EPIDEMIOLOGY FOR CASE MANAGEMENT AND CONTACT …nid]/13...populations, and the application of this study to control health problems. ... 6,000 8,000 10,000 12,000: 1930 1935 1940 1945

TB CASE MANAGEMENT AND CONTACT INVESTIGATION INTENSIVE March 27-30, 2017

Curry International Tuberculosis Center, UCSF 300 Frank H. Ogawa Plaza, Suite 520 Oakland, CA; Office (510) 238-5100

EPIDEMIOLOGY FOR CASE MANAGEMENT AND CONTACT INVESTIGATION

LEARNING OBJECTIVES

Upon completion of this session, participants will be able to:

1. Define epidemiology

2. Describe basic epidemiology tools

3. Describe the use of program indicators to improve patient outcomes

4. Describe the use of genotyping data for targeted program interventions

INDEX OF MATERIALS PAGES

1. Epidemiology for Case Management and Contact Investigation – slide outline Presented by: Phil Lowenthal, MPH

1-13

SUPPLEMENTAL MATERIALS

1. CDC Trends in tuberculosis—United States, 2016. MMWR March 25, 2016

2. State of California Tuberculosis Indicators At A Glance. 2015.

3. Report of Verified Case of Tuberculosis (RVCT), Follow-up 1, and Follow-up 2 Forms

4. Aggregate Reports for Tuberculosis Program Evaluation (ARPE)

TB CASE MANAGEMENT AND CONTACT INVESTIGATION INTENSIVE March 27-30, 2017

Curry International Tuberculosis Center, UCSF 300 Frank H. Ogawa Plaza, Suite 520 Oakland, CA; Office (510) 238-5100

ADDITIONAL REFERENCES

• Centers for Disease Control and Prevention: Reported Tuberculosis in the United States, 2015.

https://www.cdc.gov/tb/statistics/reports/2015/pdfs/2015_surveillance_report_fullreport.pdf

• Ehman M, Shaw T, Cass A, et al. Developing and Using Performance Measures Based on Surveillance Data for Program Improvement in Tuberculosis Control. J Public Health Management Practice. 2013, 19(5), E29-E37.

• Ong A, Rudoy I, Gonzalez LC, et al. Tuberculosis in healthcare workers: a molecular

epidemiologic study in San Francisco. Infect Control Hosp Epidemiol. May 2006; 27(5):453-8.

• Sprinson JE, Lawton ES, Porco TC, et al. Assessing the validity of tuberculosis surveillance data in California. BMC Public Health. Aug 2006; 6:217.

• Controlling Tuberculosis in the United States: Recommendations from the American Thoracic

Society, CDC, and the Infectious Diseases Society of America. MMWR. November 4, 2005; 54 (RR12);1-81. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5412a1.htm

• National TB Controllers Association/CDC Advisory Group on Tuberculosis Genotyping. Guide to the Application of Genotyping to Tuberculosis Prevention and Control. Atlanta, GA: US Department of Health and Human Services, CDC; June 2004. http://www.cdc.gov/tb/programs/genotyping/images/TBGenotypingGuide_June2004.pdf

• Geiter LJ. Ending neglect: the elimination of tuberculosis in the United States. Washington D.C.: National Academy Press; 2000.

https://www.cdc.gov/tb/statistics/reports/2015/pdfs/2015_surveillance_report_fullreport.pdf

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5412a1.htm

http://www.cdc.gov/tb/programs/genotyping/images/TBGenotypingGuide_June2004.pdf

Epidemiology for Case Management and Contact Investigation1

TB Case Management and Contact Investigation IntensiveMarch 27-30, 2017Curry International Tuberculosis Center

Epidemiology for Case Management and

Contact InvestigationPhil Lowenthal, MPH

Epidemiologist

California Department of Public HealthTB Control Branch

CMCI Course – March 29th 2017

Curry Center

ObjectivesUpon completion of this session participants will be able to:

Describe basic epidemiology tools Describe the use of program indicators to improve patient outcomes

Describe the use of genotyping data for targeted program interventions

Define epidemiology



The study of the distribution and determinants of health‐related states or events in specified populations, and the application of this study to control health problems.

Last. A Dictionary of Epidemiology, 1995

What is Epidemiology?

Put simply…

“Epidemiology is the study of disease and disease characteristics in a population over time.”

Sources of information – what data is available to you?

Surveillance Data: RVCT (CalREDIE), ARPE (CI)Patient Data: Chart, electronic medical recordLaboratory Data: Genotyping, pyrosequencingLocal Demographics: Estimates of homeless, immigration, etc. Census Data: Population count by demographics

Epi Tools



Proportion/percentCalifornia TB patients with diabetes (2016): 0.27 (proportion) or 27% (percent)

Epi Tools (2)Basic calculations – how to translate patient data into epi data

Percent change over time[(Count at t2 – Count at t1)/Count at t1] x 1002016=2,073 cases, 2015=2,131 cases[(2,073‐2,131)/2,131] x 100 = ‐0.027 or ‐2.7% decrease

Rate per 100,000 population(CA cases in 2016 / CA population in 2016) x 100,000(2,073/39.4 million) x 100,000 = 5.3 TB cases per 100,000 pop

Incidence vs. prevalence – important to distinguish between disease frequency and disease burden

Incidence: Number of new cases during a given time period

Prevalence: Total number of new and existing cases during a given time period

Epi Tools (3)



Tuberculosis Cases and Case Rates California, 1930–2016

0

20

40

60

80

100

120

140

160

180

200

0

2,000

4,000

6,000

8,000

10,000

12,000

1930

1935

1940

1945

1950

1955

1960

1965

1970

1975

1980

1985

1990

1995

2000

2005

2010

2015

Number of TB

Cases

TB Cases TB Rate

Case Rate per 100,000

Using Program Indicators



Reflect the program/state/national priorities for TB control and prevention activities

Program Indicators

Provide a monitoring system for tracking progress at the program level over time

Utilize data already collected by the program for surveillance and case management/contact investigation activities

Use standardized methods for calculating measures so tracking is consistent across sites (i.e. comparisons between states) and over time

Case Management Indicators

Indicator Year CA data

Change from previousyear

NTIP*target (2020)

Timely case reporting 2015 89% 1% () N/A

Timely treatment initiation 2015 91% No change 97%

Initiation of a four‐drug regimen

2015 93% 1% () 97%

Inappropriate use of SAT 2013 9% No change N/A

Treatment completion within 12 months

2013 88% 1% () 95%

Sputum culture conversion 2013 70% No change 73%

Known HIV status 2015 89% 1% () 98%

*NTIP: National TB Indicators Project



Indicator: Percent of TB patients with positive sputum culture results who have documented conversion to sputum culture‐negative within 60 days of treatment initiation

Data Sources: RVCT fields: Month‐Year Counted, Status at Diagnosis of TB, Sputum Culture, Date Therapy Started, Date Therapy Stopped, Reason Therapy Stopped, Sputum Culture Conversion Documented.

