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Scope of this report
| Covered by this report? | If ‘no’, where you can find information about this part of the pathway | |
|---|---|---|
| Underpinning functions | ||
|
Uptake and coverage |
No |
NHS England – Greater Manchester Public Health Commissioning team |
|
Workforce |
Yes |
Not applicable |
|
IT and equipment |
Yes |
Not applicable |
|
Commissioning |
Partly |
NHS England – Greater Manchester Public Health Commissioning team |
|
Leadership and governance |
Yes |
Not applicable |
| Pathway | ||
|
Cohort identification |
No |
Cervical Screening Administration Service |
|
Invitation and information |
No |
Cervical Screening Administration Service |
|
Testing and results |
No |
Report for Manchester University NHS Foundation Trust QA visit on 20 March 2023 |
|
Referral |
Yes |
Not applicable |
|
Diagnosis |
No |
Report for Northern Care Alliance NHS Foundation Trust QA visit on 7 July 2022 |
Intervention/treatment |
Yes |
Not applicable |
Summary
The NHS Cervical Screening Programme invites women between the ages of 25 and 64 for regular cervical screening. This aims to detect abnormalities within the cervix that could, if undetected and untreated, develop into cervical cancer.
The findings in this report relate to the quality assurance visit on 19 March 2024 to Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust Cervical Screening Service which is commissioned by NHS England – Greater Manchester Public Health Commissioning team. Any commissioning findings are outside the scope of this report and will be followed up directly with the commissioner.
Quality assurance purpose and approach
Quality assurance (QA) aims to achieve and maintain national standards, promote continuous improvement in cervical screening and support reducing health inequalities. This is to ensure that all eligible people have access to a consistent, high quality, effective, equitable and safe service wherever they live.
QA visits are carried out by the NHS England Screening Quality Assurance Service (SQAS).
The evidence for this report comes from the following sources:
- monitoring of routine data collected by the NHS England
- data and reports from external organisations
- evidence submitted by the provider and external organisations
- discussion with commissioner in advance of the visit
- information collected during pre-review visits to Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust on 6 March 2024
- information collected during observation of colposcopy multidisciplinary team meeting on 28 February 2024
- information shared with the North regional SQAS as part of the visit process
The screening service
The Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust (WWL) provides colposcopy services as part of the NHS Cervical Screening Programme for the population of Wigan Borough. The colposcopy service also sees individuals referred from the West Lancashire area. The colposcopy service is provided at Leigh Infirmary.
The cervical biopsies taken at the WWL colposcopy service are sent to Northern Care Alliance NHS Foundation Trust histopathology service for processing and reporting.
Findings
The last QA visit to Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust colposcopy service was on 6 June 2017. All recommendations from the visit have been completed. SQAS conducted a QA review of colposcopy data on 10 May 2022. There is one recommendation open from this review. This relates to the reliability of data for mandatory colposcopy data returns. The QA visit team found that further data validation is required to make sure future data returns are accurate.
The service is led by a consultant gynaecologist, who is the Cervical Screening Provider Lead (CSPL) and Lead Colposcopist. The CSPL has routes to escalate issues and risks but the documented organisational and accountability structures for the colposcopy service lack clarity. There are process gaps in the service’s invasive cervical cancer audit and there is a large backlog of incomplete audits.
The colposcopy service implemented a new IT system at the beginning of 2023. Due to the quality of historic data transferred into the new IT system, some of the data submitted by the service in the NHS Cervical Screening Programme annual colposcopy data returns may be unreliable.
Colposcopy capacity is closely monitored by the service and the service consistently achieves waiting time standards for NHS Cervical Screening Programme referrals.
Immediate concerns
The QA visit team identified no immediate concerns.
