scholarly journals Development of National Newborn Screening Quality Indicators in the United States

2019 ◽  
Vol 5 (3) ◽  
pp. 34 ◽  
Author(s):  
Careema Yusuf ◽  
Marci K. Sontag ◽  
Joshua Miller ◽  
Yvonne Kellar-Guenther ◽  
Sarah McKasson ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
Newborn Screening ◽  
Quality Indicators ◽  
Technical Assistance ◽  
The United States ◽  
Iterative Refinement ◽  
Data Repository ◽  
Screening System ◽  
Screening Process

Newborn screening is a public health program facilitated by state public health departments with the goal of improving the health of affected newborns throughout the country. Experts in the newborn screening community established a panel of eight quality indicators (QIs) to track quality practices within and across the United States newborn screening system. The indicators were developed following iterative refinement, consensus building, and evaluation. The Newborn Screening Technical assistance and Evaluation Program (NewSTEPs) implemented a national data repository in 2013 that captures the quality improvement metrics from each state. The QIs span the newborn screening process from collection of a dried blood spot through medical intervention for a screened condition. These data are collected and analyzed to support data-driven outcome assessments and tracking performance to improve the quality of the newborn screening system.

scholarly journals Landscape of Congenital Adrenal Hyperplasia Newborn Screening in the United States

2020 ◽  
Vol 6 (3) ◽  
pp. 64
Author(s):  
Sari Edelman ◽  
Hiral Desai ◽  
Trey Pigg ◽  
Careema Yusuf ◽  
Jelili Ojodu
Keyword(s):  
United States ◽  
At Risk ◽  
Congenital Adrenal Hyperplasia ◽  
Newborn Screening ◽  
Technical Assistance ◽  
The United States ◽  
Data Repository ◽  
Adrenal Hyperplasia ◽  
Permanent Disability ◽  
Specific Disorders

Newborn screening (NBS) is a state-based public health program that aims to identify newborns at risk of certain disorders in the first days after birth to prevent permanent disability or death. Disorders on the Health and Human Services Federal Advisory Committee’s Recommended Uniform Screening Panel (RUSP) have been adopted by most state NBS programs; however, each state mandates specific disorders to be screened and implements their own system processes. Congenital adrenal hyperplasia (CAH) was added to the RUSP in 2005, and currently all 53 NBS programs universally screen for it. This paper provides a landscape of CAH screening in the United States, utilizing data voluntarily entered by state NBS programs in the Newborn Screening Technical assistance and Evaluation Program data repository. Data reported encompasses NBS state profile data (follow-up, disorder testing and the reporting of processes and methodologies for screening), quality indicator data (timeliness of CAH NBS) and confirmed cases. This comprehensive landscape analysis compares the CAH NBS systems across the US. This is vital in ultimately ensuring that newborns with CAH at risk of salt crisis receive appropriate intervention in a timely manner.

scholarly journals Expanding Newborn Screening for Pompe Disease in the United States: The NewSTEPs New Disorders Implementation Project, a Resource for New Disorder Implementation

2020 ◽  
Vol 6 (2) ◽  
pp. 48
Author(s):  
Kshea Hale ◽  
Yvonne Kellar-Guenther ◽  
Sarah McKasson ◽  
Sikha Singh ◽  
Jelili Ojodu
Keyword(s):  
Public Health ◽  
United States ◽  
Newborn Screening ◽  
Pompe Disease ◽  
Technical Assistance ◽  
Genetic Disorders ◽  
Health Resources ◽  
The United States ◽  
Lessons Learned ◽  
Implementation Project

Public health programs in the United States screen more than four million babies each year for at least 30 genetic disorders. The Health and Human Services (HHS) Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) recommends the disorders for state newborn screening (NBS) programs to screen. ACHDNC updated the Recommended Uniform Screening Panel (RUSP) to include Pompe disease in March 2015. To support the expansion of screening for Pompe disease, the Association of Public Health Laboratories (APHL) proposed the Newborn Screening Technical assistance and Evaluation Program (NewSTEPs) New Disorders Implementation Project, funded by the HHS’ Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau (MCHB). Through this project, APHL provided financial support to 15 state NBS programs to enable full implementation of screening for Pompe disease. As of April 27, 2020, nine of the 15 programs had fully implemented Pompe disease newborn screening and six programs are currently pursuing implementation. This article will discuss how states advanced to statewide implementation of screening for Pompe disease, the challenges associated with implementing screening for this condition, the lessons learned during the project, and recommendations for implementing screening for Pompe disease.

scholarly journals Establishing a National Community of Practice for Newborn Screening Follow-Up

