# Title 61 — State Board of Pharmacy

## Article 61-02 — Pharmacies

## Chapter 61-02-09 — Continuous Quality Improvement

### § 61-02-09-01. Definitions.

In this chapter, unless the context or subject matter otherwise requires:
1. "Actively reports" means reporting all dispensing errors and analysis of such errors to a patient
safety organization as soon as practical or at least within thirty days of identifying the error.
2. "Analysis" means a review of the findings collected and documented on each dispensing error,
assessment of the cause and any factors contributing to the dispensing error, and any
recommendation for remedial action to improve pharmacy systems and workflow processes to
prevent or reduce future errors.
3. "Dispensing error" means one or more of the following discovered after the final verification by
the pharmacist:
a. Variation from the prescriber's prescription drug order, including:
(1) Incorrect drug;
(2) Incorrect drug strength;
(3) Incorrect dosage form;
(4) Incorrect patient; or
(5) Inadequate or incorrect packaging, labeling, or directions.
b. Failure to exercise professional judgments in identifying and managing:
(1) Therapeutic duplication;
(2) Drug-disease contraindications, if known;
(3) Drug-drug interactions, if known;
(4) Incorrect drug dosage or duration of drug treatment, interactions;
(5) A clinically significant, avoidable delay in therapy; or
(6) Any other significant, actual or potential problem with a patient's drug therapy.
c. Deliver of a drug to incorrect patient.
d. Variation in bulk repackaging or filling of automated devices, including:
(1) Incorrect drug;
(2) Incorrect drug strength;
(3) Incorrect dosage form; or
(4) Inadequate or incorrect packaging or labeling.

4. "Incident" means a patient safety event that reached the patient, whether or not the patient is
harmed.
5. "Near miss" means a patient safety event that did not or could not have reached the patient.
6. "Patient safety organization" means an organization that has as its primary mission continuous
quality improvement under the Patient Safety and Quality Improvement Act of 2005
(P.L. 109-41) and is credentialed by the agency for healthcare research and quality.
7. "Unsafe condition" means any circumstance that increases the probability of a patient safety
event.
History: Effective April 1, 2016.
General Authority: NDCC 28-32-02, 43-15-10, 23-34
Law Implemented: NDCC 28-32-03, 43-15-10, 23-34
### § 61-02-09-02. Continuous quality improvement program.

1. Each pharmacy permittee shall establish continuous quality improvement program for the
purpose of detecting, documenting, assessing, and preventing incidents, near misses, and
unsafe conditions.
2. A pharmacy permittee meets the requirements if the permittee meets the following:
a. Maintains and complies with the policies and procedures as noted in subsection 4;
b. The pharmacy reports incidents, near misses, and unsafe events through either:
(1) A contracted patient safety organization that is listed as an agency for health
research and quality on www.ahrq.com whose primary mission is pharmacy
continuous quality improvement; or
(2) An internal program to the pharmacy which is acceptable to the board where proper
documentation and evaluation can be completed.
3. At a minimum, a continuous quality improvement program must include provisions to:
a. Designate an individual or individuals responsible for implementing, maintaining, and
monitoring the continuous quality improvement program, which is managed in
accordance with written policies and procedures maintained in the pharmacy in an
immediately retrievable form;
b. Initiate documentation of incidents, near misses, and unsafe conditions as soon as
possible, but no more than seven days, after determining their occurrence;
4. The policies and procedures must be in compliance with this section must include:
a. Training all pharmacy personnel in relevant phases of the continuous quality
improvement program;
b. Identifying and documenting reportable incidents and near misses and unsafe events;
c. Minimizing the impact of incidents and near misses and unsafe events on patients;
d. Analyzing data collected to assess the causes and any contributing factors relating to
incidents and near misses and unsafe events;

e. Use the findings to formulate an appropriate response and to develop pharmacy systems
and workflow processes designed to prevent and reduce incidents and near misses and
unsafe events; and
f. Periodically, but at least quarterly, 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 continuous quality improvement
program findings.
5. Quality self-audit. Each pharmacy shall conduct a quality self-audit at least quarterly to
determine whether the occurrence of incidents, near misses, and unsafe conditions has
decreased and whether there has been compliance with preventative procedures, and to
develop a plan for improved adherence with the continuous quality improvement program in
the future. Each pharmacy shall conduct a quality self-audit upon change of
pharmacist-in-charge to familiarize that person with the pharmacy's continuous quality
improvement program.
6. Protection from discovery:
a. Records that are generated as a component of a pharmacy's ongoing quality assurance
program and which are maintained for that program are peer review documents and are
not subject to subpoena or discovery in an arbitration or civil proceeding.
b. Records that are generated as a component of a pharmacy's ongoing quality assurance
program and which are maintained for that program are confidential and may not be
released, distributed, or communicated in any manner, except as provided by these rules
or the permitee's policies and procedures. Recognizing the importance of sharing
information with staff, experts, consultants, and others is necessary in reducing
medication errors, information used as a part of the permitee's quality program in any
manner does not compromise the confidentiality and privilege of such information.
c. This subsection does not prohibit a patient from accessing the patient's prescription
records or affect the discoverability of any records that are not generated solely as a
component of a pharmacy's ongoing quality assurance program and maintained solely
for that program.
7. The board's regulatory oversight activities regarding a pharmacy's continuous quality
improvement program are limited to inspection of the pharmacy's continuous quality
improvement policies and procedures and enforcing the pharmacy's compliance with those
policies and procedures.
8. An analysis or summary of findings, produced within six months of submission, is evidence of
compliance with the records and data collection provisions. A permittee may not be required to
produce data, charts, error reports, or findings collected and used in compiling an analysis
summary.
9. Not withstanding subsections 6 and 8, if a pharmacy is reporting to a patient safety
organization whose primary mission is continuous quality improvement all data and records
are privileged and confidential as provided in the Patient Safety and Quality Improvement Act
of 2005 and implementing regulations.
History: Effective April 1, 2016.
General Authority: NDCC 28-32-02, 43-15-10, 23-34
Law Implemented: NDCC 28-32-03, 43-15-10, 23-34
