BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the adoption of New Rules I through III, the amendment of ARM 37.114.101, 37.114.105, 37.114.201, 37.114.203, 37.114.204, 37.114.301, 37.114.313, 37.114.314, 37.114.315, 37.114.501, 37.114.512, 37.114.515, 37.114.530, 37.114.531, 37.114.546, 37.114.552, 37.114.571, 37.114.583, 37.114.1001, 37.114.1002, 37.114.1005, 37.114.1006, 37.114.1015, and 37.114.1016, and the repeal of ARM 37.114.527 and 37.114.1010 pertaining to the periodic update of administrative rules related to the reporting and control of communicable disease

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NOTICE OF PUBLIC HEARING ON PROPOSED ADOPTION, AMENDMENT, AND REPEAL

 

TO: All Concerned Persons

 

            1. On February 23, 2017, at 1:30 p.m., the Department of Public Health and Human Services will hold a public hearing in the auditorium of the Department of Public Health and Human Services Building, 111 North Sanders, Helena, Montana, to consider the proposed adoption, amendment, and repeal of the above-stated rules.

 

2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact the Department of Public Health and Human Services no later than 5:00 p.m. on February 17, 2017, to advise us of the nature of the accommodation that you need. Please contact Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail [email protected].

 

3. The rules as proposed to be adopted provide as follows:

 

NEW RULE I OUTBREAK IN AN INSTITUTIONAL OR CONGREGATE SETTING (1) Infection control precautions must be employed until laboratory tests indicate what organism is responsible for the outbreak, after which, control measures must be taken which are specific for the organism in question.

 

AUTH: 50-1-202, 50-2-118, MCA

IMP: 50-1-202, 50-2-118, MCA

 

NEW RULE II ESCHERICHIA COLI ENTERITIS (SHIGA-TOXIN PRODUCING) (1) The local health officer or the department must ensure that a child attending day care or child care as defined in ARM 37.95.102 must be excluded from such care until diarrhea resolves and two stool cultures collected at least 24 hours apart, obtained at least 48 hours after antimicrobial therapy has been discontinued, are negative.

 

AUTH: 50-1-202, 50-2-118, MCA

IMP: 50-1-202, 50-2-118, MCA

 

            NEW RULE III TYPHOID FEVER (1) The local health officer or the department must ensure that a child attending child care in facilities defined in ARM 37.95.102 must be excluded from such care until diarrhea resolves and three stool cultures collected at least 24 hours apart, obtained at least 48 hours after antimicrobial therapy has been discontinued, are negative.

 

AUTH: 50-1-202, 50-2-118, MCA

IMP: 50-1-202, 50-2-118, MCA

 

4. The rules as proposed to be amended provide as follows, new matter underlined, deleted matter interlined:

 

            37.114.101 DEFINITIONS Unless otherwise indicated, the following definitions apply throughout this chapter:

            (1) remains the same.

            (2) "Clean" means to remove infectious agents and/or organic matter from surfaces on which and in which infectious agents and/or organic matter may be able to live and remain virulent, by scrubbing and washing as with hot water and soap or detergent.

            (3) remains the same, but is renumbered (2).

            (4) "Concurrent disinfection" means the use of a method which will destroy any harmful infectious agents present immediately after the discharge of infectious material from the body of an infected person, or after the soiling of articles with such infectious discharges before there is opportunity for any other contact with them.

            (5) and (6) remain the same, but are renumbered (3) and (4).

            (7) (5)  "Control of Communicable Diseases Manual" means the "Control of Communicable Diseases Manual, An Official Report of the American Public Health Association," (19th edition, 2008) 20th edition, 2015.

            (8) remains the same, but is renumbered (6).

            (7) "Directly observed therapy (DOT)" means the method whereby a trained health-care worker or another trained designated person watches a patient swallow each dose of antituberculosis medication and documents it.

(9) through (16) remain the same, but are renumbered (8) through (15).

            (17) (16)  "Infection control precautions" means those measures necessary to prevent the transmission of disease from an infected person to another person, taking into consideration the specific suspected or confirmed communicable disease and the specific circumstances of the case. The infection control precautions required for a case admitted to a hospital or other health care facility are those measures identified as isolation precautions applicable to the specific disease in the "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" adopted in ARM 37.114.105. The infection control precautions required for a case not admitted to a hospital or other health care facility are those measures identified as methods of control applicable to the specific disease in the "Control of Communicable Diseases Manual, An Official Report of the American Public Health Association" (19th edition, 2008) , 20th edition, 2015, adopted in ARM 37.114.105. Infection control precautions are required, as stated in this rule, whether or not the person is subject to isolation.

            (18) (17)  "Infectious agent" means an organism (including but not limited to virus, rickettsia, bacteria, fungus, protozoan, prion, or helminth) that is capable of producing an infection or infectious disease.

            (19) through (31) remain the same, but are renumbered (18) through (30).

            (32) (31) "Sexually Transmitted Diseases Treatment Guidelines, 2010 2015" means the guidelines published by the U.S. Centers for Disease Control and Prevention.

            (33) and (34) remain the same, but are renumbered (32) and (33).

 

AUTH:  50-1-202, 50-2-116, 50-17-103, MCA

IMP:  50-1-202, 50-17-103, 50-18-101, MCA

 

37.114.105 INCORPORATION BY REFERENCE (1) The department adopts and incorporates by reference the following publications:

            (a) The "Control of Communicable Diseases Manual, An Official Report of the American Public Health Association" (19th edition, 2008), 20th edition, 2015, which lists and specifies control measures for communicable diseases. A copy of this document may be obtained from the American Public Health Association, 800 I Street NW, Washington, DC 20001.

