SECTION 1

SECTION 1 INTRODUCTION

Tuberculosis Overview

TB is an airborne disease caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis). M. tuberculosis and seven very closely related mycobacterial species (M. bovis, M. africanum, M. microti, M. caprae, M. pinnipedii, M. canetti and M. mungi) together comprise what is known as the M. tuberculosis complex. Most, but not all, of these species have been found to cause disease in humans. In the United States, the majority of TB cases are caused by M. tuberculosis. M. tuberculosis organisms are also called tubercle bacilli.

The Role of the Health Department

Local health departments throughout the country assist in the following activities to reduce the transmission of tuberculosis disease:

Case Detection

New cases of infectious TB should be diagnosed and reported as early as possible in the course of illness so appropriate treatment can be initiated, transmission interrupted, and public health responses promptly initiated.

Case Management

TB case management includes assignment of primary responsibility for TB patients to public health staff, systematic regular review of patient progress, and development of plans to address barriers to patient adherence to therapy. An important component of TB case management is directly observed therapy.

Contact Investigation

In contact investigation, persons exposed to someone with active TB disease are identified and evaluated for TB disease and latent TB infection. Contacts are at high risk for latent TB infection, and if infected recently, are also at high risk for developing active TB disease. Contacts can be given treatment to reduce their risk of developing active TB.

Directly Observed Therapy (DOT)

Trained health care workers track all TB medication doses and observe TB patients take most doses of the prescribed drugs. DOT is the most effective strategy for ensuring patients take all of their medicine and complete full courses of appropriate therapy. DOT is the standard of care for all active TB patients in New York State.

Laboratory Services

Mycobacteriology laboratories confirm the diagnosis in persons with active TB disease and aid in assessing patients' infectiousness and response to TB therapy.

Targeted Testing and Treatment of Latent TB Infection

Targeted testing identifies those at highest risk for progression from latent TB infection to active TB disease who may benefit most from treatment. Priorities include persons at risk due to certain medical conditions, as well as those who live in settings or communities, or have emigrated from countries where TB is more prevalent.

S2AY Network Tuberculosis Manual

Last Revision June 20, 2017

PH Committee Approved June 19, 2018

1

Prevention of TB transmission in Healthcare Settings

Comprehensive infection control includes:

· Administrative controls - procedures for detecting and managing persons with possible active tuberculosis disease and for education and screening of health care workers

· Environmental controls - appropriate use and maintenance of airborne infection and isolation rooms and other ventilation measures

· Respiratory-protection controls - appropriate use of respirators in settings with increased risk for TB exposure

(See S2AY Network Infection Control Exposure Plan for additional guidance and MMWR Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health Care Settings.)

2

SECTION 2 TELEPHONE INQUIRIES AND NYSDOH CONTACTS

· All telephone calls and incoming referrals related to tuberculosis will be referred to TB Coordinator/designee.

· Consultation with the NYSDOH Regional TB Representative is available, as needed:

· Buffalo Regional Office: 716-847-4500

· Rochester Regional Office 585-423-8100

· NYSDOH TB Program in Albany: 518-474-4845

· NYSDOH Rochester Regional Contact:

Angel Cardona

Western Region TB Coordinator

335 E Main St.

Rochester, NY 14604

Phone 585-423-8059 (office)

Fax 585-423-8108

Email angel.cardona@health.ny.gov

3

SECTION 3 TESTING METHODS FOR TB INFECTION

There are two methods to screen for TB infection. Selection of the most suitable test should be based on the reasons and the context for testing, test availability, and overall cost effectiveness of testing. A negative reaction to any of these tests does NOT exclude a diagnosis of latent TB infection or Active TB disease. The decision about medical or public health management should include epidemiological, historical, and other clinical information. Decision should not be based on Tuberculin Skin Test (TST) or Interferon Gamma Release Assay (IGRA) alone.

Tuberculin Skin Tests:

· The Mantoux tuberculin skin test (TST) is used to determine whether the person is infected with M. tuberculosis. In this test, intermediate strength PPD (Purified Protein Derivative, containing 5 tuberculin units or TU) is injected under the skin intradermally. In most people who have TB infection, the immune system will recognize the PPD because it is extracted from the tubercle bacilli that caused the infection. It takes 2 to 8 weeks after initial infection with M. Tuberculosis for the immune system to be able to react to PPD and for the infection to be detected by TST.

Tubersol is the tuberculin solution widely recommended for Tuberculin skin testing. It is recommended that Aplisol only be used during a shortage of Tubersol as Aplisol has a history of false positive reactions.

TB Blood Tests:

NOTE: Per CDC, IGRA is preferred for persons who have received BCG vaccine and for people who may have a difficult time returning to have the TST read. A person’s health care provider should choose which TB test to use. Factors in selecting which test to use include the reason for testing, test availability, and cost. Generally, it is not recommended to test a person with both a TB skin test and a TB blood test.

· The Interferon Gamma Release Assay/IGRA

· QuantiFERON-TB Gold In-Tube

· T-Spot TB Test

IGRA’s should generally not be used for testing children younger than 5 years of age unless used in conjunction with a TST.

NOTE: See MMWR Updated Guidelines for Using the QuantiFERON-TB Gold Test for Detecting Mycobacterium tuberculosis Infection 2010 for more information https://www.cdc.gov/mmwr/pdf/rr/rr5415.pdf

AND/OR

See MMWR Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection — United States, 2010

http://www.cdc.gov/mmwr/pdf/rr/rr5905.pdf

https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm

See chart on following page for a comparison of TST and IGRA

Centers for Disease Control and Prevention. (2013, 6th ed). Core curriculum on tuberculosis: What the clinician should know. Retrieved June 30, 2014

Identifying Candidates for TB Skin Testing

General population TB testing is not recommended. Targeted tuberculin testing is aimed at identifying individuals at high risk for developing TB who would benefit from treatment of latent TB infection. This includes:

· Known close contacts of a person with infectious TB disease.

· Persons who have immigrated from TB-endemic regions of the world.

· Persons who visit areas with a high prevalence of TB disease, especially if visits are frequent and prolonged.

· Persons who work or reside in facilities or institutions with people who are at high risk for TB, such as hospitals that care for TB patients, homeless shelters, correctional facilities, nursing homes, or residential facilities for patients with HIV infection/AIDS.

· Persons with HIV infection.

· Immunosuppressed persons including persons who take prolonged use of corticosteroids or other immunosuppressive agents such as TNFα (Tumor Necrosis Factor) antagonists (i.e., Humera).

Screening Candidates for TB Skin Testing

All candidates for TB skin testing will complete a TB Skin Test Consent and Questionnaire (see Appendix 1). The screening questionnaire is designed to assist the nurse in identifying potential reasons NOT to perform testing.

Screening Question

Considerations

Can you return in 48 to 72 hours to have your TB skin test read?

The TB test cannot be read before 48 hours or after 72 hours from placement. The nurse should ensure that the individual can have the test read by a health care professional during the appropriate time frame, prior to test placement.

Have you ever had blistering or a serious reaction to a tuberculin skin test?

Allergy to any component of the TST or an anaphylactic or other allergic reaction to a previous test is a contradiction.

Are you sick today?

TST should be deferred for persons with a major viral or bacterial infections.

Have you ever had a positive TB skin test?

Individuals with a history of a positive TB test should not receive another test if they can provide documentation. The classifications of a ‘positive’ test take into consideration both the millimeter measurement of induration and the person’s risk factors at the time of testing.

Are you in contact now or have you ever been in contact with a person diagnosed with Tuberculosis?

Is this person currently part of a contact investigation? Are they or were they ever part of contact investigation? Do you need to reach out to other LHD’s?

Do you currently have any of the following symptoms:

· Fever

· Night sweats

· Weight loss

· Persistent cough

· Coughing up blood

· Tiredness

Any person with signs and symptoms suggestive of TB must be considered a suspect case until TB is definitely ruled out.

Have you had any of the following vaccines within the past 4 weeks:

· Measles, Mumps, Rubella (MMR)

· Chicken Pox or Shingles (Varicella/Zostavax)

· Oral Polio

· BCG

· Oral Typhoid

· Small Pox

· Yellow Fever

· Flu-Mist (Nasal influenza vaccine)

· Human Rabies Immunoglobulin

Individuals who have recently been immunized with a live-virus vaccine should not receive a tuberculin skin test until a full month has elapsed since the vaccination, because of a possible false negative due to anergy. A live virus vaccine can be administered the same day a TST is placed.

Do you have a history of fainting?

This is a patient safety issue. Patients should be monitored and requested to remain seated for 15 minutes.

Other considerations for TB Skin Testing

· Pregnancy is not a contraindication for skin testing.

· A history of Bacille Calmette-Guerin (BCG) vaccination is not a contraindication for skin testing. However, it should be recorded since it is relevant to the interpretation of test results.

