Download:
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pdfInformation Collection Domain: Transplant Procedure and Product Information
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
yes
Sequence Number: Auto Filled Field
Sequence Number:
Auto Filled Field
yes
Date Received:
CIBMTR Center
Number:
CIBMTR Research
ID:
Auto Filled Field
Date Received:
Auto Filled Field
Auto Filled Field
CIBMTR Center Number:
Auto Filled Field
CIBMTR Research ID:
Auto Filled Field
Event date:
Auto Filled Field created with CRID
HCT type (check all that apply)
Allogeneic, related,Allogeneic, unrelated
Bone marrow,Other
product,PBSC,Single
cord blood unit
Product type (check all that apply)
Bone marrow,Other product,PBSC,Single cord blood unit
open text
Other product. Specify:
open text
Registry donor ID:
open text
Non-NMDP cord blood unit ID:
open text
yes
yes
no
Current
Information
Collection Data
Element
Response
Option(s)
no
Auto Filled Field
Auto Filled Field
Event date:
created with CRID
Allogeneic,
HCT type (check all related,Allogeneic,
that apply)
unrelated
Product type
(check all that
apply)
Other product.
Specify:
no
no
no
no
no
no
no
no
Registry donor ID: open text
Non-NMDP cord
blood unit ID:
open text
no
no
Global Registration
Identifier for
Donors (GRID)
open text
Global Registration Identifier for
Donors (GRID)
open text
no
no
ISBT DIN:
ISBT DIN:
open text
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
open text
Rationale for Information Collection
Update
Page 1 of 41
Information
Collection
Domain SubType
Infectious Disease
Markers
Infectious Disease
Markers
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Donor DOB:
YYYY/MM/DD
Donor age:
YYYY/MM/DD
open text, check
"Months" or check
"Years"
Donor age:
open text, check "Months" or check "Years"
Donor sex
female,male
Donor sex
female,male
Who is being
tested for IDMs?
donor IDM (marrow
or PBSC),cord blood
unit IDM,maternal
IDM (cord blood)
Who is being tested for IDMs?
donor IDM (marrow or PBSC),cord blood unit
IDM,maternal IDM (cord blood)
Registry or UCB
Bank ID
no
no
Donor DOB:
no
no
no
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Infectious Disease Blood Unit
Markers
Information
yes
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
(A) Austrian Bone Marrow Donors,(ACB) Austrian Cord
Registry or UCB Bank ID
no
Marrow
Donors,(ACB)
Austrian Cord Blood
Registry,(ACCB)
StemCyte, Inc,(AE)
Emirates Bone
Marrow Donor
Registry,(AM)
Armenian Bone
Marrow Donor
Registry Charitable
Trust,(AOCB)
University of
Colorado Cord
Blood Bank,(AR)
Argentine CPH
Donors
Registry,(ARCB)
BANCEL - Argentina
Cord Blood
Bank,(AUCB)
Australian Cord
Blood
Registry,(AUS)
Australian / New
Zealand Bone
Marrow Donor
Registry,(B) Marrow
Information Collection update:
Blood Registry,(ACCB) StemCyte, Inc,(AE) Emirates Bone
Marrow Donor Registry,(AM) Armenian Bone Marrow
Donor Registry Charitable Trust,(AOCB) University of
Colorado Cord Blood Bank,(AR) Argentine CPH Donors
Registry,(ARCB) BANCEL - Argentina Cord Blood
Bank,(AUCB) Australian Cord Blood Registry,(AUS)
Australian / New Zealand Bone Marrow Donor
Registry,(B) Marrow Donor Program Belgium,(BCB)
Belgium Cord Blood Registry,(BG) Bulgarian Bone Marrow
Donor Registry,(BR) INCA/REDOMO,(BSCB) British Bone
Marrow Registry - Cord Blood,(CB) Cord Blood
Registry,(CH) Swiss BloodStem Cells - Adult
Donors,(CHCB) Swiss Blood Stem Cells - Cord
Blood,(CKCB) Celgene Cord Blood Bank,(CN) China
Marrow Donor Program (CMDP),(CNCB) Shan Dong Cord
Blood Bank,(CND) Canadian Blood Services Bone Marrow
Donor Registry,(CS2) Czech National Marrow Donor
Registry,(CSCR) Czech Stem Cells Registry,(CY) Cyprus
Paraskevaidio Bone Marrow Donor Registry,(CY2) The
Cyprus Bone Marrow Donor Registry,(D) ZKRD - Zentrales
Knochenmarkspender - Register Deutschland Adult
Donors,(DCB) ZKRD - Zentrales Knochenmarkspender Register Deutschland Cord Blood,(DK) The Danish Bone
Marrow Donor Registry,(DK2) Bone Marrow Donors
Copenhagen (BMDC),(DUCB) German Branch of the
European Cord Blood Bank,(E) REDMO,(ECB) Spanish
Cord Blood Registry,(F) France Greffe de Moelle - Adult
Donors,(FCB) France Greffe de Moelle - Cord Blood,(FI)
no
Infectious Disease
Markers
Infectious Disease
Markers
Current
Information
Collection Data
Element
Response
Option(s)
(A) Austrian Bone
Rationale for Information Collection
Update
Page 2 of 41
Information
Collection
Domain SubType
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
yes
no
HBsAg: (hepatitis B Non-reactive,Not
surface antigen)
done,Reactive
HBsAg: (hepatitis B surface antigen)
Non-reactive,Not done,Reactive
yes
no
Date sample
collected:
Date sample collected:
YYYY/MM/DD
yes
no
Anti HBc: (hepatitis Non-reactive,Not
B core antibody)
done,Reactive
Anti HBc: (hepatitis B core antibody)
Non-reactive,Not done,Reactive
yes
no
Date sample
collected:
Date sample collected:
YYYY/MM/DD
yes
no
FDA licensed NAAT Negative,Not
testing for HBV
done,Positive
FDA licensed NAAT testing for HBV
Negative,Not done,Positive
yes
no
Date sample
collected:
YYYY/MM/DD
Date sample collected:
YYYY/MM/DD
no
Anti-HCV:
(hepatitis C
antibody)
Non-reactive,Not
done,Reactive
Anti-HCV: (hepatitis C antibody)
Non-reactive,Not done,Reactive
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
YYYY/MM/DD
YYYY/MM/DD
Rationale for Information Collection
Update
Page 3 of 41
Information
Collection
Domain SubType
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
yes
no
Date sample
collected:
yes
no
yes
Current
Information
Collection Data
Element
Response
Option(s)
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Date sample collected:
YYYY/MM/DD
FDA licensed NAAT Negative,Not
testing for HCV
done,Positive
FDA licensed NAAT testing for HCV
Negative,Not done,Positive
no
Date sample
collected:
Date sample collected:
YYYY/MM/DD
yes
no
Non-reactive,Not
done,Not
HIV-1 p24 antigen reported,Reactive
HIV-1 p24 antigen
Non-reactive,Not done,Not reported,Reactive
yes
no
Date sample
collected:
Date sample collected:
YYYY/MM/DD
yes
no
FDA licensed NAAT Negative,Not
testing for HIV-1
done,Positive
FDA licensed NAAT testing for HIV-1
Negative,Not done,Positive
yes
no
Date sample
collected:
Date sample collected:
YYYY/MM/DD
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
YYYY/MM/DD
Information Collection update:
YYYY/MM/DD
YYYY/MM/DD
YYYY/MM/DD
Rationale for Information Collection
Update
Page 4 of 41
Information
Collection
Domain SubType
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
yes
no
Anti-HIV 1 and antiHIV 2*: (antibodies
to Human
Non-reactive,Not
Immunodeficiency done,Not
Viruses)
reported,Reactive
yes
no
Date sample
collected:
YYYY/MM/DD
Date sample collected:
YYYY/MM/DD
yes
no
Chagas testing
Negative,Not
Done,Positive
Chagas testing
Negative,Not Done,Positive
yes
no
Date sample
collected:
YYYY/MM/DD
Date sample collected:
YYYY/MM/DD
yes
no
Anti-HSV (Herpes
simplex virus
antibody)
Negative,Not
Done,Positive
Anti-HSV (Herpes simplex virus
antibody)
Negative,Not Done,Positive
yes
no
Date sample
collected:
YYYY/MM/DD
Date sample collected:
YYYY/MM/DD
no
Anti-EBV (Epstein- Inconclusive,Negati
Barr virus
ve,Not
antibody)
done,Positive
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Anti-HIV 1 and anti-HIV 2*:
(antibodies to Human
Immunodeficiency Viruses)
Non-reactive,Not done,Not reported,Reactive
Rationale for Information Collection
Update
Anti-EBV (Epstein-Barr virus antibody) Inconclusive,Negative,Not done,Positive
Page 5 of 41
Information
Collection
Domain SubType
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Infectious Disease
Markers
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
Non NMDP
Allogeneic or
syngeneic Donor or
Non NMDP Cord
Blood Unit
Information
no
Date sample
collected:
yes
yes
Current
Information
Collection Data
Element
Response
Option(s)
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Date sample collected:
YYYY/MM/DD
no
Anti-VZV (Varicella
zoster virus
Negative,Not
antibody)
Done,Positive
Anti-VZV (Varicella zoster virus
antibody)
