| Tuberculosis Screening, Definitions & Concepts, References, Guideline, Information |
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| Tuberculosis Screening |
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Infection vs. Active Disease
Infection: The person is infected with TB bacteria. The person's immune system is controlling the TB, and the person is not ill. TB infection can only be identified through a positive skin test. This is called Latent TB infection or LTBI.
Active Disease: The TB bacteria in an infected person become active, multiply, and make the person ill. Symptoms of illness are present and/or radiographic lesions are seen. Only persons with active Tuberculosis disease may be contagious.
Treatment of Latent TB Infection (LTBI)
Formerly known as Chemoprophylaxis or Preventive Therapy, this refers to giving anti-tuberculosis medication to someone who is infected with MTB but does not have active disease, to prevent progression to active disease. Treatment is usually with a single drug, INH.
Treatment of Active TB Disease
This refers to giving anti-tuberculosis medications to someone who is ill with TB. In Oregon, initiation of treatment should be with the standard four-drug regimen.
Reactor
A person who has a positive reaction to PPD skin testing and who does not have a prior documented negative test.
Converter
A person who had a prior negative PPD skin test, and now, within the past two years, has a positive reaction to the PPD test.
Medical Risk Factors
Are concurrent medical conditions which make it more likely that once infected, the patient will go on to develop active TB disease.
INH-Resistant TB
This is a case of active TB that is resistant to INH.
Multi-Drug Resistant (MDR) TB
This is a case of active TB, which is resistant to at least INH and Rifampin, and perhaps also to other TB medications. INH and Rifampin are the foundation of adequate therapy for TB; without the ability to use these two drugs, the chance for cure decreases dramatically.
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| Definitions and Concepts |
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Infection vs. Active Disease
Infection: The person is infected with TB bacteria. The person's immune system is controlling the TB, and the person is not ill. TB infection can only be identified through a positive skin test. This is called Latent TB infection or LTBI.
Active Disease: The TB bacteria in an infected person become active, multiply, and make the person ill. Symptoms of illness are present and/or radiographic lesions are seen. Only persons with active Tuberculosis disease may be contagious.
Treatment of Latent TB Infection (LTBI)
Formerly known as Chemoprophylaxis or Preventive Therapy, this refers to giving anti-tuberculosis medication to someone who is infected with MTB but does not have active disease, to prevent progression to active disease. Treatment is usually with a single drug, INH.
Treatment of Active TB Disease
This refers to giving anti-tuberculosis medications to someone who is ill with TB. In Oregon, initiation of treatment should be with the standard four-drug regimen.
Reactor
A person who has a positive reaction to PPD skin testing and who does not have a prior documented negative test.
Converter
A person who had a prior negative PPD skin test, and now, within the past two years, has a positive reaction to the PPD test.
Medical Risk Factors
Are concurrent medical conditions which make it more likely that once infected, the patient will go on to develop active TB disease.
INH-Resistant TB
This is a case of active TB that is resistant to INH.
Multi-Drug Resistant (MDR) TB
This is a case of active TB, which is resistant to at least INH and Rifampin, and perhaps also to other TB medications. INH and Rifampin are the foundation of adequate therapy for TB; without the ability to use these two drugs, the chance for cure decreases dramatically.
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| References |
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Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care facilities, 1994. MMWR Oct. 1994; 43 (No. RR-13): 1-132.
Centers for Disease Control and Prevention. Prevention and control of tuberculosis in correctional facilities: Recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1996; 45(No. RR-8): 1-27.
American Thoracic Society. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med 161. S221-S247, 2000.
Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000; 49 (No. RR-6): 1-51.
Centers for Disease Control and Prevention. Core Curriculum on Tuberculosis. What the Clinician Should Know. 4th Edition, 2000.
Centers for Disease Control and Prevention. Controlling TB in Correctional Facilities. 1995.
American Thoracic Society. Treatment of tuberculosis and tuberculosis infection in adults and children. Am Rev Respir Dis. 1994
U. S. Department of Health and Human Services, et al. Self-Study Modules on Tuberculosis. March 1995; Volumes 1 through 5. Atlanta, Georgia.
Centers for Disease Control and Prevention. Prevention and treatment of tuberculosis among patients infected with human immunodeficiency virus: Principles of therapy and revised recommendations. MMWR 1998; 47 (No. RR-20): 1-58.
American Thoracic Society. Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care Med 2000; 161: 1376-1395.
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| Guideline for Compliance |
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TB Testing and Treatment Compliance Guideline
PURPOSE: Written guidelines developed to assist staff in knowing how to handle those inmates that initially refuse to comply with screening and/or treatment for tuberculosis infection or disease.
SUBJECT: Inmate refusal to participate in yearly tuberculosis screening and/or treatment for LTBI or tuberculosis disease.
PHILOSOPHY: Tuberculosis is the #1 cause of death from communicable disease in the world. furthermore, the Centers for Disease Control has determined that Tuberculosis is a health problem in prisons. As stewards of public health, correctional health care professionals have an obligation to screen for and prevent the spread of tuberculosis within the correctional setting.
By refusing to participate in the yearly screening and/or treatment for latent TB infection or tuberculosis disease, these individuals have demonstrated that they are non-compliant and require unique care and attention. Non-compliance indicates that the individual does not have a thorough understanding of the dangers of tuberculosis to themselves and others. The purpose of this special attention is to assure that these individuals are not contagious and in danger of spreading the tuberculosis germ within the correctional environment.
In as much as tuberculosis is highly contagious and easily spread through the air, monitoring of individuals that are non-compliant must be accomplished when health services staff have adequate time to complete the monitoring and when there is the least danger of spreading the disease to other individuals.
PROCEDURE:
A. All inmates are screened for tuberculosis at intake and yearly as directed by the Oregon Department of Corrections Tuberculosis Protocol. The Tuberculosis Protocol also provides direction for the treatment of both Latent TB infection (as indicated by a positive PPD) and tuberculosis disease.
B. A chest x-ray is not a replacement for symptom screening or PPD testing.
C. Inmates that refuse yearly tuberculosis screening will be:
- Scheduled with a tuberculosis coordinator for education and discussion of the refusal.
