06/30/2020 12:00 AM EDT
Source: Office of the Assistant Secretary for Preparedness and Response [U.S. Department of Health and Human Services] (HHS ASPR). Published: 6/30/2020. This 227-page toolkit, updated on June 30, 2020, was developed to help state, local, tribal, and territorial (SLTT) entities address potential capacity and capability gaps in healthcare systems during the 2020 SARS-CoV-2 virus (COVID-19) pandemic. It is intended to provide medical operations guidance and technical assistance to SLTT entities in establishing and operationalizing an ACS used to care for COVID-19-positive patients, presumed COVID-19-positive patients, and/or non-COVID-19 patients in a mixed setting. (PDF)
06/30/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/30/2020. This 24-page guidance was issued to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19, and describes the FDA’s current recommendations regarding the data needed to facilitate clinical development and licensure of vaccines to prevent COVID-19. (PDF)
06/30/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/30/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Psoma COVID-19 RT Test that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. (PDF)
06/30/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/30/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit. The COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit is authorized for use with respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider. (PDF)
06/30/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/30/2020. This seven-page letter authorizes the use of this home collection kit by individuals to self-collect nasal swab specimens at home, video-observed by a heathcare provider, when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-CoV-2 RNA that are indicated for use with the Kroger Health COVID-19 Test Home Collection Kit. (PDF)
06/30/2020 12:00 AM EDT
Source: Centers for Disease Control and Prevention, Office of Infectious Diseases (CDC OID). Published: 6/30/2020. This web page provides COVID-19 resources for the Centers for Disease Control and Prevention's global partners, including resources for Healthcare Services and Workers, Community Mitigation Framework, Emergency Response, Surveillance, and Migration and Border Health. (Text)
06/30/2020 12:00 AM EDT
Source: Centers for Disease Control and Prevention, Office of Infectious Diseases (CDC OID). Published: 6/30/2020. Schools should determine, in collaboration with state, tribal, territorial, and local health officials, and, in the case of K-12 schools operated by the federal government (e.g., K-12 schools for Department of Defense Dependents) appropriate federal health officials, whether to implement any COVID-19 testing strategy, and if so, how to best do so. These considerations are meant to supplement—not replace—any federal, state, local, territorial, or tribal health and safety laws, rules, and regulations with which schools must comply. (Text)
06/30/2020 12:00 AM EDT
Source: Centers for Disease Control and Prevention, Office of Infectious Diseases (CDC OID). Published: 6/30/2020. As some institutions of higher education (IHEs) open in the United States, the CDC offers considerations for ways in which IHEs can help protect students, faculty, and staff and slow the spread of the coronavirus disease 2019 (COVID-19). These CDC considerations are meant to supplement—not replace—any federal, state, local, territorial, or tribal health and safety laws, rules, and regulations with which IHEs must comply. (Text)
06/29/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/29/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Acupath COVID-19 Real-Time (RT-PCR) Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. (PDF)
06/29/2020 12:00 AM EDT
Source: Agency for Healthcare Research and Quality [U.S. Department of Health and Human Services] (AHRQ). Published: 6/29/2020. This web page discusses how the COVID-19 pandemic and the response of the healthcare system have affected the ability of pharmacists to ensure medication safety in several ways, and provides resources to respond to challenges. The response includes challenges associated with medication shortages, changes to the pharmacy workflow, an ever-changing evidence base associated with the pharmaceutical treatment of COVID-19 complications, and limited availability of personal protective equipment (PPE). (Text)
06/26/2020 12:00 AM EDT
Source: Office of the Assistant Secretary for Preparedness and Response [U.S. Department of Health and Human Services] (HHS ASPR). Published: 6/26/2020. This six-page document responds to a request for resources regarding staffing shortages, unemployment numbers, suicide attempts, behavioral healthcare shortages, and any economic impacts related to recent disasters. (PDF)
06/25/2020 12:00 AM EDT
Source: Centers for Disease Control and Prevention, Office of Infectious Diseases (CDC OID). Published: 6/25/2020. This web page, updated on June 25, 2020, has been updated and reorganized according to core infection prevention and control practices that should remain in place even as nursing homes resume normal practices during the COVID-19 pandemic, plus additional strategies depending on the stages described in the CMS Reopening Guidance or at the direction of state and local officials. (Text)
06/23/2020 12:00 AM EDT
Source: Office of the Assistant Secretary for Preparedness and Response [U.S. Department of Health and Human Services] (HHS ASPR). Published: 6/23/2020. This six-page document was written in response to a request for best practices and examples from state and local health departments on how they selected COVID-19 testing sites in Hispanic communities, what partners they worked with to reach those residents, how they established community partnerships, and what they considered to be the most successful communication platforms (e.g., social media, radio, television, print). (PDF)
06/15/2020 12:00 AM EDT
Source: Henry J. Kaiser Family Foundation. Published: 6/15/2020. This report uses the National Health Information Survey (NHIS) to look at how many adult workers are at increased risk of severe illness if infected with coronavirus, based on risk factors identified by the Centers for Disease Control and Prevention (CDC). These risk factors include having diabetes, chronic obstructive pulmonary disease (COPD), heart disease, a body mass index (BMI) above 40, moderate to severe asthma, and a functional limitation due to cancer. It finds that over 90 million adults are at greater risk for severe illness from COVID-19 due to underlying health conditions or age. (Text)
06/08/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/8/2020. This nine-page guidance was issued to address questions the FDA has received asking for clarification regarding FDA’s enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency (PHE). (PDF)
06/02/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 6/2/2020. This eight-page guidance was issued to provide recommendations regarding the key factors and procedures that institutional review boards (IRBs) should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19. (PDF)
06/01/2020 12:00 AM EDT
Source: Centers for Disease Control and Prevention, Center for Preparedness and Response (CDC CPR). Published: 6/2020. This eight-page report presents an analysis of the Federal Select Agent Program (FSAP)’s responsiveness in providing feedback, via inspection reports, to FSAP-registered entities after on-site inspections during calendar year (CY) 2019. FSAP uses this data to improve program performance in providing timely feedback to registered entities that have received an on-site inspection. (PDF)
06/01/2020 12:00 AM EDT
Source: American Academy of Pediatrics (AAP). Published: 6/2020. The purpose of this guidance is to support education, public health, local leadership, and pediatricians collaborating with schools in creating policies for school re-entry during the COVID-19 pandemic that foster the overall health of children, adolescents, staff, and communities, and are based on available evidence. It strongly advocates that all policy considerations for the coming school year should start with a goal of having students physically present in school. (Text)
05/18/2020 12:00 AM EDT
Source: County Health Rankings & Roadmaps. Published: 5/18/2020. This web page provides information and links for a webinar series that highlights the challenges communities are facing as they respond to COVID-19 and its impacts, and will serve as an opportunity for community leaders across the nation to learn from lead researchers, policymakers, and each other. (Video or Multimedia)
05/15/2020 12:00 AM EDT
Source: U.S. Department of Health and Human Services (HHS). Published: 5/15/2020. In light of the nationwide public health emergency and national emergency for COVID-19, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services provides this four-page bulletin to health entities covered by OCR’s civil rights authorities to ensure they are better able to serve individuals with limited English proficiency (LEP). (PDF)
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