In 2009, the Centers for Medicare and Medicaid 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 CMS1 without evidence demonstrating that safety or clinical outcomes in endoscopy are thereby improved. Although the 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)2, 3, 4, 5 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. Where data is 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. Over the past 2 years, surveyors have called into question accepted practices at many accredited endoscopy units seeking re-accreditation. Many of these issues relate to the Ambulatory Surgical Center (ASC) Conditions for Coverage set forth by CMS and the lack of distinction between the sterile operating room and the endoscopy setting. The following is a summary of issues that have been faced by endoscopy units throughout the country along with ASGE’s position and accompanying rationale. Issue: Structural requirements for 40-inch doors and room sizes >400 square feet required of sterile operating rooms. Position: Standard 36-inch doors, if they accommodate patient transport mechanisms, and room sizes 180 square feet are adequate and safe for endoscopy units because they do not use the same large equipment or number of staff as in the operating room.6 Issue: Requirement for a written policy on traffic patterns in the endoscopy unit. Position: The unit should define low-risk exposure and high-risk exposure areas and activities within the endoscopy unit, and describe the attire and personal protective equipment that should be worn in each area. Endoscopy staff can move freely throughout the unit provided that there is appropriate use and changing of personal protective equipment. Issue: Requirement for endoscopy personnel to don full sterile operating room personal protective equipment including new scrubs, hair covers and booties. Position: It is recommended that staff directly engaged in GI endoscopy or in processes where splash or contamination could occur should wear gloves, face/eye shields, and an impervious gown. Units should develop policies that are consistent with OSHA and state-mandated recommendations for wearing face/eye shields or masks.7 Scrubs or other attire may be worn from home because endoscopy is not a sterile procedure. Likewise, there is no need for hair covers or booties. Staff must remove and appropriately discard used PPE before leaving the procedure area. Issue: Supervision of moderate sedation. Position: Moderate sedation may be administered safely under the supervision of a non-anesthesia physician who is credentialed and privileged to do so. Issue: Role of capnography. Position: There is inadequate data to support the routine use of capnography where moderate sedation is the target. Issue: Requirement that 2 nurses (one monitoring, one circulating) are present when moderate sedation is performed. Position: When moderate sedation is the target, a nurse should monitor the patient and can perform interruptible tasks. If more technical assistance is required, a second assistant (nurse, licensed practical nurse, or unlicensed assistive personnel) should be available to join the care team. Issues: Staffing requirements when sedation and monitoring is provided by anesthesia personnel. Position: When sedation and monitoring is provided by anesthesia personnel, a single additional staff person (nurse, licensed practical nurse, or unlicensed assistive personnel) is sufficient to assist with technical aspects of the procedure. Issue: Technical capabilities of technicians. Position: Unlicensed technicians, who have received initial orientation and ongoing training, and are deemed competent by their unit, can assist with and participate in tissue acquisition during the endoscopic procedure, including but not limited to the opening and closing of forceps, snares, and other accessories.
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Jul 31, 2024
Jisun Lee + 2
Open Access