Procedures Protocols and Forms for the Release of Data

Procedures, Protocols and Forms for the Release of Data from the Tennessee Cancer Registry Tennessee Department of Health, Office of Policy, Planning & Assessment, Tennessee Cancer Registry Revised 05/2008 Table of Contents Preface…………………………………………………………………………. I. Procedures and Protocols for the Release of Tennessee Cancer Registry Data A. Introduction………………………………………………………………………………… B. Principles……………………………………………………………………………………. C. Data Release Protocol………………………………………………………………………. 1. Data Classification……………………………………………………………………….. 4 5 5 6 6 a. Aggregate Data i. Unrestricted ii. Restricted b. Individual-Level Data i. Potentially Identifiable Data ii. Identifiable Data 2. Data Release Guidelines…………………………………………………………………. 7 a. External i. Research Requests ii. Data Sharing Contracts iii. Governmental and Related Agency Data Requests Policy b. Internal -Tennessee Department of Health Data Requests 3. Data Security …………………………………………………………………………….. a. Confidentiality Policy & Agreement 9 b. Data Access Review Committee II. Data Request Flowchart………………………………………………………… III. Aggregate Data Aggregate Data Release Policy………………………………………………………………… Aggregate Data Request Form………………………………………………………………… 10 11 13 IV. Individual-Level Data Individual-Level Data Request Policy…………………………………………………………. Individual-Level Data Request Form………………………………………………………….. Confidentiality Agreement…………………………………………………………………….. 16 18 25 V. Governmental and Related Agency Data Request Policy Within the Tennessee Department of Health, Other State Agencies, Data Sharing No Cost Contracts, other State Cancer Registries, U.S. Federal Agencies and Individual Policy…………………………………………………………………………………... Request for Data Form (PH-3599 Rev. 7-03)…………………………………………. 27 28 VI. Appendix Data Access Review Committee Member List………………………………………... Data Access Review Committee Guidelines ………………………………………….. Data Access Review Committee Summary Report……………………………………. Request for Individual-Level Data Procedure Outline ………………………………... Reference Guidelines …………………………………………………………………. Tennessee Code for Cancer Reporting Systems (T.C.A. 68-1-1001)…………………. Tennessee Cancer Registry Reporting Rules (Chapter 1200-7-2)…………………….. Dictionary of Terms…………………………………………………………………… 31 32 33 34 35 36 41 47 Preface The Tennessee Cancer Registry (TCR) was established in 1983 by the Tennessee Department of Health (TDOH) in response to a state law, T.C.A. 68-1-1001 (See Appendix, page 36), that made cancer a reportable condition. This law requires hospitals, laboratories, Ambulatory Surgery Centers, and other facilities to report to the Tennessee Department of Health information on patients diagnosed and/or treated for cancer in the state. The TCR of the TDOH follows the Cancer Reporting System Rules Chapter 12007-2 (see page 41). These rules provide for the implementation of the Tennessee Cancer Reporting System Act of 1983 and its amendments. In May, 2000, the Tennessee Legislature amended this law broadening its scope by expanding the number of reporting sources, allowing access to medical records in the event data is not reported, and providing for the interstate exchange of data. In 1992, the 102 Congress passed Public Law 102-515 which allows states to receive federal grants to support population-based, statewide cancer registries. The TCR has received federal funding from the Centers of Disease Control and Prevention (CDC) through the National Program of Cancer Registries (NPCR) since 1999. The TCR has endeavored to collect comprehensive, timely, and accurate information on all cancer patients diagnosed and/or treated in the state. Because this information includes demographic information, stage at diagnosis, first course of treatment, and deaths due to cancer, it is a valuable tool in the evaluation of progress towards cancer prevention and control. The mission statement of the TCR is “dedication to the collection and use of quality data for the purpose of decreasing the incidence and mortality of cancer in Tennessee”. One goal of the TCR is to make available the cancer data that has been collected for research purposes. The TCR is responsible for protecting the confidentiality of patients' data reported to the TCR. This document describes the policies, procedures and relevant forms that the TCR uses to balance the need to protect confidential cancer data with the legislatively mandated requirement that data shall be released for valid research purposes to further the prevention, control and treatment of cancer in the state of Tennessee. 4 State of Tennessee Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor North 425 Fifth Avenue North Nashville, TN 37243 Procedures and Protocols for the Release of Tennessee Cancer Registry Data A. Introduction The Tennessee Department of Health (TDOH) and the Tennessee Cancer Registry (TCR) maintain that an effective cancer control program requires a policy of information access that supports the efforts of the scientific, educational and medical communities serving the citizens of Tennessee. The Tennessee Cancer Reporting System Act of 1983 established procedures for the centralized collection of cancer incidence data, as well as a mandate for the dissemination of data. Data reported from hospitals are stored and maintained in a central registry. These data contain various personal identifiers such as patient name, address, date of birth, as well as diagnosis and treatment data. Due to the sensitive nature of these data, measures must be taken to ensure the confidentiality and integrity of the data. The following guidelines for data requests have been developed with these goals in mind. B. Principles Because the right to privacy is of utmost importance, the confidentiality of persons diagnosed with cancer and reported to the TCR will be the primary concern. The release of data, either individual-level or aggregate, will be approved only when the protocols and procedures described in this document have been met. A flowchart outlining the data request process is attached (see page 10) Because the data collected are of value to public health research and medical practice, the policy of the TCR will be to make decisions regarding release of information in favor of access. However, access will be subject to the limitations concerning confidentiality, security, and the prevention of potential misuse. The TCR believes that cancer registry data can and should inform cancer control and prevention activities by describing and analyzing demographic and disease trends, as well as by identifying geographic clusters of disease. The primary goals of these control and prevention activities are to identify specific groups at higher risk of cancer, increase survival rates, improve patient care, and to identify, quantify, and respond to cancer clusters. 5 C. Data Release Protocol In the interest of balancing the principles of data access and patient confidentiality, the TCR has classified the release of data collected. These classifications are designed to promote the use of accurate cancer incidence data, expedite the data release process, and encourage the distribution of a wide array of data elements without compromising confidentiality. The two classifications of data requests described here are aggregate data (containing no personal identifiers) and individual-level data (which may or may not contain personal identifiers). Data requests fall into two categories, internal or external. Internal data request category consists of requests from within the TDOH. The external category refers to all other data requests received. 1. Data Classification a. Aggregate Data Standardized annual reports will be made available that include a comprehensive summary of cancer incidence in Tennessee. These reports will include frequency distributions of cancer cases by primary site, histologic type, stage/behavior, as well as gender, race and standardized age groups. The reports will provide incidence rates, as well as direct age-adjusted rates, tabulated by gender, primary site and various geographic units (state, county, health department regions, etc.). Various tables, graphs and maps will also be included. These reports will be available both in print and on the TDOH website (http://www2.state.tn.us/health/TCR/index.htm). Data not available in these reports will be made available based on the following guidelines: i. Unrestricted All requests for aggregate data must be submitted to the TCR in writing (see page 11). Aggregate data NOT provided in the TCR’s Annual Report will be released after the written request has been reviewed in accordance with the following guidelines: ¾ No data that directly or indirectly identifies cancer patients will be provided. ¾ Data will be considered to have a reasonable possibility of indirectly identifying cancer patients if it includes any of the following: • Rates, cross-tabulations or frequencies that are based on five or fewer cases for any one site of cancer • Rates, cross-tabulations or frequencies over any time period that are based on five or fewer cases for any one demographic or geographic unit. In an effort to prevent the identification of individual patients from aggregate data broken down by demographic and geographic units, counts and rates will be suppressed when fewer than six (6) cases are recorded in any given category. For reasons of rate stability, rates based on fewer than sixteen (16) cases will also be suppressed. These suppression guidelines are based on CDC standards and policies used by other state registries. Maps created with geocoded data must adhere to the data suppression rules. 6 ii. Restricted TCR staff must review and give prior approval for requests for aggregate data that include the release of frequencies based on fewer than six (6) cases and rates based on fewer than sixteen (16) cases. These data may be released for research purposes only and shall be presented/published in accordance with TCR guidance. b. Individual-Level Data All data requests for individual-level data must be submitted to the TCR in writing (see page 16). Individual-level data will be released only after the written application (see page 18) has been reviewed and the conditions described below have been satisfied. Two types of requests for individuallevel data will be considered: i. Potentially Identifiable data: Non-identifiable data, or individual-level data stripped of all personal identifiers (e.g. name, address, date of birth, data element combinations that have a reasonable possibility of indirectly identifying cancer patients). ii. Identifiable Data: Identifiable data, or individual-level data containing personal identifiers for use in follow-up studies, or any studies that require contacting patients or clinicians to obtain additional information. 