Amended in Assembly January 4, 2016

Amended in Assembly April 20, 2015

California Legislature—2015–16 Regular Session

Assembly BillNo. 1174


Introduced by Assembly Member Bonilla

February 27, 2015


An act tobegin delete add Sections 100240, 100241, 100242, and 100243 to the Health and Safety Code, relating to health research.end deletebegin insert amend Section 800 of the Business and Professions Code, relating to healing arts.end insert

LEGISLATIVE COUNSEL’S DIGEST

AB 1174, as amended, Bonilla. begin deleteHealth research: women’s health. end deletebegin insertHealing arts: licensee records.end insert

begin insert

Existing law provides for the licensure and regulation of various professions and vocations by boards within the Department of Consumer Affairs. Existing law requires various state licensing boards, including the Medical Board of California and the Board of Psychology, to create and maintain a central file of the names of licensees to provide an individual historical record for each licensee with information on acts of licensee misconduct and discipline, as specified.

end insert
begin insert

This bill would add the California Board of Podiatric Medicine to the list of state licensing boards required to create and maintain such records.

end insert
begin delete

Existing law establishes the Inclusion of Women and Minorities in Clinical Research Act, which requires a grantee, as defined, in conducting or supporting a project of clinical research, as defined, to ensure that women of all ages, and members of minority groups, as defined, are included as subjects in the clinical research projects, except under prescribed circumstances. Existing law also requires state agencies to, and would declare legislative intent that the University of California include in specified progress reports, data on the extent to which state funds administered by state agencies and the University of California are used by grantees for research on diseases, disorders, and health conditions, that includes women and minorities in the research trials, and that studies diseases, disorders, and health conditions of particular concern to women and minorities. Existing law also states the legislative intent that research include, but not be limited to, specified diseases, disorders, and health conditions.

end delete
begin delete

This bill would create the State Contingency Fund for Ancillary Costs and the Ancillary Costs Committee. The bill would authorize the fund to receive private donations. The bill would require the committee to develop grant criteria once a to be determined amount is deposited into the fund. The bill would authorize the committee to award, on a competitive basis, grants to various organizations, to increase patient access to cancer clinical trials.

end delete

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

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

P2    1begin insert

begin insertSECTION 1.end insert  

end insert

begin insertSection 800 of the end insertbegin insertBusiness and Professions Codeend insert
2begin insert is amended to read:end insert

3

800.  

(a) The Medical Board of California, the Board of
4Psychology, the Dental Board of California, the Dental Hygiene
5Committee of California, the Osteopathic Medical Board of
6California, the State Board of Chiropractic Examiners, the Board
7of Registered Nursing, the Board of Vocational Nursing and
8Psychiatric Technicians of the State of California, the State Board
9of Optometry, the Veterinary Medical Board, the Board of
10Behavioral Sciences, the Physical Therapy Board of California,
11the California State Board of Pharmacy, the Speech-Language
12Pathology and Audiology and Hearing Aid Dispensers Board, the
13California Board of Occupational Therapy, the Acupuncture Board,
14begin insert the California Board of Podiatric Medicine,end insert and the Physician
15 Assistant Board shall each separately create and maintain a central
16file of the names of all persons who hold a license, certificate, or
17similar authority from that board. Each central file shall be created
P3    1and maintained to provide an individual historical record for each
2licensee with respect to the following information:

3(1) Any conviction of a crime in this or any other state that
4constitutes unprofessional conduct pursuant to the reporting
5requirements of Section 803.

6(2) Any judgment or settlement requiring the licensee or his or
7her insurer to pay any amount of damages in excess of three
8thousand dollars ($3,000) for any claim that injury or death was
9proximately caused by the licensee’s negligence, error or omission
10in practice, or by rendering unauthorized professional services,
11pursuant to the reporting requirements of Section 801 or 802.

12(3) Any public complaints for which provision is made pursuant
13to subdivision (b).

14(4) Disciplinary information reported pursuant to Section 805,
15including any additional exculpatory or explanatory statements
16submitted by the licentiate pursuant to subdivision (f) of Section
17805. If a court finds, in a final judgment, that the peer review
18resulting in the 805 report was conducted in bad faith and the
19licensee who is the subject of the report notifies the board of that
20finding, the board shall include that finding in the central file. For
21purposes of this paragraph, “peer review” has the same meaning
22as defined in Section 805.

23(5) Information reported pursuant to Section 805.01, including
24any explanatory or exculpatory information submitted by the
25licensee pursuant to subdivision (b) of that section.

26(b) (1) Each board shall prescribe and promulgate forms on
27which members of the public and other licensees or certificate
28holders may file written complaints to the board alleging any act
29of misconduct in, or connected with, the performance of
30professional services by the licensee.

31(2) If a board, or division thereof, a committee, or a panel has
32failed to act upon a complaint or report within five years, or has
33found that the complaint or report is without merit, the central file
34shall be purged of information relating to the complaint or report.

