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Special Articles: Special Article

A Blueprint for Success: Implementation of the Center for Medicare and Medicaid Services Mandated Anesthesiology Oversight for Procedural Sedation in a Large Health System

Abdelmalak, Basem B. MD, FASA, SAMBA-F*†‡; Adhami, Talal MD, HCMBA, AGAF, FAASLD§; Simmons, Wendy MSN, RN; Menendez, Patricia MS, BSN, RN, HACP; Haggerty, Elizabeth MLRHR, MBA#; Troianos, Christopher A. MD, FASE, FASA**

Author Information
doi: 10.1213/ANE.0000000000006052

Abstract

The need for procedural sedation (PS) has grown substantially during the past 2 decades. While numerical estimates of patients undergoing PS in the United States are not widely available, conclusions can be drawn from sample population analyses. For example, data from 853 hospitals representing one-sixth of the discharges in the United States showed that between 2012 and 2015, 500,000 patients had undergone an inpatient interventional radiology (IR) procedure with moderate sedation.1 Extrapolation of these data to all inpatients and outpatients in all PS areas yields a sizable patient population annually in the United States and around the world.

In 2009, the Center for Medicare and Medicaid Services (CMS) issued the §482.52 Condition of Participation (CoP) that the director of anesthesia services (DAS)2 is responsible for all anesthesia administered in the hospital.3 Therefore, this mandate extends to oversight of moderate and deep PS provided by nonanesthesiologist proceduralists.3 Furthermore, CMS issued interpretive guidelines for this CoP to provide additional details regarding its expectations from this mandate.4

Although this mandate was issued several years ago, many anesthesiology departments remain uncertain as to how best to implement this expected oversight. Who needs to be involved? What resources are needed? And how to leverage this oversight to improve quality of care and patient safety?

In smaller hospitals, it is generally feasible for the chair of the anesthesiology department to provide this oversight for PS. However, in large multihospital health systems for which this might not be feasible, an example of another arrangement is that the chair may elect to establish a center for PS and appoint a qualified anesthesiologist to lead this effort. This leader of the PS oversight, whether it is the chair or his/her designee, will assess the needs and constitute an executive PS committee that would offer support, guidance, and monitoring for meeting the requirements of this CoP as further described below.

This article reviews the CMS CoP interpretive guidelines and other regulations as they relate to PS, outlines the components and benefits of anesthesiology oversight, describes the tools, and offers a structure to implement these guidelines. In addition, we discuss implementation-related challenges. This initiative continues to evolve and expand as needs change and experience develops.

MODERATE VERSUS DEEP PS

Moderate sedation is typically provided by a physician (nonanesthesiologist) proceduralist who is also performing the procedure and a sedation registered nurse (RN). This RN has received sedation education and is specifically trained in monitoring and related competencies of patients undergoing procedures with moderate sedation, under the guidance of the physician proceduralist who is qualified by education, licensure, and certification.

Deep sedation involves 2 physicians (nonanesthesiologist proceduralists): one dedicated solely to administering the deep sedation and monitoring the patient, and the other to perform the procedure.

While moderate sedation (versus deep sedation) is typically provided by nonanesthesiologists (99.8% vs 0.2% of total PS cases, respectively, at the authors’ institution) and thus the major focus of the oversight effort, PS oversight encompasses both moderate and deep sedation practices at any given hospital.

It is prudent to consider the administration of any dose of any medication that is classified by the pharmacy as an anesthetic (eg, propofol, ketamine, and etomidate) as deep sedation regardless of the intended level of sedation. This designation is due to a narrow safety profile in titrating these anesthetic medications for sedation. For example, patients can become unresponsive and apneic without previous warning, even with low doses of propofol when used for sedation. Moreover, these medications lack a specific reversal agent, unlike opioids and benzodiazepines typically used for moderate sedation. Table 1 summarizes the difference between moderate and deep sedation.

