Attachment 3b CCDE Data Users Manual
Attachment 3b CCDE Data Users Manual.docx
Colorectal Cancer Screening Program
Attachment 3b CCDE Data Users Manual
OMB: 0920-0745
ATTACHMENT 3b. CCDE Data Users Manual
Form Approved OMB# 0920-0745 Expiration XX/XX/XXXX
Colorectal Clinical Data Elements (CCDE)
DATA USER'S MANUAL
for the
Colorectal Cancer Control Program (CRCCP)
CCDE Version 1.00 March 2010
Centers for Disease Control and Prevention National Center for Chronic Disease Prevention and Health Promotion Division of Cancer Prevention and Control
Public reporting burden of this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, GA 30333.
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This manual was written by the Centers for Disease Control and Prevention (CDC) to centralize the information needed to produce data for the Colorectal Cancer Control Program (CRCCP). One goal of the manual is to provide the technical information necessary for the grantees to produce the Colorectal Cancer Clinical Data Elements (CCDEs). Another goal is to highlight the technical assistance provided to the grantees by the CDC and the clinical data contractor, Information Management Services, Inc. (IMS). A common goal of the CDC and the grantees is to produce data that are timely, complete, and of high quality so that we can better serve the clients targeted by the program.
The intended audience for this manual is the grantee staff responsible for the collection and aggregation of the CCDE data. It is divided into 4 chapters as follows:
Chapter 1 Data Submission
This chapter contains the dates that the Colorectal Cancer Clinical Data Elements (CCDEs) are to be submitted to IMS, along with the technical requirements for submission.
Chapter 2 Colorectal Cancer Clinical Data Elements (CCDEs)
This chapter includes a general introduction to the CCDEs and detailed information about each CCDE data item.
Chapter 3 Registry Linkage
This chapter provides variable definition tables that outline each of the collaborative stage variables collected in the CCDEs.
Chapter 4 References
This chapter contains the appendices to the manual including the CCDE Submission Narrative Guidelines, the CDC Race and Ethnicity Code Set, the CCDE Data Definition Table, and a Glossary of Terms.
Chapter 1 CCDE Data Submission
What 1
When 1
How 2
Submission Narrative Standards 3
CCDE Data Submission Process 4
Chapter 2 Colorectal Cancer Clinical Data Elements (CCDEs)
Introduction to the CCDE Chapter 9
Understanding CCDE Data
Colorectal Cancer Clinical Data Elements 13
CCDE Field Descriptions
Section 1 Client and Record Identification 19
Section 2 Demographic Information 24
Section 3 Screening History 35
Section 4 Assessed Risk 36
Section 5 Screening Adherence 41
Section 6 Screening and Diagnostic Tests Performed 44
Section 7 Pathology from all Endoscopy Tests Performed 101
Section
8 Diagnosis Information for Surgeries Performed to
Complete Diagnosis 108
Section 9 Final Diagnosis 111
Section 10 Treatment Information 125
Section 11 Registry Information for Cancer/High Grade Dysplasia 130
Section 12 Record Information 141
Chapter 3 Registry Linkage
CCDE Item 11.03 Registry Histologic type 147
CCDE Item 11.04 Registry behavior 146
CCDE Item 11.05 Registry primary site 156
CCDE Item 11.06 Registry CS-derived SS2000 160
CCDE Item 11.07 Registry CS-derived AJCC stage group 161
CCDE Item 11.08 Registry CS extension 162
CCDE Item 11.09 Registry CS lymph nodes 168
CCDE Item 11.10 Registry CS mets at diagnosis 171
Chapter 4 References
Appendix A – CCDE Submission Narrative Guidelines 178
Appendix B – CDC Race and Ethnicity Code Set 184
Appendix C – CCDE Data Definition Table 190
Appendix D – Glossary of Terms 218
CHAPTER 1
What: CCDE data are submitted semi-annually to IMS. Each CCDE submission will include cumulative data from the beginning of screening through the submission’s screening cut-off date, which is 2.5 months prior to the due date. Do not include records dated after the screening cut-off date. The 2.5 month lag time between the cut-off date and the reporting of the CCDE data will allow time to collect and perform quality control on these data. Submitted records may have incomplete data that will be updated on a subsequent submission. Each submission dataset will replace the previous submission in its entirety.
Screening Cut-off Date: CCDE Item 5.1 (Initial test appointment date, or date fecal kit distributed) should be used as the screening cut-off date to determine if the record should be included in the submission. Item 5.1 represents the date that screening was initiated for clients enrolled in the program, regardless of whether testing was completed or not. Refer to Chapter 2 for more information on tracking screening adherence in the CCDEs.
For example, if the data are due to IMS on 09/15/2010, the data should cover all records indicating procedures initially scheduled or fecal kits distributed (CCDE Item 5.1) from the onset of the screening program through 06/30/2010.
Inclusion of records:
The CCDE data file should contain records on all clients who were enrolled in the Colorectal Cancer Control Program (CRCCP) and who received services paid for using CDC funds. This includes clients who are determined to be eligible and are scheduled for screening procedures or given a take-home fecal kit, regardless of whether they return the kit or adhere to screening.
If authorized by CDC, records of clients screened using other non-CRCCP funding sources may be reported, but should be limited to publically funded screening of a similar eligible population.
When: CCDE data are submitted to IMS according to the schedule below.
All files should be received by IMS by close of business on the due date. If the submission due date falls on a weekend or holiday, then the data should be received by the close of business on the first business day after the submission due date.
Submission Due |
Screening Cut-off Date |
09/15/2010 |
06/30/2010 |
03/15/2011 |
12/31/2010 |
09/15/2011 |
06/30/2011 |
03/15/2012 |
12/31/2011 |
09/15/2012 |
06/30/2012 |
03/15/2013 |
12/31/2012 |
How: When a CCDE submission is due, the CCDE data must be extracted from your client database and put into the standardized CCDE format. The CCDE file consists of fixed length records in an ASCII file format. In Version 1.00 of the CCDE data file format, each record consists of 526 columns which includes 524 columns for reporting screening, diagnosis, treatment and Cancer Registry information and a 2 character end-of-record delimiter in the form of a "carriage return-line feed". A detailed description of the CCDE items in each record is included in Chapter 2.
The CCDE file must be submitted electronically using the secure www.CRCCP.org Web site. IMS and the CDC require the use of compression software such as WinZip or Gzip to compress the CCDE data file prior to submission.
It is necessary for each grantee to name their CCDE file using the following naming convention:
YP -> Your Program’s abbreviation (e.g. AL = Alabama)
MM -> Month of submission due date, with leading zeroes (09 = September)
YY -> Year of submission due date (10 = 2010)
VVV -> CCDE version number (100 = CCDE version 1.00)
For example, the compressed file that Alabama submits to IMS for the September 2010 submission will have the following name: AL0910100.zip or AL0910100.gz. The WinZip or Gzip file would contain an ASCII file called AL0910100.txt. Please do not include other files, such as the Submission Narrative or other supporting documents in the CCDE zip file. Those files should be submitted separately.
Updates and Corrections: For each CCDE submission, grantees are required to submit a cumulative data set through the screening cut-off date. Therefore, if any changes or updates to a particular record occur between CCDE submissions, these changes will be incorporated within the next CCDE data file.
CCDE Edits Program: IMS will develop an edits program for grantee use that should be used to evaluate the CCDE data file prior to each CCDE submission. The edits program will perform basic validation routines and report on invalid values, missing fields, and cross-field edits. The edits program and further instructions on its use will be provided via the www.CRCCP.org Web site.
Submission Narrative: A Submission Narrative should be provided with each data submission. CCDE data are regularly reviewed by the CDC, IMS, and grantee staff. Often questions arise from these reviews, and sometimes these questions lead to modifications to the CCDE data and/or its processing. The Submission Narrative provides a structured way for grantees to report responses to these questions or to report the details of data modifications.
The Submission Narrative has two sections. Section I is where responses to Action Items (written questions from the CDC and IMS based on a data review conference call) are provided. Section II is comprised of five standard questions that require grantees to do a prospective review of their CCDE data prior to submitting it to IMS. A hard copy of the CCDE Submission Narrative Guidelines can also be located in Appendix A. An electronic copy may be found on the www.CRCCP.org Web site. A response to each of the five standard questions is required in the Submission Narrative, even if that response is “N/A - Not applicable”. It is expected that grantees should have the capability to review and manage their data, and should not rely solely on the CCDE submission feedback provided by CDC and IMS.
Submission Narrative Standards: The narrative file should be created in *.doc or *.pdf format and submitted using the following naming convention:
YPMMYY-NARRATIVE
YP = Your Program’s abbreviation (e.g. AL = Alabama)
MM = Month of submission due date, with leading zeroes (09 = September)
YY = Year of submission due date (10 = 2010)
For example, the submission narrative file that Alabama submits to IMS in *.doc format for the September 2010 CCDE submission will have the following name: AL0910-narrative.doc. The narrative file should be submitted separately from the CCDE data zip file.
IMS and the CCDEs: Once these CCDE data are received at IMS they are reviewed and validated. Using SAS, listings and printouts of sample records for each grantee are produced to check data quality. A SAS analysis file is created that attempts to clean up invalid data and eliminate duplicate screening results. A series of reports are then generated to assess the completeness and accuracy of these data, as well as to document the percentage of abnormal screening results that have complete diagnostic and treatment data. These data are assessed to determine progress in meeting program goals.
Semi-annual CCDE Data Submission Process
Grantees
CCDE
file (Cumulative
data)
T
Export
Submission
Narrative
IMS www.crccp.org
Web site
Validation
and Analysis
National
and Grantee Specific Reports
Reports,
data reviews, and conference calls with CDC/IMS
here
are six steps in the CCDE Submission Process that repeat
semi-annually:
CCDE Submission Process |
||
Semi-annual Timeline |
Steps |
|
March
|
September
|
Grantee programs prepare and submit a CCDE file and Submission Narrative on March 15 and September 15.
|
May |
November |
IMS creates an analysis file that is provided to the CDC, within a specified time frame, for review and approval.
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June
|
December
|
IMS generates feedback reports which are reviewed and posted to the www.crccp.org Web site within a specified time frame. |
July |
January |
CCDE Data Review Calls are held within approximately one month of the posting of the feedback reports. Data Notes, prepared by the IMS Technical Consultant, are posted three business days in advance of the scheduled call.
|
July |
January |
The IMS Clinical Data Consultant sends Action Items requiring investigation or response to the Program Consultant and the Grantee within 5 business days after a data call. The CDC Program Consultant communicates a summary of the data review in a letter to the Grantee.
|
August |
February |
The Grantee investigates Action Items and completes responses in Sections I and II of the Submission Narrative and submits to IMS with the next CCDE submission. |
Software Selection: Each grantee needs to identify computer software to use for data management. The decision must balance the unique needs of the program, the cost of developing an in-house system, as well as the suitability of available software. CDC provides an optional use database management system called Cancer Screening and Tracking (CaST) System, developed to track clients screened for cancer and to generate the data items required for CCDE reporting. Other options include developing a custom in-house system, adding to an existing health system in your Program, or purchasing software from vendors that have developed other CRCCP systems.
If at any time a grantee chooses to convert their existing data system to a different software package, please notify your CDC Program Consultant and IMS Clinical Data Consultant of your plans and timeline. It is also strongly recommended that a test data submission be sent to IMS for review once the conversion process is completed and validated. Grantees should wait for feedback on the test data submission prior to implementation of the new data system. The test submission should be done well in advance of a CCDE submission due date. The IMS Clinical Data Consultant should be notified prior to sending the test data file.
Similarly, it is strongly recommended that revised data collection forms should be sent to CDC and IMS for data management and clinical review before your program finalizes and implements the forms.
CHAPTER 2
Colorectal Cancer Clinical Data Elements (CCDEs)
Introduction to the CCDE Chapter
The purpose of this chapter is to provide the grantees with the information necessary to collect the CCDE data.
Understanding the CCDE data
This section of the chapter provides information regarding the structure of the CCDEs, the definition of a screening cycle, information about collecting and reporting Race and Hispanic Origin data, creating a unique client identification number, and details regarding data conventions used in reporting CCDE items.
CCDE Field Descriptions
This section provides a detailed description of each CCDE data item. This is the format that must be followed for the CCDE data submissions submitted to CDC.
Note: CDC distributed a draft of the CCDE data set to grantees on 10/30/2009. The final version of the CCDE data set to be used by grantees was subsequently distributed on 12/02/2009. The CCDE Field Descriptions in this User’s Manual reflect the final CCDE data set.
The www.crccp.org Web site contains documentation of the revisions made between the draft CCDE data set and the final version of the CCDE data set.
Colorectal Cancer Clinical Data Elements
The Colorectal Cancer Clinical Data Elements (CCDEs) are a set of standardized data elements developed to ensure that consistent and complete information on client demographic characteristics, screening history, risk factors, screening and diagnostic tests, diagnosis, staging and treatment are collected on clients screened or diagnosed with program funds. These are the data items that are necessary for the grantees and the CDC to manage and evaluate the clinical component of the Colorectal Cancer Control Program. Grantees may collect additional data for local use (not to be reported to the CDC) if they choose. The CCDEs are collected for each screening event for each client, then computerized, converted into a standardized format, and transmitted to IMS.
A CCDE cycle is reported in one CCDE record. For clients that adhere to testing, a CCDE cycle begins with an initial colorectal cancer screening test and continues through any additional tests or procedures required for diagnostic evaluation following an abnormal or incomplete test, and ends when a final diagnosis is determined and treatment is initiated, if indicated.
Tracking Screening Adherence
Non-adherent clients that did not participate in screening are also reported in the CCDEs to track screening adherence across the program, which is a high priority for CDC. Non-adherent clients are those who initiated testing by receiving a fecal kit or appointment for a procedure, but did not follow through with testing. Each grantee program develops a policy and procedure to determine the timeframe and criteria to administratively close out a record as non-adherent. Refer to Data Items 5.1 and 5.2.
The CCDEs consist of twelve sections. Each section contains specific variables to provide the CDC with detailed information about the client’s screening cycle.
Section 1: Client and Record Identification
This section identifies your Program and contains client IDs (to uniquely identify and track clients) and record IDs (to identify one record among many for a unique client ID). It must be completed for each client and each CCDE record for that client.
Section 2: Demographic Information
This section contains demographic information about clients. The information collected in this section must be self-reported by the clients. This information must be completed for each client and each CCDE record for that client.
Section 3: Screening History
This section contains information regarding previous colorectal screening tests. The information collected in this section can be self-reported by the client, or can come from information documented in the client’s medical record. Medical record information is preferred if available. This information must be completed for each client and each CCDE record for that client.
Section 4: Assessed Risk
This section contains risk factor information, such as previous diagnoses of precancerous polyps or colorectal cancer. It also captures information about family history of colorectal cancer and current symptoms experienced by the client. The information collected in this section can be self-reported by the client, or can come from information documented in the client’s medical record. Medical record information is preferred if available. This information must be completed for each client and each CCDE record for that client.
Section 5: Screening Adherence
This section contains information on the client’s adherence to screening once initiated with an appointment made or a fecal kit provided. Information is collected about the initial test appointment date and whether or not the test was performed. It includes information about fecal kit distribution and return. This section must be completed for each client and each CCDE record for that client.
Section 6: Screening and Diagnostic Tests Performed
This section contains information about the types of screening or diagnostic tests received by a client within each screening cycle. This information must be completed for each CCDE record where Section 5 (Screening Adherence) indicates “Test Performed”.
Section 7: Pathology from all Endoscopy Tests Performed
This section contains data regarding histology of any polyps or lesions discovered during the screening cycle, along with number and size of any adenomatous polyps or lesions. This section must be completed anytime the client had a biopsy or polypectomy performed during one of the tests in Section 6.
Section 8: Diagnosis Information for Surgeries Performed to Complete Diagnosis
This section contains data regarding the date of surgery and histology from the surgical resection. This section should be completed anytime the client has “surgery recommended to complete the final diagnosis” after one of the tests in Section 6.
Section 9: Final Diagnosis
This section contains data regarding the final diagnosis for a screening cycle, any complications of endoscopy or DCBE experienced by the client, and the recommended test to begin the next cycle. This section should be completed for each CCDE record with at least one test performed (Section 6).
Section 10: Treatment Information
This section collects treatment information for clients with a final diagnosis of cancer.
Section 11: Registry Information for Cancer/High Grade Dysplasia
This section collects staging information obtained after linking with the central cancer registry for diagnoses of cancer and high grade dysplasia.
Section 12: Record Information
This section includes the CCDE version for data reported and an end of record mark.
Race and Hispanic Origin
Federal Programs are required to use standards defined by the U.S. Office of Management and Budget (OMB) for the classification of race and ethnicity data. Additional information is available on the OMB Web site at http://www.whitehouse.gov/omb.
The race codes collected in the CCDEs model those required by the OMB. However, grantees may expand these categories during data collection to include racial subgroups that are represented in the local population if they choose. For example, a grantee may be established in an ethnic neighborhood where the clients may not feel that the CCDE category of ‘White’ is appropriate. In this instance, expanding the category to include ‘Egyptian' or ‘Israeli’ may promote a more complete collection of race information. In these instances, the data system would then collapse these categories into ‘White’ prior to the CCDE submission to the CDC.
The same would hold true for the collection of Hispanic or Latino origin. If a grantee finds that the Race fields are frequently left blank when Hispanic or Latino origin is reported as “Yes”, then it may be more advantageous to expand the Race categories to include ‘White – Hispanic’, ‘White – Non-Hispanic’, etc. These categories could then be expanded to report Hispanic Origin and Race prior to the CCDE submission to the CDC.
An expanded list of the CDC Race and Ethnicity Code Set is included in Appendix B to assist grantees in collapsing more specific race concepts into the standard race code set.
The client identification number used in the CCDEs must be unique and consistent throughout the entire data system. It is important, for program purposes, to be able to track clients over time. A client identification number which is unique only to a clinic is not acceptable because it cannot track a client between clinics. Grantees may not have the capability to assign the same unique identifier to a client who changes clinics. In these programs, matching is routinely done to identify the relatively small number of clients who change clinics. Matching can be done using date of birth, name (first, last, and maiden), and Social Security Number. Using a combination of these items assures a greater number of accurate matches.
Completely numeric identifiers are preferred; however, the CCDEs allow the use of alpha-numeric client identifiers, if necessary. Confidentiality is of the utmost importance. The CDC does not want an identification number that could be used to link the CCDEs to other databases. While a Social Security Number could be used, you must encode it prior to submission to the CDC. See the item description on Client ID for encoding procedures.
These are the general data conventions that apply to the CCDE data. However, the specific information on each field should be followed for a CCDE submission.
Dates: All dates are entered in the form MMDDYYYY. For example, January 6, 1942 should be reported as 01061942. If any part of the date is unknown, blank fill just that part. For example, if the month and year are known, but the day is not, blank fill just the day
(e.g., 01 1942). Date fields may not be missing the year value.
Alphanumeric Fields: Alphanumeric or character data must be left-justified. In a left-justified field, the field value is placed so that the first character of the value is in the first position of the field. For example, Item 1.2 (Client Identifier) is left-justified in the CCDE file. The starting and ending positions are columns 4 through 18. If the Client Identifier is 1234, then “1234“ should be placed in columns 4 through 7 and columns 8 through 18 would be filled with blanks as shown here: “1234 “.
Numeric Fields: Numeric fields are right-justified. In a right-justified field, the field value is placed so that the last character of the value is in the last position of the field. For example, Item 1.3 (Record Identifier) is a 6-digit numeric code and it is right justified. The starting and ending positions are 19 through 24. If the record identifier is 1, then “1” should be placed in column 24 and columns 19 through 23 should be blank, as shown here: “ 1”. Numeric fields may also be reported using leading zeroes, as shown here: “000001”. Grantees are asked to be consistent in how numeric values are placed.
Blank Filled Fields: A blank filled field is filled with blank characters. If the field has a length of six and it is appropriate to blank fill the field, then it should contain six blank characters. It is only appropriate to blank fill a field when it is indicated in the item description. A blank field should not be used as a substitute for an "unknown" response if a valid "unknown" code exists.
PURPOSE: To indicate the unique identifier for the grantee program.
LENGTH: 3
FIELD LOCATION: 1-3
TYPE: Numeric – right justify. Include leading zeroes.
SKIP PATTERN: This field should always be completed.
CONTENTS: 001 = Alabama (AL)
004 = Arizona (AZ)
006 = California (CA)
008 = Colorado (CO)
009 = Connecticut (CT)
010 = Delaware (DE)
012 = Florida (FL)
019 = Iowa (IA)
023 = Maine (ME)
024 = Maryland (MD)
025 = Massachusetts (MA)
027 = Minnesota (MN)
030 = Montana (MT)
031 = Nebraska (NE)
033 = New Hampshire (NH)
035 = New Mexico (NM)
036 = New York (NY)
041 = Oregon (OR)
042 = Pennsylvania (PA)
046 = South Dakota (SD)
049 = Utah (UT)
053 = Washington (WA)
Tribal Program Codes
090 = Arctic Slope (AC)
092 = Southcentral Foundation (SO)
098 = South Puget Intertribal Planning Agency (SP)
099 = Alaska Native Tribal Health Consortium (AN)
EXPLANATION: The state FIPS codes are the Federal Information Processing Standard codes developed by the National Bureau of Standards. The tribal program codes are codes assigned by the CDC to be used by the tribal programs in lieu of state FIPS codes.
EXAMPLE: For Arizona: 004
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 1.2: Client identifier
PURPOSE: To indicate a system-generated identification number for each client that will be consistent for the client throughout the database.
LENGTH: 15
FIELD LOCATION: 4-18
TYPE: Alphanumeric (no special symbols) – left justify, case sensitive.
SKIP PATTERN: This field should always be completed.
CONTENTS: A fifteen-digit alphanumeric code. The client identifier must be unique and constant for each client in your database in order to track each client over time. A client identifier that is unique only to a specific clinic or location is not acceptable because it cannot track the client between locations. Completely numeric client identifiers are preferred; however, the CCDEs allow the use of alphanumeric client identifiers if you find it necessary. If alphabetic characters are included in the Client identifier field, they must be entered consistently in uppercase or lowercase for all records for each client.
Confidentiality is of the utmost importance. The CDC does not want a client identifier that could be used to link CCDE records to other databases. Certain identification numbers such as Social Security Numbers lack this privacy. If Social Security Numbers are used, or any other number which has linking capabilities, then the client identifier must be encoded. The CDC does not want to know the encoding scheme used by your program. However, your program should derive an encoding scheme which you can decode to the original client identifier in the event that a problem is found. The use of partial names and/or dates is also not recommended.
We provide the following suggestions and an example encoding procedure which we hope you will find helpful. Digit rotation and nines-complement are two methods which, when combined, can be used as an effective encoding scheme. Digit rotation is simply rotating a set of digits either left or right. The nines-complement of a number is nine minus the number, i.e. the nines-complement of 2 is 7, the nines-complement of 5 is 4 and the nines-complement of 0 is 9. An example of an encoding procedure for the Social Security Number, 123-45-6789 is as follows:
Procedure |
Before/After |
Nines-complement of digits 2,4,8,9 |
123-45-6789 / 173-55-6710 |
Rotate left - digits 1,3,5,6 |
173-55-6710 / 375-56-1710 |
Rotate right - digits 2,3,8,9 |
375-56-1710 / 307-66-1751 |
EXAMPLE: Client identifier is 001000002357901: 001000002357901
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 1.3: Record identifier
PURPOSE: To identify one record among many for a client.
LENGTH: 6
FIELD LOCATION: 19-24
TYPE: Numeric – right justify
SKIP PATTERN: This field should always be completed.
CONTENTS: A six-digit numeric code. This field will be used to identify one unique record among many for a client. For example, the record identifier can be a visit date or a sequential record number.
