Senate BillNo. 396


Introduced by Senator Hill

February 25, 2015


An act to amend Sections 805 and 805.5 of, and to add Section 2216.5 to, the Business and Professions Code, and to amend Sections 1204, 1248.15, 1248.3, and 1248.35 of the Health and Safety Code, relating to health and care facilities.

LEGISLATIVE COUNSEL’S DIGEST

SB 396, as introduced, Hill. Health and care facilities: outpatient settings and surgical clinics.

Existing law provides for the licensure and regulation of clinics by the State Department of Public Health. A violation of those provisions is a misdemeanor. Existing law provides that certain types of specialty clinics, including surgical clinics, as defined, are eligible for licensure.

This bill would clarify that a surgical clinic is eligible for licensure by the department regardless of physician or dentist ownership.

The Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California. Existing law provides that it is unprofessional conduct for a physician and surgeon to perform procedures in any outpatient setting except in compliance with specified provisions. Existing law prohibits an association, corporation, firm, partnership, or person from operating, managing, conducting, or maintaining an outpatient setting in the state unless the setting is one of the specified settings, which includes, among others, a surgical clinic licensed by the State Department of Public Health or an outpatient setting accredited by an accreditation agency approved by the Division of Licensing of the Medical Board of California.

Existing law provides that an outpatient setting that is accredited shall be inspected by the accreditation agency and may be inspected by the Medical Board of California. Existing law requires that the inspections be conducted no less often than once every 3 years by the accreditation agency and as often as necessary by the Medical Board of California to ensure quality of care provided. Existing law requires that certificates for accreditation issued to outpatient settings by an accreditation agency shall be valid for not more than 3 years.

This bill would require that all subsequent inspections after the initial inspection for accreditation be unannounced. This bill would require an outpatient setting accredited by the division to pay certain fees and to comply with certain data submission requirements. The bill would also instead require that an initial certificate of accreditation by an accreditation agency be valid for not more than 2 years and that a renewal certificate be valid for not more than 3 years.

Existing law requires members of the medical staff and other practitioners who are granted clinical privileges in an outpatient setting to be professionally qualified and appropriately credentialed for the performance of privileges granted and requires the outpatient setting to grant privileges in accordance with recommendations from qualified health professionals, and credentialing standards established by the outpatient setting.

This bill would additionally require that each physician and surgeon who performs procedures in an outpatient setting that requires the outpatient setting to be accredited be peer reviewed by California licensed physicians who are qualified by education experience to perform the same types of procedures. By expanding the scope of a crime, this bill would impose a state-mandated local program.

Existing law requires specified entities, including any health care service plan or medical care foundation, to request a report from the Medical Board of California, the Board of Psychology, the Osteopathic Medical Board of California, or the Dental Board of California, prior to granting or renewing staff privileges, to determine if a certain report has been made indicating that the applying physician and surgeon, psychologist, podiatrist, or dentist has been denied staff privileges, been removed from a medical staff, or had his or her staff privileges restricted.

This bill would also require an outpatient setting and a facility certified to participate in the federal Medicare program as an ambulatory surgical center to request that report. By expanding the scope of a crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

The people of the State of California do enact as follows:

P3    1

SECTION 1.  

Section 805 of the Business and Professions Code
2 is amended to read:

3

805.  

(a) As used in this section, the following terms have the
4following definitions:

5(1) (A) “Peer review” means both of the following:

6(i) A process in which a peer review body reviews the basic
7qualifications, staff privileges, employment, medical outcomes,
8or professional conduct of licentiates to make recommendations
9for quality improvement and education, if necessary, in order to
10do either or both of the following:

11(I) Determine whether a licentiate may practice or continue to
12practice in a health care facility, clinic, or other setting providing
13medical services, and, if so, to determine the parameters of that
14 practice.

15(II) Assess and improve the quality of care rendered in a health
16care facility, clinic, or other setting providing medical services.

17(ii) Any other activities of a peer review body as specified in
18subparagraph (B).

19(B) “Peer review body” includes:

20(i) A medical or professional staff of any health care facility or
21clinic licensed under Division 2 (commencing with Section 1200)
22of the Health and Safetybegin delete Code orend deletebegin insert Code,end insert of a facility certified to
23participate in the federal Medicare program as an ambulatory
24surgicalbegin delete center.end deletebegin insert center, or of an outpatient setting accredited
25pursuant to Section 1248.1 of the Health and Safety Code.end insert

26(ii) A health care service plan licensed under Chapter 2.2
27(commencing with Section 1340) of Division 2 of the Health and
28Safety Code or a disability insurer that contracts with licentiates
29to provide services at alternative rates of payment pursuant to
30Section 10133 of the Insurance Code.

