. "Appendix C: Survey Results." Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press, 2005.
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
C
SURVEY RESULTS
TABLE C-1 Banks That Responded
Bank
State
American Red Cross North Central Blood Services Cord Blood Program
MN
Carolinas Cord Blood Bank
NC
Children’s Hospital of Orange County Cord Blood Bank
CA
Cord Blood Registry
CA
Cryobanks International, Inc.
FL
ITxM Cord Blood Services
IL
JP McCarthy Cord Stem Cell Bank
MI
Lifebank USA
NJ
LifeCord
FL
LifeStor
VA
Michigan Community Blood Centers Cord Blood Bank
MI
National Cord Blood Program of the New York Blood Center
NY
New Jersey Cord Blood Bank
NJ
Puget Sound Blood Center and Hawaii Cord Blood Bank
WA
Sibling Donor Cord Blood Program Children’s Hospital Oakland Research Institute
CA
South Texas Blood & Tissue Center
TX
St. Louis Cord Blood Bank
MO
StemCyte International Cord Blood Center and Cord Blood Family Trust
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
C
SURVEY RESULTS
TABLE C-1 Banks That Responded
Bank
State
American Red Cross North Central Blood Services Cord Blood Program
MN
Carolinas Cord Blood Bank
NC
Children’s Hospital of Orange County Cord Blood Bank
CA
Cord Blood Registry
CA
Cryobanks International, Inc.
FL
ITxM Cord Blood Services
IL
JP McCarthy Cord Stem Cell Bank
MI
Lifebank USA
NJ
LifeCord
FL
LifeStor
VA
Michigan Community Blood Centers Cord Blood Bank
MI
National Cord Blood Program of the New York Blood Center
NY
New Jersey Cord Blood Bank
NJ
Puget Sound Blood Center and Hawaii Cord Blood Bank
WA
Sibling Donor Cord Blood Program Children’s Hospital Oakland Research Institute
CA
South Texas Blood & Tissue Center
TX
St. Louis Cord Blood Bank
MO
StemCyte International Cord Blood Center and Cord Blood Family Trust
CA
The Elie Katz Umbilical Cord Blood Program
NJ
University of Colorado Cord Blood Bank
CO
Viacord
MA
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-2 Type of Bank
PUBLIC BANKS
American Red Cross North Central Blood Services Cord Blood Program
JP McCarthy Cord Stem Cell Bank
Michigan Community Blood Centers Cord Blood Bank
National Cord Blood Program of the New York Blood Center
New Jersey Cord Blood Bank
South Texas Blood & Tissue Center
St. Louis Cord Blood Bank
University of Colorado Cord Blood Bank
PRIVATE BANKS
Cord Blood Registry
LifeStor
Sibling Donor Cord Blood Program Children’s Hospital Oakland Research Institute
Viacord
BANKS THAT OFFER BOTH
Carolinas Cord Blood Bank
Children’s Hospital of Orange County Cord Blood Bank
Cryobanks International, Inc.
ITxM Cord Blood Services
Lifebank USA
LifeCord
Puget Sound Blood Center and Hawaii Cord Blood Bank
StemCyte Inc. and Cord Blood Family Trust
The Elie Katz Umbilical Cord Blood Program at Community Blood Services
Totals: 8 Public, 4 Private, 9 Mixed
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-3 Self-Reported Accreditationa
Bank
FACT
AABB
Otherb
American Red Cross North Central Blood Services Cord Blood Program
X
Carolinas Cord Blood Bank
X
FACT pending, NMDP
Children’s Hospital of Orange County Cord Blood Bank
X
JCAHO, California Tissue Bank License, Seeking FACT Accreditation
Cord Blood Registry
X
Cryobanks International, Inc.
X
ITxM Cord Blood Services
Will apply for FACT this fall
JP McCarthy Cord Stem Cell Bank
NMDP
Lifebank USA
X
ISO
LifeCord
X
X
NMDP
Michigan Community Blood Centers Cord Blood Bank
X
FDA Registration
National Cord Blood Program of the New York Blood Center
X
New York State Board of Health
New Jersey Cord Blood Bank
Puget Sound Blood Center and Hawaii Cord Blood Bank
X
Sibling Donor Cord Blood Program Children’s Hospital
Oakland Research Institute
X
California State Biologies, California State Tissue Bank (both current)
St. Louis Cord Blood Bank
X
CAP
StemCyte, Inc. and Cord Blood Family Trust
X
ASHI, NMDP, CAP, California Biologics License, CLIA, FACT pending
The Elie Katz Umbilical Cord Blood Program
X
University of Colorado Cord Blood Bank
X
Viacord
X
CLIA, CAP proficiency, NY State, NJ State, KY State, PA State, registered with FDA and IL State, and MD tissue bank permit
aThe accreditation status of the banks was not independently verified.
bThe definitions of the acronyms are provided at the end of this appendix.
