2016 Connecticut General Statutes
Title 19a - Public Health and Well-Being
Chapter 368a - Department of Public Health
Section 19a-127n - Adverse events. Reporting requirements. Regulations. Confidentiality of reports. Retaliatory action prohibited.
(a)(1) For purposes of this section, an “adverse event” means any event that is identified on the National Quality Forum's List of Serious Reportable Events or on a list compiled by the Commissioner of Public Health and adopted as regulations pursuant to subsection (c) of this section; and “corrective action plan” means a plan that (A) implements strategies that are reflective of evidenced-based best practices and that reduce the risk of similar adverse events occurring in the future, and (B) measures the effectiveness of such strategies by addressing the implementation, oversight and time lines of such strategies.
(2) The commissioner shall review the list of adverse events periodically, but not less than annually, to ascertain whether any additions, deletions or modifications to the list are necessary.
(b) On and after October 1, 2002, a hospital or outpatient surgical facility shall report adverse events to the Department of Public Health on a form prescribed by the commissioner as follows: (1) A written report and the status of any corrective steps shall be submitted not later than seven days after the date on which the adverse event occurred; and (2) a corrective action plan shall be filed not later than thirty days after the date on which the adverse event occurred. Emergent reports, as defined in the regulations adopted pursuant to subsection (c) of this section, shall be made to the department immediately. Failure to implement a corrective action plan may result in disciplinary action by the commissioner, pursuant to section 19a-494.
(c) The commissioner shall adopt regulations, in accordance with chapter 54, to carry out the provisions of this section. Such regulations shall include, but shall not be limited to, a list of adverse events that are in addition to those contained in the National Quality Forum's List of Serious Reportable Events.
(d) On or before October first annually, the commissioner shall report, in accordance with the provisions of section 11-4a, on adverse event reporting, to the joint standing committee of the General Assembly having cognizance of matters relating to public health. For annual reports submitted on or after July 1, 2011, the commissioner shall include hospital and outpatient surgical facility adverse event information for each facility identified (1) by the National Quality Forum's List of Serious Reportable Events category, and (2) in accordance with any list compiled by the commissioner and adopted as regulations pursuant to subsection (c) of this section. Such reports shall be prepared in a format that uses relevant contextual information. For purposes of this subsection “contextual information” includes, but is not limited to, (A) the relationship between the number of adverse events and a hospital's total number of patient days or an outpatient surgical facility's total number of surgical encounters expressed as a fraction in which the numerator is the aggregate number of adverse events reported by each hospital or outpatient surgical facility by category as specified in this subsection and the denominator is the total of the hospital's patient days or the outpatient surgical facility's total number of surgical encounters, and (B) information concerning the patient population served by the hospital or outpatient surgical facility, including such hospital's or outpatient surgical facility's payor or case mix. In addition, a hospital or outpatient surgical facility may provide informational comments relating to any adverse event reported to the commissioner pursuant to this section. On and after July 1, 2011, any report submitted by the commissioner pursuant to this subsection shall include any informational comments received concerning an adverse event that is included in the report.
(e) Information collected pursuant to this section shall not be disclosed pursuant to subsection (a) of section 1-210 at any time, and information collected pursuant to this section shall not be subject to subpoena or discovery or introduced into evidence in any judicial or administrative proceeding except as otherwise specifically provided by law. Nothing in this section shall be construed to limit access to or disclosure of investigative files, including any adverse event report contained in such files, maintained by the department as otherwise provided in section 19a-499.
(f) If the department determines that it will initiate an investigation of an adverse event that has been reported, such investigation may include review by one or more practitioners with clinical expertise of the type involved in the reported adverse event.
(g) No hospital or outpatient surgical facility shall discharge, refuse to hire, refuse to serve, retaliate in any manner or take any adverse action against any employee, applicant for employment or health care provider because such employee, applicant for employment or health care provider takes or has taken any action in furtherance of the enforcement of the provisions of this section.
(P.A. 02-125, S. 3; P.A. 03-278, S. 123; P.A. 04-164, S. 1; P.A. 06-195, S. 25, 26; P.A. 10-122, S. 1.)
History: P.A. 02-125 effective July 1, 2002; P.A. 03-278 made a technical change in Subsec. (c), effective July 9, 2003; P.A. 04-164 amended Subsec. (a) by redefining “adverse event”, defining “corrective action plan” and requiring periodic review of list of adverse events, deleted former Subsec. (b) re classes of adverse events, redesignated existing Subsec. (c) as new Subsec. (b) and changed timing of required reports from 72 hours to 7 days and of corrective plans from 7 days to 30 days, but required immediate submittal of emergent reports, deleted former Subsec. (d) re corrective plans, redesignated existing Subsecs. (e) to (g) and (h) as new Subsecs. (c) to (e) and (g), respectively, changed reporting date in new Subsec. (d) from March first to October first, added provision in new Subsec. (e) re access to or disclosure of investigative files, added new Subsec. (f) re investigation of adverse event, and made technical and conforming changes throughout, effective July 1, 2004; P.A. 06-195 amended Subsec. (b) by requiring adverse event reports to be submitted on form prescribed by Commissioner of Public Health and making a technical change and amended Subsec. (c) by deleting provisions requiring prescribed form for reporting adverse events to be adopted by regulation; P.A. 10-122 amended Subsec. (a)(1) by redefining “corrective action plan” and making technical changes, amended Subsecs. (b) and (c) by making technical changes, amended Subsec. (d) by adding provisions re content and format of reports submitted by commissioner on or after July 1, 2011, and requiring that reports include hospital and outpatient surgical facility adverse event information for each facility and amended Subsec. (g) by replacing former provision re Quality of Care Advisory Committee with provision prohibiting retaliatory actions by hospital or outpatient surgical facility, effective July 1, 2010.
