reglab/statecodes huggingface dataset:
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 253 - MAINE CHRONIC DISEASE SURVEILLANCE DATA QUALITY AND FOLLOW-UP STUDY RULES › Section 144-253-5 - IDENTIFYING INFORMATION

Current through 2024-29, July 17, 2024
A. Limitations of
				use of identifying information
1 Identifying
				information shall be used only to gain access to medical records and other
				medical information pertaining to an advisory body approved investigation
				designed to accomplish public health research of substantial public importance
				as related to chronic disease or data quality investigations.
2 Identifying information shall be used to
				the minimum extent possible to accomplish the purposes of the approved
				investigation.
3 Medical
				information about an identified patient shall not be sought from any person
				without the consent of that patient except when the information sought pertains
				solely to verification or comparison of health data that the department is
				otherwise authorized by law to collect and the advisory body finds that
				confidentiality can be adequately protected without patient consent as set
				forth in Section 7.
4 Access to
				privileged medical information will be restricted to Department personnel
				essential for the conduct of such investigations or personnel appointed by the
				Department. Tasks performed by such personnel may include, but are not limited
				to, such functions as:
a medical record
				reviews
b audits and
				abstractions
c review of discharge
				summaries
d processing of
				abstracted or summary information
e
				compilation of datasets
f variable
				lists for database corroboration and hardcopy records
g analysis of data with confidential data
				elements
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 253 - MAINE CHRONIC DISEASE SURVEILLANCE DATA QUALITY AND FOLLOW-UP STUDY RULES › Section 144-253-6 - ADVISORY BODY

Current through 2024-29, July 17, 2024
A. Precedent for
				and establishment of the advisory body
1 In
				accordance with 22 MRSA Section1692-B an advisory body, independent from the
				department, shall be established and charged with responsibility for approving
				the protocol of the investigation, overseeing the conduct of the investigation
				to assure consistency with the protocol and the department's rules, and
				assessing both the scientific validity of the investigation and its effects
				upon patients, if any.
2 The
				advisory body to Maine chronic disease surveillance programs shall consist of
				the Maine Cancer Prevention and Control Advisory Committee to include a
				consumer representative, a practicing physician and a member of the Maine
				Medical Records Association. The Commissioner shall appoint additional members,
				if needed to meet these requirements, and they shall each serve a two year
				term.
3 The Cancer Prevention and
				Control Advisory Committee was appointed in accordance with 22 MRSA
				Section1405.
4 The Department may
				consider attempting to obtain recognition of the advisory body as a Federally
				approved Institutional Review Board (IRB) for the purposes of Human Subjects
				Protection. The Commissioner may appoint any additional members whose expertise
				is deemed necessary to accomplish this purpose.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 253 - MAINE CHRONIC DISEASE SURVEILLANCE DATA QUALITY AND FOLLOW-UP STUDY RULES › Section 144-253-8 - PROTOCOLS

Current through 2024-29, July 17, 2024
A. The advisory body may approve a general
				protocol for use by the Department in situations involving routine verification
				of chronic disease or data quality investigations. The advisory body shall
				determine if the use of such a protocol is appropriate when privileged medical
				information is requested. Any investigation in which it is anticipated that
				individual patients/cases will be contacted, shall, prior to the investigation
				have an established advisory body approved study-specific protocol. The study
				protocol shall include or consider:
1
				Statement of the health problem to be investigated
2 Relevant historical background with
				pertinent review of the literature
3 Purpose and objectives of the
				study
4 Methodology:
(a) Study design
(b) Variables to be collected
(c) Populations to be contacted; method of
				contact
(d) Data
				collection
(e) Data
				analysis
(f) Assurances of human
				subjects protection including:
i
				Confidentiality guidelines
ii
				Patient/case contact guidelines
iii
				Patient/case and physician consent guidelines
5 Reporting requirements
6 Statutory authority
7 Qualifications and affiliations of the
				investigators
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 253 - MAINE CHRONIC DISEASE SURVEILLANCE DATA QUALITY AND FOLLOW-UP STUDY RULES › Section 144-253-9 - REIMBURSEMENT

Current through 2024-29, July 17, 2024
Whenever a physician, hospital, institution or agency
				  furnishes patient or case information requested by the department in accordance
				  with these rules, and the expenses for such activities are not voluntarily
				  absorbed, the department shall reimburse the physician, hospital, institution
				  or agency for reasonable costs, as determined by the advisory body's review and
				  recommendation and provided for by
				   5 MRSA
				  Section2051, which are incurred in providing
				  this information.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 254 - OCCUPATIONAL DISEASE REPORTING RULES AND REGULATIONS › Section 144-254-1 - DEFINITIONS

