Identifying and Mitigating Hazards in Radiation Therapy

• 1/29/2010
• Author: Steven Berman
• Category: The Journal Blog
• 17075 Views
• 0 Comments
• 

2:22:04 PM

This week, I asked Kurt R. Herzer, Marshall Scholar, University of Oxford, and Woodrow Wilson Research Fellow, Johns Hopkins University, to guest on the Journal blog. Mr. Herzer comments on two recent investigative articles in the New York Times reporting on the incidence and impact of rare accidents in radiation therapy, many of which can cause irreversible patient harm and even death (http://www.nytimes.com/2010/01/24/health/24radiation.html; http://www.nytimes.com/2010/01/27/us/27radiation.html?ref=health. Mr. Herzer was the lead author of “A practical framework for patient care teams to prospectively identify and mitigate clinical hazards,” which appeared in the February 2009 issue. Mr. Herzer welcomes your  comments.

As the scope and possibilities of radiation treatment expand, so too should our attention to delivering it safely. With more than 50% of American cancer patients receiving some form of radiation therapy and the average lifetime dose of diagnostic radiation seven-fold what it was 30 years ago, systems must exist to manage the complexity introduced by these new life-saving treatments.

The New York Times articles articulate the debilitating consequences of errors in radiation treatment through several patient stories. The patients suffering this undue harm experienced severe and unremitting pain, burns, deafness, visual impairment, loss of the ability to swallow, and death. Although these severe and regrettable cases might be rare, the factors that precipitated the hazards that led to them may be common.

James Reason’s model of error causation provides a useful conceptual model for understanding how clinical hazards emerge and lead to patient harm. Active failures are short-lived but can have a direct impact on the resilience of system defenses. They are often the result of unsafe acts committed by providers. Latent failures, in contrast, arise from organizational culture, policies, and management decisions and can lead to error-prone conditions in the work environment or have a long-term crippling effect on system defenses. Indeed, the New York Times investigation found that in the case of radiation, “software flaws, faulty programming, poor safety procedures, or inadequate staffing and training” could be sources of error.

The New York Times articles also raise several pertinent questions. How do hospitals, patient care teams, and individual clinicians manage the potential hazards created by the influx of technological innovation? Is reading a manual or going through limited training in the use of the devise or therapy enough? What is the best way to train residents and students in the use of these technologies? With a theory like Reason’s in mind, an approach is needed that is both rigorous in indentifying and mitigating hazards before patients are harmed and feasible for bustling hospitals and busy clinicians to use.

Our article in the Journal described a framework to prospectively identify and mitigate hazards that met both these criteria. This framework includes a background investigation and literature search; an in situ simulation (in the actual clinical setting used for patients); a Failure Mode and Effects Analysis to determine the severity, probability, and risk of the potential hazards; the correction or elimination of the hazards; and a multidisciplinary protocol and safety checklist to standardize practice and ensure provider accountability. All these steps are described in detail in the Journal article.

Bridging theory and practice, we applied this framework through three case examples, one of which was intraoperative radiation therapy (IORT). IORT involves delivering localized, high-dose-rate radiation to a tumor or tumor bed during a surgical procedure, requiring specialized brachytherapy equipment and a specialized shielded operating room (OR).  In introducing IORT to our institution for the first time, we used this framework to uncover unknown hazards before patients could receive the therapy. A human simulator was used for the in situ simulations, which were conducted in the same OR we would use for all of our patients, and real radiation was applied and measured. The simulation identified 20 potential hazards in the patient care process, some serious enough to substantially harm or kill a patient should they occur. These included such problems as the calibration of OR radiation meters, fixing the OR door to avoid radiation leaks, developing ways to remotely manage anesthesia, and standardizing language that was clear for both the clinicians and physicists participating in IORT cases. After all hazards were mitigated, and a multispecialty protocol and checklist were developed for IORT cases, patients were admitted to receive the surgical procedure and the therapy. Since its inception, nearly 30 patients have received IORT, and there have been no incidents, adverse events, or errors, and the protocol and safety procedures developed using this framework were consistently used for every case. This package model can be widely adapted by other institutions for the safe delivery of radiological procedures.

While this approach may be useful at a hospital level for protecting patients, at the macro level creating transparency in the problems associated with radiation treatment by reporting and monitoring incidents can help create a shared learning community for hospitals and radiation specialists to learn from one another. Achieving this will require vision, creativity, and collaboration. My colleagues and I look forward to the discussion that ensues.