CMS Revises Infection Control Guidance for F441

Nancy Leveille and Karen Morris in Clinical & Quality

AHCA notified us today of the following CMS update and S&C letter.

CMS has issued revised surveyor guidance at F441. It is posted on the CMS website at:

According to the S&C Memo Summary:

  • Advance Copy: The guidance under Tag F441, Infection Control, Preventing Spread of Infection/Indirect Transmission has been revised.
  • Single-Use Device Guidance: Nursing homes may purchase reprocessed single-use devices when these devices are reprocessed by an entity or a third party re-processor that is registered with the Food and Drug Administration.
  • Single-Use Device (SUD): A SUD is a device that is intended for one use on a single patient during a single procedure.
  • Reprocessed SUD: A reprocessed SUD is an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient.

Per the memorandum this guidance is “advance” guidance and is effective immediately.

  NYSHFA CONTACTS: Nancy Leveille, RN, MS
Sr. Director, Member Operational Support
518-462-4800 x20
  Karen Morris, RN, MS
Director, Clinical & Quality Services
518-462-4800 x15