ACR CAS Portal User Guide LCSR
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The American College of Radiology Lung Cancer Screening Registry (LCSR) User Guide June 29, 2017 American College of Radiology 1891 Preston White Drive Reston, VA 20191-4397 Copyright © 2017, American College of Radiology. All rights reserved. LCSR User Guide Revisions Date Description of Revisions September 2, 2015 Original issue February 1, 2016 4.1.5 Replaced ‘Canceling a Case’ with current instructions and screen shots February 25, 2016 4.3 Upload Data File 4.4 Web-based Data Transmission Appendix 1 LCSR Data Upload File Specifications v1 March 9, 2016 Appendix 1 How to Change Your Computer Settings Appendix 2 LCSR Data Upload File Specifications v1 March 28, 2016 4.4 Removed IT document hypertext links April 18, 2016 Appendix 2 LCSR Data Upload File Specifications v1.2 Appendix 3 NRDR LCSR Data Mapping and Business Rules for Data Upload May 26, 2016 Appendix 2 Other comorbidities, other specify If Patient_Other_Comorbidities includes 8, then Patient_Other_Comorbidities_Spec is required (removed ‘is 2’) Appendix 1 Added corrections to number 1, 6, 10 and 11. Replaced pic at number 11. July 25, 2016 Data Entry Convention. First and Last Names now require a minimum of 1 character instead of 2. 4.3.1 Data fields such as “Other, specify” can now accept up to 255 characters rather than the previous 45. Modified Appendix 1. Deleted Excel document language. Inserted additional .csv and .txt language. August 9, 2016 Date of follow-up; Required when submitting Follow-Up for a case; cannot be a future date (updated) September 20, 2016 `4.2.2 Register New Case for Returning Patients – added as a new section `Added “Of Note” comments to Patient SSN, Medicare Beneficiary ID, Register New Case for Returning Patients, Registration, Appendix 1, Editing an ‘In-Progress’ or ‘Completed’ Form, Section A 'General’, and Radiologist (reading) sections `4.5.3 LCSR File Upload Status - updated `Patient ID has been removed from New Case Registration Search filter, Registration form, Exam form, Case Status Report forms, and all Registration & Cancellation form email notifications `6.1.1 Adding or Removing Participating Physicians - updated `LCSR Introduction Webinar – link to PPT has been added to Section 1, Introduction November 15, 2016 4.4 Web-based Data Transmission & Vendor Certification Process (added) December 19, 2016 Appendix 3, Number_Of_Packs_Year_Smoking, Unknown = 999 Appendix 3, Number_Of_Years_Since_Quit, Unknown = 99 March 24, 2017 Appendix 3, Patient Height and Weight, Unknown = 0 April 24, 2017 M_Status, added M1c May 22, 2017 Appendix 3, Overall Stage, Mappings/Definitions, N3 has been removed. ‘Unknown’ has been added. June 6, 2017 Appendix 3, Overall Stage, Valid Values/format, N3 has been removed. Unknown’ has been added. June 29, 2017 Appendix 3, Added column ‘A’ to display row number Appendix 3, changed the order of ‘Ordering practitioner NPI’ to appear after ‘Radiologist Reading NPI’ June 29, 2017 2 LCSR User Guide THIS PAGE INTENTIONALLY LEFT BLANK June 29, 2017 3 LCSR User Guide Table of Content REVISIONS ................................................................................................................................... 2 TABLE OF CONTENT .................................................................................................................. 4 1. INTRODUCTION ..................................................................................................................... 6 2. USER INTERFACE ................................................................................................................. 6 2.1. User Interface Overview ................................................................................................6 2.2. Login .............................................................................................................................7 2.3. Navigation .....................................................................................................................7 3. FORMS AND DATA DICTIONARY ......................................................................................... 8 3.1. 3.2. 3.3. 3.4. Entire Form Package.....................................................................................................8 Case Registration Form ................................................................................................8 Exam Form....................................................................................................................8 Data Dictionary ..............................................................................................................8 4. DATA COLLECTION .............................................................................................................. 8 4.1. Data Collection Overview ..............................................................................................8 4.2. Manual Data Entry.........................................................................................................9 4.2.1 Register New Case ...........................................................................................10 4.2.2 Register New Case for Returning Patients .......................................................12 4.2.3 Registration ......................................................................................................13 4.2.4 Exam ................................................................................................................14 4.2.5 Section A 'General’ ...........................................................................................15 4.2.6 Section B ‘Follow-up within 1 year’ ...................................................................16 4.2.7 Section C ‘Additional Risk Factors’ Additional risk factors are optional ............18 4.3.2 Saving a Partially Completed Form ..................................................................19 4.3.3 Finding a Form .................................................................................................19 4.3.4 Editing an ‘In-Progress’ or ‘Completed’ Form ...................................................20 4.3.5 Cancelling a Case ............................................................................................22 4.5. Flat File Upload ...........................................................................................................24 4.5.1 Populate and Configure the LCSR Data File ....................................................24 4.5.2 Upload LCSR Data File Instructions .................................................................24 4.5.3 LCSR File Upload Status ..................................................................................25 4.6. Web-based Data Transmission & Vendor Certification Process .................................27 5. REPORTS ............................................................................................................................. 28 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. Reports Overview ........................................................................................................28 Accrual ........................................................................................................................28 Case Status.................................................................................................................29 Case Detail..................................................................................................................30 Aggregate Reports ......................................................................................................31 LCSR Data Export .......................................................................................................31 6. REGISTRY MANAGEMENT ................................................................................................. 32 6.1. Registration Information ..............................................................................................32 June 29, 2017 4 LCSR User Guide 6.1.1. 6.1.2. Adding or Removing Participating Physicians ..................................................33 Adding or Removing Facility Users...................................................................36 7. GLOSSARY .......................................................................................................................... 36 APPENDIX 1................................................................................................................................ 38 APPENDIX 2................................................................................................................................ 44 APPENDIX 3................................................................................................................................ 49 June 29, 2017 5 LCSR User Guide 1. INTRODUCTION The American College of Radiology’s Lung Cancer Screening Registry (LCSR) is part of the National Radiology Data Registry (NRDR), a web-based collection of registries related to various radiological procedures. The LCSR allows facilities to collect data about lung cancer screening procedures, including patients’ demographic information, medical history and risk factors, procedure indications, and follow-up information. Data from each procedure are entered on the following forms: 1. 2. Case Registration Form Exam Form The LCSR also provides online reports summarizing case status information. The LCSR shares patient, physician and user dictionaries with the other registries included in NRDR. Consequently, information entered in the dictionaries/Manage Patient/Manage Physician lists, need only be entered once, regardless of the number of registries/databases in which a facility participates. Certain fields on the LCSR forms are automatically populated using data from these dictionaries/lists, whenever you enter a patient, physician or user ID. *Before you begin the process of LCSR Registration, Data Collection and Submission, Report Review or adding reading radiologists, we highly recommend that you watch the audio version 30-minute PowerPoint presentation located on our LCSR webpage. Its speed can be adjusted to your learning requirements and needs. After launching the LCSR Introduction Webinar, go to the Tool Bar and locate and click on the ‘Slide Show’ tab, and then click on ‘From Beginning’. The slide deck will begin with audio at the first slide. You can access the LCSR through the NRDR website at http://nrdr.acr.org. If you have any questions or difficulties using the website, please contact the NRDR Help Desk, at nrdr@acr.org or 1-800-227-5463, extension 3535. For more information on NRDR, refer to the NRDR User Guide, available on the NRDR website. 