2. Data Release Guidelines: a. External i. Research Requests: The TCR is prepared to provide data to outside researchers on a variety of approved cancer research projects. However, before data are released all research proposals requesting the use of individual-level data from the TCR must be in compliance with the following criteria: • • • • The proposed research will be used to determine the course of cancer among residents of Tennessee or to reduce the burden of cancer in Tennessee. The data requested are necessary for the efficient conduct of the study. Adequate protections are in place to insure data security, including usage, access and storage. Adequate assurance has been provided that data will only be used for the purposes of the study described in the proposal, and any confidential data will either be returned or destroyed following completion of the research project. The proposal has been reviewed and approved by an Institutional Review Board (IRB) formed in accordance with the provisions of the U.S. Department of Health and Human Services Code of Federal • 7 • • • Regulations Title 45, Part 46, Protection of Human Subjects (revised November 13, 2001). TDOH IRB approval is required for research involving contact with the patient or the patient’s family. The request includes a comprehensive protocol containing a description of the study, the principal investigator’s qualifications and affiliation(s), study background, research questions, study design, case definition and selection (where applicable), control definition and selection (where applicable), informed consent and confidentiality procedures and documentation, project resources, and data analysis plan. The request includes a statement identifying the benefits of the study for the residents of Tennessee. Completion of application and signed consent form. Investigators should be advised that meeting the requirements listed above does not guarantee access to the data requested, only that the request will be given appropriate consideration by the TCR’s Data Access Review Committee (DARC). Furthermore, the committee retains the right to impose additional conditions or reporting requirements in order to insure that the research is conducted in an appropriate manner. ii. Data Sharing Contracts Metropolitan Regional Health Departments within Tennessee, as well as other Tennessee state government and county agencies and universities, may establish data sharing contracts with the TDOH. These contracts allow for the timely release of requested data. Agencies contracting with TDOH must complete a data request form (aggregate or individual-level) before receiving data. If individual-level data is requested, the DARC must approve the data request before the data can be released. Information regarding the study design, methods, and dissemination of findings must be provided. A confidentiality agreement must also be signed for individual-level data requests. The requesting parties remain bound by the data release guidelines outlined above, as well as other specifications in their data sharing contracts. iii. Other Tennessee State Agencies, other State Cancer Registries, U.S. Federal Agencies Data Requests and Individuals All data requests from other departments within the State of Tennessee or other state agencies must be submitted using a data request form (aggregate or individual-level). If individual-level data is requested, the data request form must be reviewed and approved by the DARC before the data will be released. Requests will follow the policies outlined in the flowchart on page 10. A confidentiality agreement form must also be completed for any individual-level data request. Occasionally faxes are received from the United States Department of Labor requesting information on a specific person. These claim forms are for the Survivor Benefits under the Energy Employees Occupational Illness Compensation Program Act. The signed survivor declaration is sufficient for release of information concerning the decedent who might be in the TCR database. 8 Requests from other federal agencies for TCR information will be processed on a case by case basis, but will generally follow the guidelines presented in this policy. Requests received from other State Cancer Registries will complete the Request for Data form (PH-3599 Rev. 7-03) beginning on page 28. If an individual requests their own information, the request must be submitted in writing using the data request form PH-3599 Rev. 7-03 (see page 28). Identification of the individual must be verified by two forms of id - one of which must be a copy of their valid driver’s license or other government issued id with a photo. Copies of these must accompany their data request form. b. Internal - Tennessee Department of Health Data Requests These requests may not require approval of the DARC. All data requests from the TDOH, including rural regional health departments, must be submitted using a data request form (aggregate or individual-level). Requests will follow the policies outlined in the flowchart on page 10. A confidentiality agreement must also be completed for any individual-level request prior to data release, signed by the person making the request and their supervisor. 3. Data Security a. Confidentiality Agreement Investigators should also be advised that the committee may require further assurances regarding the release of information to subcontractors, security of data storage, and informed consent procedures. The principal investigator will be required to read and sign a Confidentiality Agreement (see page 25). This contract describes limitations on usage of data, as well as restrictions on dissemination of findings, use of personal identifiers, and contact with patients and medical providers identified through data provided by TCR. No individual-level data will be released before this document is signed and returned to TCR. b. Data Access Review Committee (DARC) The DARC is a formal subcommittee of the TDOH Data Policy Committee. The committee’s charge is to review all applications for individual-level data. (See page 31 for current member list.) The committee will review all external applications to determine if: 1) the research is in compliance with the Tennessee Cancer Reporting Law; 2) the research is an appropriate use of TCR data; 3) the study design and methods are appropriate, and 4) provisions have been made to protect confidentiality of the data. The DARC Guidelines are listed on page 32. A step-by-step procedure for individual-level data is outlined on page 34. The committee may approve the request, suggest changes, or disapprove the request. Each DARC member must complete and return the DARC Summary Report as listed on page 33. 9 TCR Data Request Flowchart Request for Data Received Internal (w/in TDoH) External (outside TDoH) Individual-level Data Aggregate Data Aggregate Data Individual-level Data Ongoing dialogue with requester to discuss study design, methodology, relevance of research, IRB, informed consent, analysis plan, and resources required for the study Are data included in Annual Report? YES NO YES Are data included in Annual Report? Critical Review (see inset B) NO Data Access Review Committee evaluates merit of the proposed research study based on the elements of critical review, the information provided in the request for data, as well as previous studies, if applicable, that have addressed the proposed research question(s). Critical Review (see inset A) Refer requester to Annual Report Critical Review (see inset A) Request Approved Request Denied Request Approved Request Denied Request Denied Request Approved Request Denied Request Approved Letter sent to requester explaining reasons for denial Data sent to requester Inset A: 1) 2) 3) 4) 5) Are data readily available? Are data elements and analysis in compliance with HIPPA regulations for summary data? Are project goals consistent with the principles and protocols of TCR? Has adequate information been received to evaluate request? Has requester agreed to acknowledge TCR in all presentations/publications based on the data provided? Inset B: 1) 2) 3) 4) 5) 6) Are data readily available? Is research of public health importance? Is the study design methodologically sound Does the study provide benefit for residents of Tennessee? If case-control study, have cases and controls been adequately defined? Are patient identifiers required? 8) 9) 10) 11) 12) Have data security issues been addressed? Is informed consent required? Are research goals consistent with the principles and protocols of TCR? Has adequate information been received to evaluate the request? Has requester agreed to acknowledge TCR in all presentations/publications based on the 7) IRB approval: Requestor and/or TDOH IRB (both required for subject contact). data provided? 10 STATE OF TENNESSEE Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 Aggregate Data Release Policy SYSTEM NAME: Tennessee Cancer Reporting System DESCRIPTION: This policy applies to the release of aggregate data from the Tennessee Cancer Registry (TCR). Computerized information for each case of cancer occurring in Tennessee is captured from medical records of patients who have cancer. By law (T.C.A. 68-1-1001, page 36), all cancer cases diagnosed or treated in Tennessee must be reported to the TCR. Included in this database are identifying information (e.g., name, address, and social security number), demographic information (e.g., age, race, and sex) and general information about the case of cancer (e.g., primary site, histology and stage). It is important to note that not all Tennesseans with cancer are diagnosed or treated in Tennessee and not all individuals diagnosed or treated with cancer in Tennessee are Tennesseans. This database contains all cases of cancer diagnosed or treated in Tennessee regardless of residence. While non-resident cases are included in the TCR database, they are not included in any analyses, studies, reports, etc., conducted by the TCR. Non-resident cases are reported to the state of residence. Cancer cases of Tennessee residents that were diagnosed in other states are also obtained for inclusion to the TCR database. GENERAL ACCESSIBILITY: Release of aggregate data will not include access to identifying information (e.g., name and address). All identifying data captured from the medical record is considered confidential and release of aggregate data will be formatted to ensure the confidentiality of all reported cancer cases. Any person may request these data by completing a Request for Aggregate Data stating: (1) the uses for which the information is desired, (2) preferred breakdown of cases (e.g. primary site, sex, race, etc.), and (3) assurances that the data will be released, published or otherwise disseminated in accordance with the data release policies outlined by the TCR. ACCESS TO PROVISIONAL DATA: The term “provisional data” is used to describe a data file that is not considered to be finalized. Aggregate data will not be released until the data file has been finalized. 