Form ProdForm

Stem Cell Therapeutic Outcomes Database

Product_Form_2010

Stem Cell Therapeutic Outcomes Database (Prod Form)

OMB: 0915-0310

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OMB No: 0915-0310
Expiration Date: 10-31-2010
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 1.5
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.

OMB No: 0915-0310
Expiration Date: 10/31/2010

CIBMTR Center Number:
CIBMTR Recipient ID:

Hematopoietic Stem Cell
Transplant (HSCT) Infusion
Registry Use Only
Sequence
Number:

Specify donor:
1 o autologous
2 o NMDP unrelated
cord blood unit

3

NMDP Cord Blood Unit ID:

o NMDP unrelated
donor

NMDP Donor ID:
-

Date
Received:

o related donor
5 o non-NMDP
4

Donor’s / infant’s date of birth:

unrelated donor
6

o non-NMDP cord
blood unit
(include related and
autologous CBUs)

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 IDM Form
2004 and HLA Typing Form 2005, 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.

-

Month

Day

Year

Donor’s / infant’s gender:

1

o male

2

o female

Non-NMDP unrelated donor / cord blood unit ID:
(not applicable for related donor)

Is the CBU ID also the ICCBBA ISBT 128
number? 1 o yes 2 o no
Registry or UCB Bank ID:
Specify other Registry or UCB Bank:
Mother’s age
at donation:

Month

Day

Date of HSCT for which this form is
being completed: &
(check only one)

o autologous

Product type: o marrow
(check only one)

o age
unknown

2 0

Today’s Date:

HSCT type:

years

Year

2 0
Month

o allogeneic,
unrelated

Day

Year

o allogeneic, o syngeneic
related

(identical twin)

o PBSC o cord blood o other product,
specify:

This form must be completed for all recipients who receive a HSCT product. If more than one type of HSCT product
is infused, each product type must be analyzed and reported separately.
Questions followed by the symbol & indicate additional information necessary to complete the question is
referenced in the forms instruction manual; &A indicates an appendix.
A series of collections should be considered a single product when they are all from the same donor and use the
same collection method and technique (and mobilization, if applicable), even if the collections are performed on
different days.
CIBMTR Form 2006 revision 2 (page 1 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

Mail this form to your designated campus
(Milwaukee or Minneapolis). Retain the
original at the transplant center.

CIBMTR Center Number:

CIBMTR Recipient ID:

Pre-Collection Therapy
1. Did the donor receive treatment, prior to any stem cell harvest, to enhance the product collection for this HSCT?
(If the HSCT product was from an NMDP donor, or the product is a cord blood unit, then continue with question 20.)
1 o yes
Specify treatment(s): (select all that apply)
2 o no
2. 1 o yes 2 o no (autologous only)
3 o NMDP
Report details on disease-specific insert
Chemotherapy
donor
3. 1 o yes 2 o no (autologous only)
Report details on disease-specific insert
Anti-CD20 (rituximab, Rituxan)
Continue with
question 20
4

4.

1

o yes

2

o no Growth factor(s)

If yes, specify growth factor(s):
5.
6.
7.

o cord blood
unit

Continue with
question 20

9.

1

o yes

2

o no Other treatment

o yes
1 o yes
1 o yes
1

o no G-CSF
2 o no GM-CSF
2 o no Other
2

8. Specify:

10. Specify treatment:

Product Collection

2 0

11. Date of product collection:
Month

Day

Year

12. Was more than one collection required for this HSCT? &
1 o yes
13. Specify the number of subsequent days of collection in this episode:
2 o no
Complete a separate product form for each subsequent collection that was not part of this
mobilization.
14. Were anticoagulants added to the product during collection?
1 o yes
Specify anticoagulant(s):
2 o no
15. Acid citrate dextrose (ACD)
1 o yes
2 o no
16. Citrate phosphate dextrose (CPD)
1 o yes
2 o no
17. Heparin
1 o yes
2 o no
18. Other anticoagulant
1 o yes
2 o no

19. Specify other anticoagulant:

CIBMTR Form 2006 revision 2 (page 2 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

CIBMTR Center Number:

CIBMTR Recipient ID:

Product Transport and Receipt
20. Was this product collected off-site and shipped to your facility?
1 o yes
21. Date of receipt of product at your facility:
2 o no

2 0
Month

22. Time of receipt of product (24-hour clock):

Day

Year
1

:
Hour

Minute

2

o standard time
o daylight savings time

23. Specify the shipping environment of the product(s):
1 o frozen gel pack
2 o frozen cord blood unit(s)
3 o room temperature per transplant center request
4 o other
temperature
24. Specify shipping environment:
25. (Cord blood product only) Were the secondary containers (e.g., insulated shipping containers and
unit cassette) intact when they arrived at your center?
1 o yes
2 o no
26. (Cord blood product only) Was the cord blood unit completely frozen when it arrived at your
center?
1 o yes
2 o no
27. (Cord blood product only) Was the cord blood unit stored at your center prior to thawing?
1 o yes
28. Specify the storage method used for the cord blood unit:
2 o no
1 o liquid nitrogen
2 o vapor phase
3 o electric freezer
29. Temperature during storage: —

