Hospital Information and Courses from MediaLab, Inc.

American College of Rheumatology, Committee on Rheumatologic Care, Position Statement, Methodology of Testing for Antinuclear Antibodies; Feb, 2009. Available at http://www.rheumatology.org/search/search.asp accessed on June 16, 2010Anuradah V, Chopra A, Sturgess A, Edmonds J. Cost-effective screening method for antinuclear antibody detection. Asian Pacific League of Associations for Rheumatology. 2004(7):13-18.Arbuckle MR, McClain MT, Rubertone MV, et al. Development of autoantibodies before the clinical onset of systemic lupus erythematosus. N Engl J Med. Oct 16 2003;349(16):1526-1533.Bossuyt X, Frans J, Hendrickx A, Godefridis G, Westhovens R, Marien G. Detection of Anti-SSA Antibodies by Indirect Immunofluorescence. Clin Chem. 10 7 2004;50(12):2361-2369.Clinical and Laboratory Standards Institute (formerly NCCLS); Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guidelines - Second Edition. CLSI I/LA2-A2. 2006;26(13).Fritzler MJ, Hanson C, Miller J, Eystathioy T. Specificity of autoantibodies to SS-A/Ro on a transfected and overexpressed human 60 kDa Ro autoantigen substrate. J.Clin.Lab.Anal. 2002;16:103-108.Fritzler MJ, Miller BJ. Detection of autoantibodies to SS-A/Ro by indirect immunofluorescence using a transfected and overexpressed human 60 kD Ro autoantigen in HEp-2 cells. J.Clin.Lab.Anal. 1995;9:218-224.Fritzler MJ, Wall W, Gohill J, Kinsella TD, Humbel RL. The Detection of Autoantibodies on HEp-2 Cells Using an Indirect Immunoperoxidase Kit (Colorzyme®). Diag Immunol. 1986;4:217-221. Keech CL, Howarth S, Coates T, Rischmueller M, McCluskey J, Gordon TP. Rapid and sensitive detection of anti-Ro (SS-A) antibodies by indirect immunofluorescence of 60kDa Ro HEp-2 transfectants. Pathology. 1996;28:54-57.Keech CL, McCluskey J, Gordon TP. Transfection and overexpression of the human 60-kDa Ro/SS-A autoantigen in HEp-2 cells. Clin.Immunol.Immunopathol. 1994;73:146-151.Kroshinsky D, Stone JH, Bloch DB, Sepehr A. Case records of the Massachusetts General Hospital. Case 5-2009. A 47-year-old woman with a rash and numbness and pain in the legs. N Engl J Med. Feb 12 2009;360(7):711-720. McCarty, G.A., Valencia, D.W., and Fritzler, M.J., Antinuclear Antibodies-Contempory Techniques and Clinical Application to Connective Tissue Disease. New York: Oxford University Press, Inc. 1984. Murray DL, Homburger HA, Horvat RT, Snyder MR, College of American Pathologists; S-C 2009: Antinuclear Antibody Screening Methods; CAP Surveys S-C Diagnostic Immunology;2009 Pollock W, Toh BH. Routine immunofluorescence detection of Ro/SS-A autoantibody using HEp-2 cells transfected with human 60 kDa Ro/SS-A. J.Clin.Pathol. 1999;52:684-687.Singer, M. and Berg, P., Genes & Genomes-A Changing Perspective. Mill Valley, CA: University Science Books. 1991.Sullivan KE. The complex Genetic Basis of Systemic Lupus Erythematosus, Reprint from 1999 and 2000; Lupus Foundation, Available at http://www.lupus.org/education/articles/geneticbasis.html Accessed June 16, 2010.Wallace DJ. New methods for antinuclear antibody testing: does it cut costs and corners without jeopardizing clinical reliability? Nat Clin Pract Rheumatol. Aug 2006;2(8):410-411.Willcocks LC, Carr EJ, Niederer HA, et al. A defunctioning polymorphism in FCGR2B is associated with protection against malaria but susceptibility to systemic lupus erythematosus. Proc Natl Acad Sci U S A. Apr 27 2010;107(17):7881-7885.

The focus of this course will be on the technical process of producing human tissue blocks embedded in paraffin wax. Other embedding techniques using various media such as gelatin, ester wax, polyethylene glycol, and epoxy resin are also used in some histological techniques. However, in this course we will be discussing the method of embedding human tissue samples in molten, or melted, paraffin wax. This is the most commonly utilized method for routine tissue embedding and is the method most utilized in nearly all hospital histopathology laboratories for processing human tissue samples for diagnostic interpretation.In the order of events (chronology) of the total histology process, paraffin embedding takes place following tissue processing and prior to and in preparation for microtomy. For proficiency in paraffin embedding, the histologist needs:An understanding of basic anatomy for use in tissue type orientationKnowledge of basic tissue sampling methods used in gross dissectionTo develop manual dexterity and spatial reasoning in order to correctly orient the specimen in the tissue block for microtomyThis course will introduce and review some of the essential background information needed for correct embedding technique. Also discussed in this course will be guidelines for orientation of common histology specimens. Mastery of this information facilitates practice and application of these concepts during execution, to increase the histologist's technical proficiency at paraffin embedding in the histology laboratory.

The medical laboratory industry has become more competitive in recent years due to cuts in reimbursement, more restrictive regulatory requirements, increased competition in outreach, and increased cost of labor and materials. This has significantly affected the bottom line of both hospital and reference laboratories. In order to stay competitive, laboratories must be able to meet the needs of their customers at a reasonable cost. This transition has led to more laboratories utilizing Lean and Six Sigma to achieve customer satisfaction and improve finances.The National Institute of Standards and Technology (NIST) Manufacturing Extension Partnership defines Lean as:"A systematic approach to identifying and eliminating waste (non-value added activities) through continuous improvement by having the product flow towards the pull of the customer in pursuit of perfection." *Six Sigma is a quality improvement method that strives to prevent defects. Six Sigma quality performance means no more than 3.4 defects per million opportunities. The methodology emphasizes the DMAIC approach to quality improvement and problem solving.Lean and Six Sigma are complementary concepts. Both Lean and Six Sigma focus on process improvement. While Lean focuses on reducing waste, Six Sigma focuses on reducing variation. By eliminating both waste and variation, you will approach a defect-free process.*Reference:Czarnecki H, Loyd N. (2002). Simulation of lean assembly line for high volume manufacturing. Center for Automation and Robotics, University of Alabama in Huntsville. Available at: www.scs.org/confernc/hsc/hsc02/hsc/papers/hsc037.pdf. Accessed January 30, 2012.