Table 1. - Differences Between Moderate and Deep Procedural Sedationa
Comparison item Moderate sedation Deep sedation
Responsiveness Purposeful response to verbal or tactile stimuli Purposeful response to painful stimulus
Airway No airway support intervention is required Airway support intervention may be required
Spontaneous ventilation Adequate May not be adequate
Hemodynamics Remains stable Remains stable
Privilege requirements Physicians should be trained and judged to be able to provide the service safely Physicians should be trained and judged to be able to provide the service safely
Biannual ACLS and online sedation course certification required Biannual ACLS and online sedation course certification required
Biannual airway training course encouraged Biannual airway training course required
Personnel Nonanesthesiologist physician proceduralist and a sedation RN Two nonanesthesiologist physician proceduralists
Prevalence The most commonly used sedation level by nonanesthesiologist proceduralists Rarely used sedation level by nonanesthesiologist proceduralists
Most commonly used medications Benzodiazepines (eg, midazolam) and narcotics (eg, fentanyl) Same as medications for moderate sedation, and/or low-dose anesthetics (eg, propofol or ketamine)
No anesthetics (eg, propofol, ketamine, or etomidate) allowed
Abbreviations: ACLS, advanced cardiovascular life support; RN, registered nurse.
aPlease see text and Table 4 for more details.

It is not necessary to specify the type or dose of any moderate sedation medication in a given sedation policy. Nevertheless, using medications with a fast onset and a short half-life (eg, fentanyl) instead of the longer-acting medications (eg, meperidine and morphine) is recommended to avoid stacking of medication doses, and for faster recovery and discharge.

PS OVERSIGHT PROGRAM DEVELOPMENT

Programmatic development begins with surveying physician proceduralists to collect information and build a database, which includes the following: who (physicians), what (procedures), where (locations), level of sedation used, and case volumes. Data collection identifies the privileging status of all physicians, and whether they have needs that could be provided by the anesthesiology department through an oversight arrangement. A town hall meeting with leaders and nurse managers from procedural areas across the health system is helpful to explore the current state of affairs and assess the needs and challenges of each location. This background information is instrumental in establishing the oversight process and building rapport with each individual service. The next step is to identify and review available local policies related to PS and consolidate those into one comprehensive policy that establishes the standard for a PS service at all sites. Structuring such a comprehensive policy across multiple service lines can be a labor-intensive process and should involve stakeholders from all involved disciplines.5 Ideally, the policy should be tailored to meet the local needs of each individual hospital within a health system,5 but grounded in nationally recognized guidelines and standards4 that are in line with state laws and regulations.

STRUCTURE

After initial exploration of the scope of the task and need assessment, different components of PS oversight should be identified as outlined below. These components provide the framework for the oversight structure and procedures that would work across a large multihospital system. The structure should be scaled and modified to meet the size and needs of each individual facility.

PS COMMITTEE

The next step involves the formation of a PS committee with representation from all stakeholders and constituents within every PS area (medical directors, quality improvement officers, nursing director and managers, and quality directors). This committee should meet on a regular basis to discuss and review new or updated policies, clinical topics, compliance and quality reports, survey readiness topics, and quality events discussions. Members should constantly be reminded of the deliverable expectations (Supplemental Digital Content 1, Table 1, https://links.lww.com/AA/D931).

In addition, a multidisciplinary subgroup of the PS committee (executive committee) should be established to set goals for the enterprise, monitor compliance and quality events, and be nimble in response to urgent matters. The suggested roles of such a committee and its individual members are listed in Table 2.

Table 2. - Members of the Procedural Sedation Executive Committee and Their Roles
Member Specific roles
Chair, anesthesiologist Director of anesthesia services/designee
Oversees and approves PS privileges
Leads the PS committee bimonthly meetings
Leads the PS executive committee biweekly meetings
PS quality improvement officer
Leads site visits
Oversees quality monitoring, reporting, and follow-up
Develops and updates online PS education module and material
Develops and presents nursing sedation education didactic
Addresses day-to-day PS issues as they arise at different locations
Reports to the director of anesthesia and senior enterprise leadership
Co-chair proceduralist Represent the proceduralists
Leads above efforts in the absence of the committee’s chair
Participate in all PS committee and PS executive committee activities, especially as they relate to proceduralists education and other topics
Accreditation assistant director Leads survey readiness activities and reports
Participates in all PS committee and executive committee activities
Liaison to the enterprise accreditation team
Administrator/program manager Provides administrative and backbone support to the PS activities
Organizes meetings and site visits
Keeps track of projects and filing of documents
Maintains the procedural sedation web site
Quality director Monitoring of quality reports
Participates in all PS committee and executive committee activities
Liaison to the enterprise quality institute
Patient safety specialist Monitoring of patient safety initiatives and goals
Participates in all PS committee and executive committee activities
Liaison to the enterprise patient safety team
Nurse manager of one of the PS areas Represents front line sedation RNs
Participates in all PS committee and executive committee activities
Advisor to other PS nurse managers and sedation RNs
Ambulatory surgical nursing director Represent ASCs sedation RNs and managers
Participates in all PS committee and executive committee activities
Liaison to the ASC and enterprise nursing leadership
Surgical nursing senior director Represents all PS nursing enterprisewide
Liaison to the enterprise nursing leadership
Participates in all PS committee and executive committee activities
Office of professional staff administrative coordinator Monitors and addresses all physician privileging issues
Participates in all PS committee and executive committee activities
Liaison to the office of professional staff
Life safety and facilities compliance manager Addresses all facility, fire, and safety regulatory matters
Liaison to their respective department
Administrative assistant Assist the committee co-chairs and administrator
Filing of PS committee and executive committee activities, and documents
Participates in all PS committee and executive committee activities
Procedural sedation executive committee general roles for all members Discussion and preparation of projects and policies that need to be presented to the enterprise PS committee for feedback and buy-in
Be available to provide support and guidance to the teams in different sedation areas
Keep up with evolving national trends and guidelines, state laws, and regulations
Credentialing of new PS locations, and monitoring (including repeated site visits) of existing ones
Advancement and standardization of safe PS practices
PS education and training
Abbreviations: ASC, ambulatory surgery center; PS, procedural sedation; RN, registered nurse.

