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Laboratory stewardship and test utilization


Abstract

Laboratory tests substantially impact clinical care, but their overuse, misuse, or underuse can cause patient harm and dissatisfaction, suboptimal patient care, and increased costs. Traditionally, the first consideration of pathology and laboratory medicine has been centered on optimizing the analytic phase of testing, which, of course, is critical for producing reliable and meaningful test results. Subsequently, it has become clear that specimen acquisition, transport and processing (preanalytics) and the accurate and timely reporting of results (postanalytics) substantially affect the reliability of test results. Finally, proper test selection (pre-preanalytics), and accurate interpretation of results (post-postanalytics) are the other important components of laboratory testing that impact value and outcomes. All of these functions are within the scope of practice for pathologists and clinical laboratorians, who are responsible for the overall quality of laboratory testing. This chapter outlines the reasons for suboptimal test use, lists potential outcomes of improper test use, describes how to create and maintain a test utilization or laboratory stewardship program, provides insights on the management of test utilization projects, and provides examples of specific interventions that can improve test utilization patterns. Finally, this chapter will underscore the importance of collaborative engagement of pathologists and clinical laboratorians with stakeholders to promote the optimal use and performance of laboratory testing from the moment testing is considered through to the clinical response to the results. In addition, because the area of Laboratory Stewardship is a relatively new and evolving field, the authors include examples of implementation of these practices.

Introduction and historical perspective

Health care costs are a major concern in all parts of the world with rates of expenditure growth exceeding available resources. As newer technologies and medications become available, many of them with major costs involved, there is a need for health care providers to consider the value of all health interventions.

In the United States, a transition from volume-based health care reimbursement to value-based models is well underway. These changes essentially limit the amount that will be paid for any particular procedure or treatment for particular diagnoses. The Medicare Access and CHIP Reauthorization Act (MACRA) of 2018 was implemented in part to incentivize clinicians for participating in value-based health care delivery. Health care providers, in fact, have already adjusted to this type of model with inpatient billing in the form of diagnosis-related group (DRG) payments. Although the billing and coding requirements are more complicated than presented here, for a particular DRG, the hospital is paid a set amount for taking care of a patient with a particular condition (e.g., hip replacement surgery). The concern with such a model is that health care organizations might reduce services to decrease costs and increase profits at the expense of quality of care. Payors have countered by not covering complications secondary to what they may view as substandard care. Examples include not covering hospital-acquired infections and readmissions that occur soon after discharge.

Diminishing the use of unnecessary laboratory tests, which increases costs without adding value, is one way health care leadership can decrease health care costs while improving patient care, satisfaction, and overall quality. Omission of needed testing is another concern that can impact the delivery of appropriate care and may be more common than overtesting. The main focus of quality systems in laboratory medicine has primarily involved optimizing analytical performance and to some degree improving the preanalytical and postanalytical phases of testing. Much less attention has been directed at addressing the quality of test ordering practices (pre-preanalytics) and the optimal use of results for best patient outcomes (post-postanalytics). Laboratory stewardship and test utilization management are terms used to describe these latter components of laboratory quality performance, which are described in this chapter with a focus on the pre-preanalytical component.

Laboratory-based professionals contribute significantly to patient care by providing high-quality, reliable test results on which diagnostic and therapeutic decisions are made. This is a considerable contribution to patient care, but the truth is that substantially more can be accomplished by increasing laboratory engagement in activities that precede and follow the analytic phase of testing. Greater engagement in preanalytics helps to ensure the correct specimen is collected in the proper manner, transported in a manner to maintain specimen integrity, processed promptly, and tested accurately. For example, it has been demonstrated that the preanalytic transit time is the most important factor influencing time-to-positivity of blood cultures; this is not because of the growth characteristics of the bacteria, but rather the amount of time the specimen is delayed before being placed on the instrument. In such an instance, time-to-positivity could be improved by decreasing transit time, a controllable preanalytic variable. Another example is the investigation of preanalytic factors that could be addressed to decrease hemolysis in blood specimens collected in the emergency department. Similarly, attention to the postanalytic reporting of test results can help to ensure that results are accurately reported in a prompt, timely, and user-friendly manner. Over the past decade, much has been done in the both the preanalytic and postanalytic space to improve test performance, reporting, and, subsequently, patient care.

