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Gap Analysis SPD
Gap Analysis SPD
Memorial Hermann

Gap Analysis SPD

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Free Gap Analysis SPD Checklist

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Title Page

  • Conducted on

  • Prepared by

  • Location

Personnel Considerations

  • Do personnel in the sterile processing area wear clean surgical attire that is provided by and donned at the health care facility and laundered at a health-care-accredited laundry facility? (4.5.1)

  • Are any personnel wearing nail polish and artificial nails in sterile processing areas? (4.4)

  • Is all head and facial hair of personnel covered? (4.5.1)

  • Are any personnel wearing jewelry and wristwatches in sterile processing areas? (4.5.1)<br>

  • Is appropriate PPE worn in the decontamination room (i.e., utility gloves that are fitted at the wrist, liquid- resistant covering, liquid-resistant shoe covers, fluid-resistant face mask/shield and eye protection)? (4.5.2)

Staff Files

  • Ask Manager to view employee file

  • Are all supervisory personnel certified by a nationally recognized certification organization? (4.2.1)

  • Do all sterile processing personnel receive documented orientation training? (4.3.1)

  • Do all sterile processing personnel receive documented continuing education? (4.3.1)

  • Do sterile processing personnel receive in-service training for all new medical devices, cleaning equipment, and sterilizers? (4.3.1)

  • Additional Photos

  • Comments

Preparation and assembly of instruments

Preparation and Packaging Area

  • Magnification and task lighting is available at each station

  • Do personnel verify that the items to be sterilized and any containers or organizing trays are compatible with the sterilization cycle? (8.2)

  • Are instruments positioned to allow the sterilant to come into contact with all surfaces? (8.2)

  • Are instruments disassembled if specified by the manufacturer’s written IFU? (8.2)

  • Are ratcheted instruments unlatched? (8.2)

  • Are tip protectors used in accordance with the manufacturer’s written IFU? (8.2)<br>

  • Is the weight of the instrument set less than or equal to 25 pounds? (8.2)<br>

  • Bottles of alcohol, instrument lubricant, etc. are dated with opened date and are not expired

  • Hinged instruments are opened and/or disassembled and inspected for cleanliness

  • Work area surfaces are clean and/or staff able to verbalize cleaning schedule for work stations

  • Chemical indicators are placed inside each package and on each level of multi-level instrument sets in the area(s) of greatest challenge. Staff able to verbalize procedure and rationale

  • Staff able to demonstrate or verbalize how to inspect lumened instruments

  • Only medical grade paper bags for delicate instruments are used within instrument sets (i.e., plastic/paper peel pouches are not used within instrument sets)

  • Sterile wrap is inspected for defects (e.g., holes or abrasions) or debris prior to wrapping instruments

  • Additional Pictures

  • Comments

Packaging

  • Are packaging manufacturers’ current written IFU available? (9.2)<br>

  • Ask staff how this is performed

  • Can staff pull up an IFU for current instrument?

  • Are packaging policies and procedures based on the manufacturers’ written IFU? (9.2)<br>

  • Is labeling information marked only on the plastic side of paper–plastic pouches? (9.3)<br>

  • Are package closures tamper-evident? (9.4)

  • Are all sterilization packaging FDA cleared for use in health care facilities? (9.5.1, Annex H)

  • Are sterilization wraps stored according to the manufacturer’s written IFU? (9.5.1)

  • Are paper–plastic pouches double-packaged only if validated by the pouch manufacturer? (9.5.4

  • Are paper-plastic pouches used within wrapped sets or rigid sterilization container systems only if the practice is validated by the pouch manufacturer? (9.5.4)<br>

  • If used, are sterility maintenance covers applied when sterilized items are cool and dry? (9.7)

  • Is it verified that sterilization packaging is suitable for the proposed sterilization use and is compatible with the devices and sterilizers in use? (9.8, 10.2.2.1)

  • Additional Photos

  • Comments

Process monitoring, testing, and quality control

  • Is mechanical cleaning equipment tested upon installation, each day it is used, and after major repairs? (13.2)

