FDA Stops Mammography Services at University Park OBGYN Due to “Serious Risk to Human Health”
The mammography services at a Sarasota, Florida-based facility were suspended by the FDA due to a “serious risk to human health,” according to the agency’s Tuesday announcement.
In August, the American College of Radiology informed University Park OBGYN about the quality concerns regarding their exams. The college’s accreditation division conducted a mammography review from April to July of the previous year and found that six of the thirty cases did not meet the ACR’s image evaluation criteria. Some of the deficiencies were considered “severe.”
As a result of the findings, University Park’s accreditation was revoked in September, without the facility opting to appeal.
The FDA stated on April 25, 2023 that the facility’s practices posed a serious threat to human health, based on information obtained from the ACR about the reason for the revocation of the accreditation.
As per the FDA’s regulations, University Park OBGYN informed both referring providers and patients who had mammograms performed at the facility from April to September about the situation. The business successfully completed the ACR’s corrective action plan, leading to the reinstatement of their accreditation on April 11. The FDA then issued a Mammography Quality Standards Act certificate, allowing University Park OBGYN to legally perform exams.
What is the Mammography Quality Standards Act?
The Mammography Quality Standards Act (MQSA) is a federal law enacted by the United States Congress in 1992 to ensure the quality of mammography services nationwide. The MQSA establishes standards for the accreditation of mammography facilities, the certification of mammography equipment, and the qualifications and training of mammography personnel. The law is administered by the U.S. Food and Drug Administration (FDA) and aims to improve the accuracy and early detection of breast cancer through mammography.
Under the MQSA, all mammography facilities must be accredited by an FDA-approved accreditation body, such as the American College of Radiology (ACR) or the Radiological Society of North America (RSNA). Accreditation is granted after a facility has demonstrated that it meets the minimum standards for equipment, quality control procedures, and personnel qualifications.
The MQSA also requires that mammography facilities undergo regular inspections to maintain their accreditation and that they provide patients with a written report of their mammogram results. In addition, the law requires that mammography equipment be regularly tested and maintained to ensure its accuracy and reliability.
The MQSA has been instrumental in improving the quality of mammography services in the United States and has led to the early detection of many cases of breast cancer. The law has also helped to standardize mammography practices and procedures, ensuring that all women receive consistent, high-quality care, regardless of where they live or receive their care.
CONTACT PARKER WAICHMAN LLP TODAY FOR A FREE CONSULTATION
If you or a loved one suffered harmful medical malpractice, a breast cancer misdiagnosis, or were not diagnosed with breast cancer due to the lack of quality mammography services at University Park OBGYN in Sarasota, Florida, Parker Waichman LLP is here to help you.
As experienced medical malpractice attorneys, we understand the devastating impact that a misdiagnosis or failure to diagnose breast cancer can have on your life, and we are committed to fighting for the rights of those who have been affected.
State law limits the time you have to file your claim. Speak to our attorneys by calling 1-800-YOUR-LAWYER (1-800-968-7529) or contact us online to receive a free, no-obligation consultation. We will provide you with the support and guidance you need to protect your rights and seek the compensation you deserve. Together, we can ensure that your voice is heard and that you receive the justice you deserve.
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