Amended in Senate August 10, 2016

Amended in Senate June 21, 2016

Amended in Senate May 31, 2016

Amended in Assembly April 5, 2016

California Legislature—2015–16 Regular Session

Assembly BillNo. 2325


Introduced by Assembly Member Bonilla

February 18, 2016


An act to amend Section 103885 of the Health and Safety Code, relating to cancer.

LEGISLATIVE COUNSEL’S DIGEST

AB 2325, as amended, Bonilla. Ken Maddy California Cancer Registry.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law authorizes the department to designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries to provide cancer incidence data. Existing law requires any hospital or other facility providing therapy to cancer patients within a cancer reporting area to report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. Existing law provides that if the hospital or other facility fails to report in a format prescribed by the department, the department’s authorized representative is authorized to access the information from the hospital or the facility and report it in the appropriate format. In these cases, existing law requires the hospital or other health facility to reimburse the department or the authorized representative for its cost to access and report the information. Existing law also requires any physician, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients to report each cancer case to the department or the authorized representative of the department, except for those cases directly referred to a treatment facility or those previously admitted to a treatment facility for diagnosis or treatment of that instance of cancer.

This bill, on or after January 1, 2019,begin delete wouldend deletebegin insert would, among other things,end insert require a pathologist diagnosing cancer to report cancer diagnoses to the departmentbegin insert by electronic means, including, but not limited to,end insert either directly from an electronic medical record or using a designated Internet Web portal provided by the department. If a pathologist fails to report electronically and with an approved format, the bill would authorize the department’s authorized representative to access the information from the pathologist in an appropriate alternative format. In these cases, the bill would require the pathologist to reimburse the department or the authorized representative for its cost to access and report the information. The bill would require the department to prescribe the data required to be included in the reports and to work collaboratively with stakeholders to designate a standardized electronic format for submission of the reports.

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

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

P2    1

SECTION 1.  

Section 103885 of the Health and Safety Code
2 is amended to read:

3

103885.  

(a) The director shall establish a statewide system for
4the collection of information determining the incidence of cancer,
5using population-based cancer registries modeled after the Cancer
6Surveillance Program of Orange County. As of the effective date
7of this section, the director shall begin phasing in the statewide
8cancer reporting system. By July 1, 1988, all county or regional
9registries shall be implemented or initiated. By July 1, 1990, the
10statewide cancer reporting system shall be fully operational. Within
P3    160 days of the effective date of this section, the director shall
2submit an implementation and funding schedule to the Legislature.

3(b) The department may designate any demographic parts of
4the state as regional cancer incidence reporting areas and may
5 establish regional cancer registries, with the responsibility and
6authority to carry out the intent of this section in designated areas.
7Designated regional registries shall provide, on a timely basis,
8cancer incidence data as designated by the state department to the
9department. The department may establish a competitive process
10to receive applications for, and issue, the award of a contract, grant,
11or allocation of funds, including, but not limited to, a cooperative
12agreement, subvention agreement, or any other agreement allowed
13by law, to an agency, including, but not limited to, a health systems
14agency, single county health department, multicounty health
15department grouping, or nonprofit professional association to
16operate the statewide cancer reporting system and to enter into
17contracts, or issue grants or funding allocations to other agencies
18representing a designated cancer reporting region for the purposes
19of collecting and collating cancer incidence data. The award of
20these contracts, grants, or funding allocations shall be exempt from
21Part 2 (commencing with Section 10100) of Division 2 of the
22Public Contract Code. The department shall include appropriate
23terms and conditions in a contract, grant, or funding allocation to
24ensure the proper use of state funds, including provision for
25reimbursement of allowable costs, financial reporting, program
26performance reporting, monitoring of subgrants, subcontracts, or
27suballocations to an agency representing a designated cancer
28reporting region, retention and access requirements for records,
29data use and management, independent auditing, termination, and
30disposition of assets acquired under the contract, grant, or funding
31allocation.

