by W. G. Mourad, Ph.D.
Information Management Branch
Division of Mammography Quality and Radiation Programs
This article covers two very important issues in mammography practice. The first one deals with the contents of the mammography report and the second with communicating the results of the examination to patients and health care providers.
Mammography Report Contents
1. Interpreting Physician’s Name and Final Assessment Category
According to the final regulations, the facility must prepare a written report of the results of the mammography examination performed under the facility’s certificate. Furthermore, the report must be dated and must include, among other things, the name of the interpreting physician who interpreted the mammogram and an overall final assessment of findings, classified in one of the following six categories:
- Probably benign
- Highly suggestive of malignancy
- Incomplete: need additional imaging evaluation.
Having this information in the mammography report is a vital part of the facility’s responsibility to its patients. It also plays a major part in evaluating and auditing the results of the medical outcomes at the facility, and failure to include this information is detrimental to the practice of mammography.
Because of the importance of having uniform terminology nationwide, the final regulations specifically defined the six finding categories listed above. However, ACR’s “BIRADS” assessment categories were already in existence prior to the final regulations and were widely used in practice. Therefore, FDA published guidance concerning acceptable variations on the six categories defined above that are based on ACR’s BIRADS categories used in practice.
To emphasize the seriousness of the above requirements, MQSA inspectors will issue a Level 2 violation if they find that even one out of five randomly selected mammography reports does not identify the interpreting physician or contain an overall final assessment category as defined above.
Inspection results over the past three fiscal years indicate that, while the number of facilities cited for the lack of an interpreting physician’s identification on the report has remained relatively small (averaging less than 10 per year), the number of those cited for the lack of a final assessment of findings (termed Facilities with No Assess. Categ.), as defined above, has continued to represent a significant fraction* of all facilities cited with any Level 2 finding as the highest (termed All L2 Facilities). This result is illustrated in Graph 1 below, which shows that, while the total number of facilities cited in either category has continued to drop over this period, there is considerable room for improvement.
* This fraction was 33% in FY00 but has gradually dropped to 20% in FY02. By comparison, the fraction of facilities cited with any processor or phantom QC violations has been about 40% of all L2 facilities, as indicated in our previous article.
Graph 1. Number of Facilities Cited for Mammography Reports with No Final Assessment Category - FY00 to FY02
2. Results Communication System
Communication of the mammography examination results to patients and health care providers (referring physicians) was one of the issues that prompted the US Congress to pass the 1992 Mammography Quality Standards Act (MQSA). When Congress reauthorized MQSA in 1998, it emphasized this issue further by adding a new requirement concerning sending the lay summary to the patient.
According to the amended final regulations, which became effective on April 28, 1999, the facility must send a written report containing an assessment of the results of the mammography examination to the health care provider (and to the patient herself, if self-referred), and must also send a lay summary to the patient, within 30 days after the examination. Furthermore, if the results of the examination indicate an assessment of "suspicious" or "highly suggestive of malignancy," the facility must make reasonable attempts to communicate the results to the patient and health care provider as soon as possible.
Recognizing that failure to inform health care providers and patients of their results represents a major detriment for the quality of mammography practice and has a serious impact on women’s health, FDA designated the failure to communicate examination results within 30 days as a Level 1 noncompliance. Thus, a facility would be cited at Level 1 if it fails to have an adequate communication system, e.g., if it does not have any one of the following:
- A system to provide medical reports (to referring health care providers or self-referred patients) within 30 days
- A system to provide lay summaries (to all patients) within 30 days
- A system to communicate serious (suspicious or highly suggestive of malignancy) cases to health care providers and patients as soon as possible.
Inspection results over the past three fiscal years indicate that the number of facilities cited for not having an adequate "results communication system" to patients and health care providers (termed Facilities with No Communication Sys.) has continued to represent a significant fraction of all facilities cited with any Level 1 finding (termed All L1 Facilities). This result is illustrated in Graph 2 below, which shows that, while the total number of facilities cited in either category has continued to drop over this period, there is considerable room for improvement.
Graph 2. Number of Facilities Cited for Not Having an Adequate Results Communication System - FY00 to FY02
To help facilities comply with the requirements for mammography reports and other regulatory mammography issues, FDA has developed ample guidance. You can access this guidance through FDA’s Policy Guidance Help System (PGHS), which is located under the heading "Guidance" on this web page.