EXPLANATION: A screening cycle begins with
either an initial colorectal cancer test or the distribution of a
fecal kit, continues through any additional tests required for
diagnostic evaluation following an abnormal or incomplete test, and
ends when a final diagnosis is reached and treatment is initiated,
when required.
Each CCDE record identifies a unique
screening cycle for a client. A client can have multiple screening
cycles reported in the CCDE file. The record identifier helps to
differentiate one screening cycle among many for a client. The
record identifier could be the date of cycle initiation (e.g. FOBT
date), or it could simply be a sequential number (e.g. 1 = first
cycle, 2 = second cycle, etc).
Grantees are asked to be
consistent in the method used for creating a record identifier.
EXAMPLE: Using a date of 4/1/2010: 040110
Using a cycle number of 1: 000001 or 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 2.1: Date of birth
PURPOSE: To specify the date of birth self-reported by a client.
LENGTH: 8
FIELD LOCATION: 25-32
TYPE: Date
SKIP PATTERN: This field should always be completed.
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is the month of birth from 01 to 12, DD is the day of birth from 01 to 31, and YYYY is the year of birth, including the century. If just the year is known, then blank fill the month and day. If just the year and month are known, then blank fill the day (e.g. 01 1955). At a minimum, the year of birth must be reported.
EXPLANATION: Date of birth must be self-reported by the client. This field is used to compute age values and is vital to various analyses. It is, therefore, important to provide as complete a date as possible.
EXAMPLE: For a client born on May 1, 1953: 05011953
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 2.2: Gender
PURPOSE: To specify the gender self-reported reported by a client.
LENGTH: 1
FIELD LOCATION: 33
TYPE: Numeric
SKIP PATTERN: This field should always be completed.
CONTENTS: 1 = Male
2 = Female
9 = Other/unknown
EXPLANATION: Gender must be self-reported by the client. A response of 9 (Other/unknown) in the context of this question could mean that the client was not asked, the client’s answer was not recorded, the client self-identified with a gender other than male or female, or the client refused to answer the question.
EXAMPLE: Client is female: 2
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 2.3 Hispanic or Latino origin
PURPOSE: To indicate the self-reported Hispanic or Latino Origin of a client.
LENGTH: 1
FIELD LOCATION: 34
TYPE: Numeric
SKIP PATTERN: This field should always be completed.
CONTENTS: 1 = Yes
2 = No
9 = Unknown/missing
EXPLANATION: The method of identifying Hispanic or Latino Origin must be self-identification by the client. Consider placing this field prior to race on the data form for better completion of the race/ethnicity data.
Hispanic Origin or Latino should be collected as a separate data field from race. If Hispanic or Latino Origin is not collected separately from race on your forms and a client reports race as Hispanic, then Item 2.3 (Hispanic or Latino origin) should be reported as 1 (Yes) and Item 2.4.1 (Race 1) should be reported as 9 (Unknown). If Hispanic or Latino Origin is not collected separately and a client reports race as something other than “Hispanic” or “Latino”, then Item 2.3 (Hispanic or Latino Origin) should be reported as 9 (Unknown/missing). If Hispanic or Latino Origin is not asked of the client, the answer is not recorded, the client doesn’t know or the client refuses to answer, then report 9 (Unknown/missing).
EXAMPLE: For a self-reported Hispanic or Latino client: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 2.4.1: Race 1
PURPOSE: To indicate the first race that is self-reported by a client.
LENGTH: 1
FIELD LOCATION: 35
TYPE: Numeric
SKIP PATTERN: This field should always be completed.
CONTENTS: 1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
9 = Unknown
EXPLANATION: The method of identifying race must be self-identification by the client. If a client reports more than one race category, then this field should be populated first; and Item 2.4.2 “Race 2” through Item 2.4.5 “Race 5” should be used sequentially, as needed, to report additional race categories. No primary race is collected. The Race 1 field has no significance over Race 2-5, and may simply be the first race that is mentioned or recorded by the client.
If Item 2.3 (Hispanic or Latino origin) is
not collected separately from race, and race is reported as
“Hispanic”, then race should be reported to the CDC as 9
(Unknown) and Item 2.3 (Hispanic or Latino Origin) should be reported
to the CDC as 1 (Yes).
The response options for this item
are defined by the Office of Management and Budget (OMB) for the
collection of race and ethnicity data. Additional information is
available on the OMB Web site at
http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this chapter (Chapter 2) in Appendix B. The code set offers a detailed list of race concepts that can be used for data collection, and guidance for collapsing those detailed concepts into the standard form used in the CCDEs.
EXAMPLE: If a client self-identifies as Asian: 3
REVISION HISTORY:
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ITEM NO / NAME: 2.4.2: Race 2
PURPOSE: To indicate the second race that is self-reported by a client.
LENGTH: 1
FIELD LOCATION: 36
TYPE: Numeric
SKIP PATTERN: This field should be completed when more than one race is self-reported by a client; otherwise, leave blank.
CONTENTS: 1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
EXPLANATION: The method of identifying race must be self-identification by the client. This field should be left blank unless a client reports more than one race. No primary race is collected. The Race 1 field has no significance over Race 2, and Race 2 has no significance over the Race 3-5 fields. It may simply be the second race mentioned by a client. Unknown race must be reported in the Race 1 field.
The response options for this item
are defined by the Office of Management and Budget (OMB) for the
collection of race and ethnicity data. Additional information is
available on the OMB Web site at
http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this chapter in Appendix B. The code set offers a detailed list of race concepts that can be used for data collection, and guidance for collapsing those detailed concepts into the standard form used in the CCDEs.
EXAMPLE: If a client identifies as Asian and White: Race 1 = 3 and Race 2 = 1
REVISION HISTORY:
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ITEM NO / NAME: 2.4.3: Race 3
PURPOSE: To indicate the third race that is self-reported by a client.
LENGTH: 1
FIELD LOCATION: 37
TYPE: Numeric
SKIP PATTERN: This field should be completed when more than two races are self-reported by a client; otherwise, leave blank.
CONTENTS: 1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
EXPLANATION: The method of identifying race must be self-identification by the client. This field should be left blank unless a client reports more than two races. No primary race is collected. The Race 1-2 fields have no significance over the Race 3-5 fields. It may simply be the third race mentioned by a client. Unknown race must be reported in the Race 1 field.
The response options for this item
are defined by the Office of Management and Budget (OMB) for the
collection of race and ethnicity data. Additional information is
available on the OMB Web site at
http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this chapter in Appendix B. The code set offers a detailed list of race concepts that can be used for data collection, and guidance for collapsing those detailed concepts into the standard form used in the CCDEs.
EXAMPLE: If a client identifies as Asian, White and African American: Race 1 = 3; Race 2 = 1; and Race 3 = 2
REVISION HISTORY:
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ITEM NO / NAME: 2.4.4: Race 4
PURPOSE: To indicate the fourth race that is self-reported by a client.
LENGTH: 1
FIELD LOCATION: 38
TYPE: Numeric
SKIP PATTERN: This field should be completed when more than three races are self-reported by a client; otherwise, leave blank.
CONTENTS: 1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
EXPLANATION: The method of identifying race must be self-identification by the client. This field should be left blank unless a client reports more than three races. No primary race is collected. The Race 1-3 fields have no significance over the Race 4-5 fields. It may simply be the fourth race mentioned by a client. Unknown race must be reported in the Race 1 field.
The response options for this item
are defined by the Office of Management and Budget (OMB) for the
collection of race and ethnicity data. Additional information is
available on the OMB Web site at
http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this chapter in Appendix B. The code set offers a detailed list of race concepts that can be used for data collection, and guidance for collapsing those detailed concepts into the standard form used in the CCDEs.
EXAMPLE: If a client identifies as Asian, White, African American and Alaska Native: Race 1 = 3; Race 2 = 1; Race 3 = 2; and Race 4 = 5
REVISION HISTORY:
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ITEM NO / NAME: 2.4.5: Race 5
PURPOSE: To indicate the fifth race that is self-reported by a client.
LENGTH: 1
FIELD LOCATION: 39
TYPE: Numeric
SKIP PATTERN: This field should be completed when more than four races are self-reported by a client; otherwise, leave blank.
CONTENTS: 1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
EXPLANATION: The method of identifying race must be self-identification by the client. This field should be left blank unless a client reports more than four races. No primary race is collected. The Race 1-4 fields have no significance over the Race 5 field. It may simply be the fifth race mentioned by a client. No more than five races will be reported for a client in any CCDE record. Unknown race must be reported in the Race 1 field.
The response options for this item
are defined by the Office of Management and Budget (OMB) for the
collection of race and ethnicity data. Additional information is
available on the OMB Web site at
http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this chapter in Appendix B. The code set offers a detailed list of race concepts that can be used for data collection, and guidance for collapsing those detailed concepts into the standard form used in the CCDEs.
EXAMPLE: If a client identifies as Asian, White, African American, Alaskan Native and Hawaiian: Race 1 = 3; Race 2 = 1; Race 3 = 2; Race 4 = 5; and Race 5 = 4
REVISION HISTORY:
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ITEM NO / NAME: 2.5: State of residence
PURPOSE: To indicate the FIPS code for a client’s state of residence.
LENGTH: 2
FIELD LOCATION: 40-41
TYPE: Numeric - right justify
SKIP PATTERN: If known, this field should be completed; otherwise, leave blank.
CONTENTS: A 2-digit numeric code.
EXPLANATION: State of residence must be self-reported by the client. The state Federal Information Processing Standard (FIPS) codes are developed by the National Institute of Standards and Technology (NIST) and are available at
http://www.itl.nist.gov/fipspubs/fip5-2.htm. There is a code for each state and territory.
EXAMPLE: Client’s state of residence is Maryland: 24
REVISION HISTORY:
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ITEM NO / NAME: 2.6 County of residence
PURPOSE: To indicate the FIPS code for a client’s county of residence.
LENGTH: 3
FIELD LOCATION: 42-44
TYPE: Numeric - right justify
SKIP PATTERN: If known, this field should be completed; otherwise, leave blank.
CONTENTS: A 3-digit numeric code relevant to the State of residence reported in Item 2.5.
EXPLANATION: County of residence must be self-reported by the client. The county FIPS codes are the Federal Information Processing Standard codes developed by the National Institute of Standards and Technology (NIST) and are available at http://www.itl.nist.gov/fipspubs/co-codes/states.htm. There is a 3-digit code for each county in a state or territory. If the state or territory where the client lives does not have counties, enter 999.
EXAMPLE: Client’s county of residence is Frontier, Nebraska: 063
REVISION HISTORY:
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ITEM NO / NAME: 3.1: Has client ever had a colorectal screening test?
PURPOSE: To indicate if a client has previously received any of the following colorectal screening tests: take-home FOBT, take-home FIT, sigmoidoscopy, colonoscopy, DCBE, CTC (virtual colonoscopy) or stool DNA.
LENGTH: 1
FIELD LOCATION: 45
TYPE: Numeric
SKIP PATTERN: This field should always be completed.
CONTENTS: 1 = Yes
2 = No
9 = Unknown
EXPLANATION: This information can be
self-reported by the client, or can come from information documented
in the client’s medical record. Medical record information is
preferred, if available. Fecal tests done by a provider in an office
are not acceptable and should not be recorded in this field.
If
the client has had any of the above noted colorectal screening tests
in the past, then complete this field as 1 (Yes). If the client has
never had a colorectal screening test prior to the visit, then
complete this field as 2 (No). If the client has had a previous
colorectal screening test within the program (as part of a separate
screening cycle), complete this field as 1 (Yes).
A response of 9 (Unknown) in the context of this question may mean that the client was not asked, the answer was not recorded, the client was unsure, or the client refused to answer the question.
EXAMPLE: If a client has previously had a take-home FOBT or FIT: 1
REVISION HISTORY:
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ITEM NO / NAME: 4.1: Personal history of CRC (colorectal cancer) or precancerous polyps
PURPOSE: To indicate if a client has ever been diagnosed with colorectal cancer or adenomatous/pre-cancerous polyps.
LENGTH: 1
FIELD LOCATION: 46
TYPE: Numeric
SKIP PATTERN: This field should always be completed.
If Item 4.1 (Personal history of CRC (colorectal cancer) or precancerous polyps) = 1 (Yes), then Item 6.0 (Indication for test 1) should not = 1 (Screening).
CONTENTS: 1 = Yes
2 = No
9 = Unknown
EXPLANATION: This
field is used to indicate if a client has ever been diagnosed with
colorectal cancer, which is cancer of the colon or rectum. Other
possible terms for CRC include colon cancer, rectal cancer, cancer of
the large intestine, cancer of the large bowel, and bowel cancer.
Anal cancer, or cancer of the anus, should not be reported in this
field.
It should also be used to indicate if the client
has ever been diagnosed with a precancerous polyp or pre-malignant
polyp. A precancerous/pre-malignant polyp would include any
adenomatous polyps. A response of 1 (Yes) will indicate that the
client is at increased risk for CRC, and Item 6.0 (Indication for
test 1) cannot be reported as 1 (Screening).
This information can be self-reported by the client, or can come from information documented in the client’s medical record. Medical record information is preferred, if available. If the client indicates that he/she has been previously diagnosed with CRC or had a precancerous polyp, then this field should be completed as 1 (Yes). If the client has never been diagnosed with CRC or a pre-cancerous polyp prior to the visit, then complete this field as 2 (No).
A response of 9 (Unknown) in the context of this question may mean that the client was not asked, the answer was not recorded, the client was unsure, or the client refused to answer the question.
EXAMPLE: A client indicates he/she was diagnosed with CRC previously: 1
REVISION HISTORY:
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ITEM NO / NAME: 4.2: Family history of CRC
PURPOSE: To indicate if the client has a family history of colorectal cancer.
LENGTH: 1
FIELD LOCATION: 47
TYPE: Numeric
SKIP PATTERN: This field should always be completed.
CONTENTS: 1 = Yes
2 = No
9 = Unknown
EXPLANATION: This information should be self-reported by the client, or can come from information documented in the client’s medical record. Medical record information is preferred, if available.
The information reported in this field may
include family history of either CRC or adenomatous polyps.
Each grantee, in conjunction with the Medical Advisory Board, will determine criteria and type of screening test offered for clients at increased risk for CRC due to family history of CRC or adenomatous polyps. These criteria should be consistent with available guidelines.
EXAMPLE: A client’s father was diagnosed with CRC: 1
REVISION HISTORY:
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ITEM NO / NAME: 4.3: Currently experiencing CRC symptoms
PURPOSE: To indicate if the client is currently experiencing colorectal cancer symptoms.
LENGTH: 1
FIELD LOCATION: 48
TYPE: Numeric
SKIP PATTERN: This field should always be completed.
CONTENTS: 1 = Yes
2 = No
9 = Unknown
EXPLANATION: This information can be
self-reported by the client, or can come from information documented
in the client’s medical record. Medical record information is
preferred, if available.
Each grantee should work with
its Medical Advisory Board to define a list of symptoms requiring
medical evaluation. The list may include, but may not be limited
to:
Rectal bleeding, bloody diarrhea, or blood in the stool within the past 6 months (bleeding that is known or suspected to be due to hemorrhoids after clinical evaluation would not prevent a client from receiving CRC screening services).
Prolonged change in bowel habits (e.g., diarrhea or constipation for more than two weeks that has not been clinically evaluated).
Persistent abdominal pain.
Symptoms of bowel obstruction (e.g., abdominal distension, nausea, vomiting, severe constipation).
Significant unintentional weight loss of 10% or more of starting body weight.
If the response is 1 (Yes), then the client is clinically ineligible for CRCCP funded testing, and will need to be referred out of the program for the appropriate medical care or evaluation.
If a clinically ineligible client is subsequently evaluated and cleared for screening, they may be enrolled for CRCCP funded testing with Item 4.3 updated from 1 (Yes) to 2 (No).
EXAMPLE: The client is not currently experiencing any CRC symptoms: 2
REVISION HISTORY:
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ITEM NO / NAME: 5.1: Initial test appointment date, or date fecal kit distributed
PURPOSE: To indicate the date testing was initiated for a client based on date of FOBT/FIT kit distribution or the initial appointment date for the first test recommended within this cycle.
LENGTH: 8
FIELD LOCATION: 49 - 56
TYPE: Date
SKIP PATTERN: This field should always be completed.
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is a value from 01 to 12, DD is a value from 01 to 31, and YYYY is the year, including the century. No part of this date field may be left blank.
If a month or day is unknown, then that part of the date should be completed using a valid default value. Each grantee should decide upon the default values to be used for unknown month and/or day, and should apply them consistently. For example, your Program may choose to use “06” for unknown month and “15” for unknown day. Do not use “99” to report unknown month or day values.
EXPLANATION: If the initial test was a take-home FOBT or take-home FIT, then indicate the date that the fecal kit was distributed to the client. Otherwise, indicate the initial appointment date scheduled for the first test.
EXAMPLE: If an FOBT kit was mailed to the client on 3/5/2010: 03052010
REVISION HISTORY:
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ITEM NO / NAME: 5.2: Screening adherence
PURPOSE: To indicate if the client received the initial test recommended.
LENGTH: 1
FIELD LOCATION: 57
TYPE: Numeric
SKIP PATTERN: This
field should always be completed.
If Item 5.2 (Screening
adherence) = 1 (Test Performed), then Section 6 must be completed to
report at least one test performed.
If Item 5.2 (Screening
adherence) is not = 1 (Test Performed), then Sections 6 through 11
should be left blank. Section 12 must be completed for each record.
CONTENTS: 1 = Test Performed
2 = Test Pending
3 = No test performed, FOBT/FIT card not returned
4 = No test performed, appointment not kept
EXPLANATION: Each
grantee will need to establish guidelines to determine when a fecal
kit is considered unreturned, how much time can elapse or the number
of appointments rescheduled before a client is considered an
appointment no show.
If the client returns the fecal kit,
or receives the initial test within the timeline established by the
grantee, indicate 1 (Test performed).
If at the time of
CCDE data submission, the client has not returned the fecal kit or
received an initial test, but the timeframe established has not
expired, indicate 2 (Test pending).
If the established
timeframe has been reached, and the fecal kit has not been returned,
indicate 3 (No test performed, FOBT/FIT card not returned). The CCDE
cycle should be considered closed. In the event that an alternative
test, such as a colonoscopy, is provided to the client, the
colonoscopy should be recorded in a new CCDE cycle as the initial
test.
If, once the established timeframe has been
reached, and the appointment for the initial test has not been kept,
indicate 4 (No test performed, appointment not kept). The CCDE cycle
should be considered closed. This does not mean that attempts to get
the client in for testing should stop. If the client does return for
an initial test, a new CCDE cycle should be created.
EXAMPLE: If the client returns their FOBT kit: 1
REVISION HISTORY:
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ITEM NO / NAME: 6.0: Indication for test 1
PURPOSE: To report the indication or purpose for the first test provided to the client, reported in Item 6.1.01 (Test 1 performed).
LENGTH: 1
FIELD LOCATION: 58
TYPE: Numeric
SKIP PATTERN: This field should be completed when 5.2 (Screening Adherence = 1 (Test Performed).
If Item 4.1 (Personal history of CRC (colorectal cancer) or precancerous polyps) = 1 (Yes), then Item 6.0 (Indication for test 1) should not = 1 (Screening).
CONTENTS: 1 =
Screening
2 = Surveillance
3 = Diagnostic
9 =
Unknown
EXPLANATION: A
screening test (1) is a test provided for a client who has no
colorectal cancer symptoms, may have never been screened for
colorectal cancer, or may have had a previous screening test without
significant findings and is due for routine rescreening.
A
surveillance test (2) is a test (typically a colonoscopy) done at
more frequent intervals than screening to evaluate a client who has
a known history of colorectal polyps or colorectal cancer, to look
for recurrence of these. The appropriate intervals for surveillance
tests can be found in published guidelines.
A diagnostic
test (3) is a test (typically a DCBE or colonoscopy) performed to
evaluate signs or symptoms or to follow-up an abnormal screening
test. An indication of 3 (Diagnostic) should occur infrequently,
and should be monitored by grantees.
If the first test to be provided is a take-home fecal kit (FOBT or FIT), then the Indication for test 1 should not = 3 (Diagnostic). If the first test to be provided is a DCBE, then the Indication for test 1 should not = 1 (Screening).
EXAMPLE: If the purpose of the first test provided is for screening: 1
REVISION HISTORY:
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ITEM NO / NAME: 6.1.01: Test 1 performed
PURPOSE: To indicate the first test received by the client within the current cycle.
LENGTH: 1
FIELD LOCATION: 59
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 5.2 (Screening Adherence) = 1 (Test Performed).
If Item 6.0 (Indication for test 1) = 1 (Screening), then Item 6.1.01 should not = 5 (DCBE).
If Item 6.0 (Indication for test 1) = 3 (Diagnostic), then Item 6.1.01 should only = 4 or 5.
CONTENTS: 1 =
Take-home Fecal Occult Blood Test (FOBT)
2 = Take-home Fecal
Immunochemical Test (FIT)
3 = Sigmoidoscopy
4 =
Colonoscopy
5 = Double-contrast Barium Enema (DCBE)
7 =
Other
EXPLANATION: This field should be reported with the first test received by the client within the current cycle.
EXAMPLE: If the first test provided to the client is a sigmoidoscopy: 3
REVISION HISTORY:
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ITEM NO / NAME: 6.1.02: Test 1 performed – Other specify
PURPOSE: To specify the type of “other” test indicated in Item 6.1.01 (Test 1 performed).
LENGTH: 40
FIELD LOCATION: 60 - 99
TYPE: Free text
SKIP PATTERN: This field should be completed when Item 6.1.01 (Test 1 performed) = 7 (Other); otherwise, leave blank.
EXPLANATION: This field captures the type of “other” test indicated in Item 6.1.01. Use this item appropriately. Reclaiming inappropriate “other” responses is time consuming and could potentially result in the loss of valuable data.
EXAMPLE: If a virtual colonoscopy is performed: virtual colonoscopy
REVISION HISTORY:
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ITEM NO / NAME: 6.1.03: Date of test 1
PURPOSE: To specify the date of the first test.
LENGTH: 8
FIELD LOCATION: 100 - 107
TYPE: Date
SKIP PATTERN: This field should be completed when Item 5.2 (Screening Adherence) = 1 (Test Performed).
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is the month from 01 to 12, DD is the day from 01 to 31, and YYYY is the year of the test, including the century. If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 08 2010). This field should not be left completely blank if a first test was performed.
EXPLANATION: This
field captures the date that test 1 is performed. If the test is a
take-home FOBT or FIT, then report the date that the kit was
processed.
If a test was recommended, but the appointment
was not kept, or the FOBT/FIT kit was not returned, then this
information should be reported in Item 5.1 (Initial test appointment
date, or date fecal kit distributed) and Item 5.2 (Screening
adherence). Items in Section 6 (Screening and Diagnostic Tests
Performed) are limited to reporting data on tests that were
completed.
EXAMPLE: If a colonoscopy is performed on August 1, 2010: 08012010
REVISION HISTORY:
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ITEM NO / NAME: 6.1.04: Provider specialty
PURPOSE: To report the specialty of the clinician providing the first test.
LENGTH: 2
FIELD LOCATION: 108 - 109
TYPE: Numeric - right justify
SKIP PATTERN: This field should be completed when Item 5.2 (Screening Adherence) = 1 (Test Performed).
CONTENTS: 1 =
General practitioner
2 = Internist
3 = Family
practitioner
4 = Gastroenterologist
5 = General
surgeon
6 = Colorectal surgeon
7 = Licensed practical
nurse
8 = Registered nurse
9 = Nurse practitioner
10
= Physician assistant
11 = Administrator, if FOBT/FIT mailed by
non-clinician
12 = Radiologist
13 =
Obstetrician/Gynecologist (OB/GYN)
99 = Unknown
EXPLANATION: This field should capture the medical practice specialty of the provider who performed or provided the first test reported in Item 6.1.01.
