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FluSurv-NET Influenza Hospitalization Surveillance Project 2011-12 Case Report Form Instructions TABLE OF CONTENTS FluSurv-NET Case Definition ......................................................................................................................... 2 Community Associated vs. Healthcare Facility-associated Cases ................................................................. 2 Sources of Information for Completing the Case Report Form (CRF)........................................................... 2 Minimum Dataset for Timely Reporting (“The Minimum Five”) .................................................................. 4 Data Transmission ......................................................................................................................................... 4 Unique Case Identifier (Case ID) ................................................................................................................... 4 A. Patient Data (This information is not sent to CDC).................................................................................. 5 B. Reporter Information ................................................................................................................................ 7 C. Enrollment Information ............................................................................................................................ 8 D. Influenza Testing Results ........................................................................................................................ 13 E. Admission and Patient History ................................................................................................................ 15 F. Tests, Procedures and Interventions During Hospital Stay .................................................................... 18 G. Bacterial Pathogens ............................................................................................................................... 19 H. Viral Pathogens ....................................................................................................................................... 22 I. Influenza Treatment................................................................................................................................. 23 J. Chest Radiograph During Hospital Stay ................................................................................................... 24 K. Discharge Summary ................................................................................................................................ 25 L. ICD-9 Discharge Diagnoses ...................................................................................................................... 27 M. Vaccination History ................................................................................................................................ 28 Appendix 1. Nosocomial Case classification Schematic.............................................................................. 32 Appendix 2. Guidance on Classifying Underlying Medical Conditions ....................................................... 33 Appendix 3. Definition of Sterile and Respiratory Sites .............................................................................. 39 Appendix 4. Guide for Determining When to Report Various Pathogens ................................................. 40 Appendix 5. Instructions And Documents for Vaccination History............................................................ 41 1 FLUSURV-NET CASE DEFINITION A FluSurv-NET case patient is defined as a person who is/has: A resident of the catchment area Admitted to a catchment area hospital during an influenza season, which typically lasts from October 1, 2011 to April 30, 2012 o For patients with healthcare-facility associated infections, please note the following: Their admission date must be on or after October 1, 2011 (cases with a positive influenza test date on or after October 1 who were hospitalized before then should not be included) Please continuing monitoring through May 31 for any potential healthcare-facility associated influenza infections among patients admitted on or before April 30, 2012 Admitted to hospital no more than 14 days after a positive influenza test Evidence of a positive influenza test by at least one of the following methods: o Viral culture o Immunofluorescence antibody staining (direct [DFA] or indirect [IFA]) o Reverse transcriptase polymerase chain reaction (RT-PCR) o A commercially available rapid diagnostic test for influenza o Serologic testing o OR a positive, unspecified influenza test noted in the medical chart (e.g., a written note in the admission H&P or discharge summary) Exclusion Criteria Resident of a county outside of the catchment area Admitted to a catchment area hospital before October 1, 2011 or after April 30, 2012 (Please note: surveillance for healthcare-facility associated cases will continue through May 31, but the patient should have been admitted on or before April 30, 2012) No positive influenza tests and no note indicating a positive test in medical chart Initial hospital admission more than 14 days after positive influenza test COMMUNITY ASSOCIATED VS. HEALTHCARE FACILITY-ASSOCIATED CASES Both community-associated and healthcare facility-associated (nosocomial) cases will be collected during the 2011-12 influenza season This classification will be made at CDC using the following data elements: o Date of admission o Date of first positive flu test o Reason for admission o Onset of respiratory symptoms The schematic in Appendix 1 depicts the classification process SOURCES OF INFORMATION FOR COMPLETING THE CASE REPORT FORM (CRF) At a minimum, the following sources of information should be used to complete the case report form. The types of information generally found in each source are listed below. o Admission history and physical (Admission H&P) or past medical history (PMH) Influenza testing results 2 o o o o o o o Underlying medical conditions Reason for admission Acute illness and symptom onset dates Antiviral treatment during previous hospitalization Pregnancy status at admission Discharge summary Influenza testing results Chest x-ray dates and results Mechanical ventilation and/or ECMO Antiviral treatment ICD-9 codes ICU admission and discharge Discharge diagnoses Pregnancy status at admission and discharge Patient outcome Face Sheet Reason for admission Underlying medical conditions or prior illnesses Discharge ICD-9 codes Radiology section of the medical chart Chest x-ray dates and results Laboratory section of the medical chart Influenza test results Invasive bacterial infections Viral pathogen infections Intensive care unit (ICU) notes (if patient admitted to an ICU) Underlying medical conditions or prior illnesses ICU admission and discharge dates Mechanical ventilation and/or ECMO Medicine lists (Med list) Underlying medical conditions or prior illnesses Antiviral treatment Laboratory line lists Influenza test results Invasive bacterial infections Viral pathogen infections 3 MINIMUM DATASET FOR TIMELY REPORTING (“THE MINIMUM FIVE”) Please complete the following five data elements as soon as possible: o Unique Case ID o Hospital admission date o Sex o Date of birth or age o Evidence of positive flu test These data elements are necessary for calculating age-specific hospitalization rates, and are therefore critical for monitoring the severity of the season and/or identifying any unusual shifts in affected age groups affected. The timeliness of data reporting for each site is based on the submission of these minimum variables DATA TRANSMISSION Data are to be submitted to CDC weekly by close-of-business each Tuesday CDC will send an email to remind all sites to post their data to the secure FTP site UNIQUE CASE IDENTIFIER (CASE ID) Field located at the top right hand corner of each page of the case report form Assign a unique identifier to each case as soon as possible The 11-digit identifier consists of the following components: o Your two letter state abbreviation o 4 digit description of the influenza season (e.g., 1112) o Letter designation for case type: ‘A’ for adult cases 'F’ for pediatric cases o 4 digit unique case number (e.g., 0001). The complete case ID will look something like CO1112A0001 or TN1112F0001. With each new influenza season, you can begin again with 0001 as the last 4 digits of the case ID. The season designation changes yearly so there should not be any duplicate case ID’s. Should a case be deleted, DO NOT reuse the Case ID Case ID should be recorded in the case report database as soon as possible 4 A. PATIENT DATA (THIS INFORMATION IS NOT SENT TO CDC) Last Name Enter patient’s last name First Name Enter patient’s first name Phone Number 1 First phone number for patient, including area code The text of this field can be modified in the Word version of the case report form if your site plans to use this field for a specific phone number (i.e., home phone) Phone Number 2 Second phone number for patient, including area code The text of this field can be modified in the Word version of the case report form if your site plans to use this field for a specific phone number (i.e., mobile phone) Emergency Contact 1 Name and/or contact information for patient’s first emergency contact Emergency Contact 2 Name and/or contact information for patient’s second emergency contact Street Address Patient’s home address (including street address, city, zip) If patient is homeless, enter “homeless” If patient is a resident of a long-term care facility (LTCF) or other chronic care facility enter the facility street address City Zip Patient’s city of residency If patient is homeless, leave blank If patient is a resident of a long-term care facility (LTCF) or other chronic care facility enter the facility city Patient’s zip code of residency If patient is homeless, leave blank If patient is a resident of a long-term care facility (LTCF) or other chronic care facility enter the facility’s zip code Chart Number Patient’s medical chart number 5 Primary Provider Name Primary provider’s last name, first name and middle initial Provider Phone Number Primary provider’s phone number, including area code Provider Fax Number Primary provider’s fax number, including area code Site Use 1 Text field for site use The name of this field can be modified in the Word version of the case report form if your site plans to use this field for a specific purpose Site Use 2 Text field for site use The name of this field can be modified in the Word version of the case report form if your site plans to use this field for a specific purpose Site Use 3 Text field for site use The name of this field can be modified in the Word version of the case report form if your site plans to use this field for a specific purpose Site use 4 Text field for site use The name of this field can be modified in the Word version of the case report form if your site plans to use this field for a specific purpose 6 B. REPORTER INFORMATION 1. Reporter Name The name of the person reporting the case (e.g. infection control practitioner, laboratory contact) or Surveillance Officer (SO) completing the form Use format: last name, first name, middle initial This information is not required and the field can be adapted to your site’s specific needs Please note this information is transmitted to CDC 2. Date Reported Enter date reported in MM/DD/YYYY format Date the case was reported to the EIP site or Surveillance Officer 7 C. ENROLLMENT INFORMATION 1. Case Classification Indicate whether the case was identified through normal prospective influenza hospitalization surveillance or through a case ascertainment audit (e.g., discharge audit, laboratory audit, death audit) 2. State Two letter postal code of patient’s state of residence 3. County Patient's county of residence The