2. USER INTERFACE 2.1. User Interface Overview You must have a user type, user name and password to log in to the LCSR. Once logged in, you will have access to data from your facility only. The person who registers your facility in NRDR is known as the Facility Administrator, and is assigned a user type, user name and password during the NRDR registration process. Other users at your site are assigned a user type, user name and password when he or she is added to the NRDR user dictionary. For information about the registration process, refer to Section 2, “Getting Started”, in the NRDR User Guide. For information about adding users to the user dictionary, refer to Section 6.3.1, “Adding Users”, in the NRDR User Guide. June 29, 2017 6 LCSR User Guide 2.2. Login To log in to the LCSR, access the NRDR home page at https://nrdr.acr.org/Portal/Nrdr/Main/page.aspx and click “LCSR” on the left side. Select your user type from the drop-down list and pause while the page is refreshed. Fill in your user name, facility ID and password and click the “Log In” button. Login If this is the first time you have logged in using a temporary password, that is, a password generated for you by the NRDR system, you will be asked to changed it (refer to Section 4.5, “Changing Passwords”, in the NRDR User Guide). 2.3. Navigation The top part of each page is a status bar showing your user type, user name, and facility ID. A “Logout” button also appears. Click this button to terminate your session. If you have not yet logged in, these fields will be blank, and a “Log In” button appears. Enter your login information and click the “Log In” button to begin your session. A link to the online help pages appears in the upper right corner of some pages. The left part of each page in the LCSR contains the LCSR menu. The menu is comprised of a list of links giving you access to various registry functions. LCSR pages are distinguished from other pages in the NRDR system by the LCSR banner at the top of the page. Click the button to expand a menu item, or the button to collapse it. LCSR Banner and Menu Filters are available on most data entry pages. You can use these filters to search for a form from a specific case. A case is a set of forms related to one exam. A case includes a Case Registration form and an Exam Form. Throughout this document, “Submit” refers to the action you take when you have completed data entry for a form, and you want the entries to be recorded in the registry. “Save” refers to the action you take when you have partially completed a form and you want to continue data entry at a later date. The entries you made prior to the “Save” action will appear on the form when you continue data entry, but they will not be recorded in the registry until you perform the “Submit” action. You also perform the “Save” action when you want to make changes to a previously submitted form. If you have entered invalid data or performed an incorrect action, the system will display a red error message next to the invalid item, if applicable, and at the bottom of the page. ‼ Note: Do not use the “Back” button on your browser to navigate to a form; doing so will prevent your data from being stored in the registry. Always use the “Data Collection” menu items to navigate to a form. June 29, 2017 7 LCSR User Guide 3. FORMS AND DATA DICTIONARY Click a form title under “Forms and Data Dictionary” to view or print a paper copy of the form. 3.1. Entire Form Package You can view and print all LCSR forms at once by clicking “Entire Form Package” under “Forms and Data Dictionary” in the LCSR menu. Note: The use of these printable LCSR forms is optional and is for the facility’s workflow only. All data recorded on the printed forms will need to be provided to the NRDR via submission to your registered facility, according to the requirements as indicated in this User Guide. Do not mail these forms to the ACR. 3.2. Case Registration Form The Case Registration form is the first form to be completed when recording a lung cancer screening exam. A new form is required for each exam, even if you have previously recorded a different lung cancer screening exam for this patient. You can view and print the Case Registration form by clicking “Case Registration Form” under “Forms and Data Dictionary” in the LCSR menu. Refer to Section 1, “Register New Case”, below, for instructions on completing the form. Note: The use of these printable LCSR forms is optional and is for the facility’s workflow only. All data recorded on the printed forms will need to be provided to the NRDR via submission to your registered facility, according to the requirements as indicated in this User Guide. Do not mail these forms to the ACR. 3.3. Exam Form Complete the Exam Form during or after the lung cancer screening exam. You can view and print the Exam Form by clicking “Exam Form” under “Forms and Data Dictionary” in the LCSR menu. Refer to Section 4.2.4, “Exam”, below, for instructions on completing the form. Note: The use of these printable LCSR forms is optional and is for the facility’s workflow only. All data recorded on the printed forms will need to be provided to the NRDR via submission to your registered facility, according to the requirements as indicated in this User Guide. Do not mail these forms to the ACR. 3.4. Data Dictionary You can view and print a list of data element definitions by clicking “Data Dictionary” under “Forms and Data Dictionary” in the LCSR menu. 4. DATA COLLECTION 4.1. Data Collection Overview Throughout this document, “Submit” refers to the action you take when you have completed data entry for a form, and you want the entries to be recorded in the registry. “Save” refers to the action you take when you have partially completed a form and you want to continue data entry at a later date. The entries you made prior to the “Save” action will appear on the form when you continue data entry, but they will not be recorded in the registry until you perform the “Submit” action. You also perform the “Save” action when you want to make changes to a previously submitted form. 8 June 29, 2017 LCSR User Guide ‼ Note: for security purposes, your session will terminate automatically after 20 minutes of inactivity. Any entries you may have made since clicking the “Save” button will be lost. 4.2.Manual Data Entry In general the procedure for data collection is as follows: 1. Print paper copies of the data collection forms by selecting links under “Forms and Data Dictionary” from the LCSR menu. If you have a Master – Child registration for a multi-center facility, all exam data for the LCSR should be entered at the Child facility level (avoid entering data directly into the Master facility). Note: The use of these printable LCSR forms is optional and is for the facility’s workflow only. All data recorded on the printed forms will need to be provided to the NRDR via submission to your registered facility, according to the requirements as indicated in this User Guide. Do not mail these forms to the ACR. 2. The following forms are required for each facility contributing LCSR data: Case Registration Form Exam Form Alternately, you may log in to NRDR and enter data directly for a patient. Any individual with a facility user account can log in and enter data. 3. Select “Entire Form Package” to print all forms at once. 4. Record the information requested on the paper forms. 5. If this is the first time a procedure has been recorded in NRDR for the patient, the information you enter in the “Patient Information” section of the Case Registration Form will automatically create a patient record in the ‘Manage Patient’ list. 6. Enter data from each of the required forms, starting with the Case Registration form, by selecting the corresponding link under “Data Collection” from the LCSR menu. After completing each form, click the “Submit” button at the bottom of the page. Forms must be entered in the following order: 7. Use the Use the ‼ Case Registration Form Exam Form If errors are detected when you click the “Submit” button, they will be flagged in messages that appear in red next to the appropriate field and at the bottom of the page. You must correct these errors and click the “Submit” button again before you can proceed to the next form. If no errors are detected, a confirmation message will appear. In the case of the Case Registration Form, the message will include a link to the next data collection form, that is, the Exam Form. You may either continue with data entry, or log in at a later time to resume the process. button to view data element definitions. and buttons to show or hide form sections. Note: Do not use the “Back” button on your browser to navigate to a form; doing so will prevent your data from being stored in the registry. Always use the “Data Collection” menu items to navigate to a form. June 29, 2017 9 LCSR User Guide 4.2.1 Register New Case Every new case should be a low dose lung screening CT (baseline or annual screening). For example, if a patient had a baseline (or annual screening) LDCT lung screening and has another one greater than 12 months later, the LDCT at >12 months should be submitted to the data registry as a new case. However, if a patient returns less than 12 months from the baseline (or annual screening) then that exam must be included in Section B of the LDCT case that preceded it. You register a new case by clicking “Register New Case” under “Data Collection” in the LCSR menu. Complete the form as follows: Facility ID Number This field is populated automatically. Case Registration Date Enter the date that the paper form was completed. If paper forms were not used, then the date can be the same as the day you began the new case. Patient Information Enter the patient information requested in Section 1, “Patient Information”, of the Case Registration form. Fields marked with an asterisk (*) are required. Specific instructions for each field are as follows: *Patient SSN Patient SSN (Social Security Number) must have the following format: NNN-NN-NNNN, where N is a digit; all digits are required. Of note: If the patient refused to provide a SSN or you are not in possession of the SSN for any reason, the response to ‘None/Refused to Answer’ is to click inside the radio button next to the ‘Refused to provide SSN’. This will prevent the appearance of an error message at the bottom of the form when you click on the Submit button. *If you do have the SSN, then click ‘SSN Available’ and provide such in the data field beneath. *Medicare Beneficiary ID The Medicare Beneficiary ID is required for Medicare reimbursement. This ID is also known as the Medicare Health Insurance Claim Number. Enter this field without any special characters. For example, if a beneficiary ID is 123-34-5678A, enter it as 123345678A. Of note: If the patient refused to provide a Medicare Beneficiary ID or you are not in possession of the Medicare Beneficiary ID for any reason, the response to ‘None/Refused to Answer’ is to click inside the radio button next to the word ‘Yes’. This will prevent the appearance of an error message at the bottom of the form when you click on the Submit button. *If you are in possession of the Medicare Beneficiary ID, please click “No” and provide the ID in the data field beneath. June 29, 2017 10 LCSR User Guide Other Identification If neither the Patient SSN nor Medicare Beneficiary ID is provided, then the Other Identification field must be filled in. It must be a code that uniquely identifies the patient within your practice, such as a medical record number. Last Name First Name Refer to Section 4.3, “Data Entry Conventions”, above. Middle Name Middle Name is optional. If entered, it must start with a letter. The remaining characters can be letters, or the characters" ' ", "-", or "." . *Date