Quality Evaluation of Clinical Biochemistry Laboratory against ISO 15189:2007 Standard

Sinha, Rajesh Kumar and Raghavan, Vivek M and Pias, Sunronce (2013) Quality Evaluation of Clinical Biochemistry Laboratory against ISO 15189:2007 Standard. International Journal of BioSciences, Healthcare Technology and Management, 5 (2). pp. 11-15. ISSN 0975 3893

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Abstract

Background: The NABL standard provides an opportunity to continually improve the quality clinical lab test results. Objective: The study was conducted to evaluate the compliance of biochemistry lab test as per ISO 15189:2007 standard. Methodology: A prospective study was conducted in a tertiary - care cardiac center of southern India. A validated check list consists of pre - analytic al, analytical, post - analytical phases of lab test based on ISO standard was used to evaluate 30 samples for 21 blood parameters. Result: In Pre analytical phase, 21 parameters were evaluated using the checklists, which showed an average of approximately 8 2% of compliance whereas the analytical phase evident an approximate 97% and the Post analytical showed 74% respectively. Conclusion: The result of the study gives an insight to look into the areas of clinical biochemistry lab where the improvement is requ ired in achieving quality test results in compliance with ISO standards.

Item Type: Article
Uncontrolled Keywords: National Accreditation Board for Testing and Calibration Laboratories; ISO/IEC; Standard, Laboratory; Biochemistry; Quality Evaluation; Quality Assurance
Subjects: Allied Health > MCOAHS Manipal > Health Information Management
Allied Health > MCOAHS Manipal > Medical Laboratory Tech
Depositing User: KMC Manipal
Date Deposited: 12 Dec 2013 09:42
Last Modified: 12 Dec 2013 09:42
URI: http://eprints.manipal.edu/id/eprint/137951

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