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Medicare Takes New Steps To Help Make Your Hospital Stay Safer Monday, August 04, 2008 — Contact: CMS Office of Public Affairs, 202-690-6145 When you enter the hospital for treatment of one medical problem, you don’t expect to leave with additional injuries, infections, or other serious conditions that occur during the course of your stay. Although some of these complications may not be avoidable, too often patients suffer from injuries or illnesses that could have been prevented if the hospital had taken proper precautions. As part of its commitment to improve the quality of care you receive during a hospital stay, and to make sure that Medicare only pays for items and services that are reasonable and necessary, Medicare is taking new steps to make hospitals safer by adopting payment policies that will encourage hospitals to 1) reduce the likelihood of hospital-acquired conditions like certain infections, advanced bed sores, or fractures; and 2) reduce preventable medical errors, like performing surgery on the wrong body part, that should never happen. Hospital-Acquired Conditions
What Medicare is doing: Since October 1, 2007, hospitals have been required to report on their Medicare claims if any of the first eight selected conditions were present at the time the patient was admitted to the hospital, and beginning October 1, 2008, will have to report on the remaining conditions as well. If at discharge, there is a selected condition that was either not identified by the hospital as present on admission, or could not be identified based on data and clinical judgment at admission, it is considered hospital-acquired. To encourage hospitals to avoid hospital-acquired conditions, beginning October 1, 2008, Medicare will no longer pay hospitals at a higher rate for the increased costs of care that result when a patient is harmed by one of the listed conditions if it was hospital-acquired. Medicare prohibits the hospital from billing the beneficiary for the difference between the lower and higher payment rates. Medicare will pay for physician and other covered items or services that are needed to treat the hospital-acquired condition, including the costs of post-acute care that would not have been needed for the patient's initial medical problem, but are needed because of the hospital-acquired condition. What they are: There are some events that should never happen in a hospital. When they do occur, they can cause serious injury or death to the patient. The National Quality Forum (NQF) has defined these as Serious Reportable Adverse Events, commonly referred to as “never events.” These events are also likely to be very costly both for the beneficiary and the Medicare program. Some examples of “never events” include: What Medicare is doing: In most cases, Medicare pays only for items or services that are reasonable and necessary for the treatment of the patient’s condition, or certain preventive services required by the Medicare law. For the three wrong surgeries listed as examples above, Medicare is opening a National Coverage Decision process to look at how to ensure that patients get necessary care, but that the Medicare program would not pay the doctor and the hospital for an erroneous surgery. WHAT DOES THIS MEAN FOR ME? HOW CAN I FIND OUT MORE ABOUT QUALITY? For information about the quality of care provided by hospitals in your area, see the “Hospital Compare” feature on our Web site at www.medicare.gov.
Securing quality and safety without tape By Susan Birk Until solid information comes along to challenge old assumptions, health care practices and procedures can remain institutionally engrained for years. Even when evidence points to the benefits of change, some routines continue to retain their status as gospel. The routine use of tape to secure peripheral intravenous catheters (PIVs), still standard practice in the vast majority of hospitals, is an example. Although the use of mechanical devices as an alternative to tape has latched on somewhat for the stabilization of centrally inserted central catheters (CICCs) and peripherally inserted central catheters (PICCs), the mechanical approach to PIV maintenance, available now for several years, remains relatively untried. But that's slowly beginning to change as more hospitals learn about the devices’ potential to reduce PIV complications, save nurses time, improve safety and enhance the quality of care. The Infusion Nurses Society (INS), Norwood, Mass., formally recognizes manufactured stabilization devices as the "preferred method of securement" in its Infusion Nursing Standards of Practice. An article in a recent INS newsletter notes tape's ability to trap microorganisms and its tendency to loosen over time, a property that can contribute to catheter movement. Some theories posit that stabilization devices may reduce complications in part by restricting catheter micromotion. A study of more than 10,000 patients in 83 hospitals published in the July/August 2006 issue of the Journal of Infusion Nursing (JIN) found that the StatLock IV stabilization device yielded a 67 percent reduction in PIV-related complications and a 76 percent reduction in unscheduled PIV restarts compared with tape in one-week trials. These reductions translated into an average annual per-hospital savings of $18,000 in PIV materials and an estimated combined savings per hospital of $277,000 in materials, complication costs and nursing time. (The study was funded by StatLock IV manufacturer Venetec, San Diego.) Holmes Regional Medical Center, a 514-bed hospital located in Melbourne, Fla., is among the handful of institutions