2012
DOI: 10.1097/poc.0b013e31825a9d3a
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Point-of-Care Hematology and Coagulation Testing in Primary, Rural Emergency, and Disaster Care Scenarios

Abstract: The purpose of this article is to review current principles and criteria for obtaining Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) waiver, identify existing point-of-care (POC) coagulation and hematology technologies, and analyze regulatory challenges regarding CLIA-waiver for those and future devices. CLIA ’88 documentation requires tests performed by laboratories with a Certificate of Waiver to be so simple that the likelihood of erroneous results by the user is negligible, or poses no unre… Show more

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Cited by 12 publications
(10 citation statements)
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“…There have been some studies describing benefits of POC INR in managing patients on warfarin in different settings. Several descriptive case studies have highlighted the benefit of POC INR testing by pharmacists for patients who live in rural or remote areas with limited access to hospitals and medical clinics [ 9 , 10 ]. A retrospective cohort study found improved INR control in patients at cardiology clinics who took part in a nurse-run, mobile POC anticoagulation therapy clinic [ 11 ].…”
Section: Discussionmentioning
confidence: 99%
“…There have been some studies describing benefits of POC INR in managing patients on warfarin in different settings. Several descriptive case studies have highlighted the benefit of POC INR testing by pharmacists for patients who live in rural or remote areas with limited access to hospitals and medical clinics [ 9 , 10 ]. A retrospective cohort study found improved INR control in patients at cardiology clinics who took part in a nurse-run, mobile POC anticoagulation therapy clinic [ 11 ].…”
Section: Discussionmentioning
confidence: 99%
“…Their application is increasing as they enable swift clinical decisions due to rapid therapeutic turnaround time. 1 In hemostasis field, a number of POCTs (activated clotting time, thromboelastography, platelet function, d -dimer, and so on) are available but measurement of international normalized ratio (INR) for monitoring warfarin therapy is the main test of this domain. 2 Despite the emergence of novel oral anticoagulants, warfarin is still the most commonly used oral anticoagulant worldwide.…”
Section: Introductionmentioning
confidence: 99%
“…In order to achieve timely results alongside ensuring patient convenience and satisfaction, robust technology could be considered after meticulous cost-benefit analysis. A study by Curtis et al [5] reported improved patient quality of care with the application of POCT. It enabled prompt clinical decisions supported by a quick therapeutic TAT.…”
Section: Discussionmentioning
confidence: 99%