In 2002, the most recent year for which statistics are available, the estimated number of hospital-acquired infections (HAIs) in US hospitals (including federal facilities) was approximately 1.7 million.1 An estimated 98,987 deaths resulted.1

Using Klevens’ numbers and other data, the CDC estimated that the overall direct annual medical costs of HAIs to these facilities ranged from $28.4 to $33.8 billion (after adjusting to 2007 dollars using the CPI for all urban consumers) and $35.7 billion to $45 billion (after adjusting to 2007 dollars using the CPI for inpatient hospital services).2

However, “After adjusting for the range of effectiveness of possible infection-control interventions, the benefits of prevention range from a low of $5.7 to $6.8 billion (20% of infections preventable, CPI for all urban consumers) to a high of $25.0 to $31.5 billion (70% of infections preventable, CPI for inpatient hospital services).2 This means that even the “least successful” prevention efforts still can result in billions of dollars of savings.

Of course, to save money, hospitals must spend money, and many don’t have this luxury. However, manufacturers of HAI-control-related products are focusing on developing tools that can help to create efficiencies and bring a big return on investment.

Return On Investment

Hospitals often create an HAI-infection-control program from a cost perspective. “The challenge in general is that the hospitals have to figure out from a reimbursement perspective how they are going to pay for it. So, every hospital has to look at what’s going to work within their institution,” says John McCune, group marketing manager of PCR microbiology for Roche Diagnostics, Indianapolis.

Prevention efforts can range from the simple and inexpensive, such as hand-washing campaigns, to elaborate, costly protocols involving the clinical laboratory. However, carefully designed programs that maximize use of clinical diagnostic capabilities may see greater results.

“Patient outcomes and even cost savings can be directly related to how fast the appropriate diagnosis can be made. In the case of C. difficile infections, the vast amount of the cost is directly related to an increased length of stay, not to mention the expense of the preventative measures associated with patient isolation,” says Norman Moore, director of medical affairs with Alere, Princeton, NJ.

As payors increasingly refuse to pay for HAIs and patients demand hospital-specific HAI data, health care institutions may soon begin to find that not having an effective HAI-control program in place can cost more than paying for prevention.

Designed to run on Cepheid’s GeneXpert system, the Xpert C. difficile test detects both C. difficile and the epidemic strain C. difficile 027.

Clinical Lab: Private Eye

Hospitals with laboratories have built-in potential resources. “Clinical laboratories are in charge of running the tests for HAIs within an ‘active surveillance’ program of a hospital structure in both countries with national guidelines for screening hospital patients at admittance and release and those without,” says Thomas Iff, international division marketing manager of the Clinical Microbiology Division at Bio-Rad Laboratories, Hercules, Calif.

With implementation of the Patient Protection and Affordable Care Act in the United States, in 2015 “the quartile of hospitals with the highest rates of HAIs will be penalized one percent of their Medicare payment,” says Mary Ann Silvius, director, new product and business development, Microbiology North America, Thermo Fisher Scientific, Waltham, Mass. At present, 30 states have already enacted HAI public reporting laws, and six have laws pending.

“To combat the spread of HAIs, active surveillance—including MRSA screening and VRE screening—is often part of a multidisciplinary infection prevention program,” Silvius says. How useful this screening is, however, depends on turnaround.

“The faster a laboratory can identify whether a person has HAIs, such as C. difficile or MRSA, the faster that patient can be isolated from other patients,” Moore says. At the same time, the hospital also wants to know who doesn’t need to be isolated.

Doing the Right Thing

Making the appropriate call on isolation can help to suppress and interrupt the transition cycle of HAIs; isolating an infected patient helps to prevent the spread of disease. Isolating an uninfected patient can be a costly waste of resources. “Only about 10 or 15 percent of [patients tested] will come up positive for C. difficile, even with the most sensitive test,” says David H. Persing, MD, PhD, executive vice president and chief medical and technology officer for Cepheid, Sunnyvale, Calif.

If protocols call for the patient to be preemptively placed into isolation—which, according to Persing, is a common response from physicians accustomed to waiting 2 days for results—that means a majority of patients are isolated unnecessarily. “And that means you are essentially cutting in half the number of beds you have for patients in isolation. From a bed-management standpoint, that’s a problem for hospitals because they need to preserve bed capacity so they can admit patients when they need it,” Persing says.

Laboratory-Acquired Tools for HAIs

To achieve a higher return on their investment, laboratories need tests that offer high sensitivity and specificity, as well as positive and negative predictive values (PPV and NPV, respectively). “Predictive value is essential because it is a measure of the likelihood that a positive test result indicates disease or that a negative test result may rule out disease. Low PPV translates into more false positive results, while low NPV translates into more false negative results,” Silvius says. Both impact treatment decisions.

Subsequently, the diagnostic and surveillance products recently released by manufacturers feature improved performance, faster turnaround, and easier use. “There are new generations of molecular techniques that, depending on the analyte and matrix, are becoming the new gold standard,” Moore says.

Moore expects multiplexing assays to follow next. “In the future, we will be able to not only identify bacteria quickly, but to also get significant profile information that can give a full antibiotic profile and help determine where the person acquired the HAI,” he says.

To stay in the know on HAIs, visit this site often.

Menus should also expand. Persing anticipates new diagnostics focused on gram-negative HAIs, such as multiresistant Pseudomonas aeruginosa, Acinebacter, and the family of Klebsiella Pneumoniae Carbapenemase (KPCs). Currently, Cepheid is working on development of a cartridge that can rapidly detect the KPC-resistant markers for use in tracking the infections and identifying carriers.

Which tests belong on a facility’s infectious disease screening menu is an institutional decision, and organizations are challenged to balance risk, safety, visibility, and budget in making this and other infection-control decisions. “The risk of transmission is six times greater if a carrier is identified than not identified; 19 percent of patients colonized with MRSA at admissions can develop infection. The statistics are pretty common,” says Roche’s McCune, “but the key people have to keep in mind is that we’re really dealing with a marathon here and not a sprint.” That approach will help health care institutions hold off HAIs.

Renee Diiulio is a contributing writer for CLP.

  1. Klevens RM, Edwards JR, Richards CL, et al. Estimating health care-associated infections and deaths in US hospitals. Public Health Reports. March-April 2007;122:10-166.
  2. Scott RL. The direct medical costs of healthcare-associated infections in US hospitals and the benefits of prevention. Division of Healthcare Quality Promotion National Center for Preparedness, Detection, and Control of Infectious Diseases Coordinating Center for Infectious Diseases Centers for Disease Control and Prevention. March 2009. Available at: Accessed December 14, 2010.