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Sterile processing migrates towards electronic record-keeping
Increased accountability for sterility assurance indicators
by Jeannie Akridge

Ask any sterile processing department manager whoís had to chase an elusive paper trail after finding a positive biological indicator or in preparation for a JCAHO visit if they would like an electronic record keeping system, and youíre sure to get a resounding yes!

The SPD is centered around processes and procedures that must be followed precisely, and painstakingly documented and archived. Those documents speak volumes of the integrity of the entire department, and even the hospital.

"In a hospital or healthcare delivery environment, you canít see if something is sterile, nor can you test for something that is sterile. Because once you test for it, itís no longer sterile and canít be used," said Janet Prust, marketing manager for biological indicators, 3M Sterilization Assurance.

To monitor the sterilization process, the SPD uses a variety of indicators, from chemical to biological to external, and relies on its workers to use these tools correctly and perform their jobs up to standard.

"Sterility assurance is looking at all of those pieces of information, putting it together to have the best level of confidence that the item indeed is sterile," said Prust. "The last piece of that program is really the record-keeping aspect of it. Itís putting all of those pieces of information into a documentable format that can be used to be able to control those processes but also to be able to be maintained and accessed in the future if that sterilization process monitoring information is needed."

Clearly, the need for accurate, up-to-the-minute, easily accessible sterilization data is paramount. This can be achieved with traditional, paper-based records, however, as many facilities are discovering, electronic record keeping systems are much less time-consuming and provide sizeable benefits.

Changing climate

While professional standards such as those from the Association for the Advancement of Medical Instrumentation (AAMI) do not currently specify the use of electronic records, they are moving in that direction. AAMI first made a reference to electronic records in its ST46: 2002 standard, (Steam Sterilization and Sterility Assurance in Healthcare Settings), stating that both paper and electronic records meet their recommendations, explained Prust.

"Electronic records are actually preferable to paper record systems," said Prust. "And thatís for a variety of reasons: thereís data integrity, security, legibility. Electronic records are designed in a way to require people to enter the information before they can complete the process," she explained.

3Mís Record Keeping Software is a customizable solution that enables hospitals to enter instrument sets, equipment and parameters that need to be met to be able to release a load, plus set permission levels for staff access. It also allows tracking and productivity management reporting capabilities on both a facility and system-wide basis.

Certainly many hospitals still rely on labor-intensive, paper record-keeping systems, and when properly applied, they can be quite effective. But change is imminent for the SPD on many fronts.

"I think the majority of the hospitals are still using paper-based [systems]. But many of them are migrating into an electronic record keeping program because they see the benefits of that. The other big piece that contributes to that is hospital IT systems have made significant improvements in the last few years. If we were talking five years ago, not a lot of sterile processing departments had computers in them. Now nearly all of them have computers in areas beyond just the managerís office," said Prust. "Sterile processing departments really recognize, as we all do in both our personal lives and professional lives, the benefits of using IT technology to make our jobs easier."

According to Prust, IT support is key. "Facility IT departments are very capable of meeting the needs of the sterile processing department. But it is important that sterile processing be prioritized Ė first identified and then prioritized Ė when hospitals are setting out their IT expansion or improvement strategies."


Not only is electronic record keeping becoming more plausible as the preferred method of documenting the sterility assurance process, it may soon become a necessity moving forward.

"But the reality is in the U.S. thus far, itís often perceived as a luxury and not a necessity," explained Todd Nielsen, director of sales for infection control, Getinge USA. "In other words, hospitals with a choice between getting one more washer or one more sterilizer, and getting a software system, reluctantly choose to get the other washer or sterilizer because they must have those.

"Now, weíre seeing a shift in that because both JCAHO and AAMI are beginning to become much more definitive about the requirements that goods be traceable to the patient Ė that an SPD be able to trace where goods were or to make a near immediate recall of goods if they find that a BI goes bad," said Nielsen.

Prust agreed. "The standards are heading toward the direction of a requirement to have all items that are sterilized be able to be directly traced to the patient," she noted. "Right now itís not required except for items that are implantable devices. But itís clear that itís going to be headed that way in the future, and one of the reasons for that is because electronic programs such as a record keeping software provide a mechanism for the hospitals to do that. Electronic record keeping allows that tracing all the way to the patient. So by implementing that now, hospitals are really preparing for what will eventually be needed," she said.

Ultimately, suppliers contend, these sterilization records will be tied to each patientís electronic health record (EHR). "I think thatís the end-game, the Holy Grail," said Nielsen. "Where you can electronically sit down at any PC in the hospital and find a way in to determine which set of instruments was used on Mrs. Jonesí hip surgery last August. On paper thatís an arduous process at best, maybe impossible."

