n-k;1-
= 3.020383 nn chp nhn H
0
, bc b H
1
Kt Iun: Mu C
1
hon ton dng nht
KIM TRA (N )NH MU
S TRUNG V (MEDIAN)
-
L gi trj gia khi tt c cc i tong quan
st oc lit k theo th t.
-
Khng bj nh hng bi cc gi trj bt thng
(outlier).
-
Nu n l l, trung vj l bnh qun 2 s ng
vj tr gia.
-
Nu n chn, trung vj l bnh qun 2 s ng
gia.
T phn v[
-M t s phn b v s phn tn ca tp d
liu.
-T phn v !"#c $%c !nh nh" sau&
+Sp xp cc s theo th t tng dn
+Ct dy s thnh 4 phn bng nhau
+T phn vj l cc gi trj tai vj tr ct
T phn vj c 3 gi trj, l t phn vj th
nht (Q1), th nh (Q2), v th ba (Q3)
Khong t phn vj (nterquartile ange -
Q)
nterquartile ange oc xc jnh nh sau:

VD: T p h p d liu: 4, 17, 7, 14, 18, 12, 3,

16, 10, 4, 4, 11
S p x p: 3, 4, 4, 4, 7, 10, 11, 12, 14, 16, 17,
18
Xc jnh t phn vj:
3, 4, 4 4, 7, 10 11, 12, 14 16, 17, 18
Quartile 1 (Q1) = (4+4)/2 = 4
Quartile 2 (Q2) = (10+11)/2 = 10.5
Quartile 3 (Q3) = (14+16)/2 = 15
Kho ng t phn v ( Interquartile Range)
IQR = Q3 - Q1 = 15 - 4 = 11

Hm exceI
- Trung bnh (Mean):
AVERAGE (number1, number2, ...)
- lch chun:
STDEV (number1, number2, ...)
- Trung vj: MEDIAN (number1,
number2, ...)
- T phn v : QUARTILE (array, quart)

STT
Glucose u !
1

"ol#L)
Glucose u !
$

"ol#L)
Kt qu kim tra d dng nht mu
1 3.80 4.07
2 3.82 4.01
3 3.77 4.05
T!ng "#nh ($% 3.80 4.04
STT
% t qu &'(n t)c' sau $ tu n * t l+c c'u n
,
1 3.84 4.12
2 3.81 4.0&
3 3.7& 4.13
T!ng "#nh ('% 3.81 4.11
($ ) '( 0.01 0.07
0.3 x no*+,
-Q. 0.08 0.12
K t ,! n Mu n jnh Mu n jnh
MU NI KIM
(QUALITY CONTROL SERUM)
CC BC TIN HNH
3. XC NH IU KIN KIM TRA
Ty mc dch

iu kin bnh thung

L iu kin thng thng thc hin tt c cc XN
hng ngy cho BN

iu kin ti uu: l iu kin oc chun bj chu

o nht (cng phng php, cng KTV, thuc th,
loai XN) nhm nh gi tin cy XN, thng thc
hin khi trin khai XN mi, thit bj mi, hay NCKH.
CC BC TIN HNH
4. THNH LAP NHNG CHUAN CHT LNG
Cc PXN phi t thit lp cc chun cht long,
gm gi trj trung bnh, lch chun (s hay SD), h
s bin thin (CV) cho vic QC v:

Khi dng dy gi trj do nh SX cung cp, PXN

cn la chon gi trj thch hop (phng php jnh
long, nhit , loai my.).

C nhiu loai HTKT, nh SX khng a y

chi tit
CC BC TIN HNH
4. THNH LAP NHNG CHUAN CHT LNG

Dy gi trj ch nh SX a ra qu rng hay

hp.

iu kin PXN khng ging vi nhng iu

kin m nh SX a ra.
CCH THIT LAP CC CHUAN CHT LNG
-
Kim tra d Ip Iai ca mt HTKT trong nhiu
ngy (t nht 20 ngy) iu kin thng thng.
-
Lp bng KT v tnh cc ai long c trng
+ Gi trj trung bnh :
+ lch chun: (S, SD)
+ H s bin thin:
+ Lp biu
Levey Jennings cho mi XN ca mi HTKT
CC BC TIN HNH
4. THNH LAP NHNG CHUAN CHT LNG
BiU LEVEY JENNINGS

oc ghi trn my hay v trn giy k ly.

