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    Senate Bill 674

     m HEALING ARTS: OUTPATIENT SETTINGS Author Senator Gloria Negrete McLeod

    ISSUE augmentation, liposuction, nose reshaping,

     eyelid surgery, and tummy tuck. SB 674 attempts to guarantee the public’s safety by strengthening the regulation and You have heard of what happened to oversight of fertility clinics and surgical Kanye West’s mother, Donda West, she centers performing cosmetic procedures, died less than 24 hours after undergoing and ensures that quality of care standards several surgeries at an outpatient clinic. are in place at these clinics and checked There is little oversight of these outpatient by the appropriate credentialing agency. clinics, including the clinic where Ms. West

     had her procedures done. Recent events involving a mother who gave birth to octuplets revealed that fertility In addition, less invasive surgeries such as clinics operate with little or no state laser surgery and Botox are increasingly oversight. A clinic that assists women in becoming popular. Medical spas or any reproductive technology should facilities offering botox injections, laser hair operate under specified standards, removal, and microdermabrasion are guidelines and procedures. Since fertility emerging in malls, city office buildings, and clinics are primarily physician owned and store fronts across the country. Although operated, this bill would require these the federal Food and Drug Administration clinics to be accredited by an accrediting oversees the safety of the machines and agency approved by the Medical Board of skin-care products used, there is little California. The Medical Board will be regulation of these medical spas to required to adopt standards for the guarantee that practitioners in these accreditation of fertility clinics’ operations. facilities are administering treatments

     safely and patients are aware of the In addition, in California, cosmetic surgery potential risks associated with any can be performed by any licensed treatment. physician, and many physicians, who may or may not be trained in cosmetic procedures are conducting increasingly Ecomplex procedures in settings outside of

    hospitals such as outpatient surgery XISTING LAW centers and doctors’ offices. The number of cosmetic procedures performed in the Advertising: United States is increasing at an alarming rate. According to the American Society of 1) Makes it unlawful for health care Plastic Surgeons (ASPS), over 12 million licensees to disseminate or procedures were performed in 2008. The cause to be disseminated any top five procedures were: breast form of public communication, as

    defined, containing false,

    fraudulent, misleading, deceptive

    statement, or image, as specified,

     Office of Senator Gloria Negrete McLeod ? SB 674 Fact Sheet ? Page 1

    to induce the provision of ensure competency, guidelines services or the rendering of a for standardized procedures and product relating to a professional protocols that address patient practice or business for which he selection, education, instruction or she is licensed, and provides and informed consent, use of that any person so licensed who topical agents, and procedures violates this provision is guilty of to be followed in the event of a misdemeanor and that such complications or side effects violation shall constitute good from treatment and procedures cause for revocation or for governing emergency and suspension of his or her license urgent care situations. or other disciplinary action including an administrative fine 3) Requires the MBC and the BRN not to exceed $10,000. to promulgate regulations to

     implement changes determined

    2) Requires a health care to be necessary with regard to practitioner to disclose, while the use of laser or intense pulse working, his or her name and light devices for elective license status on a specified cosmetic procedures by name tag at least 18-point type physicians and surgeons, nurses but provides if a health care and physicians assistants. practitioner is in a practice or office where their license is Fertility Clinics: prominently displayed, they may opt to not wear a name tag. 1) Requires health care providers

     to give infertility patients the

    Medical Spas/Facilities that use necessary information to make

    Laser or Intense Pulse Light an informed and voluntary

    Device: choice regarding the disposition

     of any human embryos

    1) Requires the MBC in conjunction remaining following fertility with the Board of Registered treatment. Nursing (BRN), and in consultation with the Physician 2) Requires a physician and Assistant Committee (PAC) and surgeon, prior to providing professionals in the field, to assisted oocyte production or review issues and problems any alternative method of relating to the use of laser or ovarian retrieval for the purpose intense light pulse devices for of medical research or elective cosmetic procedures by development of medical physicians and surgeons, nurses, therapies, to obtain written and and physician assistants. oral informed consent for the

     procedure. Failure to obtain

    2) Specifies that the review written informed consent conducted by the MBC, the BRN constitutes unprofessional and the PAC shall include the conduct, as specified. appropriate level of physician supervision needed, the appropriate level of training to

     Office of Senator Gloria Negrete McLeod ? SB 674 Fact Sheet ? Page 2

    Outpatient Settings:

     2) Requires the DPH to perform 1) Provides that no physician or periodic inspections of hospitals

    surgeon may perform as part of licensure.

