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By Kelly M. Pyrek
By Kelly M. Pyrek
Robert Orenstein, DO, associate professor in the Division of Infectious Diseases, Infection Prevention and Control at Mayo Clinic in Rochester, Minn., has devised an environmental hygiene intervention so successful it has reduced Clostridium difficile acquisition rates by one-third in high-risk units. This deceptively simple intervention involves consistent daily cleaning of all high-touch surfaces with a spore-killing bleach disinfectant wipe for all patients on units with high endemic rates of C. difficile infection (CDI). Orenstein emphasizes that despite this seeming simplicity, a great deal of collaboration and communication was required, as was strong buy-in by administrators and staff.
Essentially there has just been one nosocomial case on the two units upon which the intervention was practiced, according to Orenstein, who reports that the goal to reduce hospital-acquired C. difficile infection rates in these high-incidence units by 30 percent was far exceeded. "When the study concluded near the end of last year, one unit had gone 137 days without a hospital-acquired C. difficile infection," Orenstein says.
The hospital rooms in the study were part of two units that housed general, gastrointestinal and pulmonary disease patients, averaging 39 patients a day. Each of these units has had high endemic rates of this infection. When the study began, one unit's infection frequency was 61 per 10,000 patient days. The other was higher, at 106 cases per 10,000 patient days. The bleach wipes -- containing 0.55 percent sodium hypochlorite -- were selected because the bleach solution is the only product registered with the U.S. Environmental Protection Agency (EPA) as effective against C. difficile spores. C. difficile is the one of the leading pathogens causing hospital-acquired infection in the United States. It may cause diarrhea, colitis, sepsis and lead to prolonged hospitalization and death.
When Orenstein was first considering an intervention project, he thought about conducting a universal gloving protocol study but that plan was short-lived. "We have two hospitals here in one we have universal gloving on some units for hematology/oncology patients while in the other facility we do not have universal gloving," he says. "We thought about doing a universal gloving protocol to see if the C. diff rates would be lower but then the logistics became a horror story -- I find it incredible that it was that hard to put gloves on a door and make people wear them going into a room. The way the hospital is organized we couldnt do it so we decided to look at other measures."
Orenstein continues, Everyone is talking about bleaching rooms, but no one was really talking about doing it every day; the Cleveland Clinic has data showing that patients are contaminated with C. diff spores, the rooms are contaminated with the spores and a lot of hospitals keep people in isolation and as soon as their diarrhea is done they are out of isolation so that means that all those spores are still in the room and people are walking in and out, carrying them elsewhere. So we said, Why dont we find a sporicidal agent thats easy to use and we will just clean every room on our highest-risk units every day?
So we met with our environmental services people and achieved buy-in with them, and then we worked with the Clorox Company, which had just received approval for their C. diff product. We knew the environmental services staff would like a one-step process to clean and disinfect the patient room. We then brought infection prevention and quality together with environmental services and made a plan to tackle our two high-risk units to see if we can bring down the rates. Everyone talks about cleaning the room and reducing environmental contamination but nobody shows that actually doing that reduces infections."
Orenstein says that Clean Trace, an adenosine triphosphate (ATP)-based bioluminescence product, was used to monitor the rooms level of environmental hygiene during the wipes intervention to ensure that the cleaning was indeed being conducted by environmental services staff. Particular attention was paid to the high-touch surfaces, ensuring that these transmission hot spots were being cleaned using the bleach wipes.
"We continued to meet with the environmental services staff every couple of weeks to ensure that they were doing OK and didnt have any issues with the cleaning protocol," Orenstein says. "Environmental services personnel did raise concerns about the smell of the bleach, which was expected since they were the ones working with it predominantly; we dealt with those issues immediately and showed them that we cared about them and that we wanted them to be comfortable and safe when using the bleach product. Interestingly enough, the patients actually did not complain about the cleaning protocol."
