Infection Prevention and the Medical Director: Uncharted Territory : Clinical Journal of the American Society of Nephrology

Journal Logo

Role of the Medical Director

Infection Prevention and the Medical Director

Uncharted Territory

Kapoian, Toros*,†; Meyer, Klemens B.‡,§; Johnson, Douglas S.

Author Information
Clinical Journal of the American Society of Nephrology 10(5):p 863-874, May 2015. | DOI: 10.2215/CJN.06050614
  • Free
  • SDC



Health care–associated infections are among the most important preventable causes of dialysis morbidity and mortality (1). Among patients undergoing hemodialysis, hospitalizations for infection have increased 43% since 1993, although the overall hospitalization rate and total hospital days have declined (2). Mortality due to infection peaks in the second month after starting dialysis, at 43 deaths/1000 patient-years, and falls to 19.4 deaths/1000 patient-years after 1 year (2). Since 2000, prevalent hemodialysis (HD) patient mortality rates have declined by 21%. Nonetheless, only half of all patients who begin HD are still living 3 years later (2), and infections cause or contribute to many of these deaths.

Medical Directors: Responsibilities and Importance as Role Models

The dialysis community and dialysis facility medical directors must do better. According to the Centers for Medicare & Medicaid Services (CMS) 2008 Conditions for Coverage (CfC) §494.150 Condition: Responsibilities of the Medical Director, “the dialysis facility must have a medical director … to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients” (3). Table 1 outlines the responsibilities set forth in the CfC.

Table 1:
Centers for Medicare & Medicaid Services Conditions for Coverage § 494.150 Condition: Responsibilities of the Medical Director

To optimize an infection prevention program, dialysis facilities must change their culture. Culture change requires dedicated and committed leadership, which the medical director must provide. This is not an easy task, especially in light of the many other priorities competing for medical directors’ time. To do this well, medical directors need to make infection prevention a priority. They must ensure that their dialysis providers set up evidence-based quality assessment and performance improvement (QAPI) systems and must lead the team, not only attend the QAPI meetings. Medical directors are uniquely positioned to guide and support the dialysis clinic's infection prevention team. Their understanding of epidemiology, microbiology, and pathophysiology, and their professional authority, carry with them the responsibility to champion this quality improvement activity. They need to be involved at every level: educating patients and staff, evaluating adherence to policies and procedures, ensuring that the QAPI process is optimized according to the needs of their clinic, and working with their local administrator and their dialysis provider to ensure that appropriate resources are available to run their program.

Medical directors can think about infection prevention principles in two broad program areas: those regarding patient care and those regarding the facility and its staff. Patient-related issues include those involving the HD access (minimizing the use of catheters, using the Centers for Disease Control and Prevention [CDC] “scrub the hub” protocol, and caring for the arteriovenous access) and immunization issues (screening and vaccination). Dialysis clinic–related issues include hand hygiene, environmental disinfection, cleaning and disinfection of dialysis equipment, modified contact precautions, isolating and cohorting patients, and antibiotic stewardship. This review contains data elements and tools that we have found to be effective. We hope that other medical directors will similarly benefit and use this information to drive the infection prevention process effectively and influence their dialysis providers to adopt programs that have been shown to improve care.

Patient-Related Issues

Hemodialysis Access

Minimize Use of Dialysis Catheters.

Cuffed and noncuffed catheters are 15 and 21 times more likely to become infected, respectively, than arteriovenous fistulae (4). In 2011, 81% of incident patients began HD using a catheter (1). Although patients who had been under the care of a nephrologist for more than a year were more likely to begin treatment using a fistula, 41% still start hemodialysis using a catheter only (2). The prognosis of patients with CKD stage 4 and early stage 5 is uncertain; many die before reaching dialysis, and these numbers may grow in the wake of the Initiating Dialysis Early and Late (IDEAL) study and supporting observational data (5). Nonetheless, medical directors and staff nephrologists alike have an infection prevention opportunity to improve their own practice in preparing patients for dialysis, along with a public health opportunity in educating internists, family practitioners and the other subspecialists with whom they work. Predictive instruments are available to estimate the likelihood that a patient will survive to dialysis (6). Patients should be educated about their dialysis access and what they can do to avoid infections (CDC's "Dialysis Patient Pocket Guide") (7).

Perhaps the most important process to decrease the risk of catheter-related infections is to have a system in place to have permanent accesses placed as soon as possible and to have catheters removed as quickly as possible. Incident patients beginning HD with catheters should be closely monitored and counseled about their risks. Medical directors should ensure that their dialysis clinic staff assists these patients with the necessary steps (e.g., vessel mapping, access surgery appointments) to have a permanent access inserted and catheter removed. Medical directors must also ensure that the dialysis clinic has systems in place to track dialysis catheter infections. One such tool is the Fistula First infection tracking log (8). Medical directors must also ensure that the steps required for catheter removal are followed systematically (Figure 1) (9,10). Given their overwhelmingly high rates of infection, noncuffed catheters should be avoided.

Figure 1:
Example of a dialysis catheter removal tracking tool. Adapted from references 9 , 10.

Implement the CDC “Scrub the Hub” Protocol.

The CDC recommends using a “scrub the hub” protocol as a method to reduce the likelihood of bloodstream infection in patients receiving HD via a central venous catheter (11). The procedure involves using one of several acceptable antiseptics, including >0.5% chlorhexidine gluconate (CHG) with alcohol, 70% alcohol, or 10% povidone-iodine. After application, the solution should be allowed to dry completely to impart maximal effect. The effect might be enhanced if an antiseptic pad is used rather than a swab or other delivery system because a pad can conform to the surface irregularities of the catheter. Particular attention should be paid to the catheter hub and its connecting limb, both of which are “scrubbed” starting at the catheter hub (with caps removed) and ensuring that the threads are cleaned of any residual debris or blood. The scrubbing action then continues to move along the catheter limb in a direction toward the patient and away from the open threaded end of the hub. If vascular access related infection or the blood stream infection rates are unacceptably high, medical directors should review clinic policies and practice and recommend changes as indicated.

