CMS Revises ASC Infection Control Surveyor Worksheet:
Critical Changes to Know

By Phenelle Segal, ASC Infection Control Consultant and President of Infection Control Consulting Services

On June 26, 2015, the Centers for Medicare & Medicaid Services (CMS) released an update to the Ambulatory Surgical Center Infection Control Surveyor Worksheet (ICSW), which is used by federal and state surveyors to determine infection control Conditions for Coverage (CfC) compliance. This worksheet has been used since 2009, and was last revised in 2012.

CMS has released this update for the purpose of bringing the worksheet into alignment with current accepted standards of practice and recently released guidance. Improving the clarity of questions is an additional goal.

While CMS states this is an "advanced update" with a final copy to be "published at a later date," the memorandum stipulates that these changes are "effective immediately." After contacting CMS, they assured me that while there may be formatting or slight wording changes between the memo release and the official update to the online State Operations Manual, the content will not change.

For the past five years, I have been conducting ASC onsite visits and consistently use the worksheet to determine "best practices." Given the recent issues relating to improper disinfection of duodenoscopes, ongoing issues with safe injection practices, areas of confusion such as artificial nails in the direct care setting and other breaches that I continue to observe during my onsite visits, I assume the results of my observations are similar to those of the federal and state surveyors throughout the country (I have spoken with many surveyors who said they made similar observations). This may be, in part, what prompted CMS to make these changes to the existing survey worksheet.

Several changes, some of them in-depth, have been made in a number of clinical categories. The updates will require review and re-education of staff who are directly involved in patient care as well as staff who are responsible for infection prevention and control.

The changes relate to Part 2 of the worksheet — Infection Control Related Practices — and include the following significant revisions:

1. A separate column with instructions for surveyor's notes has been added to the worksheet.

2. "Unable to observe" has been added to the response categories.

3. An instruction for increased document and policy/procedure review has been added, particularly if a practice is not observed. I have noticed over the course of the past few years, especially when assisting facilities with corrective action plans after they have received deficiencies, that surveyors are paying closer attention to written documentation, so this is not an unexpected addition.

4. Hand hygiene section now includes the following:

•      "Readily accessible, in appropriate location" when referring to products availability such as soap, water and alcohol sanitizer.

•      "Personnel providing direct patient care do not wear artificial fingernails and/or extenders when having direct contact with patients."

5. Several updates to "injection practices," including the following:

•      Statement addressing reporting of "unsafe medicine practices" to the state's public health authority if surveyor evidence suggests breaches.

Syringes are used for only one patient (this includes manufactured prefilled syringes).

•      Alcohol cleaning of the rubber septum before entering a multi-dose vial has been an area of confusion on an ongoing basis. The change stipulates that "the rubber septum on a medication, whether unopened or previously accessed, vial is disinfected with alcohol prior to piercing."

•      "Beyond use date" has been added to the practice of labeling pre-drawn medications.

•      Bags of IV solutions are used for only one patient (and not as a source of flush solution for multiple patients).

•      The following practice, while stated as voluntary, has not appeared in prior versions of the worksheet: "The ASC has voluntarily adopted a policy that medications labeled for multi-dose use for multiple patients are nevertheless only used for one patient."

•      Multi-dose vials used for more than one patient must be stored appropriately and do not enter the "immediate patient care area; and if they enter the area, they must be dedicated as single use and discarded immediately after."

6. The section on sterilization has several additions, including the following:

•      Pre-cleaning and disinfection refer to processes "specified by manufacturer's instructions or, if the manufacturer does not provide instructions, evidence-based guidelines." I interpret this to mean that if the manufacturer provides instructions for these processes, the facility is obligated to follow them, but if they are not provided, then the facility is obligated to follow evidence-based guidelines.

•      A detailed and in-depth subsection on immediate-use steam sterilization (IUSS).

•      A detailed addition for sterilizer monitoring with chemical and biological indicators.

7. A minor update to environmental infection control: "Environmental surfaces in patient care areas are cleaned and disinfected, using an EPA-registered disinfectant on a regular basis (e.g., daily), when spills occur and when surfaces are visibly contaminated."

8. A comprehensive update of "point of care devices" which added in several steps.

Have Questions?

The changes I have identified here are some of what I view as the most significant, but there are a number of additional changes in the ICSW that ASCs need to review and understand. If you have any questions about the revised worksheet and how it may affect your ASC, please contact me by filling out the form here, emailing or calling (215) 692-3485.