Friday, December 23, 2016 Written by Laureen Haynes, MT(ASCP), Systems and Solutions Manager, Cepheid

The C. difficile Challenge

A Typical Patient Pathway

This year the “superbug” that continues to challenge our health care systems across the country and around the world is C. difficile. The Healthcare Cost and Utilization Project (HCUP) has documented how the average cost to treat a C. difficile healthcare-associated infection (HAI) has jumped from approximately $3,600 (2001)1 to $22,500 (2009)2 per event, and length of stay (LOS) from 3 days to 11.5 days. This increase can be specifically correlated with the appearance and spread of a hyper-virulent strain (NAP1/027). At the same time, the rate of CDI stays has also increased, as shown in Figure 2. Translated across the patient population, the number of CDI-related stays has increased four-fold2.

Committing to Containment/Control

At this year’s APIC meeting, the Veterans Affairs (VA) healthcare system announced an increased focus on attaining a zero rate of C. difficile infections. The Centers for Medicare & Medicaid Services (CMS) is also targeting CDI as an HAI, and adding it to the list of reportable infections under the Inpatient Quality Reporting (IQR) Program effective January 1, 2013. Healthcare institutions with CDI HAI occurrences could face reimbursement penalties beginning in 2015. And, as those who participate in LinkedIn discussion groups or attend regional/national shows can attest, controlling C. difficile infections (CDI) is a constant topic of conversation.

Combatting and controlling the spread of C. difficile requires a coordinated effort by multiple departments in the healthcare organization. Figure 3 illustrates a typical pathway experienced by patient suspected of having C. difficile. Guidelines suggest this patient be admitted into a private* room and placed in isolation until his status can be determined. From the Bed Manager’s perspective, coordinating this patient generally takes much longer than a non-isolation patient. This can back up the ED and slow the health system down.

A Typical Patient Path

When the patient is placed in isolation, most hospitals also begin empiric treatment with either metronidazole or PO Vancomycin. Lab results for C. difficile tests may not be available for at least a day. Longer waits are possible, depending on the frequency of batch testing, lab not running 7 days per week, and/or sending out for confirmation.

Enzyme immunoassays (EIA) are the most commonly used tests for C. difficile. As recently as 2006, 95% of U.S. hospitals were using EIA for C. difficile testing. Unfortunately, EIA sensitivity is less than ideal (sensitivity 33%)3. The low level of sensitivity reduces the confidence physicians have in negative results, so patients remain in isolation and continue empiric treatment until their symptoms subside. They may also have repeat tests to confirm the presence of C. difficile. This not only takes additional time, but adds to the total cost of care.

High Transmission Risk Points

Since a majority of patients with suspected CDI are actually negative, hospital staff and visitors are typically not fully compliant in using personal protection equipment. Even one missed case or false negative can ripple outward to other patients, causing comorbidity with new treatment workflow. Another transmission risk is found upon discharge. When patients treated for CDI are discharged, a special terminal clean is performed on the room. The question raised by the EIA sensitivity issue is: How do you clean a room where the patient tested negative for CDI? Was it a true negative? If it wasn’t, the next patient will be at risk for contracting a C. difficile HAI.

What If You Had Rapid, Trusted Test Results?

In looking at how the lab can positively impact the workflow in identifying and treating CDI patients, the questions to ask are:

  • What if you could know a patient’s C. difficile status within 2 hours total TAT, with a highly sensitive and specific PCR assay?
  • What if this capability was available 24 hours a day, 7 days a week?
  • How would this improve the effectiveness of your treatment, efficiencies in your operations, and reduce unnecessary expense?

Figure 4 maps out how patients who present at the Emergency Department with CDI symptoms can be immediately tested, with results returned from the lab in less than an hour. True positives (along with NAP1/027 callout) are admitted into isolation and treated as appropriate. Negatives are admitted, diagnosed, and treated as necessary.

For patients who test negative by PCR, unnecessary supplies are not wasted, ineffective antibiotics are not consumed, precious resources are conserved, and clinicians can focus on what is truly ailing the patient. There is a substantial additional benefit of treating the right patients at the right time with the right intervention — the reduction of CDI transmission to other patients. The result: fewer cases of CDI HAI. The costs and risks associated with CDI are increasing. Health professionals are asking what number of CDI HAI cases is realistic and optimal. According to the both the CMS and VA, zero is the answer.

How is your organization tackling the C. difficile challenge?
Let us know, at This email address is being protected from spambots. You need JavaScript enabled to view it..

To prevent transmission of C. difficile, early detection and isolation of patients with CDI is essential.”

CDC’s MMWR: Vital Signs: Preventing Clostridium difficile Infections. March 9, 2012 / 61(09);157–162

1. Kyne L, Hamel MB, Polavaram R, Kelly CP, Health care costs and mortality associated with nosocomial diarrhea due to Clostridium difficile. Clin Infect Dis 2002; 34:346-353.
2. Clostridium difficile Infections (CDI) in Hospital Stays, 2009. HCUP Statistical Brief #124,
January 2012, p. 4.
3. Tenover, et al. Journal of Clinical Microbiology, October 2010, p. 3719-3724, Vol. 48. No. 10