By Kelly M. Pyrek
In a Quick Safety message to its accredited facilities in May, the Joint Commission (JC) alerted healthcare organizations regarding surveyor observations of increased non-compliance with standard IC.02.02.01, which requires accredited facilities to reduce the risk of infections associated with medical equipment, devices and supplies. Last year, according to the Joint Commission, this aforementioned standard was one of the top five non-compliant requirements for JC-accredited hospitals, critical-access hospitals, and ambulatory and office-based surgery facilities.
The 2013 noncompliance rate by program was:
- Hospital (46 percent)
- Critical-access hospital (47 percent)
- Ambulatory care (38 percent)
- Office-based surgery (29 percent)
Even more alarming is the fact that of 13 immediate threat to life (ITL) discoveries from surveys conducted in 2013, seven were directly related to improperly sterilized or high-level disinfected equipment, according to the Joint Commission. If an ITL is discovered on survey, the healthcare organization immediately receives a preliminary denial of accreditation (PDA) and, within 72 hours, must either entirely eliminate the ITL or implement emergency interventions to abate the risk to patients (with a maximum of 23 days to totally eliminate the ITL). Corrective actions may include: reprocessing of all equipment or instruments involved in the infection control breach; evaluating staff competency and conducting training; and implementing an equipment tracking process that traces items used back to the patient, in the event of an infection control breach or recall.
"This alert should have sent a shock wave throughout healthcare facilities," says Susan Klacik, CSS manager at Humility of Mary Health Partners and AAMI representative at IAHCSMM. "I wish I knew how many infection preventionists saw this alert and went straight to their hospital's central sterile (CS) department and said, 'Whoa, what's going on?'" she says. "I really think what we need is to have mandated certification of central sterile techs because right now some people don't know what they don't know. But once you are certified, you do know."
Klacik continues, "When you read through that Joint Commission communication, much of it can be ascribed to lack of education. In CS, we are trained how to do things the right way and I truly believe that the errors that were made were not intentional, but due to a lack of education and training. What really stood out to me was that in 2013, 13 of the immediate threat to life incidents were due to disinfection and sterilization, and that's a huge problem. When you look at a hospital environment and all of the things that could potentially harm a patient, 7 of 13 citations were due to disinfection and sterilization failures -- that is why education is critically important."
Currently, just two states -- New York and New Jersey -- mandate through state law the certification of sterile processing personnel, although Klacik points out that Association for the Advancement of Medical Instrumentation (AAMI) ST 58 allows healthcare facilities to require techs to be certified. She says there's significant room for improvement when it comes to ensuring that sterile processing and central sterile workers fully understand the proper processes involved in medical instrument and device reprocessing.
This issue is addressed by AAMI in No. 9 on its list of "10 Things Your Organization Can Do Now to Improve Reprocessing":
1. The basics: Cleaning and disinfection/sterilization of reusable devices are separate, equally important processes and must be performed before each patient use according to the device manufacturer’s written instructions for use (IFU). For more information go to: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm.
2. The right tools: Have the IFU as well as all cleaning implements and equipment required by the IFU readily available in all the reprocessing areas.
3. Create a multidisciplinary committee to review the priority issues and set a plan for solving them throughout the organization. The following areas should be represented: OR, infection prevention and control, healthcare technology management (biomed), endoscopy, risk management, quality, safety, education, and materials management.
4. Share lessons learned: Remind senior management and safety officers that it costs a lot less to “do it right the first time.” Share lessons learned from other healthcare organizations that have had to inform patients of exposure to inadequately reprocessed reusable devices.
5. Written procedures: Establish a formal program for reprocessing, including written standardized policies and procedures that include a chain of accountability. Expert guidance can be obtained from industry experts in order to resolve conflicts between the IFU and facility policies. Written procedures should also be developed and implemented for central sterile processing reporting of inadequate instructions, equipment problems, and in-service issues to the manufacturer and, when applicable, to the FDA’s MedWatch program.
6. Standards matter: Know the current standards, recommended practices, and IFU.
7. Purchasing: Central sterile processing should be included in purchasing decisions for medical devices, to provide input on whether the device can be reprocessed appropriately and with the facility’s existing resources.
8. Separate and standardize functions and locations: Separate central service (warehouse, stocking, etc.) from reprocessing; create standardized job descriptions and functions.
9. Training: Train, train, and retrain. Ideas include: assess staff competencies; negotiate for training budget with cost/benefit analysis to prove value; partner with vendors for education; create a list of available continuing education units (CEUs) for easy access by staff; work with human resources to create career ladders for certification and promotion; promote the importance of certification. Note: In-service for loaner or new instruments should include reprocessing in-service areas that are separate from (or in) central sterile processing.
10. Assessment: Conduct an audit of compliance with standards and regulations, using any number of available tools and resources. Go to: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/ucm252941.htm.
According to the Joint Commission communication, "Breaches in equipment sterilization and high-level disinfection processes can result in outbreaks of HIV, and hepatitis B and C, as well as the transmission of bacterial infecting agents, such as Pseudomonas aeruginosa, E. coli, MRSA (methicillin-resistant Staphylococcus aureaus), salmonella, and Clostridium sordellii. In many instances, the problem is long-standing, and the true scope of the problem isn’t known until there is an outbreak or the CDC is called in because the contamination is out of control. Facilities that undergo an outbreak or shut-down also have repercussions from bad publicity and loss of business, not to mention damage to the organization’s reputation. A typical case scenario (aggregated from the reports to the Joint Commission’s Office of Quality Monitoring) follows: A process failure occurred in the processing of endoscopes. Specifically, the soaking cycle required a soaking cycle of 20 minutes; the programmed cycle was 5 minutes. A number of patients were at risk for infection, including lung transplant, HIV, oncology and cystic fibrosis patients. The organization had no mechanism in place to track equipment use by patient."
