Managing Laboratory Test Use: Principles and Tools

Clin Lab Med 27 (2007) 733–748

Managing Laboratory Test Use: Principles and Tools Brian R. Jackson, MD, MSa,b,* a

Department of Pathology, University of Utah, 15 North Medical Drive East, Salt Lake City, UT 84112, USA b ARUP Laboratories, 500 Chipeta Way, Salt Lake City, UT 84108, USA

Enormous technologic advances have taken place in laboratory testing in recent decades. Literally thousands of analytes can now be measured with commercially available assays. There is a steady stream of new assays along with improvements to the accuracy of existing assays. In theory, test improvements should lead to improved patient care. Yet, development of a technically accurate assay is only the first step [1,2]. The benefit of a laboratory test is not defined by its accuracy or even by its correlation to a disease state. The benefit, rather, is defined by the improvement in a patient’s downstream health status. This requires among other factors that physicians order the test for patients in whom it is indicated, not order it when it is not indicated, and interpret the test results appropriately in light of other clinical factors. Although the study of test use has historically taken a back seat to the development of new and improved tests [3], what evidence exists suggests that use is far from optimal. The concept of utilization management, much like managed care itself, has acquired a negative reputation in clinical medicine because of its association with the insurance industry and restrictions on utilization. This is unfortunate. Modern health care requires coordination of an enormous range of complex services. Health care organizations have an obligation to patients actively manage these, ensuring that the appropriate services are delivered at the appropriate time. This article discusses the theory and application of managing use of laboratory testing, not in the sense of simply reducing testing, but in the sense of ensuring that testing is clinically optimized. Implicit in this discussion is the belief that improvement is possible, and in particular that laboratorians and others can work with ordering This work was supported by the ARUP Institute for Clinical and Experimental Pathology. * ARUP Laboratories, 500 Chipeta Way, Salt Lake City, UT 84108. E-mail address: [email protected] 0272-2712/07/$ - see front matter Ó 2007 Elsevier Inc. All rights reserved. doi:10.1016/j.cll.2007.07.009 labmed.theclinics.com

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physicians to change laboratory ordering practices. Changing physician behavior is widely regarded as too difficult, too resource-intensive, or too fraught with quality tradeoffs to be practical. In fact, though, there is a growing body of literature demonstrating that physician decision-making can be affordably improved, as long as interventions are based on an understanding of the conceptual framework in which tests are ordered, and particularly when multiple behavioral factors are addressed simultaneously [4]. Evidence for suboptimal use One study of academic medical centers found marked variations in the quantity of care provided to Medicare patients for several common diagnoses [5]. The quintile of centers with the highest overall use rates performed 60% more services than the lowest-use quintile. When these costs were subcategorized, diagnostic testing was the category with the largest observed variation (versus physician charges, imaging, diagnostic tests, minor procedures, and major procedures). This paper’s methodology of aggregating all laboratory costs by facility, however, almost certainly underestimates the degree of ordering variation for individual tests. Regional variation in ordering practices suggests but does not prove that some of those practices are suboptimal. A number of studies have attempted to more directly evaluate overuse, underuse, or misuse of laboratory tests. An observational study of diagnostic test ordering in a pulmonary clinic found that only half of tests ordered to make or exclude a diagnosis, and only a fifth of tests ordered to assess a known condition, were supported by prospective cohort studies or equivalent evidence [6]. Q-Probes surveys sponsored by the College of American Pathologists have found high rates of misordering for a variety of specific tests. In one survey, 25% of outpatient blood cultures (and 10% of inpatient blood cultures) were ordered only as a single tube [7]. In another, 25% of toxic digoxin levels were found to be caused by inappropriately timed specimen collection [8]. In a third, 5% of inpatients on unfractionated heparin therapy did not have any coagulation monitoring in the first 12 hours, and 13% did not have a platelet count within the first 72 hours [9]. A survey of California physicians found that fewer than half routinely screened 15- to 25-year-old women for Chlamydia [10]. The Third National Health and Nutrition Examination Survey revealed that 13% of participants with prior stroke or myocardial infarction had undiagnosed hypercholesterolemia, even though 83% of them had seen a physician in the previous 6 months [11]. Overall, a 1998 review of 44 published clinical audits of laboratory use found compelling evidence of significant misuse across a wide variety of tests [12]. Drivers of suboptimal ordering Although most decisions about ordering laboratory tests are at the discretion of individual physicians, these decisions take place within a complex