P4    1(iii) Any medical, psychological, marriage and family therapy,
2social work, professional clinical counselor, dental, or podiatric
3professional society having as members at least 25 percent of the
4eligible licentiates in the area in which it functions (which must
5include at least one county), which is not organized for profit and
6which has been determined to be exempt from taxes pursuant to
7Section 23701 of the Revenue and Taxation Code.

8(iv) A committee organized by any entity consisting of or
9employing more than 25 licentiates of the same class that functions
10for the purpose of reviewing the quality of professional care
11provided by members or employees of that entity.

12(2) “Licentiate” means a physician and surgeon, doctor of
13podiatric medicine, clinical psychologist, marriage and family
14therapist, clinical social worker, professional clinical counselor,
15dentist, or physician assistant. “Licentiate” also includes a person
16authorized to practice medicine pursuant to Section 2113 or 2168.

17(3) “Agency” means the relevant state licensing agency having
18regulatory jurisdiction over the licentiates listed in paragraph (2).

19(4) “Staff privileges” means any arrangement under which a
20licentiate is allowed to practice in or provide care for patients in
21a health facility. Those arrangements shall include, but are not
22limited to, full staff privileges, active staff privileges, limited staff
23privileges, auxiliary staff privileges, provisional staff privileges,
24temporary staff privileges, courtesy staff privileges, locum tenens
25arrangements, and contractual arrangements to provide professional
26services, including, but not limited to, arrangements to provide
27outpatient services.

28(5) “Denial or termination of staff privileges, membership, or
29employment” includes failure or refusal to renew a contract or to
30renew, extend, or reestablish any staff privileges, if the action is
31based on medical disciplinary cause or reason.

32(6) “Medical disciplinary cause or reason” means that aspect
33of a licentiate’s competence or professional conduct that is
34reasonably likely to be detrimental to patient safety or to the
35delivery of patient care.

36(7) “805 report” means the written report required under
37subdivision (b).

38(b) The chief of staff of a medical or professional staff or other
39chief executive officer, medical director, or administrator of any
40peer review body and the chief executive officer or administrator
P5    1of any licensed health care facility or clinic shall file an 805 report
2with the relevant agency within 15 days after the effective date on
3which any of the following occur as a result of an action of a peer
4review body:

5(1) A licentiate’s application for staff privileges or membership
6is denied or rejected for a medical disciplinary cause or reason.

7(2) A licentiate’s membership, staff privileges, or employment
8is terminated or revoked for a medical disciplinary cause or reason.

9(3) Restrictions are imposed, or voluntarily accepted, on staff
10privileges, membership, or employment for a cumulative total of
1130 days or more for any 12-month period, for a medical disciplinary
12cause or reason.

13(c) If a licentiate takes any action listed in paragraph (1), (2),
14or (3) after receiving notice of a pending investigation initiated
15for a medical disciplinary cause or reason or after receiving notice
16that his or her application for membership or staff privileges is
17denied or will be denied for a medical disciplinary cause or reason,
18the chief of staff of a medical or professional staff or other chief
19executive officer, medical director, or administrator of any peer
20review body and the chief executive officer or administrator of
21any licensed health care facility or clinic where the licentiate is
22employed or has staff privileges or membership or where the
23licentiate applied for staff privileges or membership, or sought the
24renewal thereof, shall file an 805 report with the relevant agency
25within 15 days after the licentiate takes the action.

26(1) Resigns or takes a leave of absence from membership, staff
27privileges, or employment.

28(2) Withdraws or abandons his or her application for staff
29privileges or membership.

30(3) Withdraws or abandons his or her request for renewal of
31staff privileges or membership.

32(d) For purposes of filing an 805 report, the signature of at least
33one of the individuals indicated in subdivision (b) or (c) on the
34completed form shall constitute compliance with the requirement
35to file the report.

36(e) An 805 report shall also be filed within 15 days following
37the imposition of summary suspension of staff privileges,
38membership, or employment, if the summary suspension remains
39in effect for a period in excess of 14 days.

P6    1(f) A copy of the 805 report, and a notice advising the licentiate
2of his or her right to submit additional statements or other
3information, electronically or otherwise, pursuant to Section 800,
4shall be sent by the peer review body to the licentiate named in
5the report. The notice shall also advise the licentiate that
6information submitted electronically will be publicly disclosed to
7those who request the information.

