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Learning from screening
safety incidents
Nadia Permalloo, head of QA development (clinical), PHE
Methodology
• nine quarterly incident reports
• covering 1 October 2015 to 31 December 2017
• thematic analysis
2 Learning from screening safety incidents-IDPS lab workshop 11/03/19
Themes
3 Learning from screening safety incidents-IDPS lab workshop 11/03/19
Informed choice
• screening for infections where the woman has declined
Example: woman screened for HIV in error – she had declined screening
4 Learning from screening safety incidents-IDPS lab workshop 11/03/19
Insufficient/indeterminate samples
• screening sample taken and sent to the laboratory. The laboratory reported
onto the electronic system that the sample was insufficient and a further
sample was required for analysis. The sample was not repeated until
submitting KPI data 4 months later
• repeat sample required as initial screening sample was insufficient- this
request was not acted on in a timely manner. Lack of HIV result on tracking
list was not noted
• indeterminate HIV repeat request not undertaken for 11 weeks
5 Learning from screening safety incidents-IDPS lab workshop 11/03/19
Tracking / communication processes
• incomplete antenatal serology spreadsheet for a 2 week period - 4 women
had screen positive hepatitis B results during this time
• delay or failure in reporting positive screening result to screening team
6 Learning from screening safety incidents-IDPS lab workshop 11/03/19
Out of hours laboratory screening service
• women not previously booked for maternity care presenting in labour for the
first time
7 Learning from screening safety incidents-IDPS lab workshop 11/03/19
Using reference labs and transport
• delayed reporting of screening result. Initial screening sample sent to
reference laboratory. Delayed reporting by reference laboratory meant that
the final result was reported 2 months after the sampling
• two samples sent to reference laboratory were delayed. In both cases the
sample was not received and serum had to be resent
• screening samples lost in transit (>100 samples)
8 Learning from screening safety incidents-IDPS lab workshop 11/03/19
Communicating confirmed screening
results
• screening result reported as HIV screen positive before testing was
complete (screening result not confirmed)
• unconfirmed HIV positive result communicated to woman
• presumptive positive result communicated to woman before confirmatory
screening result (which was negative)
9 Learning from screening safety incidents-IDPS lab workshop 11/03/19
Checklist
1. How do we make sure we only test that are requested (informed choice)?
2. How do we makes sure all repeat requests (whatever the reason) are acted
upon in a timely manner?
3. How do we track samples- from request to sample to test to result including
those samples sent to a reference lab
4. How does everyone know how the out of hours lab screening service works?
5. How do we make sure we only communicate confirmed screening results to
maternity services? In cases where we have electronic reporting does
everyone understand what is recorded on the system?
10 Learning from screening safety incidents-IDPS lab workshop 11/03/19

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8. Nadia Permalloo learning from incidents

  • 1. Learning from screening safety incidents Nadia Permalloo, head of QA development (clinical), PHE
  • 2. Methodology • nine quarterly incident reports • covering 1 October 2015 to 31 December 2017 • thematic analysis 2 Learning from screening safety incidents-IDPS lab workshop 11/03/19
  • 3. Themes 3 Learning from screening safety incidents-IDPS lab workshop 11/03/19
  • 4. Informed choice • screening for infections where the woman has declined Example: woman screened for HIV in error – she had declined screening 4 Learning from screening safety incidents-IDPS lab workshop 11/03/19
  • 5. Insufficient/indeterminate samples • screening sample taken and sent to the laboratory. The laboratory reported onto the electronic system that the sample was insufficient and a further sample was required for analysis. The sample was not repeated until submitting KPI data 4 months later • repeat sample required as initial screening sample was insufficient- this request was not acted on in a timely manner. Lack of HIV result on tracking list was not noted • indeterminate HIV repeat request not undertaken for 11 weeks 5 Learning from screening safety incidents-IDPS lab workshop 11/03/19
  • 6. Tracking / communication processes • incomplete antenatal serology spreadsheet for a 2 week period - 4 women had screen positive hepatitis B results during this time • delay or failure in reporting positive screening result to screening team 6 Learning from screening safety incidents-IDPS lab workshop 11/03/19
  • 7. Out of hours laboratory screening service • women not previously booked for maternity care presenting in labour for the first time 7 Learning from screening safety incidents-IDPS lab workshop 11/03/19
  • 8. Using reference labs and transport • delayed reporting of screening result. Initial screening sample sent to reference laboratory. Delayed reporting by reference laboratory meant that the final result was reported 2 months after the sampling • two samples sent to reference laboratory were delayed. In both cases the sample was not received and serum had to be resent • screening samples lost in transit (>100 samples) 8 Learning from screening safety incidents-IDPS lab workshop 11/03/19
  • 9. Communicating confirmed screening results • screening result reported as HIV screen positive before testing was complete (screening result not confirmed) • unconfirmed HIV positive result communicated to woman • presumptive positive result communicated to woman before confirmatory screening result (which was negative) 9 Learning from screening safety incidents-IDPS lab workshop 11/03/19
  • 10. Checklist 1. How do we make sure we only test that are requested (informed choice)? 2. How do we makes sure all repeat requests (whatever the reason) are acted upon in a timely manner? 3. How do we track samples- from request to sample to test to result including those samples sent to a reference lab 4. How does everyone know how the out of hours lab screening service works? 5. How do we make sure we only communicate confirmed screening results to maternity services? In cases where we have electronic reporting does everyone understand what is recorded on the system? 10 Learning from screening safety incidents-IDPS lab workshop 11/03/19