Adopted rule changes amend 10-144 CMR ch. 265, formerly entitled Drug Testing Laboratory Rules, to be consistent with updates to the Maine Department of Labor's (DOL) best practices and statute (26 MRS ch. 7, subch. 3-A -Substance Use Testing). The adopted rule is consistent with the proposed rule. Changes include: 1) updates to protocols in Section 2 of the rule specific to the collection of hair, oral fluids and sweat patches for drugs; 2) revised cut-off levels for substance-use tests to be consistent with current levels established by the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration; 3) a revised list of proficiency testing programs; 4) updates to testing technology for screening tests; and 5) revised protocols for sample storage. In Section 3 of the rule, the Department amended a reordered list of substances and added the following substances to the list of substances for which an employer may test: buprenorphine, fentanyl, hydrocodone, hydromorphone, oxycodone, oxymorphone, and propoxyphene for urine testing and clarify metabolites, where applicable. Additionally, this rule adoption clarifies the Departments discretionary authority over inspections and, in the definition section of the rule, clarifies confirmed positive result, screening test, and confirmation test. Grammatical and technical corrections, a new title (Substance Use Testing For The Workplace Rule), changes to format and other minor non-substantive changes have been adopted for clarity and conformity to agency standards for improvement of the rule.

The Department has adopted routine technical rule changes that amend Chapter 264, Immunization Requirements for Healthcare Workers, by removing COVID-19 from the list of vaccine preventable diseases for which Designated Healthcare Facility employees must show proof of immunization or provide appropriate exemption documentation. Public comments were considered prior to adopting the final rule. The adopted rule is consistent with the proposed rule published for public comment on July 19, 2023.

The Department amended this rule to update requirements for law enforcement agencies and laboratories involved in testing of persons suspected of operating under the influence of intoxicating liquor or drugs (29-A MRS 2431-2528). The adopted rule is consistent with legislative changes enacted by the 129th Maine State Legislature, impacting certification, sample collection and testing for intoxicating substances. This rule ensures accurate testing for forensic purposes and compliance with applicable rules and standards. Adopted routine technical rule changes include the following:

Revised title from Rules for Sample Collection and Drug Testing in Suspected O.U.I. Cases to Sample Collection and Drug Testing Rule for Suspected Operating Under the Influence Cases; Added definition for Drug Recognition Expert (DRE); Replaced substance of abuse with substance of use; Removed obsolete language and verbiage; Updated accreditation requirements, testing standards, laboratory technical director and analyst qualifications, for quality assurance purposes; Updated reference to the lab's accreditation board, removing ASCLD-LAB and the Society of Forensic Toxicologists (SOFT), the specific names listed in rule for approving bodies of proficiency testing programs. Replaced the term urine drug analysis with toxicology analysis, where applicable; Clarified requirements related to procedure manuals, sample collection and storage, and release of samples; Clarified analysis of blood for alcohol level; and Revised formatting conventions and other minor non-substantive changes to language and grammar. Additionally, in response to public comment, the Department further revised Section 2(A) to clarify that there is flexibility in the settings where qualified persons draw blood, and changed the order of paragraphs (1)(c) and (1)(d) to improve readability. All blood specimens must be collected by a qualified person in a manner consistent with the qualified persons professional training. Urine samples must only be collected in a law enforcement facility or healthcare facility, to protect the individuals privacy. EFFECTIVE DATE: April 3, 2023 AGENCY CONTACT PERSON: Bridget Bagley, Policy Analyst, 11 State House Station, Augusta, Maine 04330. Telephone: (207) 287-9394. Email:.Bridget.Bagley@Maine.gov.

MAINE CDC RULES WEBSITE: http://www.maine.gov/dhhs/mecdc/rules/ MAINE CDC WEBSITE: http://www.maine.gov/dhhs/mecdc/. DHHS WEBSITE: http://www.maine.gov/dhhs/. DHHS RULEMAKING LIAISON: Sara.Gagne-Holmes@Maine.gov.