of Birth Date of Birth must be at least 3 weeks prior to the current date. Race Select the patient’s race(s) as identified by the patient. More than one race may be selected. Patient ethnicity Select whether the patient is of Hispanic origin, as identified by the patient. Health insurance Select all that apply. Date of Death Enter the patient’s date of death in mm/dd/yyyy format, if applicable. *Examination date Enter the date the exam was completed in mm/dd/yyyy format. The date must not be greater than the current date. Name of person who completed the paper form This is the name of the person who performed the data collection for the exam. If this person’s name was not previously entered in a case record, then type the person’s first and last name in the corresponding data fields. In the future, the name will appear in the drop-down list. If the name was previously entered, simply click the arrow and select it from the drop-down list. Note: If the paper forms were not used, please populate this field nonetheless. It can contain the name of the person completing the on-line data submission. Name of person submitting this form Submission Date These fields are filled in automatically. Click the “Submit” button. You must correct any errors before proceeding to the Exam form. If no errors are detected, a confirmation message and a link to the Exam form will appear. The case will be assigned an “In Progress” status until the Exam form is completed and submitted as well. June 29, 2017 11 LCSR User Guide 4.2.2 Register New Case for Returning Patients For all returning patients, go to LCSR Data Collection on the LCSR Menu, click on Register New Case, and click the expand the purple Search bar. button to Search Bar Use one of the three key identifiers (the SSN, the Medicare Beneficiary ID, or Other Identification) to locate your returning patient and then click Find. Patient Search Filter The LCSR software will locate the returning patient and auto-populate all data fields in Section 1 of the Case Registration form with the data stored in the ‘Manage Patient’ list. The ‘Manage Patient’ list would have been auto-populated with the patient’s profile information during the first New Case registration. In order to prevent duplicating a patient profile, we heavily suggest careful data entry while providing one or more of the three key patient identifiers. Please do NOT populate any of the data fields in the new case until after the patient’s profile has been imported into your current Register New Case form. You may then scroll down the remaining registration form and populating such with current data, new exam date, etc. You may click the Submit button if all the required data fields have been completed, if they have not, an error message will appear across the bottom of the form indicating the data fields that need completion. Once you have completed the form, click June 29, 2017 12 LCSR User Guide Submit to advance to the Exam form. If you do not have the data in order to complete the registration form, you can click the Save button to return to it later, to edit, and then click Submit to advance to the Exam form. Of note: the LCSR software cannot advance any user to the Exam form until the required data fields, marked with an asterisk, and are populated. 4.2.3 Registration The “Registration” link located on the LCSR menu is used for editing Case Registration forms that have already been saved or submitted. The Registration form and the Exam form cannot be edited from the same link on the LCSR menu. To edit a case Registration form, you must select the Registration link on the side menu. To access the Exam form, you must select the Exam link on the side menu. Follow the remaining instructions to edit the existing form. To edit a registration form: 1. Click the “Registration” link in the LCSR menu. June 29, 2017 13 LCSR User Guide 2. Click the button on the search bar, next to “Filter”. The following box appears: Case Registration Search Filter 3. Narrow the list of forms in the search results by entering values in one or more of the other fields that appear in the box. 4. Click “Search”. A list of Case Registration forms matching the search criteria appears. You can also click “Reset” to clear the search fields and start again. Case Registration Search Results 5. Click the case number of the form you want to edit. Of note: If you are editing a form that has been submitted (by clicking on the Submit button) then you cannot Submit the form again, however, you will be able to save the form by first adding comments in the comment box, and then by clicking the Save button. Any new data that has been saved will be incorporated in the next reporting cycle. Please keep in mind, if you want to register a new case, click the “Register New Case” link under “Data Collection” in the LCSR menu and follow the instructions as detailed in Register New Case section of this document. 4.2.4 Exam After you submit the registration form, a link to the Exam form will appear. You can also access the Exam form by clicking “Exam” under “Data Collection” in the LCSR menu. Complete the form by selecting from among the options presented on the June 29, 2017 14 LCSR User Guide form, and filling in the blank fields. All fields are required unless otherwise indicated below. Specific instructions for each field are as follows: Facility ID Number Registry Case Number Patient First Name Patient Last Name Examination Date These fields are auto-populated with data that was provided in the case registration form. 4.2.5 Section A 'General’ Smoking Status For current or former smokers, estimate the number of pack-years. One pack-year is the equivalent of smoking one pack of cigarettes per day for one year. For example, 10 pack-years is the equivalent of smoking one pack of cigarettes per day for ten years, or two packs of cigarettes per day for five years. Did physician provide smoking cessation guidance to patient? Indicate “yes” if guidance was provided by either the imaging or ordering physician. Is there documentation of shared decision making? Select the appropriate response. Patient’s Height Enter patient’s height in inches. Of note: If you do not know the patient’s height, please enter the number 0 in the data field. However, moving forward, we expect you to provide the correct data. The expectation of complete and correct data is specified in the participation agreement signed by all participating facilities. Patient’s Weight Enter patient’s weight in pounds. Of note: If you do not know the patient’s weight, please enter the number 0 in the data field. However, moving forward, we expect you to provide the correct data. The expectation of complete and correct data is specified in the participation agreement signed by all participating facilities. Other comorbidities listed on patient record that limit life expectancy Select all that apply. Cancer related history Select all that apply. Radiologist (reading) Of Note: The physician’s name must be selected from the drop-down list. In order for a physician to be listed as the reading radiologist, he or she must be listed in the ‘Manage Physician’ list and on the ‘LCSR Registration Information’ page. See Registration Information, below, for data entry instructions to add reading radiologists on both physician lists. The Physician NPI is filled in automatically from the ‘Manage Physician’ list. Ordering Practitioner Enter the first and last name and NPI of the ordering practitioner. Indication for Exam Select the appropriate response. June 29, 2017 15 LCSR User Guide Modality Select the appropriate modality. CT scanner Enter the manufacturer and model of the CT scanner used to perform the exam. If the scanner has already been entered on a previous record, you can use the drop down box to select the scanner. Screening CT Radiation Exposure Enter the exam parameters. Tube current-time, tube voltage, scanning time, scanning volume and pitch are optional. CT Exam Results by Lung-RADS Category Select the appropriate response. Other clinically significant or potentially significant abnormalities – CT exam result modifier S Select the appropriate response. Prior history of lung cancer – CT exam result modifier C Select the appropriate response. Years since prior diagnosis of lung cancer Enter number of years as whole number. 4.2.6 Section B ‘Follow-up within 1 year’ A follow-up record may be added for an exam at any time during the year between screening exams. If more than one exam form exists for a patient, enter the follow-up record on the most recent exam form whose exam date is less than or equal to the date of follow-up. 4.2.6.1 Adding Follow-up to a Case You may add follow-up data to a submitted case by clicking “Exam” under Data Collection for the LCSR menu. Click the corresponding Case # for the patient for whom you want to add follow-up data. The submitted Exam form will display previously saved information. Click to expand “B. Follow-up within 1 year”: June 29, 2017 16 LCSR User Guide Then click “Add Follow-up Record”. You may enter all required and/or applicable information for the follow-up record. Remember to click “Save” to add the follow-up data to the Exam form. Every follow-up procedure should have a record on the Exam form. If you need to remove the record, you may use the “Delete Follow-up Record” button to remove the follow-up information from the Exam form. Date of Follow-up Please enter date in mm/dd/yyyy format. Follow-up diagnostic Select appropriate the response. (The following apply for procedures that resulted in a tissue diagnosis. Not applicable for imaging follow-up.) Tissue Diagnosis Select the appropriate response. Tissue Diagnosis Method Select the appropriate response. Location from which sample was obtained Select all responses that apply. Histology Select the appropriate response. Stage- Clinical or pathologic Select the appropriate response. Overall stage Select the appropriate response. T Status Select the appropriate response. N Status Select the appropriate response. M Status Select the appropriate response. Period of follow-up for incidence (in months) Enter number of months as a whole number. June 29, 2017 17 LCSR User Guide 4.2.7 Section C ‘Additional Risk Factors’ Additional risk factors are optional Education level Select patient’s highest level of education Radiation exposure - documented high exposure levels Select the appropriate response. Occupational exposures to agents that are identified specifically as carcinogens targeting the lungs Select all responses that apply. History of cancers that is associated with an increased risk of developing a new primary lung cancer Select all responses that apply. Lung cancer in first-degree relative Select the appropriate response. Family history of lung cancer, other than first-degree relative Select the appropriate response. COPD (chronic obstructive pulmonary disease) Select the appropriate response. Pulmonary Fibrosis Select the appropriate response. Second hand smoke exposure Select the appropriate response. Name of Person Who Completed the Paper Form This is the name of the person who performed the data collection for the exam. If this person’s name was not previously entered in a case record, then type the person’s first and last name in the corresponding data fields. In the future, the name will appear in the drop-down list. If the name was previously entered, simply click the arrow and select it from the drop-down list. Note: If the paper forms were not used, please populate this field nonetheless. It can contain the name of the person completing the on-line data submission. Name of Person Submitting This Form Submission Date These fields are filled in automatically. Click the “Submit” button when the form is complete. The case will be assigned “Completed” status. 