- Email: [email protected]
Management structure: Establishing a laboratory utilization program and tools for utilization management
Clinica Chimica Acta 427 (2014) 118–122
Contents lists available at ScienceDirect
Clinica Chimica Acta journal homepage: www.elsevier.com/locate/clinchim
Management structure: Establishing a laboratory utilization program and tools for utilization management Christine Snozek, Erin Kaleta, James S. Hernandez ⁎ Department of Laboratory Medicine and Pathology, Mayo Clinic Arizona, 13400 E Shea Boulevard, Scottsdale, AZ 85259, United States
a r t i c l e
i n f o
Article history: Received 10 August 2013 Accepted 20 September 2013 Available online 27 September 2013 Keywords: Utilization management Overuse, misuse and underuse of laboratory testing Effectiveness Efficiency
a b s t r a c t As laboratories are challenged to do more with fewer resources, the pathologist and laboratory director will play a greater role in improving the effectiveness of the laboratory, as well as addressing the overuse, misuse and underuse of laboratory testing. We describe the necessary characteristics for pathologists and laboratory directors to successfully lead utilization efforts, as well as key leadership tools and essential steps in creating a utilization management program. When we established a laboratory test utilization program de novo, it became clear how important the laboratory director was in guiding those initiatives by working with stakeholders outside of the laboratory, particularly clinicians, nurses and administrators. © 2013 Elsevier B.V. All rights reserved.
1. Rationale for establishing a utilization management program In the past laboratories were rewarded for performing more tests and charging for higher test volumes that resulted in greater revenue. This is typically called practicing to volume. Given recent economic concerns and debate over healthcare spending, laboratories are increasingly tasked with providing more services with the same or less revenue. This shift in focus from performing many tests to performing only the necessary tests has been termed practicing to value. Utilization programs are a growing part of shifting the culture of laboratory medicine from practicing to volume, to practicing to value. There are several key concepts related to any discussion of laboratory utilization. The United States Congressional Budget Office [1] defines the following: Overuse. Overuse occurs when a service is provided even though its risk of harm exceeds its likely benefit—that is, when it is not warranted on medical grounds. Underuse. At the same time that some services are overused, others do not get provided even though they would have been medically beneficial. Misuse. That term includes incorrect diagnoses as well as medical errors and other sources of avoidable complications. Utilization management. Utilization management (UM) represents a broad array of techniques designed to influence the consumption of health care services, usually with the objective of promoting cost containment [2].
⁎ Corresponding author. Tel.: +1 480 301 8606; fax: +1 480 301 8372. E-mail address: [email protected] (J.S. Hernandez). 0009-8981/$ – see front matter © 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.cca.2013.09.026
Efficiency and effectiveness. “In the management literature, efficiency is often associated with performing activities as well as possible or ‘doing things right’ whereas effectiveness is often equated with the proper selection of the activities or ‘doing the right things’” [3]. Essentially, the goal of a laboratory utilization program is to employ UM techniques to curb use of tests and laboratory products (e.g., blood products) that are over-utilized, increase use of tests and products that are under-utilized, and correct misuse of tests and products that are ordered incorrectly, at the wrong time, on the wrong patient, or at the wrong frequency. There are few guidelines in the literature on establishing successful laboratory test utilization programs other than descriptions of local or regional efforts in both community hospitals and academic medical centers, based primarily on perceived overuse (over-utilization) [4,5]. However, underuse and misuse are also important aspects to consider when evaluating test utilization. In the United States, hospitals are capitated for each Diagnosis Related Group (DRG). In addition, with the passage of the Patient Protection and Affordable Care Act (so-called “Obamacare”) [6], there are concerted efforts to have laboratory directors move the laboratories from being revenue centers to being cost centers. In essence, hospitals are reimbursed a set amount for the care of each patient according to the DRG, regardless of the volume or intensity of services provided. This is meant to force not only efficiency, but also effectiveness, by limiting reimbursement for healthcare expenditures. Lab tests for hospitalized inpatients are included in the DRG. Since this is a capitated patient population, it should be evident to the ordering providers that the more is spent on laboratory tests, the less is available for other services under the DRG system.