Orenstein continues, "We saw the data at about three months and it looked really good. Rates suddenly started coming down. We originally said wed do this intervention for six months and increase the time between cases from our average of 10 days we said well get to 20 days, and well look at reducing the total number of infections by 20 percent. We didnt want to set the bar too high because we didnt know if it would work. After that first three months it looked like we were already getting there, and we all got excited and I said, Dont get too excited because these rates go up and down. Four or five months later, we still hadnt seen a case and people were asking whats going on and we said, It looks like a really good intervention."
It can be difficult in the early stages of an intervention to determine its effectiveness; however, Orenstein says a strong visual cue told him the cleaning protocol was working. "One of the things we noticed observation-wise was the presence or lack thereof of isolation carts. We have all these carts on the floor for patients in strict isolation; when I started going up to the floor I noticed that suddenly, there were no isolation carts. I thought to myself, This is really strange this unit used to be hard to walk through, there were so many carts. Clearly somethings happening."
And it was, thanks to the environmental services staff that, Orenstein says, was showered with praise for their efforts. "We would continue to meet with the environmental services staff to show them how well they were doing, congratulating them for doing such a great job. We kept up these collective efforts and now we are at one year and there was just one nosocomial case on one unit, and zero nosocomial cases on the highest risk unit of the hospital, the unit that gets all the transfers from community hospitals that have Clostridium difficile infection, ulcerative colitis and Crohns patients -- a big burden of disease, and not a single case on that unit for a year. We monitor both the nosocomial cases and the incident cases the incident cases were still high, but we never had any transmission, something that I think is really great."
While the cleaning intervention achieved a significant reduction in infections, Orenstein says other factors, such as observation of evidence-based infection prevention and control practices, helped further create a hygienic environment. And it didnt hurt that the healthcare institution leadership demonstrated its support early and often.
"The institution is very committed to quality and to patient safety," Orenstein says. "The reason this intervention became a reality is that we went to the appropriate committees and asked for support and got it. Then when we showed them the data that we were doing so well, they said, You need to move this elsewhere, so we moved it over to the other hospital and weve been conducting the cleaning protocol in three units there; on two out of the three units we have seen similar results. Those units are at four or five months, so we then presented that data again to our clinical quality committee and they said, You need to be doing this across the institution. I did tell them that you really want the biggest bang for your buck, and if you conduct this cleaning in every room every day, thats a lot of expense and a lot of extra time. I suggested we do the cleaning protocol in the high-risk areas, and for those patients who have lower risk well just do what we call strict isolation rooms those are rooms that house patients with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) or Clostridium difficile. Those rooms we will now do the daily cleaning with the bleach wipes and the units we do surveillance on that have the highest rates well do the daily cleaning that we did on these other units and see if we can bring their rates down too. So my anticipation is with that approach, our Clostridium difficile rates should drop dramatically, and when we looked at our hospital-wide rates, just by dropping it on those first two units we had a big drop in hospital-acquired rates. We are exporting this intervention to our other two hospitals in Florida and Arizona and hoping we will see some similar results."
Orenstein adds, "You would think that it would be a very simple intervention but it really does require a significant team effort and buy-in from everyone, including patients. We surveyed our patients on a regular basis throughout the intervention to make sure they were OK with the cleaning protocol and we also surveyed our environmental services staff. That data was presented by our infection preventionist, Kimberly Aronhalt, RN, at the recent annual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC)."
Orenstein and his colleagues at Mayo Clinic -- James McManus, Leslie Fedraw, Linda Grupa, Kimberly Aronhalt, Laurie Czaplewski, Michelle Hedin, Lynn Johnson, Kristin Negley, Amy Zwygart and Conor Loftus presented their study data at the Fifth Decennial International Conference on Healthcare-Acquired Infections held in Atlanta in March and sponsored by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA) and the Centers for Disease Control and Prevention (CDC). Orenstein says he is hoping to publish his findings in the journal Infection Control and Hospital Epidemiology, and until then, continues to field inquiries about the intervention.
