CHAPTER 287
HB 592-FN – FINAL VERSION
24Mar2009… 0687h
05/13/09 1498s
10Jun2009… 2081eba
2009 SESSION
01/09
HOUSE BILL 592-FN
AN ACT relative to “adverse events” in hospitals and ambulatory surgical centers.
SPONSORS: Rep. Batula, Hills 19; Rep. Hess, Merr 9; Rep. Irwin, Hills 3; Rep. Rosenwald, Hills 22; Rep. Tilton, Merr 6; Sen. Sgambati, Dist 4; Sen. Letourneau, Dist 19; Sen. Roberge, Dist 9
COMMITTEE: Health, Human Services and Elderly Affairs
This bill establishes a reporting system for hospitals and ambulatory surgical centers to report adverse events.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
24Mar2009… 0687h
05/13/09 1498s
10Jun2009… 2081eba
09-0221
01/09
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Nine
AN ACT relative to “adverse events” in hospitals and ambulatory surgical centers.
Be it Enacted by the Senate and House of Representatives in General Court convened:
287:1 Statement of Purpose. The general court finds that 95,000 people die as a result of “adverse events” in hospitals and ambulatory surgical centers nationally every year. The general court further finds that 4 in 10 physicians state that they have personally experienced adverse events. The general court recognizes that New Hampshire is the only New England state which does not have laws addressing adverse events. Therefore, the general court hereby establishes a reporting system to facilitate quality improvement in the health care system.
287:2 New Subdivision; Adverse Events Reporting System. Amend RSA 151 by inserting after section 35 the following new subdivision:
Adverse Events Reporting System
151:36 Definitions. In this subdivision:
I. “Commissioner” means the commissioner of the department of health and human services.
II. “Department” means the department of health and human services.
III. “Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual or a loss of bodily function, if the impairment or loss lasts more than 7 days or is still present at the time of discharge from an inpatient health care facility, or loss of a body part.
IV. “ Surgery” means the treatment of disease, injury, or deformity by manual or operative methods. Surgery includes endoscopies and other invasive procedures.
151:37 Hospitals and Ambulatory Surgical Centers Required to Report Adverse Events.
I. Any hospital or ambulatory surgical center licensed pursuant to this chapter shall report to the commissioner the occurrence of any of the adverse health care events described in subparagraphs (a)-(f) as soon as is reasonably and practically possible, but no later than 15 working days after discovery of the event. The report shall be filed in a format specified by the commissioner and shall identify the facility but shall not include any identifying information for any of the health care professionals, facility employees, or patients involved. The commissioner may consult with experts and organizations familiar with patient safety when developing the format for reporting and in further defining events in order to be consistent with industry standards. Events to be reported under this subdivision include:
(a) Surgical events including:
(1) Surgery performed on a wrong body part that is not consistent with the documented informed consent for that patient. Reportable events under this subparagraph do not include situations requiring prompt action that occur in the course of surgery or situations where urgency precludes obtaining informed consent.
(2) Surgery performed on the wrong patient.
(3) The wrong surgical procedure performed on a patient that is not consistent with the documented informed consent for that patient. Reportable events under this subparagraph do not include situations requiring prompt action that occur in the course of surgery or situations where urgency precludes obtaining informed consent.
(4) Retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained.
(5) Death during or immediately after surgery of a normal, healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance and for whom the pathologic processes for which the operation is to be performed are localized and do not entail a systemic disturbance.
(b) Product or device events including:
(1) Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the facility when the contamination is the result of generally detectable contaminants in drugs, devices, or biologics regardless of the source of the contamination or the product.
(2) Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended. “Device” includes, but is not limited to, catheters, drains, and other specialized tubes, infusion pumps, and ventilators.
(3) Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a facility, excluding deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.
(c) Patient protection events including:
(1) An infant discharged to the wrong person.
(2) Patient death or serious disability associated with patient disappearance, excluding events involving adults who have decision-making capacity.
(3) Patient suicide or attempted suicide resulting in serious disability while being cared for in a facility due to patient actions after admission to the facility, excluding deaths resulting from self-inflicted injuries that were the reason for admission to the facility.
(d) Care management events including:
(1) Patient death or serious disability associated with a medication error, including, but not limited to, errors involving the wrong drug, the wrong dose, the wrong patient, the wrong time, the wrong rate, the wrong preparation, or the wrong route of administration, excluding reasonable differences in clinical judgment on drug selection and dose.
(2) Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products.
(3) Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a facility, including events that occur within 42 days postdelivery and excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy.
(4) Patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for in a facility.
(5) Death or serious disability, including kernicterus, associated with failure to identify and treat hyperbilirubinemia in neonates during the first 28 days of life. “Hyperbilirubinemia” means bilirubin levels greater than 30 milligrams per deciliter.
(6) Stage 3 or 4 ulcers acquired after admission to a facility, excluding progression from stage 2 to stage 3 if stage 2 was recognized upon admission.