C. Snozek et al. / Clinica Chimica Acta 427 (2014) 118–122
However, in many areas, efforts to limit excessive testing for inpatients are relatively new and fairly basic. Evidence for this is provided by the lists of “Things Physicians and Patients Should Question” published as part of the American Board of Internal Medicine's Choosing Wisely initiative [7]. Of note, the Society of Hospital Medicine (SHM) published 5 recommendations, two of which pertain to laboratory utilization: “Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms of active coronary disease, heart failure or stroke”, and “Don't perform repetitive CBC and chemistry testing in the face of clinical and lab stability”. To most individuals in the laboratory these points are common sense, yet the SHM felt they warranted specific recommendations to hospital providers. Obviously, there is a gap between the laboratory and the clinical practice; effective utilization programs must overcome this breach to improve patient care. Fortunately, UM efforts are not completely foreign to labs. Blood banks have been monitoring blood product usage for decades. Lately, some institutions have created electronic approaches to verify whether patients meet specific criteria for various blood products, or to restrict higher cost blood products, requiring explicit approval from the laboratory director or transfusion medicine physician before dispensing [8]. Additionally, there are numerous examples published for monitoring send-out practices, particularly costly testing panels. Ordering of these panels can be streamlined into algorithm-based ordering practices, where reflexive testing is dependent on results from first tiered tests, in an effort to reduce ordering redundant or superfluous tests [9]. The challenge is to extend these initial efforts into more widespread UM of laboratory services. Utilization programs could exist in many areas, including tests performed in the clinical laboratory, products ordered from the blood bank, or molecular characterization of anatomic specimens. For simplicity, this article will refer to “laboratory test utilization” to encompass all aspects of testing or products typically managed by departments of laboratory medicine and pathology. Similarly, the terms pathologist and lab director will be used interchangeably to refer to the individual with scientific and clinical oversight of the test utilization program, regardless of degree or field of expertise. 2. Characteristics of the pathologist or lab director responsible for test utilization Laboratory testing UM is still in its infancy in the United States. However, there are some common elements in the utilization programs that have shown success. One of those elements is full engagement by a knowledgeable laboratory medical director [4]. Successfully steering a test utilization program requires a pathologist or lab director to demonstrate strong scientific, communication, and leadership skills. The individual should have sufficient knowledge of the specific areas included in the utilization program to make critical judgments — it may be difficult for an anatomic pathologist to weigh the necessity of an esoteric coagulation test, for example, or for a blood banker to assess proper utilization of a chemistry panel. The utilization program director must be a subject matter expert in the clinical laboratory, and capable of calling on experts in those areas in which he or she has less knowledge. To serve effectively, the pathologist or lab director must be respected by and have credibility with the laboratory, the clinical practice and the administration. Credibility is essential for the director's role in change management. UM programs always include an element of change; the most successful programs are those which move the culture of test ordering to one of optimizing clinical practice rather than simply limiting choices. The pathologist must have a good understanding that effective test utilization makes the local healthcare system stronger and improves patient care. He or she must also be able to communicate this concept clearly, and to work with physician leaders, residents, fellows, nursing, and administration to build the local infrastructure and methodology to optimize test utilization.