Negative,Not Done,Positive
no
Date sample
collected:
YYYY/MM/DD
Date sample collected:
YYYY/MM/DD
yes
no
Other infectious
disease marker,
specify
no,yes
Other infectious disease marker,
specify
no,yes
yes
no
Date sample
collected:
YYYY/MM/DD
Date sample collected:
YYYY/MM/DD
yes
no
Specify test and
method:
open text
Specify test and method:
open text
yes
no
Specify test results: open text
Specify test results:
open text
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
YYYY/MM/DD
Information Collection update:
Rationale for Information Collection
Update
Page 6 of 41
Information
Collection
Domain SubType
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
yes
no
Registry donor ID: open text
Registry donor ID:
open text
yes
no
Non-NMDP cord
blood unit ID:
Non-NMDP cord blood unit ID:
open text
yes
no
Global Registration
Identifier for
Donors (GRID)
open text
Global Registration Identifier for
Donors (GRID)
open text
yes
no
ISBT DIN:
ISBT DIN:
open text
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
open text
open text
Rationale for Information Collection
Update
Page 7 of 41
Information
Collection
Domain SubType
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Current
Information
Collection Data
Element
Response
Option(s)
(A) Austrian Bone
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
(A) Austrian Bone Marrow Donors,(ACB) Austrian Cord
yes
no
Registry or UCB
Bank ID
Marrow
Donors,(ACB)
Austrian Cord Blood
Registry,(ACCB)
StemCyte, Inc,(AE)
Emirates Bone
Marrow Donor
Registry,(AM)
Armenian Bone
Marrow Donor
Registry Charitable
Trust,(AOCB)
University of
Colorado Cord
Blood Bank,(AR)
Argentine CPH
Donors
Registry,(ARCB)
BANCEL - Argentina
Cord Blood
Bank,(AUCB)
Australian Cord
Blood
Registry,(AUS)
Australian / New
Zealand Bone
Marrow Donor
Registry,(B) Marrow
yes
no
Donor DOB:
YYYY/MM/DD
Donor DOB:
YYYY/MM/DD
Donor age:
open text, check
"Months" or check
"Years"
Donor age:
open text, check "Months" or check "Years"
yes
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Registry or UCB Bank ID
Blood Registry,(ACCB) StemCyte, Inc,(AE) Emirates Bone
Marrow Donor Registry,(AM) Armenian Bone Marrow
Donor Registry Charitable Trust,(AOCB) University of
Colorado Cord Blood Bank,(AR) Argentine CPH Donors
Registry,(ARCB) BANCEL - Argentina Cord Blood
Bank,(AUCB) Australian Cord Blood Registry,(AUS)
Australian / New Zealand Bone Marrow Donor
Registry,(B) Marrow Donor Program Belgium,(BCB)
Belgium Cord Blood Registry,(BG) Bulgarian Bone Marrow
Donor Registry,(BR) INCA/REDOMO,(BSCB) British Bone
Marrow Registry - Cord Blood,(CB) Cord Blood
Registry,(CH) Swiss BloodStem Cells - Adult
Donors,(CHCB) Swiss Blood Stem Cells - Cord
Blood,(CKCB) Celgene Cord Blood Bank,(CN) China
Marrow Donor Program (CMDP),(CNCB) Shan Dong Cord
Blood Bank,(CND) Canadian Blood Services Bone Marrow
Donor Registry,(CS2) Czech National Marrow Donor
Registry,(CSCR) Czech Stem Cells Registry,(CY) Cyprus
Paraskevaidio Bone Marrow Donor Registry,(CY2) The
Cyprus Bone Marrow Donor Registry,(D) ZKRD - Zentrales
Knochenmarkspender - Register Deutschland Adult
Donors,(DCB) ZKRD - Zentrales Knochenmarkspender Register Deutschland Cord Blood,(DK) The Danish Bone
Marrow Donor Registry,(DK2) Bone Marrow Donors
Copenhagen (BMDC),(DUCB) German Branch of the
European Cord Blood Bank,(E) REDMO,(ECB) Spanish
Cord Blood Registry,(F) France Greffe de Moelle - Adult
Donors,(FCB) France Greffe de Moelle - Cord Blood,(FI)
Rationale for Information Collection
Update
Page 8 of 41
Information
Collection
Domain SubType
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
no
Specify the person
for whom this
typing is being
Donor,Recipientdone
final typing
Specify the person for whom this
typing is being done
Donor,Recipient-final typing
yes
no
Was
documentation
submitted to the
CIBMTR (e.g. lab
report)
No,Yes
Was documentation submitted to the
CIBMTR (e.g. lab report)
No,Yes
yes
no
Locus A
Known,Unknown
Locus A
Known,Unknown
yes
no
First A* allele
designations:
open text
First A* allele designations:
open text
yes
no
Second A* allele
designations:
open text
Second A* allele designations:
open text
yes
no
Locus B
Known,Unknown
Locus B
Known,Unknown
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
female,male
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
female,male
yes
Donor sex
Information Collection update:
Donor sex
yes
no
Current
Information
Collection Data
Element
Response
Option(s)
Rationale for Information Collection
Update
Page 9 of 41
Information
Collection
Domain SubType
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
yes
no
First B* allele
designations:
open text
First B* allele designations:
open text
yes
no
Second B* allele
designations:
open text
Second B* allele designations:
open text
yes
no
Locus C
Known,Unknown
Locus C
Known,Unknown
yes
no
First C* allele
designations:
open text
First C* allele designations:
open text
yes
no
Second C* allele
designations:
open text
Second C* allele designations:
open text
yes
no
Locus DRB1
Known,Unknown
Locus DRB1
Known,Unknown
yes
no
First DRB1* allele
designations:
open text
First DRB1* allele designations:
open text
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Rationale for Information Collection
Update
Page 10 of 41
Information
Collection
Domain SubType
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Current
Information
Collection Data
Element
Response
Option(s)
Second DRB1*
allele designations: open text
open text
Known,Unknown
Locus DRB3
Known,Unknown
open text
First DRB3* allele designations:
open text
Second DRB3* allele designations:
open text
Known,Unknown
Locus DRB4
Known,Unknown
open text
First DRB4* allele designations:
open text
Second DRB4* allele designations:
open text
Known,Unknown
Locus DRB5
Known,Unknown
open text
First DRB5* allele designations:
open text
Second DRB5* allele designations:
open text
Known,Unknown
Locus DQB1
Known,Unknown
open text
First DQB1* allele designations:
open text
Second DQB1* allele designations:
open text
Known,Unknown
Locus DPB1
Known,Unknown
open text
First DPB1* allele designations:
open text
Second DPB1* allele designations:
open text
Known,Unknown
Locus DQA1
Known,Unknown
open text
First DQA1* allele designations:
open text
no
no
no
no
no
Locus DRB3
First DRB3* allele
designations:
no
no
Second DRB3*
allele designations: open text
no
no
no
no
Locus DRB4
First DRB4* allele
designations:
no
no
Second DRB4*
allele designations: open text
no
no
no
no
Locus DRB5
First DRB5* allele
designations:
no
no
Second DRB5*
allele designations: open text
no
no
no
no
Locus DQB1
First DQB1* allele
designations:
no
no
Second DQB1*
allele designations: open text
no
no
no
no
Locus DPB1
First DPB1* allele
designations:
no
no
Second DPB1*
allele designations: open text
no
no
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Second DRB1* allele designations:
yes
Locus DQA1
First DQA1* allele
designations:
Information Collection update:
Rationale for Information Collection
Update
Page 11 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Confirmation of
HLA Typing
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Current
Information
Collection Data
Element
Response
Option(s)
Second DQA1*
allele designations: open text
open text
Known,Unknown
Locus DPA1
Known,Unknown
open text
First DPA1* allele designations:
open text
Second DPA1* allele designations:
open text
A Antigens. Number of antigens
provided
one,two
Specificity – 1st antigen
A1,A10,A11,A19,A2,A203,A210,A23(9),A24(9),A2403,A25
(10),A26(10),A28,A29(19),A3,A30(19),A31(19),A32(19),A3
3(19),A34(10),A36,A43,A66(10),A68(28),A69(28),A74(19),
A80,A9,AX
Specificity – 2nd antigen
A1,A10,A11,A19,A2,A203,A210,A23(9),A24(9),A2403,A25
(10),A26(10),A28,A29(19),A3,A30(19),A31(19),A32(19),A3
3(19),A34(10),A36,A43,A66(10),A68(28),A69(28),A74(19),
A80,A9,AX
B Antigens. Number of antigens
provided
one,two
no
no
no
no
no
Locus DPA1
First DPA1* allele
designations:
no
no
Second DPA1*
allele designations: open text
yes
yes
yes
no
A Antigens.
