Optimizing Tissue Management in Blood Banks: Regulatory Compliance and Operational Efficiency

1. Tissue Management Using SoftBank Terri Bostock, Blood Bank Manager, ORMCBrenda Duff, Clinical Lab Technologist, ORMC

2. Reasons Blood Banks are Taking over Tissue Management

3. Regulatory Agencies The regulatory agencies that are responsible for governing tissue compliance: • FDA • The Joint Commission • AABB • CAP • AATB • EBAA • State Dept of Health

4. Regulatory Requirements

5. AABB Survey Article about Hospital Oversight of Tissues Changes in Hospital Human Tissue Oversight in the United States between 2005 and 2011: Results of a Follow-up of AABB Survey. Transfusion Vol 54, Issue 1, pp. 224-230, Jan 2014 Background: In 2005 the Joint Commission started to regulate tissues. This follow up survey looked at progress since then, surveying 1069 hospitals in 2011. Results: 336 total responses. The Department of Surgery had responsibility of tissue storage and distribution, followed by the Blood Bank. Since 2005, more Blood Banks have become responsible for more types of tissue and also for reporting adverse events. Cord blood and stem cell management were also increasing in the Blood Bank.

6. AABB Survey Article about Hospital Oversight of Tissues Conclusion: Blood Banks are more involved in the regulatory aspects of human tissue oversight and remain involved in many operational aspects of hospital tissue management.

7. Giddyup!!!! Soft Bank already has what we need to document tissues, we just have to learn what needs to be worked around and improved because the system was not designed with the intention of tissue tracking. THE BUILD!

8. Building the Tissue as a Blood Product

9. Main Product Codes • EYE- Eye products • SKN- Skin products • CARD- Cardiac products • MSK- Musculoskeletal products • SEAL- Sealants

10. Building the Tissue as a Blood Product

11. Building the Tissue as a Blood Product

12. Building the Tissue as a Blood Product

13. Be sure to build it in Lab too!

14. Building the Tissue as a Blood Product • Don’t forget to do “Setup Check” to check for any missing elements in your build. • Build in TEST area first, then LIVE. • Keep screenshots of each tissue built, or capture on Camtasia, etc. • Validate in TEST area thoroughly.

15. What’s next??? THE WORK FLOW…….

16. Delivery of Tissues

17. Duplicate lot numbers

18. Adding a suffix

19. Volume must be entered whether defaulted or not.

20. “Blood Product Order”

21. Select the Tissue

22. Issue from Menu Select F7

23. No ABO/RH testing 

24. Fill in the required fields

25. Tissue Issue

26. Supply Option Tissues can be built as a supply however, there are certain things that can not be documented as easily as if it were a blood product. • Arrival Temperature • Package integrity • Recalls • Quarantine • Return to supplier *Much more flexibility to build them as blood products

27. SOFTBANK Limitations • The most recent version of Bank allows 16 characters for the product number. We currently need as many as 21. • Tissues are not yet mandated to be ISBT labeled. This means typing in unit numbers twice if HOSPARAMS are set that way. • Exceptions when they are set up as blood products because of not having a blood type on file. • In some ways setting tissues up as supplies like RhIg would be better but the documentation would not be as detailed.

28. Limitations cont’d • Some tissues have the same lot number for MANY different tissues which leads you to have to add a suffix. We have even gone through the entire alphabet and had to add A to the lot number and THEN a suffix on top of that. ISBT labeling will correct this. • Temperatures can be acceptable at >-99C soft will only allow -99C or warmer due to character limits. • SoftBank requires a temperature range, some tissues only say “ambient”. • Have to default a volume of 1mL for all tissues.

29. QUESTIONS