Cohort: TB patients with positive sputum culture results alive at diagnosis and have initiated treatment, counted in the year of interest. Patients who died within 60 days of initiating treatment are excluded.

Sputum Culture Conversion

Calculation:[Number of TB patients with positive sputum culture results who have documented conversion to sputum culture‐negative within 60 days of treatment initiation] / Cohort

Sputum Culture Conversion (2)

X 100








Next Steps:Identify areas were improvements can be made

6% of cases don’t have conversion documented – Why?

Delayed conversions for 138 (22%) of culture‐positive cases – Why?

Delayed collection of sputum?

Inadequate treatment regimen or drug resistance?

Laboratory delays in reporting results? What patterns do you see over time?

Using Genotyping Data

1) Brief overview of genotyping program in California

2) Example of genotype cluster surveillance



Goal: Genotype all culture‐confirmed TB cases in the U.S.

1 lab contracted by the CDC: Michigan state lab Genotype results provided to LHDs via secure online database (TB GIMS)

High percentage of CA culture confirmed TB cases genotyped in 2016 (92%) (Goal (2020): 100%)

National TB Genotyping Service

Run algorithm to detect: Growing clusters within a short period of time

Clusters localized within a county New clusters

Review clusters with high LLR score High LLR = unexpected geospatial concentration

Assess and prioritize flagged clusters using surveillance data

Notify LHDs of concerning clusters

Surveillance methods



Are there any links among these cases that could suggest recent transmission?

Example of a Concerning TB Genotype Cluster

Case #

Report date

CountyCountry Birth

Major Site

Sputum Smear

Sputum Culture

CavitaryRVCT Risk

FactorsDST

4 Oct 2010 A Vietnam Pleural Neg Neg NoImmSupp

S

3 Oct 2010 A Vietnam Pulm Pos Pos Yes S

2 Sep 2010 A Mexico Pulm Pos Pos No S

1 Apr 2008 A Vietnam Pulm Pos Pos No Alcohol S

Initial review by the local health department

2 brothers in household No known epi links to the other 2

clustered cases Important worksites: Casino, restaurant Potential next steps: More chart review, patient re‐interviews Teleconference with case managers



Genotyping helped with outbreak case finding:

Identified outbreak cases and transmission sites not detected by traditional epidemiologic investigations

Congregate investigations were expanded and a screening program in the outpatient clinic will be implemented

Summary

The LHD will aggressively pursue contact evaluation and treatment for latent TB infection LHD will f/u with contacts in next 2 years LHD will routinely review data of contacts

associated with this outbreak at case conferences

Monitor for new cases with the same genotype

Next Steps



CDC Surveillance Reportshttp://www.cdc.gov/tb/statistics/default.htm

Program Evaluation and NTIPhttp://www.cdc.gov/tb/programs/Evaluation/Default.htm

Genotyping http://www.cdc.gov/tb/programs/genotyping/default.htm

TB Outbreak Response Team Fact Sheethttp://www.cdph.ca.gov/programs/tb/Documents/TBCB‐ORT‐Fact‐Sheet.pdf

U.S. Census Bureauhttp://www.census.gov

World Health Organization – Global TB Reporthttp://www.who.int/tb/publications/global_report/en/index.html

Mapping Americahttp://projects.nytimes.com/census/2010/explorer?view=raceethnicit &lat=37.75&lng=‐122.45&l=12

Additional Resources

Mapping America



0

20

40

60

80

1002006

2007

2008

2009

2010

2011

2012

2013

2014

2015

Percent

China India Mexico Philippines Vietnam

Percent of Cases by Time in US and Country of Origin, California, 2006‐2015

< 1 year in US

5+ years in US0

20

40

60

80

100

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

Thank you

Questions?

Leveling of Tuberculosis Incidence — United States, 2013–2015

Jorge L. Salinas, MD1,2; Godwin Mindra, MBChB1,2; Maryam B. Haddad, MSN2; Robert Pratt2; Sandy F. Price2; Adam J. Langer, DVM2

After 2 decades of progress toward tuberculosis (TB) elimina-tion with annual decreases of ≥0.2 cases per 100,000 persons (1), TB incidence in the United States remained approximately 3.0 cases per 100,000 persons during 2013–2015. Preliminary data reported to the National Tuberculosis Surveillance System indicate that TB incidence among foreign-born persons in the United States (15.1 cases per 100,000) has remained approximately 13 times the incidence among U.S.-born per-sons (1.2 cases per 100,000). Resuming progress toward TB elimination in the United States will require intensification of efforts both in the United States and globally, including increasing U.S. efforts to detect and treat latent TB infection,

Continuing Education examination available at http://www.cdc.gov/mmwr/cme/conted_info.html#weekly.

U.S. Department of Health and Human ServicesCenters for Disease Control and Prevention

Morbidity and Mortality Weekly ReportWeekly / Vol. 65 / No. 11 March 25, 2016

INSIDE279 Tuberculosis Among Temporary Visa Holders

Working in the Tourism Industry — United States, 2012–2014

282 Photokeratitis Linked to Metal Halide Bulbs in Two Gymnasiums — Philadelphia, Pennsylvania, 2011 and 2013

286 Travel-Associated Zika Virus Disease Cases Among U.S. Residents — United States, January 2015–February 2016

290 Preventing Transmission of Zika Virus in Labor and Delivery Settings Through Implementation of Standard Precautions — United States, 2016

293 Notes from the Field: Injuries Associated with Bison Encounters — Yellowstone National Park, 2015

296 QuickStats

World TB Day — March 24, 2016

World TB Day is recognized each year on March 24, which commemorates the date in 1882 when Dr. Robert Koch announced his discovery of Mycobacterium tuberculosis, the bacillus that causes tuberculosis (TB). World TB Day is an opportunity to raise awareness about TB and support worldwide TB prevention and control efforts. The U.S. theme for World TB Day, “Unite to End TB,” highlights how much more needs to be done to eliminate TB in the United States.

After 2 decades of annual declines, TB incidence in the United States has leveled at approximately 3.0 new cases per 100,000 persons. (1,2). The determinants of this leveling in TB incidence are not yet clear; further evaluation of available data is required to understand the causes of this trend.

