reglab/statecodes huggingface dataset:
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.8 - RECORDS AND STATISTICS › Subchapter 37.8.16 - Institutions › Rule 37.8.1601 - INFORMATION RECORDED

Current through Register Vol. 13, July 5, 2024
(1) The records of
				all hospitals or other facilities or institutions for the care of persons must
				contain the following information: Full name of patient; address; sex; race;
				marital status; date of birth; age; occupation; birthplace; name of father;
				birthplace of father; maiden name of mother; birthplace of mother; disease at
				entrance; dates of entrance, discharge, removal, or death and other information
				required for the completion of birth, death and fetal death
				certificates.
(2) The requirements
				of Title 50, chapter 15, MCA, shall be literally enforced. Hospitals, other
				institutions, doctors offices, morticians, communal colonies and all other
				persons responsible for the generation or recording of vital statistics shall
				furnish such information or reports as required by Title 50, chapter 15, MCA,
				or the rules of the department.
Sec.
					 50-15-102,
					 MCA; IMP, Sec.
					 50-15-103,
					 50-15-108
					 and
					 50-15-109,
					 MCA;
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.8 - RECORDS AND STATISTICS › Subchapter 37.8.18 - Tumor Registry › Rule 37.8.1801 - REPORTABLE TUMORS

Current through Register Vol. 13, July 5, 2024
(1) The following
				tumors are designated as reportable:
(a)
				malignant neoplasm, with the exception of a basal or squamous carcinoma of the
				skin;
(b) skin cancer of the labia,
				vulva, penis or scrotum;
(c) benign
				tumor of the brain, including a:
(i)
				meningioma (cerebral meninges);
(ii) pinealoma (pineal gland); or
(iii) adenoma (pituitary gland);
(d) carcinoid tumor, whether
				malignant, benign or not otherwise specified (NOS).
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.8 - RECORDS AND STATISTICS › Subchapter 37.8.18 - Tumor Registry › Rule 37.8.1802 - REQUIRED RECORDS, INITIAL ADMISSION AND TREATMENT

Current through Register Vol. 13, July 5, 2024
(1) Whenever a hospital initially provides
				medical services to any patient relating to a tumor designated as reportable by
				ARM 37.8.1801, it must collect, record, and make available to the department
				the following information about that patient:
(a) name and current physical address of
				patient;
(b) patient's physical
				address at time of diagnosis;
(c)
				social security number;
(d) name
				of spouse, if any;
(e) phone
				number;
(f) race, Hispanic origin
				if applicable, sex, and marital status;
(g) age at diagnosis, place of birth, and
				month, day, and year of birth;
(h)
				name, address, and phone number of friend or relative to act as contact, plus
				relationship of that contact to patient;
(i) date and place of initial diagnosis;
(j) primary site of tumor (paired
				organ);
(k) sequence of primary
				tumors if more than one;
(l) other
				primary tumors;
(m) method of
				confirming diagnosis;
(n)
				histology, including dates, place, histologic type and slide number;
(o) summary staging, including whether in
				situ, localized, regional, distant or unstaged, with no information, or whether
				AJCC or TNM staging is utilized, and, if so, the findings of this staging;
(p) description of tumor and its
				spread, if any, including size in centimeters, number of positive nodes, number
				of nodes examined and site of distant metastases;
(q) procedures done to diagnose or stage
				tumors including dates, procedures, and results (such as physical exams,
				scopes, x-rays, scans, or lab tests);
(r) cumulative summary of all first course
				therapy directed at the subject tumor, including:
(i) date of therapy;
(ii) specific type of surgery or radiation
				therapy, if any, and details of chemical, hormonal, or other kinds of
				treatment; and
(iii) if no therapy
				given, reason for lack of therapy.
(s) status at time of latest recorded
				information, i.e., whether alive or dead, tumor in evidence, or recurring, or
				status unknown;
(t) if recurrence
				of tumor, date, type, and distant sites of first recurrence;
(u) names of physicians primarily and
				secondarily responsible for follow up;
(v) date of each follow up;
(w) if patient has died, date of death,
				place, cause, and whether autopsy performed;
(x) primary payer at diagnosis;
(y) usual occupation and industry; and
(z) tobacco and alcohol use
				history.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.8 - RECORDS AND STATISTICS › Subchapter 37.8.18 - Tumor Registry › Rule 37.8.1803 - REQUIRED RECORDS, FOLLOW UP

