AHS - IC - Sterile Processing Audit Worksheet 2020

• Conducted on

  Date

• Prepared by

• Location

  Select

• Select

• Select

• Select

• Specify clinic:

• The three major resources for standards and recommended practices for SPD are The Association for the Advancement of Medical Instrumentation (AAMI), The Association of periOperative Registered Nurses (AORN) and the Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008 by William Rutala, Ph.D, M.P.H., David Weber, M.D., M.P.H and the Healthcare Infection Control Practices Advisory Committee (HICPAC).

• AAMI's Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2006 and ANSI/AAMI/A1:2008/A2:2009) is a complete guideline for all steam sterilization activities. AAMI has combined five recommended practices into this one standard. No matter what the size of the facility or the size of the sterilizer, this is a "must-have" resource that every SPD, Operating Room (OR) and IP should have readily available.
  
  The five recommended practices incorporated into ST79 are:
  •ANSI/AAMI ST46, Steam sterilization and sterility assurance in health care facilities
  •ANSI/AAMI ST42, Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities
  •ANSI/AAMI ST37, Flash sterilization: Steam sterilization of patient care items for immediate use
  •ANSI/AAMI ST35, Safe handling and biological decontamination of medical devices in health care facilities and in non-clinical settings
  •ANSI/AAMI ST33, Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities.
  

• Gross contaminant is removed with water

  Yes

  No

  N/A

  Not Observed

• Instruments are sorted: Sharps removed

  Yes

  No

  N/A

  Not Observed

• Instruments are sorted: Instruments placed back in original container.

  Yes

  No

  N/A

  Not Observed

• Instruments are sorted: un-used instruments placed in bottom of basket.

  Yes

  No

  N/A

  Not Observed

• Instruments are sorted: Towel placed on top of unused instruments

  Yes

  No

  N/A

  Not Observed

• Instruments are sorted: Used instruments placed on top of towel.

  Yes

  No

  N/A

  Not Observed

• Enzymatic pre-cleaner applied to used instruments.

  Yes

  No

  N/A

  Not Observed

• Water moistened towel placed over instruments.

  Yes

  No

  N/A

  Not Observed

• No other non-compliances observed.

  Yes

  No

  N/A

  Not Observed

• Soiled items are contained.

  Yes

  No

  N/A

  Not Observed

• Soiled items are transported covered.

  Yes

  No

  N/A

  Not Observed

• Transportation devices is labeled e.g. Soiled/Biohazard.

  Yes

  No

  N/A

  Not Observed

• No other non-compliances observed.

  Yes

  No

  N/A

  Not Observed

Environment

• Temperature is 16 - 18 deg C (60-73F) (ANSI/AAMI 3.3.6.5)

  Yes

  No

  N/A

  Not Observed

• Humidity - Not to exceed 60%. (ANSI/AAMI 3.3.6.6)

  Yes

  No

  N/A

  Not Observed

• Air Exchanges - 10 per hour. (ANSI/AAMI 3.3.6.4)

  Yes

  No

  N/A

  Not Observed

• Negative air pressure. (ANSI/AAMI 3.3.6.4)

  Yes

  No

  N/A

  Not Observed

• Area is clean. (ANSI/AAMI 3.4)

  Yes

  No

  N/A

  Not Observed

• Surfaces/cabinets are nonporous. (ANSI/AAMI 3.3.7.1)

  Yes

  No

  N/A

  Not Observed

• Lighting is sufficient. (ANSI/AAMI 3.3.6.7)

  Yes

  No

  N/A

  Not Observed

• Temperature & humidity is checked and documented daily. (ANSI/AAMI 3.3.6.5-3.3.6.6)

  Yes

  No

  N/A

  Not Observed

• Staff know how procedure for documenting and reporting out of range readings.

