In addition to the regulations noted below, outpatient surgery organizations in California must be in compliance with the following laws:
SB 304 effective Jan 1, 2014
Requires an outpatient surgery setting, accredited pursuant to Section 1248.1 of the Health and Safety Code, to report an adverse event to the Medical Board of California (Board).
Beginning, January 1, 2014, an accredited outpatient surgery setting will be required to report adverse events, as defined in HSC Section 1279.1, 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.
The definition of an adverse event includes but is not limited to the following:
- Surgery performed on a wrong body part
- Surgery performed on the wrong patient
- The wrong surgical procedure performed on a patient
- Retention of a foreign object in a patient after surgery or other procedure
- Death during or up to 24 hours after induction of anesthesia after surgery of a normal, healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance
- Patient death or serious disability associated with the use of a contaminated drug, device, or biologic provided by the health facility
- A patient death or serious disability associated with a medication error
- A patient death or serious disability associated with a burn incurred from any source while being cared for in a health facility
The Board has established the "ADVERSE EVENT REPORTING FORM FOR ACCREDITED OUTPATIENT SURGERY SETTINGS" to be completed and submitted to the Board to fulfill this new reporting requirement as specified in Business and Professions Code Section 2216.3.
If an accredited outpatient surgery setting fails to report an adverse event, the Board may assess a civil penalty in an amount not to exceed one hundred dollars ($100) for each day that the adverse event is not reported following the initial five-day period or 24-hour period, as applicable.
The full text of SB 304 and its specific reporting requirements are available online at:
http://www.leginfo.ca.gov/pub/13-14/bill/sen/sb 0301-0350/sb 304 bill 20131003 chaptered.pdf.
The full text of HSC 1279.1 can be found at http://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=1279.1.
This adverse event reporting form can also be found on the Board's website at: http://www.mbc.ca.gov/outpatient adverse event form.pdf.
AB 595 (Speier) effective July 1, 1996
This law states: "no physician and surgeon shall perform procedures in an outpatient setting using anesthesia, except local anesthesia or peripheral nerve blocks, or both, complying 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, unless the setting is specified in Section 1248.1 of the Health and Safety Codes. Outpatient settings where anxiolytics and analgesics are administered are excluded when administered, in compliance with the community standard of practice, in doses that do not have the probability of placing the patient at risk for loss of the patient's life-preserving protective reflexes."
This law prohibits any physician or surgeon from performing surgery in an outpatient surgery setting using specified anesthesia levels unless the setting is one of an enumerated care setting(s), including a setting accredited by an approved accrediting agency, state-licensed as an outpatient surgery setting, or Medicare-certified as an ambulatory surgery center. Therefore, AB 595 required the Medical Board of California, Division of Licensing, to adopt standards for approval of accreditation agencies to perform the accreditation of outpatient surgery settings. In 2007, the AAAHC received re-approval from the Medical Board of California as a recognized accrediting agency. Organizations choosing to have their accreditation reported to the Medical Board for evidence of compliance with the law must indicate this to the AAAHC during the time of the survey application process.
Cosmetic and Outpatient Surgery Patient Protection Act (AB 271) effective January 1, 2000, which has the following requirements:
- The certificate of accreditation must be posted in a location readily visible to patients and staff.
- The name and telephone number of the accrediting agency, with instruction on the submission of complaints, must be posted in a location readily visible to patients and staff.
- Written discharge criteria must exist.
- A minimum of two staff persons must be on the premises, one of whom shall be a licensed physician and surgeon and/or a licensed health care professional with current certification in advanced cardiac life support (ACLS), as long as a patient is present who has not been discharged from supervised care. Transfer of a patient who does not meet the above required written discharge criteria to an unlicensed setting is not acceptable.
Governor Jerry Brown signed Senate Bill 100 into law. The law, which became effective on January 1, 2012, amends existing law requiring the accreditation of outpatient settings. Accreditation agencies are now required to query the Medical Board of California concerning any adverse accreditation decisions rendered against physician owners of an organization applying for accreditation. For outpatient settings that were not granted accreditation by another accrediting agency, the subsequent accreditation agency must determine that prior deficiencies were corrected. The law also requires the Medical Board to post on its website certain survey reports of accreditation agencies. At this time, the accrediting bodies are collecting information concerning physician owners; however, the Medical Board has not yet posted information online.
Liposuction extraction and postoperative care standards for outpatient settings went in effect on Feb. 20, 2003. Procedures performed under general anesthesia or intravenous sedation, or that result in the extraction of 5,000 or more cubic centimeters of total aspirate, must be performed in a hospital or an outpatient setting that is licensed, or accredited by one of the approved entities listed above.
|Health Safety Code, Ch. A.3, Sec. 1248; Bus. & Prof. Code, Secs. 2216.1, 2216.2, 2240
||Medical Board of California
Licensure, Medicare certification or accreditation is required for all outpatient settings where anesthesia is used (excluding local or peripheral nerve blocks). The Division of Licensing has approved AAAHC, among others, as state-recognized accreditation agencies. The legislation also contains a number of other requirements such as those relating to liability insurance coverage, reporting complications, adequate personnel and written discharge criteria.
Facilities must be state licensed, Medicare-certified or accredited by an accrediting agency approved by the medical board in order to charge and collect a facility fee for use of the emergency room or operating room of the facility for services provided to injured employees under the state’s workers’ compensation laws.
Currently, the California Department of Public Health will not issue a license to clinics which have any percentage of physician ownership.
|Primary Care clinics (community and free clinics that are subject to licensure)
||Health and Safety Code, Sec. 1228
||Dept of Health Services
Effective Jan 1, 2004, primary care clinics (community and free clinics that provide a safety net for underserved, uninsured, and underinsured populations) that are accredited by AAAHC or other named accrediting organization are exempt from inspection by the Department.