June 2018 Forms Instruction Manual Updates

In case you missed them, here are the changes made to the Forms Instruction Manual during the month of June. 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/Remove/Modify Description
6/25/18 2150: Viral Infections Modify Added (in red below) and removed (struck out below) text from the instructions for reporting infection status at the time of evaluation for this reporting period (question 77):  If the status of the infection is not documented in the HCT/ cellular therapy physician's note summarizing their last evaluation performed during the reporting period, obtain documentation from the provider indicating which option to report.
For reporting purposes, centers should indicate "Ongoing" if the infection is still present, but cannot be considered improved or resolved.
  • Ongoing: Infection is still present, but cannot be considered improved or resolved
  • Improved: Still on treatment, but responding to treatment and no longer showing signs / symptoms of infection
  • Resolved: Treatment completed
  • Unknown
6/25/18 2150: Viral Infections Modify Added (in red below) further instruction on reporting therapy (question 51):  Report "Yes" if the recipient received any antiviral medication between seven days prior to the date of diagnosis (refer to question two) and the date of contact for the reporting period (refer to the date of contact reported on the corresponding Post-HCT Follow-Up Data Form). 
Report all therapy received regardless of the infection being treated.
6/22/18 4100 Cellular Therapy Essential Data Follow-Up Modify Added (in red below) further instruction on reporting symptoms in a reporting period: 
If "yes" is reported for a symptom, report the date of diagnosis (YYYY-MM-DD) of each symptom and indicate if the symptom was explained entirely by non-CRScauses (e.g. infection, therapy). If a symptom occurs multiple times within the same reporting period (e.g. fever), report the first occurrence.
6/1/18 2400: Pre-TED Modify Re-formatted the reporting instructions for pre-HCT CMV-antibody results (question 94) and included the following additional consideration (in red below):
Documented history of "reactive"  CMV: In cases where a recipient has a documented history of a "reactive"  CMV test and does not have a history of  IVIGor blood transfusions from a  CMV positive donor, "reactive" should be reported for the  CMV status even if the  CMV test is repeated during the pre- HCT work-up phase and is "non-reactive".
6/1/18 AML Response Criteria Add Added (in red below) further instruction on reporting the CRi response criteria: 
Transfusion independent 
(Please note, if the physician documents transfusion dependence related to treatment and not the patient's underlying  AML, CRi can be reported)
6/1/18 ALL Response Criteria Add Added (in red below) further instruction on reporting the CRi response criteria: 
Transfusion independent 
(Please note, if the physician documents transfusion dependence related to treatment and not the patient's underlying  ALL, CRi can be reported)

Questions, feedback, or requests may be submitted directly on the manual website using the Feedback Feature at the bottom of each page. For more information on how to submit feedback,  click here .