    procedures in an outpatient

    setting, as defined, using

    anesthesia, unless accredited THIS BILL pursuant to the Health and Safety Code, Section 1248 et 1) Includes in the existing law definition of seq. outpatient settings fertility clinics. 2) Defines “outpatient setting” as 2) Makes various changes regarding the any facility, clinic, unlicensed approval, oversight and inspection of clinic, center, office, or other outpatient settings by the Medical setting that is not part of a Board of California (MBC) and general acute care facility where accreditation agencies approved by the anesthesia is used. MBC, and in developing a plan of corrective action for any deficiencies 3) Defines “accrediting agency” as found by the accreditation agencies or a public or private organization the MBC during inspections. that is approved to issue certificates of accreditation to 3) Requires outpatient settings to submit outpatient settings by the MBC for approval by an accrediting agency pursuant to specified at the time of accreditation of a detailed requirements. plan, standardized procedures, and protocols to be followed in the event of 4) Requires the MBC to adopt serious complications or side effects standards for accreditation of from surgery that would place a patient outpatient settings, as defined, at high risk for injury or harm and to and in approving accreditation govern emergency and urgent care agencies to perform accredit-situations. tation of outpatient settings, ensure that the certification 4) Requires the MBC to adopt regulations program shall, at a minimum, on the appropriate level of physician include standards for specified availability necessary within clinics aspects of settings’ operations. using laser or intense pulse light devices, and to establish as one of its Peer Review: priorities the investigation of unlicensed activity within such clinics. 1) Provides for the professional review of specified healing arts 5) To assist consumers who are licentiates through a peer review contemplating on any cosmetic process. Existing law defines procedure, this bill requires the MBC to the term “peer review body” as post on its website a fact sheet to including a medical or educate the public about cosmetic professional staff of any health surgery, and the risks involved with care facility or clinic licensed by such surgeries. the State Department of Public Health.

     Office of Senator Gloria Negrete McLeod ? SB 674 Fact Sheet ? Page 3

6) Requires that any advertising by

    specified health care statement from a health care practitioners include specific practitioner to a patient, or professional designation appointment reminder from a following the health care health care practitioner to a practitioners’ name. patient. Also excludes from the requirement in #1) above any 7) Clarifies that a health care advertisement or business card practitioner who is working in an disseminated by a health care outpatient setting or clinic as service plan relating to defined, must disclose their type contracted providers, as of license, instead of license specified. status, on a name or verbally to patients. 3) Specifies that the requirement in 8) Requires the Department of Public #1) does not apply until January Health, when conducting an inspection 1, 2011 to any advertisement of an acute care hospital, to inspect the that is published annually and peer review process utilized by the prior to July 1, 2010. hospital. 4) Clarifies that a health care Spractitioner who is working in an

    UMMARY outpatient setting or clinic as

     defined, must disclose their type This bill, within the Business and of license, instead of license Professions Code: status, on a name or verbally to

     patients. 1) Requires that any advertising by

    a chiropractor, dentist, physician 5) Requires the MBC to adopt

    and surgeon, osteopathic regulations, by July 1, 2010,

    physician and surgeon, podiatrist, regarding the appropriate level of

    registered nurse, licensed physician availability needed

    vocational nurse, psychologist, within clinics or other settings

    optometrist, physician assistant using laser or intense pulse light

    and naturopathic doctor include devices for elective cosmetic

    specific professional designation procedures.

    following the health care

    practitioner’s name. 6) Requires the MBC to post on its

     website an easy to understand 2) Defines advertising for purposes fact sheet to educate the public

    of #1) above to include about cosmetic surgery and

    communication by means of mail, procedures, including their risks.

    television, radio, motion picture, Included with the fact sheet shall

    newspaper, book, directory, be a comprehensive list of

    Internet or other electronic questions for patients to ask their

    communication. Excludes from physician and surgeon regarding

    the definition of advertisement cosmetic surgery.

    the following: medical directory

    released by a health care service

    plan or a health insurer, a billing

     Office of Senator Gloria Negrete McLeod ? SB 674 Fact Sheet ? Page 4

    This bill, within the Health and every three years and as often Safety Code, Section 1248 et seq.: as necessary to ensure the

     quality of care provided.

    1) Includes the in the existing law

    definition of outpatient setting 6) Requires reports on the results

    facilities that offer in vitro of each inspection to be kept on

    fertilization or assisted file with the MBC or the

    reproduction technology accrediting agency along with

    treatments. the plan of correction and the

     outpatient setting comments and 2) Requires as part of the that the inspection report may

    standards for operation and include a recommendation for re-

    approval of an outpatient setting inspection, and that all

    that the outpatient setting submit inspection reports, lists of

    for approval by an accrediting deficiencies, and plans of

    agency at the time of correction be public records

    accreditation, a detailed plan, open to public inspection.

    standardized procedures, and

    protocols to be followed in the 7) Deletes the requirement that the

    event of serious complications or MBC or the accrediting agency

    side effects from surgery, as give reasonable prior notice and

    specified. present proper identification prior

     to an inspection.

