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By Kathy Dix
Any healthcare setting has issues related to infectious diseases and the safety of both patients and staff, but the dialysis setting has its own concerns. Renal care patients may carry bloodborne pathogens, and therefore pose a risk to the healthcare workers (HCWs) treating them and to the other patients being treated in the dialysis center. They may have weakened immune systems and be more vulnerable to infection themselves, and since sharps abound, everyone in the vicinity is at risk.
It may not be an issue of adding extra precautions, but simply following current standard precautions, or the more exacting contact precautions with specific patients for whom this is indicated.
The potential to transmit pathogens in the dialysis setting has been addressed by a separate set of precautions released by the Centers for Disease Control and Prevention (CDC), as Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, says Ginger Hanson, RN, CNN, director of quality management for DaVita.
In 1977, the CDC first published recommendations for the control of hepatitis B in dialysis, Hanson points out. This was later replaced by the current recommendations for preventing the transmission of infections in dialysis facilities. These recommendations include:
Tracking Infections and Benchmarking
Each dialysis center monitors its own infection rates. At DaVita, these results are summarized monthly and sent via the Clinical Services Team to Quality Management (QM) at DaVita. QM then rolls up this information for Division, Group, and company-wide infection surveillance, Hanson explains.
Â We monitor vascular access infections as well as other dialysis and non-dialysis related infections. We track bacteria associated with vascular access as well as secondary infections not associated with the vascular access.
DaVita has created a program to follow up with facilities that report higher rates, by providing assistance and support for staff. The program is called DISINFECT DaVitas Initiative To Stop Infections through Notification, Follow-up, Education, Continuous improvement, and Teamwork program.
Hospital dialysis departments handle both inpatients and outpatients, but infection control is required in both populations. Hemodialysis patients have an increased risk of infection due to the fact that dialysis requires vascular access for prolonged periods of time. During the dialysis process, where multiple patients receive dialysis at the same time, there are repeated opportunities for transmission of infectious organisms, says Angela Hammer, MT, MS, CIC, corporate manager of infection prevention at Childrens Memorial Hospital in Chicago.
Like many hospitals, DaVita clinics have an infection surveillance committee that monitors infections, evaluates the dialysis centers current action plans, and changes the programs based on need and response. This year, we will be improving our DISINFECT program to become more interactive with individuals in the facilities, says Hanson. Currently, notifications and follow-ups are conducted via e-mail. For 2007, the process will link facilities at the division level with interactive conference calls between DaVitas clinical services teams and facilities to help provide an efficient forum for questions and instant feedback.
Facilities are required to track at a minimum positive serum cultures, positive central venous catheter (CVC) exit site culture swabs, hospitalizations related to both, IV antibiotic starts, and peripheral access infections, observes Shelly Padovan, RN, CNN, clinical specialist for Alcavis International. Units often also track and discuss at multi-disciplinary meetings the following topics: pre and treated water cultures and endotoxin results, peritoneal dialysis catheter exit site infections, tunnel infections and peritonitis events, and monitoring of drug-resistant infections. These monthly/quarterly meetings and surveillance data results often provide information to quickly identify problems and target control measures. The Centers for Medicare and Medicaid Services (CMS) mandate these and other quality control outcomes to be made available. Quality assurance (QA) meeting data is passed up the facility food chain to the corporate level for tracking and action. Often, dialysis clinics compete for best outcomes with award programs to incentivize staff to strive to improve all quality of care.
Many centers and dialysis chains work closely with the CDCs Dialysis Surveillance Network (DSN), a voluntary national surveillance system monitoring bloodstream and vascular infections. Both adult and pediatric dialysis centers treating outpatients are invited to participate.
Fistula First is a program geared toward increasing fistula rates and subsequently decreasing infections, he continues. This program is offered by the Centers for Medicare and Medicaid (CMS), and more information about the program is available at www.fistulafirst.org.
There are other databases that provide comparisons of the dialysis community, and those include:
With regard to the DSN, I believe that phase of CMS data collection was completed in 2005, and we are seeing the CDC rollout of the national healthcare safety network (NHSN). The CDC plans to open enrollment to all outpatient dialysis units not already in the DSN. The NSHN will collect data about general infection control practices and facility characteristics, providing critical statistics with regard to infection incidence within the outpatient dialysis population. CMS also has put forth the Fistula First Initiative that should expedite the goal of increasing the percentage of functioning fistulae as primary access, decreasing infection rates, hospitalizations and morbidity associated with this large problem, Padovan says.