11 INACCESSIBLE RECORDS: Aggregate data are suppressed when fewer than six (6) cases are reported for any given subgroup over any given time period. Rates are suppressed when calculated based on fewer than sixteen (16) cases. These suppression rules apply regardless of time frame or for any time period. Suppression is necessary to prevent the potential identification of individuals diagnosed with cancer. CHARGE POLICY: Access to aggregate data may be provided at no charge. PROVISION OF DATA: All data will be supplied in tabular format. The data will contain all records accessible for the period of time specified by the request. All reports or manuscripts utilizing TCR data must be approved by the Office of Cancer Surveillance (OCS) prior to any distribution or publication. BREACHES OF CONFIDENTIALITY: The Tennessee Department of Health (TDOH) may choose to take legal action if confidentiality is breached. Breaches of confidentiality will require the requester to immediately cease use of the data, return all data to the TDOH, and forfeit all rights to access data in the future. 12 STATE OF TENNESSEE Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor North 425 Fifth Avenue North Nashville, TN 37243 Aggregate Data Request Name of Person Making Request Title Organization Street Address City State Zip ( Phone Number ) ( Fax Number ) - Email Address Purpose for which data is requested (please be specific, and use additional sheets if needed): Is there a deadline for receipt of data? If YES, please provide date and reason: YES NO DATE____________________ Preferred form of output: PAPER DISK CD PH – 3851 13 RDA S836-1 Description of data required: 1. Anatomical site(s): 2. Counts? 3. Rates: 4. Age-adjusted rates? 5. Time frame: 6. Sex of cases: 7. Race: Females White Black YES 10-year YES Incidence YES NO Mortality NO _______________ thru _______________ Males Other NO Other Both All Races 8. Breakdown by standard age groups? If YES, which groups? 9. Geographic Region: 10. Geographic breakdown: Census Tract Other, please explain: State 5-year County Health Department Region Requestor should be advised that rates based on 16 or fewer cases and frequencies based on five or fewer cases will be suppressed, regardless of time frame. Declaration: The Tennessee Department of Health and the Tennessee Cancer Registry will be acknowledged using the suggested references in any publications and/or presentations based on the data provided. Source: Tennessee Department of Health Office of Cancer Surveillance Reference: Tennessee Department of Health Office of Cancer Surveillance Tennessee Cancer Registry, Year(s). Nashville, Tennessee PH – 3851 14 RDA S836-1 1. I will not allow others to, nor will I myself, match this data set to other patient-level data sets, health care facility and/or professional level characteristics or use these data to identify any health care facility, health care professional or patient without prior Tennessee Cancer Registry approval. The Tennessee Department of Health, Office of Policy, Planning & Assessment, Tennessee Cancer Registry does not warrant the accuracy of any information in the records that will be provided and shall not be held liable for any inaccuracies in such records or any damages from the use thereof. I understand that a copy of any further analysis or research findings generated using these data MUST be provided to the Tennessee Cancer Registry. I understand that the Tennessee Department of Health may choose to take legal action if confidentiality is breached. Breaches of confidentiality will require that you immediately cease use of the data; return all data to the Tennessee Cancer Registry; and forfeit all rights to access data in the future. 2. 3. 4. Signature: _______________________________ Date: _____________________ Please return completed form to: Attn: Epidemiologist STATE OF TENNESSEE Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 Tele: 1-800-547-3558 Fax: (615) 532-7904 PH – 3851 15 RDA S836-1 STATE OF TENNESSEE Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 Individual-Level Data Request Policy SYSTEM NAME: Tennessee Cancer Reporting System DESCRIPTION: This policy applies to the release of individual-level records from the Tennessee Cancer Registry (TCR). Computerized information for each case of cancer occurring in Tennessee is captured from medical records of patients who have cancer. By law (T.C.A. 68-1-1001, page 40), all cancer cases diagnosed or treated in Tennessee must be reported to the Tennessee Cancer Registry. Included in this database are identifying information (e.g., name, address, and social security number), demographic information (e.g., age, race, and sex) and general information about the case of cancer (e.g., primary site, histology and stage). It is important to note that not all Tennesseans with cancer are diagnosed or treated in Tennessee and not all individuals diagnosed or treated with cancer in Tennessee are Tennesseans. This database contains all cases of cancer diagnosed or treated in Tennessee regardless of residence. While non-resident cases are included in the TCR database, they are not included in any analyses, studies, reports, etc., by the TCR. Non-resident cases are reported to the state of residence. Cancer cases of Tennessee residents that were diagnosed in other states are also obtained for inclusion to the TCR database. GENERAL ACCESSIBILITY: Release of individual cancer case records may include access to identifying information (e.g., name and address). All identifying data captured from the medical record is considered confidential and access will be limited to approved research. Access to identifying and confidential cancer information is limited to research-related requests by law consistent with T.C.A. 68-1-1001, page 40. Any person may request these data by completing an Application for Individual-Level Data stating: (1) the uses for which the information is desired, (2) reasons confidential data elements are necessary, (3) assurances that the data will be treated with the same level of confidentiality as that maintained by the TCR, and (4) that upon completion of the research project, all data provided by the TCR and all copies of these data will be destroyed or returned. Upon recommendation by the TCR Data Access Review Committee, the TCR may approve or deny the request. 16 ACCESS TO PROVISIONAL DATA: The term “provisional data” is used to describe a data file that is not considered to be finalized. Provisional cancer data are only released for research purposes when required by an approved study. INACCESSIBLE RECORDS: Confidential information with personal identifiers is accessible only to approved research projects. Data for cancer cases occurring in non-resident while in Tennessee may not be accessible. Also, data for cancer cases occurring in Tennessee residents while outside of Tennessee may not be accessible, depending on the data sharing agreement with that state or area. CHARGE POLICY: Access to individual-level cancer data may be provided to qualified, approved researchers at no charge. PROVISION OF DATA: All data will be supplied in the format requested by the researcher on CD or floppy disk. The data will contain all records accessible for the period of time specified by the research request. Requesters will be provided with documentation (e.g., code sheets and file layouts) to correctly interpret the data. Data cannot be released to any other organization or individual by the person or entity to whom the State of Tennessee provides the data. BREACHES OF CONFIDENTIALITY: The Tennessee Department of Health (TDOH) may choose to take legal action if confidentiality is breached. Breaches of confidentiality will require the requester to immediately cease use of the data, return all data to the TDOH, and forfeit all rights to access data in the future. All researchers requesting access to TCR data must complete the confidentiality agreement specific to the use of individual-level cancer incidence data. 17 STATE OF TENNESSEE Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 Individual-Level Data Request TO: Potential Research Requestor: You have inquired about obtaining access to the Tennessee Cancer Registry (TCR) database. Because you are requesting individual-level data, it is necessary to complete the enclosed application materials. The TCR Data Access Review Committee (DARC) will consider your request upon receipt of your completed application. Any areas of this application left blank without explanation will delay the review process, so please review your completed application carefully. If the DARC determines that part or all of your request can be accomplished through internal analyses, a public-use dataset, or the creation of proxy variables, we will contact you to advise you of this option. This may allow the review process to be expedited, and give the TCR the opportunity to meet your data needs in a more timely manner. Maintaining confidentiality of the individuals in our database is paramount to the mission of the TCR. For this reason, it is important that the need for confidential data containing unique identifiers be specified throughout the application. Although this process may seem arduous and repetitive, it is a small burden compared to the privilege of working with this very sensitive information, and provides assurances to the TCR that procedures are in place to safeguard TCR data. As you complete the application, you will find guidance regarding unique identifiers and proxy variables. Please feel free to contact TCR for technical assistance in decision making regarding proxy or “dummy” variables. Please select the minimum amount of variables needed for your research. This will limit the amount of data management required and minimize issues regarding patient confidentiality. TCR will make every effort to provide you with the data requested, and we ask for your help by asking only for those data elements necessary for your research project. Please send