Health Care Department Operations Manual

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Chapter 3 – Health Care Operations

Article 5 – Pharmacy and Medication Services

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3.5.11 Pharmacy Quality Assurance Program

  • Procedure Overview

    • Each pharmacy shall maintain a quality assurance program to document and assess pharmacy-related medication errors and shall adhere to the Health Care Department Operations Manual (HCDOM), Sections 1.2.6 and 1.2.7, Patient Safety Program; and Section 3.5.12, High Alert Medications.

  • Purpose

    • To assess errors that occur in the pharmacy in dispensing or furnishing medications so the pharmacy may take appropriate action to prevent a recurrence.

  • Responsibility

    • The Pharmacist-in-Charge (PIC) shall be responsible for maintaining a quality assurance program within the pharmacy to ensure that medication errors which are potentially attributable, in whole or in part, to the pharmacy or its personnel are assessed and addressed.

    • The Statewide Patient Safety Program is responsible for providing the PIC with access to all medication errors reported through the electronic Health Care Incident Reporting system.

  • Procedure

    • Pharmacy Medication Error Reporting

      • When a pharmacist determines that a medication error has occurred within the pharmacy which resulted in incorrect administration to the patient or self-administration by the patient or a clinically significant delay in therapy, the pharmacist shall do the following as soon as possible:

        • Ensure appropriate communication to the patient regarding the error that has occurred and the steps required to avoid injury or mitigate the error were provided.

        • Communicate to the prescriber and the appropriate nursing supervisor that a medication error has occurred.

      • Upon discovering any medication error, pharmacy staff shall report it as described in the HCDOM, Section 1.2.7, Institution Patient Safety Program.

    • Pharmacy Process Improvement Activities

      • The PIC, or pharmacist designee, shall review any medication error(s) that have been determined to potentially have occurred due, in whole or in part, to pharmacy staff and commence the investigation using the CDCR Pharmacy Error Follow-up form on the electronic Health Care Incident Report (eHCIR) system as soon as reasonably possible but no later than  two business days of pharmacy staff discovering the medication error. 

      • The Statewide Chief of Pharmacy Services shall be notified of issues identified during error review that may affect statewide processes.

      • The PIC shall use findings from the pharmacy’s quality assurance program to develop and/or improve pharmacy systems and workflow processes to prevent future errors.

      • All errors reviewed by the pharmacy quality assurance program shall be shared with the appropriate institution quality committee (e.g., Medication Management Subcommittee, Patient Safety Committee, Quality Management Committee).

    • Pharmacy Quality Assurance

      • Medication error reports are generated and maintained as a component of the pharmacy’s ongoing quality assurance program and are considered peer review documents not subject to discovery in any arbitration, civil, or other proceeding as provided under the California Business and Professions Code, Section 4125, and are therefore not part of the health record.

      • Pharmacy quality assurance review records shall be immediately retrievable in the pharmacy for a period of at least one year and shall be stored within the institution for at least three years from the date the record was created.

      • All quality assurance records, including medication error reports, involving an automated drug delivery system (ADDS) shall be filed separately from all other records pursuant to the timeframes in Section (d)(3)(B).  Any quality assurance record with an error attributable to an ADDS must also be submitted to the Board of Pharmacy within 30 days of completion of the quality assurance review.

  • References

    • California Business and Professions Code, Division 2, Chapter 9, Article 7, Section 4125

    • California Business and Professions Code, Division 2, Chapter 9, Article 25, Section 4427.7

    • California Code of Regulations, Title 16, Division 17, Article 2, Section 1711

    • California Health and Safety Code, Division 2, Chapter 2, Article 3, Section 1279.1

    • Health Care Department Operations Manual, Chapter 1, Article 2, Section 1.2.6, Statewide Patient Safety Program

    • Health Care Department Operations Manual, Chapter 1, Article 2, Section 1.2.7, Institution Patient Safety Program

    • Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.12, High Alert Medications

  • Revision History

    • Effective: 11/2007
      Revised: 12/2021
      Reviewed: 08/08/2023, 8/12/2025