Tuberculosis Control Plan for the University Of Delaware Student Health Service

Outline

1. Introduction

2. Risk Assessment

3. Staff Training

4. Medical Surveillance

5. HCW Counseling Screening and Evaluation

6. Tuberculosis Contact Investigation

7. Forms, Supplements, and Attachments

8. Glossary of Terms

1. Introduction

The purpose of this control plan is to reduce the risk of transmission of tuberculosis (TB) to Student Health Service (SHS) employees hereafter referred to in this document as Health Care Workers (HCW's) as well as patients, visitors and other persons in this facility. It is also intended to comply with State of Delaware and Center for Disease Control (CDC) and other federal guidelines for preventing the transmission of Mycobacterium tuberculosis in this health care facility.

2. Risk Assessment

Transmission of Mycobacterium is a recognized risk in health care facilities. The risk assessment for the SHS was determined using the protocol for conducting tuberculosis (TB) risk assessments in a health care facility. A review of the Newark Community TB Profile was procured from the Division of Public Health of the State of Delaware and a review of the number of TB patients examined as inpatient or outpatients at the SHS was conducted by the Director of the SHS, E.F. Joseph Siebold, D.O., F.A.A.P.

A review of both these numbers clearly show that there have been no cases of active TB that fit the profile of University of Delaware students in the community nor were there any cases of active TB treated at the SHS (Please remember that the few cases of positive TB (Mantoux) skin test (converters) that have been referred to the Division of Public Health TB Chest Clinics) by the SHS were not diagnosed with active tuberculosis. The cases reported in the zip codes for the University of Delaware were not identified as students.

Based on this initial (July 1995) risk assessment the University of Delaware Student Health Service qualifies as a very low risk health care facility.

A TB testing program for all SHS staff will be conducted beginning in August and continued through the fall of 1995. The results of that program will be used to re-evaluate the risk assessment category of the SHS. If as a result of this testing program there is no change in the status of SHS as a very low risk health care facility then annual testing and risk assessment will begin in the fall of 1996.

In addition, the SHS will conduct an additional risk assessment survey at any time if there is administrative notification of active TB in a University of Delaware student (patient) or SHS staff. In keeping with its categorization as a very low risk facility the SHS does not treat patients with active TB. Any patients/staff of the SHS in whom the diagnosis of TB is confirmed or reasonably suspected will be immediately referred for definitive evaluation and care to the Division of Public Health or an infectious disease specialist.

3. Staff Training

All HCS’s (SHS employees) will receive education and training regarding TB

Training will begin this fall (95) and be repeated annually thereafter. All newly hired employees will receive TB training.

The training will include the following elements:

  • The basic concepts of M. tuberculosis transmission, pathogenesis, and diagnosis, including information concerning the difference between latent TB infection and active TB disease, the signs and symptoms of TB and the possibility of re-infection.

  • The potential for occupational exposure to persons who have infectious TB in the health-care facility, including information concerning the prevalence of TB in the community and facility, the ability of the facility to properly isolate patients who have active TB and situations with increased risk for exposure to M. tuberculosis.

  • The principles and practices of infection control that reduce the risk for transmission of M. tuberculosis, including information concerning the hierarchy of TB infection control measures and the written policies and procedures of the facility. Site specific control measures should be provided to HCSs working in areas that require control measures in addition to those of the basis TB infection control program.

  • The purpose of PPD skin testing, the significance of a positive PPD test result, and the importance of participating in the skin test program.

  • The principles of preventive therapy for latent TB infection. These principles include the indications, use, effectiveness, and the potential adverse effects of the drugs.

  • The HCW'’s responsibility to seek prompt medical evaluation if a PPD test conversion occurs or if symptoms develop that could be caused by TB Medical evaluation will enable HCS’s who have TB to receive appropriate therapy and will help to prevent transmission of M. tuberculosis to patients and other HCWs.

  • The principles of drug therapy for active TB.

  • The importance of notifying the facility if the HCW is diagnosed with active TB so that contact investigation procedures can be initiated.

  • The responsibilities of the facility to maintain the confidentiality of the HCW while ensuring that the HCW who has TB receives appropriate therapy and is noninfectious before returning to duty.

