NI KIM TRA CHT LNG XT NGHIM

Mc ch, chc nng, phng thc v nguyn tc thc hin7 bc thc hin6 qui lut Westgard Phn tch biu Levey JenningsCc hin tng Shift v Trend

NH NGHANi kim tra cht lng (Internal Quality Control IQC) l h thng kim tra cht lng trong ni b mt phng xt nghim.

MC CHPht hin nhng sai s, xc nh loi 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 nh c th.nh gi phng tin, my mc, phng php v thuc th XN.nh gi tay ngh KTV XN.MC CH

Cung cp tiu chun chp nhn/t chi cho dy gi tr XN.Cung cp h s lu di hn v thc hin XN.Cung cp cc ti liu o to, hun luyn cho nhn vin (kin thc, trch nhim v tm quan trng ca kim tra cht lng).CHC NNG

Da vo vic KT nhng gi tr bit nh gi nhng gi tr cha bit (Huyt thanh kim tra HTKT)C 2 loi HTKT+ HT khng thng s: khng bit trc cc tr s - dng KT chnh xc+ HT c thng s - dng KT xc thc

PHNG 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 chy mt ln ring hay dnh cho HTKT nhng iu kin ti u. NGUYN TC THC HIN

CC BC TIN HNH1. CHN XN CN KTLoi XN tng i n nhGlucose, cholesterol, AST, ALTS ln KT trong ngy khng cn nhiuLoi XN thng thay i, n nh

CC BC TIN HNH2. CHN HUYT THANH CN KTHTKT phi c nhiu nng khc nhau, bao trm dy gi tr c ngha lm sng, ti thiu phi c 2 loi:HTKT bnh thng c nng cc cht ~ HT ngi bnh thng (trong khong tr s BT)HTKT bnh l c nng cc cht ~ HT bnh nhn (trn hay di tr s BT)S dng cng nhiu HTKT, nh gi v chp nhn KQ cng chnh xc.

CC BC TIN HNH2. CHN HT CN KTHTKT c th mua hay t toCch lm HTKT- Hng ngy thu thp huyt thanh tha (loi b huyt thanh c m, nhiu bilirubin, c hemoglobin do HC v). Cho vo chai 2-3 l, 20oC. Mi khi thm HT mi vo, khng lm tan HT c. Khi 2-3 lt, lm tan nhit thng, trn ucn thn (khuy t trong 1 h, trnh si bt).

CC BC TIN HNH2. CHN HT CN KT- Lc qua phu c bng thu tinh hoc li tm 3000 v/p loi cc si huyt. - Chia hn hp HT vo cc l nh (5, 10, 20 ml),y nt kn, dn nhn ghi huyt thanh kim tra, ngy lm.., 20 oC; hoc ng kh, 5 ml/l.- Tin hnh cc KT nh gi ng nht, n nh, an ton (tham kho WHO, ISO 15328, 15190.)Khi dng: lm tan, trn u. Tt nht l nn mua HTKT thng mi

Nhm khng nh mi kt qu lc khng c qui cho l mu chun b khng ng nht.c thc hin ngay sau khi chun b mu.

KIM TRA NG NHT MU(ISO/IEC 17043:20104.4.3)

Cch tin hnh (ISO 13528:2005)Ly ngu nhin thng k c tnh i din cho ton b l mu v chn 1 ch tiu nh gi. Mi ch tiu tin hnh phn tch lp li 3 ln ly trung bnh.X l kt qu phn tch ng nht theo chun thng k Fisher theo php Phn tch phng sai mt yu t (single fact ANOVA).

VD: Chn 10 mu, phn tch lp li 2-3 ln vi ch tiu Glucose cho bng kt qu sau:

Phn tch ANOVA xc nh ng nht.

STTGLUCOSE (mu 1)n vLn 1Ln 2Ln 31C1C2C3mmol/L2C1C2C3mmol/L...mmol/L10C1C2C3mmol/L

Bng: Kt qu phn tch ng nht mu C1 (ch tiu Glucose)

M s muLn 1Ln 2Phn tch ANOVA

1015612.622.65Anova: Single Factor1015622.662.651015632.572.63SUMMARY1015642.62.61GroupsCountSumAverageVariance1015652.642.6Row 125.272.6350.000451015662.642.61Row 225.312.6555E-051015672.662.64Row 325.22.60.00181015682.662.65Row 425.212.6055E-051015692.652.66Row 525.242.620.00081015702.642.64Row 625.252.6250.00045Row 725.32.650.0002Gi nh:Row 825.312.6555E-05H0: Mu l ging nhau (ng nht)H1: mu l khc nhau (khng ng nht)Row 925.312.6555E-05Row 1025.282.640

ANOVASource of VariationSSdfMSFP-valueF critBetween Groups0.0077890.0008642.2165240.1154923.020383Within Groups0.0039100.00039