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Communication goes both directions: the pathologist or director must be willing to listen to the medical staff, who often feel that they have valid reasons for ordering a test the laboratory considers outdated or over-utilized. Listening does not imply that the providers' concerns will trump the laboratory's rationale for change. Instead, bidirectional communications are meant to establish a collegial atmosphere for discussing data and practice needs. These face to face discussions can also guide the pathologist in an important aspect of change management, namely knowing when and how far to push necessary changes. If providers are adamantly opposed to altering a particular practice, it may be wiser to first gain credibility by shifting focus to a less objectionable area of utilization, then revisiting the controversial topic at a later date. The director must work to establish trust. The pathologist must be able to use both intrinsic and extrinsic motivators to change provider behaviors regarding test utilization. Extrinsic motivators include the ability to use data from the local system to provide credible, practice-specific feedback to ordering providers. Deidentified, provider-specific utilization data enables each clinician to examine his or her own ordering patterns compared to peers and to self-adjust accordingly. Intrinsic motivators include providing persistent and persuasive guidance that gradually results in providers striving to order the right tests for the right indications at the right frequency. This guidance leads to a culture of regularly including test utilization considerations as part of optimal patient care. 3. Steps for establishing a test utilization program 3.1. Recognize the need Moving from the subjective desire to establish a utilization program to an objective reality requires data. The data acquired to support the need for UM will likely steer the format and targets of the program, and can often be used to gain clinical and administrative acceptance, as well as justify funding and resources. A laboratory can compare its institution's ordering patterns against other medical centers, through literature review, personal communication with colleagues, or benchmarking test utilization patterns with a multi-site data source such as the University HealthSystem Consortium. As an alternate or complement to this, a laboratory can compare against itself over time to assess trends in ordering patterns. Possible metrics range from the generic, e.g., number of tests per inpatient discharge or outpatient encounter, to the specific, e.g., charges for genetic tests sent to reference laboratories, volumes of particular tests suspected to be over-utilized, and number of tests per patient with a given diagnosis. 3.2. Prioritize initial goals Common goals for UM include cutting laboratory costs, improving laboratory efficiency, increasing payer reimbursement, refining provider ordering patterns, or reducing unnecessary testing. These objectives are often inter-related: for example, eliminating orders for an outdated test can save the lab reagent costs and technologist time. However, the relative importance of each goal will likely not be the same for different members of the project team. The discussion of priorities is important for the formation of the test utilization project; ultimately, it may be the responsibility of the pathologist or lab director to define the primary purposes of the utilization program. It is important to recognize that the goals of a UM program will likely evolve over the life of the project based on factors such as experience and provider feedback, but the initial objectives should be clearly stated as they will steer the program's structure and early targets. 3.3. Choose framework The structure of a laboratory utilization program can vary around a large number of parameters. For example: should it evaluate ordering
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practices for inpatients, outpatients, or both? A limited number of practice locations, or all practices within an institution including remote primary care sites, urgent care clinics, etc.? In-house performed tests, send-out tests, or both? Laboratory tests, blood products, pathology services, or all of these? These decisions must be made while keeping available resources in mind, particularly the time and funding of laboratory directors, lab staff, and information technology (IT) as well as the cooperation of administrative and clinical colleagues. Larger projects can be facilitated by inclusion of additional personnel such as project managers, individuals with coding and billing expertise, and especially residents or fellows. 3.4. Understand ordering system To effectively address test utilization, those responsible for evaluating ordering practices must first understand how providers order tests. Key questions include: are orders placed electronically or manually? Are they chosen from pre-defined order sets, i.e., groups of tests organized by clinical practice or indication, or individually from the full test menu or a provider's “favorites” list? Can others on the care team (nursing, residents, or attending physicians) see what orders have already been placed, or are pending/future orders difficult to find in the ordering system? This knowledge may steer project targets and interventions. For example, removing tests from pre-defined order sets may rapidly discourage providers from requesting those tests unless they are specifically required for a given patient. 3.5. Outline plan Utilization programs can be very resource-intensive, particularly in terms of IT. The availability of IT and lab resources, along with the project goals and framework, will drive the subsequent steps of initiating a test utilization program. With sufficient IT capacity, it is possible to pull a large amount of data from the laboratory information system or electronic medical record to create a database for numerous utilization projects. If resources are scarce, it might be more practical to acquire data for a limited number of individual projects, starting with lowhanging fruit such as high-volume tests with poor reimbursement rates. Ultimately, goals for intervention following test utilization may be IT resource dependent as well; for example, changing accessibility of particular tests in order sets, or initiating pop-up messages regarding ordering patterns. It is therefore key to understand the availability of local resources when outlining a UM plan. 3.6. Initiate pilot studies Regardless of resource availability, it is advisable to start with a small number of relatively simple projects. Pilot projects can be quite useful for refining data acquisition parameters, identifying unanticipated requirements or roadblocks, evaluating what clinical input is required, and creating mechanisms for communicating findings to the laboratory, administration, or clinical practice. If resources are limited, pilot projects might also be helpful in gaining acceptance of and funding for additional, larger utilization efforts. Studies should include planning for follow-up. For example, once providers are educated on proper utilization of a specific test, re-evaluating the data shortly after the education and then 6–12 months later can indicate whether the change was adopted long-term by clinicians, or if they reverted to the previous practice. 