°C

2 0

30. Date storage started:
Month

Day

Year

Product Processing / Manipulation
31. Was a fresh product received, then cryopreserved at your facility prior to infusion?
1 o yes
2 o no
3 o not applicable, cord blood unit
32. Was the product thawed from a cryopreserved state prior to infusion?
1 o yes
33. Was the entire product thawed?
2 o no
1 o yes
2 o no
34. Was a compartment of the bag thawed?
1 o yes
2 o no
35. Were there multiple product bags?
1 o yes
36. Specify number of bags thawed:
2 o no
CIBMTR Form 2006 revision 2 (page 3 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

CIBMTR Center Number:

CIBMTR Recipient ID:

2 0

37. Date thawing process initiated:
Month

Day

Year
1

:

38. Time at initiation of thaw (24-hour clock):
Hour

39. Time at completion of thaw (24-hour clock):

Minute

1

:
Hour

2

Minute

2

o standard time
o daylight savings time
o standard time
o daylight savings time

40. Was the primary container (e.g., cord blood unit bag) intact upon thawing?
1 o yes
2 o no
41. What method was used to thaw the product?
1 o no wash — thawed at bedside, then infused
2 o DMSO dilution — thawed in lab (added dextran and albumin), then infused
3 o washed — thawed in lab (added dextran and albumin), spun and reconsituted in dextran
albumin, then infused
4 o other
42. Specify other thaw method:
method
43. Did any adverse events or incidents occur while thawing the product?
1 o yes
2 o no
44. Was the product manipulated prior to infusion?
1 o yes
45. Specify portion manipulated:
2 o no
1 o entire product
2 o portion of product
If autologous
product, continue
with question 92;
if allogeneic
product, continue
with question 141.

Specify all methods used to manipulate the product:
46. ABO incompatibility (RBC depletion)
1 o yes
Specify method:
2 o no
47. 1 o yes 2 o
48. 1 o yes 2 o
49. 1 o yes 2 o
50. 1 o yes 2 o
51. 1 o yes 2 o
52. 1 o yes 2 o

no
no
no
no
no
no

Buffy coat preparation
Cell separator (i.e., COBE Spectra)
Density gradient separation (i.e., Ficoll)
Plasma removal
Sedimentation (i.e., hetastarch)
Other
53. Specify other method:

54. Ex-vivo expansion
1 o yes
2 o no
55. Genetic manipulation (gene transfer / transduction)
1 o yes
2 o no
56. Volume reduction
1 o yes
2 o no
CIBMTR Form 2006 revision 2 (page 4 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

CIBMTR Center Number:

CIBMTR Recipient ID:

57. CD34+ selection &
1 o yes
58. Specify manufacturer:
2 o no
1 o CliniMACS / CliniMax
2 o Isolex
59. Specify other manufacturer:
3 o other
60. T-cell depletion
1 o yes
2 o no

71. Other cell
manipulation
1 o yes
2 o no

Specify method:
61. 1 o yes 2 o no Antibody affinity column
62. 1 o yes 2 o no Antibody coated plates
Report the
63. 1 o yes 2 o no Antibody coated plates
antibodies
and soybean lectin
used for T-cell
64 1 o yes 2 o no Antibody + complement
depletion at
question 73.
65. 1 o yes 2 o no Antibody + toxin
66. 1 o yes 2 o no Immunomagnetic beads
67. 1 o yes 2 o no Elutriation
68. 1 o yes 2 o no CD34 affinity column plus sheep red blood cell
rosetting &
70. Specify other method:
69. 1 o yes 2 o no Other

72. Specify other cell manipulation:

73. Were antibodies used during product manipulation?
1 o yes
Specify antibodies:
2 o no
74. 1 o yes 2 o no Anti CD2
75. 1 o yes 2 o no Anti CD3
76. 1 o yes 2 o no Anti CD4
77. 1 o yes 2 o no Anti CD5
78. 1 o yes 2 o no Anti CD6
79. 1 o yes 2 o no Anti CD7
80. 1 o yes 2 o no Anti CD8
81. 1 o yes 2 o no Anti CD34
82. 1 o yes 2 o no Anti TCR alpha / beta (T10-B9)
83. 1 o yes 2 o no OKT-3
84. 1 o yes 2 o no Other CD3
85. Specify other CD3:

86.

1

o yes

2

o no Anti CD52

Specify antibodies:
yes

87.
88.
89.
90.

1

o yes

2

Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

no

o Campath-NOS
2 o Campath-1G
2 o Campath-1H
2

o no Other
antibody

CIBMTR Form 2006 revision 2 (page 5 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

o
1o
1o
1

91. Specify other antibody:

CIBMTR Center Number:

CIBMTR Recipient ID:

Autologous Products Only
The following section refers to autologous products only, including autologous cord blood; if this is not an autologous
HSCT, continue with the Product Analysis section at question 141.
92. Were tumor cells detected in the recipient or autologous product prior to HSCT?
1 o yes
Specify tumor cell detection method used, and site(s) of tumor cells:
2 o no
93. Routine
histopathology
Specify site(s):
1 o yes
94. 1 o yes 2 o no 3 o not tested Circulating blood cells
2 o no
95. 1 o yes 2 o no 3 o not tested Bone marrow, in the interval
between last systemic therapy
and collection
97. Polymerase
96. 1 o yes 2 o no 3 o not tested Collected cells, before purging
chain reaction
(PCR)
Specify site(s):
1 o yes
98. 1 o yes 2 o no 3 o not tested Circulating blood cells
2 o no
99. 1 o yes 2 o no 3 o not tested Bone marrow, in the interval
between last systemic therapy
and collection
100.
1
o
yes
2
o
no
3
o
not
tested
Collected
cells, before purging
101. Other molecular
technique
1 o yes
102. Specify method:
2 o no
Specify site(s):
103. 1 o yes
104. 1 o yes

