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Chapter 1.3. Outpatient Settings of California Health And Safety Code >> Division 2. >> Chapter 1.3.
For purposes of this chapter, the following definitions shall
apply:
(a) "Division" means the Medical Board of California. All references in this chapter to the division, the Division of Licensing of the Medical Board of California, or the Division of Medical Quality shall be deemed to refer to the Medical Board of California pursuant to Section 2002 of the Business and Professions Code.
(b) (1) "Outpatient setting" means any facility, clinic, unlicensed clinic, center, office, or other setting that is not part of a general acute care facility, as defined in Section 1250, and 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.
(2) "Outpatient setting" also means facilities that offer in vitro fertilization, as defined in subdivision (b) of Section 1374.55.
(3) "Outpatient setting" does not include, among other settings, any setting where anxiolytics and analgesics are administered, when done so 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.
(c) "Accreditation agency" means a public or private organization that is approved to issue certificates of accreditation to outpatient settings by the board pursuant to Sections 1248.15 and 1248.4.
(a) "Division" means the Medical Board of California. All references in this chapter to the division, the Division of Licensing of the Medical Board of California, or the Division of Medical Quality shall be deemed to refer to the Medical Board of California pursuant to Section 2002 of the Business and Professions Code.
(b) (1) "Outpatient setting" means any facility, clinic, unlicensed clinic, center, office, or other setting that is not part of a general acute care facility, as defined in Section 1250, and 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.
(2) "Outpatient setting" also means facilities that offer in vitro fertilization, as defined in subdivision (b) of Section 1374.55.
(3) "Outpatient setting" does not include, among other settings, any setting where anxiolytics and analgesics are administered, when done so 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.
(c) "Accreditation agency" means a public or private organization that is approved to issue certificates of accreditation to outpatient settings by the board pursuant to Sections 1248.15 and 1248.4.
No association, corporation, firm, partnership, or person
shall operate, manage, conduct, or maintain an outpatient setting in
this state, unless the setting is one of the following:
(a) An ambulatory surgical center that is certified to participate in the Medicare program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act.
(b) Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1601 of Title 25 of the United States Code, and located on land recognized as tribal land by the federal government.
(c) Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies.
(d) Any primary care clinic licensed under subdivision (a) and any surgical clinic licensed under subdivision (b) of Section 1204.
(e) Any health facility licensed as a general acute care hospital under Chapter 2 (commencing with Section 1250).
(f) Any outpatient setting to the extent that it is used by a dentist or physician and surgeon in compliance with Article 2.7 (commencing with Section 1646) or Article 2.8 (commencing with Section 1647) of Chapter 4 of Division 2 of the Business and Professions Code.
(g) An outpatient setting accredited by an accreditation agency approved by the division pursuant to this chapter.
(h) A setting, including, but not limited to, a mobile van, in which equipment is used to treat patients admitted to a facility described in subdivision (a), (d), or (e), and in which the procedures performed are staffed by the medical staff of, or other healthcare practitioners with clinical privileges at, the facility and are subject to the peer review process of the facility but which setting is not a part of a facility described in subdivision (a), (d), or (e). Nothing in this section shall relieve an association, corporation, firm, partnership, or person from complying with all other provisions of law that are otherwise applicable.
(a) An ambulatory surgical center that is certified to participate in the Medicare program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act.
(b) Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1601 of Title 25 of the United States Code, and located on land recognized as tribal land by the federal government.
(c) Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies.
(d) Any primary care clinic licensed under subdivision (a) and any surgical clinic licensed under subdivision (b) of Section 1204.
(e) Any health facility licensed as a general acute care hospital under Chapter 2 (commencing with Section 1250).
(f) Any outpatient setting to the extent that it is used by a dentist or physician and surgeon in compliance with Article 2.7 (commencing with Section 1646) or Article 2.8 (commencing with Section 1647) of Chapter 4 of Division 2 of the Business and Professions Code.
(g) An outpatient setting accredited by an accreditation agency approved by the division pursuant to this chapter.
(h) A setting, including, but not limited to, a mobile van, in which equipment is used to treat patients admitted to a facility described in subdivision (a), (d), or (e), and in which the procedures performed are staffed by the medical staff of, or other healthcare practitioners with clinical privileges at, the facility and are subject to the peer review process of the facility but which setting is not a part of a facility described in subdivision (a), (d), or (e). Nothing in this section shall relieve an association, corporation, firm, partnership, or person from complying with all other provisions of law that are otherwise applicable.
(a) The board shall adopt standards for accreditation and,
in approving accreditation agencies to perform accreditation of
outpatient settings, shall ensure that the certification program
shall, at a minimum, include standards for the following aspects of
the settings' operations:
(1) Outpatient setting allied health staff shall be licensed or certified to the extent required by state or federal law.
(2) (A) Outpatient settings shall have a system for facility safety and emergency training requirements.
(B) There shall be onsite equipment, medication, and trained personnel to facilitate handling of services sought or provided and to facilitate handling of any medical emergency that may arise in connection with services sought or provided.
(C) In order for procedures to be performed in an outpatient setting as defined in Section 1248, the outpatient setting shall do one of the following:
(i) Have a written transfer agreement with a local accredited or licensed acute care hospital, approved by the facility's medical staff.
