Hospitals, blood collection centers, cord blood banks

ATTACHMENT D

OMB Control Number
Expiration Date
ID:

2007 Nationwide 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 for the United States. The
data you contribute and the time you take to assure 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 new questions
regarding detailed utilization, therapeutic apheresis, 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 use our toll-free number:
800-793-9376.

Please return your completed questionnaire by September 15, 2007.

Statement on Confidentiality and Use of the Data:
The completed questionnaires will be processed and data compiled for analysis. No institutional data
provided in response to this survey will be released that allows a facility to be identified directly or
indirectly. De-identified data from this survey will be used by researchers throughout the blood
community. Results will only be released in aggregate form. The de-identified data and the reports will
be in the public domain, accessible to the public.

Instructions: Please read carefully!
•

Report all data for the calendar year 1/1/06 through 12/31/06 unless otherwise specified
(some questions are about current practices only). If your institution is not on the
calendar year 1/1/06 through 12/31/06, 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.

•

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 on
to another department for completion of some items.

•

Before you begin, read the glossary on the inside back cover of this booklet.

•

If you have any questions, please call the AABB toll-free Survey Helpline at 800-7939376.

•

Thank you in advance for your assistance with this important survey!

Section A. General Information
A1.

Provide the name, title, telephone number, and e-mail address of each person completing this
survey:

Name

Title/Position

Telephone

E-mail

___________________ ___________________ ___________________ ___________________
___________________ ___________________ ___________________ ___________________

1

A2.

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.
5 An independent facility that collects, processes, manufactures, stores, or
distributes cellular therapy products?

For Institutions 1-4 above:
Does your institution collect, process, manufacture, store, and/or distribute
hematopoietic progenitor cells (HPCs) or other cell therapy products? [If you
only perform infectious disease testing, please check “No”.]

… Yes
… No

BE SURE TO COMPLETE SECTION G

Does your institution collect, process, manufacture, store, and or distribute
human tissue for transplantation? [If you only perform infectious disease testing,
please check “No”.]

… Yes
… No

BE SURE TO COMPLETE SECTION F

2

A3.

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

A4.

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
3

Section B. Blood Collection, Processing, and Testing
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 2006?
[If a breakdown is not available, put the total under “Allogeneic Whole Blood”. Do not count
low volume or incomplete procedures.]
# of Procedures
Manual Whole Blood Collections
1) Community (Non-Directed Allogeneic Donations)…________
2) Autologous…………………………………………..________
3) Directed……………………………………………...________
# of Procedures

# of Products

Automated Collections
1) Red Cell Pheresis
a.
Allogeneic red cells…………….
b.

Autologous red cells…………….

c.

Directed red cells….…………….

d.

Concurrent plasma………………

e.

Concurrent plasma – jumbo……..

2) Platelet Pheresis
a.
Single Donor platelets…………...______
b.

Concurrent plasma………………

c.

Concurrent plasma – jumbo……...______

d.

Concurrent red cells……………..

______

3) Plasma Pheresis
a.
Source…………………………...
b.

Jumbo FFP (>400 ml)……………

c.

FFP……………………..………..______
4

______

B3.

How many units were processed by your institution in each of the following categories in
2006?
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

B4.

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 only be counted once.]
TOTAL

B5.

How many units of the following were produced from whole blood?
a.
b.
c.
d.

FFP………………………………………
Plasma, frozen within 24 hours…………
Plasma, cryoprecipitate reduced…….….
Jumbo size (> 400 ml)…………………..

_______________units
_______________units
_______________units
_______________units

B6.
Of the following components, how many units were produced by your institution in 2006?
[Count double or triple units resulting from double or triple collections or splits as two or three units.]
a.
b.
c.
d.
e.
f.
g.

Plasma for further manufacture…..…………………….._______________units
Whole blood derived platelets …………………………._______________units
Apheresis platelets from single collections [do not include autologous or
therapeutic units] ………………………………………._______________units
Apheresis platelets produced from double collections…._______________units
Apheresis platelets produced from triple collections ….._______________units
Cryoprecipitate ………………….………………………_______________units
Granulocytes...……………………..……………………_______________units

5

B7.

