Colposcopy:

Standards for Technique

and Documentation
ASHLYN SAVAGE
Background
 Hundreds of thousands colposcopies performed every year

 Performed by Ob/Gyn, Family Practice, Internists, NPs, PAs

 Large country, many remote areas that need coverage but have low
volumes

 No nation-wide integrated healthcare system, no screening or precancer

registries

 Training is highly inconsistent: Residency, courses (e.g. ASCCP),

mentorship training, self-education

 No formal certificate of colposcopy competence

 No formal colposcopy guidelines/ standards

Vignettes…WWYD

 24 yo G0 with ASC-H pap smear

 Repeat pap in 6 months
 Add HPV testing
 Colposcopy – if no lesion then no biopsy
 Colposcopy – If no lesion then ECC and Random bx
 “See and Treat” Leep
 45 yo G4P4 with HSIL Pap that was
positive for HPV 16
 Colposcopy, if no lesion then ECC
 Colposcopy, if no lesion then ECC and Random Bx
 “See and Treat” Leep
 Refer to GYN Oncology
Let’s describe this Colpo
A. Adequate?
B. Lesion Present?
A. Character?
B. Borders?
C. Vascular features?
D. Location?
C. Would you biopsy?
A. Where?
B. More than one?
D. Colposcopic Impression?
1. Adequate?
2. Lesion Present?
1. Character?
2. Borders?
3. Vascular features?
4. Location?
3. Would you biopsy?
1. Where?
2. More than one?
4. Colposcopic Impression?
IMPROVE-COLPO Study
Two-arm study
 Setting: US community-based clinics offering colposcopy
 Population: women ≥21 yo referred for colposcopy
 Pragmatic “real world” practice
 Active arm: outcomes with DYSIS colposcope (prospective colposcopies)
 Control arm: standard colposcopy outcomes (retrospective data by chart
review )
 IRB-approved, Clinicaltrials.gov: NCT02185599

Outcome measures
 Detection of CIN2+, number of patients biopsied, number of biopsies

Recruitment to date
 44 clinics across 12 states, 160 providers
 30 clinics have completed participation
 >6,800 women recruited across the two arms
IFCPC 2017 World Congress Oral Presentation – Warner Huh
Practice and Population Profile
44 community-based colposcopy clinics
 Teaching hospitals: 2
 Large private clinics (3-15 providers): 24
 Small private offices (1-2 providers): 18

160 Providers
 Obstetrician/Gynecologists, Gynecologic Oncologists
 Nurse Practitioners, Physician Assistants

Patient characteristics (N=3,404)

 Median age 34 years old
 Menopausal: 11.8%
 88.3% privately insured
 Low incidence of CIN2+ disease (13.6% overall)
 86% referred from screening with “lesser abnormalities”
Colpo Referral Patterns
Referral patterns among women age 21-24

High Grade (N=82)

HSIL, ASC-H, AGC 10.2%

Low Grade (N=704)

LSIL, ASCUS and HPV 87.5%

Cytology Only 57.4%
Had HPV co-test 30.1%

• Women < 25 are frequently co-tested for HPV

• Women < 25 are frequently undergoing colpo for
low grade abnormalities
 # of biopsies per N(%)

Approach to patient
None 1036 (30.4%)
Biopsy 1 1547 (42.8%)
2 705 (20.7%)
3 183 (5.4%)
 Many women undergo 4 22 (0.6%)
ECC 5 0 (0%)
 Cervical biopsy is Random 28 (0.8%)
practiced conservatively
Avg (Median)
Overall 1.03 (1)
High Grade (n=412) 1.48 (1)

Low Grade (N=2926) 0.98 (1)

Age 21-24 25-29 30-55 >55 Total

Patients 444 720 1958 254 3404
(N)
ECC 266 517 1514 199 2946
(59.9%) (71.8%) (77.3%) (78.3%) (73.3%)
 Documentation and
Treatment
 Colposcopic impression rarely documented
 40% of charts note impression

 “See and Treat” Leep Rarely Done

Excision at time of colpo for High Grade referral

Age 21-24 25-29 30-34 41-55 > 55 Total

Number 51 102 140 85 34 412

“See and Treat” (n) 1 0 2 2 0 5

Follow up

 Follow-up is often recommended at 6 months

rather than 12 months

Plan for pap smear follow-up

Histology Result

Interval No result Result = CIN 1 Total

normal
6 months 214 633 413 1260

12 months 123 577 332 1032

ASCCP Colpo Standards
Project
 Four Working Groups:
 WG1: Role of colposcopy, benefits,
potential harms, and terminology
 WG2: Risk based colposcopy practice
 WG3: Colposcopy procedures and
adjuncts
 WG4: Quality Control
WG1: Standardize Terminology
 Simplify and clarify mechanism of colpo documentation across breadth of colposcopists
 IFCPC terminology was adapted to fit colposcopy practice in the US
WG2: Colposcopy practice can be modified
based upon risk assessment and colposcopic
impression

