Communicable diseases need a community in which to spread, and hospitals and other medical care facilities are infection havens. Crowded floors and immunocompromised patients are tourist traps for disease. Over time, each facility has become its own Galapagos Island—harboring specific diseases that show resistance to specific drugs.

These organisms pose real threats. Approximately 90,000 deaths per year are attributable to hospital nosocomial infections.1 In 1995, the Centers for Disease Control and Prevention (CDC of Atlanta) estimated that hospital-acquired infections cost $4.5 billion and contributed to more than 88,000 deaths.2

The organisms are also becoming more difficult to treat. As they adapt to their environments, they show greater and expanded resistance to drugs. “More than 70% of the bacteria that cause nosocomial infections are resistant to at least one of the antibiotics most commonly used to treat them,” according to the National Institute of Allergy and Infectious Diseases.1

Hospitals are therefore required to have infection-control programs, and laboratories—particularly the microbiology lab—are critical to many of these efforts. “The lab is everywhere in our goals. The average ICP’s [infection-control practitioner] day starts with lab reports, which help us to identify how we’ll spend our time,” says Peggy Prinz Luebbert, MS, MT(ASCP), CIC, CHSP, system consultant for infection control, quality management services for Alegent Health (Omaha, Neb).

These reports identify hospital organisms and antibiotic-resistance patterns and increasingly are produced with automated systems. Automation brings the benefit of faster turnaround and electronic trend monitoring.

Laboratorians are therefore in an excellent position to discover new trends, perhaps giving the hospital time to be proactive rather than reactive. “I depend on the lab to note anything out of the usual and to let the ICP know immediately. A good lab/IC relationship will allow that,” Luebbert says.

Elimination Rather Than Detection
Infection can spread in so many ways, particularly in a hospital where invasive procedures occur daily. Part of every program is careful monitoring of the blood supply. Donated blood is now screened for a variety of organisms before being used for transfusions. But a new technology from Cerus Corp (Concord, Calif) may change that.

Rather than screening blood for pathogens, the INTERCEPT Blood System uses proprietary technology, called Helinx, to cross-link the genetic material of these organisms in the blood so they are rendered inert, according to Bill Dawson, CFO. “The system is indiscriminate, affecting all pathogens that contain DNA or RNA,” Dawson says. Blood components, such as red cells, plasma, and platelets, are unaffected.

The technology rests within a desktop instrument, and the process takes about 8 minutes. “Our limitations include a lack of data to suggest the inactivation of prions and poor inactivation data on hepatitis A, which is tightly wound and therefore difficult to inactivate,” Dawson says. But blood banks have viewed the technology as extremely effective, and in Europe, where the system has been adopted commercially, they are no longer screening for bacteria or cytomegalovirus.

The technology has been in development since the company’s founding in 1992 and has been approved in Europe for platelet products. “We have performed in excess of 30,000 transfusions in a commercial setting in Europe now,” Dawson says.

Clinical trials for plasma and platelets have been conducted in the United States, though Dawson notes there is no timeline in place for US regulatory approvals. “The US has been historically late to adopt blood-product technologies,” Dawson says. But the company has begun conversations with the US Food and Drug Administration, and someday we may be able to inactivate the dangers inherent in blood rather than just screen for them. —RD

Control and Prevention
Luebbert speaks from experience. “A few years ago, I had a laboratorian call at four o’clock on a Friday afternoon. She was a chemist and had been running liver profiles. Three of them had been off the chart, which she had never seen before. She wasn’t sure if it was anything, but wanted to let me know in case it was a hepatitis issue. I pulled up the patients’ charts and discovered that one had been diagnosed with hepatitis A. By the time I had checked the other two and talked to the physicians, we had 20 more cases, all due to food poisoning at a local restaurant. But because of the laboratorian’s astuteness, we were able to prevent secondary transmissions,” Luebbert says.

