Public Policy Updates

The FDA issued an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of … Continued

QSO-20-38-NH, revised on September 23, 2022, updates the CMS requirement originally released in August 2020 requiring COVID-19 testing for all staff and residents in Long-Term Care (LTC) facilities. The revised rule no longer recommends routine testing of asymptomatic staff, but such testing may be performed at the discretion of the facility. The guidance also includes … Continued

10/6/22 — The CDC issued a Health Alert Network (HAN) Health Advisory to alert clinicians and health departments about an outbreak of Ebola virus disease (EVD) in Central Uganda. As of October 6, no suspected, probable, or confirmed cases related to this outbreak have been reporting in the U.S. or other countries outside of Uganda. … Continued

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.