Current through 2024-29, July 17, 2024
A.
Bureau
: The Department of
				Health and Human Services, Bureau of Health.
B.
Causative Agent
: Substance or
				factor which is suspected to have precipitated the onset of the disease being
				reported.
C.
Chiropractor
. Chiropractor registered and licensed by the Maine
				State Board of Chiropractic Licensure.
D.
Commissioner
: The
				Commissioner of the Department of Health and Human Services, State of
				Maine.
E.
Confidentiality
: The extension of an individual's right of
				privacy; the process of how information once collected will be
				maintained.
F.
Department
: The State of Maine Department of Health and Human
				Services
G.
Director
:
				The director of the Bureau of Health.
H.
Division
: The Department of
				Health and Human Services, Bureau of Health, Division of Disease
				Control.
I.
Hospital:
Any hospital licensed by the Department.
J.
Industry
: The particular type
				of activity or business within which the occupation, which resulted in the
				exposure causing the illness, was found.
K.
Physician
: Physician
				registered and licensed by either the Board of Licensure in Medicine, State of
				Maine or by the Board of Osteopathic Licensure.
L.
Physician Extender
: A
				Physician Assistant or Nurse Practitioner registered by the Board of Licensure
				in Medicine, the Board of Osteopathic Licensure, or other licensing body
				authorized under Maine law.
M.
Occupation
; The type of job the individual was engaged in which is
				believed to have resulted in exposure to the agent causing the illness or
				injury.
N.
Occupational
				Disease
: Any abnormal condition or disorder, including an occupational
				injury, caused by exposure to environmental factors associated with
				employment.
O.
Reportable
				Case
: Any newly diagnosed patient with a reportable occupational disease
				or injury.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 254 - OCCUPATIONAL DISEASE REPORTING RULES AND REGULATIONS › Section 144-254-2 - INTRODUCTION

Current through 2024-29, July 17, 2024
The objectives of the State of Maine's Occupational Disease
				  Reporting Program are to collect case specific data on all persons diagnosed
				  with occupational diseases living in Maine; to tabulate and summarize patient
				  data to determine the frequency and incidence rates for reportable occupational
				  diseases by age, sex, and disease for geographic areas; to evaluate factors
				  which might determine the incidence and prevent the future occurrence of
				  occupational diseases among workers employed in the State of Maine. In
				  accordance with
				   22 M.R.S.A.,
				  Section1492, this data shall be shared with
				  the Maine Department of Labor who may conduct site visits, inspections,
				  initiate investigations or take other appropriate actions.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 254 - OCCUPATIONAL DISEASE REPORTING RULES AND REGULATIONS › Section 144-254-3 - REPORTABLE DISEASES

Current through 2024-29, July 17, 2024
Hospitals, Physicians, Physician Extenders, and Chiropractors
				  shall submit the required information described in section (4) on the diseases
				  listed and defined in this section to the Department no later than 30 days from
				  the date of diagnosis (or suspected diagnosis or discharge from a
				  hospital.
The following reportable categories are based mainly on type
				  of occupational exposure except where symptoms could be caused by various
				  agents.
- Any injury associated with agricultural work which results
				  in death or requires care by a Hospital, Physician , Physician Extender, or
				  Chiropractor.
- Asbestosis
- Byssinosis
- Carpal Tunnel Syndrome
- Heavy Metal Poisoning
Arsenic
Cadmium
Lead
Mercury
- Hypersensitivity Pneumonitis
- Mesothelioma
- Occupational Asthma
- Outbreaks
- Pesticide Poisoning
Carbamate Pesticides
Bipyridyl Herbicides
Dinitrophenol Herbicides
Organochlorine Pesticides
Organophosphate Insecticides
Synthetic Pyrethrin Pesticides
Triazine Herbicides
Miscellaneous Pesticides
- Silicosis
- Solvent Toxicity
- Toxic Gas Poisoning
Ammonia
Carbon Monoxide
Chlorine
Hydrogen Sulfide
Miscellaneous
The department maintains a criteria guide which outlines the
				  reportable diseases, their symptomology, their causative agents and their
				  occupational exposures. This guide is updated periodically and is available
				  upon request.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 254 - OCCUPATIONAL DISEASE REPORTING RULES AND REGULATIONS › Section 144-254-4 - REQUIRED DATA

