ARM 37.106.3315. QUALITY ASSURANCE AND PERFORMANCE IMPROVEMENT PROGRAM

(1) An experimental treatment center must have a quality assurance and performance improvement (QAPI) program that: (a) is ongoing; (b) is data-driven; and (c) is broad in scope. (2) The QAPI program must be led by a medical director who meets the definition of ARM 37.106.3304(9). (3) In addition to the medical director, the QAPI program must also include at least one member from each department within the experimental treatment center. (4) The QAPI program will meet at least quarterly and maintain a written record of key information discussed, decisions made, and action items assigned during each meeting. (5) The center will retain QAPI program meeting documentation onsite for a minimum of three years. (6) At each QAPI program meeting, the following must be reviewed and discussed, with documentation of discussion: (a) any patient or staff incidents that occurred since either the initial center licensing or the last QAPI meeting; (b) all treatments provided since the later of the initial center licensing or the last QAPI meeting, that had adverse side effects; (c) all patient grievances that have been received since the later of the initial center licensing or the last QAPI meeting; (i) the QAPI program will ensure that the center’s policy is followed in response to the grievance; (d) address clinical and administrative issues as well as patient outcomes; (e) any unresolved matters that were discussed or reviewed at the previous QAPI meeting; and (f) a review of adverse event data as reported under ARM 37.106.3317.