Number of
antigens provided one,two
A1,A10,A11,A19,A2,
A203,A210,A23(9),
A24(9),A2403,A25(1
0),A26(10),A28,A29
(19),A3,A30(19),A3
1(19),A32(19),A33(
19),A34(10),A36,A4
3,A66(10),A68(28),
Specificity – 1st
A69(28),A74(19),A8
antigen
0,A9,AX
A1,A10,A11,A19,A2,
A203,A210,A23(9),
A24(9),A2403,A25(1
0),A26(10),A28,A29
(19),A3,A30(19),A3
1(19),A32(19),A33(
19),A34(10),A36,A4
3,A66(10),A68(28),
Specificity – 2nd
A69(28),A74(19),A8
antigen
0,A9,AX
no
B Antigens.
Number of
antigens provided one,two
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Second DQA1* allele designations:
no
yes
Information Collection update:
Rationale for Information Collection
Update
Page 12 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Confirmation of
HLA Typing
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Confirmation of
HLA Typing
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
yes
yes
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Specificity – 1st
antigen
Specificity – 2nd
antigen
Current
Information
Collection Data
Element
Response
Option(s)
B12,B13,B14,B15,B
16,B17,B18,B21,B2
2,B27,B2708,B35,B
37,B38(16),B39(16),
B3901,B3902,B40,B
4005,B41,B42,B44(
12),B45(12),B46,B4
7,B48,B49(21),B5,B
50(21),B51(5),B510
2,B5103,B52(5),B53
,B54(22),B55(22),B5
6(22),B57(17),B58(1
7),B59,B60(40),B61(
40),B62(15),B63(15)
,B64(14),B65(14),B6
7,B7,B70,B703,B71(
70),B72(70),B73,B7
5(15),B76(15),B77(1
5),B78,B8,B81,B82,
BX
B12,B13,B14,B15,B
16,B17,B18,B21,B2
2,B27,B2708,B35,B
37,B38(16),B39(16),
B3901,B3902,B40,B
4005,B41,B42,B44(
12),B45(12),B46,B4
7,B48,B49(21),B5,B
50(21),B51(5),B510
2,B5103,B52(5),B53
,B54(22),B55(22),B5
6(22),B57(17),B58(1
7),B59,B60(40),B61(
40),B62(15),B63(15)
,B64(14),B65(14),B6
7,B7,B70,B703,B71(
70),B72(70),B73,B7
5(15),B76(15),B77(1
5),B78,B8,B81,B82,
BX
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Specificity – 1st antigen
B12,B13,B14,B15,B16,B17,B18,B21,B22,B27,B2708,B35,B
37,B38(16),B39(16),B3901,B3902,B40,B4005,B41,B42,B4
4(12),B45(12),B46,B47,B48,B49(21),B5,B50(21),B51(5),B5
102,B5103,B52(5),B53,B54(22),B55(22),B56(22),B57(17),
B58(17),B59,B60(40),B61(40),B62(15),B63(15),B64(14),B6
5(14),B67,B7,B70,B703,B71(70),B72(70),B73,B75(15),B76
(15),B77(15),B78,B8,B81,B82,BX
Specificity – 2nd antigen
B12,B13,B14,B15,B16,B17,B18,B21,B22,B27,B2708,B35,B
37,B38(16),B39(16),B3901,B3902,B40,B4005,B41,B42,B4
4(12),B45(12),B46,B47,B48,B49(21),B5,B50(21),B51(5),B5
102,B5103,B52(5),B53,B54(22),B55(22),B56(22),B57(17),
B58(17),B59,B60(40),B61(40),B62(15),B63(15),B64(14),B6
5(14),B67,B7,B70,B703,B71(70),B72(70),B73,B75(15),B76
(15),B77(15),B78,B8,B81,B82,BX
Rationale for Information Collection
Update
Page 13 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Confirmation of
HLA Typing
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Confirmation of
HLA Typing
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
yes
yes
no
no
Current
Information
Collection Data
Element
Response
Option(s)
C Antigens.
Number of
antigens provided one,two
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
C Antigens. Number of antigens
provided
one,two
Specificity – 1st
antigen
Cw1,Cw10(W3),Cw
2,Cw3,Cw4,Cw5,Cw
6,Cw7,Cw8,Cw9(W
3),CX
Specificity – 1st antigen
Cw1,Cw10(W3),Cw2,Cw3,Cw4,Cw5,Cw6,Cw7,Cw8,Cw9(
W3),CX
Specificity – 2nd antigen
Cw1,Cw10(W3),Cw2,Cw3,Cw4,Cw5,Cw6,Cw7,Cw8,Cw9(
W3),CX
yes
no
Specificity – 2nd
antigen
Cw1,Cw10(W3),Cw
2,Cw3,Cw4,Cw5,Cw
6,Cw7,Cw8,Cw9(W
3),CX
yes
no
Specificity Bw4
present?
no,yes
Specificity Bw4 present?
no,yes
yes
no
Specificity Bw6
present?
no,yes
Specificity Bw6 present?
no,yes
DR Antigens. Number of antigens
provided
one,two
Specificity – 1st antigen
DR1,DR10,DR103,DR11(5),DR12(5),DR13(6),DR14(6),DR1
403,DR1404,DR15(2),DR16(2),DR17(3),DR18(3),DR2,DR3,
DR4,DR5,DR6,DR7,DR8,DR9,DRX
yes
yes
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
DR Antigens.
Number of
antigens provided one,two
DR1,DR10,DR103,D
R11(5),DR12(5),DR1
3(6),DR14(6),DR140
3,DR1404,DR15(2),
DR16(2),DR17(3),D
R18(3),DR2,DR3,DR
Specificity – 1st
4,DR5,DR6,DR7,DR8
antigen
,DR9,DRX
Rationale for Information Collection
Update
Page 14 of 41
Information
Collection
Domain SubType
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
DR1,DR10,DR103,D
R11(5),DR12(5),DR1
3(6),DR14(6),DR140
3,DR1404,DR15(2),
DR16(2),DR17(3),D
R18(3),DR2,DR3,DR
4,DR5,DR6,DR7,DR8
,DR9,DRX
Specificity – 2nd antigen
DR1,DR10,DR103,DR11(5),DR12(5),DR13(6),DR14(6),DR1
403,DR1404,DR15(2),DR16(2),DR17(3),DR18(3),DR2,DR3,
DR4,DR5,DR6,DR7,DR8,DR9,DRX
yes
no
Specificity – 2nd
antigen
yes
no
Specificity DR51
present?
no,yes
Specificity DR51 present?
no,yes
yes
no
Specificity DR52
present?
no,yes
Specificity DR52 present?
no,yes
yes
no
Specificity DR53
present?
no,yes
Specificity DR53 present?
no,yes
no
DQ Antigens.
Number of
antigens provided one,two
DQ Antigens. Number of antigens
provided
one,two
Specificity – 1st
antigen
DQ1,DQ2,DQ3,DQ4,
DQ5(1),DQ6(1),DQ7
(3),DQ8(3),DQ9(3),
DQX
Specificity – 1st antigen
DQ1,DQ2,DQ3,DQ4,DQ5(1),DQ6(1),DQ7(3),DQ8(3),DQ9(3
),DQX
Specificity – 2nd
antigen
DQ1,DQ2,DQ3,DQ4,
DQ5(1),DQ6(1),DQ7
(3),DQ8(3),DQ9(3),
DQX
Specificity – 2nd antigen
DQ1,DQ2,DQ3,DQ4,DQ5(1),DQ6(1),DQ7(3),DQ8(3),DQ9(3
),DQX
yes
yes
yes
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Rationale for Information Collection
Update
Page 15 of 41
Information
Collection
Domain SubType
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Confirmation of
HLA Typing
Hematopoietic
Cellular Transplant
(HCT) Infusion
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Non NMDP
Allogeneic or
syngeneic Donor /
Recipient or Non
NMDP Cord Blood
Unit Information
Current
Information
Collection Data
Element
Response
Option(s)
no
DP Antigens.
