Emergency medical services providers, like other health care workers, are dedicated to improving the lives of their patients. Unfortunately, even with the best of intentions, there are times where the care provided may be suboptimal. This may be the result of an error by an individual provider or a larger system issue. Providers and organizations should embrace quality improvement efforts as a means of reducing errors and improving clinical care to benefit the overall health of the patients they serve.

• 
  

  Describe the components of an EMS agency CQI program.

  
  
• 
  

  Describe the components of an EMS system CQI program (local, regional, state).

  
  
• 
  

  Discuss how the CQI process interfaces with protocol design (Chapter 5) and provider education (Chapter 7).

  
  
• 
  

  Discuss surveillance of high-risk call types and procedures.

  
  
• 
  

  Define retrospective and prospective CQI, and give examples of their use.

  
  
• 
  

  Determine how patient care can be evaluated through analysis of tasks and outcomes.

  
  
• 
  

  Describe how the Plan-Do-Check-Act model can be used to evaluate system changes.

  
  
• 
  

  Understand the legal protections that may, or may not, be afforded to the CQI process.

  
  
• 
  

  Discuss what it means to develop a culture of quality and safety.

  
  
• 
  

  Discuss the importance of utilizing a Just Culture approach.

Oversight and active involvement in continuous quality improvement (CQI) is a key component of any medical director’s duties to an EMS agency. CQI has been defined as a “structured organizational process for involving personnel in planning and executing a continuous flow of improvements to provide quality health care that meets or exceeds expectations.”¹ When considering CQI in the EMS system it is logical to consider the components of a quality improvement program (Box 6-1).¹ In examining a provider, agency, or system, quality measures (now better known as performance indicators [PI]) must be examined and applied to programs and initiative designed to improve quality and patient safety.

The basics of modern day quality improvement can be traced back to manufacturing principles from the Industrial Age. As mass production spread, it was necessary to ensure products looked similar, worked the same, and had minimal flaws or defects. Initially, these principles were limited to manufacturing and other “product”-based industries. Manufacturing is often seen as a linear process where an idea is developed and ultimately sold. The actual making of the product is typically straightforward, with high repetition and limited variability. In manufacturing, quality is often considered “conformance to requirements.”² Historically, health care was not thought of as a product, but instead a process to maintain and improve an individual’s state of health. In health care, the focus is typically on health outcomes and not defects in a product.

The process is individualized to the patient and situation. As a result, provider input and variability is never completely standardized.² Over time, however, efforts have been made to bring TQM principles to light in health care and are the basis for the development of CQI. When examined more generally, some of the characteristics of manufacturing TQM can again be seen in the evaluation of the delivery of modern health care. In EMS, the call taking and dispatch processes are similar to an assembly line (Figure 6-1). When quality is redefined as customer satisfaction and improved outcomes, the so-called “product” of patient care and transport is more easily assessed. While the focus on improving efficiencies can apply in the EMS setting, the main focus is on reducing errors and improving patient outcomes.

