By Thomas J. Petrone, PhD, DABR

Regulatory requirements in the medical radiation equipment and materials sector range far and wide, but one trend persists: the number of requirements and their complexity increases every year.

This increasing complexity is partly due to the introduction of new technologies and the discovery of new uses for existing technologies. A regular stream of research studies also plays a part, especially when that research reveals impacts to one of healthcare’s highest areas of concern: patient safety. Equipment that uses radiation (whether it’s produced by the machine or by the use of radiopharmaceuticals) receives extra scrutiny in regard to patient safety.

Beyond improving safety, this scrutiny also has a positive public relations benefit as it increases the trust among the general public regarding the use of radiation in medicine. Still, it can be challenging for facilities to keep pace with constant updates and the steady introduction of new regulations and requirements.

The RSO Shortage

Staying on top of regulations and other standards is where radiation safety officers (RSOs) fulfill a vital role. Naming an RSO is required as a licensing condition for any medical facility that utilizes radioactive materials for diagnosis and therapy. Yet facilities face a growing scarcity of candidates when it comes to identifying individuals who are qualified (and willing) to fill the position.

To understand why the scarcity exists, it’s important to understand an RSO’s responsibilities and who traditionally stepped into the RSO position in the past. RSOs have the authority to shut down the use of radiation equipment or to curtail the use of radiopharmaceuticals if they identify misuse or threat to patient, public, or employee safety. An RSO performs routine safety checks, signs off on equipment use, and assumes responsibility for the safety of using the equipment. In doing so, RSOs face significant pressure: They are expected to put their stamp of approval on the use of the equipment and materials, yet they often struggle to get the resources and support they need to do the job.

Hospitals typically turn to experienced nuclear medicine physicians to step into the role of an RSO. Not surprisingly, many are reluctant to do so; between the extra responsibility and the meager available support, the risk/benefit equation doesn’t look overly favorable. Meanwhile, younger physicians may not have the desire or the expertise to step into the role. It’s because of this that many hospitals and health systems are adopting or exploring the use of a “turnkey RSO” model, in which they tap outside experts to perform the RSO function and fill the void.

A Brief History

In the past, RSOs filled a more specific niche, focusing on just the oversight of the use of radiopharmaceuticals. Even then, their scope of work was determined by the amount of radiopharmaceuticals being used in a facility, types of tests and treatments performed, and whether there was research being done. An RSO in a university medical center would spend more time on such tasks than one working in a small, one-room nuclear medicine practice.

Smaller and even mid-sized facilities would often have a nuclear medicine physician authorized to use pharmaceuticals act as a “dual-role” RSO. Sometimes, a consulting medical physicist would take on the role, or at least provide support.

Even so, RSO responsibilities have expanded over the course of the last few years. This expansion is due to increased concern about radiation use in medical facilities— possibly spurred by new research surrounding CT and interventional radiology, as well as findings of over-exposures. The Joint Commission, for instance, has become more heavily involved with setting standards for facilities obtaining their accreditations (including the majority of hospitals). And new Joint Commission standards are likely to expand the RSO role even further.

Institution-specific Needs

At large facilities, especially considering the increase in regulatory requirements, RSOs are full-time employees. Even for a full-time employee, however, the job at a large institution can be overwhelming because it often includes overseeing what’s called a “broad license.” In a broad license condition, the regulatory body, whether the Nuclear Regulatory Commission or the regulatory agency of an agreement state, cedes more control to the radiation safety committee and the RSO.

In these scenarios, the RSO and the committee get to dictate what is an approved use of radiopharmaceuticals without having to check with the regulatory body or implementing a variety of constraints, as well as monitoring the situation, etc.

Small facilities don’t have the budget to appoint a full-time RSO or the amount of work to justify it, so they often just have people wearing extra hats stepping in. Mid-sized facilities may be able to squeeze an RSO salary into the budget, but as a non-revenue-generating position it’s very difficult to justify the cost. The motivation is much more stick than carrot: Costs are introduced in the form of fines when a problem is discovered (and may also arise from possible lawsuits, depending on the severity of the problem).

Even if a facility could put together the budget for the position, they might not get candidates with expertise on the equipment side, where most of the new regulations are emerging. (Radiopharmaceuticals have always been under the supervision of the RSO.)

Benefits of Outside Expertise

It’s possible to find turnkey RSO solutions that not only reduce costs, but also increase the expertise used to navigate the regulatory maze. After all, budgeting for a full-time in-house RSO might run in the range of $150,000 plus benefits—and the position doesn’t even generate revenue. An outside company that specializes in RSO turnkey solutions, however, may be able to cut that cost nearly in half due to their expertise and economy of scale.

Turnkey RSO solutions usually include trained support staff, as well—and if it’s hard for a facility to justify a full-time in-house RSO, imagine the hurdles in getting administrative support for that person. Without that support, RSOs are left to type their own notes, letters, minutes, and manuals, in addition to setting meetings, making calls, and scheduling appointments. In other words, they are their own administrative assistant—an arrangement that is less than ideal in terms of applying a specialized skill set (not to mention extremely inefficient).

Another benefit turnkey solutions have over an in-house RSO is in the area of ongoing training. For an in-house RSO, it is costly to stay abreast of the latest changes and update skills accordingly. In the case of outside providers, however, it’s costly not to keep current, since it makes them less attractive to clients.

Liability issues are another reason some may find outside providers attractive, as the turnkey solution shifts responsibility to the company providing the service under contract. Another shift of responsibility can occur regarding office politics. By having an outside expert handle the role of RSO, institutions can secure something an in-house person might find it difficult to provide: arm’s length objectivity. If a problem is found by a turnkey RSO, that is, there’s no second-guessing due to fears about offending a colleague.

Some facilities have weighed the benefits of an in-house RSO versus a turnkey and have opted for a hybrid approach. They have their in-house person, but they tap outside experts to handle certain specific modalities. These facilities recognize that it is unrealistic to expect one person with a limited budget for training to know everything there is to know.

At the end of the day, turnkey RSO solutions aren’t right for every facility. But they can be the answer for many, and the trend toward outsourcing this crucial job is only going to grow. Every hospital needs to take a long look at their needs, expenses, and exposure when it comes to radiation safety, radiation dose optimization, and equipment performance. Doing that work upfront may mean less work in the future when it comes to your RSO.

Thomas J. Petrone, PhD, DABR, is chief medical physicist and CEO of Petrone Associates. Questions and comments can be directed to chief editor Keri Forsythe-Stephens at [email protected].