4.3.1.1 Data Entry Conventions Please note the following when entering data: Dates must be entered in mm/dd/yyyy format. First and last names must be 45 characters long or less. At least 1 characters must be from the characters from "A” to “Z", "a” to “z", or " ' ". Additional characters can include a hyphen (“-"). June 29, 2017 18 LCSR User Guide Data elements defined as alphanumeric, other than first and last names, must include the characters “A-Z”, “a-z”, “09” or “_” (underlining) only. Entries must not contain leading or trailing blanks. Sections 1 and 4.2.4 contain information regarding the format used for entries on specific forms. Clicking the button that appears next to some entries will also display format information in many cases. Many items on the LCSR forms provide a list of possible values, as well as a field labeled “other, specify” where an alternative value may be provided. Unless otherwise specified, entries in these fields must be 255 characters long or less. 4.3.2 Saving a Partially Completed Form If you want to save a partially completed form, click the “Save” button at the bottom of the form. You will be able to continue entering data on the form at a later time. You will not be able to start entering data on an Exam form until the corresponding Case Registration form is complete. If you end your session without clicking the “Save” button, or without correcting errors after clicking the “Submit” button, your entries will be lost. ‼ Note: for security purposes, your session will terminate automatically after 20 minutes of inactivity. Any entries you may have made since clicking the “Save” button will be lost. 4.3.3 Finding a Form To find a form that has already been saved or submitted, do the following: 1. Click “Registration” or “Exam” under “Data Collection” in the LCSR menu. 2. Click the button on the search bar, next to “Filter”. The following box appears: Form Search Filter 3. To find all forms, leave the “Form Status” field unchanged as “All”. To find only forms that have already been submitted, change “Form Status” from “All” to “Submitted” using the drop-down list. To find forms that have been saved but not submitted, change “Form Status” to “Available”. To find forms that have been cancelled, change “Form June 29, 2017 19 LCSR User Guide Status” to “Cancelled”. You can narrow the list of forms in the search results by entering values in one or more of the other search fields, such as “First Name” or “Last Name”. 4. Click “Search”. A list of forms matching your search criteria appears. You can also click “Reset” to clear the search fields and start again. Click on a Case # to proceed with exam. Search Results 5. Click the ‘Case ID’ to launch the form. 4.3.4 Editing an ‘In-Progress’ or ‘Completed’ Form To complete an In-Progress case record, or to make changes to a previously submitted case record, go to LCSR menu on the left-hand side, and click on Registration to view the case list. Click on the ‘Case ID’ within the case list to launch the case record. LCSR Case List Table Once the case registration record is open; you may complete or edit the desired data fields, scroll to the bottom and click ‘Submit’ to complete a form. After you have submitted a form, you cannot submit it again, however you can save any edits you have made to the form. 20 June 29, 2017 LCSR User Guide Of Note: Additional edits that have been made to a form between reporting cycles will be reflected in the next report. LCSR Case Registration Form If you have made edits to a previously submitted form, then you must enter a comment in the field at the bottom of the page, to explaining the changes made to the form. Comments cannot exceed 250 characters. Afterwards, you may click the “Save” button. Field for Entering Change Description If any errors appear in red, scroll up the form and make the corrections. This image cannot currently be displayed. Save and Submit Options Of note: 1. -if you receive an error that requires an SSN and you do not have one, scroll to the top to locate the SSN data field, and click inside the ‘Refused to provide SSN’ to remove the error message. 2. -If you receive an error that requires a Medicare Beneficiary ID but your patient is not enrolled in Medicare, scroll to the top of the form, and click inside the ‘Yes’ circle for ‘None/Refused to Answer’ to remove the error message. 3. -If the SSN and Medicare Beneficiary ID have not been provided, you must provide some other form of identification, eg., medical record number, in the ‘Other Identification’ field. It is imperative to provide one of the three key patient identification methods above in order to proceed to the Exam form. June 29, 2017 21 LCSR User Guide Patient SSN, MBI and Other ID Once the errors have been corrected, go to the bottom, complete the comment section, and click ‘Submit’. The page will refresh with a message to advance to the Exam form where you can continue with data entry. ‼ Note: The system does not save historical data. Once you save a form with changes, the values that were previously in the edited fields are lost. When you make a change to a form that has previously been submitted, the system saves your name, the date the change was made, and the corresponding comment. You can click the “History” button at the bottom of the page to view information about previous changes. History Display 4.3.5 Cancelling a Case To cancel a case, click ‘Registration’ under “Data Collection” on the LCSR menu. Click ‘Registration’ and allow the page to refresh (note: It is not possible to delete a record permanently). The status for the list of cases may vary. For ‘In Progress’ and ‘Completed’ status case records, please review the procedures as indicated below. LCSR Menu Options June 29, 2017 22 LCSR User Guide A. ‘In Progress’ status when both the Registration and Exam Forms Have Been ‘Saved’: Locate the case record you want to cancel from the list of cases. Click on the ‘Case #’ to open the case record. Scroll to the bottom of the case to locate the ‘Cancel’ button. Registration: Case Record List Click ‘Cancel’ to change the ‘In Progress’ status to ‘Canceled’ status. Registration Form ‘In Progress’ Showing “Cancel” Button To review the change in status, click ‘Registration’ from the menu, and reopen the list of cases. The revised case list will show the change in status as ‘Cancelled’. Registration: Case Record List with Cancelled Status Record If you canceled a case record in error, go to the case list from the ‘Registration’ link (to open the list of cases), select the record using the ‘Case #’, scroll to the bottom and click ‘Restore.’ Restoring a Case Previously Canceled B. ‘In Progress’ status when only the Registration Form Has Been ‘Saved’: If there is only a submitted case registration form (and no exam form) then the registration record status will be ‘In Progress’ and cannot be accessed using the ‘Registration’ link on the menu. You must use the ‘Exam’ link to open and access the case list. Select the case record from the list by using the ‘Case #’, allow the form to open and scroll to the end of the form. Click ‘Cancel’. LCSR Menu Options June 29, 2017 23 LCSR User Guide Exam: Case Record List with In-Progress Status Record C. ‘Completed’ status: Cancelling a ‘Completed’ case record is a two-step process if both the Registration and the Exam form have both been ‘Submitted’. Make sure to cancel the exam form first by doing the following: LCSR Menu Options 1. Go to the ‘Exam’ link on the menu (green arrow), click on it to open the list of cases. Click on the case record using the ‘Case #’ to open it, then scroll to the bottom and click on the ‘Cancel’ button. 2. Once the ‘exam’ form is canceled, click on the ‘Registration’ link (blue arrow) on the menu to view the list of case records. You will notice that your Registration form is now in the ‘In Progress’ status; select the case record using the ‘Case #’, when the case opens, scroll to the bottom and click the ‘Cancel’ button. To review the change in status, click ‘Registration’ from the menu, and reopen the list of cases. The revised case list will show the change in status as ‘Cancelled’. 4.5.Flat File Upload Rather than entering one case at a time according to the manual entry data process, you can upload many case records at a time using the specifications and instructions provided below. 4.5.1 Populate and Configure the LCSR Data File Before using the file specifications to create your data file, you may need to change the settings on your PC first (See Appendix 1 for change settings instruction). Afterward, use the information in Appendix 2 to configure the data file itself. All data mapping definitions and business rules have been provided in Appendix 3 for a flat file upload and must be adhered to in order to facilitate a successful upload. 4.5.2 Upload LCSR Data File Instructions 1. Log in to NRDR portal using your log-in credentials and password 2. Click the LCSR link located on the menu on the left-hand side of the page 3. Click the Upload Data link June 29, 2017 24 LCSR User Guide 4. Click Choose File to select your data file 5. Click Upload LCSR Upload Data page Note: The NRDR does not load the data files right away; they are placed in a queue and will be loaded by a scheduled job. 4.5.3 LCSR File Upload Status The data file upload status can be checked using Data File Process Status located on the LCSR menu. If you have many data file uploads to review consider using a query by date, otherwise, leave the date range blank to view all your data file uploads. LCSR Data File Process Status 1. The ‘Status’ column displays the file upload status. The Upload File Status table also lists the ‘# of records in the file’, ‘# of records rejected’, ‘# of records added’, and the ‘# of records updated’. 2. The log files (far right column) will display error messages/warnings for invalid/rejected cases and can be downloaded and opened in Excel. You may select from the ‘Download Log File’ to view the data in .txt, or, you may select ‘Show Log File’ which displays messages in a cleaner format. We recommend ‘Show Log File’ for users who are not familiar with .txt documents. June 29, 2017 25 LCSR User Guide Download Log File - Sample Show Log File - sample 3. For files that are successfully uploaded, the cases will be uploaded to the database. However, the case status (whether Completed or In-Progress) cannot be determined from the Upload File Status table. Users will have to navigate to ‘Registration’ or ‘Exam’ located on the LCSR menu. Click on ‘Filter’ to open the filter window (red arrow), and choose from ‘Case Status’ (blue arrow) to review any In-progress case records which will be in need of completion. To complete a case record, please review instructions for “Editing an In-Progress or Completed Form” in the sections above. June 29, 2017 26 LCSR User Guide LCSR Registration/Exam Search Case 4.6.Web-based Data Transmission & Vendor Certification Process Thank you for your interest in submitting data electronically to the LCSR. Software vendors and interested facilities are required to be authenticated by the ACR Connect service in order to submit data to the LCSR registry. Our ACR Connect Authentication Service document is available upon request and describes the necessary steps for data submission. 