Number of
antigens provided one,two
no
Specificity – 1st
antigen
yes
no
Specificity – 2nd
antigen
no
no
HCT type (check
only one)
DPw1,DPw2,DPw3,
DPw4,DPw5,DPw6,
DPX
Allogeneic,
related,Allogeneic,
unrelated,Autologo
us
no
no
Product type
(check only one)
no
no
no
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
DP Antigens. Number of antigens
provided
one,two
Specificity – 1st antigen
DPw1,DPw2,DPw3,DPw4,DPw5,DPw6,DPX
Specificity – 2nd antigen
DPw1,DPw2,DPw3,DPw4,DPw5,DPw6,DPX
HCT type (check only one)
Allogeneic, related,Allogeneic, unrelated,Autologous
Bone marrow,Other
product,PBSC,Single
cord blood unit
Product type
Bone marrow,Other product,PBSC,Single cord blood unit
Specify:
open text
Specify:
open text
no
NMDP Product
No,Yes
NMDP Product
No,Yes
no
no
NMDP cord blood
unit ID:
open text
NMDP cord blood unit ID:
open text
no
no
NMDP donor ID:
open text
NMDP donor ID:
open text
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
DPw1,DPw2,DPw3,
DPw4,DPw5,DPw6,
DPX
Rationale for Information Collection
Update
Page 16 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
no
no
Registry donor ID: open text
Registry donor ID:
open text
no
no
Non-NMDP cord
blood unit ID:
Non-NMDP cord blood unit ID:
open text
no
no
Global Registration
Identifier for
Donors (GRID)
open text
Global Registration Identifier for
Donors (GRID)
open text
no
no
ISBT DIN:
ISBT DIN:
no
no
Registry or UCB
Bank ID
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
open text
open text
(A) Austrian Bone
Marrow
Donors,(ACB)
Austrian Cord Blood
Registry,(ACCB)
StemCyte, Inc,(AE)
Emirates Bone
Marrow Donor
Registry,(AM)
Armenian Bone
Marrow Donor
Registry Charitable
Trust,(AOCB)
University of
Colorado Cord
Blood Bank,(AR)
Argentine CPH
Donors
Registry,(ARCB)
BANCEL - Argentina
Cord Blood
Bank,(AUCB)
Australian Cord
Blood
Registry,(AUS)
Australian / New
Zealand Bone
Marrow Donor
Registry,(B) Marrow
Registry or UCB Bank ID
Rationale for Information Collection
Update
open text
(A) Austrian Bone Marrow Donors,(ACB) Austrian Cord
Blood Registry,(ACCB) StemCyte, Inc,(AE) Emirates Bone
Marrow Donor Registry,(AM) Armenian Bone Marrow
Donor Registry Charitable Trust,(AOCB) University of
Colorado Cord Blood Bank,(AR) Argentine CPH Donors
Registry,(ARCB) BANCEL - Argentina Cord Blood
Bank,(AUCB) Australian Cord Blood Registry,(AUS)
Australian / New Zealand Bone Marrow Donor
Registry,(B) Marrow Donor Program Belgium,(BCB)
Belgium Cord Blood Registry,(BG) Bulgarian Bone Marrow
Donor Registry,(BR) INCA/REDOMO,(BSCB) British Bone
Marrow Registry - Cord Blood,(CB) Cord Blood
Registry,(CH) Swiss BloodStem Cells - Adult
Donors,(CHCB) Swiss Blood Stem Cells - Cord
Blood,(CKCB) Celgene Cord Blood Bank,(CN) China
Marrow Donor Program (CMDP),(CNCB) Shan Dong Cord
Blood Bank,(CND) Canadian Blood Services Bone Marrow
Donor Registry,(CS2) Czech National Marrow Donor
Registry,(CSCR) Czech Stem Cells Registry,(CY) Cyprus
Paraskevaidio Bone Marrow Donor Registry,(CY2) The
Cyprus Bone Marrow Donor Registry,(D) ZKRD - Zentrales
Knochenmarkspender - Register Deutschland Adult
Donors,(DCB) ZKRD - Zentrales Knochenmarkspender Register Deutschland Cord Blood,(DK) The Danish Bone
Marrow Donor Registry,(DK2) Bone Marrow Donors
Copenhagen (BMDC),(DUCB) German Branch of the
European Cord Blood Bank,(E) REDMO,(ECB) Spanish
Cord Blood Registry,(F) France Greffe de Moelle - Adult
Donors,(FCB) France Greffe de Moelle - Cord Blood,(FI)
Page 17 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Allogeneic Donors
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Allogeneic Donors
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Allogeneic Donors
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
no
no
no
yes
Current
Information
Collection Data
Element
Response
Option(s)
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Donor DOB:
YYYY/MM/DD
Donor DOB:
YYYY/MM/DD
Donor age:
open text, check
"Months" or check
"Years"
Donor age:
open text, check "Months" or check "Years"
no
Donor sex
open text, check
"Months" or check
"Years"
Donor sex
open text, check "Months" or check "Years"
no
Did the donor
receive growth and
mobilizing factors,
prior to any stem
cell harvest, to
enhance the
product collection
for this HCT?
No,Yes
Did the donor receive growth and
mobilizing factors, prior to any stem
cell harvest, to enhance the product
collection for this HCT?
No,Yes
Specify growth and mobilizing
factor(s) (check all that apply)
G-CSF (filgrastim, Neupogen),Pegylated GCSF(pegfilgrastim, Neulasta) , Plerixafor (Mozobil) Other
growth or mobilizing factor(s)
Specify other growth or mobilizing
factor(s):
open text
Date of first collection for this
mobilization:
YYYY/MM/DD
no
no
yes
no
yes
no
G-CSF (filgrastim,
Neupogen),Pegylat
ed GCSF(pegfilgrastim,
Specify growth and Neulasta) ,
mobilizing factor(s) Plerixafor (Mozobil)
(check all that
Other growth or
apply)
mobilizing factor(s)
Specify other
growth or
mobilizing
factor(s):
open text
no
Date of first
collection for this
mobilization:
no
Information Collection update:
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
YYYY/MM/DD
Rationale for Information Collection
Update
Page 18 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
no
Were
anticoagulants or
other agents added
to the product
between collection
and infusion?
No,Yes
Were anticoagulants or other agents
added to the product between
collection and infusion?
No,Yes
no
no
Acid citrate
dextrose (ACD, ACDA), Citrate
phosphate dextrose
Specify
(CPD, CPD-A),
anticoagulant(s) or Ethylenediaminetet
other agents
raacetic acid
(check all that
(EDTA), Heparin,
apply)
Other agent
Specify anticoagulant(s) or other
agents (check all that apply)
Acid citrate dextrose (ACD, ACD-A), Citrate phosphate
dextrose (CPD, CPD-A), Ethylenediaminetetraacetic acid
(EDTA), Heparin, Other agent
no
no
open text
Specify other agent:
open text
no
no
Specify other
agent:
Was this product
collected off-site
and shipped to
your facility?
no,yes
Was this product collected off-site
and shipped to your facility?
no,yes
no
Date of receipt of
product at your
facility:
Date of receipt of product at your
facility:
YYYY/MM/DD
no
Time of receipt of
product (24-hour
clock):
Time of receipt of product (24-hour
clock):
Hour:Minute Check standard time or check daylight
savings
no
Room temperature,
Cooled (refrigerator
temperature, not
Specify the
frozen), Frozen
shipping
(cyropreserved),
environment of the Other shipping
Change/Clarification of Response
product(s)
enfivronment
Options
Specify the shipping environment of
the product(s)
Room temperature, Cooled (refrigerated gel pack,
refrigerator temperature, not frozen), Frozen
(cyropreserved), Other shipping enfivronment
no
no
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
YYYY/MM/DD
Hour:Minute Check
standard time or
check daylight
savings
Rationale for Information Collection
Update
Examples added or typographical errors
corrected for clarification
Page 19 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
no
no
Current
Information
Collection Data
Element
Response
Option(s)
no
Specify other
shipping
environment:
no
Was there any
indication that the
environment
within the shipper
was outside the
expected
temperature range
for this product at
any time during
shipment?
no,yes
open text
no
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Were the
secondary
containers (e.g.,
insulated shipping
containers and unit
cassette) intact
when they arrived
at your center?
no,yes
Was the cord blood
unit stored at your
center prior to
thawing?
no,yes
Electric
Specify the storage freezer,Liquid
method used for
nitrogen,Vapor
the cord blood unit phase
< -150 0C , > -150
0C to < -135 0C , > Temperature
135 0C to < -80 0C,
during storage
> -80 0C
no
no
Date storage
started:
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
YYYY/MM/DD
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Specify other shipping environment:
open text
Was there any indication that the
environment within the shipper was
outside the expected temperature
range for this product at any time
during shipment?
no,yes
Rationale for Information Collection
Update
Were the secondary containers (e.g.,
insulated shipping containers and unit
cassette) intact when they arrived at
your center?
