Q107-119: Comorbid Conditions

*HCT-CI
Were there any co-existing diseases or organ impairment present according to the HCT comorbidity index (HCT-CI)? are applicable for malignant hematologic disorders and solid tumor indications ONLY

Question 107: Prior viral exposure/infection (check all that apply)

Indicate if the recipient was positive for any of the viral exposure or infections listed below. Do not select the viral exposure or infection if the test was performed and the results were negative. If the test results are equivocal, only select the applicable result if the physician has noted it to be a concern.

If testing for evidence of prior viral exposure / infection was not performed, select Not done.

Select Not applicable if testing for evidence of prior viral exposure / infection was performed and all the results were negative.

*Serologic Tests
Serologic tests (i.e. antibody or antigen tests) should be completed during the pre-infusion work-up phase, or approximately one month prior to the start of systemic therapy (e.g., lymphodepleting therapy

HTLV1 antibody: Human T-Lymphotropic virus I/II (HTLV I/II) is a retrovirus in the same class as HIV. HTLV I/II is associated with certain leukemias and lymphomas, as well as demyelinating diseases such as multiple sclerosis.

Anti-EBV (Epstein-Barr virus antibody): Epstein-Barr Virus (EBV) is a common virus of the herpes family. It can cause infectious mononucleosis, but in most cases is asymptomatic. EBV establishes a lifelong dormant infection in some cells of the body’s immune system. Serious post-transplant complications related to EBV include EBV viremia (reactivation) and post-transplant lymphoproliferative disease (PTLD). EBV early antigen antibody should be reported as a positive result here.

Cytomegalovirus (CMV): CMV is a common virus that infects 50-80% of adults worldwide and is transmitted from person to person through bodily fluids. The virus that causes CMV is part of the herpes virus family and, like other herpes viruses, CMV may be dormant for a period of time before the virus is activated in the host. CMV infections are usually harmless in a healthy immune system and typically cause only mild symptoms, if any. However, if a person’s immune system is seriously weakened (as in an immunosuppressed stem cell recipient) the virus can have serious consequences such as pneumonia, liver failure, and even death.

Hepatitis B surface antibody: Hepatitis B is caused by the hepatitis B virus (HBV). Infection with this virus can cause scarring of the liver, liver failure, liver cancer, and even death. Hepatitis B is spread through infected blood and other body fluids. Acute hepatitis B infection does not usually require treatment because most adults clear the infection. Treatment of chronic infection may be necessary to reduce the risk of cirrhosis and liver cancer.

The hepatitis B surface antibody test reveals the presence of hepatitis B antibodies, indicating previous exposure to HBV (or successful vaccination), but the virus is no longer present, and the person cannot pass on the virus.

Anti-HBc (hepatitis B core antibody): The enzyme-linked immunosorbent assay (ELISA) technique tests for the antibody directed against the hepatitis B virus core proteins. The hepatitis B core antibody test can indicate previous HBV infection. Currently there is no licensed confirmatory test for Anti-HBc. If the screening test is reactive, a second Anti-HBc test is performed using a different manufacturer’s test kit.

HBsAg (hepatitis B surface antigen): The ELISA or enzyme immunoassay (EIA) techniques test for the presence of proteins produced by the hepatitis B virus. Confirmatory testing is done using a neutralization test. The first marker appears approximately three weeks following infection, and disappears approximately six months later.

Hepatitis B – NAAT: Nucleic acid testing (NAAT) is a combination PCR test that detects the presence of viral genes rather than antigens or antibodies. This test allows earlier detection and provides more sensitivity than previously used tests.

Anti-HCV (hepatitis C antibody): Hepatitis C is a serious infection caused by the hepatitis C virus (HCV), which attacks the liver and may cause life-long infection. HCV is considered the most serious hepatitis infection because of its significant long-term health consequences. The infection is often asymptomatic, but once established, chronic infection can cause inflammation of the liver. This condition can progress to fibrosis and cirrhosis. In some cases, those with cirrhosis will go on to develop liver failure or liver cancer. Presence of the antibody in the blood represents exposure to HCV, which is most often spread by blood-to-blood contact. No vaccine against HCV is available.

The ELISA technique tests for antibodies to the HCV. Confirmatory testing is done using the recombinant immunoblot assay (RIBA) test. These tests can determine past exposure to HCV, but not current viral load.

Hepatitis C – NAAT: Nucleic acid testing (NAAT) is a combination PCR test that detects the presence of viral genes (HCV RNA) rather than antigens or antibodies. This test allows earlier detection and provides more sensitivity than previously used tests.

HIV antibody: HIV infection is caused by exposure to one of two viruses: HIV-1 or HIV-2. HIV-2 is less virulent and has a longer incubation period than HIV-1. Both types of HIV progressively destroy lymphocytes, which are an important part of the body’s immune defense. HIV can lead to acquired immunodeficiency syndrome (AIDS), a condition in which the immune system begins to fail, leading to life- threatening opportunistic infections. Infection with HIV occurs by the transfer of bodily fluids and is present as both free virus particles and virus within infected immune cells.

HIV antibody testing is done using combination ELISA which detects antibodies to the HIV-1 and HIV-2 viruses. HIV-1 is confirmed by Western Blot, which detects specific proteins using gel electrophoresis. There is currently no licensed confirmatory test for HIV-2. If the screening test is reactive, HIV-2 is confirmed by specific ELISA.

The results of HIV assessments are often kept in confidence and may not be reportable to anyone other than the patient and their physician. If HIV testing was done, but the results are not available, do not select this option.

If the result is “positive,” also complete the Human Immunodeficiency Virus Pre-Infusion (2048) form.

