Playbill for the Zero-Tolerance Era for HAIs

Nov. 1, 2010

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Upon completion of this article, the
reader will be able to:

  1. discuss healthcare-associated infections;
  2. understand the development of guidelines for collection and identification of HAIs;
  3. explain the changing landscape for clinical labs; and
  4. define sepsis.

Key players in clinical labs hold starring roles


ealthcare-acquired infections (HAIs) are defined by the World Health Organization as an infection acquired by a patient who was admitted to a hospital or healthcare facility for a reason other than that particular infection; or an infection occurring in a patient in a hospital or other healthcare facility in whom the infection was not present or incubating at the time of admission.1 These infections can either be endemic or epidemic in nature. Endemic HAIs are those infections at the level of occurrence within the hospital setting; while epidemic HAIs occur with an unusual increase in infections above baseline for a specific infection or organism.2 HAIs occur in both developed and developing countries worldwide, contributing to increased lengths of stay in healthcare facilities as well increased financial burdens for both the patient and facility.

During their hospital stays, patients may be exposed to many microorganisms. Contact between the patient and any microorganism does not necessarily ensure that the patient will acquire an infection, as infections can be influenced by a number of different factors. At times, however, patients who come in contact with any number of microorganisms, in fact, fall prey to an HAI. Microorganisms: bacteria, viruses, fungi, and parasites alike can vary in their resistance to antimicrobials as well as their intrinsic virulence factors.3 Patients can be exposed to these microorganisms through a variety of ways: transfer from one patient to another often via the hands of healthcare workers, from part of the patient's own flora; or from inanimate objects such as the environment (e.g., furnishings).3 Research shows that nearly three-quarters of patients' rooms are contaminated with methicillin-resistant Staphylococcus aureus (MRSA) and 69% with vancomycin-resistant enterococci (VRE).

One of the greatest concerns surrounding HAIs is the ability of the microorganisms to be drug resistant. A critical contributing factor for this resistance is that, over time, the consistent, regular use of antimicrobials intended for treatment therapy or prophylaxis has promoted the development of drug resistance in microorganisms.3 Ultimately, the antimicrobial-sensitive microorganisms that are a natural part of the human flora become suppressed, while the resistant strains thrive, reducing treatment options and challenging the pharmaceutical industry to create therapies that will control such resistant microorganisms.3 Among the challenges facing not only the pharmaceutical industry but also healthcare providers today are issues with overprescribing, administration of suboptimal doses, inadequate length of treatment periods, and misdiagnosis leading to inappropriate choices of antimicrobial agents.4

The impact of HAIs can be devastating. For example, it is estimated that bloodstream HAIs are the eighth leading cause of death in the United States.5 According to the Centers for Disease Control and Prevention, HAIs kill more people than AIDS, breast cancer, and auto accidents combined.

Currently, 271 people a day will die from healthcare-associated infections such as MRSA. Raw numbers — assuming for example, an attack rate of 5% and 25 million patients admitted each year — would indicate that 1.25 million patients would acquire a bloodstream HAI each year.5 Further, if 10% of bloodstream infections or 125,000 people were affected, with a 20% mortality rate, an estimated 25,000 lives would be lost each year in this country just from healthcare-acquired blood infections.5 Furthermore, the cost to society in terms of additional expenditures for care would exceed $2,000,000,000 per year.6 Aside from increased mortality and financial costs of HAIs, lengths of hospital stays increase dramatically as a result of an HAI. Associated with an increased length of patient stay is the increased use of drugs, need for isolation, and requirement for expanded laboratory and other diagnostic studies.

Many factors promote HAIs in healthcare settings, including decreased immunity among patients, invasive techniques, medical devices, lack of staff compliance with basic infection-prevention measures, and more. Four major types of HAIs are related to invasive or surgical procedures, including surgical site infections (SSI), central-line-associated bloodstream infections (CLA-BSI), catheter-associated urinary tract infections (CA-UTI), or ventilator-associated pneumonia (VAP).

Transmission of microorganisms within a healthcare facility needs to be identified rapidly, and healthcare workers need to implement interventions to prevent potential outbreaks. In 1974, 2% of staph infections were MRSA; by 2003, that number had increased to 57%.

