History of clinical auditing for radiology and its evolution to B-QUAADRIL for Belgium

By Tom Van Herpe¹ & Jan Schillebeeckx²

History of clinical auditing

Medical imaging has accelerated the enormous progress in medicine. The number of radiological examinations has increased dramatically the last decades and, therefore, is currently standard daily practice. It can be expected this number will even continue to grow due to the rising average population age and the enhanced treatments (chronic illnesses in particular).  Despite many technical improvements, diagnostic radiology is still known for its large number of detection errors (Revesz and Kundel, 1997; Birdwell et al. 2001; Stephen Waite et al., 2017) and more attention is paid to the quality management of medical imaging examinations. Worldwide there has been a tendency to establish quality systems and introduce appropriate quality audits. However, the concept of clinical audit is not new and has long been applied in other fields of health care, e.g. surgery (Williams 1996; Tabish, 2001; Shaw 2003).

In 1997, the Council Directive 97/43/EURATOM introduced the concept of clinical auditing for medical radiological procedures. This directive aimed at, on the one hand, avoiding unnecessary or excessive exposure to radiation and, on the other hand, improving the quality and effectiveness of the medical use of radiation (Sarro Vaquero, 2003). In 2003, the first International Symposium of Clinical Audit in Tampere (Finland) made clear that the variation of implementing the directive among the member states was rather high (Soimakallio et al., 2003). Some countries applied a systematic approach (regular internal/external clinical audits) whereas an appropriate audit structure was missing for the majority of the countries. The unavailability of an auditing framework and the missing standards or criteria turned out to be the most indicated reasons for the poor success of implementing the aforementioned directive.

As a reaction, the International Atomic Energy Agency (IAEA) started preparing a guidance framework for external clinical audit of radiotherapy and radiology departments. This work resulted in the publication of the QUAADRIL (Quality Assurance Audit for Diagnostic Improvement and Learning, 2010) document which is endorsed by several national and international radiological organizations. In 2013, the Council Directive 2013/122/Euratom described the basic safety standards for the protection against the dangers arising from exposure to ionising radiation. Furthermore, the directive mentions that all member states are responsible to carry out the clinical audits according to their national procedures.

For Belgium, it was BELMIP (Belgian Medical Imaging Platform) and FPS Health (Federal Public Service Health) that decided to convert QUAADRIL to B-QUAADRIL by selecting the elementary aspects most relevant for Belgian radiological services. The final version was published in July 2019. Prior to this, pilots were carried out in several hospital radiology departments, private radiology practices and non-radiology specialist practices in order to validate the procedures of clinical audit. Starting September 1, 2019 clinical audits (according to the B-QUAADRIL regulations) are now officially mandatory.

At least one B-QUAADRIL audit every two years is required. Different phases are foreseen, ranging from a self-assessment (i.e. organized by the radiology department itself), over an internal audit (i.e. organized within the organisation) to an external audit (organized outside the organization). Currently, the self-evaluation phase is already being carried out, meaning that all Belgian radiological services using ionizing radiation are expected to have started assessing their activities using the B-QUAADRIL manual. It can be expected that the type of audit will evolve to the other phases in the future.

The B-QUAADRIL questionnaire comprises three different levels of quality. Level A questions are related to standards that are required by, for example, law or technical lAEA publications whereas Level B questions are expected to be met by all radiological services that wish to attain the highest levels of quality (though not officially mandatory). The last category consists of supplementary standards (in particular relevant for educational and/or scientific research centres). If certain criteria are not fulfilled, the appropriate actions need to be undertaken. Depending on the quality level, the sense of urgency differs. Shortcomings against level A criteria must be accomplished (very) urgently whereas corrective actions against level B are just strongly recommended. Finally, level C standards (though not being essential) will improve the general working of the radiology department.

COMPLIANCE solution

QAELUM has recently presented COMPLIANCE as a new online application with B-QUAADRIL as an initial standard. The COMPLIANCE – B-QUAADRIL software has the aim to facilitate the process of self-evaluating a radiological service. All levels A, B and C criteria are placed in order and the current status (answering each question) can be digitally and individually assigned (including automatically stored, individual time stamps). Moreover, proofs (in the format of documents or procedures) can be easily uploaded per criterion. Figure 1 presents a screenshot of how answers can be submitted per criterion: status (using a tick box system), proofs (to be uploaded from a computer or server), and the possibility to add free text (to specify or to comment).

