Policy Updates

9/28/22 — The FDA issued a warning letter jointly with the Federal Trade Commission to Bespoke Apothecary LLC for selling unapproved and misbranded COVID kit and Post Virus Recovery Herbal Tea products as drugs for use in treating or preventing COVID-19. 

6/3/22 — CMS issued updated surveyor guidance for ambulatory surgical centers that included a clarification related to reporting of infection control breaches that could potentially expose patients to the blood or bodily fluids of another. Read QSO-22-16-ASC (see Infection Control Sec. 416.51).

8/22/22 — The CMS Center for Medicaid and CHIP Services (CMCS) provided an informational bulletin to notify nursing facilities that Medicaid funds may be used to improve healthcare quality and equity. The bulletin described actions states can implement using existing Medicaid authority to improve care quality, accountability, staffing, safety, and emergency preparedness in nursing care. Among … Continued

8/24/22 — The FDA is informing healthcare providers and patients of the potential risk of transmission of monkeypox virus through fecal microbiota for transplantation (FMT) products. Due to the potential for serious adverse events to occur, FDA has determined that additional protections are needed for any investigational use of FMT, whether used as part of … Continued

NHSN will assume responsibility for collection of COVID-19 hospital data mid-December 2022. No change in reporting is required at this time. CDC will communicate actions needed to prepare for the transition to NHSN users and COVID-19 reporters and discussed in scheduled webinars. CDC/NHSN has established a transition web page to provide important updates, upcoming trainings, and next steps. We … Continued

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples. Read the FDA recall notice.

The CDC recently updated its COVID-19 testing guidance to recommend that if someone has had exposure to a person with COVID-19 and is asymptomatic, but has had COVID-19 within the past 30 days, testing to identify a new infection is generally not recommended. If someone has become newly symptomatic after having had COVID-19 within the … Continued

North American Diagnostics is recalling Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they were distributed without authorization, clearance, or approval from the FDA. North American Diagnostics did not provide the FDA with adequate validation data to show that the test’s performance is accurate. Use of these test kits may cause serious adverse health consequences … Continued

CDC update 8/22/22 — The CDC will hold a webinar to update public health partners on its monkeypox response on Thursday, August 25 at 1:00 – 1:45 pm ET. Click here for Zoom link.  The CDC is also continually updating its monkeypox guidance. Click here for CDC’s key messages on monkeypox. In addition, here are links to recently … Continued