Clin Chim Acta 2016;462:183–6. Audience: Clinical Laboratory Professionals. Provision of creatinine near/prior to such radiology studies allows for a rapid assessment of renal function without waiting for a CL assayed result.  Belsey R, Morrison J I, Whitlow K J, Baer D M, Nelson S, Hardwick D F. Managing bedside glucose testing in the hospital. Diagnosing heart failure with NT-proBNP point-of-care testing: lower costs and better outcomes. If you have been in contact with someone who has COVID-19, get tested and stay home and away from others for 14 days.  Lewandrowski E, Mac Millan D, Misiano D, Tochka L, Lewandrowski K. Process improvement for bedside capillary glucose testing in a large academic medical center: the impact of new technology on point-of-care testing. This type of testing is termed âpoint of careâ testing (POCT). It is not acceptable to scan a patient’s armband for personal use, run samples under a different mode on the analyzer or create identification numbers, and use the device for personal use. The Outstanding Contributions to Point of Care Testing Award recognizes an individual who has made an outstanding contribution in the field of critical and point of care testing. Positive POC results are reported as preliminary positive, and require parallel confirmatory testing at a licensed laboratory. Third generation glucose meters, currently in use, eliminate manual downloading, since the instruments are networked via an intranet to a data management computer. Some of our free educational and training resources include: Visit CDC’s Waived Tests page for more information and resources. The CAP Q-Probes study recommended that the data storage capabilities of blood glucose monitoring instruments be used, whenever practical, as a means of increasing compliance with “good” laboratory practices (12). Indeed, laboratories with more experience participating in PT have fewer failures (43), and laboratories that participate in multiple surveys, such as the CAP linearity (LN) survey, perform better on PT surveys (58). The laboratory or testing site must keep its certificate information current. Acad Emerg Med 2012;19:525–34. Success rates were higher for glucose EQA in the central laboratory compared to POCT. Scand J Clin Lab Invest 2019;79:298–304. Incorporation of rapid POCT BNP in early stroke management guidelines has been suggested to improve stroke risk stratification and accelerate the start of secondary preventive measures, further diagnostic examinations, and rehabilitation interventions; however, the demonstration of improved patient outcomes from this strategy has yet to be published. The Clinical Laboratory Improvement Amendments, CLIA, regulate all U.S. facilities that perform lab testing on human specimens.2 CLIA has identified tests that pharmacies can perform if they receive a CLIA waiver. POCT for cardiac markers has a definite place in management when a very short TAT is required such as in the Emergency Department.  International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Use Standard Precautions when handling specimens that will be tested for SARS-CoV-2. The specifics of these requirements will be dependent on the clinical use, such as screening, diagnosis or monitoring, of the POCT results, as well as to whether other systems are available for the performance of the analysis. Interfacing, connectivity, and data management are essential components of quality assurance for POCT. Manual results also pose a risk for transcription errors and duplicate charting. existing policies, procedures or guidelines which govern the use of point-of-care testing (POCT) and in particular, any mandatory requirements and quality management issues. The dispersion of POCT devices throughout the hospital and critical care environment creates unique challenges for data management. This reference was the most complete summary of POCT related evidence; however, it was not solely used without identification of additional references. Clinical utility studies require data on the influence of POCT on outcomes. POC preliminary positives must be reported to the local public health unit, and are actionable for initiating  Lehto L A, Bloigu A, Liikanen E, Ruokonen A. Interactive 2-step strategy for training nurses: a practical tool for achieving better-quality point-of-care glucose testing in hospital and primary health care unit. One caveat to this study is that before the educational intervention the meters used were different brands, different ages, and had no quality management. There are few studies on clinical utility, but more data exist on clinical validity and analytical performance. It will also determine the amount of material that can be ordered at one time and thus minimize the amount of testing required for acceptance of new lot/shipments. A value proposition may be another method to evaluate the benefits of POCT to all the stakeholders and services affected by the test (90). Clin Leadersh Manag Rev 2004;18:328–34. T Scott Isbell  Snaith B, Harris M A, Shinkins B, Messenger M, Lewington A, Jordaan M, et al. EQA is an important part of a quality improvement system and is used to monitor the participant performance and to assess the methods used (39). This resulted in performance that equaled the central laboratory at the 2-year mark; however, there was no statistical difference between the two since the program began. Am J Emerg Med 2018;36:916–21.  Pecoraro V, Banfi G, Germagnoli L, Trenti T. A systematic evaluation of immunoassay point-of-care testing to define impact on patients’ outcomes. In addition, strong interpersonal skills are required as POCCs serve as the primary interface between the central lab and the clinical testing personnel (i.e., operators). Guidance Documents are brought to you by the. It also automates billing. Fam Pract 2018;35:358–64. POCT devices should generate results that are comparable to those of the local laboratory (87). POCT in this process should theoretically improve radiology throughput; however, no studies were identified in the literature confirming faster throughput. Negative performance trends can provide documentation to discontinue POCT in clinical areas, while positive trends can demonstrate program improvement over time. Wayne, PA: Clinical and Laboratory Standards Institute; 2006. ED POCT troponin testing is included in the troponin discussion.  Bietenbeck A, Geilenkeuser W J, Klawonn F, Spannag l M, Nauck M, Petersmann A, et al.  Liu X, Dai Q, Jiang Y. Proficiency testing experience with College of American Pathologists’ programs at a university hospital in China from 2007 to 2011. The downloaded data permitted basic QC reports to be obtained, which enhanced oversight of the POCT program. Clin Biochem 2019;63:66–71. Does point-of-care testing impact length of stay in emergency departments (EDs)?  Kristensen G B, Nerhus K, Thue G, Sandberg S. Results and feasibility of an external quality assessment scheme for self-monitoring of blood glucose. Guidelines for Point of Care Testing The purpose of this document is to provide guidance to users of the technology and to describe the key quality requirements for the performance of Point of Care Testing (PoCT) to ensure the safety and quality of test results. Assistant Professor of Pathology, Microbiology, and Immunology In addition to archiving patient and quality control results, a variety of quality control reports are created. Does data management improve POCT outcomes? Evidence of better accuracy and quality of results was available after implementation of data management through collection of quantitative data for performance improvement. The specific indicators that a program chooses to monitor will depend on the institutional focus and may change over time as new goals and directions are developed for both POCT and the institution.