(ii) 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.
(iii) 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.
(D) The outpatient setting shall submit for approval by an accreditation agency at the time of accreditation 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:
(i) Notify the individual designated by the patient to be notified in case of an emergency.
(ii) Ensure that the mode of transfer is consistent with the patient's medical condition.
(iii) Ensure that all relevant clinical information is documented and accompanies the patient at the time of transfer.
(iv) Continue to provide appropriate care to the patient until the transfer is effectuated.
(E) All physicians and surgeons transferring patients from an outpatient setting shall agree to cooperate with the 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.
(3) The outpatient setting shall permit surgery by a dentist acting within his or her scope of practice under Chapter 4 (commencing with Section 1600) of Division 2 of the Business and Professions Code or physician and surgeon, osteopathic physician and surgeon, or podiatrist acting within his or her scope of practice under Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code or the Osteopathic Initiative Act. The outpatient setting may, in its discretion, permit anesthesia service by a certified registered nurse anesthetist acting within his or her scope of practice under Article 7 (commencing with Section 2825) of Chapter 6 of Division 2 of the Business and Professions Code.
(4) Outpatient settings shall have a system for maintaining clinical records.
(5) Outpatient settings shall have a system for patient care and monitoring procedures.
(6) (A) Outpatient settings shall have a system for quality assessment and improvement.
(B) (i) Members of the medical staff and other practitioners who are granted clinical privileges shall be professionally qualified and appropriately credentialed for the performance of privileges granted. The outpatient setting shall grant privileges in accordance with recommendations from qualified health professionals, and credentialing standards established by the outpatient setting.
(ii) 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.
(C) 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.
(7) Outpatient settings regulated by this chapter that have multiple service locations shall have all of the sites inspected.
(8) Outpatient settings shall post the certificate of accreditation in a location readily visible to patients and staff.
(9) Outpatient settings shall post the name and telephone number of the accrediting agency with instructions on the submission of complaints in a location readily visible to patients and staff.
(10) Outpatient settings shall have a written discharge criteria.
(b) 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), as long as a patient is present who has not been discharged from supervised care. Transfer to an unlicensed setting of a patient who does not meet the discharge criteria adopted pursuant to paragraph (10) of subdivision (a) shall constitute unprofessional conduct.
(c) An accreditation agency may include additional standards in its determination to accredit outpatient settings if these are approved by the board to protect the public health and safety.
(d) 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, in accordance with credentialing standards established by the outpatient setting in compliance with this chapter. Privileges may not be arbitrarily restricted based on category of licensure.
(e) The board shall adopt standards that it deems necessary for outpatient settings that offer in vitro fertilization.
(f) 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.
(g) 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. For the purposes of this section, "conducting a reasonable investigation" means querying the Medical Board of California and the Osteopathic Medical Board of California to ascertain if either the outpatient setting has, or, if its owners are licensed physicians and surgeons, if those physicians and surgeons have, been subject to an adverse accreditation decision.
(1) Outpatient setting allied health staff shall be licensed or certified to the extent required by state or federal law.
(2) (A) Outpatient settings shall have a system for facility safety and emergency training requirements.
(B) There shall be onsite equipment, medication, and trained personnel to facilitate handling of services sought or provided and to facilitate handling of any medical emergency that may arise in connection with services sought or provided.
(C) In order for procedures to be performed in an outpatient setting as defined in Section 1248, the outpatient setting shall do one of the following:
(i) Have a written transfer agreement with a local accredited or licensed acute care hospital, approved by the facility's medical staff.
(ii) 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.
(iii) 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.
(D) The outpatient setting shall submit for approval by an accreditation agency at the time of accreditation 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:
(i) Notify the individual designated by the patient to be notified in case of an emergency.
(ii) Ensure that the mode of transfer is consistent with the patient's medical condition.
(iii) Ensure that all relevant clinical information is documented and accompanies the patient at the time of transfer.
(iv) Continue to provide appropriate care to the patient until the transfer is effectuated.
(E) All physicians and surgeons transferring patients from an outpatient setting shall agree to cooperate with the 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.
(3) The outpatient setting shall permit surgery by a dentist acting within his or her scope of practice under Chapter 4 (commencing with Section 1600) of Division 2 of the Business and Professions Code or physician and surgeon, osteopathic physician and surgeon, or podiatrist acting within his or her scope of practice under Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code or the Osteopathic Initiative Act. The outpatient setting may, in its discretion, permit anesthesia service by a certified registered nurse anesthetist acting within his or her scope of practice under Article 7 (commencing with Section 2825) of Chapter 6 of Division 2 of the Business and Professions Code.
(4) Outpatient settings shall have a system for maintaining clinical records.
(5) Outpatient settings shall have a system for patient care and monitoring procedures.
(6) (A) Outpatient settings shall have a system for quality assessment and improvement.
(B) (i) Members of the medical staff and other practitioners who are granted clinical privileges shall be professionally qualified and appropriately credentialed for the performance of privileges granted. The outpatient setting shall grant privileges in accordance with recommendations from qualified health professionals, and credentialing standards established by the outpatient setting.
(ii) 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.
(C) 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.
