Question 311: Was the intent to complete the HCT procedure (conditioning, infusion, and period of recovery from neutropenia) as an outpatient?

Report Yes if the plan was to complete all conditioning, infusions, and recovery in the outpatient setting. If the plan was to admit the patient for any part of the transplant, report No and continue with question 312.

Report Yes even if the recipient required an unplanned admission.

Question 312: Did the recipient require an unplanned admission?

Report whether the recipient required an unplanned admission during the reporting period. This includes unplanned admissions for the purpose of completing an infusion as well as admissions to address any post-infusion complications. Report Yes if an unplanned admission was required. If the recipient did not require an unplanned admission, report No.

Questions 313 – 314: Was the recipient discharged prior to the date of contact?

If the recipient was discharged from the hospital during the reporting period, report Yes and report the date the recipient was discharged. If the recipient was admitted to the hospital multiple times during the reporting period, report first discharge date. If the recipient was not discharged from the hospital during the reporting period, report No.

If the recipient died without ever being discharged from the hospital, report No.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 315: Total number of inpatient days (day 0 to day 100) in first 100 days post-HST

Enter the total number of inpatient days (including day 0). If the recipient was discharged and readmitted during the first 100 days, the total should include days hospitalized after being readmitted. When counting the total number of inpatient days, count either the day of admission or the day of discharge; do not count both.

If the recipient receives a subsequent infusion prior to day 100, do not include the start date of the preparative regimen for the subsequent infusion (or the date of the subsequent infusion if no preparative regimen was given).

Questions 316 – 318: Recipient height (most recent)

These questions will only be enabled / answered for pediatric patients (≤ 16 years old) when the form visit ID is 6 months or greater. These questions will be disabled / not answered for all recipients on the day 100 follow-up form.

Indicate whether the recipient’s height is known. If Known, report the recipient’s most recent height, specify the units, and report the date the height was measured. If the recipient’s height was not measured during the reporting period, report Unknown.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Questions 319 – 321: Recipient weight: (most recent)

Indicate whether the recipient’s weight is known. If Known, report the recipient’s most recent weight, specify the units, and report the date the weight was measured. If the recipient’s weight was not measured during the reporting period, report Unknown.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Questions 322 – 324: Functional status

The CIBMTR uses the Karnofsky / Lansky scale to determine the functional status of the recipient on the date of contact. The Karnofsky Scale is designed for recipients aged 16 years and older and is not appropriate for children under the age of 16. The Lansky Scale is designed for recipients one year old to less than 16 years old. If the recipient is less than one year old, leave questions 322 – 324 blank.

Select the appropriate performance scale, Karnofsky or Lansky, based on the recipient’s age. Using this scale, select the score (10-100) that best represents the recipient’s activity status immediately prior to the date of last actual contact. Acceptable performance scores include those recorded within 14 days prior to 100 Day and Six-Month contact dates. For the annual reporting periods, performance scores may be reported if dictated within one month of the contact date. The only valid scores are 10-100; zero is not a valid response for this scale, nor are values not ending in zero, such as “85.” The Karnofsky / Lansky scale can be found in Appendix L.

Recipient performance status is a critical data field that has been determined to be essential for all outcome-based studies. Determination of performance status is ideally performed by a healthcare provider. Centers are encouraged to put tools in place to facilitate this collection. If a Karnofsky / Lansky score is not documented in the source documentation (e.g., inpatient progress note, physician’s clinic note), data professionals are encouraged to discuss a determination with the physician or mid-level health care provider (NPs and PAs) rather than make an assignment themselves, based on inadequate information. Documentation from an RN who has been trained and authorized to determine performance scores may also be used.

The CIBMTR recognizes that some transplant centers prefer to assign and use the ECOG performance score as opposed to the Karnofsky / Lansky score. Although the ECOG and Karnofsky / Lansky performance score systems are based on similar principles, the scales are not the same. For example, the Karnofsky / Lansky scale is described in 10 categories, whereas the ECOG performance status is reported in six categories. Due to the overlap between the two systems, an ECOG score of “one” can represent either “80” or “90” on the Karnofsky / Lansky scale; whereas, a Karnofsky / Lansky score of “80” or “90” is converted directly to an ECOG score of “one.” Therefore, the Karnofsky / Lansky scale can be more accurately converted into ECOG.

However, for centers that collect only an ECOG performance score, CIBMTR will make the following accommodations when auditing the source data:

  • Centers assigning ECOG scores should do so using standard practices to ensure accuracy.
  • For the purposes of CIBMTR reporting, conversion of ECOG to Karnofsky / Lansky should follow a standard and consistent practice to account for the lack of direct mapping. This practice should be clear and reproducible.