8The information to be reported in an 805 report shall include the
9name and license number of the licentiate involved, a description
10of the facts and circumstances of the medical disciplinary cause
11or reason, and any other relevant information deemed appropriate
12by the reporter.

13A supplemental report shall also be made within 30 days
14following the date the licentiate is deemed to have satisfied any
15terms, conditions, or sanctions imposed as disciplinary action by
16the reporting peer review body. In performing its dissemination
17functions required by Section 805.5, the agency shall include a
18copy of a supplemental report, if any, whenever it furnishes a copy
19of the original 805 report.

20If another peer review body is required to file an 805 report, a
21health care service plan is not required to file a separate report
22with respect to action attributable to the same medical disciplinary
23cause or reason. If the Medical Board of California or a licensing
24agency of another state revokes or suspends, without a stay, the
25license of a physician and surgeon, a peer review body is not
26required to file an 805 report when it takes an action as a result of
27the revocation or suspension.

28(g) The reporting required by this section shall not act as a
29waiver of confidentiality of medical records and committee reports.
30The information reported or disclosed shall be kept confidential
31except as provided in subdivision (c) of Section 800 and Sections
32803.1 and 2027, provided that a copy of the report containing the
33information required by this section may be disclosed as required
34by Section 805.5 with respect to reports received on or after
35January 1, 1976.

36(h) The Medical Board of California, the Osteopathic Medical
37Board of California, and the Dental Board of California shall
38disclose reports as required by Section 805.5.

39(i) An 805 report shall be maintained electronically by an agency
40for dissemination purposes for a period of three years after receipt.

P7    1(j) No person shall incur any civil or criminal liability as the
2result of making any report required by this section.

3(k) A willful failure to file an 805 report by any person who is
4designated or otherwise required by law to file an 805 report is
5punishable by a fine not to exceed one hundred thousand dollars
6($100,000) per violation. The fine may be imposed in any civil or
7administrative action or proceeding brought by or on behalf of any
8agency having regulatory jurisdiction over the person regarding
9whom the report was or should have been filed. If the person who
10is designated or otherwise required to file an 805 report is a
11licensed physician and surgeon, the action or proceeding shall be
12brought by the Medical Board of California. The fine shall be paid
13to that agency but not expended until appropriated by the
14Legislature. A violation of this subdivision may constitute
15unprofessional conduct by the licentiate. A person who is alleged
16to have violated this subdivision may assert any defense available
17at law. As used in this subdivision, “willful” means a voluntary
18and intentional violation of a known legal duty.

19(l) Except as otherwise provided in subdivision (k), any failure
20by the administrator of any peer review body, the chief executive
21officer or administrator of any health care facility, or any person
22who is designated or otherwise required by law to file an 805
23report, shall be punishable by a fine that under no circumstances
24shall exceed fifty thousand dollars ($50,000) per violation. The
25fine may be imposed in any civil or administrative action or
26proceeding brought by or on behalf of any agency having
27regulatory jurisdiction over the person regarding whom the report
28was or should have been filed. If the person who is designated or
29otherwise required to file an 805 report is a licensed physician and
30surgeon, the action or proceeding shall be brought by the Medical
31Board of California. The fine shall be paid to that agency but not
32expended until appropriated by the Legislature. The amount of the
33fine imposed, not exceeding fifty thousand dollars ($50,000) per
34violation, shall be proportional to the severity of the failure to
35report and shall differ based upon written findings, including
36whether the failure to file caused harm to a patient or created a
37risk to patient safety; whether the administrator of any peer review
38body, the chief executive officer or administrator of any health
39care facility, or any person who is designated or otherwise required
40by law to file an 805 report exercised due diligence despite the
P8    1failure to file or whether they knew or should have known that an
2805 report would not be filed; and whether there has been a prior
3failure to file an 805 report. The amount of the fine imposed may
4also differ based on whether a health care facility is a small or
5rural hospital as defined in Section 124840 of the Health and Safety
6Code.

7(m) A health care service plan licensed under Chapter 2.2
8(commencing with Section 1340) of Division 2 of the Health and
9Safety Code or a disability insurer that negotiates and enters into
10a contract with licentiates to provide services at alternative rates
11of payment pursuant to Section 10133 of the Insurance Code, when
12determining participation with the plan or insurer, shall evaluate,
13on a case-by-case basis, licentiates who are the subject of an 805
14report, and not automatically exclude or deselect these licentiates.

15

SEC. 2.  

Section 805.5 of the Business and Professions Code
16 is amended to read:

17

805.5.  

