Tools, Technologies and Training for Healthcare Laboratories

Quality Requirements

Spanish Minimum Consensus Performance Specifications

What's the absolute minimum for quality? In 2015, four Spanish EQA providers updated their earlier consensus goals to expand a common set of minimum performance specifications for tests. 

Consensus Minimum analytical performance specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers (2015)

Quality analytical specifications obtained by consensus through intercomparison programs AEFA/AEBM, SEQC and SEHH. [Asociación Espanola de Farmacéuticos Analistas (AEFA), Asociación Espanola de Biopatología Médica (AEBM), Espana Sociedad Espanola de Hematología y Hemoterapia (SEHH), Sociedad Espanola de Bioquímica Clínica y Patología Molecular (SEQC)] http://dx.doi.org/10.1016/j.cali.2015.06.006 Revista de Calidad Asistencial, Volume 30, Issue 6, Pages 341-343  R. Blázquez, E. Prada, C. Ricós, G. Gutiérrez-Bassini, J. Morancho, Á. Salas, J.M. Jou, F. Ramón

This recent publication is an expansion of a 2012 report:

Carmen Ricos, Francisco Ramon, Angel Salas, Antonio Buno, Rafael Calafell, Jorge Morancho, Gabriella Gutierrez-Bassini and Josep M Jou, Interdisciplinary Expert Committee for Quality Specifications in the Clinical Laboratory, Clin Chem Lab Med 2012;50(3):485-461. The previous article had been printed with permission of the authors

The table below does not include all the analytes listed in the full article above. This is just an excerpt:

Sample
type
Analyte
Consensus Minimum
Quality Specification
CLIA Ricos Desirable
Serum Amylase 35  30 14.6
Urine Amylase 35   88.82 (pancreatic)
Serum α-fetoprotein (AFP) 20 ± 3 SD  21.9
Serum Alkaline phosphatase (ALP) 31 30 12.04
Serum Albumin 14 10  4.07
Urine Albumin 38    46.1
Serum Alanine aminotransferase (ALT) 23 20  27.48
Serum Aspartate aminotransferase (AST) 21  20  16.69
Serum Bilirubin (total) 24 ± 0.4 mg/dL or ± 20% (greater)   26.94
Serum Calcium 11 ± 1.0 mg/dL  2.55
Urine Calcium 30   34.1
Serum Carcinoembryonic antigen (CEA) 16    24.7
Serum Chloride 9 5 1.5
Urine Chloride 12    
Serum Cholesterol 11  10 9.01
Serum HDL-cholesterol 33  30 11.63
Serum Cortisol 28 25 22.8
Serum Creatinine kinase (CK) 24 30 30.3
Serum Creatinine 20 ± 0.3 mg/dL or ± 15% (greater)  8.87
Urine Creatinine 15    28.4
Serum Digoxin 20 ± 20% or ± 0.2 ng/mL (greater)   
Blood Erythrocytes 4  6 4.4
Serum Estradiol 26    26.86
Serum Ferritin 21   16.9
Plasma Fibrinogen 24 20 13.6
Serum Follitropin (FSH) 14   21.19
Serum γ-Glutamyl transferase (GGT) 22   22.11
Serum Glucose 11 ± 6 mg/dL or ± 10% (greater)   6.96
Urine Glucose 12    
Blood Hematocrit 8 6 3.97
Blood Hemoglobin 5  7  4.19
Blood Hemoglobin A1c 12   3
Serum Immunogobulin A (IgA) 21 ± 3 SD  13.5
Serum  Immunogloblin G (IgG) 16  25  8.0
Serum Immunogloblin M (IgM) 28  ± 3 SD  16.8
Serum Iron 24 20 30.7
Serum Lactate dehydrogenase (LDH) 26 20  11.4
Blood Leukocytes 9 15  15.49
Serum Lithium 18 ± 0.3 mmol/L or ± 20% (greater)   
Serum Lutropin (LH) 17   27.92
Blood Mean corpuscular hemoglobin (MCH) 5   2.5
Blood Mean corpuscular volume (MCV) 7   2.42
Plasma Partial thromboplastin time (PTTA), ratio 15    
Plasma Partial thromboplastin time (PTTA), s 27 15  
Serum Phenobarbital 15 20  
Serum Phenytoin 13  25  
Serum Phosphate 17    10.11
Urine Phosphate 16    22.1
Blood Platelets 16 25 13.4
Serum Potassium 8 ± 0.5 mmol/L   5.61
Urine Potassium 12   28.4
Serum Progesterone 26    
Serum Prolactin 22   29.4
Serum Protein 12 10 3.63
Urine Protein 34   40.0
Plasma Prothrombin time (PT % ), % 29   5.3
Plasma Prothrombin time (PTr), ratio 17    
Blood Reticulocytes (%) 35    
Blood Reticulocytes (x 109/l) 39   16.8
Serum Sodium 5 ± 4 mmol/L  0.73
Urine Sodium 10   32.0
Serum Testosterone 23   13.61
serum Thriiodothyronine (T3) 24 ± 3 SD  12.94
Serum Thyrotropin (TSH) 15 ± 3 SD  23.7
Serum Total prostatic specific antigen (PSA) 17   33.6
Serum Throxine,  Free (FT4) 16 ± 3 SD  8.0
Serum Total thyroxine (TT4) 24 ± 3 SD   7.0
Serum Triglycerides 18 25  25.99
Serum Urate 17 17 11.97
Urine Urate 15   19.39
Serum Urea 19 ± 2 mg/dL or ± 9% (greater)  15.55
Urine Urea 19   22.1

One of the things to notice is that the CLIA goals, when they are available, although they are often criticized as being too old or too wide, are quite similar to these new consensus goals, while the differences between the consensus goals and the desirable TEa specifications are frequently quite significant.

Further, there are no differences in the analyte specifications in 2012 and the updates to those same analytes in 2015. So there is a consistent performance in the field.