3.7. Evaluate efficacy As pilot studies are ongoing or nearing completion, the medical director should take time to review them, with an eye toward improving the process for future studies. Were the chosen projects large enough to provide noticeable benefit, but small enough to handle with available resources? How effective was the data pull strategy — was all necessary
information accessible, without much extraneous material? Were the correct clinical partners involved, and at an appropriate time? Regardless of whether a given project was successful or not, it is often possible to find aspects that could be done better in future efforts, leading to an iterative improvement of the UM program as a whole. 4. Tools for test utilization programs Key to the success of any laboratory utilization program is lab test formularies, test algorithms, and the use of reliable data generated from the local informatics of the system. Detailed discussion of the power of informatics in improving test utilization is provided later in this special edition, as are focused articles on lab test formularies, test algorithms, and other specific tools for utilization programs. Although the pathologist should provide medical and scientific oversight of these resources in designing a UM program and monitoring its implementation and effectiveness, these tools will not be covered extensively here. Rather, this section will focus on the communication and management tools pathologists and other laboratory leaders will require to direct the culture of laboratory testing toward practicing to value. Perhaps the most important role of the laboratory director in UM is as a liaison to providers. Successful culture change starts with communication between the laboratory – often routed primarily through the lab director – and the clinical practice. A utilization program depends on the willing participation of the formal and informal leaders of the clinical practice, especially those who order many tests. This includes division and department chairs, residency and fellowship program directors, and education staff. It is nearly impossible to effect significant change if the clinical practice is not integrated but rather is comprised of a collection of individual practices. Several UM tools can be quite useful for shifting test utilization culture within the clinical practice, including readily available access to peer-reviewed literature or expert opinion on a topic; short educational learning points; and provider-specific scorecards. For larger UM projects, it is helpful to include project managers, since they are experts in change management tools, tracking changes, and ensuring that projects are meeting goals on time and on budget [10]. As the UM program matures, relatively strong measures may be implemented, including limiting send-out reference tests to a select group of CLIAcertified laboratories and establishing a lab test formulary or test review committee [11]. An understanding of certain human factors is key to effective leadership of a UM program, including knowledge of personality types, learning styles, and generational differences. Some of the tools needed for UM are novel for many pathologists and scientists, and include negotiation. Consideration could be given to developing a podcast or video that shows vignettes about how a pathologist or scientist “negotiates” with a clinician who insists that a test is needed when the literature-supported evidence indicates otherwise. Since much of the UM efforts are iterative, it is important to celebrate achievements and provide feedback about progression of utilization initiatives to encourage forward momentum. For example, presentations, abstracts, white papers and peer-reviewed publications can be used for both internal practice and for external distribution. The laboratory can create a website that categorizes current efforts and completed projects so that all practices can continuously learn from others' accomplishments. Sharing best practices allows others to learn about successes in UM since this is a new endeavor for many labs. In particular, successes in creating rational use programs for expensive tests such as genetic and genomic send-outs are especially instructive. 5. Role of the pathologist or lab director in the test utilization program The lab director should be intimately involved in all aspects of establishing and maintaining a utilization program. In addition to
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providing scientific guidance for the steps outlined above, the lab director, whether a pathologist or a laboratory scientist, has several other leadership roles. He or she is responsible for establishing deadlines to eliminate tests that have strong published evidence against their use. The director should support projects in all areas to optimize the process of improving test utilization; successes in Transfusion Medicine in improving blood product utilization in many local healthcare systems can serve as a template. It is important to note that support entails ensuring all projects have sufficient resources for data mining and other key activities. If individual utilization efforts stall, the director or pathologist should investigate the reasons why, and consider using project management expertise to bring these projects to completion. As a link between the laboratory and the clinical practice, the pathologist is integral in identifying physician partners to serve as formal and informal leaders in test utilization efforts. Well-respected providers who are proponents for improving utilization can facilitate