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.

Garbutt JM. Littenberg B. Evanoff BA. Sahm D. Mundy LM. Enteric carriage of vancomycin-resistant Enterococcus faecium in patients tested for Clostridium difficile. Infection Control & Hospital Epidemiology. 20(10):664-70, 1999 OBJECTIVE: To identify independent risk factors for enteric carriage of vancomycin-resistant Enterococcus faecium (VREF) in hospitalized patients tested for Clostridium difficile toxin. PATIENTS: Convenience sample of 215 adult inpatients who had stool tested for C. difficile between January 29 and February 25, 1996. RESULTS: 41 (19%) of 215 patients had enteric carriage of VREF. Five independent risk factors for enteric VREF were identified: (1) history of prior C. difficile infection, (2) parenteral treatment with vancomycin for > or = 5 days, (3) treatment with antimicrobials effective against gram-negative organisms, (4) admission from another institution, and (5) age > 60 years. These risk factors for enteric VREF were independent of the patient's current C. difficile status. CONCLUSIONS: Antimicrobial exposures are the most important modifiable independent risk factors for enteric carriage of VREF in hospitalized patients tested for C. difficile.

Francois P. Vaudaux P. Foster TJ. Lew DP.: Host-bacteria interactions in foreign body infections. Infection Control & Hospital Epidemiology. 17:514-20, 1996 Persistent staphylococcal infections are a major medical problem, especially when they occur on implanted materials or intravascular catheters. This review describes some of the recently discovered molecular mechanisms of Staphylococcus aureus attachment to host proteins coating biomedical implants. These interactions involve specific surface proteins, called bacterial adhesins, that recognize specific domains of host proteins deposited on indwelling devices, such as fibronectin, fibrinogen, or fibrin. Elucidation of molecular mechanisms of S. aureus adhesion to the different host proteins may lead to the development of specific inhibitors blocking attachment of S. aureus, which may decrease the risk of bacterial colonization of indwelling devices.

The cerebrospinal fluid sample should be properly labeled with the tube number, patient's name and hospital number or other unique identifier. The samples should be transported to the laboratory immediately.

The Non-Federally Regulated Custody and Control Form is most often used in clinics and hospital emergency rooms when drug abuse is suspected, or by companies participating in their state's drug-free workplace program. Be aware that some states mandate the use of a special CCF for their drug-free workplace program. There are significant differences between the Federally Regulated CCF and the Non-Regulated CCF. You are strongly encouraged to review the difference between the two. Unless there are extenuating (which we will discuss next), remember that the two forms are not interchangeable. The Federally Regulated CCF can be used only for urine collections required by the Department of Transportation drug testing program.

Patient safety when performing a capillary blood collection includes positive patient identification prior to performing the procedure. The accepted policy in most healthcare facilities is to use two forms of identification, including a unique number if possible, such as a hospital number or medical record number.Ideally, the patient (or the parent/guardian if the patient is a small child) should be asked to spell his/her name and state his/her date of birth. This may not always be possible, but it will aid in positive patient identification whenever it can be done.The phlebotomist should LOOK at the patient's paperwork while they LISTEN to the patient's response. For inpatients, the patient identification bracelet, which must be attached to the patient's wrist or ankle, should be used to verify patient identity. A hospital number recorded on the bracelet may be used as a second identifier in the case of an inpatient.Paying close attention to these details and correcting any discrepancy discovered will greatly reduce the risk of misidentifying a patient. Always follow the policy of your facility for identification and never shortcut the patient identification procedure.

Here are the criteria for the preparation of tables, as specified by the Journal of Clinical Laboratory Science:Write table titles at the top of the table. Number tables sequentially with Roman numerals. Include the following information in a title, whenever possible: who, what, where, why and when. Put the independent variable in the left column, and the dependent variable in the right, if you are listing data with independent and dependent variables. Label each column with the appropriate units. Adequately space tables that appear on the same page. Example:Table I Patient specimens analyzed for blood urea nitrogen on the Dimension RxL and the Vitros 250 at City HospitalSample #RxL (mg/dL urea)Vitros 250 (mg/dl) urea18.88.8211.210.0312.413.6416.213.2520.021.2625.020.0728.826.2In this case, the Dimension RxL is the "reference method" and is considered the independent variable, while the Vitros 250 is the "test method" and is considered the dependent variable.

Relative frequency is the proportion of a sample that belongs to a particular class. We calculate the relative frequency by dividing the class frequency by the total number of data points, n. The sum of the relative frequencies should be one, but due to rounding errors, sometimes it is not exactly one.Table IV Actual and Relative Frequency of Serum Glucose Levels in 130 Hospital Employees Intervals (mg/dL) Tally Frequency Relative Frequency 65 - 70 \\ 2 0.015 70 - 75 \\\\ \\ 7 0.054 75 - 80 \\\\ \\\\ \ 16 0.123 80 - 85 \\\\ \\\\ \\\\ \\\\ \\\\ \\\\ \ 31 0.238 85 - 90 \\\\ \\\\ \\\\ \\\\ \\\\ 24 0.185 90 - 95 \\\\ \\\\ \\\\ \\\ 18 0.138 95 - 100 \\\\ \\\\ \\\ 13 0.100 100 - 105 \\\\ \\\\ 10 0.077 105 - 110 \\\\ 5 0.038 110 - 115 \\\\ 4 0.031 Total n = 130 0.999

Histograms are used for continuous or discrete data. When continuous data are charted, you can connect the midpoints of the tops of the bars with a dashed line.Figure 4Frequency of Serum Glucose Levels in 130 Hospital Employees