  • Ask to get copies of logs

  • Is each item in a sterilization load labeled with a control date for stock rotation and with an expiration date or statement? (13.3.2)

  • Are complete sterilization records maintained for each cycle? (13.3.3)

  • Ask to get copies of logs

  • Is every package and sterilization load monitored? (13.4)

  • Is sterilizer efficacy routinely monitored and documented? (13.4)

  • Is qualification testing of each sterilizer conducted after installation, relocation, sterilizer malfunction, major repairs, and sterilization process failures? (13.4, 13.5.3.2, 13.8)

  • Is periodic product quality assurance testing performed? (13.4)

  • Are physical monitoring results checked at the end of each sterilization cycle to verify that all sterilization parameters have been met? (13.5.1)

  • Are chemical indicators used in accordance with the manufacturers’ written IFU? (13.5.2.1)<br>

  • Is an external chemical indicator (process indicator; Type 1 CI) applied to the outside of every package to be sterilized (unless an internal CI can be seen through the package)? (13.5.2.2.1)<br>

  • Is the external chemical indicator on each package checked after sterilization and before use of the contents? (15.5.2.2.1)

  • Is/are an internal CI(s) used within each package, tray, or rigid sterilization container system to be sterilized? (13.5.2.2.2)<br>

  • Are biological indicators used in accordance with the manufacturers’ written IFU? (13.5.3.1)

  • Are biological indicators used within process challenge devices to monitor the efficacy of each sterilizer at least weekly? (13.5.3.2)

  • Is each sterilization cycle type used tested with a BI PCD? (13.5.3.2)

  • Verify that Gravity cycles are tested if programmed on machine

  • Is a process challenge device containing a biological indicator and a Type 5 integrating indicator used to release loads containing implants? (13.5.3.4)<br>

  • If the process challenge device used for routine efficacy testing and qualification testing of sterilizers larger than 2 cubic feet is constructed in-house, does it meet the specifications of ANSI/AAMI ST79? (13.5.4)

  • For commercially available process challenge devices, is it verified that the manufacturer has received FDA clearance for use of the process challenge device in the specific sterilization cycle to be used? (13.5.4)

  • Are there specific criteria for routine load release? (13.6.2) ? Staff

  • Ask staff how this is performed

  • Are loads containing implants quarantined until the biological indicator results are available? (13.6.3) ? Staff

  • Are there specific procedures for the emergency release of implant loads before biological indicator results are available? (13.6.3)? Staff <br>

  • Ask staff how this is performed

  • Are there specific procedures for investigating sterilization process failures? (13.6.4) ? Staff

  • Ask staff how this is performed

  • For routine efficacy monitoring of sterilizers having chambers larger than 2 cubic feet, is the process challenge device placed flat in the “cold point” of the chamber? (13.7.2.3)<br>

  • Each day that test BIs are run, is at least one BI from the same lot used as a control in each incubator? (13.7.2.4, 13.7.3.3, 13.7.4.3)<br>

  • Incubator temperature is within range per manufacturs instructions. Can the staff speak to it???

  • Ask staff how this is performed

  • Is the process challenge device (BI challenge tray) used to monitor gravity-displacement sterilizers placed on the bottom shelf of an otherwise empty chamber? (13.7.4.2)<br>

  • For positive biological indicators, does the microbiology laboratory conduct presumptive identification testing? (13.7.5.1, 13.7.5.3)<br>

  • Are there written policies and procedures for conducting recalls? (13.7.5.2.1) ? Staff<br>

  • Ask staff how this is performed

  • For dynamic-air-removal sterilizers that offer prevacuum cycles, is Bowie-Dick testing conducted and documented every day that the sterilizer is in use, before the first processed load? (13.7.6.1)<br>

  • For qualification testing, are three consecutive cycles run with a biological indicator process challenge device and, for dynamic-air-removal sterilizers that offer prevacuum cycles, three consecutive cycles with a Bowie-Dick test pack? (13.8.1) ? Staff<br>

  • Are policies and procedures in place to evaluate new medical devices for adoption into an existing product family? (13.9.1)<br>