  • The higher risks associated with TB infection in persons who have HIV infection or other causes of severely impaired cell mediated immunity, including

      a) the more frequent and rapid development of clinical TB after infection with M. tuberculosis,

      b) the differences in the clinical presentation of disease, and

      c) the high mortality rate associated with MDR-TB in such persons.
  • The potential development of cutaneous energy as immune function (as measured by CD4+T-lymphocyte counts) declines.

  • Information regarding the efficacy and safety of BCG vaccination and the principles of PPD screening among BCG recipients.

  • The facility's policy on voluntary work reassignment options for immunocompromised HCW's.

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    4. Medical Surveillance for TB

    In keeping with its categorization as a very low risk facility the SHS does not treat or admit active TB patients to its inpatient or outpatient areas. In addition, HCW’s with active TB or whom are reasonably suspected of having active TB will not be allowed to work at the SHS until that HCW is non-infectious. Such proof will be provided to the Director of the SHS in consultation with the Division of Public Health.

    Any patient/staff in whom the diagnosis of TB is confirmed or reasonably suspected will be immediately referred for definitive evaluation and care. Usually, this referral is to the Division of Public Health or to an infectious disease specialist.

    The SHS will remain vigilant in evaluating patients and SHS HCW's for tuberculosis especially if they are in a risk category. Groups of persons known to have a higher prevalence of TB infection include contacts of persons who have active TB foreign-born persons from areas of the world with a high prevalence of TB (e.g., Asia, Africa, the Caribbean, and Latin America), medically under served populations (e.g., some African-Americans, Hispanics, Asians and Pacific Islanders, American Indians, and Alaskan Natives), homeless persons, current or former correctional facility inmates, alcoholics, injecting-drug users and the elderly. Groups with a higher risk for progression from latent TB infection to active disease include persons who have been infected recently (i.e., within the previous 2 years), children <4 years of age, persons with fibrotic lesions on chest radiographs and persons with certain medical conditions (e.g., human immunodeficiency virus (HIV) infection, silicosis, gastrectomy or jejuno-ileal bypass, being >10% below ideal body weight, chronic renal failure with renal dialysis, diabetes mellitus, immunosuppression resulting from receipt of high-dose corticosteroid or other immunosuppressive therapy and some malignancies) have a known exposure and have a history or physical findings of persistent cough (e.g., a cough lasting for >3 weeks) or other signs or symptoms compatible with active TB (e.g., bloody sputum, night sweats, weight loss, anorexia, or fever). However, the index of suspicion for TB will vary in different geographic areas and will depend on the prevalence of TB and other characteristics of the population served by the facility. The index of suspicion for TB should be very high in geographic areas or among groups of patients in which the prevalence of TB is high. Appropriate diagnostic measures should be conducted and TB precautions implemented for patients in whom active TB is suspected.

    By screening, prompt identification and quick referral, the SHS will fulfill its obligation to staff and students to help prevent the transmission of TB in this health-care facility.

    At a minimum, while arranging for immediate patient (student) referral for definitive diagnosis and care , the SHS will provide the following:

    1. Place the patient in a separate area apart from other patients and not in open waiting area (e.g. single inpatient room). With respiratory isolation sign at entrance. (See Special Respiratory Isolation attachment.)

    2. Give the patient a surgical mask to wear and instruct the patient to keep it on.

    3. Give the patient facial tissues and instruct the patient to cover their mouth and nose with the tissue when coughing or sneezing.

    4. Provide a hazardous waste (red bag) for disposal of these facial tissues.

    5. HCW Counseling, Screening and Evaluation

    HCW counseling, screening and evaluation is designed to protect employees and patients. All information on counseling, screening and evaluation is confidential but PPD skin test results will be recorded in the employees' files and on the TB Skin Test Result Master File (see attached Tuberculin Test Register - 1995). The information on the register will be used for risk assessments and actions to reduce the risk of transmission of TB to SHS employees.

    A. Counseling HCW's regarding TB

    This choice should be a personal decision for HCW's after they have been informed of the risks to their health.