· Note: Steuben County will pay for persons with a history of BCG vaccination to have IGRA testing at Noyes Hospital. See Protocol for Testing for TB for Immigration-see Appendix 1

· Testing in Infants: There is no age contraindication to TST of infants. Because their immune systems are immature, many infants less than 6 weeks of age who are infected with TB do not react to Tuberculin tests. Older infants and children develop tuberculin sensitivity three to six weeks or more after initial infection.

· Skin tests in HIV positive individuals may not accurately identify TB infection. Non-significant results (< 5mm) are more likely to occur later in the course of HIV infection, as immune status deteriorates. Therefore, a non-significant skin test reaction in a HIV positive person does not rule out the possibility of tuberculosis infection.

Technique of administering a TB Skin Test

General Information

· Adhere to Standard Precautions in the S2AY Network Infection Control Exposure Plan whenever administering TST.

· A short (1/2 inch) 26 or 27 gauge needle should be used. A sterile (preferably safety engineered) TB syringe and needle must be used for each injection. Because the tuberculin solution can be absorbed by plastic, the syringe should be filled immediately before using, with 0.1 ml of PPD tuberculin containing 5 TU (tuberculin units).

· Tuberculin solution is sensitive to light and should be stored in its original box.

· The standard site is the volar surface of the forearm, one third of the way from the elbow toward wrist. If neither arm is available or acceptable for testing, the back of the shoulder is a good alternative tuberculin testing site. Scars, moles, etc. should be avoided. The specific location of the site used will be recorded.

· Once the vial containing the tuberculin solution is opened, label with date and initial. The open vial must be discarded one month after open date or by expiration date whichever is sooner.

· Only use tuberculin solution that is clear and without discoloration.

7

Administering the Tuberculin Skin Test

Equipment/Supplies Needed:

8

· Sterile TB syringe

· Alcohol Swabs

· Cotton Balls

· Tubersol/Aplisol

· Sharps Container

Procedure:

· Ensure consent has been obtained and all screening questions are answered and reviewed using the TB Skin Test Consent and Questionnaire (see Appendix 1). If parent is unable to be present during administration of a TST, the Consent and Questionnaire can be provided in advance, to be completed and signed by the parent/guardian. Form must be brought to the appointment (see Appendix 4 for letter to parent regarding consent for child).

· Explain the procedure to the patient

· Cleanse hands per agency approved policy

· Assemble equipment

· Inspect the tuberculin solution. Ensure expiration date is not exceeded

· Draw up 0.1ml of tuberculin solution

· Cleanse the site with alcohol

· Allow the site to dry completely before the injection

· The skin should be stretched taut and the injection made just beneath the surface, with the needle bevel facing upward, to produce a discrete wheal, 6-10 millimeters (mm) in diameter, by measurement. The tuberculin solution should not leak onto skin surface; this indicates too shallow of an injection. Injecting too deep produces no wheal, and may result in an induration which cannot be accurately measured.

NOTE: If it is recognized that a test was improperly administered, another test dose shall be given immediately. Replacement site needs to be at least two inches away from the previous one so that there would be no overlap of any resulting induration. (This procedure could be repeated more than once if necessary; it would not harm the patient.) The location of the correctly administered test must be recorded.

· If the injection site bleeds, blot the blood away gently using a cotton ball.

· Do not cover the site

· Dispose of soiled supplies appropriately

· Cleanse hands per agency approved policy

· Instruct the patient to avoid scratching the site or applying creams/lotions. Remind the patient to have the test read between 48 and 72 hours. You may provide the patient with the Centers for Disease Control handout, What You Need to Know About the TB skin Test. Record the time and date the individual needs to have the test read. If the individual will have the test read by a health care professional outside of the local health department, the nurse shall provide the individual with a copy of the TB Skin Test Consent and Questionnaire (Appendix 1).

· Document the following on the TB Skin Test Consent and Questionnaire (Appendix 1):

· Date placed

· Time placed

· Site

· Manufacturer

· Lot #

· Expiration Date

· Name and Title of administering nurse

Reading the Tuberculin Skin Test

Time frame: The test must be read 48 to 72 hours after the injection by a Health Care Professional only. Any earlier response may indicate allergy rather than TB infection. After 72 hours the response may fade somewhat; however, significant reactions may still be measurable up to one week after testing.

Measurement: Induration is a hard, dense, raised formation. Measure ONLY induration not swelling or erythema. The diameter of induration should be measured from the thumb side to the little finger side and recorded in millimeters. If induration is present, it is recommended to outline the margins and mark with a dot using a pen. Using a millimeter ruler, place the zero on the inside of the left dot and read the ruler line inside the right dot edge. Read skin tests placed on the back of the shoulder from all directions.

Document the following on the TB Skin Test Consent and Questionnaire (Appendix 1):

· Date and time of the reading

· Measurement must be documented in millimeters

· Other Adverse Reactions (i.e., redness, swelling, blistering, necrosis)

· Signature and Title of the Health Care Personnel reading the test

Interpreting the Tuberculin Skin Test Results

General Information

· History of BCG vaccine: CDC recommends that IGRA be used for persons with a history of BCG vaccine. TST sensitivity caused by BCG tends to wane with time; especially if there have been no recent skin tests to boost it. The size of a TST reaction in a BCG-vaccinated person is not a factor in determining whether the reaction is caused by LTBI or the prior BCG vaccination.

https://www.cdc.gov/tb/publications/factsheets/prevention/bcg.htm

· Use of steroids may result in a reduced immune response, causing a false negative reaction.

· Acute viral or bacterial infection may result in a false negative reaction.

Interpretation of TST reactions depends on the measurement (in millimeters) of induration and the person’s risk of acquiring TB infection or the risk of progression to TB disease if infected.

Taking this into account, three cut-off levels have been recommended for defining a positive TB reaction:

Individuals in the following groups who have a TST equal to or greater than 5mm of induration are considered to have a positive TB Skin Test. They should be evaluated to rule out active TB disease and once active TB disease is ruled out, they may be candidates for latent TB therapy:

· HIV-infected persons

· Recent contacts of a person with infectious TB

· Persons who have chest radiograph findings suggestive of previous TB

· Person with organ transplant(s) and other immuno-suppressed persons (including patients taking the equivalent of ≥ 15mg/day of prednisone for 1 month or more or those taking TNF –o antagonists.

Individuals in the following groups who have a TST equal to or greater than 10 mm of induration are considered to have a positive TB Skin Test. They should be evaluated to rule out active TB disease and once active TB disease is ruled out, they may be candidates for latent TB therapy:

· A conversion from a non-significant test to a significant test within a two year period.

· Persons with certain medical conditions that increase the risk for progression to TB disease, such as silicosis, diabetes mellitus, chronic renal failure, certain types of cancer and some intestinal conditions

· Injection drug users

· People who have come to the US within the last 5 years from areas of the world where TB is common (i.e., Asia, Africa, Eastern Europe, Russia, or Latin America)

· Mycobacteriology laboratory personnel

· Residents and employees of high risk congregate settings (e.g., correctional facilities, nursing homes, hospitals, homeless shelters)

· Children younger than 5 years of age

· Infants, children and adolescents exposed to adults in high risk categories

Individuals with no known risk factors for TB who have a TST equal to or greater than 15 mm of induration are considered to have a positive TB Skin Test. They should be evaluated to rule out active TB disease and once active TB disease is ruled out, they may be candidates for latent TB therapy.

NOTE: At the end of this section, see the excerpts from the CDC regarding classifications of TST reactions.

Booster Testing (Two Step):

Candidates:

People who will be receiving periodic skin tests, such as health care personnel, should receive a booster test upon initial screening, unless they have documentation that they received a skin test in the previous year. This is a strategy used to reduce the likelihood that a booster reaction will be misinterpreted as a recent infection.

Method:

If the initial skin test for such an individual is not significant (depending on risk factors) the test should be repeated, preferably in the opposite arm (again using 0.1 ml, 5 TU) from 1-3 weeks later. The reading from the second test is recorded as the true baseline for the individual.

Education:

Everyone examined should be appropriately educated about the test, the necessity of returning to have it read, what the result means, and the need for any further testing. Anyone with a positive test based on millimeters of induration and their risk factors should be instructed to avoid any future testing. These individuals are a candidate for treatment and should be referred to the TB program. The rationale for avoiding additional skin testing in candidates for treatment will be provided. Individuals with millimeters of induration and risk factors that do not qualify them as candidates for treatment will be instructed that they can receive future TST’s. There is no need for them to be specifically retested. These individuals should receive information about the signs and symptoms of TB.

11

Latent Tuberculosis Infection: A Guide for Primary Health Care Providers, CDC, 2013.

(Page 7 referenced above refers to a CDC guidance document containing information already discussed in this manual).

