Monday, June 10, 2019 Boston, Massachusetts A Promotional Theater conducted at the 2019 ASHP Summer Meetings and Exhibition This Promotional Theater is planned by ASHP Advantage and sponsored by Fresenius Kabi Strategies for Ensuring Compliance by the December 2019 Deadline www.ashpadvantage.com/uspchanges USP Chapter <797> UPDATE ON USP CHAPTER <797> AGENDA 6:00 – 6:30 p.m. Buffet Dinner 6:30 – 6:55 p.m. Overview of Changes to USP Chapter <797> Patricia C. Kienle, B.S.Pharm., M.P.A, FASHP 6:55 – 7:20 p.m. Employing Changes to USP Chapter <797>: Is Your Facility Ready? Eric S. Kastango, B.S.Pharm., M.B.A., FASHP 7:20 – 7:45 p.m. Practical Approaches to Attaining Compliance with USP Chapter <797>: One Health System’s Experience Ashley Duty, Pharm.D., M.S. 7:45 – 8:30 p.m. Strategies for Ensuring Compliance with USP Chapter <797>: Faculty Discussion and Audience Questions All Faculty
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Monday, June 10, 2019Boston, Massachusetts
A Promotional Theater conducted at the 2019 ASHP Summer Meetings and Exhibition
This Promotional Theater is planned by ASHP Advantage and sponsored by Fresenius Kabi
Strategies for Ensuring Compliance by the December 2019 Deadline
www.ashpadvantage.com/uspchanges
USPChapter<797>
UPDATE ON USP CHAPTER <797>
AGENDA6:00 – 6:30 p.m.Buffet Dinner
6:30 – 6:55 p.m.Overview of Changes to USP Chapter <797>Patricia C. Kienle, B.S.Pharm., M.P.A, FASHP
6:55 – 7:20 p.m.Employing Changes to USP Chapter <797>: Is Your Facility Ready?Eric S. Kastango, B.S.Pharm., M.B.A., FASHP
7:20 – 7:45 p.m.Practical Approaches to Attaining Compliance with USP Chapter <797>: One Health System’s ExperienceAshley Duty, Pharm.D., M.S.
7:45 – 8:30 p.m.Strategies for Ensuring Compliance with USP Chapter <797>: Faculty Discussion and Audience Questions All Faculty
Patricia C. Kienle, B.S.Pharm., M.P.A, FASHPDirector, Accreditation and Medication SafetyCardinal Health Innovative Delivery SolutionsWilkes‐Barre, Pennsylvania
Eric S. Kastango, B.S.Pharm., M.B.A., FASHPPresident and CEOClinical IQ, LLC and CriticalPoint, LLCMadison, New Jersey
This Promotional Theater is planned by ASHP Advantage and sponsored by Fresenius Kabi
In accordance with ACCME and ACPE Standards for Commercial Support, ASHP policy requires that all faculty, planners, reviewers, staff, and others in a position to control the content of this presentation disclose their financial relationships. In this activity, only the individual below has disclosed a relevant financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships.• Eric Kastango
– CriticalPoint, LLC: stockholder/ownership interest– Wolter Kluwer: royalties
• Patricia C. Kienle– Cardinal Health: employee– CriticalPoint, LLC: consultant
Disclosures
Please be advised that this activity is being audio and/or video recorded for archival purposes and, in some cases, for repurposing of the content for enduring materials.
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
At the conclusion of this activity, participants should be able to• Describe the primary changes to USP Chapter <797> that
will be official on December 1, 2019• Identify best practices for ensuring safety of sterile
products within a health system• Compare current operations with revised USP Chapter
<797> standards• Develop a plan for making changes to attain compliance
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
• As long as …– For a single patient– Will not be stored
Centers for Disease Control and Prevention. Safe injection practices to prevent transmission of infections to patients. https://www.cdc.gov/injectionsafety/ip07_standardprecaution.html
(accessed 2019 May 20).
Administering is not Compounding
What type of facility do you have? Select all that apply.
a. Cleanroom suite: anteroom + buffer roomb. Combined ante/buffer roomc. Segregated compounding aread. No compliant facility – immediate use preparation
onlye. Don’t know or not at a site that prepares CSPs
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
• Type and placement of primary engineering control• Sink placement• Visible lines of demarcation and doffing• HEPA‐filtered ceiling air• Ability to access ceiling• Control of doors• Temperature, humidity, and pressure monitors• Calibration of equipment
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
• Policies and procedures• BUDs• Documentation of personnel training• Frequency of personnel monitoring• Frequency of surface sampling• Plan for reaction to out‐of‐specification results
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
Facility Requirements
Category 1 = Cleanroom Suite or SCA
Category 2 = Cleanroom Suite
CAI or CACI (now called a Restricted Access Barrier System or RABS) must be placed in cleanroom suite to get BUDs greater than 12 hours room temperature and 24 hours refrigerated!