Total0.0116819 F = 2.216524 < Fk-1;n-k;1-a = 3.020383 nn chp nhn H0, bc b H1Kt lun: Mu C1 hon ton ng nht

KIM TRA N NH MU

S TRUNG V (MEDIAN)L gi tr gia khi tt c cc i tng quan st c lit k theo th t. Khng b nh hng bi cc gi tr bt thng (outlier).Nu n l l, trung v l bnh qun 2 s ng v tr gia.Nu n chn, trung v 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 xc nh nh sau:Sp xp cc s theo th t tng dnCt dy s thnh 4 phn bng nhauT phn v l cc gi tr ti v tr ct

T phn v c 3 gi tr, l t phn v th nht (Q1), th nh (Q2), v th ba (Q3)

Khong t phn v (Interquartile Range - IQR) Interquartile Range c xc nh nh sau:

VD: Tp hp d liu: 4, 17, 7, 14, 18, 12, 3, 16, 10, 4, 4, 11Sp xp: 3, 4, 4, 4, 7, 10, 11, 12, 14, 16, 17, 18Xc nh t phn v: 3, 4, 4 | 4, 7, 10 | 11, 12, 14 | 16, 17, 18

Quartile 1 (Q1) = (4+4)/2 = 4Quartile 2 (Q2) = (10+11)/2 = 10.5Quartile 3 (Q3) = (14+16)/2 = 15Khong t phn v (Interquartile Range) IQR = Q3 - Q1 = 15 - 4 = 11

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

STTGlucose mu C1 (mmol/L)Glucose mu C2 (mmol/L)Kt qu kim tra ng nht mu13.804.0723.824.0133.774.05Trung bnh (A)3.804.04STTKt qu phn tch sau 2 tun k t lc chun b13.844.1223.814.0933.794.13Trung bnh (B)3.814.11|A B|0.010.070.3 x normal IQR0.080.12Kt lunMu n nhMu n nh

MU NI KIM (QUALITY CONTROL SERUM)

CC BC TIN HNH3. XC NH IU KIN KIM TRATy mc ch iu kin bnh thng L iu kin thng thng thc hin tt c cc XN hng ngy cho BN iu kin ti u: l iu kin c chun b chu o nht (cng phng php, cng KTV, thuc th, loi XN) nhm nh gi tin cy XN, thng thc hin khi trin khai XN mi, thit b mi, hay NCKH.

CC BC TIN HNH4. THNH LP NHNG CHUN CHT LNGCc PXN phi t thit lp cc chun cht lng, gm gi tr trung bnh, lch chun (s hay SD), h s bin thin (CV) cho vic IQC v: Khi dng dy gi tr do nh SX cung cp, PXN cn l chn gi tr thch hp (phng php nh lng, nhit , loi my). C nhiu loi HTKT, nh SX khng a y chi tit

CC BC TIN HNH4. THNH LP NHNG CHUN CHT LNG Dy gi tr 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 LP CC CHUN CHT LNGKim tra lp li ca mt HTKT trong nhiu ngy (t nht 20 ngy) iu kin thng thng. Lp bng KT v tnh cc i lng c trng + Gi tr trung bnh : + lch chun: (S, SD) + H s bin thin: + Lp biu Levey Jennings cho mi XN ca mi HTKT

CC BC TIN HNH4. THNH LP NHNG CHUN CHT LNGBiU LEVEY JENNINGS c ghi trn my hay v trn giy k ly. Trc tung [HTKT] vi cc mc 1s, 2s v 3s. Gii hn 2s l gii hn bo ng v 3s l gii hn hnh ng. Trc honh ghi cc ngy/thng. Hng ngy PXN ghi KQ ca HTKT ln biu . PXN nn c s theo di IQC (tn XN, tn thit b, ngy thc hin, tn ngi thc hin, KQ v cc vn xy ra).

LCL: gii hn hnh ng LWL: gii hn bo ngLCL: low control limitLWL: low warning limitUCL: upper control limitUWL: upper warning limit

CC BC TIN HNH5. CHY HTKTTn trng iu kin bo qun HTKT.Tn trng iu kin ha tan tr li v trn u huyt thanh.Tn trng 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 HNH6. NGUYN TC CHP NHN V LOI B KQDa trn tin cy v ng. Cn c trn:KQ HTKT hin ti. KQ HTKT nhiu ngy trc. Biu Levey Jennings. p dng qui lut Westgard.

