567.3 Policies and procedures
(b) Current written policies and procedures to assure definite and
valid infection control shall include,but not be limited to, the
following:
(3) Sterilization and disinfection, including suitable equipment for routine and rapid sterilization.
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Observations:
Based on tour and observation, review of nationally-recognized standards for sterilization and disinfection, facility documents, and interview with staff (EMP), it was determined the facility failed to ensure laryngoscope blades were cleaned with a high-level disinfectant.
Findings include:
Review of nationally recognized standards for sterilization and disinfection document, Center for Disease Control's "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, last updated May 2019," revealed "Definition of Terms: Sterilization describes a process that destroys or eliminates all forms of microbial life and is carried out in health-care facilities by physical or chemical methods. ... Disinfection describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects ... In health-care settings, objects usually are disinfected by liquid chemicals or wet pasteurization. ... Factors that affect the efficacy of both disinfection and sterilization include prior cleaning of the object ... Unlike sterilization, disinfection is not sporicidal ... Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. ... Semicritical Items Semicritical items contact mucous membranes or nonintact skin. This category includes respiratory therapy and anesthesia equipment, some endoscopes, laryngoscope blades ... These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible. Intact mucous membranes, such as those of the lungs and the gastrointestinal tract, generally are resistant to infection by common bacterial spores but susceptible to other organisms, such as bacteria, mycobacteria, and viruses. Semicritical items minimally require high-level disinfection using chemical disinfectants. Glutaraldehyde, hydrogen peroxide, ortho-phthalaldehyde, and peracetic acid with hydrogen peroxide are cleared by the Food and Drug Administration (FDA) and are dependable high-level disinfectants provided the factors influencing germicidal procedures are met. ..."
Review of the facility's Infection Control Plan, last revised March 2023, revealed "Overview and Purpose It is the goal of Lewisburg Plastic Surgery and Laser Center to provide a safe environment for the patients as well as the staff of the center. In committing ourselves to safeguarding individuals, Lewisburg Plastic Surgery and Laser Center Staff must fully understand the processes and systems that are utilized by the center to deliver quality patient care while minimizing the risk of Health Care-associated infections and the transmission of such. ... The purpose of the infection control plan is to provide a framework for the infection control program within the center. ... Authority and Responsibility Board of Directors The overall authority for the direction of the infection control programs rests with Lewisburg Plastic Surgery and Laser Center's board of directors. The board of directors delegates its authority to implement and maintain the infection control plan to the president and chief executive officer of Lewisburg Plastic Surgery and Laser Center. President and Chief Executive Officer The president and chief executive officer, in collaboration with administrative, managerial, and clinical staff, ensures that the patient safety improvement and management program is implemented throughout the organization and integrated appropriately with other activities within the organization which contribute to the maintenance and improvement of patient safety, such as performance improvement, environmental safety, and risk management. The president and chief executive officer will designate a qualified individual in the organization to manage the organization-wide patient safety improvement and management program at Lewisburg Plastic Surgery and Laser Center. Management Staff Lewisburg Plastic Surgery and Laser Center managers will ensure that the infection control program will be given high priority and will support the program. Managers will: ... 7. Ensure safe practice by all staff through observation and use of other appropriate evaluative processes. Infection Control Nurse: ... 2. Oversees the infection control polices" [sic] "and procedures as developed by the infection control committee/board of directors to ensure compliance with law, regulation, and accreditation standards... "
Review of the facility policies on February 20, 2024, contained no currently approved policies on high-level disinfection.
Tour and observation of the facility with EMP2 on February 20, 2024, at 1150 revealed a closed-lidded container in the dirty equipment room that contained liquid.
Interview with EMP2 at the time of tour confirmed the closed-lidded container was filled with Sklar Soak disinfectant for reusable laryngoscope blades that could not be autoclaved. EMP2 indicated that the disinfectant was changed out every other day and there were no logs maintained and no testing of the disinfectant's strength.
A request was made on February 20, 2024, at 1215 to EMP2 for the Sklar Soak manufacturer's instructions.
