Home Table of Contents

§ 1711. Quality Assurance Programs.


Barclays Official California Code of Regulations Currentness
Title 16. Professional and Vocational Regulations
Division 17. California State Board of Pharmacy
Article 2. Pharmacies (Refs & Annos)
16 CCR § 1711
§ 1711. Quality Assurance Programs.
(a) Each pharmacy shall establish or participate in an established quality assurance program that documents and assesses medication errors to determine cause and an appropriate response as part of a mission to improve the quality of pharmacy service and prevent errors.
(b) For purposes of this section, “medication error” means any variation from a prescription or drug order not authorized by the prescriber, as described in Section 1716. Medication error, as defined in the section, does not include any variation that is corrected prior to furnishing the drug to the patient or patient's agent or any variation allowed by law.
(c)(1) Each quality assurance program shall be managed in accordance with written policies and procedures maintained in the pharmacy in an immediately retrievable form.
(2) When a pharmacist determines that a medication error has occurred, a pharmacist shall as soon as possible:
(A) Communicate to the patient or the patient's agent the fact that a medication error has occurred and the steps required to avoid injury or mitigate the error.
(B) Communicate to the prescriber the fact that a medication error has occurred.
(3) The communication requirement in paragraph (2) of this subdivision shall only apply to medication errors if the drug was administered to or by the patient, or if the medication error resulted in a clinically significant delay in therapy.
(4) If a pharmacist is notified of a prescription error by the patient, the patient's agent, or a prescriber, the pharmacist is not required to communicate with that individual as required in paragraph (2) of this subdivision.
(d) Each pharmacy shall use the findings of its quality assurance program to develop pharmacy systems and workflow processes designed to prevent medication errors. An investigation of each medication error shall commence as soon as is reasonably possible, but no later than 2 business days from the date the medication error is discovered. All medication errors discovered shall be subject to a quality assurance review.
(e) The primary purpose of the quality assurance review shall be to advance error prevention by analyzing, individually and collectively, investigative and other pertinent data collected in response to a medication error to assess the cause and any contributing factors such as system or process failures. A record of the quality assurance review shall be immediately retrievable in the pharmacy. The record shall contain at least the following:
(1) The date, location, and participants in the quality assurance review;
(2) The pertinent data and other information relating to the medication error(s) reviewed and documentation of any patient contact required by subdivision (c);
(3) The findings and determinations generated by the quality assurance review; and,
(4) Recommend changes to pharmacy policy, procedure, systems, or processes, if any.
The pharmacy shall inform pharmacy personnel of changes to pharmacy policy, procedure, systems, or processes made as a result of recommendations generated in the quality assurance program.
(f) The record of the quality assurance review, as provided in subdivision (e) shall be immediately retrievable in the pharmacy for at least one year from the date the record was created. Any quality assurance record related to the use of a licensed automated drug delivery system must also be submitted to the board within 30 days of completion of the quality assurance review and any facility with an unlicensed automated drug delivery system must report the quality assurance review to the Board at the time of annual renewal of the facility license.
(g) The pharmacy's compliance with this section will be considered by the board as a mitigating factor in the investigation and evaluation of a medication error.
(h) Nothing in this section shall be construed to prevent a pharmacy from contracting or otherwise arranging for the provision of personnel or other resources, by a third party or administrative offices, with such
skill or expertise as the pharmacy believes to be necessary to satisfy the requirements of this section.
Note: Authority cited: Section 4005, Business and Professions Code; and Section 2 of Chapter 677, Statutes of 2000. Reference: Sections 4125 and 4427.7, Business and Professions Code.
1. New section filed 1-14-2002; operative 1-14-2002 pursuant to Government Code section 11343.4 (Register 2002, No. 3). For prior history, see Register 96, No. 5.
2. Repealer of subsections (c) and (i) and new subsections (c)-(c)(4) filed 9-22-2004; operative 10-22-2004 (Register 2004, No. 39).
3. Amendment of subsections (a), (e)(1)-(4) and (f) and amendment of Note filed 5-19-2021; operative 7-1-2021 (Register 2021, No. 21).
This database is current through 5/6/22 Register 2022, No. 18
16 CCR § 1711, 16 CA ADC § 1711
End of Document