If the first test is an FOBT/FIT, capture the specialty of the individual that made the assessment that a FOBT/FIT should be provided to the client.
A response of 11 (Administrator, if FOBT/FIT mailed by non-clinician) should be used only when an administrator, not a clinician, makes the assessment that a FOBT/FIT kit should be provided to the client.
EXAMPLE: If the provider specialty for the first test is a general surgeon: 5
REVISION HISTORY:
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ITEM NO / NAME: 6.1.05: Result of test 1
PURPOSE: To specify the result of test 1.
LENGTH: 1
FIELD LOCATION: 110
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 5.2 (Screening Adherence) = 1 (Test Performed).
If Item 6.1.01
(Test 1 performed) = 1 (Take-home FOBT) or 2 (Take-home FIT), then
Item 6.1.05 must = 5, 6, 7 or 9.
If Item 6.1.01 (Test 1
performed) = 3 (Sigmoidoscopy), 4 (Colonoscopy) or 5 (DCBE), then
Item 6.1.05 must = 1- 4, 7 or 9.
If Item 6.1.01 (Test 1
performed) = 7 (Other), then Item 6.1.05 must be reported using the
result that is appropriate for the test performed and specified in
Item 6.1.02 (Test 1 performed – other specify).
CONTENTS: 1 =
Normal/Negative/Diverticulosis/Hemorrhoids
2 = Other finding
not suggestive of cancer or polyp(s)
3 = Polyp(s), or
Lesion(s) suspicious for cancer
4 = Inadequate/Incomplete test
with no findings
5 = FOBT/FIT/Other Test Performed Negative
6
= FOBT/FIT/Other Test Performed Positive
7 = Pending
9 =
Unknown
EXPLANATION: If more
than one result is noted on the medical chart, then report the most
severe.
For take-home FOBT, take-home FIT or other
similar stool tests, if the medical chart records any gradation of
positive (e.g. “weakly positive” or “slightly
positive”), then Item 6.1.05 should be recorded as 6
(FOBT/FIT/Other Test Performed Positive).
A response of 2
(Other finding not suggestive of cancer or polyp(s) should be used
when the endoscopy report indicates a specific finding, but the
finding is not a cancerous lesion or a polyp. Examples of Other
findings may include:
Colitis (inflammation of the bowel wall)
Arteriovenous malformation
Ulcerative colitis
Crohn’s colitis
A result of 4 (Inadequate/Incomplete) should only be reported when the endoscopy report notes that an exam was started but was incomplete or inadequate, and does not report any specific findings. Incomplete or inadequate tests may occur due to client discomfort or distress, bowel obstruction, inadequate bowel preparation (the bowel was not adequately cleared of fecal material) or physician fatigue.
If the endoscopy report notes specific findings, even during an incomplete or inadequate test, then the test result should reflect the observations and be reported using response options 1, 2 or 3.
When a Test Result = 4 (Inadequate/Incomplete), then Item 6.1.09 (Test Outcome) should be coded as 2 (Incomplete/Inadequate) and an additional test should be recommended.
EXAMPLE: If result of the take-home FOBT is positive: 6
REVISION HISTORY:
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ITEM NO / NAME: 6.1.06: Was a biopsy/polypectomy performed during the endoscopy?
PURPOSE: To indicate if a biopsy or polypectomy was performed during the sigmoidoscopy or colonoscopy.
LENGTH: 1
FIELD LOCATION: 111
TYPE: Numeric
SKIP PATTERN: If Item 6.1.06 = 1 (Yes), then Item 7.1 (Histology of most severe polyp/lesion) must be completed.
Leave blank if Item 6.1.01 (Test 1 performed) = 1 (Take-home FOBT), 2 (Take-home FIT), 5 (DCBE) or 7 (Other).
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: This
field should only be completed if the first test provided is either
a colonoscopy or sigmoidoscopy.
If a biopsy was
performed (1), then Item 7.1 (Histology of most severe polyp/lesion)
must be completed.
EXAMPLE: If a polypectomy was performed during a colonoscopy: 1
REVISION HISTORY:
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12/02/2009 |
Add new |
ITEM NO / NAME: 6.1.07: Was the bowel preparation considered adequate by the clinician performing the endoscopy or DCBE?
PURPOSE: To indicate the adequacy of the bowel preparation for a sigmoidoscopy, colonoscopy or DCBE.
LENGTH: 1
FIELD LOCATION: 112
TYPE: Numeric
SKIP PATTERN: This field should be completed if Item 6.1.01 (Test 1 performed) = 3 (Sigmoidoscopy), 4 (Colonoscopy), 5 (DCBE) or 7 (Other); otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: Adequacy
of the bowel preparation will be determined by the clinician
performing the test. A response of 1 (Yes) or 2 (No) can only be
reported if the procedure report explicitly states that the bowel
preparation was adequate or inadequate; otherwise report 9
(Unknown).
If Test 1 = 7 (Other) and the procedure does
not require bowel preparation, please code the adequacy of bowel
preparation as 9 (Unknown).
If the adequacy of bowel
preparation = 2 (No), then Item 6.1.09 (Test outcome) should be
coded as 2 (Incomplete/Inadequate).
The standardized colonoscopy reporting and data system (CO-RADs) quality measure for adequacy of bowel prep is described as adequacy to detect polyps > 5 mm.
EXAMPLE: If procedure report indicates adequate bowel preparation: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.1.08: Was the cecum reached during the colonoscopy?
PURPOSE: To indicate whether or not the procedure report notes that the cecum was reached during the colonoscopy.
LENGTH: 1
FIELD LOCATION: 113
TYPE: Numeric
SKIP PATTERN: This field should be completed if Item 6.1.01 (Test 1 performed) = 4 (Colonoscopy); otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: The
procedure report must explicitly state that the cecum was reached or
not reached during the colonoscopy in order to report 1 (Yes) or 2
(No); otherwise, report 9 (Unknown).
If the 6.1.08 = 2
(No), then 6.1.09 (Outcome) should be coded as 2
(Incomplete/Inadequate).
EXAMPLE: If cecum was not reached: 2
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.01 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.1.09: Test 1 outcome
PURPOSE: To indicate if the test reported in Item 6.1.01 was complete.
LENGTH: 1
FIELD LOCATION: 114
TYPE: Numeric
SKIP PATTERN: If
Item 6.1.05 (Result of test 1) = 5 (FOBT/FIT/Other Test Performed
Negative) or 6 (FOBT/FIT/Other Test Performed Positive), then Item
6.1.09 should = 1 (Complete).
If Item 6.1.05 (Result of
test 1) = 4 (Inadequate/Incomplete test with no findings), then Item
6.1.09 should = 2 (Incomplete/Inadequate).
If Item 6.1.07
(Bowel Prep Adequacy) = 2 (No), then Item 6.1.09 should = 2
(Incomplete/Inadequate).
If Item 6.1.08 (Cecum reached) =
2 (No), then Item 6.1.09 should = 2 (Incomplete/Inadequate).
CONTENTS: 1 =
Complete
2 = Incomplete/Inadequate
EXPLANATION: Each
test provided should have a specific result that is reported in Item
6.1.05 (Result of test 1). If the test was completed
satisfactorily, report 1 (Complete).
If there were
circumstances that prevented the test from being performed
satisfactorily such as an obstruction, inadequate bowel prep, or the
cecum was not reached during colonoscopy, then report 2
(Incomplete/Inadequate).
If there are multiple polyps,
and some of those polyps are extremely small (< 5mm), it is
acceptable for the provider to choose not to remove the smaller
polyps. In these instances, the Test Outcome would be considered 1
(Complete). If the recommendation of a repeat colonoscopy in 3-6
months is made, then that procedure would begin a new cycle where
the indication (Item 6.0) would be reported as 2 (Surveillance).
If the provider recommends an immediate repeat exam (or
additional tests needed to come to a Final Diagnosis) due to the
incomplete, or non-removal of a significant polyp, then report 2
(Incomplete/Inadequate). Report the repeat exam (or additional
tests needed) as Test 2.
EXAMPLE: If the colonoscopy is considered complete: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.1.10: Recommended next follow-up procedure within this cycle.
PURPOSE: To indicate the next recommended procedure following the completion of Test 1 needed to complete this cycle. (This should not be confused with Item 9.04 to report the next test recommended for re-screening or surveillance.)
LENGTH: 1
FIELD LOCATION: 115
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 5.2 (Screening Adherence = 1 (Test Performed).
CONTENTS: 1 =
Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to
complete diagnosis
7 = Other
8 = None (cycle is complete)
EXPLANATION: Once test 1 is completed, the next recommended procedure within the screening cycle should be reported. The next recommended test within the screening cycle should either be a diagnostic test to follow-up a positive initial screening test or another screening test where the first screening test was incomplete or inconclusive.
If the next
recommended follow-up procedure within the cycle is 4 (surgery to
completed diagnosis) or 8 (none), then Items (6.2.01, 6.3.01 or
6.4.01, Tests2-4 performed) should be coded with 0 (None).
In the rare event that surgery is needed to complete diagnosis, Items 8.1 and 8.2 should then be completed, along with any final diagnosis and treatment data where applicable.
There may be rare instances in which it is appropriate for an FOBT or FIT to be recommended as a follow-up procedure within the cycle and reported as Test 2. In these instances Item 6.1.10 should be reported as 7 (Other). Item 6.1.11 (Other recommended test, specify) should be completed to indicate FOBT or FIT as the recommended next test within the cycle. These instances may include:
The initial FOBT or FIT card could not be read by the lab
Client did not perform the initial FOBT or FIT correctly
An FOBT or FIT is recommended as follow-up to an incomplete or inconclusive colonoscopy that cannot be repeated
EXAMPLE: If a DCBE is recommended as the next procedure within this client’s “cycle”: 3
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.1.11: Other recommended test, specify
PURPOSE: To specify the Other test recommended in Item 6.1.10.
LENGTH: 40
FIELD LOCATION: 116 - 155
TYPE: Free text.
SKIP PATTERN: This field should be completed when Item 6.1.10 (Recommended next follow-up procedure within this cycle) is reported as 7 (Other); otherwise, leave blank.
EXPLANATION: This field captures the type of “other” test indicated in Item 6.1.10. Use this item appropriately. Reclaiming inappropriate “other” responses is time consuming and could potentially result in the loss of valuable data.
EXAMPLE: If the next recommended test is a virtual colonoscopy: virtual colonoscopy
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.01: Test 2 performed
PURPOSE: To indicate the second test received by the client within the current cycle.
LENGTH: 1
FIELD LOCATION: 156
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 5.2 (Screening Adherence) = 1 (Test Performed).
CONTENTS: 0 = None
3
= Sigmoidoscopy
4 = Colonoscopy
5 = Double-contrast Barium
Enema (DCBE)
7 = Other
EXPLANATION: This field should be reported with the second test received by the client within the current cycle.
EXAMPLE: If the second test provided to the client is a DCBE: 5
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.02: Test 2 performed – Other specify
PURPOSE: To specify the type of “other” test indicated in Item 6.2.01 (Test 2 performed).
LENGTH: 40
FIELD LOCATION: 157 - 196
TYPE: Free text
SKIP PATTERN: This field should be completed when Item 6.2.01 (Test 2 performed) = 7 (Other); otherwise, leave blank.
EXPLANATION: This field captures the type of “other” test indicated in Item 6.2.01. Use this item appropriately. Reclaiming inappropriate “other” responses is time consuming and could potentially result in the loss of valuable data.
EXAMPLE: If a virtual colonoscopy is performed: virtual colonoscopy
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.03: Date of Test 2
PURPOSE: To specify the date of the second test.
LENGTH: 8
FIELD LOCATION: 197 - 204
TYPE: Date
SKIP PATTERN: This field should be completed when Item 6.2.01 (Test 2 performed) is not = 0 (None).
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is month from 01 to 12, DD is the day from 01 to 31, and YYYY is the year of the test, including the century. If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 08 2010). This field should not be left completely blank if a second test was performed.
EXPLANATION: This
field captures the date that Test 2 is performed.
EXAMPLE: If
a colonoscopy is performed on August 1, 2010: 08012010
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.04: Provider specialty
PURPOSE: To report the specialty of the clinician providing the second test.
LENGTH: 2
FIELD LOCATION: 205 - 206
TYPE: Numeric - right justify
SKIP PATTERN: This field should be completed when Item 6.2.01 (Test 2 performed) is not = 0 (None).
CONTENTS: 1 =
General practitioner
2 = Internist
3 = Family
practitioner
4 = Gastroenterologist
5 = General
surgeon
6 = Colorectal surgeon
7 = Licensed practical
nurse
8 = Registered nurse
9 = Nurse practitioner
10
= Physician assistant
12 = Radiologist
13 =
Obstetrician/Gynecologist (OB/GYN)
99 = Unknown
EXPLANATION: This field should capture the medical practice specialty of the provider who performed or provided the first test reported in Item 6.2.01.
EXAMPLE: If the provider specialty for the second test is a general surgeon: 5
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.05: Result of Test 2
PURPOSE: To specify the results of Test 2.
LENGTH: 1
FIELD LOCATION: 207
TYPE: Numeric
SKIP PATTERN: This
field should be completed when Item 6.2.01 (Test 2 performed) is not
= 0 (None).
If Item 6.2.01 = 3 (Sigmoidoscopy), 4
(Colonoscopy) or 5 (DCBE), then Item 6.2.05 must = 1 - 4, 7 or
9.
If Item 6.2.01 = 7 (Other), then Item 6.2.05 must be
reported using the result that is appropriate for the test performed
and specified in Item 6.2.02
CONTENTS: 1 =
Normal/Negative/Diverticulosis/Hemorrhoids
2 = Other finding
not suggestive of cancer or polyp(s)
3 = Polyp(s), or
Lesion(s) suspicious for cancer
4 = Inadequate/Incomplete test
with no findings
5 = FOBT/FIT/Other Test Performed Negative
6
= FOBT/FIT/Other Test Performed Positive
7 = Pending
9 =
Unknown
EXPLANATION: If more
than one result is noted on the medical chart, then report the most
severe.
A response of 2 (Other finding not suggestive of
cancer or polyp(s) should be used when the endoscopy report
indicates a specific finding, but the finding is not a cancerous
lesion or a polyp.
A result of 4 (Inadequate/Incomplete)
should only be reported when the endoscopy report notes that an exam
was started but was incomplete or inadequate, and does not report
any specific findings. Incomplete or inadequate tests may occur due
to client discomfort or distress, bowel obstruction, inadequate
bowel preparation (the bowel was not adequately cleared of fecal
material) or physician fatigue.
If the endoscopy report notes specific findings, even during an incomplete or inadequate test, then the test result should reflect the observations and be reported using response options 1, 2 or 3.
When a Test Result = 4 (Inadequate/Incomplete), then Item 6.1.09 (Test Outcome) should be coded as 2 (Incomplete/Inadequate) and an additional test should be recommended.
EXAMPLE: If result of the colonoscopy is normal: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.06: Was a biopsy/polypectomy performed during the endoscopy?
PURPOSE: To indicate if a biopsy or polypectomy was performed during the sigmoidoscopy or colonoscopy.
LENGTH: 1
FIELD LOCATION: 208
TYPE: Numeric
SKIP PATTERN: If Item 6.2.06 = 1 (Yes), then Item 7.1 (Histology of most severe polyp/lesion) must be completed.
Leave blank if Item 6.2.01 = 0, 5 or 7.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: This
field should only be completed if the second test provided is either
a colonoscopy or sigmoidoscopy.
If a biopsy was
performed (1), then Item 7.1 (Histology of most severe polyp/lesion)
must be completed.
EXAMPLE: If a polypectomy was performed during a colonoscopy: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.07: Was the bowel preparation considered adequate by the clinician performing the endoscopy or DCBE?
PURPOSE: To indicate the adequacy of the bowel preparation for a sigmoidoscopy, colonoscopy or DCBE.
LENGTH: 1
FIELD LOCATION: 209
TYPE: Numeric
SKIP PATTERN: This field should be completed if Item 6.2.01 (Test 2 performed) = 3 (Sigmoidoscopy), 4 (Colonoscopy), 5 (DCBE) or 7 (Other); otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: Adequacy
of the bowel preparation will be determined by the clinician
performing the test. A response of 1 (Yes) or 2 (No) can only be
reported if the procedure report explicitly states that the bowel
preparation was adequate or inadequate; otherwise report 9
(Unknown).
If Test 2 = 7 (Other) and the procedure does
not require bowel preparation, please code the adequacy of bowel
preparation as 9 (Unknown).
If the adequacy of bowel
preparation = 2 (No), then Item 6.2.09 (Test outcome) should be
coded as 2 (Incomplete/Inadequate).
The standardized colonoscopy reporting and data system (CO-RADs) quality measure for adequacy of bowel prep is described as adequacy to detect polyps > 5 mm.
EXAMPLE: If procedure report indicates adequate bowel preparation: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.08: Was the cecum reached during the colonoscopy?
PURPOSE: To indicate whether or not the procedure notes report that the cecum was reached during the colonoscopy.
LENGTH: 1
FIELD LOCATION: 210
TYPE: Numeric
SKIP PATTERN: This field should be completed if Item 6.2.01 (Test 2 performed) = 4 (Colonoscopy); otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: The
procedure report must explicitly state that the cecum was reached or
not reached during the colonoscopy in order to report 1 (Yes) or 2
(No); otherwise, report 9 (Unknown).
If Item 6.2.08 is 2
(No), then Item 6.2.09 (Test 2 outcome) should be coded as 2
(Incomplete/Inadequate).
EXAMPLE: If cecum was not reached: 2
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.01 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.09: Test 2 outcome
PURPOSE: To indicate if the test reported in Item 6.2.01 was complete.
LENGTH: 1
FIELD LOCATION: 211
TYPE: Numeric
SKIP PATTERN: This
field should be completed when Item 6.2.01 (Test 2 performed) is not
0 = (None).
If Item 6.2.05 (Result of Test 2) = 4
(Inadequate/Incomplete test with no findings), then Item 6.2.09
should = 2 (Incomplete).
If Item 6.2.05 (Result of Test
2) = 5 (FOBT/FIT/Other Test Performed Negative) or 6 (FOBT/FIT/Other
Test Performed Positive), then Item 6.2.09 should = 1
(Complete).
If Item 6.2.07 (Bowel Prep Adequacy) = 2
(No), then Item 6.2.09 should = 2 (Incomplete).
If Item
6.2.08 (Cecum reached) = 2 (No), then Item 6.2.09 should = 2
(Incomplete).
CONTENTS: 1 =
Complete
2 = Incomplete/Inadequate
EXPLANATION: Each
test provided should have a specific result that is reported in Item
6.2.05. If the test was completed satisfactorily, report 1
(Complete).
If there were circumstances that prevented
the test from being performed satisfactorily such as an obstruction,
inadequate bowel prep, or the cecum was not reached, then report 2
(Incomplete/Inadequate).
If there are multiple polyps,
and some of those polyps are extremely small (< 5mm), it is
acceptable for the provider to choose not to remove the smaller
polyps. In these instances, the Test Outcome would be considered 1
(Complete). If the recommendation of a repeat colonoscopy in 3-6
months is made, then that procedure would begin a new cycle where
the indication (Item 6.0) would be reported as 2 (Surveillance).
If
the provider recommends an immediate repeat exam (or additional
tests needed to come to a Final Diagnosis) due to the incomplete, or
non-removal of a significant polyp, then report 2
(Incomplete/Inadequate). Report the repeat exam (or additional
tests needed) as Test 3.
EXAMPLE: If the colonoscopy is considered complete: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.10: Recommended next follow-up procedure within this cycle after test 2.
PURPOSE: To indicate the next recommended procedure following the completion of Test 2.
LENGTH: 1
FIELD LOCATION: 212
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 6.2.01 (Test 2 performed) is not = 0 (None).
CONTENTS: 1 =
Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to
complete diagnosis
7 = Other
8 = None (cycle is complete)
EXPLANATION: Once Test 2 is completed, the next recommended procedure within the screening cycle should be reported. The next recommended test within the screening cycle should either be a diagnostic test to follow-up a positive initial screening test or another screening test where the first and second screening tests were incomplete or inconclusive.
If the next
recommended procedure for the client is surgery to complete the
diagnosis, indicate 4 (Surgery). Items 8.1 and 8.2 should then be
completed, along with any final diagnosis and treatment data where
applicable. No further procedures (Items 6.3.01 or 6.4.01) should be
reported. Items 6.3.01 and 6.4.01 should be completed with 0
(None).
If Test 2 is normal
and the recommended screening or surveillance test for the next
cycle is FOBT or FIT, then indicate 8 (None). The screening cycle
should be considered complete and the next FOBT or FIT should begin
a new CCDE record. Items 6.3.01 and 6.4.01 should be completed with
0 (None).
There may be rare instances in which it is appropriate for an FOBT or FIT to be reported as Test 3. In these instances Item 6.2.10 should be reported as 7 (Other). Item 6.2.11 (Other recommended test, specify) should be completed to indicate FOBT or FIT as the recommended next test within the cycle. These instances may include:
FOBT or FIT card could not be read by the lab
Client did not perform FOBT or FIT correctly
An FOBT or FIT is recommended as follow-up to an incomplete or inconclusive colonoscopy that cannot be repeated
EXAMPLE: If a DCBE is recommended as the next procedure within this clients “cycle”: 3
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.2.11: Other recommended test, specify
PURPOSE: To specify the Other test recommended in Item 6.2.10.
LENGTH: 40
FIELD LOCATION: 213 - 252
TYPE: Free text.
SKIP PATTERN: This field should be completed when Item 6.2.10 is reported as 7 (Other); otherwise, leave blank.
EXPLANATION: This field captures the type of “other” test indicated in Item 6.2.10. Use this item appropriately. Reclaiming inappropriate “other” responses is time consuming and could potentially result in the loss of valuable data.
EXAMPLE: If the next recommended test is a virtual colonoscopy: virtual colonoscopy
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.01: Test 3 performed
PURPOSE: To indicate the third test received by the client within the current cycle.
LENGTH: 1
FIELD LOCATION: 253
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 5.2 (Screening Adherence) = 1 (Test Performed).
CONTENTS: 0 = None
3
= Sigmoidoscopy
4 = Colonoscopy
5 = Double-contrast Barium
Enema (DCBE)
7 = Other
EXPLANATION: This field should be reported with the third test received by the client within the current cycle.
EXAMPLE: If the third test provided to the client is a DCBE: 5
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.02: Test 3 performed – Other specify
PURPOSE: To specify the type of “other” test indicated in Item 6.3.01 (Test 3).
LENGTH: 40
FIELD LOCATION: 254 - 293
TYPE: Free text
SKIP PATTERN: This field should be completed when Item 6.3.01 (Test 3 performed) = 7 (Other); otherwise, leave blank.
EXPLANATION: This field captures the type of “other” test indicated in Item 6.3.01. Use this item appropriately. Reclaiming inappropriate “other” responses is time consuming and could potentially result in the loss of valuable data.
EXAMPLE: If a virtual colonoscopy is performed: virtual colonoscopy
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.03: Date of Test 3
PURPOSE: To specify the date of the third test.
LENGTH: 8
FIELD LOCATION: 294 - 301
TYPE: Date
SKIP PATTERN: This field should be completed when Item 6.3.01 (Test 3 performed) is not = 0 (None).
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is month from 01 to 12, DD is the day from 01 to 31, and YYYY is the year of the test, including the century. If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 08 2010). This field should not be left completely blank if a second test was performed.
EXPLANATION: This
field captures the date that Test 3 is performed.