S2AY Network Tuberculosis Manual

Last Revision September 15, 2015

PH Committee Approved July 19, 2016

12

SECTION 4 PATHOGENESIS OF TUBERCULOSIS

M. tuberculosis is carried in airborne particles, called droplet nuclei, of 1-5 microns in diameter. Infectious droplet nuclei are generated with a person with pulmonary or laryngeal TB disease coughs, sneezes, shouts, or sings. Depending on the environment, these tiny particles can remain suspended in the air for several hours. M. tuberculosis is NOT transmitted by surface contact. Transmission occurs when a person inhales droplet nuclei containing M. tuberculosis, and the droplet nuclei traverse the mouth or nasal passages, upper respiratory tract, and bronchi to reach the alveoli of the lungs.

People who are exposed to TB may or may not develop latent TB infection (LTBI) or Active TB disease. See chart below for the progression of TB (CDC, 2013, Core Curriculum)

SECTION 5 EVALUATING PERSONS WITH POSITIVE TB TEST RESULTS

All individuals with a positive TB test result (positive TST or IGRA) should be evaluated to rule out Active TB disease.

NOTE: Determining positive TST results requires an evaluation of the mm’s of induration and the patient’s risk factors (See Section 3 of this manual)

· Referrals typically come from physician’s offices, hospitals, urgent care clinics, or are identified at the LHD’s clinic.

· Upon receipt of a referral, VERIFY COUNTY OF RESIDENCE. If the patient does not reside in your county, instruct the referral source to contact the patient’s county of residence. If the patient is identified as part of the LHD clinic and NOT a county resident, consult with the patient’s LHD.

· Obtain Medical History using the TB Initial Assessment Form (Appendix 2)

· Symptom Review for pulmonary TB (TB disease usually caused one or more of the following:

· Cough (especially if lasting for 3 weeks or longer) with or without sputum production

· Hemoptysis (coughing up blood)

· Chest Pain

· Loss of appetite

· Unexplained weight loss

· Night Sweats

· Fever

· Fatigue

NOTE: If the patient is symptomatic, they should be evaluated by a physician to rule out active TB. (See section 7 on Suspected Cases of TB)

· History of prior treatment for LTBI or TB disease. If patient has a history of previous Tuberculosis diagnosis and/or treatment, a History Form will be completed by TB Control Nurse (see Appendix 3 for Tuberculosis History Form).

· Determining co-existing medical conditions

· Current medications including any adverse reactions to medications

· Non-symptomatic county residents should be encouraged to attend TB clinic or follow-up with their primary care provider. See Process for Asymptomatic Clients-Appendix 5

· All patients will be provided with education on latent and active TB disease. The Department’s Interpretive Services will be used when communicating with non-English speaking patients. Written educational materials are available from the Centers for Disease Control and Prevention (CDC) in numerous languages.

· HIV information and education will be provided to all patients. HIV testing will be encouraged.

· Every person evaluated with a positive TB test should receive a chest X-ray as part of the initial examination. The TB Control Nurse will coordinate with the physician and patient to arrange for and obtain x-rays, when indicated.

NOTE: Permission to x-ray pregnant women must be obtained from the county/patient’s physician, who may consult with patient’s private obstetrician/family practitioner. This permission must be noted in the patient’s record. A lead shield is routinely ordered on women of childbearing age.

Centers for Disease Control and Prevention. (2013, 6th ed). Core curriculum on tuberculosis: What the clinician should know.

SECTION 6 LATENT TB INFECTION (LTBI)

General Information

· Latent tuberculosis infection occurs when a person inhales droplet nuclei containing tubercle bacilli that reach the alveoli of the lungs.

· Once in the alveoli the tubercle bacilli multiply.

· A small number of tubercle bacilli may enter the blood stream and spread throughout the body. The tubercle bacilli may reach any part of the body, including areas where TB disease is more likely to develop (such as the brain, larynx, lymph node, lung, spine, bone, or kidney).

· Within 2 to 8 weeks, the individual’s immune system ingests and surrounds the tubercle bacilli. Macrophages form a barrier shell (granuloma), the keeps the bacilli contained and under control. The establishment of this granuloma (encapsulating the tubercle bacilli) is known as Latent TB Infection.

· People with LTBI do not have TB disease and cannot spread the infection to others.

· The CDC estimates roughly 10% of people with latent TB infection will progress to TB disease at some time in their life.

Encouraging treatment for LTBI is an important element of LHD TB prevention:

· All Latent TB infected persons should be encouraged to receive services through the County TB Program. Treatment for Latent TB is voluntary.

· If the individual receives services through the County TB Program, provide education/information including:

· Patient bill of rights; Agency privacy statement; consent for treatment, payment and healthcare operations, including confidentiality, and release of information (see Administrative Manual: Evaluation, Admission and Discharge Policy). Note: If patient is not admitted, he/she does not sign need to sign the Consent for treatment, payment and healthcare operations

· Treatment for LTBI should never be started until active disease has been completely ruled out and physician has determined that patient is a candidate for treatment.

· Liver function tests may be performed prior to start of treatment and as ordered by physician. Generally those patients less than 35 years of age will not warrant baseline liver function tests. If symptoms suggesting an adverse reaction occur, appropriate laboratory testing should be performed. Consult with PCP/TB consultant.

· All LTBI candidates should also be educated on age appropriate immunizations and encouraged to receive needed immunizations.

· If a patient has a positive TB test and is X-ray negative, and declines treatment, the patient will be provided with education regarding disease process, medication and ability to receive treatment in the future. A Declination for LTBI Treatment Letter (see Appendix 4 for sample Declination Letter) will be sent to the patient and their provider(s).

· Treatment for Latent TB Infection: See the most recent Centers for Disease Control and Prevention Latent Tuberculosis Infection: A Guide for Primary Health Care Providers found at: http://www.cdc.gov/tb/publications/LTBI/treatment.htm

Isoniazid-Rifapentine Regimen

Isoniazid (INH) and Rifapentine (RPT) administered weekly for 12 weeks as directly observed therapy (DOT) is acceptable as an equal alternative to the 9 month INH regimen for otherwise healthy patients aged >12 years who have LTBI and factors that are predictive of TB developing. Considerations for this regimen include feasibility of completing DOT, drug availability, expectance of treatment completion, patient and MD preferences. See following MMWR Recommendations for Use of an Isoniazid-Rifapentine Regimen with Direct Observation to Treat Latent Mycobacterium tuberculosis Infection, December 9, 2011/60(48);1650-1653

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6048a3.htm?s_cid=mm6048a3_w

· The County TB Program will assist patient with obtaining prescribed medication(s):

· The TB Control Nurse/Designee will assess medication compliance and tolerance monthly for all patients and will appropriately document (see Appendix 5 for sample Tuberculosis Preventive Treatment Record).

· All patients will receive education regarding medication(s), dose, frequency, possible side effects and when to notify TB Control Nurse or Physician (see Appendix 6 for sample medication information sheets).

· Patient compliance is the key to success of any treatment regimen.

· Efforts must be made to maximize voluntary compliance.

· Approved incentives may be used to enhance compliance (i.e., gas cards, food cards, stickers, theater coupons, calendars, etc.)

· Often taking medication with meals or at bedtime can resolve minor problems involving nausea. Educating patients to take the medication in conjunction with some enjoyable part of their daily schedule is another possible approach.

· It is important to follow up suspected noncompliance, including missed appointments, promptly so that lapses in treatment are minimized. DOT for LTBI can also be considered for non-compliant patients.

· If a patient misses a MD appointment, the TB Control Nurse will contact the patient to ascertain reason and reschedule the appointment.

LTBI Program Discharge:

· Transfer to another jurisdiction prior to completion of LTBI treatment:

Interjurisdictional TB Notification (IJN) Form is used to notify State and Local Health Departments of TB patients moving from one state to another or from one county to another within New York State.

If a patient is moving to another state or New York City, the IJN Form is faxed to (518) 408-1941 or sent via secure file transfer on the Health Commerce System (HCS) to Michelle.Cummings@health.ny.gov at BTBC Data Unit.

If a TB patient is moving from one county to another within New York State, the IJN Form is faxed or

sent via secure file transfer on the HCS to the Local Health Department of the patient’s new county of

residence with an additional copy faxed to (518) 408-1941or sent via secure file transfer on the HCS

to Michelle.Cummings@health.ny.gov at the BTBC Data Unit.

See New York State Tuberculosis Forms Manual.

· Completion of LTBI treatment: Persons completing a recommended course of treatment for LTBI will be discharged from the local health department with instructions to call their health care provider or their local health department if they develop symptoms that could be caused by TB. Completion of LTBI treatment is defined by number of ingested doses within specified time frame.

A LTBI treatment completion letter will be sent to patient with a copy sent to the patient’s primary care provider and/or consultant specialist. This letter should be provided in the patient’s spoken language with attention to literacy level. The letter will include a list of TB symptoms, instruction to

contact the local health department or PCP with any concerns, and clarification that their TST skin test will always remain positive and that they should not receive further TSTs.

