Measure Standard Q1 Q2 Q3 Q4 Point of Use Gross Debris Removed during & after procedure (use of water preferred) 5 Delicate instruments on top of heavy or separate 5 Devices contained & identified as biohazard during transport 5 Transport of soiled items to decontamination area completed within identified time frame 5 Soiled items moist during transport to decontamination when transport delayed 5 Point of Use Total 25 0 0 0 0 Decontamination Physical flow supports moving from soiled to clean 5 Compressed air available 5 Flush tip device available & used for lumens 5 Sink deep enough for gross rinsing 5 Cleaner dilution rate correct 5 Ultrasonic cleaners routinely used on most instruments 5 Three sink configuration in place 5 Water temperature monitored 5 Separate hand wash area 5 Ophthalmic instruments cleaned separately following TASS recommendations 5 Immersible devices are cleaned under the surface of the water 5 Reusable cleaning tools, such as brushes, are decontaminated at least daily 5 Final rinse water is RO or DI treated 5 Flexible scopes, other than scopes such as cystoscopes, laryngoscopes, or similar cleaned in separate decontamination area 5 Leak testing for flexible scopes 5 Temperature 60º - 73º & documented 5 Humidity max 60% & documented 5 Air exchanges at least 10/hour 5 Negative air exchanges 5 J. Spear C. Spry 2015 Page 1 of 5
Decontamination Total 95 0 0 0 0 Prep and Pack Clean & neat workstations 5 Individual workstations (working space not shared) 5 Workstations stocked in standard configuration 5 Packaging, wrap on racks 5 Peel Pouches used for individual or few instruments 5 Containers checked to ensure good working order 5 Count sheet uses specific individual number for identifier 5 Set & item pictures available 5 Back up instruments in area 5 Supplies for Instrument function testing available 5 Instrument lubricant available 5 No instrument cleaning done in area 5 Set weights within recommendations 5 Instruments visually inspected for cleanliness during assembly 5 Instruments inspected for completeness during assembly 5 Temperature 68º - 73º & documented 5 Humidity max 60% & documented 5 Air exchanges at least 10/hour 5 Positive air exchanges 5 Prep & Pack Total 95 0 0 0 0 Sterilizer Routine exterior sterilizer cleaning per instructions 5 Routine drain check at least daily 5 Routine interior cleaning per instructions 5 Routine gasket check at least daily 5 Lot number assigned to each individual item 5 Extended cycle items clearly identified 5 All cycles documented & retrievable 5 Recall procedure in place 5 J. Spear C. Spry 2015 Page 2 of 5
Load configuration requires peel pouches to be on edge & on top, containers are not above wrapped items 5 Cooling time is defined or release temperature is defined 5 Sterilizer access room clean & uncluttered 5 Sterilizer access room maintains negative pressure 5 Sterilizer access room has at least 10 air exchanges per hour 5 Sterilizer access room temperature & humidity within sterilizer specifications 5 Documentation of all maintenance, accurate, & retrievable 5 Preventive maintenance performed routinely & documented 5 Loading area Temperature 68º - 73º & documented 5 Loading area Humidity max 60% & documented 5 Loading area Air exchanges at least 10/hour 5 Loading area positive air exchanges 5 Sterilizer Total 100 0 0 0 0 Storage No stacking of wrapped sets 5 Clean & neat workstations 5 Content labels on all items 5 Lot number on each individual item 5 Temp 75º or less & documented 5 Humidity 60% or less & documented 5 Air exchanges at least 4/hour 5 Bottom shelf solid & at least 8" from floor 5 Storage Total 40 0 0 0 0 Infection Prevention PPE available in adequate supply 5 PPE used routinely & correctly by personnel including donning & doffing 5 Hand hygiene principles followed in all areas 5 Infection Prevention Total 15 0 0 0 0 Quality Monitoring J. Spear C. Spry 2015 Page 3 of 5
Daily air removal testing 5 BI testing at least weekly & with every implant load (lot number of control & BI processed match) 5 Washer decontaminator tested for efficacy at least weekly 5 Ultrasonic cleaner tested for efficacy at least weekly 5 Instruments tested for cleanliness following decontamination on a routine basis 5 Lumens tested for cleanliness on a routine basis 5 Sterilized set/item auditing for cleanliness, device function, complete according to count sheet 5 Quality Monitoring Total 35 0 0 0 0 Policies Infection Control - Sterilization 5 Sterilizer load or set recall 5 Attire for each area 5 Environmental cleaning responsibilities 5 Loaned instrument handling 5 Protocol for IFU review & accessibility in place 5 Policy Total 30 0 0 0 0 Environment Clean & orderly in all areas 5 Floors, walls, ceilings intact & easily cleaned in all areas 5 Dry floors or wet floor sign in place 5 Physical separation of decontamination and other areas 5 No outer shipping cartons in working areas 5 Environment Total 25 0 0 0 0 Safety Equipment Eye wash present & tested & documented 5 Shower present & tested & documented 5 Food or drink not present in working areas 5 Safety Equipment Total 15 0 0 0 0 J. Spear C. Spry 2015 Page 4 of 5
Total Department Score 475 0 0 0 0 J. Spear C. Spry 2015 Page 5 of 5