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framework involving patients, facilities, insurers, and other participants. The pace of technologic change is arguably the biggest factor contributing to suboptimal decision-making; others include economic pressures on physicians and the diagnostics industry, malpractice fear, overestimation of test accuracy, and cultural pressure [13]. Physicians today are caught between an exponentially increasing body of medical knowledge and a fixed amount of time for keeping up on that knowledge (the knowledge explosion). Primary care physicians are particularly affected by this, because of both reimbursement mechanisms and the wide range of conditions seen in primary care. In a 1999 physician survey, one in four primary care physicians indicated that they were expected to diagnose and treat a broader scope of conditions than they believed they were competent to address. In that same survey, 38% of subspecialists considered the scope of primary care to be too broad [14]. The information explosion in medicine has affected laboratory diagnosis at least as strongly as any other area. New assays can enter the United States marketplace with much less regulatory burden than prescription drugs, and so the number of both new and improved assays coming onto the market each year dwarfs the number of new prescription drugs. There are several thousand laboratory tests commercially available in the United States at present, with constant changes in the form of new tests, improvements to methods, and new or changed clinical guidelines for the use of these tests. This creates huge challenges for physicians who wish to keep up to date. Several studies have suggested that many information needs in clinical practice go unmet because of time constraints and lack of adequate information resources [15–17]. Not surprisingly, some laboratories have found it worthwhile to place a particular utilization management focus on new tests [18]. Impact of suboptimal ordering Diagnostic testing is a relatively upstream process in patient care. Virtually all of the clinical impact and much of the financial impact of a laboratory test is determined by how the test result changes patient management. In principle, a test can have no impact, positive impact, or negative impact on the care of a particular patient. In the no-impact category is redundant testing, such as when a test is inadvertently repeated. Depending on the tests analyzed and the strictness of criteria, from 8% to 30% of test orders may be redundant [19,20]. In general, redundant testing has neither clinical benefit nor clinical harm, and the financial harm is restricted to the cost of performing the redundant tests. In the negative-impact category are tests that trigger potentially expensive and dangerous diagnostic work-ups and therapies. Particularly when a test gives a false-positive result, it is not unusual for a patient to undergo a lengthy succession of additional tests to clarify the initial result. This has been referred to as the ‘‘Ulysses syndrome’’ [21].

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It is hard to estimate the average downstream costs resulting from inappropriately ordered laboratory tests, but it is likely to be substantial, particularly when expressed as a multiple of laboratory costs. By one estimate, the direct cost of laboratory testing accounts for less than 5% of health care costs, yet laboratory results drive 60% to 70% of major health care decisions (eg, admission, discharge, and initiation of therapy) [22]. Consider a hypothetical $50 laboratory test, which when positive leads to a $1000 biopsy or imaging study. If that test happened to be 95% specific (ie, 5% false-positive rate), then the total cost impact of ordering this test on a patient who does not need it is $50 þ ($1000 * 0.05) ¼ $100, or double the direct cost of the test. The noneconomic impact, both physical and emotional, of exposing patients to potential false-positives is also substantial [23]. Strategies for improving ordering Given the complexity of medical decision-making and the range of factors influencing decisions about laboratory tests, not to mention the heterogeneity of clinical settings in which tests are ordered, it is simplistic to think that there could be a single ‘‘magic bullet’’ solution to improving ordering. A mixture of complementary interventions is more likely to be successful, particularly when the interventions are matched to the culture, information technology infrastructure and other local factors [4]. Simultaneously addressing multiple participants in patient care, including providers, patients, organizations, and so forth, can provide synergistic effects [24]. The framework presented here includes pulled education (information provided in response to a request); pushed education (unsolicited information); structural changes; and analytics. Pulled education Frequent information needs arise during the course of clinical care, many of which go unanswered because of the lack of a convenient and reliable source of answers [15–17]. For questions relating to laboratory testing, pathologists and clinical laboratory scientists have valuable expertise. Busy clinicians, however, cannot afford to spend large amounts of time tracking down a pathologist, and in many cases need an answer immediately rather than hours later. The traditional mechanisms for accessing pathologist expertise, namely telephone and pager, are still important but are no longer sufficient. All laboratories, including reference laboratories, have an ethical responsibility to make their medical directors available for clinical consultation. Many laboratories, particularly in academic settings, have formal on-call services in which residents may play a key role. Others may simply publish pathologists’ telephone or pager numbers. Either way, ensuring that a physician can rapidly reach a pathologist whenever a testing question arises (ideally in 15 minutes or less) greatly enhances the clinical usefulness of the consultative service.

