Fox Chase Cancer Center Mammography Facility Fully Accredited Under New FDA Regulations, Effective Today
PHILADELPHIA (April 28, 1999) -- Fox Chase Cancer Center has implemented the final FDA regulations set forth by the Mammography Quality Standards Act of 1992 (MQSA). Effective today, these final regulations are in place to ensure high quality services for early detection of breast cancer, which can then lead to early treatment and higher survival rates. Fox Chase Cancer Center is a fully accredited mammography facility, one of more than 10,000 FDA-certified institutions across the United States.
MQSA was passed to address inadequacies in the quality of mammography services at some facilities. The FDA states that the purpose of this legislation is to help facilities raise their standards of performance, not to close them down. By improving the overall quality and reliability of mammography services, providers will be better able to detect breast cancer in its earliest, most treatable stages.
Under the new regulations, higher standards are in place for the training of facility personnel, condition of equipment, reporting and recordkeeping, and quality assurance. Specific guidelines are in effect regarding the initial qualifications, continuing experience and education, and reestablishing qualifications of physicians who interpret mammograms, radiologic technologists who perform the procedure and medical physicists who survey mammography equipment. All facilities are required to communicate results of examinations to all patients, whether or not they had a referring physician. A classification system is now in place to ensure consistency in the reporting of patient exams nationwide. Image testing is required to take place more frequently and mobile unit performance testing must occur after each relocation.
In addition, MQSA's final rule has introduced new standards for breast implant imaging, has created a system for resolving serious consumer complaints related to mammography services, and has established proper procedures for additional mammography review and patient notification for cases in which the FDA believes quality has been compromised.
Until now, the FDA had posted interim regulations that required all mammography facilities to obtain certification by October 1, 1994 under MQSA. These regulations also established baseline standards to improve the general state of mammography services in this country. The interim regulations were never intended to be final and were in place during the development of the final guidelines.
The FDA developed the final regulations through a cooperative effort with affected medical communities, consumers and the National Mammography Quality Assurance Advisory Committee (NMQAAC). Through publication in the Federal Register, manufacturers, healthcare professionals and consumers had the opportunity to review the proposed regulations and submit comments, which were then addressed by the FDA during the revision process. The Committee, formed as a result of the MQSA, met regularly to guide the development of the final standards and to discuss any relevant issues regarding mammography services.
Facilities must be FDA-certified to lawfully perform mammography and to be reimbursed by Medicare and Medicaid for mammography services. To obtain certification, a facility must successfully complete the accreditation process through one of four federally approved accreditation bodies. The FDA has approved the American College of Radiology (ACR) and the States of Arkansas, California, and Iowa as accreditation bodies. Finally, an annual inspection by federally trained and certified federal or state personnel is required to maintain certification.
All mammography facilities that produce, process, or interpret mammograms as well as accreditation bodies must comply with MQSA requirements. Personnel involved in the production, processing or interpretation of mammograms must also meet these requirements.
The National Cancer Institute's Cancer Information Service at Fox Chase Cancer Center can provide you with a list of FDA-certified mammography facilities in your geographic area. Simply call 1-800-4-CANCER.
Fox Chase Cancer Center is one of 35 National Cancer Institute-designated comprehensive cancer centers in the nation. The Center's activities include basic and clinical research including prevention, detection and treatment of cancer, and community outreach programs.
Fox Chase Cancer Center, part of Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase also was among the first institutions to receive the National Cancer Institute’s prestigious comprehensive cancer center designation in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are routinely recognized in national rankings, and the Center’s nursing program has achieved Magnet status for excellence three consecutive times. Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research and oversees programs in cancer prevention, detection, survivorship, and community outreach. For more information, call 1-888-FOX-CHASE (1-888-369-2427).