In a letter from the Centers for Medicare and Medicaid Services (CMS) to state survey agency directors, the agency spells out changes to the Ambulatory Surgical Center Infection Control Surveyor Worksheet and its Manual Instructions for areas including artificial fingernails and immediate use steam sterilization. New CMS wording on artificial fingernails says, “Personnel providing direct patient care do not wear artificial fingernails and/ or extenders when having direct contact with patients.”
Marcia Patrick, MSN, RN, CIC, a surveyor for the Accreditation Association for Ambulatory Health Care and a consultant in infection prevention, based in Tacoma, WA, was “thrilled” to see this change. “That particular piece is long overdue,” Patrick says. “We know from studies that people with false nails grow a huge, much broader range of bacteria, as well as many, many more times the number of organisms than short natural nails.”
Now facilities have federal clout to put behind regulations prohibiting their use, she says.
CMS also made changes to requirements concerning immediate-use steam sterilization, or what formerly was referred to as “flash” sterilization. “They’re very, very specific on how to do that,” Patrick says. “That’s another very good clarification.”
Here are the CMS changes:
Is immediate-use steam sterilization (IUSS) performed on-site? If IUSS is performed, all of the following criteria are met:
- Work practices ensure proper cleaning and decontamination, inspection, and arrangement of the instruments into the recommended sterilizing trays or other containment devices before sterilization.
- Once clean, the item is placed within a container intended for immediate use. The sterilizer cycle and parameters used are selected according to the manufacturers’ instructions for use for the device, container, and sterilizer.
- The sterilizer function is monitored with monitors (e.g., mechanical, chemical and biologic) that are approved for the cycle being used.
- The processed item must be transferred immediately, using aseptic technique, from the sterilizer to the actual point of use, the sterile field in an ongoing surgical procedure.
Note: “Immediate use” is defined as the shortest possible time between a sterilized item’s removal from the sterilizer and its aseptic transfer to the sterile field. A sterilized item intended for immediate use is not stored for future use, nor held from one case to another. IUSS is not equivalent to “short cycle” sterilization performed in accordance with manufacturers’ IFUs. IUSS must not be a routine or frequent practice in the ASC.
Immediate-use steam sterilization is NOT performed on the following devices:
- Post-procedure decontamination of instruments used on patients who may have Creutzfeldt-Jakob disease or similar disorders.
- Devices that have not been validated with the specific cycle employed.
- Single-use devices that are sold sterile.
Is IUSS performed on a routine basis? (A “Yes” answer must be cited as a deficient practice in relation to 42 CFR 416.51(a).
A final change from CMS involves chemical indicators:
A chemical indicator (process indicator) is placed correctly, as described in manufacturer’s instructions for use, in the instrument packs in every load. A biological indicator is used at least weekly for each sterilizer and with every load containing implantable items, as evidenced by ASC documentation (i.e., log).