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pdfForm Approved
OMB No. 0990-0313
Exp. Date XXXXXXXX
m
2011 National Blood
Collection and Utilization Survey
Your help is critical to assess the adequacy of our blood resources.
This biennial survey is the single best means of determining detailed accurate information
about collection and utilization of blood and blood components in the United States. The
data you contribute and the time you take to ensure its accuracy are critical to the
success of the survey and the interpretation of findings. In the past, we have asked
questions about blood, blood components, and cell therapy collection and utilization.
This year, due to the needs of the blood banking and hospital blood resource providers,
there are questions regarding detailed utilization, biovigilance, human tissue collection
and utilization, and the practices related to these products and services. We look forward
to seeing what unfolds and to sharing that report with you. Thank you in advance for your
participation in this important national survey.
If you have any questions regarding the survey, while you are compiling the data or
afterwards, please call our toll-free number: ____________.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it
displays a valid OMB control number. The valid OMB control number for this information collection is 0990-0313. The time
required to complete this information collection is estimated to average 1 hour per response, including the time to review
instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you
have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S.
Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 531-H, Washington D.C. 20201,
Attention: HHS PRA Reports Clearance Officer OMB No. 0990-0313.
Statement on Data Release
The completed questionnaires will be processed and data compiled for analysis and used for statistical purposes only. No
institutional data provided in response to this survey will be reported that may allow a blood center or hospital to be identified.
Results will be released only in aggregate form. Public use data from this survey may be used by researchers throughout the
blood community. The public use data sets will be in a format that will adhere to HIPAA standards and will minimize the risk of
identification of the responding institution.
2011 National Blood
Collection and Utilization Survey
Instructions: Please read carefully!
• Report all data for the 2010 calendar year, 1/1/10 through 12/31/10, unless otherwise
specified (some questions are about current practices only). If your institution cannot
provide calendar year data, please report data for the most recent 12-month period
that your institution has available.
• Answer all questions—DO NOT LEAVE ANY ITEMS BLANK, unless instructed to skip
an item.
• If your answer is zero, it is important that you enter “0” rather than leaving a blank.
• Be sure your responses are printed clearly and legibly.
• Consult your records whenever possible to provide the most accurate information
available. If records are not available, please provide your best estimate, or that of
your most qualified co-worker. It may be necessary for you to forward this questionnaire to another department for completion of some items.
• Before you begin, read the glossary on the inside back cover of this booklet. Terms
included in the glossary are underlined when first used in the survey.
• If you have any questions, please call the toll-free survey helpline at xxx-xxx-xxxx or
send an e-mail to ___________________.
• Be sure to make and keep a copy of your completed questionnaire before returning it.
• Thank you in advance for your assistance with this important survey!
1
Section A. General Information
A1.
Prefix
A2.
A3.
Provide the name, title, telephone number, and e-mail address of each person
completing this survey:
First Name
Last Name
Title/Position
Telephone
E-mail
Is your institution [Choose one]:
1
A local or regional blood center (non-hospital) that collects blood from
donors and supplies blood and components to other facilities?
2
A hospital-based blood bank and transfusion service that collects blood from
donors (may be only autologous or directed) and provides blood and
components for transfusion primarily to your own facility?
3
A transfusion service that provides blood and components for transfusion,
but does not collect blood from donors?
4
A local or regional blood center that collects blood from donors and supplies
blood, components, and crossmatched blood products to participating
facilities (such as a centralized transfusion service)? In this category, the
service is not limited to reference laboratory work, but includes routine
transfusion service work.
Does your institution collect, process, manufacture, store, distribute, and/or transplant
hematopoietic progenitor cells (HPCs) or other cell therapy products? [If you perform
only infectious disease testing, please check “No.”]
Yes
No
2
A4.
Does your institution maintain an inventory of, or use human tissue for
transplantation? [If you perform only infectious disease testing, please check “No”.]
Yes
No
A5.
