When FDA designed the MQSA inspection program, we realized that some inspection observations would have a greater impact on the quality of mammography than others. For this reason, FDA adopted different levels of severity (or significance) for inspection observations.
There are three possible levels of observations resulting from an MQSA inspection. They range from Level 1 (representing the most serious noncompliances with MQSA standards) to Level 3 (representing minor deviations from MQSA standards).
A Level 1 observation indicates that the inspector found one or more deviations from MQSA standards that may seriously compromise the quality of mammography services offered by the facility.
A Level 2 observation indicates that the facility’s performance is generally acceptable. However, the inspector did find one or more deviations from MQSA standards that may compromise the quality of mammography services offered by the facility.
A Level 3 observation indicates that the facility’s performance is generally satisfactory. However, the inspection did show one or more minor deviations from MQSA standards.
If there are no observations, the inspection report will note "All Items in Compliance."
If any observations have not been corrected or have recurred since a facility’s last MQSA inspection, they are identified as "Repeat."