NEW YORK (360Dx) – More than a year after a Centers for Medicare and Medicaid Services proposal recommended that hospitals put in place robust antimicrobial stewardship programs, many hospitals in the US are still out of compliance, according to diagnostics company BioMérieux.
At the American Association for Clinical Chemistry meeting recently in San Diego, Stefan Willemsen, president and CEO of BioMérieux's US division, said that the company is responding by deploying diagnostics consultants within hospitals to support their decision-making around implementing diagnostic tests that would augment antimicrobial stewardship programs.
"There are 10,000 hospitals in the US and a lot of them don't have a sepsis or antimicrobial stewardship protocol," Willemsen said, adding that while several important groups are proposing that hospitals put programs in place, the main challenge is how to help physicians understand how to effectively use the many testing options that are available to make clinical decisions.
BioMerieux noted that in its efforts to help hospital systems navigate through the sepsis testing options, it is approaching large healthcare systems. Advising hospitals about optimal sepsis and antimicrobial stewardship protocols and tests also provides opportunities for sales of its many infectious disease testing products.
"We have diagnostics tools that produce so much information, so we are telling physicians that we can help them decide what's best to use and when and with which constituent across the hospital," Willemsen said.
While clinicians and pharmacists may have different information needs, laboratory directors also need to implement stewardship programs that enable them to produce the right information with the right level of priority.
To that end, the firm has deployed a workflow optimization team that works with laboratories to advise them about lab stewardship. "If they want to purchase a high-volume MALDI-TOF mass spectrometry instrument, for example, we work with them upfront to help them figure out how it's going to be of best use in their hospital system," Willemsen said. "We want to make sure that they are optimizing use of the technology as best as they can."
The need to effectively advise physicians has been elevated in importance with the onset of proposals for antimicrobial stewardship programs in hospitals, he said.
In 2016, the Centers for Medicare and Medicaid Services released a proposed rule change to its conditions of participation in Medicare and Medicaid. The proposal, which has not yet been finalized, would require hospitals to implement antibiotic stewardship programs in order to participate in either program.
By proposing the rule, CMS takes aim at reducing hospital readmissions, barriers to care, and the incidence of hospital-acquired conditions by improving the use of antibiotics.
The Joint Commission, an independent, not-for-profit organization that accredits and certifies nearly 21,000 health care organizations and programs in the US, announced a standard that became effective at the beginning of this year that also requires antimicrobial stewardship programs in hospitals.
Hospitals will struggle to keep up with proposed and recommended requirements, Willemsen said, adding that part of their challenge is a lack of knowledge regarding how to implement diagnostic tests for medical conditions, such as sepsis, that can contribute to increasing antimicrobial resistance among patients if they are not properly applied.
Physicians quickly prescribe antibiotics when they suspect that their patients might have sepsis, because the patients' condition can rapidly deteriorate and the rate of mortality increases at an alarming rate every passing hour.
"All along, the doctor is trying to take care of the patient and keep them alive, and that's why they put them on antibiotics upfront," Vince Tumminello, director of market access at BioMérieux in the US, said in an interview.
In testing for infectious diseases such as sepsis, a physician typically takes blood samples to conduct culture and clinical chemistry tests. A test for levels of procalcitonin measures the host's response to an infection.
"It doesn’t tell you about the type of organism," Tumminello said, "but it does tell you whether the infection is bacterial or not. This is important because putting a patient on antibiotics if it's viral could increase antibiotic resistance. The procalcitonin test tells you whether you should administer antibiotics or not within 20 minutes."
Additionally, the procalcitonin marker is used to measure a patient's response to therapy. Dipping levels of PCT means the patient is responding well, but if the levels continue to increase it means the patient is not effectively responding to what's been prescribed, he said.
Following a blood culture, physicians usually apply tests to identify the pathogen and then proceed to measuring that pathogen's susceptibility to an antibiotic. They have many options for pathogen identification. High volume MALDI-TOF mass spec instruments can "work up a pathogen ID within five minutes if needed," he said. Alternatively, the firm's BioFire FilmArray instrument provides an ID from a blood culture bottle within an hour, while testing for 26 organisms and three resistance genes.
"We are working in general on the integration of all of this, so that hospitals can improve the use of these tools," Willemsen said. "BioMerieux is focused on providing rapid, accurate, and comprehensive results for infectious disease diagnostics, and that's what's needed to address these issues with sepsis and antimicrobial resistance."
He noted that the company believes that the growing rate of sepsis infections and the increase in antimicrobial resistance are "huge healthcare problems, and there are still a lot of things to improve and technology that can help."
In addressing antimicrobial stewardship concerns, the integration of technology and information in the hospital and making sure that information gets to the physicians as quickly as possible — day and night — is critical, he said. "That will make the difference," he said, "because you are dealing with things that kill people very quickly, and the important paradigm is time-to-result."