CDC is committed to eliminating TB in the United States. Staying on the path toward TB elimination will require more intensive efforts, both in the United States and globally. These efforts will not only focus on strengthening existing systems for interrupting TB transmission, but also on increasing testing and treat-ment of persons with latent TB infection. Additional information about World TB Day and CDC’s TB elimination activities is available on CDC’s website (http://www.cdc.gov/tb/worldtbday).

References

1. Salinas JL, Mindra G, Haddad MB, Pratt R, Price SF, Langer AJ. Leveling of tuberculosis incidence—United States, 2013–2015. MMWR Morb Mortal Wkly Rep 2016;65:273–8.

2. CDC. Reported tuberculosis in the United States, 2014. Atlanta, GA: US Department of Health and Human Services, CDC; 2015.

http://www.cdc.gov/mmwr/cme/conted_info.html#weekly

http://www.cdc.gov/tb/worldtbday

CDC 2015

OBJECTIVES°YEAR*

CALIFORNIA

DATA

NUMBER OF

CASES OR

CONTACTS

NOT MEETING

INDICATOR

CA 2010

OBJECTIVES**

CA 2015

OBJECTIVES**

GOAL B: Ensure early identification and reporting of all persons with tuberculosis.

B1: TB Case Rate 2015 5.5 2137

B2: Timely Reporting 2015

B3: Complete Reporting 2015 KEY VARIABLES

Homelessness:

IDU:

Non IDU:

Alcohol:

48

B4: Culture Identification 2015

100%

99%

99%

99%

92%

89%

C1: Recommended Initial Therapy

GOAL C: Ensure timely completion of therapy for all persons with tuberculosis.

94%

C2: Timely Treatment

2015

2015

C3: Culture Conversion 70%

C4-A: Appropriate DOT^

C4-B: Inappropriate SAT^

C5: Timely Completion of Therapy

C6: Not Defaulting from Treatment

* The cohort year used to calculate data in the following columns.

** State objectives from "California Objectives for TB Indicators," October 2008, at www.cdph.ca.gov/programs/tb/pages/tuberculosisindicatorsproject.aspx.

° National objectives from "National TB Program Objectives and Performance Targets for 2015," January 2009, at www.cdc.gov/tb.

^ Per CDPH and HIV/MMWR guidelines, persons with the following factors measured by the RVCT are prioritized for DOT: children, adolescents, history of TB, homelessness, alcohol use,

injecting/non-injecting drug use, diagnosis in a correctional facility, sputum smear-positive. Two factors for prioritized DOT that may be identified after treatment start are: resistance to isoniazid or

rifampin, slow to culture convert (>2 months).

225

139

84

352

65

247

5%

57%

87%

98%

6.0 3.9 N/A

90% 93%

>99% N/A

96% 98%

N/A

96%

93% 95% 93%

91% 95% N/A

67% 71% 62%

77% 89% N/A

N/A<1%5%

83% 88% 93%

N/A98% 99%

INDICATOR

STATE OF CALIFORNIA

Indicators at a Glance

2012

2012

2012

2012

2012

91%

268

34

99%

127

Indicators at a Glance - Page 1 of 2 Print Date: 2/17/2016 Data Files Used: CI 2013 Final, prvctye15 (99.6% complete CA)

INDICATOR YEAR

CALIFORNIA

DATA

NUMBER OF

CASES OR

CONTACTS

NOT MEETING

INDICATOR

CA 2010

OBJECTIVES

CA 2015

OBJECTIVES

CDC 2015

OBJECTIVES

GOAL D: Ensure contacts to a person with infectious TB are promptly identified, examined, and if appropriate, complete treatment for latent TB infections.

D1: Contact Identification

D2: Contact Evaluation

D3: Contact Treatment Initiation

D4: Contact Treatment Completion

93% 67

87% 1692

64% 1181

62% 809

1.7% 2015SE1: Pediatric TB Cases

SE2: TB Deaths

GOAL E: Reduce the occurrence of sentinel events.

95% >99% 100%

89% 96% 93%

72%

78% N/A

2.5%

89% N/A

7.2%

1.3% N/A

4.8% N/A

STATE OF CALIFORNIA

Indicators at a Glance

65%

2013

2013

2013

2013

2012 168

Dead At Diagnosis

Deaths During Therapy

36

You are welcome to adapt the indicator reports for your program's use. If you do, please credit the California Department of Public Health, Tuberculosis Control Branch.

You are welcome to also include the Web address (URL) (http://tbdata.ca.gov) for the indicator reports in your credits.

Example credit: From [or adapted from] materials created for the Tuberculosis Indicators Project, by the California Department of Public Health, Tuberculosis Control Branch.

Example citation: California Department of Public Health, Tuberculosis Control Branch. Tuberculosis Indicators Project Indicator Reports [or, Indicator Report C4-A]. August 2009.

20129.7%

44

Indicators at a Glance - Page 2 of 2 Data Files Used: CI 2013 Final, prvctye15 (99.6% complete CA)Print Date: 2/17/2016

State of California—Health and Human Services Agency California Department of Public Health

Street Address

Patient’s Name (Last) (First) (M.I.)

REPORT OF VERIFIED CASE OF TUBERCULOSIS

(ZIP CODE)

State CodeYear Reported (YYYY) Locally Assigned Identification Number


1. Date Reported 3. Case Numbers

State Case Number

City/County Case Number

Linking State Case Number

Linking State Case Number

2. Date Submitted

Month Day Year

Month Day Year

Reason:

4. Reporting Address for Case Counting

City

Within City Limits (select one) Yes No

8. Date of Birth

Month Day Year

County 9. Sex at Birth (select one)

Male Female

11. Race (select one or more) American Indian or Alaska Native

White

Black or African American

Asian: Specify

Native Hawaiian or Other Pacific Islander: Specify

ZIP CODE 10. Ethnicity (select one)

Not Hispanic or Latino

Hispanic or Latino5. Count Status (select one)

Countable TB Case

Noncountable TB Case

Count as a TB case in your jurisdiction

Verified Case: Counted by another U.S. area (state)

Verified Case: Recurrent TB within 12 months after completion of therapy

Verified Case: TB treatment initiated in another country Specify

6. Date Counted Month Day Year

7. Previous Diagnosis of TB Disease (select one)

If YES, enter year of previous TB disease diagnosis:

Yes No

12. Country of Birth “U.S.-born” (or born abroad to a parent who was a U.S. citizen) (select one) Yes No

Country of birth: Specify

13. Month-Year Arrived in U.S. Year Month

14. Pediatric TB Patients (<15 years old) 16. Site of TB Disease (select all that apply)

15. Status at TB Diagnosis (select one)

Month Day Year

Country of Birth for Primary Guardian(s): Specify

Patient lived outside U.S. for >2 months? (select one)

If DEAD, enter date of death:

If DEAD, was death related to TB disease? (select one)

Bone and/or Joint

Genitourinary

Meningeal

Peritoneal

Other: Enter anatomic code(s) (see list):

Site not stated

Pulmonary

Pleural

Lymphatic: Cervical

Lymphatic: Intrathoracic

Lymphatic: Axillary

Lymphatic: Other

Lymphatic: Unknown

Laryngeal

Yes No Unknown

Yes No Unknown

Alive Dead

1

2

3

{

Guardian 1

Guardian 2

If YES, list countries, specify:

Public reporting burden of this collection of information is estimated to average 35 minutes 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, Project Clearance Officer, 1600 Clifton Road, MS D-74, Atlanta, CA 30333, ATTN: PRA (0920-0026). Do not send the completed form to this address.

