I have been in practice for more than 25 years and have never heard of this and am sure my machines aren't inspected. Do I have to have this done? Effective January 1, 2014, it is the responsibility of the owner of x-ray machines to provide for both initial and periodic inspection of x-ray machines, and to ensure radiation shielding is adequate, through use of MRCP-approved Qualified Experts (QEs) in radiation safety. Therefore, you should contact the MRCP to register your location and numbers/types of machines. This registration will result in a Qualified Expert needing to visit your location (at your cots) to have the machines inspected. If you have a CBCT it will be every three years; for all other machines, it will be every six years.
As far as I know my office has never had an inspection done, but I have only been sole owner for three years and just this week was the first I had ever heard of this requirement. Do I need to go ahead and have the inspection done or do I wait until I get notice of the survey inspection being due? I have a Sirona XG3D cone beam, a Nomad and two wall-mounted arms. In this situation, the dentist was unaware that cone beams need to be inspected every year and in speaking with the state, the MRCP did not show him as having a cone beam registered to his office. We also ascertained his other inspections are not due until 2019. Therefore, he needs to immediately register the CBCT with the state, according to 19 CSR 20-10.030(2) “The user shall notify the department in writing within 30 days of any change with respect to his/her radiation sources which may substantially increase or decrease the potential for exposure” and schedule an inspection of that machine ASAP (for CBCT this is a Class A machine and should be prior to clinical usage), but in any case, within 90 days of the notification. Although the dentist could go ahead with inspections of all his machines, including those not due until 2019, it may behoove him to wait, since he will need to have an annual inspection by a QE of his CBCT.
In this last scenario, one could ask “What if, in 2019, the doctor’s CBCT is due in January and his other machines aren’t due until September of that year? Can he have them all done at the same time, even though his due dates are different? Yes. There is no penalty for having the regular (non CBCT) inspections done early. The MRCP will reset the doctor’s other machines to be the same month as the CBCT.
In a related question, suppose I work with some other practices and we arrange for a QE to come do all our inspections within a day, because we’ll be given a “bulk” discount. What if we all have inspection dates in the same year but different months? Can we have our inspections done at the same time so that we can experience the discount from the QE? Yes. The MRCP will give bonus time (up to 12 months from the next due date) if doctors get the inspection done early. Therefore, if one is due in January and one is September, and the QE comes in January, the doctor with the September date can get their inspection early but their actual 6-year cycle will not begin until their original September date. You cannot be past your inspection due date but you can be early and use the bonus time to your benefit – to possibly group with other areas dentists and negotiate a reduced fee for inspection services from the QE.
If I have a new radiation machine installed at my office, who is responsible for registering it with the state? Me or the installer (such as Goetze or Patterson)? The dentist is always responsible to ensure it gets registered with the state. The MRCP has created a guidance document specifically designed for service reps to hand out to dental facilities that are just opening up or adding additional (+1) machines. This is because MRCP finds a lot of confusion when they contact facilities and tell them they need to either complete a registration or have a QE inspection, at which time they commonly report “the service company told me they took care of all the paperwork.” The service company DOES send MRCP a form of new installs or major repairs, but that doesn’t replace the facility’s responsibility to update its registration with MRCP or get new rooms inspected!
If you have a machine that was manufactured after 1977, then it must be installed by a “certified” professional. That certified installed is responsible for notifying the state of their installation, at which point the state can contact the dentist to verify the install. However, some vendors are slow to submit their paperwork, with a delay of as much as 3-6 months. Additionally, sometimes a certified installer is not used and someone like an electrician may install a machine and may not submit the proper paperwork (which in itself is a violation of federal FDA regulations). Therefore, a dentist should always ensure the MRCP is notified.
There are two scenarios/ways to notify the MRCP: 1) If it is a radiation machine that is replacing another, the dentist simply needs to call the MRCP to let them know which machine is being replaced within 30 days; no inspection needs to occur. 2) If it is a new radiation machine being installed in addition to others already existing in the practice, then … “The user shall notify the department in writing within 30 days of any change with respect to his/her radiation sources which may substantially increase or decrease the potential for exposure.” 19 CSR 20-10.030(2) … and should have an inspection (ideally) prior to routine clinical usage (practically) within 90 days from installation.
