Surg Endosc (2009) 23:1125–1129 DOI 10.1007/s00464-009-0410-x

GUIDELINES

Society of American Gastrointestinal Endoscopic Surgeons (SAGES) guidelines for office endoscopic services Steven Heneghan Æ Jonathan Myers Æ Robert Fanelli Æ William Richardson

Received: 18 December 2008 / Accepted: 11 February 2009 / Published online: 20 March 2009 Ó Springer Science+Business Media, LLC 2009

Preamble A number of factors, including reimbursement, have produced a demand for endoscopy to be performed in an office-based setting compared with a hospital or ambulatory center setting. Many gastrointestinal endoscopy procedures can be performed safely in the office setting. To ensure that patients undergoing an endoscopy in an office setting have the appropriate level of safety and quality, standards of care must be set and met. These standards should be similar to, if not the same as, the standards set for an institutional setting.

Disclaimer Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations are based

S. Heneghan (&)
J. Myers Department of Surgery, Rush University Medical Center, Chicago, USA e-mail: [email protected] S. Heneghan Bassett Healthcare, Cooperstown, NY, USA R. Fanelli Surgical Specialists of Western New England, PC, Pittsfield, USA W. Richardson Department of Surgery, Ochsner Clinic Foundation, New Orleans, USA

on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem or problems without regard to specialty training or interests. They are intended to indicate the preferable but not necessarily the only acceptable approaches. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision. Guidelines are developed under the auspices of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) and its various committees and approved by the Board of Governors. Each clinical practice guideline is systematically researched, reviewed, and revised by the guidelines committee, then reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of their formulation based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments into medical research knowledge and practice.

Privileges Only adequately trained and experienced endoscopists should perform endoscopy in an office setting. These endoscopists must meet accepted standards of training and experience. They should have staff privileges to perform the same procedure in a institutional setting or qualify for such privileges based on established guidelines such as those described by the SAGES Guidelines for Granting of Privileges for Gastrointestinal Endoscopy.

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Physical environment

Patient safety

The construction of facilities should be in accordance with local and regional building codes and those recommended by applicable accreditation organizations. Each facility should be certified as an ambulatory surgery center or capable of accreditation. Patient-changing areas should be made available away from common areas and at a secure location for storing belongings. Appropriate bathroom facilities also must be available. The facility should comply with the standards of the Americans With Disabilities Act. A waiting room should be available for family members. Appropriate consultation and treatment rooms must be constructed to ensure patient privacy. Mechanisms must be in place for the safe evacuation of conscious and sedated patients. Endoscopy suites should be adequate in terms of size, with provision of the following as a minimum:

Patients should receive clear preprocedure instructions. Confirmation of important compliance issues such as nothing by mouth (NPO) status should be documented. Any modifications to standing medication schedules should be provided at the time of scheduling.

1. 2. 3. 4. 5. 6. 7. 8.

Reduced illumination from ambient light Passage sized for moving a rolling stretcher through all doorways and passages Unrestricted access to both sides and to the head and foot of the patient Unimpeded view of monitoring equipment Sufficient storage for supplies Appropriate ventilation Sound and sight privacy boundaries Mechanisms for summoning emergency personnel that can be activated without leaving the patient.

Patient selection Prudent selection of both procedures and patients appropriate for office endoscopy is critical. Procedures having intrinsic risk or requiring technology not available in the endoscopist’s office should be performed in an institutional setting. All patients scheduled for endoscopic procedures should be assigned an anesthesia risk score using the American Society of Anesthesiologists (ASA) score. Patients with an ASA score of 4 should not undergo endoscopy in the office setting. Patients with an ASA score of 3 should be assessed further for appropriateness of the office setting. An ASA 3 patient may be an acceptable candidate if deemed so by a physician qualified to assess the specific disability and its impact on anesthesia and procedure risks. All women of childbearing age should be queried about the possibility of being pregnant. Pregnancy testing may be considered for women of childbearing age unless there is a history of total hysterectomy, bilateral tubal ligation, or no menses for 1 year (menopause).