There are, however, countless players in the journey to Zero HAIs, with clinical laboratories holding a starring role.

Act I, Scene 1: Potential of microbiological diagnosis
Surveillance has been defined as the ongoing, systematic collection, analysis, and interpretation of health data — the final link in the chain of surveillance being the application of this data to the control and prevention of human disease and injury.7 Clinical laboratories clearly contribute significantly to surveillance of HAIs as well as being challenged by the issue of cost containment as an objective associated with HAIs. Clinical laboratories are pivotal contributors in the identification of microorganisms from the specimens they receive; development of guidelines for the collection, transport, and handling of specimens; application of appropriate laboratory standards; innovations in antimicrobial-susceptibility testing; and, finally, the timely communication of all results.

In an effort to maximize the potential for a microbiological diagnosis of a specimen, many clinical laboratories have gone back to the recreating the storyboard. They are changing organizational structures, automating processes, allowing non-repetitive microbiological techniques to be developed in an effort to improve performance in the field, while restoring the consultation role of the clinical microbiologist in many venues, including HAI management.7 Clinical laboratories offer microbial diagnosis, educational intervention, recommendations for the control of HAIs, and a venue for basic research offering resolutions for emerging microbiological threats.7
For example, clinical microbiology is a specific combination of knowledge, attitude, and practice aimed at direct clinical involvement of infectious-disease management, while using core principles of medical microbiology and clinical medicine. This laboratory specialty can significantly contribute to the management of positive blood cultures, management of patients in the intensive-care units, hospital infection-control, public-health microbiology, and development of both hospital and community anti-infective policies.11 This heightened engagement of clinical laboratories will make them the main supporters of Target Zero through their efforts in improving patient outcomes and in helping manage infections within communities.11

Act I, Scene 2: Development of guidelines
Essential to the work of clinical laboratories and to that of healthcare providers as well is proper specimen management. Collection, labeling, transport, handling, and storage are the key ingredients for the microbiological diagnosis of infectious disease as well as for infectious-disease surveillance.7 Specimen collection and transport to the laboratory is an essential part of the culture process. Improperly selected, collected, or transported specimens can generate misleading data that, ultimately, can result in inappropriate patient management.12 Special handling techniques may be necessary for some specimens as well as timely delivery to the laboratory to prevent the death of pathogenic organisms or the overgrowth of commensal organisms.12

Laboratory scientists must lead the way in developing the policies for the integrity of the specimens they manage as they are the clinical experts. Specimen-collection criteria are critical to the laboratory for proper testing and microbiological diagnosis. Without an adequate specimen collected in the proper manner (involving technique in the field), the laboratory staff is unable to effectively test and render diagnosis. Consequently, an inadequate specimen may need to be rejected, thereby delaying diagnosis and treatment.

Finally, the adequate specimen needs to be appropriately packaged and labeled for transport to the laboratory to ensure timely and safe delivery, protecting laboratory staff from potentially infectious materials while being routed. Accurate labeling of specimens can mean the difference between treatment modalities or, potentially, any treatment at all. Once again, clinical laboratory staff as microbiological experts should have significant input in the development of the guidelines for this process as well.7 Timely and accurate microbiological results aid in the data collection and analysis of current HAIs and their emerging counterparts.

Act 2: Appropriate laboratory standards
Once the specimens have been received in the laboratory, it is incumbent upon laboratory staff to implement rapid techniques, immunoassay techniques, microscopy, and molecular testing in accordance with current laboratory standards.7 New laboratory processes are developed each year with improving automation and rapid response times that yield not only obvious clinical benefits but also economic benefits for healthcare facilities.7 Molecular techniques have been valuable in HAI surveillance as well as in identification of emerging pathogens and their population structure.7 Molecular techniques have proven particularly useful during periods of outbreaks of both community pathogens and HAIs in tracking the spread and evaluating intervention strategies.7 Laboratory staff should ensure sufficient internal data management as well as substantial database storage capacity with adequately developed computing equipment and protocols per laboratory standards.7 Further, they need to be developing and updating laboratory programs within current guidelines that incorporate rapid responses in areas such as antimicrobial-susceptibility testing and virology.7

