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© National Certification Corporation (NCC) 2009 National Certification Corporation Chicago, IL NOVEL INFLUENZA 2009 (H1N1) NOTE: The following document reflects current knowledge of the 2009 H1N1 Influenza Pandemic in the United States, based on data released by the Centers for Disease Control, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists. It is intended to aid in assessing and managing patients and is not intended to represent standards of care or practice protocols. “Variations in practice may be warranted based on the needs of individual patient, resources and limitations unique to the institution or type of practice” (ACOG, Oct 15, 2009). Therefore these recommendations are considered interim guidance and are subject to revision as newer data become available. Users are strongly advised to consult CDC, ACOG, and AAP websites and publications as well as local and state health departments for updates. Background A novel strain of Influenza A (formerly called SWINE FLU) was identified as the cause of human illness in Mexico and the United States in April of 2009. By May 6 there were approximately 2000 cases world-wide and 642 cases in the U.S. The 2009 outbreak of H1N1 has been declared pandemic which is defined as sustained community-level outbreaks of a new flu virus in two or more regions of the world. Flu epidemics exclude seasonal flu; H1N1 differs from seasonal flu because of the severity of symptoms and occurrence of complications. By the end of July 2009, 43,677 laboratory confirmed cases of H1N1 were reported in the U.S. On Oct 28 the CDC (2009a) announced that this was a substantial underestimate and the true number of cases was closer to 1.8 to 5.7 million based on a study by Reed et al (2009). NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 1 © National Certification Corporation (NCC) 2009 It is important to have accurate estimates of the true numbers of affected people to be able to provide and plan for needed services. For a complete review of history and epidemiology of H1N1 Influenza see Carlson et al, 2009, Wilkinson et al, 2006, & Labant & Greenawalt, 2009. Table 1 compares the seasonal influenza with Pandemic Influenza H1N1. Etiology Vaccine Symptoms Complications Seasonal Influenza A & B Have previously caused human illness Available Cough, fever, headache, malaise, myalgia, rhinitis, sore throat, GI symptoms Unusual in healthy adults Pandemic Influenza H1N1 Novel influenza virus – population lacks previous exposure Available Similar to seasonal flu; but may be more severe Increased risk for serious complications in previously healthy adults Impact on society Generally minimal May lead to alterations in patterns of daily life; business & school closures; possibility of quarantines, restricted travel & public gatherings to limit spread; disruption of basic services & access to supplies Based on (CDC, 2009b; DHHS, 2009; Labant & Greenwalt, 2009) Influenza viruses, RNA viruses, are classified into 3 groups or genera: A, B, and C. Influenza types A and B cause human illness, particularly seasonal flu. The dominant strains of each virus are included in yearly flu vaccines. Type C influenza virus produces mild symptoms in humans or no illness at all (CDC, 2007). Influenza Type A is further divided into subclasses based on the presence of 2 antigenically distinct surface proteins; hemagglutinin (H) and neuraminidase (N), which are key virulence factors (Wilkinson, Buttery, & Andersen, 2006). Since there are 16 discrete hemagglutinin and 9 neuraminidase subtypes many different arrangements of these surface proteins are possible. Thus there are different types of Influenza A. H1N1 denotes the subtype NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 2 © National Certification Corporation (NCC) 2009 of influenza A characterized by hemagglutinin 1 and neuraminidase 1; while avian influenza, H5N1 (bird flu), contains hemagglutinin 5 and neuraminidase 1. Influenza viruses evolve continuously and mutation can occur suddenly or gradually. When a mutation is slight it is called an antigenic drift. Seasonal influenza vaccines are subject to yearly modification because of antigenic drift. A significant mutation is called antigenic shift. Antigenic shift is the result of mutations of nonhuman (swine, avian) viruses or the rearrangement of human and nonhuman viruses. These mutations