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 2024-38, September 18, 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.

19.7 Emergency suspension or revocation of HSL permit. When the department finds conditions exist that, in the opinion of the department, immediately endanger the health or safety of clients or otherwise create an emergency, the department may petition the District Court to immediately suspend or revoke the HSL permit.

19.8 Appeal. Any person aggrieved by the final agency action of the department may file an appeal with the District Court pursuant to Title 5, chapter 375 of the Maine Revised Statutes. See 22 M.R.S.A. §2040.

Disclaimer: These regulations may not be the most recent version. Maine may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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