1. Tracing Sterilization April 26, 2019
Mary Cole, MSN, CJCP, CIC
Consultant
Joint Commission Resources, Inc.

2. Publications and Record Restrictions
Copyright © 2019 by Joint Commission Resources, Inc. All rights reserved. No part of this publication may be reproduced in any form or by any means without written permission from the publisher. Request for permission to make copies of any part of this work should be addressed to However, the use of these materials for commercial purposes is restricted to JCR and may not be used by any other party or entity.

3. IC.02.02.01 Medical Equipment, Devices, and Supplies
The hospital reduces the risk of infections associated with medical equipment, devices, and supplies – implements infection prevention and control activities

4. IC.02.02.01 Medical Equipment, Devices, and Supplies
Low level disinfection
Intermediate and high level disinfection and sterilization
Disposal
Storage
Reprocessing single-use devices

5. Spaulding Classification

6. #1 most frequently cited clinical standard
#1 issue in Immediate Threat to Life

7. Sterilization

8. Approach to IC-Related Standards
Regulation (i.e. OSHA)
Condition of participation – if deemed
Manufacturer instructions
Evidence-based standards or guidelines
Consensus documents or position papers
Incorporate into facility-based risk assessment and policy

9. Point of Use Procedure completed
Precleaning with water or a product recommended for pre-cleaning with manufacturer’s instructions- for-use followed, that is applied at point-of-use to remove blood, body-fluids, and bioburden from items that are to be re-processed based on manufacturer’s instructions-for-use and evidence- based guidelines

10. Transport To Decontamination Area
Items are contained to protect the transporter and others from contents within the container
Items are to be kept moist during transport to prevent hardening of blood, body fluids, or bioburden
The type of container used is based on what is being transported
All containers must be leak-proof, puncture-proof, and labeled as biohazardous
Examples: bins with lids, impermeable bags, etc.

11. Transport to Decontamination Area
Frequent Findings
Surgical instruments were not transported from the point of use to the soiled utility room in a leak proof puncture resistant container with the biohazard symbol or color red in accordance with policy.
Facility did not follow manufacturer’s instructions for use and/or evidence-based guidelines identified by the organization to transport soiled instruments
Soiled surgical instruments were not transported in accordance with facility policy.
Staff were not following the organizations defined step by step process for handling and transporting soiled instruments for example: Staff were transporting dirty instruments in an open tray covered with a towel.
This is a paraphrases of frequent survey findings

12. Transport to Decontamination Area
What can you do to ensure compliance?
Ensure compliance with OSHA regulations
Review manufacturer instructions for specialty equipment
Choose evidence based guidelines and standards carefully
Perform a risk assessment
Write a policy that can be implemented and enforced based on regulation, manufacturer instructions, and chosen evidence based guidelines and national standards
Standardize training and competency assessment for staff using the instruments, regardless of setting
Hold staff accountable
This is a paraphrases of frequent survey findings

13. Clarification From SIG

14. Clarification From SIG

15. Environmental Controls
Temperature
AAMI: 18°C to 24°C [65°F to 75°F]
Humidity
AAMI: 30% to 60%
Airflow
© Sylvia Garcia-Houchins
Physical factors such as temperature, humidity, air exchanges, ventilation exhaust, adequate space and equipment can also affect the disinfection and sterilization process. Physical properties of CSP and decentralized reprocessing areas should meet local building code requirements as well as specific requirements established by the manufacturer’s of equipment and supplies used in these locations. In the absence of local guidance the following physical areas are recommended.
© Sylvia Garcia-Houchins
© Sylvia Garcia-Houchins

16. Ventilation Risk point Teach staff to own their work area
Areas can pass regular testing and be non-compliant at survey
Teach staff to own their work area
Expected airflow
Testing process
Identify weaknesses in the environment
Identify variables in workflow

