OBJECTIVE: Patient Safety Indicator (PSI) 15, or "Accidental Puncture or Laceration" (APL), of the US Agency for Healthcare Research and Quality was recently endorsed as a consensus standard for quality of care by the National Quality Forum. We sought to determine the positive predictive value (PPV) of this indicator. METHODS:: We conducted a retrospective cross-sectional study of hospitalization records that met PSI 15 criteria. We sampled cases from 32 geographically diverse hospitals, including both teaching and nonteaching hospitals, between October 1, 2005 and March 31, 2007. Trained abstractors from each center reviewed randomly sampled medical records, using a standard instrument. We determined the PPV of the indicator and conducted descriptive analyses of the cases. RESULTS:: Of the 249 cases that met PSI 15 criteria, 226 (91%; 95% CI: 88%-94%) represented true APL. Fifty-six of the true APL cases (24%) represented injuries that generally would be expected to heal without repair, yielding, from the standpoint of clinical relevance, a PPV of 68% (95% CI: 62%-74%). True positive cases that would typically warrant repair (n=170) were most likely to involve the gastrointestinal tract (30%), bladder (25%), dura (19%), or an important blood vessel (16%). In 97 of the true APL cases (43%), adhesions or other scar tissue were thought to have contributed to the complication. The 23 false-positive cases involved no apparent event other than normal operative conduct (n=7), a complication other than APL (bleeding, infection, dislodgement of a gastrostomy tube, or fracture) (7), an APL present on admission (5), or a disease-related lesion (4). CONCLUSIONS:: Although PSI 15 is highly predictive of APL from a coding perspective, the indicator is less predictive of APL that could be considered clinically important. A significant proportion of cases represent relatively inconsequential injuries or injuries for which the risk may have been acceptable relative to the goals of the procedure.
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