communication from the laboratory to their peers in the practice, and are critical in gaining acceptance from the clinical community as a whole. Cooperation with the clinical practice can also enhance educational opportunities, particularly for residents and fellows. The Accreditation Council for Graduate Medical Education (ACGME) requires residents and physician fellows to examine their practice patterns and to self-adjust based on what they learn. Many test utilization projects fall into the category of Practice Based Learning and Improvement, one of the key ACGME objectives for self-assessment to meet certification requirements [12]. The pathologist must establish multidirectional communication among the laboratory and clinical leaders, administration, and nursing. The goal is to facilitate a team approach that includes subject matter experts in multiple disciplines, and clinical colleagues who are interested in changing ordering practices. The medical director should consider engaging colleagues in laboratory medicine and pathology that have been successful in building their own test utilization programs and improving collaboration with clinical colleagues. It is important to emphasize the process of how to work with providers to change behavior, rather than merely focusing on the details of what needs to be changed. Systematic improvement of ordering processes as well as collegial guidance are necessary for rapidly effecting the desired ordering patterns, i.e., making it easier for clinicians to order the right test, for the right patient, for the right indication, at the right frequency. 6. An example of a laboratory UM program Concern regarding the perceived over-utilization of some tests and an audit of our testing patterns resulted in a project in 2011 to optimize ordering habits to minimize unnecessary repeat laboratory tests. Our test utilization program was established with a focus on decreasing the number of high volume, high cost tests while maintaining appropriate patient care. There was a deliberate attempt to employ evidencebased medicine to move from practicing to volume to practicing to value. Test utilization studies in our practice were initiated to address concerns for over-utilization. Tests that were frequently being underreimbursed under the DRG cost structure were identified to recognize high impact areas for test-utilization studies. Analysis of our internal financial data showed that some tests consistently had payment denied due to insufficient justification for ordering the tests or for performing the tests too frequently, including complete blood counts, magnesium, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). In cooperation with nursing informatics and financial personnel, a database was created to capture utilization information from the electronic medical record, including admission dates, location and length of stay, reason for admission, tests and blood products ordered, ordering physician, and laboratory test results. A complicating factor for UM in our system is the availability of recurring order sets, where a single order is placed that allows for repeated testing at predefined time intervals. The database includes the date an order was placed and when the test was
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resulted, allowing for identification of such recurring orders. This database was originally populated with one year of data, and is added to quarterly. Given predetermined criteria, the database can be filtered and queried, depending on the needs of the test utilization project. As an example, this database was utilized for investigating ordering patterns for NT-proBNP. Studies have demonstrated that the utility of NT-proBNP lies with identifying patients with congestive heart failure (CHF) and aiding in staging of patients with confirmed CHF. There is limited use in serial monitoring of NT-proBNP for trending of disease progression or improvement due to large intra-individual variability of this marker. The guidelines for CHF [13] recommend a single measurement of NT-proBNP per hospital stay. The utilization database was queried to determine the frequency of NT-proBNP orders. In 2011, of 2630 NT-proBNP tests ordered, 62% were repeat orders within one hospital stay, 40% of which were placed via recurring order sets. Literature guidelines [14,15] regarding the reference change value needed to show clinically significant changes in NT-proBNP were used to define whether serial testing was medically indicated. Of the over 1600 repeat orders in 2011, less than half showed a clinically significant change compared to the first measurement. Lab orders placed via recurring order sets were less likely to exceed the reference change value than were orders placed independently during a single stay. These findings were returned to the chair of the division that ordered the majority of NT-proBNP tests; the chair subsequently shared the deidentified ordering patterns with the ordering providers. This provided evidence-based information about ordering practices within their division, allowed for education about test utilization, and raised awareness of over-use of that particular laboratory test. A robust ordering database offers a post-education assessment tool, where similar studies can be performed after notifying providers of their activity on a periodic basis to potentially curb over-utilization of key tests. This study provided the model for future UM studies within our institution which can be used in a variety of situations across the testing menu. 7. Conclusion Simply put, UM efforts cannot succeed without a knowledgeable and engaged pathologist or laboratory scientist director with strong leadership and communication skills, as well as the ability to manage change and provide motivation to a large collaborative team across the medical practice. Beyond simply imparting medical and scientific expertise, the director must serve as an effective liaison to providers and administration, to steer the cultural shift toward including utilization considerations in daily practice. The goal of UM is to use electronic resources to monitor usage and necessity of testing and laboratory resources. A successful method for developing these projects uses a multidisciplinary approach that engages a combination of laboratory scientists, physicians and system analysts to map out guidelines that are optimal for patient care, efficiency of clinical service and practicing to maximize value of care, as opposed to volume.
