This document discusses quality standards for colposcopy. It proposes that the European Federation for Colposcopy (EFC) approve national quality assurance concepts for colposcopy. This would include evaluating colposcopists' case loads and performance on key quality indicators. The document also reviews different quality indicators for colposcopy, such as rates of clear margins after treatment and detection of high-grade lesions. It suggests these indicators could be improved and should allow flexibility for national standards. Overall it argues continuous quality assurance of colposcopy education, training and practice is needed, and this can be delivered across different healthcare settings with EFC harmonization.

2. Performance standards-
how to assess the quality of
colposcopy in
daily practice?
K. Ulrich Petry, Germany

3. Summary on
screening
Conclusions
• 1.1 Primary HPV-Screening for
women (30) 35+ years (I-A)
• 1.2 Avoidance of co-testing (HPV
plus cytology) (II–A)
• 1.4 No HPV-Screening below age
30 years (I–E)
• 1.8 The screening interval after a
negative HPV-test should be at least
5 years (I-A)
• 1.15 Direct referral to colposcopy of
all HPV positive women is not
recommended (I-D)
036
WHO / IARC / EC 2015

4. 1
29
2
3
4
5
6
78
9 10
13
16
17
19
20
12
11
21
Screening for cervical cancer in Europe 2018
Pap screening (reimbursed)
Nationwide HPV screening
Organised HPV screening
in progress
„Wild“ Pap screening
Regional HPV screening
Organised Recall Pap Screening
Political decision for organised
HPV Screening

5. Organised Screening with call and recall
20-30 yrs > 30 yrs
Pap
3 years
HPV
5 years
Triage
(HPV, Biomarker)
Triage
(HPV, Biomarker)
Colposcopy
Non-Responder
HPV-Self-testing
Petry 2016
Level of evidence IA
Level of evidence IA-IIB
?

6. How good is colposcopy as „gold
standard“ ?
o Screening-Colposcopy showed poor sensitivity and
specificity Schneider A, IJC 2000
o HPV-Vaccine trials showed poor sensitivity of
colposcopy impression for CIN3+ Stoler M, IJC 2011
o Randomized controlled studies showed that a
standardized colposcopy protocol detected as many
CIN3+ as immediate LEEP TOMBOLA, BMJ 2010
o Sensitivity of colposcopy guided biopsies for CIN3
ranged from 29-93% in a US trial Pretorius R, JLGTD 2011
o The failure rate of colposcopy (missed CIN3+) is
significantly increased in women with positive HPV
tests but normal cytology Petry KU, GynOncol 2013
We need to assure quality of
colposcopy

7. Standardized colposcopy is safe –
colposcopy without standards may be harmful
Standard Detected
CIN3+ at
1st colpo
Missed
CIN3+ in
5 yrs FU
Failure rate
(missed CIN3+
of all CIN3+)
Punch biopsies of any lesion (minor and
major changes) in type 1 or 2 TZ
97 3 3%
ECC in all type 3 TZ 13 5 27.8%
Excisional treatment in HSIL+ and HPV+ 19 0 0
Excisional treatment in CIN2+ and
type 3 TZ
7 0 0
Excisional treatment in major
changes/HPV+/type 3 TZ
4 0 0
N= 667 women tranferred because of abnormal screening results, 171 CIN3+
Petry KU et al. , Gyn Oncol 2013
66 34 34%

8. Standardized histological assessment
improves the sensitivity of colposcopy
• Taking 3 biopsies increased sensitivity for
CIN3+ to 95.6%
• Only 2% of HSIL were detected by random
biopsies from colposcopically normal tissue
N. Wentzensen et al , JCO 2015

9. EFC approval of national QA concepts in practice of
colposcopy (“expert colposcopist”)
National societies submit their concepts / QA-programs to
the EFC executive board. The submission must include :
1. A well defined independent evaluation of the overall
case load, as well as numbers of low-grade and high-
grade disease seen by individual colposcopists per year
2. Evaluation of the individual performance with the use
of the 4 EFC quality indicators
EFC approval 1. = Colposcopist fulfilling EFC standards
1.+2. = and member of EFC´s QA program
Original slide from the EFC-GA consensus in Prague 2013

10. Phase 2
EFC Quality indicators for colposcopy
E. Moss et al.: European Federation for Colposcopy quality standards Delphi consultation.
Eur.J.Obstet.Gynecol.Reprod.Biol. 2013: 170:255

11. 3 steps to certify a reliable quality in colposcopy
Numbers
• Competition between different
concepts of national societies to
control case loads of individual
colposcopists
Quality
parameters
• Competition of concepts to assess
and optimize the EFC quality
indicators
Standardized
reliable QA
•Based on redefined
caseload and
redefined quality
indicators
2014-2016
2014-
2019
Rome 2019

12. • Use the quality parameters to assess quality in colposcopy.
• Use the quality assessment to evaluate the quality parameters

