HB1476ham002 97TH GENERAL ASSEMBLY

Rep. Mary E. Flowers

Filed: 4/6/2011

09700HB1476ham002 LRB097 06656 CEL 53877 a

AMENDMENT TO HOUSE BILL 1476

AMENDMENT NO. ______. Amend House Bill 1476, AS AMENDED, as follows:

on page 1, immediately below line 3, by inserting the following:

"Section 3. The Hospital Licensing Act is amended by adding Section 9.7 as follows:

(210 ILCS 85/9.7 new)

Sec. 9.7. Health care facility requirements to report adverse events resulting in patient death or serious disability.

(a) Definitions. As used in this Act:

(1) "Death" means a patient's death related to an adverse event and not related solely to the natural course of the patient's illness or underlying condition. Events otherwise reportable shall be reported even if the death might have otherwise occurred as the natural course of the patient's illness or underlying condition.

(2) "Serious disability" means a physical or mental impairment, including loss of a body part, related to an adverse event and not related solely to the natural course of the patient's illness or underlying condition, 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 prior to discharge or is still present at the time of discharge from an inpatient health care facility.

(b) Notwithstanding any other reporting requirements of State law or regulation, each health care facility shall report to the Department, in the form and manner required by the Department, the occurrence of any of the adverse health care events described in subsections (c) through (h) of this Section no later than 30 days after discovery of the event. The Department shall determine from the information provided in the report if there is a basis for further investigation to determine if there were any violations of the standards and procedures covered by this Act.

(c) Surgical events reportable under this subsection are:

(1) surgery performed on a wrong body part that is not consistent with the documented informed consent for that patient; reportable events under this clause do not include situations requiring prompt action that occur in the course of surgery or situations whose 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 clause do not include situations requiring prompt action that occur in the course of surgery or situations whose 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; and

(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.

(d) Product or device events reportable under this subsection are:

(1) patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the health care 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; and

(3) patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a health care facility, excluding deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.

(e) Patient protection events reportable under this subsection are:

(1) an infant discharged to the wrong person;

(2) patient death or serious disability associated with patient disappearance for more than 4 hours, excluding events involving adults who have decision-making capacity; and

(3) patient suicide or attempted suicide resulting in serious disability while being cared for in a health care facility due to patient actions after admission to the health care facility, excluding deaths resulting from self-inflicted injuries that were the reason for admission to the health care facility.

(f) Care management events reportable under this subsection are:

(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 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 health care facility, excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy; and

(4) patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility for a condition unrelated to hypoglycemia.

(g) Environmental events reportable under this subsection are:

(1) patient death or serious disability associated with an electric shock while being cared for in a health care 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 health care facility that is not consistent with the documented informed consent for that patient; reportable events under this clause do not include situations requiring prompt action that occur in the course of surgery or situations whose urgency precludes obtaining informed consent;

(4) patient death associated with a fall while being cared for in a health care facility; and

(5) patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility.

(h) Physical security events reportable under this subsection are:

(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 health care facility; and

(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 health care facility.".