References [1] United States Congressional Budget Office. The overuse, misuse, and underuse of health care 2012. [2] Wickizer TM, Lessler D. Utilization management: issues, effects, and future prospects. Annu Rev Public Health 2002;23:233–54. [3] Drucker PF. An introductory view of management. New York: Harper College Press; 1977. [4] Hernandez JS, Plapp FV, Essmyer CE, Forsman RW. Successful models for shaping test utilization patterns in academic and community hospital settings. Clin Leadersh Manag Rev 2009;23:E5. [5] Plapp FV, Essmyer CE, Byrd AB, Zucker ML. How to successfully influence laboratory test utilization. Clin Leadersh Manag Rev 2000;14:253–60. [6] The Patient Protection and Affordable Care Act 2010. [7] ABIM Foundation. ChoosingWisely.org 2013.
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[8] Kim JY, Dzik WH, Dighe AS, Lewandrowski KB. Utilization management in a large urban academic medical center: a 10-year experience. Am J Clin Pathol 2011;135:108–18. [9] Hindmarsh JT, Lyon AW. Strategies to promote rational clinical chemistry test utilization. Clin Biochem 1996;29:291–9. [10] Hernandez JS, Aderton J, Eidem L. The role of project managers who assist physician leaders at Mayo Clinic. Physician Exec 2011;37:62–5. [11] Warren JS. Laboratory test utilization program: structure and impact in a large academic medical center. Am J Clin Pathol 2013;139:289–97.
[12] Accreditation Council for Graduate Medical Education (ACGME) website 2013. [13] Lindenfeld J, Albert NM, Boehmer JP, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010;16:e1-194. [14] Wu AH. Serial testing of B-type natriuretic peptide and NTpro-BNP for monitoring therapy of heart failure: the role of biologic variation in the interpretation of results. Am Heart J 2006;152:828–34. [15] Iglesias Canadell N, Hyltoft Petersen P, Jensen E, Ricos C, Jorgensen PE. Reference change values and power functions. Clin Chem Lab Med 2004;42:415–22.
Contents lists available at ScienceDirect
Clinica Chimica Acta journal homepage: www.elsevier.com/locate/clinchim
Management structure: Establishing a laboratory utilization program and tools for utilization management Christine Snozek, Erin Kaleta, James S. Hernandez ⁎ Department of Laboratory Medicine and Pathology, Mayo Clinic Arizona, 13400 E Shea Boulevard, Scottsdale, AZ 85259, United States
a r t i c l e
i n f o
Article history: Received 10 August 2013 Accepted 20 September 2013 Available online 27 September 2013 Keywords: Utilization management Overuse, misuse and underuse of laboratory testing Effectiveness Efficiency
a b s t r a c t As laboratories are challenged to do more with fewer resources, the pathologist and laboratory director will play a greater role in improving the effectiveness of the laboratory, as well as addressing the overuse, misuse and underuse of laboratory testing. We describe the necessary characteristics for pathologists and laboratory directors to successfully lead utilization efforts, as well as key leadership tools and essential steps in creating a utilization management program. When we established a laboratory test utilization program de novo, it became clear how important the laboratory director was in guiding those initiatives by working with stakeholders outside of the laboratory, particularly clinicians, nurses and administrators. © 2013 Elsevier B.V. All rights reserved.
1. Rationale for establishing a utilization management program In the past laboratories were rewarded for performing more tests and charging for higher test volumes that resulted in greater revenue. This is typically called practicing to volume. Given recent economic concerns and debate over healthcare spending, laboratories are increasingly tasked with providing more services with the same or less revenue. This shift in focus from performing many tests to performing only the necessary tests has been termed practicing to value. Utilization programs are a growing part of shifting the culture of laboratory medicine from practicing to volume, to practicing to value. There are several key concepts related to any discussion of laboratory utilization. The United States Congressional Budget Office [1] defines the following: Overuse. Overuse occurs when a service is provided even though its risk of harm exceeds its likely benefit—that is, when it is not warranted on medical grounds. Underuse. At the same time that some services are overused, others do not get provided even though they would have been medically beneficial. Misuse. That term includes incorrect diagnoses as well as medical errors and other sources of avoidable complications. Utilization management. Utilization management (UM) represents a broad array of techniques designed to influence the consumption of health care services, usually with the objective of promoting cost containment [2].