Current through Register Vol. 13, July 5, 2024
(1)
				Whenever a patient for whom information has been provided to the tumor registry
				is admitted to the hospital providing the information on an inpatient or
				outpatient basis for further treatment related to the tumor for which original
				registration in the tumor registry was made, the hospital must keep on file the
				following information:
(a) patient's name,
				noting any change from previous records;
(b) any paired organ involvement, noting
				sequence;
(c) subsequent histology,
				including dates, place, histology type, slide number and procedure;
(d) date, type of procedure and findings of
				any surgery or other exploratory measure;
(e) date and type of any administration of
				radiation;
(f) date of any
				administration of hormones, chemotherapy, immunotherapy or any other kind of
				treatment;
(g) date of death and/or
				last follow up;
(h) if death has
				occurred, the place, cause and whether an autopsy was performed;
(i) if an autopsy was performed, its findings
				pertaining to cancer;
(j) status at
				time of latest recorded information, i.e., whether alive or dead, tumor in
				evidence, or has recurred, or status is unknown;
(k) if recurrence of tumor, date, type, and
				distant sites of first recurrence; and
(l) names of those physicians primarily and
				secondarily responsible for follow up treatment.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.8 - RECORDS AND STATISTICS › Subchapter 37.8.18 - Tumor Registry › Rule 37.8.1808 - REQUIRED RECORDS, INDEPENDENT CLINICAL LABORATORIES

Current through Register Vol. 13, July 5, 2024
(1) Whenever a clinical laboratory which is
				not owned or operated by a hospital provides laboratory services for any
				patient relating to a tumor designated as reportable by ARM
				37.8.1801, it must collect,
				record, and make available to the department the following information about
				that patient:
(a) name and current address of
				patient;
(b) patient's address at
				time of diagnosis;
(c) social
				security number;
(d) name of
				spouse, if any;
(e) race, sex, and
				marital status;
(f) age at
				diagnosis, month, day, and year of birth;
(g) date and place of initial
				diagnosis;
(h) primary site of
				tumor (paired organ);
(i) sequence
				of primary tumors, if more than one;
(j) method of confirming diagnosis;
(k) histology, including dates, place,
				histologic type, and slide number;
(l) summary staging, including whether in
				situ, localized, regional, distant or unstaged, with no information, or whether
				AJCC or TNM staging is utilized, and, if so, the findings of the
				staging;
(m) description of tumor
				and its spread, if any, including size in centimeters, number of positive
				nodes, number of nodes examined, and site of distant metastasis;
(n) status at time of latest recorded
				information, i.e., whether alive or dead, tumor in evidence, or recurring, or
				status unknown; and
(o) names of
				physicians primarily and secondarily responsible for follow up.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.10 - EMERGENCY HEALTH SERVICES › Subchapter 37.10.1 - Living Wills › Rule 37.10.101 - DEFINITIONS

Current through Register Vol. 13, July 5, 2024
(1) "POLST" means Provider Orders for
				Life-Sustaining Treatment, a comprehensive statewide method of identifying a
				patient's wishes for providing palliative care, medical interventions, or
				withholding resuscitative measures to terminally ill patients who have a
				declaration governing the withholding or withdrawal of life-sustaining
				treatment or for whom a do-not-resuscitate (DNR) order has been issued pursuant
				to
				50-10-101,
				et seq., MCA.
(2) "POLST form"
				means a uniform, single form for statewide use, approved by the department and
				Board of Medical Examiners, indicating either that a valid and current
				declaration pursuant to
				50-9-103,
				MCA, has been executed and that the declarant is a qualified patient as defined
				in
				50-9-102,
				MCA, or that a provider has issued a DNR order for the patient pursuant to
				50-10-101,
				et seq., MCA.
(3) "Provider" means
				a physician, or advanced practice registered nurse. A physician assistant with
				a valid agreement with a supervising physician who has delegated the authority
				to sign DNR orders may also be considered a provider.
AUTH:
					 50-9-110,
					 MCA; IMP:
					 50-9-102,
					 50-9-106,
					 MCA
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.10 - EMERGENCY HEALTH SERVICES › Subchapter 37.10.1 - Living Wills › Rule 37.10.104 - LIVING WILL PROTOCOL FOR EMS PERSONNEL