  • The Student Health Service will make reasonable accommodations (e.g., alternative job assignments) for employees who have a health condition that compromises cell mediated immunity and who work in settings where they may be exposed to M.tuberculosis. HCW's who are known to be immunocompromised should be referred to employee health professionals who can individually counsel the employees regarding their risk for TB. Upon the request of the immunocompromised HCW, the Student Health Service will offer, but not compel, a work setting in which the HCW would have the lowest possible risk for occupational exposure to M.tuberculosis. Evaluation of these situations should also include consideration of the provisions of the Americans With Disabilities Act of 1990 and other applicable federal, state, and local laws.

  • All HCW's will be informed that immunosuppressed HCW's should have appropriate follow-up and screening for infectious diseases, including TB provided by their medical practitioner. HCW's who are known to be HIV infected or otherwise severely immmunosuppressed should be tested for cutaneous energy at the time of PPD testing. Consideration should be given to retesting, at least every 6 months, those immunocompromised HCW's who are potentially exposed to M.tuberculosis because of the high risk for rapid progression to active TB if they become infected.

    B. Screening HCW's for active TB

    C. Screening of Student Health Service HCW's for Latent TB Infections

  • In the Fall of 1995, all Student Health Service employees will be involved in a TB (Mantoux PPD Skin Test) program. This TB skin test will be provided yearly (each Fall) for all present employees and at the time of hiring for all new employees or anytime if there is a TB exposure and the risk assessment changes for the Student Health Service.

  • Student Health Service employees with a documented history of a positive PPD test, adequate treatment of disease or adequate preventive therapy for infection will be exempt from further PPD testing unless they develop signs and symptoms suggestive of TB

  • For Student Health Service employees who have not had a documented negative PPD test result during the preceding twelve months, the baseline (Fall 95) PPD testing will employ the two step method, this will detect boosting phenomena that might later be misinterpreted as a skin test conversion. This means that employees will have a PPD test and if negative, a second PPD test one to three weeks after the first test. To understand the booster phenomena employees (HCW's) must be aware of what is a positive PPD or hypersensitivity to tuberculin protein.

  • A person develops hypersensitivity to tuberculin protein after being infected with M.tuberculosis or from receiving the BCG vaccine. This hypersensitivity does not develop from simple tuberculin skin testing. The hypersensitivity to PPD material, as measured by the amount of induration, may gradually decrease over the years in some persons. These persons may have no reaction when administered a PPD skin test many years after their initial infection or BCG vaccination. However, this "recent" PPD skin test could stimulate the hypersensitivity reaction, and then when the test is repeated the following year it may show significant induration, often resulting in it being misread as a "positive" result. This effect is called the "boosted phenomenon" and may be common in persons over age 55, but can occur at any age.

  • The boosted phenomenon is a concern in a serial or periodic screening program because it may create the false impression of a new PPD conversicn or a new infection. In this situation, the first PPD skin test produces little or no induration, but the boosted reaction, which occurs in response to a PPD skin test a year or more later, is read as a "positive" skin test response. This "positive" response is then attributed to a tuberculosis infection newly acquired in the year between the first and the subsequent test. Whereas, in reality, the "positive" result is simply the boosted response.

  • The Two-step Testing Procedure can reduce the likelihood of interpreting a boosted response as evidence of a new infection. If the reaction to a first PPD skin test is classified as not significant, apply a second test a week later. Use the results of the second test as the baseline for subsequent testing. If the reaction to the second test is significant, manage the person as infected. If the reaction to the second test is not significant, manage the person as not infected. Again, this method is most useful in persons over 55 years of age but can occur at any age. It should be considered when dealing with persons who lack documentation of prior TB testing results.

  • All PPD tests should be administered, read, and interpreted in accordance with current CDC guidelines. At the time their test results are read, HCW's should be informed about the interpretation of both positive and negative PPD test results. This information should indicate that the interpretation of an induration that is 5-9 mm in diameter depends on the HCW's immune status and history of exposure to persons who have infectious. TB Specifically, HCW's who have indurations of 5-9 mm in diameter should be advised that such results may be considered positive for HCW's who are contacts of persons with infectious TB or who have HIV infection or other causes of severe immunosuppression (e.g., immunosuppressive therapy for organ transplantation).

  • In any area of the Student Health Service where transmission of M.tuberculosis is known to have occurred, a problem evaluation should be conducted, and the frequency of skin testing should be determined according to the applicable risk category. PPD test results should be recorded confidentially in the individual HCW's employee health record and in an aggregate database of all HCW PPD test results. The database can be analyzed periodically to estimate the risk for acquiring new infection in specific areas or occupational groups in the facility.