(See sample LTBI Treatment Completion Letter in Appendix 4 of this manual)

· Non-Completion of LTBI Treatment: Persons not completing a recommended course of treatment for LTBI will be discharged from the local health department with instructions to call their health care provider or their local health department if they develop symptoms that could be caused by TB. Reasons for non-completion may include:

· Lost to follow-up

· Medical necessity

· Voluntarily chose to discontinue

A LTBI Non-Completion Letter will be sent to the patient with a copy sent to the patient’s primary care provider and/or consultant specialist. This letter should be provided in the patient’s spoken language with attention to literacy level. The letter will include a list of TB symptoms, instruction to contact the local health department or PCP with any concerns, and clarification that their TST skin test will always remain positive and that they should not receive further TSTs. The letter will address TST date and findings, chest x-ray date and findings, treatment start and end date, medication type, dose, number of doses received and duration, reason for discontinuation of therapy.

(See sample LTBI Non-Completion Letter in Appendix 4 of this manual)

SECTION 7 SUSPECTED CASES OF TUBERCULOSIS

Classification System

The current clinical classification system for TB is based on the pathogenesis of the disease. A patient should not have a class 5 classification (diagnosis pending) for more than 3 months.

All persons with class 3 or class 5 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.

Class

Type

Description

0

No TB exposure

Not infected

No history of exposure

Negative reaction to tuberculin skin test or IGRA

1

TB exposure

No evidence of infection

History of exposure

Negative reaction to tuberculin skin test or IGRA (given at least 8-10 weeks after exposure)

2

TB infection

No disease

Positive reaction to tuberculin skin test or IGRA

Negative bacteriologic studies (if done)

No clinical, bacteriological or radiographic evidence of active TB

3

TB, Clinically Active

Positive culture for M. tuberculosis OR

Positive reaction to TST or IGRA plus clinical, bacteriological or radiographic evidence of current disease

4

TB, Not Clinically Active

History of episode(s) of TB

no

Abnormal but stable radiographic findings

Positive reaction to the tuberculin skin test or IGRA

Negative bacteriologic studies (if done)

and

No clinical or radiographic evidence of current

disease

5

TB suspected

Diagnosis pending

Signs and symptoms of active TB disease but medical evaluation not complete

SUSPECT CASE (CLASS 5, NOT YET CONFIRMED)

Criteria: Any person with signs and symptoms suggestive of TB must be considered a suspect case until TB is definitely ruled out.

· Any person with a laboratory report positive for unidentified acid-fast bacilli (AFB+) is a TB suspect until ruled out.

· Any person with a positive laboratory report positive Nucleic Acid Amplification (NAA) for M.tuberculosis or M.tuberculosis complex is a suspect until ruled out.

· Other signs/symptoms of active TB include fever, chills, night sweats, easy fatigability, weight loss, anorexia, cough.

· Abnormal chest x-ray consistent with TB.

· Positive tuberculin test. NOTE: A negative tuberculin test does not exclude a diagnosis of TB disease or latent TB infection. A case of tuberculosis may be so severe that the immune system is overwhelmed, causing anergy. Anergy is the inability to react to a TB skin test because of a weakened immune system. Severe infections and immune-deficiencies can cause anergy and the inability to react to a tuberculin skin test.

· HIV INFECTION

· Tuberculosis may have an unusual clinical picture in the presence of HIV infection; extra-pulmonary TB, particularly lymphatic or disseminated disease, is frequently seen.

· Individuals with HIV infection are more likely to progress to active TB disease.

· Because the treatment recommendations for patients with HIV infection are different than for those without, it is necessary to evaluate the risk of all patients for HIV infection, and refer or test them as appropriate.

· Chest x-rays are difficult to interpret in HIV-infected patients. When both TB and HIV infection are present:

· Cavitation is uncommon.

· Infiltrates may appear in any lung zone.

· Hilar and/or mediastinal adenopathy is common.

· Other pulmonary disease may be present in addition to TB.

INCOMING REFERRALS FOR SUSPECT TB CASES

· Providers should report Suspect TB Cases to the county within 24 hours of identification, by telephone.

· All incoming referrals are to be investigated immediately, without waiting for culture results. Investigation may be discontinued if/when TB is ruled out. Referrals may include:

· DOH 389/DC-103’s from hospitals, private physicians etc. (See NYS Tuberculosis Forms Manual).

· Lab reports of AFB positive smears and positive Polymerase Chain Reaction (PCR).

· Telephone reports of TB suspect cases.

· Interstate Reciprocal Notification of Disease forms (See NYS Tuberculosis Forms Manual).

· Refugee referrals (B1 and B2 Form) should be considered suspect cases until proved otherwise.

· Any incoming TB information should be directed to TB Control Nurse/Designee.

· The evaluation of a newly identified suspect TB case should include all of the following:

· Complete the Initial TB Assessment form (Appendix 2)

· Complete a TB History Form, if applicable (Appendix 3)

· Obtain results or arrange for a screening test for M. tuberculosis infection (see Section 3)

· Obtain results or arrange for chest X-ray

· Permission to x-ray pregnant women must be obtained from the county/patient’s physician, who may consult with patient’s private obstetrician/family practitioner. This permission must be noted in the patient’s record. A lead shield is routinely ordered on women of childbearing age.

· X-ray interpretation in patients with HIV infection/AIDS: Many patients with tuberculosis and HIV/AIDS infection have x-rays which do not show the granulomatous tissue reaction and cavitation typical of TB in patients with normal immune systems. Infiltrates and hilar or mediastinal adenopathy are often seen in HIV infected or AIDS patients.

· Obtain results or arrange for bacteriologic examination - see Bacteriology for Suspect TB Cases section below.

· Record patient information on Suspect/Active TB Case Log (see Appendix 7).

· In consultation with the TB Consultant or Primary Care Provider, medication therapy may be initiated pending culture results (See the IDSA Guidelines – Official American Thoracic Society / Centers for Disease Control and Prevention / Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis, August 10, 2016. http://www.cdc.gov/tb/publications/guidelines/pdf/clin-infect-dis.-2016-nahid-cid_ciw376.pdf) If medication therapy is started, patient will complete the Agency admission process (see Administrative Manual: Evaluation, Admission and Discharge Policy).

· TB Control Nurse/Designee will provide patient education including:

· TB Disease

· Diagnostic procedures and treatment

· Treatment duration, expectation of cure, importance of compliance

· Medication side effects

· Transmission

· Airborne spread; fomites not involved

· Ventilation; covering coughs

· Contact investigation, including prophylaxis and baseline and follow-up testing (8-10 weeks later) of all contacts

· Possible need for quarantine

· Importance of HIV testing

BACTERIOLOGY FOR SUSPECT TB CASES

INITIAL BACTERIOLOGY

Three successive single volume sputum specimens should be collected from each suspect/confirmed pulmonary TB case 8-24 hours apart with one in early morning. It is desirable that the first sputum specimen be obtained under supervision. Patients should be coached to produce a better sputum specimen by breathing deeply, with maximum expiration, 5 or 6 times, then taking the deepest possible breath, coughing hard and down deep, then immediately following through by clearing the throat, and putting the sputum or throat-clearings into the specimen bottle. Patient will be instructed to date and time specimen bottle and refrigerate after specimen is obtained. Written instructions given with the specimen container can reinforce this. If the patient does not have a productive cough aerosol induction may be ordered by the physician.

For extra-pulmonary symptoms additional appropriate specimens, such as urine, should be examined.

All should be examined both microscopically (smear for acid-fast bacilli, [AFB]) and by culture.

CDC recommends that nucleic acid amplification test (NAA) testing be performed on at least one respiratory specimen from each patient with signs and symptoms of pulmonary TB 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 investigations. NAA tests are used to amplify DNA and RNA segments to rapidly identify the microorganisms in a specimen. NAA testing can reliably detect M. tuberculosis bacteria in specimens in hours as compare to 1 week or more for cultures. (CDC, Core Curriculum, 2013).

Culture examination should be done on all diagnostic specimens, regardless of AFB smear or NAA results.

Smear positive sputum specimens should be sent to Wadsworth Center for Laboratories & Research in Albany, NY. Utilize Wadsworth “Fast Track” system for positive smears. Consult Wadsworth TB Lab and/or NYSDOH Regional Representative for instructions. A supply of mailers is available to each Public Health Nursing Office, if needed. (See attached Wadsworth Center TB Fast Track and Sputum Specimens directions, Instructions for Shipping Specimens and Isolates, Diagnostic Mailer Instructions, and the NYSDOH Infectious Disease Requisition.)

Subsequent sputum specimen may or may not be sent to Wadsworth laboratory. Wadsworth laboratory will provide guidance. Local hospital laboratories may be utilized.

The possibility exists that a suspect TB patient is unable to produce sputum specimens for culture. Based on clinical presentation, physicians may make the diagnosis of active TB if the patient is improving while on two or more TB drugs. See Section Eight for Active Confirmed Cases.