You also have the choice of plotting the relative or the absolute frequency along the y-axis. The relative frequency is better for large samples. The shape of the graphs, however, is the same for both methods. Figure 6 Absolute Frequency of Serum Glucose Levels in 130 Hospital Employees Figure 7 Relative Frequency of Serum Glucose Levels in 130 Hospital Employees

A large number of assays related to carbohydrate management and diabetes monitoring are performed in clinical laboratories, hospital nursing units, nursing homes, physician offices, clinics, and by patients at home, school, or work.Assays that will be discussed are: Blood Glucose Urine Glucose Ketones Microalbuminuria Insulin and C-Peptide Insulin Antibodies Glycosylated Proteins

Even though most diabetics, physician offices, clinics, nursing homes, and nursing units use glucose meters for monitoring glucose levels, the laboratory's role in diagnosis is vital. The function of the laboratory is crucial in diagnosis, monitoring, and management of diabetes. Diabetic patients can go into severe metabolic imbalances that are life threatening. These metabolic conditions include: diabetic ketoacidosis, hyperosmolar nonketotic coma, and hypoglycemia. Laboratory testing is essential in diagnosing and monitoring these conditions.Laboratory blood glucose and HbA1C levels are used to demonstrate the level of hyperglycemia required for diagnosis. If an OGTT is needed for classification or characterization of hyperglycemia, a patient is sent to a hospital or clinical laboratory for the test. Detection of elevated microalbumin levels that can signal early stages of renal impairment is accomplished through laboratory testing. There are many other disease states and complications associated with diabetes. Clinical laboratories detect these diseases and monitor the complications that result. Important among these assays are urea, creatinine, and serum lipids. If a diabetic does have a pancreatic transplant, serum C-peptide and insulins levels monitor transplant success and viability of transplanted organ.

Risk markers are first hypothesized and then tested. Once a potential marker is identified, concentrations of the serum marker are correlated with patient outcomes. Cardiovascular risk marker studies are typically either retrospective or prospective epidemiology studies. A retrospective study looks backwards at a patient population. For example, we identify (through a hospital database perhaps) patients who have had myocardial infarcts or some other adverse outcome as well as similar subjects without that outcome to use as controls. We then go back and find archived patient serum samples and relate the concentrations of our new risk marker with patient outcomes. Retrospective studies can only be performed if you have archived samples from the patient. Prospective studies look forward in time. For example, we first select a group of subjects and measure our new risk marker in these patients over time. After a few years, we see how the serum concentrations relate to the patient outcomes. Obviously, prospective studies take much longer to perform than retrospective studies. Whatever study model is used, when assessing the value of a cardiovascular risk marker, we must correlate serum concentrations with a specific outcome. The outcome is determined by the study authors. Outcomes could be things like myocardial infarction, stroke, a diagnosis of coronary artery disease, death, or any cardiovascular 'event.'Concentrations of risk markers are divided into tertiles, quatriles or quintiles. This simply means that the top 33%, top 25% or top 20% of the serum concentration values are compared to the bottom 33%, 25% or 20%. For example, risk marker studies will often compare the outcomes of patients with serum concentrations in the upper tertile (those in the top third) with those in the bottom tertile (those in the bottom third) to see if the top 33% had significantly worse outcomes; if so, the risk marker has clinical value.

Phlebotomy is considered the treatment of choice for patients with iron overload due to hereditary hemochromatosis (HH). Each unit of blood contains approximately 200 to 250 mg of iron. As erythrocytes are removed by phlebotomy, iron stores are mobilized and utilized in the production of new, circulating erythrocytes. Through periodic phlebotomies, stored iron is removed until iron-deficient erythropoiesis is induced. The initial, or iron reduction, phase of treatment typically consists of removing one unit (450 mL) of whole blood once or twice weekly. Prior to beginning phlebotomy, the patient's hemoglobin and hematocrit must be checked to ensure that the patient is not anemic. A sample for serum ferritin is also collected at this time.Initial treatment goals include inducing iron deficient hematopoiesis without the development of debilitating symptoms of anemia. A hemoglobin concentration of 10.0 to 12.0 g/dL is often used as a target range. The initial treatment phase continues until excess stored iron is removed and ferritin levels decrease to approximately 50 ng/mL. (13) Ferritin and hemoglobin levels are periodically monitored during this phase. The number of phlebotomies needed to reduce iron levels and induce anemia is related to the degree of initial iron overload. Patients may be referred to a hematologist or gastroenterologist during the initial treatment phase. Many patients receive therapeutic phlebotomy services in a hospital or doctor's office, but patients may also undergo phlebotomy at a blood center. Blood collected from persons with HH may be used for transfusion or as blood products if it has been collected from a facility with an approved variance from the US Food and Drug Administration. Not all blood centers have applied for or been granted this variance.(14)The initial treatment phase continues until excess stored iron is removed and ferritin levels decrease to approximately 50 ng/mL. Removal of excess stored iron may take from one month to three years.

The LRN is a multilevel system designed to link frontline clinical microbiology laboratories and hospitals and other institutions to state and local public health laboratories in supporting advanced capacity public health, military, veterinary, agricultural, water and food testing laboratories at the federal level. Laboratories within the LRN are divided into 3 levels: Sentinel Labs, Reference Labs, and National Labs.

 As the term suggests, Terrorists excel at creating panic. What is so insidious about chemical and biological terrorism is that it involves agents that we can’t see. People don’t know how to react when they can’t see what is hurting them. There are several examples, from a commercial bus crash to someone who reported smelling gas in a school, where rumors that the incidents were caused by either biological or chemical terrorism triggered an “epidemic hysteria”. In both areas the local hospital’s emergency room was overwhelmed. In each of the incidents mentioned, State and Federal officials spent countless hours investigating and found no possible biohazard, but the panic was real. From these experiences we see more than ever that healthcare workers are not just the first line of defense in the event of an actual attack, they are who the public looks to for rationality and reliable information in an bioterrorism emergency.

