Analysis of lawsuits related to diagnostic errors from point-of-care ultrasound in internal medicine, paediatrics, family medicine and critical care in the USA.

PURPOSE: The purpose of this study is to identify the extent of diagnostic error lawsuits related to point-of-care ultrasound (POCUS) in internal medicine, paediatrics, family medicine and critical care, of which little is known. METHODS: We conducted a retrospective review of the Westlaw legal database for indexed state and federal lawsuits involving the diagnostic use of POCUS in internal medicine, paediatrics, family medicine and critical care. Retrieved cases were reviewed independently by three physicians to identify cases relevant to our study objective. A lawyer secondarily reviewed any cases with discrepancies between the three reviewers. RESULTS: Our search criteria returned 131 total cases. Ultrasound was mentioned in relation to the lawsuit claim in 70 of the cases returned. In these cases, the majority were formal ultrasounds performed and reviewed by the radiology department, echocardiography studies performed by cardiologists or obstetrical ultrasounds. There were no cases of internal medicine, paediatrics, family medicine or critical care physicians being subjected to adverse legal action for their diagnostic use of POCUS. CONCLUSION: Our results suggest that concerns regarding the potential for lawsuits related to POCUS in the fields of internal medicine, paediatrics, family medicine and critical care are not substantiated by indexed state and federal filed lawsuits.

Assessing the Potential Deployment of Biosensors for Point-of-Care Diagnostics in Developing Countries: Technological, Economic and Regulatory Aspects.

Infectious diseases and antimicrobial resistance are major burdens in developing countries, where very specific conditions impede the deployment of established medical infrastructures. Since biosensing devices are nowadays very common in developed countries, particularly in the field of diagnostics, they are at a stage of maturity at which other potential outcomes can be explored, especially on their possibilities for multiplexing and automation to reduce the time-to-results. However, the translation is far from being trivial. In order to understand the factors and barriers that can facilitate or hinder the application of biosensors in resource-limited settings, we analyze the context from several angles. First, the technology of the devices themselves has to be rethought to take into account the specific needs and the available means of these countries. For this, we describe the partition of a biosensor into its functional shells, which define the information flow from the analyte to the end-user, and by following this partition we assess the strengths and weaknesses of biosensing devices in view of their specific technological development and challenging deployment in low-resource environments. Then, we discuss the problem of cost reduction by pointing out transversal factors, such as throughput and cost of mistreatment, that need to be re-considered when analyzing the cost-effectiveness of biosensing devices. Beyond the technical landscape, the compliance with regulations is also a major aspect that is described with its link to the validation of the devices and to the acceptance from the local medical personnel. Finally, to learn from a successful case, we analyze a breakthrough inexpensive biosensor that is showing high potential with respect to many of the described aspects. We conclude by mentioning both some transversal benefits of deploying biosensors in developing countries, and the key factors that can drive such applications.

Economic impact of rapid diagnostic methods in Clinical Microbiology: Price of the test or overall clinical impact. / Impacto económico de los métodos de diagnóstico rápido en Microbiología Clínica: precio de la prueba o impacto clínico global.

The need to reduce the time it takes to establish a microbiological diagnosis and the emergence of new molecular microbiology and proteomic technologies has fuelled the development of rapid and point-of-care techniques, as well as the so-called point-of-care laboratories. These laboratories are responsible for conducting both techniques partially to response to the outsourcing of the conventional hospital laboratories. Their introduction has not always been accompanied with economic studies that address their cost-effectiveness, cost-benefit and cost-utility, but rather tend to be limited to the unit price of the test. The latter, influenced by the purchase procedure, does not usually have a regulated reference value in the same way that medicines do. The cost-effectiveness studies that have recently been conducted on mass spectrometry in the diagnosis of bacteraemia and the use of antimicrobials have had the greatest clinical impact and may act as a model for future economic studies on rapid and point-of-care tests.

An overview of forensic drug testing methods and their suitability for harm reduction point-of-care services.