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A major limitation of one-on-one consultation, however, is that it is not scalable. A pathologist could, in principle, spend 10 hours per day answering physicians’ questions with no time left over for reimbursable work, and still only address a fraction of local laboratory test information needs. A more efficient approach is to provide clinical guidance on common questions in an easily accessible public resource, such as a Web site (Fig. 1) [25] and reserve one-on-one consultation for more unusual or challenging questions. Linking ordering and interpretive guidance to online test directories may improve the accessibility and visibility of this guidance. Relatively few laboratories have online test directories at this time, although the number is likely to increase [26]. Pushed education The biggest drawback of pulled education is that it depends on physicians to recognize an educational gap and then be motivated enough to address the gap. They have to know what they do not know, which is not always the case. An ideal system complements pulled education with a way of recognizing educational gaps and selectively pushing additional information out to physicians when and where it is needed. Note that with any such efforts it is critical that the educational messages be concise and wellintegrated into clinical workflows. Most doctors have a very limited amount

Fig. 1. ARUP Consult Web site.

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for reading time each week, let alone time for lectures. Furthermore, the effectiveness of such traditional continuing medical education approaches has been questioned. A recent review article on physician continuing medical education concluded that interactive methods, including academic detailing, audit and feedback, and reminders, are the most effective at changing physician behavior and improving patient outcomes, whereas more passive methods, such as lectures and printed materials alone, are unlikely to be of benefit [27]. The same article found, however, that the latter techniques remain the most widespread. One approach is to distribute written guidelines in conjunction with reports showing each physician his or her ordering volumes as compared with the ordering volumes of a peer group [28–30]. Fig. 2 provides an illustration of the type of report used at Group Health Cooperative to reduce use of several common tests in asymptomatic adults. Peer group data in this context can serve as a credible, achievable benchmark; such benchmarks have been shown significantly to enhance the effectiveness of physician performance feedback [31]. A more intensive approach is academic detailing, in which written materials and interactions with physicians (either one-on-one or in groups) are coordinated in a fashion analogous to pharmaceutical or medical device sales, but with the goal of promoting evidence-based care [32,33]. Combining this social interaction with written information is more effective than distributing the written materials alone, but is expensive to implement [34] and the additional intervention costs may exceed any savings [35].

Fig. 2. Laboratory use report card. (From LEPS Editorial Staff. Improving laboratory test utilization through physician report cards with feedback from leadership: an interview with Kim Riddell, MD. Laboratory Errors and Patient Safety 2006;2:4; with permission.)

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One of the best opportunities for pushing educational messages is through the laboratory reports already being sent to physicians. Most reports generated by laboratory information systems do not provide room for lengthy commentary, at least not without degrading their readability. This does not, however, preclude the use of concise footnotes to clarify the ordering indications for a particular test, recommended follow-up testing, and so forth [36]. Some laboratories have created ‘‘enhanced’’ reports that present multiple laboratory data in integrated, graphical format [37–39]. As electronic medical record systems become more web-friendly, laboratory reports will be able to include hyperlinks to additional information resources. Structural changes In some cases it is practical and desirable to bypass physician education (ie, to change clinical processes to make them less dependent on physician knowledge). Such interventions, where applicable, can have a much stronger effect on behavior than education [40]. These include standardizing and simplifying ordering processes, using information technology to support the ordering process, and establishing and enforcing ordering policies. Test menus and requisition forms One of the most straightforward mechanisms to influence ordering is through test requisition forms [41]. Taking a test off of a requisition form, particularly if a better alternative to that test is placed on the form, can markedly change ordering practices. Even reorganizing a requisition form to put more commonly indicated tests in more prominent positions can measurably impact ordering [42]. Displaying relative cost information alongside the test name can likewise influence test ordering decisions [43]. Computerized provider order entry systems offer analogous opportunities and are discussed next. Decision support through information technology Physicians depend increasingly on electronic medical record systems for managing patient information. Most such systems include capability for viewing laboratory results, and an increasing number allow online placement of laboratory orders. These systems can influence ordering behaviors in a variety of ways. One of the simplest is reducing repeat orders simply by making historic laboratory results easier to view at the time of test ordering [44]. A variety of more elaborate systems that directly interact with physicians to influence ordering practices have also been developed [45]. These can be thought of in two categories: systems that are linked to order entry and those that are not, although in practice there is substantial overlap. Computerized provider order entry provides a convenient opportunity for feedback simply by requiring orders to be placed in the context of