The areas of more recent focus center on the reasons for testing (i.e., pre-preanalytics) and result interpretation and subsequent clinical action (i.e., post-postanalytics). For example, there may be substantial opportunities in population health management by the coordinated use of laboratory data in the postanalytic space. Engagement in these areas will require individuals with appropriate medical knowledge beyond that of test performance and, perhaps even more importantly, excellent communication, professionalism, and team-working skills. Further participation in the pre-preanalytic and post-postanalytic space serves to more completely engage the pathologist and laboratorian in patient care in a manner that is needed to further optimize healthcare delivery into the next decades.

POINTS TO REMEMBER

  • Health care costs continue to increase.

  • There are pressures to deliver high-quality care at a lower cost.

  • Laboratory stewardship initiatives can maintain or improve quality while lowering health care costs.

  • Laboratory-based professionals can improve health care delivery and lower health care costs through active participation in test utilization initiatives.

Causes of overutilization and underutilization

Inappropriate test ordering is common. One meta-analysis reported overall mean rates of overtesting and undertesting of 20.6% and 44.8%, respectively. Another study involving outpatients reported that only 49% of hemoglobin A 1c orders were appropriate, with 21% having been ordered too frequently (overtesting) and 30% having been ordered too infrequently (undertesting). The Choosing Wisely campaign was established by the American Board of Internal Medicine (ABIM) Foundation to promote better utilization of diagnostic testing. More than 80 medical societies have contributed more than 500 recommendations, many of which involve laboratory testing. However, there remains limited evidence-based support for optimal selection and frequency of testing for most analytes, and guidelines so far developed involve complex variability in test frequency recommendations which are dependent on specific clinical factors. This makes it difficult or impossible for testing guidelines to be effective. Even when policies are developed for optimal test ordering, implementation is difficult to support due to lack of functionality in laboratory information systems for expertly managing the flow of orders.

The reasons for underutilization, overutilization, and misutilization of laboratory tests are legion but, importantly, can be addressed in a variety of ways. Why would someone order a test that was not needed (i.e., overutilization)? From our experience, one of the most important reasons is that the provider did not know that a test was already ordered. This is particularly common in hospitalized patients who are being seen by both their primary team and consultants. A test previously ordered by the primary team may also be considered necessary by a consultant, who then reorders the same test. One may ask: Why didn’t they check to see what tests have already been ordered? As it turns out, complexities of ordering systems and the limited time physicians have to spend with each patient make this difficult. Although it is feasible to determine through computer searching what tests have been ordered, the fact of the matter is that clinicians are often too busy to stop and check. Instead, they order what they need for that patient and move on, assuming that duplicate orders will be addressed downstream. Unfortunately, in many instances duplicate orders are not detected and canceled, which leads to unnecessary duplicate testing. Although manual interventions may be used to reduce unnecessary testing, these incur a substantial toll in human labor, diverting highly qualified resources (e.g., medical technologists) from patient testing to the work of reviewing logs for duplicate studies. This is operationally inefficient and adds cost to an already overburdened health care system. Furthermore, when tests are canceled “downstream,” such as after receipt in the laboratory, the patient has already suffered an unnecessary phlebotomy or another collection procedure. This highlights the importance of stopping unnecessary testing at the point of computerized order entry before a specimen is collected.

Laboratory tests, like other diagnostic procedures, may also be overordered for fear of litigation. , Although this has been stated, it has not been encountered as a common reason in the experience of the authors of this chapter. Excessive ordering may also occur because orders are unnecessarily embedded in order sets or protocols developed by organization to facilitate ordering or to standardize practices. We have experienced this with the complete blood count (CBC) with differential (CBC w/ Diff). For example, a CBC w/ Diff may not be needed in a patient for whom a “Rule Out Myocardial Infarction” order set is being used; yet, if a CBC w/ Diff is included in that order set, then the unneeded differential will be performed for every patient with chest pain for whom this order set is used. Standing orders for testing to be performed at set intervals also contribute to excessive, unnecessary testing. Medical trainees have admitted that they will place standing orders (e.g., a daily order for CBC) for tests commonly performed in the inpatient setting so they do not forget to place the order each day the test is truly needed. It is a major failing if we are training new physicians who practice this way, resulting in the overphlebotomization of patients and a waste of health resources, rather than pausing to consider which tests are truly needed for patient care.

