Section 127.037 - Enforcement Procedures(A)Notice of Violation. Whenever the Department finds upon inspection, investigation of a complaint or through information in its possession that an applicant or licensee is not in compliance with provisions of M.G.L. c. 111, §§ 5N through 5Q or a regulation promulgated thereunder, the Department shall notify the applicant or licensee of such violation or deficiency. The notice shall include a statement of the violations or deficiencies found, the provision of the law relied upon, and a reasonable period of time for correction. A violation or deficiency may result in denial, suspension, revocation or refusal to renew a license or certificate of inspection; a modification or limitation of a license; a cease and desist order; and/or the imposition of a civil penalty and/or criminal sanctions.(B)Plan of Correction.(1) The applicant or licensee shall within ten days of receipt of the notice, file with the Department a written plan of correction. The plan shall clearly identify the licensee, state the date, reference the violation or deficiency cited, state specific corrective action(s) and timetable(s) and date(s) for completion for each deficiency cited, and shall be signed by either the applicant or licensee or his or her designee.(2) The Department may reinspect a facility in order to determine whether the corrections have been made. If upon review of plan of correction and/or reinspection the Department finds that the applicant or licensee is in compliance with 105 CMR 127.000 and/or that the applicant or licensee has submitted an acceptable plan of correction, the Department shall notify the applicant or licensee of its findings of compliance and/or its acceptance or modification of the plan of correction.(3) If upon review of plan of correction and/or reinspection the Department finds the plan of correction is unacceptable, the Department may request that the applicant or licensee amend and resubmit the plan of correction with five days of the date of notice or such other time as the Department may specify for resubmission.(4) If upon review of the plan of correction and/or reinspection the Department determines that an applicant or licensee remains noncompliant with applicable laws and regulations regarding licensure, the Department may initiate enforcement procedures as set forth in 105 CMR 128.037(C).(C)Notice of Department's Intent to Issue an Order. (1) Prior to the Department issuing an order to modify, limit, deny, revoke or refuse to renew a license, and/or to require a person to cease and desist any activity, and/or to impose civil penalties, the applicant or licensee shall be notified in writing of the grounds for the Department's action, the provision(s) of law relied upon, the amount of any civil penalty, and his or her right to request an adjudicatory proceeding and/or judicial review.(2) If a license is to be denied, modified, limited, revoked or refused renewal or if an activity is to be ceased or a civil penalty imposed by the Department, then the aggrieved applicant or licensee may request an adjudicatory hearing within 21 days of receipt of notification of the Department's Intent to Issue an Order. Said request shall be filed in accordance with Standard Adjudicatory Rules of Practice and Procedures, 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedures.(D)Administrative Hearings: Procedure.(1)Suspension of a License or Immediate Cessation of Activity.(a) The Department shall give the licensee written notice stating the reason(s) for the suspension or immediate cessation of an activity and the provisions of law relied upon. The suspension or order of immediate cessation of an activity shall take effect immediately upon issuance of the notice.(b) The Department shall provide for a hearing pursuant to 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedures promptly after the issuance of an order of suspension or order of immediate cessation of an activity.(c) In cases of suspension of a license or immediate cessation of an activity, the Hearing Officer shall determine whether the Department has proved by a preponderance of the evidence that there existed, immediately prior to or at the time of the suspension or cease and desist order, a threat to public health, safety or the environment.(d) In the event that the Department determines that the violation of state law or of 105 CMR 127.000 which posed a threat is corrected prior to the decision of the Hearing Officer, the Department may lift the suspension by giving written notice to the mammography facility.(2)Denial, Modification, Limitation, Revocation, or Refusal to Renew a License Based on Failure to File Reports or Pay Fees or Maintain Insurance. No hearing shall be afforded where denial, modification, limitation, revocation, suspension or refusal to review is based solely upon failure of the licensee to file timely reports, schedules or applications or to pay lawfully proscribed fees, or to maintain insurance coverage as required by any law or regulation. M.G.L. c. 30A, § 13(3).(3)Denial, Modification, Limitation, Revocation or Refusal to Renew a License; Orders to Cease an Activity; Civil Penalties. (a) All adjudicatory proceedings shall be conducted in accordance with M.G.L. c. 30A and 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedures.(b) Except for circumstances specified in 105 CMR 127.037(D)(2), if the Department determines that a license should be denied, modified, limited, revoked, or refused renewal, and/or that a mammography facility should cease an activity, and/or that a civil penalty should be imposed, and if the Department notifies the applicant or licensee of its intended action, upon receipt of a Notice of Claim for an Adjudicatory Proceeding, the Department shall initiate a hearing pursuant to 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedures.(c) The Hearing Officer shall determine whether the Department has proved by a preponderance of the evidence that the license should be denied, modified, limited, revoked or refused renewal; that an activity should be ceased; and/or that a civil penalty be imposed based on relevant facts as they existed at or prior to the time the Department initiated the hearing procedure.(d) If the Hearing Officer finds any single ground for denial, modification, limitation, revocation, suspension, or refusal to renew a license; for a cessation of an activity; and/or for imposition of a civil penalty, then the Hearing Officer shall render a recommended decision affirming the issuance of the Department's Order.(4)Final Agency Decision and Judicial Review.(a) The recommended decision of a Hearing Officer in any adjudicatory proceeding conducted under 105 CMR 127.000 shall be reviewed by the Commissioner. The Commissioner's decision upon this review shall constitute a final agency decision in an adjudicatory proceeding subject to judicial review pursuant to M.G.L. c. 30A, § 14.(b) Any applicant or licensee that fails to exercise its right to an adjudicatory proceeding under 105 CMR 127.000 waives both its right to administrative review by the Commissioner and its right to judicial review pursuant to M.G.L. c. 30A, § 14.(E)Civil Penalties. (1) If the Department determines, after a notice has been issued and an opportunity for a hearing has been provided, that a mammography facility has not complied with an order issued pursuant to M.G.L. c. 111, § 50 or with any provision of M.G.L. c. 111, §§ 5N through 5Q or with any applicable rule, regulation, license or registration adopted or issued thereunder, the Department, in lieu of, or in addition to suspending, denying, modifying, limiting, revoking, or refusing renewal of a license, may assess civil penalties in an amount not exceeding $ 100,000 per violation. Such civil penalty may be assessed whether or not the violation was willful.(2)Factors in Determining Amount of Penalty. In determining the amount of the civil penalty, the Department shall consider the following:(a) The willfulness of violation;(b) The actual and potential danger to the public health or the environment;(c) The actual or potential cost of such danger to the public health or the environment;(d) The actual or potential damage or injury to the public health or environment;(e) The actual and potential cost of such damage or injury;(f) The actual or potential cost to the Commonwealth of enforcing provisions of 105 CMR 127.000;(g) Whether the person being assessed the civil penalty did everything reasonable to prevent failure to comply from occurring, to come into compliance promptly, and to remedy and mitigate whatever harm might have been done as a result of the failure to comply;(h) Whether the person being assessed the civil penalty has previously failed to comply with any order issued pursuant to M.G.L. c. 111, §§ 5N through 5Q or any other rule or regulation adopted hereunder;(i) Whether imposition of a civil penalty is likely to deter future noncompliance;(j) The financial condition of the person being assessed the civil penalty; and(3)Civil Penalty for Operation without a License. Operation of a mammography facility without a license constitutes a violation of law punishable by a civil penalty of up to $100,000. Each day during which a mammography facility operates without a license shall constitute a separate offense.(4)Payment of the Civil Penalty. If after hearing, or waiver thereof, the Department imposes a civil penalty then the civil penalty shall be due and payable to the Commonwealth of Massachusetts on the 30th day after final agency action.(5)Non-exclusivity of Civil Penalties. By imposing a civil penalty, the Department does not waive its right to invoke other enforcement procedures, such as modification, limitation, suspension, revocation or refusal to renew a license, registration or certificate of inspection.(F)Criminal Enforcement. The Department may elect to enforce any section of 105 CMR 127.000 or provision of M.G.L. c. 111, § 5P by seeking to have criminal sanctions imposed. Any person who violates M.G.L. c. 111, § 5N or 50 or any rule, regulation, license, registration, or order adopted or issued under M.G.L. c. 111, § 5N or 50 shall be fined not less than $100,000 nor more than $200,000, or be imprisoned for a period of not more than two years, or both. Any person who continues to violate the provisions of the aforementioned laws after due notice by the Department shall be fined not less than $1,000 nor more than $20,000 or be imprisoned for a period of not more than 20 years, or both. After due notice has been issued by the Department, each day of such violation shall constitute a separate offense.(G)Judicial Enforcement. The Department may apply directly to the Supreme Judicial Court or Superior Court to enforce any provision of M.G.L. c. 111, §§ 5N through 5Q and/or any rule or regulation, license, registration, or order adopted and issued thereunder by the Department. When a person is engaged in or about to engage in any act or practice which constitutes or will constitute a violation of such provision, rule, regulation, license, registration, or order, the Department may seek to restrain such act or practice or the use or occupation of premises or parts thereof or such other equitable relief as public health and safety requires.(H)Non-exclusivity of Enforcement Procedures. None of the enforcement procedures contained in 105 CMR 127.000 are mutually exclusive. Any enforcement procedures may be invoked simultaneously if the situation so requires.Amended by Mass Register Issue 1368, eff. 6/29/2018.