  Yes

  No

  N/A

  Not Observed

• Soiled and clean areas are separated physically or procedurally. (ANSI/AAMI 3.3.7.1)

  Yes

  No

  N/A

  Not Observed

• Handwashing sink is separate from decontamination sink. (ANSI/AAMI 3.3.6.8)

  Yes

  No

  N/A

  Not Observed

• Handwashing sink has hands free operation. (ANSI/AAMI 3.3.6.8)

  Yes

  No

  N/A

  Not Observed

• Handwashing sink is located next to exit door. (ANSI/AAMI 3.3.6.8)

  Yes

  No

  N/A

  Not Observed

• Area is secure from general traffic and labeled appropriately. (ANSI/AAMI 3.4)

  Yes

  No

  N/A

  Not Observed

Chemistries

• Water level is sufficient to submerge 1 tray. (ANSI/AAMI 7.5.6)

  Yes

  No

  N/A

  Not Observed

• Solutions are diluted appropriately. (ANSI/AAMI 7.3)

  Yes

  No

  N/A

  Not Observed

• Sinks are marked.

  Yes

  No

  N/A

  Not Observed

• Appropriate solutions are utilized - Manual - Enzymatic for pre-cleaning. (ANSI/AAMI 7.5.3.2)

  Yes

  No

  N/A

  Not Observed

• Appropriate solutions are utilized - Manual - Detergent for wash. (ANSI/AAMI 7.5.3.2)

  Yes

  No

  N/A

  Not Observed

• Appropriate solutions are utilized - Manual - Low foaming/sudsing. (ANSI/AAMI 7.5.3.2)

  Yes

  No

  N/A

  Not Observed

• Appropriate solutions are utilized - Manual - Treated water for final rinse. (ANSI/AAMI 7.5.3.2)

  Yes

  No

  N/A

  Not Observed

• No other non-compliances observed.

  Yes

  No

  N/A

  Not Observed

Process Flow

• Items are pre-cleaned. (ANSI/AAMI 7.3)

  Yes

  No

  N/A

  Not Observed

• Appropriate items are submerged and cleaned under water to prevent aerosolization. (ANSI/AAMI 7.6.3.2)

  Yes

  No

  N/A

  Not Observed

• Appropriate brushes are available and in good condition. (ANSI/AAMI 7.5.6)

  Yes

  No

  N/A

  Not Observed

• Reusable brushes are cleaned on a routine basis - staff can articulate how & when. (ANSI/AAMI 7.5.6)

  Yes

  No

  N/A

  Not Observed

• Disposable brushes are not reused. (N.2.2.7)

  Yes

  No

  N/A

  Not Observed

• Lumens are brushed and irrigated. (ANSI/AAMI 7.5.3.2)

  Yes

  No

  N/A

  Not Observed

• Lumened instruments are cleaned according to MIFUs (may include borescope and/or ultrasonic methods).

  Yes

  No

  N/A

  Not Observed

• Instruments are disassembled per manufacturer's recommendations. (ANSI/AAMI 7.2.2)

  Yes

  No

  N/A

  Not Observed

• Containers are cleaned per manufacturer's recommendations. (ANSI/AAMI 7.5.9)

  Yes

  No

  N/A

  Not Observed

• Manufacturer's cleaning instructions are available for all items. (ANSI/AAMI 7.5.6)

  Yes

  No

  N/A

  Not Observed

• TOSI (Test Object Surgical Instrument) is a test used to demonstrate the effectiveness of the washing/ultrasonic cleaning process in addition to quality controls performed on temperatures and/or detergents. It uses a synthetic soil developed to mimic the properties of blood and other proteinaceous contaminants but is sterile and will not contaminate instruments being processed.

• Verification of ultrasonic cleaning process is performed (TOSI). (ANSI/AAMI 7.5.5)

  Yes

  No

  N/A

  Not Observed

• Verification of washer cleaning process is performed (TOSI)(ANSI/AAMI 7.5.5)

  Yes

  No

  N/A

  Not Observed

• Verifications of cleaning processes are logged/documented.

  Yes

  No

  N/A

  Not Observed

Safety

• Approved eyewash station is available and in working condition. (ANSI/AAMI 3.3.8)

  Yes

  No

  N/A

  Not Observed

• If eyewash station is attached to a sink hot water is disabled

  Yes

  No

  N/A

  Not Observed

• Eyewash station is tested weekly and documented

  Yes

  No

  N/A

  Not Observed

• Eyewash station is located in decontamination or within 10 seconds of chemicals

  Yes

  No

  N/A

  Not Observed

• Staff know what MSDS is and where to find them. (ANSI/AAMI 4.2.2)

  Yes

  No

  N/A

  Not Observed

• All chemicals have an MSDS on file

  Yes

  No

  N/A

  Not Observed

• Staff know facility procedures for: Handwashing (ANSI/AAMI 4.2.2)

  Yes

  No

  N/A

  Not Observed

• Staff know facility procedures for: Bloodborne Pathogens Exposure (ANSI/AAMI 4.2.2)

  Yes

  No

  N/A

  Not Observed

• Staff are wearing appropriate PPE: Waterproof gown with sleeves.