14. Independent electronic bench-marking
02.05.2009 14(c) asthenis GmbH
Data collected were automatically anonymized, encrypted and stored in a secure relational
database located within the clinics’ network

15. Prospective evaluation of QA standards 06.09.2013 | 15
Percentage of excised lesions/conizations with clear margins
0
10
20
30
40
50
60
70
80
90
100
1 2 3 4 5 6 7 total
%
EFC
target
Results

16. Figure 6. Histogram representing the distribution of the proportion of positive margins in
women treated for high-grade CIN observed in eligible studies. The red line (20%) represents
the maximum positivity considered by EFC as the benchmark of good quality.
Risk of treatment failure associated with positive section margins of excisional
treatment for high-grade CIN: a systematic review and meta-analysis.
Marc Arbyn 2014 review for EFC
“The margin status has poor sensitivity to predict treatment
outcome. hrHPV is approximately 50% more sensitive and not less
specific compared to the margin status.”
The importance of margin involvement to assess the risk of post-
treatment disease is controversial, especially since a direct link
between the size of the excisional specimen and obstetrical
outcomes has been shown
The majority of colposcopists do not reach the EFC benchmark of
>80% clear margins. A revision of this benchmark (>70%) should
be considered.

17. N= 10.869 Luyten A, EJOGRB 2015

18. Conclusions
• Electronic data collection is easy and does not
relie on specific software
• Independant electronic Q/A (benchmarking)
needs special software and support but is feasible
• EFC QI can be used for benchmarking but will
need a revision
• 100% target should not be used in Quality
Assessment
• Clear margins > 80% should be replaced
Luyten A, EJOGRB 2015

19. Berlin Consensus 2011
QA of each part of the colposcopy service
1. Quality of colposcopic examination /
identification of SCJ
2. Colposcopical guidance of excisional CIN
therapy
3. Quality of indication/selection for excisional
therapy
4. Proof of cure following invasive treatment
of CIN
5. Experience

20. EFC Quality indicators
2015 EFC satellite meeting - Consensus revisions
Parameter Aim
For cervical colposcopy TZ type (1,2 or 3) should be
documented (100%). 100%
Percentage of cases having a colposcopic examination prior
to treatment for abnormal cervical screening test 100%
Percentage of excisional treatments/conizations have a
definitive histology of CIN2+. Definitive histology is highest
grade from any diagnostic or therapeutic biopsies >85%
Percentage of excised lesions/conizations with clear margins >80%
Number of colposcopies personally performed each year for a low-
grade/minor abnormality on cervical screening >50
Number of colposcopies personally performed each year for high-
grade/major abnormality on cervical screening >50

21. EFC Quality indicators
2015 EFC satellite meeting - Consensus revisions
Parameter Aim
1. For cervical colposcopy TZ type (1,2 or 3) should be
documented . 100%
2. Percentage of cases having a colposcopic examination prior
to treatment for abnormal cervical screening test 100%
3. Percentage of excisional treatments/conizations have a
definitive histology of CIN2+. Definitive histology is highest
grade from any diagnostic or therapeutic biopsies >85%
4. Percentage of excised lesions/conizations with clear
margins >80%
5. Number of colposcopies personally performed each year for a
low-grade/minor abnormality on cervical screening >50
5. Number of colposcopies personally performed each year for
high-grade/major abnormality on cervical screening >50
The revised EFC Quality Indicators 2017
will be published as full paper but with comments to allow
national societies and/or governments
to define lower aims for national QA and/or to replace
the „clear margin“ QI (No.4)

22. Better Quality indicators ahead?
Quality indicator Aim
For cervical colposcopy TZ type (1,2 or 3) should be
documented
>95%
Percentage of cases having a colposcopic examination prior to
treatment for abnormal cervical screening test
>95%
Colposcopy with punch biopsies in </= LSIL and type 1 or 2 TZ
with minor or major changes
>90%
Excisional treatments/conizations have a definitive histology of
CIN2+. Definitive histology is highest grade from any diagnostic
or therapeutic biopsies (exclude type 3TZ + age 40+)
>80%
Rate of HPV negative cases 6 months after excisional
treatment
> 80%
A proposal for the EFC congress 2019 in Rome

23. Conclusions
• The basics of colposcopy should be part of any OBGYN
training but this does not qualify to practise colposcopy
in women with atypical screening results
• Colposcopists need to pass a well defined education
and training programme with exit assessment
• A continous QA of colposcopy practice is needed
• External QA is better than self QA. External QA should
be organised by national societies for colposcopy and
harmonized by EFC.
• QA of education, training and practice in colposcopy
can be delivered in private and public health sectors,
remote and rural as well as urban areas.

24. Outlook
• Full publication of EFC´s revised Quality
indicators, core competencies, standards in
education and training.
• Ongoing improvement of Quality Indicators
and standards
• Search for financial support to develop a
European Colposcopy Benchmarking Pilot
Project based on EFC QI and standards