Care of the Fistula or Graft and Skin Preparation for Dialysis.

Patients should learn the CDC’s "6 Tips for Preventing Dialysis Infections" (Supplemental Material): (1) Take care of your dialysis access site at home. Avoid scratching or picking it; (2) know the steps your health care providers should take when using your dialysis access for treatment; (3) wash your hands often, especially before and after dialysis treatment; (4) know the signs and symptoms of infection and what to do if you think you might have an infection; (5) know what to do if you have any problem with your dialysis access site; (6) wash or cleanse your dialysis access site before treatment (7). The importance of patient hand and arm washing deserves continuing emphasis (12).

The skin overlying a fistula or graft may be prepared for cannulation using povidone iodine, CHG, sodium hypochlorite, or alcohol. Table 2 compares their characteristics (1319). The CDC recommends using “an alcohol-based chlorhexidine (>0.5%) solution as the first line skin antiseptic agent for central line insertion and during dressing changes” (18). Some studies suggest that CHG is more effective than other agents (2025), but this finding is not definitive; the choice of agent is less important than strict adherence to the procedure of its application (20). CHG is particularly attractive in the dialysis setting because it dries so quickly. CHG may be used for skin preparation before catheter insertion, during catheter exit site care, and during catheter limb/hub care. Unfortunately, many patients and facilities limit its use because of adverse reactions ascribed to CHG. The rate of true allergic reactions to CHG is <5% (26,27). If facilities experience higher rates, episodes of generalized skin irritation are probably being classified as true allergic reactions (see Table 3) (28). In patients suspected of having a reaction to CHG, rechallenge with CHG on a nonaccess site may be warranted. Medical directors need to know how vascular accesses are managed in their clinics. They should review the choice of topical disinfectant, design a protocol for skin disinfection that adheres to guidelines, ensure that patients are not experiencing an increased incidence of adverse events, and ensure that patients and dialysis staff are following policy. Any areas of concern should be reviewed and addressed in QAPI.

Table 2:
Comparison of topical skin disinfectants available for use in dialysis
Table 3:
Possible causes of chlorhexidine-associated skin irritation

Immunization and Screening Issues

Routine Screening.

The CMS 2008 CfC adopt the CDC 2001 recommendations regarding screening for hepatitis B virus (HBV) infection and immunity. Following these recommendations, individual by individual, for a large population of patients is a complex enterprise. Medical directors should consider developing a program of regular audits and review these finding in QAPI. HBV surface antigen may occasionally appear as a false-positive test result following influenza and hepatitis B immunizations (29,30). Testing for HBV surface antigen within 4 weeks of immunization for hepatitis B increases the risk for a false-positive result (31). The presence of rheumatoid factor may produce false-negative results (32,33). The availability of nucleic acid testing may be helpful in selected cases but may also create further uncertainty (34).

HBV seroconversions, a major problem in the early 1970s, have become a rare event in dialysis facilities, but hepatitis C virus (HCV) transmission remains an important problem. The CDC 2001 recommendations included screening for HCV antibody every 6 months in patients lacking antibody and thus free of infection. Notably, CMS did not adopt hepatitis C screening in the 2008 CfC, giving the dialysis medical directors and governing bodies a choice of what approach to adopt. If a policy of less than universal screening is adopted, it may be prudent to consider the CDC’s more recent recommendation for universal screening among individuals born between 1945 and 1965. Whatever level of screening for hepatitis C is adopted, it is prudent also to include universal testing of alanine aminotransferase in monthly blood work and to investigate unexplained elevations. Both HBV and HCV are reportable, and seroconversions should also prompt a thorough internal root cause analysis (35).

Although the 2008 CfC do not speak to screening for tuberculosis (TB), the interpretive guidelines for surveyors require that dialysis facilities record the history of tuberculosis testing; page 190 of the Interpretive Guidance column of the document quotes a CDC recommendation that dialysis patients “[b]e tested at least once for baseline tuberculin skin test (TST) results and re-screened if TB exposure is detected. Chest x-rays may be used for individuals for whom the TST is not an option” (36). IFN-γ release assays have sensitivities similar to that of TSTs (37) and may be better than chest radiography. Although their optimal role in a TB prevention strategy has not been established, they can be used as an adjunct to TST in certain circumstances, such as in patients or employees who have previously been treated with bacillus Calmette–Guérin (38). Because dialysis patients are at increased risk for progression of latent infection to active TB, their identification is an important part of targeted testing for TB infection and treatment. According to the CDC, “patients with ESRD who need chronic dialysis should have at least one test for M. tuberculosis infection to determine the need for treatment. Annual re-screening is indicated if ongoing exposure of ESRD patients to M. tuberculosis is probable” (39). Medical directors should review their clinic’s TB infection control program annually. The CDC’s TB risk assessment worksheet (40) is a helpful tool.