The Department of Health and Human Services - Maine Center for Disease Control and Prevention (DHHS) adopted routine technical rule changes jointly with the Department of Environmental Protection (DEP) to amend the Maine Comprehensive and Limited Environmental Laboratory Accreditation Rule by establishing a revised fee schedule based on the cost of certifying or accrediting laboratories, pursuant to 22 MRS 567(4). DHHS and DEP amended the rates per test method category, which increased the total biennial accreditation fee, resulting in a $200 rate increase for limited laboratory accreditation (annual or biennial) and a $50 fee for additional methods requested outside of certification. Laboratories subject to this rule will experience a fee increase ranging from 5-50%, depending on the number of methods analyzed. Additional rule changes updated citations for applicable federal regulations from 2017 to the most current year to date (2022), in accordance with 40 CFR Parts 63, 136, 141, 258, 260-261, 264-266, 268, 270-271 and 279, and to allow for the use of the most recently EPA-approved methods-when the alternative method is approved by DHHS and DEP, after the rule is promulgated. Other changes adopted include: 1) adding a reference to. Table IA under the waste water program methods; 2) adding a definition for duplicate and field duplicate; 3) clarifying accrediting body in Section 2 subsection (A)(2)(a); 4) specifying that the written management review and management team meeting will be completed within the first quarter of each calendar year; 5) clarifying that, for the required analytical method SOP, references must include method revision number or letter and publication date; 6) requiring labs that fail a second proficiency test to notify the Maine Laboratory Accreditation Program (MLAP); 7) incorporating enterococcus in the alphabetized list of pollutants for which wastewater discharge facility labs licensed pursuant to 38 MRS 413 may analyze wastewater discharges; and 8) clarifying Section 7 to articulate that a lab may fully accredited for some methods, provisionally accredited for others, and may lose accreditation for methods, all while remaining an "accredited lab". Both Departments also adopted minor grammatical and formatting changes to improve rule clarity and readability.

The adopted rule (1) replaces the term needle with syringe throughout the rule, including the rule title; (2) replaces hypodermic apparatus exchange program with syringe services program; (3) updates the name of the Department's Office of Substance Abuse to Office of Behavioral Health; (4) adds a definition of Syringe Services Program to clarify its purpose to replace Hypodermic Exchange Program; (5) permits Syringe Services Programs to distribute syringes outside of a 1:1 ratio syringe exchange, allowing a Consumer to receive as many clean syringes as the number of syringes the Consumer presents during an Exchange Event and up to a maximum 100 syringes per encounter if the Consumer does not have used syringe(s) to exchange; and (6) permits a Syringe Services Program to further limit the number of syringes dispensed based on policy. The rule format is updated to be consistent with other Maine CDC rules, grammar corrected, and requirements for syringe services programs are further clarified. Additionally, the adopted rule includes the following changes: dispensing limits are clarified in Section (2)(E) and the provision in subsection F specifying that staff names may be provided upon request by law enforcement has been removed .

Expanding Maines 1:1 syringe exchange model to a less restrictive distribution model is supported by research that reports syringe service models based on a clients need may lead to lower syringe re-use and minimize the spread of blood-borne diseases. The Maine CDC is no longer requiring a one-for-one syringe exchange; however, consistent with the emergency rule, the Department is adopting a limit of 100 syringes per encounter when the Consumer does not have the used syringe(s) to exchange (22 MRS 1341(1)(A)). This middle point is intended to strike a reasonable balance between distributing potentially unlimited syringes to any one Consumer per encounter and the previously restrictive 1:1 exchange, a decision that aims to safeguard against depletion of resource and ensure adequate syringes for as many Consumers as possible. The Secretary of State posts the official rule at https://www.maine.gov/sos/cec/

Maine's Newborn Bloodspot Screening Rule (10-144 CMR Ch. 283) is a routine technical rule, except for Section 14 - Fees, which is a major substantive rule provision, pursuant to 5 MRS 8071(3)(B).