(a) Prior to granting or renewing staff privileges for
18any physician and surgeon, psychologist, podiatrist, or dentist, any
19health facility licensed pursuant to Division 2 (commencing with
20Section 1200) of the Health and Safety Code,begin delete orend delete any health care
21service plan or medical care foundation,begin delete orend delete the medical staff of the
22begin delete institutionend deletebegin insert institution, end insertbegin inserta facility certified to participate in the federal
23 Medicare program as an ambulatory surgical center, or end insert
begin insertan
24outpatient setting accredited pursuant to Section 1248.1 of the
25Health and Safety Codeend insert
shall request a report from the Medical
26Board of California, the Board of Psychology, the Osteopathic
27Medical Board of California, or the Dental Board of California to
28determine if any report has been made pursuant to Section 805
29indicating that the applying physician and surgeon, psychologist,
30podiatrist, or dentist has been denied staff privileges, been removed
31from a medical staff, or had his or her staff privileges restricted as
32provided in Section 805. The request shall include the name and
33California license number of the physician and surgeon,
34psychologist, podiatrist, or dentist. Furnishing of a copy of the 805
35report shall not cause the 805 report to be a public record.

36(b) Upon a request made by, or on behalf of, an institution
37described in subdivision (a) or its medical staff the board shall
38furnish a copy of any report made pursuant to Section 805 as well
39as any additional exculpatory or explanatory information submitted
40electronically to the board by the licensee pursuant to subdivision
P9    1(f) of that section. However, the board shall not send a copy of a
2report (1) if the denial, removal, or restriction was imposed solely
3because of the failure to complete medical records, (2) if the board
4has found the information reported is without merit, (3) if a court
5finds, in a final judgment, that the peer review, as defined in
6Section 805, resulting in the report was conducted in bad faith and
7the licensee who is the subject of the report notifies the board of
8that finding, or (4) if a period of three years has elapsed since the
9report was submitted. This three-year period shall be tolled during
10any period the licentiate has obtained a judicial order precluding
11 disclosure of the report, unless the board is finally and permanently
12precluded by judicial order from disclosing the report. If a request
13is received by the board while the board is subject to a judicial
14order limiting or precluding disclosure, the board shall provide a
15disclosure to any qualified requesting party as soon as practicable
16after the judicial order is no longer in force.

17If the board fails to advise the institution within 30 working days
18following its request for a report required by this section, the
19institution may grant or renew staff privileges for the physician
20and surgeon, psychologist, podiatrist, or dentist.

21(c) Any institution described in subdivision (a) or its medical
22staff that violates subdivision (a) is guilty of a misdemeanor and
23shall be punished by a fine of not less than two hundred dollars
24($200) nor more than one thousand two hundred dollars ($1,200).

25

SEC. 3.  

Section 2216.5 is added to the Business and Professions
26Code
, to read:

27

2216.5.  

An outpatient setting accredited pursuant to Section
281248.1 of the Health and Safety Code is subject to the requirements
29of Section 1216, subdivision (f) of Section 127280, and Section
30128737 of the Health and Safety Code.

31

SEC. 4.  

Section 1204 of the Health and Safety Code is amended
32to read:

33

1204.  

Clinics eligible for licensure pursuant to this chapter are
34primary care clinics and specialty clinics.

35(a)  (1)  Only the following defined classes of primary care
36clinics shall be eligible for licensure:

37(A)  A “community clinic” means a clinic operated by a
38tax-exempt nonprofit corporation that is supported and maintained
39in whole or in part by donations, bequests, gifts, grants, government
40funds or contributions, that may be in the form of money, goods,
P10   1or services. In a community clinic, any charges to the patient shall
2be based on the patient’s ability to pay, utilizing a sliding fee scale.
3No corporation other than a nonprofit corporation, exempt from
4 federal income taxation under paragraph (3) of subsection (c) of
5Section 501 of the Internal Revenue Code of 1954 as amended, or
6a statutory successor thereof, shall operate a community clinic;
7provided, that the licensee of any community clinic so licensed on
8the effective date of this section shall not be required to obtain
9tax-exempt status under either federal or state law in order to be
10eligible for, or as a condition of, renewal of its license. No natural
11person or persons shall operate a community clinic.

