Quality Requirements
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.
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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 Goal（TEa%） |
TEa Source |
Recommended Critical Decision Level |
|
HGB |
B |
± 7% |
CLIA,WLSH,NYS,AAB,CAP |
1, 45g/L |
|
± 6% |
ESFEQA, Rili-BAEK 2024 |
|||
|
± 4.6% |
MIN SPANISH EQA |
|||
| ± 4% | CLIA 2025 | |||
|
± 4 g/L < 100g/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 1992,WLSH,NYS,AAB,CAP |
1, 14% |
|
±12% |
ESFEQA |
|||
|
±0.02 L/L < 0.20 L/L |
IQMH* |
|||
|
±8.5% |
MIN SPANISH EQA |
|||
| ±8.3% | RIQAS SOTA | |||
|
±9.0% |
Rili-BAEK 2024 |
|||
| ± 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 |
|
± 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 |
| ± 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 |
|
|
±7.3% |
MIN SPANISH EQA |
|||
| ±8.3% | RIQAS SOTA | |||
|
±10% |
ESFEQA |
|||
| ± 5 < 50 ± 10% > 50 |
RCPA 2024 | |||
|
±5 fL <50 fL |
IQMH* |
|||
| ±1.78% | EFLM 2019a | |||
| ±1.7% | EFLM 2024 desirable | |||
| ±2.5% | EFLM 2024 minimum | |||
|
PLT |
B |
±25% |
CLIA,CLIA 2025, WLSH,NYS,AAB,CAP |
1, 10*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 |
IQMH* |
|||
| ±10.3% | EFLM 2019b | |||
| ±10.5% | EFLM 2024 desirable | |||
| ±15.7% | EFLM 2024 minimum | |||
|
RBC |
B |
±6% |
CLIA,WLSH,NYS,AAB,CAP |
1, 3.5*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 |
ESFEQA |
|||
| ± 0.2 < 2.0 ± 10% > 2.0 |
RCPA 2024 | |||
|
±0.2 x 1012/L <2.0 x 1012/L |
IQMH* |
|||
|
± 8.0% |
Rili-BAEK 2024 |
|||
| ± 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 |
| ±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 |
ESFEQA |
|||
|
±0.5 x 109/L <5.0 x 109/L |
IQMH* |
|||
| ± 0.5 < 5.0 x 109/L ± 10% > 5.0 x 109/L |
RCPA 2024 | |||
|
±18.0% |
Rili-BAEK 2024 |
|||
| ± 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 |
|
±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% |
| ± 34% | MIN SPANISH EQA | |||
|
±8%* ≤50% (* % is unit) |
ESFEQA |
|||
|
±16mg/L ≤100mg/L |
ESFEQA |
|||
| ± 4.9% | EFLM 2024 desirable | |||
| ± 7.4% | EFLM 2024 minimum | |||
|
APTT |
P |
4.50% |
BV DES 2014 |
1, 40s |
|
15% |
CLIA,WLSH,NYS,AAB,CAP |
|||
| ± 10 < 40 sec ± 25% > 40 sec |
RCPA 2024 | |||
|
18% |
ESFEQA |
|||
| 18% | Rili-BAEK 2024 | |||
| 6.4% | EFLM 2024 minimum | |||
| 4.2% | EFLM 2024 desirable | |||
|
D-Dimer |
P |
30% |
AAB |
1, 1mg/L |
|
±0.13mg/L ≤1mg/L |
ESFEQA |
|||
|
± 0.5 FEU mg/L < 1.0 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 |
|
20% |
CLIA,CLIA 2024, WLSH,NYS,AAB,CAP |
|||
|
± 0.34 g/L ≤ 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 |
|
15% |
CLIA,CLIA 2024, WLSH,NYS,AAB,CAP |
|||
|
±12s ≤50% |
ESFEQA |
|||
|
±12s ≤0.5 |
ESFEQA |
|||
|
±2.3s ≤10s |
ESFEQA |
|||
| ±2s ≤10s ±20% ＞10s |
RCPA 2024 | |||
| ±23% | Rili-BAEK 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 |
IQMH* |
||
| ± 1.0 < 10.0 ± 10% > 10.0 |
RCPA 2024 | |||
|
Lymphocyte count |
±0.5 x 109/L < 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 |
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 |
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 |
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) |
± 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
Rili-BAEK 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. The 2024 specifications were provided graciously in an English translation by Oswald Sonntag.
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
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.