3 Form_2004_R4+. Infectious Disease Markers

Stem Cell Therapeutic Outcomes Database

Form_2004_R4+. Infectious Disease Markers

Stem Cell Therapeutic Outcomes Database (Product Form)

OMB: 0915-0310

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2004: Infectious Disease Markers

Registry Use Only
Sequence Number:
Date Received:

Key Fields
OMB No: 0915-0310
Expiration Date: 1/31/2017
Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number. The OMB control number for this project is 0915-0310. Public reporting burden for this collection
of information is estimated to average 1.0 hours per response, including the time for reviewing instructions, searching existing data sources,
and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-29, Rockville,
Maryland, 20857.
CIBMTR Center Number: ___ ___ ___ ___ ___ 	
CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 	
Date of HCT for which this form is being completed: __ __ __ __ / __ __ / __ __	
		
YYYY
MM
DD	
HCT type (check only one)	 ☐ Allogeneic, unrelated	

☐ Allogeneic, related	

Product type (check all that apply)	 ☐ Bone marrow	
	
	
	

☐ PBSC	
☐ Single cord blood unit	
☐ Other product. Specify: ____________________________________________________________________

CIBMTR Form 2004 revision 4 (page 1 of 4). Last Updated October, 2013.
Copyright (c) 2013 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Donor/Cord Blood Unit Identification

Questions: 1-9

This form must be completed for all non-NMDP allogeneic or syngeneic donors, or non-NMDP cord blood units.

1.	

Specify non-NMDP donor	

	☐ Related donor		
	☐ Non-NMDP unrelated donor	
	☐ Non-NMDP unrelated cord blood unit

2.	
	

Non-NMDP unrelated donor ID: ___________________________________________
(not applicable for related donor)

3.	
	

Non-NMDP cord blood unit ID:_____________________________________________
(include related and autologous CBUs)	

	☐ Known	
	

5.	
	

Date of birth: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

	☐ Unknown	

6.	

Age (donor/infant)

		
(include related and autologous
		CBUs)	

4.	

Date of birth (donor/infant)

	☐ Known 	 7.	 Age: (donor/infant)___ ___	
	
☐ Unknown		 ☐ Months (use only if less than 1 year old)	

	
8.	

Sex (donor/infant)	 ☐ male	

9.	

Who is being tested for IDMs?

☐ female

	☐ donor IDM (marrow or PBSC)	

☐ maternal IDM (cord blood)	

☐ cord blood unit IDM	

Infectious Disease Marker (report final test results)
Hepatitis B Virus (HBV)
10.	 HBsAg: (hepatitis B surface antigen)

	☐ Reactive	
	☐ Non-reactive	
	☐ Not done	

11.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD

12.	 Anti HBc: (hepatitis B core antibody)

	☐ Reactive	
	☐ Non-reactive	
	☐ Not done

13.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD

	
Hepatitis C Virus (HCV)
14.	 Anti-HCV: (hepatitis C antibody)

	☐ Reactive	
	☐ Non-reactive	
	☐ Not done		

15.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

Human T-Lymphotropic Virus
16.	 Anti-HTLV I/II

	☐ Reactive	
	☐ Non-reactive	
	☐ Not done

☐ years	

17.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

CIBMTR Form 2004 revision 4 (page 2 of 4). Last Updated October, 2013.
Copyright (c) 2013 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

Questions: 10-46

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Human Immunodeficiency Virus (HIV)
18.	 HIV-1 p24 antigen

	☐ Reactive	
	☐ Non-reactive	
	☐ Not done	
	☐ Not reported	

19.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

	
20.	 Was FDA licensed NAT testing for HIV-1/HCV performed?

	☐ yes	
	☐ no	
	

Specify results:
21.	HIV-1

	☐ Positive	
	☐ Negative	
	☐ Not reported
23.	HCV

	☐ Positive	
	☐ Negative

22.	 Date sample collected:
	
	

__ __ __ __ / __ __ / __ __
YYYY
MM
DD

24.	 Date sample collected:
	
	

__ __ __ __ / __ __ / __ __
YYYY
MM
DD

	
25.	 Anti-HIV 1 and anti-HIV 2*: (antibodies to Human Immunodeficiency Viruses) *Testing for both HIV antibodies is required. This testing
	
may be performed as separate tests or done using a combined assay.

	☐ Reactive	
	☐ Non-reactive	
	☐ Not done	
	☐ Not reported	

26.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

Syphilis
27.	STS

	☐ Reactive	
	☐ Non-reactive	
	☐ Not done	

28.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

Cytomegalovirus (CMV)
29.	 Anti-CMV: (IgG or Total)

	☐ Reactive	
	☐ Non-reactive	
	☐ Not done	

30.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

West Nile Virus (WNV)
31.	 WNV-NAT testing

	☐ Positive	
	☐ Negative	
	☐ Not done	
	☐ Not applicable	

32.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

Chagas
33.	 Chagas testing

	☐ Positive
	☐ Negative
	☐ Not Done

34.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

	

CIBMTR Form 2004 revision 4 (page 3 of 4). Last Updated October, 2013.
Copyright (c) 2013 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Herpes simplex virus (HSV)
35.	 Anti-HSV (Herpes simplex virus antibody)

	☐ Positive	
	☐ Negative	
	☐ Not Done	

36.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

Epstein-Barr virus (EBV)
37.	 Anti-EBV (Epstein-Barr virus antibody)

	☐ Positive	
	☐ Negative	
	☐ Inconclusive	
	☐ Not done	

38.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

Varicella zoster virus (VZV)
39.	 Anti-VZV (Varicella zoster virus antibody)

	☐ Positive	
	☐ Negative	
	☐ Not Done	

40.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

Toxoplasmosis
41.	Toxoplasmosis

	☐ Positive	
	☐ Negative	
	☐ Not Done	

42.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	

	
Other Infectious Disease Marker
43.	 Other infectious disease marker

	☐ yes	
	☐ no	

44.	 Date sample collected: __ __ __ __ / __ __ / __ __
		
YYYY
MM
DD	
45.	 Specify test and method:_________________________________________________
46.	 Specify test results: _____________________________________________________
Copy questions 44 - 46 if needed for Other infectious disease marker

First Name:_____________________________________________________
Last Name:_____________________________________________________
E-mail address:__________________________________________________
Date: __ __ __ __ / __ __ / __ __
		 YYYY
MM
DD

CIBMTR Form 2004 revision 4 (page 4 of 4). Last Updated October, 2013.
Copyright (c) 2013 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.


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