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(4) Quality assurance. (a) A minimum of 5% of each delegates product verifications shall be audited by a licensed pharmacist. The accuracy of each delegate shall be tracked individually.
(b) A record of each delegate-check-delegate audit shall include all of the following:
  1. Name of the product verification delegate.
  2. Total number of product verifications performed.
  3. Number of product verifications audited by the pharmacist.
  4. Percentage of product verifications audited by pharmacist.
  5. Percentage of accuracy.
  6. Number of product verification errors identified.
  7. Type of error under sub. (2) (c) 2.
(c) On a quarterly basis, the supervising pharmacist shall perform an assessment of each delegate’s previous 12 months accuracy and correctness of delegate-check-delegate product verifications including a review of the quality assurance log.
(d) A delegate shall be revalidated if the delegate fails to maintain a product verification accuracy rate of 99.8% based on the quarterly assessment of the previous 12 months or has not performed delegate-check-delegate product verifications within the last 6 months.
(5) Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the delegate-check-delegate which shall be made available to the board upon request.
(6) Records. (a) Each pharmacy shall maintain for 5 years the following records:
  1. All validation records of each delegate that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.
  2. Documentation indicating accepting responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising delegate-check-delegate pharmacist, indicating the name of the supervising delegate-check-delegate pharmacist, and the dates the supervision responsibilities begin and end.
  3. Quality assurance audits and quarterly assessments.
(b) Records shall be made available to the board upon request.
Section 2. EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats.
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Dated   October 23, 2019     Agency
              Chair of the Pharmacy Examining Board
             
             
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