Frequently Asked Questions - Outpatient Surgery Settings

What is an Outpatient Surgery Setting or an Outpatient Ambulatory Surgery Setting?

It’s any facility, clinic, center, office or other setting that is not part of a general acute care facility, where anesthesia, except local anesthesia or peripheral nerve blocks, or both, is used in compliance with the community standard of practice in doses that, when administered have the probability of placing a patient at risk for loss of the patient’s life-preserving protective reflexes.

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Who can own an Outpatient Surgery Setting?

An Outpatient Surgery Setting can be owned by an association, corporation, firm, partnership, or individual person.

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Who can practice in an Outpatient Surgery Setting?

Licensed physicians and other medical staff who are professionally qualified and appropriately credentialed can be granted privileges. Such privileges shall be periodically reappraised by the Outpatient Surgery Setting and Accrediting Agency.

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What kinds of procedures are done in Outpatient Surgery Settings?

Any type of outpatient surgery whereby the patient care is less than 24 hours.

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Does an Outpatient Surgery Setting need to be licensed or accredited?

Anytime a medical procedure is performed under anesthesia that places patients at risk of losing their life-preserving protective reflexes, the medical procedure must be done in a licensed, certified, or accredited setting.

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What is the difference between being licensed and/or accredited?

An Outpatient Surgery Setting that is owned and operated by a physician must be accredited through one of four agencies approved by the Medical Board of California. Non-physician owned Outpatient Surgery Centers can be licensed by the California Department of Public Health or accredited by one of the Board approved Accreditation Agencies.

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What is the Medical Board of California responsible for?

The Board approves the Accrediting Agencies that accredit Outpatient Surgery Settings in California.

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What is not considered an Outpatient Surgery Setting for purposes of accreditation?

When an Outpatient Setting does not administer or use anxiolytics and analgesics, in compliance with the community standard or practice, in doses that place the patient at risk for loss of life-preserving protective reflexes it does not have to be accredited. In addition, the following settings are exempt from accreditation: ambulatory surgical centers certified pursuant to the Centers for Medicare Medicaid Services (CMS) requirements for Medicare; any clinic directly conducted, maintained and operated by the Federal Government; licensed acute care hospitals; and Outpatient Surgery Settings licensed by the California Department of Public Health.

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What are the minimum standards for accreditation of an Outpatient Surgery Setting?

Health and Safety Code Section 1248.15 defines minimum standards for accreditation of Outpatient Surgery Settings and approving Accreditation Agencies. The following are some of the accreditation standards:

  • Outpatient setting allied health staff shall be licensed or certified
  • Outpatient settings shall have a system for facility safety and emergency training
  • Onsite equipment, medication, and trained personnel to handle services sought or provided and to facilitate handling of any medical emergency
  • Have a written transfer agreement with a local accredited or licensed acute care hospital
  • Permit surgery only by a licensee who has admitting privileges at a local accredited or licensed acute care hospital, with the exception that licensees who may be precluded from having admitting privileges by their professional classification
  • Submit for approval by an accrediting agency a detailed procedural plan for handling medical emergencies
  • Submit for approval by an accrediting agency a detailed plan, standardized procedures, and protocols to be followed in the event of serious complications
  • The procedural plan for handling medical emergencies shall include at a minimum:
    • Notify individual designated by the patient in case of an emergency
    • Ensure that the mode of transfer is consistent with the patient’s medical condition
    • Ensure all relevant clinical information is documented and accompanies the patient
    • Continue to provide appropriate care to the patient until the transfer is effectuated
  • All physicians and surgeons transferring patients from an outpatient setting shall agree to cooperate with medical staff peer review process on the transfer case
  • Outpatient setting shall permit surgery by a dentist, physician and surgeon, an osteopathic physician and surgeon or podiatrist acting within his or her scope of practice
  • Outpatient setting may, in its discretion, permit anesthesia service by a certified registered nurse anesthetist acting within his or her scope of practice
  • Outpatient setting shall have a system for:
    • Maintaining clinical records
    • Patient care and monitoring procedures
    • Quality assessment
  • Members of medical staff and other practitioners who are granted clinical privileges shall be professionally qualified and appropriately credentialed
  • Outpatient setting shall grant privileges in accordance with recommendations from qualified health professionals, and credentialing standards established by the outpatient setting
  • Clinical privileges shall be periodically reappraised
  • Outpatient settings that have multiple service locations shall have all of the sites inspected by the Accrediting Agency
  • Outpatient settings shall post the certificate of accreditation in a location readily visible to patients
  • Outpatient settings shall post the name and telephone number of the accrediting agency with instructions on submission of complaints in a location readily visible to patients
  • Outpatient settings shall have a written discharge criteria
  • Outpatient settings shall have a minimum of two staff persons on the premises, one of whom shall either be a licensed physician and surgeon or a licensed health care professional with current certification in advanced cardiac life support (ACLS)
  • Transfer to an unlicensed setting of a patient who does not meet the written discharge criteria shall constitute unprofessional conduct
  • An accreditation agency may include additional standards in its determination to accredit outpatient settings
  • No accreditation standard adopted or approved by the board, and no standard included in any certification program of any accreditation agency approved by the board, shall serve to limit the ability of any allied health care practitioner to provide services within his or her full scope of practice
  • Notwithstanding this or any other provision of law, each outpatient setting may limit the privileges, or determine the privileges, within the appropriate scope of practice, that will be afforded to physicians and allied health care practitioners who practice at the facility
  • Privileges may not be arbitrarily restricted based on category of licensure
  • The Board shall adopt regulations that it deems necessary for outpatient settings that offer in vitro fertilization
  • The Board may adopt regulations it deems necessary to specify procedures that should be performed in an accredited outpatient setting for facilities or clinics that are outside the definition of outpatient setting
  • As part of the accreditation process, the accrediting agency shall conduct a reasonable investigation of the prior history of the outpatient setting, including all licensed physicians and surgeons who have an ownership interest therein, to determine whether there have been any adverse accreditation decisions rendered against them
  • An outpatient setting shall be subject to the reporting requirements in Section 1279.1 and the penalties for failure to report specified in Section 1280.4