On March 11, 2021, the Department implemented Routine Technical and Major Substantive rule changes by emergency rulemaking. The subsequent adoption of Routine Technical rule changes effective June 1, 2021 permanently added four conditions to Maines newborn bloodspot screening panel. Major Substantive rule changes increasing the filter paper fee from $110 to $220 per infant tested were provisionally adopted May 24, 2021. The final adoption of this rule permanently implements the increase to the filter paper fee from $110 to $220 per infant tested, the major substantive portion of the rule. (5 MRS 8073.) The current emergency major substantive rule provision remains in effect up to 60 days after the legislative review and will expire when this final major substantive rule change becomes legally effective. (5 MRS 8072(8).)

The DHHS Maine CDC is adopting updates to align with statutory changes and clarifying requirements for the Dental Care Access Credit Program Rule. These changes include specifying the application-submission deadline, establishing when the applications process ends, outlining the competitive order of receipt process for initial applicants, and extending the certification period for eligible dentists, following the deadline for applications. The Department is also adopting updated responsibilities for certificate holders, further clarifying the Department's notification process of certificate award recipients and updating formatting to align with Maine CDC rulemaking convention.

The Department of Health and Human Services, Maine CDC is adopting changes to the Primary Care Tax Credit Certification Rule, to clarify application requirements and eliminate any reference to specific tax years. These amendments reflect current processes and standards in a clearer way.

The Department of Health and Human Services is statutorily mandated to implement a rule jointly with Maine Health Data Organization for the reporting of data from the cancer-incidence registry established pursuant to 22 MRS sec.1404 and data related to the registration of vital statistics pursuant to 22 MRS sec.2701. The provisions of this new rule include: Identification of the agencies involved and the reporting requirements; establishment of requirements for the content, format, method, and reporting periods for the data; data integration; and confidentiality.

Pursuant to PL 2021, Chapter 423, An Act To Improve Health Care Data Analysis (introduced as LD 541), this rule directs the integration of the cancer registry information and vital statistics data maintained by the Maine CDC into the MHDO data sets, which will enhance the data analysis in the State of Maine, specific to cancer research. The specific types of information collected, processed and/or analyzed under this rule will be subject to release to the public or retained as confidential information in accordance with 22 MRS Chapter sec.1683, 90-590 CMR Chapter 120 and this rule, unless prohibited by state or federal law.

The Department of Health and Human Services - Maine Center for Disease Control and Prevention (DHHS) and the Maine Department of Education (DOE) are jointly adopting these routine technical rule changes to implement P. L. 2019, Ch. 154: An Act to Protect Maine Children and Students from Preventable Disease by Repealing Certain Exemptions from the Laws Governing Immunization Requirements (the "Act"). The Act prohibits the rule from including any provision governing medical exemptions and requires the removal of provisions permitting exemptions from required immunization for school students who object based solely on a sincere religious belief or philosophical reason, except for certain students with an Individual Education Plan (IEP). Effective September 1, 2021, students who may have declined immunizations based on religious or philosophical objection and who are otherwise not eligible for exemptions permitted under Maine's immunization laws, including those enrolled in or attending elementary or secondary schools for pre-kindergarten instruction and students enrolled in school and participating remotely, will be subject to current immunization requirements for the certain specified diseases. The adopted rule includes changes made based on public comment and recommendations by the Office of Attorney General. This rule includes the following amendments: clarification of the requirement for schools to include in their annual report any stricter immunization requirements that may be adopted by ordinance or policy, pursuant to 20-A MRS, 6358 (2), in addition to the immunization status of all students, including immune students, exempt and non-immunized excluded students; revisions to definitions to clarify that school enrollment means adding and maintaining a student to school roster and includes in-person classes and remote learning programs offered by the school; includes immunization requirements specific to pre-kindergarten children; clarification of the dosage requirement for varicella for consistency with US CDC recommendation; clarification of existing authority and responsibility of a superintendent to dismiss or exclude a child from school when there is a public health threat (20-A MRS 6301; 22 MRS ch. 250) and for non-compliance, or when directed by order of a public health official; clarification that the licensed physician, registered nurse practitioner or physicians assistant who provides a medical exemption or the consultation required by this adopted rule for determining a vaccine catch-up schedule for a childs vaccines, be licensed by the State of Maine; and clarification of recordkeeping requirements and attendance tracking for those students who are exempt from immunization requirements. Additionally, for this adopted rule, the proposed exemption for students participating in a distance education program has been withdrawn, due to this proposal being beyond the scope of authority for this rule. Finally, changes also include a revised format of the rule for conformity with Maine CDC rulemaking standards.

