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Diagnostic Errors and Laboratory Medicine – Causes, Strategies and Research...
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Diagnostic Errors and Laboratory Medicine – Causes, Strategies and Research Methodologies

A special issue of Medicina (ISSN 1648-9144). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: closed (31 August 2021) | Viewed by 16481

Special Issue Editor

Dr. Sollip Kim

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Guest Editor
Department of Laboratory Medicine, Inje University, Ilsan Paik Hospital, Goyang, Korea
Interests: quality indicators; risk management; laboratory medicine; pre-analytical error; patient safety; utilization management; critical differences

Special Issue Information

Dear Colleagues,

Laboratory tests play crucial roles in clinical diagnostic procedures and treatment decision making. Errors occurring during laboratory testing may have adverse consequences for patients, including time loss, increased costs, delays in care, and pain and suffering. The aim of this Special Issue is to highlight the wide-ranging research about the causes, status, strategies, and management of laboratory errors throughout the total laboratory testing process from the manufacturing phase to the post-analytical phase. This will play a vital role in gathering information and improving the landscape for laboratory errors, emphasizing the need for a patient-centered approach to laboratory errors.

Dr. Sollip Kim
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Medicina is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1800 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • quality
  • quality indicator
  • quality control
  • quality improvement
  • patient safety
  • laboratory medicine
  • diagnostic errors
  • brain-to-brain loop
  • laboratory-associated errors
  • extra analytical
  • pre-analytical
  • analytical
  • post-analytical
  • quality indicator
  • error detection
  • error reporting
  • error prevention
  • risk management
  • statistical approach
  • systematical approach

Published Papers (6 papers)

