Implementation and validation of an intelligent auto-verification system in a coagulation testing automatic line.

Objective To establish a set of rules for autoverification of blood analysis, in order to provide a way to validate autoverification rules for different analytical systems, which can ensure the accuracy of test results as well as shorten turnaround time (TAT) of test reports. Methods A total of 34 629 EDTA-K2 anticoagulated blood samples were collected from multicenter cooperative units including the First Hospital of Jinlin University during January 2017 to November 2017. These samples included: 3 478 cases in Autoverification Establishment Group, including 288 cases for Delta check rules; 5 362 cases in Autoverification Validation Group, including 2 494 cases for Delta check; 25 789 cases in Clinical Application Trial Group. All these samples were analyzed for blood routine tests using Sysmex XN series automatic blood analyzers.Blood smears, staining and microscopic examination were done for each sample; then the clinical information, instrument parameters, test results and microscopic results were summarized; screening and determination of autoverification conditions including parameters and cutoff values were done using statistical analysis. The autoverification rules were input into Sysmex Laboman software and undergone stage Ⅰ validation using simulated data, and stage Ⅱ validation for post-analytical samples successively. True negative, false negative, true positive, false positive, autoverification pass rate and passing accuracy were calculated. Autoverification rules were applied to autoverification blood routine results and missed detection rates were validated, and also data of autoverification pass rate and TAT were obtained. Results (1)The selected autoverification conditions and cutoff values included 43 rules involving WBC, RBC, PLT, Delta check and abnormal characteristics. (2)Validation of 3 190 cases in Autoverification Establishment Group showed the false negative rate was 1.94%(62/3 190)(P<0.001), autoverification pass rate was 76.74%, passing accuracy was 97.47%; Validation of 2 868 cases in Autoverification Validation Group, the false negative rate was 3.38%(97/2 868)(P=0.002), autoverification pass rate was 42.26%, passing accuracy was 92.00%; Validation of Delta check on 288 cases in Autoverification Establishment Group and 2 494 cases in Autoverification Validation Group showed the false negative rates were respectively 1.39% and 2.61%(P<0.001). (3)Three hospitals adopted these rules of autoverification for 25 789 blood routine samples, and found that the average TAT of blood routine test reports were shortened by 24min, 32min and 7min respectively, the rate of samples reported within 30min were elevated by 33%, 53% and 7%. The autoverification pass rates were 72%-74%. Conclusions The application of this set of 43 autoverification rules in blood sample analysis can ensure test quality while shortenTAT and improve work efficiency. It is worth pointing out that for the same analytical systems in this research, validation is necessary before application of this set of rules, and periodic validation is required during application to make necessary adjustment; for different analytical systems, as this research provide a way to establish autoverification rules for blood routine tests.Clinical labs may establish their own suitable autoverification rules on the basis of technological parameters. (Chin J Lab Med, 2018, 41: 601-607) Key words: Autoverification rules; Blood analysis; Validation; Turnaround time; Miss rate

A multicenter study for establishment and evaluation of auto-verification rules for routine coagulation tests

Hematology analysis is a common test among patients in hospital. However, manual verification of hematology analysis is time consuming and tedious, with variation between inter-individual laboratory workers. This study was to establish and validate a set of autoverification rules for hematology analysis in the department of laboratory medicine, Zhongshan Hospital of Sun Yatsen University. Hematology analysis was measured by a Sysmex XN-9000 hematology system in the Department of Laboratory Medicine, Zhongshan Hospital of Sun Yatsen University. SYSMEX Laboman EasyAccess 6.0 and the laboratory information system were used to construct the algorithm and design the autoverification rules of hematology analysis according to Clinical and Laboratory Standards Institute document Auto 10A and 41 rules of Hematology Review Criteria. The laboratory turnaround time (TAT), autoverification pass rates, false positive, false negative, and the average error rate were verified after implementing autoverification rules. Approximate 1,300 specimens were collected daily and transferred to our laboratory for hematology analysis; that is necessary to build a database and to design autoverification rules. The average autoverification passing rate was 81%; the false positive rate was 13.6%; the false negative rate and the average error rate was nearly zero, indicating that incorrect reports were almost eliminated. Moreover, since implementing autoverification, the TAT was reduced by 27.0% in in-patient reports, by 21.9% in out-patient reports, and by 39.0% in emergency reports, which enhanced the productivity in our laboratory. Our laboratory accelerated verification and decreased TAT and the odds of human review errors in the released results since implementing the autoverification. Thus, we can save more time and concentrate on verifying the abnormal results and processing emergency tests.

