Consensus on Quality Standards for Colposcopy and Colposcopy Training From the Latin-American Federation of Lower Genital Tract Pathology and Colposcopy

Abstract

Objective

The aim of the study was to provide recommendations on quality standards for colposcopy and colposcopy training.

Methods

A panel of experts from the Latin-American Federation of the Lower Genital Tract Pathology and Colposcopy agreed on quality standards for colposcopy and colposcopy training.

Results

A total of 17 general recommendations and the rationale behind them were provided. Eight colposcopy quality standards and nine standards for colposcopy training were issued.

Conclusions

Adherence to the proposed standards could help ensure quality care of women. Colposcopists must be trained and certified.

Colposcopy has a critical role in the prevention of cervical cancer (CC). According to data from the Pan American Health Organization (PAHO) in Latin-America and Caribbean (LAC) countries more than 78,000 women were diagnosed with CC in 2022, resulting in approximately 40,000 deaths, three times higher than in North America.¹ Following the World Health Organization's (WHO) worldwide Cervical Cancer Elimination Strategy, the PAHO set out goals for 2020–2030, aiming to increase human papillomavirus (HPV) vaccination, access to screening, and clinical care.²

Establishing quality standards for colposcopy and colposcopy training is essential to ensure safe, effective, and consistent care for patients. This approach may also improve the quality and uniformity of medical services. To achieve this goal in the LAC, a panel of local expert colposcopists gathered to write this consensus.

OBJECTIVE

The aim of the study was to issue recommendations on colposcopy quality standards and standards for colposcopy training.

METHODS

In 2024, the Latin-American Federation of Lower Genital Tract Pathology and Colposcopy (FLPTGIC) launched this initiative. The panel of experts was divided into two groups. Group 1, colposcopy quality standards and Group 2, training standards.

Methodology and timelines were shared and agreed upon. The first step involved a collaborative literature search using the following key words: (“colposcopy”) AND (“accuracy”) OR (“diagnosis”) (“uterine cervical neoplasms”) OR (“uterine” AND “cervical” AND “neoplasms”) OR (“uterine cervical neoplasms”) OR (“cervical” AND “cancer”) OR (“cervical cancer”) AND (“diagnosis”) OR (“diagnosis”) OR (“screening”) OR (“mass screening”) OR (“mass” AND “screening”) OR (“early detection of cancer”) OR (“early” AND “detection” AND “cancer”) OR (“early detection of cancer”) AND (“female” AND “adult”) AND (“Colposcopy/methods”) OR (“Colposcopy/statistics”) AND (“numerical data”) OR (“Colposcopy/utilization”) AND (“female” AND “adult”). Groups met online to define quality standards following a critical review of selected articles.

RESULTS

A total of 17 recommendations were issued, eight related to colposcopy quality standards and nine to training. The use of ‘may,’ ‘should,’ and ‘must’ reflects the panel's consensus.

A.1 Quality Standards in a Colposcopic Clinic

Rationale: Colposcopy quality management ensure safety and patients’ satisfaction. It should be evaluated through measurable indicators to identify areas of improvement.³

Recommendations:

1. All health care professionals must be certified.

2. All equipment and instruments must be in optimal condition.

3. Efficient work areas and safety waste disposal norms should be guaranteed.

4. Appointments and registries must be organized to reduce waiting times.

5. Effective communication between medical and administrative team is essential.

A.2 Patient Information: Counseling and Informed Consent

Rationale: Patients' rights, safety, autonomy, and well-being must be assured. The informed consent (IC) must be elaborate according to the national legislation and international norms. The signature of legal guardian(s) is required for a minor or a patient with cognitive disabilities.⁴

Recommendations:

1. IC must be provided in written form, in clear, complete and understandable language, with evidence-based information. The patient must understand the risks, benefits, and alternatives of the procedures before signing the document.

2. IC should include information about management of images and biological samples, as recommended by various National Institutes of Health and Medical Societies.⁵

3. No coercive influence should be exerted on the patient.

A.3 Medical Instruments, Equipment, and Supplies for Colposcopy

Rationale: Colposcopists require all essential equipment and supplies for diagnostic and therapeutic procedures.⁶

Recommendations:

Necessary equipment, medical instruments, and supplies should include the following:

1. Gynecological examination table

2. Colposcope

3. Side table carrying different size speculums, lubricant, antiseptic, Kogan endospeculum, vaginal wall retractor speculum (cut-out glove finger or condom if unavailable), disposable gloves, Ayre spatula, endocervical brush, slides, cellular fixative, gauze swabs, cotton-tipped swabs, cotton swab holder, 3%–5% acetic acid, Lugol's solution, Potocki needles, and Carpule syringes (or similar) for local anesthesia with lidocaine solution, lidocaine 10% topical spray, biopsy forceps, Kevorkian curette, hemostatic solution (Monsell, ferric chloride, or silver nitrate), bottles with 10% formalin, radiofrequency equipment, suture material, long needle holder, and long scissors.