22

MONITORING PATIENT FOR COMPLIANCE

COMPLIANCE

Suspect TB cases receiving medication therapy will be placed on directly observed therapy (DOT) to ensure compliance with the drug regimen (see Section 9 for DOT guidance). Those in a closely monitored setting (as a nursing homes, proprietary home, jail, school, etc.) will receive DOT by facility staff.

Documentation should be maintained utilizing DOT Client Log (see sample Appendix 8). If DOT is performed in a monitored setting, some form of documentation should be maintained in patient’s chart.

Patients on daily therapy will receive a visit each weekday. The TB Control Nurse/designee will ensure that the patient understands how to take the weekend and/or holiday doses of medication. At the next scheduled home visit, the TB Control Nurse or designee will monitor weekend/holiday compliance closely (example, pill count).

Patient compliance is important until culture results rule out Active TB. Efforts must be made to maximize voluntary compliance. Approved incentives may be used to enhance compliance. It is important to follow up suspected noncompliance, including missed appointments, promptly so that lapses in treatment are minimized. If a patient misses a MD appointment, the TB Control Nurse will contact the patient to ascertain reason and reschedule the appointment.

RECEIPT OF CULTURE RESULTS

· Culture results negative for mycobacterium TB and all other nontuberculosis mycobacterium:

· The patient does not have M.tb and can be discharged.

· Patients with nontuberculosis mycobacterium may continue medication therapy under the direction of their PCP, and will not require DOT.

· Culture results positive for mycobacterium TB – see Section Eight of this manual.

31

SECTION 8

CONFIRMED ACTIVE TUBERCULOSIS (Class 3)

Criteria: A confirmed TB case is one of the following:

· Any case with culture results reported as positive for M.tuberculosis

NOTE: the initial M.tuberculosis isolate should be tested for resistance to the first line anti-TB drugs (isoniazid, rifampin, ethambutol and pyrazinamide).

· A case without culture confirmation, but on two or more TB drugs and improving clinically, who is diagnosed as an active TB case by a physician (on the basis of evidence such as a positive tuberculin test plus abnormal X-ray, etc.)

Special Considerations:

· CHILDREN

· An infant born to a mother with active disease should have a baseline x-ray and should be placed on INH prophylaxis immediately and evaluated by tuberculin test and x-ray at the age of 6 months. (The exact timing of the examination depends on when the mother became noninfectious because of adequate treatment.) The mother and infant need not be separated.

· WOMEN OF CHILD-BEARING AGE

· Lactation: Breast feeding while being treated for TB should not be discouraged. Anti-tuberculosis drugs are found in breast milk, but in concentrations too low to either cause toxicity in the infant or provide effective treatment. However, if the infant is being treated directly with anti-tuberculosis drugs, termination of breast-feeding may be considered since breast milk, which also contains the drugs, could result in excessive dosage.

· Birth Control: By accelerating estrogen metabolism, Rifampin may interfere with the effectiveness of contraceptive medications. (Since Rifampin is the key drug in modern short-course regimens, changing to an alternative method of birth control such as condom/diaphragm/IUD is preferable to using a different anti-tuberculin drug.)

CASE MANAGEMENT FOR CLASS 3

Class 3 patients receiving TB services through the County TB Program will complete the Agency admission process (see Administrative Manual for Evaluation, Admission and Discharge Policy). This will include patient bill of rights, advance directives and appropriate consents. NOTE: Tell the patient that you will read / review each form with them. Interpretive services will be used when needed and patients will be provided written information in their spoken language.

The TB Control Nurse must ensure that all appropriate action is taken. Ensure that all diagnostic tests have been completed (see Section 7 Suspect TB). Studies of drug sensitivity on initial positive cultures must be done for all patients.

· Medical Care: Ascertain whether the case is already receiving medical care for TB.

· Contact the LHD TB Physician Consultant(s) to make arrangements for all components of the diagnostic evaluation that have not been completed, and for the patient to be examined. If the patient is not already hospitalized, the exam should take place in a facility with a negative pressure room. The patient’s records including history, test for tuberculosis results, bacteriology, and X-ray report(s) and/or film(s) should be available for this appointment.

· If TB care is being given by a private physician, contact with the physician, preferably by telephone, must be made to obtain treatment information. If contact by telephone is not successful, an MD Form Letter (see sample Appendix 4) may be used.

· For cases reported after death, the autopsy report as well as following up with the primary care physician is used to determine whether this individual is a suspect/active case.

· Treatment: Ensure that all suspect and confirmed cases are started on a 4 drug treatment regimen, which typically includes isoniazid, rifampin, ethambutol and pyrazinamide.

NOTE: Baseline testing: Depending on the patient’s age, prescribed drug regimen and risk factors, the patient should receive:

a. Liver function tests

b. Visual acuity testing

c. Testing for color perception

d. Hearing testing (applicable for streptomycin)

See Appendix 8 for Monitoring for Side Effects Log

The duration of therapy depends on the drug(s) used, the drug susceptibility test results, and the patient’s response to therapy. Most patients with previously untreated pulmonary TB can be treated with either a 6-month or a 9-month regimen, although these regimens are referred to as short-course regimens. All regimens of 9 months or less must contain isoniazid and rifampin; all 6-month regimens must contain isoniazid, rifampin, and, initially, pyrazinamide.

See following MMWR Treatment of Tuberculosis, June 20, 2003/Volume 52 No. RR-11 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5211a1.htm

and erratum published for this issue, January 7, 2005/Volume 53/Nos. 51 & 52

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5351a5.htm

Multidrug-Resistant TB (MDR TB) is caused by organisms resistant to the most effective anti-TB drugs, isoniazid and rifampin. These drugs are considered first-line drugs and are used to treat most persons with TB disease. Treatment to be provided in consultation with NYSDOH.

Extensively Drug-Resistant TB (XDR TB) is a relatively rare type of drug-resistant TB. XDR TB is resistant to isoniazid and rifampin, plus any fluoroquinolone and at least one of three injectable second-line drugs (i.e., amikacin, kanamycin, or capreomycin). Because XDR TB is resistant to first-line and second-line drugs, patients are left with treatment options that are more toxic, more expensive, and much less effective. Treatment to be provided in consultation with NYSDOH.

· Arrange for directly observed therapy (DOT) to be initiated. (See Section Nine)

· Initiate Contact Investigation (see Section Ten). If only extrapulmonary TB is diagnosed, patient is not infectious and would not need contact investigation.

· Education: Provide education to all confirmed cases covering these topics:

· TB Disease

· Diagnostic procedures and treatment

· Treatment duration, expectation of cure, importance of compliance

· Medication side effects

· Transmission

· Airborne spread; fomites not involved

· Ventilation; covering coughs

· Contact investigation, including prophylaxis and baseline and follow-up testing (8-10 weeks later) of all contacts

· Infectiousness: The infectious period is closed when ALL of the following criteria are satisfied:

· Effective treatment for greater than or equal to 2 weeks

· Diminished symptoms

· Mycobacteriologic (MTB susceptibility) response (e.g., decrease in grade of sputum smears positivity detected on sputum-smear microscopy).

· HIV Education: Provide HIV education and strongly encourage HIV testing to all suspect/active TB patients.

ONGOING CASE MANAGEMENT:

The TB Control Nurse must ensure that all appropriate action is taken. This includes:

· Bacteriologic examinations as indicated

· A sputum specimen for microscopic examination and culture should be obtained at minimum monthly until three consecutive specimens are negative on culture. More frequent AFB smears may be useful to assess the early response to treatment and to provide an indication of infectiousness.

· Drug sensitivity studies should be done for patients whose cultures are still positive after 3 months of therapy. The Wadsworth State Lab will perform these studies.

· For patients with extrapulmonary TB, the frequency and kinds of evaluations will depend on the site involved. Reference: MMWR June 20, 2003 Treatment of Tuberculosis.

· Continued medical examination as determined by the physician and NYSDOH.

· Monitoring for medication compliance (See Section Nine Directly Observed Therapy)

· Monitoring for medication side effects

· All patients must be continuously monitored for adverse reactions during the period of chemotherapy. Appropriate questions must be asked about each medication and all answers documented in the patient’s chart. Use the Active TB Side Effects Log (see sample Appendix 8).

· For most patients, especially those less than 35 years old, the use of routine laboratory monitoring for sub-clinical drug toxicity is not necessary. If symptoms suggesting an adverse reaction occur, notify TB Consultant/PCP and appropriate laboratory testing should be performed.

· For patients considered at high risk for hepatitis (such as those over 50 years old, or with a history of liver disease) an initial hepatic function test, repeated periodically, is appropriate. Elevated liver

· function tests should be reported to the TB Consultant/PCP and continuing INH, Rifampin, and/or PZA must be carefully evaluated.

· Monthly monitoring of patients on Ethambutol must include evaluation of both visual acuity and color perception by TB Control Nurse or primary care provider.

