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USP Chapter 797 Sterile Compounding Changes Part III
October brings a change of seasons and a renewed focus on Patient Safety. Discharge Planning Part III and 797 Changes Part III are both geared to keeping our patients safe as current evidence changes processes to assure safe medication compounding and reinforces the need for thorough assessment and reassessment as we evaluate a patient's discharge planning needs. As you review these changes, send us your questions to
info@courtemanche-assocs.com and we'll follow-up with answers.
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Change on the Horizon: USP Chapter 797 Sterile Compounding Changes Series - Part III
Note the implementation date of USP 797 has been postponed and changes to the processes may occur as a result.
Part III of our series on the 2019 USP 797 Chapter changes
is focused on Beyond Use Dating, Record Keeping and Standard Operating Procedures.
Beyond Use Dating (BUD)
The assignment of a Beyond Use Date (BUD) or Time takes into consideration the chemical and physical stability of the medication compound and the sterility or risk of microbial contamination of the medication product. This is based upon the safeguards implemented during the compounding process, storage conditions, aseptic processing and whether sterile ingredients are used as a starting point in the compounding process. In the original USP Chapter 797, the foundation of assigning BUD categories were based upon the complexity of the compounding process. This resulted in three risk categories: Low, Medium and High. The assignment of the category was founded in the thought that the more ingredients and manipulations involved, the greater the risk of contamination and hence the shorter the BUD that was assigned.
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About the Author -
Pat Cook is a Senior Consultant and Director of Administrative Services at Courtemanche & Associates.
A Registered Pharmacist, Pat has nearly four decades of healthcare administrative and regulatory experience. With her extensive healthcare background, Pat serves as a knowledgeable resource to new and existing clients, helping to guide them through their accreditation and regulatory needs. Read more about Pat and our team.
"Pat was friendly and informative. Her direction and findings will help us with our up coming Survey." Melissa Sparks, Ascension Genesys Hospital
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Discharge Planning Beyond the Day of Discharge
Part II
The Discharge Planning process and actual Discharge Plan have often been overlooked or at least have become one of those processes that most staff just go through the motions on. Surveyors are digging deep into these processes to ensure that patients truly understand the discharge plan and have received appropriate planning activities to meet their ongoing needs. The deficiency most often cited is one where an organization cannot provide a Discharge Plan in a written format that includes: assessment, reassessments, criteria used for assessments, discharge instructions that are legible, culturally sensitive, in a language the patient prefers and is specific to the level of care they are receiving (LTC, Home Health, etc.).
CMS surveyors utilize a
worksheet as a tool to determine compliance with discharge planning activities within an acute care facility. Compliance is based on many factors within the Condition of Participation and associated standards. The CMS Condition of Participation (CoP) can be found at
§482.43 Condition of Participation: Discharge Planning.
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About the Author -
James Ballard is an Associate Consultant with over 30 years of experience responsible for assessing healthcare organizations' readiness for licensing, accreditation and regulatory compliance.
He has worked in a variety of healthcare positions and his experiences range from Surgical Technologist, EMT, Combat Medicine to a Federally Certified Healthcare Surveyor (Hospital, Critical Access, Transplant, Ambulatory Survey Centers and Long-Term Care), to Director positions over Compliance, Quality, Infection Prevention, Safety, Risk Management, Employee Health, and Emergency Preparedness. Mr. Ballard was the main creator of the CMS Focused Quality Assessment and Performance Improvement (FQAPI) Survey process and tool for Transplant programs in Hospitals. Read more about James and our team.
"James took the time to ask in-depth questions and educated us on CMS regulations to help better prepare our organization moving forward. He shared tools for us to use as well as insight of next steps moving forward. We all really enjoyed his expertise and feedback to improve our organization."
Gwynn Holland, Porter Adventist Hospital
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SAVE THE DATE!
C&A's Fall Webinar
"TJC & CMS; What's Next"
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C&A at NAHQ
Chris Pratt, MS, RN represented Courtemanche & Associates at NAHQ Next, the 2019 Annual Conference in Phoenix, Arizona.
Chris commented, " I loved the NAHQ Scavenger Hunt and met many of the attendees as they pursued the trail. What a wonderful way to share information and learn more about the participants and the vendors who attended!"
And the C&A Tote bags were a huge hit!
Chris' next stop will be in Raleigh at the Southern Atlantic Healthcare Alliance (SAHA)
Alliance Day Conference, October 8, 2019. Hope to see you there!
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Need help keeping up with every changing policies & procedures?
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Annual membership includes 12 packages that focus on top scoring & problematic topics and each contains a minimum of 3 tools:
- Policies & Procedures
- Tracers
- Checklists
- Competencies
- Risk Assessments
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Hot topics addressed so far this year:
- Suicide Risk Identification & Mitigation
- Contracting Care Services
- Moderate Sedation
- Victim Abuse
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- High Level Disinfection
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September's tips and tools will focus on
Patient Rights and the Management of Complaints and Grievances.
Join your industry colleagues that are enjoying
C_APPS.
- "Great tools - very user friendly and very useful"
- "I like the fact that you provide the policy, tracer and competency for one focused topic"
- ..."The checklists are very helpful"
For additional information, click here or email info@courtemanche-assocs.com
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The Joint Commission® is a registered trademark of Joint Commission on Accreditation of Healthcare Organizations. Courtemanche & Associates has no affiliation with this entity.
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