**2. Genesis of LAS-APS air filtration paradigm**

**1. Introduction**

138 Vignettes in Patient Safety - Volume 4

during the reporting year of 2010 [4].

even result in further economic penalties [6, 7].

In the United States, the Center for Disease Control and Prevention (CDC) estimated that more than 1.7 million people suffer from an infectious complication within the hospital environment annually, representing between 5 and 10% of all admissions [1]. Approximately 99,000 patients afflicted with hospital-acquired infections (HAIs) die each year [2]. The number of estimated patients with an HAI exceeds that of any required reportable disease in the United States, and the number of deaths attributed to HAIs exceeds many of the top ten leading causes of death reported from the US vital statistics [1]. Moreover, the above estimates likely under-represent the true magnitude of the problem due to erroneous reporting and biases inherent to voluntarily reported data.

Apart from the morbidity and mortality associated with HAIs, the estimated healthcare costs range between \$35B and \$88B annually [3]. The most recent Pennsylvania Healthcare Cost Containment Counsel (PHC4) Report indicated that hospitals and Medicare spent approximately \$3B and \$400 M, respectively, toward statewide care of patients affected by HAIs

The Centers for Medicare and Medicaid Services (CMS) announced in August 2007 that Medicare would no longer cover additional costs associated with many preventable errors, including those considered "never events" [5]. The list of events that should never occur in the healthcare setting has now been expanded to encompass 29 unique serious reportable events. HAIs represent one of the 29 unique "never events" that are no longer reimbursable and may

It is estimated that full societal costs associated with HAIs arising in US acute care hospitals amount to approximately \$96–\$147 billion annually [8]. The corresponding per-hospitalization incremental cost ranges between \$17,070 and \$32,176 [8]. Consequently, it can be reasonably extrapolated that a three-room surgical suite, performing 1,000 annual surgeries with a reported 4% infection rate, would realize a cost avoidance savings of between \$171,000 and

Historically, it has been understood that the patient, the healthcare worker, and various surface areas collectively constitute the primary repositories of pathogens responsible for majority of HAIs [9]. To that end, infection control protocols, in-room sterilization techniques, patient preparation, and hand-washing protocols have been implemented in most hospitals and have been helpful in reducing overall HAI rates [10]. Moreover, recent literature suggests that a significant proportion of pathogens responsible for HAIs are airborne [11]. The Aire~HCX™ (LifeAire Systems, Allentown, Pennsylvania) [12] was specifically designed to comprehensively address these airborne pathogens (AP) as they are inherently generated during routine clinical operations. In environments where Aire~HCX™ is employed, infectious APs are remediated in both the supply and return air before entering the clinical space.

The LifeAire Systems' advanced air purification technology (LAS-APS) exceeds the limitations associated with commonly utilized mechanisms of air filtration [13]. Many in-room sterilization technologies require that the clinical space be vacated before use, leading to temporary loss of functional space. The in-room approaches also provide a "static" clean at the exact time

\$322,000 per year specific to the surgical suite with only a 1% decline in HAI rates.

With more than a decade of clinical research into the critical role of ambient air quality, the principal investigator (KCW) designed, tested, and patented their transformational air purification technology [12, 13]. This work revealed that one of the key factors impacting successful clinical outcomes was that of the ambient air. Current standards and guidelines as stated are inadequate to provide ambient air optimal for the clinical and patient setting. The clinical environment is impacted by events both external and internal to the space in question. The research highlighted the significant contribution made by patients, healthcare workers, and various clinical processes [20]. External environmental events, even those outside of the immediate proximity of a clinical space, were also found to greatly impact positive outcomes [21–28]. By removing airborne chemical and biological pathogens to below-detection levels, the LAS-APS provides unprecedented control over air quality and significant positive impact on clinical outcomes [25–28].

The LAS-APS provides extremely high levels of filtration as it was designed to kill the anthrax spore (e.g., the most difficult biological pathogen to kill) [29]. The technology used in LAS-APSpatented technology has been tested by the National Homeland Security Research Center and by other third parties. Results indicate that the system renders a broad spectrum of pathogens inert and that it virtually eliminates threatening biological pathogens and volatile organic chemicals from the air—to a level of effectiveness not previously commercially available. Because of its effectiveness toward *Bacillus anthracis*, the LifeAire Systems is able to remediate airborne pathogens such as *Clostridium difficile*, *Aspergillus*, *Streptococcus*, *Pseudomonas*, Staphylococcus (including methicillin-resistant variety), smallpox virus, *Mycobacterium tuberculosis*, influenza virus, etc., each representing a consistent threat to both the hospital environment and rates of HAIs [unpublished data].

Each of the rooms underwent comprehensive evaluation for airborne and surface viable bacterial, fungal, and VOC loads. Three commonly touched patient surfaces and two commonly touched clinical surfaces were evaluated per testing assay (**Tables 2** and **3**). In addition, the final diffuser providing supply air to the patient room and the return vents were swabbed for

Comprehensive and Live Air Purification as a Key Environmental, Clinical, and Patient Safety Factor…

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viable bacteria and fungi (**Table 4**).

**Figure 2.** Schematic representing LSAR and MIXED zones, respectively.

**Figure 3.** Schematic representation of HVAC layout of the MIXED and LSAR zones.