Current through Register Vol. 13, July 5, 2024
(1)
				The living will protocol may also be designated the "POLST protocol". Providers
				may use POLST to implement DNR orders, or the end of life treatment decisions
				by a patient expressed through a living will or otherwise.
(2) For a patient who has completed a POLST
				form, emergency medical services personnel must follow the POLST protocol for
				providing palliative care or withholding life-sustaining procedures from a
				patient if a patient meets the following criteria:
(a) The identity of the patient has been
				clearly established and the personnel have been presented with any one of the
				following:
(i) a POLST form for the patient;
				or
(ii) a written DNR order signed
				and dated by a provider.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.10 - EMERGENCY HEALTH SERVICES › Subchapter 37.10.1 - Living Wills › Rule 37.10.105 - SOURCES OF POLST IDENTIFICATION

Current through Register Vol. 13, July 5, 2024
(1) POLST
				forms, cards, necklaces, and bracelets may be obtained only through:
(a) physicians;
(b) licensed hospice programs;
(c) licensed home health agencies;
(d) hospitals;
(e) skilled nursing facilities;
(f) long term care facilities; and
(g) any other entity specifically approved by
				the department.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.10 - EMERGENCY HEALTH SERVICES › Subchapter 37.10.1 - Living Wills › Rule 37.10.108 - DO-NOT-RESUSCITATE PROTOCOL

Current through Register Vol. 13, July 5, 2024
(1) POLST is the
				system used by medical professionals to identify and administer appropriate
				care, including DNR orders, to terminally ill patients.
(2) When issuing a DNR order for a patient
				with a terminal condition, medical professionals are encouraged to use the
				POLST form and follow the DNR/POLST protocol approved by the Board of Medical
				Examiners and the department. The department adopts and incorporates by
				reference the Montana Provider Orders for Life-Sustaining Treatment (POLST)
				protocol (last revised September 2019), which is accessible at the Board of
				Medical Examiner's website. A copy of the POLST protocol may also be obtained
				by contacting the department's EMS and Trauma System Section, 1400 Broadway,
				Room C303A, P.O. Box 202951, Helena, MT 59620-2951, 406-444-3895.
AUTH:
					 50-10-105,
					 MCA; IMP:
					 50-10-101,
					 MCA
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.2 - Approval of Laboratories › Rule 37.12.201 - REGISTRATION

Current through Register Vol. 13, July 5, 2024
(1) 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 from which
				it was secured shall register annually with the department, giving the name of
				such laboratory, its location and the name of the person or persons owning or
				operating the same.
(2) All
				laboratories doing public health work in the state of Montana shall register
				with the department. Such laboratories which meet the standards of the
				department shall be designated as approved laboratories.
AUTH:
					 50-1-202, MCA; IMP:
					 50-1-202,
					 MCA
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.2 - Approval of Laboratories › Rule 37.12.205 - APPROVAL

Current through Register Vol. 13, July 5, 2024
(1) 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.
AUTH:
					 50-1-202, MCA; IMP:
					 50-1-202,
					 MCA
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.2 - Approval of Laboratories › Rule 37.12.206 - INSPECTIONS

Current through Register Vol. 13, July 5, 2024
(1) 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.
AUTH:
					 50-1-202, MCA; IMP:
					 50-1-202,
					 MCA
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.304 - LABORATORY LICENSURE: COVERAGE

Current through Register Vol. 13, July 5, 2024
(1) 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
				the purpose of meeting the requirements of Title 75, chapter 6, MCA, and rules
				of the DEQ concerning public water supplies.
(2) A laboratory may be licensed to perform
				microbiology testing, chemical testing, or both. Microbiology testing and
				chemical testing are separate licensure categories. If a laboratory requests
				licensure for both categories, it must submit to the department a separate
				license application and undergo a separate inspection for each category, and it
				will receive a separate license for each category for which it
				qualifies.
(3) A license granted by
				the department constitutes permission to perform only those analyses of
				analytes and using only those methods for which the laboratory requests the
				licensure to cover and that the department finds the laboratory is capable of
				performing in accordance with the provisions of this subchapter.
50-1-202,
					 MCA; IMP,
					 50-1-202,
					 75-6-106,
					 MCA;
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.305 - PROCEDURE FOR LICENSURE