106. Immunohistochemistry
1 o yes
2 o no

110. Cell culture
technique
1 o yes
2 o no

3

o not tested Circulating blood cells
o not tested Bone marrow, in the interval

o no

3

between last systemic therapy
and collection
o not tested Collected cells, before purging

Specify site(s):
107. 1 o yes 2 o no
108. 1 o yes 2 o no

3

105. 1 o yes

2

o no
o no

3

o not tested Circulating blood cells
o not tested Bone marrow, in the interval

o no

3

between last systemic therapy
and collection
o not tested Collected cells, before purging

Specify site(s):
111. 1 o yes 2 o no
112. 1 o yes 2 o no

3

109. 1 o yes

1

o yes

2

2

o no

3

o not tested Circulating blood cells
o not tested Bone marrow, in the interval

3

between last systemic therapy
and collection
o not tested Collected cells, before purging

115. Specify method:
Specify site(s):
116.
117.

CIBMTR Form 2006 revision 2 (page 6 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

2

3

113.
114. Other technique
1 o yes
2 o no

2

118.

1
1

1

o yes
o yes
o yes

Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

2
2

2

o no
o no
o no

3

o not tested Circulating blood cells
o not tested Bone marrow, in the interval

3

between last systemic therapy
and collection
o not tested Collected cells, before purging

3

CIBMTR Center Number:

CIBMTR Recipient ID:

119. Was the product treated to remove malignant cells (purged)? (autologous product only)
1 o yes
Specify method(s) used:
2 o no
121. If yes, specify:
120. 1 o yes 2 o no Monoclonal antibody
122. 1
123. 1
124. 1
126. 1
127 1
128. 1

o yes
o yes
o yes
o yes
o yes
o yes

130. 1 o yes

o no
2 o no
2 o no
2 o no
2 o no
2 o no
2

2

4-hydroperoxycyclophosphamide (4HC)
Mafosfamide
125. If yes, specify:
Other drug
Elutriation
Immunomagnetic column
129. If yes, specify:
Toxin

o no Positive stem cell selection
(other than preparation
of mononuclear
fraction)

132. 1 o yes

2

o no Other method

131. If yes, specify method:
133. If yes, specify:

Specify if tumor cells were detected in the graft after purging by each method used:
134. 1 o yes 2 o no 3 o not tested Routine histopathology
135. 1 o yes 2 o no 3 o not tested Polymerase chain reaction (PCR)
136. 1 o yes 2 o no 3 o not tested Other molecular technique
137. 1 o yes 2 o no 3 o not tested Immunohistochemistry
138. 1 o yes 2 o no 3 o not tested Cell culture technique
139. 1 o yes 2 o no 3 o not tested Other
140. If yes, specify:

Product Analysis (All Products) &
Product Analysis at 1st Timepoint
Specify the timepoint in 141.
the product preparation
phase that the product
was analyzed:

1
2

3
4
5

o product arrival
o post-processing,

162.

2 0
Month

Day

3
4
5

1
2

o mL
og

CIBMTR Form 2006 revision 2 (page 7 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

o product arrival
o post-processing,
pre-cryopreservation /
manipulation &
o post-thaw
o post-manipulation
o at infusion (final quantity infused)

2 0

163.

Year

•

1
2

pre-cryopreservation /
manipulation &
o post-thaw
o post-manipulation
o at infusion (final quantity infused)

Date of product analysis: 142.

Total volume of product: 143.

Product Analysis at 2nd Timepoint

Month

164.

Day

Year
1

•

2

o mL
og

CIBMTR Center Number:

CIBMTR Recipient ID:

Product Analysis at 1st Timepoint

Product Analysis at 2nd Timepoint

In this section, report the total number of cells (not cells per kilogram).
Total Number
Nucleated cells:

144.

Mononucleated cells:

145.

•
•

Nucleated red blood cells: 146.
CD34+ cells:

147.

CD3+ cells:

148.

CD4+ cells:

149.

CD8+ cells:

150.

Viability of cells:

151.

Method of testing cell
viability:

152.

•
•
•
•
•
o
o
3o
4o
2

o not tested 165.

x 10

o not tested 166.

x 10

o not tested 167.

x 10

o not tested 168.

x 10

o not tested 169.

x 10

o not tested 170.

x 10

o not tested 171.

7-AAD
propidium iodide
trypan blue
other method

Exponent

•
•
•
•
•
•
•

172.
173.

o
o
3o
4o
1

x 10

o not tested

x 10

o not tested

x 10

o not tested

x 10

o not tested

x 10

o not tested

x 10

o not tested

x 10

o not tested

o not tested

%

2

Specify other method: 153.
Were the colony-forming 154.
units (CFU) assessed
after thawing?
(cord blood product only)

Total Number

x 10

o not tested

%
1

Exponent

7-AAD
propidium iodide
trypan blue
other method

174.

o yes
2 o no

Continue with question 155

1

o yes

175.