12(B)  A “free clinic” means a clinic operated by a tax-exempt,
13nonprofit corporation supported in whole or in part by voluntary
14donations, bequests, gifts, grants, government funds or
15contributions, that may be in the form of money, goods, or services.
16In a free clinic there shall be no charges directly to the patient for
17services rendered or for drugs, medicines, appliances, or
18apparatuses furnished. No corporation other than a nonprofit
19corporation exempt from federal income taxation under paragraph
20(3) of subsection (c) of Section 501 of the Internal Revenue Code
21of 1954 as amended, or a statutory successor thereof, shall operate
22a free clinic; provided, that the licensee of any free clinic so
23licensed on the effective date of this section shall not be required
24to obtain tax-exempt status under either federal or state law in
25order to be eligible for, or as a condition of, renewal of its license.
26No natural person or persons shall operate a free clinic.

27(2)  Nothing in this subdivision shall prohibit a community
28clinic or a free clinic from providing services to patients whose
29services are reimbursed by third-party payers, or from entering
30into managed care contracts for services provided to private or
31public health plan subscribers, as long as the clinic meets the
32requirements identified in subparagraphs (A) and (B). For purposes
33of this subdivision, any payments made to a community clinic by
34a third-party payer, including, but not limited to, a health care
35service plan, shall not constitute a charge to the patient. This
36paragraph is a clarification of existing law.

37(b)  The following types of specialty clinics shall be eligible for
38licensure as specialty clinics pursuant to this chapter:

39(1)  begin insert(A)end insertbegin insertend insert A “surgical clinic” means a clinic that is not part of a
40hospital and that provides ambulatory surgical care for patients
P11   1who remain less than 24 hours. A surgical clinic does not include
2any place or establishment owned or leased and operated as a clinic
3or office by one or more physicians or dentists in individual or
4group practice, regardless of the name used publicly to identify
5the place or begin deleteestablishment, provided, however, that physicians or
6dentists may, at their option, apply for licensure.end delete
begin insert establishment.end insert

begin insert

7(B) A physician or dentist may, at his or her option, apply for
8licensure. A surgical clinic shall be eligible for licensure by the
9department regardless of physician or dentist ownership.

end insert

10(2)  A “chronic dialysis clinic” means a clinic that provides less
11than 24-hour care for the treatment of patients with end-stage renal
12disease, including renal dialysis services.

13(3)  A “rehabilitation clinic” means a clinic that, in addition to
14providing medical services directly, also provides physical
15rehabilitation services for patients who remain less than 24 hours.
16Rehabilitation clinics shall provide at least two of the following
17rehabilitation services: physical therapy, occupational therapy,
18social, speech pathology, and audiology services. A rehabilitation
19clinic does not include the offices of a private physician in
20individual or group practice.

21(4)  An “alternative birth center” means a clinic that is not part
22of a hospital and that provides comprehensive perinatal services
23and delivery care to pregnant women who remain less than 24
24hours at the facility.

25

SEC. 5.  

Section 1248.15 of the Health and Safety Code is
26amended to read:

27

1248.15.  

(a) The board shall adopt standards for accreditation
28and, in approving accreditation agencies to perform accreditation
29of outpatient settings, shall ensure that the certification program
30shall, at a minimum, include standards for the following aspects
31of the settings’ operations:

32(1) Outpatient setting allied health staff shall be licensed or
33certified to the extent required by state or federal law.

34(2) (A) Outpatient settings shall have a system for facility safety
35and emergency training requirements.

36(B) There shall be onsite equipment, medication, and trained
37personnel to facilitate handling of services sought or provided and
38to facilitate handling of any medical emergency that may arise in
39connection with services sought or provided.

P12   1(C) In order for procedures to be performed in an outpatient
2setting as defined in Section 1248, the outpatient setting shall do
3one of the following:

4(i) Have a written transfer agreement with a local accredited or
5licensed acute care hospital, approved by the facility’s medical
6staff.

7(ii) Permit surgery only by a licensee who has admitting
8privileges at a local accredited or licensed acute care hospital, with
9the exception that licensees who may be precluded from having
10admitting privileges by their professional classification or other
11administrative limitations, shall have a written transfer agreement
12with licensees who have admitting privileges at local accredited
13or licensed acute care hospitals.

14(iii) Submit for approval by an accrediting agency a detailed
15procedural plan for handling medical emergencies that shall be
16reviewed at the time of accreditation. No reasonable plan shall be
17disapproved by the accrediting agency.

18(D) begin deleteIn addition to the requirements imposed in subparagraph
19(C), the end delete
begin insertThe end insertoutpatient setting shall submit for approval by an
20accreditation agency at the time of accreditation a detailed plan,
21standardized procedures, and protocols to be followed in the event
22of serious complications or side effects from surgery that would
23place a patient at high risk for injury or harm or to govern
24emergency and urgent care situations. The plan shall include, at a
25minimum, that if a patient is being transferred to a local accredited
26or licensed acute care hospital, the outpatient setting shall do all
27of the following:

28(i) Notify the individual designated by the patient to be notified
29in case of an emergency.