  Yes

  No

  N/A

  Not Observed

• Staff are wearing appropriate PPE: Decontamination gloves (not procedural) (ANSI/AAMI 4.5.2)

  Yes

  No

  N/A

  Not Observed

• Staff are wearing appropriate PPE: Disposable cap (ANSI/AAMI 4.5.2)

  Yes

  No

  N/A

  Not Observed

• Staff are wearing appropriate PPE: Faceshield/goggles (ANSI/AAMI 4.5.2)

  Yes

  No

  N/A

  Not Observed

• Staff are wearing appropriate PPE: Mask (ANSI/AAMI 4.5.2)

  Yes

  No

  N/A

  Not Observed

• Staff are wearing appropriate PPE: Shoe covers (ANSI/AAMI 4.5.2)

  Yes

  No

  N/A

  Not Observed

• No other non-compliances observed.

  Yes

  No

  N/A

  Not Observed

Environment

• Temperature - 20 - 23 deg C ( 68 - 73 deg F) (ANSI/AAMI 3.3.6.5)

  Yes

  No

  N/A

  Not Observed

• Humidity - 30% - 60% (ANSI/AAMI 3.3.6.6)

  Yes

  No

  N/A

  Not Observed

• Air Exchanges - 4 per hour (ANSI/AAMI 3.3.6.4)

  Yes

  No

  N/A

  Not Observed

• Positive Air Pressure (ANSI/AAMI 3.3.6.4)

  Yes

  No

  N/A

  Not Observed

• Area is clean (ANSI/AAMI 3.4)

  Yes

  No

  N/A

  Not Observed

• Surfaces are non-porous and easy to clean (ANSI/AAMI 3.3.7.2)

  Yes

  No

  N/A

  Not Observed

• Lighting is sufficient (ANSI/AAMI 3.3.6.7)

  Yes

  No

  N/A

  Not Observed

• Temp & Humidity is checked and documented daily -3.3.6.6(ANSI/AAMI 3.3.6.5-3.3.6.6)

  Yes

  No

  N/A

  Not Observed

• Staff know procedure for documenting and reporting out of range readings.

  Yes

  No

  N/A

  Not Observed

• Yes

  No

  N/A

  Not Observed

Work Area

• Is clean and organized. (ANSI/AAMI 3.4)

  Yes

  No

  N/A

  Not Observed

• Contains appropriate supplies to reduce time away from assembly area: (ANSI/AAMI 3.3.7.2)

  Select Indicators/integrators Tray liners Tip protectors Packaging Supplies (e.g. locks/arrows, data cards, filters) Sharpness Testing Material Insufficient materials at hand

  • Indicators/integrators
  • Tray liners
  • Tip protectors
  • Packaging Supplies (e.g. locks/arrows, data cards, filters)
  • Sharpness Testing Material
  • Insufficient materials at hand

• Lighted magnification is available.

  Yes

  No

  N/A

  Not Observed

Set Assembly

• There is a computer tracking system in place and is used appropriately

  Yes

  No

  N/A

  Not Observed

• Set sheets are accurate, organized and easy to read

  Yes

  No

  N/A

  Not Observed

• Containers/Baskets are labeled to match set sheets

  Yes

  No

  N/A

  Not Observed

• All instruments are inspected for: Sharpness (ANSI/AAMI 8.4.3)

  Yes

  No

  N/A

  Not Observed

• All instruments are inspected for: Functionality (ANSI/AAMI 8.4.3)

  Yes

  No

  N/A

  Not Observed

• All instruments are inspected for: Insulation integrity (ANSI/AAMI 8.4.3)

  Yes

  No

  N/A

  Not Observed

• All instruments are inspected for: Cleanliness (especially lumens, bone instruments)(ANSI/AAMI 8.4.3)

  Yes

  No

  N/A

  Not Observed

• All instruments are inspected for: Dryness (ANSI/AAMI 8.4.3)