(7) Outpatient settings regulated by this chapter that have multiple service locations shall have all of the sites inspected.
(8) Outpatient settings shall post the certificate of accreditation in a location readily visible to patients and staff.
(9) Outpatient settings shall post the name and telephone number of the accrediting agency with instructions on the submission of complaints in a location readily visible to patients and staff.
(10) Outpatient settings shall have a written discharge criteria.
(b) 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), as long as a patient is present who has not been discharged from supervised care. Transfer to an unlicensed setting of a patient who does not meet the discharge criteria adopted pursuant to paragraph (10) of subdivision (a) shall constitute unprofessional conduct.
(c) An accreditation agency may include additional standards in its determination to accredit outpatient settings if these are approved by the board to protect the public health and safety.
(d) 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, in accordance with credentialing standards established by the outpatient setting in compliance with this chapter. Privileges may not be arbitrarily restricted based on category of licensure.
(e) The board shall adopt standards that it deems necessary for outpatient settings that offer in vitro fertilization.
(f) 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.
(g) 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. For the purposes of this section, "conducting a reasonable investigation" means querying the Medical Board of California and the Osteopathic Medical Board of California to ascertain if either the outpatient setting has, or, if its owners are licensed physicians and surgeons, if those physicians and surgeons have, been subject to an adverse accreditation decision.
(a) Any outpatient setting may apply to an accreditation
agency for a certificate of accreditation. Accreditation shall be
issued by the accreditation agency solely on the basis of compliance
with its standards as approved by the board under this chapter.
(b) The board shall obtain and maintain a list of accredited outpatient settings from the information provided by the accreditation agencies approved by the board, and shall notify the public, by placing the information on its Internet Web site, whether an outpatient setting is accredited or the setting's accreditation has been revoked, suspended, or placed on probation, or the setting has received a reprimand by the accreditation agency.
(c) The list of outpatient settings shall include all of the following:
(1) Name, address, and telephone number of any owners, and their medical license numbers.
(2) Name and address of the facility.
(3) The name and telephone number of the accreditation agency.
(4) The effective and expiration dates of the accreditation.
(d) Accrediting agencies approved by the board shall notify the board and update the board on all outpatient settings that are accredited.
(b) The board shall obtain and maintain a list of accredited outpatient settings from the information provided by the accreditation agencies approved by the board, and shall notify the public, by placing the information on its Internet Web site, whether an outpatient setting is accredited or the setting's accreditation has been revoked, suspended, or placed on probation, or the setting has received a reprimand by the accreditation agency.
(c) The list of outpatient settings shall include all of the following:
(1) Name, address, and telephone number of any owners, and their medical license numbers.
(2) Name and address of the facility.
(3) The name and telephone number of the accreditation agency.
(4) The effective and expiration dates of the accreditation.
(d) Accrediting agencies approved by the board shall notify the board and update the board on all outpatient settings that are accredited.
If an outpatient setting does not meet the standards
approved by the board, accreditation shall be denied by the
accreditation agency, which shall provide the outpatient setting
notification of the reasons for the denial. An outpatient setting may
reapply for accreditation at any time after receiving notification
of the denial. The accreditation agency shall report within three
business days to the board if the outpatient setting's certificate
for accreditation has been denied.
(a) Certificates of accreditation issued to outpatient
settings by an accreditation agency shall be valid for not more than
three years.
(b) The outpatient setting shall notify the accreditation agency within 30 days of any significant change in ownership, including, but not limited to, a merger, change in majority interest, consolidation, name change, change in scope of services, additional services, or change in locations.
(c) Except for disclosures to the division or to the Division of Medical Quality under this chapter, an accreditation agency shall not disclose information obtained in the performance of accreditation activities under this chapter that individually identifies patients, individual medical practitioners, or outpatient settings. Neither the proceedings nor the records of an accreditation agency or the proceedings and records of an outpatient setting related to performance of quality assurance or accreditation activities under this chapter shall be subject to discovery, nor shall the records or proceedings be admissible in a court of law. The prohibition relating to discovery and admissibility of records and proceedings does not apply to any outpatient setting requesting accreditation in the event that denial or revocation of that outpatient setting's accreditation is being contested. Nothing in this section shall prohibit the accreditation agency from making discretionary disclosures of information to an outpatient setting pertaining to the accreditation of that outpatient setting.
(b) The outpatient setting shall notify the accreditation agency within 30 days of any significant change in ownership, including, but not limited to, a merger, change in majority interest, consolidation, name change, change in scope of services, additional services, or change in locations.
(c) Except for disclosures to the division or to the Division of Medical Quality under this chapter, an accreditation agency shall not disclose information obtained in the performance of accreditation activities under this chapter that individually identifies patients, individual medical practitioners, or outpatient settings. Neither the proceedings nor the records of an accreditation agency or the proceedings and records of an outpatient setting related to performance of quality assurance or accreditation activities under this chapter shall be subject to discovery, nor shall the records or proceedings be admissible in a court of law. The prohibition relating to discovery and admissibility of records and proceedings does not apply to any outpatient setting requesting accreditation in the event that denial or revocation of that outpatient setting's accreditation is being contested. Nothing in this section shall prohibit the accreditation agency from making discretionary disclosures of information to an outpatient setting pertaining to the accreditation of that outpatient setting.
