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Indiana Department of Health Regulations
Creating Adverse Event Reporting

Title 410 (Department of Health)
Article 15 (Hospital Licensure Rules)
(Available at Title 410 or as PDF)

Section
 
Description
410 IAC 15-1 – Hospital Licensure
Rule 15-1.1 - Definitions for Hospital Licensure
Applicability
"ASA class 1 patient" defined
"Burn" defined
"Elopement" defined
"Hyperbilirubinemia" defined
"Hypoglycemia" defined
"immediately post-operative" defined
"intended use" defined
"Invasive procedures or treatment" defined
"Kernicterus" defined
"Low-risk pregnancy" defined
"Neonates" defined
"Serious Disability" defined
"Spinal Manipulative Therapy" defined
"Surgery" defined
"Toxic substance" defined
 
Rule 15-1.4 - Hospital Governing Board Responsibility
Reporting serious adverse events in Hospitals
Surgery Events
Products and Device Events
Patient Protection Events
Care Management Events
Environmental Events
Criminal Events
 
Rule 15-2.4 - Ambulatory Surgery Center Governing Board Responsibility
Reporting serious adverse events in Surgical Centers
Surgery Events
Products and Device Events
Patient Protection Events
Care Management Events
Environmental Events
Criminal Events
  • 410 IAC 15-1.1-1Applicability

    Authority: IC 16-21-1-7; IC 16-21-1-8; IC 16-21-1-9
    Affected: IC-16-21-1

    Sec. 1. The definitions in this rule apply throughout this article except as otherwise indicated. (Indiana State Department of Health; 410 IAC 15-1.1-1)

  • 410 IAC 15-1.1-2.1"ASA class 1 patient" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 2.1. "ASA class 1 patient" means a normal, healthy patient, without organic, physiologic, or psychiatric disturbance. (Indiana State Department of Health; 410 IAC 15-1.1-2.1)

  • 410 IAC 15-1.1-3.1"Burn" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 3.1. "Burn" means any injury to the tissues of the body caused by heat, chemicals, electricity, radiation or gases. (Indiana State Department of Health; 410 IAC 15-1.1-3.1)

  • 410 IAC 15-1.1-8.1"Elopement" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 8.1. "Elopement" 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. (Indiana State Department of Health; 410 IAC 15-1.1-8.1)

  • 410 IAC 15-1.1-13.1"Hyperbilirubinemia" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 13.1. "Hyperbilirubinemia" means bilirubin levels greater than thirty (30) mg/dl. (Indiana State Department of Health; 410 IAC 15-1.1-13.1)

  • 410 IAC 15-1.1-13.2"Hypoglycemia" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 13.2. "Hypoglycemia" means a physiologic state in which the blood sugar falls below sixty (60) mg/dl and physiological and/or neurological dysfunction begins. (Indiana State Department of Health; 410 IAC 15-1.1-13.2)

  • 410 IAC 15-1.1-13.3"immediately post-operative" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 13.3. "immediately post-operative" 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. (Indiana State Department of Health; 410 IAC 15-1.1-13.3)

  • 410 IAC 15-1.1-13.4"intended use" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 13.4. "intended use" means the use of a device as described on the label and associated materials provided by the device’s manufacturer. (Indiana State Department of Health; 410 IAC 15-1.1-13.4)

  • 410 IAC 15-1.1-13.5"Invasive procedures or treatment" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 13.5. "Invasive procedures or treatment" 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. (Indiana State Department of Health; 410 IAC 15-1.1-13.5)

  • 410 IAC 15-1.1-13.6"Kernicterus" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 13.6. "Kernicterus" means the medical condition in which elevated levels of bilirubin cause brain damage. (Indiana State Department of Health; 410 IAC 15-1.1-13.6)

  • 410 IAC 15-1.1-14.1"Low-risk pregnancy" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 14.1. "Low-risk pregnancy" 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. (Indiana State Department of Health; 410 IAC 15-1.1-14.1)

  • 410 IAC 15-1.1-15.1"Neonates" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 15.1. "Neonates" means infants in the first twenty eight (28) days of life. (Indiana State Department of Health; 410 IAC 15-1.1-15.1)

  • 410 IAC 15-1.1-20"Serious Disability" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 20. "Serious disability" means