  Yes

  No

  N/A

  Not Observed

• Instruments are disassembled/assembled per manufacturer's recommendations (MIFUs) (ANSI/AAMI 8.4.1)

  Yes

  No

  N/A

  Not Observed

• Lumens are flushed with sterile or distilled water (ANSI/AAMI 8.3.8)

  Yes

  No

  N/A

  Not Observed

• Peel pouches are not placed in instrument sets (ANSI/AAMI 8.3.4)

  Yes

  No

  N/A

  Not Observed

• Indicator/Integrator is placed in challenging location and all levels of multi-level trays (ANSI/AAMI 10.5.2.2.2)

  Yes

  No

  N/A

  Not Observed

Packaging

• Containers/baskets are inspected for: (ANSI/AAMI 8.4.3)

  Select Functionality Cleanliness Sharp Edges Not inspected

  • Functionality
  • Cleanliness
  • Sharp Edges
  • Not inspected

• Sets are wrapped appropriately. (ANSI/AAMI 8.3.1)

  Yes

  No

  N/A

  Not Observed

• Filters and locks are placed appropriately. (ANSI/AAMI 8.3.3)

  Yes

  No

  N/A

  Not Observed

• Sets are labeled appropriately - wrapped items are labeled on tape. (ANSI/AAMI 8.3.2)

  Yes

  No

  N/A

  Not Observed

Peel Pouches (ANSI/AAMI 8.3.4)

• Are appropriate size.

  Yes

  No

  N/A

  Not Observed

• Are sealed appropriately

  Yes

  No

  N/A

  Not Observed

• Double peel pouches are appropriate size not folded

  Yes

  No

  N/A

  Not Observed

• Peel pouches are placed plastic to plastic and paper to paper

  Yes

  No

  N/A

  Not Observed

• Peel pouches are correct modality.

  Yes

  No

  N/A

  Not Observed

• Are labeled appropriately with accurate descriptions

  Yes

  No

  N/A

  Not Observed

• Are labeled on the plastic side not the paper side.

  Yes

  No

  N/A

  Not Observed

Manufacturers' Instructions for Use (MIFU)

• Wrap/Container/Peel Pouch IFUs available (ANSI/AAMI 8.2)

  Yes

  No

  N/A

  Not Observed

• Peel Pouch validation for double peel pouching available (ANSI/AAMI 8.3.4)

  Yes

  No

  N/A

  Not Observed

Safety

• Sets adhere to AAMI recommended weight limit of 25lbs. (ANSI/AAMI 8.4.2)

  Yes

  No

  N/A

  Not Observed

• Work Stations are at appropriate heights (ANSI/AAMI 3.3.7.1)

  Yes

  No

  N/A

  Not Observed

• Staff assembling manual cleaned instruments are wearing gloves

  Yes

  No

  N/A

  Not Observed

• Staff inspect sets for sharps prior to reaching into the baskets (ANSI/AAMI 7.4.1)

  Yes

  No

  N/A

  Not Observed

• Proper body mechanics are used when lifting sets and pushing carts (ANSI/AAMI 6.5.4)

  Yes

  No

  N/A

  Not Observed

• No other non-compliances observed.

  Yes

  No

  N/A

  Not Observed

Equipment Maintenance (ANSI/AAMI 9.4)

• Sterilizers are clean and in working order

  Yes

  No

  N/A

  Not Observed

• Sterilizers are cleaned on a routine basis per manufacturer's recommendations (MIFU)

  Yes

  No

  N/A

  Not Observed

• Preventative maintenance is performed per manufacturer's recommendations

  Yes

  No

  N/A

  Not Observed

• Preventative maintenance is documented and available for review

  Yes

  No

  N/A

  Not Observed

• Daily maintenance is performed per manufacturer's recommendations (MIFU):

  Select Steam traps are removed and checked/cleaned daily STERRAD plate is removed and replaced/cleaned daily STERIS System 1 is wiped down daily with alcohol No daily maintenance per MIFU.

  • Steam traps are removed and checked/cleaned daily
  • STERRAD plate is removed and replaced/cleaned daily
  • STERIS System 1 is wiped down daily with alcohol
  • No daily maintenance per MIFU.

