The colposcopy procedure should be standardised. For professional colposcopy physicians, their indications and procedures can be assessed by reviewing colposcopy records or observing their actual colposcopy operations (table 1). Internal evaluations should regularly involve senior doctors from the institution randomly selecting 10% of colposcopy cases. External evaluations are conducted by an expert panel reviewing a period of colposcopy records and 10–20 colposcopy records to assess the compliance with indications, the procedural flow of colposcopy and the standardisation of colposcopy reports8 10–16 (table 2).
Indications for colposcopy
The indications for colposcopy should be correct,5 6 and 100% should be recorded. The proportion of colposcopy evaluations that meet the indications should be ≥80%.
The specific indicators are as follows:
Abnormal cervical cancer screening results
Human papilloma virus (HPV) 16 or 18 positive, or other HPV high-risk subtypes persistently positive.
Cytology exam from Bethesda system (The Bethesda System) indicating low-grade squamous intraepithelial lesion (LSIL), atypical squamous cells-cannot exclude high-grade squamous intraepithelial lesion (HSIL) (ASC-H), HSIL, squamous cell carcinoma, atypical glandular cell (AGC), adenocarcinoma in situ (AIS), and adenocarcinoma, or ASC of undetermined significance with positive HPV test.
Abnormal clinical findings
Suspicious cervical ulcer, tumour, or polyp or suspected cancer by clinical exam.
Unexplained lower genital tract bleeding or contact bleeding, unexplained vaginal discharge, etc.
Vulvar and vaginal HPV-related squamous epithelial lesions
Follow-up after treatment of precancerous lesions of the lower genital tract
Colposcopy operation
Colposcopy should be performed according to the guidelines,6 8 17 with the operation standard rate being ≥90%. The specific operation should meet the following steps:
Observation and evaluation
The patient is placed in the lithotomy position. After examining the external genitalia and perianal area, an appropriately sized speculum is inserted to observe the appearance of the entire vagina and cervix. The cervix and vaginal epithelium are moistened with physiological saline to remove mucus, facilitating observation and assessment. The observations and assessments should include the following:
Observation and documentation of the adequacy of colposcopy
The cervix should be fully exposed under the colposcope, and factors affecting the colposcopy should be assessed, such as bleeding, inflammation, scarring, etc. The visibility of the upper boundary of the cervical squamous columnar junction (SCJ) and the upper boundary of the lesion, as well as the type of transformation zone (TZ), should be assessed and recorded.
The proportion of colposcopy documentation evaluated to assess the adequacy of colposcopy should be ≥90%.12
Observation and documentation of the visibility of SCJ and TZ types
Cervical SCJ is the position where cervical squamous epithelial cells and columnar epithelial cells are adjacent, and the TZ is the area between the original SCJ and the new SCJ, where cervical cancer is prone to occur. Therefore, it is very important to evaluate and record whether SCJ is visible and to evaluate TZ types.16 18 19
American Society for Colposcopy and Cervical Pathology (ASCCP) recommends that ≥90% of colposcopy cases should record SCJ visibility,8 while the European Union recommends 100% should be recorded.11 Considering the actual situation in China, this consensus suggests that the proportion of colposcopy reports recording SCJ visibility and TZ type should be ≥90%.
Acetic acid test
Cover the vaginal and cervical areas of the cervix with a cotton ball soaked in 3%–5% acetic acid for 60 s. Then, determining the TZ types and observing the changes in the cervical and vaginal epithelium and blood vessels under both low and high magnification. For Type 2 and 3 TZs, using an endocervical speculum or other instruments to observe the TZ and the upper boundary of the lesion. Slowly rotate the speculum to ensure that the anterior and posterior walls, as well as the lateral walls of the vagina, are fully visible. If necessary during the examination, repeat the acetic acid application after 3–4 min. When required, use 5% compound iodine solution for staining.
The changes in cervical epithelium and blood vessels observed under colposcopy after the acetic acid test should be recorded. Acetic acid can undergo a reversible reaction with keratin and nuclear proteins within epithelial cells; the acetic acid test is an important method for assessing whether there are any abnormalities in the cervix.6 The acetic acid test is a necessary procedure in colposcopy, and the colposcopist should document the results of the acetic acid test, including the colour, borders, contours, duration, degree and location of the acetic acid-stained epithelium, to facilitate impression judgement during colposcopy and determine whether a biopsy is needed. The proportion of colposcopy records of the acetic acid test should be 100%.
A thorough observation of the lesion’s extent is crucial for assessing its severity and determining further management. The 2011 International Federation for Cervical Pathology and Colposcopy recommends recording the location of the lesion, the visibility of its borders, the area affected, the quadrants involved and the relationship between the lesion and TZ, or other details.12
The proportion of documented lesions should be ≥70%.