(b) The "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" published by the U.S. Centers for Disease Control and Prevention, which specifies precautions that should be taken to prevent transmission of communicable diseases for cases admitted to a hospital or other health care facility. A copy of this document is available from the Department of Public Health and Human Services, Public Health and Safety Division, Communicable Disease Epidemiology Section, 1400 Broadway, P.O. Box 202951, Helena, Montana 59620-2951, phone: (406) 444-0273.

            (c) The "Sexually Transmitted Diseases Treatment Guidelines, 2010" are published by the U.S. Centers for Disease Control and Prevention in the December 17, 2010, Morbidity and Mortality Weekly Report, volume 51, and specify the most currently accepted effective treatments for sexually transmitted diseases. A copy of this document is available from the Department of Public Health and Human Services, Public Health and Safety Division, HIV/STD Section, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951, phone: (406) 444-3565.

            (d) The "Food Code, 2013, Recommendations of the United States Public Health Service, Food and Drug Administration" published by the National Technical Information Service.

            (e) The Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis, published in Clinical Infectious Diseases, October 1, 2016.

            (f) The "Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis," which provide recommendations from the National Tuberculosis Controllers Association and the U.S. Centers for Disease Control and Prevention, published December 16, 2005.

            (2) To obtain, or for information on how to obtain, any document or publication incorporated by reference, contact the Department of Public Health and Human Services, Public Health and Safety Division, Communicable Disease Control and Prevention Bureau, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951, phone:  (406) 444-0919.

 

AUTH:  50-1-202, MCA

IMP:  50-1-202, MCA

 

            37.114.201 REPORTERS (1) With the exceptions noted in (3), and (4), and (5), any person, including, but not limited to a physician, dentist, nurse, medical examiner, other health care practitioner, administrator of a health care facility or laboratory, public or private school administrator, or laboratory professional who knows or has reason to believe that a case exists of a reportable disease or condition defined in ARM 37.114.203 must immediately report to the local health officer the information specified in ARM 37.114.205(1) and (2).

            (2) through (4) remain the same.

            (5) With the exception of diseases listed in ARM 37.114.204(1) and (2)(a), laboratories, with the consent of the local health officer, may utilize electronic laboratory reporting (ELR) to satisfy (1).

 

AUTH:  50-1-202, 50-17-103, 50-18-105, MCA

IMP:  50-1-202, 50-2-118, 50-17-103, 50-18-102, 50-18-106, MCA 

           

          37.114.203 REPORTABLE DISEASES AND CONDITIONS (1) The following communicable diseases and conditions are reportable:

            (a) AIDS, as defined by the Centers for Disease Control and Prevention, and HIV infection, as determined by a positive result from a test approved by the Federal Food and Drug Administration for the detection of HIV, including, but not limited to, antibody, antigen, and all HIV nucleic acid tests;

            (b) and (c) remain the same.

            (d) Arboviral Disease diseases, neuroinvasive and nonneuroinvasive (California serogroup, Chikungunya, Eastern equine encephalitis, Powassan, Saint Louis encephalitis, West Nile Vvirus, Western equine encephalitis, Zika virus infection);

            (e) remains the same.

            (f) Botulism (including infant, foodborne, other, and wound botulism);

            (g) remains the same.

            (h) Campylobacter Campylobacteriosis;

            (i) remains the same.

            (j) Chlamydial Chlamydia trachomatis infection;

            (k) Cholera;

            (l) through (q) remain the same.

            (r) Erlichiosis Ehrlichiosis;

            (s) remains the same.

            (t) Gastroenteritis outbreak;

            (u) through (x) remain the same, but are renumbered (t) through (w).

            (y) (x)  Hansen's disease (leprosy);

            (z) through (ac) remain the same, but are renumbered (y) through (ab).

            (ad) (ac)  Hepatitis C, acute, infection, past or present chronic;

            (ae) remains the same, but is renumbered (ad).

            (af) (ae)  Lead poisoning (blood levels ≥ than 5 five micrograms per deciliter (ug/dl) for children 13 years of age or younger);

            (ag) remains the same, but is renumbered (af).

            (ag) Leptospirosis;

            (ah) through (ap) remain the same.

            (aq) Poliomyelitis, paralytic or non-paralytic nonparalytic;

            (ar) remains the same.

            (as) Q-fever (acute and chronic);

            (at) remains the same.

            (au) Rickettsiosis (spotted fever);

            (av) and (aw) remain the same, but are renumbered (au) and (av).

            (ax) (aw)  Severe Aacute Rrespiratory Ssyndrome-associated Ccoronavirus (SARS-CoV) disease;

            (ay) and (az) remain the same, but are renumbered (ax) and (ay).

            (az) Spotted fever rickettsiosis;

            (ba) remains the same.

            (bb) Streptococcal toxic shock syndrome (STSS);

            (bc) through (be) remain the same.

            (bf) Toxic shock syndrome (TSS) (nonstreptococcal);

            (bg) remains the same.

            (bh) Trichinellosis (Ttrichinosis);

            (bi) through (bk) remain the same.

            (bl) Varicella (chickenpox);

            (bm) remains the same.

            (bn) Viral hemorrhagic fevers; and

            (bo) Yellow fever; and.

            (bp) Any unusual incident of unexplained illness or death in a human or animal with potential human health implications.