Table 3. - Procedural Sedation Practice Locations and Numbers of Moderate and Deep Sedation Cases at the Authors’ Institution in 2019
Location Number of procedures under moderate sedation Number of procedures under deep sedation Procedure rooms Prebeds/postbeds
GI endoscopy units 44,963 0 21 64
ASCs 17,674 0 10 79
Cardiac catheterization/echo 10,381 0 10 19
Radiology—interventional 5177 0 9 24
Bronchoscopy suite 4106 0 5 10
Pain medicine 2473 0 6 9
Electrophysiology laboratory 1949 27 8 13
Nerve block room 1607 0 4 6
Radiology—noninterventional 1184 0 4 12
Vascular surgery 401 0 4 0
ICUs 385 25 0 0
EDs 136 105 0 0
Urology 52 0 16 5
Oral surgery 41 0 1 2
Dermatology/plastics 17 0 4 8
Totals (%) 90,546 (99.8) 157 (0.2) 102 251
Areas without procedure rooms or prebeds/postbeds are ICUs or EDs, where procedures can be performed in all available rooms. Procedures performed at the ASCs are mostly GI and pain medicine procedures.
Abbreviations: ASC: ambulatory surgery center; ED, emergency department; GI, gastrointestinal; ICU, intensive care unit.

A new oversight program may discover a reluctance to adopt a systemwide approach by some proceduralists, but this hesitancy should wane as proceduralists and sedation RNs recognize the value the oversight provides in the form of education, improving patient safety, meeting required regulatory compliance, improving relationships between physician proceduralists and nursing staff, updating related policies, resolving issues and challenges, organizing the process, improving efficiency, and preparing for successful surveys.

CREDENTIALING NEW PS LOCATIONS

It is important that the process for establishing a new PS service location/unit be standardized across the health system and within each hospital. An initial application should be submitted by the physicians and nurses who wish to perform PS. The application should include a checklist of requirements that are vetted by the physician and nursing leaderships of that service (to enhance awareness and garner support). This application is then submitted to the PS executive committee for review. An approval by the executive committee is issued after a physical walk-through of that area and a meeting with the staff to verify that the requirements (Supplemental Digital Content 2, Table 2, https://links.lww.com/AA/D932) are in place for safe patient care. After approval, the new PS location can then begin to start scheduling cases and providing PS services.

Oversight Visits to Established PS Locations

The PS executive committee (all available members) conducts site visits to every location (Table 3) at regular intervals (every 1–2 years), depending on the frequency of issues and events. The purpose of the site visit is to review the quality improvement process for that particular location, strengthen the relationship between the local team and the executive committee by highlighting the resources available, and provide the location leaders the opportunity to discuss any issues and ask questions. The site visits are particularly beneficial when changes in leadership have occurred at that location.

POLICIES

The PS executive committee is responsible for issuing and maintaining the hospital PS standard operating procedure (SOP), as discussed above, that must be followed by all PS areas. When a health system includes many regional community hospitals, the executive committee should review the policies at each hospital and create one standardized PS SOP for the health system. Other related guidelines/policies (Supplemental Digital Content 3, Table 3, https://links.lww.com/AA/D933) should also be reviewed and updated in collaboration with the authors of those policies to address PS needs.

