Transcript Update on the Standards and bacterial contamination of

Update on the AABB
Standards and
platelet bacterial
contamination
TAC: MVRBC 2011
Standard 5.1.5.1
• The blood bank or transfusion service
shall have methods to limit and to detect
or inactivate bacteria in all platelet
components.
• Standard 5.6.2 applies.
–Venipuncture skin prep and diversion
Association Bulletin 09-04
“…after publication of data sufficiently robust…the
current standard will be reappraised. At that time,
AABB intends to promulgate an interim standard to
require enhanced methods of bacterial detection in
WBD platelets—either by specifically prohibiting the
use of less sensitive methods such as pH or glucose,
or by establishing a minimum sensitivity level for
methods used to detect bacteria.
• At this time, transfusion services using uncultured
WBD platelets should begin to consider their options.”
Interim Standard 5.1.5.1.1
• Detection methods shall either be
approved by the FDA or validated to
provide sensitivity equivalent to
FDA-approved methods.
Effective date of January 31, 2011.
FDA fatality surveillance FY 2005-10
40
35
FY05
30
FY06
25
FY07
FY08
20
FY09
15
FY10
10
5
0
Bacterial deaths reported to FDA
7
6
RDP
Apheresis
5
4
3
Average 2001-05 = 6/year
2
1
0
2005
2006
2007
2008
2009
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/
TransfusionDonationFatalities/ucm204763.htm
Contamination rate/106 based on early (release)
culture: optimal arm prep and diversion pouch
1200
1000
1000
800
800
640
648
600
400
211
200
0
Corash, L. Expert Rev. Heme. 2011
855
900
Rates/106 of bacterial contamination detected
with culture-based testing at expiration
2500
2000
2200
1500
1580
1000
500
1140
1200
900
662
0
PASSPORT
Wales
Corash, L. Expert Rev. Heme. 2011
German Irish BTS 4apheresis day retest
German
pools
Irish BTS
Confirmed cultures (per sample tested)
WBD vs. apheresis platelets
WBD
Study
Pool
size Method
N
Apheresis
Rate/
106
N
Rate/
106
OR
(95%CI)
5.8
Benjamin, US
5
PRP 20,725 965 431,490 167
Yomtovian, US
5
PRP 12,961 2,392 15,493
452
Schrezenmeier,
Germany
5
BC 22,044 726 15,198
855
NS
Murphy, Ireland
5
BC 30,407 329 12,823
312
NS
de Korte,
Netherlands
5
BC
6,749 1,322 4,963 2,418
Adapted from Benjamin et al. Transfusion. 2008
(3.5-9.5)
5.3
(2.3-12.0)
NS
Verax PGD®: 10 November 2009
Clinical vs. analytical sensitivity
Yomtovian et al. CID. 2008.
LOD for bacteria in platelets with Verax PGD®
Verax PGD PI. 2010.
Performance of Verax PGD® at ITxM
WBD platelet pools
Test
PGD
WBD
platelets Positive Positive
screened
tests
cultures
7733
14
2
Spec.
PPV
p
99.85 14.3
.014
pH
37060
405
4
98.93 1.0
After Yazer et al. AJCP. 2010
Verax PGD and apheresis platelets
(negative release culture at time of issue)
AP doses w/ valid
PGD
27,620
Repeat reactive
PGD
152
Negative PGD
27,469
.55%
Recultured
10,344
Culture positive
9
True pos PGD
Culture negative
142
False pos PGD
Culture positive
2
False neg PGD
Culture negative
10,342
True neg PGD
.033%
.514%
.019%
99.980%
Jacobs et al. Transfusion. 2011
Options to meet the intent of 5.1.5.1.1
• PGD® within 4 h. of transfusion on WBD pools: point of issue;
• Prepooled WBD platelets tested by supplier with approved
culture-based QC test;
• Culture aliquots from WBD units at pooling;
• Use methods not FDA-cleared but validated to be of
equivalent sensitivity to an approved assay, subject to review
at the time of accreditation assessments.
• Use apheresis platelets tested by supplier with approved
culture-based QC test;
• Should PGD (or equivalent) be used in transfusion service?
What else?
• pH, glucose and microscopy will NOT be acceptable
• Use of untested WBD pools (e.g. ≤3 days) will require
validation
• Use of Verax at ≤72 hr. may detect clinically important
bacteria, and should be considered when other
sensitive alternatives are not available
• Optimal practice is to test WBD pools before LR (per
PI); testing after LR may be considered if workflow or
clinical constraints demand
• Urgent platelet release without or during QC testing is
“practice of medicine” and is acceptable if addressed
in facility SOPs.
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