Cornell University. CUErgo. Available at: http://ergo.human.cornell.edu/ Accessed August 4, 2011.National Institute for Occupational Safety and Health. Ergonomics and musculoskeletal disorders. Available at: http://www.cdc.gov/niosh/topics/ergonomics/ Accessed August 4, 2011.UCLA Ergonomics. Musculoskeletal disorders: Anatomy of an injury. Available at: http://ergonomics.ucla.edu/MSD_Anatomy.html. Accessed August 4, 2011.US Department of Labor. Healthcare wide hazards module: Ergonomics. Available at: http://www.osha.gov/SLTC/etools/hospital/hazards/ergo/ergo.html Accessed August 4, 2011.

Offering or taking a bribe, kickback, bonus, commission, or inducement is against the rules of the Board and against the law. Many companies give away small promotional items, such as pens or note pads, to promote their products. This is legal, but be cautious about accepting more valuable items. This could be seen as a bribe. All of the following are serious violations of Board, state, and federal rules:Participating in any commissions, bonuses, kickbacks, inducements, or split-fee arrangements from physicians, health care providers, suppliers, hospitals, nursing homes, other clinical laboratories, pharmacies, and other facilities.Exploiting or influencing a patient for financial gain, including promoting, selling, or withholding services, drugs, or referrals.

Insurance industry analysis of data from 1985 through 2003 shows that about two thirds of medical errors occur in hospitals and about one third occur in physician offices. About half of hospital errors occur in operating rooms and one sixth occur in patient rooms. Wherever medical errors occur, laboratory professionals can be involved.

Errors also occur after analyses are completed and reported. Postanalytic errors begin with the medical professionals who receive test results, and they include interpretation of the results. These errors can occur at--the bedside, chair-side, hospital, clinic-- wherever the patient and the medical professional are located. The possibility for postanalytic medical error continues through diagnosis and treatment procedures and processes. These medical errors occur during the time after the laboratory reports test results. Examples: Wrong test value associated with patient Wrong test interpretation Wrong diagnosis Wrong treatmentLaboratory professionals might believe they are not associated with postanalytic medical errors, but they can be. One deadly example is fatal hemolytic transfusion reaction involving laboratory error.

The setting is the cafeteria in a hospital or the lounge in an independent laboratory. Two employees, a billing clerk and a medical technologist, from different departments are having lunch together. The billing clerk mentions that she saw a bill go through the system for one of her coworkers for a biopsy. She asks the medical technologist if she has the necessary security level access to see pathology test results because she is concerned about the welfare of the coworker. The medical technologist does have the necessary security clearance to see the results. She should:Correct Answer: Refuse to look up the results for the clerk and remind the clerk that it is a violation of compliance policies to do so, or to ask another to do so. Discussion: The medical technologist has a responsibility to report violations of compliance policies and the friend has put her in a difficult position. For that reason, it is not enough to just refuse the clerk's request. If the medical technologist does not take the responsibility to inform the employee of the policy then there is a possibility that the employee would ask some other employee to do it for her.

Laboratories must not induce physicians to order unnecessary tests through their marketing or education activities: They must monitor the use of laboratory services by their clients. They must correct any situation where something they did caused an unnecessary increase in test utilization. Cost Reports Hospital laboratories must ensure that information used in hospital Medicare cost reports is accurate and includes only those costs which are appropriate. Laboratories must follow all CLIA and OSHA regulations: failure to do so may result in a False Claims Act violation.

Laboratories must not induce physicians to order unnecessary tests through their marketing or education activities: They must monitor the use of laboratory services by their clients. They must correct any situation where something they did caused an unnecessary increase in test utilization. Cost Reports Hospitals laboratories must ensure that information used in hospital Medicare cost reports is accurate and includes only those costs which are appropriate. Laboratories must follow all CLIA and OSHA regulations: failure to do so may result in a False Claims Act violation.

The setting is automated chemistry department, night shift, busy core laboratory for a hospital based outreach laboratory. A medical technologist who operates the automated chemistry analyzer on third shift encounters short samples a couple of times a night. When this happens, he runs as many of the ordered tests as he can and fills in the blank results with a comment indicating that a short sample occurred. As far as he knows there isn't a policy that addresses this problem directly.The test reports out with the results and the comments. The technologist does not have to change the physician order in any way and is providing the maximum results that can be reported for the specimen in a timely fashion. This is done as a matter of patient care and quality service. There has not ever been a complaint about this practice as far as he knows. Are there any additional steps this technologist should be taking?Correct Answer: The technologist should follow the procedures that the laboratory has in place for testing and billing samples for which there is no order or for ambiguous orders. If the policies do not seem to address his particular situation, he thinks there should be a separate policy to cover this situation or has a question about it, he should talk to his supervisor or to the laboratory compliance officerDiscussion: This choice addresses the problem in the most complete manner, in that the employee fulfills his responsibility to take action when he thinks there is a problem.

Busy hospital laboratory in a 350 bed urban hospital that provides laboratory testing for the hospital and for the hospital's outreach testing laboratory. A medical technologist in the microbiology department receives a call from a friend who works in a laboratory in a physician office. The physician is not a regular client of the laboratory currently but uses another laboratory for most of their work. The microbiologist knows that the sales department would like to get this account. The friend explains to her that she is doing a quality control check on her in-office microbiology testing and her regular laboratory will do it but is going to charge her for it. She asks the microbiologist if she will do it for free since it is quality control, not Medicare and is not going to be billed to anyone.She tells the microbiologist that she would like to use the hospital lab for everything but her doctor insists on using the competitor. She indicates that the favor might help get the doctor to try the hospital laboratory for other tests. The microbiologist should:Correct Answer: Explain to her friend that if the hospital does the tests for no charge on the promise of other referrals, both the physician office and the hospital could be liable for violations of the antikickback statute.Discussion: The antikickback statute is implicated in this scenario because the free testing is solicited on the condition that other referrals may occur as a result of providing the favor. In fact, the solicitation itself is a violation of the law. The fact that Medicare patients are not specifically mentioned in the scenario is not sufficient to remove the risk. The technologist should also report the incident to the Compliance Officer and seek advise about what documentation, if any, should be kept concerning the incident.