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a physician-computer interaction. Computerized provider order entry– based decision support is well suited for addressing test overuse and misuse. A number of studies have shown improvement in laboratory test and blood product ordering as a result of feedback systems tied to decision support [46–49]. Such feedback systems need to be selective in the orders they address, however, or else they risk alienating physicians by making the order entry process less efficient. Computerized provider order entry systems can also have perverse effects, introducing medical errors where none had existed previously [50]. So-called ‘‘clinical reminder systems,’’ however, are not necessarily tied to the order entry process. Many such systems have feedback messages triggered by patient demographics and medical history. For example, a system might identify female patients between 15 and 25 who have not had recent Chlamydia trachomatis screening, and flag their charts accordingly before any subsequent visits. Such systems are well suited to addressing underuse of tests for preventive care and chronic disease monitoring [24]. Ordering policies Although many laboratories accept orders for virtually any commercially available test as a matter of customer service to physicians, others place selective limitations on ordering. One widely used practice is to require pathologist approval for certain test categories, such as sendout tests exceeding a particular cost. This is time-consuming, however, and may be most applicable to teaching hospitals where pathology residents can discuss individual cases with the ordering physicians. When a laboratory’s medical director deems a particular sendout test to be medically questionable, it is reasonable to put a blanket restriction in place. Finally, some laboratories require physician offices to accept billing responsibility for certain expensive sendout tests. A number of hospitals, multispecialty clinics, and networks have found it useful to establish laboratory diagnostic oversight committees, which are closely analogous to transfusion committees and pharmacy and therapeutics committees [30,49]. In many cases this function is served through pathologist membership on clinical practice committees [18]. An advantage in setting laboratory policy through a multidisciplinary committee is the potential for easier buy-in among ordering physicians. In addition to setting policy, these committees can perform a variety of other functions including development, review, and dissemination of clinical practice guidelines; review of use data; and providing feedback to ordering physicians. Analytics Some utilization management efforts focus on the total quantity of test ordering [51]. A more medically rational approach is to address use of each individual test in the context of clinical care. It is impractical, however, given the huge number of laboratory tests commercially available today, for

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a laboratory to simultaneously actively manage every single test on its menu. It is likewise impractical to perform the massive chart review that is required to definitively establish appropriateness of every single order that a laboratory receives. The good news is that high level review of ordering patterns (ie, data analytics) provides an affordable, scalable approach to both these problems. For example, the appropriateness of free prostate-specific antigen orders can be estimated using the distribution of total prostate-specific antigen and patient age alone [52]. Appropriateness of consecutive orders of serum sodium can similarly be estimated using only the order dates and result distributions [53]. When patterns are identified that suggest suboptimal ordering, clinical pathologists and laboratory managers can investigate further as needed to clarify ordering practices. They can then focus their utilization management efforts on the subset of tests that are not being optimally used in their facility. The basic requirements for this approach include a searchable data repository, front-end data analysis tools, and personnel to develop and maintain the system. With regard to a repository, many laboratories have only the database contained in their laboratory information system; others have a separate data repository either for the laboratory itself or at the hospital level. Many commercial data analytics and data-mining tools are available, particularly for repositories based on any of the leading commercial database management systems. The level of expertise required for performing database queries depends on the software tools available. With some packages, a wide range of analysis can be performed by technologists and others without extensive database training, although initial setup may require more expertise.