(a) Every outpatient setting that is accredited shall be
inspected by the accreditation agency and may also be inspected by
the Medical Board of California. The Medical Board of California
shall ensure that accreditation agencies inspect outpatient settings.
(b) Unless otherwise specified, the following requirements apply to inspections described in subdivision (a).
(1) The frequency of inspection shall depend upon the type and complexity of the outpatient setting to be inspected.
(2) Inspections shall be conducted no less often than once every three years by the accreditation agency and as often as necessary by the Medical Board of California to ensure the quality of care provided. After the initial inspection for accreditation, subsequent inspections may be unannounced. For unannounced routine inspections, the accreditation agency shall notify the outpatient setting that the inspection will occur within 60 days.
(3) The Medical Board of California or the accreditation agency may enter and inspect any outpatient setting that is accredited by an accreditation agency at any reasonable time to ensure compliance with, or investigate an alleged violation of, any standard of the accreditation agency or any provision of this chapter.
(c) If an accreditation agency determines, as a result of its inspection, that an outpatient setting is not in compliance with the standards under which it was approved, the accreditation agency may do any of the following:
(1) Require correction of any identified deficiencies within a set timeframe. Failure to comply shall result in the accrediting agency issuing a reprimand or suspending or revoking the outpatient setting' s accreditation.
(2) Issue a reprimand.
(3) Place the outpatient setting on probation, during which time the setting shall successfully institute and complete a plan of correction, approved by the board or the accreditation agency, to correct the deficiencies.
(4) Suspend or revoke the outpatient setting's certification of accreditation.
(d) (1) Except as is otherwise provided in this subdivision, before suspending or revoking a certificate of accreditation under this chapter, the accreditation agency shall provide the outpatient setting with notice of any deficiencies and the outpatient setting shall agree with the accreditation agency on a plan of correction that shall give the outpatient setting reasonable time to supply information demonstrating compliance with the standards of the accreditation agency in compliance with this chapter, as well as the opportunity for a hearing on the matter upon the request of the outpatient setting. During the allotted time to correct the deficiencies, the plan of correction, which includes the deficiencies, shall be conspicuously posted by the outpatient setting in a location accessible to public view. Within 10 days after the adoption of the plan of correction, the accrediting agency shall send a list of deficiencies and the corrective action to be taken to the board and to the California State Board of Pharmacy if an outpatient setting is licensed pursuant to Article 14 (commencing with Section 4190) of Chapter 9 of Division 2 of the Business and Professions Code. The accreditation agency may immediately suspend the certificate of accreditation before providing notice and an opportunity to be heard, but only when failure to take the action may result in imminent danger to the health of an individual. In such cases, the accreditation agency shall provide subsequent notice and an opportunity to be heard.
(2) If an outpatient setting does not comply with a corrective action within a timeframe specified by the accrediting agency, the accrediting agency shall issue a reprimand, and may either place the outpatient setting on probation or suspend or revoke the accreditation of the outpatient setting, and shall notify the board of its action. This section shall not be deemed to prohibit an outpatient setting that is unable to correct the deficiencies, as specified in the plan of correction, for reasons beyond its control, from voluntarily surrendering its accreditation prior to initiation of any suspension or revocation proceeding.
(e) The accreditation agency shall, within 24 hours, report to the board if the outpatient setting has been issued a reprimand or if the outpatient setting's certification of accreditation has been suspended or revoked or if the outpatient setting has been placed on probation. If an outpatient setting has been issued a license by the California State Board of Pharmacy pursuant to Article 14 (commencing with Section 4190) of Chapter 9 of Division 2 of the Business and Professions Code, the accreditation agency shall also send this report to the California State Board of Pharmacy within 24 hours.
(f) The accreditation agency, upon receipt of a complaint from the board that an outpatient setting poses an immediate risk to public safety, shall inspect the outpatient setting and report its findings of inspection to the board within five business days. If an accreditation agency receives any other complaint from the board, it shall investigate the outpatient setting and report its findings of investigation to the board within 30 days.
(g) Reports on the results of any inspection shall be kept on file with the board and the accreditation agency along with the plan of correction and the comments of the outpatient setting. The inspection report may include a recommendation for reinspection. All final inspection reports, which include the lists of deficiencies, plans of correction or requirements for improvements and correction, and corrective action completed, shall be public records open to public inspection.
(h) If one accrediting agency denies accreditation, or revokes or suspends the accreditation of an outpatient setting, this action shall apply to all other accrediting agencies. An outpatient setting that is denied accreditation is permitted to reapply for accreditation with the same accrediting agency. The outpatient setting also may apply for accreditation from another accrediting agency, but only if it discloses the full accreditation report of the accrediting agency that denied accreditation. Any outpatient setting that has been denied accreditation shall disclose the accreditation report to any other accrediting agency to which it submits an application. The new accrediting agency shall ensure that all deficiencies have been corrected and conduct a new onsite inspection consistent with the standards specified in this chapter.
(i) If an outpatient setting's certification of accreditation has been suspended or revoked, or if the accreditation has been denied, the accreditation agency shall do all of the following:
(1) Notify the board of the action.
