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Pandemic Influenza > Lab Information Lab Information

Guidelines for Reporting Domestic Suspected Human Cases of Avian Influenza A (H5) or Other Potential Pandemic Strain and the Collection and Shipping of Specimens for Testing


This document contains detailed information on reporting, collecting, shipping, and testing of clinical specimens.

In collaboration with local health departments and the CDC, the Indiana State Department of Health (ISDH) is collecting information on suspected human influenza A (H5) cases in the State of Indiana. This effort is intended to enhance current influenza surveillance for early identification of patients with influenza A (H5) infection. The CDC has approved the ISDH Laboratory for influenza virus testing on patients meeting the influenza A (H5) surveillance criteria below.

Influenza A (H5) Surveillance Criteria

  1. Patient is hospitalized and has:
    1. radiographically confirmed pneumonia, acute respiratory distress syndrome (ARDS), or other severe respiratory illness for which an alternative diagnosis has not been established, and
    2. a history of travel within 10 days of symptoms onset to a country with  documented H5N1 avian influenza infections in poultry or humans.

Ongoing listings of countries affected by avian influenza are available from the World Organization for Animal Health Web site at http://www.oie.int/downld/AVIAN%20INFLUENZA/A_AI-Asia.htm.
OR

  1. Patient is hospitalized or ambulatory and has:
    1. documented temperature of >100.4°F (>38°C), and
    2. cough, sore throat, or shortness of breath, and either
    3. within 10 days prior to onset of symptoms, history of contact with:
      1. poultry or domestic birds (e.g., visited a poultry farm, a household raising poultry, or a bird market) in an affected country

OR

      1. a patient with known or suspected influenza A (H5) infection.

Patients meeting the influenza A (H5) surveillance criteria may be tested at the ISDH Laboratory for influenza A or influenza A (H5) if laboratory capacity is available.  Specimens will be accepted with prior approval from a member of the ISDH Epidemiology Resource Center Surveillance Team (ERC ST), provided there is an epidemiologic need.

HIPAA

The ISDH, in cooperation with the CDC, is conducting these activities in its capacity as a public health authority, as defined by the Health Insurance Portability and Accountability Act (HIPAA). Health care providers and health departments may, therefore, disclose protected health information to health departments and the CDC without individual authorization. The information being requested represents the minimum necessary to carry out the public health purposes of this project pursuant to 45 CFR §164.514(d) of the Privacy Rule and protected health.

Reporting Suspect Cases of Human Influenza A (H5)

  1. Initial Report

Prior to submitting a case report form or suspect specimen, health care workers should notify ISDH ERC officials immediately.  Health care workers requesting testing of a specimen should contact the ERC at 1.866.233.1237.  This number is available 24 hours a day, 7 days a week.


The ISDH duty officer will notify a member of the ERC ST, who
will complete the emerging influenza screening form to determine if the specimen should be submitted to the ISDH Laboratory for testing.  If the case screening form indicates that the specimen should be sent to the ISDH Laboratory for testing, a member of the ERC ST will assign an exclusive ID number to the specimen and contact the appropriate district field staff.  This ID number MUST be on the submission form before the ISDH Lab will test the specimen.  The ERC ST member will then contact the ISDH Laboratory to alert them of the suspect specimen to be tested.  The ERC ST member should assign the state ID number and provide that ID number to the Lab.  The ERC ST member should also provide the Lab with the specimen’s shipping date and time.  The Laboratory should notify the ERC ST member when the specimen arrives at the ISDH Laboratory.  The county health department will be notified when a suspect specimen is sent to the ISDH Lab.  Specimens will not be tested for H5 unless the state ID number is on the submission form.
           

  1. Written Materials Case Report Form
    1. Following the initial telephone report, fax the initial case report screening form and the lab submission form with the exclusive ID number to the ISDH ERC at 317.234.2812.
      1. Please include the case ID number, contact information, and a cover sheet with the header “ATTN: Influenza A (H5N1) case reporting”. 
      2. Rapid return of information is of high priority; complete as much of the case report form as possible. 
    2. The ISDH will then transmit the reports to CDC within 3 to 5 business days of first contact, per CDC’s policy. State health departments may request help from the CDC in completing the case report by contacting the CDC Flu Hotline at 770.488.7100.

  1. Laboratory Procedures, Specimen Collection and Shipment

The following human respiratory specimens are acceptable for suspected avian influenza testing:  nasopharyngeal swabs and aspirates, oropharyngeal aspirates or washes, throat swabs, tracheal aspirates or broncheoalveolar lavage. Nasopharyngeal swabs and aspirates are the samples of choice.  Tissue specimens are not recommended at this time.