The Department is adopting amendments to 10-144 CMR ch. 262, to implement changes required by PL 2019 ch. 154, An Act to Protect Maine Children and Students from Preventable Disease by Repealing Certain Exemptions from the Laws Governing Immunization Requirements (the "Act"), enacted by the 129th Maine Legislature and effective June 16, 2020. The Act prohibits the Department from including any provision governing medical exemptions in this rule. (PL 2019 ch. 154 7.) The Act repeals the exemption from required immunization for post-secondary school students who state a sincere religious belief or philosophical reasons for opposing immunization, effective September 1, 2021. (PL 2019 ch. 154 6.) The adopted rule clarifies the documentation required for students' health records for all students, including immune students, exempt and non-immunized students, and the minimum content for the schools annual report of students immunization status. These rule changes further clarify that this information may be accessed by the Department to ensure compliance with the law and inform measures for controlling the spread of certain diseases. Additionally, this rule amendment clarifies that remote students who do not enter onto school premises are exempt from immunization requirements. In alignment with 20-A MRS 6359(6), nothing in this rule may be construed to preclude the governing board of a public or private post-secondary school from adopting immunization requirements that are more stringent than the provisions set forth in this rule. The final rule adoption also includes proposed minor changes to the rule format and revised title, for consistency with agency standards.

On March 11, 2021 the Department adopted and filed with the Secretary of State's office an emergency Routine Technical/Major Substantive Ch. 283 (Newborn Bloodspot Screening Rule) rule. The emergency major substantive rule changes will be in effect for up to 12 months or until the Legislature has completed its review, as provided by 5 M.R.S. 8072. In this rulemaking, the Department permanently adopts the emergency routine technical rule changes, as shown below, which add four conditions for newborn screening. In addition, the Department provisionally adopts the emergency major substantive rule changes that increase the filter paper fee to $220. The Department will proceed to submit the provisionally adopted major substantive rule changes to the Legislature for its review and approval.

Routine Technical Adopted Rule Changes: The Department expanded the conditions on Maines newborn bloodspot screening panel to include the following conditions to APPENDIX A, Core Conditions, in this rule. These conditions were added on March 11, 2021 by emergency rule for 90 days, pursuant to 5 MRS 8072: Mucopolysaccharidosis Type 1 (MPS-1) Pompe Spinal Muscular Atrophy (SMA) X-linked Adrenoleukpdysrophy (X-ALD)

Early detection and timely diagnosis of certain congenital genetic disorders impact health outcomes for newborns, reducing the mortality and morbidity from certain heritable disorders. Beginning July 1, 2001, Maine began mandatory newborn testing to include nine disorders and, because of the importance of screening, early detection and treatment, and coordination of services for long-term care, the Maine CDC NBSP, with the support of Maines Joint Advisory Committee for Maine Newborn Screening (JAC), has since continued to expand the panel of disorders and revise requirements for screenings for certain conditions to be consistent with the U.S. DHHS Recommended Universal Screening Panel (RUSP). Disorders on the RUSP are chosen based on evidence that supports the potential net benefit of screening, the ability to screen for the disorder, and the availability of effective treatments.

These four conditions were added to the RUSP in the following years: Pompe (2013) MPS-1 (2015) X-ALD (2015) SMA (2018)

The Maine Joint Advisory Committee for Newborn Bloodspot Screening recommended that the Department add Pompe, MPS-1 and X-ALD to the Core Conditions for screening, in October 2018, and in May 2019, the Committee recommended adding SMA.