• Printers are in working order for accurate cycle verification.

  Yes

  No

  N/A

  Not Observed

Loading Sterilizer (ANSI/AAMI 8.5.1)

• Items w/similar sterilization parameters are placed in the same load

  Yes

  No

  N/A

  Not Observed

• Sets are positioned to facilitate air removal, steam penetration and drying

  Yes

  No

  N/A

  Not Observed

• Containers are placed beneath wrapped items and peel pouches (ANSI/AAMI 8.5.6)

  Yes

  No

  N/A

  Not Observed

• Peel Pouches are placed plastic to plastic and paper to paper (ANSI/AAMI 8.5.2)

  Yes

  No

  N/A

  Not Observed

• Peel Pouches are positioned on their side not flat

  Yes

  No

  N/A

  Not Observed

• If liners are used they are approved for use - manufacturer's IFUs on file (ANSI/AAMI 8.5.1)

  Yes

  No

  N/A

  Not Observed

• Difficult to dry sets are not placed over the drain

  Yes

  No

  N/A

  Not Observed

• Sets are placed flat not on their sides (ANSI/AAMI 8.5.3)

  Yes

  No

  N/A

  Not Observed

• Packages are checked for: (ANSI/AAMI 8.3.1)

  Select Wrap integrity Appropriate tape application Containers have filters/arrows Non-compliant observation - specify

  • Wrap integrity
  • Appropriate tape application
  • Containers have filters/arrows
  • Non-compliant observation - specify

• Load stickers/labels "Lot Control Identifier" are applied containing: (ANSI/AAMI 10.3.1)

  Select Sterilizer Number or Code Date Cycle Number Expiration Date - If Event Related - "Contents sterile unles package is opened or damaged. Please check before using" Non-compliance observed - specify

  • Sterilizer Number or Code
  • Date
  • Cycle Number
  • Expiration Date - If Event Related - "Contents sterile unles package is opened or damaged. Please check before using"
  • Non-compliance observed - specify

Sterilizer Records (ANSI/AAMI 10.3.2)

• Each load documentation includes:

  Select Load or lot number Specific contents including quantity, department, and specific description. Minimum exposure time and temperature or print out is attached Name/initials of Operator Results of BI or Bowie Dick if applicable Response of CI or PCD if applicable Non-compliance observed - specify

  • Load or lot number
  • Specific contents including quantity, department, and specific description.
  • Minimum exposure time and temperature or print out is attached
  • Name/initials of Operator
  • Results of BI or Bowie Dick if applicable
  • Response of CI or PCD if applicable
  • Non-compliance observed - specify

Cycle Selection (ANSI/AAMI 8.6.1)

• Appropriate cycles are posted near sterilization equipment

  Yes

  No

  N/A

  Not Observed

• All items have manufacturer's recommendations on file

  Yes

  No

  N/A

  Not Observed

Cycle Verification

• Physical Parameters are verified at end of cycle and tape is initialed/signed (ANSI/AAMI 10.3.2)

  Yes

  No

  N/A

  Not Observed

• CI, BI, PCD are opened, read, and documented prior to release of load (ANSI/AAMI 10.6.1)

  Yes

  No

  N/A

  Not Observed

Load Removal (ANSI/AAMI 8.8)

• Load is placed in a low traffic area

  Yes

  No

  N/A

  Not Observed

• Load is placed in an area away from vents, doors, windows, drafts

  Yes

  No

  N/A

  Not Observed

• Load is not touched until items are cool

  Yes

  No

  N/A

  Not Observed

• Loads are not released prior to cooling - if removed they are opened for flash

  Yes

  No

  N/A

  Not Observed

• Documentation procedure is in place for early release of implants

  Yes

  No

  N/A

  Not Observed

Immediate Use Sterilization

• Devices sterilized for immediate use should have the same level of cleaning and preparation as instruments being terminally sterilized. The most current AORN recommendations state: "Immediate-use sterilization" should be performed only if all of the following conditions are met:

• The device manufacturer's written instructions on cycle type, exposure times, temperature setting, and drying times (if recommended) are available and followed.

  Yes

  No

  N/A

  Not Observed

• Items are disassembled and thoroughly cleaned with detergent and water to remove soil, blood, body fats, and other substances.

