Digital: Is the Technologist Ready?

OBJECTIVES:

Will copies of certificates or other documentation from the training provider suffice for the new mammographic modality training? Will accreditation continue to accept all mammography CME/CEU received? Will the mammography technologist require extra training to accredit within a digital site?

The new modalities are upon us. Are we ready? The ACR has some criteria on the subject. It usually follows that the CAR-MAP adopts most of the policies of American Accreditation so this becomes an interesting discussion.

What are examples of new mammographic modalities? What types of training would be acceptable as training in new mammographic modalities?

The term mammographic modality refers to a technology for radiography of the breast. Examples of long available mammographic modalities are screen-film mammography and Xeromammography. An example of a relatively new mammographic modality is full field digital mammography (FFDM). Personnel whose training pertained solely to screen-film mammography would be required to obtain 8 hours of training in FFDM, if they are to begin providing services or interpretations using this modality after April 28, 1999. However, if those personnel gained their experience using investigational FFDM units (units that were used for research purposes before being approved by FDA for commercial distribution), they are considered to have met the 8 hour requirement. New mammographic modality training can be in many forms, including, but not limited to, professional training, special training courses, continuing medical education, and training provided by the manufacturer.

Some personnel may receive some training in full-field digital mammography as part of their initial qualifications or have received specialized digital CME. In addition to counting toward their initial requirements, can this training also be applied to the eight hour mammographic modality training requirement?

Yes. They may use this training in digital mammography to count toward the eight hour mammographic modality training.

Can experience obtained using investigational Full Field Digital Mammography (FFDM) units count toward the 8 hour mammographic modality training requirement?

Yes; mammography technologists who began performing FFDM examinations on investigational FFDM units (units that were used for research purposes before being approved by FDA for commercial distribution), are considered to have met the requirement for 8 hours of training with that mammographic modality. However, these technologists must either attest to or document that they were providing such services. An example of acceptable documentation would be a letter from an appropriate official at the facility where the examinations were performed. Radiologic technologists who begin working with non-investigational FFDM units after April 28, 1999 must document that they had 8 hours of training in that mammographic modality before independently performing FFDM examinations. Radiologic technologists must document this training using the same methods as those used to document other training (certificates, letters from the training provider, etc.).

Are there any requirements for the content of the FFDM training and are they affected in any way by the changes in the field such as the publication of a new QA manual, FDA approval of soft copy interpretation, or the introduction of a new FFDM model by a manufacturer?

The 8 hours of initial training related to FFDM should include practical (hands-on) training in any aspects of the use of such systems such as the procedure for performing a FFDM examination and FFDM QC testing to be performed by the technologist. The remainder of the 8 hours, if any, can be didactic or practical training related to any aspect of FFDM. The instruction must be provided by a qualified instructor. Such training can also be counted towards the mammography technologist’s continuing education requirement.

FDA strongly recommends that Radiologic technologists whose 8 hours of FFDM training did not include any training in QC tests related to soft copy interpretation, obtain such practical training under a qualified instructor before beginning to independently perform such tests.

For other changes that can occur in the field, such as introduction of a new quality control manual by the manufacturer or the introduction of a new model of a FFDM unit, the same general principle as described above should be followed. If the new manual or model introduces new unique features to an FFDM system that fall into the technologist’s area of responsibility, practical training under a qualified instructor on those features should be included in the training of any technologist who has not already met the 8 hour requirement. Radiologic technologists who have previously met this requirement should also receive training in the new unique features under a qualified instructor before beginning to use them independently.

What qualifications have to be met by the individual providing the training?

The individual providing the training must be a qualified instructor. A qualified instructor is defined as an individual whose training and experience adequately prepares him or her to carry out specified training assignments. FDA recognizes Radiologic technologists who have previously met the 8 hour requirement for FFDM training as qualified to instruct other Radiologic technologists in this area.

If a mammography technologist has worked with stereotactic biopsy systems with digital image receptors before 1999. Are they considered to have met the 8 hours of training specific to FFDM?

No. Because these stereotactic biopsy systems are currently excluded from MQSA regulation, experience with these systems cannot be used to meet the requirement of 8 hours of training specific to FFDM.

I’m a Radiologic technologist and received training in current digital image receptors used for stereotactic biopsy. Can that training count toward the 8 hours of training specific to FFDM?

Training received in digital image receptors used for stereotactic biopsy after 1999 can count toward the 8 hours of training specific to FFDM if the training is essentially the same as that being given for FFDM. For example, if the technologist received training in the performance of a QC test for stereotactic digital image receptors, and the FFDM QC test is essentially the same as the stereotactic QC test; that training could count toward the 8 hours of training specific to FFDM.

What is the training requirement for a QC technologist working with digital units?

The QC technologist at a facility using a FFDM unit must be a qualified technologist who also meets the training requirement for performing FFDM examinations.

We do not have an FFDM unit at our facility; however, some of our personnel use an FFDM unit at another facility. Are we responsible for maintaining documentation showing that these people have received their initial training in the new mammographic modality?

No. Only the facility at which these personnel are actually using the FFDM unit is responsible for maintaining the documentation.

CONCLUSION:

Just because we don’t "have to" doesn’t mean we shouldn’t. It is logical to conclude that the working mammography technologist will benefit from some formal training regarding new technologies. These guidelines for preparation are sensible and within reason.

Gone are the days when our new modalities and tools are simple enough for us to master with a couple of hours applications. We will serve our patients better if we come to them well prepared. Seek the knowledge and share it.