The Mammography Quality Standards Act ( MQSA ) is enforced by the United States Congress to regulate the quality of care in mammography. The action was officially effective in 1994, and extended in 2004 to continue until 2007. The US Food and Drug Administration (FDA) began inspection of mammography facilities to ensure compliance in 1995. In 1997, a more comprehensive regulation was added to effective in 1999.
The FDA explains MQSA:
The Mammography Quality Standards Act requires mammography facilities nationwide to meet uniform quality standards. Congress passed this law in 1992 to ensure high-quality mammography for early detection of breast cancer, which can lead to early treatment, treatment options that lead to an increased likelihood of survival. By law, all mammography facilities should be: 1) accredited by an FDA-approved accrediting body, 2) certified by the FDA, or the State, as required, 3) undergoing annual MQSA examinations, and 4) clearly display the certificate issued by agency.
Video Mammography Quality Standards Act
Histori
In a nationwide survey of mammography facilities conducted in 1985, called Nationwide Evaluation of X-ray Trends (NEXT), the US Food and Drug Administration found 36 percent to produce mammographic images of unacceptable quality. The FDA also found that 15 percent of the facility uses general purpose X-ray equipment for mammography. The American College of Radiology responded by initiating a voluntary accreditation program for this facility in August 1987 and found that 30 percent of facilities failed on their first application for accreditation.
Evidence from the 1990 General Accounting Office (GAO) study shows that many mammography providers do not have an adequate quality assurance program. From June 20 to 22, 1990, NBC Nightly News correspondent Michelle Gillen presented a three-part series on mammography quality issues. In 1992, a hearing held by the Senate Committee on Labor and Human Resources found many quality problems in the field of mammography.
Congress passed the MQSA on October 7, 1992. The responsibility for implementing the MQSA was delegated to the FDA by the Secretary of the Department of Health and Human Services (DHHS) on 2 June 1993. The action became effective October 1, 1994, and required all mammography facilities to meet quality standards as set by the Food and Drug Administration (FDA). The FDA issued a provisional regulation on December 21, 1993, as a mechanism to accredit and certify facilities on October 1, 1994.
The FDA found 10,142 certified facilities operating, as of December 15, 1994. During the first year of the MQSA, 26 percent of the facilities suffered significant violations, while 10 percent did so in the second round of inspections. On 28 October 1997, the FDA issued a comprehensive set of comprehensive rules, which became effective on 28 April 1999, guiding the accreditation process. They accredited and certified 10,161 mammography facilities as of December 31, 1997.
The 1998 estimate concludes that the inspection cost of each facility is $ 1,549 per year and the average cost of achieving compliance with MQSA is $ 18,000. Costs to meet temporary regulations, including staff training, equipment upgrades, upgrading of quality assurance programs, and increased notification of outcomes to patients, are estimated at $ 24 million per year. The additional cost of facility compliance with the 1997 regulation increased this figure to $ 62 million per year.
The number of certified facilities operating on December 31, 1997, was about 4 percent less than before when the MQSA came into effect on October 1, 1994. Of the 369 closures just prior to October 1, 113 can be directly attributed to the MQSA.
On November 9, 1997, the Senate passed S. 537, the "Reauthorization Standard of Mammography Quality Standard," with unanimous consent, to re-authorize the MQSA for another 5 years.
Maps Mammography Quality Standards Act
Accreditation body
MQSA requires facilities to be "accredited by an FDA approved accreditation body." Currently the only nationally approved body is the American College of Radiology (ACR).
State-level alternatives to the ACR are the Arkansas Health Department, the Iowa Department of Public Health, and the Texas Department of Health Services.
Effects on patient
MQSA is intended to maintain high quality mammography in the United States and its territory. Changes in the final rules that directly affect ordinary patients include:
- The mammography facility is required to provide mammogram results in patients with writing in an easy-to-understand language. Also known as "lay report".
- Consumer complaints mechanisms are required to be established in mammography facilities to provide patients with a process to address their concerns.
- Patients can obtain their original mammogram, not a copy, when needed.
- For cases where facility mammograms are determined to be substandard and at risk for public health, facilities will inform patients and their doctors and suggest appropriate action plans.
References
External links
- MQSA program
- Full text of the modified action
- National Statistics for the MQSA Program
- ACR Home page
Source of the article : Wikipedia
0 Comments