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 only 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).

CDPH 8620A (1/3) Rev. 12/09 OSP 09 117029 REPORT OF VERIFIED CASE OF TUBERCULOSIS Page 1 of 3

Patient’s Name State Case No. REPORT OF VERIFIED CASE (Last) (First) (M.I.) OF TUBERCULOSIS


23. Tuberculin (Mantoux) Skin Test at Diagnosis (select one)

25. Primary Reason Evaluated for TB Disease (select one)

24. Interferon Gamma Release Assay for Mycobacterium tuberculosis at Diagnosis (select one)

17. Sputum Smear (select one)

18. Sputum Culture (select one)

19. Smear/Pathology/Cytology of Tissue and Other Body Fluids (select one)

20. Culture of Tissue and Other Body Fluids (select one)

21. Nucleic Acid Amplification Test Result (select one)

Initial Chest Radiograph and Other Chest Imaging Study

22A. Initial Chest Radiograph (select one)

22B. Initial Chest CT Scan or Other Chest Imaging Study (select one)

Date Collected:

Month Day Year

Date Collected:

Month Day Year

Date Collected:

Month Day Year

Date Collected:

Normal

Normal

Abnormal* (consistent with TB)

Abnormal* (consistent with TB)

* For ABNORMAL Initial Chest Radiograph:

* For ABNORMAL Initial Chest Radiograph: Evidence of a cavity (select one):

Date Tuberculin Skin Test (TST) Placed: Millimeters (mm) of induration:

Evidence of miliary TB (select one):

Evidence of a cavity (select one):

Evidence of miliary TB (select one):

Month Day Year

Date Collected: Month Day Year

Month Day Year

Enter anatomic code (see list):

Enter anatomic code (see list):

Enter specimen type: OR If not Sputum, enter anatomic code (see list):

Month Day Year

Date Collected:

Date Result Reported:

Month Day Year

Date Result Reported:

Month Day Year

Date Result Reported: Month Day Year

TB Symptoms

Abnormal Chest Radiograph (consistent with TB)

Contact Investigation

Targeted Testing

Health Care Worker

Employment/Administrative Testing

Immigration Medical Exam

Incidental Lab Result

Unknown

Reporting Laboratory Type (select one): Public Health Laboratory

Commercial Laboratory Other

Reporting Laboratory Type (select one): Public Health Laboratory


Type of exam (select all that apply):

Smear Pathology/Cytology

Reporting Laboratory Type (select one):

Public Health Laboratory


Positive

Negative

Not Done

Unknown

Positive

Negative

Not Done

Unknown

Positive

Negative

Not Done

Unknown

Positive

Negative

Not Done

Unknown

Positive

Negative

Not Done

Sputum

Unknown

Indeterminate

Not DonePositive

Not Done

Not Done

Unknown Negative

Unknown

Unknown

Positive

Negative

Indeterminate

Not Done

Unknown

Yes No

Yes No Unknown

Yes No Unknown

Yes No Unknown

Unknown

Test type:

Specify

CDPH 8620A (2/3) Rev. 12/09 REPORT OF VERIFIED CASE OF TUBERCULOSIS Page 2 of 3

Patient’s Name State Case No. REPORT OF VERIFIED CASE (Last) (First) (M.I.) OF TUBERCULOSIS


Positive Refused

Negative Indeterminate

Federal Prison

If YES, (select one)

If YES, (select one)

State Prison

Local Jail

Juvenile Correction Facility

Alcohol or Drug Treatment Facility

Other Long-Term Care Facility

Not Seeking Employment (e.g. student, homemaker, disabled person)

Unknown

Migrant/Seasonal Worker

Other OccupationCorrectional Facility Employee

Contact of Infectious TB Patient (2 years or less)

Post-organ Transplantation

Isoniazid

No Yes Unk No Yes Unk No Yes Unk

Rifampin

Moxifloxacin

Cycloserine

Para-Amino Salicylic Acid

Ethionamide

Other

Other

Specify

Specify

Amikacin

Kanamycin

Capreomycin

Ciprofloxacin

Levofloxacin

Ofloxacin Rifapentine

Rifabutin

Streptomycin

Ethambutol

Pyrazinamide

Contact of MDR-TB Patient (2 years or less) Incomplete LTBI Therapy Other Specify

None

Missed Contact (2 years or less)

Diabetes Mellitus

End-Stage Renal Disease

Not Applicable s� h5�3� �BORNv��OR�BORN�ABROAD�TO�A�PARENT�WHO�WAS�A�5��3��CITIZEN s� "ORN�IN��OF�THE�5�3��4ERRITORIES��5�3��)SLAND�!REAS��OR�5�3��/UTLYING�!REAS��

35CA. If arrived in the US within the last 12 months, did patient arrive with a TB A/B-notification?