List the official name, city, state, and zip code of every institution for which data are
reported on this questionnaire. [If necessary, continue on the opposite page.]
a. Institution Name
Street Address
City
State
Zip
City
State
Zip
City
State
Zip
b. Institution Name
Street Address
c. Institution Name
Street Address
3
A6.
Does your institution serve as a transfusion service for other institutions?
Yes
No
Which other institutions are served? [Please provide the official name, city, and state of
every such facility, if different from your institution. Attach a separate sheet if needed.]
a. Institution Name
Street Address
City
State
Zip
City
State
Zip
City
State
Zip
b. Institution Name
Street Address
c. Institution Name
Street Address
PLEASE GO TO SECTION B
4
Section B. Blood Collection, Processing, and Testing
This section includes questions about blood donors, blood collection and testing. All facilities
should answer question B1. Any facility collecting blood should complete the rest of the section.
B1.
B2.
Does your institution collect blood from donors? [If you collect autologous units only,
check “Yes” and complete this section.]
Yes
COMPLETE THIS SECTION
No
SKIP TO SECTION C
How many collection procedures (and for automated collections, how many products?)
were successfully completed by your institution in each of the following categories in
2010? [If a breakdown is not available, put the total under “Allogeneic Whole Blood.”
Do not count low-volume or incomplete procedures.]
Manual Whole Blood Collections
No. of Procedures
1)
Community (non-directed allogeneic donations)
2)
Autologous
3)
Directed
No. of
Procedures
Automated Collections (Continued)
1)
2)
Apheresis red cells [Count double units resulting
from double collections as two units.]
a.
Allogeneic red cells
b.
Autologous red cells
c.
Directed red cells
d.
Concurrent plasma
e.
Concurrent plasma – jumbo
Apheresis platelets
a.
Single-donor platelets
b.
Directed single-donor platelets
c.
Concurrent plasma
d.
Concurrent plasma – jumbo
e.
Concurrent red cells
5
No. of
Products
No. of
Procedures
Automated Collections (Continued)
3)
B3.
No. of
Products
Plasmapheresis
a.
Jumbo FFP (>400 mL)
b.
FFP/24-hour plasma (FP24)
How many units were collected by your institution at mobile blood drive sites:
units
B4.
How many units were processed by your institution in each of the following categories
in 2010?
a. Number of whole blood units processed for
distribution as whole blood:
units
b. Number of red cell units processed:
[Count double units resulting from double collections
as two units. Exclude pediatric units. Include packed
red cells plus units from red cell apheresis.]
units
B5.
How many whole blood and red cells units (combined) were released for initial
distribution? [Count double units resulting from double collections as two units. Units
returned and released for distribution multiple times should be counted only once.]
TOTAL
B6.
How many units of the following were produced from whole blood?
a.
FFP
units
b.
Plasma frozen within 24 hours
units
c.
Plasma cryoprecipitate reduced
units
6
B7.
B8.
B9.
B10.
Of the following components, how many units were produced by your institution in
2010? [Count double or triple units resulting from double or triple collections or splits as
two or three units. Count pools of whole-blood-derived platelets or cryoprecipitate in
terms of individual unit equivalents.]
a.
Plasma for further manufacture
units
b.
Whole-blood-derived platelets
units
c.
Apheresis platelets from single collections
[do not include autologous or therapeutic units]
units
d.
Apheresis platelets produced from double collections
units
e.
Apheresis platelets produced from triple collections
units
f.
Cryoprecipitate
units
g.
Granulocytes
units
For each of the following categories, how many units did your institution collect/
prepare/modify to achieve prestorage leukoreduction in 2010?
a.
Red cells/whole blood
units
b.
Whole-blood-derived platelets
units
c.
Apheresis platelets
units
d.
Other component units, including pediatric units
units
From how many of the following types of donors did you successfully collect blood
products in 2010?
a.
First-time allogeneic donors
donors
b.
Repeat allogeneic donors
donors
c.
Directed donors
donors
In 2010, how many people presented to donate?
people
7
B11.
B12.
