Questionnaire for Initials - Scope of the Cord Blood Service v.6

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Cord Blood Questionnaire
Eligibility for AABB accreditation under the Cord Blood Activity is determined by I) the
scope of the facility’s business, and 2) what activities are contracted out, and
3) pre-screening for the facility’s ability to meet certain standards for which variances are
not usually granted due to safety issues.
1. Examples of Cord Blood Services that might be eligible for AABB accreditation. A
facility that performs: qualification of donors, collection, processing, storage,
distribution, and administration for transplantation, and is able to meet the
standards in section C.
2. A facility that performs cord blood processing and contracts out the collection and
administration to facilities that may or may not be AABB accredited, and is able
to meet the standards in section C.
Example of a Cord Blood Service that would not be eligible for AABB accreditation:
1. A facility that only markets, contracts with the OBGYN doctors and parents to
collect the cord blood, and contracts out the processing.
2. A facility that cannot meet the standards in section C.
Complete sections A, B, and C. Return by e-mail to [email protected] or by fax to
301-657-0957.
A. Locations
Number of sites (locations) where your facility’s employees perform the following
functions:
1. Number of collection facilities
2. Number of processing facilities
3. Number of transplant facilities
________
________
________
B. Scope
Facility’s name:
_________________________
Performed by
facility’s
employees
Yes or no
Contracted out
(if yes, list accrediting body,
AABB/equivalent)
Yes or no Accredited By:
1. Donor qualification
2. Collection of the cord blood
3. Processing of the cord blood
4. Storage of the cord blood
5. Distribution of the cord blood
6. Transplantation of cord blood
7. HPC, Cord Blood
Public
Yes
Private
Yes
Version 6
No
No
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Effective Date 3/10/2014
C. Pre-screening results of certain standards
Standard
1. Integral segments: Do you store the
cord blood products in bags or vials?
At your facility:
Bags ___________ Vials __________
All vial platforms are reviewed by the
Standards Committee to ensure the
integral segment requirement is met.
2. CD 34 counts: Do you perform CD34
counts on the product after processing but
before addition of the cryoprotectant?
Yes ______ No ____
If N/A explain why: ________________
Required.
3. Nucleated RBC counts: Do you
perform nucleated RBC counts or
corrected total nucleated cell counts on the
product after processing but before
addition of the cryoptotectant?
Yes ______ No ____
If N/A explain why: ________________
Required.
4. NAT Testing: Do you perform NAT
testing for HIV and HCV?
Yes ______ No ____
If no, would you be able to provide a
timeline for implementation? __________
If not currently performing, the
Standards Committee requires a
timeline for implementation.
Version 6
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Effective Date 3/10/2014
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