Section 657.8.26. Continuous quality improvement program.

Pursuant to rule 657—8.3(155A), each pharmacy licensed to provide pharmaceutical services to patients in Iowa shall implement or participate in a continuous quality improvement program (CQI program). The CQI program is intended to be an ongoing, systematic program of standards and procedures to detect, identify, evaluate, and prevent medication errors, thereby improving medication therapy and the quality of patient care. A pharmacy that participates as an active member of a hospital or corporate CQI program that meets the objectives of this rule shall not be required to implement a new program pursuant to this rule.

         8.26(1) Reportable program events. For purposes of this rule, a reportable program event or program event means a preventable medication error resulting in the incorrect dispensing of a prescribed drug received by or administered to the patient and includes but is not necessarily limited to:

            a.               An incorrect drug;

            b.               An incorrect drug strength;

            c.               An incorrect dosage form;

            d.               A drug received by the wrong patient;

            e.               Inadequate or incorrect packaging, labeling, or directions; or

            f.                Any incident related to a prescription dispensed to a patient that results in or has the potential to result in serious harm to the patient.

         8.26(2) Responsibility. The pharmacist in charge may delegate program administration and monitoring, but the pharmacist in charge maintains ultimate responsibility for the validity and consistency of program activities.

         8.26(3) Policies and procedures. Pursuant to rule 657—8.3(155A), each pharmacy shall have written policies and procedures for the operation and management of the pharmacy’s CQI program. A copy of the pharmacy’s CQI program description and policies and procedures shall be maintained and readily available to all pharmacy personnel. The policies and procedures shall address, at a minimum, a planned process to:

            a.               Train all pharmacy personnel in relevant phases of the CQI program;

            b.               Identify and document reportable program events;

            c.               Minimize the impact of reportable program events on patients;

            d.               Analyze data collected to assess the causes and any contributing factors relating to reportable program events;

            e.               Use the findings to formulate an appropriate response and to develop pharmacy systems and workflow processes designed to prevent and reduce reportable program events; and

            f.                Periodically, but at least annually, meet with appropriate pharmacy personnel to review findings and inform personnel of changes that have been made to pharmacy policies, procedures, systems, or processes as a result of CQI program findings.

         8.26(4) Event discovery and notification. As provided by the procedures of the CQI program, the pharmacist in charge or appropriate designee shall be informed of and review all reported and documented program events. All pharmacy personnel shall be trained to immediately inform the pharmacist on duty of any discovered or suspected program event. When the pharmacist on duty determines that a reportable program event has occurred, the pharmacist shall ensure that all reasonably necessary steps are taken to remedy any problems or potential problems for the patient and that those steps are documented. Necessary steps include, but are not limited to, the following:

            a.               Notifying the patient or the patient’s caregiver and the prescriber or other members of the patient’s health care team as warranted;

            b.               Identifying and communicating directions or processes for correcting the error; and

            c.               Communicating instructions for minimizing any negative impact on the patient.

         8.26(5) CQI program records. All CQI program records shall be maintained on site at the pharmacy or shall be accessible at the pharmacy and be available for inspection and copying by the board or its representative for at least two years from the date of the record. When a reportable program event occurs or is suspected to have occurred, the program event shall be documented in a written or electronic storage record created solely for that purpose. Records of program events shall be maintained in an orderly manner and shall be filed chronologically by date of discovery.

            a.               The program event shall initially be documented as soon as practicable but no more than three days following discovery of the event by the staff member who discovers the event or is informed of the event.

            b.               Program event documentation shall include a description of the event that provides sufficient information to permit categorization and analysis of the event and shall include:

             (1)             The date and time the program event was discovered and the name of the staff person who discovered the event; and

             (2)             The names of the individuals recording and reviewing or analyzing the program event information.

         8.26(6) Program event analysis and response. The pharmacist in charge or designee shall review each reportable program event and determine if follow-up is necessary. When appropriate, information and data collected and documented shall be analyzed, individually and collectively, to assess the cause and any factors contributing to the program event. The analysis may include, but is not limited to, the following:

            a.               A consideration of the effects on the quality of the pharmacy system related to workflow processes, technology utilization and support, personnel training, and both professional and technical staffing levels;

            b.              Any recommendations for remedial changes to pharmacy policies, procedures, systems, or processes; and

            c.               The development of a set of indicators that a pharmacy will utilize to measure its program standards over a designated period of time.

[ARC 1961C, IAB 4/15/15, effective 5/20/15; ARC 2413C, IAB 2/17/16, effective 3/23/16]