Pht hin sai s ngu nhin hay h thngQui lut 12s: qui lut 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 chy hay trong ln chy trc (v c ~ 4,5% gi tr trong 2s n 3s).QUI LUT WESTGARD: 6 qui lut

Qui lut 13s: pht hin ss ngu nhin hay c th bt u xy ra ss h thng. Bt k 1 HTKT no > 3s, th ln chy XN coi nh ngoi phm vi kim tra. Qui lut ny ch p dng cho mt ln chy.QUI LUT WESTGARD: 12s ;13s ;22s ;R4s ;41s ;10x

Qui lut 22s: pht hin ss h thng. Xy ra khi:Trong cng 1 ln chy, c 2 HTKT > 2s, v nm mt pha gi tr trung bnh. Hoc trong 2 ln chy c 2 gi tr lin tip ca cng 1HTKT > 2s v nm mt pha gi tr trung bnh

QUI LUT WESTGARD: 12s ;13s ;22s ;R4s ;41s ;10x

Qui lut R4s: pht hin ss ngu nhin. Ch p dng cho 1 ln chy.QUI LUT WESTGARD: 12s ;13s ;22s ;R4s ;41s ;10x Xy ra khi trong 1 ln chy: Mt HTKT c gi tr > mean + 2s - V mt HTKT khc c gi tr > mean - 2s

Qui lut 41s: pht hin ss h thng. Vi phm xy ra khi:C 4 gi tr lin tip ca 1 HTKT > 1s, v nm mt pha gi tr trung bnh. Hoc c 4 gi tr ca 2 HTKT khc nhau > 1s, v nm mt pha gi tr trung bnh. QUI LUT WESTGARD: 12s ;13s ;22s ;R4s ;41s ;10x

Qui lut 10 : pht hin ss h thng. Vi phm xy ra khi: C 10 gi tr lin tip ca cng loi HTKT nm cng mt pha gi tr trung bnh. Hoc c 4 gi tr ca cc HTKT khc nhau nm cng mt pha gi tr trung bnh .QUI LUT WESTGARD: 12s ;13s ;22s ;R4s ;41s ;10x

TM TT QUI LUT WESTGARD

QUI LUTSAI SGII THCH12sH thngNgu nhin1 HTKT > 2s22sH thng2 HTKT > 2s13sNgu nhin1 HTKT > 3sR4sNgu nhin1 HTKT c lp li > 4s41sH thng4 HTKT lin tip > 1s v nm v mt pha gi tr trung bnh10xH thng4 HTKT lin tip nm v mt pha gi tr trung bnh

H THNG HA QUI LUT WESTGARDKQKhngCIN-CONTROL CHP NHN KQ XN12s13s22sR4s41s10XOUT-OF-CONTROL LOI B LN CHYCCCCCKhngKhngKhngKhng

7. X L KHI XN B LOI B Khi gi tr HTKT ra ngoi phm vi KTLy hay khng ly KQ XN ca BN ??? Xem li biu ghi KQ ca HTKT Vit bo co nh gi lit k tt c cc hot ng thc hin Xem li ton b qu trnh thc hin XN Phn loi sai s: ngu nhin hay h thngTm nguyn nhn SS: trc, trong hay sau XN

7. X L KHI XN B LOI B Khi gi tri HTKT ra ngoi phm vi KTLy hay khng ly 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 li cc XN cn thit trn HTKT v mu BN iu chnh li thit b, my mc (nu cn thit) Thng bo cho lnh o nu khng khc phc c s c.

HIN TNG SHIFT V TREND Hin tng SHIFT (thng t ngt)Xy ra khi gi tr ca HTKT ra ngoi gii hn 1s trong 6 ngy lin tip v cng mt pha ca tr s trung bnh.NGUYN NHN in cc b v hay hng. My bn. Bt kh. Thay i nhit my mc t ngt.

HIN TNG SHIFT V TRENDNGUYN NHN My tnh thi gian khng ng. Thay i l thuc th mi. My km nhy.Th tch thuc th hay mu bnh khng ng.H thng phn phi mu c vn .

SHIFT

HIN TNG SHIFT V TREND Hin tng TREND (trt)Xy ra khi gi tr 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 SHIFT V TRENDNGUYN NHN Nhim bn knh lc. Nhit my mc thay i t t. Ta v loi protein khng hon ton. Nc ct khng tinh khit. Khng kh khng trong sch. Cuvet b n mn do kim hay acid.

TREND

KT LUN1. XN lun c sai s, ni KT gip pht hin sai s2. Ni KT l mt khu ca qu trnh XNcn lm c quyt nh vi KQ ca BN3. Nguyn tc: s dng sai s k thut ton b ca HTKT suy ra sai s ton b ca huyt thanh BN.

KT LUN4. 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.

HN CH CA NI KIMMang tnh ch quan, nn i hi t gic.Ch yu nh gi chnh xc, cn lm ngoi kim tra nh gi xc thc.Ch nh gi c sai s k thut ton b ca HTKT, khng nh gi c sai s ton b ca huyt thanh BN, nn cn nghin cu bin thin sinh hc.