Q42 – 83: Product Analysis at Infusion

!Product Analysis
This section is intended to capture the values for the actual product volume infused and should reflect the product infused regardless of when the analysis occurred. For cord blood units, values reported should reflect the product analysis performed post wash.

*Cord Blood Units
Only report product testing performed by the center’s laboratory. Product testing performed by the cord blood bank is captured in the Product Transport and Receipt section of this form and should not be reported in the Product Analysis at Infusion section. If the center only tests for viability, report the date of analysis, product volume, and viability.

Question 42: Date of product analysis

Report the date the product was analyzed. If the product was analyzed multiple times after arriving at the center, report the latest date the product was analyzed. The date of product analysis is not necessarily the date of the product infusion.

If a product is analyzed multiple times prior to product infusion, the type of product will determine which cell counts to report. See below for more information:

• Fresh product
  • If an unmanipulated, fresh product was analyzed multiple times prior to infusion, the most recent complete cell analysis, not taking into account reanalyzing the viability (if applicable), should be reported.
    • Example 1: Upon receiving a fresh product, the center completes a TNC, CD34, and viability analysis. The product was not manipulated but prior to infusion, a small sample was collected to analyze the viability.
      • Analysis date: The most recent analysis date (when the small sample was collected to analyze the viability again)
      • Cell counts: TNC and CD34 after receiving the product and the most recent viability (the small sample collected to reanalyze the viability)
• Cryopreserved product
  • If a cryopreserved product is infused, report the complete cell analysis, not taking into account reanalyzing the viability (if applicable), adjusted for the volume infused, performed by the transplant center. If the cryopreserved product is contained in multiple bags, only report the sum of the cell counts for the bags infused. If the cryopreserved product is contained in a single bag, report the cell counts adjusted for the volume infused. In the rare scenario where a complete cell analysis performed post-thaw, this analysis should be reported; however, this is unlikely as there is usually not enough product to perform a complete cell analysis post-thaw.
    • Example 2: Upon collecting an autologous PBSC product, the center completed a TNC, CD34, and viability analysis. The product is contained in one bag and cryopreserved. The bag is thawed, viability analyzed, and the product was infused.
      • Analysis date: Post-thaw analysis date (when the viability was analyzed)
      • Cell counts: TNC and CD34 values prior to cryopreservation and the post-thaw viability
    • Example 3: Upon collecting an autologous PBSC product, the center completed a TNC, CD34 and viability analysis. The product is contained in one bag and cryopreserved. The bag is thawed, the TNC, CD34, and viability are analyzed, and the product was infused.
      • Analysis date: Post-thaw analysis date (when the TNC, CD34, and viability were analyzed)
      • Cell counts: The post-thaw TNC, CD34, and viability
    • Example 4: Upon collecting an autologous PBSC product, the center completed a TNC, CD34 and viability analysis. The product is contained in one bag and cryopreserved. The bag is thawed, the TNC and viability are analyzed, and the product was infused.
      • Analysis date: Post-thaw analysis date (when the TNC and viability were analyzed)
      • Cell counts: TNC and CD34 values prior to cryopreservation and the post-thaw viability
    • Example 5: Upon collecting an autologous PBSC product, the center completed a TNC, CD34 and viability analysis. The product is separated into three bags and cryopreserved. Two of the three bags were thawed, the viability is analyzed, and the product was infused.
      • Analysis date: Post-thaw analysis date (when the viability was analyzed)
      • Cell counts: TNC and CD34 values prior to cryopreservation, adjusted for the volume of the two bags infused (sum of the volume and cell counts), and the post-thaw viability
    • Example 6: Upon collecting an autologous PBSC product, the center completes a TNC, CD34, and viability analysis. The product is separated into three bags and cryopreserved. Two of the three bags were thawed, the TNC and viability were analyzed, and the product was infused.
      • Analysis date: Post-thaw analysis date (when the TNC and viability were analyzed)
      • Cell counts: TNC and CD34 values prior to cryopreservation, adjusted for the volume of the two bags infused (sum of volume and cell counts), and the post-thaw viability
        • The post-thaw TNC is not captured
• Processed product
  • Report the last analysis performed prior to product infusion.
    • Example 7: Upon receiving a PBSC product, the center completes a TNC, CD34, and viability analysis and then RBC reduced the product. After processing, the CD34 and viability are analyzed.
      • Analysis date: Post-processing analysis date
      • Cell counts: The post-processing CD34 and viability values
        • The pre-processing TNC is not captured
    • Example 8: Upon receiving a CBU product, the center thaws the CBU, completes a TNC, CD34, and viability analysis, washes the CBU, and the product was infused.
      • Analysis date: Pre-processing analysis date (when the TNC, CD34, and viability were analyzed)
      • Cell counts: TNC, CD34, and viability prior to processing
      • Example 9: Upon receiving a CBU product, the center thaws the CBU, completes a TNC, CD34, and viability analysis, washes the CBU, reanalyzes the TNC and viability, and the product was infused.
      • Analysis date: Post-processing analysis date (when the TNC and viability were reanalyzed)
      • Cell counts: TNC and CD34 prior to processing and the post-processing viability

Question 43: Total volume of product received by the center plus additives

Enter the total volume of the product plus additives in the bag(s) infused. Report the volume in milliliters (mL). The total volume reported should be the actual volume given to the recipient.

