DRAFTPREDECISIONAL

Proposed Data Collection Form
TB Latent Infection Surveillance System (TBLISS) –Updated 2/22/2018

Administrative Information

  1. Date Reported: __/__/____ [77995-9]
  1. Date Counted[1]
  2. MMWR Week: ______[77991-8]
  3. MMWR Year: ______[77992-6]
  1. State Case Number: ______[INV1107]

YearStateNumber

  1. City/County Case Number:______[INV1108]

YearState Number

  1. Case Already Counted by Another Reporting Area?[2] [INV1109]

___Yes, another U.S. reporting area (State case number from other area: ______) [INV1110]

___Yes, another country (Specify country: ______) [INV1111]

___No

Demographics and Initial Evaluation

  1. Reporting Address
  2. City: ______[PID-11.3]
  1. Is the Patient’s Residence Within City Limits? [INV1112]

___Yes

___No

___Unknown

  1. County: ______[PID-11.9]
  1. ZIP Code: _____ - ____ [PID-11.5]
  1. Census Tract: ______[PID-11.10]
  1. Date of Birth: __/__/____ [PID-7]
  1. Sex at Birth [PID-8]

___Male

___Female

If Female, Was Patient Pregnant at Time of Diagnostic Evaluation? [77996-7]

___Yes

___No

___Unknown

___Unknown

  1. Ethnicity [PID-22]

___Hispanic or Latino

___Not Hispanic or Latino

___Other

___Unknown

  1. Race[PID-10]

___American Indian or Alaska Native

___Asian (Specify: ______) [DEM153]

___Black or African American

___Native Hawaiian or Other Pacific Islander (Specify: ______) [DEM153]

___White

___Other Race (Specify: ______) [32624-9]

___Unknown

  1. Nativity
  2. Country of Birth: ______[78746-5]

(If NOT United States, Date of First U.S. Arrival[3]: __/__/____) [DEM2005]

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

___Yes

___No

___Unknown

  1. Countries of Birth for Primary Guardian(s) (pediatric [<15 years old] cases only)
  2. Guardian 1: ______[INV1113]
  3. Guardian 2: ______[INV1113]
  1. U.S. Residency (for case counting purposes)
  2. Country of Usual Residence: ______[77983-5]
  1. If NOT U.S. Reporting Area, Remained in United States for ≥90 days after Report Date? [INV1114]

___Yes

___No

___Unknown

  1. Initial ReasonEvaluated for TB [INV1116]

___Contact Investigation

___Screening

___TB Symptoms

___Other

___Unknown

Diagnostic Testing (Non-DST)[4]

  1. Complete Table Below for Tuberculin Skin Test and All Non-DST TB Laboratory Test Results (an unlimited number of rows may be entered)[5]:

Date Collected/Placed / Date Reported/Read / Specimen
Source Site / Test
Type / Test Result (Qualitative) / Test Result (Quantitative) / Test Result
(Units of Measure)
[68963-8] / [82773-3] / [31208-2] / [INV290] / [INV291] / [LAB628] / [LAB115]

Specimen Source Site:Refer to anatomic code list

Test Type: Smear, Pathology, Cytology, NAA, Culture, TST, IGRA-QFT, IGRA-TSpot, IGRA-Unknown, HIV, CD4 Count, Hemoglobin A1c, Fasting Blood Glucose, Other (specify), etc.[6]

Test Result (Qualitative) Options: Positive, Negative, Indeterminate, Not Done, Unknown

Test Result (Quantitative) Options: Millimeters of Induration (TST), Cell Count (CD4), Percentage (HGB-A1c), Milligrams per deciliter (FBG), Other Units as Appropriate

  1. Chest Radiograph or Other Chest Imaging Study Results (an unlimited number of rows may be entered)

Date of Study / Study Type / Result / Cavity? / Miliary?
[LAB681] / [LAB677] / [LAB678] / [LAB679] / [LAB680]

Study Type: Plain Radiograph, CT Scan, MRI, PET, Other[7]

Result Options: Not Consistent with TB, Consistent with TB, Not Done, Unknown

Cavity?: Yes, No, Unknown

Miliary?: Yes, No, Unknown

Risk Factors

  1. Diabetes Status at Diagnostic Evaluation [33248-6]

___Diabetic

___Not Diabetic

___Unknown

  1. HIV Status at Diagnostic Evaluation [55277-8]

___Positive

___Negative

___Unknown

  1. Primary Occupation and Industry[8]
  2. Occupation
  3. Name: ______[85658-3]
  4. Code: ______[85659-1]
  5. Industry
  6. Name: ______[85078-4]
  7. Code: ______[85657-5]
  1. Additional Risk Factors

Risk Factor
[INV1117] / Yes/No/Unknown
[INV1118]
Homeless in the Past 12 Months
Homeless Ever
Resident of Correctional Facility at Diagnostic Evaluation
Resident of Long-Term Care Facility at Diagnostic Evaluation
Injecting Drug Use in the Past 12 Months
Noninjecting Drug Use in the Past 12 Months
Heavy Alcohol Use in the Past 12 Months
TNF-α Antagonist Therapy
Post-Organ Transplantation
End Stage Renal Disease
Other Immunocompromise (not HIV/AIDS)
Other (Specify: ______)
  1. If Resident of Correctional Facility at Diagnostic Evaluation, Type of Facility?[INV1119]

