Recommendations for proficiency testing criteria for hemoglobin A1c based on the Shanghai Center for Clinical Laboratory’s study

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Yi Ju ◽  
Zhimin Tim Cao ◽  
Qing Li ◽  
Liping Tang ◽  
Yuanzhu Ou ◽  
...  
Keyword(s):  
Proficiency Testing ◽  
Clinical Utility ◽  
Hemoglobin A1c ◽  
Clinical Laboratory ◽  
Scientific Evidence ◽  
Target Values ◽  
The Us ◽  
The Usa ◽  
Glycated Hemoglobin A ◽  
Blood Specimens

Abstract Objectives The US Centers for Medicare & Medicaid Services proposed in 2019 that glycated hemoglobin A1c (HbA1c) be a CLIA′88 regulated analyte. People who commented expressed concerns that the proposed acceptance limit (AL, HbA1c in NGSP unit) ±10% for proficiency testing (PT) would be unable to maintain already improved analytical performance and guarantee the clinical utility of HbA1c testing. Assessing impact of various ALs on PT performance is needed to provide scientific evidence for adopting an appropriate AL. Methods Ten patient EDTA-whole blood specimens were distributed to 318 and 336 laboratories in the 2018 and 2019 PT events organized by Shanghai Center for Clinical Laboratory (SCCL). HbA1c concentrations were measured by participants using various methodologies commonly used in the USA and China. Targets were determined using secondary reference measurement procedures (SRM) at SCCL. “Failed Results” were those outside the SRM-defined target ± AL (5% through 10%). Laboratories with Failed Results ≥2 out of five samples per PT event obtained Event Unsatisfactory Status. Results HbA1c target values ranged 33.3 mmol/mol (5.2 NGSP%) −102.2 mmol/mol (11.5 NGSP%) for 2018 event, and 33.3 mmol/mol (5.2 NGSP%) −84.7 mmol/mol (9.9 NGSP%) for 2019 event. Overall Laboratory Event Unsatisfactory Rates were 11.3–12.2%, 4.8–5.3%, 0.9–3.1%, 0.6–2.2%, 0.6–1.4% and 0.6–1.4%, at AL of ±5, ±6, ±7, ±8, ±9 and ±10%, respectively. Conclusions The AL (in NGSP unit) of ±6% or ±7% for PT evaluation of HbA1c results would be appropriate, with satisfactory event scores for about 95% of participant laboratories in a PT event.

FDA’s reduced exposure marketing order for IQOS: why it is not a reliable global model

2021 ◽  
pp. tobaccocontrol-2020-056316
Author(s):  
Lauren Kass Lempert ◽  
Stella Bialous ◽  
Stanton Glantz
Keyword(s):  
Public Relations ◽  
Tobacco Control ◽  
Scientific Evidence ◽  
Tobacco Product ◽  
Tobacco Products ◽  
Sales And Marketing ◽  
Philip Morris ◽  
The Us ◽  
The Usa ◽  
The Difference

The US Food and Drug Administration (FDA) issued orders in July 2020 authorising Philip Morris Products S.A. to market its heated tobacco product (HTP) IQOS inside the USA with claims that it reduces exposure to some dangerous substances. FDA’s ‘reduced-exposure’ orders explicitly prohibit the marketing of IQOS with claims that IQOS will reduce harm or the risk of tobacco-related diseases. Under US law, FDA’s IQOS orders are problematic because FDA disregarded valid scientific evidence that IQOS increases exposure to other dangerous toxins and that Philip Morris Products S.A. failed to demonstrate that consumers understand the difference between reduced-exposure and reduced-harm claims. Unfortunately, both ‘reduced-exposure’ and ‘reduced-harm’ are classified as ‘modified risk tobacco products’ under US law. Exploiting this confusion, Philip Morris International used the FDA decision as the basis for marketing and public relations campaigns outside the USA to press governments to reverse policies that ban or regulate the sales and marketing of HTPs, including IQOS. Parties to the WHO Framework Convention on Tobacco Control should reject tobacco companies’ unsubstantiated explicit or implied claims of reduced harm associated with HTPs and resist Philip Morris International’s and other companies’ calls to relax HTP regulations based on the FDA’s actions. Instead, parties should adopt policies aligned with the Framework Convention on Tobacco Control when dealing with HTPs and other novel tobacco products.

