Product Procedure Info Collection

5b - Product Procedure Info Collection_to HRSA 2022-03-29.pdf

Stem Cell Therapeutic Outcomes Database

Product Procedure Info Collection

OMB: 0915-0310

Document [pdf]
Download: pdf | pdf
Information 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 Typeapplication/pdf
File TitleSCTOD Information Collection_to HRSA 2022-03-29.xlsx
Authordoleysh
File Modified2022-03-29
File Created2022-03-29

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