Volume 13, Issue 1 (Jan-Feb 2019)                   mljgoums 2019, 13(1): 37-41 | Back to browse issues page

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Tamil Selvi M, Ankanagari S. Implementing QMS and Accreditation Standards in Medical Diagnostics for Quality of Services. mljgoums. 2019; 13 (1) :37-41
URL: http://mlj.goums.ac.ir/article-1-1144-en.html
1- Value added Corporate Services Pvt. Ltd, Chennai (T.N), India – 600 090
2- Osmania University
Abstract:   (818 Views)
Implementing quality management system (QMS) in medical laboratories ensures quality techniques and enhances the laboratory staff skills development. It mainly prevents frequent inaccuracies which occur in both clinical and laboratory procedures due to lack of regulatory compliance, safety precautions and inadequate facilities including less trained or inexperienced manpower. Current standards enforce comprehensive quality assisted operations in all laboratory activities. Awareness of standards and implementing the standards in laboratory process and procedures and monitoring the same by following quality management system show that personnel knowledge is considered one of important aspect which is linked to high percentage of laboratory error/reworking (non conformities). The purpose of this study is to give overview on  the implementation of quality management system based on essential standards NABH (MLP), NABL (ISO 15189:2012) for medical laboratories and how the standards helps to increase the consistency in quality services in diagnostic laboratories. By checking important quality indicators such as EQAS, TAT and feedback has shown great reduction in the laboratory errors/rework percentages after implementing the QMS as per the standard requirements in the laboratory. In addition it also helps to develop a good communication between the clinicians and laboratory personnel in the laboratories to ensure continual improvement in the laboratory practices which satisfies the customer requirements.
Full-Text [PDF 401 kb]   (161 Downloads)    
Type of Study: Original Paper | Subject: Laboratory Sciences
Received: 2018/11/23 | Accepted: 2018/12/22 | Published: 2018/12/22 | ePublished: 2018/12/22

1. Haeckel R, Kindler M. Effect of current and forthcoming European legislation and standardization on the setting of quality specifications by laboratories. Scandinavian journal of clinical and laboratory investigation.1999; 59: 569-73. [DOI:10.1080/00365519950185373]
2. National Accreditation Board for Hospitals and Healthcare Providers (NABH). Medical Laboratory Program: Registered Private Labs [Internet].http://www.nabh.co/main/mlp/complied_pvt.asp.
3. National Accreditation Board for Testing and Calibration Laboratories (NABL): http://www.nabl- india.org/nabl/index.php?c=search&m=index.
4. Lee PKC, To WM, Yu BTW. The implementation and performance outcomes of ISO 9000 in service organizations: An empirical taxonomy. International Journal of Quality & Reliability Management. 2009; (26): 7. [DOI:10.1108/02656710910975732]
5. McAdam R, Canning N. ISO in the service sector: Perceptions of small professional firms. Managing Service Quality. 2001; 11(2): 80-92. https://doi.org/10.1108/09604520110387202 [DOI:10.1108/09604520110387202.]
6. Archondakis, Stavros, Vavoulidis, Eleftherios, Nasioutziki, Maria. The Use of Mobile Health Applications for Quality Control and Accreditational Purposes in a Cytopathology Laboratory. 2016; 262-283. DOI: 10.4018/978-1-4666-9861-1.ch013. [DOI:10.4018/978-1-4666-9861-1.ch013]
7. Rana BK, Behera NS, Nair SB. QCI - Medical laboratory program journey of quality in public medical laboratories": An experience though program evaluation. J Nat Accred Board Hosp Healthcare Providers. 2014; 1(1): 7-11. [DOI:10.4103/2348-6139.132915]
8. Lippi G, Plebani M, Ana-Maria Simundic. Quality in laboratory diagnostics: from theory to practice. BiochemiaMedica 2010; 20(2):126-30. [DOI:10.11613/BM.2010.014]
9. Guzel O and Guner EI. ISO 15189 Accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory. Clinical Biochemistry. 2009; 42(4-5): 274-278. [DOI:10.1016/j.clinbiochem.2008.09.011]
10. Theodorsson E. Quality assurance in clinical chemistry.A touch of statistics and a lot of common sense. J Med Biochem. 2016; 35(2): 103-112. doi: 10.1515/jomb-2016-0012. [DOI:10.1515/jomb-2016-0012]
11. Manickam TS and Srinivas A. Evaluation of quality management systems implementation in medical diagnostic laboratories benchmarked for accreditation. 2015; 6(5): 27-35.
12. Rahman Md. Quality Assurance (QA) in Laboratory Testing. Anwer Khan Modern Medical College Journal.2. 2011; 10.3329/akmmcj.v2i2.8163. [DOI:10.3329/akmmcj.v2i2.8163]
13. Paul RE. Quality control in clinical laboratory samples. 2015; https://www.mlo-online.com/quality-control-in-clinical-laboratory-samples.php.
14. Khatri R, Shrestha P, Sinha JN. Implementing self-sustained quality control procedures in a clinical laboratory. Journal of Nepal Medical Association. 2013; 52(189): 233-237. [DOI:10.31729/jnma.560]
15. Sarah B, Michael AM, Elisabeth D. Approaches to quality management and accreditation in a genetic testing laboratory. Eur J Hum Genet. 2010; 18 Suppl 1: S1-19. doi: 10.1038/ejhg.2010.104. [DOI:10.1038/ejhg.2010.104]
16. Schneider F, Maurer C, Friedberg RC. International Organization for Standardization (ISO) 15189. Ann Lab Med. 2017; 37(5): 365-370. [DOI:10.3343/alm.2017.37.5.365]
17. Carey RB, Bhattacharyya S, Kehl SC, Matukas LM, Pentella MA, Salfinger M, et al. Implementing a Quality Management System in the Medical Microbiology Laboratory. Clin Microbiol Rev. 2018; 31(3). pii: e00062-17. doi: 10.1128/CMR.00062-17. [DOI:10.1128/CMR.00062-17]

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