⁎ Corresponding author. Tel.: +1 480 301 8606; fax: +1 480 301 8372. E-mail address: [email protected] (J.S. Hernandez). 0009-8981/$ – see front matter © 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.cca.2013.09.026
Efficiency and effectiveness. “In the management literature, efficiency is often associated with performing activities as well as possible or ‘doing things right’ whereas effectiveness is often equated with the proper selection of the activities or ‘doing the right things’” [3]. Essentially, the goal of a laboratory utilization program is to employ UM techniques to curb use of tests and laboratory products (e.g., blood products) that are over-utilized, increase use of tests and products that are under-utilized, and correct misuse of tests and products that are ordered incorrectly, at the wrong time, on the wrong patient, or at the wrong frequency. There are few guidelines in the literature on establishing successful laboratory test utilization programs other than descriptions of local or regional efforts in both community hospitals and academic medical centers, based primarily on perceived overuse (over-utilization) [4,5]. However, underuse and misuse are also important aspects to consider when evaluating test utilization. In the United States, hospitals are capitated for each Diagnosis Related Group (DRG). In addition, with the passage of the Patient Protection and Affordable Care Act (so-called “Obamacare”) [6], there are concerted efforts to have laboratory directors move the laboratories from being revenue centers to being cost centers. In essence, hospitals are reimbursed a set amount for the care of each patient according to the DRG, regardless of the volume or intensity of services provided. This is meant to force not only efficiency, but also effectiveness, by limiting reimbursement for healthcare expenditures. Lab tests for hospitalized inpatients are included in the DRG. Since this is a capitated patient population, it should be evident to the ordering providers that the more is spent on laboratory tests, the less is available for other services under the DRG system.
C. Snozek et al. / Clinica Chimica Acta 427 (2014) 118–122
However, in many areas, efforts to limit excessive testing for inpatients are relatively new and fairly basic. Evidence for this is provided by the lists of “Things Physicians and Patients Should Question” published as part of the American Board of Internal Medicine's Choosing Wisely initiative [7]. Of note, the Society of Hospital Medicine (SHM) published 5 recommendations, two of which pertain to laboratory utilization: “Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms of active coronary disease, heart failure or stroke”, and “Don't perform repetitive CBC and chemistry testing in the face of clinical and lab stability”. To most individuals in the laboratory these points are common sense, yet the SHM felt they warranted specific recommendations to hospital providers. Obviously, there is a gap between the laboratory and the clinical practice; effective utilization programs must overcome this breach to improve patient care. Fortunately, UM efforts are not completely foreign to labs. Blood banks have been monitoring blood product usage for decades. Lately, some institutions have created electronic approaches to verify whether patients meet specific criteria for various blood products, or to restrict higher cost blood products, requiring explicit approval from the laboratory director or transfusion medicine physician before dispensing [8]. Additionally, there are numerous examples published for monitoring send-out practices, particularly costly testing panels. Ordering of these panels can be streamlined into algorithm-based ordering practices, where reflexive testing is dependent on results from first tiered tests, in an effort to reduce ordering redundant or superfluous tests [9]. The challenge is to extend these initial efforts into more widespread UM of laboratory services. Utilization programs could exist in many areas, including tests performed in the clinical laboratory, products ordered from the blood bank, or molecular characterization of anatomic specimens. For simplicity, this article will refer to “laboratory test utilization” to encompass all aspects of testing or products typically managed by departments of laboratory medicine and pathology. Similarly, the terms pathologist and lab director will be used interchangeably to refer to the individual with scientific and clinical oversight of the test utilization program, regardless of degree or field of expertise. 2. Characteristics of the pathologist or lab director responsible for test utilization Laboratory testing UM is still in its infancy in the United States. However, there are some common elements in the utilization programs that have shown success. One of those elements is full engagement by a knowledgeable laboratory medical director [4]. Successfully steering a test utilization program requires a pathologist or lab director to demonstrate strong scientific, communication, and leadership skills. The individual should have sufficient knowledge of the specific areas included in the utilization program to make critical judgments — it may be difficult for an anatomic pathologist to weigh the necessity of an esoteric coagulation test, for example, or for a blood banker to assess proper utilization of a chemistry panel. The utilization program director must be a subject matter expert in the clinical laboratory, and capable of calling on experts in those areas in which he or she has less knowledge. To serve effectively, the pathologist or lab director must be respected by and have credibility with the laboratory, the clinical practice and the administration. Credibility is essential for the director's role in change management. UM programs always include an element of change; the most successful programs are those which move the culture of test ordering to one of optimizing clinical practice rather than simply limiting choices. The pathologist must have a good understanding that effective test utilization makes the local healthcare system stronger and improves patient care. He or she must also be able to communicate this concept clearly, and to work with physician leaders, residents, fellows, nursing, and administration to build the local infrastructure and methodology to optimize test utilization.