Given the current opioid crisis around the world, harm reduction agencies are seeking to help people who use drugs to do so more safely. Many harm reduction agencies are exploring techniques to test illicit drugs to identify and, where possible, quantify their constituents allowing their users to make informed decisions. While these technologies have been used for years in Europe (Nightlife Empowerment & Well-being Implementation Project, Drug Checking Service: Good Practice Standards; Trans European Drugs Information (TEDI) Workgroup, Factsheet on Drug Checking in Europe, 2011; European Monitoring Centre for Drugs and Drug Addiction, An Inventory of On-site Pill-Testing Interventions in the EU: Fact Files, 2001), they are only now starting to be utilized in this context in North America. The goal of this paper is to describe the most common methods for testing illicit substances and then, based on this broad, encompassing review, recommend the most appropriate methods for testing at point of care.Based on our review, the best methods for point-of-care drug testing are handheld infrared spectroscopy, Raman spectroscopy, and ion mobility spectrometry; mass spectrometry is the current gold standard in forensic drug analysis. It would be prudent for agencies or clinics that can obtain the funding to contact the companies who produce these devices to discuss possible usage in a harm reduction setting. Lower tech options, such as spot/color tests and immunoassays, are limited in their use but affordable and easy to use.

Bedside Glucose Monitoring-Is it Safe? A New, Regulatory-Compliant Risk Assessment Evaluation Protocol in Critically Ill Patient Care Settings.

OBJECTIVES: New data have emerged from ambulatory and acute care settings about adverse patient events, including death, attributable to erroneous blood glucose meter measurements and leading to questions over their use in critically ill patients. The U.S. Food and Drug Administration published new, more stringent guidelines for glucose meter manufacturers to evaluate the performance of blood glucose meters in critically ill patient settings. The primary objective of this international, multicenter, multidisciplinary clinical study was to develop and apply a rigorous clinical accuracy assessment algorithm, using four distinct statistical tools, to evaluate the clinical accuracy of a blood glucose monitoring system in critically ill patients. DESIGN: Observational study. SETTING: Five international medical and surgical ICUs. PATIENTS: All patients admitted to critical care settings in the centers. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Glucose measurements were performed on 1,698 critically ill patients with 257 different clinical conditions and complex treatment regimens. The clinical accuracy assessment algorithm comprised four statistical tools to assess the performance of the study blood glucose monitoring system compared with laboratory reference methods traceable to a definitive standard. Based on POCT12-A3, the Clinical Laboratory Standards Institute standard for hospitals about hospital glucose meter procedures and performance, and Parkes error grid clinical accuracy performance criteria, no clinically significant differences were observed due to patient condition or therapy, with 96.1% and 99.3% glucose results meeting the respective criteria. Stratified sensitivity and specificity analysis (10 mg/dL glucose intervals, 50-150 mg/dL) demonstrated high sensitivity (mean = 95.2%, SD = ± 0.02) and specificity (mean = 95. 8%, SD = ± 0.03). Monte Carlo simulation modeling of the study blood glucose monitoring system showed low probability of category 2 and category 3 insulin dosing error, category 2 = 2.3% (41/1,815) and category 3 = 1.8% (32/1,815), respectively. Patient trend analysis demonstrated 99.1% (223/225) concordance in characterizing hypoglycemic patients. CONCLUSIONS: The multicomponent, clinical accuracy assessment algorithm demonstrated that the blood glucose monitoring system was acceptable for use in critically ill patient settings when compared to the central laboratory reference method. This clinical accuracy assessment algorithm is an effective tool for comprehensively assessing the validity of whole blood glucose measurement in critically ill patient care settings.

The Role of Pharmacists and Pharmacy Education in Point-of-Care Testing.

