Risk assessment of the total testing process based on quality indicators with the Sigma metrics
-
Yong Xia
and
Ling Ji
Abstract
Background
Evidence-based evaluation of laboratory performances including pre-analytical, analytical and post-analytical stages of the total testing process (TTP) is crucial to ensure patients receiving safe, efficient and effective care. To conduct risk assessment, quality management tools such as Failure Mode and Effect Analysis (FMEA) and the Failure Reporting and Corrective Action System (FRACAS) were constantly used for proactive or reactive analysis, respectively. However, FMEA and FRACAS faced big challenges in determining the scoring scales and failure prioritization in the assessment of real-world cases. Here, we developed a novel strategy, by incorporating Sigma metrics into risk assessment based on quality indicators (QIs) data, to provide a more objective assessment of risks in TTP.
Methods
QI data was collected for 1 year and FRACAS was applied to produce the risk rating based on three variables: (1) Sigma metrics for the frequency of defects; (2) possible consequence; (3) detection method. The risk priority number (RPN) of each QI was calculated by a 5-point scale score, where a value of RPN > 50 was rated as high-risk.
Results
The RPNs of two QIs in post-analytical phase (TAT of Stat biochemistry analyte and Timely critical values notification) were above 50 which required rigorous monitoring and corrective actions to eliminate the high risks. Nine QIs (RPNs between 25 and 50) required further investigation and monitoring. After 3 months of corrective action the two identified high-risk processes were successfully reduced.
Conclusions
The strategy can be implemented to reduce identified risk and assuring patient safety.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: Thanks to Bin Shen, Zhisheng Tan and Yuefeng Zhou of BD China for their professional support in the pre-analysis QIs analysis and risk assessment.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2020 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorial
- Quality controls for serology: an unfinished agenda
- A modern and pragmatic definition of Laboratory Medicine
- Reviews
- Blood biochemical characteristics of patients with coronavirus disease 2019 (COVID-19): a systemic review and meta-analysis
- ISO/TS 20914:2019 – a critical commentary
- Mini Review
- Reporting of D-dimer data in COVID-19: some confusion and potential for misinformation
- Opinion Paper
- Implementation of metrological traceability in laboratory medicine: where we are and what is missing
- IFCC Recommendation
- Recommendation for performance verification of patient-based real-time quality control
- Genetics and Molecular Diagnostics
- Comparison of BCR-ABL1 quantification in peripheral blood and bone marrow using an International Scale-standardized assay for assessment of deep molecular response in chronic myeloid leukemia
- General Clinical Chemistry and Laboratory Medicine
- Risk assessment of the total testing process based on quality indicators with the Sigma metrics
- Determination of hemolysis cut-offs for biochemical and immunochemical analytes according to their value
- A computer model for professional competence assessment according to ISO 15189
- Traceability validation of six enzyme measurements on the Abbott Alinity c analytical system
- Evaluating the need for free glycerol blanking for serum triglyceride measurements at Charlotte Maxeke Johannesburg Academic Hospital
- Challenges of LC-MS/MS ethyl glucuronide analysis in abstinence monitoring of liver transplant candidates
- Changes in the result of antinuclear antibody immunofluorescence assay on HEp-2 cells reflect disease activity status in systemic lupus erythematosus
- Reference Values and Biological Variations
- Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects
- Age-specific reference values improve the diagnostic performance of AMH in polycystic ovary syndrome
- Establishment of reference intervals for immunoassay analytes of adult population in Saudi Arabia
- Hematology and Coagulation
- Total haemoglobin – a reference measuring system for improvement of standardisation
- Laboratory testing for activated protein C resistance: rivaroxaban induced interference and a comparative evaluation of andexanet alfa and DOAC Stop to neutralise interference
- Cancer Diagnostics
- Identification of a four-gene methylation biomarker panel in high-grade serous ovarian carcinoma
- Performance comparison of two next-generation sequencing panels to detect actionable mutations in cell-free DNA in cancer patients
- Diabetes
- Availability and analytical quality of hemoglobin A1c point-of-care testing in general practitioners’ offices are associated with better glycemic control in type 2 diabetes
- Infectious Diseases
- Validation of a chemiluminescent assay for specific SARS-CoV-2 antibody
- Dynamic profile and clinical implications of hematological parameters in hospitalized patients with coronavirus disease 2019
- Does a change in quality control results influence the sensitivity of an anti-HCV test?
- Letters to the Editor
- Variability between testing methods for SARS-CoV-2 nucleic acid detection 16 days post-discharge: a case report
- L-index, more than a screening tool for hypertriglyceridemia
- Neutralization of biotin interference: preliminary evaluation of the VeraTest Biotin™, VeraPrep Biotin™ and BioT-Filter®
- Counting and reporting band count is unreliable practice due to the high inter-observer variability
- Cigarette smoking prior to blood sampling acutely affects serum levels of the chronic obstructive pulmonary disease biomarker surfactant protein D
- How reliable is the detection of anti-mitochondrial antibodies on murine triple-tissue?
- Further advices on measuring lipoprotein(a) for reducing the residual cardiovascular risk on statin therapy