RABS not treated differently than BSCs or LAFS
Category 1: PEC or C‐PEC inside SCA or C‐SCA
• BUD– 12 hours or less at controlled room
temperature– 24 hours or less when refrigerated
• Only if made in accordance with applicablerequirements for Category 1 CSPs
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
• USP Chapter <797> (2008) allowed CAIs and CACIs(now RABS) with the default BUDs in the chapter– This allowance will no longer be compliant with thestandard on Dec 1, 2019
• All hospitals will be challenged by this new paradigm• Alternative strategies like RTU, proprietary vial‐bagsystems and staffing increases must be evaluated
Impact of Category 1
RTU = ready‐to‐use
• BUD– Greater than 12 hours at controlled
room temperature– Greater than 24 hours when
refrigerated• Sterility and endotoxin testing
based on BUD assigned• Only if made in accordance with
applicable requirements forCategory 2 CSPs
Category 2: PEC or C‐PEC in Buffer Room with Anteroom
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
• Highly controversial part of certification• Chapter <797> only prescribes minimum ACPH based on HEPA‐
filtered supply air except for C‐SCA (based on exhaust)• ACPH often needs to be higher to maintain a state of control• Factors affecting needed ACPH
– Number of personnel in the area– Number of particulates generated from processes in the area– Equipment located in the room– Room air pressure– Temperature
Air Exchanges
Air Change SpecificsISO Class 7 ISO Class 8
• ≥20 ACPH• Clarified because current chapter
does not specify anteroom ACPH– This is from FDA Aseptic Processing
Guidance• All ACPH must be supplied from
the HVAC through HEPA filterslocated in the ceiling
• Certification report mustdocument total ACPH
• ≥30 ACPH• ≥15 ACPH of the total air changes
must come from the HVAC throughHEPA filters located in the ceiling
• If the PEC is used to meet theminimum total ACPHs required, thePEC must not be turned off exceptfor maintenance
• Certification report must include theACPH from HVAC, ACPH contributedfrom the PEC, and the total ACPH
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
Personnel Qualifications: Same for Category 1 and Category 2
Requirement Frequency
Visual observation of hand hygiene and garbing Every 6 monthsGloved fingertip and thumb sampling Every 6 monthsMedia fill testing Every 6 monthsRequalification Every 12 months
Training is required every 12 months in appropriate sterile compounding principles and practices
• Training is not just for compounding staff• Needed for other personnel handling CSPs or accessing the compounding area• Must demonstrate competency in proper behavior to maintain the
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
• Failure of any of the following will require successfulreevaluation before personnel can resume compounding– Hand hygiene/garbing– Aseptic technique– GFS– Media fill testing
• How will this affect your ability to care for patients if youneed to wait 14 days for media fill results?
Reevaluation, Retraining, Requalification
• The USP Chapter <797> revisions clarified several key facility‐relateddesign and performance elements along with certificationrequirements
• The use of CAI or CACI (RABS) offer no advantage over “open‐front”primary engineering controls or allow for the default BUDs in the USPChapter <797>
• All hospitals will need to reevaluate their strategies for compoundingand dispensing CSPs due to shortened BUDs in facilities with a Category1 operation
• Use and location of HEPA filters in the HVAC system should be accessed
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
• Operating room SCA– Medications are used within 2‐3 hours– Limited number of medications and manipulations– Access to operating room space is already limitedand laundered scrubs are required
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
Which of the following types of systems does your health system use for tracking personnel competencies and viable air sampling? Select all that apply.
a. Paper or electronic formsb. Electronic spreadsheetsc. Internal websited. External subscription websitee. N/A or unsure
Online Personnel Recordkeeping
• Advantages– Consistent– Reminders– Customized assignments– Hard to misplace or lose
• Disadvantages– Cost– Need for contracting– Ease of retrieval– Interconnectivity withhuman resourcesrequirements
Update on USP Chapter <797>: Strategies for Ensuring Compliance by the December 2019 Deadline
Patricia C. Kienle, Activity Chair B.S.Pharm, M.P.A., FASHP
Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions Wilkes-Barre, Pennsylvania
Patricia C. Kienle, B.S.Pharm., M.P.A, FASHP, is Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions. 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 completed an Executive Fellowship in Patient Safety from Virginia Commonwealth University and is Adjunct Associate Professor at Wilkes University in Wilkes-Barre, Pennsylvania.