or rearrangements create novel subtypes; influenza H1N1 is a genetic mixture of swine, bird, and human viruses. The ability of the human immune system to identify and destroy this virus is limited (Carlson, Thung, & Norwitz, 2009; Labant & Greenwalt, 2009). Groups considered at high risk for severe complications and mortality from Pandemic Influenza (H1N1) Severe illnesses among pregnant women and infants have been reported. The epidemiology and range of illnesses are, as yet, unknown and subject to investigation. However children younger than 2 years of age, pregnant women, and women up to two weeks postpartum are considered to be at high risk for severe illness, influenza-related complications, and death. Women who experience pregnancy loss should be included in this group (CDC, 2009c). Local Public Health authorities may provide additional information about other groups at high risk within their jurisdictions. Susceptibility in pregnant women The fact that the immune system is altered during pregnancy may cause increased severity of illness. Cardiovascular and respiratory changes accompany pregnancy (increased heart rate, stroke volume, oxygen consumption; decreased lung capacity) which may raise risk factors. NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 3 © National Certification Corporation (NCC) 2009 Pregnant women do not seem to be at increased risk of contracting influenza compared with the general population. However they do have increased risk of complications from any type of influenza, especially in the third trimester. Pregnant women have a higher rate of hospitalization (four-fold) and higher mortality rates. Jamieson and colleagues revealed that by October 1, 2009, there were 28 deaths from H1N1 among pregnant women, representing 13% of all H1N1 deaths. The women were reported to be fairly healthy prior to contracting influenza. Complications usually involve the respiratory system (pneumonia) or predispose to preterm labor or premature rupture of membranes. The majority of maternal deaths occurred in the 3rd trimester from complications of viral pneumonia and ARDS (2009). Testing for H1N1 and beginning antiviral medications are therefore recommended for pregnant women with influenzalike illnesses (ILI) (CDC, 2009c). Vulnerability of newborns Influenza is not a common illness among newborn infants presumably due to the reduced contact between neonates and ill adults and children. There are reports of spread of influenza A in neonatal units (Bauer, Elie, Spence, & Stern, 1973; Cunney, Bialachowski, Thornley, Smaill, & Pennie, 2000; Munoz, et al., 1999; Sagerera, et al., 2002). Risk factors for infection were identified as mechanical ventilation, multiple gestation, prematurity, and low birth weight (Cunney, et al., 2000). Clinical presentation of H1N1 in adults People with uncomplicated influenza may experience fever, chills, headache, cough, sore throat, and rhinorrhea, shortness of breath, myalgia, arthralgia, fatigue, abdominal pain, vomiting, or diarrhea. Some patients have respiratory symptoms without fever. Clinical presentation of H1N1 in newborns The spectrum of H1N1 illness in newborns is not yet fully known and is subject to investigation. However the clinical features of influenza in neonates mimic those of sepsis NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 4 © National Certification Corporation (NCC) 2009 (Wilkinson, et al., 2006): respiratory distress, hemodynamic instability, metabolic derangements, feeding intolerance, altered CNS status, and changes in behavior. Diagnostic tests for 2009 Pandemic H1N1 According to the CDC most patients with clinical illness consistent with uncomplicated influenza living in an area where influenza viruses are circulating do not require diagnostic testing for clinical management. However testing should be considered when the decision is made to treat with antiviral medications for influenza. Treatment should be initiated without waiting for test results (CDC, 2009d). There are several types of diagnostic tests available: 1. Rapid influenza diagnostic test (RIDT) 2. Direct immunofluorescence assay (DFA) 3. Nucleic amplification tests such as real-time reverse transcriptase polymerase chain reaction (rRT-PCR) 4. Viral cultures RIDT or DFA tests have high specificity but variable sensitivity. They are useful as rapid screening tools; results are available within 0.5 to 4 