AB 2325: Ken Maddy California Cancer Registry.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2016-09-14
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 departments 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, would, among other things, require a pathologist diagnosing cancer to report cancer diagnoses to the department by electronic means, including, but not limited to, 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 departments 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.
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 departments 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, would, among other things, require a pathologist diagnosing cancer to report cancer diagnoses to the department by electronic means, including, but not limited to, 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 departments 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.
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 departments 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, would would, among other things, require a pathologist diagnosing cancer to report cancer diagnoses to the department by electronic means, including, but not limited to, 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 departments 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.
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 departments 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, would require a pathologist diagnosing cancer to electronically report cancer diagnoses to the department, as specified. department 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 departments 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.
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 departments 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, would require a pathologist diagnosing cancer to electronically report cancer diagnoses to the department in a format prescribed by the department. department, as specified. If a pathologist fails to report in that electronically and with an approved format, the bill would authorize the departments authorized representative to access the information from the pathologist in the 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.
This bill would also require the department to establish a pilot program to enable the department and other authorized users to conduct electronic specific data element searches for the purpose of identifying individuals who meet cancer clinical trial eligibility requirements.
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 departments 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 would delete the reporting exception described above and require any physician, dentist, podiatrist, or other health care practitioner diagnosing and providing treatment for cancer patients to report each cancer case to the department or the authorized representative of the department in a format prescribed by the department. The bill would also require reimbursements if a physician, dentist, podiatrist, or other health care practitioner fails to report in the prescribed format, as specified. The bill would require the department to prescribe the data required to be included in reports submitted by physicians, dentists, podiatrists, or other health care practitioners diagnosing cancer patients and to designate a standardized electronic format for the submission of those reports.
This bill, on or after January 1, 2019, would require a pathologist diagnosing cancer to report cancer diagnoses to the department in a format prescribed by the department. If a pathologist fails to report in that format, the bill would authorize the departments authorized representative to access the information from the pathologist in the appropriate 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 designate a standardized electronic format for submission of the reports.
This bill would also require the department to establish a pilot program to enable the department and other authorized users to conduct electronic specific data element searches for the purpose of identifying individuals who meet cancer clinical trial eligibility requirements.
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 departments 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 would delete the reporting exception described above and require any physician, dentist, podiatrist, or other health care practitioner diagnosing and providing treatment for cancer patients to report each cancer case to the department or the authorized representative of the department in a format prescribed by the department. The bill would also require reimbursements if a physician, dentist, podiatrist, or other health care practitioner fails to report in the prescribed format, as specified. The bill would require the department to prescribe the data required to be included in reports submitted by physicians, dentists, podiatrists, or other health care practitioners diagnosing cancer patients and to designate a standardized electronic format for the submission of those reports.
This bill would also require the department to establish a pilot program to enable the department and other authorized users to conduct electronic specific data element searches for the purpose of identifying individuals who meet cancer clinical trial eligibility requirements.
(a)The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section, the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature.
(b)The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide, on a timely basis, cancer incidence data as designated by the state department to the department. The department may establish a competitive process to receive applications for, and issue, the award of a contract, grant, or allocation of funds, including, but not limited to, a cooperative agreement, subvention agreement, or any other agreement allowed by law, to an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association to operate the statewide cancer reporting system and to enter into contracts, or issue grants or funding allocations to other agencies representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. The award of these contracts, grants, or funding allocations shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. The department shall include appropriate terms and conditions in a contract, grant, or funding allocation to ensure the proper use of state funds, including provision for reimbursement of allowable costs, financial reporting, program performance reporting, monitoring of subgrants, subcontracts, or suballocations to an agency representing a designated cancer reporting region, retention and access requirements for records, data use and management, independent auditing, termination, and disposition of assets acquired under the contract, grant, or funding allocation.
(c)The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative.
(d)(1)Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the departments authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the state department or the authorized representative for its cost to access and report the information.
(2)Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall 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 diagnoses or treatment of that instance of cancer.
(3)(A)On or after January 1, 2019, a pathologist diagnosing cancer shall report cancer diagnoses to the department utilizing the College of American Pathologists cancer protocols or any other standardized format approved by the department.
(B)Reporting shall be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated Internet Web portal that the department shall provide for pathologists use. If a pathologist fails to report electronically and with an approved format, the departments authorized representative may access the information from the pathologist in an appropriate alternative format. In these cases, the pathologist shall reimburse the department or the authorized representative for its cost to access and report the information.
(C)A pathologist shall not be responsible for acquiring missing or inaccessible patient demographic information not provided to him or her beyond the content of the required cancer-specific data elements.
(D)For purposes of reports submitted pursuant to this paragraph, the department shall prescribe the data required to be included in the report, work collaboratively with stakeholders to designate a standardized electronic format for submission, and designate an Internet Web portal for electronic submission.
(E)This paragraph shall not be interpreted to require a pathologist to submit the same pathology report to the department, regardless of format, more than once. If a pathology report is submitted by a pathologist electronically, pursuant to this paragraph, the same pathology report is not required to be submitted to the department by any other means.
(e)Any hospital or other facility that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 11/2 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department.
(f)All physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund.
(g)(1)Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as confidential information.
(2)The department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect.
(3)Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.
(4)The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:
(A)Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.
(B)Provide documentation to the department that demonstrates to the departments satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.
(5)Notwithstanding any other law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
(6)The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(7)The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.
(8)Notwithstanding any other law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
(9)Nothing in this subdivision shall prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.
(10)Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
(h)For the purpose of this section, cancer means either of the following:
(1)All malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin.
(2)All primary intracranial and central nervous system (CNS) tumors occurring in the following sites, irrespective of histologic type: brain, meninges, spinal cord, caudae equina, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct.
(i)Nothing in this section shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own facility-based cancer registries.
(j)It is the intent of the Legislature that the department, in establishing a system pursuant to this section, maximize the use of available federal funds.
(a)The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section, the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature.
(b)The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide, on a timely basis, cancer incidence data as designated by the state department to the department. The department may establish a competitive process to receive applications for, and issue, the award of a contract, grant, or allocation of funds, including, but not limited to, a cooperative agreement, subvention agreement, or any other agreement allowed by law, to an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association to operate the statewide cancer reporting system and to enter into contracts, or issue grants or funding allocations to other agencies representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. The award of these contracts, grants, or funding allocations shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. The department shall include appropriate terms and conditions in a contract, grant, or funding allocation to ensure the proper use of state funds, including provision for reimbursement of allowable costs, financial reporting, program performance reporting, monitoring of subgrants, subcontracts, or suballocations to an agency representing a designated cancer reporting region, retention and access requirements for records, data use and management, independent auditing, termination, and disposition of assets acquired under the contract, grant, or funding allocation.
(c)The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative.
(d)(1)Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the departments authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the state department or the authorized representative for its cost to access and report the information.
(2)Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall 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 diagnoses or treatment of that instance of cancer.
(3)(A)On or after January 1, 2019, a pathologist diagnosing cancer shall report cancer diagnoses to the department utilizing the College of American Pathologists cancer protocols or any other standardized format approved by the department.
(B)Reporting shall be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated Internet Web portal that the department shall provide for pathologists use. If a pathologist fails to report electronically and with an approved format, the departments authorized representative may access the information from the pathologist in an appropriate alternative format. In these cases, the pathologist shall reimburse the department or the authorized representative for its cost to access and report the information.
(C)A pathologist shall not be responsible for acquiring missing or inaccessible patient demographic information not provided to him or her beyond the content of the required cancer-specific data elements.
(D)For purposes of reports submitted pursuant to this paragraph, the department shall prescribe the data required to be included in the report, work collaboratively with stakeholders to designate a standardized electronic format for submission, and designate an Internet Web portal for electronic submission.
(E)This paragraph shall not be interpreted to require a pathologist to submit the same pathology report to the department, regardless of format, more than once. If a pathology report is submitted by a pathologist electronically, pursuant to this paragraph, the same pathology report is not required to be submitted to the department by any other means.
(e)Any hospital or other facility that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 11/2 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department.
(f)All physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund.
(g)(1)Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as confidential information.
(2)The department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect.
(3)Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.
(4)The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:
(A)Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.
(B)Provide documentation to the department that demonstrates to the departments satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.
(5)Notwithstanding any other law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
(6)The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(7)The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.
(8)Notwithstanding any other law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
(9)Nothing in this subdivision shall prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.
(10)Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
(h)For the purpose of this section, cancer means either of the following:
(1)All malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin.
(2)All primary intracranial and central nervous system (CNS) tumors occurring in the following sites, irrespective of histologic type: brain, meninges, spinal cord, caudae equina, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct.
(i)Nothing in this section shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own facility-based cancer registries.
(j)It is the intent of the Legislature that the department, in establishing a system pursuant to this section, maximize the use of available federal funds.
(a)The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section, the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature.
