Q38-46: Hepatic Assessments

Question 38: Was a liver MRI conducted?

Indicate if a liver MRI was conducted at any time between diagnosis and the start of the preparative regimen / infusion. If a liver MRI was performed, report Yes. If multiple liver MRIs were performed, report the most recent results. If a liver MRI was not conducted or if no information is available to determine if a liver MRI was performed, report No or Unknown, respectively and go to question 41.

Questions 39 – 40: What was the liver iron content (LIC)?

Transfusions for hemolytic diseases such as Sickle Cell Disease (SCD), can often lead to iron build up or accumulation in the liver and other target organs. Liver iron content (LIC) is commonly used to measure total iron storage. Common methods of assessment include, but are not limited to, liver biopsy, T2 MRI, and FerriScan.

If liver iron content (LIC) was measured by the liver MRI reported above, report Known and provide the liver iron content value and unit of measure as documented on the MRI. If LIC testing was not performed or no information is available to determine if LIC testing was performed, report Unknown and go to question 41.

LIC results should be reported in mg Fe / g liver dry weight, g Fe / kg liver dry weight, or µm Fe / g liver dry weight. If laboratory reports at your center provides LIC results in any other units of measure, ensure appropriate conversions are conducted.

Questions 41 – 42: Was a liver biopsy performed?

Evaluation of liver tissue may be necessary to determine the extent of the recipient’s disease. Indicate if a liver biopsy was performed at any time between diagnosis and the start of the preparative regimen / infusion. If a liver biopsy was performed, report Yes and provide the date of the most recent liver biopsy. This date should reflect the date the sample was collected for analysis. If a liver biopsy was not performed or if no information is available to determine if a liver biopsy was performed, report No or Unknown and go to question 47.

*Note: Hepatic Assessments
Questions 43 – 46 should be answered based on the same liver biopsy reported in question 42.

Questions 43 – 44: Was there evidence of fibrosis?

Indicate if there was evidence of fibrosis from the liver biopsy reported above. If Yes, indicate the type of fibrosis.

• Bridging fibrosis: Bands of fibrous tissue and collagen which span portal spaces and / or centrilobular spaces creating a “bridge-like” appearance
• Periportal fibrosis: Fibrous expansion of portal fields with fibrosis extending along the terminal portal veins.
  

Report No in the following scenarios:

• There was no evidence of fibrosis from the reported liver biopsy
• Fibrosis was identified but the type was not bridging fibrosis or periportal fibrosis.
  

If documentation is unclear if fibrosis was present or the type of fibrosis identified, seek physician clarification.

Question 45: Was there evidence of cirrhosis?

Indicate if there was evidence of cirrhosis from the liver biopsy reported above. If cirrhosis was identified, report Yes. If cirrhosis was not identified or no information is available to determine if cirrhosis was present, report No.

Question 46: Is a copy of the biopsy report attached?

Indicate whether the liver biopsy report is attached to this form. For instructions on how to attach documents in FormsNet3[SM], refer to the Training Guide.

Section Updates:

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