Eight Opportunities for Improving HLD and Sterilization Practices in Hospitals
Consistent and compliant sterilization and high level disinfection (HLD) processes throughout an organization are neither simple nor easy to manage. According to The Joint Commission, it was the top hospital non-compliant scored standard in 2019, and will consequently remain a focus during accreditation surveys. Processing of equipment and instrumentation requires the expertise and collaboration of many departments. A diligently executed management plan increases the likelihood that industry standards are consistently met and that risks to patient safety are minimized.
Reusable equipment like transesophageal echocardiogram (TEE) and ultrasound surface probes, ophthalmology and dental instruments, are often used in inpatient areas outside the main OR and sterilization processing department (SPD), clinics, and other outpatient areas. Often these areas use steam sterilization or high-level disinfection that may not meet law and regulation, manufacturer’s instructions for use (IFUs) or nationally recognized evidence-based guidelines. In addition, competency, training, and education may be inconsistent or lacking, and quality control processes may fail to follow the manufacturer’s IFUs.
While even assessing the quality level of your organization’s high-level disinfection and sterilization practices can prove difficult, here are eight opportunities any organization can take to improve.
1. Location, Location, Location
Organizations often overlook the creation and maintenance of a current, accurate, and comprehensive list of areas performing sterilization and high-level disinfection within their walls. This is especially common when HLD and sterilization processes have been decentralized, with no individual, department, or committee assigned oversight responsibility. Assignment of oversight responsibility is a must. Once determined, work can begin to identify all locations where sterilization or HLD is being performed, and decisions to reduce, maintain, or expand these locations can be made.
Not sure where to begin? Start with the Bio-Medical Engineering department. This department usually maintains a list of all sterilizers and HLD equipment such as a Trophon or TD-100 unit. Most Bio-Medical departments also include the location of the unit and the last date of preventative maintenance. Another resource is the Materials Management department, who can usually produce a list of any department that has ordered high level disinfection solutions, such as Cidex® OPA.
The department or person responsible for coordinating accreditation or regulatory surveys can be another valuable resource, as they can provide a list of all areas eligible for survey. Every department on the list should be contacted about their sterilization and high-level disinfection activity. This list can become the foundation for your HLD/sterilization database. Because this information is continually subject to change, it should be routinely verified for accuracy. Be sure to include all devices such as endoscopes, ultrasound and TEE probes in this inventory.
2. Follow the manufacturer’s instructions for use (IFUs).
Medical/Surgical equipment, devices, and supplies (such as ultrasound surface probes, pre-cleaning, and cleaning products used in decontamination) come with manufacturer’s IFUs. Following manufacturer’s IFUs is not optional. IFUs for ultrasound surface probes dictate that a probe should undergo HLD processing after coming into contact with non-intact skin, despite use of a probe covers or sheaths during procedures. Cleaning product soak times and solution temperatures should be adhered to without variation to ensure the process produces the desired result.
It can be difficult for staff to commit the requirements to memory. Instructions are more likely to be followed if they are readily available. Placing the manufacturer’s instructions for use in a central online portal or reference binder for easy access and retrieval and posting reminder signage in the work area make it easier for staff to do the right thing.
3. Standardize sterilization/HLD processes across the organization.
To ensure that standardized processes are implemented in each sterilization/HLD area, nationally recognized evidence-based guidelines and manufacturer’s IFUs should be used for sterilization, HLD of endoscopes, and HLD of other devices.
Evidence-based guidelines for high-level disinfection of endoscopes and other devices:
- CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
- AORN Perioperative Guidelines for Manual Chemical High-Level Disinfection, and Flexible Endoscopes. 2020
- SGNA Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes, 2016
- Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update
- ANSI/AAMI ST91: Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities, 2015
- ANSI/AAMI ST58:2013/(R)2018: Chemical sterilization and high-level disinfection in health care facilities
Evidence-based guidelines for sterilization:
- ANSI/AAMI ST79: 2017. Comprehensive guide to steam sterilization and quality assurance in health care facilities
- AORN Perioperative Guidelines for Sterilization, 2020
- AORN Perioperative Guidelines for Cleaning and Care of Surgical Instruments, 2020
- CDC(2008): Update May 2019. Guideline for Disinfection and Sterilization in Healthcare Facilities