30(ii) Ensure that the mode of transfer is consistent with the
31patient’s medical condition.

32(iii) Ensure that all relevant clinical information is documented
33and accompanies the patient at the time of transfer.

34(iv) Continue to provide appropriate care to the patient until the
35transfer is effectuated.

36(E) All physicians and surgeons transferring patients from an
37outpatient setting shall agree to cooperate with the medical staff
38peer review process on the transferred case, the results of which
39shall be referred back to the outpatient setting, if deemed
40appropriate by the medical staff peer review committee. If the
P13   1medical staff of the acute care facility determines that inappropriate
2care was delivered at the outpatient setting, the acute care facility’s
3peer review outcome shall be reported, as appropriate, to the
4accrediting body or in accordance with existing law.

5(3) The outpatient setting shall permit surgery by a dentist acting
6within his or her scope of practice under Chapter 4 (commencing
7with Section 1600) of Division 2 of the Business and Professions
8Code or physician and surgeon, osteopathic physician and surgeon,
9or podiatrist acting within his or her scope of practice under
10Chapter 5 (commencing with Section 2000) of Division 2 of the
11Business and Professions Code or the Osteopathic Initiative Act.
12The outpatient setting may, in its discretion, permit anesthesia
13service by a certified registered nurse anesthetist acting within his
14or her scope of practice under Article 7 (commencing with Section
152825) of Chapter 6 of Division 2 of the Business and Professions
16Code.

17(4) Outpatient settings shall have a system for maintaining
18clinical records.

19(5) Outpatient settings shall have a system for patient care and
20monitoring procedures.

21(6) (A)  Outpatient settings shall have a system for quality
22assessment and improvement.

23(B) begin insert(i)end insertbegin insertend insert Members of the medical staff and other practitioners
24who are granted clinical privileges shall be professionally qualified
25and appropriately credentialed for the performance of privileges
26granted. The outpatient setting shall grant privileges in accordance
27with recommendations from qualified health professionals, and
28credentialing standards established by the outpatient setting.

begin insert

29(ii) Each physician and surgeon who performs procedures in
30an outpatient setting that requires the outpatient setting to be
31accredited shall be peer reviewed, as described in Section 805 of
32the Business and Professions Code, including when the outpatient
33setting has only one physician and surgeon. The peer review shall
34be performed by California licensed physicians who are qualified
35by education experience to perform the same types of procedures.

end insert

36(C) Clinical privileges shall be periodically reappraised by the
37outpatient setting. The scope of procedures performed in the
38outpatient setting shall be periodically reviewed and amended as
39appropriate.

P14   1(7) Outpatient settings regulated by this chapter that have
2multiple service locations shall have all of the sites inspected.

3(8) Outpatient settings shall post the certificate of accreditation
4in a location readily visible to patients and staff.

5(9) Outpatient settings shall post the name and telephone number
6of the accrediting agency with instructions on the submission of
7complaints in a location readily visible to patients and staff.

8(10) Outpatient settings shall have a written discharge criteria.

9(b) Outpatient settings shall have a minimum of two staff
10persons on the premises, one of whom shall either be a licensed
11physician and surgeon or a licensed health care professional with
12current certification in advanced cardiac life support (ACLS), as
13long as a patient is present who has not been discharged from
14supervised care. Transfer to an unlicensed setting of a patient who
15does not meet the discharge criteria adopted pursuant to paragraph
16(10) of subdivision (a) shall constitute unprofessional conduct.

17(c) An accreditation agency may include additional standards
18in its determination to accredit outpatient settings if these are
19approved by the board to protect the public health and safety.

20(d) No accreditation standard adopted or approved by the board,
21and no standard included in any certification program of any
22 accreditation agency approved by the board, shall serve to limit
23the ability of any allied health care practitioner to provide services
24within his or her full scope of practice. Notwithstanding this or
25any other provision of law, each outpatient setting may limit the
26privileges, or determine the privileges, within the appropriate scope
27of practice, that will be afforded to physicians and allied health
28care practitioners who practice at the facility, in accordance with
29credentialing standards established by the outpatient setting in
30compliance with this chapter. Privileges may not be arbitrarily
31restricted based on category of licensure.

32(e) The board shall adopt standards that it deems necessary for
33outpatient settings that offer in vitro fertilization.