Act 3, Scene 1: Antimicrobial-susceptibility testing
Once the work of diagnosing microorganisms is done, the next imperative step is to perform antimicrobial-susceptibility testing upon these pathogens. First and foremost, susceptibility testing allows physicians to prescribe effective pharmaceutical treatment based upon antimicrobial testing. Performance of this testing based upon current standards and practices helps to ensure the integrity of results. This process involves determining which antimicrobials are tested and reported for each organism. As pathogens become resistant, laboratories provide additional antimicrobial testing for selected resistant isolates.7 The laboratory establishes its protocols for antimicrobial testing, monitoring, and reporting of trends as a result of the presence of bacterial resistance to antimicrobial agents.7 This data analysis provides valuable support for investigations of outbreaks or clusters of resistant microorganisms.7

Through data collection and analysis of antimicrobial-susceptibility testing, laboratory professionals can contribute to the pharmacy's monitoring of antimicrobial use through resistance patterns and trends as correlated with antimicrobial appropriateness.7 An institution's cumulative trends of antimicrobial susceptibilities is known as “antibiograms.” Monitoring patterns of antimicrobial resistance is one function of the antibiogram, as is the contribution for informed empirical antibiotic therapy.8 The Clinical and Laboratory Standards Institute provides several guidelines for antibiograms including their preparation; annual updating, annual distribution to infection-prevention and medical staff, reporting of unit-specific susceptibilities, exclusion of duplicate isolates, reporting of temporal trends in susceptibilities, and reporting of susceptibility separately for different anatomical sites of culture (e.g., blood and urine).8

Studies have shown that a great deal of variability exists among clinical laboratories in their reporting structures; however, these structures consistently show a similar positive impact of providing valuable information as the lab's ability to more rapidly identify emerging patterns of resistance is enhanced.8 Communication of this data and analysis from the laboratory to the pharmacy, along with the physicians and clinical staff, will contribute to the evolving development of antimicrobial-use guidelines that aid in controlling the incidence and emergence of HAIs.

Act 3, Scene 2: Vital communication
Clear and effective communication is imperative to healthcare workers' ability to improve patient health as well as their own ability to emulate best clinical practice. There are basic principles behind effective communication: Keep the message and language simple and audience-appropriate; be culturally competent; use multiple communication channels; disseminate information at the right time; and, finally, to be effective, listen.9
Diagnostic programs, standardization of tests, centralized administration, quality control, systems analysis, preparation of statistics for performance analysis, and the regulation of new and obsolete tests all require the delicate balance of clear and effective communication.

Therefore, alert-and-response of the clinical laboratory is as vital a function as the testing, processing, diagnosing, and even preparation of antibiograms. The vast amounts of valuable data generated by the clinical laboratory would be useless if no one ever received the information.7 Workflow of clinical laboratories must carefully include alerts and results of data management.7 Adequate data management, storage, and computing equipment and protocols should allow for automatic alerts of unusual results, in addition to the detection of increased trends.7 The flexibility of this reporting system will help to ensure inclusion of data locally as well as in regional, national, and international databases. A combination of paper-based systems (textual and chart/graph) and electronic systems for reporting and communication of results can be very successful.
The link between clinical lab's information and the doctor's or caregiver's decision making still remains a challenge in regard to the availability of the information at the most appropriate time and also in how the information is used.10 Therefore, clinical laboratories and their resources should communicate vital information to the medical community and also augment analysis of surveillance data, as well as facilitating temporal and spatial analysis of surveillance data that ensures a complete collection of notifiable diseases, and emerging patterns and trends.7

Final Act: A changing landscape
Clinical laboratories are likely one of the most under-utilized resources in the healthcare system from the vantage of their potential impact on healthcare outcomes.10 The advances in laboratory technology will likely aid in shaping the manner in which medicine is practiced, in the effort to use — in the best possible manner — the services clinical laboratories offer.10
Technologies, such as automation and even nanotechnology, are now changing the landscape and capabilities of clinical laboratories.10 Unfortunately, exploitation of various technologies is often hampered by the laboratory's inability to leverage the value of the investment in such technologies because its benefit lies beyond the boundaries of the budgetary silo.10 Further, those key players within the laboratory — the laboratory technologist and microbiologist — are evolving from being analysts in the true sense to becoming experts and engineers responsible for ensuring the maintenance of analytical methods performed by sophisticated analyzers.10

