ENSURING YOUR PRACTICE IS USP 800 COMPLIANT

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Presentation transcript:

ENSURING YOUR PRACTICE IS USP 800 COMPLIANT John Dodd, CMPE Director, Business Optimization and Clinical Consulting

Agenda Acronyms Why USP 800? Benefits of USP 800 Challenges of USP 800 How to make USP 800 work for your Patients and your Practice

Acronyms There are 30 acronyms in USP 800. Examples: BSC – Biological Safety Cabinet (Hood) CACI – Compounding Aseptic Containment Isolator (Hood with gloves) C-SCA – Containment Segregated Compounding Area (Negative Pressure Room) Other confusing factors – USP 795 – 797 - 800

Why USP 800? History Studies began in the last 1970s Federal Government Involvement OSHA published the first set of guidelines in 1986 for the handling of antineoplastic drugs They followed that up with the publication of the Hazard Communication Standard concerning all hazardous drugs in 1994, revised in 2014 NIOSH publishes the tables that lay out the hazardous drugs based on specific criteria (Currently in revision) USP 800 - Published in February 2016 but pending enforcement until December 1, 2019 Patient and Staff Safety

Benefits of USP 800 Safety – Patient and Staff Protection Training Enforcement

Challenges of USP 800 Cost Space Documentation Training New requirements on PPE, CSTDs, negative pressure room, etc. Enforcement Inspections Unknowns

How to make USP 800 work for your patients and your practice Understand the requirements Appoint an HDDP that will be your Champion Practice leadership has to step up and embrace the program Use available ION resources

USP 800 Consulting Offering USP 800 Gap/Risk Analysis Three part offering 14 Question Questionnaire Onsite Visit Written report For more information on this, contact: John.Dodd@ionline.com Phone: 239-410-0755