case definition limits cases to counties of residence in your catchment area for this project. Do not include cases that reside outside the catchment area. List only county name here Other related information such as city of residence can be listed above in the patient address field College students are included in the population of the county of their dormitory/college residence 4. Case Type Indicate age category of patient at time of hospitalization: o Pediatric < 18 years o Adult: ≥ 18 years 5. Date of Birth Patient’s date of birth Enter date of birth in MM/DD/YYYY format 6. Age Patient’s age on date of admission; include units of age o If patient’s age is < 1 month, indicate age in days o If patient’s age is 1 to 11 months, indicate age in months o If patient is 12 months or older, indicate age in years Examples: o 1 week of age should be entered as 7 days o 6 weeks should be entered as 1 month o 40 days of age should be entered as 1 month o 23 months of age should be entered as 1 year 7. Sex Indicate the genetic sex of the case 8. Race Race of patient as noted in the medical chart or reported by a physician or ICP 8 Only one box can be checked If multiple races indicated, select ‘multiracial’ The minimum categories for the Federal statistics of race data are defined as follows: o American Indian or Alaska Native: A person having origins in any of the original peoples of North and South America (including Central America) and who maintain tribal affiliation or community attachment. o Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent. Can include the following: Cambodia, China, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. o Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” are sometimes used in addition to “Black” or “African American”. o Native Hawaiian or other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. o White: A person having origins in any of the original peoples of Europe, the Middle East, or North Asia. Some institutions combine race and ethnic coding. For example, they might define a person’s race as “Hispanic”. This case would have a race coded as “Not Specified” and ethnicity coded as “Hispanic”. If the patient or proxy is interviewed to obtain vaccination history and race is unknown after medical chart review, the interview may be an opportunity to collect the patient’s race If race is unknown after exhausting all possible sources for this information, please check “Not specified” If “other” listed, please check “Not specified” 9. Ethnicity Ethnicity of patient as noted in the medical chart or reported by a physician or ICP Provide ethnicity EVEN IF race is already indicated but do not make assumptions based on patient’s name Hispanic or Latino ethnicity indicates a person of Cuban, Mexican, Puerto Rican, South or Central American, or some other Hispanic origin, regardless of race. For example, many Whites individuals are also Hispanic or Latino. Some institutions combine race and ethnic coding. For example, they might define a person’s race as “Hispanic.” This case would have a race coded as “Not Specified” and ethnicity coded as “Hispanic”. If the patient or proxy is interviewed to obtain vaccination history and ethnicity is unknown after medical chart review, the interview may be an opportunity to collect the patient’s ethnicity If ethnicity is unknown after exhausting all possible sources for this information, please check “Not Specified” 10. Hospital ID Where Patient Treated Hospital where patient received treatment for influenza infection Use the ABCs Hospital ID codes you that use for standard surveillance, if applicable 9 If a new hospital ID is needed, please contact CDC 10a. Admission date Date of admission to the hospital where patient was treated Enter the admission date in MM/DD/YYYY format Hospital admission is often defined as an overnight stay in a hospital. However, patients who are admitted for hospitalization and discharged the same day are also considered to have been hospitalized as long as their visit involved an admission, not just an ER or outpatient visit. If a patient admitted to the hospital dies before completing an overnight stay, that patient should also be included in the surveillance. Emergency room visits and outpatient visits are not hospitalizations unless the patient is admitted following the emergency room or outpatient visit If the patient is admitted through the emergency department into an acute care hospital, the date of admission should be the date the patient was admitted to the ward, not the date first seen in the emergency department. NEW FOR 2011-12: If patient is admitted for observation and stayed for 24 hours or more, then this should be considered a hospitalization Date of admission should be recorded in the case report database as soon as possible 10b. Discharge date Date of discharge from hospital where patient was treated or date of death if patient died Enter discharge date in MM/DD/YYYY format If the patient was discharged into a long term rehabilitation unit, hospice, or other longterm care facility please use the date of transfer to the rehabilitation facility as the date of discharge 11. Was patient transferred from another hospital? Indicate if patient was transferred from another acute care hospital before receiving treatment at the hospital where the chart is being reviewed Please note: If the patient was previously hospitalized and discharged, it is not considered a transfer. However, please try to review the medical record from that hospitalization for information that may be useful in completing the case report form 11a. Transfer hospital ID Hospital ID from where patient was transferred. Use the ABCs Hospital ID codes you use for standard surveillance. 11b. Transfer hospital admission date Record the date of admission to the hospital from which the patient was transferred Enter admission date in MM/DD/YYYY format 11c. Transfer date Record the date of the transfer to the hospital where the chart is being reviewed Enter transfer date in MM/DD/YYYY format 10 Please note that when a transfer date and admission date are provided, all CDC analyses will be based on the earlier of the two dates 12. Was patient a resident of an institutional setting or other chronic care facility prior to hospitalization? Indicate if the patient was in an institutional setting or other long-term care facility and admitted from there to a hospital for treatment of their influenza positive illness. 12a. Indicate type of facility (**new question for 2011-12 season**) This is a new question for 2011-12 season Indicate the type of institutional setting or long-term care facility. Examples include: o Nursing homes o Prison o Hospice o Group home o Assisting living facility o Rehabilitation hospitals o Board and Care o Other long-term care facilities 12b. Indicate name of facility List the name of the institutional setting or long-term care facility where patient was a resident. This information is NOT sent to CDC but may be helpful for sites intending to contact the facility to obtain vaccination history information 13. Does patient work in the healthcare industry? Indicate if the patient works in the health care industry Complete this question for ADULTS only Examples include, but are not limited to: o Ambulatory health services o Hospitals o Nursing/residential care facilities Healthcare professionals include all persons, paid and unpaid, working in healthcare settings who have the potential for exposure to patients and/or to infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces, or contaminated air Examples of healthcare industry jobs (these are only examples and do NOT constitute an exhaustive list of healthcare industry jobs): o Autopsy personnel o Contractual personnel o Dental personnel o Emergency medical service personnel o Home healthcare personnel o Laboratory personnel o Nurse 11 o o o o o o o o o o o o Nursing assistant Occupational therapist Pharmacist Physician Physician assistant Radiology technician Respiratory Therapist Speech therapist Students and trainees Technicians Therapist Ward clerk 13a. Does patient have direct patient contact? This question has been removed from the database, you do not need to answer it. 12 D. INFLUENZA TESTING RESULTS Provide influenza testing information (i.e., method, result, collection date, testing facility ID and specimen ID) for up to four tests This information will be used to better classify discordant influenza test results. Evidence of a positive flu test should be recorded in the case report database as soon as possible 1-4. Test Indicate the influenza testing method This information will most often be available in the laboratory section of the chart If testing was performed before hospital admission then notation of a positive test may only be in the admission H&P or the Discharge Summary If test type listed in the chart is EIA, check ‘Rapid’ as the test type For serologic tests, patient must have evidence of a 4-fold increase in the titer of paired IgG that were collected at least one month apart. o If these criteria are met, check “serology” as the test type and check the appropriate flu type (you no longer need to indicate patient’s titer) o Use the information from the first test to complete subquestions b, c and d. o If you are unable to determine whether the test showed IgM or IgG antibodies, if the test shows an elevated IgM titer, or if you only have a single IgG test then the person should not be considered a case If ‘IFA’ or ‘DFA’ is indicated, then select ‘Fluorescent Antibody’ as the test method If a positive result is recorded but the test type is not specified or if you cannot determine which test type was performed, check “Method Unknown/Note Only” 1a-4a. Result Indicate the result of the test entered above NEW FOR 2011-12: Include negative test results, if available Select only one option Choose the most specific result available o For example, if “Flu A H3” is indicated, check the ‘H3’ option o The “Flu A (not subtyped)” option should only be used when the subtype is unknown or not performed If virus type is not specified, check “Unknown” for the result o Only use “unknown” to indicate positive test results with unknown flu types o Do not use “unknown” to indicate a test was performed with an unknown result If a specific test method is not indicated, but a positive result is noted in either the admission H&P or Discharge Summary, then select ‘Method Unknown/Note Only’ o Please note, the case definition REQUIRES that the patient has laboratory-confirmed influenza. Mention of influenza without supporting documentation is insufficient. o To be considered a case, the chart must state a test for influenza was performed and the test was positive If a single test is Flu A&B positive and a Flu A subtype is indicated, please enter as two test/results: 13 o Both entries will have the same test method, specimen collection date, testing facility ID and Specimen ID o Indicate the Flu A subtype in the first result and check “Flu B” for the second result The “unsubtypable” option should only be checked if the isolate was sent for subtyping, but despite appropriate techniques (including correct probes and primers) the laboratory was not able to identify the isolate’s subtype o Isolates with an “unsubtypable” result should be sent to CDC for testing; please contact CDC to coordinate. If an isolate is subtyped, but the laboratory lacks the capabilities (e.g., correct primers and probers) to produce a subtype result, please check “Other” and specify “Cannot be subtyped” o The “Flu A (not subtyped)” result choice should not be selected; it should only be used for specimens that were not sent for subtyping o This designation allows us to distinguish between samples that were not sent for subtyping and samples that could not be successfully subtyped 1b-4b. Specimen collection date Do not leave this question blank Provide the date of specimen collection