(2) Send a notification letter to the outpatient setting of the action. The notification letter shall state that the setting is no longer allowed to perform procedures that require outpatient setting accreditation.
(3) Require the outpatient setting to remove its accreditation certification and to post the notification letter in a conspicuous location, accessible to public view.
(j) The board may take any appropriate action it deems necessary pursuant to Section 1248.7 if an outpatient setting's certification of accreditation has been suspended or revoked, or if accreditation has been denied.
(b) Unless otherwise specified, the following requirements apply to inspections described in subdivision (a).
(1) The frequency of inspection shall depend upon the type and complexity of the outpatient setting to be inspected.
(2) Inspections shall be conducted no less often than once every three years by the accreditation agency and as often as necessary by the Medical Board of California to ensure the quality of care provided. After the initial inspection for accreditation, subsequent inspections may be unannounced. For unannounced routine inspections, the accreditation agency shall notify the outpatient setting that the inspection will occur within 60 days.
(3) The Medical Board of California or the accreditation agency may enter and inspect any outpatient setting that is accredited by an accreditation agency at any reasonable time to ensure compliance with, or investigate an alleged violation of, any standard of the accreditation agency or any provision of this chapter.
(c) If an accreditation agency determines, as a result of its inspection, that an outpatient setting is not in compliance with the standards under which it was approved, the accreditation agency may do any of the following:
(1) Require correction of any identified deficiencies within a set timeframe. Failure to comply shall result in the accrediting agency issuing a reprimand or suspending or revoking the outpatient setting' s accreditation.
(2) Issue a reprimand.
(3) Place the outpatient setting on probation, during which time the setting shall successfully institute and complete a plan of correction, approved by the board or the accreditation agency, to correct the deficiencies.
(4) Suspend or revoke the outpatient setting's certification of accreditation.
(d) (1) Except as is otherwise provided in this subdivision, before suspending or revoking a certificate of accreditation under this chapter, the accreditation agency shall provide the outpatient setting with notice of any deficiencies and the outpatient setting shall agree with the accreditation agency on a plan of correction that shall give the outpatient setting reasonable time to supply information demonstrating compliance with the standards of the accreditation agency in compliance with this chapter, as well as the opportunity for a hearing on the matter upon the request of the outpatient setting. During the allotted time to correct the deficiencies, the plan of correction, which includes the deficiencies, shall be conspicuously posted by the outpatient setting in a location accessible to public view. Within 10 days after the adoption of the plan of correction, the accrediting agency shall send a list of deficiencies and the corrective action to be taken to the board and to the California State Board of Pharmacy if an outpatient setting is licensed pursuant to Article 14 (commencing with Section 4190) of Chapter 9 of Division 2 of the Business and Professions Code. The accreditation agency may immediately suspend the certificate of accreditation before providing notice and an opportunity to be heard, but only when failure to take the action may result in imminent danger to the health of an individual. In such cases, the accreditation agency shall provide subsequent notice and an opportunity to be heard.
(2) If an outpatient setting does not comply with a corrective action within a timeframe specified by the accrediting agency, the accrediting agency shall issue a reprimand, and may either place the outpatient setting on probation or suspend or revoke the accreditation of the outpatient setting, and shall notify the board of its action. This section shall not be deemed to prohibit an outpatient setting that is unable to correct the deficiencies, as specified in the plan of correction, for reasons beyond its control, from voluntarily surrendering its accreditation prior to initiation of any suspension or revocation proceeding.
(e) The accreditation agency shall, within 24 hours, report to the board if the outpatient setting has been issued a reprimand or if the outpatient setting's certification of accreditation has been suspended or revoked or if the outpatient setting has been placed on probation. If an outpatient setting has been issued a license by the California State Board of Pharmacy pursuant to Article 14 (commencing with Section 4190) of Chapter 9 of Division 2 of the Business and Professions Code, the accreditation agency shall also send this report to the California State Board of Pharmacy within 24 hours.
(f) The accreditation agency, upon receipt of a complaint from the board that an outpatient setting poses an immediate risk to public safety, shall inspect the outpatient setting and report its findings of inspection to the board within five business days. If an accreditation agency receives any other complaint from the board, it shall investigate the outpatient setting and report its findings of investigation to the board within 30 days.
(g) Reports on the results of any inspection shall be kept on file with the board and the accreditation agency along with the plan of correction and the comments of the outpatient setting. The inspection report may include a recommendation for reinspection. All final inspection reports, which include the lists of deficiencies, plans of correction or requirements for improvements and correction, and corrective action completed, shall be public records open to public inspection.
(h) If one accrediting agency denies accreditation, or revokes or suspends the accreditation of an outpatient setting, this action shall apply to all other accrediting agencies. An outpatient setting that is denied accreditation is permitted to reapply for accreditation with the same accrediting agency. The outpatient setting also may apply for accreditation from another accrediting agency, but only if it discloses the full accreditation report of the accrediting agency that denied accreditation. Any outpatient setting that has been denied accreditation shall disclose the accreditation report to any other accrediting agency to which it submits an application. The new accrediting agency shall ensure that all deficiencies have been corrected and conduct a new onsite inspection consistent with the standards specified in this chapter.
