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Jenester Crocton, PharmD, BCPS, MBA Birmingham VA Medical Center - - PowerPoint PPT Presentation
Jenester Crocton, PharmD, BCPS, MBA Birmingham VA Medical Center - - PowerPoint PPT Presentation
Jenester Crocton, PharmD, BCPS, MBA Birmingham VA Medical Center Gadsden CBOC HealthSouth Rehabilitation Hospital of Gadsden Disclosure Statement I, Jenester Crocton, have no actual or potential conflicts of interest. Objectives
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Objectives
- Describe the importance and impact of
complying with USP 797.
- List various activities that aid in compliance
with USP 797.
- Discuss action plans after receiving a negative
report and/or finding.
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History Significance
- 1970s – 1980s Nationwide bacterial
contamination of parenteral products resulting in nosocomial infections and death
- Public awareness
- Pharmacy organization responsiveness
- Publications
- Legislation
- Jan 1, 2004 the 1st version of USP Chapter 797
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Enforcing Compliance
- FDA
- State Board of Pharmacy
- The Joint Commission
- Office of Internal General
- You and I
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Garb Up! Don’t Get Caught Off Guard
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Activities to Aid in Compliance
- Be Knowledgeable of What Inspectors Look for:
- Institutional Policy and Procedures
- Training Log
- Personnel Records
- Cleaning and Environmental Logs
- Room and Hood Certifications and Past Reports
- Compounding Practices and Logs
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Activities to Aid in Compliance
- Develop SOPs
- Educate Staff
- Document, Document, Document
- Select IV coordinator
- USP 797/800 survey readiness team
- Pharmacy personnel
- Non‐Pharmacy Personnel (housekeeping,
Industrial hygienist, infection control, chaplain or medical secretary)
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Inspections Over ‐ Areas of Improvement Identified
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Implementing Action Plans
- Level of Action Depends on Finding(s)
- Reevaluate, Retrain and Requalify
- Investigate the source of contaminant
- HVAC systems, damaged HEPA filters
- Changing cleaning supplies
- Second opinion‐ another vendor
- Change in risk level/ category BUD changes
- Outsource SPC
- Renovation
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References
- Patton KA. Preparing the Hospital Pharmacy for a Joint Commission Survey. PPAmag.com 2008;10‐13.
- Pharmaceutical Compounding—Sterile Preparations. U.S. Pharmacopeia Convention official website.
www.usp.org/usp‐nf/notices/general‐chapter‐797‐proposed‐revision. Accessed May 30, 2017.
- The ASHP Discussion Guide on USP Chapter 797 for Compounding Sterile Preparations. www.ashp.org/‐
/media/assets/pharmacy‐practice/pharmacy‐topics/sterile‐compunding/ashp‐discussion‐guide‐on‐usp‐ chapter‐797.pdf. Accessed May 30, 2017.