            (2) Also reportable is an outbreak of any communicable disease listed in the "Control of Communicable Diseases Manual, an Official Report of the American Public Health Association" (20th edition, 2015) in an institutional or congregate setting and any unusual incident of unexplained illness or death in a human or animal with potential human health implications.

 

 

AUTH:  50-1-202, 50-17-103, 50-18-105, 50-18-106, MCA

IMP:  50-1-202, 50-2-118, 50-17-103, 50-18-102, 50-18-106, MCA

 

            37.114.204 REPORTS AND REPORT DEADLINES (1) A local health officer must immediately report (within four hours) to the department by telephone the information cited in ARM 37.114.205(1) through (2) whenever a case of one of the following diseases is suspected or confirmed:

            (a) through (d) remain the same.

            (e) Severe Aacute Rrespiratory Ssyndrome-associated Ccoronavirus (SARS-CoV) disease;

            (f) through (h) remain the same.

            (2) A local health officer must transmit by telephone or secure electronic means to the department the information required by ARM 37.114.205(1) and (2) for each suspected or confirmed case of one of the following diseases, within the time limit noted for each:

            (a) Information about a case of one of the following diseases should be submitted within 24 hours by telephone after it is received by the local health officer:

            (i) an outbreak of a disease or condition specified in ARM 37.114.203;

            (ii) any unusual incident of illness or death in a human or animal with potential human health implications;

            (i) and (ii) remain the same, but are renumbered (iii) and (iv).

            (iii) Gastroenteritis outbreak;

            (iv) remains the same, but is renumbered (v).

            (v) Novel influenza A virus infection;

            (vi) through (viii) remain the same.

            (ix) Rubella; and

            (x) Syphilis; and.

            (xi) Yellow fever.

            (b) Information about a case of one of the following diseases should must be submitted within seven calendar days after it is received by the local health officer:

            (i) and (ii) remain the same.

            (iii) Arboviral Ddiseases, (neuroinvasive and non-neuroinvasive) (California serogroup, Chikungunya, Eastern equine encephalitis, Powassan, Saint Louis encephalitis, West Nile virus, Western equine encephalitis, Zika virus infection);

            (iv) remains the same.

            (v) Campylobacter enteritis Campylobacteriosis;

            (vi) and (vii) remain the same.

            (viii) Cholera;

            (viii) remains the same, but is renumbered (ix).

            (ix) (x)  Colorado Tick Fever tick fever;

            (x) remains the same, but is renumbered (xi).

            (xi) (xii)  Cyclosporioasis Cyclosporiasis;

            (xii) through (xv) remain the same, but are renumbered (xiii) through (xvi).

            (xvi) (xvii)  Hansen's disease (leprosy);

            (xvii) through (xx) remain the same, but are renumbered (xviii) through (xxi).

            (xxi) (xxii)  Hepatitis C, acute, infection past or present chronic;

            (xxii) (xxiii)  Lead poisoning (blood levels ≥ 5 five micrograms per deciliter (ug/dl) for children 13 years of age or younger);

            (xxiii) remains the same, but is renumbered (xxiv).

            (xxv) Leptospirosis;

            (xxiv) through (xxx) remain the same, but are renumbered (xxvi) through (xxxii).

            (xxxi) (xxxiii)  Q-fever (acute and chronic);

            (xxxii) Rickettsiosis (Spotted Fever);

            (xxxiii) and (xxxiv) remain the same, but are renumbered (xxxiv) and (xxxv).

            (xxxvi) Spotted fever rickettsiosis;

            (xxxv) remains the same, but is renumbered (xxxvii).

            (xxxvi) (xxxviii)  Streptococcal toxic shock syndrome (STSS);

            (xxxvii) and (xxxviii) remain the same, but are renumbered (xxxix) and (xl).

            (xxxix) (xli)  Toxic shock syndrome (non-streptococcal) (nonstreptococcal) (TSS);

            (xl) remains the same, but is renumbered (xlii).

            (xli) (xliii)  Trichinellosis (Ttrichinosis);

            (xlii) and (xliii) remain the same, but are renumbered (xliv) and (xlv).

            (xliv) (xlvi)  Varicella (chickenpox);

            (xlv) (xlvii)  Vibrio cholera infection (Ccholera); and

            (xlvi) (xlviii)  Vibriosis.; and

            (xlix) Yellow fever.

            (3) remains the same.

            (4) For any animal bite to a human by a species susceptible to rabies infection, the local health officer must report by secure electronic means to the department documentation of a rabies post-exposure prophylaxis recommendation and/or administration on a form provided by the department within seven calendar days of the recommendation or administration.

            (5) A laboratory that performs a blood lead analysis must submit to the department, by the 15th day following the month in which the test was performed, a copy of all blood lead analyses performed that month, including analyses in which lead was undetectable.

            (6) A laboratory that performs testing for respiratory syncytial virus (RSV) must submit to the department on a weekly basis, October 1 through June 1, a summary of the total number of RSV-specific antigen direct detection tests performed, the number of positive tests for each type, and the testing method (rapid or molecular testing) used for each specimen result on a form provided by the department.

            (7) (5)  A laboratory that performs testing associated with HIV infection must report:

            (a) all any test result or combination of test results that confirm indicate HIV infection,;

            (b) all CD4 T-lymphocyte test results with or without confirmed HIV infection unless it is known that the test was performed in association with a disease other than HIV infection or HIV-related illness, positive p24 antigen assays,;

            (c) HIV nucleic acid viral load tests, RNA or DNA, irrespective of results, positive results for qualitative nucleic acid tests for the detection of HIV infection; and (d) all test results for assays designed to assess HIV infection subtype and resistance to antiretroviral drugs, including nucleotide sequences, in a format designated by the department.