    • (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
    • (Indiana State Department of Health; 410 IAC 15-1.1-20)
  • 410 IAC 15-1.1-21"Spinal manipulative therapy" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 21. "Spinal manipulative therapy" 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. (Indiana State Department of Health; 410 IAC 15-1.1-21)

  • 410 IAC 15-1.1-22"Surgery" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 22. "Surgery" means the diagnosis or treatment of disease, injury or deformity by operative methods, including endoscopies, colonoscopies, cardiac catheterizations and other invasive procedures. (Indiana State Department of Health; 410 IAC 15-1.1-22)

  • 410 IAC 15-1.1-23"Toxic substance" defined

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC-16-21-1

    Sec. 23. "Toxic substance" means chemicals that are present in sufficient concentration to pose a hazard to human health. (Indiana State Department of Health; 410 IAC 15-1.1-23)

  • 410 IAC 15-1.4-2.2Reporting serious adverse events – Hospitals

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: IC 16-21-1; IC 16-21-3

    Sec. 2.2(a). The hospital's quality assessment and improvement program under section 2 of this rule shall include:

    • (1)  
      • (A)  Surgical Events
        • (i)   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.
        • (ii)  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.
        • (iii)  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.
        • (iv)  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.
        • (v)  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.
      • (B)  Product or Device Events
        • (i)   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.
        • (ii)  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.
        • (iii)  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.
      • (C)  Patient Protection Events
        • (i)   Infant discharged to the wrong person.
        • (ii)  Patient death or serious disability associated with patient elopement (disappearance) for more than four hours. Excludes events involving competent adults.
        • (iii)  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.
      • (D)  Care Management Events
        • (i)   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.
        • (ii)  Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products.
        • (iii)  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.
        • (iv)  Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in the hospital.
        • (v)  Death or serious disability (kernicturus) associated with failure to identify and treat hyperbilirubinemia in neonates.
        • (vi)  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.
        • (vii)  Patient death or serious disability due to spinal manipulation therapy performed in the hospital.
      • (E)  Environmental Events
        • (i)   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.
        • (ii)  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.
        • (iii)  Patient death or serious disability associated with a burn incurred from any source while being cared for in the hospital.
        • (iv)  Patient death associated with a fall while being cared for in the hospital.
        • (v)  Patient death or serious disability associated with the use of restraints or bedrails while being cared for in the hospital.
      • (F)  Criminal Events
        • (i)   Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider.
        • (ii)  Abduction of a patient of any age.
        • (iii)  Sexual assault on a patient within or on the grounds of the hospital.
        • (iv)  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; and
    • (2)  A process for reporting to the department each serious adverse event listed in subsection (a)(1) of this rule that is determined by the hospital's quality assessment and improvement program to have occurred within the hospital.
  • Sec. 2.2(b). Subject to subsection (e) of this rule, the process for determining the occurrence of the serious adverse events listed in subsection (a)(1) of this rule by the hospital's quality assessment and improvement program shall be designed by the hospital to accurately determine the occurrence of any of the serious adverse events listed in subsection (a)(1) of this rule within the hospital in a timely manner.

  • Sec. 2.2(c). Subject to subsection (e) of this rule, the process for reporting the occurrence of a serious adverse event listed in subsection (a)(1) of this rule shall comply with the following:

    • (1)  The report shall be made to the department.
    • (2)  The report shall be submitted not later than fifteen (15) working days after the serious adverse event is determined to have occurred by the hospital's quality assessment and improvement program.
    • (3)  The report shall identify the serious adverse event and the hospital, but shall not include any identifying information for any patient, individual licensed under IC 25, or hospital employee involved, or any other information.
    • (4)  The report shall be accompanied by a signed written statement from the hospital's chief executive officer, or the officer's designee, that acknowledges the submission of the report by the hospital.
    • (5)  The report, and any documents permitted under this section to accompany the report, shall be submitted in an electronic format, including a format for electronically affixed signatures.
  • Sec. 2.2(d). The hospital's report of a serious adverse event listed in subsection (a)(1) shall be used by the department for purposes of publicly reporting the type and number of such serious adverse events occurring within each hospital. The department's public report will be issued no less frequently than annually.