Staphylococcus aureus, particularly methicillin resistant strains (MRSA), have represented a likely target for molecular development, particularly in blood cultures. As more institutions implement patient screening protocols for MRSA, replacement of routine culture methods with molecular assays has gained increasing attention.PNA-FISH assays provide for the definitive identification of Staphylococcus aureus from positive blood culture vials. Peptide nucleic acid fluorescent in-situ hybridization is a relatively straight forward procedure that does not involve amplification and has limited equipment requirements. Procedurally it is easy to perform with minimal hands on time.PNA is a synthetic imitator of a nucleic acid sequence in which the backbone is a pseudopeptide rather than a sugar. PNA behaves similarly to DNA and will bind to complementary nucleic acid strands. A PNA probe is constructed, utilizing a complementary, hybridizing sequence for a known nucleic acid target sequence. The probe is typically bound to a fluorescent protein as a means of visualizing/detecting the target. In one commercially available method, once a blood culture vial demonstrates gram-positive cocci in clusters, a drop of the blood culture broth is added to fixation solution on a slide. Heat or methanol is used to fix the smear. After fixation, probe that targets species-specific ribosomal RNA is added to the smear, which is then cover-slipped.Slides are then incubated at 55oC. Post incubation, slides are immersed in a preheated wash solution and coverslips gently removed. After incubation in the wash solution, smears are air dried; a drop of mounting medium is added and the slide is cover-slipped again.The slides are examined with a fluorescent microscope, utilizing specific filters. Green fluorescing cocci in clusters are identified as Staphylococcus aureus. This identification would be available, depending on the routine identification system utilized, potentially 24 hours earlier than the norm.A significant number of blood cultures that demonstrate gram-positive cocci in clusters yield coagulase negative staphylococci (CNS), which represent potential contaminants, rather than significant infection. What is the significance of differentiating blood cultures that contain S. aureus from those that are growing CNS in a much earlier timeframe?Studies have shown that IF the differentiation of CNS from S. aureus is effectively communicated to clinicians and pharmacy/antimicrobial stewardship teams, active assessment can occur utilizing defined exclusion criteria for those patients whose cultures yielded CNS rather than S. aureus. In scenarios where contamination rather than infection is indicated, vancomycin can be discontinued earlier, and length of hospital stay is also shortened. Reduced antibiotic exposure, reduced risk of development of resistance, and reduced cost are all potential benefits.

Over the last two decades, bacterial resistance to antibiotics has become widely recognized as a serious problem, making many diseases increasingly difficult if not impossible to treat. Methicillin-resistant Staphylococcus aureus (MRSA) has been present in hospital settings (HA-MRSA) for several decades. More recently, MRSA strains have emerged outside the hospital, in community settings among otherwise healthy individuals. These strains are referred to as community associated-MRSA (CA-MRSA), and they now account for the majority of staphylococcal infections seen in the hospital emergency department or in clinics.

As mentioned in the course introduction, MRSA infections fall into two general types: Healthcare-associated MRSA (HA-MRSA) Infections that occur in people who are, or have recently been, hospitalized. Community-acquired MRSA (CA-MRSA) Infections that are apparently acquired in the community There are a number of factors that distinguish HA-MRSA from CA-MRSA isolates. These factors are summarized in the table below. Factor HA-MRSA CA-MRSA Origin of strains Nosocomial infections Five isolates associated with healthcare settings: USA100, -200, -500, -600, -800 USA100 is the predominant isolate while USA 200 is the second most common isolate. USA700 has been isolated in both healthcare and community settings. Evolved from endemic methicillin susceptible S. aureus (MSSA) strains Two clones, USA300 and USA400, are associated with the majority of CA-MRSA infections in the United States. USA300 has emerged as the most prominent clone and is not found among hospital strains. Genetic lineage Isolates usually carry large SCCmec types I, II or III (34-67 kb) The larger size of SCCmecII and III permits the inclusion of other non-beta lactam resistance genes so that HA-MRSA strains tend to be multi-drug resistant Isolates carry a smaller SCCmec variant, predominantly type IV (24 kb), less often type V or variant VT. SCCmecIV (except for mecA) does not permit the inclusion of other non-beta lactam resistance genes so that CA-MRSA isolates exhibit resistance to only methicillin and erythromycin and are more often susceptible to other non-beta lactam antibiotics (eg., trimethoprim/sulfamethoxazole (SXT) and clindamycin). Affected population Largely affects older adults and people with weakened immune systems; those who have undergone surgical procedures are at increased risk. Healthy persons in the general population without established risk factors for MRSA acquisition Clinical syndromes Found at multiple sites, most commonly bloodstream infections, urinary tract infections (UTI) and respiratory tract infections Predominantly skin and soft tissue infections (SSTIs), such as abscesses, cellulitis, folliculitis and impetigo and a serious form of pneumonia Genes for Panton-Valentine Leukocidin (PVL) are associated with SCCmecIV; the clinical spectrum of infections caused by CA-MRSA is directly related to the presence of PVL genes, coding for the production of a cytotoxin that causes tissue necrosis and leukocyte destruction.