- Should the inmate still choose to refuse to be screened, he/she will be placed on a call-out to be screened and observed for signs and symptoms of tuberculosis and educated about tuberculosis. Screening and observation will consist of the patient answering the TB SYMPTOM OBSERVATION FLOW SHEET questions, chest auscultation, weekly weight, and direct observation of the patient for any signs and symptoms of active tuberculosis disease.
- Call-outs for general population inmates will occur daily at a time that is at the discretion of the health services staff depending upon individual and health services needs and operations. Call-out times are Institution-specific, and are indicated on the TB SYMPTOMS OBSERVATION FLOW SHEET.
- Screening for disciplinary segregated/IMU inmates will occur during daily checks. Additionally, the patient will be scheduled once a week at a time that is at the discretion of the health services staff depending upon individual and health services needs and operations, to have lungs auscultated, weight taken, and to be assessed for signs and symptoms of tuberculosis in the segregation clinic area.
- Screening for administratively segregated inmates will occur daily. Additionally, the patient will be scheduled once a week at a time that is at the discretion of the health services staff depending upon individual and health services needs and operations, to have lungs auscultated, weight taken, and to be assessed for signs and symptoms of tuberculosis in the administrative segregation clinic area.
- Other Institution-specific information may be attached but may be adjusted for any individual.
D. Inmates that refuse to participate in treatment of latent TB infection or in treatment of TB disease, when indicated, will be treated the same as inmates that refuse tuberculosis screening (see 3. above).
E. Inmates that are non-compliant for either screening or treatment may also be scheduled once a month with the Chief Medical Officer or designee as long as non-compliance continues.
F. At any point in time that the individual chooses to be screened by administration of a PPD and/or comply with treatment, the special monitoring described above is discontinued and the individual is monitored as directed by the Tuberculosis Protocol.
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| PPD Mantoux Protocol |
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I. Mantoux
This test is the intradermal injection of Purified Protein Derivative. In this department, the terms Mantoux and PPD (Purified Protein Derivative) are used interchangeably. PPD is a highly purified protein fraction isolated from culture filtrates of human type strains of Mycobacterium Tuberculosis. The Mantoux test or PPD is the method routinely used in this department. The standard dose is 5 tuberculin units (5 TU) per 0.1ml.
A. Dosage and Administration
- Mantoux
PPD solution adheres to the plastic walls of syringes and thus should not be drawn up in advance and left to sit. Injection is made intradermally on the flexor surface of the left forearm. The site is first cleansed with alcohol and dried with a cotton ball or 2x2. Hold the skin of the forearm taut. Inject 0.1 cc PPD solution containing 5 TU (tuberculin units) from a tuberculin syringe with at least a ½ inch 26- or 27-gauge needle. If placed correctly, a 6-10 mm wheal will be formed. Care should be taken to avoid injecting solution subcutaneously. If this occurs, no local reactions develop (or it may be too deep to find and measure correctly), and a general febrile reaction may result.
- Positioning the Needle
Stretch the subject's skin taut between your thumb and index finger. Face the bevel of the needle upward and hold the needle and syringe almost parallel to the skin.
- Insert properly- Insert the needle just beneath the skin surface. When placed properly, you should be able to see the needle under the epidermis. Inject all the tuberculin. A tense white wheal, 6-10 mm in diameter, should appear.
- The Needle is Too Deep (incorrect)
The needle has been placed too deeply if you can't see the needle under the epidermis, you feel little resistance as the tuberculin enters, and you see a shallow, diffuse bulge instead of a tense white wheal. This results in a very shallow induration that is very difficult to measure and is impossible to interpret. Needle placement should be just past the edge of the bevel. The further the needle is inserted, the more likely the test will be placed too deeply (e.g., Subcutaneously). Do not inject tuberculin subcutaneously. If the wheal measures less than 6 mm in diameter, it is placed too deeply, and a second test should be placed on the other arm.
- The Needle is Too Shallow
The bevel will barely penetrate the epidermis. Tuberculin will be seen leaking from the injection site onto the surface of the skin. To avoid this, be sure to insert the needle just past the end of the bevel (being careful not to insert too far).
Note: If there was leakage, and the wheal is < 6 mm in diameter, repeat the test and document in patient's chart.
- Contraindications
- Those already diagnosed with culture-positive active tuberculosis.
- Those with a documented previous positive skin test with a mm result.
II. Mantoux Results
A. Readings: TB skin tests are measured 48 to 72 hours after injection.
- A reaction usually consists of both induration and erythema. Measure only the induration. The erythema has no diagnostic value; ignore it.
- Find the margin of induration by touch, drawing the index or middle finger lightly across the reaction. Mark the edge of the induration using a ballpoint pen. Mark the left side, then the right side.
- For standardization, the diameter of induration should be measured transversely to the long axis of the arm.
- Using a millimeter ruler, measure the diameter of the reaction, by noting the number of millimeters between the edges you marked with the ballpoint pen. If the reading falls between two whole number measurements, report as the lower of the two.
- B. Recording Results
- Measure all measurements in mm of induration, not + or -.
- If there is no induration the measurement is 0 (0 mm).
- C. Interpretation of Results
- Positive Reactions:
a. 5 mm and larger is positive for the following inmates:
1) HIV + or suspected HIV + (encourage testing).
2) A close contact to an infectious case.
3) A chest x-ray indicates previous active TB.
b. 10 mm and larger is positive for all other inmates.
- Negative Reactions:
Any millimeter reaction smaller than the cut-points described above.
- False Negative and Positive Reactions:
Four to nine mm induration is the gray area of intermixed "false-positives" and "false-negatives."
a. "False-negative" results may be caused by:
· People with weakened immune systems
· People recently infected with M. tuberculosis (within the past 10 weeks)
· Immunization with a live viral vaccine within the last month (MMR,varicella).
· Children younger than 6 months old
· Problems with tuberculin solution
Improper handling
Dilutional errors
Storage in light, heat, or excessive cold
Contamination
Absorption to container walls
· Errors in technique
Incorrect administration
Wrong amount given
Subcutaneous injection
Absorption to syringe walls following delayed administration
Incorrect interpretation
Inexperience in detecting induration
Errors in recording
b. "False-positive" results may be caused by:
· Measurement of erythema
· Cross-reactions to other Mycobacteria which are non-tubercular such as M. Marinum, M. Avium-intracellulare, M. Kansasii, (there are >30 identified other species)
· Reactions to impurities in the tuberculin solution
· People vaccinated with BCG (Note: most reactions caused by BCG are less than 10 mm).
