Management of the Outcome of Bacterial Monitoring Investigations
1.0
Introduction
All UK Blood Services carry out routine bacterial screening on all platelet
components. Where an initial positive is identified, all related components will
be quarantined and/or recalled very rapidly (with a target for this to be
initiated within 1 hour of the identification of the initial reactive result). In this
way, appropriate action is taken to reduce the risk to patients. However, on
occasions, a component will be transfused before a positive result has been
detected. All such events will require some degree of investigation. This
paper is intended to define the agreed basis on which such investigations will
be carried out. The extent and complexity of follow-up investigations will
depend on the level of risk, so that a full investigation will not be required on
each occasion, but a minimum documented investigation/statement is
required for all initial reactive results from platelet screening regardless of
whether they have been transfused or not.
In addition to defining the extent of the investigation to be undertaken, the
paper will also define those circumstances where a report needs to be made
to SABRE.
2.0
Definition of BacTALERT Results
Where an initial reaction is identified, there are 4 possible outcomes, as
follows
2.1
Confirmed Positive
A positive result will be confirmed if bacteria are grown from the initial reactive
bottle and bacteria of the same species are detected in either the index bottle
or an associated blood component.
2.2
Indeterminate Positive
An indeterminate result will be recorded if bacteria are grown from the initial
reactive bottle, but no material is available to carry out a repeat test and/or
the component(s) has been transfused
Or
Bacteria are detected in the initial screen but not the repeat screen
Or
Bacteria are detected in the initial screen or repeat test which cannot be
matched at the species level
2.3
Indeterminate Negative
An unconfirmed result will be recorded when nothing is grown from the bottle
but there is no index or associated pack to retest
2.4
False Positive
A false positive result will be recorded where no bacteria are found in the
original culture bottle and there is no growth in the index or associated
component packs.
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Management of the Outcome of Bacterial Monitoring Investigations
3.0
Reporting to SABRE
Following an initial positive result, the decision tree for reporting to SABRE is
in the attached flow diagram (appendix 1). In essence, a report to SABRE will
be required in the following circumstances
3.1
Failure of the QMS
Any failure of the QMS will be reported. Such failures could include the
following:
•
Failure to initiate recall/quarantine of components within a reasonable
time frame
Recall process
1) Ensure Recall is initiated and conducted as required.
Report to SABRE if the following timeframes are exceeded (unless
exceptional circumstances prevail):
- From “Initial Reactive” result to confirmation that component has
been successfully quarantined > 4 hours
- From contact made with hospital to unit removal from supply chain
> 1 hour
2) Confirm Hospital response – Unit Quarantined /Disposed of
/Transfused.
3) For components reported as transfused confirm that the transfusion
time was prior to the time the hospital was contacted
•
•
•
•
Failure of recall process to prevent transfusion of implicated component
Failure to carry out arm cleansing or donor selection activity effectively
Failure to clean processing equipment to the required standard
Any other serious failure in the collection, processing, testing, storage or
distribution of the component
If a QMS error is detected as a part of any investigation, then this will be
reported to SABRE as a Serious Adverse Event. The Root Cause Analysis
and Corrective Action / Preventative Action will be reported as appropriate in
the confirmation report.
3.2
Administration of Confirmed or Indeterminate Positive Components to a
Patient
Such incidents will be investigated as detailed in Section 4
4.0
Standardised investigation pathway following an initial reactive result
from platelet screening and the subsequent requirements for reporting
to SABRE
4.1
Initial Actions
Following an initial reactive on a BacT/ALERT test
1) Quarantine on-site components (red cells, platelets, plasma, etc.)
2) Recall off-site components / materials
3) Manage through the QMS either through the recall process or by raising
an incident
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Management of the Outcome of Bacterial Monitoring Investigations
4) Culture of a sample taken from the reactive BacT/Alert bottle
5) Retest initial sample or associated component if available
6) Advise hospital clinicians of event if component has been transfused
The cultured sample may or may not result in growth. Initial follow up will be as
follows
No Growth
Investigate the apparent “false positive”
1) Check the incident management system or recall system to
ensure that there is not an increased trend in these events. (No
reported events may be considered as confirmation that all
current procedures have been followed as required).
2) Have a procedure in place that ensures the culture growth media
is capable of supporting growth (for example positive control,
certified materials within shelf life).
3) Have a procedure in place that ensures all equipment (incubators,
safety cabinets, etc.) is performing as required and within
calibration dates.
4) Ensure that procedures include a review of the growth curve from
BacT`/ALERT to consider the positivity index where false
positives will have an index <1. Advice may be taken from the
local microbiology laboratory
Growth
4.2
Proceed with culture of a second sample from the original unit (if
available).
Follow up of False Positive or Unconfirmed Positives
No further investigation will be carried out if the initial positive result has been
discounted for either of these reasons.
4.3
Follow up of Confirmed or Indeterminate Positives
For all confirmed positives and indeterminate positives an investigation
will be carried out. Each of these incidents will be managed as a quality
incident.
The types of additonal investigation have been categorised based on the
current knowledge of the clinical relevance of the findings of bacterial
screening; this ensures that investigations appropriate and relevant to the
implicated organism are completed.
4.3.1
Organisms not likely to be blood borne
If it is not likely that the organism was blood borne e.g. Propionibacterium
acnes, then it is possible that there has been a failure in the collection
process. The likely source may be the skin of the donor or an environmental
source. Confirm with relevant Blood Donation staff that they consider the arm
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Management of the Outcome of Bacterial Monitoring Investigations
disinfection process is satisfactory for the venepuncturist concerned. Confirm
with the managers involved that they consider the environmental monitoring
was satisfactory. No other action is required unless these investigations
indicate a problem.
