1. (1) The facility shall maintain:

   1. (a) documentation that each employee has been trained on safety standards for radiation;
   2. (b) documentation that the mammogram unit is safe and that proper radiation safety practices are being followed; and
   3. (c) policy and procedure manuals and logs for equipment and quality control.

2. (2)(a) Each facility shall implement a quality control program for:

   1. (i) equipment;

      1. (ii) film processors approved by the Department of Environmental Quality; and
      2. (iii) mammogram unit performance.
   2. (b) Each facility shall maintain stated objectives achieved by procedures comparable to objectives and procedures in the ACR 2018 Digital Mammography Quality Control Manual, Revised 2nd Edition, May 2020, incorporated by reference in this rule.
   3. (c) The facility shall maintain documentation that the quality control program complies with ACR quality controls for mammography or the equivalent.
   4. (d) Each ACR-accredited mammography program facility shall document compliance with the mammogram unit quality control requirements in this section.

KEY: health care facilities, mammography

Date of Last Change: June 5, 2026

Notice of Continuation: August 13, 2021

Authorizing, and Implemented or Interpreted Law: 26B-2-202; 26B-2-602; 42 U.S.C. 263b; 21 CFR 900.12(c)(2)