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Quality Requirements

Consolidated Comparison of Hematology Performance Specifications

It's 2022, do you know how good your hematology performance needs to be? Just as with chemistry and immunoassay, there's no general consensus, agreement or standardization. But here's a consolidated summary that reveals how large the discrepancies are.

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Consolidated Comparison of Hematology Performance Specifications

Created January 22, 2018
Latest update July 24, 2022

July 24, 2022 Updated with 2024 proposed CLIA proficiency testing criteria
June 13, 2022 Updated with EFLM minimum specifications
February 17, 2022 Updated with RIQAS state of the art goals for 2022
January 24, 2022 Updated with new specifications dervied from EFLM database.
October 22, 2019 Updated with new meta-analysis specifications from EFLM
June 24th, 2019 Updated with specifications derived from the EFLM database.
March 9th, 2018 Updated with corrections to IQMH specifications and further notices on the use of their specifications.

Hematology Analyte

Sample

Type

 Total Allowable Error GoalTEa%

TEa Source

Recommended Critical Decision Level

HGB

B

±7%

CLIA,WLSH,NYS,AAB,CAP

1, 45g/L
2, 105g/L
3, 230g/L

±6%

ESFEQA, Rilibak

±5%

MIN SPANISH EQA

±4% CLIA 2024

±4 g/L < 100g/L
±5% > 100 g/L

IQMH*

± 5 < 100
± 5% > 100
RCPA 2010

±4.19%

BV DES 2014

±2.7% RIQAS SOTA
±3.8% EFLM 2022 des, 2019a, 2019b
±5.8% EFLM 2022 minimum

HCT

B

±6%

CLIA,WLSH,NYS,AAB,CAP

1, 14%
2, 33%
3, 70%

±12%

ESFEQA

±0.02 L/L < 0.20 L/L
±7% >0.20 L/L

IQMH*

±8%

MIN SPANISH EQA

±8.3% RIQAS SOTA

±9.0%

Rilibak

± 0.04 < 20
± 20% > 0.2
RCPA 2010
±4% CLIA 2024

±3.97%

BV DES 2014

±3.9% EFLM 2019a, 2022
±3.8% EFLM 2019b
±5.8% EFLM 2022 minimum

MCH

B

±2.5%

BV DES 2014

1, 27pg
2, 34pg

±5.0%

MIN SPANISH EQA

±8.3% RIQAS SOTA

±9%

ESFEQA

±1.8% EFLM 2019a,b 2022
±2.7% EFLM 2022 minimum

MCHC

B

±2.2%

BV DES 2014

1, 320g/L
2, 360g/L

±8.3% RIQAS SOTA

±7%

ESFEQA

±1.9% EFLM 2022 minimum
±1.2% EFLM 2019b
±1.3% EFLM 2019a, 2022

MCV

 