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-4 Numbers of Collected, Stored, and Transplanted Units
Bank
Consenting to Collect
Collected
Banked
Available
Searchable
Used for Transplant
Note
American Red Cross North Central Blood Services Cord Blood Program
23,130
18,680
6,069
5,962
5,962
242
8 not transplanted
Carolinas Cord Blood Bank
17,519
17,000
8,300
7,800
7,800
320
Children’s Hospital of Orange County Cord Blood Bank
3390
2,900
1,550
1,375
1,350
7
Cryobanks International, Inc.
17,741
15,429
9,439
7,485
7,485
5
4 public, 1 private
ITxM Cord Blood Services
9,867
5,280
5,000
2,620
2,513
20
Consenting refers to collection kits requested
JP McCarthy Cord Stem Cell Bank
3323
2,486
600
517
445
4
Lifebank USA
17,807
17,228
16,264
3,300
3,300
1
LifeCord
1
7,429
1,975
1,474
1,474
10
LifeStor
102
96
Michigan Community Blood Centers Cord Blood Bank
6,665
5,531
1,497
1,386
1,375
6
National Cord Blood Program of the New York Blood Center
27,328
29,525
25,989
25,989
25,989
1,765
Includes first and second transplantations and multiple-unit grafts
New Jersey Cord Blood Bank
2,621
1,984
1,796
1,796
7
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
Bank Name
Consenting to Collect
Collected
Banked
Available
Searchable
Used for Transplant
Note
Puget Sound Blood Center and Hawaii Cord Blood Bank
3,877
2,358
1,097
727
727
5
Sibling Program Children’s Hospital Oakland Research Institute
1,556
1,438
1,378
1,064
0
43
St. Louis Cord Blood Bank
40,000
40,000
10,000
10,000
10,000
656
10,000 means >10,000. Searches include NMDP, CRIR, and direct searches. Transplants are through June 30, 2004
StemCyte, Inc. and Cord Blood Family Trust
16,777
13,566
8,558
8,331
8,331
78
The Elie Katz Umbilical Cord Blood Program
3,635
2,473
2,473
1,511
25
University of Colorado Cord Blood Bank
10,000
9,943
7,017
6,669
6,435
234
Total consenting not known with precision
Viacord
60,000
60,000
0
14
60,000 means >60,000. Every consent resulted in a collection.
Total
259,083
255,145
109,190
62,979
60,504
3,384
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
FIGURE C-1 Total units collected, by bank.
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-5 Banks That Are Currently Collecting Units
Bank
American Red Cross North Central Blood Services Cord Blood Program
Carolinas Cord Blood Bank
Children’s Hospital of Orange County Cord Blood Bank
Cord Blood Registry
Cryobanks International, Inc.
ITxM Cord Blood Services
JP McCarthy Cord Stem Cell Bank
Lifebank USA/Anthrogenesis Corp.
LifeCord
Michigan Community Blood Centers Cord Blood Bank
National Cord Blood Program of the New York Blood Center
New Jersey Cord Blood Bank
Puget Sound Blood Center and Hawaii Cord Blood Bank
Sibling Program Children’s Hospital Oakland Research Institute
St. Louis Cord Blood Bank
StemCyte, Inc. and Cord Blood Family Trust
The Elie Katz Umbilical Cord Blood Program
Viacord
FIGURE C-2 Available units—across all banks.
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-6 Racial Makeup of Inventory
Percent Available
Asian
African American
Hispanic
Native American
Middle Eastern
Caucasian
Unknown
Multiracial
Other
Averages by total number of units
5.79
11.60
16.81
1.02
0.11
56.08
4.89
3.01
0.69
BY BANK
American Red Cross North Central Blood Services Cord Blood Program
2.47
6.59
12.03
0.37
64.64
13.90
Carolinas Cord Blood Bank
2.21
19.52
9.26
0.14
0.00
59.15
0.02
9.21
0.50
Children’s Hospital of Orange Country Cord Blood Bank
17.70
0.67
35.40
2.67
43.55
0.00
0.00
0.00
Cryobanks International, Inc.
