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CMS says wrap it up before you flash

Last week the Centers for Medicare and Medicaid Services (CMS) released a memo to state survey directors [1] clarifying its position on flash sterilization for ambulatory surgery centers (ASC).

According to the memo, state survey agencies using the new Infection Control Survey Worksheet, have experienced challenges evaluating the use of flash sterilization. The clarification states that, “utilization of a short sterilization cycle of a wrapped/contained load may no longer be a concern so long as the ASC is following ALL manufacturers’ instructions for the devices involved.”

It’s important to remember CMS still considers routine sterilization of unwrapped/uncontained loads a violation of 42 CFR 416.51(a).

Surveyors will ask the following questions to determine if ASC’s are in compliance:

  1. Is the sterilizer labeled for this cycle by the manufacturer?
  2. What is the sterilizer manufacturer-recommended load for that cycle?
  3. Is the containment device used labeled by its manufacturer for use in that cycle?
  4. For what load is the containment device recommended by its manufacturer?
  5. Is the chemical indicator used labeled for use in this cycle by its manufacturer?
  6. If a biological indicator is used is it labeled for use for this cycle by its manufacturer?
  7. If the cycle is used frequently, is it checked regularly with a biological indicator?

This clarification actually allows a bit of freedom for ASC’s, since hospital regulations still do not allow routine flash sterilization, even for wrapped loads.

The problem is many device manufacturer’s may not have specific instructions for flash sterilization, or facilities may not be aware of those instructions. However, without them CMS considers the cycle “guesswork,” indicating a surefire violation.

For those of you still struggling to establish your sterilization program, the first thing you should do is create an inventory of manufacturer’s instructions for all the devices in your facility. For those that  do not address flashing, contact the company to ensure the instructions exist and a copy can be acquired.

Fortunately CMS has made compliance relatively easy by providing the specific survey questions above. Ask yourself these questions to find out what gaps still exist in your program.

For more information on meeting CMS Conditions of Coverage see this previous posts by Libby Chinnes here [2], and here [3]. You may also want to review our “Sterilization FAQs [4],” and the “Sterilization expectations from the Joint Commission [5].”

For additional IC training, the Infection Prevention Core Training Bundle [6] is a comprehensive three-part Webcast series available on-demand. The bundle focuses specifically on IC best practices, and provides training for existing employees or those new to the field of infection control.