y& ? i © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò ·...

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Page 1: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

2/66

2017 3

1968 43 2 20

11,611

249,899

64 11 532

8,348 3,453 4,8952017 6

SYStematical MEdics X

3/66

Page 2: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

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&

63.8%

6.4%

4.6%

16.4%

1.8%7.0%

2,4982017 3

63.8%

6.4%

3.2%

1.4%

16.4%

1.8%

7.0%

2017 3

6/66

ISO 17511:2003

7/66

SIa) SI

b) SI

* ISO 17511:2003

ISO 175115

Page 3: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

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SIa) SI

b) SI A1c CRM522HDL-

WHO

* ISO 17511:2003

400 7005

9/66

Reference method for the enumeration of erythrocytes and leucocytes,Clin.lab.Haemat 1994;16,131-138

Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol2001;115:460-464

NCCLS. Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard-Third Edition. NCCLS document H15-A3 (ISBN 1-56238-425-2). NCCLS, 940 West Valley Road, Suite 14000, Wayne, Pennsylvania 19087-1898, USA 2000.

NCCLS. Procedure for Determining Packed Cell Volume by the MicrohematocritMethod; Approved Standard-Third Edition. NCCLS document H7-A3 (ISBN 1-56238-413-9). NCCLS, 940 West Valley Road, Suite 14000, Wayne, Pennsylvania 19087-1898, USA 2000.

NCCLS National Committee for Clinical Laboratory StandardsCLSI Clinical and Laboratory Standards Institute

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* Reference method for the enumeration of erythrocytes and leucocytes. INTERNATIONAL COUNCIL FOR STANDARDIZATION IN HAEMATOLOGY;PREPARED BY THE EXPERT PANEL ON CYTOMETRY Clin. lab. Haemat. 1994; 16: 131-138

μ μ

μ μ μ μ

( )(

( )

11/66

Page 4: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

12/66

14/66 15/66

Page 5: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

16/66

ICSH

16 17/66

1 mL

000000 386520Count window

18/66 19/66

Page 6: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

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RBC WBC PLTHGB HCT

1. ICSH,CLSI

22/66 26/66

RBC WBC PLT HGB HCT

(k=2)0.9% 1.2% 2.6% 1.8% 1.2%

(k=2)1.5% 3.6% 4.3% 2.2% 1.7%

Page 7: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

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JCCLS

4.3 - 5.6106/μL

3.8 - 5.03.3 - 8.6 103/μL150 - 350 103/μL

13.5 - 17.0g/dL

11.5 - 15.040 - 51

%35 - 45

4.4

6.3340

13.6

42

0.066

0.2315 ↑

0.30 ↓

0.72

29/66 30/66

Page 8: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

31/66 32/6632

(Quality Control)

33/66

33

( )

(product)

(

(((

(

Quality Control /

34/66

( )

34, P2

Page 9: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

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Internal Quality Control( )

External Quality Assessment

36/66

37/6637 38/66

( )

x-R

x-Rs, x-Rs-R

Westgard

Twin plot

Cm

Page 10: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

39/66 40/6640

41/66 42/66

Page 11: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

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( ( ))EQA

45/66

External Quality Assessment Proficiency Testing

46/66

College of American Pathologists (CAP)

SNCS/eQAPi

( )

Page 12: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

47/66 48/66

ISO/IEC17043 SNCS/eQAPi

54/66

( )

( )ISO17043

ISO/IEC 17043

SNCS/eQAPi ISO15189

SNCS/eQAPiISO/IEC 17043

2014/2

Page 13: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464

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ISO/IEC 17043

6/21

JAB(

SNCS/eQAPi

ISO/IEC 17043

ISO/IEC 17043(

56/66

Web

QC

SNCS1999

SNCS

57/66

eQAPi 1975

eQAPi

58/66

1975 1 2001 9ISQC(International Symposium QC)

1999 QC/ 20032004 eQAPi 2006 SNCS/eQAPi

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8,200

55 CRP

96 CBC( )DIFF( ), RET

10 APTT, PT,FIBFDP,D

4 HBA1C

51 HBs , HCV , HIV

32 CRP, IgG,

( ) 18 ( , , )19 mRNA

- -

2017 9

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eQAPiexternal

EQAinternal

IQC

62/66

SDI PI

A

B

C

D

4Inter Lab SD

4Intra Lab SD

PI

INTRA-SDSD

SDI

INTER-SD

65/66

Page 15: Y& ? I © « Ó µ ¡ « b +0[ > | g + 0è9 « î Ò · leucocytes,Clin.lab.Haemat1994;16,131-138 / ` È Platelet Counting by the RBC/Platelet Ratio Method, Am J Clin Pathol 2001;115:460-464