no,yes
Was the cord blood unit stored at
your center prior to thawing?
no,yes
Specify the storage method used for
the cord blood unit
Electric freezer,Liquid nitrogen,Vapor phase
Temperature during storage
< -150 0C , > -150 0C to < -135 0C , > -135 0C to < -80 0C,
> -80 0C
Date storage started:
YYYY/MM/DD
Page 20 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Cord Blood Product
Infusion
yes
no
Total nucleated
cells: (Includes
nucleated red and
nucleated white
cells)
Cord Blood Product
Infusion
yes
no
CD34+ cells
Current
Information
Collection Data
Element
Response
Option(s)
Total nucleated cells: (Includes
nucleated red and nucleated white
cells)
Done,Not done
CD34+ cells
_ _ _ _ . __ __ x 10
__ __
no
no
no
Total number of
CD34+ cells:
Was the product
thawed from a
cryopreserved
state prior to
infusion?
no
no
Was the entire
product thawed?
no
Specify the percent
of the product that
was thawed? (Cord 20%,80%,Other
Blood units only) percent
Cord Blood Product
Infusion
yes
no
Specify other
percent:
no
no
Date thawing
process initiated:
no
Hour:Minute Check
Time at initiation of "standard time" or
thaw (24-hour
"check daylight
clock):
savings time"
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
_ _ _ _ . __ __ x 10
__ __ (Includes
nucleated red and
nucleated white
cells) (Cord blood
units only)
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
Information Collection update:
Rationale for Information Collection
Update
_ _ _ _ . __ __ x 10 __ __ (Includes nucleated red and
nucleated white cells) (Cord blood units only)
Done,Not done
_ _ _ _ . __ __ x 10 __ __
Total number of CD34+ cells:
no,yes
Was the product thawed from a
cryopreserved state prior to infusion? no,yes
no,yes
Was the entire product thawed?
no,yes
Specify the percent of the product
that was thawed? (Cord Blood units
only)
20%,80%,Other percent
_ _%
_ _%
Specify other percent:
YYYY/MM/DD
Date thawing process initiated:
YYYY/MM/DD
Time at initiation of thaw (24-hour
clock):
Hour:Minute Check "standard time" or "check daylight
savings time"
Page 21 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Hour:Minute Check
"standard time" or
"check daylight
savings time"
no
Time of thaw
completion:
no
no
What method was Electric
used to thaw the warmer,Other
product?
method,Waterbath
no
no
no
no
no
Specify other
method:
open text
Did any incidents
or product
complaints occur
while preparing or
thawing the
product?
No,Yes
no
no
no
no
Was the product
processed prior to
infusion?
No,Yes
Buffy coat enriched
(buffy coat
preparation)
Specify processing ,Diluted,Plasma
(check all that
reduced,RBC
apply)
reduced,Washed
no
Was the product
manipulated prior
to infusion?
no,yes
no
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Specify
manipulations
performed (check
all that apply)
CD34 enriched
(CD34+ selection),
Ex-vivo expansion,
Ex-vivo T-cell
depetion, Genetic
manipulation (gene
transfer /
transuction), Other
cell manipulation
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Time of thaw completion:
Hour:Minute Check "standard time" or "check daylight
savings time"
What method was used to thaw the
product?
Electric warmer,Other method,Waterbath
Specify other method:
open text
Did any incidents or product
complaints occur while preparing or
thawing the product?
No,Yes
Was the product processed prior to
infusion?
No,Yes
Specify processing (check all that
apply)
Buffy coat enriched (buffy coat preparation)
,Diluted,Plasma reduced,RBC reduced,Washed
Rationale for Information Collection
Update
Was the product manipulated prior to
infusion?
no,yes
Specify manipulations performed
(check all that apply)
CD34 enriched (CD34+ selection), Ex-vivo expansion, Exvivo T-cell depetion, Genetic manipulation (gene transfer
/ transuction), Other cell manipulation
Page 22 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
no
no
Alpha/beta
antibody,Anti
CD19,Anti CD3,Anti
CD4,Anti
Specify antibodies CD45RA,Anti
used (check all that CD52,Anti
apply)
CD8,Other antibody
no
no
Specify other
antibody:
no
no
Antibody affinity
column,Immunoma
Specify T-cell
gnetic beads,Other
depletion method Method
Specify T-cell depletion method
Antibody affinity column,Immunomagnetic beads,Other
Method
no
no
Specify other
method:
open text
Specify other method:
open text
no
no
Specify other cell
manipulation:
open text
Specify other cell manipulation:
open text
no
yes
Specify the
timepoint in the
product
preparation phase
that the product
was analyzed
Product arrival
(cord blood only) ,
At infusion (final
quantity infused)
Specify the timepoint in the product
preparation phase that the product
was analyzed
Product arrival (cord blood only) , At infusion (final
quantity infused)
no
yes
Date of product
analysis:
YYYY/MM/DD
Date of product analysis:
YYYY/MM/DD
no
yes
Total volume of
product plus
additives:
no
yes
Total nucleated
cells (TNC)
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
open text
_ _ _ _ _ . _ ml
Done,Not done
Specify antibodies used (check all that Alpha/beta antibody,Anti CD19,Anti CD3,Anti CD4,Anti
apply)
CD45RA,Anti CD52,Anti CD8,Other antibody
Specify other antibody:
open text
Total volume of product plus
additives:
Total nucleated cells (TNC)
Rationale for Information Collection
Update
_ _ _ _ _ . _ ml
Done,Not done
Page 23 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
no
yes
Total nucleated
cells:
no
yes
Viability of TNC
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
_ _ _ _ . __ __ x 10
__ __
_ _ _ _ . __ __ x 10 __ __
Total nucleated cells:
Done,Not
done,Unknown
Viability of TNC
___%
Viability of TNC:
no
yes
Flow cytometry
based,Other
Method of testing method,Trypan
TNC viability
blue
no
yes
Specify other
method:
no
yes
Nucleated white
blood cells
no
yes
Total number of
nucleated white
blood cells:
no
yes
Mononuclear cells Done,Not done
Mononuclear cells
no
yes
_ _ _ _ . __ __ x 10
Total number of
__ __
mononuclear cells:
Total number of mononuclear cells:
no
yes
Nucleated red
blood cells
Nucleated red blood cells
yes
Total number of
nucleated red
blood cells:
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Done,Not done,Unknown
___%
yes
no
Rationale for Information Collection
Update
Viability of TNC:
Method of testing TNC viability
Flow cytometry based (7AAD, AOPI, AOEB),Other
method,Trypan blue
open text
Specify other method:
open text
Done,Not done
Nucleated white blood cells
Done,Not done
_ _ _ _ . __ __ x 10
__ __
Done,Not done
_ _ _ _ . __ __ x 10
__ __
Change/Clarification of Response
Options
Total number of nucleated white
blood cells:
Examples added or typographical errors
corrected for clarification
_ _ _ _ . __ __ x 10 __ __
Done,Not done
_ _ _ _ . __ __ x 10 __ __
Total number of nucleated red blood
cells:
Done,Not done
_ _ _ _ . __ __ x 10 __ __
Page 24 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
yes
CD34+ cells
no
yes
Total number of
CD34+ cells:
no
yes
Viability of CD34+
cells
yes
Viability of CD34+
cells:
no
yes
Flow cytometry
based,Other
Method of testing method,Trypan
CD34+ cell viability blue
no
yes
Specify other
method:
open text
Specify other method:
open text
no
yes
CD3+ cells
Done,Not done
CD3+ cells
Done,Not done
no
yes
Viability of CD3+
cells
Done,Not
done,Unknown
Viability of CD3+ cells
Done,Not done,Unknown
no
yes
Total number of
CD3+ cells:
no
yes
Viability of CD3+
cells:
yes
Flow cytometry
based,Other
Method of testing method,Trypan
CD3+ cell viability blue
no
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Done,Not done
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
CD34+ cells
_ _ _ _ . __ __ x 10
__ __
Rationale for Information Collection
Update
Done,Not done
_ _ _ _ . __ __ x 10 __ __
Total number of CD34+ cells:
Done,Not