that has tested the stabilization device waters and netted itself striking reductions in PIV complications, unscheduled restarts and avoidable nursing costs. A study authored by Holmes Regiona’'s infusion team manager, Bonnie Smith, R.N., published in the January/February 2006 issue of JIN, reported a 500 percent gain in 96-hour PIV survival rates with the substitution of a StatLock stabilization device for tape. The hospital’s subsequent switch to stabilization devices has enabled it to successfully implement the 96-hour PIV change protocol recommended by the CDC, Smith reports. “With tape securement, such a protocol cannot succeed,” she concludes in the JIN study. (The CDC revised its guidelines in 2002 to allow PIVs to remain in place for 96 hours, up from the previous standard of 72 hours, as long as a hospital can keep its phlebitis rate under 5 percent.) Holmes Regional is the largest hospital in Brevard County and the largest of three that make up the not-for-profit Health First IDN. With a 500-member medical staff, the hospital provides services in oncology, cardiology, emergency and trauma medicine, orthopedics, obstetrics/gynecology and pediatrics. Health First, headquartered in Rockledge, Fla., also includes Cape Canaveral Hospital in Cocoa Beach, Fla., Palm Bay (Fla.) Community Hospital, and several other services and facilities, including a heart institute. “It’s not cost effective in patients who are not going to require a PIV for more than 24 hours,” Inbornone notes. For patients who do need PIVs longer than 24 hours, Health First has found the device to be cost-neutral compared with tape. However, the device has enabled the system to achieve savings of approximately $10,000 per month in salary dollars. Health First’s shift from tape to mechanical PIV stabilization began when a member of Smith’s 17-member infusion nursing team returned from the 2003 annual meeting of the Infusion Nurses Society (INS) with information about research being conducted by Venetec. The company was offering hospitals the opportunity to pilot test its StatLock IV Ultra stabilization device for PIVs. At the time, 15 percent of Holmes Regional’s PIVs were lasting 72 hours, according to Smith, who notes that the hospital’s infusion nursing staff has collected comprehensive IV data for 25 years. When the hospital attempted to implement the 96-hour protocol, its PIV survival rate dropped by 50 percent. “Going to four days was supposed to save us money, but we were running ragged doing unscheduled restarts,” Smith says. “So many of the 15 percent of IVs that were perfect at 72 hours were not making it to the fourth day. We were spending most of our time running up and down the hall, never getting anything done.” On trial Following the INS meeting, and with approval from Health First's Medical/Surgical Value Analysis Team, Holmes Regional embarked on one-week trial comparisons of StatLock, a sterile surgical tape that the hospital had never used for PIVs and traditional nonsterile tape. The hospital chose a “difficult” floor for the trials largely composed of geriatric patients, most of whom were being treated for serious respiratory conditions and were receiving intravenous antibiotics and other intravenous medications. According to Smith, Venetec’s data collection sheet "looked almost identical to the one we’d been using for 25 years." Results from the tape trial closely matched the hospital's previous tape experience, providing further support for the study’s validity. With StatLock, the 96-hour PIV survival rate rose to 52 percent from the 8 percent that had occurred with tape. (The use of sterile tape yielded a 9 percent survival rate that was statistically insignificant from the nonsterile tape results.) Six months after the initial StatLock trial, which included 38 patients, the hospital conducted a follow-up investigation of 248 additional patients (part of the total 650-patient sample included in the JIN study). This trial revealed a survival rate of 52 percent as well. Smith says she and her staff had no idea until these product evaluations were conducted that tape was contributing to many of the hospital's PIV failures. “We just thought that IVs aren’t meant to be in your body for four days,” she says. With StatLock, Holmes Regional now saves an average of approximately $100,000 per year on avoidable nursing costs, including overtime pay, which had risen dramatically due to decreased productivity with implementation of the 96-hour protocol. Smith’s initial discovery of these savings came as a surprise. More than savings But the dollar savings are only part of the picture. Lance Perkins, director of StatLock marketing at Bard Medical, which recently acquired Venetec, believes StatLock’s ability to improve clinical outcomes and economic efficiencies helps hospitals improve the quality of care. “From a quality standpoint, there’s something there for both the patient in terms of greater satisfaction, greater comfort and fewer complications, and for the health care worker in terms of reduced chances of accidental needlesticks,” he says. Smith agrees. Many patients have made positive comments about the devices. The change also has allowed the infusion nursing staff to focus more on patient needs. “Before StatLock, we were just slapping in an IV and running to the next call. With StatLock, we began to provide better nursing care because we had more time to evaluate patients for what they really needed.” Nurses also have had more time to focus their expertise on the placement and management of PICCs and CICCs. “We’re doing more and using less.” Smith’s team was skeptical at first that a securement