(i) If an outpatient setting's certification of accreditation has been suspended or revoked, or if the accreditation has been denied, the accreditation agency shall do all of the following:
(1) Notify the board of the action.
(2) Send a notification letter to the outpatient setting of the action. The notification letter shall state that the setting is no longer allowed to perform procedures that require outpatient setting accreditation.
(3) Require the outpatient setting to remove its accreditation certification and to post the notification letter in a conspicuous location, accessible to public view.
(j) The board may take any appropriate action it deems necessary pursuant to Section 1248.7 if an outpatient setting's certification of accreditation has been suspended or revoked, or if accreditation has been denied.
(a) It is the intent of the Legislature that an
accreditation agency operating on or before January 1, 1995, or a
successor thereof, or an accreditation agency thereafter operating as
part of a joint program granted temporary certification as an
accreditation agency by the division, whether operating as part of a
joint program or independently, and meeting the standards set forth
in this chapter, as determined by the division, not be required to go
through the entire application process with the division. Therefore,
the division may grant a temporary certificate of approval to such
an accreditation agency. The temporary approval issued to an
accreditation agency under this subdivision shall expire on January
1, 1998. In order to continue its status as an accreditation agency,
an accreditation agency approved by the division under this
subdivision shall apply for renewal of approval by the division on or
before January 1, 1998, and shall establish that it is in compliance
with the standards set forth in this chapter and any regulations
adopted pursuant thereto.
(b) Each accreditation agency approved by the division shall, on and after January 1, 1995, promptly forward to the division a list of each outpatient setting to which it has granted a certificate of accreditation, as well as settings that have lost accreditation or were denied accreditation.
(c) The division shall approve an accreditation agency that applies for approval on a form prescribed by the division, accompanied by payment of the fee prescribed by this chapter and evidence that the accreditation agency meets the following criteria:
(1) Includes within its accreditation program, at a minimum, the standards for accreditation of outpatient settings approved by the division as well as standards for patient care and safety at the setting.
(2) Submits its current accreditation standards to the division every three years, or upon request for continuing approval by the division.
(3) Maintains internal quality management programs to ensure quality of the accreditation process.
(4) Has a process by which accreditation standards can be reviewed and revised no less than every three years.
(5) Maintains an available pool of allied health care practitioners to serve on accreditation review teams as appropriate.
(6) Has accreditation review teams that shall do all of the following:
(A) Consist of at least one physician and surgeon who practices in an outpatient setting; any other members shall be practicing actively in these settings.
(B) Participate in formal educational training programs provided by the accreditation agency in evaluation of the certification standards at least every three years.
(7) The accreditation agency shall demonstrate that professional members of its review team have experience in conducting review activities of freestanding outpatient settings.
(8) Standards for accreditation shall be developed with the input of the medical community and the ambulatory surgery industry.
(9) Accreditation reviewers shall be credentialed and screened by the accreditation agency.
(10) The accreditation agency shall not have an ownership interest in nor be involved in the operation of a freestanding outpatient setting, nor in the delivery of health care services to patients.
(d) Accreditation agencies approved by the division shall forward to the division copies of all certificates of accreditation and shall notify the division promptly whenever the agency denies or revokes a certificate of accreditation.
(e) A certification of an accreditation agency by the division shall expire at midnight on the last day of a three-year term if not renewed. The division shall establish by regulation the procedure for renewal. To renew an unexpired approval, the accreditation agency shall, on or before the date upon which the certification would otherwise expire, apply for renewal on a form, and pay the renewal fee, as prescribed by the division.
(b) Each accreditation agency approved by the division shall, on and after January 1, 1995, promptly forward to the division a list of each outpatient setting to which it has granted a certificate of accreditation, as well as settings that have lost accreditation or were denied accreditation.
(c) The division shall approve an accreditation agency that applies for approval on a form prescribed by the division, accompanied by payment of the fee prescribed by this chapter and evidence that the accreditation agency meets the following criteria:
(1) Includes within its accreditation program, at a minimum, the standards for accreditation of outpatient settings approved by the division as well as standards for patient care and safety at the setting.
(2) Submits its current accreditation standards to the division every three years, or upon request for continuing approval by the division.
(3) Maintains internal quality management programs to ensure quality of the accreditation process.
(4) Has a process by which accreditation standards can be reviewed and revised no less than every three years.
(5) Maintains an available pool of allied health care practitioners to serve on accreditation review teams as appropriate.
(6) Has accreditation review teams that shall do all of the following:
(A) Consist of at least one physician and surgeon who practices in an outpatient setting; any other members shall be practicing actively in these settings.
(B) Participate in formal educational training programs provided by the accreditation agency in evaluation of the certification standards at least every three years.
(7) The accreditation agency shall demonstrate that professional members of its review team have experience in conducting review activities of freestanding outpatient settings.
(8) Standards for accreditation shall be developed with the input of the medical community and the ambulatory surgery industry.
(9) Accreditation reviewers shall be credentialed and screened by the accreditation agency.
(10) The accreditation agency shall not have an ownership interest in nor be involved in the operation of a freestanding outpatient setting, nor in the delivery of health care services to patients.
(d) Accreditation agencies approved by the division shall forward to the division copies of all certificates of accreditation and shall notify the division promptly whenever the agency denies or revokes a certificate of accreditation.