- D. Counseling Inmates:
Explain the significance of the positive or negative reactions. Several different handouts are available and are included in this protocol
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| Patient Information |
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Tuberculosis (TB) used to be one of the leading causes of death in the United States, and it still is in many parts of the world.
TB is spread when someone who has active disease coughs, sings, or speaks, and someone else breathes in the air contaminated with TB germs into their lungs. There the germs can multiply. They can also travel to other parts of the body.
The body's immune system can usually fight off the germs and wall them off. The person is infected with tuberculosis, but does not have disease. The person feels fine, has a normal chest x-ray, and cannot spread the disease to others. The only way to tell that this person has TB infection is to do a special skin test by injecting a tiny bit of protein from a culture broth in which TB germs were grown (this material does not contain any germs and cannot give people TB) to see if the person later reacts to it - it is like an allergy test.
The person infected with TB may remain well for awhile or can develop disease. Disease is more likely to occur if his or her immune system becomes weak due to age, infection with HIV, cancer, or other causes.
A medication called INH can be taken to help prevent TB infection from becoming disease, but it must be taken for several months, and it can sometimes cause liver problems. People who take INH are checked regularly to make sure they don't develop symptoms of liver problems such as yellow eyes or skin, abdominal pain, dark urine, nausea and vomiting. Most people who take INH have no problem with it.
People who don't or can't take the medication may develop active TB disease if their immune system weakens. Usually the symptoms include a persistent cough, sometimes with blood, weight loss, fatigue, fever and night sweats. If you have ever had TB infection, you need to get medical attention if you develop any of these symptoms to be sure you do not have active TB disease, which is usually confirmed with a chest x-ray and sputum test.
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| Latent TB Infection |
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I. INTRODUCTION
Treatment of latent TB infection (LTBI) will play a crucial role in efforts to eliminate tuberculosis in the United States. When taken as prescribed, isoniazid (INH) is highly effective in preventing latent tuberculosis infection from progressing to clinically apparent disease (CDC, 2000). Despite proven effectiveness, INH is under-used. INH alone is, of course, inadequate for treatment of a patient with active disease.
Incarcerated persons are one group cited as having increased risk for developing active tuberculosis. Additional factors (recent converters, immunosuppression, foreign-born, the medically under-served, or those with medical conditions known to increase the risk of tuberculosis) may further increase risk of Tuberculosis infection and disease.
Experience has shown that a large number of offenders report previously reactive Mantoux skin tests, and that often, preventive therapy was not offered or not taken as prescribed. Since it is believed that most active cases occur among persons previously infected (CDC, 2000), it is imperative that the Department of Corrections continue education, intervention, and evaluation of interventions designed to prevent active tuberculosis. It is believed that monthly education to inmates about tuberculosis and the importance of taking preventive medication as directed will increase compliance rates.
II. ROLE OF THE TB COORDINATOR
Each institution's TB Coordinator is not only the gatekeeper into the Department's TB prevention program but also the resident nursing TB expert. Not only will the TB nurse educate staff and inmates about tuberculosis, but he/she will assume the primary investigative role if an active case is discovered. Monthly epidemiological record keeping is also an important aspect of this role.
Additional responsibilities include utilizing the Inmate Health Plan [Special Needs TB Meds indicates INH use, Special Needs TB indicates active disease on treatment] to monitor inmates who qualify for LTBI and assuring that health care documentation is kept up-to-date. The TB nurse consults and collaborates with other institution TB Coordinators and TB Practitioners and may have the opportunity to consult with state or national experts (Oregon Health Division/TB Control, or the Centers for Disease Control) in certain cases. In summary, the TB Coordinator provides structure, strength and expertise to a department-wide program that depends upon continued institutional involvement to be successful.
III. PREVENTION OF TUBERCULOUS DISEASE
Treatment of LTBI substantially reduces the risk of developing active TB in infected persons. All persons who have a positive skin test should be considered for preventive therapy when active disease has been ruled out. Highest priority for LTBI treatment should go to skin test positive persons most likely to develop active disease.
A. Medical Risk Factors
The following high-risk groups regardless of age are a priority for treatment of LTBI:
- persons with HIV disease
- close contacts of infectious TB cases
- recent tuberculin converters (within a two (2) year period)
- previously untreated or inadequately treated persons with abnormal chest x-rays consistent with old, healed TB
- injecting drug users
- persons with medical conditions that increase the risk of TB if infected, including:
- silicosis
- diabetes mellitus
- prolonged corticosteroid therapy
- immunosuppressive therapy
- hematologic and reticuloendothelial diseases (leukemia, lymphoma, etc.)
- end-stage renal disease
- intestinal bypass
- post-gastrectomy
- chronic malabsorption syndrome
- carcinomas of the oropharynx and upper gastrointestinal tract
- being 10% or more below ideal body weight
B. Persons < 35 years old
The next highest priority patient for preventive therapy is skin-test positive persons who are less than 35 years of age. They should be considered for preventive therapy regardless of the above risk factors because of the very low incidence of INH side effects and because they represent a large pool of primary infected persons, who, because they are young, are more likely to have been recently infected.
C. Others
The third priority should be given to patients above age 35 with no medical risk factors. All these patients should be considered for INH prophylaxis. The mean range of Active TB cases is 25-45 with median age in Oregon of 43. The risk of TB breakdown increases with advancing age, as does the risk of INH-induced chemical hepatitis, which is exceedingly rare in persons under 20, but increases to 2.3% in individuals over 50.
If PPD conversion is known to have occurred over 2 years before and there are no priority indications for INH prophylaxis, INH should be offered, but if not taken, the inmate must undergo an annual review for signs and symptoms of TB. A chest x-ray is done only if clinically indicated.
IV. EVALUATION FOR TREATMENT OF LATENT TB INFECTION
General Eligibility Standards. In order to be eligible for consideration for treatment of latent TB infection (LTBI), the inmate will:
A. Be consistent with taking medications for a minimum of six (6)
months.
B. Not be pregnant.
C. NOT demonstrate any symptoms of active TB disease.
If any of these conditions are not met in a person who is a recent TB converter or case contact, he/she should be referred to the TB practitioner.
Specific Diagnostic Standards. An inmate should never be started on treatment for latent TB infection before diagnostic work-up is reviewed and it is insured that he/she is free of signs and symptoms of active TB disease. Treatment of active disease with single drug therapy can lead to drug resistant disease.