done,Unknown
Viability of CD34+ cells
_ _ _%
Done,Not done,Unknown
_ _ _%
Viability of CD34+ cells:
Change/Clarification of Response
Options
Flow cytometry based (7AAD, AOPI, AOEB), Other
Method of testing CD34+ cell viability method,Trypan blue
_ _ _ _ . __ __ x 10
__ __
Examples added or typographical errors
corrected for clarification
_ _ _ _ . __ __ x 10 __ __
Total number of CD3+ cells:
_ _ _%
_ _ _%
Viability of CD3+ cells:
Change/Clarification of Response
Options
Method of testing CD3+ cell viability
Flow cytometry based (7AAD, AOPI, AOEB), Other
method,Trypan blue
Examples added or typographical errors
corrected for clarification
Page 25 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
no
yes
Specify other
method:
open text
Specify other method:
open text
no
yes
CD3+CD4+ cells
Done,Not done
CD3+CD4+ cells
Done,Not done
no
yes
Total number of
CD3+CD4+ cells:
no
yes
Viability of
CD3+CD4+ cells
yes
Viability of
CD3+CD4+ cells:
no
yes
Flow cytometry
Method of testing based,Other
CD3+CD4+ cell
method,Trypan
viability
blue
no
yes
Specify other
method:
no
yes
CD3+CD8+ cells
no
yes
Total number of
CD3+CD8+ cells:
no
yes
Viability of
CD3+CD8+ cells
no
yes
Viability of
CD3+CD8+ cells:
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
_ _ _ _ . __ __ x 10
__ __
Rationale for Information Collection
Update
_ _ _ _ . __ __ x 10 __ __
Total number of CD3+CD4+ cells:
Done,Not
done,Unknown
Viability of CD3+CD4+ cells
_ _ _%
Done,Not done,Unknown
_ _ _%
Viability of CD3+CD4+ cells:
Change/Clarification of Response
Options
Method of testing CD3+CD4+ cell
viability
Flow cytometry based (7AAD, AOPI, AOEB), Other
method,Trypan blue
open text
Specify other method:
open text
Done,Not done
CD3+CD8+ cells
Done,Not done
_ _ _ _ *_ _ x 10 _ _
Examples added or typographical errors
corrected for clarification
_ _ _ _ *_ _ x 10 _ _
Total number of CD3+CD8+ cells:
Done,Not
done,Unknown
Viability of CD3+CD8+ cells
_ _ _%
Done,Not done,Unknown
_ _ _%
Viability of CD3+CD8+ cells:
Page 26 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Infusion
Product
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Rationale for Information Collection
Update
Change/Clarification of Response
Options
Method of testing CD3+CD8+ cell
viability
Flow cytometry based (7AAD, AOPI, AOEB), Other
method,Trypan blue
Examples added or typographical errors
corrected for clarification
Specify other method:
open text
no
yes
Flow cytometry
Method of testing based,Other
CD3+CD8+ cell
method,Trypan
viability
blue
no
yes
Specify other
method:
Cord Blood Product
Infusion
yes
yes
Were the colonyforming units (CFU)
assessed after
thawing? (cord
blood units only) no,yes
Were the colony-forming units (CFU)
assessed after thawing? (cord blood
units only)
no,yes
Cord Blood Product
Infusion
yes
yes
Was there growth? no,yes
Was there growth?
Total CFU-GM
Indicate which Assessments were
Carried out (Check all that apply)
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
yes
open text
Done,Not done
Merged to Check all that Apply
_ _ _ _ _.__x10__
__
yes
yes
Total CFU-GM:
Done,Not done
Merged to Check all that Apply
Total CFU-GEMM
_ _ _ _ _.__x10__
__
yes
yes
Total CFU-GEMM:
Done,Not done
Merged to Check all that Apply
Total BFU-E
_ _ _ _ _.__x10__
__
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Total BFU-E:
Done,Not done
Reduce burden: expanded response options
to include responses previously reported
manually or created a "check all that apply"
_ _ _ _ _.__x10__ __
Total CFU-GEMM:
Total BFU-E
Total CFU-GM, Total CFU-GEMM, Total BFU-E
Reduce burden: expanded response options
to include responses previously reported
manually or created a "check all that apply"
_ _ _ _ _.__x10__ __
Total CFU-GM:
Total CFU-GEMM
no,yes
Done,Not done
Reduce burden: expanded response options
to include responses previously reported
manually or created a "check all that apply"
_ _ _ _ _.__x10__ __
Total BFU-E:
Page 27 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
no
yes
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Product Analysis
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Were any positive
cultures (for
bacterial or fungal
infections)
obtained from the
product at the
transplant center?
(complete for all
No,Pending,Unkno
cell products)
wn,Yes
Bacterial Infections:
121 inetobacter (all
species), 125
Bordetella pertussis
(whooping cough),
128 Campylobacter
(all species), 129
Capnocytophaga
(all species), 171
Chlamydia
(pneumoniae), 130
Citrobacter
(freundii, other
species), 131
Clostridium (all
species except
difficile), 132
Clostridium difficile,
173
Corynebacterium
jeikeium, 134
Enterobacter (all
species), 135
Enterococcus (all
species), 177
Enterococcus,
vancomycin
Specify Organism resistant (VRE), 136 Change/Clarification of Response
Code(s):
Escherichia (also E. Options
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Were any positive cultures (for
bacterial or fungal infections)
obtained from the product at the
transplant center? (complete for all
cell products)
Specify Organism Code(s):
Rationale for Information Collection
Update
No,Pending,Unknown,Yes
Bacterial Infections: 121 inetobacter (all species), 125
Bordetella pertussis (whooping cough), 128
Campylobacter (all species), 129 Capnocytophaga (all
species), 171 Chlamydia (pneumoniae), 130 Citrobacter
(freundii, other species), 131 Clostridium (all species
except difficile), 132 Clostridium difficile, 173
Corynebacterium jeikeium, 134 Enterobacter (all species),
135 Enterococcus (all species), 177 Enterococcus,
vancomycin resistant (VRE), 136 Escherichia (also E. coli),
139 Fusobacterium (all species), 187 Haemophilus
influenzae, 188 Haemophilus non-influenzae, 146
Klebsiella (all species), 147 Lactobacillus (bulgaricus,
acidophilus, other species), 189 Legionella pneumophila,
190 Legionella non-pneumophila, 103 Leptospira (all
species), 148 Leptotrichia buccalis, 149 Leuconostoc (all
species), 104 Listeria monocytogenes, 151 Micrococcus,
NOS, 118 Mycobacterium abscessus, 112 Mycobacterium
avium - intracellulare (MAC, MAI), 108 Mycobacterium
cheloneae, 109 Mycobacterium fortuitum, 114
Mycobacterium haemophilum, 115 Mycobacterium
kansasii, 116 Mycobacterium marinum, 117
Mycobacterium mucogenicum, 110 Mycobacterium
tuberculosis (tuberculosis, Koch bacillus), 105
Mycoplasma (all species), 183 Neisseria gonorrhoeae, 184
Neisseria meningitidis, 106 Nocardia (all species), 153
Pasteurella multocida, 155 Proteus (all species), 157
Pseudomonas or Burkholderia cepacia, 185 Pseudomonas
aeruginosa, 186 Pseudomonas non-aeruginosa, 159
Examples added or typographical errors
Rhodococcus (all species), 107 Rickettsia (all species), 160 corrected for clarification
Page 28 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Product Analysis
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Specify Organism
Code(s):
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Bacterial Infections:
121 inetobacter (all
species), 125
Bordetella pertussis
(whooping cough),
128 Campylobacter
(all species), 129
Capnocytophaga
(all species), 171
Chlamydia
(pneumoniae), 130
Citrobacter
(freundii, other
species), 131
Clostridium (all
species except
difficile), 132
Clostridium difficile,
173
Corynebacterium
jeikeium, 134
Enterobacter (all
species), 135
Enterococcus (all
species), 177
Enterococcus,
vancomycin
resistant (VRE), 136 Change/Clarification of Response
Escherichia (also E. Options
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Bacterial Infections: 121 inetobacter (all species), 125
Specify Organism Code(s):
Rationale for Information Collection
Update
Bordetella pertussis (whooping cough), 128
Campylobacter (all species), 129 Capnocytophaga (all
