Implementation of a Risk Management Model to Identify andPrevent Preanalytical Errors in Medical Laboratories

Objective: The aim of the study is to apply a risk management model for the examination and prevention of errors occurring in the preanalytical laboratory phase. Method: The data used in this study were obtained from the Error Reporting Sheet of Dokuz Eylul University Hospital Central Laboratory for 2013–2015. The Failure Mode and Effects Analysis (FMEA) method was used in the study. The pre-analytical laboratory process was defined and FMEA team was formed. By determining the potential effects of failure modes detected in the pre-analytical process, the severity, probability and detectability of them were calculated and potential causes were identified. An action plan was prepared to eliminate or reduce the highrisk failure modes. Results: In the pre-analytical laboratory phase, processes are defined as test request, sampling, identification, barcoding and transfer. The errors that occurred in the pre-analytical phase were classified under 9 types of errors. The highest number of errors was observed in the patient identification process and the number and the ratio of total errors in 2013 are 71 (29.58%), in 2014 it is 81 (29.89%) and in 2015 it is 102 (53.97%). It was observed that the failure mode with the highest risk priority number value with 576 points in the pre-analytical phase occurred in the identification process. Conclusion: With the FMEA procedure that can be included in the laboratory’s quality system, it is expected to minimize the possibility of errors in the pre-analytical phase and improve the quality of laboratory tests.

PDF

___

Trivedi P, Shah N, Ramani KV. Managing clinical laboratories: Monitor and control lab errors to improve lab performance. IIMA Working Papers WP2011-11-02, Indian Institute of Management Ahmedabad, Research and Publication Department; 2011.
Turkish Ministry of Health. Tarhan D, Erdoğan S, Çiçek AÇ, editörler. Quality Management Guide for Clinical Microbiology Laboratories 2014. https://dosyamerkez.saglik.gov.tr/Eklenti/3531,kitaplabpdf. pdf?0
World Health Organization. Guidelines for Establishment of Accreditation of Health Laboratories 2007. https://www.who.int/ihr/ training/laboratory_quality/11_cd_rom_publications_sea_hlm_394.pdf
Plebani M. Errors in clinical laboratories or errors in laboratory medicine. Clin Chem Lab Med 2006;44:750–9. [CrossRef]
Havens DH, Boroughs, L. “To err is human”: A report from the Institute of Medicine. J Pediatr Health Care 2000;14:77–80. [CrossRef]
Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691–698. [CrossRef]
Mendes ME, Ebner PAR, Romano P, Pacheco NM, Sant’anna A, Sumita NM. Practical aspects of the use of FMEA tool in clinical laboratory risk management. J Bras Patol Med Lab 2013;49:174–181. https:// www.scielo.br/pdf/jbpml/v49n3/04.pdf
Wagar EA, Tamashiro L, Yasin B, Hilborne L, Bruckner, DA. Patient safety in the clinical laboratory: A longitudinal analysis of specimen identification errors. Arch Pathol Lab Med 2006;130:1662–1668. [CrossRef]
The Joint Commission. Accreditation Guide for Hospitals 2011. https://www.jointcommission.org/-/media/ deprecated-unorganized/imported-assets/tjc/system-folders/ assetmanager/accreditation_guide_hospitals_2011pdf. pdf?db=web&hash=350D19DE3CEF201A9C270B07B7D0FBCD
Lippi G, Chiozza L, Mattiuzzi C, Plebani M. Patient and sample identification. Out of the maze? J Med Biochem 2017;36:107–112. [CrossRef]
Lippi G, Guidi G. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med 2007;45:720–727. [CrossRef]
Najafpour Z, Hasoumi M, Behzadi F, Mohamadi E, Jafary M, Saeedi M. Preventing blood transfusion failures: FMEA, an effective assessment method. BMC Health Serv Res 2017;17:453. [CrossRef]
Lippi G, Blanckaert N, Bonini P, et al. Causes, consequences, detection, and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med 2009;47:143–153. [CrossRef]
Wallin O, Söderberg J, Van Guelpen B, Stenlund H, Grankvist K, Brulin C. Blood sample collection and patient identification demand improvement: A questionnaire study of preanalytical practices in hospital wards and laboratories. Scand J Caring Sci 2010;24:581–591. [CrossRef]
LLopis MA, Alvarez V, Martnez-Bru C, et al. Quality assurance in the preanalytical phase. Applications and Experiences of Quality Control 2012:185–204. https://www.intechopen.com/books/applicationsand-experiences-of-quality-control/quality-assurance-in-thepreanalytical-phase
International Organization for Standardization. ISO 15189 Medical Laboratories - Requirements for Quality and Competence. Geneva: 2012. https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-3:v2:en
Sholadem BA. Identification and reduction of pre-analytical errors in clinical chemistry through expert advice (Doctoral dissertation, Sheffield Hallam University, Sheffield, United Kingdom, 2017).