34(f) The board may adopt regulations it deems necessary to
35specify procedures that should be performed in an accredited
36outpatient setting for facilities or clinics that are outside the
37definition of outpatient setting as specified in Section 1248.

38(g) As part of the accreditation process, the accrediting agency
39shall conduct a reasonable investigation of the prior history of the
40outpatient setting, including all licensed physicians and surgeons
P15   1who have an ownership interest therein, to determine whether there
2have been any adverse accreditation decisions rendered against
3them. For the purposes of this section, “conducting a reasonable
4investigation” means querying the Medical Board of California
5and the Osteopathic Medical Board of California to ascertain if
6either the outpatient setting has, or, if its owners are licensed
7physicians and surgeons, if those physicians and surgeons have,
8been subject to an adverse accreditation decision.

9

SEC. 6.  

Section 1248.3 of the Health and Safety Code is
10amended to read:

11

1248.3.  

(a)  begin deleteCertificates end deletebegin insertAn end insertbegin insertinitial certificateend insertbegin insert end insertof accreditation
12issued tobegin insert anend insert outpatientbegin delete settingsend deletebegin insert settingend insert by an accreditation agency
13shall be valid for not more thanbegin insert two years, and a renewal certificate
14shall be valid for not more thanend insert
three years.

15(b)  The outpatient setting shall notify the accreditation agency
16within 30 days of any significant change in ownership, including,
17but not limited to, a merger, change in majority interest,
18consolidation, name change, change in scope of services, additional
19services, or change in locations.

20(c)  Except for disclosures to the division or to the Division of
21Medical Quality under this chapter, an accreditation agency shall
22not disclose information obtained in the performance of
23accreditation activities under this chapter that individually identifies
24patients, individual medical practitioners, or outpatient settings.
25 Neither the proceedings nor the records of an accreditation agency
26or the proceedings and records of an outpatient setting related to
27performance of quality assurance or accreditation activities under
28this chapter shall be subject to discovery, nor shall the records or
29proceedings be admissible in a court of law. The prohibition
30relating to discovery and admissibility of records and proceedings
31does not apply to any outpatient setting requesting accreditation
32in the event that denial or revocation of that outpatient setting’s
33accreditation is being contested. Nothing in this section shall
34prohibit the accreditation agency from making discretionary
35disclosures of information to an outpatient setting pertaining to
36the accreditation of that outpatient setting.

37

SEC. 7.  

Section 1248.35 of the Health and Safety Code is
38amended to read:

39

1248.35.  

(a) Every outpatient settingbegin delete whichend deletebegin insert thatend insert is accredited
40shall be inspected by the accreditation agency and may also be
P16   1inspected by the Medical Board of California. The Medical Board
2of California shall ensure that accreditation agencies inspect
3outpatient settings.

4(b) Unless otherwise specified, the following requirements apply
5to inspections described in subdivision (a).

6(1) The frequency of inspection shall depend upon the type and
7complexity of the outpatient setting to be inspected.

8(2) Inspections shall be conducted no less often than once every
9three years by the accreditation agency and as often as necessary
10by the Medical Board of California to ensure the quality of care
11provided.begin insert After the initial inspection for accreditation, all
12subsequent inspections shall be unannounced.end insert

13(3) The Medical Board of California or the accreditation agency
14may enter and inspect any outpatient setting that is accredited by
15an accreditation agency at any reasonable time to ensure
16compliance with, or investigate an alleged violation of, any
17standard of the accreditation agency or any provision of this
18chapter.

19(c) If an accreditation agency determines, as a result of its
20inspection, that an outpatient setting is not in compliance with the
21standards under which it was approved, the accreditation agency
22may do any of the following:

23(1) Require correction of any identified deficiencies within a
24set timeframe. Failure to comply shall result in the accrediting
25agency issuing a reprimand or suspending or revoking the
26outpatient setting’s accreditation.

27(2) Issue a reprimand.

28(3) Place the outpatient setting on probation, during which time
29the setting shall successfully institute and complete a plan of
30correction, approved by the board or the accreditation agency, to
31correct the deficiencies.

32(4) Suspend or revoke the outpatient setting’s certification of
33accreditation.