Trc tung HTKT vi cc mc 1s, 2s v 3s.
Gii han 2s l gii han bo dng v 3s l gii
han hnh dng. Trc honh ghi cc ngy/thng.

Hng ngy PXN ghi KQ ca HTKT ln biu .

PXN nn c s theo di QC (tn XN, tn thit bj,

ngy thc hin, tn ngi thc hin, KQ v cc vn
xy ra).
T
T T
LCL: gii han hnh ng
LWL: gii han bo ng
LCL: gii han hnh ng
LWL: gii han bo ng
LCL: lo control limit
LWL: lo arning limit
LCL: lo control limit
LWL: lo arning limit
CL: upper control limit
WL: upper arning limit
CL: upper control limit
WL: upper arning limit
CC BC TIN HNH
5. CHAY HTKT

Tn trong iu kin bo qun HTKT.

Tn trong iu kin ha tan tr lai v

trn u huyt thanh.

Tn trong nguyn tc: Phi t HTKT

mt cch ngu nhin, xen k trong cc l
mu bnh nhn v trong iu kin thng
thng ca PXN.
CC BC TIN HNH
. NGUYN TAC CHP NHAN V LOAI B KQ
Da trn d tin cy v d dng. Cn c
trn:

KQ HTKT hin tai.

KQ HTKT nhiu ngy trc.

Biu Levey Jennings.

p dng qui lut Westgard.

Pht hin sai s ngu nhin hay h thng
Qui Iut 1
2s:
qui Iut bo
hiu, cnh bo c th c ss
ngu nhin hay h thng xy
ra. Nu 1 HTKT 2s,
ch ti HTKT khc trong cng
ln chay hay trong ln chay
trc (v c ~ 4,5 gi trj
trong 2s n 3s).
T
QUI LUAT ESTGARD: qui Iut
QUI LUAT ESTGARD: qui Iut
Qui Iut 1
3s:
pht hin ss ngu nhin hay c th
bt du xy ra ss h thng.
Bt k 1 HTKT no 3s, th ln chay XN
coi nh "ngoi pham vi kim tra. Qui lut ny ch
p dng cho mt ln chay.
T
QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

Qui Iut 2
2s:
pht hin ss h thng. Xy ra khi:
-
Trong cng 1 ln chay, c 2 HTKT 2s, v nm
mt pha gi trj trung bnh.
-
Hoc trong 2 ln chay c 2 gi trj lin tip ca cng
1HTKT 2s v nm mt pha gi trj trung bnh
T
T
QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

Qui Iut R
4s:
pht hin ss ngu nhin. Ch
p dng cho 1 ln chay.
QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

Xy ra khi trong 1 ln
chay:
-
Mt HTKT c
gi trj mean 2s
- V mt HTKT khc
c gi trj mean 2s
Qui Iut 4
1s:
pht hin ss h thng. Vi pham xy ra khi:
-
C 4 gi trj lin tip ca 1 HTKT 1s, v nm mt
pha gi trj trung bnh.
-
Hoc c 4 gi trj ca 2 HTKT khc nhau 1s, v
nm mt pha gi trj trung bnh.
T
T
QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

Qui Iut 10 : pht hin ss h thng.

