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Infection & Miscellaneous Manuals

Infection & Miscellaneous Manuals

These manuals provide explanatory information for forms that are less routinely completed. 2046 / 2146 Fungal Infection 2047 / 2147: Hepatitis Serology 2149: Respiratory Virus Post-Infusion Data 2150: Viral Infection Diagnosis and Treatment Form 2540: Tepadina®…

Q35-38: Infection

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q35-38: Infection

Question 35: Did the recipient have a history of clinically significant fungal infection (documented or suspected) in the 6 months prior to the start of the preparative regimen? Fungal infections play a major role in the clinical outcome of a transplant recipient. The…

Q428-440: Infection

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q428-440: Infection

Infections occur frequently in transplant patients. Questions 428-440 are intended to capture detailed information on clinically significant infections diagnosed during the reporting period. A single infection may be found on multiple cultures or at multiple sites.…

Q171-175: Infection

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q171-175: Infection

Infections occur frequently in recipients of cellular therapy or transplant. Questions 171-175 are intended to capture detailed information on clinically significant infections diagnosed during the reporting period. A single infection may be found on multiple…

Q50-51: Infection

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q50-51: Infection

*Diagnosis of COVID-19 after the start of the preparative regimen: Any COVID-19 infections diagnosed after the start of the preparative regimen should be reported in questions 50 – 51 on the Post-TED (2450) form. An associated Respiratory Virus Post-Infusion Data…

Q1-10: Infection Diagnosis

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data » Q1-10: Infection Diagnosis

Question 1: Date of Infection Diagnosis The reported date of COVID-19 (SARS-CoV-2) diagnosis must match the diagnosis date reported on the corresponding follow-up form. Report the date the sample was collected for the first test which confirmed the diagnosis. The…

Q1-31: Infection Episode

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q1-31: Infection Episode

Question 1: Organism This field is auto-populated to match the virus reported on the Post-HCT Follow-Up Data Form (Form 2100). Review the value to ensure it is accurate. A Viral Infection Diagnostic Form will come due for each CMV, EBV, ADV, HHV-6, and BK virus…

Q1-25: Infection Episode

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data » Q1-25: Infection Episode

Question 1: Organism This field is auto-populated to match the fungus reported on the Post-HCT Follow-Up Form (Form 2100). Review the value to ensure it is accurate. A Fungal Infection Post-Infusion Data Form will come due for each applicable infection reported on the…

2046 / 2146: Fungal Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection

Fungal infections are significant opportunistic infections affecting transplant recipients. Because these infections are quite serious, it is important to collect additional information on them. Fungal infection specific forms (Form 2046 and 2146) collect more…

Q407-427: Infection Prophylaxis

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q407-427: Infection Prophylaxis

*Infection Prophylaxis It is important to look at the Medication Administration Record (MAR) throughout the entire reporting period to ensure medications are not missed. Also, the use of some infection prophylactic drugs may not start immediately post-HCT (example:…

Q1-25: Infection Episode

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2046: Fungal Infection Pre-Infusion Data » Q1-25: Infection Episode

Question 1: Organism This field is auto-populated to match the fungus reported on the Baseline Form (Form 2000). Review the value to ensure it is accurate. A Fungal Infection Pre-Infusion Data Form will come due for each applicable infection reported on the Baseline…

Q26-31: Treatment of Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2046: Fungal Infection Pre-Infusion Data » Q26-31: Treatment of Infection

Question 26: Did the recipient receive any therapy between 7 days prior to the date of infection diagnosis and the date of infusion? Report “Yes” if the recipient received any antifungal treatment from seven days prior to the date of diagnosis (refer to question…

Q43-49: Treatment of Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data » Q43-49: Treatment of Infection

Question 43: Did the recipient receive any therapy between 7 days prior to the date of infection diagnosis and the date of contact for this reporting period? Report “Yes” if the recipient received any antifungal treatment from seven days prior to the date of…

2046: Fungal Infection Pre-Infusion Data

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2046: Fungal Infection Pre-Infusion Data

Fungal infections are significant opportunistic infections affecting transplant patients. Because these infections are quite serious, it is important to collect additional information on them. The Fungal Infection Pre-Infusion Data Form (Form 2046) captures…