1.92
8.06
11.16
1.12
0.57
67.24
0.28
9.65
ITxM Cord Blood Services
3.72
2.16
5.58
1.38
0.00
86.46
0.43
0.26
JP McCarthy Cord Stem Cell Bank
0.45
80.67
2.25
0.22
6.52
9.66
0.22
LifeCord
0.83
3.32
2.76
0.00
0.41
82.72
9.95
Michigan Community Blood Centers Cord Blood Bank
1.17
2.20
3.03
1.38
64.19
28.03
National Cord Blood Program of the New York Blood Center
7.70
21.00
21.10
45.60
4.60
New Jersey Cord Blood Bank
2.17
7.24
0.50
0.89
0.39
61.41
27.39
Puget Sound Blood Center and Hawaii Cord Blood Bank
33.01
1.79
4.54
4.26
56.40
St. Louis Cord Blood Bank
0.66
1.59
0.28
4.69
84.35
0.94
7.50
StemCyte, Inc. and Cord Blood Family Trust
14.99
4.00
51.01
0.39
27.00
2.62
The Elie Katz Umbilical Cord Blood Program
2.02
2.95
10.96
0.08
1.05
42.74
40.19
0.00
0.00
Averages by bank
6.50
11.55
12.13
1.35
0.41
56.57
10.06
5.80
4.73
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-7 Criteria to Determine Which Units Are Suitable for Banking
Bank
Threshold of Nucleated Cell Dose
Volume
Bacterial Contamination (Negative)
American Red Cross North Central Blood Services Cord Blood Program
Preprocessing TNC of 1.2 × 109
50 ml
X
Carolinas Cord Blood Bank
9 × 108
60 ml
X
Children’s Hospital of Orange County Cord Blood Bank
9 × 108
40 ml minimum
X
Cryobanks International, Inc.
Precount >8 × 108
60 g
X
ITxM Cord Blood Services
40 ml collection per NMDP IND
X
JP McCarthy Cord Stem Cell Bank
X
Lifebank USA
TNC = 5 × 108
35 ml
X
LifeCord
8 × 108 TNC preprocessing
≥40 ml
Michigan Community Blood Centers Cord Blood Bank
11 × 108, minority threshold = 9.5 × 108
45 ml
X
National Cord Blood Program of the New York Blood Center
9 × 108
X
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
Level of HLA Resolution
Other
Donation is excluded if:
unit is reactive for infectious disease markers
unit has less than 70 percent postprocessing and prefreezing viability
there is a family history of diseases, conditions, and/or genetic disorders that may affect the recipient
the mother has symptoms of or has been diagnosed with certain infectious diseases including West Nile virus, parasitic blood diseases, syphilis, hepatitis, and HIV/AIDs
the mother has engaged in behaviors or received medical treatments that increase the risk of contracting these diseases
Intermediate resolution for Class I HLA, highresolution DRB1
Tests negative for homozygous hemoglobinopathies; positive CFU growth
Negative infectious disease testing on maternal blood
Negative maternal infectious disease markers, processed within 36 hours of collection
Maternal and baby health questionnaire eligibility Infectious disease testing, microbiology testing, hemaglobinopathy screen, viability
Infectious disease markers, ABO and RH type determination of cord blood unit, newborn screening retention samples, maternal medical health questionnaire, review of maternal and newborn medical records
Virology negative (except for CMV)
Negative infectious disease test results, lack of family medical history of inherited genetic disorders or diseases, no inappropriate affirmative responses to questions from risk behavior questionnaire
Negative infectious disease testing, normal genetic screen “We also apply the same deferral criteria as that of whole blood donors for risk factors”
Class I antigen level (molecular test, SSP)
No evidence of viral infection for HIV/HILV-1/11, hepatitis B or C virus, CMV by culture or DNA PCR testing.