1. Request the following documents below via email to nrdr@acr.org. • • • ACR Connect Authentication Service ACR LCSR JSON Mapping NRDR LCSR Exam Data Exchange 2. Once received, please review the documents. If you have any questions, send an e-mail to nrdr@acr.org requesting clarification. 3. When you are ready to begin testing, send an e-mail to nrdr@acr.org to request credentials to our testing environment. June 29, 2017 27 LCSR User Guide 5. REPORTS 5.1.Reports Overview You can view the following reports from the LCSR website. Make your report type selection directly from the LCSR menu. Accrual Report (available to Facility Administrators and Registry Administrators only) Case Status Report Case Detail Report Aggregate Reports (provided by ACR on a quarterly reporting cycle) LCSR Data Export o Case Report o Exam Report You can only view data from your own facility. Reports are displayed in new browser windows. To navigate report pages shown as HTML documents, use the navigation buttons: To print a report shown as an HTML document, click the button. To zoom in on or out of a report shown as an HTML document, select a scale percent from the drop-down list. To export a report shown as an HTML document, in Excel format, click the “Export to Excel 97-2000” button in the toolbar at the top of the page: 5.2. Accrual The Accrual Report shows the number of cases that have been registered, cancelled and completed at your facility, as well as the number of cases in progress. To view the report, click “Accrual” under “Reports” in the LCSR menu. The report appears as an HTML document. Only Facility Administrators and Registry Administrators can view this report. June 29, 2017 28 LCSR User Guide LCSR Accrual Report 5.3. Case Status The Case Status Report shows patient ID, patient SSN, physician, case status, and form submission dates for each case. All users can view this report. To view the report, click “Case Status” under “Reports” in the LCSR menu. The Case Status Report filter appears: Case Status Report Filter The LCSR Facility Number, LCSR Facility Name and LCSR Facility Medicare Provider Number are automatically filled in and cannot be changed. You can narrow the cases that will appear in the report by entering search criteria in any of the other fields shown. If you leave all fields blank, the report will include all cases for your facility. To run the report, click the “Submit” button. The report will appear in a new window as an Excel spreadsheet. June 29, 2017 29 LCSR User Guide Case Status Report Results - Sample 5.4. Case Detail The Case Detail Report shows most data elements from each case, with one row per case. All users can view this report. To view the report, click “Case Detail” under “Reports” in the LCSR menu. The Case Detail Report filter appears: Case Detail Report Filter The LCSR Facility Number and LCSR Facility Name are automatically filled in and cannot be changed. You can narrow the cases that will appear in the report by entering search criteria in any of the other fields shown. If you leave all fields blank, the report will include all cases for your facility. To run the report, click the “Submit” button. The report will appear in a new window as an Excel spreadsheet. June 29, 2017 30 LCSR User Guide Case Detail Report Result- Sample 5.5. Aggregate Reports At the end of each reporting period, your facility will be provided with a report comparing your data with aggregate data from other LCSR facilities. You can view a list of these reports by clicking “Download Reports” in the LCSR menu. List of reports available for downloading You can download a report by clicking the “Download” link on this page. 5.6. LCSR Data Export Clicking “LCSR Data Export” in the LCSR Menu generates three tables: the Lung Case Report, the Lung Exam Report and the Lung Follow-Up Report. These reports show your facility’s data as provided in the registration and exam forms. Each table opens in a new window as an Excel spreadsheet and may appear as a zip file. Click on the zip file to allow the reports to populate to your PC. There is no filter to restrict the data displayed; data from all forms submitted by your facility will be included. LCSR Data Export Each file can then be opened as an Excel document from your PC. June 29, 2017 31 LCSR User Guide Lung Case Report - Result (Detail) Sample Lung Exam Report - Result (Detail) Sample Lung Follow-up - Result (Detail) Sample 6. REGISTRY MANAGEMENT 6.1. Registration Information You can view information about your facility’s LCSR registration by clicking “Registration Information” under “Registry Management” in the LCSR menu. June 29, 2017 32 LCSR User Guide If your facility is not an LCSR participant, and you are the Facility Administrator, you can register for the LCSR by entering the number of participating radiologists in the first field and clicking the “Registration” button. Refer to Section 2.3.4, “Lung Cancer Screening Registration”, in the NRDR User Guide for more information. 6.1.1. Adding or Removing Participating Physicians In order for a physician to be listed as the reading radiologist on a LCSR Exam Form, he or she must be listed as a LCSR participant in the ‘Manage Physician’ list. You can indicate that a physician is a LCSR participant by clicking the “Add Physician” button on the “Registration Information” page. Of Note: An adding reading radiologist to the NRDR and LCSR data pages is a two-step process. First add the radiologists’ information to “Manage Physicians” list on the NRDR Homepage for your facility’s registration as specified below in Step 1, then import the radiologists’ names to the LCSR Registration Information page by following the instructions below in Step 2. Once the reading radiologists’ names appear in both places their names and NPI numbers will populate in the Exam forms’ drop-down list. For security reasons, we ask that facilities maintain control of who has access to their accounts. Towards that end, I have provided instructions below to help you manage your facility’s Physicians’ users. Step 1 - How to Add Physicians to the ‘Manage Physician’ List You must be either the Facility Administrator or a Registry Administrator to complete this task. Log into your facility as you normally would. 1. Go to the link for ‘Manage Physicians’ which appears in the menu on the left-hand side of your page. Click on Manage Physicians to open the page. 2. Two options will appear on screen: the Physician Upload option or the on-line Questionnaire. Both options have been described below. a. Physician Upload Option: If you have many radiologists that need to be added to the Manage Physician dictionaries for several registered facilities, you may want to consider the Physician Excel Upload option. In stead of completing the online questionnaire mutiple times, go to the upload option which appears above the questionnaire. Click the ‘here’ link to launch the Excel spreadsheet, add all of your physician information, save the document to your PC, and then browse to select it & upload to the dictionary. The document can be used for any facility so long as you change the Facility ID number on the spreadsheet to match the facility ID you are working with. b. On-line Questionnaire Option: If you have only a few radiologists in your group that you want to add to the Manage Physician list, then this option is the better tool to work with. The instructions for such have been provided below in detail. i. ii. June 29, 2017 Complete the questionnaire by completing all the required responses (see questionnaire below). If the physician you are adding is going to participate in the PQRS, click the ‘Yes’ radio button (see green highlight) and then create a User Name for the physician so that access the PQRS Physician Portal becomes available. a. Example of a User Name convention: use the first letter of the first name and the entire last name; b. My name is Victoria Obrien, using the convention above, my User Name would be VObrien. 33 LCSR User Guide iii. June 29, 2017 i. If the physician is NOT going to participate in the PQRS option then this step can be skipped. ii. For the purposes of LCSR, this step is not needed and can be skipped. iii. The fields within the red box do not apply to LCSR reading radiologists and can be skipped. Once the fields have been completed, click Submit. Then follow directions in Step 2. 34 LCSR User Guide Step 2: Importing Radiologists Names and NPI Numbers Go to the link for ‘LCSR’ which appears in the menu on the left-hand side of your page. Click on ‘LCSR’ to launch the LCSR menu. Once on the LCSR menu, look for ‘Registration Information’ and click to launch the page When the Registration Information page opens, it will display several questions, go to Question 2 ‘Participating Physicians’ and click on the ‘Add Physician’ button. "Add Physician" Button on the LCSR “Registration Information” Page After you have made entries in the ‘Manage Physician’ list, the list of physicians will appear in a pop-up box. Checkboxes will be located to the right-hand side of the physician names that were added during the Manage Physician process. Click inside the checkbox for all physicians you would like to be displayed in the Exam form drop-down box option, and then click ‘Add’. Adding a Physician as a LCSR Participant June 29, 2017 35 LCSR User Guide All physician names that you selected will also appear beneath Question 2, ‘Participating Physicians’ on the LCSR’s Registration Information page. Participating Physicians You can remove a physician’s association with LCSR by clicking the Remove link next to his or her name on the “Participating Physicians” list. The physician will remain in the NRDR ‘Manage Physician’ list, however, and LCSR forms previously entered for the physician will not be affected. The ability to add and remove physicians is not available to Facility Users. 6.1.2. Adding or Removing Facility Users You can add Facility Users who are authorized to perform data entry in LCSR by clicking the “Add Facility User” button. "Add Facility User" Button on the “Registration Information” Page Facility Users must exist in the user dictionary before you can add them as LCSR users. Refer to Section 6.3.1, “Adding Users”, in the NRDR User Guide for instructions on how to add users to the User Dictionary. You can remove a Facility User’s association with LCSR by clicking the Remove link next to his or her name on the “Staff” list. The user will remain in the NRDR User Dictionary, however, and LCSR forms previously entered by the user will not be affected. The ability to add and remove Facility Users is available to Facility Administrators and Registry Administrators only. If you want to add or remove Facility Administrators or Registry Administrators, you must do so in the NRDR User Dictionary. Refer to the NRDR User Guide, Section 6.3, “User Dictionary”, for additional information. 