Ms. Kienle has served on the ASHP Board of Directors and as President of the Pennsylvania Society of Health-System Pharmacists. She is a Fellow of ASHP and has been honored with the ASHP Distinguished Leadership Award and 2018 ASHP John W. Webb Lecture Award. Ms. Kienle has served on the Pharmacotherapy Specialty Council of the Board of Pharmacy Specialties, Pennsylvania Patient Safety Authority, Hospital Professional and Technical Advisory Committee of The Joint Commission, and Board of Governors of the National Patient Safety Foundation. She is a member of the USP Compounding Expert Committee and chairs the Subcommittee on Hazardous Drugs.
Ms. Kienle is co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide, and author of The Chapter <800> Answer Book. With over 500 invited presentations and 50 publications, she has special interests in medication safety, compounding sterile preparations, accreditation, and regulatory issues.
Ashley M. Duty Pharm.D., M.S.
Clinical Pharmacy Operations Manager Children’s Mercy Kansas City, Missouri
Ashley Duty, Pharm.D., M.S., is Clinical Pharmacy Operations Manager at Children’s Mercy in Kansas City, Missouri. She earned a Doctor of Pharmacy degree from the Raabe Col-
lege of Pharmacy at Ohio Northern University and a Master of Science in Health-System Pharmacy Adminis-tration degree from Northeast Ohio Medical University. She completed an ASHP-accredited PGY1/PGY2 Health-System Pharmacy Administration residency at Cleveland Clinic in 2014.
At Children’s Mercy, Dr. Duty is responsible for 21 pharmacists in general medicine and hematology/oncology, as well as for USP Chap-ter <797> and USP Chapter <800> oversight for all sterile compounding operations. She also serves as the staffing preceptor for the accredited PGY1 and PGY2 residencies.
Dr. Duty’s professional interests include operations, medication safety, and informatics. She is also very passionate about leadership development. Within ASHP, she is a member of the Educational Steering Committee for the Section of Phar-macy Practice Managers. Previously she served as Chair and Vice Chair of the New Practitioners Forum. On the local level, Dr. Duty is Programs Chair for the Greater Kansas City Society of Health-System Pharmacists.
Dr. Duty completed the ASHP Advanced Sterile Product Prepara-tion Certificate in 2017 and served as a planner and presenter for both the PTCB-recognized ASHP Sterile Product Preparation Certificate and the Compounded Sterile Products Certificate for Pharmacists in 2019.
Eric S. Kastango B.S.Pharm., M.B.A., FASHP
President and CEO Clinical IQ, LLC and CriticalPoint, LLC Madison, New Jersey
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP, is President and CEO of Clinical IQ LLC, a health-care consulting firm, and CriticalPoint, LLC, a web-based education company.
Mr. Kastango received a Bachelor of Sci-ence degree in pharmacy from Massa-chusetts College of Pharmacy and Allied Health Sciences and a Master of Business Administration degree from University of Phoenix. He completed 65 hours of training in nuclear pharmacy at Purdue University and 80 hours of didactic train-ing for the Six Sigma-Green Belt certifi-cation that he started with BD Medical Systems. At Johns Hopkins Bloomberg School of Public Health, he is working on a Certificate in Quality, Patient Safety, and Outcomes Research.
Mr. Kastango served on the USP Sterile Compounding Committee from 2005-2010 and 2010–2015 USP Council of Ex-perts, Compounding Expert Committee until April 2013. In May 2013, USP recog-nized Mr. Kastango and the members of Compounding Expert Committee with an Award for Outstanding Contribution to the USP Standards-Setting Process. He received an ISMP Cheers Award in 2015 for his work related to sterile compound-ing safety. Mr. Kastango also served on the USP Hazardous Drug Expert Panel from 2010–2016, and he is actively working with NABP and state boards of pharmacy to provide training to their sterile compounding inspectors.
Mr. Kastango is an active member and Fellow of ASHP, and he served on the Expert Panel for the ASHP Research and Education Foundation in the develop-ment of the 2015 Outsourcing Sterile Products Preparation Vendor Assessment Tool and ASHP’s Insourcing Readiness Assessment Tool.
n Engaging the Experts—faculty discussions with William Zellmer
n Promotional Theater On Demand—proceedings of today’s session
About Promotional TheatersThis Promotional Theater, conducted at the ASHP 2019 Summer Meetings and Exhibition, is a promotional activity provided by Fresenius Kabi and is not certified for continuing education credit. The content of this Promotional Theater and opinions expressed by presenters are those of the sponsor or presenters and not of the American Society of Health-System Pharmacists.
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