Guidelines for safety in the gastrointestinal endoscopy unit.

Historically, safety in the gastrointestinal (GI) endoscopy unit has focused on infection control, particularly around the reprocessing of endoscopes. Two highly publicized outbreaks in which the transmission of infectious agents were related to GI endoscopy have highlighted the need to address potential gaps along the endoscopy care continuum that could impact patient safety. In 2009, the Centers for Medicare andMedicaid Services (CMS) Conditions for Coverage eliminated the distinction between a sterile operating room and a non-sterile procedure room. Hence, GI endoscopy units are now held to the same standards as sterile operating rooms by CMS without evidence demonstrating that safety or clinical outcomes in endoscopy are thereby improved. Although the American Society for Gastrointestinal Endoscopy (ASGE) has previously published guidelines on staffing, sedation, infection control, and endoscope reprocessing for endoscopic procedures (Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011; Infection control during GI endoscopy; Minimum staffing requirements for the performance of GI endoscopy; Multisociety sedation curriculum for gastrointestinal endoscopy), the purpose of this document is to present recommendations for endoscopy units in implementing and prioritizing safety efforts and to provide an endoscopy-specific guideline by which to evaluate endoscopy units. As a general principle, requirements for safety ought to be rooted in evidence that demonstrates a benefit in outcomes. When data are absent, these requirements may be derived from experts with experience in the safe delivery of care in the GI endoscopy setting. Additionally, consideration should be given to the promotion of efficient care and cost containment, with avoidance of requirements unsupported by evidence that then contribute to rising healthcare costs.