(e) A certification of an accreditation agency by the division shall expire at midnight on the last day of a three-year term if not renewed. The division shall establish by regulation the procedure for renewal. To renew an unexpired approval, the accreditation agency shall, on or before the date upon which the certification would otherwise expire, apply for renewal on a form, and pay the renewal fee, as prescribed by the division.
The board shall evaluate the performance of an approved
accreditation agency no less than every three years, or in response
to complaints against an agency, or complaints against one or more
outpatient settings accreditation by an agency that indicates
noncompliance by the agency with the standards approved by the board.
(a) If the accreditation agency is not meeting the
criteria set by the division, the division may terminate approval of
the agency.
(b) Before terminating approval of an accreditation agency, the division shall provide the accreditation agency with notice of any deficiencies and reasonable time to supply information demonstrating compliance with the requirements of this chapter, as well as the opportunity for a hearing on the matter in compliance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.
(c) (1) If approval of the accreditation agency is terminated by the division, outpatient settings accredited by that agency shall be notified by the division and, except as provided in paragraph (2), shall be authorized to continue to operate for a period of 12 months in order to seek accreditation through an approved accreditation agency, unless the time is extended by the division for good cause.
(2) The division may require that an outpatient setting, that has been accredited by an accreditation agency whose approval has been terminated by the division, cease operations immediately in the event that the division is in possession of information indicating that continued operation poses an imminent risk of harm to the health of an individual. In such cases, the division shall provide the outpatient setting with notice of its action, the reason underlying it, and a subsequent opportunity for a hearing on the matter. An outpatient setting that is ordered to cease operations under this paragraph may reapply for a certificate of accreditation after six months and shall notify the division promptly of its reapplication.
(b) Before terminating approval of an accreditation agency, the division shall provide the accreditation agency with notice of any deficiencies and reasonable time to supply information demonstrating compliance with the requirements of this chapter, as well as the opportunity for a hearing on the matter in compliance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.
(c) (1) If approval of the accreditation agency is terminated by the division, outpatient settings accredited by that agency shall be notified by the division and, except as provided in paragraph (2), shall be authorized to continue to operate for a period of 12 months in order to seek accreditation through an approved accreditation agency, unless the time is extended by the division for good cause.
(2) The division may require that an outpatient setting, that has been accredited by an accreditation agency whose approval has been terminated by the division, cease operations immediately in the event that the division is in possession of information indicating that continued operation poses an imminent risk of harm to the health of an individual. In such cases, the division shall provide the outpatient setting with notice of its action, the reason underlying it, and a subsequent opportunity for a hearing on the matter. An outpatient setting that is ordered to cease operations under this paragraph may reapply for a certificate of accreditation after six months and shall notify the division promptly of its reapplication.
(a) The Division of Licensing shall establish by regulation
a reasonable fee for an application for approval as an accreditation
agency in an amount that is reasonably necessary to recover the cost
of implementing and administering this chapter, and not to exceed
five thousand dollars ($5,000). The division shall establish by
regulation a reasonable fee for a temporary certificate of approval,
as outlined in subdivision (a) of Section 1248.4, not to exceed two
thousand dollars ($2,000). The division shall also establish a
reasonable fee for renewal. The renewal fee shall be proportionate to
the number of outpatient settings accredited by the approved
accrediting body seeking renewal, and shall not exceed one hundred
dollars ($100) per outpatient setting accreditation reviewed.
(b) All fees paid to and received by the division or the Medical Board of California under this chapter shall be paid into the State Treasury and shall be credited to a special fund that is hereby created as the Outpatient Setting Fund of the Medical Board of California. Funds in the Outpatient Setting Fund of the Medical Board of California shall be expended by the board for the purpose of implementing and administering this chapter upon appropriation by the Legislature. No surplus in the fund shall be deposited in or transferred to the General Fund or any other fund.
(b) All fees paid to and received by the division or the Medical Board of California under this chapter shall be paid into the State Treasury and shall be credited to a special fund that is hereby created as the Outpatient Setting Fund of the Medical Board of California. Funds in the Outpatient Setting Fund of the Medical Board of California shall be expended by the board for the purpose of implementing and administering this chapter upon appropriation by the Legislature. No surplus in the fund shall be deposited in or transferred to the General Fund or any other fund.
It shall constitute unprofessional conduct for a physician
and surgeon to willfully and knowingly violate this chapter.
(a) The board shall investigate all complaints concerning a
violation of this chapter. With respect to any complaints relating
to a violation of Section 1248.1, or upon discovery that an
outpatient setting is not in compliance with Section 1248.1, the
board shall investigate and, where appropriate, the board, through or
in conjunction with the local district attorney, shall bring an
action to enjoin the outpatient setting's operation. The board or the
local district attorney may bring an action to enjoin a violation or
threatened violation of any other provision of this chapter in the
superior court in and for the county in which the violation occurred
or is about to occur. Any proceeding under this section shall conform
to the requirements of Chapter 3 (commencing with Section 525) of
Title 7 of Part 2 of the Code of Civil Procedure, except that the
Division of Medical Quality shall not be required to allege facts
necessary to show or tending to show lack of adequate remedy at law
or irreparable damage or loss.