hours. A positive result indicates influenza virus but does not reveal the type of viral infection. Negative results do not rule out Pandemic H1N1. Nucleic amplification tests are the most sensitive and specific but results may not be available for several days. The current CDC recommendations specify that if identification of H1N1 is required, testing with rRT-PCR assay specific for 2009 H1N1 influenza or viral culture should be performed. Testing is performed on specimens from the upper respiratory tract and should be collected using swabs with synthetic tips (polyester or Dacron) on plastic or aluminum shafts (CDC, 2009d; Labant & Greenwalt, 2009). NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 5 © National Certification Corporation (NCC) 2009 Current CDC recommendations for management of Pandemic 2009 H1N1 Influenza in intrapartum and postpartum hospital settings (CDC, 2009h) The CDC provides guidance for prevention and management of novel H1N1 flu infection in inpatient and outpatients at higher risk for complications. Both passive (signage) and active screening (interview and assessment) and limited points of entry (one established triage area) are recommended. Facilities are advised to implement mechanisms to identify and isolate ill patients, visitors, and staff. The risk of contact with H1N1 influenza virus should be minimized for pregnant women and newborns. Healthy pregnant women and infants who have NOT been in close contact with persons with suspected, probable, or confirmed cases of H1N1 flu should be managed in the usual manner according to established infection control guidelines. This should include: hand hygiene, respiratory hygiene and cough etiquette, avoidance of close contact (3 – 6 feet distance), use of PPE (face masks for patients, fit-tested N95 respirators for staff (CDC, 2009i)), isolation precautions (standard, contact, droplet). Care of Suspected or Confirmed H1N1 Influenza Infected Mother and Newborn in Stable Condition in Labor & Delivery, Recovery, and Postpartum Settings. Labor/Antepartum (CDC, 2009h, 2009i) Single patient room, when possible or cohort Facemask for patient when outside room Staff use of fit-tested respirator within 6 feet of patient Standard precautions for all patient care Diagnostic testing and immediate empiric antiviral therapy with neuraminidase inhibitor; do not delay antiviral therapy pending diagnostic testing results Allow presence of healthy adults who are necessary for woman’s emotional well-being and care Educate patient and family of procedures for infection control for mother & newborn Encourage breastfeeding as an important method of protection for the infant (Lawrence & Bradley, 2009) Delivery/Intrapartum Setting NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 6 © National Certification Corporation (NCC) 2009 There are no reports of H1N1 influenza infection in the fetus transmitted via the placenta. However, the neonate may be exposed to infected respiratory secretions from a symptomatic mother through droplet transmission. The newborn is immunologically immature and, although maternal antibodies may have been acquired during the 3rd trimester, may still lack sufficient immunologic competence against H1N1. To protect the infant from exposure to respiratory secretions the following guidelines are recommended: Delivery/Intrapartum (CDC, 2009h) Mother wears a facemask throughout labor, as tolerated, and when outside room Single patient room, when possible or cohort Staff use of fit-tested respirator within 6 feet of patient, wear surgical mask with face shield, gloves, and gown during delivery Immediately place newborn on open warmer at least 6 feet away from the mother Stable neonates may remain in delivery area prior to transfer to newborn nursery Bathe the neonate as soon as temperature is stable Recovery/Postpartum Setting The CDC recommends a two-step process for management of postpartum women and their newborns. Step 1 is reviewed in this section; Step 2 is addressed below. Recovery/Postpartum (CDC, 2009h) Step 1: Consider temporary separation of mother and newborn until ALL of the following criteria have been met: The mother has received antiviral medication for at least 48 hours AND; She is fever-free for 24 hours without the use of antipyretics AND; She is able to control coughing and respiratory secretions When these criteria are met, close contact between mother & infant