B8.

B9.

For each of the following categories, how many units did your institution
collect/prepare/modify to achieve pre-storage leukoreduction in 2006?
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 2006?
a.

First time allogeneic donors………….

donors

b.

Repeat allogeneic donors……………..

donors

In 2006, how many donors were deferred before donating?
___________donors

B10. In 2006, how many donors were deferred before donating based on their response to the
question regarding history of Chagas’ disease?
___________donors
B11. How many donations were from repeat allogeneic donors?
___________ donations
B12.

How many severe donor adverse events did you have in 2006?
____________ events

B13.

Are diversion devices used when collecting?
a.

Apheresis platelets?

… Yes
… No
… Don’t Know
b.

Whole blood?

… Yes
… No
… Don’t Know

6

B14.

Do you issue blood to home transfusion services, free standing surgery centers, or other offsite non-hospital transfusion services, such as dialysis centers?

… Yes
… No
… Don’t Know
If yes, how many units of:
a. RBCs
________________ units
b. Platelets ________________ units
c. FFP
________________ units
B15.

Do you issue blood for use by military installations?

… Yes
… No
… Don’t Know
If yes, how many units of:
a. RBCs
________________ units
b. Platelets ________________ units
c. FFP
________________ units
d. Cryoprecipitate____________ units
B16.

What was the total number of allogeneic units (non-directed and directed combined)
discarded in 2006 for any abnormal test results?
_________________units

B17.

For all tested donations collected by your facility in 2006, indicate the number of repeat
reactive and confirmed positive first- time allogeneic donors by infectious disease marker
below:

Infectious Disease Marker
a. Anti-HIV-1/HIV-2
b. Anti-HTLV-I/II
c. Anti-HCV
d. Anti-HBc
e. HBsAg
f. Serological test for Syphilis
g. HIV-1 NAT (antibody negative)
h. HCV NAT (antibody negative)
i. Undifferentiated NAT (if HIV-1 and
HCV discriminatory negative when
applicable)
j. WNV NAT
k. HBV NAT

# of Repeat Reactive
First-time Allogeneic Donors

7

# of Confirmed Positive
First-time Allogeneic Donors

B18.

For all tested donations collected by your facility in 2006, indicate the number of repeat
reactive and confirmed positive repeat allogeneic donors by infectious disease marker
below:

Infectious Disease Marker
a. Anti-HIV-1/HIV-2
b. Anti-HTLV-I/II
c. Anti-HCV
d. Anti-HBc
e. HBsAg
f. Serological test for Syphilis
g. HIV-1 NAT (antibody negative)
h. HCV NAT (antibody negative)
i. Undifferentiated NAT (if HIV-1 and
HCV discriminatory negative when
applicable)
j. WNV NAT
k. HBV NAT

# of Repeat Reactive
Repeat Allogeneic Donors

PLEASE GO TO SECTION C

8

# of Confirmed Positive
Repeat Allogeneic Donors

Section C. Blood Transfusion
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 2006, 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 # of
Units Transfused

C3.

Total # of
Recipients

Indicate below the total number of WB/RBC units transfused in each of the following
categories and report the number of recipients of these units.
Directed units
transfused to the
intended patient

Units transfused to
pediatric patients
(overlap possible)

Autologous units
transfused to
autologous donor

a. Number of units
b. Number of recipients

C4.

In 2006, 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, not pools]…………………………..____________ units

b.

Apheresis platelet units – full dose (≥ 3x1011)………………..____________ units

c.

FFP……………………..……………………………………..____________ units

d.

Plasma, frozen within 24 hours……………………………….____________units

e.

Jumbo plasma (>400 ml) …………………………………….____________units

f.

Plasma cryoprecipitate reduced………………………………____________units

g.

