Implementing the Stockholm Conference hierarchy of objective quality criteria in a routine laboratory.
Clin Chem Lab Med
; 45(4): 549-52, 2007.
Article
en En
| MEDLINE
| ID: mdl-17439337
ABSTRACT
BACKGROUND:
Analytical performance of clinical laboratory testing should be evaluated against objective quality specifications. The Stockholm Conference consensus recommendation states that from a hierarchy of quality models, the highest-ranking model should be used. This study reports the performance of a routine clinical laboratory using these quality recommendations. Quality standards recommended for use in manufacturers' package inserts are also compared against the objective criteria.METHODS:
Imprecision of 22 analytes was monitored by analyzing three levels of commercial quality control (QC) material daily over a 6-month period. The performance for each analyte was evaluated against defined quality specifications based on biological variation and the National Cholesterol Education Panel (NCEP) criteria.RESULTS:
Overall, objective quality specifications were met by the laboratory for 18/22 (82%) analytes. The performance for analytes not meeting the criteria was assessed against quality targets based on a model lower in the hierarchy, i.e., interlaboratory imprecision data derived from an accredited EQA program. All analytes met these quality targets. When quality targets set by the manufacturer were applied to biological variation and NCEP criteria, results for only 8/22 (36%) analytes met the targets.CONCLUSIONS:
Objective quality specifications can be consistently achieved in a routine laboratory. The hierarchy model of the Stockholm Conference should be promoted for global adoption.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Control de Calidad
/
Laboratorios
Tipo de estudio:
Guideline
/
Prognostic_studies
Idioma:
En
Revista:
Clin Chem Lab Med
Asunto de la revista:
QUIMICA CLINICA
/
TECNICAS E PROCEDIMENTOS DE LABORATORIO
Año:
2007
Tipo del documento:
Article
País de afiliación:
Emiratos Árabes Unidos