10-144-256 Me. Code R. § ONE-11

Current through 2024-51, December 18, 2024

Section 144-256-ONE-11 - ENFORCEMENT AND APPEALS

11.1Compliance. Applicants and licensees must comply with these rules.

11.2Operating an unlicensed nonexempt laboratory. It is unlawful for a person to operate, maintain, direct or engage in the business of operating a medical laboratory unless the person has obtained a medical laboratory license from the department. The performance of any act 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. See 22 M.R.S.A. §§2037(1) and 2038.

11.3Unsupervised laboratory. It is unlawful for a person to conduct, maintain or operate a medical laboratory unless the medical laboratory is under the direct and responsible supervision and direction of a person possessing the required qualifications as set out in these rules. The performance of any act 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. See 22 M.R.S.A. §§2037(2) and 2038.

11.4 Injunction. In addition to other available remedies, the department through the Office of the Attorney General may bring an action for an injunction to restrain violations of these rules or to enjoin the continued operation of a medical laboratory. See 22 M.R.S.A. §2039.

11.5 Suspension or revocation of license. The department may petition the District Court to suspend or revoke a state-issued medical laboratory license. Before the Court renders a decision, the license-holder may be heard to show cause why a license should not be suspended or revoked. See 22 M.R.S.A. §2036.

11.6Grounds for suspension or revocation of license. Grounds for the suspension or revocation of a state issued license include but are not limited to the following:

11.6.1 Violation of these rules and applicable laws;

11.6.2 Permitting, aiding or abetting the commission of any illegal act at the laboratory;

11.6.3 Conduct or practices detrimental to the welfare of a client;

11.6.4 The conviction of the laboratory owner or director of a Class A, B or C crime or a similar crime in any jurisdiction;

11.6.5 The conviction of the laboratory owner or director of any crime arising out of, or in connection with, the operation of a medical laboratory; See 22 M.R.S.A. §2035;

11.6.6 Knowingly lending the use of the name of a licensed medical laboratory or its director to an unlicensed medical laboratory;

11.6.7 Knowingly accepting from an unauthorized person an assignment for medical laboratory tests or specimens from and the rendering of a report of those test results to the unauthorized person; See 22 M.R.S.A.20352 );

11.6.8 Incompetent or unprofessional conduct, including but not limited to:

11.6.8.1 Fabricating results;

11.6.8.2 Unauthorized disclosure of confidential information;

11.6.8.3 Willful misrepresentation of results;

11.6.8.4 False or deceptive advertising; or

11.6.9 Making a false or deceptive representation on an initial application or renewal form for a state issued medical laboratory license.

11.7 Emergency suspension or revocation of license. When the department finds conditions exist that, in the opinion of the department, immediately endanger the health or safety of patients or otherwise create an emergency, the department may petition the District Court to immediately suspend or revoke the license. See 4 M.R.S.A. §184(6).

11.8 Appeal. Any person aggrieved by a 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.

10-144 C.M.R. ch. 256, § ONE-11