services and supplies to meet usp requirements patricia c. kienle, rph, mpa, fashp director,...
TRANSCRIPT
Services and Supplies to Meet USP <797> Requirements
Patricia C. Kienle, RPh, MPA, FASHPDirector, Accreditation and Medication SafetyCardinal Health Pharmacy [email protected]
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Objectives
Identify required garbReview supply requirementsExplain certification parameters
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Agenda - Supplies
GarbIV Room suppliesCleaning products
Hand scrubsCleaning sterile areas
MonitoringAgar plates, strips, other mediaMedia-fill test kits
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Agenda - Services
Certification of hoods and roomsElectronic air sampling
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Garb
Hair covers Head and facial hair
Masks Booties Gowns
Regular and chemo Gloves
Regular and chemo Powder-free
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Placement of Garb
NeatAppropriate sizesWire rackWall units
To minimize or cover paper or cardboard containers
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IV Room Supplies
SyringesNeedlesTransfer pinsWipes
Dry and wetSterile alcohol
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Placement of Supplies
Minimize cardboard
Use plastic binsMinimize amount
of supplies in the clean areas
Sticky mats
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Chemo Prep Supplies
Eye protectionChemo spill kitsTransport bags
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CSTD
Closed-system vial transfer device
System required if laminar air flow workbench and BSC in same room
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Sterile Containers used for CSPs
Sterile container:Acceptable
Non-sterilecontainer:Unacceptable
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Trash
Regular trashSharpsChemo trace Non-hazardous pharmaceutical waste RCRA
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Developing a List of Products
Basic listSpecialty products
Based on what your are compounding
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Hand Washing
Surgical scrubSolutionBrush
GelsAir dryerLint-free cloths
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Cleaning and Disinfecting
CleaningRemoves loose materials and residue
DisinfectingSanitizes the surface
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Cleaning the Sterile Area
PailsMops
Disposable Lint-free
SolutionsNeed to be approved by hospital’s Infection
Control Committee
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Routine Monitoring
Temperature recordsLog for room
temperatureLog or graphs for
refrigerators and freezers
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Monitoring
Media-fill kitsAgar plates, strips, media
Neutralized so valid with disinfectantsCaseine soy brothTSBPetri dish
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Hood Certification
Primary Engineering Controls (“hoods”)Secondary Engineering Controls
Buffer areaAnte area
Segregated Compounding AreaParticle counter
Electronic air sampling
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Hood Certification Contract
Old daysParticle count every six months in each hood
NowParticle count, validation of pressure/velocity
readings, electronic air sampling every six months
Each Primary Engineering Control (hood, isolator)
All buffer and ante areas
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Primary Engineering Control
Laminar air flow workbenchBiological safety cabinetCompounding aseptic isolatorCompounding aseptic containment
isolator
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Secondary Engineering Controls
Buffer areaWhere the PECs are located
Ante areaArea outside the buffer area
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Environmental Monitoring
Particle count Pressure or velocity reading
confirmation Electronic air sampling
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Certification Report
Review with certifierAsk for executive summary
Pass / failWhat needs to be corrected
Follow up areas with concerns
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Resources
USP <797>ASHP Guidelines
Compounding Sterile PreparationsHazardous DrugsOutsourcingOphthalmicsTPN
www.pppmag.com
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Q&A