So, how will healthcare manage the challenge and perceive our clinical laboratories. As suppliers of results only? Or more valuably as providers of information and knowledge about results?10 The vision laboratories have of the future, particularly in this environment of HAIs, challenges practitioners to acknowledge present limitations and growing pains but recognize how that future will impact healthcare delivery.10

History has shown that laboratories are plagued by silo management and budgeting mitigating against the best use of these critical resources.10 Breaking down the conventional barriers and the silo barriers while, at the same time, recognizing that the foundation of any service lies within its personnel, each healthcare division must work closely other divisions to globally achieve better health outcomes.10

Can healthcare today rise to the challenge of appreciating the value of the clinical laboratory's investigation to help maximize benefits, minimize risks, and, ultimately, improve efficiency of care in this Zero Tolerance era?

Further reading
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Susan Jukins Hudson, RN, BSN, CIC, LHRM, is a registered nurse licensed in Florida and Connecticut, and is employed by NCH Healthcare System, a 681-bed, two-campus acute-care facility on Florida's West Coast. She has worked in infection prevention and control in the acute-care hospital setting and is board-certified in infection prevention and control, as well as being a Florida-licensed healthcare risk manager.


  1. Bolyard EA, Tablan OC, Williams WW, et al. The Hospital Infection Control Practices Advisory Committee: Guideline for infection control in healthcare personnel, 1998. Accessed October 15, 2010.
  2. World Health Organization: Department of Communicable Disease, Surveillance and Response. Prevention of hospital-acquired infections: A Practical Guide 2nd ed. 2002. Accessed September 2, 2010.
  3. Gordis L. Epidemiology, 3rd ed. Philadelphia, PA: Elsevier Saunders. 2004.
  4. Ducel G, Fabry J, Nicolle L. “Prevention of hospital acquired infections: A Practical Guide,” 2nd ed. 2002. World Health Organization. Accessed September 5, 2010.
  5. Wenzel RP, Edmond MB. The Impact of Hospital-Acquired Bloodstream Infections. Emerg Infect Dis. 2001;7(2);174-177. Accessed September 2, 2010.
  6. Mirza A, Custodio H. Hospital-Acquired Infections. Accessed September 2, 2010.
  7. Canton R. Role of the Microbiology Laboratory in Infectious Disease Surveillance, alert and response. ESCMID. 2005; 11(suppl. 1):3-8.
  8. Lautenbach E, Nachamkin I. Analysis and Presentation of Cumulative Antimicrobial Susceptibility Data (Antibiograms): Substantial Variability Across Medical Centers in the United States. ICHE. 2006;27(4):409-412.
  9. Novick LF, Morrow CB, Mays GP. Public Health Administration: Principles for Population Based Management. Sudbury, MA: Jones and Bartlett Publisher Inc. 2008.
  10. Price CP. Current and Future Challenges for the Hospital Laboratory. Accessed October 15, 2010.
  11. Bhattacharya S. Clinical Microbiology: Should microbiology be a clinical or a laboratory specialty? IJPM. 2010;53(2):217-221.
  12. Association for Professionals in Infection Control (APIC) Text of Infection Control and Epidemiology. Accessed September 2, 2010.


Sepsis poses life-threatening response to infection

By Christopher J. Czura, PhD, and Linda Distlerath, PhD, JD


ctor Christopher Reeves, Pope John Paul II, Muppet-master Jim Henson, and actress Anna Nicole Smith probably shared little in life, but their pathway to death was painfully the same: sepsis. Sepsis, the body's life-threatening response to infection, afflicts nearly 1 million Americans annually, causing more deaths yearly than prostate cancer, breast cancer, and HIV/AIDS combined, and costs the U.S. healthcare system nearly $17 billion. 1 Experts believe sepsis is the leading cause of death, collectively representing the majority of the mortality associated with HIV/AIDS, malaria, tuberculosis, pneumonia, and other infections acquired in the community, in healthcare settings, or by traumatic injury. Patients are at 10 times greater risk of death from sepsis after surgery than from a heart attack or pulmonary embolism.2

While an estimated 18 million cases of sepsis occur globally each year,3
there is also a lack of patient awareness about sepsis and its mortality rates. More than 80% of the general population in developed nations are unfamiliar with the term sepsis; 35% of Americans who have heard of the term are unable to define sepsis.4 Often, people first learn about sepsis when a loved one has died of complications due to surgery, pneumonia, or a urinary-tract infection that could not be controlled. Sepsis may lead to shock, multiple organ failure, and death especially if not recognized early and treated promptly.