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    D. PPD Administration Procedure:

  • The approved tuberculin skin test material for the routine Mantoux test is the premixed Tween-80-stabilized intermediate strength PPD (5TU equivalent). The low strength PPD (1 TU equivalent) is used for low strength tuberculin skin tests, when indicated in special situations. Tine or Monovac tests are not to be used for the purposes of this protocol.

    • a) Prepare a tuberculin syringe with a single dose of 0.1 ml of intermediate strength (5 TU) PPD. Fill the syringe immediately before use because the solution can be absorbed into the plastic of the syringe.

    b) Make an intradermal injection of 0.1 ml of intermediate strength (5 TU) PPD. Fill the syringe immediately before use because the solution can be absorbed into the plastic of the syringe.

    c) Enter the date administered, site that the test was applied (e.g. left forearm), type of tuberculin test used and strength (e.g. PPD 5 TU), in the employee's chart.

    E. PPD Interpretation Procedure:

  • Examine the tuberculin skin test site 48 to 72 hours after administration. The test must be read by a health care worker who is both trained and experienced in reading and interpreting tuberculin skin tests.

  • When reading, keep the tested forearm relaxed and slightly flexed at the elbow. Find the margin of the induration by drawing the index or middle finger lightly across the reaction. Use a flexible ruler to measure the induration (swelling) in millimeters at its widest transverse diameter. If the measurement falls between two millimeter divisions of the scale, record the lower value. Redness without induration has no significance. If there is a complete absence of induration, record "zero mm", never record the term "negative" or "positive". Otherwise, record the actual measurement of the reaction in millimeters (e.g. "3mm"). If it is difficult to locate the margins of the reaction, look at the reaction in a cross light while lightly drawing a finger over the reaction.

  • Follow these steps in cases where the patient does not return at the appropriate time for PPD interpretation:

    • a) If the person returns more than 72 hours after application of the PPD and the induration is between zero mm and 14 mm, make an entry in the PPD result area of their medical record of "not read". Then apply another PPD test to the opposite arm, making the appropriate notations in their chart. Have them return again in 48-72 hours for PPD reading.

    b) If the person returns more than 72 hours, but before or on the 10th day after PPD application and the induration is 15 mm or greater, the reaction is to be considered significant. Enter the induration and time interval since test application in the employee's chart. Manage the person as a tuberculin reactor per this protocol.

    c) If the person returns more than 10 days after PPD application, make an entry in the chart as "not read" regardless of the size of any induration. Then administer a PPD test on the opposite arm and make the appropriate notations in the employee's chart. Have them return in 48-72 hours for interpretation.

    d) If the person never returns for PPD interpretation, record "not read" in their chart.

    F. Summary of Interpretation of PPD Skin Tests*:

    a) A reaction of greater than or equal to 5 mm is classified as positive in:

  • Persons with HIV infection or risk factors for HIV infection with unknown HIV status.

  • Persons who have had recent close contact of persons with active TB. "Close contact" implies household contact or unprotected occupational exposure similar in intensity and duration to household contact.

  • Persons who have abnormal chest radiographs consistent with old healed TB.

    • b) A reaction of greater than or equal to 10 mm is classified as positive in all persons who do not meet any of the criteria above but who have other risk factors for TB including:

    High-Risk Groups:

  • Intravenous drug users known to be HIV seronegative.

  • Persons with other medical conditions that have been reported to increase the risk of progressing from latent TB infection to active TB including silicosis, gastrectomy, jejuno-ileal bypass surgery, being 10% or more below ideal body weight, chronic renal failure, diabetes mellitus, high dose corticosteroid and other immunosuppressive therapy, leukemia, lymphoma, and other malignancies.

    •

    High Prevalence Groups:

  • Foreign-born persons from high prevalence countries in Asia, Africa, and Latin America.

  • Persons from medically under served low income populations.

