2015-04-22 14:37:35 UTC

CMS Announces New Surveyor Requirements Impacting Endoscopes

April 22, 2015

CMS has released new instructions for surveying the reprocessing of duodenoscopes in light of recent outbreaks of CRE infections.

The CMS Center for Clinical Standards and Quality/Survey & Certification Group issued an alert on related to outbreaks of Carbapenem-resistant enterobacteriaceae (CRE) during GI endoscopy, particularly ERCP. The memo contains new instructions for all survey and certification staff when surveying hospitals, critical access hospitals (CAHs) and ambulatory surgical centers (ASCs).

Surveyors are now required to ask during the entrance conference whether duodenoscopes are used. If the answer is yes, then surveyors must request a copy of the manufacturer’s instructions for use for the duodenoscope(s), as well as any automated endoscope reprocessors, the facility uses in reprocessing duodenoscopes. Further, surveyors must observe endoscopes being reprocessed and should ask the responsible staff to demonstrate and explain how they are adhering to manufacturers’ instructions and the multisociety guidance recommendations. Hospitals, CAHs and ASCs must also follow the FDA Recommendations for Facilities and Staff that Reprocess ERCP Duodenoscopes. Any noncompliance identified by surveyors must be cited accordingly, and the increased risk to patient safety resulting from improper reprocessing taken into consideration when determining the appropriate level of citation. 

While the new policy took effect immediately upon the memo’s release on April 2, CMS will allow 30 days for the memo to be communicated to survey and certification staff, their managers, and the state/regional office training coordinator. 

Learn more about what AGA is doing to stop duodenoscope infections.

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