Overutilization, underutilization, and misutilization of laboratory tests can each be caused by a provider’s lack of understanding of the test. A thorough understanding of the “how,” “when,” “how often,” and “for whom” a test should be performed is critical for appropriate utilization. Recognition of the complexity of every test offered in the laboratory is simply not feasible for the new intern who is now responsible for placing patient orders. Therefore it is crucial to provide resources for these individuals in teaching hospitals, which may include readily available laboratorian consultation. There also needs to be a sea change in medical education regarding the traditional approach of many attending physicians who will deal harshly with residents who fail to order a test. The approach of residents and fellows ordering whatever they think may even be remotely needed in order to avoid criticisms of an attending is a paradigm that needs to change, and relies significantly on the approach of attending providers to trainees. Sedrak and colleagues have summarized these and other reasons residents perform unnecessary testing. A succinct attending/resident discussion after a patient encounter regarding what tests are needed could both remedy this cause of overutilization and provide many “teachable moments.” The lack of understanding of testing indicates the need for pathologists and clinical laboratorians to become even more engaged in medical education outside their department and to more fully participate in care delivery.

POINTS TO REMEMBER

  • Inappropriate test ordering is common.

  • There are many reasons for inappropriate test ordering; determining the root cause is important for designing interventions.

  • Advances in hospital informatics systems are needed to optimize test utilization.

  • An evaluation of order sets and standing orders, including daily orders, often disclose opportunities for improvement.

  • Readily available laboratory consultations may improve test utilization.

The laboratory stewardship/test utilization committee

The Laboratory Stewardship or Test Utilization Committee is a hospital- or health system–based committee that is concerned with the optimal utilization of laboratory tests and services. It should be as much focused on underutilization as overutilization. The objective of Laboratory Stewardship committee members is to develop and endorse sound policies and procedures for their institution that promote effective laboratory testing practices among its various stakeholders. The Pharmacy Formulary committee and Antimicrobial Stewardship committee are similar groups that serve as a model for committee structure and function. The following section contains guidance regarding the establishment and management of a successful Laboratory Stewardship committee.

The philosophy and charge of the committee

It is important for individuals of any committee to understand the charge of the committee and to determine how they can contribute. Although Mission and Vision statements are not mandatory, the development and periodic review of these help committee members to recall their reason for taking time out of an already busy day to participate. The presence of the committee charge denotes external support from senior leadership, which helps to lend credibility to the committee (see later). It is our belief that the underlying reasons for the existence of the committee should not be solely to reduce the cost of health care. Reducing costs is not an internal motivator for many, and focusing solely or predominantly on money “saved” may result in a loss of participant engagement. However, we recognize that reduced health care costs are an important by-product of eliminating waste and optimizing care delivery pathways and can be viewed as an ethical imperative because it frees up health dollars for other purposes.

Most health care professionals entered medicine to improve the lives of the patients they serve. These altruistic reasons should be the primary drivers for forming a Laboratory Stewardship or Test Utilization committee. It should be recognized that excessive phlebotomy is painful and stressful to patients, particularly those who are hospitalized and enduring this day after day. This practice may also lead to iatrogenic anemia, which has untoward consequences, such as poor wound healing, increased infections, and, in patients with underlying disease, cardiopulmonary compromise. ,

Another fact that should be considered is that performing even technically sound tests (i.e., tests with high sensitivity and specificity) in low-prevalence populations leads to extremely poor positive predictive values. Otherwise stated, there will be false-positive test results that may lead to additional testing, which could include radiologic studies or other expensive or more-invasive procedures. The avoidance of these deleterious effects on patient care, and the improvement of patient satisfaction and clinical outcomes should drive the need to intervene. Improving patient care, optimizing care delivery, and working to ensure best practices are used will always find a receptive audience and will generate enthusiasm in health care providers.