Real-time dashboards: Quality control for pharmacy practice

Autoverification is a process of using computer-based rules to verify clinical laboratory test results without manual review. But to date, there are few published articles on the use of autoverification over the course of years in a clinical laboratory. In our study, we firstly described the development and implementation of autoverification rules for enzyme-linked immunosorbent assay (ELISA) results of hepatitis B virus (HBV) serological markers in a clinical immunology laboratory. We designed the autoverification rules for HBV by using Boolean logic on five clinically used serological markers in accordance with the framework of AUTO-10A, issued by the American Clinical Laboratory Standards Institute in 2006. The rules were written into the laboratory information system (LIS) and installed in the computer, so we could use the LIS to screen the test results. If the results passed the autoverification rules, they could be sent to doctors immediately. To evaluate the autoverification rules, we applied the real-time data of 11,585 patients with the autoverification rules. The autoverification rate of the five HBV serological markers was 79.5%. Furthermore, the turnaround time (TAT) was reduced by 38% (78 minutes vs. 126 minutes). The error rate was nearly eliminated. These results show that using LIS with autoverification rules can shorten TAT, enhance efficiency, and reduce manual review errors.

Objective Use the self-developed all-factor intelligent auditing platform in the KMClient laboratory information system to release a large number of inspection reports, the automatic auditing and early warning rules of items are set up in biochemical luminescence, clinical blood, clinical immunology, mass spectrometry, microorganism, gene and pathology and a large number of inspection reports originally required to be issued by manual auditing are submitted to the computer for publication, thus reduce the number of people and the error of the report result caused by manual error, reduce the sample turn around time (TAT), save labor costs and improve work efficiency. Methods According to the technical requirements and industry standards of biochemical luminescence, clinical blood, clinical immunology, clinical microbiology, gene and pathology, several autoverification rules are set up respectively to judge the results. The results can be released by computer if judgement is passed, otherwise the results will be intercepted and released by manual verification statistical regularly on the status of automatic audit approval of each test item, and gradually optimize the early warning rules, compare the TAT changes before and after the use of automatic audit function and the number changes of report approval personnel to evaluate the effectiveness of automatic audit. Results After the use of the automatic audit in all disciplines of the laboratory, the accuracy and timeliness of the report have been significantly improved. The average TAT in each department has been shortened by 0.5 h and the total number of staffs has been reduced by 4, and the defect rate of the report defect rate has been reduced by 80%. Conclusion The all-factor intelligent auditing platform developed by our center can meet the needs of many disciplines, and is superior to most of the automatic audit middleware in the market. The use of automatic audit can not only further improve the efficiency of laboratory work and shorten TAT, but also reduce the quality defects caused by human factors, and maintain the quality assurance of laboratory analysis. Key words: Comprehensive; Intelligence autoverification; Warning rules; Efficacy evaluation

Background: In recent times, growing coagulation test volume and constricted personnel budgets have enhanced interest in automated coagulation analyzers. Objective: (i) To compare the reliability of routine coagulation test [prothrombin time (PT) and activated partial thromboplastin time (APTT)] using mechanical, photo-optical, and nephelemetric methods by three automated coagulation analyzers. (ii) To evaluate the performance of a newly installed fully automatic coagulation analyzer [STA Compact Max (Stago)] and compare the consistency of its testing results with the confirmed clinical automatic coagulation analyzer at our department (Sysmex and ACL Top). Materials and Methods: Trisodium citrated (3.2%) 60 blood samples, which came to special (coagulation) laboratory with request of PT and APTT (with or without anticoagulant, abnormal, and normal/controls), Transfusion Medicine and Immunohematology Department, Christian Medical College, Vellore, Tamil Nadu, India, were included into study randomly. Sample were run on Sysmex CS2000i (Sysmex Corporation, Japan), photo-optical clot detection; ACL Top (Instrumentation Laboratory, USA), nephelometry clot detection method; and STA Compact Max (Stago, USA), viscosity-based (mechanical) clot detection. Result: Correlation was determined using Bland and Altman analysis, which demonstrated a good agreement between Sysmex CS2000i, ACL Top, and STA Compact Max for PT and APTT. A total of 10 samples (16.7%) with visually observed interferences were identified and tested on all three analyzers and showed good agreement with optical and mechanical methods. Conclusion: This study showed good agreement between newly installed STA Compact Max based on mechanical endpoint detection method with already standardized Sysmex CS 2000i and ACL Top, which work on photo-optical endpoint detection method, for evaluation of screening coagulation tests such as PT and APTT even in case of variables such as partially lysed/icteric samples. Three automated analyzers can be used interchangeably.

