Notes for slide 2 Welcome to today s training webinar. We appreciate everyone taking time today to hear our presentations. We are very excited to fina
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2 Notes for slide 2 Welcome to today s training webinar. We appreciate everyone taking time today to hear our presentations. We are very excited to finally be able to put these genomics related data items into production. The training today is divided into three sections. First, we have two genetic counselors, one from Intermountain Healthcare and one from Huntsman Cancer Institute, who will give a Genetics for Dummies overview (see New mandatory data items: Genetics and BRCA for this presentation). Hopefully it will help you see the importance of this data and why we are starting to collect it. Sandie Edwards, a research associate for the Utah Cancer Registry, will briefly talk about the process of deciding which data items to collect and the testing process that has been ongoing for a few years. Finally, I will spend time discussing each data item, the coding structure and what information needs to be collected, recorded and transmitted to 2
3 UCR. 2
4 Notes for slide 3 Since the discovery of the BRCA1/2 genes, the awareness of cancer genetic risk and the importance of cancer genetic testing have steadily increased. Currently, Healthy People 2020 is attempting to improve the number of women (and men) who receive genetic screening and counseling for BRCA1/2 through its goal of improving health and preventing harm through valid and useful genomic tools in clinical and public health practices. Improvements to statewide surveillance are an imperative component to effectively addressing challenges to appropriate genetic testing, counseling, and referral. 3
5 4
6 Notes for slide 5 Utah Cancer Registry conducted a pilot surveillance project, addressing the ability of Utah Cancer Registry to determine for those with a diagnosis of cancer 1) whether the case met criteria for HBOC germline testing and 2) whether genetic counseling and/or testing occurred. Experienced Certified Tumor Registrars (CTR) abstracted risk, counseling, and testing variables from medical records. Pilot project abstracting was conducted between September 2015 and September
7 Notes for slide 6 For cancer cases who had testing, 75% of cases had BRCA testing within 6 months of diagnosis and 90% within one year of diagnosis. A few cancer cases had BRCA testing before diagnosis. Only 25% of cancer cases who had testing were tested within the first month. The pilot project data indicates that HBOC abstracting should be done around one year after diagnosis in order to achieve completeness. 6
8 Notes for slide 7 The new HBOC data items can be specified by three categories: referral, testing & testing results There is one data item each for referral and testing. 7
9 Notes for slide 8 There are four data items for the testing results BRCA 1 & BRCA 2 Results NOS Results for testing not specified as BRCA 1 or 2 Other Results for testing specific to genes other than BRCA 8
10 Notes for slide 9 Eligibility requirements for breast cases are as listed: Female breast age 60 and younger Male breast any age Both invasive & in situ breast cases are included 9
11 Notes for slide 10 Histologies that fit the criteria vary a little bit, depending on the behavior of the reported cancer. Refer to the table in the guidelines to be sure of the eligible histologies for each site. For invasive breast, all histologies are included EXCEPT those listed as EXCLUDED Excluded: Mesotheliomas, Kaposi s Sarcomas, Lymphomas/leukemias All other histologies are included for invasive breast cases In Situ breast - there is a specific list of included histologies, for both male & female breast cases. They are listed in the guidelines. We relied on the following information from our the standard setters to produce the list of included histologies for the in situ breast cases. Histologies specified in the new SEER Solid Tumor Rules for breast, 2018 ICD-0-3 list of updated histologies 2007 SEER MP/H rules 10
12 Notes for slide 11 Here are some examples of a few of the in situ histologies from the inclusion table that are not as common, but ones you might see. Included is the source or sources that identified the histology as specifically in situ (e.g. Breast Solid Tumor Rules or MP/H Rules). We tried to include any in situ histology that might be seen in cases that meet the criteria for inclusion. 11
13 Notes for slide 12 This slide includes more examples of histologies specific to in situ breast cases. 12
14 Notes for slide 13 This slide includes more examples of histologies specific to in situ breast cases. 13
15 Notes for slide 14 Remember that there were some new reportable histologies added to ICD-0-3 for 2018 the NAACCR Implementation Guidelines has the list of ALL new terms (including in situ). The link to the NAACCR 2018 Implementation Guidelines is listed on this slide. Be sure to refer to the HBOC guidelines for a complete list of included HBOC related insitu histologies. 14