PROFESSIONALS AND PS EDUCATION

Physician Training and Privileging

Education in PS is almost always a major need and a challenge. For example, one approach taken at the authors’ institution is an hour-long presentation for the sedation teams across the health system, delivered at various departmental forums. That presentation served as the starting point for developing an online module used for new and biannual renewal of PS privileges. This online course includes education regarding patient selection, pharmacology of sedation medications, review of local sedation policies, sedation monitoring (including capnography), sedation reversal, airway management, and examples of sedation case management. This course concludes with an examination, and a passing score is needed for successful completion. This “tailored” course replaced the previously used course offered by the American Society of Anesthesiologists (ASA) (https://www.asahq.org/education-and-career/educational-and-cme-offerings/safe-sedation-training---moderate). This change was in response to proceduralists’ feedback to eliminate items covered by other locally available educational tools like informed consent, adding more in-depth education on sedation medication pharmacology, airway management, and the desire to promote and reference different aspects of the local policy compared to a more global approach offered by the ASA course.

A previous requirement for moderate sedation privileges to include basic life support (BLS) certification was changed in favor of advanced cardiovascular life support (ACLS) certification or completion of an age-appropriate equivalent course. This change was due to the aging population who have more comorbid conditions, the increased complexity of some procedures performed under PS, the guidelines published by ASA,6 and because CMS considers patient rescue as a “patient’s right.”3 This may also account for the reason that CMS is mandating this oversight in addition to the overall global increased focus on patient safety and experience.

Additional educational offerings include a hands-on advanced airway management course at the simulation center. This airway training is a requirement for deep sedation privileging and strongly encouraged for those requesting privileges for moderate sedation. The training includes the use of bag-mask ventilation, nasal/oral airway, supraglottic airway insertion, and basic laryngoscopy and intubation.

This effort was accompanied by centralizing and standardizing the PS privileging process through the office of the director of the center for PS within the anesthesiology department to ensure compliance and maintain an updated and accurate privileging database.

Table 4. - The 4 Steps for Approval of (New or Renewal) Procedural Sedation Privileges Application
1) The chair of the proceduralist’s department reviews and recommends approval based on their knowledge of the physician’s ability to provide sedation; new staff are considered for sedation privileges based on their previous training in the case of new graduates, or previous competency through personal communication, and reference letters for practicing physicians.7 For renewals, assessment of physician’s performance is the responsibility of their department’s chair with advice from the department’s quality improvement officer and DAS/designee oversight
2) The OPSA confirms completion of the biannual requirements
a. Privileging for moderate sedation: physicians will demonstrate competency through education, training, and experience in advanced resuscitative techniques appropriate to the age of patients served (eg, ACLS, PALS, and so on), and successful completion of an online sedation/analgesia training module. Certification or recertification of critical care or emergency medicine boards will be counted as fulfillment of the above requirement for 2 years from date of certification.7
b. Privileging for deep sedation: in addition to the above demonstration of competency for moderate sedation, physicians granted that the privilege of deep procedural sedation/analgesia will assure additional competency through successful completion of the institution’s airway course. If the physician’s primary privileges involve airway management (eg, emergency department physician or intensivist), then airway management competency is counted as fulfilled in the granting of deep PS privileges.
c. All such competency training and certificates shall be kept current on a 2-year cycle.
3) The DAS designee reviews all of the above in light of their knowledge of the proceduralist’s practice through site visits, committee meetings, and quality reports to recommend final approval.
4)The above 3 steps need to be completed in order for the request to be advanced to the hospital medical executive committee to grant the privileges according to the hospital privileging SOP.
Abbreviations: ACLS, advance cardiovascular life support; DAS, Director of Anesthesia Services; OPSA, Office of Professional Staff Affairs; PALS, pediatric advanced life support; PS, procedural sedation; SOP, standard operating procedure.

The application for PS privileges (new or renewal) goes through 4 steps (Table 4) before approval.

Sedation Nurse Training and Competencies

For newly hired moderate sedation RNs, the main aspect of PS training is a comprehensive clinical sedation training (proctoring) by experienced sedation RNs.

In addition, an online PS module provides comprehensive education for moderate sedation nurses on sedation, including administration and dosing of sedation and reversal medications.

