Reporting Severe Adverse Events Associated with Treatmen

Form Approved

OMB No. 0920-0773

Expiration Date: 01/31/2018

Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI)

National Surveillance for Severe Adverse Events (NSSAE) Data Collection Form

Public reporting burden of this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; Attn: PRA (P920-0773)

Information contained on this form which would permit identification of any individual has been collected with a guarantee that it will be held in strict confidence, will be used for surveillance purposes, and will not be disclosed or released without the consent of the individual in accordance with Section 308(d) of the Public Health Service Act (42 U.S.C. 242m).

Part 1. To be completed by the medical clerk when a person’s condition is suspected to be related to LTBI treatment.

State: ________

Assigned Case Identification Number: (2digit state abbreviation-5 digit county FIPS-001) _____________

Form completed by:

CDC phone interview _____ CDC on-site investigator ______ On-site local staff _____

Name of person who reported the case: _____________________________________

Phone number: _________________________________________________________

Corresponding health department: _________________________________________

Name of contact in corresponding health department (if different than above): ___________________ Phone number: _____________________________

Date CDC notified __________ Reported to FDA/MedWatch: Yes_____ No _____

SOURCE OF REPORT

Name of setting where TLTBI was prescribed: _____________________________

County/city/state: _____________________________________________________

Facility type: Health department _____ Private provider _____ HMO _____

Other (specify): _________________________________________________________

Location where severe adverse event was detected: Health department _____

Private provider _____ HMO _____

Other (specify): _________________________________________________________

BASIC PATIENT AND ILLNESS DESCRIPTION

Age at time of starting LTBI treatment: ____ Sex: Male____ Female_____

Ethnicity (select one): Hispanic or Latino_____ Not Hispanic or Latino: ________

Race (select one or more): American Indian/Alaska Native _______ Asian (specify)_____________

Black/African American ______Native Hawaiian/Other Pacific Islander (specify) _________________

White __________

Unknown (Please explain): _____________________________________________

Country of birth: United States: Yes _______ No ________

Other countries Yes _______ No ________ If yes, Specify __________________

Year arrived in United States ___________________________

Residence in other country/countries: Yes ________ No ___________

Identify country/countries: _____________________________________________

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