for the test entered above Enter specimen collection dates in MM/DD/YYYY format For serologic tests based on paired IgG, use the information from the first test to answer this question 1c-4c. Testing facility ID Use the ABCs hospital/lab ID codes (if applicable) to list the hospital or lab where the positive influenza diagnosis was made For patients who were tested in a physician’s office use the code “MDTST” for this field. o These patients may not have laboratory information in the chart, but positive test results will be noted in the admission H&P If testing was performed at the state lab, please use the code “XXPHL” where “XX” represents your state’s two-letter abbreviation If testing was done in a clinical laboratory but the name is unknown, use the code “UNKLB” Please contact the CDC Data Manager to develop a new code upon the first contact with a new hospital. For serologic tests based on paired IgG, use the information from the first test to answer this question 1d-4d. Specimen ID This information is optional If easily accessible, list the specimen ID for the specimen described above This information may be useful for linking laboratory and epidemiologic data for specific analyses For serologic tests based on paired IgG, use the information from the first test to answer this question 14 E. ADMISSION AND PATIENT HISTORY 1. Was patient discharged from any hospital within one week prior to the current admission date? Check ‘Yes’ if there is an indication that the patient was hospitalized one week or less before their current admission This information will be helpful in classifying community-acquired and healthcare facilityassociated infections 2. Reason for current admission Indicate the reason(s) for patient admission during the current hospitalization Check all that apply The following hierarchy of sources for admission information should be used 1. History and Physical (H&P) 2. Face sheet 3. Emergency Room notes **DO NOT use admission or discharge ICD-9 codes to complete this section** Use the following categories to classify reason for admission (check the category if any of these options below are listed in the chart) o Acute respiratory illness Bronchitis Cough Influenza Influenza-like disease (ILD or ILI) Upper respiratory infection (URI) Respiratory infection Viral syndrome Viral URI Fever and any of the symptoms listed above o Asthma and/or COPD exacerbation Asthmatic bronchitis Asthma exacerbation Chronic obstructive pulmonary disease (COPD) exacerbation Status asthmaticus o Pneumonia Bacterial pneumonia Bibasilar pneumonia Community-acquired pneumonia (CAP) Evaluate pneumonia Rule out pneumonia o Other respiratory or cardiac conditions Acute respiratory distress syndrome (ARDS) Chest pain Congestive heart failure (CHF) Cystic Fibrosis (CF) exacerbation Difficulty breathing (DB) 15 Dyspnea Hypoxia Idiopathic pulmonary fibrosis Respiratory distress Shortness of breath (SOB) Wheezing o Other (neither respiratory no cardiac conditions) If none of the above terms are listed o Unknown If no admission information is available Contact CDC if you have any questions 3. Date of onset of acute illness resulting in hospitalization List the date of the earliest event (e.g., illness, injury, symptoms) that resulted in the current hospitalization Enter onset date in MM/DD/YYYY format This information should be recorded in the Admission H&P Please note: It is possible for the dates of onset of acute illness resulting in hospitalization (Q3) and onset of respiratory symptom (Q4) to be the same 4. Date of onset of respiratory symptoms List the earliest date of onset of fever or cough related to this illness episode. Enter onset date in MM/DD/YYYY format This information should be recorded in the Admission H&P If specific respiratory symptoms are not indicated in the notes but onset of upper respiratory infection (URI) is recorded, use that date If no URI is recorded, use onset date of respiratory symptom(s) that led to this hospitalization episode. In some cases you will need to calculate the date of onset based on notes in the Admission H&P or Discharge Summary that indicate that fever or cough began days earlier. o For example if a patient is admitted 10/15 (Day 0) and the Admission H&P indicates the patient complained of fever/cough for three days, then the earliest date of onset of respiratory symptoms is 10/12: Date: Day Number: 10/12 -3 Onset 10/13 -2 10/14 -1 10/15 0 Admission Please note: It is possible for the dates of onset of acute illness resulting in hospitalization (Q3) and onset of respiratory symptom (Q4) to be the same 5. Body Mass Index (BMI) If BMI is available, provide this information even if height and weight are listed in the medical chart DO NOT calculate BMI from height and weight For adults ≥ 18 years of age and if BMI is provided: 16 o Indicate “Obese” in Question 8j, if BMI ≥ 30 o Indicate “Morbidly Obese” in Question 8j, if BMI ≥ 40 o If ‘obese’ or ‘morbidly obese’ is written in the chart do not attempt to estimate BMI, only mark the appropriate box in Question 8j 6. Height Indicate height and specify if units in centimeters (cm) or inches (in) 7. Weight Indicate weight and specify if units in kilograms (kg) or pounds (lbs) If multiple weights are noted in the medical chart, then use the weight recorded at admission If patient is pregnant, weight is not needed, but please ensure that pregnancy status is indicated in Question 8j 8. Did patient have any of the following pre-existing medical conditions? Do not leave this question blank If any of the conditions listed on the CRF are mentioned in the medical chart, check the specific condition and then ‘Yes’ for the appropriate condition category. If no mention is made, check ‘No/Unknown’ for each condition category. Pre-existing medical condition information may be found in the Admission H&P, Discharge Summary, and/or emergency department report Any listed condition should be considered a pre-existing condition unless it is obvious that the condition no longer exists OR if the condition is a new condition that was identified during the current illness If patient is pregnant, please provide the gestational age in weeks. If you need assistance calculating gestational age based on due date or expected date of confinement, contact CDC If an ICD-9 code for obese/morbidly obese is listed, please check the appropriate box in Q8j Please note the conditions listed are only examples and do NOT constitute an exhaustive list of underlying medical conditions; use the “Other, specify” option to indicate conditions that are not listed but qualify under each condition category Contact CDC if you have any questions regarding how to categorize a specified condition Examples of additional conditions to be included under each condition category are included in Appendix 2 NEW FOR 2011-12: Only record gestational age if patient is pregnant; if patient is post partum (two weeks or less) check the appropriate box. You do not need to indicate if patient is more than two weeks post partum. 17 F. TESTS, PROCEDURES AND INTERVENTIONS DURING HOSPITAL STAY 1. Did patient receive mechanical ventilation? This will most often be recorded in the Discharge Summary or, for patients admitted to the ICU, in the ICU notes. References to vent settings, oscillator, HFOV, or HI-FI are typically associated with mechanical ventilation. BiPAP and C-PAP alone are not indications of mechanical ventilation If there is no mention of mechanical ventilation, check ‘No’ 2. Did patient receive extracorporeal membrane oxygenation (ECMO or ‘on bypass’)? ECMO or ‘on bypass’ are often recorded in the Discharge Summary or ICU notes, if patient was admitted to ICU If not noted in the Discharge Summary or ICU notes, check ‘No’ 18 G. BACTERIAL PATHOGENS 1. Was there cultural confirmation of a bacterial infection within three days of admission? Answer ‘Yes’ if any sterile or respiratory site cultures obtained within 3 calendar days of hospital admission grew a bacterial pathogen Nasopharyngeal (NP) swabs should not be considered confirmation of a bacterial infection This information will frequently be in the Laboratory section of the chart. Examples to help determine if within three days of admission o Admission date was 1/12 and culture date was 1/15. In this case, we will assign Day 0 to the admission date (as it is the “reference” date for this question). Designate days as follows: Day 0=1/12 Day 1=1/13 Day 2=1/14 Day 3=1/15 Date: Day Number: 1/12 1/13 1/14 0 1 2 Admission Therefore, the culture date was within 3 days of admission date 1/15 3 Culture o Admission date was 3/25 and culture date was 3/21. Designate days as follows: Day 0=3/25 (Admit date) Day -1=3/24 Day -2=3/23 Day -3 = 3/22 We can stop here, this culture was not taken within 3 days of admission Date: 3/22 3/23 3/24 3/25 Day Number: -3 -2 -1 0 Culture Admission The following organisms, when grown from a sterile site, are NOT considered pathogens and should NOT be recorded: o Isolation of coagulase negative staphylococci o Isolation of Bacillus species, Corynebacterium species (diphtheroids), and other common contaminants unless speciated or isolated twice on blood or CSF cultures obtained within a 72 hour period from the same patient See Appendix 3 for definitions of sterile and respiratory sites See Appendix 4 for a guide to when to report various pathogens 2. If yes, specify Complete the following questions regarding the bacterial pathogen(s) identified 2a. Pathogen 1 Specify the pathogen identified Do not include contaminants 19 2b. Date of culture Specify the date of collection of the first positive culture Enter culture date in MM/DD/YYYY format 2c. If Staphylococcus aureus, specify methicillin resistance Specify methicillin resistance 2d. If Haemophilus influenzae, specify if type B Specify serotype designation based on the primary culture or other EIP laboratory report (e.g., reference laboratory or state laboratory) results 2e. If Neisseria meningitidis, specify serogroup Specify serogroup designation based on the primary culture or other EIP laboratory report (e.g., reference laboratory or state laboratory) results 2f. Site where pathogen identified Check all sterile or respiratory sites from which the pathogen was identified Sterile sites include: o Blood o Cerebrospinal fluid (CSF) o Brochoalveolar lavage (BAL) o Pleural fluid Respiratory sites include: o Sputum o Endotracheal aspirate o DO NOT include nasopharyngeal (NP) swabs If pathogen was isolated from an internal organ, specify exact location (e.g., lymph node, brain, heart, liver, spleen, vitreous fluid, kidney, pancreas, or ovary) in the “Other” field Note: “Tracheal” and “endotracheal” are the same 3. If multiple pathogens identified, specify: Complete the following questions regarding the second bacterial pathogen(s) identified within three days of admission If three or more bacterial pathogens identified, please contact CDC for instructions 3a. Pathogen 2 Specify the pathogen identified Do not include contaminants 3b. Date of culture Specify the date of the first positive culture Enter culture date in MM/DD/YYYY format Culture can be from a sterile or respiratory site 3c. If Staphylococcus aureus, specify methicillin resistance 20 3d. If Haemophilus influenzae, specify if type B Specify serogroup designation based on the primary culture or other EIP laboratory report (e.g., reference laboratory or state laboratory) results 3e. If Neisseria meningitidis, specify serogroup Specify serogroup designation based on the primary culture or other EIP laboratory report (e.g., reference laboratory or state laboratory) results 3f. Site where pathogen identified Check all sterile or respiratory sites from which the previously indicated pathogen was identified Sterile sites include: o Blood o Cerebrospinal fluid (CSF) o Brochoalveolar lavage (BAL) o Pleural fluid Respiratory/Non-sterile sites include: o Sputum o Endotracheal aspirate If pathogen was isolated