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					CERVICAL CYTOLOGY ISSUE                                                                                   ITEM AOB
                                Decision            Discussion            Information

IMPACT ON STRATEGIC DIRECTION: None


FINANCIAL IMPACT: None


IMPACT UPON SERVICE USERS: Results of Cervical Cytology samples for some women in
Hillingdon have been delayed. It is unlikely that there will detriment to the health of the women
concerned as a result of this.


IMPACT UPON STAFF: None


IMPACT UPON INTERNAL PARTNERS: None


IMPACT UPON EXTERNAL PARTNERS: None


IMPACT UPON EQUITY: None


IMPACT UPON PCT OBJECTIVES:


PCT Objectives:
1. To improve access to health and healthcare                    5. To develop partnership working
2. To develop new and innovative ways of delivering services     6. To build an organisation that is learning and developing
   and alternative models of care, particularly for those with   7. To deliver within existing resources, ensuring best
   long term conditions                                             value at all times
3. To improve the user experience and develop the capacity of    8. To deliver national programmes to enable change
   patients, carers and the wider public to be involved in the   9. To achieve compliance with the core Healthcare Standards
   delivery of healthcare and managing their own health
4. To improve the health of the population through identifying
   unmet health need, reducing inequality and influencing the
   wider determinants of health


ANY OTHER CRITICAL INFORMATION:




             Hillingdon Primary Care Trust Board Meeting (PART ONE – PUBLIC MEETING)
Date of meeting: 15th August 2006                                                                      Page No 1
CERVICAL CYTOLOGY ISSUE                                                        ITEM AOB
                                                                   Contact Name: Terry Kelly
                                                                 Contact Tel No: 01895 452076


SUMMARY

This report describes a recent problem with transmission of cervical cytology results to 1346
Hillingdon women, the process of investigation of the incident, actions taken and outcomes.

RECOMMENDATIONS

Board is requested to:

1. Note this report and the outcomes of the investigation into the issue

TERMS/ACRONYMS USED IN THE REPORT

LBC           Liquid Based Cytology
QARC          Quality Assurance Reference Centre (a department of the National Cancer
              Screening Programme)
NHSCfH        NHS Connecting for Health
CY screen     Cytology screen. The screen which contains all Cytology results

INFORMATION

Background

Women are invited to undertake a cervical screening test on a 3 or 5 year cycle dependant on
age. Samples are taken mainly in GP surgeries and/ or in Family Planning clinics and women
are informed of the result by letter. Where results are ‘normal’ the women go back on the 3/5
year cycle. Where results are ‘inadequate’ women are invited back for a further sample within 3
months and where results show abnormalities women are recalled within 6 or 12 months
depending on the nature of the abnormality. In all cases the PCT sends results letters out and
women with ‘inadequate’ or abnormal’ results are also contacted by the sample taker, who is
notified of results direct from the laboratory. Up to 19,000 samples are taken each year in
Hillingdon.

From April 2006 the PCT introduced Liquid Based Cytology, a new technology approved by
NICE, which makes screening of samples more efficient and reduces the potential for
‘inadequate’ results requiring a further test. In introducing LBC the PCT re-commissioned
laboratory services, moving these from West Herts to North West London NHS Trust.

Description of issue
Between 24th March and 19th April 2006 the system used to transfer results to the PCT and
generate letters was placed in ‘training mode’. This was to enable the PCT to check 100% of
results coming from North West London NHS Trust to ensure the data was correct following the
change of provider. The NHSCfH informed the PCT that no electronic data would be updated
during this period. It was not made clear that this would include files transferred from West
Herts by e-mail. Subsequently, six files, involving1,346 results of samples taken before 1st April
and processed under the old agreement with West Herts were not updated and result letters
were not sent out.



          Hillingdon Primary Care Trust Board Meeting (PART ONE – PUBLIC MEETING)
Date of meeting: 15th August 2006                                                Page No 2
The PCT became aware of this on 12th July 2006 following a telephone call from a patient
enquiring about her result.

On investigation it was found that of the 1346 results that were not updated, 1,055 were normal,
193 were inadequate and 98 showed abnormalities.

Actions taken

Following initial investigation to ascertain there was indeed a problem the PCT contacted the
National Screening Programme Quality Assurance Reference Centre on 14th July, for advice
and was advised to log this issue as and ‘Early Warning’ rather than an SUI. A formal
investigation group was formed.

   -   Standard results letters were sent to women with normal results, with no further
       communication (20th July)
   -   Standard letters were sent to women with inadequate results, with a covering letter
       explaining the problem, apologizing for the delay in letting them know of their result and
       providing contact details if the wished to discuss the matter further(19th July)
   -   All sample takers for those women with abnormal results were contacted to ensure they
       had contacted the women involved. Three women had not been contacted and the GP
       practices agreed to follow this up. The PCT has asked for copies of letters from the
       smear taker sent to women with abnormal results, as confirmation of contact.
   -   NHSCfH were contacted to ensure the issue was not a system error and to alert them to
       the need to ensure all PCTs are aware of the potential problem whilst the system is in
       ‘training mode’ as they switch to LBC.
   -   The PCT has instigated random checks on the results transferred to the CY screen for
       automatic hits and manual matches
   -   The PCT is exploring the feasibility of auditing the number of letters produced against
       expected numbers
   -   A formal investigation group was convened to review the issue and actions taken and to
       identify further actions required.
   -   A report on the issue has been sent to QARC as required by national screening
       guidance
   -   A case study is being prepared between the PCT and QARC to share the problem with
       national screening networks and as an exemplar as to how to handle this situation
       should it happen elsewhere.

Outcomes

   1. None of the women with abnormal results have missed their next test due date.
   2. Because of the actions taken and the timely manner in which they were taken, by the
      PCT to investigate and resolve the situation and because there is little likelihood that
      any of the women involved suffered health detriment the initial impression from the
      QARC representative on the investigation group is that this matter will remain at the
      level of Early Warning and can now be classified as closed. We are still awaiting formal
      confirmation of this view.

APPENDICIES
None

BACKGROUND DOCUMENTS
Report to QARC on Investigation of Hillingdon Cervical Cytology Incident and actions taken to
resolve it.



          Hillingdon Primary Care Trust Board Meeting (PART ONE – PUBLIC MEETING)
Date of meeting: 15th August 2006                                               Page No 3

				
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