https://orcid.org/0000-0001-9942-1478
Abstract
This study presented the role of regulatory bodies in promoting patient safety and benefits within mammography facilities. The model of potential risk assessment method was applied over 4 yrs (2019–2023). An instrument based on national and state mammography normative objective inspection script was created to harmonize the regulatory actions. The study recorded average glandular dose (AGD) over 4 y, with data categorized by mammography unit manufacturer and model. According to the mammographic manufacturer and model, the AGD ranged from 1.03 to 5 mGy. The inspection results related to the risk potential assessment; the onsite inspection resulted in 29 mammography services as acceptable, 12 as unacceptable, and 14 as tolerable. The potential risk assessment strategy implemented provided a robust regulatory framework and reflected a positive impact on patient safety.
Introduction
Patient safety regulation may be defined as the methods institutional actors employ to control, monitor, oversee, regulate, or modify healthcare facilities to reduce the likelihood of patients suffering damage [1].
The regulatory body plays a pivotal role in promoting safety in terms of health for workers and the public in general. Usually, the regulatory framework is based on various documents, laws, and statutes, which may be structured since it may vary according to the distinct legal country legislation [2]. Regulation violations could result in harsh penalties, including increased monitoring or even the cancellation of an operation [3]. Since the regulatory body works as a legal authority, the state should ensure effective independence, with no influence in its decisions [4, 5]. In parallel to the state’s regulatory action, other actions are promoted by professional associations or accreditation bodies that establish protocols complementary to the regulatory agency’s standards, such as the American College of Radiology [6], Joint Commission [7], American Association of Physicists in Medicine [8], and Spanish protocol of quality control [9].
In the USA, the Food and Drug Administration (FDA) is the government regulatory authority with an enormous scope of responsibilities that involve the security of human and biological products, medical devices, and products that emit radiation [10]. As an executive branch of the Department of Health, the UK government’s Medicines and Healthcare Products Regulatory Agency [11] ensures that medications and medical equipment are functional and reasonably safe. It collaborates with UK healthcare providers and other organizations.
In Brazil, the Brazilian Health Regulatory Agency (ANVISA) is an autonomous body linked to the Ministry of Health. It serves as the coordinator of the Brazilian Health Regulatory System, which operates nationwide. Its role includes controlling the manufacturing, distribution, and use of goods and services governed by health regulations.
A large number of people worldwide (~42.7 million) have experienced harm from unsafe medical care [12]. Investing in research development is crucial to changing the scenario and reducing risks to support quality and patient protection improvement. In addition, it is necessary to change the population’s perception of the authoritarian role of the regulatory body as a health protection agent [12–14].
One of the main concerns for patient safety is the risk of radiation-induced cancer by mammography exams. Mammographic imaging is widely used for screening purposes due to its availability and reasonable price and is usually the initial step in the diagnosis of breast cancer [15, 16]. In addition, another concern is regarding undetected tumors or suboptimally treated cancer due to the poor image quality. Regarding risk investigation, the MARP (model of potential risk assessment) model has been used as a potential risk assessment strategy in the sanitary control of health services [17]. Navarro [18] created the potential risk assessment (MARP) model, combining qualitative and quantitative methodologies. This model works by classifying risk control (RC) indicators and measuring potential risks in health services. Oliveira et al. [17] presented the following method in detail, which was applied in fluoroscopy-guided interventional procedures. The MARP model has been used in Brazil to control the sanitary control of health services. The model was introduced through a state-normative.
This study aims to demonstrate how the MARP can be applied in mammography services to enhance patient safety and guide decision-making. It explores how regulatory bodies can use this model to manage risks and ensure that technical and operational standards are followed. The study addresses the risk to patient safety in mammography services arising from regulatory non-compliance and insufficient risk assessment procedures. These challenges include the ineffective relationship between regulatory bodies and mammography facilities, further exacerbating patient safety risks.
This paper presents the findings of a significant risk monitoring methodology in the mammography field. It shows how sanitary surveillance can use this valuable method to implement policies that prevent services that do not meet technical and operational standards from being told to change their practices or cease operations.
