Laura Sciacovelli

Quality Indicators in Laboratory Medicine: from theory to practice

Abstract Background: 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. Methods: 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. Results and conclusions: 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.

Evaluation of Effectiveness of a Computerized Notification System for Reporting Critical Values

Failure to adequately communicate a critical laboratory value is a potential cause of adverse events. Accreditation requirements specify that clinical laboratories must undertake assessments and appropriate measures to improve the timeliness of critical value reporting and prompt receipt by the responsible caregiver. Documentation and communication processes must be regularly monitored and implemented under ongoing systems for quality monitoring. Critical value reporting is an important phase of the clinical laboratory testing process, and notifications of results outside the target time can indicate ineffectiveness of the process. In the present study, we report data obtained in a 12-month period of critical values analysis and describe a computerized communication system conducive to improving the quality of critical value reporting at a university hospital. Automated communication improves the timeliness of notification and avoids the potential errors for which accreditation programs require read-back of the result. The communication also improves the likelihood of reaching the physician on call and may provide important decision support.

Harmonization of quality indicators in laboratory medicine. A preliminary consensus

Abstract Quality indicators (QIs) are fundamental tools for enabling users to quantify the quality of all operational processes by comparing it against a defined criterion. QIs data should be collected over time to identify, correct, and continuously monitor defects and improve performance and patient safety by identifying and implementing effective interventions. According to the international standard for medical laboratories accreditation, the laboratory shall establish and periodically review QIs to monitor and evaluate performance throughout critical aspects of pre-, intra-, and post-analytical processes. However, while some interesting programs on indicators in the total testing process have been developed in some countries, there is no consensus for the production of joint recommendations focusing on the adoption of universal QIs and common terminology in the total testing process. A preliminary agreement has been achieved in a Consensus Conference organized in Padua in 2013, after revising the model of quality indicators (MQI) developed by the Working Group on “Laboratory Errors and Patient Safety” of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The consensually accepted list of QIs, which takes into consideration both their importance and applicability, should be tested by all potentially interested clinical laboratories to identify further steps in the harmonization project.

Performance criteria and quality indicators for the pre-analytical phase

Abstract The definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

Proficiency testing project for brain natriuretic peptide (BNP) and the N-terminal part of the propeptide of BNP (NT-proBNP) immunoassays: the CardioOrmocheck study.

Abstract Background: We organized and conducted a proficiency testing study (CardioOrmocheck) to evaluate the differences in analytical performance of brain natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) immunoassays. Methods: Approximately 90 Italian laboratories were involved in the 2005–2007 proficiency testing cycles, while 112 laboratories took part in the 2008 cycle (from January to May 2008). A total of 28 study samples were measured by participating laboratories for a total of 2354 determinations. Results: The mean total variability for BNP (50.6 %CV) was significantly higher than that for NT-proBNP (8.4 %CV). In addition, the mean variability due to differences between-methods (46.4 %CV) comprised the majority of the total variability for BNP. Between-method variability for BNP comprised, on average, 84% of total variability, while the within-method variability comprised an average of 20.2 %CV. On the contrary, for NT-proBNP the within-method variability (7.3 %CV) represented the majority of total variability (average 75%), while between-method variability was smaller (4.1 %CV). Imprecision around the cut-off value showed marked differences among methods, especially for BNP immunoassay methods. In addition, BNP methods were affected by large systematic differences, for example an average 2.7-fold difference between Access and ADVIA Centaur methods, while agreement between NT-proBNP methods was better (an average 1.2-fold difference between Dimension and ECLIA on the Elecsys methods). Conclusions: This multicenter collaborative study demonstrates that there are significant differences in analytical characteristics and measured values among the most popular commercial methods for BNP and NT-proBNP. Clinicians should be very careful when comparing results obtained by laboratories that use different methods. Clin Chem Lab Med 2009;47:762–8.

Harmonization of pre-analytical quality indicators

Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra-laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.

Towards harmonization of quality indicators in laboratory medicine

Abstract The identification of reliable quality indicators (QIs) in the total testing process (TTP) represents a crucial step in enabling users to quantify the quality of laboratory services, but the current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence showing the multitude of errors that continue to occur in the pre- and post-analytical phases. Although interesting programs on indicators of the extra-analytical phases have been developed in some countries, there is no consensus on the production of joint recommendations for the adoption of universal QIs and the use of common terminology in the total testing process. In view of the different QIs and terminologies currently used, there an urgent need to harmonize proposed QIs, which should comply with three main principles: they must be patient-centered, consistent with the requirements of the International Standard for medical laboratories accreditation, and address all stages of the TTP. A model of quality indicators (MQI), consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), includes 56 QIs related to key processes (34 pre-, 7 intra- and 15 post-analytical phase) and three to support processes. The scope of harmonization in laboratory medicine, more far-reaching than method harmonization, should cover a wider range of topics, namely all steps of the “brain-to-brain loop”. The identification of valuable QIs is a key step in paving the way towards quality and patient safety in laboratory medicine.