Specific Educational Standards. Once an inmate is deemed appropriate for treatment of LTBI, and before an inmate is placed on treatment, it is necessary for the institution's TB Coordinator to provide appropriate education, which includes the following information:
- the difference between exposure, infection, and disease;
- cause and spread of tuberculosis infection;
- why the medication is being recommended;
- importance of taking the medication as directed;
- DOC policy regarding direct observed treatment;
- side effects of INH;
- length of treatment.
If the inmate agrees to treatment, such treatment should be ordered. If the inmate declines treatment of LTBI, the inmate may be referred to the TB practitioner. If the inmate still refuses, s/he should be informed about signs and symptoms of TB disease, the need to seek medical care for such signs and symptoms, and that annual sign and symptom review will be done by ODOC Health Services. See also section on Guideline for Tuberculosis Testing/Treatment Compliance.
V. DOCUMENTATION AND FOLLOW-UP OF REACTORS
Usual Documentation. The following are documentation standards within the Department of Corrections Health Service Division:
A. TREATMENT OF LATENT TUBERCULOSIS INFECTION form (OHD Form 48-17A). This form should be used for all inmates who begin treatment for LTBI.
B. Schedule an appointment with the institution's TB Coordinator or his/her designee for initial evaluation.
C. Enter the inmate into the Special Needs group in the computer
under TB Meds, which indicates INH use.
D. Document results of the initial evaluation in the progress notes of the health care record.
E. If the inmate requires TB practitioner evaluation, schedule an
appointment and write the reason for referral on the progress note. It is recommended that inmates over 35 years old and inmates with active liver disease, peripheral neuropathy, or multiple medications be referred to the TB practitioner.
The TB Coordinator assures that the documentation process includes all inmates who, by the DOC TB Screening Protocol or Contact Investigation Protocol are eligible for LTBI treatment.
Follow-Up Interviews. Nursing follow-up for inmates prescribed LTBI therapy should focus on these areas:
A. Ongoing education that includes explanation of the difference
between TB infection and disease, information about signs and symptoms of active disease and the importance of compliance with treatment.
B. Presence/absence of signs and symptoms of side effects
associated with INH treatment.
C. Document follow-up interviews on the bottom half of the
TREATMENT OF LATENT TUBERCULOSIS INFECTION form (OHD Form 48-17A).
D. The TB nurse may send the inmate an INH monitoring
questionnaire (this form is not considered a part of the health care record) to remind him/her of their monthly appointment. Information should be transferred to the TREATMENT OF LATENT TUBERCULOSIS INFECTION form (this form is considered a part of the health care record).
E. Evaluation of compliance by scrutinizing the inmate's medication
administration record (MAR) and keeping a tally of number of doses missed. It is imperative that inmates comply with therapy. Consult with or refer to the TB practitioner when the inmate is noted to be non-compliant.
Follow-up interviews should continue on a monthly basis until treatment is discontinued.
Radiographic Follow-Up.
Chest X-rays are recommended for follow-up in selected cases. Guidelines have been established by the Centers for Disease Control and discussed with the Oregon Health Division TB Control. These guidelines are endorsed by the Oregon Department of Corrections.
A chest X-ray should be obtained:
A. when the positive Mantoux test is noted, to rule out active pulmonary disease or evidence of past active disease.
B. whenever clinical signs and symptoms suggest tuberculosis disease.
C. at completion of treatment of active tuberculous disease to have a baseline for future comparison. Routine chest X-rays are not indicated unless there is a concern over clinical response to treatment.
If, at any time, the chest X-ray shows evidence of active disease, the inmate should be placed in AFB isolation, collection of sputum samples begun and the TB practitioner notified.
VI. DISCONTINUATION OF TB MONITORING
A. Successful Completion of Treatment of Latent TB Infection. When an inmate has completed six or nine months (52 or 76 doses respectively) of treatment, he/she is considered cured of TB infection. Documentation requirements include:
- Completion of the TREATMENT OF LATENT TUBERCULOSIS INFECTION form (OHD Form 48-17A). Send a copy of the long form to the Oregon Health Division within two (2) weeks after the case is closed.
- Remove the patient's name from the Special Needs list.
- Write on the inmate's problem list that treatment for
LTBI has been completed and make a similar note in the progress notes.
- Screen annually for symptoms using the TUBERCULOSIS FLOW SHEET (green sheet).
Follow-up chest x-rays are not needed unless clinically indicated by sign and symptom review.
B. Failure to Successfully Complete Treatment of LTBI. If the TB practitioner terminates treatment, he/she should complete the following documentation requirements.
- Note the reason for the medical need for termination on the inmate's progress note as well as the inmate's problem list.
- On the Health Division's TREATMENT OF LATENT TUBERCULOSIS INFECTION form, the practitioner should note the reason for termination by checking the appropriate box at the bottom of the form. Send a copy to the Oregon Health Division. In addition, written documentation on the physician order sheet is necessary.
- Screen annually for symptoms using the TUBERCULOSIS FLOW SHEET (green sheet).
VII. TREATMENT FOR LATENT TUBERCULOUS INFECTION (LTBI)
Currently, there are four and three acceptable treatment regimens for latent tuberculosis infection in HIV-negative and HIV-positive individuals respectively (Core Curriculum, 2000). Although the nine-month INH treatment regimen is preferred in the individual HIV-negative or HIV-positive patient, a six-month regimen also provides acceptable protection in the HIV-negative adult. Treatment can be daily or twice weekly, but the twice-weekly regimen is preferred because it is more cost effective. This is the usual ODOC treatment for LTBI.
INH is a very effective and safe medication. When indicated, the six month INH regimen is a preferred treatment for pregnant women. Peripheral neuropathy is a rare side effect in the usual doses given. Because some of our patients may be at risk for peripheral neuropathy (eg. Diabetics, alcoholics, malnourished individuals, individuals with seizure disorders), we routinely offer pyridoxine (vitamin B6), 50 mg/day with INH.
INH is contra-indicated in persons with severe active hepatitis or end-stage liver disease.
These are the standard regimens:
- For HIV-negative individuals, a six-month twice-weekly regimen should consist of at least fifty-two (52) doses, and must be completed within nine (9) months.
