At the beginning of the year many of us made New Year’s resolutions to make changes, perhaps to get healthier, lose some weight or something to make life better. Whether at home or at work we try to take charge of the change that we need in order to accomplish the goals. We work very hard trying to reach those goal and sometimes feels like it might seem impossible, but we stay focus on the vision of getting slender or healthier. In sterile processing we face similar challenges except that the goals we set for our department may impact directly the outcome of a surgical procedure and a patients’ life. We must keep in mind patient safety, physician/staff satisfaction, cost, quality and outcomes. A lot to consider for a department that traditionally everything remained the same but everything around them has been rapidly changing. I remember when I first started as a central sterile technician and the most complex task we had to do was to sharpen the hypodermic needles tips on a sharpening stone to ensure the next patient had a pleasant experience. There were no robots in the OR and if you asked anyone about “IFU” they may have thought you were cursing them out. We have certainly evolved!!!
Todays’ Sterile Processing is a manufacturer of complex instrument trays used for complex surgical procedures. These instrument trays require a rigid process following elaborate instructions for cleaning and sterilization in order to make the trays ready for the surgeon. Regulations and guidelines have also changed. In the past no one knew what “sterile processing was,” today almost weekly we get an article that highlights sterilization breaches at some hospital. The Joint Commission accreditation has also a renewed focus on Sterile Processing and during surveys they will ensure the department is in compliance with the latest mandates. As direct overseers of the department you may get overwhelmed trying to understand and implementing these changes especially if you have not stay abreast of all of the changes and have obtained the latest AAMI ST79 standards. Implementing process improvement can be as simple as following the procedures for reprocessing an instrument tray or as complex as determining what do you need to do in order to pass an accreditation survey.
Deficiencies in high level disinfection and sterilization have been highlighted in many media reports, professional journals and regulatory agencies such as the FDA and the CDC. In the Quick Safety publication Issue 33 May 2017 entitled “Improperly sterilized or HLD equipment – a growing problem” the Joint Commission stated that during the period of ‘2013-2016, immediate threat to life (ITL) declarations directly related to improperly sterilized or HLD equipment increased significantly. In 2016, 74 percent of all ITLs were related to improperly sterilized or HLD equipment.” This is a significant statistical number when thinking about the number of surgical procedures performed in this country and how many patients are affected or potentially affected. Issues related to improperly cleaned, disinfected and sterilized instruments also made the ECRI Institute's 2018 Top 10 Patient Safety Concerns for Healthcare Organizations for the second year in a roll. Furthermore, the number of incidents at hospitals, dental clinics and ambulatory surgeries do not cease to make the front page of every journal on a regular basis. Can we get to the root cause of this continuous occurrences? Can these events be prevented? Absolutely!!! How can you prevent a sentinel event in your sterile processing department?
Following a simple 4 step program which we call PEER, (Preparation, Examination, Education and Reformation), can help your facility be in continuous readiness mode. Let’s explore each and every one of these elements to open the door to success in your department.
> Preparation – it is essential to be prepared and have knowledge of all of the evolving changes of the industry. Policies and procedures that adhere to regulatory standards must be developed in order to serve as guidance to staff performing these critical tasks. Risk prevention can only be achieved if sterile processing leaders and technicians are knowledgeable of all requirements and are continuously monitoring compliance. Every sterile processing department should be equipped with a library of resources and use it as the foundation for process improvement and risk prevention. Some of the resources but not limited to this list are:
> Regulatory Standards
• Local DoH
> Professional Standards:
• ANSI/AAMI Standards: ST79:2017; ST91:2015; ST90:2017; ST58:2013; & ST41:2008 (R2012)
• AORN standards
• SGNA Standards
> Accreditation Standards
• The Joint Commission
o High Level Disinfection (HLD) and Sterilization BoosterPak
> Examination – In order to reduce risk of infection as a result of breaches in the high level disinfection and sterilization processes, it is imperative to conduct a risk assessment. A comprehensive examination should cover all areas where reprocessing is done following a specific check list to determine the organization’s vulnerabilities. The Joint Commission’s High Level Disinfection (HLD) and Sterilization BoosterPak provides guidelines for the risk assessment. Healthcare organization can also engage a healthcare professional expert in reprocessing practice to conduct a comprehensive review of their reprocessing procedures.
> Education – Todays’ advances in surgical procedures require more complex instrument which in some cases is more difficult to disassemble, take longer to clean with different sterilization cycles. In order to efficiently reprocess these complex medical devices it is absolutely necessary to follow the device instructions for use (IFU) and the multiple important steps to render a microorganism free instrument to the surgeon. New technology that has been introduced into sterile processing also require specific knowledge to be able to operate it properly. Quality audits and accurate recordkeeping as well as process consistency is essential. The healthcare facility must have a robust initial and continuous educational program in order to ensure technicians are competent performing their job responsibilities. Training documentation must be maintained and updated as new products are added or processes are changed. Accrediting agencies will be rating competencies for front-line staff and those responsible for the oversight of the department. Education is an essential key to Preparation.
> Reformation – A comprehensive examination of the process will help you identify environmental, process and technical issues that would require to be changed to comply with the standards. It requires a collaborative effort to reform the process therefore participation of the leadership, operating room, infection control and sterile processing is crucial. Sterile processing must have adequate space, equipment, and resources in order to provide quality services, maintain a safe environment and reduce the potential risk of infections. SPD technicians and leaders must be equipped to ensure the process is laser focused on quality to eliminate the potential of process failure that may result in serious outcome for the organization.
In order to adhere to the new standards, become a center of excellence, and reduce risk potential sterile processing departments and their leaders must focus in creating processes that are consistent, and replicable. To accomplish excellent quality all processes must be reformed, technical expertise must excel and PEER collaboration for success must be developed. The ultimate goal for process improvement is not just to prepare for an accrediting survey but to ensure that every patient who comes through your facility have an excellent, safe and successful treatment.