DBT and Modality Training Requirements Clarified
By Bonnie Rush, RT(R)(M)(QM)
A minimum of 8 hours of modality related training – particular to the mammographic modality to be used – has always been part of the initial mammography training requirements for the mammography technologist, the interpreting physician, or the medical physicist. This was simple when we had only xerography and screen-film as our initial modality. Most xerography units were put out of use at the time of the Mammography Quality Standards Act and Program (MQSA).
With the advent of 2D full field digital mammography (FFDM), the MQSA added the requirement that all personnel involved in FFDM imaging receive a minimum of 8 hours of digital modality training; thus many technologists had both screen-film and digital training. Now screen-film is disappearing, and many sites are implementing 3D digital breast tomosynthesis (DBT). This new modality training remained simple when there was only one type of DBT unit from Hologic, approved in February 2011. Now we have also a DBT unit from GE, which was approved in August of 2014.
This has complicated the new modality training due to the differences in systems approaches by each manufacturer. A memo was circulated to MQSA inspectors on March 18 from the Division of Mammography Quality Standards (DMQS) to help clarify modality related training.
The memo indicates: “Due to the technological differences between the DBT units, as well as their different FDA-approved Indications for Use (IFU), each manufacturer’s DBT system is currently a new mammographic modality.”
Previously, digital training could have been provided by a general training course, but this type of training is no longer sufficient for DBT. If personnel received 8 hours of training on DBT as a modality but it was not specific to their unit, they must prove training on the unique features of the specific manufacturer’s DBT system before beginning to independently use that system. This would also apply if they had been trained on one type of DBT unit and began to work with a different type of DBT unit. The training in the unique features of the particular DBT system used may be included in the 8 hours of new-modality training, or this training in the unique features may be obtained separately.
As to the appropriate training documentation, the inspector “will accept a course certificate or letter that clearly indicates the training included the unique features of the particular system, or a signed attestation using DMQS’s recommended form or a form with similar elements, to document training in the unique features.”
If 8 hours of Hologic new-modality training in DBT were obtained when Hologic was the only approved DBT system (prior to August of 2014), and the individual is only using the Hologic system, the training certificate received would be adequate and does not have to state the specifics of the particular system were included.
Bonnie Rush, RT(R)(M)(QM), President of Breast Imaging Specialists (www.mammobis.org), and author of the MQSA Made Easy manual. She is the AHRA liaison to Are You Dense Advocacy, Inc. and can be reached at firstname.lastname@example.org.
For more regulatory news, visit www.ahraonline.org/news.