"Breaches come down to people not knowing what they don't know," Klacik emphasizes. "For example, techs knew to disinfect the scope but they didn't know they had to get specific instructions as to how to use the high-level disinfectant properly. There are so many steps involved with using a high-level disinfectant that people just weren't aware of them. But if you have certified techs, they know these critical steps. It stood out to me from this alert that if these people were CRCSTs, these ITLs wouldn't have happened. These techs would have waved the flag and said 'Wait, we have a problem here.' And that's why it says in AAMI ST58 and ST 79 that you have to be certified."
Klacik adds, "It's also about not following the manufacturers' instructions for use (IFU). People need to refer to the IFUs if they have any questions. They need to read those thoroughly, as everything they need is right there. My facility also refers to oneSOURCE, which is a great online tool for accessing manufacturers' IFUs in one place. Techs may be working at their tables and perhaps they are unfamiliar with a particular instrument; they can go on the oneSource website and find it 24/7."
According to reports to the Joint Commission’s Office of Quality Monitoring, findings from non-complying organizations include:
- The mistaken belief that the risk of passing bloodborne pathogens or bacterial agents to patients is low
- Staff lack the knowledge or training required to properly sterilize or high-level disinfect equipment
- Staff don’t have access to or lack knowledge of evidence-based guidelines
- Lack of leadership support
- Frequent leadership and staff turnover makes sterilization or high-level disinfection of equipment a low priority
- Lack of a culture of safety that supports the reporting of safety risks
- Processes for sterilization or high-level disinfection are not followed (i.e., staff take short-cuts)
- The time frames for proper sterilization or high-level disinfection of equipment are not followed
- There is no dedicated staff person to oversee the proper sterilization or high-level disinfection of equipment
- Facility design or space issues prevent proper sterilization or high-level disinfection of equipment (e.g., processing takes place in a small room that is also used for storage)
- Lack of monitoring or documentation of sterilization or high-level disinfection of equipment, which makes it difficult to track the use of equipment on a specific patient, complicating the patient notification process when an outbreak occurs
- Equipment is spread throughout the facility and may be processed or stored in numerous locations, making it difficult to track the equipment for documentation purposes.
Klacik says it is imperative for facilities to partner with manufacturers to address knowledge gaps regarding proper reprocessing practices. "The good news is that I have seen a lot of manufacturers step up, some who are being proactive about calling me to say they have a new in-service for a product, can they come in and train our techs," Klacik says. "I really think the 2011 AAMI/FDA summit on reprocessing medical devices helped create more awareness, because some of the companies are developing competencies testing or other great training tools. I am happy to see this because when I talk to manufacturers I tell them we need to partner with them because our objectives are strategically aligned -- we both want that surgical instrument to function exactly as it was designed and intended to every time. So they need to come to the CS department, train the staff on how to properly process the instruments -- how to clean them, high-level disinfect or sterilize them, and check them -- because the next person who sees these instruments from us is the surgeon, and we want them to be perfect. We want the instruments to work perfectly for the surgeon every time because that goes to the heart of patient safety."
Klacik continues, "We also need to partner with manufacturers because their instruments are so complex these days that we need additional training in order to reprocess them correctly every time. Some of the manufacturers are getting on board with that. We still have a ways to go but it's nice to see it starting to happen. They are starting to hear us. But the next big thing is that we must mandate certification. If you want a high-quality process, you need a high-quality staff. They need to be confident in their abilities, and certification demonstrates competency."
Another key partnership is the one that takes place in the hospital between CS staff and the facility's infection preventionist and even C-suite leadership. "The issue of improperly disinfected and sterilized instruments and devices should be on their radar," Klacik says. "I don't know if they all see the importance of it, but I think the closer you are to the CS department, the more you respect and understand it and you see the need for education, training and resources. A lot of people are still not aware of what we do; I have had people tour our department and it's eye-opening for them. They ask, 'How do you know all of this?' because there is so much to pay attention to, and it's amazing what these techs have to know -- and not just the instruments themselves, but the cleaning and disinfection and sterilization. It's mind-boggling how complex it is. You need good, seasoned staff members who are well trained." Klacik adds, "I want to see infection preventionists come down to CS, and a lot of them do. They need to see first-hand what our needs are, because they have a lot of authority in the hospital; they are closer to the C-suite so they can get in there and be our champions for tech certification and the resources we need."
Safety actions to consider, as suggested by the Joint Commission, include:
- Make sure staff are competent and trained in sterilization or high-level disinfection of equipment
- Make manufacturer’s instructions for use (IFU) available to staff and ensure that the instructions are followed
- Use and follow evidence-based guidelines when sterilizing or high-level disinfecting equipment
- Ensure oversight of sterilization or high-level disinfection of equipment
- Follow your organization’s policies and procedures for sterilizing or high-level disinfecting of equipment
- Use a central location to sterilize or high-level disinfect equipment within the facility, when feasible
- American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI): Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012
- American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI): Chemical sterilization and high-level disinfection in health care facilities, ANSI/AAMI ST58:2013
- Centers for Disease Control and Prevention: CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
- Association of periOperative Registered Nurses: AORN 2013 Perioperative Standards and Recommended Practices for Sterilization
Joint Commission. Quick Safety: Improperly sterilized or high-level disinfected equipment. Issue 2, May 2014.
AAMI. 10 Things Your Organization Can Do Now to Improve Reprocessing. Accessible at: http://www.aami.org/publications/summits/2011_Reprocessing_Summit_publication.pdf