EXAMPLE: If
a colonoscopy is performed on August 1, 2010: 08012010
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.04: Provider specialty
PURPOSE: To report the specialty of the clinician providing the third test.
LENGTH: 2
FIELD LOCATION: 302 - 303
TYPE: Numeric - right justify
SKIP PATTERN: This field should be completed when Item 6.3.01 (Test 3 performed) is not = 0 (None).
CONTENTS: 1 =
General practitioner
2 = Internist
3 = Family
practitioner
4 = Gastroenterologist
5 = General
surgeon
6 = Colorectal surgeon
7 = Licensed practical
nurse
8 = Registered nurse
9 = Nurse practitioner
10
= Physician assistant
12 = Radiologist
13 =
Obstetrician/Gynecologist (OB/GYN)
99 = Unknown
EXPLANATION: This field should capture the medical practice specialty of the provider who performed or provided the first test reported in Item 6.3.01.
EXAMPLE: If the provider specialty for the third test is a general surgeon: 5
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.05: Result of Test 3
PURPOSE: To specify the results of Test 3.
LENGTH: 1
FIELD LOCATION: 304
TYPE: Numeric
SKIP PATTERN: This
field should be completed when Item 6.3.01 (Test 3 performed) is not
= 0 (None).
If Item 6.3.01 = 3 (Sigmoidoscopy), 4
(Colonoscopy) or 5 (DCBE), then Item 6.3.05 must = 1 - 4, 7 or
9.
If Item 6.3.01 = 7 (Other), then Item 6.3.05 must be
reported using the result that is appropriate for the test performed
and specified in Item 6.3.02.
CONTENTS: 1 =
Normal/Negative/Diverticulosis/Hemorrhoids
2 = Other finding
not suggestive of cancer or polyp(s)
3 = Polyp(s), or
Lesion(s) suspicious for cancer
4 = Inadequate/Incomplete test
with no findings
5 = FOBT/FIT/Other Test Performed Negative
6
= FOBT/FIT/Other Test Performed Positive
7 = Pending
9 =
Unknown
EXPLANATION: If more
than one result is noted on the medical chart, then report the most
severe.
A response of 2 (Other finding not suggestive of
cancer or polyp(s) should be used when the endoscopy report
indicates a specific finding, but the finding is not a cancerous
lesion or a polyp.
A result of 4 (Inadequate/Incomplete)
should only be reported when the endoscopy report notes that an exam
was started but was incomplete or inadequate, and does not report
any specific findings. Incomplete or inadequate tests may occur due
to client discomfort or distress, bowel obstruction, inadequate
bowel preparation (the bowel was not adequately cleared of fecal
material) or physician fatigue.
If the endoscopy report notes specific findings, even during an incomplete or inadequate test, then the test result should reflect the observations and be reported using response options 1, 2 or 3.
When a Test Result = 4 (Inadequate/Incomplete), then Item 6.1.09 (Test Outcome) should be coded as 2 (Incomplete/Inadequate) and an additional test should be recommended.
EXAMPLE: If result of the colonoscopy is normal: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.06: Was a biopsy/polypectomy performed during the endoscopy?
PURPOSE: To indicate if a biopsy or polypectomy was performed during the sigmoidoscopy or colonoscopy.
LENGTH: 1
FIELD LOCATION: 305
TYPE: Numeric
SKIP PATTERN: If Item 6.3.06 = 1 (Yes), then Item 7.1 (Histology of most severe polyp/lesion) must be completed.
Leave blank if 6.3.01 = 0, 5 or 7.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: This
field should only be completed if the third test provided is either
a colonoscopy or sigmoidoscopy.
If a biopsy was
performed (1), then Item 7.1 (Histology of most severe polyp/lesion)
must be completed.
EXAMPLE: If a polypectomy was performed during a colonoscopy: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.07: Was the bowel preparation considered adequate by the clinician performing the endoscopy or DCBE?
PURPOSE: To indicate the adequacy of the bowel preparation for a sigmoidoscopy, colonoscopy or DCBE.
LENGTH: 1
FIELD LOCATION: 306
TYPE: Numeric
SKIP PATTERN: This field should be completed if Item 6.3.01 (Test 3 performed) = 3 (Sigmoidoscopy), 4 (Colonoscopy), 5 (DCBE) or 7 (Other); otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: Adequacy
of the bowel preparation will be determined by the clinician
performing the test. A response of 1 (Yes) or 2 (No) can only be
reported if the procedure report explicitly states that the bowel
preparation was adequate or inadequate; otherwise report 9
(Unknown).
If Test 3 = 7 (Other) and the procedure does
not require bowel preparation, please code the adequacy of bowel
preparation as 9 (Unknown).
If the adequacy of bowel
preparation = 2 (No), then Item 6.3.09 (Test outcome) should be
coded as 2 (Incomplete/Inadequate).
The standardized colonoscopy reporting and data system (CO-RADs) quality measure for adequacy of bowel prep is described as adequacy to detect polyps > 5 mm.
EXAMPLE: If procedure report indicates adequate bowel preparation: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.08: Was the cecum reached during the colonoscopy?
PURPOSE: To indicate whether or not the procedure notes report that the cecum was reached during the colonoscopy.
LENGTH: 1
FIELD LOCATION: 307
TYPE: Numeric
SKIP PATTERN: This field should be completed if Item 6.3.01 (Test 3 performed) = 4 (Colonoscopy); otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: The
procedure report must explicitly state that the cecum was reached or
not reached during the colonoscopy in order to report 1 (Yes) or 2
(No); otherwise, report 9 (Unknown).
If Item 6.3.08 is 2
(No), then Item 6.3.09 (Test 3 outcome) should be coded as 2
(Incomplete/Inadequate).
EXAMPLE: If cecum was not reached: 2
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.01 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.09: Test 3 outcome
PURPOSE: To indicate if the third test was complete.
LENGTH: 1
FIELD LOCATION: 308
TYPE: Numeric
SKIP PATTERN: This
field should be completed when Item 6.3.01 (Test 3 performed) is not
= 0 (None).
If Item 6.3.05 (Result of Test 3) = 4
(Inadequate/Incomplete test with no findings), then Item 6.3.09
should = 2 (Incomplete).
If Item 6.3.05 (Result of Test
2) = 5 (FOBT/FIT/Other Test Performed Negative) or 6 (FOBT/FIT/Other
Test Performed Positive), then Item 6.3.09 should = 1
(Complete).
If Item 6.3.07 (Bowel Prep Adequacy) = 2
(No), then Item 6.3.09 should = 2 (Incomplete).
If Item
6.3.08 (Cecum reached) = 2 (No), then Item 6.3.09 should = 2
(Incomplete).
CONTENTS: 1 =
Complete
2 = Incomplete/Inadequate
EXPLANATION: Each
test provided should have a specific result that is reported in Item
6.3.05. If the test was completed satisfactorily, report 1
(Complete).
If there were circumstances that prevented
the test from being performed satisfactorily such as an obstruction,
inadequate bowel prep, or the cecum was not reached, then report 2
(Incomplete/Inadequate).
If there are multiple polyps,
and some of those polyps are extremely small (< 5mm), it is
acceptable for the provider to choose not to remove the smaller
polyps. In these instances, the Test Outcome would be considered 1
(Complete). If the recommendation of a repeat colonoscopy in 3-6
months is made, then that procedure would begin a new cycle where
the indication (Item 6.0) would be reported as 2 (Surveillance).
If
the provider recommends an immediate repeat exam (or additional
tests needed to come to a Final Diagnosis) due to the incomplete, or
non-removal of a significant polyp, then report 2
(Incomplete/Inadequate). Report the repeat exam (or additional
tests needed) as Test 4.
EXAMPLE: If the colonoscopy is considered complete: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.10: Recommended next follow-up procedure within this cycle after test 3.
PURPOSE: To indicate the next recommended procedure following the completion of Test 3.
LENGTH: 1
FIELD LOCATION: 309
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 6.3.01 (Test 3 performed) is not = 0 (None).
CONTENTS: 1 =
Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to
complete diagnosis
7 = Other
8 = None (cycle is complete)
EXPLANATION: Once Test 3 is completed, the next recommended procedure within the screening cycle should be reported. The next recommended test within the screening cycle would either be a diagnostic test to follow-up a positive initial screening test or another screening test where Test 1 through Test 3 screening tests were incomplete or inconclusive.
If the next
recommended procedure for the client is surgery to complete the
diagnosis, indicate 4 (Surgery). Items 8.1 and 8.2 should then be
completed, along with any final diagnosis and treatment data where
applicable. No further procedures (Item 6.4.01) should be reported.
Item 6.4.01 will be completed with 0 (None).
If Test 3 is normal
and the recommended screening or surveillance test for the next
cycle is FOBT or FIT, then indicate 8 (None). The screening cycle
should be considered complete and the next FOBT or FIT should begin
a new CCDE record. Item 6.4.01 should be completed with 0 (None).
There may be rare instances in which it is appropriate for an FOBT or FIT to be reported as Test 4. In these instances Item 6.3.10 should be reported as 7 (Other). Item 6.3.11 (Other recommended test, specify) should be completed to indicate FOBT or FIT as the recommended next test within the cycle. These instances may include:
FOBT or FIT card could not be read by the lab
Client did not perform FOBT or FIT correctly
An FOBT or FIT is recommended as follow-up to an incomplete or inconclusive colonoscopy that cannot be repeated
EXAMPLE: If a DCBE is recommended as the next procedure within this clients “cycle”: 3
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.3.11: Other recommended test, specify
PURPOSE: To specify the Other test recommended in Item 6.3.10.
LENGTH: 40
FIELD LOCATION: 310 - 349
TYPE: Free text.
SKIP PATTERN: This field should be completed when Item 6.3.10 is reported as 7 (Other). Otherwise, leave blank.
EXPLANATION: This field captures the type of “other” test indicated in Item 6.3.10. Use this item appropriately. Reclaiming inappropriate “other” responses is time consuming and could potentially result in the loss of valuable data.
EXAMPLE: If the next recommended test is a virtual colonoscopy: virtual colonoscopy
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.01: Test 4 performed
PURPOSE: To indicate the fourth test received by the client within the current cycle.
LENGTH: 1
FIELD LOCATION: 350
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 5.2 (Screening Adherence) = 1 (Test Performed).
CONTENTS: 0 = None
3
= Sigmoidoscopy
4 = Colonoscopy
5 = Double-contrast Barium
Enema (DCBE)
7 = Other
EXPLANATION: This field should be reported with the fourth test received by the client within the current cycle.
EXAMPLE: If the fourth test provided to the client is a DCBE: 5
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.02: Test 4 performed – Other specify
PURPOSE: To specify the type of “other” test indicated in Item 6.4.01 (Test 4).
LENGTH: 40
FIELD LOCATION: 351 - 390
TYPE: Free text
SKIP PATTERN: This field should be completed when Item 6.4.01 (Test 4 performed) = 7 (Other). Otherwise, leave blank.
EXPLANATION: This field captures the type of “other” test indicated in Item 6.4.01. Use this item appropriately. Reclaiming inappropriate “other” responses is time consuming and could potentially result in the loss of valuable data.
EXAMPLE: If a virtual colonoscopy is performed: virtual colonoscopy
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.03: Date of Test 4
PURPOSE: To specify the date of the fourth test.
LENGTH: 8
FIELD LOCATION: 391 - 398
TYPE: Date
SKIP PATTERN: This field should be completed when Item 6.4.01 (Test 4 performed) is not = 0 (None).
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is month from 01 to 12, DD is the day from 01 to 31, and YYYY is the year of the test, including the century. If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 08 2010). This field should not be left completely blank if a second test was performed.
EXPLANATION: This
field captures the date that Test 4 is performed.
EXAMPLE: If
a colonoscopy is performed on August 1, 2010: 08012010
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.04: Provider specialty
PURPOSE: To report the specialty of the clinician providing the fourth test.
LENGTH: 2
FIELD LOCATION: 399 - 400
TYPE: Numeric - right justify
SKIP PATTERN: This field should be completed when Item 6.4.01 (Test 4 performed) is not = 0 (None).
CONTENTS: 1 =
General practitioner
2 = Internist
3 = Family
practitioner
4 = Gastroenterologist
5 = General
surgeon
6 = Colorectal surgeon
7 = Licensed practical
nurse
8 = Registered nurse
9 = Nurse practitioner
10
= Physician assistant
12 = Radiologist
13 =
Obstetrician/Gynecologist (OB/GYN)
99 = Unknown
EXPLANATION: This field should capture the medical practice specialty of the provider who performed or provided the first test reported in Item 6.4.01.
EXAMPLE: If the provider specialty for the fourth test is a general surgeon: 5
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.05: Result of Test 4
PURPOSE: To specify the results of Test 4.
LENGTH: 1
FIELD LOCATION: 401
TYPE: Numeric
SKIP PATTERN: This
field should be completed when Item 6.4.01 (Test 4 performed) is not
= 0 (None).
If Item 6.4.01 = 3 (Sigmoidoscopy), 4
(Colonoscopy) or 5 (DCBE), then Item 6.4.05 must = 1 - 4, 7 or
9.
If Item 6.4.01 = 7 (Other), then Item 6.4.05 must be
reported using the result that is appropriate for the test performed
and specified in Item 6.4.02.
CONTENTS: 1 =
Normal/Negative/Diverticulosis/Hemorrhoids
2 = Other finding
not suggestive of cancer or polyp(s)
3 = Polyp(s), or
Lesion(s) suspicious for cancer
4 = Inadequate/Incomplete test
with no findings
5 = FOBT/FIT/Other Test Performed Negative
6
= FOBT/FIT/Other Test Performed Positive
7 = Pending
9 =
Unknown
EXPLANATION: If more
than one result is noted on the medical chart, then report the most
severe.
A response of 2 (Other finding not suggestive of
cancer or polyp(s) should be used when the endoscopy report
indicates a specific finding, but the finding is not a cancerous
lesion or a polyp.
A result of 4 (Inadequate/Incomplete)
should only be reported when the endoscopy report notes that an exam
was started but was incomplete or inadequate, and does not report
any specific findings. Incomplete or inadequate tests may occur due
to client discomfort or distress, bowel obstruction, inadequate
bowel preparation (the bowel was not adequately cleared of fecal
material) or physician fatigue.
If the endoscopy report notes specific findings, even during an incomplete or inadequate test, then the test result should reflect the observations and be reported using response options 1, 2 or 3.
When a Test Result = 4 (Inadequate/Incomplete), then Item 6.1.09 (Test Outcome) should be coded as 2 (Incomplete/Inadequate) and an additional test should be recommended.
EXAMPLE: If result of the colonoscopy is normal: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.06: Was a biopsy/polypectomy performed during the endoscopy?
PURPOSE: To indicate if biopsy or polypectomy was performed during the sigmoidoscopy or colonoscopy.
LENGTH: 1
FIELD LOCATION: 402
TYPE: Numeric
SKIP PATTERN: If Item 6.4.06 = 1 (Yes), then Item 7.1 (Histology of most severe polyp/lesion) must be completed.
Leave blank if 6.4.01 = 0, 5 or 7.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: This
field should only be completed if the fourth test provided is either
a colonoscopy or sigmoidoscopy.
If a biopsy was
performed (1), then Item 7.1 (Histology of most severe polyp/lesion)
must be completed.
EXAMPLE: If a polypectomy was performed during a colonoscopy: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.07: Was the bowel preparation considered adequate by the clinician performing the endoscopy or DCBE?
PURPOSE: To indicate the adequacy of the bowel preparation for a sigmoidoscopy, colonoscopy or DCBE.
LENGTH: 1
FIELD LOCATION: 403
TYPE: Numeric
SKIP PATTERN: This field should be completed if Item 6.4.01 (Test 4 performed) = 3 (Sigmoidoscopy), 4 (Colonoscopy), 5 (DCBE) or 7 (Other); otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: Adequacy
of the bowel preparation will be determined by the clinician
performing the test. A response of 1 (Yes) or 2 (No) can only be
reported if the procedure report explicitly states that the bowel
preparation was adequate or inadequate; otherwise report 9
(Unknown).
If Test 1 = 7 (Other) and the procedure does
not require bowel preparation, please code the adequacy of bowel
preparation as 9 (Unknown).
If the adequacy of bowel
preparation = 2 (No), then Item 6.4.09 (Test outcome) should be
coded as 2 (Incomplete/Inadequate).
The standardized colonoscopy reporting and data system (CO-RADs) quality measure for adequacy of bowel prep is described as adequacy to detect polyps > 5 mm.
EXAMPLE: If procedure report indicates adequate bowel preparation: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.08: Was the cecum reached during the colonoscopy?
PURPOSE: To indicate whether or not the procedure notes report that the cecum was reached during the colonoscopy.
LENGTH: 1
FIELD LOCATION: 404
TYPE: Numeric
SKIP PATTERN: This field should be completed if Item 6.4.01 (Test 4 performed) = 4 (Colonoscopy); otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: The
procedure report must explicitly state that the cecum was reached or
not reached during the colonoscopy in order to report 1 (Yes) or 2
(No); otherwise, report 9 (Unknown).
If Item 6.4.08 is 2
(No), then Item 6.4.09 (Test 4 outcome) should be coded as 2
(Incomplete/Inadequate).
EXAMPLE: If cecum was not reached: 2
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.01 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.09: Test 4 outcome
PURPOSE: To indicate if the fourth test was complete.
LENGTH: 1
FIELD LOCATION: 405
TYPE: Numeric
SKIP PATTERN: This
field should be completed when Item 6.4.01 (Test 4 performed) is not
= 0 (None).
If Item 6.4.05 (Result of Test 4) = 4
(Inadequate/Incomplete test with no findings), then Item 6.4.09
should = 2 (Incomplete).
If Item 6.4.05 (Result of Test
2) = 5 (FOBT/FIT/Other Test Performed Negative) or 6 (FOBT/FIT/Other
Test Performed Positive), then Item 6.4.09 should = 1
(Complete).
If Item 6.4.07 (Bowel Prep Adequacy) = 2
(No), then Item 6.4.09 should = 2 (Incomplete).
If Item
6.4.08 (Cecum reached) = 2 (No), then Item 6.4.09 should = 2
(Incomplete).
CONTENTS: 1 =
Complete
2 = Incomplete/Inadequate
EXPLANATION: Each
test provided should have a specific result that is reported in Item
6.4.05. If the test was completed satisfactorily, report 1
(Complete).
If there were circumstances that prevented
the test from being performed satisfactorily such as an obstruction,
inadequate bowel prep, or the cecum was not reached, then report 2
(Incomplete/Inadequate).
If there are multiple polyps,
and some of those polyps are extremely small (< 5mm), it is
acceptable for the provider to choose not to remove the smaller
polyps. In these instances, the Test Outcome would be considered 1
(Complete). If the recommendation of a repeat colonoscopy in 3-6
months is made, then that procedure would begin a new cycle where
the indication (Item 6.0) would be reported as 2 (Surveillance).
EXAMPLE: If the colonoscopy is considered complete: 1
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 6.4.10: Recommended next follow-up procedure within this cycle after test 4.
PURPOSE: To indicate the next recommended procedure following the completion of Test 4.
LENGTH: 1
FIELD LOCATION: 406
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 6.4.01 (Test 4 performed) is not = 0 (None).
CONTENTS: 4 =
Surgery to complete diagnosis
8 = None (cycle is complete)
EXPLANATION: Once Test 4 is completed, the next recommended procedure within the screening cycle should be reported.
If the next
recommended procedure for the client is surgery to complete the
diagnosis, indicate 4 (Surgery). Items 8.1 and 8.2 should then be
completed, along with any final diagnosis and treatment data where
applicable.
If Test 4 was normal and the next test
recommended is a screening exam (FOBT or FIT), indicate 8 (None).
The screening cycle would be completed and the new screening test
will begin a new CCDE record.
EXAMPLE: If no further tests are recommended within this clients “cycle”: 8
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 7.1: Histology of the most severe polyp or lesion
PURPOSE: Report the worst histology of all biopsies and polypectomies performed during this cycle.
LENGTH: 2
FIELD LOCATION: 407 - 408
TYPE: Numeric - right justify
SKIP PATTERN: This field should be completed if a biopsy or polypectomy was performed during any of Test 1 – 4 [Item 6.x.06 = 1 (Yes)].
CONTENTS: 1
= Normal or other non-polyp histology
2 = Non-adenomatous
polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic
polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 =
Adenoma, mixed tubular villous (no high grade dysplasia
noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 =
Adenoma with high grade dysplasia (includes in situ
carcinoma)
10 = Adenocarcinoma, invasive
11 = Cancer,
other
99 = Unknown/other lesions ablated, not retrieved or
confirmed
EXPLANATION: Report
the most severe histology result found across all pathology for Test
1 through Test 4 when a biopsy or polypectomy was performed during
endoscopy. Do not include histology results from surgical resection.
Histology from surgical resection should be reported in Item
8.1.
Do not update or change the histology reported for
this variable if polyp with high grade dysplasia is determined to be
cancer during a subsequent surgery.
If the worst histology
includes any of the adenoma diagnoses (4-11), then Items 7.2 and 7.3
must be completed.
EXAMPLE: If the histology for the polyp/lesion removed is carcinoma: 11
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
The following table was designed to assist grantees in mapping specific ICD-O morphology codes to the CCDE Histology categories.
CCDE Colorectal Histology Categories |
International Classification of Disease for Oncology, 3rd Edition, Acceptable Morphology Codes and Terminology from Common Codes |
|
1=Normal or other non-polyp histology |
n/a |
|
2=Non-adenomatous polyp (inflammatory, hamartomatous, etc.) |
n/a |
|
3=Hyperplastic polyp |
n/a |
|
4=Adenoma, NOS (no high-grade dysplasia noted) |
8140-8147, 8160-8162, 8180-8210, 8212, 8214-8221, 8250-8260, 8262, 8264-8506, 8520-8550, 8560, 8570-8573, 8940-8941 (with behavior codes of /0) |
|
8140/0 |
Adenoma, NOS |
|
8210/0 |
Adenomatous polyp, NOS |
|
|
8212/0 |
Flat adenoma |
|
8220/0 |
Adenomatous polyposis coli |
|
8221/0 |
Multiple adenomatous polyps |
5=Adenoma, tubular (no high-grade dysplasia noted) |
8211 (with behavior code of /0) |
|
|
8211/0 |
Tubular adenoma, NOS |
6=Adenoma, mixed tubular villous (no high-grade dysplasia noted) |
8263 (with behavior code of /0) |
|
|
8263/0 |
Tubulovillous adenoma, NOS |
7=Adenoma, villous (no high-grade dysplasia noted) |
8261 (with behavior code of /0) |
|
|
8261/0 |
Villous adenoma, NOS |
8=Adenoma, serrated (no high-grade dysplasia noted) |
8213 (with behavior code of /0) |
|
|
8213/0 |
Serrated adenoma |
9=Adenoma with high-grade dysplasia (includes in situ carcinoma) |
8140-8147, 8160-8162, 8180-8221, 8250-8506, 8520-8550, 8560, 8570-8573, 8940-8941 (with behavior codes of /2) |
|
|
8140/2 |
Adenocarcinoma in situ, NOS |
|
8210/2 |
Adenocarcinoma in situ in adenomatous polyp |
|
8261/2 |
Adenocarcinoma in situ in villous adenoma |
|
8263/2 |
Adenocarcinoma in situ in tubulovillous adenoma |
10=Adenocarcinoma, invasive |
8140-8147, 8160-8162, 8180-8221, 8250-8506, 8510, 8520-8550, 8560, 8570-8573, 8940-8941 (with behavior codes of /3) |
|
|
8140/3 |
Adenocarcinoma, NOS |
|
8141/3 |
Scirrhous adenocarcinoma |
|
8210/3 |
Adenocarcinoma in adenomatous polyp
|
10=Adenocarcinoma, invasive (continued) |
8211/3 |
Tubular adenocarcinoma |
|
8214/3 |
Parietal cell carcinoma |
|
8220/3 |
Adenocarcinoma in adenomatous polyposis coli |
|
8221/3 |
Adenocarcinoma in multiple adenomatous polyps |
|
8260/3 |
Papillary adenocarcinoma, NOS |
|
8261/3 |
Adenocarcinoma in villous adenoma |
|
8262/3 |
Villous adenocarcinoma |
|
8263/3 |
Adenocarcinoma in tubulovillous adenoma |
|
8470/3 |
Mucinous cystadenocarcinoma, NOS |
|
8480/3 |
Mucinous adenocarcinoma |
|
8481/3 |
Mucin-producing adenocarcinoma |
|
8490/3 |
Signet ring cell carcinoma |
|
8560/3 |
Adenosquamous carcinoma |
|
8570/3 |
Adenocarcinoma with squamous metaplasia |
|
8571/3 |
Adenocarcinoma with cartilaginous and osseous metaplasia |
|
8940/3 |
Mixed tumor, malignant, NOS |
|
8941/3 |
Carcinoma in pleomorphic adenoma |
11=Cancer, other |
8000-8139, 8148-8159, 8163-8179, 8222-8249, 8507-8509, 8511-8519, 8551-8559, 8561-8569, 8574-8939, 8942-9989 (with behavior codes of /3) |
|
|
8001/3 |
Tumor cells, malignant |
|
8002/3 |
Malignant tumor, small cell type |
|
8004/3 |
Malignant tumor, spindle cell type |
|
8005/3 |
Malignant tumor, clear cell type |
|
8050/3 |
Papillary carcinoma, NOS |
|
8070/3 |
Squamous cell carcinoma, NOS. |
|
8240/3 |
Carcinoid tumor, NOS |
|
8249/3 |
Atypical carcinoid tumor |
ITEM NO / NAME: 7.2: Total number of adenomatous polyps/lesions
PURPOSE: To indicate the total number of adenomatous polyps/lesions removed or biopsied through all endoscopy procedures during the client’s “cycle”. Do not report specimens from surgical resections.
