|
|
|
| | Printer Friendly Version | |
 |
| |
| |
By Nancy Chobin, RN, AAS, ASCP, CSPDM
Corporate Consultant/Educator, Saint Barnabas Health Care System, West Orange, NJ.
NOTE: Nancy serves on the AAMI Sterilization Standards Committee and the AORN Recommended Practices Committee. She was the primary author of the AORN Recommended Practice on Sterilization (2006).
Flash sterilization was designed to immediately sterilize a one-of-a-kind device that was dropped or contaminated in the Operating Room. However, flash sterilization today is more often used to sterilize instruments needed for a to-follow base because of insufficient instrument inventories. This is especially true for Orthopedics and Ophthalmology cases.
How did we get to this practice and what can Sterile Processing do to help?
First, let us examine the practice of flash sterilization. According to AORN’s Recommended Practice on Sterilization, “Flash sterilization should be used only in selected clinical situations and in a controlled manner. Use of flash sterilization should be kept to minimum.”1
The reasons flash sterilization should be kept to a minimum is because of the many factors that can adversely affect the process. These factors include confine and contain the device in transport, proper cleaning, proper sterilization and containment of the device to the point of use. AORN further states:
“Flash sterilization should be considered only if all of the following conditions are met:
• The device manufacturer’s written instructions are available and followed.
• Items are disassembled and thoroughly cleaned with detergent and water to remove soil, blood, body fats, and other substances.
• Lumens are flushed with the cleaning solution and rinsed thoroughly.
• Items are placed in a sterilization container or tray in a manner that allows steam to contact all instrument parts.
• Measures are taken to prevent contamination during transfer to the sterile field.
• Documentation of cycle information and monitoring results is maintained to provide for tracking of the flashed item(s) to the individual patient.2
Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method. Flash sterilization should not be used as a substitute for insufficient instrument inventory.”3
Let’s look at these issues. First, the Sterile Processing Department (SPD) Manager is responsible for all of the cleaning, disinfection and sterilization activities performed anywhere in the facility. Therefore, the SPD Manager needs to play an active part in the sterilization processes performed in the OR. This includes:
1. Review the Flash Sterilization policy to ensure compliance with recommended practices and standards (AORN, AAMI).
2. Provide technical and educational assistance to the OR staff on the type of sterilizers being used, how to monitor them, etc.
3. Problem solve issues with sterilizers (inadequate color change of chemical indicators, positive biological indicators).
4. Monitor the processes to assess process improvement projects.
5. Facilitate the evaluation of new sterilization monitoring products.
6. Ensure the OR has the facilities and equipment to safely and effectively perform cleaning and flash sterilization.
If the OR cannot adequately clean the device, how can it be sterilized? Does the OR have written instructions from the device manufacturer specifying how to clean and sterilize the device? Without this information, the facility will bear full responsibility for the safety and efficacy of the device. Did the device manufacturer recommend a specific detergent or type of cleaning equipment (e.g. sonic irrigator?). If the OR does not have this equipment or detergent the cleaning will be negatively impacted. It might be necessary to send items to SPD for cleaning prior to flash sterilization. However, this could also create problems since the item is needed immediately.
It is important to note that flash sterilization may be associated with increased risk of infection to patients because of pressure on personnel to eliminate one or more steps in the cleaning and sterilization process. It is essential that all steps in the sterilization process be performed in a conscientious manner. Before sterilization, instruments should be thoroughly cleaned and dried in a manner consistent with AORN’s “Recommended practices for cleaning and caring for surgical instruments and powered equipment”4 and AAMI’s standards for decontamination, steam, and EO sterilization.5 Proper decontamination is essential in removing bioburden and preparing an item for sterilization by any method. Cleaning is the first step in decontamination. To remove debris from all parts of the instrument, the instrument should be disassembled (if possible) before cleaning. Failures in instrument cleaning have resulted in transmission of infectious agents.
One method for identifying issues with flash sterilization is process improvement monitoring. The SPD Manager should be reviewing the flash sterilization records on a monthly basis to identify issues with compliance. Any issues with non-compliance should be documented and resolved.
The use of a Flash Log is recommended and should specify the reason for flash sterilization. This form can be used as justification for purchases of additional instruments and will prioritize those purchases.
Sometimes scheduling issues impact on flash sterilization (e.g. (4) T&A cases scheduled for 7:30 AM but only three sets are available for use). These issues should be addressed with the OR. Sometimes the issue is with loaner instruments that arrive too close in time to the scheduled case. A policy on loaner instruments should be developed6 which clearly defines the amount of time required for cleaning, sterilization and cooling of instruments for your facility. This policy should be shared with the various vendors and their compliance monitored.