Continue with question 158

o no

Continue with question 176

o yes

Continue with question 179

o no

Was there growth?

155.

Total colonies per
product:

156.

•

x 105

o unknown

177.

•

x 105

o unknown

Total CFU-GM:

157.

•

x 105

o unknown

178.

•

x 105

o unknown

Were cultures performed 158.
before infusion to test the
product(s) for bacterial or
fungal infection?
(complete for all cell products)
Specify results:

159.

1

2

o yes
2 o no
1

1

o positive

176.

o yes
2 o no
1

Continue with question 159

179.

Continue with question 162

2

o negative

3

o unknown

180.

Specify organism
160.
code(s):
(see page 9 for codes)

181.

If code 198, 209,
219, or 259, specify
organism:

182.

161.

CIBMTR Form 2006 revision 2 (page 8 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

1

2

o yes
2 o no
1

1

o positive

Continue with question 180
Continue with question 183

2

o negative

3

o unknown

CIBMTR Center Number:

CIBMTR Recipient ID:

Codes for Commonly Reported Organisms
Bacterial Infections
121 Acinetobacter
122 Actinomyces
123 Bacillus
124 Bacteroides (gracillis,
uniformis, vulgaris, other
species)
125 Bordetella pertussis
(whooping cough)
126 Borrelia (Lyme disease)
127 Branhamella or Moraxella
catarrhalis (other species)
128 Campylobacter (all species)
129 Capnocytophaga
171 Chlamydia pneumoniae
172 Other chlamydia, specify
113 Chlamydia, NOS
130 Citrobacter (freundii, other
species)
131 Clostridium (all species
except difficile)
132 Clostridium difficile
173 Corynebacterium jeikeium
133 Corynebacterium (all nondiptheria species)
101 Coxiella
134 Enterobacter
177 Enterococcus, vancomycin
resistant (VRE)
135 Enterococcus (all species)
136 Escherichia (also E. coli)
137 Flavimonas oryzihabitans
138 Flavobacterium

139 Fusobacterium
144 Haemophilus (all species,
including influenzae)
145 Helicobacter pylori
146 Klebsiella
147 Lactobacillus (bulgaricus,
acidophilus, other species)
102 Legionella
103 Leptospira
148 Leptotrichia buccalis
149 Leuconostoc (all species)
104 Listeria
150 Methylobacterium
151 Micrococcus, NOS
112 Mycobacterium avium–
intracellulare (MAC, MAI)
174 Mycobacterium species
(cheloneae, fortuitum,
haemophilum, kansasii,
mucogenicum
110 Mycobacterium tuberculosis
(tuberculosis, Koch bacillus)
175 Other mycobacterium,
specify
176 Mycobacterium, NOS
105 Mycoplasma
152 Neisseria (gonorrhoea,
meningitidis, other species)
106 Nocardia
153 Pasteurella multocida
154 Propionibacterium (acnes,
avidum, granulosum, other
species)

155 Proteus
156 Pseudomonas (all species
except cepacia &
maltophilia)
157 Pseudomonas or
Burkholderia cepacia
158 Pseudomonas or
Stenotrophomonas or
Xanthomonas maltophilia
159 Rhodococcus
107 Rickettsia
160 Salmonella (all species)
161 Serratia marcescens
162 Shigella
163 Staphylococcus, coagulase
negative (not aureus)
164 Staphylococcus aureus
165 Staphylococcus, NOS
166 Stomatococcus
mucilaginosis
167 Streptococcus (all species
except Enterococcus)
178 Streptococcus pneumoniae
168 Treponema (syphilis)
169 Vibrio (all species)
197 Multiple bacteria at a single
site, specify bacterial codes
198 Other bacteria, specify ‡
501 Suspected atypical bacterial
infection
502 Suspected bacterial
infection

Fungal Infections
200 Candida, NOS
201 Candida albicans
206 Candida guillermondi
202 Candida krusei
207 Candida lusitaniae
203 Candida parapsilosis
204 Candida tropicalis
205 Candida (Torulopsis)
glabrata
209 Other Candida, specify ‡
210 Aspergillus, NOS
211 Aspergillus flavus
212 Aspergillus fumigatus
213 Aspergillus niger
219 Other Aspergillus, specify ‡
220 Cryptococcus species
230 Fusarium species
261 Histoplasmosis
240 Zygomycetes, NOS
241 Mucormycosis
242 Rhizopus
250 Yeast, NOS
259 Other fungus, specify ‡
260 Pneumocystis (PCP / PJP)
503 Suspected fungal infection

‡ The codes for “other organism, specify” (codes 198, 209, 219 and 259) should rarely be needed; check with your microbiology lab
or HSCT physician before using them.

