The American Society for Gastrointestinal Endoscopy (ASGE) has issued "Guidelines for safety in the gastrointestinal endoscopy unit." The purpose of this new guideline 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. The guideline is published on the website of GIE: Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of ASGE, at http://www.giejournal.org.
Historically, safety in the gastrointestinal (GI) endoscopy unit has focused on infection control, particularly around the reprocessing of endoscopes. Although ASGE has previously published guidelines on staffing, sedation, infection control, and endoscope reprocessing for endoscopic procedures, rare reports of outbreaks in which the transmission of infectious agents were related to GI endoscopy have highlighted the need to address potential areas in the endoscopy care continuum that could impact patient safety.
Changes to the Centers for Medicare and Medicaid Services (CMS) Ambulatory Surgical Center Conditions for Coverage that went into effect in 2009 eliminated the distinction between a sterile surgical room and a non-sterile procedure room, providing further impetus for this guideline. As a result of these conditions, non-sterile procedure environments, including endoscopy units, are now held to the same standards as sterile operating rooms even though requirements for facilities, infection control, staffing, and sedation applicable to the sterile operating room may not be relevant or necessary for endoscopy units. To date, the Association of Perioperative Registered Nurses and other organizations have set standards for sterile operating environments. ASGE's new guideline is endorsed by organizations with specific expertise in the safe delivery of care in the non-sterile, GI endoscopy environment, which recognize the important distinction between the endoscopy and sterile operating room settings.
"Over the past two years, surveyors have called into question accepted practices at many accredited endoscopy units seeking reaccreditation. Many of these issues relate to the Ambulatory Surgical Center Conditions for Coverage set forth by CMS and the lack of distinction between the sterile operating room and the endoscopy setting," said Audrey H. Calderwood, MD, co-chair, ASGE Ensuring Safety in the Gastrointestinal Endoscopy Unit Task Force. "ASGE recognized a need to develop nationally-recognized guidelines for endoscopy units that provide recommendations for the implementation and prioritization of safety efforts within GI endoscopy. These endoscopy-specific guidelines will also serve as an important resource for surveyors tasked with evaluating endoscopy units."
"Guidelines for safety in the gastrointestinal endoscopy unit" contains a summary of issues that have been faced by endoscopy units throughout the country along with the ASGE position and accompanying rationale.
Summary of the key strategies to maintain safety in the GI endoscopy unit:
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Each unit should have a designated flow for the safe physical movement of dirty endoscopes and other equipment.
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Procedure rooms vary in size, with more complex procedures requiring greater space for more specialized equipment and, in some cases, additional staff.
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Before starting an endoscopic procedure, the patient, staff, and performing physician should verify the correct patient and procedure to be performed.
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A specific infection prevention plan must be implemented and directed by a qualified person.
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Gloves and an impervious gown should be worn by staff engaged in direct patient care during the procedure.
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The unit should have a terminal cleansing plan that includes methods and chemical agents for cleansing and disinfecting the procedural space at the end of the day.
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For patients undergoing routine endoscopy under moderate sedation, a single nurse is required in the room in addition to the performing physician.
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Complex procedures may require additional staff for efficiency but not necessarily for safety.
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At a minimum, patient monitoring should be performed before the procedure, after administration of sedatives, at regular intervals during the procedure, during initial recovery, and before discharge.
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For cases in which moderate sedation is the target, the individual responsible for patient monitoring may perform brief interruptible tasks.
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For cases in which moderate sedation is the target, there are currently inadequate data to support the routine use of capnography.
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