16 Notes for slide 15 The inclusion criteria also includes all invasive ovarian, fallopian tube & primary peritoneal cases diagnosed at any age The list of excluded histologies also applies to ovarian/fallopian tube/primary peritoneal primaries (mesotheliomas, Kaposi s Sarcomas, leukemias or lymphomas are not included). The in situ breast cases are the only group that has a special list of included histologies. 15
17 16
18 Notes for slide 17 This portion of the training presentation will go over each HBOC data item and explain what information it records, the coding structure and instructions on how to code the data item. The data item HBOC Genetic Counseling Referral records if the patient was referred to a genetic counselor, or if the patient was referred for some other comprehensive cancer risk assessment consultation, specifically for HBOC. The information on Genetic Counseling may be noted in the medical record by any health care provider it doesn t have to be a note or report specifically from the genetic counselor. 17
19 Notes for slide 18 This coding structure and description for this data item is given on this slide. We have tried, as much as possible, to use the same coding structure that is used in the SEER manual & to be consistent throughout all the data items. For each data item there is a Code 9, which is to be used when it is unknown or there isn t any information for that particular item. This is a familiar code used consistently in all cancer registry coding structures. IMPORTANT!!! All of the HBOC data items should be left blank for cases prior to 2019 and for those cases not meeting the criteria. 18
20 Notes for slide 19 This slide includes some instructions on how to apply the codes for any given case. Code 0 should be used when there is a statement or record that the patient was referred for genetic counseling but declined the referral. Code 1 is used when the medical record documents that there WAS a referral to genetic counseling (Important: a confirmation that the counseling was actually done is NOT needed). This data item just records that the patient was referred for genetic counseling. Code 6 is used when it is documented that genetic counseling was not recommended (this information needs to be stated in the medical record not just assumed). Code 9 is used for cases where there isn t any mention of a referral or it is unknown if it was recommended or there isn t any information in the medical record. 19
21 Notes for slide 20 Here is an example of how the Genetic Counseling data item should be coded. You would use code 0. The patient was referred for counseling but, after finding out his insurance wouldn t pay, declined it. 20
22 Notes for slide 21 For this example code 9 would be used because, even though options were discussed, there wasn t a specific mention of a referral, so it is unknown if a referral was given. 21
23 Notes for slide 22 The next data item is HBOC Germline BRCA Testing. This data item is for testing specifically for the BRCA gene. This data item will identify those patients that have been tested for a BRCA gene. The test requires DNA, taken from blood, saliva or a cheek swab. The testing may be for BRCA alone or in combination with a multi-gene panel test for other gene mutations. Be aware of that as you look for gene test reports in the records; other gene test may be included 22
24 Notes for slide 23 The coding structure for BRCA Testing is much the same as for genetic referral, with the addition of code 7. Leave the field blank if the case is prior to 2019 or the case doesn t meet criteria. 23
25 Notes for slide 24 Use code 0 when the medical record states that testing is recommended but the patient declines. Code 1 is used when the medical record states BRCA testing was done. Code 6 should be used when testing was not recommended. Code 7 is used to record that testing was ordered, but the results aren t in the medical record. Code 9 is recorded when there isn t any mention of BRCA testing or it is unknown if testing was ordered. 24
26 Notes for slide 25 Here is an example of how the BRCA Testing data item should be coded. In this case the correct code would be 1 because BRCA testing was done. Even though it was done prior to the collection of this data item, it can still be recorded as having been done. 25
27 Notes for slide 26 Code 9 would be correct for this example. There isn t any information about what happened after the patient moved. 26
28 Notes for slide 27 The next four data items address the results of the BRCA testing, specifically for BRCA 1, BRCA 2, and BRCA testing not specified as 1 or 2. A data item for results of testing for other gene mutations other than BRCA has also been included. The data item HBOC - BRCA 1 Results is specific to this gene and should be coded from the genetic test report. If the report is not available, the results can be coded from a statement in the medical record from any health care provider or genetic counselor. 27
29 Notes for slide 28 The coding structure for this data item includes codes for a negative or positive result and also a Variant of Unknown Significance which indicates a change in the DNA with unclear impact on the gene protein. 28
