Question 2: Date of actual contact with the recipient to determine medical status for this follow-up report:

Enter the date of actual contact with the recipient to evaluate medical status for this follow up report.

In general, the date of contact closest to the designated time point indicated on the form (e.g. Day+100, 6 months, or annual follow-up visit) should be reported. Report the date of actual contact with the recipient to evaluate medical status for the reporting period. Preferred evaluations include those from the cellular therapy physician, referring physician, or other physician currently assuming responsibility for the recipient’s care. In the absence of contact with a physician, other types of contact may include a documented phone call with the recipient, a laboratory evaluation, or any other documented recipient interaction on the date reported. If there was no contact on the exact time point, choose the date of contact closest to the actual time point.

Below, the guidelines show an ideal approximate range for reporting each post-cellular therapy time point:

Form Time Point Approximate Range
F4100 100 Days +/- 15 days (Day 85 – 115)
F4100 6 Months +/- 30 days (Day 150 – 210)
F4100 1 Year + 60 days (Day 365 – 425)
F4100 Annual reporting 2+ Years +/- 30 days (Months 23-25, 35-37, etc.)

Recipients are not always seen within the approximate ranges and some discretion is required when determining the date of contact to report. In that case, report the date closest to the date of contact within reason. The examples below assume that efforts were undertaken to retrieve outside medical records from the primary care provider, but source documentation was not available.

Example 1. The 100 day date of contact doesn’t fall within the ideal approximate range.
The recipient had an infusion on 1/1/18 and is seen regularly until 3/1/18. After that, the recipient was referred home and not seen again until 7/1/18 for a restaging exam and 7/5/18 for a meeting to discuss the results.

What to report:
100 Day Date of Contact: 3/1/18 (Since there was no contact closer to the ideal date of 4/11/18, this date is acceptable)
6 Month Date of Contact: 7/5/18 (note the latest disease assessment would likely be reported as 7/1/18)

Example 2. The 100 day date of contact doesn’t fall within the ideal approximate range and the recipient wasn’t seen again until 1 year post-HCT.
The recipient had an infusion on 1/1/18 and is seen regularly until 3/1/18. After that, the recipient was referred home and not seen again until 1/1/19 for a restaging exam and 1/4/18 for a meeting to discuss the results.

What to report:
100 Day Date of Contact: 3/1/18 (Since there was no contact closer to the ideal date of 4/11/18, this date is acceptable)
6 Month form: Indicate the recipient is lost to follow-up in FormsNet3
1 Year Date of Contact: 1/4/19 (note the latest disease assessment would likely be reported as 1/1/19)

Additional information:

A date of contact should never be used multiple times for the same recipient’s forms.

  • For example, 6/1/18 should not be reported for both the 6 month and 1 year. Instead, determine the best possible date of contact for each reporting period; if there is not a suitable date of contact for a reporting period, this may indicate that the recipient was lost to follow-up.

If the recipient has a disease evaluation just after the ideal date of contact, capturing that data on the form may be beneficial.

  • For example, if the recipient’s 90 day restaging exam was delayed until day 115 and the physician had contact with the recipient on day 117, the restaging exams can be reported as the latest disease assessment and day 117 would be the ideal date of contact, even though it is just slightly after the ideal approximate range for the date of contact.

Date of Contact & Subsequent Infusion

If the recipient has a subsequent infusion, report the date of contact as the day before the preparative regimen / systemic therapy begins for the subsequent infusion. If no preparative regimen / systemic therapy is given, report the date of contact as the day before the subsequent infusion. In these cases, actual contact on that day is not required, and the day prior to the initiation of the preparative regimen (or infusion, if no preparative regimen was given) should be reported. This allows every day to be covered by a reporting period and prevents overlap between infusion events.

Example 3. The recipient receives a subsequent HCT.
The recipient had a cellular therapy on 1/1/18 and was seen regularly through the first 100 days. During the 6 month reporting period, the recipient goes on to receive a subsequent HCT.

What to report
Regulatory requirements specify at least 15 years of follow-up data be collected on recipients of genetically modified cellular therapy products: The date of contact reported should be the date prior to the preparative regimen (or infusion, if no preparative regimen was given). Both HCT and cellular therapy forms will be completed but all applicable cellular therapy follow-up forms will be reset to the new event date (i.e., Forms 2450+4100 or 2100+4100).

Cellular therapy products where regulatory requirements do not specify follow-up reporting: The date of contact reported will be the date prior to the start of the preparative regimen for the subsequent infusion (in cases where no prep is given, it is the day prior to the infusion). Reporting on the cellular therapy event will end.

Example 4. The recipient receives a subsequent cellular therapy.
The recipient had a cellular therapy on 1/1/18 and was seen regularly through the first 100 days. During the 6 month reporting period, the recipient goes on to receive a subsequent cellular therapy.

What to report
The date of contact reported will be the date prior to the start of the systemic therapy for the subsequent infusion (in cases where no systemic therapy is given, it is the day prior to the infusion). Reporting on the first cellular therapy event will end. This is true for both genetically modified and non-genetically modified cellular therapy products.

Date of Contact & Death
In the case of recipient death, the date of death should be reported as the date of contact regardless of the time until the ideal date of contact. The date of death should be reported no matter where the death took place (inpatient at the transplant facility, at an outside hospital, in a hospice setting, or within the recipient’s home).
If the death occurred at an outside location and records of death are not available, the dictated date of death within a physician note may be reported. If the progress notes detailing the circumstances of death are available, request these records. These records are useful for completing required follow-up data fields and the cause of death data fields on this form. If the exact date of death is unknown, please view General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

Example 5. The recipient has died before their six month reporting period.
The recipient had an infusion on 1/1/18 and was seen regularly through the first 100 days. They had restaging exams on 4/4/18 and were seen on 4/8/18, and then died on 5/13/18 in the hospital emergency room.

What to report:
100 Day Date of Contact: 4/8/18 (note the latest disease assessment would likely be reported as 4/4/18)
6 Month Date of Contact: 5/13/18 (though the death does not occur within the ideal approximate range for 6 months)

Example 6. The recipient has died after their six month time point.
The recipient had an infusion on 1/1/18 and was seen regularly through the first 100 days. The recipient had restaging exams on 4/22/18 and was seen on 4/23/18. Based on findings in the restaging exam, the recipient was admitted for additional treatment. The disease was found to be refractory on a 6/25/18 restaging exam, and the recipient was discharged to hospice on 7/8/18. The hospital was notified via telephone that the recipient died on 7/16/18.

What to report:
100 Day Date of Contact: 4/23/18 (note the latest disease assessment would likely be reported as 4/22/18) 6 Month Date of Contact: 7/16/18 (note the latest disease assessment would likely be reported as 6/25/18)

Question 3: Specify the recipient’s survival status at the date of last contact:

Indicate the clinical status of the recipient on the date of actual contact for follow-up evaluation. If the recipient has died, answers to subsequent questions should reflect the recipient’s clinical status between the date of last report and their death. The center must also complete a Recipient Death Data Form (Form 2900). If both HCT and CT forms are being completed, the death should be reported on the Post-HSCT Data (2100) or Post-Transplant Essential Data (2450).

Last modified: Nov 18, 2020

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