  • Sec. 2.2(e). [The following subsection (e) will not appear in the emergency rule.] Any serious adverse event listed in subsection (a)(1), that is determined to have occurred within the hospital between January 1, 2006 and the effective date of this rule and has not been previously reported must be reported within five (5) days of the effective date of this rule. (Indiana State Department of Health; 410 IAC 15-1.4-2.2)

  • 410 IAC 15-2.4-2.2Reporting serious adverse events – Ambulatory Surgical Centers

    Authority: IC 16-19-3-4; IC 16-21-1-7
    Affected: 16-21-1; IC 16-21-2-2

    Sec. 2.2(a). The center's quality assessment and improvement program under section 2 of this rule shall include:

    • (1)  A process for determining the occurrence of the following serious adverse events within the center:
      • (A)  Surgical Events
        • (i)   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.
        • (ii)  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.
        • (iii)  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.
        • (iv)  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.
        • (v)  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.
      • (B)  Product or Device Events
        • (i)   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.
        • (ii)  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.
        • (iii)  Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in the center. Excludes deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.
      • (C)  Patient Protection Events
        • (i)  Patient death or serious disability associated with patient elopement (disappearance) for more than four hours. Excludes events involving competent adults.
        • (ii)  Patient suicide or attempted suicide resulting in serious disability, while begin cared for in the center, defined as events that result from patient actions after admission to the center. Excludes deaths resulting from self-inflicted injuries that were the reason for admission to the center.
      • (D)  Care Management Events
        • (i)   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.
        • (ii)  Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products.
        • (iii)  Patient death or serious disability due to spinal manipulation therapy performed in the center.
      • (E)  Environmental Events
        • (i)   Patient death or serious disability associated with an electric shock while being cared for in the center. Excludes events involving planned treatment, such as electrical countershock.
        • (ii)  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.
        • (iii)  Patient death or serious disability associated with a burn incurred from any source while being cared for in the center.
        • (iv)  Patient death associated with a fall while being cared for in the center.
        • (v)  Patient death or serious disability associated with the use of restraints or bedrails while being cared for in the center.
      • (F)  Criminal Events
        • (i)   Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider.
        • (ii)  Abduction of a patient of any age.
        • (iii)  Sexual assault on a patient within or on the grounds of the center.
        • (iv)  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 center; and
    • (2)  A process for reporting to the department each serious adverse event listed in subsection (a)(1) of this rule that is determined by the center's quality assessment and improvement program to have occurred within the center.
  • Sec. 2.2(b). Subject to subsection (e) of this rule, the process for determining the occurrence of the serious adverse events listed in subsection (a)(1) of this rule by the center's quality assessment and improvement program shall be designed by the center to accurately determine the occurrence of any of the serious adverse events listed in subsection (a)(1) of this rule within the center in a timely manner.

  • Sec. 2.2(c). Subject to subsection (e) of this rule, the process for reporting the occurrence of a serious adverse event listed in subsection (a)(1) of this rule shall comply with the following:

    • (1)  The report shall be made to the department.
    • (2)  The report shall be submitted as soon as reasonably and practicably possible, but not later than fifteen (15) working days after the serious adverse event is determined to have occurred by the center's quality assessment and improvement program.
    • (3)  The report shall identify the serious adverse event and the center, but shall not include any identifying information for any patient, individual licensed under IC 25, or center employee involved, or any other information.
    • (4)  The report shall be accompanied by a signed written statement from the center's chief executive officer, or the officer's designee, that acknowledges the submission of the report by the center.
    • (5)  The report, and any documents permitted under this section to accompany the report, shall be submitted in an electronic format, including a format for electronically affixed signatures.
  • Sec. 2.2(d). The center's report of a serious adverse event listed in subsection (a)(1) shall be used by the department for purposes of publicly reporting the type and number of such serious adverse events occurring within each center. The department's public report will be issued no less frequently than annually.

  • Sec. 2.2(e). [The following subsection (e) will not appear in the emergency rule.] Any serious adverse event listed in subsection (a)(1) of this rule that is determined to have occurred within the center between January 1, 2006 and the effective date of this rule and has not been previously reported must be reported within five (5) days of the effective date of this rule. (Indiana State Department of Health; 410 IAC 15-2.4-2.2)

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