KEY POINTS IN THE DEVELOPMENT OF MEDICAL QUALITY

Two very important publications lead to a significant cultural impact on physicians and the health care system that helped drive the system toward evidence-based medical practice and quality assessment. The Flexner Report (published by Abraham Flexner in 1910) exposed the serious failings of the American medical education system and detailed some of the major deficits in the practice patterns of American physicians. The resulting pressure from the American public strengthened the mission of the newly founded Council on Medical Education and a large number of medical schools were closed and the number of schools was less than half in just 25 years after the report. Around the same time Dr Ernest Amory Codman was pushing for hospital reform and advancing his idea of the “end-result system.” He was possibly the first doctor to champion an organized system for evaluation of the outcome of medical practice on patients and advocated not only for the use of this information to guide medical practice, but also believed the information should be made public so that patients could choose their doctors and hospitals based on their outcome performance. Sir William Osler is credited with many accomplishments that advanced medical education and patient care, including moving medical student education the bedside, creation of residency training, and emphasizing the importance of the patient interview. Dr Olser has also been credited with introducing morbidity and mortality discussions to standard medical education for students and practicing physicians. In 1952, the Joint Commission on Accreditation of Hospitals (JCAH) was formed and began its work based on evaluation of hospital-based medical care and the policies and procedures that guided patient safety, leading to an “accreditation” that now has significant financial implications based on eligibility for reimbursement for care provided. Standardization and benchmarking of modern hospital patient safety efforts have been credited to this organization and their accreditation process. Most EMS medical directors know this organization as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO); however, they have changed the name again, and it is now known as The Joint Commission (TJC). Dr Avedis Donabedian‘s work in the 1950s to 1960s to develop an organized study and approach to health care quality is also a key component of the development of the modern CQI process. His 1966 paper entitled “Evaluating the Quality of Medical Care” is still considered an important work for study.

MODERN QUALITY MANAGEMENT STRATEGIES

In many ways the worlds of corporate business and medical practice are now intertwined, and as the recognition of medical care as an industry has matured they have increasingly been recognized as sharing many quality management goals. The pioneers of the modern quality management movement included W. Edwards Deming, Walter Shewhart, Joseph Juran, Philip Crosby.^2,4 Deming and Shewart developed the Plan-Do-Check-Act (PDCA) model (described later); Juran was among the first to directly link the quality improvement processes of manufacturing to the health care setting.⁴ Juran also broke the process down into three steps: quality planning or ensuring the process will meet standards; quality control or checking to make sure the product is correct; and quality improvement, focusing on making the process and product better.³, These strategies were building blocks of the modern concept of total quality management (TQM) described in 2001 by Cua, McKone, and Schroeder that went beyond these principles and pulled in concepts relevant to customers and supply as well; however, this is not always easily translated into a program focused on patient outcomes.⁵ There are also several other well-known names associated with the principles of quality improvement, including ISO 9001:2000, Six Sigma, and Baldridge. Both Six Sigma and Baldridge have been studied and applied extensively to hospital settings, with degrees of success in improved efficiencies and processes.^6,7 The Lean methodology, commonly combined with Six Sigma, relates to streamlining processes and is not necessarily germane to the focus of patient safety and CQI in EMS, however, may be employed by administrators managing the operational components of an agency or system. These concepts can be compared by their component areas of focus (Box 6-2). Box 6-2 Comparison of Quality Improvement Concepts

It is important for the EMS physician and medical director to recognize that key personnel and leadership at multiple levels of the EMS system must be actively engaged in CQI. Each level of organization has slightly different ideal roles in the overall system and participants at these levels must be careful to maintain their focus on important task relative to the particular level of CQI being performed. Although the highest level or system administration could attempt to perform, or be directly involved at all levels, this would prove impractical and very inefficient.

AGENCY CQI

At the agency level the CQI committee and other key personnel should consider focusing on surveillance and improvement of specific provider PI and the overall performance of the agency. Individual providers should be compared to their peers using statistics (usually evaluating for a deviation from the mean) that can allow CQI committee members and the medical director to identify individual providers that may need additional education of remediation in the identified areas. In addition, agency level CQI should include review of the agency means for PI and consider comparison to other agencies in the system or to national benchmarks. Derivation from these means could signify a need for agency-wide education and/or process improvement. CQI done at this level allows for understanding of procedural detail that may be causing some poor performance and members may be able to derive specific initiatives or process/procedure changes in an effort to improve outcomes.

SYSTEM (COUNTY/REGIONAL) CQI

At the system level, the focus should shift to evaluation of patient outcomes and the review of policies, procedures, and protocols that affect overall delivery of patient care. In some cases, a county or regional level agency may have a regulatory duty/authority over individual provider CQI when certain types of errors are made or other criteria are met. This may also be a function of state-level CQI and may result in the suspension of privileges or revocation of licensure. CQI at this level should also focus on the sharing of PI findings among agencies in the system. Errors should be reviewed in an effort to alert other agencies to the possibility of similar problems, and for the purpose of sharing quality improvement initiatives. This level of CQI should also be used to demonstrate examples of exceptional care, and to share this information with other agencies for their benefit by modeling examples of successful practice.