How many people were deferred for the following reasons:
Low hemoglobin
people
Other medical reasons
people
High-risk behavior
people
Travel
people
How many donations were from repeat allogeneic donors?
donations
B13.
How many units were collected from 16- to 24-year-old donors?
units
B14.
How many units were collected from all minority populations (ie, including African,
Asian, and/or Hispanic origin, combined)
units
B15.
How many severe donor adverse events did you have in 2010?
From whole blood collections:
events
From automated collections:
events
B16.
Do you perform HLA testing for TRALI prevention purposes?
Yes
No
B17.
Do you perform HNA testing for TRALI prevention purposes?
Yes
No
B18.
What was the total number of allogeneic units (non-directed and directed combined)
discarded in 2010 for abnormal disease marker test results?
units
B19.
What was the total number of allogeneic units (non-directed and directed combined)
discarded in 2010 for all other reasons?
units
8
B20.
For all tested donations collected by your facility in 2010, indicate the number of
repeat reactive and confirmed positive allogeneic donors by infectious disease marker
below:
No. of Repeat
Reactive
Allogeneic
Donors
Infectious Disease Marker
a.
Anti-HIV-1/HIV-2
b.
Anti-HTLV-I/II
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.
Anti-HCV
Anti-HBc
HBsAg
Serologic test for syphilis
HIV-1 NAT (antibody negative)
HCV NAT (antibody negative)
Undifferentiated NAT (if HIV-1 and
HCV discriminatory negative when
applicable)
WNV NAT
Anti-Trypanosoma cruzi (Chagas
disease)
HBV NAT
PLEASE GO TO SECTION C
9
No. of
Confirmed
Positive
Allogeneic
Donors
Test Not
Performed
Section C. Blood Transfusion
This section should be completed by transfusion services and includes questions about
transfusion, utilization, availability, and hemovigilance. All facilities should complete question
C1. Any facility transfusing blood or serving as a centralized transfusion service for others should
complete this section.
C1.
C2.
Is your institution directly involved in the transfusion of blood to patients or does it
serve as a transfusion service for another institution that transfuses blood?
Yes
COMPLETE THIS SECTION
No
SKIP TO SECTION D
In 2010, how many units of allogeneic whole blood and red cells (WB/RBCs) did your
institution transfuse either directly or as a transfusion service for another institution?
[Exclude directed units transfused to the intended patients.]
Total No. of
Units Transfused
Total No. of
Recipients
Allogeneic Whole Blood
Allogeneic Red Blood Cells
C3.
Indicate below the total number of units transfused in each of the following categories
and report the number of recipients of these units.
Total No. of
Units Transfused
Total No. of
Recipients
a. Directed WB/RBC units transfused
to the intended patient
b. Autologous WB/RBC units
transfused to the autologous donor
C4.
Indicate below the total number of units transfused to the pediatric population (as
defined by your institution).
No. of Adult Equivalent Units
Used in Whole or in Part for
Pediatric Patients
a. WB/RBCs
b. Plasma
c. Platelets
10
No. of Pediatric
Recipients
C5.
In 2010, how many units of each of the following components did your institution
transfuse, either directly or as a transfusion service for another institution?
a.
Whole-blood-derived platelets
[Individual concentrates and pools expressed as
individual concentrate equivalents]
units
b.
Apheresis platelet units – full dose (≥3 × 1011)
units
c.
Directed platelets to intended recipients
units
d.
FFP
units
e.
Pediatric size (100 mL) FFP
units
f.
Plasma, frozen within 24 hours
units
g.
Jumbo plasma (>400 mL)
units
h.
Plasma cryoprecipitate reduced
units
i.
Cryoprecipitate (all uses)
[Include individual units and pools expressed as unit
equivalents]
units
Granulocyte units
units
j.
C6.
Indicate below how many irradiated, leukoreduced, and leukofiltered units of each of
the following components your institution transfused, either directly or as a transfusion
service for another institution in 2010 (for pediatrics use the number of adult
equivalent units used in whole or part). Components that are both irradiated and
leukoreduced should be included in the count for both columns.