35(3) Notwithstanding this subdivision, the Board of Psychology,
36the Board of Behavioral Sciences, and the Respiratory Care Board
37of California shall maintain complaints or reports as long as each
38board deems necessary.

39(c) (1) The contents of any central file that are not public
40records under any otherbegin delete provision ofend delete law shall be confidential
P4    1except that the licensee involved, or his or her counsel or
2representative, shall have the right to inspect and have copies made
3of his or her complete file except for the provision that may
4disclose the identity of an information source. For the purposes of
5this section, a board may protect an information source by
6providing a copy of the material with only those deletions necessary
7to protect the identity of the source or by providing a
8comprehensive summary of the substance of the material.
9Whichever method is used, the board shall ensure that full
10disclosure is made to the subject of any personal information that
11could reasonably in any way reflect or convey anything detrimental,
12disparaging, or threatening to a licensee’s reputation, rights,
13benefits, privileges, or qualifications, or be used by a board to
14make a determination that would affect a licensee’s rights, benefits,
15privileges, or qualifications. The information required to be
16disclosed pursuant to Section 803.1 shall not be considered among
17the contents of a central file for the purposes of this subdivision.

18(2) The licensee may, but is not required to, submit any
19additional exculpatory or explanatory statement or other
20information that the board shall include in the central file.

21(3) Each board may permit any law enforcement or regulatory
22agency when required for an investigation of unlawful activity or
23for licensing, certification, or regulatory purposes to inspect and
24have copies made of that licensee’s file, unless the disclosure is
25otherwise prohibited by law.

26(4) These disclosures shall effect no change in the confidential
27status of these records.

begin delete
28

SECTION 1.  

The Legislature finds and declares the following:

29(a) Almost 50 percent of clinical trial studies do not finish in
30time due to low patient participation, recruitment and navigation
31difficulties, and other barriers for patients. Due to economic and
32socioeconomic circumstances and lack of patient knowledge,
33clinical oncology trial participation and retention are both very
34low as they relate to eligible participants.

35(b) Overall, only 3 percent of eligible cancer patients participate
36in clinical trials and of those, only 5 percent of trial participants
37are from racial or ethnic minority communities.

38(c) One barrier that prevents patients from participating in
39federal Food and Drug Administration clinical trials is finances.
P5    1Patients can’t bear the burden of the ancillary costs of participating,
2such as airfare, lodging, rental cars, and fuel.

3

SEC. 2.  

Section 100240 is added to the Health and Safety Code,
4to read:

5

100240.  

The Ancillary Costs Committee is hereby created to
6be made up of private and public health stakeholders.

7

SEC. 3.  

Section 100241 is added to the Health and Safety Code,
8to read:

9

100241.  

(a) The State Contingency Fund for Ancillary Costs
10is hereby created in the State Treasury to be made up of donations
11from private entities. Moneys in the State Contingency Fund for
12Ancillary Costs shall, upon appropriation by the Legislature to the
13committee, be allocated by the committee as provided by Section
14100242.

15(b) The board shall not use more than 10 percent of funds made
16available for the grant program for administrative costs.

17

SEC. 4.  

Section 100242 is added to the Health and Safety Code,
18to read:

19

100242.  

(a) Upon an unspecified amount of moneys being
20donated to the fund, the committee shall establish a grant program
21to determine grant parameters and criteria, and to make grant
22awards.

23(b) In order to increase patient access to clinical trials, the
24committee may award grants from any funds that may be made
25available pursuant to Section 100241, on a competitive basis, to
26both of the following:

27(1) Public and private research institutions and hospitals that
28conduct cancer trials approved by the federal Food and Drug
29Administration approved cancer clinical trials.

30(2) A nonprofit organization described in Section 501(c)(3) of
31the Internal Revenue Code of 1954 which is exempt from income
32tax under Section 501(a) of that code that specializes in direct
33patient support for improved clinical trial enrollment and retention.

34(c) The funds awarded pursuant to subdivision (b) shall be used
35for activities to increase patient access to clinical trials, including,
36but not limited to:

37(1) Payment of ancillary costs for patients and caregivers,
38including, but not limited to:

39(A) Airfare during the clinical trial.

40(B) Lodging during the clinical trial.

P6    1(C) Rental cars during the clinical trial.

2(D) Fuel during the clinical trial

3(E) Meals during the clinical trial.

4(F) Child care costs during the clinical trial.

5(2) Patient navigator services or programs.

6(3) Education and community outreach.

7(4) Patient-friendly technical tools to assist patients in
8identifying available clinical trials.

9

SEC. 5.  

Section 100243 is added to the Health and Safety Code,
10to read:

11

100243.  

Grant recipients shall report to the committee to ensure
12the appropriate use of the funds.

end delete


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