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.
Questions 153 – 154: Were cataracts present?
Cataracts are the loss of transparency in the lens of the eye.
Indicate if cataracts were 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 cataracts in the reporting period.
If cataracts 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 cataracts. 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:
- Cataracts were diagnosed pre-infusion and persisted into the Day 100 reporting period.
When this is diagnosed post-infusion, do not report cataracts if it continued from a previous reporting period into the current reporting period, even if it was present.
If cataracts were 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.
Questions 155 – 156: Was iron overload requiring therapy present?
Iron overload is a condition characterized by having too much iron in the body. Therapy includes phlebotomy and iron chelation.
Indicate if iron overload requiring therapy was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with iron overload requiring therapy in the reporting period.
- Iron overload requiring therapy in a prior reporting period and then recurred in the current reporting period.
If iron overload requiring therapy 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:
- Iron overload requiring therapy was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Iron overload requiring therapy was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
If iron overload requiring therapy was not present in the current reporting period or unknown if present, select Not present.
Questions 157 – 158: Specify therapy given for iron overload (check all that apply)
Indicate the therapy given for iron overload in the current reporting period. Select all therapies. If Other therapy is selected, specify.
Questions 159 – 160: Was the recipient still receiving therapy for iron overload at the date of contact for this reporting period?
Specify if the recipient was still receiving iron overload therapy at the contact date for the current reporting period. If No, specify the therapy end date.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 161 – 162: Did iron overload requiring therapy resolve?
Indicate if iron overload requiring therapy resolved during the reporting period. If Yes, report the resolution date. The resolution date is the date when the notes specify the condition as resolved and / or medications to treat the condition were completed.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 163 – 164: Was mucositis requiring therapy present?
Mucositis is the inflammation and ulceration of mucous membranes that line the digestive tract, usually due to chemotherapy and radiotherapy. Specify if mucositis was present in the current reporting period.
Indicate if mucositis requiring therapy 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 mucositis in the reporting period.
If mucositis 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 mucositis. 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:
- Mucositis was diagnosed pre-infusion and persisted into the Day 100 reporting period.
When this is diagnosed post-infusion, do not report mucositis if it continued from a previous reporting period into the current reporting period, even if it was present.
If mucositis 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.
This question is only enabled for the Day 100 reporting period.
Questions 165: Specify maximum OMS grade
Report the maximum OMS grade in the reporting period using the following guidelines:
- 0 (none): Normal mucosa with no mucositis
- I (mild): Oral soreness, erythema
- II (moderate): Oral erythema, ulcers, solid diet tolerated
- III (severe): Oral ulcers, liquid diet only
- IV (life-threatening): Oral ulcers, oral alimentation impossible
Questions 166 – 167: Was another impairment / disorder present?
An other impairment / disorder should be reported for any clinically significant impairment / disorder that is not listed above.
Specify if an other impairment / disorder was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with the other impairment / disorder in the reporting period.
- The other impairment / disorder resolved in a prior reporting period and then recurred in the current reporting period.
Report Persisted in the following scenarios:
- The other impairment / disorder was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- The other impairment / disorder was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
If the other impairment / disorder was not present in the current reporting period or unknown if present, select Not present.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| Q153 – 154 | 4/24/2026 | Add | Clarified intent of question and when to report ‘not present’: Cataracts are the loss of transparency in the lens of the eye. Indicate if cataracts were 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 cataracts were 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 |
| Q163 – 164 | 4/24/2026 | Add | Clarified intent of question and when to report ‘not present’: Mucositis is the inflammation and ulceration of mucous membranes that line the digestive tract, usually due to chemotherapy and radiotherapy. Specify if mucositis was present in the current reporting period. Indicate if mucositis requiring therapy 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 mucositis 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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