Pediatric size (100ml) single donor and/or fresh frozen plasma ___________units

h.

Cryoprecipitate AHF transfusion……………………………...___________units

i.

Cryoprecipitate used for fibrin sealant ………………………..___________units

9

j.
C5.

Granulocyte units ……………………...……………………...___________units

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 2006:
I.
Components
irradiated

II.
Components
leukoreduced before
or after storage
(not at bedside)

III.
Components
leukofiltered
at the bedside

a. WB/RBCs
b. Whole blood derived platelets
c. Apheresis platelets
d. Other blood component units,
including pediatric units

C6.

C7.

What percentage of blood usage by your facility went to the following departments in 2006?
a.

surgery - general

_________%

b

orthopedic surgery

_________%

c.

cardiac surgery

_________%

d.

trauma/ER

_________%

e.

oncology

_________%

f.

transplantation services

_________%

g.

obstetrics/gynecology

_________%

h.

pediatrics/neonatology

_________%

i.

nephrology/dialysis

_________%

j.

hematology

_________%

What is the average age of a unit transfused at your institution?
a.
b.
c.
d.

Red blood cells…………..……….____________days
Whole blood derived platelets……____________days
5 Day apheresis platelets…………____________days
7 Day apheresis platelets…………____________days

… Calculated Average
10

… Estimate

… Don’t know
… Don’t know
… Don’t know
… Don’t know

C8.

In 2006, 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]
…<5

C9.

…5

…6

…7

…8

…9

… 10

… >10

What volume of plasma is most commonly transfused during a single transfusion episode at
your institution?
_____________ ml

C10. How many grams of IVIG were used by your institution? [Include those issued by the
pharmacy in your count.]
________________ grams
C11.

What was the average dollar amount your institution paid per unit in 2006 for the following
components? [Include discounts in your calculations. A response of $0 should be entered as
“NA” rather than 0.]
Average
amount paid
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

$

f. Hematopoietic Progenitor Cells –
Apheresis

$

g. Hematopoietic Progenitor Cells –
Marrow

$

h. Hematopoietic Progenitor Cells – Cord $

11

C12.

Does your institution have an established “bloodless” surgery program (with a dedicated
coordinator)?

… Yes
… No
… Don’t Know
C13.

Does your hospital use intra-operative autologous blood recovery therapies?

… Yes
… No
… Don’t Know
C14.

How many days in 2006 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

C15.

On how many days in 2006 was your regular or standing order incomplete?
__________________ days

C16.

On how many days in 2006 were you unable to meet other non-surgical blood requests
(e.g. red cells, platelets)?
_________________ days

C17. How many WB/RBC crossmatch procedures were performed at your facility in 2006 by any
method?
_______________ procedures … Don’t know
If any:
a.

What percentage of crossmatch procedures performed would you estimate
used electronic crossmatch?
_____________________%

b.

What percentage of crossmatch procedures would you estimate were
performed serologically?
______________________%
12

C18.

How many transfusion-related adverse reactions were reported to the transfusion service in
2006? [Count the number of occurrences that required any diagnostic or therapeutic
intervention.]

… Don’t know

__________________events

If any events reported, complete the table below indicating how many of these were:
# of Occurrences

Event Description
a. Life threatening, requiring major medical intervention
following the transfusion, e.g. 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. Post Transfusion Sepsis
h. Severe Allergic Reactions?

C19.

Do you have an electronic system for tracking events (i.e. unplanned, unexpected, and
undesired occurrences)?

… Yes
… No
PLEASE GO TO SECTION D

13

Section D. Bacterial Testing
D1.

D2.

Does your institution perform bacteria 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

Swirling

pH

Glucose

Other

None

a. Apheresis Platelets?
b. WB Derived Platelets,
singly?
c. WB Derived Platelets,
pooled?

D3.

