Peggy Leslie-Smith, RN EMPLOYEE HEALTH DIRECTOR - AVERA TRAINING CONTENT 1. South Dakota Regulations 2. Iowa Regulations 3. Minnesota Regulations 4. Interferon Gamma Release Assay (IGRA)Testing 1
SOUTH DAKOTA 44:75:04:09 Tuberculin Screening requirements Each facility shall develop criteria to screen healthcare workers for Mycobacterium tuberculosis (TB) based on the guidelines issued by Centers for Disease Control and Prevention. Each facility shall establish policies and procedures for conducting Mycobacterium tuberculosis risk assessment that include the key components of responsibility, surveillance, containment, and education. The frequency of repeat screening shall depend upon annual risk assessments conducted by the facility. 2
TUBERCULIN SCREENING REQUIREMENTS FOR HEALTHCARE WORKERS ARE AS FOLLOWS: (1) Each new healthcare worker shall receive the two-step method of tuberculin skin test or a TB blood assay test to establish a baseline within 14 days of employment. Any two documented tuberculin skin tests completed within a 12 month period prior to the date of employment can be considered a two-step or one TB blood assay test completed within a 12 month period prior to the date of employment can be considered an adequate baseline test. Skin testing or TB blood assay tests are not necessary if a new employee transfers from one licensed healthcare facility to another licensed healthcare facility within the state if the facility received documentation of the last skin or blood assay TB testing completed within the prior 12 months. Skin testing or TB blood assay test are not necessary if documentation is provided of a previous positive reaction to either test. Any new healthcare worker who has a newly recognized positive reaction to the skin test or TB blood assay test shall have a medical evaluation and a chest X-ray to determine the presence or absence of the active disease; SOUTH DAKOTA (2) A new healthcare worker who provides documentation of a positive reaction to the tuberculin skin test or TB blood assay test shall have a medical evaluation and chest X-ray to determine the presence or absence of the active disease; and 3
SOUTH DAKOTA (3) Each healthcare worker with a history of a positive reaction to the tuberculin skin test or TB blood assay shall be evaluated annually by a physician, physician assistant, nurse practitioner, clinical nurse specialist, or a nurse and a record maintained of the presence or absence of symptoms of Mycobacterium tuberculosis. If this evaluation results in suspicion of active tuberculosis, the person shall be referred for further medical evaluation to confirm the presence or absence of tuberculosis. Source: 42 SDR 51, effective October 13, 2015. IOWA 481 59.5(135B,135C) Baseline TB screening procedures for health care facilities and hospitals. All HCWs shall receive baseline TB screening upon hire. Baseline TB screening consists of two components: (1) assessing for current symptoms of active TB disease and (2) using a two-step TST or a single IGRA to test for infection with M. tuberculosis. 4
IOWA HCW may begin working with patients or residents after a negative TB symptom screen (i.e., no symptoms of active TB disease) and a negative TST (i.e., first step) or negative IGRA. The second TST may be performed after the HCW starts working with patients or residents. IOWA - POSITIVE REACTOR An HCW with a new positive test result for M. tuberculosis infection (i.e., TST or IGRA) shall receive one chest radiograph result to exclude TB disease. Repeat radiographs are not needed unless symptoms or signs of TB disease develop or unless recommended by a clinician. Treatment for LTBI should be considered in accordance with CDC guidelines. 5
IOWA PAST POSITIVE HCW with documentation of past positive test results (i.e., TST or IGRA) an documentation of the results of a chest radiograph indicating no active disease, dated after the date of the positive TST or IGRA test result, does not need another chest radiograph at the time of hire. IOWA - BCG Previous BCG vaccination is not a contraindication to having an IGRA, a TST or two-step skin testing administered. HCWs with previous BCG vaccination should receive baseline and serial testing in the same manner as those without BCG vaccination. Evaluation of TST reactions in persons vaccinated with BCG should be interpreted using the same criteria for those not BCG-vaccinated. An HCW s history of BCG vaccination should be disregarded when administering and interpreting TST results. Prior BCG vaccination does not cause a false-positive IGRA test result. [ARC 0484C, IAB 12/12/12, effective 1/16/13] 6
