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: 9. 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 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 11. Carolinas Cord Blood Bank STAFFED COLLECTION MODELS 12. Carolinas Cord Blood Bank STAFFED COLLECTION MODELS Collection room needed to: 1. Perform ex utero CB collection 2. Store supplies 3. Complete data entry 4. Store CBUs 5. Store confidential paperwork 6. Label maternal samples 13. Carolinas Cord Blood Bank PROS Dedicated staff Round the clock collections = satisfied donors and L&D staff Trained staff helps ensure compliance with regulatory issues Higher volumes Lower contamination rates CONSIDERATIONS Labor costs Staff recruitment and management Obtaining space for collections and supplies MD/Nursing/phlebotomy coordination and cooperation Staffed Collection Model 14. 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 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 20. 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 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 22. Carolinas Cord Blood Bank Kit Collection Site Model 23. Carolinas Cord Blood Bank Kit Collection Site Model 24. Carolinas Cord Blood Bank Kit Collection Site Model 25. 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 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.