Code of Vermont Rules › Agency 13 - AGENCY OF HUMAN SERVICES › Sub-Agency 140 - DEPARTMENT OF HEALTH › Chapter 068 - PATIENT SAFETY SURVEILLANCE AND IMPROVEMENT SYSTEM › Section 13 140 068 - PATIENT SAFETY SURVEILLANCE AND IMPROVEMENT SYSTEM

Current through June, 2024
Part I General
				Provisions
Section 1.1 Purpose
This rule implements the Patient Safety Surveillance and
				  Improvement System created by 18 V.S.A. Chapter 43A.
Section 1.2 Authority
This rule is adopted under the authority of
				  3 VSA §§
												801(b)(11) and
				  3003(a)
				  and
				  18
				  VSA §§
											102 and
				  1914.
Section 1.3 Scope
This rule shall apply to all facilities licensed by the
				  Vermont Board of Health pursuant to 18 V.S.A. Chapter 43.
Section 1.4 Effective Date
All provisions of this rule shall be effective on January 1,
				  2008.
Section 1.5
				Definitions
1. "Adverse event" means 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. "Commissioner" means the commissioner of
				the Vermont Department of Health.
4. "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.
5. "Department" means
				the Vermont Department of Health.
6. "Hospital" shall have the same meaning as
				in
				18 V.S.A. §
												1902(1).
7. "Hospital staff means a health care
				provider, employee or volunteer providing services at the hospital.
8. "Health care provider" shall have the same
				meaning as in
				18 V.S.A. §
												9402(8).
9. "Intentional unsafe act" means 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.
10. "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.
11. "NQF" refers to the National Quality
				Forum.
12. "Patient Safety
				Surveillance and Improvement System" refers to the Patient Safety Surveillance
				and Improvement System of the Vermont Department of Health.
13. "Reportable adverse event" means those
				adverse events a hospital is required to report to the Department as provided
				in this rule.
14. "Safety system"
				means the comprehensive patient safety surveillance and improvement system
				established pursuant to 18 V.S.A. Chapter 43A and this rule.
15. "Secure reporting system" means the
				Patient Safety Surveillance and Improvement System of the Department of Health
				secure electronic adverse event reporting system.
16. "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.
Section 1.6 Protection and Disclosure of
				Information
1. All information made available
				to the Department and its designees pursuant to 18 V.S.A. Chapter 43A and this
				rule shall be confidential and privileged and 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. All
				information submitted to the Patient Safety Surveillance and Improvement System
				shall be disclosed only as permitted or required by law.
2. The Patient Safety Surveillance and
				Improvement System shall maintain secure filing and storage of all electronic
				and non-electronic confidential and privileged records.
3. Within the Department, access to peer
				review protected information shall be limited to individuals designated by the
				Commissioner who are responsible for verifying compliance with the Safety
				System and for providing necessary consultation and supervision to that
				program. Reports made to the Department pursuant to
				18 V.S.A. §
												1915(4) shall not constitute
				a waiver of peer review or any other privilege.
Section 1.7 Reporting Methods
1. The Department may establish a secure
				reporting system for submission of reports required by this rule.
2. Each hospital shall submit reports
				required by this rule to the Patient Safety Surveillance and Improvement System
				using a secure transmission method, such as to and from a secure fax number,
				certified mail or other documented delivery system or, if established by the
				Department, through the secure reporting system.
3. If a secure reporting system is
				established, a hospital may apply annually to the Department for a software
				license. Each hospital shall ensure that only authorized hospital staff has
				access to the secure reporting system and that the software is used exclusively
				for meeting the requirements of 18 V.S.A. Chapter 43A and this rule.
Section 1.8 Hospital Contribution
				Formula
1. Annually, each hospital shall pay
				to the Department an amount determined using the total expense amounts from
				each hospital's budget approved by the Vermont Department of Banking,
				Insurance, Securities and Health Care Administration for the current fiscal
				year and calculated as follows: The individual hospital total expense divided
				by the total system expense for all hospitals and the resulting percentage
				multiplied by the amount of the general fund appropriation for the Patient
				Safety Surveillance and Improvement System for the fiscal year beginning July
				1.
2. The total contributions from
				all hospitals shall equal 50% of the Patient Safety Surveillance and
				Improvement System budget and shall equal the general fund appropriation for
				that fiscal year.
3. No later than
				December 1, 2007, the Department will notify each hospital of the amount due
				for fiscal year 2008, which shall be paid to the Department no later than
				December 31, 2007. For each subsequent year, the Department will notify each
				hospital of the amount due no later than June 1 and payment shall be made by
				the hospital to the Department no later than July 1 of that year. In the event
				that the legislature does not take final action on the general fund
				appropriation for the Patient Safety Surveillance and Improvement System by
				June 15, the Department will notify each hospital of the amount due within
				fifteen (15) days following final action on the appropriation and the hospital
				shall make payment within thirty (30) days of notification.
Section 1.9 Hospital Record
				Retention
Each hospital shall retain all documents and data in any
				  format relating to the investigation of any adverse event, near miss or
				  intentional unsafe act for a period of at least seven (7) years and discarding
				  or destruction of such documents and data in any format during that period is
				  prohibited.
Section 1.10
				Enforcement
The Department may use all enforcement powers granted to it
				  under Title 18 to ensure compliance with the requirements of 18 V.S.A. Chapter
				  43A and this rule.