What’s to Be Done About Laboratory Quality? Process Indicators, Laboratory Stewardship, the Outcomes Problem, Risk Assessment, and Economic Value

Meier, Frederick A.; Badrick, Tony; Sikaris, Kenneth A

doi:10.1093/ajcp/aqx135

Cited by 10 publications

(15 citation statements)

References 45 publications

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“…Failure mode and effects analysis is now a recognized process analysis tool and widely used in industry, government and medical process improvement methods. It was first used in the health industry in the 1990s and provided an indirect connection between error (or incident), causes and harm (or poor patient outcomes) (5,6). This paper aims to review the data submitted to the KIMMS program to see whether the number of errors with a higher RPN have been reduced in preference to those with a lower RPN, and to calculate the cost of these errors.…”

Section: Gay S Badrick Tmentioning

confidence: 99%

Changes in error rates in the Australian key incident monitoring and management system program

Badrick

2020

Biochem. med. (Online)

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Introduction: The Key incident monitoring and management system program (KIMMS) program collects data for 19 quality indicators (QIs) from Australian medical laboratories. This paper aims to review the data submitted to see whether the number of errors with a higher risk priority number (RPN) have been reduced in preference to those with a lower RPN, and to calculate the cost of these errors. Materials and methods: Data for QIs from 60 laboratories collected through the KIMMS program from 2015 until 2018 were retrospectively reviewed. The results for each QI were averaged for the four-year average and coefficient of variation. To review the changes in QI frequency, the yearly averages for 2015 and 2018 were compared. By dividing the total RPN by 4 and multiplying that number by the cost of recollection of 30 AUD, it was possible to assign the risk cost of these errors. Results: The analysis showed a drop in the overall frequency of incidents (6.5%), but a larger drop in risk (9.4%) over the period investigated. Recollections per year in Australia cost the healthcare industry 27 million AUD. If the RPN data is used, this cost increases to 66 million AUD per year. Conclusions: Errors with a higher RPN have fallen more than those with lower RPN. The data shows that the errors associated with phlebotomy are the ones that have most improved. Further improvements require a better understanding of the root cause of the errors and to achieve this, work is required in the collection of the data to establish best-practice guidelines.

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Section: Gay S Badrick Tmentioning

confidence: 99%

Changes in error rates in the Australian key incident monitoring and management system program

Badrick

2020

Biochem. med. (Online)

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“…In the last years, however, several research lines emphasized some fundamental issues to provide better laboratory services. First, laboratory process quality should begin and end "outside the laboratory", extending quality measurement to steps in the total testing process antecedent to the analytical step (pre-pre-analytical phase) and subsequent to result reporting (post-post-analytical phase) [30,31]. Second, appropriate stewardship of laboratory resources may improve patient care by ensuring the correct tests are performed at the appropriate time while unnecessary tests are avoided.…”

Section: Toward An Outcome-based Evaluation Of Clinical Laboratory Sementioning

confidence: 99%

Clinical laboratory: bigger is not always better

Plebani

2018

Diagnosis

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Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on expectations to improve efficiency, increasing volumes and reducing the cost per test. However, the relationship between volume and costs is not linear and numerous variables influence the end cost per test. In particular, the relationship between volumes and costs does not span the entire platter of clinical laboratories: high costs are associated with low volumes up to a threshold of 1 million test per year. Over this threshold, there is no linear association between volumes and costs, as laboratory organization rather than test volume more significantly affects the final costs. Currently, data on laboratory errors and associated diagnostic errors and risk for patient harm emphasize the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. Process and outcome quality indicators are effective tools to measure and improve laboratory services, by stimulating a competition based on intra- and extra-analytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.

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“…Detection of these errors requires reliable quality indicators during the total testing process (TTP), from the time the laboratory request is determined, until the clinician receives the final report, makes a diagnosis and decides on the appropriate action [3,5,6]. Launched in 2008, the Key Incident Monitoring and Management System (KIMMS) is an Australasian-developed quality improvement (QI) program that records incidents (process defects) and episodes (occasions where incidents may occur) while also assigning quantified risk to each incident type (by multiplying by harm rating and detection difficulty score) using failure mode effects analysis (FMEA) [5]. By 2016 KIMMS had detected over 200 million episodes and 2.9 million incidents, detecting an overall TTP incident rate of 1.75% [5].…”

Section: Introductionmentioning

confidence: 99%

“…Launched in 2008, the Key Incident Monitoring and Management System (KIMMS) is an Australasian-developed quality improvement (QI) program that records incidents (process defects) and episodes (occasions where incidents may occur) while also assigning quantified risk to each incident type (by multiplying by harm rating and detection difficulty score) using failure mode effects analysis (FMEA) [5]. By 2016 KIMMS had detected over 200 million episodes and 2.9 million incidents, detecting an overall TTP incident rate of 1.75% [5]. Some incident rates may appear low, but when taking into account risks and their frequencies, critical incident types emerge that require improvements in management.…”

Section: Introductionmentioning

confidence: 99%

“…"sample suspected to be from wrong patient" had the second lowest score) but high harm rating (e.g. 10/10) and detection difficulty scores (10/10) end up having a relatively higher risk to reflect the severity of potential risk to the patient [5]. Until recently, KIMMS has focused mainly on the pre-laboratory phase of the TTP cycle, thus there has been a need to create an EQA program that encompasses the post-laboratory phase.…”

Section: Introductionmentioning

confidence: 99%

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Informatics External Quality Assurance (IEQA) Down Under: evaluation of a pilot implementation

Hardie

Moore

Holzhauser

et al. 2018

LaboratoriumsMedizin

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External quality assurance (EQA) provides ongoing evaluation to verify that laboratory medicine results conform to quality standards expected for patient care. While attention has focused predominantly on test accuracy, the diagnostic phases, consisting of pre- and post-laboratory phases of testing, have thus far lagged in the development of an appropriate diagnostic-phase EQA program. One of the challenges faced by Australian EQA has been a lack of standardisation or “harmonisation” resulting from variations in reporting between different laboratory medicine providers. This may introduce interpretation errors and misunderstanding of results by clinicians, resulting in a threat to patient safety. While initiatives such as the Australian Pathology Information, Terminology and Units Standardisation (PITUS) program have produced Standards for Pathology Informatics in Australia (SPIA), conformity to these requires regular monitoring to maintain integrity of data between sending (laboratory medicine providers) and receiving (physicians, MyHealth Record, registries) organisations’ systems. The PITUS 16 Informatics EQA (IEQA) Project together with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) has created a system to perform quality assurance on the electronic laboratory message when the laboratory sends a result back to the EQA provider. The purpose of this study was to perform a small scale pilot implementation of an IEQA protocol, which was performed to test the suitability of the system to check compliance of existing Health Level-7 (HL7 v2.4) reporting standards localised and constrained by the RCPA SPIA. Here, we present key milestones from the implementation, including: (1) software development, (2) installation, and verification of the system and communication services, (3) implementation of the IEQA program and compliance testing of the received HL7 v2.4 report messages, (4) compilation of a draft Informatics Program Survey Report for each laboratory and (5) review consisting of presentation of a report showing the compliance checking tool to each participating laboratory.

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What’s to Be Done About Laboratory Quality? Process Indicators, Laboratory Stewardship, the Outcomes Problem, Risk Assessment, and Economic Value

Cited by 10 publications

References 45 publications

Changes in error rates in the Australian key incident monitoring and management system program

Changes in error rates in the Australian key incident monitoring and management system program

Clinical laboratory: bigger is not always better

Informatics External Quality Assurance (IEQA) Down Under: evaluation of a pilot implementation

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