Tuberculosis policy and procedure manual 2009

1
Georgia Tuberculosis
Policy
and
Procedure Manual
2009
Georgia Department of Community Health
Division of Public Health Infectious Disease and Immunization Program
Office of Infectious Disease Tuberculosis Unit
404-657-2634 Fax: 404-463-3460 http://health.state.ga.us/programs/tb/

2
Acknowledgements
Editors: Kathy Kolaski, R.N., M.S.N., C.N.S., Program/PHSO Nurse Consultant, TB Unit Ann Poole, R.N., A.S., Acting Assistant Unit Manager, Program/PHSO Nurse Consultant, TB Unit
Division of Public Health Rhonda M. Medows, M.D., M.P.H, Acting Director
Infectious Disease and Immunization Program Michelle Conner, R.N., M.S., M.B.A., Acting Director Office of Infectious Disease Jevon Gibson, M.A., Director
TB Unit Michael Leonard, M.D., Medical Consultant Rose-Marie Sales, M.D., M.P.H., Medical Epidemiologist Karen Buford, R.N., M.S., M.S.N., Acting Unit Manager/Nurse Consultant Gaynell Dryer-Williams, R.N., B.S.N., Nurse Specialist/Educator Shawndra Daniel, B.S., Operations Analyst II Edna Cox, Unit Assistant Office of Pharmacy Kimberly Hazelwood, Pharm. D. Donelle Humphrey-Franklin, R.P.H, M.B.A. Georgia Public Health Laboratory Elizabeth Franko, Dr.P.H., Director Mahin Park, Ph.D., H.C.L.D., Director, Clinical Microbiology Jane Bush, B.S., MT (ASCP), Manager, Mycobacteriology/Mycology Unit American Lung Association of the Southeast Pamela Collins, M.P.A., M.S.A. District TB Coordinators
Georgia Tuberculosis Policy and Procedure Manual 2009

3

I. Mission Statement

Table of Contents

Page 4

II. Responsibilities

5

III. Surveillance

14

IV. Classification System for TB

17

V. Management and Disposition of TB Suspects

18

VI. Tuberculosis Medical Records

20

VII. Transmission and Pathogenesis of Tuberculosis

23

VIII. Diagnosis of Tuberculosis Disease

27

IX. Treatment of TB Disease

47

X. Contact Investigation

49

XI. Tuberculosis Infection

53

XII. Pharmacy Information

55

XIII. Infection Control

62

XIV. Program Evaluation

66

XV. Tuberculosis Confinement and Georgia Laws

67

XVI. Glossary of Tuberculosis Terms

85

XVII. Resources

98

XVIII. Appendices

A. Alternative Housing Project for Homeless Clients

102

B. Commitment Templates

119

C. Mycobacteriology Lab Tests

136

D. Policies and Procedures for Directly Observed Therapy

148

E. Policies and Procedures for Tuberculin Skin Test

170

F. Sputum Collection and Drug Levels

176

G. Uniform Clinical Performance Measures for Case Managers

180

Georgia Tuberculosis Policy and Procedure Manual 2009

4

I.

GEORGIA TUBERCULOSIS PROGRAM

MISSION STATEMENT

The mission of the Georgia Tuberculosis (TB) Program is to control transmission, prevent illness and ensure treatment of disease due to tuberculosis. This is accomplished by the following:
1. Identifying and treating persons who have active TB disease
2. Finding, screening and treating contacts
3. Screening high-risk populations
The TB Program has the legal responsibility for all TB clients in Georgia regardless of who provides the direct services (see section XVIII, Tuberculosis Laws, page 73). TB Program services are available to all who fall within the service criteria without regard to the client's ability to pay.

Georgia Tuberculosis Policy and Procedure Manual 2009

5
II. RESPONSIBILITIES FOR CONTROL OF TUBERCULOSIS
1. RESPONSIBILITY OF THE STATE TUBERCULOSIS PROGRAM
Tuberculosis services in Georgia are provided on a cooperative basis by local county health departments, district health offices, the private medical sector, other public agencies and the Georgia Tuberculosis Program. (Rules of Department of Human Resources, Public Health, Chapter 290-5-16)
State Tuberculosis Program Staff
A. Administration
1. Formulate and distribute state tuberculosis policies, procedures and protocols.
2. Provide surveillance, epidemiological analysis and evaluation data to districts and counties for reports, talking points, presentations and program planning purposes.
3. Assist districts and counties in the establishment of on-site surveillance responsibility.
4. Maintain automated client management and surveillance system.
5. Provide program evaluation, technical consultation and support.
6. Maintain budget and financial data.
7. Maintain medical records on TB cases for at least twenty-one (21) years. Information should include the following: Name, birth date, county, medications, drug susceptibilities, and record of disposition.
8. Obtain documentation for out-of-state cases and/or contacts. Provide information to requesting district/county health departments.
B. Physician Consultant
1. Provide recommendations for treatment of tuberculosis to district contract physicians, as needed.
2. Provide medical consultation to local health departments, private physicians, other providers and agencies, as requested.
3. Coordinate treatment of tuberculosis with private physicians and other providers, as needed.
Georgia Tuberculosis Policy and Procedure Manual 2009

6
4. Review all cases and suspects to ensure quality and appropriate treatment regimens.
C. Nursing Consultant/Specialist
1. Coordinate educational programs for health departments, nursing homes, hospitals, correctional facilities, private industries and all other public and private entities, as requested.
2. Maintain listing of current educational materials and information on proper management and treatment of tuberculosis and act as a resource to provide these materials and information, as requested.
3. Consult with district health departments, correctional facilities, hospitals, and all other health care providers on general concerns regarding tuberculosis management and/or specific tuberculosis cases.
4. Conduct site visits to local county health departments and district facilities for technical consultation, quality assurance and quality improvement.
5. Assist in development of TB policies, procedures and protocols.
D. Medical Records and Surveillance
1. Maintain the State Electronic Notifiable Disease Surveillance System (SENDSS)/Tuberculosis Information Management System (TIMS) Database, which includes, but is not limited to, the Client Surveillance and Client Management Modules.
2. Maintain the Electronic Disease Notification System (EDN) which is used as a data transmission portal and retrieval system and includes monitoring the TB status of immigrants/refugees.
3. Train and update district and county personnel on entering data into the SENDSS Database.
4. Establish, update and maintain charts for all tuberculosis suspects and tuberculosis cases.
5. Verify and count all cases of tuberculosis for the State of Georgia and transmit surveillance statistics to the Center for Disease Control.
6. Monitor accuracy of data, establish files and internal databases, back up files, enter data and maintain tuberculosis documentation.
Georgia Tuberculosis Policy and Procedure Manual 2009

7
7. Produce and distribute informational reports at regularly scheduled intervals or as requested.
8. Provide administrative support for the Tuberculosis Program.
E. Outreach
1. Provide consultation to the districts regarding the complete care of complex cases. This may include the following:
a. Collaborative efforts with clinical staff in the development of comprehensive treatment plans.
b. Providing recommendations for services or resources that are available and suitable for the client.
2. Develop and implement policies, procedures and forms as related to the functioning of the Outreach Team.
3. Provide education and training to both the district and in-house staff regarding the operations of the Outreach Team or relative outreach issues.
4. Provide temporary outreach assistance to the districts. Outreach assistance may include the following:
a. Case Management follow-up with difficult clients. b. Conducting staff needs-assessment to determine service gaps.
F. Epidemiology
1. Analyze data to describe tuberculosis morbidity and mortality, trend and geographic characteristics of TB cases.
2. Monitor TB incidence in high-risk populations, appropriateness of TB treatment regimen and resistance levels to anti-TB drugs.
3. Evaluate implementation of core TB program strategies and attainment of program outcome measures such as completion of therapy, treatment for active TB disease and latent TB infection among contacts, contact evaluation, follow-up and directly observed therapy.
4. Conduct outbreak investigations, other epidemiologic studies and evaluation of special project interventions.
Georgia Tuberculosis Policy and Procedure Manual 2009

8
5. Review secondary data sources (e.g. AIDS registries, laboratory reports) to detect failure to report cases.
6. Review completeness, accuracy and timeliness of surveillance data.
7. Produce the annual Georgia TB Report, annual progress reports and program management reports.
8. Interpret data to assist in development of program policies and procedures.
9. Respond to inquiries on TB statistics
2. DISTRICT RESPONSIBILITIES
A. District Health Director
1. Has the ultimate responsibility for ensuring that county health departments within the district implement TB guidelines, policies and procedures, protocols; provide supervision and delegate activities to staff as directed by the State TB Program.
2. Produce and deliver health order directives as first legal step to ensure compliance for evaluation and/or treatment of tuberculosis.
3. Develop and maintain a working relationship with the county attorneys and the sheriff's offices in the district to facilitate court ordered therapy.
B. District Contract Physician/Consultant
1. Provide for the overall medical management of clients in the county health department TB programs.
2. Remain knowledgeable on current recommendations regarding the clinical management of TB disease and infection.
3. Consult with the State TB Program when making recommendations for the treatment of multi-drug resistant (MDR) tuberculosis (TB resistant to at least Isoniazid and Rifampin) prior to prescribing secondary drug regimens.
4. Meet with the state medical consultant annually.
5. Monitor the care and treatment of clients with TB disease and infection being followed by private physicians.
6. Provide recommendations on the following clients within the specified time frames:
Georgia Tuberculosis Policy and Procedure Manual 2009

9
a. Suspect/case within forty-eight (48) hours. b. Close contact to TB cases and suspects and all children within five
(5) working days. c. All other clients within thirty (30) days.
C. District TB Coordinators
1. Provide oversight, consultation and assistance to county health department TB program staff.
2. Provide consultation and assistance to other health care providers (e.g., hospitals, nursing homes, private physicians, correctional facilities, etc.).
3. Provide in-service training for tuberculosis to county health departments, local communities and other agencies.
4. Evaluate follow-up of suspects, cases, contacts and persons on Latent TB Therapy (LTBI) therapy.
5. Submit the following to the State TB office: a. Case reports (RVCT, Follow-up 1 & 2) via SENDSS b. Quarterly Grant-in-Aid report c. Client information on all cases and suspects including:
o Physicians' Notes o Progress Reports o Admission and Discharge Summaries o Bacteriology Results and Lab reports o Radiology Results o Contact Investigation Forms o Any supporting documentation
6. Develop district policies, procedures and protocols under direction of the Health Director.
7. Serve as the point of contact for counties needing emergency and longterm housing services for infectious, homeless or non-compliant clients. Identifies and establishes partnerships with local resources to provide placement as needed
8. Facilitate court ordered treatment.
9. Facilitate hospitalization (when needed).
Georgia Tuberculosis Policy and Procedure Manual 2009

10
3. COUNTY HEALTH DEPARTMENT RESPONSIBILITIES
County Health Departments are ultimately responsible for the medical supervision and case management of all known cases and suspects in order to prevent the spread of tuberculosis within their county. Each county health department should have a designated TB nurse with the following responsibilities.
A. TB Nurse
1. Receive reports of suspects/cases from other health care providers and promptly submit these reports (physicians' notes, progress notes, admission and discharge notes, bacteriology and radiology results) to the district TB Coordinator.
2. Provide case management and follow-up of all known TB clients (cases, suspects, contacts, LTBI) to ensure timely and appropriate treatment.
3. Submit reports of all new cases on the Report of Verified Case of TB form (RVCT) to the District TB Coordinator.
4. Coordination of contact investigation to include documentation of screening and completion of contact investigation form.
5. Provide tuberculin skin testing as requested.
6. Provide tuberculosis medical, nursing and epidemiological consultation.
7. Cooperate with and assist private physicians responsible for treating tuberculosis clients.
8. Obtain information from physicians who provide the care and medical management of TB clients assuring the private provider completes the "Initial Report on Clients with TB" form 3141 and "Follow-up Report on Clients" form 3142.
9. Educate TB suspects, cases, persons on LTBI treatment and their families about tuberculosis.
10. Facilitate the enforcement, when necessary, of tuberculosis laws and regulations to protect the health of the public.
11. Refer clients to other health care providers as needs are identified (e.g. social services, substance abuse treatment centers, nutrition services, alternate housing project, etc.).
Georgia Tuberculosis Policy and Procedure Manual 2009

11 12. Provide documentation for and participate in local, district and state
case reviews. 13. Responsible for duties of CDS/Outreach Worker, in the event this
worker or position is not available. B. Communicable Disease Specialist/Outreach Worker
Based on local policy, responsibilities may include some or all of these duties: 1. Initiate contact investigation on cases and suspects. 2. Provide tuberculin skin testing to contacts and/or refer to a location
where they can receive a skin test. 3. Provide Directly Observed Therapy (DOT) and/or Directly Observed
LTBI Therapy (DOPT). 4. Follow-up and track TB clients who miss appointments. 5. Coordinate transportation for clinic appointments. 6. Obtain sputum specimens, as requested. 7. Educate clients and families about tuberculosis. 8. Provide reports to TB Nurse and/or District Coordinator as requested. If there is no communicable disease specialist or outreach worker with assigned duties, these responsibilities will be required of the TB Nurse.
Georgia Tuberculosis Policy and Procedure Manual 2009

12
4. PRIVATE MEDICAL SECTOR AND OTHER PROVIDERS OF CARE
Physicians and other providers of care are legally required to report all diagnosed and/or suspected cases of tuberculosis to local or state health departments. County health departments are required to report all diagnosed and suspected cases of tuberculosis to the Tuberculosis Program through their district offices.
A. Private Medical Management
Local county health departments collaborate with medical management providers (e.g. VA, private health care providers) not associated with local health departments that choose to provide medical services for TB cases/suspects. These providers are required to:
1. Report all suspected and diagnosed cases of tuberculosis to local health departments on forms 3140 or 3141. (Rules of Department of Human Resources, Public Health, Chapter 290-5-16)
2. Provide reports regarding a client's current status, including bacteriologic, x-ray and clinical findings on Form 3142. (http://health.state.ga.us/programs/tb).
3. Collect sputum specimens monthly and report results to local county health departments to ensure documentation of sputum conversion from positive to negative or lack of conversion.
4. Refer client to health department for contact investigation or submit report of such investigation. (Rules of Department of Human Resources, Public Health, Chapter 290-5-16.02)
5. Provide Directly Observed Therapy (DOT) or refer client to health department for DOT.
B. Joint Medical Management
Joint medical management is an agreement between the local health department and a private medical provider that ensures complete and appropriate medical care for the TB case/suspect.
1. Clients utilizing state TB drugs must be evaluated and followed under health department protocol and guidelines.
2. DOT is the standard of care and must be provided on all cases, suspects and children less than 5 years of age with LTBI.
3. Clinical Case Management must include:
Georgia Tuberculosis Policy and Procedure Manual 2009

13
a. Sputum examination b. Baseline and ongoing laboratory results/blood work (Obtain
AST (SGOT), ALT (SGPT), bilirubin, alkaline phosphatase, CBC with platelet count, serum uric acid and serum creatinine for all adults. Hepatitis B and C profile, if indicated (e.g., injection drug use, foreign birth in Asia or Africa, HIV infection). HIV antibody test (confidential) and counseling, with client consent and appropriate documentation. If HIV-infected, obtain CD4 T-cell count.) c. Chest X-ray d. Visual acuity/color as indicated e. Hearing as indicated f. Monthly monitoring for adverse reactions and patient status g. Contact Follow-up (If contact follow-up is done by the private physician, the results of this must be provided to the county health department). Each party will submit monthly reports on the client's condition to the other provider utilizing form 3142 (Follow-up Report on Client With Tuberculosis). C. Hospitals and Private Laboratories Hospitals and private laboratories with Level I and Level II Licensure (see Rules and Regulations of Licensure of Clinical Laboratories Chapter 290529, Rules of Department of Human Resources Public Health) are required to submit positive cultures of mycobacterium species to the State Laboratory for confirmation and species identification. Laboratories with Level III Licensure are required to report all laboratory findings regarding tuberculosis directly to the State of Georgia Tuberculosis Program.
Georgia Tuberculosis Policy and Procedure Manual 2009

14
III. SURVEILLANCE
A. General Considerations
The Georgia TB Program has the legal responsibility for all TB clients in the state regardless of who provides the direct services.
Legislative authority
Official Code of Georgia Annotated (O.C.G.A.) Sections 31-2-1, 31-12-2 and 3112-4. O.C.G.A Section 31-14-1 et seq. http://www.legis.state.ga.us
Rules and Regulations of the State of Georgia Department of Human Resources/ Public Health/ Tuberculosis Control, Chapter 290-5-16 et seq. http://rules.sos.state.ga.us/
Reporting requirements
In Georgia, all tuberculosis must be reported immediately to the local county health department. Physicians, hospitals, laboratories and other health care providers are required to report any of the following:
Any child less than 5 years of age discovered with Latent TB Infection Any confirmed case of TB Any suspected case of TB Any person being treated with two (2) or more anti- tuberculosis drugs Any positive culture for Mycobacterium tuberculosis Any positive smear for AFB (Acid Fast Bacilli)
State Electronic Notification Disease Surveillance System (SENDSS)
All reports of the above will be entered electronically through the State Electronic Notification Disease Surveillance System (SENDSS) at http://sendss.state.ga.us
Update in SENDSS all suspects within 90 days to a verified case or not a TB case.
Reporting and Counting Cases of M. Tuberculosis
The district TB coordinator or designee shall report new cases of tuberculosis promptly to the TB Program office utilizing the TB patient management module via SENDSS. Each TB case is reviewed to ensure that it meets the reporting criteria. All cases that meet the criteria are termed verified TB cases and are counted annually. It is imperative information be submitted timely to ensure all verified cases are counted in the year of verification. Report to State Office/TB Coordinator any information concerning TB/HIV coinfected patients, MDR cases, airline flight exposures, clusters of TB, instances that might precipitate media attention and children suspected of or diagnosed with TB.
Georgia Tuberculosis Policy and Procedure Manual 2009

15
B. Case Definitions
1. Laboratory
Isolation of M. Tuberculosis complex from clinical specimen.
2. Clinical
In the absence of a laboratory confirmation of M. tuberculosis, a person must have evidence of the following to be considered a clinical case of tuberculosis: a. Positive tuberculin skin test b. An abnormal or unstable (worsening or improving) chest radiograph c. Symptoms of current tuberculosis disease (e.g., fever, night sweats,
cough, weight loss, hemoptysis) d. Receiving treatment with 2 or more anti-tuberculosis medications.
3. Provider Diagnosis
If a case does not meet the laboratory or clinical case definition, the case may be counted as a verified case of tuberculosis by provider diagnosis if evidence of TB is present and a client makes clinical improvements with medications.
4. Reactivated or relapse cases
A case should not be counted twice within a twelve (12) month period. To report a case as being reactivated, 12 months should have elapsed since the client was discharged, lost to the follow-up or the case was closed. A case that becomes culture positive or clinically indicative of active disease 6-12 months after completion of therapy is considered a relapse and is not counted again for surveillance purposes.
5. Nontuberculous Mycobacterial Disease (NTM) a. A person who has disease attributed to or caused by NTM only should not be counted or reported as a case of tuberculosis. b. A person who has tuberculosis disease diagnosed with both M. tuberculosis and other NTM shall be counted and reported as a case of tuberculosis.
6. Tuberculosis case diagnosed after death Tuberculosis cases reported to health departments should be reported and counted as a case if evidence of current disease was present at time of death
Georgia Tuberculosis Policy and Procedure Manual 2009

16
C. Reporting LTBI
The finding of LTBI in a child less than five years of age is a reportable/notifiable disease.
. D. Surveillance Reporting Timelines
Time lines for entering data into SENDSS and sending required documentation to Medical Records/Surveillance.
1. Main Form must be entered in SENDSS as soon as the patient is reported to public health (county district or state level).
2. Initial form should be entered as soon as the patient becomes a verified case of tuberculosis.
3. Follow-up 1 Enter in SENDSS as soon as possible after receipt of documentation of the susceptibility report from the lab(s).
4. Follow-up 2 Enter in SENDSS as soon as possible after the client has completed therapy.
5. Clinical forms Send to medical records as soon as possible (New suspect referral, NTCA 3-2002, progress notes, chest x-ray report , hospital discharge summaries, any other pertinent information) as soon as possible.
6. Contact Investigation As soon as contacts are identified.
E. Surveillance Follow-up
1. When the client relocates out of the state, the district office will notify the state office. The state office will notify the new state of residence. Upon completion of the therapy in the new state of residence, the state office will obtain the follow-up 2 and enter it in SENDSS. If a client dies and has a diagnosis of M. tuberculosis, the patient should be entered in SENDSS and processed as a regular case (main form, initial form, follow-up 1, if applicable, and contact investigation).
2. Contact the state office medical records/surveillance unit about transfers from other jurisdictions (other counties, districts, states) who have been started on TB medical treatment regimens. The state office staff will assist in the determination of the client's count status.
Georgia Tuberculosis Policy and Procedure Manual 2009

17
IV. CLASSIFICATION SYSTEM FOR TB
The current classification system for TB is based on the pathogenesis of the disease. A client should not have a class five classification for more than three months.
All persons with class three or class five TB should be reported promptly to the state or local health department. Health care providers should comply with state and local laws and regulations requiring the reporting of TB

Classification Table for Tuberculosis

Class 0 I II III IV
V

Type No exposure to TB, Not infected Exposure to TB, No evidence of infection TB infection, No TB disease
Current TB disease
Previous TB disease
TB suspected

Description No history of exposure, negative reaction to the tuberculin skin test History of exposure, negative reaction to a tuberculin skin test given at least 10 weeks after exposure
Positive reaction to the tuberculin skin test, negative smears and cultures (if done), no clinical or x-ray evidence of TB disease Positive culture for M. tuberculosis (if done), or a positive reaction to the tuberculin skin test and clinical or x-ray evidence of current TB disease Medical history of TB disease, or abnormal but stable x-ray findings for a person who has a positive reaction to the tuberculin skin test, negative smears and cultures (if done), and no clinical or x-ray evidence of current TB disease Signs and symptoms of TB disease, but evaluation not complete. Diagnosis pending.

Georgia Tuberculosis Policy and Procedure Manual 2009

18
V. MANAGEMENT AND DISPOSITION OF TB SUSPECTS
A. Suspect Criteria
1. The client has a prescription for two or more TB drugs and one or more of the following:
a. Signs/symptoms of tuberculosis b. Positive AFB smear c. Abnormal chest x-ray d. History of exposure to tuberculosis
Note: It is possible for an old TB case to be considered as a suspect based on an abnormal chest x-ray and/or current symptoms. However, a relapse is not considered to be a new case unless twelve (12) months have passed since the client was discharged from supervision, the case was closed or the client was lost to service.
2. Initial sputum reports, microbiology reports, prescriptions, chest x-ray reports and other provider notes are screened by the TB physicians. If the client meets the above criteria, they will be placed on the active suspect list. Suspects from districts with contract physicians are placed on the list based on recommendations from clinic notes.
B. Management
1. A list of suspects from all counties will be dispersed to each district.
2. Clinical management: See Nurse Protocol Manual (hard copy or http://health.state.ga.us/programs/nursing/publications.asp) for TB cases/suspects.
3. Contact Investigation:
The nurse or designee should initiate a contact investigation for all contacts immediately. (See Contact Investigations, Section XIII, page 57)
4. The District TB Coordinators are to forward the following information to the TB Program:
a. Physician Notes b. Progress reports c. Admission and Discharge summaries d. Laboratory reports e. Radiology results
Georgia Tuberculosis Policy and Procedure Manual 2009

19 C. Disposition
The goal of the TB Program is to obtain a disposition on suspects within three (3) months. A suspect's disposition may be: 1. Active TB disease 2. Ruled out TB disease 3. Nontuberculous mycobacteria (NTM, MOTT or atypical TB)
Georgia Tuberculosis Policy and Procedure Manual 2009

20
VI. TUBERCULOSIS MEDICAL RECORDS
A. Confidentiality/Release of Record
All tuberculosis records are confidential. Their release to health and non-health agencies (excluding agencies within DHR) and Quality Service Agreements should be made only with a signed authorization to release information. Health Insurance Portability and Accountability Act (HIPAA) guidelines must be followed. Information about HIPAA is available on the public health HIPAA website: http://health.state.ga.us/phil/admin/faq.asp

B. Standard Medical Records All current forms are located on the Georgia TB web site (www.health.state.ga.us/programs/tb)

1. LTBI Therapy

A standard medical record for the client on LTBI treatment includes the following:

TB Service Record

(Form 3121-R)

DOT Agreement for TB Treatment

(Form 603 DOT)

DOT Provider Agreement

(Form 604 DOT)

DOT record/DOPT Medication Sheet

(Form 3130)

Flow Sheet

(Form 3135)

Progress Notes

(Form 3573)

Consent/Treatment Plan

(Form 3609 LTBI)

Release of Information

(Form 5459)

2. Suspects/Cases

A standard medical record for a TB suspect includes the following:

TB Service Record

(Form 3121-R)

Contact Investigation

(Form 3126)

DOT Record

(Form 3130)

Georgia Tuberculosis Policy and Procedure Manual 2009

21

DOT Agreement for TB Treatment

(Form 603 DOT)

DOT Provider Agreement

(Form 604 DOT)

TB Flowsheet

(Form 3135)

Bacteriology

(Form 3143)

Progress Notes

(Form 3573)

Consent

(Form 3609 TB)

Treatment Plan

(Form 3144)

Release of Information

(Form 5459)

C. Recommended Form Usage Guide

This is available on the web site http://health.state.ga.us/programs/tb under the public health clinic forms section.

TB Program Forms Recommended Usage

Form Number Form Description

Reporting & Notification

3140

New TB Suspect Referral

3141

Initial Report on Patient with TB

3142 NTCA 32002

Followup Report on Patient with TB
Interjurisdictional Tuberculosis Notification Instructions Interjurisdictional Tuberculosis Notification Form Interjurisdictional Tuberculosis Followup Form

Report of Verified Case of Tuberculosis (RVCT) print pp. 13 Followup CDC 72.9A Report 1 print p. 4 Followup Report 2 print pp. 56

Revs Date
8/2006 8/2006 8/2006 03/2002 03/2002 05/2002
09/2008

3144 DPH04/ 328HW 3575
3609. LTBI

Legal
Active Tuberculosis (TB) Treatment Plan [English, Burmese, Chinese, Korean,
Spanish, Vietnamese]

01/2008

Medication Information [ English, Burmese, Chinese, Korean, Spanish, Vietnamese] 03/2008

Refusal of Care Form TB Program [English, Burmese, Chinese, Korean, Spanish,
Vietnamese]
Consent and Treatment Plan Latent TB Infection (LTBI) [English,
Burmese, Chinese, Korean, Spanish, Vietnamese]

03/2008 01/2008

Required
No No No
Yes Information Required in SENDSS
Yes Yes Yes Yes

Georgia Tuberculosis Policy and Procedure Manual 2009

22

3609. TB
603 DOT 604 DOT 5459
3121R 3126 3130 3135 TB/HIV

Consent to Treatment Active TB Case/Suspect [English, Burmese, Chinese,
Korean, Spanish, Vietnamese]
Directly Observed Therapy (DOT) Agreement for TB Treatment Directly Observed Therapy (DOT) Provider Agreement DHR Authorization for Release of Information
Case Management / Clinic
Tuberculosis Services Contact Investigation Report DOT Medication Sheet Tuberculosis Flowsheet TB / HIV Flowsheet

DPH 04 /324 MDRTB Flowsheet

2nd Line

Second Line Therapy Authorization Form

HAIN

HAIN Rapid TB Diagnostic & Resistance Submission Form

3143

Bacteriologic Examinations Record

3412HD

Georgia Public Health Laboratory TB Submission Form

3573

Progress Notes

Case Review Format
GA DPH TB Unit Form Rec. Use (Rev. 10/2009)

01/2008 Yes

10/2009 10/2009

Yes

04/2005 Yes

03/2009 03/2009 8/2006 8/2006 03/2009 03/2009 06/2008 06/2008 05/2008 12/2006
06/2008

Yes Yes Yes Yes Yes Yes Yes
Yes
As needed Yes

D. Retention of Medical Records

1. Cases It will be the responsibility of the Georgia Tuberculosis Section to maintain medical records on TB cases for at least twenty-one (21) years. Information should include name, date of birth, county, medications, drug susceptibility, chest x-ray reports and record of disposition.

2. Latent TB Infection Records of clients with LTBI should be kept by the county health department in a form that is compatible with local record retention policies for twenty-one (21) years after the client completes therapy or is closed for any reason.

3. Chest X-ray Films Records of chest x-ray films should be maintained according to the policy of the provider. The local or district health department will be responsible for documentation of the evaluation of the film (TB service records) and film locations.

Georgia Tuberculosis Policy and Procedure Manual 2009

23

VII. A.

TRANSMISSION AND PATHOGENESIS OF TUBERCULOSIS

Transmission

Mycobacterium tuberculosis is an organism that causes tuberculosis (TB). M. tuberculosis is sometimes called tubercle bacilli.

Mycobacteria can cause a variety of diseases. The mycobacteria that constitute the M. TB complex are M. tuberculosis, M. bovis, M.microti and M. africanum. Other mycobacteria are called nontuberculous mycobacteria (NTM, atypical, MOTT) because they do not spread from person-to-person. For more information on nontuberculous mycobacteria, refer to the appendix.

TB is spread from person-to-

Transmission

person through the air. Infectious TB disease

TB is caused by M. tuberculosis TB is spread by airborne particles that
contain M. tuberculosis, called droplet

(pulmonary and laryngeal) can be spread when a person coughs or sneezes.

nuclei

Droplet nuclei may be expelled when a

Tiny particles containing M.

person with infectious TB coughs or sneezes Close contacts are at the highest risk of becoming infected Transmission occurs from person with infectious disease (not LTBI)

tuberculosis may be expelled into the air. These particles, called droplet nuclei, are about 1 to 5 microns in diameter less than 1/5000 of an inch.

Droplet nuclei can be

suspended in the air for hours,

depending on the

environment. If another person inhales air that contains these droplet

nuclei, transmission may occur. Not everyone who is exposed to an

infectious TB client becomes infected with M. tuberculosis. The

probability that pulmonary or laryngeal TB will be transmitted depends on

several factors.

How infectious is the TB client? In what kind of environment did the exposure occur? How long did the exposure last? How susceptible is the contact?

The best way to stop transmission is to isolate the clients with infectious TB immediately and begin effective TB therapy. Infectiousness declines very rapidly after the appropriate therapy is started.

Georgia Tuberculosis Policy and Procedure Manual 2009

24

For contacts of persons with drug-resistant TB, infection rates seem to be similar to those of drug-susceptible TB. However, because they may have a poor response to treatment, clients with drug-resistant disease are often infectious for longer periods and have the potential to infect more contacts. HIV-infected persons with TB disease are not considered more infectious than non-HIV-infected persons with TB disease.

Extrapulmonary TB is rarely contagious; however, transmissions from extrapulmonary sites have been reported during aerosol-producing procedures such as autopsies and tissue irrigation.

The following are persons more likely to be exposed to or infected with TB:

Close contacts of persons known or suspected to have TB. Foreign-born persons from areas where TB is common. Residents and employees of high-risk congregate settings. Health care workers (HCWs) who serve high-risk clients. Medically underserved, low-income populations. High-risk racial or ethnic minority populations. Children exposed to adults in high-risk categories. Persons who abuse drugs, especially illicit/injected drugs.

B. Pathogenesis

Infection begins when droplet nuclei reach the alveolus.

When a person inhales air that contains infectious droplets, most of the larger droplets become lodged in the upper respiratory tract (the nose and throat) where infection is unlikely to develop. However, the droplet nuclei may reach the small air sacs of the lung (alveoli) where infection begins.

Initially, the tubercle bacilli multiply in the alveoli and a small number spread through the lymphatic channels to regional lymph nodes and then through the bloodstream to more distant sites. Bacilli may reach any part of the body. The areas TB disease are more likely to develop include the upper portion of the lungs, the kidneys, the brain and the bone. Within 2 to 10 weeks, the body's immune system usually intervenes, halting multiplication and preventing further spread. The immune system is the system of cells and tissue in the body that protect the body from foreign substances. The immune system does this by producing special cells that surround the tubercle bacilli. The cells form a hard shell that keeps the bacilli contained and under control. At this point, the person is said to have latent TB infection (LTBI).

Infection progresses to active TB disease when tubercle bacilli overcome the defenses of the immune system and begin to multiply. Infection can

Georgia Tuberculosis Policy and Procedure Manual 2009

25

progress to disease very quickly or many years after infection. In the United States, approximately 5% of persons who have been recently infected with M. tuberculosis will develop TB in the first year or two after infection and another 5% will develop disease later in their lives. In other words, approximately 10% of persons infected with M. tuberculosis will develop the disease at some point. The remaining 90% will remain infected but free of disease for the rest of their lives.

Some medical conditions increase the risk that TB infection will progress to disease. The risk may be approximately three times greater to more than 100 times greater for persons who have these conditions than for those who do not. Some of these conditions include:

HIV Infection Substance abuse (especially drug injection) Recent infection with M. tuberculosis (within the past 2 years) Chest radiograph findings suggestive of previous TB in a person
who received inadequate or no treatment. Diabetes mellitus Silicosis Prolonged corticosteroid therapy Other immunosuppressive therapy Cancer of the head and neck Hematological and reticuloendothelial diseases (e.g., leukemia and
Hodgkin's Disease) End-stage Renal Disease Intestinal bypass or gastrectomy Chronic malabsorption syndrome Low body weight (10% or more below ideal)

HIV Infection and TB
Persons co-infected with HIV and M. tuberculosis are at very high risk of developing TB disease.

In an HIV-infected person, TB disease can develop in either of two ways. A person with TB infection who becomes infected with HIV can rapidly develop TB disease due to a weakened immune system. A person with HIV infection who becomes infected with M. tuberculosis can also rapidly develop TB disease.

TB disease most commonly affects the lungs. Approximately 85% of all TB cases are pulmonary. Clients with pulmonary TB usually have a cough and an abnormal chest radiograph and should be considered infectious.

Georgia Tuberculosis Policy and Procedure Manual 2009

Common Sites of TB Disease
Lungs (85% of all cases) Pleura Central nervous system Lymphatic system Genitourinary system Bones and joints Disseminated (miliary TB)

26
However, TB is a systemic disease and may also occur as a pleural effusion; in the central nervous, lymphatic, or genitourinary systems; in the bones and joints; or as disseminated disease (military TB).

Pulmonary and extrapulmonary TB are among the conditions included in the 1993 AIDS surveillance case definition. Any HIV-infected person with a diagnosis of TB disease should be reported as having TB and AIDS.

Georgia Tuberculosis Policy and Procedure Manual 2009

27

VIII.

DIAGNOSIS OF TUBERCULOSIS DISEASE

Before clinicians can diagnose TB disease in a client, they must think of the possibility of TB when they see a client with symptoms of TB or abnormal chest xray findings.

Anyone with symptoms of TB should be evaluated for TB disease. Anyone found to have a positive tuberculin skin test reaction should be evaluated for TB disease.

A complete medical evaluation for the diagnosis of TB should include the following:

Medical History Physical Assessment Mantoux Tuberculin Skin Test or QuantiFERON Test (QFT) Chest Radiograph Bacteriologic/Histologic Examinations

A. Medical History

A medical history is the part of a client's life history that is important for diagnosing and treating the client's medical condition. It includes social, family, psychological, medical and occupational information about the client. It should also contain an exposure history. The nurse/clinician should ask whether the client has:

Been exposed to a person who has infectious TB Symptoms of TB disease Had LTBI or TB disease previously Risk factors for developing TB disease

Clinicians should suspect TB disease in clients with any of these factors.

Some people may have been exposed to TB in the distant past, when they were children. Others may have been exposed more recently.

Exposure to TB. One important part of the medical history is asking the client about his or her exposure to TB. Clients should be asked whether they have spent time with someone who had infectious TB. Some people may have been exposed to TB in the distant past, when they were children. Others may have been exposed more recently.

Anyone who has been exposed to TB may have TB infection. Some people become infected with M. tuberculosis without knowing that they were exposed. The risk of being exposed to TB is higher for some occupations

Georgia Tuberculosis Policy and Procedure Manual 2009

28
(for example, health care workers) and in some residential facilities (for example, nursing homes or correctional facilities).

Symptoms of TB disease. People with TB disease may People with TB disease may or may or may not have symptoms. not have symptoms. However, most
clients with TB disease have one or more symptoms that lead them to seek medical care. Occasionally, TB is discovered during a medical examination for an unrelated condition (for example, when a client is given a chest x-ray before undergoing surgery). Usually, when clients do have symptoms, the symptoms have developed gradually and they have been present for weeks or even months.
Pulmonary TB disease usually causes one or more of the following symptoms:
Coughing (for longer than 2-3 weeks that does not respond to treatment) Pain in the chest when breathing or coughing Coughing up sputum (phlegm from deep in the lungs) or blood
The general symptoms of TB disease (pulmonary and extrapulmonary) include:
Weight loss Fatigue Malaise Fever Night sweats
The symptoms of extrapulmonary TB disease depend on the part of the body that is affected by the disease. TB of the spine may cause pain in the back; TB of the kidney may cause blood in the urine. Other diseases may cause all of these symptoms, but they should prompt the clinician to suspect TB disease.

The clinician should ask the client whether he or she has ever been diagnosed with or treated for TB infection or disease.

Previous TB infection or TB disease. During the medical history, the clinician should ask the client whether he or she has ever been diagnosed with or treated for LTBI or disease.

Georgia Tuberculosis Policy and Procedure Manual 2009

29
Clients known to have a positive skin test reaction probably have LTBI. If they were infected within the last 2 years, they are at high-risk for TB disease. Clients who have had TB disease in the past should be asked when they had the disease and how the disease was treated. If the regimen prescribed was inadequate or if the client did not follow the recommended treatment, TB may recur, and may be resistant to one or more of the drugs used.
Risk factors for developing TB disease. The following conditions appear to increase the risk that TB infection will progress to disease:
HIV infection Substance abuse (especially drug injection) Recent TB infection within the past 2 years Chest x-ray findings suggestive of previous TB Diabetes mellitus Silicosis Prolonged therapy with corticosteroid Immunosuppressive therapy Certain types of cancer (e.g., leukemia, Hodgkin's disease, cancer of the
head and neck) Severe kidney disease Certain intestinal conditions Low body weight (10% or more below ideal)
Clinicians should determine whether clients have any of these conditions. In particular, HIV infection greatly increases the risk that TB infection will progress to TB disease.
B. Physical Assessment
A physical assessment is an essential part of the evaluation of any client. A directed and pertinent physical assessment should be done based on the client's history. It cannot confirm or rule out TB disease but it can provide valuable information about the client's overall condition and other factors that may affect how TB disease is treated, if it is diagnosed. A history and physical of record from referring physicians or hospitals are acceptable in health departments not employing a full-time TB physician. Children identified with symptoms suggestive of TB or an abnormal chest x-ray must be examined by a physician if not directly referred from a hospital or physician.
The purposes of the physical assessment of an adult or child TB suspect or case are:
Georgia Tuberculosis Policy and Procedure Manual 2009

30
To establish how ill the person is, both to determine if there is a need for hospitalization and as a baseline for documenting clinical improvement with treatment.
To determine the extent of disease by searching for disseminated disease and, again, as a baseline for documenting clinical improvement with treatment.
The assessment can include:
Vital signs temperature, pulse rate, blood pressure, respiratory rate and weight. If the client appears ill, postural vital signs, i.e., comparing the pulse rate and blood pressure while in the sitting and then the standing position, can indicate volume depletion.
The client's mental status should be assessed for signs of decreased alertness, which raises the question of central nervous system involvement.
Cervical lymph nodes should be examined by palpation. The lung fields should be percussed to determine if a pleural
effusion is present, as well as auscultated for areas of consolidation. For adults, signs of active liver disease should be noted, including
scleral icterus and jaundice. If either sign is present, the liver should be palpated to determine if it is enlarged. Evaluation of symptoms Review of systems for gross abnormalities.
C. Mantoux Tuberculin Skin Test (TST) or QuantiFERON-TB Test (QFT)*
1. The TST is a diagnostic aid that uses tuberculin (PPD solution) as the test solution. Tuberculin is a protein derived from tubercle bacilli that have been killed by heating. In most people with LTBI, the immune system will cause a reaction to the tuberculin. However, it is estimated that 20% of persons with TB disease will not react to the tuberculin skin test initially. Persons with symptoms suggestive of TB should always receive an evaluation for TB disease regardless of their skin test results. For persons entering the health department with symptoms of TB, the clinician should not wait on the TST results before beginning other diagnostic tests. All persons with significant reactions to the TST should be referred for a chest x-ray to determine presence of lung abnormalities.
Although the skin test is not perfect, it is a useful tool for:
Examining a person who has been exposed to someone who has TB disease to determine if they have LTBI
Examining a person with symptoms of TB
Georgia Tuberculosis Policy and Procedure Manual 2009

31
Screening groups of persons at risk for LTBI
Persons who should receive a tuberculin skin test (unless there is documentation of a previous positive TST recorded in mm induration)
Anyone with symptoms of tuberculosis Contacts to pulmonary and extrapulmonary tuberculosis cases Persons infected by HIV Low income groups with poor access to health care Foreign born persons from areas of the world where TB is common Substance abusers Persons with certain medical conditions Children exposed to adults in high-risk categories Persons who may have occupational exposure. e.g. health care
workers High-risk racial or ethnic minority population. The residents and employees of high-risk congregate settings.
There are different types of tuberculin skin tests available. However, the preferred skin test is the Mantoux tuberculin skin test. Multiple puncture tests (e.g., TINE test and Heaf test) should not be used because the technique is not standardized and creates problems in reading results. Any person presenting to the health department with either a negative or positive reaction to a multiple puncture test should have a Mantoux skin test.
Prior to the administration of a TST, the patient's risk factors and cut off point should be determined and recorded.
2. Two-Step Testing and the Booster Phenomenon
In certain persons with LTBI, the delayed-type hypersensitivity (DTH) responsible for TST reactions wanes over time. Repeated TST can elicit a reaction called boosting in which an initial TST result is negative, but a subsequent TST result is positive. For example, a TST administered years after infection with M. tuberculosis can produce a false-negative result. This TST might stimulate (or boost) the person's ability to react to tuberculin, resulting in a positive result to a subsequent test (including the second step of a two-step procedure). With serial testing, a boosted reaction on a subsequent TST might be misinterpreted as a newly acquired infection, compared with the false-negative result from the initial TST. Misinterpretation of a boosted reaction as a new infection with M. tuberculosis or TST conversion might prompt unnecessary investigations to find the source case, unnecessary treatment for the person tested, and unnecessary testing of other HCWs.
Georgia Tuberculosis Policy and Procedure Manual 2009

32
The booster phenomenon can occur in anyone, but it is more likely to occur in older persons, persons with remote infection with M. tuberculosis (i.e., infected years ago), persons infected with Nontuberculous mycobacteria (NTM), and persons with previous BCG vaccination.
All newly employed health care workers (HCWs) who will be screened with TST should receive baseline two-step TST upon hire, unless they have documentation of either a positive TST result or treatment for LTBI or TB disease. Any setting might have HCWs at risk for boosting, and a rate of boosting even as low as 1% can result in unnecessary investigation of transmission. Therefore, two-step TSTs are needed to establish a baseline for persons who will receive serial TST (e.g., residents or staff of correctional facilities or LTCFs). This procedure is especially important for settings that are classified as low risk where testing is indicated only upon exposure. A reliable baseline test result is necessary to detect health-care--associated transmission of M. tuberculosis.
3. Administration of Two-Step Testing
Administer the first TST. If the result of the first TST is positive, consider the person
infected and do not give a second TST. If the result of the first TST is negative, give a second TST one
to three weeks later. If the result of the second TST is negative, consider the person
uninfected. If the result of the second TST is positive, this probably
indicates a boosted reaction from the past TB infection. If a person had a positive reaction to either TST, refer for a chest
x-ray.
4. Causes of False Negative/False Positive TST False-positive reactions may be caused by:
o Nontuberculous mycobacteria o BCG vaccination o Technique reading erythema, not induration
False-negative reactions may be caused by:
o Anergy (the inability to react to skin tests due to a weakened immune system)
o Recent TB infection (It takes two to ten weeks after TB infection for the body's immune system to respond to
Georgia Tuberculosis Policy and Procedure Manual 2009

33
TST. A skin test during this period of immune activity may be negative.) o Very young age (< 6 months old) o Live-virus vaccination o Overwhelming TB disease
5. Anergy
Persons having impaired immune systems cannot react to tuberculin even if they are infected with TB. This inability to react to the skin test due a weakened immune system is a condition known as anergy. If anergy is suspected, it is recommended further evaluation with chest x-ray and sputum collection be done in symptomatic patients.
Anergy can be assessed to some degree with skin test antigens such as tetanus, mumps and candida (anergy testing). Most, but not all, healthy people will have a skin test reaction to one or more of these substances. Unfortunately, the response to anergy testing is unreliable and may change from one testing period to the next. The TB Program does not recommend the use of anergy testing and the state program does not supply skin test antigens. The decision to conduct anergy testing is left to local medical staff.
Consider anergy in persons with no TST reaction if:
HIV infected Overwhelming TB diseases Severe febrile illness Viral infections Recent live-virus vaccinations Immunosuppressive therapy
6. Definition of a TST Conversion
A tuberculin skin test conversion is defined as an increase of > 10 mm of induration within a two year period, regardless of age.
7. TST and Live Virus Vaccinations
There is no evidence that suggests live virus vaccines (MMR, Polio) exacerbate tuberculosis
A TST can be administered the SAME DAY as a live vaccine A person who has had a recent live virus should wait at least four to
six weeks before having a tuberculin skin test.
Georgia Tuberculosis Policy and Procedure Manual 2009

34
8. TST During Pregnancy
There are no contraindications to TST during pregnancy. Studies have demonstrated that tuberculin skin testing is considered valid and safe throughout pregnancy. It is recommended that pregnant women who are at high-risk for TB, such as close contacts to a person with TB disease, be evaluated with a TST and chest-x-ray.
9. TST recommendations for infants, children and adolescents
Infants with TB infection may be anergic as late as six month of age. However, it is recommended that infants who are close contacts to a person with tuberculosis disease be evaluated with a tuberculin skin test and chest x-ray. If the TST is negative (< 5 mm) and the chest x-ray is normal, the TST should be repeated again 8-10 weeks following the initial TST and at six months of age. The infant should receive LTBI therapy even if the TST and Chest X-rays are negative. LTBI therapy should be discontinued if the TST at six months is negative, provided it has been at least ten weeks since the infant was last exposed to infectious TB.
Children for whom immediate TST is indicated: Contacts of people with confirmed or suspected contagious tuberculosis (contact investigation) Children with radiographic or clinical findings suggesting tuberculosis disease Children immigrating from endemic countries (e.g., Asia, Middle East, Africa, Latin America) Children with travel histories to endemic countries and/or significant contact with indigenous people from such countries
Children who should have annual TST2: Children infected with HIV Incarcerated adolescents
Some experts recommend that children should be tested every 2-3 years2: Children with ongoing exposure to the following people: HIV infected people, homeless people, residents of nursing homes, institutionalized adolescents or adults, users of illicit drug, incarcerated adolescents or adults, and migrant farm workers; foster children with exposure to adults in the preceding high-risk groups are included
2 Initial TST is at the time of diagnosis or circumstance, beginning at 3 months of age.
Georgia Tuberculosis Policy and Procedure Manual 2009

35
Some experts recommend that children should be considered for TST at 4-6 and 11-16 years of age: Children whose parents immigrated (with unknown TST status) from regions of the world with high prevalence of tuberculosis; continued potential exposure by travel to the endemic areas and/or household contact with people from the endemic areas (with unknown TST status) should be an indication for a repeated TST
Children at increased risk of progression of infection to disease: Children with other medical conditions, including diabetes mellitus, chronic renal failure, malnutrition, and congenital or acquired immunodeficiencies deserve special consideration. Without recent exposure, these people are not at increased risk of acquiring tuberculosis infection. Underlying immune deficiencies associated with these conditions theoretically would enhance the possibility for progression to severe disease. Initial histories of potential exposure to tuberculosis should be included for all of these patients. If these histories or local epidemiologic factors suggest a possibility of exposure, immediate and periodic TST should be considered. An initial TST should be performed before initiation of immunosuppressive therapy, including prolonged steroid administration, for any child with an underlying condition that necessitates immunosuppressive therapy.
According the American Academy of Pediatrics guidelines, all children with a positive TST should have the following performed:
A history o to determine possible exposure (source case identification) o the presence of symptoms related to possible TB o other medical history that could signal increased risk of progression to TB o factors relating to adherence
A targeted physical exam to look for signs of TB (including examination of lymph nodes A chest x-ray (Posterior/Anterior and Lateral) because the lateral view has higher sensitivity for detecting hilar lymphadenopathy Baseline laboratory tests are not always indicated in children unless there are existing medical conditions that increase the risk for hepatotoxicity, but they may be done under the direction of the treating physician
10. TST and BCG Vaccinations
BCG (Bacillus Calmette-Guerin) is a vaccine for TB disease that is used in many countries. A history of BCG vaccination is NOT A RELIABLE WAY to determine if a positive TST is caused by BCG
Georgia Tuberculosis Policy and Procedure Manual 2009

36
vaccination or by true TB infection. When interpreting TST results, disregard the history of BCG.
The reaction is more likely to be due to TB infection if: The reaction is large (10 mm or more induration) The person is a contact to someone with infectious TB (especially if
the case has infected others) The person's family has a history of TB disease The person comes from a country with a high prevalence of TB The person had the BCG vaccine a long time ago (vaccination induced
reactions wane over time and are unlikely to persist for more than ten years)
*QuantiFERON-TB (QFT) Testing is an in vitro whole blood lab test used as an aid in diagnosing infection with M.tuberculosis. The QFT test is not yet available statewide. As the test becomes available and guidelines and recommendations are published, the information will be provided as an appendix to the current manual. Please direct questions related to QuantiFERON-TB Testing to the state office. At present, either the TST OR the QFT should be used as a diagnostic aid; it is not recommended that these tests be used interchangeably. Do not use QFT to confirm a positive or negative TST.
D. Chest X-rays
The chest x-ray is a useful tool in assisting in the diagnosis of TB disease because about 85% of TB clients have pulmonary TB. Usually, when a person has TB disease in the lungs, the chest x-ray appears abnormal. It may show infiltrates (collections of fluid and cells in the tissues of the lung) or cavities (hollow spaces within the lung that may contain many tubercle bacilli).
Posterior-anterior and lateral views of the chest are the standard radiograph needed for the detection and description of chest abnormalities. In some instances, other views (e.g. lateral, lordotic) or additional studies (e.g. CT scans) may be necessary. A lead apron should cover the entire abdomen of a pregnant woman during a chest x-ray.
In pulmonary TB, chest radiograph abnormalities often occur in the apical and posterior segments of the upper lobe or in the superior segments of the lower lobe. However, lesions may appear anywhere in the lungs and may differ in size, shape, density and cavitation, especially in HIV-infected and other immunosuppressed persons.
All patients with suspected or diagnosed extra-pulmonary TB disease should have a chest x-ray to rule out co-existing pulmonary disease. A person with medical risks who is a contact to an individual with active TB should have a chest x-ray regardless of TST results.
Georgia Tuberculosis Policy and Procedure Manual 2009

37
Individuals with a newly positive TST should have a chest x-ray to assure they do not have active TB disease. After an initial negative chest x-ray, repeat chest x-rays are not necessary unless signs or symptoms of TB disease develop or a clinician recommends a repeat chest x-ray. Persons with a positive TST should be educated about the signs and symptoms of TB disease with instructions to consult their health care provider should symptoms occur. A sample TB symptom screen if available on http://health.state.ga.us/tb/publications.asp in TB Assessments.
Abnormalities on chest radiographs may be suggestive of, but are never diagnostic of TB. However, chest radiographs may be used to rule out the possibility of pulmonary TB in a person who has a positive reaction to the tuberculin skin test and no symptoms of disease. A variety of illnesses may produce abnormalities whose appearance on a chest x-ray resembles TB. Although an abnormality on a chest x-ray may lead a clinician to suspect TB, only a bacteriologic culture that is positive for M. tuberculosis proves that a client has TB disease. Moreover, a chest x-ray cannot detect TB infection.
E. Bacteriologic and Histologic Examination
This is the examination and the culture (growth) of clinical specimens (e.g. sputum or urine) in the laboratory. The bacteriologic examination has four parts:
Obtaining a specimen Examining the specimen under a microscope Culturing the specimen Performing drug susceptibility testing on positive cultures
To establish the diagnosis of extrapulmonary TB, a variety of specimens including pleural fluid, peritoneal fluid, pleural and peritoneal biopsy specimens, lymph node tissue, bone marrow, bone, blood, urine, brain and cerebrospinal fluid may need to be obtained for mycobacterial culture. Specimens must be examined microscopically, but the inability to demonstrate Acid Fast Bacilli (AFB) and the absence of granuloma formation does not exclude the diagnosis of TB.
Acid Fast Bacilli Smear
After a clinical specimen undergoes a decontamination and concentration procedure, it is smeared onto a glass slide and stained with a dye. This is
Georgia Tuberculosis Policy and Procedure Manual 2009

38
called a smear. The laboratory personnel use a microscope to examine the smear for acid-fast bacilli (AFB).
Detection of AFB in stained smears examined microscopically may provide the first bacteriologic clue of TB.
Smear examination is a quick and easy procedure; results should be available within 24 hours of the specimen arrival time in the laboratory. However, smear examination permits only the presumptive diagnosis of TB because the AFB on a smear may be mycobacteria other than M. tuberculosis. Furthermore, many TB clients have negative AFB smears.
It is important to note that a negative smear does not rule out the possibility of TB because there can be AFB in the smear that were not seen. Negative smears can also occur when the specimen consists of saliva rather than pulmonary exudates.
Cultures
When M. tuberculosis is identified in a client's culture, the client is said to have a positive culture for M. tuberculosis. A positive culture for M. tuberculosis confirms a diagnosis. Culture examinations should be done on all specimens, regardless of AFB smear results. When a liquid medium such as the MGIT (mycobacteria growth indicator tube) is inoculated for growth and rapid methods are used for species identification, culture results are sometimes available within 10 to 14 days of specimen inoculation date. If a solid medium and conventional biochemical tests are used, the isolation of the organism can take 6 to 12 weeks.
Follow-up bacteriologic examinations are important for assessing the client's infectiousness and response to therapy. At a minimum, one sputum specimen should be obtained at weekly intervals until three consecutive negative smears are obtained. Subsequently, a sputum specimen should be obtained monthly throughout treatment. It is particularly important to obtain a sputum specimen for smear/culture examination 2 months after initiation of treatment to identify clients at high-risk for adverse outcomes (treatment failure or relapse). Refer to district TB Coordinator and contract physician if culture remains positive after two months of treatment. If a client cannot produce a specimen this should be documented in the medical record.
Laboratories should report positive smears and positive cultures within 24 hours by telephone or facsimile to the primary health care provider. Follow-up results may be reported by mail. It is the responsibility of the primary health care provider to promptly report all suspected or confirmed
Georgia Tuberculosis Policy and Procedure Manual 2009

39

cases of TB to the health department so that a contact investigation can be initiated as quickly as possible.
COMPARISON OF SPUTUM SMEARS AND CULTURES

Procedure Basis Average time report available Significance of negative report
Significance of positive report

SMEAR Microscopic visualization of acid-fast bacilli 1- 4 days

CULTURE Tubercle bacilli grown on culture media in incubator 2 12 weeks

TB not ruled out, (culture may still be positive). Client less likely to be infectious.
If M. tuberculosis, client likely to be infectious. Could also be due to non-tuberculosis mycobacteria.

No live tubercle bacilli found in the specimens. (Can be in other specimens and/or in the client). Does not rule out TB. Constitutes only proof of diagnosis of tuberculosis.

Rapid Diagnostic Tests (Molecular Tests)

There are currently two nucleic acid amplification (NAA) assays available for commercial use in the United States to rapidly diagnose TB from sputum smears:
MTD (amplified Mycobacterium tuberculosis direct test) PCR (Polymerase Chain Reaction) The Georgia Public Health Lab and the Grady lab currently perform MTD on all first time positive smears and will perform MTD on smear negative specimens upon request.

The tests are roughly equivalent in clinical use. Each test accurately diagnoses nearly every case of sputum smear-positive pulmonary TB and each diagnoses 50% to 80% of the cases of smear- negative, culture-positive TB. If the NAA assays are used to ask "Does my patient have active pulmonary TB?", the answer will be correct 92-95% of the time compared with 80% of the time if smears are used. This will be true as long as the patient has no history of recently treated TB, as the NAA assays may be less accurate in this case.

MTD testing is currently approved for respiratory specimens. It has not been validated in non-respiratory specimens. The MTD test is intended for use with at least one specimen from a patient showing signs and symptoms consistent with active pulmonary tuberculosis for whom a diagnosis of TB is being considered but has not yet been established and for whom the test result would alter case management or TB control activities, such as contact investigation. Patients who are suspected of having pulmonary TB based on clinical evaluation and who have

Georgia Tuberculosis Policy and Procedure Manual 2009

40

received no antituberculosis therapy, less than 7 days of such therapy or have not received therapy in the last 12 months may be evaluated with this test.

CDC is now recommending that NAA testing be performed on all first time smear positive specimens and smear negative specimens as a standard of practice in the United States

MTD Test Interpretation Guidelines

If the smear and the MTD results are both positive, presume the patient has TB and begin anti-TB treatment while awaiting culture results
If the smear is negative but the MTD is positive, the patient can be presumed to have TB.
If the smear is positive and the MTD is negative, the sputum should be tested for inhibitors and the MTD repeated. If inhibitors are not detected, the patient is presumed to have nontuberculous mycobacteria.
If both smear and MTD are negative, an additional specimen should be tested by assay. This does not rule out TB and should be culture confirmed
Always rely on clinical judgment. Ultimately, definitive diagnosis rests on culture results and response to
therapy.

Drug Susceptibility

For all clients, the initial M. tuberculosis isolate should be tested for drug susceptibility. It is crucial to identify drug resistance as early as possible in order to ensure appropriate treatment. Drug susceptibility patterns should be repeated for clients who do not respond adequately or who have positive culture results after two months of therapy. Susceptibility results from laboratories should be promptly forwarded to the health department. The state lab routinely initiates drug susceptibility testing on the initial isolate and automatically repeats the susceptibility testing every 3 months for as long as the client's cultures remain MTB positive. Further susceptibility testing must be requested.

Drug Susceptibility Testing
. For all clients, do drug susceptibility testing on initial M. tuberculosis isolate . Repeat for clients who do not respond to therapy or who have positive cultures after two months of therapy . Forward susceptibility results promptly to the health department

The MGIT 960 susceptibility method, which uses liquid media, is faster than the conventional agar proportion method for determining susceptibility to first line TB medications. Results are usually available 5-12 days after the susceptibility testing is started. Conventional methods, which use solid media for growth, can take as long as 21 days after inoculation.

Georgia Tuberculosis Policy and Procedure Manual 2009

41

Persons at an increased risk for drug resistance include: Persons who have a history of treatment with TB drugs Contacts of persons with drug-resistant TB Foreign-born persons from high prevalent drug-resistant areas Persons whose smears or cultures remain positive despite two months of
TB treatment Persons who have received inadequate treatment regimens for > 2
weeks

Sputum Collection

Microbiologic examination of sputum material raised from the lungs and bronchi during deep coughing is important in the evaluation and diagnosis of pulmonary tuberculosis. Sputum is a thick, sticky pulmonary exudate and must be distinguished from the saliva or postnasal discharge that it may accompany.

Collect specimen early in the morning soon after awaking and before eating or using tobacco. All sputum should be collected outdoors or in an approved sputum collection booth/chamber. Instruct the person to rinse their mouth with plain tap water to remove any food particles, snuff or tobacco. Do not use mouthwash or toothpaste before collecting sputum.

For the best results, the preferred amount of sputum needed is 8 cc in a sterile container. The specimen should be refrigerated if not mailed immediately. This practice will reduce the number of specimens labeled as contaminated. Mail the specimen to the Georgia DHR Laboratory in the pre-addressed container or deliver it to the local laboratory on the morning of collection. The laboratory request must be complete, including the date of collection, and the lab request should be wrapped around the metal can. The client's name must be on the specimen container or the lab cannot perform testing on the specimen. The name on the tube must be matched exactly to the name on the lab slip.

Certified sputum means that the client collects sputum in the presence of a member of the health department. Write "Certified Sputum" on the label.

Additional Specimen Collection Procedures

1. Induced Sputum
For an induced sputum sample, the client inhales a saline mist, causing him or her to cough deeply.

If a client cannot cough up sputum on his or her own, other techniques can be used to obtain a specimen. An induced sputum sample can be

Georgia Tuberculosis Policy and Procedure Manual 2009

42

obtained by having the client inhale a saline (salt water) mist, which causes the client to cough deeply. Induced specimens are often clear and watery, so they should be labeled induced specimen so that they will not be confused with saliva (laboratories will not accept saliva as a specimen).

1. Bronchoscopy

A bronchoscopy is done to obtain pulmonary secretions or lung tissue.

Another procedure, bronchoscopy, can be used to obtain pulmonary secretions or lung tissue. In this procedure, an instrument called a bronchoscope is passed through the mouth

directly into the diseased portion of the lung

and some sputum or lung tissue is removed. Bronchoscopy should be used

only when clients cannot cough up sputum on their own and an induced

specimen cannot be obtained.

2. Gastric Washing

Gastric washings involve inserting a

For gastric washing, a tube is inserted through the client's nose and passed into the stomach to collect a sample of sputum that has been coughed into the throat and then swallowed.

tube through the client's nose and passing it into the stomach. The purpose is to get a sample of sputum that has been coughed into the throat and then swallowed. Gastric washings are done in the morning because clients usually swallow sputum during the night. This procedure is used

when clients cannot cough up sputum

on their own, induced specimens cannot be obtained, and a bronchoscopy

cannot be done. However, gastric washings are often used for obtaining

sputum from children. Most children produce little or no sputum when they

cough.

It is very important for health care workers to use precautions to control the spread of tubercle bacilli during these procedures and any other procedures that may cause persons who have pulmonary TB disease to cough.

3. Other Specimen(s) Urine
The client should not be receiving broad-spectrum antibiotics at the time of collection because the antibiotics may destroy mycobacteria in urine.

Collection of urine culture. The first morning midstream specimen is preferred. Multiple specimens are

Georgia Tuberculosis Policy and Procedure Manual 2009

43
advised, to demonstrate the presence of mycobacteria. The client should not be receiving broad-spectrum antibiotics at the time of collection because the antibiotics may destroy mycobacteria in urine. Do not use parts of the gastric lavage outfits to collect and mail urine specimens for smear and culture. Order special containers from:
Georgia Public Health Laboratory Laboratory Supply 1749 Clairmont Road Decatur, Georgia 30033 Phone: (404) 327-7900
Do not order more than one or two containers for each client at any one time. After the proper containers are received from the laboratory, follow instructions for collecting the urine. Instructions: Complete the laboratory slip, giving all information such as name, address, etc., and type of testing desired--smear or culture or both. Wrap this slip around the bottle of urine and secure with a rubber band. Place the bottle of urine in the mailing container. Collect and mail specimen during first three (3) days of any week. [Mail from Post Office. Clients should NOT put specimen in street mailing boxes].
F.Nontuberculous Mycobacterium (NTM)
Mycobacteria other than M. tuberculosis are found throughout the environment. Nontuberculous mycobacteria can occasionally be agents in pulmonary or extra-pulmonary disease. Although the diseases produced by NTM may appear clinically similar to active tuberculosis, they can be differentiated by bacteriologic methods. Person to person transmission of NTM does not normally occur.
A physician familiar with the client's clinical picture must determine the relevance of NTM to the client's disease process. Once M. tuberculosis has been ruled out, the client should be referred to a private clinician for evaluation. The Georgia TB Program does not report, supply medication or manage disease caused by NTM.
Although M. tuberculosis is by far the most important human pathogen, numerous other species of mycobateria can cause disease in humans. Many mycobaterial species in addition to M. tuberculosis have been recognized in the laboratory for many years, but their potential as human pathogens was not demonstrated until 1951. A great problem in understanding this heterogeneous group of organisms was the lack of a workable classification system. They differ from M. tuberculosis, however, in terms of their rate of growth, colonial morphology, pigment production, biochemical reactivity, and pathogenicity. It is therefore best to refer to them as nontuberculous
Georgia Tuberculosis Policy and Procedure Manual 2009

44
mycobacteria (NTM) or atypical mycobacteria. They have also been called mycobacteria other than tuberculosis (MOTT).
Unlike M. tuberculosis, which is highly adapted to humans, the nontuberculos mycobateria are widely distributed in the animal kingdom and in nature. The epidemiology of these organisms is not well understood, but person-to-person transmission has never been demonstrated; human infection probably results from inhalation or ingestion of bacilli from the environment. Some so-called atypical mycobateria are concentrated in specific geographic regions, such as M. kansasii in the urban Midwest and MAC in the Southeast. Other atypical species, such as M. scrofulaceum and M. marium, are more widespread. Infections caused by nontuberculous mycobateria appear to be increasing, largely, but not exclusively, because of those produced by M. avium complex in AIDS patients.
Despite the facts that nearly three times more people have been infected with these atypical organisms than with M. tuberculosis, no more than 1% to 5% of all clinical mycobaterial infections are caused by nontuberculous mycobateria because of their much lower virulence. In fact, the most common problem is determining whether the laboratory isolation of an atypical mycobacterium is of clinical significance. One clue may be the species of Mycobacterium isolated. Many of these organisms can cause human disease, but others are nonpathogens and may even be laboratory contaminants. Criteria for the diagnosis of infection by an atypical Mycobacterium include repeated isolation of a potentially pathogenic species, the absence of other pathogens, and a compatible clinical, radiologic, or pathological picture.
Key points to remember include: 1. Nontuberculous mycobateria are not known to be transmitted
from human to human. 2. Because of this, nontuberculous mycobateria are not considered
a public health risk and are not generally treated by the health department. 3. Nontuberculous mycobateria are found in the environment (water, soil, etc.)
Georgia Tuberculosis Policy and Procedure Manual 2009

45
CLASSIFICATIONS OF THE NON-TUBERCULOUS MYCOBACTERIA RECOVERED FROM HUMANS

Clinical Disease
Pulmonary

Common Etiologic Species M. avium complex

M. kansasii M. chelonae Subspecies abscessus
M. xenopi

M. avium Lymphadenitis complex
M. scrofulaceum

Cutaneous

M. marinum M. fortuitum (all three bivirants)

Growth Rate
Slow (>7 days)
Slow Rapid (< 7 days) Slow
Slow
Slow
Rapid Rapid

Morphologic Features *
Usually not pigmented Photochromogen; often large and headed on acid fact bacilli smear

Unusual Etiologic Species
M. simise

Not pigmented Pigmented
Usually not pigmented
Scotochromogen Photochromogen; requires low temperatures (28 to 30) for isolation

M. szulgai M. maimoense M. fortuitum (all three bivirants) M. chelonae Subspecies chelonae M. fortuitum (all three bivirants) M. chelonae (both species)
M. kansasii

Not pigmented

M. avium complex

Georgia Tuberculosis Policy and Procedure Manual 2009

46

Clinical Disease
Disseminated

Common Etiologic Species M. chelonae (both species)

Growth Rate
Rapid

M. ulcerans Slow

M. avium complex

Slow

M. kansasii Slow M. chelonae (both species) Slow

M. haemophilium Rapid

Morphologic Features *
Not pigmented Usually a scotochromogen; requires low temperatures for isolation Isolates from clients with AIDS, usually pigmented (80%)
Photochromogen

Unusual Etiologic Species M. kansasii
M. smegmatis
M. fortuitum (all three bivirants)

Not pigmented
Not pigmented; requires hemin, often needs low temperatures and CO2 to grow

M. xenopi

Georgia Tuberculosis Policy and Procedure Manual 2009

47
IX. TREATMENT OF TB DISEASE
A. Pulmonary Disease
The Georgia Tuberculosis Program follows the most current CDC/ATS/IDSA treatment recommendations. Four drugs (INH, RIF, PZA, EMB) should be included in the initial treatment phase until drug susceptibility results are obtained. Once the patient is known to be susceptible to the drugs used during the initial treatment phase (approximately two months), begin the continuation phase with two drugs (INH, RIF) for four months. The patient should be monitored at least monthly in the clinic. The standard of care for all TB cases/suspects in Georgia is Directly Observed Therapy (DOT).
B. Extra Pulmonary Tuberculosis Disease
The Georgia Tuberculosis Program follows the most current ATS/CDC/IDSA treatment recommendations for treatment of extrapulmonary TB. Drug regimens used in the treatment of pulmonary TB in adults and children are also effective in extra-pulmonary disease.
C. Multi-Drug Resistant Tuberculosis (MDR-TB, XDR-TB)
MDR-TB is defined as tuberculosis with resistance to INH and RIF but may include resistance to other drugs as well. MDR-TB is difficult to treat. Therefore, treatment recommendations should be made in consultation with persons experienced in drug-resistant TB management. Treatment must be individualized, prolonged, and based on medication history as well as drug susceptibility results. Regimens are often 24 months in duration. Clinicians should consult with the TB Program before initiating treatment. Secondline drugs are provided by the state TB unit. Authorization must be obtained prior to initiating therapy.
The most recent definition of extensively drug-resistant TB (XDR-TB) according to CDC is disease caused by M. tuberculosis that is resistant to at least isoniazid and rifampin among first-line anti-TB drugs, resistance to any fluoroquinolone, and resistance to at least one second-line injectable drug (amikacin, capreomycin or kanamycin). As with MDR-TB, clinicians should consult with the TB Program before initiating treatment.
MDR flow sheet is available on the TB web site (www.health.state.ga.us/programs/tb) in the Public Health Clinic Forms section. The flow sheet is a valuable aid in case managing an MDR patient as medication history, not dose counting, is used to determine ongoing medical management. Dose counting is only valid for standardized regimens.
Georgia Tuberculosis Policy and Procedure Manual 2009

48
D. Guidelines for the Treatment of Tuberculosis and HIV/AIDS
Management of HIV-related TB disease is complex. The clinical and public health consequences associated with the failure of treatment are serious. Whenever possible, the care for HIV-related TB should be provided by or in consultation with the experts in the management of both TB and HIV disease. Team communication, documentation and follow-up are essential.
The TB/HIV flow sheet is available on the TB web site (www.health.state.ga.us/programs/tb) in the Public Health Clinic Forms section. The flow sheet is a valuable aid in the case management of TB/HIV patients as it captures all the information (such as CD4 count), medication history and recommendations. Dose counting is only valid for standardized regimens.
Case Management
Case management is vital to ensuring an individual successfully completes a course of TB treatment to final cure. Case management means the assignment of one person to be primarily accountable and responsible for making sure the medical, psychological and social needs of the patient with TB disease or infection are met throughout the course of treatment. The case manager is accountable for ensuring each patient is educated about TB and his/her treatment, treatment is appropriate and contacts are examined and complete therapy. To accomplish this, the case manager uses a multi-disciplinary team approach consisting of the patient, the nurse, the physician and other disciplines identified during initial and ongoing assessments to assist the patient to achieve treatment to cure. Examples of team members that may be involved in meeting patient's needs are a social services provider, a DOT worker, peer educators, clergy and representatives from government agencies and community based organizations. This multi-discipline approach of management reflects best practices for patient care. An example of a tool that can be used to describe and measure case management activities can be found in Appendix F and is titled "Goal Matrix Tool: Uniform Clinical Performance Measures for TB Nurse Case Managers". This tool can be used in different ways for programmatic evaluation, education, supervision and selfassessment.
Georgia Tuberculosis Policy and Procedure Manual 2009

49
X. CONTACT INVESTIGATION
A. Goal
Ninety-five percent (95%) of close contacts to smear positive TB cases will receive evaluations (medical history, TST, CXR)
At least 95% of infected contacts under age 15 years of age and 75% of infected contacts 15 years of age and over placed on treatment for latent TB infection (LTBI).
B. Refer to CDC MMWR Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis
Georgia follows the CDC MMWR Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis. Recommendations from the National Tuberculosis Controllers Association and CDC. December 16, 2005. Vol. 54. No. RR-15 .
See "Instructions for Completely Evaluated Contacts" on the current form #3126 Contact Investigation form located on the TB program web site (http://health.state.ga.us/programs/tb).
The ideal initial encounter with a contact is made within 3 days in order to gather background information, make a face-to-face assessment of the person's health and assign the appropriate priority.
Any symptomatic contact needs to have a chest x-ray and sputum specimens obtained as part of the evaluation regardless of assigned priority or TST result. Some contacts may have a false negative reaction to TST due to HIV/AIDS, treatment with steroids or immunosuppressive drugs, old age, or tuberculosis disease. IF such is suspected, the contact should have a chest x-ray.
Pulmonary / Laryngeal Cases:
1. High Priority - Initial encounter 3 - 7 days from notification with medical evaluation completed within 5 days of initial encounter (10 days if smear negative). Medical history, exposure history and a physical assessment Initial TST < 7 days if not done during initial encounter Any TST with induration > 5mm followed up with a chest x-ray
Georgia Tuberculosis Policy and Procedure Manual 2009

50
HIV testing and referral Follow-up TST 8-10 weeks later Place on LTBI treatment if indicated A contact considered at medical risk* to TB disease should be
evaluated immediately and undergo the following regardless of TST result:
1. Chest X-Ray 2. Initiate window period prophylaxis with appropriate
anti-tubercular medication if the chest X-Ray is negative for active TB disease 3. Determine the need for a full course of treatment
2. Medium Priority Initial encounter < 14 days with medical evaluation completed within 10 days of initial encounter Medical history, exposure history and a physical assessment Initial TST < 14 days if not done during initial encounter Any TST with induration > 5mm followed up with a chest x-ray HIV Counseling, Testing and Referral Follow-up TST 8 -10 weeks later Place on LTBI treatment if indicated
3. Low-Priority Initial encounter < 30 calendar days after notification Medical history, exposure history and a physical assessment TST 8 - 10 weeks later Any positive TST result should be followed up with a chest XRay Place on LTBI treatment if indicated
* A contact considered a medical risk has a particularly high risk of developing TB disease once infected with M. tuberculosis. Medical risk is defined by the presence of one of the following:
Immunosuppressed o HIV infection o prolonged corticosteroid therapy (e.g. more than 15 mg. prednisone or equivalent for 4 or more weeks) o cancer chemotherapy o anti-rejection drugs for organ transplant o tumor necrosis factor alpha (TNF) antagonists
Medical conditions such as o diabetes mellitus o silicosis o leukemia o lymphoma o cancer of head or neck o end stage renal disease
Georgia Tuberculosis Policy and Procedure Manual 2009

51
o gastrectomy o jejunoileal bypass Less than 5 years of age
Initiate window period prophylaxis with appropriate anti-tubercular medication based on clinical findings after active TB is ruled out. Treatment can be discontinued if the follow-up TST result is negative. If the follow-up TST result is positive, continue the treatment for the full course. EXCEPTION: A full course of treatment is recommended regardless of the result of the follow-up TST result in the following:
HIV infected Anti-rejection drugs for organ transplant Tumor necrosis factor alpha (TNF) antagonists
Pulmonary / Laryngeal Cases - Sputum Smear AND Culture Negative: Source Case Investigations for children < 5 with active TB disease: Extra-pulmonary cases:
1. Initial encounter < 30 days after notification (household contacts only)
2. Medical history, exposure history and a physical assessment 3. Initial TST, if negative then no further action is needed 4. Initial TST, if positive then follow-up with a chest X-Ray 5. Place on LTBI treatment if indicated
The contact investigation form (#3126) should be accurately completed and signed on all index cases. Use the following codes as indicated:

CODES:
a) Reason LTBI Therapy Stopped:

b) Reason Why CI not completed for contact

1. Completed Therapy 2. Death 3, Moved 4. Active TB Developed 5. Adverse Reaction 6. Chose to Stop 7. Lost to Follow-Up 8.Provider Decision

1. Still following up 2.No TST2 because 1st TST done 8-10 weeks after exposure 3. No TST2 because extrapulmonary source case 4. No TST2 because sputum/culture negative source case 5. Refused/uncooperative 6. Moved 7. Lost to follow up 8. Died 9. Other

c) Reason Why No contacts entered
1. Contact investigation was not done 2. Case died or too ill to interview. No surrogate interviewee available. 3. Case uncooperative/refused to identify contacts. No surrogate interviewee available. 4. Case moved/lost-to follow-up. No surrogate interviewee available. 5. Contacts identified but can not be located 6. Contacts uncooperative/refused 7. Contacts moved/lost to follow-up 8. Shares same contacts with an index case whose contacts have already been entered. 9. Mass screening done. Cannot distinguish between close and casual contacts. 10. Other

Georgia Tuberculosis Policy and Procedure Manual 2009

52
The TB Coordinator will evaluate the need to expand the investigation. Contact Investigation forms should be reviewed for completeness and signed by the TB Coordinator and sent to the State TB Office (2 Peachtree St. Suite 12 -476, Atlanta, GA 30303 Fax: 404-463-3460) within 30 days. All contacts need to be promptly entered into SENDSS.
C. Contact Investigations Across Health Districts / States
The clinic nurse who conducts the contact investigation is responsible for documenting all the follow-up and evaluation of contacts listed on the contact sheet. The TB Coordinator is responsible for reviewing and making sure all information is documented and complete.
Different County/Same District:
The clinic nurse makes arrangements with the health department in contact's county of residence for testing, x-rays and follow-up. The nurse should make arrangements to have the dates and results faxed to her. Notify state unit.
Different District:
District TB Coordinators should be notified of cross-district contact investigation and continue to monitor follow-up to ensure all contacts are identified and evaluated. Local health department TB nurses should complete the contact investigation form with full name and location information. This form should be forwarded to the receiving county health department for evaluation and returned once it is completed to the originating health department. When the potential exists for screening large numbers of individuals or attracting media attention, health directors and the state office should be notified.
Different State:
Contacts to Georgia cases that move out of state should be entered on the appropriate notification form (see forms section) and forwarded to the State TB Program, which will notify the new state of the contact's residence. When (if) the follow-up information is received from the new state, the TB Program will forward the information to the District TB Coordinator. When the Georgia TB Program is notified of contacts entering Georgia from other states, the information is forwarded to the appropriate District TB Coordinator. When (if) follow-up information is returned to the TB Program, it is forwarded to the original state that submitted the contact information.
Georgia Tuberculosis Policy and Procedure Manual 2009

53

XI. LATENT TUBERCULOSIS INFECTION (LTBI)

People who have TB infection but not TB disease are NOT infectious.

People who have TB infection but not TB disease are NOT infectious; in other words, they cannot spread the disease to other people. These people usually have a normal chest xray. It is important to remember that TB infection is not considered a case of TB. Major similarities and differences between TB infection and TB disease are shown in the following table.

LTBI VERSES TB DISEASE

LTBI

TB Disease (in the lungs)

Tubercle bacilli in the body

Tuberculin skin test reaction usually positive

Chest x-ray usually normal Sputum smears and cultures negative No symptoms
Not infectious Not a case of TB

Chest x-ray usually abnormal Sputum smears and cultures positive Symptoms such as cough, fever, weight loss Often infectious before treatment A Case of TB

A. Treatment for LTBI
LTBI treatment consists of 9 months of daily isoniazid (INH) or 4 months of Rifampin (RIF). Monthly clinical monitoring is indicated for all patients. Monitoring includes patient education about signs and symptoms that can result as adverse effects of the drug(s) being prescribed, a brief physical assessment checking for signs of hepatitis and adherence. See Nurse Protocol for LTBI Therapy candidates and treatment regimen. Refer clients with complications to consulting physician.
B. Stopping and Starting LTBI Therapy
Unfortunately, non-compliance with INH LTBI Therapy is common. The management issues for a client who stops his/her LTBI Therapy and then agrees to restart are two-fold: 1) ascertain the client has not developed active tuberculosis in the intervening time, and 2) prioritize TB program resources to prevent expenditure of excess efforts on non-compliant clients at the expense of follow up on cases and contacts. Stopping and starting LTBI therapy does not cause drug resistance if the client is truly only infected and does not have active disease.
Georgia Tuberculosis Policy and Procedure Manual 2009

54 Recommendations on reevaluating and restarting medications should be based on local district policy. In most cases, an attempt should be made only one time per client to restart LTBI treatment. However, there is an exception for very high-risk clients (e.g. HIV infection or children). For these very high risk clients, a second or even a third attempt is worthwhile if it is possible the client will be more compliant (consistent with local protocol). If therapy has lapsed for more than two months, a medical examination and chest x-ray to rule out active TB disease is indicated. Incentives should be considered to improve compliance. For further information, contact the District TB Coordinator or contract physician.
Georgia Tuberculosis Policy and Procedure Manual 2009

55

XII.

PHARMACY INFORMATION

A. Tuberculin Purified Protein Derivative (PPD) Stabilized Solution for Mantoux Skin Testing In Humans

Indications:

Tuberculin PPD is recommended to detect infection with M. tuberculosis or to aid in diagnosing tuberculosis. It may also be used as a verification test in individuals who have had reactions to skin tests using multiple puncture devices.

Activity:

The reaction to tuberculin injected intradermal is delayed hypersensitivity reaction and consists of indurations due to fluid and cell infiltration. Vesiculation and necrosis occur occasionally.

A delayed hypersensitivity reaction to tuberculin is a manifestation of previous infection with M. tuberculosis or a variety of nontuberculous mycobacteria. Natural infection with M. tuberculosis or vaccination with BCG vaccine usually induces sensitization. Sensitization following infection with mycobacteria occurs primarily in the regional lymph nodes. Sensitized lymphocytes (T-lymphocytes), which develop in response to the antigenic stimulus, enter the blood vascular system and circulate for an extended period of time. These sensitized lymphocytes when stimulated with the same or similar type antigens including Tuberculin Purified Protein Derivative, evoke a local reaction mediated by these cells.

Delayed hypersensitivity reactions to Tuberculin PPD can begin as early as 5 to 6 hours and peak at 48 to 72 hours. The reaction subsides over the course of several days. Some individuals may have a slower reaction, which may not peak until after 72 hours.

Immediate hypersensitivity may occur due to the constituents of the diluent (Tween 80. phenol) used in PPD solutions.

How Supplied: Dosage:

1 ml or 5 ml vials. 0.1ml of a 5 TU/0.1 ml solution intradermal by Mantoux method

Precautions:

The possibility exists of allergic reactions in individuals sensitive to the solution. Epinephrine Solution (1:1000) should be readily available for use in case an anaphylactic or acute hypersensitivity reaction occurs.

Georgia Tuberculosis Policy and Procedure Manual 2009

56
Failure to store and handle PPD as recommended will result in a loss of potency and inaccurate test results. PPD must be stored in the refrigerator and away from light. A vial of Tuberculin PPD that has been opened and in use for one month should be discarded because oxidation and degradation may have reduced potency. Solution that has been drawn up should be administered immediately.
Reactivity to the test may be depressed or suppressed in individuals who are receiving corticosteroids or immunosuppressive agents, who have viral infections (measles, mumps, chicken pox), overwhelming tuberculosis, other bacterial infections, or malignancy. Reactivity to PPD may be temporarily depressed by certain live viruses (measles, mumps, rubella). Therefore, if a tuberculin test is to be performed, it should be administered either before or simultaneously with the injection of measles, mumps, and rubella vaccines in combined form or as separate antigens. If MMR has been given previously there must be a six-week interval before administering PPD.
B. Furnishing Purified Protein Derivative (PPD)
The districts/county health departments providing PPD to facilities outside of public health clinics (county jails, homeless shelters, long term care facilities, substance abuse centers) must have a written agreement indicating collaboration with these facilities to provide reporting information to assure appropriate screening for, or control of, Tuberculosis. These facilities must sign a form indicating that there is a mechanism in place with the county/district TB Program for reporting the test results. District TB coordinators should contact these facilities to ensure that such a mechanism is in place and the agreement is current. If the agreement is not kept, the requests for PPD from the Health District will be denied. In addition to federal laws that address diversion of preferentially priced drugs, legal requirements for possession and proper handling/storage/record keeping of medications must be met by these facilities as well.
Georgia Tuberculosis Policy and Procedure Manual 2009

57

Sample PPD Solution Agreement

DISTRICT (enter district # or name of district here) AGREEMENT FOR PROVISION OF (enter PPD here) TO (enter name of collaborating facility/clinic/etc. here)

It is the policy of (enter district # or name of district here) to support local efforts in Tuberculosis Prevention and Control.

The (enter district name or county health department name here) will supply (enter PPD and, whether 10 test or 50 test vial, here) to (enter name of collaborating facility/clinic/etc. here) in a collaborative effort in screening for Tuberculosis. No more than a 3 months supply will be provided at any time. The agreement will be effective on the date signed and can be terminated when mutually agreed by both parties or by (enter district/county health department name) when reporting documentation is not forthcoming.

The (enter name of collaborating facility/clinic/etc. here) agrees to provide the (enter district name or county health department name here) with all requested information for reporting and follow-up as described herein: (enter reporting requirements or indicate "see attached report" and how often or date(s) report(s) are due).

In addition, (enter name of collaborating facility/clinic/etc. here) agrees that by State law this facility can legally possess prescription drugs. Also, (enter name of collaborating facility/clinic/etc. here) agrees to adhere to federal laws that address diversion of preferentially priced drugs and to the legal requirements for storage, handling and record keeping of drugs.

IN WITNESS THEREOF, this (enter word agreement or contract here) has been entered into as evidenced by the signatures affixed below.

DISTRICT

CONTRACTOR

_____________________ (PRINTED NAME OF HEALTH DIRECTOR)

_____________________ (PRINTED NAME OF FACILITY GEORGIA STATE LICENSED MEDICAL DIRECTOR AND/OR PHARMACIST)

Date Signed____________

Date Signed______________

Georgia Tuberculosis Policy and Procedure Manual 2009

58

Sample Report: Surveillance for Tuberculosis

Check one: Jail Substance Abuse Center Other

Name/Phone # of Facility _______________________________________/( )____________

County

______________________________

Quarter/Year

___________ / __________

RESIDENTS/CONSUMERS:

Number of New Residents/Consumers _______

Number undergoing Tuberculin Testing _______

Number Read ________ Number Positive on First Test __________

Number Positive after two-step Testing __________

Total Positive _______________

EMPLOYEES: Note: If employees are tested by another provider, report the information from the verified reports of their testing treatment in the appropriate column.

NEW EMPLOYEES:

Number of New Employees _____ Number Undergoing Tuberculin Testing _________

If there are new employees who do not undergo testing, state why (i.e., previous positive, treatment for LTBI, history of active TB disease) _______________________________________________________________________________ _________________________________________________________

At Nursing Home/Substance Abuse Center Other Providers

Number Positive on First Test

___________

___________

Number Positive after 2-step testing

____________

___________

Total Positive

____________

___________

EMPLOYEES: ANNUAL TESTING OF EMPLOYEES

Number Undergoing Tuberculin Testing this Quarter ________________________

Number Read ________________

Number Positive _______________

Fax this quarterly report to your District TB Coordinator. Do not fax to state TB Program office

Georgia Tuberculosis Policy and Procedure Manual 2009

59 C. Second Line Therapy Steps to complete to receive the second line TB drugs: 1. District TB coordinator receives approval from the state medical consultant via authorization form 2. District TB coordinator contacts the district drug coordinator or pharmacy to have the order placed into Cardinal.com (district drug coordinator or pharmacist sends an e-mail to the State Pharmacy Section verifying the order was placed) 3. Once the State Pharmacy Section receives the signed second line approval form and the e-mail from the district drug coordinator/pharmacist, the pending order can be approved (if the product is not on hand locally) 4. The pharmacist can dispense the product (not distribute) the order. If there is no district pharmacist, seek contracted pharmacy services to dispense since there is no nurse protocol for second line drug treatment, therefore the nurse cannot dispense
Georgia Tuberculosis Policy and Procedure Manual 2009

60

Second Line Therapy Authorization Form

The items listed on this page are for complicated Tuberculosis (TB) cases only and require consultation with the TB Program Medical Consultant, Dr. Michael Leonard. Please fax to (404) 463-3460, a copy of the prescription and this form for Dr. Leonard's approval.

To contact Dr. Leonard: Call 404- 657-2634 or email mleonard@dhr.state.ga.us or mkleona@emory.edu

NAME OF PATIENT: ___________________________________________________

DISTRICT: ________________ DATE OF ORIGINAL REQUEST: ______________

REQUESTOR NAME: _________________SIGNATURE: _____________________

APPROVED: [Dr. Leonard's Signature] ____________________________________

DATE OF APPROVAL: __________APPROVAL GOOD UNTIL: ______________

FAX SIGNED FORM TO: _______________________________________________

MEDICATION REQUESTED FOR: New Patient Continued drug treatment

Levofloxacin(tablets)500mg,50/Bt. 750mg 50/Bt.

Moxifloxacin(tablets) 400mg, 30/BT.

Streptomycin 1gm, vial. (Refrigerate)

Kanamycin(vial)1gm,3ml vial.

Capreomycin(vial)1gm,10ml vial.

Amikacin(vial)500 mg, 2mL vial. 1gm, 4mL, vial

Ethionamide (tablets) 250mg, 100/Bt.

Cycloserine (capsules) 250mg, 40/Bt.

Clofazimine(capsules)50mg,100/Bt.

Para-aminosalicylic acid (packets) 4gm, 30pks/carton. (Refrigerate)

Rifampin(vial) 600mg, 10mL/VL

Prednisone 5mg

Prednisone 10mg

Dexamethasone 4mg

DPH TB Unit [for Internal Use Only] Form 2nd Line (Rev. 06/2008)

Georgia Tuberculosis Policy and Procedure Manual 2009

61
D. General Information Medication Laboratory Assistance
Laboratory procedures regarding tuberculosis drug treatment can be accessed through the National Jewish Medical and Research Center in Denver, Colorado at (303) 398-1314. The payment for the service(s) will be a District/County responsibility.
Drug Information
The State Office of Pharmacy provides drug information for professional and client education for anti-tuberculosis drugs. The staff reviews prescribed dosages and other client variables and recommends needed dosage changes and notifies physician/nurse of potential problems. They use specialized knowledge, appropriate library materials and other available resources to provide consultation to staff on drug therapy. Also, they maintain an awareness of TB drug treatment trends and changes in the field and take appropriate and timely action to update department information.
INTRAVENOUS (IV) Medications
For clients requiring IV TB antibiotics, the State TB Program will request the IV TB antibiotic drugs from the State Office of Pharmacy. The State Office of Pharmacy will provide the medication to the nearest District Health Department. A licensed practitioner that can possess the IV TB antibiotic drugs will transport the drugs, if needed. Supplies for administration of the antibiotics, including solution for flushes, are not provided by the Office of Pharmacy and will need to be procured locally.
Compounded Medications
Medications can be obtained in suppository form for special cases by contacting the TB Program Manager for approval. The State Office of Pharmacy will provide assistance in locating a compounding pharmacy. The process to obtain reimbursement is:
The district should prepare a detailed invoice, including client's name, dates, drugs, amount, etc.
Mail the invoice/bill to the State TB Program, attn. TB Program Manager The State TB Program will reimburse the district.
Georgia Tuberculosis Policy and Procedure Manual 2009

62

XIII.

INFECTION CONTROL

Estimating the Infectiousness of a TB Patient
General Principles
Transmission of M. tuberculosis is most likely to result from exposure to persons who have 1) unsuspected pulmonary TB disease and are not receiving antituberculosis treatment, 2) diagnosed TB disease and are receiving inadequate therapy, or 3) diagnosed TB disease and are early in the course of effective therapy. Administration of effective antituberculosis treatment has been associated with decreased infectiousness among persons who have TB disease. Effective treatment reduces coughing, the amount of sputum produced, the number of organisms in the sputum, and the viability of the organisms in the sputum. However, the duration of therapy required to decrease or eliminate infectiousness varies. Certain TB patients are never infectious, whereas those with unrecognized or inadequately treated drug-resistant TB disease might remain infectious for weeks or months. In one study, 17% of transmission occurred from persons with negative AFB smear results. Rapid laboratory methods, including PCR-based techniques, can decrease diagnostic delay and reduce the duration of infectiousness.
The infectiousness of patients with TB correlates with the number of organisms they expel into the air. The number of organisms expelled are related to the following factors: 1) presence of cough lasting >3 weeks; 2) cavitation on chest radiograph; 3) positive AFB sputum smear result; 4) respiratory tract disease with involvement of the lung or airways, including larynx; 5) failure to cover the mouth and nose when coughing; 6) lack of, incorrect or short duration of antituberculosis treatment; or 7) undergoing cough-inducing or aerosol-generating procedures (e.g., sputum induction, bronchoscopy, and airway suction). Closed and effectively filtered ventilatory circuitry and minimized opening of such circuitry in intubated and mechanically ventilated patients might minimize exposure.
Persons with extrapulmonary TB disease usually are not infectious unless they have concomitant pulmonary disease, nonpulmonary disease located in the oral cavity or the larynx, or extrapulmonary disease that includes an open abscess or lesion in which the concentration of organisms is high, especially if drainage from the abscess or lesion is extensive, or if aerosolization of drainage fluid is performed. Persons with TB pleural effusions might also have concurrent unsuspected pulmonary or laryngeal TB disease. These patients should be considered infectious until pulmonary TB disease is excluded. Patients with suspected TB pleural effusions or extrapulmonary TB disease should be considered pulmonary TB suspects until concomitant pulmonary disease is excluded.
Although children with TB disease usually are less likely than adults to be infectious, transmission from young children can occur. Therefore, children and adolescents with TB disease should be evaluated for infectiousness by using the majority of the same criteria as for adults. These criteria include presence of cough lasting >3 weeks; cavitation on chest radiograph; or respiratory tract disease with involvement of lungs, airways, or larynx.
Georgia Tuberculosis Policy and Procedure Manual 2009

63
Infectiousness would be increased if the patient were on nonstandard or short duration of antituberculosis treatment or undergoing cough-inducing or aerosol-generating procedures (e.g., sputum induction, bronchoscopy, and airway suction). Although gastric lavage is useful in the diagnosis of pediatric TB disease, the grade of the positive AFB smear result does not correlate with infectiousness. Pediatric patients who might be infectious include those who are not on antituberculosis treatment, who have just been started on treatment or are on inadequate treatment, and who have extensive pulmonary or laryngeal involvement (i.e., coughing >3 weeks, cavitary TB disease, positive AFB sputum smear results, or undergoing cough-inducing or aerosol-generating procedures). Children who have typical primary TB lesions on chest radiograph and do not have any of these indicators of infectiousness might not need to be placed in an AII room.
Because the source case for pediatric TB patients might be a member of the infected child's family, parents and other visitors of all hospitalized pediatric TB patients should be screened for TB disease as soon as possible to ensure that they do not become sources of health-care--associated transmission of M. tuberculosis.
Patients who have suspected or confirmed TB disease and who are not on antituberculosis treatment usually should be considered infectious if characteristics include
presence of cough; cavitation on chest radiograph; positive AFB sputum smear result; respiratory tract disease with involvement of the lung or airways, including larynx; failure to cover the mouth and nose when coughing; and undergoing cough-inducing or aerosol-generating procedures (e.g., sputum
induction, bronchoscopy, and airway suction).
If a patient with one or more of these characteristics is on standard multidrug therapy with documented clinical improvement usually in connection with smear conversion over multiple weeks, the risk for infectiousness is reduced.
Suspected TB Disease
For patients placed under airborne precautions because of suspected infectious TB disease of the lungs, airway, or larynx, airborne precautions can be discontinued when infectious TB disease is considered unlikely and either 1) another diagnosis is made that explains the clinical syndrome or 2) the patient has three negative AFB sputum smear results. Each of the three consecutive sputum specimens should be collected in 8--24-hour intervals, and at least one specimen should be an early morning specimen because respiratory secretions pool overnight. Generally, this method will allow patients with negative sputum smear results to be released from airborne precautions in 2 days.
Hospitalized patients for whom the suspicion of TB disease remains after the collection of three negative AFB sputum smear results should not be released from airborne precautions until they are on standard multidrug antituberculosis treatment and are clinically
Georgia Tuberculosis Policy and Procedure Manual 2009

64
improving. If the patient is believed to not have TB disease because of an alternate diagnosis or because clinical information is not consistent with TB disease, airborne precautions may be discontinued. Therefore, a patient suspected of having TB disease of the lung, airway, or larynx is symptomatic with cough and not responding clinically to antituberculosis treatment should not be released from an AII room into a non-AII room, and additional sputum specimens should be collected for AFB examination until three negative AFB sputum smear results are obtained. Additional diagnostic approaches might need to be considered (e.g., sputum induction) and, after sufficient time on treatment, bronchoscopy.
Confirmed TB Disease
A patient who has drug-susceptible TB of the lung, airway, or larynx, who is on standard multidrug antituberculosis treatment, and who has had a substantial clinical and bacteriologic response to therapy (i.e., reduction in cough, resolution of fever, and progressively decreasing quantity of AFB on smear result) is probably no longer infectious. However, because culture and drug-susceptibility results are not usually known when the decision to discontinue airborne precautions is made, all patients with suspected TB disease should remain under airborne precautions while they are hospitalized until they have had three consecutive negative AFB sputum smear results, each collected in 8 to 24hour intervals, with at least one being an early morning specimen; have received standard multidrug antituberculosis treatment (minimum of 2 weeks); and have demonstrated clinical improvement.
Discharge to Home of Patients with Suspected or Confirmed TB Disease
If a hospitalized patient who has suspected or confirmed TB disease is deemed medically stable (including patients with positive AFB sputum smear results indicating pulmonary TB disease), the patient can be discharged from the hospital before converting the positive AFB sputum smear results to negative AFB sputum smear results, if the following parameters have been met:
a specific plan exists for follow-up care with the local TB control program; the patient has been started on a standard multidrug antituberculosis treatment
regimen, and DOT has been arranged; no infants and children aged <4 years or persons with immunocompromising
conditions are present in the household; all immunocompetent household members have been previously exposed to the
patient; and the patient is willing to not travel outside of the home except for health-care--
associated visits until the patient has negative sputum smear results.
Patients with suspected or confirmed infectious TB disease should not be released to health-care settings or homes in which the patient can expose others who are at high risk for progressing to TB disease if infected (e.g., persons infected with HIV or infants and
Georgia Tuberculosis Policy and Procedure Manual 2009

65
children aged <4 years). Coordination with the local health department TB program is indicated in such circumstances. See Policies regarding Isolation Status and Hospital Discharge of an Active Pulmonary TB Disease Suspect/Case (http://health.state.ga.us/programs/TB) and Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR 2005; 54 (No. RR-17). Drug-Resistant TB Disease Because the consequences of transmission of MDR TB are severe, certain infection control practitioners might choose to keep persons with suspected or confirmed MDR TB disease under airborne precautions during the entire hospitalization or until culture conversion is documented, regardless of sputum smear results. The role of drug resistance in transmission is complex. Transmission of drug-resistant organisms to persons with and without HIV infection has been documented. In certain cases, transmission from patients with TB disease caused by drug-resistant organisms might be extensive because of prolonged infectiousness as a result of delays in diagnosis and delays in initiation of effective therapy. HIV-Associated TB Disease Although multiple TB outbreaks among HIV infected persons have been reported, the risk for transmission does not appear to be increased from patients with TB disease and HIV infection, compared with TB patients without HIV infection. Whether persons infected with HIV are more likely to be infected with M. tuberculosis if exposed is unclear; however, after infected with M. tuberculosis, the risk for progression to TB disease in persons infected with HIV is high. Progression to TB disease can be rapid, as soon as one month after exposure.
Georgia Tuberculosis Policy and Procedure Manual 2009

66
XIV. PROGRAM EVALUATION
A. CASE REVIEW
To ensure all clients are provided the highest caliber of care, receive an appropriate TB regimen and protect the public's health, case reviews of current TB cases, suspects and their contacts will be conducted on a periodic basis. These reviews are conducted on a district rotation system. These reviews will be conducted in collaboration with TB medical consultants, TB nurses, and district TB coordinators
Key points covered during review include client drug treatment regimen, DOT compliance, current bacteriology status, radiology reports, HIV status and contact investigation process, with emphasis on contact follow-up. A form has been developed to assist with the periodic case review process. This form is posted on the TB web site.
B. TB PROGRAM REVIEW PROCESS
TB programmatic review at the local and district levels is part of the Quality Assurance/ Quality Improvement (QA/QI) for Public Health Nursing Practice initiative. The QA/QI process, Nurse Protocols, Practice Standards, Rules & Regulations and Program Standards ensure program accountability and accomplishment of the mission statement. This process is outlined in the Georgia DHR, DPH Quality Assurance/ Quality Improvement for Public Health Nursing Practice Manual. All efforts will be made to integrate programmatic reviews with the QA/QI process.
However, there may be instances where the state or district office will conduct separate programmatic reviews at the district and county level to address program needs and standards. The following may be used (but are not limited to)
1. Record Review for TB Disease 2. Record Review for LTBI 3. Client Education Guidelines Review 4. Infection Control QI Visits 5. Customer Satisfaction 6. Staff Education Guidelines 7. Contract deliverables
Georgia Tuberculosis Policy and Procedure Manual 2009

67
XV. TUBERCULOSIS CONFINEMENT AND GEORGIA LAWS
A. CONFINEMENT Confinement is to be used as the last resort in the management of a TB patient's care. From the start of care, the patient needs to understand what is expected during the course of TB treatment and the consequences if those expectations are not met. The expectations should be reinforced at each encounter with the patient until they are fully understood. During the first visit, the consent to treatment form (3144) and the treatment plan (3609) should be explained and agreements signed. In addition, a DOT agreement (DPH06/060W) needs to be negotiated and signed. At every patient encounter, adherence should be checked and documented. The TB Case Manager should analyze the patient's adherence rate during monthly evaluation sessions and more frequently as needed. Missed appointments need to be dealt with promptly according to the procedure below and efforts and results of efforts need to be documented as they occur.
a. Any missed DOT appointments will be brought to the attention of the TB Case Manager and dealt with promptly.
b. These steps will be followed and documented daily until DOT is reinstituted On the day of the missed appointment, the DOT worker will call all known telephone numbers for the patient. If unsuccessful, the DOT worker will go to the patient's house at the end of the work day to see if contact can be made On the second day, in addition to efforts stated above, telephone calls will be made to all known emergency contacts, employer, relatives and friends of the patient. Leave a note on the door in a plain, sealed envelope with the patient's name on it. Conduct a community search of known hangouts, neighbors and friends. On the third day, in addition to the efforts stated above, a certified letter should be sent to the patient's home. A team conference should be held to decide what steps should be taken from this point, including legal action.
c. Legal action may need to be initiated at this point, starting with an order from the district health director to appear for an appointment. The intensity and restriction increase from health department directives to court-ordered DOT to actual confinement. The process proceeds from the least to most restrictive measures. Confinement is a last resort measure all other options should be exhausted first.
CONFINEMENT PROCESS
1. Preparation for Providing Adequate Services
Preparation is VITAL. All involved people need to know what is expected of them PRIOR to an emergency situation. The TB coordinator is responsible for the preparation
Georgia Tuberculosis Policy and Procedure Manual 2009

68
by contacting the following in each county and working out agreements for a potential situation.
Administration General 1. Identify emergency housing for infectious and non-infectious. 2. Identify home health agencies, IV administration sites, medical supply companies, compounding pharmacies, community incentives, etc. 3. Discuss payment procedures. 4. How to handle media. Non-Compliance 1. Identify county procedure to follow. 2. Review contract with county attorney. 3. Discuss payment of legal fees. 4. Educate regarding court process & general TB education. 5. Identify local physician who will physically see client & testify in court.
Local Physician & Contract Physician Non-Compliance 1. Who will be responsible for testifying in court 2. Who will be responsible for physically seeing the client to evaluate 3. Who will be responsible for writing summary letter, letter to court & others as needed
Sheriff /County Jail Non-Compliance 1. Location of nearest Airborne Infection Isolation (AII) / negative pressure / male & female. 2. Responsibility to pick up and hold until court. 3. Agreement to house after court / DOT / work with HD. 4. Educate regarding TB Transmission / Infection Control. 5. Give resources.
Attorney Non-Compliance 1. Contact & introduce self 2. Explain process 3. Give resources 4. Give template of ideal court order 5. Provide general TB education
2. Procedure for Admission to/Discharge from Columbia Care Center
The district TB coordinator must inform the TB Unit manager (or designee) of the need for court ordered confinement of a client prior to the client's court hearing.
Georgia Tuberculosis Policy and Procedure Manual 2009

69
Prior approval by the TB Unit manager is required before a client can be admitted to Columbia Regional Care Center (CRCC) in South Carolina.
The Medical Data Summary Sheet must be completed by the district TB coordinator and faxed to the TB Unit manager (or designee) prior to the hearing date.
The detailed Medical Care Plan must be completed and signed prior to the client's transport to CRCC. This care plan should be placed on county health department letterhead/stationery. Prior to client's court date, fax the care plan to the TB Unit for review and approval.
The court confinement order must specify that the client will be in the custody of the county sheriff's department during the entire period of confinement. The county sheriff's department is responsible for transporting the client to CRCC and from the CRCC upon release.
The district TB coordinator will inform the county attorney/court of the client's date of admission to CRCC.
The district TB coordinator will ensure that a sealed copy of the client's current medical record, the signed court order specifying length of confinement, the signed medical care plan and a three-month supply of medication ordered for the treatment of tuberculosis are transported with the client to CRCC. This package should accompany the client to the court hearing and be given to the county sheriff's department staff person.
Please review the handout titled Columbia Regional Care Confinement Facility that details items clients are permitted to take to CRCC, what the center provides, etc.
The TB Unit manager will notify the district TB coordinator of the estimated cost of the monthly hospital admission. Invoices from Columbia Care Center should be promptly faxed (404-463-3460) to the TB Unit manager. Reimbursement for the cost of the client's care while at CRCC will be via Grant-In-Aid to the district.
CRCC will confirm the client's arrival and send monthly progress reports to the TB coordinator and the TB Unit. Please notify the nursing unit supervisor at the center if you do not receive monthly progress reports. The District TB contract physician will oversee case management of the client during his/her stay at CRCC. The TB Unit medical consultant will further review case management of these clients.
Discharge Planning: Prior to release from CRCC, the district TB coordinator should contact the client and CRCC to discuss and confirm discharge arrangements such as o Address on returning o Appropriate mode of return transportation (e.g., Greyhound bus, sheriff's department, family) o If needed, the client will be provided a prepaid phone card to contact the district TB coordinator/family/friends to ensure arrangements
Georgia Tuberculosis Policy and Procedure Manual 2009

70 3. Forms
MEDICAL DATA SUMMARY SHEET

Patient's Name: _______________________________ Gender: _________ DOB: ___________________

Allergies: _____________________ Last PPD: __________ Result: ________ Last H&P: _____________

RPR Date & Result: ___________________ HIV Date & Result: _________________________________

Primary Diagnosis: ________________________________________________________________________

All Chronic or Acute Medical Conditions: _____________________________________________________ ________________________________________________________________________________________

Mental Health History: (Check all that apply)

________ Substance Abuse ________ Alcohol ________ Drugs ________ Suicide Attempt Date _________ ________ History of Psychotropic Medications

Current Medications: Name

Dosage

Route

Frequency

Physical Disabilities: _________________________________________________________________

Assistive Devices/Prosthetics: __________________________________________________________

Please circle if applicable: Glasses Contact Lens Hearing Aid

Dentures/Partials

Vital Signs: Temp: ________ Pulse: ______ Resp: _______ B/P: _____________

________________________________________________________________________________________

Signature & Title: ___________________________________________ Date: ________________________

Stamp or Print Name: _________________________________ Phone Number: _______________________ HEALTH DISTRICT:____________________________________________________

Georgia Tuberculosis Policy and Procedure Manual 2009

71

MEDICAL CARE PLAN TEMPLATE for COLUMBIA CARE
Type the Medical Care Plan on your County Health Department's letterhead/stationery Current Date:
Medical Care Plan
Patient: Name Date of Birth Social Security #

Diagnosis:
I. Medications: (Provide detailed directions. For PRN medications, please add reason for administration.)

II. Chest X-ray frequency: (Frequency of chest x-rays)

III. Laboratory testing: (Frequency of sputum examination, liver enzymes, vision tests, etc.)
IV. Miscellaneous:
(ID consult, negative pressure isolation room, frequency of recording patient's weight, social services referral if substance abuse counseling/drug rehab. is indicated, etc.)

Interchange:

Please send monthly reports of normal findings re: 1. Medical lab findings 2. Lab results 3. General condition and misc

Please notify us as soon as possible re: 1. Abnormal lab findings 2. Adverse reactions to medications 3. Any other pertinent abnormal findings

Physician's signature needed at end of sheet. Type physician's name underneath signature.

Georgia Tuberculosis Policy and Procedure Manual 2009

72 B. RULES OF DEPARTMENT OF HUMAN RESOURCES PUBLIC HEALTH CHAPTER
290-5-16 TUBERCULOSIS CONTROL TABLE OF CONTENTS
Rule 290-5-16-01: Purpose. Rule 290-5-16-02: Reporting. Rule 290-5-16-03: Duties and Responsibilities of the County Health Departments. Rule 290-5-16-04: Hospitalization of Committed Clients. Rule 290-5-16-05: Discharge of Committed Clients. Rule 290-5-16-06: Judicial Petitions. Rule 290-5-16-07: Repealed. Rule 290-5-16-08: Repealed.
Georgia Tuberculosis Policy and Procedure Manual 2009

73
290-5-16-.01 Purpose. (1) The purpose of this Chapter is to prevent spread of tuberculosis and to prevent the development of new cases. (2) The State Department of Human Resources or its designee (Department) has the responsibility of developing procedures to ensure that persons with suspected cases of tuberculosis receive prompt diagnostic tests and persons with confirmed cases are given written treatment plans and an adequate oral explanation thereof which, if observed, can prevent the disease from spreading and lead to the recovery of the client. (3) A person with pulmonary tuberculosis, and positive sputum, who refuses to take prescribed chemotherapy, is a threat to the health of the community. Each time this individual coughs or sneezes, living virulent tubercle bacilli are dispersed on droplet nuclei into the area. By inhaling these virulent bacilli, any individual living or being in close contact with this diseased person over a period of time may become infected with the disease. Furthermore, any person with tuberculosis who refuses to take the full-recommended course of therapy is a threat to the community due to the possibility of that person developing drug resistant tuberculosis. Authority Ga. L. 1933, p. 7; O.C.G.A. Secs. 31-2-4, 31-14-1, 31-14-10, 31-14-12. History. Original Rule entitled "Purpose" was filed and effective on July 19, 1965 as 270-5-8-.01. Amended: Rule renumbered as 290-5-16-.01. Filed June 10, 1980; effective June 30, 1980. Repealed: New Rule, same title, adopted. F. Dec. 16, 1993; eff. Jan. 5, 1994.
290-5-16-.02 Reporting. (1) In-client or out-client treatment of a case of active tuberculosis and treatment of a suspected case with two or more anti-tuberculosis drugs shall be reported to the Epidemiology and Prevention Branch of the Department through the local county health department or its designee (LCHD). The report shall state whether the case is still under treatment, the address of the case, the clinical status, treatment of the disease, the dates and results of sputum examinations and x-rays, instances of client noncompliance with the treatment plan and any other information required by the Department. Said reporting should be done either by the attending physician or by the designated person at a treating hospital or clinic, if any. Also laboratories shall report to the Epidemiology and Prevention Branch of the Department and the LCHD all confirmed cultures of mycobacterium tuberculosis. (2) A physician who attends a case of active tuberculosis shall examine or cause to be examined all persons working or living in close proximity to the client who have a significant risk of infection, and shall forward the results of said examinations to the Epidemiology and Prevention Branch of the Department and the LCHD. In the alternative, such physician may refer such persons to the LCHD for examination. An examination required by this section shall include such tests as may be necessary to diagnose the presence of tuberculosis. Authority Ga. L. 1933, p. 7; O.C.G.A. Secs. 31-2-4, 31-12-1, 31-12-2. History. Original Rule entitled "Instructions to Clients Not Hospitalized" was filed and effective on July 19, 1965 as 270-5-8-.02. Amended: Rule renumbered as 290-5-16-.02. Filed June 10, 1980; effective June 30, 1980. Repealed: New Rule entitled "Reporting" adopted. F. Dec. 16, 1993; eff. Jan. 5, 1994.
Georgia Tuberculosis Policy and Procedure Manual 2009

74 290-5-16-.03 Duties and Responsibilities of the County Health Departments. (1) It is the general responsibility of the LCHD to see that proper and reasonable measures are put into effect to prevent the spread of tuberculosis from any person capable of spreading it. In order to fulfill its responsibility the LCHD shall: (a) ensure that all available tuberculosis control services are accessible to all residents; (b) secure the prompt reporting of all diagnosed or suspected cases of tuberculosis; (c) ensure effective treatment and continuing medical Supervision of suspected and diagnosed cases of tuberculosis; (d) ensure that contacts are identified and brought to examination, diagnostic conclusion and appropriate treatment if needed; (e) provide for the discharge from supervision of clients whose treatment has been successfully completed; and (f) keep each referring physician or institution informed as to the treatment of each referred client. (2) The LCHD shall promptly interview all reported or known persons who have a confirmed or suspected case of contagious tuberculosis. (3) If, upon information obtained by an agent, the LCHD has reasonable cause to conclude that a person has a suspected or confirmed case of tuberculosis which needs prompt medical evaluation, the LCHD shall issue to the person a written order directing him/her to appear at a specified time and place to comply with a written plan of evaluation. The LCHD shall attach to the order a statement containing its factual basis and shall inform the person of the right to respond in writing to allegations in the statement prior to the scheduled time of the evaluation. (4) If the person fails to submit to the planned evaluation and has not presented to the LCHD satisfactory reasons why such an evaluation is unnecessary, the LCHD may, in its discretion, file either a petition for an order of compliance or commitment. (5) If, upon information obtained by an agent of the LCHD, the LCHD has reasonable cause to conclude that a minor may have been exposed to tuberculosis, the LCHD shall issue an order to the parent, guardian or custodian of the minor directing him/her at a specified date and place either to allow tuberculosis screening of the minor by the LCHD or to provide evidence of such screening by a licensed physician. The LCHD shall attach to the order a statement setting forth its factual basis and shall inform the parent, guardian or custodian of his/her right to respond in writing to allegations in the statement prior to the specified date of the screening, or submission of evidence thereof. (6) If on the specified time the parent, guardian or custodian fails to submit the minor for screening and has not presented medical evidence or other written evidence that such screening is unnecessary, the Department may at its discretion file a petition for the screening of a minor in superior court. (7) After it has identified a confirmed or suspected case of tuberculosis, the LCHD shall seek to implement a written plan of treatment which shall be explained to the client who will be given an opportunity to consent to it in writing. (8) The written plan of treatment shall contain a detailed description of the required cooperation of the client and the set time schedule of any directly observed intake of prescribed drugs. (9) The LCHD shall also explain orally and in writing to the client the value of treatment and why drugs must be taken for the client's recovery, control of cough, the prevention of the possible emergence of drug resistant organisms, and to prevent the spread of the disease to others.
Georgia Tuberculosis Policy and Procedure Manual 2009

75 (10) If; upon information obtained by an agent of the LCHD, the LCHD has reasonable cause to conclude that a client is failing to comply with a plan of treatment, the LCHD shall issue a written order to the client directing him/her to present evidence of an intention to comply with the plan of treatment by a specified date. The LCHD shall attach to the order a statement setting forth its factual basis and shall inform the person of his/her right to respond in writing to the allegations in the statement prior to the specified date. (11) If by the specified date, the client fails to present to the LCHD evidence that he/she has complied or intends to comply with the plan of treatment, the LCHD may in its discretion issue a quarantine order against the client or file a judicial petition for an order of compliance or commitment. No such action, however, shall be taken against a client who voluntarily accepts in client treatment recommended by the LCHD. (12) Notwithstanding the provisions of any other regulation in this chapter, if the LCHD is unable to locate the person to be named in the petition after a good faith effort to do so, or if an imminent danger to public health exists, the LCHD may in its discretion file for a petition for commitment or compliance or issue a quarantine order without first issuing an order to the person. (13) If a person fails to comply with a quarantine order or a judicial order, the LCHD may institute contempt, injunction, or other judicial enforcement action against the person as is authorized by law. (14) The LCHD must notify the Director of the State Tuberculosis Control Program or his designee of the intent to initiate commitment proceedings and obtain confirmation of the availability of a bed for such client before instituting commitment proceedings. Authority Ga. L. 1933, p. 7; O.C.G.A. Secs. 31-2-4, 31-5-9, 31-12-3, 31-12-4, 31-14-2, 31-14-10, 3114-13, 37-1-21. History. Original Rule entitled "Duties and Responsibilities of the Health Department" was filed and effective on July 19, 1965 as 270-5-8-.03. Amended: Rule renumbered as 290-5-16-.03. Filed June 10, 1980; effective June 30, 1980. Repealed: New Rule entitled "Duties and Responsibilities of the County Health Departments" adopted. F. Dec. 16, 1993; eff. Jan. 5, 1994.
290-5-16-.04 Hospitalization of Committed Clients. (1) Upon commitment by court order of the superior court, individuals with tuberculosis are to be admitted to a facility approved by the Department for the treatment of tuberculosis clients (approved TB facility). (2) At the approved TB facility, each client shall receive the following: (a) a complete medical and laboratory evaluation upon admission by a licensed physician; (b) monthly x-rays as ordered; (c) monthly observed sputum examinations with cultures and sensitivity studies as required; (d) orders for prescribed drug regimens in the client's chart and signed by a licensed physician; (e) a medical evaluation at least once a month on the need for further commitment. 1. A copy of the monthly evaluation shall be forwarded to the committing LCHD. (3) If a committed client's behavior becomes unmanageable, he or she may be placed in the proper detention area for further treatment and counseling. If the approved TB facility's detention facilities prove inadequate, the client may be transferred to more secure facilities designated for the care of tuberculosis by the State TB Control Program. (4) Acutely ill clients may be transferred to an appropriate medical center for more intensive care.
Georgia Tuberculosis Policy and Procedure Manual 2009

76 (5) While these clients are in the hospital, no leaves of absence will normally be granted except for death or critical illness in the immediate family, medical reasons, or for other good cause approved by appropriate staff. (6) Committed clients shall not be deprived of any social or recreational privilege granted other clients unless the client is confined to a detention area. Clients confined to a detention area shall not be permitted off-unit privileges except as approved by medical staff. Authority Ga. L. 1933, p. 7; O.C.G.A. Secs. 31-2-4, 31-12-3, 31-12-4, 31-14-8, 31-14-10, 31-14-11, 37-1-21. History. Original Rule entitled "Hospitalization of Committed Clients" was filed and effective on July 19, 1965 as 270-5-8-.04. Amended: Rule renumbered as 290-5-16-.04. Filed June 10, 1980; effective June 30, 1980. Repealed: New Rule, same title, adopted. F. Dec. 16, 1993; eff. Jan 5, 1994.
290-5-16-.05 Discharge of Committed Clients. (1) The physical Status of a client shall be reviewed by the medical Staff on no less than a monthly basis. If no review has taken place within the past month, the client or his representative may request such a review. If, after such review, the designated responsible physician at the approved TB facility or the Tuberculosis Control Program that a committed client no longer has active tuberculosis or his/her discharge will not endanger the public health determines it, he/she shall be discharged if consistent with the order of commitment. (2) At least fifteen days prior to discharge, the LCHD or its designee must approve a suitable living environment in the community to which the client is to be discharged. (3) Upon discharge, the LCHD shall assume responsibility for directly observed therapy, certified sputum collections, chest x-rays and other clinical evaluations. If discharged clients are found to be noncompliant after discharge they are eligible for re-admission either as voluntary or recommitted clients. (4) The discharging physician must notify and file notice of intent to discharge a committed person from the hospital fifteen days prior to granting a discharge with each of the following: (a) Director of Tuberculosis Control Program, Department of Human Resources; and (b) Responsible LCHD from which the individual was committed. Authority Ga. L. 1933, p. 7; O.C.G.A. Secs. 31-2-4, 31-12-3, 31-12-4, 31-14-2, 31-14-8, 31-14-12. History. Original Rule entitled "Preadmission and Admission Provisions and Requirements" was filed and effective on July 19, 1965 as 270-5-8-.05. Amended: Rule renumbered as 290-5-16-.05. Filed June 10, 1980; effective June 30, 1980. Repealed: New Rule entitled "Discharge of Committed Clients" adopted. F. Dec. 16, 1993; eff. Jan. 5, 1994.
290-5-16-.06 Judicial Petitions. (1) The Department has concurrent authority with LCHD to file judicial petitions for commitment, orders of compliance, or contempt. (2) When filing a petition for commitment which asks that the person be taken into custody by the sheriff or his/her deputies prior to the judicial hearing, the LCHD, the Department or their designees shall attach to the petition either an affidavit signed by an agent which alleges that person named in the petition may abscond or conceal himself/herself and the factual basis thereof or an affidavit signed by a
Georgia Tuberculosis Policy and Procedure Manual 2009

77 physician which alleges that such person is an imminent danger to the public health and the factual basis thereof. Authority Ga. L. 1933, p. 7; O.C.G.A. Secs. 31-2-4, 31-12-3, 31-12-4, 31-14-2, 31-14-5, 31-14-10, 3114-13. History. Original Rule entitled "Admissions" was filed and effective on July 19, 1965 as 270-58-.06. Amended: Rule renumbered as 290-5-16-.06. Filed June 10, 1980; effective June 30, 1980. Repealed: New Rule entitled "Judicial Petitions" adopted. F. Dec. 16, 1993; eff. Jan. 5, 1994 290-5-16-.07 Repealed. Authority Ga. L. 1933, p. 7. History. Original Rule entitled "Management and Treatment of Committed Clients While in the Hospital" was filed and effective on July 19, 1965 as 270-5-8-.07. Amended: Rule renumbered as 290-5-16-.07. Filed June 10, 1980; effective June 30, 1980. Repealed: F. Dec. 16, 1993; eff. Jan. 5, 1994.
290-5-16-.08 Repealed. Authority Ga. L. 1933, p. 7. History. Original Rule entitled "Criteria for Discharge of Clients from Battey State Hospital" was filed and effective on July 19, 1965 as 270-5-8-.08. Amended: Rule renumbered as 290-5-16-.08. Filed June 10, 1980; effective June 30, 1980. Repealed: F. Dec. 16, 1993; eff. Jan. 5, 1994.
C. Georgia Official Code; Chapter 14, Title 31 Hospitalization for Tuberculosis
O.C.G.A 31-14-1
(a) As used in this chapter, the term 'active tuberculosis' means a diagnosis demonstrated by clinical, bacteriologic, or diagnostic imaging evidence, or a combination thereof. Persons who have been diagnosed as having active tuberculosis and have not completed a course of antituberculosis treatment are still considered to have active tuberculosis and may be infectious. (b) Active tuberculosis is declared to be dangerous to the public health.
O.C.G.A 31-14-2
When the county board of health or the Department of Human Resources has evidence that any person has active tuberculosis and is violating the rules and regulations promulgated by the department or the orders issued by the county board of health and thereby presents a substantial risk of exposing other persons to an imminent danger of infection, after having been directed by the county board of health or the department to comply with such rules, regulations, or orders, the county board of health or the department shall institute proceedings by petition for commitment, returnable to the superior court of the county wherein such person resides or, if such person is a nonresident or has no fixed place of abode, in the county wherein such person may be found. The petition executed under oath shall state the specific evidence supporting the allegations, that the
Georgia Tuberculosis Policy and Procedure Manual 2009

78 evidence has existed within the preceding 30 days, that the person named therein has active tuberculosis and is violating the rules and regulations of the department or the orders of the county board of health and presents a substantial risk of exposing other persons to an imminent danger of infection, after having been directed by the county board of health or department to comply with such rules, regulations, or orders, and that the public health requires commitment of the person named therein. The petition must be accompanied by a certificate of a physician stating that the physician knows or suspects that the person named therein may have active tuberculosis, the evidence which forms the basis of this opinion, and whether a full evaluation of the person is necessary.
O.C.G.A 31-14-3
(a) Immediately upon the filing of a petition pursuant to Code Section 31-14-2, the judge of the superior court shall set the matter for a full and fair hearing on the petition. Such hearing shall be held no sooner than seven days and no later than 12 days, excluding Saturdays, Sundays, and holidays, subsequent to the time of filing of the petition. The court shall serve personal notice of the hearing upon the person named in the petition and upon the petitioner. The notice required by this Code section shall include the time and place of the hearing; notice of the person's right to counsel, that the person may apply for court appointed counsel if the person cannot afford counsel, and that the court will appoint counsel unless the person indicates in writing that he or she does not wish to be represented by counsel; and notice that the person may waive his or her rights to a hearing under this Code section. A copy of the petition and physician's certificate filed under Code Section 31-14-2 shall be attached to the notice. The judge shall, where prayed for in the petition, provide for the examination of the person named therein by a physician licensed under Chapter 34 of Title 43, which examination shall include sputum examinations by a laboratory approved by the department and a recent chest X-ray of good diagnostic quality interpreted by a physician licensed to practice under Chapter 34 of Title 43, as a part of the order setting the matter for hearing; the order shall require the person or persons named therein to make such examination. Any X-ray and accompanying report or any written report as to a sputum examination shall be admissible as evidence without the necessity of the personal testimony of the person or persons making such examination and report. A physician may rely upon this evidence as the basis for the diagnosis of active tuberculosis and the defendant may offer opposing evidence on this issue by testimony or otherwise. All court costs incurred in proceedings under this chapter, including costs of examinations required by order of court but excluding any examinations procured by the person named in the petition, shall be borne by the county wherein the proceedings are brought. The fee to be paid to an attorney appointed under this Code section to represent a person who cannot afford counsel shall be paid by the county board of health instituting proceedings for commitment. (b) A full and fair hearing shall mean a proceeding before a hearing examiner under Code Section 31-14-8.1 or before the superior court in a proceeding under subsection (a) of this Code section. The hearing may be held in a regular court room or in an informal setting, in the discretion of the
Georgia Tuberculosis Policy and Procedure Manual 2009

79 hearing examiner or the court, but the hearing shall be recorded electronically or by a qualified court reporter. The person named as defendant shall be provided with the opportunity for the assistance of counsel. If the defendant cannot afford counsel, the court shall appoint counsel for the defendant or the hearing examiner shall request that the court appoint such counsel; provided, however, that the defendant shall have the right to refuse in writing appointment of counsel. Both parties shall have the right to confront and cross-examine witnesses, to offer evidence, and to subpoena witnesses. Both parties shall have the right to require testimony before the hearing examiner or in court in person or by deposition from any physician upon whose evaluation the decision of the hearing examiner or the court may rest. The hearing examiner and the court shall apply the rules of evidence applicable in civil cases, except as otherwise provided for in this chapter. The burden of proof shall be upon the party seeking commitment of the defendant. The standard of proof shall be by clear and convincing evidence. At the request of the defendant, the public may be excluded from the hearing. The defendant may waive his or her right to be present at the hearing. The reason for the action of the court or the hearing examiner in excluding the public or permitting the hearing to proceed in the defendant's absence shall be reflected in the record.
O.C.G.A 31-14-4
A copy of the petition and order shall be served on the person named in the petition. Any failure of such person to comply with the order or with the notice by the persons appointed therein to make examination shall be enforceable by attachment for contempt.
O.C.G.A 31-14-5
Where a danger exists that the person named in the petition may abscond or conceal himself or herself or where the person is conducting himself or herself so as to present a substantial risk of exposing other persons to an imminent danger of infection, the court may, as a part of the order made pursuant to Code Section 31-14-3, direct the sheriff or the sheriff's deputies to take such person into custody pending hearing and impose such confinement as will not endanger other persons. An affidavit shall be attached to the petition containing the specific facts supporting the need for custody pending hearing.
O.C.G.A 31-14-6
The person or persons appointed by the order to make the examination shall file a report thereof, in triplicate, in the court wherein the proceeding is pending. The clerk of the superior court shall forthwith make service of one copy on the agency instituting the proceeding and one copy on the
Georgia Tuberculosis Policy and Procedure Manual 2009

80 party named as defendant therein and the defendant's attorney, which service shall be personal or by certified mail or statutory overnight delivery.
O.C.G.A 31-14-7
(a) Upon the hearing set in the order, if the court finds that the person has active tuberculosis, is violating the rules and regulations promulgated by the department or the orders issued by the county board of health after having been directed by the county board of health or the department to comply with such rules, regulations, or orders, presents a substantial risk of exposing other persons to an imminent danger of infection, and there is no less restrictive available alternative to involuntary treatment at a hospital or facility approved by the department for the care of tubercular patients, then the court shall issue an order committing the defendant to the custody of the sheriff of the county or the sheriff's deputies to be delivered to the designated hospital or facility, where the defendant shall be admitted for care and treatment not to exceed two years. If the court does not find that the above standards are met, then the court shall dismiss the petition and the defendant shall be released from custody if taken into custody pursuant to Code Section 31-14-5. The costs of transporting such person to the hospital or facility shall be paid out of county funds. (b) An order for commitment shall be subject to review at the instance of either party by appeal.
O.C.G.A 31-14-8
Upon commitment the patient shall be confined in a hospital or facility approved by the department for the care of tubercular patients for a period not to exceed two years unless, before the expiration of such two-year period, the designated responsible physician of the tuberculosis inpatient unit determines that the following conditions no longer exist:
(1) The patient has active tuberculosis; or (2) The patient has active tuberculosis and there is a substantial likelihood of future noncompliance with a proposed treatment plan which will predictably lead to the development of infectious drug-resistant tuberculosis. The likelihood of noncompliance must be based upon a history of noncompliance with treatment; provided, however, that short emergency leaves in the event of death or critical illness in the family or short therapeutic leaves may be granted under conditions which would not adversely affect the public health and in accordance with rules and regulations established by the department.
Georgia Tuberculosis Policy and Procedure Manual 2009

81 O.C.G.A 31-14-8.1
(a) If it is necessary to continue confinement of a committed patient beyond a period of two years ordered by a court or hearing examiner or authorized under subsection (d) of this Code section, the designated responsible physician of the tuberculosis inpatient unit shall review and update the patient's treatment plan and shall prepare a report giving evidence of the necessity of such continued confinement. The report shall be prepared so as to allow sufficient time for the hearing authorized by this Code section to be conducted before the expiration of the two-year period of confinement. The report shall specify that, based upon clinical or X-ray evidence: (1) The patient is a person having active tuberculosis requiring continued commitment; or (2) The patient is a person having active tuberculosis with a substantial likelihood of future noncompliance with a proposed treatment plan which will predictably lead to the development of infectious drug-resistant tuberculosis. The likelihood of noncompliance must be based upon a history of noncompliance with treatment. (b) Such report shall be filed in the patient's medical record. A copy of the report shall be personally served on the patient along with a statement that the patient may, within 15 days after service of the report, file a request for a hearing to be conducted in accordance with the procedure for contested cases under Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act,' except as otherwise provided in this chapter, that the patient has a right to counsel at the hearing, that the patient may apply immediately to the superior court in the county where the committed patient is confined to have counsel appointed if the patient cannot afford counsel, and that the court will appoint counsel for the patient unless the patient indicates in writing that he or she does not desire to be represented by counsel or has made his or her own arrangements for counsel. Payment for such court appointed representation shall be made by the department. The hearing may be continued as necessary to allow the appointment of counsel. (c) If a hearing is requested within 15 days of service of the report on the patient, the hearing examiner shall set a time and place for the hearing to be held within 15 days of the time the hearing examiner receives the request. The hearing examiner may set a hearing if a request is made later than 15 days after service of the report if good cause is shown for the delay in making the request. Notice of the hearing shall be personally served on the patient, the hospital or facility, and, when appropriate, on counsel for the patient. Such hearing shall be a full and fair hearing, as described in Code Section 31-14-3, before a hearing examiner. After such hearing, the hearing examiner may issue any order which the court is authorized to issue under Code Section 31-14-7. (d) If a hearing is not requested within 15 days of service of the report on the patient, the department shall be authorized to continue confinement of the patient for an additional period not to exceed six months.
Georgia Tuberculosis Policy and Procedure Manual 2009

82 O.C.G.A 31-14-8.2
Either party may appeal any order of the superior court or hearing examiner in a proceeding under this chapter. An order of the superior court may be appealed to the Court of Appeals and the Supreme Court as provided by law but shall be heard as expeditiously as possible. The appeal of an order of a hearing examiner shall be to the superior court of the county in which the proceeding was held. The review shall be conducted by the superior court without a jury and shall be confined to the record. The court, upon request, may hear oral argument and receive written briefs. The patient must pay his or her costs upon filing any appeal authorized under this Code section or must make an affidavit that he or she is unable to pay costs. The parties shall retain all rights of review of any order of the superior court, the Court of Appeals, and the Supreme Court, as provided by law. The patient shall have a right to counsel on appeal or, if unable to afford counsel, shall have counsel appointed for the patient by the court. The appeal rights provided in this Code section are in addition to any other appeal rights which the parties may have.
O.C.G.A 31-14-9
(a) At any time after commitment and not more often than once every six months, the patient or any friend or relative having reason to believe that the patient no longer has active tuberculosis or that the patient's discharge will not endanger the public health may institute proceedings by petition in the superior court of the county wherein the confinement exists, whereupon the judge shall set the matter for a hearing to occur within 15 days requiring the person or persons to whose care the patient was committed, or their duly authorized agents, to show cause on a day certain why the patient should not be discharged. The judge shall also require that the patient be allowed the right to be examined prior to the hearing by a licensed physician of the patient's own choice and at the patient's own personal expense. Thereafter all proceedings shall be conducted in the same manner as are proceedings for commitment. (b) In addition to the above procedure for securing discharge, the patient or a friend or relative on behalf of such person may petition, as provided by law, for a writ of habeas corpus to question the cause and legality of detention and to request a court of competent jurisdiction to issue a writ for release, provided that a copy of the petition along with the proper certificate of service shall also be served upon the presiding judge of the court ordering such detention and upon the county board of health or the Department of Human Resources which initiated the petition for commitment pursuant to Code Section 31-14-2, which service shall be made by certified mail or statutory overnight delivery.
Georgia Tuberculosis Policy and Procedure Manual 2009

83 O.C.G.A 31-14-10
The county boards of health or their duly authorized agents shall, within their respective limits, enforce rules and regulations adopted by the department for the protection of the public against active tuberculosis.
O.C.G.A 31-14-11
Any person who leaves a hospital or facility approved by the department for the treatment of tuberculosis to which he or she has been committed by court order, without having been discharged by the medical staff of the tuberculosis inpatient unit or the community tuberculosis control unit, shall be taken into custody and returned thereto by the sheriff of any county where such person may be found, upon affidavit being filed with the sheriff by the designated responsible official of the hospital or facility to which such person has been committed.
O.C.G.A 31-14-12
No person having active tuberculosis who, in his or her home or other place, obeys the rules and regulations of the department and county boards of health for the control of active tuberculosis or who voluntarily accepts care in a hospital or facility operated for the care of tuberculosis, in his or her home, or in another place and who obeys the rules and regulations of the department and completes the prescribed course of therapy for the control of active tuberculosis shall be committed as prescribed in this chapter.
O.C.G.A 31-14-13
a) In lieu of the petition for commitment as authorized by Code Section 31-14-2, the county board of health or the department may petition the court for an order directing the person to comply with a plan of evaluation or outpatient treatment. The department may also petition the court for an order directing the parents, guardians, or custodians of persons under the age of 18 who have been exposed to tuberculosis to allow screening for tuberculosis by public health authorities or to provide evidence of such screening by a licensed physician. Proceedings, evidence, and hearings thereon will be in the same manner as with commitment petitions, and upon the hearing the court may dismiss the petition or order the person to comply with the screening, evaluation, or outpatient treatment plan. The court may also modify the plan prior to ordering compliance. (b) A petition for outpatient treatment as authorized by subsection (a) of this Code section may also be initiated by a county board of health or the department where a previously hospitalized,
Georgia Tuberculosis Policy and Procedure Manual 2009

84 diagnosed, or committed patient's condition no longer requires hospitalization or commitment but where protection of the public health requires continued treatment on an outpatient basis of said patient. (c) Any person known or suspected to have tuberculosis who fails to comply with a plan of evaluation or outpatient treatment ordered pursuant to this Code section, or any parent, guardian, or custodian of a person under the age of 18 who fails to comply with screening ordered pursuant to this Code section or who aids or abets such failure may be punished as for contempt. Contempt proceedings may be initiated by the filing of a petition by the county board of health or by the department with the superior court of the county of the patient's residence or the county where the patient may be found if a nonresident or without a fixed place of abode.
O.C.G.A 31-14-14
Any physician, peace officer, attorney, or health official, or any hospital or facility official, agent, or other person employed by a private hospital or facility or at a hospital or facility operated by the state, by a political subdivision of the state, by a county board of health, or by a hospital authority created pursuant to Article 4 of Chapter 7 of Title 31, who acts in good faith in compliance with the admission and discharge provisions of this chapter shall be immune from civil or criminal liability for his or her actions in connection with the admission of a patient to or the discharge of a patient from a hospital or facility approved by the department for the care of tubercular patients.
Georgia Tuberculosis Policy and Procedure Manual 2009

85 XVI. A GLOSSARY OF TUBERCULOSIS TERMS
This glossary contains many of the terms used in general public health nursing, as well as others which are frequently encountered by those who work specifically in tuberculosis control services. The definitions given are not dictionary definitions but are the ones most applicable to usage relating to tuberculosis.
ACID-FAST BACILLI (AFB) Bacteria which retain certain dyes even when washed with an acid solution. Only rarely are acid-fast bacteria seen on smear not mycobacteria. A presumptive diagnosis of tuberculosis is often made on the basis of a positive "AFB smear." However, the diagnosis is not confirmed until a culture is grown and identified as M. tuberculosis.
ACQUIRED DRUG RESISTANCE (ADR) Resistance to one or more antituberculosis drugs, which develops while a client is on therapy. Usually the result of erratic compliance with chemotherapy or inadequate dosing levels.
ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) A condition characterized by a breakdown in the body's immune system. When the immune system is weakened, the body can't fight off infections. A person with AIDS is susceptible to illnesses which ordinarily pose little or no threat to someone who is immune competent. The most common opportunistic illnesses attacking AIDS victims are a severe type of pneumonia and Kaposi's sarcoma, a rare cancer. Mycobacterial diseases such as Avium/intracellular and M. tuberculosis also present significant danger to these individuals.
ADVERSE REACTIONS Any undesirable effect of a medication. All dugs may cause such reactions. Periodic monitoring of tuberculosis clients on therapy may help detect or prevent those reactions.
AFB See acid-fast bacillus.
ALVEOLI The small air sacs in the lungs that lie at the end of the bronchial tree. The site of gas exchange in the lungs and the site where tuberculosis infection usually begins.
ANEMIA A condition in which there is a decreased volume of red cells in the blood. There are many causes of anemia, including chronic infections such as untreated tuberculosis.
ANERGY The inability to mount a delayed-type hypersensitivity response to one or several skin-test antigens because of a weakened immune system due to disease or medications. . ANOREXIA Loss of appetite. A symptom frequently seen in many illnesses, including tuberculosis.
Georgia Tuberculosis Policy and Procedure Manual 2009

86
ANTIGEN Any substance that is able to induce a specific immune response and to react with the products of that response (i.e., with specific antibodies or specifically sensitized tlymphocytes or both). PPD is one such antigen that induces an immune response when antibodies react to the protein of the tubercle bacillus in the body, producing the positive TB skin test seen by induration at the antigen location site.
ASYMPTOMATIC Without symptoms.
BACTEC A laboratory culture system that allows the early detection of mycobacterial growth by measuring the production of radioactive CO2 generated by growth of the organism in culture. The mean time for reporting M. tuberculosis bacterial growth by this method is approximately 15 18 days.
BACTERICIDAL Capable of killing bacteria. Isoniazid (INH) and Rifampin (RIF) are the two most potent bactericidal antituberculosis drugs.
BACTERIOLOGIC SPECIMEN Sample of body tissue or fluid submitted for testing for bacteria
BACTERIOSTATIC Capable of preventing bacterial growth but not necessarily capable of killing bacteria. Drugs such as Ethambutol (EMB) and Para-aminosalicylic Acid (PAS) are primarily bacteriostatic.
BCG (BACILLE CALMETTE-GUERIN) Vaccine for tuberculosis widely used in some parts of the world. It is of uncertain efficacy and is rarely used in this country.
BIOCHEMICAL TESTS In tuberculosis work, refers to special tests performed on mycobacterial cultures to determine which particular species of mycobacteria are growing. Also refers to various blood tests performed on clients.
BOOSTER PHENOMENON Seen when an individual has a diminished ability to react to tuberculin even though truly infected with mycobacteria. A series of tuberculin skin tests may be required to stimulate (boost) the immune system so that the test will be significant (positive).
BOVINE TUBERCULOSIS An illness of cattle caused by M. bovis, an organism which can also cause disease in man that is identical to that caused by M. tuberculosis. It may be transmitted by means of contaminated unpasteurized milk. It is rarely seen in this country because the reservoir of infected cattle has been essentially eliminated and dairy cattle are routinely screened for tuberculosis.
BRONCHI The hollow branches of the pulmonary tree that connects the trachea to the alveoli.
Georgia Tuberculosis Policy and Procedure Manual 2009

87
BRONCHIOLES The smallest bronchi.
CAPREOMYCIN (CM or CAP) An injectable antituberculosis drug related to Streptomycin (SM).
CAVITY A hollow space in the lung resulting from destruction of pulmonary tissue. May be caused by tuberculosis, or other pulmonary infections. Tuberculosis clients with cavities in their lungs are said to have "cavitary disease" and are often more infectious than clients without cavities.
CELL MEDIATED IMMUNITY Immunity in which participation of lymphocytes and macrophages is predominant. Usually seen as the localized immune response (or induration), which develops 24-72 hours after the intradermal injection of an antigen such as 5 TU PPD Mantoux.
CERTIFIED SPUTUM Sputum that is collected in the presence of health care personnel.
CHEMOTHERAPY Therapy for infection or TB disease by means of oral or injectable drugs.
CHEST X-RAY: APICAL LORDOTIC VIEW A special x-ray film taken in order to better visualize the apices (upper portions) of the lungs which are often affected by tuberculosis but which may be obscured by the clavicles (collar bones) in a standard view.
CHEST X-RAY: LATERAL VIEW An x-ray film taken from the side of the chest to improve visualization of identified abnormalities or allow area in question to be viewed from a different angle.
CHEST X-RAY: POSTERIOR ANTERIOR (PA) VIEW The most common x-ray view with the client standing facing the film and the x-ray source coming from the back.
CHEST X-RAY: TOMOGRAMS X-ray film taken using a special technique, that can focus on lesions in a particular plane (e.g. 5 centimeters from the back) in the chest.
COLONIZATION Presence of bacteria in or on part of the body, which causes neither disease nor a response by the individual's immune defense system. Clients colonized with nontuberculous mycobacteria may not require therapy.
COLONY Laboratory term used to quantify numbers of tubercle bacilli in a cultured specimen. Each microscopic bacterium, when grown in the laboratory, gives rise to one visible colony.
Georgia Tuberculosis Policy and Procedure Manual 2009

88 COMPLIANCE Refers to the willingness and/or ability of clients to maintain their share of the responsibility for their therapy by taking their medications as prescribed and by keeping necessary clinic appointments.
CONCENTRIC CIRCLE INVESTIGATION Contact Investigation following tuberculosis exposure, which revolves logically and systematically around a common center or axis. The common center is the index case (infectious person). This type of exposure management systematically elicits persons closest to (at higher risk) the index case. It moves outward from the center to include others at risk (low risk and/or nonhousehold individuals). This logical movement from high probability of infection among those exposed to TB prevents unnecessary testing while eliciting or targeting the at risk contact in the work, home and social environment.
CONSUMPTION A term used for tuberculosis prior to the 20th century.
CONTACT An individual who has shared the same air space with a case of tuberculosis for a sufficient amount of time so there is a probability that transmission of tuberculosis has occurred.
CONTAMINATION In tuberculosis, objects contaminated with tubercle bacilli (see "FORMITES") are very rarely associated with transmission. Air contaminated with infectious droplet nuclei is almost always the vehicle implicated in the spread of infection. May also refer to culture because of overgrowth (contaminated) by other more rapidly growing bacteria.
CONVERSION A tuberculin skin test conversion is defined as an increase of 10 mm or more of induration within a two-year period, regardless of age.
CULTURE The process of growing bacteria in the laboratory so that organisms can be identified by species characteristics.
CYCLOSERINE (CS) An oral antituberculin drug. DELAYED TYPE HYPERSENSITIVITY (DTH) A slowly developing cell-mediated immune response to a specific antigen.
DIRECT DRUG SUSCEPTIBILITY TEST A test performed from "digested sputum" or other body fluid that are smear positive for acid-fast organism. Such tests are reported at about 23-28 days, followed by final indirect drug susceptibility test if the culture is positive.
DIRECTLY OBSERVED THERAPY (DOT) A strategy devised to help clients adhere to treatment by having an individual, preferably a health care worker, observe the client ingest prescribed medication and assure its retention. The observation should be documented in the client's record. Chemotherapy (drugs) ingested by the client in the presence of a nurse or other health worker on a daily or intermittent regimen.
Georgia Tuberculosis Policy and Procedure Manual 2009

89 DISEASE Condition in which the body's normal structure or function is disturbed. A definite morbid process having a characteristic train of signs and/or symptoms.
DNA PROBE TEST An advanced laboratory method for detecting organisms using deoxyribonucleic acid, the genetic blueprint of cells. One type of DNA probe test is a Genprobe.
DROPLET NUCLEI The microscopic airborne particles of aerosolized sputum, which can carry tubercle bacilli to the alveoli of susceptible individuals.
DRUG SUSCEPTIBLITY TESTS Laboratory tests that determine if the tubercle bacilli cultured from a client can or cannot be killed by various antituberculous drugs.
ERYTHEMA In skin testing, refers to the area of redness around the injection site. It is not measured when the tuberculin test is read. Its presence can be noted in the documentation.
ETHAMBUTOL (EMB) An oral antituberculous drug.
ETHIONAMIDE (ETA) An oral antituberculous drug.
EXTENSIVELY DRUG RESISTANT TB (XDR-TB) TB disease caused by M. tuberculosis that is resistant to at least isoniazid and rifampin among first-line anti-TB drugs, resistance to any fluoroquinolone, and resistance to at least one second-line injectable drug (amikacin, capreomycin or kanamycin).
EXTRAPULMONARY Refers to tuberculosis outside of the lungs. In the United States, about 15 percent of reported cases involve extrapulmonary sites such as the kidney, pleura, lymph nodes, bone and brain.
FLUOROCHROME A technique for staining a clinical specimen with dyes, which fluoresce, in preparation for performing a microscopic examination (smear) for mycobacteria. This technique is usually available only in larger hospitals or in the United States laboratories and requires a special microscope.
FOMITES An article such as a book, dish, or article of clothing used or touched by a client. These are not involved in the transmission of tuberculosis.
GRANULOMA A nodular collection of cells (i.e., macrophages) that represents a chronic inflammatory response initiated by various infectious and noninfectious agents.
GASTRIC WASHINGS - Procedure sometimes used to obtain a specimen for culture when a client cannot produce adequate sputum. A tube inserted into the stomach is used to recover any bacilli that may have been coughed up and then swallowed.
Georgia Tuberculosis Policy and Procedure Manual 2009

90
GEN-PROBE A DNA probe test.
HEMOPTYSIS Coughing up blood. Sometimes seen in tuberculosis as well as in other pulmonary conditions.
HIPPOCRATES A physician of ancient Greece and the first to describe phthsis, the illness we now call tuberculosis.
HIV TESTING A blood test to detect antibodies to the AIDS virus. It does not diagnose AIDS. A positive test result is evidence of HIV infection. A person who tests positive may develop AIDS or ARC or remain a silent carrier of the AIDS virus. Anyone who tests positive can give HIV to others through sexual or blood contact.
HUMAN IMMUNODEFICIENCY VIRUS (HIV) The Human Immunodeficiency Virus (HIV) causes AIDS. Once a person is infected with the AIDS virus, he or she remains infected for life and can transmit the virus to others. Not everyone with HIV will develop AIDS. About 10 to 20 percent of those HIV infected will develop AIDS within five years of infection. They will develop one or more opportunistic diseases. Some will develop AIDS-Related Complex (ARC). People with ARC have not developed an opportunistic infection but may experience night sweats, fever, swollen glands, weight loss, loss of appetite, diarrhea, and fatigue. Many ARC victims later develop AIDS. Most people infected with the AIDS virus have no symptoms. They look and feel well; many have no idea they are infected with HIV. But these silent carriers can transmit AIDS virus to others.
INDEX CASE The first case brought to the attention of the health care provider. Usually becomes the focus for an initial contact investigation.
INDIRECT DRUG SUSCEPTIBILITY TEST A test performed on an acid-fast culture after it has produced growth of an organism such as M. tuberculosis or NTM.
INDUCED SPUTUM Material obtained from a client unable to cough up a sputum specimen spontaneously. The client inhales a mist of saline (salt water), which stimulates a cough from deep within the lungs.
INDURATION The area of raised palpable swelling or hardness that surrounds the site of injection of purified protein derivative.
INFECTION Condition in which virulent organisms, such as M. tuberculosis, are able to multiply within the body and cause a response from the host's immune defenses. Infection may or may not lead to clinical diseases.
Georgia Tuberculosis Policy and Procedure Manual 2009

91 INTERMITTENT THERAPY Therapy given on a twice weekly or thrice weekly basis and always directly supervised by a health worker. Useful for treating clients who are unable or unwilling to take their own medications regularly. Most times it is preceded by an initial period of daily therapy.
INTRADERMAL Between the two top layers of the skin. May also be termed intracutaneous.
ISONIAZID (INH) An oral bactericidal drug used alone or in combination with one or more other drugs in the therapy for tuberculosis disease or infection.
JAUNDICE Condition in which the skin and eyes appear yellow. Often the result of hepatitis (or other liver diseases), which can be caused by some antituberculous drugs.
KANAMYCIN (KM) Injectable antituberculous drug related to Streptomycin (SM). One of the groups of aminoglycoside drugs.
KOCH German scientist who discovered the tubercle bacillus in 1882.
LIVER FUNCTION TEST (LFT) Usually SGOT (AST), SGPT (ALT), and bilirubin.
LOWENSTEIN-JENSEN (LJ) MEDIUM A nutrient substance used in the laboratory on which tubercle bacilli and other mycobacteria are grown.
LTBI Latent Tuberculosis Infection. Condition in which living tubercle bacilli are present in an individual, without producing disease. The infected individual, although having a "significant" tuberculin reaction, usually feels well, has a normal chest x-ray, does not have a "positive" bacteriological examination (smear and culture), and is not infectious. However, the infected individual remains at lifelong risk of developing disease.
LYMPH NODES Small nodules of specialized immune cells located throughout the body. Those in the chest may be involved early in tuberculosis when bacilli are carried there by the lymphatic system. Nodes elsewhere in the body may also be affected later.
LYMPHATIC A small channel which carries fluid (lymph), white blood cells, and invading bacteria to the lymph nodes.
LYMPHO-HEMATOGENOUS - Refers to the spread of tubercle bacilli from the initial site of infection in the lungs by way of the lymphatic system and bloodstream to other parts of the body.
MALAISE - A general feeling of discomfort and fatigue usually associated with illness.
Georgia Tuberculosis Policy and Procedure Manual 2009

92 MANTOUX TEST (TST) Tuberculin skin test given by injecting a measured amount of liquid solution of purified protein derivative (PPD) intradermally with a needle and syringe. This is the most reliable and standardized technique for tuberculin testing.
MULTIDRUG-RESISTANT (MDR-TB) TB disease caused by M. tuberculosis organisms that are resistant to at least Isoniazid (INH) and Rifampin (RIF).
MICRON A metric unit of length, 1 micron = 1/1000 millimeter (approximately 25,000 microns in an inch). The tubercle bacillus is 0.2 to 0.5 micron in size.
MIDDLEBROOK 7H-10 MEDIUM A type of medium used to culture mycobacteria in the laboratory.
MILIARY TB Disseminated TB. Tubercle bacilli have been carried through the blood stream to many parts of the body. The minute lesions seen on the x-ray or biopsy look like millet seeds scattered throughout the tissue.
MILLIMETER (mm) Metric unit of length used to measure induration in tuberculin testing.
MONITORING Periodic observation and evaluation of a person's response to treatment or medication. Also applies to all persons with a documented significant tuberculin skin test who are being observed for the development of signs and symptoms of tuberculosis.
MULTIPLE PUNCTURE TESTS Tuberculin skin test in which an unmeasured amount of purified protein derivative is introduced into the skin by means of an array of sharp prongs (i.e., Tine, Heaf).
MYCOBACTERIUM (M.) The name of the genus to which Mycobacterium tuberculosis and all other mycobacteria belong (i.e. M. avium complex, M. kansasii).
MYCOBACTERIUM BOVIS Species of mycobacteria closely related to M. tuberculosis. Earlier in the century, M. bovis frequently caused disease in cattle and humans, especially in children who drank unpasteurized milk from infected cows. The vaccine BCG is derived from M. bovis.
MYCOBACTERIUM TUBERCULOSIS The mycobacterium organism that causes tuberculosis (often abbreviated as M. tuberculosis or M. TB).
NIACIN TEST An important biochemical test performed by the laboratory on a culture of mycobacteria. A "positive" niacin test almost always identifies M. tuberculosis.
NONPHOTOCHROMOGENS Certain nontuberculous mycobacteria, the colonies of which do not develop light induced pigmentation (i.e., M. avium complex).
Georgia Tuberculosis Policy and Procedure Manual 2009

93
NONTUBERCULOUS MYCOBACTERIA (NTM) Bacteria related to Mycobacterium tuberculosis but of a different species. Sometimes called "atypical mycobacteria" or "mycobacteria other than tuberculosis" (MOTT). NTM do not cause TB disease and are not usually spread person to person.
OLD TUBERCULIN (OT) The original type of tuberculin first discovered and used by Koch and still used on some multiple puncture tuberculin tests.
PARA-AMINOSALICYLIC ACID (PAS) An oral antituberculous drug.
PATHOGENESIS The natural evolution of a disease process in the body without intervention (i.e. without therapy)
PHOTOCHROMOGENS Nontuberculous mycobacteria which form pigmented colonies in the laboratory when exposed to light (e.g. M. kansasii).
PIGMENT Chemical substance made by some mycobacteria which give color to colonies grown in the laboratory. Presence or absence of pigment aids in the identification of particular species.
PREVENTABLE TB CASE A newly reported TB case that may have been prevented (with a high degree of statistical probability based on preventive therapy or case therapy trials) by adequate health care provider intervention. Examples include: 1) a converter, 2) person with previously untreated TB disease, 3) person with LTBI, or 4) known contact to an active case.
PRIMARY DRUG RESISTANCE Infection with a strain of M. tuberculosis that is resistant to drugs that existed prior to the beginning of therapy.
PRIMARY DRUGS term used to refer to the most commonly used antituberculous drugs: Isoniazid (INH), Rifampin (RIF), Ethambutol (EMB), and Pyrazinamide (PAZ).
PULMONARY Referring to the lungs. Most tuberculosis cases in the United States (85 percent) are pulmonary.
PURIFIED PROTIEN DERIVATIVE (PPD) Type of purified tuberculin preparation derived from tubercle bacilli that have been killed by heating. The standard Mantoux test uses 5 TU (tuberculin units) of PPD.
PYRAZINAMIDE (PZA) An oral antituberculous drug. It has recently become more important as a primary drug.
Georgia Tuberculosis Policy and Procedure Manual 2009

94 RAPID GROWERS Certain species of nontuberculous mycobacteria such as M. fortuitum which can produce visible colonies in as little as one week when cultured in the laboratory. M. tuberculosis usually takes 2-6 weeks.
REACTIVATION (second episode) Refers to clients who have achieved clinical well being, negative bacteriology, and radiologic stability as a result of chemotherapy but who become ill twelve (12) or more months after having discontinued or completed therapy for tuberculosis.
REGIMEN Any particular therapy plan for tuberculosis that specifies which drugs are used, what doses are ordered, the drug schedule and the length of the plan is "tailored" to client needs.
RELAPSE Refers to clients who have improved clinically and bacteriologically but become ill and/or have positive smears and cultures again while still on therapy. May be due to inadequate regimen, poor compliance or drug resistance. (Similar to reactivation)
RESISTANCE Refers to the ability of some strains of bacteria including M. tuberculosis to grow and multiply even in the presence of drugs which normally kill them. Such strains are referred to as "drug resistant strains"
RIFAMPIN (RIF) An oral bactericidal antituberculous drug.
ROENTGEN German scientists who discovered x-rays in 1895. Roentgen is also a measure of radiation.
ROENTGENOGRAM An x-ray film.
SANATORIUM A hospital specializing in tuberculosis.
SARCOIDOSIS A chronic disease that may affect the lungs as well as other parts of the body. The cause is not known. The appearance of x-ray films in sarcoidosis may occasionally mimic that seen in tuberculosis.
SCOTOCHROMOGENS Nontuberculous mycobacteria which form pigmented colonies even when grown in the dark (e.g. M. scrofulaceum)
SCREENING Tuberculin skin testing of individuals or groups. It applies only to persons who have not previously been diagnosed as having tuberculosis. The term screening is never used in connection with contact or suspect follow-up.
Georgia Tuberculosis Policy and Procedure Manual 2009

95 SECONDARY DRUGS Refers to antituberculous drugs used in difficult cases such as retreatment or when there is resistance to primary drugs. Examples are Cycloserine (CS), Ethionamide (ETA), Capreomycin (CM) and Streptomycin (SM).
SIGNIFICANT REACTION Reaction to the tuberculin skin test, which suggests the individual tested is infected with tubercle bacilli. A 5mm or greater reaction is classified as significant in HIV persons, recent contacts of a TB case, persons with fibrotic changes on chest radiograph consistent with old healed TB, and clients with organ transplants and other immunosuppressed clients. A 10mm or greater reaction is classified as significant in all other persons having risk factors for TB. A 15mm reaction is classification as significant in persons with no known risk factors for TB. All significant reactions should be recorded in mm and not simply as a positive or significant.
SMEAR (AFB SMEAR) A laboratory technique for visualizing mycobacteria under the microscope. Smear results are usually available within a few days. Positive AFB smears correlate strongly with infectiousness, especially in the untreated clients. However, a "positive" result is not diagnostic of tuberculosis.
SOURCE CASE An infectious individual who has transmitted tubercle bacilli to another person or persons.
SPECIES Identifiable type of organism which predictably reproduces it own kind.
SPUTUM Material coughed up from deep within the lungs. If a client has a pulmonary infection, an examination of the sputum (by smear or culture) can indicate what organism is responsible for the infection. Should not be confused with saliva or with nasal secretions.
STANDARD CHEMOTHERAPY Therapy based on the combination of the three antituberculous drugs: Isoniazid (INH), Rifampin (RIF), and Pyrazinamide (PAZ). Often these are supplemented during the initial phase with either Streptomycin (SM) or Ethambutol (EMB), allowing therapy for many (but not all) clients to be completed in 6 months. A 9-12 month regimen is an acceptable alternative for some clients.
STREPTOMYCIN (SM) The most commonly used injectable antituberculous drug.
SUPERVISED THERAPY See Directly Observed Therapy.
SUPPRESSED CELLULAR HYPERSENSITIVITY (ANERGY) - The impaired or absent ability to react to specific antigens. In tuberculosis diagnostic studies, this condition is sometimes ruled out by use of a panel skin test called an anergy panel. Suppressed hypersensitivity or absence of cellular response to certain antigens is commonly found in clients who are aged, nutritionally unsound, receiving high dosage of corticosteroid, or who
Georgia Tuberculosis Policy and Procedure Manual 2009

96 have had infection from certain viruses. (A reaction of less than 3mm to all antigens is considered anergic).
SUSCEPTIBLE Refers to bacteria which can be killed by the drugs used against them. Also refers to uninfected persons who are at risk of infection or to infected persons who are at risk of developing disease.
SYMPTOMATIC Having symptoms, which may be clues to the presence of tuberculosis or another disease.
TRACHEA The medical name for the "windpipe" which carries air from the throat to the lungs. Tuberculosis present in this area is highly infectious.
TREATMENT FAILURES Refers to an individual who fails to improve even after a course of chemotherapy is begun. It also refers to an individual who relapses after having initially improved.
TRUDEAU American physician who, after having recovered from tuberculosis himself, helped launch the sanatorium movement in this country before the turn of the century.
TUBERCLE BACILLUS Term used to refer to bacillus found in the M. tuberculosis complex M. tuberculosis, M. bovis, M. africanum and M. microti.
TUBERCULIN SKIN TEST (TST) A diagnostic aid for finding M. tuberculosis infection.
TUBERCULOSIS - The disease caused by one of the bacillus in the M. tuberculosis complex. A condition in which tuberculous infection has progressed so that the individual typically has signs and symptoms of illness (cough, fever, anorexia, night sweats), an abnormal x-ray, a "positive" bacteriological examination (smear and/or culture) and possibly a "significant" tuberculin skin test reaction.
TUBERCULOUS INFECTION Condition in which living tubercle bacilli are present in an individual, without producing disease. The infected individual, although having a "significant" tuberculin reaction, usually feels well, has a normal chest x-ray, does not have a "positive" bacteriological examination (smear and culture), and is not infectious. However, the infected individual remains at lifelong risk of developing disease.
TWO-STEP TESTING The procedure of administering two tuberculin tests within one week to three weeks of each other to distinguish a boosted reaction from a reaction caused by recent infection.
Georgia Tuberculosis Policy and Procedure Manual 2009

97 ULTRAVIOLET (UV) LIGHT A form of radiation intermediate between visible light and x-rays. UV radiation is effective in killing many bacteria including tubercle bacilli. May be artificial (from a special light fixture) or natural (from sunlight). VENTILATION Refers to the flow of air into and out of the area surrounding an infectious tuberculosis client. Sufficient air flow dispenses tubercle bacilli and diminishes the risk of transmission of the bacilli. VIRULENCE Refers to the ability of a microorganism such as M. tuberculosis to produce serious disease. Some nontuberculous mycobacteria are virulent (M. kansasii), while other (M. gordonae) are not. WAKSMAN American scientist who discovered Streptomycin (SM). Streptomycin was the first drug found to be effective against tuberculosis. WANING HYPERSENSITIVITY A diminished ability to react to TB antigens to which one has been previously exposed. The lack of response is commonly seen in the older person who, over time, looses a certain percentage of the immune response established at the time of initial exposure to the antigen. ZIEHL-NEELSEN A technique for staining mycobacteria in preparation for examining a sputum smear. The stained mycobacteria appear red against a blue background when viewed under the microscope. XDR-TB See extensively drug-resistant TB
Georgia Tuberculosis Policy and Procedure Manual 2009

98

XVII.

RESOURCES

American Thoracic Society (ATS) and Centers for Disease Control and Prevention (CDC). Diagnostic Standards and Classification of Tuberculosis in Adults and Children. (PDF) Am J Respir Crit Care Med 2000; 161.

ATS/CDC. Update: Adverse Event Data and Revised American Thoracic Society/CDC Recommendations Against the Use of Rifampin and Pyrazinamide for Treatment of Latent Tuberculosis Infection. MMWR 2003; 52 (No. 31)

ATS/CDC. Treatment of Tuberculosis. MMWR 2003; 49 (No. RR-11)

CDC. Core Curriculum on Tuberculosis. Fourth edition, 2000 (1-95).

CDC. Essential Components of a Tuberculosis Prevention and Control Program, MMWR 1995; 44 (No. RR-11).

CDC. Extensively Drug-Resistant Tuberculosis United States, 1993 2006, MMWR, March 23, 2007; 56 (11); 250-253.

CDC. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR 2005; 54 (No. RR-17).

CDC. Guidelines for the Investigation of Contacts of Persons With Infectious Tuberculosis and Guidelines for Using the QuantiFERON TB Gold Test for Detecting Mycobacterium tuberculosis Infection, United States. MMWR 2005; 54 (No. RR-15).

CDC. Interactive Core Curriculum on Tuberculosis: What the Clinician Should Know. October, 2004.

CDC. Mantoux Tuberculin Skin Test: Training Materials Kit (2003).

CDC. Prevention and control of tuberculosis in U.S. communities with at-risk minority populations and prevention and control of tuberculosis among homeless persons. Recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1992; 41(No. RR-5):I-23.

CDC. Protect yourself against tuberculosis. DHHS (NIOSH) publication No. 96-102, December 1995.

CDC. Reported tuberculosis in the United States, 2007. Tuberculosis case rates by state: United States, 2007. September 2008.

Georgia Tuberculosis Policy and Procedure Manual 2009

99 CDC. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. MMWR 2006; 55 (No. RR-14).
CDC. Self-Study Modules on Tuberculosis, Modules 1-5 (2008) Modules 6-9 (2000)
CDC. Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection, MMWR 2000; 49 (No. RR-6): 1-42.
CDC. TB care guide: highlights from core curriculum on tuberculosis. U.S. Department of Health and Human Services. Public Health Service, Centers for Disease Control and Prevention, National Center for Preventive Services, Division of Tuberculosis Elimination, Atlanta, GA. 1994.
CDC. Treatment of Tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR 2003; 52 (No. RR-11) 1-77.
CDC. Tuberculosis Associated with Blocking Agents Against Tumor Necrosis Factor-AlphaCalifornia, 2002-2003. MMWR 2004; 53 (No. 30).
Daugherty-Gibson, J., Field, K., Boutotte, J., & Wilce, M. (2002). Developing a case management model for ensuring completion of TB therapy. The International Journal of Tuberculosis and Lung Disease, 10, S105.
Francis J. Curry National Tuberculosis Center, 2003: DOT Essentials: A Training Curriculum for TB Control Programs
Georgia TB Reference Guide, Atlanta TB Coalition, 2005.
Huff, Parks F. Commitment Procedures For Tuberculosis Treatment. Associate County Attorney, Cobb County Attorney s Office. April 23, 1997.
Iseman, Michael, A Clinician's Guide to Tuberculosis, Lippencott Williams & Wilkins, Philadelphia, PA, 2000.
Kentucky Cabinet for Human Resources Tuberculosis Audit Tool, 1997.
Mississippi State Board of Health, TB Program Manual 1994
New Jersey Medical School Global Tuberculosis Institute, Northeastern Regional Training and Medical Consultation Consortium, Tuberculosis Case Management for Nurses: Self-Study Modules and Facilitator's Guide, May, 2005.
Georgia Tuberculosis Policy and Procedure Manual 2009

100 NTNCC, Tuberculosis Nursing: A Comprehensive Guide to Patient Care, National Tuberculosis Controllers Association, Atlanta, GA, 1997. Occupational Safety and Health Administration. Occupational safety and health standards, subpart 1 personal protective equipment. Respiratory protection. Title 29, Code of Federal Regulations 2003. Section 1910.134. www.osha.gov/pls/oshaweb/owadisp.show_document. Rom, William and Stuart Garay, Tuberculosis, Lippencott Williams & Wilkins, Philadelphia, PA, 2004. South Carolina DHEC Tuberculosis Program Standards and Audit Tool, 1997. Washington State Department of Health, Washington State Tuberculosis Services Manual, updated April 30, 2009 (available at www.doh.wa.gov/cfh/TB/manual/sections).
Georgia Tuberculosis Policy and Procedure Manual 2009

XVIII.

APPENDICES

A. Alternative Housing Project for Homeless Clients

B. Commitment Procedures Templates

C. Mycobacteriology Lab References

D. Policies and Procedures Directly Observed Therapy

E. Policies and Procedures Tuberculin Skin Test

F. Goal Matrix

101
Page 102 Page 119 Page 136 Page 148 Page 164 Page 172

Georgia Tuberculosis Policy and Procedure Manual 2009

102
ALTERNATIVE HOUSING PROJECT FOR HOMELESS TUBERCULOSIS PATIENTS
IN GEORGIA
Operational Procedures
2452 Spring Road Smyrna, Georgia 30080
(770) 434-5864
Georgia Tuberculosis Policy and Procedure Manual 2009

103 Revised August 2008
TABLE OF CONTENTS
Overview Procedures Identify Housing Resources Patient Assessment
Eligibility Financial Assistance Housing Placement without income Housing Placement with income
Administrative Procedures Housing Facility Guidelines Forms
Social Service Referral Patient-Health Department Agreement Temporary Housing Fund Application Patient-Provider Therapeutic Contract Patient-Provider Therapeutic Contract for Financial Assistance Alert Form Monthly Assessment Organizational Chart
Georgia Tuberculosis Policy and Procedure Manual 2009

104
Alternative Housing for Homeless Tuberculosis Patients in Georgia Overview
The closure of the TB Unit at Northwest Georgia Regional Hospital (NWGRH) required public health to identify alternative housing for homeless patients discharged from acute care hospitals within the State of Georgia. These patients, some of whom are infectious, need stable housing in which to receive Directly Observed Therapy (DOT), meals and referrals for social services. Working in collaboration with Metro TB Task Force, the American Lung Association in Georgia (ALAG), Grady Health System and the Atlanta TB Prevention Coalition (ATPC), this plan addresses these public health needs for the statewide TB program.
The Division of Public Health, Epidemiology and Prevention Branch utilized partial funds from the redirection of the closure of the In-Patient Unit at NWGRH to contract with the ALAG to provide alternative housing (including meals, personal supplies, transportation [non TB clinic appointments are coordinated through sub-contracted vendors and MARTA tokens for noninfectious patients] and referrals for social services for the homeless TB patients). Through the contract with ALAG, the Program Director, two Program Coordinators, manage this Project.
More than 749 tuberculosis patients utilized the Alternative Housing Project since 1996. The Project utilizes inexpensive motels, trailers, duplexes, apartments and houses. The health departments provide DOT and transportation to TB and Ryan White clinic appointments. July 1, 2005, American Lung Association of Georgia began to extend its services to provide housing services for non-infectious clients.
The plan to place homeless patients in area housing requires frequent communication among ALAG area hospitals, and county TB clinics. In addition to the formal agreements between ALAG and rental establishments, letters of agreements are on file from all participating districts. These letters demonstrate a commitment to the Alternative Housing Project by each district TB Program. Monthly patient care reviews are mandatory to ensure that continuity of care is maintained and other needed services are being provided. A designated outreach worker (ORW provide DOT and patient follow-up.
Procedures for Alternative Housing Project Purpose:
Funds are provided by the Division of Public Health, Epidemiology and Prevention Branch, TB Section, to the American Lung Association in Georgia (ALAG) to provide assistance for temporary housing and to facilitate Directly Observed Therapy (DOT) to ensure completion of therapy among homeless TB patients.
Georgia Tuberculosis Policy and Procedure Manual 2009

105

Organizational Roles:

ALA of Georgia
Provide technical assistance in locating appropriate housing for 18 health districts Conduct monthly case review with health districts Participate/facilitate multidisciplinary team conferences to maintain patient continuity of care after hospital discharge Establish goals that can be used to measure progress
Preserve and ensure lines of communications

Health District
Assess tuberculosis patients for housing placement and financial assistance Participate in monthly case review with ALAG Provide directly observed therapy and TB medical management

Georgia DHR TB Control Program Consultation
Technical Assistance Administrative Support

Provide transportation to the TB, Ryan White and Infectious Disease clinics Preserve and ensure lines of communications

Disburse Funds
Preserve and ensure lines of communications

Project:

I. The Project will enable homeless TB patients to complete TB therapy by assisting with housing, meals, non-TB clinic transportation substance abuse/mental health referrals and DOT.

II. The ALAG staff will assist the District TB coordinators by identifying temporary housing for appropriate individuals based on medical status and housing needs. Negotiations with potential housing providers must be initiated prior to the identification of homeless patients.

III. ALAG coordinates and approves housing services for the state of Georgia. Funds will be disbursed for housing by check to the leasing agent only. No funds will be issued to the client or family members. The maximum amount allowable at one time is one month's rent. ALAG will not be responsible for paying rent and/or utilities prior to client entering Project. Clients should be evaluated monthly and monthly assessments should be reported to ALAG to determine the continued need for housing services or referrals to other housing programs.

Process: I.

Identify Housing Resources

Georgia Tuberculosis Policy and Procedure Manual 2009

106

Temporary housing may be a motel, hotel, efficiency, apartment, trailer, personal care home or rooming house. Reasonable utilities additionally will be paid, if not included in the rental agreement.

Housing Options * Options include home for patients who can return to a stable home and three levels of facilities for those without a stable home.

Levels of Housing

Level 1:

Acute care hospitals

Alternative Housing Project - smear positive, medically

stable and clinical improving

Level 2:

Shelters ones that require negative smears; trained staffs

provide DOT.

Alternative Housing Project - smear positive, medically

stable and clinical improving

Level 3:

Shelters that require negative cultures (extra-pulmonary

cases); trained staff for DOT

Alternative Housing Project negative cultures (pulmonary

cases)

* Georgia Tuberculosis Reference Guide, 2005. Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, and Georgia Department of Human Resources, Division of Public Health, TB Program, 2005.

II. Patient Assessment

It is the responsibility of the health department to assess all possibilities for housing before requesting assistance through the Project.

A. Eligibility

Patient should be a suspect or an active case of tuberculosis and must demonstrate that he/she has an unstable home environment.

Financial Assistance If a patient is unable to work because of infectiousness, ALAG will assist with monthly financial obligations; this is based on the availability of funds and patient's financial status. Funds will immediately cease once the patient has three negative smears. If a patient is living with a family member, all funds will be distributed to the leasing agent and utility company. ALAG will only pay the patient's portion of rent and/or utilities.
Georgia Tuberculosis Policy and Procedure Manual 2009

107

Housing Placement -without income

Type of

Infectious or Non-

Extra

Latent TB

Placements Status Unknown Infectious

Pulmonary Infection

Hotel

No

Yes

Yes

No Services

(based on

funding

availability)

Motel

Yes

No

Yes

No Services

(infectious status

unknown)

Personal Care

No

Yes

Yes

No Services

Homes

(based on

(based on

medical

medical

condition)

condition)

Rooming

No

Yes

Yes

No Services

House

(based of

funding

availability)

*Food

Yes

Yes

Yes

No Services

*Once a client convert to smear/culture negative. He/she will have 30 days to apply for

the Food Stamp Program. Client MUST provide ALAG written documentation at that

time.

Georgia Tuberculosis Policy and Procedure Manual 2009

108 Housing Placement-with income (including food stamps) not to exceed $500.00

Type of Placements
Hotel
Motel

Infectious or Non- Infectious

Status Unknown

No

Yes

Yes

No

Extra Pulmonary
Yes (based of funding
availability) Yes
(infectious status unknown)

Latent TB Infection No Services
No Services

Personal Care

No

Homes

Rooming House
Food

No
No (ALAG will
provide transportation to store with mask)

Yes (based on medical condition and income amount)
Yes
No (ALAG will
provide transportation to
store)

Yes (based on medical condition and income amount) Yes (based of funding availability) No
(ALAG will provide transportation to store)

No Services
No Services No Services

ALAG has the right to make determinations of eligibility outside the above guidelines.

B. Administrative Procedures

1. The District Health TB Coordinators notifies ALAG, via fax or in Person, with the following completed forms:

A. Alternative Housing/Social Service Referral; B. Patient Health Department Agreement for
Temporary Housing; C. Temporary Housing Fund Application; and D. Patient-Provider Therapeutic Contract; or Patient-
Provider Therapeutic Contract for Financial Assistance.

All forms must be completed and signed by the appropriate persons.

Georgia Tuberculosis Policy and Procedure Manual 2009

109

2. Once the forms have been submitted, ALAG will respond in writing with the approval time and date within 48 hours. Once the time and date have been set, it is the responsibility of the health district to inform ALAG of any change. If both parties have not confirmed a time and date, ALAG will not be responsible for groceries, supplies and/or rent for that day.

THERE ARE NO PLACEMENTS ON FRIDAYS.

3. During the first week, supervised sputums must be collected by the designated health professional three times, thereafter once a week until three consecutive negative. Sputum containers should never be left with the patient nor should the patient receive sputum mailers.

4. For additional funding of current patients, the health districts MUST submit a new Temporary Housing Fund Application along with a Monthly Assessment. It is not the responsibility of ALAG to request additional funding for existing patients. If the necessary paperwork is not submitted, no funds will be disbursed.

5. If the patient misses any DOTs, specimen collections, and/or TB clinic appointments, please complete the Alert Form and submit it to ALAG within 48 hours. Please also submit an Alert Form for any change in the patient's status.

6.

Once the patient is ready for other housing, it is the

responsibility of the Health District to transport patient. Any

patient completing treatment or violating the contract is

responsible for his/her own transportation. A Health District

representative must be present at the time of the move. In

the Metro-Atlanta area, ALAG will meet the Health District

representative at the designated site. All parties must be

there at the agreed time. Keys will be collected by ALAG at

that time.

District Health TB Coordinators MUST adhere to the above protocols to ensure funding in a timely manner to secure patient's retention in this Project.

Georgia Tuberculosis Policy and Procedure Manual 2009

110
Housing Facility Guidelines for Infectious Patients
1. The housing establishment must have prompt availability of housing, a willingness to provide housing and to receive payment on a bi-weekly and monthly basis.
2. The American Lung Association in Georgia and the health districts will provide TB education and skin testing for housing facility staff.
3. The rental unit (motel) must have at a minimum, a bed, table, chair, clothing chest, rack for hangers, refrigerator, stove/microwave and television. The room will be clean and without noticeable pest or odors.
4. The room will have a linen change at least once a week. To minimize the risk of exposure to the hotel staff, the linen should be left for the patient to change.
5. The room will be accessible only from a door leading to the outside, not to a public hallway or another room.
6. The entrance door will have a lock on the inside that the client can set manually and a peephole for safety.
7. The room will have its own toilet, bath or shower with hot running water.
8. The room will have its own independent air conditioner that vents to the outside.
9. The selected motel will have a clean appearance on the outside, excluding areas that are under renovation. Housing Facility Guidelines for Non-Infectious Patients
1. The housing establishment must have prompt availability of housing, a willingness to provide housing and to receive payment on a biweekly and monthly basis.
2. The rental unit (hotel, motel, personal care home or a rooming house) must have at a minimum, a bed, a clothing chest, and a rack for hangers. The room will be clean and without noticeable pest or odors.
3. The housing site must be at least within walking distance of a laundry mat or on the bus route.
4. The entrance will have a lock on the inside that the client can set manually and a peephole for safety.
5. The room will be accessible to a toilet, bathroom with hot running water.
6. The selected housing facility will have a clean appearance on the outside, excluding areas that are under renovation.
Georgia Tuberculosis Policy and Procedure Manual 2009

111
Forms
Georgia Tuberculosis Policy and Procedure Manual 2009

112

SOCIAL SERVICES REFERRAL
TB Alternative Housing Project

Patient'sName:________________________________County/District:_______________ Age:________

Race:__________

Gender: Female

Male

Previous/CurrentAddress:____________________________________________________ Address Was:

Street Shelter* Abandoned Building Family/Friends Home

*Name of Shelter__________________________________________________

Reason for services:________________________________________________________

*************************************************************************

Lab Status: (Must have lab work to process referral)

Smear

Culture

Case

1+

2+

3+ 4+

No Growth MTB Atypical

Type of specimen:___________

Suspect 1+ 2+ 3+ 4+

Pending at ________weeks

Expected TB Completion Date:____/____/___ Site of TB____________________________

Chest x-ray Status:

Abnormal Normal Date:____/___/____

*************************************************************************

Mental Health Status

Past Psychiatric History

Yes

No

Diagnosis (where, when, name of Doctor/Therapist) ______________________________

*************************************************************************** Income Status:

Employment (Where)_______________________________$_______

Can Patient return to work

Yes No

Food Assistance

$_______

General Assistant

$_______

SSI Disability

$_______

TANF

$_______

Veterans Benefits

$_______

TOTAL MONTHLY INCOME

$_______

***************************************************************************

Substance Abuse:

Alcohol

Amphetamine Cocaine

Crack IV Drug

Marijuana

Denied

***************************************************************************

Services Requested:

Housing

Food Funds for Rent/Utilities

Social Services

***************************************************************************

Anticipated move-in date:_________ TB Representative:_______________________

Date________________

*************************************************************************

For ALAG Use Only

Approved

Denied

___________________________________________

Signature and Date

Move in Date:___________________________

All sections must be completed in its entirety to be processed.

Georgia Tuberculosis Policy and Procedure Manual 2009

113
PATIENT-HEALTH DEPARTMENT AGREEMENT FOR TEMPORARY HOUSING
TB Alternative Housing Project
I, ____________________certify that I have no fixed, regular, and/or adequate residence at this time and I am unable to provide shelter for myself. I understand that I have (confirmed or suspected) active TB disease and treatment is necessary. I understand that, at this time, I am (infectious or not infectious) to others. I understand that District Public Health and the _________ will provide temporary housing during treatment and I must: 1. Be at ____________ on ___________ at ___________ am/pm to take my medicine. 2. Keep clinic appointments and have laboratory tests as necessary. 3. Notify the TB nurse of any problems with TB medicine or other emergencies. 4. Avoid alcohol and/or other drug use. 5. Not to participate in any illegal activity at the residential facility. 6. Not visit with other people in the housing area or other indoor areas until the TB nurse tells me I am not
infectious to others. 7. Follow lease conditions by not having anyone else stay overnight, unless pre-approved in the lease. 8. Not to make any charges to the housing; and not make any long distance phone calls charged to the
housing. 9. Allow the health department to identify me by name to the housing agent if needed. 10. Will hold the American Lung Association in Georgia its agents from any and all liability.
I understand that if I violate any of the above, I may lose the housing and I may be confined to another appropriate facility to complete my TB disease treatment.
Client: ______________________________TB Representative: _________________________
Date: _____________________
****************************************************************************** The housing agent hereby agrees to comply with the following and thereby, will hold harmless the American Lung Association in Georgia and its agents from any and all liability. Infectious Patients: 1. Provide housing that meets infection control guidelines. 2. Provide housing with an exit that leads directly to the outside or to a hallway that leads directly outside. 3. Provide single occupancy housing and will report TB patient violations to the TB representative and
ALAG. 4. Allow no housing employee to enter the client's room until 24 hours after the client is determined to be
noninfectious by the TB nurse. Housekeeping and linen supply arrangements are as follows: _____________________________________________________________________________
Non-Infectious Patients: 1. Provide single occupancy housing and will report TB patient violations to the TB representative and ALAG. 2. Provide TB patient with clean linen at least once a week if patient is residing at a hotel, motel or a personal care home. Clients residing at a rooming house will be responsible for their own linen.
Housing Agent: _____________________ TB Representative:_____________________________
Date: __________________________________
Georgia Tuberculosis Policy and Procedure Manual 2009

114

TEMPORARY HOUSING FUND APPLICATION
TB Alternative Housing Project

Patient's Name:

Address:

******************************************************************************* TB Coordinator Name:

District:

Health Department:

Address:

County:

Telephone #:

Fax #:

*******************************************************************************

Housing Vendor:

Federal ID Number:

Contact Person:

Address:

County:

Telephone #: Fax #:

Charges for Housing

$ ________ $ ________ $ ________

Monthly from ________to_________ Bi-weekly from ________to_________ Weekly from ________to_________

*******************************************************************************
Signature of TB Representative: __________________________ Date: __________________

Signature of Housing Vendor: ____________________________Date: _________________

*If there is not a vendor signature, Coordinator must provide official documentation of the amount and
address.

All Sections must be completed in its entirety to be processed.

Georgia Tuberculosis Policy and Procedure Manual 2009

115
PATIENT-PROVIDER THERAPEUTIC CONTRACT TB Alternative Housing Project
The following is a statement of what is expected of each patient who agrees to accept temporary housing paid for by the American Lung Association in Georgia. Please read guidelines carefully and if you agree to abide by the conditions listed, please sign at the bottom.
1. Lodging will be temporarily provided for you during your treatment for TB. The length of time the room will be made available to you will depend on your medical needs, your cooperation and continued participation with follow-up provided by District Public Health.
2. During your stay, you are expected to keep your room clean and undamaged. At the end of your stay, the room must be left in good condition.
3. You should have no visitors at any time. 4. If it is determined that you need food assistance, food vouchers/certificates may be
made available to you so that your family or friends may purchase food for you. 5. You must remain in your room until District Public Health informs you otherwise. 6. Your outreach worker or nurse will visit with you once a day, usually in the morning.
Other unannounced visits will be made. 7. Participation in Directly Observed Therapy (DOT) is required in order to stay at the
residential facility. DOT will be provided to you by a designated health care professional. Failure to participate in a scheduled DOT session, may lead to the immediate termination of your room rental. As a part of your treatment, you may be transported from time to time to the Health Department for test, or to see physicians. 8. Use of illegal drug or other illegal activities by you and/or any guest(s) in your room will result in the immediate termination of your room rental. 9. Any behavior deemed detrimental and or inappropriate (determined by ALAG, the District Public Health and/or the vendor) to your health, the health of others or the property will result in the immediate termination of your room rental. 10. If your room rental is terminated due to inappropriate behavior by you or your guest(s) or by your inability to comply with DOT, you must return the room key immediately to the outreach worker, TB nurse or designated staff and vacate the premises. 11. If you are diagnosed as not having TB, you will be released from the Project within 48 hours. 12. ALAG will seek, when possible, to involve and educate family and friends in your aftercare so that they will have a better understanding of how to assist you while you are in the motel and later when you are able to find alternate housing.
Signature: ______________________________ Date: __________________________
Georgia Tuberculosis Policy and Procedure Manual 2009

116
PATIENT-PROVIDER THERAPEUTIC CONTRACT For Financial Assistance
TB Alternative Housing Project
The following is a statement of what is expected of each patient who agrees to accept financial assistance for (name services) _______________________________________ paid for by the American Lung Association in Georgia. Please read guidelines carefully and if you agree to abide by the conditions listed, please sign at the bottom.
1. The length of time that ALAG will provide financial assistance will be determined by any financial changes, your medical needs, your cooperation and continued participation with follow-up provided by District Public Health.
2. You should not have visitors until Public Health informs you that you are no longer infectious to others. At that time visitors must wear a mask.
3. Your TB representative will visit with you weekly. Other unannounced visits will be made.
4. Participation in Directly Observed Therapy (DOT) is required in order to receive financial assistance. DOT will be provided to you by a designated health care professional. Failure to participate in a scheduled DOT session may lead to the immediate dismissal from the Project. As a part of your treatment, you may be transported from time to time to the Health Department or another site for tests or to see physicians.
5. Any behavior deemed detrimental to your health or the health of others will result in the immediate termination of the agreement.
6. If you or your inabilities to comply with DOT terminate the agreement due to inappropriate behavior, ALAG will immediately cease from providing financial assistance.
7. When you have completed the project or have three negative smears, ALAG will immediately cease from financial assistance.
8. If you are diagnosed as not having TB, ALAG will immediately cease financial assistance.
9. We will seek, when possible, to involve and educate family and friends in your aftercare so that they will have a better understanding of how to assist you while you are enrolled in the Project.
Signature: ________________________________ Date: _________________________
Georgia Tuberculosis Policy and Procedure Manual 2009

117
ALERT FORM TB Alternative Housing Project Date: ______________________
Patient's Name: Location:_________________________________________________________________ Date of field visit: __________________________________Time: __________________ Name of person conducting field
visit:___________________________________________________
Reason for field visit: Collect Sputum DOT Transportation to TB Clinic Routine visit Other
*******************************************************************************
Reason for Alert: Patient not at designated site Patient was hospitalized Patient refused DOT Patient has unauthorized visitors Patient left Project Patient incapable of living along
Concerns: _________________________________________________________________________ _________________________________________________________________________ Plan of Actions: _________________________________________________________________________ _________________________________________________________________________
Submitted by:___________________________________________Date:_______________________
Note: Form must be faxed to American Lung Association in Georgia's Alternative Housing Project within 48 hours of the event. Fax: (770) 319-0349, Office (770) 434-5864
Georgia Tuberculosis Policy and Procedure Manual 2009

118

MONTHLY ASSESSMENT TB Alternative Housing Project

MONTH: ________________

PATIENT'S NAME: ___________________________ DATE OF BIRTH: __________________

ADDRESS:______________________________________________________________________

COUNTY OF RESIDENCE:_______________________DISTRICT: _______________________

LAST CLINIC EVALUATION:______________ANTICIPATED CLOSURE DATE:__________

*******************************************************************************

LAB STATUS:

DATE

SMEAR

CULTURE

(Please check box)

(Please check box)

1. _________ - 1+ 2+ 3+ 4+

No Growth MTB Pending

2. _________ - 1+ 2+ 3+ 4+

No Growth MTB

Pending

3. _________ - 1+ 2+ 3+ 4+

No Growth MTB

Pending

4. _________ - 1+ 2+ 3+ 4+

No Growth MTB

Pending

5. _________ - 1+ 2+ 3+ 4+

No Growth MTB

Pending

6. _________ - 1+ 2+ 3+ 4+

No Growth

MTB Pending

How Results Obtained:

Sputum

Culture

Induced

Other

(Please Check Appropriate Boxes)

*******************************************************************************

CURRENT TREATMENT REGIMEN - DOT:

Daily

Biweekly

3x weekly

Total Number of DOT's ________________

(for the entire month)

If DOT's missed, please give explanation:

_____________________________________________________

Number Delivered: _________

Number Taken/Observed _________

*******************************************************************************

PATIENT PHYSICAL STATUS: Full time Part time Not able to work

SUMMARY/RECOMMENDATIONS: ___________________________________________ Submitted by: __________________________________ Date: _______________________

All sections must be completed before submitting Monthly Assessment Form.

Georgia Tuberculosis Policy and Procedure Manual 2009

119 APPENDIX B COMMITMENT TEMPLATES 1. Commitment Order 2. Consent Commitment Order 3. Emergency Commitment Hearing Order 4. Emergency Petition for Confinement of Tuberculosis Client 5. Modification of Consent Commitment Order 6. Physician's Certification for Tuberculosis Confinement 7. Verification
Georgia Tuberculosis Policy and Procedure Manual 2009

120

COMMITMENT FOR TUBERCULOSIS TREATMENT

IN THE SUPERIOR COURT OF ________________ COUNTY

STATE OF GEORGIA

COUNTY

*

BOARD OF HEALTH

*

*

Plaintiff,

_________________________,

*

CIVIL ACTION

*

v.

*

FILE NO.

*

_________________________,

*

*

Defendant,

*

COMMITMENT ORDER

The Plaintiff having filed a Petition for Commitment to a hospital of a client with active tuberculosis on _____________, 200___, the Court having appointed a hearing officer to hear the Plaintiff's Petition and counsel to represent the Defendant, the Plaintiff and the Defendant having agreed to the following Consent Order for Confinement and the hearing officer having agreed to this Consent Order; the hearing officer finds the following:
The Defendant, _________________________, is a _____-year old male/female who has active tuberculosis as defined by O.C.G.A.31-14-1. From 200___, the Defendant was under the supervision of the _____________ Board of Health's Tuberculosis Clinic for treatment of his/her active tuberculosis. During this time, the Defendant did not comply with Board of Health orders to consistently take his/her medication and remain confined so that he/she would not spread the disease. The inconsistent treatment of tuberculosis poses the risk to _________________________ and the general public of creating a resistant tuberculosis strain that would not be treatable for

Georgia Tuberculosis Policy and Procedure Manual 2009

121

the Defendant or for any person who might contract this resistant strain. Since the Defendant's involuntary confinement on ______________________, 200__, at ___________________ , the Defendant's tuberculosis has responded to treatment and the level of bacteria in his/her sputum has reduced dramatically. Although he/she shortly will become non-infectious for active tuberculosis, he/she would subject himself/herself to a relapse if the tuberculosis treatment were not continued for the length of time as prescribed by his/her physician, which could result in a resistant or multi-resistant tuberculosis strain.
Based upon the above-described facts, the hearing officer hereby finds that the Defendant should remain confined to a facility that will ensure that he/she consistently takes his/her medication for active tuberculosis. The period of confinement shall be for six (6) months unless an extension of the confinement is granted pursuant to O.C.G.A.3114-8.1. The place of confinement shall be _______________________, a facility that has been approved by the Department of Human Resources for the care of tubercular clients. The Defendant's confinement at _____________________ shall begin only after the Defendant no longer has active tuberculosis as determined by his/her physician. While the client still has active tuberculosis, he/she shall remain confined at _____________________ under the __________________ County Sheriff's supervision. When it is determined that he/she no longer has active tuberculosis, the Sheriff of ______________ County or his/her deputies will transport the client to ___________________ in ________________, ________________, and release him/her into the custody and care of _____________________.
SO FOUND this ________ day of __________________, 200___.

____________________ Consented to and approved by:

_____________________________________ Hearing Officer appointed by Superior Court Judge

Georgia Tuberculosis Policy and Procedure Manual 2009

122 ___________________________________ Attorney for Defendant ____________________________________ Attorney for Plaintiff ____________________________________ Defendant
Georgia Tuberculosis Policy and Procedure Manual 2009

123

IN THE SUPERIOR COURT OF ________________ COUNTY STATE OF GEORGIA

COUNTY

*

BOARD OF HEALTH

*

*

Plaintiff,

*

*

v.

*

*

_________________________, *

*

Defendant,

*

CIVIL ACTION FILE NO.

CONSENT COMMITMENT ORDER

The hearing officer that was appointed by this Court having approved a Consent Commitment Order for the confinement of the Defendant, this Court hereby approves the Commitment Order that was entered into by the hearing officer on the _____ day of ________________, 200___.
THEREFORE, the Defendant is ORDERED to be confined pursuant to O.C.G.A.31-14-1, et seq., and to____________________ for a period of _____ (__) months to ensure that he/she regularly takes his/her tuberculosis treatment. While at _____________________, the Defendant will comply with all the orders of ____________________________for the treatment of tuberculosis, Board of Health orders regarding his/her treatment for tuberculosis, and the orders of medical professionals whose care he/she is under. The Defendant's confinement for the treatment and care for his/her disease shall not exceed ______ (____) months, unless that time period is extended by hearing as provided in O.C.G.A.31-14-8.1. The Defendant's confinement at ___________________ shall begin only after he/she is negative for active tuberculosis.

Georgia Tuberculosis Policy and Procedure Manual 2009

124 Until the Defendant is negative for active tuberculosis, he/she shall remain in the custody of the __________ County Sheriff or his/her lawful deputies at ___________________ Hospital.
SO ORDERED this ________ day of __________________, 200___. _____________________________________ Judge Superior Court _________________ County
Prepared and presented by: ___________________________________ Attorney for _________________ Approved by: ____________________________________ Attorney for __________________ ____________________________________ Defendant
Georgia Tuberculosis Policy and Procedure Manual 2009

125

IN THE SUPERIOR COURT OF ___________________ COUNTY

STATE OF GEORGIA

___________ COUNTY

*

BOARD OF HEALTH

*

*

Plaintiff,

*

*

v.

*

*

______________________

*

*

Defendant,

*

CIVIL ACTION FILE NO. ________________

EMERGENCY COMMITMENT HEARING ORDER

The Plaintiffs' Emergency Petition for Confinement of Tuberculosis Client having come before this Court, and after hearing ex parte evidence presented by the Plaintiff, the Court finds the following:
1. The Defendant, ______________, has active tuberculosis.
2. The Defendant has violated the _______________ County Board of Health orders to remain confined in the Defendant's residence and has further defied the Board of Health orders to consistently take his/her medicine.
3. The Defendant poses a flight risk because (state documented basis for allegation -he/she does not have a stable address, has a drug problem, is used to living on the streets).
4. Based upon the above listed conclusions, the evidence presented to the Court and the Physician's Certificate attached to the Plaintiffs' Petition, and the verified Petition, the Court holds the following:

Georgia Tuberculosis Policy and Procedure Manual 2009

126

a. Because the Defendant may abscond or conceal himself/herself and because

his/her violation of Board of Health orders makes him/her a substantial risk

of exposing other persons to an imminent danger of infection, the Court

directs the Sheriff or his/her deputies to take the Defendant into custody

pending the hearing that is required pursuant to O.C.G.A. 31-14-3. This

shall be under the supervision of Board of Health personnel or other

medical personnel to ensure the safety of the Sheriff's deputies.

b. The Defendant shall remain in custody untilhe/she has a full and fair

hearing on the Plaintiffs' Petition for Confinement. This initial confinement

shall be at a facility appropriate for TB treatment.

c. The Court hereby sets a hearing date on the Plaintiffs' Petition for the

_______ day of _______________, 200 at ______ __. The hearing shall

be conducted at __________________________.

d.

is entitled to appointed counsel. The Court will

appoint counsel unless

indicates in writing he/she

does not want counsel. The Court hereby

appoints_____________________ as Counsel for the Defendant to

represent him/her in this matter.

e. During the Defendant's initial confinement pursuant to this Order, the

Defendant shall remain confined so that he/she does not infect the general

public with tuberculosis and he/she shall take his/her medications as

directed by the Board of Health and any health professional whose care

he/she is under.

f. The Defendant shall further submit himself/ herself to appropriate medical

examinations to determine whether and when the tuberculosis is no longer

active.

Georgia Tuberculosis Policy and Procedure Manual 2009

127

SO ORDERED this ______ day of ______________________, 200.

County

__________________________________ _____________________, Judge Superior Court of

Prepared and Presented by:

_______________________ Attorney for Plaintiff Ga. Bar No. _____________

Georgia Tuberculosis Policy and Procedure Manual 2009

128

IN THE SUPERIOR COURT OF_______________ COUNTY

STATE OF GEORGIA

______________ COUNTY

*

BOARD OF HEALTH

*

*

Plaintiff,

*

*

v.

*

*

__________________________ *

*

Defendant,

*

CIVIL ACTION FILE NO. ________________

EMERGENCY PETITION FOR CONFINEMENT OF TUBERCULOSIS CLIENT

COMES NOW, the _____________ COUNTY BOARD OF HEALTH to file this Petition for Commitment of a Person with Active Tuberculosis pursuant to O.C.G.A. 31-14-1, et seq., and shows the Court as follows;
1. The Defendant, _____________________, resides at ___________________________ in ________________ County, and is therefore subject to the jurisdiction of this Court.
2. The Defendant has active tuberculosis as defined in O.C.G.A. 31-14-1(a).
3. The Defendant is violating orders of the Department regarding treatment of his/her active tuberculosis having missed _____ (_____) out of his/her last _____ (___) scheduled doses. The Defendant has also violated specific Board of Health orders by not confining himself/herself to his/her residence, thus exposing himself/herself to the general public.
4.

Georgia Tuberculosis Policy and Procedure Manual 2009

129

The Defendant, by violating these orders of the Board of Health presents a substantial risk

of exposing other persons to an imminent danger of infection. The Defendant was released

from ____________________ Hospital on _____________, 200__, with active

tuberculosis and was referred to the ___________ County Board of Health Tuberculosis

Clinic for follow-up treatment.

5.

The Defendant's chest x-ray and medical examinations and sputum

examination confirm that the Defendant has active tuberculosis. The state medical lab has

confirmed the sputum test.

6.

The general public's health requires commitment of this person to prevent

exposing the general public to tuberculosis.

7.

The Defendant was formerly a homeless person, but since his/her release

from ____________ Hospital, has resided with _____________________ at

_______________________. This person may be unaware of their risk for TB infection

due to continued contact with the Defendant therefore screening may be necessary.

Because he/she has no stable address, the Defendant presents a risk of concealing

himself/herself from the ___________ County Board of Health. He/She has also

conducted himself/herself in a manner to expose the general public by disregarding the

Board of Health orders to remain confined in ______________________'s house and to

regularly take his/her medication.

8.

Because the Defendant is a flight risk and is conducting himself/herself in a

manner to expose others to imminent danger of infection, emergency commitment is

necessary to protect the general public.

WHEREFORE, the Plaintiff respectfully requests that this Court Georgia Tuberculosis Policy and Procedure Manual 2009

130

a. Direct the Sheriff or Sheriff's Deputies to take the Defendant into Custody pending a hearing on the Petition for Confinement so he/she will not endanger other persons pursuant to O.C.G.A. 31-14-5. b. That the Court schedules a hearing no sooner than ________ (__) days and no later than
_____________ (__) days to determine whether the Defendant should be confined. c. That the Court appoints the Defendant counsel to represent him/her at this hearing. d. That the Court give the Plaintiff such further relief as the Court deems necessary.
Respectfully submitted,

Address Phone Number

______________________ ______________________ Attorney for Plaintiff Ga. Bar No. ____________

Georgia Tuberculosis Policy and Procedure Manual 2009

131 IN THE SUPERIOR COURT OF_____________ COUNTY
STATE OF GEORGIA

COUNTY BOARD OF HEALTH, Petitioner
v. ___________________________,
Respondent.

* CIVIL ACTION * * * FILE NO. _______________ * * * * *

MODIFICATION OF CONSENT COMMITMENT ORDER
The Plaintiff and the Defendant having come before this Court with a Consent Modification of this Court's Consent Commitment Order dated ________________, 200__, the Court hereby amends its Order of _________________, 200___, as follows:
1. The ___________ County Sheriff is relieved of his/her responsibility of maintaining the Defendant in his/her custody at _______________ Hospital until further order of this Court. The ______________ County Sheriff or his/her lawful deputies are still responsible for transporting the Defendant to ________________ in __________, __________. No other terms of the Consent Commitment Order or the Commitment Order of the hearing officer is altered or amended or superseded by this amendment.
_____________________________________ Judge, ____________ County Superior Court

(Signatures continued on following page.)

Consented to by:
______________________________ Attorney for Plaintiff
Georgia Tuberculosis Policy and Procedure Manual 2009

132 Ga. Bar No. _______ _______________________________ Attorney for Defendant Ga. Bar No. _________
Georgia Tuberculosis Policy and Procedure Manual 2009

133 IN THE SUPERIOR COURT OF _________COUNTY

STATE OF GEORGIA

____________COUNTY

*

BOARD OF HEALTH

*

*

Plaintiff,

*

*

v.

*

*

_______________________

*

*

Defendant,

*

CIVIL ACTION FILE NO. ________________

PHYSICIAN'S CERTIFICATION FOR TUBERCULOSIS CONFINEMENT COMES NOW, _________________, M.D., who after being duly sworn states
the following: 1.
Affiant is a Physician licensed to practice medicine in the State of Georgia and is the Primary Physician for the Defendant.
2. The Defendant is a _____ year old man/woman with presumptive active tuberculosis (TB). This diagnosis is based upon a physical examination of the client and reviewing _______________'s medical records, including his/her chest x-ray, which shows an anomaly, and positive AFB sputum smears.
3. The client should be strictly monitored to ensure that he/she takes his/her medication for the TB as prescribed to ensure his/her infection is not infectious and that he/she does not develop drug-resistant TB.
4. Since _______________'s TB is contagious, he/she should be confined so he/she does not come into contact with the general public. FURTHER AFFIANT SAYETH NOT.
Georgia Tuberculosis Policy and Procedure Manual 2009

Sworn to and subscribed before me this _________day of ___________________, 200___.
______________________________ NOTARY PUBLIC
[SEAL]

134 ______________________________
Print Physician Name

Georgia Tuberculosis Policy and Procedure Manual 2009

135 STATE OF _____________
COUNTY OF

VERIFICATION _________________, DIRECTOR, TB CLINIC, ________________ COUNTY BOARD OF HEALTH being first duly sworn on oath, deposes and says that he/she is the Coordinator of the TB Clinic for the ________________ County Board of Health, that he/she has read the foregoing Emergency Petition for Confinement of Tuberculosis Client and knows the contents thereof, and that the contents of the Petition are true and correct to the best of his/her knowledge.

Sworn to and subscribed before me this _________day of ________________, 200___.

_______________________________

DIRECTOR OF

_ COUNTY

BOARD OF HEALTH

________________________________ NOTARY PUBLIC
[SEAL]

Georgia Tuberculosis Policy and Procedure Manual 2009

136
APPENDIX C
Mycobacteriology Lab Tests
Quick Reference Sheets
April 2009
7H11 Agar Plate Acid-Fast Stain Genotyping Gen-Probe HPLC LJ Slants MGIT MTD PCR RFLP Susceptibilities
Georgia Tuberculosis Policy and Procedure Manual 2009

137 7H11 Agar Plate

How does it work? When would this media be used?

7H11 agar is a transparent agar-based media for the isolation and colony morphology of mycobacteria. Oleic acid, albumin, and pancreatic digest of casein are the key ingredients which aid in the growth of the tubercle bacilli.
When a broth culture exhibits growth, the laboratory uses this media to obtain growth of the mycobacteria on solid media.

How long before growth is obtained?

Visible growth can occur in as few as 3 to 5 days with the rapid-growing mycobacteria. With M. tuberculosis, and some of the other slow-growing bacteria, it can take up to 4 weeks before growth is obtained.

How are the results classified?
What do the results mean?
Are other tests needed? How would this test be ordered? How much would this test cost?

Positive for growth Negative for growth Contaminated
When growth is observed on the 7H11 media, the technologist determines if the growth is a mycobacterium species or if it is some other organism. If the growth is a mycobacterium species, identification procedures are started. If the growth proves to be an organism other than a mycobacterium, then the plate is considered to be contaminated and no further studies are performed. If no growth is seen on the 7H11 agar, it is reported as negative.
The TB Lab will initiate identification procedures if the growth is a mycobacterium species.
NA
The GA Public Health Laboratory does not charge the county or the district for this procedure.

Georgia Tuberculosis Policy and Procedure Manual 2009

138 Acid-Fast Stain (AFB Smear)

How does it work?

Mycobacteria are able to form stable complexes with certain stains such as Auramine O. Although the exact nature of the acid-fast staining reaction is not completely understood, phenol in the primary stain allows the stain to penetrate into the cell wall. The cell wall mycolic acids retain this primary stain even after washing with acid-alcohol. This resistance to decolorization with acid-alcohol is what causes mycobacteria to be called "acid-fast."
A drop of processed sputum is spread on a microscope slide and placed on a 70 C slide warmer for 2 hours.
The slide is then moved to a staining rack and Auramine O stain is applied to the slide for 15 minutes.
The slide is washed with acid-alcohol for 2 minutes. Acridine orange, a counterstain, is applied to the slide for 2 minutes. The slide is then rinsed with distilled water, allowed to air dry, and
examined using a fluorescent microscope.
Mycobacteria appear as green fluorescing bacilli against a red-orange background.

When is this test run? How long before results are ready?
How are the results classified?
What do the results mean? Are other tests needed? When would this test be used? How would this test be ordered? How much would this test cost?

Monday through Friday Results are usually available within 24 hours.

Number of bacteria seen No fluorescing bacteria seen 1-3 fluorescing bacteria seen on entire slide 4-36 fluorescing bacteria seen per 100 fields 4-36 fluorescing bacteria seen per 10 fields 4-36 fluorescing bacteria per field >36 fluorescing bacteria per field

Interpretation No AFB found +/1+ 2+ 3+ 4+



The higher the number (4+), the higher the bacterial load.



The higher the number, the more infectious the patient is to others.



Begin TB treatment with 4 drugs until TB is confirmed or ruled out.



Any patient with a positive AFB smear needs to be on respiratory

isolation.

Yes, a culture and sensitivity if the culture grows MTB.

To quickly determine if TB is a possibility. To determine the degree of infectiousness.

This test is automatically done on all clinical specimens.
The GA Public Health Laboratory does not charge the county or district for this test.

Georgia Tuberculosis Policy and Procedure Manual 2009

How does it work?
When is this test run? How long before results are ready? How are the results classified? What do the results mean? Are other tests needed? When would this test be used?
How would this test be ordered? How much would this test cost?

139 Genotyping
The genotype of an organism refers to the specific genetic makeup of that organism, usually in the DNA. This "internally coded, inheritable information" is used as a blueprint or set of instructions for building and maintaining a living creature. These instructions are written in a coded language (the genetic code) and they are copied at the time of cell division or reproduction and are passed from one generation to the next. Genotyping describes a great variety of techniques that are used to identify the primary localization and mapping of genes.
The State Lab does not perform this test. Isolates are sent to the Michigan State Genotyping Lab for analysis.
Results are usually available 2 to 4 weeks after the Michigan State Genotyping Lab receives the isolate.
NA
The results show a mapping of the gene.
NA
To rule out cross-contamination of specimens. To determine reactivation vs. reinfection of a patient. To determine if two or more patients are infected with strains of
M. tuberculosis possessing identical genotypes.
Isolates on all first-time MTB positive patients are automatically sent to Michigan for genotyping. Physicians can request this test by calling the Georgia Public Health TB Lab.
There is no charge for this test.

Georgia Tuberculosis Policy and Procedure Manual 2009

140 Gen-Probe AccuProbe DNA Probe Test (Gen-Probe)

How does it work?
When is this test run? How long before results are ready? How are the results classified? What do the results mean? Are other tests needed? When would this test be used? How would this test be ordered? How much would this test cost?



The Gen-Probe identification test is a rapid DNA probe test

which uses nucleic acid hybridization for the identification of certain

mycobacteria. Gen-Probe manufactures four Accuprobe kits to test

for the following organisms: M. tuberculosis complex, M. avium

complex, M. gordonae, and M. kansasii.



Ribosomal RNA is released from the test organism by sonication.

A single-stranded DNA probe (specific for the target* organism) with

a chemiluminescent label combines with the ribosomal RNA to form

a DNA:RNA hybrid. The hybrids are then measured in a

luminometer. Results are measured in relative light units.

This test serves as a "back up" for HPLC testing and is only run when the HPLC instrument is broken
Results are available the day the test is run.
Positive, Negative, and Indeterminate for the target organism.
Positive: The isolate is identified as one of the target organisms. Indeterminate: The test is inclusive and must be repeated. Negative: The isolate is not one of the target organisms.
If the isolate is identified as M. tuberculosis, and if this is the first time the patient has had a positive MTB culture, then a susceptibility should be ordered. This is automatically done by the TB Lab.
To identify growth on solid media or growth in liquid media as M. tuberculosis complex, M. avium complex, M. kansasii, or M. gordonae.

This test is ordered by the TB laboratory technologists when it is indicated.
The GA Public Health Laboratory does not charge the county or the district for this test.

* The target organism is the organism the test kit is designed to identify. For example, if you were using the
Accuprobe M. kansasii test kit, the target organism would be M. kansasii.

Georgia Tuberculosis Policy and Procedure Manual 2009

How does it work?

141
High-Performance Liquid Chromatography (HPLC)
HPLC is used to identify mycobacteria by analysis of mycolic acids. Mycobacteria contain large amounts of mycolic acids in their cell wall. The type and amount of the mycolic acids vary in each species of mycobacteria. HPLC testing generates chromatographs based on the mycolic acids that are present in the test organism. By comparing these graphs with know reference chromatograph patterns, the organism can be identified.

When is this test run?

Monday through Friday

How long before results are ready? How are the results classified? What do the results mean? Are other tests needed? When would this test be used? How would this test be ordered? How much would this test cost?

Results are available the day after the testing is performed.
HPLC testing should identify the mycobacterium being tested.
N/A If the organism is identified as M. tuberculosis, and if this is the first time MTB has been isolated from the patient, then a susceptibility needs to be ordered (done automatically by the TB Lab). To identify an isolate as a mycobacterium.
This test is ordered by the TB laboratory technologists when it is indicated. The GA Public Health Laboratory does not charge the county or the district for this test.

Georgia Tuberculosis Policy and Procedure Manual 2009

142 Lowenstein-Jensen Agar (LJ Slants)

How does it work?

Lowenstein-Jensen agar is a relatively simple formulation that requires the addition of supplements in order to support the growth of mycobacteria. Glycerol and egg mixture are added to provide the fatty acids and protein which are required for the metabolism of mycobacteria.

When would this agar be used? How long before growth is obtained? How are the results classified?
What do the results mean?
Are other tests needed? How would this test be ordered? How much would this test cost?

After undergoing the decontamination/concentration process, all specimens received in TB Lab for routine culture are inoculated onto this media.
Visible growth can occur in as few as 3 to 5 days with the rapid-growing mycobacteria. With M. tuberculosis, and some of the other slow-growing bacteria, it can take up to 4 weeks before growth is obtained.
Positive for growth Negative for growth Contaminated
When growth is observed on the LJ slant, the technologist determines if the growth is a mycobacterium species or if it is some other organism. If the growth is a mycobacterium species, identification procedures are started. If the growth proves to be an organism other than a mycobacterium, then the LJ is considered to be contaminated and no further studies are performed. If no growth is seen on the LJ slant, it is reported as negative.
The TB Lab will initiate identification testing. Susceptibilities will be ordered by the lab when indicated.
NA
The GA Public Health Laboratory does not charge the county or the district for this procedure.

Georgia Tuberculosis Policy and Procedure Manual 2009

How does it work?

143
Mycobacteria Growth Indicator Tube (MGIT)
The MGIT Tube is intended for the detection and recovery of mycobacteria using the BACTEC 960 equipment. The tubes contain 7 ml of modified Middlebrook 7H9 broth and are flushed with 10% CO2.
A fluorescent compound is embedded in silicone on the bottom of the round bottom MGIT tubes. The fluorescent compound is sensitive to the presence of oxygen dissolved in the broth. Initially, the large amount of dissolved oxygen quenches emissions from the compound and little fluorescence can be detected. Later, actively growing organisms consume the oxygen and allow the fluorescence to be detected.
Tubes are monitored by the BACTEC 960 every 60 minutes for increasing fluorescence. Analysis of the fluorescence is used to determine if the tube is positive.

When would this media be used?
How long before growth is obtained? How are the results classified? What do the results mean? Are other tests needed? How would this test be ordered? How much would this test cost?

MGIT tubes are innoculated each day that clinical specimens are received in the lab. After undergoing the decontamination/concentration process, all specimens received for routine culture are inoculated onto this media.
For mycobacteria, from 1 week to 6 weeks. Negative (no growth) MGITs are held for 6 weeks before reporting as negative.
Positive, Negative, or Contaminated
Positive: Growth noted. Identification procedures are started. Negative: No growth. Contaminated: Growth other than mycobacteria is present.
The TB Lab will initiate identification testing if the MGIT is positive. Susceptibilities will be ordered by the lab when indicated.
NA
The GA Public Health Laboratory does not charge the county or the district for this procedure.

Georgia Tuberculosis Policy and Procedure Manual 2009

144 Amplified Mycobacterium Tuberculosis Direct Test (MTD)

How does it work?

The Amplified Mycobacterium tuberculosis Direct Test (MTD) is a targetamplified nucleic acid probe test for the detection of M. tuberculosis complex rRNA in concentrated specimen sediments prepared from sputum, bronchial specimens (BAL or bronchial aspirates), or tracheal aspirates.
The MTD test is intended for use only with specimens from patients showing signs and symptoms consistent with active pulmonary tuberculosis. Patients who have received no antituberculous therapy, or less than 7 days of such therapy, or have not received such therapy in the last 12 months may be evaluated with this test.
MTD testing does not take the place of culture. A negative MTD test does not exclude the possibility of isolating M. tuberculosis from culture.

When is this test run?

Monday through Friday

How long before results are ready?

Results are available the same day the test is run.

How are the results classified? What do the results mean? Are other tests needed? When would this test be used? How would this test be ordered? How much would this test cost?

Positive, Negative, and Indeterminate.
Positive: M. tuberculosis complex rRNA is detected. Negative: M. tuberculosis complex rRNA is not detected. Indeterminate: Equivocal results. Test must be repeated.
A culture for M. tuberculosis must be performed.
This test would be ordered for first time diagnosed patient showing signs and symptoms consistent with active pulmonary tuberculosis. For rapid identification of M.tb.
By submitting a MTD Request Requisition to the GPHL
The GA Public Health Laboratory does not charge the county or the district for this test.

Georgia Tuberculosis Policy and Procedure Manual 2009

How does it work?

145 Polymerase Chain Reaction (PCR)
Polymerase Chain Reaction (PCR) is a sensitive laboratory technique that is used to detect and repeatedly copy small amounts of DNA or RNA. Once the PCR product has been formed, it can be used in further applications.

When is this test run?

Currently, this testing technique is not performed by the State TB Lab.

How long before results are ready?

NA

How are the results classified?

NA

What do the results mean?

NA

Are other tests needed?

NA

When would this test be used?

NA

How would this test be ordered?

NA

How much would this test cost?

NA

Georgia Tuberculosis Policy and Procedure Manual 2009

146 Restriction Fragment Length Polymorphism (RFLP)

How does it work?

Restriction Fragment Length Polymorphism (RFLP) is a molecular technique in which organisms may be differentiated by analysis of patterns derived from cleavage of their DNA by restriction endonuclease. If two organisms differ in the distance between sites of cleavage of a particular restriction endonuclease, the length of the fragments produced will differ. The similarity or the difference of the patterns can be used to differentiate species of mycobacteria from one another.

When is this test run? How long before results are ready? How are the results classified? What do the results mean? Are other tests needed?
When would this test be used?
How would this test be ordered? How much would this test cost?

The State Lab does not perform this test. Isolates are sent to the Michigan State Genotyping Lab for analysis.
Results are usually available within 3 weeks after the Michigan Genotyping Lab receives the isolate.
NA
The results show a mapping of the restriction fragment.
No
To rule out cross-contamination of specimens. To determine if two or more patients are infected with strains of
M. tuberculosis possessing identical genotypes. To determine reactivation vs. reinfection of a patient.
Physicians can request this test if approved by the TB Program.
There is no charge for this test.

Georgia Tuberculosis Policy and Procedure Manual 2009

147 MTB Susceptibility Testing

How does it work?

M. tuberculosis isolates are tested for sensitivity/resistance to isoniazid,

rifampin, and ethambutol using the BACTEC MGIT 960 susceptibility

method. If resistance is detected in any of the three drugs, the susceptibility

is repeated and streptomycin is added to the drug panel. All isolates

showing resistance are submitted to CDC for confirmation.



A standardized suspension of MTB is added to 4 MGIT tubes.

Tube 1 is a growth control (contains no antibiotics), Tube 2 contains

isoniazid, Tube 3 contains rifampin, and Tube 4 contains ethambutol.



The MGIT tubes are placed in the BACTEC 960 which scans the

tubes for growth once every hour.



When the growth control tube has reached 400 growth units, the

BACTEC 960 performs a final scan on tubes 2, 3, and 4 to check for

growth and then prints out a final report.



Based on growth units, it can be determined if the MTB isolate is

sensitive or resistant to each of the drugs tested.



If the MTB is sensitive to a drug, there would be no growth in that

MGIT tube. If the MTB is resistant to a drug, then the MTB would

grow in the MGIT tube and the growth units would be registered on

the BACTEC 960 report.

When is this test run?

Monday through Friday

How long before results are ready?

4 to 13 days after the actual susceptibility testing is started. Isolates must meet certain criteria before susceptibility testing can be performed. This can add up to 7 days to the turn-around-time for the susceptibility results.

How are the results classified?

Sensitive, Resistant, or Contaminated

What do the results mean? Are other tests needed? When would this test be used? How would this test be ordered? How much would this test cost?

Sensitive: The drug can be used to treat the MTB isolate. Resistant: The drug has no effect on MTB isolate. Contaminated: The susceptibility is contaminated with an
organism other than MTB and will have to be repeated.
No, unless multi-drug resistance is demonstrated. Then the isolate is sent to CDC for an expanded panel of drug testing.
To determine the susceptibility of an MTB isolate to isoniazid, rifampin, ethambutol, and in some cases to streptomycin.
When a patient is not responding to treatment and the physician feels that the susceptibility should be checked again.
Every 3 months for as long as a patient's cultures remain MTB positive.
Through the State TB Lab. Susceptibilities are automatically run on all first-time MTB positive cultures.
The GA Public Health Laboratory does not charge the county or the district for this test.

Georgia Tuberculosis Policy and Procedure Manual 2009

148
APPENDIX D POLICIES and PROCEDURES DIRECTLY OBSERVED THERAPY (DOT)
EFFECTIVE DATE: July 1, 2009
POLICY #600: Directly Observed Therapy (DOT)
INTRODUCTION/BACKGROUND: Tuberculosis (TB) treatment can seem difficult it requires taking multiple medications for at least 6 months. Most people have trouble remembering to take their medicines, especially after symptoms of the disease improve or have disappeared completely. Directly Observed Therapy (DOT) is an essential element for the prevention of further transmission of infection and disease. The ultimate purpose is to have each patient fully complete his/her first-ever TB treatment. Having every initial treatment fully completed, patients can be cured of TB and relapses are kept to minimum. This is the only effective means to avoid MDR-TB and XDR-TB, which, in developing, high burden countries, is still almost incurable. DOT entails the direct observation of the patient's self administering and swallowing the correct dose of anti-tuberculosis medications at the proper time for the complete period of therapy by a designated, trained and responsible agent of the patient. However, DOT is not just providing medication. DOT involves front line interaction with the patient. The DOT worker has the opportunity to make a genuine contribution not only to the patient's physical health but also his or her well-being. Frequently, the DOT worker will identify social service or personal needs that could interfere with completion of treatment. Helping the patient resolve these problems not only helps achieve program outcomes but it also helps the patient find the assistance needed with their problems. Directly Observed Therapy (DOT) is the standard of care in Georgia to ensure an individual who has been prescribed medication for the treatment of active tuberculosis (TB) disease or Latent TB Infection (LTBI) completes the recommended course of drug therapy by taking all the medication.
DEFINITIONS: 1. DOT directly observed therapy is the assistive and supportive act of providing the antituberculosis medication directly to the patient for self administration and observing him or her swallow the medication(s) as prescribed for the treatment of TB or LTBI. The DOT worker may not always be directly observing the very young child self administering medications, but may be assisting/observing the parent or guardian in giving the medication. DOT does not entail dispensing or administering any medication. 2. TB tuberculosis is a disease caused by the Mycobacterium tuberculosis complex that can affect any part of the body, but usually affects the lungs. The general symptoms are fever, night sweats, weight loss, and fatigue. Pulmonary TB symptoms may include productive cough and/or coughing up blood. Extrapulmonary TB may include pain or other symptoms related to the site of the disease. 3. LTBI latent TB infection is characterized by a positive reaction to a tuberculin skin test, the absence of symptoms of active TB disease, and a chest x-ray that is not suggestive of active TB disease.
Georgia Tuberculosis Policy and Procedure Manual 2009

149
GENERAL PROVISIONS: 1. DOT is required for: All suspected and/or confirmed active cases of TB disease All children <5 years of age being treated for active TB disease, LTBI or prophylactic treatment during the window period All persons being treated for LTBI who are co-infected with HIV All persons being treated for LTBI on an intermittent dosing regimen
2. If financial resources allow, DOT is strongly recommended for: Persons infected with TB that are at high risk for active disease (e.g., close contacts, immunocompromised persons, converters) All children 5 15 years of age being treated for LTBI Any person being treated for LTBI that has adherence problems
3. Each person (or legal guardian) on DOT should sign and have a copy of a DOT agreement (form #DPH06/060W).
4. DOT is considered to be given Monday through Friday except in the case of MDR-TB or XDR-TB. Only DOT doses are counted.
5. DOT provision sites: DOT can be carried out at any site mutually agreed upon by the patient and DOT provider
6. The standard DOT Screening Questions Checklist regarding TB symptoms, medication side effects and adverse reactions is to be completed at each DOT visit. The results are to be documented on the DOT sheet (form #3130-R) and in the appropriate computer system.
7. Each dose is to be documented and counted on the DOT sheet, form #3130-R at the time of ingestion. Each dose is to be transferred to the electronic database (SENDSS) in a timely manner.
8. Education should be provided to the patient at each visit. 9. The DOT worker is expected to be alert for information concerning any identified or
unidentified contacts, early warning signs of adherence problems and possible relocation of the patient and to communicate this information to the TB Nurse Case Manager promptly. 10. Any missed DOT appointments will be brought to the attention of the TB Nurse Case Manager and will be dealt with promptly according to procedures. 11. Who can provide DOT
Supervised and trained licensed or non-licensed employees of local and regional health departments.
Any supervised and trained responsible person mutually agreed upon by the patient and the health department including (but not limited to) health care personnel, employers, school staff, clergy, staff of a drug treatment center, fireman or staff of a CBO.
Employees of institutions responsible for the TB care of their residents. DOT can not be provided by a family member.
Georgia Tuberculosis Policy and Procedure Manual 2009

150 For complex regimens including IV/IM medications or twice daily dosing, home
care agencies may provide DOT or share responsibilities with the local health department. 12. Personnel without a nursing license are not allowed to pour medications from bottles, pour pills out of packets, crush pills, or mix pills with food or liquids. They are to support the patient in self preparation and self administration of his/her own medications. 13. DOT providers are required to complete the orientation and education process outlined in the current Georgia Tuberculosis Program Policy and Procedure Manual. DOT training must be documented on the DOT Provider Agreement and kept at the clinic level. All DOT workers are to sign a Provider Agreement. 14. Supervisors or TB Nurse case managers will accompany DOT providers on field visits each quarter for quality assurance purposes. 15. All medications must be stored and delivered according to the current Georgia Tuberculosis Program Policy and Procedure Manual. 16. Case conferences between the DOT worker and the TB Nurse Case Manager should be held at least weekly to share information concerning the patient's care.
REFERENCES: Francis J. Curry National Tuberculosis Center, 2003: DOT Essentials: A Training Curriculum for TB Control Programs Centers for Disease Control and Prevention. Treatment of Tuberculosis. MMWR 2003; 52 (No. RR-11)
Georgia Tuberculosis Policy and Procedure Manual 2009

151 EFFECTIVE DATE: July 1, 2009
PROCEDURE # 601: Directly Observed Therapy (DOT)
INTRODUCTION/BACKGROUND: Directly Observed Therapy (DOT) is the standard of care in Georgia to ensure an individual who has been prescribed medication for the treatment of active tuberculosis (TB) disease or Latent TB Infection (LTBI) completes the recommended course of drug therapy by taking all the medication.
GENERAL PROVISIONS:
1. Responsibilities a. All anti-tuberculosis medications shall be issued pursuant to one of the following: A prescription from a licensed practitioner authorized to prescribe An order issued in conformity with a nurse protocol or job description. A registered professional nurse is only authorized to dispense pursuant to an order issued in conformity with a nurse protocol or job description, not a prescription or an order written on a chart or phoned in by a physician. b. The physician, pharmacist or RN working under protocol is responsible for assuring each medication is dispensed according to state pharmacy law and Nurse Protocols Drug Dispensing Procedures. The nurse in charge of medications or the TB Nurse Case Manager is to verify that the medications match the medication orders, that there is adequate medication for each dose, place all of the patient's medication bottles into one bag labeled with the patient's name and date of birth, keep a log of medications distributed to the DOT provider, inform the DOT provider of any changes in medications and to coordinate with the DOT provider to assure proper delivery to the right patient on the right schedule. The TB Nurse Case Manager will assess the need for the patient's isolation and inform the DOT Provider regarding the need of using an N95 mask during DOT visits. c. The DOT provider, acting as an agent of the patient, is to obtain the patient's medications from the nurse according to local health department policies and procedures and to transport the medications to the correct patient. Each time DOT is provided, the observer should verify that the right medications are delivered to the right patient in the right amount. If this can not be confirmed, do not give the medication and notify the TB Nurse Case Manager. The DOT provider is to observe and support the patient in the self-administration of his/her medication, maintain required documentation and communicate all observations, issues or information obtained to the TB Nurse Case Manager or Physician.
2. Storage & handling of medications a. All medications are to be stored in a secured area (under lock and key when not in actual use). A complete and accurate record of all drugs on hand, received, dispensed, issued, removed or otherwise disposed of is to be kept in accordance with the record-keeping requirements of the Board of Pharmacy. All records
Georgia Tuberculosis Policy and Procedure Manual 2009

152 pertaining to drug accountability (from order & receipt of drug to actual patient administration) must be kept on file and available for inspection. b. All drugs shall be stored in designated areas within the facility that are sufficient to insure the proper sanitation, temperature, light, ventilation, moisture control, segregation and security. These conditions must also be considered when drugs are being transported. Medications kept in a car during DOT will not be in direct sunlight or visible from windows. The car doors are to be locked when medications are present. No medications can be stored in a car over 8 hours.

3. DOT Counseling and Education

a. The TB Nurse Case Manager will provide the initial explanations of DOT, TB

treatment and the following education topics:

Transmission of TB

Importance of chemotherapy as

Differences between LTBI & Active

prescribed

TB disease

Signs and symptoms of adverse

Progression of LTBI to Active TB

medication reactions

Signs & symptoms of disease

Directly Observed Therapy

Importance of HIV testing

Importance of regular medical

Respiratory Isolation & use of masks Infectious period

assessments Importance of contact investigation

b. The DOT provider will reinforce the counseling and education provided by the TB Nurse Case Manager and physician. The DOT provider will establish rapport with patient and encourage the exchange of information. He/She should learn as much as possible about the patient's beliefs and attitudes about TB, sources of social support and barriers to treatment. The DOT worker has the opportunity to make a genuine contribution not only to the patient's physical health but also his or her well-being. Frequently, the DOT worker will identify social service or personal needs that could interfere with completion of treatment. Helping the patient resolve these problems not only helps achieve program outcomes but it also helps the patient find the assistance needed with their problems. The DOT worker is expected to be alert for information concerning any identified or unidentified contacts, early warning signs of adherence problems and possible relocation of the patient and to communicate this information to the TB Nurse Case Manager promptly.
4. Documentation a. DOT visits are to be documented completely on the DOT sheet, form #3130-R daily. b. DOT may be required to be documented in each health department computer system according to local policy. c. DOT visits are to be documented in SENDSS every 30 days. d. Anything out of the ordinary (additional contact identification, social circumstances, emotional status, adverse reactions to medications, etc.) are to be documented in the patient's chart daily and are to be verbally reported to the TB Nurse Case Manager upon return to clinic after visit.
5. Missed Appointments

Georgia Tuberculosis Policy and Procedure Manual 2009

153 a. Any missed DOT appointments will be brought to the attention of the TB Nurse
Case Manager and will be dealt with promptly. b. These steps will be followed until DOT has been reinstituted. Document efforts
and results of those efforts daily. Verbally discuss with the TB Nurse Case Manager on a daily basis.
On the day of the missed appointment, the DOT worker will call all known telephone numbers for the patient. If unsuccessful, the DOT worker will go to the patient's house at the end of his/her work day to see if contact can be made.
On the second day, in addition to efforts stated above, telephone calls will be made to all known emergency contacts, employer and friends of the patient. Leave a note on the door in a plain, sealed envelope with the patient's name on it. The note should only contain a short message such as "John, Missed you yesterday. Call me at 555-555-5555. Thanks. Mary." Do a community search of known hangouts, neighbors and friends.
On the third day, in addition to the efforts stated above, a certified letter should be sent to the patient's home. A team conference should be held to decide what steps should be taken from this point, including legal action.
6. Confidentiality a. The DOT Provider must demonstrate understanding of patient confidentiality laws and observe them at all times. b. Any patient information or record will be kept in a file or folder except when in use. c. When performing a community search, do not give out information or explain why you are looking for a particular person. Just ask them "If you see Jim, please ask him to Call Mary." d. Written communication left at a patient's home due to a missed appointment should be in a plain, sealed envelope with the patient's name on the outside. Inside provide only minimal information such as "John, Missed you today. Call Mary at 555-555-5555."
7. Incentives and Enablers a. Definitions and examples Incentives are small rewards given to patients to encourage them to take their medication, keep DOT and clinic appointments and to complete treatment. Examples are restaurant or grocery gift cards, clothing or personal products, books, snacks or visiting time by the DOT worker. Enablers are things that make it possible or easier for the patients to receive treatment by overcoming barriers. Examples are gas vouchers, bus tokens, cab fare, transportation, interpretation services and timing of DOT or clinic visits. b. Incentives and Enablers should be individualized according to the patient's needs. Discussion by the team members during team conferences may be needed to identify pertinent incentives for each patient. c. Be aware of local, district, state and national resources that are available.
Georgia Tuberculosis Policy and Procedure Manual 2009

154 d. Follow local procedures to obtain and maintain accountability of each incentive or
enabler.
PROCEDURE: 1. Obtain the medication bag for each patient from the TB Nurse Case Manager or Medication Nurse. Look at each bottle inside the bag to verify that the name matches the name on the outside of the bag and that there is enough medication to cover the day's dosage. Don't borrow medications from other patient's bottles. Tell the nurse if medications are needed. Place all labeled medication bags in a carrying container. 2. Obtain information regarding isolation and the need for masks for each patient from the TB Nurse Case Manager. Make sure you have your N95 mask and a supply of surgical masks for the patients, if needed for clinic appointments. 3. Provide the clinic with an itinerary of your DOT visits for the day before leaving the clinic. Observe field safety rules. Follow local procedures for maintaining contact throughout the day. 4. Place the carrying container in your car where the medications are not visible from the windows. Place them in the cooler section of the car out of direct sunlight. During the summer keep the air conditioner on. Never put medication in the trunk. Follow local procedures to insure the proper sanitation, temperature, light, ventilation, moisture control, segregation and security. Lock the car doors whenever you exit the vehicle. 5. When you arrive at the DOT site, greet the person. Verify the identity of the patient and that you have the right medication for that patient. 6. Put on N95 mask, if needed. 7. Ask the patient how he/she is doing. Administer the DOT Screening Questions Checklist and take actions as indicated. If you identify any adverse reaction, hold the medication and immediately call the TB Nurse Case Manager. If you are the RN, assess the patient, hold the medication and call your contract physician. Document on the DOT sheet (form #3130-R). 8. If no adverse reactions are reported, proceed with the DOT visit. Make sure the patient has something to drink and a snack if needed. Give the patient the medication bag with all the medication bottles in them. 9. Observe the patient taking the pills from each bottle and verify he/she has the correct number of pills for each medication. Once the patient has removed the pills from the bottles, maintain visual contact with the pills. Avoid the patient leaving your sight, answering the phone, picking up a child or clothing. 10. Watch the patient take and swallow the medication. Make sure the patient actually swallows the medication and does not "cheek" it or hide the pills in his/her hand, clothing or furniture. Do not leave the pills with the patient to take at a later time. The first line anti-TB medications should be taken together as a single oral dose rather than divided doses. This leads to a higher and potentially more effective peak serum concentration. It is preferable for the medications to be taken on an empty stomach if tolerated. However, if the patient experiences epigastric distress or nausea when taking the medication, dosing with a snack or food is recommended. If the patient (or child) can not swallow the pills, he/she (or parent) can crush the pills and empty the capsules into one or two teaspoons of non-sugary liquid or food. Follow with the ingestion of non-medicated food or liquid. 11. It is recommended that the DOT Provider remain with the patient at least 5 minutes after the medication has been ingested, to assure that there is no regurgitation of the
Georgia Tuberculosis Policy and Procedure Manual 2009

155

medication. During this time, build rapport and trust with the patient by engaging in

interaction. Listen and try to understand the patient's knowledge, beliefs, and feelings

about TB disease and treatment. Adopt and reflect a nonjudgmental attitude about

behaviors that the patient may participate in that you may not agree with (e.g., drug use).

Identify potential barriers to adherence and involve the patient in identifying possible

solutions. Note any items or ideas that could be used as incentives or enablers for your

patient.

12. Reinforce TB education from the "12 Points of Tuberculosis (TB) Patient Education" and

answer any questions the patient has regarding the disease or treatment. Prepare the

patient for the next step in treatment.

"12 Points of Tuberculosis (TB) Patient Education"

Transmission of TB

Importance of chemotherapy as

Differences between LTBI & Active

prescribed

TB disease

Signs and symptoms of adverse

Progression of LTBI to Active TB

medication reactions

Signs & symptoms of disease

Directly Observed Therapy

Importance of HIV testing

Importance of regular medical

Respiratory Isolation & use of masks Infectious period

assessments Importance of contact investigation

13. The DOT worker is expected to be alert for information concerning anything out of the ordinary (additional contact identification, social circumstances, and emotional status) and to communicate this information to the TB Nurse Case Manager promptly. For example, in casual conversation the patient may mention participating in a hobby at a previously undisclosed location. The DOT worker could probe a little bit and find out the last time the patient participated in the hobby and which friends were there. It would be important to relay this information to the TB Nurse Case Manager for follow-up in the contact investigation.
14. After the patient has completed taking all of his/her medication, have the patient initial on the DOT sheet (form #3130-R) and place your initials beside them.
15. Have the patient put the medication bottles back into his medication bag and hand it to you. Place the completed DOT sheet in the bag with the patient's medications.
16. Confirm the next DOT appointment, the next clinic appointment and transportation to the clinic. Answer any questions or concerns of the patient.
17. Offer words of support and encouragement to the patient for his/her involvement in treatment and getting better. Offer any incentive or enabler and thank the patient for the visit.
18. Take the medication bag with you and leave the DOT site. 19. Return to your vehicle and complete any notes and documentation about the DOT visit
and observations made. 20. Place the notes and DOT sheet in the patient's medication bag and place bag into
carrying container. 21. When you get back to the clinic, return the medications to designated person in
designated area. DO NOT KEEP IN CAR. 22. Communicate with the TB Nurse Case Manager about the patients you observed today.
Coordinate any new interventions or strategies with the TB team. 23. Complete any computer documentation or other patient record documentation.

Georgia Tuberculosis Policy and Procedure Manual 2009

156 REFERENCES: Francis J. Curry National Tuberculosis Center, 2003: DOT Essentials: A Training Curriculum for TB Control Programs Centers for Disease Control and Prevention. Treatment of Tuberculosis. MMWR 2003; 52 (No. RR-11)
Georgia Tuberculosis Policy and Procedure Manual 2009

157
EFFECTIVE DATE: July 1, 2009
POLICY #602: Required training for the Public Health Directly Observed Therapy (DOT) Worker
All training must be verified and documented. Each DOT provider must sign a Provider Agreement with the terms of their responsibilities. These documents are to be kept at the local level and are to be available to the state office upon request.
SECTION A: The public health employee or contractor whose primary duty is to provide DOT
Initial Training 1. Complete the current CDC Self Study Modules on Tuberculosis available online at http://www.cdc.gov/tb/pubs/ssmodules/default.htm. These modules can be completed either online or using hard copies. The Supervisor must verify completion of each module and assess knowledge retained. Introduction to course # SS3035 Module 1: Transmission and Pathogenesis of Tuberculosis Module 2: Epidemiology of Tuberculosis Module 3: Targeted Testing and Diagnosis of Latent TB Infection and Tuberculosis Disease Module 4: Treatment of Latent TB Infection and Tuberculosis Disease Module 5: Infectiousness and Infection Control Introduction to course #SS3036 Module 6: Contact Investigation for Tuberculosis Module 7: Confidentiality in Tuberculosis Control Module 8: Tuberculosis Surveillance and Case Management in Hospitals & Institutions Module 9: Patient Adherence to Tuberculosis Treatment 2. Complete the standardized state DOT class following the current version of the DOT toolkit provided by the state office. This class can be conducted by state, district or local personnel. 3. Complete with a passing grade of 80% or better of the state standardized DOT test. 4. Demonstrate a skills check to include (but not limited to) the following: Be issued and fit-tested for correct N-95 respirator. Describe when and how to replace issued masks. Demonstrate the correct procedure for donning an N-95 Respirator. Demonstrate correct procedure for a self check of fit of an N-95 mask. Describe when an N-95 respirator must be worn during a visit for DOT. Identify an N-95 mask and a surgical mask. Correctly name and identify each TB medication after visual inspection. Correctly confirm the number of pills needed for the following dosages of each TB medication they will deliver: i. Isoniazid 300 mg; 900 mg ii. Rifampin 600 mg; 1200 mg
Georgia Tuberculosis Policy and Procedure Manual 2009

158 iii. Pyrazinamide 1000 mg; 1500 mg; 2000 mg; 3000 mg; 4000 mg iv. Ethambutol 800 mg; 1200 mg; 1600 mg; 2000 mg; 2800 mg; 4000 mg v. Pyridoxine (B6) 25 mg; 50 mg Explain the difference between a medication side effect and an adverse reaction. Describe side effects of the medications and possible actions to take. Describe adverse reactions to the medications and actions to take. Identify when to call the TB Nurse Case Manager and how to reach him/her. Be knowledgeable and able to provide basic education on the following "12 Points of Tuberculosis (TB) Patient Education":
Transmission of TB Differences between LTBI & Active TB disease Progression of LTBI to Active TB Signs & symptoms of disease Importance of HIV testing Respiratory isolation & use of masks Infectious period Importance of chemotherapy as prescribed Signs and symptoms of adverse medication reactions Directly Observed Therapy Importance of regular medical assessments Importance of contact investigation 5. Complete a minimum of 2 weeks of observation in the field of another a qualified DOT worker. 6. Complete a minimum of 2 weeks of performance in the field supervised by the DOT worker's supervisor.
On-going training and quality assurance 1. The DOT worker will attend at least one state, district or local sponsored TB update each year OR will complete self study content equivalent to 4 hours of continuing education and have it verified by the TB Nurse Case Manager or supervisor. 2. The DOT worker will be accompanied by the TB Nurse Case Manager or Supervisor on field visits at least once per quarter.
SECTION B: The DOT worker who is not a public health employee or contractor, but is a mutually agreed upon person by the patient and the health department OR a public health employee whose regular job does not involve providing DOT, but who is acting as a lay DOT worker AND will be providing assistance and support to only one client
1. Attend a one-on-one educational session with the TB Nurse Case Manager using the course outline in the DOT toolkit provided by the state office.
2. Demonstrate a skills check to include (but not limited to) the following: Be issue and fit-tested for correct N-95 respirator. Describe when and how to replace issued masks. Demonstrate the correct procedure for donning an N-95 Respirator. Demonstrate correct procedure for self check of fit of an N-95 mask. Describe when an N-95 respirator must be worn during a visit for DOT.
Georgia Tuberculosis Policy and Procedure Manual 2009

159 Identify an N-95 mask and a surgical mask. Correctly name and identify each TB medication after visual inspection. Correctly confirm the number of pills needed for the following dosages of each
TB medication they will deliver. Repeat this each time the medication changes: Explain the difference between a medication side effect and an adverse reaction. Describe side effects of the medications and possible actions to take. Describe adverse reactions to the medications and actions to take. Identify when to call the TB Nurse Case Manager and how to reach him/her. 3. Complete a minimum of 1 week of performance in the field supervised by the TB Nurse Case Manager or senior DOT worker. 4. Utilize the DOT Instruction Sheet for the DOT provider. 5. Repeat the training for each additional client assigned. If assigned more than 2 during a twelve month period, then must complete the training described in section A.
REFERENCES: Francis J. Curry National Tuberculosis Center, 2003: DOT Essentials: A Training Curriculum for TB Control Programs Centers for Disease Control and Prevention. Treatment of Tuberculosis. MMWR 2003; 52 (No. RR-11)
Georgia Tuberculosis Policy and Procedure Manual 2009

160
Directly Observed Therapy (DOT)
Agreement for Tuberculosis (TB) Treatmen

Name _________________________________________ DOB ____________ Home phone: __________________ Address __________________________________________________________ Work phone: _________________ City ______________________________________________ ZIP ___________ Cell phone: __________________ Emergency Contact Person ___________________________________ Phone: _____________________________ Health Department _____________________________________________________________________________ I, ____________________________________________ understand and agree that
(Name of Client)

1. The only way to get well is by taking my TB medicine exactly as my nurse or doctor tells me. If I do not follow these directions, my illness could come back worse than before. Then it could be harder to treat, take longer to treat and could spread the disease to others.

2. I will be taking several medications for a long time (6 months or more) in order to kill the TB germs.

3. I agree to cooperate with the supervised DOT program to help remind me to take my medicine and to make sure I complete my treatment and get well. In this program, a designated public health employee or a trained DOT worker is authorized as my agent to maintain possession my medication and to be present when I take my TB medicine.

4. I will be at: ____ Home ____ Work ____ Clinic/LHD ____ Other (specify) ______________________ between the hours of _________________ and _______________ for my DOT visit.

5. If I cannot be at the agreed place and time, I will call ________________________________ at ______________________ to change the visit.

6. If I do not call in time to change the visit, I know that I may have to go to ____________________________ between _____________ for my DOT visit.

7. I will tell my DOT worker if I have any problems. I may be asked to go to ____________________________ to meet with a doctor or nurse and/or to have tests during my treatment.

8. I know that if I miss my visits and do not take my treatment as scheduled, legal action may be taken.

I, ________________________________________________ understand and agree that (Name of Health Dept./Case Manager)
1. If I cannot be at the agreed place and time, I will call ________________________________ at ______________________ to change the visit.

2. I will keep the client's health data private.

3. I will answer questions and concerns of the client. I will help link the client to other services as needed.

4. I will promptly tell the doctor or nurse of anything out of the ordinary. I will give reports as needed.

____________________________ Client

____________________________ ___________________________

Nurse

DOT Provider

GA DPH TB Unit

603 DOT (Rev. 10/2009)

Georgia Tuberculosis Policy and Procedure Manual 2009

161
Directly Observed Therapy (DOT) Provider Agreement

I, _____________________________________ agree to provide DOT for the treatment of tuberculosis (TB) patients for 6 9 months in order to help prevent further transmission of infection and disease and prevent development of drug resistance. I understand that I will support and observe the client with the self-administration of his/her medication. I will act as the patient's agent to transport his/her medication that has been prescribed and dispensed according to Georgia law.
1. I will keep information obtained or learned confidential among the patient, myself and the health care team.
2. I will deliver the prescribed, pre-packaged medication on the days and times agreed upon in the DOT agreement signed by the patient and myself.
3. I understand DOT is the act of providing the anti-tuberculosis medication directly to the patient for self administration and observing him or her swallow the medication(s) as prescribed for the treatment of TB or LTBI. DOT does not entail dispensing, administering, pouring or altering any medication.
4. I will follow the DOT Policies and Procedures outlined in the current Georgia Tuberculosis Program Policy and Procedure Manual.
5. Prior to observing the patient take his/her medication, I will ask the questions on the DOT Screening Questions Checklist at each visit and will follow the actions to take. If I am unsure of further actions, I will contact the TB Nurse Case Manager.
6. I will watch the patient swallow all of the prescribed medication. 7. I will document the visit on the DOT Sheet. 8. I will store and transport all medications according to the current Georgia Tuberculosis Program
Policy and Procedure Manual. 9. I will immediately report to the nurse or physician immediately any missed doses or anything out
of the ordinary observed during each visit. 10. I will provide basic TB education on prepared topics 11. I will be alert for information concerning any identified or unidentified contacts, early warning
signs of adherence problems and possible relocation of the patient and communicate this information to the TB Nurse Case Manager promptly. 12. Other ___________________________________________________________________ ________________________________________________________________________

This agreement acknowledges that __________________________________ has completed & passed a DOT Training session conducted by ________________________ on ___________________. There have been _________ field visits supervised by _____________________________ . Annually, there will be ___________ supervised field visits made for quality assurance purposes.

DOT Provider________________________________________ Date ______________________ Supervisor__________________________________________ Date ______________________

GA DPH TB Unit

604 DOT (Rev. 10/2009)

Georgia Tuberculosis Policy and Procedure Manual 2009

162
DOT Screening Questions Checklist

A. TB Symptoms
1. "Are you experiencing coughing, coughing up blood, tiredness or fatigue, chest pain, fever, chills or night sweats?" If the answer is yes, ask "Has it gotten better since starting your medication?"

Action:

Symptoms should get better after being on medication for 2 3 weeks.

Notify TB Nurse Case Manager if symptoms do not get better or if they come back after having

been resolved. Code positive responses under "Checklist" on the DOT sheet as "A.1" and specify

under comments.

B. Side effects Some side effects are expected to occur in some people.

1. Do you experience nausea when taking your medication? If yes, ask "Does it get better after you eat or later in the day?"

Action:

Should resolve with time and supportive measures. Suggest the patient try

taking the medication with a snack or food. If it does not resolve or if it escalates into vomiting,

notify the TB Nurse Case Manager. Code positive responses under "Checklist" on the DOT sheet

as "B.1" and specify under comments.

2. What color is your urine?

If answers "orange/red" this is an expected side effect of Rifampin. Action:

Let

patient take medication. Code response under "Checklist" on the DOT sheet as "B.2" and specify

color under comments.

If answers "dark, maple syrup colored or coffee colored" this could be an adverse reaction.

Action:

DO NOT GIVE MEDICATION! Call the TB Nurse Case Manager

immediately for instructions. Code under "Checklist" on the DOT sheet as "C.1" and specify

under comments.

C. Adverse Reactions May indicate toxicity.
Do you have any of the following symptoms now or since the last time you saw your nurse or doctor?
1. Nausea, vomiting, abdominal pain, coffee colored urine, jaundice (yellowing of eyes or skin), fatigue, loss of appetite or flu-like symptoms
2. Skin rash, tingling in extremities 3. Changes in hearing or changes in vision 4. Bleeding problems, joint pain 5. Unsteady when walking, behavioral changes, headache

Action:

DO NOT GIVE MEDICATION! Call the TB Nurse Case Manager

immediately for instructions. Code under "Checklist" on the DOT sheet as "C.#" and specify

under comments.

Georgia Tuberculosis Policy and Procedure Manual 2009

163

Directly Observed Therapy (DOT) Sheet (form 3130-R) INSTRUCTIONS

Complete for the current drug regimen.
Drug Regimen Date Drug name Strength Dosage # of pills
09/01/09 Isoniazid 300 mg 300 mg 1 tablet

Frequency daily

09/01/09 Rifampin 300 mg 600 mg

2

daily

capsules

09/01/09 Pyrazinamide 500 mg 1500 3 tablets daily

mg

09/01/09 Ethambutol 400 mg 1200 3 tablets daily

mg

09/01/09 Pyridoxine 50 mg 50 mg 1 tablet

daily

Drug Regimen Date Drug name
09/27/09 Isoniazid
09/27/09 Rifampin

Strength 300 mg 300 mg

Dosage 900 mg 600 mg

# of pills 3 tablets
2 capsules

Frequency
Twice weekly Twice weekly

Complete the form as follows:
A. Date: Complete date of DOT visit. B. Checklist: Place a 9 if the Screening Questions were asked and an X if they were not asked. If any
positive answer was given, indicate the section letter (A, B or C) and applicable number (if any). If the patient was not available at the scheduled time, but showed up later, place / 9 or X. C. Actions taken: Note action taken based on DOT Screening Questions Checklist or the Georgia Tuberculosis Program Policies and Procedure Manual. D. DOT dose: 9 after DOT completed. E. SA: 9 If patient states he/she self administers (SA) without DOT (weekend doses). These doses will
not be counted.
F. Missed dose: If the patient missed a dose, explain why. If later in the day the dose was given,
place / and note results.
G. DOT initials: DOT provider initials after the DOT visit is completed.
H. Patient initials: Patient initials after the DOT visit is completed.
I. Comments: Write any supporting comments

A
Date
09/01/08 09/02/08 09/03/08 09/04/08 ...

B
Check list
9 B1
9 9 X / 9

C
Actions taken

D
DOT dose

Snack with medication
Made 3 calls to patient

9
9 9 X/ 9

E F
SA Missed dose why? / results @ end of day
not home /pt @ clinic 4:30pm

G
DOT's initials

H
Patient's initials

GM

JD

GM GM GM / GM

JD JD
/ JD

I
Comments
Collected & mailed sputum specimen #2
Located- Pt. come by clinic before 5 pm

/29/

09/30/08 9 C1

Called nurse

X

instructed to with hold

meds

Adverse reaction - GM

JD

Nurse to assess

patient

Patient vomiting all night with stomach cramps

When the month is completed, both the DOT provider and the patient initial and sign the form.

This form is to be reviewed by the TB Nurse Case Manager weekly. Any occurrence out of

the ordinary during a DOT visit should be reported to the TB Nurse Case Manager that day.

GA DPH TB Unit

606 DOT (Rev. 04/2009)

Georgia Tuberculosis Policy and Procedure Manual 2009

164

Directly Observed Therapy (DOT) Sheet

Patient name & phone numbers __________________________________________________________________ DOT site address ___________________________ DOT time scheduled ________ DOT Provider _____________

Drug Regimen Date Drug name

Strength

Date
/01/ /02/ /03/ /04/ /05/ /06/ /07/ /08/ /09/ /10/ /11/ /12/ /13/ /14/ /15/ /16/ /17/ /18/ /19/ /20/ /21/ /22/ /23/ /24/ /25/ /26/ /27/ /28/ /29/ /30/ /31/

Isoniazid

300 mg

Rifampin

300 mg

Pyrazinamide 500 mg

Ethambutol 400 mg

Pyridoxine

50 mg

Checklist Actions

taken

Dosage

# of Frequency pills

Drug Regimen Date Drug name

Strength Dosage # of Frequency pills

DOT SA Missed dose why?

Provider Patient Comment

DOT Provider initials ___ Signature __________________ Patient's initials ___ Signature ____________

GA DPH TB Unit

606 DOT (Rev. 04/2009)

Georgia Tuberculosis Policy and Procedure Manual 2009

165
Directly Observed Therapy (DOT) Skills Check Off List

DOT Training Record for ________________________________________________

Initial Training
Self Study Module: Introduction to course #SS3035 Self Study Module 1: Transmission & Pathogenesis of TB Self Study Module 2: Epidemiology of TB Self Study Module 3: Targeted testing & Diagnosis of LTBI & Disease Self Study Module 4: Treatment of LTBI and Disease Self Study Module 5: Infectiousness & Infection Control Self Study Module 6: Contact Investigation for TB Self Study Module 7: Confidentiality in TB Control Self Study Module 8: TB Surveillance & Case Management in Hospitals & Institutions

Date completed

Self Study Module 9: Patient Adherence to TB Treatment Standardized State DOT Power Point & videos Passed DOT test at 80% or better Demonstrated competency on skills check off list Completed ________ weeks of observation in the field with another qualified DOT worker _________________________

Completed ________ weeks of performance under the observation of ____________________________________

Signed DOT Provider Agreement

Supervisor

On-going training
TB Update & Skin Test Certification class Skills validation completed & sent to state office Contact Investigation class Other: Other: Other: Other: Other: QA/QI Field visits conducted by Date

Date

Date completed

Supervisor

Date

Date

Georgia Tuberculosis Policy and Procedure Manual 2009

GA DPH TB Unit

166
611 DOT (Rev. 10/2009)

Georgia Tuberculosis Policy and Procedure Manual 2009

167
Directly Observed Therapy (DOT) QA/AI Field Visit

Date _________________________ Name of DOT Worker ____________________________________________________________

Excellent
Consistent and proper use of verification processes Prioritized field visits geographically Organization of medications, records & supplies Itinerary completed and left at clinic Storage & transport of medications Observes field safety & personal safety Maintains patient's confidentiality Verifies patient's identity matches medication bag Establishes rapport with patient Communicates at patient's level of understanding Gives factual information Uses "DOT Screening Questions Checklist" appropriately Ensures patient has drink before handing medication Observes & verifies the patient taking the correct number of pills from each bottle Watches the patient swallow all pills & is alert for tricks Has patient initial DOT sheet & completes documentation Remains with patient at least 5 minutes after ingestion Reflects a non-judgmental attitude Asks open-ended questions Recognizes problems communicated by patient Effectively elicits information from patient Recognizes discrepancies in previous responses Picks up on clues from patient and probes appropriately Re-enforces patient education Acknowledges barriers and works with patient to resolve Offers support and encouragement to patient Confirms & prepares patient for next step/visit Leaves patient with positive motivation Stores & transports medications appropriately Observes field safety & personal safety Maintains patient's confidentiality

Acceptable Needs Improvement

Georgia Tuberculosis Policy and Procedure Manual 2009

168 Returns medications to designated place & person Communicates with TB Nurse Manager about observations made today Completes necessary documentation SUMMARY & FEEDBACK:
FOLLOW-UP PLAN:
Signature of DOT Worker ________________________________________ Date_____________ Signature of Reviewer __________________________________________ Date_____________ Georgia Tuberculosis Policy and Procedure Manual 2009

169
DOT Instruction Sheet

Date started _______________________________

Name

Address

Patient

DOT Worker

Main phone

Cell phone

TB Nurse Case Manager

Medications:
Medication name & dosage
Isoniazid _______________ mg
Rifampin _______________ mg

Picture of medication Number of Pills to take Number of Days / week

Pyrazinamide ____________ mg
Ethambutol _____________ mg Pyridoxine (B6) __________ mg

DOT Days (circle): Monday Tuesday Wednesday Thursday Friday

DOT Time: ______________________ Mask Needed?

No

Yes

DOT Location:

_______________________________________________________________________

DOT Sheet #3130-R

DOT Screening Questions Check list Medications



Check in day & time: ________________________________________ Phone:

___________________

Next Clinic appointment:

_______________________________________________________________

Additional Instructions:

GA DPH TB Unit

614 DOT (Rev. 10/2009)

Georgia Tuberculosis Policy and Procedure Manual 2009

170 APPENDIX E POLICIES and PROCEDURES TUBERCULIN SKIN TEST (TST) 1. The Tuberculin Skin Test (TST) 2. Administration of Mantoux Tuberculin Skin Test (TST) 3. Reading Mantoux Tuberculin Skin Test (TST) 4. Classification of the Mantoux Tuberculin Skin Test (TST)
Georgia Tuberculosis Policy and Procedure Manual 2009

171
The Mantoux Tuberculin Skin Test (TST)
It is strongly recommended that individuals who administer, read and interpret the Mantoux TST are certified in the process by attending the TB Update and Tuberculin Skin Test Certification Workshop. For availability of the workshops, contact the district TB coordinator, the Georgia state TB Unit or log on to the website http://health.state.ga.us/programs/tb/training.asap.
Purpose: To determine whether a person has become infected with Mycobacterium tuberculosis. This test cannot determine whether the person has Active TB Disease or Latent TB Infection.
In general, it may take up to 10 weeks after infection for a person to develop a delayed-type immune response to tuberculin which is measurable with the Mantoux TST. During the test, tuberculin is injected intradermally into the skin. The immune system of most persons with tuberculosis infection will recognize the tuberculin, causing a reaction in the skin. Repeated TSTs do not produce hypersensitivity.
The size of the measured induration (a hard, dense, raised formation) and the patient's individual risk factors should determine whether TB infection is diagnosed. Based upon the sensitivity and specificity of the purified protein derivative (PPD) TST and the prevalence of TB in different groups, three cut-points have been recommended for defining a positive tuberculin reaction:
Greater than or equal to 5 mm induration Greater than or equal to 10 mm induration Greater than or equal to 15 mm induration
Candidates for the Mantoux Tuberculin Skin Test
The Mantoux TST can be administered to all persons, including pregnant women, persons who have previously been vaccinated with bacilli Calmette-Guerin (BCG), and human immunodeficiency virus (HIV)-infected persons. However, persons with a documented prior positive TST do not need another TST. The Mantoux TST should not be administered until at least four weeks after vaccination with live-virus vaccines.
Persons who have tested positive in the past and can provide documentation of their status should not have another TST. Instead, they should have a TB symptom assessment questionnaire administered to identify any symptoms of TB disease. Persons who are symptomatic should have a chest radiograph performed.
Multiple puncture tests such as the Tine test should not be used. The multiple puncture tests are not reliable because the amount of tuberculin injected intradermally cannot be precisely controlled and there is no standard for interpretation.
Certain factors identify persons at high risk for TB infection and/or for progression to TB disease. Persons in the high-risk groups listed in the following table (Persons at High Risk for
Georgia Tuberculosis Policy and Procedure Manual 2009

172 Tuberculosis Infection and Progression to Tuberculosis Disease) are candidates for tuberculin skin testing.
Persons with risk factors from both columns may be at much higher risk than those with risk factors in only one column. For example, an individual born in a high-TB-prevalence country who is also infected with HIV infection is at a much higher risk of having or developing active TB than a US-born individual with HIV infection.
PERSONS AT HIGH RISK FOR TUBERCULOSIS INFECTION AND PROGRESSION TO TUBERCULOSIS DISEASE

For Tuberculosis (TB) Infection

For Progression to TB Disease3

High-priority contacts such as housemates or coworkers, or contacts of persons who have smear-positive pulmonary or laryngeal tuberculosis (TB) Infants, children, and adolescents exposed to adults in high-risk categories Recent immigrants (primarily <5 years) from countries with high incidence of TB (Asian, African, Latin American, and Eastern European countries have TB rates 530 times higher than U.S. rates, and an increasing percentage of TB cases in the United States are occurring among immigrants from those countries) Residents and employees of high-risk congregate settings (e.g., correctional institutions, nursing homes and other long-term care facilities providing care to high-risk residents and clients, and homeless shelters) Some healthcare workers who serve high-risk clients, especially emergency departments, staff involved in high-risk procedures, and laboratories manipulating TB cultures Some high-risk racial or ethnic minority populations, defined locally as having an increased prevalence of TB (in Washington State this group includes American Indians and Alaskan Natives) Some medically underserved, low-income populations as defined locally (e.g., homeless, transient populations) Persons who inject illicit drugs; any other locally identified high-risk substance abuse users

Persons with HIV infection Infants and children aged <5 years Persons infected with Mycobacterium tuberculosis within the previous 2 years Persons with a history of untreated or inadequately treated TB disease Persons with radiographic findings consistent with previous TB disease Persons who use alcohol or illegal drugs (such as injection drugs or crack cocaine) Persons with any of the following clinical conditions or other immunocompromising conditions:
Silicosis Diabetes mellitus End-state renal disease (ESRD)/chronic renal failure, hemodialysis Some hematologic disorders (e.g., leukemia's and lymphomas) Other malignancies (e.g., carcinoma of head, neck, or lung) Body weight 10% below ideal body weight Prolonged corticosteroid use Use of other immunosuppressive treatments (e.g., prednisone or tumor necrosis factor-alpha [TNF-] antagonists) Organ transplantation Gastrectomy Chronic malabsorption syndromes Jejunoileal bypass

Source: Adapted from: CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR 2005; 54(No. RR-17):45; CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000; 49(No. RR-6):79. Also, Tuberculosis Infection Control: A Practical Manual for Preventing TB http://www.nationaltbcenter.edu/products/index.cfm

Georgia Tuberculosis Policy and Procedure Manual 2009

173

Administration of Mantoux Tuberculin Skin Test

Supplies:

Tuberculin syringe 27-gauge needle " or 3/8" needle length 5 Tuberculin unit strength PPD solution Alcohol pads Cotton ball Gloves (Note: gloves may or may not be worn according to facility)

Procedure:

1. Draw up 0.1 ml of PPD solution into tuberculin syringe 2. Expel excess air bubbles 3. Clean area of forearm (dorsal or volar surface) with alcohol pad. Let dry. 4. With bevel of needle facing upwards, inject the solution intradermally (just
under the 1st layer of skin). A tense wheal (bubble) approximately 6 - 10 mm should be visible at the injection site. 5. Withdraw the needle and dispose into SHARPS container. 6. Patient (or nurse if wearing gloves) may "dab" any spot of blood appearing at the site with a cotton ball. Do not place a Band-Aid on the site. 7. Instruct patient to return in 48 72 hours for reading.

