Buffy Coat Platelet Production Project – Changes to Blood Components for Hospitals

1. Buffy Coat Platelet Production Project – Changes to Blood Components for Hospitals September 2008

2. What is a Buffy Coat ? • A layer of mixed white cells and platelets created by high speed centrifugation of whole blood • It is neutral or buff in colour • Contains: most of the white cells and platelets and ~ 10 % of RBC

3. BuffyCoat– AroundtheWorld Countries where the Buffy Coat production method is predominantly used for the preparation of platelets derived from whole blood

4. CurrentPRPMethod Step 1: Whole blood centrifuged at low speed (soft spin) to produce two layers – Red Cell and PRP Step 2: PRP extracted from top of pack, passing through leukoreduction (LR) filter Plasma (PRP) Red cells

5. Key Benefits – cooling trays • Increase in time allowed for component production (24 hours vs. 8 hours) through the use of a rapid cooling technique • improves availability of platelets

6. Transport of Blood From Mobile Clinics

7. Manual Component Separation

8. Buffy Coat Method Whole Blood is collected into a top and bottom pack and is centrifuged (hard spin) to produce platelet poor plasma, red blood cells and a buffy coat Platelet Poor Plasma Buffy Coat Layer Red Cell Concentrate Red Cell Additive (SAG-M)

9. Vancouver, CBS Production Site

10. Simultaneous extraction of Red Cells and Plasma

12. Sterile Docking of 1 unit of Plasma to 4 Buffy Coats

13. Pooling Process

14. Comparison of PRP & BC Methods

15. Why switch to the Buffy Coat method?

16. Key Benefits – automated extraction • Computer-controlled extraction allows for increased process control better quality product more consistent recoveries therefore more consistent platelet dose higher percentage of platelets recovered per donation

17. Key Benefits – sterile docking • Hospitals receive a pooled platelet concentrate that has been produced in a closed system. • Less donor exposure for recipients – 4 donations pooled instead of 5 • Product is pooled in plasma from male donors whenever possible to reduce the risk of TRALI

18. Bacterial Detection of Pooled Platelets • Pooled product tested by Canadian Blood Services using the BacT/ALERT method currently used for apheresis platelets and PRP platelets.

19. Benefits for CBS = Benefits for Hospitals • Increased volume of Recovered Plasma • approx. 70-80 mL/donation • reduces Canada’s dependency on open market IVIG, improving security of supply and reducing overall cost to the health care system

20. Impacts For Hospitals • One anticoagulant Citrate Phosphate Dextrose(CPD)and one red cell preservative Saline Adenine Glucose Mannitol(SAGM) • New Product names – SAGM Red Cell Units, CPD FP24 and CPD Platelets Pooled • No longer produce FFP from Whole blood. • Plasma frozen within 24(CPD FP 24) hours of collection will be available.

21. Impacts For Hospitals • No labelling claim for leukoreduction in frozen plasma products. • Red blood cell bags are slightly more fragile. • 2 units SAGM pediatric red blood cell units vs current 3 units of AS-3 pediatric red blood cell units. • Maybe fewer rbc segments than current bags. • Different seal between segments. Scissors recommended to cut segments.

22. Impacts For Hospitals • New boxes for the storage of frozen product will be I inch longer • Autologous CPDA-1 Whole Blood Units will not be available. Autologous SAGM Red Blood Cell Units with 42 day expiry will be produced. • New autologous disposition form • CPD FP24 will only be issued to hospitals if the physician completing the Autologous Request Form requests CPD FP24. • Cryoprecipitate/Cryosupernatant produced from FP – no longer labelled as AHF

23. Impacts For Hospitals • Mixed Inventory SAGM rbc units &CPD plasma products and AS-3 rbc units & CP2D plasma products • Frozen products have one year shelf life • Imported products from Saskatchewan CBS • 2 Circulars of Information required • 2004 pre-buffy coat and 2005 New Products with Buffy Coat Implementation

24. New Product Labels

26. Impacts For Hospitals • New storage container for platelet pools • Bag dimensions 257mmx 170mm • Collection date on CPD Platelets, Pooled is the ‘Pooled’ date rather than the collection date. • CPD Platelets, Pooled have 5 day shelf-life from date of collection of the whole blood

27. Impacts For Hospitals • Volume is on the CPD Platelets, Pooled label • Platelets may slip off some flat bed agitators.

28. New Product Labels

29. Impacts For Hospitals • Some hospitals have reported issues with spiking infusion sets into SAGM RBCs, LR • The ports on both the Baxter and MacoPharma bags are designed to an ISO standard. • Important to use proper spiking technique • Important to trial both blood administration sets and transfer sets used in hospital • Customer Feedback: • Depending upon the infusion set being used and the method used for spiking, experiences are different

30. Spiking Method Do not over-spike!

31. Need More Information? • Additional information can be found on the Internet sites http://www.blood.ca http://www.transfusionmedicine.ca • Customer Letters • Posters • Presentations