scholarly journals Accuracy-Based Vitamin D Survey: Six Years of Quality Improvement Guided by Proficiency Testing

2019 ◽  
Vol 143 (12) ◽  
pp. 1531-1538 ◽  
Author(s):  
Patrick Erdman ◽  
Darryl E. Palmer-Toy ◽  
Gary Horowitz ◽  
Andrew Hoofnagle
Keyword(s):  
Vitamin D ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
Matrix Effects ◽  
Pearson Correlation ◽  
Correlation Coefficients ◽  
Reference Method ◽  
Serum Samples ◽  
Testing Program ◽  
Target Values

Context.— The goal of the College of American Pathologists Accuracy-Based Proficiency Testing Program is to promote the quality, standardization, and harmonization of clinical laboratory results through proficiency testing specimens that are free from matrix effects, have target values that are traceable to reference methods, and that probe the limitations of current methods. Objective.— To summarize the first 6 years of the Accuracy-Based Vitamin D Survey and highlight key insights from the data generated as it relates to assay performance. Design.— Accuracy-based challenges were created by using pooled human serum samples. Certain samples were derived from participants in an institutional review board–approved protocol in which vitamin D–deficient participants were treated with ergocalciferol (vitamin D2). Reference targets for the survey were set by the Centers for Disease Control and Prevention using isotope-dilution liquid chromatography–tandem mass spectrometry. Each method was compared with the reference method procedure over the course of the program (n = 43 proficiency testing samples). Results.— Linear regression versus the reference method procedure revealed proportional biases across the methods, ranging from 0.0% to 16.7%. Pearson correlation coefficients (r2) ranged from 0.902 to 0.996. Results were influenced by the concentration of 25-hydroxyvitamin D2 as well as the C-3 epimer of 25-hydroxyvitamin D3. During the 6 years, 2 manufacturers altered their assays to match the reference method procedure more closely. Conclusions.— There is considerable bias, both proportional bias and sample-specific matrix effects, affecting many assays. This ongoing accuracy-based proficiency testing program for vitamin D will provide the data needed for laboratories and manufacturers to improve their assays and thereby patient care.

Laboratory Sanctions for Proficiency Testing Sample Referral and Result Communication: A Review of Actions From 1993–2006

2009 ◽  
Vol 133 (6) ◽  
pp. 979-982
Author(s):  
Anthony A. Killeen
Keyword(s):  
Proficiency Testing ◽  
Human Services ◽  
Clinical Laboratory ◽  
Testing Sample ◽  
Health And Human Services ◽  
Department Of Health ◽  
Clinical Laboratories ◽  
The Us ◽  
Key Terms ◽  
Clinical Laboratory Improvement Amendments

Abstract Context.—The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for proficiency testing (PT) include prohibitions against intentional PT sample referral or result communication, and specify sanctions against laboratories that violate these regulations. There has been little published analysis of sanctions against clinical laboratories because of PT violations. Objective.—To examine the application of principal sanctions as reported by the Centers for Medicare and Medicaid Services annually in the Laboratory Registry and to examine relevant aspects of judicial hearings and appeals in these cases. Design.—The Laboratory Registry was examined for all available years (1993–2006) to determine the incidence of application of principal sanctions for PT violations. In addition, the decisions from the US Department of Health and Human Services hearings and appeals were reviewed to better understand the judicial disposition of these cases. Results.—During the 14-year period examined, 78 laboratories received a principal sanction for a PT violation involving sample referral or result communication. During the same period, the number of laboratories in nonexempt states that would be expected to have participated in PT averaged 45 983. The interpretive meaning of the key terms intentional and referral, and the implications for sanctioned laboratories and their owners and operators are discussed. Conclusions.—Applications of a principal sanction for a PT violation were rare during the period of this study. However, the consequences of the imposition of such a sanction are severe. Suggestions are offered on policies and practices to minimize the risk of a PT sample referral or result communication.

