Outpatient Surgery Settings

An Outpatient Surgery Setting is 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.

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

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Outpatient surgery settings or ambulatory surgery centers must 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 outpatient surgery can 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:

 Search for an Outpatient Surgery Setting

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 exempted from having to be accredited, 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 (Contact form; phone number 415-744-3696).
• Outpatient settings licensed by the California Department of Public Health - Licensing & Certification Program. There you may search for ambulatory surgical centers.

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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Accreditation agencies that 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:

Accreditation Association for Ambulatory Health Care, Inc. (AAAHC)	3 Parkway North, Ste 201 Deerfield, IL 60015	(847) 853-6060  (847) 853-9028
Quad A	600 Central Avenue, Ste 265 Highland Park, IL, 60035	(847) 775-1970  (888) 545-5222 Toll Free  (847) 775-1985
The Joint Commission	One Renaissance Boulevard Oakbrook Terrace, IL 60181	(630) 792-5000  (630) 792-5005
Accreditation Commission for Health Care, Inc. (ACHC)	139 Weston Oaks Ct. Cary, NC 27513	(919) 785-1214  (919) 785-3011

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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

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 you submit a complaint

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 a 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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Outpatient Surgery Settings

H&S code 1248.2 requires Medical Board of California (Board) to maintain and publish a list of all accredited outpatient settings on the Board's website and provide information regarding the status of their accreditation. This portion of the statutory requirements is assigned to the Board's Licensing Program.

The Board is also required to investigate complaints related to a violation of Health and Safety Code Section 1248 and, upon discovery that an outpatient setting is not in compliance with a specific provision, bring an action through or in conjunction with a district attorney to enjoin the outpatient setting's operation. In addition, made outpatient settings subject to the adverse event reporting requirements currently required for licensing health facilities. Adverse events are reported to the Board and the setting can be subject to penalties by Public Health for failing to report adverse events.

The following identifies the responsibilities assigned in statute to pertinent entities as it relates to oversight and response to patient care concerns:

H&S Section	Accrediting Agency	Medical Board
1248.35	Every outpatient setting shall be inspected no less often than 3 years.	May inspect the setting as often as necessary and shall ensure the accrediting agency conducts the required inspection
	If the results of the inspection conclude that the setting is out of compliance, they 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 accrediting agency must report within 24 hours if the setting has been issued a reprimand, been placed on probation or had the accreditation suspended or revoked.
	Shall inspect the setting within 24 hours upon receipt of a complaint from the Board that the setting poses an immediate risk to the public	Shall receive the findings of the inspection within five business days
	Shall investigate any complaint received from the Board within 30 days	Shall receive the findings of the investigation within 30 days
		Reports on the results of any inspection shall be maintained on file and final inspection reports shall be public record open to public inspection.
1248.7		Shall investigate all complaints concerning a violation of this chapter and, where appropriate, through or in conjunction with a DA may bring action to enjoin the setting's operation.

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Complaint Process

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Enforcement Response to Action taken by an Accrediting Agency

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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 to the extent required by state or federal law
• Outpatient settings shall have a system for facility safety and emergency training requirements
• Onsite equipment, medication, and trained personnel to handle services sought or provided and to facilitate handling of any medical emergency that may arise in connection with services sought or provided
• Have a written transfer agreement with a local accredited or licensed acute care hospital, approved by the facility's medical staff
• 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 or other administrative limitations, shall have a written transfer agreement with licensees who have admitting privileges at local accredited or licensed acute care hospitals.
• Submit for approval by an accrediting agency a detailed procedural plan for handling medical emergencies that shall be reviewed at the time of accreditation. No reasonable plan shall be disapproved by the accrediting agency.
• Submit for approval by an accrediting agency a detailed plan, standardized procedures, and protocols to be followed in the event of serious complications or side effects from surgery that would place a patient at high risk for injury or harm or to govern emergency and urgent care situations. The plan shall include, at a minimum, that if a patient is being transferred to a local accredited or licensed acute care hospital, the outpatient setting shall do all of the following:
  • 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 at the time of transfer
  • 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 transferred case, the results of which shall be referred back to the outpatient setting, if deemed appropriate by the medical staff peer review committee. If the medical staff of the acute care facility determines that inappropriate care was delivered at the outpatient setting, the acute care facility's peer review outcome shall be reported, as appropriate, to the accrediting body or in accordance with existing law.
• Outpatient setting shall permit surgery by a dentist acting within their scope of practice under Chapter 4 (commencing with Section 1600) of Division 2 of the Business and Professions Code, physician and surgeon, an osteopathic physician and surgeon or podiatrist acting within their scope of practice acting within their scope of practice under Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code or the Osteopathic Initiative Act. Outpatient setting may, in its discretion, permit anesthesia service by a certified registered nurse anesthetist acting within their scope of practice under Article 7 (commencing with Section 2825) of Chapter 6 of Division 2 of the Business and Professions Code.
• Outpatient setting shall have a system for:
  • Maintaining clinical records
  • Patient care and monitoring procedures
  • Quality assessment and improvement
• 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
• Each licensee who performs procedures in an outpatient setting that requires the outpatient setting to be accredited shall be, at least every two years, peer reviewed, which shall be a process in which the basic qualifications, staff privileges, employment, medical outcomes, or professional conduct of a licensee is reviewed to make recommendations for quality improvement and education, if necessary, including when the outpatient setting has only one licensee. The peer review shall be performed by licensees who are qualified by education and experience to perform the same types of, or similar, procedures. The findings of the peer review shall be reported to the governing body, which shall determine if the licensee continues to meet the requirements described in clause (i). The process that resulted in the findings of the peer review shall be reviewed by the accrediting agency at the next survey to determine if the outpatient setting meets applicable accreditation standards pursuant to this section.
• Clinical privileges shall be periodically reappraised by the outpatient setting. The scope of procedures performed in the outpatient setting shall be periodically reviewed and amended as appropriate.
• 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 and staff
• 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 and staff
• 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 their full scope of practice if these are approved by the board to protect the public health and safety.
• 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 specified in Section 1248.
• 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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Additional Information

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