Documentation of colposcopy impression
The detection rates of HSIL and higher (HSIL+), including cervical intraepithelial neoplasia (CIN) 2, CIN3, AIS and invasive cervical cancer, are closely related to colposcopy impression. ASCCP uses colposcopy impressions as one of the risk stratification indicators.15
Colposcopy impression should be determined based on changes in the cervical epithelium and blood vessels. The findings should be described using relevant colposcopic terminology, including (normal/benign; low grade; high grade; cancer). Additionally, the assessment impressions of the vagina, vulva, perianal area and other regions should also be documented.
The proportion of documentation of colposcopy impression should be ≥80%.
Biopsy
For any abnormalities found by a colposcopy exam, a biopsy should be performed to confirm the diagnosis through histopathology. Common biopsy methods used in colposcopy include targeted biopsies and endocervical curettage (ECC). Samples from different areas should be labelled separately and fixed in 10% neutral formalin solution before being sent for pathological examination. The documentation of colposcopy should indicate whether a biopsy was performed, and if so, the method and site of the biopsy should be recorded.
The proportion of biopsy procedures with documentation of colposcopy should be ≥90%.
Colposcopy-directed punch biopsies
Biopsy should be performed at 2–4 biopsy sites in any discontinuous acetic acid-stained area or suspicious lesion. If only one biopsy is taken from the most severe lesion, it may miss up to one-third of precancerous lesions; multiple-site biopsies can increase the detection rate of HSIL+.20 It is recommended to take 2–4 samples to enhance the detection rate of HSIL+, and to document the sampling sites for histopathological diagnosis and subsequent treatment.8
For cases with abnormal cervical cancer screening results but no abnormalities found on colposcopy, random biopsy can increase the detection rate of precancerous lesions of cervical cancer,20 21 especially for patients with ASC-H, HSIL or AGC. It is recommended to evaluate patients who have no abnormalities on colposcopy and without vaginal lesions based on age, previous cervical cancer screening history, treatment status and current cervical cancer screening results. If necessary, random biopsies of all four quadrants of the cervix can be performed.
Endocervical curettage
A colposcopy exam cannot adequately assess abnormalities of the cervical canal; performing ECC can help understand the condition of lesions within the cervical canal, especially when TZ is not visible, making ECC examination particularly necessary.22 23 Decisions on whether to perform ECC should be based on screening results, history of precancerous lesion treatments, colposcopy impression and TZ type. It is important to note that pregnancy is contraindicated for ECC, and the indications for ECC are as follows6:
TZ cannot be fully visible.
Having high-risk factors (≥40 years old, cytology results were ASC-H, HSIL, AGC or AIS and HPV16/18 positive).
Having HSIL+ treatment history.
Following up with HSIL (CIN2), etc.
ECC may not be performed in the following situations: (1) Cervical resection is planned; (2) The cervical canal cannot be entered with a curette and (3) Cytology exam is ASCUS or LSIL and age <30 years of non-childbearing women.
Haemostasis
After biopsy, press the biopsy site with a cotton ball. If there is active bleeding, use gauze with a tail to press the wound, and instruct the patient to remove it by themselves after 4 hours. Also, it can use haemostatic drugs to press the wound.
Documentation of colposcopy findings
Colposcopy findings should be documented (table 1).
Providing management recommendations
Explain the results to the patient, and make more detailed management suggestions for colposcopy, follow-up time, and guidance for nursing after discharge according to the specific conditions of the patient (such as age, fertility requirements, immune status, etc), and document.
After a colposcopy evaluation, further management recommendations should be provided. For patients with completely normal colposcopy results and low-risk screening who have not undergone biopsies, the time and content of follow-up should be communicated. Patients who undergo biopsies should be scheduled for a return visit within 2 weeks to inform them about the pathology results and to develop a subsequent treatment or follow-up plan. In conjunction with lifestyle factors (such as smoking, sexual behaviour and contraception), personalised health guidance should be provided, such as vaccination, to reduce the risk of cervical cancer.
The proportion of management recommendations documentation of colposcopy should be 100%.
The biopsy specimen meets the requirements of pathological preparation.
The biopsy specimen should be taken with colposcopy operation specifications, and the sampling site should be marked in detail. When conditions permit, it is recommended that specimens from different sampling sites be placed in different pathological bottles containing 10% neutral formalin, respectively, so as to better identify the degree of lesions in different sites.
The proportion of biopsy specimens that meet the requirements of pathological preparation should be ≥90%.12
