New Law Alert
No. 3 
May 1999

Mammography Quality Standards Act Final Regulations 
Go Into Effect

• To reach MIEC
• X-Ray release form

On October 28, 1997, the Food and Drug Administration (FDA) published final regulations to implement the Mammography Quality Standards Act (MQSA) of 1992. The Act was written to ensure high-quality mammography for early breast cancer detection and treatment with an increased chance of survival. The final regulations went into effect on April 28, 1999.

The revised regulations for mammography facilities reiterate and expand: personnel require-ments for interpreting physicians, radiology technicians, and medical physicists; equipment standards; reporting and record keeping standards; quality assurance standards; general administrative requirements; breast implant imaging; consumer complaints; facility inspections; and FDA inspections.

On October 9, 1998, President Clinton signed into law the Mammography Quality Standards Re-authorization Act of 1998 which revised and extended the MQSA. These regulations also went into effect on April 28, 1999.

MIEC recommends that doctors review the MQSA and the Reauthorization Act, paying specific attention to the reporting and documentation requirements. These include, but are not limited to:

(1) The overall final assessment of findings on the mammographic report must be classified in one of six categories defined in the regulations;

(2) The report must contain recommendations for additional action(s), when appropriate;

(3) Women who do not have a primary care physician (PCP) must receive both the mammographic report and a summary of the results written in lay terms within 30 days of the examination (or sooner);

(4) Women who have a PCP must be given or sent a summary written in lay terms within 30 days of the examination. The PCP must receive a copy of the mammographic report within 30 days (or sooner); and

(5) The mammography facility must transfer the original mammogram and copies of the patient's reports to a medical institution, a health care provider, or to the patient upon written request from the patient.

To ensure that original mammograms are properly transferred, MIEC recommends that policy-holders develop a tracking system. Facilities should document the date the film was requested, the release date, proper authorization, and to whom the films were re-leased. A follow-up system to recover the films also should be established. Physicians can use the X-ray Release Form.

For news updates and sample patient letters, MIEC encourages radiologists and mammography facilities to contact the American College of Radiologists (ACR) www.acr.org, or by calling 800/227-5463. The Agency of Health Care Policy and Research (AHCPR) also has sample letters for communicating results to women. Call 800/358-9295 and ask for Publication No. 95-0632.