Current through 2024-29, July 17, 2024
The following information shall be provided with each
				  occupational disease report. (Information may be reported by phone using the
				  Bureau of Health's toll free number 1-800-821-5821, on Department supplied
				  forms, or by writing to the Occupational Disease Program, Maine Bureau of
				  Health, Division of Disease Control, State House Station 11, Augusta, Maine,
				  04333.)
- Name and phone number of physician/hospital/person making
				  the report
- Name of disease (illness or injury diagnosis)
- Causative agent or mode of injury
- Date of diagnosis
- Attending physician
- Patient's name
- Patient's residence
- Social Security Number
- Mailing address of patient
- Birthdate
- Sex
- Race
- Occupation
- Industry
- Employer name and address
- Any factor known to the physician which is suspected of
				  being a contributing factor to the disease, including, but not limited to,
				  whether or nor the person smokes and, if so, the frequency of
				  smoking.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 254 - OCCUPATIONAL DISEASE REPORTING RULES AND REGULATIONS › Section 144-254-5 - CONFIDENTIALITY OF REPORTED DATA

Current through 2024-29, July 17, 2024
In accordance with
				   22 MRSA,
				  Section1494, individual names and related
				  information which may identify individuals as having an occupational disease
				  shall be confidential and may be released only to other public health
				  officials, agents or agencies, or by court order or by written authorization of
				  the individual on which the report has been filed with the Department.
The Department may contact the reporting authority for
				  further information or for permission to contact the patient.
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Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 255 - CANCER INCIDENCE REGISTRY REGULATIONS › Section 144-255-1 - DEFINITIONS

Current through 2024-29, July 17, 2024
A. Department means the Department of Human
				Services.
B. Director means the
				director of the Bureau of Health.
C. Reporting Facility means any hospital,
				pathology laboratory, rural health clinic, ambulatory care facility, ambulatory
				surgery center, radiation therapy center, or other health care facility,
				providing screening, diagnostic or therapeutic services to patients with
				respect to cancer, which is licensed to operate in the State of
				Maine.
D. Reportable Case means any
				newly diagnosed cancer patient.
E.
				Confidentiality means the extension of an individual's right of privacy; the
				process of how information once collected will be maintained.
F. Reporting Physician means a licensed
				health care provider who diagnoses or treats a cancer case which has not nor
				will be directly referred to a treatment facility for diagnosis or treatment of
				that instance of cancer.
G.
				Certified Tumor Registrar means any individual who has passed the Certification
				Examination for Cancer Registrars and who meets the current continuing
				education requirements of the National Cancer Registrars Association.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 255 - CANCER INCIDENCE REGISTRY REGULATIONS › Section 144-255-2 - INTRODUCTION

Current through 2024-29, July 17, 2024
The objectives of the State of Maine's Cancer Incidence
				  Registry Program (MCR) are to collect case-specific data on all persons
				  diagnosed with cancer living in Maine and, to the extent feasible, those Maine
				  residents who are either diagnosed or die out of state; to tabulate and
				  summarize patient data to determine the frequency and incidence rates by age,
				  sex, and type of cancer for geographic areas; to evaluate factors which might
				  determine the incidence of cancer or survival of cancer patients; and to assist
				  others interested in improving the control of cancer among residents of the
				  State of Maine.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 255 - CANCER INCIDENCE REGISTRY REGULATIONS › Section 144-255-3 - REQUIRED DATA ELEMENTS

Current through 2024-29, July 17, 2024
Patient data should only be sent to the State Registry for
				  all reportable cancer cases and shall be submitted on materials described in
				  section
				  5 (B). The following information shall be submitted
				  by reporting facilities and reporting physicians to the Department to identify
				  cancer patients, the type of cancer the patient has, and the
				   facility where the patient was
				  diagnosed:
Reporting Facility/Physician
Sequence Number
Patient's Last Name (including Maiden Name)
Patient's First Name and Middle Initial
Birthdate
Address at Diagnosis; including
City or Town of Residence
County of Residence
State of Residence and Zip Code
Sex
Race
Attending Physician
Referring Physician
Date of Diagnosis
Topography of Cancer (ICD-O Second Edition)
Morphology of Cancer (ICD-O Second Edition)
Usual Occupation
Usual Industry
Social Security Number
Stage of Disease at Diagnosis (most current AJCC coding
				  system)
Patient's Mailing Address
Date of Admission
Laterality
Grade
Spanish/Hispanic Origin
Diagnostic Confirmation
Summary Stage
Date of First Course of Treatment (when available in the
				  medical record)
Type of First Course of Treatment (when available in the
				  medical record)
Supporting Text Fields
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 255 - CANCER INCIDENCE REGISTRY REGULATIONS › Section 144-255-4 - OPTIONAL DATA ELEMENTS

Current through 2024-29, July 17, 2024
Additional information on cancer patients may be submitted
				  when prior arrangements are made between reporting facilities/reporting
				  physicians and the Cancer Registry and approval is given by the Cancer Registry
				  Program Subcommittee.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 255 - CANCER INCIDENCE REGISTRY REGULATIONS › Section 144-255-5 - PROGRAM OPERATION AND ANNUAL REPORT