Measurement Invariance of a Universal Behavioral Screener Across Samples From the USA and Germany

2018 ◽  
Vol 34 (2) ◽  
pp. 87-100 ◽  
Author(s):  
Gino Casale ◽  
Robert J. Volpe ◽  
Brian Daniels ◽  
Thomas Hennemann ◽  
Amy M. Briesch ◽  
...  
Keyword(s):  
Measurement Invariance ◽  
Student Behavior ◽  
Cross Cultural ◽  
Cross Cultural Comparison ◽  
School Based ◽  
Cultural Research ◽  
Universal Screener ◽  
Confirmatory Factor ◽  
The Us ◽  
The Usa

Abstract. The current study examines the item and scalar equivalence of an abbreviated school-based universal screener that was cross-culturally translated and adapted from English into German. The instrument was designed to assess student behavior problems that impact classroom learning. Participants were 1,346 K-6 grade students from the US (n = 390, Mage = 9.23, 38.5% female) and Germany (n = 956, Mage = 8.04, 40.1% female). Measurement invariance was tested by multigroup confirmatory factor analysis (CFA) across students from the US and Germany. Results support full scalar invariance between students from the US and Germany (df = 266, χ2 = 790.141, Δχ2 = 6.9, p < .001, CFI = 0.976, ΔCFI = 0.000, RMSEA = 0.052, ΔRMSEA = −0.003) indicating that the factor structure, the factor loadings, and the item thresholds are comparable across samples. This finding implies that a full cross-cultural comparison including latent factor means and structural coefficients between the US and the German version of the abbreviated screener is possible. Therefore, the tool can be used in German schools as well as for cross-cultural research purposes between the US and Germany.

Sanctions of the USA and the Policy of Bank of Russia:double Blow to the National Economy

2014 ◽  
pp. 13-29 ◽  
Author(s):  
S. Glazyev
Keyword(s):  
National Security ◽  
Economic Sanctions ◽  
Capital Flight ◽  
Practical Advice ◽  
The Us ◽  
Monetary Authorities ◽  
The Usa ◽  
Simultaneous Adoption ◽  
The Eu

This article examines fundamental questions of monetary policy in the context of challenges to the national security of Russia in connection with the imposition of economic sanctions by the US and the EU. It is proved that the policy of the Russian monetary authorities, particularly the Central Bank, artificially limiting the money supply in the domestic market and pandering to the export of capital, compounds the effects of economic sanctions and plunges the economy into depression. The article presents practical advice on the transition from external to domestic sources of long-term credit with the simultaneous adoption of measures to prevent capital flight.

Possibility of Using in Russia the Experience of LED Lighting Application at the USA Airfields

2019 ◽  
pp. 71-77
Author(s):  
Vladimir V. Vorozhikhin ◽  
Eugenia L. Moreva ◽  
Vladimir G. Starovoytov ◽  
Igor G. Tyutyunnik
Keyword(s):  
Air Transportation ◽  
Improve Quality ◽  
Led Lighting ◽  
The Us ◽  
The Usa ◽  
Quality And Reliability ◽  
Lighting Application

The purpose of this paper is an investigation of LEDs illumination experience at US-based aerodromes with an assessment of its feasibility and its necessity in Russia. The following methods were used: the analysis of aerodrome lighting requirements; the review and the analysis of development features in aerodrome LEDs illumination; the experience analysis of LEDs illumination of US-based aerodromes; the deductive analysis and the assessment synthesis of feasibility and necessity of US experience in LEDs illumination at Russian-based aerodromes. The following results were achieved: – The analysis of issues and opportunities was conducted for development of LEDs illumination at US-based aerodromes and of American experts’ recommendations for its use; – The cases were taken for use and assessment of development in LEDs illumination at US-based aerodromes; – The review and the analysis were conducted in relation to a developing market of LEDs illumination at Russian-based aerodromes. The main conclusion is that the US experience will improve quality and reliability of service provided in air transportation, comfort, and safety of Russian flights, as well as competitiveness of Russian- based airports and airlines (indirectly).

Feasibility and Clinical Implications of Remotely Guided Ultrasound Examinations

2020 ◽  
Vol 91 (7) ◽  
pp. 592-596
Author(s):  
Quinn Dufurrena ◽  
Kazi Imran Ullah ◽  
Erin Taub ◽  
Connor Leszczuk ◽  
Sahar Ahmad
Keyword(s):  
Clinical Utility ◽  
Regional Wall Motion ◽  
Subjective Assessment ◽  
Clinical Implications ◽  
Pilot Studies ◽  
Objective Quality ◽  
The Us ◽  
Regional Wall Motion Abnormalities ◽  
Wall Motion Abnormalities