32(c) The director shall designate cancer as a disease required to
33be reported in the state or any demographic parts of the state in
34which cancer information is collected under this section. All
35cancers diagnosed or treated in the reporting area shall thereafter
36be reported to the representative of the department authorized to
37compile the cancer data, or any individual, agency, or organization
38designated to cooperate with that representative.

39(d) (1) Any hospital or other facility providing therapy to cancer
40patients within an area designated as a cancer reporting area shall
P4    1report each case of cancer to the department or the authorized
2representative of the department in a format prescribed by the
3department. If the hospital or other facility fails to report in a
4format prescribed by the department, the department’s authorized
5representative may access the information from the hospital or the
6facility and report it in the appropriate format. In these cases, the
7hospital or other health facility shall reimburse the state department
8or the authorized representative for its cost to access and report
9the information.

10(2) Any physician and surgeon, dentist, podiatrist, or other health
11care practitioner diagnosing or providing treatment for cancer
12patients shall report each cancer case to the department or the
13authorized representative of the department, except for those cases
14directly referred to a treatment facility or those previously admitted
15to a treatment facility for diagnoses or treatment of that instance
16of cancer.

17(3) begin insert(A)end insertbegin insertend insert On or after January 1, 2019, a pathologist diagnosing
18cancer shall report cancer diagnoses to the department utilizing
19the College of American Pathologists cancer protocols or any other
20standardized format approved by the department.begin delete Reportingend delete

21begin insert(B)end insertbegin insertend insertbegin insertReportingend insert shall be by electronic means,begin insert including, but not
22limited to,end insert
either directly from an electronic medical record or
23using a designated Internet Web portal that the department shall
24provide for pathologists’ use. If a pathologist fails to report
25electronically and with an approved format, the department’s
26authorized representative may access the information from the
27pathologist in an appropriate alternative format. In these cases, the
28pathologist shall reimburse the department or the authorized
29representative for its cost to access and report the information.begin delete Aend delete

30begin insert(C)end insertbegin insertend insertbegin insertAend insert pathologist shall not be responsible for acquiring missing
31or inaccessible patient demographic information not provided to
32him or her beyond the content of the required cancer-specific data
33elements.begin delete Forend delete

34begin insert(D)end insertbegin insertend insertbegin insertForend insert purposes of reports submitted pursuant to this paragraph,
35the department shall prescribe the data required to be included in
36the report, work collaboratively with stakeholders to designate a
37standardized electronic format for submission, and designate an
38Internet Web portal for electronic submission.

begin insert

39
(E) This paragraph shall not be interpreted to require a
40pathologist to submit the same pathology report to the department,
P5    1regardless of format, more than once. If a pathology report is
2submitted by a pathologist electronically, pursuant to this
3paragraph, the same pathology report is not required to be
4submitted to the department by any other means.

end insert

5(e) Any hospital or other facility that is required to reimburse
6the department or its authorized representative for the cost to access
7and report the information pursuant to subdivision (d) shall provide
8payment to the department or its authorized representative within
960 days of the date this payment is demanded. In the event any
10hospital or other facility fails to make the payment to the
11department or its authorized representative within 60 days of the
12date the payment is demanded, the department or its authorized
13representative may, at its discretion, assess a late fee not to exceed
14112 percent per month of the outstanding balance. Further, in the
15event that the department or its authorized representative takes a
16legal action to recover its costs and any associated fees, and the
17department or its authorized representative receives a judgment in
18its favor, the hospital or other facility shall also reimburse the
19department or its authorized representative for any additional costs
20it incurred to pursue the legal action. Late fees and payments made
21to the department by hospitals or other facilities pursuant to this
22subdivision shall be considered as reimbursements of the additional
23costs incurred by the department.

24(f) All physicians and surgeons, hospitals, outpatient clinics,
25nursing homes and all other facilities, individuals, or agencies
26providing diagnostic or treatment services to patients with cancer
27shall grant to the department or the authorized representative access
28to all records that would identify cases of cancer or would establish
29characteristics of the cancer, treatment of the cancer, or medical
30status of any identified cancer patient. Willful failure to grant
31access to those records shall be punishable by a fine of up to five
32hundred dollars ($500) each day access is refused. Any fines
33collected pursuant to this subdivision shall be deposited in the
34General Fund.