(b)The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide, on a timely basis, cancer incidence data as designated by the state department to the department. The department may establish a competitive process to receive applications for, and issue, the award of a contract, grant, or allocation of funds, including, but not limited to, a cooperative agreement, subvention agreement, or any other agreement allowed by law, to an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association to operate the statewide cancer reporting system and to enter into contracts, or issue grants or funding allocations to other agencies representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. The award of these contracts, grants, or funding allocations shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. The department shall include appropriate terms and conditions in a contract, grant, or funding allocation to ensure the proper use of state funds, including provision for reimbursement of allowable costs, financial reporting, program performance reporting, monitoring of subgrants, subcontracts, or suballocations to an agency representing a designated cancer reporting region, retention and access requirements for records, data use and management, independent auditing, termination, and disposition of assets acquired under the contract, grant, or funding allocation.
(c)The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative.
(d)(1)Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the departments authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the state department or the authorized representative for its cost to access and report the information.
(2)Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall 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 diagnoses or treatment of that instance of cancer.
(3)(A)On or after January 1, 2019, a pathologist diagnosing cancer shall report cancer diagnoses to the department utilizing the College of American Pathologists cancer protocols or any other standardized format approved by the department. Reporting
(B)Reporting shall be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated Internet Web portal that the department shall provide for pathologists use. If a pathologist fails to report electronically and with an approved format, the departments authorized representative may access the information from the pathologist in an appropriate alternative format. In these cases, the pathologist shall reimburse the department or the authorized representative for its cost to access and report the information. A
(C)A pathologist shall not be responsible for acquiring missing or inaccessible patient demographic information not provided to him or her beyond the content of the required cancer-specific data elements. For
(D)For purposes of reports submitted pursuant to this paragraph, the department shall prescribe the data required to be included in the report, work collaboratively with stakeholders to designate a standardized electronic format for submission, and designate an Internet Web portal for electronic submission.
(E)This paragraph shall not be interpreted to require a pathologist to submit the same pathology report to the department, regardless of format, more than once. If a pathology report is submitted by a pathologist electronically, pursuant to this paragraph, the same pathology report is not required to be submitted to the department by any other means.
(e)Any hospital or other facility that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 11/2 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department.
(f)All physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund.
(g)(1)Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as confidential information.
(2)The department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect.
(3)Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.
(4)The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:
(A)Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.
(B)Provide documentation to the department that demonstrates to the departments satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.
(5)Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
(6)The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(7)The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.
(8)Notwithstanding any other law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
(9)Nothing in this subdivision shall prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.
(10)Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
(h)For the purpose of this section, cancer means either of the following:
(1)All malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin.
(2)All primary intracranial and central nervous system (CNS) tumors occurring in the following sites, irrespective of histologic type: brain, meninges, spinal cord, caudae equina, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct.
(i)Nothing in this section shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own facility-based cancer registries.
(j)It is the intent of the Legislature that the department, in establishing a system pursuant to this section, maximize the use of available federal funds.
(a)The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section section, the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature.
(b)The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide, on a timely basis, cancer incidence data as designated by the state department to the department. The department may establish a competitive process to receive applications for, and issue, the award of a contract, grant, or allocation of funds, including, but not limited to, a cooperative agreement, subvention agreement, or any other agreement allowed by law, to an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association to operate the statewide cancer reporting system and to enter into contracts, or issue grants or funding allocations to other agencies representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. The award of these contracts, grants, or funding allocations shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. The department shall include appropriate terms and conditions in a contract, grant, or funding allocation to ensure the proper use of state funds, including provision for reimbursement of allowable costs, financial reporting, program performance reporting, monitoring of subgrants, subcontracts, or suballocations to an agency representing a designated cancer reporting region, retention and access requirements for records, data use and management, independent auditing, termination, and disposition of assets acquired under the contract, grant, or funding allocation.
(c)The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative.
(d)(1)Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the departments authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the state department or the authorized representative for its cost to access and report the information.
(2)Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall 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 diagnoses or treatment of that instance of cancer.
(3)On or after January 1, 2019, a pathologist diagnosing cancer shall electronically report cancer diagnoses to the department utilizing the College of American Pathologists cancer protocols or any other standardized format approved by the department. Reporting shall be by electronic means, either directly from an electronic medical record or using a designated Internet Web portal that the department shall provide for pathologists use. If a pathologist fails to report electronically and with an approved format, the departments authorized representative may access the information from the pathologist in an appropriate alternative format. In these cases, the pathologist shall reimburse the department or the authorized representative for its cost to access and report the information. A pathologist shall not be responsible for acquiring missing or inaccessible patient demographic information not provided to him or her beyond the content of the required cancer-specific data elements. For purposes of reports submitted pursuant to this paragraph, the department shall prescribe the data required to be included in the report and report, work collaboratively with stakeholders to designate a standardized electronic format for submission. submission, and designate an Internet Web portal for electronic submission.
(e)Any hospital or other facility that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 11/2 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department.
(f)All physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund.
(g)(1)Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as confidential information.
(2)The department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect.
(3)Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.
(4)The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:
(A)Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.
(B)Provide documentation to the department that demonstrates to the departments satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.
(5)Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
(6)The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(7)The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.
(8)Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
(9)Nothing in this subdivision shall prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.
(10)Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
(h)For the purpose of this section, cancer means either of the following:
(1)All malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin.
(2)All primary intracranial and central nervous system (CNS) tumors occurring in the following sites, irrespective of histologic type: brain, meninges, spinal cord, caudae equina, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct.
(i)Nothing in this section shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own facility-based cancer registries.
(j)It is the intent of the Legislature that the department, in establishing a system pursuant to this section, maximize the use of available federal funds.
(a)The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature.
(b)The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide, on a timely basis, cancer incidence data as designated by the state department to the department. The department may establish a competitive process to receive applications for, and issue, the award of a contract, grant, or allocation of funds, including, but not limited to, a cooperative agreement, subvention agreement, or any other agreement allowed by law, to an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association to operate the statewide cancer reporting system and to enter into contracts, or issue grants or funding allocations to other agencies representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. The award of these contracts, grants, or funding allocations shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. The department shall include appropriate terms and conditions in a contract, grant, or funding allocation to ensure the proper use of state funds, including provision for reimbursement of allowable costs, financial reporting, program performance reporting, monitoring of subgrants, subcontracts, or suballocations to an agency representing a designated cancer reporting region, retention and access requirements for records, data use and management, independent auditing, termination, and disposition of assets acquired under the contract, grant, or funding allocation.
(c)The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative.
(d)(1)Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the departments authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the state department or the authorized representative for its cost to access and report the information.
(2)Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall 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 diagnoses or treatment of that instance of cancer.
(3)On or after January 1, 2019, a pathologist diagnosing cancer shall electronically report cancer diagnoses to the department in a format prescribed by the department. utilizing the College of American Pathologists cancer protocols or any other standardized format approved by the department. If a pathologist fails to report in that electronically and with an approved format, the departments authorized representative may access the information from the pathologist in the an appropriate alternative format. In these cases, the pathologist shall reimburse the department or the authorized representative for its cost to access and report the information. A pathologist shall not be responsible for acquiring missing or inaccessible patient demographic information not provided to him or her beyond the content of the required cancer-specific data elements. For purposes of reports submitted pursuant to this paragraph, the department shall prescribe the data required to be included in the report and work collaboratively with stakeholders to designate a standardized electronic format for submission.
(e)Any hospital or other facility that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 11/2 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department.
(f)All physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund.
(g)(1)Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as confidential information.
(2)The department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect.
(3)Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.
(4)The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:
(A)Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.
(B)Provide documentation to the department that demonstrates to the departments satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.
(5)Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
(6)The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(7)The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.
(8)Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
(9)Nothing in this subdivision shall prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.
(10)Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
(h)For the purpose of this section, cancer means either of the following:
(1)All malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin.
(2)All primary intracranial and central nervous system (CNS) tumors occurring in the following sites, irrespective of histologic type: brain, meninges, spinal cord, caudae equina, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct.
(i)Nothing in this section shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own facility-based cancer registries.
(j)It is the intent of the Legislature that the department, in establishing a system pursuant to this section, maximize the use of available federal funds.
SEC. 2.Section 103887 is added to the Health and Safety Code, to read:103887.The department shall establish a pilot project to enable the department and users authorized pursuant to this chapter to conduct electronic specific data element searches of the information collected by the statewide cancer registry for the purpose of identifying individuals who meet cancer clinical trial eligibility requirements.
(a)The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature.
(b)The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide, on a timely basis, cancer incidence data as designated by the state department to the department. The department may establish a competitive process to receive applications for, and issue, the award of a contract, grant, or allocation of funds, including, but not limited to, a cooperative agreement, subvention agreement, or any other agreement allowed by law, to an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association to operate the statewide cancer reporting system and to enter into contracts, or issue grants or funding allocations to other agencies representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. The award of these contracts, grants, or funding allocations shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. The department shall include appropriate terms and conditions in a contract, grant, or funding allocation to ensure the proper use of state funds, including provision for reimbursement of allowable costs, financial reporting, program performance reporting, monitoring of subgrants, subcontracts, or suballocations to an agency representing a designated cancer reporting region, retention and access requirements for records, data use and management, independent auditing, termination, and disposition of assets acquired under the contract, grant, or funding allocation.
(c)The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative.
(d)(1)Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the departments authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the state department or the authorized representative for its cost to access and report the information.
