Validation of new blood bags for blood fractioning using reveos system by Susana G Gomez, head of Blood and Cell Processing Laboratory (Blood and Tissue Bank of Catalonia)

1. VALIDATION OF NEW
BLOOD BAGS FOR BLOOD
FRACTIONING USING
REVEOS SYSTEM
Dr Susana G Gomez
Head of Blood and Cell Processing Laboratory
Banc de Sang i Teixits
2017 AABB Annual Meeting
October 7th-10th 2017

2. I have no relevant financial
relationships to disclose for this
presentation.

3. LEARNING POINTS
1.Validation importance before implementing
any change
2.Setting validation protocol
3.Monitoring results after implementation.

4. 12 Satellite centers in contact with
the population (patients and
donors)
•Promotion and donations
•Transfusion
•Therapeutic aphaeresis
•Stem cell collection (patients and donors)
•Haemo and bio vigilance
One main center for
• Product elaboration
• Validation
• Storage and distribution
• Diagnostic analysis
• Administration
• Communication
BANC DE SANG I TEIXITS (BST)
BLOOD AND TISSUE BANK - INTEGRATION AND SUFFICIENT SAFE BLOOD

5. BLOOD COMPONENTS PROCESSING LAB
• Reveos system to process blood donations.
• 800-1000 blood donations processed/day
• Automated system
• Lean management on the production
laboratory

6. BLOOD COMPONENTS PROCESSING LAB

7. REVEOS 3 COMPONENT BLOOD BAG SET – 20340
(FORMER SET)
7
Red Blood Cell bag
Plasma bag
Platelet bag
Residual leukocytes bag
Whole Blood bag
450 mL ± 10%
plus 63 mL CPD
RBC
leukoreduction
filter Sample/diversion
pouch

8. REVEOS LR SET—4FG456S0 (NEW SET)
New Sampling System
Needle Injury Protection (NIP)
Terumo
Needle
Vinyl/Bags
~11%
Thicker
Vinyl
Tubing
~25% Thicker

9. NEW TERUMO BAGS VALIDATION
Initial validation
- June 2016
- New filter to evaluate
-Different centrifugation
settings (30ml vs. 60ml)
- 300 blood donation
- 75 platelet pools

10. NEW TERUMO BAGS VALIDATION
RBC HGB
(gr)
HCT
(%)
WBC
(10E6)
Vol
(ml)
Former set (n= 150-Dec 2015) 58 57.30 0.23 302
New bags (n=39) 58.61 57.60 0.08 307.55
Just 1 unit with the new bags had >1.1% haemolisis

11. NEW TERUMO BAGS VALIDATION
Plasma FVIII
(Ul/ml)
Vol
(ml)
WBC
(/uL)
Platelet
(10E3/uL)
Former set (n= 150-Dec 2015) 0.95 261.0 0.09 9.0
New bags (n=39) 0.87 261.46 0.10 18.0

12. NEW TERUMO BAGS VALIDATION
Platelets Platelet lost
(%)
Prefiltration selectin
(%)
Post filtration selectin
(%)
Current bag + new filter (median) 3.96 34.38 35.25
New bag + new filter (median) 3.53 31.16 36.08
New bag + new filter +
60 ml plasma (median)
3.49 28.03 29.30

13. Gradual implementation
-RBC & plasma: similar results pre & post implementation
-Platelets: improvement on Interim Platelet Units (IPUs) and
platelet recovery
NEW TERUMO BAGS IMPLEMENTATION

14. During implementation, an initial attrition and increase on errors
during processing has been experienced, and it’s been established in
the last months
NEW TERUMO BAGS IMPLEMENTATION

15. CONCLUSIONS
- We haven’t found any difference on the manipulation between
both bag sets
- We haven’t found any difference with platelet kit filter
- Better platelet recovery with new bag set
- Platelet pools have better performance
- New LR SET-4FG456S0 bag set has been implemented in all our
collection sites for better performance with no decrease on the
quality (quantitative and qualitative)

16. ACKNOWLEDGMENTS
BANC DE SANG I TEIXITS
- Robert Fernandez
- Lluis Puig
- Nuria Martinez
- Elena Valdivia
- Silvia Bertran
TERUMO BCT
- Jeff Blakeslee
- Susanne Marschner
All Blood Components Processing
Laboratory staff