IOWA - TWO STEP A second TST is not needed if the HCW has a documented TST result from any time during the previous 12 months. If a newly employed HCW has had a documented negative TST result within the previous 12 months, a single TST can be administered in the new setting. This additional TST represents the second stage of two-step testing. The second test decreases the possibility that boosting on later testing will lead to incorrect suspicion of transmission of M. tuberculosis in the setting. IOWA POSITIVE REACTORS Health care facilities or hospitals classified as medium risk. HCWs with a baseline positive or new positive test result for M. tuberculosis infection or documentation of previous treatment for LTBI or TB disease shall receive one chest radiograph result to exclude TB disease. Instead of participating in serial testing, HCWs should receive a symptom screen annually. This screen should be accomplished by educating HCWs about symptoms of TB disease and instructing HCWs to report any such symptoms immediately to the occupational health unit. Treatment for LTBI should be considered in accordance with CDC guidelines. 7
MINNESOTA Regulations for Tuberculosis Control in Minnesota Health Care Settings. Baseline TB screening consists of three components: 1. Assessing for current symptoms of active TB disease, 2. Assessing TB history, and 3. Testing for the presence of infection with Mycobacterium tuberculosis by administering either a two-step TST or single IGRA. MINNESOTA - WORKING WITH PATIENTS An employee may begin working with patients after a negative TB symptom screen (i.e., no symptoms of active TB disease) and a negative IGRA or TST (i.e., first step) dated within 90 days before hire. The second TST may be performed after the HCW starts working with patients. 8
MINNESOTA GENERAL PRINCIPLES TST documentation should include the date of the test (i.e., month, day, year), the number of millimeters of induration (if no induration, document 0 mm) and interpretation (i.e., positive or negative). MINNESOTA - IGRA IGRA documentation should include the date of the test (i.e., month, day, year), the qualitative results (i.e., positive, negative, indeterminate or borderline) and the quantitative assay (i.e., Nil, TB and Mitogen concentrations or spot counts). Indeterminate or borderline results indicate an uncertain likelihood of M. tuberculosis infection and should be further evaluated by a physician. 9
MINNESOTA - BCG Disregard a HCW s history of BCG vaccination when administering and interpreting a TST. MINNESOTA - POSITIVE REACTORS Before the HCW has direct patient contact, the following should be documented in their record: 1. Test result, 2. Assessment for current TB symptoms, 3. Chest X-ray to rule out infectious TB disease. The chest X-ray should be done after the date of the positive TST or IGRA; however, a chest X-ray done within the three months prior to the TST/IGRA is acceptable, provided that the HCW has not been exposed to infectious TB disease since the chest X-ray was done. If infectious TB disease is ruled out, additional chest X-rays are not needed unless the HCW develops symptoms of active TB disease or a clinician recommends a repeat chest X-ray, 10
MINNESOTA 4. If the chest X-ray is done at the time of hire because documentation of a previous film was not available, a medical evaluation to rule out infectious TB disease should be done. No medical evaluation is required if HCW already has a chest X-ray dated after documented positive TST or IGRA. HCWs who work in medium-risk settings should be assessed for current TB symptoms on an annual basis and instructed to seek medical evaluation if TB symptoms develop at any time. INTERFERON-GAMMA RELEASE ASSAYS(IGRAS) Interferon-Gamma Release Assays (IGRAs) are whole-blood tests that can aid in diagnosing Mycobacterium tuberculosis infection. They do not help differentiate latent tuberculosis infection (LTBI) from tuberculosis disease. 11
IGRA Two IGRAs that have been approved by the U.S. Food and Drug Administration (FDA) are commercially available in the U.S: QuantiFERON -TB Gold In-Tube test (QFT-GIT); T-SPOT.TB test (T-Spot) HOW IT WORKS IGRAs measure a person s immune reactivity to M. tuberculosis. White blood cells from most persons that have been infected with M. tuberculosis will release interferon-gamma (IFN-g) when mixed with antigens derived from M. tuberculosis. 12
ADVANTAGES Requires a single patient visit to conduct the test. Results can be available within 24 hours. Does not boost responses measured by subsequent tests. Is not subjected to reader bias. Prior BCG (bacille Calmette-Guérin) vaccination does not cause a false-positive IGRA test result. DISADVANTAGES Errors in collecting or transporting blood specimens Blood samples must be processed within 8-30 hours after collection. Limited data on the use of IGRAs to predict who will progress to TB disease in the future. Tests may be expensive 13
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