(2)Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall report each cancer case to the department or the authorized representative of the department in a format prescribed by the department. If the physician and surgeon, dentist, podiatrist, or other healthcare practitioner fails to report in a format prescribed by the department, the departments authorized representative may access the information from that person and report it in the appropriate format. In these cases, the physician and surgeon, dentist, podiatrist, or other healthcare practitioner shall reimburse the state department or the authorized representative for its cost to access and report the information. For purposes of reports submitted pursuant to this paragraph by a physician and surgeon, dentist, podiatrist, or other healthcare practitioner diagnosing cancer patients, the department shall prescribe the data required to be included in the report and designate a standardized electronic format for submission. department, except for those cases directly referred to a treatment facility or those previously admitted to a treatment facility for diagnoses or treatment of that instance of cancer.
(3)On or after January 1, 2019, a pathologist diagnosing cancer shall report cancer diagnoses to the department in a format prescribed by the department. If a pathologist fails to report in that format, the departments authorized representative may access the information from the pathologist in the appropriate format. In these cases, the pathologist shall reimburse the department or the authorized representative for its cost to access and report the information. For purposes of reports submitted pursuant to this paragraph, the department shall prescribe the data required to be included in the report and designate a standardized electronic format for submission.
(e)Any hospital or other facility, or any physician and surgeon, dentist, podiatrist, or other health care practitioner, facility that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility, or any physician and surgeon, dentist, podiatrist, or other health care practitioner, facility fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 11/2 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility, or the physician and surgeon, dentist, podiatrist, or other health care practitioner, facility shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department.
(f)All physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund.
(g)(1)Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as confidential information.
(2)The department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect.
(3)Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.
(4)The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:
(A)Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.
(B)Provide documentation to the department that demonstrates to the departments satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.
(5)Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
(6)The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(7)The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.
(8)Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
(9)Nothing in this subdivision shall prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.
(10)Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
(h)For the purpose of this section, cancer means either of the following:
(1)All malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin.
(2)All primary intracranial and central nervous system (CNS) tumors occurring in the following sites, irrespective of histologic type: brain, meninges, spinal cord, caudae equina, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct.
(i)Nothing in this section shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own facility-based cancer registries.
(j)It is the intent of the Legislature that the department, in establishing a system pursuant to this section, maximize the use of available federal funds.
SEC. 2.Section 103887 is added to the Health and Safety Code, to read:103887.The department shall establish a pilot project to enable the department and users authorized pursuant to this chapter to conduct electronic specific data element searches of the information collected by the statewide cancer registry for the purpose of identifying individuals who meet cancer clinical trial eligibility requirements.
(a)The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature.
(b)The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide, on a timely basis, cancer incidence data as designated by the state department to the department. The department may establish a competitive process to receive applications for, and issue, the award of a contract, grant, or allocation of funds, including, but not limited to, a cooperative agreement, subvention agreement, or any other agreement allowed by law, to an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association to operate the statewide cancer reporting system and to enter into contracts, or issue grants or funding allocations to other agencies representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. The award of these contracts, grants, or funding allocations shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. The department shall include appropriate terms and conditions in a contract, grant, or funding allocation to ensure the proper use of state funds, including provision for reimbursement of allowable costs, financial reporting, program performance reporting, monitoring of subgrants, subcontracts, or suballocations to an agency representing a designated cancer reporting region, retention and access requirements for records, data use and management, independent auditing, termination, and disposition of assets acquired under the contract, grant, or funding allocation.
(c)The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative.
(d)(1)Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the departments authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the state department or the authorized representative for its cost to access and report the information.
(2)Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall 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. in a format prescribed by the department. If the physician and surgeon, dentist, podiatrist, or other healthcare practitioner fails to report in a format prescribed by the department, the departments authorized representative may access the information from that person and report it in the appropriate format. In these cases, the physician and surgeon, dentist, podiatrist, or other healthcare practitioner shall reimburse the state department or the authorized representative for its cost to access and report the information. For purposes of reports submitted pursuant to this paragraph by a physician and surgeon, dentist, podiatrist, or other healthcare practitioner diagnosing cancer patients, the department shall prescribe the data required to be included in the report and designate a standardized electronic format for submission.
(e)Any hospital or other facility facility, or any physician and surgeon, dentist, podiatrist, or other health care practitioner, that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility facility, or any physician and surgeon, dentist, podiatrist, or other health care practitioner, fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 11/2 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility facility, or the physician and surgeon, dentist, podiatrist, or other health care practitioner, shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department.
(f)All physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund.
(g)(1)Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as confidential information.
(2)The department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect.
(3)Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.
(4)The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:
(A)Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.
(B)Provide documentation to the department that demonstrates to the departments satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.
(5)Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
(6)The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(7)The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.
(8)Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
(9)Nothing in this subdivision shall prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.
(10)Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
(h)For the purpose of this section, cancer means either of the following:
(1)All malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin.
(2)All primary intracranial and central nervous system (CNS) tumors occurring in the following sites, irrespective of histologic type: brain, meninges, spinal cord, caudae equina, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct.
(i)Nothing in this section shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own facility-based cancer registries.
(j)It is the intent of the Legislature that the department, in establishing a system pursuant to this section, maximize the use of available federal funds.
SEC. 2.Section 103887 is added to the Health and Safety Code, to read:103887.The department shall establish a pilot project to enable the department and users authorized pursuant to this chapter to conduct electronic specific data element searches of the information collected by the statewide cancer registry for the purpose of identifying individuals who meet cancer clinical trial eligibility requirements.
|
Date
|
Status
|
|---|---|
| Jun 27, 2016 | From committee: Be placed on second reading file pursuant to Senate Rule 28.8 and ordered to consent calendar. |
| Sep 14, 2016 | Chaptered by Secretary of State - Chapter 354, Statutes of 2016. |
| Sep 14, 2016 | Approved by the Governor. |
| Aug 31, 2016 | Enrolled and presented to the Governor at 4 p.m. |
| Aug 23, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 78. Noes 0. Page 6136.). |
| Aug 23, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. |
| Aug 17, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 39. Noes 0.). |
| Aug 17, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 39. Noes 0. Page 5057.). |
| Aug 17, 2016 | Read third time. Passed. Ordered to the Assembly. |
| Aug 17, 2016 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after August 19 pursuant to Assembly Rule 77. |
| Aug 11, 2016 | Read second time. Ordered to third reading. |
| Aug 10, 2016 | Read third time and amended. Ordered to second reading. |
| Jun 30, 2016 | Ordered to third reading. |
| Jun 30, 2016 | From Consent Calendar. |
| Jun 28, 2016 | Read second time. Ordered to Consent Calendar. |
| Feb 18, 2016 | Read first time. To print. |
| Jun 21, 2016 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on APPR. |
| Jun 8, 2016 | From committee: Do pass and re-refer to Com. on APPR. with recommendation: To Consent Calendar. (Ayes 7. Noes 0.) (June 8). Re-referred to Com. on APPR. |
| May 31, 2016 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on HEALTH. |
| May 12, 2016 | Referred to Com. on HEALTH. |
| May 5, 2016 | Read third time. Passed. Ordered to the Senate. (Ayes 79. Noes 0. Page 4685.) |
| May 5, 2016 | Read third time. Passed. Ordered to the Senate. |
| May 5, 2016 | In Senate. Read first time. To Com. on RLS. for assignment. |
| Apr 28, 2016 | Read second time. Ordered to Consent Calendar. |
| Apr 27, 2016 | From committee: Do pass. To Consent Calendar. (Ayes 19. Noes 0.) (April 27). |
| Apr 20, 2016 | From committee: Do pass and re-refer to Com. on APPR. with recommendation: To Consent Calendar. (Ayes 16. Noes 0.) (April 19). Re-referred to Com. on APPR. |
| Apr 6, 2016 | Re-referred to Com. on HEALTH. |
| Apr 5, 2016 | From committee chair, with author's amendments: Amend, and re-refer to Com. on HEALTH. Read second time and amended. |
| Mar 3, 2016 | Referred to Com. on HEALTH. |
| Feb 19, 2016 | From printer. May be heard in committee March 20. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 23, 2016 | AB 2325 BONILLA Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Aug 17, 2016 | Assembly 3rd Reading AB2325 Bonilla By Gaines | Senate Floor |
Passed |
|
| Jun 8, 2016 | Do pass, but first be re-referred to the Committee on [Appropriations] with the recommendation: To Consent Calendar | Senate Standing Committee on Health |
Passed |
|
| May 5, 2016 | AB 2325 BONILLA Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| Apr 27, 2016 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 19, 2016 | Do pass and be re-referred to the Committee on [Appropriations] with recommendation: To Consent Calendar | Assembly Standing Committee on Health |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| American Cancer Society Action Network | ** Support | Aug 17, 2016 |
| American Cancer Society Cancer Action Network Inc. | ** Support | Aug 17, 2016 |
| California Chronic Care Coalition | ** Support | Aug 17, 2016 |
| California Society Of Pathologists | ** Support | Aug 17, 2016 |
| Stanford Health Care | ** Support | Aug 17, 2016 |
| University Of Southern California The | ** Support | Aug 17, 2016 |
CONCURRENCE IN SENATE AMENDMENTS
CSA1 Bill Id:AB 2325
Author:(Bonilla)
As Amended Ver:August 10, 2016
Majority vote
ASSEMBLY: | 79-0 | (May 5, 2016) | SENATE: | 39-0 | (August 17, 2016) |
Original Committee Reference: HEALTH
SUMMARY: Requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to the Department of Public Health (DPH) by electronic means in a format prescribed by DPH and establishes a pilot project to enable DPH and authorized users to conduct electronic specific data element searches of the information collected by the Ken Maddy California Cancer Registry (CCR).
