AttachmentB_TBLISS.Form.pdf

Data Collection Form—Final Annotated TB Latent Infection Surveillance System (TBLISS) – Updated 9/25/2019

Administrative Information

1. Date Reported: // [77995-9]

2. Date Counted

a. MMWR Week: [77991-8]

b. MMWR Year: [77992-6]

3. State Case Number:- - [INV1107]

4. Local Case Number: - - [INV1108]

5. Case Already Counted by Another Reporting Area? [INV1109]

___ {PHC659} Yes, another U.S. reporting area (State case number from other area:

- - ) [INV1110]

___ {PHC660} Yes, another country (Specify country: ____________________________________) [INV1111] ___ {N} No Country Options: Choose from value set PHVS_BirthCountry_CDC

Demographics and Initial Evaluation

6. Reporting Address

a. City: _______________________________________________________________________ [PID-11.3]

b. Is the Patient’s Residence within City Limits? [INV1112]

___ {Y} Yes

___ {UNK} Unknown

c. County: ____________________________________________________________________ [PID-11.9] County Options: Choose from value set PHVS_County_FIPS_6-4

d. ZIP Code: - [PID-11.5]

e. Census Tract (11-digit GEOID): [PID-11.10]

7. Date of Birth: // [PID-7]

8. Sex at Birth [76689-9]

___ {M} Male ___ {F} Female

If Female, Was Patient Pregnant at Time of Diagnostic Evaluation? [77996-7] ___ {Y} Yes ___ {N} No ___ {UNK} Unknown

___ {U} Unknown

Red Text = Generic v2 Black Text = TB & LTBI MMG

Red Text = Generic v2 Data Element Black Text = TB & LTBI MMG Data Element Purple Text = Value Set Codes

9. Ethnicity [PID-22]

___ {2135-2} Hispanic or Latino ___ {2186-5} Not Hispanic or Latino

NOTE: OTH is in the NND vocabulary; however, TB is not interested in that result

10. Race [PID-10]

___ {1002-5} American Indian or Alaska Native ___ {2028-9} Asian (Specify: ___________________________________________________) [DEM153] ___ {2054-5} Black or African American ___ {2076-8} Native Hawaiian or Other Pacific Islander (Specify: ______________________) [DEM153] ___ {2106-3} White ___ {2131-1} Other Race (Specify: _______________________________________________) [32624-9] ___ {UNK} Unknown NOTE: ASKU, NI, NASK, PHC1175 is in the NND vocabulary; however, TB is not interested in these results

Race Specify [DEM153] Options: Choose from value set PHVS_Race_CDC; the TB program is specifically interested in

Asian and Native Hawaiian or Other Pacific Islander details; however all are accepted.

11. Nativity

a. Country of Birth: _____________________________________________________________ [78746-5]

(If NOT United States, Date of First U.S. Arrival: //) [DEM2005]

b. Eligible for U.S. Citizenship/Nationality at Birth (regardless of country of birth)? [DEM2003]

c. Countries of Birth for Primary Guardian(s) (pediatric [<15 years old] cases only)

i. Guardian 1: ___________________________________________________________ [INV1113]

ii. Guardian 2: ___________________________________________________________ [INV1113] Birth Country Specify Options: Choose from value set PHVS_BirthCountry_CDC

12. Country of Usual Residence

a. Country of Usual Residence: ___________________________________________________ [77983-5]

b. If NOT U.S. Reporting Area, Has Been in United States for ≥90 days (inclusive of Report Date)? [INV1114]

___ {N} No

Country Specify Options: Choose from value set PHVS_Country_ISO_3166-1

13. Initial Reason Evaluated for TB [INV1116] ___ {PHC681} Contact Investigation ___ {360156006} Screening

___ {PHC680} TB Symptoms

___ {OTH} Other

Risk Factors

14. Occupation and Industry

a. Has the patient ever worked as one of the following? (select all that apply) [INV1276]

___ {223366009} Healthcare Worker ___ {C0682244} Correctional Facility Employee ___ {PHC2121} Migrant/Seasonal Worker ___ {260413007} None of the above

b. Patient’s Current Occupation(s) and Industry(ies)

Occupation [85658-3]

Industry [85078-4]

Coded Occupation Options [85659-1]: If completing choose from value set PHVS_Occupation_CDC_Census2010

Coded Industry Options [85657-5]: If completing choose from value set PHVS_Industry_CDC_Census2010