Selecting Cycles
Selecting cycles can be confusing to practitioners. There is confusion between a flash sterilizer and a pre-vacuum sterilizer. In actuality, both are flash sterilizers. The pre-vacuum flash sterilizer uses a mechanical means to remove air from the chamber and the “flash” sterilizer is actually a gravity displacement flash sterilizer. Gravity displacement flash sterilizers require a longer exposure time for lumened or porous items. If the flash sterilizer is a pre-vacuum type, then a dynamic air removal test (formerly called a Bowie-Dick test) must be performed daily to verify the efficacy of the air removal process. The pre-vacuum flash sterilizer can also be used as a gravity flash sterilizer. Therefore, biological monitoring of both cycles needs to be performed. If rigid flash containers are used for flash sterilization, then a biological test should be performed inside the container.
Some device manufacturers have extended sterilization cycles so it is important for the OR to have manufacturer’s instructions readily available. It is also important to change the sterilizer parameters back to the default setting after running a special cycle. It has been identified that some manufacturers no longer provide flash sterilization instructions. In this case, if the facility decides to flash sterilize the device anyway, they will assume all responsibility for the device.
Monitoring the Cycles
A good quality class V chemical integrator should be used in each flash cycle. A Class V integrator provides immediate information about all parameters for the cycle. The sterilizer chart or printout should be reviewed at the completion of the flash cycle and if all parameters met, signed by the sterilizer operator. Printouts and flash sterilization logs should be retained for the length of time specified by the facility’s legal advisor.
All biological testing should be documented. The frequency of BI testing is up to the facility and should be based upon the volume of flash sterilization being performed. At a minimum, AAMI recommends weekly BI testing but preferably daily and with all loads containing implantable devices. While AORN and AAMI do not recommend flash sterilization of implants, sometimes emergencies occur and an implant must be flash sterilized. It is important to monitor the BI and report any variances to Infection Control immediately.
Conclusion
Flash sterilization can be effectively performed if all recommended practices are followed. However, since items requiring flash sterilization are needed “immediately” it is usually the cleaning process that suffers. This can have a negative impact on the sterilization process. It is important for the OR, Infection Control, Risk Management, Process Improvement and SPD to work together to develop and implement flash practices that will provide safe and effective devices for patient care.
References:
1. Association of peri-Operative Registered Nurses. Recommended Practices for Sterilization. 2006.
2. Ibid.
3. Ibid.
4. Association of peri-Operative Registered Nurses. Recommended Practices for Cleaning and Caring for Surgical Instruments and Powered Equipment”. 2002.
5. Association for the Advancement of Medical Instrumentation. Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-46. 2002. Flash Sterilization-Steam Sterilization of Patient Care Items for Immediate Use. ST-37. 1996. Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Non-Clinical Settings. ST-35, 2002.
6. American Society for Healthcare Central Service Professionals and the International Association for Healthcare Central Service Materials Management’s Joint Paper on Loaner Instruments.
|
| |
 |
| |
| |
Reprinted with permission from May 2006, Healthcare Purchasing News.
Sterile processing professionals that have historically fought for respect, or even a simple pat on the back, may just find their place in the sun — if they are committed to taking the performance improvement plunge, that is.
Infusing day-to-day tasks with higher quality standards isn’t exactly a new concept in healthcare. Revenue-generating departments, such as the operating room, have been doing it for years in an attempt to improve patient care and further drive efficiencies and higher profits. Interestingly, though, non-revenue-generating functions like sterile processing and environmental services have historically been excluded from organizations’ performance improvement roadmaps, even though such quality efforts could significantly improve customer service and overall operating efficiencies, as well as maximize departmental resources and reduce the likelihood of instrument- or equipment-related complications.
"Many sterile processing departments aren’t doing any type of focused performance improvement, even though they and the facilities they serve would greatly benefit from it," said CS consultant Fred Wykoff of Salisbury, MD. He added that part of the problem is that some CS departments just don’t know where to begin. "All it takes is an understanding of what performance improvement really is, and an ongoing commitment to [the cause]."
Failing to develop a performance improvement process in CS can prove perilous for hospitals. As Mike Duckett, director of Stategic Initiatives for STERIS Corp., Mentor, OH, put it, "The goal of any business — and healthcare is a business — is to be profitable. To be profitable, you have to look at both the revenue-producing areas and the cost centers simultaneously." He noted that adding more surgical procedures to a facility that has an already saturated or non-productive sterile processing department will most likely result in a lower return than expected for the hospital. The result, he said, could create additional hardship on the SPD that could prompt higher staff turnover, increased quality problems and, ultimately, a frustrated O.R. team.
Although widespread adoption of performance improvement efforts in CS may be slow coming, more SPDs do appear to be getting the message – a move that can be at least partially attributed to performance improvement standards set forth by the Joint Commission on Accreditation of Healthcare Organizations. JCAHO’s goal is to ensure the processes are well planned and designed, that they are systematically measured and assessed, and that the improvements are implemented.
