STANDARDS FOR AUTOMATED REPORTING

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1 North Carolina Central Cancer Registry STANDARDS FOR AUTOMATED REPORTING In accordance with the North American Association of Central Cancer Registries Record Layout Version 16.0 Effective 1/1/2016 January 2016 North Carolina Central Cancer Registry State Center for Health Statistics Division of Public Health Department of Health and Human Services 1908 Mail Service Center Raleigh, NC

2 Table of Contents PART I: INTRODUCTION... 3 SECTION I.1: SUMMARY OF CHANGES FOR I.1.1: Changes to the Record Layout... 3 I.1.2: Additional Requirements for Central Registries participating in the CER Project... 3 I.1.3: Transition to Directly Coded AJCC TNM and Summary Stage... 5 SECTION I.2: SUPPLEMENTARY DOCUMENTATION... 5 SECTION I.3: AUTHORITY... 5 PART II: DATA TRANSMISSION STANDARDS... 6 SECTION II.1: SUMMARY... 6 SECTION II.2: N.C. CCR REQUIRED EXPLANATORY NOTES... 6 SECTION II.3: TRANSMISSION REQUIREMENTS... 7 II.3.1: Selection of Cases... 7 II.3.2: New Case Record... 7 II.3.3: Modified Record... 7 II.3.4: End of Record... 7 II.3.5: Record Type... 8 II.3.6: Record Version... 8 II.3.7: File Naming Requirements... 8 II.3.8: Reporting Schedule and Deadlines... 8 PART III: QUALITY CONTROL STANDARDS... 9 SECTION III.1: EDITS... 9 SECTION III.2: TEST FILE SUBMISSION... 9 PART IV: CONTACT INFORMATION... 9

3 PART I: INTRODUCTION This document is intended for software vendors responsible for developing automated reporting systems that meet the reporting requirements of the North Carolina Central Cancer Registry (N.C. CCR). It describes the format in which the collected data should be reported and the quality control checks that must be applied to submitted data. This document comprises software standards, but not the complete standards for correctness of data. Section I.1: Summary of Changes for 2016 This record layout is in accordance with the North American Association of Central Cancer Registries (NAACCR) Record Layout version 16.0 effective 1/1/2016. There are several significant changes to the record layout. Please review the record layout documentation carefully for a complete list of the changes. I.1.1: Changes to the Record Layout The NC CCR will begin using the Modified Record (record type M) instead of the former Update/Correction Record (record type U) to transmit data modifications for abstracts already submitted as New Case Records. The Modified Record has the same length (22824 characters) and contains the same fields in the same locations as the New Case Record. The primary difference is the Record Type data item (NAACCR Item#10) will indicate M for the Modified Record. Refer to Section II.3.3 for more details. The Record Layout is now being provided as a separate Excel document. The changes to the New Case and Modified record layouts and the data set for 2016 are described in detail in this Excel document. Refer to the Comments column in the Excel document specified below for a description of the changes. Changes to the record layout (new case record and modified record) have been highlighted in yellow in this document. Record Layout document for 2016: NC CCR v16.0 Record Layout for New Case and Modified Records_January 2016.xls I.1.2: Additional Requirements for Registries participating in the CER Project The N.C. CCR was designated a Specialty Registry in 2013 through its participation in the CER Project. The N.C. CCR is required to continue the collection of seven data items from the CER Non-NAACCR Standard Data Set for cases diagnosed 1/1/2011 and beyond. Information for these data items must be collected (when available in the medical record) for all sites (C00.0 C80.9). These data items are listed below and are located in the Reserved - NPCR Specific Data Items section in the record layout beginning with column position These seven data items cannot be left blank for required cases and any blanks must generate an edit to flag the abstractor to provide this information. The vendor may default the following fields to the appropriate value for unknown for certain types of cases (path only, consult only, reportable-byagreement cases, etc.). A quick reference for coding these seven data items has been provided below. Height Weight Tobacco Use (cigarette, other smoking tobacco, smokeless or tobacco NOS) Source Comorbidity

4 The record layout will continue to list all other CER data items. These data items are located in the Comparative Effectiveness Research Record Area Non-Confidential section in the record layout beginning with column position These data items (with the exception of the seven data items listed above) may be left blank for all cases except for breast, colorectal and chronic myelogenous leukemia cases diagnosed 1/1/ /31/2011. Corrections or changes to any CER data item are no longer required. N.C. CCR Specific Data Items - Quick Coding Reference: Height Two digit number recorded in inches Code 99 for unknown height Weight Three digit number recorded in pounds Code 999 for unknown weight Tobacco Use The collection of Tobacco Use is divided into four separate data items - three for specific types of tobacco products and one for when tobacco use is indicated, but type is not specified. Cigarette smoking Smoking tobacco products other than cigarettes (e.g., pipes, cigars, kreteks) Smokeless tobacco products (e.g., chewing tobacco, snuff, etc.) Tobacco, NOS Codes 0 Never used (includes when record only states None ) 1 Current user (as of date of diagnosis) 2 Former user, quit within one year of the date of diagnosis 3 Former user, quit more than one year prior to the date of diagnosis 4 Former user, unknown when quit 9 Unknown/not stated/no smoking specifics provided (includes when record only states No ) Source Comorbidity Codes 0 No comorbid/complication identified/not Applicable (Comorbid/Complication #1 is all 0 s) 1 Collected from facility face sheet (Comorbid/Complication #1 is NOT all 0 s) 2 Linkage to facility/hospital discharge data set 3 Linkage to Medicare/Medicaid data set 4 Linkage with another claims data set 5 Combination of two or more sources above 9 Other source Note there is no code for unknown. This data item cannot be defaulted to 9 for unknown. The edits check this value against the comorbidities/complications data items. The correct code will depend on whether or not comorbidities and/or complications have been recorded.