 

AUTH:  50-1-202, 50-17-103, 50-18-105, MCA

IMP:  50-1-202, 50-17-103, 50-18-102, 50-18-106, MCA

 

            37.114.301 SENSITIVE OCCUPATIONS (1) remains the same.

            (2) No infectious person may engage in any occupation or activity involving the preparation, serving, or handling of food, including milk, to be consumed by others than his/her their immediate family, until a local health officer determines him/her them to be free of the infectious agent or unlikely to transmit the infectious agent due to the nature of his/her their particular work.

            (3)  Persons involved in food preparation, serving, or handling of food may be subject to additional restrictions as specified in: "Food Code, 2013, Recommendations of the United States Public Health Service, Food and Drug Administration" published by National Technical Information Service, Publication PB2013-110462, ISBN 978-1-935239-02-4, November 3, 2013.

            (4)  Persons attending or residing in congregate settings may be subject to additional restrictions and exclusions to prevent further transmission as determined by the local health authority.

 

AUTH:  50-1-202, MCA

IMP:  50-1-202, MCA

 

          37.114.313 CONFIRMATION OF DISEASE (1) Subject to the limitation in (2), if a local health officer receives information about a case of any of the following diseases, the officer must ensure that a specimen from the case is submitted to the department, when possible, which will be analyzed to confirm the existence or absence of the disease in question, or for use in surveillance:

            (a) remains the same.

            (b) Arboviral diseases, neuroinvasive and non-neuroinvasive (California serogroup, Chikungunya, Eastern equine encephalitis, Powassan, Saint Louis encephalitis, West Nile virus, Western equine encephalitis, Zika virus infection);

            (b) through (h) remain the same, but are renumbered (c) through (i).

            (i) Gastroenteritis outbreak;

            (j) through (q) remain the same.

            (r) Pertussis;

            (s) through (w) remain the same, but are renumbered (r) through (v).

            (x) (w)  Severe Aacute Rrespiratory Ssyndrome-associated Ccoronavirus (SARS-CoV) disease;

            (y) through (ac) remain the same, but are renumbered (x) through (ab).

            (ac) Tularemia;

            (ad) remains the same.

            (ae) Vancomycin-intermediate Sstaphylococcus aureus (VISA);

            (af) Vancomycin-resistant Sstaphylococcus aureus (VRSA); and

            (ag) remains the same.

            (2) In the event of an outbreak of an arboviral disease, gastroenteritis, influenza, measles, or pertussis, analysis of specimens from each case is unnecessary after must be submitted until a representative sample has been reached the disease organism is as determined by the department.

            (3) A laboratory professional or any other person in possession of a specimen from a case of a disease listed in (1)(a) through (af) (ag) must submit the specimen to the department upon request.

            (4) remains the same.   

AUTH:  50-1-202, 50-1-204, MCA

IMP:  50-1-202, 50-1-204, MCA

 

            37.114.314 INVESTIGATION OF A CASE (1) remains the same.

            (2) If the local health officer finds that the nature of the disease and the circumstances of the case or outbreak warrant such action, the local health officer must:

            (a) and (b) remain the same.

            (c) take appropriate steps, as outlined in the "Control of Communicable Diseases Manual, An Official Report of the American Public Health Association" (19th edition, 2008 20th edition, 2015), to prevent or control the transmission of disease; and

            (d) and (3) remain the same.

 

AUTH:  50-1-202, 50-2-118, 50-17-103, 50-18-105, MCA

IMP:  50-1-202, 50-2-118, 50-17-103, 50-17-105, 50-18-102, 50-18-107, 50-18-108, MCA

 

            37.114.315 POTENTIAL OUTBREAKS (1) Whenever a communicable disease listed in ARM 37.114.204(1) 37.114.203, is reported or whenever any other communicable disease listed in or the "Control of Communicable Diseases Manual, An Official Report of the American Public Health Association" (19th edition, 2008) (20th edition, 2015), or other communicable disease which that constitutes a threat to the health of the public, becomes so prevalent as to endanger an area outside of the jurisdiction where it first occurred, the local health officer of the jurisdictional area in which the disease occurs must notify and cooperate with the department to control the transmission of the disease in question.

 

AUTH:  50-1-202, MCA

IMP:  50-1-202, 50-2-118, MCA

 

            37.114.501 MINIMAL CONTROL MEASURES (1) The department, except as otherwise provided in this subchapter, adopts and incorporates by reference the control measures in the "Control of Communicable Diseases Manual, An Official Report of the American Public Health Association" (19th edition, 2008) (20th edition, 2015). Unless a particular control measure specifies who is responsible, the local health officer or the authorized representative of a local health officer must:

            (a) and (b) remain the same.

 

AUTH:  50-1-202, 50-2-116, 50-2-118, MCA

IMP:  50-1-202, 50-2-116, 50-2-118, MCA

 

            37.114.512 CHANCROID (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Treatment Guidelines, 2010 2015" are followed.

 

AUTH:  50-1-202, 50-2-118, 50-18-105, MCA

IMP:  50-1-202, 50-2-118, 50-18-102, MCA

 

            37.114.515 CHLAMYDIAL INFECTION (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Treatment Guidelines, 2010 2015" are followed.

            (2) remains the same.

 

AUTH:  50-1-202, 50-2-118, 50-18-105, MCA

IMP:  50-1-202, 50-2-118, 50-18-102, 50-18-107, MCA

 

            37.114.530 GONORRHEA (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Treatment Guidelines, 2010 2015" are followed.