How many confirmed positives and false positives were detected by method in 2006?
Method

Number tested

# Confirmed Positive

a. Culture-based Methods
b. Alternative Method

PLEASE GO TO SECTION E

14

# False Positive

Section E. Special Procedures and Product Disposition
This section should be completed by all respondents.
E1.

Does your institution perform therapeutic apheresis procedures?

… Yes
… No
E2.

SKIP TO QUESTION E3

How many therapeutic apheresis procedures were performed for the following indications
in 2006?
# of Procedures
a.

Thrombotic Thrombocytopenia Purpura (TTP)…….._____________

b.

Guillain-Barré……………………………………....._____________

c.

Multiple sclerosis………………………………........_____________

d.

Sickle cell disease…………………………………..._____________

e.

Myasthenia gravis……………………………………_____________

f.

Hemochromatosis……………………………………_____________

g.

Chronic Inflammatory Demyelinating
Polyradiculoneuropathy…………………………….._____________

E3.

E4.

h.

Goodpasture’s Syndrome……………………………_____________

g.

Other…......................................................................._____________

In 2006, 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, O positive red cells, and O negative red cells (allogeneic,
non-directed) were outdated in 2006? 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.

O pos red cells outdated……………………………..______________ units

c.

O neg red cells outdated…………………………….

15

units

E5.

E6.

How many units in each of the following categories were outdated in 2006? 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.

Whole blood derived plasma ………........................._______________units

c.

Apheresis plasma …………………………………..._______________units

d.

Whole blood derived platelets ………………………_______________units

e.

Apheresis platelets ………………….........................._______________units

f.

Cryoprecipitate ……………………………………..._______________units

g.

Directed units ………………………........................._______________units

h.

Autologous units ……………………………………_______________units

At your facility, how many units of group O red cells do you use or ship on an average day?
_______________units

E7.

What is the average number of units in your hospital’s emergency trauma inventory (O
positive and O negative units)?
________________ units

E8.

… N/A

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

E9.

At your facility, what is the minimum number of units of group O positive and group O
negative red cells in uncrossmatched inventory considered to be “ideal”?
_________________units

PLEASE GO TO SECTION F

16

Section F. Cellular Therapy Products
Please give this section to the appropriate cellular therapy collection or laboratory
personnel to complete!
F1.

Does your institution collect, process, issue, or infuse hematopoietic progenitor cells (HPCs)
or other cell therapy (CT) products?

… Yes
… No
F2.

COMPLETE THIS SECTION
SKIP TO SECTION G

Choose which of the following best describes your program. Is your program a:

Blood center performing HPC collections only
Blood center.....collecting and 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 F4)
… HPC processing/storage facility within hospital (SKIP TO QUESTION F4)
F3.

Do you collect products for third party vendors (including cord blood banks NMDP, and
other suppliers of cellular therapy products)?

… Yes
… No
If yes, how many did you collect in 2006? [Check appropriate boxes below.]
HPC-A
Hematopoietic
progenitor
cellsApheresis

<10 per year
10-100 per year
100-500 per year
>500 per year

17

HPC-M
Hematopoietic
progenitor cells Marrow

HPC-C
Hematopoietic
progenitor
cells - Cord

Other

F4.

Are any CT products at your facility used for cardiology applications?

… Yes
… No
… Don’t Know
F5.

Does your program collect cord blood?

… Yes
… No
Is your cord blood collected by:

… A nurse midwife/obstetrician
… Dedicated cord blood bank collector
F6.

How many of each of the following product types were collected/processed at your
institution in 2006? [For purposes of the survey, autologous cord blood refers to familial use
in 1st or 2nd degree relatives]
I.
COLLECTED
Autologous
Allogeneic

a. Peripheral blood progenitor cell
collections (HPC-A)
b. Bone marrow collections (HPC-M)
c. Cord blood collections (HPC-C)
d. Donor Lymphocyte infusion (or
unmanipulated non-mobilized
peripheral blood mononuclear cells)
e. Hematopoietic stem/progenitor cells,
expanded
f. Immunotherapies (natural killer cells,
dendritic cells, T cells, other)
g. Nonhematopoietic stem cells
(mesenchymal stem cells (or
multipotent stromal cells per ISCT
recommendations),other)
h. Other products

18

II.
PROCESSED*
*See Glossary

F7.

