Question 88: 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” and continue with question 89.

If the patient has not had a documented COVID-19 (SARS-CoV-2) infection, report “no” and continue with question 91.

Question 89: Did the patient require hospitalization for management of 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” and continue with question 91.

Question 90: Was mechanical ventilation given 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)1. Mechanical ventilation may impact the recipient’s pulmonary function post-infusion. Report “yes” if the recipient was placed on mechanical ventilation for COVID-19 and continue with question 91.

Question 91: 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 92: 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.

Question 93-94: Glomerular filtration rate (GFR) before start of preparative regimen (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. Please indicate if the GFR is “known” or “unknown” in question 93. If the GFR is known, indicate the value for this test in question 94.

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.

Question 95: Does the recipient have 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 96: Were there 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

1 Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.

Report “yes” to question 93 if the recipient has a documented history and/or current diagnosis of any of the following:

Documented Medical History

  • Arrhythmia
  • Cardiac2
  • Cerebrovascular disease
  • Inflammatory bowel disease
  • Peptic ulcer
  • Rheumatologic
  • Prior malignancy

Current Diagnosis at the Time of Pre-HCT Evaluation

  • Diabetes
  • Heart valve disease3
  • Hepatic, mild4
  • Hepatic, moderate/severe
  • Infection
  • Obesity
  • Psychiatric disturbance
  • Pulmonary, moderate5
  • Pulmonary, severe5
  • Renal, moderate/severe6

2 Ejection fraction (EF) ≤ 50% should be reported only if present on most recent test

3 Excluding asymptomatic mitral valve prolapse

4 Including any history of hepatitis B or hepatitis C infection

5 If 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.

6 Including renal transplantation at any time in the patient’s history

Examples of complications of the primary disease for transplant that should be reported as comorbidities.

  • 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” and continue with question 135.

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

Question 97: Specify co-existing diseases or organ impairment (check all that apply)

From the list in question 94, select each clinically significant co-existing disease or organ impairment for this recipient. The definitions for each of the categories below are taken from Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.

Arrhythmia: Any history of any type of arrhythmia that has necessitated the delivery of a specific antiarrhythmic agent. Examples include, but are not limited to, atrial fibrillation or flutter, sick sinus syndrome, and ventricular arrhythmias.

Cardiac: Any history of coronary artery disease (one or more vessel coronary artery stenosis requiring medical treatment, stent, or bypass graft), congestive heart failure (regardless of an LVEF >50% at the start of the preparative regimen), myocardial infarction, and / or ejection fraction ≤ 50% (shortening fraction < 26% for pediatric recipients) on the most recent test.

Cerebrovascular disease: Any history of transient ischemic attack, subarachnoid hemorrhage, and / or cerebral thrombosis embolism, or hemorrhage.

Diabetes: Diabetes or steroid-induced hyperglycemia requiring continuous treatment with insulin or oral hypoglycemics in the last 4 weeks.

Heart valve disease: Moderate or severe valve stenosis or insufficiency (mitral, aortic, tricuspid, or pulmonary) as determined by the most recent heart evaluation by an echocardiogram, prosthetic mitral or aortic valve, and / or symptomatic mitral valve prolapse. This does not include a documented medical history of heart valve disease.

Hepatic (mild): Chronic hepatitis, bilirubin > upper limit of normal to 1.5x upper limit of normal, or AST/ALT > upper limit of normal to 2.5x upper limit of normal, or any history of hepatitis B or hepatitis C infection. See note in question 97.

Hepatic (moderate/severe): Liver cirrhosis, bilirubin > 1.5x upper limit of normal, or AST/ALT > 2.5x upper limit of normal. See note in question 97.

Infection: Documented infection, fever of unknown origin, or pulmonary nodules requiring continuation of antimicrobial / antifungal / antiviral treatment after day 0.

Inflammatory bowel disease: Any history of Crohn’s disease or ulcerative colitis requiring treatment.

Obesity: Patients with a body mass index > 35.00 kg/m2 or BMI-for-age ≥ 95% (pediatric recipients only) during pre-transplant work-up period. For pediatric recipients, if only the BMI is known, refer to the following link to determine the BMI-for-age: https://www.cdc.gov/growthcharts/.

Peptic ulcer: Any history of peptic ulcer confirmed by endoscopy and requiring treatment.

Psychiatric disturbance: The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks.

Pulmonary (moderate): Corrected diffusion capacity of carbon monoxide (e.g., DLCOc, DLCOcorr, DLCO) and/or FEV1 66-80% or dyspnea on slight activity at transplant. Use the Dinakara equation below to determine the DLCOc if only an uncorrected value is provided. For recipients assessed by a postbronchodilator test, only the prebronchodilator FEV1 values are considered for evaluation of pulmonary comorbidity.

Dinakara Equation: DLCOc = {uncorrected DLCO} / [0.06965 x {hemoglobin g/dL}]

Pulmonary (severe): Corrected diffusion capacity of carbon monoxide (e.g., DLCOc, DLCOcorr, DLCO) and/or FEV1 ≤ 65% or dyspnea at rest or requiring oxygen at transplant. Use the Dinakara equation above to determine the DLCOc if only an uncorrected value is provided. or recipients assessed by a postbronchodilator test, only the prebronchodilator FEV1 values are considered for evaluation of pulmonary comorbidity.

Renal (moderate/severe): Serum creatinine > 2 mg/dL or > 176.8 μmol/L, or on dialysis at transplant, or prior renal transplantation. See note in question 93.

If renal (moderate / severe) comorbidity is selected, complete question 95.

Rheumatologic: Any history of systemic lupus erythematosus, rheumatoid arthritis, polymyositis, mixed connective tissue disease, or polymyalgia rheumatica requiring treatment (do NOT include degenerative joint disease, osteoarthritis)

Prior Malignancy, specify: Any solid tumor(s) and / or hematologic malignancy(ies) that have been treated at any time point in the patient’s past history. A history of any benign tumor(s) should not be reported.

If the recipient is transplanted for a disease that has transformed from one disease to another, the original malignancy should not be reported in this section. Details regarding disease transformation will be captured on the Pre-TED Disease Classifiation form (Form 2402). For more information regarding disease combinations and transformations, refer to the Common Disease Combinations and Common Disease Transformations tables in the Primary Disease for HCT section of the Pre-TED Disease Classification Form (Form 2402).

If prior malignancy, specify is selected, complete question 96.

The physician performing the recipient’s pre-HCT evaluation may use the HCT Co-Morbidity Index (HCT-CI) to document co-morbid conditions (see Appendix J).

Question 98: 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.

Question 99-102: 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 in question 100.

If “Other prior hematologic malignancy” is selected, specify the hematologic malignancy in question 101.

If “Other prior solid tumor” is selected, specify the solid tumor in question 102.

Questions 103-112: Provide last laboratory values recorded just 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.

Question 113-115: Did the recipient have a prior solid organ transplant?

Indicate if it is “known” or “unknown” if the recipient had a prior solid organ transplant. If “known,” specify the organ transplant in question 114. If “Other organ” is reported, specify the organ in question 115. If the recipient did not receive a prior solid organ transplant or it is not known, report “no” for question 113 and continue with question 117.

Question 116: 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)
. . . . .
Last modified: Dec 22, 2020

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