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 1 – 2: Was non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS) present? (report infectious pneumonia in the infection section of the appropriate follow-up form)
IPn refers to inflammation of the alveolar walls. Acute respiratory distress syndrome (ARDS) typically refers to fluid build-up within the alveoli. In either case, gas exchange is impaired resulting in oxygen deprivation. Both conditions can result from infectious or non-infectious causes.
Idiopathic pneumonia syndrome (IPS) refers to all non-infectious lung injuries that occur early after HCT (within 100 – 120 days) including: peri-engraftment respiratory distress syndrome (PERDS), interstitial pneumonitis without a pathogen, radiation / drug-induced lung injury, or transfusion-associated lung injury (TRALI).
Indicate if non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS) was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS) in the reporting period.
- Non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS) resolved in a prior reporting period and then recurred in the current reporting period.
If non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS) 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:
- Non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS) was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS) was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
If non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS) was not present in the current reporting period or unknown if present, select Not present.
Report infectious pneumonia in the infection section of the appropriate follow-up form.
Questions 3 – 4: Select diagnostic methods for non-infectious IPn or ARDS / IPS (other than radiographic studies) (check all that apply)
Select all methods used to diagnose the non-infectious IPn or ARDS / IPS, excluding radiographic studies.
- Bronchoalveolar lavage (BAL): A procedure in which a bronchoscope is guided into the lower respiratory system. Fluid is emitted from the bronchoscope and then collected for further examination.
- Transbronchial biopsy: A procedure in which forceps on the end of the bronchoscope are used to collect lung tissue samples for further examination.
- Open / thoracoscopic (video-assisted thoracic surgery, VATS) lung biopsy: An open lung biopsy is a procedure in which an incision is made between the ribs to collect a sample of lung tissue for further examination. A thorascopic lung biopsy is a procedure in which an incision is made to the chest and an endoscope is used to collect samples of lung tissue.
- Autopsy: A post-mortem procedure used to determine the cause of death and to evaluate other disease present at the time of death.
- Other diagnostic test: If a diagnostic test, other than radiographic studies was performed, specify the test.
- No diagnostic tests done: If no diagnostic tests (other than radiographic studies) were performed, select this option.
Questions 5 – 6: Did non-infectious IPn or ARDS / IPS resolve?
Indicate if IPn or ARDS / IPS 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 7 – 8: Was another non-infectious pulmonary abnormality present? (e.g., bronchiolitis obliterans, COP / BOOP, diffuse alveolar hemorrhage)
Indicate if any other non-infectious pulmonary abnormality was present in the current reporting period. See below for a list of other non-infectious pulmonary abnormalities.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with non-infectious pulmonary abnormality in the reporting period.
- Non-infectious pulmonary abnormality resolved in a prior reporting period and then recurred in the current reporting period.
If non-infectious pulmonary abnormality 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:
- Non-infectious pulmonary abnormality was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Non-infectious pulmonary abnormality was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
If non-infectious pulmonary abnormality was not present in the current reporting period or unknown if present, select Not present.
Questions 9 – 10: Select other non-infectious pulmonary abnormality experienced (e.g., bronchiolitis obliterans, COP / BOOP, diffuse alveolar hemorrhage)
Specify the other non-infectious pulmonary abnormality.
- Bronchiolitis obliterans (BO): An airway obstruction as a result of inflammation of the bronchioles. This complication typically occurs late after HCT. It is often a manifestation of chronic GVHD. If bronchiolitis obliterans is a result of chronic GVHD, confirm that bronchiolitis obliterans was also reported in the chronic GVHD section of the appropriate follow-up form.
- Cryptogenic organizing pneumonia (COP) / Bronchiolitis obliterans with organizing pneumonia (BOOP): An idiopathic form of pneumonia which affects different parts of the lungs including the bronchioles and alveoli. This complication typically occurs late after an infusion.
- Diffuse alveolar hemorrhage (DAH): Bleeding into the alveolar space typically resulting from an injury to the pulmonary blood vessels.
- Other non-infectious pulmonary abnormality: Any other non-infectious pulmonary abnormalities not already captured in the above categories. Do not report pleural effusions here.
Questions 11 – 12: Select diagnostic methods for non-infectious pulmonary abnormality (other than radiographic studies) (check all that apply)
Select all methods used to diagnose the non-infectious pulmonary abnormality, excluding radiographic studies.
- Bronchoalveolar lavage (BAL): A procedure in which a bronchoscope is guided into the lower respiratory system. Fluid is emitted from the bronchoscope and then collected for further examination.
- Transbronchial biopsy: A procedure in which forceps on the end of the bronchoscope are used to collect lung tissue samples for further examination.
- Open / thoracoscopic (video-assisted thoracic surgery, VATS) lung biopsy: An open lung biopsy is a procedure in which an incision is made between the ribs to collect a sample of lung tissue for further examination. A thorascopic lung biopsy is a procedure in which an incision is made to the chest and an endoscope is used to collect samples of lung tissue.
- Autopsy: A post-mortem procedure used to determine the cause of death and to evaluate other disease present at the time of death.
- Other diagnostic test: If a diagnostic test, other than radiographic studies was performed, specify the test.
- No diagnostic tests done: If no diagnostic tests (other than radiographic studies) were performed, select this option.
Questions 13 – 14: Did non-infectious pulmonary abnormality resolve?
Indicate if the non-infectious pulmonary abnormality 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 15 – 16: Did the recipient receive endotracheal intubation or mechanical ventilation?
Endotracheal intubation or mechanical ventilation may be used for respiratory failure or for airway protection from severe mucositis.
Invasive positive pressure ventilation is delivered via an endotracheal tube. Do not include non-invasive positive pressure ventilation that is delivered through an alternate interface (e.g., facemask).
Indicate whether the recipient received endotracheal intubation or mechanical ventilation (invasive positive pressure ventilation) during the reporting period. If Yes, report the date when endotracheal intubation or mechanical ventilation was started. If the recipient was intubated multiple times within the reporting period, report the first date of intubation.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 17 – 18: Was the recipient successfully extubated?
Indicate if the recipient was successfully extubated during the reporting period. The intent of this question is to capture if the outcome of the recipient was successful. If Yes, report the date extubated. If the recipient was extubated multiple times within the reporting period, report the last date extubated.
If the recipient was not successfully extubated, passed away while intubated, or was transitioned to comfort care, select No.
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) |
|---|---|---|---|---|
| Q17 – 18 | 4/24/2026 | Add | Clarified intent of the successful extubation question: Indicate if the recipient was successfully extubated during the reporting period. The intent of this question is to capture if the outcome of the recipient was successful. If Yes, report the date extubated. If the recipient was extubated multiple times within the reporting period, report the last date extubated. If the recipient was not successfully extubated, passed away while intubated, or was transitioned to comfort care, select No. | Added for clarification |
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