Title 22, Title 22

Application must be made on a form prescribed by the department. Licenses must be issued to perform testing in one or more of the following categories or specialties: Histocompatibility; microbiology, including subcategories bacteriology, mycology, parasitology, virology; immunol…

A license shall expire 3 years after the date of issuance unless renewed. Licenses may be renewed in the same manner and subject to the same conditions as the issuance of the original license and upon payment of a renewal application fee of $200 for the first category and $60 for…

A license to conduct a medical laboratory when the owner is not the director shall be issued jointly to the owner and the director for the premises stated in the application, and they shall be severally and jointly responsible to the department for the maintenance and conduct the…

A person maintaining, conducting or operating a medical laboratory shall display, in a prominent place in the medical laboratory, the license issued to the person by the department. A medical laboratory may not in any advertisement, announcement, letter, circular, poster, sign or…

Fees required under this Act may not be returned to the applicant or licensee under any circumstances.

All fees charged and collected by the department shall be deposited by it in the State Treasury to the credit of the department. All such money is appropriated to be used by the department in carrying out this Act. The expenditures of the department may be paid from that money.

A licensee may obtain a duplicate copy of the license upon payment of $2 to the department.

The department shall prescribe and publish rules and regulations for medical laboratories. These rules and regulations shall relate to: [PL 1993, c. 600, Pt. B, §8 (AMD).] 1. Qualifications of directors and technical personnel. The qualifications of directors and technical person…

The department shall adopt a schedule of fees by rulemaking to implement provisions of this chapter.

The department is authorized to inspect the premises and operations of all medical laboratories, subject to licensure or any provisions under this Act.

The department shall require the demonstration of proficiency in the performance of the tests offered by laboratories subject to licensure or the provisions of this paragraph through successful participation in a proficiency testing program acceptable to the department covering a…

Every medical laboratory shall have a director who is a legal resident of the State of Maine, except under certain conditions which may be designated by the department. The director shall also possess one of the following qualifications: [PL 1993, c. 600, Pt. B, §14 (AMD).] 1. Ce…

1. Request from authorized person. Except as otherwise provided, a medical laboratory shall examine specimens only at the request of a licensed physician or other person authorized by law to use the findings of laboratory examinations. 2. Exceptions. Notwithstanding this section,…

The result of a test must be reported directly to the licensed physician or other person authorized by law who requested it. A report of results issued from a medical laboratory must clearly identify that medical laboratory and the director.

A medical laboratory that performs services under this Act shall send an itemized billing statement to the patient.

The following persons may collect or process specimens: licensed health care professionals; designees of licensed health care professionals acting within their scope of practice; and qualified medical laboratory personnel who are authorized by the director of the medical laborato…

The owner or director of a laboratory licensed under this Act, either personally or through an agent, may not practice in any manner that offers or implies to offer rebates to persons submitting specimens or other fee splitting inducements or participate in any fee splitting arra…

Records involving laboratory services and copies of reports of laboratory tests shall be kept in a manner satisfactory to the department and shall be available at all times for inspection by its representative.

A license may be denied or revoked or the renewal of a license may be denied for any of the following reasons: [PL 1975, c. 218 (RPR).] 1. Violation of Act. Violation of any of the provisions of this Act or the rules and regulations promulgated by the department hereunder; 2. Ass…

Before suspension or revocation of its license, if requested, a hearing must be held to show cause why a license should not be suspended or revoked.

It is unlawful for any person to: [PL 1975, c. 218 (RPR).] 1. Unlicensed. Operate, maintain, direct or engage in the business of operating a medical laboratory, as defined, unless the person has obtained a medical laboratory license from the department; or 2. Unsupervised. Conduc…

The performance of any of the acts specified in section 2037 shall constitute a misdemeanor punishable, upon conviction, by a fine of not less than $50 nor more than $500, or by imprisonment for not more than one year, or by both.

The operation or maintenance of a medical laboratory subject to licensure or any provisions of this Act, in violation of this Act, is declared a nuisance inimical to the public health, welfare and safety. The department, in the name of the people of the State, through the Attorne…

Any person aggrieved by a decision of the department may appeal to the District Court Judge under Title 5, chapter 375.