The Senate amendments clarify that the College of American Pathologists cancer protocols may be used to report cancer diagnoses to DPH in addition to any other standardized format approved by DHCS, specify that a pathologist who submits an electronic report does not need to submit the same report more than once, delete provisions establishing a pilot project within DPH to enable users to conduct electronic specific data element searches of the information collected by the CCR, and make other technical changes.
EXISTING LAW:
- Requires DPH to conduct a program of epidemiological assessments of the incidence of cancer. Requires the program to encompass all areas of the state for which cancer incidence data are available, and to include monitoring of cancers associated with suspected carcinogens encountered by the general public both in occupational locations and in the environment.
- Allows DPH to contract with an agency, including, but not limited to a health systems agency, single or multiple county health departments, or nonprofit professional associations, representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data.
- Requires the Director of DPH (Director) to establish the CCR, a statewide system to collect information on the incidence of cancer using population-based cancer registries. Requires these registries to be implemented or initiated by July 1, 1988, and requires that the statewide cancer reporting system be fully operational by July 1, 1990.
- Requires specified health care providers diagnosing or providing treatment for cancer patients to report all cancers to DPH or an authorized representative, with specified exemptions, and allows DPH access to those records.
- Permits persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet certain qualifications as determined by DPH, and who agree, in writing, to maintain confidentiality, to access confidential information.
- Requires, prior to confidential information being disclosed to designated entities, those designated entities to agree in writing to maintain the confidentiality of the information, and requires researchers to do both of the following:
- Obtain approval of their committee for the protection of human subjects in accordance with federal regulations; and,
- Provide documentation to DPH that demonstrates that the entity has established appropriate procedures and its ability to maintain the confidentiality of the information.
- Specifies that any disclosure of information include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
- Requires DPH to maintain an accurate record of all persons who are given access to confidential information in the CCR including:
- The name of the person authorizing access;
- Name, title, address, and organizational affiliation of persons given access;
- Dates of access; and,
- The specific purpose for which information is to be used.
- Requires records of those who access the CCR, pursuant to 8) above, to be open to public inspection.
- Requires the individual to whom the information pertains to have access to his or her own information made available in the CCR.
FISCAL EFFECT: According to Senate Appropriations Committee, pursuant to Senate Rule 28.8, this bill has negligible state fiscal effect.
COMMENTS: According to the author, this bill creates an innovative, new tool which will allow researchers working on clinical trials to reach out to patients to provide them the opportunity to participate in cutting edge treatments. This bill removes the burden of searching for a cancer clinical trial from patients who are battling cancer and places it on the clinician. The author states that roadblocks to innovative uses of the CCR data stem from long delays in cancer reporting. At best, cancer diagnosis information is reported to the CCR within six to nine months after diagnosis. In reality, it could take one to two years before information is fully reported.
Modernization of the CCR, through electronic pathology reporting, will significantly increase the speed at which diagnosis reports are deposited within the CCR. Because of the real-time reporting, researchers will be able to request diagnosis information to identify matches to ongoing cancer clinical trials. As a result, trial participants will be identified much faster with no burden on cancer patients. Due to the rapid matching of patients to trials and increased participation, cancer therapies will be developed and improved much faster than currently possible because patients will be connected to potentially lifesaving treatments.
According to the DPH and the American Cancer Society 2015 report of California Cancer Facts and Figures, figures show that cancer incidence rates have dropped 13% and death rates have declined 26% in California since 1988. Additionally, the overall incidence rate remains lower than the rest of the nation. Even with those declines, an estimated 172, 090 Californians will be diagnosed with cancer and 58,180 will die of the disease in 2015. The most commonly diagnosed cancers in men will be prostate, lung and colorectal cancers and breast, lung and colorectal cancers will be the most frequently diagnosed among women.
The University of Southern California (USC), a cosponsor of the bill, states that although the CCR is a powerful tool, currently available technologies would allow it to do so faster and more efficiently. Roadblocks to innovative uses of the CCR data stem from long delays in cancer reporting due to reliance on 30 year old methods. At best, cancer diagnosis information is reported to the CCR within six to nine months after diagnosis. In reality, it can take one to two years before that information is fully reported. The long reporting times occur because of inefficient data collection methods. USC argues that this measure will ensure that rapid, real-time electronic cancer diagnosis reporting becomes standard in California, providing higher quality data and allowing new uses of the CCR. For nearly all new cancer diagnoses, the pathology report is the first available record and virtually all are prepared electronically. Yet, pathology reports are not prepared, stored or accessed in a consistent method.
USC states that modernization of the CCR, through electronic pathology reporting, will significantly increase the speed at which diagnosis reports are available within the CCR. Public health officials, researchers and medical providers will be able to monitor cancer occurrence months to years earlier than currently possible and the public will be reassured that the identification of possible new risks will occur as early as possible. USC concludes that this measure will significantly enhance cancer research and monitoring in California through modernization of the CCR.
Analysis Prepared by: Paula Villescaz / HEALTH / (916) 319-2097 FN: 0003979
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB 2325 |
THIRD READING
Bill No: AB 2325
Amended: 8/10/16 in Senate
SENATE HEALTH COMMITTEE: 7-0, 6/8/16
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth
NO VOTE RECORDED: Hall, Wolk
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 79-0, 5/5/16 (Consent) - See last page for vote
SUBJECT: Ken Maddy California Cancer Registry
SOURCE: American Cancer Society Action Network
University of Southern California
DIGEST: This bill requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to the Department of Public Health, as specified, for purposes of the Ken Maddy California Cancer Registry.
Senate Floor Amendments of 8/10/16 clarify reporting requirements by pathologists to the Department of Public Health.
Existing law:
- Requires, pursuant to the Ken Maddy California Cancer Registry (CCR), the Department of Public Health (DPH) to conduct a program of epidemiological assessments of the incidence of cancer. Requires the program to encompass all areas of the state for which cancer incidence data are available, and to include monitoring of cancers associated with suspected carcinogens encountered by the general public both in occupational locations and in the environment.
- Authorizes the DPH Director to enter into contracts as necessary to conduct the CCR, and accept grants of public or private funds for the program on behalf of the state. Requires the Director to analyze available incidence data and prepare reports and perform studies as necessary to identify cancer hazards to the public health and their remedies.
- Requires any hospital or other facility providing therapy to cancer patients to report all cancers diagnosed or treated, in designated cancer reporting areas, to DPH or an authorized representative, and allows DPH access to those records. Requires specified health care providers diagnosing or providing treatment for cancer patients to report all cancers to DPH or an authorized representative, with specified exemptions, and allows DPH access to those records.
- Permits DPH and any regional cancer registry designated by DPH to use the information to determine the sources of cancer and evaluate measures designed to eliminate, alleviate, or ameliorate its effect.
- Permits persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet certain qualifications as determined by DPH, and who agree in writing to maintain confidentiality to access confidential information.
- Authorizes contracting between state agencies and private contractors to furnish confidential information to other states’ cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect.
- Specifies that any disclosure of information include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed. Requires the individual to whom the information pertains to have access to his or her own information made available in the CCR.
This bill:
- Requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to DPH utilizing the College of American Pathologists cancer protocols or any other standardized format approved by DPH. Requires the reporting to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated Internet Web portal that DPH provides for pathologists’ use.
- Prohibits the reporting requirements from being interpreted to require a pathologist to submit the same report more than once, regardless of the format used.
- Allows a DPH authorized representative to access the information from the pathologist in an alternate format if a pathologist fails to report electronically and with an approved format. Requires a pathologist to reimburse DPH or the authorized representative for its cost to access and report the information.
- Provides that a pathologist is not responsible for acquiring missing or inaccessible patient demographic information not provided to him or her beyond the content of the required cancer-specific data elements.
- Requires DPH to prescribe the data required to be included in a report, work collaboratively with stakeholders to designate a standardized electronic format for submission, and designate an Internet Web portal for electronic submission.
Background
According to the DPH and American Cancer Society 2015 report, “California Cancer Facts and Figures,” cancer incidence rates have dropped 13% and death rates have declined 26% in California since 1988. Additionally, the overall incidence rate remains lower than the rest of the nation. Even with those declines, an estimated 172, 090 Californians will be diagnosed with cancer and 58,180 will die of the disease in 2015. The most commonly diagnosed cancers in men will be prostate, lung, and colorectal cancers, and breast, lung, and colorectal cancers will be the most frequently diagnosed among women.