*TNC, Nucleated Red and White Blood Cells: Since total nucleated cells consist of both nucleated red and white blood cells, it is possible to calculate a missing value if the two other values are present on lab reports. Centers do not need to calculate and report these lab values if they don’t appear on the laboratory paperwork.

Questions 44 – 45: Total nucleated cells (TNC) (whole product)

Specify if the TNC count was quantified on the analysis date reported above. If Done, report the absolute number of the cells, not cells per kg.

Occasionally, cell differential results may be “corrected” in order to remove cells such as nRBCs. The CIBMTR would like to have uncorrected data submitted in these fields. Some labs report corrected cell counts, others report uncorrected cells counts. Some even report both. If your lab report does not clearly indicate whether the TNC is corrected or uncorrected, ask someone in the lab to help you determine which is correct. This will most likely be the same every time, so you would not need to check for each patient. If this information is not clearly indicated on the lab report, please ensure this is somewhere in your center SOPs. If the only value available to you is the corrected TNC, you may calculate the uncorrected TNC with the formula below. Please be sure to carefully check your math and the units reported to ensure that the information on the form is correct. To determine the uncorrected TNC count, use the following formula (Adapted from Essential Laboratory Mathematics by CW Johnson, DL Timmons, PE Hall (2003), pg 175.):

• Example 4: If the corrected WBC is 17.96×10^6/mL, the product volume is 390 mL, and the nRBCs per 100 WBCs is 12.8 (using the formula above when considering cells/mL): 8.96 × 10⁸ total uncorrected TNC.

*Viability Testing
When reporting the viability, it is important to consider the sample source used for viability testing. If viability is performed on the entire product, report the viability for the Total Nucleated Cells (TNC) and not the individual cell types (i.e., CD34+, CD3+). However, if viability was performed only on select cell types (i.e., viability was performed on both the CD34+ and CD3+ cells), then report the viability for both CD34+ and CD3+. Similarly, if a product is CD34+ selected and viability is performed on the product post-manipulation, the viability should only be reported for CD34+ cells.

*Method of Cell Viability
If both flow cytometry based and Trypan Blue methods of viability testing are performed, report the flow cytometry-based results.

Questions 46 – 47: Viability of TNC

Specify if the viability of the total nucleated cells was quantified. If Done, report the percentage of viable cells.

If the viability was not assessed, or if it is unknown whether viability was tested, report Not done.

If your center’s laboratory assay only measures viable cells, report the number of viable cells in Total nucleated cells, select Done for this question, and report the viability as 100%.

Questions 48 – 49: Method of testing TNC viability

Indicate the method of testing viability.

• Flow cytometry based: Includes 7-AAD, AOPI, and AOEB. 7-AAD (7-aminoactinomycin D) and Propidium iodide are compounds that can stain dead cells but will not cross the membrane of living cells. Cytometric techniques are used to calculate the percentage of viable cells in a sample.
• Trypan Blue: A technique where the dead cells become stained when in contact with the compound, but living cells remain impermeable to the dye. Cells are counted under a microscope to determine the percentage of viable cells in a sample.

If the cell viability was tested using a different method, select Other method and specify the method.

*TNC, Nucleated Red and White Blood Cells: Since total nucleated cells consist of both nucleated red and white blood cells, it is possible to calculate a missing value if the two other values are present on lab reports. Centers do not need to calculate and report these lab values if they don’t appear on the laboratory paperwork.

Questions 50 – 51: Nucleated white blood cells

Specify if the nucleated white blood cells (also known as leukocytes) were quantified on the analysis date reported above. If Done, report the absolute number of cells, not cells per kg.

Questions 52 – 53: Mononuclear cells

The total mononuclear cell count includes lymphocytes and monocytes. Specify if the mononuclear cells were quantified on the analysis date reported above. If Done, report the absolute number of cells, not cells per kg.

Questions 54 – 55: Nucleated red blood cells

Specify if the nucleated red blood cells (also known as normoblasts) were quantified on the analysis date reported above. If Done, report the absolute number of cells, not cells per kg.

Questions 56 – 57: CD34+ cells

Specify if the CD34+ cells were quantified on the analysis date reported above. If Done, report the absolute number of cells, not cells per kg.

*Viability Testing
When reporting the viability, it is important to consider the sample source used for viability testing. If viability is performed on the entire product, report the viability for the Total Nucleated Cells (TNC) and not the individual cell types (i.e., CD34+, CD3+). However, if viability was performed only on select cell types (i.e., viability was performed on both the CD34+ and CD3+ cells), then report the viability for both CD34+ and CD3+. Similarly, if a product is CD34+ selected and viability is performed on the product post-manipulation, the viability should only be reported for CD34+ cells.