Product Infusion
183. Was more than one product infused? (e.g., marrow and PBSC, PBSC and cord blood, two different cords, etc.)
1 o yes
184. Was the product infusion described on this insert intended to produce hematopoietic
2 o no
engraftment?
1 o yes
185. Date of this product infusion:
2 o no

2 0

Month

1

:

186. Time product infusion initiated (24-hour clock):
Hour

Minute

1

:

187. Time product infusion completed (24-hour clock):
Hour

2

Minute

CIBMTR Form 2006 revision 2 (page 9 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

2

Day

o standard time
o daylight savings time
o standard time
o daylight savings time

Year

CIBMTR Center Number:

CIBMTR Recipient ID:

188. Total volume of product plus additives infused:

•

mL

189. Specify the route of product infusion:
1 o intravenous
2 o intramedullary
3 o intraperitoneal
4 o other route of
190. Specify route of infusion:
infusion
191. Did the volume of infused product include any added agents?
1 o yes
Specify agent(s) added:
2 o no
192. 1 o yes 2 o no ACD
193. 1 o yes 2 o no Albumin
194. 1 o yes 2 o no Antibiotic
195. 1 o yes 2 o no Dextran
196. 1 o yes 2 o no Heparin
197. 1 o yes 2 o no Other

198. Specify agent:

199. Was the entire volume of product infused?
1 o yes
200. Specify what happened to the reserved portion:
2 o no
1 o discarded
2 o cryopreserved for future use
3 o other fate
201. Specify:

The following questions refer to all stem cell products except for autologous marrow or autologous PBSC products.
If this HSCT used an autologous marrow or autologous PBSC product, continue with the signature lines at question 296.
202. Were there any adverse events or incidents associated with the stem cell infusion?
1 o yes
Specify the following adverse event(s):
2 o no

Required Medical
Intervention?

Adverse Event

203. 1
206. 1
209. 1
212. 1

o yes
o yes
o yes
o yes

215. 1 o yes
218. 1
221. 1
224. 1
227. 1
230. 1
233. 1

o yes
o yes
o yes
o yes
o yes
o yes

236. 1 o yes
239. 1 o yes
242. 1 o yes

o no
o no
2 o no
2 o no
2
2

2

o no

o no
2 o no
2 o no
2 o no
2 o no
2 o no
2

Brachycardia
Chest tightness / pain
Chills at time of infusion
Fever ≤ 103° F within 24
hours of infusion
Fever > 103° F within 24
hours of infusion
Gross hemoglobinuria
Headache
Hives
Hypertension
Hypotension
Hypoxia requiring oxygen
(O2) support

o no Nausea
o no Rigors, mild
2 o no Rigors, severe
2
2

CIBMTR Form 2006 revision 2 (page 10 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

o yes
o yes
1 o yes

o no
o no
2 o no

205.
208.
211.

1

2

1

2

o no

214.

1

o no
o no
2 o no
2 o no
2 o no
2 o no

217.
220.
223.
226.
229.
232.

1

2

1

2

o no
2 o no
2 o no
2 o no

235.

204.
207.
210.

1

2

1

2

213.

1

216.
219.
222.
225.
228.
231.

1

2

1

2

o yes

o yes
o yes
1 o yes
1 o yes
1 o yes
1 o yes

o yes
237. 1 o yes
240. 1 o yes
243. 1 o yes
234.

1

Resolved?

2

2

o yes
o yes
1 o yes
o yes

o yes
o yes
1 o yes
1 o yes
1 o yes
1 o yes

o yes
238. 1 o yes
241. 1 o yes
244. 1 o yes
1

o no
o no
2 o no
2

o no

o no
o no
2 o no
2 o no
2 o no
2 o no
o no
2 o no
2 o no
2 o no
2

CIBMTR Center Number:

CIBMTR Recipient ID:

Required Medical
Intervention?

Adverse Event

245. 1
248. 1
251. 1
254. 1

o yes
o yes
o yes
o yes

258. 1 o yes

o no
2 o no
2 o no
2 o no
2

2

Shortness of breath (SOB) 246.
Tachycardia
249.
Vomiting
252.
Other expected AE
255. Specify:
256.
o no Other unexpected AE
259. Specify:
260.

o yes
1 o yes
1 o yes
1

Resolved?

o no
2 o no
2 o no

247.
250.
253.

1

2

o yes
1 o yes
1 o yes

o no
2 o no
2 o no
2

1

o yes

2

o no

257.

1

o yes

2

o no

1

o yes

2

o no

261.

1

o yes

2

o no

262. In the Medical Director's judgement, was the adverse event a direct result of the infusion?
1 o yes
263. Specify the most likely cause of the adverse event:
2 o no
1 o regimen related
2 o product reaction
3 o drug reaction
4 o other illness
264. Specify illness:
5

o other reason

265. Specify reason:

Donor / Infant Demographic Information
This Donor Demographic Information section (questions 266–281) is to be completed for all non-NMDP allogeneic donors.
If the stem cell product was from an NMDP donor or an autologous marrow or PBSC donor, continue with the signature
lines at question 296.
266. (Female donor only) Was the donor ever pregnant?
1 o yes
267. Specify number of pregnancies:
2 o no
3 o unknown
4 o not applicable /
cord blood unit
268. Donor’s blood type and Rh factor:
1 o A positive
2 o A negative
3 o B positive
4 o B negative
5 o AB positive
6 o AB negative
7 o O positive
8 o O negative
9 o unknown

CIBMTR Form 2006 revision 2 (page 11 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

o unknown

CIBMTR Center Number:

CIBMTR Recipient ID:

269. Did this donor have a central line placed?
1 o yes
270. Specify the site of the central line placement:
2 o no
1 o femoral
3 o not applicable,
2 o subclavian
cord blood unit
3 o internal jugular
or marrow product
271 Specify site:
4 o other site
272. Donor’s ethnicity:
1 o Hispanic or Latino
2 o not Hispanic nor Latino
3 o unknown
273. Donor’s race: (Mark the group(s) in which the donor is a member. Check all that apply.) &A
White
1 o Eastern European
2 o Mediterranean
3 o Middle Eastern
4 o North Coast of Africa
5 o North American
6 o Northern European
7 o Western European
8 o White Caribbean
9 o White South or
Central American
10 o Other White

Black or African American
11 o African (both parents
born in Africa)
12 o African American
13 o Black Caribbean
14 o Black South or
Central American
American Indian or
Alaska Native
15 o Alaskan Native or Aleut
16 o North American Indian

17

o American Indian, South

18

or Central America
o Caribbean Indian

Asian
19 o South Asian
20 o Filipino (Pilipino)
21 o Japanese
22 o Korean
23 o Chinese
24 o Vietnamese
25 o Other Southeast Asian

274. What is the relationship of the donor to the recipient?
1 o sibling
2 o recipient’s child
3 o other relative
275. Specify the relationship of the donor to the recipient:
4 o unrelated
1 o parent

o aunt
o uncle
4 o cousin
5 o other
2
3

relative

276. Specify relationship:

277. Was the donor / product tested for potentially transplantable genetic diseases?
1 o yes
Specify disease(s) tested:
2 o no
278. 1 o yes 2 o no Sickle cell anemia
3 o unknown
279. 1 o yes 2 o no Thalassemia
280. 1 o yes 2 o no Other
281. Specify genetic disease:

CIBMTR Form 2006 revision 2 (page 12 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

Native Hawaiian or Other
Pacific Islander
26 o Guamanian
27 o Hawaiian
28 o Samoan
29 o Other Pacific Islander
Decline
o Donor declines to
provide race
31 o Donor’s race unknown
30

CIBMTR Center Number:

CIBMTR Recipient ID:

The following questions 282–295 apply only to allogeneic non-NMDP donors. If the stem cell product was from an
autologous donor or NMDP donor, or was a cord blood unit, then continue with the signature lines at question 296.
282. Was the donor hospitalized (inpatient) during or after the collection?
1 o yes
2 o no
283. Did the donor experience any life-threatening complications during or after the collection?
1 o yes
284. Specify complications:
2 o no
285. Did the donor receive blood transfusions as a result of the collection?
1 o yes
286. Was the blood transfusion product autologous?
2 o no
1 o yes
287. Specify number of units:
2 o no
288. Was the blood transfusion product allogeneic (homologous)?
1 o yes
289. Specify number of units:
2 o no
290. Did the donor die as a result of the collection?
1 o yes
291. Specify cause of death:
2 o no
292. (Related donors only) Did the recipient submit a research sample?
1 o yes
293. Research sample recipient ID:
2 o no
294. (Related donors only) Did the donor submit a research sample?
1 o yes
295. Research sample donor ID:
2 o no

296. Signed:
Person completing form

Please print name:
Phone number: (
Fax number: (

)
)

E-mail address:

CIBMTR Form 2006 revision 2 (page 13 of 13) June 2009
Copyright © 2009 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007

OMB No: 0915-0310
Expiration Date: 10/31/2010

CIBMTR Center Number:
CIBMTR Recipient ID:

Confirmation of HLA Typing
Registry Use Only

Specify non-NMDP donor:
1

o related donor

2

o non-NMDP
unrelated donor

3

Sequence
Number:

o non-NMDP cord
blood unit
(include related and
autologous CBUs)

Date
Received:

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 IDM Form 2004 and HSCT 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.

Donor’s / infant’s date of birth:

Month

Non-NMDP unrelated donor / cord blood unit ID:
(not applicable for related donor)

2 0
Month

Day

Year

Date of HSCT for which this form is
being completed: &
(check only one)

Year

Donor’s / infant’s gender:
1 o male
2 o female

Today’s Date:

HSCT type:

Day

o allogeneic,

o allogeneic,

unrelated

Product type: o marrow

2 0
Month

related

Day

Year

o syngeneic
(identical twin)

o PBSC o cord blood o other product,

(check only one)

specify:

This form must be completed for all non-NMDP allogeneic or syngeneic donors or recipients, or non-NMDP cord
blood units. If the donor, recipient, or cord blood unit was secured through the NMDP, then report HLA typing on
the appropriate NMDP forms.
A separate copy of this form should be completed for each non-NMDP donor, recipient, or cord blood unit.
1. Specify the person for whom this typing is being done:
1 o recipient — final typing
2 o recipient’s mother —
confirmatory typing
2. Was the recipient’s mother used as the donor?
1 o yes
2 o no
3

o recipient’s father —

4

o donor — confirmatory

5

o cord blood unit —

confirmatory typing
typing

3. Was the recipient’s father used as the donor?
1 o yes
2 o no

confirmatory typing

o maternal HLA typing
7 o other
6

4. Specify person and typing:

CIBMTR Form 2005 revision 3 (page 1 of 5) April 2010
Copyright © 2010 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00480 revision 3 Replaces: F00480 revision 2 June 2009

Mail this form to your designated campus
(Milwaukee or Minneapolis). Retain the
original at the transplant center.