7. GLOSSARY ACR American College of Radiology Case A set of forms related to one exam. A case includes a Case Registration form and Exam form. June 29, 2017 36 LCSR User Guide CT Computed Tomography Facility Administrator The person performing the NRDR registration process. The Facility Administrator has access to certain administrative functions that are unavailable to other staff members. Only one staff member at a facility may act as Facility Administrator. Refer to Section 4.2, “Facility Administrators”, in the NRDR User Guide, for additional information. Facility User A person designated by a Facility Administrator or Registry Administrator as having data entry functions for a specific registry. Refer to Section 4.4, “Facility Users”, in the NRDR User Guide, for additional information. LCSR menu A list of links that appears on the left side of the LCSR home page and other LCSR pages. LCSR pages are distinguished from pages belonging to other registries by the LCSR banner at the top of the page. NPI National Provider Identifier NRDR National Radiology Data Registry Registry Administrator A person designated by the Facility Administrator as having certain administrative functions for a specific registry. Refer to Section 4.3, “Registry Administrators”, in the NRDR User Guide, for additional information. SSN Social Security Number June 29, 2017 37 LCSR User Guide APPENDIX 1 HOW TO CONVERT THE LCSR UPLOAD TEMPLATE TO A .TXT FILE The NRDR LCSR has provided an ‘Upload Template for LCSR Record Layout’ as a suggested method for populating the required and optional data fields as described in Appendix 2 and 3 below. It is not required that you use this formatting tool. It is your responsibility to verify that the data contained in the resulting txt file are correct. In order to convert an Upload Template file to the specifications required for a successful data flat file upload, detailed instructions have been provided here. 1. Click the Windows button on the bottom left of your screen. These steps will change your PC settings to insure that leading zeros in the Upload Template will be retained and that it will produce a pipe delimited .txt file. 2. Click Control panel June 29, 2017 38 LCSR User Guide 3. 4. Click Region and language Click the drop down arrow for Short Date and change your setting to MM/dd/yyyy and click Apply. This new setting will insure that leading zeros will be retained in the Upload Template. June 29, 2017 39 LCSR User Guide 5. Next, go to Additional settings 6. In the List separator field, replace (comma) with | (vertical bar). Do not use the drop down arrow. Place your cursor in the field, delete the comma and insert the vertical bar Using the Shift + vertical bar key (see pic of key board for location of the vertical bar key) June 29, 2017 40 LCSR User Guide 7. 8. 9. Click Apply, then OK Open the Upload Template for LCSR Record Layout, and save to your PC. In the example below, the downloaded template is named LCSR Upload Template and the file exention is .csv Enter Data: Complete each data field with patient exam data according to the Business Rules in Appendix 3. Make sure the first row of the Upload Template has a column header for each of the 84 columns, regardless of whether they are populated or not. Before entering data in the “Other ID” and “Medicare Beneficiary ID” columns, change the cell formats to “Text”. 10. When you have completed the data entry, save the file. 11. Find the file you just saved (ending with .csv) and right click over the file name (do not open the document) and manualy delete the csv letters which appear on the righ-hand side of the dot (.) in the file name and replace it with txt. a. File as .csv b. File after converting to .txt 12. If you cannot locate the file you just saved and you cannot see the file extention ending with .csv, the following instructions will display the file extention inorder to select the correct document. Note: Each version of Windows has a different set of steps to follow for showing the file extension. It would help to know the version of Windows your computer is using. Below are instructions for Windows 7: a) Start Windows Explorer b) Click Organize. c) Click Folder and search options. June 29, 2017 41 LCSR User Guide d) Click the View tab. e) Scroll down until you notice Hide extensions for known file types, un-check this by clicking the check box (To hide file name extensions, you will have to check this box). f) Click OK 13. During the course of changing a file extention from .csv to .txt, you might receive a warning message like the one below. Please click YES to proceed. Once your document is in the .txt format, it can be uploaded to the LCSR. If you have any difficulty performing the settings above, please contact your IT department to assist you with this process. Once your settings have been established, proceed to the file specifications in Appendix 2 and Business Rules for populating the template with content in Appendix 3. Of note: the most common errors that occur during a flat file upload are: 1. Incorrect document file name as specified in Appendix 2 2. Content within the template did not follow the Business Rules in Appendix 3 Make certain each cell in the template has the correct permissible reponse: June 29, 2017 42 LCSR User Guide For example, the word ‘No’ does not meet the Business Rule requirements. All ‘No’ entries must be replaced with a captial letter ‘N’. All ‘Yes’ responses should be ‘Y’ and so on. June 29, 2017 43 LCSR User Guide APPENDIX 2 NRDR - LCSR Data File Specifications for Manual Upload (v1.2) The LCSR allows you to upload lung cancer screen exam data in bulk using the manual upload function in the NRDR portal. You may use the pre-formatted Upload Template document to begin populating the fields discussed here and in Appendix 3. It is not required that you use the ‘Upload Template for LCSR Record Layout’ however it is available for your use. The LCSR Exam data file specifications are listed as follows: 1. 2. 3. 4. The data file is a delimited text file. The maximum recommended file size is 40 M. The filename extension is ‘.txt’. The file naming convention is lcsr_exam_yyyymmdd-hrmiss; yyyymmdd-hrmiss is the time stamp at the time the file is created, where yyyy is the 4 digit year, mm is the 2 digit month, dd is the 2 digit day, hr is the 2 digit hour in military time format, mi is the 2 digit minute, and ss is the 2 digit second Example: lcsr_exam_20160306-181224.txt 5. 6. The data file must contain at least one record. Each line must contain one and only one record; record delimiter is the CARRIAGE RETURN character followed by the LINE FEED character. 7. No header row (if you are using the template, the header row will display as a rejected record however the remaining patient data will be retained) 8. Each record must begin at the first position of a line. 9. Each record has 84 data elements. 10. Each data element must be positioned in the order specified below: Data element position June 29, 2017 Data Element 1 Exam Unique ID 2 Patient First Name 3 Patient Middle Name 4 Patient Last Name 5 Other ID 6 Refused To Answer SSN 7 Patient SSN 8 Refused Medicare ID 9 Medicare Beneficiary ID 10 Date Of Birth 11 Date Of Death 12 How Cause Was Determined 44 LCSR User Guide 13 14 Cause Of Death 15 Non Lung Cancer Cause 16 Death Within 30 Days 17 Patient Sex 18 Patient Race 19 Patient Ethnicity 20 Health Insurance 21 Smoking Status 22 Number Of Packs Year Smoking 23 Number Of Years Since Quit 24 Did Physician Provide Guidance 25 Doc Of Shared Dec Making 26 Patient Height 27 Patient Weight 28 Patient Other Comorbidities 29 30 Patient Other Comorbidities Spec Cancer Related History 31 Cancer Related History Other Spec 32 Radiologist Reading NPI 33 Ordering Practitioner NPI 34 35 Ordering Practitioner First Name Ordering Practitioner Last Name 36 Exam Date 37 Signs Or Symptoms Of Lung Cancer 38 Indication Of Exam 39 Modality 40 CT Scanner Manufacturer 41 CT Scanner Model 42 CTDIvol 43 DLP 44 Tube Current Time 45 Tube Voltage 46 Scanning Time 47 Scanning Volume 48 Pitch 49 Reconstructed Image Width 50 CT Exam Result Lung RADS 51 Reason For Recall 52 CT Exam Result Modifier S 53 June 29, 2017 Other Method Of Determining What Were The Other Findings 45 LCSR User Guide 54 Mass Spec 55 Other Int Lung Disease 56 Other Int Lung Disease Spec 57 CT Exam Result Modifier C 58 Years Since Prior Diagnosis 59 Education Level 60 Education Level Other Spec 61 Radon Exposure 62 Occupational Exposures 63 History Of Cancers 64 Other_Smoking Cancers Spec 65 Lung Cancer In First Deg Rel 66 Lung Cancer Other First Deg Rel 67 COPD 68 Pulmonary Fibrosis 69 Second Hand Smoke Exposure 70 Date Of Follow-Up 71 Follow-Up Diagnostic 72 73 74 75 Follow-Up Diagnostic Other Spec Tissue Diagnosis Tissue Diagnosis Method Location From Sample Obtained 76 Location Other Spec 77 Histology 78 Histology Non-Small Cell LC 79 Other Non-Small Cell LC Histology Spec 80 Stage Clinical Or Pathologic 81 Overall Stage 82 T Status 83 N Status 84 M Status 11. Each data element is separated by the vertical bar character ‘|’; if there is no answer for a data element you should write the ‘|’ character immediately after the previous ‘|’. Do not use the SPACE character to substitute for no data value. Example: Let’s use the first nine data elements as an example. Suppose we only have data for Patient first name, Patient last name, Patient Medicare id, and we refuse to provide patient SSN, then the data should be written as: |John||Doe||Y||N|A-123456| 12. The data mapping and business rules are outlined in Exam and Follow-up sections of the ACR-LCSR-Data-Mapping Appendix 3. The Transaction Header section does not apply to the data file used by the Data File Upload process; it is used by the Web Services interface. June 29, 2017 46 LCSR User Guide Explanations on the Valid values/format, Mappings/definitions and Business rules columns: a. Acceptable values and data format. For most data elements the LCSR validates their values and/or formats. Refer to the Valid values/format column on ACR-LCSR-Data-Mapping for the acceptable values and data formats. Examples: i. The element “Refused to provide patient’s social security number” accepts ‘Y’ or ‘N’ as a valid value. Any other value provided will result in an error and the file upload will not be successful. ii. “Patient Social Security Number” accepts only 9 digits in the nnn-nn-nnnn format. iii. “How cause of death was determined” accepts one value, the valid values are 1,2,3,4,5,6,or 8. The Mappings/definitions column on ACR-LCSR-Data-Mapping lists the options/text for each value. iv. “Number of packs-per year of smoking” accepts only whole numbers between 1 and 999. v. “Number of years since quit” accepts only whole numbers between 1 and 99. vi. All dates have to be in mm/dd/yyyy format. b. Data elements that accept more than one value. If a data element accepts multiple answers, each value must be separated by the comma character ‘,’ in the data file. These data elements are indicated as “Select all that apply” under the Mapping/definitions column. Example: i. “Patient race” accepts multiple values. If a patient has the “American Indian” and “Alaska