species), 171 Chlamydia (pneumoniae), 130 Citrobacter
(freundii, other species), 131 Clostridium (all species
except difficile), 132 Clostridium difficile, 173
Corynebacterium jeikeium, 134 Enterobacter (all species),
135 Enterococcus (all species), 177 Enterococcus,
vancomycin resistant (VRE), 136 Escherichia (also E. coli),
139 Fusobacterium (all species), 187 Haemophilus
influenzae, 188 Haemophilus non-influenzae, 146
Klebsiella (all species), 147 Lactobacillus (bulgaricus,
acidophilus, other species), 189 Legionella pneumophila,
190 Legionella non-pneumophila, 103 Leptospira (all
species), 148 Leptotrichia buccalis, 149 Leuconostoc (all
species), 104 Listeria monocytogenes, 151 Micrococcus,
NOS, 118 Mycobacterium abscessus, 112 Mycobacterium
avium - intracellulare (MAC, MAI), 108 Mycobacterium
cheloneae, 109 Mycobacterium fortuitum, 114
Mycobacterium haemophilum, 115 Mycobacterium
kansasii, 116 Mycobacterium marinum, 117
Mycobacterium mucogenicum, 110 Mycobacterium
tuberculosis (tuberculosis, Koch bacillus), 105
Mycoplasma (all species), 183 Neisseria gonorrhoeae, 184
Neisseria meningitidis, 106 Nocardia (all species), 153
Pasteurella multocida, 155 Proteus (all species), 157
Pseudomonas or Burkholderia cepacia, 185 Pseudomonas
aeruginosa, 186 Pseudomonas non-aeruginosa, 159
Examples added or typographical errors
Rhodococcus (all species), 107 Rickettsia (all species), 160 corrected for clarification
Page 29 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Product Analysis
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Specify Organism
Code(s):
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Bacterial Infections:
121 inetobacter (all
species), 125
Bordetella pertussis
(whooping cough),
128 Campylobacter
(all species), 129
Capnocytophaga
(all species), 171
Chlamydia
(pneumoniae), 130
Citrobacter
(freundii, other
species), 131
Clostridium (all
species except
difficile), 132
Clostridium difficile,
173
Corynebacterium
jeikeium, 134
Enterobacter (all
species), 135
Enterococcus (all
species), 177
Enterococcus,
vancomycin
resistant (VRE), 136 Change/Clarification of Response
Escherichia (also E. Options
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Bacterial Infections: 121 inetobacter (all species), 125
Specify Organism Code(s):
Rationale for Information Collection
Update
Bordetella pertussis (whooping cough), 128
Campylobacter (all species), 129 Capnocytophaga (all
species), 171 Chlamydia (pneumoniae), 130 Citrobacter
(freundii, other species), 131 Clostridium (all species
except difficile), 132 Clostridium difficile, 173
Corynebacterium jeikeium, 134 Enterobacter (all species),
135 Enterococcus (all species), 177 Enterococcus,
vancomycin resistant (VRE), 136 Escherichia (also E. coli),
139 Fusobacterium (all species), 187 Haemophilus
influenzae, 188 Haemophilus non-influenzae, 146
Klebsiella (all species), 147 Lactobacillus (bulgaricus,
acidophilus, other species), 189 Legionella pneumophila,
190 Legionella non-pneumophila, 103 Leptospira (all
species), 148 Leptotrichia buccalis, 149 Leuconostoc (all
species), 104 Listeria monocytogenes, 151 Micrococcus,
NOS, 118 Mycobacterium abscessus, 112 Mycobacterium
avium - intracellulare (MAC, MAI), 108 Mycobacterium
cheloneae, 109 Mycobacterium fortuitum, 114
Mycobacterium haemophilum, 115 Mycobacterium
kansasii, 116 Mycobacterium marinum, 117
Mycobacterium mucogenicum, 110 Mycobacterium
tuberculosis (tuberculosis, Koch bacillus), 105
Mycoplasma (all species), 183 Neisseria gonorrhoeae, 184
Neisseria meningitidis, 106 Nocardia (all species), 153
Pasteurella multocida, 155 Proteus (all species), 157
Pseudomonas or Burkholderia cepacia, 185 Pseudomonas
aeruginosa, 186 Pseudomonas non-aeruginosa, 159
Examples added or typographical errors
Rhodococcus (all species), 107 Rickettsia (all species), 160 corrected for clarification
Page 30 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Product Analysis
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Bacterial Infections:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Bacterial Infections: 121 inetobacter (all species), 125
yes
yes
Specify Organism
Code(s):
121 inetobacter (all
species), 125
Bordetella pertussis
(whooping cough),
128 Campylobacter
(all species), 129
Capnocytophaga
(all species), 171
Chlamydia
(pneumoniae), 130
Citrobacter
(freundii, other
species), 131
Clostridium (all
species except
difficile), 132
Clostridium difficile,
173
Corynebacterium
jeikeium, 134
Enterobacter (all
species), 135
Enterococcus (all
species), 177
Enterococcus,
vancomycin
resistant (VRE), 136 Change/Clarification of Response
Escherichia (also E. Options
no
yes
Specify organism:
open text
Specify organism:
open text
no
yes
Date of this
product infusion:
YYYY/MM/DD
Date of this product infusion:
YYYY/MM/DD
Was the entire volume of received
product infused?
no,yes
Specify what happened to the
reserved portion
cryopreserved for future use,discarded,other fate
no
yes
no
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Was the entire
volume of received
product infused? no,yes
cryopreserved for
Specify what
future
happened to the
use,discarded,other
reserved portion fate
Rationale for Information Collection
Update
Specify Organism Code(s):
Bordetella pertussis (whooping cough), 128
Campylobacter (all species), 129 Capnocytophaga (all
species), 171 Chlamydia (pneumoniae), 130 Citrobacter
(freundii, other species), 131 Clostridium (all species
except difficile), 132 Clostridium difficile, 173
Corynebacterium jeikeium, 134 Enterobacter (all species),
135 Enterococcus (all species), 177 Enterococcus,
vancomycin resistant (VRE), 136 Escherichia (also E. coli),
139 Fusobacterium (all species), 187 Haemophilus
influenzae, 188 Haemophilus non-influenzae, 146
Klebsiella (all species), 147 Lactobacillus (bulgaricus,
acidophilus, other species), 189 Legionella pneumophila,
190 Legionella non-pneumophila, 103 Leptospira (all
species), 148 Leptotrichia buccalis, 149 Leuconostoc (all
species), 104 Listeria monocytogenes, 151 Micrococcus,
NOS, 118 Mycobacterium abscessus, 112 Mycobacterium
avium - intracellulare (MAC, MAI), 108 Mycobacterium
cheloneae, 109 Mycobacterium fortuitum, 114
Mycobacterium haemophilum, 115 Mycobacterium
kansasii, 116 Mycobacterium marinum, 117
Mycobacterium mucogenicum, 110 Mycobacterium
tuberculosis (tuberculosis, Koch bacillus), 105
Mycoplasma (all species), 183 Neisseria gonorrhoeae, 184
Neisseria meningitidis, 106 Nocardia (all species), 153
Pasteurella multocida, 155 Proteus (all species), 157
Pseudomonas or Burkholderia cepacia, 185 Pseudomonas
aeruginosa, 186 Pseudomonas non-aeruginosa, 159
Examples added or typographical errors
Rhodococcus (all species), 107 Rickettsia (all species), 160 corrected for clarification
Page 31 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
yes
Specify other fate: open text
no
yes
Time product
infusion initiated
(24-hour clock):
no
yes
Date infusion
stopped:
yes
Hour:Minute Check
Time product
"standard time" or
infusion completed "check daylight
(24-hour clock):
savings time"
Time product infusion completed (24- Hour:Minute Check "standard time" or "check daylight
hour clock):
savings time"
no
yes
Specify the route Intramedullary,Intra
of product infusion venous,Other route
(24-hour clock);
of infusion
Specify the route of product infusion
(24-hour clock);
Intramedullary,Intravenous,Other route of infusion
no
yes
Specify other route
of infusion:
open text
Specify other route of infusion:
open text
Cord Blood Product
Infusion
yes
no
Were there any
adverse events or
incidents
associated with the
stem cell infusion? no,yes
Were there any adverse events or
incidents associated with the stem
cell infusion?