  Yes

  No

  N/A

  Not Observed

• Lumens are brushed and flushed under water with a cleaning solution and rinsed thoroughly.

  Yes

  No

  N/A

  Not Observed

• Items are placed in a closed sterilization container or tray, validated for flash sterilization, in a manner that allows steam to contact all instrument surfaces.

  Yes

  No

  N/A

  Not Observed

• Measures are taken to prevent contamination during transfer to the sterile field.

  Yes

  No

  N/A

  Not Observed

• No other non-compliance observed.

  Yes

  No

  N/A

  Not Observed

Environment

• Temperature - 24 - 29 deg C ( 75 - 85 deg F) (ANSI/AAMI 8.9.2)

  Yes

  No

  N/A

  Not Observed

• Humidity - Not to exceed 70%

  Yes

  No

  N/A

  Not Observed

• Air Exchanges - min 4 per hour

  Yes

  No

  N/A

  Not Observed

• Positive Air Pressure

  Yes

  No

  N/A

  Not Observed

• Area is clean (ANSI/AAMI 3.4)

  Yes

  No

  N/A

  Not Observed

• Surfaces are non-porous (ANSI/AAMI 3.3.7.2)

  Yes

  No

  N/A

  Not Observed

• Temp & Humidity is checked and documented daily (ANSI/AAMI 3.3.6.5-3.3.6.6)

  Yes

  No

  N/A

  Not Observed

• Staff know procedure for documenting and reporting out of range reading

  Yes

  No

  N/A

  Not Observed

Shelving / Bins

• 8" - 10" from floor (ANSI/AAMI 8.9.2)

  Yes

  No

  N/A

  Not Observed

• 18" below ceiling or sprinkler heads

  Yes

  No

  N/A

  Not Observed

• 2" from outside walls

  Yes

  No

  N/A

  Not Observed

• If open shelving bottom shelf has barrier or solid shelf

  Yes

  No

  N/A

  Not Observed

• Shelves and bins are free of dust

  Yes

  No

  N/A

  Not Observed

• Shelves / bins are labeled with locations, set and peel pouch names

  Yes

  No

  N/A

  Not Observed

• Shelves are organized to facilitate quick location of sets

  Yes

  No

  N/A

  Not Observed

• There is an index for set location

  Yes

  No

  N/A

  Not Observed

Sets

• Sets are placed to protect the integrity of packaging (ANSI/AAMI 8.9.2)

  Yes

  No

  N/A

  Not Observed

• Stacked sets do not compromise sterility (ANSI/AAMI 8.9.2)

  Yes

  No

  N/A

  Not Observed

• Items are rotated 1st in 1st out (ANSI/AAMI 8.9.3)

  Yes

  No

  N/A

  Not Observed

• Items are rotated based on packaging IFUs validated Shelf Life (ANSI/AAMI 8.9.3)

  Yes

  No

  N/A

  Not Observed

• If dust covered:

  Select Dust cover is appropriate size Dust cover is approved for use - manufacturer's recommendations on file Dust cover is applied appropriately- immediately after cool down Non-compliance observed - specify

  • Dust cover is appropriate size
  • Dust cover is approved for use - manufacturer's recommendations on file
  • Dust cover is applied appropriately- immediately after cool down
  • Non-compliance observed - specify

Sterile Delivery (ANSI/AAMI 8.10.1)

• Items are cool prior to delivery

  Yes

  No

  N/A

  Not Observed

• Package integrity is maintained during transport

  Yes

  No

  N/A

  Not Observed

• Delivery Cart is clean and functional (ANSI/AAMI 8.10.2)

  Yes

  No

  N/A

  Not Observed

• Sterile items are covered for transport

  Yes

  No

  N/A

  Not Observed

Safety

• Appropriate eye protection is available when handling chemicals (ANSI/AAMI 4.5.2)

  Yes

  No

  N/A

  Not Observed

• Appropriate Gloves are worn when handling chemicals

  Yes

  No

  N/A

  Not Observed

• Proper body mechanics are used when lifting sets and pushing carts (ANSI/AAMI 8.4.2)

  Yes

  No

  N/A

  Not Observed

• Mittens are worn for burn protection (ANSI/AAMI 8.8.1-8.8.2)