Current through Register Vol. 13, July 5, 2024
(1) Any laboratory
				not currently licensed but desiring licensure under this subchapter must:
(a) submit a completed application to the
				Department of Public Health and Human Services, Laboratory Services Bureau,
				1400 Broadway, Cogswell Building, P.O. Box 4369, Helena, MT 59604-4369, on
				forms provided by the department. The application must include:
(i) the legal name of the
				laboratory;
(ii) the name of the
				laboratory owner;
(iii) the
				laboratory mailing address;
(iv)
				the full address of the physical location of the laboratory;
(v) the laboratory hours of
				operation;
(vi) a description of
				qualifications of key personnel and technical employees;
(vii) the name and daytime phone number of
				the laboratory director;
(viii) the
				name and daytime phone number of the laboratory's quality assurance
				officer;
(ix) the name and daytime
				phone number of the laboratory contact person; and
(x) the laboratory's quality assurance plan
				and documentation of the laboratory's implementation and adherence to the
				quality assurance plan.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.306 - STANDARDS, INSPECTIONS, AND TESTS REQUIRED FOR LICENSURE

Current through Register Vol. 13, July 5, 2024
(1) In order to be licensed, a laboratory
				must:
(a) meet all of the applicable
				personnel, equipment, training, and facility requirements of this
				subchapter;
(b) at least once
				during the three-year term of its license, pass an on-site inspection by an
				agent of the environmental laboratory that shows compliance with the
				requirements of these rules for the license category in question;
(c) if the laboratory performs chemical
				analyses, have performed analyses on at least two performance evaluation (PE)
				samples for each analyte or interdependent analyte group and each method each
				year during the term of its license; and
(d) if the laboratory performs
				microbiological analyses, have successfully performed analyses on at least two
				performance evaluation (PE) samples for each analyte and method each year
				during the term of its license.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.310 - LICENSURE FEES

Current through Register Vol. 13, July 5, 2024
(1) 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 laboratories that wish to be licensed prior to July 1 will pay full
				licensure fees; after July 1 of the fiscal year the licensure fees will be
				prorated 50%:
(a) $250 with an application
				for an initial microbiology, inorganic chemistry, or organic chemistry license.
				This application fee will only be charged when issuing a first-time license or
				issuing a new license after a license has lapsed;
(b) $550 licensure fee for an organic
				chemistry license for an in-state laboratory;
(c) $990 licensure fee for an organic
				chemistry license for a laboratory licensed by reciprocity;
(d) $350 licensure fee for an inorganic
				chemistry license for an in-state laboratory;
(e) $600 licensure fee for an inorganic
				chemistry license for a laboratory licensed by reciprocity;
(f) $350 licensure fee for a microbiology
				license for an in-state laboratory;
(g) $600 licensure fee for a microbiology
				license for a laboratory licensed by reciprocity;
(h) $300 plus travel expenses for an
				inspection to determine if the holder of a conditional license qualifies for a
				full license or for a second inspection during the three-year term of a license
				that is necessary for approval of a new laboratory location; there is no charge
				for one inspection during the term of the license;
(i) $125 per day for training in the
				environmental laboratory;
(j) $300
				per day, plus travel expenses of environmental laboratory staff, for on-site
				training and technical assistance outside of licensure inspections by the
				Laboratory Services Bureau staff.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.311 - DURATION OF LICENSE

Current through Register Vol. 13, July 5, 2024
(1) A license
				granted to an in-state laboratory is for a three year period provided:
(a) all of the requirements of this
				subchapter continue to be met for the type of license granted;
(b) the laboratory completes annual
				questionnaires from the department designed to update the department on
				personnel and procedures; and
(c)
				the laboratory remits to the department the appropriate annual licensure fee
				and any other fees due pursuant to ARM
				37.12.310.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.312 - LICENSE

