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– OREGON –
Public and Private Policy
Medical Errors and Patient Safety

Definitions

  • •  Definition of ‘serious adverse event’

    serious adverse event’ is . . "an objective and definable negative consequence of patient care, or the risk thereof, that is unanticipated, usually preventable and results in, or presents a significant risk of, patient death or serious physical injury.” [Section 1(5)].

    The statute, Section 9(1a), 2003 c.686Section 9(1a), 2003 c.686, calls for the Oregon Patient Safety Commission (OPSC) to develop

    . . "a list of objective and definable serious adverse events to be reported by participants. In developing this list, the board shall consider similar lists developed in other states and nationally. The board may change the list from time to time. The first list developed by the board shall focus on serious adverse events that caused death or serious physical injury."

  • •  Definitions are Modification of NQF Definition Template

    The ‘Reporting/Definitions Subcommittee’ developed an evaluative protocol and a proposed strategy for candidate definitions, which they addressed in July 2004 [PDF] and developed by August 4, 2004 (‘Proposed approach for defining serious adverse event’ – PDF). The Definitions Subcomittee, with subsequent approval of the Commission, modified several NQF event definitions, which evolved into the Oregon definitions(see definitions) that were published in the January 10, 2005 report to the Governor and Legislative assembly [PDF]. OREGON vs. NQF definition comparisons) are instructive, revealing that only 7 of the 30 Oregon definitions are identical to NQF definitions, despite use of the NQF definition template. Seven (7) Oregon definitions are not included in the NQF list, and all four of the NQF's ‘Criminal Events’ are not included in the Oregon definition list.

    The summary of differences between Oregon definitions and the NQF-approved 27 measures include:

    • ◊  Criminal Events Not included – NQF's ‘Criminal Events’ are not included, since they are not “Not part of [the] Commission purview” [see PDF file], and
    • ◊  JCAHO-compatible Definitions Added
    • ◊  NQF Definitions Changed – qualifying criteria for most of the remaining definitions in all but the ‘Surgery’ Category were altered, including changes from NQF events causing “death or serious physical disability to Oregon events causing “death or serious physical injury.” In addition ". . is poorly designed . ." was added to Oregon's definition of ‘Unintended use or function of device.’

Oregon Reportable Events in Health Care

(Adapted from the Oregon Patient Safety Commission
January 10, 2005 Report to the Governor [PDF]
Type of Event Additional Specifications Source(s)
1.   General Category
 
Any unanticipated, usually preventable consequence of patient care that results in patient death or serious physical injury.
Serious physical injury defined to be consistent with JCAHO guidelines. Examples of "serious physical injury" include, but are not limited to:
  • A.  Event that results in an unplanned return to the operating room or major procedural intervention.
  • B.  Event that results in transfer to the ICU with ventilatory or pressor support.
  • C.  Event that results in substantial extension of hospital stay greater than 5 days above expected.
  • D.  Event that results in an unplanned transfer to a higher level hospital.
  • E.  Healthcare acquired infections that result in patient death or serious physical injury.
  • F.  Serious adverse events that occur in hospital-sponsored outpatient settings but result in hospitalization.
Modeled on JCAHO's general sentinel event policy and JCAHO Patient Safety Goal #7.
2.   Surgical Events
A.
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. Surgery includes endoscopies and other invasive procedures.
NQF's List of Serious Reportable Events
B.
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.
Surgery includes endoscopies and other invasive procedures.
NQF
C.
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. Surgery includes endoscopies and other invasive procedures.
NQF
D.
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.
NQF
E.
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. Immediately post-operative means within 24 hours after induction of anesthesia (if surgery not completed), surgery, or other invasive procedure was completed.
NQF
3.   Product or Device Events
A.
Patient death or serious physical injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility.
Includes generally detectable contaminants in drugs, devices, or biologics regardless of the source of contamination and/or product.
Modified NQF – serious physical injury replaces serious disability
B.
Patient death or serious physical injury associated with the use or function of a device in patient care in which the device is poorly designed, or is used or functions other than as intended.
Includes, but is not limited to, catheters, drains, and other specialized tubes, infusion pumps, and ventilators.
Modified NQF – serious physical injury replaces serious disability. Also ‘poorly designed’ added to NQF definition.
C.
Patient death or serious physical injury associated with intravascular air embolism that occurs while being cared for in a healthcare facility.
Excludes deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.
Modified NQF – serious physical injury replaces serious disability
4.   Patient Protection Events
A.
Infant discharged to the wrong person
 
