Analysis of nonconformities in medical laboratory accreditation and status quo of clinical laboratory quality management / 中华检验医学杂志

ABSTRACT

Objective According to the analysis on nonconformities which were found from on-site assessmentin medical laboratory ISO15189accreditationcarried on byChina National Accreditation Service for Conformity Assessment(CNAS) during years 2004to 2013,to study current status of quality management in domestic medical laboratory.Methods By means of retrospective analysis, nonconformities found in 171 times of on-site audit of 133 clinical laboratories in ISO15189 accreditation during 2004 to 2013 were collected and then classified according to requirements of ISO 15189.Results Among 1 501 nonconformities involved in 171 times of on-site audit, management and technical requirements accounted for 28.5%(428) and 71.5% ( 1073 ) respectively.The mainly clauses of nonconformity were 4.3 ( 26.2%) and 4.6 (12.6%) in management requirements and 5.3 ( 25.2%), 5.4 ( 13.1%), 5.5 ( 16.0%) and 5.6 (20.2%)in technical requirements.The mainly subclauses of technical requirements were 5.3.2, 5.3.7, 5.4.3, 5.4.9, 5.5.2, 5.5.3, 5.6.1, 5.8.3 and 5.8.10.Conclusion The weakness for the medical laboratory quality management is mainly process control(5.4, 5.5 ,5.6), laboratory equipments (5.3), document control (4.3) and external services and supplies (4.6), which werethe main directions need to be improved in current medical laboratory quality management.