Components
Irradiated
a.
WB/RBCs
b.
Whole-blood-derived
platelets
Apheresis platelets
c.
d.
Other blood component
units, including pediatric
units
11
Components
Leukoreduced Before
or After Storage
(Not at the Bedside)
Components
Leukofiltered
at the Bedside
C7.
How many units of blood in your facility went to the following departments in 2010?
[this can be determined by location or by physician use.]
Department
a. Surgery – general
b. Orthopedic surgery
c. Cardiac surgery
d. Trauma/ER
e. Hematology/Oncology
f. Transplantation services
g. Obstetrics/Gynecology
h.
i.
j.
k.
l.
C8.
No. of RBC Units
Pediatrics/Neonatology
Nephrology/Dialysis
ICU
General medicine
Other
What is the average age of a unit transfused at your institution?
Component
C9.
No. of Platelet Units
Days
Calculated
Average
Estimate
Don’t
Know
a.
Red Blood Cells
b.
Whole-blood-derived
platelets
c.
5-Day apheresis platelets…
d.
7-Day apheresis platelets…
In 2010, how many therapeutic platelet doses were transfused?
a.
As plateletpheresis products
doses
b.
As whole-blood-derived platelets
doses
If you indicated a quantity above, what is the usual (most
common) dosage at your institution of whole blood units from
which the dose was derived? [Check one.]
<3
3
4
5
6
12
7
8
9
10
>10
C10.
What volume of plasma is most commonly transfused during a single transfusion
episode at your institution?
mL
C10a.
Do you routinely transfuse plasma (to non-pediatric patients) based on: (Choose one)
Patient size
Unit volume
C11.
How many grams of IVIG (not RhIG) were purchased by your institution?
grams
C12.
What was the average whole dollar amount your institution paid per unit in 2010 for
the following components? [Include discounts in your calculations. A response of $0
should be entered as “NA” rather than 0.]
Average
Amount Paid
C13.
a. Plasma, frozen within 8 hours of phlebotomy
$
a. Plasma, frozen within 24 hours of phlebotomy
$
b. Red cells, leukofiltered
$
c. Whole-blood-derived platelets, not leukoreduced, not irradiated
$
d. Apheresis platelets, leukoreduced
$
e. Cryoprecipitate
$
Does your institution have an established “bloodless” surgery program?
Yes
No
Don’t know
C14.
Does your hospital use intraoperative autologous blood recovery therapies?
Yes
No
Don’t know
13
C15.
How many days in 2010 was elective surgery postponed due to actual blood inventory
shortages?
days
If any, how many surgeries were postponed?
[Do not count any single patient’s surgery more
than once.]
surgeries
C16.
C17.
On how many days in 2010 was your order incomplete?
a.
For red cells
days
b.
For plasma
days
c.
For apheresis platelets
days
d.
For whole-blood-derived platelets
days
On how many days in 2010 were you unable to meet other non-surgical blood requests
(eg, red cells, platelets)?
days
C18.
At your facility, how many units of group O red cells are on your shelf on an average
weekday?
units
C19.
At your facility, what is the maximum number of units of group O positive and group O
negative red cells in uncrossmatched inventory considered to be “critically low”?
units
C20.
How many WB/RBC crossmatch procedures were performed at your facility in 2010 by
any method?
procedures
C21.
How many samples (patient specimens submitted for testing) did your facility receive
at the blood bank in 2010?
samples
14
C22.
Does your facility currently collect data on sample collection errors (eg, wrong blood
in tube)?
Yes
No
If yes, How many were reported in 2010?
C23.
errors
How many transfusion-related adverse reactions were reported to the transfusion
service in 2010? [Count the number of reactions that required any diagnostic or
therapeutic intervention.]
reactions
If any reactions reported, complete the table below indicating how types of each
reaction occured:
Event Description
a.
Life-threatening, requiring major medical intervention following the
transfusion, eg, vasopressors, blood pressure support, intubation, or
transfer to the intensive care unit?
b.