The sedation RN is strongly encouraged to have ACLS certification (although some departments may require this certification regardless). Additional onsite training for RNs includes the review of the Ramsay Sedation Scale8 and completion of hands-on training of the unit/department emergency equipment. Annual competencies include completing the PS nursing online module. Ramsay Sedation scale is one example of an appropriate sedation scale; however, others may choose to use other more familiar or locally acceptable alternative scales.

In addition, a quarterly live hands-on, 2-day training course for RNs involved with moderate sedation is offered. This course is a training class for new sedation RNs and serves as a refresher for those already practicing moderate sedation. The course includes didactic education, hands-on, case-based simulation including medical emergencies, small group problem-based learning discussions, and policy review.

Moderate sedation RNs are deemed competent by their unit leadership to monitor and administer moderate sedation medications after fulfilling all the above educational, training, and competency requirements.

RECOVERY STANDARDS

Recovery criteria should be standardized, including correction of the myth that patient discharge from the recovery room after PS is “time based,” but it is actually based on clinical parameters.9 Education to that effect may be necessary.

PATIENT DISCHARGE CRITERIA AND PROCESS

The authors encourage sedation areas to transition away from the more traditional inpatient-focused discharge tool,10 in favor of a more contemporary approach for outpatients. The older criteria served its purpose in the 1970s for discharging patients from the postanesthesia care units (PACUs) to the hospital floor, but they are inadequate with the current state of knowledge and focus on quality and patient experience. The traditional scoring tool has undergone multiple modifications, with different versions of discharge scores being proposed.11–13 More recent versions of the discharge scoring tool had some undesirable features. For example, one score was assigned to multiple items, such as vital signs collectively. Our more recent version of the phase 2 (street fit) discharge tool addressed some of the shortcomings of other published discharge tools, making it easier to interpret and execute by all parties involved, especially the PACU RNs (Supplemental Digital Content 4, Figure 1, https://links.lww.com/AA/D934). This tool provides a score based on clinical milestones to ensure safety and at the same time improve efficiency by discharging patients when they achieve the acceptable score, regardless of the time spent in the recovery room. The score is comprised of 8 items, each assigned a minimum score of 0 and a maximum score of 2. Patients are safe for discharge when they achieve a score of ≥14/16, as long as none of the items has a score of 0. If a satisfactory score is not achieved, a second score is determined whenever there is noticeable improvement in the unsatisfactory item(s); alternatively, a physician evaluation can be requested. Some of the sedation RNs spend time in other PACUs caring not only for patients recovering from PS, but also from general anesthesia. To minimize confusion and multiplicity of tools, after consultation with other anesthesiology leaders and PACU nurse managers, this discharge tool was then used institutionwide for phase 2 recovery discharge for both PS and anesthesia. It ensures that all patients are assessed for discharge using the same clinical criteria, as the end point for all of them is to be “street fit” regardless of whether the starting point is moderate sedation or general anesthesia.

Before discharge from the area, the PACU RN should provide and review with the patient and their companion the PS-related discharge instructions, in addition to procedure-specific instructions. The PS executive committee standardized these instructions at our institution as listed in Supplemental Digital Content 5, Figure 2, https://links.lww.com/AA/D935.

OVERSIGHT OF SEDATION PRACTICES: SAFETY, QUALITY, AND OUTCOMES

Safety

While there are countless opportunities in which PS oversight can enhance patient safety; capnography monitoring stands out as one great example. Our PS executive committee realized the importance of capnography monitoring as recommended by the ASA statement on basic anesthesia monitoring.14 Other professional societies have also recommended capnography monitoring to be used during moderate sedation.15–17 The rationale for the utilization of capnography in monitoring during PS is explained in our previously published article on “Capnography Monitoring in Procedural Sedation in Bronchoscopy.”18 When capnography monitoring was implemented in the IR suite, the incidence of oversedation during prone cases (previously a challenge) plummeted to nearly 0%.

Quality

“Patients first” should remain the principal goal for which all resources are invested in all areas in which PS takes place in the health system. Open communication should be promoted between proceduralists and nursing staff during preprocedure, intraprocedure, and postprocedure segments of care. Examples of open communication include the universal preprocedural check list, time out before the beginning of the procedure, and sign out at the end of the procedure. Another example is “stop the line” culture, in which all members of the team, including sedation RNs, trainees, technicians, or assistants, can speak up at any point, especially during the preprocedural checklist discussion, when there is concern regarding a patient’s condition, the procedure to be performed, equipment issues, or any other aspects of the procedure, in which proceeding has the potential to jeopardize patient safety. Such a “stop the line” call would result in immediate halt and reevaluation, reassessment, or any other necessary actions, including cancelation or escalation of care depending on the circumstances.