Point-of-care testing (POCT) is defined as laboratory testing conducted close to the site of patient care. Although performed originally primarily by clinical staff for acute conditions, recent advances in technology have made such testing possible for disease screening and prevention across a wide range of conditions in virtually any setting, and often by individuals with little or no training. With the ongoing evolution in POCT, numerous concerns have arisen about the quality and accuracy of the tests, comparability between multiple tests for the same endpoint, interpretation of test results, and whether and how results should be used for therapeutic decisions and included in a patient's medical record. The pharmacist is well-positioned to manage and interpret POCT performed outside of the usual clinical settings. However, educational and regulatory changes are needed to enable pharmacists to take on this emerging activity effectively.

Analysis of lawsuits related to point-of-care ultrasonography in neonatology and pediatric subspecialties.

OBJECTIVE: Point-of-care ultrasonography (POCUS) is becoming increasingly available for neonatologists and pediatric subspecialists (PSS); however, concerns over potential litigation from possible missed diagnoses or incorrect management have been documented. This study aims to define the extent and quality of lawsuits filed against neonatologists and PSS related to POCUS. STUDY DESIGN: We conducted a retrospective study of all United States reported state and federal cases in the Westlaw database from January 1990 through October 2015. Cases were reviewed and included if either a neonatologist or PSS were accused of misconduct or the interpretation or failure to perform an ultrasound/echocardiogram was discussed. Descriptive statistics were used to evaluate the data. RESULTS: Our search criteria returned 468 results; 2 cases were determined to be relevant to the study objective. The two cases alleged a failure to perform a diagnostic test and implicated POCUS as an option. There were no cases of neonatologists and PSS being sued for POCUS performance or interpretation. CONCLUSION: This study of a major legal database suggests that POCUS use and interpretation is not a significant cause of lawsuits against neonatologists and PSS.

A review of lawsuits related to point-of-care emergency ultrasound applications.

INTRODUCTION: New medical technology brings the potential of lawsuits related to the usage of that new technology. In recent years the use of point-of-care (POC) ultrasound has increased rapidly in the emergency department (ED). POC ultrasound creates potential legal risk to an emergency physician (EP) either using or not using this tool. The aim of this study was to quantify and characterize reported decisions in lawsuits related to EPs performing POC ultrasound. METHODS: We conducted a retrospective review of all United States reported state and federal cases in the Westlaw database. We assessed the full text of reported cases between January 2008 and December 2012. EPs with emergency ultrasound fellowship training reviewed the full text of each case. Cases were included if an EP was named, the patient encounter was in the emergency department, the interpretation or failure to perform an ultrasound was a central issue and the application was within the American College of Emergency Physician (ACEP) ultrasound core applications. In order to assess deferred risk, cases that involved ultrasound examinations that could have been performed by an EP but were deferred to radiology were included. RESULTS: We identified five cases. All reported decisions alleged a failure to perform an ultrasound study or a failure to perform it in a timely manner. All studies were within the scope of emergency medicine and were ACEP emergency ultrasound core applications. A majority of cases (n=4) resulted in a patient death. There were no reported cases of failure to interpret or misdiagnoses. CONCLUSION: In a five-year period from January 2008 through December 2012, five malpractice cases involving EPs and ultrasound examinations that are ACEP core emergency ultrasound applications were documented in the Westlaw database. All cases were related to failure to perform an ultrasound study or failure to perform a study in a timely manner and none involved failure to interpret or misdiagnosis when using of POC ultrasound.

[Near-patient testing devices to monitor vitamin K antagonists]. / Mesure délocalisée de l'INR pour la surveillance des traitements par antivitamine K.

Monitoring of the anticoagulant effect with the International normalized ratio (INR) is essential for patients receiving vitamin K antagonists (VKAs). The majority of point of care (POC) devices for INR monitoring has shown a good precision and accuracy with results similar to those obtained in a laboratory. In many countries, INR POC devices are widely used at home by the patients for self-testing. Their use in the hospital by the clinical staff (doctor or nurses) for bedside measurement is also growing. The INR POC testing is performed using fully automated devices. Capillary blood samples are easy to obtain. In the emergency room, POC INR devices are commonly used. This improves the quality of care for patient with suspicion of VKAs overdosage. INR measurement using bedside monitors is also of great interest in care units for specific populations of patients like paediatrics or geriatrics. Moreover, bedside INR monitoring may be useful in anticoagulant clinics or when the care unit is far from a laboratory. Although the bedside INR monitors are easy to use, their implementation requires adequate training and intermittent re-evaluation of any person performing the tests to ensure reliability of results. Such equipment must comply with EN ISO 22870 standard for POC testing accreditation, under the supervision of a biologist. In order to achieve these targets, connect the instrument to the laboratory's data management system is essential.