device could make an IV last longer. But as soon as they saw the results, they wanted to start using it. “The IV nurses really want their IVs to stay in. I don't have anybody not wanting to use a StatLock,” she says. She advises other institutions that may be considering a change to begin with careful data collection. “Every hospital needs to monitor their reasons for restarts. If they don’t do a study, they may not realize they have a problem,” she says. “I know that other hospitals are having the same issue. But if they don’t record the data, they’re just being blinded by the lack of information.” Susan Birk is a freelance writer based in Wheaton, Ill. New standards for improving peripheral I.V. catheter securement SMITH, BONNIE RN, CRNI; ROYER, TIMOTHY IAN CRNI, BSN UNTIL A FEW YEARS ago, peripheral I.V. catheters were secured at our two institutions with the traditional method, using nonsterile tape. But this method caused problems, including unsatisfactory levels of catheter-related complications and high rates of unscheduled catheter restarts. Although we focused on different issues at each facility, we ultimately resolved them in the same way: by switching to a customized catheter securement device that had proved effective in prospective clinical research. Our research helped form the evidence base for recent revisions to the Infusion Nursing Standards of Practice, issued by the Infusion Nurses Society (INS).1 The INS is one of the foremost organizations concerned with I.V. infusion and safety. In this article, we describe research conducted at our institutions: a regional medical center in Florida and a Veterans Affairs (VA) health care system in Washington State. We also describe our analysis of a specific securement protocol and device and explain our protocol to hold peripheral I.V. catheters in place. Extending dwell time to 96 hours: Holmes's experience Nurses at Holmes Regional Medical Center (Melbourne, Fla.) had long recognized problems with tape securement of peripheral I.V. devices, even though there was no obvious solution. Our catheter change protocol stipulated that all such catheters be changed after 72 hours. Few lines lasted that long, however, due to the inadequacy of tape securement. In October 2002, Holmes decided to implement a 96-hour catheter-change protocol for peripheral I.V. lines. This complied with Centers for Disease Control and Prevention guidelines, which state, replace peripheral venous catheters at least every 72-96 hours in adults to prevent phlebitis.2 But with the new regimen, our rate for unscheduled restarts jumped even higher. Nurses already stressed by frequent catheter restarts found they were getting even less of their routine work done. When we analyzed our data retrospectively, we saw the dimensions of the problem. Under the 72-hour protocol, only 15% of catheters had made it to the maximum time allowed. Adopting the 96-hour protocol drove the catheter survival rate down to 8%-a drop of almost 50%. Holmes’s management had originally hoped the 96-hour protocol would save nursing time and material costs. Rather than give up on that goal, managers uncovered research on a promising alternative: a manufactured catheter securement/stabilization device called StatLock. The customized device consists of two parts:
Published studies and articles about this customized device-with different designs for all types of catheters-reported dramatic reductions in catheter-related complications, unscheduled restarts, and nursing minutes per catheter. Subsequently, management decided to also test another securement alternative, an adhesive-backed foam device called HubGuard. This option initially looked less expensive, based on the cost of materials.
In this three-way competition, the customized StatLock device emerged as the clear winner: About 52% of catheters secured with this device survived to 96 hours. By comparison, only 8% of the taped catheters and 9% of catheters secured with the HubGuard device survived for 96 hours. Based on those results, the StatLock device was adopted for systemwide use by Holmes’s parent health care organization. About 6 months after the original trial was completed, the device was evaluated again in a larger trial involving 248 patients. Again, 52% of the catheters secured with it lasted 96 hours. Our experience led us to conclude that this new device protocol can improve patient safety, increase nurse productivity, and save vascular access costs. Reducing I.V.-related complications: The VA system’s experience At the VA Puget Sound (Wash.) Health Care System, nursing management was also concerned about the problems associated with tape securement. In this case, however, attention was centered less on restarts than on complications. The process began with gathering 2 years of data on peripheral I.V. catheter use. This data showed unacceptably high complication rates in several key categories: infiltration, leaking, dislodgment, phlebitis, and occlusion. We reviewed the literature and concluded that tape securement, which can allow catheter micromovements inside the vessel, was the likely culprit. No matter how well an I.V. device is taped, the tape is likely to come at least partly undone well before the catheter is scheduled to be changed, so we also searched the literature for an alternative. The most promising solution turned out to be the same StatLock device tested at Holmes. Research suggested it reduced restarts and patient complications by minimizing catheter micromovements. We wanted to study the device and its associated protocol at our own institution, so we set up a 2-week trial involving both an acute medical unit and