Introduction
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.
Privileges
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 an institutional setting or qualify for such privileges based on established guidelines such as described by the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Guidelines for Granting of Privileges for Gastrointestinal Endoscopy.
Physical Environment
Facilities should have been constructed in accordance with local and regional building codes, and those recommended by applicable accreditations 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.
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 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).
Patient Safety
Patients should receive clear pre procedure 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.
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
- 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
See the original guideline document for full details.
Equipment and Medication Requirements
See the original guideline document for full details.
Documentation
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 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and other regulatory agencies, and should conform to Health Insurance Portability and Accountability Act (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 Clinical Laboratory Improvement Act (CLIA)-certified pathology lab should be maintained for the processing of specimens.
Quality Improvement
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.
