Tools, Technologies and Training for Healthcare Laboratories

Quality Requirements

Minimum analytical quality requirements

What's the absolute minimum for quality? In 2012, four Spanish EQA providers formed a working group to promote the use of common minimum quality specifications for clinical tests. 

Minimum analytical quality specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers

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

Reprinted with permission of the authors

The authors looked at EQA results from 2005 to 2010, six cycles from 4 societies. Using these results, they retrospectively adjusted the quality requirements to determine the size required to allow 95% of laboratories to meet the EQA challenge.

The authors note: "The proposed specifications stand for the minimum level of quality to be attained for laboratories, to assure harmonized service performance. They have nothing to do with satisfying clinical requirements, which are the final level of quality to be reached, and that is strongly recommended in our organizations by means of documents, courses, symposiums and all types of educational activities."

In other words, laboratories should not use these quality requirements as a basis for designing internal QC. They should only be used to determine whether a laboratory is meeting the bare minimum level of performance.

Analytes are shown in alphabetic order. Values are expressed as percentages from the mean target value. MQS, minimum quality specification

Analyte (abbreviation) Minimum
Quality Specification
α-Amylase, total (Amy) 35
α-Phetoprotein (AFP) 20
Albumin (Alb) 14
Alanine aminotransferase (ALT) 23
Alkaline phosphatase (ALP) 31
Aspartate aminotransferase (AST) 21
Bilirubin (Bil) 24
Calcium (Cal) 11
Carcinoembrionary antigen (CEA) 16
Chloride (Chl) 9
Cholesterol (Cho) 11
Cortisol (Cor) 28
Creatine kinase (CK) 24
Creatinine (Cre) 20
Digoxin (Dig) 20
Erythrocyte (Ery) 4
Estradiol (Est) 26
Ferritine (Fer) 21
Fibrinogen (Fib) 24
Folitropin (FSH) 14
Free thyroxine (FT 4 ) 16
γ-Glutamyl transferase (GGT) 22
Glucose (Glu) 11
HDL cholesterol (HDLC) 33
Hematocrit (Htc) 8
Hemoglobin (Hem) 5
Immunogobulin A (IgA) 21
Immunogloblin G (IgG) 16
Immunogloblin M (IgM) 28
International normalized ratio (INR) 24
Iron (Fe) 24
Lactate dehydrogenase (LDH) 26
Leukocyte (Leu) 9
Lithium (Li) 18
Lutropin (LH) 17
Mean corpuscular hemoglobin (MCH) 5
Mean corpuscular Hb conc. (MCHC) 8
Mean corpuscular volume (MCV) 7
Partial thromboplastin time (PTTA), ratio 15
Partial thromboplastin time (PTTA), s 27
Phenobarbital (Phe) 15
Phenytoin (Pht) 13
Phosphate (Pho) 17
Platelet (Pla) 16
Potassium (K) 8
Progesteron (Prg) 26
Prolactin (Prl) 22
Protein (Pro) 12
Prothrombin time (PT % ), % 29
Prothrombin time (PTr), ratio 17
Sodium (Na) 5
Theophilline (The) 12
Testosterone (Tes) 23
Thriiodothyronine (T3) 24
Thyrothropin (TSH) 15
Total prostatic specific antigen (PSA) 17
Total thyroxine (TT4) 24
Triglyceride (Tri) 18
Urate (Ura) 17
Urea (Ure) 19

Thanks to the authors for the permission to reprint this data.


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