Current through Register Vol. 13, July 5, 2024
(1) 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:
(a) is in compliance with
				all requirements for licensure but has not yet analyzed a second PE sample or
				does not have records of historical performance; or
(b) does not comply with all of the
				requirements of this subchapter, but whose deficiencies do not affect the
				capability of the laboratory to perform valid analyses.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.313 - RECIPROCITY

Current through Register Vol. 13, July 5, 2024
(1) 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:
(a)
				applies for licensure and is currently approved by the Environmental Protection
				Agency or the state in which the laboratory is located if that state has a
				certification program approved by EPA for laboratories analyzing water from
				public water supplies;
(b) the EPA
				or the state's certifying authority, whichever is appropriate, provides the
				department with a copy of the laboratory's current certification and most
				recent inspection report;
(c) the
				requirements for certification in the approving state are no less stringent
				than the requirements for resident laboratories in the state of
				Montana;
(d) the laboratory submits
				qualification information for all key personnel and provides the department
				with a current copy of the laboratory's quality assurance plan;
(e) the laboratory performs, analyzes, and
				successfully passes PE audits for analytes from sources approved by the
				department. The provider of the PE samples shall report results of the analyses
				directly to the department; and
(f)
				the laboratory complies with the notification requirements of ARM
				37.12.324,
				37.12.325, and
				37.12.326.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.314 - RESTRICTION OF LICENSE

Current through Register Vol. 13, July 5, 2024
(1) 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
				department will notify the Department of Environmental Quality of any
				laboratories that have been downgraded to provisional status. Downgrading to
				provisional status may occur under the following circumstances:
(a) the laboratory reports results of an
				analysis of PE samples that are outside acceptable limits, and does not
				successfully perform analysis on a second set of PE samples within 90 days of
				receipt of the original report, or it fails to report results of a PE sample
				analysis for any analyte that the laboratory is approved to analyze. In this
				case:
(i) the laboratory's license is
				provisional only in regard to the laboratory's approval to conduct analyses of
				the particular analyte or method involved;
(ii) the provisional status remains in effect
				until the next available PE results are reported to the department, at which
				time:
(A) the conditions will be removed if
				acceptable PE results are reported to the department; or
(B) approval to conduct the analysis in
				question will be revoked if unacceptable PE results are reported to the
				department.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.315 - REVOCATION OR DENIAL OF LICENSE

Current through Register Vol. 13, July 5, 2024
(1) 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:
(a) fails to analyze and
				report results of at least two PE samples per year;
(b) reports unacceptable results or fails to
				report the results of analyses of two consecutive PE samples for an analyte for
				which the laboratory is approved;
(c) fails to correct cited deficiencies
				within the time specified by the department or fails to adhere to conditions of
				a waiver or variance;
(d) no longer
				employs a director or analysts who have satisfied the requirements of this
				subchapter;
(e) does not use
				EPA-approved methods to perform analyses;
(f) does not perform required quality control
				procedures;
(g) falsifies data or
				engages in deceptive practices such as reporting another laboratory's data
				without giving credit on the report to the laboratory which performed the
				analysis;
(h) reports data that
				were obtained using equipment, procedures, analysts, methods, or facilities
				that are not approved by the department;
(i) fails to report to the Department of
				Environmental Quality within the time frames described in ARM
				37.12.341 the results of any
				sample required under ARM Title 17, chapter 38, subchapter 2, and accepted by
				the laboratory for analysis, that exceeds a maximum contaminant level (MCL) or
				triggers additional actions; or
(j)
				fails to report results on forms or formats acceptable to the Department of
				Environmental Quality.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.316 - REISSUANCE OF LICENSE

