NJ CBCT Regulation FAQ & Assistance According to the State of New Jersey Department of Environmental Protection, all dental CBCT facilities must implement the NJDA alternative QA program by June 30 th, 2014. Q: Do you have the NJDA requirements available? A: Yes, please visit - http://www.state.nj.us/dep/rpp/cbct_qa/reg_letter_dental_cbct.pdf New Law related questions Q: Which units are affected by these requirements? A: Kodak 9500, Kodak 9000 3D, Kodak 9000C 3D, CS 9000 3D, CS 9000C 3D, CS 9300-1, CS 9300, CS 9300C, CS 9300 Select, CS 9300C Select, and CS 8100 3D Q: Are other 3D units affected by this law? A: All CBCT systems operated by dental professionals must comply with these regulations. Q: Are there any other states enforcing similar regulations? A: Presently, NJ is the pioneer for enforcing a specific quality assurance program for CBCT units. Q: Why is a quality assurance program necessary for CBCT? A: Dental CBCT machines are very complex radiology systems. The Quality Assurance procedure ensures that the system is working at a standard level of efficiency. Should any variance for that standard occur, then corrective actions can be requested. Q: Why is a quality assurance process being requested now? A: Strict quality assurance rules have been in place for many years in the medical space for CT imaging. Cone Beam is a new technology that has emerged just recently within the dental space. Cone Beam differs from fan beam technology (Medical CT), and it has taken time to define a legal framework that can be applied to cone beam.
Q: How does the IAC (Intersocietal Accreditation Commission) accreditation compares with this new law? A: The IAC accreditation proposes a totally different topic. This is not a legal QA process. This is meant to enroll into health reimbursement programs. Being compliant with the new NJ Requirements does NOT mean being IAC accredited and vice versa. Quality Assurance (QA) procedure related questions Q: What does the QA consists of? A: The QA consist of performing frequent tests to monitor the performances of the system. These tests are divided into two categories: daily and annually. The daily test must be performed by a certified person every day before using the Dental CBCT system. The annual test must be performed by a NJ registered physicist. Q: What do I need to perform the QAT process and why is a QAT phantom needed? A: A specific QA phantom has been developed, and must be used with the Calibration Tool software that directs the operator step-by-step through the test procedure and records all information in a Quality Assurance Journal. Q: An approved NJ medical physicist will need to perform the initial & annual QA tests according to the requirements. Where can I search for an approved physicist? A: You can search for an approved NJ medical physicist from the link below. We recommend asking if the medical physicist is approved for CT testing and has additional experience in CBCT QA testing. http://datamine2.state.nj.us/dep_opra/opramain/categories?category=medical+physicists Q: How much time of our day should we set aside for performing the daily QAT requirement? A: 5 10 minutes. It is recommended you perform the QAT first thing in the morning.
Q: If I need assistance with the QAT process, who should I contact? A: Call Imaging Technical Solutions and Service Center 1-866-724-6317 press 2 and then 1 for QAT assistance Hours - Mon-Thurs: 8am - 10pm ET, Fri: 8am - 9pm ET **Reps Please email jonathan.cox@carestream.com or nina.wilson@carestream.com with any questions that are not within the FAQ. We will actively update the FAQ with new incoming questions. Thank You** Compliance related questions Q: How can Carestream help my practice comply with these requirements? A: Depending on your needs, 3 kits have been created that include the phantom only, up to the complete user training and software updates that may be necessary. Q: How much do the compliance kits cost? A: This will depend on your current configuration. Please call your Carestream Dental customer service representative at: (770) 226-3684 Training/Certification related questions Q: Who can be trained and certified to use my CBCT system? A: A licensed dentist, a licensed dental radiologic technologist, or a registered dental hygienist can use a CBCT system provided that they have received the necessary training for scan protocols and equipment operation by the manufacturer. Q: Who can train who? A: The manufacturer can train the licensed dentists, licensed dental radiologic technologists, and registered dental hygienists. Once trained by the manufacturer, the licensed dentist can train the licensed dental radiologic technologists and registered dental hygienists.
Q: I need a proof of training from the manufacturer. How can I get it? A: If you have been trained by Carestream Dental after having your system installed, we can send you the Training Record we have available. Please call 1-800-230-3425 and dial option 1 to request a call back. You can use your current Masterworks Learning Center account to access the full training package. If the training is not visible in your account, please contact masterworksonline@carestream.com to request the training be provided. Once you complete the training, we can then provide a certificate of completion. Q: Is the radiation safety training necessary for NJ requirements? A: It is not compulsory, but a bonus feature of the Standard and Complete kits is to increase knowledge in ALARA (As Low As Reasonably Achievable) principles, which falls under the regulatory realm. Training is composed of three, 1 hour sessions for which a certificate of completion is delivered after all sessions have been completed. Q: How long will the CBCT complete user training course take to finish? A: The online course will take 4 hours approximately. Q: How many staff members should be certified to use my CBCT system? A: We advise that at least two staff members be certified to prevent any down time of the system should an operator not be available. CBCT system related questions Q: Will my system be compatible with the new QA procedure? A: Depending on the age of your system, it may require some software updates to get to the level of requirement of the new QA protocol. As a matter of fact, all systems have been designed for some kind of QA testing, but this was meant to be done by qualified technicians at installation time and during maintenance procedures. There was no need of keeping record of the test result.
Q: My system is no longer under a warranty plan. What are my options? A: Depending on the age of your system and the version of your Imaging/Practice Management Software, newer versions may be required. We have created a specific update offer that includes 90 days coverage so you can have your system updated to the latest version. Please contact your Carestream Dental customer service representative at: (770) 226-3684