 If
risk of HSIL is very low, more expectant
management is appropriate

 Ifrisk is intermediate, multiple biopsies leads

to increased detection

 Ifrisk is high, then immediate treatment is

recommended
 The Low Risk Patient
Biopsy may be deferred if:
 Less than HSIL cytology, no known HPV16/18 positivity, and a normal
colposcopic impression (i.e. no acetowhitening, metaplasia, or other
visible abnormality)
Intermediate Risk
Multiple biopsies targeting all areas with aceto-whitening,
metaplasia, or other high grade features should be collected.
• At least two, and up to four, biopsies from discrete lesions
should be taken.

*a single biopsy targetting the “worst” area may miss up to a 1/3 of prevalent high
grade lesions
High Risk
Recommend ‘See and Treat’ LEEP in non-pregnant women age
>25 with at least two of the following:
 HSIL cytology
 HPV 16 or 18 positivity
 High grade impression on colposcopy
Rationale for Including
Colposcopic Impression in
Decision
 Systemic Review 13 studies / N= 4611 patients
 Among women with HSIL pap and high grade colpo impression,
90% confirmed to have high grade disease on LEEP path
 Over-treatment rate is about 10%
 No different that over-treatment rate associated with two step
approach
 If HSIL pap and low grade impression, over-treatment rate was
29%

 Advantages to See and Treat:

 better compliance, lower cost, less angst

Ebisch et al. BJOG Jan 2016

WG3: Colposcopy Procedures
Sample Collection
Documentation of
Colposcopy
.ascolpo
60 y.o. G2P2 presenting for colposcopy.
She has the following complaints today: None
Patient Pregnant: {YES/NO:25502}

Referral Pap Smear / Date:

Pap Smear / Colposcopy History:

LMP:

Contraception: {GYN CONTRACEPTIVES:27677}

Tobacco use: {Tobacco Use:21540}

Past Medical History:

COLPOSCOPY PROCEDURE DOCUMENTATION:
PROCEDURE NOTE:
Patient was consented for colposcopy including possible cervical biopsy and endocervical
curetting. The vulva was normal in appearance with no evident skin lesions. With the patient in a
dorsal lithotomy position, the cervix was visualized with a speculum and noted to have a grossly
normal appearance. The cervix and upper vagina were cleansed with dilute acetic acid and
visualized with low- power magnification with the colposcope.

Findings:
 Colposcopy Adequate: {YES/NO:25502}
 Transformation zone seen: {YES/NO:25502}
 Endocervical Speculum Needed: {YES/NO:25502}
 Lesion Character:
 White Epithelium noted: {YES DESCRIBE WITH CLOCK:26717}
 Punctation noted: {YES/NO:25502}
 Abnormal vessels noted: {YES/NO:25502}
 Mosaicism noted: {YES/NO:25502}
 Endocervix involved: {YES/NO:25502}
 Lugol's Used: {YES/NO:25502}
Specimens collected:
Pap: {YES / NO:22259}
Biopsy taken: {YES DESCRIBE WITH CLOCK:26717}
ECC performed: {YES/NO:25502}
Vaginal Biopsy: {YES / NO:22259}
Vulvar biopsy: {YES / NO:22259}

Patient tolerated the procedure well and left the office in stable
condition.

COLPOSCOPIC IMPRESSION: : {OBGYN COLPOSCOPY

PREDICTION:26716}
If treatment is indicated would recommend:

Patient will follow up {GEN CONTACT METHODS:26718} to discuss

results.
 WG4: Minimum and
Aspirational Quality Measures
Minimum Aspirational
Documentation
Adequacy 90 100
Lesion present (yes / no) 90 100
Colposcopic impression 80 100
Cervix visibility 70 100
Extent of lesion 70 100
Location of lesion 70 100
Provider should take multiple biopsies targeting all 85 100
acetowhite areas (at least 2, up to 4)
Patient’s with results suggestive of invasive disease 60 90
she be contacted within two weeks, and should
be seen within two weeks of contact
Patients with results suggestive of high grade disease 60 90
she be contacted within 4 weeks and seen
within 4 weeks of contact
Summary

 Consider a template for you colpo

documentation

 Biopsy liberally

 Consider “See and Treat” LEEP