10-144-256 Me. Code R. § ONE-4

Current through 2024-51, December 18, 2024

Section 144-256-ONE-4 - LICENSE APPLICATION AND RENEWAL PROCESS

APPLICATION

4.1Application for license. Nonexempt medical laboratories must submit a written application for a license on a department-approved form. The application is considered incomplete if the application fee and required documentation are not included. An initial license application is considered incomplete if the Office of the State Fire Marshal's report is not included.

4.1.1 A separate application and application fee must be submitted for each laboratory location.

4.1.2 An applicant for an initial license must secure a report of a satisfactory inspection by the Office of the State Fire Marshal, Maine Department of Public Safety. The cost of an inspection shall be borne by the applicant. The applicant must submit the fire marshal's report to the department with the initial license application.

4.1.3 A copy of the laboratory's CLIA certification must accompany the application for a state license.

4.1.4 If the laboratory has been inspected by CLIA or an accreditation agency a copy of the most recent inspection report and other pertinent documentation prepared by CLIA or an accreditation agency must accompany the application for a state license.

4.2Information on application. The application must contain at least the following information:

4.2.1 The name and location of the medical laboratory:

4.2.2 The name of the owner or owners of the laboratory;

4.2.3 The name of the director of the laboratory;

4.2.4 A description of the services provided by the laboratory; and

4.2.5 Other information required by the department. See 22 M.R.S.A. §2016.

ISSUED LICENSE

4.3Issuance of license. After a review of the application and required documents, the department issues a license to an applicant if the information submitted by the applicant demonstrates satisfactory evidence of compliance with applicable federal CLIA requirements and these rules.

4.3.1Location licensed. The department issues a separate license for each location.

4.3.2License issued to owner and director jointly. When the owner is not the director, the department issues the license jointly to the owner and the director for the premises stated in the application. They are severally and jointly responsible to the department for the maintenance and conduct of the licensed medical laboratory and for any violations of these rules. See 22 M.R.S.A. §2018.

4.3.3Limited license issued to a laboratory that performs only CLIA waived tests. Medical laboratories that perform only tests categorized as waived by CLIA are issued a limited license to perform only those waived tests for which the supervisor is qualified.

4.3.4Information on a license. The issued license must include at least the following information:

4.3.4.1 The name of the laboratory director;

4.3.4.2 The official name and address of the laboratory;

4.3.4.3 The testing specialties and categories certified by CLIA;

4.3.4.4 The effective date and the expiration date of the issued license; and

4.3.4.5 Other information required by the department.

4.4Inspections. Maintenance of state licensure is contingent on successful compliance with initial and subsequent on-site inspections required by the medical laboratory's CLIA certification type and conducted by CLIA or its agent. See 42 C.F.R. Part 493, Subpart Q. Loss of CLIA certification results in loss of state license.

4.5Term of license. The term of the license is three (3) years from the date of issuance. See 22 M.R.S.A. §2017.

4.6New location, director or owner: new license. A new license, for the unexpired length of time of the original license, may be secured when there is a new location, director or owner. The new license must be obtained prior to the actual change and the change must comply with these rules. See 22 M.R.S.A. §2018. The licensee may obtain the new license upon payment of the fee set out in Section 5.4 of these rules.

4.7Duplicate license. A licensee may obtain a copy of a current license upon payment of the fee set out in Section 5.5 of these rules. See 22 M.R.S.A. §2022.

4.8Failure to renew license. If a license is not renewed, it expires on the expiration date and operation of the medical laboratory must cease.

RENEWAL OF LICENSE

4.9Department notice to renew license. Sixty (60) calendar days prior to the expiration of a license, the department shall send licensees a notice that their license must be renewed with a department-approved renewal form. The department notice may be sent electronically.

4.10Renewal of license30 days prior to expiration. Completed department-approved renewal forms must be received by the department with the renewal fee and required documentation at least thirty (30) calendar days prior to the expiration date of the license. The renewal request is considered incomplete if the renewal fee and required documentation are not submitted with the renewal form.

4.10.1Renewal process. Licenses are renewed in the same manner and subject to the same conditions as the issuance of the original license and upon payment of a renewal fee. See 22 M.R.S.A. §2017.

4.10.2Renewal documentation. With the completed department-approved renewal form, the licensee must submit at least the following information:

4.10.2.1 A copy of the most recent inspection report and other pertinent documentation prepared by CLIA or its agent, or an accreditation agency; and

4.10.2.2 Other information required by the department.

REFUSAL TO ISSUE OR RENEW A LICENSE

4.11 Refusal to issue or renew a license. The department may refuse to issue or renew a state-issued medical laboratory license, based on any of the following criteria:

4.11.1 Misrepresentation, materially incorrect or insufficient information on the license application or renewal form;

4.11.2 The premises do not meet the requirements for issuing or renewing a license;

4.11.3 The designated laboratory director does not meet CLIA requirements;

4.11.4 Failure to comply with any of these rules;

4.11.5 Knowingly accepting an assignment for medical laboratory tests or specimens from, and rendering a report to, persons not authorized by law to submit specimens;

4.11.6 Conviction of a Class A, B or C crime or a similar crime in other jurisdictions;

4.11.7 Conviction of any crime under the laws of any state or the United States arising out of or in connection with the operation of a medical laboratory; or

4.11.8 Knowingly lending the use of the name of a licensed medical laboratory or its director to an unlicensed medical laboratory. See 22 M.R.S.A. §2035.

SUSPENSION or REVOCATION

4.12Suspension or revocation of license. The department may suspend or revoke a medical laboratory's license in accordance with Section 11.5 of these rules.

10-144 C.M.R. ch. 256, § ONE-4