Current through 2024-29, July 17, 2024
A. Data
				Submission
1. New Patient Information. Data
				on cancer patients shall be submitted to the Department within 30 days from the
				date of diagnosis or discharge. In the event that more time is needed to obtain
				or verify the accuracy of required information, the facility/physician may
				delay submission of patient data for an additional five months (150 days).
				Optional data elements may be submitted at any time.
2. Data Collection. The preferred method for
				submission of data from reporting facilities to the MCR is by electronic
				transfer. Data should be transmitted via Internet, by modem, or sent by 31/12"
				or 51/14" diskette; however, data may be submitted in the form of paper
				abstracts, if mitigating circumstances prohibit electronic transfer. The
				Department will make telecommunication software, a toll free telecommunications
				line, or data forms, available to reporting facilities/physicians. Reporting
				facilities/physicians are required to report in one of the standard formats
				adopted by the MCR.
3. Because of
				the technical nature of the reportable data, the MCR strongly urges reporting
				facilities, if they have not already done so, to obtain the services of a
				Certified Tumor Registrar (CTR) for the purpose of coding the cancer data that
				are to be sent to the MCR. This expertise may be obtained by agreement with
				another facility, a qualified individual or the MCR.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 255 - CANCER INCIDENCE REGISTRY REGULATIONS › Section 144-255-6 - CONFIDENTIALITY OF CANCER REGISTRY DATA

Current through 2024-29, July 17, 2024
A. Bureau of
				Health
Measures for assuring confidentiality and integrity of the
				  Cancer Registry Data Base as well as restricting access to case specific data
				  by employees of the Bureau of Health and others include:
1. establishing a series of passwords and
				internal security codes for access to the Cancer Registry Data Base,
2. storing all completed client data forms in
				a locked file cabinet, and
3.
				disposing of all Cancer Registry preliminary data listings, test retrievals,
				and other sensitive information in a confidential manner.
4. All MCR staff, both permanent and
				temporary, as well as individuals visiting the MCR in a professional capacity
				shall be required to sign a confidentiality agreement.
Bureau of Health personnel having access to client-specific
				  information is limited to personnel essential for the conduct of this
				  program.
Data retrievals to examine the consistency and quality of
				  patient information will be conducted as necessary. Annual reports and other
				  routine data retrievals will be conducted on a scheduled basis. Data on cancer
				  patients whose legal address is outside of the State of Maine may be shared
				  with other cancer registries if a reciprocal data sharing agreement is
				  implemented with that registry. The Maine Cancer Registry will insure that
				  agreements with other cancer registries include data confidentiality
				  provisions.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-1 - DEFINITIONS

Current through 2024-29, July 17, 2024
As used in these rules the following terms have the
					 following meanings, unless the context indicates otherwise.
1.1
Approved accreditation organization
				  for laboratories.
"Approved accreditation organization for laboratories"
				  means a private, nonprofit accreditation organization that has formally applied
				  for and received approval from the federal Centers for Medicare and Medicaid
				  Services (CMS) based on the organization's compliance with federal CLIA
				  regulations. See 42 Code of Federal Regulations (CFR) Part 493.
1.2
Category of testing by complexity.
				  "
Category of testing by complexity" means laboratory tests are
				  categorized by complexity as one of the following:
(1) waived tests;
(2) tests of moderate complexity, including
				  provider-performed microscopy (PPM) procedures; or
(3) tests of high complexity. See 42 C.F.R.
				  Part 493.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-2 - CLIA CERTIFICATION

Current through 2024-29, July 17, 2024
2.1
CLIA
				  certification required.
All medical laboratories that perform testing on
				  human specimens must be certified pursuant to the federal Clinical Laboratory
				  Improvement Amendments of 1988 (CLIA), as amended. Laboratories subject to PART
				  ONE or PART TWO of these rules must comply with CLIA.
2.2
Federal CLIA standards and
				  certification requirements.
All applicants and certificate-holders must
				  comply with the federal CLIA standards and certification requirements set forth
				  in 42 Code of Federal Regulations Part 493, as revised October 1, 2010, which
				  is incorporated herein by reference pursuant to
				   5 M.R.S.A.
				  §8056 of the Maine Administrative
				  Procedures Act.
2.2.1 Copies of the federal
				  CLIA standards and certification requirements ( 42 CFR Part 493 ), including
				  the Certificate of Waiver and the Provider Performed Microscopy Certificate
				  requirements, may be obtained from the Department of Health and Human Services,
				  Division of Licensing and Regulatory Services, 11 State House Station, 41
				  Anthony Ave, Augusta, Maine 04333; the Maine Office of the Secretary of State,
				  101 State House Station, Augusta, Maine 04333, or online at
http://www.gpo.gov/fdsys/pkg/CFR-2010-title42-vol5/xml/CFR-2010-title42-vol5-part493.xml
.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-4 - LICENSE APPLICATION AND RENEWAL PROCESS

