This statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Nov 2008.
A number of factors including reimbursement have produced a demand for endoscopy to be performed in an office based setting as compared to a hospital or ambulatory center setting. Many gastrointestinal endoscopy procedures can be performed safely in the office setting. To ensure that patients having endoscopy in an office setting have the appropriate level of safety and quality, standards of care need to be set and met. These standards should be similar if not the same as the standards set for an institutional setting.
Clinical practice guidelines are intended to indicate the best available approach to medical conditions as established by a systematic review of available data and expert opinion. The approach suggested may not necessarily be the only acceptable approach given the complexity of the healthcare environment. These guidelines are intended to be flexible, as the surgeon must always choose the approach best suited to the patient and to the variables at the moment of decision. These guidelines are applicable to all physicians who are appropriately credentialed regardless of specialty and address the clinical situation in question.
These guidelines are developed under the auspices of SAGES, the guidelines committee and approved by the Board of Governors. The recommendations of each guideline undergo multidisciplinary review and are considered valid at the time of production based on the data available. New developments in medical research and practice pertinent to each guideline are reviewed, and guidelines will be periodically updated.
Guidelines for Office Endoscopic Services
Only adequately trained and experienced endoscopists should perform endoscopy in an office setting. These endoscopists must meet accepted standards of training and experience. He or she should have staff privileges to perform the same procedure in a institutional setting or qualify for such privileges based on established guidelines such as described by the SAGES Guidelines for Granting of Privileges for Gastrointestinal Endoscopy
Facilities should have been constructed in accordance with local and regional building codes, and those recommended by applicable accreditation organizations, and should be certified as an Ambulatory Surgery Center, or be capable of accreditation. Patient changing areas should be made available away from common areas and a secure location for storing belongings and appropriate bathroom facilities must also 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 assure patient privacy. Mechanisms for the safe evacuation of conscious and sedated patients must exist.
Endoscopy suites should be adequate with regard to size, and should provide the following as a minimum: 1) Reduced illumination from ambient light, 2) Sized for passage of a rolling stretcher through all doorways and passages, 3) Unrestricted access to both sides, and head and foot of the patient, 4) Unimpeded view of monitoring equipment, 5) Sufficient storage for supplies, 6) Appropriate ventilation, 7) Sound and sight privacy boundaries, and 8) Mechanisms for summoning emergency personnel that can be activated without leaving the patient.
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 IV should not undergo endoscopy in the office setting. Patients with an ASA score of III should be further assessed for appropriateness of the office setting. ASA III patients may be acceptable candidates if deemed so by a physician qualified to assess the specific disability and its impact on anesthesia and procedure risks. All women of child-bearing age should be queried about the possibility of being pregnant. Pregnancy testing may be considered in women of child bearing age unless there is a history of total hysterectomy, bilateral tubal ligation or absent menses for one year (menopause).
Patients should receive clear pre procedure instructions. Confirmation of important compliance issues such as NPO status should be documented. Any modifications to standing medication schedules should be provided at the time of scheduling.
Administration of Conscious Sedation
Conscious sedation used as an adjunct to endoscopic procedures must be administered safely. Intravenous access should be established prior to administering 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 administration of any sedatives. Pulse oximetry, cardiac monitoring, automated blood pressure recording, and supplemental oxygen should be routinely employed. 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 Registered Nurse Anesthetists (CRNAs) must have training and experience appropriate to the level of anesthesia administered and function in accordance with their scope of practice. Registered professional nurses (RNs) must have documented competence to administer conscious sedation and to assist in any support or resuscitation measures as required. The individual administering conscious sedation and/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 who is physically present, who is qualified by law, regulation, or hospital appointment to perform and supervise the administration of the sedation/analgesia or minor conduction blockade and who has accepted responsibility for supervision. The physician providing supervision should:
- Assure that an appropriate preanesthetic examination and evaluation is performed proximate to the procedure
- Prescribe the anesthesia;
- Assure that qualified practitioners participate;
- Remain physically present during the entire perioperative period and immediately available for diagnosis, treatment, and management of anesthesia-related complications or emergencies; and
- Assure the provision of indicated post-anesthesia care.
