Current through 2024-52, December 25, 2024
Section 144-114-8 - Enforcement8.1 Immunity.A person who in good faith reports a near miss event, a suspected sentinel event or a sentinel event or provides a RCA pursuant to these rules is immune from any civil or criminal liability for the act of reporting or participating in the review conducted by the SET. 8.1.1 "Good faith" does not include instances when a false report is made and the person reporting knows the report is false. These rules may not be construed to bar civil or criminal action regarding perjury or regarding the sentinel event that led to the report.8.2 Failure to comply with applicable laws and rules. Failure to comply with these rules may result in an enforcement action including but not limited to the imposition of a financial penalty as set out in these rules and as allowed by applicable laws. 8.3 Financial Penalty. When the division determines that a healthcare facility failed to report a sentinel event as required by these rules, the healthcare facility is subject to a financial penalty, payable to the State of Maine, of not more than $10,000 per violation. 8.3.1 Each failure to report is a separate violation.8.3.2 If a facility in good faith notified the division of a suspected sentinel event and the division later determines it is a sentinel event, the facility is not subject to a penalty for that event.8.3.3 Funds collected pursuant to these rules must be deposited in a dedicated special revenue account to be used to support sentinel event reporting and education. See 22 M.R.S.A. §8755(2).8.4 Notice of Imposition of Penalty. The SET shall send written notice to the healthcare facility stating the amount of the financial penalty imposed for failure to report a sentinel event. The notice shall include but is not limited to the date of the event and the deadline for filing an appeal of the penalty. 8.4.1 Payment of the penalty is due within 10 days of receipt of the written notice of imposition of a penalty or the date of final agency action, whichever is later.8.5 Administrative Hearing. To contest the imposition of a penalty, a healthcare facility must submit to the division a written request for an administrative hearing within 10 days of receipt of the notice of imposition of a penalty. See 22 M.R.S.A. §8755(3).8.6 Judicial Review. Judicial appeal must be in accordance with 5 M.R.S.A. chapter 375, subchapter 7.See 22 M.R.S.A. §8755(3).8.7 Injunction to require compliance. Notwithstanding any other remedies provided by law, the Office of the Attorney General may seek an injunction to require compliance with the provisions of these rules.See 22 M.R.S.A. §8755(4).8.8 District Court Complaint for violations. The Office of the Attorney General may file a complaint with the District Court seeking injunctive relief for violations of these rules.See 22 M.R.S.A. §8755(5).8.9 Incorporation by Reference. Appendix A incorporates by reference "Specifications of the Serious Reportable Events in Healthcare - 2011 Update" of the National Qualify Forum (NQF). 8.9.1 Copies of Incorporated Matter Available. In addition to its availability in Appendix A of these rules, copies of "Specifications of the Serious Reportable Events in Healthcare - 2011 Update" may be found at http://www.qualityforum.org/projects/hacs_and_sres.aspxor may be obtained at cost from the Maine DHHS, Division of Licensing and Regulatory Services, 11 State House Station, Augusta, Maine 04333.8.9.2 Non-compliance with Appendix A: Violation of Rules. Failure to comply with the provisions of Appendix A "Specifications of the Serious Reportable Events in Healthcare - 2011 Update" that is incorporated by reference constitutes a violation of these rules. See 5 M.R.S.A. §8056(1)(B)(1).10- 144 C.M.R. ch. 114, § 8