Transfusion-related acute lung injury (TRALI)?
c.
ABO incompatibility?
d.
Transfusion-associated circulatory overload (TACO)?
e.
Acute hemolysis?
f.
Delayed hemolysis?
g.
Posttransfusion sepsis
h.
Severe allergic reactions?
PLEASE GO TO SECTION D
15
No. of Reactions
Section D. Bacterial Testing
This section pertains to methods used for testing for bacteria in platelets. Question D1 should be
completed by all facilities.
D1.
D2.
Does your institution perform bacterial testing?
Yes
COMPLETE THIS SECTION
No
SKIP TO SECTION E
Indicate what methods are used by your institution to limit/detect bacterial
contamination? [Check the applicable boxes.]
CultureBased
Testing
a.
Apheresis platelets?
b.
Whole-blood-derived
platelets, singly?
Whole-blood-derived
platelets, pooled?
c.
D3.
Swirling
pH
Glucose
Other
None
How many confirmed positives and false positives were detected by method in 2010?
Method
a.
Culture-based methods
b.
Rapid immunoassay
c.
Alternative methods
No. Tested
No. of Confirmed
Positives
PLEASE GO TO SECTION E
16
No. of False
Positives
Section E. Product Disposition
This section contains questions about products disposition performed by both collection and
treatment facilities and should be completed by all facilities.
E1.
E2.
E3.
In 2010, how many autologous and directed units of red cells and whole blood were
crossed over to the community supply?
a.
Autologous
units
b.
Directed
units
How many total units of red cells, group O positive red cells, and group O negative red
cells (allogeneic, non-directed) were outdated in 2010? [Include only those units that
were outdated while on your shelf. If you transfuse blood, include units outdated at your
institution, as well as any other institutions for which you serve as a transfusion service.]
a.
All Red Cell Units outdated
units
b.
Group O positive red cells outdated
units
c.
Group O negative red cells outdated
units
How many units in each of the following categories were outdated in 2010? [Include
only those units that were outdated while on your shelf. If you transfuse blood, include
units outdated at your institution, as well as any other institutions for which you serve as
a transfusion service.]
a.
Whole blood
units
b.
FFP or FP24 (including whole-blood-derived and apheresis
plasma)
units
c.
Whole-blood-derived platelets (express pools as individual
unit equivalents)
units
d.
Apheresis platelets
units
e.
Cryoprecipitate (express pools as individual unit
equivalents)
units
f.
Directed WB/RBC units
units
g.
Autologous WB/RBC units
units
PLEASE GO TO SECTION F
17
Section F. Human Tissue
This section contains questions regarding the use of human tissue for transplantation. Please give
this section to the appropriate laboratory or other specialized personnel to complete!
F1.
Does your institution maintain an inventory of, or use, human tissue for
transplantation? Refer to the definition of tissue in the Glossary – this differs from the
definition of “tissue” used by The Joint Commission in their Standards)
Yes
No
F2.
F3.
SKIP TO END
In 2010, what was the total number of human tissue implants/grafts that your facility:
[Include acellular dermal matrix products (eg, alloderm, repleform, etc) and consult with
specialty departments, if necessary (eg, Orthopedics/ Dermatology/ Ophthalmology).]
a.
Used/implanted?
implants/grafts
b.
Discarded?
implants/grafts
c.
Returned?
implants/grafts
d.
Removed/explanted?
implants/grafts
Do you maintain an inventory of human skin? Product used for burn application,
traumatic wound, and integument problems.
Yes
No
F4.
In 2010 how many proven tissue-related adverse events have you reported from human
tissue implants/grafts?
events
F5.
If available: [Please direct to the appropriate department eg, risk management, quality
assurance, etc.]
a.
b.
c.
d.
How many reported adverse events were related to
viral transmission?
events
How many reported adverse events were related to
bacterial infection?
events
How many reported adverse events were related to
fungal infection?
events
How many adverse events were related to graft failure?
events
18
Section G: Cellular Therapy Products
Please give this section to the appropriate cellular therapy collection or laboratory personnel to
complete!