___Federal Prison

___State Prison

___Local Jail

___Juvenile Correction Facility

___Other Correctional Facility

___Unknown

  1. If Resident of Long-Term Care Facility at Diagnostic Evaluation, Type of Facility?[INV1120]

___Nursing Home

___Hospital-Based Facility

___Residential Facility

___Mental Health Residential Facility

___Alcohol or Drug Treatment Facility

___Other Long-Term Care Facility

___Unknown

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

___Current everyday smoker

___Current someday smoker

___Former smoker

___Never smoker

___Smoker, current status unknown

___Unknown if ever smoked

  1. Residence or Travel in Countries Other than the United States, Canada, Australia, New Zealand, or Countries in Northern or Western Europe for >60 consecutive days?[9][INV1121]

___Yes

___No

___Unknown

Epidemiologic Investigation

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

___Yes

If Yes, Evaluated for TB During that Contact Investigation?[INV1123]

___Yes

___No

___Unknown

___No

___Unknown

  1. 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 / Type of Link / Strength of Link / Directionality
[INV1124] / [INV1125] / [INV1126] / [INV1127]

Type of Link: Contact, Location, Other

Strength of Link: Definite, Probable, Possible[10]

Directionality: Source, Undetermined[11]

Treatment and Outcome Information

  1. LTBI Therapy Started? [INV1128]

___Yes (Treatment Start Date: __/__/____) [86948-7]

Specify Initial LTBI Regimen: [INV1129]

___Isoniazid (9 months; 9H)

___Isoniazid (6 months; 6H)

___Isoniazid/Rifapentine (3 months; 3HP)

___Rifampin (4 months; 4R)

___Other (Specify: ______)

___No

Why Not? [INV1130]

___Lost to follow-up

___History of previous treatment for TB or LTBI

___Treatment medically contraindicated

___Treatment not offered based on local clinic guidelines

___Patient refused

___Other (Specify: ______)

___Unknown

If Therapy Not Started or Unknown, STOP HERE.
If Therapy was Started, Continue to Question 27

  1. Date Therapy Stopped: __/__/____[63939-3]
  1. Treatment Administration (select all that apply) [55753-8]

___DOT (Directly Observed Therapy, in person)

___EDOT (Electronic DOT, via video call or other electronic method)

___Self-Administered

  1. Reason LTBI Therapy Stopped?[12][INV1131]

___Completed Treatment

___Lost to Follow-up

___Patient Choice

___Pregnancy

___Not LTBI (Clinician Decision)

___Other (Specify: ______)

___Developed TB (NTSS State Case Number: ______) [INV1132]

___Severe Adverse Event (select all that apply)

Hospitalized: Yes___No___ [64750-3]

Died: Yes___No___ [64750-3]

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

END OF TBLISS Data Collection Form

Endnotes

Page 1 of 7

[1] The MMWR Week and Year will facilitate data management and reporting by CSELS, and can be converted into the traditional “Count Date” as a calculation in the DTBE dataset.

[2] An affirmative answer to this question will result in the case report being classified as noncountable.

[3] This question will only be completed for patients who were born outside of the United States (regardless of whether they were “U.S.-born”). The date may be entered to the level of specificity known by the reporting area (e.g., year only, year and month, or full date).

[4] For all questions with relational tables to capture multiple results, reporting areas are asked to report at a minimum the initial result for each unique combination of test type and specimen type as well as the results of any tests that differ from a corresponding test done previously. For example, in an uncomplicated pulmonary TB case, reporting areas are asked to report the initial positive sputum result and the first negative sputum result. If sputum testing were to become subsequently positive again, reporting areas are asked to report that result as well. For reporting areas that want to include results other than the minimum as outlined above, the relational table will accept an unlimited number of results, but this is not required.

[5] Tests that can be reported in this table include (but are not limited to) smear, pathology, cytology, NAA, culture, TST, IGRA, HIV, and CD4 Count.

[6] Laboratory test types could be added to this table as new tests are developed.

[7] Additional imaging study types could be added to this table as new technology becomes available.

[8] Per CSTE position statement, surveillance systems for nationally notifiable diseases are beginning to collect data on the patient’s current primary occupation and industry. For parallel question structure, “current” has been interpreted on the RVCT as within the last year. The standard PHIN value set for occupation includes 544 “concepts” and the value set for industry includes 272 concepts. NIOSH provides an online coding engine (NIOCCS) that greatly simplifies the process of finding the most appropriate occupation and industry codes.

[9] Countries in Northern or Western Europe will be defined in the instruction manual.

[10] Definitions for the different categories of epidemiologic links will be included in the instruction manual.

[11] The directionality of the epidemiologic link is based on local investigative findings.

[12] The initial or immediate reason that therapy was stopped should be recorded here. For example, if the patient is experiencing adverse treatment events that eventually result in death, adverse treatment event should be recorded as the reason that therapy was stopped, and the patient’s eventual death would be recorded as the final case outcome. “Died” should only be selected if the patient was actively taking TB drugs at the time of death. “Dying” should be selected if the provider decided to discontinue TB drugs prior to death for reasons other than adverse treatment events, e.g., the patient is dying of cancer.