LENGTH: 2
FIELD LOCATION: 409 - 410
TYPE: Numeric - right justify
SKIP PATTERN: If Item 7.1 (Histology of most severe polyp/lesion) is an adenoma or cancer (4-11), then Item 7.2 should be completed; otherwise, leave blank.
CONTENTS: 01 = One
adenomatous polyp/lesion removed or biopsied
02 = Two
adenomatous polyps/lesions removed or biopsied
…
97
= ≥ Ninety-seven adenomatous polyps/lesions removed or
biopsied
98 = At least one adenomatous polyp/lesion removed or
biopsied,
exact number not known
99 = Unknown
EXPLANATION: The
actual number of adenomatous polyps or lesions removed should be
acquired for each test provided. In the case of a large cancer or
lesion which cannot be removed during endoscopy, the endoscopist may
biopsy the area to obtain a specimen for pathology. Include these
specimens when counting the total number of all adenomatous polyps or
lesions removed or biopsied and report in Item 7.2.
When
more than 97 adenomatous polyps or lesions are removed or biopsied
during endoscopy, report 97 (≥ 97 polyps/lesions).
If
the report indicates adenomatous polyps or lesions were removed or
biopsied, but no definite account of the number removed is available,
indicate 98 (At least one polyp/lesion, exact number not known).
If
it is unknown whether any adenomatous polyps or lesions were removed
or biopsied, code 99 (Unknown).
EXAMPLE: If 8 adenomatous polyps/lesions are noted: 08
REVISION HISTORY:
CCDE version |
Date of revision |
Type of revision |
1.00 |
12/02/2009 |
Add new |
ITEM NO / NAME: 7.3: Size of largest adenomatous polyp/lesion
PURPOSE: To report
the size of the largest adenomatous polyp or lesion reported across
all endoscopy procedures performed within the cycle. Do not report
specimens from surgical resections.
LENGTH: 1
FIELD LOCATION: 411
TYPE: Numeric – right justify
SKIP PATTERN: If Item 7.1 (Histology of most severe polyp/lesion) is an adenoma or cancer (4-11), then Item 7.3 should be completed; otherwise, leave blank.
CONTENTS: 1 = < 1
cm
2 =
1 cm
9 = Unknown
EXPLANATION: Report
the diameter of the polyp/lesion in centimeters (cm) or the longest
dimension of the polyp/lesion. This should be the size of the actual
polyp and not the size of the biopsy specimen submitted for
pathology. Do not include information from any surgical
resection.
There
may be instances when a lesion is biopsied, but not removed during
endoscopy. The size of such lesions should also be taken into
consideration when reporting the size of the largest adenomatous
polyp or lesion.
Size
may be found on both the endoscopy and pathology reports, but size
from the endoscopy report is preferred. If the specimen is not
intact when sent to the pathology lab, do not report specimen size
from the pathology report.
EXAMPLE: If the size of the lesion is 2 cm: 2
REVISION HISTORY:
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Type of revision |
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ITEM NO / NAME: 8.1: Histology from surgical resection
PURPOSE: To report the worst histopathology from the surgical resection reported in Item 6.x.10 (where x is either the 1st, 2nd, 3rd or 4th test reported in Section 6) if the client underwent surgery to complete the diagnosis.
LENGTH: 2
FIELD LOCATION: 412 - 413
TYPE: Numeric - right justify
SKIP PATTERN: If Item 6.x.10 is 4 (Surgery to complete diagnosis), then this field should be completed; otherwise, leave blank.
CONTENTS: 0 =
Surgery recommended but not performed
1 = Normal or
other non-polyp histology
2 = Non-adenomatous polyp
(inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma,
tubular (no high grade dysplasia noted)
6 = Adenoma, mixed
tubular villous (no high grade dysplasia
noted)
7
= Adenoma, villous (no high grade dysplasia noted)
8 =
Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma
with high grade dysplasia (includes in situ
carcinoma)
10 = Adenocarcinoma, invasive
11 = Cancer,
other
99 = Unknown/other lesions ablated, not retrieved or
confirmed
NOTE: For guidance on converting ICD-O morphology to CCDE histology from surgical resection, refer to the table following Item 7.1 (Histology of most severe polyp/lesion).
EXPLANATION: Most
often, if a polyp is detected during endoscopy, it can be removed
during the endoscopy and the client will not need surgery to complete
the diagnosis. On some occasions, if the polyp is large or the
lesion is suspicious for cancer, a biopsy will be taken, but the
lesion will not be removed in its entirety during the endoscopy.
Instead, it will be removed during a subsequent surgery to complete
the diagnosis.
Report the worst histopathological
diagnosis made from surgical resection. The response options are
listed in general order of severity. If more than one surgical
resection was performed to obtain a final diagnosis, all of the
resections performed should be considered when determining the worst
histopathological diagnosis.
If surgery was
recommended in Item 6.x.10 (Recommended next follow-up procedure
within the cycle), but was not performed, code 0 (Surgery recommended
but not performed). If no surgery was recommended in Item 6.x.10,
then Item 8.1 should be left blank.
If the histology from
surgical resection is not found in the pathology report, indicate 99
(Unknown).
Use the histology from surgical resection in
conjunction with Item 7.1 (Histology of most severe polyp/lesion)
when reporting the final diagnosis (Item 9.02).
EXAMPLE: If the histology for the polyp/lesion removed is cancer, other: 11
REVISION HISTORY:
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ITEM NO / NAME: 8.2: Date surgery performed
PURPOSE: To indicate the date of the surgical resection to complete the diagnosis.
LENGTH: 8
FIELD LOCATION: 414 - 421
TYPE: Date
SKIP PATTERN: If 8.1 = 1-11, 99 then complete this field; otherwise, leave blank.
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is the month of surgery from 01 to 12, DD is the day of surgery from 01 to 31, and YYYY is the year of the surgery, including the century. If just the year is known, blank fill the month and day. If just the year and month are known, blank fill the day (e.g. 08 2010).
EXPLANATION: This
field captures the date that the surgery to complete diagnosis was
performed. If more than one surgical resection was performed to
obtain a final diagnosis, then report the date of the surgery which
provided the final diagnosis (Item 9.02).
Frequently, the
screening cycle will conclude with endoscopy and surgery will not be
required to complete the diagnosis. Surgery to complete the final
diagnosis will only be performed if a suspicious polyp or lesion
could not be completely removed during endoscopy.
If Item
8.1 = 0 (Surgery recommended but not performed), then this field
should be left blank.
EXAMPLE: If a surgery was performed on August 1, 2010: 08012010
REVISION HISTORY:
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ITEM NO / NAME: 9.01: Status of final diagnosis
PURPOSE: To specify the status of final diagnosis for a cycle after all screening and diagnostic tests are performed/offered to the client.
LENGTH: 1
FIELD LOCATION: 422
TYPE: Numeric
SKIP PATTERN: This field should be completed when Item 5.2 (Screening adherence) is reported as 1 (performed); otherwise, leave blank.
CONTENTS: 1 =
Complete (final diagnosis determined)
2 = Pending final
diagnosis
3 = Client refused diagnostic follow-up
4 =
Client lost to follow-up before final diagnosis was made
5 =
Irreconcilable.
EXPLANATION: Report
the status of the client’s care after all screening and
diagnostic tests are performed/offered to the client.
If a
client receives a single screening test, and that test is
normal/negative, then complete this field as 1 (Complete).
A
status of 2 (Pending final diagnosis) indicates that not all of the
planned tests have been completed and therefore a final diagnosis has
not yet been determined. A record should not be pending for more
than one year. Such records should be monitored so that as a
client’s tests are completed, and a final diagnosis is made,
this field may be updated to the appropriate status of final
diagnosis.
A status of 3 (Client refused diagnostic
follow-up) should be reported if a client severs his or her
relationship with the Program. For example, a client may decline the
recommended tests, or may choose to have the tests performed by a
provider outside of the Program. While such cases are simply
reported to the CDC as 3 (Refused) in the CCDE file, Grantees should
track more detailed information about each “refused”
case.
A status of 4 (Client lost to follow-up) should be
reported if prior to the completion of all recommended tests, a
client moves to a location beyond the Program’s range of
service delivery, or the client can no longer be located by the
grantee. A status of 4 (Lost to Follow-up) should also be reported
if a client dies prior to the completion of all recommended tests.
Lost to follow-up should be reported when tracking efforts have been
attempted in accordance with the grantee’s written protocol,
but were unsuccessful. Again, while such cases are simply reported
to the CDC as 4 (Lost to Follow-up) in the CCDE file, grantees should
track more detailed information about each “lost”
case.
All grantees must have a policy in place to define
how much time can elapse before the client is considered 3 (Refused)
or 4 (Lost to follow-up). The CDC realizes that in many cases
attempts to contact a client occur well beyond the closure of a
record as lost to follow-up or refused. In the event that these
efforts are successful and the client returns to the Program after
the record was closed as lost to follow-up or refused, the grantee
should consult with the client’s clinician and its Medical
Advisory Board to determine if the client‘s previous cycle of
care should resume, or if a new cycle of care should begin.
A status of 5
(Irreconcilable) should be used for records which after clinical
review, it was determined that there was no sufficient way to
translate the clinical scenario into the CCDE data record. For
example, a clinician might refer a client for a short-term recall
instead of following the clinical guidelines for immediate diagnostic
work-up. In such cases, enter “5” to indicate a cycle
that has been reviewed and subsequently closed with an irreconcilable
status.
It is recommended that grantees do not include
irreconcilable status of final diagnosis on their CCDE data
collection forms for providers to select. The intent of
irreconcilable status of final diagnosis is for administrative use at
your Program’s central data location, and not at the provider
level. Its intended use is to help grantees manage the records in
the Feedback Reports that need to be reviewed and reconciled.
However, records closed using an irreconcilable status of final
diagnosis will still be regarded as records with incomplete follow-up
in analyses of completeness.
EXAMPLE: If status of client’s care for the current CCDE record is complete: 1
REVISION HISTORY:
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ITEM NO / NAME: 9.02: Final diagnosis
PURPOSE: To specify the final diagnosis after all tests have been completed.
LENGTH: 1
FIELD LOCATION: 423
TYPE: Numeric
SKIP PATTERN: If Item
9.01 (Status of final diagnosis) is 1 (Complete), then this field
should be completed; otherwise, leave blank.
CONTENTS: 1 =
Normal/Negative
2 = Hyperplastic polyps
3 = Adenomatous
polyp, no high grade dysplasia
4 = Adenomatous polyp with high
grade dysplasia
5 = Cancer
EXPLANATION: After
all screening and diagnostic tests are performed or offered to the
client, report the final diagnosis that the clinician will use to
determine the re-screening or surveillance test recommendation. In
some cases, polyps or lesions may be removed during differing
procedures, with each procedure resulting in a different histology.
Report the worst diagnosis (among all procedures performed) as the
final diagnosis.
If the only test performed in the
screening cycle (Item 6.1.01) was an FOBT or FIT that was negative,
and Item 9.01 (Status of final diagnosis) = 1 (complete), then
complete this field as 1 (Normal/Negative).
Section 10
(Treatment Information) should be completed if Item 9.02 (Final
Diagnosis) = 5 (Cancer). Treatment information may be completed if
Item 9.02 = 4 (Adenomatous Polyp with high grade dysplasia) and
treatment was recommended by the clinician.
Section 11
(Registry Information for Cancer/High Grade Dysplasia) should be
completed if Item 9.02 (Final Diagnosis) = 4 (Adenomatous polyp with
high grade dysplasia) or 5 (Cancer).
EXAMPLE: If the final diagnosis is Normal: 1
REVISION HISTORY:
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ITEM NO / NAME: 9.03: Date of final diagnosis
PURPOSE: To specify the date of final diagnosis.
LENGTH: 8
FIELD LOCATION: 424 - 431
TYPE: Date
SKIP PATTERN: This field should be completed if Item 9.01 (Status of final diagnosis) is 1 (Complete), 3 (Refused), 4 (Lost to follow-up) or 5 (Irreconcilable); otherwise, it should be blank.
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is the month of diagnosis from 01 to 12, DD is the day of diagnosis from 01 to 31, and YYYY is the year of diagnosis. If any part of the date is unknown, blank-fill only that part. For example, if the month and year of diagnosis are known, but the day is not, then blank-fill the day (e.g. 08 2010).
EXPLANATION: This field should indicate the date of the procedure that provided the final diagnosis (which may include the date of the “normal” screening test). If more than one procedure was performed to obtain a final diagnosis, report the date of the procedure which provided the worst histologic diagnosis. In some cases the first of multiple tests may provide the date of final diagnosis.
If the client refused tests, or was determined to be lost to follow-up, then an administrative close-out date should be reported as the date of final diagnosis. If the client moved before all tests were completed and a final diagnosis could not be obtained, then an administrative close-out date should be reported as the date of final diagnosis.
EXAMPLE: If the date of the final pathology report is July 15, 2010: 07152010
REVISION HISTORY:
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ITEM NO / NAME: 9.04: Recommended screening or surveillance test for next cycle
PURPOSE: To indicate the next recommended test for the client at the end of the “cycle”.
LENGTH: 1
FIELD LOCATION: 432
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 9.01 does not = 1.
CONTENTS: 1 =
Take-home FOBT
2 = Take-home FIT
3 = Sigmoidoscopy
4 =
Colonoscopy
5 = DCBE
8 = None
9 = Unknown
EXPLANATION: Report
the next screening or surveillance test recommended to the client at
the end of the cycle. Examples include a surveillance colonoscopy
following a previous abnormal colonoscopy and/or surgery, or the next
screening test recommended to the client following a normal/negative
test.
If client is terminally ill, or for other reasons no
further tests are recommended by the clinician, then code this item
as 8 (None).
EXAMPLE: If a FOBT is recommended as the test to begin the next cycle: 1
REVISION HISTORY:
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ITEM NO / NAME: 9.05: Indication for screening or surveillance test for next cycle
PURPOSE: To report the indication for the next test recommended to the client.
LENGTH: 1
FIELD LOCATION: 433
TYPE: Numeric
SKIP PATTERN: Leave
blank if Item 9.01 (Status of final diagnosis) does not =1
(Complete).
Leave blank if Item 9.04 (Recommended
screening or surveillance test for next cycle) = 8 (None) or 9
(Unknown).
CONTENTS: 1 =
Screening
2 = Surveillance after a positive colonoscopy and/or
surgery
EXPLANATION: If a test was recommended in Item 9.04, then the indication for the test (screening vs. surveillance) should be reported.
Grantees should encourage their providers to make re-screening and surveillance frequency recommendations based on published guidelines, when available.
EXAMPLE: If the next recommended test is a screening test: 1
REVISION HISTORY:
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ITEM NO / NAME: 9.06: Number of months before screening or surveillance test for next cycle.
PURPOSE: To indicate the recommended interval between Item 9.03 (Date of final diagnosis) and the next recommended screening/surveillance test.
LENGTH: 3
FIELD LOCATION: 434 - 436
TYPE: Numeric - right justify
SKIP PATTERN: Leave blank if Item 9.01 does not = 1 (Complete).
Leave
blank if Item 9.04 (Recommended screening or
surveillance test for next cycle) = 8 (None) or 9 (Unknown).
CONTENTS: 12 =
Twelve months
13 = Thirteen months
…
180 =
One hundred eighty months
999 = Unknown
EXPLANATION: If a test was recommended in Item 9.04, then the report the interval between the final diagnosis and the next test date. If Item 9.04 is reported as 8 (None) or 9 (Unknown), this field should be left blank.
EXAMPLE: If the recommended interval before the next test is two years: 24
REVISION HISTORY:
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ITEM NO / NAME: 9.07: Complications (1) of endoscopy or DCBE requiring observation or treatment
PURPOSE: To indicate if there was a complication that occurred due to a DCBE or endoscopy procedure.
LENGTH: 2
FIELD LOCATION: 437 - 438
TYPE: Numeric - right justify
SKIP PATTERN: If Item
6.x.01 (Test Performed) was 3 (Sigmoidoscopy), 4 (Colonoscopy), 5
(DCBE) or 7 (Other) then this field should be completed; otherwise,
leave blank.
CONTENTS: 0 = No
complications reported
1 = Bleeding requiring transfusion
2 = Bleeding not requiring transfusion
3 = Cardiopulmonary
events (hypotension, hypoxia, arrhythmia,
etc.)
4
= Complications related to anesthesia
5 = Bowel perforation
6 = Post-polypectomy syndrome/excessive abdominal pain
7 =
Death
8 = Other
99 = Unknown
EXPLANATION: Grantees
may report the worst of up to two distinct serious complications
occurring within 30 days of the test date and resulting in an
emergency room visit, hospitalization or death. One complication
should be reported in Item 9.07, and the other in Item 9.08.
If
there were no complications reported by the client or clinician,
report 0 (No complications reported) in both Items 9.07 and 9.08. If
the client only experienced one complication, report that
complication in Item 9.07 and then report 0 (No complications
reported) in Item 9.08.
If Item 9.07 = 8 (Other), then
Item 9.09 (Complications of endoscopy or DCBE - other specify) should
be completed.
EXAMPLE: If the client experienced bleeding, but did not require a transfusion: 2
REVISION HISTORY:
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ITEM NO / NAME: 9.08: Complications (2) of endoscopy or DCBE requiring observation or treatment
PURPOSE: To indicate a second complication that occurred due to a DCBE or endoscopy procedure.
LENGTH: 2
FIELD LOCATION: 439 - 440
TYPE: Numeric - right justify
SKIP PATTERN: If Item
6.x.01 (Test Performed) was 3 (Sigmoidoscopy), 4 (Colonoscopy), 5
(DCBE) or 7 (Other) then this field should be completed. Otherwise,
leave blank.
CONTENTS: 0 = N/A
– no 2nd complication reported
1 = Bleeding requiring
transfusion
2 = Bleeding not requiring transfusion
3 =
Cardiopulmonary events (hypotension, hypoxia, arrhythmia,
etc.)
4 = Complications related to anesthesia
5 =
Bowel perforation
6 = Post-polypectomy syndrome/excessive
abdominal pain
7 = Death
8 = Other
99 = Unknown
EXPLANATION: Grantees
may report the worst of up to two distinct serious complications
occurring within 30 days of the test date and resulting in an
emergency room visit, hospitalization or death. One complication
should be reported in Item 9.07, and the other in Item 9.08.
If
there were no complications reported by the client or clinician,
report 0 (No complications reported) in both Items 9.07 and 9.08. If
the client only experienced one complication, report that
complication in Item 9.07 and then report 0 (No complications
reported) in Item 9.08.
If Item 9.08 = 8 (Other), then
Item 9.09 (Complications of endoscopy or DCBE - other specify) should
be completed.
EXAMPLE: If the client experienced bleeding, but did not require a transfusion: 2
REVISION HISTORY:
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ITEM NO / NAME: 9.09: Complications of endoscopy or DCBE – Other specify
PURPOSE: To specify the type of “other” complication reported in Item 9.07 or Item 9.08.
LENGTH: 40
FIELD LOCATION: 441 - 480
TYPE: Free text
SKIP PATTERN: If Item
9.07 or Item 9.08 = 8 (Other), then this field should be completed;
otherwise, leave blank.
EXPLANATION: This
field captures the type of “other” complication indicated
in Item 9.07 and/or Item 9.08. Try to use this item appropriately.
Reclaiming inappropriate “other” responses is time
consuming and could potentially result in the loss of valuable data.
Acceptable other complications would include infection (bacteremia or
abscess) or allergic reaction to sedative.
This field
should not be used to report a third complication. It is appropriate
for each grantee to collect as much information as possible about all
complications experienced; however, it is only necessary to report
the two worst complications to the CDC.
EXAMPLE: If the client experienced an infection: Infection
REVISION HISTORY:
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ITEM NO / NAME: 9.10: CRCCP funds used for any screening/diagnostic test?
PURPOSE: To indicate if CRCCP funds were used to pay for any of the screening or diagnostic tests reported in 6.x.01.
LENGTH: 1
FIELD LOCATION: 481
TYPE: Numeric
SKIP PATTERN: If at
least one test was completed, then this field should be completed;
otherwise, leave blank.
CONTENTS: 1 = Yes
2
= No
9 = Unknown
EXPLANATION: If the funding source for the screening or diagnostic test is documented, then a response of 1 (Yes) or 2 (No) should be reported. If the funding source cannot be determined, then a response of 3 (Unknown) should be reported.
EXAMPLE: If the client had an FOBT that was paid for with CRCCP funds: 1
REVISION HISTORY:
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TEM NO / NAME: 10.1: Recurrent cancers
PURPOSE: Indicate if the cancer reported in Item 9.02 (Final Diagnosis) is a new primary, a recurrent cancer, or a non-CRC primary cancer.
LENGTH: 1
FIELD LOCATION: 482
TYPE: Numeric
SKIP PATTERN: If Item 9.02 (Final Diagnosis) is 5 (Cancer), then this field should be completed; otherwise, leave blank.
CONTENTS: 1 = New CRC primary
2 =
Recurrent CRC
3 = Non-CRC primary (metastasis from another
organ)
9 = Unknown
EXPLANATION: If the cancer reported in Item
9.02 is a new primary colorectal cancer, report 1 (New CRC primary).
If the cancer is a metastasis of a non-colorectal primary, then
report it as 3 (Non-CRC primary).
An example of when 9
(Unknown) might be reported is if cells are so poorly differentiated
that the organ of origin cannot be identified. This should occur
rarely.
Grantees will need to work with their Cancer
Registry to determine if a cancer is a new CRC primary, a non-CRC
primary or a recurrent CRC cancer.
EXAMPLE: If the cancer found is a recurrent CRC cancer: 2
REVISION HISTORY:
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ITEM NO / NAME: 10.2: Status of treatment
PURPOSE: To specify the status of standard treatment for any cancer diagnosed.