    3) Requires the MBC to notify the

    public whether a setting is 8) Requires rather than just

    accredited, certified, or licensed, authorize the MBC to evaluate

    or the setting’s accreditation, the performance of an approved

    certification, or license has been accreditation agency no less

    revoked, suspended or placed than every three years.

    on probation, or the setting has

    received a reprimand by the 9) Provides that the outpatient

    accreditation agency. setting shall agree with the

     accrediting agency upon a plan 4) Requires an accrediting agency of correction when they receive a

    to immediately report to the MBC notice of any deficiencies from

    if an outpatient setting’s the accreditation agency and

    certificate for accreditation has that during the time of correction,

    been denied. the list of deficiencies and the

     plan of correction shall be 5) Requires that every outpatient conspicuously posted in a clinic

    setting which is accredited to be location accessible to public view.

    periodically inspected by the

    MBC or the accrediting agency. 10) Requires DPH, during its routine

    Requires that the frequency of state periodic inspection of an

    inspections depend upon the acute care hospital, as specified,

    type and complexity of the to also inspect the peer review

    outpatient setting to be inspected, process utilized by the hospital.

    and that inspections be

    conducted no less than once

     Office of Senator Gloria Negrete McLeod ? SB 674 Fact Sheet ? Page 5

    Q & A be noted that the application of botox or

     other similar products and the use of ADVERTISING SECTION: intense pulse light devices is the practice

     of medicine and as such when these Why is it necessary to clarify that a facilities are administering these health care practitioner provide the type treatments, we need to ensure that they of license, instead of license status, on are administered safety and patients are a name tag or verbally to patients? aware of the potential risks associated with

     them. The most effective way to ensure It is becoming increasingly difficult for the this is defining the level of physician public to identify the license, specialty availability at these settings. designation, and training of health care professionals who practice their skills. Why is a fact sheet necessary? MBC Currently, there is widespread misleading has posted on its website a statement health care advertising and website on what consumers need to know about information conveyed to the public for a medical spa. these practitioners to attract new and lucrative businesses. This leads to The MBC has posted on its Website a considerable confusion among the public statement on what consumers need to and the public’s welfare is better served know about medspa, and the MBC is in the and protected if they are informed about process of revising it to include a statement the skill level of the professional being indicating that an examination must be considered. conducted before treatments are

     performed. The current statement is a How do you respond to the claim that good starting point. But, more needs to be your bill is requiring the MBC to be an done to further educate the public. SB 674 advertising police? required a comprehensive list of questions

     for patients to ask their physician and MBC is already an advertising police. It is surgeon regarding cosmetic surgery. part of MBC’s job to ensure that advertising does not contain communication that is FERTILITY CLINICS:

    false, fraudulent, misleading or a deceptive statement. In addition, current law Why is it necessary to include fertility specifies what advertisements should and clinics in the definition of outpatient should not contain. This bill is only settings? attempting to further educate the public that only those with proper credentials or After the controversy erupted involving a degree could claim such information. woman who gave birth to octuplets, it has

     come to my attention that fertility clinics Why is it necessary to require the MBC operate with little or no regulatory oversight. to adopt regulations on medical Fertility clinics that are not associated with spas/laser clinics. hospitals are not licensed by the

     Department of Public Health or accredited SB 674 contains provisions requiring the by any accrediting agencies. Most of these MBC to adopt regulations regarding the fertility clinics are physician-owned and it is appropriate level of physician availability appropriate that they be accredited by needed within clinics or other settings accrediting agencies approved by the using laser or intense pulse light devices Medical Board. Through accreditation, for elective cosmetic procedures. It should fertility clinics would be subject to

     Office of Senator Gloria Negrete McLeod ? SB 674 Fact Sheet ? Page 6

standards and guidelines much like many

    In addition, people are dying after surgical clinics.

    undergoing procedures at outpatient clinics

    and something needs to be done to ensure OUTPATIENT SETTINGS: the safety of the public when they decide to undergo procedures at these clinics. Why is SB 674 even more critical now in requiring additional standards and In addition, if an accrediting agency issues oversight and regular inspections of a reprimand on an outpatient clinic or if a outpatient setting/outpatient clinics? clinic’s certification, accreditation or license has been suspended or revoked, the MBC With the Appellate Court’s decision in needs to know. Afterall, the MBC’s role in Capen v. Shewry (155 Cal.App.4th 378), approving these accrediting agencies is the

    there has been confusion as to the protection of the public’s health and safety. appropriate level of jurisdiction that the

    Department of Public Health (DPH) has

    over Physician owned outpatient settings. SUPPORT For now DPH has issued a letter indicating that they no longer have jurisdiction over None on file these types of clinics. Therefore, these clinics will now have to be accredited by an OPPOSITION accrediting agency. The Medical Board of California is responsible for approving the American Nurses Association/California accrediting agencies and taking any (4/14/09). appropriate action against the physician if they violate the requirements of the Saccrediting agency. The requirements in TATUS this measure complement the licensing

    requirements of DPH by assuring that Introduced on February 27, 2009 appropriate standards are adopted and Amended on April 2, 2009 maintained by the clinics in dealing with

    both pre- and post-operative procedures, FOR MORE INFORMATION and that inspections are conducted on a regular basis by the accrediting agency. Contact: Rosielyn A. Pulmano SB 674 bill is proposing to make the Consultant inspections depend on the type and (916) 651-4104 complexity of the outpatient setting, and have them done at least once every three years. MBC does not do the inspections and relies on these accrediting agencies to ensure that these facilities are safe. In lieu

    of direct licensing by the California

    Department of Public Health, the MBC or

    any other agency for that matter, these

    physician-owned clinics must adhere to

    guidelines to improve and ensure quality

    and effectiveness of medical procedures.

     Office of Senator Gloria Negrete McLeod ? SB 674 Fact Sheet ? Page 7

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