Q50 – 56: Infection

*Combined Follow-Up
In scenarios where both HCT and cellular therapy forms are being completed, duplicate questions will exist between the Cellular Therapy Essential Data Follow-Up (4100) form and the Post-HCT Data (2100) or Post-Transplant Essential Data (2450) form. To reduce the reporting burden, duplicate questions, including infection, on the Post-Transplant Essential Data (2450) form are disabled when there is a cellular therapy and an HCT.

*Reporting Multiple COVID-19 Infections
FormsNet3^SM application: Complete questions 50 – 51 to report multiple COVID-19 infections by adding an additional instance in the FormsNet3^SM application. A separate instance should be added for each infection.
Paper form submission: Copy questions 50 – 51 and complete to report multiple COVID-19 infections occurring in the current reporting period. A separate instance should be completed for each 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 (2149) form will be generated.

*Reporting COVID-19 Reinfection
There have been cases of recipients recovering from COVID-19 infection, only to later test positive again. For CIBMTR purposes, a new COVID-19 infection should be reported when a recipient tests positive again >21 days from resolution (resolution defined as no signs or symptoms of infection, or a negative diagnostic test).

Questions 50 – 51: Did the recipient develop COVID-19 (SARS-CoV-2) since the date of last report?

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 .

As a result of the global COVID-19 pandemic, the U.S. Food and Drug Administration granted Sherlock Biosciences an emergency use of authorization (EUA) for its COVID-19 diagnostic assay, CRISPR. Although still in its infancy in real-life application, positive results by this method should be reported, even if tandem testing by other method(s) (i.e., PCR) indicate a negative result. If the CRISPR results are unclear, seek physician clarification.

Indicate whether or not the recipient has ever had a known COVID-19 (SARS-CoV-2) infection, based on a positive test result, at any time during the current reporting period.

If the recipient has had a documented COVID-19 (SARS-CoV-2) infection, report Yes and then specify the first date of the pathological diagnosis.

If the recipient has not had a documented COVID-19 (SARS-CoV-2) infection, report No and continue with question 52.

Possible Reporting Scenarios:

Do NOT report an infection in the following scenarios:

• A recipient only has a positive antibody result

• The recipient was symptomatic and treated, but COVID-19 diagnostic testing was not performed and / or COVID-19 diagnostic testing was performed and negative

DO report an infection in the following scenarios:

• A recipient has a positive COVID-19 diagnostic result (PCR or antigen) regardless of if treatment was given or if the recipient was asymptomatic
• A recipient has a positive antibody result and a positive COVID-10 diagnostic test (PCR or antigen)

!COVID-19 Vaccine
If the recipient received a COVID-19 vaccine at any time (including pre- or post-infusion) prior to October 2021 (before the COVID-19 vaccine questions were available on the Post-TED (2450) form), select Yes for question 52 at the first opportunity this form becomes available. When reporting the vaccine date, report the actual date the recipient received the vaccine, even if the date is outside of the reporting window or prior to infusion, override the error as Verified Correct and specify in the comments “Per CIBMTR instructions, report actual vaccine date and verify data field as correct.”

Question 52: 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) within the current reporting period.

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, and continue with question 57.

Revaccination Post – Infusion

When vaccines are given post-infusion, the physician should make the determination on whether the doses are part of the primary series of vaccines, third primary dose, boosters, or revaccination. If a recipient receives a new course of COVID-19 vaccines following infusion as revaccination, report the vaccines as a new series. The most up to date CDC COVID-19 vaccine information for immunocompromised people can be found here.

*COVID-19 Vaccine Doses
FormsNet3^SM application: Complete questions 53 – 56 to report all COVID-19 vaccine doses received in the current reporting period by adding an additional instance in the FormsNet3SM application. A separate instance should be added for each dose.
Paper form submission: Copy questions 53 – 56 and complete report all COVID-19 vaccine doses received in the current reporting period. A separate instance should be completed for each dose

Questions 53 – 54: Specify vaccine brand

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.