17. Cleaning Detergent dilution Manual Ultrasonic Follow IFU’s
Remove all parts
Rinse
Inspect

18. Cleaning Agents Follow IFU’s
Volume and temperature of water is essential to the efficacy of the product
Change solution after every use
Monitor water temperature per IFU’s

19. In Decontamination Setting
Personal Protective Equipment (PPE) is worn and includes:
Hair covering/cap
Face mask/shield
Fluid resistant gown
Gloves used should be durable to prevent tearing and leaking of chemicals and/or contaminated fluids when the user’s hands are under water
Note a distinct flow and separation of dirty and clean processes that minimizes the risk of cross- contamination

20. Decontamination Cleaning Process Demonstrate Labeling of sinks
Standard work with low/no variation
Job aids

21. Decontamination Manual and or mechanical
Brushes reusable or disposable
Ensure entire instrument is disassembled, cleaned and rinsed including valves, channels, connectors and all detachable parts in accordance with manufacturer’s instructions
© Sylvia Garcia-Houchins

22. Separation of Clean and Dirty

23. Preparation of Instruments
Cleaned
Dried
Inspected for cleanliness, flaws, and damage, assembled
Packaged according to the manufacturer’s written IFU

24. Table Top Sterilizers Mostly used in clinics, dental specifically
Water quality is very important
Review and follow IFU’s

25. Sterilization
The choice of sterilant must be in compliance with manufacturer’s instructions for both the device or instrument and the sterilizer. The sterilization process must be monitored using chemical, biological, and physical indicators as outlined by the manufacturer.

26. Sterilization
Cleaning, maintenance, and record keeping/documentation of sterilizer(s) based on manufacturer’s IFU
Cycles of sterilizer – test all cycles that your sterilizer is capable of performing regardless of the cycle you use most often

27. Steam Sterilization
Is the most commonly used process for sterilizing instruments, trays, and cassettes
According to the CDC, steam under pressure is the process of choice whenever possible as it is considered safe, fast, and the most cost-effective for health care facilities
Steam sterilizers come in many different sizes, and sterilizer cycles can vary among manufacturers.

28. Steam Sterilization Items to be sterilized must be:
Clean and free of protein (blood) or other organic material
Packaged so that the steam can penetrate
Loaded correctly

29. How Do You Ensure Proper Sterilization?
Physical monitoring
Chemical indicators
Biological indicators

30. Air Removal (Bowie Dick, DART)
An air removal test designed to detect inadequate air removal in pre-vacuum sterilizers.
Air not removed from the sterilizer chamber prevents steam from contacting the items in a load and therefore interferes with sterilization.
Follow manufacturer instructions for how to perform the test and frequency of testing.
If a sterilizer fails the air removal test, the sterilizer should not be used until it passes inspection by sterilizer repair personnel.

31. Physical Monitoring
Involves checking the sterilizer gauges, computer displays, or printouts
Documenting in your sterilization records that pressure, temperature, and exposure time have reached the levels recommended by the sterilizer manufacturer
Since these parameters can be observed during the sterilization cycle, this might be the first indication of a problem

32. Chemical Indicators (CI)
Important to note that CIs alone do not confirm that an item is sterile
Uses sensitive chemicals that change color when exposed to high temperatures or combinations of time and temperature
External and internal indicators
Should be used for every item sterilized regardless of type of container or packaging
Indicators should be placed in the location specified by the indicator and container manufacturer

33. Chemical Indicators
A chemical indicator should be used inside every package to verify that the sterilizing agent has penetrated the package and reached the instruments inside
If the internal chemical indicator is not visible from the outside of the package, an external indicator should also be used.
Chemical indicators help to differentiate between processed and unprocessed items, eliminating the possibility of using instruments that have not been sterilized

34. Biological Indicators (BI)
Provide a defined resistance to the sterilization process
BI results must be acceptable in order for an operator to use the sterilizer to produce sterile goods
AAMI recommends running a biological a minimum of once per week, many facilities run one every day

