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REGULATORY REVIEW


removal from the sterilizer and its asep- tic transfer to the sterile field. A steril- ized item intended for immediate use is not stored for future use, nor held from one case to another. IUSS must not be a routine or frequent practice in the ASC, but as noted in the previous memo on this topic, IUSS is not equiv- alent to “short cycle” sterilization per- formed in accordance with manufac- turers’ instructions for use (IFUs). As long as the product requires some dry time and the sterilized items are stored for future use, the definition of IUSS is not met. Still, this change is having a huge financial impact on many facil- ities, as some ASCs had previously been using sterilization techniques that would now fall under the definition of IUSS because there was no dry time at all and the products were not stored for future use. Please also note that if the manufacturer does not provide IFUs, the facility must have “evidence-based guidelines” indicating that the product


meets current requirements. It would be expected that the surgery center would include this documentation in a log of some kind.


Point of Care Testing Devices Finally, CMS has made changes to the language under Part V, Point of Care


Devices. It added language to indi- cate that CMS will be observing if “hand hygiene is performed before and after performing a finger stick proce- dure to obtain a sample of blood and using the point-of-care testing device,” and checking that “gloves are worn by health care personnel when perform- ing a finger stick procedure to obtain a sample of blood, and are removed after the procedure (followed by hand hygiene).” CMS also notes that “fin- ger stick devices are not used for more than one patient.” Keep in mind that if the surveyor cannot observe these practices, the expectations will be to see policies and interview staff to determine that these practices are being accomplished. Although these are practices that are being done daily in your ASCs, this is the first time the IC worksheet specifies that survey- ors should be evaluating you on them. Please make sure your facilities pol- icies and procedures are updated to reflect all of these requirements. It would be advisable to have at least all clinical staff at your facility read the new IC worksheet. Educational in-servicing can also be conducted and documented so that the state surveyors can verify that staff was informed of these changes. While many of these infection prevention practices may be ones implemented in your facility long ago, it is important to make sure that all of your policies and procedures reflect this fact. When CMS makes changes to its guidance as it recently did in the IC worksheet, it provides a good opportunity for ASCs to review facility documentation.


Sandra A. Berreth, RN, CASC, is an ASCA Board member and a Medicare surveyor for the Accreditation Association for Ambulatory Health Care. Write her at s.berreth23@gmail.com.


26 ASC FOCUS NOVEMBER/DECEMBER 2015


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