HBV vaccination is recommended for all susceptible patients undergoing long-term dialysis. In general, vaccinating patients with CKD before dialysis initiation produces higher antibody titers and seroprotection rates than vaccinating patients who have already begun dialysis (41). Vaccination, coupled with environmental controls, is the best method for preventing the spread of HBV within the dialysis clinic. Medical directors must ensure that their clinics have programs in place to monitor the administration of hepatitis B vaccine to all patients. Figure 2 is an example of a hepatitis B tracking form. These results should be reviewed in QAPI. Medical directors must also ensure that the clinic does not assign staff who are susceptible to HBV infection to care for patients who are HBV surface antigen positive. Furthermore, a nurse or technician participating in the treatment of a HBV surface antigen–positive patient cannot provide simultaneous care to patients who do not have adequate titers (>10 international units) of HBV surface antibody. Medical directors should spot-check staff assignments to ensure that these rules are being followed. Special attention should be given to the temporary staffing coverage that occurs during meal and shift breaks when these rules may be more likely to be violated. The sensitivity of available HBV surface antigen assays is increasing, and it may behoove medical directors to ask their laboratory which assay it uses (42).

Figure 2:
Example of a hepatitis B vaccination tracking form used in some Dialysis Clinic, Inc. clinics.

Routine annual influenza vaccination is recommended for all persons aged 6 months and older. Until recently, all patients received a trivalent vaccine that was designed to protect against two strains of influenza A and one strain of influenza B. Epidemics of influenza B occur every several years in patients of all ages and are much more difficult to predict than influenza A strains. In 2013 a quadrivalent influenza vaccine containing two strains of influenza A and two strains of influenza B was made available (43). It is hoped that the newer quadrivalent products will provide additional influenza protection. Older adults have decreased antibody response to influenza vaccination (44). Studies performed in patients aged 65 years and older have shown that high-dose vaccines containing four times the standard amount of antigen elicited a substantially higher immune response (4547). Although no controlled trials have assessed these vaccines in the HD population, newer formulations (quadrivalent and high-dose) can be considered for use in the HD population. Although vaccine effectiveness varies from year to year, depending on the match between the vaccine strains and the strains that turn out to be prevalent, it is reasonable to estimate that vaccination may reduce the risk of death from influenza by 50% (4850). Patients may casually decline vaccination without fully understanding its small risks and substantial benefits. Because vaccination is performed on behalf not only of the individual being immunized but also the public, it is appropriate for medical directors to personally speak with any patients who have declined vaccine to try to persuade them to change their minds.

By the very nature of their work, health care workers (HCWs) are at increased risk for contracting influenza and for transmitting it to their dialysis patients, a group at high risk for morbidity and mortality from influenza. Although some voluntary HCW vaccination programs have achieved sufficiently high vaccination rates, there is now a trend toward mandating universal influenza vaccination of HCWs, with individuals who are not able to receive the vaccine because of medical contraindications or who decline vaccination being required to wear masks while working with patients during the influenza season. This movement is supported by many professional societies, including the American College of Immunization Practices (ACIP), the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the Pediatric Infectious Diseases Society, and others. According to the CDC, only 72% of HCWs reported being vaccinated against influenza for the 2012–2013 season (51). Although this represents an increase from the previous year (67%), it is far lower than rates seen for physicians (92%) or HCWs (97%) in settings with mandatory vaccination requirements. In view of the fragility of dialysis patients, medical directors should consider universal influenza vaccination; the fact that an increasing number of major medical centers require this of their employees may make it more acceptable. Medical directors should consider whether patients who decline or are unable to receive vaccination should also be subject to the requirement to wear a mask during influenza season.

Streptococcus pneumoniae (pneumococcus) is a leading cause of serious illness in adults. Adults with high-risk medical conditions are at increased risk for invasive pneumococcal disease. The ACIP now recommends that dialysis patients be vaccinated with both the PPSV23 vaccine (Pneumovax, traditionally used in adults) as well as the PCV13 vaccine (traditionally used in children, marketed as Prevnar) (52). This recommendation comes from 2010 data showing that half of the cases of invasive pneumococcal disease among immunocompromised adults were caused by pneumococcal serotypes contained in the PCV13 vaccine and another almost quarter of the cases were caused by serotypes contained in the PPSV23 vaccine. In pneumococcal vaccine–naive patients, ACIP recommends that adults aged 19 years and older who have not previously received PCV13 or PPSV23 should receive a dose of PCV13 first, followed by a dose of PPSV23 at least 8 weeks later. Subsequent doses of PPSV23 should follow the current PPSV23 recommendations. In patients who were previously vaccinated with PPSV23, ACIP recommends that adults aged 19 years and older should be vaccinated with PCV13 at least 1 year after the last PPSV23 dose was received. For those who require additional doses of PPSV23, the first such dose should be given no sooner than 8 weeks after PCV13 and at least 5 years after the most recent dose of PPSV23. Medical directors should review the clinic’s policies regarding pneumococcal vaccination to see whether they have been modified according to ACIP recommendations.

Dialysis Clinic–Specific Issues

Hand Hygiene

Hand hygiene is the cornerstone of infection prevention. Medical directors must ensure the proper use of hand-washing sinks and waterless hand sanitizers, by setting an example, publically asking other physicians and staff to comply, and requiring random audits of staff adherence to appropriate hand hygiene opportunities (Table 4) (53,54). Proper use of soap, paper towels, and hand sanitizer should be audited regularly. Examples of audit tools are available from the World Health Organization (55) and the CDC (56). Results of these audits should be reviewed at the monthly clinic QAPI meeting. As clinic leaders, it is essential that medical directors clean their hands before and after contact with each patient, and work to ensure that other nephrologists in the clinic follow suit (57,58). They should insist that policies and procedures require that when the patient is suspected or documented to have Clostridium difficile infection, soap and water must be used at all times (59): alcohol-based hand-sanitizers do not kill the spores (60,61). Hand washing is not trivial: staff must demonstrate proper methods for hand washing and use of waterless hand sanitizer. The World Health Organization's "Hand Hygiene: Why, How & When?" brochure (62) is a helpful resource.

