Policy Updates

The FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least two months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine. Read the FDA … Continued

CMS has revised interpretive guidelines for the hospital Quality Assessment & Performance Improvement (QAPI) Program Conditions of Participation (CoPs). The updated hospital QAPI program interpretive guidance provides an essential tool for surveyors and hospital staff to more consistently focus their evaluation on a hospital’s efforts not only to improve its performance and quality, but also … Continued

As the COVID-19 Public Health Emergency (PHE) approaches its expected expiration on May 11, 2023, the FDA is reviewing all guidance documents related to COVID-19 to determine which will remain in effect, which will expire, and which will be revised when the PHE expires. This notice provides lists of the expected post-PHE status of all … Continued

The FDA alerted healthcare facilities and providers about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set Advanced that contains the oxygenator, heat exchanger, and integrated centrifugal pump. Patients treated with the HLS Set Advanced should be monitored for the following signs and symptoms … Continued

The CDC issued a Health Alert Network (HAN) Health Advisory to notify clinicians and public health officials about a confirmed measles case at a large gathering. On February 24, 2023, the Kentucky Department for Public Health (KDPH) identified a confirmed case of measles in an unvaccinated individual with a history of recent international travel. While … Continued

The CDC issued a Health Alert Network (HAN) Health Advisory to notify clinicians and public health officials about an increase in the number of cases of chikungunya reported in Paraguay. As of February 24, 2023, the Ministry of Health in Paraguay reported a total of 71,478 suspect chikungunya cases in Paraguay, with 29,362 of those being … Continued

The FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab … Continued

The CDC Clinician Outreach and Communication Activity (COCA) group will host a webinar on Tuesday, February 28 about the recent increase in extensively drug-resistant (XDR) Shigella infections (shigellosis). The webinar will help clinicians understand the nuances of testing and managing infections, especially when treating patients from populations at increased risk of drug-resistant shigellosis including: young … Continued

The CDC issued a Health Alert Network (HAN) Health Advisory about an increase in extensively drug-resistant (XDR) Shigella infections (shigellosis) reported through national surveillance systems. In 2022, about 5% of Shigella infections reported to CDC were caused by XDR strains, compared with 0% in 2015. Clinicians treating patients infected with XDR strains have limited antimicrobial treatment options. Shigella bacteria are easily transmissible, … Continued