GT1.
Choose which of the following best describes your program. Is your program a:
Blood center performing HPC collections only
Blood center collecting, processing, and/or storing HPCs
HPC collection facility within hospital
HPC collection, processing, and storage facility within hospital
Cord blood collection facility only
Other, please describe _________________________
OR
Cord blood processing/storage facility only (SKIP TO QUESTION GT4)
HPC processing/storage facility within hospital (SKIP TO QUESTION GT4)
GT2.
Do you collect products for third party vendors (including cord blood banks, NMDP,
and other suppliers of CT products)?
Yes
No
If yes, how many did you collect in 2010? [Check appropriate boxes
below.]
HPC-A
Hematopoietic
Progenitor
Cells –
Apheresis
<10 per year
11-100 per year
101-500 per year
>500 per year
19
HPC-M
Hematopoietic
Progenitor Cells –
Marrow
HPC-C
Hematopoietic
Progenitor
Cells – Cord
Other
GT3.
Are any CT products at your facility used for cardiology applications?
Yes
No
Don’t know
GT4.
Does your program collect cord blood?
Yes
No
Is your cord blood collected by:
A nurse midwife/obstetrician
Dedicated cord blood bank collector
GT5.
How many of each of the following product types were collected/processed at your
institution in 2010? [For purposes of the survey, autologous cord blood refers to familial
use in 1st or 2nd degree relatives.]
Collected
Autologous Allogeneic
a.
b.
c.
d.
e.
f.
g.
h.
Peripheral blood progenitor cell
collections (HPC-A)
Marrow collections (HPC-M)
Cord blood collections (HPC-C)
Donor lymphocyte infusion (DLI or
unmanipulated non-mobilized
peripheral blood mononuclear cells)
Immunotherapies (natural killer cells,
dendritic cells, T cells, and others, but
excluding DLI)
Hematopoietic stem/progenitor cells,
expanded
Nonhematopoietic stem cells
[mesenchymal stem cells (or multipotent
stromal cells per ISCT
recommendations), other]
Other products
20
Processed
See Glossary
GT6.
Indicate the number of infusion episodes and the number of patient recipients of cell
therapies by product type at your institution in 2010. [For purposes of the survey,
autologous cord blood refers to familial use in 1st or 2nd degree relatives]
Autologous
Infusions
Total No. of
Episodes
a.
Peripheral blood progenitor
cell products (HPC-A)
b.
Bone marrow products
(HPC-M)
Cord blood products (HPC-C)
Donor Lymphocyte infusion
(DLI or unmanipulated nonmobilized peripheral blood
mononuclear cells)
Immunotherapies (natural killer
cells, dendritic cells, T cells,
and others, but excluding DLI)
Hematopoietic stem/progenitor
cells, expanded
Nonhematopoietic stem cells
[mesenchymal stem cells (or
multipotent stromal cells per
ISCT recommendations) other]
Other Products
c.
d.
e.
f.
g.
h.
GT7.
Total No.
of Patients
Allogeneic
Infusions
Total No. of
Episodes
Total No.
of Patients
How many severe donor adverse events were reported to you in 2010?
__________________events
GT8.
How many adverse reactions were reported in 2010 in recipients of cellular therapies?
__________________allogeneic influsions
_________________autologous influsions
21
Thank you very much for your help!
Please return the questionnaire in the enclosed postage-paid envelope.
National Blood Collection and Utilization Survey
[INSERT RETURN ADDRESS HERE]
22
Survey Glossary
Autologous: self-directed donations.
Collected: successful whole blood or apheresis collections placed into production (not QNS, or other removals).
Community: in this survey refers to those allogeneic donations not directed to a specific patient.
Deferrals: The number of donors deferred for specific reasons:
A) Donors deferred for low hemoglobin do not meet the current FDA blood hemoglobin level requirements for blood
donation.
