Question 87: Has the patient been infected with COVID-19 (SARS-CoV-2) based on a positive test result at any time prior to the start of the preparative regimen / infusion?
SARS-CoV-2 is a novel virus belonging to the coronavirus (CoV) family that emerged in December 2019. The disease caused by this new CoV is known as COVID-19 (coronavirus disease 2019). The new virus is highly contagious and was officially declared a pandemic in March 2020. Transmission is believed to be from person to person through respiratory droplets from coughing and sneezing. Testing for COVID-19 is generally performed on specimens collected from a nasal swab or sputum sample.
Indicate whether or not the patient has ever had a known COVID-19 (SARS-CoV-2) infection, based on a positive test result, at any time prior to the start of the preparative regimen or infusion (if no preparative regimen was given).
If the patient has had a documented COVID-19 (SARS-CoV-2) infection, report Yes.
If the patient has not had a documented COVID-19 (SARS-CoV-2) infection, report No.
If this is a subsequent infusion and the documented COVID-19 (SARS-CoV-2) infection was already reported on previous forms, report No.
Possible Reporting Scenarios:
An infection should not be reported if:
- A recipient has a positive antibody result. They do not have a history of positive COVID diagnostic results (PCR or antigen).
- The recipient was symptomatic and treated, but COVID-19 diagnostic testing was not performed and / or COVID diagnostic testing was performed and negative.
An infection should be reported if:
- A recipient has a positive COVID diagnostic result (PCR or antigen). No treatment was given and/or recipient was asymptomatic.
Question 88: Did the patient require hospitalization for management for COVID-19 (SARS-CoV-2) infection?
Report Yes if the recipient was admitted to the hospital for management of their COVID-19 (SARS-CoV-2) infection. This includes any regular hospital or intensive care unit (ICU) admissions. Otherwise, report No.
Question 89: Was mechanical ventilation used for COVID-19 (SARS-CoV-2) infection?
The clinical spectrum of COVID-19 varies from asymptomatic or paucisymptomatic forms to clinical conditions characterized by respiratory failure that necessitates mechanical ventilation and support in an intensive care unit (ICU). Mechanical ventilation may impact the recipient’s pulmonary function post-infusion. Indicate Yes or No if the recipient was placed on mechanical ventilation for COVID-19.
Question 90: Was a vaccine for COVID-19 (SARS-CoV-2) received?
Indicate if the recipient received a vaccine for COVID-19 (one dose without a planned second dose, first dose with planned second dose, second dose, third dose, and / or booster dose) at any time prior to the start of the preparative regimen / infusion.
If the recipient did not receive a vaccine for COVID-19 or it is not known if the recipient received a vaccine, select No or Unknown, respectively.
If this is a subsequent infusion and all vaccine doses have already been reported on previous forms, select No.
If this is a subsequent infusion and some, but not all vaccine doses have already been reported on previous forms select Yes and only report the vaccine doses not previously reported.
Questions 91 – 92: Specify vaccine type
For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify. If the vaccine brand is unknown, leave the field blank and override the error as ‘unknown.’
Questions 93 – 94: Select dose(s) received
For the reported dose, specify the vaccine dose the recipient received prior to the start of the preparative regimen / infusion and report the date when the dose was received.
Select One dose (without planned second dose) if the recipient received a single dose, without the plans of receiving the second dose and report the date of administration.
Select First dose (with planned second dose) if the recipient received their first dose, with plans for receiving the second dose and report the date of administration.
Select Second dose if this is the recipient’s planned second dose of the vaccine and report the date of administration.
Refer to the blue instructional box above for additional information regarding third and booster doses.
If the exact date is not known, use the process described in the General Instructions, Guidelines for Completing Forms and select Date estimated.
Question 95: Is there a history of mechanical ventilation (excluding COVID-19 (SARS-CoV-2)?
A history of mechanical ventilation may impact the recipient’s pulmonary function post-HCT. Mechanical ventilation is any assisted ventilation on behalf of the recipient. Mechanical ventilation can occur as both an endotracheal tube and ventilator, or as a BIPAP machine with a tight fitting mask in continuous use. The one exception to BIPAP is CPAP used for sleep apnea, which generally involves overnight use only for patients with documented sleep apnea. Therefore, do not report a CPAP used for sleep apnea, as it does not have the same implications as other forms of mechanical ventilation.
Indications for mechanical ventilation include, but are not limited to:
- Apnea with respiratory arrest (excludes sleep apnea)
- Acute lung injury
- Vital capacity < 15 mL/kg
- Chronic obstructive pulmonary disease (COPD)
- Clinical deterioration
- Respiratory muscle fatigue
- Obtundation or coma
- Hypotension
- Tachypnea or bradypnea
If the recipient was placed on mechanical ventilation at any time prior to this HCT event (excluding mechanical ventilation during surgery) check Yes. If the recipient does not have a history of mechanical ventilation, check No.