A registered nurse who is certified in Basic Cardiac Life Support (BCLS) should monitor the patient postoperatively and have the capability of administering medications as required for analgesia, nausea/vomiting, or other indications. Monitoring in the recovery area should include pulse oximetry and non-invasive blood pressure measurement. The patient should be assessed periodically for level of consciousness, pain relief, or any untoward complication. A protocol must be present defining the method and means of transfer to a higher level of care institution in the event a complication or unforeseen issue develops with the patient during the procedure or in the post-procedure period.
All office endoscopy patients must be sufficiently recovered from procedures and sedation prior to 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 utilized for patients treated in the hospital setting. If sedation has been used, the patient must be accompanied by a responsible adult at discharge, and be transported home and prohibited from driving or engaging in even low risk activities for a standardized period of time dictated by the sedative agents utilized. Written instructions regarding common complications, directions for returning for emergency evaluation and caution as to continued functional impairment for many hours following conscious sedation are appropriate and should be provided to all patients.
Training of Staff
Staff members should be appropriately trained in resuscitative efforts, and provide documentation of certification in courses such as Basic Cardiac Life Support and Advanced Cardiac Life Support; an ACLS certified provider must accompany all sedated patients throughout their stay. An assistant trained at least in BCLS should be present during all procedures to monitor the patient. During particularly complex or instrument-intensive procedures, where the assistant is likely to be too busy assisting the physician to adequately monitor the patient, a second assistant must be made available to monitor and care for the patient. A registered nurse 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.
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 double-locked 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 both personnel and patient protection from infectious disease must be rigorously observed including body fluid isolation, proper specimen handling as well as proper instrument cleansing and disinfection. Separate sinks should be available for hand washing and for secretion disposal. Endoscopes should be cleaned to a high level of disinfection, as outlined in 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 & 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 below 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.
Each patient should have at minimum a current brief history and physical examination, reviewed by the endoscopist immediately prior to 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 current medications, the justification for the procedure, the description of the endoscopy and pathology found, and the patient’s status on 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 JCAHO and other regulatory agencies, and should conform to HIPAA standards and those others in effect.
There should be an appropriate mechanism of 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 CLIA-certified pathology lab should be maintained for the processing of specimens.
Appropriate records should be kept of accepted indicators that reflect quality levels such as: 1) Cancellation of booked procedures, 2) Unplanned admission to the operating room, 3) Unplanned overnight admission, and 4) Delay in patient discharge.
- Granting of Privileges for Gastrointestinal Endoscopy by Surgeons. Society of American Gastrointestinal Endoscopic Surgeons. 2007.
- American Society of Anesthesiologists (ASA) Physical Status Classification System. Page X, ASA Relative Value Guide 2000
- The Comprehensive Drug Abuse Prevention and Control Act of 1970, October 27, 1970, P. L. 91-513, 84 Stat. 1236, and subsequent amendments.
- Standards for Infection Control and Reprocessing of Flexible Gastrointestinal Endoscopes, Society of Gastroenterology Nurses and Associates, Inc., Practice Committee, 1996.
- Occupational Safety and Health Administration, Occupational Exposure to Bloodborne Pathogens, 29 CFR 1910.1030, December 6, 1991.
- Guidelines for Optimal Office Based Surgery, American College of Surgeons Board of Governors Committee on Ambulatory Surgical Care, Charles F. Frey, MD, FACS, Chairman
- Outpatient endoscopy possibilities for the office. Pike IM. Gastrointestinal Endoscopy Clinics of North America. 12(2):245-58, 2002 Apr.
- Reliable oxygen source with back up tank
- Airway equipment; appropriate sized oral airways, endrotracheal tubes, laryngoscopes, and masks
- Positive pressure ventilation device
- Non-invasive blood pressure apparatus
- Pulse oximeter
- Electrocardiographic monitor
- Temperature monitoring system for procedures lasting more than 30 minutes
- Oxygen analyzer
- Suction Apparatus
- Vasopressors (norepinephrine, isoproterenol, dopamine)
- Calcium Chloride or gluconate
- Sodium bicarbonate
- Magnesium Sulfate
- Potassium Chloride
- Heparin sodium
This statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Nov 2008.
This is a revision of SAGES publication #9 printed Mar 2004, revised Nov 2008.
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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based 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(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. 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 and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.