February 2018 Forms Instruction Manual Updates

In case you missed them, here are the changes made to the Forms Instruction Manual during the month of February. Check the Getting Started  page of the Forms Instruction Manual for a list of the most recent updates. Updates made after March 2015 are always available for reference in the Historical Manual Updates  section.

Date
Manual Section
Add/ 
Remo ve/ Modify
Description
2/28/18
2402: Disease Classification
Add
Added the following instruction for question 283.
When a transformation has occurred (e.g., follicular lymphoma (FL) transformed to DLBCL), count the response number (CR1, REL2, etc.) beginning with the transformed lymphoma (in this case the DLBCL). Do not include the responses to the lymphoma sub-type prior to the transformation.
2/27/18
2402: Disease Classification
Add
Added instruction for questions 281-282.
If multiple scores are documented, report the highest.
2/22/18
2110: AML Post-Infusion Data
Modify
Added ( red) and removed ( blue) text from instructions for questions 51-52.
If any testing for molecular markers 
occurred
detected the recipient's primary disease during the reporting period, report "Yes" for question 51 and report the date the sample was collected in question 52. 
If molecular marker testing did not detect disease at any time during the reporting period, report "No" for question 51 and go to question 63. 
If molecular marker testing was not performed during the reporting period, report "No Unknown" go to question 63.
2/22/18
2110: AML Post-Infusion Data
Modify
Added ( red   ) and removed ( blue ) text from the beginning of section Q51-103: Disease Detection Since Date of Last Report
If testing 
by a particular
 
method 
for molecular or cytogenetic markers / abnormalities was not done during the reporting period or it is not known whether testing was performed, report "Unknown" for 
that method 
those methods (question 51 and 70). If testing by flow cytometry, clinical / hematologic assessment, or other assessment was not done during the reporting period or it is not known whether testing was performed, report "No" for those methods (questions 63, 80, and 87).
2/22/18
2110: AML Post-Infusion Data
Add
Added text ( red) to the  Questions 51-103 warning box.
For questions 51, 63, 70, 80, and 87, report
"No" or "Unknown" (see instructions below) if the recipient did not relapse, have persistent or minimal residual disease even if testing was performed.
2/22/18
2111: ALL Post-Infusion Data
Modify
Added ( red) and removed (bluetext from instructions for questions 48-49.
If any testing for molecular markers 
occurred 
detected the recipient's primary disease during the reporting period, report "Yes" for question 48 and report the date the sample was collected in question 49. 
If molecular marker testing did not detect disease at any time during the reporting period, report "No" for question 48 and go to question 49. If 
molecular marker testing was not performed during the reporting period, report "No Unknown" go to question 53.
2/22/18
2111: ALL Post-Infusion Data
Modify
Added ( red) and removed  (blue) text from the beginning of section Q48-94: Disease Detection Since Date of Last Report
If testing 
by a particular method 
for molecular or cytogenetic markers / abnormalities 
was not done during the reporting period or it is not known whether testing was performed, report "Unknown" for that method 
those methods (question 48 and 61). If testing by flow cytometry, clinical / hematologic assessment, or other assessment was not done during the reporting period or it is not known whether testing was performed, report "No" for those methods (questions 54, 71, and 78).
2/22/18
2111: ALL Post-Infusion Data
Add
Added text ( red) to the  Questions 48-94 warning box.
For questions 48, 54, 61, and 78, report "No" or 
"Unknown" (see instructions below) if the recipient did not relapse, have persistent or minimal residual disease even if testing was performed.
2/20/18
Appendix C: Cytogenetic Assessments
Add
Added table below figure 3 to explain karyotype findings.
2/20/18
2100: Post-HCT Follow-Up
Add
Added text (red) to the instructions for question 304. This instruction was / is available on the form.
Report the maximum chronic GVHD involvement 
since the date of last report, based on clinical grade.

2/20/18
2100: Post-HCT Follow-Up
Add
Added the following instruction for question 303. This instruction was / is available on the form.
Report the extent of chronic GVHD since the date of last report.
2/20/18
2100: Post-HCT Follow-Up
Add
Added text ( red) to the instructions for question 302. This instruction was / is available on the form.
Report the maximum chronic GVHD involvement 
since the date of last report, based on clinical grade, as documented by the recipient's primary care provider.
2/15/18
4000: Cellular Therapy Essential Data Pre-Infusion
Modify
Added text ( red) to the instructions for question 49.
If the indication for cellular therapy is relapsed, persistent, or progressive disease (post-HCT), the indication should be the primary disease for which the cellular therapy is being given.
If the recipient is receiving post-HCT cellular therapy (e.g. DCI/DLI) for relapsed, persistent, or progressive disease, the indication should be recorded as "malignant hematologic disorders" and complete a new F2402 for the disease that has relapsed/persisted/progressed.
2/14/18
2402: Disease Classification
Remove
Removed incorrect instruction ( blue) from question 271. 
If the histology reported at infusion (question 268) is a transformation from CLL, 
indicate "Yes," and go to question 272. 
Also, complete the disease classification for CLL.
 
2/13/18
2100: Post-HCT Follow-Up
Add
Added Liver Toxicity Prophylaxis note box above the instructions for question 490.
2/13/18
4000: Cellular Therapy Essential Data Pre-Infusion
Remove
Removed the instruction below from section Q68-93: Disease Assessment at Last Evaluation Prior to Cellular Therapy.
Specify the method(s) of disease detection below. For each method used, if the result was positive report the first date the disease was detected; if the result was negative report the last date the method was used prior to cellular therapy.
2/13/18
2116: PCDPost-HCT
Add
Added Daratumumab note box to the instructions for questions 69-90.
2/13/18
2016: PCDPre-HCT
Add
Added Daratumumab note box to the instructions for questions 196-222.
2/12/18
Appendix C: Cytogenetic Assessments
Add
Added the following description of constitutional abnormalities.
Karyotyping may also detect constitutional abnormalities. These are abnormalities present since birth. Examples include, but are not limited to, trisomy 21 and Klinefelter's syndrome. It is not necessary to report constitutional abnormalities when reporting karyotyping results.
2/9/18
Appendix C: Cytogenetic Assessments
Modify
Version 2 of Appendix C: Cytogenetic Assessments of the Forms Instruction Manual released.
2/7/18
2000: Recipient Baseline
Modify
Updated the list of fungal species that require Form 2046 to be completed. Items added are in ( red). Items removed are ( blue). This list is provided in the instructions for questions 58-59.
Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, Other Aspergillus specify, Aspergillus NOS,
Aspergillus terreus, Aspergillus ustus, Blastomyces (dermatitidis), Candida albicans, Candida non-albicans, Cryptococcus gattii, Cryptococcus neoformans, Fusarium (all species), Histoplasma (capsulatum), Mucorales (all species), Mucormycosis, Rhizopus (all species), Scedosporium (all species), Zygomycetes NOS, Suspected fungal infection.
2/2/18
2006: Hematopoietic Stem Cell Transplant (HCT) Infusion
Modify
Removed text (blue) from the instructions for question 272.
Indicate Yes if the donor was hospitalized for
complications 
during or after the collection for any reason.
Indicate "No" if the donor was not hospitalized as an inpatient or if the donor was admitted to an observation unit and discharged in less than 24 hours.

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