Roles of specific groups Just as effective utilization management requires coordination of multiple approaches, it also requires coordination among the various participants in the laboratory diagnostic process. Each of the groups listed next has a different perspective and set of available resources, and each can play a constructive role in promoting high-quality laboratory diagnosis. Clinical pathologists The historic role of the clinical pathologist has included medical oversight for the laboratory along with consultation to clinicians. In many countries this consultative role continues to be prominent. In the United States, however, economic pressures have led to many clinical pathologists being spread thinly across numerous laboratories, leaving little time for consultation. In addition, medical direction of many smaller clinical laboratories is provided by generalists whose primary area of expertise is surgical rather than clinical pathology. Not surprisingly, United States physicians with questions about laboratory testing often turn to sources other than their local clinical

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pathologists. For example, one survey asked physicians what resources they used for information on HIV viral load testing. The most frequently cited sources were other clinicians, journal articles, and other publications; only 5% said that they either often or occasionally consult pathologists on this topic [54]. This is in spite of the fact that many physicians would like clinical pathologists to be more available for clinical consultation [55]. Effective and medically sound laboratory utilization management requires a rededication on the part of clinical pathologists to their consultative role. Some pathologists may fear that this will put them in conflict with local physicians, but it provides an opportunity to establish closer relationships with physicians while improving care [18]. Effective utilization management also requires that pathologists be true generalists and stay up to date on both technologic advances and practice guidelines covering the full spectrum of available tests. Some authors have proposed that an expanded role for clinical pathologists should include patient-specific consultative interpretations [56]. As currently practiced on the coagulation service at Massachusetts General Hospital, this includes review of laboratory results along with additional relevant data in the electronic medical record. The pathologist then issues a patient-specific interpretive report that is included in the medical record. This service has been well received at that hospital, with most clinicians reporting that it saved time and prevented diagnostic errors [57]. This model may be extensible to other areas of laboratory medicine beyond coagulation. Funding such an interpretive service may require that local payers be willing to pay for clinical pathology consultations. Laboratory managers Hospital laboratory managers play a pivotal role in balancing hospital administration’s pressure to control costs with the local clinical community’s need for responsive laboratory diagnostic services. With the support of their medical directors, laboratory managers can identify cost savings among overused and clinically questionable tests, while educating administration about the need to maintain or even increase support for testing areas that have a solid evidence base. Managers and their medical directors also have the opportunity during the budgeting process to remind hospital administrators of the enormous impacts on downstream cost and quality impact of laboratory testing. Finally, laboratory management can support diagnostic use and clinical practice committees by providing cost and use data and helping implement structural changes. Ordering physicians This article takes as its basic assumption that clinicians use laboratory tests in a manner that they believe best serves their patients. Virtually every medical technologist and pathologist has had experience interacting with

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physicians who do not appreciate oversight and feedback regarding their test ordering decisions. Such physicians, however, are almost certainly in the minority. Optimizing laboratory diagnosis requires both clinicians who are open to oversight and feedback, and pathologists who are not afraid to confront the ones who are not so open. The proposals in this article in no way minimize the importance of clinical judgment on the part of ordering physicians. Efficient, high-quality care requires that clinical decision-making take place close to the patient. A legitimate criticism of managed care in the 1990s was that excessive secondguessing of physician judgments delayed necessary care while driving up administrative costs. A better model is to support physician decision-making by making it as easy as possible for them to follow recommended practices, while allowing for individual deviations when patients ‘‘do not fit the mold.’’ Laboratories do need highly directive options at their disposal, such as the ability to refuse orders for an obsolete test, but such actions are always the exception rather than the rule. Reference laboratories Because reference laboratories have only an indirect relationship with ordering physicians (and in many cases do not even know the identity of those physicians, let alone have a reliable mechanism for contacting them) it is impractical for them to apply many of the techniques listed previously. Reference laboratories do have several advantages, however, which can allow them to play a complementary role in partnership with local laboratories. One is a broad set of data across multiple clinical settings, which allows benchmarking and other analytics. Another advantage is access to resources, such as information technology and marketing communications, which in many cases exceed what is available for hospital laboratories. A natural partnership, then, might see a reference laboratory providing analytics services and educational materials to a local hospital, whose pathologists can then follow-up with local physicians as necessary. In some ways this is analogous to the disease management services sometimes offered by pharmaceutical companies. Note that at least one such company has been accused of using its programs to circumvent prescribing controls by payers [58]. Transparency is critical in such an arrangement to ensure that the reference laboratory’s services truly promote evidence-based medicine. Developers of laboratory tests Although some might consider the test development role of the in vitro diagnostics industry to be purely technologic, their influence extends much further. In particular, decisions about evaluation methodology and marketing both have important downstream effects on the use of the tests they develop. Fryback and Thornbury [1] have proposed a useful hierarchy, which illustrates how the use of a test is dependent on a number of factors