2146: Fungal Infection Post-Infusion Data

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data

The Fungal Infection Post-Infusion Data Form (Form 2146) captures information regarding the diagnosis, treatment, and response to treatment of fungal infections diagnosed after receiving a HCT or cellular therapy. This form must be completed when one of the fungal…

2150: Viral Infection Diagnosis and Treatment Form

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form

The CMV / EBV / ADV / HHV-6 / BK Viral Infection Diagnostic Form captures information regarding the diagnosis, treatment, and status of the following infections: Cytomegalovirus (CMV) Epstein-Barr Virus (EBV) Adenovirus (ADV) Human Herpes Virus 6 (HHV-6) BK Virus…

Q26-42: Hematologic Findings at Diagnosis of Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data » Q26-42: Hematologic Findings at Diagnosis of Infection

Question 26-36: Complete Blood Count Report the date of the complete blood count (CBC) performed closest to the date of diagnosis of the fungal infection being reported on this form. The CBC must have been performed within seven days of the date of diagnosis.. For…

Q32-50: Hematologic Findings at Diagnosis of Infection

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q32-50: Hematologic Findings at Diagnosis of Infection

Question 32-50: Provide values closest to the date of diagnosis of the infection (±7 days) All values reported in questions 32-50 must reflect testing performed within seven days of the date of diagnosis (question two). If multiple tests were performed during this…

Q11-24: Hematologic Findings at Diagnosis of Infection

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data » Q11-24: Hematologic Findings at Diagnosis of Infection

Question 11-21: Complete Blood Count For the initial form, report the date and values of the complete blood count (CBC) performed closest to the date of diagnosis, within seven days of the date of diagnosis of the respiratory viral infection being reported on this…

Q10-17: Serological Evidence of Hepatitis Exposure / Infection – Donor

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q10-17: Serological Evidence of Hepatitis Exposure / Infection – Donor

Complete questions 10-17 for allogeneic transplants only; if donor information is unknown, leave the data field blank. These data fields should be used to report new information available for donors that developed hepatitis post-transplant. If this is the first…

Q1-9: Serological Evidence of Hepatitis Exposure / Infection – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q1-9: Serological Evidence of Hepatitis Exposure / Infection – Recipient

Question 1: Hepatitis B core antibody (HBcAb) The total hepatitis B core antibody refers to both IgG and IgM antibodies produced by the body in response to the presentation of the core antigen by liver cells. Since core antigen is present only in infected liver cells…

Q24-32: History of Epstein Barr Virus (EBV) Infection

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q24-32: History of Epstein Barr Virus (EBV) Infection

Question 24: Is there a history of EBV infection? Epstein-Barr virus (EBV) is one of the human herpes viruses (Herpesviridae family). It is the virus that causes infectious mononucleosis, commonly referred to as “mono.” XLP may present as an exaggerated immune…

Q27-34: Serological Evidence of Prior Hepatitis Exposure / Infection – Donor

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q27-34: Serological Evidence of Prior Hepatitis Exposure / Infection – Donor

Complete questions 27-34 for allogeneic transplants only; if donor information is unknown, leave the data field(s) blank. Complete all data fields for which relevant donor information is documented and available to the CIBMTR center completing the form. Question 27:…

Q1-6: Serological Evidence of Prior Hepatitis Exposure / Infection – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q1-6: Serological Evidence of Prior Hepatitis Exposure / Infection – Recipient

Question 1: Specify and/or confirm previous Hepatitis B surface antigen (HBsAg) testing performed and reported on the Form 2000 – Recipient Baseline Data The hepatitis B surface antigen is a protein expressed on the surface of the hepatitis B virus. Its presence in…

Q77: Infection Status at the Time of Evaluation for this Reporting Period

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q77: Infection Status at the Time of Evaluation for this Reporting Period

Question 77: What was the infection status at the time of evaluation for this reporting period? Report the status of the viral infection on the date of contact for this reporting period (refer to the corresponding follow-up form) based on the primary care provider’s…

Q59-74: History of Infection at Any Time Prior to the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q59-74: History of Infection at Any Time Prior to the Preparative Regimen

Specify documented infection(s) associated with HLH. Question 59: Was an infection documented? Indicate if an infection associated with HLH was present at any time prior to the start of the preparative regimen. If the recipient developed an infection associated with…

Q25-41: Therapy

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data » Q25-41: Therapy

Question 25 : Did the recipient receive any therapy? For the initial form, report “Yes” if the recipient received therapy to treat the respiratory virus infection from 7 days prior to and up to 14 days after the diagnosis date reported in question 1. For the…

