Services and Supplies to Meet USP <797> Requirements

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