Piyush Tailor

Abstract

Introduction: Lipemic samples are affecting sample integrity and may raise questions on accuracy of test results. To overcome lipemic interference ultracentrifugation, high speed centrifugation, lipid clearing agent, dilution with normal saline or sample blanking can be used. Out of these, ultracentrifugation is likely to cause least interference as there is minimal exposure to additional chemicals. Aims and Objectives: The study was conducted to compare the results obtained for some commonly asked biochemical parameters, before and after ultracentrifugation and to assess the need of removal of lipemia using ultracentrifugation as a tool for these parameters. Materials and Methods: From 50 lipemic samples, 2 aliquots were prepared each having 500 microliter of serum. Out of these 2, one was used to perform amylase, urea, creatinine, glucose and uric acid. From Second aliquot, same parameters were performed after ultracentrifugation and comparison of results obtained, was done by Student’s t-test. Moreover, ratio of % lipemic bias to CLIA criteria, biological variation and % coefficient of variance of laboratory were also calculated to see whether the difference is clinically significant too. Results: Statistically significant difference between lipemic and ultracentrifuge samples was observed in amylase, urea, creatinine, uric acid and glucose while only glucose and uric acid showed clinically significant difference. Conclusion: Lipemia causes statistically significant interference in estimation of amylase, urea, creatinine, glucose and uric acid and ultracentrifugation is very effective process in removal interference caused by lipemia. When this statistically significant interference was studied in the light of clinical need, only glucose and uric acid showed clinically significant interference. Laboratories not equipped with ultracentrifuge, can use kinetic method, two point kinetic method or at least two reagents method as alternative. Keywords: Amylase, Clinical chemistry, Creatinine, Glucose, Interferences, Urea, Uric acid.

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Abstract

Introduction: 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. Aim: The aim of the study is to supplement the knowledge and to provide guidance about development of NMS in accordance with the accreditation requirements. Materials and Methods: 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. Results and Discussion:  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%). Conclusion: 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.   Keywords: Accreditation, Biochemistry, Nonconformance, Root Cause Analysis (RCA)

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