no,yes
Cord Blood Product
Infusion
yes
no
Brachycardia
no,yes
no
no
Hematopoietic
Cellular Transplant
(HCT) Product
Cord Blood Product
Infusion
Infusion
yes
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Specify other fate:
open text
Hour:Minute Check
"standard time" or
"check daylight
savings time"
Time product infusion initiated (24hour clock):
Hour:Minute Check "standard time" or "check daylight
savings time"
YYYY/MM/DD
Date infusion stopped:
YYYY/MM/DD
Brachycardia
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Rationale for Information Collection
Update
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Page 32 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Hematopoietic
Cellular Transplant
(HCT) Product
Cord Blood Product
Infusion
Infusion
yes
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
no
no
no
Current
Information
Collection Data
Element
Response
Option(s)
Chest tightness /
pain
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Chills at time of
infusion
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Fever ≤ 103 °F
within 24 hours of
infusion
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Cord Blood Product
Infusion
yes
no
Fever > 103° F
within 24 hours of
infusion
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Cord Blood Product
Infusion
yes
no
Gross
hemoglobinuria
Cord Blood Product
Infusion
yes
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
no,yes
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Chest tightness / pain
Rationale for Information Collection
Update
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Chills at time of infusion
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Fever ≤ 103 °F within 24 hours of
infusion
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Fever > 103° F within 24 hours of
infusion
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Gross hemoglobinuria
no,yes
Page 33 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Current
Information
Collection Data
Element
Response
Option(s)
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Headache
Hives
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Hives
Hypertension
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Hypotension
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Hypotension
no,yes
Rationale for Information Collection
Update
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Headache
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Hypertension
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Information Collection update:
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
no,yes
no,yes
Page 34 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Cord Blood Product
Infusion
yes
Cord Blood Product
Infusion
yes
no
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Current
Information
Collection Data
Element
Response
Option(s)
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Hypoxia requiring
oxygen (O2)
support
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Nausea
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Cord Blood Product
Infusion
yes
no
Rigors, mild
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Cord Blood Product
Infusion
yes
no
Rigors, severe
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
no,yes
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Rationale for Information Collection
Update
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Hypoxia requiring oxygen (O2) support no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Nausea
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Rigors, mild
Rigors, severe
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
no,yes
Page 35 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Cord Blood Product
Infusion
yes
no
Current
Information
Collection Data
Element
Response
Option(s)
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Shortness of
breath (SOB)
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Shortness of breath (SOB)
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Tachycardia
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Tachycardia
Vomiting
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Cord Blood Product
Infusion
yes
no
Vomiting
no,yes
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Cord Blood Product
Infusion
yes
no
Other expected AE no,yes
Other expected AE
no,yes
Cord Blood Product
Infusion
yes
no
Specify other
expected AE:
Specify other expected AE:
open text
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
open text
Rationale for Information Collection
Update
no,yes
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Page 36 of 41
Information
Collection
Domain SubType
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Hematopoietic
Cellular Transplant
(HCT) Product
Infusion
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Cord Blood Product
Infusion
yes
no
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Cord Blood Product
Infusion
yes
no
Other unexpected
AE
no,yes
Cord Blood Product
Infusion
yes
no
Hematopoietic
Cellular Transplant
(HCT) Product
Cord Blood Product
Infusion
Infusion
yes
no
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Specify other
unexpected AE:
open text
In the Medical
Director's
judgment, was the
adverse event a
direct result of the
infusion?
no,yes
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Other unexpected AE
no,yes
Specify other unexpected AE:
open text
In the Medical Director's judgment,
was the adverse event a direct result
of the infusion?
no,yes
Was the donor
ever pregnant?
Not applicable
(male donor or cord
blood unit)
,No,Unknown,Yes
Was the donor ever pregnant?
Not applicable (male donor or cord blood unit)
,No,Unknown,Yes
no
Number of
pregnancies
Known,Unknown
Number of pregnancies
Known,Unknown
no
Specify number of
pregnancies:
open text
Specify number of pregnancies:
open text
Ethnicity (donor)
Hispanic or Latino,Not applicable (not a resident of the
USA),Not Hispanic or Latino,Unknown
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Ethnicity (donor)
Hispanic or
Latino,Not
applicable (not a
resident of the
USA),Not Hispanic
or Latino,Unknown
Rationale for Information Collection
Update
Page 37 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Current
Information
Collection Data
Element
Response
Option(s)
American Indian or
Alaska
Native,Asian,Black
or African
American,Not
reported,Native
Hawaiian or Other
Race (donor)
Pacific
(check all that
Islander,Unknown,
apply)
White
African
American,African
(both parents born
in Africa),South
Asian,American
Indian, South or
Central
America,Alaskan
Native or
Aleut,North
American
Indian,Black
Caribbean,Caribbea
n Indian,Other
White,Eastern
European,Filipino
(Pilipino),Guamania
n,Hawaiian,Japanes
e,Korean,Mediterra
nean,Middle
Eastern,North
American,North
Coast of
Africa,Chinese,Nort
hern
European,Other
Race detail (donor) Pacific
(check all that
Islander,Other
apply)
Black,Samoan,Black
Was the donor a
carrier for
potentially
transferable
genetic diseases? No,Yes
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Race (donor) (check all that apply)
American Indian or Alaska Native,Asian,Black or African
American,Not reported,Native Hawaiian or Other Pacific
Islander,Unknown,White
Race detail (donor) (check all that
apply)
African American,African (both parents born in
Africa),South Asian,American Indian, South or Central
America,Alaskan Native or Aleut,North American
Indian,Black Caribbean,Caribbean Indian,Other
White,Eastern European,Filipino
(Pilipino),Guamanian,Hawaiian,Japanese,Korean,Mediterr
anean,Middle Eastern,North American,North Coast of
Africa,Chinese,Northern European,Other Pacific
Islander,Other Black,Samoan,Black South or Central
American,Other Southeast
Asian,Unknown,Vietnamese,White Caribbean,Western
European,White South or Central American
Rationale for Information Collection
Update
Was the donor a carrier for potentially
transferable genetic diseases?
No,Yes
Page 38 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
no
Specify potentially
transferable
genetic disease
(check all that
apply)
Other
hemoglobinopathy,
Other disease,Sickle
cell
anemia,Thalassemia
Specify potentially transferable
genetic disease (check all that apply)
Other hemoglobinopathy,Other disease,Sickle cell
anemia,Thalassemia
no
Specify other
disease:
open text
Specify other disease:
open text
no
Was the donor /
product tested for
other transferable
genetic or clonal
abnormalities?
No,Unknown,Yes
Was the donor / product tested for
other transferable genetic or clonal
abnormalities?
No,Unknown,Yes
no
Clonal
hematopoiesis of
indeterminate
potential (CHIP)
No,Yes
Clonal hematopoiesis of
indeterminate potential (CHIP)
No,Yes
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
What was the
method of testing
used?
open text
What was the method of testing
used?
open text
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Monoclonal B-cell
lymphocytosis
No,Yes
Monoclonal B-cell lymphocytosis
No,Yes
no
Other transferable
genetic or clonal
abnormality
No,Yes
Other transferable genetic or clonal
abnormality
No,Yes
no
Specify other
transferable
genetic or clonal
abnormality:
Specify other transferable genetic or
clonal abnormality:
open text
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Non NMDP
Hematopoietic
Allogeneic Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
open text
Rationale for Information Collection
Update
Page 39 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
no
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Current
Information
Collection Data
Element
Response
Option(s)
Did this donor have
a central line
placed?
no,yes
Was the donor
hospitalized
(inpatient) during
or after the
collection?
no,yes
Did the donor
experience any lifethreatening
complications
during or after the
collection?
no,yes
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
Did this donor have a central line
placed?
no,yes
Was the donor hospitalized
(inpatient) during or after the
collection?
no,yes
Did the donor experience any lifethreatening complications during or
after the collection?
no,yes
Specify:
open text
no
Specify:
open text
Did the allogeneic
donor give one or
more autologous
transfusion units? No,Yes
Did the allogeneic donor give one or
more autologous transfusion units?
No,Yes
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Date of collection: YYYY/MM/DD
Date of collection:
YYYY/MM/DD
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
open text
Number of units:
open text
Allogeneic
transfusions,Autolo
gous
transfusions,No
Did the donor receive blood
transfusions as a result of the
collection?
Allogeneic transfusions,Autologous transfusions,No
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Number of units:
Did the donor
receive blood
transfusions as a
result of the
collection?
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Specify number of
autologous units: open text
Specify number of autologous units:
open text
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Specify number of
allogeneic units:
open text
Specify number of allogeneic units:
open text
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Rationale for Information Collection
Update
Page 40 of 41
Information
Collection
Domain SubType
Current
Information
Information
Information
Collection Domain Response required if Collection may be Collection Data
Additional Sub
Additional Sub Domain requested multiple Element (if
Domain
applies
times
applicable)
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
Current
Information
Collection Data
Element
Response
Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data Element
Data Element (if applicable)
Response Option(s)
no
Did the donor die
as a result of the
collection?
no,yes
Did the donor die as a result of the
collection?
no,yes
Hematopoietic
Allo Related Donor /
Cellular Transplant Infant Demographic
(HCT) Infusion
Information
yes
no
Specify cause of
death:
open text
Specify cause of death:
open text
Hematopoietic
Cellular Transplant
(HCT) Infusion
no
yes
First Name (person
completing form): open text
First Name (person completing form): open text
Hematopoietic
Cellular Transplant
(HCT) Infusion
no
yes
Last Name:
open text
Last Name:
open text
Hematopoietic
Cellular Transplant
(HCT) Infusion
no
yes
E-mail address:
open text
E-mail address:
open text
Hematopoietic
Cellular Transplant
(HCT) Infusion
no
yes
Date:
YYYY/MM/DD
Date:
YYYY/MM/DD
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Transplant Procedure&Produc
Rationale for Information Collection
Update
Page 41 of 41
| File Type | application/pdf |
| File Title | SCTOD Information Collection_to HRSA 2022-03-29.xlsx |
| Author | doleysh |
| File Modified | 2022-03-29 |
| File Created | 2022-03-29 |