By Kelly M. Pyrek
To understand where clinical microbiology is going in the future, it's helpful to take a quick trip back in history. Years ago, the Study on the Efficacy of Nosocomial Infection Control project established the scientific basis for claims of efficacy of hospital-acquired infection surveillance and control programs, and the importance of clinical microbiology laboratories (CMLs) was emphasized. (Scheckler, 1998).
While the CML is now at the heart of any modern hospital infection prevention and healthcare epidemiology program, it has only been about 15 years since the Society for Healthcare Epidemiology of America (SHEA) established a consensus panel to develop recommendations for optimal infrastructure and essential activities of infection prevention and epidemiology programs in hospitals. In 1996, a SHEA consensus panel developed an assessment of the needs for an effective hospital-based infection control and epidemiology program and identified eight elements: managing critical data and information; setting and recommending policies and procedures; compliance with regulations, guidelines and accreditation requirements; employee health; direct intervention to prevent transmission of infectious diseases; education and training of healthcare workers; personnel resources; and non-personnel resources.
Historically, CMLs have supported infection prevention and healthcare epidemiology programs by extracting data from the analysis of cultures taken from potentially colonized and/or infected patients, with this information having enormous potential for the early detection of healthcare-associated infections (HAIs).
Fast forward to 2011, and CMLs have taken their rightful place in the role call of agents working to reduce and eliminate healthcare-associated infections (HAIs). As Peterson and Brossette (2002) note, "Modern hospital epidemiology only began in the mid-1960s, but since that time the clinical microbiology laboratory has progressively demonstrated the critical roles it can serve for ongoing management and control of healthcare-associated infectious diseases."
Although their opinion is aging, Peterson and Brossette (2002) made an early, eloquent case for the importance of the CML: "The necessary contribution from the laboratory includes surveillance, providing for a systematic observance and measurement of disease, as well as molecular typing of microbial pathogens. Present and future needs for laboratory-based surveillance will require reliable detection of new pathogens that emerge as causes of important health care-associated infections, which implies accurate identification of microbial organisms; recognition of new or emerging antimicrobial agent resistance; and participation in active surveillance for outbreaks, including preparation of specialized media as well as molecular typing. This contribution dictates a strong collaboration between the hospital epidemiologist and the clinical microbiologist, with a consequent positive impact on both the infection control program and the diagnostic laboratory. Such cooperation will be needed as we move to a future where pathogens of concern not only spread within the hospital but have the potential to affect both inpatients and outpatients, healthcare workers, and their households."
This need for collaboration is a central theme within the presentation that Carol A. Rauch, MD, PhD, FCAP, medical director of microbiology for Baystate Health in Springfield, Mass. makes to numerous lab-based groups each year. She points to the statement from Diekema and Pfaller (2007) that, "A good working relationship between clinical laboratory and infection control personnel will greatly facilitate the investigation and control of healthcare-associated infections."
"Pfaller and Diekema emphasized the need for partnerships," Rauch says. "That sounds obvious but it takes time to learn this important lesson and gain perspective through your own experiences that you can share with others in the fight against HAIs."
It can be a tall order to get all of the key stakeholders on the same page, but Rauch says healthcare professionals must do so for the sake of upholding patient safety -- the common, unifying goal of all clinicians. "We are not always aligned to go in the same direction and many departments can sometimes seemingly work at cross purposes, but we must remember that we do the work we do -- HAI monitoring and testing -- to care for our sickest patients. In the clinical microbiology lab, we really are keeping our fingers on the pulse of the data stream, looking for clusters and trends, and educating others about the meaning behind our results -- the more robust these efforts are, the safer our patients will be."
Rauch emphasizes that CMLs play a critical role in the control and elimination of HAIs, and that it's not merely about testing clinical specimens to support the diagnosis and management of infections in patients -- CMLs also play a key role in data collection and analysis (including providing antibiograms and other aggregated data sets), reporting results to the state public health department, and much more. Following Pfaller and Diekema's advice, Rauch says CMLs also inform the infection control committee about feasibility and laboratory resources necessary to support the committee's goals, educate clinicians about the strengths and limitations of tests, and save isolates for possible additional testing. On any given day, CMLs could be managing a surge demand triggered by an outbreak, pandemic or other infectious disease emergency. Clinical microbiologists and other CML professionals must also keep up with the medical and scientific literature, new technology and numerous guidelines whose tenets may sometimes be in conflict with other established guidance, Rauch says. The CML has many masters, Rauch emphasizes, explaining that in addition to working with infection preventionists and epidemiologists, CMLs also support the needs of hospital, regional and state committees, and special project-oriented collaboratives.
Chief among the many duties of the CML is, of course, managing the avalanche of incoming cultures and other tests driven by an increased attention to infectious diseases overall, and to HAIs specifically. Rauch also points to the increased need for surveillance activity by infection preventionists, epidemiologists and clinical microbiologists within the context of the increasing prevalence and complexity of multidrug-resistant organisms (MDROs). "The microorganisms, the tests used to detect them, and the drugs used to fight them, are all tied together in a complicated chess game of sorts. Because of this, we all must learn how to work together because if we don't, we could lose that chess game."
With such demands placed on CMLs, it might be easy to forget about the budgetary and resource constraints they face. As Peterson (2001) notes, in recent years in an effort to contain costs, healthcare institutions have "attempted to ‘restructure, centralize or consolidate laboratory services, including clinical microbiology laboratories, into larger working groups that serve multiple hospitals and retain fewer staff with dedicated microbiology expertise."
Rauch points to current challenges facing CMLs, including personnel shortage at all levels, whether it's bench technologists, laboratory managers or directors, that impact the ability for labs to respond to needs and implement change. Another challenge is the evolving complexity of data coupled with the decreasing availability of information technology (IT) personnel who also understand the laboratory and/or the clinical context involved. Yet another important challenge, Rauch says, is the pressing need to vet the data used when reporting rates of various findings, and CMLs sometimes need to remind their partners that they either can "have it fast, or have it right."
Rauch says she asks infection preventionists, hospital epidemiologists and infectious disease specialists to take into consideration logistical constraints when asking for new tests, and to actually help with the processes. "New tests at the very least require administrative approval, evaluation and documentation of performance characteristics, writing procedures, training staff, educating laboratory users, and programming a variety of computer systems, and all of this takes some time. I like when the lab and clinicians can think through what can be done together, as opposed to the 'why-can't-I-have-this-right-now' dynamic. We also must remind people that test results are not always a yes-or--no situation. All tests have performance characteristics and some are much more reliable than others; they all have different features such as speed, or whether you will have an isolate to look at to compare strains."
Rauch continues, "People often just want the results, but there's a lot behind those results that should be evaluated when interpreting them in the context of an individual patient. This is not unique to infection prevention, as I think everyone in healthcare would benefit from some formal training in basic principles of laboratory testing. People seize upon the results once they are in the computer and take them as reality. To us in the lab, there are patterns within that reality that can make us discount certain findings, or focus on others, or even ask for another sample to test. Working with this data takes experience, and I'd love to see more education about what results actually mean and what to do with t hem. This training is now happening more than in the past, and it is absolutely fundamental for patient care.""