Current through 2024-29, July 17, 2024
APPLICATION
4.1
Application for license.
Nonexempt medical laboratories must
				  submit a written application for a license on a department-approved form. The
				  application is considered incomplete if the application fee and required
				  documentation are not included. An initial license application is considered
				  incomplete if the Office of the State Fire Marshal's report is not included.
4.1.1 A separate application and application
				  fee must be submitted for each laboratory location.
4.1.2 An applicant for an initial license
				  must secure a report of a satisfactory inspection by the Office of the State
				  Fire Marshal, Maine Department of Public Safety. The cost of an inspection
				  shall be borne by the applicant. The applicant must submit the fire marshal's
				  report to the department with the initial license application.
4.1.3 A copy of the laboratory's CLIA
				  certification must accompany the application for a state license.
4.1.4 If the laboratory has been inspected by
				  CLIA or an accreditation agency a copy of the most recent inspection report and
				  other pertinent documentation prepared by CLIA or an accreditation agency must
				  accompany the application for a state license.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-5 - FEES

Current through 2024-29, July 17, 2024
LICENSE FEES
5.1
Nonrefundable fees.
Fees required by these rules may not be
				  refunded to the applicant or licensee under any circumstances. See
				  22 M.R.S.A.
				  §2020.
5.2
Application fees.
The
				  license application fees are:
5.2.1 $500 for
				  the first category of testing; and
5.2.2 $60 for each additional
				  category.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-6 - LABORATORY OPERATION

Current through 2024-29, July 17, 2024
6.1
Medical
				  laboratory operation.
The operation of medical laboratories must comply
				  with applicable provisions set out in these rules.
6.2
Performance standards.
Medical laboratories are subject to performance standards in accordance
				  with these rules. Performance standards are essential for the achievement of
				  accurate, reliable results and the protection of public health. See
				   22 M.R.S.A.
				  §2023(5).
6.3
Records.
Medical
				  laboratories must maintain laboratory records, including but not limited to
				  reports of laboratory tests. Upon request, laboratory records must be available
				  at all times for inspection by the department. Laboratory records must be
				  retained for 6 years, except when the CLIA record retention requirements
				  establish a lesser or greater time period. See
				   22 M.R.S.A.
				  §2034.
6.4
Physician requested tests.
A
				  medical laboratory shall perform patient testing only at the request of a
				  licensed physician or person authorized by Maine law to request and use the
				  findings of laboratory testing. See
				   22 M.R.S.A.
				  §2030(1).
6.4.1
Exception.
Without a
				  physician's or authorized person's request, a medical laboratory may examine
				  specimens for a limited number of tests including but not limited to the
				  following:
6.4.1.1 Urine pregnancy
				  testing;
6.4.1.2 Cholesterol
				  testing;
6.4.1.3 Colon cancer
				  testing;
6.4.1.4 Fecal occult blood
				  testing; and
6.4.1.4 Glucose
				  testing for persons previously diagnosed with diabetes. See
				   22 M.R.S.A.
				  §2030(2).
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-8 - PROFICIENCY TESTING

Current through 2024-29, July 17, 2024
8.1
Proficiency testing.
Medical laboratories must comply with
				  applicable federal CLIA proficiency testing requirements and state proficiency
				  testing requirements set out in these rules.
8.2
CLIA-approved proficiency testing
				  program.
Proficiency in the performance of the tests offered by the
				  medical laboratory is demonstrated through successful participation in a
				  CLIA-approved proficiency testing program. The medical laboratory must have
				  documentation of enrollment in a CLIA-approved proficiency testing program.
				  Upon request, the laboratory's performance records must be provided to the
				  department. See
				   22 M.R.S.A.
				  §2025.
8.3
Proficiency testing: employee drug
				  testing.
Medical laboratories testing employees and applicants for
				  substances of abuse for employment related purposes must demonstrate
				  satisfactory performance in proficiency testing in compliance with the laws and
				  rules governing Maine Drug Testing Laboratories. See
				   26 M.R.S.A.
				  §§681 -
				  690 and 10 -
				  144 C. M.R. Chapter 265.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-9 - BUILDING AND SAFETY STANDARDS

Current through 2024-29, July 17, 2024
9.1
Building
				  codes.
The laboratory building must comply with applicable state and
				  local plumbing, heating, lighting, ventilation, and electrical codes, and other
				  similar requirements.
				   22 M.R.S.A.
				  §2023(2).
9.2
Specimen collection areas.
Specimen collection areas must comply with the following standards:
9.2.1 Collection areas must have adequate
				  workspace to separate clean and contaminated tasks;
9.2.2 Collection areas must have adequate
				  space for patient seating;
9.2.3
				  Collection areas must have adequate space for washing stations;
9.2.4 Collection areas must be designed to
				  protect patient privacy and confidentiality; and
9.2.5 The urine and feces specimen collection
				  room must be equipped with a lavatory.
				   22 M.R.S.A.
				  §2023(3).
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-10 - INSPECTIONS