Regardless of the method, there will be obstacles to overcome in tying these records to patients. "The greatest challenge to complete sterilization record-keeping will be the requirements of HIPPA law," predicted Mike Duckett, vice president of operations, SterilTek Inc., a wholly owned subsidiary of STERIS Corp. "It will be challenging for hospitals to protect patient privacy while tying all sterilization data to each patient. Some facilities have assigned neutral reference numbers that can maintain the anonymity of the patient, but this requires additional steps to retrieve the information if it is needed, through an approved intermediary. The more complex process would require a strong commitment and investment of time, money and effort on the part of the hospital," said Duckett.

Systems that combine instrument tracking with sterility assurance record-keeping will prove especially valuable when tying instruments to patients. As with the 3M solution, most of these systems use bar code tracking technology.

TGX Medicalís Alex Gold system tracks instruments from the operating room through decontamination, set assembly and sterilization to storage, ensuring that they have been properly cleaned, assembled and maintained.

Getinge offers its T-DOC (Total Documentation) productivity management system that tracks the location of instrument sets, whoís handled them, what machines theyíve gone into, their sterility and disinfection status, as well as maintenance status, for example, whether the instrument is sharp or the batteries need changing, explained Nielsen. "The key hallmark that we have at Getinge is that we integrate the software to the equipment. The washer- disinfectors and the sterilizers speak in real-time to T-DOC and the database archives that information for future reference."

Mandatory reporting

Hand in hand with linking sterilized items to individual patients is the push by states to instate legislation mandating hospital reporting of infections. SPD record-keeping will play a key role in this area as well.

"Mandatory reporting simply means more scrutiny in all of the practices around reducing infection," said Prust. "Sterilization is considered a sentinel event around surgical site infections. So for a facility to be able to document and prove that they did all of those things the right way via an electronic record keeping system is a tremendous value for a facility."

By the same token, if a hospital has a high level of reported infections, inadequate record keeping can "cast suspicion on that sterile processing area relative to the effectiveness of their sterilization practice," Prust added.

Getingeís Nielsen explained that the European regulatory environment is such that software systems are becoming a necessity in the SPD. "The way we see that here in the U.S. is that theyíve had more Mad Cow incidences and more prion outbreaks. Itís those sorts of things unfortunately that get peopleís attention and cause change.

"Nosocomial infections donít ordinarily get traced back to SPD. But in reality, it may take one bad infection incident to change the whole environment, whether it be for training and resources that go to training, things like certification, or whether they go to investing in things like better record keeping systems or automation for those systems," Nielsen added.

Unannounced inspections

Yet another prime motivation for hospitals to implement an electronic record-keeping program in the SPD is that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is starting its unannounced inspections this month.

"The level of interest in our record-keeping software has quadrupled this year compared to where it was last year," said Prust. "A lot of that is driven from this recognition that hospitals need to be in a continuous state of compliance versus, Ďwe know the Joint Commission is coming in next June so therefore weíre going to start preparing for it in Marchí. They realize now, with the Joint Commission moving to unannounced audits in 2006, that they need to be compliant, and they need to be in a continuous state of compliance.

"And for sterile processing, one of the key things an accrediting organization will look at is the records. Their records are what they have to prove that theyíve done things the right way Ė the only information that they have to prove that theyíve done things the right way. Their policies and procedures prove an intent to do it a certain way, but the records prove that it was actually done," said Prust.

Getinge is helping facilities gain an advantage for unannounced inspections with its Verified Performance Program that centers around the SPDís washing processes. "One of the thought processes of why we developed the Getinge Verified Performance Program was so that folks would be ready for those unscheduled inspections," said Bob Hammond, director of consumable operations, Getinge USA.

"Based upon the AAMI standards that are in place today, the scale of measurement here after instruments are washed is visual inspection. I think most of us would agree that a method of visually inspecting the instrument is not a very good method," said Hammond.

"So we really wanted to offer some means for the customer to verify the performance of their washers. And that really starts out with a thorough survey of their current operations. We look at your product and processes, make recommendations for improvement, look at the chemicals that youíre using to wash your instruments and see if theyíre really doing the job."

Hammond explained that one of the ways in which Getinge verifies equipment performance is through a test from Healthmark Industries called TOSI. In addition, the Getinge Verified Performance Program can help hospitals to determine whether they are over-using chemicals and wasting money, or under-using to the point that theyíre not getting instruments clean.