The Department adopted the four additional conditions to this rule to reduce mortality and morbidity from certain heritable conditions.

Major Substantive Rule Changes Provisionally Adopted: The filter paper fee increase is necessary to off-set anticipated costs corresponding to the added conditions (i.e. genetic clinic contracts, resource material, follow- up services and other related program operations). The emergency adoption of the major substantive rule changes became effective on March 11, 2021. 5 M.R.S. 8002(3-A).

Routine technical rule changes to 10-144 CMR chapter 283, Newborn Bloodspot Screening Rule, have been adopted and are effective June 1, 2021. Major substantive rule change was provisionally adopted on May 19, 2021.

The Department is adopting routine technical rule changes to amend 10-144 CMR ch. 264, Immunization for Healthcare Workers rule, which include (1) Adding and updating references to the statutory authority for the rule; (2) Clarifying, in the Summary, that the rule is purposed to reduce the risk for exposure to and transmission of vaccine-preventable diseases; (3) Updating the definition of Designated Healthcare Facility to clarify the term applies to facilities subject to licensure by the Department; (4) Updating the term Intermediate Care Facility for the Mentally Retarded (ICF/MR) to Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID); (5) Adding definitions for Public Health Emergency, Public Health Threat, and Extreme Public Health Emergency; (6) Removing outdated H1N1 2009-10 reporting language; (7) Adding influenza to the list of vaccine-preventable diseases for which healthcare facilities must require all employees to provide proof of immunization, or immunity, or documentation of an authorized exemption; (8) Adding a description of the Department's authority during a declared Extreme Public Health Emergency, to impose additional disease prevention control measures, including mandatory and mass vaccinations and recommended dosages therefor; and (9) Clarifying that records of Designated Healthcare Facility employee vaccinations must be maintained by the facility for six years following termination.

This routine technical rule amends the Control of Notifiable Diseases and Conditions Rule to: 1) add the following five additional disease conditions: Acute flaccid myelitis, Candida auris, Borrelia miyamotoi, vaping-associated pulmonary illness, and Zika; 2) modify the two listings of multi drug-resistant organisms; 3) remove Staphylococcus aureus (MRSA) from the list; 4) update the human immunodeficiency virus (HIV) testing terminology; 5) clarify authority to access health information, including healthcare information from other entities not specified (e.g. MaineCare), through the state health information exchange; 6) clarify laboratories' electronic reporting requirements (e.g. designated use of HL7 messaging); 7) clarify that when a potentially emerging disease or condition that can cause serious morbidity or mortality and for which the reporting is necessary to monitor, prevent, or control the disease or condition to protect public health, the Department can, through public notice, require immediate reporting for a limited time; and 8) clarify enforcement actions, including referrals to licensing boards and/or the Office of the Attorney General to seek injunctive relief for noncompliance with reporting Category I conditions, specifically, and fine imposition for noncompliance and false reporting. Additionally, the adopted rule includes a change in the proposed frequency for bed occupancy reporting outside of a declared health emergency to allow for weekly reporting and includes additional and revised definitions for epidemic and outbreak. Provisions of this rule ensure that the Department is consistent with national disease reporting recommendations for conditions impacting public health and safety, to ensure timely and accessible information, as diseases and conditions emerge and data needs evolve. Amendments also require designated health care facilities to report information related to emergency preparedness and responsiveness.

