Impact of NABL on Quality Indicators of Pre-Analytical Phase of Testing in Tertiary Care Hospital
Keywords:
NABL, The International Federation of Clinical Chemistry (IFCC), Quality indicators, Defect per million, Six sigma
Abstract
Introduction: The laboratory’s compliance to requirements of the standard and its technical competence are assessed by NABL for accreditation. QIs should be part of a coherent and integrated quality improvement strategy implemented according to the specifically developed International Standard for Medical Laboratories Accreditation (ISO 15189: 2012). Pre-analytical errors account for more than 70% of the total number of laboratory errors. The International Federation of Clinical Chemistry (IFCC) and Laboratory Medicine Working Group on Laboratory Errors and Patient Safety (WG-LEPS) has made an important contribution to developing QIs for the preanalytical phase and specifications for those indicators. We selected following QIs pertaining to the key activities of the pre-analytical phase. These were: Hemolyzed samples (in biochemistry; QI-10b); Samples with inadequate quantity (QI-12). Material and Method: QI-10b and 12 were recorded from ‘Sample rejection register’ and ‘Sample transport register’. We calculated the sigma metric for these QIs. First, we calculated the Defect Per Million (DPM) then the DPM rate was converted to a sigma value. Result After NABL accreditation improvement in six sigma values of QI-10b is 4.0-5.0, suggests ‘Good’ level of performance and for QI-12 shows between 3.0-4.0, no significant improvement. Conclusion NABL accreditation does not make any statement about the technical competence of the laboratory. As continual improvement is necessary for the good laboratory practice, we continue to collect data regarding errors to monitor this critical phase of laboratory testing to ensure ongoing satisfactory performance.References
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14. Fabio Triachini Codagnone; Sibelle Mattos Flores Alencar et al. The use of indicators in the pre-analytical phase as a laboratory management tool. J Bras Patol Med Lab, v. 50, n. 2, p. 100-104, april 2014.
15. Sciacovelli L, Sonntag O, Padoan A, Zambon CF, Carraro P, PlebaniM. Monitoring quality indicators in laboratory medicine does notautomatically result in quality improvement. Lab Med. 2011;50:463-469.
16. Chawla, R. et al. Identification of the types of preanalytical errors in the clinical chemistry laboratory: 1-year study at G.B. Pant Hospital. Lab Medicine, v. 41, n. 2, p. 89-92, 2010.
17. Laga C.,Cheves A. Sweeney D. The effect of specimen hemolysis on coagulation test results. Am J Clin Pathol, v. 126, n. 5,p. 748-55, 2006..
18. Lippi G. et al. Interference of blood cell lysis on routine coagulation tests. Arch Pathol Lab Med, v. 130, n. 2, p. 181-4, 2006.
19. Smith T. Effect of in vitro hemolysis on assay of plasma catecholamines and DOPA centrifugation. Clin Chem, v. 26, n. 9, p. 1354-6, 1980.
20. Yücel, D.; Dalva K. Effect of in vitro hemolysis on 25 common biochemical tests. Clin Chem,v.38,n.4,p.575-7,1992.
2.International Organization for Standardization (ISO). ISO 15189:2007: Medical laboratories: particular requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization; 2007
3.Carraro P, Plebani M. Mistakes in a stat laboratory: types and frequency 10 years later. Clin Chem. 2007; 53:1338–42.
4.Sciacovelli L, Plebani M. The IFCC working group on laboratory errors and patient safety. ClinChimActa. 2009; 404:79-85.
5.Plebani M, Sciacovelli L, Lippi G. Quality indicators for laboratory diagnostics: consensus is needed. Ann ClinBiochem. 2011; 48:479.
6.Sciacovelli L, O’Kane M, Skaik YA. Quality indicators in laboratory medicine: from theory to practice. Preliminary data from the IFCC Working Group Project “Laboratory Errors and Patient Safety”.ClinChem Lab Med. 2011;49:835-844.
7.Coskun A, Unsal I, Serteser M, Inal T. Six Sigma as a Quality Management Tool: Evaluation of Performance in Laboratory Medicine,Quality Management and Six Sigma.Rijeka, Croatia: InTech Europe;2010.
8.Westgard JO, Westgard SA. The quality of laboratory testing today. An assessment of σ metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance.Am J ClinPathol. 2006; 125:343-354.
9.Westgard JO, Klee GG. Quality management. In: Burtis CA, Ashwood ER, Bruns DE.editor. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics.St. Louis,MO: Elsevier Saunders Inc.;2006.
10.Nevalainen D, Berte L, Kraft C, Leigh E, Picaso L, Morgan T. Evaluating laboratory performance on quality indicators with the Six Sigma scale. Arch Pathol Lab Med. 2000; 124:516-519.
11.Daniela Stefania G., D.Aliborca Cristina viad. Quality indicators on preanalytical phase of testing in a stat Laboratory. LA Medicine.2014;74-80
12.Goswami B., Singh B., Chawla R. Evaluation of errors in a clinical laboratory: a one-year experience. Clin Chem Lab Med, v. 48, n. 418, p. 63-6, 2010.
13. Lima-oliveira, G. D. S. et al. Controle da qualidade na coleta do espécime diagnóstico sanguíneo: iluminando uma fase escura de erros. J Bras Patol Med Lab, v. 45, n. 6, p. 441-7, 2009.
14. Fabio Triachini Codagnone; Sibelle Mattos Flores Alencar et al. The use of indicators in the pre-analytical phase as a laboratory management tool. J Bras Patol Med Lab, v. 50, n. 2, p. 100-104, april 2014.
15. Sciacovelli L, Sonntag O, Padoan A, Zambon CF, Carraro P, PlebaniM. Monitoring quality indicators in laboratory medicine does notautomatically result in quality improvement. Lab Med. 2011;50:463-469.
16. Chawla, R. et al. Identification of the types of preanalytical errors in the clinical chemistry laboratory: 1-year study at G.B. Pant Hospital. Lab Medicine, v. 41, n. 2, p. 89-92, 2010.
17. Laga C.,Cheves A. Sweeney D. The effect of specimen hemolysis on coagulation test results. Am J Clin Pathol, v. 126, n. 5,p. 748-55, 2006..
18. Lippi G. et al. Interference of blood cell lysis on routine coagulation tests. Arch Pathol Lab Med, v. 130, n. 2, p. 181-4, 2006.
19. Smith T. Effect of in vitro hemolysis on assay of plasma catecholamines and DOPA centrifugation. Clin Chem, v. 26, n. 9, p. 1354-6, 1980.
20. Yücel, D.; Dalva K. Effect of in vitro hemolysis on 25 common biochemical tests. Clin Chem,v.38,n.4,p.575-7,1992.
Published
2019-05-01
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