Benchmarking is used to help all centers strive to be their best. National cooperation with the NHSH will clarify which issues require immediate attention with regard to practice change. On a local level, dialysis chains either large or small that understand the importance of staff education, the need for quality improvement (QI) nurses, and prioritize solid IC practice, are ahead of the game, Padovan says. The CDC has a set of standard precautions to be followed by dialysis facilities that should be consistently adhered to, such as gloving, handwashing, face shields, dedicated clean and dirty areas, segregation of machines and equipment, proper personal protective equipment (PPE), etc.
Padovan concludes, There is sometimes a less than top priority with infection control in dialysis centers. They do not have a strong tie to the Occupational Health and Safety Administration (OSHA), the Joint Commission, and the Centers for Medicare and Medicaid Services (CMS) at the facility level (like an inpatient/hospital situation does). The USRDS states that infections are the second-leading cause of death in the chronic renal population.
Deficient practices should be monitored and corrected internally with a strong and diligent QC process. All should be responsible for monitoring and correcting poor practice (CMS, state surveyors, management, doctors, staff, staff educators, QA/ QC nurses, patients and families). Simple things like enforcing common infection control practices, providing education, and positive reinforcement while improving outcomes keep the momentum rolling and move clinics closer to their goals.
These infection control practices include the following:
Recommendations for Specific Pathogens
Because hepatitis B is such a risk in this patient population, the HBV vaccination is recommended for all dialysis patients.
Dialysis patients who are known to be infected with hepatitis B should be isolated for dialysis in a separate room, with a dedicated machine and other equipment, Hammer says. In addition, staff caring for a hepatitis B positive patient during dialysis should not care for a HBV-negative patient on that day. Dialysis patients should be screened monthly for newly acquired hepatitis B so that they can be appropriately isolated during dialysis. Hepatitis C positive patients do not require isolation, but attention to strict infection control practices will prevent transmission. Hepatitis C negative dialysis patients should be tested every six months for antibodies to HCV to detect patients with newly acquired infection.
Although hepatitis B is isolated, this can be virtual - by cohorting patients at certain stations, says Wayne Carlson, director of clinical services for Minntech Renal Systems.
Certain steps should be followed for every patient, no matter what their infectious disease status. Medications labeled as single use should only be punctured once, and medications should never be pooled, she points out. Segregate contaminated supplies, contaminated equipment, lab specimens, and biohazard containers from areas where medications and clean equipment/supplies are handled. When initiating and discontinuing dialysis, staff should wear PPE. And the dialysis station/patient area should be thoroughly cleaned/disinfected (bed, chair, surfaces, outside surfaces of dialysis machine, scissors, hemostats/clamps, blood pressure cuffs, stethoscopes) between patients.
It is important to note that no transmission of human immunodeficiency virus (HIV) has been reported in U.S. hemodialysis centers; therefore there are no specific infection control practice recommendations for HIV positive patients, Hammer observes.
Hepatitis B is one of the major bloodborne pathogens monitored by DaVita. The CDC also has recommendations for hepatitis C testing, but such tests are not reimbursed by CMS, Hanson points out. The physician council and PLAC review these recommendations on a regular basis. There are no specific recommendations for HIV provided by CDC, and screening patients for HIV is not recommended.
Chronic patients are more susceptible to infections, frequently with antimicrobialresistant organisms. Immunosuppression, frequent accessing of the vasculature, frequent hospitalizations, and company-morbid conditions are contributing causes, Padovan says. It has been documented that the dialysis population has a higher incidence of hepatitis C virus (HCV). It currently is common practice (per CDC Guidelines) to schedule HBsAg, anti-HBc, anti-HBs, anti-CHCV and ALT testing on all new outpatient renal admissions, including new starts in a hospitalized scenario. Depending on serum results, there are guidelines for maintenance testing of hepatitis B virus (HBV) and HCV. It is not mandated to test for HIV.