HIV – NAAT: Nucleic acid testing (NAAT) is a PCR test that detects the presence of viral genes rather than antigens or antibodies. This test allows earlier detection and provides more sensitivity than previously used tests.

The results of HIV assessments are often kept in confidence and may not be reportable to anyone other than the patient and their physician. If HIV testing was done, but the results are not available, do not select this option.

If the result is “positive,” also complete the Human Immunodeficiency Virus Pre-Infusion (2048) form.

Toxoplasmosis antibody: Toxoplasmosis is caused by the parasitic protozoan Toxoplasma gondii, or T. gondii. Toxoplasmosis is spread through ingestion of contaminated food or water or contact with infected cat feces. T. gondii infection is usually subclinical in healthy individuals, but infection can cause serious symptoms in pregnant women and immunocompromised individuals. Chronic, dormant T. gondii infection may follow initial exposure, and can then reoccur. Severe toxoplasmosis can affect the brain, eyes, and other organs and can cause permanent organ damage.

Testing for antibodies to T. gondii is generally done by enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay (CIA). These immunoassays can be used to detect IgM and / or IgG antibodies to T. gondii. The presence of IgM antibodies indicates a recent or current infection, usually within the past four to six months. The presence of IgG antibodies indicates a previous infection and confers a long-term immune response to the virus. Results may be expressed as quantified antibody titer; in this case, the laboratory or test kit manufacturer will provide reference ranges to determine if the result is considered positive, indeterminate, or negative. Confirmatory testing is available to verify a positive serological result; this is done by Toxoplasma Serological Profile (TSP), which is a panel of multiple antibody ELISAs and agglutination testing.

*Prior Malignancies
Report all prior malignancies diagnosed prior to the infusion, regardless of if therapy was administered.

Questions 108: Did the recipient have a prior malignancy?

Specify if the recipient has any history of a prior malignancy (treated or untreated) preceding this infusion.

Report any solid tumor(s), hematologic malignancy(ies), and / or skin malignancy(ies) that have been diagnosed at any time point prior to the infusion. A history of any benign tumor(s) should not be reported.

If the recipient is receiving an infusion for a disease that transformed from one disease to another (i.e., MDS to AML, CLL to NHL), the original malignancy should not be reported as a prior malignancy. Details regarding disease transformation are captured on the Disease Classification (2402) Form.

If it is unclear if there was a prior malignancy, seek clinician clarification.

Questions 109-112: Specify prior malignancy (check all that apply)

Specify the recipient’s prior malignancy(ies) and indicate if the prior malignancy was treated. Select all that apply.

If Other hematologic malignancy is selected, specify the prior hematologic malignancy.

If Other solid tumor is selected, specify the prior solid tumor.

*Comorbidities
Prior to answering Were there any co-existing diseases or organ impairment present according to the HCT comorbidity index (HCT-CI) question, review the list of co-existing disease(s) and/or organ impairments listed in Appendix J: Reporting Comorbidities.

Question 113: Were there any co-existing diseases or organ impairment present according to the HCT comorbidity index (HCT-CI)?

*Comorbidity Timeframe Reporting for Cellular Therapy
Report co-morbidities that were detected within six months of the cellular therapy, which is different than HCT reporting. The six-month rule applies to assessments that need to be performed in order to determine if a comorbidity is present (i.e., PFT for pulmonary, liver values for hepatic, creatinine for renal, BMI for obesity, etc.). If the co-morbidity is denoted as “ANY history”, the six-month rule does not apply.

The criteria for reporting comorbidities are based on Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.

Report if the recipient has a documented history and / or current diagnosis of any of the conditions listed in Appendix J: Reporting Comorbidities.

Report all comorbidities including those that are considered complications of the primary disease for infusion. See examples below.

• A recipient with sickle cell had a stroke prior to HCT, the comorbidity to report would be Cerebrovascular disease.
• A toddler with Hurler Syndrome has cardiomyopathy, cardiac valvular disease and an ejection fraction of 45%, the comorbidities to report would be Cardiac and Heart valve disease.

The intent of this question is to identify serious pre-existing conditions that may influence the outcome of the infusion. For the purposes of this manual, the term “clinically significant” refers to conditions that are being treated at the time of pre-infusion evaluation or are in the recipient’s medical history and could cause complications post-infusion. Conditions listed in the recipient’s medical history that have been resolved (i.e., appendectomy), and/or that would not pose a concern during or after the infusion should not be reported.

For information regarding reporting clinically significant co-existing disease or organ impairment, see Appendix J: Reporting Comorbidities.

Question 114: Co-existing diseases or organ impairments

Select each clinically significant co-existing disease or organ impairment for this recipient. The definitions for each of the categories are taken from Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.

The physician performing the recipient’s pre-infusion evaluation may use the HCT Co-Morbidity Index (HCT-CI) to document co-morbid conditions. For detailed information on what should and shouldn’t be reported for each category see Appendix J: Reporting Comorbidities.

Question 115: Was the recipient on dialysis immediately prior to start of lymphodepleting therapy?

Indicate if the recipient was dialysis, hemodialysis, or peritoneal dialysis dependent within approximately one month prior to the start of the lymphodepleting therapy.

*Reporting More Than One Prior Solid Organ Transplant
Complete Specify organ and Year of prior solid organ transplant questions for each solid organ transplant by adding an additional instance in FormsNet3^SM.

Questions 116 – 119: Did the recipient have a prior solid organ transplant?

Indicate if the recipient had a prior solid organ transplant. If Yes, specify the organ transplant, and the year of the solid organ transplant.

If Other organ is reported, specify the organ.

If the recipient did not receive a prior solid organ transplant or it is not known, report No.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Section Updates:

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

Copyright © 2004-2025 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.