Indicate the number of infusion episodes and the number of patient recipients of cell
therapies by product type at your institution in 2006. [For purposes of the survey,
autologous cord blood refers to familial use in 1st or 2nd degree relatives]
I.
Autologous
Infusions
Total #
of episodes

Total #
of patients

II.
Allogeneic
Infusions
Total #
of episodes

a. Peripheral blood progenitor
cell products (HPC-A)
b. Bone marrow products
(HPC-M)
c. Cord blood products (HPC-C)
d. Donor Lymphocyte
infusion(or unmanipulated
non-mobilized peripheral
blood mononuclear cells)
e. Hematopoietic
stem/progenitor cells,
expanded
f. Immunotherapies (natural
killer cells, dendritic cells, T
cells, other)
g. Nonhematopoietic stem cells
(mesenchymal stem cells (or
multipotent stromal cells per
ISCT recommendations)
other)
h. Other Products
PLEASE GO TO SECTION G

19

Total #
of patients

Section G. Human Tissue
G1.

Does your institution maintain an inventory of, or use human tissue for transplantation?

… Yes
… No
G2.

What department(s) are responsible for ANY OPERATIONAL ASPECT OF HANDLING
Human Tissue (i.e. ordering, receiving, storage, tracking, and/or issuance)? [Check all that
apply]

G3.

Operating Room
Blood Bank
Laboratory Medicine/Pathology
Hospital in-house Tissue Bank
Infection Control
Cardiology
Orthopedics
Dermatology
Ophthalmology
Specialty Dept, Other

What SINGLE department has the MOST responsibility for Human Tissue (i.e. ordering,
receiving, storage, tracking, and/or issuance)? [Check only one]

G4.

SKIP TO END

Operating Room
Blood Bank
Laboratory Medicine/Pathology
Hospital in-house Tissue Bank
Infection Control
Cardiology
Orthopedics
Dermatology
Ophthalmology
Specialty Dept, Other

In 2006, what was the total number of human tissue implants/grafts that your facility:
[Consult with Specialty Departments, if necessary, e.g. Orthopedics/ Dermatology/
Ophthalmology.]
a.

Used/implanted?.............____________

b.

Discarded? .....................____________

c.

Returned?.........................___________

20

G5. Do you maintain an inventory of human skin?

… Yes
… No
What was your average daily inventory of human skin in 2006?
____________square feet

G6.

In 2006 how many adverse events have been associated with human tissue implants/grafts?
___________ events

G7.

If available: [Please direct to the appropriate department e.g.: risk management, quality
assurance, etc.]
a. How many adverse events were related to viral transmission? _____ events
b. How many adverse events were related to bacterial infection? _____ events
c. How many adverse events were related to structural failure? _____ events

Thank you very much for your help!
Please return the questionnaire in the enclosed postage-paid envelope.
AABB
8101 Glenbrook Road Ste 1
Bethesda, MD 20814-9805

21

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.
Directed: allogeneic donations intended for a specific patient.
Dose/Dosage: a quantity administered at one time, such as a specified volume of
platelet concentrates.
Episode or Infusion Episode: infusion of one product type (e.g., peripheral blood
stem cells) to a patient/recipient. The infusion episode may involve infusion of one
or more containers of that product type.
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 (e.g. 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.
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.
22

Released for Distribution: units that have fulfilled all processing requirements
and are released 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.
Source Plasma: the fluid part of human blood collected by plasmapheresis and
intended as source material for further manufacturing use.
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 issuance: release of human tissue within a medical facility or institution.
Tissue recovery: the act of obtaining human cells and/or tissues intended for use
in clinical implantation, transplantation, infusion, or transfer.
Tissue storage: the maintenance of human cells and tissue for future use.

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