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General Laws

Section 5. Any person seeking a license to maintain a clinical laboratory apart from a hospital or clinic licensed under section fifty-one of chapter one hundred and eleven shall file with the department a license application containing such information as the department may reasonably require, including but not limited to the identity of the applicant and any parent or associated company, the identity and qualifications of the proposed laboratory director, and the procedures or categories of procedures for which the license is sought.

Upon receipt and review of an application for license and upon payment of the appropriate fee, the department shall issue a license if it finds that the applicant is responsible and suitable to maintain a clinical laboratory and meets such requirements as the department has established by regulation for a license. In the case of renewal application, the department may, subject to such regulations as it shall make, issue a provisional license to an applicant who does not meet every requirement for a license; provided, that the applicant has demonstrated to the department’s satisfaction a good faith intention to correct deficiencies, and provided further, that the department finds that the licensee provides reliable reports of examinations of specimens and presents satisfactory evidence that the requirements for full licensure can and will be met within a period of time not to exceed six months. The department shall in no case issue a person more than two consecutive provisional licenses for the same clinical laboratory.

The department shall set forth in every license issued under this section the name and address of the licensee; the name by which the clinical laboratory shall be known; the address of the licensed premises; the period which such license is issued; the classification, if any, for which such license is issued; the conditions as to transfer and assignment prescribed by law; and such other terms of issuance as the department may reasonably prescribe. The period of a full license shall be not more than two years and the period of a provisional license shall be for not more than six months.

No licensee shall transfer the license issued him, or assign any authority granted thereunder, in any manner voluntarily or involuntarily, directly or indirectly, or by transfer or control of any person, without first obtaining the department’s written permission, upon application to the department. Every application therefor shall contain such information as the department may require, and shall be approved or denied within sixty days of filing with the department. The department shall grant written permission if the department finds that the transferee or assignee is responsible and suitable to maintain a clinical laboratory and meets such requirements as the department has established by regulation for a license. Every denial order shall include a statement of the reasons for denial and the provisions of law relied upon, and shall be subject to judicial review.

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