CIBMTR Center Number:

CIBMTR Recipient ID:

HLA Typing by DNA Technology
Space is provided for reporting several possible alleles for each allele at a locus. If more space is needed, write the remainder of the
alleles in the space above or below the box for that locus. A lab report may be attached to the completed report to provide additional
information or typing result clarification for the form review process at the NMDP.
5. Is a copy of the laboratory report attached?
1 o yes
2 o no

Class I
Locus

6.

A

Allele Designations

o not
tested

First A*

Second
A*
7.

B

o not

tested

First B*
Second
B*

8.

C

o not

tested

First C*
Second
C*

Class II
Locus

9. DRB1 o not
tested

Allele Designations

First
DRB1*
Second
DRB1*

CIBMTR Form 2005 revision 3 (page 2 of 5) April 2010
Copyright © 2010 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00480 revision 3 Replaces: F00480 revision 2 June 2009

CIBMTR Center Number:

CIBMTR Recipient ID:

Class II (Optional)
Please provide the optional allele information if it is available from your laboratory.
Locus

10. DRB3 o not
tested

Allele Designations

First
DRB3*
Second
DRB3*

11. DRB4 o not
tested

First
DRB4*
Second
DRB4*

12. DRB5 o not
tested

First
DRB5*
Second
DRB5*

13. DQB1 o not
tested

First
DQB1*
Second
DQB1*

14. DPB1 o not
tested

First
DPB1*
Second
DPB1*

15. DQA1 o not
tested

First
DQA1*
Second
DQA1*

16. DPA1 o not
tested

First
DPA1*
Second
DPA1*

CIBMTR Form 2005 revision 3 (page 3 of 5) April 2010
Copyright © 2010 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00480 revision 3 Replaces: F00480 revision 2 June 2009

CIBMTR Center Number:

CIBMTR Recipient ID:

Antigens Defined by Serologic Typing
Use the following lists when reporting HLA-A and B antigens. Report broad antigens only when your laboratory was not able to
confirm typing for a known split antigen.
A Antigens

B Antigens

17. No. of antigens provided:
1 o one
2 o two

18. Number of antigens provided:
1 o one
2 o two

Specificity

A1
A2
A203
A210
A3
A9
A10
A11
A19
A23(9)
A24(9)
A2403
A25(10)
A26(10)
A28
A29(19)
A30(19)
A31(19)
A32(19)
A33(19)
A34(10)
A36
A43
A66(10)
A68(28)
A69(28)
A74(19)
A80
AX

Antigen
1st
2nd

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
99

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

Specificity

Antigen
1st
2nd

Specificity

Antigen
1st
2nd

B5
B7
B703
B8
B12
B13
B14
B15
B16
B17
B18
B21
B22
B27
B2708
B35
B37
B38(16)
B39(16)
B3901
B3902

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

B40
B4005
B41
B42
B44(12)
B45(12)
B46
B47
B48
B49(21)
B50(21)
B51(5)
B5102
B5103
B52(5)
B53
B54(22)
B55(22)
B56(22)
B57(17)
B58(17)

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

01
02
03
04
05
06
07
08
09
10
11
12
13
14
59
15
16
17
18
19
20

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

CIBMTR Form 2005 revision 3 (page 4 of 5) April 2010
Copyright © 2010 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00480 revision 3 Replaces: F00480 revision 2 June 2009

21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

Specificity

Antigen
1st
2nd

B59
B60(40)
B61(40)
B62(15)
B63(15)
B64(14)
B65(14)
B67
B70
B71(70)
B72(70)
B73
B75(15)
B76(15)
B77(15)
B78
B81
B82
BX

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
60
99

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

CIBMTR Center Number:

CIBMTR Recipient ID:

Optional Antigen Reporting
Please provide the following optional antigen information if it is available from your laboratory.

Antigens Defined by Serologic Typing
C Antigens

DR Antigens

19. No. of antigens provided:
1 o one
2 o two
Antigen
1st
2nd

Specificity

o
o
o
o
o
o
o
o
o
o
o

Cw1
Cw2
Cw3
Cw4
Cw5
Cw6
Cw7
Cw8
Cw9(w3)
Cw10(w3)
CX

Bw Specificity
Specificity

20. Bw4
21. Bw6

Present?
2o

o yes
1 o yes
1

2

22. No. of antigens provided:
1 o one
2 o two
Specificity

o
o
o
o
o
o
o
o
o
o
o

01
02
03
04
05
06
07
08
09
10
99

no

o no

DR51 Antigen

DR1
DR103
DR2
DR3
DR4
DR5
DR6
DR7
DR8
DR9
DR10
DR11(5)
DR12(5)
DR13(6)
DR14(6)
DR1403
DR1404
DR15(2)
DR16(2)
DR17(3)
DR18(3)
DRX

Antigen
1st
2nd

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
81
99

o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o

Specificity

23. DR51

Specificity

24. DR52

Fax: (

)
)

E-mail address:

CIBMTR Form 2005 revision 3 (page 5 of 5) April 2010
Copyright © 2010 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.
Internal use: Document number F00480 revision 3 Replaces: F00480 revision 2 June 2009

