Quality Indicators in Laboratory Medicine: From theory to practice: Preliminary data from the IFCC Working Group Project "laboratory Errors and Patient Safety"

Department of Laboratory Medicine and Center of Biomedical Research, University Hospital of Padova, Padova, Italy.
Clinical Chemistry and Laboratory Medicine (Impact Factor: 2.71). 02/2011; 49(5):835-44. DOI: 10.1515/CCLM.2011.128
Source: PubMed


The adoption of Quality Indicators (QIs) has prompted the development of tools to measure and evaluate the quality and effectiveness of laboratory testing, first in the hospital setting and subsequently in ambulatory and other care settings. While Laboratory Medicine has an important role in the delivery of high-quality care, no consensus exists as yet on the use of QIs focussing on all steps of the laboratory total testing process (TTP), and further research in this area is required.
In order to reduce errors in laboratory testing, the IFCC Working Group on "Laboratory Errors and Patient Safety" (WG-LEPS) developed a series of Quality Indicators, specifically designed for clinical laboratories. In the first phase of the project, specific QIs for key processes of the TTP were identified, including all the pre-, intra- and post-analytic steps. The overall aim of the project is to create a common reporting system for clinical laboratories based on standardized data collection, and to define state-of-the-art and Quality Specifications (QSs) for each QI independent of: a) the size of organization and type of activities; b) the complexity of processes undertaken; and c) different degree of knowledge and ability of the staff. The aim of the present paper is to report the results collected from participating laboratories from February 2008 to December 2009 and to identify preliminary QSs.
The results demonstrate that a Model of Quality Indicators managed as an External Quality Assurance Program can serve as a tool to monitor and control the pre-, intra- and post-analytical activities. It might also allow clinical laboratories to identify risks that lead to errors resulting in patient harm: identification and design of practices that eliminate medical errors; the sharing of information and education of clinical and laboratory teams on practices that reduce or prevent errors; the monitoring and evaluation of improvement activities.

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Available from: Laura Sciacovelli, Aug 14, 2014
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    • "It has been suggested that along with handling of critical results, correct identification should be given the highest priority in the extra-analytical phases [32]. An IFCC working group has suggested that optimum performance should be a patient identification error percentage of less than 0.4% [9]. Identification errors also include mismatching of the patient identity given on the sample tube and the request form as well as adding an incorrect requesting physician [10] [32]. "
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    ABSTRACT: Harmonisation is likely to be an important contributor to ensure high quality laboratory testing, thus potentially improving patient outcome. Efforts for harmonisation must be made in the total testing process, from test requesting to communication of the laboratory test results and its consequences to the patient. In this article, suggestions are given about what level of harmonisation is possible at the various steps of the testing process, who could be responsible for facilitating and monitoring the effects of harmonisation, and what are likely barriers to achieving harmonisation. Harmonisation can be achieved at local, national and international levels, and will be most challenging when it involves more than one profession as in the extra-analytical phases. Key facilitators will be laboratory associations, regulatory bodies and accreditation systems, whereas barriers are likely to be reimbursement systems or economic factors, opinion leaders and manufacturers. A challenge is to try to turn barriers into facilitators. Harmonisation effects can in most settings be monitored by external quality assurance organisations provided that schemes are expanded to cover all relevant steps and phases. We must combine our efforts, both within our profession as well as in cooperation with others, to achieve harmonisation of the total testing process, in the best interests of the patient.
    Clinica chimica acta; international journal of clinical chemistry 12/2013; 432. DOI:10.1016/j.cca.2013.12.005 · 2.82 Impact Factor
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    • "Nevertheless these criteria represent excellent starting points for laboratories in setting benchmarks for extra-analytical quality monitoring and are a significant step forward in developing consensus standards [81]. The group plans to eliminate and modify some existing indicators and develop new ones over the next year [81]. The project's success depends on the participation and collaboration of laboratories enrolled in the project to help define best practice and improve performance and laboratories interested in participating are encouraged to contact the group through the website mentioned above. "
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    ABSTRACT: For many years, the clinical laboratory's focus on analytical quality has resulted in an error rate of 4-5 sigma, which surpasses most other areas in healthcare. However, greater appreciation of the prevalence of errors in the pre- and post-analytical phases and their potential for patient harm has led to increasing requirements for laboratories to take greater responsibility for activities outside their immediate control. Accreditation bodies such as the Joint Commission International (JCI) and the College of American Pathologists (CAP) now require clear and effective procedures for patient/sample identification and communication of critical results. There are a variety of free on-line resources available to aid in managing the extra-analytical phase and the recent publication of quality indicators and proposed performance levels by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on laboratory errors and patient safety provides particularly useful benchmarking data. Managing the extra-laboratory phase of the total testing cycle is the next challenge for laboratory medicine. By building on its existing quality management expertise, quantitative scientific background and familiarity with information technology, the clinical laboratory is well suited to play a greater role in reducing errors and improving patient safety outside the confines of the laboratory.
    Annals of Laboratory Medicine 01/2012; 32(1):5-16. DOI:10.3343/alm.2012.32.1.5 · 1.48 Impact Factor
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    ABSTRACT: Background. In the C. Poma Hospital of Mantua we have been using a system of continuous surveillance of nosocomial infections based on microbiological data for the past 4 years. This monitoring estimates the incidence of the microorganisms found in cultures, especially those at risk of causing nosocomial infections. Materials and methods. Since June 2001 microbiological data have been registered using the Mercurio-Dianoema software and elaborated by means of Microsoft Excel in order to obtain information about isolated bacteria, especially those resistant to antibiotics. Results. Surveillance in "critical" wards revealed the presence of Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans in the intensive care unit in the period 2003-2005. The most frequent bacteria in hemodialysis have been coagulase-negative Staphylococci and Staphylococcus aureus, with variable methicillin resistance. Conclusion. The analysis of microbiological data has promoted effective measures to reduce the incidence of these bacteria (increased rules of good practice, hand washing, etc.). If nosocomial infections or high-risk microorganisms occur, assessments are carried out; monitoring of the antibiotic resistance of the bacteria is very important. (G Ital Nefrol 2007; 24: (Suppl. S38) S33-8) Conflict of interest: None
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