Quality indicators in laboratory medicine: A fundamental tool for quality and patient safety

OBJECTIVES The identification of reliable quality indicators (QIs) is a crucial step in enabling users to quantify the quality of laboratory services. The current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence pointing to the multitude of errors that continue to occur in the pre- and post-analytical phases. DESIGN AND METHODS Different QIs and terminologies are currently used and, therefore, there is the need to harmonize proposed QIs. RESULTS A model of quality indicators (MQI) has been consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The model includes 57 QIs related to key processes (35 pre-, 7 intra- and 15 post-analytical phases) and 3 to support processes. CONCLUSIONS The developed MQI and the data collected provide evidence of the feasibility of the project to harmonize currently available QIs, but further efforts should be done to involve more clinical laboratories and to collect a more consistent amount of data.

Assessment of critical values policies in Italian institutions: comparison with the US situation

Abstract Background: Critical value reporting is considered an essential tool to ensure the quality of medical laboratory services. Important issues include defining cut-off values, assessing responsibility for communication and adopting information technology solutions to improve notification. Here, we report the state of critical value reporting in a large cohort of Italian laboratories and comparison with Q-Probes surveys from the College of American Pathologists as representatives of the US situation. Methods: To compare critical value policies and procedures, formulation of critical values list with critical values limits and monitoring tools, a web-based questionnaire was formulated for 389 institutions participating in the External Quality Assessment Schemes of Veneto Region, in Italy. Results: A total of 90 clinical laboratories submitted data. Accredited laboratories represented 82.2% of participants, but written procedures for reporting were indicated by 70.5% of participants. Relevant differences between US and Italian policies have been observed, particularly regarding who provides the notification and on the formulation of the cut-off threshold for critical values. Conclusions: Accreditation according to international standards can decrease differences regarding the management of critical values across laboratories of different countries. However, the issues concerning critical limits should be debated and a consensus critical values list should be considered. Automated systems could offer improvements regarding some issues, such as who makes the notification, reducing the time spent in notification of critical values. Surveys for comparing and improving existing policies regarding critical values should be promoted at an international level. Clin Chem Lab Med 2010;48:461–8.

Quality indicators for laboratory diagnostics: consensus is needed.

Barth has provided a comprehensive overview on clinical quality indicators of the total testing process, i.e. throughout the preanalytical, analytical and postanalytical phases of laboratory practice. We agree on the essential concept that a paradigm shift might occur in the delivery of laboratory medicine towards a clinical service measured by outcomes, as well as on the importance of the ‘pre–pre’ and ‘post–post’ analytical phases in assuring patient safety. In addition, it should be welcome that a high proportion of UK laboratories provide an advisory and interpretative service to their users. This seems to represent a further step in improving quality in the whole ‘brain-to-brain loop’ and in avoiding errors that may jeopardize patient safety. Although the concern raised in the article about the ‘paucity of literature on quality indicators’ was indeed founded some years ago, a huge number of nationwide experiences are ongoing and consistent data on this topic have already been gathered. Along with the worldwide project of the International Federation of Clinical Chemistry Working Group on laboratory errors and patient safety, other valuable experiences are ongoing in several countries, such as those supported by the Association for Clinical Biochemistry, the Sociedad Española de Bioquı́mica Clı́nica y Patologı́a Molecular, the external quality assessment scheme developed in Croatia for monitoring the extraanalytical areas of testing, as well as the over 12-year series of pilot preand postanalytical programmes that have been developed and trialled in volunteer pathology laboratories throughout Australia and New Zealand. In the USA, the Centers for Disease Control and Prevention convened a conference in 2007 aimed to improve laboratory services. Five major recommendations emerged including focusing on preanalytic and postanalytic processes as areas of potential quality improvement. Therefore, the leading issue can no longer be identified as a ‘paucity’ of data, but rather the independent and somehow disharmonic outburst of national or supranational initiatives, which are currently based on heterogeneous and not always comparable sets of quality indicators and related terminology. There is now a compelling need to reorganize and possibly unify these ongoing projects, as well as establish an international consensus for producing joint recommendations focused on the adoption of universal quality indicators and common terminology. This is supported by a recent review which concluded that current laboratory medicine quality indicators did not fulfil minimum standard evaluation criteria for quality or performance measures, thereby highlighting the need for consistently specified, reliable, useful, and evidence-based, laboratory-related quality and performance measures. Inherent to this process, the term ‘reliable’ designates that quality indicators should be mostly ‘patient-centered’, should be implemented in different types of clinical laboratories worldwide and should provide the ideal basis for establishing a reliable policy of incident reporting in laboratory medicine. We firmly believe that harmonization of practices for monitoring quality throughout the total testing process would result in mature quality assurance programmes capable of identifying and driving real improvements in laboratory medicine and health care.