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Administration of conscious sedation Conscious sedation used as an adjunct to endoscopic procedures must be administered safely. Intravenous access should be established before administration of sedatives and maintained until the patient has recovered sufficiently to permit safe discharge. There must be appropriate monitoring and expertise in managing potential associated complications such as respiratory depression and cardiac arrest. Baseline pulse, respiratory rate, oxygen saturation, and blood pressure should be recorded before any sedatives are administered. Pulse oximetry, cardiac monitoring, automated blood pressure recording, and supplemental oxygen should be used routinely. Emergency medications and equipment used for cardiopulmonary resuscitation including adequate oral suction, a defibrillator, ambu bag, laryngoscope, and emergency airway tray must be readily available and checked on a daily basis. Anesthesia should be administered only by a licensed, qualified, and competent practitioner. Registered professional nurses (RNs) who administer analgesic or sedative drugs as part of a medical procedure (including but not limited to certified RN anesthetists) must have training and experience appropriate to the level of anesthesia administered and must function in accordance with their scope of practice. An RN must have documented competence to administer conscious sedation and to assist in any support or resuscitation measures as required. The individual administering conscious sedation or monitoring the patient cannot be involved in uninterruptible duties. Supervision of the sedation/analgesia component of the medical procedure should be provided by a physician physically present and qualified by law, regulation, or hospital appointment to perform and supervise the administration of the sedation/analgesia or minor conduction blockade who has accepted responsibility for supervision. The physician providing supervision should: 1. 2. 3. 4.

Ensure that an appropriate preanesthetic examination and evaluation is performed proximate to the procedure; Prescribe the anesthesia; Ensure that qualified practitioners participate; Remain physically present during the entire perioperative period and be immediately available for diagnosis,

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5.

treatment, and management of anesthesia-related complications or emergencies; Ensure the provision of indicated postanesthesia care.

An RN certified in basic cardiac life support should monitor the patient postoperatively and should have the capability of administering medications as required for analgesia, nausea and vomiting, and other indications. Monitoring in the recovery area should include pulse oximetry and noninvasive blood pressure measurement. The patient should be assessed periodically for level of consciousness, pain relief, and any untoward complications. A protocol must be present defining the method and means of transfer to an institution with a higher level of care in the event that a complication or unforeseen issue develops with the patient during the procedure or in the postprocedure period. All office endoscopy patients must be sufficiently recovered from procedures and sedation before discharge and should meet uniform standard discharge criteria. Patients who receive sedation must have their vital signs, respiratory status, and mentation monitored in a manner consistent with that used for patients treated in the hospital setting. If sedation has been used, the patient must be accompanied by a responsible adult at discharge, transported home, and prohibited from driving or engaging in even low-risk activities for a standardized period dictated by the sedative agents used. Written instructions regarding common complications, directions for returning to receive an emergency evaluation, and caution as to continued functional impairment for many hours after conscious sedation are appropriate and should be provided to all patients.

Training of staff Staff members should be appropriately trained in resuscitative efforts. They should provide documentation of certification in courses such as basic cardiac life support and advanced cardiac life support (ACLS). An ACLScertified provider must accompany all sedated patients throughout their stay. An assistant trained at least in basic cardiac life support should be present during all procedures to monitor the patient. During particularly complex or instrument-intensive procedures, in which the assistant is likely to be too busy assisting the physician to monitor the patient adequately, a second assistant must be made available to monitor and care for the patient. An RN should be available in the recovery area. A formal transport agreement with an acute care facility capable of managing endoscopic complications must be in place and easily executed when necessary.

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Equipment and medication requirements Medications must be stored in a secure location, and appropriate compliance with the Controlled Substances Act must be documented. Sedatives should be stored in doublelocked cabinets, and a log of medication expiration dates should be maintained. Appropriate reversal agents and experience with their use should be available. Patient care should not be compromised by a lack of equipment required to perform the proposed procedure in the office setting. A qualified professional should do periodic preventive maintenance and testing of equipment, and a service log should be maintained for all equipment. Guard rails, wide procedure tables, and other appropriate means should be used as necessary to prevent falls and mechanical injury during and after endoscopic examinations. Standard protocols for protection of both personnel and patient from infectious disease must be rigorously observed including body fluid isolation, proper specimen handling, and proper instrument cleansing and disinfection. Separate sinks should be available for hand washing and secretion disposal. Endoscopes should be cleaned to a high level of disinfection according to the Standards for Infection Control and Reprocessing of Flexible Gastrointestinal Endoscopes as issued by the Society of Gastroenterology Nurses and Associates. Reprocessing should be done in a well-ventilated room separate from patient care areas, and physical separation of clean and contaminated equipment is vital to avoid cross-contamination. Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens regulations must be adhered to as required locally, regionally, and nationally. Emergency resuscitative equipment and a reliable source of oxygen as outlined in the Appendix must be current and readily available. Monitoring equipment should include a continuous suction device, pulse oximeter, and noninvasive blood pressure cuff. Electrocardiographic monitoring should be available for patients with a history of cardiac disease. Age-appropriate-sized monitors and resuscitative equipment should be available for pediatric patients.

