Tools, Technologies and Training for Healthcare Laboratories

Consolidated Comparison of Hematology and Coagulation 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.

GAMECHANGE: AN ON-DEMAND WEBINAR ON CLIA
View the ON-DEMAND webinar GAMECHANGE: How CLIA 2024 impacts immunoassys and hematology

Consolidated Comparison of Hematology and Coagulation Performance Specifications

Created January 22, 2018
Latest update February 18, 2024

February 18, 2024 Updated with latest EFLM specifications, which are now called goals
March 23, 2023 Updated with EFLM Coagulation performance specifications
July 24, 2022 Updated with 2024 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

± 4.6%

MIN SPANISH EQA

± 4% CLIA 2024

± 4 g/L < 100g/L
± 5% > 100 g/L

IQMH*

± 5 < 100
± 5% > 100
RCPA 2024

± 4.19%

BV DES 2014

± 2.7% RIQAS SOTA
± 3.8% EFLM 2019a, 2019b
± 3.9% EFLM 2024 desirable
± 5.9% EFLM 2024 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*

±8.5%

MIN SPANISH EQA

±8.3% RIQAS SOTA

±9.0%

Rilibak

± 0.04 < 0.20
± 20% > 0.2
RCPA 2024
±4% CLIA 2024

±3.97%

BV DES 2014

±3.9% EFLM 2019a, 2024 desirable
±3.8% EFLM 2019b
±5.8% EFLM 2024 minimum

MCH

B

± 2.5%

BV DES 2014

1, 27pg
2, 34pg

± 4.9%

MIN SPANISH EQA

± 8.3% RIQAS SOTA

± 9%

ESFEQA

± 2 < 20 pg
± 10% > 20 pg
RCPA 2024
± 1.8% EFLM 2019a,b 2022
± 1.7% EFLM 2024 desirable
± 2.6% EFLM 2024 minimum

MCHC

B

± 2.2%

BV DES 2014

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

± 8.3% RIQAS SOTA
± 8.2% MIN SPANISH EQA

± 7%

ESFEQA

± 30 < 300 g/L
± 10% > 300 u/L
RCPA 2024
± 1.9% EFLM 2024 minimum
± 1.2% EFLM 2019b
± 1.3% EFLM 2019a, 2024 desirable

MCV

 

±2.42%

BV DES 2014

1, 80fL
2, 100fL

±7.3%

MIN SPANISH EQA

±8.3% RIQAS SOTA

±10%

ESFEQA

± 5 < 50
± 10% > 50
RCPA 2024

±5 fL <50 fL
±5% >50 fL

IQMH*

 
±1.78% EFLM 2019a  
±1.7% EFLM 2024 desirable  
±2.5% EFLM 2024 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

± 16% MIN SPANISH EQA
± 25 < 100 x 109/L
± 25% > 100 x 109/L
 RCPA 2024

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

IQMH*

±10.3% EFLM 2019b
±9.0% EFLM 2024 desirable
±13.5% EFLM 2024 minimum

RBC

B

±6%

CLIA,WLSH,NYS,AAB,CAP

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

±4.1%

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 2024

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

IQMH*

± 8.0%

Rilibak

± 3.9% EFLM 2019a
± 4.0% EFLM 2019b
± 4.2% EFLM 2024 desirable
± 6.3% EFLM 2024 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

±10%

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 x 109/L
± 10% > 5.0 x 109/L
RCPA 2024

±18.0%

Rilibak

± 13.8% EFLM 2019a,b
± 14.3% EFLM 2024 desirable
± 21.4% EFLM 2024 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

± 2 < 10 fL
± 20% > 10 fL
RCPA 2024
± 3.8% EFLM 2019a
± 3.5% EFLM 2019b
± 3.8% EFLM 2024 desirable
± 5.6% EFLM 2024 minimum

Antithrombin III

P

± 8.30%

BV DES 2014

1, 50%
2, 75%

± 34% MIN SPANISH EQA

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

ESFEQA

±16mg/L ≤100mg/L
±16% >100mg/L

ESFEQA

± 4.9% EFLM 2024 desirable
± 7.4% EFLM 2024 minimum

APTT

P

4.50%

BV DES 2014

1, 40s
2, 90s

15%

CLIA,WLSH,NYS,AAB,CAP

± 10 < 40 sec
± 25% > 40 sec
RCPA 2024

18%

ESFEQA

18% Rilibak
6.4% EFLM 2024 minimum
4.2% EFLM 2024 desirable

D-Dimer

P

30%

AAB

1, 1mg/L

±0.13mg/L ≤1mg/L
±31% >1mg/L

ESFEQA

± 0.5 FEU mg/L < 1.0 FEU mg/L;
±31% >1 FEU mg/L

ESFEQA

± 0.31 FEU mg/L up to 1 FEU mg/L;
± 50% 1 FEU mg/L
RCPA 2024
± 31.7% EFLM 2024 desirable
± 47.5% EFLM 2024 minimum