Materials and methods
In this study, we describe the application of the MARP method used by state sanitary surveillance in the sanitary control of mammography settings over a 4-y period (2019–2023). The sample of this study included all mammography settings in the State of Santa Catarina, Brazil.
Currently, The State of Santa Catarina has 159 institutions of mammography, and all institutions were included in the sample of this study. The institutions were required to transmit the information to the State Surveillance of Santa Catarina, Brazil, using the State Information System of Risk and Potential Benefit (SIERBP) system.
An instrument based on national and state mammography normative, ROI (objective inspection script), was created to harmonize the regulatory actions (Fig. 1). This instrument has indicators classified as critical and non-critical. The distinction between a critical and a non-critical indicator lies in the severity associated with its compliance. A critical indicator is one whose non-fulfillment renders the operation of a service unfeasible, potentially compromising its essential functioning and the safety of those involved. In contrast, a non-critical indicator represents a potential risk, but its negative impact is less severe and acceptable, given that the benefits outweigh the potential harm. The regulated institutions previously had easy access to the ROI for their self-assessment. This instrument allows them to find the major risks, and the institutions may know what is necessary to comply with the regulatory framework.
Objective inspection script (ROI) with objective classification of indicators and criteria.
The average glandular dose (AGD) was recorded over 4 y. The radiation levels are categorized according to mammograph unit (manufacturer and model). All these data were transmitted to the regulator database via the SIERBP web system. SIERBP (https://sierbp.saude.sc.gov.br/default) is a web-based platform used to input regulatory inspection data and manage risk assessments, assisting in decision-making. The regulator inspector analyzed the results reported by the mammography institution, and the health surveillance inspector scheduled an onsite inspection following the ROI indicators. The regulator inspector used the SIERBP web-based platform to register their onsite inspections. After that, the results obtained by the ROI application during the onsite inspection were analyzed, and the mammography service was classified as acceptable, unacceptable, and tolerable. For obtaining the risk potential classification, it was calculated the RC value following equation 1. The indicators used in the inspection instrument are classified as critical (ICi) and non-critical (INCj), depending on the severity and possible associated risk. The indicators vary from 0 to 5, where 3 is the compliance of the norm. Levels 4 and 5 refer to great (meets more than what the norm determines) and excellent (presents requirements for excellence in care quality), respectively.
The first factor of the RC equation represents the square root of the geometric mean of N critical indicators, and the second factor is the arithmetic mean of M non-critical indicators:
The critical indicators can take the system to maximum potential risk if assessed as situation zero. The non-critical ones influence the risk value, but do not determine the maximum potential risk, except when their entire set is evaluated in the zero situation. After calculating the RC function based on critical and non-critical indicators, the potential risk (PR) is determined using Equation 2:
If an RC value is zero (indicating non-compliance with the norm), the potential risk will equal 1, as e−0 = 1, representing the highest potential risk and the worst-case scenario.
For this method, a potential risk value of ≤0.049 is considered acceptable. The potential risk is classified as tolerable when the assessment results fall between 0.049 and 0.360. However, it is considered unacceptable when the potential risk is >0.360.
Results and discussion
The MARP model was implemented in the State Surveillance of Santa Catarina, Brazil. It has become a reference model for regulatory bodies since it provides a balanced and unbiased approach to inspection [17].
The highest quantity of services with unacceptable levels was in 2019 (60%), mainly due to the adaptation period following updates to national regulations. In contrast, in 2020, there were no unacceptable mammography facilities. This result was not due to improvements in compliance but rather because the COVID-19 pandemic significantly disrupted routine inspections. The reduced number of inspections during this period limited the detection of potential non-compliance, and the reduced usage of mammography systems in some facilities further contributed to fewer recorded failures. Furthermore, unacceptable services decreased from 27.78% in 2022 to 9.09% in 2023, which may be attributed to the time needed to adapt to and implement the new norm. Based on these findings, we have proven that the MARP model, with effective inspections, leads to better results and can assist healthcare institutions to comply with the normative and promote patient protection and the regulatory body to monitor healthcare facilities. Figure 2 shows the decline in unacceptable institutions between 2022 and 2023, highlighting this improvement.