Leadership support and reporting structure

The Laboratory Stewardship committee should be sanctioned by the leadership of the institution and should have a defined reporting structure. This is important for a number of reasons. Foremost, it demonstrates that the appropriate use of laboratory tests is important to the leadership of the institution, which lends credibility to the initiatives. However, what if test utilization is not yet on the radar of institutional leadership? In this case, the starting point is to convince leadership, in an evidence-based manner, that these initiatives are important for high-quality patient care, satisfaction, and safety, while contributing to cost-savings in health care delivery. Leadership support is also important because the committee will often be instituting test ordering changes that affect the entire health system. Once the reporting structure is established, it is recommended that regular meetings are scheduled with the individual or committee to whom the committee will report. Laboratory Stewardship committees commonly report into the hospital quality structure or medical operations. There is often a dual reporting to the Chair of Pathology and Laboratory Medicine or equivalent lead of laboratory services. This, too, is important because contributions from testing content experts will be needed when changes are proposed.

The engagement of physicians and other caregivers is also critical. Although “mandates” from hospital or medical leadership may eventually be implemented, they may be resisted. The goal is to introduce and/or ensure that best practices in test utilization are undertaken. Although it would be optimal if every test were used correctly every time, this is unrealistic. We are foremost concerned with aberrant utilization that could cause patient harm. After this, we are concerned with optimizing utilization to enhance patient care outcomes, increasing patient satisfaction, and decreasing unnecessary health care costs.

The solicitation of individuals from different departments, through their departmental chairs/directors, who are interested in laboratory stewardship/test utilization initiatives, is a good way to form the core group of committee members (see “Committee Composition” later). One of the lessons we have learned over the years, which has been confirmed by others, is that physicians on the committee are often unlikely to make decisions about the practice of other colleagues outside of their subspecialties (e.g., a rheumatologist is unlikely to be proscriptive to a surgical oncologist), and upon reflection, they should not do so. However, any physician should be able to raise questions regarding why certain tests are needed or why they are repeated at certain intervals (i.e., what is the evidence?). A recommended solution for addressing subspecialty issues is to form subspecialty task forces of content experts to address issues that arise within a subspecialty. For example, representatives from Infectious Diseases, Clinical Microbiology, and Immunology/Immunopathology would be core members of a task for assembled to address inappropriate testing for Lyme disease. In such a situation, a member of the committee, either with or without content expertise, can act as a facilitator to work matters to a conclusion.

Organizational structures/committee composition

The physicians on the committee function in a number of roles. Foremost, physician leadership on the committee and/or subteams is important because a physician-to-physician conversation is often necessary. The committee may be led by a single physician chair, or there may be co-chairs. There are benefits to having a clinical co-chair and a pathology co-chair because each brings a different set of competencies and perspectives to the committee and initiatives. It is also important to have physicians and clinical laboratory scientists as part of the Laboratory Stewardship committee core team. These individuals will contribute to issues encountered daily within their practices and will lend a global (systems-based) perspective to the committee. As mentioned elsewhere, it is beneficial to have providers who may act as ad hoc members, participating with standing committee members in their areas of content expertise.

Nonphysician caregivers are critically important for the success of the Laboratory Stewardship Committee. These include, but are not limited to, genetic counselors, members of the informatics team, statisticians, a representative from finance, nurses, medical administrators, and physician assistants, among others.

Genetic counselors perform a number of activities related to test utilization at institutions wherein there is a substantial amount of genetic testing and should be included if these tests are being considered. These individuals assist patients in obtaining medically necessary genetic testing and provide appropriate pretest counseling while remaining sensitive to the high cost of these tests. More recently, subspecialization has occurred within this group, with individuals concentrating on laboratory-based genetic counseling. These individuals provide heighted expertise in the review of genetic tests and are highly effective in both ensuring the patient receives the appropriate test while decreasing costs by intervening on unnecessary genetic testing that is often sent to reference laboratories. Moreover, genetic tests may require preauthorization from payors. In some practices, genetic counselors have assumed responsibility for obtaining preauthorization, whereas in other settings they serve as resources to members of the preauthorization team that resides in finance or the clinical laboratory.