Effective infection-control programs are focused as much on prevention as they are on control. “Our number one general goal is to prevent infections in patients, employees, and staff. I think the average infection-control practitioner is now spending a lot more time on the prevention of infections rather than their control,” Luebbert says. She notes that the Association for Professionals in Infection Control and Epidemiology (APIC of Washington, DC) is looking into changing its name to one that incorporates the term “prevention.”

To meet both goals, the scope of the programs has expanded. “We are doing more concurrent surveillance. Rather than looking at the rate of infections retrospectively, we look at the patient coming in, asking what is wrong with the patient now and what can we do to prevent infections in this patient or the transmission of infection to others? What type of procedures will he undergo? Could these introduce infection, and what can we do to make sure that doesn’t happen?” Luebbert says.

Her team may be asked to evaluate new equipment and devices for infection risks before purchasing decisions are made. The lab is charged with running the reports that can help to identify new trends. Each hospital will find that it has different microorganism populations to deal with. Hospitals are required to have infection-control programs, but how they achieve control is up to them.

Goals are dependent on the facility, its specific geographic location, and its patient population. “These are based on a risk assessment taken at each organization, and differ tremendously from organization to organization depending on the community they are in, the programs and services they offer, and the population themselves,” says Louise Kuhny, RN, MPH, CIC, associate director of standards interpretation at the Joint Commission on Accreditation of Healthcare Organizations (JCAHO of Oakbrook Terrace, Ill).

Labs on the Front Lines
Kuhny notes that JCAHO has two standards that address the lab’s role, which is expected to be collaborative, particularly with regard to the identification of organisms and the individual risk within the organization. “One standard discusses the components of an IC program, and the other talks about design, implementation, and collaboration,” Kuhny says.

Part of that collaboration is education. New ICPs at Alegent spend 2 weeks in microbiology when they first start and again 6 months later. “They follow the microbiologists and serologist around. Some two-year ICPs have now requested it annually. They’ve found that as their infection-control knowledge base increases, they are more apt to understand what is going on in the lab and can communicate that to nurses and physicians on the floor,” Luebbert says. Translation of results can be key to effective solutions by care providers.

The lab has been crucial to efforts at Sharpe Metropolitan Medical Campus (San Diego) to understand resistance patterns of bacteria on a floor and to prevent transmissions, according to Shannon Oriola, RN, CIC, COHN, lead ICP.

The same is true at the Ralph H. Johnson Medical Center (Charleston, SC). “The clinical microbiology lab is crucial in isolating suspected pathogens from the hospital environment and determining antimicrobial susceptibility so that patients can be treated maximally with regard to appropriate agents. The lab can keep a registry of antibiotic susceptibility for that institution as an aid to prescribing clinicians,” says Joseph F. John, Jr, MD, FACP, FIDSA, FSHEA, chief of medical service in the Department of Veterans Affairs at the center, and professor of medicine at the Medical University of South Carolina (Charleston).

“Most infection-control programs base a lot of their surveillance, if not all, on results from the clinical lab. Increasingly, there are things the lab is doing in terms of enhancing surveillance using molecular techniques like PCR [polymerase chain reaction] to screen for organisms, such as VRE [vancomycin-resistant enterococci],” says Michael A. Pfaller, MD, director of the molecular epidemiology and fungus testing lab at the University of Iowa (Iowa City).

Early identification and isolation help to limit the spread of germs. New technologies are allowing the laboratory to provide much more accurate and timely information about organisms.

It takes Individuals
Peggy Prinz Luebbert, MT(ASCP), CIC, CHSP, system consultant for infection control, quality management services,  at Alegent Health, does not think she has done anything out of the ordinary, but the Association for Professionals in Infection Control and Epidemiology (APIC) disagree. The association honored Luebbert with the APIC Presidents’ Distinguished Service Award at its Annual Meeting in Florida this year.