The DHHS, Maine CDC is adopting an update to the schedule of charges for testing and services provided by the Maine Health and Environmental Testing Laboratory (HETL), including, but not limited to the following: chemical and microbiological testing and examination of surface water sources, food products, public and private drinking water well samples, and environmental and forensic samples; the examination of cases and suspected cases of infectious and communicable diseases; and other public health services required by the recently revised 22 M.R.S. Chapter 601. This rule repeals and replaces 10-144 C.M.R. Chapter 257 and repeals 10-144 C.M.R. Chapter 233. This rule establishes a fee schedule for testing and services performed by HETL based on the average cost of providing the service and serves to: 1) Update the charges for analytical testing, including chemical, microbiology, water quality, environmental, radiation, lead, and forensic testing, and other public services performed by HETL according to a rate setting methodology to determine the average cost of the service; 2) Set the additional charge of $2 that may be applied to the cost for residential private drinking water well test orders; 3) Establish administrative charges for licensing, manual data entry for all clinical submissions not sent electronically, and collection of overdue payment; 4) Amend the list of testing services available (i.e., add new tests and services and remove certain tests and services no longer available through HETL); 5) Specify the Department's uniform recommendations for periodic testing of residential private drinking water wells in written outreach material; 6) Require labs to submit electronic orders to HETL and use HL7 messaging, as of January 2022; 7) Clarify the types of services deemed essential to public health; and 8) Clarify considerations for granting fee waivers.

Pursuant to 22 M.R.S. 820(1)(C), this is a major substantive rule. Pursuant to Resolve 2021, ch. 51, the Department of Health and Human Services (Department) finally adopts this new major substantive rule, 10-144 C.M.R. chapter 124, Emergency Medical Services Personnel Reporting Rule.

On April 22, 2020, the Department adopted an emergency major substantive rule, which, per 5 M.R.S. 8073, was effective one year, through April 21, 2021. The Department then proposed a major substantive rule. After the comment period, the rule was provisionally adopted and submitted to the Legislature for its review pursuant to 5 M.R.S. 8072. Resolve ch. 51 authorized final adoption of this rule and directed that immediate enactment of the Resolve was necessary, and therefore directed that the Resolve took effect when approved. The Resolve was approved by the Governor on June 11, 2021. In accordance with 5 M.R.S. 8072(8), the Department has finally adopted this rule within 60 days of the effective date of the legislation approving this rule.

Through its authority in 22 M.R.S. 820(1)(C), the Department is establishing a uniform system of reporting requirements, to enable statewide surveillance of the response capacity of the State of Maine's healthcare workforce, specifically emergency medical service (EMS) personnel, during a declared Extreme Public Health Emergency (22 M.R.S. 802(2-A)). This rule ensures the Departments continued coordination and integration of activities and resources related to emergency medical services, to inform the overall planning, evaluation, coordination, facilitation and operations of an effective comprehensive statewide emergency medical services system.

This rule requires EMS organizations and emergency medical dispatch (EMD) centers to report information about EMS personnel who, during a declared Extreme Public Health Emergency, have been removed from the workforce temporarily because they have been exposed to a Notifiable Disease or Condition, or because they have developed symptoms of a Notifiable Disease, in accordance with the guidance issued by the Department, in partnership with the Department of Public Safety Maine EMS. Under this rule, EMS organizations and EMD centers are responsible for compliance with electronic reporting. Reporting must be completed within 24 hours of when the EMS personnel is removed from service. Reporting of certain subsequent events must also be completed within 24 hours. Information collected specific to EMS personnel, which includes licensed emergency medical service responders, emergency medical transportation services and dispatch, will be used for public health surveillance purposes and will inform decisions regarding healthcare workforce capacity as a key element of a comprehensive and effective emergency medical services system. Accurate and reliable statewide data is essential for coordinating with municipal localities, other State offices, federal emergency management agencies and healthcare systems across the State, in order to prepare for and respond to public health emergency needs.

This emergency amendment allows Department-certified Syringe Services Programs to implement a needs-based distribution model instead of requiring syringes to only be exchanged on a one-to-one basis. Pursuant to 5 MRS 8054, and as further set forth in the Basis Statement, the Department finds that the emergency adoption of 10-144 CMR Ch. 252 is necessary to avoid an immediate threat to public health, safety or general welfare and to comply with PL 2021 ch. 545, An Act to Amend Syringe Services Programs, which became effective on August 8, 2022. This adopted emergency rule is effective September 1, 2022.