Q1-6: Functional Status

!If the female recipient or the male recipient’s female partner is pregnant at the time of submitting this form (created on-demand) or is pregnant on the reported contact date for the current reporting period (created as a result of reporting a pregnancy on the Cellular Therapy Essential Data Follow-Up (4100) form), submit the form and return to update the form when the outcome of the pregnancy is known.

Question 1: Estimated delivery date

Report the estimated delivery date, as documented within the medical record. If the date is not documented, seek physician clarification.

Question 2: Was the recipient pregnant at the time of this report? (Female only)

Indicate Yes or No if the recipient (female only) was pregnant at the time of completing this form.

If this form was created using the on-demand function, indicate if the recipient is pregnant at the time of submitting this form.

If this form was generated as a result of reporting on the Cellular Therapy Essential Data Follow-Up (4100) form, indicate if the recipient is pregnant on the contact date for the corresponding reporting period in which the pregnancy was first reported.

If the recipient is pregnant at the time of completing this form (on-demand) or pregnant on the reported contact date for the current reporting period, select Yes and submit the form.

Question 3: Was the recipient’s female partner pregnant at the time of this report (Male only)

Indicate Yes or No if the male recipient’s female partner was pregnant at the time of this report.

If this form was created using the on-demand function, indicate if the male recipient’s female partner is pregnant at the time of submitting this form.

If this form was generated as a result of reporting on the Cellular Therapy Essential Data Follow-Up (4100) form, indicate if the male recipient’s female partner is pregnant on the contact date for the corresponding reporting period in which the pregnancy was first reported.

If the male recipient’s female partner is pregnant at the time of completing this form (on-demand) or pregnant on the reported contact date for the current reporting period, select Yes and submit the form.

Question 4: Specify the outcome of the pregnancy

Indicate the outcome of the pregnancy. The Unknown option should be used sparingly and only when no information can be obtained regarding the outcome.

If the outcome of the pregnancy is either Live birth, at term or Live birth, premature, continue with question 5.

If the outcome of the pregnancy is either Intrauterine fetal death, Spontaneous abortion, Elective abortion or Unknown, submit the form.

Question 5: Were there congenital abnormalities? (Live birth)

Congenital abnormalities are defined as structural or functional abnormalities that occur during intrauterine life.

Examples of structural abnormalities include cleft palate, club foot, missing or abnormal limbs, etc.

Examples of functional abnormalities include mental retardation, Down syndrome, etc.

Indicate Yes or No if the baby was diagnosed with a structural or functional congenital abnormality(ies).

Questions 6: Delivery date

Specify the date of delivery. If the exact delivery date is not known but the month and year is known, use the process described for reporting partial or unknown dates in the General Instructions, Guidelines for Completing Forms and select the Date estimated box.

Signature Lines:
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Section Updates:

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