The PS executive committee endorses best practices for PS that ensure safety, patient satisfaction, and optimal procedural outcomes, while minimizing adverse events. The latter is monitored through documentation in the safety event reporting system. Attention is paid to each adverse event, and proper education is provided to the involved participants as needed.

Each PS area should review and document its own adverse events. The PS executive committee supports local teams as they review any adverse events for process improvement. In addition, the PS executive committee may review events that need further follow-up. Serious adverse events should go through an additional quality review process within the quality department. Lessons learned from every event should be shared with all clinical staff in the PS area where it took place. Events that are relevant to all PS areas should be shared with the enterprise PS committee.

The PS executive committee should encourage reporting of any and everything of concern to the PS team members. However, certain outcomes (Supplemental Digital Content 6, Table 4, https://links.lww.com/AA/D936) derived from those required by CMS and recommended by ASA and its Anesthesia Quality Institute must be reported.7,19 In addition to monitoring and reviewing self-reported events, the PS executive committee should seek other sources of data to overcome the common “underreporting” challenge, such as pharmacy files of dispensed sedation reversal medications in different sedation locations as well as emergency rescue team calls originating from those locations.

We have observed improvements in quality and patient safety with our oversight efforts. An example is the results of promoting capnography monitoring as mentioned above. Moreover, while we have seen an improvement in underreporting, the number and percentage of reported events remained almost unchanged, ranging from 0.08% to 0.11% (mostly successfully managed oversedation events), in the >90,000 PS patients served annually at our institution, indicating improvement overall.

PS DOCUMENTATION, AUDITING, AND COMPLIANCE

Documentation in PS was an identified area for improvement, as 100% compliance with documentation at different phases has been our goal. Our initial attempt included standardizing the paper “sedation record.” While there is no prescribed number of cases to audit, we decided to audit at least 10% of all sedation records for locations that perform a large number and 100% for locations with few PS cases. We subsequently upgraded the PS documentation from a paper record to an electronic one compatible with our electronic medical record (EMR). This provided the opportunity for improvement in auditing documentation compliance with our policies. Audit results are shared with local teams, physician leaders, nursing leaders, quality directors, and our accreditation department to review and set appropriate plans and actions to improve compliance.

Our external surveyors have commented over the years, praising the process, practice, and compliance. These same surveyors have been able to identify a few missing items in the documentation of our preprocedure evaluation, which has helped to improve our overall program. We are currently working toward the goal of electronic auditing of all PS electronic records, leveraging a highly functional and validated dashboard.

Regulatory Compliance

PS locations are required to follow the CMS CoPs. If the hospital is accredited by an organization that has a deemed status with CMS, they are also required to follow all requirements of the accrediting organizations. Deemed status is given by CMS to the accreditation organizations after they have been found to meet or exceed the CMS hospital CoPs such as The Joint Commission (TJC).20

It is important that institutions follow their own state regulations. State surveyors can conduct onsite surveys for both CMS and the state. Surveyors often arrive unannounced to conduct an onsite survey for accreditation certification or recertification, a validation survey, a complaint survey, or a state survey. PS is a high-risk activity that is evaluated for most surveys.

A quick review of TJC’s “All Accreditation Programs Survey Activity Guide,”21 reveals that organizations are required to provide a list of sites where deep or moderate sedation is in use and lists of procedures (eg, cardiac catheterization, endoscopy lab, etc), including location of procedure and time. Therefore, it is very important to follow all regulations all the time, not only to be survey ready, but more importantly, to provide safe high-quality care.

PATIENTS AND PROFESSIONAL SATISFACTION

PS 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, especially in those areas that serve out-of-town/-state patients. To address this challenge, the anesthesiology department provided education on managing common causes of cancellation. We use an online system screening tool similar to the one that can be used for surgical patients to also screen the patients for the PS services. This system prompts the patient to answer a series of questions (self-reporting) about their medical history, and the summary of their answers is posted to the EMR, where it is evaluated (screened) by the proceduralist/designee. This approach identifies clinical risks that can be addressed locally, such as pulmonary and/or cardiology consultations for optimization of the patient’s medical condition before the procedure of select patients. We observed substantially decreased cancellation rates, improved patient and team satisfaction, and improved operational efficiencies.

