Risk Factors for Retained Instruments and Sponges after Surgery

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Abstract

Risk factors for medical errors remain poorly understood. We performed a case-control study of retained foreign bodies in surgical patients in order to identify risk factors for this type of error. We reviewed the medical records associated with all claims or incident reports of a retained surgical sponge or instrument filed between 1985 and 2001 with a large malpractice insurer representing one third of the physicians in Massachusetts. For each case, we identified an average of four randomly selected controls who underwent the same type of operation during the same six-month period. Our study included 54 patients with a total of 61 retained foreign bodies (of which 69 percent were sponges and 31 percent instruments) and 235 control patients. Thirty-seven of the patients with retained foreign bodies (69 percent) required reoperation, and one died. Patients with retained foreign bodies were more likely than controls to have had emergency surgery (33 percent vs. 7 percent, P<0.001) or an unexpected change in surgical procedure (34 percent vs. 9 percent, P<0.001). Patients with retained foreign bodies also had a higher mean body-mass index and were less likely to have had counts of sponges and instruments performed. In multivariate analysis, factors associated with a significantly increased risk of retention of a foreign body were emergency surgery (risk ratio, 8.8 [95 percent confidence interval, 2.4 to 31.9]), unplanned change in the operation (risk ratio, 4.1 [95 percent confidence interval, 1.4 to 12.4]), and body-mass index (risk ratio for each one-unit increment, 1.1 [95 percent confidence interval, 1.0 to 1.2]). The risk of retention of a foreign body after surgery significantly increases in emergencies, with unplanned changes in procedure, and with higher body-mass index. Case--control analysis of medical-malpractice claims may identify and quantify risk factors for specific types of errors. Copyright 2003 Massachusetts Medical Society

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Most cited references 7

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Relation between malpractice claims and adverse events due to negligence. Results of the Harvard Medical Practice Study III.

Ian Newhouse, P Weiler, A Lawthers … (1991)

By matching the medical records of a random sample of 31,429 patients hospitalized in New York State in 1984 with statewide data on medical-malpractice claims, we identified patients who had filed claims against physicians and hospitals. These results were then compared with our findings, based on a review of the same medical records, regarding the incidence of injuries to patients caused by medical management (adverse events). We identified 47 malpractice claims among 30,195 patients' records located on our initial visits to the hospitals, and 4 claims among 580 additional records located during follow-up visits. The overall rate of claims per discharge (weighted) was 0.13 percent (95 percent confidence interval, 0.076 to 0.18 percent). Of the 280 patients who had adverse events caused by medical negligence as defined by the study protocol, 8 filed malpractice claims (weighted rate, 1.53 percent; 95 percent confidence interval, 0 to 3.2 percent). By contrast, our estimate of the statewide ratio of adverse events caused by negligence (27,179) to malpractice claims (3570) is 7.6 to 1. This relative frequency overstates the chances that a negligent adverse event will produce a claim, however, because most of the events for which claims were made in the sample did not meet our definition of adverse events due to negligence. Medical-malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.

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The retained surgical sponge.

C W Kaiser, S Friedman, K P Spurling … (1996)

A review was performed to investigate the frequency of occurrence and outcome of patients who have retained surgical sponges. Closed case records from the files of the Medical Professional Mutual Insurance Company (ProMutual, Boston, MA) involving a claim of retained surgical sponges were reviewed for a 7-year period. Retained sponges occurred in 40 patients, comprising 48% of all closed claims for retained foreign bodies. A falsely correct sponge count after an abdominal procedure was documented in 76% of these claims. Ten percent of claims involved vaginal deliveries and minor non-body cavity procedures, for which no sponge count was performed. Total indemnity payments were $2,072,319, and defense costs were $572,079. In three cases, the surgeon was deemed responsible by the court despite the nursing staff's admitting liability and evidence presented that the surgeon complied completely with the standard of care. A wide range of indemnity payments was made despite a remarkable similarity of outcome in the patients studied. Despite the rarity of the reporting of a retained surgical sponge, this occurrence appears to be encountered more commonly than generally is appreciated. Operating teams should ensure that sponges be counted for all vaginal and any incisional procedures at risk for retaining a sponge. In addition, the surgeon should not unquestioningly accept correct count reports, but should develop the habit of performing a brief but thorough routine postprocedure wound/body cavity exploration before wound closure. The strikingly similar outcome for most patients would argue for a standardized indemnity payment being made without the need for adversarial legal procedures.

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Negligent care and malpractice claiming behavior in Utah and Colorado.

D M Studdert, E J Thomas, H R Burstin … (2000)

Previous studies relating the incidence of negligent medical care to malpractice lawsuits in the United States may not be generalizable. These studies are based on data from 2 of the most populous states (California and New York), collected more than a decade ago, during volatile periods in the history of malpractice litigation. The study objectives were (1) to calculate how frequently negligent and nonnegligent management of patients in Utah and Colorado in 1992 led to malpractice claims and (2) to understand the characteristics of victims of negligent care who do not or cannot obtain compensation for their injuries from the medical malpractice system. We linked medical malpractice claims data from Utah and Colorado with clinical data from a review of 14,700 medical records. We then analyzed characteristics of claimants and nonclaimants using evidence from their medical records about whether they had experienced a negligent adverse event. The study measures were negligent adverse events and medical malpractice claims. Eighteen patients from our study sample filed claims: 14 were made in the absence of discernible negligence and 10 were made in the absence of any adverse event. Of the patients who suffered negligent injury in our study sample, 97% did not sue. Compared with patients who did sue for negligence occurring in 1992, these nonclaimants were more likely to be Medicare recipients (odds ratio [OR], 3.5; 95% CI [CI], 1.3 to 9.6), Medicaid recipients (OR, 3.6; 95% CI, 1.4 to 9.0), > or =75 years of age (OR, 7.0; 95% CI, 1.7 to 29.6), and low income earners (OR, 1.9; 95% CI, 0.9 to 4.2) and to have suffered minor disability as a result of their injury (OR, 6.3; 95% CI, 2.7 to 14.9). The poor correlation between medical negligence and malpractice claims that was present in New York in 1984 is also present in Utah and Colorado in 1992. Paradoxically, the incidence of negligent adverse events exceeds the incidence of malpractice claims but when a physician is sued, there is a high probability that it will be for rendering nonnegligent care. The elderly and the poor are particularly likely to be among those who suffer negligence and do not sue, perhaps because their socioeconomic status inhibits opportunities to secure legal representation.