If Yes, enter Alien Number:

Family/Fiancé Visa

Immigrant Visa

Student Visa

Employment Visa Unknown

Other Immigration Status

Asylee or Parolee Tourist Visa

Refugee

Immunosuppression (not HIV/AIDS)

TNF Antagonist Therapy

Unemployed

Retired

Hospital -Based Facility

Health Care Worker

Nursing Home Residential Facility

Mental Health Residential Facility

Test Done, Results Unknown

Unknown Not Offered

26. HIV Status at Time of Diagnosis (select one)

34. Additional TB Risk Factors (select all that apply)

35. Immigration Status at First Entry to the U.S. (select one)

36. Date Therapy Started

Comments:

37. Initial Drug Regimen (select one option for each drug)

33. Excess Alcohol Use Within Past Year

29. Resident of Long-Term Care Facility at Time of Diagnosis (select one)

30. Primary Occupation Within the Past Year (select one)

31. Injecting Drug Use Within Past Year 32. Non-Injecting Drug Use Within Past Year

28. Resident of Correctional Facility at Time of Diagnosis (select one)27. Homeless Within Past Year

(select one) (select one) (select one)

(select one)

Month Day Year

Unknown

No

Unknown

If YES, under custody of Immigration and Customs Enforcement? (select one)

State HIV/AIDS Patient Number:

If POSITIVE, enter:

City/County HIV/AIDS Patient Number:

Other Correctional Facility

Unknown

Yes No

Unknown Yes

Unknown Yes No Unknown Yes No Unknown Yes No

Yes No

Unknown Yes No

Unknown Yes No(select one)

B�

CDPH 8620A (3/3) Rev. 12/09 REPORT OF VERIFIED CASE OF TUBERCULOSIS Page 3 of 3


Street Address

Patient’s Name (Last) (First) (M.I.)

(Number, Street, City, State) (ZIP CODE)



Initial Drug Susceptibility Report (Follow Up Report – 1)

State Case Number

City/County Case Number

Year Counted

Submit this report for all culture-positive cases.

38. Genotyping Accession Number

Isolate submitted for genotyping (select one):

Was drug susceptibility testing done? (select one)

If YES, enter date FIRST isolate collected for which drug susceptibility testing was done:

Enter specimen type:

Isoniazid Capreomycin

Ciprofloxacin

Levofloxacin

Ofloxacin

Moxifloxacin

Other Quinolones

Cycloserine


Other

Other

Specify

Specify

Rifampin

Pyrazinamide

Ethambutol

Streptomycin

Rifabutin

Rifapentine

Ethionamide

Amikacin

Kanamycin

If NO or UNKNOWN, do not complete the rest of Follow Up Report – 1

If YES, enter genotyping accession number for episode:

39. Initial Drug Susceptibility Testing

40. Initial Drug Susceptibility Results (select one option for each drug)

Comments:

Month Day Year

No Yes Unknown

No Yes

Sputum

OR

If not Sputum, enter anatomic code (see list):

Resistant Susceptible Not Done Unknown Resistant Susceptible Not Done Unknown

Public reporting burden of this collection of information is estimated to average 35 minutes 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, Project Clearance Officer, 1600 Clifton Road, MS D-74, Atlanta, CA 30333, ATTN: PRA (0920-0026). Do not send the completed form to this address.

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 only 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).

OSP 09 117028 REPORT OF VERIFIED CASE OF TUBERCULOSIS Follow Up Report -1 / Page 1 of 1 CDPH 8620B (1/1) Rev. 12/09

REPORT OF VERIFIED CASEOF TUBERCULOSIS

Street Address

Patient’s Name(Last) (First)

(Number, Street, City, State)

(M.I.)

(ZIP CODE)


REPORT OF VERIFIED CASE OF TUBERCULOSIS Follow Up Report - 2 / Page 1 of 2

Public reporting burden of this collection of information is estimated to average 35 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and main-taining 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 itdisplays 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,

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 only 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).

41. Sputum Culture Conversion Documented (select one)

Did the patient move before starting or during TB therapy?

If YES, moved to where (select all that apply)

If moved out of the U.S., transnational referral? (select one)

(select one)

If YES, enter date specimen collected for FIRSTconsistently negative sputum culture:

If NO, enter reason for not documenting sputum culture conversion (select one):

42. Moved

43. Date Therapy Stopped

45. Reason Therapy Extended >12 months (select all that apply)

46. Type of Outpatient Health Care Provider (select all that apply)

44. Reason Therapy Stopped or Never Started (select one)

Comments:

StateCase Number

City/CountyCase Number

Year Counted

Month Day Year

Month Day Year

Rifampin Resistance

Local/State Health Department (HD)

Non-adherence

IHS, Tribal HD, or Tribal Corporation Inpatient Care Only Unknown

Clinically Indicated - other reasons

Adverse Drug Reaction

Private Outpatient

Failure

Institutional/Correctional Other

Other Specify

No Follow-upSputum Despite Induction

No Follow-up Sputum and No Induction

Completed Therapy If DIED, indicate cause of death (select one):Not TB

Died Related to TB disease

Related to TB therapy

Unrelated to TB disease

UnknownOther

Unknown

Lost

Uncooperative or Refused

Adverse Treatment Event

Unknown

Patient Refused Patient Lost to Follow-Up

Died

In state, out of jurisdiction (enter city/county):

Out of state (enter state)

Out of the U.S. (enter country)

No Yes Unknown

No Yes

No Yes

Case Completion Report

Submit this report for all cases in which the patient was alive at diagnosis.

(Follow Up Report – 2)

Specify Date Patient Received








Other Specify


OSP 09 117030

Project Clearance Officer, 1600 Clifton Road, MS D-74, Atlanta, CA 30333, ATTN: PRA (0920-0026). Do not send the completed form to this address.

CDPH 8620C (1/2) Rev. 12/09

REPORT OF VERIFIED CASEOF TUBERCULOSISPatient’s Name

(Last) (First) (M.I.)


REPORT OF VERIFIED CASE OF TUBERCULOSIS Follow Up Report -2 / Page 2 of 2

Public reporting burden of this collection of information is estimated to average 35 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and main-taining 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 itdisplays 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,

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 only 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).

47. Directly Observed Therapy (DOT) (select one)

No, Totally Self-Administered

Yes, Totally Directly Observed

Yes, Both Directly Observed and Self-Administered

Unknown

Was follow-up drug susceptibility testing done? (select one)

If YES, enter date FINAL isolate collected for which drug susceptibilitytesting was done:

Enter specimen type:

Isoniazid Capreomycin

Ciprofloxacin

Levofloxacin

Ofloxacin

Moxifloxacin

Other Quinolones

Cycloserine


Other

Other

Specify

Specify

Rifampin

Pyrazinamide

Ethambutol

Streptomycin

Rifabutin

Rifapentine

Ethionamide

Amikacin

Kanamycin

If NO or UNKNOWN, do not complete the rest of Follow Up Report – 2

Number of weeks of directly observed therapy (DOT)

48. Final Drug Susceptibility Testing

49. Final Drug Susceptibility Results (select one option for each drug)

Comments:

Month Day Year

No Yes Unknown

Sputum

OR

If not Sputum, enter anatomic code (see list):

Case Completion Report - Continued (Follow Up Report – 2)

Resistant Susceptible Not Done Unknown Resistant Susceptible Not Done Unknown

State Case No.