Point-of-care test (POCT) INR: hope or illusion?

In the last decade, point-of-care tests were developed to provide rapid generation of test results. These tests have increasingly broad applications. In the area of hemostasis, the international normalized ratio, INR point-of-care test (POCT INR), is the main test of this new proposal. This test has great potential benefit in situations where the quick INR results influences clinical decision making, as in acute ischemic stroke, before surgical procedures and during cardiac surgery. The INR POCT has the potential to be used for self-monitoring of oral anticoagulation in patients under anticoagulant therapy. However, the precision and accuracy of INR POCT still need to be enhanced to increase effectiveness and efficiency of the test. Additionally, the RDC / ANVISA Number 302 makes clear that the POCT testing must be supervised by the technical manager of the Clinical Laboratory in the pre-analytical, analytical and post-analytical. In practice, the Clinical Laboratory does not participate in the implementation of POCT testing or release of the results. Clinicians have high expectation with the incorporation of INR POCT in clinical practice, despite the limitations of this method. These professionals are willing to train the patient to perform the test, but are not legally responsible for the quality of it and are not prepared for the maintenance of equipment. The definition of who is in charge for the test must be one to ensure the quality control.

A framework for key considerations regarding point-of-care screening of newborns.

Newborn screening is performed under public health authority, with analysis carried out primarily by public health laboratories or other centralized laboratories. Increasingly, opportunities to improve infant health will arise from including screening tests that are completed at the birth centers instead of in centralized laboratories, constituting a significant shift for newborn screening. This report summarizes a framework developed by the US Secretary of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children based on a series of meetings held during 2011 and 2012. These meetings were for the purpose of evaluating whether conditions identifiable through point-of-care screening should be added to the recommended universal screening panel, and to identify key considerations for birth hospitals, public health agencies, and clinicians when point-of-care newborn screening is implemented.

RNI Point-of-care test (POCT): esperança ou ilusão? / Point-of-care test (POCT) INR: hope or illusion?

Na última década, foram desenvolvidos os testes point-of-care visando à geração rápida de resultados de exames. Na área da hemostasia, a razão normatizada internacional, o RNI point-of-care test (RNI-POCT), constitui o principal exame dessa nova proposta. Esse teste tem grande potencial de benefício em situações em que o resultado rápido da RNI influencia a tomada de decisão clínica, como no acidente vascular cerebral isquêmico agudo, antes de procedimentos cirúrgicos e durante cirurgias cardíacas, além de permitir que o próprio paciente faça a monitoração da anticoagulação oral. Entretanto, a precisão e a acurácia da RNI-POCT ainda precisam ser aprimoradas para aumentar a eficácia e a eficiência do teste. A RDC/ANVISA Nº 302 deixa claro que os testes POCT devem ser supervisionados pelo responsável técnico do Laboratório Clínico nas fases pré-analítica, analítica e pós-analítica. Na prática, o laboratório não participa da execução desses testes e liberação dos resultados, não sendo, portanto, o mais indicado para garantir a qualidade dos mesmos. Os clínicos, especialmente aqueles envolvidos com a anticoagulação oral de pacientes, têm grande expectativa na incorporação da RNI-POCT na prática diária, apesar das limitações desse método. Esses profissionais mostram-se dispostos a treinar o paciente para realizar o teste, mas legalmente não são os responsáveis pela qualidade do mesmo e não estão preparados para a manutenção dos equipamentos. A definição do responsável pelo RNI-POCT precisa ser reavaliada pelos órgãos competentes, de forma a garantir que seja cumprida, e constitui etapa essencial para assegurar a qualidade do teste e, consequentemente, sua maior utilização.

