Q1 – 25: Infection Episode

Question 1: Organism

This field is auto-populated to match the fungus reported on the Post-Infusion Follow-Up (2100). Review the value to ensure it is accurate. A Fungal Infection Post-Infusion Data (2146) Form will come due for each applicable infection reported on the Post-Infusion Follow-Up (2100) Form so it is imperative to identify the fungal infection to which this form will correspond.

If multiple infections of the same fungus are reported during the same reporting period, the center must complete a Fungal Infection Post-Infusion Data (2146) Form for each infection instance, or episode, reported

Question 2: Date of infection diagnosis

This field is auto-populated to match the date reported on the Post-Infusion Follow-Up (2100) Form. Review the value to ensure it is accurate. See the Post-Infusion Follow-Up section of the manual for further instructions on reporting the date of diagnosis.

If multiple infections of the same virus are reported in the same reporting period, the diagnosis reported will clarify for which infection episode the form is being completed.

*Diagnostic Results
Report all testing that had positive results and which indicated the fungal infection was present. Do not report negative or indeterminate / equivocal testing.

Questions 3 – 25: Diagnostic testing

If the recipient was diagnosed with multiple fungal infections during the reporting period, a separate Fungal Infection Post Infusion Data (2146) Form must be completed for each organism. Ensure that the test results reported in these questions reflect only the assessments used to identify the infection or organism for the form being completed.

Only report methods performed and samples collected (or sites assessed for radiological findings) within 14 days (+/ -) of the diagnosis date reported above.

For each assessment, specify if the results were positive for the fungal infection using the following guidelines:

• Yes: Assessment was completed within 14 days (+ / -) of the infection diagnosis date and positive for signs of the fungal infection being reported. If Yes, specify the site(s) of where the infection was detected. If the site is not listed, select the ‘other’ option and specify.
• No: Assessment was not or unknown if performed within 14 days (+ / -) of the infection diagnosis date, was completed but not positive for the reporting fungal infection, or the results were ‘equivocal’ or ‘indeterminate.’

If the significance of the test result is unclear, seek clinician clarification.

Diagnostic Assessments

• Radiographic findings (e.g., x-ray, CT, or MRI): Includes imaging such as x-ray, CT, PET, or MRI. These assessments can show infection but do not identify the organism.
• Pathology: Biopsy or fine needle aspirate samples are evaluated by microscopy (without incubation). If culture or staining was performed, report under those methods. Review the results and / or interpretation section of the pathology report.
• Culture: Samples are incubated in media to detect fungal growth. Results are generally found in the microbiology / virology section of the medical record and are determined based on colony formation and growth, in addition to microscopic assessment. If staining was done after incubation, report under the staining method below.
• KOH / Calcofluor / Giemsa stain: Samples, usually fluids like sputum or wash samples, are stained and examined under microscopy to determine if fungal cells are present (positive) or absent (negative).
  • KOH: Potassium hydroxide (fungal wet prep)
  • Calcofluor: Binds fungal cell walls
  • Giemsa: Often used for Histoplasma
• Galactomannan assay: Uses ELISA method to detect galactomannan (specific to Aspergillus genus) in a sample. This test does not determine the Aspergillus subtype and additional testing is required.
• 1,3-Beta-D-glucan (Fungitel) assay: Uses ELISA method to detect beta-D-glucan (found in Candida, Aspergillus, and others). This test does not determine the fungal subtype and additional testing is required.
• PCR assay: Detects fungal DNA using polymerase chain reaction (PCR). Presence and classification of fungi are assessed by identifying DNA sequences unique to specific fungi. Results are generally found in the microbiology / virology or the molecular pathology section of the medical record.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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