Q501-505: Histocytic Disorders

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q501-505: Histocytic Disorders

Questions 501-502: Specify the histiocytic disorder classification: Indicate the histiocytic disorder disease classification at diagnosis. If the subtype is not listed, report as “other histiocytic disorder” and specify the reported disease in question 502. If a…

Q51-76: Therapy

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q51-76: Therapy

Question 51: Did the recipient receive any therapy between 7 days prior to the date of infection diagnosis and the date of contact for this reporting period? Report “Yes” if the recipient received any antiviral medication between seven days prior to the date of…

Q488-495: Disorders of Immune System

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q488-495: Disorders of Immune System

Questions 488-491: Specify disorder of immune system classification: Indicate the disorder of the immune system’s disease classification at diagnosis. If the subtype is not listed, report as “other SCID”, “other immunodeficiency” or “other pigmentary…

Cause of Death Codes

Comprehensive Baseline & Follow-up Manuals » 2900: Recipient Death » Cause of Death Codes

Recurrence / persistence / progression of disease for which the HCT or cellular therapy was performed. If the disease is present at death, but not the underlying cause of death, “Recurrence/persistence/progression of disease for which the HCT or cellular therapy was…

Q51-115: Clinical Features Assessed Between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT » Q51-115: Clinical Features Assessed Between Diagnosis and the Start of the Preparative Regimen

Infection Identified between Diagnosis and the Start of the Preparative Regimen Specify the presence of all clinically significant infections identified between diagnosis and the start of the preparative regimen. Only report an organism once, even if it was identified…

2034/2134: X-Linked Lymphoproliferative Sydrome (XLP)

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP)

X-linked lymphoproliferative syndrome, also known as XLP or Duncan’s syndrome, is a rare inherited immunodeficiency. It is characterized by severe immune dysregulation, which generally manifests as an exaggerated immune response to infection. XLP belongs to the group…

2047 / 2147: Hepatitis Serology

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology

Hepatitis is a general term referring to non-specific inflammation of the liver, which can be caused by multiple conditions, including viral infection. This form is intended to capture information regarding two forms of viral hepatitis infections, Hepatitis B and…

2147: Hepatitis Serology Post-HCT

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT

The Hepatitis Serology Post-HCT Data, Form 2147, will come due when the following IDMs are reported as “positive” on the Form 2000, Recipient Baseline Data: Hepatitis B surface antigen Hepatitis B core antibody Hepatitis B DNA Hepatitis C antibody Hepatitis C…

Q2-29: Infectious Disease Markers

Comprehensive Baseline & Follow-up Manuals » 2004: Infectious Disease Markers » Q2-29: Infectious Disease Markers

Report the final test results. Final test results could refer to either the initial screening test or the confirmatory test. If a screening test is negative, a confirmatory test might not be done. In this case, use the screening test as the final test result. However,…

Q95-166: Post-HCT Treatment for Immune Deficiency

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT » Q95-166: Post-HCT Treatment for Immune Deficiency

Question 95: Was treatment given (since the date of last report)? The questions below regarding prophylactic anti-infection and immunosuppressant drugs, refer to supportive therapy used to treat or prevent the sequelae (or condition as a result of the disease) such as…

Q44-94: Clinical Features Assessed Post-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT » Q44-94: Clinical Features Assessed Post-HCT

Infections Identified Post-HCT Specify the presence of all clinically significant infections identified since the date of the last report. Only report an organism once, even if it was identified at the same site in subsequent infections. Question 44:…

2010/2110: Acute Myelogenous Leukemia (AML)

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML)

Acute Myelogenous Leukemia (AML) is a cancer of the white blood cells. It is characterized by the rapid proliferation of abnormal, immature myelocytes, known as myeloblasts, in the bone marrow. This accumulation of blasts in the marrow prevents the formation of healthy…

Q1-4: Recipient Death Data

Comprehensive Baseline & Follow-up Manuals » 2900: Recipient Death » Q1-4: Recipient Death Data

Question 1: Date of Death: Report the date the recipient died. Confirm that the date matches the last date of actual contact reported on the Form 2100 or Form 4100. If the death occurred at an outside location and records of death are not available, the dictated date…