±2.42%

BV DES 2014

1, 80fL
2, 100fL

±7%

MIN SPANISH EQA

±8.3% RIQAS SOTA

±10%

ESFEQA

± 5 < 50
± 10% > 50
RCPA 2010

±5 fL <50 fL
±5% >50 fL

IQMH*

 
±1.78% EFLM 2019a  
±1.61% EFLM 2022  
±2.4% EFLM 2022 minimum  

PLT

B

±25%

CLIA,CLIA 2024, WLSH,NYS,AAB,CAP

1, 10*10^9/L
2, 50*10^9/L
3, 100*10^9/L
4, 600*10^9/L
5, 1000*10^9/L

±13.4%

BV DES 2014

±9% (impedance count)
±17.8% (optical)
RIQAS SOTA

±15%

ESFEQA

± 25 < 100
± 25% > 100
 RCPA 2010

±10 x 109/L  <20 x 109/L
±15% >20 x 109/L

IQMH*

±10.3% EFLM 2019b
±9.0% EFLM 2022
±13.5% EFLM 2022 minimum

RBC

B

±6%

CLIA,WLSH,NYS,AAB,CAP

1, 3.5*10^12/L
2, 5.5*10^12/L

±4%

CLIA 2024, MIN SPANISH EQA

±4.4%

BV DES 2014

±2.7% (impedance count)
±4.3% (optical count)
RIQAS SOTA

±0.3*1012/L ≤4*1012/L
±8% >4*1012/L

ESFEQA

± 0.2 < 2.0
± 10% > 2.0
RCPA 2010

±0.2 x 1012/L <2.0 x 1012/L
±10% > 2.0 x 1012/L

IQMH*

±8.0%

Rilibak

±3.9% EFLM 2022, 2019a
±4.0% EFLM 2019b
±5.8% EFLM 2022 minimum

WBC

B

±15%

CLIA,AAB,CAP

1, 0.5*10^9/L
2, 3*10^9/L
3, 12*10^9/L
4, 30*10^9/L

±10% CLIA 2024

±9%

MIN SPANISH EQA

±17.6%

BV DES 2014

±6.8% (impedance count)
±4.9% (optical count)
RIQAS SOTA

±0.7*109/L ≤4*109/L
±18% >4*109/L

ESFEQA

±0.5 x 109/L <5.0 x 109/L
±10% < 5.0 x 109/L

IQMH*

± 0.5 < 5.0
± 10% > 5.0
RCPA 2010

±18.0%

Rilibak

±13.8% EFLM 2022, 2019a,b
±20.7% EFLM 2022 minimum

RDW

B

±1%

ESFEQA

1, 15%

±2.56% EFLM 2019a  
±2.6% EFLM 2022  
±3.8% EFLM 2022 minimum  

MPV

B

±13%

ESFEQA

1, 8fL
2, 12.5fL

±12%

IQMH*

±9% RIQAS SOTA

±5.84%

BV DES 2014

±3.8% EFLM 2022, 2019a
±3.5% EFLM 2019b
±5.6% EFLM 2022 minimum

Antithrombin III

P

8.30%

BV DES 2014

1, 50%
2, 75%

±8%* ≤50%  (* % is unit)
±16%*
50%  (* % means ratio)

ESFEQA

±16mg/L ≤100mg/L
±16% >100mg/L

ESFEQA

APTT

P

4.50%

BV DES 2014

1, 40s
2, 90s

15%

CLIA,WLSH,NYS,AAB,CAP

± 10 < 40
± 25% > 40
RCPA 2010

18%

ESFEQA

D-Dimer

P

30%

AAB

1, 1mg/L

±0.13mg/L ≤1mg/L
±31% >1mg/L

ESFEQA

± 0.25 < 0.50
± 50% > 0.50
RCPA 2010

±0.13 FEU mg/L 1 FEU mg/L
±31% 1 FEU mg/L

ESFEQA

Fibrinogen

P

13.60%

BV DES 2014

1, 0.3g/L
2, 1.0g/L
3, 5.0g/L

20%

CLIA,CLIA 2024, WLSH,NYS,AAB,CAP

±0.34g/L ≤ 2g/L
±17% >2g/L

ESFEQA

±24%

MIN SPANISH EQA

Prothrombin Time

P

5.30%

BV DES 2014

1, 15s
2, 30s

15%

CLIA,CLIA 2024, WLSH,NYS,AAB,CAP

±12% ≤50%
±23% >50%

ESFEQA

±12 ≤0.5
±23% >0.5

ESFEQA

±2.3s ≤10s
±23% >10s

ESFEQA

Granuloctye count

 

±0.5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH*

 
± 1.0 < 10.0
± 10% > 10.0
RCPA 2010

Lymphocyte count

 

±0.5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH*

 
± 2.0 < 10.0
± 20% > 10.0
RCPA 2010

±17.6%

BV DES 2014

±15.19% EFLM 2019a
±14.8% EFLM 2019b
±15.2% EFLM 2022
±22.8% EFLM 2022 minimum

Monocyte count

 

