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.