15. Other Risk Factors

Risk Factor [INV1117] Indicator [INV1118]

{PHC2098} Diabetic at Diagnostic Evaluation {Y/N/UNK}

{PHC1876} Homeless in the Past 12 Months {Y/N/UNK}

{32911000} Homeless Ever {Y/N/UNK}

{257656006} Resident of Correctional Facility at Diagnostic Evaluation {Y/N/UNK}

{PHC2099} Resident of Correctional Facility Ever {Y/N/UNK}

{42665001} Resident of Long-Term Care Facility at Diagnostic Evaluation {Y/N/UNK}

{226034001} Injecting Drug Use in the Past 12 Months {Y/N/UNK}

{PHC1877} Noninjecting Drug Use in the Past 12 Months {Y/N/UNK}

{86933000} Heavy Alcohol Use in the Past 12 Months {Y/N/UNK}

{PHC690} TNF-α Antagonist Therapy {Y/N/UNK}

{161663000} Post-Organ Transplantation {Y/N/UNK}

{46177005} End Stage Renal Disease {Y/N/UNK}

{PHC2236} Viral Hepatitis (B or C only) {Y/N/UNK}

{PHC1878} Other Immunocompromise (other than HIV/AIDS) {Y/N/UNK}

{OTH} Other (Specify: ____________________________________) {Y/N/UNK}

16. If Resident of Correctional Facility at Diagnostic Evaluation, Type of Facility? [INV1119] ___ {PHC46} Federal Prison ___ {PHC26} State Prison ___ {PHC62} Local Jail ___ {C0680668} Juvenile Correction Facility ___ {OTH} Other Correctional Facility

17. If Resident of Long-Term Care Facility at Diagnostic Evaluation, Type of Facility? [INV1120] ___{C0028688} Nursing Home ___{PHC221} Hospital-Based Facility ___{C0035186} Residential Facility ___{283Q00000X} Mental Health Residential Facility ___{324500000X} Alcohol or Drug Treatment Facility ___{OTH} Other Long-Term Care Facility ___{UNK} Unknown

18. Current Smoking Status at Diagnostic Evaluation [72166-2]

___ {449868002} Current every day smoker ___ {428041000124106} Current someday smoker

___ {8517006} Former smoker

___ {266919005} Never smoker

___ {77176002} Smoker, current status unknown

___ {266927001} Unknown if ever smoked

19. Lived outside of the United States for >2 months (uninterrupted)? [INV1121] ___{Y} Yes ___{N} No ___{UNK} Unknown

Diagnostic Testing (Non-DST)

20. Tuberculin Skin Test and All Non-DST TB Laboratory Test Results Please provide a response for each of the main test types (culture, smear, pathology/cytology, NAA, TST, IGRA, HIV, diabetes) If test was not done please indicate so. See list example in table.

Test Type

[INV290]

Specimen Source Site [31208-2]

Date Collected/

Placed [68963-8]

Date Reported/

Read [82773-3]

Test Result (Qual.)

[INV291]

Test Result

(Quant.)

[LAB628]

Test Result (Units of Measure)

[LAB115]

TST Skin Structure // // Positive 15 mm

IGRA [spec. type] Blood // //

Test Type Options: {20431-3} Smear, {50595-8} Pathology, {10525-4} Cytology, {LAB673} NAA, {50941-4} Culture, {TB119} TST, {LAB671} IGRA-QFT, {LAB672} IGRA-TSpot, {71773-6} IGRA-Unknown, {LAB720} IGRA-Other, {55277-8} HIV, {24467-3} CD4 Count, {55454-3} Hemoglobin A1c, {76629-5} Fasting Blood Glucose, {LAB608} Other Test Type, and {LAB719} Pathology/Cytology

Specimen Source Options: Choose from value set PHVS_MicroscopicExamCultureSite_TB; examples: {39937001} Skin Structure, {87612001} Blood, {119334006} Sputum Test Result (Qualitative) Options: {10828004} Positive, {260385009} Negative, {82334004} Indeterminate, {385660001} Not Done, {UNK} Unknown, {443390004} Refused, {PHC2092} Test Done Result Unknown, {410530007} Not Offered Test Result (Units of Measure) Options: Choose from value set PHVS_UnitofMeasure_TB; examples: {mm} Millimeters of

Induration (TST), {{cells}/uL} Cell Count (CD4), {%} Percentage (HGB-A1c), {mg/dL} Milligrams per deciliter (FBG)

21. Chest Radiograph or Other Chest Imaging Study Results

(Please provide a response for each of the main test types (plain chest radiograph, chest CT Scan) and if test was not done please indicate so. See list example in table.)