2039/2139: Hemophagocytic Lymphohistiocytosis (HLH)

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH)

Hemophagocytic Lymphohistiocytosis (HLH) is a rare condition characterized by immune dysregulation, which generally manifests as an exaggerated immune response to a trigger (such as infection). Based on genetics and family history, the disease is divided into…

2047: Hepatitis Serology Pre-HCT

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT

The Hepatitis Serology Pre-HCT Data, Form 2047, will come due when any of the following IDMs are reported as “positive” on the Form 2000, Recipient Baseline Data: Hepatitis B surface antigen Hepatitis B core antibody Hepatitis B DNA Hepatitis C…

2028/2128: Aplastic Anemia

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia

Aplastic Anemia is a disease in which the bone marrow does not produce enough red blood cells, white blood cells, or platelets for the body. The disease can be idiopathic, or can be caused by environmental exposure, pharmaceutical or drug exposure, or exposure to viral…

Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen

Question 52: Was HLH present? HLH is an abnormal proliferation of macrophages and histiocytes that leads to the phagocytosis of healthy circulating blood cells. Indicate if the patient developed HLH at any time after diagnosis but prior to the start of the preparative…

2011/2111: Acute Lymphoblastic Leukemia (ALL)

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL)

Acute Lymphoblastic Leukemia (ALL) is a cancer of the white blood cells. It is characterized by the rapid proliferation of abnormal, immature lymphocytes, or lymphoblasts, in the bone marrow. This accumulation of blasts in the marrow prevents the formation of healthy…

Q103-113: Comorbid Conditions

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q103-113: Comorbid Conditions

*Diagnosis of COVD-19 after the start of the lymphodepleting therapy: Questions 103 – 105 are intended to capture COVID-19 (SARS-CoV-2) infections diagnosed prior to the start of the lymphodepleting therapy / infusion. If a COVID-19 infection is diagnosed after the…

Q23-34: Hematologic Findings Prior to the Preparative Regimen (Conditioning)

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q23-34: Hematologic Findings Prior to the Preparative Regimen (Conditioning)

*Infusion Without a Preparative Regimen Complete questions 23-34 based on the most recent testing prior to infusion if no preparative regimen was given. Question 23: Date CBC tested: (testing within 30 days of start of preparative regimen) These questions are…

Q9-11: Best Response to Cellular Therapy

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q9-11: Best Response to Cellular Therapy

This section may not fit perfectly to all possible indications for cellular therapy. Please select the response that is most applicable to the indication for treatment. *If the primary disease reported is Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic…

Q23-33: Current Hematologic Findings

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q23-33: Current Hematologic Findings

!Questions 23-33 can only be completed on the 100 day, 6 month, 1 year, and 2 year follow-up forms. These questions will be disabled for all subsequent reporting periods. Question 23: Date of most recent complete blood count (CBC) sample drawn: These questions are…

Q89-99: Hematologic Findings Prior to Lymphodepleting Therapy

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q89-99: Hematologic Findings Prior to Lymphodepleting Therapy

Question 89: Date complete blood count (CBC) sample drawn: These questions are intended to determine the clinical status of the recipient prior to the start of lymphodepleting therapy for cellular therapy. Testing may be performed multiple times within the…

2149: Respiratory Virus Post-Infusion Data

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data

In an effort to collect data on the impact of the COVID-19 (SARS-CoV-2) pandemic on our transplant and cellular therapy recipients, CIBMTR released the Respiratory Virus Post-Infusion Data (2149) Form. This form captures information regarding the diagnosis, treatment,…

Q87-115: Comorbid Conditions

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q87-115: Comorbid Conditions

*Diagnosis of COVID-19 after the start of the preparative regimen: Questions 87 – 89 are intended to capture COVID-19 (SARS-CoV-2) infections diagnosed prior to the start of the preparative regimen / infusion. If a COVID-19 infection is diagnosed after the start of…

Q116-191: Pre-HCT Therapy for Immune Deficiency

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT » Q116-191: Pre-HCT Therapy for Immune Deficiency

Question 116: Was treatment given (between diagnosis and prior to the preparative regimen)? Since immune deficiencies are non-malignant diseases caused by genetic mutations, hematopoietic stem cell transplant is the main curative treatment at this time. Other…