Figure 1: Answering questions

The software clearly indicates which criterions have not been addressed yet and allows to generate smart progress overviews at any point in time. Follow-up of potential shortcomings forms a crucial factor in a qualitative clinical audit. Therefore, an action plan (per category) can be easily compiled in the software, and priority levels can be assigned (using a tick box system). It is important when evaluating/auditing departmental processes that improvement or progress can be expected. The B-QUAADRIL action plan allows specific criteria to be fulfilled as it requires “tangible” actions.

Following the B-QUAADRIL standard the self-evaluation phase should be repeated at least every two years. Indeed, evaluating and auditing a radiological service must be approached as a continuous process rather than a ‘single-shot’. The B-QUAADRIL software freezes the results when finishing a clinical self-evaluation phase, will use previously-stored versions as a starting position (for the next upcoming self-evaluation/audit phase) and presents the trends on how the different criterions were met throughout the time.

Finally, B-QUAADRIL has the ability to automatically generate reports showing the individual response for each question, the progress while evaluating (overall and at specified levels), the action plan and predefined analytics. It is mandatory for each radiology department in Belgium to apply the B-QUAADRIL clinical audit program and to generate self-evaluation reports as presented here (Figure 2).

Figure 2: Example report

The concept of clinical audits applied in the field of radiology is nothing new but has received more concrete attention since the publication of the European Directive in 2013. More specifically for Belgium, the B-QUAADRIL standard has become the official framework used to evaluate and to optimize the quality within all radiological services using ionizing radiation. As suggested by FANC/AFCN (Belgian Federal Agency for Nuclear Control), software could help to adequately register the information and to easily follow-up on improvement points.

The company QAELUM, having huge experience as medical software provider for radiology, now presents a new software product (COMPLIANCE) having one branch specifically tailored to the B-QUAADRIL standard. It will be possible for radiology departments to make a “quick-start” when performing a B-QUAADRIL self-evaluation. Time will be saved and workload (e.g. for quality managers) will be reduced. It will be possible to generate reports, according to the B-QUAADRIL format, expressing the performance degree of the individual criterions, trends and the improvement actions. In conclusion, COMPLIANCE - B-QUAADRIL is a guide to the whole Belgian radiological field and enables and encourages the further improvement of health care quality.

More about COMPLIANCE B-QUAADRIL

References

• Revesz G. and Kundel H.L. Psychophysical studies of detection errors in chest radiology, Radiology 1997; 123; 559-562
• Birdwell R.L., Ikeda D.M., O’Shaughnessy K.F. and SicklesE.A., Mammographical Characteristics of 115 Missed Cancers Later Detected with Screening Mammography and the Potential Utility of Computer aided Detection, Radiology 2001; 219; 192-202.
• Stephen Waite, Jinel Scott, Brian Gale, Travis Fuchs; Interpretive Error in Radiology, AJR April 2017
• Williams O. (1996). What is clinical audit? J R Coll Surg Eng 78; 406-411.
• Tabish S.A. Clinical audit, JK-Practitioner 2001; 8(4); 270-275
• Shaw CD. External quality mechanisms for health care: summary of ExPeRT Project on visitatie, accreditation, EFQM and ISO assessment In European Union countries, Int. J.
• Sarro Vaquero, Mercedes. Introduction to Clinical Audit, Proceedings of the International Symposium on Practical Implementation of Clinical audit for Exposure to Radiation in Medical Practices, Tampere 24-27 May, 2003.
• Soimakallio S., Järvinen H, Kortelainen K. Proceedings of the International Symposium on Practical Implementation of Clinical audit for Exposure to Radiation in Medical Practices, Tampere 24-27 May, 2003; see clinicalaudit.net.

Disclosure statement

1. Tom Van Herpe, Ph.D.: R&D Project Manager focusing on medical devices in multiple clinical fields (intensive care, diabetes, radiology), currently working for Qaelum as a senior researcher.

2. Jan Schillebeeckx: Currently healthcare consultant, especially process improvement, workflow optimization and clinical audits in radiology departments: interventions in several hospital groups worldwide. Past chairman of the department of Medical Imaging at the Imelda Hospital, Bonheiden, Belgium from 1983 till 2006. Consultant radiologist in that hospital till July 31, 2013. (Retirement)