“SURVIVING A SURVEY”

While this is a much larger topic beyond the scope of this article, it is worth highlighting the items that a surveyor may ask for, and thus, the PS committee should have readily available:

  1. Organizational chart
  2. Criteria for privileging
  3. Ability to identify specific privileges
  4. Compliance with local policies
  5. Case counts (monthly/proceduralist/type of sedation, and moderate versus deep)
  6. List of all sites that perform PS
  7. Evidence of completed education and competencies for all participating in PS
  8. Confirmation of a robust quality review/improvement process

CONTINUING EDUCATION

A PS website should be established on which a repository of internal and external resources, such as PS locations, a leadership database, local policies, national guidelines, related published literature, and an archive of all enterprise PS committee meetings and presentations can be posted and made available to all employees. Case presentations are often utilized for teaching purposes from which lessons learned are emphasized and disseminated throughout the enterprise. The educational scope should not span only sedation and reversal medications, but also safe monitoring and resuscitation.

TRAINEE (PROCEDURALIST) SEDATION EDUCATION AND HANDS-ON TRAINING STANDARDS

At academic centers, teaching physician trainees in all specialties is a core mission. Responsibility for training and its documentation resides with training program directors at different departments.

Proposed competencies for trainees include:

  1. BLS and ACLS (generally fellows and residents are already certified)
  2. PS online training module
  3. Proctored PS cases in the specialty (number of cases is to be determined by the program director)
    • a. as the proceduralist, including ordering sedation medications, and, separately,
    • b. as a sedation monitoring clinician (at the sedation nurse’s end); the goal is to be familiar with the effects of the ordered sedation medications
  4. A hands-on advanced airway course is recommended

CHALLENGES IN IMPLEMENTING A HIGH-QUALITY OVERSIGHT PROGRAM

  • 1. Definitions of levels of sedation and the anesthesia continuum:

Some hospitals and/or clinicians may not be clear on the differences between levels of sedation. The CMS-declared definitions4 are based on those according to ASA.22 The policy specifications should follow the intended level of sedation with the understanding that a patient may slip deeper than intended into a level of sedation, at which point the procedure and sedation should be paused and the patient supported until she/he returns to the intended level of sedation.

  • 2. What sedation levels and/or procedures or circumstances should be excluded from the PS policy:

With patient safety in mind, exclusions may include:

  • a. Patients not undergoing a diagnostic or therapeutic procedure (eg, postoperative analgesia and treatment of insomnia and/or anxiety)
  • b. Single-dose drug used as anxiolytic administered by any route (during which the patient retains a normal response to verbal stimulation and airway/ventilation is unaffected) to perform minimal procedures such as dressing change
  • c. Otherwise healthy patients receiving local and/or topical anesthesia, and no other sedative or analgesic agents administered by any route
  • d. Patients who are mechanically ventilated in a critical care environment
  • e. Patients requiring emergency tracheal intubation or emergency cardioversion
  • f. Perioperative management of patients undergoing general anesthesia, spinal, epidural, or major regional anesthesia, and PS in any location where a member of the anesthesiology department administers monitored anesthesia care (MAC) sedation
  • 3. Patient selection: who is considered a suitable candidate for PS?

The responsible physician proceduralist will determine whether the patient is appropriate for PS. This determination is to be based on the intended procedure, the level of sedation/analgesia required to complete the procedure, and the patient’s medical status. An ASA physical status score is determined and documented as part of a comprehensive evaluation, including a history and physical (H&P) to determine patient suitability for PS.

Consultation from a member of the anesthesiology department is based on any factor the responsible physician determines will enhance patient care and safety through the presence of an anesthesiologist. Examples include:

  • Patients with severe systemic disease (eg, severe obstructive pulmonary disease, coronary artery disease, and congestive heart failure) in which PS and/or complexity of the procedure would reduce the patients reserve resulting in a threat to life
  • Patients with significant oxygenation or anatomic airway/ventilation abnormalities as noted by the H&P
  • Patients for whom the expected procedure will require sedation levels greater than that covered in the policy (moderate/deep)
  • 4) PS oversight funding:

PS oversight is a costly endeavor that requires resources and personnel. Moreover, it is a CMS CoP mandate that is not associated with a separately billable service and directly impacts the hospital accreditation status, as well as patient safety and the overall cost of care. For these reasons, resources needed for this oversight should be provided by the hospital and not by the anesthesiology department.

