A prospective study of patient safety in the operating room.

BACKGROUND: To better understand the operating room as a system and to identify system features that influence patient safety, we performed an analysis of operating room patient care using a prospective observational technique. METHODS: A multidisciplinary team comprised of human factors experts and surgeons conducted prospective observations of 10 complex general surgery cases in an academic hospital. Minute-to-minute observations were recorded in the field, and later coded and analyzed. A qualitative analysis first identified major system features that influenced team performance and patient safety. A quantitative analysis of factors related to these systems features followed. In addition, safety-compromising events were identified and analyzed for contributing and compensatory factors. RESULTS: Problems in communication and information flow, and workload and competing tasks were found to have measurable negative impact on team performance and patient safety in all 10 cases. In particular, the counting protocol was found to significantly compromise case progression and patient safety. We identified 11 events that potentially compromised patient safety, allowing us to identify recurring factors that contributed to or mitigated the overall effect on the patient's outcome. CONCLUSIONS: This study demonstrates the role of prospective observational methods in exposing critical system features that influence patient safety and that can be the targets for patient safety initiatives. Communication breakdown and information loss, as well as increased workload and competing tasks, pose the greatest threats to patient safety in the operating room.

Making the operating room of the future safer.

There is an increasing demand for interventions to improve patient safety, but there is limited data to guide such reform. In particular, because much of the existing research is outcome-driven, we have a limited understanding of the factors and process variations that influence safety in the operating room. In this article, we start with an overview of safety terminology, suggesting a model that emphasizes "safety" rather than "error" and that can encompass the spectrum of events occurring in the operating room. Next, we provide an introduction to techniques that can be used to understand safety at the point of care and we review the data that exists relating such studies to improved outcomes. Future work in this area will need to prospectively study the processes and factors that impact patient safety and vulnerability in the operating room.

The relation of patient satisfaction with complaints against physicians and malpractice lawsuits.

PURPOSE: A small number of physicians generate a disproportionate share of complaints from patients and of malpractice lawsuits. If these grievances relate to patients' dissatisfaction with care, it might be possible to use commonly distributed patient satisfaction surveys to identify physicians at high risk of complaints from patients and of malpractice lawsuits. We sought to examine associations among patients' satisfaction survey ratings of physicians' performance and complaints from patients, risk management episodes, and rates of malpractice lawsuits. SUBJECTS AND METHODS: We examined 353 physicians at a large US teaching hospital whose inpatient performance was rated by 10 or more patients between January 1, 2001, and March 31, 2003. Physicians were divided into 3 tertiles according to satisfaction on a commercial survey instrument administered to recently discharged patients. Records of unsolicited complaints from patients (January 1, 2000, to March 31, 2003) and risk management episodes (January 1, 1983, to March 31, 2003) were analyzed after adjusting for the physician's specialty and panel characteristics of the physician's patients. RESULTS: Decreases in physicians' patient satisfaction survey scores from the highest to the lowest tertile were associated with increased rates of unsolicited complaints from patients (200 vs 243 vs 492 complaints per 100,000 patient discharges; P <0.0001) and risk management episodes (29 vs 43 vs 56 risk management episodes per 100,000 patient discharges; P = 0.007). Compared with physicians with the top satisfaction survey ratings, physicians in the middle tertile had malpractice lawsuit rates that were 26% higher (rate ratio [RR] = 1.26; 95% confidence interval [CI]: 0.72 to 2.18; P = 0.41), and physicians in the bottom tertile had malpractice lawsuit rates that were 110% higher (RR = 2.10; 95% CI: 1.13 to 3.90; P = 0.019). CONCLUSION: Patient satisfaction survey ratings of inpatient physicians' performance are associated with complaints from patients and with risk management episodes. Commonly distributed patient satisfaction surveys may be useful quality improvement tools, but identifying physicians at high risk of complaints from patients and of malpractice lawsuits remains challenging.

Using Lean principles to optimise inpatient phlebotomy services.

BACKGROUND: In the USA, inpatient phlebotomy services are under constant operational pressure to optimise workflow, improve timeliness of blood draws, and decrease error in the context of increasing patient volume and complexity of work. To date, the principles of Lean continuous process improvement have been rarely applied to inpatient phlebotomy. AIMS: To optimise supply replenishment and cart standardisation, communication and workload management, blood draw process standardisation, and rounding schedules and assignments using Lean principles in inpatient phlebotomy services. METHODS: We conducted four Lean process improvement events and implemented a number of interventions in inpatient phlebotomy over a 9-month period. We then assessed their impact using three primary metrics: (1) percentage of phlebotomists drawing their first patient by 05:30 for 05:00 rounds, (2) percentage of phlebotomists completing 08:00 rounds by 09:30, and (3) number of errors per 1000 draws. RESULTS: We saw marked increases in the percentage of phlebotomists drawing their first patient by 05:30, and the percentage of phlebotomists completing rounds by 09:30 postprocess improvement. A decrease in the number of errors per 1000 draws was also observed. CONCLUSIONS: This study illustrates how continuous process improvement through Lean can optimise workflow, improve timeliness, and decrease error in inpatient phlebotomy. We believe this manuscript adds to the field of clinical pathology as it can be used as a guide for other laboratories with similar goals of optimising workflow, improving timeliness, and decreasing error, providing examples of interventions and metrics that can be tailored to specific laboratories with particular services and resources.