BACKGROUND: Remotely guided ultrasound (US) examinations carried out by nonmedical personnel (novices) have been shown to produce clinically useful examinations, at least in small pilot studies. Comparison of the quality of such exams to those carried out by trained medical professionals is lacking in the literature. This study compared the objective quality and clinical utility of cardiac and pulmonary US examinations carried out by novices and trained physicians.METHODS: Cardiac and pulmonary US examinations were carried out by novices under remote guidance by an US expert and independently by US trained physicians. Exams were blindly evaluated by US experts for both a task-based objective score as well as a subjective assessment of clinical utility.RESULTS: Participating in the study were 16 novices and 9 physicians. Novices took longer to complete the US exams (median 641.5 s vs. 256 s). For the objective component, novices scored higher in exams evaluating for pneumothorax (100% vs. 87.5%). For the subjective component, novices more often obtained clinically useful exams in the assessment of cardiac regional wall motion abnormalities (56.3% vs. 11.1%). No other comparisons yielded statistically significant differences between the two groups. Both groups had generally higher scores for pulmonary examinations compared to cardiac. There was variability in the quality of exams carried out by novices depending on their expert guide.CONCLUSION: Remotely guided novices are able to carry out cardiac and pulmonary US examinations with similar, if not better, technical proficiency and clinical utility as US trained physicians, though they take longer to do so.Dufurrena Q, Ullah KI, Taub E, Leszczuk C, Ahmad S. Feasibility and clinical implications of remotely guided ultrasound examinations. Aerosp Med Hum Perform. 2020; 91(7):592–596.

Interaction of Ukrainian Diaspora and the USA Government Regarding Celebration of Ukrainian Independence Day on January 22

2018 ◽  
Vol 1 (47) ◽  
pp. 136-145
Author(s):  
Halyna Shchyhelska
Keyword(s):  
United States ◽  
House Of Representatives ◽  
The United States ◽  
100Th Anniversary ◽  
Totalitarian Regime ◽  
The Public ◽  
Us Congress ◽  
The Us ◽  
Public Consciousness ◽  
The Usa

2018 marks the 100th anniversary of the proclamation of Ukrainian independence. OnJanuary 22, 1918, the Ukrainian People’s Republic proclaimed its independence by adopting the IV Universal of the Ukrainian Central Rada, although this significant event was «wiped out» from the public consciousness on the territory of Ukraine during the years of the Soviet totalitarian regime. At the same time, January 22 was a crucial event for the Ukrainian diaspora in the USA. This article examines how American Ukrainians interacted with the USA Government institutions regarding the celebration and recognition of the Ukrainian Independence day on January 22. The attention is focused on the activities of ethnic Ukrainians in the United States, directed at the organization of the special celebration of the Ukrainian Independence anniversaries in the US Congress and cities. Drawing from the diaspora press and Congressional Records, this article argues that many members of Congress participated in the observed celebration and expressed kind feelings to the Ukrainian people, recognised their fight for freedom, during the House of Representatives and Senate sessions. Several Congressmen submitted the resolutions in the US Congress urging the President of United States to designate January 22 as «Ukrainian lndependence Day». January 22 was proclaimed Ukrainian Day by the governors of fifteen States and mayors of many cities. Keywords: January 22, Ukrainian independence day, Ukrainian diaspora, USA, interaction, Congress

scholarly journals Trends in educational mobility: How does China compare to Europe and the United States?

2019 ◽  
Vol 5 (2) ◽  
pp. 214-240
Author(s):  
Rob J Gruijters ◽  
Tak Wing Chan ◽  
John Ermisch
Keyword(s):  
Educational Opportunity ◽  
The United States ◽  
International Standards ◽  
Educational Mobility ◽  
The Us ◽  
The Usa ◽  
Economic Boom ◽  
The Uk ◽  
Large Decline ◽  
Inequality Of Educational Opportunity

Despite an impressive rise in school enrolment rates over the past few decades, there are concerns about growing inequality of educational opportunity in China. In this article, we examine the level and trend of educational mobility in China, and compare them to the situation in Germany, the Netherlands, the UK and the USA. Educational mobility is defined as the association between parents’ and children’s educational attainment. We show that China’s economic boom has been accompanied by a large decline in relative educational mobility chances, as measured by odds ratios. To elaborate, relative rates of educational mobility in China were, by international standards, quite high for those who grew up under state socialism. For the most recent cohorts, however, educational mobility rates have dropped to levels that are comparable to those of European countries, although they are still higher than the US level.

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