In the last decade, point-of-care tests were developed to provide rapid generation of test results. These tests have increasingly broad applications. In the area of hemostasis, the international normalized ratio, INR point-of-care test (POCT INR), is the main test of this new proposal. This test has great potential benefit in situations where the quick INR results influences clinical decision making, as in acute ischemic stroke, before surgical procedures and during cardiac surgery. The INR POCT has the potential to be used for self-monitoring of oral anticoagulation in patients under anticoagulant therapy. However, the precision and accuracy of INR POCT still need to be enhanced to increase effectiveness and efficiency of the test. Additionally, the RDC / ANVISA Number 302 makes clear that the POCT testing must be supervised by the technical manager of the Clinical Laboratory in the pre-analytical, analytical and post-analytical. In practice, the Clinical Laboratory does not participate in the implementation of POCT testing or release of the results. Clinicians have high expectation with the incorporation of INR POCT in clinical practice, despite the limitations of this method. These professionals are willing to train the patient to perform the test, but are not legally responsible for the quality of it and are not prepared for the maintenance of equipment. The definition of who is in charge for the test must be one to ensure the quality control.

Analysis of lawsuits filed against emergency physicians for point-of-care emergency ultrasound examination performance and interpretation over a 20-year period.

OBJECTIVE: The study aims to define extent of lawsuits filed against emergency physicians (EPs) over point-of-care emergency ultrasound (US) during the last 20 years. METHODS: We performed a nationwide search of the WESTLAW legal database for filed lawsuits involving EPs and US. WESTLAW covers all state and federal lawsuits dating back to 1939. Using an electronic search feature, all states were searched using emergency and US as key words. The database automatically accounts for different variants on US such as sonography. An attorney who is also boarded in and practices emergency medicine, as well as an emergency US expert, reviewed returned cases. Descriptive statistics were used to evaluate the data. RESULTS: Using the search criteria and excluding obvious radiology suits, 659 cases were returned and reviewed. There were no cases of EPs being sued for performance or interpretation of point-of-care US. There was one case alleging EP failure to perform point-of-care US and diagnose an ectopic before it ruptured. This case was won by the defense. There were no cases against EPs for common causes of radiology and obstetric litigation including sexual assault during endovaginal US. Cases of missed testicular torsion on US were frequent in the emergency setting but none linked EP US. CONCLUSIONS: Only one case filed against EPs over the last 2 decades was identified, it was over failure to perform US. Most frequent litigations against radiologists and obstetricians are unlikely to be duplicated in the emergency department, and future litigations may also come from EP failure to perform point-of-care US.

Small miracles: point-of-care testing.

Point-of-care testing (POCT), also called "near patient," "bedside," or "extra-laboratory testing," means any laboratory test performed in patient-care areas or patients' homes, usually by clinical staff who are not trained in clinical laboratory sciences, or by patients themselves. POCT devices may be as different as a hand-held, single-use device or a bench-top analyzer. The growth of POCT has had considerable impact on health care, but cannot replace clinical judgment. The Food and Drug Administration reviews and approves most POCT devices, and the Centers for Medicare & Medicaid Services makes coverage determinations on their usage. POCT is best used when a clinician is prepared to act on test results immediately.

Regulatory compliance for point-of-care testing: 2009 United States perspective.

All clinical laboratory testing in the United States is regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88 or CLIA) and overseen by the Centers for Medicare and Medicaid Services. CLIA profoundly changed the prevailing United States regulatory philosophy by imposing uniform requirements for all clinical laboratory testing regardless of where tests are performed. In the hospital, regulatory compliance is usually ensured by regular inspections of the laboratory by either the Joint Commission or by the College of American Pathologists. These organizations may include requirements beyond the minimum standard mandated by CLIA. This article reviews the status of regulatory compliance of point-of-care testing from a perspective of the current regulations in effect in the United States in 2009.