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Cord Blood Collection Models
1. Carolinas Cord Blood Bank
CORD BLOOD COLLECTION
MODELS
Robin Smith Berger RN BSN
Collection Site Coordinator
Carolinas Cord Blood Bank
Duke University Medical Center
June 5, 2013
Challenges and Solutions
2. Carolinas Cord Blood BankCarolinas Cord Blood Bank
CB COLLECTION MODELS
1. Fully staffed collection sites
2. Hybrid Collections (Staff/OB providers)
3. Kit Collection Programs:
Fixed kit collection sites
Remote kit collections
Each model has pros and cons
The success of a given model can vary
between sites
3. Carolinas Cord Blood BankCarolinas Cord Blood Bank
Cord Blood Collection & Banking
1. Must be collected by trained personnel
In utero
Ex utero
2. Must meet all regulatory requirements
IND
FDA license
3. All banked units must meet all defined specifications:
Volume, cell counts, viability
Maternal ID testing and Medical History
Test results: Sterility, hemoglobinopathy screening, etc.
Requirements
4. Carolinas Cord Blood BankCarolinas Cord Blood Bank
4. Monitoring of:
Critical supplies
Shipping
Chain of custody documentation
5. CB processed and frozen within 48 hours of collection
Cord Blood Collection & Banking
Requirements
5. Carolinas Cord Blood Bank
Donor Eligibility
> 18 years
> 34 weeks gestation
Singleton pregnancy
Negative HIV, Hep B and C, CMV, HTLV 1&2
No congenital defects
No high risk behaviors
No active STD/IDs
Negative genetic history for blood and immune
system diseases
Cord Blood Collection & Banking
6. Carolinas Cord Blood Bank
Donor Recruitment
Recruitment is not an issue
Mothers want to donate
Donations are possible with any delivery method
No risk to mother or baby
No cost to donor
May be selling point for hospital in competitive
markets
Cord Blood Collection & Banking
7. Carolinas Cord Blood Bank
All Collection Models
Donors must complete or provide:
1. Consent form
2. Maternal risk questionnaire
3. Family medical history
4. Maternal samples
CB COLLECTION MODELS
8. Carolinas Cord Blood Bank
1. Must complete &
document training and
annual credentialing
2. Ship units and samples to
lab in time to process, test
and cryopreserve
All Collection Models
CB COLLECTION MODELS
OB/CNM or cord blood staff:
10. Carolinas Cord Blood Bank
1. Dedicated space
Requirements
STAFFED COLLECTION MODELS
2. Running water
3. Good lighting
4. Internet access
5. Easy to clean walls & surfaces
6. Temperature & humidity monitoring
Preferably in the L&D area
15. Carolinas Cord Blood Bank
Combination of MD and Staffed
Models
CB Staff collects in or
ex utero during
business hours
MD/Midwife collects in
utero after hours
CBB staff with L&D staff:
− Recruit
− Consent – mini and full
− Collect CB and maternal samples
− Follow up
− Ship for processing
− Leave kits for donors after hours
MDs and Midwives
− Recruit
− Consent via mini-consent
− Collect CB in utero
− Complete delivery paperwork
Hybrid Collection Model
16. Carolinas Cord Blood Bank
In utero collection
Collection bag
Hybrid Collection Model
17. Carolinas Cord Blood Bank
PROS
Potentially available to all
donors all the time
CBB performs On site
training of MD/CNM staff
CBB staff prepare kits ,
triages and ships
potentially bankable units
CBB staff completes f/u
and reviews paperwork for
accuracy
Chain of custody may be
problematic
Competing
responsibilities for OB
providers
MD/CNM training
requirements
Lower collection volumes
lead to higher collection
costs
CONSIDERATIONS
Hybrid Collection Model
18. Carolinas Cord Blood BankCarolinas Cord Blood Bank
CCBB COLLECTION MODELS
-
10.00
20.00
30.00
40.00
50.00
60.00
70.00
80.00
90.00
100.00
2011 2012 2013 Q1
Avg Vol by Collector Type
STAFF Avg
MD Avg
KIT Avg