Purpose Following the analytical phase, the current practice of many hospital laboratories involves the manual verification of all test results followed by the production of the report. However, manual verification is a time-consuming and tedious process. In this paper, we provide a detailed description of how to design autoverification rules for thyroid function test profiles and sex hormones. Materials and methods We used DM2 (Data manager 2) to construct the algorithm and build the database for autoverification of thyroid function test profiles and sex hormones, with reference to Boolean logic, Auto 10-A and CLSI'88. The rules consist of checking quality control, instrument error flags, critical values, the analytical measurement range (AMR), the limit range, consistency check and delta check. Firstly, we established the rules in the DM2, collected clinical specimens for validation, then tested the rules in a 'live' environment. Results Agreement was achieved between manual verification by two senior laboratory personnel and verification using the autoverification rules in 99.78% of the cases. The total autoverification rate for all tests was 77.06%. Following implementation of the rules, the laboratory turnaround time (TAT) was reduced by 54.55% and staffing numbers fell from three to two whole time equivalents (WTE). Statistical analysis resulted in a kappa statistic of 0.99 ( P < 0.001). Moreover, after implementing the autoverification rules, the error rate fell to 0.04%, indicating that errors were almost completely eliminated. Conclusion Implementing autoverification rules can reduce TAT, minimize the number of samples that require manual verification and allow for a reduction in staffing numbers. It also allows laboratory staff to devote more time and effort to the handling of problematic test results and contributing to improved patient care.

Multiple pre- and post-analytical lean approaches to the improvement of the laboratory turnaround time in a large core laboratory

Various coagulation tests like Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) are estimated by automated coagulation analyzers. The newer fully automated analyzers generate clot wave forms aPTT-CWA for these parameters are derived. In this study, the objective was to analyze clot wave form characteristics morphology and its first and second derivative values in cases with abnormal APTT. ACL TOP 300 generated curves for APTT in a total 125 patients with 20 normal controls are included. First derivative, second derivative, morphology of curve: sigmoid, biphasic, prolonged pre-coagulation phase, second derivative morphology like early and late shoulder, biphasic peak, delayed deceleration were the analyzed parameters. Wave clot forms of 125 patients were included in this study. Patients (M:F - 2.2:1, mean age: 46.9 ± 20 years). A spectrum of clinical conditions was Covid (20%), liver disease (23%), polytrauma (10.4%), cardiac diseases (8.8%), sepsis/DIC (7.2%), thromboembolism (7.2%), renal diseases (6.4%), bacterial infections (4%), dengue (4%), snake bite (1.6%) and factor deficiency (1.6%). Liver and heart disease showed a significant difference in acceleration and deceleration peaks followed by sepsis, dengue, polytrauma and sepsis/DIC. Deceleration peak was prolonged in patients of Covid (p&lt;0.05). Sepsis and liver diseases showed prolonged first derivative peak (p&lt;0.05). CWA is very easily available on all automated coagulation analyzers. It is inexpensive with fast turn round time. Both quantitative as well as qualitative informations such as velocity, acceleration of clot formation and wave pattern details were recorded. Our study highlights importance of quantitative and qualitative CWA parameters acquired by performing APTT test for the automated analyzers.