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Research

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13 pages, 1156 KiB  
Article
An Algorithmic Approach Is Superior to the 99th Percentile Upper Reference Limits of High Sensitivity Troponin as a Threshold for Safe Discharge from the Emergency Department
by Taekyung Kang, Gwang Sil Kim, Young Sup Byun, Jongwoo Kim, Sollip Kim, Jeonghyun Chang and Soo Jin Yoo
Medicina 2021, 57(10), 1083; https://doi.org/10.3390/medicina57101083 - 12 Oct 2021
Cited by 1 | Viewed by 1779
Abstract
Background and Objectives: High-sensitivity cardiac troponin I (hs-TnI) is an important indicator of acute myocardial infarction (AMI) among patients presenting with chest discomfort at the emergency department (ED). We aimed to determine a reliable hs-TnI cut-off by comparing various values for a [...] Read more.
Background and Objectives: High-sensitivity cardiac troponin I (hs-TnI) is an important indicator of acute myocardial infarction (AMI) among patients presenting with chest discomfort at the emergency department (ED). We aimed to determine a reliable hs-TnI cut-off by comparing various values for a baseline single measurement and an algorithmic approach. Materials and Methods: We retrospectively reviewed the hs-TnI values of patients who presented to our ED with chest discomfort between June 2019 and June 2020. We evaluated the diagnostic accuracy of AMI with the Beckman Coulter Access hs-TnI assay by comparing the 99th percentile upper reference limits (URLs) based on the manufacturer’s claims, the newly designated URLs in the Korean population, and an algorithmic approach. Results: A total of 1296 patients who underwent hs-TnI testing in the ED were reviewed and 155 (12.0%) were diagnosed with AMI. With a single measurement, a baseline hs-TnI cut-off of 18.4 ng/L showed the best performance for the whole population with a sensitivity of 78.7%, specificity of 95.7%, negative predictive value (NPV) of 97.1%, and positive predictive value (PPV) of 71.3%. An algorithm using baseline and 2–3 h hs-TnI values showed an 100% sensitivity, 97.7% specificity, an NPV of 100%, and a PPV of 90.1%. This algorithm used a cut-off of <4 ng/L for a single measurement 3 h after symptom onset or an initial level of <5 ng/L and a change of <5 ng/L to rule a patient out, and a cut-off of ≥50 ng/L for a single measurement or a change of ≥20 ng/L to rule a patient in. Conclusions: The algorithmic approach using serial measurements could help differentiate AMI patients from patients who could be safely discharged from the ED, ensuring that patients were triaged accurately and did not undergo unnecessary testing. The cut-off values from previous studies in different countries were effective in the Korean population. Full article
(This article belongs to the Special Issue Diagnostic Errors and Laboratory Medicine – Causes, Strategies and Research Methodologies)
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9 pages, 1394 KiB  
Article
Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process
by Jeonghyun Chang, Soo Jin Yoo and Sollip Kim
Medicina 2021, 57(5), 477; https://doi.org/10.3390/medicina57050477 - 11 May 2021
Cited by 5 | Viewed by 2094
Abstract
Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, we [...] Read more.
Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, we would like to develop a sustainable, practical system for continuous total laboratory risk management. Materials and Methods: This study was composed of two phases: the development phase in 2019 and the application phase in 2020. A concept flow diagram for the computerized risk registry and management tool (RRMT) was designed using the failure mode and effects analysis (FMEA) and the failure reporting, analysis, and corrective action system (FRACAS) methods. The failure stage was divided into six according to the testing sequence. We applied laboratory errors to this system over one year in 2020. The risk priority number (RPN) score was calculated by multiplying the severity of the failure mode, frequency (or probability) of occurrence, and detection difficulty. Results: 103 cases were reported to RRMT during one year. Among them, 32 cases (31.1%) were summarized using the FMEA method, and the remaining 71 cases (68.9%) were evaluated using the FRACAS method. There was no failure in the patient registration phase. Chemistry units accounted for the highest proportion of failure with 18 cases (17.5%), while urine test units accounted for the lowest portion of failure with two cases (1.9%). Conclusion: We developed and applied a practical computerized risk-management tool based on FMEA and FRACAS methods for the entire testing process. RRMT was useful to detect, evaluate, and report failures. This system might be a great example of a risk management system optimized for clinical laboratories. Full article
(This article belongs to the Special Issue Diagnostic Errors and Laboratory Medicine – Causes, Strategies and Research Methodologies)
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14 pages, 2250 KiB  
Article
What We Should Consider in Point of Care Blood Glucose Test; Current Quality Management Status of a Single Institution
by Sooin Choi, Soo Jeong Choi, Byung Ryul Jeon, Yong-Wha Lee, Jongwon Oh and You Kyoung Lee
Medicina 2021, 57(3), 238; https://doi.org/10.3390/medicina57030238 - 4 Mar 2021
Cited by 3 | Viewed by 6115
Abstract
Background and Objectives: Point of care test (POCT) is generally performed by non-laboratory staff who often lack an understanding on the quality control and quality assurance programs. The purpose of this study was to understand the current status of quality management of point [...] Read more.
Background and Objectives: Point of care test (POCT) is generally performed by non-laboratory staff who often lack an understanding on the quality control and quality assurance programs. The purpose of this study was to understand the current status of quality management of point of care (POC) blood glucose testing in a single institution where non-laboratory staff perform the tests. Materials and Methods: From July to August 2020, management status of glucometer, test strips, quality control (QC) materials, quality assurance program, and operators’ response to processing of displayed results was monitored in all Soonchunhyang University Bucheon hospital departments that performed POC blood glucose test. Results of the POC blood glucose test conducted from January 2019 to May 2020 were analyzed retrospectively. Results: A total 124 glucometers were monitored in 47 departments. Insufficient management of approximately 50% of blood sugar, test strips, and QC materials was observed. Although daily QC was conducted by 95.7% of the departments, the QC records were inaccurate. The method of recording test results varied with departments and operators. Various judgments and troubleshooting were performed on the unexpected or out of measurable range results, including some inappropriate processes. In POC blood glucose test results review, 4568 atypical results were identified from a total of 572,207 results. Conclusions: Sufficient training of the non-laboratory staff and ongoing assessment of competency through recertification is needed to maintain acceptable levels of POCT quality. In this study, various problems were identified in glucometer and reagent management, QC and post-analytic phase. We believe that these results provide meaningful basal information for planning effective operators’ training and competency evaluation, and the development of an efficient POCT quality management system. Full article
(This article belongs to the Special Issue Diagnostic Errors and Laboratory Medicine – Causes, Strategies and Research Methodologies)
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15 pages, 3770 KiB  
Article
Chronometric vs. Structural Hypercoagulability
by Carmen Delianu, Mihaela Moscalu, Loredana Liliana Hurjui, Claudia Cristina Tărniceriu, Oana-Viola Bădulescu, Ludmila Lozneanu, Ion Hurjui, Ancuta Goriuc, Zinovia Surlari and Liliana Foia
Medicina 2021, 57(1), 13; https://doi.org/10.3390/medicina57010013 - 28 Dec 2020
Cited by 1 | Viewed by 1673
Abstract
Prolonged tourniquet stasis induced by venepuncture can lead to the release of the plasma of cell lysis products, as well as tissue factor (TF), impairing the quality of coagulation test results. The accidental presence of TF in vitro can trigger the coagulation mechanism, [...] Read more.
Prolonged tourniquet stasis induced by venepuncture can lead to the release of the plasma of cell lysis products, as well as tissue factor (TF), impairing the quality of coagulation test results. The accidental presence of TF in vitro can trigger the coagulation mechanism, generating a false decrease in prothrombin time (PT). Background and Objectives: Identification of short PT tests below the normal reference value that could suggest a situation of hypercoagulability. The study aimed to compare the results of the shortened PT tests at their first determination with the eventual correction following duplication of the analysis from the same sample. Materials and methods: Identification of the shortened PT tests has been carried out for a period of 4 months, upon 544 coagulation samples referred to the Hematology department of Sf. Spiridon County Clinical Emergency Hospital from Iasi, Romania. Results: Out of the 544 samples of which the results indicated a state of hypercoagulability, by repeating the determination from the same sample, for 200 (36.76%) PT tests (p = 0.001) the value was corrected, falling within the normal reference range. For 344 (63.24%) tests, the results suggested a situation of hypercoagulability. Conclusions: In order to guarantee the highest quality of the laboratory services, a proper interpretation and report of the patients’ results must be congruent and harmoniously associated to the actual clinical condition of the patient. Duplication of the PT determination from the same sample would exclude situations of false hypercoagulability and would provide significant improvement for the patient’s safety. Full article
(This article belongs to the Special Issue Diagnostic Errors and Laboratory Medicine – Causes, Strategies and Research Methodologies)
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9 pages, 653 KiB  
Article
Importance of Susceptibility Rate of ‘the First’ Isolate: Evidence of Real-World Data
by Sollip Kim, Soo Jin Yoo and Jeonghyun Chang
Medicina 2020, 56(10), 507; https://doi.org/10.3390/medicina56100507 - 28 Sep 2020
Cited by 5 | Viewed by 1757
Abstract
Background and objectives: For proper antimicrobial therapy, cumulative antibiograms should be representative of geographic region and be accurate. Clinical and Laboratory Standards Institute (CLSI) guidelines recommend that only the first isolates (FI) of a species per patient are used when reporting cumulative antibiograms. [...] Read more.
Background and objectives: For proper antimicrobial therapy, cumulative antibiograms should be representative of geographic region and be accurate. Clinical and Laboratory Standards Institute (CLSI) guidelines recommend that only the first isolates (FI) of a species per patient are used when reporting cumulative antibiograms. However, >50% of hospitals in the United States report antibiograms of all isolates. We compared antibiograms from the FI with those from total isolates (TI). Materials and Methods: Antimicrobial data of all isolates identified in the Microbiology unit of Ilsan Paik Hospital in 2019 were retrospectively acquired from the hospital information system. The susceptibility rates to antimicrobials of Escherichia coli, Acinetobacter baumannii, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, Enterococcus faecium, and Enterococcus faecalis were analyzed by FI and TI, respectively. Isolate counts and susceptibility rates of each species for the reported antimicrobials were compared. Results: The numbers of isolates by FI/TI were as follows: 1824/2692 E. coli, 480/1611 A. baumannii, and 662/1306 K. pneumoniae, and 407/953 P. aeruginosa for gram-negative bacteria and 649/1364 S. aureus, 211/313 E. faecium, and 323/394 E. faecalis for gram-positive bacteria. All antimicrobial agents showed higher susceptibility rates when calculated as FI than as TI in gram-negative bacteria except colistin: 3.7% for E. coli, 14.5% for A. baumannii, 8.3% for K. pneumoniae, and 7.9% for P. aeruginosa. In S. aureus, 8/11 antimicrobial agents revealed higher susceptibility rates for FI than for TI. E. faecalis and E. faecium showed lower susceptibility rates for 7/10 antimicrobial agents for FI than for TI. The oxacillin susceptibility rates of S. aureus were 36.6%/30.2% with FI/TI and vancomycin susceptibility rates for E. faecium were 54.1% and 49.5%, respectively. Conclusions: When comparing cumulative antibiograms by FI with TI using real-world data, there is a large gap for critical species requiring hospital infection control. Although FI calculation is difficult, antibiograms must be calculated as FI for proper preemptive antimicrobial therapy because FI provides proper antimicrobial susceptibility data. Full article
(This article belongs to the Special Issue Diagnostic Errors and Laboratory Medicine – Causes, Strategies and Research Methodologies)
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Review