Vi pham xy ra khi:
-
C 10 gi trj lin tip ca cng loai HTKT nm cng mt
pha gi trj trung bnh.
-
Hoc c 4 gi trj ca cc HTKT khc nhau nm cng mt
pha gi trj trung bnh .
T
QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

QUI LUAT ESTGARD: 1
2s
1
3s
2
2s
R
4s
4
1s
10x

TM TAT QUI LUAT ESTGARD
QUI LUAT SAI S GII THCH
1
2s
H thng
Ngu nhin
1 HTKT 2s
2
2s
H thng 2 HTKT 2s
1
3s
Ngu nhin 1 HTKT 3s
R
4s
Ngu nhin 1 HTKT c lp lai 4s
4
1s
H thng 4 HTKT lin tip 1s v nm
v mt pha gi trj trung bnh
10x
H thng 4 HTKT lin tip nm v mt pha
gi trj trung bnh
T
T
T
T
H THNG HA QUI LUAT ESTGARD
XY
Khng
Khng
N+
ZN'NIN[\I( N]^C N]_N XY =N
0
Q&
0
9&
Q
Q&
\
`&
`
0& 0O
=
Ia['I@'NIN[\I( (IbZ cd (eN N]bf
N+ N+ N+ N+ N+
Khng
Khng
Khng
Khng
Khng
Khng
Khng
Khng
. X L KHI XN B LOAI
B

Khi gi tr[ HTKT ra ngoi pham vi KT

Ly hay khng Iy KQ XN ca BN

Xem lai biu ghi KQ ca HTKT

Vit bo co nh gi lit k tt c cc hoat

ng thc hin

Xem lai ton b qu trnh thc hin XN

Phn loai sai s: ngu nhin hay h thng

Tm nguyn nhn SS: trc, trong hay sau XN

. X L KHI XN B LOAI B

Khi gi tri HTKT ra ngoi pham vi KT

Ly hay khng Iy KQ XN ca BN

Vit bo co nh gi lit k nhng vic cn

lm.

iu chnh, khc phc nhng nguyn nhn gy

SS.

Lm lai cc XN cn thit trn HTKT v mu BN

iu chnh lai thit bj, my mc (nu cn thit)

Thng bo cho lnh ao nu khng khc phc

oc s c.
HIN TNG SHIT V TREND

Hin tung SHIT (thng t ngt)

Xy ra khi gi trj ca HTKT ra ngoi gii han
1s trong 6 ngy lin tip v cng mt pha ca trj s
trung bnh.
NGUYN NHN

in cc bj v hay hng.

My bn.

Bot kh.

Thay i nhit my mc t ngt.

HIN TNG SHIT V TREND
NGUYN NHN

My tnh thi gian khng ng.

Thay i l thuc th mi.

My km nhay.

Th tch thuc th hay mu bnh khng

ng.

H thng phn phi mu c vn .

SHI*T
HIN TNG SHIT V TREND

Hin tung TREND (trot)

Xy ra khi gi trj ca HTKT tng ln hay gim
i trong 6 ngy lin tip. S thay i ny xy ra t
t.
NGUYN NHN

in cc gi.

Tch t cc cht cn trn b mt in cc.

Thuc th hng hay ln thuc th khc.

HIN TNG SHIT V TREND
NGUYN NHN

Nhim bn knh loc.

Nhit my mc thay i t t.

Ta v loai protein khng hon ton.

Nc ct khng tinh khit.

Khng kh khng trong sach.

Cuvet bj n mn do kim hay acid.

TREND
KT LUAN
1. XN lun c sai s, ni KT gip pht hin sai s
2. Ni KT l mt khu ca qu trnh XN
cn lm c quyt jnh vi KQ ca BN
3. Nguyn tc: s dng sai s k thut ton b
ca HTKT suy ra sai s ton b ca huyt
thanh BN.
KT LUAN
4. t HTKT mt cch ngu nhin, xen k trong
cc l mu bnh nhn v trong iu kin thng
thng ca PXN.
5. nh gi da trn biu Levey Jennings v
qui lut Westgard.
6. Tm nguyn nhn gy sai s .
7. iu chnh v khc phc NN gy sai s.
HAN CH CA NI KIM
1. Mang tnh ch quan, nn i hi t gic.
2. Ch yu nh gi chnh xc, cn lm ngoai
kim tra nh gi xc thc.
3. Ch nh gi oc sai s k thut ton b ca
HTKT, khng nh gi oc sai s ton b
ca huyt thanh BN, nn cn nghin cu bin
thin sinh hoc.