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It is critical that the right data are measured. If this does not occur, any improvement effort would likely fail. The team would ideally measure variables that will have a direct impact on the outputs. In choosing the type of data to collect, one should consider the time/cost of data collection, how those data tie into customer expectations, and the ability to obtain accurate data. After a decision is made by the team on what to measure, the team also needs to provide an operational definition, the source of data (eg, LIS, log book), prepare a plan, and refine the process as needed. The operational definition is especially important when multiple people are involved in data collection. In the earlier example regarding chemistry stat turnaround time, "received" in the lab could be defined in multiple ways. Some laboratories would define the "received time" as the time the sample physically arrived in the lab (via courier or pneumatic tube) but some might define it as the time the sample is accessioned in the LIS. The team would then proceed to write up a data collection plan. Ideally, the time period of data gathering should be reflective of the normal workflow of the laboratory. A time period that includes major holidays (Thanksgiving, Christmas and New Year), or is at the peak of an outbreak (eg, H1N1 virus) or during student summer vacation, if this is a CLS teaching laboratory, might not be reflective of the normal operation of the laboratory and will lead to skewed results. The period of time to measure will vary depending on the project scope and the resources that are available. Generally 2-3 weeks of data should be sufficient.

Podschun R. Ullmann U.: Klebsiella spp. as nosocomial pathogens: epidemiology, taxonomy, typing methods, and pathogenicity factors Clinical Microbiology Reviews. 11(4):589-603, 1998 Bacteria belonging to the genus Klebsiella frequently cause human nosocomial infections. In particular, the medically most important Klebsiella species, Klebsiella pneumoniae, accounts for a significant proportion of hospital-acquired urinary tract infections, pneumonia, septicemias, and soft tissue infections. The principal pathogenic reservoirs for transmission of Klebsiella are the gastrointestinal tract and the hands of hospital personnel. Because of their ability to spread rapidly in the hospital environment, these bacteria tend to cause nosocomial outbreaks. Hospital outbreaks of multidrug-resistant Klebsiella species, especially those in neonatal wards, are often caused by new types of strains, the so-called extended-spectrum-beta-lactamase (ESBL) producers The incidence of ESBL-producing strains among clinical Klebsiella isolates has been steadily increasing over the past years. The resulting limitations on the therapeutic options demand new measures for the management of Klebsiella hospital infections. While the different typing methods are useful epidemiological tools for infection control, recent findings about Klebsiella virulence factors have provided new insights into the pathogenic strategies of these bacteria. Klebsiella pathogenicity factors such as capsules or lipopolysaccharides are presently considered to be promising candidates for vaccination efforts that may serve as immunological infection control measures.

Cunningham MW.: Pathogenesis of group A streptococcal infections. Clinical Microbiology Reviews. 13):470-511, 2000 Group A streptococci are model extracellular gram-positive pathogens responsible for pharyngitis, impetigo, rheumatic fever, and acute glomerulonephritis. A resurgence of invasive streptococcal diseases and rheumatic fever has appeared in outbreaks over the past 10 years, with a predominant M1 serotype as well as others identified with the outbreaks. Emm (M protein) gene sequencing has changed serotyping, and new virulence genes and new virulence regulatory networks have been defined. The emm gene superfamily has expanded to include antiphagocytic molecules and immunoglobulin-binding proteins with common structural features. At least nine superantigens have been characterized, all of which may contribute to toxic streptococcal syndrome. An emerging theme is the dichotomy between skin and throat strains in their epidemiology and genetic makeup. Eleven adhesions have been reported, and surface plasmin-binding proteins have been defined. The strong resistance of the group A streptococcus to phagocytosis is related to factor H and fibrinogen binding by M protein and to disarming complement component C5a by the C5a peptidase. Molecular mimicry appears to play a role in autoimmune mechanisms involved in rheumatic fever, while nephritis strain-associated proteins may lead to immune-mediated acute glomerulonephritis. Vaccine strategies have focused on recombinant M protein and C5a peptidase vaccines, and mucosal vaccine delivery systems are under investigation.

