Tracking/Surveillance
What is tracking/surveillance in the mammography field?
In the mammography field, tracking is when a facility monitors all events associated with a patient from the initial exam to the final exam and any future testing conducted. Tracking is also called surveillance in some instances, but for this article, the word tracking will be used throughout.
What are the standards a facility is required to meet for patient tracking?
According to the FDA, at minimum, each facility must track all positive (BI-RADS® Suspicious and Highly Suggestive of Malignancy) mammogram findings and relate them to subsequent biopsy results. This must be conducted on an annual basis. Additional information required for facilities to record in patient tracking records includes, but is not limited to:
- Procedures to track mammograms
- Determine if biopsies were conducted for a patient and if the biopsy was benign or malignant
- Any patient who was subsequently found to have cancer that wasn't detected through their mammogram
You can view the complete requirements for facility tracking on the FDA's MQSA Compliance Guideline page.
Why is tracking important?
Patient tracking is important for a multitude of reasons. First, tracking allows a facility to evaluate if any of its patients are overdue for imaging, biopsies, or other procedures relating to screening/diagnostic evaluations. If a facility is kept up-to-date on its patients' needs for evaluation and uses this data to keep patients updated on their screening/diagnostic breast examinations, the chance of detecting early-stage, small-node cancers may increase. Additionally, patient tracking can help the facility determine if they are meeting performance benchmarks, as the patient data recorded in tracking systems can be used to calculate these measures. Even though the FDA MQSA requires a certain level of tracking, facilities can benefit from the many positive effects of patient tracking.
Sources:
U.S. Food and Drug Administration. (n.d.). Preparing for MQSA Inspections Compliance Guidance. FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-guidance-mammography-quality-standards-act-final-regulations-preparing-mqsa-inspections