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

Clostridium difficile-associated diarrhea (CDAD) is a unique hospital infection that occurs almost entirely in patients who have received previous antimicrobial treatment. Anaerobic gut flora are crucial to colonization resistance, so any disruption of the normal colonic flora (through illness, therapeutic procedures or, most commonly, antibiotic use) is essential to the pathogenesis of C. difficile infection. The association of CDAD with antibiotic use is significant. Early attention (1970s) focused on clindamycin but later on (1980s,1990s & continuing today) the cephalosporins, especially third generation, and broad spectrum penicillins (e.g., amoxycillin/ampicillin) were also implicated. The risk of CDAD is increased if C. difficile is resistant to the particular antimicrobial. In the case of clindamycin, C. difficile resistance is variable. Risk of infection due to a clindamycin-resistant strain increases with use of the drug. For the third generation cephalosporins, C. difficile is universally resistant; thus, any toxigenic strain is capable of causing CDAD during cephalosporin use. Other less commonly implicated antibiotics are the macrolides, e.g., erythromycin, azithromycin, clarithromycin. However, prolonged courses of any antibiotics will increase the risk of disease. Even those antibiotics used to treat colitis (metronidazole, for example) have sometimes been reported to cause CDAD.The fluoroquinolones have been in use since the 1980s. Ciprofloxacin was approved in 1987, but it is only in recent years with the emergence of the epidemic strain 027/NAP1/BI, which is resistant to the fluoroquinolones, that this class of drugs has been implicated in Clostridium difficile disease. The fluoroquinolones were initially considered to be low risk but their use has been increasing, both with hospital inpatients and in the community, and fluoroquinolones are now implicated as a risk factor for C. difficile infection. The newer fluoroquinolones, e.g., gatifloxacin, moxifloxacin, have better activity against anaerobes, but poor in vitro activity against C. difficile, thus increasing the likelihood of CDAD. The CDC now recommends that all fluoroquinolones, as a class, be used sparingly as each poses an increased risk for CDAD.

Enterococci are largely commensal organisms that are opportunistic pathogens. Underlying disease, an immunocompromised state, age, lengthy hospital stays or long term care, invasive treatments, and/or prior antimicrobial therapy are factors that are associated with significant infections with these species. As noted previously, Enterococci are intrinsically resistant to many antibiotics. Intrinsic resistance affects not only beta lactams (including a broad range of cepahlosporins) and aminoglycosides, but also clindamycin and trimethoprim/sulfamethoxazole. The standard recommended therapy for systemic infections is a combination of either penicillin or vancomycin and an aminoglycoside (gentamicin or streptomycin). The goal of combination therapy is to achieve a synergistic bacteriocidal effect between the cell wall agent and the aminoglycoside.In recent decades, increasing resistance to other antibiotics through acquired resistance mechanisms has become a growing therapeutic and infection control problem. Of key concern are high level resistance (HLR) to aminoglycosides and increasing resistance to glycopeptides such as vancomycin.

Frequent handwashing is one of the most important measures that you can take to help control the spread of infections. Hands should be washed:As soon as gloves are removed Before and after direct patient contact After using the toilet Before eating or drinking Anytime hands are contaminated Before leaving the work area

Handwashing is the single most important method of infection control and prevention available.It prevents many other community and hospital acquired infections.It is essential in the prevention of bloodborne pathogen transmission.

Julie Smith was a newly certified phlebotomist and had been working at Northwood Hospital for several months. As she approached room 825, she looked on her collection list to verify this was the correct room for her first collection. Indeed it was, even though there was no patient name on the door. Her collection list told her the patient in room 825 was a 55 year old male named John Ready. After knocking several times, Julie entered the room to find a middle aged man who appeared to be sleeping. Julie approached the patient and said, "Good day Mr. Ready. My name is Julie and I am from the lab. I need to draw blood for some tests ordered by your doctor." The man awoke and seemed irritated as Julie repeated herself. The patient responded and told Julie to do whatever she needed to do so he could go back to sleep Julie then proceeded to do the venipuncture.

Marcie Moore was a phlebotomist at a community hospital in Atlanta. It was her week to collect the pediatric unit and she was on her way to the room of a newborn for which she had just received orders to draw a STAT BMP (chem-7) and bilirubin. After informing the mother of the baby about the test she needed to perform, Marcie set up to perform a heel stick on the baby. Marcie chose a site on the outer edge of the heel on the bottom of the baby's foot ( the correct area for a heel stick) and made a small incision with a Tenderfoot lancet after cleaning the site well with alcohol.She immediately began collecting the blood in the correct tube for the BMP and bilirubin. Blood flow was not strong so Marcie squeezed the baby's foot a little to help the blood come out faster – the newborn was screaming and Marcie could tell it was making the mother uncomfortable. She wanted to hurry and get done so the mother could hold the baby.After the chemistry tech ran the blood tests on the tube, she informed Marcie that the newborn had a panic potassium level which did not coincide with the previous blood work on the newborn. Also the chemistry instrument could not perform the bilirubin due to hemolysis. Marcie was asked to recollect the specimen.

John Wagner, a phlebotomist at General Hospital, went up to the 7th floor to draw routine blood work on a patient. As he approached the door of the patient's room he noticed a red stop sign on the door with the words "Respiratory Isolation" written on it.

Julie Smith, a newly certified phlebotomist at Northlake Hospital, entered a patient's room on the third floor for a routine blood draw. The patient was an elderly woman who had very small fragile veins. Julie therefore decided to use a safety butterfly needle attached to a Vacutainer tube in order to draw the blood. When Julie was finished with the venipuncture, she detached the butterfly needle from the Vacutainer, and approached the Biohazard needle disposal box. She noticed that the disposal box was full , but decided to try to fit the butterfly into the box anyway. Holding the butterfly by the tubing, she tried to push the butterfly into the box. The needle suddenly recoiled and stuck Julie's finger. Julie left the patient's room in a panic and headed back to the lab to report the needle stick injury.

A phlebotomist at Memorial Hills Hospital entered the room of a 6 year old patient. The only test ordered was a CBC, so the phlebotomist decided to do a finger stick. After gathering proper supplies for the finger stick, the phlebotomist began the procedure by putting on gloves and wiping the tip and side of the patient's ring finger with alcohol. He positioned the safety lancet between the ball and the side of the finger and made a small incision. The child cried as the blood was collected.

This phlebotomist violated hospital procedures in several ways that could adversely impact patient care: Cleaning the site only with alcohol, not iodine, could result in a false-positive contaminated blood culture. This might result in the patient receiving unnecessary intravenous antibiotics, and could prolong the patients hospital stay unnecessarily. Drawing both cultures at the same time lessens the chance of recovering a bloodstream organism.Drawing both cultures from the same site might result in both of them being contaminated, making it very difficult for the physician to distinguish contamination from a "real" bloodstream infection.Relevant topics:Blood cultures: introduction, Avoid skin contamination, Blood culture site preparation 1, Blood culture site preparation 2

Be alert to signs posted on the hospital room door or above the hospital bed.Such signs may warn you to use appropriate personal protective equipment according to your institution's isolation policies and procedures. Other signs may specify that the left of right arm should be avoided. Patients may also alert you to avoid the use of an arm.

