Electronic data management for the Hemochron Jr. Signature coagulation analyzer.
ABSTRACT Point-of-care testing (POC, POCT) laboratory devices are being introduced into operating suites and critical care units in ever increasing numbers. The small, portable devices have gained in popularity because of their ease of use and the rapid availability of test results. POCT is an integral part of extracorporeal technology (ECT). A challenge associated with the growth of POC technology is related to management of the data generated by these devices. In the field of ECT, storing, retrieving, analyzing, viewing and charting quality control (QC) and patient test data generated with POC coagulation instruments is essential. We evaluated a premarket version of data management software developed for the Hemochron Jr. Signature coagulation analyzer, a PC-based software capable of fulfilling our objective. A database comprised of greater than 50 plasma and electronic QC results and greater than 140 patient sample results for ACT, PT, and aPTT tests was transferred from a Hemochron Jr. Signature device to two different PCs, each equipped with Hemochron ReportMaker software supplied by the manufacturer. Data files were transferred directly from the coagulation test unit to the PCs via an RS-232 cable. A variety of charts, reports, and file listings were created from the datasets using the software menus. Transfer of the complete database required less than 5 min. The relative speed and simplicity of the data interface promotes frequent charting of QC data, permitting real-time monitoring and early identification of data trends or values requiring intervention. If a subset of QC data is found to be incomplete, altered, or unacceptable, all patient samples tested during that period can be promptly identified. The software also includes data query tools useful for sorting and selecting specific subsets of patient and QC data. Electronic data management can facilitate compliance with quality control requirements and assist clinicians and laboratory personnel in the collection, storage, and review of quality control and patient test data. In addition, the patient and QC data are readily accessible when necessary for use in risk management assessment, accreditation, or litigation proceedings.
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ABSTRACT: To establish the effect of a quality control failure on the performance of the LCx-GC nucleic-acid amplification assay for Neisseria gonorrhoeae (Abbott Laboratories, Abbott Park, IL) in the field, we conducted a retrospective analysis comparing the clinical and analytic performance of the recalled lots with those not implicated in the recall. Our analysis revealed no statistically significant differences between recalled lots (n = 8,686 tests) and nonrecalled lots (n = 8,699 tests) with respect to multiple parameters of assay performance, including frequency distribution of patient results (P = .575), prevalence of indeterminate results (P = .245), mean positive control signals (P = .26), and within-run calibrator precision (P = .68). The LCx-GC system's lack of an electronic data storage and retrieval capability prevented assessment of the impact of the quality control failure on the clinical performance of recalled lots, such as the one described herein, from being conducted in real time.American Journal of Clinical Pathology 07/2005; 123(6):809-16. · 2.88 Impact Factor
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ABSTRACT: Low-molecular-weight heparin (LMWH) has been a mainstay for the management of acute coronary syndromes (ACS) for almost a decade. However, several recent developments have seriously threatened the prominence of this drug class: (i) the adoption of an early invasive strategy, frequently leading to percutaneous coronary intervention (PCI) where the dosing and monitoring of LMWH is unfamiliar to most operators, (ii) the results of the SYNERGY trial, which not only failed to establish the superiority of enoxaparin over unfractionated heparin with respect to efficacy, but also demonstrated more bleeding with LMWH, and (iii) the results of the REPLACE-2 and ACUITY trials, which have demonstrated the advantages of an ACS and PCI treatment strategy based on direct thrombin inhibition with bivalirudin. To confront these challenges, cardiologists committed to the continued use of LMWH must develop safe and user-friendly approaches to transition patients from the noninvasive to invasive settings. This review summarizes an approach that takes advantage of the fact that LMWH can be readily monitored with the point-of-care activated clotting time (ACT) assay. This assay is inexpensive, available in virtually every catheterization laboratory, and familiar to most operators who monitor unfractionated heparin (UFH). A key concept that is presented is that the ACT is a more accurate measure of LMWH-induced anticoagulation than of UFH-induced anticoagulation. Our preliminary work suggests that during PCI operators should target an ACT of 175 seconds in the presence, and 200 seconds in the absence, of adjunctive glycoprotein IIb/IIIa inhibition. Sheath removal is recommended at an ACT < 160. These guidelines may facilitate continued use of LMWH, which has the potential to reduce cost (less expensive than bivalirudin), diminish the need for intravenous medication (can be administered subcutaneously in the noninvasive setting with minimal to no monitoring), and provide an ideal anticoagulant during PCI (easy to monitor with the ACT, at least partially reversible with protamine in the event of coronary perforation, effective antithrombin with no platelet activation, thereby potentially reducing the need for routine adjunctive IIb/IIIa inhibition).The Journal of invasive cardiology 12/2009; 21(12):653-64. · 1.57 Impact Factor