Collection
1)
2)
3)
4)
5)
Miscellaneous
Check the incident management system to ensure that no
relevant incidents have been reported.
(No reported
incidents may be considered as confirmation that all current
procedures have been followed as required).
Venepuncturists (may be up to 4 venepuncturists to be
checked for Buffy coat pooled platelets)
- Check the last 12 month arm cleansing history. If any
failures have been identified ensure that any remedial
actions have been addressed.
- Ensure all training is current
Check complaints system / session notes to see if any
donors have reported incorrect arm cleansing.
Static site only – Check environmental monitoring results
for past 3 months – confirm no apparent trends.
Check that all equipment is performing as required and is
within calibration dates.
Any additional aspects that the Establishment wish to review e.g.
donor history.
4.3.2 Organisms likely to be blood borne
These organisms e.g. Staphylococcus aureus, E. coli may have the potential
to cause harm in a recipient. Investigate the donor to build up an evidence
base, confirm relevant environmental and arm disinfection procedures and
donor selection procedures operated effectively.
Collection
1)
2)
3)
4)
Processing
1)
2)
Check the incident management system to ensure that no
relevant incidents have been reported.
(No reported
incidents may be considered as confirmation that all current
procedures have been followed as required).
Venepuncturists (may be up to 4 venepuncturists to be
checked for Buffy coat pooled platelets)
- Check the last 12 month Arm Cleansing history. If any
failures have been identified ensure that any remedial
actions have been addressed.
- Ensure all training is current
Check Complaints system / session notes to see if any
Donors have reported incorrect arm cleansing.
Check that all equipment is performing as required and is
within calibration dates.
Check the incident management system to ensure that no
relevant incidents have been reported. (No reported
incidents may be considered as confirmation that all current
procedures have been followed as required).
Confirm cleaning has been regularly undertaken in
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Management of the Outcome of Bacterial Monitoring Investigations
3)
4)
Storage
1)
2)
3)
Miscellaneous
appropriate areas
Check environmental monitoring results and monitoring of
sterile connecting devices for past 3 months – confirm no
apparent trends.
All equipment performing as required and within calibration
dates.
Check the incident management system to ensure that no
relevant incidents have been reported. (No reported
incidents may be considered as confirmation that all current
procedures have been followed as required).
Confirm cleaning has been regularly undertaken in
appropriate areas
Confirm
- Time from collection to required storage conditions (i.e.
20°C to 24°C) to be three hours or less.
Any additional aspects that the Establishment wish to review e.g.
Donor history.
If the organism is deemed to be clinically relevant, then further follow up of the donor
will also be necessary. In these cases experts in microbiology or health protection will
be able to provide advice as to their potential source. They will coordinate actions
concerning the donor with any relevant public health follow-up. The investigation will
be managed through a Quality Incident. It will investigate donor, donor history,
environment and processes. The team involved will identify appropriate action based
on the bacterial species involved and the current understanding of the potential
routes of transmission.
Conclusion
The UK regulatory group proposes that
•
The level of investigation that will be undertaken is driven by risk to patients,
irrespective of whether the component has been transfused.
•
Organisms which are likely to be blood borne will be investigated whether the
components have been issued or not. A root cause of the contamination will be
sought so effective preventative action can be implemented. Where the cause is
a systematic failing which needs to be corrected they will be reported to SABRE.
•
Organisms which are unlikely to be blood borne will prompt investigation of the
collection process only. This is because of the experience the UK blood services
have gained since screening was first implemented in Wales in 2003. NHSBT
has investigated the source of contamination of confirmed and indeterminate
positives which have been transfused before a recall on the basis of bacterial
screening activity could be completed. Of over 80 investigations completed so far
NHSBT has not demonstrated any systematic failures within the quality
management system procedures for arm disinfection, environmental cleaning,
sterile connecting, environmental monitoring or recall. The majority of
investigations could not determine a cause and they have mainly been presumed
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Management of the Outcome of Bacterial Monitoring Investigations
to be transient skin contaminants which may not be removed by Chloroprep as
they are found deep within the skin. A small number of investigations identified
the source of contamination as normal microflora of either the donors arm or
oropharynx. None of these contaminants have been identified as a cause of a
transfusion reaction in a recipient. The pattern of identified organisms in the
transfused group to the non transfused group is similar. The conclusion is that
this confirms that UK BTS systems to reduce the risk of bacterial contamination
are effective.
•
A SABRE report will be submitted when a failure in the collection, processing,
storage or distribution processes leading to contamination cannot be discounted
(positive or indeterminate test results)
The approach allows UK services to focus investigations on a group of events
which have the capability to highlight systematic failings in our systems but which
are unlikely to impact significantly on patients. If these investigations were to
identify Quality Management System failings then either individual events or a
series of them would be reported to SABRE. This approach will ensure that all
bacterial reactives will be investigated appropriately.
As agreed by the Blood Consultative Committee
(including members of the UK Regulatory Group)
April 2013
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Management of the Outcome of Bacterial Monitoring Investigations
Appendix 1
Flow Chart for Following Up BactALERT Positives
Initial screen
positive
Staff quarantine platelet and associated components and/or
initiate recall
If recall or quarantine
fails, incident report and
submit SABRE report
Indeterminate
(No retest sample available)
Sample and/or
component retested
Positive result and/or QMS failure
Contamination
discounted
Investigate further, risk
assess and submit
SABRE report if appropriate
SABRE report not required,
no further investigation
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Management of the Outcome of Bacterial Monitoring Investigations
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