your completed application materials to the following address: Epidemiologist STATE OF TENNESSEE, Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance, Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 If you have any questions, please contact the TCR at (615) 253-5937 or (800) 547-3558 or e-mail at TNCancer.Registry@state.tn.us. 18 PH – 3852 RDA S836-1 STATE OF TENNESSEE Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 Individual-Level Data Request Part A: General Information Title of project: Date of submission to TCR (mm/dd/yyyy): Principal Investigator: __________________________________Title: Address: Organization: ___________________________________Tele #: ( E-Mail: _______________________________________Fax #: Names of Co-investigators: ) Sponsoring/funding organization (if applicable): Grant period: From:________________ to ___________________ 19 PH – 3852 RDA S836-1 Part B: Summary of Research Study Protocol: Please submit a copy of your research/study/project protocol. Use as much space as needed to answer the questions below. Attach a separate document if necessary. For TCR Review Only Included? YES NO 1. Title of study or project: 2. Need for study or project: How will this study benefit residents of Tennessee and/or public health? The answer should include the number or proportion of residents who may be affected by the results of the study. ___ ___ ___ ___ 3. Requestor’s qualifications and affiliation(s): (describe or attach resume/cv) ___ ___ 4. Personnel: List all research staff who will have access to the confidential data (include personnel, subcontractors, and affiliated agencies). ___ ___ 5. Source of funding: Describe the source(s) of all funding for the study (including in kind contributions). 6. Study background and design: If available, attach research protocol and skip to Question 7. If this request is not part of a scientific research study, please provide an abstract describing the background and design of the project and the reason for requesting individual-level data. Please address the following: ___ ___ ____ ____ • • • • What are the specific aims of your project? Specifically state the goal(s) of the research. Based on the study goal(s), provide an outline of the study, start and completion dates, and sampling or data collection methodology. Describe the study’s case definition (demographics, clinical criteria, geographic location, and any other appropriate descriptors). Describe the data analysis methods, including sub-group analyses, multi-variate models, and any software packages you anticipate utilizing in the analysis. 20 PH – 3852 RDA S836-1 For TCR Review Only Included? YES NO 7. Data management: Please describe, in detail, the methods used to store the data (include how data are accessed, use of passwords, network servers, etc.). Results: Describe the format of your results (e.g., publication, grant application poster presentation, agency brochure, internet web page, etc.). What will be the lowest geographical level of analysis that will be released for publication or presentation (e.g., state, county, census tract)? ___ ___ 8. ___ ___ ___ 9. Contact with subjects: Will the study or project activities involve contact with persons identified in the requested dataset? If so, please explain the need for, and the exact nature of, any such contact. IRB approval must also be obtained from the Tennessee Dept. of Health. Please contact Dr. Bridget McCabe or Donna Hurst for more information at bridget.mccabe@state.tn.us or donna.hurst@state.tn.us or (615) 7415225. ___ 10. Confidentiality Agreement: Please read and sign the TCR Confidentiality agreement. ___ ___ Part C: Data Elements Requested ˆ Potentially Confidential Elements Cancer Registry Patient ID Number Patient Tumor Record Number Address of residence at diagnosis City of residence at diagnosis County of residence at diagnosis Zip code of residence at diagnosis Race Age at diagnosis Date of birth Date of diagnosis Date of initial RX Provide Justification for Need, Filters, Groups Need: Need: Need: Need: Need: Need: Need: Need: Need: Need: Need: 21 Accession number – Hosp Need: Sequence number – Hosp Need: Year of diagnosis Need: State at diagnosis Need: Marital status at diagnosis Need: Sex Need: Primary Site Need: Laterality Need: Morphology (Type and Behavior) Need: Grade Need: Reporting hospital Need: Summary stage Need: **For a complete list of data elements available, please contact TCR. Part D: Data Request Specifications 1) A. Years of analysis: Please indicate analysis time frame (in years). Data are available from 1991 through current. From: ________________________ through__________________________ B. Expected date of data return/destruction___________________________ 2) Gender of subjects: ____ Males and Females ____ Males only ____ Females only 3) Age of subjects: ____ Adults only (20+) ____ Children only (under age 20) ____ All ages ____ Age range from _____ through _____ ____ Standard age groups (5-year age groups; 0-4, 5-9, ......, 74-79, 80-84, 85+) ____ User-defined age groups Specify age groups: PH – 3852 22 RDA S836-1 4) Cancer sites/histologies: Primary Sites (ICD9/ICD10/ICDO Codes) Histologies (ICDO-M Codes) 5) Geographic Areas ____ Tennessee (entire state) ____ Eastern Tennessee ____ Specific county(ies) ____ Specific Zip code(s) ____ Middle Tennessee ____ Western Tennessee Specify: ___________________________________________________ Specify: ___________________________________________________ 6) Comments: _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ PH – 3852 23 RDA S836-1 Part E: Statement by Researcher Seeking Access I, _____________________________, hereby state that all of the information provided in this application for release of data is true, complete, and correct to the best of my knowledge. _________________________________ Name of responsible party ___________________________________ Organization/Institution ________________________ Title ________________________ Telephone Number ___________________________________ Signature ________________________ Date Note: IRB approval must be obtained from an IRB formed in accordance with the provisions of the U. S. Department of Health and Human Services Code of Federal Regulations Title 45, Part 46, Protection of Human Subjects (revised November 13, 2001). A copy of the IRB must accompany the Individual-Level Data Request Application. Please contact Dr. Bridget McCabe or Donna Hurst regarding IRB approval from the TN Dept. of Health at bridget.mccabe@state.tn.us or donna.hurst@state.tn.us or (615) 741-5225. Please send completed form to: ATTN: Epidemiologist STATE OF TENNESSEE Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 24 PH – 3852 RDA S836-1 STATE OF TENNESSEE Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 Confidentiality Agreement for Individual-Level Data All persons requesting individual-level data from the Tennessee Department of Health, Tennessee Cancer Registry must agree to and sign this agreement of confidentiality. The confidentiality of cancer information reported to the TCR is of primary importance. The TCR has developed data use policies in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and expects researchers using TCR data to adhere to these policies. Breaches of confidentiality may result in legal action, and the researcher may forfeit all rights to access data in the future. 1) I agree that all information provided in the Individual-Level Data Request Application form is correct. 2) I will not allow others to, nor will I myself, use data provided by the TDOH TCR for purposes other than the study proposal and the purposes specified in this application. 3) I will not allow others to, nor will I myself, release, furnish, disclose, publish, or otherwise disseminate these data in any manner without the approval of the TCR. 4) I will not allow others to, nor will I myself, use these data to identify any health care facility and/or health care professional without prior TCR approval. 5) I will not allow others to, nor will I myself, publish, disseminate, communicate or otherwise re-release health care facility and/or professional identifiable data without prior approval from the TCR and review and comment by the affected facilities. 25 PH – 3852 RDA S836-1 6) I will not allow others to, nor will I myself, match these data set(s) to other patient-level data sets, health care facility and/or professional level characteristics without prior approval from the TCR. 7) I will not allow others to, nor will I myself, release data in a report or for dissemination with a cell size of less than six (6) or rates of less than 16 without prior approval (regardless of the time frame, or for any time period), in accordance with the data release policies of the TCR. Maps generated using geocoded data must adhere to the data suppression rules. 8) The TCR does not warrant the accuracy of any information in the records that will be provided and shall not be held liable for any inaccuracies in such records or any damages from the use thereof. Provisional data is incomplete and may contain inaccuracies. 9) I understand that these data are the property of the State of Tennessee TCR and must be surrendered or destroyed upon completion of the approved research project. 