In July of 2015, DPH announced participation in a pilot project with St. Joseph's Health System (St. Joseph’s) to better understand cancer trends in California. This partnership was the first of its kind in the United States in which a health system electronically collects and securely sends structured pathology cancer data directly to the CCR. According to DPH, this project has given the cancer registry the opportunity to perform real-time surveillance activities on data reported by project partners while opening the door to many new research opportunities that will ultimately improve patient treatment and outcomes. Ten hospitals within St. Joseph’s are now sending data directly to the CCR with other health care facilities expected to participate in the future. The St. Joseph pilot project is a collaboration between DPH, St. Joseph’s, mTuitive, a synoptic reporting system, and the College of American Pathologists (CAP). Prior to this project, a cancer diagnosis by a pathologist was only able to be stored as narrative text data within the hospital’s or laboratory’s electronic records system. The use of text data limited the practical uses of the pathology report for research into cancer causes and possible cures. Synoptic reporting is the use of structured checklists to produce standardized clinical documentation. For pathologists, this usually means using the CAP Cancer Protocols and electronic Cancer Checklists.
Issues with clinical trial participation. According to a document published by the Society for Women’s Health Research and the United States Food and Drug Administration Office of Women’s Health, “Dialogues on Diversifying Clinical Trials,” the most important diseases that disproportionately affect ethnic minorities include type 2 diabetes, cardiovascular disease, stroke, infectious diseases (HIV/AIDS, STDs), and different types of cancer (colon, prostate, cervix, and lung). Many racial health disparities stem from lack of access to quality health care and proper health awareness. Unfortunately this means that incidence of disease does not always match trial populations. For example, African Americans represent 12% of the U.S. population but only 5% of clinical trial participants. Hispanics make up 16% of the population but only 1% of clinical trial participants. Sex distribution in cardiovascular device trials is 67% male. According to the American Cancer Society Cancer Action Network, only approximately 3% of adults diagnosed with cancer participate in clinical trials, and the participation rate is lower for people who are racial and ethnic minorities, elderly, low-income, and live in rural areas.
The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified minority lack of disease education as a major barrier to recruitment. Other significant barriers to diversify enrollment, as reported by investigators and coordinators, are insurance status, patient inconvenience costs, availability of transportation, distance to the study site, and patient and family concerns about risk. However, race, age, and sex have been shown to play more significant roles in trial participation compared to proximity to trial location.
Comments
Author’s statement. According to the author, every cancer case diagnosed or treated in California is reported to the CCR. This vast repository of cancer data provides vital information to public health officers and researchers. With CCR data, it is possible to determine cancer risk factors and conduct early detection of cancer clusters. Although the CCR is a powerful tool, it is possible to use it in new and meaningful ways. Roadblocks to innovative uses of CCR data stem from long delays in cancer reporting. Under the current system, cancer diagnosis information is deposited in the CCR months, even years, after patient diagnosis. This long delay prevents rapid cancer research from taking place. AB 2325 will fix this issue by requiring pathologists who diagnose cancer to report diagnosis information electronically to the CCR. An additional barrier to innovative cancer research is low participation rates in cancer clinical trials. One of the major barriers to participation is simply lack of knowledge about available trials. AB 2325 will lift the burden of patients identifying trials and place it with researchers. After electronic reporting of cancer diagnosis information goes into effect, researchers will be able to request that information to identify potential matches to their own clinical trials.
Related/Prior Legislation
AB 2174 (Jones, 2016) would have required DPH, prior to researchers contacting a cancer patient, to ensure that a patient whose name appears in the CCR has received specified notice regarding the registry, including, among other things, that DPH is authorized to release confidential patient information to health researchers. AB 2174 was held under submission in the Assembly Appropriations Committee.
AB 1329 (Davis, Chapter 642, Statutes of 2011) required DPH to establish a process to receive applications for, and award a grant to, an agency to operate the CCR.
AB 48 (Cedillo, Chapter 368, Statutes of 2000) renamed the CCR the Ken Maddy California Cancer Registry, after the late state Senator Kenneth Maddy, former Minority Leader of the State Senate.
AB 136 (Connelly, Chapter 841, Statutes of 1985) established the CCR.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
American Cancer Society Action Network (co-source)
University of Southern California (co-source)
California Chronic Care Coalition
California Society of Pathologists
Stanford Health Care
OPPOSITION: (Verified 8/10/16)
None received
ARGUMENTS IN SUPPORT: Supporters argue that the current CCR system relies on a 30-year-old method that can take from six months to two years before information is fully reported. The CCR is recognized as one of the leading cancer registries in the world and has collected detailed information on more than 3.4 million cases of cancer among Californians diagnosed since 1988, and more than 162,000 new cases are added annually. Supporters state that this bill makes needed updates to the CCR to make it more efficient and effective and that through real-time reporting researching will be able to request diagnosis information to identify matches to ongoing cancer clinical trials. The California Society of Pathologists states that it has been engaged with DPH and the CCR to move to a standardized reporting format, which would greatly enhance the CCR’s mission.
ASSEMBLY FLOOR: 79-0, 5/5/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Beth Gaines
Prepared by: Reyes Diaz / HEALTH / (916) 651-4111
8/12/16 13:22:02
**** END ****
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB 2325 |
CONSENT
Bill No: AB 2325
Amended: 6/21/16 in Senate
SENATE HEALTH COMMITTEE: 7-0, 6/8/16
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth
NO VOTE RECORDED: Hall, Wolk
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 79-0, 5/5/16 (Consent) - See last page for vote
SUBJECT: Ken Maddy California Cancer Registry
SOURCE: American Cancer Society Action Network
University of Southern California
DIGEST: This bill requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to the Department of Public Health, as specified, for purposes of the Ken Maddy California Cancer Registry.
Existing law:
- Requires, pursuant to the Ken Maddy California Cancer Registry (CCR), the Department of Public Health (DPH) to conduct a program of epidemiological assessments of the incidence of cancer. Requires the program to encompass all areas of the state for which cancer incidence data are available, and to include monitoring of cancers associated with suspected carcinogens encountered by the general public both in occupational locations and in the environment.
- Authorizes the DPH Director to enter into contracts as necessary to conduct the CCR, and accept grants of public or private funds for the program on behalf of the state. Requires the Director to analyze available incidence data and prepare reports and perform studies as necessary to identify cancer hazards to the public health and their remedies.
- Requires any hospital or other facility providing therapy to cancer patients to report all cancers diagnosed or treated, in designated cancer reporting areas, to DPH or an authorized representative, and allows DPH access to those records. Requires specified health care providers diagnosing or providing treatment for cancer patients to report all cancers to DPH or an authorized representative, with specified exemptions, and allows DPH access to those records.
- Permits DPH and any regional cancer registry designated by DPH to use the information to determine the sources of cancer and evaluate measures designed to eliminate, alleviate, or ameliorate its effect.
- Permits persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet certain qualifications as determined by DPH, and who agree in writing to maintain confidentiality to access confidential information.
- Authorizes contracting between state agencies and private contractors to furnish confidential information to other states’ cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect.
- Specifies that any disclosure of information include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed. Requires the individual to whom the information pertains to have access to his or her own information made available in the CCR.
This bill:
- Requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to DPH utilizing the College of American Pathologists cancer protocols or any other standardized format approved by DPH. Requires the reporting to be by electronic means, either directly from an electronic medical record or using a designated Internet Web portal that DPH provides for pathologists’ use.
- Allows a DPH authorized representative to access the information from the pathologist in an alternate format if a pathologist fails to report electronically and with an approved format. Requires a pathologist to reimburse DPH or the authorized representative for its cost to access and report the information.
- Provides that a pathologist is not responsible for acquiring missing or inaccessible patient demographic information not provided to him or her beyond the content of the required cancer-specific data elements.
Requires DPH to prescribe the data required to be included in a report, work collaboratively with stakeholders to designate a standardized electronic format for submission, and designate an Internet Web portal for electronic submission.
Background
According to the DPH and American Cancer Society 2015 report, “California Cancer Facts and Figures,” cancer incidence rates have dropped 13% and death rates have declined 26% in California since 1988. Additionally, the overall incidence rate remains lower than the rest of the nation. Even with those declines, an estimated 172,090 Californians will be diagnosed with cancer and 58,180 will die of the disease in 2015. The most commonly diagnosed cancers in men will be prostate, lung, and colorectal cancers, and breast, lung, and colorectal cancers will be the most frequently diagnosed among women.
In July of 2015, DPH announced participation in a pilot project with St. Joseph's Health System (St. Joseph’s) to better understand cancer trends in California. This partnership was the first of its kind in the United States in which a health system electronically collects and securely sends structured pathology cancer data directly to the CCR. According to DPH, this project has given the cancer registry the opportunity to perform real-time surveillance activities on data reported by project partners while opening the door to many new research opportunities that will ultimately improve patient treatment and outcomes. Ten hospitals within St. Joseph’s are now sending data directly to the CCR with other health care facilities expected to participate in the future. The St. Joseph pilot project is a collaboration between DPH, St. Joseph’s, mTuitive, a synoptic reporting system, and the College of American Pathologists (CAP). Prior to this project, a cancer diagnosis by a pathologist was only able to be stored as narrative text data within the hospital’s or laboratory’s electronic records system. The use of text data limited the practical uses of the pathology report for research into cancer causes and possible cures. Synoptic reporting is the use of structured checklists to produce standardized clinical documentation. For pathologists, this usually means using the CAP Cancer Protocols and electronic Cancer Checklists.