  • Is product testing performed after major changes in packaging or load configuration? (13.9.2)

  • Additional Photos

  • Comments

Sterilization

Instrument Sterilization Area

  • Are there policies and procedures for loading the sterilizer? (10.1.1)

  • Ask staff how this is performed

  • Do all items in a sterilization load have the same cycle parameters (e.g., exposure temperature, exposure time)? (10.1.1)

  • Are paper–plastic pouches placed on edge in relation to the cart or shelf, with paper next to plastic? (10.1.2)

  • Are instrument sets placed horizontally on the sterilizer shelf? (10.1.3)

  • Are textile packs placed on edge, perpendicular to the shelf (not stacked one upon the other)? (10.1.4)

  • Are sterilization container systems and other metal items placed beneath absorbent items? (10.1.6)

  • Are the manufacturers’ recommended sterilization parameters followed for all devices? (10.2.2)

  • Is immediate-use steam sterilization (IUSS) used only in urgent clinical situations? (10.2.3)

  • Are items processed by IUSS decontaminated as specified? (10.2.3)

  • Are rigid sterilization container systems used for devices to be sterilized by immediate-use steam sterilization intended for the IUSS cycle parameters? (10.2.3)

  • Are IFUs followed regarding the cleaning and inspection of the IUSS containers?

  • Do policies and procedures specify that items processed by immediate-use steam sterilization are identified as IUSS and not to be stored? (10.2.3)<br>

  • Are all sterilized items placed on a sterilizer cart or transport tray after removal from a sterilizer with a chamber volume larger than 2 cubic feet? (10.3.1)

  • Do policies and procedures specify when sterilized items can be handled after sterilization? (10.3.1, 10.3.2)

  • During cooling, are the sterilizer carts placed in a low-traffic area and away from air-conditioning or other cold- air vents? (10.3.1)<br>

  • Are sterilized items visually inspected as they are removed from the sterilizer cart? (10.4)<br>

  • Additional Photos

  • Comments

Record Keeping

Record Keeping

  • Request logs for all testing and verify it is complete

  • Testing of Mechanical Washer-Disinfectors: (e.g., TOSI® test)

  • Testing of Cart Washer-Disinfector: (e.g., TOSI® test)

  • Testing of UltraSonic Washers: (e.g., SonoChek®) - Cavitation Test

  • Weekly testing of Eyewash and Shower stations

  • Weekly testing of Chemical status checks: Sinks, Mechanical washers

  • Have staff verbalize how this is performed

  • Daily testing of the PH levels of the water

  • Preventive maintenance (PM) documentation posted for each sterilizer, or is easily accessible

  • Additional Photos

  • Comments

Storage and transportation

  • Are sterile items stored at least 8 inches above the floor, at least 18 inches below the ceiling or sprinkler heads, and at least 2 inches from outside walls? (11.1.1)

  • Are the bottom and top shelves of storage carts or shelving solid? (11.1.1)

  • Is access to the sterile storage area restricted to authorized personnel? (11.1.1)

  • Are there policies and procedures for determining facility shelf life and how it is indicated on sterile items? (11.1.3)

  • Is stock rotated according to the principle of “first in, first out”? (11.1.3)

  • Ask staff how this is performed

  • Is packaging inspected visually for integrity and labeling before an item is issued? (11.2.1)

  • Are all clean or sterile items transported in a closed or covered cart? (11.2.2)

  • Are distribution carts decontaminated and dried before being reused to transport sterile items? (11.2.2)

  • Ask staff how this is performed

  • Do vehicles used to transport sterile items off-site provide for the complete separation of clean/sterile items from contaminated items? (11.3.5)<br>

  • Additional Pictures

  • Comments

Design Considerations

Physical Environment

  • Traffic control: Department traffic is restricted to authorized, appropriately attired personnel

  • Workflow in the department promotes a clear separation of dirty/clean/sterileprocesses

  • Ask staff how this is performed

  • SPD areas are maintained under environmentally controlled conditions (e.g., via FreshLoc® temperature and humidity monitoring system)

