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EDMUND G. BROWN JR.
Governor

Health and Human Services Agency
California Department of Public Health


AFL 15-07
June 18, 2015


TO:
General Acute Care Hospitals (GACHs)
Ambulatory Surgical Centers (ASCs)

SUBJECT:
Procedural Sedation Policies and Procedures


AUTHORITY:      Title 42 Code of Federal Regulations (CFR) Sections 416.42 and 482.52


ā€‹All Facilities Letter (AFL) Summary

  • This AFL is being reissued to clarify that in California certified registered nurse anesthetists do not require physician supervision pursuant to an exemption recognized by CMS.
  • This AFL rescinds previous guidance regarding procedural sedation contained in AFL 13-17.

ā€‹This All Facilities Letter rescinds previous guidance regarding procedural sedation contained in AFL 13-17. The California Department of Public Health (CDPH) advises facilities to refer to the federal regulations and the respective interpretive guidelines provided by the Centers for Medicare and Medicaid Services (CMS) for guidance regarding sedation requirements.

In ASCs, anesthetics must be administered by:

  1. A qualified anesthesiologist; or
  2. A physician qualified to administer anesthesia, a certified registered nurse anesthetist (CRNA), or an anesthesiologist's assistant. In those cases in which a non-physician administers the anesthesia, the anesthetist must be under the supervision of the operating physician, unless exempt, and in the case of an anesthesiologist's assistant, under the supervision of an anesthesiologist.

CMS recognizes California as an opt-out state in which a CRNA may administer anesthesia without physician supervision in an ASC.

For specific requirements, please refer to Title 42 CFR section 416.42. Appendix L of the State Operations Manual (SOM), which provides interpretive guidelines from CMS, can be found at the following link:

SOM Appendix L: Ambulatory Surgical Centers

In hospitals, anesthesia must be administered by:

(1) A qualified anesthesiologist;
(2) A doctor of medicine or osteopathy (other than an anesthesiologist);
(3) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law;
(4) A CRNA who, unless exempted, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or,
(5) An anesthesiologist's assistant, who is under the supervision of an anesthesiologist who is immediately available if needed.

CMS recognizes California as an opt-out state in which a hospital may permit a CRNA to administer anesthesia without operating practitioner or anesthesiologist supervision in a hospital.

For specific requirements, please refer to Title 42 CFR section 482.52. Appendix A of the SOM, which provides interpretive guidelines from CMS, can be found at the following link:

SOM Appendix A: Survey Protocol, Regulations and Interpretive Guidelines for Hospitals

The information in this AFL is a brief summary of the information in the CFR related to the administration of anesthesia. Facilities are responsible for following all applicable laws. CDPHā€™s failure to expressly notify facilities of statutory or regulatory requirements does not relieve facilities of their responsibility for following all laws and regulations. Facilities should refer to the full text of all applicable sections of the CFR.

Please contact your district office if you have further questions.

 

Sincerely,

Original signed by Jean Iacino

Jean Iacino
Deputy Director

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