Factors Affected the Duration of Corrective Action Time of Medical Laboratory Assessment According to ISO 15189

Abstract

       This study emphasized the factors that affected the corrective action time of the medical laboratory assessment according to ISO 15189. This study was a retrospective studied of 76 laboratories during January 2010 - December 2013. That were used descriptive statistics and analytic statistics were showing the correlation of factors by multiple logistic regression and odds ratio at p-value less than 0.5. Factor affected the corrective action time include the number of accredited years, if more than 4 years will be spent more time than the other one that have no later than average four years to 3.67 times were using 245 ± 96 days and 189 ± 74 days, respectively. Total numbers of total nonconformities if the laboratory has got more than average 23 clauses will be spent more time than the other one that have no more than 23 clauses were using a 240 ± 88 days and 181 ± 85 days, respectively. The correlation level of defects, using multiple logistic regression was showed that 1) factors affected the corrective action time faster completion include the defect of 4.9 identify of nonconformity clause and 4.15 management review clause. 2) factors affected the corrective action time longer completion include the number of accredited years, the defect of 4.3 document control clause and 4.13 control of record clause. Among the factors that are related to the corrective action time were statistically significant at p-value less than 0.05. Most of affected clause are documenting and monitoring systems. It should be taken into account in development plans, activities and determine the audit criteria for monitoring the quality system in the annual quality monitoring plan. To maintain laboratory quality systems based on international standards.