Onsite potential risk assessment per year (2019–2023).
Figure 3 shows the workflow and structure of data collection. Firstly, the regulated mammography institutions transmitted the periodic quality control test results in the SIERBP platform, where the MARP model is hosted. The quality control tests were performed daily, monthly, and yearly according to the national normative framework IN N°92/2021 [19] and State normative IN-DIVIS/SES/01/2014 [19], RN 02/2015 [20]. The quality control tests covered image quality (number of fibers, microcalcification, and mass), the reproducibility of automatic exposure control, and the compensation performance for different breast thicknesses. The test also included the AGD value and the accuracy and reproducibility of tube potential indicators. Additionally, tests included half-value layer, spatial resolution, collimation system accuracy, compression system alignment, breast thickness indication, presence of artifacts in the image, image uniformity, contrast-to-noise ratio, and effectiveness of the erased cycle. Furthermore, the luminance of monitors used for diagnosis or reporting and the illuminance of the report room were evaluated. This framework enabled regulators to monitor compliance with the tolerance of parameters and identify the mammography service with potential risk alerts. The inspectors from the regulator body visited these facilities, applied the ROI instrument, and assessed the MARP level.
The workflow of mammography service evaluation with MARP model.
Regarding inspection results related to the risk potential assessment, the onsite inspection resulted in 29 facilities being classified as acceptable, 14 as tolerable, and 12 as unacceptable over the years. Self-assessment proved to be a valuable strategy for patient safety, allowing institutions to identify and address non-compliance. However, discrepancies between self-assessment submissions and onsite inspection findings were noted, as inspectors often identified additional issues during visits. Self-assessment data enabled regulatory bodies to prioritize inspections of unacceptable institutions, improving efficiency.
The Brazilian Health Regulatory Agency has used the ROI instrument for a harmonization project in diverse health areas to standardize health surveillance actions [21]. Since the regulated institution has previous access to the ROI instrument, they avoid the surprise effect when the regulatory body comes to the hospital to perform the inspection. Another advantage refers to the ROI classification indicators with a responsive regulation approach, where the indicators have six levels, and all indicators are linked with the correspondent piece of the norm. Healthcare regulated institutions may be motivated to comply with the norm and encouraged to increase quality. Therefore, the regulatory body can overcome the population’s perception of an authoritarian role and inefficient interference as a health protector and benefit agent. Currently, the ANVISA presents a Brazilian landscape of diagnostic imaging services through the business intelligence (BI) system. BI system is a strategy for collecting, processing, analyzing, and visualizing data to support decision-making processes. Using the BI, a comprehensive dashboard with diverse indicators, allows the population to follow up on the results of the inspections obtained using the ROI [22]. In England, there is a similar strategy where the Care Quality Commission (CQC) [23]—an independent regulator—monitors, inspects, and regulates health services. CQC periodically publishes the results of what they find.
Self-assessments offer potential beneficial regulatory strategies in health services, including possibly avoiding bureaucracies [24]. The monitored self-assessment allows the regulatory body to make decisions. At this stage, it’s crucial to implement the concept of benefit. Given Brazil’s vast geographical dimensions and the logistical challenges associated with monitoring many mammography facilities, the limited number of regulatory staff highlights the need for an efficient and systematic approach to ensure effective oversight. For example, the case illustrated in Fig. 2 showed two mammography rooms in different services, where through monitoring, the regulatory body can prioritize the surveillance actions aimed at making decisions. Otherwise, the Regulatory Authority could spend time and money inspecting mammography services that follow the norm. The benefit–risk approach has been applied to assess a favorable effect (potential benefit) and an unfavorable impact (potential risk). This approach has been used by regulatory agencies such as the European Medicine Agency [25–27]. The FDA has used qualitative benefit–risk frameworks to assess human drug and biological regulatory decision-making [28].