1

27. No. of antigens provided:
1 o one
2 o two

Present?
2

o yes

Specificity

o no

DR53 Antigen
Specificity

25. DR53

1

Present?
2

o yes

o no

DQ Antigens
26. No. of antigens provided:
1 o one
2 o two
Specificity

DQ1
DQ2
DQ3
DQ4
DQ5(1)
DQ6(1)
DQ7(3)
DQ8(3)
DQ9(3)
DQX

Person completing form

Phone: (

o no

DR52 Antigen

28. Signed:
Please print name:

DP Antigens

Present?
1 o yes 2

Antigen
1st
2nd

o
o
o
o
o
o
o
o
o
o

01
02
03
04
05
06
07
08
09
99

o
o
o
o
o
o
o
o
o
o

DPw1
DPw2
DPw3
DPw4
DPw5
DPw6
DPX

Antigen
1st
2nd

o
o
o
o
o
o
o

01
02
03
04
05
06
99

o
o
o
o
o
o
o

OMB No: 0915-0310
Expiration Date: 10/31/2010

CIBMTR Center Number:
CIBMTR Recipient ID:

Infectious Disease Markers
Registry Use Only
Sequence
Number:

Specify non-NMDP donor:
1

o related donor

2

o non-NMDP
unrelated donor

3

o non-NMDP cord
blood unit
(include related and
autologous CBUs)

Date
Received:

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 HSCT 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.

Donor’s / infant’s date of birth:

Month

Day

Donor’s / infant’s gender:
1 o male
2 o female
Non-NMDP unrelated donor / cord blood unit ID:
(not applicable for related donor)

2 0

Today’s Date:
Month

Day

Year

Date of HSCT for which this form is
being completed: &
HSCT type:
(check only one)

Year

o allogeneic,
unrelated

Product type: o marrow

2 0
Month

o allogeneic,

Day

Year

o syngeneic

related

(identical twin)

o PBSC o cord blood o other product,

(check only one)

specify:

This form must be completed for all non-NMDP allogeneic or syngeneic donors, or non-NMDP cord blood units.
If the donor or cord blood unit was secured through the NMDP, then report IDMs on forms 24 and 50 for allogeneic
donors or through CORD Link for cord blood units.
1. Who is being tested for IDMs?
1 o donor IDM (marrow or PBSC)
2 o maternal IDM (cord blood)
3 o cord blood unit IDM

Infectious Disease Marker (report final test results)
Hepatitis B Virus (HBV)
2. HBsAg: (hepatitis B surface antigen)
1 o reactive
2 o non-reactive
3 o testing not performed
4. Anti HBc: (hepatitis B core antibody) (no confirmatory test available)
1 o reactive
2 o non-reactive
3 o testing not performed
Hepatitis C Virus (HCV)
6. Anti-HCV: (hepatitis C antibody)
1 o reactive
2 o non-reactive
3 o testing not performed
CIBMTR Form 2004 revision 2 (page 1 of 3) June 2009
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

Test Date
Month

Day

Year

3.

2 0

5.

2 0

7.

2 0

Mail this form to your designated campus
(Milwaukee or Minneapolis). Retain the
original at the transplant center.

CIBMTR Center Number:

CIBMTR Recipient ID:

Infectious Disease Marker (report final test results)

Test Date
Month

Human T-Lymphotropic Virus
8. Anti-HTLV I / II:
1 o reactive
2 o non-reactive
3 o testing not performed

Day

Year

9.

2 0

11.

2 0

14.

2 0

16.

2 0

18.

2 0

Human Immunodeficiency Virus (HIV)
10. HIV-1 p24 antigen:
1 o reactive
2 o non-reactive
3 o not reported
4 o not performed; HIV NAT testing performed (skip date)
12. Was FDA licensed NAT testing for HIV-1 / HCV performed?
1 o yes
Specify results:
2 o no
13. HIV-1

o positive
2 o negative
3 o not reported
1

15. HCV
1 o positive
2 o negative
17. 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.

o reactive
o non-reactive
3 o testing not performed
4 o not reported
1
2

Syphilis
19. STS:
1 o reactive
2 o non-reactive
3 o testing not performed

20.

2 0

22.

2 0

Cytomegalovirus (CMV)
21. Anti-CMV: (IgG or Total)
1 o reactive
2 o non-reactive
3 o testing not performed

CIBMTR Form 2004 revision 2 (page 2 of 3) June 2009
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

CIBMTR Center Number:

CIBMTR Recipient ID:

Infectious Disease Marker (report final test results)

Test Date
Month

West Nile Virus (WNV)
23. WNV-NAT testing:
1 o positive
2 o negative
3 o testing not performed
4 o not applicable

24.

25. Other infectious disease marker, specify (e.g., EBV):
1 o yes
26. Specify date performed:
2 o no

Day

Year

2 0

2 0

27. Specify test and method:
28. Specify test results:
29. Other infectious disease marker, specify (e.g., EBV):
1 o yes
30. Specify date performed:
2 o no

2 0

31. Specify test and method:
32. Specify test results:
33. Other infectious disease marker, specify (e.g., EBV):
1 o yes
34. Specify date performed:
2 o no
35. Specify test and method:
36. Specify test results:

37. Signed:
Person completing form

Please print name:
Phone number: (
Fax number: (

)
)

E-mail address:

CIBMTR Form 2004 revision 2 (page 3 of 3) June 2009
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

2 0


File Typeapplication/pdf
File Titlecombine-2004 IDMs r2_0120 v11.0.qxd
Authorchansen
File Modified2010-09-03
File Created2009-06-15

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