            (2) remains the same.

 

AUTH:  50-1-202, 50-2-118, 50-18-105, MCA

IMP:  50-1-202, 50-2-118, 50-18-102, 50-18-107, MCA

 

            37.114.531 GRANULOMA INGUINALE (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Treatment Guidelines, 2010 2015" are followed.

 

AUTH:  50-1-202, 50-2-118, 50-18-105, MCA

IMP:  50-1-202, 50-2-118, 50-18-102, MCA

          37.114.546 LEAD POISONING: ELEVATED BLOOD LEAD LEVELS IN CHILDREN (1) An elevated blood lead level is defined as being greater than or equal to 5 micrograms per deciliter (ug/dl) in children 13 years of age or younger. If the blood lead level was determined by capillary blood method, then the test result must be confirmed by venous method as soon as possible. The elevated blood lead level of concern is based on 2012 guidance from the Centers for Disease Control and Prevention (CDC). A copy of this document is available from the Department of Public Health and Human Services, Public Health and Safety Division, Communicable Disease Epidemiology Section, 1400 Broadway, P.O. Box 202951, Helena, Montana 59620-2951, telephone (406) 444-0273. The health officer must gather information about the circumstances and nature of the exposure using forms developed by the department.

            (2) In the case of an elevated venous level, the health care provider must retest the blood at intervals recommended by (CDC), until two consecutive tests taken at least two months apart show a level of less than 5 ug/dl. The local health officer must ensure that the following actions are performed when a blood lead level ≥ five micrograms per deciliter is reported. The health officer or health-care provider must provide:

(a) counseling about health consequences of lead poisoning;

(b) information about ways to eliminate lead exposure; and

           (c) referral of the case and household members potentially at risk of exposure to a health-care provider for additional follow-up and blood-lead testing as appropriate.

           (3) The department adopts and incorporates by reference the recommendations for blood lead testing intervals for children with elevated venous levels published in the May 2012 MMWR announcement cited above, the CDC's manual "Screening Young Children for Lead Poisoning: Guidance for State and Local Public Health Officials", and the March 2002 CDC manual ″Managing Elevated Blood Lead Levels Among Young Children: Recommendations from the Advisory Committee on Childhood Lead Poisoning Prevention,″ which contains guidance for identifying children with dangerous blood lead levels and intervening to protect them. A copy of this document is available from the Department of Public Health and Human Services, Public Health and Safety Division, Communicable Disease Epidemiology Section, 1400 Broadway, P.O. Box 202951, Helena, Montana 59620-2951, telephone (406) 444-0273. 

 

AUTH:  50-1-202, MCA

IMP:  50-1-202, MCA

 

            37.114.552 LYMPHOGRANULOMA VENEREUM (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Treatment Guidelines, 2010 2015" are followed.

 

AUTH:  50-1-202, 50-2-118, 50-18-105, MCA

IMP:  50-1-202, 50-2-118, 50-18-102, MCA

 

          37.114.571 RABIES EXPOSURE (1) Control measures outlined in the Control of Communicable Diseases Manual must be applied for confirmed or suspected exposures to a human by a species susceptible to rabies infection.

            (2) remains the same.

            (3) As soon as possible, after investigating a report of possible rabies exposure, the local health officer must inform the exposed person or the individual responsible for the exposed person if that person is a minor, whether or not treatment is recommended to prevent rabies and provide a referral to a health care provider.

            (4) Whenever the circumstances involve a dog, cat, or ferret, the local health officer must either:

            (a) arrange for the animal to be observed for signs of illness during a ten-day quarantine period at an animal shelter, veterinary facility, or other adequate facility, and ensure that any illness in the animal during the confinement or before release is evaluated by a veterinarian for signs suggestive of rabies; or and

            (b) if the symptoms observed are consistent with rabies, order the animal euthanized and the head sent to the Department of Livestock's diagnostic laboratory at in Bozeman for rabies analysis. The local health officer may also order an animal euthanized subsequent to isolation, and the brain analyzed.

 

AUTH:  50-1-202, 50-2-118, MCA

IMP:  50-1-202, 50-2-118, MCA  

             37.114.583 SYPHILIS (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Treatment Guidelines, 2010 2015" are followed.

 

AUTH:  50-1-202, 50-2-118, 50-18-105, MCA

IMP:  50-1-202, 50-2-118, 50-18-102, 50-18-107, MCA

 

            37.114.1001 TUBERCULOSIS DIAGNOSIS (1) The procedure and tests needed to diagnose whether or not an individual is infected with tuberculosis or has it in its communicable state, taking into account that person's particular history, are those contained in "Diagnostic Standards and Classification of Tuberculosis and Other Mycobacterial Diseases", a 1986 publication of the American thoracic society (ATS). A case of active tuberculosis disease exists if the case meets the laboratory or clinical criteria in (2) or (3).

(2) Examination of body tissues or secretions by microscopy and culture by a laboratory is required to establish the diagnosis of tuberculosis. It is recommended that at least six sputa, gastrics, or urine be negative for M. tuberculosis to rule out active disease. The growth of a single colony of M. tuberculosis is diagnostic. Laboratory criteria for active tuberculosis diagnosis:

(a) isolation of M. tuberculosis complex from a clinical specimen;

(b) demonstration of M. tuberculosis complex from a clinical specimen by nucleic acid amplification test; or

            (c) demonstration of acid-fast bacilli in a clinical specimen when a culture has not been or cannot be obtained or is falsely negative or contaminated.

