Morris John A, Carrillo Ysela, Jenkins Judith M, Smith Philip W, Bledsoe Sandy, Pichert James, White Andrew
Section of Surgical Sciences, Division of Trauma and Surgical Critical Care, Vanderbilt University Medical Center, 243 Medical Center South, 2100 Pierce Avenue, Nashville, TN 37212-3755, USA.
Ann Surg. 2003 Jun;237(6):844-51; discussion 851-2. doi: 10.1097/01.SLA.0000072267.19263.26.
To review all admissions (age > 13) to three surgical patient care centers at a single academic medical center between January 1, 1995, and December 6, 1999, for significant surgical adverse events.
Little data exist on the interrelationships between surgical adverse events, risk management, malpractice claims, and resulting indemnity payments to plaintiffs. The authors hypothesized that examination of this process would identify performance improvement opportunities overlooked by standard medical peer review; the risk of litigation would be constant across the three homogeneous patient care centers; and the risk management process would exceed the performance improvement process.
Data collected included patient demographics (age, gender, and employment status), hospital financials (hospital charges, costs, and financial class), and outcome. Outcome categories were medical (disability: <1 month, 1-6 months, permanent/death), legal (no legal action, settlement, summary judgment), financial (indemnity payments, legal fees, write-offs), and cause and effect analysis. Cause and effect analysis attempts to identify system failures contributing to adverse outcomes. This was determined by two independent analysts using the 17 Harvard criteria and subdividing these into subsystem causative factors.
The study group consisted of 130 patients with surgical adverse events resulting in total liabilities of $8.2 million US dollars. The incidence of adverse events per 1,000 admissions across the three patient care centers was similar, but indemnity payments per 1,000 admissions varied (cardiothoracic = $30 US dollars, women's health = $90 US dollars, trauma = $520 US dollars). Patient demographics were not predictive of high-risk subgroups for adverse events or litigation. In terms of medical outcome, 51 patients had permanent disability or death, accounting for 98% of the indemnity payments. In terms of legal outcome, 103 patients received no indemnity payments, 15 patients received indemnity payments, four suits remain open, and in eight cases charges were written off ($0.121 million US dollars). To date, no cases have been adjudicated in court. Cause and effect analysis identified 390 system failures contributing to the adverse events (mean 3.0 failures per adverse event); there were 4.7 failures per adverse event in the 15 indemnity cases. Five categories of causes accounted for 75% of the failures (patient management, n = 104; communication, n = 89; administration, n = 33; documentation, n = 32; behavior, n = 23). The current medical review process would have identified 104 of 390 systems failures (37%).
This study demonstrates no rational link between the tort system and the reduction of adverse events. Sixty-three percent of contributing causes to adverse events were undetected by current medical review processes. Adverse events occur at the interface between different systems or disciplines and result from multiple failures. Indemnity costs per hospital day vary dramatically by patient care center (range $3.60-97.60 US dollars a day). The regionalization of healthcare is in jeopardy from the burden of high indemnity payments.
回顾1995年1月1日至1999年12月6日期间,一家学术医疗中心的三个外科患者护理中心收治的所有13岁以上患者发生的重大手术不良事件。
关于手术不良事件、风险管理、医疗事故索赔以及向原告支付的赔偿之间的相互关系,现有数据很少。作者推测,对这一过程的审查将发现标准医学同行评审所忽视的绩效改进机会;三个同类患者护理中心的诉讼风险将是恒定的;风险管理过程将超过绩效改进过程。
收集的数据包括患者人口统计学信息(年龄、性别和就业状况)、医院财务数据(医院收费、成本和财务类别)以及结果。结果类别包括医疗(残疾:<1个月、1 - 6个月、永久性/死亡)、法律(无法律诉讼、和解、简易判决)、财务(赔偿支付、法律费用、核销)以及因果分析。因果分析试图确定导致不良后果的系统故障。这由两名独立分析师根据17项哈佛标准确定,并将其细分为子系统致病因素。
研究组由130例发生手术不良事件的患者组成,总负债达820万美元。三个患者护理中心每1000例入院患者的不良事件发生率相似,但每1000例入院患者的赔偿支付额有所不同(心胸外科 = 30美元,女性健康科 = 90美元,创伤科 = 520美元)。患者人口统计学信息无法预测不良事件或诉讼的高危亚组。在医疗结果方面,51例患者有永久性残疾或死亡,占赔偿支付额的98%。在法律结果方面,103例患者未获得赔偿支付,15例患者获得了赔偿支付,4起诉讼仍未结案,8起案件的费用被核销(12.1万美元)。迄今为止,尚无案件在法庭上判决。因果分析确定了390个导致不良事件的系统故障(平均每个不良事件3.0个故障);15起赔偿案件中每个不良事件有4.7个故障。五类原因占故障的75%(患者管理,n = 104;沟通,n = 89;管理,n = 33;文件记录,n = 32;行为,n = 23)。当前的医学审查过程能够识别390个系统故障中的104个(37%)。
本研究表明侵权制度与不良事件减少之间没有合理联系。当前医学审查过程未发现63%的不良事件促成原因。不良事件发生在不同系统或学科的交界处,是由多种故障导致的。每个患者护理中心每天的赔偿成本差异很大(范围为每天3.60 - 97.60美元)。高额赔偿支付的负担使医疗保健的区域化面临风险。