Review on February 20, 2024, at 1230 of the "Sklar Soak Directions for Use ... For Hospital/Medical/Surgical Use ... This product is not to be used as a terminal sterilant or high-level disinfectant on any surface or instrument that (1) is introduced directly into the human body, ... or (2) contacts intact mucous membranes, but which does not ordinarily penetrate the blood barrier or otherwise enter sterile areas of the body. This product may be used to pre-clean critical and semi-critical medical devices prior to sterilization or high-level disinfection. ..."
Interview with EMP2 on February 20, 2024, at approximately 1245 revealed they were unaware the Sklar Soak disinfectant was not to be used as a high-level disinfectant.
| | Plan of Correction - To be completed: 04/15/2024
1.The Infection Control Nurse Job Description has been revised to include:
- "Works with the Clinical Manager and the Medical Director to implement or change polices and/or products in regards to infection Control"
- The current Infection Control Nurse signed the updated Infection Control Job description.
2. A high level disinfection policy has been created effective on 2/20/24.
- On 2/20/24 The center has acquired a jug of High Level Disinfectant from Evangelical Community Hospital until the center receives the ordered supply of high level disinfection.
- On 2/20/24 The center has acquired a bottle of test strips from Evangelical Community Hospital until the center receives the order supply of high level disinfection test strips.
- All laryngoscopes were immediately disinfected on 2/20/24 to assure that all are ready for patient use.
- Operating Room Personnel responsible for the cleaning, disinfectant and sterilization of instruments received instruction on the proper techniques and protocol regarding high level disinfectant use for the disinfection of laryngoscopes. This education will be provided prior to the start of their next shift.
- Disposable laryngoscope blades are available in the center should there ever be a problem with the high level disinfectant process.
Monitoring: Implemented on 2/20/24. The infection control nurse or clinical manager will monitor the log on a weekly basis to assure proper protocols are being followed. The Infection Control Nurse will review the findings and provide a report to the infection control meeting at the quarterly meeting. If after 6 months the center is found to be in compliance, monitoring will be transferred to an ongoing Quality Assurance study.
3.Steam Sterilizable Laryngoscope Blades
- The Center has purchased steam sterilizable laryngoscope blades. The Infection Control Nurse worked with the Clinical Manager and the Medical Director in choosing the blades for the center. The following process will be in place prior to placing the blades in service at the Center.
- All staff responsible for the proper cleaning, disinfecting and sterilization of instruments will receive education on the proper protocols to follow based on manufacture instructions.
- Clinical staff who utilize laryngoscope blades will be educated on the proper care and use of the new steam sterilizable laryngoscope blades. This includes all CRNA's and surgeons.
- The DOH, DAAC will be notified of the plans to add steam sterilizable laryngoscope blades.
- The Infection Control Committee will review the information and if approved will make recommendation to implement the use of the steam sterilizable laryngoscope blades.
- The Board of Directors will then make a determination as to whether they will approve the implantation of the steam sterilizable laryngoscope blades.
- If/When the Infection Control Committee and the Board of Directors approve the use of steam sterilizable laryngoscope blades, the DOH, DAAC will be contacted with documentation of the education and the approvals from the Infection Control Committee as well as the Board of Directors to schedule an occupancy survey.
- Once the occupancy survey is complete, if approved the steam sterilizable laryngoscope blades will be put into service at the center. The current laryngoscope blades will be disposed of and the high level disinfection protocol will be discontinued.
- Disposable laryngoscope blades are available in the center should there ever be a problem with the steam sterilization process.
Monitoring:
The infection control nurse or clinical manager will monitor the steam autoclave logs weekly and will do a visual inspection of the steam sterilized laryngoscope blades to assure that proper protocols are being followed for the duration of the 6 month monitoring process. The Infection control nurse will evaluate the findings and prepare a report to the Infection Control Committee. If at the end of the monitoring period the center is found to be compliant, weekly monitoring will be discontinued and monitoring will be completed via an ongoing Quality Improvement Study.
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