Mind the Gaps: Assessing Your Institution’s Compliance with USP Chapter <797>
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ACPE Activity Number: 0204-0000-24-402-H07-P/T |
Activity Overview
Health systems have worked diligently to ensure that they are in compliance with the revised USP Chapter <797> requirements. This educational activity will summarize key revisions to the revised chapter as well as review how to assess facility and personnel, policy and procedure development and review, beyond-use dating, environmental monitoring, and accreditation gaps. Best practices for training and monitoring personnel will also be presented.
*Please note, this activity was presented live as a live webinar on 3/20/24. You can only claim credit once for this activity; live or home study.
More in this Series:
On-Demand Webinar: Elevating Compliance: Navigating USP <797> with Technology and Standardization
Engaging the Experts Podcasts: Compliance with USP Chapter <797> in Small and Rural Hospitals
Frontline Conversations: Frontline Conversations: Enhancing Compliance with USP Chapter <797> in Small and Rural Hospitals;
Frontline Conversations: Targeting Compliance Gaps with USP Chapter <797>Accreditation
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education with Commendation.
Target Audience
This activity was planned to meet the educational needs of pharmacists, pharmacy technicians, and medication safety officers practicing in hospitals and health systems.
Learning Objectives
At the conclusion of this activity, participants should be able to:
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Summarize key revisions to USP Chapter <797>, including the types and frequency of baseline and ongoing testing.
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Assess facility, personnel, policy and procedure development and review, environmental monitoring, and accreditation gaps.
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Apply best practices for training and evaluating personnel, particularly the designated person(s).
Schedule of Activities
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Introduction and Announcements
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Presentation
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Questions, Answers, and Discussion
Faculty
Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, Activity Chair
Director, Accreditation and Medication Safety
Cardinal Health
Wilkes-Barre, Pennsylvania
Patricia Kienle is Director of Accreditation and Medication Safety for Cardinal Health. She received her pharmacy degree from Philadelphia College of Pharmacy and Science and a Master in Public Administration degree from Marywood University in Scranton, Pennsylvania. She is author of The Chapter <795> Answer Book, The Chapter <797> Answer Book, and The Chapter <800> Answer Book and co-author of Meeting Accreditation Standards: A Pharmacy Preparation Guide. With over 600 invited presentations and 100 publications, she has special interests in medication safety, compounding sterile preparations, accreditation, and regulatory issues.
Glen J. Gard, CPhT-Adv, CSPT, FNHIA
National Director, Sterile Compounding & Pharmacy Compliance
Option Care Health
Chicago, Illinois
Glen Gard is the national director of compounding & pharmacy compliance for Option Care Health and is a member of the State of Illinois Board of Pharmacy. Mr. Gard is an inaugural member of the PTCB’s CSPT exam development committee. He is an active member of ASHP having served as the chair of the Pharmacy Technician Forum Executive Committee and is a current member of the Education and Workforce Development Committee. Additionally, Mr. Gard has been an active member of NHIA and currently serves as Vice Chair of the Sterile Compounding Practice Committee.
Abby Roth, CMQ/OE
Microbiologist
Pure Microbiology
Allentown, Pennsylvania
Abby Roth, founder of Pure Microbiology, has been supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries since 2004. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.
Relevant Financial Relationship Disclosures
In accordance with our accreditor’s Standards of Integrity and Independence in Accredited Continuing Education, ASHP requires that all individuals in control of content disclose all financial relationships with ineligible companies. An individual has a relevant financial relationship if they have had a financial relationship with an ineligible company in any dollar amount in the past 24 months and the educational content that the individual controls is related to the business lines or products of the ineligible company.
An ineligible company is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The presence or absence of relevant financial relationships will be disclosed to the activity audience. The following persons in control of this activity’s content have relevant financial relationships:
- Patricia C. Kienle: BD – Speaker’s Bureau
All other persons in control of content do not have any relevant financial relationships with an ineligible company. As defined by the Standards of Integrity and Independence in Accredited Continuing Education definition of ineligible company. All relevant financial relationships have been mitigated prior to the CE activity.
Methods and CE Requirements
Claim CE Within 60 Days
To receive CE credit, complete the steps below within 60 days of completing the activity.
- View the entire presentation and answer all polling questions.
- Click "Complete Activity" on last slide then complete the evaluation to claim credit.
- Verify credits were successfully transferred to CPE Monitor before the ACPE 60-day deadline by checking your NABP eProfile account.
Important Note – ACPE 60 Day Deadline
Provided by ASHP
Supported by an educational grant from Pfizer Inc.