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beyond the technology embedded in the test (Box 1) [2]. They also use this hierarchy to illustrate how efficacy at a particular level is generally dependent on efficacy at all lower levels, and does not guarantee efficacy at any higher levels. For example, a test cannot have good sensitivity and specificity unless it is reasonably precise. But a sensitive and specific test is not clinically useful if clinicians can make the diagnosis just as accurately based on clinical data, or if the therapeutic decisions are not affected by the test result, or if the therapy does not improve patient outcomes. One useful role of in vitro diagnostics vendors is in sponsoring and participating in clinical studies to measure these higher levels of diagnostic efficacy. Clinical trials are certainly expensive, particularly large-scale randomized trials comparable with those in the pharmaceutical and device industries, and it may be unrealistic to expect in vitro diagnostics industry sponsorship at that scale unless the regulatory environment requires it (as some have advocated [59]). But some level of clinical evaluation is critical

Box 1. Hierarchy of diagnostic test efficacy Level 1: Technical The ability to produce technically meaningful information Examples: precision, linearity Level 2: Diagnostic The ability to produce information that correlates with disease states Examples: sensitivity, specificity Level 3: Diagnostic thinking The ability to produce information that improves the quality of diagnostic decisions Example: relative improvement in diagnostic accuracy given other available clinical information Level 4: Therapeutic The ability to produce information that drives therapeutic decision-making Example: drug dosage guidelines based on test results Level 5: Patient outcomes The ability to produce information that improves patient outcomes Examples: lower mortality, shorter hospital stays Level 6: Societal The ability to produce information that supports cost-effective care Examples: reducing downstream costs of care, improving outcomes while remaining cost-neutral

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to the understanding of the clinical use of new tests. In vitro diagnostics vendors can also contribute enormously simply by being clear in their marketing materials about the level at which each test has been validated. Having high demonstrated sensitivity and specificity do not make it intellectually honest to imply to potential ordering physicians that a test has been demonstrated to improve patient care. Patients Patients are taking an increasingly active role in their own health care, as evidenced by the widespread use of Internet-based health information [60]. The optimal role of patients in laboratory test ordering is dependent on both the setting and the diagnosis in question. Wennberg [61] has proposed a framework for dividing health care interventions into ‘‘effective care’’ for which there is clear-cut evidence of benefit and a lack of substantial tradeoffs that would involve patient preferences, and ‘‘preference-sensitive care’’ for which multiple medically justifiable options are available and patient preference should ethically drive the decisions. Use of cardiac markers to diagnose acute myocardial infarction qualifies as effective care: most physicians are not comfortable asking a patient with chest pain to decide between troponin and creatine kinase MB fraction testing, and indeed most patients prefer that their doctor simply choose the more appropriate of the two. Patients can still play a productive role, however, in facilitating effective care. For example, an educated diabetic patient might help ensure that hemoglobin A1C is ordered at the indicated intervals. Prostate cancer screening, however, is preference sensitive. The widespread use of prostate-specific antigen testing for screening in the United States may be in part caused by physician enthusiasm for this test; patients who are provided with information about the tradeoffs in prostate cancer screening are significantly more likely to decline testing [62]. Direct-to-consumer advertising may play an important future role in preference-sensitive laboratory test use, particularly for high-end proprietary tests. If so, it is important for the pathology community to provide patients with scientifically balanced messages to counteract any potentially biased commercial messages. A natural mechanism might turn out to be provision of patient education materials that could accompany laboratory reports.

Summary For laboratory testing to achieve its potential for supporting high-quality patient care, tests need to be used in a scientifically and medically appropriate manner. Rapid technologic change alongside myriad clinical pressures makes it unrealistic for unaided physicians to stay up to date on the indications for all available tests. Laboratories and clinical pathologists can improve patient care by monitoring test use and then responding to

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