Issues with clinical trial participation. According to a document published by the Society for Women’s Health Research and the United States Food and Drug Administration Office of Women’s Health, “Dialogues on Diversifying Clinical Trials,” the most important diseases that disproportionately affect ethnic minorities include type 2 diabetes, cardiovascular disease, stroke, infectious diseases (HIV/AIDS, STDs), and different types of cancer (colon, prostate, cervix, and lung). Many racial health disparities stem from lack of access to quality health care and proper health awareness. Unfortunately this means that incidence of disease does not always match trial populations. For example, African Americans represent 12% of the U.S. population but only 5% of clinical trial participants. Hispanics make up 16% of the population but only 1% of clinical trial participants. Sex distribution in cardiovascular device trials is 67% male. According to the American Cancer Society Cancer Action Network, only approximately 3% of adults diagnosed with cancer participate in clinical trials, and the participation rate is lower for people who are racial and ethnic minorities, elderly, low-income, and live in rural areas.
The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified minority lack of disease education as a major barrier to recruitment. Other significant barriers to diversify enrollment, as reported by investigators and coordinators, are insurance status, patient inconvenience costs, availability of transportation, distance to the study site, and patient and family concerns about risk. However, race, age, and sex have been shown to play more significant roles in trial participation compared to proximity to trial location.
Comments
Author’s statement. According to the author, every cancer case diagnosed or treated in California is reported to the CCR. This vast repository of cancer data provides vital information to public health officers and researchers. With CCR data, it is possible to determine cancer risk factors and conduct early detection of cancer clusters. Although the CCR is a powerful tool, it is possible to use it in new and meaningful ways. Roadblocks to innovative uses of CCR data stem from long delays in cancer reporting. Under the current system, cancer diagnosis information is deposited in the CCR months, even years, after patient diagnosis. This long delay prevents rapid cancer research from taking place. AB 2325 will fix this issue by requiring pathologists who diagnose cancer to report diagnosis information electronically to the CCR. An additional barrier to innovative cancer research is low participation rates in cancer clinical trials. One of the major barriers to participation is simply lack of knowledge about available trials. AB 2325 will lift the burden of patients identifying trials and place it with researchers. After electronic reporting of cancer diagnosis information goes into effect, researchers will be able to request that information to identify potential matches to their own clinical trials.
Related/Prior Legislation
AB 2174 (Jones, 2016) would have required DPH, prior to researchers contacting a cancer patient, to ensure that a patient whose name appears in the CCR has received specified notice regarding the registry, including, among other things, that DPH is authorized to release confidential patient information to health researchers. AB 2174 was held under submission in the Assembly Appropriations Committee.
AB 1329 (Davis, Chapter 642, Statutes of 2011) required DPH to establish a process to receive applications for, and award a grant to, an agency to operate the CCR.
AB 48 (Cedillo, Chapter 368, Statutes of 2000) renamed the CCR the Ken Maddy California Cancer Registry, after the late state Senator Kenneth Maddy, former Minority Leader of the State Senate.
AB 136 (Connelly, Chapter 841, Statutes of 1985) established the CCR.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
American Cancer Society Action Network (co-source)
University of Southern California (co-source)
California Chronic Care Coalition
California Society of Pathologists
Stanford Health Care
OPPOSITION: (Verified 6/28/16)
None received
ARGUMENTS IN SUPPORT: Supporters argue that the current CCR system relies on a 30-year-old method that can take from six months to two years before information is fully reported. The CCR is recognized as one of the leading cancer registries in the world and has collected detailed information on more than 3.4 million cases of cancer among Californians diagnosed since 1988, and more than 162,000 new cases are added annually. Supporters state that this bill makes needed updates to the CCR to make it more efficient and effective and that through real-time reporting researching will be able to request diagnosis information to identify matches to ongoing cancer clinical trials. The California Society of Pathologists states that it has been engaged with DPH and the CCR to move to a standardized reporting format, which would greatly enhance the CCR’s mission.
ASSEMBLY FLOOR: 79-0, 5/5/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Beth Gaines
Prepared by: Reyes Diaz / HEALTH / (916) 651-4111
6/29/16 15:50:46
**** END ****
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2325
AUTHOR: | Bonilla | ||
VERSION: | May 31, 2016 | ||
HEARING DATE: | June 8, 2016 | ||
CONSULTANT: | Reyes Diaz | ||
SUBJECT: Ken Maddy California Cancer Registry
SUMMARY:
Requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to the Department of Public Health, as specified, for purposes of the Ken Maddy California Cancer Registry.
Existing law:
- Pursuant to the Ken Maddy California Cancer Registry (CCR), requires the Department of Public Health (DPH) to conduct a program of epidemiological assessments of the incidence of cancer. Requires the program to encompass all areas of the state for which cancer incidence data are available, and to include monitoring of cancers associated with suspected carcinogens encountered by the general public both in occupational locations and in the environment.
- Authorizes the DPH Director to enter into contracts as necessary to conduct the CCR, and accept grants of public or private funds for the program on behalf of the state. Requires the Director to analyze available incidence data and prepare reports and perform studies as necessary to identify cancer hazards to the public health and their remedies.
- Requires any hospital or other facility providing therapy to cancer patients to report all cancers diagnosed or treated, in designated cancer reporting areas, to DPH or an authorized representative, and allows DPH access to those records. Requires specified health care providers diagnosing or providing treatment for cancer patients to report all cancers to DPH or an authorized representative, with specified exemptions, and allows DPH access to those records.
- Permits DPH and any regional cancer registry designated by DPH to use the information to determine the sources of cancer and evaluate measures designed to eliminate, alleviate, or ameliorate its effect.
- Permits persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet certain qualifications as determined by DPH, and who agree in writing to maintain confidentiality to access confidential information.
- Authorizes contracting between state agencies and private contractors to furnish confidential information to other states’ cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect.
- Specifies that any disclosure of information include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed. Requires the individual to whom the information pertains to have access to his or her own information made available in the CCR.
This bill:
- Requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses electronically to DPH utilizing the College of American Pathologists cancer protocols or any other standardized format approved by DPH.
- Allows a DPH authorized representative to access the information from the pathologist in an alternate format if a pathologist fails to report electronically and with an approved format. Requires a pathologist to reimburse DPH or the authorized representative for its cost to access and report the information.
- Provides that a pathologist is not responsible for acquiring missing or inaccessible patient demographic information not provided to him or her beyond the content of the required cancer-specific data elements.
- Requires DPH to prescribe the data required to be included in a report and work collaboratively with stakeholders to designate a standardized electronic format for submission.
FISCAL EFFECT:
According to the Assembly Appropriations Committee, since the business model of the CCR already incorporates a move to standardized electronic reporting and the CCR already has the technical capacity to conduct electronic data searches, costs are expected to be minor and absorbable (Proposition 99 funds).
PRIOR VOTES:
Assembly Floor: | 79 - 0 |
Assembly Appropriations Committee: | 19 - 0 |
Assembly Health Committee: | 16 - 0 |
COMMENTS:
- Author’s statement. According to the author, every cancer case diagnosed or treated in California is reported to the CCR. This vast repository of cancer data provides vital information to public health officers and researchers. With CCR data, it is possible to determine cancer risk factors and conduct early detection of cancer clusters. Although the CCR is a powerful tool, it is possible to use it in new and meaningful ways. Roadblocks to innovative uses of CCR data stem from long delays in cancer reporting. Under the current system, cancer diagnosis information is deposited in the CCR months even years after patient diagnosis. This long delay prevents rapid cancer research from taking place. AB 2325 will fix this issue by requiring pathologists who diagnose cancer to report diagnosis information electronically to the CCR. An additional barrier to innovative cancer research is low participation rates in cancer clinical trials. One of the major barriers to participation is simply lack of knowledge about available trials. AB 2325 will lift the burden of patients identifying trials and place it with researchers. After electronic reporting of cancer diagnosis information goes into effect, researchers will be able to request that information to identify potential matches to their own clinical trials.
- Background. According to the DPH and American Cancer Society 2015 report, “California Cancer Facts and Figures,” cancer incidence rates have dropped 13% and death rates have declined 26% in California since 1988. Additionally, the overall incidence rate remains lower than the rest of the nation. Even with those declines, an estimated 172, 090 Californians will be diagnosed with cancer and 58,180 will die of the disease in 2015. The most commonly diagnosed cancers in men will be prostate, lung, and colorectal cancers, and breast, lung, and colorectal cancers will be the most frequently diagnosed among women.