native” race, it should be written as: |1,2| c. Data dependency. Some data elements need to be populated depending on a) whether another element is populated or b) the value of another element. These conditions are listed under Business Rules column on the ACR-LCSR-Data-Mapping Excel file. Examples: i. One of the patient identifiers must be provided: Other ID, Patient SSN, and Medicare Beneficiary ID. ii. “Patient Social Security Number” is required only if “Refused to provide patient’s social security number” has a value of ‘N’. This field has to be left blank if “Refused to provide patient’s social security number” is ‘Y’. iii. If “Smoking status” is 1, 2 or 4, then “Number of packs-year of smoking” is required; otherwise “Number of packs-year of smoking” should be left blank iv. If “Smoking status” is 2 , then “Number of years since quit” is required; otherwise “Number of years since quit” should be left blank v. If “Follow-up diagnostic” is 4, 5 or 6, then “Tissue Diagnosis” is required. If Follow-up diagnostic value is 7, then “Tissue Diagnosis” is optional. Otherwise, “Tissue diagnosis” is not required. vi. If “How cause of death was determined” has a value 8 (Other), then “Other method of determining cause of death, specify” is required; otherwise, this element should be left blank. d. June 29, 2017 Optional data elements. The data elements that are marked as “Optional” under the Business Rules column are not required for submission, that is, a record will not be rejected if an optional field is missing. However, if you do know them, we expect you to provide them. This expectation of complete data is specified in the participation agreement signed by all participating facilities. 47 LCSR User Guide 13. The key identifier for an exam record is the exam date and patient Id (Other ID, Patient SSN or Medicare Beneficiary Id). If you want to update an already uploaded record you can submit subsequent record(s) with the same key identifier. The system will ignore data elements with no values in the subsequent records and will not clear the values uploaded earlier. To clear any values you will have to use the LCSR web form on the NRDR portal to manually remove them. 14. When an exam record is uploaded with data missing for one or more required or conditionally required data elements, warning messages are generated in the log file, the exam will still be created with an “In progress” status. You will have to use the LCSR web form on the NRDR portal to manually populate the missing data and then submit the exam. In order to have a “complete” status on an exam record, you must submit the data elements marked as “Required” or conditionally required as indicated under the Business Rules column. 15. The relationship of Exam and Follow-up records is one-to-many. If you are submitting multiple follow-up records for an exam in the same data file, each follow-up record must occupy one row with the same key identifier on the exam record. June 29, 2017 48 LCSR User Guide APPENDIX 3 NRDR - LCSR Data Mapping and Business Rules for Flat File Upload Business Rules LCSR Data Element Attribute Format Note: The required data elements in this column are the minimum data elements required to submit an exam record and create a "skeleton" exam record in the LCSR Valid Values/format Mappings/ Definitions Note: the data elements indicated as Required in this column are required to create a complete exam/follow-up record in LCSR. If you do not have values for the required elements you will receive warning messages but the exam record will still be created. Exam Data (Required) Exam_Uniqu e_ID Exam_Unique_ID string N max length is 50 characters Optional You may provide an identifier to link back to your internal record. 1 2 3 4 Patient's first name Patient_First_Na me string N max length is 45 characters Patient's middle name Patient_Middle_ Name string N max length is 45 characters Patient's last name Patient_Last_Na me string N max length is 45 characters Patient ID Other_ID string We require a patient identifier; you can provide either the Other_ID, Patient_SSN or Medicare_Ben eficiary_ID. see Business Rule N max length is 50 characters 5 6 Refused to provide patient's social security number Refused_To_Ans wer_SSN June 29, 2017 string Note that this is not the key identifier of an exam record in LCSR. The exam date and patient ID make up the key identifier. Optional If providing first name, at least 1 characters are needed. Optional If providing middle name, at least 1 character is needed. Optional If providing last name, at least 2 characters are needed. One of the following patient identifiers must be provided: Other_ID, Patient_SSN, Medicare_Beneficiary_ID. You may use the patient's MR# as Other_ID Y, N Select one: Y - Yes; N - No Required 49 LCSR User Guide Patient Social Security Number Patient_SSN string 7 8 Refused to provide patient's Medicare beneficiary ID Medicare Beneficiary ID Refused_Medica re_ID string Medicare_Benefi ciary_ID string 9 We require a patient identifier; you can provide either the Other_ID, Patient_SSN or Medicare_Ben eficiary_ID. see Business Rule N 9-digits, nnn-nn-nnnn We require to have a patient identifier; you can provide either the Other_ID, Patient_SSN or Medicare_Ben eficiary_ID. see Business Rule max length is 12 characters if Refused_To_Answer_SSN is 'Y' then you must leave this field blank; if Refused_To_Answer_SSN is 'N' then you must provide Patient_SSN; Y, N Select one: Y - Yes; N - No One of the following patient identifiers must be provided: Other_ID, Patient_SSN, Medicare_Beneficiary_ID Required You must provide Medicare_Beneficiary_ID if this is for Medicare reimbursement. if Refused_Medicare_ID is 'Y' then you must leave this field blank; if Refused_Medicare_ID is 'N' then you must provide Medicare_Beneficiary_ID; One of the following patient identifiers must be provided: Other_ID, Patient_SSN, Medicare_Beneficiary_ID 10 11 Patient's date of birth Date_Of_Birth string Patient's date of death Date_Of_Death How cause of death was determined How_Cause_Was _Determined string Other method of determining cause of death, specify Other_Method_ Of_Determining string N format mm/dd/yyyy Cannot be a future date; must be <= Date_Of_Death string N N format mm/dd/yyyy Optional 1,2,3,4,5,6,8 Cannot be a future date; must be >= Date_Of_Birth Optional 12 13 Required N max length is 255 characters Select one: 1 - 'Autopsy Report'; 2 - 'Death Certificate' ; 3 - 'Medical Record' ; 4 - 'Physician'; 5 - 'Relative or Friend'; 6 - 'Social Security Death Index'; 8 - 'Other' Only applicable if Date_of_Death is provided Optional If How_Cause_Was_Determine d is 8, then Other_Method_Of_Determin ing is applicable otherwise, this field should be left blank June 29, 2017 50 LCSR User Guide Cause of death Cause_Of_Death string N 1,2,9 Non lungcancer cause, specify Non_Lung_Canc er_Cause string N max length is 255 characters 14 15 Select one: 1 -'Lung cancer' ; 2- 'Non-lung cancer cause, specify if known' ; 9- 'Cannot determine' Required if Date_of_Death is provided Optional If Cause_of_Death is 2 then Non_Lung_Cancer_Cause is applicable; otherwise, this field should be left blank 16 Invasive procedure within in the 30 days preceding date of death Death_Within_3 0_Days string N Patient sex Patient_Sex string N Patient race Patient_Race array of number Patient ethnicity (Hispanic origin) Patient_Ethnicity Health insurance N, Y, U Select one: N - No; Y - Yes; U - 'Unknown' If Date_of_Death is provided then Death_Within_30_Days is required. M,F,O,U Select one: M - 'Male'; F - 'Female'; O - 'Other'; U - 'Unknown' Required N 1,2,3,4,5,6,9,10 Select all that apply: 1 - American Indian 2 - Alaska native 3 - Asian 4 - Black or African American 5 - Native Hawaiian or Pacific Islander 6 - White 9 - Not reported 10 - Unknown Optional string N 0,1,8,9 Select one: 0 - 'Not Hispanic or Latino'; 1 - 'Hispanic or Latino' ; 8 - 'Not reported' ; 9 - 'Unknown' Optional Health_Insuranc e array of number N 1,2,3,4,5 Select all that apply: 1 - 'Medicare'; 2 - 'Medicaid'; 3 - 'Private insurance'; 4 - 'Self pay '; 5 - 'Unknown ' Optional Smoking status Smoking_Status string N 1,2,3,4,9 Select one: 1 - 'Current smoker'; 2 - 'Former smoker' ; 3 - 'Never smoker' ; 4 - 'Smoker, current status unknown'; 9 - 'Unknown if ever smoked' Required Number of packs-year of smoking Number_Of_Pac ks_Year_Smokin g number N between 1 and 999 17 18 19 20 21 22 Otherwise, this field should be left blank If Smoking_Status is 1, 2 or 4 then Number_Of_Packs_Year_Sm oking is required; otherwise, this field should be left blank. June 29, 2017 51 LCSR User Guide Number of years since quit Number_Of_Yea rs_Since_Quit number N between 1 and 99 If Smoking_Status is 2 then Number_Of_Years_Since_Qu it is required. 23 24 25 26 27 28 Otherwise, this field should be left blank. Did physician provide smoking cessation guidance to patient? Is there documentati on of shared decision making? Did_Physician_Pr ovide_Guidance string N N,Y,U Select one: N - No; Y - Yes; U - 'Unknown' Required Doc_Of_Shared_ Dec_Making string N N,Y,U Select one: N - No; Y - Yes; U - 'Unknown' Required Patient height (inches) Patient weight (lbs) Other comorbiditie s listed on patient record that limit life expectancy Patient_Height string N 0-99 0 - Unknown 99 - Unknown Required Patient_Weight string N 0-999 Required Patient_Other_C omorbidities array of number N 0,1,2,3,4,5,6,7,8 0 - Unknown 999 - Unknown Select all that apply: 0 - 'COPD' ; 1 - 'Emphysema'; 2 - 'Pulmonary fibrosis'; 3 - 'Coronary artery disease'; 4 - 'Congestive heart failure '; 5 - 'Peripheral vascular disease'; 6 - 'Lung cancer'; 7 - 'Cancer other than lung cancer '; 8 - 'Other, please specify' Other comorbiditie s, other specify Patient_Other_C omorbidities_Sp ec string N max length is 255 characters Optional If Patient_Other_Comorbidities is 8, then Patient_Other_Comorbidities _Spec is applicable; 29 Cancer related history Cancer_Related_ History 30 June 29, 2017 Optional array of number N 0,1,2,3,4,5,6,7 Select all that apply: 0 - Prior history of lung cancer 1 - lymphoma 2- H&N cancer 3 - bladder cancer 4 - esophageal cancer 5 - Pulmonary fibrosis 6 - Other cancer, please specify 7- Other otherwise, this field should be left blank Optional 52 LCSR User Guide 31 Cancer related history, other specify Cancer_Related_ History_Other_S pec string N max length is 255 characters Optional If Cancer_Related_History is 6, then Cancer_Related_History_Oth er_Spec is required; N otherwise, this field should be left blank Required Radiologist (reading) NPI Radiologist_Read ing_NPI string 10-digits Ordering practitioner NPI Ordering practitioner first name Ordering practitioner last name Exam date Ordering_Practiti oner_NPI string N 10-digits Required Ordering_Practiti oner_First_Name string N max length is 50 characters Optional Ordering_Practiti oner_Last_Name string N max length is 50 characters Optional Exam_Date string Y format mm/dd/yyyy Required Signs or symptoms of lung cancer Indication of exam Signs_Or_Sympt oms_Of_Lung_C ancer Indication_Of_Ex am string N Y, N string N 1,2 Reading radiologist must exist in the NRDR Physician dictionary. 