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California State Assembly Bill (AB) 2325

Per AB 2325, signed by Governor Jerry Brown on September 14, 2016, pathologists diagnosing cancer are to report cancer diagnosis to the California Cancer Registry (CCR) electronically by January 1, 2019. Defined reporting requirements and a standardized format for reporting pathology cancer diagnosis is outlined in the CCR Electronic Pathology Reporting Standards Implementation Guide. Pathologists and pathology software providers will need to review the Implementation Guide and register with the CCR to meet California reporting requirements. A pathologist or pathology lab will be able to satisfy reporting compliance by adhering to the reporting requirements and standardized format regardless of the technical platform used to capture, store and submit data.

 

To Download a Copy of the Implementation Guide Click on the Link Below:

California Electronic Pathology Reporting - Associated Links

To Download Please Click on the Links Below:

To view the full AB 2325 Bill click here

 

Factsheets Now Avaliable!

Have a Question Regarding AB 2325 Ask it Now!

To submit your question please email us at AB2325Help@cdph.ca.gov

 

How has AB 2325 Changed Cancer Reporting in California?

AB 2325 includes five new articles within Section 103885 of the California Health and Safety Code.

  • (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 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 department’s authorized representative may access the information from the pathologist in an appropriate alternative format. In these cases, thepathologist 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.
Top Four Q & A Regarding AB 2325
  1. Will use of the College of American (CAP) Electronic Cancer Checklists (eCC) be a requirement for pathologists to use to meet the CA reporting mandate?
    No, CAP eCC is not a requirement of the state to meet the California pathology reporting requirement. However, use of software which supports discrete data capture, such as CAP eCC, is highly encouraged in order for CCR to efficiently process cancer incidence data and achieve future uses of data envisioned by CCR.
  2. If my pathology department or lab already reports to CCR, will the requirements for reporting change?
    Reporting requirement are detailed within the Pathology Electronic Reporting Implementation Guide. Pathology departments and laboratories currently reporting to CCR should reference the Implementation Guide and plan for any necessary changes accordingly. Pathology laboratories reporting via current nationally approved methods via either the National Lab Reporting Project (CDC/NPCR) or the National Cancer Institute (NCI) Surveillance and Epidemiology for End Results (SEER) program supported by Artificial Intelligence in Medicine (AIM) will not require a change to their current reporting configuration. However, it is the intent of CCR to collect and obtain the highest standard of data available from pathologists and laboratories. If a laboratory can meet a higher level of the reporting standard as outlined in the implementation guide, CCR would like to work with the laboratory to explore obtains of obtaining a higher level standard of data.
  3. If my pathology department or lab already reporting to CCR, should reporting be discontinued until the new reporting requirements are defined and the Implementation Guide is released?
    No, CCR will continue to accept pathology reports in their current form from current sources. Pathology departments and labs should plan to review the Implementation Guide, implement any new changes per defined reporting requirements, and work with CCR to meet the legislative reporting mandate for pathology reporting by January 1, 2019.
  4. If my pathology department or lab does not currently report to CCR, when is the new legislation effective?
    The legislation for pathologists to report becomes effective as of January 1, 2019. Pathologists, pathology departments, pathology labs and pathology software vendors should plan accordingly to comply with California reporting requirements and begin to submit data to CCR on or before January 1, 2019.
October 2017 Q & A Regarding AB 2325
  1. When will the Direct Data Entry Web Portal be available?
    The Direct Data Entry Web Portal will be available by January 1, 2019 in alignment with the mandate for pathologists to comply with the electronic reporting legislation.
  2. When will the Self-Testing Portal be available?
    The Self-Testing Portal has been planned to be available in January 2018.
  3. Will the CCR be working with San Diego Health Connect (HIE) to establish electronic connectivity?