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Who inspects and insures the safety of the Outpatient Surgery Setting?

The Accrediting Agency is responsible for inspecting and making sure the Outpatient Surgery Setting is in compliance with the minimum requirements for accreditation. These inspections will be conducted no less than once every three years by the Accrediting Agency. In addition, the Board may also inspect Outpatient Surgery Settings.

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What types of information must be posted inside the Outpatient Surgery Setting?

The Outpatient Surgery Setting’s certificate of accreditation must be posted along with the name and telephone number of that accrediting agency with instructions on submission of complaints in a location that is readily visible to patients.

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How do I know the Outpatient Surgery Setting is licensed or accredited?

Search for an Outpatient Surgery Setting on the Board’s website. You can also ask the Outpatient Surgery Setting staff regarding the facility’s accreditation. Also, check for the Outpatient Surgery Setting’s accreditation certificate that should be in a visible place at the Outpatient Setting.

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What Accreditation Agencies are approved by the Board?

The Board has approved five Accreditation Agencies:

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What is the Outpatient Surgery Setting’s responsibility to the patient?

Maintaining the Outpatient Setting in continual compliance with the minimum requirements for accreditation pursuant to California Health and Safety Code Section 1248.15 and any other additional requirements of the Accreditation Agency that accredited the setting.

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What types of problems can cause an Outpatient Surgery Center to have its accreditation denied, suspended, or revoked?

Violating the requirements pursuant to California Health and Safety Code Section 1248.15 and/or violating the additional requirements of the specific Accreditation Agency that accredited the Outpatient Surgery Setting. If accreditation is denied by the Accrediting Agency it shall provide notification of the denial to the Outpatient Surgery Setting, as well as the Board.

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Can an Outpatient Surgery Setting be closed down, and if so who can do it?

Yes, once the Medical Board of California has completed its investigation that substantiates the allegations of an illegally operating Outpatient Surgery Setting. The Board may submit an investigative report to the local District Attorney’s Office or the Office of the Attorney General to request an injunction through the court system.

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Who chooses the surgery center?

Usually your physician will determine the Outpatient Surgery Setting. The physician should have privileges to perform the specific procedure, at that specific Outpatient Surgery Setting. You can check on the accreditation of that Outpatient Surgery Setting, as well as who owns it, on the Board’s website. Also, the accreditation should be posted in plain view at the setting.

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What safety measures should be in place in case of an emergency at an Outpatient Surgery Setting?

The Outpatient Surgery Setting is required to have a detailed procedural plan to follow in case of a medical emergency. There must be a physician or another licensed health care professional with current certification in advanced cardiac life support on site. In addition, there must be a detailed plan and standardized procedures and protocols to be followed in case of serious complications. The Outpatient Surgery Setting must also have access to a licensed acute care hospital as well as a transport agreement. Feel free to ask the Outpatient Surgery Setting staff about the Outpatient Surgery Setting’s emergency protocol.

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How do I file a complaint?

Information and instructions for filing a complaint can be found on our website.

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