General position of Croatian medical biochemistry laboratories on autovalidation: survey of the Working Group for Post-analytics of the Croatian Society of Medical Biochemistry and Laboratory Medicine

Introduction: Autovalidation (AV) is an algorithm based on predefined rules designed, among others, to automate and standardize the postanalytical phase of laboratory work. The aim of this study was to examine the overall opinion of Croatian medical biochemistry laboratories regarding various aspects of AV. Material and methods: This retrospective study is an analysis of the responses of a survey about AV comprised of 18 questions, as part of Module 10 (“Postanalytical phase of laboratory testing”) of national External Quality Assessment program, administered by the Croatian Centre for Quality Assessment in Laboratory Medicine. Results were reported as percentages of total number of participants in survey or as proportions of observed data if the overall number of data was <100. Results: 121 laboratories responded to the survey, of which 76% do not use AV, while 11% of laboratories use AV in routine laboratory work. 16/29 laboratories implemented semi-automated AV for general biochemistry (7/29), haematology (5/29), and coagulation (4/29) tests. Analytical measurement ranges, critical values, flags from analysers, interference indices and delta check were the most commonly used rules in the algorithm. 12/29 laboratories performed validation of AV with less than 500 samples (8/29). 7/13 laboratories report the percentage of AV being 20-50%, while 10/13 answered that introduction of AV significantly reduced turnaround time (TAT) (for 20 - 25%), especially for biochemistry tests. Conclusions: Despite of its numerous benefits (i.e. shorter TAT, less manual validation, standardization of the postanalytical phase), only a small number of Croatian laboratories use AV

Designing and validating an autoverification system of biochemical test results in Hatay Mustafa Kemal University, clinical laboratory

IntroductionAutoverification (AV) is a postanalytical tool that uses algorithms to validate test results according to specified criteria. The Clinical and Laboratory Standard Institute (CLSI) document for AV of clinical laboratory test result (AUTO-10A) includes recommendations for laboratories needing guidance on implementation of AV algorithms. The aim was to design and validate the AV algorithm for biochemical tests. Materials and methodsCriteria were defined according to AUTO-10A. Three different approaches for algorithm were used as result limit checks, which are reference range, reference range ± total allowable error, and 2nd and 98th percentile values. To validate the algorithm, 720 cases in middleware were tested. For actual cases, 3,188,095 results and 194,520 reports in laboratory information system (LIS) were evaluated using the AV system. Cohen’s kappa (κ) was calculated to determine the degree of agreement between seven independent reviewers and the AV system. ResultsThe AV passing rate was found between 77% and 85%. The highest rates of AV were in alanine transaminase (ALT), direct bilirubin (DBIL), and magnesium (Mg), which all had AV rates exceeding 85%. The most common reason for non-validated results was the result limit check (41%). A total of 328 reports evaluated by reviewers were compared to AV system. The statistical analysis resulted in a κ value between 0.39 and 0.63 (P < 0.001) and an agreement rate between 79% and 88%. ConclusionsOur improved model can help laboratories design, build, and validate AV systems and be used as starting point for different test groups

Laboratory medicine : a national status report

Although the U.S. ranks highest in per capita health care spending, there is overwhelming evidence of gaps between well-founded standards of care and health care practice. The Institute of Medicine reports, To Err is Human: Building a Safer Health System (1999) and Crossing the Quality Chasm: A New Health System for the 21st Century (2001), and other sentinel studies have focused national attention on improving the quality and safety of health care. Stakeholders agree that the quality of care delivered in the U.S. is inadequate and that the organization and delivery of health care must be improved.Given the shortfalls in quality and continued escalation in costs, health care must be assessed continually to inform decision-making, and redesign delivery and incentives as needed, to yield appropriate, high quality care. An integral component of care is laboratory medicine, which extends across research; screening, diagnosis, and treatment; and public health. Appropriate use of laboratory testing is essential for achieving safe, effective, and efficient care to patients.Health care must be informed by data derived from scientific assessment of efficacy and effectiveness of procedures, and must adapt to ongoing changes in science, technology, and practice. Laboratory medicine is not only responding to these changes, but is contributing to them in an environment of demographic, social, and economic change.The Centers for Disease Control and Prevention (CDC) has commissioned this report to contribute to the groundwork for transforming laboratory medicine over the next decade. CDC charged The Lewin Group, under subcontract to Battelle Memorial Institute, with drafting this document, Laboratory Medicine: A National Status Report. The report examines in detail the key factors affecting the laboratory medicine sector, and is organized into chapters on the following main topics:Value of laboratory medicine\ue2\u20ac\ua2 Market profile of the laboratory medicine sector\ue2\u20ac\ua2 Laboratory medicine workforce\ue2\u20ac\ua2 Quality and the total testing process\ue2\u20ac\ua2 Quality systems and performance measurement\ue2\u20ac\ua2 Laboratory information systems\ue2\u20ac\ua2 Federal regulatory oversight of laboratory medicine\ue2\u20ac\ua2 Reimbursement for laboratory medicinePrepared for: Division of Laboratory Systems, National Center for Preparedness, Detection, and Control of Infectious Diseases, Centers for Disease Control and Prevention; prepared by: The Lewin Group under subcontract to Battelle Memorial Institute.Acknowledgments -- Executive summary -- Introduction -- Methods and limitations -- I. The value of laboratory medicine to health care -- II. Market profile of the laboratory medicine sector -- III. Laboratory medicine workforce -- IV. Quality and the total testing process -- V. Quality systems and performance measurement -- VI. Laboratory information systems -- VII. Federal regulatory oversight of laboratory medicine -- VIII. Reimbursement for laboratory medicine -- Appendix A. Desirable characteristics for performance measures -- Appendix B. Summary of selected performance indicators used by stakeholders -- Appendix C. Development of the Medicare payment system

The organisational and communication implications of electronic ordering systems for hospital pathology services

Computerised Provider Order Entry (CPOE) systems provide clinicians with the ability to electronically enter hospital orders for laboratory tests and services. CPOE is able to integrate with hospital information systems and provide point of care decision support to users thereby making a potentially significant contribution to the efficiency and effectiveness of care delivery. The evidence of the impact of CPOE systems on pathology services is not extensive and insufficient attention has been paid to their effect on organisational and communication processes. This thesis aimed to investigate the implications of CPOE systems for pathology laboratories, their work processes and relationships with other hospital departments, using comparative examinations to identify the tasks they are involved in and the particular needs the laboratories expect to be filled by the new system. This longitudinal study of a CPOE system was carried out over three years using multiple cases from a hospital pathology service based at a large Sydney teaching hospital. Multi-methods using quantitative and qualitative data were employed to achieve triangulation of data, theory and methods. The findings provide evidence of a significant 14.3% reduction of laboratory turnaround times from 42 to 36 minutes when laboratory data for two months were compared before and after CPOE implementation. The findings also reveal changes in the pattern and organisation of information communication, highlighting transformations in the way that work is planned, negotiated and synchronised. These findings are drawn together in a comprehensive organisational communication framework that is highly relevant for developing a contingent and situational understanding of the impact of CPOE on pathology services