Table 4:
Hand hygiene opportunities in dialysis

HCWs must wear gloves and other personal protective equipment (PPE) (see the CDC "Sequence for Donning and Removing Personal Protective Equipment" poster [63]) when engaged in any activity that may result in contact with blood or body fluids (Table 5) (53). If staff cannot properly perform hand hygiene or use PPE, medical directors must ensure that programs are put in place to correct these issues. Assuring hand-cleaning competence or PPE use could be appropriate quality improvement projects.

Table 5:
Association for Professionals in Infection Control and Epidemiology recommendations for personal protective equipment use during hemodialysis procedures

Environmental Disinfection

Proper cleaning and disinfection reduce the risk of spreading infections. Cleaning involves the use of water, a detergent, and friction to remove surface dirt and protein-containing materials and to prepare the surface for disinfection. Disinfection reduces the number of microorganisms and is optimized when applied to a clean surface. Surfaces that are not cleaned allow microorganisms to “hide” from the disinfectant within the layers of dirt and protein. Medical directors should ensure that the clinic is using an Environmental Protection Agency–registered hospital-grade disinfectant (64) and following the manufacturer's instructions for dilution and contact time (65). To prevent contamination of the stock solution, the solution should be changed frequently, and used disinfection cloths should not be submerged in the solution. Bleach is the most commonly used disinfectant in dialysis units. If bleach is being used, medical directors should ensure that it is Environmental Protection Agency–registered hospital-grade bleach (65). They should also ensure that their clinic correctly prepares the diluted solution and that each batch is dated and timed.

Particular attention should be paid to high-touch areas and all aspects of the dialysis station, including BP cuffs, television controls and remote control devices, machine surfaces, dialysate waste buckets, intravenous poles, and other surfaces where patients store personal belongings. The CDC's "Checklist: Dialysis Station Routine Disinfection" (66) can help medical directors and their clinics organize this process. Any visible soil must be cleaned before disinfection. Medical directors should ensure that sufficient disinfectant be applied to environmental surfaces with sufficient contact time. The dialysis chair may be difficult to clean adequately. Torn or damaged surfaces should be repaired immediately. All surfaces, including the crevices between the sides and back of the chair, should be adequately cleaned and disinfected. Dialysis chairs should be thoroughly cleaned to remove debris that may be caught in the seams and crevices. They should not be power-washed. All devices for which the manufacturer makes recommendations about cleaning must be cleaned in accordance with those recommendations. Medical directors should periodically observe staff practice during turnover. Dialysis staff should wait for the previous patient to exit the dialysis station before they begin cleaning and disinfecting for the next patient.

If medical directors are involved in the construction of a dialysis clinic, they should ensure that the chosen surfaces are smooth, nonporous, easy to clean, and compatible with hospital-grade cleaners and disinfectants. A cleaning schedule is needed for all items and areas. Medical directors should periodically walk through and inspect the clinic. They should ensure that any worn, stained, torn, or cracked items are replaced. Cloth furnishings and carpeting are not recommended in patient care areas, and if these are chosen, medical directors should ensure that the clinic has a process to keep these items clean and maintained.

Dialysis Equipment

Nondisposable equipment used in the dialysis clinic must be disinfected according to the manufacturer’s directions for use. These include dialysis machines, water treatment and distribution systems, acid and bicarbonate jugs, mixing and distributing systems, dialyzers and dialyzer reprocessing equipment, oxygen tanks and oxygen concentrators, centrifuges, pipettes and other laboratory equipment, BP cuffs, stethoscopes, and vascular clamps. Equipment differs between manufacturers. For example, some dialysis machines have a waste handling option, while other have a priming bucket. Each requires different procedures to prevent the spread of potentially infectious material. Nondisposable items that are taken into a patient’s HD station must be dedicated for single-patient use or disinfected before being used on another patient. Items that cannot be disinfected should be dedicated for single-patient use (53).

The Association for the Advancement of Medical Instrumentation (AAMI) standards state that dialysis water samples must be collected throughout the distribution loop, including where the water enters a mixing tank, where a dialysis machine connects to the water distribution loop, and from a point in the distal segment of the loop. Samples must be assayed within 4 hours of collection or immediately refrigerated. Samples must be sent for culture and endotoxin with water treatment disinfection conducted if an action level is exceeded. Although the AAMI standards were revised in 2009, the CMS 2008 CfC only require dialysis facilities to comply with the 2006 standards (67,68) (Table 6). Ultrapure dialysis fluid, not required by regulation, requires a dialysate total viable microbial count <0.1 colony-forming units/ml and endotoxin levels less than 0.03 EU/ml (67). Medical directors should review and sign (as evidence that they have reviewed) their clinic’s culture and endotoxin results during QAPI. These data should be examined for trends, with corrective action plans initiated as appropriate.

Table 6:
AAMI recommendations for water and dialysate

Modified Contact Precautions

Multidrug-resistant organisms (MDROs) are microorganisms, usually bacteria, that are resistant to one or more classes of antimicrobial agents (Table 7) (69). These pathogens can be gram-positive (such as resistant Staphylococcus aureus), gram-negative (such as β-lactamase–producing Pseudomonas aeruginosa), or fungal (resistant Candida species). Patients who are colonized or infected with an MDRO require special attention to prevent the spread of these microorganisms to others. The first case of methicillin-resistant S. aureus (MRSA) was identified in the United Kingdom in 1961 (70). Since then, controlling the spread of MRSA has become a health care priority. This is especially true in dialysis patients, whose rate of invasive MRSA infections is 100 times higher than that in the general population (71). The major determinant of the rise in MDROs is patient-to-patient transmission, usually by HCW hands. Unlike hospitals or other skilled nursing facilities, most dialysis units do not have the ability to isolate these patients. Given these constraints, additional precautions for patients at increased risk for transmitting infection are warranted. These “modified contact precautions” (Table 8) include use of a dedicated gown over clothing in caring for patients with MDRO infections and removal of this gown when finished (72). Patients with MDROs should be dialyzed at an end-station or in the corner of the dialysis unit to minimize the number of adjacent stations. Medical directors should be aware of all patients with MDRO infections who are undergoing dialysis. They should consider the use of these modified contact precautions if the rates of MDRO infections in their clinic are unacceptably high.