Current through Register Vol. 13, July 5, 2024
(1) 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 when a compliance schedule has been set to meet all additional requirements
				of this subchapter.
(2) If the
				laboratory does not fulfill the terms of the compliance plan, the license will
				again be revoked pursuant to ARM 37.12.315.
(3) A laboratory may request technical
				assistance from the department to remediate any deficiencies. The department
				shall provide the technical assistance as soon as is practical.
(4) The department adopts and incorporates by
				reference the EPA laboratory certification manual (EPA 815-R-05-004, "Manual
				for the Certification of Laboratories Analyzing Drinking Water," January 2005),
				which contains criteria, procedures, and quality assurance standards required
				by the EPA that must be met by laboratories analyzing drinking water to
				determine compliance with the federal Clean Water Act and its rules. A copy of
				the manual may be obtained from the Department of Public Health and Human
				Services, Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O.
				Box 4369, Helena, MT 59604-4369, telephone (406) 444-3444, or may be downloaded
				at the EPA web site:
https://www.epa.gov/dwlabcert/laboratory-certification-manual-drinking-water
.
AUTH:
					 50-1-202, MCA; IMP:
					 50-1-202,
					 75-6-106,
					 MCA
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.320 - PROFICIENCY TESTING

Current through Register Vol. 13, July 5, 2024
(1) 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 rule.
(2) In order to
				initially obtain and to maintain approval, the laboratory must:
(a) whenever required by the EPA, enroll and
				participate in a proficiency testing program approved by the environmental
				laboratory for each analyte or interdependent analyte group, or, for each
				analyte or interdependent analyte group and method for which proficiency
				testing is not available or required, the laboratory must establish, maintain,
				and document the accuracy and reliability of its procedures through a quality
				assurance plan;
(b) successfully
				participate in at least two proficiency tests annually;
(c) prior to obtaining approval, notify the
				department of the authorized proficiency testing program or programs in which
				it has enrolled for each analyte or interdependent analyte group and method
				approved under its license to analyze;
(d) follow the proficiency testing provider's
				instructions for preparing the proficiency testing sample and must analyze the
				proficiency testing sample as if it were a client sample;
(e) direct the proficiency testing provider
				to send, either in hard copy or electronically, a copy of each evaluation of
				the laboratory's proficiency testing audit results to the department;
				and
(f) authorize the proficiency
				testing provider to release to the department all information necessary for the
				department to assess the laboratory's compliance with this rule.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.324 - REQUIRED NOTIFICATION OF CHANGES

Current through Register Vol. 13, July 5, 2024
(1)
				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
				reporting results of tests used in regulatory compliance. A change in personnel
				is defined as the loss or replacement of the laboratory supervisor or a
				situation in which a trained and experienced analyst is no longer available to
				analyze a particular parameter for which licensure has been granted.
(2) After receiving the notification, the
				department may place conditions upon the laboratory's license pursuant to ARM
				37.12.314.
50-1-202,
					 MCA; IMP,
					 50-1-202,
					 75-6-106,
					 MCA;
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.325 - REQUIRED NOTIFICATION OF CHANGE IN NAME

Current through Register Vol. 13, July 5, 2024
(1) 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.
50-1-202,
					 MCA; IMP,
					 50-1-202,
					 75-6-106,
					 MCA;
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.326 - REQUIRED NOTIFICATION OF CHANGE IN LOCATION

Current through Register Vol. 13, July 5, 2024
(1) 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:
(a) the full physical address of the new
				location;
(b) a notification of any
				personnel, equipment, or analytic method changes which will occur as a result
				of the relocation; and
(c) a signed
				statement either that the laboratory quality assurance plan will not be
				affected by the relocation, or, if it will be, that the plan will be revised to
				address the necessary changes.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.327 - ACCESS TO FACILITY AND RECORDS

Current through Register Vol. 13, July 5, 2024
(1) 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 compliance with this subchapter.
(2) Whenever possible, inspections will be
				scheduled in advance so that they do not interfere with routine laboratory
				operations. However, whenever necessary to protect public health, unannounced
				inspections will be conducted.
(3)
				If an unannounced inspection causes a business hardship or may result in harm
				to laboratory clients, the laboratory director will give the department notice
				of that fact at the time of inspection and the department will make whatever
				accommodations may be made to alleviate the hardship or harm while still
				protecting public health.
Sec.
					 50-1-202,
					 MCA; IMP, Sec.
					 50-1-202
					 and
					 75-6-106,
					 MCA;
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.330 - BLIND SAMPLE TESTING