Urgent recommendations
The QA visit team identified four urgent recommendations. A letter was sent to the Cervical Screening Provider Lead (CSPL) on 20 March 2024 asking that the following items were addressed:
- validate the data for the proportion of treated individuals with cervical intraepithelial neoplasia (CIN) or cancer within 12 months of colposcopy procedure (histological treatment failures) and clinically review the cases to identify themes for quality improvement of the patient pathway
- take action to reduce the proportion of large loop excision of the transformation zone (LLETZ) treatment samples that are removed in more than one piece
- provide evidence that there are documented guidelines for the management of a gynaecological emergency in colposcopy, including urgent transfer to an acute site
- ensure that there is adequate capacity, including administration support, to address the backlog of invasive cervical cancer audit cases
A response, including an action plan, was received informing the visiting QA team of the steps taken to partially resolve the urgent recommendations. The QA team has requested the CSPL provide further information on the actions that will be taken to make sure there is adequate capacity to address the backlog of invasive cervical cancer audit cases.
High priority findings
The QA visit team identified five high priority findings as summarised below:
- operational meeting arrangements do not meet the NHS Cervical Screening Programme requirements
- process gaps for the completion of the invasive cervical cancer audit and a large backlog of incomplete audits
- invasive cervical cancer audit disclosure process not fully implemented
- no clinical guidelines for conservative management of high grade cell changes (cervical intraepithelial neoplasia (CIN) 2)
- case selection criteria for the colposcopy multidisciplinary meeting are out of date.
Recommendations
The following recommendations are for the provider to action unless otherwise stated.
| No. | Recommendation | Pathway theme | Reference | Timescale | Priority | Evidence required |
| Urgent recommendations | ||||||
|
01 |
Validate the data for the proportion of treated individuals with cervical intraepithelial neoplasia (CIN) or cancer within 12 months of colposcopy procedure (histological treatment failures) and clinically review the cases to identify themes for quality improvement of the patient pathway |
Intervention and outcome – colposcopy |
5 |
14 days |
Urgent |
Review findings and action plan |
|
02 |
Take action to reduce the proportion of large loop excision of the transformation zone (LLETZ) treatment samples that are removed in more than one piece |
Intervention and outcome – colposcopy |
5 |
14 days |
Urgent |
Action plan |
|
03 |
Provide evidence that there are documented guidelines for the management of a gynaecological emergency in colposcopy, including urgent transfer to an acute site |
Intervention and outcome – colposcopy |
1 |
14 days |
Urgent |
Standard operating procedure |
|
04 |
Ensure that there is adequate capacity, including administration support, to address the backlog of invasive cervical cancer audit cases |
Governance and leadership |
1, 2, 3 |
14 days |
Urgent |
Action plan and confirmation of administration support |
|
No. |
Recommendation |
Reference |
Timescale |
Priority |
Evidence required |
| Service provider and population – no recommendations made | |||||
| Governance and leadership | |||||
|
05 |
Update the job description for the Cervical Screening Provider Lead |
2 |
3 months |
Standard |
Job description |
|
06 |
Revise quarterly operational meeting arrangements to meet NHS Cervical Screening Programme guidance on agenda content and membership |
2 |
6 months |
High |
Terms of reference, meeting schedule |
|
07 |
Establish a protocol for the completion of the invasive cervical cancer audit and ensure the national invasive cancer audit data collection is up to date |
3 |
6 months |
High |
Protocol, completion of cases diagnosed between 01/2020 and 12/2023 |
|
08 |
Update the policy for the offer of disclosure of invasive cervical cancer audit and complete an audit to demonstrate offer of disclosure |
4 |
12 months |
High |
Policy and audit |
|
09 |
Document the process for results and referral for cervical samples taken in the trust outside of colposcopy and conduct a failsafe audit of the cervical samples taken in gynaecology |
1 |
6 months |
Standard |
Ratified process and audit findings |
|
10 |
Update the organisational structure and demonstrate how programme performance issues and risks are escalated and managed within the trust governance system |
1 |
3 months |
Standard |
Organisational structure and documents outlining accountability arrangements |
|
11 |
