Public Policy Updates

March 30: CMS has issued enhanced enforcement policy for infection control deficiencies (QSO-20-31-ALL) with revisions focusing on severe and actual harm levels. This refocused enforcement will increase civil monetary penalties, shorten notice for discretionary denial of payment for new admissions, and require the directed plans of correction to include hiring an external infection control consultant … Continued

The FDA issued two guidance documents to help prepare medical device manufacturers, distributors, healthcare facilities and providers, and other stakeholders through the expiration of the COVID-19 Public Health Emergency (PHE). The two guidance documents are: “Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” and “Transition Plan … Continued

The U.S. Government Accountability Office (GAO) released a report identifying actions to improve infection prevention and control practices in nursing homes. The report is based on recommendations of a panel of infectious disease specialists, nursing home staff and other experts convened by GAO to examine infection control practices in nursing homes. Many of the actions … Continued

APIC has developed a survey to help us quantify IP challenges with medical device instructions for use (IFUs). Your response will help us better serve the needs of our members and inform U.S. regulatory agencies of these challenges. Please respond to the survey by April 11. Respondents should be currently practicing IPs in a healthcare … Continued

The CDC published updated and expanded recommendations for screening and testing for chronic hepatitis B virus infection. New recommendations include hepatitis B screening using three laboratory tests at least once during a lifetime for adults aged 18 and older. The report also expands risk-based testing recommendations for certain populations. Read the new recommendations.

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