On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that, effective immediately, it is temporarily postponing routine facility inspection and focusing on infection control and situations involving Immediate Jeopardy (where patient safety is placed in imminent danger). CMS is rolling out a new focused survey and inspection process to assess whether facilities are prepared for COVID-19, and has published a fact sheet describing the initiative. This will apply to inspections of all Medicare and Medicaid certified provider and supplier types across the country, such as long term care facilities (nursing homes), hospitals, and CLIA laboratories.
Continue Reading CMS Announces Targeted Plan for Healthcare Facility Inspections in Light of COVID-19

On March 2, 2017, U.S. Food and Drug Administration (FDA) announced that the United States had reached an agreement with the European Union (EU) that will allow FDA and EU regulators to use each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.  The agreement, entered into after several years of joint collaboration and