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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Repeat Observations - The Wrong Way to Go

by W. G. Mourad, Ph.D.
Information Management Branch
Division of Mammography Quality and Radiation Programs
5/25/2004

The primary objective of the 1992 Mammography Quality Standards Act (MQSA) has always been to improve the quality of mammography standards nationwide. To achieve this objective, MQSA mandated that only those mammography facilities that have met baseline quality standards can be certified and may lawfully provide mammography services to the public. Under MQSA, all certified facilities must undergo routine fee-based annual inspections. To this end, the FDA developed an inspection program with three observation (violation) levels: Level 1 (L1) for serious observations, Level 2 (L2) for moderate observations and Level 3 (L3) for minor observations.

Regardless of the observation level found during inspections, MQSA requires facilities to correct all problems found during their own quality control (QC) testing and/or MQSA inspections. The ultimate goal of the inspection program is to eliminate all violations of the standards. While this goal is the ideal, the reality of the situation is that, we have always found through inspections, that a number of facilities are cited with one or more observations. Although the number of violative facilities at each level has been steadily decreasing since the final regulations went into effect on April 28, 1999, we continue to find facilities that violate one or more of the same standards repeatedly, e.g., commit violations they were cited for during a previous inspection.

To discourage mammography facilities from repeatedly violating the same quality standard, we developed a procedure to identify and follow-up on these “Repeat” observations. This procedure, which is briefly described below, was designed to escalate FDA’s response to facilities that “don’t seem to learn from their mistakes.”

The inspection software identifies and lists repeat observations at all three levels. An observation in the current inspection is termed a Repeat observation if the facility was cited for it during the previous inspection. Furthermore, the observation is considered a Repeat observation if it is the same type of observation, whether or not it is part of the same entity (e.g., x-ray unit, processor, darkroom, or the same personnel category).

Why should a facility be concerned about repeat observations? If a facility is to improve the way it delivers mammography services, it should, as a first step, correct any deficiencies found during its MQSA inspections. Having a repeat observation is a step in the wrong direction towards improving mammography. Thus, FDA responds to repeat observations as if they were first time observations at the next higher level.

As an example, a first-time L3 observation does not typically require a quick response from the facility regarding how it intends to correct it. Instead, FDA routinely checks on it during the next inspection. If, however, the facility did not correct it, the facility would be cited for this L3 observation during the next inspection as a Repeat L3 observation, requiring the facility to respond to the FDA with a plan to correct the problem within 30 days. In other words, FDA would treat it as if it were an L2 observation. Similarly, a Repeat L2 observation would trigger an FDA response as if it were an L1 observation.

We have recently reviewed inspection data from 10/1/00 to 9/30/03, e.g., over the past three fiscal years 2001 (FY01), 2002 (FY02), and 2003 (FY03).

This data indicate that the number of facilities cited with repeat observations where L1 Repeat was the highest has been between 3.6 and 8.8% of facilities that were cited with L1 as the highest. Likewise, it shows that the number of facilities cited with repeat observations where L2 Repeat and L3 Repeat was the highest, has been less than 10% of facilities that were cited with L2 and L3 as the highest, respectively.

All the data indicate that the total numbers of facilities cited for repeat observations at all levels have remained as a small percentage of all certified facilities over the past three fiscal years. However, they have not decreased at the same rates as facilities cited at the highest level in each group. This trend can be reversed (and should be) if these facilities are more diligent in correcting deficiencies uncovered in a timely manner, thereby improving the quality of mammography they provide.

Inspections with Repeated L1 or Repeated L2 Observations, Grouped by Category

Figure 1 shows the number of facilities cited over the past three fiscal years for repeat observations at either Level 1 or Level 2 in a given inspection category. Note that in this figure, if a facility had repeat observations in more than one category it would be counted once for each category, according to the software query that was written to capture these repeats. Four inspection categories are shown in the figure. The three most prominent ones are: Phantom and processor QC records, medical records and medical audits, and personnel qualification records. The rest are lumped into one category as "Other."

Figure 1 shows the number of facilities cited over the past three fiscal years for repeat observations at either Level 1 or Level 2 in a given inspection category.

While the number of facilities cited for repeat violations in each category is relatively small according to Figure 1, and the total cited in all categories amounts to about 3% of all facility inspections, it is still not viewed by FDA as a mission accomplished since our goal is to see all facilities free from any citations whatsoever, let alone repeat ones.

The number of times a repeat observation in a given category occurred or was cited over each of the three past fiscal years shows a trend similar to that displayed in Figure 1. However, the number of occurrences in a given category is about 30% higher (on average) than the number of facilities cited for a repeat observation in given category, which is not surprising, since the number of personnel and equipment in a given category is considerably higher than the number of certified facilities. (End)

Acknowledgement. Major contributions to this article were made by Timothy J. Haran who wrote the software program, without which, this analysis could not have been done.


Figure Captions
(508 compliance)


Figure 1
. Figure 1 shows the number of facilities cited over the past three fiscal years for repeat observations at either Level 1 or Level 2 in a given inspection category. Graphs representing four inspection categories are shown in the figure. The top three correspond to: 1) phantom & processor QC records; 2) medical records and medical audits; 3) personnel qualification records; The fourth or “Other” category, is the least prominent, includes the rest of repeat L1 and L2 observations not covered in the other three groups.