*Third dose versus Booster dose
To determine between a third dose and a booster dose, seek clinician clarification, as needed, using the guidelines listed below:
Third dose: An additional primary dose required for recipients who did not build enough protection from their primary vaccine series, typically for immunocompromised individuals
Booster dose: Administered to recipients who have enough protection after completing their primary vaccine series but then protection decreases over time
Primary vaccine series:
- Two doses of Pfizer-BioNTech or Moderna
- One dose of Johnson & Johnson’s Janssen

Questions 55 – 56: Select dose(s) received

For the reported dose, specify the vaccine dose the recipient in the current reporting period and specify the date when the dose was received. If the exact date is not known, use the process described in the General Instructions, Guidelines for Completing Forms and select Date estimated.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
Q50 – 51	4/8/2022	Add	Clarification added on when to report a COVID-19 infection:Possible Reporting Scenarios: Do NOT report an infection in the following scenarios: A recipient only has a positive antibody result. ; The recipient was symptomatic and treated, but COVID-19 diagnostic testing was not performed and / or COVID diagnostic testing was performed and negative. DO report an infection in the following scenarios: A recipient has a positive COVID diagnostic result (PCR or antigen) regardless of if treatment was given or if recipient was asymptomatic; A recipient has a positive antibody result and a positive COVID-19 diagnostic test (PCR or antigen)	Added for clarification and to be consistent with Pre-TED (2400) reporting instructions.
Q50 – 51	4/8/2022	Add	COVID-19 Reinfection blue box added in Q50 – 51: Reporting COVID-19 Reinfection There have been cases of recipients recovering from COVID-19 infection, only to later test positive again. For CIBMTR purposes, a new COVID-19 infection should be reported when a recipient tests positive again >21 days from resolution (resolution defined as no signs or symptoms of infection, or a negative diagnostic test).	Added for clarification
Q50 – 56	5/18/2022	Add	Combined Follow-Up blue instruction box added: In scenarios where both HCT and cellular therapy forms are being completed, duplicate questions will exist between the Cellular Therapy Essential Data Follow-Up (4100) form and the Post-HCT Data (2100) or Post-Transplant Essential Data (2450) form. To reduce the reporting burden, duplicate questions, including infection, on the Post-Transplant Essential Data (2450) form are disabled when there is a cellular therapy and an HCT.	Added for clarification
Q52	3/24/2022	Add	COVID-19 Vaccine blue box added above question 52: COVID-19 Vaccine: If the recipient received a COVID-19 vaccine at any time (including pre- or post-infusion) prior to October 2021 (before the COVID-19 vaccine questions were available on the Post-TED (2450) form), select Yes for question 52 at the first opportunity this form becomes available. When reporting the vaccine date, report the actual date the recipient received the vaccine, even if the date is outside of the reporting window or prior to infusion, override the error as Verified Correct and specify in the comments “Per CIBMTR instructions, report actual vaccine date and verify data field as correct.”	Added for clarification and to be consistent with Post-Infusion Follow-Up (2100) reporting instructions.
Q52	4/8/2022	Add	Clarification added in regard to revaccination post-infusion: 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) within the current reporting period. 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, and continue with question 57. Revaccination Post-Infusion: When vaccines are given post-infusion, the physician should make the determination on whether the doses are part of the primary series of vaccines, third primary dose, boosters, or revaccination. If a recipient receives a new course of COVID vaccines following infusion as revaccination, report the vaccines as a new series. The most up to date CDC COVID-19 vaccine information for immunocompromised people can be found here.	Added for clarification
Q53-54	4/7/2022	Add	Third dose versus Booster dose blue box added above question 55 – 56: Third dose versus Booster dose: To determine between a third dose and a booster dose, seek clinician clarification, as needed, using the guidelines listed below: Third dose: An additional primary dose required for recipients who did not build enough protection from their primary vaccine series, typically for immunocompromised individuals Booster dose: Administered to recipients who have enough protection after completing their primary vaccine series but then protection decreases over time Primary vaccine series: Two doses of Pfizer-BioNTech or Moderna One dose of Johnson & Johnson’s Janssen.”	Added for clarification.
Q53 – 54	4/8/2022	Add	Clarification added on what to report if vaccine brand is Unknown: For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify in question 92. If the vaccine brand is unknown, leave the field blank and override the error as Unknown.	Added for clarification.

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CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®/Be The Match® and the Medical College of Wisconsin