Q40 – 53: Renal Impairment / Disorder

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.

*Reporting Multiple Renal Impairments / Disorders
Complete Was a renal impairment / disorder present through Date renal impairment / disorder resolved questions to report multiple renal impairments / disorders by adding an additional instance in the FormsNet3^SM application.

Questions 40 – 41: Was a renal impairment / disorder present?

Symptoms of renal failure include dehydration, nausea, blood in the urine, and / or swelling of extremities. Acute kidney failure is classified as three stages:

• Stage 1
  • Serum creatinine is 1.5 – 1.9 x baseline, or
  • ≥ 0.3 mg / dL (≥ 26.5 µmol / L) increase
• Stage 2
  • Serum creatinine is 2.0 – 2.9 x baseline
• Stage 3
  • Serum creatinine is 3.0 x baseline, or
  • Increase serum creatinine ≥ 4.0 mg / dL (≥ 353.6 µmol / L), or
  • The start of renal replacement therapy, or
  • In recipients < 18 years, decrease in eGFR to < 35 ml / min / 1.73 m²

Kidney failure is considered chronic when there is persistent decrease in glomerular filtration to < 60 ml / min /1.73 m² for three or more months.

Indicate if a renal impairment / disorder (stage 2 or 3 acute kidney failure and / or chronic kidney failure) was present in the current reporting period.

Report Developed in the following scenarios:

• This is the first time the recipient was diagnosed with a renal impairment / disorder in the reporting period.
• Renal impairment / disorder resolved in a prior reporting period and then recurred in the current reporting period.

If the renal impairment / disorder 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:

• Renal impairment / disorder was diagnosed pre-infusion and persisted into the Day 100 reporting period.
• Renal impairment / disorder was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
• For cellular therapy, if the renal impairment / disorder 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 the renal impairment / disorder was not present in the current reporting period or unknown if present, select Not present.

Do not report stage 1 acute kidney failure.

Questions 42 – 44: Did the recipient experience acute renal failure requiring dialysis?

Indicate if the recipient experienced stage 2 or 3 acute kidney failure, requiring dialysis (for less than three months) in the current reporting period. If Yes, specify the dialysis start date for acute kidney failure.

If dialysis was started in a prior reporting period and continued into the current reporting period, report the start date as Previously reported. If dialysis was stopped in prior reporting period but restarted in the current reporting period, report the start date as the date when dialysis was restarted.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Questions 45 – 46: Was the recipient still on dialysis for acute renal failure at the date of last contact?

Specify if the recipient was still on dialysis for acute kidney failure on the contact date for the current reporting period. If No, specify the dialysis end date.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Questions 47 – 49: Did the recipient experience chronic renal failure requiring dialysis?

Indicate if the recipient experienced chronic kidney failure, requiring dialysis in the current reporting period. If Yes, specify the dialysis start date for chronic kidney failure.

If dialysis was started in a prior reporting period and continued into the current reporting period, report the start date as Previously reported. If dialysis was stopped in prior reporting period but restarted in the current reporting period, report the start date as the date when dialysis was restarted.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Questions 50 – 51: Was the recipient still on dialysis for chronic renal failure at the date of last contact?

Specify if the recipient was still on dialysis for chronic kidney failure on the contact date for the current reporting period. If No, specify the dialysis end date.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Questions 52 – 53: Did the renal impairment / disorder resolve?

Indicate if the renal impairment / disorder is 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.

Section Updates:

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