Section R. 333.5687 - Radiologic technologist quality control testsRule 687. A stereotactic breast biopsy facility shall have a radiologic technologist perform the following quality control tests at the intervals specified in this rule:
(a) A localization accuracy test shall be performed daily before the equipment is used on patients. Each of the indicated needle tip coordinates shall be within 1 millimeter of the actual preset needle tip location.(b) A phantom image evaluation shall be performed at least weekly. The phantom image shall achieve at least the minimum score established in R 333.5689.(c) A hard copy output quality test shall be performed at least monthly, if hard copies are produced from digital data.(d) A compression test shall be performed at least semiannually. The maximum compression force for the power drive mode shall be between 25 pounds and 45 pounds.(e) A repeat analysis shall be performed at least semiannually. If the overall repeat or reject rate exceeds 20% based on an image volume of not less than 150 patients, the reason for the change shall be determined. A repeat analysis shall be assessed semiannually even if fewer than 150 patients are examined during that period.(f) If stereotactic breast biopsy is performed using a screen-film system, the following tests shall be required: (i) A processor quality control test shall be performed at least daily. Film processors used to develop stereotactic breast biopsy films shall be adjusted and maintained to meet the technical development specifications for the mammography film in use. A processor performance test shall be performed at the beginning of each operational day before processing any clinical images. The test shall use the mammography film used clinically at the facility and shall include an assessment of base plus fog density, mid-density, and density difference as follows: (A) The base plus fog density shall be within 0.03 of the established operating level.(B) The mid-density shall be within plus or minus 0.15 of the established operating level.(C) The density difference shall be within plus or minus 0.15 of the established operating level.(ii) An analysis of fixer retention in film assessed at least quarterly. The residual fixer shall be not more than 5 micrograms per square centimeter.(iii) A screen-film contact test shall be performed at least semiannually. Testing for screen-film contact shall be conducted using 40 mesh copper screen. All cassettes used in the facility for stereotactic breast biopsy shall be tested.(iv) A test of darkroom fog shall be performed at least semiannually. The optical density attributable to darkroom fog shall not exceed 0.05 when a mammography film of the type used in the facility, which has a mid-density of not less than 1.2 optical density, is exposed to typical darkroom conditions for 2 minutes while the film is placed on the counter top emulsion side up.Mich. Admin. Code R. 333.5687
2016 MR 10, Eff. 5/25/2016