35(g) (1) Except as otherwise provided in this section, all
36information collected pursuant to this section shall be confidential.
37For purposes of this section, this information shall be referred to
38as “confidential information.”

39(2) The department and any regional cancer registry designated
40by the department shall use the information to determine the
P6    1sources of malignant neoplasms and evaluate measures designed
2to eliminate, alleviate, or ameliorate their effect.

3(3) Persons with a valid scientific interest who are engaged in
4demographic, epidemiological, or other similar studies related to
5health who meet qualifications as determined by the department,
6and who agree, in writing, to maintain confidentiality, may be
7authorized access to confidential information.

8(4) The department and any regional cancer registry designated
9by the department may enter into agreements to furnish confidential
10information to other states’ cancer registries, federal cancer control
11agencies, local health officers, or health researchers for the
12purposes of determining the sources of cancer and evaluating
13measures designed to eliminate, alleviate, or ameliorate their effect.
14Before confidential information is disclosed to those agencies,
15officers, researchers, or out-of-state registries, the requesting entity
16shall agree in writing to maintain the confidentiality of the
17information, and in the case of researchers, shall also do both of
18the following:

19(A) Obtain approval of their committee for the protection of
20human subjects established in accordance with Part 46
21(commencing with Section 46.101) of Title 45 of the Code of
22Federal Regulations.

23(B) Provide documentation to the department that demonstrates
24to the department’s satisfaction that the entity has established the
25procedures and ability to maintain the confidentiality of the
26information.

27(5) Notwithstanding any otherbegin delete provision ofend delete law, any disclosure
28authorized by this section shall include only the information
29necessary for the stated purpose of the requested disclosure, used
30for the approved purpose, and not be further disclosed.

31(6) The furnishing of confidential information to the department
32or its authorized representative in accordance with this section
33shall not expose any person, agency, or entity furnishing
34information to liability, and shall not be considered a waiver of
35any privilege or a violation of a confidential relationship.

36(7) The department shall maintain an accurate record of all
37persons who are given access to confidential information. The
38record shall include: the name of the person authorizing access;
39name, title, address, and organizational affiliation of persons given
40access; dates of access; and the specific purpose for which
P7    1information is to be used. The record of access shall be open to
2public inspection during normal operating hours of the department.

3(8) Notwithstanding any other law, no part of the confidential
4information shall be available for subpoena, nor shall it be
5disclosed, discoverable, or compelled to be produced in any civil,
6criminal, administrative, or other proceeding, nor shall this
7information be deemed admissible as evidence in any civil,
8criminal, administrative, or other tribunal or court for any reason.

9(9) Nothing in this subdivision shall prohibit the publication by
10the department of reports and statistical compilations that do not
11in any way identify individual cases or individual sources of
12information.

13(10) Notwithstanding the restrictions in this subdivision, the
14individual to whom the information pertains shall have access to
15his or her own information in accordance with Chapter 1
16(commencing with Section 1798) of Title 1.8 of the Civil Code.

17(h) For the purpose of this section, “cancer” means either of the
18following:

19(1) All malignant neoplasms, regardless of the tissue of origin,
20including malignant lymphoma, Hodgkins disease, and leukemia,
21but excluding basal cell and squamous cell carcinoma of the skin.

22(2) All primary intracranial and central nervous system (CNS)
23tumors occurring in the following sites, irrespective of histologic
24type: brain, meninges, spinal cord, caudae equina, cranial nerves
25and other parts of the CNS, pituitary gland, pineal gland, and
26craniopharyngeal duct.

27(i) Nothing in this section shall preempt the authority of facilities
28or individuals providing diagnostic or treatment services to patients
29with cancer to maintain their own facility-based cancer registries.

30(j) It is the intent of the Legislature that the department, in
31establishing a system pursuant to this section, maximize the use
32of available federal funds.



O

    95