1. Transfusion Services and Blood Center Partnerships
Theresa Dunning, MSQA, MT(aSCP)SBB, CQM/OE(ASQ)
May 6, 2017 CBBS Annual meeting

2. Disclosure
I have no relevant financial relationships to disclose

3. Learning objectives
1. Discuss why the FDA issued a large recall of leukoreduction filters in 2016
2. Review two ways blood centers responded to the recall in ways that would ensure adequate supply of leukoreduced red cells were maintained
3. Review inventory management at the hospital during the recall
4. Review how physician notification was performed

4. Key points for discussion
The need for effective communication and respect between the transfusion service and blood supplier
Developing and distributing a product management strategy with-in a large organization – quickly
Developing and sharing a process for physician notification and patient care – quickly
Keeping the transfusion services informed of new updates from the supplier – ability to change a process quickly

5. Ultimate Goal
Patient Safety
Safe and Adequate Blood Supply

6. Kaiser Permanente of Northern California
Kaiser Foundation Hospital (KFH) and The Permanente Medical Group (TPMG) deliver care to approximately 4 million patients in the northern California
There are 21 medical centers spanning a region from Fresno to Roseville in the north

7. KFH Laboratories – 21 Transfusion Services
Antioch
Fresno
Fremont
Manteca
Modesto
Oakland
Redwood City
Richmond
Roseville
Sacramento
Santa Clara
San Jose
San Francisco
South Sacramento
South San Francisco
San Leandro
San Rafael
Santa Rosa
Vacaville
Vallejo
Walnut Creek
Regional Laboratory (Reference laboratory)

10. The Complexity a Large Organization
Given the patient population supported and geographical spread of our hospital facilities several challenges were identified with this event
We contract with 3 different blood suppliers:
Blood Systems, Inc., (at the time of the event this represented Blood Centers of the Pacific (BCP) and BloodSource (BS))
American Red Cross
Central California Blood Center
Initially only BCP was thought to have distributed affected RBC units however, several BSI affiliates – including BS identified imported units that reached their customers

11. Transfusion Services Involved in the Recall
Antioch
Fresno
Fremont
Manteca
Modesto
Oakland
Redwood City
Richmond
Roseville
Sacramento
Santa Clara
San Jose
San Francisco
South Sacramento
South San Francisco
San Leandro
San Rafael
Santa Rosa
Vacaville
Vallejo
Walnut Creek
Regional Laboratory (Reference laboratory)

12. TPMG Laboratory Quality and Compliance
TPMG laboratory quality and compliance located in the Berkeley regional office provides interpretation and direction with regard to regulatory events
Given the volume of this recall event (approx. 1/3 nation’s LR RBC affected) and the number and size of our organization, active communication was maintained between the Blood Bank Practice Leader and the impacted blood suppliers
Blood Supplier(s)
Blood Bank Practice Leader
Transfusion Service Supervisors peer group
Transfusion Service Medical Directors peer group

13. Customer Communication
Blood Centers of the Pacific and BloodSource each scheduled conference calls with their hospital customers – transfusion service supervisors, quality, and medical directors
Our suppliers provided an explanation and action steps allowed by the FDA to avoid excessive RBC wastage
Strategies were suggested to ensure an adequate supply of RBCs would be available for patients requiring LR red cells
While new collection bags types were to be distributed, current inventory at the transfusion service needed to be used “appropriately”

14. Communication with Blood Suppliers
As the BB Practice Leader I attended both the BCP and BS customer conference calls within the same week
I requested that I be added on their customer distribution notification list so that I would receive the same information as mailed to our transfusion services
Additional notices and conference calls as the recall and transfusion service inventory management continued

15. Step 1 – Requalify by Testing
In April of 2016 the FDA issued a recall of leukoreduction filters due to variable performance in their ability to meet the requirements of leukoreduction (˂ 5 x 106 )
Initial recall efforts required the return of blood to the supplier if within the acceptance period for per unit residual WBC testing.
The transfusion services worked hand in hand with blood supplier until the blood remaining on the shelves could not be re-qualified as LR by testing