Current through 2024-29, July 17, 2024
10.1
Inspection of premises and
				  operation.
The department is authorized to inspect the premises and
				  operation of all medical laboratories, subject to state licensure or any
				  provisions of the Maine Medical Laboratory Act. See
				   22 M.R.S.A.
				  §2024.
10.1.1
Exempt from state
				  inspection.
Medical laboratories are exempt from state inspection if
				  they possess a valid:
10.1.1.1 CLIA
				  Certificate of Compliance; or
10.1.1.2 CLIA Certificate of
				  Accreditation.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES › Section 144-256-TWO-12 - HEALTH SCREENING LABORATORY (HSL)

Current through 2024-29, July 17, 2024
12.1
Health screening laboratory (HSL).
PART TWO of these rules govern
				  health screening laboratories (HSLs) as defined in Section 1.11 of these rules.
12.1.1
Applicable rules.
The
				  purpose, applicable definitions and other provisions in Sections 1 through 11
				  of these rules apply to HSLs.
12.1.2
CLIA certification.
HSLs must be CLIA certified and must comply
				  with the federal CLIA standards, certification requirements and conditions of
				  participation in accordance with Sections 2.1 and 2.2 of these rules.
12.1.2.1 A violation of any of the federal
				  CLIA standards, certification requirements or conditions of participation
				  constitutes a violation of HSL rules.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES › Section 144-256-TWO-13 - HSL PERMIT APPLICATION

Current through 2024-29, July 17, 2024
13.1
Permit
				  application.
Application for a permit must be made on a
				  department-approved form. A permit application is not considered complete until
				  the department receives the application form, required documents, and the
				  application fee, set out in Section 5.6 of these rules.
13.2
Required information.
An
				  application for a permit must include at least the following information:
13.2.1 The HSL owner's name, address and
				  contact information;
13.2.2
				  Location (street and city address) of the HSL event(s);
13.2.3 The HSL's CLIA certification
				  information;
13.2.4 Health
				  screening tests that will be performed;
13.2.5 Name and credentials of personnel who
				  will perform health screening tests and client education;
13.2.6 Identification of each piece of
				  equipment that will be used at the health screening location, including
				  equipment serial number or similar identification;
13.2.7 Written policies and practices to
				  ensure safety during the HSL event including but not limited policies regarding
				  contamination, fire prevention and infection control precautions;
13.2.8 The HSLs health education
				  protocols;
13.2.9 Copies of health
				  education information to be distributed to clients during the HSL event;
				  and
13.2.10 Other information
				  required by the department.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES › Section 144-256-TWO-14 - HSL OPERATION

Current through 2024-29, July 17, 2024
14.1
Itinerary sent to department.
Fourteen (14) business days prior to
				  the earliest scheduled screening event, the department must receive an
				  itinerary of planned HSL events from the permit-holder.
14.1.1
Changes in itinerary.
Notice of any change that is made to an itinerary must be received by
				  the department at least one business day prior to the changed screening
				  event.
14.1.2
Valid use of
				  permit.
The HSL permit is valid only for those HSL events identified on
				  the itinerary and submitted changes received by the
				  department.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES › Section 144-256-TWO-15 - HSL PERFORMANCE STANDARDS AND PERSONNEL

Current through 2024-29, July 17, 2024
15.1
Performance standards.
HSLs
				  must comply with applicable performance standards in Section 6 of these rules
				  and those set out in this section. Performance standards are essential for the
				  achievement of accurate, reliable results and the protection of public
				  health.
15.2
Federal CLIA
				  standards.
HSLs must comply with the federal CLIA standards,
				  certification requirements and conditions of participation in accordance with
				  Sections 2.1 and 2.2 of these rules.
15.2.1 A
				  violation of any of the federal CLIA standards, certification requirements or
				  conditions of participation constitutes a violation of HSL
				  rules.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES › Section 144-256-TWO-16 - HSL RECORDS AND POLICIES

Current through 2024-29, July 17, 2024
16.1
HSL
				  records.
HSL records including but not limited to records of laboratory
				  services and copies of reports of laboratory tests must be kept in accordance
				  with these rules.
16.2
HSL
				  record maintenance and retention.
HSLs must maintain and retain at least
				  the following records and, upon request, make them available for inspection by
				  the department:
16.2.1 Copies of laboratory
				  test reports must be maintained in a confidential manner for a minimum of two
				  (2) years.
16.2.2 Laboratory
				  records including quality assurance, equipment maintenance, and personnel
				  records must be retained for a minimum of two (2) years.
16.2.3 Confidentiality must be maintained
				  when disposing of records.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES › Section 144-256-TWO-17 - HSL QUALITY CONTROL AND PROFICIENCY TESTING