I know my inspection date is 2018 for my existing units, but I am getting a new one installed next week. Does the new one require an inspection and if so, should I do all the inspections at the same time or just the new one and wait until the actual due date for the others? See above. If it is merely a replacement in an existing x-ray room/operatory, you should notify the MRCP and can wait to have it inspected with the other machines. If it is a “plus 1” machine – an additional machine to your existing inventory – you should notify the MRCP within 30 days and have it inspected no later than 90 days after installation because of the additional radiation exposure in the practice.
I have three different practice locations and all three have different inspection due dates. Can I have them done all at the same time so that future inspection dates are synchronized? Yes, you can contact the MRCP and ask them about synchronizing your various office inspection dates.
Follow-up with MRCP Program
In the Spring 2017, the MDA followed up with John Langston, Bureau Administrator of the MRCP, on some additional questions since publishing this web page. Those questions and responses follow. You can find these and other FAQs on the MDA page and on the FAQ section of the MRCP.
Has the MDA’s effort to inform members resulted in calls to you with questions/concerns that you want to expose or allay? We get a fair number of questions, but most of them are specific to a given facility. The questions are nuanced, thus there has not been one big question. The answers to most general radiation safety questions can be found on the FAQ section of our website.
What, if anything, are the QE reports telling you? Are most machines where they need to be in terms of safety? Is there anything to learn from these reports, collectively? Because each QE can (within limits) use their own inspection forms, it’s difficult to get too far down in the weeds as far as specific details. However, based on the mandated summary data in a specific format that the QEs send the MRCP, I can give you some overall aggregate data for dental inspections conducted from January 1, 2014 through December 31, 2016 (the past two years). Something important to keep in mind: Routine QE inspections of existing dental facilities (that were already there prior to 1/1/14) did not routinely start until 1/1/2017. So the inspection results we have so far are primarily for newly installed equipment (new facilities), facilities that have relocated/moved, and CBCT facilities. Therefore, in most cases, these are facilities where the equipment tends to be installed more recently. Once the older equipment is inspected, there may be an uptick in findings that require corrective action.
CLASS D DENTAL (INTRA/ORAL & ROUTINE PANO EQUIPMENT)
341 inspections between 1/1/14–12/31/16
Grade 0 (no items of note, nothing to correct): 279 (82%)
Grade 1 (minor findings, suggested corrections [not mandated]): 47 (14%)
Grade 2 (significant findings, corrective action/service required w/in 30 days): 14 (4%)
Grade 3 (unsafe conditions, cease use immediately until corrected): 1 (<1%)
CLASS A DENTAL (CBCT EQUIPMENT)
409 inspections between 1/1/14–12/31/16
Grade 0 (no items of note, nothing to correct): 324 (79%)
Grade 1 (minor findings, suggested corrections [not mandated]): 66 (16%)
Grade 2 (significant findings, corrective action/service required w/in 30 days): 17 (4%)
Grade 3 (unsafe conditions, cease use immediately until corrected): 2 (<1%)
A dentist contacted us who is replacing a pano with a cone beam. He wanted to know if there were regulations regarding if it had to be in its own walled-off room? That speaks to overall questions about shielding that we get from a lot of facilities, dental included. We will get cold calls from facilities or vendors with a quick question “how much shielding do I need, or do I need anything?” That’s just not a question that has a quick answer other than “it depends.” Dental facilities need less additional shielding than most other facility types, but it’s still dependent on the number of machines, the location, the workload, the type of machines and their typical settings, etc. QEs can spend a lot of time trying to accurately calculate the proper amount of shielding. As noted on the information we sent back in 2014, our rules refer back to and require compliance with NCRP Report No. 145 Radiation Protection in Dentistry (which is the process of being revised). It’s a 190-page document that describes everything QEs (and facilities) need to take into account from a radiation safety standpoint, and it’s a large part of what a QE may refer to during inspections. For dental offices, the short story is, many (even most) won’t, but some will require additional shielding.