16. Step 2 – Inventory Management
Under the guidance of our blood suppliers TPMG NCAL LQC developed
1) Kaiser Policy developed for our Physicians covering:
Indications for LR products
Necessity of segregated inventories
Need to determine product distribution according to patient needs
At the medical center level, trauma and ED doctors agreed to use the non-LR RBCs on patients without LR indications
2) Kaiser Work instruction was implemented at our affected transfusion services to assist the CLS staff with a segregated inventory and patient distribution
Special tagging provided by the blood suppliers were used to visually segregate known LR RBC from recalled RBC

18. Recommended Patient Distribution
E0382 and E0379 RBC (considered non-leukoreduced)
E0382 and E0379 CMV negative but not LR
Leukocyte reduced RBCs- apheresis units, CPDA-1 units, units labelled “leukocyte reduction verified” or “new bag (SKU )”
Communication documented in BB LIS "OK to use non-leukocyte Reduced RBC per -Dr. X“
Each laboratory’s Transfusion Service Director had the final choice in accepting this recommendation
Patient Category
Products to be Used
Inpatient/Outpatient Oncology
Use leukocyte reduced RBC (#3)
Cardiac surgery or transplant candidate/post-
transplant (kidney, BMT, liver ,lung or any organ transplant), neonates
Antigen negative units for routine transfusion
Use leukocyte reduced RBC (#3) if available
Emergency Release, MTP or any trauma
Use segregated E0382 or E0379 (#1)
Other patients or questionable cases
Consult with transfusion director or designee

19. Other issues with product inventory
Recall listings were initially a preliminary list due to the additional time to trace and identify where imported products came and went
Second wave of recall listings
Receiving blood from suppliers that may not exist in our LIS system:
W3336- Mississippi- these units are not affected and are OK to use as leukocyte reduced.
Re-instatement of non-LR product codes in work flow for awareness:
E0366 and E0273 CP2D /AS3 - not leukoreduced.

20. Step 3 – Look Back Do we need to do look back?
When does look back start?
Can we start now?

21. Step 3 – Patient Look Back
Our Blood Suppliers sent the lists of affected products directly to our transfusion services. I also requested a copy of what was sent out to assess the extend of the look back effort
PDF file listings were requested to be provided in Excel format to allow sorting and commenting directly into the file for use as a tracking log with patient MRN

22. TPMG BB Physician Sub Group
Look Back process conference scheduled via WebEx
5 -7 Transfusion Service Directors
2 – 3 Transfusion Service Supervisors
BB LIS System Coordinator
Ideas were generated among the MD peers with regard to case file review and provider notification using the ERM messaging function

23. Step 3 – Patient Look Back
Laboratory Quality and Compliance developed a regional Look Back policy / procedure for this recall event – incorporating in-put from the Transfusion Service Directors
LQC Regional Laboratory associate Director – customized our physician notification letter using the Blood Supplier template at a starting point
Both BCP and BSI provided physician notification letters as part of patient look back to assist the transfusion service medical directors with any questions from the notified physician.

24. Step 3 – Patient Look Back
In addition to the physician notification letters:
BCP also provided a table “Main Risks of Non-Leukoreduced Blood Transfusion and Monitoring Strategies for Selected Patients”.
The guidance provided a quick guide by
Patient category | Main risk of non-LR transfusion | Patient Monitoring
Transfusion transmitted CMV typically occurs 2-8 weeks after transfusion (although shorter and longer time intervals have also been described)

29. Laboratory Quality and Compliance
Requires a completed file of all recalls that affect the laboratory – reagents, instruments, blood products.
Tracks recalls for assessment of the vendor and any detected trends
Verifies return to normal operations
Survey conducted to determine regional impact and task completion

30. Post Recall Statistics Survey
Region-wide Quality Measure
Totals
Affected products
1000
Non-conforming products transfused
80%
Units included in look back 2%
Units recovered for acceptable use
14%

31. Summary
Blood supplier medical directors provide expertise in transfusion medicine. They are able and willing to guide transfusion service supervisors and directors through complex technical issues
Accepting their guidance will frequently expedite finding the best solution
Interactive communication supports the process of learning and succeeding in reaching a common goal as illustrated in this case study

32. Acknowledgement of Appreciation
Blood Centers of the Pacific
Pandey Suchii, MD
Salima Shaikh, MD
Tawny Allen – Patient Services
BloodSource
Chris Gresens, MD
Jonathan Hughes, MD
Dave Fisher – Client Services
Nancy Finn – Client Services