  Yes

  No

  N/A

  Not Observed

• Alarms for EtO are in place and in working order

  Yes

  No

  N/A

  Not Observed

• Staff are monitored on a routine basis for EtO exposure

  Yes

  No

  N/A

  Not Observed

• DART Warm-up performed prior to testing per manufacturer's instructions

  Yes

  No

  N/A

  Not Observed

Bowie Dick / DART

• Performed daily on sterilizers programmed with prevacuum cycle (ANSI/AAMI 10.7.6.1)

  Yes

  No

  N/A

  Not Observed

• Bowie Dick/Dart is placed horizontal on bottom shelf over drain (ANSI/AAMI 10.7.6.3)

  Yes

  No

  N/A

  Not Observed

• Procedure in place for failed tests (ANSI/AAMI 10.7.6.5)

  Yes

  No

  N/A

  Not Observed

• Staff know procedure for failed tests

  Yes

  No

  N/A

  Not Observed

• 3 tests are performed after installation, major repairs, re-location (ANSI/AAMI 10.8.1)

  Yes

  No

  N/A

  Not Observed

• Leak Test performed weekly per manufacturer's instructions

  Yes

  No

  N/A

  Not Observed

Biological Indicator - Process Challenge Device - PCD

• Testing is performed minimally weekly preferably daily (ANSI/AAMI 10.5.3.2)

  Yes

  No

  N/A

  Not Observed

• Each type of cycle is tested - per manufacturer's instructions (ANSI/AAMI 10.5.3.2)

  Yes

  No

  N/A

  Not Observed

• PCD is placed horizontal on bottom shelf over drain (ANSI/AAMI 10.7.2.2)

  Yes

  No

  N/A

  Not Observed

• A PCD is used for each wrapped load (ANSI/AAMI 10.5.4)

  Yes

  No

  N/A

  Not Observed

• BI is incubated in a timely manner (ANSI/AAMI 10.7.2.3)

  Yes

  No

  N/A

  Not Observed

• A control is incubated daily (ANSI/AAMI 10.7.2.3)

  Yes

  No

  N/A

  Not Observed

• Results are read and documented daily in a timely manner. (ANSI/AAMI 10.7.2.3)

  Yes

  No

  N/A

  Not Observed

• Procedure in place for failed tests. (ANSI/AAMI 10.7.5)

  Yes

  No

  N/A

  Not Observed

• Staff know procedure for failed tests.

  Yes

  No

  N/A

  Not Observed

• 3 tests are performed after installation, major repairs, re-location. (ANSI/AAMI 10.8)

  Yes

  No

  N/A

  Not Observed

• Incubators are maintained per manufacturer's recommendations

  Yes

  No

  N/A

  Not Observed

Recall Policy and Procedure

• Recall procedure in place for positive tests and wet loads (ANSI/AAMI 10.11.2)

  Yes

  No

  N/A

  Not Observed

• Staff know recall policy and procedure

  Yes

  No

  N/A

  Not Observed

• Policy and Procedure is based on AAMI Guidelines and facility IC and Risk Management requirements"

  Yes

  No

  N/A

  Not Observed

• No other non-compliances observed.

  Yes

  No

  N/A

  Not Observed

• Responsibility for performing sterilization processes should only be assigned to personnel that are competent in all aspects of disinfection and sterilization procedures as well as safety precautions. Staff should have documented competencies in:

• All phases of decontamination: sorting, disassembly/reassembly, manual and mechanical cleaning methods, microbicidal processes, equipment operation, standard/transmission-based precautions, and engineering and work-practice controls

  Yes

  No

  N/A

  Not Observed

• The operation of all sterilizing systems.

  Yes

  No

  N/A

  Not Observed

• The principles of sterilization and infectious disease transmission; infection control, and all aspects of sterilization.

  Yes

  No

  N/A

  Not Observed

• Staff safety related to medical device processing and sterilization.

  Yes

  No

  N/A

  Not Observed

• Any other opportunities for improvement.

Loaner Trays

• Sterile processing is notified of loaners prior to receiving them.

  Yes

  No

  N/A

  Not Observed

• Instruments are received in facility at least two working days (48 hours) for existing loaner sets and three working days (72 hours) for new sets before scheduled case.

  Yes

  No

  N/A

  Not Observed

• Inventory list is provided/available.