Study Type

[LAB677]

Date of Study

[LAB681]

Result

[LAB678]

Cavity?

[LAB679]

Miliary?

[LAB680]

Plain Chest X-Ray //

CT Scan //

Study Type Options: {399208008} Plain Chest X-Ray, {169069000} CT Scan, {113091000} MRI, {82918005} PET, {OTH} Other

Result Options: {PHC1874} Not Consistent with TB, {PHC1873} Consistent with TB, {385660001} Not Done, {UNK} Unknown Cavity Options: {Y} Yes, {N} No, {UNK} Unknown Miliary Options: {Y} Yes, {N} No, {UNK} Unknown

Epidemiologic Investigation

22. Case Meets Binational Reporting Criteria? [INV1274] ___ {Y} Yes

If Yes, Which Criteria were Met? (Select All That Apply) [77988-4] ___ {PHC1140} Exposure to Suspected Product from Canada or Mexico (e.g., dairy product for M. bovis case)

___ {PHC1139} Has Case Contacts in or From Mexico or Canada ___ {PHC1215} Potentially Exposed by a Resident of Mexico or Canada ___ {PHC1137} Potentially Exposed while in Mexico or Canada ___ {PHC1138} Resident of Canada or Mexico ___ {PHC1141} Other Situations that May Require Binational Notification or Coordination of Response

23. Case Identified During the Contact Investigation Around Another Case? [INV1122]

If Yes, Evaluated for TB During that Contact Investigation? [INV1123] ___ {Y} Yes ___ {N} No ___ {UNK} Unknown

24. Complete Table Below for All Known TB and LTBI Cases Epidemiologically Linked to this Case (an unlimited number of rows may be entered):

State Case Number

[INV1124]

Treatment and Outcome Information

25. LTBI Therapy Started? [INV1128]

___ {Y} Yes (Treatment Start Date: //) [86948-7]

Specify Initial LTBI Regimen: [INV1129] ___ {PHC1882} Isoniazid (9 months; 9H) ___ {PHC1883} Isoniazid (6 months; 6H) ___ {PHC1884} Isoniazid/Rifapentine (3 months; 3HP) ___ {PHC1885} Rifampin (4 months; 4R) ___ {PHC2095} RIPE/HRZE (2 months) ___ {OTH} Other (Specify: ____________________________________________________________________)

___ {N} No

Why Not? [INV1130] ___ {399307001} Lost to follow-up ___ {PHC1886} History of previous treatment for TB or LTBI ___ {397745006} Treatment medically contraindicated ___ {183964008} Treatment not offered based on local clinic guidelines ___ {PHC2094} Provider decision (not based on local clinic guidelines) ___ {PHC1910} Drug shortage ___ {105480006} Patient refused ___ {OTH} Other (Specify: ____________________________________________________________________)

If Therapy Not Started or Unknown, STOP HERE.

If Therapy was Started, Continue to Question 26

26. Date Therapy Stopped: // [63939-3]

27. Treatment Administration (select all that apply) [55753-8]

___ {435891000124101} DOT (Directly Observed Therapy, in person) ___ {PHC1881} EDOT (Electronic DOT, via video call or other electronic method) ___ {225425006} Self-Administered

28. Reason LTBI Therapy Stopped? [INV1131]

___ {182992009} Completed Treatment ___ {399307001} Lost to Follow-up ___ {105480006} Patient Choice ___ {77386006} Pregnancy ___ {PHC1887} Not LTBI (Clinician Decision) ___ {OTH} Other (Specify: ___________) ___ {427099000} Developed TB (NTSS State Case Number:

- - ) [INV1132]

___ {24484000} Severe Adverse Event (select all that apply) [64750-3] ___ {434081000124108} Hospitalized ___ {399166001} Died

(PLEASE IMMEDIATELY REPORT ALL ADVERSE EVENTS RESULTING IN HOSPITALIZATION OR DEATH TO CDC AT

LTBIDRUGEVENTS@CDC.GOV)

END OF TBLISS Data Collection Form mailto:LTBIDRUGEVENTS@CDC.GOV