*Method of Cell Viability
If both flow cytometry based and Trypan Blue methods of viability testing are performed, report the flow cytometry-based results.

Questions 58 – 59: Viability of CD34+ cells

If the viability of the CD34+ cells was quantified, select Done and report the percentage of viable cells. If the viability was not assessed, or if it is unknown whether viability testing was performed, report Not done.

If your center’s laboratory assay only measures CD34+ viable cells, report the number of viable CD34+ cells in Total number of CD34+ cells, select Done for this question, and report the viability as 100%.

Questions 60 – 61: Method of testing CD34+ cell viability

Indicate the method of testing viability.

• Flow cytometry based: Includes 7-AAD, AOPI, and AOEB. 7-AAD (7-aminoactinomycin D) and Propidium iodide are compounds that can stain dead cells but will not cross the membrane of living cells. Cytometric techniques are used to calculate the percentage of viable cells in a sample.
• Trypan Blue: A technique where the dead cells become stained when in contact with the compound, but living cells remain impermeable to the dye. Cells are counted under a microscope to determine the percentage of viable cells in a sample.

If CD34+ cell viability was tested using a different method, select Other method and specify the method.

Questions 62 – 63: CD3+ cells

Specify if the CD3+ cells were quantified on the analysis date reported above. If Done, report the absolute number of cells, not cells per kg.

*Method of Cell Viability
If both flow cytometry based and Trypan Blue methods of viability testing are performed, report the flow cytometry-based results.

Questions 64 – 65: Viability of CD3+ cells

If the viability of the CD3+ cells was quantified, select Done and report the percentage of viable cells. If the viability was not assessed, or if it is unknown whether viability was assessed, report Not done.

If your center’s laboratory assay only measures CD3+ viable cells, report the number of viable CD3+ cells in Total number of CD3+ cells, select Done this question, and specify the viability as 100%.

Questions 66 – 67: Method of testing CD3+ cell viability

Indicate the method of testing viability.

• Flow cytometry based: Includes 7-AAD, AOPI, and AOEB. 7-AAD (7-aminoactinomycin D) and Propidium iodide are compounds that can stain dead cells but will not cross the membrane of living cells. Cytometric techniques are used to calculate the percentage of viable cells in a sample.
• Trypan Blue: A technique where the dead cells become stained when in contact with the compound, but living cells remain impermeable to the dye. Cells are counted under a microscope to determine the percentage of viable cells in a sample.

If the CD3+ cell viability was tested using a different method, select Other method and specify the method.

Questions 68 – 69: CD3+CD4+ cells

Specify if the CD3+CD4+ cells were quantified on the analysis date reported above. If Done, report the absolute number of cells, not cells per kg.

Questions 70 – 71: CD3+CD8+ cells

Specify if the CD3+CD8+ cells were quantified on the analysis date reported above. If Done, report the absolute number of cells, not cells per kg.

Question 72: Were the colony-forming units (CFU) assessed after thawing? (Cord blood units only)

CFUs have been shown to be a predictor of engraftment. Indicate whether CFUs were assessed after thawing.

Question 73: Was there growth?

If CFUs were assessed after thawing, indicate whether growth was detected.

Questions 74 – 77: Indicate which assessments were carried out (check all that apply)

Select which CFU was assessed after thawing, select all that apply.

If the total CFU-GM (granulocyte / macrophages) was quantified, select Total CFU-GM and report the total CFU-GM as documented on the laboratory report.

If the total CFU-GEMM (granulocyte / erythrocyte / monocyte / megakaryocytes) was quantified, select Total CFU-GEMM and report the total CFU-GEMM as documented on the laboratory report.

If the total BFU-E (burst forming unit – erythroid) was quantified, select Total BFU-E and report the total BFU-E as documented on the laboratory report.

Do not report CFU per dish, per bag, or per kg.

Question 86: Question 78: Were any positive cultures (for bacterial or fungal infections) obtained from the product at the transplant center? (complete for all cell products)

Specify if any positive cultures were obtained from the product at the transplant center.
If cultures were obtained and positive, select Yes.

If cultures were not obtained or obtained and negative, select No.

If cultures are pending, select Pending. If these results are reported as Pending, transplant centers will be asked to update this field once the culture results are available.

Report Unknown in the following scenarios:

• If culture results are unavailable
• Culture assessments were not performed
  

*It is not known whether culture assessments were performed

*Organism Codes
The codes for Other organism should rarely be needed; check with the microbiology lab or physician before using them

Questions 79 – 83: Specify organism code(s)

Specify the isolated organism(s) detected using the organism code(s) from the pull-down options.

If a single product was split into multiple bags and one or more bags are contaminated, then all bags should be considered contaminated for the purpose of reporting data to the CIBMTR.

If multiple products are infused, and only one product is contaminated, then report the infection on the Hematopoietic Cellular Transplant (HCT) Infusion (2006) for the product that was contaminated (i.e., the uninfected product will be reported on a separate Hematopoietic Cellular Transplant (HCT) Infusion (2006) Form).

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.