Instruments must be sterilized with validated sterilization methods (liquid sterilizing solutions for plastic instruments, those requiring edge preservation, or those that cannot withstand high temperatures), and autoclaves for heat-resistant items.

Soaking in high-level disinfectants is only acceptable when autoclaving is not feasible and must follow manufacturer and infection control guidelines.

A.4 Results and Treatment Waiting Times

Rationale: Delays worsen prognosis and treatment response. Setting time limits ensures quality care.⁷

Recommendations:

Waiting times:

1. Colposcopy should be performed within 30 days of a positive screening test.

2. Histology results should be reported within 15–30 days after tissue biopsy.

3. Treatment, if needed, should start within 30 days of a positive histologic result.

A.5 Images Records or Maps

Rationale: Colposcopic images should be documented in paper or digital format for follow-up, peer consultation, and patient education.⁸

Recommendations:

1. Colposcopic images may be recorded in colpo-photographs or internationally approved mapping in all colposcopies.

2. Based on the colposcopic image mapping model proposed by the International Agency for Research on Cancer (IARC),⁸ we designed the following mapping, which could be used as a standardized tool for recording colposcopic images (see Figure 1).

3. The current IFCPC nomenclature⁹ proposed by the International Federation of Cervical Pathology and Colposcopy (IFCPC) should be used.

FIGURE 1.

Colposcopic mapping. We developed a diagram for documenting colposcopic images, following the recommendations for images registration proposed by the IARC/WHO.⁸

A.6 Artificial Intelligence in Colposcopy

Rationale: Artificial intelligence (AI)-based tools may improve biopsy site selection and diagnostic accuracy in colposcopy.¹⁰ However, current evidence does not support their benefits in diagnoses.

Nonetheless, a positive impact is expected in the future.

Recommendations:

1. AI systems that comply with ethical and regulatory international standards on data privacy and transparency may be employed in colposcopy.

A.7 Treatment and Follow-up of High-Grade Squamous Intraepithelial Lesion

Rationale: Diagnosis of HPV-related cervical lesions involves initial screening (Pap smear or HPV testing), colposcopy with biopsy if abnormal, results reporting, and appropriate follow-up or treatment. Patients with cervical cancer should be referred to an oncology center. Posttreatment follow-up must adhere to established protocols.^4,11

Recommendations:

1. Colposcopy must be done in all patients with: atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H), high-grade squamous intraepithelial lesions (HSIL), atypical glandular cells (AGC), and glandular lesions.

It should be performed in at least 70% of patients with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL). Triage with other tests—such as genotyping or methylation—may be considered where available.

• 2. Biopsy must be done in all patients with colposcopy grade 2. An endocervical study must be done in all patients with Type 3 Transformation Zone (TZ3), AGC, and glandular lesions.

• 3. Two to four biopsies should be performed.

• 4. At least 85% of patients should receive their biopsy results within 30 days.

• 5. Treatment should be initiated within 30 days of diagnosis in at least 90% of patients with HSIL.

• 6. All patients with invasive cervical cancer must be referred to a cancer center.

• 7. At least 75% of patients should assist to their treatment follow-up within the first year. Follow-up after treatment should be done between 6 and 12 months and then annually for 3 years. A clinically validated HPV test, with or without cytology, should be used as a test of cure. If an HPV positive test or an ASCUS+ cytology is obtained, colposcopy with endocervical study and biopsy of exocervical lesion, if present, must be performed.

• 8. Documented treatment and follow-up must be accessible to health care providers in all patients.

• 9. Therapeutic success should be guaranteed in more than 85% of patients.

A.8 Oncological Route: Referrals

Rationale: Early referral to oncological care improves quality of life and prevents withdrawal of therapy. An organized referral system is a quality measure of care.¹²

Recommendations:

1. A referral pathway to a gynecological cancer center should be offered.

2. An open and continuous communication between health care providers should be established with a focus on quality indicators, such as health care coverage, waiting times and treatment outcomes.

B. Quality Standards in Colposcopy Training

B.1 Colposcopy Clinic Set-up

Rationale: Knowledge of the set-up and management of a colposcopy clinic allows the colposcopist to identify areas for improvement, and enhance efficiency.¹³

Recommendations:

1. Colposcopists should oversee the colposcopy office set-up and ensure optimal conditions of the instruments to maximize efficiency and comfort

2. Colposcopists and clinical staff must ensure adherence to waste disposal norms.

3. An organized and efficient patient pathway flow should be in place.

B.2 Communications Skills

Rationale: Information and communication technologies have increased and patients demand shared informed decisions.