C. difficile spores resist dessication for months and are known to persist on hard surfaces for up to 5 months. Spores persist even after exposure to air. Epidemic strain B1/NAP1/027 is known to hyper-sporulate, a virulence-associated characteristic of outbreak strains. Healthcare workers are an important vector for transmission as they may carry the spores on their hands or clothing. Alcohol-based hand sanitizers are very effective against non-sporulating organisms but do not kill C. difficile spores or remove the organism from the hands. The CDC recommends thorough hand washing using soap and water for care givers and family members alike.Patients with C. difficile infection (CDI) should be isolated to a single room with a bathroom or cohorted (roomed) together. Staff treating infected patients should use PPE (gowns & gloves) and wash hands after removing gloves. The use of gowns helps to prevent contamination of clothing. Surfaces should be decontaminated using a solution of 10% sodium hypochlorite (bleach), this is effective in reducing environmental contamination in hospital rooms. The CDC recommends the use of bleach for cleaning patient and staff rooms during outbreaks. Control strategies involving reinforcement of Infection control practices rather than drug restriction are more effective. These practices include: Proper education of staff members involved in care of CDI patients Better isolation compliance Use of gloves Frequent and thorough hand washing Environmental decontamination

Anthrax (B. anthracis): Inhalation of anthrax spores is virtually 100% fatal Spores can remain infectious for decadesBotulism: Most lethal toxic agent known Toxin could be used to contaminate food supplies Can be aerosolized in enclosed areasPneumonic Plague (Y. pestis): Aerosolized in large amounts Short incubation period, usually in less than three days, and invariably fatal without early and effective antimicrobial therapy Untreated, fatality rate exceeds 90% Disease is spread from direct exposure to respiratory droplets of infected humansSmallpox: Highly contagious and deliberate spread by aerosol is extremely infectious Mass panic would be createdTularemia (F. tularensis): Highly contagious and easily spread An aerosol containing as few as 25 organisms can cause infection Easily penetrates the smallest breaks in the skinViral Hemorrhagic Fever: Causes internal and external bleeding and would likely cause great panic and easily spread by direct contact with body fluids or respiratory droplets Outbreak due to bioterrorist attack could lead to mass illness and death

Because real-time PCR can amplify extremely small amounts of genetic material, it can be used to detect and identify minute numbers of microbes in a specimen or in the environment. It can even be used to detect DNA of microorganisms that are nonviable or difficult to grow in culture. Before PCR and other amplification methods, microbes had to be cultured in order to obtain enough genetic material to analyze. Thus, dead microorganisms were almost impossible to identify. Cloning for microbial DNA was the method generally used to garner genetic material from microbes that were hard to grow; this process can be extremely lengthy and time consuming. The use of PCR creates a fast and practical way to replicate microbial genetic material, whether alive or dead. PCR is also commonly used for microbial fingerprinting in outbreak investigations as a way to confirm transmission or find the outbreak source. One can look for repeats in the genetic sequences by amplifying random polymorphic DNA, yielding PCR products of various sizes. These products can then be run through an electrophoresis gel, creating a band pattern that is known as the DNA fingerprint. PCR can also be used to fingerprint an entire microbial community in lieu of a specific organism. A community fingerprint is created by amplifying a sequence that is found in all organisms of interest. Community fingerprints can be compared over time to identify stability and variations. PCR has an advantage over culture techniques due to the differences in growth requirements and growth time. With cultures, it is common to miss organisms and determine relative abundance and frequency.

The CDC not only monitors the influenza A 2009 H1N1 virus, but also provides guidance to physicians, public health/healthcare employees, and the general public. The CDC also ensures that there are sufficient quantities of medicines and medical supplies in the event of a public health emergency. The branch in charge of stockpiling and dispersing these supplies is called the Strategic National Stockpile or SNS, which is a division of the CDC. During the outbreak of the H1N1 virus, the SNS dispersed antiviral drugs and respiratory protection devices and other personal protective equipment (PPE) across the United States as well as U.S. territories to assist in the response to the Influenza A 2009 H1N1 virus.