Note: Includes Kit collectionsNote: Includes Kit collectionsNote: Includes Kit collectionsNote: Includes Kit collections
19. Carolinas Cord Blood Bank
Challenges
Not all MDs supportive
No compensation for
time and effort
Lower volume
collections
Requires processing
laboratory to open 7
days per week to
prevent units from
expiring
Solutions
Educate and acknowledge
RNs and MDs for
consenting and collecting
− Commitment to mission
− Certificates and other
acknowledgements
− Ties to successful patient
outcomes
Promote competition
between providers for
largest collection
Hybrid Collection Model
21. Carolinas Cord Blood Bank
Fixed Kit Collection Site
Hospital-hired coordinator
CBB provides training to staff
CBB provides collection supplies
OB techs and RNs collect ex utero
MD/CNMs collect in utero
Kit Collection Site Model
26. Carolinas Cord Blood Bank
Remote Kit Collections
1. Donor driven
2. Recruitment by:
Word of mouth
Online searches
Media
MD/CNM offices
3. Screened by CBB by phone
4. Kits shipped directly to donor
Kit Collection Model
27. Carolinas Cord Blood Bank
Kit Collection Model
5. MD/CNM agrees to pro bono
collection
6. MD/CNM completes online
training
7. Donor returns completed
paperwork & samples to CBB
8. CBB completes follow up
Remote Kit Collections
28. Carolinas Cord Blood Bank
Challenges
1. Low volume
2. Expired units
3. MD Training
4. Paperwork errors
3: Kit Collection Model
CB COLLECTION MODELS
Numerous donated
units are discarded
29. Carolinas Cord Blood Bank
CCBB Kit Program Exclusions
Low Volume
39%
Expired
24%
Other
20%
Insufficient cell
count or low
viability
11%
MD Training
2%
Positive
ID
0.2%
Contamination
rate
4% Low Volume
Expired
Other
Insufficient cell count or low
viability
MD Training
Positive ID
Contamination rate
30. Carolinas Cord Blood Bank
Solutions
1. Improve messaging
2. Centralize:
Donor screening
Donor eligibility determination
Kit distribution
3. Improve shipping times
Kit Collection Model
4. We believe a
national program is
needed!
31. Carolinas Cord Blood Bank
Collection kits ready to ship to donors!
Recruitment for public banking is NOT an issue
Interest in donating is HIGH!
Kit Collection Model
32. Carolinas Cord Blood Bank
What makes the difference?
1. Diversity of donors
2. Healthy donors
• Low risk
• Term deliveries
CB COLLECTION MODELS
Recruit the Right Site!
33. Carolinas Cord Blood Bank
What makes the difference?
1. High birth rate
2. Healthy maternal-baby
populations
• Low risk
• Term deliveries
CB COLLECTION MODELS
OB provider and hospital commitment,
passion and buy-in are critical
Recruit the Right Sites!
34. Carolinas Cord Blood Bank
What makes the difference?
Create awareness among hospital staff
Grand rounds
Staff meetings
Include all players
L & D
Phlebotomy
Post partum
Thanks and recognition
CB COLLECTION MODELS
OB provider and hospital commitment,
passion and buy-in are critical
Recruit the Right Site!Educate & Reward!
35. Carolinas Cord Blood Bank
What makes the difference?
Recognize institutional & cultural differences
Understand the community
Planning
Create awareness among hospital staff
Grand rounds
Staff meetings
Include all players
L & D
Phlebotomy
Post partum
Thanks and recognition
CB COLLECTION MODELS
Educate & Reward!
36. Carolinas Cord Blood BankCarolinas Cord Blood Bank
CB COLLECTION MODELS
1. Fully staffed collection sites
2. Hybrid Collections (Staff/OB providers)
3. Kit Collection Programs:
Fixed kit collection sites
Remote kit collections
Each model has pros and cons
The success of a given model can
vary between sites
37. Carolinas Cord Blood Bank
THANK YOU!!!
To all the donors and the
collectors of cord blood
everywhere.
This work was made possible
through the Carolinas Cord
Blood Bank.
Thanks to HRSA for their
ongoing support through the
NCBI.