Analyzing and reporting quality processes are an integral component of today’s world, regardless of the area of application, be it medical, manufacturing, customer service, or other areas. In order to allow an exploration of quality in nuclear cardiology, this chapter will provide definitions of quality today and examine five common cycles that have been used to promote quality improvement, each with their own unique characteristics that make them particularly well suited for specific applications. Utilization of quality-driven processes and their impact on cost and value will also be addressed. In this context, the importance of quality and its integration into global accreditation and certification processes, including the similarities and differences among the various bodies providing accreditation will be discussed. Clinical application of quality improvement methodologies regarding patient and test selection, performance, interpretation, reporting, and the development of a quality improvement program for each of these areas will be the next area of focus. Finally, the chapter will provide information regarding reporting of quality performance initiatives and the use of registries and benchmarks in clinical nuclear cardiology today.
Quality in nuclear cardiology today has much broader implications than just producing high-quality images. With the advent of appropriate use criteria, the availability of multiple imaging modalities and protocols, multiple settings in which nuclear cardiology imaging can be delivered, interpretation of nuclear cardiology tests by multiple specialties, pay-for-performance initiatives including accreditation and certification and the regulatory requirements for reporting, “quality” has become a much larger topic in everything we do in nuclear cardiology.1 This chapter will address the many facets of quality today.
The current definition of quality can vary greatly depending upon the perspective of an individual or organization. It is clearly a perception that is supported by data depending upon the metrics utilized. Quality can range from the daily quality control testing performed to insure optimal camera performance to the ability of a nuclear cardiology study to reduce downstream healthcare expense. Given this broad range of quality in current practice it is important to understand some basic definitions. The traditional quality assurance activities that have been used in nuclear cardiology have focused on insuring high-quality imaging. These have been focused around quality control and quality assurance whose definitions imply maintaining performance of a process, for example, image acquisition, over a period of time and within specified parameters. The performance of this type of testing is addressed in Chapter 6 of this book. A well-functioning nuclear cardiology laboratory today has an established protocol for maintenance and assurance of quality control. More recently, quality improvement has become a focus of processes within the nuclear cardiology laboratory, in large part to maintain accreditation. Quality improvement initiatives were initially focused on process-driven measures of performance, such as report turnaround times or availability of the next appointment. More recently quality improvement has expanded to more outcome-driven measures such as radiation reduction, correlation with downstream testing results, and patient/physician satisfaction surveys.
It is no longer adequate to just insure the quality of the images. Quality improvement in nuclear cardiology must include all aspects of the complex nuclear cardiology imaging process from order entry and test selection to reporting and impact on future testing and patient outcomes including functional status, quality of life, and reductions in morbidity and mortality. In order for any quality improvement program to be successful, the program must be iterative continuously striving to improve on prior performance through a cyclical assessment. Cyclical models of quality improvement will be addressed next.
Five quality improvement cycles that have had their greatest success and healthcare applications include the FOCUS-PDCA model, LEAN, Six-Sigma, FMEA, and the Milestones models. Selection of one of these tools as a mechanism to assist with improving quality will depend on the type of project, the team members involved, and the need for one time versus continued quality improvement. As a laboratory looks to improve processes, selection of the best cycle will facilitate the greatest potential for change in the least amount of time with greatest cost efficiency. The cycles have their unique features which will be independently examined and are summarized in Table 6-1.
| Quality Cycle | Project Scope | Project Size | Special Features |
|---|---|---|---|
| FOCUS-PDCA | Maximize performance of pre-existing processes | Small to large | Developed by Hospital Corporation of America; variation of PDCA |
| LEAN | Reduction of inefficiencies and waste adversely affecting performance | Usually large and multi-step serial processes | Numerous tools developed to facilitate. Need trained staff to facilitate improvement process |
| Six-Sigma | Reduce variation in currently functioning processes | Usually large and complex projects involving numerous teams | Reduces variability in process resulting in reduced waste and inventory and improved throughput |
| FMEA | Predict future product failures due to prior failures; usually applied to new designs and processes | Usually utilized in multi-step cross departmental processes | Analysis based on severity, likelihood of occurrence and ability to detect future failure |
| Milestones | Assessment of process most likely to succeed | Small to large | Serial process requiring completion of a step before proceeding to next step |
FOCUS-PDCA is designed to maximize the performance of pre-existing processes. This includes: Finding a process that is in need of improvement, Organizing a team of knowledgeable stakeholder’s regarding the process crossing various levels of the organization, Clarifying current processes and the changes needed to achieve improvement, Understanding the potential for variability by measuring performance and whether or not the process is currently under control or not and Selecting actions that are necessary to improve the process. After this initial assessment has been performed a traditional plan-do-check-act quality improvement project can be undertaken. The planning phase of this model includes projections of what leadership believes will happen as a result of the improvement project. The “doing” phase is comprised of four major components including educating and training staff, developing a plan that allows implementation on a small scale before broader implementation, documenting any problems or unexpected observations and adjust as necessary, and developing the tools that will be utilized to analyze the data. The third phase, check, assesses the effectiveness of the intervention with regard to the goals outlined in the earlier planning phase. The final phase, act, is the broad scale implementation of the change within the organization. It is intended that this cycle back to the first step in the process to understand if further process improvement is necessary.2,3
