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-11 - ENFORCEMENT AND APPEALS

Current through 2024-29, July 17, 2024
11.1
Compliance
. Applicants and licensees must comply with these
				  rules.
11.2
Operating 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.
11.3
Unsupervised 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.
11.6
Grounds 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.