Module Components

• Overview
• Learning Activities

Topics

• QI methodologies
• Health Care Quality and Data Sources

NURS 834 - Translating Evidence to Practice

Module 14 and 15: Understanding and Evaluating Data - Global, National, Local

QI methodologies

Six Sigma

Six Sigma, originally designed as a business strategy, involves improving, designing, and monitoring process to minimize or eliminate waste while optimizing satisfaction and increasing financial stability. The performance of a process—or the process capability—is used to measure improvement by comparing the baseline process capability (before improvement) with the process capability after piloting potential solutions for quality improvement. There are two primary methods used with Six Sigma. One method inspects process outcome and counts the defects, calculates a defect rate per million, and uses a statistical table to convert defect rate per million to a s (sigma) metric. This method is applicable to pre-analytic and post-analytic processes (a.k.a. pretest and post-test studies). The second method uses estimates of process variation to predict process performance by calculating a metric from the defined tolerance limits and the variation observed for the process. This method is suitable for analytic processes in which the precision and accuracy can be determined by experimental procedures.

One component of Six Sigma uses a five-phased process that is structured, disciplined, and rigorous, known as the define, measure, analyze, improve, and control (DMAIC) approach. To begin, the project is identified, historical data are reviewed, and the scope of expectations is defined. Next, continuous total quality performance standards are selected, performance objectives are defined, and sources of variability are defined. As the new project is implemented, data are collected to assess how well changes improved the process.

To support this analysis, validated measures are developed to determine the capability of the new process. Six Sigma and PDSA are interrelated. The DMAIC methodology builds on Shewhart’s plan, do, check, and act cycle. The key elements of Six Sigma are related to PDSA as follows: the plan phase of PDSA is related to define core processes, key customers, and customer requirements of Six Sigma; the do phase of PDSA is related to measure performance of Six Sigma; the study phase of PDSA is related to analyze of Six Sigma; and the act phase of PDSA is related to improve and integrate of Six Sigma.

Root Cause Analysis

Root cause analysis (RCA), used extensively in engineering and similar to critical incident technique, is a formalized investigation and problem-solving approach focused on identifying and understanding the underlying causes of an event as well as potential events that were intercepted. The Joint Commission requires RCA to be performed in response to all sentinel events and expects, based on the results of the RCA, the organization to develop and implement an action plan consisting of improvements designed to reduce future risk of events and to monitor the effectiveness of those improvements.

RCA is a technique used to identify trends and assess risk that can be used whenever human error is suspected with the understanding that system, rather than individual factors, are likely the root cause of most problems. A similar procedure is critical incident technique, where after an event occurs, information is collected on the causes and actions that led to the event.

An RCA is a reactive assessment that begins after an event, retrospectively outlining the sequence of events leading to that identified event, charting causal factors, and identifying root causes to completely examine the event. Because it is a labor-intensive process, ideally a multidisciplinary team trained in RCA triangulates or corroborates major findings and increases the validity of findings. Taken one step further, the notion of aggregate RCA (used by the Veterans Affairs (VA) Health System) is purported to use staff time efficiently and involves several simultaneous RCAs that focus on assessing trends, rather than an in-depth case assessment.

Using a qualitative process, the aim of RCA is to uncover the underlying cause(s) of an error by looking at enabling factors (e.g., lack of education), including latent conditions (e.g., not checking the patient’s ID band) and situational factors (e.g., two patients in the hospital with the same last name) that contributed to or enabled the adverse event (e.g., an adverse drug event). Those involved in the investigation ask a series of key questions, including what happened, why it happened, what were the most proximate factors causing it to happen, why those factors occurred, and what systems and processes underlie those proximate factors. Answers to these questions help identify ineffective safety barriers and causes of problems so similar problems can be prevented in the future. Often, it is important to also consider events that occurred immediately prior to the event in question because other remote factors may have contributed. The final step of a traditional RCA is developing recommendations for system and process improvement(s), based on the findings of the investigation. The importance of this step is supported by a review of the literature on root-cause analysis, where the authors conclude that there is little evidence that RCA can improve patient safety by itself. A nontraditional strategy, used by the VA, is aggregate RCA processes, where several simultaneous RCAs are used to examine multiple cases in a single review for certain categories of events.

Due the breadth of types of adverse events and the large number of root causes of errors, consideration should be given to how to differentiate system from process factors, without focusing on individual blame. The notion has been put forth that it is a truly rare event for errors to be associated with irresponsibility, personal neglect, or intention, a notion supported by the IOM. Yet efforts to categorize individual errors—such as the Taxonomy of Error Root Cause Analysis of Practice Responsibility (TERCAP), which focuses on “lack of attentiveness, lack of agency/fiduciary concern, inappropriate judgment, lack of intervention on the patient’s behalf, lack of prevention, missed or mistaken healthcare provider’s orders, and documentation error” may distract the team from investigating systems and process factors that can be modified through subsequent interventions. Even the majority of individual factors can be addressed through education, training, and installing forcing functions that make errors difficult to commit.

Lean

The core idea of LEAN is to maximize customer value while minimizing waste. Simply, lean means creating more value for customers with fewer resources. A lean organization understands customer value and focuses its key processes to continuously increase it. The ultimate goal is to provide perfect value to the customer through a perfect value creation process that has zero waste. To accomplish this, lean thinking changes the focus of management from optimizing separate technologies, assets, and vertical departments to optimizing the flow of products and services through entire value streams that flow horizontally across technologies, assets, and departments to customers.

Eliminating waste along entire value streams, instead of at isolated points, creates processes that need less human effort, less space, less capital, and less time to make products and services at far less costs and with much fewer defects, compared with traditional business systems. Companies are able to respond to changing customer desires with high variety, high quality, low cost, and with very fast throughput times. Also, information management becomes much simpler and more accurate.