By Sylvia Garcia-Houchins, RN, CIC, director of infection prevention and control, The Joint Commission
After a careful evaluation of high-level disinfection (HLD) and sterilization process steps, The Joint Commission has refined its scoring as of September 1 to focus on the process steps that pose the highest risk to patients if they fail.
Last year, 72 percent of surveyed hospitals and critical access hospitals were found to be noncompliant with The Joint Commission’s high-level disinfection and sterilization standard IC.02.02.01. We are refining some of the scoring guidelines to clarify expectations.
Seven areas have scoring revisions specific to High Level Disinfection—the common theme is establishing processes that support manufacturers’ instructions.
The Joint Commission will continue to score IC.02.02.01 as noncompliant whenever manufacturer instructions are not followed. Over the next several months, we will closely monitor the revisions to ensure consistent scoring.
Wipe & Flush at Point of Use, As Needed
There is no expectation that visible blood or tissue be removed from instruments at the point of use.
Clinically appropriate wiping/flushing of soiled instruments may be observed during a case in the operating or procedure room. Facilities may be asked about their wiping/flushing policy, but there’s no expectation that all instruments will be wiped or flushed. Instrument cleaning should be performed in the decontamination area with appropriate personal protective equipment (PPE), facilities and other equipment that will protect employees from possible exposure/ injury.
Organizations will also be scored if an instrument that is ready for use on a patient is visibly soiled.
Surveyors may ask staff to:
watch the case being opened
describe what they check for when opening a tray
open a tray that will not be needed for 24 hours
explain what they would do if they found an instrument with bioburden when opening a sterile pack or tray.
Maintain the Moisture of Soiled Instruments
The facility may choose the manner in which it keeps soiled instruments moist. The Joint Commission requires that a process is in place to maintain moisture, as recommended by the instrument manufacturer, the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of perioperative Registered Nurses (AORN). The process and product choice are the organization’s decision.
containers that maintain moisture,
products for maintaining moisture in accordance with manufacturer instructions
Transporting Soiled Instruments Safely
Non-sharps must be transported in a way that cannot lead to contamination.
Occupational Safety and Health Administration (OSHA) states reusable sharps must be placed in a puncture-resistant red container or one marked “biohazardous”, and this requirement is reflected in the refined scoring guidelines.
AAMI provides reasonable guidance on transportation and the issue of bottom or side leaks on crash carts in section 6.5.3 Transportation Equipment, if you’ve purchased the manual. In a nutshell, carts need to be appropriate for transport of the items being moved. If the instruments are in containers with solid sides and bottom and are covered, an open cart may be appropriate. If the items are placed in open bins and then on an open cart, the organization should use a cover for the cart. Items in closed case carts do not need to be covered.
The cart should be designed to prevent items from falling off. Surveyors may ask infection control/operating room and Central Sterile Processing management if they have evaluated that risk and if items have ever fallen off.
Ensuring the Sterilant Reaches All Surface
All surfaces of the instruments undergoing sterilization must be accessible for the sterilant to reach them. Manufacturer instructions provide information on how to prepare items for sterilization. In addition, AAMI and AORN state that items should be sterilized in the open (unratcheted) position and disassembled in accordance with manufacturer instructions.
We recognize that some instruments, such as scissors, are likely to close after sterilization when they are being transported or stored. Therefore, surveyors will review the process for ensuring the item is prepared in a manner that will ensure exposure to the sterilant. Surveyors will observe the instruments coming through the cleaning process to ensure that they have been disassembled and are packaged in accordance with manufacturer instructions. They will also review peel packs to see if items that are awaiting sterilization or have just been sterilized are in the unratcheted position.
In order to ensure accurate scoring, surveyors may ask for manufacturer instructions for use to confirm whether an item should be taken apart.
Surveyors may ask staff to prepare a tray from those waiting to ensure instruments are opened and inspected during assembly. They will be watching how staff checks for cleanliness of instruments that are being processed. In some cases, staff may be asked to open a rigid or wrapped tray awaiting sterilization to confirm that items are being opened or disassembled in accordance with manufacturer instructions.
Careful Instrument Release after Sterilization
Instrument release should be a thoughtful and deliberate process to ensure only sterilized items are released.
Internal and external, if the internal indicator is not visible through packaging, chemical indicators must be used for every item undergoing sterilization. Physical monitoring of cycle (e.g., time, temperature, and pressure) and a check of the external (or internal if visible through the packaging) chemical indicators must occur before each non-implant load is released. Implant loads may be released after all of the following actions:
verification that the physical parameters of the sterilization cycle have been met
a biologic indicator has been done and is negative
a type 5 integrating indicator (aka integrator) confirms the process.
Unless there’s a facility policy allowing emergent release of implant loads before the biologic indicators is read, surveyors will score as not compliant with the standard if the result of the biologic is not recorded prior to use. If a facility policy does allow individuals to proceed without reading the biological indicators in emergent situations, the policy must be followed.
Storage of Items that have undergone High Level Disinfection, including endoscopes and endocavity probe
Items must be stored in a way that’s consistent with their intended use. This means that items that require a minimum of high-level disinfection may be stored in a way that protects from contamination even if they were sterilized.
Again, manufacturers’ instructions for use must be followed for storage. If instructions for use do not provide direction on storage requirements, items should be stored in a way that prevents contamination. Surveyors will score based on compliance with facility policy or risk assessment unless the manufacturer’s instructions for storage were not followed, or the containers/ locations of storage are visibly soiled, or if staff are observed contaminating other high level-disinfected products.
Dry Endoscopes Before Storing
Recent articles have indicated that a key component of ensuring that microorganisms do not replicate during storage is careful drying – not the duration of storage. Surveyors will check for compliance with manufacturers’ instructions for drying scopes. but will no longer score any finding related to hang time unless a reprocessing frequency has been specified by the endoscope manufacturer and is not followed.
Any IC02.02.01 findings on survey before September 1 will not be removed. Hospitals that are in the clarification window or that are preparing their Evidence of Standards Compliance (ESC) report should document compliance based upon the refined scoring guidelines. If you believe that your organization received an adverse decision based solely on a finding that would no longer be scored, please contact the Standards Interpretation Group via the online form or email me directly.
We want the survey process to be as transparent as possible and hope that scoring refinements will help organizations focus their efforts on keeping patients safe!