    My understanding from SDHC is that connectivity with the CCR is due for (mid) 2018. We currently utilize SDHC for sending lab reportable results to Public Health. Would it be advisable to wait or move forward with direct interface to CCR?
    Answer: CCR is in discussions with SDHC to establish a connectivity profile. As SDHC has stated, the profile if approved by the CA Department of Public Health, is planned to be available to the SDHC community in the April/May/June timeframe of 2018. All facilities should proceed with the registration process at the current time. When selecting the “Data Submission Method” at the bottom of the registration page, select “Electronic Interface” and “SOAP Web Service”. Indicate in the Vendor Information section that your preference would be to leverage a data exchange profile within SDHC.
  4. I have a customer asking if we can develop the LIS side of the interface to support sending of multiple California Cancer Registry facility IDs. Are the Registry ID’s the same as the lab’s unique Clinical Laboratory Improvement Amendments (CLIA) identifier I see referenced in the Standards Draft?
    Yes, CCR uses the CLIA’s to identify the sending facilities. CCR does map to an internal registry ID, but all lab reports enter our system and are validated by the CLIA.
  5. Should we register now or wait until the self-testing portal is available?
    Register now…..begin working now with your software vendor to set up data submission testing when the self-testing portal goes live. Software vendors can reference to the CA Implementation Guide.
  6. Can we upload a list of pathologist to the registration portal or do they need to be added manually?
    There currently is not a way to upload a list of names. It is a one-time process upon registration; CCR will not be asking facilities to update represented pathologists with changes at this point in time.
September 2017 Q & A Regarding AB 2325
  1. When will the Reporting registration open on line?
    The Reporting Registration is now available it went live on September 29, 2017.
  2. We already use CNExT to abstract and report our cases to the State-will we require additional software?
    Yes, you will need to work with your Laboratory Information System software vendor and additional software may be needed in order to submit cancer pathology reports
    Cancer Case Abstract Reporting is a different data source, CNExT is a cancer case abstracting software product that is used primarily by hospital based registries to create and submit full cancer case abstracts to CCR
    Please review the CCR Electronic Pathology Reporting Standards Implementation Guide for more information and talk to your LIS vendor and IT department.
  3. Is there a start-up fee?
    No, the state of California does not charge a start-up fee. The CCR Electronic Pathology Reporting Standard Implementation Guide was developed by the CA Department of Public Health and is a free resource for pathologists and pathology software vendors. Please check with your software vendor.
  4. Will there be a maintenance fee?
    No, the state of California does not charge a maintenance fee.
  5. Do you have a copy of (AB)2325?
    Yes, please click on this link (http://www.ccrcal.org/pdf/AB2325/20150AB2325_93.pdf) to download a copy of the legislation AB 2325
  6. Will it be necessary to hire additional staff to meet this requirement?
    If you currently do not have an output of cancer data being routed to CCR, a facility will need to work with their LIS software vendor to configure the output. If a facility does not want to configure an electronic output from their LIS, an openly available CCR Web Reporting Portal will be available on or before January 1, 2019. The CCR Web Reporting Portal will require manual data entry of pathology cancer case information and subsequently will require manual staff time to enter the appropriate case data.
  7. What is the penalty for non-compliance?
    Please see the AB 2325 legislation to download a copy click on this link (http://www.ccrcal.org/pdf/AB2325/20150AB2325_93.pdf)
  8. Do you have any printed brochures for distribution explaining AB2325 Electronic Pathology Reporting to the CCR?
    Yes, we developed an At-A-Glance factsheet for AB2325 to download a copy and also access more information please visit our website at http://www.ccrcal.org/AB2325.shtml.

 

Timeline AB 2325

  • September 14, 2016: AB2325 signed by Governor Jerry Brown.
  • July 31, 2017: Release of CCR Implementation Guide.
  • September 2017: Reporting registration open.
  • January 31, 2017: Self-Testing Portal Open.
  • July 1, 2018: Pathology Laboratory Registration Deadline.
  • July 31, 2018: Pathology Direct Data Entry Web Portal Available.
  • January 1, 2019: Data submission to the CCR must be established by pathologists and pathology labs.