NQF
B.
Patient death or serious physical injury associated with patient elopement (disappearance) for more than four hours.
Excludes events involving competent adults.
Modified NQF – serious physical injury replaces serious disability
C.
Patient suicide, or attempted suicide resulting in serious physical injury, while being cared for in a healthcare facility.
Defined as events that result from patient actions after admission to a healthcare facility. Excludes deaths resulting from self-inflicted injuries that were the reason for admission to the healthcare facility.
Modified NQF – serious physical injury replaces serious disability
5.   Care Management Events
A.
Patient death or serious physical injury 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.
Modified NQF – serious physical injury replaces serious disability
B.
Patient death or serious physical injury associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products
 
Modified NQF – serious physical injury replaces serious disability
C.
Maternal death or serious physical injury associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare facility
Includes events that occur within 42 days post-delivery. Excludes deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy or cardiomyopathy.
Modified NQF – serious physical injury replaces serious disability
D.
Patient death or serious physical injury associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility
 
Modified NQF – serious physical injury replaces serious disability
E.
Death or serious physical injury (kernicterus) associated with failure to identify and treat hyperbilirubinimia in neonates
Hyperbilirubinimia is defined as bilirubin levels >30 mg/dl. Neonates refers to the first 28 days of life
Modified NQF – serious physical injury replaces serious disability
F.
Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility
Excludes progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission.
NQF
G.
Patient death or serious physical injury due to spinal manipulative therapy
 
Modified NQF – serious physical injury replaces serious disability
H.
Any perinatal death or serious physical injury unrelated to a congenital condition in an infant having a birth weight greater than 2500 grams.
Modified JCAHO
6.   Environmental Events
A.
Patient death or serious physical injury associated with an electric shock while being cared for in a healthcare facility
Excludes events involving planned treatments such as electric countershock
Modified NQF – serious physical injury replaces serious disability
B.
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.
 
NQF
C.
Patient death or serious physical injury associated with a burn incurred from any source while being cared for in a healthcare facility.
 
Modified NQF – serious physical injury replaces serious disability
D.
Patient death or serious physical injury associated with a fall while being cared for in a healthcare facility.
 
Modified NQF – serious physical injury replaces serious disability
E.
Patient death or serious physical injury associated with the use of restraints or bedrails while being cared for in a healthcare facility.
 
Modified NQF – serious physical injury replaces serious disability
  • •  Future Additions to Definitions

    The OPSC ‘Reporting/Definitions Subcommittee recommended inclusion of ‘healthcare-acquired infections’ that were to be addressed by an expert panel. Nosocomial infections (Definition #1E) were included in the definitions presented in the January 2005 report to the Governor and legislative assembly, but it is unclear how this definition of infections may be refined.

    The statute suggests that ‘near-misses’ will likely be incorporated into future versions of the reportable adverse events.

    “. . . Later lists may include, in the discretion of the board, serious adverse events that did not cause death or serious physical injury but posed a significant risk of death or a risk of significant physical injury.”

    otherwise known as ‘near-miss’ medical errors. [Section 9(1a), 2003 c.686]

  • •  Definitions approved for Pilot Project – Definitions were approved by OPSC for trial in 2005 Pilot Project for hospitals.
  • •  Separate Nursing Home Definitions

    The OPSC Definitions Subcommittee proposed a preliminary list of definitions of adverse events for nursing homes in the May 24, 2005 Minutes [PDF file]. However, the subcommittee continues to revise and discuss them with nursing home officials, including representatives of the Oregon Health Care Organization (OHCA), the organization representing nursing homes and long-term care facilities.

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