Montana Administrative Code

37.115.904 SHOWERS (REPEALED) Authorizing statute(s): 50-53-103, MCA Implementing statute(s): 50-53-101, 50-53-102, 50-53-103, 50-53-104, 50-53-106, 50-53-107, MCA History: NEW, 2010 MAR p. 80, Eff. 1/15/10; REP, 2011 MAR p. 2657, Eff. 12/9/11.

37.115.905 BABY CHANGING TABLES (REPEALED) Authorizing statute(s): 50-53-103, MCA IMP, 50-53-101, 50-53-102, 50-53-103, 50-53-104, 50-53-106, 50-53-107, MCA Implementing statute(s): 2010 MAR p. 80, Eff. 1/15/10 History: AMD, 2011 MAR p. 2657, Eff. 12/9/11; REP, 2018 MAR p. 2216, …

37.116.101 DEFINITIONS For the purpose of this chapter, the following definitions apply: "Alternative container" means any receptacle or enclosure which: is of sufficient strength to be used to hold and to transport a dead human body; is able to be closed to provide a complete co…

37.116.102 DEATH OF A PERSON WITH AN INFECTIOUS DISEASE AND NOTIFICATION OF MORTUARY When a person dies, the person's health care provider, the local coroner who certifies the death, or, if the death occurs in a health care facility, a facility staff member designated by the faci…

37.116.103 TRANSPORTATION OF DEAD HUMAN BODIES The body of a person who died or is suspected by the person's health care provider, the coroner, or the local health officer of dying with a disease listed in ARM 37.116.102(3) may not be transported unless enclosed in a hermetically…

37.116.104 PROHIBITIONS A disinterred human body of a person who died with a disease listed in ARM 37.116.102(3) may not be accepted for transportation by a common carrier or private conveyer unless the remains are enclosed in an alternative container approved by the local health…

37.116.105 EXCEPTIONS The department or a local health officer may grant an exception to the provisions of: ARM 37.116.103(2) or 37.116.104(1) if such exception is requested prior to transportation of the dead human body and if such exception does not constitute a hazard to publi…

37.117.101 TOBACCO SETTLEMENT ACCOUNTS: PURPOSES AND USES The department will design and implement programs to prevent tobacco-related disease. The program will include, but will not be limited to, the following components: state and community interventions; health communication …

37.12.201 REGISTRATION Every person, firm or corporation operating or maintaining a laboratory in which body fluids, secretions or excretions are examined for the determination of the presence or absence of an infectious agent in the material examined or in the person or animal f…

37.12.205 APPROVAL Laboratories which, after inspection, are found to conform to the standards required by the department will be given a certificate of approval, and such laboratories will thereafter be designated as approved laboratories. Authorizing statute(s): 50-1-202, MCA I…

37.12.206 INSPECTIONS An authorized representative of the state laboratory shall make an annual inspection of all registered laboratories, and at such other times as he or the department may deem advisable. Authorizing statute(s): 50-1-202, MCA Implementing statute(s): 50-1-202, …

37.12.301 DEFINITIONS For the purpose of this subchapter: "Accuracy" means the degree of agreement between an observed value and an accepted reference value. "Analyte" means the substance or thing for which a water sample is analyzed to determine its presence or quantity. "Bachel…

37.12.304 LABORATORY LICENSURE: COVERAGE A laboratory that conducts analyses of water from public water supplies must meet the licensure requirements of these rules before the analyses or reports of the analyses may be accepted by the Department of Environmental Quality (DEQ) for…

37.12.305 PROCEDURE FOR LICENSURE Any laboratory not currently licensed but desiring licensure under this subchapter must: submit a completed application to the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box …

37.12.306 STANDARDS, INSPECTIONS, AND TESTS REQUIRED FOR LICENSURE In order to be licensed, a laboratory must: meet all of the applicable personnel, equipment, training, and facility requirements of this subchapter; at least once during the three-year term of its license, pass an…

37.12.310 LICENSURE FEES The following fees calculated on a flat fee yearly schedule, must be submitted to the department, under the circumstances noted, by laboratories conducting analyses of public water supplies. All licensure fees are due January 1 of each calendar year. New …

37.12.311 DURATION OF LICENSE A license granted to an in-state laboratory is for a three year period provided: all of the requirements of this subchapter continue to be met for the type of license granted; the laboratory completes annual questionnaires from the department designe…

