1 Idm

Stem Cell Therapeutic Outcomes Database

2-FINAL 2004-Product Form (IDM) r4

Stem Cell Therapeutic Outcomes Database (Product Form)

OMB: 0915-0310

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___


R

OMB No: 0915-0310

Expiration Date: 12/31/2013


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, in combination with the HLA Typing Form 2005 and HCT Infusion Form 2006, is estimated to average 1.5 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 10-33, Rockville, Maryland, 20857.

Expiration date: 12/31/2013

egistry Use Only

Sequence Number:









Date Received:





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:

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




Donor / Cord Blood Unit Identification

  1. Specify non-NMDP donor:

 Related donor – Go to question 4

 Non-NMDP unrelated donor – Go to question 2

 Non-NMDP cord blood unit (include related and autologous CBUs) – Go to question 3

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

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 4

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

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

  1. Date of birth (donor / infant):

Known – Go to question 5

Unknown – Go to question 6

  1. Date of birth (donor / infant): ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 8

  2. Age (donor / infant):

Known – Go to question 7

Unknown – Go to question 8

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

Years

  1. Sex (donor / infant):

Male

Female

  1. Who is being tested for IDMs?

Donor IDM (bone marrow or PBSC)

Maternal IDM (cord blood)

Cord blood unit IDM







Infectious Disease Marker (report final test results)

Hepatitis B Virus (HBV)

  1. HBsAg: (hepatitis B surface antigen)

Reactive – Go to question 11

Non-reactive – Go to question 11

Not done – Go to question 12

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Anti HBc: (hepatitis B core antibody)

Reactive – Go to question 13

Non-reactive – Go to question 13

Not done – Go to question 14

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Hepatitis C Virus (HCV)

  1. Anti-HCV: (hepatitis C antibody)

Reactive – Go to question 15

Non-reactive – Go to question 15

Not done – Go to question 16

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Human T-Lymphotropic Virus

  1. Anti-HTLV I / II:

Reactive – Go to question 17

Non-reactive – Go to question 17

Not done – Go to question 18

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Human Immunodeficiency Virus (HIV)

  1. HIV-1 p24 antigen:

Reactive – Go to question 19

Non-reactive – Go to question 19

Not done – Go to question 20

Not reported – Go to question 20

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

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

Yes – Go to questions 21

No – Go to question 25

Specify results:

  1. HIV-1

Positive – Go to question 22

Negative – Go to question 22

Not reported – Go to question 23

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. HCV

Positive

Negative

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. 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 – Go to question 26

Non-reactive – Go to question 26

Not done – Go to question 27

Not reported – Go to question 27

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Syphilis

  1. STS:

Reactive – Go to question 28

Non-reactive – Go to question 28

Not done – Go to question 29

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Cytomegalovirus (CMV)

  1. Anti-CMV: (IgG or Total)

Reactive – Go to question 30

Non-reactive – Go to question 30

Not done – Go to question 31

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

West Nile Virus (WNV)

  1. WNV-NAT testing:

Positive – Go to question 32

Negative – Go to question 32

Not done – Go to question 33

Not applicable – Go to question 33

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Chagas

  1. Chagas testing

  • Positive – Go to question 34

  • Negative – Go to question 34

  • Not done – Go to question 35

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Herpes simplex virus (HSV)

  1. Anti-HSV (Herpes simplex virus antibody)

  • Positive – Go to question 36

  • Negative – Go to question 36

  • Not done – Go to question 37

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Epstein–Barr virus (EBV)

  1. Anti-EBV (Epstein–Barr virus antibody)

  • Positive – Go to question 38

  • Negative – Go to question 38

  • Inconclusive – Go to question 38

  • Not done – Go to question 39

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Varicella zoster virus (VZV)

  1. Anti-VZV (Varicella zoster virus antibody)

  • Positive – Go to question 40

  • Negative – Go to question 40

  • Not done – Go to question 41

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Toxoplasmosis

  1. Toxoplasmosis

  • Positive – Go to question 42

  • Negative – Go to question 42

  • Not done – Go to question 43

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Other Infectious Disease Marker

  1. Other infectious disease marker, specify:

Yes – Go to question 44

No – Go to signature line

  1. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify test and method:

  2. Specify test results:

Copy questions 44–46 to report multiple other infectious disease markers



First Name:

Last Name:

E-mail address:

Date: ___ ___ ___ ___ - ___ ___ - ___ ___

YYYY MM DD



CIBMTR Form 2004 IDM revision 4 (page 9 of 9) June 2009 FINAL FORM 12/11/2012<

Copyright © 2009 National Marrow Donor Program and

The Medical College of Wisconsin, Inc. All rights reserved.

Internal use: Document number F00479 revision 2 Replaces: F00479 version 1.0 July 2007

File Typeapplication/msword
File Title2004r2 Mockup
AuthorRobinette Aley
Last Modified Byemeissne
File Modified2013-02-07
File Created2012-11-14

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