Outpatient Surgery Settings

Business and Professions Code section 2216.3 requires that accredited outpatient surgery settings report adverse events to the Board no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, no later than 24 hours after the adverse event has been detected.

• December 29, 2017 Letter
• Adverse Event Reporting Form for Accredited Outpatient Surgery Settings

Do outpatient surgery settings or ambulatory surgery centers have to be accredited, licensed or certified?

In order to protect consumers, the Legislature passed various laws to prevent surgeries from being conducted in unregulated out-of-hospital settings. California law prohibits physicians from performing some outpatient surgeries, unless they are performed in an accredited, licensed, or certified setting. Specifically, if the surgical procedure requires anesthesia to be administered in doses that have the probability of placing a patient at risk for loss of the patient's life-preserving protective reflexes, then the surgery must be performed in an accredited, licensed, or certified setting.

If the surgery only requires local anesthesia or a peripheral nerve block (complying with the community standard of practice), or if the setting administers anxiolytics (anti- anxiety medications) or analgesics (“pain killers”) in doses that do not place the patient at risk for loss of life-preserving protective reflexes, then the surgery does not have to be performed in an accredited, licensed, or certified setting.

Where can outpatient surgery take place?

Outpatient surgery, as described above, may take place at any of the settings listed below. Questions or complaints about an individual facility should be directed to the appropriate regulating agency.

• An outpatient setting that is accredited by an accreditation agency approved by the Medical Board of California
• A surgical clinic licensed by the California Department of Public Health
• An ambulatory surgical center certified by the Center for Medicare and Medicaid Services to participate in the Medicare program
• Other approved settings (see Health & Safety Code Section 1248.1)

The Medical Board of California only has jurisdiction over the accredited outpatient surgery settings in that the Board approves the accreditation agencies that inspect and accredit these settings.

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How do I find out if an outpatient surgery setting is accredited by one of the Board’s approved accreditation agencies?

To determine whether a specific setting is accredited for outpatient surgery by one of the Board’s approved accrediting agencies, click on this link:

You will be able to look up a setting by either its name or its owners.

After locating the setting in the database, make sure you click on the see if the setting’s accreditation status is current, delinquent, suspended, on probation, or revoked.

The Board’s list includes information on whether the setting's accreditation is:

• Current;
• Revoked, suspended, or placed on probation; and
• Whether the setting has received a reprimand by the accreditation agency.

Information is also provided on:

• Name, address, and telephone number of any owners, and their medical license numbers;
• Name and address of the facility;
• The name and telephone number of the accreditation agency that has accredited the setting; and
• The effective and expiration dates of the accreditation.

Note: The Board’s list does include some outpatient surgery settings that have been accredited pursuant to the Centers for Medicare and Medicaid Services (CMS) requirements; this information was provided as a courtesy to the Board by some of the Board’s approved accreditation agencies who also perform accreditation services for CMS. The Board’s list does not include all CMS accredited settings since CMS has more approved accreditation agencies than the Board. For a complete list of accredited CMS settings, contact CMS.

Disclaimer: The information contained in the Outpatient Surgery Setting Database has been received from an approved accreditation agency. The Board cannot guarantee the accuracy of the information provided. Upon receipt of updated information from an accreditation agency, the information will be made available in the database.

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What if I can’t find the outpatient surgery setting on the Board’s list?

Not all outpatient surgery settings are required to appear on the Board’s list. For example, Medicare/Medicaid certified outpatient settings that are regulated by the Federal Government’s Center for Medicare/Medicaid Services (CMS) and surgical clinics licensed by the California Department of Public Health’s Licensing and Certification Program are not required to be accredited by one of the Board’s approved accreditation agencies. For a complete list of surgery settings exempt from this requirement, click on this link: Types of Settings Not Required to Appear On List.

If you can’t find the surgery setting on the Board’s list, please contact CMS or the California Department of Public Health to determine if the setting is CMS certified or licensed:

• Medicare/Medicaid certified outpatient surgery settings regulated by the Federal Government’s Center for Medicare/ Medicaid Services (CMS). You may contact CMS’s Division of Survey & Certification to determine the certification status of an ambulatory surgical center (Email address: ROSFOSO@cms.hhs.gov; phone number 415-744-3696).
• Outpatient settings licensed by the California Department of Public Health – Licensing & Certification Program (contact the appropriate Regional District Office to check on a specific outpatient location).