Sepsis occurs more frequently in the young and the elderly; and in many hospitals, sepsis is the leading cause of death in non-coronary intensive-care units. In addition, anti-cancer drugs frequently render oncology patients susceptible to infection, with sepsis a major cause of death in this population. While ICU physicians and nurses know the risk of sepsis in seriously ill patients, healthcare professionals in other settings are often less aware and ill-prepared to recognize and deal with sepsis as a medical emergency.

Confusion exists among both medical professionals and patients with sepsis terminology, but advances in molecular medicine in understanding its pathophysiology is informing its definition and explanation. Sepsis is a systemic immune response to infection that turns against the body with potentially deadly consequences. It is not the infection itself and terms like septicemia, blood poisoning, healthcare-acquired infections, and bacteremia are not equivalent to sepsis or subsets of sepsis. Sepsis occurs when the foreign products of infectious agents (often bacterial, but include viral, fungal, and parasitic) activate the immune system which, in turn, releases cytokines and other mediators into the bloodstream. These mediators produce the major clinical signs and pathophysiological effects in the host that collectively create the sepsis syndrome. Sepsis is the final common pathway to death from infections — no matter what the source or the kind of infectious agent.

If not detected early and treated aggressively, sepsis can spiral quickly into a life-threatening situation. Sepsis is diagnosed based on the presence or suspicion of an infection (bacterial, fungal, or viral) plus one or more of the following: fever, increased respiration rate, increased heart rate, reduced blood pressure, or elevated white blood cell count. Sepsis is considered severe when multiple body organs begin to fail (kidney, heart, and lungs), while septic shock occurs when blood pressure drops to a life-threatening levels.

As previously noted, sepsis is under-recognized and poorly understood worldwide due to confusion about its definition, its lack of documentation as a cause of death on death certificates, inadequate use of diagnostic tools, and inconsistent application of standardized clinical guidelines to treat it as a lethal disease and a medical emergency. Early detection and aggressive treatment of sepsis can prevent the majority of sepsis deaths. Diagnostic tools that can identify sepsis early, and readily available interventions (e.g., fluids and antibiotics), can dramatically alter its course and improve survival if administered within the first hour of suspicion of sepsis.

Over the past year, sepsis experts have coalesced around the need for a global initiative to reduce the mortality of sepsis worldwide. Tackling sepsis as a major medical and public-health problem requires engaging many stakeholders and institutions, including medical societies, research labs, hospitals,and healthcare systems, governments, insurers, biopharmaceutical and diagnostic industries, and patient/consumer advocates. Significant progress is being made in harnessing power, leadership, and resources from the medical, scientific, and advocacy communities. In early October, the Feinstein Institute for Medical Research, research branch of the North Shore-LIJ Health System, hosted the international Merinoff Symposium 2010: SEPSIS, which addressed key issues from scientific, medical, communications, and policy perspectives. One outcome was a “call to action” to governments, healthcare providers, and philanthropic communities to focus on positioning sepsis as a medical emergency.

Christopher J. Czura, PhD is VP-Scientific Affairs for the Feinstein Institute for Medical Research, and Linda Distlerath, PhD, JD, is senior VP of APCO Worldwide, a public affairs and strategic communications firm. For more information about sepsis, visit or, or contact the authors at [email protected] and/or [email protected].



  1. Angus DC, et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001;29:1303-1310.
  2. Moore L, et al. Sepsis in General Surgery. Arch Surg. 2010;145(7):695-700.
  3. Surviving Sepsis Campaign. Accessed at: Accessed on September 28, 2010.
  4. Dellinger RP, et al. An international survey: Public awareness and perception of sepsis. Crit Care Med. Accessed on September 28, 2010.