Moderate sedation provides for patient comfort and cooperation during many types of office procedures, but its use is not without risks.
The interchangeable terms “moderate sedation” and “conscious sedation” describe a drug-induced depressed level of consciousness. The patient is still able to respond purposefully to verbal commands either with or without tactile stimulation. The patient’s airway reflexes, spontaneous ventilation, and cardiovascular function are typically maintained without interventions—key benefits for the office setting.
Moderate sedation occurs along the continuum of analgesia and anesthesia that ranges from minimal sedation to general anesthesia. CMS and the American Society of Anesthesiologists (ASA) define moderate sedation as analgesia (dulling pain) and not anesthesia (loss of consciousness). (See the ASA Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia.)
Moderate sedation is achieved with oral or injectable medications that depress the patient’s level of consciousness, ease pain, reduce anxiety, and provide amnesia. These benefits, however, trigger additional risks to the patient. Closed malpractice cases reveal instances of patient harm when respiratory or cardiovascular functions were compromised by a deeper level of sedation than anticipated, inadequate monitoring resulted in unrecognized patient distress, or office staff was not trained or prepared to treat airway or medical emergencies.
Strategies to Prevent Patient Injury
The following strategies can help prevent patient injury when providing moderate sedation in the office setting:
Facility Licensure and Accreditation: Comply with federal, state, and local laws and regulations for an office-based facility. Maintain state licensure and obtain accreditation by a national or state accrediting body.
Patient Evaluation: Perform and document a thorough pre-sedation evaluation that includes the patient’s medical, surgical, and anesthesia histories; a focused physical examination that incorporates the airway; a review of consultation and laboratory reports; a notation of allergies; and a review of current medications, including herbal, recreational, and over-the-counter medications.
Patient Selection: Assign the patient a physical status using the ASA Physical Status Classification System. Patients with a physical status greater than “ASA II” should undergo the procedure with moderate sedation in an accredited surgical center rather than the office setting.
Informed Consent: Obtain a signed informed consent. Discuss the benefits and risks of both the procedure and the use of sedation or anesthesia. Retain the signed informed consent form and document the discussion in the record.
Preprocedure Instructions: Provide the patient with clearly written preprocedure instructions, including the need for NPO status.
Preprocedure Examination: Evaluate and document the patient’s medical condition, including current NPO status immediately prior to initiating treatment. Examine the patient’s vital signs and airway, and auscultate the heart and lungs.
Assistive Staff: Have an adequate number of assistive staff involved in the patient’s care. Generally, a minimum of two trained staff members is required—one to assist the clinician and one to monitor and support the patient. The staff member monitoring the patient must be competent to recognize apnea or airway obstruction. An individual competent to provide airway management (bag/mask ventilation with oxygen) must be immediately available. Follow any state requirements on the training, certification, and use of assistants in procedures involving patient sedation.
Team Brief: Conduct a team brief before each procedure that includes the patient and staff to ensure all team members understand the treatment and sedation goals, roles and responsibilities, plan of care, and resources needed.
Universal Protocol: Follow the universal protocol of preprocedure verification, site marking, and a time-out immediately prior to the procedure to prevent wrong-patient, wrong-procedure, wrong-side or -site, or wrong-position events.
Patient Monitoring: Monitor ventilatory function and oxygenation continuously by observation, auscultation, capnography, and oxygen saturation. Monitor blood pressure, heart rate, and level of consciousness at a minimum of every five minutes. Keep all monitor alarms on and audible. Maintain contemporaneous documentation of vital signs.
Postprocedure Care: Provide a minimum of 30 minutes of postprocedure monitoring to ensure that vital signs, level of consciousness, and respiratory status have met criteria for release. Address complications such as dizziness, nausea, vomiting, or respiratory depression. Provide written instructions for home care and follow-up.
Staff Certifications: Maintain Advanced Cardiac Life Support certification for all members of the care team who supervise, administer, or monitor moderate sedation. Maintain Basic Life Support certification for other members of the care team. Document the training and keep current certificates in employee files.
Emergency Preparations: Ensure that emergency equipment, medications, and supplies are readily available, and develop written protocols for handling various types of emergencies. If services are provided to pediatric patients, include pediatric equipment, medications, supplies, and protocols. Make sure that staff members, including new or temporary staff or students, are properly trained on the protocols and the location and use of equipment. Review and follow all applicable state laws on emergency preparedness.
Emergency Drills: Conduct periodic emergency drills and simulation training to aid in efficient and effective response to emergencies. Make sure that staff members can identify the signs of an urgent or emergent situation.
Emergency Tasks: Assign tasks related to emergencies to individual staff members. Assignments include retrieving emergency supplies, checking patient vital signs, and calling 911. Establish a backup plan that addresses staff absences.
Scope of Practice: Verify the level of training required for staff positions and the role of any student rotating through the practice. (For example, is the student’s role only to observe or are specific patient care tasks permitted?) Do not delegate tasks to students or staff members that are outside their level of education, training, and legal scope of practice.
Equipment Maintenance: Follow and document an equipment maintenance schedule according to manufacturers’ recommendations to ensure that all monitoring and emergency equipment is working properly.
Medication Inventory: Inventory emergency medications regularly and replace expired medications.
Adverse Event Reporting: Follow all state laws, licensing board requirements, and the malpractice insurer’s guidelines on reporting and disclosing adverse events.
Maintain Competence: Keep abreast of the latest research and drug modalities for moderate sedation. Be aware of the pharmacology of the drugs being used, including the use and availability of reversal agents.
Get Additional Help
For guidance and assistance in addressing any patient safety or risk management concerns, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.