  • Residents of long term care facilities (e.g., correctional institutions and nursing homes).
  • Persons from high risk populations in their communities, as determined by local public health authorities.
    •

    c) Induration of greater than or equal to 15 mm is classified as positive for persons who do not meet any of the above criteria.

    d) Recent converters are defined on the basis of both induration and age:

  • greater than or equal to 10 mm within a 2 year period is classified as positive for persons greater than 35 years of age.
  • greater than or equal to 15 mm within a 2 year period is classified as positive for persons 35 years of age or older.
  • greater than or equal to 5 mm increases under the circumstances noted above in 6a).
    •

    (See attached October 28, 1994 CDC Report: "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities", 1994)

    6. Tuberculosis Contact Investigation

    The Student Health Service Director will be notified immediately of any diagnosed or reasonably suspect case of active TB of any Student Health Service employee with a PPD conversion or positive PPD skin test result to the initial screening test or if any Student Health Service HCW develops symptoms of active TB

    All diagnosed or reasonably suspect cases of active TB will be reported immediately to the Division of Public Health - State of Delaware. It is the responsibility of the Division of Public Health to investigate the source case of active tuberculosis and investigate contacts to this case (i.e. HCW to patient, patient to HCW, and patient to patient transmission).

    WARNING

    SPECIAL RESPIRAT0RY ISOLATION

    Persons entering this room must wear a face mask, gloves and laboratory coat at all times!

    8. Glossary

    This glossary contains many of the terms used in this TB control plan.

    BCG vaccine (Bacillus of Calmette and Guerin): A TB vaccine used in many parts of the world.

    Booster phenomenon: A phenomenon in which some persons (especially older adults) who are skin tested many years after infection with M. tuberculosis have a negative reaction to an initial skin test, followed by a positive reaction to subsequent skin test. The second (i.e., positive) reaction is caused by a boosted immune response. Two-step testing is used to distinguish new infections from boosted reactions (see two-step testing).

    Chemotherapy: Treatment of an infection or disease by means of oral or injectable drugs.

    Contact: A person who has shared the same air with a person who has infectious TB for a sufficient amount of time to allow possible transmission of M. tuberculosis.

    Droplet nuclei: Microscopic particles (i.e., 1-5um in diameter) produced when a person coughs, sneezes, shouts, or sings. The droplets produced by an infectious TB patient can carry tubercle bacilli and can remain suspended in the air for prolonged periods of time and be carried on normal air currents in the room.

    Exposure: The condition of being subjected to something (e.g., infectious agents) that could have a harmful effect. A person exposed to M.tuberculosis does not necessarily become infected (see Transmission).

    HEPA (high-efficiency particulate air) filter: A specialized filter that is capable of removing 99.97% of particles >0.3um diameter and that may assist in controlling the transmission of M.tuberculosis. Filters may be used in ventilation systems to remove particles from the air or in personal respirators to filter air before it is inhaled by the person wearing the respirator. The use of HEPA filters in ventilation systems requires expertise in installation and maintenance.

    Human immunodeficiencv virus (HIV) infection: Infection with the virus that causes acquired immunodeficiency syndrome (AIDS). HIV infection is the most important risk factor for the progression of latent TB infection to active TB

    Immunosuppressed: A condition in which the immune system is not functioning normally (e.g., severe cellular immunosuppression resulting from HIV infection or immunosuppressive therapy). Immunosuppressed persons are at greatly increased risk for developing active TB after they have been infected with M.tuberculosis. No data are available regarding whether these persons are also at increased risk for infection with M.tuberculosis after they have been exposed to the organism.

    Induration: An area of swelling produced by an immune response to an antigen. In tuberculin skin testing or anergy testing, the diameter of the indurated area is measured 48-72 hours after the injection, and the result is recorded in millimeters.

    Infection: The condition in which organisms capable of causing disease (e.g., M.tuberculosis) enter the body and elicit a response from the host's immune defenses. TB infection may or may not lead to clinical disease.

    Infectious: Capable of transmitting infection. When persons who have clinically active pulmonary or laryngeal TB disease cough or sneeze, they can expel droplets containing M. tuberculosis into the air. Persons whose sputum smears are positive for AFB are probably infectious.

    Intradermal: Within the layers of the skin.

    Mantoux test: A method of skin testing that is performed by injecting 0.1 ml of PPD-tuberculin containing 5 tuberculin units into the dermis (e.g., the second layer of skin) of the forearm with a needle and syringe. This test is the most reliable and standardized technique for tuberculin testing (see Tuberculin skin test and Purified protein derivative (PPD)-tuberculin test).

