Impact of developing and implementing nonconformance management system at clinical biochemistry laboratory section of tertiary care hospital run by Government of Gujarat, India

Abstract

In the era of evidence based medicine, laboratories are in implied need of providing quality services to their stakeholders. Development and implementation of NMS is the most important for laboratory preparing for accreditation. The aim of the study is to supplement the knowledge and to provide guidance about development of NMS in accordance with the accreditation requirements. The study was conducted at clinical biochemistry section of NCHSLS, Gujarat, India. Total of 85 NCs retrieved from the nonconformance record for the period of Oct 2011 to Sep 2013. They were analyzed for sources. Analysis was done to know whether they belong to management or technical requirements. Frequency and percentage-wise analysis of NCs related to various procedures of total testing process was also done and RCA for some of the NCs were done using 5 why’s or Fish bone technique.Majority of NCs are related to IQC (60%), External audit (14%) and EQAS (12%).Major NCs occurred in analytical and post analytical procedures and were related to the technical requirements (87%) pertaining to laboratory equipment (35%) and quality of examination procedures (20%).Development and implementation of NMS, is very useful for identification, record and RCA of NCs. NMS, helps to identify the area of QMS in need of attention as well suggest the corrective and preventive actions. It guides, decision making for developing a robust QMS system. Moreover, correct method of RCA is important in comprehensive evaluation of cause and prevention of the NCs.