MQSA Hot Topics (Continued)
Last Updated September 19, 2005 5

The ACR manual states that taking a 5-day density average of sensitometric strips is the proper procedure for establishing or re-establishing processor QC operating levels. The FDA has gone further to state that, “ the number of days needed to establish the operating levels depends on the time it takes for the processor to reach chemical equilibrium or a "seasoned" status. In practice, this is usually achieved when the chemicals in the developer tank have been replaced or "turned over" 2-3 times. For a given film, this time is a function of the developer tank size, the replenishment rate, and the number of films processed (patient volume). Also, different film emulsion types have different replenishment rates per sheet of film, thus requiring different periods for the same processor to reach a seasoned status.

Based on experience to date, we expect the majority of facilities to use up to a 5-day averaging period. However, if a facility uses a longer period, it should provide empirical data or recommendations from the film manufacturer explaining the reasons for the longer time period. Regardless of the length of time needed for establishing or re-establishing operating levels, the facility must document the MD, DD, and B+F values daily. Even though there are no regulatory action limits during this period, monitoring of processing conditions is still important as these values may identify problems with developer temperature, replenishment rates, and other variables.”

The inspectors will be checking to make sure you are following your QC test procedures carefully. The inspectors will be checking the documentation from the film manufacturer’s recommendation, if for any reason the facility is using greater than 5 days to establish or re-establish sensitometric operating levels.

The Infection Control Policy is addressed in MQSA as the following:

21 CFR 900.12(e)(13) Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials. This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall:

• Comply with all applicable Federal, State, and local regulations pertaining to infection control; and

• Comply with the manufacturer's recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or

• If adequate manufacturer's recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available.

The Infection control policy should include the following information:

• Name of the disinfectant used

• Manufacturer recommendations for disinfectant

• Copy of disinfectant reference material, for example: instructions for use

• Step-by-step instructions on how to disinfect the mammography unit when contaminated with blood or other potentially infectious materials, for example: where to spray the disinfectant (on the cloth), and how long to leave the disinfectant on the unit, etc.

• How to disinfect gross contamination (usually indicated on the disinfectant)

• How disinfection will be documented and where (verification of disinfection is an MQSA requirement)

Documentation of in-between patient cleaning is not a requirement of MQSA, but the written procedure for performing this task is required.

It is advisable for ease during the inspection and for the facility employees, that these items be clearly stated and that a copy of the manufacturer’s recommendations be kept with the disinfection policy.

Conducting the daily processor QC when the sensitometer is not available. On 10-18-1999, FDA approved a request for an alternative to sensitometric-densitometric testing of processor performance that can be used for a period of up to 2 weeks when the facility’s sensitometer is unavailable.

When using the alternative test, processor performance is considered satisfactory if:

1. The optical density of the film at the center of an image of a standard FDA-accepted phantom is at least 1.20 when exposed under typical clinical conditions.

2. The optical density of the film at the center of the phantom image changes no more than +/- 0.20 from the established operating level.

3. The density difference between the background of the phantom and an added test object, used to assess image contrast, is measured and does not vary by more than +/- 0.05 from the established operating level.

In addition

4. To evaluate base+fog an additional measurement of density must be made either of a shielded portion of the phantom image film or of an unexposed film. In accordance with 21 CFR 900.12 (e)(1)(i), the base+fog density must be within +0.03 of the established operating level.