Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
Section 180.035 - Enforcement Procedures

(1) Whenever the Department finds upon inspection or through information in its possession that a clinical laboratory licensed or approved pursuant to c. 111D is not incompliance with a provision of M.G.L. c. 111D or a regulation promulgated thereunder, it may order the licensee or approved entity to correct such deficiency. The correction order shall include a statement of the deficiencies found, the provisions of law relied upon, and the period prescribed for correction, which shall be reasonable and, except in an emergency declared by the Commissioner, not less than 30 days after receipt of such order.

(2) The Department shall notify the licensee or approved entity of his right to administrative reconsideration of the correction order. The licensee or approved entity may within ten days of receipt of the order, file a written request with the Department for administrative reconsideration. The request shall clearly identify the licensee or approved entity, state the date and nature of the order, state the reason why the order should be rescinded or modified and shall be signed by either the licensee or approved entity or the director employed by the licensee or approved entity.

(3) The Department shall have ten days after receipt of the reconsideration request to act upon the request. Failure of the Department to grant, deny or otherwise act upon a reconsideration request within ten days after filing shall be deemed a denial.

(4) Upon expiration of a correction order, the Department may reinspect the clinical laboratory in order to determine compliance by the laboratory with the correction order. If the Department makes a determination of substantial non-compliance with the correction order, the Department may issue a Notice of Sanctions to the clinical laboratory. The Notice of Sanctions shall be subject to the procedures set forth in 105 CMR 180.035(C).

(1) The Department may order modification of a license or approval issued to a clinical laboratory if upon inspection or through other information in its possession, it determines that the laboratory is not able to or is not providing reliable reports of examinations pursuant to the terms of the license or approval. The license or approval modification order shall be for the purpose of enabling the laboratory to provide reliable reports and shall include a statement of the reasons for modification, the provisions of law relied upon and the date fixed for compliance, which shall be reasonable and, except in an emergency declared by the Commissioner shall be not less than 30 days after receipt of the order.

(2) The Department shall notify the licensee or approved entity of his right to an adjudicatory hearing under the provisions of M.G.L. c. 30A. The licensee or approved entity may file a written request for a hearing within 30 days of receipt of the notice or the right to a hearing shall be deemed to have been waived.

(3) The filing of a request for a hearing shall not operate as a stay of the compliance date of a license or approval modification order, but the Department shall stay the compliance date upon written request, except to the extent that a stay would jeopardize the public health or public safety. If after hearing the licensee or approved entity establishes that the order, or any portion thereof, is not warranted, the Department shall rescind or qualify the order as appropriate.

(1) The Department may revoke the license or approval issued under M.G.L. c. 111D, § 5 or impose other appropriate administrative sanction upon a license or approval, or both, for conduct by or chargeable to him as follows:

(2) Prior to sanctioning a license or approval, the Department shall give the licensee or approved entity notice of the proposed action, notice of the charges against him, the provisions of law relied upon, and shall afford him the opportunity for a hearing under the provisions of M.G.L. c. 30A. The licensee or approved entity may file a written request for a hearing within 30 days of receipt of the notice or the right to a hearing shall be deemed to have been waived.

(3) If, after hearing, the Department finds that cause exists for imposition of a sanction, it may impose a lesser sanction than the proposed sanction if the lesser sanction is appropriate in the circumstances. Lesser sanctions may include, but shall not be limited to, either singularly or in combination: license or approval suspension, license or approval modification and fines. Fines imposed shall be in accordance with a schedule published by the Department which shall be available to the licensee or approved entity. In the event revocation is imposed, the licensee or approved entity shall be permitted a reasonable period to cease operation, but in no case less than 30 days after notice from the Department. In the event no timely appeal of the proposed sanction is file d by the licensee or approved entity, the proposed sanction shall be imposed as the final decision of the Department.

(1) The Commissioner may, at any time upon notice to the licensee or approved entity, whether a hearing has been first commenced or not, suspend his license or approval or issue such other preliminary order as the Commissioner considers appropriate for the protection of the health or safety of the public if he should find that either is in jeopardy.

(2) A hearing pursuant to M.G.L. c. 30A shall be commenced within five days after such notice in any case of suspension without a prior hearing unless the licensee or approved entity shall request a postponement. The notice from the Commissioner shall include the charges against the licensee or approved entity, the provisions of law relied upon, the finding of the Commissioner and the date upon which the hearing shall commence.