Documentation Each patient should have at minimum a current brief history and physical examination, reviewed by the endoscopist immediately before the procedure. Serious cardiopulmonary or other disease should be excluded by appropriate clinical and, if necessary, laboratory evaluation. The patient chart should contain the clinical examination and evaluation, a list of medication allergies and

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current medications, the justification for the procedure, the description of the endoscopy and pathology found, and the patient’s status at discharge. Informed consent for the procedure should be documented in the chart consistent with local professional standards and applicable state law. Records should be maintained so that complications and problems can be identified and compliance with recommendations for clinical and endoscopic care ensured. Records and clinical documents should adhere to the same standards required for institutions by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO0 and other regulatory agencies, and should conform to the Health Insurance Portability and Accountability Act (HIPAA) standards and others in effect. An appropriate mechanism should be in place for relating findings and the results of pathologic studies to patients and referring physicians as well as for the tracking of specimens. Indications, findings, treatment results, and complications should be kept in a database, and periodic peer review of this data should be performed. Written policy and procedure manuals should be maintained and kept up to date, and a written agreement with a Clinical Laboratories Improvement Act (CLIA)-certified pathology lab should be maintained for the processing of specimens.

Quality improvement Appropriate records of accepted indicators that reflect quality levels should be kept such as cancellation of booked procedures, unplanned admission to the operating room, unplanned overnight admission, and delay in patient discharge. Appendix I. Reliable oxygen source with a backup tank II. Airway equipment; appropriate-sized oral airways, endrotracheal tubes, laryngoscopes, and masks III. Positive-pressure ventilation device IV. Equipment a. b. c. d. e. f.

Defibrillator Noninvasive blood pressure apparatus Pulse oximeter Capnography Electrocardiographic monitor Temperature-monitoring system for procedures lasting more than 30 min g. Oxygen analyzer

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V. Suction apparatus VI. Drugs a. b. c. d. e. f. g. h. i. j. k. l. m. n. o. p. q. r. s. t. u. v. w. x. y. z.

Epinephrine Atropine Antihistamines Hydrocortisone Ephedrine Vasopressors (norepinephrine, isoproterenol, dopamine) Calcium chloride or gluconate Glucose Naloxone Romazicon Antiemetics Sodium bicarbonate Lidocaine Adenosine Magnesium sulfate Digoxin Furosemide Potassium chloride Heparin sodium Aspirin Amiodarone Verapamil Procainamide Nitroglycerin Esmolol Labetolol

This document was prepared and revised by the SAGES Guidelines Committee: Steven Heneghan, MD Jonathan Myers, MD Robert Fanelli, MD, Chair David Earle, MD Jeffrey Hazey, MD John Kilkenny III, MD Jay Redan, MD Raymond Price, MD Keith Apelgren, MD Ronald Clements, MD Timothy Farrell, MD Erika Fellinger, MD Stephen Haggerty, MD James Korndorffer, MD Thom Lobe, MD Sumeet Mittal, MD David Overby, MD Patrick Reardon, MD William Reed, MD David Renton, MD

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E. Matthew Ritter, MD Alan Saber, MD J. Salameh, MD Dimitrios Stefanidis, MD William Richardson, MD, Co-Chair This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), November 2008. Requests for reprints should be sent to: Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 11300 West Olympic Boulevard, Suite 600 Los Angeles, CA 90064, USA Phone: (310) 437-0544 Fax: (310) 437 0585 email: [email protected] www.sages.org This is a revision of a SAGES publication printed in March 2004.

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References Granting of Privileges for Gastrointestinal Endoscopy by Surgeons (2007) Society of American Gastrointestinal Endoscopic Surgeons American Society of Anesthesiologists (ASA) (2000) Physical Status Classification System. Page X, ASA Relative Value Guide The Comprehensive Drug Abuse Prevention and Control Act of 1970 (1970) P. L. 91-513, 84 Stat. 1236, and subsequent amendments Standards for Infection Control and Reprocessing of Flexible Gastrointestinal Endoscopes (1996) Society of Gastroenterology Nurses and Associates, Inc., Practice Committee Occupational Safety and Health Administration (1991) Occupational Exposure to Bloodborne Pathogens, 29 CFR 1910.1030, 6 December Guidelines for Optimal Office-Based Surgery, American College of Surgeons Board of Governors Committee on Ambulatory Surgical Care, Charles F. Frey, MD, FACS, Chairman Pike IM (2002) Outpatient endoscopy possibilities for the office. Gastrointest Endosc Clin North Am 12:245–258

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