            (3) A tuberculin skin test shall include:

            (a) an intra-dermal injection of 0.0001 milligrams (five tuberculin units) of purified protein derivative in 0.10 cubic centimeters (cc) of sterile diluent; and

            (b) recordation of the size of the palpable induration in millimeters (mm) no less than 72 hours following injection.

            (i) A significant reaction is one in which the induration is not less than five mm.

(ii) An insignificant or negative reaction is one in which the induration is not present or, if present, is less than five mm. Clinical criteria for active tuberculosis diagnosis:

(a) usually a positive tuberculin skin test result or positive interferon gamma release assay for M. tuberculosis;

(b) other signs and symptoms compatible with tuberculosis are for example:  abnormal chest radiograph, abnormal chest computerized tomography scan or other chest imaging study, or clinical evidence of current disease;

(c) treatment with two or more antituberculosis medications; and

            (d) a completed diagnostic evaluation.

            (4) The department hereby adopts and incorporates by reference "Diagnostic Standards and Classification of Tuberculosis and Other Mycobacterial Diseases", a 1986 publication of the American Thoracic Society which specifies the diagnostic methodology appropriate for tuberculosis. A copy of the above publication may be obtained from the Department of Public Health and Human Services, Health Policy and Services Division, Communicable Disease Control and Prevention Bureau, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951, phone: (406)444-0273.

 

AUTH:  50-1-202, 50-17-103, 50-17-105, MCA

IMP:  50-1-202, 50-17-103, 50-17-105, MCA

 

            37.114.1002 TUBERCULOSIS: COMMUNICABLE STATE ACTIVE DISEASE (1) A person has communicable will be considered to have active tuberculosis if one of the following conditions exists: until either the diagnosis of active tuberculosis is ruled out or adequate treatment is completed as determined by the local health officer or the department.

            (a) laboratory examination of sputa, gastric washings, bronchial washings, or pulmonary tissue culture shows, in at least one sputum specimen, the presence of either acid-fast bacilli or Mycobacterium tuberculosis (M. tuberculosis).

            (b) a chest x-ray shows changes characteristic of tuberculosis; or

            (c) in the case of extrapulmonary tuberculosis, drainage from the extrapulmonary site is not being disposed of in accordance with infection control precautions.

            (2) A person diagnosed as having communicable tuberculosis will continue to be regarded as having communicable tuberculosis until:

            (a) a culture of the specimen which was positive for M. tuberculosis or acid-fast bacilli on a smear shows, in a manner acceptable to the department, either no bacterial growth or an organism other than M. tuberculosis, if the diagnosis was based on laboratory analysis of a sputum specimen;

            (b) a tuberculin skin test is negative (induration is less than five mm or absent altogether) and sputa or gastric specimens taken on three consecutive days are found negative for acid-fast bacilli, if the diagnosis was based on chest x-ray results;

            (c) anti-tuberculosis drugs are being administered and tests of sputa or respiratory secretion specimens taken on three consecutive days are negative for acid-fast bacilli; or

            (d) in the case of extrapulmonary tuberculosis, drainage from the extrapulmonary site is disposed of according to infection control precautions. When a person with active tuberculosis is an in-patient at a healthcare facility, either for diagnosis, acute care, or long-term care, the facility must notify the local health officer or department before the patient is discharged from their facility.

 

AUTH:  50-1-202, 50-17-103, MCA

IMP:  50-1-202, 50-17-103, MCA

 

            37.114.1005 ISOLATION OF CASE TESTING AND QUARANTINE OF CONTACTS (1) Isolation must be imposed upon a case of communicable active tuberculosis until the infected person patient is determined considered not able to transmit tuberculosis as determined by the department or local health officer and the department's tuberculosis program to be no longer communicable.

            (2) The department or local health officer or department's tuberculosis program may require contacts of a case to be tested for tuberculosis infection and disease.

            (3) No quarantine of contacts is required unless the contact is in a communicable state symptomatic for active tuberculosis disease and has not completed a diagnostic evaluation to rule out active tuberculosis disease.

 

AUTH:  50-1-202, 50-1-204, 50-2-118, 50-17-103, MCA

IMP:  50-1-202, 50-1-204, 50-2-118, 50-17-102, 50-17-103, 50-17-105, MCA

 

            37.114.1006 TREATMENT STANDARDS (1) It is the opinion of the department that medical treatment of tuberculosis, in order to meet currently acceptable medical standards, must be consistent with those standards contained in "Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children", a statement adopted by the American Thoracic Society Board of Directors in March, 1986, and recommended by the Centers for Disease Control. A copy of the ATS tuberculosis treatment standards is available from the Department of Public Health and Human Services, Health Policy and Services Division, Communicable Disease Control and Prevention Bureau, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951, phone: (406)444-0273. Treatment of drug-susceptible active tuberculosis must be consistent with the standards contained in the Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis, published in Clinical Infectious Diseases, October 1, 2016.

(2) For patients with multi-drug resistant tuberculosis or other findings beyond the scope of the above guidelines in (1), the opinion of a tuberculosis expert physician with experience in treating drug-resistant or medically complicated tuberculosis will be sought and approved by the local health officer and the department's tuberculosis program.

            (3) A person with active tuberculosis will be treated using directly observed therapy (DOT) until treatment is completed. The DOT plan will be approved by the local health officer and the department's tuberculosis program.

