- • 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)].
. . "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
January 10, 2005 Report to the Governor [PDF]
- • 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.