Test-level Data

Form Approved

OMB No. 0920-xxxx

Expiration Date 00/00/0000

Hepatitis Testing and Linkage to Care (HEPTLC) Monitoring & Evaluation System

Minimum Test-Level Data Variables Monthly

Attachment 4

Public reporting burden of this collection of information is estimated to average 12 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: OMB-PRA (0920-xxxx)

Data Element:	Comments:
Test Site Information
Name of test site
Type of test site	(IDU, CHC, Other)
Contact information of test site	Address, Phone #, Fax #
Demographic Information
Patient ID
Patient's state of residence
Country of origin/county of birth
Date of Birth/Age	00/00/0000, Age (month, year)
Gender (Current Gender Identity)	Male, Female, Transgender
Race	AA, W, Asn, NH/PI, AI/AN, Oth
Ethnicity	Hsp, Non-Hsp, Oth
Vaccination History
Hep A vaccine	Ever, # of dose
Hep B vaccine	Ever, # of dose
Lab Information
Lab Name (The lab that performed the test)
Patient ID
Date of test
Test Technology
Test Results
Hep C
Hepatitis C antibody (HCV Ab)	Date, Positive, Negative, Indeterminate, Invalid
Hepatitis C RNA (HCV-RNA)	Date, Positive, Negative, Indeterminate, Invalid
Quantitative HCV RNA	Result, Date (Category B - ECHO option)
HCV Genotype	Result, Date (Category B - ECHO option)
Hep B
Hepatitis B core antibody	Data, Positive, Negative, Indeterminate, Invalid
Hepatitis B surface antigen	Data, Positive, Negative, Indeterminate, Invalid
Diagnosis	Chronic HBV, Chronic HCV

Post-Test Follow -Up
Test results provided	yes, no. If yes, date. If no, why?
post-test counseling provided	yes, no. If yes, date. If no, why?
Linkage to care	yes, no, date*
Antiviral Therapy (AVT)	Regimen, Date (Category B - ECHO option)
Reported to surveillance	yes, no, date*
Risk Factors
Hep C
Persons Who Inject Drugs (PWIDs) and persons who use non-injection drugs
Persons born from 1945 through 1965
HIV-positive [Self-Report Positive (SRP)]
Hep B
Persons born in countries with intermediate or high prevalence of HBV infection
Other at-risk populations, including PWID and MSM
Contacts of hepatitis B positive person
HIV-positive (SRP)
If female, is client pregnant?	yes, no, don't know, declined, not asked
*NOTE*
All personal identifying information, such as Name (FN, LN, MN), SSN, Address at Diagnosis and/or Current Address, Phone # should NOT be submitted to CDC