Section 657.9.16. Centralized unit dose AMDS.

The quality assurance plan shall provide for pharmacist verification of all drug doses dispensed for a minimum of 60 days following implementation of the AMDS.

         9.16(1) Errors logged. All identified errors shall be logged as provided by the quality assurance and monitoring plan developed pursuant to rule 9.10(147,155A) and shall be categorized as follows:

            a.               Computer order entry error;

            b.               Incorrect drug;

            c.               Incorrect dose;

            d.               Incorrect quantity — extra dose(s);

            e.               Incorrect quantity — short dose(s);

            f.                Incorrect dosage form;

            g.               Other errors. All errors categorized as “other errors” shall include additional notation identifying the error.

         9.16(2) Initial report to the board. The first quarterly report to the board shall summarize identified errors by category and shall include the total number of errors identified, the reasons for the errors, the corrective actions taken to prevent the recurrence of those errors, and the average accuracy (correct doses over total doses) determined for all AMDS-dispensed drugs during the first quarter following implementation.

         9.16(3) Random verification. If the average accuracy of the AMDS during the initial 60-day period is at least 99.7 percent for all drug doses dispensed, the quality assurance plan shall provide for random verification by a pharmacist. The plan shall provide that 5 percent of all drug doses dispensed daily utilizing the AMDS be verified by a pharmacist, or it shall provide that 100 percent of all drug doses dispensed on a specific day each month be verified by a pharmacist. A pharmacy may petition the board pursuant to 657—Chapter 34 for a variance for an alternate pharmacist verification process. Errors shall continue to be identified and logged as provided by the quality assurance and monitoring plan developed pursuant to rule 9.10(147,155A) and shall be categorized as provided in subrule 9.16(1).

If the average accuracy of the AMDS during the initial 60-day period is not at least 99.7 percent for all drug doses dispensed, the pharmacy shall continue pharmacist verification of all drug doses dispensed utilizing the AMDS until the average accuracy for 60 consecutive days is at least 99.7 percent.

         9.16(4) Reports during first year. For a minimum of one year following implementation of the AMDS, written quarterly reports shall be submitted to the board. Reports shall summarize identified errors by category and shall include the total number of errors identified, the reasons for the errors, the corrective actions taken to prevent the recurrence of those errors, and the average accuracy (correct doses over total verified doses) for all drug doses verified during the preceding quarter.

         9.16(5) Accuracy. Any random verification disclosing accuracy of less than 99.7 percent for all drug doses verified shall require that a pharmacist again verify all drug doses dispensed utilizing the AMDS until the average accuracy equals or exceeds 99.7 percent for all drug doses dispensed for three consecutive days.

         9.16(6) Continued verification. The quality assurance plan shall provide for continuation, as long as the pharmacy utilizes the AMDS, of random verification by the pharmacist of AMDS-dispensed drug doses as provided in subrules 9.16(3) and 9.16(5).

         9.16(7) Reports after one year. Following the one-year period and within 30 days of determining by random verification that the accuracy of AMDS drug fills is less than 99.7 percent for all drug doses verified, a written report shall be submitted to the board. The report shall summarize the identified errors by category and shall include the reasons for the errors, the corrective actions taken to prevent the recurrence of those errors, and the low accuracy rate prompting the report.