Each pharmacy's continuous quality improvement program shall meet the following minimum requirements:

1. (a) The pharmacist-in-charge or the pharmacist-in-charge's designee shall start reviewing each incident report within seven days, and the pharmacist-in-charge shall complete the review of each incident report within 30 days of the incident report's creation. The pharmacist-in-charge shall document and perform the following as part of the review process:

   1. (1) Communicate with each employee involved in the incident;
   2. (2) complete a root cause analysis of the incident report; and
   3. (3) create a corrective action plan for the incident.

2. (b) No later than the 15^th day of each February, April, June, August, October, and December, the pharmacist-in-charge shall create a summary and communicate the information from the summary to each licensee and registrant under the pharmacist-in-charge's supervision. The summary shall include the following information from the two previous calendar months:

   1. (1) Each type of incident reported, including each identified prescription number involved;
   2. (2) each root cause analysis completed;
   3. (3) each corrective action plan created; and

   4. (4) evaluation of the outcomes and effectiveness of each correction action plan from the monthly summaries for the previous four months.

      If the pharmacy did not have any new incident report, root cause analysis, or corrective action plan since the last summary, the pharmacist-in-charge shall create a null report. "Null report" means a report that states that the pharmacy did not have any new incident reports, root cause analyses, or corrective action plans.

3. (c) The pharmacy shall maintain a copy of each summary and null report in a readily retrievable format for a period of at least five years.
4. (d) Any pharmacy that actively reports to a patient safety organization certified by the secretary pursuant to 42 U.S.C. § 299b-24, and amendments thereto, that has a primary mission of continuous quality improvement, shall be exempt from the requirements set forth in paragraphs (a)(2), (a)(3), (b)(2), and (b)(3) of this regulation. The pharmacy shall maintain a record of the pharmacy's membership with the patient safety organization in a readily retrievable format for a period of five years.

(Authorized by and implementing K.S.A. 65-1695; effective April 10, 2009; amended Nov. 29, 2019; amended Aug. 16, 2024.)