- For HIV-positive individuals and for individuals with fibrotic lesions on chest x-ray, a regimen of seventy-six (76) twice-weekly doses is necessary. It must be completed within twelve (12) months.
A TB practitioner must be consulted if other treatment regimens are contemplated.
A. Medications and Dosage
Thus, the patient has arrived at this point by practitioner order or application of TUBERCULOSIS FLOW SHEET (green sheet). Active tuberculosis has been ruled out. The standard treatment regimen is INH for 6-9 months, with close monitoring as follows:
INH 900 mg p.o. twice weekly
WITH
Pyridoxine 50 mg p.o. twice weekly
B. Length of Treatment
- HIV-Negative Inmates Six (6) months: a total of 52 doses (given within nine months).
- HIV-Positive Inmates
Nine (9) months: a total of 76 doses (given within 12 months).
NOTE: Any inmate who has not received 52 or 76 doses by nine or 12 months respectively should be brought to the attention of the TB practitioners. It is imperative that inmates comply with therapy. Thus, all tuberculosis chemotherapy is DIRECTLY OBSERVED THERAPY. For a patient on twice weekly therapy, missing more than four consecutive (two total weeks) or four doses scattered throughout the length of preventive therapy should prompt the nurse to evaluate why this is occurring. If the inmate becomes non-compliant or is unable to complete the recommended doses in the recommended time period, contact a TB practitioner. Also, see the section Guideline for Tuberculosis Testing/Treatment Compliance.
C. Monitoring While on Treatment
- Baseline comprehensive chemistry panel, to include liver function tests.
- Patients with a history of liver disease or multiple medications may need to have chemistry panels done monthly initially, or may need medication (e.g., Dilantin) levels. Consult with a TB practitioner.
- Monthly compliance and side effect monitoring.
D. Follow-up (whether or not infected inmate completes treatment with INH).
- Chest x-rays: Routine annual chest x-ray follow-up is no longer recommended (CDC,1996). Chest x-rays should be obtained only if symptoms and signs suggest that active pulmonary disease is occurring.
- All skin test reactors, regardless of whether or not they have completed a course of INH, need to be aware of the signs and symptoms of tuberculosis, and be instructed to seek immediate medical attention if they experience any of these. These inmates need to have an annual review for signs and symptoms of active tuberculosis, using the TUBERCULOSIS FLOW SHEET (green sheet).
E. Documentation for inmates with latent TB Infection on INH therapy
includes: (see Forms section)
- The Medication Administration Record (MAR).
- TREATMENT OF LATENT TUBERCULOSIS INFECTION form (OHD 48-17A), formerly known as CHEMO-PROPHYLAXIS CONSIDERATION FORM.
- Treatment LTBI INTER-JURISDICTIONAL TRANSFER NOTIFICATION
- INH MONITORING QUESTIONNAIRE
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| Active TB Disease |
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When symptoms and/or results of skin test, chest x-ray or sputum smear suggest active TB, the suspected case should be isolated, reported to the public health authority (local health department), and sputums for smear and culture obtained. A TB treatment regimen consisting of at least four drugs should be used pending susceptibility test results. Because of the severe course of TB in patients with HIV disease, all active TB patients should have an HIV test done. Up to 70% of HIV/TB patients develop both pulmonary and extra pulmonary TB.
I. DIAGNOSIS
A positive bacteriologic culture for M. Tuberculosis is essential to confirm the diagnosis of active tuberculosis. Symptoms, history and PPD test results may be suggestive, but are not confirmatory. The chest x-ray may also be suggestive but is never diagnostic for tuberculosis.
INSTRUCTIONS FOR SPUTUM COLLECTION are included in the Forms section. Detection of Acid Fast Bacilli (AFB) in stained microscope smears may provide a presumptive diagnosis of tuberculosis but again is not confirmatory since AFB present on smear may, on culture growth, turn out to be a non-tuberculous mycobacterium. Only pulmonary and laryngeal TB may be contagious due to the aerosolized droplet nature of MTB infections.
To determine whether sufficient suspicion exists to isolate and treat for Pulmonary Tuberculosis, the following criteria for therapy, in decreasing order of certainty, have been developed. Any sputum positive for AFB should result in the isolation of the inmate until non-infectiousness is established.
A. Sputum culture positive MTB
B. Sputum smear positive AFB, clinical syndrome of TB with clinical response to TB Medication, no culture result available.
C. CXR suspicious for TB, positive PPD, clinical syndrome of TB with clinical response to therapy, but neither sputum smear nor AFB culture positive. This inmate is not considered infectious, therefore, no need to isolate.
D. CXR suspicious for TB, negative PPD, clinical syndrome of TB with clinical response to therapy, but neither sputum smear nor AFB culture positive. This inmate is not considered infectious, therefore, no need to isolate.
II. DOCUMENTATION/REPORTING
All patients suspected of active Tuberculosis or prescribed anti-Tuberculosis therapy must have a note in their chart documenting the criteria by which the suspicion or diagnosis was made. Enter patient into the computer Special Needs Group - TB. Any suspected or confirmed case of Tuberculosis disease must be reported to the public health authority (local health department) where case resides. Please see The Oregon TB Program´s TUBERCULOSIS CASE REPORTS INSTRUCTION GUIDE, which includes The INITIAL REPORT OF SUSPECT CASE OF TUBERCULOSIS (CDC 72.9A), The VERIFICATION REPORT and The COMPLETION REPORT, which must be submitted. (see FORMS section)
III. ISOLATION
To prevent the spread of TB infection to staff and inmates, persons suspected of having active TB should be placed in AFB isolation whenever possible until risk of infecting others has been removed by further workup or by treatment. Immediate transport to an isolation (negative pressure) room is indicated. While awaiting transport, the inmate, wearing a mask, may wait in the waiting room of Health Services (unless a more appropriate waiting area is designated).
IV. NON-INFECTIOUSNESS
A. Non-infectiousness can be established when ALL four (4) factors listed below are met:
- Three (3) consecutively collected sputum specimens (collected on different days) are AFB-smear negative, and
- There is a clinical response to treatment (resolution of cough, fever, etc.), and
- Inmate has had at least two (2) weeks of appropriate TB treatment, and
- Inmate will continue on appropriate DOT treatment for TB.
