A Risk Assessment Approach to Categorize High-Level Disinfection Gaps Across the Healthcare Enterprise

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      Endoscope reprocessing is a multi-step process and gaps can impact the efficacy of the disinfection process. An increase in breaches with high-level disinfection (HLD) processes was reported to infection prevention. Upon further investigation, it was realized the number of departments performing HLD had increased, the types of devices reprocessed increased, and procedural variation existed, sometimes within the same department. A lack of defined quality assurance, process improvement (QAPI) existed whereby, the burden of this problem across the organization was not realized.


      An organizational risk assessment and inventory of devices were convened. The risk assessment tool was designed utilizing a hazard vulnerability approach (HVA) with a scoring methodology. The criterion used was based on manufacturer guidelines, regulatory requirements, and recognized industry experts. Hospital-based Infection Preventionists (IP) convened a team to complete the risk assessment. The senior IP and epidemiology team collated the information with a detailed report presented to the corporate level quality and safety committee.


      One hundred forty-two locations were performing HLD, encompassing 22 service lines and at least 10 different types of devices. Examples of locations included speech therapy, women's health, and urology. Primary risks identified by the HVA included inappropriate transport of devices, lack of environmental controls, and gaps in the pre-treatment of devices at the point of care. Secondary risks included gaps in leadership with HLD oversite, variation in policies, disposal of waste, and documentation, primarily gaps in logs. Device-specific audit tools were created with a monthly HLD audit cadence that is now included within the infection prevention program plan and QAPI.


      This risk-based and HVA illustrated the scale and risks of this decentralized procedure and processes. Tight controls such as standard audit tools with a focused infection prevention QAPI process to report monthly compliance or gaps thereof are needed for these complex disinfection protocols.
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