"The Verified Performance is a bit of a seal of approval, if you will," said Nielsen. "That doesnít necessarily insulate you from JCAHO inquiry, but certainly helps. It shows that youíve got a concerted system and youíve taken steps." In the same way, said Nielsen, "buying a software systemÖis equally helpful in terms of helping JCAHO or any other inspector Ė state inspector or national inspector Ė understand the level of effort and investment that your hospital has made. It helps expedite that process."

Productivity, efficiency boost

Beyond regulations and mandates, an electronic record-keeping system provides obvious productivity benefits both in terms of daily SPD tasks and in record retrieval.

Prust explained. "Itís quicker and easier for the technicians to record the information so thereís staff time associated with the speed of being able to document the information. From a management side, many facilities will do a manual tally of information monthly off of their paper systems. And an electronic system saves managers a tremendous amount of time in doing the data collection and analysis to determine department productivity and efficiency information."

In the event of a recall due to a biological indicator result, having an electronic system in place can mean "the difference between doing a search in your computer that can happen in a split-second versus going to a file cabinet or archival storage warehouse and digging through paper records," said Nielsen. "A good paper record system could get you there if itís consistently done day in and day out, but the power of automation is really no contest."

Whatís more, an electronic system can help to standardize sterilization and record-keeping methods among SPD employees with varying levels of expertise.

"Youíre introducing greater possibility for error in a paper system," said Tammy Torbert, marketing manager, 3M Sterilization Assurance. "Youíre relying upon each individual to do it the right way. Do they know what fields they need to fill in? Is it complete? Is it legible? Versus an electronic system where you have all of the prompts and you canít move forward until youíve met the requirements that the hospital has set up. So if we say, where are most hospitals lacking [in their record-keeping protocols], itís with that control aspect. Is every employee on every shift doing it the same way, the right way, the way that it needs to be done if you have to go back and look for information?"

Similarly, "records directly reflect what is being performed in the department and so poor or incomplete records can maybe mask some performance issues or training needs within a department," said Prust.

"Careful and thorough record-keeping should provide the SPD manager with data that can be used to proactively manage all sterilization processes," said SterilTekís Duckett. "The data should help the manager resolve quality issues, define training requirements, help with staffing decisions, and identify inventory issues and needs. The data should also tie back to the performance expectations of the O.R. staff and surgeons, who are the economic engine of the hospital. Overall, high quality record-keeping should provide valuable data that can help improve both internal (SPD) and external (O.R.) performance."

Another area tied to employee performance within the sterilization process that an electronic record-keeping program can help with is in the selection and use of sterility assurance indicators such as biological and chemical indicators.

"A software program can help SPD workers with the complex decisions around placing biological indicators (BIs) in individual sterilization loads," said Duckett. "Software programs for load and tray configuration can set the requirement for a BI as part of the quality control system. If an operator does not place a BI in a load that requires one, this non-conformance will become evident in the exception reports that are generated for implant loads, and may result in a recall of the load and additional operator training."

Michael Good, CEO, TGX Medical, explained how the Alex Gold system can help users with indicator verification. "As sets containing implants are scanned onto the sterilizer load via the Sterilization module, the program prompts you to add a biological. Upon confirmation the user can then continue scanning items onto the load. In addition, by using our software, and placing a biological onto the load, you will be prompted at the designated time to read the biological."

Achieving ROI

The advantages of an electronic record-keeping system are numerous, with cost-saving and productivity enhancement even beyond labor-savings.

For example, both Getingeís T-DOC and TGX Medicalís Alex Gold system provide powerful inventory management features. Not only can such systems tell you the exact location of instruments and what their maintenance and sterility status is, but can also reveal usage patterns, show where instruments typically become missing or damaged in the lifecycle process and flag critical instruments and sets for quick turnaround. This can help reduce unnecessary purchases due to lost or broken instruments, reduce excess inventory, as well as help to ensure that instruments are available when and where theyíre needed.

By integrating instrument tracking with sterilization record keeping, "this further streamlines the process and adds another level of automation for the end-user. It is a win/win for all parties involved," said Good.

Reducing or eliminating the number of cancelled or delayed O.R. procedures is a key savings opportunity. "Imagine a typical O.R. has about a $30,000/hr. operating run time with the team and the capital equipment there. If you have to delay a procedure 30 minutes while goods are being processed or sterilized, thatís significant," said Nielsen.

In additon, "many hospitals have several
million dollars in instrument inventory and if you can save 3 or 5 percent of that in terms of inventory upkeep or repurchase on an annual basis, that too is big dollars," Nielsen added.

An electronic system can also help avert seriously costly sterilization mistakes. For example, if a technician was about to steam sterilize a flexible endoscope, the system will flash a warning message. "The ROI can really accelerate rapidly when you save someone from burning up a $30,000 scope," said Nielsen.

