1 / 26

Services and Supplies to Meet USP <797> Requirements

Services and Supplies to Meet USP <797> Requirements. Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Pharmacy Solutions patricia.kienle@cardinalhealth.com. Objectives. Identify required garb Review supply requirements

kyrie
Download Presentation

Services and Supplies to Meet USP <797> Requirements

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Services and Supplies to Meet USP <797> Requirements Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Pharmacy Solutions patricia.kienle@cardinalhealth.com

  2. Objectives • Identify required garb • Review supply requirements • Explain certification parameters

  3. Agenda - Supplies • Garb • IV Room supplies • Cleaning products • Hand scrubs • Cleaning sterile areas • Monitoring • Agar plates, strips, other media • Media-fill test kits

  4. Agenda - Services • Certification of hoods and rooms • Electronic air sampling

  5. Garb • Hair covers • Head and facial hair • Masks • Booties • Gowns • Regular and chemo • Gloves • Regular and chemo • Powder-free

  6. Placement of Garb • Neat • Appropriate sizes • Wire rack • Wall units • To minimize or cover paper or cardboard containers

  7. IV Room Supplies • Syringes • Needles • Transfer pins • Wipes • Dry and wet • Sterile alcohol

  8. Placement of Supplies • Minimize cardboard • Use plastic bins • Minimize amount of supplies in the clean areas • Sticky mats

  9. Chemo Prep Supplies • Eye protection • Chemo spill kits • Transport bags

  10. CSTD • Closed-system vial transfer device • System required if laminar air flow workbench and BSC in same room

  11. Sterile Containers used for CSPs Sterile container: Acceptable Non-sterile container: Unacceptable

  12. Trash • Regular trash • Sharps • Chemo trace • Non-hazardous pharmaceutical waste • RCRA

  13. Developing a List of Products • Basic list • Specialty products • Based on what your are compounding

  14. Hand Washing • Surgical scrub • Solution • Brush • Gels • Air dryer • Lint-free cloths

  15. Cleaning and Disinfecting • Cleaning • Removes loose materials and residue • Disinfecting • Sanitizes the surface

  16. Cleaning the Sterile Area • Pails • Mops • Disposable • Lint-free • Solutions • Need to be approved by hospital’s Infection Control Committee

  17. Routine Monitoring • Temperature records • Log for room temperature • Log or graphs for refrigerators and freezers

  18. Monitoring • Media-fill kits • Agar plates, strips, media • Neutralized so valid with disinfectants • Caseine soy broth • TSB • Petri dish

  19. Hood Certification • Primary Engineering Controls (“hoods”) • Secondary Engineering Controls • Buffer area • Ante area • Segregated Compounding Area • Particle counter • Electronic air sampling

  20. Hood Certification Contract • Old days • Particle count every six months in each hood • Now • Particle count, validation of pressure/velocity readings, electronic air sampling every six months • Each Primary Engineering Control (hood, isolator) • All buffer and ante areas

  21. Primary Engineering Control • Laminar air flow workbench • Biological safety cabinet • Compounding aseptic isolator • Compounding aseptic containment isolator

  22. Secondary Engineering Controls • Buffer area • Where the PECs are located • Ante area • Area outside the buffer area

  23. Environmental Monitoring • Particle count • Pressure or velocity reading confirmation • Electronic air sampling

  24. Certification Report • Review with certifier • Ask for executive summary • Pass / fail • What needs to be corrected • Follow up areas with concerns

  25. Resources • USP <797> • ASHP Guidelines • Compounding Sterile Preparations • Hazardous Drugs • Outsourcing • Ophthalmics • TPN • www.pppmag.com

  26. Q&A

More Related