4. Standardize pre-cleaning at point-of-use and transportation to decontamination.
Pre-cleaning at point of use encompasses instruments and devices such as endoscopes and probes. Locations include ORs, ICUs, ambulatory clinics, and off-site locations. Key stakeholders such as Central Sterile Processing, Infection Prevention and Control, clinicians, products review committees, and management/leadership are vital in decision making for potential product selection and transport containment to meet the needs of the entire organization, while following laws, regulations, IFUs, and evidence-based guidelines.
- Transport containment should be leak proof, puncture-resistant, biohazard labeled, based on the contents being transported.
- Pre-cleaning instructions and process steps are provided by manufacturer’s IFUs and selected evidence-based guidelines. Pay close attention to product IFUs for contact time and PPE requirements.
- Display simple visual aids for staff that illustrate the step-by-step processes and monitor these processes for compliance.
5. Document quality control processes.
Surveyors often check the staff’s knowledge regarding quality control processes, like quality control test strip immersion time and timing requirements for reading accuracy. This information varies among products and manufacturers, so attention to the test strip bottle labeling is important. The open date of test strip bottles should be recorded, as well as their expiration dates, which should never exceed the manufacturer’s expiration date (also routinely noted). Quality control testing must be done exactly as recommended by the manufacturer and documented in the quality control log. Visual aids in the work area are recommended for easy reference of this very specific information. Sterilization parameters include reading and documenting the following: physical or mechanical monitoring, chemical indicators, and biological indicators. Assure that documentation is being audited routinely to detect omissions or inaccuracies.
Documentation logs should include all recommended elements required by selected sterilization or HLD evidence-based guidelines. Often, HLD logs lack required elements, such as a patient name and identifier, physician, and unique probe identifier. The steam sterilizer or automated processing unit printout may be attached to the log but does not include the signature or initials of the person performing the quality monitoring parameters. Refer to selected evidence-based guidelines for a complete list of data elements required for sterilization and HLD to be sure your logs contain all required elements.
6. Store devices properly after HLD.
Devices such as endoscopes, ultrasound and TEE probes that have been processed using HLD are to be stored in a manner that minimizes contamination. Storage may include storage cabinets, or probe storage covers that are indicated for storage. Follow selected evidence-based guidelines, and device manufacturer’s IFUs for storage. Follow storage cabinet IFUs for routine cabinet cleaning.
7. Ensure sterilization/HLD competency assessments are performed by a qualified person.
The Joint Commission standard HR.01.06.01, EP 3 requires “an individual with the educational background, experience, or knowledge related to the skills being reviewed assesses competence.” For example, individuals certified by the Certification Board for Sterile Processing and Distribution, Inc. (CBSPD) or the Certification Board of Infection Control & Epidemiology, Inc. would meet the criteria for educational background, experience, or knowledge. Organizations should be able to demonstrate that the persons assessing HLD and sterilization competence are qualified to do so.
8. Ensure consistent compliance with oversight.
An effective oversight and monitoring system ensures sustained compliance throughout the organization. The most critical element is clearly establishing the person, committee, or team responsible for ensuring the oversight, monitoring activities, and corrective action (when necessary). Each organization must consider how to establish oversight responsibility. This function should be integrated into the organization’s Quality Assurance and Performance Improvement program. In addition, sterilization and HLD should be risk assessed by Infection Prevention and Control. Based on risk prioritization, these processes may be part of the Infection Prevention and Control Plan.
Elements of an effective oversight program include frequently scheduled rounds or tracers to include off-site locations, with the submission of findings to the oversight body, management, and leadership for review on a routine basis. Staff responsible for reviewing the quality control and processing logs should submit their findings to an established committee, such as the Infection Prevention Committee or the Environment of Care Committee to link these activities to the organization’s quality program.
TiER1 Healthcare can help.
TiER1 Healthcare can help your team form a complete approach to infection prevention and assist with your high-level disinfection and sterilization processes. Contact us at (800) 241-0142 or email@example.com for consultation.
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