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for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
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by W. G. Mourad, Ph.D. |
The quality of products and services provided by a mammography facility is only as good as the qualifications of the professionals who provide them. Mammography quality may be compromised unless all facility personnel have been thoroughly trained to provide the variety of mammography-related services required by their respective roles.
For this reason, MQSA regulations require that mammography professionals meet certain baseline initial qualifications before they can lawfully provide independent services in their respective specialty areas. Furthermore, these regulations also specify that once an individual meets the initial requirements, he or she must meet certain baseline continuing experience and continuing education requirements to remain qualified in his or her specialty area.
For each personnel category, the initial qualification requirements include a combination of academic preparation, certification by certain FDA-approved boards and/or licensing by a State, and initial mammography-specific training and experience. Furthermore, personnel must obtain 8 hours of training in any new mammographic modality before they can independently provide services in that new modality. To verify that a given personnel requirement has been met, MQSA inspectors routinely evaluate personnel records against the regulations and cite the facility if it fails to provide documentation showing that the requirement has been met.
FDA recognizes that all personnel requirements do not affect mammography quality
to the same degree. The failure to meet certain personnel requirements may
have a greater detrimental impact on the quality of mammography than others.
Therefore, FDA has assigned a Level 1 (L1) or a Level 2 (L2) noncompliance
[serious and moderate, respectively] to each of these requirements, depending
on its potential impact on mammography quality.
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Level 1 Personnel Observations |
The FDA issues an L1 citation to the facility if the inspector answers “No” to an inspection question corresponding to any of the following items:
For interpreting physicians:
For radiologic technologists:
For medical physicists:
The number of facilities cited for any L1 personnel observation has always been relatively small and has been steadily decreasing over the past three years. In FY2002, this number was fewer than 50 facilities, which constitutes approximately 0.5 % of all inspections nationwide and approximately 20 % of the total number of facilities cited for any Level 1 observation.
NOTE: Facilities could eliminate the vast majority of these citations by carefully checking personnel qualifications before they hire them, not only to assure that they have met the minimum requirements, but also to assure that the facility has documentation that unambiguously establishes their qualifications at the time of the inspection.
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Level 2 Personnel Observations |
The FDA issues an L2 citation to the facility if the inspector answers “No” to an inspection question corresponding to any of the following items:
For interpreting physicians:
For radiologic technologists:
For medical physicists:
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Level 2 Personnel Observations - Inspection Results |
The number of facilities cited for any personnel L2 observation has been slowly
dropping over the past three fiscal years (FY2000 to FY2002). In FY2002 (FY02),
approximately 10 % of all facilities were cited for having Level 2 personnel
observations. These citations accounted for approximately one-third of the
total number of Level 2 citations.
The facilities cited for any personnel L2 observation (all personnel categories)
may be divided into two groups:
The graph above shows the number of facilities cited for any personnel L2 observation over the fiscal years 2000-2002 (the top line). It also shows the number of facilities cited for any initial qualification L2 observation (Group 1) and the number of facilities cited for any continuing qualification (L2) observation (Group 2), over the same period.
While the number of facilities in Group 1 above (initial qualification observation) has remained relatively small (about 15% of the total), it has been our experience that most of the citations in this group were due to failure to provide, in a timely manner, the documentation needed to verify that the corresponding requirement has been met. How could facilities eliminate the vast majority of these citations? The answer is the same as stated under “NOTE,” at the end of the “Level 1 Personnel Observations” heading.
On the other hand, the number of facilities in Group 2 above continues to constitute the bulk of L2 personnel–related citations. More importantly, the majority of citations in this group were not due to failure to provide timely documentation. Rather, the majority of these facilities were cited because the individual actually did not meet the continuing experience or the continuing education requirement.
Facilities could eliminate these citations by:
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