2021 ◽  
Vol 7 (3) ◽  
pp. 49
Author(s):  
Erin Darby ◽  
John Thompson ◽  
Carol Johnson ◽  
Sikha Singh ◽  
Jelili Ojodu
Keyword(s):  
Public Health ◽  
Newborn Screening ◽  
Community Of Practice ◽  
Resource Sharing ◽  
Information Dissemination ◽  
Technical Assistance ◽  
State Level ◽  
The United States ◽  
National Community

Newborn screening (NBS) follow-up programs in the United States are managed at the state level, leaving limited opportunities for collaboration across programs and coordinated resource sharing. The Newborn Screening Technical assistance and Evaluation Program (NewSTEPs), a program of the Association of Public Health Laboratories (APHL), has established a national community of practice for NBS follow-up by creating a network of follow-up staff and stakeholders through education and engagement opportunities. The activities of NewSTEPs in support of NBS follow-up have strengthened information dissemination, collaboration, data collection and technical assistance-driven mentorship across the national system.

scholarly journals Newborn Screening Practices for Beta-Thalassemia in the United States

2021 ◽  
Vol 7 (4) ◽  
pp. 83
Author(s):  
Michael A. Bender ◽  
Mary Hulihan ◽  
Mary Christine Dorley ◽  
Maria del Pilar Aguinaga ◽  
Jelili Ojodu ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
Newborn Screening ◽  
Thalassemia Major ◽  
Health Impact ◽  
The United States ◽  
Beta Thalassemia ◽  
Screening Methods ◽  
Beta Thalassemia Major

Beta-thalassemia, a heritable condition of abnormal hemoglobin production, is not a core condition on the United States Recommended Uniform Screening Panel (RUSP) for state and territorial newborn screening (NBS) programs. However, screening for sickle cell disease (which is on the core RUSP) also detects reduced or absent levels of hemoglobin (Hb) A and certain other Hb variants associated with beta-thalassemia and, thus, allows for a timely referral to appropriate healthcare to minimize sequalae of the disease. The Association of Public Health Laboratories’ Hemoglobinopathy Workgroup administered a comprehensive survey of all U.S. NBS programs to assess beta-thalassemia testing methodologies, the cutoffs for defining beta-thalassemia major, and the reporting and follow-up practices. Forty-six (87%) of the programs responded. Thirty-nine of the 46 responding programs (85%) report some form of suspected beta-thalassemia; however, the screening methods, the percentage of Hb A used as a cutoff for an indication of beta-thalassemia major, and the screening follow-up vary widely. The standardization of technical and reporting procedures may improve access to specialty care prior to severe complications, increase genetic counseling, and provide data needed to better understand the public health impact and clinical outcomes of beta-thalassemia in the United States.

Can increases in Twitter posts predict increases in cumulative incidence of COVID-19 in the United States? Evidence that social media can inform epidemic surveillance. (Preprint)

2020 ◽  
Author(s):  
Ruoyan Sun ◽  
Henna Budhwani
Keyword(s):  
Public Health ◽  
United States ◽  
Cumulative Incidence ◽  
Hot Spots ◽  
Adult Population ◽  
State Level ◽  
The United States ◽  
Education Attainment ◽  
Public Health Systems ◽  
Per Capita

BACKGROUND Though public health systems are responding rapidly to the COVID-19 pandemic, outcomes from publicly available, crowd-sourced big data may assist in helping to identify hot spots, prioritize equipment allocation and staffing, while also informing health policy related to “shelter in place” and social distancing recommendations. OBJECTIVE To assess if the rising state-level prevalence of COVID-19 related posts on Twitter (tweets) is predictive of state-level cumulative COVID-19 incidence after controlling for socio-economic characteristics. METHODS We identified extracted COVID-19 related tweets from January 21st to March 7th (2020) across all 50 states (N = 7,427,057). Tweets were combined with state-level characteristics and confirmed COVID-19 cases to determine the association between public commentary and cumulative incidence. RESULTS The cumulative incidence of COVID-19 cases varied significantly across states. Ratio of tweet increase (p=0.03), number of physicians per 1,000 population (p=0.01), education attainment (p=0.006), income per capita (p = 0.002), and percentage of adult population (p=0.003) were positively associated with cumulative incidence. Ratio of tweet increase was significantly associated with the logarithmic of cumulative incidence (p=0.06) with a coefficient of 0.26. CONCLUSIONS An increase in the prevalence of state-level tweets was predictive of an increase in COVID-19 diagnoses, providing evidence that Twitter can be a valuable surveillance tool for public health.

Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA

2021 ◽  
pp. 174113432110235
Author(s):  
Chandan Saini ◽  
Ashish Miglani ◽  
Pankaj Musyuni ◽  
Geeta Aggarwal
Keyword(s):  
Public Health ◽  
United States ◽  
Regulatory Authority ◽  
The United States ◽  
Federal Law ◽  
Pharmaceutical Manufacturers ◽  
The World ◽  
Considerable Impact ◽  
A Company ◽  
Responsible Person

Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.

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