 

AUTH:  50-1-202, 50-17-103, MCA

IMP:  50-17-102, 50-17-105, 50-17-107, 50-17-108, 50-17-112, 50-17-113, MCA

 

            37.114.1015 CASE FOLLOW-UP, AND REPORTING, AND CONTACT INVESTIGATION (1) The local health officer must ensure that each case of active tuberculosis within his/her their jurisdiction obtains the follow-up tests, treatment, and monitoring recommended by the American Thoracic Society and the Centers for Disease Control in their joint statements "Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children", adopted March, 1986, and "Control of Tuberculosis", adopted March, 1983 in the Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis, published in Clinical Infectious Diseases, October 1, 2016.

            (2) The local health officer must submit a report to the department every three months documenting the course of treatment and treatment completion date of each reported active tuberculosis case within his/her jurisdiction.

            (3) The department hereby adopts and incorporates by reference the portions of the joint statements of the American Thoracic Society and the Centers for Disease Control entitled "Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children" (March, 1986) and "Control of Tuberculosis" (March, 1983), which specify the follow-up tests, treatment, and monitoring necessary to ensure adequate recovery from tuberculosis. A copy of each statement may be obtained from the Department of Public Health and Human Services, Health Policy Services Division, Communicable Disease Control and Prevention Bureau, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951, phone: (406)444-0273. The local health officer must ensure that a contact investigation is completed for each active case of tuberculosis considered able to transmit tuberculosis, following the "Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis," December 16, 2005, a publication from the National Tuberculosis Controllers Association and the U.S. Centers for Disease Control and Prevention.

            (4) The local health officer must submit reports to the department documenting the progress of the contact investigation and a final summary on forms provided by the department.

 

AUTH:  50-1-202, 50-17-103, MCA

IMP:  50-1-202, 50-17-102, 50-17-105, MCA

 

            37.114.1016 SUBMISSION OF A SPECIMENS OR CULTURE

            (1) Whenever a physician diagnoses a case of tuberculosis, s/he they must ensure that a specimen or culture from the tuberculosis case is sent to the department's microbiology public health laboratory for confirmation of the results, drug susceptibility testing, and genotyping.

            (2) Whenever a laboratory finds a specimen tests or culture is positive for M. tuberculosis or acid-fast bacilli, the laboratory must forward submit the specimen or culture to the department's microbiology public health laboratory for confirmation of the results, and drug susceptibility testing, and genotyping.

 

AUTH:  50-1-202, 50-17-103, MCA

IMP:  50-1-202, 50-17-102, 50-17-103, MCA

 

5. The department proposes to repeal the following rules:

 

            37.114.527 GASTROENTERITIS OUTBREAK found on page 37-28891 of the Administrative Rules of Montana.

 

AUTH: 50-1-202, 50-2-118, MCA

IMP: 50-1-202, 50-2-118, MCA

 

            37.114.1010 EMPLOYEE OF SCHOOL: DAY CARE FACILITY CARE PROVIDER found on page 37-29173 of the Administrative Rules of Montana.

 

AUTH:  50-1-202, 50-17-103, 52-2-735, MCA

IMP:  50-1-202, 50-17-103, 52-2-735, MCA

 

            6. STATEMENT OF REASONABLE NECESSITY

 

The Department of Public Health and Human Services (department) is proposing to adopt New Rules I through III, amend ARM 37.114.101, 37.114.105, 37.114.201, 37.114.203, 37.114.204, 37.114.301, 37.114.313, 37.114.314, 37.114.315, 37.114.501, 37.114.512, 37.114.515, 37.114.530, 37.114.531, 37.114.546, 37.114.552, 37.114.571, 37.114.583, 37.114.1001, 37.114.1002, 37.114.1005, 37.114.1006, 37.114.1015, and 37.114.1016, and repeal ARM 37.114.527 and 37.114.1010.

 

These proposed amendments are necessary in order to keep Montana communicable disease control administrative rules current with changing nationally notifiable disease surveillance investigation and control recommendations.  Updated core references reflect changing technologies and knowledge of improved disease specific control measures.

 

New Rule I

 

The department is proposing this new rule as part of a comprehensive effort to expand outbreak reporting at settings that are more likely to experience spread of infectious disease. The inclusion of this rule would allow health departments to better respond to infectious disease outbreaks and recommend appropriate control measures to stop the spread of illness.

 

New Rule II

 

The department is proposing this new rule to incorporate scientific best practices as recommended by the Committee on Infectious Diseases of the American Academy of Pediatrics to protect other child care attendees from STEC infection that is often readily transmitted and can cause severe illness.

 

New Rule III

 

The department is proposing this new rule to incorporate scientific best practices as recommended by the Committee on Infectious Diseases of American Academy of Pediatrics to protect other child care attendees from typhoid fever infection that is often readily transmitted and can cause severe illness.

 

ARM 37.114.101

 

The department is proposing to amend the definition subsection to remove unused terms, update referenced materials, address subjective terminology, and to incorporate new terminology.

 

ARM 37.114.105

 

The department is proposing to amend this rule by updating referenced documents and proposing a new reference regarding the "Food Code" to align communicable disease rules with existing food and consumer safety rules based upon the new reference. In addition, tuberculosis treatment and investigation references are being proposed.

 

ARM 37.114.201

 

The department is proposing to update this rule to more clearly allow use of electronic laboratory reporting as it relates to disease reporting at local jurisdictional levels.

 

ARM 37.114.203

 

The department is proposing to update this rule to align it with the nationally notifiable disease listing from a disease and terminology standpoint and to better define reportable diseases and outbreaks. In addition, mandatory laboratory reporting for respiratory syncytial virus is being deleted as two years of data revealed better methods for surveillance of this disease.