2004: Infectious Disease Markers

Comprehensive Baseline & Follow-up Manuals » 2004: Infectious Disease Markers

Form 2004 will come due in the following instances: Non-NMDP unrelated donor (TED or CRF track) Non-NMDP unrelated cord blood (TED or CRF track) Related cord blood (TED or CRF track) HLA-identical sibling (CRF track or when consented for “Research Sample…

Q42-130:Clinical Features Assessed between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2033: WAS Pre-HCT » Q42-130:Clinical Features Assessed between Diagnosis and the Start of the Preparative Regimen

Infections identified between Diagnosis and the Start of the Preparative Regimen Specify the presence of all clinically significant infections identified between diagnosis and the start of the preparative regimen. For the purposes of this form, clinically significant…

Q1-23: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q1-23: Disease Assessment at Diagnosis

Question 1: Is this recipient a registered participant in the United States Immunodeficiency Network (USIDNET)? The United Stated Immunodeficiency Network (USIDNET) is a research consortium studying primary immune deficiencies. They maintain a registry of primary…

2039: HLH Pre-HCT

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT

The Hemophagocytic Lymphohistiocytosis Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures HLH-specific Pre-HCT data such as the disease assessment, clinical and laboratory features at diagnosis, history of infection, pre-transplant therapy,…

2013/2113: Chronic Lymphocytic Leukemia (CLL)

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL)

Chronic lymphocytic leukemia (CLL) is a cancer of the B lymphocytes. B lymphocytes are white blood cells that develop in the bone marrow and circulate throughout the blood to fight infection. In CLL, lymphocytes with damaged DNA proliferate within the blood,…

Appendix O: Cellular Therapy Critical Fields

Appendices » Appendix O: Cellular Therapy Critical Fields

The following list of data fields have been identified as being critical to accurate outcome analyses. These fields are audited for each recipient selected for audit. The table below is a summary of many of the critical data points grouped by data field type. Critical…

2012/2112: Chronic Myeloid Leukemia (CML)

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML)

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by the increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

Q58-77: Indication for Cellular Therapy

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q58-77: Indication for Cellular Therapy

Question 58: What was the primary indication for performing treatment with cellular therapy? From the list provided, select the primary indication for which the recipient is receiving the cellular therapy. If the indication is in the list below and the cell therapy…

Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Question 7: Did the recipient receive therapy for hepatitis prior to HCT? Hepatitis antiviral therapy is intended to prevent progression of the disease and minimize sequelae of infection. The National Institutes of Health (NIH) in the United States recommends…

Q234-288: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q234-288: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 234-288 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if not preparative regimen was given). Do not report testing performed during a line of therapy reported in questions 167-223. If…

Q213-254: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q213-254: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 213: Date CBC with differential drawn Report the date of the CBC with differential was drawn at the last evaluation prior to the start of the preparative regimen / infusion and continue with question 214. If multiple assessments were performed, report the…

2018 Manual Updates

Getting Started » Getting Started » 2018 Manual Updates

December 2018 November 2018 October 2018 September 2018 August 2018 July 2018 June 2018 May 2018 April 2018 March 2018 February 2018 January 2018 Updates made during the current calendar year are included below. For updates prior to 2018, click on the subtopic…

Q83-88: Data from Post-HSCT Follow-Up Form (2100)

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q83-88: Data from Post-HSCT Follow-Up Form (2100)

Questions 83-88 refer to data reported on form 2100, Q441-615, please ensure data reported here matches with form 2100. Questions 83-85: In the transplant physician’s judgment, were any of the disorders / impairments reported on the form 2100 a direct result of…

4100: Cellular Therapy Essential Data Follow-Up

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up

This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT “DCI / DLI” infusions. For recipients of hematopoietic cellular transplants, complete the appropriate HCT follow-up form. The Post-Cellular Therapy Essential Data…

Appendix B: Glossary of Terms

Appendices » Appendix B: Glossary of Terms

General Terms absolute neutrophil count (ANC) Neutrophils are a type of white blood cell that helps protect the body from infection. The number of neutrophils in a recipient’s blood is used to track recovery after chemotherapy or HSCT. In some types of HSCT, the…

Q18-37: Antiviral Therapy for Hepatitis

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q18-37: Antiviral Therapy for Hepatitis

This section is related to antiviral therapy given to the recipient. Question 18: Was therapy given for hepatitis since the date of the last report (or, if this is the first post-HCT report, since diagnosis)? Hepatitis antiviral therapy is intended to prevent…