All patients should be cared for using universal precautions while in the dialysis centers. And, Padovan adds, Most dialysis entities enforce infection control practices with internal policies and procedures that are required to be abided to. These principles and practices provide external agencies and surveyors a means to ensure the facility is meeting what it mandates as daily practice. Regional infection control or QA nurses monitor staff handwashing, PPE, isolation and segregation of patients that require such, disposal of sharps and waste (infectious vs. safe), proper cleaning of machines and surfaces, timeliness of lab reporting, routine cross-infection avoidance, vaccine schedules and booster needs.
Products to Reduce Infection Rates
Alcavis is concerned with preventing infections.
To do this, we have divided the dialysis infection control market into five areas, says Gary Mishkin, vice president of research and development at Alcavis International, Inc. These areas include:
a) Dialyzer reuse
b) Patient care/access care
c) Hand antisepsis
d) Disinfection of equipment
e) Surface cleaning and disinfection
The company has created solutions for each area of focus, including an ARM dialyzer reprocessing system. And for patient care, two specific products prove popular wherever skin antisepsis is required, ExSept Plus is used, and Alcavis 50 is used when disinfecting the catheter connections. Both products are a proprietary sodium hypochlorite solution, he adds. These products have been shown to be compatible with silicone and polyurethane materials such as CarbothaneÂ® and TecoflexÂ®. This is important when contacting catheter materials, commonly used in dialysis. Using the incorrect solution on a catheter can lead to catheter degradation and possibly breaking of the catheter itself, which can be fatal.
For hand antisepsis, there are two alcoholbased antiseptics, Aniosgel Plus, without color and without perfume and Manugel 85 with color and perfume, with efficacy at 30 seconds of up to 99.999 percent (5 log) reduction in bacterial counts.
Disinfection of equipment includes the hydraulic path of dialysis machines and the fluid path of the clinic. There are several chemicals available for disinfecting them, including Alcavis 100, for disinfection of the dialysis machines and clinic fluid path.
A newer product is the Alcavis Bleach Wipe. Available in a 1:100 dilution for wiping down the surface of dialysis machines and dialysis chairs, the product also comes in a double pack that has two towels, one for the machine and a separate one for the dialysis chair, conforming with clinic policies and procedures. We also offer an EPA Tuberculocidal bleach wipe at a 1:10 dilution of household bleach, Mishkin continues. This is ideal for blood spills and high risk areas.
Bleach is the most regularly used external surface disinfectant at 1 percent concentration, says Chris Gustilo, marketing manager for Minntech Renal Systems. It is used on patient chairs, dialysis machine surfaces including touch screens, scales, counters, etc. Ten percent bleach is also used, but generally only for blood spills.
Certain products are specific to infection control in the dialysis market. These can include coated CVCs, antibacterial soaps for pre-cannulation cleaning by the patient, well-fitting visors, clothing barriers, sharps containers that prevent regurgitation stick injuries, retractable fistulae needles, medication needles and syringes, single use medication vials, says Padovan.
Dialyzer reuse is practiced in approximately 50 percent of the clinics in the USA, says Gustilo. Renalin 100 (peracetic acid) is the most common disinfectant/sterilant used. Almost all reprocessing is done on automated systems, such as the Renatron II Dialyzer Reprocessing System. For fistulas, safety fistula needles are increasingly used. The most common devices are made by Nipro, Medisystems and JMS. For antiseptics, chlorhexidine is used very sparingly. ExSept Plus is used for some catheters. The most commonly used disinfectants remain alcohol and PVP iodine. For a post-treatment hemostasis device, a variety of access site holders have been developed. One of the newer ones uses a Super Stopper with a fistula clamp and an ultra-grip cover. For blood tubing, the industry is moving towards needleless injection ports to prevent needlestick injuries. Also, dialysis centers are looking at reducing the need for transducer protectors to reduce crosscontamination. For the dialysate delivery and water systems, common disinfection methods are heat and chemical (i.e., PAA and bleach). Water systems also use ozone. Regulations continue to move towards more stringent levels of endotoxins and bacteria.
New and innovative products have been added to the market to make the environment safer for both patients and staff. These include an on-demand autodilution system by Minntech; this product is used to prepare dilution solution for disinfectants. Nearly all companies are using heat disinfection for water and delivery systems, Gustilo adds. Safety fistula needles are no longer on the periphery, but are now the norm. And preventing infection with methicillin-resistant Staphylococcus aureus (MRSA) is becoming increasingly front-andcenter because of its impact on patients and their treatment.