(b) With respect to any and all actions brought pursuant to this section alleging an actual or threatened violation of any requirement of this chapter, the court shall, if it finds the allegations to be true, issue an order enjoining the person or facility from continuing the violation. For purposes of Section 1248.1, if an outpatient setting is operating without a certificate of accreditation, this shall be prima facie evidence that a violation of Section 1248.1 has occurred and additional proof shall not be necessary to enjoin the outpatient setting's operation.
(b) With respect to any and all actions brought pursuant to this section alleging an actual or threatened violation of any requirement of this chapter, the court shall, if it finds the allegations to be true, issue an order enjoining the person or facility from continuing the violation. For purposes of Section 1248.1, if an outpatient setting is operating without a certificate of accreditation, this shall be prima facie evidence that a violation of Section 1248.1 has occurred and additional proof shall not be necessary to enjoin the outpatient setting's operation.
(a) Except as may otherwise be provided in this section,
before the Division of Medical Quality may seek an injunction as
provided under Section 1248.7, the Division of Medical Quality shall
notify the outpatient setting of all deficiencies in its compliance
with this chapter, and any rules and regulations adopted pursuant to
this chapter, and the Division of Medical Quality and the outpatient
setting shall reach an agreement upon a plan of correction that shall
give the outpatient setting reasonable time to correct the
deficiencies. The Division of Medical Quality shall also inform the
outpatient setting that failure to reach an agreement or to correct
deficiencies may lead to corrective action by the Division of Medical
Quality, which may include imposition of fines under Section 1248.8.
If at the end of the allotted time the division and the outpatient
setting have failed to reach an agreement or the outpatient setting
has failed to correct the deficiencies, as revealed by inspection,
the Division of Medical Quality may take corrective action to
include, as appropriate, seeking an injunction under Section 1248.7,
revoking or requesting that the accreditation agency revoke
accreditation, or communicating with any agency that has oversight
authority over the outpatient setting, such as the Department of
Health Services or other appropriate licensing authority, to request
that the agency take corrective action against the outpatient
setting.
(b) For purposes of this section, and at the sole discretion of the Division of Medical Quality, any notifications, inspections, and corrective action plans of the Division of Medical Quality relating to outpatient settings that have been accredited by an accreditation agency may be performed or coordinated by the accreditation agency rather than by the Division of Medical Quality.
(c) If the Division of Medical Quality determines that an outpatient setting poses an immediate and substantial hazard to the health or safety of the patient, that may not reasonably be corrected through a plan of correction, the Division of Medical Quality may immediately institute injunction proceedings pursuant to Section 1248.7.
(b) For purposes of this section, and at the sole discretion of the Division of Medical Quality, any notifications, inspections, and corrective action plans of the Division of Medical Quality relating to outpatient settings that have been accredited by an accreditation agency may be performed or coordinated by the accreditation agency rather than by the Division of Medical Quality.
(c) If the Division of Medical Quality determines that an outpatient setting poses an immediate and substantial hazard to the health or safety of the patient, that may not reasonably be corrected through a plan of correction, the Division of Medical Quality may immediately institute injunction proceedings pursuant to Section 1248.7.
(a) Any person or entity that willfully violates this
chapter or any rule or regulation adopted under this chapter shall be
guilty of a misdemeanor and subject to a fine not to exceed one
thousand dollars ($1,000) per day of violation.
(b) In determining the punishment to be imposed under this section, the court shall consider all relevant facts, including, but not limited to, the following:
(1) Whether the violation exposed a patient or other individual to the risk of death or serious physical harm.
(2) Whether the violation had a direct or immediate relationship to health, safety, or security of a patient or other individual.
(3) Evidence, if any, of willfulness in the violation.
(4) The presence or absence of good faith efforts by the outpatient setting to prevent the violation.
(c) For purposes of this section, "willfully" or "willful" means that the person doing an act or omitting to do an act intends the act or omission, and knows the relevant circumstances connected with the act or omission.
(d) The district attorney of every county shall, upon application by the Division of Medical Quality or its authorized representative, institute and conduct the prosecution of any action or violation within the county of any provisions of this chapter.
(b) In determining the punishment to be imposed under this section, the court shall consider all relevant facts, including, but not limited to, the following:
(1) Whether the violation exposed a patient or other individual to the risk of death or serious physical harm.
(2) Whether the violation had a direct or immediate relationship to health, safety, or security of a patient or other individual.
(3) Evidence, if any, of willfulness in the violation.
(4) The presence or absence of good faith efforts by the outpatient setting to prevent the violation.
(c) For purposes of this section, "willfully" or "willful" means that the person doing an act or omitting to do an act intends the act or omission, and knows the relevant circumstances connected with the act or omission.
(d) The district attorney of every county shall, upon application by the Division of Medical Quality or its authorized representative, institute and conduct the prosecution of any action or violation within the county of any provisions of this chapter.
This chapter shall not preclude an approved accreditation
agency from adopting additional standards consistent with Section
1248.15, establishing procedures for the conduct of onsite
inspections, selecting onsite inspectors to perform accreditation
onsite inspections, or establishing and collecting reasonable fees
for the conduct of accreditation onsite inspections.
