Factors affecting the number of nonconformities from the assessment of safety in medical laboratory according to ISO 15190:2003

Abstract

Background: Bureau of Laboratory Quality Standards established medical laboratory safety accreditation program according to ISO 15190: 2003 in Thailand since May 2013. Nonconformities (NCs) were found from 1 to 18 in each laboratory. Number of NCs may be based on variety of factors such as location of laboratory, type of organization, type and number of test items, duration of accreditation and type of NCs.

Objective: To determine the factors affecting number of NCs found by ISO 15190:2003 assessment.

Method: Multiple logistic regression was used to analyze 249 NCs of 54 medical laboratories assessed from May 2013 to December 2014.

Results: There were 4 factors affecting the number of NCs more than average. They were 1) design for safety (Adjusted Odds Ratio, ORadj=16.50, p=0.002), 2) procedures, documentation, audits and inspection (ORadj=102.20, p=0.005), 3) personnel responsibilities (ORadj=43.23, p=0.023), and 4) safe work practices (ORadj=35.37, p=0.008).

Conclusion: Improperly design of laboratory safety causes more NCs. Factors affected included no standard documented procedures, no audits and inspection for safety, personnel has no responsibilities in safety aspect, and no safe work practices. The more NCs found, the lower level of laboratory safety detected. Therefore, to reduce NCs in order to provide safety for staffs, visitors as well as environmental, these 4 factors should be focused as first priority.

Bull Chiang Mai Assoc Med Sci 2016; 49(2): 255-262. Doi: 10.14456/jams.2016.20