LENGTH: 1
FIELD LOCATION: 483
TYPE: Numeric
SKIP PATTERN: If Item 9.02 (Final
Diagnosis) = 5 (Cancer), then this field should be completed.
If Item 9.02 = 4 (Adenomatous polyp with high grade dysplasia), then this field may be completed; however, Item 10.2 may not = 3 (Treatment not indicated due to polypectomy), 4 (Treatment not recommended) or 9 (Unknown).
Leave blank if Item 9.02 = 1(Normal/Negative), 2 (Hyperplastic polyps) or 3 (Adenomatous polyp, no high grade dysplasia).
CONTENTS: 1 = Treatment started and/or
completed
2 = Treatment pending
3 = Treatment not indicated
due to polypectomy
4 = Treatment not recommended
5 =
Treatment refused
6 = Lost to follow-up
9 = Unknown
EXPLANATION: For the purpose of this
program, the CDC requires the reporting of standard or conventional
treatments. Non-standard or alternative treatments should not be
reported as 1 (Treatment Started). In the event that the client
chooses a form of non-standard or alternative treatment, this field
should be coded as 5 (Treatment refused).
NOTE:
Experimental drugs, such as those used in clinical trials, may be
reported as 1 (Treatment started).
The fact that a client
is referred for standard treatment is NOT sufficient confirmation
that treatment has been started. A client should be classified as
having started treatment only when the grantee has confirmed that a
plan for standard treatment has been developed and actually started.
The date when standard treatment began refers to the client’s
actual start of therapy.
Endoscopy can often achieve
screening and treatment simultaneously, by detecting and removing a
polyp. A complete polypectomy would be considered both diagnostic
and the only required treatment. In this case, the procedure should
be reported in the Screening and Diagnostic Tests Performed section
(Item 6.x.01), Treatment should be reported as 3 (Treatment not
indicated due to polypectomy), and Item 10.3 (Date of Treatment) will
be the day of the polypectomy. In this instance, Item 9.03 (Date of
final diagnosis) and Item 10.3 (Date of treatment) would be the same.
In the circumstance that surgical removal
of a polyp or cancer (to complete a diagnosis) is complete, with no
evidence of spreading, the surgery would also be considered both
diagnostic and the only required treatment. In this case, the date
of surgery should be reported in Item 8.2 (Date of Surgery),
Treatment should be 3 (Treatment not indicated due to polypectomy),
and Item 10.3 (Date of Treatment) will be the day of the surgery.
If any additional treatment beyond a polypectomy or
surgery is required because of local or distant spread of a cancer
(e.g. chemotherapy or radiation therapy), the Status of Treatment and
Date of Treatment need to be determined by the start of the standard
or conventional treatment beyond that of the polypectomy or surgery.
Each grantee must have a policy in place
to define how much time can elapse before the client is considered 5
(Treatment refused) or 6 (Lost to follow-up).
EXAMPLE: If client refused treatment: 5
REVISION HISTORY:
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ITEM NO / NAME: 10.3: Date of treatment
PURPOSE: To report the date treatment began.
LENGTH: 8
FIELD LOCATION: 484 - 491
TYPE: Date
SKIP PATTERN: If Item 10.2 (Status of treatment) = 2 (Treatment pending) or 9 (Unknown), this field must be blank; otherwise it must be completed.
If Item 10.2 (Status of treatment) = 1 (Treatment started and/or completed), 3 (Treatment not indicated due to polypectomy), 4 (Treatment not recommended), 5 (Treatment refused) or 6 (Lost to follow-up), then this item should be completed.
CONTENTS: An 8-digit date field of the form MMDDYYYY, where MM is the month of treatment from 01 to 12, DD is the day of treatment from 01 to 31, and YYYY is the year of treatment, including the century. If any part of the date is unknown, blank-fill only that part. For example, if the month and year of treatment are known, but the day is not, then blank-fill the day (e.g. 08 2010).
EXPLANATION: If Item 10.2 (Status of
Treatment) is 1 (Started), then complete with the date the treatment
began.
The fact that a client is referred for standard
treatment is not sufficient confirmation that treatment has
been started. A client should be classified as having started
treatment only when the grantee has confirmed that a plan for
standard treatment has been developed and actually started. The date
when standard treatment began refers to the client’s actual
start of therapy.
Endoscopy can often achieve screening
and treatment simultaneously, by detecting and removing a polyp. A
complete polypectomy would be considered both diagnostic and the only
required treatment. In this case, the procedure should be reported
in the Screening and Diagnostic Tests Performed section (6.x.01),
Treatment should be reported as 3 (Treatment not indicated due to
polypectomy), and Item 10.3 (Date of Treatment) will be the day of
the polypectomy. In this instance, Item 9.03 (Date of final
diagnosis) and Item 10.3 (Date of Treatment) would be the same.
In
the circumstance that surgical removal of a polyp or cancer (to
complete a diagnosis) is complete, with no evidence of spread, the
surgery would also be considered both diagnostic and the only
required treatment. In this case, the date of surgery should be
reported in Item 8.2 (Date of Surgery), Treatment should be 3
(Treatment not indicated due to polypectomy), and Item 10.3 (Date of
Treatment) will be the day of the surgery.
If any
additional treatment beyond a polypectomy or surgery to complete
diagnosis is required because of local or distant spread of a cancer
(e.g. chemotherapy or radiation therapy), the Status of Treatment and
Date of Treatment need to be determined by the start of the standard
or conventional treatment beyond that of the polypectomy or surgery
to complete diagnosis.
Each grantee must have a policy in
place to define how much time can elapse before the client is
considered 5 (Treatment refused) or 6 (Lost to follow-up).
Each
grantee must have a policy in place to define how much time can
elapse before the client is considered to be “Refused” or
“Lost to follow-up”
EXAMPLE: Client began chemotherapy on December 15, 2010: 12152010
REVISION HISTORY:
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ITEM NO / NAME: 11.01: Registry linkage status
PURPOSE: To indicate if the record for the client reported in Item 9.02 (Final Diagnosis) has been linked to the state/central cancer registry.
LENGTH: 1
FIELD LOCATION: 492
TYPE: Numeric
SKIP PATTERN: This field should only be completed if Item 9.02 (Final Diagnosis) was reported as 4 (Adenomatous Polyp with high grade dysplasia) or 5 (Cancer); otherwise, leave blank.
CONTENTS: 1 = Pending linkage
2 =
Linked, matched
3 = Linked, not matched
EXPLANATION: At the time of each CCDE
submission, this field should be updated to indicate if the record
has been linked to the state/central cancer registry or not.
If
your Program has not linked a record with the Cancer Registry at the
time of the CCDE submission, report this item as 1 (Pending linkage).
If your Program has successfully matched a record with the Cancer Registry at the time of the CCDE submission, report this item as 2 (Linked, matched).
If during the linkage process a record in the CCDEs is NOT identified in the state/central cancer registry (based on matching algorithm guidelines developed by CDC using a combination of client identifiers such as name and date of birth), indicate 3 (Linked, not matched).
EXAMPLE: If the case is matched with a record in the state/central cancer registry: 2
REVISION HISTORY:
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Date of revision |
Type of revision |
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ITEM NO / NAME: 11.02: Registry Date of Diagnosis
PURPOSE: To report the date of diagnosis obtained from the state/central cancer registry.
LENGTH: 8
FIELD LOCATION: 493 - 500
TYPE: Date - MMDDYYYY format
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: An 8-digit date item of the form MMDDYYYY, where MM (month) is the month of diagnosis from 01 to 12, DD (day) is the day of diagnosis from 01 to 31, and YYYY is the year of the diagnosis, including the century. If any part of the date is unknown, blank fill only that part. For example, if the month and year of diagnosis are known, but the day is not, then blank fill the day (e.g. 08 2010).
EXPLANATION: This item should indicate the
date of diagnosis [NAACCR data item # 390] obtained from the
state/central cancer registry.
Please note that Item
9.03 (the Date of Final Diagnosis) and Item 11.02 may differ in many
instances.
EXAMPLE: If the Registry Date of Diagnosis is 08/28/2010: 08282010.
REVISION HISTORY:
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ITEM NO / NAME: 11.03: Registry Histologic Type
PURPOSE: To report the histologic type obtained from the state/central cancer registry.
LENGTH: 4
FIELD LOCATION: 501 - 504
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: Values for Item 11.03 (Registry
Histologic Type) fall within the range of 8000 to 9989.
NOTE:
See Chapter 3 (Registry Linkage) for a list of the most common
histology/behavior codes and their definitions
as reported in the Collaborative Staging Manual Coding
Instructions.
EXPLANATION: If Item 11.01 (Registry linkage status) is reported as 2 (Linked, matched), then report the Registry Histologic Type [NAACCR data item # 522] obtained from the state/central cancer registry database.
EXAMPLE: If the Registry Histologic Type is 8070: 8070.
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ITEM NO / NAME: 11.04: Registry Behavior
PURPOSE: To indicate the behavior code obtained from the state/central cancer registry.
LENGTH: 1
FIELD LOCATION: 505
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: 0 = Benign
1 = Uncertain
whether benign or malignant/Borderline malignancy
2 = Carcinoma,
In Situ
3 = Malignant
NOTE: See Chapter 3
(Registry Linkage) for a list of the most common histology/behavior
codes and their definitions as reported in the Collaborative
Staging Manual Coding Instructions.
EXPLANATION: If Item 11.01 (Registry linkage status) is reported as 2 (Linked, matched), then report the Registry Behavior type [NAACCR data item # 523] obtained from the state/central cancer registry database.
EXAMPLE: If the Registry Behavior indicates “Malignant”: 3
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ITEM NO / NAME: 11.05: Registry primary site
PURPOSE: To report the primary site obtained from the state/central cancer registry.
LENGTH: 4
FIELD LOCATION: 506 - 509
TYPE: Alphanumeric - left justify
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: C000 through C999. The “C”
must be included as part of the variable response.
Chapter
3 (Registry Linkage) contains documentation which provides a table of
available primary site codes as listed in the
topography section of the International Classification of Diseases
for Oncology, Third Edition (ICD-O-3).
EXPLANATION: If Item 11.1 (Registry linkage status) is reported as 2 (Linked, matched), the primary site [NAACCR data item #400] obtained from the cancer registry should be reported.
EXAMPLE: If the primary site is cecum: C180
REVISION HISTORY:
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ITEM NO / NAME: 11.06: Registry CS-derived SS2000
PURPOSE: To report the derived summary stage obtained from the state/central cancer registry.
LENGTH: 1
FIELD LOCATION: 510
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: 0 = In situ
1 = Localized
2
= Regional, direct extension only
3 = Regional, regional lymph
nodes only
4 = Regional, extension and nodes
5 = Regional,
NOS
7 = Distant
8 = Not applicable
9 =
Unknown/unstaged
EXPLANATION: If Item 11.01 (Registry
linkage status) is reported as 2 (Linked, matched), then report the
collaborative stage (CS)-derived summary stage 2001 [NAACCR data item
#3020] obtained from the cancer registry database. Please refer to
the Web site www.cancerstaging.org
for general instructions provided to cancer registry sites on
reporting this information.
Chapter 3 (Registry Linkage)
has additional information for this item.
EXAMPLE: If the registry CS-derived stage is localized: 1
REVISION HISTORY:
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ITEM NO / NAME: 11.07: Registry CS-derived AJCC stage group
PURPOSE: To report the CS-derived AJCC stage group as indicated by the state/central cancer registry.
LENGTH: 3
FIELD LOCATION: 511 – 513
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: Valid values for CS-derived AJCC
stage include: 000, 010, 020, 100, 110, 120, 130, 140, 121, 150, 160,
170, 151, 180, 190, 230, 240, 200, 210, 220, 300, 310, 320, 321, 322,
323, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 500, 510,
520, 530, 540, 541, 542, 550, 560, 570, 580, 590, 600, 610, 620, 630,
700, 710, 720, 721, 722, 730, 740, 888, 900, 999.
NOTE:
See Chapter 3 (Registry Linkage) for a complete list of all
available codes and their definitions as
reported in the Collaborative Staging Manual Coding Instructions.
EXPLANATION: If Item 11.01 (Registry linkage status) is reported as 2 (Linked, matched), then report the collaborative stage (CS)-derived AJCC stage [NAACCR data item #3000] obtained from the cancer registry database.
EXAMPLE: If polyp was diagnosed as a Stage II: 300
REVISION HISTORY:
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ITEM NO / NAME: 11.08: Registry CS extension
PURPOSE: To indicate the extension of disease, as reported by the state/central cancer registry.
LENGTH: 3
FIELD LOCATION: 514 – 516
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: Valid values for CS extension
include: 000, 050, 100, 110, 120, 130, 140, 150, 160, 170, 200, 300,
400, 410, 420, 450, 460, 490, 500, 550, 560, 570, 600, 650, 660, 700,
750, 800, 850, 900, 950, 999.
NOTE: See Chapter 3
(Registry Linkage) for a complete list of all available
codes and their definitions as reported in the Collaborative
Staging Manual Coding Instructions.
EXPLANATION: If Item 11.01 (Registry linkage status) is reported as 2 (Linked, matched), then report the collaborative stage (CS)-derived extension [NAACCR data item #2810] obtained from the cancer registry database.
EXAMPLE: If the CS reported extension for Colon is “Localized, NOS”: 300
REVISION HISTORY:
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ITEM NO / NAME: 11.09: Registry CS lymph nodes
PURPOSE: To indicate the lymph node involvement, as reported by the state/central cancer registry.
LENGTH: 3
FIELD LOCATION: 517 – 519
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: Valid values for CS lymph nodes
are 000, 050, 100, 200, 300, 400, 410, 420, 450, 460, 470, 800, 999.
NOTE: See Chapter 3 (Registry Linkage) for a
complete list of all available codes and their
definitions as reported in the Collaborative Staging Manual Coding
Instructions.
EXPLANATION: If Item 11.01 (Registry linkage status) is reported as 2 (Linked, matched), then report the collaborative stage (CS) lymph node involvement [NAACCR data item #2830] obtained from the cancer registry database.
EXAMPLE: If the primary site is colon, and the lymph nodes involvement reported is “Regional lymph node(s) for ascending colon: 200
REVISION HISTORY:
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ITEM NO / NAME: 11.10: Registry CS mets at diagnosis
PURPOSE: To indicate any distant metastases at the time of diagnosis, as reported by the state/central cancer registry.
LENGTH: 2
FIELD LOCATION: 520 – 521
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: 00, 05, 08, 15, 20, 22, 25, 27,
30, 35, 38, 45, 60, 99.
10, 11, 12, 40 and 50 are valid
but obsolete codes and should be used infrequently.
NOTE:
See Chapter 3 (Registry Linkage) for a complete list of all
available codes and their definitions as
reported in the Collaborative Staging Manual Coding Instructions.
EXPLANATION: If Item 11.01 (Registry linkage status) is reported as 2 (Linked, matched), then report the CS mets at diagnosis [NAACCR data item #2850] obtained from the cancer registry database.
EXAMPLE: If the mets at diagnosis are reported as “None”: 00
REVISION HISTORY:
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ITEM NO / NAME: 11.11: Registry Collaborative Stage (CS) – Tumor Size
PURPOSE: To report the tumor size as indicated by the state/central cancer registry.
LENGTH: 3
FIELD LOCATION: 522 – 524
TYPE: Numeric
SKIP PATTERN: Leave blank if Item 11.01 (Registry linkage status) = 1 (Pending linkage) or 3 (Linked, not matched).
CONTENTS: 001-988 Exact size in
millimeters
989 = ≥ 989 millimeters
990 = Microscopic
focus or foci only; no size of focus is given
991 = Described as
less than 1 cm
992 = Described as between 1 cm and 2 cm
993
= Described as between 2 cm and 3 cm
994 = Described as between
3 cm and 4 cm
995 = Described as between 4 cm and 5 cm
998
= Familial/multiple polyposis
999 = Unknown; size not stated
EXPLANATION: If Item 11.01 (Registry linkage status) is reported as 2 (Linked, matched), then report the Collaborative Stage (CS) Tumor Size [NAACCR data item # 2800] obtained from the state/central cancer registry database.
Not all cancer registries collect this information. If this field is blank in the Cancer Registry, report 999 (Unknown).
EXAMPLE: If CS-Tumor Size was described as between 3 cm and 4 cm: 994
REVISION HISTORY:
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ITEM NO / NAME: 12.1: CCDE version
PURPOSE: To report the CCDE version that the current record was collected in.
LENGTH: 3
FIELD LOCATION: 525 – 527
TYPE: Numeric
SKIP PATTERN: This field should always be completed.
CONTENTS: 100 = All data currently being collected/reported.
EXPLANATION: As the program begins to
evaluate data collected, some variables may be dropped, new variables
may be added, or additional options may be added to variable
responses. As these changes occur, the CCDE version number will
change.
EXAMPLE: Clinical data for a client was collected in March 2010: 100.
REVISION HISTORY:
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CHAPTER 3
Included in this chapter are tables from the SEER Program Coding and Staging Manual 2007 (http://seer.cancer.gov); and the Collaborative Staging Manual and Coding Instructions, version 2.0, jointly published by the American Joint Committee on Cancer (AJCC) and the U.S. Department of Health and Human Services (DHHS) (http://www.cancerstaging.org ).
These cancer staging manuals provide detailed descriptions for the following items in the CCDEs. These tables should be referenced in order to ensure accurate reporting of these variables and their values:
CCDE Item 11.03: Registry Histologic type
CCDE Item 11.04: Registry behavior
CCDE Item 11.05: Registry primary site
CCDE Item 11.06: Registry CS-derived SS2000
CCDE Item 11.07: Registry CS-derived AJCC stage group
CCDE Item 11.08: Registry CS extension
CCDE Item 11.09: Registry CS lymph nodes
CCDE Item 11.10: Registry CS mets at diagnosis
CCDE Item 11.11: Registry CS tumor size
CCDE Item 11.03: Registry Histologic Type and CCDE Item 11.04 Registry Behavior
Registry Histologic Type [NAACCR data item #522] and Behavior [NAACCR data item #523] are often reported together. For example, ‘Adenocarcinoma in situ’ may be reported as ‘8140/2’, where ‘8140’ is the Histologic type, and ‘2’ is the behavior. For the purposes of this data user’s manual, we will provide the International Classification of Disease (ICD) Histology codes (ICD-0-3) that are most commonly associated with colorectal cancer. If Programs receive a Histology/Behavior combination that is not listed below, they should verify the value with their State Central Cancer Registry. The Histology table will include the Histology and Behavior codes together in order to provide a more detailed description of each value.