Question 96: Is there a history of invasive fungal infection?
Fungal infections play a major role in the clinical outcome of transplant recipients. If the recipient has a history of proven, suspected, or documented invasive fungal infection at any time prior to this HCT, check Yes. If the recipient has not had a history of a proven, suspected, or documented invasive fungal infection, check No. For a subsequent HCT, report any documented significant fungal infections in the recipient’s medical history, starting with the preparative regimen of the previous HCT to the time prior to the preparative regimen for the current HCT.
Examples of invasive fungal infections include, but are not limited to invasive aspergillosis, zygomycosis and other molds, invasive candidiasis, cryptococcosis, endemic mycosis, other yeasts, and pneumocystosis.
Non-invasive fungal infections such as thrush and nail fungus should not be reported.
For assistance with reporting fungal infections, consult a transplant physician.
Questions 97 – 98: Glomerular filtration rate (GFR) before start of the preparative regiment (pediatric only)
The glomerular filtration rate (GFR) estimates how much blood passes through the glomeruli each minute and is used to check how well the kidneys are working. Indicate if the GFR is Known or Unknown. If the GFR is Known, indicate the value for this test.
Testing may be performed multiple times within the pre-transplant work-up period; report the most recent laboratory value obtained. Laboratory values obtained on the first day of the preparative regimen may be reported as long as the blood was drawn before any radiation or systemic therapy was administered.
If the GFR is reported as a range, report the average of the range.
If the GFR is reported as either “< X” or “> X,” report the value as X – 1 or X + 1, respectively.
If the actual GFR result is not available, an estimated GFR may be reported, using the GFR calculator or the GFR may be calculated using either the bedside Schwartz or cystatin C-based equations..
Question 99: Does the recipient have a known complex congenital heart disease? (corrected or uncorrected (excluding simple ASD, VSD, or PDA repair) (pediatric only)
The intent of this question is to determine the pediatric recipient’s history of any known complex congenital heart disease (corrected or uncorrected). Exceptions for reporting would be any simple ASD, VSD, or PDA repair. Indicate Yes if the recipient has known complex congenital heart disease, or No if they do not.
Question 100: Were there any co-existing diseases or organ impairment present according to the HCT comorbidity index (HCT-CI)?
(Source: Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.)
The criteria for reporting comorbidities is based on Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.
Report Yes 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 transplant. See examples below.
- A patient 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” & “heart valve disease”.
The intent of this question is to identify serious pre-existing conditions that may have an effect on the outcome of the HCT. For the purposes of this manual, the term “clinically significant” refers to conditions that are being treated at the time of pre-HCT evaluation or are in the recipient’s medical history and could cause complications post-HCT. Conditions listed in the recipient’s medical history that have been resolved (e.g., appendectomy), and/or that would not pose a concern during or after the HCT should not be reported.
Additionally, for the purposes of this manual, the term “at the time of patient assessment” is defined as the pre-HCT evaluation period prior to the start of the preparative regimen. If the recipient does not have a documented history of clinically significant disease(s) or organ impairment(s), check No.
For information regarding reporting clinically significant co-existing disease or organ impairment, see Appendix J: Reporting Comorbidities.
Question 101: Specify co-existing disease or organ impairments (check all that apply)
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-HCT 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 102: Was the recipient on dialysis immediately prior to start of preparative regimen?
Indicate if the recipient was dialysis, hemodialysis, or peritoneal dialysis dependent within approximately one month prior to the start of the preparative regimen.
Questions 103 – 105: Specify prior malignancy (check all that apply)
Specify the recipient’s prior solid tumor(s) and / or hematologic malignancy(ies).
If Other skin malignancy is selected, specify the skin malignancy.
If Other prior hematologic malignancy is selected, specify the hematologic malignancy.
If Other prior solid tumor is selected, specify the solid tumor.
Questions 106 – 115: Provide last laboratory values recorded within four weeks prior to the start of the preparative regimen
These questions are intended to determine the clinical status of the recipient prior to the start of the preparative regimen for stem cell transplantation. Testing may be performed multiple times prior to the start of the preparative regimen; report the most recent laboratory value obtained for each specific test. Laboratory values obtained on the first day of the preparative regimen may be reported as long as the blood was drawn before any radiation or systemic therapy was administered.
For each assessment below, indicate if the result was Known or Unknown prior to the start of the preparative regimen. Indicate the value for each test. If necessary, convert values so they can be reported in the units of measurement available on the form.
