CMS Issues Revised Surveyor Guidance at F441

Hayden Parker

CMS has issued revised surveyor guidance at F441. It is posted on the CMS website at:  http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-25.html

 

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 reprocessor 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.