OSP 09 117030

Project Clearance Officer, 1600 Clifton Road, MS D-74, Atlanta, CA 30333, ATTN: PRA (0920-0026). Do not send the completed form to this address.

CDPH 8620C (2/2) Rev. 12/09


CDPH 8635 A (9/07; Revised 12/11) Page 1 of 8

Aggregate Reports for Tuberculosis Program Evaluation: Follow-up and Treatment for Contacts to Tuberculosis Cases

Preliminary Report Reporting Area: Submitted By: Cohort:

Telephone:

E-mail:

Total TB Cases Reported: Date Submitted:

Part I. Cases and Contacts Types of Cases for Investigation:

Sputum smear (+) Sp. smear (–), cult. or NAAT (+) Other Pulmonary

Cases for Investigation .............................. (a1) (a2) (a)

Cases with No Contacts ....................... (b1) (b2) (b)

Number of Contacts .................................. (c1) (c2) (c)

Evaluated .................................................. (d1) (d2) (d)

TB Disease ................................................ (e1) (e2) (e)

Latent TB Infection .................................... (f1) (f2) (f)

Started Treatment ................................ (g1) (g2) (g)

Completed Treatment ...........................

Reasons Treatment Not Completed: Death .........................................................

Contact Moved (follow-up unknown) .........

Active TB Developed .................................

Adverse Effect of Medicine ........................

Contact Chose to Stop ..............................

Contact is Lost to Follow-up ......................

Provider Decision ......................................

Still on Treatment ......................................

Part II. Evaluation Indices No-Contacts Rate ...................................... (b1 ÷ a1), % (b2 ÷ a2), % (b ÷ a), %

Contacts Per Case .................................... (c1 ÷ a1) (c2 ÷ a2) (c ÷ a)

Evaluation Rate ......................................... (d1 ÷ c1), % (d2 ÷ c2), % (d ÷ c), %

Disease Rate ............................................. (e1 ÷ d1), % (e2 ÷ d2), % (e ÷ d), %

Latent Infection Rate ................................. (f1 ÷ d1), % (f2 ÷ d2), % (f ÷ d), %

Treatment Rate ......................................... (g1 ÷ f1), % (g2 ÷ f2), % (g ÷ f), %

Completion Rate ....................................... (h1 ÷ g1), % (h2 ÷ g2), % (h ÷ g), %


CDPH 8635 B (9/07; Revised 12/11) Page 2 of 8

Aggregate Reports for Tuberculosis Program Evaluation: Follow-up and Treatment for Contacts to Tuberculosis Cases

Final Report Reporting Area: Submitted By:

Cohort:

Telephone:

E-mail:

Total TB Cases Reported: Date Submitted:

Part I. Cases and Contacts Types of Cases for Investigation:

Sputum smear (+) Sp. smear (–), cult. or NAAT (+) Other Pulmonary

Cases for Investigation .............................. (a1) (a2) (a)

Cases with No Contacts ....................... (b1) (b2) (b)

Number of Contacts .................................. (c1) (c2) (c)

Evaluated .................................................. (d1) (d2) (d)

TB Disease ................................................ (e1) (e2) (e)

Latent TB Infection .................................... (f1) (f2) (f)

Started Treatment ................................ (g1) (g2) (g)

Completed Treatment ........................... (h1) (h2) (h)

Reasons Treatment Not Completed:

Death .........................................................

Contact Moved (follow-up unknown) .........

Active TB Developed .................................

Adverse Effect of Medicine ........................

Contact Chose to Stop ..............................

Contact is Lost to Follow-up ......................

Provider Decision ......................................

Still on Treatment ......................................

Part II. Evaluation Indices

No-Contacts Rate ...................................... (b1 ÷ a1), % (b2 ÷ a2), % (b ÷ a), %

Contacts Per Case .................................... (c1 ÷ a1) (c2 ÷ a2) (c ÷ a)

Evaluation Rate ......................................... (d1 ÷ c1), % (d2 ÷ c2), % (d ÷ c), %

Disease Rate ............................................. (e1 ÷ d1), % (e2 ÷ d2), % (e ÷ d), %

Latent Infection Rate ................................. (f1 ÷ d1), % (f2 ÷ d2), % (f ÷ d), %

Treatment Rate ......................................... (g1 ÷ f1), % (g2 ÷ f2), % (g ÷ f), %

Completion Rate ....................................... (h1 ÷ g1), % (h2 ÷ g2), % (h ÷ g), %

CDPH 8635 A & B (9/07; Revised 12/11) Instructions Page 3 of 8

Basic Instructions for the California Aggregate Reports for Tuberculosis Program Evaluation:

Follow-up and Treatment for Contacts to Tuberculosis Cases, Preliminary and Final Reports Note: The instructions for this report are not a substitute for guidelines about tuberculosis (TB) diagnosis, treatment, or control. Any contradictions between the implied content of these instructions and the health department’s policies and practices should be discussed, according to the context, with a consultant from the local or state TB program or the Centers for Disease Control and Prevention (CDC) Division of Tuberculosis Elimination (DTBE). This report is an annual summary of the core activities of eliciting and evaluating contacts to TB cases and treating the contacts who have latent TB infection. The health department also may include results that are provided by partner or contract health care entities, if the health department has assurance that the data are satisfactory. This generally means that the other entities have cooperated with the health department in confirming the results from contact evaluations and in managing the treatment of contacts who have latent TB infection. Aggregate Reports for Tuberculosis Program Evaluation (ARPE) (California instructions)- There are two forms used in California to report contact investigation aggregate data for TB program evaluation. Local health departments reporting one or more cases during the cohort period are required to complete and submit the California ARPE: Follow-up and Treatment for Contacts to TB Cases (CA ARPE-CI) Preliminary and Final Report forms. Jurisdictions with no cases counted during the cohort period are not required to submit an ARPE form. CA ARPE-CI Preliminary and Final Reports (California instructions). CDPH TBCB modified the CDC ARPE-CI to create two CDPH forms. CDPH 8635 A is the California ARPE-CI Preliminary Report form (CA ARPE-CI Prelim). CDPH 8635 B is the California ARPE-CI Final Report form (CA ARPE-CI Final). Please use these forms when reporting contact data to the TBCB. The CA ARPE-CI Prelim (CDPH 8635 A) includes Part 1 through “Started Treatment” (row g), plus the corresponding Part II. Evaluation Indices (all indices excluding Completion Rate). The portions of the form which should not be included in the Prelim report are greyed out on the CA ARPE-CI Prelim form. The CA ARPE-CI Final (CDPH 8635 B) comprises the complete ARPE form and includes the previously submitted CA ARPE-CI Prelim data for the given cohort. Reporting Schedule (California instructions). Submission dates for the CA ARPE-CI Prelim reports are scheduled for approximately three and a half months after the end of the cohort. The CA ARPE-CI Final reports are due to TBCB one year after the CA ARPE-CI Prelim reports. CA ARPE-CI Prelim and Final report forms and instructions will be mailed to all local health departments two months prior to the submission deadline. Please refer to the ‘Schedule for Reporting Contacts to TB Cases in California’ for specific dates by which all local health departments in California should submit the CA ARPE-CI Prelim and Final reports. LINK: http://www.cdph.ca.gov/programs/tb/Documents/TBCB-ARPE-Schedule.pdf CA ARPE Form Instructions Cohort (California instructions). ARPE data are accumulated into cohorts that each cover half the calendar year (i.e. January-June, July-December). Contacts are assigned to the cohort time period in which the index TB cases were counted and reported to the State using the count date (variable #6 “Month-Year Counted” on the Report of Verified Case of TB) for the case to which the contact is linked. A person included in more than one contact investigation in a cohort period should be counted for each event, but contacts exposed to multiple TB cases connected to a single contact investigation (i.e. index and secondary cases) should each be counted only once. Total TB Cases Reported. This is the total surveillance TB case count for the cohort period including cases without associated contact investigations.