10) I understand that a copy of any results generated using these data MUST be provided to the TCR. 11) I understand that the TDOH TCR may choose to take legal action if confidentiality is breached. Breaches of confidentiality will require that you immediately cease use of the data; return all data to the TCR; and forfeit all rights to access data in the future. Principal Investigator Name: _____________________________________________ Principal Investigator Signature:__________________________________________ Date: _________________________ Co-Investigator Name:___________________________________________________ (If applicable) Co-Investigator Signature:________________________________________________ (If applicable) Date: _________________________ Supervisor Signature:___________________________________________________ (If applicable - *Required for TDOH internal data requests*) Date:________________________ 26 PH – 3852 RDA S836-1 State of Tennessee Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 Governmental & Related Agency Data Request Policy All data requests from the Tennessee Department of Health (TDOH) and other Tennessee State agencies must follow the procedures previously outlined for Aggregate and Individual-Level data requests. See Flowchart on page 10. The following agencies currently have Data Sharing No Cost Contracts with the Tennessee Cancer Registry (TCR): Metro-Nashville Health Dept., Memphis/Shelby County Health Dept., Jackson-Madison County Health Dept., Sullivan County Regional Health Dept., East TN State University, Meharry Medical College, Middle TN State University, Tennessee State University, University of Memphis, UT Memphis, Vanderbilt University Medical Center (Dept. of Preventive Medicine) and National Opinion Research. These agencies must follow the procedures previously outlined for Aggregate and Individual-Level data requests, unless specific revisions of their respective contracts allow for limited exceptions. State Cancer Registries that are contiguous with the State of Tennessee have data sharing contracts for the purpose of exchanging cancer data for Tennessee residents diagnosed and/or treated in their state. In the absence of a fully executed interstate data sharing contract, other state cancer registries shall complete and return the TDOH Request for Data form (PH-3599 Rev. 7-03) beginning on page 30. U.S. federal agencies will be handled on a case by case basis and will generally follow the same guidelines presented in this document for external data requests. The United States Department of Labor, Employment Standards Administration, Energy Employees Occupational Illness Compensation will occasionally fax a claim for Survivor Benefits under the Energy Employees Occupational Illness Compensation Program Act. The signed survivor declaration is sufficient for release of information, as per Deputy General Counsel, TDOH, Office of General Counsel. Upon the death of an individual, the confidentiality “key” he/she possessed devolves to the next-of-kin and/or legal representative, if applicable. A letter authorizing release of public health information (PHI) from a person requesting his/her own records is sufficient to release such information to that person. 27 STATE OF TENNESSEE Department Of Health Policy, Planning and Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243 Request for Data Name of Person Making Request Street Address City Type of Organization: State Zip Commerical  Phone Number ( ) Non-Profit  Other – Specify  _____________ Organization Governmental  Type of Activities Conducted by the Person/Organization: Type of Record and Time Period Requested: Purpose for Which Records Are Requested: Project Approval by an Institutional Review Board? No  Yes (if yes, please attach copy) If you plan to use confidential information to contact the registrant, his/her family, or any other person or entity named on the record, complete the following: Procedure Used for Contact: Method for Maintenance and Protection of Identifying Information: PH-3599 Rev. 7-03 Continue on back RDA S836-5 28 The undersigned certifies that he/she has read, understands, and agrees to the conditions described above that apply to the use of data provided by the State of Tennessee, Department of Health. Please initial each item and provide the information requested below. Data Release Agreement: ____1. All information provided by the requestor is correct. ____2. All fees shall be paid prior to the receipt of information. ____3. Records released by the Tennessee Department of Health will not be sold, transferred, or used for any purpose other than those stated in this request. ____4. Strict standards of confidentiality of records and information, including, but not limited to, patient medical records and other similar records shall be maintained in accordance with applicable state and federal law. All data provided will be kept confidential and will be used for the specific purpose described above. ____5. The requestor affirms it is familiar with the requirements of the Health Insurance Porability and Accountability Act (HIPAA) requirements and its accompanying regulations, and will comply with all HIPPA requirements. ____6. The appropriate source, reference, and acknowledgement will always accompany any use of these data. The guidelines specified by the Reference Guidelines document will be followed. ____7. A copy of any results generated using these data will be provided to the Tennessee Department of Health, Office of Policy, Planning and Assessment. ____8. All copies of confidential data provided for research purposes in response to this request will be destroyed at the end of the study. Paper copies should be burned or shredded and electronic records should be erased or returned to the Tennessee Department of Health. ____9. The Tennessee Department of Health may choose to take legal action if confidentiality is breached. Breaches of confidentiality will require that you immediately cease use of the data; return all data to the Tennessee Department of Health; and forfeit all rights to access data in the future. ____10. The Tennessee Department of Health does not warrant the accuracy of any information in the records that will be provided and shall not be held liable for any inaccuracies in such records or any damages from the use therof. Provisional data is incomplete and may contain inaccuracies. Signature: Date: Name (print): Title: Telephone Number (of person signing): ( ) All electronic data can be supplied in a fixed format text file. Data will be supplied via CD. Questions concerning the completion of this form or the request for information may be directed to the Tennessee Department of Health, Tennessee Cancer Registry, telephone 1-800-547-3558. For Health Department Use Only: This data was released on __________ based on IRB approval and/or Health Data Policy Committee policy. (Date) Signature:__________________________ Date:_________________ PH-3599 Rev. 7-03 RDA S836-5 29 APPENDIX Contents 1. 2. 3. 4. 5. 6. 7. 8. page Data Access Review Committee Member List……………………………………...... Data Access Review Committee Guidelines ………………………………………… Data Access Review Committee Summary Report………………………………….. Request for Individual-Level Data Procedure Outline ………………………………. Reference Guidelines ………………………………………………………………… Tennessee Code for Cancer Reporting Systems (T.C.A. 68-1-1001)………………… Tennessee Cancer Registry Reporting Rules (Chapter 1200-7-2)……………………. Glossary of Terms…………………………………………………………………….. 31 32 33 34 35 36 41 47 30 Tennessee Cancer Registry Data Access Review Committee Member list and contact information Updated 05/2008 Martin Whiteside, DC, PhD, MSPH Director of Office of Cancer Surveillance Office of Policy, Planning and Assessment Tennessee Department of Health 6th floor, Cordell Hull Bldg 425 5th Ave North Nashville, TN 37243 615-532-7903 Email: Martin.Whiteside@state.tn.us Ellen Omohundro, Ph.D. Statistical Research Specialist Division of Health Research Office of Policy, Planning and Assessment Tennessee Department of Health 4th floor, Cordell Hull Bldg 425 5th Ave North Nashville, TN 37243 615-253-6862 Email: Ellen.Omohundro@state.tn.us Qiong Li, Ph.D. Epidemiologist Office of Cancer Surveillance Office of Policy, Planning and Assessment Tennessee Department of Health 6th floor, Cordell Hull Bldg 425 5th Ave North Nashville, TN 37243 615-741-9079 Email: Qiong.Li@state.tn.us Yinmei Li, MD, Ph.D. Director of Surveillance, Epidemiology & Evaluation Section Division of Health Research Office of Policy, Planning and Assessment Tennessee Department of Health 6th Floor, Cordell Hull Bldg 425 5th Ave North Nashville, TN 37243 615-741-8190 Email:Yinmei.Li@state.tn.us David J. Law, Ph.D. Director of Division of Health Research Office of Policy, Planning and Assessment Tennessee Department of Health 4th floor, Cordell Hull Bldg 425 5th Ave North Nashville, TN 37243 615-253-4702 Email: David.Law@state.tn.us Patrick A. Turri, M.S. Director of Data Analysis Tennessee Hospital Association 500 Interstate Blvd. South Nashville, TN 37210-4634 615-401-7449 Email:pturri@tha.com 31 State of Tennessee Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6 Floor 425 Fifth Avenue North Nashville, TN 37243-5262 th Data Access Review Committee Guidelines I. Introduction The TDOH Data Policy Committee has established the Data Access Review Committee (DARC) as a formal subcommittee with delegated authority to conduct its business as defined below. The chair of the DARC subcommittee, the TCR epidemiologist, shall be responsible for preparing and submitting an annual fiscal year written report not later than July 30 of each year. The report shall contain information regarding data requests, committee disposition of requests, and minutes of subcommittee proceedings. The DARC subcommittee shall be staffed by the TCR epidemiologist and membership will be selected by the TCR program. Meetings will be set by the TCR program. Committee data requests shall be guided by the policy and procedures herein. II. Purpose of Data Access Review Committee is to ensure the confidentiality of data collected and ensure the validity of research projects utilizing TCR data. For a list of current committee members see Appendix (page 31). III. Criteria for Committee Decision Making: 1) Follow the specific requirements of the Tennessee Cancer Reporting System Act of 1983 (TCA 68-1-1001), the accompanying TDoH rules and the HIPPA Privacy Rules applicable to the release of individual-level data. 2) Determine if the research is an appropriate use of TCR data. 3) Determine if the proposed methods are appropriate for the study. 4) Verify that the study has an ending date. The TCR will not release data on an ongoing basis to supply research entities with a pool of data from which they may conduct future studies. 5) Ensure that there are adequate provisions to maintain the confidentiality of the data before, during and after the study. The data must be destroyed upon completion of the study. 6) Return decision to TCR within 15 work days of receiving. IV. Review Procedure – see page 34. 32 State of Tennessee Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243-5262 Individual & Committee Data Access Review Summary Report Individual Report _____ Committee Decision _____ Date:________________ Reviewer:____________________________________ Application Title:________________________________________________________ Principal Investigator:____________________________________________________ Organization:___________________________________________________________ City, State:_____________________________________________________________ After your evaluation of the attached materials, please check: Approved: If you find the research has adhered to all requirements and you have no questions or suggested changes. Approved with Changes: If you find the research has adhered to most requirements and you have questions or suggested changes that when answered or corrected would move the application to an approved status. Not Approved: If you find that the application does not adhere to many requirements and major changes would be necessary to move the application to an approved status. Please provide positive comments relative to how the request may be changed for resubmission. Recommendation: _____Approved _____Approved with Changes _____Not Approved Comments:_____________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ 33 State of Tennessee Department of Health Office of Policy, Planning & Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6th Floor 425 Fifth Avenue North Nashville, TN 37243-5262 Request for Individual-Level Data Procedure Outline 1) Receive request for Individual-Level data. 2) Send Request for Individual-Level Data application packet to the applicant. 