bacterial interventions to increase blood safety · 2017. 9. 25. · contaminated blood donation....
TRANSCRIPT
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BACTERIAL INTERVENTIONS TO INCREASE BLOOD SAFETY
Jennifer AllenNational Bacteriology Laboratory
on behalf of
Dr. C P McDonaldHead of Bacteriology
National Bacteriology LaboratoryNHSBT
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Klebsiella oxytoca
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Overview• Risk of bacterial transmission• Sources of contamination• Organisms implicated• Interventions
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Contaminated Blood Donation
1. Self sterilising
~ 6 h
2. surviving but not growing
3. Growing to high levels, i.e. 108-12 cfu/ml
24 h DaysSlide adopted from Dr Thomas Montag †
10 - 100 bacteria per donation
Clinical Significance
Bacteria in Blood Components
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Bacterial Mortality WorldwideUSA 2005-2015 38 deaths (FDA)
France 1994-2015 36 deaths (Haemovigilance)
Germany 1997-2014 14 deaths (Haemovigilance)
U.K. 1994 3 deaths (Pre-SHOT)
U.K. 1996-2016 11 deaths (SHOT)
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• 44 cases• 11 fatalities (9 platelets, 2 red cells)• 37/44 (84%) involved PCs• Bacteria major cause TTIs and death
SHOT Reports (1996 – 2016)
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Platelet Components• Room temperature storage• Optimal for platelet viability and
function• Facilitates bacterial proliferation• Immunocompromised
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Platelet Components Are The Greatest Risk!
• USA: (FDA) 2005 – 2015 plateletcomponents comprised 87% (33/38)bacterial fatalities
• UK: (SHOT) 1996 – 2016 platelet components comprised 84% (37/44) cases
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Contamination of Blood Units
• Collection stage• During processing
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Collection• Asymptomatic bacteraemia in donor:(a) incubation or recovery period from
bacterial illness(b) chronic low grade infection(c) transient bacteraemia
• Inadequate disinfection of venepuncture site
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Organisms Implicated in Clinically Apparent Bacterial Transfusion
Reactions
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Organisms Implicated in Bacterial Transmissions from NHSBT Platelet
Components: 1995 - 2016Organism Frequency Potential Source Patient outcome
Gram Negative
Klebsiella pneumoniae 2 Gut Death (3)
Escherichia coli 2 Gut Death (1)
Enterobacter aerogenes 1 Gut Death (1)
Morganella morganii 1 Gut/Environment Morbidity (1)
Gram Positive
Staphylococcus spp. 16 Skin Death (2) Morbidity (14)
Bacillus cereus 4 Environment Death (1)
Streptococcus spp. 7 Nose and Throat/Gut Morbidity (7)
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Organisms Implicated in Bacterial Transmissions from NHSBT Red Cell
Components: 1995 - 2016Organism Frequency Potential Source Patient Outcome
Gram Negative
Pseudomonas putida 2 Environment Death (1)
Yersinia enterocolitica 1 Gut Death (1)
Enterobacter cloacae 1 Gut Morbidity (1)
Serratia liquifaciens 1 Gut Morbidity (1)
Gram Positive Staphylococcus sp. 1 Skin Morbidity (1)
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NHSBT Bacterial Transmission Prior to Interventions
•Platelet Components 22 cases (5 death)
•Red Cells 3 cases (1 death)
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Platelet Components:Pooled: 1 in 233 (0.43%)Apheresis: 1 in 257 (0.37%)Total: 1 in 242 (0.41%)Red Cell Components: 1 in 1235 (0.06%)
National Monitoring Study (1999 - 2000)
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Strategy• Improved donor arm disinfection• Diversion• Bacterial screening/Pathogeninactivation
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This image cannot currently be displayed.This image cannot currently be displayed.This image cannot currently be displayed.Improved Donor Arm Disinfection
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Donor Arm Swab Pre-Disinfection
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Bacterial Contamination at Venepuncture Site
NBL studies indicate:•50% donors have 105 organisms/cm2 (swab cup method)
•17% donors > 5000 cfu/plate (direct swabbing plating technique)
McDonald C.P. et al., Evaluation of donor arm disinfection techniques, Vox Sanguinis (2001), 80:135-141
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Potential Influential Factors of Bacterial Contamination at the Venepuncture Site
• Age• Gender• Occupation• Donor appearance• Amount of hair on site
NB: vigorous arm disinfection needs to be applied to all donorsMcDonald C.P. et al., The validation and monitoring of pre-venepuncture arm cleansing at NLBTC. Transfus Med 1994; 4:56
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Donor Arm Post-Disinfection
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Critical Factors for Donor Arm Disinfection
• Disinfectant or disinfectants utilised• Type of applicator utilised: sponge, swab, wipe,
gauze• Method of application:– One or two stage process– Time of application– Time of drying of the disinfectant– Mode of application
• Quantity of disinfectant dispensed
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Effectiveness of the Intervention of Improved Donor Arm
Disinfection
• Improved donor arm disinfection reduced bacterial contamination in apheresis platelet components in the order of 57%
• Reduction in clinically apparent cases by 65%
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Chloraprep® “Wand”Chloraprep® ‘Wand’
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Use of the Chloraprep®
Use of the Chloraprep®
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Diversion
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• National Bacteriology Laboratory Reduction 50%(NHSBT)
• France Reduction 72% (Vassout-Bruneau et al AABB 1999)
• Netherlands Reduction 82%(Olthuis et al, Vox.Sang.1996,70,2,113)
Comparison of Diversion Trial Studies
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Effectiveness of the Intervention of Diversion
• Diversion reduced bacterial contaminationin pooled platelet components in the orderof 66%
• Reduction in clinically apparent cases by76%
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Interventions Introduced• Improved Donor Arm Disinfection –
implemented nationally 2007• Diversion – implemented nationally 2003• In combination 77% reduction in
contamination
McDonald, C.P. et al., Relative Values of the Interventions of Diversion and Improved Donor-Arm
Disinfection to Reduce the Bacterial Risk from Blood Transfusion: Vox Sanguinis (2004), 86:178-182
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Two interventions implemented?