The LEAN model is specifically focused on reducing insufficiency in a repetitive process such as unnecessary human movement, waiting for supplies, doing more than necessary to meet requirements, poor-quality work resulting in rework, inventory not matching need, unnecessary movement of resources, delivery of services that are unwanted by the customer, and finally overproduction. To focus on these areas of inefficiency the lean process includes six steps including problem definition from the customer’s perspective, examination of current work procedures and processes, team-based identification of improvement opportunities, identifying root causes of the problem, define a new process to address root causes, and design of an implementation plan including measures to determine success and the timeline to achieve them.2
Six-Sigma is a tool that is widely used in healthcare today and is primarily focused on reducing performance variability. The most successful Six-Sigma projects would result in a defect rate of less than 4 per 1 million opportunities. The Six-Sigma process emphasizes variation control, results oriented activities, and the use of data to drive the process. It can be highly impactful and can also have significant limitations in healthcare applications due to patient care variability that cannot be accounted for in a process control model.2,4
The Failure Mode Effect Analysis is a tool that has been used to predict future failure based on past failures and has been traditionally used for evaluation of newly designed clinical processes. The tool focuses on those steps that have the greatest risk for failure and identifying and mitigating them prior to their occurrence. This has unique significance in the healthcare industry given the high rate of change we are currently experiencing and the significant potential impact of change with negative patient outcomes.4
Given the many opportunities for improvement in quality in healthcare, the Milestones model has particular applicable ability because it focuses on evaluating processes and Majors which have the greatest opportunity for improvement. The seven steps are as follows: Involving measurement and performance in the daily activities of the organization, identifying the typical categories of concepts to be measured, identifying specific measures for improvement, development of operational definitions of specific measures, developing a robust plan for data collection plan and data gathering, data analysis and, finally, actual data collection necessary for the organization to develop plans for implementation. This is an extremely data-driven model which depending upon the organization and its culture and infrastructure has a greater potential for success.5
The importance of cycles in quality improvement should be evident from the five models examined. As we implement change to improve processes and outcomes in the nuclear cardiology laboratory, it is important to continuously monitor the impact of those changes on the real outcome. Many times changes in one area result in unintended consequences in other portions of the process that may have greater adverse impact on the outcome than the original improvement was designed to address. As a new process stabilizes and the outcome is consistent, given the critical nature of patient care, it is important to move from an improvement to a monitoring program to insure that changes elsewhere in the complex nuclear cardiology imaging cycle have not affected a process with an established outcome.
Nuclear cardiology has been on the leading edge of the cost and value discussion as it regards overall quality of cardiovascular care. As a result, there have been numerous studies evaluating the clinical value relative to the cost of care delivery of a nuclear cardiology study as noted in a recent information statement from the American Society of Nuclear Cardiology.6 Quality plays an important role in this discussion because a poor-quality study has no value and only cost. It is therefore essential that we strive to perform only the highest-quality studies. A useful quality indicator in all laboratories could be that a poor-quality study is of such importance that a root cause analysis be performed to understand how to prevent this in the future. This should result in the lowest number possible poor-quality studies being performed.
Having controlled the number of poor-quality studies, emphasis can then be placed on the cost of performing the test. Opportunities to understand the cost of each component of a study and evaluate mechanisms for reducing the cost are essential. Analysis of cost reduction opportunities can result in the need to improve infrastructure in such a way that new lower cost methodologies can be implemented, such as cameras with more highly sensitive detectors allowing faster imaging time and reduced use of radiopharmaceuticals. A major area of cost savings is the utilization of appropriate use criteria, an inappropriately performed study is the most expensive from a population health-based perspective, increasing the total cost of care with the potential to increase cost and risk to the patient by adding further downstream testing that is likely to have minimal clinical impact.
The value of a test is dependent upon its ability to impact clinical outcomes, future testing, and future therapy. A test may have a high cost but be of greater value due to its ability to influence morbidity, mortality, and cost of future therapy in a positive manner, such as positron emission tomography. In order for a test to have high value, it must have significant clinical impact to change or affirm a therapeutic course, at a reasonable cost. The value of testing will be dependent on a number of factors including the quality and cost of the test itself, the quality and cost of downstream diagnostic testing resulting from the nuclear cardiology test, the cost of a therapeutic intervention and its impact on morbidity and mortality. Many of these will be local factors dependent upon the expertise and infrastructure available at the clinical site. The END multicenter study group demonstrated this through the observation that stable chest pain patients who underwent a more aggressive diagnostic strategy of cardiac catheterization first had higher initial costs, increased interventional procedures and great follow-up cost over a composite 3-year follow-up period.7
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