  Yes

  No

  N/A

  Not Observed

• FDA-cleared manufacturer written instructions (IFU) are available for cleaning, packaging and sterilization processes.

  Yes

  No

  N/A

  Not Observed

• Inventory and quality check is completed.

  Yes

  No

  N/A

  Not Observed

• Multiple trays are numbered and labeled (with patient and surgeon).

  Yes

  No

  N/A

  Not Observed

• Trays do not exceed 25 pounds.

  Yes

  No

  N/A

  Not Observed

• All instruments are in good condition, with no rusting or pitting.

  Yes

  No

  N/A

  Not Observed

• Container is in good condition, with no rusting, tape, residue, etc.

  Yes

  No

  N/A

  Not Observed

• Inventory performed prior to returning instrumentation.

  Yes

  No

  N/A

  Not Observed

Start of the SPD Day Cleaning

• Unnecessary equipment/supplies are removed.

  Yes

  No

  N/A

  Not Observed

• Damp dust from the top to bottom: Sterilizers, All reachable flat surfaces (furniture, work tables, shelving, countertops, sinks.

  Yes

  No

  N/A

  Not Observed

SPD Terminal Cleaning

• All floors wet vacuum or single-use mop.

  Yes

  No

  N/A

  Not Observed

• Work tables

  Yes

  No

  N/A

  Not Observed

• Countertops

  Yes

  No

  N/A

  Not Observed

• Sinks

  Yes

  No

  N/A

  Not Observed

• Pass-through window

  Yes

  No

  N/A

  Not Observed

• Computer accessories

  Yes

  No

  N/A

  Not Observed

• Light switches

  Yes

  No

  N/A

  Not Observed

• Door handles and push plates

  Yes

  No

  N/A

  Not Observed

• Telephones and mobile communication devices

  Yes

  No

  N/A

  Not Observed

• Computer accessories

  Yes

  No

  N/A

  Not Observed

• Chairs and stools

  Yes

  No

  N/A

  Not Observed

• Trash and linen receptacles

  Yes

  No

  N/A

  Not Observed

• Housekeeping is performed on a routine scheduled basis (ANSI/AAMI 3.4)

  Yes

  No

  N/A

  Not Observed

• Traffic control limits entry to SPD (ANSI/AAMI 3.2.4)

  Yes

  No

  N/A

  Not Observed

• Staff can describe what IFUs/MIFUs are and where they can find the.

  Yes

  No

  N/A

  Not Observed

• Attire is hospital approved - jewelry is kept to a minimum - no false nails etc. (ANSI/AAMI 4.4-4.5.1)

  Yes

  No

  N/A

  Not Observed

• Personal objects are not stored in SPD

  Yes

  No

  N/A

  Not Observed

• Disposable/Single Use Devices are not reprocessed (ANSI/AAMI 5.3)

  Yes

  No

  N/A

  Not Observed

• Quality checkpoints are in place, documented, assessed and reported (ANSI/AAMI 11.2.1)

  Yes

  No

  N/A

  Not Observed

• Non-conformities are reported by the customer, documented, assessed and reported

  Yes

  No

  N/A

  Not Observed

• Policy and Procedures are up to date and are based on Regulatory Guidelines

  Yes

  No

  N/A

  Not Observed

• Policy and Procedures are adhered to

  Yes

  No

  N/A

  Not Observed

• Staff know and understand Policy and Procedures

  Yes

  No

  N/A

  Not Observed

• Documentation is complete (ANSI/AAMI 10.3.2)

  Yes

  No

  N/A

  Not Observed

• Audits are performed on Documentation to ensure logs are complete and accurate (ANSI/AAMI 11.2.1)

  Yes

  No

  N/A

  Not Observed

• Competencies are in place and performed on a routine basis (ANSI/AAMI 4.3.1)

  Yes

  No

  N/A

  Not Observed

• There is a routine training and in-service plan in place and adhered to (ANSI/AAMI 4.3.1)

  Yes

  No

  N/A

  Not Observed

• Reports of processing outcomes are sent to Infection Prevention and Control Periodically (i.e., IUSS utilization; wet packs, other PI).

  Yes

  No

  N/A

  Not Observed

• No other non-compliances observed

  Yes

  No

  N/A

  Not Observed