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Post Implementation Improved Donor Arm Disinfection and
Diversion (2006 – 2010)• 7 contamination incidents in PC• 10 patients affected• 3 deaths• 5 near misses
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Screening
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BacT/ALERT System
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BacT/ALERT Sampling
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BacT/ALERT System
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BacT/ALERT Culture Bottles
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Reflectance Measurement– LED illuminates sensor– Continuous monitoring:
bottles are read every 10minutes (144 times/day)
– Photodiode collectsreflected light
– Signal transmitted to computer
– “Reflectivity Units”plotted over time
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NHSBT Test Protocol (1 test, Extension Shelf Life to 7 Days)
1. Platelet components held for > 36h – 48h after collection
2. Platelet components sampled and tested3. Held for 6h (12h within building)4. Released with a 7 day shelf life5. Monitored for 7 days6. Positives recalled
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Bacterial Screening Sites:•Colindale•Filton•Manchester•Sheffield•Newcastle
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Quarterly Bacterial Screening Rates (February 2011 - June 2017)
0.00%
0.50%
1.00%
1.50%
2.00%
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3.00%
3.50%
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2011 2012 2013 2014 2015 2016 2017
Screening period
Rate
(%)
InitialReactive
ConfirmedPositive
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Initial Reactive and Confirmed Positive Rates(Cumulative February 2011 – June 2017)
Total Screened Initial Reactive Rate
Confirmed Positive Rate
Apheresis* 1,251,339 0.34% 0.02%
Pooled* 493,193 0.24% 0.07%
Total 1,744,532 0.31% 0.04%
*Apheresis platelets screened from Feb 2011*Pooled platelets screened from May 2011
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Confirmed Positives (February 2011 – June 2017)
• 618 confirmed• 595 Gram positives• 23 Gram negatives
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Confirmed Positive Gram Positive ‘Pathogenic’ Organisms (Feb 2011 – Jun 2017)
Organisms n IR Detection Time Range (h)
Total Contaminated Components
Streptococcus dysgalactiae (Group G/C) 23 2-19 26
Staphylococcus aureus 16 2-21 17
Streptococcus pneumoniae 12 9-13 16
Streptococcus agalactiae (Group B) 5 6-16 4
Listeria monocytogenes 4 14-20 5
Bacillus cereus 2 4-14 2
Total organisms: 62 Total components: 70
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Confirmed Positive Gram Negative ‘Pathogenic’ Organisms (Feb 2011- Jun 2017)
Organisms n Detection Time Range (h)
Total Contaminated Components
Escherichia coli 8 3-14 17
Serratia marcescens 3 4-13 5
Klebsiella oxytoca 3 3-9 4
Klebsiella pneumoniae 2 4-11 3
Pseudomonas aeruginosa 1 15 1
Campylobacter lari 1 32 1
Total organisms: 18 Total components: 31
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NHSBT Screening (February 2011 to June 2017)
• 1 transmission in >1.7million PC screened (S.aureus)
• 4 near misses (3 S. aureus and 1 S. marcescens)
• 1 CP in 6015 TE platelets screened (S. pneumoniae)
• False negative rate 1 in 349,000 (0.0003%)
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Implementation of Bacterial Screening by
NHSBT has been an extremely successful
risk reduction intervention!
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ConclusionIntroduced:• Improved Donor Arm Disinfection•Diversion•Screening
Future Consideration:•Pathogen Inactivation
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The Transmission of Bacteria by
Transfusion Remains a Significant Problem
in Transfusion Medicine
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Acknowledgements• Jennifer Allen• Su Brailsford• Rachael Morrison • Tracy Ward