a surgical unit. The first week, all peripheral I.V. lines for patients in both units were secured with tape. The following week, all peripheral I.V. lines were secured with the StatLock device. As at Holmes, the results were unequivocal. Using the StatLock device reduced total complications by 42% and the unscheduled restart rate by 63%. Saving nursing time was another priority we shared with Holmes. Drawing on data from the trial, we projected the potential annual impact on productivity if we adopted the device throughout our system. We found the device would eliminate 1,660 unplanned restarts per year, which meant 553 nursing hours could be redirected from restarts to other patient-care activities. Although initial material costs were greater for the customized device, our calculations showed that these costs were essentially offset by the savings from fewer restarts and reduced nursing time. Another factor in the device's favor was a substantially lower risk of accidental needle-stick injury, which was also linked to the reduction in restarts. Accordingly, our commodities board approved implementation of the device. Since then, our data continue to justify the board's decision. The INS concurs The INS standards issued in January 2006 underline the conclusions drawn earlier at Holmes and the VA Puget Sound Health Care System. The Infusion Nursing Standards of Practice state a preference for precisely the customized device and protocol used at our two institutions.1 After examining peer-reviewed studies, the INS named three types of products as acceptable for catheter stabilization. These include manufactured catheter stabilization devices, sterile tapes, and surgical strips. Whenever feasible, the standards go on to say, using a manufactured catheter stabilization device is preferred.1 While the INS doesn't endorse or recommend specific products, the customized device we evaluated at our facilities is the only one that currently meets the new national standards based on scientific evidence. These new standards validate our own data. That makes us even more confident that when it comes to holding catheters tight, we’re using the right solution-one that can be readily implemented by virtually all other facilities that place peripheral I.V. devices. REFERENCES 1. Infusion Nurses Society. Infusion Nursing Standards of Practice. Journal of Infusion Nursing. 29(1 Suppl.):S1-S92, January-February 2006. 2. Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular catheter-related infections. Morbidity and Mortality Weekly Report. 51(No. RR-10), August 9, 2002.
By Steve Bierman, MD Would you accept a device into your institution that has a 65 percent or greater failure rate? Would you allow vascular access devices to be secured with a device known to be contaminated with pathogenic bacteria 74 percent of the time? Would you tolerate a 48 percent or greater catheter complication rate—and the attendant obligation of nurse time to troubleshoot and restart catheters—when a truly cost-effective alternative has been proven in literally scores of institutions to reduce such complications to 16 percent? Most likely, your answer to all three questions is a definitive “No.” And yet, chances are you have unwittingly allowed all of these awful events to occur, and to 80 percent of your patients. But you are not alone. Thousands of hospitals are currently immersed in the same sea of avoidable complications and infections. This is an era in medicine when nursing time is at a premium, and when hospitals face economic pressures to evaluate the cost-effectiveness of the devices and procedures they employ. It is an era in which institutions are mandated to protect nurses against unnecessary exposure to medical sharps and accidental needlesticks—a goal that can be achieved in part by eliminating unnecessary catheter restarts. And it is also a time when hospitals face pressure from JCAHO and Medicare to improve patient safety. Fortunately, there is a safe harbor ahead. As we shall see, tape is the offending device with the high failure rate, the intolerable contamination risk, and the associated and unallowable complication rates. The culprit is not the sterile tape you use to hold surgical bandages in place; rather, it's the non-sterile tape you pull out of your pocket or off a Mayo stand and use to secure peripheral IV (PIV) catheters. Tape causes complications and promotes infections—all of which also consume precious nursing time. But there is now a safe, cost-effective and abundantly proven alternative method available to secure PIVs. The implementation of this new securement method (StatLock, manufactured by Venetec International) dramatically improves clinical outcomes, while at the same time returning valuable time to nurses and reducing overall material costs to the institution. As background, it is important to first become familiar with some baseline data. At least 80 percent of all hospitalized patients receive intravenous therapy through peripheral IV catheters. Though PIVs become infected far less frequently than central venous catheters, staphylococcal infections of PIVs are not a rarity. Moreover, complications such as infiltration, phlebitis, dislodgment, migration, and extravasations—are quite common with PIVs. Further, because of these frequent complications, the average PIV catheter dwell-time in hospitals is 44 hours, making routine 72-hour scheduled IV restarts more of a wish than a reality.1 Finally, this shortened dwell-time translates into a total average of 36 minutes of troubleshooting and restarting PIVs. That means a nurse charged with watching four IVs will spend more than two full hours (15 