STATE CQI

Some functions of the state-level CQI may be somewhat similar to the system-level program; however, the state usually has regulatory authority concerns that guide the particular goals of CQI. Protocol review, narcotic diversion issues, scope-of-practice determinations, licensure concerns, and grant funding programs aimed at supporting quality improvement and best practices may all be the focus of CQI at this level.

NATIONAL CQI

Establishing national standards and setting benchmarks for PI are among the CQI goals at the national level. In some cases, nation-wide CQI efforts may guide the legislative process, set criteria for receipt of grant funding, and alter the parameters for reimbursement from Medicare and Medicaid. The National EMS Information System (NEMSIS) database serves as a platform for data collection for research into trends and could be used to assess value. Value in health care is usually defined as the impact of an intervention, or a PI, divided by the cost of the intervention or service. This concept could also be developed into a methodology by which EMS agencies reimbursement could be transitioned to a pay- for-performance model.

Quality assurance is defined as, “retrospective review or inspection of services or processes that is intended to identify problems.”³ In this process, the review begins after an event has occurred, and the focus is often on the actions of individual providers measured against some standard or threshold. Providers receiving feedback may consider it punitive or subjective. Some quality can be achieved with quality assurance, but the effect is often to settle for “good enough” if a subjective standard is met.⁸

CQI focuses on the improvement of processes, systems, or organizations as a whole.³ Individual providers may be the focus of education and training, but most focus is on the systemic problems with a process. The improvement process is data driven, and the focus is in education and improvement, not discipline.⁸

In medicine, CQI principles are seen prominently in clinical practice guidelines.⁹ Guidelines are developed using best practices to improve the processes of patient care. These guidelines help decrease the types of variations in clinical practice that can lead to poor outcomes. In EMS, providers practice understanding orders or protocols supplemented by online medical control orders. Protocols can be considered similar to clinical practice guidelines, though it is important to ensure protocols are based on up-to-date information.

With limited budgets in EMS, the focus tends to be drawn toward reacting to the present crisis. Thinking of quality in general is a proactive process. This makes planning, budgeting, and prioritizing quality improvement activities difficult. Quality assurance, at minimum, is often a requirement at the state level for ambulance service licensing/ certification.¹⁰ Many states require evidence of or participation in activities such as patient care report reviews, data collection, continuing education. Organizations may choose to go no further than the required quality assurance activities, but this will not result in improvement. Quality improvement starts with the deliberate decision by an organization to be proactive in improving the patient care it provides.

Since the 2006 Institute of Medicine report “Emergency Medical Services at the Crossroads” a greater emphasis has been placed on developing system-wide (and nation-wide) quality improvement initiatives with established benchmarks for PI. In addition to agencies’ and providers’ interest in ensuring high-quality patient care, and the desire to maintain regulatory compliance, there is also a possible direct financial consideration that can justify an increased focus on CQI. Based on the “pay-for-performance” reimbursement model that continues to become an ever-greater influence on health care finance, these PI are likely to become the basis for reimbursement in the future.

One way to evaluate care is by task performance. EMS protocols lend themselves well to this type of evaluation by providing benchmarks. A reviewer can turn to the appropriate protocol for a chief complaint and compare the protocol to the actual care performed. A similar task-based evaluation is common in practical skills testing. While this method is useful, the binary “did” or “did not” approach to procedures may lead to an oversimplification. It may also fail to recognize how well the procedure was performed, or whether it was done at the appropriate time during the encounter.