Question 325: Was the recipient pregnant at any time in this reporting period? (Female only)

Indicate whether the recipient was pregnant at any time during the reporting period. Skip this question for male recipients.

If Yes, complete the Pregnancy (3501) form also. The Previously reported option should only be used if the same pregnancy instance has already been reported on a Pregnancy (3501) form that was created as an unscheduled form (on-demand). See examples below.

Contact CIBMTR Center Support with questions.

Question 326: Was the recipient’s female partner pregnant at any time in this reporting period? (Male only)

Indicate whether the recipient’s female partner was pregnant at any time during the reporting period. Skip this question for female recipients.

If Yes, complete the Pregnancy (3501) form also. The Previously reported option should only be used if the same pregnancy instance has already been reported on a Pregnancy (3501) form that was created as an unscheduled form (on-demand). See examples below.

Contact CIBMTR Center Support with questions.

Example 1. A recipient or recipient’s female partner becomes pregnant at Day +68 and is reported at the time when the Day 100 Post-Infusion Follow-Up (2100) form is completed. The recipient or recipient’s female partner is still pregnant at the six-month reporting period and then delivers the baby during the one-year reporting period. The recipient / recipient’s female partner does not become pregnant again.

For the Day 100 reporting period, question 325 or 326 should be reported as Yes and the Pregnancy (3501) form will be completed to report the pregnancy information. For the six-month and one-year reporting periods, Previously reported should be selected since the recipient / recipient’s female partner was still pregnant during the reporting period and a prior Pregnancy (3501) form has already been submitted for the pregnancy. For all future reporting periods, select No.

Example 2. A recipient or recipient’s female partner becomes pregnant during the seven-year reporting period and the transplant center decided to create the Pregnancy (3501) form as an unscheduled form in FormsNet3SM to report the pregnancy information immediately since a Post-Infusion Follow-Up for seven-year reporting period will not come due. When the eight-year Post-Infusion Follow-Up (2100) form is completed, Previously reported, will be reported since a prior Pregnancy (3501) form has already been submitted for the pregnancy.

Questions 327 – 329: Has the recipient smoked tobacco cigarettes since the date of last report?

The intent of this question is to determine the recipient’s history of smoking cigarettes only. Do not report the use of cigars, pipe tobacco, chewing tobacco, or other drugs. Report Yes if the recipient has smoked tobacco cigarettes since the date of the last report and capture the average number of packs (20 cigarettes per pack) smoked a day, if known. If the recipient has not smoked tobacco cigarettes since the date of the last report, or their smoking history is not known, report No or Unknown.

Questions 330 – 331: Specify the category which best describes the recipient’s current occupation

Select the category that best describes the recipient’s current occupation. If the recipient is younger than school-aged, select Under school age. If Other is selected, specify the recipient’s occupation.

Only one work status may be reported. If a recipient has multiple work opportunities during the current reporting period, report the highest level of work being performed. For example, full time work would be reported over part time work.

Questions 332 – 334: What is the recipient’s current or most recent work status?

Select the work status that best describes the recipient’s current or most recent employment during this reporting period. If the recipient is Retired, specify their retirement status. If the recipient’s status is anything other than Full time, indicate if the recipient claimed medical disability.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
Q311 5/19/2022 Modify Updated the ‘go to’ instructions” Report Yes if the plan was to complete all conditioning, infusions, and recovery in the outpatient setting. If the plan was to admit the patient for any part of the transplant, report No and continue with question 315 312. Due to changes in form validations
Q311 – 334 2/1/2022 Modify Updated the red box above question 311 to explain when questions 311 – 315 will come due: Questions 311 – 315 The Functional Status section will only be answered on the day 100 form. Centers will not be able to complete these questions this section for any subsequent reporting periods. Update for clarification
Q325 – 326 5/18/2022 Add Combined Follow-Up blue instruction box added: In scenarios where both HCT and cellular therapy forms are being completed, duplicate questions will exist between the Cellular Therapy Essential Data Follow-Up (4100) form and the Post-HCT Data (2100) or Post-Transplant Essential Data (2450) form. To reduce the reporting burden, duplicate questions, including the pregnancy questions, on the Post-HCT Data (2100) form are disabled when there is a cellular therapy and an HCT. Added for clarification
Last modified: May 19, 2022

Need more help with this?
Don’t hesitate to contact us here.

Was this helpful?

Yes No
You indicated this topic was not helpful to you ...
Could you please leave a comment telling us why? Thank you!
Thanks for your feedback.