Question 41: Specify the timepoint in the product preparation phase that the product was analyzed:

For all products, the “at infusion” timepoint must be reported. The “at infusion” timepoint should only report the values for the actual product volume infused.

For cord blood units, both a “product arrival” and an “at infusion” timepoint must be reported.

Cord Blood Units: Centers are reminded to only report product testing performed by their 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 section. If the transplant center only tests for viability, report the timepoint, date of analysis, product volume, and viability.

Question 42: Date of product analysis:

Report the date the product was analyzed. For the “At Infusion” timepoint, if the product was analyzed multiple times after arriving at the transplant center, report the latest date the product was analyzed with the associated cell counts prior to infusion.

Question 43: Total volume of product plus additives:

Enter the total volume of the product plus additives in the bag(s) for the timepoint. Report the volume in either milliliters (mL) or grams (g). For the “at infusion” timepoint, the total volume should be the actual volume given to the recipient.

Question 44-45: Report the total nucleated cells (TNC) (Includes nucleated red and nucleated white cells)

Report “done” if the TNC count was quantified at the specified timepoint. Report the absolute number of the cells, not cells per kg. If “done”, go to question 45. If the TNC was “not done,” go to questions 50.

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.):

For example, if the corrected WBC is 17.96×106/mL, the product volume is 390 mL, and the nRBCs per 100 WBCs is 12.8 (using the formula above when considering cells/mL):

Questions 46-47: Viability of total nucleated cells:

If the viability of the total nucleated cells was quantified, select “done” and report the percentage of viable cells in question 47. If the viability was “not done” or “unknown” go to question 50. If your center’s laboratory assay only measures viable cells, report the number of viable cells in question 45, select “done” for question 46, and report a viability of 100% in question 47.

Questions 48-49: Method of testing cell viability:

Indicate the method of testing viability.

Flow cytometry based: 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 is 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 in question 49.

Questions 50-51: Report the nucleated white blood cells:

Report “done” if the nucleated white blood cells (also known as leukocytes) were quantified at the specified timepoint. Report the absolute number of the cells, not cells per kg. If “done,” go to question 51. If the nucleated white blood cell count was “not done,” go to questions 52.

Questions 52-53: Report the mononuclear cells:

The total mononuclear cell count includes lymphocytes and monocytes. Report “done” if the mononuclear cells were quantified at the specified timepoint. Report the absolute number of the cells, not cells per kg. If “done,” go to question 53. If the mononuclear cell count was “not done,” go to questions 54.

Questions 54-55: Report the nucleated red blood cells:

Report “done” if the nucleated red blood cells (also known as normoblasts) were quantified at the specified timepoint. Report the absolute number of the cells, not cells per kg. If “done,” go to question 55. If the nucleated red blood cell count was “not done,” go to questions 56.

Questions 56-57: Report the CD34+ cells:

Report “done” if the CD34+ cells were quantified at the specified timepoint. Report the absolute number of the cells, not cells per kg. If “done,” go to question 57. If the CD34+ cell count was “not done,” go to questions 62.

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 in question 59. If the viability was “not done” or “unknown” go to question 62. If your center’s laboratory assay only measures viable cells, report the number of viable cells in question 57, select “done” for question 58, and report a viability of 100% in question 59.

Questions 60-61: Method of testing cell viability:

Indicate the method of testing viability.

Flow cytometry based: 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 is 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 in question 61.

Questions 62-63: Report the CD3+ cells:

Report “done” if the CD3+ cells were quantified at the specified timepoint. Report the absolute number of the cells, not cells per kg. If “done,” go to question 63. If the CD3+ cell count was “not done,” go to questions 68.

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 in question 65. If the viability was “not done” or “unknown” go to question 68. If your center’s laboratory assay only measures viable cells, report the number of viable cells in question 63, select “done” for question 64, and report a viability of 100% in question 65.

Questions 66-67: Method of testing cell viability:

Indicate the method of testing viability.

Flow cytometry based: 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 is 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 in question 67.

Questions 68-69: Report the CD3+CD4+ cells:

Report “done” if the CD3+CD4+ cells were quantified at the specified timepoint. Report the absolute number of the cells, not cells per kg. If “done,” go to question 69. If the CD3+CD4+ cell count was “not done,” go to questions 74.

Questions 70-71: Viability of CD3+CD4+ cells:

If the viability of the CD3+CD4+ cells was quantified, select “done” and report the percentage of viable cells in question 71. If the viability was “not done” or “unknown” go to question 74. If your center’s laboratory assay only measures viable cells, report the number of viable cells in question 69, select “done” for question 70, and report a viability of 100% in question 71.

Questions 72-73: Method of testing cell viability:

Indicate the method of testing viability.

Flow cytometry based: 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 is 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 in question 73.

Questions 74-75: Report the CD3+CD8+ cells:

Report “done” if the CD3+CD8+ cells were quantified at the specified timepoint. Report the absolute number of the cells, not cells per kg. If “done,” go to question 75. If the CD3+CD8+ cell count was “not done,” go to questions 80.

Questions 76-77: Viability of CD3+ cells:

If the viability of the CD3+CD8+ cells was quantified, select “done” and report the percentage of viable cells in question 77. If the viability was “not done” or “unknown” go to question 80. If your center’s laboratory assay only measures viable cells, report the number of viable cells in question 75, select “done” for question 76, and report a viability of 100% in question 77.

Questions 78-79: Method of testing cell viability:

Indicate the method of testing viability.

Flow cytometry based: 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 is 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 in question 79.

Question 80: 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. If the CFUs were assessed, continue with question 81. If no CFU assessments were performed, continue with question 88.

Question 81: Was there growth?

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

Questions 82-83: Total CFU-GM

Indicate if the total CFU-GM (granulocyte/macrophages) was quantified. If the CFU-GM was quantified, report “done” and continue with question 83. Report the total CFU as documented on the laboratory report. Do not report CFU per dish, per bag, or per kg.

Questions 84-85: Total CFU-GEMM

Indicate if the total CFU-GEMM (granulocyte/erythrocyte/monocyte/megakaryocytes) was quantified. If the CFU-GEMM was quantified, report “done” and continue with question 85. Report the total CFU as documented on the laboratory report. Do not report CFU per dish, per bag, or per kg.

Questions 86-87: Total BFU-E

Indicate if the total BFU-E (burst forming unit – erythroid) was assessed. BFU-E indicates the presence of erythroid precursor cells. If the BFU – E was quantified, report “done” and continue with question 87. Report the total BFU-E as documented in the laboratory report. Do not report BFU per dish, per bag, or per kg.

Question 88: Were any positive cultures (for bacterial or fungal infections) obtained from the product at the transplant center? (complete for all cell products)

If positive cultures were obtained, select “yes” and continue with question 89.

If positive cultures were not obtained, select “no” and continue with question 94.

If cultures are pending, select “pending” and continue with question 94. If these results are reported as “pending” transplant centers will be asked to update this field once the culture results are available.

If culture results are unknown, select “unknown” and continue with question 94.

The codes for “other organism, specify” (codes 198, 209, 219 and 259) should rarely be needed; check with your microbiology lab or HCT physician before using them.

Questions 89-93: Specify organism code(s)

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 purposes of reporting data to the CIBMTR.

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

If the results were positive, select the isolated organism(s) using the pull down options in FormsNet3.

Last modified: Mar 23, 2020

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