Serum ferritin: Ferritin is a protein that stores, transports, and release iron. Iron is toxic to cells, so it is stored within the ferritin protein for use. Ferritin that is too low might be indicative of iron deficiency related anemia. Ferritin that is too high might be indicative of iron overload. It is tracked for some diseases, such as hemaophagocytic lymphohistiocytosis.
Date Sample Collected: Report the date the sample was collected. This date should be before the date of the start of the preparative regimen; however, laboratory values obtained on the first day of the preparative regimen may be reported as long as the blood was drawn before any radiation or systemic therapy was administered.
Upper Limit of Normal for your Institution: Report the upper limit of normal. Normal values may vary by laboratory, so it is important to report the upper limit of normal for each assessment.
Serum albumin: Serum albumin is a protein found in the blood. Levels are most often reported on a chemistry panel but may occasionally be found in a separate liver function test report.
Date Sample Collected: Report the date the sample was collected. This date should be before the date of the start of the preparative regimen; however, laboratory values obtained on the first day of the preparative regimen may be reported as long as the blood was drawn before any radiation or systemic therapy was administered.
Platelets: Platelet are formed elements within the blood that help with coagulation. A low platelet count, call thrombocytopenia, may lead to easy bleed or bruising. Thrombocytopenia may require platelet transfusions. Indicate if the recipient received a platelet transfusion within 7 days prior to testing.
Questions 116 – 118: 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.
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.
Question 119: Year of prior solid organ transplant
If a recipient received a solid organ transplant during the reporting period, report the date of the solid organ transplant.
For more information regarding 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) |
|---|---|---|---|---|
| Q87 | 4/19/2024 | Modify | The Diagnosis of COVID-19 After the Start of the Preparative Regimen blue box removed and the COVID-19 Infection red box added to clarify these questions are now disabled. | Due to disabling of questions with the Spring 2024 release |
| Q90 | 4/19/2024 | Modify | The COVID-19 Vaccine red box updated to clarify these questions are now disabled. | Due to disabling of questions with the Spring 2024 release |
| Q100 | 8/28/2023 | Remove | Removed the Hepatic and Renal Comorbidities blue box from Q100: Hepatic Comorbidity: The assessment of liver function tests (ALT, AST and/or Total Bilirubin) has to include at least 2 values per test on two different days within a period extending between day -24 and the start of the systemic therapy regimen/lymphodepleting therapy. If no therapy was given, then it would be day -24 and the cellular therapy infusion date. If only a single value was reported in this time period, use the most recent test performed between days -40 & -25 as the second value. When determining the severity of the hepatic comorbidity, the value closest to the start of the systemic therapy regimen/lymphodepleting therapy should be used. If the liver function test values closest to the start of the preparative regimen do not meet the criteria specified above, a hepatic comorbidity should not be reported. Renal (Moderate/Severe) Comorbidity: Serum creatinine > 2 mg/dL or > 177 μmol/L, as detected in at least two lab values on two different days within a period extending between day -24 and the start of the systemic therapy regimen/lymphodepleting therapy. If no systemic therapy was given, then it would be day -24 and the cellular therapy infusion date. If only a single value was reported in this time period, use the most recent test performed between days -40 & -25 as the second value. If the serum creatinine value closest to the start of the systemic therapy regimen/lymphodepleting therapy did not meet the criteria specified above, a renal (moderate/severe) comorbidity should not be reported. |
All comorbidity information has been consolidated to Appendix J |
| Q100 | 8/28/2023 | Remove | Removed the ‘documented medical history from Q100:‘ -Arrhythmia that has required specific antiarrhythmic treatment -Cardiac -Cerebrovascular disease -Inflammatory bowel disease -Peptic ulcer -Rheumatologic -Prior malignancy, requiring treatment Current Diagnosis at the Time of Pre-Infusion Evaluation -Diabetes -Heart valve disease -Hepatic, mild -Hepatic, moderate/severe -Infection -Obesity -Psychiatric disturbance -Pulmonary, moderate -Pulmonary, severe -Renal, moderate/severe 2Ejection fraction (EF) ≤ 50% should be reported only if present on most recent test 3Excluding asymptomatic mitral valve prolapse 4Including any history of hepatitis B or hepatitis C infection 5If the PFT lists both a “control” FEV1 and a “post-dilator” FEV1, the “control” FEV1 should be used to determine if a pulmonary comorbidity is present. 6Including renal transplantation at any time in the patient’s history |
All comorbidity information has been consolidated to Appendix J |
| Q101 | 8/28/2023 | Remove | Removed each specific comorbidity and it’s criteria | All comorbidity information has been consolidated to Appendix J |
| Q106 | 4/4/2024 | Add | Plasma vs Serum Samples blue box added | Added for clarification |
| Q106 | 2/21/2024 | Add | ATG / Campath blue box added | Added for clarification |
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