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11 pages, 930 KiB  
Review
The Application of Control Materials for Ongoing Quality Management of Next-Generation Sequencing in a Clinical Genetic Laboratory
by Young-Kyu Min and Kyung-Sun Park
Medicina 2021, 57(6), 543; https://doi.org/10.3390/medicina57060543 - 28 May 2021
Cited by 1 | Viewed by 2353
Abstract
Next-generation sequencing (NGS) has played an important role in detecting genetic variants with pathologic and therapeutic potential. The advantages of NGS, such as high-throughput sequencing capacity and massively parallel sequencing, have a significant impact on realization of genetic profiling in clinical genetic laboratories. [...] Read more.
Next-generation sequencing (NGS) has played an important role in detecting genetic variants with pathologic and therapeutic potential. The advantages of NGS, such as high-throughput sequencing capacity and massively parallel sequencing, have a significant impact on realization of genetic profiling in clinical genetic laboratories. These changes have enabled clinicians to execute precision medicine in diagnosis, prognosis, and treatment for patients. However, to adapt targeted gene panels in diagnostic use, analytical validation and ongoing quality control should be implemented and applied with both practical guidelines and appropriate control materials. Several guidelines for NGS quality control recommend usage of control materials such as HapMap cell lines, synthetic DNA fragments, and genetically characterized cell lines; however, specifications or applications of such usage are insufficient to guideline method development. This review focuses on what factors should be considered before control material selection for NGS assay and practical methods of how they could be developed in clinical genetic laboratories. This review also provides the detailed sources of critical information related to control materials. Full article
(This article belongs to the Special Issue Diagnostic Errors and Laboratory Medicine – Causes, Strategies and Research Methodologies)
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