37.12.312 LICENSE In the case of a laboratory applying for a license for the first time, the department may grant a conditional license to a laboratory that: is in compliance with all requirements for licensure but has not yet analyzed a second PE sample or does not have records …

37.12.313 RECIPROCITY The department may issue a license to an out-of-state laboratory to perform analyses for public drinking water systems in Montana provided that the laboratory: applies for licensure and is currently approved by the Environmental Protection Agency or the stat…

37.12.314 RESTRICTION OF LICENSE The department may downgrade a laboratory to provisional status and place conditions upon the license of a laboratory. The provisionally licensed laboratory must notify clients of its downgraded status in writing, on any applicable report. The dep…

37.12.315 REVOCATION OR DENIAL OF LICENSE The department may deny or revoke a license at any time that a laboratory is not in compliance with the requirements for licensure under this subchapter, including if the laboratory: fails to analyze and report results of at least two PE …

37.12.316 REISSUANCE OF LICENSE The department will issue a license to a laboratory whose license has been denied or revoked when the laboratory demonstrates to the department that all appropriate requirements listed in the EPA laboratory certification manual are satisfied and wh…

37.12.320 PROFICIENCY TESTING For a laboratory to become approved and to maintain approval for conducting analyses for an analyte or an interdependent analyte group by a specific method, the laboratory must, at its own expense, meet the proficiency testing requirements of this ru…

37.12.324 REQUIRED NOTIFICATION OF CHANGES Whenever a laboratory makes any change in personnel or equipment that has a material effect on the analysis of analytes, the laboratory must notify the department of that fact within 30 days after making the change, but prior to reportin…

37.12.325 REQUIRED NOTIFICATION OF CHANGE IN NAME A licensed laboratory that changes its name or business organizational status must report the change in writing to the department within 30 days of the change. Authorizing statute(s): 50-1-202, MCA Implementing statute(s): 50-1-20…

37.12.326 REQUIRED NOTIFICATION OF CHANGE IN LOCATION A licensed laboratory which intends to change its physical location shall notify the department 90 days prior to the relocation. The notification shall include the following: the full physical address of the new location; a no…

37.12.327 ACCESS TO FACILITY AND RECORDS A laboratory applying for a license and a licensed laboratory must allow department representatives access to the laboratory facility and public water supply records during laboratory operating hours to determine initial or continued compl…

37.12.330 BLIND SAMPLE TESTING The department may submit blind samples for analyses to a license applicant or a licensed laboratory in such a manner that the applicant or licensed laboratory is unaware of the identity of the submitter. The laboratory shall credit any charges for …

37.12.333 APPROVAL TO CONDUCT ANALYSES Analyses must be conducted using current EPA approved methods in accordance with the analytical requirements set forth in 40 CFR 141. Alternate analytical procedures are not permitted unless such procedures satisfy 40 CFR 141.27 and have bee…

37.12.336 QUALITY ASSURANCE A licensed laboratory must develop and implement a quality assurance program that is an integrated system of activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that its services meet its sta…

37.12.337 SAFETY A laboratory shall develop and maintain a safety program, including an education-based safety program, which meets the requirements of the Montana Safety Culture Act, Title 39, chapter 71, part 15, MCA, and ARM 24.30.2501 through 24.30.2558 implementing that act …

37.12.338 LABORATORY EQUIPMENT AND SUPPLIES A laboratory must have, at a minimum, the equipment and supplies necessary to perform an approved analytical method for each contaminant analysis for which approval is requested pursuant to ARM 37.12.305. The equipment and supplies must…

37.12.341 REPORTING REQUIREMENTS All results of samples collected from a public water supply system and accepted by the laboratory for analysis that exceed a maximum contaminant level (MCL) or that trigger additional actions under ARM Title 17, chapter 38, subchapter 2 must be pr…

37.12.342 REPORTING RESULTS FROM OTHER LABORATORIES If a laboratory refers testing to another laboratory, that referral laboratory must be licensed in Montana to perform drinking water analysis for that analyte and method. A laboratory that reports analyses performed by other lab…

37.12.345 CRITICAL ELEMENTS FOR CHEMISTRY LABORATORY LICENSURE In order to be licensed to perform chemical analyses, a laboratory must meet the standards contained in this rule. Analysts in training must be supervised by an experienced analyst who meets all of the requirements of…

