By Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
Q: In reviewing our manual high-level disinfection (HLD) records, I noted that on several occasions, the temperature of the solution did not reach the manufacturer’s recommended temperature. The technician did not notify the supervisor of this problem and the following technicians never noted this error on the log. What should we do?
A: This is a serious problem which can have patient safety implications. First, you should report this to your risk management and infection prevention departments. They will take the appropriate administrative action needed.
According to ANSI/AAMI ST-58, Chemical sterilization and high-level disinfection in healthcare facilities (2013, Section 126.96.36.199 Process parameters), “Typically, after being thoroughly cleaned, an item is immersed in the LCS/HLD for a defined period of time at a set temperature; these parameters are determined by the manufacturer and indicated within the manufacturer's written instructions for use (IFU). Some products are intended for manual use in trays or other containers; it is necessary for the user to ensure that the sterilant concentration, exposure time, and exposure temperature are correct and to manually rinse the sterilized or high-level disinfected items using aseptic technique. Healthcare personnel should follow the HLD product manufacturer’s instructions for use.”
This appears to be an education issue. Anyone performing high-level disinfection should receive both an initial orientation and on-the-job training. Competency should be assessed for all employees performing these activities upon orientation, whenever products or processes are changed, and at least annually thereafter. A day-to-day orientation program is recommended and should be designed to lead to competency-based knowledge and skills …for chemical high-level disinfection. Staff should not be permitted to be in the area where HLDs are being used unless they have received specific training in their use.
It is important to ensure staff has not only received the training but competency verification has been performed initially and annually. Many HLD manufacturers have competency assessment forms that you can use, reference charts which can be posted as a reminder for the staff and even videos.
There should be a detailed policy and procedure for use of the HLD including necessary PPE recommended, use of the HLD, the recommended MEC testing protocol, rinsing recommendations, etc. Make sure that staff members are familiar with the policy. This policy should be posted in the HLD area as a reference as well. The policy should also address what action to take if the recommended temperature is not achieved. The manufacturer of the HLD should be consulted when the HLD is being purchased, how to heat up the solution if the temperature cannot be achieved in the area where the HLD is going to be performed.
All items processed in HLD should be documented. The form should contain the following information:
Date of the HLD
- Lot number of the HLD
- Shelf life date of the HLD (from the container)
- Date the HLD container was opened/activated
- The department (if applicable) and specific item(s) processed in each HLD soak
- The temperature of the solution (if specified by the HLD manufacturer)
- The results of the minimum effectiveness (MEC) testing of the solution before each use
- The time the item(s) were placed in the solution
- The time the items were removed from the HLD solution
- The total soak time
- The name of the person who performed the HLD
- The action taken if the MEC level was below the recommendations
If the staff member was knowledgeable in the required minimum temperature (i.e. was this posted in the area as a reminder? Printed on the HLD form?). Not reporting any problem with the HLD process was inexcusable. Staff should feel comfortable to report any non-compliance with a policy. Not reporting such an incident is sometimes worse than reporting it! Re-training should be performed and the person responsible should not be permitted to perform HLD until another competency assessment is made and the person passes.
I recommend that your department perform daily audits of the HLD records. Documentation is a critical form of any process. Since this was a serious error, I would recommend auditing the HLD process each shift until it has been shown that staff is complying with all policies and procedures and IFUs. Thereafter, I recommend a daily audit be performed (i.e. review of the previous day’s HLD documentation) to ensure that all of the documentation has been recorded and to ensure continued compliance.
The media and the Internet are continuously reporting instances of processing failures and its impact on patients. We have a duty and obligation of the patient to ensure the devices we process are safe to use when needed. This means they have been collected, cleaned, prepared, HLD and stored and distributed according to recommended standards. It is also important to remember that most sterile processing personnel learn on-the-job, therefore their training is critical. We should ensure staff receives the training they require to keep our patients safe.
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is a sterile processing consultant and educator.