Table 7:
Centers for Disease Control and Prevention antibiotic resistance threats in the United States
Table 8:
Modified contact precautions

Isolating and Cohorting Patients

The only patients whom regulation requires that dialysis facilities treat in isolation are those who test positive for the HBV surface antigen. Dialysis nurses and technicians treating these patients may not at the same time treat a susceptible patient, one who lacks surface antibody. Incident patients who have not yet been shown, by a recent result, to test negative should be isolated using the same policies and procedures—such as dedicated equipment, dedicated gowns for staff, terminal disinfection of the dialysis machine after treatment—but not receive dialysis in the HBV isolation room. Given the low prevalence of HBV surface antigen positivity, the incident patient is statistically more likely to be surface antigen negative, and administering dialysis to them in the HBV isolation room puts them at risk of acquiring HBV infection. In the absence of an adequate titer of HBV surface antibody, it is logical to require a negative HBV surface antigen result within the past 30 days in prevalent patients. In the presence of a documented history of adequate antibody titers, it might seem reasonable to accept an incident patient who had an older negative antigen result drawn more than 30 days earlier. However, the CDC “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients” states: “among hemodialysis patients who respond to the vaccine, protection against HBV is not maintained when antibody titers fall below protective levels” (73). Therefore, medical directors who wish that their clinic accept an incident patient lacking adequate antibody titers and a negative hepatitis B surface antigen result within the past month should personally review the serologic data or should order isolation until new results are available.

Dialysis clinics that were built before February 9, 2009, or have been granted a waiver may have an isolation “area” rather than isolation “room.” In such cases, the ESRD Program Interpretative Guidance states that the “area used for HBV surface antigen positive patients must be separated from other stations by a space equivalent to the width of one hemodialysis station” (74). In clinics with an isolation area, medical directors should strongly encourage their dialysis provider to create an isolation room, which is the better method for managing patients with HBV surface antigen.

Experience in facilities having a high prevalence of HCV shows that cohorting or isolation of patients with HCV is associated with a reduction in seroconversions of susceptible patients (7577). It is not known whether the effect would be similar in a clinic that carefully observes all CDC recommendations for infection prevention. In any event, no United States authority has recommended isolation or cohorting of HCV-positive patients. Medical directors should review all newly identified cases of HBV and HCV infection and consider whether evidence shows a breach in infection prevention practice.

As noted above, patients with MDROs as well as those infected with or suspected of having C. difficile should undergo dialysis at an end-station or in the corner of the dialysis unit to minimize the number of adjacent stations.

Antibiotic Stewardship

The rising prevalence of MRSA has been accompanied by the increased use of vancomycin. The pharmacokinetic profile of vancomycin has made it the antibiotic of choice for suspected gram-positive bacterial infections in the dialysis population. Unfortunately, the common and often indiscriminant use of vancomycin has led to resistance. In 1997, the CDC reported the first S. aureus strains exhibiting reduced susceptibility to vancomycin. These vancomycin-intermediate S. aureus specimens were isolated from peritoneal dialysis patients in Michigan and New Jersey (78). In 2002, the first case of vancomycin-resistant S. aureus was identified in an HD patient (79). That same year the CDC launched its "Campaign to Prevent Antimicrobial Resistance." This initiative focuses on the use of narrow-spectrum yet effective antimicrobial treatment of documented infections by identifying the organism and susceptibilities to optimally target treatment and limiting use of broad-spectrum antimicrobials.

Medical directors should ensure that processes are in place to track microbiologic culture results, resistant organisms, and antibiotic administration. Most laboratories that process microbiologic samples routinely perform antimicrobial susceptibility testing for bacterial pathogens, and aggregate these cumulative susceptibility testing results into a summary table, or antibiogram (Figure 3). The antibiogram can be used as the community reference guide to determine local microorganism resistance patterns. A member of the dialysis unit infection prevention team should collaborate with the local laboratory to regularly update the antibiogram. Medical directors should review the dialysis unit’s culture results, patterns of antimicrobial resistance, use of empirical antimicrobial agents, and the appropriateness of antimicrobial administration.

Figure 3:
Sample antibiogram. Numbers represent the percentage of isolates susceptible to the specified antibiotic. VRE, vancomycin-resistant Enterococcus; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-sensitive Staphylococcus aureus.

Putting It All Together

Creating an Infection Prevention Program

Establishing an infection prevention committee is the first step in preventing the spread of infection within a dialysis unit. This review and the referenced audit tools should provide the elements to start a comprehensive infection prevention program. Many of the items may be familiar to medical directors but not to other members of the infection prevention team. At a minimum, this committee should include the medical director (serving as its leader), the nurse manager of the dialysis clinic, and a member of the biomedical department. The committee should develop and review policies as well as monitor the dialysis clinic for infections and practice patterns that might lead to the spread of infection.