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

± 0.34 g/L ≤ 2g/L
± 17% >2g/L

ESFEQA

± 0.20 g/L ≤ 1.0 g/L
± 25% >1.0 g/L
RCPA 2024

± 21%

MIN SPANISH EQA

± 13.4% EFLM 2024 desirable
± 20.1% EFLM 2024 minimum

Prothrombin Time

P

5.30%

BV DES 2014

1, 15s
2, 30s

15%

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

±12s ≤50%
±23% >50%

ESFEQA

±12s ≤0.5
±23% >0.5

ESFEQA

±2.3s ≤10s
±23% >10s

ESFEQA

±2s ≤10s
±20% >10s
RCPA 2024
±3.6% EFLM 2024 desirable
±5.4% EFLM 2024 minimum

Prothrombin Time INR

 

P

 

± 3.4% EFLM 2024 desirable

 

± 21% MIN SPANISH EQA
± 5.1% EFLM 2024 minimum
Factor II (F2)   ± 7.6% EFLM 2024 desirable  
± 11.4% EFLM 2024 minimum
± 3 ≤ 10 IU/dL
± 30% >10 IU/dL
RCPA 2024
Factor V (F5)   ± 9.2% EFLM 2024 desirable  
± 13.8% EFLM 2024 minimum
± 37% MIN SPANISH EQA
± 3 ≤ 10 IU/dL
± 30% >10 IU/dL
RCPA 2024
Factor VII (F7) activity
 
   ± 11.7% EFLM 2024 desirable   
± 17.5% EFLM 2024 minimum
± 3 ≤ 10 IU/dL
± 30% >10 IU/dL
RCPA 2024
 Factor VIII (F8) activity
 
   ± 13.2% EFLM 2024 desirable   
± 19.8%  EFLM 2024 minimum 
± 3 ≤ 10 IU/dL
± 30% >10 IU/dL
RCPA 2024
Factor IX (F9)      ± 10.1% EFLM 2024 desirable   
± 15.2% EFLM 2024 minimum 
± 3 ≤ 10 IU/dL
± 30% >10 IU/dL
RCPA 2024
Factor X (F10)   ± 8.1% EFLM 2024 desirable  
± 12.1% EFLM 2024 minimum
± 3 ≤ 10 IU/dL
± 30% >10 IU/dL
RCPA 2024
Factor XI (F11)   ± 7.4% EFLM 2024 desirable  
± 11.0% EFLM 2024 minimum
± 3 ≤ 10 IU/dL
± 30% >10 IU/dL
RCPA 2024
Factor XII (F12)   ± 9.2% EFLM 2024 desirable  
± 13.8% EFLM 2024 minimum
± 3 ≤ 10 IU/dL
± 30% >10 IU/dL
RCPA 2024

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 2024

Lymphocyte count

 

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

IQMH*

 
± 19% MIN SPANISH EQA
± 2.0 < 10.0
± 20% > 10.0
RCPA 2024

±17.6%

BV DES 2014

±15.19% EFLM 2019a
±14.8% EFLM 2019b
±15.1% EFLM 2024 desirable
±22.7% EFLM 2024 minimum

Monocyte count

 

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

IQMH*

 
± 73% MIN SPANISH EQA
± 3.0 < 10.0
± 30% > 10.0
RCPA 2024

± 27.9%

BV DES 2014

± 17.3% EFLM 2019a
± 16.2% EFLM 2019b
±17.4% EFLM 2024 desirable
± 26.2% EFLM 2024 minimum

Neutrophil count

 

± 23.35%

BV DES 2014

 
± 8.4% MIN SPANISH EQA
± 1.0 < 10.0
± 10% > 10.0
RCPA 2024
± 18.4% EFLM 2022
± 18.6% EFLM 2019a
± 17.5% EFLM 2019b
±18.7% EFLM 2024 desirable
± 28.0% EFLM 2024 minimum

Eosinophil count

 

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

IQMH*

 
± 29% MIN SPANISH EQA
± 3.0 < 10.0
± 30% > 10.0
RCPA 2024

± 37.1%

BV DES 2014

± 27.6% EFLM 2019a
± 28.3% EFLM 2019b
± 42.6% EFLM 2024 minimum
± 28.4% EFLM 2024 desirable

Basophil count

 

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

IQMH*

 
± 100% MIN SPANISH EQA
± 3.0 < 10.0
± 30% > 10.0
RCPA 2024

± 38.5%

BV DES 2014

± 16.9% EFLM 2019a
± 16.2% EFLM 2019b
± 17.9% EFLM 2024 desirable
± 26.8% EFLM 2024 minimum

(automated)
Reticulocyte count

 

± 33% (instrument group mean)

IQMH*

 
± 32%(%); ± 33%( x 109/L) MIN SPANISH EQA

± 16.5%

BV DES 2014

± 14.2% EFLM 2019a
± 15.2% EFLM 2024 desirable, 2019b
± 22.8% EFLM 2024 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. Minimum analytical quality consensus specifications in Spain. Comparison with previous, mandatory and biological variability values. Enrique Prada de Medio, Angel Mlonia Borras, Jose Alcaraz Quiles et al. Rev Med Lab 2020;1(3):93-107. 

*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.