Update the local colposcopy incident policy to make sure that contact details for the notification of incidents are correct |
7 |
6 months |
Standard |
Standard operating procedure |
|
12 |
Update the job description for the Lead Colposcopist |
1, 5 |
3 months |
Standard |
Job description |
|
13 |
Implement a standard operating procedure for the production, validation, and discussion of KC65 and annual colposcopy data |
1, 5 |
6 months |
Standard |
Standard operating procedure and evidence of data validation by Lead Colposcopist |
|
14 |
Make sure the Lead Nurse for Colposcopy has a job description and dedicated time for the role
|
1 |
3 months |
Standard |
Job description and confirmation of time allocation for role |
| Referral – no recommendations made | |||||
| Intervention and outcome – colposcopy | |||||
|
15 |
Make sure that the appropriate governance and training requirements are in place for the use of Entonox in colposcopy |
1 |
3 months |
Standard |
Protocol |
|
16 |
Update the local colposcopy clinical guidelines to reflect current NHS Cervical Screening Programme guidance, including detail on supporting individuals from underserved and protected groups and conservative management of CIN 2 |
1, 5 |
6 months |
High |
Ratified guidelines |
|
17 |
Put in place a colposcopy induction protocol for new staff and locums |
1 |
6 months |
Standard |
Protocol |
|
18 |
Put in place a protocol for the use of diathermy |
1 |
3 months |
Standard |
Protocol |
|
19 |
Update the nursing standard operating procedure to document the clinic preparation requirements |
1 |
6 months |
Standard |
Standard operating procedure |
|
20 |
Make sure there is a protocol for safe transport of screening specimens to the cytology and histopathology laboratories |
1 |
6 months |
Standard |
Protocol |
|
21 |
Update colposcopy administration standard operating procedures including detail on results, failsafe and individuals treated under general anaesthetic |
1, 5 |
6 months |
Standard |
Standard operating procedures |
|
22 |
Make sure clinical indication referrals are accurately recorded in the KC65 data |
1 |
3 months |
Standard |
Validated KC65 data return |
|
23 |
Update patient letters and leaflets to reflect NHS Cervical Screening Programme colposcopy outpatient treatment advice and to offer reasonable adjustments and accessible information |
1, 5 |
6 months |
Standard |
Copies of appointment letter and information leaflet |
|
24 |
Complete an annual user survey of colposcopy services |
1 |
12 months |
Standard |
Outcome of survey and evidence of review of results |
Multidisciplinary team | |||||
|
25 |
Update multidisciplinary team meeting standard operating procedure, ensuring case selection criteria reflects NHS Cervical Screening Programme guidance |
5 |
3 months |
High |
Standard operating procedure |
|
26 |
Complete the audit of cases discussed outside of the multidisciplinary team (MDT) meeting and take action to ensure that all relevant cases are discussed at the colposcopy MDT |
5 |
6 months |
Standard |
Audit findings and action plan |
|
27 |
Streamline the cases listed on the multidisciplinary team meeting to ensure there is capacity for full discussion of cases meeting the NHS Cervical Screening Programme case selection criteria |
5 |
3 months |
Standard |
Action plan |
|
28 |
Make sure documented multidisciplinary team meeting outcomes are shared with cytology and histopathology to enable recording on relevant systems |
5 |
3 months |
Standard |
Standard operating procedure |
Next steps
The screening service provider is responsible for developing an action plan in collaboration with the commissioners to complete the recommendations contained within this report.
SQAS will work with commissioners to monitor activity and progress of the recommendations for 12 months after the report is published. After this point SQAS will send a letter to the provider and commissioners summarising the progress made and will outline any further action(s) needed.
Appendix A: references
1. NHS England. NHS Public Health Functions Agreement: 2023/24 Service Specification No.25 Cervical Screening
2. NHS Cervical Screening Programme. Cervical screening: role of the cervical screening provider lead; 2018
3. NHS Cervical Screening Programme. Cervical screening: auditing procedures; 2021
4. NHS Cervical Screening Programme. Cervical screening: disclosure of audit results toolkit; 2021
5. NHS Cervical Screening Programme. Cervical screening: programme and colposcopy management; 2023
6. NHS Cervical Screening Programme. Cervical screening: cytology reporting failsafe (primary HPV); 2019.
7. NHS England. Managing safety incidents in NHS screening programmes; 2023
8. NHS England. Quarterly Cervical Coverage Report; March 2023
9. Office for National Statistics. How life has changed in Wigan: Census 2021; 2023