§ 1912. Definitions
As used in this chapter:
(1) "Adverse event" is any untoward incident, therapeutic misadventure, iatrogenic injury, or other undesirable occurrence directly associated with care or services provided by a health care provider or health care facility.
(2) "Causal analysis" means a formal root cause analysis, similar analytic methodologies, or any similarly effective but simplified processes that use a systematic approach to identify the basic or causal factors that underlie the occurrence or possible occurrence of a reportable adverse event, adverse event, or near miss.
(3) "Corrective action plan" means a plan to implement strategies intended to eliminate or significantly reduce the risk of a recurrence of an adverse event and to measure the effectiveness of such strategies.
(4) "Hospital" shall have the same meaning as in subdivision 1902(1) of this title.
(5) "Health care provider" shall have the same meaning as in subdivision 9402(7) of this title.
(6) "Intentional unsafe act" shall mean an adverse event or near miss that results from:
(A) a criminal act;
(B) a purposefully unsafe act;
(C) alcohol or substance abuse; or
(D) patient abuse.
(7) "Near miss" means any process variation that did not affect the outcome, but for which a recurrence carries a significant chance of a serious adverse outcome.
(8) "Reportable adverse event" means those adverse events a hospital is required to report to the department pursuant to regulations adopted under this chapter.
(9) "Safety system" means the comprehensive patient safety surveillance and improvement system established pursuant to this chapter and the regulations adopted hereunder.
(10) "Serious bodily injury" means bodily injury that creates a substantial risk of death or that causes substantial loss or impairment of the function of any bodily member or organ or substantial impairment of health or substantial disfigurement. (Added 2005, No. 215 (Adj. Sess.), § 324.)
§ 1913. Creation; implementation
(a) The commissioner shall establish a comprehensive patient safety surveillance and improvement system for the purpose of improving patient safety, eliminating adverse events in Vermont hospitals, and supporting and facilitating quality improvement efforts by hospitals. The department may contract with a qualified organization having expertise in patient safety to develop and implement all or part of the safety system.
(b) The department shall:
(1) collect data concerning the occurrence of reportable adverse events;
(2) aggregate and analyze data for the purpose of developing and implementing strategies to target and eliminate specific adverse events;
(3) verify that hospitals are in compliance with all the requirements of this chapter and regulations adopted hereunder;
(4) for reportable adverse events, verify that hospitals are conducting causal analyses and developing corrective action plans consistent with standards set by the department, current patient safety science, and relevant clinical standards;
(5) provide technical assistance or assist hospitals in locating technical assistance resources for analyzing adverse events and near misses and developing and implementing corrective action plans; and
(6) encourage hospitals to utilize anonymous in-hospital reporting when possible.
(c) The commissioner may retain or contract with such additional professional or other staff as needed to carry out responsibilities under this chapter.
(d) Beginning July 1, 2007, expenses incurred for development and implementation of the safety system shall be borne as follows: 50 percent from general fund monies and 50 percent by the hospitals.
(e) No later than January 15, 2008, the commissioner of health shall provide an interim report to the senate committee on health and welfare and the house committees on human services and on health care on the status of the safety system, its effectiveness in improving patient safety and health care quality in the state, and cost savings. No later than January 15, 2009, the commissioner shall make a final report to those committees on those subjects and shall make recommendations regarding expansion of the system to include health care facilities other than hospitals.
(f) The authority granted to the commissioner under this chapter is in addition to any other authority granted to the commissioner under law. (Added 2005, No. 215 (Adj. Sess.), § 324.)
§ 1914. Rulemaking
(a) The commissioner shall adopt rules pursuant to 3 V.S.A. chapter 25 establishing the hospital obligations listed in section 1915 of this title and otherwise necessary for the implementation of the safety system.
(b) The rules shall list reportable adverse events, which shall include the "serious reportable events" published by the National Quality Forum. The commissioner shall consult with experts and hospitals when making changes to the list of reportable adverse events and shall consider the implications of reporting requirements that may be established as a result of the federal Patient Safety and Quality Improvement Act of 2005. The department shall consult with other regulatory agencies and departments and, to the extent possible, avoid imposing duplicative reporting requirements. (Added 2005, No. 215 (Adj. Sess.), § 324.)
§ 1915. Hospital obligations
The rules adopted pursuant to this chapter shall require hospitals to:
(1) develop, maintain, and implement internal policies and procedures that meet the standards of the department to:
(A) identify, track, and analyze reportable adverse events, adverse events, and near misses;
(B) determine what type of causal analysis, if any, is appropriate;
(C) conduct causal analyses and develop corrective action plans; and
(D) disclose to patients, or, in the case of a patient death, an adult member of the immediate family, at a minimum, adverse events that cause death or serious bodily injury.
(2) report reportable adverse events to the department.
(3) provide the department with copies of its causal analysis and corrective action plan in connection with each reportable adverse event.
(4) for reportable adverse events that must also by law be reported to other departments or agencies, notify the department of health or provide a copy of any written report and provide any causal analysis information required by the department.
(5) for the purpose of evaluating a hospital's compliance with the provisions of this chapter, provide the commissioner and designees reasonable access to:
(A) information protected by the provisions of the patient's privilege under 12 V.S.A. § 1612(a) or otherwise required by law to be held confidential; and
(B) the minutes and records of a peer review committee and any other information subject to peer review protection under 26 V.S.A. § 1443. (Added 2005, No. 215 (Adj. Sess.), § 324.)