· Patients on drugs like Streptomycin should be monitored for auditory changes. Refer to Audiologist as indicated.

· The patient chart will be reviewed at least once per month to ensure compliance and the completion of all requirements.

· Recordkeeping: See Recordkeeping Section of this Manual.

· All patients will be followed until officially closed.

DISCHARGE OF ACTIVE TB PATIENT

· Discharge planning will be conducted in collaboration with the PCP/TB Consultant and NYSDOH Regional Representative.

· Transfer to another jurisdiction prior to completion of treatment:

Interjurisdictional TB Notification (IJN) Form is used to notify State and Local Health Departments of TB patients moving from one state to another or from one county to another within New York State.

If a patient is moving to another state or New York City, the IJN Form is faxed to (518) 408-1941 or sent via secure file transfer on the Health Commerce System (HCS) to Michelle.Cummings@health.ny.gov at BTBC Data Unit.

If a TB patient is moving from one county to another within New York State, the IJN Form is

faxed or sent via secure file transfer on the HCS to the Local Health Department of the patient’s

new county of residence with an additional copy faxed to (518) 408-1941or sent via secure file

transfer on the HCS to Michelle.Cummings@health.ny.gov at the BTBC Data Unit.

See New York State Tuberculosis Forms Manual.

· Completion of TB treatment:

· Persons completing a recommended course of treatment for disease should be discharged from the local health department with instructions to call if they develop symptoms that could be caused by

TB. See MMWR Treatment of Tuberculosis, June 20, 2003, Volume 52, No. RR-11 (see Drug Regimen for Tuberculosis Disease Section of MMWR for determining treatment completion).

· A chest x-ray to determine status at the time of therapy completion for TB cases is recommended.

· An Active TB Completion Letter (see Appendix 4 for sample letter) will be sent to patient with a copy sent to the patient’s primary care provider and/or consultant specialist. This letter should be provided in the patient’s spoken language and attention to literacy level. The letter includes a list of TB symptoms, instruction to contact the county health office with any concerns, and clarification that their skin test will remain positive and that they should not receive further TSTs.

· Patients treated for disease who are at high risk of reactivation, for such reasons (i.e., questionable compliance) can be asked to return to MD after 6 months or 1 year for examination, which should include obtaining sputum if possible. The use of x-rays should be minimized unless the patient is symptomatic.

SECTION 9

DIRECTLY OBSERVED THERAPY

MONITORING PATIENT FOR COMPLIANCE

COMPLIANCE

All confirmed TB cases and suspect cases receiving medication therapy will receive directly observed therapy (DOT) by the health department to ensure compliance with the drug regimen except for those in a closely monitored setting (as a nursing homes, proprietary home, jail, school, etc.) where the staff will administer DOT. (See Appendix 9 for sample Parent Authorization for Administration of Medication in School)

LHD personnel administering DOT will abide by standard precautions for infection control including donning a fit-tested, N-95 mask for DOT until the patient is determined non-infectious by three negative sputum smears.

Documentation should be maintained utilizing DOT Client Log (see sample Appendix 8). If DOT is performed in a monitored setting, some form of documentation should be maintained in patient’s chart.

Patients on daily therapy will receive a visit each weekday. The TB Control Nurse/designee will ensure that the patient understands how to take the weekend and/or holiday doses of medication. At the next scheduled home visit, the TB Control Nurse or designee will monitor weekend/holiday compliance closely (example, pill count).

For any patient with a high degree of infectivity and questionable ability to adhere with prescribed medications, weekend DOT may be requested by the physician or Case Manager.

Patient compliance is the key to success of any treatment regime. Efforts must be made to maximize voluntary compliance. Approved incentives may be used to enhance compliance. It is important to follow up suspected noncompliance, including missed appointments, promptly so that lapses in treatment are minimized. If a patient misses a MD appointment, the TB Control Nurse will contact the patient to ascertain reason and reschedule the appointment.

Non-compliant Patients:

Legal action to compel compliance is sometimes required. Generally it is necessary to show that the individual is a danger to the public health, with the most recent sputum culture positive for TB, to obtain a court order. The procedure for this is to consult with DPH and notify your Regional TB Representative for appropriate action. If the patient has active TB, the DPH/Commissioner has the right to pursue appropriate steps for quarantine. See following page for pertinent section of Public Health Law.

VIDEO OBSERVED THERAPY (VOT) OPTION FOR DOT:

Video Observed Therapy is an optional service for real time videoconferencing that may be provided in place of face-to-face DOT. Video Observed Therapy may not be appropriate for all patients. Persons with drug resistant TB or not meeting all of the following criteria for VOT require collaboration with the PCP and State and Local Health Departments.

Video observed therapy may replace face-to-face DOT for periods of time if certain criteria are met, as below:

Patients that are selected for VOT must:

· Be attending their scheduled health care provider appointment

· Be tolerating therapy well

· Be showing evidence of clinical improvement on medication therapy

· Be motivated to take/comply with their face-to-face DOT for at least two months prior to initiating VOT

· Be free of adverse effects

· Be at low risk of adverse events (no liver disease or risk, no drug allergies, etc.)

· Have a suitable location for the use of the video equipment to maintain confidentiality

· Be willing to sign and comply with a contract that defines the conditions for VOT (see sample contract in Appendix 10).

Personnel providing VOT must:

· Receive training on VOT and confidentiality prior to administering VOT

· Be educated regarding required VOT documentation

· Have backup personnel trained to administer VOT in their absence

· Establish an alternative plan in the event of VOT interruption/failure including several methods for contacting the patient

VOT Procedure:

· Assess for patient eligibility for VOT

· Obtain signed contract

· Ensure that the necessary equipment is available (laptop/tablet, telephone and a high definition, encrypted, HIPAA compliant video conferencing system).

NOTE: If a high definition, encrypted, HIPAA compliant video conferencing system is not available the patient, in collaboration with the PCP and State and Local Health Departments, may waive their right to confidential VOT.

· Ensure that the necessary WIFI is available at the patient’s location.

· Arrange for testing of the VOT equipment in the patient’s home, prior to implementation.

· Educate patient regarding:

· agreed upon time for VOT

· the importance of a private location

· what to do in the event of adverse effects

· Implement VOT assuring that you can visualize the medication(s) prior to ingestion and verifying that the medication(s) were swallowed

· Assess for medication side effects

Causes for Discontinuation of VOT:

· Two consecutive missed VOT sessions without justification

· TB control staff deemed the patient unreliable and non-compliant

Documentation:

Personnel will utilize the DOT Client Log (see Appendix 8) denoting those sessions that were performed via VOT.

Public Health Law

TITLE II – CONTROL OF PATIENTS

§ 2120. Communicable diseases: control of dangerous and careless patients; commitment.

1. Whenever a complaint is made by a physician to a health officer that any person is afflicted with a communicable disease or a carrier of typhoid fever, tuberculosis, diphtheria or other communicable disease and is unable or unwilling to conduct himself and live in such a manner as not to expose members of his family, household or other persons with whom he may be associated and in danger of infection, the health officer shall forthwith investigate the circumstances alleged.

2. If the health officer finds after investigation that a person so afflicted is a menace to others, he shall make and file a complaint against such person with a magistrate, and on such complaint the said person shall be brought before such magistrate.

3. The magistrate after due notice and a hearing, if satisfied that the complaint of the health officer is well founded and that the afflicted person is a source of danger to others, may commit the said person to any hospital or institution established for the care of persons suffering from any such communicable disease or maintaining a room, ward or wards for such persons.

4. In making such commitment the magistrate shall make such order for payment for the care and maintenance of the person committed as he may deem proper.

5. A person who is committed pursuant to the provisions of this section shall be deemed to be committed until discharged in the manner authorized by section two thousand one hundred twenty three of this chapter.

(L. 1953. c. 879, § 1.)

Historical and Statutory Notes

Derivation. Public Health Law of § 15: and repealed by §5002 of this section.

1409. § 326-a. added L.1913, c. 539. chapter.

Cross Reference

Due notice and hearing requirement, see McKinney’s Const. Art. 1. § 6.

Magistrate defined, see General Construction Law. § 28-b.

New York Codes, Rules and Regulations

Carriers and control carriers of disease, see 10 NYCRR 2.40 et seq.

Isolation, quarantine and restriction, see 10 NYCRR 2.25 et seq.

Library References

American Digest System

Contagious and infectious diseases: precautions in general, see Health and Environment 23.

Contagious and infectious diseases: quarantine, see Health and Environment 24.

Hospital inmates, see Hospitals 5.

Encyclopedia

Hospital patients in general, see C.J.S. Hospitals § 13.

SECTION 10

CONTACT INVESTIGATION

DESCRIPTION

Contact Investigation: Is a process that involves identifying, evaluating and, if appropriate, placing persons exposed to a TB patient on treatment for either LTBI or TB disease. These individuals are managed until completion of therapy.