A strategy for optimizing staffing to improve the timeliness of inpatient phlebotomy collections.

CONTEXT: The timely availability of inpatient test results is a key to physician satisfaction with the clinical laboratory, and in an institution with a phlebotomy service may depend on the timeliness of blood collections. In response to safety reports filed for delayed phlebotomy collections, we applied Lean principles to the inpatient phlebotomy service at our institution. Our goal was to improve service without using additional resources by optimizing our staffing model. OBJECTIVE: To evaluate the effect of a new phlebotomy staffing model on the timeliness of inpatient phlebotomy collections. DESIGN: We compared the median time of morning blood collections and average number of safety reports filed for delayed phlebotomy collections during a 6-month preimplementation period and 5-month postimplementation period. RESULTS: The median time of morning collections was 17 minutes earlier after implementation (7:42 am preimplementation; interquartile range, 6:27-8:48 am; versus 7:25 am postimplementation; interquartile range, 6:20-8:26 am). The frequency of safety reports filed for delayed collections decreased 80% from 10.6 per 30 days to 2.2 per 30 days. CONCLUSION: Reallocating staff to match the pattern of demand for phlebotomy collections throughout the day represents a strategy for improving the performance of an inpatient phlebotomy service.

Applying Lean/Toyota production system principles to improve phlebotomy patient satisfaction and workflow.

Our goals were to improve the overall patient experience and optimize the blood collection process in outpatient phlebotomy using Lean principles. Elimination of non-value-added steps and modifications to operational processes resulted in increased capacity to handle workload during peak times without adding staff. The result was a reduction of average patient wait time from 21 to 5 minutes, with the goal of drawing blood samples within 10 minutes of arrival at the phlebotomy station met for 90% of patients. In addition, patient satisfaction increased noticeably as assessed by a 5-question survey. The results have been sustained for 10 months with staff continuing to make process improvements.

Hospital volume versus outcome: an unusual example of bivariate association.

The Leapfrog Group, a consortium of more than 100 large employers, purchasing coalitions, and states that collectively provide health insurance to more than 33 million people, convened in 2000 with the goal of using market forces to improve the quality of healthcare. The resulting Leapfrog initiative suggested selective referral of complex procedures to high-volume hospitals and set volume thresholds for five procedures. This was based on the hypothesis that low-volume hospitals have higher mortality, which can be viewed in simplified statistical terms as the hypothesis that the binomial p is a decreasing function of n. The analysis of the correlation between hospitals' standardized mortality ratios (SMR, i.e., the ratio of observed to expected deaths) and hospitals' procedural volumes is revealing about the volume/mortality hypothesis. This presents an unusual pedagogic example in which the detection of correlation in the presence of nonlinear dependence is of primary interest, and thus the Pearson correlation is ideally suited. The frequently preferred nonparametric measures of bivariate association are inappropriate as they are unable to discriminate between correlation and dependence.

The volume-outcome relationship: don't believe everything you see.

This paper investigates methodological limitations of the volume-outcome relationship. A brief overview of quality measurement is followed by a discussion of two important aspects of the relationship.

The Leapfrog volume criteria may fall short in identifying high-quality surgical centers.

OBJECTIVE: The original Leapfrog Initiative recommends selective referral based on procedural volume thresholds (500 coronary artery bypass graft [CABG] surgeries, 30 abdominal aortic aneurysm [AAA] repairs, 100 carotid endarterectomies [CEA], and 7 esophagectomies annually). We tested the volume-mortality relationship for these procedures in the University HealthSystem Consortium (UHC) Clinical DatabaseSM, a database of all payor discharge abstracts from UHC academic medical center members and affiliates. We determined whether the Leapfrog thresholds represent the optimal cutoffs to discriminate between high- and low-mortality hospitals. METHODS: Logistic regression was used to test whether volume was a significant predictor of mortality. Volume was analyzed in 3 different ways: as a continuous variable, a dichotomous variable (above and below the Leapfrog threshold), and a categorical variable. We examined all possible thresholds for volume and observed the optimal thresholds at which the odds ratio is the highest, representing the greatest difference in odds of death between the 2 groups of hospitals. RESULTS: In multivariate analysis, a relationship between volume and mortality exists for AAA in all 3 models. For CABG, there is a strong relationship when volume is tested as a dichotomous or categorical variable. For CEA and esophagectomy, we were unable to identify a consistent relationship between volume and outcome. We identified empirical thresholds of 250 CABG, 15 AAA, and 22 esophagectomies, but were unable to find a meaningful threshold for CEA. CONCLUSIONS: In this group of academic medical centers and their affiliated hospitals, we demonstrated a significant relationship between volume and mortality for CABG and AAA but not for CEA and esophagectomy, based on the Leapfrog thresholds. We described a new methodology to identify optimal data-based volume thresholds that may serve as a more rational basis for selective referral.