How the Manufacturer Can Help
We know the best patient care comes from collaboration between the healthcare providers (nurses, doctors and technicians) and industry to identify the correct products to safeguard the patient, Mishkin muses.
Padovan agrees, adding that sales and clinical specialists can ensure that the customer has a strong knowledge base of the products and services they provide. Written and audio-visual educational materials should be used as an adjunct to on site training. Follow-up and refresher sessions will facilitate compliance with a product and capture new staff turnaround. The CDC and Kidney Disease Outcomes Quality Initiative (KDOQI) Guidelines provide a basis for facilities to practice within the scope of good care. Most of these principles are evidence-based and sound.
Proper training for the use of infection control products is also important, Mishkin adds. For example, there is a wide range of contact times required dependent on the type of antiseptic or disinfectant used. Povidone iodine can take from three to five minutes to be effective. Alcavis products instruct a total of two minutes contact time. The user needs to know the required contact time of the solution they are using to minimize risk of infection. Again, one area of concern is what solution can be used on what type of catheters. Alcohol and alcohol-based products are compatible with silicone, but povidone iodine is not. Conversely, povidone iodine is compatible with polyurethane catheters, but alcohol is not.
Manufacturers and distributors have an increasingly important role in the industry, because they can design and supply tools and chemicals that not only get the job done but also are simple and quick to use, Gustilo points out. Greater patientto- staff ratios and frequent staff turnover means that the tools they use must be easy to learn. And implementing those devices is also a role for them -- because, as Gustilo says, As seen in study after study, the issue many times is not that a product hasnt been identified that will help clinics, but that the adoption of this technology over the long term doesnt happen.
Cost efficacy is another important factor for manufacturers to focus on. Carlson points out that there are always cost issues affecting the dialysis market. The dialysis industry has been under a capitated Medicare payment system for over 20 years for everything except drugs. In real terms, the past 20 years have seen a decrease in reimbursement. This, coupled with the massive consolidation (and concentration), has resulted in a stifling of innovation in the industry. One result of these cost constraints is that the only innovations that are accepted are those that are cost saving over a very short term. While innovations do continue to occur in dialysis, these innovations are happening outside of the United States, where reimbursement is not as constrained, he explains.
Reimbursement specifically is a problem. The current Medicare reimbursement system, Part A and Part B, creates a financial disincentive for dialysis clinics to prevent infections, Carlson adds. Because the dialysis clinic does not get paid to manage the patient, the only consequence when the patient is hospitalized is missed revenue for a dialysis treatment. So if a patient misses three treatment days a year (due to an infection related incident), then the total missed revenue is approximately $900 (or $300 per day). With cost of a treatment around $250, the total profit missed is $150. So, from a simply economic perspective, a dialysis clinic would be willing to spend up to $150 per year on infection control and no more, which works out to approximately $1 per treatment ($150/153 treatments per year). And that $150 would need to mediate all the mechanisms of infections.
Staff/patient ratios are another issue. If you visited dialysis units 20 years ago, the staff-topatient ratios stood at one licensed staff member (RN or LPN) to two or three patients. Today, much of the staff is unlicensed and uncertified, and often there is only one licensed staff working the treatment floor on any one shift. The common staff-to-patient ratio presently stands at one caregiver to four patients, Carlson continues.
And turnover of shifts is a further problem. A dialysis clinic will have between three to five shifts of patients a day. Patients are treated for a four-hour period. The turnover between taking a patient off and getting the next patient started is approximately 30 minutes. In this 30-minute period, the following steps need to occur: (1) outgoing patient stabilized, (2) area cleaned and disinfected, (3) dialysis delivery system set up and readied for next patient, and (4) next patient seated.
If the staff-to-patient ratio is so limited, fitting all of those steps between patients may be a challenge. Some of the required routines in each step may be shortchanged.
And with staff turnover as an additional challenge overall turnover especially with unlicensed and uncertified staff is fairly high in dialysis clinics there is a constant burden of education on the staff with regards to infection control practices, Carlson adds.
By teaming up with manufacturers and suppliers, dialysis providers can ensure that they are giving their best efforts to comfort and care for their patients, to making their stay at the centers as quick and trouble-free as possible, and to ensuring that costs dont negate the staff education and infection control that are so crucial to the patients they treat every day.