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The Food and Drug Administration (FDA) has set into motion the process of implementing sweeping changes to modernize and improve the current Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The Proposed Rule was published in the Federal Register (Volume 84, Number 60) on March 28, 2019. Publishing of the changes in the Federal Register officially initiates a comment period that ends on June 26, 2019. The FDA proposes adoption of any rule changes based on this proposal become effective 18 months after the date of publication of the final rule in the Federal Register.
A summary of the major provisions of the Proposed Rule outlines three categories of improvements to mammography regulations. These address changes in mammography technology; improvements that enhance enforcement of quality standards; and improvements in the way mammography results are categorized, reported, retained, and transferred to patients and healthcare providers. The improvements to these categories entail the proposal of a dozen specific additions or changes to current MQSA rules.
According to the FDA; "These updates would improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities." 
It should be noted adoption of these proposed rules does come at some cost to the facilities regulated by them. The FDA estimates that annually 1 percent of the total facilities regulated would close or cease to provide mammography services while adding additional burden in transferring of records to all others. That annual burden is estimated to total nearly 1.35 million hours of labor across the 8,691 MQSA certified facilities. The estimate of annualized costs over 10 years ranges from $34.96 million to $60.50 million.
Mammologix encourages its clients and all other interested parties to carefully review these proposed rules. Comments may be submitted either electronically or written under the Paperwork Reduction Act of 1995. Written/paper submissions must be submitted by April 29, 2019. Electronic comments must be submitted on or before 11:59 p.m., June 26, 2019.
 Mammography Quality Standards Act https://www.federalregister.gov/documents/2019/03/28/2019-05803/mammography-quality-standards-act
This Mammologix Mini-Minute is about the abnormal interpretation rate in mammography, otherwise referred to as the recall rate.
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When an examinee has a screening mammogram there are 3 interpretation reported outcomes possible.
The first includes an interpretation by the film reader that the mammogram shows no findings of breast cancer. Examinees with these findings are assessed as either a Bi-Rads Category 1 or 2.
The second is an interpretation of some finding significant enough to require follow-up that could include additional imaging - as indicated by an assessment of a Bi-Rads Category 0 or possibly Category 3. Additionally, on occasion a screening patient may have a finding significant to be assessed as a Bi-Rads Category 4 or 5, requiring tissue sampling.
Any of these 4 assessments are considered to be positive findings and are included in the determination of the abnormal interpretation rate in a screening breast imaging practice.
The third interpretation outcome is reserved for those isolate cases where an examinee undergoes screening mammography after having a prior breast cancer that was proven with tissue diagnosis. In this case, the Bi-Rads Category 6 and is not classified as either a negative or positive finding with regards to calculating recall rate.
According to the Breast Cancer Surveillance Consortium and the American College of Radiology's National Mammography Database, the benchmark for the abnormal interpretation rate is just over 10%.
This means out of 100 screening mammograms performed, 90 examinees will be assessed as negative, while the remaining 10 will have an abnormal finding that requires additional follow-up.
According to the American Cancer Society, of the 10% of examinees who have a screening mammogram and are called back for more tests, 8% - 10% will need a biopsy, with 80% of those biopsies resulting in benign findings. So, for every 1000 screening mammogram examinees, this averages out to be a detection rate of 2 to 4 cancers.
More specifically, the BCSC has identified 10.8% as the 50th percentile abnormal interpretation rate with 8.4% and 14.7% being the 25th and 75th percentile parameters for film readers interpreting at least 1000 screening mammograms or more during the period the data was collected.
To see how your film readers stack up against this benchmark use the mammography medical outcome audit produced by Mammologix. There you will find both the group practice abnormal interpretation rate, along with each individual film reader's individual recall rate.
The information used to compile this segment was collected from sources including an article published December 5, 2016, online at Pubs.RSNA.org entitled; National Performance Benchmarks for Modern Screening Digital Mammography: Update from the Breast Cancer Surveillance Consortium, and references from a Breast Cancer Surveillance Consortiums report titled; Smoothed Plots of Frequency Distributions of Recall Rate for 1,642,690 Screening Mammography Examinations (Among Radiologists with 1000 or More Examinations), 2007 - 2013 Based on BCSC data through 2013.
The Mammologix Support Team manages a library with more than 1000 different templates of lay letters used to communicate test results to mammography examinees. It isn't too much of a surprise that from time to time we encounter questions about certain wording or phrases.
The English language can offer up some rather strange variations in how the words we use to express ourselves are structured in its written form. One of them is about the proper use of healthcare vs. health care.
Turns out “Health care” is in the top 20% most searched words on Merriam-Webster’s online dictionary. But when is appropriate to use the single word compared to its two-word version? And, is it ever necessary to use a hyphen with this wording?
So, is there an easy way to clear up the confusion?
We believe so. Mammologix follows the guidance that allows for both healthcare and health care based on how it is being used in a sentence structure.
When using this wording as a noun and describing a set of actions by a person or persons to maintain or improve the health of an individual then, the two-word version is most appropriate. Here are a few examples;
Healthcare in its one-word version is suitable when used as a noun or adjective describing the delivery of health care as a system, industry, or field that facilitates its delivery to individuals. Examples include;
To learn more about this topic, we suggest this blog post by Arcadia's Implementation Manager, Victor Galli. His passionate and thorough research into this topic offers additional insight into guidance the Mammologix Support Team has adopted about this subject in trying better serve our clients.