Articulate and empathic communication incorporating patients' experiences and feelings humanizes the medical act.¹⁴ The use of telemedicine by health care providers must protect patients' rights, dignity, and well-being.¹⁵

Recommendations:

1. When greeting a patient, introduce yourself briefly with eye contact and, if appropriate, a gentle touch on the shoulder. Ask about the reason for their visit with empathy. Call them by their name, always respect their dignity, support them through illness, and help ease their fears.

2. Explain all results and procedures clearly, using simple and understandable words.

3. Social media posts should be clear and evidence-based. You may set posting guidelines to avoid misinformation and to promote health education.

4. Ethics must be promoted in the use of information and communication technologies.

5. Telemedicine may be used for consultations and discussions with other health providers.

B.3 Biopsy

Rationale: Colposcopy sensitivity for HSIL increases with the number of biopsies¹⁶ taken from the most abnormal areas under colposcopic guidance.

Recommendations:

1. Two to four biopsies should be taken from the lesion in accordance with the percentage of cervical involvement.

2. Biopsies must be performed under colposcopic guidance.

B.4 Endocervical Assessment

Rationale: Curettage and brushing of the endocervix increase the detection of cervical intraepithelial neoplasia (CIN) but brushing causes less discomfort and pain.¹⁷

Recommendations:

Endocervical assessment must be performed on the following:

1. Patients >45 years of age

2. HPV16/18-positive patients

3. Patients >30 years of age with ASC-H, CIN 2, AGC, or glandular lesions

4. Patients with ASCUS or LSIL cytology, TZ 3, and no colposcopic lesion

5. CIN 2, high-risk HPV (+) in a previously treated patients, or ASCUS the in follow-up

B.5 Colposcopy in Special Populations: Pregnancy, Hysterectomized, Immunocompromised, Postradiotherapy, and Menopause

Rationale: Significant tissue and vascular changes in special patient groups make it difficult to distinguish between normal and pathological epithelium, requiring specific guidelines for each group.^18,19

Recommendations:

Pregnancy:

1. Colposcopists should be able to recognize physiological changes during pregnancy (e.g., decidualization, ectropion, and squamous metaplasia).

2. Biopsy all lesions suspicious of CIN 2+.

3. Colposcopists should follow diagnostic-therapeutic algorithms during pregnancy. For HSIL, quarterly cytology and colposcopy are recommended, with biopsy when invasive cancer is suspected.

4. Endocervical assessment must not be done during pregnancy.

Hysterectomy:

1. Screening should not be performed in patients with total hysterectomy (TH) due to benign conditions, with appropriate previous screening, no risk factors, and no history of CIN 2+.

2. Screening should be done with validated HPV-DNA tests (preferred) or cytology in all patients with TH and history of HPV-related lesions or with poor screening adherence.

Immunocompromised (e.g., individuals living with HIV, transplant recipients, or those on long-term immunosuppressive therapy).

1. Colposcopists should follow the appropriate screening and follow-up protocols for these population, using national guidelines where available.

2. Colposcopy should be performed in immunocompromised patients with ASCUS+ or positive HPV test.

Radiotherapy:

1. Colposcopists should know the effects of external and internal radiotherapy in LGT: atrophy, stenosis, and loss of tissue elasticity.

2. A green filter may be used for cervical vasculature assessment.

Menopause:

1. Colposcopists should know the effects of hypoestrogenism on the LGT.

2. Cytology or colposcopy should be performed/repeated 3 weeks after treatment with local estrogens in patients with atrophy, inadequate colposcopy, or ASCUS+ without cervical or vaginal lesion and negative endocervical sample.

3. A green filter must be used for cervical vasculature assessment.

4. Endometrial assessment must be performed when endometrial cells are identified on a Pap smear and in cases of postmenopausal bleeding.

5. Endocervical and endometrial samples must be obtained in patients with AGC or glandular lesions.

B.6 Indications for Vulvar/Vaginal Examination and High-Resolution Anoscopy

Rationale: Multizonal assessment of the LGT allows the detection of a great number of preinvasive lesions.

Recommendations:

1. Colposcopists should evaluate the vagina (vaginoscopy) and the vulva (vulvoscopy) when colposcopy is performed.

2. Colposcopists should have a wide knowledge of the vaginal anatomy. The use of Lugol's solution may facilitate the detection of vaginal intraepithelial neoplasia.