11.04 Registry Behavior (alone)
-
Value
Description
0
Benign
1
Uncertain whether benign or malignant/Borderline malignancy
2
Carcinoma In Situ
3
Malignant
Histology |
Histology/ Behavior |
Histology/Behavior Description |
|
NEOPLASM |
800 |
8000/3 |
Neoplasm, malignant |
|
|
8001/3 |
Tumor cells, malignant |
|
|
8002/3 |
Malignant tumor, small cell type |
|
|
8003/3 |
Malignant tumor, giant cell type |
|
|
8004/3 |
Malignant tumor, spindle cell type |
|
|
8005/3 |
Malignant tumor, clear cell type |
CARCINOMA, NOS |
801 |
8010/2 |
Carcinoma in situ, NOS |
|
|
8010/3 |
Carcinoma, NOS |
|
|
8011/3 |
Epithelioma, malignant |
|
|
8012/3 |
Large cell carcinoma, NOS |
|
|
8013/3 |
Large cell neuroendocrine carcinoma |
|
|
8014/3 |
Large cell carcinoma with rhabdoid phenotype |
|
|
8015/3 |
Glassy cell carcinoma |
CARCINOMA, UNDIFF., NOS |
802 |
8020/3 |
Carcinoma, undifferentiated type, NOS |
|
|
8021/3 |
Carcinoma, anaplastic type, NOS |
|
|
8022/3 |
Pleomorphic carcinoma |
GIANT & SPINDLE CELL CARCINOMA |
803 |
8030/3 |
Giant cell and spindle cell carcinoma |
|
|
8031/3 |
Giant cell carcinoma |
|
|
8032/3 |
Spindle cell carcinoma |
|
|
8033/3 |
Pseudosarcomatous carcinoma |
|
|
8034/3 |
Polygonal cell carcinoma |
|
|
8035/3 |
Carcinoma with osteoclast-like giant cells |
SMALL CELL CARCINOMA, NOS |
804 |
8041/3 |
Small cell carcinoma, NOS |
|
|
8043/3 |
Small cell carcinoma, fusiform cell |
|
|
|
|
PAPILLARY CARCINOMA, NOS |
805 |
8050/2 |
Papillary carcinoma in situ |
|
|
8050/3 |
Papillary carcinoma, NOS |
|
|
8051/3 |
Verrucous carcinoma, NOS |
|
|
8052/2 |
Papillary squamous cell carcinoma, non-invasive |
|
|
8052/3 |
Papillary squamous cell carcinoma |
SQUAMOUS CELL CARCINOMA, NOS |
807 |
8070/2 |
Squamous cell carcinoma in situ, NOS |
|
|
8070/3 |
Squamous cell carcinoma, NOS |
|
|
8071/3 |
Sq. cell carcinoma, keratinizing, NOS |
|
|
8072/3 |
Sq. cell carcinoma, lg. cell, non-ker. |
|
|
8073/3 |
Sq. cell carcinoma, sm. cell, non-ker. |
|
|
8074/3 |
Sq. cell carcinoma, spindle cell |
|
|
8075/3 |
Squamous cell carcinoma, adenoid |
|
|
8076/2 |
Sq. cell carc. in situ with question. stromal invas. |
|
|
8076/3 |
Sq. cell carcinoma, micro-invasive |
|
|
8078/3 |
Squamous cell carcinoma with horn formation |
TRANSITIONAL CELL CARCINOMA, NOS |
812 |
8120/2 |
Transitional cell carcinoma in situ |
|
|
8120/3 |
Transitional cell carcinoma, NOS |
|
|
8121/3 |
Schneiderian carcinoma |
|
|
8122/3 |
Trans. cell carcinoma, spindle cell |
|
|
8123/3 |
Basaloid carcinoma |
|
|
8124/3 |
Cloacogenic carcinoma |
ADENOCARCINOMA, NOS |
814 |
8140/2 |
Adenocarcinoma in situ |
|
|
8140/3 |
Adenocarcinoma, NOS |
|
|
8141/3 |
Scirrhous adenocarcinoma |
|
|
|
|
ADENOCARCINOMA, NOS (cont’d) |
814 |
8143/3 |
Superficial spreading adenocarcinoma |
|
|
8145/3 |
Carcinoma, diffuse type |
|
|
8147/3 |
Basal cell adenocarcinoma |
ADENOCA. IN ADENOMA. POLYP |
821 |
8210/2 |
Adenocarcinoma in situ in adenomatous polyp |
|
|
8210/3 |
Adenocarcinoma in adenomatous polyp |
|
|
8211/3 |
Tubular adenocarcinoma |
ADENOCA IN FAMIL POLYP COLI |
822 |
8220/2 |
Adenocarcinoma in situ in familial polyp. coli |
|
|
8220/3 |
Adenocarcinoma in adenoma. polyposis coli |
|
|
8221/2 |
Adenocarc. in situ in mult. adenomatous polyps |
|
|
8221/3 |
Adenocarcinoma in mult. adenomatous polyps |
SOLID CARCINOMA, NOS |
823 |
8230/2 |
Duct carcinoma in situ, solid type |
|
|
8230/3 |
Solid carcinoma, NOS |
|
|
8231/3 |
Carcinoma simplex |
CARCINOID TUMOR, MALIGNANT |
824 |
8240/3 |
Carcinoid tumor, malignant |
|
|
8241/3 |
Enterochromaffin cell carcinoid |
|
|
8242/3 |
Enterochromaffin-like cell tumor, malignant |
|
|
8243/3 |
Goblet cell carcinoid |
|
|
8244/3 |
Composite carcinoid |
|
|
8245/3 |
Adenocarcinoid tumor |
|
|
8246/3 |
Neuroendocrine carcinoma |
|
|
8249/3 |
Atypical carcinoid tumor |
BRONCHIOLO-ALVEOLAR ADENOCA. |
825 |
8255/3 |
Adenocarcinoma with mixed subtypes |
PAPILLARY ADENOCARCINOMA, NOS |
826 |
8260/3 |
Papillary adenocarcinoma, NOS |
|
|
8261/2 |
Adenocarcinoma in situ in villous adenoma |
|
|
8261/3 |
Adenocarcinoma in villous adenoma |
|
|
8262/3 |
Villous adenocarcinoma |
PAPILLARY ADENOCARCINOMA, NOS |
826 |
8263/2 |
Adenocarcinoma in situ in tubulovillous adenoma |
|
|
8263/3 |
Adenocarcinoma in tubulovillous adenoma |
MUCOEPIDERMOID CARCINOMA |
843 |
8430/3 |
Mucoepidermoid carcinoma |
CYSTADENOCARCINOMA, NOS |
844 |
8440/3 |
Cystadenocarcinoma, NOS |
MUCINOUS ADENOCARCINOMA |
848 |
8480/3 |
Mucinous adenocarcinoma |
|
|
8481/3 |
Mucin-producing adenocarcinoma |
SIGNET RING CELL CARCINOMA |
849 |
8490/3 |
Signet ring cell carcinoma |
MEDULLARY CARCINOMA, NOS |
851 |
8510/3 |
Medullary carcinoma, NOS |
ACINAR CELL CARCINOMA |
855 |
8550/3 |
Acinar cell carcinoma |
|
|
8551/3 |
Acinar cell cystadenocarcinoma |
ADENOSQUAMOUS CARCINOMA |
856 |
8560/3 |
Adenosquamous carcinoma |
|
|
8562/3 |
Epithelial-myoepithelial carcinoma |
ADENOCA. WITH METAPLASIA |
857 |
8570/3 |
Adenocarcinoma with squamous metaplasia |
|
|
8571/3 |
Adenocarcinoma w cartilag. & oss. metaplas. |
|
|
8572/3 |
Adenocarcinoma with spindle cell mataplasia |
|
|
8573/3 |
Adenocarcinoma with apocrine metaplasia |
|
|
8574/3 |
Adenocarcinoma with neuroendocrine differen. |
|
|
8575/3 |
Metaplastic carcinoma, NOS |
|
|
8576/3 |
Hepatoid adenocarcinoma |
NEVI & MELANOMAS |
872 |
8720/2 |
Melanoma in situ |
|
|
8720/3 |
Malignant melanoma, NOS |
|
|
8721/3 |
Nodular melanoma |
|
|
8722/3 |
Balloon cell melanoma |
|
|
8723/3 |
Malignant melanoma, regressing |
AMELANOTIC MELANOMA |
873 |
8730/3 |
Amelanotic melanoma |
|
|
|
|
MAL. MEL. IN JUNCT. NEVUS |
874 |
8743/3 |
Superficial spreading melanoma |
|
|
8745/3 |
Desmoplastic melanoma, malignant |
|
|
8746/3 |
Mucosal lentiginous melanoma |
MAL. MELAN. IN GIANT PIGMT. NEVUS |
876 |
8761/3 |
Mal. melanoma in giant pigmented nevus |
EPITHELIOID CELL MELANOMA |
877 |
8770/3 |
Mixed epithel. & spindle cell melanoma |
|
|
8771/3 |
Epithelioid cell melanoma |
|
|
8772/3 |
Spindle cell melanoma, NOS |
SARCOMA, NOS |
880 |
8800/3 |
Sarcoma, NOS |
|
|
8801/3 |
Spindle cell sarcoma |
|
|
8802/3 |
Giant cell sarcoma |
|
|
8803/3 |
Small cell sarcoma |
|
|
8804/3 |
Epithelioid sarcoma |
|
|
8805/3 |
Undifferentiated sarcoma |
|
|
8806/3 |
Desmoplastic small round cell tumor |
FIBROMATOUS NEOPLASMS |
881 |
8810/3 |
Fibrosarcoma, NOS |
|
|
8811/3 |
Fibromyxosarcoma |
|
|
8813/3 |
Fascial fibrosarcoma |
|
|
8814/3 |
Infantile fibrosarcoma |
|
|
8815/3 |
Solitary fibrous tumor, malignant |
LIPOSARCOMA NEOPLASMS |
885 |
8850/3 |
Liposarcoma, NOS |
|
|
8851/3 |
Liposarcoma, well differentiated |
|
|
8852/3 |
Myxoid liposarcoma |
|
|
8853/3 |
Round cell liposarcoma |
|
|
8854/3 |
Pleomorphic liposarcoma |
|
|
|
|
LIPOSARCOMA NEOPLASMS (cont’d) |
885 |
8855/3 |
Mixed type liposarcoma |
|
|
8857/3 |
Fibroblastic liposarcoma |
|
|
8858/3 |
Dedifferentiated liposarcoma |
MYOMATOUS NEOPLASMS |
889 |
8890/3 |
Leiomyosarcoma, NOS |
|
|
8891/3 |
Epithelioid leiomyosarcoma |
|
|
8894/3 |
Angiomyosarcoma |
|
|
8895/3 |
Myosarcoma |
|
|
8896/3 |
Myxoid leiomyosarcoma |
STROMAL SARCOMA |
893 |
8934/3 |
Carcinofibroma |
|
|
8935/3 |
Stromal sarcoma, NOS |
|
|
8936/3 |
Gastrointestinal stromal sarcoma |
CARCINOSARCOMA, NOS |
898 |
8980/3 |
Carcinosarcoma, NOS |
|
|
8981/3 |
Carcinosarcoma, embryonal type |
|
|
8982/3 |
Malignant myoepithelioma |
MALIGNANT LYMPHOMA, NOS |
959 |
9590/3 |
Malignant lymphoma, NOS |
|
|
9591/3 |
Malignant lymphoma, non-Hodgkin |
|
|
9596/3 |
Composite Hodgkin and non-Hodgkin lymphoma |
HODGKIN LYMPHOMA |
965 |
9650/3 |
Hodgkin lymphoma, NOS |
|
|
9651/3 |
Hodgkin lymphoma, lymphocyte-rich |
|
|
9652/3 |
Hodgkin lymphoma, mixed cellularity, NOS |
|
|
9653/3 |
Hodgkin lymphoma, lymphocytic deplet., NOS |
|
|
9654/3 |
Hodgkin lymphoma, lymphocytic deplet., diffuse fibrosis |
|
|
9655/3 |
Hodgkin lymphoma, lymphocyt. deplet., reticular |
|
|
9659/3 |
Hodgkin lymph., nodular lymphocyte predom. |
|
|
|
|
HODGKIN LYMPHOMA, NOD. SCLER. |
966 |
9661/3 |
Hodgkin granuloma [obs] |
|
|
9662/3 |
Hodgkin sarcoma [obs] |
|
|
9663/3 |
Hodgkin lymphoma, nodular sclerosis, NOS |
|
|
9664/3 |
Hodgkin lymphoma, nod. scler., cellular phase |
|
|
9665/3 |
Hodgkin lymphoma, nod. scler., grade 1 |
|
|
9667/3 |
Hodgkin lymphoma, nod. scler., grade 2 |
ML, SMALL B-CELL LYMPHOCYTIC |
967 |
9670/3 |
ML, small B lymphocytic, NOS |
|
|
9671/3 |
ML, lymphoplasmacytic |
|
|
9673/3 |
Mantle cell lymphoma |
|
|
9675/3 |
ML, mixed sm. and lg. cell, diffuse |
ML, LARGE B-CELL, DIFFUSE |
968 |
9680/3 |
ML, large B-cell, diffuse |
|
|
9684/3 |
ML, large B-cell, diffuse, immunoblastic, NOS |
|
|
9687/3 |
Burkitt lymphoma, NOS |
|
|
9688/3 |
T-cell histiocyte rich large B-cell lymphoma |
FOLLIC. & MARGINAL LYMPH, NOS |
969 |
9690/3 |
Follicular lymphoma, NOS |
|
|
9691/3 |
Follicular lymphoma, grade 2 |
|
|
9695/3 |
Follicular lymphoma, grade 1 |
|
|
9698/3 |
Follicular lymphoma, grade 3 |
|
|
9699/3 |
Marginal zone B-cell lymphoma, NOS |
T-CELL LYMPHOMAS |
970 |
9701/3 |
Sezary syndrome |
|
|
9702/3 |
Mature T-cell lymphoma, NOS |
|
|
9705/3 |
Angioimmunoblastic T-cell lymphoma |
OTHER SPEC. NON-HODGKIN LYMPHOMA |
971 |
9712/3 |
Intravascular large B-cell lymphoma |
|
|
9714/3 |
Anaplastic large cell lymphoma, T-cell and Null cell type |
|
|
9717/3 |
Intestinal T-cell lymphoma |
OTHER SPEC. NON-HODGKIN LYMPHOMA |
971 |
9719/3 |
NK/T-cell lymphoma, nasal and nasal-type |
PRECURS. CELL LYMPHOBLASTIC LYMPH. |
972 |
9724/3 |
SystemicEBV pos. T-cell lymphoproliferative disease of childhood |
|
|
9727/3 |
Precursor cell lymphoblastic lymphoma, NOS |
|
|
9728/3 |
Precursor B-cell lymphoblastic lymphoma |
|
|
9729/3 |
Precursor T-cell lymphoblastic lymphoma |
PLASMA CELL TUMORS |
973 |
9731/3 |
Plasmacytoma, NOS |
|
|
9734/3 |
Plasmacytoma, extramedullary |
|
|
9735/3 |
Plasmablastic lymphoma |
|
|
9737/3 |
ALK positive large B-cell lymphoma |
|
|
9738/3 |
Lrg B-cell lymphoma in HHV8-assoc. multicentric Castleman DZ |
MAST CELL TUMORS |
974 |
9740/3 |
Mast cell sarcoma |
|
|
9741/3 |
Malignant mastocytosis |
NEOPLASMS OF HISTIOCYTES AND ACCESSORY LYMPHOID CELLS |
975 |
9750/3 |
Malignant histiocytosis |
|
|
9751/3 |
Langerhans cell histiocytosis, NOS |
|
|
9754/3 |
Langerhans cell histiocytosis, disseminated |
|
|
9755/3 |
Histiocytic sarcoma |
|
|
9756/3 |
Langerhans cell sarcoma |
NEOPLASMS OF HISTIOCYTES AND ACCESSORY LYMPHOID CELLS (cont’d) |
|
9757/3 |
Interdigitating dendritic cell sarcoma |
|
|
9758/3 |
Follicular dendritic cell sarcoma |
|
|
9759/3 |
Fibroblastic reticular cell tumor |
PRECURSOR LYMPHOID NEOPLASMS |
981 |
9811/3 |
B lymphoblastic leukemia/lymphoma, NOS |
|
|
9812/3 |
Leukemia/lymphoma with t(9;22)(q34;q11.2);BCR-ABL1 |
|
|
9813/3 |
Leukemia/lymphoma with t(v;11q23);MLL rearranged |
PRECURSOR LYMPHOID NEOPLASMS |
981 |
9814/3 |
Leukemia/lymphoma with t(12;21)(p13;q22);TEL-AML1(ETV6-RUNX1) |
|
|
9815/3 |
B lymphoblastic leukemia/lymphoma with hyperdiploidy |
|
|
9816/3 |
Leukemia/lymphoma with hypodiploidy (hypodiploid ALL) |
|
|
9817/3 |
B lymphblastic leukemia/lymphoma with t(5;14)(q31;q32);IL3-IGH |
|
|
9818/3 |
Leukemia/lymphoma with t(1;19)(q23;p13.3); E2A PBX1 (TCF3 PBX1) |
PROLYMPH/PRECURS LEUKEMIA |
983 |
9831/3 |
T-cell large granular lymphocytic leukemia |
|
|
9837/3 |
T lymphoblastic leukemia/lymphoma |
CHRONIC MYELOPROLIFERATIVE DIS. |
996 |
9965/3 |
Myeloid and lymphoid neoplasms with PDGFRB rearrangement |
|
|
9967/3 |
Myeloid and lymphoid neoplasm with FGFR1 abnormalities |
MYELOPLASTIC/MYELOPROLIF. NEOPLASMS |
997 |
9971/3 |
Polymorphic PTLD |
|
|
9975/3 |
Myelodysplastic/Myeloproliferative neoplasm, unclassifiable |
CCDE Item 11.05: Registry primary site
Primary site [NAACCR data item #400] obtained from the central cancer registry database. See the SEER Program Coding and Staging Manual at http://seer.cancer.gov.
C000 = External upper lip
C001 = External lower lip
C002 = External lip, NOS
C003 = Mucosa of upper lip
C004 = Mucosa of lower lip
C005 = Mucosa of lip, NOS
C006 = Commissure of lip
C008 = Overlapping lesion of lip
C009 = Lip, NOS
C019 = Base of tongue, NOS
C020 = Dorsal surface of tongue, NOS
C021 = Border of tongue
C022 = Ventral surface of tongue, NOS
C023 = Anterior 2/3 of tongue, NOS
C024 = Lingual tonsil
C028 = Overlapping lesion of tongue
C029 = Tongue, NOS
C030 = Upper gum
C031 = Lower gum
C039 = Gum, NOS
C040 = Anterior floor of mouth
C041 = Lateral floor of mouth
C048 = Overlapping of floor of mouth
C049 = Floor of mouth, NOS
C050 = Hard palate
C051 = Soft palate, NOS
C052 = Uvula
C058 = Overlapping lesion of palate
C059 = Palate, NOS
C060 = Cheek mucosa
C061 = Vestibule of mouth
C062 = Retromolar area
C068 = Overlapping of other mouth
C069 = Mouth, NOS
C079 = Parotid gland
C080 = Submandibular gland
C081 = Sublingual gland
C088 = Overlapping maj salivary glands
C089 = Major salivary gland, NOS
C090 = Tonsillar fossa
C091 = Tonsillar pillar
C098 = Overlapping lesion of tonsil
C099 = Tonsil, NOS
C100 = Vallecula
C101 = Anterior surface of epiglottis
C102 = Lateral wall of oropharynx
C103 = Posterior wall of oropharynx
C104 = Branchial cleft
C108 = Overlapping of oropharynx
C109 = Oropharynx, NOS
C110 = Superior wall of nasopharynx
C111 = Posterior wall of nasopharynx
C112 = Lateral wall of nasopharynx
C113 = Anterior wall of nasopharynx
C118 = Overlapping of nasopharynx
C119 = Nasopharynx, NOS
C129 = Pyriform sinus
C130 = Postcricoid region
C131 = Aryepiglottic fold, hypophar.
C132 = Posterior wall of hypopharynx
C138 = Overlapping of hypopharynx
C139 = Hypopharynx, NOS
C140 = Pharynx, NOS
C142 = Waldeyer's ring
C148 = Overlap of pharynx, etc.
C150 = Cervical esophagus
C151 = Thoracic esophagus
C152 = Abdominal esophagus
C153 = Upper third of esophagus
C154 = Middle third of esophagus
C155 = Lower third of esophagus
C158 = Overlapping lesion of esophagus
C159 = Esophagus, NOS
C160 = Cardia, NOS
C161 = Fundus of stomach
C162 = Body of stomach
C163 = Gastric antrum
C164 = Pylorus
C165 = Lesser curvature stomach NOS
C166 = Greater curvature stomach NOS
C168 = Overlapping lesion of stomach
C169 = Stomach, NOS
C170 = Duodenum
C171 = Jejunum
C172 = Ileum
C173 = Meckel's diverticulum
C178 = Overlapping of small intestine
C179 = Small intestine, NOS
C180 = Cecum
C181 = Appendix
C182 = Ascending colon
C183 = Hepatic flexure of colon
C184 = Transverse colon
C185 = Splenic flexure of colon
C186 = Descending colon
C187 = Sigmoid colon
C188 = Overlapping of colon
C189 = Colon, NOS
C199 = Rectosigmoid junction
C209 = Rectum, NOS
C210 = Anus, NOS
C211 = Anal canal
C212 = Cloacogenic zone
C218 = Overlap of rectum, anus, etc.
C220 = Liver
C221 = Intrahepatic bile duct
C239 = Gallbladder
C240 = Extrahepatic bile duct
C241 = Ampulla of Vater
C248 = Overlapping of biliary tract
C249 = Biliary tract, NOS
C250 = Head of pancreas
C251 = Body of pancreas
C252 = Tail of pancreas
C253 = Pancreatic duct
C254 = Islets of Langerhans
C257 = Other spec pancreas
C258 = Overlapping of pancreas
C259 = Pancreas, NOS
C260 = Intestinal tract, NOS
C268 = Overlapping of digestive system
C269 = Gastrointestinal tract, NOS
C300 = Nasal cavity
C301 = Middle ear
C310 = Maxillary sinus
C311 = Ethmoid sinus
C312 = Frontal sinus
C313 = Sphenoid sinus
C318 = Overlap of accessory sinuses
C319 = Accessory sinus, NOS
C320 = Glottis
C321 = Supraglottis
C322 = Subglottis
C323 = Laryngeal cartilage
C328 = Overlapping of larynx
C329 = Larynx, NOS
C339 = Trachea
C340 = Main bronchus
C341 = Upper lobe, lung
C342 = Middle lobe, lung
C343 = Lower lobe, lung
C348 = Overlapping of lung
C349 = Lung, NOS
C379 = Thymus
C380 = Heart
C381 = Anterior mediastinum
C382 = Posterior mediastinum
C383 = Mediastinum, NOS
C384 = Pleura, NOS
C388 = Ovr. heart, mediastinum, pleura
C390 = Upper respiratory tract, NOS
C398 = Overlap of respiratory system
C399 = Ill-defined sites of resp sys
C400 = Long bones: upper limb, scapula
C401 = Short bones: upper limb
C402 = Long bones: lower limb
C403 = Short bones: lower limb
C408 = Overlap of bones, etc. of limbs
C409 = Bone of limb, NOS
C410 = Bones of skull and face
C411 = Mandible
C412 = Vertebral column
C413 = Rib, Sternum, Clavicle
C414 = Pelvic bones, Sacrum, Coccyx
C418 = Overlap bones, etc.
C419 = Bone, NOS
C420 = Blood
C421 = Bone marrow
C422 = Spleen
C423 = Reticuloendothelial system, NOS
C424 = Hematopoietic system, NOS
C440 = Skin of lip, NOS
C441 = Eyelid
C442 = External ear
C443 = Skin other/unspec parts of face
C444 = Skin of scalp and neck
C445 = Skin of trunk
C446 = Skin of upper limb and shoulder
C447 = Skin of lower limb and hip
C448 = Overlapping of skin
C449 = Skin, NOS
C470 = Periph nerves: head, face, neck
C471 = Peri nerves: upr limb, shoulder
C472 = Periph nerves: lower limb, hip
C473 = Periph nerves: thorax
C474 = Periph nerves: abdomen
C475 = Periph nerves: pelvis
C476 = Periph nerves: trunk, NOS
C478 = Overlap of peripheral nerves
C479 = Autonomic nervous system, NOS
C480 = Retroperitoneum
C481 = Specified parts of peritoneum
C482 = Peritoneum, NOS
C488 = Overlap retroper & peritoneum
C490 = Conn tissues: head, face, neck
C491 = Conn tissues: upr limb, shoulder
C492 = Conn tissues: lower limb, hip
C493 = Conn tissues: thorax
C494 = Conn tissues: abdomen
C495 = Conn tissues: pelvis
C496 = Conn tissues: trunk, NOS
C498 = Overlapping conn tissues
C499 = Conn tissues, NOS
C500 = Nipple
C501 = Central portion of breast
C502 = Upper-inner quadrant of breast
C503 = Lower-inner quadrant of breast
C504 = Upper-outer quadrant of breast
C505 = Lower-outer quadrant of breast
C506 = Axillary tail of breast
C508 = Overlapping of breast
C509 = Breast, NOS
C510 = Labium majus
C511 = Labium minus
C512 = Clitoris
C518 = Overlapping of vulva
C519 = Vulva, NOS
C529 = Vagina, NOS
C530 = Endocervix
C531 = Exocervix
C538 = Overlapping of cervix uteri
C539 = Cervix uteri
C540 = Isthmus uteri
C541 = Endometrium
C542 = Myometrium
C543 = Fundus uteri
C548 = Overlapping of corpus uteri
C549 = Corpus uteri
C559 = Uterus, NOS
C569 = Ovary
C570 = Fallopian tube
C571 = Broad ligament
C572 = Round ligament
C573 = Parametrium
C574 = Uterine adnexa
C577 = Other spec fem genital organs
C578 = Overlap of fem genital organs
C579 = Female genital tract, NOS
C589 = Placenta
C600 = Prepuce
C601 = Glans penis
C602 = Body of penis
C608 = Overlapping of penis
C609 = Penis, NOS
C619 = Prostate gland
C620 = Undescended testis
C621 = Descended testis
C629 = Testis, NOS
C630 = Epididymis
C631 = Spermatic cord
C632 = Scrotum, NOS
C637 = Other spec male genital organs
C638 = Overlap male genital organs
C639 = Male genital organs, NOS
C649 = Kidney, NOS
C659 = Renal pelvis
C669 = Ureter
C670 = Trigone of bladder
C671 = Dome of bladder
C672 = Lateral wall of bladder
C673 = Anterior wall of bladder
C674 = Posterior wall of bladder
C675 = Bladder neck
C676 = Ureteric orifice
C677 = Urachus
C678 = Overlapping of bladder
C679 = Bladder, NOS
C680 = Urethra
C681 = Paraurethral gland
C688 = Overlapping of urinary organs
C689 = Urinary system, NOS
C690 = Conjunctiva
C691 = Cornea, NOS
C692 = Retina
C693 = Choroid
C694 = Ciliary body
C695 = Lacrimal gland
C696 = Orbit, NOS
C698 = Overlapping of eye and adnexa
C699 = Eye, NOS
C700 = Cerebral meninges
C701 = Spinal meninges
C709 = Meninges, NOS
C710 = Cerebrum
C711 = Frontal lobe
C712 = Temporal lobe
C713 = Parietal lobe
C714 = Occipital lobe
C715 = Ventricle, NOS
C716 = Cerebellum, NOS
C717 = Brain stem
C718 = Overlapping of brain
C719 = Brain, NOS
C720 = Spinal cord
C721 = Cauda equina
C722 = Olfactory nerve
C723 = Optic nerve
C724 = Acoustic nerve
C725 = Cranial nerve, NOS
C728 = Overlap of brain & CNS
C729 = Nervous system, NOS
C739 = Thyroid gland
C740 = Cortex of adrenal gland
C741 = Medulla of adrenal gland
C749 = Adrenal gland, NOS
C750 = Parathyroid gland
C751 = Pituitary gland
C752 = Craniopharyngeal duct
C753 = Pineal gland
C754 = Carotid body
C755 = Aortic body & other paraganglia
C758 = Overlapping of endocrine glands
C759 = Endocrine gland, NOS
C760 = Head, face or neck, NOS
C761 = Thorax, NOS
C762 = Abdomen, NOS
C763 = Pelvis, NOS
C764 = Upper limb, NOS
C765 = Lower limb, NOS
C767 = Other ill-defined sites
C768 = Overlap of ill-defined sites
C770 = Lymph nodes: head, face & neck
C771 = Intrathoracic lymph nodes
C772 = Intra-abdominal lymph nodes
C773 = Lymph nodes of axilla or arm
C774 = Lymph nodes:inguinal region or leg
C775 = Pelvic lymph nodes
C778 = Lymph nodes of multiple regions
C779 = Lymph node, NOS
C809 = Unknown primary site
CCDE Item 11.06: Registry CS-derived SS2000
Collaborative stage (CS)-derived summary stage 2001 [NAACCR data item #3020] obtained from the central cancer registry database. See CS Staging Manual at http://www.cancerstaging.org and the SEER Summary Staging Manual at http://seer.cancer.gov .