When a case is reviewed retrospectively, some tasks are easy to point out when they are done versus when they are not done. Spinal immobilization is one task that traditionally has been easy to review retrospectively when not performed. The lack of immobilization in the setting of a significant mechanism raises a red flag, which is easy for a reviewer to find. Conversely, it may be difficult for a reviewer to identify a case where spinal immobilization was performed though not indicated. Spinal immobilization will continue to be an important topic of conversation as the EMS community continues to focus on the iatrogenic effects of immobilization and has moved away from reflexive immobilization of all trauma patients.¹¹

Administering dopamine to a hypertensive patient is a clear error of commission. However, evaluating a patient with a mild allergic reaction who receives epinephrine inappropriately may be more difficult to evaluate. The patient may have been adequately treated with diphenhydramine, but the reviewer may be unable to determine this retrospectively from a case review.

Medication errors have been well studied in the hospital setting and are estimated to account for one of the largest portions of preventable medical errors.¹² While usually only one patient is being cared for in the EMS setting, the other medication “rights” still apply and errors can occur with these. A medication could be given in the wrong site, such as IV access obtained in the same arm as a fistula; the wrong concentration, such as epinephrine 1:1000 versus 1:10,000; the wrong route, such as IV versus IM administration; or the wrong medication, such as with two similarly shaped or colored vials. Evaluating the tasks associated with medication administration ensures that potential errors are recognized, and processes can be improved if needed.¹³

When evaluating the events that make up an error, a root cause analysis (RCA) style approach can be considered. The nature, magnitude, and the timing of the error are all potentially important to determining the root cause(s). RCAs usually require a team approach and it may be helpful to construct a patient care timeline from available data and documentation. In some cases, multiple root causes may be identified. As in RCA for production and business, the CQI RCA should result in identification of causes that can then be addressed by remediation, education, and institution of preventative measures. The goal is to reach proactive solutions, rather than simply deriving reactive ones.

Outcome-based reviews are important for all health care professionals. Outcome measures are especially difficulty for prehospital providers who have a single, brief interaction with their patient. There are some changes that can be measured in transport: return of spontaneous circulation (or loss of pulse), improvement in vital signs, and reduction in pain are all potential short-term outcome measures that can be identified within a single EMS patient encounter. However, these may not always reflect the patient’s long-term outcome.

Many EMS providers have traditionally held the myopic view that any patient who is “alive when we get to the hospital” is a success. In truth, a patient dying during transport because of an error, though critically important, is probably fairly infrequent. These events must be reviewed extensively when they do occur. Morbidity or mortality later on as a result of prehospital care is more likely. Improper oxygenation of a head injury patient, leading to a poor neurologic recovery, is one such example. Obtaining feedback from the hospital allows agencies to better understand the bigger picture and their role in the overall care of the patient.

Hospital feedback is especially important in missed diagnosis/missed identification of conditions. For example, an agency may believe it is treating ST-elevation myocardial infarction (STEMI) patients correctly if a review of their records shows that 100% of patients with a provider impression of STEMI are taken to a PCI-capable center. Unfortunately, such a review is limited to cases where the provider had correctly identified the patient condition. This type of review would overestimate compliance by only reviewing cases where a diagnosis was made. Without hospital feedback, the agency may miss cases of STEMI that were not identified in the first place and as a result taken to an inappropriate destination.

What cases are reviewed is key issue for any QA program. While some programs strive for 100% case review, resource constraints often hamper the ability to perform a meaningful review on all calls. A random sampling of calls is a good way to begin any review. By creating a sampling protocol that provides a mixture of call types and providers, the sample will reflect the overall composition of patient encounters. In addition, certain high-risk conditions, high-risk procedures and high frequency events may warrant increased scrutiny. A breakdown of procedures by risk and frequency can be useful in analyzing where a CQI program’s attention should be focused. A set list of triggers for 100% case review should be created by the CQI staff in conjunction with the medical director. An example of such a list is seen in Box 6-3; please note that a single case may fall under multiple triggers.