Luebbert says there are many people who do what she does around the globe and in the United States. “Infection control people have to be investigators—nosy, motivating, and aware of what is going on around them so that they may respond quickly,” she says.

APIC’s criteria is a little different, however, although leadership and service are considered. Recipients of the award are also required to be in good standing and have volunteered on a national level with the association. APIC boasts roughly 10,000 members worldwide.

Luebbert has 20 years of experience in the field, 10 of them with Alegent Health. She has been a member of APIC since 1985, serving on several committees and as an instructor. Luebbert believes two specific accomplishments helped her achieve this honor: She worked with national organizations to change federal guidelines covering the use of alcohol-based products in the operating room, which had been previously banned, and she cochaired a committee with the Clinical Laboratory and Standards Institute (CLSI; formerly NCCLS) to develop national guidelines on the management of an equipment recall. APIC also notes her work facilitating the creation of a hospital pandemic influenza plan with the Nebraska Department of Health. —RD

The Laboratory Armament
These tools include new testing methods, new analyzers incorporating more automation, and new software programs that create and deliver tailored and insightful reports. “Sometimes cost is an issue, but there is newer technology becoming available to the market than can be used to more rapidly identify infectious agents,” Oriola says.

She cites QuantiFERON-TB Gold by Cellestis Inc (Valencia, Calif) as one example of advances that can produce more accurate results more quickly. The test, approved by the US Food and Drug Administration (FDA of Rockville, Md) in 2005, is a blood test that produces a yes or no answer, rather than a subjective result, within a physician’s visit. “These newer diagnostic tests can certainly help,” Oriola says.

Real-time PCR is another newer technology, one that is providing quite a bit of assistance. Real-time PCR can help to identify methicillin-resistant Staphylococcus aureus (MRSA) within 2 hours. Automated systems are available from companies such as bioMérieux Inc (Durham, NC) and Dade Behring (Deerfield, Ill).

“There are a spectrum of devices that can be used in the clinical microbiology lab, including modern blood-culturing techniques that feature rapid detection of bacterial and fungal growth, rapid viral antigen detection, and rapid bacterial product detections, such as that for helicobacter pylori,” John says.

There are also systems that don’t require significant investment in technology. Advances have taken place in traditional culturing as well. “For instance, chromogenic agar allows rapid detection of MRSA or VRE,” Pfaller says. CHROMagar MRSA, a culture dish produced by M-Tech Diagnostics Ltd of Cheshire, England, produces results within 24 hours.

Reporting for Work
Technology helps to conduct surveillance more effectively and efficiently. Automated reports reveal a large amount of information about what is happening in the lab.

Luebbert cites reports that review the numbers and types of tests ordered. “How many tests for rotovirus were ordered? A large number can indicate a lot in the community. And if it’s in the community, it will be in the hospital. So, we try to identify potential outbreaks before they occur,” Luebbert says.

At Sharpe Metropolitan Medical Campus, the infection-control program uses syndromic surveillance to monitor community disease. “We look at the logs of symptoms of people coming in to spot patterns,” Oriola says, noting this is also how SARS was identified in Toronto. “We proactively look for infection and work with the public health department to prevent and control it,” Oriola says.

Regular detective work helps, too—Oriola calls it “shoe-leather epidemiology.” “We talk to the staff on the floors to learn about anything unusual. If the lab sees unusual organisms in more than one patient, they’ll call to ask about the potential source. They would be one of the first to identify an organism, whether nosocomial or bioterrorist,” Oriola says.

With concerns about bioterrorism, the detection of which also falls under the purview of infection-control programs, these efforts are key to locating an organism that a team may not know it should be looking for. When a team has found an organism it cannot identify, bioterrorist or otherwise, it typically forwards the sample to a state health lab or the CDC. These labs have access to a national database that compares results for more unusual organisms, according to Margaret Peck, MS, MT(ASCP), director of the lab accreditation program at JCAHO.