To investigate the benefits and challenges of introducing next generation chemistry and coagulation automation. We replaced the Roche modular preanalytic system attached to Roche Cobas 6000 analyzers with the Roche 8100 preanalytical line attached to the Roche Cobas 8000 and Stago STA R Max analyzers. The system included 2 add-on buffers (AOBs) for automated specimen archival and retrieval and primary-tube specimen processing. We measured turnaround time (TAT) from specimen receipt to result for chemistry and coagulation tests before, during, and after system implementation. TAT for add-on tests was also measured. We completed the system implementation during a 17-month period using existing laboratory space. The TAT for chemistry, coagulation, and add-on tests decreased significantly (P <.005, P <.001, and P <.005, respectively). We encountered several challenges, including barcode-label errors, mechanical problems, and workflow issues due to lack of bidirectional track for coagulation testing. Next generation laboratory automation yielded significantly shortened and less-variable TAT, particularly for add-on testing. Our approach could help other laboratories in the process of implementing and configuring automated systems.

Establishing and Evaluating Autoverification Rules with Intelligent Guidelines for Arterial Blood Gas Analysis in a Clinical Laboratory.

Accuracy of Real-time Couch Tracking During 3-dimensional Conformal Radiation Therapy, Intensity Modulated Radiation Therapy, and Volumetric Modulated Arc Therapy for Prostate Cancer

To develop an automated verification workflow for transfusion compatibility testing (TCT) based on the AUTO10-A guidelines and blood group serology characteristics and to conduct a simulated validation of the test and subtest results by assessing the appropriateness of the autoverification rules. The accuracy of TCT results is a fundamental prerequisite for ensuring the safety of blood transfusions. However, the verification of these results still requires manual intervention. Five autoverification rules and their standards were determined: agglutination intensity, normal results, logical relationships, delta checks and interlaboratory test comparisons. The established categories and standards for the five rules were retrospectively validated using 13 506 samples (requests) that had been manually verified in our laboratory from January 2020 to June 2023. A total of 66 638 test items were involved in the autoverification, with 3844 items violating the verification rules, resulting in a pass rate of 96.10%. Considering individual test items, four tests had a pass rate of more than 90% in both the test item result table and the test subitem result table. However, there were significant differences in the pass rates between different tests. The same conclusion can be drawn when the unit is requests. The different standards set for the agglutination intensity and the delta check in the ABO typing testing subitems showed significant differences in pass rates. The incorporation of manually verified results into the automated verification simulation indicated that the five rules established in this study have good applicability, and appropriate standards can lead to reasonable pass rates.

Introduction Intravenous lipid emulsion is used in the rescue treatment of certain poisonings. A complication is interference with laboratory analyses. The aim of this study was to determine the impact of intravenous lipid emulsion on routine laboratory analysis of coagulation parameters ex vivo and determine if any of the analytical techniques remain reliable. Methods Samples were obtained from 19 healthy volunteers and divided in triplicate. One sample served as a control, and the other two were diluted to simulate the treatment of an average adult with Intralipid® 20 per cent Fresenius Kabi 100 mL (dilution-1) or 500 mL (dilution-2). Coagulation tests performed were prothrombin time, activated prothrombin time, D-dimer concentration and fibrinogen. Coagulation testing was performed by three techniques. Test-1 was performed on a Sysmex CN6000 analyzer. Test-2 was performed with a manual mechanical endpoint method using the semi-automated Stago KC4 Delta. Test-3 involved high-speed centrifugation before repeat testing on the Sysmex CN6000 analyzer. Results For test-1, only nine (47 per cent) samples in dilution-1 could be analyzed for coagulation tests, and no coagulation tests could be analyzed for dilution-2 because of lipaemia. For test-2 and test-3, all samples could be analyzed, and all results of both testing methods fell within the limits of the laboratory reference range. Discussion Difficulties in laboratory analysis of patients having received intravenous lipid emulsion are due to multiple factors. Most automated coagulation analyzers use optical measurements, which can be unreliable in the presence of a high intravenous lipid concentration. By altering the lipaemia in the testing solution using high-speed centrifugation or by using manual mechanical endpoint detection, we were able to obtain reliable results. These findings are limited by the use of an ex vivo method and healthy volunteers. Conclusions This ex vivo model confirms that Intralipid® interferes with routine coagulation studies. It is important that clinicians are aware and inform their laboratories of its administration.