Assuring the quality of cervical cytology laboratories

1. Assuring the quality of cervical cytology laboratories Dr Karin Denton Consultant cytopathologist Director of Quality Assurance

2. Cervical Screening Quality Assurance in the UK

3. Bristol

4. Is cervical screening in England working? • From 1988 – 1997 there was a 42% fall in incidence • In 1999 there were 2424 new cases • In 2002 there were 927 deaths • The NHS CSP saves an estimated 1300 lives and prevents 3900 cases/year

5. Regional National QA Director Screening program director Speciality Leads Cytology. Colposcopy, Recall National QA groups Speciality Groups Local working groups

6. Role of Quality Assurance groups • National groups set standards • Local groups • Monitor performance against standards • Support and co-ordinate remedial action • Propagate good practice

7. Setting quality standards for Cervical Cytology laboratories There are 2 types of standard • Process • Outcome

8. Process standards • Working environment • Staff • Cervical smear report • Laboratory protocols

9. Working environment • Concept is that staff will work better if comfortable • Evidence base ? • Ergonomic microscopes • Heat, light, security

10. Staff • Qualifications • Hours spent screening, productivity • Continuing professional development • Evidence base variable

11. Smear report • Standard nomenclature • Content of the report • Time to produce report • Who gets the report

12. Laboratory protocols • Technical (staining) • Internal and external quality assurance

13. External Quality Assurance(EQA) • Annual slide circulation • Complex protocol for identifying poor performance • Compared to peers • Also technical EQA comparing staining performance

14. Internal Quality Assurance • Based on rapid review of 100% slides • Differences in primary screening and final diagnosis recorded • Screeners must attain 90% sensitivity for all grades and 95% sensitivity for high grade • Protocol for action in the event of poor performance

15. Internal quality control by rapid review is most important way of monitoring quality • Depends on good Information Technology and standardised ways of calculating the figures

16. Laboratory Outcome measures • Reporting rates for abnormal and inadequate smears • Positive Predictive value (specificity)

20. 10th-90th centile 2001-2002 2002-2003 Inadequate 5.8 – 12.7 6.1 – 12.6 Mild Dyskaryosis and Borderline change 4.3 – 8.9 4.0 – 9.1 Moderate dyskaryosis and worse 0.9 – 1.7 0.9 – 1.7 Positive Predictive Value 68% - 86% 65% - 88%

21. How do we monitor process and outcome • Questionaires • Laboratory Quality Assurance visits

22. Quality Assurance Visits • 3 yearly cycle • Visit is multidisciplinary • No National protocol as yet • Inspection of laboratory, interviews with staff

23. Making Quality Assurance work • Authority • Usually staff are well aware of shortcomings • Improvements usually require increased spending • Owning institutions must respect the authority of the Quality Assurance Team

24. Openness • All outcome data is published nationally • Detailed process and outcome data published within professional groups

25. Where can you find out more? • www.cancerscreening.nhs.uk • All published quality guidelines • Links to National statistical bulletin • Reports on progress of the NHS Cervical screening program • New developments including Liquid Based Cytology and HPV testing