32 33 34 35 36 37 Select one: Y - Yes; N - No Select one: 1 - 'Baseline scan' ; 2 - 'Annual screen' 38 40 41 string N 1,2 CT scanner manufacture r CT scanner model CTDlvol (mGy) CT_Scanner_Ma nufacturer string N max length is 50 characters Required CT_Scanner_Mo del CTDIvol string N max length is 50 characters Required string N format nnn.nn DLP (mGy*cm) DLP Tube current-time (mAs) Tube voltage (kV) Scanning time (s) Tube_Current_Ti me string N format nnn 0<= Tube_Current_Time <= 999 Optional Tube_Voltage string N format nnn 0<= Tube_Voltage <= 999 Optional Scanning_Time string N format nnn.nn 0.01<= Scanning_Time <= 999.99 Optional 0.01<= CTDlvol <= 999.99 Required Whole number is acceptable. Decimal place is optional, if provided limit to 2 digits. string N format nnnn.nn 0.01<= DLP <= 9999.99 Required Whole number is acceptable. Decimal place is optional, if provided limit to 2 digits. 43 45 otherwise, this field should be left blank Required Modality 42 44 If Signs_Or_Symptoms_Of_Lun g_Cancer is 'N', then Indication_Of_Exam is required; Modality 39 Select one: 1 - 'Low dose chest CT' ; 2 - 'Routine chest CT' Cannot be a future date Required 46 June 29, 2017 Whole number is acceptable. Decimal place is optional, if provided limit to 2 digits. 53 LCSR User Guide Scanning volume (cm) Scanning_Volum e string N Pitch Pitch string N Reconstructe d image width (nominal width of reconstructe d image along z-axis) (mm) CT exam result by Lung-RADS category Reconstructed_I mage_Width string N CT_Exam_Result _Lung_RADS string Reason for recall Reason_For_Rec all string format nnn.nn 0.01<= Scanning_Volume <= 999.99 Optional format nn.nnn 0.000<= Pitch <= 99.999 Optional format n.nn 0.01<= Reconstructed_Image_Width <= 9.99 Required 47 48 49 N 0,1,2,3,4A,4B,4X 50 N I,N,M,E,OBa 51 52 Whole number is acceptable. Decimal place is optional, if provided limit to 2 digits. Whole number is acceptable. Decimal place is optional, if provided limit to 2 digits. Required Select one: 0 - 'recalls (incomplete screen)'; 1 - 'normal, continue annual screening'; 2 - 'benign appearance or behavior, continue annual screening'; 3 - '6 month CT recommended'; 4A - '3 month CT recommended; may consider PET/CT'; 4B - 'Additional diagnostics and/or tissue sampling recommended'; 4X - 'Additional diagnostics and/or tissue sampling'; Select one: I - 'Incomplete coverage' ; N - 'Noise' ; M - 'Respiratory motion'; E - 'Expiration'; OBa - 'Obscured by acute abnormality' If CT_Exam_Result_Lung_RADS is 0, then Reason_For_Recall is required; otherwise, this field should be left blank. Other clinically significant or potentially significant abnormalitie s - CT exam result modifier S CT_Exam_Result _Modifier_S string N Y, N Select one: Y - Yes; N - No Required What were the other findings What_Were_The _Other_Findings array of number N 0,1,2,3,4 Select all that apply: 0 - 'Aortic aneurysm' ; 1 - 'Coronary arterial calcification moderate or severe'; 2 - 'Pulmonary fibrosis ' ; 3 - 'Mass (check neck, mediastinum, liver, kidneys, other) '; 4- 'Other interstitial lung disease'; Optional 53 June 29, 2017 If CT_Exam_Result_Modifer_S is 'Y', then What_Were_Other_Findings is required; otherwise, this field should be left blank 54 LCSR User Guide Mass, specify Mass_Spec string N max length is 255 characters Optional If What_Were_The_Other_Fin dings is 3, then Mass_Spec is required; 54 Other interstitial lung disease Other_Int_Lung_ Disease string N 1,8,9 55 56 57 58 Other interstitial lung disease, specify Other_Int_Lung_ Disease_Spec string N Select one: 1 -'UIP/IPF' ; 8 - 'ILD, other, please specify '; 9 - 'ILD, unknown'; otherwise, this field should be left blank Optional If What_Were_The_Other_Fin dings is 4, then Other_Int_Lung_Disease is applicable; otherwise, this field should be left blank If Other_Int_Lung_Disease is 8, then Other_Int_Lung_Disease_Spe c is required; max length is 255 characters otherwise, this field should be left blank Required Prior history of lung cancer - CT exam result modifier C CT_Exam_Result _Modifier_C string N other findings Select one: N - No; Y - Yes; U - 'Unknown' Year since prior diagnosis of lung cancer Education level Years_Since_Prio r_Diagnosis string N format: nn 1 <= Years_Since_Prior_Diagnosis <= 99 Optional Education_Level string N 1,2,3,4,5,6,7,8,99 Select one: 1 - '8th grade or less' ; 2 - '9-11th grade' ; 3 - 'High school graduate or high school equivalency' ; 4 - 'Post high school training, other than college' ; 5 - 'Associate degree / some college' ; 6 - 'Bachelor’s degree'; 7 - 'Graduate or Professional school' ; 8 - 'Other, specify'; 99 - 'Unknown / I prefer not to answer' Optional Education level, other Education_Level _Other_Spec string N max length is 255 characters 59 Optional If Education_Level is 8, then Education_Level_Other_Spec is required; 60 otherwise, this field should be left blank 61 Radon exposure documented high exposure levels Radon_Exposure June 29, 2017 string N Y, N Select one: Y - Yes; N - No Optional 55 LCSR User Guide 62 63 64 Occupational exposures to agents that are identified specifically as carcinogens targeting the lungs History of cancers that are associated with an increased risk of developing a new primary lung cancer History of cancers that are associated with an increased risk of developing a new primary lung cancer other smokingrelated cancers, specify Lung cancer in firstdegree relative (mother, father, sister, brother, daughter or son with history of lung cancer) Family history of lung cancer, other than first‐degree relative Occupational_Ex posures array of number N 0,1,2,3,4,5,6,7 Select all that apply: 0 - 'Silica'; 1 - 'Cadmium'; 2 - 'Asbestos'; 3 - 'Arsenic'; 4 - 'Beryllium' ; 5 - 'Chromium '; 6 - 'Diesel fumes'; 7 - 'Nickel ' Optional History_Of_Canc ers array of number N 0,1,2,3,4 Select all that apply: 0 - 'Prior lung cancer'; 1 - 'Lymphoma' ; 2 - 'Head and neck; 3 - 'Bladder cancer '; 4 - 'Other smoking-related cancers, specify ' Optional Other_Smoking_ Cancers_Spec string N max length is 255 characters Optional If History_Of_Cancers is 4, then Other_Smoking_Cancers_Spe c is required; otherwise, this field should be left blank Lung_Cancer_In_ First_Deg_Rel string N N,Y,U Select one: N - No; Y - Yes; U - 'Unknown' Optional Lung_Cancer_Ot her_First_Deg_R el string N N,Y,U Select one: N - No; Y - Yes; U - 'Unknown' Optional COPD COPD string N Y, N Optional Pulmonary fibrosis Pulmonary_Fibro sis string N Y, N 68 Second_Hand_S moke_Exposure string N N,Y,U 69 Second hand smoke exposure Select one: Y - Yes; N - No Select one: Y - Yes; N - No Select one: N - No; Y - Yes; U - 'Unknown' Date of follow-up Date_Of_Follow_ Up string Y format mm/dd/yyyy 65 66 67 Optional Optional Follow-up Data (optional) 70 June 29, 2017 Required when submitting Follow-Up for a case; cannot 56 LCSR User Guide be a future date Follow-up diagnostic Follow_Up_Diag nostic string Y 1,2,3,4,5,6,7 Follow-up diagnostic other, specify Follow_Up_Diag nostic_Other_Sp ec string N max length is 255 characters 71 72 Tissue diagnosis Tissue_Diagnosis string N 1,2,3,4,5,6,7 73 74 Tissue diagnosis method Location from which sample was obtained Tissue_Diagnosis _Method Location_From_S ample_Obtained 75 June 29, 2017 string string N N 1,2,3 0,1,2,3,4,5,6,7,8,9,10,11 Select one: 1 -'Low dose chest CT'; 2 - 'Routine chest CT' ; 3 - 'PET/CT' ; 4 - 'Bronchoscopy' ; 5 - 'Non-surgical biopsy' ; 6 - 'Resection' ; 7 - 'Other, specify ' Required If Follow_Up_Diagnostic is 7, then Follow_Up_Diagnostic_Other _Spec is required; Select one: 1 - 'Benign'; 2 - 'Malignant - invasive lung cancer' ; 3 - 'Malignant - Minimally invasive lung cancer' ; 4 - 'Malignant - NON-lung cancer' ; 5 - 'Malignant adenocarcinoma in situ' ; 6 - 'Premalignancy - atypical adenomatous hyperplasia' ; 7 - 'Non-diagnostic' Select one: 1 - 'Percutaneous' ; 2 - 'Bronchoscopic' ; 3 - 'Surgical' Select one: 0 - 'Left Hilum '; 1 - 'Lingula of the Lung '; 2 - 'Left Lower Lobe of Lung '; 3 - 'Left Upper Lobe of Lung '; 4 - 'Right Hilum'; 5 - 'Right Lower Lobe of Lung '; 6 - 'Right Middle Lobe of Lung ' ; 7 - 'Right Middle and Right Lower Lobes of Lung '; 8 - 'Right Upper and Right Middle Lobes of Lung '; 9- 'Right Upper Lobe of Lung'; 10 - 'Other'; 11 - 'Unknown' otherwise, this field should be left blank If Follow_Up_Diagnostic is 4, 5 or 6 then Tissue_Diagnosis is required; If Follow_Up_Diagnostic is 7 then Tissue_Diagnosis is optional; otherwise, this field should be left blank If Tissue_Diagnosis is populated, then Tissue_Diagnosis_Method is required; otherwise, this field should be blank If Tissue_Diagnosis is populated, then Location_From_Sample_Obt ained is required; otherwise, this field should be blank 57 LCSR User Guide Location other, specify Location_Other_ Spec string N max length is 255 characters If Location_From_Sample_Obt ained is 10, then Location_Other_Spec is required; 76 otherwise, this field should be left blank Histology Histology string N 1,2,3,4 77 Histology Non-small cell lung cancer Histology_Non_S mall_Cell_LC string N 1,2,3,4,5,6 78 79 Other nonsmall cell lung cancer histology, specify Stage Clinical or pathologic? Other_Non_Smal l_Cell_LC_Histolo gy_Spec Stage_Clinical_O r_Pathologic string number N N Select one: 1 - 'Non-small cell lung cancer' ; 2 - 'High grade neuroendocrine tumor (small cell lung cancer)' ; 3 - 'Low grade neuroendocrine tumor (carcinoid)'; 4 - 'Intermediate grade neuroendocrine tumor (Atypical carcinoid)' Select one: 1 - 'Invasive adenocarcinoma' ; 2 - 'Squamous cell carcinoma' ; 3 - 'Adenosquamous cell carcinoma'; 4 - 'Undifferentiated or poorly differentiated carcinoma' ; 5 - 'Large cell carcinoma' ; 6 - 'Other, specify' max length is 255 characters 1,2,9 If Tissue_Diagnosis is 2, 3, or 5 then, Histology is required; If Tissue_Diagnosis is 4 then, Histology is applicable but optional; otherwise, this field should be blank Required & Conditional If Histology is 1, then Histology_Non_Small_Cell_L C is required; otherwise, this field should be blank If Histology_Non_Small_Cell_L C is 6, then Other_Non_Small_Cell_LC_Hi stology_Spec is required; Select one: 1 - 'Clinical' ; 2 - 'Pathologic' ; 9 - 'Unknown' 80 otherwise, this field should be left blank If Tissue_Diagnosis is 2, 3, or 5 then, Stage_Clinical_Or_Pathologic is required; If Tissue_Diagnosis is 4 then, Stage_Clinical_Or_Pathologic is applicable but optional; otherwise, this field should be blank Overall stage Overall_Stage 81 June 29, 2017 string N IA,IB,IIA,IIB,IIIA,IIIB,IV, Unknown Select one: IA IB IIA IIB IIIA IIIB IV Unknown If Tissue_Diagnosis is 2, 3, or 5 then, Overall_Stage is required; If Tissue_Diagnosis is 4 or 7 then, Overall_Stage is applicable but optional; otherwise, this field should be blank 58 LCSR User Guide T status T_Status string N TX,T1a,T1b,T2a,T2b,T3,T4,99 82 N status N_Status string N NX,N0,N1,N2,N3 83 M status M_Status 84 June 29, 2017 string N MX,M0,M1a,M1b Select one: Tx T1a T1b T2a T2b T3 T4 99 Optional & Conditional Select one: NX N0 N1 N2 N3 Optional Select one: MX M0 M1a M1b M1c if Tissue_Diagnosis is populated then T_Status is applicable; otherwise, this field should be blank if Tissue_Diagnosis is populated then N_Status is applicable; otherwise, this field should be blank Optional if Tissue_Diagnosis is populated then M_Status is applicable; otherwise, this field should be blank 59 LCSR User Guide THIS PAGE INTENTIONALLY LEFT BLANK June 29, 2017 60
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