"Since Decennial, I have received many calls from healthcare institutions around the country," Orenstein says. "I have sent them our poster and shared with them the mechanism by which we did this intervention, so I am hoping other clinicians will be able to replicate the results. Maybe this needs to be one of the best practices that all hospitals adopt."
Orenstein says hes not content to merely continue to collect data and encourages others in the infection prevention and control community to shake off the status-quo mindset.
"My vision is to try to do interventional projects in infection prevention because for too long all we have done is collect the data but now we need to act and do something," he says. "The time to do it is now; we are gathering all of this data, we are submitting it for national reporting, yet we dont do anything about it. Thats great that you have data, but what have you actually done with it? SHEAs new research group is a start; we need to tackle real problems, and not just collect information and say, This is a problem. Lets start doing something about it."
Study Snapshot from Decennial
A Targeted Strategy to Wipe Out C. difficile
Patients and staff tolerated this daily cleaning with the bleach wipes without significant concerns. Researchers concluded that this type of disinfection process was effective at reducing C. difficile infections on these units and should be instituted in other hospital units with high infection rates.
The study was initiated, designed and financed by Mayo Clinic.
Background: Based upon prior surveillance we identified units with high endemic rates of C. difficile infection. As part of a strategy to reduce healthcare-associated Clostridium difficile infection (CDI) we targeted two units with high colonization pressure for a single focused intervention -- daily and terminal cleaning of all patient rooms with Clorox ultra germicidal bleach wipes containing 6.15 percent sodium hypochlorite.
1. Reduce hospital acquired C. difficile infection rates on two very high-risk units by 30 percent
2. Increase the interval between hospital-acquired cases of C. difficile to >20 days.
3. Ensure all rooms on high-risk units are effectively cleaned using Clean Trace technology
Methods: Controlled before-and-after study. Incidence rates of C. difficile infection were recorded for units A and B for the quarter year and entire year prior to initiation of the change in environmental cleaning from a quarternary ammonium compound to the new bleach product. Environmental services personnel were trained to use Clorox ultra germicidal bleach wipes 6.15 percent 5,200 ppm active chlorine, for daily and terminal cleaning of all rooms on these two contiguous units beginning in August 2009. Cleaning of rooms was assessed by supervisors and via use of Clean Trace technology on a random sample of rooms before and during the intervention. Surveys were obtained to assess satisfaction and tolerance from patients and environmental services employees before and during the intervention. Strict isolation compliance was recorded by a standardized observation method before and during the intervention. Infection prevention and control monitored overall CDI incidence, healthcare-acquired CDI incidence, compliance with the interventions, and satisfaction surveys of patients, staff and ES employees.
Results: Incidence of healthcare-acquired CDI
Reduce hospital-acquired Clostridium difficile infections (CDI) on Units A and B
-- Before: 18.4 (healthcare-acquired CDl infections per 10,000 patient days)
-- After: 3.7
Time between healthcare-acquired cases of CDI
Increase the number of days between hospital-acquired cases of C. diff infection incidence on units
-- Before: 13 days
-- After: 74 days
As of November 2009, intervention unit A has gone 137 days and B has gone 74 days without healthcare-acquired CDI.
Monthly monitoring of strict isolation compliance
-- Before: First quarter: A: 80 percent; B: 70 percent
-- After: First quarter: A: 80 percent; B 97 percent
Room cleaning by Clean Trace technology
All patient rooms are cleaned using germicidal bleach wipes daily and at terminal dismissal standards by environmental services staff.
-- Before: 100 percent of rooms; five rooms audited using Clean Trace; audits met the standard of 90 percent of swabs will have readings of < 250 RLU.
-- After: 100 percent of rooms; five had a 100 percent pass rate
Patients tolerated the cleaning with no concerns. Environmental services employees initially had concerns regarding odor and irritation but these were resolved.
Conclusion: Ultra germicidal bleach wipes were well tolerated by patients and effectively reduced the incidence and time between cases of healthcare acquired Clostridium difficile infections on a high-incidence medical unit.