5 I.1.3: Transition to Directly Coded AJCC TNM and Summary Stage The transition from Collaborative Stage to the directly coded AJCC TNM and Summary Stage began with cases diagnosed 1/1/2014. Below is a summary of the final stage of this transition for cases diagnosed in 2016 and after: Directly assigned Summary Staging (SS1977 or SS2000 depending on year of diagnosis) will be required for ALL cases from ALL facilities. Directly assigned AJCC Staging (clinical and pathologic T, N, M and Stage Group) will be required for ALL cases from ALL facilities. Collaborative Stage will no longer be used as the primary staging system for new cases. The current CS Site Specific Factors using the current definitions will continue to be collected until further notice. Collaborative Stage is still required for cases diagnosed 1/1/ /31/2015. Important Note: Directly assigned Summary Stage and AJCC Stage is required for ALL cases. This includes non-analytic cases. If the Summary Stage or any component of the AJCC Stage AT DIAGNOSIS is known, then record in the appropriate data items. If the Summary Stage or any component of the AJCC Stage AT DIAGNOSIS is NOT known, the record the appropriate value for unknown. Section I.2: Supplementary Documentation This document does not explain how to collect or code the data to be reported. This document does not describe the valid codes or coding instructions for current or new data items. Detailed instructions for collecting and coding the required data items specified in the record layout can be found in the NAACCR Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary or the N.C. CCR Cancer Collection and Reporting Manual (CCARM). The CCARM can be downloaded from the N.C. CCR website at: Section I.3: Authority The Central Cancer Registry is established by North Carolina General Statute Chapter 130A - Article 7. Its administrative rules are codified as North Carolina Administrative Code Title 10A - Chapter 47 SubChapter B.

6 PART II: DATA TRANSMISSION STANDARDS Section II.1: Summary There are two record types that must be transmitted from the reporting facility to the N.C. CCR: New Case records and Modified records. These record types are described in Section II.3. Cases should not be transmitted using a format that is earlier than the year that the case is reportable. For example, 2016 cases, as defined by the N.C. CCR casefinding rules, cannot be submitted in the format required in Section II.2: N.C. CCR Required Explanatory Notes Reporting requirements vary by item and record type. The New Case and Modified record types are described in a separate table, which must be consulted to determine whether or not a particular item is required. The following key explains the abbreviations used in the "N.C. CCR Required column in the record layouts: Yes Yes (gen) Sel <blank> Gen by CCR Cen No Required on all cases. Valid codes, including blank and unknown (where allowable), must be used; see CCARM. Required on all cases. The facility s registry software must generate the data item value based on a standard algorithm, rather than a user manually entering the data item value. Required on selected identifiable cases, such as certain sites or years of diagnosis; see CCARM. Optional field. This is not a data item required by the N.C. CCR, but is included in the NAACCR data transmittal format. It may be left blank or filled in with NAACCR compatible data. Generated by the N.C. CCR data management system. Used by the N.C. CCR. Reporting facilities should leave these fields blank. Relates to the Modified Record. This indicates the field was required for initial reporting, but corrections should not be sent if updated.