In the event of a specimen spill or splash. Arch Pathol Lab Med 2014;138:114–20. For POCT, there are generally insufficient staff to review the volume of data generated by POCT devices adequately and to ensure that thousands of patient results are correctly recorded in the patient’s medical record (33, 61). Note: Users may have trouble accessing the Cue™ link with Internet Explorer. The study also found that POCT devices used as stand-alone (stationary) analyzers are fairly promiscuous about data, accepting XXX instead of unique patient identifiers and ### or shared passwords in place of preregistered and trained users. Reporting Requirements for Point-of-Care Testing A CLIA-certified laboratory or testing site must report all COVID-19 diagnostic and screening test results to the individual who was tested or that individualâs healthcare provider. In its guideline of essential tools for implementation and management of a point-of-care testing program, the Clinical and Laboratory Standards Institute (CLSI) recommends multidisciplinary representation from performing sites to serve on the POCT committee (3). As manufacturers continue to introduce new POCT technologies, POCT is increasing in popularity, breadth of testing, and in the diversity of available clinical applications.  Stavelin A, Sandberg S. Harmonization activities of Noklus–a quality improvement organization for point-of-care laboratory examinations. Clin Lab Med 2009;29:433–48. Vanderbilt University School of Medicine This guideline is an update of the BSH 2008 Guideline for point of care testing: haematology (Briggs et al, 2008).Point of care testing (POCT) refers to any testing performed outside the hospital laboratory, near or at the site of the patient where the result influences patient management (ISO 15189:2012; ISO 22870:2016).  Halpern N A. Point of Care Testing . For testing that involves many devices and operators, is vendor assistance available for training at start-up? The laboratory cannot assure quality without knowledge of the occurrence of human or technological errors (74). This included comprehensive programs in education, training, quality assurance, and ongoing management support. Issues in the practical implementation of POCT: overcoming challenges. POCT data management systems further allow the generation of reports that can document quality measures for outpatient clinics, such as the percentage of patients in-range with PT/INR results for a coumadin clinic or the average hemoglobin A1c for diabetic patients in an endocrine practice. The guidance below addresses options for collection of â¦ BJGP Open 2018;2:bjgpopen18X101596. Successful PT results assume that patient test results will be successful, although the technique for analyzing PT is often different than collecting and analyzing a patient sample. This guideline provides recommendations to users and manufacturers of point-of-care coagulation testing devices for monitoring heparin and vitamin K antagonist therapy and for the evaluation of hemostasis, as well as to ensure reliable results comparable with those obtained by routine medical laboratory testing. Use of a comprehensive metabolic panel point-of-care test to reduce length of stay in the emergency department: a randomized controlled trial. HbA1c (92, 122–125): Multiple studies have confirmed that POCT HbA1c testing not only is a physician/patient satisfier (an immediate result to confirm/deny glycemic status with subsequent one-on-one discussion) but also showed improved HbA1c level and changes in treatment as needed, as well as improved costs by decreased testing, fewer clinic visits, and less hospital admissions. : a before and after study of 26 rural and remote EDs. So, indirectly, more experience with POCT and PT sample handling may enhance the performance of patient testing. Scand J Clin Lab Investig 1999;59:67–73. Improving the quality of point-of-care testing. These instrumented devices can capture a result at the time of testing and link that result to the device serial number, date, time, operator, and the quality control analyzed on that device. On average, 1%–2% of participants failed in the central lab, compared to 9%–10% for POCT EQA, and the central 95% of all glucose measurements in a central lab deviated less than 10% from the assigned target, whereas POCT central 95% of results exceeded 15% deviation from the target value (54). //
Saint Louis University School of Medicine What are the anticipated number of operators? Drug of abuse screening (92, 100): Only one study was clearly identified; it showed a decreased LOS in the ED with testing. Instrument-specific training by the manufacturer stresses quality control and quality assurance protocols and was the most effective predictor of acceptable PT performance for a benchtop chemistry analyzer, even more than professional background (55).  Nichols J, Poe S. Quality assurance, practical management, and outcomes of point-of-care testing: laboratory perspectives, Part I. Clin Lab Manag Rev 1999;13:341–50. While this guidance focuses on testing in nursing homes, several of the recommendations such as testing residents with signs or symptoms of COVID-19 and testing asymptomatic close contacts should also be applied to other long-term care facilities (e.g., assisted living facilities, intermediate care facilities for individuals with intellectual disabilities, institutions for mental disease, and psychiatric â¦ //
Practice Guidelines (LMPG) sponsored by the National Academy of Clinical Biochemistry (NACB). Manually, there was no way to verify documentation of all control testing, and patients were being treated on results from analyzers with documented control failures.