2005 Connecticut Code - Sec. 19a-127n. Adverse events. Reporting requirements. Regulations. Confidentiality of reports.

      Sec. 19a-127n. Adverse events. Reporting requirements. Regulations. Confidentiality of reports. (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 (d) of this section; and "corrective action plan" means a plan that implements strategies that reduce the risk of similar adverse events occurring in the future, and 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 as follows: (1) A written report and the status of any corrective steps shall be submitted not later than seven days after the adverse event occurred; and (2) a corrective action plan shall be filed not later than thirty days after 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 of Public Health, pursuant to section 19a-494.

      (c) The Commissioner of Public Health 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 and a prescribed form for the reporting of adverse events pursuant to subsection (b) of this section. The commissioner may require the use of said form prior to the adoption of said regulations.

      (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.

      (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) The Quality of Care Advisory Committee established pursuant to section 19a-127l shall establish methods for informing the public regarding access to the department's consumer and regulatory services.

      (P.A. 02-125, S. 3; P.A. 03-278, S. 123; P.A. 04-164, 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 seventy-two hours to seven days and of corrective plans from seven days to thirty 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.