from an internal organ, specify exact location (e.g., lymph node, brain, heart, liver, spleen, vitreous fluid, kidney, pancreas, or ovary) in the “Other” field Note: “Tracheal” and “endotracheal” are the same 21 H. VIRAL PATHOGENS 1. Was patient tested for any of the following viral pathogens within three days of admission? Indicate if the patient was tested, the test result and specimen collection date (if applicable) for any viral pathogen listed or indicate “other” and specify: o Respiratory syncytial virus/RSV o Adenovirus o Parainfluenza 1 o Parainfluenza 2 o Parainfluenza 3 o Human Metapneumovirus o Rhinovirus o Other, specify (specify pathogen in Q1h) If multiple test for a single pathogen were performed, please use the first positive test to answer these questions If patient test positive but results cannot distinguish between types of Parainfluenza, check “Other, specify” and specify “Paraflu, unspecified” Examples to help determine if within three days of admission o Admission date was 1/12 and specimen collection date was 1/15. In this case, we will assign Day 0 to the admission date (as it is the “reference” date for this question). Designate days as follows: Day 0=1/12 Day 1=1/13 Day 2=1/14 Day 3=1/15 Date: 1/12 1/13 1/14 1/15 Day Number: 0 1 2 3 Specimen Admission Collection Therefore, the specimen collection date was within 3 days of admission date o Admission date was 3/25 and specimen collection date was 3/21. Designate days as follows: Day 0=3/25 (Admit date) Day -1=3/24 Day -2=3/23 Day -3 = 3/22 We can stop here, this specimen was not taken within 3 days of admission: Date: 3/21 3/22 3/23 3/24 3/25 Day Number: -4 -3 -2 -1 0 Specimen Admission Collection 22 I. INFLUENZA TREATMENT 1. Did the patient receive treatment with an antiviral medication for influenza at any time during the course of this illness? This information will be in the discharge summary, the medication section of the chart, or, if the patient received antivirals prior to hospitalization, in the admission H&P 1a. If yes, indicate which antiviral medication(s) were used, or check unknown If the medication type is available, indicate the start date and the end date of the initial prescription as the first series. If any medication in the initial order ended and was then restarted at a later date, indicate the respective start date and end date of the second order of that drug as the second series. Enter treatment date(s) in MM/DD/YYYY format Treatment end date is the late date of treatment (either actual or calculated) Examples of multiple series and how to enter: o As a nursing home resident, patient A was a candidate for chemoprophylaxis and treated with Oseltamivir (Tamiflu) starting 10/1 and ending 10/5. Later that month, patient A was hospitalized with an influenza infection and treated with Oseltamivir (Tamiflu) and Rimantadine (Flumadine) starting 10/16 and ending 10/20 Series 1: Oseltamivir (Tamiflu) , start 10/1 and end 10/5 Series 2: Rimantadine (Flumadine), start 10/16 and end 10/20 Oseltamivir (Tamiflu), start 10/16 and end 10/20 o Patient B was hospitalized with an influenza infection and treated with Oseltamivir (Tamiflu) and Rimantadine (Flumadine) starting on 9/5. On 9/7, patient B was switched to Oseltamivir (Tamiflu) and Amantadine (Symmetrel) until 9/11 Series 1: Oseltamivir (Tamiflu), start 9/5 and end 9/7 Rimantadine (Flumadine), start 9/5 and end 9/7 Series 2: Amantadine (Symmetrel), start 9/7 and end 9/11 Oseltamivir (Tamiflu), start 9/7 and end 9/11 o Patient C was hospitalized with an influenza infection and treated with Oseltamivir (Tamiflu) starting 2/9. On 2/11, patient C was switched to Zanamivir (Relenza) until 2/15 Series 1: Oseltamivir (Tamiflu), start 2/9 and end 2/11 Series 2: Zanamivir (Relenza) , start 2/11 and end 2/15 Only indicate the dosages and frequencies for Zanamivir (Relenza), Oseltamivir (Tamiflu), or ‘other’ medications o QD = once a day o BID = twice a day o TID = three times a day If dosages of the same treatment change, enter as separate series If frequency and/or dosage information is unknown, enter “unknown” into the “Dose” field If date information is unknown, enter the date ‘11/11/1111’ 2. Additional treatment comments Include any treatment information that cannot be specified in the previous treatment table This is an open text field 23 J. CHEST RADIOGRAPH DURING HOSPITAL STAY 1. Was a chest x-ray taken within 3 days of admission? Refer to the Discharge Summary, Radiology section and/or Emergency Department notes to determine if a chest x-ray was performed with 3 days of admission. Example to help determine if chest x-ray taken within three days of admission o Admission date was 4/9 and chest x-ray was taken on 4/12. The admission date is Day 0 because it is the reference date for this question. Designate days as follows: Day 0: 4/9 Day 1: 4/10 Day 2: 4/11 Day 3: 4/12 Date: 4/9 4/10 4/11 4/12 Day Number: 0 1 2 3 Admission X-ray o Therefore, the chest x-ray date was within 3 days of admission date If patient was transferred or discharged recently from another hospital, please check x-rays taken from that initial hospitalization. The purpose of Section J is to assess communityacquired pneumonia, so it is important that the x-rays closest to the initial admission be checked If patient was in the Emergency Department prior to admission, then those x-rays should be checked 2. Were any of these chest x-rays abnormal? Indicate “No” if terms such as “normal x-ray” or “no acute disease” are provided If a chest CXR was performed (i.e. it is clearly indicated in the chart), however the interpretation is not available, please choose “Unknown” 2a. Date of first abnormal chest x-ray If multiple chest x-rays were performed within 3 days of admission, provide the date of the first abnormal chest x-ray Enter chest x-ray date in MM/DD/YYYY format For patients with pre-existing medical conditions, please record information for the first “newly abnormal” chest x-ray as they may have an abnormal baseline due to their medical condition 2b. For first abnormal chest x-ray, please check all that apply: Refer first to the radiology report and transcription (including the sections labeled ‘impression’, ‘final interpretation’, or ‘findings’) for impressions of the first abnormal x-ray. If the radiology report is not available, then record impressions from the radiologist’s or other clinician’s dictation of the transcription to complete this section. Check all of the boxes that are indicated Indicate “Multiple lobar infiltrate” for either unilateral or bilateral specification If ‘cavitation’ is indicated, check ‘Other, specify’ and indicate ‘cavitation’ 24 K. DISCHARGE SUMMARY 1. Was patient admitted to an intensive care unit (ICU)? Indicate if patient was admitted to the intensive care unit (ICU) during this hospitalization. Examples of specialty ICU units include (but are NOT limited to) the following: o Medical intensive care unit (MICU), o Surgical ICU (SICU) o Pediatric ICU (PICU) o Neonatal ICU (NICU) o Cardiac care unit (CCU) Do not include admission to a step-down unit or transitional care unit (TCU) This information will be in the Discharge Summary; however, if not mentioned in Discharge Summary, please check the chart to confirm there are no ‘ICU Notes’ 1a. Date of ICU admission Indicate the first date the patient was admitted to any ICU Enter ICU admission date in MM/DD/YYYY format 1b. Date of ICU discharge Indicate the date the patient was discharged from ICU (patient can be discharged to non-ICU ward or out of hospital) Enter ICU discharge date in MM/DD/YYYY format 2. Did the patient have any of the following diagnoses at discharge (check all that apply)? Review the Discharge Summary for indication of any of the following diagnoses: o Pneumonia o Guillan-Barré syndrome o Acute encephalopathy/encephalitis o Stroke (also referred to as a cardiovascular incident, CVI, cardiovascular accident, CVA) o Acute myocarditis o Acute respiratory distress syndrome (ARDS) Only check the condition if this is a new diagnosis related to the current hospitalizations (do not include pre-existing conditions) 3. What was the outcome of the patient? This information is typically n the last line of the discharge summary, but may also be found in the cover sheet or notes from the last day of hospitalization 3a. If discharged alive, please indicate to where: Select location to where patient was discharged from the following options: o Home o Other hospital (acute care) o Hospice o Long-term care facility (including nursing home, rehabilitation hospital, skilled nursing facility) 25 o Other, specify 4. If patient was pregnant on admission, indicate pregnancy status at discharge: Select pregnancy status at discharge from the following options: o Still pregnant o No longer pregnant o Unknown 4a. If patient was pregnant on admission but no longer pregnant at discharge, indicate pregnancy outcome at discharge: Select pregnancy status at discharge from the following options: o Miscarriage (or still birth) o Ill newborn (i.e., newborn needed to say in hospital and/or required ventilation after birth) o Newborn died o Healthy newborn (i.e., newborn promptly discharged home) o Abortion (surgical abortion or therapeutic abortion (TAB)) o Unknown This information will typically be in the H&P or Discharge Summary Please ensure that patient is female and that “Pregnant” is selected in Section E 5. Additional notes regarding discharge: Include any additional notes or diagnoses that may be of interest This is an optional field 26 L. ICD-9 DISCHARGE DIAGNOSES 1. List up to the first nine discharge ICD-9 codes List up to the first 9 ICD-9 discharge diagnoses codes List ICD-9 codes in the order they appear in the chart (i.e., the first listed ICD-9 code should be entered in the first blank) ICD-9 codes related to influenza and influenza-like illness (ILI) should only be entered if they are one of the first nine codes After billing is completed these are often available on the Face Sheet, but can also be found in the Discharge Summary Please include the decimal points Please include leading zeros If the patient has more than nine ICD-9 codes and one of them is related to obesity/morbid obesity, please report the first eight ICD-9 codes and list the obesity/morbid obesity ICD-9 code as the ninth ICD-9 code ICD-9 codes for obesity/morbid obesity include: ICD-9 Code V77.8 V85.3 V85.30V85.39 V85.4 V85.54 278 278.00 278.01 649.1 Description Obesity BMI between 30-39, adult BMIs between 30-39.9, adult BMI 40 and over, adult BMI, pediatric, ≥ 95th base on age Overweight, obesity, and other hyperalimentation Overweight and obesity Morbid obesity (also includes severe) Obesity complicating pregnancy, childbirth or pueriperium Obesity/ Morbid Obesity Obesity Obesity Obesity Morbid Obesity Obesity Obesity Obesity Morbid Obesity Obesity 27 M. VACCINATION HISTORY Refer to Appendix 5 for more detailed instructions regarding the provider fax and patient phone interviews 1. Did patient’s mother receive the influenza vaccine during fall or winter of the current influenza season? Complete this question only for mothers of patients who are less than six months of age This information may be notes in the Admission H&P Pharmacy lists may also contain patient vaccination history information Vaccination history sources should be queried in the following order: 1. Medical chart 2. State vaccination registry (if available) 3. Provider (fax or interview) 4. Patient /Proxy interview General statements in the Admissions H&P such as “immunizations up to date” should not be interpreted to mean influenza vaccine was given unless influenza vaccine is specifically mentioned Influenza vaccine may be given as early as August in North America Receipt of influenza vaccination after patient’s hospitalization also does not count, it must have been received at least 2 weeks prior to patient’s hospitalization Corresponds to Q1 (for children <6 months) in