Driven by advances in minimally invasive diagnostic and therapeutic procedures, the demand for anesthesia and procedural sedation outside the OR has expanded more rapidly than ever. This has placed tremendous strain on anesthesiology departments, both to fulfill anesthesia service needs and to oversee procedural sedation. Nonoperating room anesthesia (NORA) is an extension of OR anesthesiology practice, either personally performed, medically directed, or nonmedically directed. Separate from the extension of anesthesiology services to NORA settings is the procedural sedation performed by nonanesthesiologist providers in many procedural units. Because of the significant variability that may exist in sedation practices (e.g., patient preparation and monitoring, practitioner education and training, oversight of quality and safety in provided care), procedural sedation may place patients, practitioners, and health systems at risk. Whether or not the anesthesiology department fully embraces the role, physician anesthesiologists are responsible for patient safety and regulatory compliance everywhere procedural sedation is performed.
In 2009, The Centers for Medicare & Medicaid Services (CMS) issued the §482.52 Condition of Participation. CMS states that the director of anesthesia services is responsible for all anesthesia services throughout the hospital, including all departments in all campuses and off-site locations where anesthesia services are provided. The directive applies to all moderate and deep procedural sedation services (Table 1) provided by nonanesthesiologist proceduralists (asamonitor.pub/3Lu9m3f; asamonitor.pub/3DCUsG9; asamonitor.pub/3xBk3vl). Moderate sedation is typically provided by a nonanesthesiologist physician proceduralist who is also performing the procedure and a sedation nurse. Deep sedation involves two nonanesthesiologist physician proceduralists – one administers and monitors deep sedation while the other performs the procedure. While the oversight includes both moderate and deep sedation, efforts (and this overview) are generally focused on moderate sedation, as it constitutes almost all the proceduralist-provided sedation services (99.8% vs. 0.2% of total sedation cases, respectively, at the author’s Cleveland Clinic institution) (Anesth Analg 2022;135:198-208). Of note, in developing the Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia, ASA has recognized that sedation is a continuum, and it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to provide a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended.
The first principle in addressing procedural sedation is to set priorities. The first is to ensure patient safety. The second priority is to ensure regulatory compliance for the facility, which requires a comprehensive and consistent set of policies and documentations. The third priority is to facilitate efficient and easy workflows for staff and patients – facilitating practice and eliminating unnecessary documentation burdens whenever possible. Problems occur when the third priority (production pressure) threatens to usurp the first two priorities.
Different facilities and their anesthesiology departments have adopted their own version/structure of meeting CMS procedural oversight mandates. A first step in implementing such oversight is to identify when and where procedural sedation occurs. Until you start looking, you probably don’t know. Throughout the hospital, opioids and/or benzodiazepines are given to patients to treat pain and/or anxiety. That alone is not considered procedural sedation; however, when these medications are used to facilitate a procedure, then procedural sedation safety and regulatory parameters need to be applied to protect the patient. The reason is because the intent of the medication is to suppress an anxious patient to tolerate a painful procedure. Prior consent and additional monitoring throughout are required to protect patients after they lose their intrinsic protective faculties and until they regain their baseline status.
A recently proposed comprehensive oversight program suggested the following structure that could be scaled and modified for use within health systems to meet a hospitals’ size and needs based on the communities they serve (Anesth Analg 2022;135:198-208). A comprehensive oversight program can provide several advantages, as highlighted in Table 2.
Procedural sedation policy
Procedural sedation oversight programs typically start with review of available local policies related to procedural sedation, involving stakeholders, and consolidating those into one comprehensive policy that establishes the standard for procedural sedation services at all sites. Ideally, the policy should aim at meeting local needs, but be based on nationally recognized guidelines and standards and state laws and regulations (J Healthc Risk Manag 2013;33:3-10; asamonitor.pub/3lq2jgi; asamonitor.pub/3Lu9m3f). Complicating the picture, while almost all national professional societies agree with the ASA principles on procedural sedation guidelines, a couple societies have disagreements. For example, the American College of Emergency Physicians does not agree with ASA on preprocedural fasting requirements, and the American Society of Gastrointestinal Endoscopy does not agree with the ASA requirement for capnography monitoring (Ann Emerg Med 2014;63:247-58; asamonitor.pub/3SjkRgf; asamonitor.pub/3mRrUOX; Anesthesiology 2018;128:437-79).
Procedural sedation committee
The next step involves inviting representation from all providers involved in the provision of procedural sedation, including but not limited to medical directors, quality improvement officers, nurse managers, and quality directors to form a multidisciplinary procedural sedation committee led by the director of anesthesia services or their designee. This committee should meet on a regular basis to discuss and update policies, clinical topics, practice and documentation compliance, survey readiness activities, and quality events issues.
The initial “resistance” to the oversight structure generally disappears as proceduralists and sedation nurses recognize the value it provides (Table 2) in the form of education, improving patient safety, improving regulatory compliance and thus successful surveys, improving the procedural sedation team functionality, updating related policies, resolving challenges, and improving operational efficiency.
