CMS’ Interpretive Guidance for Nursing Homes on Reprocessed Single-Use Devices and Egg Preparation
July 21, 2014
July 21, 2014
The Centers for Medicare and Medicaid Services (CMS) recently issued interpretive guidance in two areas of interest for nursing homes: use of reprocessed single-use devices and preparation of eggs in nursing homes. Nursing homes should become familiar with these guidance documents to avoid survey deficiencies.
CMS revised its guidance regarding use of single-use devices: S&C Memorandum No. 14-25-NH, “Advance Copy — Single Use Device Reprocessing under Tag 441, Revisions to Interpretative Guidance in Appendix PP, State Operation Manual (SOM) on Infection Control,” issued May 9, 2014. CMS made this revision to be consistent with current Food and Drug Administration (FDA) regulation that allows the reprocessing and marketing of single-use devices under specific conditions. 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 FDA. CMS states that the nursing home must have documentation from the third-party reprocessor indicating that it has been cleared by the FDA to reprocess the specific device in question.
CMS also has revised its interpretative guidance and procedures relating to egg preparation in nursing homes: S&C Memorandum No. 14-34-NH, “Advance Copy of Revised F371; Interpretive Guidance and Procedures for Sanitary Conditions, Preparation of Eggs in Nursing Homes,” issued May 20, 2014. Nursing homes should use pasteurized shell eggs or liquid pasteurized eggs to eliminate the risk of residents contracting Salmonella Enteritidis. Using pasteurized eggs allows nursing homes to meet resident preferences for soft-cooked, undercooked, or sunny-side up eggs. CMS has stated that nursing homes should not prepare or serve soft-cooked, undercooked, or sunny-side up eggs from unpasteurized eggs. Unpasteurized eggs must be cooked until the yolk and the white are completely firm. For all other forms of egg preparation, including hot holding of eggs and eggs used as an ingredient before baking (such as in cakes or meat loaf), the nursing home must use pasteurized eggs or cook the food item to an internal temperature of 160 degrees.
Nursing homes should also take note of guidance issued to surveyors relating to egg preparation. Signed health release agreements between the resident (or the resident’s representative) and the facility acknowledging that the resident has accepted the risk of eating undercooked unpasteurized eggs are not permitted. Thus, if the nursing home prepares or serves unpasteurized or undercooked eggs — eggs that do not have a completely firm yolk and white — CMS has instructed surveyors to consider citing deficiencies at F371.