 

ARM 37.114.204

 

The department is proposing to update this rule to align with the nationally notifiable disease listing from a disease and terminology standpoint and to better define reportable events.

 

ARM 37.114.301

 

The department is proposing to update this rule to better encompass, define, and align terminology with newly referenced "Food Code" noted under proposed ARM 37.114.105.

 

ARM 37.114.313

 

The department is proposing to update this rule to align it with the nationally notifiable disease listing from a disease and terminology standpoint and to better define reportable events.

 

ARM 37.114.314

 

The department is proposing to update the referenced documents.

 

ARM 37.114.315

 

The department is proposing to update the referenced documents and clarify language.

 

ARM 37.114.501

 

The department is proposing to update the referenced documents.

 

ARM 37.114.512

 

The department is proposing to update the referenced documents.

 

ARM 37.114.515

 

The department is proposing to update the referenced documents and terminology.

 

ARM 37.114.527

 

The department is proposing to repeal this rule as part of a larger comprehensive effort to better define outbreaks and resulting control measures. It was determined to be unnecessary and redundant due to how other newly referenced documents, such as the "Food Code," and other areas of the rules were adapted.

 

ARM 37.114.530

 

The department is proposing to update the referenced documents.

 

ARM 37.114.531

 

The department is proposing to update the referenced documents.

 

ARM 37.114.546

 

The department is proposing to amend this rule to align it with national changes in case definitions in order to encompass all elevated blood levels including adults as opposed to previous language only encompassing children. Further, the blood-lead level that triggers control measures has changed at the national level and the change reflects that. In addition, the control measure language is less prescriptive and defers to the department for associated forms to drive mitigation actions.

 

ARM 37.114.552

 

The department is proposing to update the referenced documents.

 

ARM 37.114.571

 

Minor formatting changes were made to clarify requirements for observation and animal testing.

 

ARM 37.114.583

 

The department is proposing to update the referenced documents.

 

ARM 37.114.1001

 

The department is proposing to amend this rule to align it with nationally notifiable disease case definitions.

 

ARM 37.114.1002

 

The department is proposing to amend this rule to align it with existing national guidelines regarding communicability when they exist and to provide needed flexibility for assessment of communicability of each patient on a case-by-case basis in the absence of specific national guidelines.  Language is being proposed to require notification of discharge of active or presumptively active tuberculosis cases to the local health officer or department to ensure the necessary continuity of care and protection of the public.

 

ARM 37.114.1005

 

The department is proposing to amend this rule to appropriately reflect that all active cases of tuberculosis will be assessed for ability to transmit tuberculosis and will be isolated until determined to be noncommunicable.  Language is being proposed on the quarantine of tuberculosis contacts to clarify that contacts do not need to be quarantined unless symptomatic for active disease and an evaluation is pending.

 

ARM 37.114.1006

 

The department is proposing to amend this rule to update the reference to national guidelines for the treatment of tuberculosis and to provide a mechanism for addressing treatment for situations that fall outside of referenced guidelines.  The proposed amendment also requires treatment for all persons with active tuberculosis to receive therapy using directly observed therapy which is the current standard of care nationwide.

 

ARM 37.114.1010

 

The department is proposing to repeal this rule because the U.S. Centers for Disease Control and Prevention recommends that only high-risk groups are screened for tuberculosis and the practice of screening low-risk groups should be discontinued.  Due to limitations of existing diagnostic tests for tuberculosis infection, when low-risk persons are tested, many results are falsely positive, which causes unintended consequences and diverts resources from higher-priority activities.

 

ARM 37.114.1015

 

The department is proposing to amend this rule to update references and to clarify the processes associated with implemented control measures.

 

ARM 37.114.1016

 

The department is proposing to amend this rule to clarify the language associated with the submission of required diagnostically associated specimens and cultures.

 

Fiscal Impact

 

The department anticipates no fiscal impact regarding the proposed rulemaking. 

 

The proposed rulemaking is estimated to affect: 58 local health jurisdictions (tribal/county), 46 Critical Access Hospitals, 14 Inpatient Hospitals, 3 outpatient hospitals, 84 laboratories, 7,304 physicians, and 2,109 mid-level practitioners.

 

            7. The department intends to apply these rule actions retroactively to July 1, 2016. A retroactive application of the proposed rule actions do not result in a negative impact to any affected party.

 

            8. Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to: Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail [email protected], and must be received no later than 5:00 p.m., March 3, 2017.

 

9. The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

10. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency.  Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 8 above or may be made by completing a request form at any rules hearing held by the department.

 

11. An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register.  The Secretary of State strives to make the electronic copy of the notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered.  In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

 

12. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

13. With regard to the requirements of 2-4-111, MCA, the department has determined that the adoption, amendment, and repeal of the above-referenced rules will not significantly and directly impact small businesses.

 

14. Section 53-6-196, MCA, requires that the department, when adopting by rule proposed changes in the delivery of services funded with Medicaid monies, make a determination of whether the principal reasons and rationale for the rule can be assessed by performance-based measures and, if the requirement is applicable, the method of such measurement. The statute provides that the requirement is not applicable if the rule is for the implementation of rate increases or of federal law.

 

The department has determined that the proposed program changes presented in this notice are not appropriate for performance-based measurement and therefore are not subject to the performance-based measures requirement of 53-6-196, MCA.

 

 

 

/s/ Nicholas Domitrovich                             /s/ Sheila Hogan                                         

Nicholas Domitrovich, Attorney                 Sheila Hogan, Director

Rule Reviewer                                           Public Health and Human Services

 

 

Certified to the Secretary of State January 23, 2017.