Current Texas X-Ray Compliance Spotlight Topic:
So, what’s all this x-ray digital imaging QA/QC?
The following is only a guide to help orient the reader. It is NOT authoritative, or comprehensive. See all applicable regulations on the Texas DSHS website for authoritative answers. Also, it was written for Dental, but the rules governing Radiographic image quality are very similar.
Does your Texas dental practice use dental x-ray “sensors”, “phosphor plates”, digital panoramic, and/or 3D CBCT x-ray equipment to image your x-rays? Then the Texas DSHS requires you to have QA/QC procedures/ processes/ protocols and records. You are to implement these procedures at defined intervals and record your results. An Image QA/QC procedure is a means to measure the performance of the part of your x-ray system that receives the x-rays and converts these x-rays into images. Then you verify that this performance has not degraded below acceptable limits. Digital imaging QA/QC is required by regulations because digital imaging systems are designed to be reused over and over, which gives opportunity for wear, degradation, and partial failure.
Back in the day, x-ray images were made on film, and developed in chemicals in a darkroom or film-processor. Regulations have long required x-ray film users maintain QA/QC on their films, chemicals, and darkrooms, to prevent poor x-ray images that cause excessive x-ray exposure and re-takes. The Texas regulations for film-based x-ray QA/QC are fairly specific, and come complete with nifty example forms to help dental practices maintain regulatory compliance.
Nowadays, most dental practices use digital x-ray image systems, instead of film. The Texas §289.232(i)(16) regulations for digital x-ray imaging QA/QC (below) say to use the manufacturer’s QA procedures, if they are available. If these are not available, then you must establish your own QA procedures. No example procedures or forms are provided by the state, and manufacturer QA procedures are often difficult or impossible to find. If you do find them, you will usually also need to obtain specialized ( and expensive) phantoms, software, passwords, etc. Even if you acquire these extras, they will typically only be compatible with one model of system. But, the main advantage of manufacturer QA procedures is that they typically yield specific pass-fail results, whereas the results of general QA testing process will need to be interpreted.
If lacking manufacturer QA resources, you can establish your own QA procedures, but digital x-ray imaging QA is a fairly technical endeavor and certainly not taught in dental schools. Because of this, one of the most efficient means to achieve digital imaging QA compliance is to simply hire a service. Our QA phantom, procedures, and forms are well tested and based on industry-standards. If you are in the central or eastern part of Texas, we can come to your site, perform the measurements, fill-out the records, and discuss the QA findings with you. This generally improves the QA/QC consistency and the reliability of staying in compliance.
What is typically involved in image quality QA/QC testing?
Typical elements of digital x-ray imaging QA/QC procedures and phantoms:
• A QA phantom and procedures to acquire standardized x-ray images. These procedures must
also include the ability to maintain radiation safety practices.
• Procedures for assessing these QA images to determine the limits of the performance of your
digital x-ray image receptors. Also to assess any defects or image artifacts.
• Procedures which create records that conform to the regulatory requirements and industry
standards. These records should include: unique identifiers for all the images and systems
assessed, equipment utilized and its settings, dates, initials, QA intervals, etc.
• Procedures to compare against past assessments to detect degradation over time.
• Procedures to escalate suspected image quality issues.
The specific Texas dental digital x-ray imaging QA regulations
(from: https://www.dshs.texas.gov/radiation/laws-rules.aspx )
§289.232(i)(16) Digital imaging acquisition systems. Users of digital imaging acquisition systems shall follow quality assurance/quality control protocol for image processing established by the manufacturer or, if no manufacturer's protocol is available, by the registrant. The registrant shall include the protocols, whether established by the registrant or the manufacturer, in its operating and safety procedures. The registrant shall document the frequency at which the quality assurance / quality control protocol is performed. Documentation shall include the date and initials of the individual completing the document and shall be maintained at the site where performed in accordance with subsection (k)(1)(X)(i) of this section for inspection by the agency.
The state’s “summary” of the above section states:
“If you have a digital imaging system, follow the instructions for quality assurance/quality control provided by the manufacturer. However, if the manufacturer does not provide instructions, then you must develop your own. You must keep the instructions in your operating and safety procedures.”
Resources available from The Texas DSHS:
https://www.dshs.texas.gov/radiation/laws-rules.aspx
https://www.dshs.texas.gov/radiation/x-ray/regulatory-guides.aspx