Current through Register Vol. 13, July 5, 2024
(1) 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 blind samples to the department when later notified that a sample
				was a blind sample.
Sec.
					 50-1-202,
					 MCA; IMP, Sec.
					 50-1-202
					 and
					 75-6-106,
					 MCA;
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.333 - APPROVAL TO CONDUCT ANALYSES

Current through Register Vol. 13, July 5, 2024
(1) Analyses
				must be conducted using current EPA approved methods in accordance with the
				analytical requirements set forth in 40 CFR 141.
(2) Alternate analytical procedures are not
				permitted unless such procedures satisfy
				40 CFR
				141.27 and have been approved by the
				EPA.
(3) An applicant laboratory
				must request approval to analyze for an analyte or interdependent analyte group
				and the method(s) used as part of its application for licensure or renewal of a
				license.
(4) Approval for such
				analyses will be granted only after an on-site assessment. The applicant
				laboratory shall submit:
(a) documentation
				that it has the necessary equipment and qualified technical employees to
				preform the tests;
(b) for
				chemistry analysis, documentation that the laboratory has successfully passed
				two proficiency testing audits for the analyte and method in question from an
				approved proficiency testing program;
(c) its standard operating procedure for the
				method used to analyze for the analyte in question;
(d) documentation of its initial
				demonstration of analytical capability; and
(e) documentation establishing the
				laboratory's method detection limit for each chemical analyte.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.336 - QUALITY ASSURANCE

Current through Register Vol. 13, July 5, 2024
(1) 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 standards of quality with its stated level of confidence.
(2) The quality assurance program must
				address the type of testing activities the licensed laboratory undertakes and
				how quality assurance activities may change with changes in sample volumes. The
				quality assurance program must include a quality assurance plan and
				documentation of quality assurance activities.
(3) As part of its quality assurance program,
				each licensed laboratory must develop and adhere to a quality assurance plan.
				The laboratory must include and address the following essential items in the
				quality assurance plan:
(a) listing of key
				individuals, laboratory organization and lines of responsibility;
(b) position descriptions;
(c) evaluation of staff competency;
(d) staff training;
(e) general quality control
				procedures;
(f) frequency of
				proficiency testing;
(g)
				proficiency testing audit handling;
(h) reporting of proficiency testing
				results;
(i) analytical methods and
				SOPs with annual reviews and dates of revisions of the methods and
				SOPs;
(j) sample handling
				procedures;
(k) data reduction,
				validation, reporting, and verification (an SOP may be referenced);
(l) record keeping, quality assurance review
				of data, and reporting of results;
(m) equipment operation and
				calibration;
(n) physical facility
				factors that may affect quality;
(o) corrective action policy and
				procedures;
(p) definitions of
				terms used in the quality assurance plan;
(q) frequency and procedure of quality
				reviews and the content of reports to the laboratory director; and
(r) frequency, procedure, and documentation
				of preventive maintenance.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.337 - SAFETY

Current through Register Vol. 13, July 5, 2024
(1) 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
				and adopted by the Department of Labor and Industry.
(a) The department adopts and incorporates by
				reference those portions of ARM
				24.30.2501 through 24.30.2558,
				which contain requirements that employers must meet concerning the
				establishment of educational safety programs and safety programs for employers
				who employ more than five employees. A copy of those rules may be obtained from
				the Department of Public Health and Human Services, Office of Legal Affairs,
				111 North Sanders, Sanders Building, P.O. Box 4210, Helena, MT
				59604-4210.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.338 - LABORATORY EQUIPMENT AND SUPPLIES

Current through Register Vol. 13, July 5, 2024
(1) 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.
(2) The equipment and supplies must meet the
				specifications required by the approved analytical method used and the
				specifications specified in the EPA laboratory certification manual for that
				method.
(3) Analytical reagent
				(AR) grade chemicals or better must be used for analyses.
(4) The laboratory must have a source of
				distilled, deionized, or reagent grade water that meets all the requirements
				listed in the EPA laboratory certification manual and the requirements of the
				analytical method being used.
(5)
				The department adopts and incorporates by reference the standards contained in
				the EPA laboratory certification manual (EPA 815-R-05-004, "Manual for the
				Certification of Laboratories Analyzing Drinking Water," January 2005) for
				sources of distilled, deionized water, or reagent grade water. A copy of the
				manual may be obtained from the Department of Public Health and Human Services,
				Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box 4369,
				Helena, MT 59604-4369, telephone (406) 444-3444, or may be downloaded at the
				EPA web site:
https://www.epa.gov/dwlabcert/laboratory-certification-manual-drinking-water
.
AUTH:
					 50-1-202, MCA; IMP:
					 50-1-202,
					 75-6-106,
					 MCA
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.341 - REPORTING REQUIREMENTS

