A consensus-based, process commissioning template for high-dose-rate gynecologic treatments

Abstract

Purpose

There is a lack of prescriptive, practical information for those doing the work of commissioning high-dose-rate (HDR) gynecologic (GYN) treatment equipment. The purpose of this work is to develop a vendor-neutral, consensus-based, commissioning template to improve standardization of the commissioning process.

Methods and Materials

A series of commissioning procedures and tests specific to HDR GYN treatments were compiled within one institution. The list of procedures and tests was then sent to five external reviewers at clinics engaged in HDR GYN treatments. External reviewers were asked to (1) suggest deletions, additions, and improvements/modifications to descriptions, (2) link the procedures and tests to common, severe failure modes based on their effectiveness at mitigating those failure modes, and (3) rank the procedures and tests based on perceived level of importance.

Results

External reviewers suggested the addition of 14 procedures and tests. The final template consists of 67 procedures and tests. “Treatment process” and “staff training” sections were identified as mitigating the highest number of commonly reported failure modes. The mean perceived importance for all procedures and tests was 4.4 of 5, and the mean for each section ranged from 3.6 to 4.8. Sections of the template that were identified as mitigating the highest number of commonly reported failure modes were not assigned the highest perceived importance.

Conclusion

The commissioning template developed here provides a standardized approach to process and equipment commissioning. The discord between perceived importance and mitigation of the highest number of failure modes suggests that increased focus should be placed on procedures and tests in “treatment process” and “staff training” sections.

Introduction

Worldwide, cervical cancer is the fourth most common cancer in women and the second leading cause of cancer death in women, with 85% of the global burden occurring in less developed regions (1). Brachytherapy is a crucial part of the effective treatment of locally advanced cervical cancer and other gynecologic malignancies. A patterns of care study by Han et al. (2) concluded that “Brachytherapy use is independently associated with significantly higher cause-specific survival and overall survival and should be implemented in all feasible cases.” In addition, a recent editorial in the Red Journal was pointedly titled “Curative radiation therapy for locally advanced cervical cancer: brachytherapy is NOT optional” (3). These studies, combined with cervical cancer incidence statistics and the global effort to provide improved access to radiation therapy (4), mean that, at least globally, numerous high-dose-rate (HDR) gynecologic (GYN) brachytherapy programs are likely to be established in the coming years (even if brachytherapy use in the United States continues to decrease). It is also likely, and unfortunate, that each of these new programs will have to design and implement their own commissioning plan. This duplication of work is not only wasteful, it is potentially dangerous since important steps in the commissioning process may be missed or forgotten. The purpose of the current work is to fill the void in published, practical guidance on commissioning an HDR GYN brachytherapy program.

This is not to say that guidance for HDR brachytherapy does not exist in the literature. In fact, there is an abundance of very well-written, well-thought-out articles on HDR treatment process and quality assurance. While useful, none of these offer a practical, prescriptive approach to the process of commissioning an HDR unit for the treatment of GYN malignancies [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16], [17]. This is despite a publication by Thomadsen et al. (12) that lists “Commissioning of the treatment unit, treatment planning system and each new source…” second in a list that describes “Key measures to avoid catastrophic failures” in HDR brachytherapy.

With the goal of reducing workload and standardizing the process of commissioning an HDR unit for GYN treatments, we have developed a simple, practical commissioning template. Although many of the procedures and tests presented in the template could be equally well applied to commissioning for other types of HDR brachytherapy, we have chose to focus our efforts on GYN treatments. Every effort has been made to ensure that the procedures and tests presented in the commissioning template are both vendor and isotope (¹⁹²Ir vs. ⁶⁰Co) neutral. Descriptions of procedures and tests are designed to be sufficiently detailed to allow the user of the tool to understand what is required, but generic enough that vendor-specific detail is not required. In an effort to facilitate the use of the tool and offer some guidance on the general utility of each procedure and test, a commissioning template and description of each of the procedures and tests is included in the appendices.

To demonstrate/validate the utility of each of the procedures and tests, expert reviewers were asked to rate the perceived importance of each procedure and test on a scale of 1–5 and to link procedures and tests to commonly reported or hypothesized severe failure modes. The list of failure modes used in for this purpose was derived from the reviews by Thomadsen et al. (18) and Richardson (19) of HDR incidents and the prospective hazard analysis by Wilkinson et al. (20). A summary of these failure modes, and the failure mode categorization used in the current work, is presented in Table 1.