How to Start a Mammography Program: What Every Facility Needs to Know Before Day One

“Setting up a breast center,” says Jennifer Gillman, Women’s Health Director at Brown’s Medical Imaging, “is like creating the biggest computer you will ever create.”

She is not exaggerating.

Mammography files alone can bring down healthcare networks that weren’t built to handle them. You must also navigate the ACR accreditation process, schedule your physicist, configure your PACS system, establish your quality control program, train your staff to MQSA standards, and figure out how to bill for it all.

Most people who decide to start a mammography program are clinical experts. They understand breast imaging at the highest level. What they often don’t know, and what nobody hands them a roadmap for, is the operational, regulatory, and business infrastructure required to actually launch.

Gillman has seen this firsthand, more than once. She described a recent discussion with a breast radiologist in the Fort Lauderdale area. Her contact was accomplished, experienced, and ready to leave a large enterprise to open her own center. But she was so overwhelmed by the complexity of getting started that she didn’t know where to begin. BMI drove a Fujifilm demo RV with a full mammography suite to the radiologist’s home just to start the conversation.

“She didn’t know how to get it started,” Gillman said. “She’s busy. She doesn’t even have time to look at new equipment.”

If that sounds familiar, this guide is for you.

Start Here: Contact the ACR Before You Buy Anything

The single most common mistake facilities make when planning a mammography program is getting excited about equipment before understanding the regulatory framework. Before you purchase a single piece of equipment, your first call should be to the American College of Radiology.

The ACR is the federally approved accrediting body for mammography in the United States. Whether replacing an existing unit, adding capacity, or launching a brand-new program, every facility must have its equipment accredited before examining patients. 

From there, the ACR guides you through a multi-step accreditation process that ends with a provisional certificate from MQSA — the FDA’s Mammography Quality Standards Act program — allowing your facility to operate. You must have that certificate before seeing your first patient.

The timeline between installation and that certificate is tighter than most facilities expect, and the steps need to happen in the right sequence.

The Infrastructure Nobody Warns You About

Here is where most new mammography programs get surprised.

Gillman described it simply: mammography files are “the largest files” in healthcare imaging and “they crash healthcare networks” that weren’t designed to handle them.

A single screening examination (four images, 2D and 3D) generates on average 655 megabytes of data. With jpeg lossless compression, that range extends to 1.5 to 3 gigabytes per study. And unlike other imaging modalities, mammography carries a legal requirement to compare current images against five to seven years of prior studies. The moment you open your program, prior images from other facilities start flowing in.

Your IT infrastructure must be ready for this before your first patient walks through the door, and the requirements are more specific than standard hospital imaging infrastructure. Bandwidth, network configuration, storage capacity, and power requirements all need to be addressed in advance, in coordination with your IT and facilities teams. 

Training Requirements: More Than Most Programs Expect

MQSA sets specific, non-negotiable training requirements for both technologists and radiologists, and the hour requirements are just the beginning.

Before a technologist can independently perform mammography exams on any new modality, MQSA requires 8 hours of initial training on that specific system. Before a radiologist can read Digital Breast Tomosynthesis studies, MQSA requires 8 hours of DBT training, separate from any general mammography training they may already have. These requirements apply regardless of experience level.

After installation, a medical physicist must test the unit before it is used for clinical imaging. Your facility is responsible for scheduling and paying for the physicist, and that report becomes part of your accreditation submission.

What most facilities don’t realize is that the sequence in which all of this happens matters as much as the requirements themselves. Getting the order wrong causes delays that push back your launch date.

Quality Control: Choosing Your Program Wisely

In 2016, the FDA approved an ACR alternative quality control program that gives facilities a choice: follow the 2018 ACR Digital Mammography Quality Control program, or follow the vendor’s QC program.

Facilities that choose the ACR QC program are required to perform quality control on their reading monitors, an additional step that vendor QC programs do not require.

Neither choice is inherently better. But the choice needs to be made intentionally, documented clearly, and followed consistently from day one. The ACR Digital Mammography QC manual is available for download and provides the full requirements for facilities choosing the ACR program.

This is one of those decisions that is easy to get right at the start and difficult to correct later.

The Business Side: Where Most Programs Leave Money on the Table

This is where BMI’s perspective goes beyond what most equipment vendors offer because Gillman approaches every new program not just as an equipment sale, but as a business consultation.

“If you have 2,000 women in your county who are 40 or older, but you only have 800 women getting mammograms,” Gillman said, “you’re not maximizing your mammography program.”

The revenue gap in most new mammography programs is bigger than administrators expect, and it’s not just about screening volume. The business model of a mammography-only program has a structural limitation that most facilities don’t discover until after they’ve launched. 

Marketing Your New Program From Day One

Opening a mammography program is not enough. Patients need to know you exist, and referring physicians need to trust that your program meets the standard of care they expect.

BMI offers a promotional video recorded on-site, including patient testimonials, technologist feedback, and footage of your mammography suite. This is content you can use across your website and social channels from the day you open.

Fujifilm’s marketing team provides customized collateral and press releases for new program launches. And the ACR’s CME Toolkit offers downloadable materials specifically designed for referring physicians and patients.

Your marketing begins before your first patient, and the facilities that plan for it from the start are the ones that build a wait list.

Ready to Get Started?

BMI’s Women’s Health team has decades of experience helping facilities launch and grow mammography programs. They’re ready to help you.

Schedule a Consultation | Call 800-701-XRAY (9729)