Current through 2024-29, July 17, 2024
17.1
Quality Control
. Quality
				  control must be practiced and documented as a routine part of the HSLs
				  operation.
17.2
Laboratory
				  instruments.
Each HSL instrument must be calibrated for accuracy and
				  linearity according to the manufacturer's instructions.
17.2.1 Each day (24 hour shift) of operation,
				  each instrument must be checked for proper function according to the
				  manufacturer's instructions.
17.2.2
				  Each day (24-hour shift), each instrument must be checked with two different
				  levels of quality control material.
17.2.3 If available, standards and controls
				  must be of the same matrix as client specimen, such as whole blood, serum, and
				  similar specimen.
17.2.4 Acceptable
				  ranges must be established for all aspects of the quality control program.
				  Client test results must not be reported until causes for out of range quality
				  control results have been resolved.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES › Section 144-256-TWO-18 - HSL SAFETY STANDARDS AND INSPECTIONS

Current through 2024-29, July 17, 2024
18.1
Safety.
HSLs must comply
				  with the rules in this section and applicable standards in Section 9 of these
				  rules.
18.2
Laboratory
				  safety.
Applicable OSHA laws must be known and demonstrated by HSL
				  personnel to ensure freedom from unnecessary physical, chemical, biological and
				  electrical hazards.
18.3
Prohibited activity.
Smoking, drinking and eating are prohibited
				  in the HSL work area.
18.4
Infectious material and waste.
Potentially infectious materials
				  and waste must be handled, stored and disposed in accordance with the Maine
				  Department of Environmental Protection, Biomedical Waste Management Rules,
				  06-096 C.M.R. Chapter 900.
18.5
Inspection
. HSLs are subject to inspection at any time testing is
				  offered at a HSL screening location.
18.5.1
Complaints and suspected violations of rules.
HSLs are subject to
				  inspection by the department in response to a complaint or suspected violation
				  of these rules.
18.5.2
Code
				  violations.
HSLs are subject to inspection by the department, or another
				  state agency, or a municipality for suspected violations of building codes,
				  fire codes, life safety codes or for other similar
				  purposes.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES › Section 144-256-TWO-19 - HSL ENFORCEMENT PROCEDURES AND APPEALS

Current through 2024-29, July 17, 2024
19.1
Compliance
. HSL
				  permit-applicants and permit-holders must comply with these rules. HSLs that
				  fail to comply with these rules are subject to the enforcement provisions in
				  this section and applicable provisions in Section 11 of these rules.
19.2
Operating a HSL without a permit:
				  fines or imprisonment.
A person who operates, maintains, directs or
				  engages in the business of operating a HSL without a department-issued permit
				  is in violation of these rules. The performance of any of the acts set out in
				  this section constitutes a crime punishable, upon conviction, by a fine not
				  less than $50 and not more than $500, or by imprisonment for not more than one
				  year, or both.
19.3
Unsupervised HSL: fines or imprisonment.
A person who conducts,
				  maintains or operates a HSL without the direct and responsible supervision and
				  direction of a person possessing the required qualifications is in violation of
				  these rules. The performance of any of the acts set out in this section
				  constitutes a crime punishable, upon conviction, by a fine not less than $50
				  and not more than $500, or by imprisonment for not more than one year, or
				  both.
19.4
Injunction.
The department, through the Office of the Attorney General may, in
				  addition to other available remedies, bring a court action for an injunction to
				  restrain the operation of a HSL that is in violation of these rules or to
				  enjoin the continued operation of a HSL until compliance with these rules is
				  achieved.
19.5
Suspension or
				  revocation of HSL permit.
The department may petition the District Court
				  to suspend or revoke a HSL permit.
19.6
Grounds for suspension or
				  revocation of HSL permit.
Grounds for the suspension or revocation of a
				  HSL permit include but are not limited to the following:
19.6.1 A violation of these rules and
				  applicable laws;
19.6.2 Permitting,
				  aiding or abetting the commission of any illegal act at the HSL;
19.6.3 Conduct or practices detrimental to
				  the welfare of a HSL client;
19.6.4
				  A criminal conviction in any jurisdiction of the HSL medical director or the
				  HSL supervisor arising out of or in connection with the operation of a
				  HSL;
19.6.5 Knowingly lending the
				  use of the name of the HSL or the name of its director to a non-permitted
				  HSL;
19.6.6 Incompetent or
				  unprofessional conduct, including but not limited to:
19.6.6.1 Fabricating results;
19.6.6.2 Unauthorized disclosure of
				  confidential information;
19.6.6.3
				  Willful misrepresentation of results;
19.6.6.4 False or deceptive advertising;
				  or
19.6.7 Making a false
				  or deceptive representation on an application for a department-issued HSL
				  permit.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 257 - SCHEDULE OF CHARGES FOR TESTING AND SERVICES PROVIDED BY THE MAINE HEALTH AND ENVIRONMENTAL TESTING LABORATORY › Section 144-257-1 - PURPOSE