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
Bank
Threshold of Nucleated Cell Dose
Volume
Bacterial Contamination (Negative)
New Jersey Cord Blood Bank
minimum of 1.5 × 108 preprocessing, 1.2 × 108 postprocessing
>40 ml of cord blood
X
Puget Sound Blood Center and Hawaii Cord Blood Bank
9 × 108
40 ml
Sibling Program Children’s ≤ Hospital Oakland Research Institute
3 × 108
≤20 cc
St. Louis Cord Blood Bank
>8.0 × 108
45 ml
X
StemCyte, Inc. and Cord Blood Family Trust
50 ml public, 10 ml private
X
The Elie Katz Umbilical Cord Blood Program
4 × 108 TNC for autologous storage and 6 × 108 TNC for allogeneic
if less than 50 ml then check TNC
X
University of Colorado Cord Blood Bank
TNC greater than 109*
≥95 ml collected*
X
Viacord
100 × 106 TNC
≥10 ml
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
Public
Reimbursement
$18,000
Pending $18,500
$15,500
$15,000 per NMDP
$15,500
$25,000
$22,490—includes patient CT-negative unit CT-positive Unit DNA for transplant center CT, unit shipment in the United States
NMDP provides $15,500 for a unit when it is transplanted.
$15,000
$15,000 before 2004, $21,500 after 1/1/04
$0
$17,000
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-17 Funding of Public Banks
Bank
When
NIH
Private/Philanthropy
State Funding
American Red Cross North Central Blood Services Cord Blood Program
Currently
Historically
X
Carolinas Cord Blood Bank
Currently
Historically
X
X
Children’s Hospital of Orange County Cord Blood Bank
Currently
X
Historically
X
ITxM Cord Blood Services
Currently
X
Historically
X
LifeCord
Currently
Historically
Michigan Community Blood Centers Cord Blood Bank
Currently
X
Historically
X
National Cord Blood Program of the New York Blood Center
Currently
X
Historically
X
X
New Jersey Cord Blood Bank
Currently
X
Historically
X
X
Puget Sound Blood Center and Hawaii Cord Blood Bank
Currently
X
Historically
X
Sibling Program Children’s Hospital Oakland Research Institute
Currently
X
X
Historically
X
X
St. Louis Cord Blood Bank
Currently
X
Historically
X
StemCyte, Inc and Cord Blood Family Trust
Currently
X
Historically
X
The Elie Katz Umbilical Cord Blood Program
Currently
Historically
University of Colorado Cord Blood Bank
Currently
Historically
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
Public Bank
Revenue
Other
X
X
Support From ARC
X
ARC
By participating entities, UF, Shands, LifeSouth
By participating entities, UF, Shands, LifeSouth
X
X
X
NYBC
X
NYBC
X
X
X
X
X
Fund raising
X
Fund raising
Private bank revenue
Private bank revenue
Self-supporting from reimbursement fees
University of Colorado Hospital
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-18 Neonatal Health Status Follow-Up
Bank
If There Is Follow-Up in Neonatal Health Status, When Is It Done?
American Red Cross North Central Blood Services Cord Blood Bank
Delivery data are assessed 24 hours or more after delivery. In addition, donors are reminded in a follow-up letter/survey mailed 60 days after delivery and in a birthday card sent at 1 year, to ask the family to report on any changes in infant’s health.
Carolinas Cord Blood Bank
Yes, 24-hour review of pediatric exam/neonatal history 6 months or more, computer system; mom’s age > 35 years and no amniocentesis follow-up unit at time of request
Children’s Hospital of Orange County Cord Blood Bank
None
Cryobanks International, Inc.
No follow-up of neonatal health status is done at present
ITxM Cord Blood Services
Yes, before release for transplantation; not always able to locate the mother
JP McCarthy Cord Stem Cell Bank
No follow-up after the baby has been discharged from the hospital
Lifebank USA
No
LifeCord
No. However, the mother is asked to call if a health problem arises; the bank receives notification of leukemia in an infant whose cord blood was donated.
Michigan Community Blood Centers Cord Blood Bank
(1) No formal follow-up. (2) Donor moms are given a card to keep in baby’s book asking for notification if child becomes seriously ill.
National Cord Blood Program of the New York Blood Center
No
New Jersey Cord Blood Bank
Follow-up from the donor is requested at 6 months and 1 year
Puget Sound Blood Center and Hawaii Cord Blood Bank
Yes, prior to transplant (when a cord blood unit has been selected for use)
Sibling Program Children’s Hospital Oakland Research Institute
Hemoglobinopathy screening is performed on the cord blood unit. Clinical status of donor is reviewed before release of the unit for transplantation
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How Is Follow-Up Performed?
Postcard Phone Call to Mother Other
X
X
Review of medical record from pediatrician office
X
X
X
X
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
Bank
If There Is Follow-Up in Neonatal Health Status, When Is It done?
