Section 325.5686. Quality assurance records.

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(1) The lead stereotactic breast biopsy physician, quality control technologist, and medical physicist shall ensure that records concerning the following items are properly maintained and updated:

(a)   ) Stereotactic breast biopsy techniques and procedures.

(b)   Quality control, including monitoring data and corrective actions taken.

(c)   ) Safety.

(d) Employee qualifications to meet assigned quality assurance tasks.

(2)   The quality assurance records specified in subrule (1) of this rule shall be kept for each test specified in R 325.5684 to R 325.5698 until the next annual inspection has been completed and the department has determined that the facility is in compliance with the quality assurance requirements, or until the test has been performed 2 additional times at the required frequency, whichever is longer.

                    
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