DEFINITIONS

Index case: The individual with confirmed or suspected TB disease reported to the health department. (Note: The county in which the index case resides has primary responsibility for contact investigation. If contacts reside outside of the investigating county, the investigating county will work collaboratively with the all other affected LHDs. Each county is responsible for investigating transmission within its borders.)

Source Case: During the investigation of an index case, a source case may be identified. A source case is defined as the person with confirmed infectious pulmonary or laryngeal TB who is responsible for transmitting M.tb to the index case.

Close contact: A person who has had prolonged, intense or frequent contact (on average 8 or more hours per week) with the active TB patient during the infectious period.

Other-Than-Close Contacts: a person who has had less prolonged, intense or frequent contact with the active TB patient during the infectious period (less than 8 hours a week).

High Priority Contacts: Contacts who are to be evaluated without delay including those most likely to be infected and those with risk factors for progression to disease once infected (this applies to close and other than close contacts). High risk contacts that must be screened without delay:

1. HIV or immunosuppressive medical condition or treatment

2. Medical risk

3. Exposure during bronchoscopy, sputum induction or autopsy

4. Children, less than 5 years of age

Infectious Period: The start of the infectious period is three months prior to first finding consistent with TB if there are no respiratory symptoms (cough) OR three months before the onset of cough, whichever is longer. The decision to extend the infectious period is based on medical and/or epidemiological consultation. Recalculation is based upon the results of the contact evaluations and changes in clinical condition of the TB patient.

Window Treatment: Treatment for LTBI administered between the time of a non-significant baseline TST and the follow-up TST 8-10 weeks later. Children less than 5 years old and adults who are immunocompromised should receive treatment for LTBI even if the baseline TST is

negative. All persons considered for Window Treatment should be evaluated for TB disease by chest radiography and symptom review prior to the start of LTBI treatment. Window treatment can be discontinued if:

· TB is ruled out in the suspect index case

 OR, if all of the following conditions are met:

· The infant is at least 6 months of age

· The second (follow-up) TST is also negative

The second (follow-up) TST was performed at least 8 weeks after the individual was last exposed to an adult with infectious TB disease.

Concentric Circle: A method of classifying and screening contacts in order of intensity of exposure and risk of being infected. This interview process is completed in an orderly fashion and defines the limits of the investigation.

Initiating a Contact Investigation (CI)

MMWR 12/16/2005/ vol. 54/No. RR-15 page 5

ASSESSMENT of TRANSMISSION

The first concentric circle includes testing of close contacts. If transmission is probable, testing is expanded to include other-than–close contacts. If close contacts test positive or convert at the baseline test or a contact is identified as suspect or active TB, the investigation should be expanded to include other-than-close contacts.

Close contacts exposed to patients with high degree of infectiousness are likely to be infected based upon several factors

1. Laryngeal or pulmonary TB

2. AFB sputum smear positive

3. Cavitary disease on CXR

4. Cough

5. Contacts in congregate settings * (ie: prisons, shelters, nursing homes, crowded rooms, areas poorly ventilated, areas without air cleaning systems)

6. Contacts who have had prolonged exposure longer than eight hours/week during infectious period with close contact.

Note: It is important on examination to remember that once transmission has occurred, it will require 2-8 weeks post-exposure for the newly infected person to develop an immune response. This is the basis for baseline and follow-up. * Any investigation which shows there is the possibility of transmission to a large group of people, as in a school or residential facility, must be reported immediately to NYSDOH regional office.

Characteristics of the index patient and behaviors associated with increased risk for TB transmission

Characteristic____________________________________________Behavior______________

Pulmonary, laryngeal, or pleural TB Frequent cough

AFB positive sputum smears Sneezing

Cavitation on chest radiograph Singing

Adolescent or adult patient Close social network

No or ineffective treatment of TB disease

______________________________________________________________________________

MMWR 12/16/05 Vol. 54/No. RR-15 pg 4

Investigating the Index Patient

Within 72 hours of suspect/active report, interview the patient to develop list of contacts using the Index Case Interview for Contacts Form (Appendix 11) and the TB Contact Follow-up Log Sheet (Appendix 11). The contact investigation will be managed in accordance with CDC guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis (http://www.cdc.gov/tb/publications/guidelines/ContactInvestigations.htm). Information in the medical record can be disclosed to public health authorities under exemptions in the Privacy rule of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, revised 2003. https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/disclosures-public-health-activities/index.html

Information includes:

· Disease characteristics

· Onset time of illness

· Names of contacts

· Exposure locations

· Current medical factors (e.g., initiation of effective treatment and drug susceptibility results)

Pre-Interview:

1. Review current medical record.

2. Contact with physician who reported the case and/or infection control personnel if hospitalized.

3. NYSDOH Regional Representative(s) should be consulted throughout the contact investigation process. If several counties and/or institutions are involved in the contact investigation, they should collaborate to decide whether to expand a search.

4. Patient’s name (maiden/alias) should be matched to prior TB registries and to the surveillance database to determine if the patient was previously listed to determine the strain if possible.

Factors relevant for investigation:

· History of previous exposure to TB

· History of previous TB disease and treatment

· Anatomical sites of TB disease

· Symptoms of illness

· Date of onset

· Chest radiograph results

· TST or IGRA results

· Other diagnostic imaging studies

· Specimens that were sent for analysis noting the medication regimen

· Current bacteriological results

· Anti-TB chemotherapy regimen (dates, med doses, and treatment plan)

· HIV testing results

· patient’s concurrent medical conditions (e.g., recent dialysis )

· other diagnoses (e.g., substance abuse, mental illness, dementia) which may affect the interview

· demographic information

Residence Telephone numbers

Employment Next- of- kin

First language Emergency connections

Date of birth Given name, street names, aliases, maiden name

Infectious Period

Identification of the period of time where the infectious case is potentially exposing others and sets the timeframe for testing contacts.

MMWR 12/16/05/VOL. 54//No.RR-15 page 7

(Note: In certain circumstances an earlier start should be used (e.g., a patient may have been aware of prolonged illness for more than a year).

INVESTIGATION PLAN

The plan starts with information gathered in the interviews and site visits as well as development of a registry of the contacts and their assigned priorities. (See Appendix 11 for Prioritization of contacts).

Identifying Contacts-Gathering All Information

“WHERE-WHOM-WHAT-WHEN”

To help identify contacts, interviewers should collect and confirm information regarding:

1. Places WHERE they spent time during infectious period

· Residence, work, school, leisure, religious, or recreation sites, homeless shelters or jails.

· After obtaining list of places ask the amount of time spent at each: environmental characteristics (# rooms, room size/square footage, crowding, ventilation, windows open or closed)

· School: name of school, address, phone number, grade in school, hours per day/week, transportation type to and from school, length of commute, extra-curricular activities

· Workplace: Employers name, address, phone contact, full or part-time, hours worked per day/week, occupation/type of work, indoor work space, if unemployed source income.

2. Persons with WHOM they spent time during infectious period

· Wife, husband, partner, children, step children, household members, other family members, friends, roommates, cellmates, coworkers. Ask for names and aliases of contacts, do contacts have TB symptoms, weakened immune systems or are children younger than 5 years old.

3. Participation in activities and events (WHAT & WHEN)

· Social/recreational places of activities, home parties, hangouts, bars, clubs, team sports, community centers, bands, choir, places of worship and the hours per day/week and means of transportation.

4. Information collected about each contact includes:

· Name

· Age

· Relationship

· Address and Phone Number

· Exposure Time (First and last time the case saw the contact & frequency of interaction)

· Setting Size (Size of a bedroom, car/van, house?)

(See Appendix 11 for Sample Contact Intake Form)

Priorities for Contact Investigation

Assignment of priority contact evaluation is based on both the characteristics of the known or suspected TB index patient and the characteristics of the contact (Bureau of Tuberculosis Control). Contacts will be classified as high, medium or low priority. (See Appendix 11 for Prioritization of Contacts)

Close Contacts Prioritized as High and Medium are:

1. Questioned about TB symptoms

2. Given an initial Tuberculin Skin Test (TST) or IGRA [see Section 3] except if a documented, positive TST is available. NOTE: Consultation with the NYSDOH and TB Physician will determine next steps for contacts with documented, previous positive TST.

· If the initial TST is greater than or equal to 5mm, contact should receive CXR and be evaluated for treatment for LTBI.

· If the initial TST is less than 5mm:

· Contact is educated regarding the need to return in 8-10 weeks post exposure, symptoms to watch for, what to report immediately, and the availability of prophylaxis and treatment for LTBI if indicated.

· Considered for Window Treatment if classified as high priority and/or the case is highly infectious (e,g., AFB+ sputum smears, cavitary CXR, exhibited TB symptoms for an extended time).

· Give a follow-up TST in 8-10 weeks. NOTE: If the contact remains in the same household of a suspect or active TB case, follow-up testing should be delayed beyond the 8-10 weeks. In this instance, follow-up testing will occur only after the suspect case is no longer considered infectious (see Section 8 of this manual).

