Developed By: Committee on Quality Management and Departmental Administration
Last Amended: October 26, 2022 (Original Approval: October 20, 2010)
ASA believes that physician anesthesiologist participation in all deep sedation provides the safest patient care. ASA is concerned that individuals who are not anesthesia professionals may not recognize that sedation and general anesthesia are a continuum, and thus unintentionally deliver general anesthesia without having the training and experience to respond appropriately. However, ASA acknowledges that Medicare regulations provide for the administration and supervision of deep sedation by non-anesthesiologist physicians, oral surgeons, dentists, and podiatrists (“qualified non-anesthesia professionals”). This statement should guide the Director of Anesthesia Services (DAS) and those non-anesthesia professionals wishing to provide deep sedation.
There is a significant risk that patients undergoing deep sedation may slip into a state of general anesthesia as described in the American Society of Anesthesiologists Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia. Loss of consciousness and the inability to respond purposefully define general anesthesia. The need to provide positive pressure ventilation or maintain the airway with an airway device are incidental to this definition. Individuals requesting privileges to administer deep sedation must demonstrate their ability to (1) recognize that a patient has entered a state of general anesthesia and (2) maintain a patient’s vital functions until the patient has been rescued from general anesthesia and returned to an appropriate level of sedation.
These recommendations apply to granting privileges to non-anesthesia personnel who wish to administer deep sedation in all surgical and procedural clinical settings.
The granting, reappraisal, and revision of clinical privileges must be awarded on a time-limited basis in accordance with rules and regulations of the health care facility, its medical staff, organizations accrediting the health care facility, and relevant local, state, and federal governmental agencies.
At the time of this statement’s publication, CMS defines in 42 CFR 482.52(a)1 those persons who are qualified by education, training, and licensure to administer deep sedation or supervise the administration of deep sedation by nurse anesthetists. Because training is procedure-specific, the type and complexity of procedures for which the qualified person may administer or supervise deep sedation must be specified in the privileges granted.
- The Hospital Anesthesia Services Condition of Participation 42 CFR 482.52(a) limits the administration of deep sedation to “qualified personnel” within their scope of practice. CMS defines these persons as a physician anesthesiologist; non-anesthesiologist MD or DO; dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; nurse anesthetist, and Certified Anesthesiologist Assistant (CAA). See also the Ambulatory Surgery Center Condition for Coverage 42 CFR 416.42(b).
RESPONSIBILITIES OF THE CLINICIAN PROVIDING DEEP SEDATION
Any qualified person who administers and monitors deep sedation must be dedicated to that task. Therefore, the individual who administers and monitors deep sedation must be different from the individual performing the diagnostic or therapeutic procedure (see ASA Guidelines for Sedation and Analgesia by Non-anesthesiologists).
Non-anesthesiologist physicians may only delegate or supervise the administration or monitoring of deep sedation by individuals who are themselves qualified and trained to administer deep sedation and are able to recognize and rescue from general anesthesia.
EDUCATION AND TRAINING
- The qualified non-anesthesia professional must have satisfactorily completed a formal training program in (1) the safe administration of sedative and analgesic drugs used to establish a level of deep sedation and (2) rescue of patients who exhibit adverse physiologic consequences of a deeper-than-intended level of sedation.
- This training includes the didactic and performance concepts obtained through part of a recently completed Accreditation Council for Graduate Medical Education (ACGME) residency or fellowship training (e.g., within two years), or may be a separate deep sedation educational program that is accredited by Accreditation Council for Continuing Medical Education (ACCME), or equivalent, for dentists, oral surgeons, or podiatrists.
- The content required must include all appropriate ASA Statements and Guidelines, identification of procedural or patient considerations that make performance by qualified anesthesia personnel essential, and the pharmacology of all appropriate pharmaceuticals.
- A knowledge-based test is necessary to demonstrate the knowledge of concepts required to obtain privileges in an objective manner.
- A skills-based test is necessary to demonstrate competency in airway management skills necessary to rescue a patient from a deeper than intended level of sedation.
- Before granting initial privileges to administer or supervise the administration of sedative and analgesic drugs to establish a level of deep sedation, a process will be developed to evaluate the applicant’s performance and competency. For recent graduates (e.g., within two years), this may be accomplished through letters of recommendation from directors of residency or fellowship training programs that include deep sedation as part of the curriculum. For those who have been in practice since the completion of their training, performance evaluation may be accomplished through specific documentation of performance evaluation data transmitted from department heads or supervisors at the institution where the individual previously held privileges to administer deep sedation. Alternatively, the non-anesthesiologist applicant could be proctored or supervised by a qualified person privileged to administer sedative and analgesic agents to provide deep sedation. The Director of Anesthesia Services, with oversight by the facility governing body, will determine the number of cases that need to be performed and the threshold for quality metrics to determine competency in deep sedation.
- Before granting ongoing privileges to administer or supervise the administration of sedative and analgesic drugs to establish a level of deep sedation, a process will be developed to re-evaluate the practitioner’s performance at regular intervals. Re-evaluation of competency in airway management will be part of this performance evaluation. For example, the applicant’s performance could be reviewed by a qualified person who is currently privileged to administer deep sedation. The facility will establish an appropriate number of procedures that will be reviewed.
Privileging for the administration of sedative and analgesic drugs to establish a level of deep sedation will require active participation in an ongoing process that evaluates the qualified person’s clinical performance and patient care outcomes through a formal facility program of continuous performance improvement. The facility’s deep sedation performance improvement program will be developed with oversight by the Director of Anesthesia Services.
American Society of Anesthesiologists. Guide to Anesthesia Department Administration. Suggested Curriculum for Deep Sedation Training.
American Society of Anesthesiologists. Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia.
142 CFR 482.52 is available at https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-D/section-482.52 and was most recently amended Nov 27, 2007. The corresponding interpretive guidelines are available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/SCLetter11_10.pdf and were most recently updated Jan 14, 2011.