The purpose of this section is to capture any impairments or disorders present during the current reporting period, regardless of treatment or intervention, unless otherwise specified. Review each impairment or disorder description to determine whether treatment or intervention is required for reporting the condition.
Question 140: Did the recipient experience avascular necrosis?
Avascular necrosis, also known as coagulation necrosis or ischemic necrosis, is localized tissue death due to inadequate oxygen to the cells.
Indicate if the recipient experienced avascular necrosis in the current reporting period. The intent of this question is to capture each instance of avascular necrosis occurring in the reporting period.
If the recipient did not have avascular necrosis in the current reporting period or is unknown, select No.
Question 141: Date of avascular necrosis onset
Specify the date of the avascular necrosis.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 142 – 143: Did the recipient have surgery for avascular necrosis during this reporting period?
Indicate if the recipient required surgery for avascular necrosis during the current reporting period. If Yes, specify the surgery date.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 144 – 145: Was osteonecrosis of the jaw present?
Osteonecrosis of the jaw is when jaw bones weaken and die due to potent antiresorptive medications such as bisphosphonates or RANKL inhibitors, infection, steroid use, and cancer treatment, including radiation.
Indicate if osteonecrosis of the jaw was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with osteonecrosis of the jaw in the reporting period.
- Osteonecrosis of the jaw resolved in a prior reporting period and then recurred in the current reporting period.
If osteonecrosis of the jaw Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- Osteonecrosis of the jaw was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Osteonecrosis of the jaw was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
- For cellular therapy, if osteonecrosis of the jaw was diagnosed pre-infusion and persisted into the one-year reporting period (without resolution since the pre-infusion diagnosis) as this form will not come due until the one-year reporting period.
If osteonecrosis of the jaw was not present in the current reporting period or unknown if present, select Not present.
Questions 146 – 147: Was osteoporosis present?
Osteoporosis is where the bones become weak and brittle due to losing bone mass faster than it is created from aging.
Indicate if osteoporosis was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with osteoporosis in the reporting period.
If osteoporosis Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.
Do not report a recurrence of osteoporosis. Only the first occurrence is captured.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- For transplant, if osteoporosis was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- For cellular therapy, if osteoporosis was diagnosed pre-infusion and persisted into the one-year reporting period (without resolution since the pre-infusion diagnosis) as this form will not come due until the one-year reporting period.
When this is diagnosed post-infusion, do not report osteoporosis if it continued from a previous reporting period into the current reporting period, even if it was present.
If osteoporosis was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present select Not present.
Question 148: Did the recipient experience an osteoporotic fracture?
Osteoporotic fracture is where a fracture occurs due to low bone mineral density.
Indicate if the recipient experienced an osteoporotic fracture in the current reporting period. The intent of this question is to capture each instance of an osteoporotic fracture occurring in the reporting period.
If the recipient did not have an osteoporotic fracture in the current reporting period or is unknown, select No.
Question 149: Date of osteoporotic fracture
Specify the date of the osteoporotic fracture.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| Q146 – 147 | 4/24/2026 | Add | Clarified intent of question and when to report ‘not present’: Osteoporosis is where the bones become weak and brittle due to losing bone mass faster than it is created from aging. Indicate if osteoporosis was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If osteoporosis was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present select Not present. | Added for clarification |
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