    Mycobacterial tuberculosis complex: A group of closely related mycobacterial species that can cause active TB (e.g., M.tuberculosis, M.bovis, and M.africanum); most TB in the United States is caused by M.tuberculosis.

    Pathogenesis: The pathologic, physiologic, or biochemical process by which a disease develops.

    Positive PPD reaction: A reaction to the purified protein derivative (PPD)-tuberculin skin test that suggests the person tested is infected with M. tuberculosis. The person interpreting the skin-test reaction determines whether it is positive on the basis of the size of the induration and the medical history and risk factors of the person being tested.

    Preventive therapy: Treatment of latent TB infection used to prevent the progression of latent infection to clinically active disease.

    Purified protein derivative (PPD)-tuberculin: A purified tuberculin preparation that was developed in the 1930's and that was derived from old tuberculin. The standard Mantoux test uses 0.1 ml of PPD standardized to 5 tuberculin units.

    Purified protein derivative (PPD)-tuberculin test: A method used to evaluate the likelihood that a person is infected with M.tuberculosis. A small dose of tuberculin (PPD) is injected just beneath the surface of the skin, and the area is examined 48-72 hours after the injection. A reaction is measured according to the size of the induration. The classification of a reaction as positive or negative depends on the patient's medical history and various risk factors (see Mantoux test).

    Purified protein derivative (PPD)-tuberculin test conversion: A change in PPD test results from negative to positive. A conversion within a 2-year period is usually interpreted as new M.tuberculosis infection, which carries an increased risk for progression to active disease. A booster reaction may be misinterpreted as a new infection (see Booster phenomenon and Two-step testing).

    Radiography: A method of viewing the respiratory system by using radiation to transmit an image of the respiratory system to film. A chest radiograph is taken to view the respiratory system of a person who is being evaluated for pulmonary TB Abnormalities (e.g., lesions or cavities in the lungs and enlarged lymph nodes) may indicate the presence of TB

    Resistance: The ability of some strains of bacteria, including M.tuberculosis, to grow and multiply in the presence of certain drugs that ordinarily kill them; such strains are referred to as drug-resistant strains.

    Smear (AFB smear): A laboratory technique for visualizing mycobacteria. The specimen is smeared onto a slide and stained, then examined using a microscope. Smear results should be available within 24 hours. In TB a large number of mycobacteria seen on an AFB smear usually indicates infectiousness. However, a positive result is not diagnostic of TB because organisms other than M. tuberculosis may be seen on an AFB smear (e.g., nontuberculous mycobacteria).

    Source case: A case of TB in an infectious person who has transmitted M.tuberculosis to another person or persons.

    Symptomatic: Having symptoms that may indicate the presence of TB or another disease.

    Transmission: The spread of an infectious agent from one person to another. The likelihood of transmission is directly related to the duration and intensity of exposure to M.tuberculosis (see Exposure) and the area is examined 48-72 hours after the infection. A reaction is measured according to the size of the induration. The classification of a reaction as positive or negative depends on the patient's medical history and various risk factors (see Mantoux test, PPD test).

    Tuberculosis: TB A clinically active, symptomatic disease caused by an organism in the M. tuberculosis complex (usually M.tuberculosis or, rarely, M. bovis or M.africanum).

    Tuberculosis infection: A condition in which living tubercle bacilli are present in the body but the disease is not clinically active. Infected persons usually have positive tuberculin reactions, but they have no symptoms related to the infection and are not infectious. However, infected persons remain at lifelong risk for developing disease unless preventive therapy is given.

    Two-step testing: A procedure used for the baseline testing of persons who will periodically receive tuberculin skin test (e.g., HCW's) to reduce the likelihood of mistaking a boosted reaction for a new infection. If the initial tuberculin-test result is classified as negative, a second test is repeated 1-3 weeks later. If the reaction to the second test is positive, it probably represents a boosted reaction. If the second test result is also negative, the person is classified as not infected. A positive reaction to a subsequent test would indicate new infection (i.e., a skin-test conversion) in such a person.

    The following assisted with information, forms, personal communication and resource documents in the preparation of the protocol.