In July of 2015, DPH announced participation in a pilot project with St. Joseph's Health System (St. Joseph’s) to better understand cancer trends in California. This partnership was the first of its kind in the United States in which a health system electronically collects and securely sends structured pathology cancer data directly to the CCR. According to DPH, this project has given the cancer registry the opportunity to perform real-time surveillance activities on data reported by project partners while opening the door to many new research opportunities that will ultimately improve patient treatment and outcomes. Ten hospitals within St. Joseph’s are now sending data directly to the CCR with other health care facilities expected to participate in the future. The St. Joseph pilot project is a collaboration between DPH, St. Joseph’s, mTuitive, a synoptic reporting system, and the College of American Pathologists (CAP). Prior to this project, a cancer diagnosis by a pathologist was only able to be stored as narrative text data within the hospital’s or laboratory’s electronic records system. The use of text data limited the practical uses of the pathology report for research into cancer causes and possible cures. Synoptic reporting is the use of structured checklists to produce standardized clinical documentation. For pathologists, this usually means using the CAP Cancer Protocols and electronic Cancer Checklists.
- Issues with clinical trial participation. According to a document published by the Society for Women’s Health Research and United States Food and Drug Administration (FDA) Office of Women’s Health, “Dialogues on Diversifying Clinical Trials,” the most important diseases that disproportionately affect ethnic minorities include type 2 diabetes, cardiovascular disease, stroke, infectious diseases (HIV/AIDS, STDs), and different types of cancer (colon, prostate, cervix, and lung). Many racial health disparities stem from lack of access to quality health care and proper health awareness. Unfortunately this means that incidence of disease does not always match trial populations. For example, African Americans represent 12% of the U.S. population but only 5% of clinical trial participants. Hispanics make up 16% of the population but only 1% of clinical trial participants. Sex distribution in cardiovascular device trials is 67% male. According to the American Cancer Society Cancer Action Network, only approximately 3% of adults diagnosed with cancer participate in clinical trials, and the participation rate is lower for people who are racial and ethnic minorities, elderly, low-income, and live in rural areas.
The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified minority lack of disease education as a major barrier to recruitment. Other significant barriers to diversify enrollment, as reported by investigators and coordinators, are insurance status, patient inconvenience costs, availability of transportation, distance to the study site, and patient and family concerns about risk. However, race, age, and sex have been shown to play more significant roles in trial participation compared to proximity to trial location.
- Related legislation. AB 2174 (Jones), would have required DPH, prior to researchers contacting a cancer patient, to ensure that a patient whose name appears in the CCR has received specified notice regarding the registry, including, among other things, that DPH is authorized to release confidential patient information to health researchers. AB 2174 was held under submission in the Assembly Appropriations Committee.
- Prior legislation. AB 1329 (Davis, Chapter 642, Statutes of 2011), requires DPH to establish a process to receive applications for, and award a grant to, an agency to operate the CCR.
AB 48 (Cedillo, Chapter 368, Statutes of 2000), renamed the CCR the Ken Maddy California Cancer Registry, after the late state Senator Kenneth Maddy, former Minority Leader of the State Senate.
AB 136 (Connelly, Chapter 841, Statutes of 1985), established the CCR.
- Support. Supporters argue that the current CCR system relies on a 30-year-old method that can take from six months to two years before information is fully reported. The CCR is recognized as one of the leading cancer registries in the world and has collected detailed information on more than 3.4 million cases of cancer among Californians diagnosed since 1988, and more than 162,000 new cases are added annually. Supporters state that his bill makes needed updates to the CCR to make it more efficient and effective and that through real-time reporting researching will be able to request diagnosis information to identify matches to ongoing cancer clinical trials. The California Society of Pathologists states that it has been engaged with DPH and the CCR to move to a standardized reporting format, which would greatly enhance the CCR’s mission.
SUPPORT AND OPPOSITION:
Support: American Cancer Society Action Network (co-sponsor)
University of Southern California (co-sponsor)
California Chronic Care Coalition
California Society of Pathologists
Stanford Health Care
Oppose: None received
-- END --
Date of Hearing: April 27, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
ABPCA Bill Id:AB 2325
Author:(Bonilla) – As Amended Ver:April 5, 2016
Policy Committee: | Health | Vote: | 16 - 0 |
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to the California Cancer Registry (CCR) of the California Department of Public Health (CDPH) in a format prescribed by CDPH, and establishes a pilot project to enable CDPH and authorized users to conduct electronic specific data element searches of the information collected by the registry.
FISCAL EFFECT:
As the business model of the CCR already incorporates a move to standardized electronic reporting and the CCR already has the technical capacity to conduct electronic data searches, costs are expected to be minor and absorbable (Proposition 99 funds).
COMMENTS:
- Purpose. This bill will allow the CCR to be used by researchers in order to find patients who may benefit from clinical trials, and will make reporting to the registry more rapid by requiring electronic reporting by pathologists who diagnose cancer. This bill is co-sponsored by the American Cancer Society Action Network and the University of Southern California.
- Background. The CCR is a statewide, population-based cancer surveillance system that monitors the incidence of mortality of specific cancer over time, and analyzes differential risks of cancer by race/ethnicity, age, sex, geographic region, and other social characteristics of the population. The CCR conducts research and collaborates with researchers on cancer research projects related to treatment, risk factors, and prevention of cancer. This bill is expected to modernize and improve the utility of the CCR.
- Related Legislation. AB 1823 (Bonilla), also being heard today, requests the UC to establish a grant program to increase participation in clinical trials, as specified.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
ABPCA Bill Id:AB 2325
Author:(Bonilla) – As Amended Ver:April 5, 2016
SUBJECT: Ken Maddy California Cancer Registry.
SUMMARY: Requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to the Department of Public Health (DPH) in a format prescribed by DPH and establishes a pilot project to enable DPH and authorized users to conduct electronic specific data element searches of the information collected by the Ken Maddy California Cancer Registry (CCR). Specifically, this bill:
- Requires, on or after January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to DPH in a format prescribed by DPH.
- Permits an authorized representative of DPH to access the information from a pathologist if a pathologist fails to report in the appropriate format.
- Requires, if an authorized representative of DPH has to access information from a pathologist, the pathologist to reimburse DPH or the authorized representative for its cost to access and report the information.
- Requires DPH to prescribe the data required to be included in the report and designated a standardized electronic format for submission.
- Requires DPH to establish a pilot project to enable DPH and authorized users to conduct electronic specific data element searches of the information collected by the registry for the purpose of identifying individuals who meet cancer clinical trial eligibility requirements.
EXISTING LAW:
- Requires DPH to conduct a program of epidemiological assessments of the incidence of cancer. Requires the program to encompass all areas of the state for which cancer incidence data are available, and to include monitoring of cancers associated with suspected carcinogens encountered by the general public both in occupational locations and in the environment.
- Allows DPH to contract with an agency, including, but not limited to a health systems agency, single or multiple county health departments, or nonprofit professional associations, representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data.
- Requires the Director of DPH (Director) to establish the CCR, a statewide system to collect information on the incidence of cancer using population-based cancer registries. Requires these registries to be implemented or initiated by July 1, 1988, and requires that the statewide cancer reporting system be fully operational by July 1, 1990.
- Authorizes the Director to enter into contracts as necessary to conduct the program, and accept grants of public or private funds for the program on behalf of the state. Requires the Director to analyze available incidence data and prepare reports and perform studies as necessary to identify cancer hazards to the public health and their remedies.
- Mandates the Director to require the reporting of cancer to DPH, or its authorized representative, in areas of the state where cancer information is being collected.
- Requires any hospital or other facility providing therapy to cancer patients to report all cancers diagnosed or treated, in designated cancer reporting areas, to DPH or an authorized representative, and allows DPH access to those records.
- Requires specified health care providers diagnosing or providing treatment for cancer patients to report all cancers to DPH or an authorized representative, with specified exemptions, and allows DPH access to those records.
- Authorizes DPH to fine entities that do not comply with these record-sharing requirements, and requires that fines collected be deposited into the General Fund.
- Requires all information collected for the purpose of the CCR to be kept confidential.
- Permits DPH and any regional cancer registry designated by DPH to use the information to determine the sources of cancer and evaluate measures designed to eliminate, alleviate, or ameliorate its effect.
- Permits persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet certain qualifications as determined by DPH, and who agree, in writing, to maintain confidentiality, to access confidential information.
- Authorizes contracting between state agencies and private contractors to furnish confidential information to other states’ cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect.
- Requires, prior to confidential information being disclosed to designated entities, those designated entities to agree in writing to maintain the confidentiality of the information, and requires researchers to do both of the following:
- Obtain approval of their committee for the protection of human subjects in accordance with federal regulations; and,
- Provide documentation to DPH that demonstrates that the entity has established appropriate procedures and its ability to maintain the confidentiality of the information.
- Specifies that any disclosure of information include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
- Requires DPH to maintain an accurate record of all persons who are given access to confidential information in the CCR including:
- The name of the person authorizing access;
- Name, title, address, and organizational affiliation of persons given access;
- Dates of access; and,
- The specific purpose for which information is to be used.
- Requires records of those who access the CCR, pursuant to 15) above, to be open to public inspection.
- Requires the individual to whom the information pertains to have access to his or her own information made available in the CCR.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.