There are many reasons why certain agents would be selected for use in bioterrorist attacks, including the:Ease of availability: Biological pathogens can be obtained from nature, hospital laboratories, and university research facilities. Difficulty to detect: Small quantities can have potentially deadly or incapacitating effects on a susceptible population. Covert use of the agent: Can be spread throughout large areas by natural convection, air, or water currents. Ease in disseminating: Pathogens can be spread through ventilation systems in buildings. Transportation facilities could become part of the dissemination system by carrying biological agents far from their initial source. Psychological impact: Biological WMD’s could possibly have a psychological impact that will go far beyond their actual effect. The very thought of exposure to a biological agent may possibly cause many people to panic. Ability to tie up resources: Some biological agents can be a hazard for lengthy periods. The use of these agents may require tedious, time-consuming, resource-intensive decontamination and monitoring of facilities before they can be returned to service. Difficulty to defend against attack: It is very difficult for civilian government agencies to prepare for biological terrorist incidents. While most civilian agencies have some kind of hazardous material or HAZMAT response teams; in the event of a biological terrorist incident, these teams are likely to be challenged beyond their capability in terms of human resources, and equipment.

Patient A.D., a 30 year old female, was admitted to the hospital in active labor to deliver at 37 weeks gestation. Transfusion service (TS) records showed A.D. to be group O Rh negative with no record of unexpected red cell antibodies.Maternal history showed two prior pregnancies. Her first pregnancy four years ago ended in spontaneous abortion at 9 weeks gestation and she received a mini-dose (50 µg) of RhIg.In the second pregnancy, two years ago, the infant typed as Group A Rh positive, DAT negative. Patient A.D. was injected with RhIg within 72 hours of delivery. The laboratory also confirmed that in the current pregnancy RhIg was administered at approximately 28 weeks gestation subsequent to a negative antibody screen.After many hours of non-productive labor, the physician considered that labor had stalled and decided to do a cesarian section (C-section). According to hospital policy for C-sections, a type and screen was ordered.

In 1999 the Institute of Medicine (IOM) published a study entitled "To Err Is Human: Building a Safer Health System." Its estimate of the number of deaths and adverse outcomes caused by medical errors sent shockwaves throughout the healthcare community as well as the general population. Perhaps for the first time members of the healthcare community began to seriously look at the way healthcare is delivered and how the process could be improved to enhance patient safety.Thus, one of the most beneficial results from the IOM study was that hospital workers and other healthcare providers realized that they urgently needed to fully and more effectively incorporate "risk" as a crucial component of their management.

External assessments performed by hospital and laboratory accrediting agencies can assist health care facilities/laboratories understand where they may need to improve to avoid negative patient outcomes (i.e., manage risk). Since all accreditation programs are voluntary, it is not required that each laboratory become accredited in order to become licensed by their state. Nevertheless, participation in accreditation is viewed as essential to the laboratory's commitment to meeting high standards. In addition, accreditation provides laboratories with benchmarks for maintaining those standards. The three accrediting bodies discussed next have the deeming authority to grant to those laboratories they accredit "deemed" status. This is determined by the Centers for Medicare and Medicaid Services (CMS) as they have met CMS's condition of participation in the Medicare Program. Laboratories with "deemed" status not only meet the requirement for reimbursement from Medicare and certain managed care organizations. The "deemed" laboratories are also not required to undergo Clinical Laboratory Improvement Amendments (CLIA) surveys other than random validation surveys. "Deemed" status, however, does not ordinarily provide an exemption from state requirements for state licensure.

The College of American Pathologists (CAP) is a private, non-profit accrediting organization that has been granted "deeming" authority by CMS. The goal of the CAP laboratory accreditation program is to "Improve patient safety by advancing the quality of pathology and laboratory services through education, standard setting, and ensuring laboratories meet or exceed regulatory requirements." Though CAP inspects only clinical laboratories, there are various types such as: reference laboratories, clinics, military installations, hospital laboratories, etc. which may be accredited through this organization.Surveys are unannounced and the program uses volunteer teams of practicing laboratory professionals as inspectors, or CAP inspection specialists. Inspection specialists are CAP employees who have extensive experience in laboratory medicine. If a hospital is inspected by the Joint Commission and the laboratory chooses to seek CAP accreditation, the CAP inspection is recognized by the Joint Commission so that the laboratory will not be inspected again by the Joint Commission during the hospital inspection. In the fall of 2008 CAP launched a laboratory accreditation program based on the International Organization for Standardization (ISO) 15189:2007. This program utilizes criteria and procedures specifically developed to determine technical competence and account for quality management systems. It does not replace the CAP Laboratory Accreditation Program but is an addition to it. Participation is strictly voluntary and there is no tie to CMS for Medicare reimbursement.The table to the right depicts factors involved in determining technical competence.

In order to prevent errors that affect specimen quality, the phlebotomist must pay close attention to detail during the entire venipuncture process. All steps of the phlebotomy procedure must be included for every venipuncture. This will help to maintain specimen integrity during the collection, transport, and handling of blood specimensProperly identify the patient every timeThe phlebotomist is responsible for correctly identifying the patient using two unique patient identifiers that include the patient's complete first and last name, medical record or hospital number, and/or date of birth. The patient location or room number, bed tag and chart are not reliable forms of identification and should not be used for patient identification. Every patient must verbalize his/her name to the phlebotomist, if able to do so. It is unacceptable for the phlebotomist to ask the patient to confirm his/her name that was verbalized by the phlebotomist. For example, the phlebotomist should say, "Would you please tell me (or spell) your name and birthdate. " The phlebotomist should NOT say, "Are you Sally Brown, and is your birthdate June 1, 1925?" If this is a hospital inpatient, check the information on the patient's wristband and confirm that the name and hospital number or medical record number matches the patient information on the test order. Never rely on identification attached to a bed, chart or door. NEVER draw a patient whose identity is not established or is in conflict. If there is a discrepancy, the phlebotomist must STOP and seek assistance to have the discrepancy resolved before proceeding with the venipuncture. If this is an outpatient that does not have a wristband, ask the patient (or guardian/caregiver) to state the patient's date of birth. A picture ID, such as a driver's license, can also be used for positive patient identification.