The first task of the infection prevention committee should be to conduct a generalized infection prevention audit using a tool such as is provided by the CDC (80). This audit will highlight the areas of concern within the dialysis unit. The CMS Surveyor Laminate on infection control and isolation offers another point of departure (81). Any of the elements listed in the patient-specific and dialysis clinic–specific areas, such as hand hygiene and review of dialysis charts for vaccination records, can be appropriate audits performed by the infection prevention committee. These audits and the findings of the infection prevention committee should be presented at the dialysis clinic's QAPI meetings (Table 9) and to the governing authority (82). Although not mandated, the medical director may find it helpful to engage the services of a consultant infection preventionist. The expertise of these professionals in infection control and prevention can be invaluable. A collaborative relationship can help medical directors determine the status of their dialysis clinic and optimize their infection prevention program.

Table 9:
Centers for Medicare & Medicaid Conditions for Coverage quality assessment and performance improvement requirements


Health care–associated infections are a common yet preventable cause of dialysis morbidity and mortality. Medical directors are key leaders in infection prevention and are an important resource to implement programs to monitor and improve infection prevention practices at all levels within the dialysis clinic. Medical directors should help develop and review protocols guiding practice for tasks such as the care of patients with MDRO infections and universal vaccination to help avoid preventable health care–associated infections. They should also institute policies regarding hand hygiene, environmental and dialysis equipment disinfection, and other processes of care that will allow the clinic to optimize care for their dialysis patients.

More important, medical directors serve as role models both to clinic staff and to other health care practitioners. Medical directors must set the policy standards and lead by example. They are under the scrutiny of patients, colleagues, and dialysis staff who see whether they wash their hands, wear gloves, and disinfect their stethoscopes between patients. How can medical directors expect their patients to wash their access with soap and water before cannulation, sanitize their hands after holding their sites at the end of treatment, or consent to influenza vaccination if they and other practitioners are not following the rules themselves? Medical directors should send a consistent message to the entire dialysis community, including other practitioners, that these elements are not trivial. When other nephrologists or healthcare practitioners do not follow policies, it is the medical director who must let them know, firmly but respectfully, that this behavior will not be tolerated in the dialysis clinic. Medical directors are entrusted with the lives of all the patients that dialyze in their clinics and must protect all of them at all times.


The opinions or views expressed in this manuscript are those of the authors and do not necessarily reflect the opinions of Dialysis Clinic, Inc.


D.J. is the Vice Chairman of the Board for Dialysis Clinic, Inc. T.K. is an employee of Dialysis Clinic, Inc. K.M. receives salary support from Dialysis Clinic, Inc.