35. Biological Indicators (BI)
Run with all loads containing an implantable device
May also be adversely affected by air leaks and air that the vacuum system has failed to remove

36. Common Findings With Sterilization
Not pre-cleaning at point-of-use
Quality monitoring parameters (physical, chemical, and biological) not being consistently conducted or documented as per manufacturers’ instructions for use or evidence-based guidelines
Approximating use of cleaning products with no means of accurate measurement; not following manufacturers’ instructions for use

37. Common Findings With Sterilization
No documentation reflecting routine cleaning or preventative maintenance of the sterilizer(s)
Lack of standardized processes for cleaning the same types of equipment
Inconsistent or lack of staff orientation or on-going training on sterile processes

38. Common Findings With Sterilization
Lack of a process to document or follow-up on equipment failures
Not following sterilization evidence-based guidelines

39. Disassembly of Instruments
Gaskets should be removed, stopcocks opened, and instruments should be completely disassembled as specified by the instrument manufacturer’s instruction during the cleaning and sterilization process
Rib spreader, gomco
Risk assessment

40. Hinged items
Hinged items are to be opened to assure access to proper cleaning

41. Peel Packs
Peel packs should be sized to prevent tearing during movement or storage.
Items should be packaged to ensure that sterilant can contact all surfaces.

42. Peel Packs
Double peel-packs are used as indicated by the manufacturer instructions for use, with evidence- based guidelines being followed.
No folding over of the inner paper/plastic peel pack, as this may prevent the sterilant from contacting the contents of the package
Use the proper size pouch for the proper instruments

43. Peel Pouches
Pouches should be sized to prevent tearing during movement or storage.
Items should be packaged to ensure that sterilant can contact all surfaces.

44. What Is Wrong With This Picture?.
Photo by Sylvia Garcia-Houchins, RN, MBA, CIC

45. What is Wrong With This Picture?
If double pouching is performed, it must be validated by the manufacturer.
Photo by Sylvia Garcia-Houchins, RN, MBA, CIC

46. Labeling Sterile Products
Label should
Not compromise the barrier
Include
Contents
Date sterilized
Identifier that allows the item to be tracked back to the sterilization load
© Sylvia Garcia-Houchins
© Sylvia Garcia-Houchins
© Sylvia Garcia-Houchins
© Sylvia Garcia-Houchins

47. Reprocessing Single Use Devices
IC , EP 5: When reprocessing single- use devices, the organization implements infection prevention and control activities that are consistent with regulatory requirements and professional standards.
In other words, before a device intended for one use or use on a single patient during a single procedure can be reprocessed and reused, a third party or a health care facility must comply with the same requirements that apply to original equipment manufacturers.

48. Reprocessing Single Use Devices
Because most health care organizations cannot meet these rigorous requirements, the majority should either use a third party reprocessor that can meet the requirements or choose not to reprocess and reuse SUDs.
The organization would benefit from a clearly written policy and the infection preventionist can be a valuable collaborator in developing the policy.

49. Points to assess Storage of Sterile Trays
Segregation of Sterile and Unsterile
Visual cues
Workflow, Traffic, and Access Control
Temperature & Humidity
Airflow
Alternate storage sites OB
‘Sterile’ Core
Hallways

50. Storage of Sterile Items
Protect sterility until ready to use
Store to protect packages from dust, moisture, falling on floor
Transport only covered, dry packages
Handle to protect package integrity
Rotate sterile items first in, first out
Store and label for effective recall system
Expiration date vs. event-related sterilization

51. Storage
Dust covers may be used to protect sterilized items that could be subjected to environmental challenges or excessive handling before use

52. Storage AAMI recommends sterile items be stored
at least 8 inches off the floor
18 inches below ceiling or sprinkler
2 inches from outside wall
away from any location where they could become wet

53. Storage of Critical Devices
If open shelves are used, traffic control, ventilation, and housekeeping should be monitored
Bottom shelves should be solid to prevent soiling when floors are cleaned
Covered or closed cabinets limit dust and are preferred for seldom-used items

54. Storage of supplies
Supplies, including those in rigid containers, should not be stored next to or under sinks, under exposed or open water or sewer pipes, or in any location where they could become wet.
All items in clean storage rooms should be clean (no soiled items), and clean items should not be stored in soiled rooms.

