PRESENTED BY JUNE 17, 2016 LOS ANGELES, CALIFORNIA UCLA
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1 PRESENTED BY JUNE 17, 2016 LOS ANGELES, CALIFORNIA UCLA
2 Opera&onal Impacts of Adhering to NIOSH and USP 800 Standards Shelley R. Carry, CIH, CSP Kaiser Permanente NEH&S Principal Consultant Acknowledgement Corbin BenneJ, PharmD, MPH Senior Director of Oncology Services
3
4 Stats from hjp://share.kaiserpermanente.org/ar&cle/fast- facts- about- kaiser- permanente/. Current as of March 31, 2016
5 Oncology and OutpaEent Infusion Pharmacies
6 Agenda What have we done well? What are our biggest challenges? What are we working on?
7 What have we done well? Facili&es clean room design Closed system drug- transfer device (CSTD) implementa&on Standardized training and competency
8 Facili&es Templates updated to meet USP 800 standards Addi&on of dedicated receiving area with neutral/normal/nega&ve pressure Inser&on of refrigerator into nega&ve buffer area
9 Nega&ve Pressure Room Refrigerator Receiving Area (Neutral/ Nega&ve)
10 CSTDs USP 800: CSTDs should be used when compounding {hazardous drugs} HDs when the dosage form allows. CSTDs must be used when administering an&neoplas&c HDs when the dosage form allows Program wide implementa&on : September, 2014 June, 2015 Ambulatory Infusion Inpa&ent Pharmacy & Nursing same system
11 Training & Competency Collabora&on with American Society of Health - System Pharmacists (ASHP) Sterile compounding training Na&onal Pharmacy Orienta&on Checklist Na&onal Pharmacy Competency
12 Na&onal Pharmacy Onboarding
13 Na&onal Pharmacy Competency
14 What are our biggest challenges? Hazardous Drug (HD) list Risk assessment Communica&on strategy Cleaning & Decontamina&on requirements Environmental monitoring
15 HD List the never ending story KP Version 1 June, 2015 KP Version 2 December, 2015 KP Version 3 February 1, 2016 (USP 800) Now wai&ng for NIOSH 2016
16 Cleaning and Decontamina&on Sporicidal Agents USP must be used at least weekly to clean all ISO- classified and segregated compounding areas California Board of Pharmacy must be used monthly (effec&ve Jan. 1, 2017)
17 Sporicidal Occupa&onal exposure limits: Bleach 8- hr Cal/OSHA 8- hr Time Weighted Average (TWA) Permissible Exposure Limit (PEL) of 0.5 part per million (ppm) Short Term Exposure Limit (STEL) of 1 ppm Hydrogen peroxide Cal/OSHA 8- hr TWA PEL of 1 ppm Peroxyace&c acid (perace&c acid) ACGIH STEL Threshold Limit Value (TLV) of 0.4 ppm
18 Sporicidals Work Ac&vi&es EVS staff using sporicidal agent to disinfect floors, walls, ceilings and shelving of the ante, buffer and laminar flow rooms in pharmacies Pharmacy staff using bleach to decontaminate the inside of the BSC located in the hazardous drug compounding room Pharmacy staff using bleach or sporicidal agent to disinfect surfaces of the laminar flow hood located in the non- hazardous compounding room
19 Environmental Monitoring USP 797 viable surface sampling required monthly USP 800 environmental wipe sampling for HD residue should be performed rou&nely.
20 What are we working on? Remodeling facili&es Camera Technology Na&onal Waste Policy Na&onal HD List Standardizing policies: Addi&onal PPE (Personal Protec&ve Equipment) requirements
21 Region # of Sterile Compounding (SC) Pharmacies # of SC Pharmacies Requiring Major or Complete Remodel CO 5 0 GA 3 0 HI 4 3 MAS 6 0 NCAL NW 7 0 SCAL Total (46%) Pharmacy Remodeling
22 Remodeling - Strategy Consolidate sterile compounding when possible based on: Volume Distance to nearest compliant pharmacy Future plans for addi&onal services Future growth Consolidate hazardous drug / an&neoplas&c compounding when possible based on factors above. Remodel only if consolida&on not feasible
23 Camera ( Medsafe ) Compounding camera Remote checking of prepara&ons in nega&ve pressure room Eliminates need for pharmacist to gown up ( payroll, non- payroll)
24 Na&onal Waste Policy To mingle or not to mingle that is the ques&on vs.
25 Standardized Policies USP not just a pharmacy issue Ensure consistency in nursing prac&ce, environmental services, and supply chain Addi&onal PPE requirements A second pair of shoe covers must be donned before entering the C- SEC and doffed when exi&ng Disposable sleeve covers may be used Eye protec&on Respiratory protec&on
26 Ques&ons?
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