Part I. Cases and Contacts Types of Cases for Investigation (Data Columns): The TB cases, their contacts, and all the subsequent results are grouped into the following three categorical columns according to the type of TB case leading to the contact investigation. Sputum smear (+). All of the following criteria must be met to count cases in this category:

1. inclusion in the overall surveillance count, 2. disease site in the respiratory system including the airways, and 3. positive AFB sputum smear result, whether or not any culture result is positive.

Cases should be counted in this category even if contacts could not be elicited for any reason (e.g., the patient left the area or died before an interview could be done). Sputum smear (-), cult. or NAAT (+). All of the following criteria must be met for counting cases under this category:

1. inclusion in the overall surveillance count, 2. disease site in the respiratory system including the airways, 3. negative AFB sputum smear results, and 4. sputum culture or NAAT1 result positive for Mycobacterium tuberculosis complex.

Cases should be counted under this category even if contacts could not be elicited for any reason. Other Pulmonary (California instructions). This category includes contact investigations conducted for verified pulmonary/laryngeal TB cases not included in the other two case categories. Example: Clinically confirmed TB or TB confirmed by a bronchial wash, not sputum, sample. Cases should be counted under this category even if contacts could not be elicited for any reason. Please note that this box is shaded on the federal CDC ARPE-CI form but is not shaded on the California ARPE-CI forms. Data Rows: Cases for Investigation (California instructions). TB cases for whom contact investigations are indicated are counted here whether or not an investigation was performed. The TB cases are grouped into the three above categorical columns according to the type of TB case leading to the contact investigation. Please note, source case investigations for pediatric cases are not reportable on the ARPE-CI. Cases With No Contacts (California instructions). Cases counted in “Cases for Investigation” are reported here if no contacts were elicited, regardless of the reason contacts were not elicited. Please note that the box for this count is shaded for the “Others” case category on the federal CDC ARPE-CI form but is not shaded on the California ARPE-CI forms. Number of Contacts (California instructions). All the following criteria must be met to count a person exposed to TB as a contact for this report:

1. The health department believes the person was exposed, warranting an evaluation for TB disease or latent infection. The following list of factors should be considered when determining whether evaluation is warranted for a contact: Infectiousness of source case Proximity of contacts Duration of exposure Host susceptibility of contact (e.g. immunosuppression, child, other high risk factors) Environmental characteristics affecting transmission (e.g. ventilation, size of space) Evidence of transmission.

2. The exposure was caused by a TB case counted by the reporting jurisdiction.

1 The MMWR report, “Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis,” provides information on the NAA tests that have been approved by the Food and Drug Administration for use with AFB smear-positive respiratory specimens. Accessible at www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm.


3. Enough information is available to verify a current location or phone number for the named

contact, regardless of whether the person is in the jurisdiction of the health department. The follow-up of out-of-jurisdiction contacts usually requires the assistance of the health departments in those other jurisdictions.

Note: Persons should not be included in the contact count if, as judged by the health department, they do not need to be evaluated. This may occur, for example, when the concentric circle model is used. If evaluation of contacts with the greatest exposure (i.e., “close contacts”) revealed no evidence of transmission, the health department may determine that other contacts, who are not high-risk, and had less exposure do not require evaluation. These contacts should not be included in the ARPE “Number of Contacts.” Note: Contacts associated with a TB case located in another jurisdiction are counted by the jurisdiction reporting the TB case, not the jurisdiction in which the contact is located. Evaluated (California instructions). This is the number of contacts for whom the indicated evaluation step listed below has been completed, as part of a contact investigation, to the point where a final determination can be made about three of the potential diagnostic outcomes: latent TB infection, TB disease (see below for reporting definitions of these outcomes), or neither.

Indications Evaluation Step ALL CONTACTS Interview2, and

Symptom review Contacts with no documented history of positive Tuberculin Skin Test (TST) or Interferon Gamma Release Assay (IGRA) or TB disease

TST #1 placed and read3, or IGRA #1 performed and results received.

Contacts with TST #1 placed or IGRA #1 performed < 8 weeks from last exposure, and with a negative TST or IGRA #1

TST #2 placed and read3, or IGRA #2 performed and results received.

Contacts with documented history of positive TST or IGRA

Chest imaging study4

Contacts with: TB symptoms present, or Positive TST or IGRA #1 or positive TST or IGRA #2,

or History of TB disease, or HIV-infection, risk for HIV infection5, or age < 4 years

Medical evaluation6, and Chest imaging study4

Note about contacts having prior TB disease or latent infection: CA ARPE-CI Prelim and Final contact reports only include those contact evaluation results determined through contact investigations. Contacts

2 Interview includes query regarding: symptoms, history of latent TB infection or TB disease, documented previous TST results, previous treatment for latent TB infection or TB disease, risk factors for developing TB disease or, other conditions of immunosuppression that are associated both with anergy or false TST positive results, and that are associated with high risk of progression from infection to disease (e.g. patients who are undergoing immunosuppressive therapy, patients who have leukemia or Hodgkin’s disease).

3 Skin tests with other antigens, for cutaneous anergy, should not be considered for classifying outcomes for this report. 4 May not need to obtain a new chest radiograph if a chest radiograph was done within the preceding six months. 5 Please see the California TB Controllers Association/California Department of Health Services Joint Guidelines for TB Treatment

and Control in California, Contact Investigation Guidelines. (11/98) Appendix 3, page 22, for a list of factors associated with increased risk of HIV infection.