37.12.346 CRITICAL ELEMENTS FOR MICROBIOLOGY LABORATORY LICENSURE In order to be licensed to perform microbiological analyses, a laboratory must meet the standards contained in this rule. Individual analysts must be approved by the state as meeting the standards of this rule in o…

37.12.401 LABORATORY FEES FOR ANALYSES Fees for clinical and environmental analyses performed by the laboratory of the department are set to reflect the actual costs of the tests and services provided. The department will maintain a list of all tests available from the lab and th…

37.12.601 CERTIFICATE FORM (REPEALED) Authorizing statute(s): 40-1-206, MCA Implementing statute(s): 40-1-203, 40-1-204, MCA History: NEW, 1983 MAR p. 1353, Eff. 9/30/83; TRANS, from DHES, 2001 MAR p. 2246; AMD, 2003 MAR p. 2442, Eff. 10/31/03; REP, 2023 MAR p. 180, Eff. 2/25/23.…

37.12.603 PROCEDURES (REPEALED) Authorizing statute(s): 40-1-206, MCA Implementing statute(s): 40-1-203, 40-1-204, 40-1-206, MCA History: NEW, 1983 MAR p. 1353, Eff. 9/30/83; TRANS, from DHES, 2001 MAR p. 2246; AMD, 2003 MAR p. 2880, Eff. 10/31/03; REP, 2023 MAR p. 180, Eff. 2/25…

37.12.608 EXEMPTIONS FROM REQUIREMENT FOR SEROLOGICAL TESTING (REPEALED) Authorizing statute(s): 40-1-206, MCA Implementing statute(s): 40-1-206, MCA History: NEW, 1983 MAR p. 1353, Eff. 9/30/83; TRANS, from DHES, 2001 MAR p. 2246; REP, 2023 MAR p. 180, Eff. 2/25/23.

37.12.801 APPROVED TESTS The approved tests shall include a standard serological test for syphilis, rubella immunity, and blood group including O, A, B, AB, and Rho(D) . Authorizing statute(s): Sec. 50-19-101, MCA Implementing statute(s): Sec. 50-19-101, MCA History: NEW, Eff. 1/…

37.12.802 APPROVED LABORATORY The required prenatal tests shall be done in a laboratory approved by the department of public health and human services. Authorizing statute(s): Sec. 50-19-104, MCA Implementing statute(s): Sec. 50-19-104, MCA History: NEW, Eff. 1/5/74; TRANS, from …

37.14.1001 SCOPE This subchapter establishes requirements for use of x-ray producing devices in the healing arts by a practitioner licensed by law to use or direct the use of such devices in the course of his professional practice or upon a prescription or other order lawfully is…

37.14.1002 DEFINITIONS As used in this subchapter: "Aluminum equivalent" means the thickness of aluminum affording the same attenuation, under specified conditions, as the material in question. "Diagnostic-type tube housing" means an x-ray tube housing so constructed that leakage…

37.14.1003 GENERAL SAFETY PROVISIONS Diagnostic x-ray systems, for use on humans, and their associated components certified pursuant to the federal diagnostic x-ray standard shall be maintained in compliance with applicable requirements of such standard as set forth in 21 CFR, ch…

37.14.1005 PROHIBITED USE No registrant shall operate or permit the operation of x-ray equipment unless the equipment and installations meet the applicable requirements of this chapter. Authorizing statute(s): Sec. 75-3-201, MCA Implementing statute(s): IMP, 75-3-202, MCA History…

37.14.1006 FLUOROSCOPIC INSTALLATIONS The equipment used in fluoroscopic installation shall be as follows: The tube housing shall be of a diagnostic type. During fluoroscopy and cinefluorography, the kV and the mA shall be continuously indicated. The source to skin distance shall…

37.14.101 POLICY Except as otherwise specifically provided, this chapter applies to all persons who receive, possess, use, transfer, own or acquire any source of radiation; provided, however, that nothing in these rules shall apply to any person to the extent such person is subje…

37.14.1010 DENTAL RADIOGRAPHIC INSTALLATIONS The equipment used in dental radiographic installations shall be as follows: The tube housing shall be of diagnostic type. Diaphragms or cones shall be used for collimating the useful beam and provide the same degree of protection as t…

37.14.1011 VETERINARY MEDICINE RADIOGRAPHIC INSTALLATIONS The equipment used in veterinary medicine radiographic installations shall be as follows: The tube housing shall be of diagnostic type. Diaphragms or cones shall be provided for collimating the useful beam to the area of c…