Evaluation of Compomat G5 and CompoFlow concept in the routine of HEMOMINAS Foundation. Flavia Naves Givisiez Quality Control Manager

Transcription

1 Evaluation of Compomat G5 and CompoFlow concept in the routine of HEMOMINAS Foundation Flavia Naves Givisiez Quality Control Manager

2 Brazil: Brazil is the biggest country in Latin America It has 26 states and 1 federal district 3,287,597 miles square 189,612,814 inhabitants Blood Establishments and policies are governed by the Ministry of Health

3 Minas Gerais: Minas Gerais is the fourth largest state (586,528 km² = 226,460 miles square ) It has 20,033,665 inhabitants 853 counties HEMOMINAS Foundation is a public institution: network of blood establishements, with a centralized administration and technical coordination The Hemominas Foundation of Brazil: Quality Management in a Hybrid Model, in: Strategies for Centralized Blood Service, p AABB PRESS, 2006.

4 HEMOMINAS Foundation: has 20 blood collection units distributed all over the state (collection, blood components preparation and distribution) is responsible for 90% of the required blood in the state supplies 450 hospitals and clinics

5 HEMOMINAS Foundation - Year 2011 Whole Blood donation: 274,758 Blood components prepared: 754,709 Plasma sent to industry: 69,387 units

6 Preparation of blood components from Whole Blood Up to 2008: PRP methodology 97,6% of collections Manual extraction BC-single methodology only at HBH New structure that was implemented as of 2009: BC methodology (pool and single) in four sites of HF Automated extraction

7 Compomat G4 Automated Extractor Plasma Buffy Coat RBC SAG-M

8 Separation of Buffy Coat

9 Preparation of blood components from Whole Blood Reasons for choosing BC methodology : Increase in plasma volume Proteins and leucocytes reduction in RBC Widely used in the world Large scientific literature Reasons for choosing pool-bc methodology : Easy to standardise Adequate recovery of platelets The technic is easy to execute Therapeutic dose for adults Stock management

10 Annual estimate of Whole Blood collection HBH JFO UDI DIV MOC HEMOMINAS Foundation: approx 275,000 collections per year URA GOV PAL HJK BET SLA PAS PMI PNO SJR MÇU POC ALP DIA ITU

11 HEMOMINAS Foundation BC BC BC BC

12 Validation of BC-pool methodology Results of 126 platelets from BC-pool HBH Platelets (x ) per unit ± 5.40 ( ) ph 7.18 ± 0.11 ( ) Volume (ml) ± ( ) Results of validation of 126 platelets pooled from buffy-coat - HEMOMINAS / HBH Ano 2009.

13 Plasma discarded due to insufficient volume (<170 ml) Before and after implementation of BC methodology Years 2008 and 2010, respectively Sites Before BC - Year 2008 After BC - Year 2010 Production of plasma Discharge of plasma (% of production) Production of plasma Discharge of plasma (% of production) HBH 63,295 23,493 (37.1) 66,997 8,737 (13.0) JFO 24,943 8,684 (34.8) 26,274 5,693 (21.7) UDI 17,467 9,302 (53.3) 18,.292 3,493 (19.1) TOTAL 119,485 43,675 (39.2) 124,235 21,180 (16.1)

14 Compovision: plasma volume BC methodology 31-May-12

15 Compovision: plasma volume PRP methodology 30-June-12

16 Distribution of preparation methodologies at HEMOMINAS From March 2011 to March 2012 Automated extraction PRP Manual (automated)

17 Proposals for this year Expand automated extraction and BC methodology at HF (3 more units) Planning of a new project: regional platforms to prepare blood components The Brazilian legislation until last july-11 demanded the WB processing at most in 8 hours after collection

18 COMPOFLOW and COMPOMAT G5

19 Detection of an increase in hemolysis rate RBC (buffy-coat removed with aditive solution) 50% 40% 30% 20% 10% Percentage of non-conformity on hemolysis tests GOV Year % Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Nov/2010: some RBC with visible hemolysis

20 Investigation of probable causes of hemolysis Excessive extraction time = from the same operator Gkoumassi E - Hemolysis of red blood cells during processing and storage Transf 2011

21 Compoflow and Composure RETRAINING FOR BREAKING THE SEAL: EXCELLENT RESULTS, similar to Composure + Compoflow Serrano K, Levin E, Culibrk B, Weiss S, Scammell K, Boecker WF, Devine DV: Performance characteristics of a novel blood bag in-line closure device and subsequent product quality assessment. Transfusion 2010; 50:

22 VALIDATION COMPOMAT G5 + COMPOFLOW COMPOMAT G4 + CONVENTIONAL BREAK-OFF

23 Comparison: Compomat G5 Compomat G5 + CompoFlow sealing Compomat G4 + bags with conventional sealing Questions: Reduction of hemolysis rate in RBC? Improvement in platelet recovery at the second extraction? Increase in plasma volume? Decrease in extraction time?

24 Higher rate of platelets recovery?? Compomat G5 offers the opportunity of manual sealing at Head 2

25 Tests protocol 100 CompoFlow bags processed at Compomat G5 (pool BC) 100 bags with standard break-off, at processed Compomat G4 RBC: hemolysis Platelets (pool BC from 5 donors): platelets counting Plasma: volume Time processing (first stage) Periods of validation: Oct and Nov-11 ; April and May-12

26 Whole Blood CONVENTIONAL BAGS COMPOMAT G4 COMPOFLOW COMPOMAT G5 VOLUME (ml) 450±10 450± PLATELET (x10 10 /unit) 10.9± ± SAMPLE SIZE p

27 Platelets (pool BC 5 donors) COMPOMAT G4 COMPOMAT G5 p VOLUME (ml) 280±33 244± PLATELET (x10 10 /unit) 35.6± ± SAMPLE SIZE 16 13

28 Red Blood Cells COMPOMAT G4 COMPOMAT G5 p VOLUME (ml) 283±20 279± HEMOGLOBIN (g/unit) 52±7 56± HEMOLYSIS (%)- Day ± ± HEMOLYSIS (%)- Day ± ± HEMOLYSIS (%)- Day ± ±

29 Plasma COMPOMAT G4 COMPOMAT G5 p VOLUME (ml) 220±19 230± SAMPLE SIZE 99 96

30 Average processing time 1st stage of extraction Compomat G4 X Compomat G5 - Compovision Decrease in approximately 20%

31 Conclusions CompoFlow: Great acceptance among operators: Absence of repetitive effort of breaking-off Compomat G5: Great acceptance among operators: simplified alarms, reduction in extraction time

32 Conclusions Preliminaries results suggest: Reduction in extraction time at Compomat G5 Increase in plasma volume Higher platelet recovery Avoidance of the risk of RBC hemolysis caused by operator s errors

33 BELO HORIZONTE: 70,516 blood collections (2011) Next steps

34 Proposals 2nd semester 2012: CompoFlow at HBH Compomat G5 (10 machines) at HBH Implemention a platform of preparing components, receiving the WB bags from 3 other blood collection sites

35 Acknowledgements Team of Preparation of Blood Components HBH Team of Quality Control of HF Team of GOV (Alessandra Miranda) Team of JFO e UDI Dra Junia Mourão Cioffi Dr Fernando Basques

36 Thank you! Unit of Belo Horizonte - HEMOMIONAS Foundation: preparation of blood components