7 Section II.3: Transmission Requirements II.3.1: Selection of Cases Only cases identified as being reportable according to the CCARM are to be included. A reporting facility may elect to abstract other types of cases to meet local interest; however, these cases are not to be transmitted to the N.C. CCR. II.3.2: New Case Record The format for the New Case Record Layout (record type A, full case abstract) is defined in Appendix A. The record length is 22,824 characters plus Carriage Return/Line Feed (CR/LF) characters. For every abstract of a reportable case that is completed at the reporting facility, a New Case Record must be sent to the N.C. CCR. II.3.3: Modified Record The NC CCR now requires facilities to use the Modified Record instead of the former Update/Correction Record to transmit data modifications for abstracts already submitted as New Case Records, see Appendix B. The Modified Record, record type M, has the same length (22824 characters) and contains the same fields in the same locations as the New Case Record, record type A. Unlike the former Update/Correction record, record type U, it is designed to allow facilities to submit the current version of an abstract, providing the cumulative updates to all of the fields since the original new case was submitted, rather than sending a separate record for each data item change. The Modified Record can only be used once the reporting facility s registry system has been converted to use the latest NAACCR record version and NC CCR coding procedure standards. The Update Must Trigger a Modified Record column in the record layout specifies which data item changes should trigger the creation of a Modified Record. Note that not all data item changes should trigger a Modified Record. Only if the reporting facility changes a data item indicated by yes in this column, should a Modified Record be created. Although only the above criteria will trigger a Modified Record, all data items in the Modified Record will be included in the record sent to the NC CCR. A Modified Record will only be generated by the vendor software after an updated field triggered the record as outlined above and 30 days have followed since the initial trigger. This will allow for multiple changes to be sent in the same Modified Record. Vendors will be responsible for tracking this timeline within the software. Hospital registrars will have these Modified Records generated and included in their monthly transmissions to the NC CCR as appropriate. There should not be any additional work effort placed on the Hospital registrars in regards to generation of these records. The field Date Case Last Changed will continue to be updated by the software during the 30 days to accurately reflect the date the abstract was last updated. II.3.4: End of Record The last character of the file must be a period [.]. This applies to New Case and Modified records.

8 II.3.5: Record Type This is a one-character field used to identify the type of record being processed. The reporting facility s computer system must supply the appropriate code letter at the time the file is created. The appropriate code for each record type is listed below: New Case = A Modified Record = M II.3.6: Record Version This field identifies the full three-character version number of the record layout. The appropriate code for each record type is listed below: New Case: NAACCR Record Version = 160 Modified Record: Version =160 II.3.7: File Naming Requirements Facilities are required to submit all files in electronic format to the N.C. CCR s Cancer Registry Web Portal. Each reporting facility has a password protected portal account specific for that facility. File names for transmitted files must conform to the following naming convention (beginning with the date the file was created) in order to facilitate sorting files at the N.C. CCR: Date of transmission (YYYYMMDD) underscore (_) plus Hospital name (or abbreviation) underscore (_) plus Number of cases Examples: _ WakeMed_253; _ WFUBMC_1754 In addition, the file description for the file must contain information describing the type of file or the file contents and the number of cases in the file. Examples: First Quarter cases Missed cases from cases 2016 Consult-Only Cases 189 cases II.3.8: Reporting Schedule and Deadlines Facilities that accession 500 or more cases each year are required to upload at least monthly. Facilities that accession less than 500 cases each year are required to upload at least quarterly but can upload more frequently if desired. All facilities must meet the timeliness requirements specified in the quarterly call for data schedule listed below. The exception is for incomplete cases. Every attempt should be made to ensure the case is as complete as possible before a case is submitted. Incomplete cases should be reviewed routinely and submitted as soon as the information can be obtained to complete the abstract. Generally, this should not affect the majority of cases. Cases abstracted in the: Must be uploaded by: First quarter October 1 Second quarter January 1 Third quarter April 1 Fourth quarter July 1

9 PART III: QUALITY CONTROL STANDARDS Section III.1: Edits One method used by the N.C. CCR for insuring data quality is to pass submitted records through computer edits to assess whether coding rules have been properly followed. All individual items will be checked for valid codes. Valid codes for specific items can be found in the CCARM. Required edits are defined in the N.C. CCR Edit Metafile and must be applied to all cases. All records submitted by reporting facilities must pass all required edits. The current N.C. CCR Edit Metafile for use with this record layout can be downloaded from the N.C. CCR website at: The edit logic is described in detail in the Standards for Cancer Registries, (Vol. IV) NAACCR Standard Edits, NAACCR v16.0 (and later versions) Edit Detail Report. Section III.2: Test File Submission Hospitals, other reporting sources and vendors that will be submitting data (or supporting submission of data) to the N.C. CCR must demonstrate that they have procedures in place to assure the accuracy of the data being collected. This includes: 1. Data conforms to the specifications previously described in this document. 2. Software allows all valid values in data item fields. 3. All records pass the required edits. The test file should contain approximately 50 cases and include all cases covering one month, three months, or six months; whichever time period is closest to 50 cases. The file should contain a sample that is representative of the normal caseload. After the submission is evaluated, the facility or vendor will receive notification of problems detected and what changes, if any, need to be made before the data can be accepted. Each time this document is revised, or a vendor changes the registry software, additional test files must be submitted to demonstrate that they meet the new requirements. PART IV: CONTACT INFORMATION Vendor Communications and Record Layouts: Barbara Hempel, , Barbara.Hempel@dhhs.nc.gov Dianna Stucky, , Dianna.Stucky@dhhs.nc.gov Edits and Metafiles: Barbara Hempel, , Barbara.Hempel@dhhs.nc.gov Eureka and Database Administration: John Sammerson, , John.Sammerson@dhhs.nc.gov Eureka Uploads, Account User ID and Passwords: Nichole Baker, , Nichole.Baker@dhhs.nc.gov

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