34(d) (1) Except as is otherwise provided in this subdivision,
35before suspending or revoking a certificate of accreditation under
36this chapter, the accreditation agency shall provide the outpatient
37setting with notice of any deficiencies and the outpatient setting
38shall agree with the accreditation agency on a plan of correction
39that shall give the outpatient setting reasonable time to supply
40information demonstrating compliance with the standards of the
P17   1accreditation agency in compliance with this chapter, as well as
2the opportunity for a hearing on the matter upon the request of the
3outpatient setting. During the allotted time to correct the
4deficiencies, the plan of correction, which includes the deficiencies,
5shall be conspicuously posted by the outpatient setting in a location
6accessible to public view. Within 10 days after the adoption of the
7plan of correction, the accrediting agency shall send a list of
8deficiencies and the corrective action to be taken to the board and
9to the California State Board of Pharmacy if an outpatient setting
10is licensed pursuant to Article 14 (commencing with Section 4190)
11of Chapter 9 of Division 2 of the Business and Professions Code.
12The accreditation agency may immediately suspend the certificate
13of accreditation before providing notice and an opportunity to be
14heard, but only when failure to take the action may result in
15imminent danger to the health of an individual. In such cases, the
16accreditation agency shall provide subsequent notice and an
17opportunity to be heard.

18(2) If an outpatient setting does not comply with a corrective
19action within a timeframe specified by the accrediting agency, the
20accrediting agency shall issue a reprimand, and may either place
21the outpatient setting on probation or suspend or revoke the
22accreditation of the outpatient setting, and shall notify the board
23of its action. This section shall not be deemed to prohibit an
24outpatient setting that is unable to correct the deficiencies, as
25specified in the plan of correction, for reasons beyond its control,
26from voluntarily surrendering its accreditation prior to initiation
27of any suspension or revocation proceeding.

28(e) The accreditation agency shall, within 24 hours, report to
29the board if the outpatient setting has been issued a reprimand or
30if the outpatient setting’s certification of accreditation has been
31suspended or revoked or if the outpatient setting has been placed
32on probation. If an outpatient setting has been issued a license by
33the California State Board of Pharmacy pursuant to Article 14
34(commencing with Section 4190) of Chapter 9 of Division 2 of
35the Business and Professions Code, the accreditation agency shall
36also send this report to the California State Board of Pharmacy
37within 24 hours.

38(f) The accreditation agency, upon receipt of a complaint from
39the board that an outpatient setting poses an immediate risk to
40public safety, shall inspect the outpatient setting and report its
P18   1findings of inspection to the board within five business days. If an
2accreditation agency receives any other complaint from the board,
3it shall investigate the outpatient setting and report its findings of
4investigation to the board within 30 days.

5(g) Reports on the results of any inspection shall be kept on file
6with the board and the accreditation agency along with the plan
7of correction and the comments of the outpatient setting. The
8inspection report may include a recommendation for reinspection.
9All final inspection reports, which include the lists of deficiencies,
10plans of correction or requirements for improvements and
11correction, and corrective action completed, shall be public records
12open to public inspection.

13(h) If one accrediting agency denies accreditation, or revokes
14or suspends the accreditation of an outpatient setting, this action
15shall apply to all other accrediting agencies. An outpatient setting
16that is denied accreditation is permitted to reapply for accreditation
17with the same accrediting agency. The outpatient setting also may
18apply for accreditation from another accrediting agency, but only
19if it discloses the full accreditation report of the accrediting agency
20that denied accreditation. Any outpatient setting that has been
21denied accreditation shall disclose the accreditation report to any
22other accrediting agency to which it submits an application. The
23new accrediting agency shall ensure that all deficiencies have been
24corrected and conduct a new onsite inspection consistent with the
25standards specified in this chapter.

26(i) If an outpatient setting’s certification of accreditation has
27been suspended or revoked, or if the accreditation has been denied,
28the accreditation agency shall do all of the following:

29(1) Notify the board of the action.

30(2) Send a notification letter to the outpatient setting of the
31action. The notification letter shall state that the setting is no longer
32allowed to perform procedures that require outpatient setting
33accreditation.

34(3) Require the outpatient setting to remove its accreditation
35certification and to post the notification letter in a conspicuous
36location, accessible to public view.

37(j) The board may take any appropriate action it deems necessary
38pursuant to Section 1248.7 if an outpatient setting’s certification
39of accreditation has been suspended or revoked, or if accreditation
40has been denied.

P19   1

SEC. 8.  

No reimbursement is required by this act pursuant to
2Section 6 of Article XIII B of the California Constitution because
3the only costs that may be incurred by a local agency or school
4district will be incurred because this act creates a new crime or
5infraction, eliminates a crime or infraction, or changes the penalty
6for a crime or infraction, within the meaning of Section 17556 of
7the Government Code, or changes the definition of a crime within
8the meaning of Section 6 of Article XIII B of the California
9Constitution.



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