MQSA Regulations: Are You Ready?

Effective September 10, 2024, the FDA has mandated updates to the Mammography Quality Standards Act (MQSA) regulations. Facilities must comply with new requirements, including breast density notifications in mammography reports and patient summaries.

What are the Key Updates?

Mammography Reports: Must include the facility’s name and location, a final assessment of findings in specific categories, and an overall assessment of breast density.

Patient Lay Summaries: Must include the patient’s name, facility information, and a breast density notification statement.

Communication of Results: For findings categorized as “Suspicious” or “Highly Suggestive of Malignancy,” reports must be provided to healthcare providers and patients within seven days. For incomplete assessments, follow-up reports must be issued within 30 days.

Medical Outcomes Audit: Annual audits must include metrics such as positive predictive value, cancer detection rate, and recall rate for each interpreting physician and the facility.

Additional requirements include maintaining personnel records for a specified duration, stringent recordkeeping of original mammograms and reports, and protocols for transferring or releasing mammography records within 15 days upon request.

Facilities failing accreditation three times cannot reapply for one year, and all mammography devices must meet FDA premarket authorization requirements.

These updates aim to improve the quality and accuracy of mammography services and ensure better patient communication and record management​.

 

Facilities that must comply with the Mammography Quality Standards Act (MQSA) include:

  1. Mammography Facilities: Any facility that provides mammography services, which includes hospitals, outpatient imaging centers, and private radiology practices.
  2. Mobile Mammography Units: These are mobile facilities that travel to various locations to provide mammography services and must meet the same MQSA standards as stationary facilities.
  3. Diagnostic Clinics: Clinics that perform diagnostic mammography to further investigate abnormalities found during screening mammograms.
  4. Screening Centers: Facilities that focus on providing routine mammograms to screen for breast cancer in asymptomatic women.

 

These facilities are required to comply with MQSA regulations to ensure high standards of care, including the quality of mammography equipment, the qualifications of personnel, and the quality of mammogram images​. If you partner with a teleradiology company like Vesta, we ensure reports adhere to these updates. Vesta is always ahead of the curve when it comes to regulations and working with their clients not only to educate them on what is coming but also work closely with them to put in place and roll out any new requirements. 

 

Sources:

fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program/important-information-final-rule-amend-mammography-quality-standards-act-mqsa
openai.com

 

 

Medical Ultrasound Awareness Month: Advancements Through the Ages

Ultrasounds—to many not in the medical field, the image of a woman getting her pregnant belly examined is often something that comes to mind first. However, as medical industry professionals, we understand that ultrasounds go way beyond that.

ultrasounds

It’s really amazing to actually look at the history and advancement of such an important diagnostic tool especially during October–Medical Ultrasound Awareness Month.

In simple terms, the ultrasound scan isn’t just a medical device that can help track the development of a baby during pregnancy. The ultrasound scan can also help with the following:

  •       Observing the ovaries and uterus
  •       Evaluating blood flow
  •       Diagnosing gallbladder disease
  •       Examining a lump in the breast
  •       Checking thyroid glands
  •       Guiding a needle
  •       Diagnosing prostate issues

This machine is non-invasive, safe, and does not use ionizing radiation.

History of Ultrasound

The first recorded use of the ultrasound was in 1794 when Italian physiologist Lazzaro Spallanzani used ultrasound to study how bats navigated at night. This became the foundation for modern ultrasound physics. 

Bats produce ultrasounds in order to catch prey.

Ultrasound was initially used to detect flaws in metal casings. It was not used clinically until 1956 by Dr. Ian Donald and Tom Brown. There are no known side effects for ultrasound, making it an incredibly safe and efficient imaging device.

Advancements in Ultrasound

Ultrasound machines have become progressively mobile, easy to carry, and smaller while providing high-quality imaging. Since they are non-invasive and cost-effective, doctors can use them to track patient development without the risk of radiation.

Ultrasound technology can allow us to have an excellent view of the body’s vascular system by tracking microbubbles. 3-D imaging is also possible for more precise diagnostics.

As technology continues to expand, our medical devices tend to shrink inversely. Now, medical professionals can increase their diagnostic capabilities from anywhere in the world. For example, some handheld ultrasound devices weigh under a pound and can hook up to your smartphone, help healthcare providers quickly scan their patients—and possibly save lives.

These economical, easy-to-handle devices can change lives globally, predominantly in rural areas. It’s exciting to think that we may only be seeing the beginning of the modern ultrasound age.

How Teleradiology Can Help

Teleradiology, also referred to as remote radiology, provides medical professionals instant imaging result views remotely.  This means that patients have access to better, more immediate health care.

teleradiology servicesStudies suggest that teleradiology offers benefits, including the availability of second opinions and the possibility for remote viewing services. We at Vesta can certainly attest to this! Our clients – hospitals, urgent car centers, physician offices, mobile imaging companies, diagnostic imaging centers, and government institutions—enjoy cost-effective and unrivaled Teleradiology and Telemedicine services any time of day or night.

Benefits of Teleradiology

Teleradiology Benefits

Teleradiology–what an innovative solution for healthcare providers and patients alike! You can simply think of teleradiology like having a radiologist on-call 24/7 for reading and interpreting all types of scans: MRIs, X-rays, CTs, DEXA, PET, DR, mammograms and other images.

What’s more, is that teleradiology enhances the level of patient care and support, because it allows radiologists to extend their expertise to patients and physicians without having to be physically there with them.

Teleradiology is efficient and cost-effective! Save on administrative costs associated with in-house radiology like travel and printing.

 A Partnership in Healthcare

Teleradiology offers chances for medical professionals to partner with one another when barriers of physical distance are present, allowing for substantial professional input regarding various diagnoses and symptoms.

A teleradiology company like Vesta can work specifically with each healthcare facility–be it a hospital, outpatient imaging center, assisted living facility or mobile imaging provider–to offer cost-effective and customizable solutions.

benefits of teleradiologists

Burnout, Retirement and Staff Shortage

We’re noticing specifically that the pandemic pushed many radiologists to retirement. Many hospital and outpatient systems have consolidated their radiology departments which prevents radiologists from providing services outside the system.

What’s more is that the stress healthcare workers feel can mount and burnout results. This can lead to mental health issues and even failure to properly read scans.

burnout radiologist
Mental health and physicians

Where can Vesta Teleradiology help? We offer consultation for all imaging modalities and we can deliver reports with fast turnaround for both STAT and Routine studies.

Your staff is important–they don’t always work around the clock and shouldn’t have to. With our teleradiology services, we fill in those gaps whether it’s during night hours, weekends, holidays–we provide 24x7x365 services. Nighthawk teleradiology coverage allows us to deliver the information your patients need and deserve.