Laying the foundation
Performance improvement goes by many names, but whether facilities call it continuous quality improvement or total quality management, or another label, sources agreed that the terms are typically geared toward the same goal: improving processes to drive quality.
"People tend to get caught up in semantics, but the point is there are many variations on the theme and it makes no real difference what name is used. It all boils down to how an organization can move their energies to improve various processes, and ultimately, outcomes," explained John Whittlesey, principal of the Healthcare Management Council Inc., a Needham, MA-based healthcare benchmark-ing firm. "It’s about getting the engagement of staff and building a consensus so the department can move forward in a positive way."
STERIS’ Duckett cites the following as core components of an effective performance improvement process: a cross-functional team of all stakeholders or customers that serve or are served by the SPD; access to data, such as surgical procedure volumes, and the ability to translate this data in workload requirements; a process map to detail out potential bottlenecks and areas of waste; and the ability to translate data and process information into a technical, clinical and financial plan to allow the SPD to implement the necessary corrective actions.
When it comes to the various functions of sterile processing, it’s understandable how committing to solid performance improvement efforts can pay big dividends, both for the department itself and the hospital as a whole. After all, there’s no arguing that any efforts aimed at improving quality in decontamination and sterilization, instrument sorting, inspection, set assembly, and distribution, among other functions, is time well spent. At the same time, it’s understandable how embarking on such a performance improvement initiative can seem daunting to those who are new to the concept. Because of that challenge, SPDs would be better served by approaching the process methodically, yet specifically, and focusing on specific functions, sources told Healthcare Purchasing News.
"Breaking the process into more digestible pieces is important because if you don’t, it can be easy to become overwhelmed. Again, performance improvement is about progressively moving in the right direction, not about trying to overhaul everything at once," stressed Whittlesey.
To determine which areas to target first, sources agreed that SPDs should conduct a thorough audit of the department’s core functions. Sources agreed that these should, in the very least, cover decontamination, preparation and assembly, sterilization, storage and distribution.
When Wykoff consults a facility, he uses a more detailed form to determine if processes are being followed correctly. For the decontamination process, he addresses proper set-up and use of personal protective equipment, whether instruments were cleaned properly (and according to manufacturer instructions) and placed in the basket correctly. He then thoroughly addresses each step of the sterilization process. His checklist covers whether the rack or cart was loaded properly, whether the contents on the cart were properly documented, and whether the biological indicator was in place and checked and recorded at the end of the cycle. Wykoff also scrutinizes various aspects of O.R. trays, including whether they were correctly labeled, whether instrument wrappers were free of holes and tears, whether instruments were properly cleaned and assembled, and whether missing or damaged instruments were identified.
Whittlesey adds that mapping out hours of operation, staffing, individual cycle times and turnaround time, and then benchmarking that data against similar facilities, may also help SPDs pinpoint areas in need of improvement. "Having all that information at your fingertips allows you to ask the critical questions, ‘What are we doing?’ versus ‘What should we be doing?’"
Documenting trends
Depending on the situation or outcome, both a proactive and reactive approach to performance improvement may be in order. When the O.R. complains about a specific situation, such as a missing instrument in a set, for example, that will require a reactive response to remedy the situation quickly. But a good performance improvement strategy "also requires a proactive approach where SPDs work to make sure that same problem doesn’t keep occurring," said Wykoff. "That’s how quality is improved in the long-term."
Moving from a purely reactive approach to a more proactive one requires effective, consistent documentation. Unfortunately, that’s one step that many SPDs tend to overlook, according to Richard Schule, director of clinical sterile processes for Clarian Health Partners, Indianapolis.
"Many times, [SPD staff] may think they’re listening to their customers, but if they’re not adequately documenting or surveying their customers – and then using that information to their best advantage – they can’t expect to effectively track trends and identify problem areas," he noted.
Another reason to continuously monitor and document? According to Wykoff, some CS customers, particularly the O.R., may become so frustrated with ongoing instrumentation problems that they eventually stop complaining. "This can lead to a false sense of security that everything is fine, even when many problems exist. It’s critical to work with customers and follow-up with them to stay on top of any issues and resolve them as quickly as possible."
In its own customer surveys, STERIS found that the O.R. is looking for three basic things from the SPD: clean and sterile instruments, complete instrument trays and on-time delivery. "By establishing mutual expectations for these three deliverables, in number goals, the SPD manager can recalibrate their workflow and prioritize their efforts to meet the daily requirements of the O.R.," explained Duckett.
Still, Schule acknowledged that it can sometimes be difficult for departments to assess their own processes and shortcomings. He recommended forming a network with other facilities, and even other industries, to foster new ideas on how to improve quality.