Published online ahead of print. Publication date available at

This article contains supplemental material online at


1. Patel PR, ed: Understanding and preventing infectious complications in dialysis. Semin Dial 26: 375–530, 2013
2. U.S. Renal Data System: USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2013
3. Centers for Medicare & Medicaid Services: 42 CFR Parts 405, 410, 413. Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule. Federal Register Available at: Accessed July 12, 2014
4. Tokars JI, Miller ER, Stein G: New national surveillance system for hemodialysis-associated infections: initial results. Am J Infect Control 30: 288–295, 2002
5. Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CAIDEAL Study: A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med 363: 609–619, 2010
6. Tangri N, Stevens LA, Griffith J, Tighiouart H, Djurdjev O, Naimark D, Levin A, Levey AS: A predictive model for progression of chronic kidney disease to kidney failure. JAMA 305: 1553–1559, 2011
7. Centers for Disease Control and Prevention: Dialysis patient pocket guide. Available at: Accessed April 4, 2014
8. Change Concept 9: Infection tracking log. Available at: Accessed December 26, 2014
9. FFBI Monitoring the newly placed AV fistula for maturation algorithm. Available at: Accessed December 26, 2014
10. Change Concept 7: Central venous catheter tracking tool. Available at: Accessed December 26, 2014
11. Centers for Disease Control and Prevention: Central venous catheter hub cleaning prior to accessing. 2009. Available at: Accessed April 2, 2014
12. Walworth L; ESRD Network of New England. Dialysis patients speak preventing infections 2012. Available at: Accessed May 28, 2014
13. ChloraPrep product label. El Paso, TX, CareFusion, April 2013
14. National Kidney Foundation: KDOQI clinical practice guidelines and clinical practice recommendations for 2006 updates: Hemodialysis adequacy, peritoneal dialysis adequacy and vascular access. Am J Kidney Disease 48(suppl 1): S1–S322, 2006.
    15. Hemani ML, Lepor H: Skin preparation for the prevention of surgical site infection: Which agent is best? Rev Urol 11: 190–195, 2009
    16. Moureau NL, Dawson RB: Keeping needleless connectors clean, part 1. Nursing 40: 18–19, 2010
    17. ExSept Plus product information. Gaithersburg, MD, Angelini Pharma, Inc., October 2014
      18. Centers for Disease Control and Prevention: CDC approach to BSI prevention in dialysis facilities (i.e., the core interventions for dialysis bloodstream infection [BSI] prevention). Available at: Accessed July 23, 2014
      19. Alcavis 50 product information. Gaithersburg, MD, Angelini Pharma, Inc, June 2014
      20. Centers for Disease Control and Prevention: Guidelines for the prevention of intravascular catheter-related infections, 2011. Available at: Accessed May 28, 2014
      21. Onder AM, Chandar J, Billings A, Diaz R, Francoeur D, Abitbol C, Zilleruelo G: Chlorhexidine-based antiseptic solutions effectively reduce catheter-related bacteremia. Pediatr Nephrol 24: 1741–1747, 2009
      22. Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH: Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med 362: 18–26, 2010
      23. Vallés J, Fernández I, Alcaraz D, Chacón E, Cazorla A, Canals M, Mariscal D, Fontanals D, Morón A: Prospective randomized trial of 3 antiseptic solutions for prevention of catheter colonization in an intensive care unit for adult patients. Infect Control Hosp Epidemiol 29: 847–853, 2008
      24. Mimoz O, Villeminey S, Ragot S, Dahyot-Fizelier C, Laksiri L, Petitpas F, Debaene B: Chlorhexidine-based antiseptic solution vs alcohol-based povidone-iodine for central venous catheter care. Arch Intern Med 167: 2066–2072, 2007
      25. O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint SHealthcare Infection Control Practices Advisory Committee (HICPAC): Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis 52: e162–e193, 2011
      26. Garvey LH, Krøigaard M, Poulsen LK, Skov PS, Mosbech H, Venemalm L, Degerbeck F, Husum B: IgE-mediated allergy to chlorhexidine. J Allergy Clin Immunol 120: 409–415, 2007
      27. Beaudouin E, Kanny G, Morisset M, Renaudin JM, Mertes M, Laxenaire MC, Mouton C, Jacson F, Moneret-Vautrin DA: Immediate hypersensitivity to chlorhexidine: Literature review. Eur Ann Allergy Clin Immunol 36: 123–126, 2004
      28. Kallen AJ, Patel PR, Hess S: Intolerance of chlorhexidine as a skin antiseptic in patients undergoing hemodialysis. Infect Control Hosp Epidemiol 32: 1144–1146, 2011
      29. Bigham M, Ponnampalam A: Neutralization positive but apparent false-positive hepatitis B surface antigen in a blood donor following influenza vaccination. Transfus Apheresis Sci 50: 92–94, 2014
      30. Schwarzwald H, Kline NE: False positive hepatitis B surface antigen test caused by hepatitis B vaccine. Pediatr Infect Dis J 20: 1101–1102, 2001
      31. Onuigbo MA, Nesbit A, Weisenbeck J, Hurlburt J: Hepatitis B surface antigenemia following recombinant Engerix B hepatitis B vaccine in an 81-year-old ESRD patient on hemodialysis. Ren Fail 32: 531–532, 2010
      32. Xu L, Yu Z, Fan W, Wang X, Xie M, Xu Y, Hu L, Li Y: Negative interference in serum HBsAg ELISA from rheumatoid factors. PLoS One 8: e80620, 2013
      33. Xu L, Wang X, Ma R, Zeng X, Wu B, Hu L, Li Y: False decrease of HBsAg S/CO values in serum with high-concentration rheumatoid factors. Clin Biochem 46: 799–804, 2013
      34. Charlewood R, Flanagan P: Ultrio and Ultrio Plus non-discriminating reactives: False reactives or not? Vox Sang 104: 7–11, 2013
      35. Mbaeyi C, Thompson ND: Hepatitis C virus screening and management of seroconversions in hemodialysis facilities. Semin Dial 26: 439–446, 2013
      36. Centers for Medicare &Medicaid Services: ESRD Surveyor Training. Interpretive Guidance. Interim final version 1.1. October 3, 2008. Available at: Accessed May 28, 2014.
      37. Pai M, Zwerling A, Menzies D: Systematic review: T-cell-based assays for the diagnosis of latent tuberculosis infection: an update. Ann Intern Med 149: 177–184, 2008
      38. Mazurek GH, Jereb J, Vernon A, LoBue P, Goldberg S, Castro KIGRA Expert CommitteeCenters for Disease Control and Prevention (CDC): Updated guidelines for using interferon gamma release assays to detect Mycobacterium tuberculosis infection - United States, 2010. MMWR Recomm Rep 59[RR-5]: 1–25, 2010
      39. Jensen PA, Lambert LA, Iademarco MF, Ridzon RCDC: Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Recomm Rep 54[RR-17]: 1–141, 2005
      40. Centers for Disease Control and Prevention: Appendix B: Tuberculosis (TB) risk assessment worksheet. Available at: Accessed July 24, 2014
      41. Fraser GM, Ochana N, Fenyves D, Neumann L, Chazan R, Niv Y, Chaimovitch S: Increasing serum creatinine and age reduce the response to hepatitis B vaccine in renal failure patients. J Hepatol 21: 450–454, 1994
      42. Martin LA, Stramer SL, Kuhns MC, Schlauder GG: Correlation of improved hepatitis B surface antigen detection limits with hepatitis B virus DNA nucleic acid test yield in blood donations. Transfusion 52: 2201–2208, 2012
