Reporting Severe Adverse Events Associated with Treatmen

Form Approved

OMB No. 0920-0773

Expiration Date: xx/xx/xxxx

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

Public reporting burden of this collection of information is estimated to average 4 hours 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 (0920-0773)

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 2. To be completed by the nurse

*The information requires input from the medical clerk by searching the records of the admitting hospital and other hospitals where the patient might have been evaluated in the past.

Able to speak English? Yes _____ No______

If No, what is the primary language?______________

Preferred language (please answer even if patient speaks English):______________

Language in which follow-up and monitoring visits were conducted___________________________

Adverse event leading to hospitalization or death associated with LTBI treatment:

Anaphylaxis ____ Metabolic acidosis ____ Other, specify _________________

Liver injury ____ Severe dermatitis ____

*Admission to hospital: Yes ______No _____ Unknown _____

If Yes: Date:___________ Date discharged:___________

Reason:______________________________

Severity of adverse event outcome: (Check all that apply)

Still Sick _____ Full recovery _____ Pending _____

Recovery with residual effects _____

Evaluated for possible liver transplant but did not have transplant____________

Liver transplant _____ Unknown _____

Death: Yes ___ No _____ Date died: __________

LTBI DIAGNOSIS AND TREATMENT

Reason(s) for tuberculin skin test (TST)/Interferon Gamma Release Assay (IGRA) for LTBI

Check all that apply:

Contact to person with TB disease _____ Recently (past 2 years)? _____

Risk factors for TB

HIV infection: _____ HIV test date: __________

Diabetes _____ Renal failure _____ Organ transplant _____

Cancer or leukemia _____ Abnormal chest radiograph_____ Chronic steroid administration _____

Immunosuppressive therapy other than chronic steroid administration ____, Specify________

Excessive alcohol use within the past year_______________

Illicit drug use within the past year_____________________

Unknown___________

Congregational setting: Jail ___ Prison ___ Homeless shelter ___

Long-term care facility___ Other, specify__________________

Occupational risk of exposure _____

health care worker______, correctional facility worker______, migrant/seasonal worker__________

Routine/administrative work requirement _____

Foreign born_____

School admission requirement_________

Unknown ______________

TST: Date TST placed: _______ Date TST read: ______

TST result: _____mm Positive___ Negative ___

Converter (documented negative baseline TST)? Yes______ No_____

If IGRA performed, which test?

QuantiFERON TB Gold test (QFT-G)_______

QuantiFERON-TB Gold-in-tube test (QFT-GIT)_____

T-Spot TB test_____________

Date of IGRA performed: __________

Test result*:

Result: Positive_____ Negative_____Indeterminate_____

Quantitative results (list all available values):_____________________________

Converter (documented negative baseline IGRA)? (Yes/No_____

*Refer to the following guideline to interpret results: CDC. Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection --- United States, 2010, MMWR, Recommendations and Reports, June 25, 2010 / 59(RR05);1-25 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5905a1.htm?s_cid=rr5905a1_e

LTBI TREATMENT REGIMEN(S): Please specify the medication(s) taken by the patient.

Medication	Daily or twice weekly	Initial regimen dosage (mg)	Second regimen dosage (mg)
INH
RIF
PZA

Initial TLTBI start date: __________ End date: __________

Second TLTBI start date: __________ End date: __________

Medication lot number: _______________

Medication manufacturer: _____________

Patient’s weight: _____ lbs

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