“There may be certain organisms that a lab, in conjunction with the infection-control practitioners, have identified as requiring immediate notification when isolated,” Pfaller says.

Community-Acquired Benefits
Just as the hospital departments have to work together to prevent and control infection within their specific community, so should institutions collaborate on a broader scale to prevent and control infection within their larger communities.

“There needs to be a two-way street between the hospital and the community. The hospital needs to know what to look for from the community so that appropriate precautions and preventive measures can be put in place,” JCAHO’s Kuhny says.

Oriola finds other benefits from large-scale collaboration. “By collaborating, a hospital system can benefit from information on best practices as well as purchasing and other areas,” Oriola says. Her facility participates in a local medical-society commission whose members compare antibiograms to look for larger trends.

Luebbert finds that much collaboration goes on with APIC groups. “We interact frequently. For instance, if we pick up an infection in a patient admitted to our site that was actually acquired during another procedure elsewhere, we’ll call that facility to let them know,” Luebbert says.

Luebbert’s local community in Omaha, as part of its pandemic preparedness, has worked together to install the same equipment in each facility’s medical response unit. “We wanted to make sure that the equipment we will rely on in a disaster can be run by everyone in case we need to share staff,” Luebbert says. She offers respirators and transport equipment as examples.

Team effort is key to infection prevention and control. “If you are part of a team effort to minimize nosocomial infection, you not only provide improved conditions for patients but also help the institution’s bottom line by reducing cost required to prevent them,” University of Iowa’s Pfaller says. Patients, the lab, the ICP, purchasing—just as it takes a community to spread disease, so too it takes one to fight it.

Unseen Pests
The Centers for Disease Control and Prevention (CDC of Atlanta, Ga) has identified 26 infectious diseases that may be acquired in health care facilities. These include:
• Acinetobacter
• Bloodborne pathogens
• Burkholderia cepacia
• Clostridium difficile
• Clostridium sordellii
• Creutzfeldt-Jakob Disease (CJD)
• Ebola (viral hemorrhagic fever)
• Gastrointestinal (GI) infections
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV/AIDS
• Influenza
• MRSA [methicillin-resistant Staphylococcus aureus]
• Mumps
• Norovirus
• Parvovirus
• Poliovirus
• Pneumonia
• Rubella
• SARS
• S pneumoniae (drug resistant)
• Tuberculosis
• Varicella (chickenpox)
• VISA [Vancomycin intermediate Staphylococcus aureus]
• VRE [Vancomycin resistant enterococci]

Louise Kuhny, RN, MPH, CIC, associate director of standards interpretation at the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), says it is hard to identify certain organisms as being of concern because there is a lot of local variance in resistance. However, she notes that MRSA, VRE, and gram-negative drug-resistant organisms continue to pose challenges in the United States, as do a number of viral, fungal, and bioterrorist organisms.

“One of the hot topics over the past year has been clostridium difficile,” says Shannon Oriola, RN, CIC, COHN, lead infection control practitioner at the Sharpe Metropolitan Medical Campus (San Diego). However, Oriola concurs that MRSA, VRE, and drug-resistant gram negative rods have been receiving more attention as a result of their drug resistance. “There have not been many new antibiotics on the market, and resistance continues to develop, so we have fewer tools to deal with them,” Oriola says.

To keep up with which organisms are growing in prevalence, laboratorians can refer to the CDC’s Morbidity and Mortality Weekly Report (MMWR) available on the organization’s Web site (www.cdc.gov). —RD

Renee DiIulio is a contributing writer for Clinical Lab Products.

References
1. National Institute of Allergy and Infectious Diseases. The problem of antimicrobial resistance. April 2006. Available at www.niaid.nih.gov/factsheets/antimicro.htm Accessed August 28, 2006.

2. Weinstein RA. Nosocomial infection update: Emerging infectious disease. Atlanta, Ga: Centers for Disease Control and Prevention. July–Sept 1998;4:3.