NOTE: If there was transmission to close contacts, the “other-than-close contacts” will be contacted and evaluated until there is no transmission or risk of transmission.

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SECTION 11

REFUGEES, IMMIGRANTS AND SEASONAL WORKERS

· TB notification forms received from the Immigration Services must be followed up immediately.

· In the case of non-English speaking patients, a translator shall be used as indicated (see Interpretative Services Policy in S2AY Network Administrative Policies Manual).

· The standard procedure for refugee screening is according to NYSDOH TB Manual.

Refugee/Immigrant Follow-up Procedure

Refugee Health Assessment Form:

· Each refugee should have a physical exam unless refugee is already under medical care.

· The Local Health Department may do the screening for TB.

· Physician may bill Medicaid for reimbursement if applicable.

· Completed form is to be returned to TB Control Nurse. (See NYS Tuberculosis Forms Manual)

· TB Control Nurse forwards white copy of form with a standard voucher to NYS DOH at address indicated in TB Forms Manual.

Report on Alien with Tuberculosis not considered active

· Attempts should be made to locate this refugee as he/she is at high risk for reactivation of disease.

· TB physician should prescribe INH treatment (one year of treatment is recommended) for one year if refugee has not received chemotherapy or chemoprophylaxis.

· When form is completed or if unable to locate, forward entire copy to NYS DOH at address indicated in TB Forms Manual. (See NYS Tuberculosis Forms Manual, Report of Alien With Tuberculosis Section)

Seasonal Workers follow-up Procedure

When a TST positive, seasonal worker is identified and is relocated to an unknown location, contact the TB Regional Representative and:

TB Net & Migrant Clinician 512-327-2017 or Website:  www.migrantclinician.org to arrange for further treatment in that Country.

SECTION 12

REPORTING, PROGRAM AND FINANCIAL MANAGEMENT

REPORTING OF ACTIVE/SUSPECT TB CASES

· Providers should report Confirmed and Suspect Cases to the county within 24 hours of identification, by telephone. The County must record the information needed for DOH 389/DC-103 (See NYS Tuberculosis Forms Manual).

· Contact Regional Office TB Representative with Confirmed or Suspect Case TB information.

Angel Cardona

Western Region TB Coordinator

335 E Main St.

Rochester, NY 14604

Phone 585-423-8059 (office)

Fax 585-423-8108

Email angel.cardona@health.ny.gov

· The County must complete the data submission page on the HCS, reporting it as a confirmed or suspect case within 72 hours. You may wish to use form DOH 389 to gather the required information for reporting electronically on the HCS. Print and retain a copy for the patient record.

Enter data on the HCS using the Communicable Disease Electronic Surveillance System (CDESS). The CDESS offers a help desk for guiding user through the reporting process. TB Control Nurse will maintain an active HCS account with TB reporting access.

· The TB Control Nurse will initiate the TB Supplement on CDESS within two weeks and update as information is reported.

TB Ruled Out – When culture results or other evidence have resulted in the determination that the suspect case is not a case of active tuberculosis, the decision to rescind the suspect diagnosis will be made by the physician providing TB follow up. The reason for ruling out TB must be reported to New York State utilizing the TB Supplement Form on CDESS and will be noted on TB Suspect/Active Case Log (see sample Appendix 7). Print and retain a copy for the patient record.

Diagnosed TB Case (Class 3, Confirmed) – Determine whether the case has been reported as a suspect case or not. The TB Supplemental Form on CDESS will be updated accordingly.

PROGRAM MANAGEMENT FOR LATENT AND SUSPECT CASES

· Complete and submit the following TB Targeted Testing (TBTT) Forms via the HCS: (See HCS for forms and further instructions):

· Individual TB Worksheet: TB Control Nurse must complete a worksheet on any individual identified to the LHD for TB consultation/therapy. At minimum annually, the worksheet will be submitted via the TBTT section of CDESS.

· TB Testing Worksheet: The TB Control Nurse must complete a Testing Worksheet at minimum annually. This worksheet will identify the individuals evaluated by the LHD and include the following:

· Number of TSTs administered and evaluated by the local health unit;

· Number of TSTs administered by the local health unit, evaluated by another provider and the result reported to the local health unit;

· All individuals referred to the local health unit for management as a result of a positive TST.

· TB Contacts: The TB Control Nurse will complete the TB contact module in CDESS for each contact associated with an active case.

FINANCIAL MANAGEMENT

· Information on each patient’s medical insurance will be obtained by TB Control Nurse. The county is considered secondary payor if the patient has insurance, either private, Medicaid or Medicare. Uninsured individuals should be referred to a Facilitated Enroller serving to County for assistance with applying for public health insurance.

· The hospital will complete applicable sections of DOH 1565 Medical Insurance Determination Form and submit to the TB Control Nurse. The LHD must complete applicable sections and submit to NYSDOH when the hospital is seeking reimbursement from County or State (see NYS Tuberculosis Forms Manual). County pays for hospitalization if patient is a county resident and has no insurance. An uninsured person who is not a resident of the county would qualify for state funds for hospitalization.

· The County/private pharmacy will bill the Local Health Department if patient is not covered by medical insurance.

· The Local Health Department may apply for reimbursement for DOT on TB suspects/patients on Medicaid or Medicaid Managed Care, if the county has applied to be a Medicaid or Medicaid Managed Care DOT provider. (If not, discuss with your NYS TB Representative) Complete initial enrollment form, and maintain form which logs DOT visits (see instructions for Medicaid or Medicaid Managed Care DOT program). The LHD’s Billing Office will handle the voucher procedures for DOT reimbursement.

· See Appendix 12 for NYSDOH Guidelines for the Provision of TB Directly Observed Therapy.

SECTION 13

REFERENCES

· Centers for Disease Control and Prevention. (2013, 6th ed). Core curriculum on tuberculosis: What the clinician should know. Retrieved June 30, 2014, from http://www.cdc.gov/tb/education/corecurr/default.htm

· Centers for Disease Control and Prevention: Tuberculosis: http://www.cdc.gov/tb/

· Curry TB Center. Drug-Resistant Tuberculosis: A Survival Guide for Clinicians

· Latent TB Infection: A Guide for Primary Health Care Providers 2013: http://www.cdc/tb/publications/LTBI/default.htm

· MMWR on the following topics go to www.cdc.gov/mmwr

· Controlling Tuberculosis in the United States

· Guidelines of the Investigation of Contacts of Persons with Infectious Tuberculosis & Guidelines for Using the Quantiferon-TB Gold Test for Detecting Mycobacterium tuberculosis Infection

· Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health Care Settings

· Prevention & Control of Tuberculosis in Correctional and Detention Facilities: Recommendations from CDC

· Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection 2000:49 (no. RR-6)

· Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection – United States, 2010, June 25, 2010 Vol. 59 No. RR-5

· Treatment of Tuberculosis, June 20, 2003 Vol. 52 No. RR-11

· Most recent Tuberculosis Control Program Manual; New York State Department of Health Bureau of Tuberculosis Control

42

Put on LetterheadTuberculin Skin Test Consent and Questionnaire

Name: _______________________________________________ Date: __________________

Address: _________________________________________ City: ____________________ Zip: _______

Phone # ___________________________DOB: ____________________ Age: ________ Male / Female

Physician ______________________________________Reason for testing: __________________________

Office use only (Comments)

Screening Questions:

1. Have you ever had Tuberculosis disease?Yes No

2. Have you ever had a positive TB skin test or blood test?Yes No

3. Is any family member currently being treated for TB?Yes No

4. Have you had a TB test in the past year?Yes No

5. Are you taking any medications containing steroids?Yes No

6. Do you have an acute infection at the present time?Yes No

7. Have you ever been in contact with any person

diagnosed as having TB disease?Yes No

8. Have you had a live virus vaccine within the past month?Yes No

(measles, mumps, rubella, chicken pox, oral polio, smallpox,

yellow fever, LAIV, shingles).

9. Do you have a history of fainting?Yes No

I have had the opportunity to review the Agency’s Notice of Privacy Practices that describes my rights and the Agency’s duties with respect to my protected health information. The Agency’s Notice is also displayed in the clinic waiting room. The Agency reserves the right to change the privacy practices in the Notice. I may obtain a revised Notice by calling the Agency at . A revised notice will either be sent in the mail or delivered during a regularly scheduled home visit. The Patient Bill of Rights has been provided to me.

Signature of person to receive TST screening or person authorized to make the request (parent or guardian)

X___________________________________________________ Date: _________________

Date Given: ___________ Time Placed: __________ By (Name): __________________________________

Site: _________________ Mfg: __________________ Lot #: ___________________ Exp. Date __________

Date Read: ____________ Time Read: _____________ By (Print Name) _____________________________

Reaction: (Circle One) 0mm / Other (describe in mm)____________________________________________

Appendix 1