B. For patients who have non-pulmonary TB, or based on further evaluation are no longer suspected of having TB, consult with your TB practitioner, or Chief Medical Officer, or the Medical Director for the Oregon Department of Corrections as needed.
V. TREATMENT
When active tuberculosis disease is suspected, the suspected case should be placed on a TB treatment regimen consisting of four (4) drugs until TB has been ruled out. The incidence of INH resistance in Oregon exceeds 4%, thus the recommendation for four-drug therapy. Culture and sensitivity of appropriate specimens should be started prior to giving antibiotics. Compliance is a major issue in the treatment of TB. TB can relapse if a drug regimen is interrupted or ends too soon, and relapse is frequently accompanied by the emergence of drug resistant tubercle bacilli. TO MAKE SURE THAT INMATES TAKE THEIR MEDICATION, STAFF SHOULD DIRECTLY OBSERVE THE INGESTION OF EACH DOSE. Failure to take medications should be dealt with rapidly. Medication cannot be forced, but quarantine in respiratory isolation can be enforced.
VI. DRUG RESISTANCE
If INH or multi-drug resistant TB is suspected by exposure history or clinical course, the inmate should immediately be isolated and the Oregon Health Division and TB practitioners consulted for special recommendations.
INH resistance may be suspected in patients with symptoms of TB who have had prior inadequate or incomplete courses of treatment, or continuation or re-emergence of symptoms despite drug therapy, or patients with a history of exposure to INH resistant TB.
VII. INITIATION OF THERAPY
All patients must start anti-tuberculosis therapy with a DAILY schedule of four drugs. Isoniazid (INH), a Rifamycin (Rifampin-RIF or Rifabutin-RFB), Pyrazinamide (PZA), and Ethambutol (EMB) are the first choice medications and are given for eight (8) weeks. Patients are then given twice weekly INH and Rifamycin for 16 weeks (HIV negative cases) or 18 weeks (HIV positive cases) if their TB is susceptible to these medications. This twice weekly phase of therapy will last until six months of treatment have been received unless there is delayed response to treatment, in which case nine months or more may be necessary. Patients being treated for HIV have complex treatment requirements, and should be treated in consultation with a physician experienced in treating both TB and HIV.
RECOMMENDED DRUG REGIMENS FOR THE TREATMENT OF TUBERCULOSIS
Regimens HIV Negative HIV Positive
Initial Phase (2 months) INH/RIF/PZA/EMBEMB until susceptibility to INH and RIF confirmed Daily for 8 weeks INH/RFB/PZA/EMBDaily for 8 weeks
Continuation Phase (4 months) INH/RIF Daily or 2 times weekly for 16 weeks INH/RFBDaily or 2 times weeklyfor 18 weeks
Duration: Six (6) months unless there is a delayed response to therapy.
VIII. MEDICATION DOSAGE
DOSAGE OF DRUGS USED FOR THE TREATMENT OF TUBERCULOSISDrugs Used: Isoniazid (INH) 300 mg daily or 900 mg 2 times weekly Rifampin (RIF) 600 mg daily if inmate´s weight is > 50 Kg or 450 mg daily if < 50 Kg same dosages 2 times weeklyORRifabutin (RFB) if on HIV medications, consult with HIV/TB physicianPyrazinamide (PZA) 15-30 mg/Kg daily (maximum dose 2 g) or 50-70 mg/Kg 2 times weekly (maximum dose 4g)Ethambutol (EMB) 15-25 mg/Kg daily or 50 mg/Kg 2 times weekly
IX. MONITORING
TB MEDICATION MONITORING forms (see Forms section) will be filled out on all inmates started on anti-tuberculosis drugs to follow response, side effects and compliance.
A. Response to TB Treatment - Sputum and X-ray Monitoring
Response to treatment must be monitored since the development of drug resistance can be a problem. Persons with clinically active disease should be monitored monthly through sputum examination and culture until cultures convert to negative. These smears and cultures should be entered sequentially by date in the SPUTUM REPORT RECORD. Sputum smears are rapid and, if negative, indicate such low numbers of organisms as to not be contagious. Cultures, which take as long as 12 weeks, must be done monthly to check for complete clearance of living organisms.
Patients whose sputum no longer contains MTB after two (2) months of treatment should have at least one more sputum smear and culture done at completion of treatment. MDR TB patients should have them monthly throughout the course of their treatment.
If sputum doesn´t clear and/or symptoms resolve after three (3) months of treatment, evaluation for drug resistance or poor compliance should be done. If the treatment regimen is believed to be failing, it is best to wait for sensitivities to change the regimen, OR one can add two new drugs to the regimen. Never add one drug at a time.
Persistence or reappearance of organisms in sputum is alarming and is suspicious for non-compliance or drug resistance and experts should be consulted.
To follow sputum-negative patients, clinical signs and symptoms should be monitored monthly, and a chest x-ray should be obtained at three (3) months to help evaluate response to treatment. If the latter does not improve, while clinically, the patient does, there may be another pulmonary process occurring.
Chest x-ray at completion of therapy provides a baseline for future evaluations or comparisons. Further follow-up is not necessary for patients who had a prompt response to therapy with INH and RIF unless they develop signs and symptoms of illness, such as chronic cough, fever, and weight loss. INH or MDR TB patients may require individualized follow-up regimens. ALL patients should be advised to seek medical attention if they should develop such symptoms in the future.
B. For Medication Side Effects - TB MEDICATION MONITORING FORM
Staff should monitor all inmates taking anti-TB drugs at least monthly. Staff doing this monitoring should be familiar with common side effects and adverse reactions of the medications. The monthly monitoring must be formally documented on the TB MEDICATION MONITORING FORM in the inmate´s record.
Remember that the Rifamycins interact with many other medications (Dilantin, oral contraceptive pills, HIV medications) and color body fluids and contact lenses orange. Baseline vision checks should be done upon initiation and monthly when Ethambutol is used.
C. Non-compliance
Missing one week of medications should trigger nurse inquiry. Two weeks of non-compliance should trigger nurse and practitioner inquiry and may require re-isolation of the inmate. See also section Guideline for Tuberculosis Testing/Treatment Compliance.
D. For Completion of Treatment - TB Patient Follow-Up
All inmates who have started treatment and will be leaving the facility before completing their regimen should be referred to either the destination county health department or the Oregon Health Division TB Program with information regarding current status. The TB CASE/SUSPECT INTER-JURISDICTIONAL TRANSFER NOTIFICATION form may be used.