  • There are no supplemental fans present in the department

  • Cleanliness of SPD areas: Floors and other surfaces (e.g., walls, ceilings, doors, shelves, equipment) are free of dirt, dust, and debris

  • All area floors and horizontal surfaces are terminally cleaned on a routine schedule

  • Food and drinks are not kept in any SPD area

  • Paper flyers/list are enclosed in protective barrier that allows effective routine cleaning

  • Porous board not present in the department

  • Ask Staff where these are located and how they would exit in case of emergency

  • Fire Extinguishers are present in department and have updated inspection dates

  • Exit Signs are clearly identified and in working condition/ not expired

  • Floors and walls are free of damage

  • Proper negative/positive air pressure in the department

  • Additional Photos

  • Comments

Utilities

Utilities

  • Are there sources of instrument air, vacuum, and distilled or deionized water, as applicable? (3.3.1)

  • Does the facility’s emergency power system include sterilization processing equipment? (3.3.2)

  • Are steam quality, purity, and quantity monitored and maintained? (3.3.3.1)

  • Is steam dryness between 97% and 100%? (3.3.3.2)<br>

  • Are boiler additives and feedwater conditioners monitored? (3.3.3.3)

  • Are there procedures for the preventive maintenance, repair, and monitoring of boilers and steam distribution lines? (3.3.3.4)

  • Is incoming water hardness, pH, alkalinity, and iron content monitored? (3.3.3.4)<br>

  • Is boiler water alkalinity and pH monitored? (3.3.3.4)<br>

  • Is condensate return alkalinity, pH, conductivity, and sulfites monitored? (3.3.3.4)<br>

  • Is there a utility monitoring and alarm system to alert operators to faults or failures of the supplied utilities? (3.3.4)

  • Are floors level and constructed of non-particulate- or non-fiber-shedding materials that will withstand frequent cleaning? (3.3.5.1)

  • Are walls constructed of non-particulate- or non-fiber-shedding materials that will withstand frequent cleaning? (3.3.5.2)

  • Are walls designed to withstand equipment impacts? (3.3.5.2)<br>

  • Are work area ceilings constructed of non-particulate or non-fiber-shedding materials and with a flush surface with recessed, enclosed fixtures? (3.3.5.3)<br>

  • Are doors constructed of durable materials that can withstand equipment impacts and frequent cleaning? (3.3.5.4)

  • Are HVAC parameters monitored and documented by designated personnel in all sterile processing areas? (3.3.5.5)

  • Is the humidity in the sterile storage room as recommended by product manufacturers? (3.3.6.4)<br>

  • Is the lighting of work surfaces designed in accordance with Illuminating Engineering Society of America recommendations? (3.3.5.6)<br>

  • Are handwashing facilities available in all work areas? (3.3.5.7)

  • Is the decontamination room physically separate from all other processing areas? (3.3.6.1.1)

  • If the decontamination area/room is not physically separate from all other processing areas, is there procedural barrier separation, along with appropriate work practices and ventilation? (3.3.6.1.1)

  • Does the decontamination room have a door or pass-through window providing access to the clean work room and is it kept closed? (3.3.6.1.1)<br>

  • Are there enough sinks in the decontamination area to accommodate concurrent soaking, washing, and rinsing? (3.3.6.1.1)

  • Is instrument air available in the decontamination room? (3.3.6.1.1)

  • Is a source of critical water available in the decontamination room? (3.3.6.1.1)

  • Has space been allotted in the decontamination room for the storage of personal protective equipment? (3.3.6.1.2)<br>

  • Are handwashing facilities available in clean areas/rooms? (3.3.6.2)

  • Is the sterilization area designed so that materials flow from the preparation and packaging area to the sterilization area to sterile storage or distribution? (3.3.6.3)<br>

  • Does the sterilization area provide a holding area for cart cooling that is not located with air intake or return ducts? (3.3.6.3

  • If EO sterilization and other forms of chemical sterilization are used, have engineering controls been established to prevent personnel exposure to ethylene oxide and other air contaminants? (3.3.6.3)<br>

  • Is the sterile storage room located adjacent to the sterilization area, preferably in a separate, enclosed, limited- access area? (3.3.6.4)<br>