The International Atomic Energy Agency highlighted the advantages of dose monitoring to maximize radiation protection for individual patients and the broader public [29]. In terms of radiation protection, radiation exposure from mammography procedures has special attention because the risk of breast cancer may be raised. Some legislations require collecting data about individual radiation exposures [30, 31]. The operational dose quantity measured in mammography procedures is the AGD. Regarding the radiation doses, Fig. 4 shows AGD values sorted by mammography model and manufacturer. These values were measured by the hospital medical physicist and subsequently transmitted to the regulatory web system. Discrepancies in AGD values were observed, which can be attributed to variations among manufacturers and models. Other factors may contribute to discrepancies, such as anode filter combinations (e.g. molybdenum, rhodium, tungsten), beam quality, and the Automatic Exposure Control system not being calibrated. The study also tracked the most frequently used mammography devices and monitored their radiation dose outputs. The AGD reference level in Brazil varies from 0.6 to 3.6 mGy, depending on the equivalent breast thickness. This study found AGD values ranging from 1.0 to 5.0 mGy, with a tolerance limit of <4.5 mGy for the maximum thickness. Figure 5 showed the AGD values and the number of doses registered from 2019 to 2023. It was noted that the number of registered data is increasing over time. The AGD remained consistent, varying by ~5% during this period. Some factors may explain these trends, including updates to national regulations between 2019 and 2023. The AGD values were calculated based on a standard breast thickness of 4.5 cm of Poly methyl methacrylate (PMMA). However, the values shown in Fig. 4 do not account for variations in detector technology (Computed Radiography or Digital Radiography), beam quality, and the use of automatic exposure control. Furthermore, the mammography equipment may have been updated during the study period. In total, 29,292 radiation doses were registered over 4 yrs.
Radiation doses for each manufactured and mammographic model, where n represents the number of collected doses. The dotted line indicates the maximum tolerated dose limit for 6 cm of PMMA, as defined by Brazilian mammography standards.
The AGD and the number of recorded doses during the period from 2019 to 2023.
In this study, AGD ranged from 1.03 to 5 mGy, depending on the mammographic manufacturer and model. These findings emphasize the relevance of setting diagnostic reference levels (DRLs) to align with global standards. The strategy presented in this study can assist the DRL’s creation according to diverse technologies (CR and DR) while incorporating image quality evaluations to balance radiation dose and diagnostic accuracy.
AGD variations may result from the contribution of diverse image receptor technologies and protocols [16, 32]. A study by Loveland et al. [33] on radiation doses in the UK between 2016 and 2019 reported an increase in mean AGD for digital mammography. Similarly, our study observed a variation of ~5% in AGD values. We suggest the radiation dose was reduced due to the regulatory body’s action over time. It follows what Oliveira et al. [17] indicated about the application of the MARP model: “This strategy promotes a collaborative approach between regulatory bodies and healthcare providers, leading to a positive impact on the quality of services and overall safety.”
The data raised transmitted by regulated facilities over the years underscore the value of dose monitoring and quality control. This large amount of data will assist in creating a national DRL in mammography program covering the national landscape of mammography settings.
This study has limitations regarding the conditions of AGD values that were obtained. These values did not consider the distribution of fibro-glandular tissue or patient data.
Conclusion
This study showed how the role of the regulatory body can promote patient safety protection and benefit in mammography facilities. The MARP method proved a valuable strategy for tracking and trending radiation doses to patients and monitoring the compliance of the normative by the mammography facility over time.
The successful experience implemented in the Santa Catarina state played as a model for national regulator ANVISA to implement the MARP/ROI methodology throughout Brazil for inspection of health services, enabling a quantitative assessment of inspections in different states. Furthermore, other countries can benefit from this method by improving regulatory actions to promote patient safety.
Conflict of interest
There is no conflict of interest.
Funding
None declared.
References
European Medicines Agency–EMA,