55. Storage of supplies
Clean and sterile items should be removed from their external shipping containers before they enter storage areas, because the containers may have been exposed to unknown and potentially high microbial contamination during shipping, and may serve as generators of and reservoirs for dust and vermin
Outside shipping containers and corrugated boxes should not be used as containers in sterile storage areas.

56. IC.02.02.01 EP4 Common Findings With Storage
No barrier on bottom shelf
Peel pack issues
Hang time of scopes outside of policy
Instruments outside of or opened peel pack with no clear process

57. Compliance Tips Review your current processes (tracers)
Revise protocols that cover equipment reprocessing effort, including
Transporting items to be cleaned
Cleaning and decontamination
Sterilization
Storing or immediate use
Review manufacturers recommendations
Provide training and ongoing observation

58. Sterile Processing is a Team Sport
Work with Engineering/ Facilities
Who monitors temp/humidity/pressure?
Do you follow AAMI, AORN, ASHRE, FGI?
Is it documented consistently?
Can staff speak about it? Do they know who to contact if there is a problem?

59. Sterile Processing is a Team Sport
Can maintenance documents be produced promptly?
Who is responsible for checking eye wash stations?
What is the condition of the surfaces? (counters, floors, walls)

60. Sterile Processing is a Team Sport
Work with EVS
Do they have access areas to clean daily?
Who is responsible for cleaning what? (vents)
If there is a consistent EVS employee, what about when they are out?
Is there a checklist or sign off? Audit process?

61. Emergency Situations for Early Release
Emergency situations should be defined in written guidance, developed in consultation with infection prevention and control, the surgeon, the OR manager, and risk management.
Steps should be taken to reduce the frequency of emergency releases of implantable items.

62. Additional Risks for Reprocessing
Immediate Use Steam Sterilization (IUSS)
Vendor Trays
Emergent and Add-on Cases

63. Contracted Services
Contracted services for equipment / loaner instrumentation
How are these services tracked and monitored?
Does equipment / loaner instruments arrive in sufficient time to reprocess?

64. Standardize Work Practices
Determine process/best practice – standardize to it
Involve frontline staff
Develop P&P
Train/re-educate
Follow-up to assure sustainability and provide feedback

65. Education and Competencies
Upon hire
Recommend at least annually
Whenever new item or equipment
borrowed
leased
purchased
Whenever new policies and procedures are implemented

66. Education and Competencies
Determine frequency of competency and training based on staff turnover, purchasing new equipment or products, or a breach in the process has been identified
Random observations
Who signs off on competencies?
Who signed them off?

67. Education Training should include:
Principles of cleaning, disinfection and sterilization
Inspection, preparation, and packaging of instruments
Worker safety and use of personal protective equipment (PPE)
Manufacturer’s instructions for use
Quality control of processes
Endoscope model-specific cleaning and disinfection, if applicable

68. Training and Competency
Training is NOT equivalent to demonstrated competency
Competency is ability of the individual to perform specific tasks in accordance to the standards that are required

69. HLD & Sterilization BoosterPak®
Available for accredited organizations on the organizations extranet site, including Guest Access
Applicable to hospitals, critical access hospitals, ambulatory, and office-based surgery settings
Excellent source for teaching and policy development

70. HLD & Sterilization BoosterPak®
Targeted audience:
Frontline staff conducting HLD and sterilization
Supervisor/manager of HLD and sterilization
Infection Preventionists
Goal:
To ensure HLD and sterilization practices are conducted according to regulatory standards and evidence-based guidelines, to minimize the potential risk of infection to patients

71. Questions or Comments?
Thank you!