Sample integrity is critical to the safety of clinical laboratory services. If there is a problem with the sample, then test results are meaningless. Each time there is a problem with specimen integrity, patients experience wasted time in addition to anxiety and loss of faith in the expertise of the phlebotomy staff. Patients may also experience harm, if harm is defined as delay in diagnosis, therapy, hospital admission or discharge.Threats to sample integrity include:Collection of a sample from the wrong patientCollection of the wrong blood sample (eg, a blue top tube when a green top is needed)Missed venipuncture (multiple attempts)Multiple venipunctures due to improper or inadequate sample collectedMislabeled and unlabeled samplesImproperly performed venipuncture or skin puncture

Case study:You work in a large hospital that specializes in pediatrics. The policy of the facility is to encourage the parent or guardian to remain in the room during venipuncture to comfort the child. You have taken steps to prepare the child for the venipuncture, but the child starts to cry and becomes combative. The mother says that she does not want the test done.Suggested plan of action: Do not proceed if the mother has refused the blood collection for her child. The patient's physician or clinical person in charge of the patient should be contacted and informed of the situation. This may not be something that you would do directly. It may be your facility's policy for you to contact your supervisor.

Mr. R.M., a 55-year old male, was admitted to a hospital emergency department with severe lower gastrointestinal bleeding. His history revealed multiple prior transfusions, the last of which he received five years earlier.Physical examination revealed hemodynamic instability (systolic BP 60 mmHg). Blood tests revealed a hemoglobin (Hb) of 8 g/dL (80 g/L) and a hematocrit (HCT) of 28% (0.28). The patient received aggressive fluid resuscitation with Ringer's lactate and was sent to the operating room (OR) for an emergency laparotomy.The physician ordered four units of Red Blood Cells to be crossmatched.Two units of uncrossmatched group O Rh-negative Red Blood Cells were also ordered and authorized for immediate emergency transfusion.

Delayed HTR often go undetected as the symptoms are usually mild and subclinical (death has occurred, but rarely). Symptoms may not occur until days after transfusion when the patient has left the hospital. Donor red cell destruction is usually by extravascular hemolysis (EVH). Signs and symptoms can include: Fever with or without chills Unexplained drop in hemoglobin and hematocrit Transient jaundice due to elevated serum bilirubin

A variety of tests are available for the detection of influenza A viruses, including the 2009 H1N1 strain. These tests include: rapid antigen tests, direct fluorescent antibody tests to detect the presence of virus in patient specimens, shell vial cell cultures, classical tube cell cultures, and reverse transcriptase PCR (RT-PCR), which detects influenza-specific viral genes. These tests differ in sensitivity, specificity, availability, and the ability to distinguish between different influenza strains and subtypes, such as influenza A 2009 H1N1.The rapid tests, such as the direct rapid antigen tests or immunofluorescence assays, have lower sensitivity and specificity compared to cell culture and the RT-PCR based tests. Rapid tests vary in their ability to detect the 2009 H1N1 virus. The range of sensitivity is 10% to 70% and none of the rapid tests that are currently available are specific for H1N1. However, results of rapid tests are available within 30 minutes to one hour so that a positive test will provide further information toward a diagnosis when it is coupled with a patient's symptoms. A few FDA-cleared RT-PCR kits are available for the detection of influenza A viruses. For the subtyping of influenza A viruses, such as Influenza A seasonal H3N2, and 2009 H1N1, the FDA has given the status of "Emergency Use Authorization" (EUA) to a few of the RT-PCR kits; currently available kits under this emergency status category include those made by the CDC, ELITech, Prodesse, Focus Diagnostics, and Roche. (http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm)State Departments of Health have been provided with RT-PCR kits from the CDC for the subtyping of influenza A viruses. This testing has also been FDA-reviewed and given the status of EUA. State and local health department guidelines determine which specimens should be submitted to public health laboratories for RT-PCR testing. In addition, several commercial reference laboratories, academic labs, and hospital labs have been able to perform influenza A subtyping for 2009 H1N1 under the same EUA status. Any laboratory that performs an EUA method would be required to perform an internal validation process.

Adverse reactions after transfusion of blood components must be evaluated promptly. Most serious reactions occur within the first 15 minutes of starting a transfusion. Continuous monitoring allows reactions to be discovered in a timely manner. The transfusionist must be able to recognize the symptoms of a transfusion reaction and know the appropriate steps to take when one occurs. The first critical step is to stop the transfusion immediately, but keep the patient's line open with saline. The physician should be contacted immediately for instructions regarding patient care. The transfusion service must be notified of the reaction. They will usually provide instructions on proper documentation of the reaction, and the return of any remaining component and/or tubing. The appropriate patient samples are to be sent to the laboratory and usually include blood and urine. The transfusionist must be sure to follow all hospital policies.

A 17-year-old female was admitted to the hospital with abdominal pain and a tentative diagnosis of appendicitis. The total white blood count was 14.5 X 109/L with a left shift and neutrophils with changes tagged by the arrow in the image (see blue arrow). The bluish-staining, blurred accumulations in the cytoplasm (Döhle bodies), are located at the cell periphery in neutrophils with toxic changes.Döhle bodies are remnants of endocytoplasmic reticulum and are products of cytokine activity in the induction and shortened activity of neutrophil activation. They are often present in conditions with increased neutrophil lysosomal activity, manifest as toxic granulation.In this case, the presence of Döhle bodies serves as markers for infection-induced leukocytosis and supports the diagnosis of acute appendicitis.