Swab specimens should be collected using swabs with a Dacron® tip and an aluminum or plastic shaft and should be submitted in viral transport medium.  M5 is the transport medium of choice.   Swabs with calcium alginate or cotton tips and wooden shafts are unacceptable.

Samples should be transported by Priority Overnight Shipping or courier to the ISDH Lab, refrigerated and collected within the past 24 hours. 

Ship/Deliver to:

Indiana State Department of Health Laboratories
Virology Laboratory
550 West 16th. Street
Suite B
Indianapolis, IN 46202

Please call 866.233.1237 (Epidemiology) and 317.233.8000 (Laboratory) before submitting a sample.
Protocols for standard interstate shipment of etiologic agents should be followed.  These standards are available at http://www.cdc.gov/od/ohs/biosfty/shipregs.htm.  All shipments must comply with current DOT/IATA shipping regulations.
Reports will be returned to the submitter indicated on the submission form.  This can be a physician, clinic or hospital, or reference laboratory.

Influenza A (H5) Domestic Case Screening Form Instructions

Section 1.  Reported By

Date reported to state or local health department: Date case was first reported to the state or local health department.
State/local Assigned Case ID: Case number used by local jurisdiction to identify case.
Last Name, First Name, State, Affiliation, Email, Phone 1, Phone 2, Fax: Contact information for the state or local official responsible for following the case.

Section 2. Patient Information

HIPAA Note: Please note that CDC is conducting these activities in its capacity as a public health authority, as defined by the Health Insurance Portability and Accountability Act (HIPAA). Health care providers and health departments may, therefore, disclose protected health information to CDC without individual authorization. The information being requested represents the minimum necessary to carry out the public health purposes of this project pursuant to 45 CFR §164.514(d) of the Privacy Rule, and protected health information will not be disseminated. Nevertheless, individual local and state health department privacy policies may vary and should be followed accordingly. 
Age at onset: If patient is less than one month old, round up age to one month. 
Race: Please choose only one race. Multiracial patients should indicate race most closely identified with. 
Ethnicity: Please answer this question in addition to the Race question above.

Section 3. Optional Patient Information

Last Name, First Name: Please see HIPAA note above. The patient’s initials should be listed if state or local policies preclude release of the patient’s name.

Section 4. Signs and Symptoms (Self-explanatory)

Section 5. Travel/Exposures

Section 5A: The list of affected countries may change. CDC will notify state and local health officials if the list of affected countries changes. In addition, a current listing of affected Asian countries is posted on the World Organization for Animal Health Web site:
http://www.oie.int/downld/AVIAN%20INFLUENZA/A_AI-Asia.htm. 
Transit through an airport (i.e., patient did not leave the airport) within an affected country does not count as exposure in that country. If patient did not travel to any countries affected by avian influenza outbreaks within 10 days prior to illness onset, skip to Section 6 on Exposure for Non Travelers.


Section 5E: Did the patient visit or stay in the same household with a suspected human influenza A (H5) case?  Clinical and epidemiologic criteria for a suspect case in an affected country: Any person with radiographically confirmed pneumonia, acute respiratory distress syndrome (ARDS), or other severe respiratory illness (regardless of poultry exposure)
OR
Any person with all of the following:

  1. documented temperature of >100.4°F (>38°C), and
  2. cough, sore throat, or shortness of breath; and
  3. history of contact with:
    1. poultry or domestic birds (e.g., visited a poultry farm, a household raising poultry, or a bird market), or
    2. Anyone hospitalized or died of a flu-like illness.

Section 6. Exposure for Non Travelers  [See clinical and epidemiologic criteria for influenza A (H5) above]

Section 7. State and local level influenza test results
Check type of specimen, date of specimen collection, type of testing, and results for tests conducted at the state and/or local level.

Section 8. List Specimens sent to the CDC
Check type(s) of specimen being sent (i.e., clinical material, extracted RNA, or viral isolate).

List specimen source [i.e., serum (acute), serum (convalescent), nasopharyngeal (NP) swab or aspirate, broncheoalveolar lavage specimen (BAL), oropharyngeal (OP) swab, tracheal aspirate, or tissue (specify source)], and dates collected and sent. 
Note: Please list acute and convalescent sera as separate specimens.

Section 9. Case Notes
Please include any pertinent information not covered elsewhere in the form in this section.

The Human Influenza A (H5) Domestic Case Screening Form can be found on the CDC Web site: http://www.ncid.cdc.gov/flu/H5Forms/H5CSF_Revised27Feb04.pdf .