the phone survey 1a. If yes, specify mother’s vaccine type: Select vaccine type from the following types (or indicate “vaccine type unknown” if this information cannot be found): o Injected vaccine (Trivalent inactivated influenza vaccine (TIV)) o Examples of injected vaccine/TIV include, but are not limited to, the following: Fluzone Fluvirin Fluarix o Nasal spray (Live attenuated influenza vaccine (LAIV)) o Examples of nasal spray/LAIV include (but are NOT limited to) the following: FluMist This information may be found in the Admission H&P or the hospital computer systems Corresponds to Q1a (for children < 6 months) in phone survey 1b. If injected vaccine (TIV), specify type: This question has been removed from the database, you do not need to answer it 2. Did patient receive the influenza vaccine during fall or winter of the current influenza season This information may be found in the Admission H&P Pharmacy lists may also contain patient vaccination history information Vaccination history sources should be queried in the following order: 1. Medical chart 2. State vaccination registry (if available) 28 3. Provider fax or interview 4. Patient /Proxy interview General statements in the Admissions H&P such as “immunizations up to date” should not be interpreted to mean influenza vaccine was given unless influenza vaccine is specifically mentioned Influenza vaccine may be given as early as September in North America Receipt of influenza vaccination during or after hospitalization should not be entered Only after all sources of vaccination history have been exhausted and if no vaccination history can be obtained check “Unknown” Corresponds to Q1 (for children ≥6 months and adults) in phone survey 2a. If yes, specify dosage date information Enter dosage dates in MM/DD/YYYY format This information may be in the Admissions H&P, hospital computer system or state vaccination registry Vaccination history sources should be queried in the following order: 1. Medical chart 2. State vaccination registry (if available) 3. Provider (fax or interview) 4. Patient /Proxy interview Please note, some children need only one dose of vaccine. For these patients, leave the second dose date blank If patient received one or more doses of vaccine, but the dates are unknown, enter “11/11/1111” for the date of each dose received NEW FOR 2011-12: If the day of the month in which the vaccination was received is unknown, enter the last day of the month Corresponds to Q1a (for children ≥6 months and adults) in phone survey 2b. If yes, specify patient’s vaccine type: Select vaccine type from the following types (or indicate “vaccine type unknown” if this information cannot be found): o Injected vaccine (Trivalent inactivated influenza vaccine (TIV)) o Examples of injected vaccine/TIV include, but are not limited to, the following: Fluzone Fluvirin Fluarix o Nasal spray (Live attenuated influenza vaccine (LAIV)) o Examples of nasal spray/LAIV include (but are NOT limited to) the following: FluMist This information may be found in the Admission H&P or the hospital computer systems Corresponds to Q1b (for children ≥6 months and adults) in phone survey If vaccine type is not available in the medical chart or vaccination registry, please contact the provider for this information. However, you do not need to contact the patient/proxy 2c. If injected vaccine (TIV), specify type If the type of injected/TIV vaccine is known, please select from the following types: 29 o Regular intramuscular (IM) o High dose intramuscular (IM) o Intradermal If this information is unavailable, you do not need to contact the primary care provider or patient/proxy solely for the purposes of collecting the type of TIV Corresponds to Q1c (for adults) in phone survey 3. If patient < 9 years, did patient receive any seasonal influenza vaccine in previous years? Indicate whether the patient received a season influenza vaccine in ANY past season This information will rarely be documented in the chart so vaccination history sources should be queried in the following order: o State vaccination registry (if available) o Provider (fax or interview) o Patient /Proxy interview Corresponds to Q2 (for children ≥6 months) in the phone survey If this information is lacking (even if it is the only missing vaccination information), please try to contact the provider and/or patient/proxy 4. Did patient receive any type of pneumococcal vaccine at any age? This information will rarely be documented in the chart so vaccination history sources should be queried in the following order: o State vaccination registry (if available) o Provider (fax or interview) o Patient /Proxy interview Corresponds to Q2 (for children <6 months and adults) or Q3 (for children ≥6 months) in the phone survey If this is the only vaccination history unavailable for the patient, you do not need to query the patient/proxy or his/her provider 4a. If yes, please provide dosage date information: Enter date(s) that pneumococcal vaccine was administered o Include dates even if vaccine administered during hospitalization If patient received one or more doses of vaccine, but the dates are unknown, enter ‘11/11/1111’ for the date of each dose received NEW FOR 2011-12: If only the year in which vaccination the was received is known, enter the date as January 1 of that year NEW FOR 2011-12: If day of month in which vaccination was received is unknown, enter the first of the month as the date the vaccination was received Adult cases will have a maximum of two pneumococcal doses Pediatric cases will have a maximum of four pneumococcal doses Corresponds to Q2a (for children <6 months and adults) or Q3a (for children ≥6 months) in phone survey 4b. If patient ≥ 65 years, was vaccine received within last five years? This question does not need to be completed if the patient is less than 65 years of age 30 If this information is unavailable, you do not need to contact the primary care provider or patient /proxy solely for the purposes of determining the pneumococcal vaccine was received in last five years Corresponds to Q2b (for adults) in the phone survey 5. What is the source of vaccination history (check all that apply)? Identify all sources that were used to obtain vaccination history o A source should only be checked if information was obtained from it o Do not check sources that were unsuccessfully queried All reasonable means to obtain vaccination history should be used Vaccination history sources should be queried in the following order: o Medical chart o State vaccination registry (if available) o Provider (fax or interview) o Patient /Proxy interview If patient’s vaccination status is unknown, check “Patient Refused/Lost” If patient/proxy refuse or decline to provide vaccination information during the phone interview, check “Patient Refuse/Lost” 5a. If vaccination history obtained by phone interview, please specify source of interview: If applicable, specify the relationship of the proxy interviewee to the patient (e.g., spouse, other family member, caregiver, other or unknown).using the category code listed on the phone interview form If proxy, specify the relationship using the following codes: o 1 = Spouse o 2 = Family member o 3 = Caregiver o 4 = Other o 5 = Parent/Guardian o 99 = Unknown 31 FluSurv-NET Case Classification Schematic SCHEMATIC APPENDIX 1. NOSOCOMIAL CASE CLASSIFICATION NOT a Case NO Hospitalized patient AND Resident of catchment area AND Positive influenza test YES Positive influenza test within ≤ 14 days before hospital admission and < 3 days after admission NO NOT a Case Positive test was > 14 days before admission YES CA Case NO Positive test was > 3 days after admission Patient admitted for respiratory illness YES IND Case YES IND Case NO IND Case UNKNOWN O Respiratory symptom illness onset < 3 days after hospital admission NO HCFA Case Community-associated (CA) case: Respiratory illness onset or laboratory test occurs in the community or < 3 calendar days after admission to a healthcare facility. HCF-associated (HCFA) case: Respiratory illness onset or laboratory test occurs > 3 calendar days after admission to a healthcare facility. Indeterminate (IND) case: Does not fit one of the above criteria for exposure setting or a patient for whom the exposure setting cannot be determined due to lack of available data. 32 APPENDIX 2. GUIDANCE ON CLASSIFYING UNDERLYING MEDICAL CONDITIONS Any listed condition should be considered a prior or underlying condition unless it is obvious that the condition no longer exists or that it is a condition that occurred for the first time during the current illness. Please refer to the following lists for guidance in classifying conditions, but note this is NOT meant to be an exhaustive list. The sub-bullets below each condition are other common names or abbreviations for that condition. If you have any questions, contact a CDC EIP Flu data manager for assistance. 8a. Chronic lung disease Asthma/Reactive airway disease o Common abbreviations include: RAD Cystic fibrosis Emphysema/COPD Examples to include in “Other, specify” o Bronchopulmonary dysplasia (BPD) o Bronchiolitis obliterans o Chronic aspiration pneumonia o Chronic lung disease o Interstitial lung disease 8b. Cardiovascular disease Aatherosclerotic cardiovascular disease (ASCVD) o Arteriosclerotic heart disease Cerebral vascular incident/Stroke o Cerebrovascular accident (CVA) o History of stroke Congenital heart disease Coronary artery disease (CAD) o Coronary heart disease (CHD) Heart Failure/CHF o Congestive heart failure Examples to include in “Other, specify” o Aortic stenosis o Arrhythmias that have been medically treated (e.g., medication or pacemaker) o Atrial septal defect o Cardiomyopathy o Coarctation of the aorta o Current ischemic heart disease o Deep vein thrombosis o Endocardial cushion defect o Hypoplastic left ventricle syndrome o Mitral regurgitation o Pulmonary embolism 33 o Pulmonary hypertension o Pulmonary stenosis o Structural cardiac defects that may have been surgically or medically treated since childhood or presented later in life o Tetralogy of Fallot o Total anomalous pulmonary venous return o Transient ischemic attack (TIA) o Transposition of the great arteries o Triscupid atresia o Ventriculoseptal defect (VSD) 8c. Neurologic disorder Cerebral palsy Cognitive dysfunction Dementia o Alzheimer’s o Severe dementia o Multi-infarct dementia Development delay o Edward’s syndrome o Fragile X syndrome o Mentally handicapped o Mental retardation o Static encephalopathy o Trisomy 18 Down syndrome Plegias/Paralysis o Quadriplegia Seizure/Seizure disorder o Epilepsy o Febrile convulsions o Any seizure condition requiring routine anti-seizure medication Examples to include in “Other, specify” o Cornelia de Lange Syndrome o Kyphoscoliosis o Severe scoliosis o Spinal cord injuries o Spinal abnormalities o Other cognitive disabilities so severe that the handling of respiratory secretions is impaired or there is an increased risk of aspiration DO NOT include o Attention deficit disorder (ADD) o Attention deficit-hyperactive disorder (ADHD) o Language delay or disability o Learning disability o Speech delay or disability 34 8d. Neuromuscular disorder Duchenne muscular dystrophy Muscular dystrophy Multiple sclerosis Examples to include in “Other, specify” o Parkinson’s disease o Conditions that affect muscles of breathing or the ability to swallow (e.g., swallowing disorders/dysfunctions) o Myasthenia gravis 8e. Immunocompromised condition AIDS or CD4 count < 200 Bone marrow transplant o Also include peripheral stem cell transplants in this category o Hematopoietic stem cell transplant (HSCT) o Peripheral blood stem cell transplant (PBSCT) Cancer diagnosis in last 12 months o Includes recently diagnosed cancers o Non-Hodgkin’s disease o Leukemia) o Malignant tumors of any organ o DO NOT include melanoma skin cancer or non-melanoma skin cancers that have been removed Complement