Screening quality assurance visit report – Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

NHS Cervical Screening Programme
19 March 2024

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.RecommendationPathway themeReferenceTimescalePriorityEvidence 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

Referralno 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