3) Receive completed application packet. 4) Verify that the application is complete. 5) Prepare DARC packets for review. 6) Distribute DARC packets to committee members. 7) Receive completed DARC packets from all committee members. 8) Verify that the DARC packets are complete. Committee decision: unanimous or majority vote. 9) Send the appropriate outcome letter (Approved/Approved with Changes/Not Approved) to the requestor. 10) Receive additional information or revised application if requested. 11) Verify that the application and supporting documents are complete. 12) Send final letter. 13) Prepare data and deliver to requestor. 14) Receive study results and draft copies of any reports or publications. 15) Close study and verify data has been destroyed or returned to TCR. 34 STATE OF TENNESSEE Department Of Health Office of Policy, Planning and Assessment Office of Cancer Surveillance Tennessee Cancer Registry Cordell Hull Building, 6 Floor 425 Fifth Avenue North Nashville, TN 37243 th REFERENCE GUIDELINES It is important that all data be accompanied by the appropriate source, reference, and acknowledgement information. The appropriate reference of data provides important information to the reader and gives credit to the appropriate agencies for the collection and maintenance of data. The following source, reference, and acknowledgement information must accompany data provided by the Tennessee Department of Health. Source information must be provided for all tables, graphs, maps, and other pictorial representations of these data. Reference and acknowledgement information must be provided for any written documents that have utilized these data in any way. See the specific data system below for specific source, reference, and acknowledgement guidelines. If you have any questions, please contact the Tennessee Department of Health, Office of Policy, Planning and Assessment, Office of Cancer Surveillance at (615) 741-5548 or (800) 547-3558. Tennessee Cancer Registry Source: Tennessee Department of Health, Office of Cancer Surveillance. Reference: Tennessee Department of Health, Office of Cancer Surveillance. Tennessee Cancer Registry, Year(s). Nashville, Tennessee. Acknowledgement: Cancer data were provided by the Tennessee Department of Health, Office of Cancer Surveillance. 35 Tennessee Code Title 68, Chapter 1, Part 10 Cancer Reporting System 68-1-1001. Short title. This part shall be known and may be cited as the "Tennessee Cancer Reporting System Act of 1983." [Acts 1983, ch. 124, § 1.] 68-1-1002. Definitions. As used in this part, unless the context otherwise requires: (1) "Cancer" means and includes, but is not limited to: (A) A large group of diseases characterized by uncontrolled growth and spread of abnormal cells; (B) Any condition of tumors having the properties of anaplasia, invasion, and metastasis; (C) A cellular tumor, the natural course of which is fatal; (D) Malignant neoplasm; and (E) In-situ cancer. (2) "Commissioner" means the commissioner of health; (3) "Committee" means the cancer reporting advisory committee; (4) "Department" means the department of health; (5) "Facility" means a health care facility in which diagnosis or treatment services are provided to patients with cancer, including, but not limited to, an ambulatory surgical treatment center, a freestanding cancer treatment center, a radiation therapy center, a chemotherapy treatment center, a nursing home, an oncology or dermatology clinic, a laboratory, or any other facility which provides screening, detection, diagnostic or therapeutic services to patients with cancer. (6) "Health care practitioner" means a physician, surgeon, or other health care professional licensed under title 63 who is engaged in diagnosing and treating patients who have cancer; (7) "Hospital" means an institution as defined by § 68-11-201; (8) "In-situ cancer" means an abnormality of development and organization of cells. It is a condition of early cancer, without the invasion of neighboring tissue; 36 (9) "Laboratory" means a facility where tests are performed identifying anatomical and cytological changes, and where specimens are interpreted and pathological diagnoses are made; and (10) "Medical, scientific and academic research communities" means those institutions which devote a substantial part of their activity to research and which have internal procedures providing for the collection, study and protection of data. [Acts 1983, ch. 124, § 3; 1985, ch. 85 § 1; 2000, ch. 775, §§ 2-6.] 68-1-1003. Purpose of chapter - Reports to department – Format and contents of reports – Persons authorized to have access to patients medical records – Reimbursement – Failure to report or give access to records. (a) The purpose of this act is to ensure an accurate and continuing source of data concerning cancer and to provide appropriate data to members of the medical, scientific, and academic research communities for purposes of authorized institutional research, approved by the appropriate research committee of the applying institution, into the causes, types and demography of such diseases, including, but not limited to, the occupation, family history, and personal habits of persons diagnosed with cancer. (b) In order to accomplish the purpose described in (a), all hospitals, laboratories, facilities, and health care practitioners shall report to the department, within six (6) months after the date of diagnosis of cancer in a patient, information contained in the medical records of patients who have cancer; provided, however, health care practitioners are not required to report information on patients with cancer who are directly referred to or have been previously admitted to a hospital or a facility for cancer diagnosis or treatment. (c) The reports required by this section shall be made in such format and shall contain such information as is required by the department. The department shall make available the necessary information regarding format and data to enable hospitals, laboratories, facilities, and health care practitioners to make accurate reports to the department. (d) The commissioner or the commissioner's authorized representative may take such steps as are necessary to avoid duplicate reporting of information on the same patients, including, but not limited to, waiving the requirement for a health care practitioner to report information on cancer patients who are hospitalized or confined to a nursing home, where information on those patients has been reported by the hospital, nursing home, or other reporting source. (e) The commissioner or the commissioner's authorized representative shall be permitted to have access to the medical records of cancer patients which are maintained by 37 hospitals, laboratories, facilities, and health care practitioners where necessary to identify cases of cancer and to establish the characteristics of the cancer, the treatment of the cancer, or the medical status of an identified cancer patient. (f) If a hospital, laboratory, facility, or health care practitioner fails to report the required information to the department in an acceptable format by the required deadline, the commissioner or the commissioner's authorized representative may obtain the information by a direct examination of those patients' medical records. In such cases, the hospital, laboratory, facility, or health care practitioner shall reimburse the department for the department's reasonable expenses incurred in obtaining the information in this manner. The commissioner shall establish in rules the maximum amount of reimbursement which may be sought, and a hospital, laboratory, facility, or health care practitioner from whom reimbursement is sought may appeal the assessment of expenses under the Tennessee Uniform Administrative Procedures Act, compiled in title 4, chapter 5. (g) A hospital, laboratory, facility, or health care practitioner that fails to report information or allow access to records, as required by this section, shall be informed by the department that compliance with the requirements of this act is mandatory. [Acts 1983, ch. 124, § 4; 1985, ch. 85 § 2; 2000, ch. 775, § 7.] 68-1-1004.Reports to department - Rules and regulations. (a) The department shall require the reporting of cancer and the submission of such specified additional information on reported cases as the commissioner deems necessary and appropriate. (b) The commissioner shall promulgate such rules and regulations, including public necessity rules, as are necessary for carrying out the duties and responsibilities of the department under this part. Such promulgation shall be in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5. [Acts 1983, ch. 124, § 5; 2000, ch. 775, § 8.] 68-1-1005. [Repealed.] 68-1-1006. Confidentiality of data. (a) (1) All data obtained from the reports required by this part are for the confidential use of the department and persons that the commissioner determines are necessary to carry out the intent of this part. 38 (2) Information that could possibly identify individuals whose medical records have been used for collecting data may not be included in materials available to the public. (b) In order to carry out the legislative intent set out elsewhere in this chapter that the data obtained from the reports required by this part are also to be made available for valid research projects, the commissioner, with the advice of the advisory committee established by this chapter, is authorized to make available to members of the research community set out elsewhere in this chapter specific and personally identifiable portions of the data collected; provided, that the following guidelines are observed: (1) The researcher sets out clearly the uses for which the data are desired; (2) The researcher clearly states the reasons for which confidential and personally identifiable portions of the data are necessary; (3) The researcher assures that the data received from the department will be maintained by the researcher with the same level of confidentiality as that maintained by the department; and (4) Upon completion of the research project, all data provided by the department and all copies of the data shall be destroyed. (c) Guidelines for such research applications shall be set out by departmental regulations. For the purposes of this part, those approved to obtain data for research shall not be considered agents of the commissioner. [Acts 1983, ch. 124, § 7; 1985, ch. 85, § 4.] 