Q45-47: Liver Toxicity Prophylaxis

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q45-47: Liver Toxicity Prophylaxis

!Liver Toxicity Prophylaxis Questions 45-47 can only be completed on the 100 day and 6 month follow-up forms. These questions will be skipped for all subsequent reporting periods. Question 45: Was specific therapy used to prevent liver toxicity? Liver toxicities in…

Q35-54: History of Antiviral Therapy for Hepatitis – Donor

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q35-54: History of Antiviral Therapy for Hepatitis – Donor

Complete questions 35-54 for allogeneic transplants only; if donor information is unknown, leave the data field blank. Complete all data fields for which relevant donor information is documented and available to the CIBMTR center completing the form. Question 35: Did…

2000: Recipient Baseline

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline

A transplant center designated as a Comprehensive Report Form center will submit data on the Pre-TED Form, followed by either the Post-TED Form or the Comprehensive Report Forms. The type of follow-up form used for a specific recipient is determined by the CIBMTR’s…

Getting Started

Getting Started » Getting Started

Welcome to the CIBMTR Forms Instruction Manual. The Table of Contents on the left side of the screen is for navigational purposes; if you are on a mobile device you may find the Table on Contents on the top of the page. General Instructions provides useful general…

Q64-88: Immune Reconstitution

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q64-88: Immune Reconstitution

!Questions 64-88 can only be completed on the 100 day, 6 month, 1 year, and 2 year follow-up forms. These questions will be skipped for all subsequent reporting periods. These questions are intended to determine whether the recipient recovered their immune function…

2100: Post-HCT Follow-Up

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up

A transplant center designated as a Comprehensive Report Form center will submit data on the Pre-TED and Pre-TED Disease Classification Forms, followed by either the Post-TED Form or the Comprehensive Report Forms. The type of follow-up forms required for a specific…

Q20-30: Current Assessment of Immunologic Fuction Post-HCT

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT » Q20-30: Current Assessment of Immunologic Fuction Post-HCT

Question 20: Did the recipient receive supplemental intravenous immunoglobulins (IVIG)? IVIG is a product made from pooled human plasma that primarily contains IgG. It is used to provide immune-deficient recipients with antibody function to prevent infection.…

2034: XLP Pre-HCT

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT

The X-Linked Lymphoproliferative Syndrome Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures XLP-specific pre-HCT data such as: the recipient’s clinical and genetic findings at the time of diagnosis and prior to the start of the…

Q4-56: Pre-Collection Therapy Given to Enhance Product Collection

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data » Q4-56: Pre-Collection Therapy Given to Enhance Product Collection

Question 4: Was pre-collection chemotherapy given to enhance product collection? Report “Yes” and go to question five if there was pre-collection chemotherapy given to enhance product collection. If “No”, go to question 12. Question 5: Specify where…

Appendix J: Reporting Comorbidities

Appendices » Appendix J: Reporting Comorbidities

CIBMTR collects comorbidities data based on criteria from the Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI), which was developed and validated by investigators at the Fred Hutchinson Cancer Research Center in Seattle, Washington. The HCT-CI was…

Q211-252: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q211-252: Disease Status at the Time of Evaluation for this Reporting Period

For questions 211-252, report values obtained at the last evaluation for this reporting period. If testing is performed multiple times during the reporting period, report the values obtained at the last evaluation in the reporting period. Questions 211-212: Serum…

2031: ID Pre-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT

The Immune Deficiency Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures ID-specific pre-HCT data such as: disease assessment at diagnosis, laboratory studies at diagnosis, clinical features assessed between diagnosis and the start of the…

2112: CML Post-Infusion Data

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by the increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

Q441-615: Organ Function

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q441-615: Organ Function

Links within section: Pulmonary Function Liver Toxicity Prophylaxis Liver Function Thrombotic Microangiopathy Other Organ Impairment / Disorder Pulmonary Function *Bacterial, Viral, and Fungal Pneumonia Report pneumonia due to infection in the Infection section…

2900: Recipient Death

Comprehensive Baseline & Follow-up Manuals » 2900: Recipient Death

The Recipient Death Data (Form 2900) captures cause of death data fields for recipients on the Comprehensive Report Form follow-up track and the cellular therapy track. The leading cause of post-infusion mortality is persistent, recurrent, or relapsed primary disease.…