3. Following the recommendations of the International Anal Neoplasia Society (IANS),²⁰ high-resolution anoscopy—a technique that uses magnification and acetic acid to detect high-grade anal intraepithelial neoplasia (AIN)—should be considered for AIN screening in:

• All women over 45 living with HIV

• In women with history of vulvar HSIL or vulvar cancer, within the first year of diagnosis

• In solid or hematopoietic organ transplant patients, within the first 10 years

Shared decision making is recommended for women ≥45 with:

• History of cervical or vaginal HSIL or cancer

• Perianal warts

• Persistent (>1 y) cervical HPV16

• Autoimmune conditions (e.g., rheumatoid arthritis, SLE, Crohn's disease, ulcerative colitis, or systemic steroid therapy)

B.7 Colposcopic Nomenclature

Rationale: Colposcopic evaluation with appropriate and updated terminology is essential for a successful treatment.²¹

Recommendations:

1. The current IFCPC nomenclature must be used.

2. Excisional treatment must be colposcopy-guided and according to the TZ type.

3. Colposcopists should practice precision medicine by individualizing treatment, avoiding unnecessary conizations, and ensuring clear communication with the patient and the health care team.

B.8 Health Care Providers Collaboration

Rationale: Collaboration and discussion among health care providers enhance quality and improve patient outcomes.²²

Recommendations:

1. Health care providers may be updated by attending meetings and participate in training sessions.

B.9 Colposcopy Training and Evaluation of Postgraduate Students Must Be Certified by Local, National, or International Societies of Lower Genital Tract Disease and Colposcopy or University Programs

Rationale: Colposcopy training and evaluation of students’ progress are crucial to achieve an adequate colpo-histological correlation and high standards of patient care.²³

Recommendations:

In order to obtain certification in colposcopy, a student must:

1. Complete a theoretical course (in person or online)

2. Maintain a logbook ascertaining:

   • 2.1.a minimum of 150 colposcopies: 50 under direct supervision (10 with HSIL confirmed by biopsy) and 100 under indirect supervision.
   • 2.2.a minimum of 10 observed excisional and 10 performed excisional procedures under direct supervision.
   • 2.3.a colpo-histological correlation rate >80%

3. Written and practical evaluation of learning:

   • 3.1.The theoretical written evaluation may consist of 50 multiple-choice questions, with a cutoff value >60%.
   • 3.2.Both, theoretical and practical evaluation, may cover the topics proposed in the consensus, as well as basic and advanced knowledge of LGT diseases.
   • 3.3.Practical evaluation of the students may involve a real or simulated patient. A grading scale from 0 to 2 may be used, where 0 indicates poor performance, 1 regular performance, and 2 good performance. Items that may be evaluated include:

   • a. Communications skills

   • b. Elaboration of medical records

   • c. Information provided to patients (must be complete and understandable)

   • d. Understanding the reasons for referral

   • e. Explain to patients the natural history of HPV infection and cancer risk

   • f. Explain to patients colposcopic findings and the need for a biopsy

   • g. Explain to patients treatment options, follow-up, and associated risks

   • h. HPV vaccination counseling

   • i. Evaluation of patient's understanding of the information provided

   • j. Decision-making skills.

   • 3.4.The previous items may be evaluated on a scale from 0 to 20 and a grade >12 (60%) should be achieved.
   • 3.5.The final grade may include all the items included in written and practical exams.

DISCUSSION

In 2024, the incidence and mortality rates of CC in LAC were 21 and 10.1 per 100,000 women, respectively.²⁴ The ESTAMPA study evaluated colposcopy performance in the region,²⁵ highlighting significant variability in both quality and training practices.²⁶

Improving them may be a step forward to reduce incidence and mortality rates.^27,28

Colposcopy can be used as a primary screening test, particularly when HPV-DNA testing is not affordable. However, there are not quality standards for this region, and there are limited colposcopy training opportunities since there are few scientific societies of LGT pathology, restricted training sites, and heterogeneous training standards. The WHO²⁹ and PAHO³⁰ promote HPV vaccination, early diagnosis and treatment of precancerous lesions, and improved health care access as cost-effective strategies.

The FLPTGIC consensus proposes quality standards for colposcopy and training, as a step toward improving care and reducing CC burden and encourage health care professionals involved in CC prevention to adopt this consensus, implement risk-based patient evaluation, and enhance care quality through ongoing audits.

CONCLUSIONS

Cervical cancer remains a major public health issue in LAC. Poor quality control and lack of standardized clinical care contribute to suboptimal outcomes. To address this, the FLPTGIC developed a consensus on quality standards for colposcopy and training, aiming to improve women's health care in the region.