68-1-1007. Liability for release of information – Compliance not violative of confidentiality. A hospital, laboratory, facility, or health care practitioner that reports information to the department or allows the commissioner or the commissioner's authorized representative access to the medical records of cancer patients, as required by this part, shall not be held liable to any person for the release of such information to the department, nor shall the release of such information to the department be construed as a violation of any requirement of law or professional obligation to maintain the confidentiality of patient information. [Acts 1983, ch. 124, § 8; 2000, ch. 775, § 10.] 68-1-1008. Tests and supervision of patients prohibited. 39 No patient whose medical records are the subject of data collected in the reports required by this part shall be subjected to any medical examination or case supervision by the commissioner or the commissioner's agents for the purposes of this part. [Acts 1983, ch. 124, § 9.] 68-1-1009. Violations - Penalties - Enforcement. (a) Any person receiving information containing the personal identity of any patient, who willfully divulges that identity, except as lawfully provided for in this chapter, commits a Class C misdemeanor. (b) It is the duty of the district attorney general to prosecute such suit when requested by the commissioner, the county health officer or local board of health. [Acts 1985, ch. 85, § 5; 1989, ch. 591, § 113.] 68-1-1010. Interstate sharing of information – Confidentiality. (a) In order to obtain complete information on Tennessee cancer patients who have been diagnosed or treated in other states and in order to provide information to other states regarding their residents who have been diagnosed or treated for cancer in Tennessee, the commissioner or the commissioner's authorized representative is hereby authorized to enter into appropriate written agreements with other states that maintain statewide cancer registries, allowing the exchange of information on cancer patients. (b) Each state with which the commissioner agrees to exchange such information must agree in writing to keep all patient-specific information confidential and to require any research personnel to whom the information is made available to keep it confidential. [Acts 2000, ch. 775, § 11.] 68-1011. Annual publishing of reports. The Department shall annually compile and publish reports utilizing the data collected pursuant to this part and shall make these reports available to the governor, the general assembly, and the public. [Acts 2000, ch. 775, § 12.] 40 RULES OF TENNESSEE DEPARTMENT OF HEALTH BUREAU OF HEALTH INFORMATICS TENNESSEE CANCER REGISTRY CHAPTER 1200-7-2 CANCER REPORTING SYSTEM April, 2002 (Revised) TABLE OF CONTENTS 1200-7-2-.01 Purpose 1200-7-2-.02 Authority 1200-7-2-.03 Definitions 1200-7-2-.04 Participation in the Program 1200-7-2-.05 Cancer Case Reporting 1200-7-2-.06 Confidentiality 1200-7-2-.07 Release of Data 1200-7-2-.08 Request Procedure for Patient Identifying Information 1200-7-2-.01 PURPOSE (1) The purpose of these regulations is to provide for the implementation of the Tennessee Cancer Reporting System Act of 1983 and its amendments requiring all hospitals, laboratories, facilities, and health care practitioners, as defined in the Act, to report certain cancer data to the Department of Health, as well as to provide for the confidentiality of certain data, and for the data to be made available to the public. Authority: T.C.A. §§4-5-202 and 68-1-1001 et seq. Administrative History: Original rule filed October 6, 1986; effective November 20, 1986. Amendment filed September 5, 1990; effective October 20, 1990. Repeal and new rule filed February 1, 2002; effective April 17, 2002. 1200-7-2-.02 AUTHORITY (1) The regulations are issued under the authority granted the Commissioner of the Tennessee Department of Health under the Cancer Reporting System Act of 1983 and its amendments, hereinafter referred to as the Act. Authority: T.C.A. §§4-5-202 and 68-l-1001 et seq. Administrative History: Original rule filed October 6, 1986; effective November 20, 1986. Repeal and new rule filed February 1, 2002; effective April 17, 2002. 1200-7-2-.03 DEFINITIONS (1) “Cancer” means and includes, but is not limited to: (a) (b) (c) (d) (e) (2) (3) a large group of diseases characterized by uncontrolled growth and spread of abnormal cells; any condition of tumors having the properties of anaplasia, invasion, and metastasis; a cellular tumor, the natural course of which is fatal; malignant neoplasm; and in-situ cancer. “Commissioner” means the Commissioner of the Department of Health. “Data” shall mean the original information contained on the report required by the regulations, including, but not limited to, both identifying and non-identifying information. 41 CANCER REPORTING SYSTEM (Rule 1200-7-2-.03, continued) (4) (5) CHAPTER 1200-7-2 “Department” shall mean the Tennessee Department of Health, or “department,” as used in the Act. “Facility” means a health care facility in which diagnosis or treatment services are provided to patients with cancer, including, but not limited to, an ambulatory surgical treatment center, a freestanding cancer treatment center, a radiation therapy center, a chemotherapy treatment center, a nursing home, an oncology or dermatology clinic, a laboratory, or any other facility which provides screening, detection, diagnostic or therapeutic services to patients with cancer. “Health care practitioner” means a physician, surgeon, or other health care professional licensed under T.C.A. Title 63 who is engaged in diagnosing and/or treating patients who have cancer. “Hospital” means an institution as defined by T.C.A. 68-11-201. “Identifying information” means any information that could lead to the identification of a patient who has been diagnosed or treated for cancer. “Laboratory” means a facility where tests are performed identifying anatomical and cytological changes, and where specimens are interpreted and pathological diagnoses are made. “Medical records” shall include, but not be limited to, pathology reports, cytology reports, radiology reports, and disease index for both inpatients and outpatients. “Person” means any member of the “medical, scientific, and academic research community.” “Policies and Procedures Manual” means the document(s) maintained in the offices of the Tennessee Cancer Registry giving specific written instructions for the implementation of policies and procedures utilized by the Registry and which may be updated from time to time. “Tennessee Cancer Registry” or “Registry” or “TCR” shall mean the program in the Tennessee Department of Health that administers a population-based statewide cancer registry. (6) (7) (8) (9) (10) (11) (12) (13) Authority: T.C.A. §§4-5-202 and 68-l-1001 et seq. Administrative History: Original rule filed October 6, 1986; effective November 20, 1986. Amendment filed September 5, 1990; effective October 20, 1990. Repeal and new rule filed February 1, 2002; effective April 17, 2002. 1200-7-2-.04 PARTICIPATION IN THE PROGRAM (1) (2) All hospitals, laboratories, facilities and health care practitioners shall report data concerning Tennessee patients who are diagnosed and/or treated for cancer. Health care practitioners are not required to report data on cancer patients who are directly referred to or have been previously admitted to a hospital or a facility for cancer diagnosis or treatment. 42 CANCER REPORTING SYSTEM (Rule 1200-7-2-.04, continued) (3) CHAPTER 1200-7-2 All hospitals, laboratories, facilities and health care practitioners shall designate one (1) staff member to be responsible for reporting the cancer data and shall notify the department of the name, title, work address, work telephone number, and e-mail address (if available) of the designated staff member. Authority: T.C.A. §§4-5-202 and 68-l-1001 et seq. Administrative History: Original rule filed October 6, 1986; effective November 20, 1986. Amendment filed September 5, 1990; effective October 20, 1990. Repeal and new rule filed February 1, 2002; effective April 17, 2002. 1200-7-2-.05 CANCER CASE REPORTING (1) Reportable Cancer Cases (a) Any newly diagnosed in-situ or invasive cancer as defined by the TCR Policies and Procedures Manual is considered a reportable diagnosis. If a patient subsequently develops a new primary cancer, it shall be reported separately. (2) Format for Reporting (a) The format for reporting, the required codes, and the standards for completeness and quality are defined by the department in the TCR Policies and Procedures Manual. (3) Data Items to be Reported (a) The standardized report of cancer shall include as a minimum those data items required by the Tennessee Cancer Registry, a list of which is maintained in the TCR Policies and Procedures Manual. The report of cancer shall include the listed demographic, diagnostic, and treatment data as defined by the department. (4) Deadline for Reporting (a) Reporting shall occur no later than six months after the date of diagnosis of cancer in a patient. Reports shall be submitted to the department according to a time frame communicated by the department to each hospital, facility, laboratory, and health care practitioner. (5) Failure to Report (a) A hospital, laboratory, facility, or health care practitioner that fails to report data or allow access to records, as required by T.C.A. 68-1-1003, shall be informed in writing by the department that compliance is mandatory. If a hospital, laboratory, facility, or health care practitioner fails to provide the required data in the format specified by the department or if the data are of unacceptable quality, the Commissioner or the Commissioner’s authorized representative may enter the facility to casefind and abstract the information. In these cases, the facility shall reimburse the department for the actual cost of casefinding, abstracting, coding and editing, a maximum of which is fifty dollars ($50) per case. A hospital, laboratory, facility or health care practitioner from whom reimbursement is sought may appeal the assessment of expenses under (b) 43 CANCER REPORTING SYSTEM (Rule 1200-7-2-.05, continued) CHAPTER 1200-7-2 the Tennessee Uniform Administrative Procedures Act. The appeal shall be to the Commissioner in writing and within thirty (30) days of receipt of the assessment. (6) Quality Assurance (a) Staff members from the Tennessee Cancer Registry or their agents shall perform periodic quality assurance studies at all reporting facilities. These studies shall include: 1. 