Current through 2024-29, July 17, 2024
Pursuant to
				  22 MRS
				  §565, the Department of Health and Human
				  Services Maine Center for Disease Control and Prevention (Department)
				  establishes this schedule of analytic testing fees and charges for services
				  rendered by the Maine Health and Environmental Testing Laboratory (HETL),
				  including, but not limited to, the chemical and microbiological testing and
				  examination of water supplies, food products, drinking water, and environmental
				  and forensic samples, and the testing and examination of cases and suspected
				  cases of infectious and communicable diseases. The fees specified in this rule
				  apply to all individuals, agencies and providers seeking services conducted by
				  HETL. This rule includes services that the Department deems essential to public
				  health and the criteria for waiving HETL fees. This rule establishes the
				  combination of tests recommended by the Department for residential private
				  drinking water wells and specifies the fees that may be collected for certain
				  drinking water tests pursuant to
				  22 MRS
				  §2660-U.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 257 - SCHEDULE OF CHARGES FOR TESTING AND SERVICES PROVIDED BY THE MAINE HEALTH AND ENVIRONMENTAL TESTING LABORATORY › Section 144-257-3 - ADMINISTRATIVE FEES AND SERVICE CHARGES

Current through 2024-29, July 17, 2024
A.
Adjudication services.
1. Expert
				witness testimony performed by HETL staff
				......................................... $100/hour
2. Discovery requests: When HETL receives a
				discovery request, HETL will assess an administrative fee of $50 for compiling
				the material and providing requested documents. Requests that require lengthy
				or complex responses may result in additional charges based upon the required
				expenditure of HETL resources, including staff time. If it is anticipated that
				the fee will exceed $50, HETL will inform the requester of the estimated
				additional charges and obtain the requester's permission before preparing the
				response to the request.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 257 - SCHEDULE OF CHARGES FOR TESTING AND SERVICES PROVIDED BY THE MAINE HEALTH AND ENVIRONMENTAL TESTING LABORATORY › Section 144-257-4 - FEE WAIVER AND REMITTANCE

Current through 2024-29, July 17, 2024
A.
Service
				fee waiver.
The Department may waive charges for services conducted by
				HETL under certain circumstances. Examples of testing conducted by HETL for
				which the fee may be waived include, but are not limited to, the following
				services, which the Department deems essential to the public health:
1. Laboratory Response Network Bioterrorism
				and Select Agent testing per the HHS and USDA Select Agents and Toxins 7 CFR
				Part 331, 9 CFR Part 121, and 42 CFR Part 73.
2. All required samples submitted in
				accordance with 10-144 CMR, Chapter 258, Rules For the Control of Notifiable
				Diseases and Conditions.
3. Any
				samples assigned an outbreak number by the Department.
4. Rabies specimens for which a public health
				risk exists as determined by an epidemiologist or veterinarian.
5. Serotyping of
Neisseria
				meningitidis
and
Haemophilus influenzae
from sterile
				sites.
6. Confirmation and
				serotyping of
E. coli
,
Salmonella
, and
Shigella
bacterial isolates.
7. Whole genome sequencing of
E.
				coli
,
Salmonella
,
Shigella
,
Campylobacter
, and
Listeria
bacterial
				isolates.
8. Whole genome
				sequencing of bacterial isolates associated with hospital-acquired infections
				submitted with prior authorization from the Department.
9. Whole genome sequencing and subsequent
				metagenomic analysis to determine the potential causative infectious agent(s)
				of an environmental sample submitted with prior authorization from the
				Department.
10. Identification of
				vector borne diseases in mosquitoes and ticks with prior authorization from the
				Department or vector borne biologists.
11. Reverse transcription real-time
				polymerase chain reaction (PCR) for the detection and genotyping of Influenza
				virus.
12. Tuberculosis (TB).
a. All testing on patient samples that are
				submitted with prior authorization from the Department's TB Control
				Program.
b. All testing on patient
				samples identified as mycoplasma tuberculosis complex (MTBC)
				positive.
c. All MTBC rule-out
				testing on specimens submitted for tuberculosis suspects reported to the TB
				Control Program in advance of samples being submitted and who meet the
				Department's TB Control Program's definition for a MTBC suspect.