Procedural sedation locations
There should be a process for credentialing a new procedural sedation service location/unit and site visits to existing and functioning sites to ensure continued safe and compliant practice. It’s important to recognize that the location often includes implicit availability of support in the form of staff, expertise, and resources to manage complications. Consequently, individual proceduralists who may be safe to perform a procedure under sedation in one location may not have that privilege in a location that has less backup.
Procedural sedation privileging and education
The director of anesthesia services has an opportunity to enhance the procedural sedation services by providing local education opportunities for the proceduralists as the need arises. There are also nationally available online courses such as the one provided by ASA (asahq.org/education-and-career/educational-and-cme-offerings/safe-sedation-training—moderate). Setting criteria for training, education, and rescue capabilities, as well as providing physician sedation privileges, are important functions of the director of anesthesia services. Additionally, procedural sedation education and competencies for sedation RNs should be directed under the oversight of the director of anesthesia services in collaboration with nursing education professionals.
Safety, quality, and outcomes
There are countless opportunities where the procedural sedation oversight can enhance patient safety, including:
- Introduction and application of capnography monitoring as recommended by the ASA Standards for Basic Anesthesia Monitoring (asamonitor.pub/3mRrUOX).
- Use of a universal preprocedural checklist, time out before the beginning of the procedure, and sign-out at the end of the procedure.
- “Stop the line” culture where all members of the team can speak up and express concerns regarding the patient, equipment, or the procedure.
- Monitoring safety events and conducting a nonpunitive event review, and identifying lessons learned that should be disseminated to all team members to avoid similar potential future events.
Patients and professional satisfaction
Procedural sedation case cancellation is a common challenge in some procedural areas, mostly due to medical issues such as severe comorbidities, concomitant medications, anticoagulation issues, or lack of proper optimization evident on the day of the procedure. The director of anesthesia services can provide education to identify clinical situations that can be addressed locally through proper consultations for optimization. Moreover, they can provide guidance on identifying high-risk patients who would not be proper candidates for procedural sedation and would require a higher level of care with the anesthesiology team. This has the potential to improve patient and team satisfaction and improve operational efficiencies.
Recovery and discharge criteria should be standardized and communicated, and proper education should be offered, including not allowing patients to drive after receiving procedural sedation.
Anesthesiology oversight will help health systems and hospitals meet the required CMS mandates, which are also followed by accreditation organizations, such as The Joint Commission, and state regulations (asamonitor.pub/2YfqTby). State surveyors can conduct onsite surveys for both CMS and the state as well as a complaint survey. Procedural sedation is a high-risk activity, very commonly evaluated by most surveys. A compendium of relevant material is available from ASA on sedation policies for nonanesthesiologist providers (asamonitor.pub/3qX98bE).
Documentation in procedural sedation is an area for improvement for most programs; use of an electronic medical record when feasible would make standardization, as well as auditing, possible. It can be helpful for the committee to organize informal internal surveys that can identify problems in advance. Additionally, the internal survey process often provides a useful mechanism to support local practices and to build relationships.
Aligning patient safety with a financially viable practice
Procedural sedation has grown substantially. A data set representing one-sixth of the discharges in the U.S. showed that between 2012 and 2015, 500,000 patients had undergone inpatient interventional radiologic procedures with moderate sedation (Radiology 2019;292:702-10). A single center reported an annual 100,000 cases (Anesth Analg 2022;135:198-208). While you and I wish to benefit all those procedural sedation patients with anesthesiologist-led care, it is recognized to be impossible given the size of this service, as highlighted above, and the current workforce shortages. Since many of these procedures will continue to be provided under procedural sedation services, we have an opportunity to make an impact and enhance patient safety by raising the safety standards and also providing proper triaging skills to direct those patients who are not considered proper candidates for procedural sedation to benefit from anesthesiologist-led care. This helps our patients, health systems, hospitals, and communities in general.
Procedural sedation oversight is costly and requires resources and personnel. Moreover, it is a CMS mandate and directly impacts the hospital accreditation status as well as patient safety and the overall cost of care. Therefore, resources needed for this oversight should be provided to the director of anesthesia services to implement this comprehensive oversight. Such funds should be adequate to cover the expenses incurred by the time and effort of the director of anesthesia services and other members of the procedural sedation committee. Health systems, hospitals, and other stakeholders should request and lobby to establish an additional billing item attached to procedural sedation codes that would pay for the anesthesiology oversight efforts. In the meantime, hospitals, not anesthesiology departments, should cover those expenses.
The anesthesiology mandated oversight for procedural sedation is an important patient safety and quality-of-care issue, as highlighted by CMS’ Condition of Participation. It behooves us to embrace this mandate and provide much-needed leadership in our health systems and hospitals. This includes advocacy for the necessary funds and resources to support the director of anesthesia services and to implement and maintain an effective comprehensive procedural sedation oversight program.