Hospital Accreditation

Moderate sedation, sometimes referred to as conscious sedation or procedural sedation is a drug-induced depression of consciousness during which patients can still purposefully respond to verbal commands. Interventions are not required to maintain airway and cardiovascular function is maintained.

Moderate sedation may be performed throughout the organization by non-anesthesia providers in accordance with law and regulation and organizational policy. Common places include emergency departments, radiology suites, intensive care units, endoscopy suites, pain clinics, and catheterization/electrophysiology suites. You can be assured that all places and clinics that administer moderate sedation will be surveyed during an accreditation survey. CMS and other accrediting organizations have regulations around the safe performance of moderate sedation. Let’s take a quick look at some of them:

Providers have been granted privileges to perform sedation
The organization needs to grant the privilege to perform moderate sedation to providers. Some categories of providers may include the privilege to administer sedation as a core privilege; for others, it may require a separate request. Either way, there must be demonstrated competency and training to perform sedation, and periodic reappraisal. CMS 482.22(a)(1) requires that the qualifications and demonstrated competencies to perform each task within the scope of privileges are evaluated. Additionally, CMS 482.52 requires that anesthesia services develop policies and procedures that address the minimum qualifications and supervision requirements for each category of practitioner who is permitted to provide analgesia services, particularly moderate sedation. Monitoring practice through professional practice evaluation will ensure that quality safe care is delivered.

Staff complete initial and ongoing training for competency for moderate sedation (482.23(b)(5) and 482.23(c)(3))
Staff who administer moderate sedation and/or monitor patients must have documented competencies. Organizations can define the type of training requirements; typically, this includes ACLS, a didactic moderate sedation review, or online training. This must be completed during orientation and at periodic intervals, as defined by the organization.

Pre-procedure Requirements

• Informed consent – medical staff policies should define which treatments and procedures require written informed consent. Additionally, Federal and State law may guide informed consent. If required, it must be properly completed and in the record prior to the procedure.
• Education – education must be provided and documented regarding the sedation and procedure to be performed.
• Pre-sedation evaluation – CMS does not consider moderate sedation to be anesthesia, however, that does not mean that an evaluation is not required. CMS 482.52(b)(1) requires that patients receiving moderate sedation be monitored and evaluated before, during, and after the procedure by trained practitioners. Hospitals should define in policy the required evaluations prior to administration of moderate sedation. All accreditors do require a focused pre-sedation evaluation/assessment that includes at least an airway and cardiovascular assessment. For medically unstable patients, the American Society of Anesthesiologists (ASA) recommends consulting an anesthesiology provider. Additionally, the Joint Commission requires a re-evaluation immediately prior to administering moderate sedation.

Intra-procedure Requirements (482.52(b)

• A designated individual other than the practitioner must be available throughout the procedure for patient monitoring. This individual should not be a member of the procedural team, but may assist with minor, interruptible tasks once the sedation is established.
• The organization should define in policy the requirements for monitoring the patient during moderate sedation, but minimally, the patient’s vital signs, oxygen levels, and level of consciousness are monitored. This should occur prior to and immediately after the administration of the sedative/analgesic and at least every five minutes during the procedure. ASA also recommends the use of capnography whenever possible. All equipment alarms should be functioning.
• Hospitals must ensure that procedures are in place to rescue patients whose level of sedation becomes deeper than initially intended, for example, patients who inadvertently enter a state of Deep sedation/analgesia when Moderate sedation was intended. Age-specific advanced airway equipment, suction, defibrillator, and pharmacologic antagonists should be immediately available.

Post-Procedure Requirements

• The patient’s physiological status must be monitored during recovery. This can be at a timeframe established by hospital policy. Minimally, the monitoring should include mental status, vital signs and oxygenation, and pain levels. Monitoring should continue until the patient returns to baseline status.
• A provider must discharge the patient from the recovery area or the hospital or the patient may be discharged by criteria that has been approved by leadership.

Implementing a Safe Discharge
CMS 482.43(c)(5) requires that patients and/or family members be counseled to prepare them for post-hospital care, including what to do when concerns or problems arise. Ensure that the discharge instructions are included in the medical record and contain education regarding the procedure and the sedation medication. Examples of sedation education include not driving, operating machinery, or making life decisions for 24 hours after sedation. For pediatric patients, assuring adult supervision is available until the patient is fully recovered should be included. Patients receiving sedation should be discharged with a responsible adult to provide transportation.

QAPI
Outcomes of sedation must be monitored, reported, trended, and analyzed to look for patterns of adverse events. CMS performance improvement standards related to moderate sedation include:

Accrediting organizations will expect an organization to have data around any adverse reactions or unanticipated outcomes related to moderate sedation. Tracking the use of reversal agents administered after sedation is one helpful way to identify potential adverse reactions along with internal reporting mechanisms. Information on sedation events should be reported up through committee to the governing body.

Resources:
American Society of Anesthesiologists Task Force, (2018). Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018. Anesthesiology,128, 437-479. doi: https://doi.org/10.1097/ALN.0000000000002043

Centers for Medicare and Medicaid Services, (2020). State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals. Retrieved from https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf