Today we’re dealing with a confusing topic with significant clinical, technical and legal ramifications. Specific retention requirements—like screening conventions themselves—vary widely by country as well as locally at the province/state level.
In general, retention of prior film and digital images falls into two very different camps: one puts responsibility on the healthcare facility to retain the images and make them available for a set number of years. Countries such as the U.S., Canada and many European countries mandate this. The other places the onus on the woman being screened to store and retrieve prior images, as in Mexico, South America and India.
For this discussion, we’ll focus on U.S. requirements since they are among the more confusing. For starters, U.S. facilities providing mammography must follow the Mammography Quality Standards Act (MQSA). This law mandates that mammograms be retained for a period of not less than five years and, in some cases, at least 10 years if no additional mammograms of the patient are performed at the facility. But remember, individual state laws may require even longer retention and are equally important to follow.
Many facilities end up retaining prior films for the life of the patient (or longer). This might be due to litigation concerns that could result from missed cancers, lack of understanding of state requirements or the fear of quality inspections. Many are instructed (or choose) to retain film indefinitely, rather than risk making a mistake that could put themselves or their organization at risk. This can result in a huge amount of wasted storage and resource usage that could be avoided—especially since many older mammographic images have been rendered virtually “undiagnostic” by technology advances over the last 10 years.
When organizations transition to digital imaging, this issue is further compounded by questions regarding the digitization of prior images. It’s important to understand that digitized images of prior film mammograms can be extremely useful and can be used for comparison purposes, but cannot be used to fulfill retention requirements as the FDA mandates that the original film mammogram must remain archived and available.
With all of this in mind, my guidance is to always understand your local and state laws regarding retention of prior mammography images. It’s also essential to have a sound strategy for digitizing analog images that aligns with your workflow, patient needs and country and local mammography quality standards laws. This knowledge, and planning, will serve you and your patients well—and just might help you avoid storing “ancient” films longer than you need.
How does your organization/facility deal with this issue?
– Anne Richards, Clinical Development Manager, Women’s Health