minutes here, 10 minutes there) unnecessarily attending to those IVs over the course of therapy.1 This is today’s reality in most hospitals. Generally speaking, nurses see this welter of PIV-associated problems and complications as the unavoidable consequences of sticking a relatively hard plastic cannula into a delicate peripheral vein: “Complications,” they say, “are bound to happen.” Are they? If so, why in one study was the average dwell-time of a Teflon PIV extended to 95 hours?2 And why, in that same study, were total complications able to be reduced by 58 percent? The answer is quite simple, if often overlooked—securement. Think of it this way: It is not the catheter that causes complications, but rather movement of the catheter. Catheter movement pistons staphylococci at the entry site in and out of the wound. Catheter tip movement harasses the blood vessel lining, triggering inflammation, thrombosis, and eventual erosion. If you stop catheter movement, you can greatly reduce, and in some cases eliminate, complications. And how do you stop catheter movement? First, you commit to abandoning tape. Then, you test and prove out in your institution a sterile adhesive catheter securement device and implement it housewide, while at the same time changing your PIV protocol to 96-hour scheduled restarts. This will prevent complications, and save considerable time and money. After all, tape was never really appropriate as a PIV securement device. It was simply all that we had. Consider this: In 1999, the University of Toronto published an elegant study demonstrating that after only 24 hours, 74 percent of tape samples (taken from rolls used to secure PIVs) cultured positive for pathogenic bacteria.3 In the hospital study previously cited, tape allowed a 65 percent rate of PIV complications, resulting in a 63 percent rate of PIV unscheduled restarts (meaning they had to restart 63 of every 100 catheters before the scheduled 72-hour change-out). Beyond that, tape has been clearly demonstrated to tear gloves, thus exposing healthcare workers to dangerous cutaneous contamination from bloodborne pathogens.4 And, well known to all clinicians, tape injures skin at rates up to 67 percent.2 In sum, any objective look at the evidence can lead to only one conclusion: Tape, as a PIV securement device, is a dirty business. The landmark 1997 study, published in the Journal of Intravenous Nursing, established the baseline complication rate, unscheduled restart rate, and nursing-time consumption associated with taped PIVs.1 The study went on to prospectively (though non-randomly) assess the performance of the sterile StatLock adhesive securement device with regard to these same parameters. The results were astounding. StatLock, owing to a sterile, plastic-on-plastic interface that dramatically restricts catheter movement, was demonstrated to reduce PIV-related complications by 72 percent. The device also reduced unscheduled restarts by 74 percent and saved nurses 29 minutes per IV during the extended lifetime of the catheter. Subsequent studies in homecare and skilled nursing facilities demonstrated similar findings.2,5 Most dramatically, the StatLock manufacturer subsequently undertook to conduct and sponsor literally scores of sequential trials comparing StatLock PIV securement to tape securement.6 These trials were conducted in institutions wishing to: first, discover their own baseline data; and second, determine if StatLock would/could provide cost-effective improvement to patient care. In all, 66 institutions are represented in these trials. Tape securement of PIVs, on average, resulted in an unscheduled restart rate of 71 percent and a total complication rate (including complications on restarted PIVs) of 47 percent. Included in those total complications was an average phlebitis rate of 4.9 percent. Results at these 66 institutions, which confirm the results published in the original 1997 study, showed a 76 percent reduction in unscheduled restarts, and a 66 percent reduction in total complications, including a 75 percent reduction in phlebitis from using StatLock to secure PIVs. Most remarkable is the fact that in 33 of 66 institutions, the StatLock securement device accounted for 100 percent elimination of phlebitis—a complication that prior to the studies had generally been accepted as inevitable. Why? Because, as these studies demonstrate, even so-called “chemical phlebitis” begins with injury to the intima, which results from catheter movement. Think of it: 33 institutions in which the phlebitis rate was actually reduced to zero. Tape was not invented for catheter securement. Tape was and is intended to hold flat objects to flat surfaces. Sterile, precision-engineered catheter securement devices have been consistently outperforming tape for securement of PIVs since 1997. There is a new standard of care for peripheral IV catheters. Polyurethane safety catheters are now being secured with sterile adhesive-anchor devices that save time and money by preventing complications and protecting healthcare workers. This new standard will allow your institution to move effectively to the CDC-sanctioned, 96-hour scheduled PIV restart protocol. The new standard also enables facilities to satisfy Joint Commission on the Accreditation of Healthcare Organization (JCAHO) patient safety concerns, and to meet the mandates of the U.S. Needlestick Safety and Prevention Act. Tape, as a makeshift catheter securement device, is a documented dirty business whose time in the hospital has passed. Steve Bierman, MD, is the medical director and CEO of Venetec International.
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