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Indiana's 27 Reportable Hospital
Serious Adverse Events

(Modified from NQF 27 Serious reportable Events in Health Care and Indiana State Department of Health Regulations [Word .doc])
No. DefLink Description of Event
Surgical Events
1 1A Surgery performed on the Wrong Body Part
Surgery performed on the wrong body part, defined as any surgery performed on a body part that is not consistent with the documented informed consent for that patient. Excludes emergent situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent.
2 1B Surgery performed on the wrong patient
Surgery performed on the wrong patient, defined as any surgery on a patient that is not consistent with the documented informed consent for that patient.
3 1C Wrong surgical procedure performed on a patient
Wrong surgical procedure performed on a patient, defined as any procedure performed on a patient that is not consistent with the documented informed consent for that patient. Excludes emergent situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent.
4 1D Retained Foreign Body
Retention of a foreign object in a patient after surgery or other procedure. Excludes objects intentionally implanted as part of a planned intervention and objects present prior to surgery that were intentionally retained.
5 1E Death of health patient
Intraoperative or immediately post-operative death in an ASA Class I patient. Includes all ASA Class I patient deaths in situations where anesthesia was administered; the planned surgical procedure may or may not have been carried out.
Product or Device Events
6 2A Contaminated drugs, devices, or biologics
Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the hospital. Includes generally detectable contaminants in drugs, devices or biologics regardless of the source of contamination or product.
7 2B Unintended use or function of device
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. Includes, but is not limited to, catheters, drains, and other specialized tubes, infusion pumps, and ventilators.
8 2C Intravascular Air Embolism
Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in the hospital. Excludes deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.
Patient Protection Events
9 3A Infant discharged to the wrong person
10 3B Patient Missing over 4 hours
Patient death or serious disability associated with patient elopement (disappearance) for more than four hours. Excludes events involving competent adults.
11 3C Patient suicide or attempted suicide
Patient suicide or attempted suicide resulting in serious disability, while begin cared for in the hospital, defined as events that result from patient actions after admission to the hospital. Excludes deaths resulting from self-inflicted injuries that were the reason for admission to the hospital.
Care Management Events
12 4A Medication Error
Patient death or serious disability associated with a medication error (e.g. errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration). Excludes reasonable differences in clinical judgment on drug selection and dose.
13 4B ABO-incompatible Blood or blood products
Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products.
14 4C Maternal Labor or delivery
Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in the hospital. Includes events that occur within forty-two (42) days post-delivery. Excludes deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy or cardiomyopathy.
15 4D Hypoglycemia
Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in the hospital.
16 4E Neonatal Hyperbilirubinemia
Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates.
17 4F Hospital-acquired Decubitus Ulcers
Stage 3 or 4 pressure ulcers acquired after admission to the hospital. Excludes progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission.
18 4G Spinal Manipulative Therapy
Patient death or serious disability due to spinal manipulation therapy performed in the hospital.
Environmental Events
19 5A Electric Shock
Patient death or serious disability associated with an electric shock while being cared for in the hospital. Excludes events involving planned treatment, such as electrical countershock.
20 5B Patient oxygen or gas line improperly designated
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.
21 5C Burn while receiving care
Patient death or serious disability associated with a burn incurred from any source while being cared for in the hospital.
22 5D Fall of patient associated with death
Patient death associated with a fall while being cared for in the hospital.
23 5E Use or lack of restraints or bedrails
Patient death or serious disability associated with the use of restraints or bedrails while being cared for in the hospital.
Criminal Events
24 6A Instance of Care provided by impersonator
Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider.
25 6B Abduction of a patient of any age
26 6C Sexual Assault of Patient
Sexual assault on a patient within or on the grounds of the hospital.
27 6D Physical Assault of Patient or Staff
Death or significant injury of a patient or staff member resulting from a physical assault (i.e. battery) that occurs within or on the grounds of the hospital
 
TERM DEFINITIONS
ASA class 1 patient
as defined by 410 IAC 15-1.1-2.1, means a normal, healthy patient, without organic, physiologic, or psychiatric disturbance.
burn
as defined by 410 IAC 15-1.1-3.1, means any injury to the tissues of the body caused by heat, chemicals, electricity, radiation or gases.
elopement
as defined by 410 IAC 15-1.1-8.1, means any situation in which a registered or admitted patient, excluding competent adults, leaves the hospital without staff being aware that the patient has done so.
hyperbilirubionemia
as defined by 410 IAC 15-1.1-13.1, means bilirubin levels greater than thirty (30) mg/dl.
hypoglycemia
as defined by 410 IAC 15-1.1-13.2, means a physiologic state in which the blood sugar falls below sixty (60) mg/dl and physiological and/or neurological dysfunction begins.
immediately post-operative
as defined by 410 IAC 15-1.1-13.3, means within twenty-four (24) hours after induction of anesthesia (if surgery not completed), or within twenty-four (24) hours after completion of surgery or other invasive procedure.
intended use
as defined by 410 IAC 15-1.1-13.4, means the use of a device as described on the label and associated materials provided by the device's manufacturer.
invasive procedures or treatment
as defined by 410 IAC 15-1.1-13.5, means a puncture or incision of the skin or insertion of an instrument or foreign material into the body, but excludes venipuncture for phlebotomy and diagnostic tests without contrast agents.
kernicterus
as defined by 410 IAC 15-1.1-13.6, means the medical condition in which elevated levels of bilirubin cause brain damage.
low-risk pregnancy
as defined by 410 IAC 15-1.1-14.1, means a woman aged 18-39, with no previous diagnosis of essential hypertension, renal disease, collagen-vascular disease, liver disease, cardiovascular disease, placenta previa, multiple gestation, intrauterine growth retardation, smoking, pregnancy-induced hypertension, premature rupture of membranes, or other previously documented condition that poses a high risk of poor pregnancy outcome.
neonates
as defined by 410 IAC 15-1.1-15.1, means infants in the first twenty eight (28) days of life.
serious disability
as defined by 410 IAC 15-1.1-20, is
  • (1) a physical or mental impairment that substantially limits one (1) or more major life activities of an individual;
  • (2) a loss of bodily function if the impairment or loss lasts more than seven (7) days or is still present at the time of discharge from a hospital or center; or
  • (3) loss of a body part
spinal manipulative therapy
as defined by 410 IAC 15-1.1-21, means all types of manual techniques, including spinal mobilization (movement of a joint within its physiologic range of motion) and manipulation (movement beyond its physiologic range of motion), regardless of their precise anatomic and physiologic focus or their discipline of origin.
surgery
as defined by 410 IAC 15-1.1-22, means the diagnosis or treatment of disease, injury or deformity by operative methods, including endoscopies, colonoscopies, cardiac catheterizations and other invasive procedures.
toxic substances
as defined by 410 IAC 15-1.1-23, means chemicals that are present in sufficient concentration to pose a hazard to human health.
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