2131: ID Post-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT

The Immune Deficiency Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures ID-specific post-HCT data such as: laboratory studies post-HCT, clinical features assessed post-HCT, Post-HCT treatment, and status of hematologic engraftment. This…

Q1-6: Survival

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q1-6: Survival

The date of actual contact with the recipient to determine medical status for this follow-up report is based on a medical evaluation conducted by a clinician with responsibility for the recipient’s care. Report the date of the medical evaluation performed closest to…

CML Response Criteria

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » CML Response Criteria

*For recipients with CML, the disease status may be tracked by molecular and cytogenetic (karyotype and/or FISH) assessments. However, for reporting purposes, the disease status should only be reported based off of clinical / hematologic assessments. For example, a…

2017 Manual Updates

Getting Started » Getting Started » 2017 Manual Updates

December 2017 November 2017 October 2017 September 2017 August 2017 July 2017 June 2017 May 2017 April 2017 March 2017 February 2017 January 2017 !Hyperlinks Please note, hyperlinks on this page will not work for any manual sections which have been retired and / or…

Q83-86: Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q83-86: Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

Question 83: What scale was used to determine the recipient’s functional status? The CIBMTR uses the Karnofsky / Lansky scale to determine the functional status of the recipient immediately prior to the start of the preparative regimen. The Karnofsky Scale is…

Appendix M: HCT Critical Data Fields

Appendices » Appendix M: HCT Critical Data Fields

The following list of data fields have been identified as being critical to accurate outcome analyses. These fields are audited for each recipient selected for audit. The table below is a summary of many of the critical data points grouped by data field type. Critical…

Q64-99: Post-HCT / Post-Infusion Planned Therapy

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q64-99: Post-HCT / Post-Infusion Planned Therapy

Question 64: Was therapy given since the date of last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy.) Indicate if the recipient received treatment post-Infusion for reasons other than relapse,…

Q33-51: Assessment of Immunologic Function at Diagnosis

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q33-51: Assessment of Immunologic Function at Diagnosis

Report findings from immune function studies at the time of diagnosis; if multiple studies were performed, report the initial values. Question 33: NK cell function Natural killer (NK) cells are cytotoxic lymphocytes implicated in viral response and tumor…

Q168-178: Chronic Myelogenous Leukemia

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q168-178: Chronic Myelogenous Leukemia

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

Q27-42: Post-HCT / Post-Infusion Planned Therapy

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q27-42: Post-HCT / Post-Infusion Planned Therapy

Question 27: Was therapy given since the date of last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy.) Indicate if the recipient received treatment post-Infusion for reasons other than relapse,…

Q41-54: DIPSS Prognosis Score

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q41-54: DIPSS Prognosis Score

Question 41: Specify the maximum DIPSS score the patient ever achieved The DIPSS score is based on five variables including recipient’s age, white blood count (WBC), hemoglobin, peripheral blood blasts and constitutional symptoms. Each variable is assigned a point…

Q48-81: IPSS-R Prognosis Score

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q48-81: IPSS-R Prognosis Score

Question 48: Specify the maximum IPSS-R score the patient ever achieved: The revised International Prognostic Scoring System (IPSS), known as the IPSS-R, is based on five variables including blasts in the bone marrow, cytogenetic findings, hemoglobin, absolute…

2012: CML Pre-Infusion Data

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by the increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

MDS Response Criteria

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » MDS Response Criteria

MDS Response Criteria MDS Response Criteria Complete Remission (CR) Requires all of the following maintained for a minimum of four weeks. When reporting the CR achievement date, report the first date when CR was achieved (not the four week date in which CR was…

2020 Manual Updates

Getting Started » Getting Started » 2020 Manual Updates

January 2020 February 2020 March 2020 April 2020 May 2020 June 2020 July 2020 August 2020 October 2020 December 2020 Updates made during the current calendar year are included below. For updates prior to 2020, click on the subtopic corresponding to the year of…

Q1-19: Disease Assessment Since the Date of Last Report

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT » Q1-19: Disease Assessment Since the Date of Last Report

Question 1: Did the recipient have lymphoma at the time of HCT? XLP is associated with a higher incidence of lymphoma, which may be secondary to EBV infection; however, not all lymphomas in the setting of XLP exhibit EBV clonality. There is speculation that lymphoma…