Regulatory Approval of Mobile Mammography Screening Programs Focused on Underprivileged Communities in Bulgaria. πŸ“

Author: Dimitrana Angelova, Gueorgui Gueorguiev, Kremena Ivanova, Filip Simeonov πŸ‘¨β€πŸ”¬

Affiliation: National Centre of Radiobiology and Radiation Protection 🌍

Abstract:

Purpose: Mobile mammography screening programs focused on underprivileged populous in Bulgaria, such as the Romani people, are of great importance as such populations often don’t have access or are reluctant to visit a conventional health care facilities. This work aims at streamlining and reducing the time such screening programs are regulatory approved by developing a procedure checklist.

Methods: Out team developed a checklist describing in detail the three steps every mobile mammography screening program conducted in Bulgaria must comply in order to be regulatory approved and clinically implemented. Step 1: Submission of the proposed screening program and the supporting documentation to the government regulatory body (National Center for Radiobiology and Radiation Protection – NCRRP). Step 2: If submitted paperwork complies with the Bulgarian legislature, unconditional approval decision is issued. If minor changes are needed, conditional approval decision is issued. In this case the screening can start only after the changes are made and NCRRP informed. If submitted paperwork doesn’t comply with the legislature, decision of refusal is issued. It includes what the submitted program is lacking and suggestions to fix. Step 3: while conducting an approved screening program, the healthcare facility must record certain exam information for every patient, including patient gender, age, incandescent air kerma, average glandular dose, image projection and number of projections, compressed breast thickness. After program completion, this record is returned to the NCRRP.

Results: After development and introduction of the screening program checklist, the time for regulatory approval of mammography screening programs was significantly reduced to just 3 business days, provided all the necessary documents were submitted with NCRRP.

Conclusion: Development and implementation of a checklist for mammography screening program regulatory approval not only shortened the approval time, but also made it easier for healthcare facilities to successfully apply.

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