Current through Register Vol. 13, July 5, 2024
(1) 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
				promptly, on the day the result is determined or no later than noon the next
				working day, reported by the laboratory to the Montana Department of
				Environmental Quality (MDEQ). Results must be reported to the Public Water
				Supply Section of the MDEQ either electronically to dpws@mt.gov or by telephone
				to (406) 444-1947. The written sample result must be submitted to MDEQ on forms
				and in formats approved by the MDEQ within 48 hours of completion of the
				analysis. When a maximum contaminant level as set out in ARM Title 17, chapter
				38, subchapter 2 is found to be exceeded in any sample, the reporting
				laboratory accepting the sample for analysis from the water supplier must
				notify the water supplier of that result within 24 hours after the analysis is
				completed.
(2) The analytical
				result of all microbiological or chemical samples accepted by the laboratory
				for analysis, other than those which are defined in ARM
				37.12.341(1),
				must be reported to the MDEQ within a week after completion of the analysis.
				The results must be submitted on forms and in formats approved by the
				MDEQ.
50-1-202,
					 MCA; IMP,
					 50-1-202,
					 75-6-106,
					 MCA;
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.342 - REPORTING RESULTS FROM OTHER LABORATORIES

Current through Register Vol. 13, July 5, 2024
(1) 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.
(2) A laboratory that reports analyses
				performed by other laboratories is required to report all analyte results that
				are used for regulatory compliance, to the Montana Department of Environmental
				Quality.
50-1-202,
					 MCA; IMP,
					 50-1-202,
					 75-6-106,
					 MCA;
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.345 - CRITICAL ELEMENTS FOR CHEMISTRY LABORATORY LICENSURE

Current through Register Vol. 13, July 5, 2024
(1) In order to be licensed to perform
				chemical analyses, a laboratory must meet the standards contained in this rule.
(2) Analysts in training must be
				supervised by an experienced analyst who meets all of the requirements of this
				rule.
(3) Supervising analysts
				must verify all results of testing performed by analysts in training and cosign
				those results.
(4) The
				laboratory's analysts must:
(a) meet all of
				the qualifications and conditions set forth in chapter IV of the EPA laboratory
				certification manual, and if responsible for the operation of analytical
				instrumentation, complete specialized training offered by the manufacturer or
				another qualified training facility approved by the department, or served a
				period of apprenticeship under an experienced analyst. The duration of this
				apprenticeship should be proportional to the sophistication of the instrument;
				and
(b) provide certification
				and/or training and experience documentation to the department for review and
				approval as part of the laboratory licensure and inspection process.
Administrative Rules of Montana › Department 37 - PUBLIC HEALTH AND HUMAN SERVICES › Chapter 37.12 - LABORATORIES › Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies › Rule 37.12.346 - CRITICAL ELEMENTS FOR MICROBIOLOGY LABORATORY LICENSURE

Current through Register Vol. 13, July 5, 2024
(1) In order to be licensed to perform
				microbiological analyses, a laboratory must meet the standards contained in
				this rule.
(2) Individual analysts
				must be approved by the state as meeting the standards of this rule in order to
				perform microbiological analysis of drinking water samples.
(3) Analysts in training must be supervised
				by an experienced analyst who meets all of the requirements of this rule.
(4) Supervising analysts must
				verify all results of testing performed by analysts in training and co-sign
				those results.
(5) A laboratory
				must meet all of the qualifications and conditions set forth in chapter V of
				the EPA laboratory certification manual.
(a)
				Analysts must have a minimum of two days of training at the environmental
				laboratory with a successful evaluation from the state training personnel.
				Documentation of independent certification or prior experience and training as
				approved by the department may be substituted for this training.