may begin. The most appropriate placement of mother and infant should be based on hospital configuration and current infection control practices. It is acceptable to place the infant in an incubator in the mother’s room. If incubators are not available, the neonate can be placed in an open bassinet at a distance of greater than 6 feet from the mother, “ideally separated by a Plexiglas barrier or curtain. Depending on staff/resources, the newborn may also be placed in NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 7 © National Certification Corporation (NCC) 2009 separate room, including the newborn nursery using standard precautions. Infant care should be provided by a healthy family or staff member” (CDC, 2009i, p. 5). Newborn Care/Infant Feeding Considerations (CDC, 2009h) Healthy term newborns of infected mothers with suspected or confirmed H1N1 influenza are considered EXPOSED, rather than infected, providing they are delivered in the inpatient setting when infection control guidelines have been followed. Although these infants should be monitored for signs of infection, they may be housed in the term nursery and cared for using standard precautions. If the infant is temporarily separated from his mother, feeding should be provided by a healthy caregiver until criteria are met for close contact. Step 2: The following guidelines are recommended when close contact is permissible to protect the newborn from droplet exposure. The baby should be brought to the mother’s room and she should avoid visiting the newborn nursery. Immediately before feeding and/or caring for her newborn, the mother should: Wash hands with soap and water Put on a face mask Observe respiratory hygiene/cough etiquette These precautions should be continue for 7 days after symptom onset or 24 hours after resolution of symptoms whichever is longest If the infant develops symptoms of influenza, he/she should be tested for influenza virus infection (CDC, 2009e). Antiviral Treatment & Chemoprophylaxis for Infants Younger than 1 Year of Age Current CDC Recommendations Include (CDC, 2009g) Oseltamivir (TamiFlu) has been authorized by the FDA for emergency use in infants younger than 1 year of age. Age Recommended Treatment Dose Recommended Prophylaxis Dose (5 days) twice daily (10 days) once daily Under 3 12 mg Not recommended; limited data on months use in this age group 3–5 20 mg 20 mg months 6 – 11 25 mg 25 mg months NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 8 © National Certification Corporation (NCC) 2009 Antiviral Treatment for Pregnant Women and New Mothers Current CDC Recommendations Include (CDC, 2009g) Empiric antiviral treatment initiated as soon as possible after the onset of influenza symptoms, ideally within 48 hours, regardless of gestational age. Treat for 5 days with oseltamivir (TamiFlu) 75 mg capsule twice per day or zanamivir (Relenza) 10 mg (two 5-mg inhalations) twice per day. Both drugs are in Category C. Oseltamivir may be preferred due to higher systemic absorption, may suppress viral loads more effectively Lower serum concentrations achieved with zanamivir; may be preferred when concern exists over potential in-utero fetal exposure (e.g. 1st trimester) Do not delay antiviral treatment pending results of laboratory testing A negative rRT for influenza does not rule out H1N1 Post-Exposure Antiviral Chemoprophylaxis for Pregnant Women and New Mothers Current CDC Recommendations Include (CDC, 2009g) Do not wait for test results to begin prophylaxis Consider 10 day course of oseltamivir (TamiFlu) 75 mg capsule once per day or zanamivir (Relenza) 10 mg (two 5-mg inhalations) once per day. Zanamivir may be preferred because of lower systemic concentrations, NOT recommended for women with asthma or underlying respiratory disorder Risk of H1N1 influenza is lowered with chemoprophylaxis but not eliminated. Immunity from infection is not conferred, protection ceases when medication is discontinued Visitation, Hospital Discharge, and Home Considerations Maternity and neonatal services are strongly urged to restrict visiting for all areas during influenza season (ambulatory, inpatient, birthing units, nurseries and NICUs). Limit hospital visitors to healthy persons who are necessary for patient’s care and emotional well-being. Educate mother, family and other caretakers on techniques to prevent transmission of H1N1 influenza virus and how to recognize