St. Louis Cord Blood Bank
Yes, 2 weeks postdelivery and when confirmatory typing is requested on a cord blood unit
StemCyte, Inc. and Cord Blood Family Trust
The mother is asked to notify the bank of any change in the health status of the child. A letter with a SASE requesting a response regarding the health of the child is sent between 6 months and 1 year postdelivery.
The Elie Katz Umbilical Cord Blood Program
No for public units; yes for private units
University of Colorado Cord Blood Bank
No
Viacord
Not proactive, at customer request
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
How Is Follow-Up Performed?
Postcard Phone Call to Mother Other
X
X
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
TABLE C-19 How the Units Are Stored
Stored as
Bank
Whole Blood
Volume Reduction Only
RRC Depleted/Mononuclear Cell Product
American Red Cross North Central Blood Services Cord Blood Bank
X
Carolinas Cord Blood Bank
X
Children’s Hospital of Orange County Cord Blood Bank
X
Cryobanks International, Inc.
X
ITxM Cord Blood Services
X
X
JP McCarthy Cord Stem Cell Bank
X
Lifebank USA
X
LifeCord
X (<50 processed this way)
X
Michigan Community Blood Centers Cord Blood Bank
X
National Cord Blood Program of the New York Blood Center
X
New Jersey Cord Blood Bank
X
Puget Sound Blood Center and Hawaii Cord Blood Bank
X
Sibling Program Children’s Hospital Oakland Research Institute
X
St. Louis Cord Blood Bank
StemCyte, Inc. and Cord Blood Family Trust
The Elie Katz Umbilical Cord Blood Program
University of Colorado Cord Blood Bank
X
Viacell
X
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
Other
Anticoagulant Used
Cryoprotectant Used
CPD
DMSO/dextran
X
X
X
X
CPD solution
Stemsol-DMSO, 99% purity,
USP
USP grade
X
CPD
DMSO-dextran
X
X
X
CPD-Adenine
DMSO 10%, HES 1%, dextran40 1%
X
X
ACD-A
DMSO
CPD
DMSO-dextran 40, (unit nos. 668 to present) DSMO-pentastarch-plasma (unit nos 1 to 667)
Buffy coat (RBC and plasma reduced)
CPD
DMSO
Plasma depleted, non-redcell-depleted product
CPD solution
DMSO-Gentran
Red cell depleted with volume reduction
CPD
10% DMSO
CPD
DMSO
CPD
DMSO
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
ACRONYMS AND ABBREVIATIONS
AABB
American Association of Blood Banks
ACD-A
Anticoagulant Citrate Dextrose Solution, formula A
ARC
American Red Cross
ASHI
American Society for Histocompatibility and Immunogenetics
BMDW
Bone Marrow Donors Worldwide
BMT
bone marrow transplant
CAH
congenital adrenal hyperplasia
CAP
College of American Pathologists
CBB
cord blood bank
CLIA
Clinical Laboratory Improvement Amendments
CMV
cytomegalovirus
CPD
citrate-phosphate-dextrose
CRIR
Caitlin Raymond International Registry
DMSO
dimethyl sulfoxide
EBMT
European Group for Blood and Marrow Transplantation
FACT
Foundation for the Accreditation of Cellular Therapy
FDA
Food and Drug Administration
g
gram(s)
HbcAb
hepatitis B core antibody
HBV
hepatitis B virus
HCV
hepatitis C virus
HELLP
haemolysis, elevated liver enzymes, low platelets
HES
hetastarch
HIV
human immunodeficiency virus
HLA
human leukocyte antigen
IgG
immunoglobulin G
IND
investigational new drug
IRB
institutional review board
ISBT
International Society of Blood Transfusion
ISCT
International Society for Cellular Therapy
ISO
International Organization for Standardization
JACIE
Joint Accreditation Committee ISCT EBMT
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JCAHO
Joint Commission for Accreditation of Healthcare Organizations
MCAD
medium-chain acyl-CoA dehydrogenase
ml
milliliter(s)
NAT
nucleic acid test
NIH
National Institutes of Health
NMDP
National Marrow Donor Program
NYBC
New York Blood Center
PCR
polymerase chain reaction
PKU
phenylketonuria
RBC
red blood cell
SARS
sudden acute respiratory syndrome
SASE
self-addressed stamped envelope
SQL
structured query language
SSP
split spectrum processing
TNC
total nucleated cell count
UCLA
University of California, Los Angeles
UF
University of Florida
USP
United States Pharmacopeia
vCJF
variant Creutzfeldt-Jakob disease
WMDA
World Marrow Donor Association
WNV
West Nile virus