  • 5) Enforcing PS policy and compliance:

The role of the PS executive committee not only is organizing, educating, and setting standards, but it also helps clinicians become compliant by centrally monitoring their documentation compliance and quality monitoring as well. While proceduralists are responsible for complying with set standards, ignoring compliance or any deviation from standards as identified by the PS committee is escalated to their department chairs who have the primary responsibility for corrective actions with regard to their staff performance. The chair of the PS oversight may delay or not approve the PS privileges when criteria are not met for initial or reprivileging and may also rescind active privileges for patient safety concerns.

  • 6) How to encourage attendance at PS committee meetings?

This meeting should be conveniently scheduled and limited to 1 hour, the frequency of which depends on the local needs, perhaps every other month if adequate. It should also be offered as a virtual option for all members, especially desirable for those physically located and practicing outside of the main hospital location. Moreover, the slides/documents presented should be published along with a video recording of the meeting to the PS website when feasible to be available for viewing at a later time.

Attracting participation can be easily achieved by demonstrating value to this limited time with very concise and important updates and issues. Despite the fact that different departments have different perspectives and procedures, sedation is essentially the same. The same challenges and quality issues are typically seen in all departments. The meeting should provide an open forum and a “listening ear” to the challenges of individual constituents, for which the executive committee can work to provide solutions and present those solutions at the next meeting.

COMMUNITY AWARENESS OF PS SAFETY

Efforts to increase public awareness of PS safety could be accomplished through social media23 and/or through a public awareness campaign as hosted by the health system. One example is a “patient safety fair,” where the PS executive committee can demonstrate to all employees, patients, and the public how to monitor pulse oximetry and capnography during sedation.

BENEFITS OF PS OVERSIGHT

While this CMS mandate is usually met with skepticism initially, oversight by the anesthesiology department can be a rewarding and gratifying endeavor that is celebrated and cherished. This is due to its numerous benefits; in addition to what is mentioned above, these also include:

  • Improved safety of care
  • Improved patient and team satisfaction
  • Avoidance of complications (resulting in cost savings and potential litigations)
  • Appropriate preprocedural consultations with other specialists (eg, pulmonologists and cardiologists)
  • Increased operational efficiency
  • Appropriate referrals for anesthesia care

SUMMARY

Anesthesiology-mandated oversight for PS is an important patient safety and quality-of-care issue, as highlighted by the CMS CoP publication addressing PS. Simply writing or rewriting a PS policy only is not sufficient. It is important that anesthesiology departments embrace the responsibility and provide leadership in their own hospitals and institutions to promote patient safety first and achieve compliance with established standards. Education, training, and quality monitoring are important to the success of establishing and maintaining competency and safe patient care. The oversight structure and procedures will vary from hospital to hospital depending on the size, the number of locations, and local needs; however, the principles, especially CMS expectations, will be identical. Hospitals should provide the necessary resources to support the DAS to implement and provide an effective oversight program to satisfy this CMS CoP. It is an ongoing process that requires maintenance, monitoring, and continuous improvement.

DISCLOSURES

Name: Basem B. Abdelmalak, MD, FASA, SAMBA-F.

Contribution: This author helped conceptualize, draft, critically review, and edit this manuscript.

Conflicts of Interest: B. B. Abdelmalak receives royalties from 2 textbooks he coedited: Anesthesia for Otolaryngologic Surgery and Clinical Airway Management: An Illustrated Case-Based Approach, published by Cambridge University Press, London, UK. B. B. Abdelmalak is a Continuing Medical Education (CME) speaker with Medtronic Inc.

Name: Talal Adhami, MD, HCMBA, AGAF, FAASLD.

Contribution: This author helped draft, critically review, and edit this manuscript.

Conflicts of Interest: None.

Name: Wendy Simmons, MSN, RN.

Contribution: This author helped draft, critically review, and edit this manuscript.

Conflicts of Interest: None.

Name: Patricia Menendez, MS, BSN, RN, HACP.

Contribution: This author helped draft, critically review, and edit this manuscript.

Conflicts of Interest: P. Menendez is a former Joint Commission Hospital/Ambulatory surveyor.

Name: Elizabeth Haggerty, MLRHR, MBA.

Contribution: This author helped draft, critically review, and edit this manuscript.

Conflicts of Interest: None.

Name: Christopher A. Troianos, MD, FASE, FASA.

Contribution: This author helped critically review and edit this manuscript.

Conflicts of Interest: None.

This manuscript was handled by: Girish P. Joshi, MBBS, MD, FFARCSI.

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