Portal de Periódicos da CAPES

Connectivity

2000; American Medical Association; Volume: 124; Issue: 8 Linguagem: Inglês

10.5858/2000-124-1108-c

1543-2165

Gerald J. Kost,

Quality and Safety in Healthcare

The use of point-of-care testing (testing at or near the site of patient care1,2) is expanding rapidly. Several new test clusters and patient-focused devices are on the horizon. The market growth rate is roughly 12% to 15% per annum, a rate several times larger than that of the central laboratory.3 Point-of-care testing has several advantages and disadvantages.2 Perhaps the worst disadvantage is the lack of "connectivity," that is, the lack of bidirectional communication between information systems and point-of-care devices. Portable, handheld, and even larger transportable whole-blood analyzers generally do not exchange adequate patient demographics, test results, and performance data with computerized systems, such as the laboratory information system, hospital information system, clinical data repository, critical care monitoring station, and clinical information system. Point-of-care data often are recorded manually or not at all, and only a small fraction of the data is captured electronically. In addition, most point-of-care technologies do not take advantage of existing network and wireless technologies. Full hybridization4,5 of diagnostic testing cannot be achieved without "information capture" from devices and enterprise-wide assimilation of point-of-care test results, including data from ex vivo and in vivo devices used in neonatology and critical care.6 Information capture will facilitate synthesis5 of knowledge and allow physicians to plan procedures and treatment more efficiently.On October 20, 1999, the Connectivity Industry Consortium (CIC) held its inaugural meeting in Redwood City, Calif. The point-of-care testing division of the American Association for Clinical Chemistry (Washington, DC), Agilent Technologies (formerly Hewlett-Packard Laboratories, Palo Alto, Calif), and Enterprise Analysis Corporation (Stamford, Conn) facilitated the start-up of the CIC. The goal of the CIC is to publish connectivity standards for point-of-care devices and to evaluate practical application of the standards at care provider sites. The CIC is a nonprofit corporation which receives voluntary financial support from several industry core members, as well as enthusiastic participation of both industry and care providers. The organizational structure of the CIC includes working committees and executive and administrative officers reporting to a board of directors. Connectivity Industry Consortium processes are open to public scrutiny, and progress is reported on the CIC Web site (http://www.poccic.org). Web-based access and commentary will improve quality, speed progress, and facilitate acceptance of the connectivity standards as they evolve, we hope, into professionally accepted practice guidelines.7 Since its inception, the CIC has been structuring working groups, conducting meetings, and crafting standards concepts. The standards process will address primarily the connectivity of devices used in critical care and hospital settings, but several meeting participants suggested a broader scope that would encompass all point-of-care devices and, eventually, wireless modalities of data transmission.Achieving complete connectivity and information capture is the millennium challenge for point-of-care testing! High-ranking priorities for the connectivity standards identified by CIC meeting participants (including the author) were: (1) flexible information model and optimized data content; (2) bidirectional interface and high speed (seconds); (3) generic device docks and ease of use; (4) forced downloading and device staging; (5) device vendor neutrality and commercial software interoperability; (6) compatibility with existing network infrastructures; (7) legally acceptable security and improved test integrity; (8) physician order entry and critical results notification; (9) efficient oversight of distributed testing sites; and (10) accurate fiscal accounting, reduced operating costs, and billing for tests. The topics addressed by the technical working groups included the device interface, the electronic data interface, the information model, security, and quality assurance/quality control and reporting. The members of CIC participate through working groups, care-provider review, or reports of progress on the Internet.Connectivity will enhance the accuracy of point-of-care testing. A recent study8 documenting the validity of the concept of therapeutic turnaround time (the time from test ordering to patient treatment1,2,4,5,9) showed that the statistical correlates of higher satisfaction observed for point-of-care testing (vs central laboratory testing) were timeliness, convenience, labor conservation and, importantly, improved patient care. Accuracy, per se, did not score as highly. However, to tolerate complacency for inaccurate point-of-care test results would undermine long-standing fundamental principles of medical practice and laboratory science.2 Information capture achieved by means of connectivity of point-of-care devices will help improve accuracy through timely tracking, comparison, and evaluation of quality monitors, such as quality control