B) Deferrals for other medical reasons may include the use of medications on the medication deferral list, growth hormone from human pituitary glands, insulin from cows (bovine, or beef, insulin), Hepatitis B Immune Globulin
(HBIG), unlicensed vaccines, or presenting with physical conditions or symptoms that do not qualify a person to be
a blood donor.
C) High-risk behavior deferrals include deferrals intended to reduce the risk of transmission of infectious diseases
including HIV and hepatitis viruses. Examples of questions intended to identify these risks are sexual contact and
needle use questions.
D) Travel deferrals are deferrals for travel to a specific region of the world.
Directed: allogeneic donations intended for a specific patient.
Dose/Dosage: a quantity administered at one time, such as a specified volume of platelet concentrates.
FFP: fresh frozen plasma.
First-time donor: first time at your center
Modify: used in this survey to refer to procedures applied by a blood center, hospital blood bank, or transfusion service that may affect the quality or quantity of the final product (eg, irradiation, leukofiltration, or production of aliquots of lesser volume).
Plasma, frozen within 24 hours of phlebotomy: plasma separated from the blood of an individual donor and placed at
–18 C or colder within 24 hours of collection from the donor. Sometimes also referred to as FP24.
Plasma, Jumbo: for the purposes of this survey, FFP having a volume greater than 400 mL.
Present to Donate: A person presents to donate when he or she initiates the donation process through appearance and
registration at a donation site.
Processed: subjected, after collection, to any manipulation or storage procedure. One cellular therapy product can be
divided and processed in more than one way and would be counted as one collection but as two or more products
processed.
Recipient: A unique individual patient receiving a transfusion one or more times in a calendar year.
Released for Distribution: units that have fulfilled all processing requirements and have been made available for transfer to customers.
Severe Donor Adverse Events: adverse events occurring in donors attributed to the donation process that include, for
example, major allergic reaction, arterial puncture, loss of consciousness of a minute or more, loss of consciousness
with injury, nerve irritation, etc.
Transfusion Service: a facility that performs, or is responsible for the performance of, the storage, selection, and issuance of blood and blood components to intended recipients.
Tissue: Articles containing or consisting of human cells or tissues that are intended for implantation, transplantation,
infusion, or transfer to a human recipient, to include musculoskeletal tissue, skin, ocular tissue, human heart valves,
dura mater, reproductive tissues, tissue/device, and other combination therapies. Not included: vascularized human
organs, minimally manipulated marrow, xenografts, blood products, hematopoietic stem/progenitor cells, other cellular therapies, human milk, collagen, cell factors, in-vitro diagnostic products, and blood vessels (“conduits”) recovered with organs for use in organ transplantation.
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Survey Glossary
Autologous: Self-directed donations. Autologous cord blood refers to
familial use in 1st or 2nd degree relatives.
Collected: successful collections placed into production (not QNS, or other
removals).
Episode or Infusion Episode: infusion of one product type (eg, peripheral
blood stem cells) to a patient/recipient. The infusion episode may involve
infusion of one or more containers of that product type.
Modify: used in this survey to refer to procedures applied by a blood center,
hospital blood bank, or transfusion service that may affect the quality or
quantity of the final product (eg, irradiation, leukofiltration, or production of
aliquots of lesser volume).
Processed: subjected, after collection, to any manipulation or storage
procedure. One cellular therapy product can be divided and processed in
more than one way and would be counted as one collection but as two or
more products processed.
Severe Donor Adverse Events: adverse events occurring in donors attributed
to the donation process that include, for example, major allergic reaction,
arterial puncture, loss of consciousness of a minute or more, loss of
consciousness with injury, nerve irritation, etc.
Transfusion Service: a facility that performs, or is responsible for the
performance of, the storage, selection, and issuance of blood and blood
components to intended recipients.
24
| File Type | application/pdf |
| File Title | NBCUS Combined Rev0710.book |
| Author | NINA |
| File Modified | 2010-07-28 |
| File Created | 2010-07-28 |