Value |
Description |
0 |
In situ |
1 |
Localized |
2 |
Regional, direct extension |
3 |
Regional, lymph nodes only |
4 |
Regional, extension and nodes |
5 |
Regional, NOS |
7 |
Distant |
8 |
Not applicable |
9 |
Unknown/unstaged |
CCDE Item 11.07: Registry CS-derived AJCC stage group
Collaborative stage (CS)-derived AJCC stage [NAACCR data item #3000] obtained from the central cancer registry database WHEN AVAILABLE.
Value |
Description |
Value |
Description |
Value |
Description |
000 |
Stage 0 |
322 |
Stage IIA1 |
590 |
Stage IIISB (lymphoma only) |
010 |
Stage 0a |
323 |
Stage IIA2 |
600 |
Stage IIIS (lymphoma only) |
020 |
Stage 0is |
330 |
Stage IIB |
610 |
Stage IIIESA (lymphoma only) |
100 |
Stage I |
340 |
Stage IIC |
620 |
Stage IIIESB (lymphoma only) |
110 |
Stage I NOS |
350 |
Stage IIEA (lymphoma only) |
630 |
Stage IIIES (lymphoma only) |
120 |
Stage IA |
360 |
Stage IIEB (lymphoma only) |
700 |
Stage IV |
121 |
Stage IA NOS |
370 |
Stage IIE (lymphoma only) |
710 |
Stage IV NOS |
130 |
Stage IA1 |
380 |
Stage IISA (lymphoma only) |
720 |
Stage IVA |
140 |
Stage IA2 |
390 |
Stage IISB (lymphoma only) |
721 |
Stage IVA1 |
150 |
Stage IB |
400 |
Stage IIS (lymphoma only) |
722 |
Stage IVA2 |
151 |
Stage IB NOS |
410 |
Stage IIESA (lymphoma only) |
730 |
Stage IVB |
160 |
Stage IB1 |
420 |
Stage IIESB (lymphoma only) |
740 |
Stage IVC |
170 |
Stage IB2 |
430 |
Stage IIES (lymphoma only) |
888 |
Not applicable |
180 |
Stage IC |
500 |
Stage III |
900 |
Stage Occult |
190 |
Stage IS |
510 |
Stage III NOS |
999 |
Stage Unknown |
230 |
Stage ISA (lymphoma only) |
520 |
Stage IIIA |
|
|
240 |
Stage ISB (lymphoma only) |
530 |
Stage IIIB |
|
|
200 |
Stage IEA (lymphoma only) |
540 |
Stage IIIC |
|
|
210 |
Stage IEB (lymphoma only) |
541 |
Stage IIIC1 |
|
|
220 |
Stage IE (lymphoma only) |
542 |
Stage IIIC2 |
|
|
300 |
Stage II |
550 |
Stage IIIEA (lymphoma only) |
|
|
310 |
Stage II NOS |
560 |
Stage IIIEB (lymphoma only) |
|
|
320 |
Stage IIA |
570 |
Stage IIIE (lymphoma only) |
|
|
CCDE Item 11.08: Registry CS extension
Collaborative stage (CS) extension [NAACCR data item #2810] obtained from the central cancer registry database. See CS Staging Manual at http://www.cancerstaging.org.
Value |
Description for Colon |
Description for Rectum |
TNM 7 |
TNM 6 |
SS77 |
SS2000 |
000 |
In situ; noninvasive; intraepithelial |
In situ; noninvasive; intraepithelial |
Tis |
Tis |
IS |
IS |
050 |
(Adeno)carcinoma in a polyp or adenoma, noninvasive |
(Adeno)carcinoma in a polyp or adenoma, noninvasive |
Tis |
Tis |
IS |
IS |
100 |
Invasive tumor confined to mucosa, NOS, including intramucosal, NOS |
Invasive tumor confined to mucosa, NOS, including intramucosal, NOS |
Tis |
Tis |
L |
L |
110 |
Lamina propria, including lamina propria in the stalk of a polyp |
Lamina propria, including lamina propria in the stalk of a polyp |
Tis |
Tis |
L |
L |
120 |
Confined to and not through the muscularis mucosae, including muscularis mucosae in the stalk of a polyp |
Confined to and not through the muscularis mucosae, including muscularis mucosae in the stalk of a polyp |
Tis |
Tis |
L |
L |
130 |
Confined to head of polyp, NOS |
Confined to head of polyp, NOS |
T1 |
T1 |
L |
L |
140 |
Confined to stalk of polyp, NOS |
Confined to stalk of polyp, NOS |
T1 |
T1 |
L |
L |
150 |
Invasive tumor in polyp, NOS |
Invasive tumor in polyp, NOS |
T1 |
T1 |
L |
L |
160 |
Invades submucosa (superficial invasion), including submucosa in the stalk of a polyp |
Submucosa (superficial invasion), including submucosa in the stalk of a polyp |
T1 |
T1 |
L |
L |
170 |
Stated as T1[NOS] with no other information on extension |
Stated as T1[NOS] with no other information on extension |
T1 |
T1 |
L |
L |
200 |
Muscularis propria invaded Stated as T2[NOS] with no other information on extension |
Muscularis propria invaded Stated as T2[NOS] with no other information on extenision |
T2 |
T2 |
L |
L |
300 |
Localized, NOS Confined to colon, NOS |
Localized, NOS Confined to rectum, NOS |
T1
|
T1
|
L |
L |
400 |
Extension through wall, NOS Invasion through muscularis propria or muscularis, NOS Non-peritonealized pericolic tissues invaded Perimuscular tissue invaded Subserosal tissue/(sub)serosal fat invaded Transmural, NOS |
Extension through wall, NOS Invasion through muscularis propria or muscularis, NOS Perimuscular tissue invaded Subserosal tissue/(sub)serosal fat invaded Non-peritonealized pericolic tissues invaded Transmural, NOS |
T3 |
T3 |
L |
L |
410 |
Stated as T2[NOS] with no other information on extension |
Stated as T2[NOS] with no other information on extension |
T3 |
T3 |
L |
L |
420 |
Fat, NOS |
Fat, NOS |
T3 |
T3 |
RE |
RE |
450 |
Extension to: All colon sites: Adjacent tissue(s), NOS Connective tissue Mesenteric fat Mesentery Mesocolon Pericolic fat Ascending and descending colon Retroperitoneal fat Transverse colon/flexures Gastrocolic ligament Greater omentum |
Adjacent (connective) tissue: For all sites: Perirectal fat For rectosigmoid: Mesentery (including mesenteric fat, mesocolon) Pericolic fat For rectum: Extension to anus Rectovaginal septum
|
T3 |
T3 |
RE |
RE |
460 |
Adherent to other organs or structures, but no microscopic tumor found in adhesion(s) |
Adherent to other organs or structures but no tumor found in adhesion(s) |
T3 |
T3 |
RE |
RE |
490 |
|
Stated as T4[NOS] with no other information on extension |
T4NOS |
T4 |
RE |
RE |
500 |
Invasion of/through serosa (mesothelium) (visceral peritoneum) |
Invasion of/through serosa (mesothelium) (visceral peritoneum) |
T4a |
T4 |
RE |
RE |
550 |
Any of [(420) to (450)] + (500) |
(500) with [(420) or (450)] |
T4a |
T4 |
RE |
RE |
560 |
Stated as T4a with no other information on extension |
Stated as T4a with no other information on extension |
T4a |
T4 |
RE |
RE |
570 |
Adherent to other organs or structures, NOS |
Adherent to other organs or structures, NOS |
T4b |
T4 |
RE |
RE |
600 |
All colon sites: Small intestine Cecum and appendix: Greater omentum Ascending colon: Greater omentum Liver, right lobe Transverse colon and flexures: Gallbladder/bile ducts Kidney Liver Pancreas Spleen Stomach Descending colon: Greater omentum Pelvic wall Spleen Sigmoid colon: Greater omentum Pelvic wall |
Rectosigmoid: Cul de sac (rectouterine pouch) Pelvic wall Small intestine Rectum: Bladder for males only Cul de sac (rectouterine pouch) Ductus deferens Pelvic wall Prostate Rectovesical fascia for male only Seminal vesicle(s) Skeletal muscle of pelvic floor Vagina |
T4b |
T4 |
RE |
RE |
650 |
All colon sites: Abdominal wall Retroperitoneum (excluding fat) |
|
T4b |
T4 |
RE |
RE |
660 |
Ascending colon: Right kidney Right ureter Descending colon: Left kidney Left ureter |
|
T4b |
T4 |
RE |
RE |
700 |
Cecum, ascending, descending and sigmoid colon: Fallopian tube Ovary Uterus |
Rectosigmoid: Bladder Colon via serosa Fallopian tube(s) Ovary(ies) Prostate Ureter(s) Uterus Rectum: Bladder for female only Bone(s) of pelvis Urethra Uterus |
T4b |
T4 |
D |
D |
750 |
All colon sites unless otherwise stated above: Adrenal (suprarenal) gland Bladder Diaphragm Fistula to skin Gallbladder Other segment(s) of colon via serosa |
|
T4b |
T4 |
D |
D |
800 |
Further contiguous extension: Cecum and appendix: Kidney Liver Ureter Transverse colon and flexures: Ureter Sigmoid colon: Cul de sac (rectouterine pouch) Ureter Other contiguous extension |
Further contiguous extension |
T4b |
T4 |
D |
D |
850 |
Stated as T4b with no other information on extension |
Stated as T4b with no other information on extension |
T4b |
T4 |
RE |
RE |
900 |
Stated as T4[NOS] with no other information on extension |
Stated as T4[NOS] with no other information on extension |
T4NOS |
T4 |
RE |
RE |
950 |
No evidence of primary tumor |
No evidence of primary tumor |
T0 |
T0 |
U |
U |
999 |
Unknown extension Primary tumor cannot be assessed Not documented in patient record |
Unknown extension Primary tumor cannot be assessed Not documented in patient record |
TX |
TX |
U |
U |
CCDE Item 11.09: Registry CS lymph nodes
Collaborative stage (CS) lymph nodes [NAACCR data item #2830] obtained from the central cancer registry database. See CS Staging Manual at http://www.cancerstaging.org.
Value |
Description for Colon |
Description for Rectum |
TNM 7 |
TNM 6 |
SS77 |
SS2000 |
000 |
None; no regional lymph node involvement |
None; no regional lymph node involvement |
N0 |
N0 |
None |
None |
050 |
Tumor deposit(s) in the subserosa, or non-peritonealized pericolic or perirectal tissues without regional nodal metastasis |
Tumor deposit(s) in the subserosa, or non-peritonealized pericolic or perirectal tissues without regional nodal metastasis |
N1c |
N1 |
RN |
RN |
100 |
Regional lymph node(s) for all colon sites: Colic (NOS) Epicolic (adjacent to bowel wall) Mesocolic (NOS) Paracolic/pericolic |
Regional lymph node(s): Rectosigmoid: Paracolic/pericolic Perirectal Rectal Nodule(s) or foci in pericolic fat/adjacent mesentery/mesocolic fat Rectum: Perirectal Rectal, NOS Nodule(s) or foci in perirectal fat |
^ |
* |
RN |
RN |
200 |
Regional lymph node(s), for specific subsites: Cecum: Cecal: anterior (prececal), posterior (retrocecal); NOS Ileocolic Right colic Ascending colon: Ileocolic Middle colic Right colic Transverse colon and flexures: Inferior mesenteric for splenic flexure only Left colic for splenic flexure only Middle colic Right colic for hepatic flexure only Descending colon: Inferior mesenteric Left colic Sigmoid Sigmoid colon: Inferior mesenteric Sigmoidal (sigmoid mesenteric) Superior hemorrhoidal Superior rectal |
Regional lymph node(s): Rectosigmoid: Colic, NOS Left colic Hemorrhoidal, superior or middle Inferior mesenteric Middle rectal Sigmoidal (sigmoid mesenteric) Superior rectal Rectum: Hemorrhoidal, superior, middle or inferior Inferior mesenteric Internal iliac (hypogastric) Obturator Rectal, superior, middle, or inferior Sacral, NOS Lateral (laterosacral) Middle (promontorial) (Gerota's node) Presacral Sacral promotory Sigmoidal (sigmoid mesenteric) |
^ |
* |
RN |
RN |
300 |
Regional lymph node(s) for all colon sites: Mesenteric, NOS Regional lymph node(s), NOS |
Mesenteric, NOS Regional lymph node(s), NOS |
^ |
* |
RN |
RN |
400 |
Stated as N1 pathologic |
Stated as N1 pathologic |
N1NOS |
N1 |
RN |
RN |
410 |
Stated as N1a pathologic |
Stated as N1a pathologic |
N1a |
N1 |
RN |
RN |
420 |
Stated as N1b pathologic |
Stated as N1b pathologic |
N1b |
N1 |
RN |
RN |
450 |
Stated as N2 pathologic |
Stated as N2 pathologic |
N2NOS |
N2 |
RN |
RN |
460 |
Stated as N2a pathologic |
Stated as N2a pathologic |
N2a |
N2 |
RN |
RN |
470 |
Stated as N2b pathologic |
Stated as N2b pathologic |
N2b |
N2 |
RN |
RN |
800 |
Lymph nodes, NOS |
Lymph nodes, NOS |
^ |
* |
RN |
RN |
999 |
Unknown; not stated Regional lymph node(s) cannot be assessed Not documented in patient record |
Unknown; not stated Regional lymph node(s) cannot be assessed Not documented in patient record |
NX |
NX |
U |
U |
^ and * For codes 100-300 and 800 ONLY, please see collaborative stage manual for specific coding instructions.
CCDE Item 11.10: Registry CS mets at diagnosis
Collaborative stage (CS) metastases (mets) at diagnosis obtained from the central cancer registry database. North American Association of Central Cancer Registries (NAACCR) data item #2850. See the CS Staging Manual at http://www.cancerstaging.org .
Value |
Description for Colon |
Description for Rectum |
TNM 7 |
TNM 6 |
SS77 |
SS2000 |
00 |
No; none |
No; none |
M0 |
M0 |
None |
None |
05 |
|
Metastasis to a single distant lymph node chain, NOS |
Ma1 |
M1 |
D |
D |
08 |
Cecum, ascending, hepatic flexure and transverse colon: Superior mesenteric lymph node(s) only |
|
M1a |
M1 |
RN |
D |
15 |
Metastasis to a single distant lymph node chain other than code 08 For all colon sites : Common iliac Distant lymph node(s), NOS External iliac Para-aortic Retroperitoneal For cecum, ascending colon, transverse colon, and hepatic flexure : Inferior mesenteric For splenic flexure, descending colon, and sigmoid colon : Superior mesenteric |
Metastasis to a single distant lymph node chain Rectosigmoid : Internal iliac (hypogastric) Obturator |
M1a |
M1 |
D |
D |
20 |
Metastasis to a single distant organ |
Metastasis to other single distant lymph node chains, including external iliac or common iliac |
M1a |
M1 |
D |
D |
22 |
Stated as M1a with no other information on distant metastases |
|
M1a |
M1 |
D |
D |
25 |
Metastasis to more than one distant lymph node chain other than code 08 For all colon sites : Common iliac Distant lymph node(s), NOS External iliac Para-aortic Retroperitoneal For cecum, ascending colon, transverse colon, and hepatic flexure : Inferior mesenteric Superior mesenteric For splenic flexure, descending colon, and sigmoid colon : Superior mesenteric |
Metastasis to a single distant organ |
M1b |
M1 |
D |
D |
27 |
|
Stated as M1a, NOS |
M1a |
M1 |
D |
D |
30 |
Metastases to more than one distant organ Metastases to the peritoneum Carcinomatosis |
Metastasis to more than one distant lymph node chain |
M1b |
M1 |
D |
D |
35 |
(08 or 15 or 25) PLUS 20 or 30) Distant lymph nodes plus other distant metastases |
Distant metastases to more than one distant organ Metastases to the peritoneum Carcinomatosis Stated as M1b, NOS |
M1b |
M1 |
D |
D |
38 |
Stated as M1b with no other information on distant metastases |
|
M1b |
M1 |
D |
D |
45 |
|
(05 or 15 or 20) plus (25 or 35) Distant lymph node(s) plus other distant metastases |
M1b |
M1 |
D |
D |
60 |
Distant metastasis, NOS Stated as M1[NOS] with no other information on distant metastases |
Distant metastasis, NOS M1, NOS |
N1NOS |
M1 |
D |
D |
99 |
Unknown if distant metastasis Distant metastasis cannot be assessed Not documented in patient record |
Unknown if distant metastasis Distant metastasis cannot be assessed Not documented in patient record |
M0 |
MX |
U |
U |
The following values for Colon are obsolete. They have been excluded from this table but will be considered valid responses if reported: 10, 40 and 50.
The following values for Rectum are obsolete. They have been excluded from this table, but will be considered valid responses if reported: 10, 11, 12, 40 and 50
CHAPTER 4
References
CCDE Submission
Narrative Guidelines
CCDE Submission Narrative Guidelines
January 1, 2010
The submission narrative provides a structured way for grantees to respond to questions or issues identified during the CCDE data review.
The submission narrative is comprised of two sections:
The first section should include written responses to any action items that were identified in the previous data submission. Following the review and discussion of the grantee’s CCDE data file by the CDC Program Consultant, CDC Scientific Consultant and IMS Clinical Data Technical Consultant and grantee staff, an Action Plan will be developed. The CDC Program Consultant will provide this information to the appropriate staff at the program. Each action item should be addressed by the grantee in this first section.
II. The second section should address the following questions. If the question is not applicable to your program at this time, please indicate “N/A”:
1. Summarize reasons for any significant data issues identified by the program but not resolved prior to submitting the CCDE file to the CDC.
2. Identify any modifications made to the software which generates the CCDE file that would cause significant changes in the distribution of the values for individual data items.
Identify any batch recoding of records in the CCDE file that would cause significant changes in the distribution of the values for individual data items.
Identify any data management staffing, system, or procedural changes that would affect the data management capacity. Examples of these include staff turnover, revision of data collection forms, revision of data entry screens, a change in the data collection model (i.e. centralized to decentralized), etc.
Identify any plans to significantly upgrade existing data management software, or to develop and migrate the client database to a new data management system.
SAMPLE
CCDE Submission Narrative for Your Program
September 2010 Submission
Part 1. Action Item Responses
Standard Quality Indicator Guide (SQIG)
Item 8: There are several records where
Status of Final Diagnosis = Complete, but the Final Diagnosis and
Date of Final Diagnosis are missing.
RESPONSE: We used
the CCDE Edit program to identify 20 records with incomplete data.
These records were reviewed and corrected.
Item 10: The CDC provides a recommendation
that at least 80% of clients should take less than 60 days from the
beginning of screening until final diagnosis. Your program does not
meet this recommendation. Please discuss causes for the delay
between screening and diagnosis.
RESPONSE: While
reviewing the cases we have discovered some reporting issues. At the
time of submission, we continue to evaluate all the causes for the
delay in timeliness. We will report on any findings as soon as
possible.
Part 2: Address the following questions:
Summarize reasons for any significant data issues identified by the program but not resolved prior to submitting the CCDE file to the CDC.
Please see response to SQIG Item 10.
Identify any modifications made to the software which generates the CCDE file that would cause significant changes in the distribution of the values for individual data items.
Not applicable.
Identify any batch recoding of records in the CCDE file that would cause significant changes in the distribution of the values for individual data items.
We modified how our export program creates the record ID. The record ID has been changed for all records reported in this submission.
Identify any data management staffing, system, or procedural changes that would affect the data management capacity.
Not applicable.
Identify any plans to significantly upgrade existing data management software, or to develop and migrate the client database to a new data management system.
Not applicable.
CDC RACE AND
ETHNICITY CODE SET
TABLE 1 – RACE CONCEPTS AND CODES
TABLE 2 – ETHNICITY CONCEPTS AND CODES
CCDE Category |
Concept |
Hispanic or Latino |
Spaniard |
|
Mexican |
|
Central American |
|
South American |
|
Latin American |
|
Puerto Rican |
|
Cuban |
|
Dominican |
|
|
Not Hispanic or Latino |
|
CCDE DATA DEFINITION TABLE
GLOSSARY OF TERMS
ACS: |
|
Adenomatous polyp |
See “Polyp”. More likely to develop into cancer than a non-adenomatous polyp. Also known as “adenoma”. |
CDC CRCCP Home Page: |
|
CO-RADS |
Colonoscopy Reporting and Data System (CO-RADS), a standardized colonoscopy reporting and data system. CO-RADS specifies the elements that should be included in all colonoscopy reports and presents a standard method for reporting them. |
Colonoscope: |
A flexible, lighted instrument with a built-in tiny camera used to view the inside of the entire colon and rectum. |
Colonoscopy: |
An examination in which the doctor looks at the internal walls of the entire colon through a flexible, lighted instrument called a colonoscope. The doctor may collect samples of tissue or cells for closer examination. The doctor may also remove polyps during colonoscopy. |
Colorectal: |
Related to the colon, rectum or both. |
CRCCP Resource Web Site: |
|
CS Coding Manual: |
|
Double-Contrast Barium Enema |
A series of x-rays of the colon and rectum. The x-rays are taken after the patient is given an enema, followed by an injection of air. The barium outlines the intestines on the x-rays, allowing many abnormal growths to be visible. |
Fecal Immunochemical Test (FIT) |
Like a fecal occult blood test (FOBT), an FIT also detects hidden blood in the stool using a different technique than guaiac based FOBT. FIT is effectively done the same way as an FOBT, but it may be more specific or more sensitive than a guaiac based FOBT. |
Fecal Occult Blood Test (FOBT) |
A guaiac based test to check for hidden blood in stool. Fecal refers to stool. Occult means hidden. Sometimes called "F.O.B.T.". |
Flexible Sigmoidoscopy |
A procedure in which the doctor looks inside the rectum and the lower portion of the colon (sigmoid colon) through a flexible, lighted tube called a sigmoidoscope. The doctor may collect samples of tissue or cells for closer examination and remove some polyps within view. |
Gastroenterologist |
A doctor who specializes in diagnosing and treating disorders of the digestive system (which includes the esophagus, stomach, pancreas, intestines, and liver). |
Polyp |
An abnormal, often precancerous growth of tissue (colorectal polyps are growths of tissue inside the intestine). |
Rectum |
The last 8 to 10 inches of the large intestine. The rectum stores solid waste until it leaves the body through the anus. |
Screening Test |
"Screening tests" are tests used to check, or screen, for disease when there are no symptoms. Screening tests for colorectal cancer include: fecal occult blood test, flexible sigmoidoscopy, colonoscopy, and double contrast barium enema. (When a test is performed to find out why symptoms exist, it is called a "diagnostic" test). |
SEER Coding Manual: |
|
Sigmoidoscope |
A flexible, lighted instrument with a built-in tiny camera that allows the doctor to view the lining of the rectum and lower portion of the colon. |
Stool DNA |
A stool DNA test looks for traces of DNA (genetic material) shed by polyps and/or colorectal tumors. |
Virtual Colonoscopy |
A screening examination of the colon in which x-rays obtained by CAT scan are used to generate computerized three-dimensional images of the colonic mucosa. |
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | ITEM NO / NAME: |
| Author | Mattingl |
| File Modified | 0000-00-00 |
| File Created | 2021-02-02 |
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