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Harmonization of Laboratory Indicators, 09 03-2017
The document discusses harmonization of quality indicators (QIs) in medical laboratories. It notes that while QIs are important for quality improvement, there is currently no consensus on common QIs or how they should be defined and measured. The Working Group on Laboratory Errors and Patient Safety has developed a Model Quality Indicator (MQI) to address this issue, which defines 53 measurements across 27 QIs. Laboratories can now report results to the MQI website voluntarily. Statistical analysis of early participation in the MQI shows the most widely used QIs relate to pre-analytical errors, analytical test performance, and post-analytical issues. However, broader adoption remains a challenge.
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Harmonization of Laboratory Indicators, 09 03-2017
- 1. Harmonization of Laboratory Indicators OlaH. Elgaddar MD, PhD, MBA, CPHQ, LSSGB Lecturer of Chemical Pathology Medical Research Institute Alexandria University [email protected]
- 6. Sources of MedicalErrors ØAvailable data used to focus on medication related errors ØHowever, in recent years, large scale surveys have demonstrated that diagnostic errors are a common occurrence including errors related to laboratory testing
- 8. Quality Indicators (QIs)…... Why? ØAssess and monitor the quality system of the lab…....... ØPromotes and encourages investigations when errors occur….....
- 9. Quality Indicators (QIs)…... Why? ØIdentify strategies and procedures for improvement ØEvaluate lab performance in relation to the State-of-the-Art (i.e. benchmarking)
- 10. Quality Indicators (QIs)…... Why? ØAccording to the ISO 15189:2012, clinical laboratories should identify critical TTP activities and implement QIs in order to highlight and monitor errors when they occur.
- 12. Harmonization Harmonization, in music,is the implementation of harmony, usually by using chords, including harmonized scales
- 13. Harmonization – LabMedicine According to a patient-centered viewpoint, harmonization is that the information should be comparable irrespective of the measurement procedure used and where and/or when a measurement is made.
- 14. Provision of anaccurate and actionable laboratory information
- 15. Harmonization – LabMedicine SCOPE = TTP ØTests and test profiles request ØAnalytical processes and methods ØTerminology ØUnits ØReport formats ØReference intervals ØDecision limits
- 16. Back to Are theyharmonized??
- 17. Unfortunately, there isno consensus on common QIs covering the whole TTP, nor there is an agreement on common terminology or targets!
- 18. Identifying a suitableState-of-the-Art is challenging, because it calls for the knowledge of error rates measured in a variety of laboratories throughout the world that differ in their organization and management, context, and population served
- 19. The Working Group“Laboratory Errors and Patient Safety” (WG-LEPS) of the IFCC has, since 2008, implemented a project aimed at defining a common Model of QIs (MQI), a harmonized method for data collection, managed as an External Quality Assurance Program (EQAP) in which confidentiality is guaranteed
- 21. Preliminary MQI thatwas tested under real conditions by involving laboratories between 2008 & 2013, then the main findings were discussed in the Consensus Conference held in Padua in 2013
- 22. The achieved preliminaryconsensus on terminology, rationale, purpose and procedures of data collection resulted in a preliminary set of reviewed and approved quality indicators issued after the Consensus Conference, and used since 2014
- 23. A new MQIhas been issued after the Consensus Conference of Padua 2016, that includes: Ø 53 measurements to monitor Ø 27 QIs Ø Explanatory notes Ø A priority index has been assigned to each quality indicator (“1” is the higher priority; “4” the lower)
- 24. Indicators and measurements ØDifferentmeasures are often required to ensure that an indicator is appropriately monitored. ØIt is advisable to split an indicator into different measures in order to consider all the events causing a specific error, and to benchmark data entered by different laboratories to avoid misleading comparisons (Ex: In and outpatients)
- 25. All laboratories canuse the new MQI, available in the website, since 2017. The laboratory results are collected on the specifically-developed website (www.ifcc-mqi.com) and managed within an EQAP through which laboratory results are evaluated in comparison to the results of all participating laboratories.
- 26. In order toencourage laboratories to participate in the project, they are not compelled to use all QIs proposed in the model and they can, at least at the beginning, select the most appropriate QIs (chosen from those with “priority 1” assigned) and then, they may eventually introduce and use further QIs.
- 27. A confidential reportis periodically issued for each lab containing the following information for each QI: - Laboratory result; - Sigma value - Trend of the laboratory results and of the sigma values, over time; - Distribution of frequency of laboratory results and of the sigma values.
- 32. Statistical data ofQIs collected in the 2014, 2015 and 2016 (6 months)
- 33. QIs most widelyused: ØPre-analytical phase: a) unsuitable samples and b) misidentified errors ØAnalytical phase: a) unacceptable performance in PT and b) tests with inappropriate IQC performance ØPost-analytical phase: a) incorrect reports issued and b) inappropriate TAT
- 34. QIs most widelyused: For QIs of Outcome Measures and Support Processes, all indicators proposed in MQI appear to be used in a similar fashion, but only by a small number of laboratories.
- 35. Most reported difficulties: ØInadequateparticipation in QI data collection by most labs, attributing this to the ‘excessive’ number of QIs included in the MQI ØDifficulties in data collection, especially when automated collection is unavailable.
- 36. Most reported difficulties: ØDifficultyin meeting the deadline for collecting and entering data in the MQI- dedicated website. Laboratories are more inclined undertake the retrospective collection of data, with trans- mission delayed by months or, in extreme cases, a year.