Quality assessment and good laboratory practice in clinical chemistry laboratory at diagnostic laboratories in Nepal

Gyawali, Prabin; Lamsal, Nitesh; Tamrakar, Suman Raj; Shrestha, Raj K.; Aryal, Pratibha; Raut, Binay; Aryal, Madhukar

doi:10.1016/j.clinbiochem.2011.08.013

Cited by 2 publications

(3 citation statements)

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“…Commercially available quality control materials have to be imported from abroad. 10,11 This study demonstrates how a homemade control material can be used for QC procedures. It also demonstrates a simple method of interpreting and analysing the output to guarantee the validity and reliability of the system.…”

Section: Discussionmentioning

confidence: 92%

Implementing Self Sustained Quality Control Procedures in a Clinical Laboratory

Khatri

Shrestha

et al. 2013

J Nepal Med Assoc

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Introduction: Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be “too technical” whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. Methods: The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. Results: The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients’ samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. Conclusions: In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports. Keywords: Levey-Jennings charts; pooled sera; quality control; Westgard Rule.

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Section: Discussionmentioning

confidence: 92%

Implementing Self Sustained Quality Control Procedures in a Clinical Laboratory

Khatri

Shrestha

et al. 2013

J Nepal Med Assoc

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“…4,[8][9]19 In a study on practice of QA and good laboratory practice (GLP) in clinical chemistry laboratory at diagnostic laboratories in Nepal done by Gyawali P et al,2011 have reported that only 20.0% of the clinical laboratories use QC materials for internal quality control (IQC) and proficiency testing (PT), in addition only 46.7% of the laboratories participated in EQAS programme but majority did not responded regarding VIS score. 10 Thus, alternative approach or strict guidelines regarding use of QA should be executed.…”

Section: Discussionmentioning

confidence: 99%

“…4 The current dominant technique for errors identification uses quality control materials which are inadequate for several reasons : are most sensitive to errors in instrument calibration, the expense of the material, appropriate storage of material may present a problem in some facilities, the material may be unstable once reconstituted and put into use, stored material may slowly deteriorate even if maintained in an appropriate manner, constituents such as enzymes and other proteins may be of animal origin and not react with reagents in the same manner as their human counterparts etc.. 4,9 Also, the concepts of Quality Assessment (QA) or QC or external quality control scheme (EQAS) programme, still have to gain widespread acceptance among Nepalese laboratories. 10 An alternative approach is the use of patient data or patients based quality control that includes the use of: delta checks, limit checks, patient duplicates, discordance checks, multi-parametric checks of individual patient data (e.g. anion gaps) and average of patient results moreover delta check being the commonly preferred method.…”

Section: Introductionmentioning

confidence: 99%

Practice of patient based quality assessment procedure in clinical chemistry unit at diagnostic laboratories in Nepal

Gyawali

Tamrakar

Lamsal

et al. 2013

Sunsari Tech. Coll. J.

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Background: The clinical laboratory is the major producer of information used to diagnose, treat, and monitor patients. Errors in laboratory testing may occur at many different points in the total testing process (TTP). Application of quality control plays a vital role in recognizing probable errors. The current dominant technique for error identification uses quality control materials has several inherent drawbacks; otherwise, patient based quality control procedure ensures the detection of pre-analytical errors, analytical, post-analytical errors, clerical errors, and random errors that cannot be detected using commonly used quality control methods, thereby improving the reliability of clinical tests. Objective: Thus the objective of this study was to evaluate the practice of patient based quality control procedure in clinical chemistry unit at diagnostic laboratories in Nepal. Materials and Methods: The questionnaire based study was conducted in clinical chemistry unit of diagnostic laboratories across the country. Questionnaires were personally dropped in 217 clinical biochemistry laboratories and were asked to complete a practice based questionnaire. The responses of 169 laboratories were analyzed using Microsoft Excel 2007 and expressed in terms of percentage. Results: In foremost study undertaken, a total of 169 laboratories responded to the questionnaire. A total 65.9 % of the laboratories monitored errors using patient based quality control procedure but not as a part of quality control. Very few of participant.s laboratories responded accurately regarding utility and practical aspects of patient based quality control included in the checklist. Conclusion: Practice of patient based quality control procedure was not well established to identify possible errors. Hence, the study extent the existing information and explored that the current classical approaches were not adequate to assure accurate patients test results for specific analytes. DOI: http://dx.doi.org/10.3126/stcj.v1i1.7983 Sunsari Technical College Journal Vol.1(1) 2012 9-17

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Quality assessment and good laboratory practice in clinical chemistry laboratory at diagnostic laboratories in Nepal

Cited by 2 publications

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Implementing Self Sustained Quality Control Procedures in a Clinical Laboratory

Implementing Self Sustained Quality Control Procedures in a Clinical Laboratory

Practice of patient based quality assessment procedure in clinical chemistry unit at diagnostic laboratories in Nepal

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