6 Medical evaluation is an in-person evaluation by a physician or other appropriately licensed practitioner.


with a known history of TB disease or latent infection prior to a contact investigation should, however, be included in the Number of Contacts. And generally, these contacts can also be counted under Evaluated if their evaluation is completed according to the ‘Evaluated’ table. However, the diagnostic and treatment outcomes are not counted in the CA ARPE-CI Prelim or Final reports. Contacts with a known history of TB disease or latent infection prior to contact investigation should be included in the ARPE-CI count of contacts identified. However, their treatment for LTBI should NOT be included in this report. Also, see “Started Treatment” below. TB Disease. Contacts should be counted under this outcome if they have TB disease (i.e., active TB) diagnosed as part of the contact investigation. Cases must fit the CDC Report of a Verified Case of Tuberculosis (RVCT) definition and should be referred for morbidity surveillance according to the reporting requirements. Persons with active TB disease that developed after latent infection was diagnosed during the contact investigation should not be counted in this category. Persons with a history of TB who have been previously treated or have spontaneously healed, and persons with TB disease diagnosed coincidentally (i.e., not because of the contact investigation) should also not be counted in this category. Note about DNA fingerprinting (i.e., RFLP or “strain” typing): results of DNA fingerprinting of Mycobacterium tuberculosis isolates should be ignored when counting contacts under TB Disease even when fingerprinting results disprove a transmission link. The count for TB Disease should be tabulated for this report as though DNA fingerprinting were unavailable. Latent TB Infection. This is the count of contacts with latent TB infection (not TB disease) diagnosed through current contact investigations. Both of the following criteria must be met:

1. new positive result of a current tuberculin skin test (as interpreted according to California diagnostic guidelines), and

2. exclusion of active TB disease through further tests or examinations. Latent TB infections diagnosed coincidentally or prior to the contact investigation (prior positive TST) should be not be included in this count. Note about “anergy”: in determining whether to count a contact under Latent TB Infection, only results from a tuberculin test should be considered, not from skin tests with other antigens (i.e., “control” antigens or an “anergy panel”). If, however, a contact with a negative tuberculin skin test result is being treated with a full-course regimen for suspected latent TB infection, that contact should be counted under Latent TB Infection. Started Treatment. A contact with latent TB infection is counted in this category after the first dose of a planned full treatment course for latent TB infection. The determination of whether the first dose has been taken is based on the best available information which is often the contact’s statement. If a contact is lost to follow-up after treatment was prescribed, and information is unavailable about whether any medication was taken, then treatment can be considered started if the contact picked up the medicine from a clinic or pharmacy. Note about “window-period treatment”: contacts receiving treatment pending a second tuberculin skin test or IGRA (i.e., window-period treatment) should not be counted under Started Treatment unless latent TB infection is diagnosed finally and counted for the report. When contacts with a known history of TB disease or latent infection prior to contact investigation are treated, their treatment information should not be included in this report. Completed Treatment. (Note: this category is based partly on an arbitrary, operational definition of completion. It might not be equivalent to an adequate course of therapy.) The following criteria are required for counting under this category:

1. the prescribing provider, believing that an adequate regimen has been received, discontinues treatment,

2. the contact has taken at least 80% of the prescribed doses in the selected regimen, and 3. the treatment is finished within a period of 150% of the selected duration of therapy.


Determination of whether the definition of “completed treatment” is met is made from the best available information, which is generally the provider’s records and the contact’s statements about adherence to treatment. Reasons Treatment not Completed: this section catalogues some general reasons that the treatment for latent TB infection is not being completed. Death. Contacts receiving treatment on schedule who had treatment interrupted by death before completing are counted under this category. (Note: Because of the seriousness of this outcome and the unreliability of anecdotal reports, a verification check of all deaths is helpful for accuracy in reporting.) Contact Moved (follow-up unknown). Contacts who do not complete treatment because they have moved or migrated from the health department jurisdiction should be counted in this category when follow-up information is unavailable. If, however, the health department receives specific follow-up from another jurisdiction (e.g., Completed Treatment or Patient is Lost to Follow-up), then that outcome should be reported. Active TB Developed. If a contact who is receiving treatment for latent TB infection develops active TB, that qualifies as a case under the standard surveillance definition (i.e., RVCT), then the outcome is counted in this category. If, however, the treatment regimen has already been stopped before active TB developed, because of completion or any other reason, then the outcome should not be reported as Active TB Developed. Adverse Effect of Medicine. If contacts do not complete treatment because of an adverse effect (including drug-drug or drug-food interactions) of the anti-TB medication, they should be counted in this group provided that a health care provider documents the problem and determines that the medicine should be discontinued. If a contact stops taking the medicine because of an adverse effect but a provider has not recommended the discontinuation, then the reason for stopping treatment should be counted as Contact Chose to Stop. Note on reporting adverse events associated with treatment of LTBI: To monitor adverse effects, CDC has established an LTBI treatment adverse effects surveillance system. Adverse effects leading to hospital admission or death should be reported to Janice Westenhouse ([email protected]) at the California Department of Public Health for inclusion in this system. Adverse events or medication errors also should be reported to FDA MedWatch at http://www.fda.gov/medwatch, by submitting a MedWatch Form 3500 (available at http://www.fda.gov/medwatch/safety/FDA-3500_fillable.pdf ) or by calling 1-800-FDA-1088. Contact Chose to Stop. Contacts should be counted in this category if they decide to stop taking their medicine before they have finished their regimen and a health care provider has not determined that the medicine should be discontinued for a medical reason. Contact is Lost to follow-up. Contacts whose treatment status at the anticipated end of the treatment regimen is incomplete or indeterminate because the health department cannot locate them to determine a more specific outcome should be counted in this category. Provider Decision. Contacts whose treatment is discontinued because a health care provider determines that treatment for latent TB infection should be stopped due of concerns about the benefits, safety, or practicality of treatment (e.g., a contact has such erratic attendance at the clinic that the adequacy and the safety of the treatment cannot be monitored) should be counted in this category. Still on Treatment. Contacts who are still on treatment at the time the Final report is due should be counted in this category. Part II. Evaluation Indices. This part of the contact follow-up report contains the summary statistics calculated from the aggregate data in Part I of the report. The formulae for each cell are shown in the paper-copy table.


(California instructions). Manual calculation and reporting of these indices is required when using the paper CA ARPE-CI Prelim and Final reports. These indices can help evaluate contact investigation activities in local health jurisdictions.