30 Notes for slide 29 Code 0 is used when the medical record states that the results of testing were negative. Use code 1 when results are stated to be positive. Code 3 is for cases when the results describe a Variant of Unknown Significance. Code 9 is used for cases where results are unknown, no information is found in the medical record, or when no BRCA 1 testing is done. 29
31 Notes for slide 30 The codes and structure for data Item HBOC Germline BRCA 2 Results are the same as for BRCA 1 Results, but specifically for BRCA 2 results. The same guidelines apply. Code from the test report if available; otherwise use a statement from a health care provider or genetic counselor. 30
32 Notes for slide 31 The coding structure is the same as for BRCA 1 Results. 31
33 Notes for slide 32 Apply the codes for this data item the same as for the BRCA 1 Results data item Use code 9 for cases where no BRCA 2 testing is done 32
34 Notes for slide 33 The data item HBOC Germline BRCA NOS Results is used if BRCA tests results are given, but it is unknown if it is for BRCA 1 or 2 The coding guidelines are the same as for BRCA 1 & 2 results. This data item would be coded if testing results are not specific to BRCA 1 or 2. 33
35 Notes for slide 34 The coding structure for this data item is the same as for BRCA 1 and BRCA 2 testing results, with the addition of code 8, which is used for cases where BRCA 1 and/or BRCA 2 testing is specified. 34
36 Notes for slide 35 This data item is coded when results are given, either negative, positive or VUS, but BRCA 1 or BRCA 2 results are not specified. Code 8 should be used when BRCA 1 and/or BRCA 2 results are specified (results are coded in BRCA 1 and/or BRCA 2 results data items). 35
37 Notes for slide 36 The data item HBOC Germline Other Gene Results, Not BRCA is used to report the results of germline testing that is NOT BRCA, when multi-gene panel testing is done. The testing could be part of the same report as BRCA. Be sure not to overlook other test results included in a multi-gene panel test. 36
38 Notes for slide 37 Here are some examples of other gene testing you may see. There are many, many others that may show up on a test report. 37
39 Notes for slide 38 The coding structure for this data is simple, only negative, positive or unknown results are coded. A test that results in a Variant of Unknown Significance should be coded as negative (code 0). 38
40 Notes for slide 39 Assign code 0 when test results are negative, normal or a variant of unknown significance (VUS is typically re-classified as negative). Code 1 is used when the test results are positive and when a report lists both a positive & VUS in genes other than BRCA. Code 9 should be used when other tests results are unknown, there isn t any information in the medical record or no other gene testing was done. 39
41 Notes for slide 40 This is an example of how to code the data item for other gene results that are not BRCA. The testing results showed both a positive mutation and a variant of unknown significance. The correct code is 1, positive for mutation. A positive mutation is coded when present or when conflicting results are given from different tests. 40
42 Notes for slide 41 Medical records differ from facility to facility and the information you need to code these data items may be found in various places. As you look for this information you will become familiar with where it is most likely located in your institution s records, or if it is part of the medical record you are abstracting for. The best source, of course, will be the genetic counselor s report; other possible sources could be oncology reports, consultation reports and outside clinical records. 41
43 Notes for slide 42 PLEASE read the Guidelines!! They contain the information on how to code each data item, give examples for many of the codes, and give the criteria for what cases to include. Remember that for cases diagnosed before 2019 or for cases that don t meet the criteria ALL HBOC fields are left blank. 42
44 Notes for slide 43 For eligible cases diagnosed after 1/1/2019 ALL HBOC fields must be coded (not left blank); in some cases all fields may be coded 9. 43
45 44
46 We ask that, from now on, you submit your questions for coding these data items to our Inquiry Form. If you do not have access to this system for submitting questions, please contact us and we will help with setting it up for you. This is the forum we use for all coding, abstracting & staging questions and want all questions for these new data items to be submitted there. We are adding a new question on the form so you can let us know your inquiry is about an HBOC data item. Those questions will be routed to Heather Cheney, the UCR CTR who has worked on this project and who helped formulate the coding structure and write the guidelines. She is our resident authority on all things HBOC related. You can also contact either of the genetic counselors (their s were listed at the end of their slides) for questions related to genetics & interpreting testing reports. 45
47 Here is what the revised form will look like. 46
48 This concludes our presentation on the new Hereditary Breast and Ovarian Cancer data items. We hope the instructions have been helpful and that adding these data items will not create a burden for you as you abstract the eligible cases. 47
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