asst. prof. Urška Ivanuš, MD, Public Health Specialist
Last update: December 18 2020

• Organised, population-based, nationwide screening was implemented in 2003.
• Programme is comprehensive and includes invitations, screening, diagnostics, treatment and follow-up after treatment. It is managed according to Council recommendation on cancer screening (2003), European guidelines for quality assurance in cervical cancer screening (2008 and second edition supplements in 2015).
• Programme is managed from the central ZORA coordination office, Institute of Oncology Ljubljana, who provides guidelines, collects data, monitors and evaluates each step of the process.
• Programme services are provided by around 350 gynaecologist teams on the primary healthcare level (screening, diagnostic of low-grade lesions and follow-up after treatment) and secondary and tertiary level (colposcopy, invasive diagnostic and treatment, multidisciplinary assessment and management of difficult cases), as well as 9 cytology, 2 HPV and 11 histopathology laboratories.

• Target population: women aged 20–64.
• Screening test: Pap smear (conventional) within a primary health care network of gynaecologists.
• Screening interval: every 3 years, after 2 negative screening Pap smears in 12 months upon entrance to the programme.
• Triage of low-grade lesions: HPV triage test, Pap smear.

• With free access to their personal gynaecologists, women do not need a special invitation to schedule a screening appointment. 
• If a woman fails to make an appointment on time, her personal gynaecologist should invite her to make one (with a reminder if needed) in 3 years +/- 3 months after the last one. 
• The central coordination office with ZORA registry serves as a final supervisor of screening attendance. Women without cytology result registered for four years, receive a central invitation (with an additional reminder if needed), which is sent to woman in the fifth year.

• Non-responders: personal gynaecologist can activate field nurse to visit non-responder or contact her general practitioner, especially if woman is a non-responder to diagnostic or treatment invitation.
• Italian and Hungarian minorities: women with permanent residency in bilingual cities and villages receive bilingual invitation to screening and information leaflet.

• Central ZORA coordination office provides regular educational opportunities for all professionals involved in screening, diagnostic, treatment or follow up after treatment, many times in collaboration with national professional societies. 10th educational day of ZORA programme was organised virtually in 2020 with attendance of around 600 professionals of different expertise involved in ZORA programme. Other educational events include cytology and pathology workshops, basic and advanced colposcopy courses and many more. All cytoscreeners need to go to School for cytoscreeners and perform QUATE exam.

• Evidence-based, national guidelines for management of women by gynaecologists and management of her samples in cytology and HPV laboratories were extensively revisited and implemented in 2011, and for histopathology in 2015.
• All guidelines and recommendations are available in Slovenian here.

• Continuous and comprehensive monitoring and evaluation that cover both organised and opportunistic screening are performed systematically and ad hoc, if needed, from data registered routinely at ZORA registry.
• Reporting to national stakeholders: Annual reports with selected process and outcome results are sent to the government, National Cancer Control Plan and Health Insurance Institute of Slovenia and presented to National Screening Management Board at MoH. 
• Feedback to service providers: Personalised reports with information about the amount, result and quality of their work are sent to all Slovenian gynaecologists, and all laboratories for cytology, HPV and pathology once per year. 
• Public presentation and discussion of annual report: Monitoring and evaluation result are presented and discussed with screening providers, decision-makers and other stakeholders each year at ZORA educational day. Annual report is published on the ZORA webpage.  
• Auditing: Audit is performed for all women who were diagnosed with cervical cancer and attended the ZORA programme. Their cytology smears are revisited blindly with 2 matched controls per case by each of four members of the Cytopathology expert group. Consensus is reached for samples difficult to interpret. 
• Fail-safe mechanism: Central coordination office monitors attendance of women with pathological cervical findings in the ZORA registry and yearly sends lists of women without follow-up examinations to their personal gynaecologist with a request for the identification of reason for non-respondance.

• ZORA registry is managed by the central ZORA coordination office at Institute of Oncology Ljubljana.
• ZORA registry was established in 1998 and was implemented on a national level in 2003 as a centralised database of Slovenian women demography with nightly synchronisation with the Central Population Registry. Women are linked by EMŠO, an unique personal identification number in the Republic of Slovenia.
• ZORA registry routinely registers all cervical cytology, HPV, cervical histopathology and hysterectomy reports, regardless of women's age or reason for smear taking or invasive procedure. Data providers are, by the law, all Slovenian laboratories. Cytology and HPV data are standardised and received in electronic format as defined by the methodological guidelines. Histopathology reports are not yet standardised and are received as a paper copy of the original report. They are coded and entered into ZORA registry at the central ZORA coordination office. Bethesda classification 2015 is used in cytology and WHO classification in histopathology.
• ZORA registry also registers all invitations, women’s answer on the survey added to invitation, information about non-attendence to diagnostics or treatment and providers answers to request for the identification of reason of non-responders with cervical pathology.
• All data in ZORA registry is structured and personalised.
• Regular monitoring of data completeness and data irregularities is performed and laboratories, as well as gynaecologists, are requested to provide missing data and solve irregularities.
• Once per year, ZORA registry bilaterally exchanges personalised data on all women with CIN and cervical cancer with the Cancer Registry of the Republic of Slovenia, with the aim to check the completeness and quality of data in both registries.  
• ZORA register under renewal. New register will serve as direct communication platform for screening providers, who will exchange electronic requests and reports. It will be in openEHR format, integrated as a satellite system with national eHealth platform. New data will be routinely registered (colposcopy, HPV vaccination status) and electronic connections with new databases established (HPV vaccination registry, health insurance database, register of health workers). More information can be found here.

• Healthcare Databases Act. (Official Gazette of the Republic of Slovenia, No. 65/2000) and Act Amending the Healthcare Databases Act (Official Gazette of the Republic of Slovenia, No. 31/18).
• Rules for cytopathological laboratories requirements for processing and analysing cervical samples (Official Gazette of the Republic of Slovenia, No. 68/2001 and 128/2004).
• Rules of laboratory requirements in the field of laboratory medicine (Official Gazette of the Republic of Slovenia, No. 64/2004 and 1/2016).
• Rules on the implementation of national cancer screening programs (Official Gazette of the Republic of Slovenia, No. 57/18 and 68/19).

• Health Insurance Institute of Slovenia is funding all programme services as well as programme management.