Dear Dr. Z – So I’ve got a question for you…. My regulators told me that they’ll be coming by in a month or two for an inspection and said they’ll want to look over my annual program audit. First I’ve heard of this one – but, then, I’ve only been RSO for a few years and this will be my first inspection. Can you tell me what I need to and what they’ll be looking for? Thanks!
Ah – so the audit review is going around again? Yeah – this one can be a bit confusing until you’ve done a few; having said that, it’s also a requirement for the RSO to audit their radiation safety program annually, so you don’t have much choice in the matter. What you’re required to do – what your regulators are looking for – is that you review your paperwork to make sure your radiation safety program is running properly; that you can account for all of your radioactive materials, that your inspection program is effective, that you’re keeping up on your radiation dosimetry program, that you radiation workers know the stuff they’re supposed to know, and so forth. What this means in practice is that you’ll need to go through your records in each program area to make sure that you didn’t miss any regulatory requirements, that you’re not missing any records, and that any problem areas (or specific problems) have been identified and can be explained.
Take the radiation dosimetry program, for example. Regulations require that anyone who might receive 10% of their allowable radiation exposure must have a dosimeter. In addition to that, your license application might require that anybody working with mCi quantities of gamma or high-energy beta emitters must be issued a dosimeter. Your radioactive materials license might add that anybody using an irradiator or a particle accelerator is required to have a dosimeter and might also specify that these badges must be read every month, every quarter, or some other periodicity, and that the RSO will review the dosimetry reports. Plus, there’s a requirement to provide annual dosimetry reports to all workers who were issued dosimetry badges, and more.
Your annual program audit should include a checklist listing all of these requirements – your job is to check each of these items to see if your dosimetry program complies with all of these requirements. If it doesn’t then you’ll need to fix the omission (if possible), and be prepared to explain to your regulators why your requirement(s) was missed as well as what you did to fix the problem. In addition, you’ll need to make sure that nobody exceeded any of their annual exposure limits, and if anyone reached an ALARA limit (typically set at 10% and 30% of the allowable exposure limit) then you’ll also need to show that you’ve notified the radiation worker (at 10% of the limit) and investigated the radiation exposure (at 30% of the limit) and that this is documented. There’s more, of course – checking to see that declared pregnant workers were issue fetal dosimeters, confirming that everyone turned in their dosimeters each exchange period, and so forth – the bottom line is that you’ll need to go through your dosimetry program to make sure that everything was (and is being) either done properly or, for anything that was not, that these mistakes were identified, explained, and fixed. And then the same for other aspects of your radiation safety program:
- Sealed sources (inventory and leak testing)
- Training (for all new radiation workers as well as annual refresher training for everyone)
- Radioactive materials inventory (accounting for every bit of radioactive materials received, disposed of, administered to patients if you’ve got a nuclear medicine program, or decayed away)
- Inspections (if you’ve got, say, laboratories, clinics, or other groups other than radiation safety who are using radionuclides)
- Radiation-generating devices (surveys for scattered and/or leaking radiation)
- Routine surveys (contamination, radiation levels, and so forth)
- Investigations of any incidents or problems that arise (find out what happened, why it happened, actions you took to correct the incident, and changes to prevent a recurrence)
- And anything else that your regulators might be interested in!
The idea is the same for each of these – go through your regulations, your license application and license conditions, your internal policies and procedures, and any other documents relevant to your radioactive materials program and make a list of all of the requirements you need to meet…and then check to see if you’ve met them. And – always – document your results!
As far as who should perform the audit – it depends. When I was RSO at a large university and medical facility our annual audit was performed by members of our Radiation Safety Committee, with the assistance of me and my staff – it normally took a week or two (and maybe 12-18 hours of actual work). As RSO at a small licensee I performed the audit myself and it normally took about a half-day. Performing the audit in-house is a good idea as it helps you to make sure you know what’s going on with your radiation safety program. On the other hand, this can also be a recipe for complacency or can lead to taking shortcuts – for this reason it’s not a bad idea to have an outside person perform an audit every 4-5 years, to take a look at your program with “fresh eyes.” This outside audit can be performed by a consultant, by a firm that offers this service, or by any radiation safety professional with the experience to do a good audit of a program like yours. The more complex your program is, the more experience you’ll want your outside auditor to have.
The last thing you’ll want to do is to send your audit, including a summary of any issues you identified, to your supervisor or (if you have one) to the Radiation Safety Committee, as well as indicating how each of the issues you identified were resolved. This last is the part that tells your regulators that you’re actually managing a radiation safety program – if you can’t identify actual or potential problems or if you don’t take steps to fix the problems you find then they’ll be wondering if you’re managing radiation safety or if you’re simply doing a series of routine tasks without understanding why you’re doing them or how they come together into a coherent program.
Finally – I know this sounds like a lot of work – and the first time you go through it, well, it probably will be. But once you’ve done your first audit (and once you develop your audit checklist), the rest ought to be a lot easier and less confusing – and it’s a good way to know (and to demonstrate to your regulators) that you’re running your radiation safety program properly. It can be a pain in the neck – but it’s a necessary and valuable pain in the neck.
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