James H. Nichols

Development of a universal connectivity and data management system.

Point-of-care testing (POCT) is an increasingly popular method of delivering laboratory testing. Management of POCT is challenging given the variety of devices, locations, and staff that need to be coordinated to ensure quality results and meet regulatory guidelines. Electronic capture and transfer of data are preferred for managing POCT, but there is currently no standard method of connecting different devices. Johns Hopkins Medical Institutions (JHMI) developed a common data management system with interfaces to all of its POCT devices. All POCT data are collected in one database and analyzed in a similar fashion. Where data were once collected by carrying laptops to each nursing unit, the POCT devices can now connect directly to the database over the Internet. Algorithms have been created to automate the data analysis and review process. Over the several years that this software has been used, JHMI has experienced improved quality, accuracy, and management of its POCT program. The labor saved by increased automation of data review is refocused on enhancing the performance and scope of the program. Current connectivity and analysis algorithms have future application to remote consultation, management of home self-monitoring patients, and examination of real-time data.

Multiple site analytical evaluation of a portable blood gas/electrolyte analyzer for point of care testing.

Objective To evaluate the analytical performance of the SenDx 100 portable blood gas and electrolyte analyzer (SenDx Medical, Carlsbad, CA). Design Accuracy was evaluated by correlation of whole blood patient samples with the Nova Stat Profile 5 (Nova Biomedical, Waltham, MA) and the Ciba Corning 865 (Chiron Diagnostics, Medford, MA). Precision was evaluated using quality control materials (RNA Medical, Acton, MA). Setting Critical care laboratories and operating rooms in two institutions. Measurements and Main Results Precision studies performed at three different concentration levels for each analyte demonstrated intra-assay precision of ≤2.5% coefficient of variation and interassay precision of ≤4.0% coefficient of variation in all cases. Analysis of patient specimens in general showed good to excellent correlation to reference analyzers. Regression variables are tabulated. Conclusions The SenDx 100 portable blood gas and electrolyte analyzer is a simple and easy to use analyzer demonstrating acceptable performance compared with reference methods.

Design of an Integrated Clinical Data Warehouse

I t is our thesis that dramatic changes in the practice of laboratory medicine will emerge. Information from point-of-care devices and laboratories will be treated in a unified manner, and all devices will become components of integrated internet-connected virtual laboratories. Virtual laboratories will combine the immediacy offered by point-of-care devices with services offered by traditional laboratories such as quality assessment, quality control, data capture, and the dissemination of results to patients and clinicians. Development of software support for this new laboratory paradigm is a significant challenge. In order to tackle this challenge, we have developed and deployed a multi-tiered collection of database applications layered on top of both legacy and commodity database and computing platforms. In this paper, we provide a detailed description of our software architecture. Our software infrastructure supports integrated laboratory and point of care data. The infrastructure consists of a data warehouse, software to support POC device connectivity, and software to couple the data warehouse to LIS systems. Associated with the data warehouse are tools used to carry out POC device QC/QA, carry out panic value alerts. POC connectivity architecture is internet based and will soon include wireless links. A web portal is used to support data warehouse queries and to provide laboratory results and educational material to patients and physicians.

Investigation of Animal Bloods as Alternative Sources for Point-of-care Testing Validation and Proficiency Materials

Successful utilization of point-of-care testing (POCT) requires correlation between POCT and core laboratory values. Validation studies, including assessment of linearity and bias, precision, stability, and effectiveness as a blind check sample, establish this relationship. Traditionally, human blood has been used as the substrate for validation and proficiency materials. However, acquisition of human blood has become problematic because of increased costs of blood products and the need for institutional approval. In this study, the authors hypothesized that animal blood may provide a suitable alternative for POCT validation. They performed linearity studies on Accu-Chek Advantage glucose meters (Roche Diagnostics, Indianapolis, IN) and HemoCue B-Hemoglobin analyzers (HemoCue Inc., Lake Forest, CA) using bovine, horse, sheep, and swine blood. Using animal blood, the instruments demonstrated a linear response with close correlation to human blood. Precision calculations (human blood, n = 20; animal blood, n = 14) for HemoCue results yielded coefficients of variation between 0.5% and 2.6%. Glucose values (human blood, n = 17–20; animal blood, n = 15–20) had coefficients of variation between 2.5% and 3.9%. Using human and animal blood, blind check samples with concentrations of approximately 50 mg/dL and 175 mg/dL showed from −3.0 to 4.0 mg/dL bias for the low sample and −5.1 to 0.6% bias for the high sample between hospital unit and laboratory reference meters. Examination of hemolysis with repeated washes showed that bovine blood was the most stable of the animal blood, correlating with human blood values. Based on stability and handing characteristics, bovine blood seems to be ideally suited for POCT validation studies.