Reading Mantoux Tuberculin Skin Test (TST)
Georgia Tuberculosis Policy and Procedure Manual 2009

174

Reading Mantoux Tuberculin Skin Test (TST)

Purpose: To determine a reaction to the tuberculin solution and measure the size of the induration (raised hardened area)

Procedure:

1. Test is read by a trained healthcare worker 48 72 hours after the TST Placement. If a patient fails to show up for the scheduled reading, a positive reaction may still be measurable up to 1 week after testing. However, if a patient fails to return within 72 hours and shows no induration, the TST should be repeated.
2. The area of induration (palpable raised hardened area) around the site of injection is the reaction to tuberculin that is to be measured. Erythema (redness) and soft tissue swelling are not to be measured.
3. Palpate the injection site for induration. The borders of the induration can be marked with a ballpoint pen or with the fingernail.
4. Using either a flexible ruler or caliper ruler with millimeter markings, measure across the forearm (perpendicular to the long axis or transversely). All reactions should be recorded in millimeters (e.g. 12 mm). If no induration is found, "0 mm" should be recorded.

Palpation of the induration

Measurement of the induration

Georgia Tuberculosis Policy and Procedure Manual 2009

175
Classification of the Mantoux Tuberculin Skin Test (TST)
Purpose: The determination of a positive reaction to the Mantoux tuberculin skin test depends on the size of the induration and the person's risk factors for TB
Procedure:
4. A tuberculin reaction of >5 mm of induration is classified as positive in the following groups: HIV positive persons Recent contacts of TB case Persons with fibrotic changes on chest radiograph consistent with old healed TB Patients with organ transplants and other immunosuppressed patients
5. A tuberculin reaction of >10 mm of induration is classified as positive in persons who do not meet the preceding criteria but who have other risk factors for TB. These include: Recent arrivals (<5 years) from high-prevalence countries Injection drug users Residents and employees of high-risk congregate settings: prisons and jails, nursing homes and other long-term facilities, hospitals and other health-care facilities, residential facilities for AIDS patients, and homeless shelters Mycobacteriology lab personnel Persons with clinical conditions that place them at high risk: Substance abuse, diabetes mellitus, silicosis, cancer of the head and neck, hematologic and reticulendothelial diseases, end-stage renal disease, intestinal bypass or gastrectomy, low body weight (>10% below ideal the ideal), and chronic malabsorption syndromes Children <4 years of age, or children and adolescents exposed to adults in high-risk categories
6. A tuberculin reaction of >15 mm of induration is classified as positive in persons with no known risk factors for TB.
7. Record the size of the induration in millimeters (mm) Don't write "negative" or "neg" but record as 00 mm or 7 mm, etc. Do write positive results as a number, not positive," such as 10 mm, 12 mm
8. Give client official documentation of results
Georgia Tuberculosis Policy and Procedure Manual 2009

176
APPENDIX F
Procedure for Sputum Specimen Collection and Serum Levels for Isoniazid and Rifampin
Purpose: Persons suspected of having pulmonary or laryngeal TB should have sputum specimens examined by smear and culture. Detection of acid-fast bacilli (AFB) in stained smears examined microscopically may provide the first bacteriologic clue of TB. Positive cultures for M. Tuberculosis confirm the diagnosis of TB. For those patients whose sputum smears and cultures are positive before treatment, the best way to measure the effectiveness of therapy is to obtain specimens at least monthly.
Infection Control: Infectiousness is directly related to the number of tubercle bacilli expelled into the air. In general, persons who have pulmonary or laryngeal TB should be considered infectious if they are coughing, undergoing cough induction, or have positive AFB smears. While collecting sputum the healthcare worker should:
1.Wear the N-95 NIOSH approved particulate respirator. 2. While collecting the specimen, take the client outside
unless the facility has a designated negative pressure room or sputum collection booth.
Supplies: TB sputum collection outfits (All outfits include needed tubes, lab slips, cans for mailing and instruction sheet) obtained from the Georgia Public Health Laboratory at 1749 Clairmont Road, Decatur, GA. 30033-4050. Telephone: 404-327-7900.
Procedure: 1. Explain to client that sputum comes from the lungs after a deep cough (not spit, saliva, or nasopharyngeal discharge). 2. Best time of day to collect sputum is when you first wake. 3. Rinse (do not swallow) the mouth with water before sputum is collected to minimize residual food particles, mouthwash, or oral drugs that might contaminate the specimen. 4. Best if you do not eat, drink or smoke before coughing up sputum from the lungs. 5. Fill out lab slip completely and correctly. 6. Fill in client's name on the plastic tube. 7. Give client the container with a plastic tube. 8. Have client cough sputum into the tube. 9. Replace the cap on the plastic tube and fasten securely. 10. Write date of collection in the proper box on the lab slip. 11. Place the plastic tube in the metal can and tighten the cap. 12. Wrap the lab slip around the metal can and put them in the cardboard can together and tighten the cap securely. 13. Make sure the information on the tube and the lab slip match and both have the client's correct name.
Georgia Tuberculosis Policy and Procedure Manual 2009

177 14. Drop the container in the nearest mailbox after proper postage has been applied. 15. It is important that specimens be refrigerated if mailing or delivery is delayed.

Sputum Collection Instructions

Sputum is mucus or phlegm coughed up from your lungs (not spit, saliva, or nasopharyngeal discharge). Sputum samples are used to diagnose active tuberculosis (TB) and to monitor the effectiveness of TB treatment.

Step 1

Drink plenty of water the night before collection. Best time of day to collect sputum is when you first wake.
Do not eat, drink or smoke before coughing up sputum from the lungs.
Rinse (do not swallow) the mouth with water before sputum is collected to minimize residual food particles, mouthwash, or oral drugs that might contaminate the specimen.

Step 2

Go away from other people either outside or beside an open window before collecting the specimen. This helps protect other people from TB germs when you cough.
Take the plastic tube with you. The collection tube is very clean. Do not open it until you are ready to use it. Carefully open the plastic tube.

Step 3

Take several deep breaths. Cough hard from deep inside the chest three times to
bring sputum up from your lungs. Spit the sputum into the tube carefully. Try not to touch
the rim of the container. Repeat until you have 1 2 tablespoons of sputum in the
tube. Replace the cap tightly on the plastic tube. Wash and dry the outside of the tube. Write date of collection in the proper box on the lab slip.

Georgia Tuberculosis Policy and Procedure Manual 2009

Step 4 Step 5

178
Place the primary specimen container (usually a conical centrifuge tube) in the clear plastic baggie that has the biohazard symbol imprint.
Place the white absorbent sheet in the plastic baggie. Expel or "push" excess air from the plastic baggie and
then seal it. Refer to the printed instructions on the baggie for detailed guidance on sealing the baggie properly. Place the plastic baggie inside the white Tyvek envelope. Expel or "push" excess air from the Tyvek envelope and then seal the Tyvek envelope securely. Place the Tyvek envelope inside the fiberboard canister. Place the specimen submission form inside the fiberboard canister. Screw the canister lid onto the canister. Secure the lid closed with sealing/mailing tape.
Immediately ship the specimen via US Post Office. Call the county TB clinic and report that you have
collected and mailed the specimen.
Contact Name ________________________________
Phone Number ________________________________

GA DPH TB Unit
Georgia Tuberculosis Policy and Procedure Manual 2009

Rev. 01/2009

179
Procedure for Serum Levels for Isoniazid (INH) & Rifampin (RIF)
The procedure is listed below for obtaining INH & RIF serum drug levels.
1. Call LabCorp to get detailed instructions and request that they send an INH & RIF drug level test kit. Also ask the lab if both blood levels can be calculated from the same tube or if separate tubes are required for each drug level test. If INH & RIF levels can be calculated from the same tube, you will only need three separate red top tubes. If not, you will need six separate red top tubes.
2. The test consists of a series of three blood draws on the same day (e.g., baseline, peak and trough).
3. At least 2 ml of serum is needed for each lab test. This will require that 10 ml of blood be drawn and placed in each of the three (or six) red top tubes.
4. Make sure that the client is receiving the medication as ordered. This is especially important to obtain true drug levels.
5. On the day of the test, draw a baseline level in a red top tube(s). Follow the lab's instructions as to how the serum from the blood should be handled and frozen. Label the tube(s) of blood Baseline.
6. Administer the prescribed medications (INH & RIF) according to schedule.
7. Two hours after the INH & RIF are administered, draw blood for a peak level and place sample in a second red top tube(s). This, too, will need to be 10 ml each. Follow the lab's instructions as to how the serum from the blood should be handled and frozen. Label the tube(s) of blood Peak.
8. Six hours after the INH & RIF have been administered (which will be four hours after the peak level is drawn), draw blood for a trough level and place the sample in a third red top tube(s). Follow the lab's instructions as to how the serum from the blood should be handled, wrapped and frozen. Label the tube(s) of blood Trough.
9. The packaged tubes of serum should remain frozen during transport even if the use of dry ice is required.
10. The LabCorp code for requesting an INH drug level is 202237. The LabCorp code for requesting a Rifampin drug levels is 833996.
LabCorp should be able to answer any questions about preparation and transport of the specimens. If you have additional questions, please call 404-657-2634.
Georgia Tuberculosis Policy and Procedure Manual 2009

180
APPENDIX G
Goal Matrix Tool: Uniform Clinical Performance Measures For TB Nurse Case Managers 2006*
Case management is the collaborative approach to providing and coordinating health care and support services for a patient. The case manager in a local public health tuberculosis (TB) program is assigned responsibility for ensuring that each patient is educated about TB and its treatment, receives a full course of treatment, and that priority contacts are examined. Public health nurses traditionally play a prominent role in case management.3 The specific interventions and outcomes of care were set forth in A TB Patient-Centered Care (PCC) Model for Completion of Therapy. Performance measures are needed to teach, monitor, and evaluate these intervention goals.
The goal matrix tool provides uniform clinical performance measures for activities TB nurse case manager's (NCMs) typically perform at the patient-provider level. It organizes program expectations to clarify how the case manager should carry out steps in meeting the patient's care, support, and treatment needs. The tool consists of performance measures, rated as unacceptable, inadequate, standard, good, and outstanding, for each intervention goal in the TB PCC model.
The tool was developed by an expert panel consisting of 10 TB nurse consultants and performance measurement experts by describing established practice activities. TB nurses tested the tool by reviewing local health jurisdiction records at 12 sites in 8 states (10 TB patients per state) and marking recorded activities on the goal matrix tool.
Measures in the tool were found to be clear, valid, and useful. They correlate with TB NCM's experience. Since these measures are a valid description of established activities, systematic recording will help determine how these actions affect treatment outcomes and quality of practice. However, many programs were found to have fragmented and incomplete data sources. Some programs used multiple care providers without an assigned case manager.
Use of this tool can facilitate training and skill acquisition, technical assistance, quality improvement, and performance measurement. The NCMs, clinical supervisors, program managers, and state/regional nurse consultants use the tool in different ways. The NCMs selfevaluate by comparing their performance with the expected standard performance while supervisors witness and mentor that performance. The program managers and state/regional nurse consultants assess how the local program describes, implements, records, and evaluate these uniform clinical performance measures.
The standard measures should be described in program procedures as an expected activity. Then selected indicators of standard measures recorded in a standard format. However, standard measures may be performed but not recorded on forms. Therefore, a variety of recorded data sources and personal communication with the NCM and program manager may be required to score program performance.
Georgia Tuberculosis Policy and Procedure Manual 2009

181 Expected performance is recorded in policies, position descriptions, skill training documents, care/service plans, clinical pathways, and procedures. Actual performance is recorded in program records including the clinical medical record, outreach, contact investigation, and registry records. Specifically, actual performance may be recorded on various forms including admission, assessment, bacteriology laboratory, Health Insurance Portability & Accountability Act (HIPAA), and request for housing assistance forms. Additional forms include the Report of Verified Case of TB (RVCT), Report of Contacts, Patient Problem List, contacts, treatment plans, care plans, patient education plans, nurses' notes, progress/clinic notes, and social work notes.
The goal matrix tool can be used to measure clinical performance for a single case. The first step is to select goal interventions appropriate to the medical diagnosis and individual patient's characteristics and check applicable goals on the matrix. Then, score the selected goals. Determine if ALL standard measures have been met. If no, determine how many standard measures have been met. If yes, determine if good or outstanding measures have also been met. Record one score (0-4) for each intervention goal in the left column of the Goal Matrix and in the Performance Score column of the Self-Evaluation Scoring Sheet (see Appendix 1).
To obtain a single case score, divide the summary Performance Score by number of selected goals (see Scoring Sheet in Appendix 1). This single case score can be used to gauge how the NCM carries out standard performance measures.

Standardized Goal Interventions5

1. Risk identification 2. Health screening 3. Culture brokerage 4. Sustenance support 5. Emotional support 6. Teaching of disease
process, treatment regimen 7. Patient's rights protection 8. Mutual goal setting

9. Patient contracting 10. Medication management 11. Discharge planning 12. Health policy monitoring 13. Infection control 14. Protection from disease 15. Surveillance: data and
decision making

Table 1: Selecting Goals: Medical Diagnosis, Individual Characteristics, and Core Goals

Diagnosis/Goals 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Disease/suspect x x x

xxxxx x x

x

TLTBI

x x x

x x x x x

x

Infectious TB

x x x

xxxxx x x x x x

Homelessness

x

Emotional need

x

Potential

x

move/provider

change

Georgia Tuberculosis Policy and Procedure Manual 2009

182
The goal matrix tool can also be used to assess program performance. To obtain a program score for each standard measure, create a cross tabulation table to identify performance measures the program expects and how the NCM performs and records these measures (Appendix 2). List standard goal intervention measures on the left horizontal row. Label "In Program Policy/Procedure," "Recorded," and "Performed, Not Recorded" above vertical columns to the right. The standard measures should be described in program policy or procedures as an expected function. Selected indicators of standard measures should be recorded in a standard format. Standard measures that are performed, but not recorded should be considered for procedure development. This table can be used to identify opportunities for describing the program's policies, procedures, and indicators for evaluation.
Tool Limitations: The tool describes performance measures for providing TB care and support to individual patients receiving medical care. It may not be useful when the health department role is limited to indirect epidemiologic surveillance and monitoring treatment decisions and outcomes. It may not be useful when patients are confined in long-term congregate settings (prison, jail, nursing home, or hospital), when case management activities are entirely provided by a private provider, or when the health department is notified after the person's death. The tool can be useful when TB patients have caregivers or legal guardians. While the tool is designed to increase standardization, the scoring process requires judgment in interpreting the findings.
Suggested citation: Goal Matrix Tool: Uniform Clinical Performance Measures for TB Nurse Case Managers 2006. NTNC/NTCA Informatics Committee Co-Chairs: Judy Gibson and Kim Field Acknowledgements: Kathy Kolaski, Karen Buford, Connie Martin, Carolyn Martin, Ann Poole, Jo-Ann Arnold, Lorena Jeske, Janice Boutotte, Lynelle Phillips, Gayle Schack, Jane Moore, D.J. McCabe, Lillian Priog, Karen Galanowsky, Maureen Wilce
References: 1. Gibson, J. D., Kolaski, K., Poole, A., Buford, K., Arnold, J., Field, K., et al, (2006). Developing tools for measuring uniform clinical performance: nursing interventions to improve TB treatment completion. In Public Health Poster Session: American Thoracic Society.
2. Gibson, J., Moore, J., Thackery, V., Nguyen, N., & Wilce, M. (2005). Standardized nursing case management interventions in a TB targeted testing project: evaluation. In (pp. 23). Vancouver, B.C.: The International Union Against Tuberculosis and Lung Disease North America Region.
3. Daugherty-Gibson, J., Field, K., Boutotte, J., & Wilce, M. (2002). Developing a case management model for ensuring completion of TB therapy. The International Journal of Tuberculosis and Lung Disease, 10, S105.
4. Daugherty-Gibson, J., & Wilce, M. (2001). TB case management for completion of therapy, 1997. The International Journal of Tuberculosis and Lung Disease, 11, S44.
5. Johnson, M., Bulechek, G., Butcher, H., Dochterman, J. M., Maas, M., Moorhead, S. et al. (2006). NANDA, NOC, and NIC Linkages. (2nd ed.) St. Louis: Mosby Elsevier.
6. Kaufman, D., Roberts, W.D., Merrill, J., Lai, T.Y., & Bakken, S. (2006). Applying an evaluation framework for health information system design, development, and implementation. Nursing Research, 55(2 Suppl), S37-42.
Georgia Tuberculosis Policy and Procedure Manual 2009

183
*Endorsed by the National TB Nurse Coalition (NTNC)
Goal Matrix: Uniform Clinical Performance Measures for TB Nurse Case Managers

Instructions for scoring clinical performance for a single case: Scale all selected goals as follows: when ALL Standard performance measures are met, determine if Good and Outstanding measures are also met. If ALL Standard performance measures are met, without additional Good or Outstanding level measures, scale as Standard performance. When ALL Standard performance measures are met plus at least one Good level measure, but not ALL Good and Outstanding level measures, scale as 3. When ALL Standard performance measures plus ALL Good and Outstanding level measures are met, scale as 4. When NOT ALL Standard performance measures are met, determine how many measures have been met for the scale. When at least one Standard performance measure is met, scale as one. When NO Standard performance measures are met, scale as 0. When assessment finding for a goal is "no need identified," circle "NA."

CORE - Goal 1: Risk Identification

Prioritization of Risk Reduction Strategies

Check applicable performance level or mark NA if not applicable

9/NA

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. At baseline, identifies potential TB-related risk factors (e.g., high risk of HIV

exposure, HIV-related conditions, exposure to TB)

2. Assesses persons with TB-related risk for symptoms compatible with active

TB disease (unexplained productive cough > 2 weeks); immediately arranges

for evaluation of symptomatic individuals

3. Every 4 weeks during treatment, assesses for change in health care risks

(e.g., ability to engage in treatment, trust drug efficacy, trust provider, follow

treatment schedule)

4. Implements risk reduction steps

Good Performance (3)

Does standard plus > 1 of following:

1. Plans risk reduction activities with patient

2. Assesses for new risk factors; appropriately modifies care plan once during

treatment period

Outstanding Performance (4) Does ALL Standard, Good, and Outstanding measures:

Assesses for new risk factors; appropriately modifies care plan more than once

during treatment period

9/NA

CORE - Goal 2: Health Screening

Detecting TB-Related Health Risks by History, Exam, Tests

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Schedules health screening appointments and follows up delinquencies to

control missed appointments

2. Assesses for pulmonary symptoms. When found, obtains order for > 2-3

sputum specimens for microscopic, culture, histopathological exams

3. Counsels, tests, and refers for HIV infection

4. Assesses for the likelihood of drug resistance

Georgia Tuberculosis Policy and Procedure Manual 2009

Good Performance (3) Outstanding Performance (4)

184
5. Uses quality assurance procedures to control errors: e.g., TST and sputum collection procedures 6. Promptly reviews incoming test reports for abnormal findings and for standard turn-around times 7. Obtains medical review for TB-related history and symptoms identified and for abnormal screening test findings the same day as received 8. Identifies or rules out TB 9. Reports to public health department Does standard plus > 1 of following: 1. Performs multiple steps in TB screening tests and medical evaluation in < 2 weeks Does ALL Standard, Good, and Outstanding measures: 1. Verifies test reports are received by standard turn-around time; when reports missing, calls vendors 2. Reviews all test reports for consistency with state and local time/quality standards; when inconsistency found, alerts local health director or program manager

9/NA

CORE - Goal 3: Culture Brokerage

Planning Strategies to Bridge Patient's Culture and Health Care System

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Assess need for interpretive service; as needed, seeks professional

(neutral) medical interpreter service (does NOT use family members)

2. Assesses patient's TB knowledge, attitudes, and beliefs concerning drug

efficacy and severity of TB disease

3. Facilitates intercultural communication (e.g., bilingual written

materials/media, accurate non-verbal communication)

Good Performance (3)

Does standard plus > 1 of following:

1. Assesses for potential conflicts in approach to TB treatment and naming of

exposed persons; identifies nature of differences

2. Assesses suitability of enlisting family and significant other(s) in supporting

cultural needs

Outstanding Performance (4) Does ALL Standard, Good, and Outstanding measures:

Assesses for means to bridge the gap between the patient and provider`s

approach to TB treatment and control

9/NA

Goal 4: Sustenance Support

Helping to Locate Food, Clothing, Shelter

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Assesses for homeless or doubled-up housing status

2. Assesses for adequacy of food supplies in home

3. Gives patient housing and/or subsidy program access information (e.g.,

agency name, phone number, address)

Good Performance (3)

Does standard plus > 1 of following:

Georgia Tuberculosis Policy and Procedure Manual 2009

Outstanding Performance (4)

185
1. Assesses for transportation needs; if needed, arranges transportation to emergency housing shelter program and/or agency providing other assistance 2. Verifies that patient has contacted referral source for services within 2 weeks of referral Does ALL Standard, Good, and Outstanding measures: 1. Assesses for literacy/other limitations; if needed, completes and submits required housing and/or subsidy forms for the patient 2. Verifies patient has been evaluated for services within 1 week of referral 3. Monitors for appropriate change in patient's needs following social support

9/NA

Goal 5: Emotional Support

Providing Reassurance, Acceptance, and Encouragement

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Assesses for stress behaviors that may interfere with TB treatment, i.e.,

attack and/or withdrawal behavior

2. Assesses for unconscious behaviors that may interfere with treatment (e.g.,

denial).

3. Assesses for refusing TB treatment (word or actions)

Good Performance (3)

Does standard plus > 1 of following:

Assesses for the potential impact of psychiatric and substance abuse issues

on TB treatment

Outstanding Performance (4) Does ALL Standard, Good, and Outstanding measures:

1. Explores how patient endures stressful events; addresses in plan

2. Assesses for emotional barriers to treatment; if needed, refers for substance

abuse or mental health counseling

3. Assesses for engagement in treatment; when unable to engage owing to

substance abuse or psychiatric problems, refers to treatment program

9/NA

CORE - Goal 6: Teaching

Information on TB Disease Process and Treatment

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Develops educational plan of clear, accurate, standardized information with

time line for completion of steps

2. Uses language understood by patient (conversation, sign, written)

3. Covers all topics in the teaching plan

4. Assesses for patient and family understanding of messages; when

distortions and misconceptions found, corrects them

Good Performance (3)

Does standard plus > 1 of following:

1. Repeats key message(s) throughout treatment period using various

methods (video, verbal, written)

Outstanding Performance (4) Does ALL Standard, Good, and Outstanding measures:

1. Tailors education to individual needs (culturally appropriate messages)

2. Provides "linguistically appropriate" written materials for reading level (e.g.,

pictures, stories, metaphor)

Georgia Tuberculosis Policy and Procedure Manual 2009

9/NA

186

CORE - Goal 7: Patient's Rights Protection

Protecting health care information rights of a patient, especially a minor, incapacitated,

or incompetent patient unable to make decisions.

Community's Rights Protection

Reduce M. tuberculosis transmission, protect exposed, and do not breach individual privacy

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Assesses for BOTH protection of individual health information rights and

protection of community health

2. Maintains privacy and confidentiality of health information consistent with

applicable federal laws and state codes

3. Assesses for environment conducive to private conversations between

patient, family, and nurse; moves to most appropriate site/conditions

4. Protects nature of, and reason for, field visit (e.g., does not use marked car,

wear ID badge, or carry items marked "TB program")

5. Assesses for TB transmission concerns; if contact investigation needed,

refuses to confirm contact's suspicions about source of possible TB exposure

6. Assesses need for patient to authorize (written contract) disclosure of

confidential information on a need-to-know basis

Good Performance (3)

Does standard plus > 1 of following:

Negotiates with patient about boundaries for release of confidential information

Outstanding Performance (4) Does ALL Standard, Good, and Outstanding measures:

Discusses, with other workers, standards for protecting health care information

while using medical interpreters, using photographs when names are unknown,

and conducting contact investigation

CORE - Goal 8: Mutual Goal Setting

9/NA

Identify and Prioritize Care Goals and Develop a Plan for Achieving Goals

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Assesses for presence of DOT indicators; when found, selects treatment

supporter for DOT

2. Assesses for potential treatment barriers; selects, with patient's input,

mutually acceptable enablers to overcome barriers; addresses patient-

centered approach in written plan

3. Reviews plan with patient and implements plan

4. Uses standard time frames for lab testing, x-rays, clinic visits, and DOT or

drug supply

Good Performance (3)

Does standard plus > 1 of following:

1. Occasionally reviews adherence barriers with patient

2. Reviews plan, enablers and/or incentives at least once

Outstanding Performance (4)

Does ALL Standard, Good, and Outstanding measures:

At each visit, reviews adherence barriers with patient

9/NA

CORE - Goal 9: Patient Contracting

Negotiating Mutual Agreement that Reinforces Specific Behaviors

Goal Attainment Level

Definition

Georgia Tuberculosis Policy and Procedure Manual 2009

Unacceptable Performance (0) Inadequate Performance (1) Expected or Standard Performance (2)
Good Performance (3) Outstanding Performance (4)

187
Substandard: Does NONE of Standard measures Substandard: Does > 1 but not all Standard measures Standard: Does ALL of following: 1. Outlines, verbally and in writing, patient, PHN, and field worker responsibilities so that each understands important details about how patient's TB will be managed: legal parameters, method of treatment administration, methods of airborne infection control, methods of communication (e.g., phone numbers) 2. Reinforces agreement on field visits, telephone calls, clinic visits 3. Outlines procedures to follow for medical assistance after hours and on weekends, holidays, etc. 4. Conveys acceptance, reassurance, concern, understanding, respect, and kindness 5. Negotiates incentives to reward successful accomplishment of treatment milestones 6. Presents written behavioral contracts for adherence with TB treatment and infection control measures in patient's primary written language for patient and provider signatures; provide final copy to patient Does standard plus > 1 of following: 1. Firmly negotiates feasible care options together 2. Establishes mutual trust with patient by avoiding power struggles Does ALL Standard, Good, and Outstanding measures: Obtains patient's explicit intention about taking TB medication

9/NA

CORE - Goal 10: : Medication Supervision/Management:

Facilitating Safe and Effective use of Prescription and Over-the-Counter Drugs

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Assesses for known allergies and drug-drug interactions; if needed, obtains

medical review immediately

2. Uses acceptable regimen: Assesses prescribed treatment for standard TB

regimen with correct drug dosages; ensures correct order and supplies

3. Assesses for nonstandard regimen and for nonstandard changes in TB

treatment; notifies physician & documents corrective response within 2

business days of notification

4. Records medication given, bacteriologic response, and adverse reactions

5. Assesses for adherence: determines compliance and verifies number of TB

treatment doses taken per week or month

6. At least monthly, assesses for adverse treatment events; notifies physician

& documents corrective response same day as symptoms identified and test

result received

7. At least monthly, acquires & uses assessment data and test results to

monitor, evaluate, and document response to therapy (positive, negative, or

absent responses)

8. Ensures that patient receives appointment reminders 2 business days

before clinic appointment for medical supervision

9. Acts to return patient to service within 2 business days of missed

appointment (e.g., DOT and clinic)

Good Performance (3)

Does standard plus > 1 of following:

Georgia Tuberculosis Policy and Procedure Manual 2009

Outstanding Performance (4)

188
1. Determines if provider is responsive to prescribing the standard TB treatment regimen; when provider is unresponsive to adjusting nonstandard treatment, immediately notifies expert TB physician by protocol 2. Assesses for nonstandard regimen and for nonstandard changes in TB treatment; notifies physician & documents corrective response within 1 business day of notification 3. Assesses for abnormal findings; if needed, monitors 2-3 times/month Does ALL Standard, Good, and Outstanding measures: 1. Assesses for nonstandard regimen and for nonstandard changes in TB treatment; notifies physician & documents corrective response same day as notification 2. Assesses for abnormal findings; if needed, monitors > 4 times/month

Goal 11: Discharge Planning Preparation for Moving a Patient who Needs Additional Treatment from one Provider Team to Another Within or Outside the Current Health Care Agency's Jurisdiction*

9/NA

Goal Attainment Level Unacceptable Performance (0) Inadequate Performance (1) Expected or Standard Performance (2)

Good Performance (3) Outstanding Performance (4)

Definition Substandard: Does NONE of Standard measures Substandard: Does > 1 but not all Standard measures Standard: Does ALL of following: 1. Each visit, verifies address and phone numbers (work, cell, home) where patient can be reached 2. Asks for name(s) and contact information of persons/places who will always know how to reach the patient (emergency contact information); identify hangouts 3. Obtains history of moves/travel during past 12 months and anticipated moves/travel during the next 12 months including stays in jails, nursing homes 4. At each visit, assesses for potential move before end of treatment and new location information 5. Ensures that standard referral information is immediately sent to receiving registry of patient's new residence AND to new provider(s) Does standard plus > 1 of following: 1. Assesses likelihood patient will seek care in new location 2. Assesses need to stay in touch by phone until new provider visit has been made 3. Assesses need to follow up with registry and new provider by phone and/or mail 4. Assesses need to check jail admission logs for patient's name if lost to follow-up Does ALL Standard, Good, and Outstanding measures: 1. Assesses need for transition medication during relocation to new provider 2. Assesses need for follow up with registry/new provider when it is time for the first drug dose/supply after the move

9/NA

CORE - Goal 12: Health Policy Monitoring

Surveillance for Influence of Regulations, Rules, and Standards

that Affect Nursing Systems, Performances, and Quality Patient Care

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Georgia Tuberculosis Policy and Procedure Manual 2009

Expected or Standard Performance (2)
Good Performance (3) Outstanding Performance (4)

189
Standard: Does ALL of following: 1. Discusses how case manager assists the patient with adherence to treatment (mutual goal setting, contracting, teaching, medication supervision, move planning, confidentiality of personal health information) 2. Discusses when case manager will recommend more restrictive measures in a prompt stepwise fashion (court-ordered DOT, court-ordered confinement) 3. Addresses poor adherence: Implements steps of escalating authority for individual with active TB disease who fails to follow TB treatment recommendations based on state TB control laws 4. Records monitoring activities 5. Appropriately applies regulations, rules, and standards related to dispensing, administering, and observing regulated drugs and administering TST Does standard plus > 1 of following: 1. Tailors regulations, rules, and standards related to administering TST, collecting sputum for mycobacteriology, and conducting phlebotomy procedures to best meet patient needs Does ALL Standard, Good, and Outstanding measures: Consults with other providers about carrying out regulations, rules, and standards related to TB treatment activities

9/NA

Goal 13: Infection Control

Minimizing Acquisition and Transmission of Infectious Agents

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

Ensures that persons with coughing symptoms are rapidly identified in TB

clinic. For those coughing,

1. Offers masks

2. Promptly separates to airborne infection isolation (AII) room

3. Assesses, obtains medical orders, and starts TB screening procedures as

recommended

4. Wears particulate respirator when in AII room

Good Performance (3)

Does standard plus > 1 of following:

1. Provides materials to persons who are coughing for adhering to respiratory

hygiene/cough etiquette

2. Assess how patient experiences TB isolation restrictions

Outstanding Performance (4) Does ALL Standard, Good, and Outstanding measures:

Tailors patient's teaching to their isolation experience

9/NA

Goal 14: Protection from Disease

Prevention and Early Detection of Infection or Disease in Patient at-Risk

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Assesses for index patient with confirmed/suspected pulmonary, laryngeal,

or pleural TB, AFB sputum smear or culture positive, or cavitary disease - high

priority for contact investigation (CI); when found, immediately starts CI

2. Ensures that CI resources are first provided for high priority contacts (< 5

Georgia Tuberculosis Policy and Procedure Manual 2009

Good Performance (3) Outstanding Performance (4)

190
yrs old and HIV+) 3. Counsels, tests, and refers index patient for HIV infection 4. Conducts first interview of index patient for contacts < 1 business day of reporting for high priority and < 3 business days for medium priority 5. Re-interviews the index patient in their home/setting for homeless < 2 weeks after the first interview for additional contact names and places 6. Continually observes index patient's environment for indications of additional contacts 7. Immediately refers contacts who live outside jurisdiction to appropriate health department for follow up 8. Assesses each contact for medical risk factors; if needed, expedites medical evaluation 9. Completes initial interview, testing, and evaluation of highest risk contacts <12 business days after identification, of high and medium risk contacts <17-24 business days after identification 10. For additional contact names, visit potential sites where unknown persons may have been exposed 11. Prepares a summary report of contacts
Does standard plus > 1 of following: 1. Uses system to track evaluation and treatment of all contacts 2. Assesses for clustering of cases; if found, alerts program manager
Does ALL Standard, Good, and Outstanding measures: Ask s index patient who will inform contacts of their need for medical evaluation; follows patient's preference when possible

9/NA

CORE - Goal 15: Surveillance

Coordinating Acquisition, Interpretation, and Synthesis of Patient Data

for Clinical Decision-Making

Goal Attainment Level

Definition

Unacceptable Performance (0) Substandard: Does NONE of Standard measures

Inadequate Performance (1)

Substandard: Does > 1 but not all Standard measures

Expected or Standard

Standard: Does ALL of following:

Performance (2)

1. Collects appropriate specimens and assessment reports within 2 business

days of pre-scheduled follow up dates on standard time frame (pathway) tool

2. Ensures that patient's assessment data and reports are systematically

collected, reported, and reviewed for abnormalities

3. Acquires assessment data and test result(s) for clinical decisions within 5

business days of pre-scheduled follow up dates

4. Verifies quality of patient's assessment data and reports

5. With each abnormal assessment and test result, promptly notifies physician

for medical review

Good Performance (3)

Does standard plus > 1 of following:

Acquires assessment data and test result(s) for clinical decisions within 3

business days of pre-scheduled follow up dates

Outstanding Performance (4) Does ALL Standard, Good, and Outstanding measures:

1. Acquires assessment data and test result(s) for clinical decisions in <1 day

of pre-scheduled follow up dates

2. Observes for and alerts program manager about new drug resistance

findings

Georgia Tuberculosis Policy and Procedure Manual 2009

191
Disclaimer: This document has not been tested for predictive validity and should not be used for disciplinary evaluation.
Goal Matrix Tool Self-Evaluation Scoring Sheet for Individual TB Case

Patient Identifier ______________________ Date Completed ___________ Evaluation type: ____Periodic
____Treatment Completion

Determine your performance by entering the information and performing the calculations in the

table below. Once you have determined your score, find the standard measure definition (Table 3).

1. Mark selected goal interventions ( / NA) in Table 2

2. Record your performance score, defined in Table 3, for each goal intervention. Determine if all

standard measures have been met. If yes, determine if good and outstanding measures have been

met. If no, determine how many standard measures have been met. Record this score (0-4) for

each goal in the Performance Score column (Table 1).

3. Total selected goals for this patient

______

4. Sum Performance Scores for selected goals

______

5. Divide Summary (line 4) by number of Selected (line 3) ______ Case Score

Table 2: Goal Measure and Performance Score Worksheet

/ NA Goal Intervention

Performance Score

1. Risk Identification (core)

2. Health Screening (core)

3. Culture Brokerage (core)

4. Sustenance Support

5. Emotional Support

6. Teaching of

disease process,

treatment regimen (core)

7. Patient's Rights Protection (core)

8. Mutual Goal Setting (core)

9. Patient Contracting (core)

10. Medication Management (core)

11. Discharge Planning

12. Health Policy Monitoring

13. Infection Control

14. Protection from Infection/Disease

15. Surveillance (core)

Total # Selected Goals

Summary Score: _____ Calculate Case Score:______

Table 3: Scoring Standard Measures

Calculated Case Score

Standard Measure Definition

0 No standard measures

Unacceptable

1 One but not all standard

Inadequate

measures

2 All standard measures

Standard / Expected

3 All standard measures + 1 Good

4 All measures met

Outstanding

Georgia Tuberculosis Policy and Procedure Manual 2009

192 Georgia Tuberculosis Policy and Procedure Manual 2009