Regulatory Basics
This organization accredits and certifies healthcare organizations.
What is the Joint Commission?
Response if surveyors ask a question that you don’t know the answer to
What is “I don’t know but here is how I would find the answer”?
This is why medications must be stored in a locked room, drawer, or cabinet.
To prevent misuse, tampering, and theft
Placement of hands while making sterile compounds must not ever block these areas.
Critical points
Critical sites - Any part of the needle; septum of the vial; the sides of the plunger of syringe
What is EVS responsible for cleaning on a daily basis?
Sink, floors, trash cans, passthroughs, doors/door handles
R.A.C.E stands for this.
Rescue, Alarm, Confine, Evacuate
This collection of documents provides the written step-by-step instructions that outline how to perform tasks
What is the Standard Operating Procedures.
Sharepoint -> Policies and SOPs (top of page)
The place to find high alert, look alike sound alike list, and hazardous drug list
HUP formulary on Lexicomp
Items being placed in the compounding hood should be wiped down with
Alcohol wipe – 70% isopropyl alcohol
Items should be wiped down with sterile alcohol as they enter the compounding hood unless packaged in a sterile container and introduced directly from the package into the PEC
What areas of the cleanroom gets cleaned by EVS (and pharmacy) on a monthly basis?
The entire cleanroom suite, all the carts, bins, ceiling, walls, door, door handles, door frame, passthroughs, sinks, trash cans
P.A.S.S is an acronym used to guide someone to use a fire extinguisher. It stands for:
Pull pin, Aim at base of fire, Squeeze, Sweep side to side
Where would you find the information about dwell times for cleaning agents in sterile compounding?
The SOPs
Cleaning and Disinfection of Non-Hazardous Primary Engineering Controls (PECs)
SOP Number: HUP.IP.SP.008
Problem with the following medication order: Oxycodone 5 mg three times a day for pain, Acetaminophen 650 mg PRN for pain
Therapeutic duplication: need to specify when each medication should be used, specifically including a pain score.
What items should be absent/restricted on staff or in the clean room?
No make-up, jewelry, or outer garments (sweaters, hoodies, et); eyelash extenders; nail products
What SOPs can be referenced for clean room cleaning?
- Cleaning and Disinfection of Non-Hazardous PECs
- Monthly Sporicidal Disinfection of Non-Hazardous PECs
- EVS Daily Cleaning and Disinfection of Non-Hazardous and Hazardous SECs
- EVS Monthly Cleaning and Disinfection of Non-Hazardous and Hazardous Secondary Engineering Controls
When using the eyewash, flush your eyes for __ minutes:
What is 15 minutes?
What tool is used for BUDs?
Manufacturer's instructions for use (package insert)
The BatchMaster label
CNR (Epic)
This document should be used to protect from hazardous chemicals exposures in cases like spills, handling, and measures to control exposures
MSDS (Material Safety Data Sheet)
UPHS Intranet -> MSDS/SDS Access (side of page)
Name 3 items should staff wear to be appropriately garbed for the compounding area?
Shoe covers (non-HD = single), (HD = double)
Gown (non-HD = non-chemo), (HD = chemo gown)
Gloves (non-HD = sterile gloves), (HD = double, chemo nitrile)
Mask
Bonnet/cap
What are the tasks that need to be documented for the cleanroom and sterile compounding spaces?
Daily hood and room cleaning
Monthly hood and room cleaning
Deactivation and Decontamination daily for HDs
Deactivation and decontamination monthly for under the tray
There must be __ inches or more of open space below the sprinkler to the top of storage:
What is 18 inches?
What is the SOP that tells you the proper temperature, pressure, and humidity?
How often do you need to document this?
Name the SOP if physical plant needs to be called.
SOP Number: HUP. IP. SP. 019
- Minimum pressure differential must not be less than 0.020 inch
- Temperature of clean room must be 20°C or cooler
- The relative humidity of the clean room must be 60% or below
Documentation - temperature, pressure, and humidity (DAILY)
If physical plant needs to be called - SOP Required Action (Step 6)
Points in care is medication reconciliation required (Pharmacist-level question)
The three critical transition points are:
Admission (within 24 hours)
Transfer (interdepartmental or inter-facility)
Discharge (prior to patient leaving the facility)
Unidirectional air that exits the HEPA filter that is essentially sterile and particle free which should not be blocked at critical points like the area where the needle has entered the vial.
First Air
What does the monthly cleaning and disinfection entail? What are the agents used? Who is responsible to document?
All surface inside non-HD and HD SECs must undergo cleaning and disinfection with approved EPA Registered ONE STEP Sporicidal Cleaner Disinfectant agent by designated personnel
Designated EVS personnel are responsible for completing monthly cleaning
All HUP compounding personnel are responsible for cleaning disinfection documentation prior to the start of next shift.
See SOPs for more specific details on procedure.