      43. Centers for Disease Control and Prevention (CDC): Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices—United States, 2013-2014. MMWR Recomm Rep 62[RR-07]: 1–43, 2013
      44. Reber AJ, Chirkova T, Kim JH, Cao W, Biber R, Shay DK, Sambhara S: Immunosenescence and challenges of vaccination against influenza in the aging population. Aging Dis 3: 68–90, 2012
      45. Couch RB, Winokur P, Brady R, Belshe R, Chen WH, Cate TR, Sigurdardottir B, Hoeper A, Graham IL, Edelman R, He F, Nino D, Capellan J, Ruben FL: Safety and immunogenicity of a high dosage trivalent influenza vaccine among elderly subjects. Vaccine 25: 7656–7663, 2007
      46. Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ: Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis 200: 172–180, 2009
      47. Keitel WA, Atmar RL, Cate TR, Petersen NJ, Greenberg SB, Ruben F, Couch RB: Safety of high doses of influenza vaccine and effect on antibody responses in elderly persons. Arch Intern Med 166: 1121–1127, 2006
      48. Simonsen L, Taylor RJ, Viboud C, Miller MA, Jackson LA: Mortality benefits of influenza vaccination in elderly people: an ongoing controversy. Lancet Infect Dis 7: 658–666, 2007
      49. Vu T, Farish S, Jenkins M, Kelly H: A meta-analysis of effectiveness of influenza vaccine in persons aged 65 years and over living in the community. Vaccine 20: 1831–1836, 2002
      50. Gross PA, Hermogenes AW, Sacks HS, Lau J, Levandowski RA: The efficacy of influenza vaccine in elderly persons. A meta-analysis and review of the literature. Ann Intern Med 123: 518–527, 1995
      51. Centers for Disease Control and Prevention: How many health care workers got vaccinated last season? Available at: Accessed April 2, 2014
      52. Centers for Disease Control and Prevention (CDC): Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 61: 816–819, 2012
      53. Association for Professionals in Infection Control and Epidemiology (APIC): Guide to the elimination of infections in hemodialysis. 2010. Available at: Accessed April 7, 2014.
      54. Centers for Disease Control and Prevention: Infection prevention in dialysis settings. June 1, 2012. Available at: Accesssed July 23, 2014.
      55. World Health Organization: Clean care is safer care. Save Lives: Clean Your Hands observation form. August 2009. Available at: Accessed March 26, 2014.
      56. Centers for Disease Control and Prevention: CDC Dialysis Collaborative. Audit tool: hemodialysis hand hygiene observations. Available at: Accessed March 26, 2014
      57. Kowitt B, Jefferson J, Mermel LA: Factors associated with hand hygiene compliance at a tertiary care teaching hospital. Infect Control Hosp Epidemiol 34: 1146–1152, 2013
      58. Szilágyi L, Haidegger T, Lehotsky A, Nagy M, Csonka EA, Sun X, Ooi KL, Fisher D: A large-scale assessment of hand hygiene quality and the effectiveness of the “WHO 6-steps.” BMC Infect Dis 13: 249, 2013
      59. Centers for Disease Control and Prevention: Guide to infection prevention for outpatient settings: Minimum expectations for safe care. Available at: Accessed July 24, 2014
      60. Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MHSociety for Healthcare Epidemiology of AmericaInfectious Diseases Society of America: Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol 31: 431–455, 2010
      61. Wullt M, Odenholt I, Walder M: Activity of three disinfectants and acidified nitrite against Clostridium difficile spores. Infect Control Hosp Epidemiol 24: 765–768, 2003
      62. World Health Organization: Hand hygiene: Why, how & when? August 2009. Available at: Accessed March 26, 2014.
      63. Centers for Disease Control and Prevention: Sequence for donning and removing personal protective equipment (PPE). Available at: Accessed April 4, 2014
      64. Environmental Protection Agency: Selected EPA-registered disinfectants. Available at: Accessed July 24, 2014
      65. Centers for Disease Control and Prevention: Environmental surface disinfection in dialysis facilities: notes for clinical managers. Available at: (Accessed April 2, 2014).
      66. Centers for Disease Control and Prevention: Checklist: Dialysis station routine disinfection. Available at: Accessed April 4, 2014
      67. Association for the Advancement of Medical Instrumentation (AAMI): Water for hemodialysis and related therapies. ANSI/AAMI/ISO 13959. 2009. Available at: Accessed April 7, 2014
      68. Association for the Advancement of Medical Instrumentation (AAMI): Water for hemodialysis and related therapies. ANSI/AAMI RD62. 2006. Available at: Accessed April 7, 2014
      69. U.S. Department of Health and Human Services: Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013. Available at: Accessed July 25, 2014
      70. Chambers HF: The changing epidemiology of Staphylococcus aureus? Emerg Infect Dis 7: 178–182, 2001
      71. Centers for Disease Control and Prevention (CDC): Invasive methicillin-resistant Staphylococcus aureus infections among dialysis patients—United States, 2005. MMWR Morb Mortal Wkly Rep 56: 197–199, 2007
      72. Patel PR: Infection control: New challenges under the new conditions. Presented at Preparing for the New Medical Director Responsibilities meeting, Chicago, IL, October 21, 2008
      73. Centers for Disease Control and Prevention: Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR 50(RR05): 1–43, 2001
      74. Centers for Medicare & Medicaid Services: ESRD interpretative guidance update. October 3, 2008. Available at: Accessed November 18, 2014
      75. Agarwal SK, Dash SC, Gupta S, Pandev RM: Hepatitis C virus infection in haemodialysis: the “no-isolation” policy should not be generalized. Nephron 111: c133–140, 2009.
      76. Harmankaya O, Cetin B, Obek A, Seber E: Low prevalence of hepatitis C virus infection in hemodialysis units: effect of isolation? Ren Fail 24: 639–644, 2002
      77. Saxena AK, Panhotra BR, Sundaram DS, Naguib M, Venkateshappa CK, Uzzaman W, Mulhim KA: Impact of dedicated space, dialysis equipment, and nursing staff on the transmission of hepatitis C virus in a hemodialysis unit of the middle east. Am J Infect Control 31: 26–33, 2003
      78. Centers for Disease Control and Prevention (CDC): Update: Staphylococcus aureus with reduced susceptibility to vancomycin—United States, 1997. MMWR Morb Mortal Wkly Rep 46: 813–815, 1997
      79. Centers for Disease Control and Prevention (CDC): Staphylococcus aureus resistant to vancomycin—United States, 2002. MMWR Morb Mortal Wkly Rep 51: 565–567, 2002
      80. Centers for Disease Control and Prevention: CDC Infection prevention checklist for outpatient settings: Minimum expectations for safe care. 2011 version 1.0. Available at: Accessed April 2, 2014
      81. Centers for Medicare & Medicaid Services: Surveyor laminates. Available at: Accessed May 28, 2014
      82. Centers for Medicare & Medicaid Services: Conditions for Coverage (CfCs) & Conditions of Participations (CoPs). November 6, 2013. Available at: Accessed April 2, 2014

      chronic dialysis; chronic hemodialysis; vascular access; dialysis access; immunology

      Copyright © 2015 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.