(7) Patient death or serious disability due to spinal manipulative therapy.
(8) Artificial insemination with the wrong donor sperm or wrong egg.
(e) Environmental events including:
(1) Patient death or serious disability associated with an electric shock while being cared for in a facility, excluding events involving planned treatments such as electric countershock.
(2) Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances.
(3) Patient death or serious disability associated with a burn incurred from any source while being cared for in a facility.
(4) Patient death or serious disability associated with a fall while being cared for in a facility.
(5) Patient death or serious disability associated with the use or lack of restraints or bedrails while being cared for in a facility.
(f) Criminal events including:
(1) Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider.
(2) Abduction of a patient of any age.
(3) Sexual assault on a patient within or on the grounds of a facility.
(4) Death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a facility.
II. Following the occurrence of an adverse health care event, the facility shall conduct a root cause analysis of the event. Following the analysis, the facility shall implement a corrective action plan to implement the findings of the analysis or report to the commissioner any reasons for not taking corrective action. If the root cause analysis and the implementation of a corrective action plan are complete at the time an event must be reported, the findings of the analysis and the corrective action plan shall be included in the report of the event. The findings of the root cause analysis and a copy of the corrective action plan shall otherwise be filed with the commissioner within 60 days of the event.
III. All information and data made available to the department and its designees under this section shall be confidential and shall be exempt from public access under RSA 91-A.
151:38 Commissioner’s Duties and Responsibilities.
I. The commissioner shall establish an adverse health event reporting system designed to facilitate quality improvement in the health care system. The reporting system shall not be designed to punish errors by health care practitioners or health care facility employees.
II. The reporting system shall consist of:
(a) Mandatory reporting by facilities of adverse health care events.
(b) Mandatory completion of a root cause analysis and a corrective action plan by the facility and reporting of the findings of the analysis and the plan to the commissioner or reporting of reasons for not taking corrective action.
(c) Analysis of reported information by the commissioner to determine patterns of systemic failure in the health care system and successful methods to correct these failures.
(d) Sanctions against facilities for failure to comply with reporting system requirements.
(e) Communication from the commissioner to health care facilities, health care purchasers, and the public to maximize the use of the reporting system to improve health care quality.
III. The commissioner is not authorized to select from or between competing alternate acceptable medical practices.
IV. The commissioner shall:
(a) Analyze adverse event reports, corrective action plans, and findings of the root cause analyses to determine patterns of systemic failure in the health care system and successful methods to correct these failures.
(b) Communicate to individual facilities the commissioner’s conclusions, if any, regarding an adverse event reported by the facility.
(c) Communicate with relevant health care facilities any recommendations for corrective action resulting from the commissioner’s analysis of submissions from facilities.
(d) Publish an annual report describing, by facility, adverse events reported, outlining, in aggregate, corrective action plans and the findings of root cause analyses and making recommendations for legislation relative to state health care operations.
V. The commissioner shall report the list of reportable events under this section to the National Quality Forum and, working in coordination with the National Quality Forum, to the other states. The commissioner shall monitor discussions by the National Quality Forum of amendments to the forum’s list of reportable events and shall report to the general court whenever the list needs to be modified. The commissioner shall also monitor implementation efforts in other states to establish a list of reportable events and shall make recommendations to the general court as necessary for modifications in the New Hampshire list or in the other components of the New Hampshire reporting system to keep the system as nearly uniform as possible with similar systems in other states.
VI. Nothing in this section shall be construed to limit the responsibilities and duties of the department under RSA 151.
151:39 Penalties; Fund Established.
I. Any facility which violates this subdivision for failure to file a timely adverse event report or failure to conduct a root cause analysis, to implement a corrective action plan, or to provide the findings of a root cause analysis or corrective action plan in a timely fashion shall be subject to disciplinary action under this chapter and any other appropriate sanctions under this chapter.
II. There is hereby established the “adverse events” fund to be used to carry out the provisions of this subdivision. The fund shall be composed of fines collected under this chapter, gifts, grants, donations, bequests, or other moneys from any public or private source and shall be used to support adverse event data collection, analysis, reporting, and education. The fund shall be nonlapsing and shall be continually appropriated to the commissioner of the department of health and human services for the purposes of this subdivision.
287:3 New Subparagraph; Special Fund; “Adverse Events” Fund. Amend RSA 6:12, I(b) by inserting after subparagraph (276) the following new subparagraph:
(277) Moneys deposited in the “adverse events” fund established under RSA 151:39, II.
287:4 Contingency. If HB 433-FN-A of the 2009 legislative session becomes law, RSA 151:36-39 as inserted by section 2 of this act shall be renumbered as RSA 151:37-40, respectively, and the reference to RSA 151:39, II in RSA 6:12, I(b)(277) as inserted by section 3 of this act shall be renumbered as RSA 151:40, II.
287:5 Effective Date. This act shall take effect January 1, 2010.
Approved: July 29, 2009
Effective Date: January 1, 2010