  • Is emergency eyewash/shower equipment available in all areas where personnel could be exposed to potentially damaging chemicals? (3.3.7)<br>

  • Have staff show logs and perform test

  • Are eyewash/shower facilities tested routinely and documented? (3.3.7)<br>

  • Additional Photos

  • Comments

Receiving

Receiving

  • Are clean or sterile items removed from shipping containers along with any instructions for use before being transported to sterile processing or storage areas? (5.2.1)

  • Ask staff if this is performed and how

  • Are newly purchased and repaired items examined, cleaned, and sterilized before use? (5.2.2)

  • Ask staff if this is performed and how

  • Are new or repaired instruments with moving parts examined for defects? (5.2.2)

  • Ask staff if this is performed and how

  • Is there a formalized program and policy for the receipt, processing, and use of loaned instrumentation? (5.2.3)

  • Ask staff if this is performed and how

  • Are loaned instruments cleaned, decontaminated and sterilized prior to use? (5.2.3.4)

  • Ask staff if this is performed and how

  • Are rigid sterilization systems inspected and cleaned and decontaminated before use? (5.2.4)

  • Are reusable items that have been issued but not used reprocessed if the packaging has been damaged? (5.3)

  • Additional Photos

  • Comments

Handling, Collection, and Transportation of Soiled Instruements

  • Are waste and reusable items separated at the point of use? (6.2)

  • Is gross soil removed from instruments at the point of use? (6.3.2)

  • Are contaminated items kept moist during transport? (6.4)

  • Are instruments needing repair identified? (6.3.5)

  • Are all containers, devices, or carts used for containing contaminated items OSHA compliant? (6.4)

  • Are clean/sterile items segregated from contaminated items during transport? (6.5.1)

  • Are carts and containers used for the transport of contaminated items decontaminated after each use? (6.5.3)

  • Additional Photos

  • Comments

Cleaning, disinfection (microbicidal processes), and other decontamination steps

  • Are policies and procedures available for all methods of cleaning and decontamination? (7.2)

  • Have staff show IFU access and comprehension

  • Are the manufacturer’s written instructions for use accessible, reviewed and followed for every device that will be processed in the decontamination area? (7.3)

  • Are instruments inspected for flaws, damage, debris, detergent residue, and completeness before being packaged for sterilization? (7.4.1)

  • Are instruments presoaked before being cleaned? (7.5.1)

  • Are general operating instruments separated from delicate instruments before cleaning? (7.5.2.1)

  • Ask staff to verbalize brush size usage and when do they replace them

  • Are lumened devices cleaned with brushes of the size recommended by the device manufacturer? (7.6.2)

  • Is it verified that cleaning agents are compatible with devices to be cleaned? (7.6.3)

  • Is it verified that cleaning agents are compatible with the cleaning equipment to be used? (7.6.3)

  • Are PPE and work practices reviewed whenever a new cleaning agent is introduced? (7.6.3)

  • Are all immersible devices cleaned under water? (7.6.4.2)

  • Does the quality of water used for rinsing comply with the device manufacturer’s IFU? (7.6.4.2)

  • Is critical water used for the final rinse? (7.6.1)

  • Ask staff how devices are ultrasonic and how often the utilize machine. When do they replace the water

  • Is gross soil removed from devices before they undergo ultrasonic cleaning? (7.6.4.4.1)

  • Is the cleaning process verified? (7.6.4.5)

  • Are rigid sterilization container systems decontaminated in accordance with the manufacturer’s IFU? (7.5.2.2.1)

  • Additional Photos

  • Comments

Quality process improvement

  • Is there an ongoing process for verifying compliance with policies and procedures? (14.5)

  • Is there a docmented Internal and External disaster plan?

New product evaluation

Sterilization Wrap

  • Is there a multidisciplinary committee responsible for evaluating new products being considered for purchase? (15.2)

  • Is the manufacturer’s written IFU reviewed before purchase of a product? (15.2)<br>

Additional Photos

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Gap Analysis SPD
Memorial Hermann

Gap Analysis SPD

Use this Template
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