According to Nielsen, a typical return on investment for the T-DOC system is achieved in under two years. Also, because itís is a modular system, facilities can choose to implement only the portions they want at that time. Some only automate the data-logging from the equipment, while others have a T-DOC station in every O.R. in the hospital, tracking goods down to the patient level, he said.

Prust believes that the 3M Record Keeping Software is well within reach for most facilities. "These record keeping programs are not expensive programs. When you look at some of the big major software applications in the hospital, whether they be billing programs, or surgical scheduling programs, or some of the materials management programs, youíre talking hundreds of thousands of dollars for those programs. And a record keeping software program is just a few thousand dollars. Itís a very minimal expense actually in the scheme of things."

Process improvements

If your facility is not currently in the market for an electronic record keeping program the thing to keep in mind is that a good manual process can be a life-saver in any event.

"The best alternative [to an electronic system] is a thorough manual record-keeping process that includes all the policies, procedures and work practices that can be automated at a later time," explained Duckett. "For ease of retrieval, the manual records should be stored in small Ďpackagesí of information, chronologically. I suggest they be bundled by department, by day. Most good electronic record-keeping systems are derived from their manual counterparts, so they should already have a manual system in place."

"The real trick with any of the [processes], particularly the manual system is to be sure that the people are trained, know how to use it and follow through," added 3Mís Torbert.

Conversely, "Poor records can handcuff a facility and they are at the mercy of their own tracking," said Dan Dwyer, healthcare director of marketing, Raven Biological Laboratories.

Companies such as STERIS, SPSmedical, 3M and Getinge all provide traditional paper-based record systems that are designed to promote consistent, manual record-keeping processes. Raven Biological Laboratories is just beginning to provide record keeping products.

"Raven has taken a different approach to this," noted Dwyer. "As we have developed greater relationships within specific facilities, we have asked them what they are looking for, what do they need. It is not Ravenís goal to produce and sell record keeping devices and booklets. We will provide as much as we can as downloads on our website (www.ravenlabs.com) that will allow the user to print off sheets that they can either place into a 3-ring binder or keep in another type of log book. We plan to offer a great variety of sizes and formats to accommodate those using existing log books. We do not want to offer these as additional products, however we will offer them as additional services."

"Thereís considerable room for improvement," said Duckett of current SPD record-keeping practices. "Tracking implies that youíve lost something; the goal should instead be to proactively manage loads and instruments in sterilization processes, rather than to reactively track them. Hospitals need to get better at managing their instrument inventory by applying a method similar to those used by manufacturers to manage their raw materials."

"The SPD managers and technicians are doing a great job, but theyíre fighting a 21st century war with 20th century tools, and theyíre keeping pace, to their credit," Nielsen added.

The end result

Prust challenges facilities to place greater emphasis on record-keeping policies. "Record keeping is often kind of an afterthought. We talk a lot about biological indicators and chemical indicators, but the key piece with that is that those types of indicators provide information. And itís the information that the hospital actually keeps and uses and itís important for them both from a patient safety standpoint and a compliance standpoint. It shouldnít be an afterthought at all," reiterated Prust. "That documentation provides the level of assurance that theyíre doing the right thing."

Certainly as additional mandates and regulations began to take hold in the SPD, record-keeping policies and procedures will only strengthen as a result.

"The future holds only good things for those in SPD," said Dwyer. "The mandatory certification for CS workers ensures that this profession will begin to get the respect it deserves and CS will begin to be treated as the life and money saving department it always has been. Since CS is one of the few non-revenue generating departments in a hospital, it has been incorrectly viewed as a department that only costs money. A dedicated, professional and efficient sterile processing department can be the most important department to the hospitalís bottom line because of the reduction of nosocomial infections, recalls and potential lawsuits. It is time the SPD was treated as such."

"Hospitals are beginning to realize the importance of having professionals in these particular key positions. These professionals will need the tools to help them succeed," said Good.

Source: http://hpnonline.com/inside/January06/0601CIBI.html

About TGX Medical Systems
TGX Medical Systems Inc., the Indiana-based development software firm that owns the Alex Software, is headquartered in Carmel, Indiana, USA. TGX Medical Systems designs, develops and markets software solutions for medical asset management and tracking. These web-based systems work with specialized hardware supplied by major integrators. They are sold to small, medium and large-sized hospitals and medical facilities. TGX Medical Systems's systems are distinguished from competition by their sophisticated interfaces, scalability and ease of modification and are extensively patented. Our markets are worldwide. The TGX Medical Systems website is www.tgxmedical.com.