E. State Health Division Forms - See The TUBERCULOSIS CASE REPORTS INSTRUCTION GUIDE which contains the:
- INITIAL REPORT OF SUSPECT CASE OF TUBERCULOSIS.
- VERIFICATION REPORT OF SUSPECT CASE OF TUBERCULOSIS.
- COMPLETION REPORT OF SUSPECT CASE OF TUBERCULOSIS.
- TB CASE/SUSPECT INTER-JURISDICTIONAL TRANSFER NOTIFICATION.
- CURETB BINATIONAL TUBERCULOSIS Referral Form
- APPENDIX F
- APPENDIX
Forms 1, 2, and 3 are filled out when a case is suspected, confirmed or completes treatment respectively and are sent to The County Health Department of the county where the inmate is currently housed.
Form 4 is used when an inmate is transferred to another county or state, e.g., paroled.
Form 5, 6, and 7 do not generally pertain to ODOC.
Instructions for Sputum Collection
Sputum Report Record
TB Medication Monitoring Form (1st Line Meds)
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| Sputum Collection |
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1. DO NOT eat or drink, brush your teeth, smoke or use a mouthwash before you collect your sputum.
2. Collect sputum when you first get out of bed (early morning). Cough deeply in order to bring up sputum from the lungs, not saliva (spit) from the mouth.
Spit the sputum into the plastic bottle to, at least, the bottom line marked with number 5.
3. Please do this every day right after waking up, for three days in a row. Use a different bottle each day.
4. Close the plastic bottle top tightly. Write the date on the label of the bottle each day.
Sputum Report Record
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| Investigation and Control |
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Contact Investigation and Infection Control
CONTACT INVESTIGATION
I. Policy:
Upon identification of an active, communicable TB case, the Oregon Department of Corrections (ODOC) shall institute epidemiological investigation of possible transmission of tuberculosis. The investigation will include persons who may have been significantly exposed to this case within an ODOC institution. The Health Services Manager of each institution will ensure this is accomplished in a manner that complies with Oregon Health Division standards. Persons found to be significantly exposed who are not inmates, staff, or consultants shall be referred to the county health department or the Oregon Health Division.
II. Objectives:
To assure that for those individuals within the responsibility of ODOC:
A. All persons (contacts) exposed to infectious tuberculosis cases will be
informed of their exposure to receive appropriate medical evaluations.
B. All infected contacts and other identified high risk individuals will be
encouraged to undergo treatment so they will not become ill with disease and will be followed regularly to reduce any risk of infecting others.
C. All persons not infected with tubercle bacilli will remain uninfected.
D. All individuals who are able to infect others with tuberculosis will become
non-infectious and remain so by successfully completing adequate therapy.
III. Forms To Use:
Complete form packages that contain all forms related to TB case investigation and case reporting will be kept at ODOC Health Service central office and at each institution. The TB Coordinator in charge of assuring first circle testing will request a package of forms for each suspected or proven TB case.
Forms included in each Infection Control/Contact Investigation package are:
A. ODOC TB TIME LINE
B. TUBERCULOSIS EPIDEMIOLOGICAL WORKSHEET (OHD 42-63)
C. TUBERCULOSIS CONTACT INVESTIGATION RECORD (OHD 42-68)
D. CONTACT FOLLOW-UP INTERJURISDICTIONAL TRANSFER NOTIFICATION
E. SAMPLE LETTERS
IV. Procedure:
When a case of active pulmonary tuberculosis caused by Mycobacterium tuberculosis (MTB) has been strongly suspected or identified by smear and/or culture, the Health Service Manager/designee will initiate contact investigation by the use of Oregon Health Division and ODOC forms.
A. Freezing Inmate Movement
When investigating a case of pulmonary tuberculosis with significant cough, laryngeal tuberculosis, significantly positive smear, e.g., 4+, or a pulmonary cavity seen on chest X-ray, additional safeguards are necessary. If this condition occurs, contact ODOC Health Service Administration for assistance.
B. Investigating Potential Cases/Contacts
- ODOC TB TIME LINE
The ODOC TB TIME LINE is the first form in the packet and will assist you in completion of contact investigation in a timely manner. This is a "scratch sheet;" you are encouraged to check off duties/forms as each is completed.
- TUBERCULOSIS EPIDEMIOLOGICAL WORKSHEET (OHD 48-63, Modified)
The second form in the packet is the TUBERCULOSIS EPIDEMIOLOGICAL WORKSHEET (OHD 48-63, modified). This form is intended to make you aware of the degree of infectivity and to make your investigation easier and more complete. Identification of potential contacts (pages 2 - 4) lists four areas from which to identify contacts. Most clues are gained from interview with the index case. Sometimes two or three interviews might be necessary.
"Household contacts" is more appropriately "housing unit contacts." These potential contacts should be investigated for the period of infectiousness. If an index case was housed in the Disciplinary Segregation Unit, Intensive Management Unit or Special Management Unit for a significant period of time during infectivity, all inmates and staff in that area should be investigated as potential cases.
If a suspected case spends an extended period of time in an infirmary area before diagnosis, it is suggested that debilitated, immune-suppressed, or chronically ill inmates who are infirmary patients be tested in the first circle because if infected, these inmates are more likely to rapidly progress to active TB. If it is suspected that inmate or health care workers have not adhered to respiratory precautions, they should also be included in first circle testing.
"Employment" refers to that area where the index case spent the majority of his/her time. It may include work assignment, VT assignment, school. Special attention should be paid to closed, less ventilated areas like AA meetings, church, or offices. Close friends who share space on a regular basis, e.g., eating meals or attending functions together may need to be tested. Again, re-circulated air poses a significant increased risk.
"Other" is a catchall category and will help you think about other sources of potential contacts. Remember that children and the elderly have increased risk.
Contacts who have spent a significant amount of time in a closed environment with a case of pulmonary tuberculosis whose sputum is AFB-smear positive or who has a cavity on chest x-ray should be tested. This may include a tier or cellblock, teachers, VT instructors, chaplains, correctional officers (especially cell block officers), counselors and/or medical staff. Close friends of the inmate should also be tested. Visitors should be contacted if the inmate case reports significant coughing in the presence of the visitor. Special attention should be paid to visitors who are children.