Members of the informatics team are critical partners in laboratory stewardship for a variety of reasons. Foremost, these individuals are often responsible for acquiring the data that will be used by the stewardship team to justify a new test utilization initiative. There is need for a good information technology (IT)-clinical interface, and this may be through clinicians who understand the IT system and/or IT specialists who understand the clinical use of the data. A failure to properly understand the data can jeopardize a project. IT is needed at all stages of a project, usually including implementation, as well as ongoing review for effectiveness. Once high-quality data are obtained, the clinical meaningfulness of the data should be determined. This is undertaken by content experts who take into account the clinical scenarios in which the data were obtained. For example, one may ask: Is more than one CBC per day necessary for an inpatient? Such a question cannot be answered without understanding the clinical context. Repetitive CBCs are probably not needed in a patient with uncomplicated pneumonia but may be in a bleeding trauma patient. Such a thorough and thoughtful review of the data will aid in the decision as to whether or not an intervention is warranted. If an intervention is deemed necessary, then high-quality data will serve as a baseline against which the effectiveness of the intervention will be measured.

Once an intervention has been completed and substantial data are available, a review of the effectiveness of the intervention should be undertaken. These data will again be provided by collaborators in the hospital informatics area, reinforcing the importance of a close working relationship with this group. Once sufficient and high-quality postinterventional data are obtained, it must be analyzed. It is important to have access to individuals who are competent in statistical methods. Similarly, it is important to have individuals from finance, either available when needed or as members of the team who can determine the financial impact of the interventions. There are a number of pitfalls in determining the financial impact of interventions, and it is important to realistically calculate cost-savings.

Many of the other nonphysician members of the team will be critical to operationalizing the interventions. These include administrators, nurses, and advanced practice providers (APPs; e.g., physician assistants and nurse practitioners). Administrative representation is particularly important if additional personnel or other resources are needed, to remove barriers, or if new assignments must be made to an employee’s job duties. These individuals, working with finance, help to estimate the cost of the undertaking and the impact of intervention. Nurses and APPs are particularly helpful for understanding the current state (i.e., what is actually happening on the floors and clinics) and to assist with implementing certain interventions. These individuals represent champions on the floors, who can present information at local huddles and provide onsite training as necessary. Similarly, individuals with high level communication and change management skills can help to ensure a smooth implementation of committee interventions and avoid surprises and even potentially angry responses from affected individuals who were not properly notified of changes that affect the way they practice.

POINTS TO REMEMBER

  • The Laboratory Stewardship Committee should have institutional support and a reporting structure.

  • Improving the health of patients should be the primary driver of the committee; cost savings is a secondary gain.

  • Clinical and laboratory subspecialty experts form a knowledgeable and effective taskforce when addressing test utilization within their scope practice.

  • A multidisciplinary Laboratory Stewardship committee, consisting of physician and nonphysician care providers, administrators, informaticists, and others, is recommended.

Project life cycle

Once a Laboratory Stewardship committee has been active for a while there will be a number of ongoing projects in various phases of accomplishment. This complexity underscores the need for an efficient and well-organized project manager. The following section highlights the three major phases and important subcomponents in the project life cycle of a test utilization committee. Giving due consideration to each of these will help to ensure a successful program. These phases are:

  • Project Identification and Confirmation

    • Project identification

    • Data acquisition and review

    • Interventional strategies review and selection

  • Interventional Planning and Execution

    • Communication and change management

    • Exit strategy

  • Impact Analysis

1. project identification and confirmation

There are countless projects that could be undertaken by a Test Utilization committee. Therefore the question often becomes: Where to start? When first starting a Laboratory Stewardship committee, it is important to choose initial projects that are likely to succeed, the so-called low-hanging fruit. Success, which can be demonstrated by outcomes (see later), is important in the early stages of a new program to build credibility. Success also builds confidence within the team that they can accomplish meaningful change. This credibility, from a growing track record of success, will also prove helpful in continuing current support from institutional leadership or even obtaining additional administrative or project manager support.

Beware of the team members who are replete with ideas and suggestions that the committee should do but do not expend energy to assist with these projects. It can be useful to ask how they would like to approach the proposed project. If their response is unclear, consider thanking them for the recommendations and place these in a “parking lot” until such a time when resources are available to address their recommendation. Members of the committee should be there to contribute, as well as generate ideas for the committee. So then, how to identify projects?

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