If you cannot find the outpatient surgery setting after checking the Board’s list, and contacting CMS and the California Department of Public Health, and the outpatient surgery setting is performing surgery using anesthesia in doses that have the probability of placing a patient at risk for loss of life-preserving reflexes, please file a complaint with the Medical Board using the Consumer Complaint Form.

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Which accreditation agencies have been approved by the board?

The Board is required to maintain a list of accredited outpatient settings from the information provided by the accreditation agencies approved by the Board. The Board currently approves the following accreditation agencies:

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What are the standards for an outpatient setting to become accredited?

California Health and Safety Code Section 1248.15 details the standards required for an outpatient surgery setting to become accredited. The Board’s approved accreditation agencies verify that each setting meets these standards before awarding accreditation. The approved accreditation agency must inspect each setting at least once every three years.

If the results of the inspection conclude that the setting is out of compliance with the standards, the accreditation agency must issue a deficiency report and may: 1) require correction; 2) issue a reprimand; 3) place the setting on probation; or 4) suspend or revoke the accreditation. The accreditation agency must issue a report to the Board within 24 hours if the setting has been issued a reprimand, been placed on probation, or had its accreditation suspended or revoked. This information is then posted on the Board’s website where it is available to the public. In addition, if the accreditation agency identifies deficiencies related to patient safety (e.g., quality of care provided, anesthesia services, pharmaceutical services, etc.), this information is forwarded to the Board’s Central Complaint Unit to initiate and refer for formal investigation.

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What if I have a complaint about an outpatient setting?

Complaints about an outpatient surgery setting that is accredited by an accreditation agency recognized by the Board may be submitted directly to the Medical Board.

Note: When completing the complaint form, please put the name of the outpatient setting in the “Other” box.

• Medical Board Consumer Complaint Form
• Medical Board Spanish Consumer Complaint Form

For complaints regarding a CMS certified setting or a setting licensed by the Department of Public Health:

• CMS- Accrediting Organization Complaint Contacts
• Department of Public Health Healthcare Facility Complaint Form

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What happens after I submit a complaint?

• View a diagram of the outpatient surgery complaint process

If the Board receives a consumer complaint about an outpatient surgery setting that is non-accredited, unlicensed, and not CMS certified, but is performing surgical procedures using a level of anesthesia requiring the facility to be accredited, licensed, or certified, it is referred to the appropriate Medical Board District Office for investigation. If the consumer complaint is about setting that is accredited, the Board forwards the complaint to the appropriate accreditation agency for investigation; if public safety is in jeopardy, an immediate inspection is initiated. After the accreditation agency has completed its investigation or inspection, they submit their findings to the Board for review and posting, if appropriate. For complaints that pose an immediate risk to the public, the accreditation agency must submit their findings within five business days; all other complaint investigations must be submitted to the Board within 30 days. If a physician/provider issue is identified during the scope of the investigation, these findings are forwarded to the Central Complaint Unit for review and referral for formal investigation where appropriate.

The Medical Board is required to investigate complaints related to a violation of Health and Safety Code Section 1248. Upon discovery that an outpatient surgery setting is not in compliance with a specific provision, the Board can bring action through or in conjunction with a district attorney to enjoin the outpatient setting’s operation. Accredited outpatient surgery settings are also subject to the adverse event reporting requirements under Business and Professions Code Sections 2216.3 and 2216.4.

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Frequently Asked Questions

• Outpatient Surgery Settings - FAQS

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Forms

• Adverse Event Reporting Form for Accredited Outpatient Surgery Settings
• Outpatient Surgery - Patient Death Reporting Form
• Patient Transfer Reporting Form

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Helpful Links

• Accreditation agencies approved by the Board:
  • American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF)
  • Accreditation Association for Ambulatory Health Care, Inc. (AAAHC)
  • The Joint Commission
  • The Institute for Medical Quality (IMQ)
  • American Osteopathic Association / Healthcare Facilities Accreditation Program (HFAP)
• Centers For Medicare & Medicaid Services (CMS):
  • CMS - Acronyms
  • CMS - Glossary
  • CMS - Approved Accreditation Organization Contact Information
  • CMS – Accrediting Organization Complaint Contacts
• California Department of Public Health
• Centers for Disease Control and Prevention - Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care
• Article 2.7 of Chapter 4 of Division 2 of the Business & Professions Code regarding the use of general anesthesia for dental purposes
• Article 2.8 of Chapter 4 of Division 2 of the Business & Professions Code regarding conscious sedation for dental purposes

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