Again, if a case of pulmonary tuberculosis is found to reside in a housing unit that has re-circulated airflow, all inmate residents and staff of this unit should be screened.
When you finish this worksheet, you should have your first circle of potential contacts. Enter each name on the TB CONTACT INVESTIGATION RECORD.
ODOC Health Service requires at least 10 persons be included in first circle testing.
- CONTACT INVESTIGATION RECORD
The CONTACT INVESTIGATION RECORD is used to record application and result of TB screening tests. To make it easier, use a separate CONTACT INVESTIGATION RECORD for incarcerated inmates, released inmates, staff and other persons.
Incarcerated inmates. The Group Living Captain can provide a list of past cellmates during the period of infectivity. Apply TB screening tests on inmates at your institution and contact other Health Service Managers so that screening tests can be applied on transferred inmates.
Released inmates. Inmates who have paroled and are potential cases should be contacted via their parole officer. Institution counselors have the addresses of parole offices. It is recommended that letters to released inmates should be sent to their parole officer to assure adequate follow-up. (see SAMPLE LETTER TO NON-INCARCERATED PERSON REGARDING EXPOSURE)
It is also recommended that telephone contact be made with county Public Health Department advising them of the possibility of released person's contact with an index case. A form letter is recommended as written follow-up. (see SAMPLE LETTER TO PUBLIC HEALTH DEPARTMENTS TO NOTIFY or alternatively The CONTACT FOLLOW-UP INTERJURISDICTIONAL TRANSFER NOTIFICATION form may be used.) Health Departments will then assume the responsibility for contact investigation. Form letters have been developed for this purpose.
Transferred inmates. It may be necessary to contact other correctional jurisdictions if the inmate/case was thought to be contagious during other incarcerations.
- TUBERCULOSIS FLOW SHEET (green sheet)
Begin an ODOC TUBERCULOSIS FLOW SHEET (green sheet) on all potential contacts housed at the institution where the index case was found and proceed as indicated by the algorithm flow. Record results on the CONTACT INVESTIGATION RECORD. Also record PPD or chest x-ray results of inmates housed in other institutions.
Repeat Mantoux Tests should be completed in two (2) months and not more than three (3) months as directed and recorded on the CONTACT INVESTIGATION RECORD.
C. Second Circle of Contacts for Mantoux Testing
If any in the first circle of contacts has a positive Mantoux skin test on initial or repeat Mantoux screening, assume that this conversion is due to exposure to the index case. A second circle of contacts should then be developed and tested.
When second circle testing is required, ODOC Health Services Central Office must be notified.
The second circle should include persons who have had frequent, but less intensive contact with the case than those in the first circle. This could include inmates who lived in the cell next to the inmate/case or persons who worked in close proximity to the inmate/case.
In general, medical personnel who had frequent but not close contact with the inmate/case would be in this category. Examples are outpatient workers, dental staff (unless included in the first circle), and clerical staff. Contact and repeat testing should be accomplished in the manner noted above.
D. Stopping the Investigation
When ten first circle contacts have been tested, and all demonstrate non-reactive screening Mantoux skin tests, testing of more remote contacts is usually unnecessary. If fewer than ten first circle contacts have been identified, re-thinking possibilities for follow-up screening is necessary.
E. Contact Management
Diagnostic interventions for Mantoux positive and negative contacts can be determined by using the TUBERCULOSIS FLOW SHEET (green sheet).
F. Suspected Drug-Resistant (MDR) Tuberculosis
This is serious. Contact Health Services Central Office and Epidemiology Section, Office of Health Status Monitoring, Oregon Health Division, regarding contact investigation.
INFECTION CONTROL
I. Transmission of tuberculous infection can be reduced by:
- early and adequate anti-tuberculosis drug therapy. Patients with pulmonary or laryngeal tuberculosis are most infectious before diagnosis and treatment. Generally, after the first several weeks of drug therapy, most tuberculosis patients become non-infectious, as shown by negative smears. Patients having only extra pulmonary tuberculosis usually do not transmit infection to others.
- having the active case cover the nose and mouth when coughing, sneezing, laughing, singing etc. This may be assisted by the patient wearing an appropriate mask during movement or transport.
- adequate ventilation to outside open air, or recycled ventilation if passed through an adequate High Efficiency Particulate Air (HEPA) filter.
- wearing of NIOSH-approved TB masks (e.g., N-95) by those persons exposed to contaminated air.
- ultraviolet light if airflow is such that MTB bacilli are closely exposed to this light. Since tuberculosis is transmitted through the air rather than by fomites or direct contact, disposal of personal items, eating utensils, etc., and washing walls are unnecessary.
Precautions to prevent airborne transmission of tubercle bacilli are particularly important during and immediately following procedures which stimulate coughing, e.g., sputum collection, sputum induction, bronchoscopy and aerosolized pentamidine treatments. Such procedures should be carried out in rooms or booths with negative air pressure in relation to adjacent rooms or hallways, with air exhausted directly to the outside and away from intake sources if the person is suspected or known to have TB. If sputum collection is desired in facilities where specially designated rooms are not available, patients should be taken outside the building to produce sputum.
All patients with HIV infection and undiagnosed pulmonary disease should be suspected of having tuberculosis, and appropriate precautions to prevent airborne transmission should be taken until tuberculosis is diagnosed and treated or ruled out.
II. MTB respiratory isolation requires:
- negative air pressure rooms, with 6-12 air exchanges an hour vented to outside air, or re-circulated through a HEPA filter, or with air flow directed over appropriate UV light source.
- NIOSH-approved mask for TB (rated N-95), worn by any persons entering respiratory isolation room. The staff should all have been instructed in appropriate fitting and fit testing of these masks.
- Surgical masks to stop droplet aerosolization should be worn by the patient whenever s/he is out of the respiratory isolation room. Patients should not be given N-95 or HEPA masks.
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| Quality Assurance |
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It is recommended that the quality of TB related services be evaluated periodically.
For example, the TB Coordinator or TB Practitioner may wish to evaluate TB screening, Application and Reading of the PPD Mantoux Test, Treatment of Latent TB Infection, Management of Active TB Disease or TB Infection Control.
Sample Qualify Assurance forms are included in this protocol.
Active TB Disease Form
PPD Mantoux Application & Reading form
TB Infection Control-General form
TB Screening form
Treatment of Latent TB Infection form
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