data, proficiency testing results, and external failure rates (eg, delays in therapeutic turnaround time that impede cardiopulmonary resuscitation). Knowledge of important interpretive elements, such as "delta" shifts, notable results, and patient trends, will become more accessible to the clinical team, thereby improving the continuity and value of diagnostic test results throughout the health system.A series of articles10–12 in the Archives demonstrates that handheld glucose meters each have a characteristic "signature" of strengths and weaknesses that are important in the care of critically ill patients. Another article13 (published elsewhere) addressed glucose measurement interference from drugs commonly used in critical care. Drug interference was minor with a benchtop whole-blood analyzer.14 We cannot ignore the fact that handheld glucose meters are common in critical care settings, such as the operating room, intensive care unit, and emergency department, albeit sometimes used as expedient devices in lieu of benchtop instruments because clinicians are forced to do more with less and to do it faster under the economic pressure of managed care. For critically ill patients, diagnostic-therapeutic processes evolve extremely rapidly.1,4,5,9 Connectivity and the resulting information capture will facilitate interdigitation of test results, pathophysiological events, and treatment changes, irrespective of the test method, measurement site, or patient location. Therefore, connectivity standards will lead to networking and systems integration, thereby enabling point-of-care testing to drive diagnostic-therapeutic processes more accurately and efficaciously.Connectivity also will improve accountability for point-of-care testing. Industry should be accountable for device limitations and for educating users about such shortcomings, while users should be accountable for knowledge of the status of the specimen and patient when interpreting results obtained with point-of-care devices. For example, avoiding the adverse effects of drugs and confounding variables on glucose meter results requires real-time knowledge of the patient's treatment regimen, PO2 value, pH, and hematocrit level.10–13 Alternately, concluding that there is hyperkalemia in vivo based on whole-blood analysis in vitro depends on ruling out hemolysis in the sample. These multidimensional tasks are best accomplished by accessing the patient's electronic file, correlating evidence, posting alerts on device screens during analyte measurement, and facilitating interpretation (perhaps with an expert system) at the point of care. Hence, connectivity, accuracy, and accountability occupy the same spatial/temporal domain and depend on both integration and temporal optimization.4,5,9 Optimal point-of-care systems must emphasize function and features, and must minimize time-consuming problems created by proprietary software, incompatible interfaces, overloaded modems, or even mismatched cables and connectors at the bedside.The triad of connectivity, accuracy, and accountability spans preanalytic through postanalytic phases of point-of-care testing and encompasses important technical objectives, such as system configuration (set device software parameters and measurement ranges via the network), valid use (allow or prohibit specified use in clinical sites and identify each patient), user authorization (download and upload acceptable access codes), operator quality (adopt uniform quality control/quality assurance processes, lock out noncompliant users, and flag criticals), method constraints (notify the operator about the patient's drug regimen, PO2 and hematocrit levels, and corresponding device limitations), and manual access (use touch-screen entry for results). From the clinical perspective, connectivity will facilitate performance improvement (broadcast quality control performance results and e-mail compliance rates15), resource utilization (recommend appropriate instrument platforms and track equipment and reagent costs by diagnosis-related groups), user competency (distribute training media and administer interactive examinations), site neutrality (establish uniform reference intervals), record keeping (transmit data, log events, store intelligently, and correlate diagnostic-therapeutic processes), trend mapping (monitor recent results and discourage repetitious testing), critical communications (post critical limits, alert critical test results, and send emergency messages), and outcomes optimization (merge test results with medical and economic outcomes management software9,16).In summary, connectivity standards constitute a milestone that will promote full clinical integration of point-of-care testing and timely exchange of vital information. Merging biochemical and physiological interpretations at the bedside will allow physicians to think prospectively rather than retrospectively and to synthesize accurate medical evidence as it unfolds, thereby optimizing knowledge.5 In some cases, such as cardiac injury marker testing by ambulance paramedics, prothrombin time monitoring by anticoagulated patients, and self-monitoring of blood glucose by diabetic children, connectivity of point-of-care test results to distant physicians has the potential to facilitate diagnosis, enhance therapy, and prevent errors.