±0.5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH*

 
± 3.0 < 10.0
± 30% > 10.0
RCPA 2010

±27.9%

BV DES 2014

±17.4% EFLM 2022
±17.3% EFLM 2019a
±16.2% EFLM 2019b
±26.2% EFLM 2022 minimum

Neutrophil count

 

±23.35%

BV DES 2014

 
± 1.0 < 10.0
± 10% > 10.0
RCPA 2010
±18.4% EFLM 2022
±18.6% EFLM 2019a
±17.5% EFLM 2019b
±27.6% EFLM 2022 minimum

Eosinophil count

 

±0.5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH*

 
± 3.0 < 10.0
± 30% > 10.0
RCPA 2010

± 37.1%

BV DES 2014

± 29.1% EFLM 2022
± 27.6% EFLM 2019a
± 28.3% EFLM 2019b
±43.7% EFLM 2022 minimum

Basophil count

 

± 0.5 x 109/L < 4.0 x 109/L
± 15% > 4.0 x 109/L

IQMH*

 
± 3.0 < 10.0
± 30% > 10.0
RCPA 2010

± 38.5%

BV DES 2014

± 17.5% EFLM 2022
± 16.9% EFLM 2019a
± 16.2% EFLM 2019b
±26.2% EFLM 2022 minimum

(automated)
Reticulocyte count

 

±33% (instrument group mean)

IQMH*

 

±35% (%)

MIN SPANISH EQA

±16.5%

BV DES 2014

 

±14.2% EFLM 2019a
±15.2% EFLM 2022, 2019b
±22.8% EFLM 2022 minimum

CLIA represents the US CLIA regulations

WLSH is Wisconsin State Lab of Hygiene.

NYS represents the now defunct New York State PT requirements

AAB is the PT program of the American Association of Bioanalyts

CAP is the PT program of the College of American Pathologists

Rilibak are the German EQA performance specifications of the Rilibak rules. Note these are the interlaboratory comparison figures. The Rilibak do state within-laboratory specifications that are smaller but these are supposed to be used for RMSD calculations, which is an alternative approach than allowable total error.

Min Spanish EQA are the minimum consensus performance specifications of multiple Spanish EQA surveys

*IQMH is the PT program of the Institute for Quality Management in Healthcare. www.IQMH.org These data are used here with permission. 2018. Copyright Institute for Quality Management in Healthcare (IQMH). All rights reserved. No part of the material protected by this copyright may be reproduced without written permission from IQMH. Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for the most current data pertaining to IQMH allowable performance limits, as IQMH is not bound to inform Westgard Web of any updates.

BV DES represents the desirable performance specifications of the Biologic Variation Database

ESfEQA is the European Society for External Quality Assessment

RCPA 2010 is the allowable limits of performance for the RCAP QAP in Haematology from 2010

EFLM 2019a, 2022: https://biologicalvariation.eu/meta_calculations These have been updated for 2022, citing the desirable specifications, as well as the newly-recommended minimum specifications.

EFLM 2019b: Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters. Clin Chem Lab Med 2019 ahead of print. Coşkun A, Braga F, Carobene A et al.

EFLM 2018: Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects. Clin Chem Lab Med. 2018 Apr 2. pii: /j/cclm.ahead-of-print/cclm-2017-1155/cclm-2017-1155.xml. doi: 10.1515/cclm-2017-1155. Coşkun A, Carobene A, Kilercik M, Serteser M, Sandberg S, Aarsand AK, Fernandez-Calle P, Jonker N, Bartlett WA, Díaz-Garzón J, Huet S, Kızıltaş C, Dalgakıran I, Ugur E, Unsal I; European Biological Variation Study of the EFLM Working Group on Biological Variation. Note that this paper only calculated desirable imprecision and desirable bias, but desirable total allowable error has been calculated from the data.

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