2. (b) (c) casefinding to ensure that all cancer cases have been accessioned; and reabstracting the records of cancer patients to ensure that all data have been transcribed and coded correctly. Reporting facilities shall assist TCR staff by providing the necessary medical records and the office space for conducting quality assurance activities. In order to improve the quality of the data, the TCR or their agents shall offer training for reporting facility personnel. Authority: T.C.A. §§4-5-202 and 68-l-1001 et seq. Administrative History: Original rule filed October 6, 1986; effective November 20, 1986. Amendment filed September 5, 1990; effective October 20, 1990. Repeal and new rule filed February 1, 2002; effective April 17, 2002. 1200-7-2-.06 CONFIDENTIALITY (1) (2) T.C.A. 68-1-1006 provides for the confidentiality of data obtained from the reports of cancer patients. TCR Responsibilities (a) The commissioner shall take strict measures to ensure that all patient identifying information is treated as confidential and privileged. All employees or consultants, including auditors of the TCR, shall sign a Tennessee Cancer Registry Employee Confidentiality Pledge and these signed pledges shall be kept on file. An employee or consultant who discloses confidential identifying information willfully or through negligence is subject to penalty, including, but not limited to, the penalty in T.C.A. 68-1-1009. (3) Protection of Report Sources (a) Hospitals, laboratories, facilities, or health care practitioners who disclose cancer data to the Tennessee Cancer Registry or its employees in conformity with the Cancer Reporting System Act of 1983 and its amendments shall not be held liable for the release of such data to the department. (4) Protection of Patient Identifying Information Obtained by Special Studies and Other Research Studies 44 CANCER REPORTING SYSTEM (Rule 1200-7-2-.06, continued) CHAPTER 1200-7-2 (a) All identifying information such as records of interviews, questionnaires, reports, statements, notes, and memoranda that are procured or prepared by employees or agents of the Tennessee Cancer Registry shall be used solely for statistical, scientific and medical research purposes and shall be held strictly confidential by the TCR. This applies also to identifying information procured by any other person, agency, or organization, including public or private colleges and universities acting jointly with the TCR in connection with special cancer studies and health research investigations. Authority: T.C.A. §§4-5-202 and 68-l-1001 et seq. Administrative History: Original rule filed October 6, 1986; effective November 20, 1986. Amendment filed July 14, 1989; effective August 28, 1989. Amendment filed September 5, 1990; effective October 20, 1990. Repeal and new rule filed February 1, 2002; effective April 17, 2002. 1200-7-2-.07 RELEASE OF DATA (1) Release of non-identifying information (a) To federal agencies: 1. The TCR is authorized to collaborate with the National Program of Cancer Registries (NPCR), the Centers for Disease Control and Prevention (CDC), and the National Cancer Institute (NCI) to provide cancer incidence statistics and participate in cancer studies. (b) To the Tennessee Department of Health 1. The Tennessee Cancer Registry shall work closely with the Tennessee Department of Health in investigating cancer-related issues and in evaluating programs. Because the TCR data are an integral part of the Tennessee Department of Health cancer prevention and control programs, the use of Registry data by public health officials shall be considered an in-house activity. Data required by the Tennessee Department of Health for responding to concerns expressed about threats to the public health shall receive priority in determining the order of processing requests. (c) To the general public: 1. Public reports published by the Tennessee Cancer Registry shall include aggregate, not patient identifying information or facility identifying information. Information that would potentially identify a cancer patient shall not be published. Non-identifying information may be made available to the general public upon request to the department. The availability of any data shall depend upon the department’s financial or other ability to comply with such requests. The Registry shall respond to public requests as quickly as possible, subject to staffing constraints. 45 CANCER REPORTING SYSTEM (Rule 1200-7-2-.07, continued) (d) To Others: 1. CHAPTER 1200-7-2 The TCR is authorized to collaborate with the North American Association of Central Cancer Registries (NAACCR) to provide cancer incidence statistics and participate in cancer studies. (2) Release of identifying information (a) Identifying information collected from any hospital, laboratory, facility, or health care practitioner may be released to qualified persons for the purposes of cancer prevention, control, and research, provided that each request for identifying information follows the established procedure outlined in the TCR Policies and Procedures Manual and receives prior approval by the department. Identifying information that is collected solely by the Tennessee Cancer Registry for its own special studies shall not be released. (3) Annual Report (a) A statistical report shall be prepared at the completion of each year’s data collection cycle and will be distributed as requested. (4) Interstate Exchange of Data (a) Because cancer patients may be diagnosed or receive treatment in another state, the Commissioner or the Commissioner’s authorized representative is authorized to sign agreements with other states to acquire cancer data concerning Tennessee residents and, in return, to provide those states with data relating to their residents. Each signatory state shall agree in writing to keep all patient data confidential and privileged as defined in the contract for data exchange, a copy of which is included in the TCR Policies and Procedures Manual. Authority: T.C.A. §§4-5-202 and 68-l-1001 et seq. Administrative History: Original rule filed October 6, 1986; effective November 20, 1986. Amendment filed September 5, 1990; effective October 20, 1990. Repeal and new rule filed February 1, 2002; effective April 17, 2002. 1200-7-2-.08 REQUEST PROCEDURE FOR PATIENT IDENTIFYING INFORMATION (1) Requests for identifying information shall be reviewed and approved by the department according to the policies of the Tennessee Department of Health and the Tennessee Cancer Registry. The Tennessee Cancer Registry shall review requests for identifying information and shall recommend to the Commissioner whether to approve or deny any identifying information request. The Commissioner shall approve or deny any identifying information request after considering the reason for such request and the planned use of the identifying information. A detailed description of the procedures for requesting identifying information can be obtained from the Tennessee Cancer Registry. (2) (3) Authority: T.C.A. §§4-5-202 and 68-l-1001 et seq. Administrative History: Original rule filed February 1, 2002; effective April 17, 2002. 46 Glossary of Terms Aggregate data – data that does not include any identifiable information. Cancer – includes, but it not limited to: a) a large group of diseases characterized by uncontrolled growth and spread of abnormal cells; b) any condition of tumors having the properties of anaplasia, invasion, and metastasis; c) a cellular tumor, the natural course of which is fatal; d) malignant neoplasm; and e) in-situ cancer. Confidentiality Agreement – an agreement that must be signed when requesting individual-level data. DARC – refers to the Data Access Review Committee Data – the original information contained on the report required by the regulations including, but not limited to, both identifying and non-identifying (aggregate) information. Data Suppression – refers to the withholding of data when there are fewer than six cases or rates fewer than sixteen. External data – refers to data requested from an individual or group that is not with the Tennessee Department of Health, for example, University research requests, metropolitan regional health departments in Tennessee, other Tennessee state agencies, state cancer registries, and U.S. Federal agencies. Identifying Information – any information that could lead to the identification of a patient who has been diagnosed or treated for cancer, which includes, but is not limited to name, address, city, zip code, census tract information. Individual-level data – data that contains records with identifying information, such as name, address, city, zip code, etc. Individual-level data request form – form that is to be completed when requesting individual-level data. This request must be accompanied by a signed confidentiality agreement and an IRB. Internal data – refers to data requested from an individual or group that is within the Tennessee Department of Health. Medical records – includes, but is not limited to, pathology reports, cytology reports, radiology reports, and disease index for both inpatients and outpatients. OCS – refers to the Office of Cancer Surveillance. PPA – refers to the Office of Policy, Planning and Assessment Provisional data – data that has not yet been finalized and is not available for release. Restricted data – refers to aggregate data that includes the release of frequencies based on fewer than six (6) cases and rates based on fewer than sixteen (16) cases. These data may be released for research purposes only and shall be presented/published in accordance with TCR guidance. Tennessee Cancer Registry – (TCR or Registry) the program in the Tennessee Department of Health that administers a population-based statewide cancer registry. TDOH – refers to the Tennessee Department of Health Unrestricted data – refers to aggregate data that does not directly or indirectly identify cancer patients. This data does not include cases with fewer than six (6) or rates based on fewer than sixteen (16) cases. 48