deficiency o C1 qrs deficiency o C3 deficiency o C2-C4 deficiency o C5-9 deficiency History of lymphoma or leukemia o Cured acute lymphocytic leukemia o Cured acute myelogenous leukemia o Cured lymphoma o Cured leukemia o Chronic lymphocytic leukemia o Common abbreviations include: CML, CLL, AML, ALL o Active lymphoma should be included in the ‘Hodgkin’s disease/lymphoma’ category o Active leukemia should be included in the ‘Cancer diagnosis in last 12 months’ category HIV Infection Hodgkins disease/lymphoma o Active lymphoma o Non-Hodgkin’s disease should be included in ‘Cancer diagnosis in last 12 months’ category Immunoglobulin deficiency o Agammaglobulinemia o IgM-, IgA-, or IgG-deficiencies 35 o Severe combined immunodeficiency (SCID) o Wiskott-Aldrich Syndrome Immunosuppressive therapy o Chemotherapy for cancer within 2 weeks of admission o Immunosuppressive therapy for cancer treatment or organ transplant o Transplant patients taking drugs to prevent rejection o Cyclosporine A o Tacrolimus (or FK-506 or Fujimycin) Multiple myeloma Organ transplant Steroid therapy o Oral or injected coriticosteroids taken within 2 weeks of admission o Dexamethasone o Methylprednisolone o Prednisone o Prescribe steroids Examples to include in “Other, specify” o Common variable immune deficiency (CVID) o Lupus o Systemic lupus erythematosis (SLE) 8f. Chronic metabolic disease Diabetes mellitus o Adult-onset diabetes o Type I or insulin-dependent o Type II or non-insulin dependent o Common abbreviations include: DM, ODM, IDDM, NIDDM Thyroid dysfunction o Graves disease (if patient receiving steroid therapy to control this illness, also check “steroid therapy” in the immunocompromised conditions section) o Hyperthyroidism o Hypothyroidism Examples to include in “Other, specify” o Addison’s disease o Adrenal insufficiency Cushing syndrome o Chronic pancreatitis o Congential adrenal hyperplasia o Diabetes insipidus o Endocrine disorders o Glycogen or other storage diseases o Hepatic dysfunction o Inborn errors of metabolism o Mitochondrial disorders o Pituitary abnormalities DO NOT include o Gestational diabetes 36 o Pre-diabetes o Steroid-induced diabetes o Osteoporosis 8g. Blood disorders/Hemoglobinopathies Sickle cell disease o Hemoglobin SS o Hemoglobin SC Splenectomy/Asplenia Examples to include in “Other, specify” o Alpha thalassemia o Beta thalassemia o Hemoglobin S-beta thalassemia DO NOT include o Sickle cell trait o Thalassemia trait o Thalassemia minor 8h. Renal disease Chronic kidney disease/chronic renal insufficiency o Renal damage o Renal dysfunction End stage renal disease/Dialysis o Renal failure (any cause) o DO NOT include acute renal failure (ARF) Glomerulonephritis Nephrotic syndrome Examples to include in “Other, specify” o Impaired creatinine clearance o Medullary cystic disease o Polycystic kidney disease o Renal tubular acidosis 8i. History of Guillain-Barré Syndrome GBS Acute inflammatory demyelinating polyneuropathy 8j. Other Alcohol abuse Current smoker Liver disease o Liver failure o Hepatitis B or C (ONLY if liver failure is indicated) Morbidly obese Mitochondrial disorder Obese 37 Pregnant o Please specify gestational age in weeks Post-partum (two weeks or less) o Woman delivered within 14 day of hospitalization 8k. Pediatric Conditions Abnormality of upper airway o Tracheostomy and other abnormalities of the mouth or throat that affect the ability to handle secretions o Patients without chronic lung disease receiving home oxygen or respiratory therapy are likely to have an abnormality of the upper airway o Patients receiving home oxygen or respiratory therapy due to a chronic lung disease should be recorded appropriately as having asthma, cystic fibrosis, and/or other chronic lung disease History of febrile seizures o History of seizures associated only with fever o Febrile convulsions o DO NOT list this condition for adults Long-term aspirin therapy o Includes children receiving daily aspirin therapy for 2 or more weeks Premature (gestational age <37 weeks at birth for patients <2 years) o Ex-preterm o Premature infant o Ex-preemie o If days and weeks are reported, specify exact gestational age at birth in weeks, DO NOT ROUND UP Do NOT include any of the following conditions: Acute renal failure Dyslipidemia Gestational diabetes Hypercholesterolemia Hyperlipidemia 38 APPENDIX 3. DEFINITION OF STERILE AND RESPIRATORY SITES A normally sterile site is blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, bone, joint fluid, or internal body site (lymph node, brain, heart, liver, spleen, vitreous fluid, kidney, pancreas, or ovary). Muscle should be considered a sterile site for group A Streptococcus (GAS) only. Pleural fluid: includes ”chest fluid”, thoracentesis fluid. Peritoneal fluid: includes abdominal fluid, ascites. Joint: includes synovial fluid; fluid, needle aspirate or culture of any specific joint (knee, ankle, elbow, hip, wrist). There is no need to enter the specific joint in the ”other” field. If you would like to indicate the specific joint, do so in the ”Comments” section. Bone: includes bone marrow Muscle: includes tissue or biopsy that is surgically obtained (considered an acceptable sterile site for GAS only) Internal Body Site: includes specimen obtained from surgery or aspirate from lymph node, brain, heart, liver, spleen, vitreous fluid, kidney, pancreas, or ovary. The following are respiratory sites: sputum and endotracheal aspirate. While these are nonsterile sites, they can indicate real bacterial infections with pathogens such as S. aureus and may be the only indication for a related pneumonia. Do not include nasopharyngeal (NP) swabs. The following are NOT sterile sites: skin infections such as skin abscesses, boils or furuncles, middle ear, amniotic fluid, placenta, sinus, wound, lung, gallbladder, appendix, cornea, or throat or subcutaneous tissue abscess. If an organism is isolated from one or more of these sites but NOT from one of the above listed sterile or respiratory sites, the patient is not considered to have a bacterial infection and “No” should be checked for the appropriate question on the form (Question 1 in Culture Confirmation of Bacterial Pathogens – Sterile or Respiratory Sites). Special circumstance: GAS and wound culture. If group A streptococcus is isolated from a wound culture and is accompanied by necrotizing fasciitis or streptococcal toxic shock syndrome (STSS) as defined by The Working Group on Severe Streptococcal Infections, it should be considered an invasive bacterial infection for this surveillance system. Antigen detection, counter immunoelectrophoresis, or other non-culture based methods will not be sufficient for reporting of bacterial infections in this surveillance system. Autopsy cases will be handled on a case-by-case basis. In some cases, autopsy specimens may be considered sterile sites. A CDC EIP Flu data manager should be contacted to discuss any autopsy case that is a potential case for surveillance. 39 APPENDIX 4. GUIDE FOR DETERMINING WHEN TO REPORT VARIOUS PATHOGENS If speciated (i.e., species has been identified) or isolated twice within a 72-hour period from the same patient (from two separate sets of blood cultures), the following organisms should always be considered pathogens: Bacillus Corynebacterium Gamella Micrococcus Prevotella Propionibacterium Staphylococcus aureus Stomatococcus Viridans streptococci The following organisms should never be reported as a pathogen: Staphylococcus auricularis Staphylococcus capitis Staphylococcus cohnii Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus saccharolyticus Staphylococcus saphrophyticus Staphylococcus simulans Staphylococcus warneri Staphylococcus xylosus 40 APPENDIX 5. INSTRUCTIONS AND DOCUMENTS FOR VACCINATION HISTORY Vaccination history information should be collected from the following sources (in order): 1) medical chart, 2) vaccination registry, 3) patient provider, and 4) patient/proxy interview Contacting Providers for Patient Vaccination Status The patient’s primary outpatient care provider only needs to be contacted if their influenza vaccination history is not noted in the medical record, state immunization registry or hospital database. If details about influenza vaccine are not available, contact the providers of case-patients to obtain vaccine history. If the medical chart does not contain the name of the patient’s primary care provider, it may be necessary to contact the patient or proxy to obtain that information. Attempt to contact a patient up at least three (3) times to obtain this information . If after these attempts the patient cannot be reached, the vaccination status questions should be marked as “UNKNOWN.” Do not record vaccination status as reported from the patient on the CRF or in the database if there is disagreement in vaccination history obtained from the patient and provider; only record vaccination status reported by the provider in that instance. If, after use of the medical chart, vaccination registry and provider record, the only available vaccination history is from the patient/proxy, then report the patient/proxy information. Study personnel will call the primary care physician’s office to confirm that the case patient is their patient. Study personnel will explain the purpose of the call and assure a confidential fax line. Study personnel will make at least three (3) phone calls and send at least three (3) faxes (pediatric and adult faxes are provided below) to the primary care providers’ office to try to obtain the information in the vaccine history section of the form. A physician, nurse, or other office staff may complete the form, and the information may be obtained over the phone or in person in lieu of sending a fax to the providers’ office. If case patient race/ethnicity information is missing or unknown after review of the medical chart and the provider is going to be contacted to obtain vaccination history, the provider fax form should be used as an opportunity to also collect race/ethnicity, if allowed by local authority. It is also an appropriate time to query information on height and weight if this information is missing. The physician vaccination faxes to be used for pediatric and adults are provided below: 41 Date: [current date] Dear Dr. [LastName]: The [State/Local Health Department], in collaboration with the Centers for Disease Control and Prevention, are tracking patients who have been hospitalized with influenza. A patient from your clinic, Patient Name (DOB: MM/DD/YYYY), was reported to us as having been hospitalized with influenza beginning on MM-DD-YYYY. We are trying to obtain immunization history on all hospitalized patients and would appreciate your help in completing the information below for this patient. If this was not a patient seen by you or another provider at your clinic, please mark “Unknown” for question 1 or 2 below. Please fax the completed form to XXX-XXX-XXXX. For any questions, please contact <PI/SO>, at XXX-XXX-XXXX. Thank you in advance for your help. Investigation of these cases falls within the scope of public health surveillance. The Health Insurance Portability and Accountability Act (HIPAA) does NOT prohibit your reporting this information to public health authorities (see http://aspe.hhs.gov/admnsimp/PL104191.htm, Section 1178 (b)). FOR CHILDREN For mothers of patients < 6 months: 1. Did the patient’s mother receive the influenza Yes No Unknown vaccine during fall or winter of the current influenza season? 1a. If YES, specify mother’s vaccine type: Injected vaccine --Trivalent inactivated influenza vaccine (TIV) Nasal spray -- Live-attenuated influenza vaccine (LAIV) 2. Did the patient receive the influenza vaccine during Yes No Unknown fall or winter of the current influenza season? 