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  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.

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 1 st version of USP Chapter 797

Enforcing Compliance  FDA  State Board of Pharmacy  The Joint Commission  Office of Internal General  You and I

Garb Up! Don’t Get Caught Off Guard

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

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)

Inspections Over ‐ Areas of Improvement Identified

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

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.