§ 1916. Intentional unsafe acts
(a) A hospital shall notify the department, within the time frames established by regulation, if the information available supports a reasonable, good faith belief that an intentional unsafe act as it pertains to patients has occurred.
(b) For intentional unsafe acts reportable to other departments or agencies, notify the department of health or provide a copy of any written report. Such reports shall not constitute a waiver of peer review or any other privilege.
(c) If the department confirms or independently concludes, based on a reasonable, good faith belief, that an intentional unsafe act occurred, it shall notify relevant state and federal licensing and other regulatory entities and, in the case of possible criminal activity, relevant state and federal law enforcement authorities.
(d) There shall be no liability on the part of and no cause of action for damages shall arise against any individual or hospital for any act or proceeding related to activities undertaken or performed within the scope of the obligations imposed by this section, provided that the individual or hospital acts without malice and with the reasonable belief that the action is warranted by the facts known after making reasonable efforts to obtain all the facts.
(e) Nothing in this section shall prevent a hospital from conducting its own investigation or peer review. (Added 2005, No. 215 (Adj. Sess.), § 324.)
§ 1917. Protection and disclosure of information
(a) All information made available to the department and its designees under this chapter shall be confidential and privileged, exempt from the public access to records law, and, in any civil or administrative action against a provider of professional health services arising out of the matters which are subject to evaluation and review by the department, immune from subpoena or other disclosure and not subject to discovery or introduction into evidence.
(b) No person with access to information made available to the commissioner or his or her designees under this chapter shall be permitted or required to testify as to any findings, recommendations, evaluations, opinions, or other actions of the department in any civil or administrative action against a provider of professional health services arising out of the matters which are subject to evaluation and review by the department.
(c) Within the department, access to peer review protected information shall be limited to individuals responsible for verifying compliance with the safety system and for providing necessary consultation and supervision to that program.
(d) Reports made to the department pursuant to subdivision 1915(4) of this chapter shall not constitute a waiver of peer review or any other privilege.
(e) Hospitals may replace health care provider identifying information in peer review materials with a surrogate identifier that allows for tracking of adverse events involving the same provider without disclosing the provider's identity.
(f) Notwithstanding subsections (a) and (b) of this section:
(1) hospitals and the department staff responsible for verifying compliance with the safety system are authorized to disclose information necessary to comply with their reporting obligations in section 1916 of this chapter;
(2) the department staff responsible for verifying compliance with the patient safety surveillance and improvement system may disclose information to others in the department, and the department may disclose information to the board of health and others responsible for carrying out the department's enforcement responsibilities with respect to this chapter if the department reasonably believes that a hospital deliberately or repeatedly has not complied with the requirements of this chapter and any regulations adopted hereunder. The commissioner, the board of health, and others responsible for carrying out the department's enforcement responsibilities with respect to this chapter are authorized to disclose such information during the course of any legal or regulatory action taken against a hospital for deliberate or repeated noncompliance with the requirements of this chapter and any rules adopted hereunder. Information disclosed under this subdivision shall otherwise maintain all applicable protections under this section and otherwise provided by law.
(g) Nothing in this section shall prohibit a hospital from making a good faith report to regulatory or law enforcement authorities based on information, documents, or records known or available to it from original sources. Information, documents, or records otherwise available from original sources are not to be construed as immune from discovery or use in any other action merely because they were made available to the department's patient safety surveillance and improvement system. (Added 2005, No. 215 (Adj. Sess.), § 324.)
§ 1918. Enforcement
(a) If the commissioner determines that a hospital has failed to comply with any of the provisions of this chapter, the commissioner may sanction the hospital as provided in this title. In evaluating compliance, the commissioner shall place primary emphasis on assuring good faith compliance and effective corrective action by the facility, reserving punitive enforcement or disciplinary action for those cases in which the facility has displayed recklessness, gross negligence, or willful misconduct or in which there is evidence, based on other similar cases known to the department, the agency of human services, or the office of the attorney general, of a pattern of significant substandard performance that has the potential for or has actually resulted in harm to patients.
(b) After notice and an opportunity for hearing, the commissioner may impose on a hospital that knowingly violates a provision of this chapter or a rule or order adopted pursuant to this chapter a civil administrative penalty of no more than $10,000.00 or, in the case of a continuing violation, a civil administrative penalty of no more than $100,000.00 or one-tenth of one percent of the gross annual revenues of the health care facility, whichever is greater. A hospital aggrieved by a decision of the commissioner under this section may appeal the commissioner's decision pursuant to section 128 of this title. (Added 2005, No. 215 (Adj. Sess.), § 324.)
§ 1919. Inclusion of data in hospital community reports
The commissioner shall consult with the commissioner of financial regulation, and with patient safety experts, hospitals, health care professionals, and members of the public and shall make recommendations to the commissioner of financial regulation concerning which data should be included in the hospital community reports required by section 9405b of this title. Beginning in 2013, the community reports shall include at a minimum data from all Vermont hospitals of reportable adverse events aggregated in a manner that protects the privacy of the patients involved and does not identify the individual hospitals in which an event occurred together with analysis and explanatory comments about the information contained in the report to facilitate the public's understanding of the data. The commissioner shall make such recommendations no more than 18 months after data collection is initiated. (Added 2005, No. 215 (Adj. Sess.), § 324; amended 2011, No. 78 (Adj. Sess.), § 2, eff. April 2, 2012; 2011, No. 171 (Adj. Sess.), § 24f, eff. Feb. 1, 2013.)