2a. If YES, please specify vaccine type: Injected vaccine --Trivalent inactivated influenza vaccine (TIV) Nasal spray -- Live-attenuated influenza vaccine (LAIV) 2b. Indicate number of doses: 1 2 Unknown 2c, For each dose, specify the date given 1) _____-_____-________ (MM-DD-YYYY) 2) _____-_____-________ (MM-DD-YYYY) 3. If patient was < 9 years of age at hospitalization did the patient receive influenza vaccine in any previous seasons? Yes No Unknown 4. Did the patient receive the pneumococcal vaccine ? Yes No Unknown 4a. If YES, please indicate the number of doses and when administered: 1 doses administered: ______/______/______ (mm/dd/yyyy) 2 doses administered: ______/______/______ (mm/dd/yyyy) 3 doses administered: ______/______/______ (mm/dd/yyyy) 4 doses administered: ______/______/______ (mm/dd/yyyy) 42 To help us complete the medical information about your patient, could you please provide us with their height and weight if this information was obtained within 6 months before their hospitalization. 5. HEIGHT: _________ inches centimeters WEIGHT: _________ pounds kilograms To help us complete the demographic information about your patient, could you please provide us with their race and ethnicity. 6. Race (check only one): White Am Indian or Alaska Native 7. Ethnicity (check one) Black or African American Multiracial Hispanic or Latino Asian/Pacific Islander Not specified Non-Hispanic or Latino Not Specified 43 Date: [current date] Dear Dr. [LastName]: The [State/Local Health Department], in collaboration with the Centers for Disease Control and Prevention, are tracking patients who have been hospitalized with influenza. A patient from your clinic, Patient Name (DOB: MM/DD/YYYY), was reported to us as having been hospitalized with influenza beginning on MM-DD-YYYY. We are trying to obtain immunization history on all hospitalized patients and would appreciate your help in completing the information below for this patient. If this was not a patient seen by you or another provider at your clinic, please mark “Unknown” for question 1 below. Please fax the completed form to XXX-XXX-XXXX. For any questions, please contact <PI/SO>, at XXX-XXX-XXXX. Thank you in advance for your help. Investigation of these cases falls within the scope of public health surveillance. The Health Insurance Portability and Accountability Act (HIPAA) does NOT prohibit your reporting this information to public health authorities (see http://aspe.hhs.gov/admnsimp/PL104191.htm, Section 1178 (b)). FOR ADULTS 1. Did the patient receive any influenza vaccine during fall or winter of the current influenza season? Yes No Unknown 1a. If YES, please specify vaccine type: Injected vaccine --Trivalent inactivated influenza vaccine (TIV) Nasal spray -- Live-attenuated influenza vaccine (LAIV) 1b. If injected vaccine (TIV), specify type: Regular IM High dose IM Intradermal TIV type unknown 2. Did the patient receive any type of pneumococcal vaccine at any age? Yes No Unknown 2a. If YES, please indicate the number of doses and when administered: 1 doses administered: ______/______/______ (mm/dd/yyyy) 2 doses administered: ______/______/______ (mm/dd/yyyy) To help us complete the medical information about your patient, could you please provide us with their height and weight if this information was obtained within 6 months before their hospitalization. 3. HEIGHT: _________ inches centimeters WEIGHT: _________ pounds kilograms To help us complete the demographic information about your patient, could you please provide us with their race and ethnicity. 4. Race (check only one): White Am Indian or Alaska Native 6. Ethnicity (check one) Black or African American Multiracial Hispanic or Latino Asian/Pacific Islander Not specified Non-Hispanic or Latino Not Specified 44 Contacting Patients, Proxies or Parents/Guardians for Vaccination Status All participating FluSurv-NET sites may contact patients, proxies or patients’ parent/guardian (family member) to obtain patient or maternal influenza and pneumoccocal vaccination history if this information is not available from medical chart review, physician records or state vaccination registries. If patients are deceased or unable to answer for some reason an interview will be held with the patient’s proxy (e.g., spouse, caregiver, or next of kin). The need for a proxy will be ascertained during the phone interview, unless the medical record admission note indicates the need for and identifies a proxy. Participating sites will interview patients, proxies or family members by phone. Sites will use the following methods to try to locate patients or family members: 1) medical charts, 2) laboratory records, 3) directory assistance (“411”) or phone books, and/or 4) internet phone/address searches (including name and address/reverse directories). If the patient is deceased or unable to answer the questions for some other reason, a proxy will be identified through 1) medical charts, 2) long term care facility records (if applicable), and/or 3) contact with someone living at the patient’s residence. Sites will try to identify the family member or friend who is most familiar with the patient’s medical history during the phone interview to serve as the proxy. If the proxy’s name is found in the medical or long term care facility record, or given to a project staff member by someone living at the patient’s house, but a correct phone number is not given, project staff will attempt to find a phone number from 1) directory assistance and/or 2) the internet. Once a correct phone number is identified, sites will make multiple attempts to reach the patient, proxy or family member. These attempts should include calling during different daytime periods during the week and weekend. Sites will stop trying to call a case patient, proxy or family member if they cannot locate a correct phone number after using the search methods listed above or if successful contact is not made after three attempts at what appears to be a correct number. Once a patient, proxy or family member is successfully contacted a project staff member will use a script to explain the evaluation/surveillance project and will obtain verbal informed consent, if required by local IRB to participate. A project staff member will then ask the patient a series of questions (phone scripts provided below) about receipt of influenza vaccine prior to their influenza hospitalization. If case race/ethnicity and/or height and weight information is missing or unknown after review of the medical chart and the patient, proxy or family member is going to be contacted to obtain vaccination history, it is appropriate to query this information during the phone interview. Informed Consent Informed consent in some FluSurv-NET sites may not be required because influenza hospitalization is a reportable condition in that state. Those FluSurv-NET sites should make modifications to the content of informed consent and its process as allowed by statutory authority and local IRB requirements. 45 Consent Form (for patient/proxy interview ONLY) Influenza Hospitalization Surveillance Project VERBAL CONSENT FORM Hello. My name is __________ from the _____[state] Department of Public Health. May I speak to ______ [patient’s name /parent of [child’s name] ] . We are working with the Centers for Disease Control and Prevention and other health departments to learn more about influenza disease or the flu. To do this, we are talking to people who have been in the hospital with the flu. We want to look at things that may affect their illness and whether they were vaccinated against the flu. Because you/your child [or NAME if speaking with proxy] were in the hospital for the flu beginning on _______[day admitted], I would like to ask you a few questions about whether you/your child [or NAME if speaking with proxy] received the flu vaccine this season. This will take about five minutes. Your participation is voluntary and if you choose to refuse it will not affect any medical care or benefits you receive. All of your responses will be kept confidential as much as the law allows. You may refuse to answer any questions and may stop at any time. This information will help [State/Local Health Department] and CDC better describe influenza-associated hospitalizations. Additionally, this information may help us improve vaccination recommendations for flu and better protect the public’s health. There is no other benefit to you for answering these questions. There is also no risk to you. If you have any questions about the study, you may call _____[state contact] at the Department of Public Health at XXX-XXX-XXXX. Do you have any questions before I begin? □ Yes May I continue with this interview? □ No If YES, go to Appendix D. If NO: Thank you for your time. Have a good day. Name of person obtaining verbal consent: Date: _______________________________ _______________________________ Flesch- Kincaid: 7.7 Case and Proxy Identifying Information Influenza Hospitalization Surveillance Project Patient’s: Last name________________ First name____________ Initial__ Date of birth: ____/____/______ Phone_____________ Proxy’s: Last name________________First name____________ Initial__ Phone_________________ Relationship to case patient _________________________ Note to collaborators: This is for your records only. Do not send this information to CDC. Keep this information in a secure locked place. 46 Formulario de Consentimiento (Para paciente, apoderado, para los padres/guardián entrevista SOLAMENTE) Gripe Hospitalización en El Proyecto de Vigilancia Formulario de Consentimiento Verbal Hola. Mi nombre es ________, trabajo con el departamento de Salud Pública del estado de ___. ¿Puedo hablar con ___ [nombre del paciente /uno de los padres de [nombre de niño/a]]? Estamos trabajando con los Centros para el Control y la Prevención de Enfermedades y otros departamentos de salud para aprender más acerca de la gripe. Para hacer esto, estamos hablando con gente que ha estado en el hospital con la gripe. Deseamos averiguar más sobre las cosas que pueden afectar la enfermedad, incluyendo las medicinas que toma, y si usted fue vacunado contra la gripe. Ya que usted/ su hijo/a (o nombre de la persona si es un apoderado) estuvo en el hospital con la gripe desde _____ (fecha de hospitalización), me gustaría hacerle algunas preguntas sobre si usted/su hijo/a [o nombre de la persona si es un apoderado] ha recibido la vacuna contra la gripe durante esa temporada. Estas preguntas tomarán aproximadamente cinco minutos. Su participación es voluntaria y si usted decide negarse no afectará ninguna atención médica o beneficios que usted recibe. Todas sus respuestas se mantendrán confidencialmente en la medida que lo dispone la ley. Usted puede negarse responder a cualquier pregunta y parar en cualquier momento. Ésta información ayudará al Departamento de Salud Pública y CDC a describir hospitalizaciones asociadas con la influenza. Además, esta información puede ayudarnos a mejorar las recomendaciones para vacunaciones contra la influenza y a proteger la salud de la población. No hay otro beneficio para usted por contestar estas preguntas. Tampoco hay riesgo alguno para usted. Si tiene alguna pregunta sobre el estudio, puede ponerse en contacto con el Dr. [contacto en el estado] en el Departamento de Salud Pública al teléfono (xxx) xxx-xxxx. ¿Tiene usted alguna pregunta antes que comience? □ Si ¿Puedo seguir con la entrevista? □ No If YES, go to Appendix E. If NO: Muchas gracias por su tiempo. Que tenga un buen día. Name of person obtaining verbal consent: _________________________ Date: _________________________ Case and Proxy Identifying Information Influenza Hospitalization Surveillance Project Patient’s: Last name________________ First name______________ Initial_______ Date of birth: ____/____/______ Phone________________________ Proxy’s: Last name________________First name____________ Initial__ Phone_________________ Relationship to case patient _________________________ Note to collaborators: This is for your records only. Do not send this information to CDC. Keep this information in a secure locked place. 