Centers must complete the Form 2006 for each product when the recipient is assigned to the Comprehensive Report Form track. Centers must also complete the Form 2006 for the following product types when the recipient is assigned to the Transplant Essential Data track:
- NMDP donor products
- NMDP and non-NMDP cord blood units
Additionally, all transplant centers (TED-only and Comprehensive Report Form) participating in the Related Sample Repository must complete the Form 2006 for all non-NMDP donor products when a research sample is collected.
For more information see General Instructions, Center Type and Data Collection Forms.
The Form 2006 is designed to capture product- and infusion-specific information for all pTroducts given to a recipient as part of a Hematopoietic Stem Cell Transplant (HCT). This includes cells given prior to the HCT for reasons other than engraftment. In addition to use in research, this information is used for quality assurance measures, both by the NMDP and the Cord Blood Banks.
If more than one type of HCT product is infused, each product type must be analyzed and reported on a separate form. Two different products from the same donor (for example, PBSC and bone marrow), require two 2006 forms; one for each product.
However, a series of collections from the same donor that uses the same collection method and mobilization cycle, even if the collections are performed on different days, should be considered a single product.
Q1-3: Pre-Collection Therapy
Q4-7: Product Collection
Q8-21: Product Transport and Receipt
Q22-40: Product Processing/Manipulation
Q41-93: Product Analysis
Q94-143: Product Infusion
Q144-170: Donor/Infant Demographic Information
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
|5/5/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||The following instructions were added for buffy coat enriched for question question 33: Buffy coat enriched: Buffy coat enrichment is performed to reduce/remove mature erythrocytes and plasma. Buffy coat enrichment performed as part of the cryopreservation process should not be reported as product processing.|
|5/5/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||Red warning box added above quetion 33: Product Processing as Part of Cryopreservation: Product processing performed as part of the cryopreservation process should not be reported as a separate process. For example, plasma reduction / removal performed as part of the cryopreservation process should not be reported as product processing.|
|3/9/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||Product Processing blue note box added above question 33: Product Processing: Wash and dilution, both which generally apply to cord blood units, are now included as processing options, though they may not be classified as such by laboratories. If dilution is performed as part of washing, dilution should not need be reported. Only report the primary procedure. See the Steps in Manipulation note box below.|
|3/8/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||The following information was added to question 153: It should be noted for cord blood unit transplants that almost all units are screened, or the infant is screened, for potentially transplantable genetic diseases. This may be documented as a ‘hemoglobin screen,’ which evaluates for sickle cell and/or thalassemia, both of which are hemoglobinopathies.|
|3/8/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||Instructions on how to report the date of product analysis, depending on if the the product was analyzed multiple times and examples 1 – 3 were added to question 42.|
|3/8/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||Added the following statement to question 41: The At Infusion timepoint should include values reflective of the product infused regardless of when the analysis occurred. Since all products are analyzed prior to cryopreservation, the At Infusion timepoint would be applicable for these cell counts. Depending on the product type and your center’s practice, viability may be assessed closer to the time of infusion.|
|3/8/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||Example 1 added to questions 2-3: Example 1: The donor was mobilized with Granix (tbo-Filgrastim) prior to the start of collection. Since this is a biologic medical product that is highly similar to Neupogen, this would be captured under G-CSF.|
|12/22/2020||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Modify|| The blue note box in question 31 was updated: In the new revision of the HCT Infusion (2006) Form, product processing and manipulation have been separated into two categories for reporting purposes.
Product Processing: Captures changes made to the original product that does not affect the physical properties of the product
Product Manipulation: Captures changes made to the original product affecting the physical properties of the product
|8/21/2020||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Modify|| Updated the following note box (above Q159) to clarify the intent of Q159-170:
The following questions (
|6/3/2020||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Added||Provided clarification to questions 1, 4, and 5 that these questions are only enabled for PBSC and bone marrow products from non-NMDP donors.|
|5/19/2020||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Modify||For question 13, specified that a constant temperature is usually found in cord blood shipping containers.|
|4/6/2020||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Modify||In section Q144-170: Donor/Infant Demographic Information, moved question 147 to question 159.|
|3/23/2020||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Modify||Added guidance to questions 46 – 47, 58-59, 64-65, 70-71, and 76-77 regarding scenarios where center’s laboratory assay only measures viable cells.|
|2/27/2020||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Modify|| Updated the text for questions 163-165 as indicated below (removed text is struck out and added text is in red):
|1/24/2020||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Modify||Version 4 of the 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion section of the Forms Instruction Manual released. Version 4 corresponds to revision 5 of the Form 2006.|
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