signs of illness in the newborn after discharge. Assure timely postpartum and newborn follow-up visits. Encourage breastfeeding and refer mother for lactation consultation as needed. All persons in the home with suspected or confirmed H1N1influenza infection should avoid close contact with the newborn until they have been free of fever for 24 hours without NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 9 © National Certification Corporation (NCC) 2009 medication or until 7 days after symptom onset, whichever is longer. If avoidance is not possible, contacts should perform careful hand hygiene, environmental hygiene, respiratory hygiene, and cough etiquette. All persons who live with or provide care for infants younger than 6 months of age should be vaccinated against H1N1 influenza as well as seasonal influenza. H1N1 Exposed Preterm Neonates All exposed preterm neonates should be closely monitored, placed in incubators, isolated or cohorted. Caretakers are advised to wear eye shields and fit-tested N95 respirators. Contact and droplet precautions should be enforced and antiviral treatment considered. Recommendations for Breastfeeding (Lawrence & Bradley, 2009) Breastfeeding should be encouraged as human milk conveys immune protection to neonates. H1N1 influenza virus does not pass through human milk however the close contact between mother and newborn can facilitate transmission of the virus. Breastfeeding and H1N1 Careful hand washing prior to any contact Wash breast with soap and water; rinse well Mother should wear a surgical mask to prevent inoculation of newborn Use clean blankets and burp cloths for each contact Monitor compliance while on inpatient units Antiviral medication is not a contraindication If the mother is too ill to directly nurse the infant she can express milk; wear mask and gloves while collecting milk Containers with expressed human milk should be wiped down and stored separately Healthy persons should feed EHM to the infant until the mother improves H1N1 Influenza Vaccine and Seasonal Influenza Vaccine (CDC, 2009j) There are separate vaccines available for H1N1 Influenza and seasonal flu; both are recommended for pregnant and breastfeeding women and women up to 2 weeks postpartum. Since infants younger than 6 months of age are ineligible for the vaccine, everyone who lives NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 10 © National Certification Corporation (NCC) 2009 with or cares for an infant less than 6 months of age should also receive the vaccine. H1N1 monovalent flu vaccine has not shown to cause harm to pregnant women or their babies. Adjuvants are substances added to vaccines to increase their effectiveness. There are no adjuvants in either the H1N1 influenza vaccine or the seasonal influenza vaccine. Multi dose vials of flu vaccine contain the preservative thimerosal to prevent bacterial growth. Since there are concerns regarding exposure to thimerosal during pregnancy, preservative free vaccine has been manufactured. The 2009 H1N1 influenza vaccine in a single dose syringe is preservative free. There is no evidence that thimerosal is harmful to pregnant women or fetuses; the CDC recommends pregnant women receive the vaccine either with or without preservative. There is a nasal spray vaccine available for both H1N1 influenza and seasonal flu. Nasal sprays contain live attenuated viruses and are NOT licensed for use in pregnant women. After delivery women can receive the nasal spray even if they are breastfeeding. Inactivated seasonal flu vaccine and H1N1 monovalent vaccine may be administered on the same day, but given at different sites. Co-administration of two live vaccines on the same day is not recommended; they should be separated by at least 4 weeks. Pregnant women are not known to have an increased risk of side effects from vaccines. Clinically significant adverse effects following vaccination should be reported to the Vaccine Adverse Event Reporting System (http://vaers.hhs.gov/) NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 11 © National Certification Corporation (NCC) 2009 References Bauer, C. R., Elie, K., Spence, L., & Stern, I. (1973). Hong Kong influenza in a neonatal unit. JAMA, 223(11), 1233 - 1235. Carlson, A., Thung, S. F., & Norwitz, E. R. (2009). H1N1 influenza in pregnancy: What all obstetric care providers ought to know. Reviews in Obstetrics and Gynecology, 2(3), 139 - 145. CDC (2007, December 20, 2007). Types of influenza viruses Retrieved Nov 10, 2009, from http://www.cdc.gov.flu/about/viruses/types.htm CDC (2009a, October 28, 2009). Questions and answers: EID article "Estimates of the prevalence of pandemic (H1N1) 2009, United States, April-July 2009" Retrieved November 5, 2009, from http://www.cdc.gov/h1n1flu/eid_qa.htm CDC (2009b). Clinical signs & symptoms of influenza Retrieved November 5, 2009, from http//:www.cdc.gov/flu/professionals/acip/clinical/htm CDC (2009c, October 16, 2009). Updated interim recommendations for the use of antiviral medications in the treatment and prevention of influenza for the 2009-2010 season Retrieved November 8, 2009, from http://www.cdc.gov/h1n1flu/recommendations.htm CDC (2009d, September 29, 2009). Interim recommendations for clinical use of influenza diagnostic tests during the 2009-10 influenza season Retrieved November 8, 2009, from http://www.cdc.gov/h1n1flu/guidance/diagnostic_tests.htm CDC (2009e). Interim guidelines on specimen collection, processing, and testing for patients with suspected novel influenza A (H1N1) virus infection Retrieved November 8, 2009, 2009, from http://www.cdc.gov/h1n1flu/specimencollection.htm CDC (2009g, October 16, 2009). Recommendations for use of antiviral medications for the management of influenza in children and adolescent for the 2009-2010 season-Pediatric supplement for health care providers Retrieved November 8, 2009, from http://www.cdc.gov/h1n1flu/recommendations_pediatric_supplement.htm CDC (2009h, November 11, 2009). Interim guidance: Considerations regarding 2009 H1N1 influenza in intrapartum and postpartum hospital settings Retrieved november 20, 2009, from http://www.cdc.gov.h1n1flu/guidance/obstetric.htm CDC (2009i, September 24, 2009). Interim recommendations for facemask and respirator use to reduce 2009 influenza A (h1n1) virus transmission Retrieved November 21, 2009, from http://www.cdc.gov/h1n1flu/masks.htm CDC (2009j, November 2, 2009). 2009 influenza vaccine and pregnant women: Information for health care providers Retrieved November 21, 2009, from http://www.cdc.gov/h1n1flu/vaciicination/providers_qua.htm Cunney, R. J., Bialachowski, A., Thornley, D., Smaill, F. M., & Pennie, R. A. (2000). An outbreak of influenza A in a neonatal internsive care unit. Infect Control Hosp Epidemiol, 21(7), 449 - 454. DHHS, U. S. (2009). Retrieved November 5, 2009, from http://www.hhs.gov/news/press Jamieson, D. J., Honein, M. A., Rasmussen, S. A., & al, e. (2009). Novel influenza A (H1N1) pregnancy working group. H1N1 2009 influenza virus infection during pregnancy in the USA. Lancet, 374, 451 - 458. Labant, A., & Greenwalt, J. A. (2009). Pandemic flu. A major concern for pregnant women. Nursing for Women's Health, 13(5), 374 - 382. Retrieved from http://nwh.awhonn.org Lawrence, R. A., & Bradley, J. S. (2009). Breastfeeding advice for mothers with possible H1N1 infaction. AAP News, 30(11), 11. Munoz, F. M., Campbell, J. R., Atmar, R. I., Garcia-Prats, J., Baxter, B. D., Johnson, L. E., et al. (1999). Influenza A outbreak in a neonatal intensive care unit. Pediatr Infect Dis J, 18(9), 811 - 815. NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 12 © National Certification Corporation (NCC) 2009 Reed, C., Angulo, F.J., Swerdlow, D.L., Lipsitch, M., Meltzer, M.I., Jernigan, D., Finelli, L. (2009). Estimates of the prevalence of pandemic (H1N1) 2009, United States, April-July 2009. Emerg Infect Dis. doi:10.3201/eid1512.091413 Sagerera, X., Ginovart, G., Raspall, F., Rabella, N., Sala, P., Sierra, M., et al. (2002). Outbreaks of influenza A virus in neonatal intensive care units. Pediatr Infect Dis J, 21(3), 196 200. Wilkinson, D. J., Buttery, J. P., & Andersen, C. C. (2006). Influenza in the neonatal intensive care unit. Journal of Perinatology, 26, 772 - 776 Author Terri A. Cavaliere, DNP (c), NNP-BC NNP, Neonatal Intensive Care Unit North Shore University Hospital Clinical Assistant Professor North Shore University Hospital, Manhasset, NY School of Nursing State University of New York, Stony Brook, NY Clinical Preceptor Neonatal Nurse Practitioner Program Columbia University, New York, NY Copies of this document can made for personal use without charge. For commercial purposes, contact Betty Burns, NCC Executive Director, [email protected] NCC Update of H1N1 Influenza -12/2009 NCC 142 E. Ontario #1700, Chicago, IL 60611 www.nccwebsite.org 13