47 CaseID ____________ Birth date: ___/___/_____ MM/DD/YYYY Obtain verbal consent, Appendix C, before proceeding. I’d like to ask you a few questions about _____[patient’s name/ child’s name]’s vaccination history before [he/she] was hospitalized for influenza or the flu. These questions will take about five minutes to answer. FOR CHILD < 6 MONTHS: 1) Did [you (if speaking to patient’s mother)/patient’s mother] receive the influenza vaccine during fall or winter of the current influenza season? Yes (go to Q1a) No (go to Q2) Unknown (go to Q2) 1a) If yes, what vaccine type did [you/the patient’s mother] receive? Shot [Injected vaccine --Trivalent inactivated influenza vaccine (TIV)] Spray [Nasal spray -- Live-attenuated influenza vaccine (LAIV)] Unknown 2) At any time, did [your child/patient’s name] receive the pneumonia vaccine [may need to read: pneumococcal, PCV(7), PCV(13), or Prevnar®]? Yes No Unknown [If YES, continue to Q2a; if NO/UNKNOWN then proceed to race/ethnicity (Q3), if needed] 2a) Can you tell me the dates [your child's/patient’s name] received the pneumonia vaccine? 1) _____-_____-________ [MM-DD-YYYY] 2) _____-_____-________ [MM-DD-YYYY] 3) _____-_____-________ [MM-DD-YYYY] 4) _____-_____-________ [MM-DD-YYYY] 3) Can you tell me what is [your child’s/patient’s name] race (check all that apply)? White Black or African American Asian/Pacific Islander American Indian or Alaska Native Multiracial, unspecified Not specified (refused) Are you / they….? Hispanic or Latino 48 Non-Hispanic or Latino Not Specified (refused to answer) FOR CHILD 6 MONTHS OR OLDER: 1. Since September [flu season year], did [you / child’s name] receive a flu shot or flu vaccine? This vaccine is offered every year to protect against the flu. Yes (go to Q1a) No (go to Q2) Unknown (go to Q2) 1a) For each dose received, can you tell me the date [you/child’s name] received flu vaccine? 1) _____-_____-________ [MM-DD-YYYY] 2) _____-_____-________ [MM-DD-YYYY] 1b) Did [you/child’s name] receive a shot or was it sprayed into their nose? Shot [Injected vaccine --Trivalent inactivated influenza vaccine (TIV)] Spray [Nasal spray -- Live-attenuated influenza vaccine (LAIV)] Unknown [If patient is less than 9 years of age proceed to Q2; if patient is 9 years of age or older, proceed to Q3] 2). Did [you/child’s name] receive influenza vaccine in any previous years? Yes No Unknown 3). At any time, did [you/child’s name] receive the pneumonia vaccine [may need to read: pneumococcal, PCV(7), PCV(13), or Prevnar®]? Yes No Unknown [If YES, continue to Q3a; if NO/UNKNOWN, proceed to race/ethnicity (Q4) and height/weight questions (Q5), if needed] 3a) Can you tell me the dates [you/child’s name] received the pneumonia vaccine? 1) _____-_____-________ [MM-DD-YYYY] 2) _____-_____-________ [MM-DD-YYYY] 3) _____-_____-________ [MM-DD-YYYY] 4) _____-_____-________ [MM-DD-YYYY] [If medical record is incomplete then ask race/ethnicity(Q4); otherwise skip to Q5.] 4) Can you tell me what is [your/child’s name] race (check all that apply)? White 49 Multiracial, unspecified Black or African American Not specified (refused) Asian/Pacific Islander Native Hawaiian or Other Pacific Islander American Indian or Alaska Native Are you / they….? Hispanic or Latino Non-Hispanic or Latino Not Specified (refused to answer) [If medical record is incomplete to calculate BMI, then ask height and weight; Do not ask BMI questions if patient is pregnant or less than 2 years of age] 5. Can you tell me [your/child’s name] height and weight? HEIGHT: _____ Inches Centimeters Unknown height WEIGHT: _____ Pounds Kilograms Unknown weight FOR ADULTS: 1. Since September [flu season year], did [you/patient’s name] receive a flu shot or flu vaccine? This vaccine is offered every year to protect against the flu. Yes (go to Q1a) No (go to Q2) Unknown (go to Q2) 1a) Can you tell me the date [you/patient’s name] received flu vaccine? 1) _____-_____-________ [MM-DD-YYYY 1b) Did [you/patient’s name] receive a shot or was it sprayed into your nose? Shot [Injected vaccine --Trivalent inactivated influenza vaccine (TIV)] Spray [Nasal spray -- Live-attenuated influenza vaccine (LAIV)] Unknown [If injected vaccine/trivalent inactivated influenza vaccine (TIV), go to 1c; if not then skip to 2] 1c) What type of injected vaccine did [you/patient’s name] receive? Regular IM High dose IM Intradermal 50 TIV type unknown 2) At any time, did [you/patient’s name) receive the pneumonia vaccine [may need to read: pneumococcal, Pneumovax®]? Yes No Unknown [If YES, continue to Q2a for patient’s less than 65 years and Q2b for patients 65 years and older; if NO/UNKNOWN proceed to race/ethnicity (Q3) and height/weight questions (Q4), if needed] 2a) Can you tell me the dates [you/patient’s name] received the pneumonia vaccine? 1) _____-_____-________ [MM-DD-YYYY] 2) _____-_____-________ [MM-DD-YYYY] 3) _____-_____-________ [MM-DD-YYYY] 4) _____-_____-________ [MM-DD-YYYY] 2b) Did [you/patient’s name] receive the pneumonia vaccine within the last five years? Yes No Unknown [If medical record is incomplete then ask race/ethnicity (Q3); otherwise skip to Q4] 3) Can you tell me what is [your/patient’s name] race (check all that apply)? White Multiracial, unspecified Black or African American Not specified (refused) Asian/Pacific Islander Native Hawaiian or Other Pacific Islander American Indian or Alaska Native Are you / Is he/she….? Hispanic or Latino Non-Hispanic or Latino Not Specified (refused to answer) [If medical record is incomplete to calculate BMI, then ask height and weight; Do not ask BMI questions if patient is pregnant ] 4) Can you tell me [your/patient’s name] height and weight? HEIGHT: _____ Inches Centimeters Unknown height 51 WEIGHT: _____ Pounds Kilograms Unknown weight THE END. These are all my questions. Do you have any questions for me? [If yes, answer.] Thank you for your time. 52 CaseID ________________________ Birth date: ___/___/_____ MM/DD/YYYY Obtain verbal consent, Appendix D, before proceeding. Me gustaría preguntarle unas preguntas acerca de la historia de vacunación de [nombre del paciente/ hijo/a] antes de que ingresara al hospital con el virus de la gripe. Contestar estas preguntas tomará alrededor de cinco minutos. PARA NIÑOS MENORES DE SEIS MESES DE EDAD 1) ¿Recibió [Ud. (si está hablando con la madre)/ la madre del paciente] la vacuna contra la gripe durante el otoño o el invierno de esta temporada de gripe? Sí (avance a 1a) No (avance a 3) Desconocido (avance a 3) 1a) Si la respuesta es “sí”, ¿cuál vacuna recibió [Ud./ la madre del paciente]? Inyección [Vacuna inyectada-Trivalent inactivated influenza vaccine (TIV)] Espray a través de la nariz [Vacuna viva atenuada-Live attenuated influenza vaccine (LAIV)] Desconocido 2) ¿En cualquier momento de su vida, ha recibido [el paciente/ su niño/a] la vacuna contra el neumococo (neumonía) [PCV(7), PCV(13), o Prevnar®]? Sí No Desconocido [Si la respuesta es “sí”, avance a 2a, si no, avance a 3] 2a) ¿Puede usted decirme las fechas en que [el paciente/ su hijo/a] recibió la vacuna contra el neumococo? 1) _____-_____-________ [MM-DD-AAAA] 2) _____-_____-________ [MM-DD-AAAA] 3) _____-_____-________ [MM-DD-AAAA] 4) _____-_____-________ [MM-DD-AAAA] 3) ¿Puede usted decirme cual es la raza de [el paciente/ su hijo/a]? Blanca Negra o afroamericana Asiática o Nativa de Hawai o de otra isla del Pacífico Indioamericana o nativa de Alaska 53 Multirracial Se negó a contestar ¿Es usted/su hijo/a…? Hispano o Latino No Hispano o Latino Se negó a contestar PARA NIÑOS DE SEIS MESES O MAS DE EDAD 1) ¿Desde septiembre de [año], ha recibido [usted/nombre de niño/a] una inyección contra la gripe o una vacuna contra la gripe? Esta vacuna se ofrece cada año para proteger contra la gripe. Sí (avance a 1a) No (avance a 2) Desconocido (avance a 2) 1a) ¿Para cada dosis recibida, puede usted decirme la fecha en que [Ud. /su niño/a] recibió la vacuna contra la gripe? 1) _____-_____-________ [MM-DD-AAAA] 2) _____-_____-________ [MM-DD-AAAA] 1b) ¿Cuál vacuna recibió [Ud./ el paciente]? Inyección (Vacuna inyectada-Trivalent inactivated influenza vaccine (TIV)] Espray a través de la nariz [Vacuna viva atenuada-Live attenuated influenza vaccine (LAIV)] Desconocido [Avance a 2 si el paciente tiene menos de 9 años de edad o a 3 si el paciente tiene 9 o más años de edad] 2) ¿Recibió [Ud./ su niño/a] la vacuna contra la gripe en algún año anterior? Sí No Desconocido 3) ¿En cualquier momento de su vida, ha recibido [Ud./ su niño/a] la vacuna contra el neumococo (neumonía) [PCV(7), PCV(13), o Prevnar®]? Sí No Desconocido [Si la respuesta es “sí”, avance a 3a, si no, avance a las preguntas 4 y 5] 3a) ¿Puede usted decirme las fechas en que [Ud./ su hijo/a] recibió la vacuna contra el neumococo? 1) _____-_____-________ [MM-DD-AAAA] 54 2) _____-_____-________ [MM-DD-AAAA] 3) _____-_____-________ [MM-DD-AAAA] 4) _____-_____-________ [MM-DD-AAAA] [Si falta la información pregunte sobre la raza; si no, avance a 5] 4) ¿Puede usted decirme cual es la raza de [el paciente/ su hijo/a]? Blanca Negra o afroamericana Asiática o Nativa de Hawai o de otra isla del Pacífico Indioamericana o nativa de Alaska Multirracial Se negó a contestar ¿Es usted/su hijo/a…? Hispano o Latino No Hispano o Latino Se negó a contestar [Si el paciente tiene dos años de edad o más y le falta la información para el cálculo del índice de masa corporal pregunte sobre la altura y el peso; si no, avance al FINAL] 5. ¿Puede decirme la estatura y peso [suyo/ de su hijo/a]? ESTATURA: _____ Pulgadas Centímetros No sabe PESO: _____ Libras Kilogramos So sabe PARA ADULTOS: 1) ¿Desde septiembre de [año], ha recibido [usted/ nombre del paciente] una inyección contra la gripe o una vacuna contra la? Esta vacuna se ofrece cada año para proteger contra la gripe. Sí (avance a 1a) No (avance a 2) Desconocido (avance a 2) 1a) ¿Para cada dosis recibida, puede usted decirme la fecha en que [usted /nombre del paciente] recibió la vacuna contra la gripe? 1) _____-_____-________ [MM-DD-AAAA] 1b) ¿Cuál vacuna recibió [usted/ nombre del paciente]? Inyección (Vacuna inyectada-Trivalent inactivated influenza vaccine (TIV)] Espray a través de la nariz [Vacuna viva atenuada-Live attenuated influenza vaccine (LAIV)] Desconocido 55 [Si la respuesta incluye la vacuna inyectada, avance al 1c; si no, avance a 2] 1c) ¿Qué tipo de vacuna inyectada recibió? Intramuscular Vacuna de alta dosis (intramuscular) Vacuna intradérmica Vacuna inyectada desconocida 2) ¿En cualquier momento de su vida, ha recibido [usted/ nombre del paciente ] la vacuna contra el neumococo (neumonía) [PCV(7), PCV(13), o Prevnar®]? Sí No Desconocido [Si la respuesta es “sí”, avance a 2a si el paciente tiene menos de 65 años de edad o a 2b si el paciente tiene 65 o más años de edad; si no, avance a las preguntas 3 y 4] 2a) ¿Puede usted decirme las fechas en que [usted/ nombre del paciente] recibió la vacuna contra el neumococo? 1) _____-_____-________ [MM-DD-AAAA] 2) _____-_____-________ [MM-DD-AAAA] 3) _____-_____-________ [MM-DD-AAAA] 4) _____-_____-________ [MM-DD-AAAA] 2b) ¿Recibió [usted/nombre del paciente] la vacuna contra en neumococo en los últimos cinco años? Sí No Desconocido [Si falta la información pregunte sobre la raza; si no, avance a 4] 3) ¿Puede usted decirme cual es la raza [suya/ del paciente]? Blanca Negra o afroamericana Asiática o Nativa de Hawai o de otra isla del Pacífico Indioamericana o nativa de Alaska Multirracial Se negó a contestar ¿Es [usted/ nombre del paciente]…? Hispano o Latino No Hispano o Latino Se negó a contestar 56 [Si le falta la información para el cálculo del índice de masa corporal pregunte sobre la altura y el peso; si no, avance al FINAL] 4) ¿Puede decirme la estatura y peso [suyo/ del paciente]? ESTATURA: _____ Pulgadas Centímetros No sabe PESO: _____ Libras Kilogramos So sabe EL FIN. Estas fueron todas mis preguntas. ¿Tiene usted alguna pregunta para mí? [Si sí, respóndalas]. Muchas gracias por su tiempo. 57