"A fresh set of eyes can be very helpful," he said, adding that local chapters of quality improvement groups, such as the American Society of Quality, can offer a wealth of information. "Basic quality improvement concepts are the same, regardless of the industry [in which] they’re applied."
The ASQ cites the four-step Plan-Do-Check-Act Cycle as one of the most widely used tools for continuous improvement. Put simply, the cycle revolves around identifying an opportunity and plan for change; implementing the change on a small scale; using data to analyze the results of the change and determining whether it has made a difference; and implementing the change on a wider scale, if it was successful.
Participation in JCAHO’s performance improvement goals can also help. Through case study presentations and panel discussions, participants will have the opportunity to assess their organization’s compliance with the performance improvement standards and compare their facility’s activities with those of the featured case study organizations.
Partnering with a consultant is another option, and may be the right choice for SPDs with management vacancies and high staff turnover, Duckett pointed out.
"Using an outside resource to act as a catalyst for change [can be highly effective]," he said. "Healthcare customers need consultants who will roll up their sleeves and actively lead the improvement process rather than merely provide ‘white paper’ information." SterilTek Professional Services, a subsidiary of STERIS, was developed to help SPD customers meet the expectations of each department they serve within the hospital. Specifically, the team is driven to help customers achieve the ultimate sterile processing goal of "100 percent clean and sterile, 100 percent complete and 100 percent on-time."
Testing the system
Like any implemented process, performance improvement strategies must be tested to determine their effectiveness – and whether additional adjustments are in order.
To improve the quality of instrument trays, each CS supervisor at Bronx, NY-based Jacobi Medical Center opens up ten random sterilized trays per day (except weekends) to closely examine their assembly and contents. The supervisors pay close attention to the way the instruments were wrapped and whether the instruments were properly cleaned and assembled, for example. The facility carefully documents the findings to pinpoint trends.
"We keep records for two to three years, so we have adequate data to work from," said Don Gordon, CS network director for Jacobi Medical Center. The process has helped Jacobi’s SPD identify various areas in need of improvement, including wet packs, which were able to be quickly remedied by the use of tray liners and extended drying times.
When Wykoff consults SPDs in the area of performance improvement, he also encourages managers and supervisors to perform random set checks. "I recommend pulling two random sets from each employee each week, so they can get a clearer picture of what’s going on, and what additional training may be required," he said, adding that such checks also allow supervisors to give credit for a job well done.
Innovative products and solutions can also boost SPDs’ performance improvement efforts by targeting some of the perennial problems plaguing the department. In March, Verimetrix LLC, St. Louis, MO, introduced Veriscan, the first automated endoscope leak testing technology. Veriscan is said to provide a precise, repeatable and documented process that reduces total repair costs by roughly 50%, while also reducing cross-patient infection risk. Veriscan also has the ability to automatically record each leak test and retrieve it on command via the LCD display, printing or downloading to a computer, allowing facilities to analyze scope damage, track procedure activity and ensure every endoscope is properly leak tested.
"Scope damage is common. Unfortunately, scopes are difficult to leak test. Entry level staff perform the task, turnover is high and short staffing leads to rushing," noted Pat Holland, R.N., former president of the Society of Gastroenterology Nurses and Associates. She added that undetected leaks are frequent, and can lead to annual repair costs of $100,000 or more at many institutions. Catching a faulty endoscope early can mean the difference between a repair of as little as $200 versus a repair of $8000 or more, Verimetrix reports. Veriscan product trials at Duke University Hospital, Barnes Jewish Hospital, the Sisters of St. Mary’s Healthcare System, and others, revealed a reduction in endoscope repair costs by as much as 70 percent.
If used to their fullest potential, automated instrument tracking solutions can also boost performance improvement efforts by providing SPDs with a broad range of meaningful and easily accessible data. Today’s instrument tracking systems are more sophisticated, allowing users to pinpoint and categorize a list of problems, and run detailed reports that can be broken down by specific function, cycle, employee and shift.
No end in sight
When embarking upon a performance improvement initiative, sources agreed that SPDs must be willing to settle in for a long journey. That’s because no matter which tools and protocols are used, and the level of staff commitment and buy-in, the performance improvement process never draws to a close.
In fact, committing to performance improvement can be a bit like opening Pandora’s Box.
"Some people may wonder, ‘Where does it end?’ The short answer is quality doesn’t end," said Schule. "You may see the light at the end of the tunnel, but you’ll never be fully there. When one improvement is made, you move onto the next, and you never stop checking that the changes that were made are still working. That’s what makes performance improvement so [beneficial]. It’s an ongoing process with a long-term vision."
Reprinted with permission from May 2006, Healthcare Purchasing News.
|
| |
|
| |
|
