June 6, 2016 — A new report from the U.S. Food and Drug Administration (FDA) details the training process for its 200-plus inspectors that perform the annual inspections of over 8,700 mammography facilities. The inspectors cover facilities in the United States, its territories and its military bases abroad.
Every year approximately 15-20 students arrive at FDA’s headquarters in White Oak, Md., according to the agency. The Division of Mammography Quality Standards (DMQS) in the Center for Devices and Radiological Health, in collaboration with the Office of Regulatory Affairs, conducts annual MQSA Inspector Training for students from states and FDA districts across the country. The FDA said prospective inspectors have diverse backgrounds ranging from students who are radiologic technologists to those who are physicists or equipment service engineers.
The rigorous training to become a Mammography Quality Standards Act (MQSA)-qualified inspector consists of three parts: Courses I and II are online, with a focus on radiation physics and X-ray imaging and image processing; and Course III is an on-site, two-week-long course which focuses on reinforcing the theory and providing practical sessions simulating what might be encountered during a facility inspection, and knowledge testing.
According to the FDA, the call for nominations for MQSA training occurs in September of each year. Course I starts in January, Course II in February and March, and Course III is given in April at FDA headquarters. The training is for students from states with whom FDA contracts to conduct MQSA inspections (44 states have MQSA contracts), as well as from states who are certifiers and students who are FDA employees.
The minimum qualifications for students to qualify for MQSA Inspector training include:
- A bachelor’s degree (B.A. or B.S.) from an accredited college or university with a major in physics or with a major in another field but with at least 30 semester hours in physical, health or life sciences at the college level; or
- A bachelor’s degree in radiologic technology; or
- Certification by the American Registry of Radiologic Technologists, with at least two years of experience in diagnostic radiologic technology or radiological health work; or
- General or unrestricted state licensure to practice diagnostic radiologic technology plus at least two years of experience in diagnostic radiologic technology or radiological health work; or
- An associate’s degree in science, or at least two years of college level courses, with at least 16 semester hours in science, plus at least two years of experience in diagnostic radiology or radiological health work.
Course I, Introduction to Radiologic Health Physics, an online course, provides students with the fundamental concepts of radiation physics in an effort to provide the basis for inspections of diagnostic medical radiographic/fluoroscopic medical X-ray facilities.
Course II covers the basic patient mammography examination, mammography X-ray systems, film and digital imaging processing, and quality assurance procedures specific to mammography. After completing this course, the inspector will be able to define and apply MQSA concepts to mammography quality and the MQSA inspection procedures. A comprehensive final exam must be passed at the end of the course. When the student has successfully completed the course, DMQS awards them a Certificate of Completion. Students are then required to accompany and observe an already MQSA-qualified inspector on at least two inspections to gain practical field experience prior to attending Course III, according to the FDA.
Course III focuses on simulated facility inspections and evaluations of mammography X-ray systems. After successfully completing Course III, the FDA said students are required to perform at least three mentored inspections under the direct supervision of an MQSA-qualified inspector.
The agency said MQSA inspectors are required to maintain continuing education requirements. They must have taught or earned a total of 15 Mammography Continuing Education Units every 36 months. FDA provides funding to assist with maintaining this requirement. The requirement is a minimum, and FDA encourages inspectors to obtain more than the minimum requirement. MQSA-qualified inspectors must also meet continuing experience requirements. Each inspector must complete at least 24 MQSA inspections every 24 months.
DMQS continuously strives to improve the training content and process by soliciting feedback from the inspectors and monitoring compliance and technological trends in mammography. Some examples include making the course material more focused on digital technology. Additionally, making more information online increases opportunities for initial and continuing education. The program, with the help of FDA field personnel, also created a mechanism to provide training in between training program cycles when there is an urgent need, and made the evaluation and testing process more transparent so that both students and the entities that submit their names for training are more aware of what it takes to become an MQSA inspector.
Since the inspector training program began in 1994, over 90 FDA and 500 state inspectors have qualified through this MQSA program, the agency said. These dedicated inspectors, along with mammography facilities themselves, and MQSA partners such as accreditation bodies, state regulatory agencies, certifying states, and FDA district offices, help ensure women have access to quality mammography in order to detect breast cancer in its earliest, most treatable stages.
For more information: www.fda.gov