COMMENTS:
- PURPOSE OF THIS BILL. According to the author, this bill creates an innovative, new tool which will allow researchers working on clinical trials to reach out to patients to provide them the opportunity to participate in cutting edge treatments. This bill removes the burden of searching for a cancer clinical trial from patients who are battling cancer and places it on the clinician. The author states that roadblocks to innovative uses of the CCR data stem from long delays in cancer reporting. At best, cancer diagnosis information is reported to the CCR within six to nine months after diagnosis. In reality, it could take one to two years before information is fully reported.
Modernization of the CCR, through electronic pathology reporting, will significantly increase the speed at which diagnosis reports are deposited within the CCR. Because of the real-time reporting, researchers will be able to request diagnosis information to identify matches to ongoing cancer clinical trials. As a result, trial participants will be identified much faster with no burden on cancer patients. Due to the rapid matching of patients to trials and increased participation, cancer therapies will be developed and improved much faster than currently possible because patients will be connected to potentially lifesaving treatments.
- BACKGROUND. According to the DPH and the American Cancer Society 2015 report of California Cancer Facts and Figures, figures show that cancer incidence rates have dropped 13% and death rates have declined 26% in California since 1988. Additionally, the overall incidence rate remains lower than the rest of the nation. Even with those declines, an estimated 172, 090 Californians will be diagnosed with cancer and 58,180 will die of the disease in 2015. The most commonly diagnosed cancers in men will be prostate, lung and colorectal cancers and breast, lung and colorectal cancers will be the most frequently diagnosed among women.
- University of Southern California (USC) Cancer Registry Program. The Los Angeles County Cancer Surveillance Program (CSP) is the population-based cancer registry for Los Angeles County. It identifies and obtains information on all new cancer diagnoses made among residents of Los Angeles County. The CSP was established in 1970 and operates within the administrative structure of the USC School of Medicine. It was developed with the voluntary cooperation of hospitals and other institutions, clinics, and medical laboratories equipped to diagnose cancer in Los Angeles County. By 1972, the CSP became population-based and complete incidence data for Los Angeles County were made available from that year onward. To date, the CSP master file contains over 1.7 million records and about 41,000 incident cancers are added annually.
Since 1981, the CSP has been the designated legal agent of Los Angeles County for collecting information on all new cancer cases occurring among County residents for the purpose of monitoring cancer incidence patterns and trends. In 1987, it became the regional registry for Los Angeles County for the new California Cancer Registry. The CSP is one of eight such regional registries providing, as a group, statewide coverage. In September 1992, the CSP became the largest registry of the National Cancer Institute-funded Surveillance, Epidemiology, and End Results (SEER) program. The consortium of 18 population-based SEER registries provides the federal government with a “snapshot” of cancer incidence and survival across the United States.
- DPH Pilot Program. In July of 2015, DPH announced participation in a pilot project with St. Joseph's Health System (St. Joseph) to better understand cancer trends in California. This partnership is the first in the United States in which a health system electronically collects and securely sends structured pathology cancer data directly to the CCR. According to DPH, this project has given the cancer registry the opportunity to perform real-time surveillance activities on data reported by project partners while opening the door to many new research opportunities that will ultimately improve patient treatment and outcomes. Work on this pilot program began in January 2014. The first complete data-set was sent by St. Joseph’s to CCR in March 2015.
Ten hospitals within St. Joseph’s are now sending data directly to the CCR with other health care facilities expected to participate in the future. The St. Joseph pilot project is a collaboration between DPH, St Joseph, mTuitive, a synoptic reporting system, and the College of American Pathologists (CAP). Prior to this project, a cancer diagnosis by a pathologist was only able to be stored as narrative text data within the hospital’s or laboratory’s electronic records system. The use of text data limited the practical uses of the pathology report for research into cancer causes and possible cures. Synoptic reporting is the use of structured checklists to produce standardized clinical documentation. For pathologists, this usually means using the CAP Cancer Protocols and electronic Cancer Checklists.
- Barriers to Trial Participation. The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified a number of reasons that are major barriers to minority recruitment in clinical trials. There are many different factors that have been attributed, in part, to the very low participation rate of all eligible patients in clinical trials, and the disproportionately low participation rate of minority populations including, but not limited to:
- Lack of awareness: A national survey of cancer patients found that 85% of respondents were unaware that participating in a clinical trial was a treatment option for them.
- Language/Linguistic differences: Many U.S. clinical trials require English proficiency for potential participants, automatically excluding those who do not speak the language. Language factors also pose a serious barrier to provider-patient communications and attempts to recruit patients into clinical trials.
- Mistrust: According to a review conducted by the Agency for Healthcare Research and Quality, mistrust of research and the medical system is a frequently reported barrier to participating in clinical trials.
- Practical obstacles: Transportation to and from a trial, particularly if it is located in a distant location, can be a barrier for many patients. Individuals with low incomes may find it difficult to take time off from work, find childcare or manage other family responsibilities while participating in a trial.
- Public misconception: Among patients that are aware of clinical trials, a large percentage choose not to enroll, often due to fear of getting a placebo in place of actual treatment, belief that standard treatment is better than what they would be offered in a clinical trial and fear of being a "guinea pig." However, placebos are rarely used in cancer treatment trials, and never in lieu of standard treatment.
- Physician lack of awareness: Being unaware that clinical trials are available is one of the most common reasons physicians fail to refer patients to trials. Primary care physicians do not have sufficient information on available clinical trials, and often leave the discussion of clinical research to the patient’s oncologist. Yet, many oncologists outside of the academic setting may also not be aware of trials or otherwise choose not to participate in or refer their eligible patients to clinical trials.
- Barriers to Trial Participation. The Coalition to Eliminate Disparities and to Research Inclusion in Clinical Trials identified a number of reasons that are major barriers to minority recruitment in clinical trials. There are many different factors that have been attributed, in part, to the very low participation rate of all eligible patients in clinical trials, and the disproportionately low participation rate of minority populations including, but not limited to:
- Federal Efforts to Increase Women and Minority Participation. The federal Food and Drug Administration (FDA) Office of Women’s Health (OWH) was established by congressional mandate to advocate for the participation of women in clinical trials and the analyses of data by sex. OWH supports studies to track the participation of women in clinical trials and collaborates with the FDA and external partners to understand sex and gender differences in disease prevalence and response to therapy through science and research. The FDA Office of Minority Health (Office) is housed within the Office of the Commissioner and is the principal advisor on minority health and health disparities. The Office is responsible for coordinating efforts throughout the FDA and has focused its efforts on three key areas: communicating and disseminating agency information to vulnerable populations; increasing participation of diverse health professionals in FDA activities to strengthen its capacity to address health disparities; and, advocating for meaningful participation of minorities in clinical trials as well as the analysis of subpopulation data.
According to a 2011 report titled "Successful Strategies for Engaging Women and Minorities in Clinical Trials," the National Institutes of Health funded studies have specific diversity requirements, but aside from FDA recommendations, there are no regulations currently in place that require industry sponsors to include women and minorities in their trials. Diversity is not a natural priority for industry, where decisions often are made by market attractiveness and potential profit.
- SUPPORT. USC, a cosponsor of the bill, states that although the CCR is a powerful tool, currently available technologies would allow it to do so faster and more efficiently. Roadblocks to innovative uses of the CCR data stem from long delays in cancer reporting due to reliance on 30 year old methods. At best, cancer diagnosis information is reported to the CCR within six to nine months after diagnosis. In reality, it can take one to two years before that information is fully reported. The long reporting times occur because of inefficient data collection methods. USC argues that this measure will ensure that rapid, real-time electronic cancer diagnosis reporting becomes standard in California, providing higher quality data and allowing new uses of the CCR. For nearly all new cancer diagnoses, the pathology report is the first available record and virtually all are prepared electronically. Yet, pathology reports are not prepared, stored or accessed in a consistent method.
USC states that modernization of the CCR, through electronic pathology reporting, will significantly increase the speed at which diagnosis reports are available within the CCR. Public health officials, researchers and medical providers will be able to monitor cancer occurrence months to years earlier than currently possible and the public will be reassured that the identification of possible new risks will occur as early as possible. USC concludes that this measure will significantly enhance cancer research and monitoring in California through modernization of the CCR.
- RELATED LEGISLATION. AB 2174 (Jones) would requires, prior to researchers contacting a cancer patient, DPH to ensure that a patient whose name appears in the CCR has received specified notice regarding the registry including, among other things, that DPH is authorized to release confidential patient information to health researchers. This bill is pending in the Assembly Health Committee.
- PREVIOUS LEGISLATION.
- AB 1329 (Davis), Chapter 642, Statutes of 2011, requires DPH to establish a process to receive applications for, and award a grant to, an agency to operate the CCR.
- AB 48 (Cedillo), Chapter 368, Statutes of 2000, renames the California Cancer Registry to the Ken Maddy California Cancer Registry, after the late state Senator Kenneth Maddy, former Minority Leader of the State Senate.
- AB 136 (Connelly), Chapter 841, Statutes of 1985, established the California Cancer Registry.
REGISTERED SUPPORT / OPPOSITION:
Support
American Cancer Society Cancer Action Network
California Society of Pathologists
University of Southern California
Opposition
None on file.
Analysis Prepared by: Paula Villescaz / HEALTH / (916) 319-2097
Discussed in Hearing
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Bill Author
Bill Co-Author(s):