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Communication goes both directions: the pathologist or director must be willing to listen to the medical staff, who often feel that they have valid reasons for ordering a test the laboratory considers outdated or over-utilized. Listening does not imply that the providers' concerns will trump the laboratory's rationale for change. Instead, bidirectional communications are meant to establish a collegial atmosphere for discussing data and practice needs. These face to face discussions can also guide the pathologist in an important aspect of change management, namely knowing when and how far to push necessary changes. If providers are adamantly opposed to altering a particular practice, it may be wiser to first gain credibility by shifting focus to a less objectionable area of utilization, then revisiting the controversial topic at a later date. The director must work to establish trust. The pathologist must be able to use both intrinsic and extrinsic motivators to change provider behaviors regarding test utilization. Extrinsic motivators include the ability to use data from the local system to provide credible, practice-specific feedback to ordering providers. Deidentified, provider-specific utilization data enables each clinician to examine his or her own ordering patterns compared to peers and to self-adjust accordingly. Intrinsic motivators include providing persistent and persuasive guidance that gradually results in providers striving to order the right tests for the right indications at the right frequency. This guidance leads to a culture of regularly including test utilization considerations as part of optimal patient care. 3. Steps for establishing a test utilization program 3.1. Recognize the need Moving from the subjective desire to establish a utilization program to an objective reality requires data. The data acquired to support the need for UM will likely steer the format and targets of the program, and can often be used to gain clinical and administrative acceptance, as well as justify funding and resources. A laboratory can compare its institution's ordering patterns against other medical centers, through literature review, personal communication with colleagues, or benchmarking test utilization patterns with a multi-site data source such as the University HealthSystem Consortium. As an alternate or complement to this, a laboratory can compare against itself over time to assess trends in ordering patterns. Possible metrics range from the generic, e.g., number of tests per inpatient discharge or outpatient encounter, to the specific, e.g., charges for genetic tests sent to reference laboratories, volumes of particular tests suspected to be over-utilized, and number of tests per patient with a given diagnosis. 3.2. Prioritize initial goals Common goals for UM include cutting laboratory costs, improving laboratory efficiency, increasing payer reimbursement, refining provider ordering patterns, or reducing unnecessary testing. These objectives are often inter-related: for example, eliminating orders for an outdated test can save the lab reagent costs and technologist time. However, the relative importance of each goal will likely not be the same for different members of the project team. The discussion of priorities is important for the formation of the test utilization project; ultimately, it may be the responsibility of the pathologist or lab director to define the primary purposes of the utilization program. It is important to recognize that the goals of a UM program will likely evolve over the life of the project based on factors such as experience and provider feedback, but the initial objectives should be clearly stated as they will steer the program's structure and early targets. 3.3. Choose framework The structure of a laboratory utilization program can vary around a large number of parameters. For example: should it evaluate ordering
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practices for inpatients, outpatients, or both? A limited number of practice locations, or all practices within an institution including remote primary care sites, urgent care clinics, etc.? In-house performed tests, send-out tests, or both? Laboratory tests, blood products, pathology services, or all of these? These decisions must be made while keeping available resources in mind, particularly the time and funding of laboratory directors, lab staff, and information technology (IT) as well as the cooperation of administrative and clinical colleagues. Larger projects can be facilitated by inclusion of additional personnel such as project managers, individuals with coding and billing expertise, and especially residents or fellows. 3.4. Understand ordering system To effectively address test utilization, those responsible for evaluating ordering practices must first understand how providers order tests. Key questions include: are orders placed electronically or manually? Are they chosen from pre-defined order sets, i.e., groups of tests organized by clinical practice or indication, or individually from the full test menu or a provider's “favorites” list? Can others on the care team (nursing, residents, or attending physicians) see what orders have already been placed, or are pending/future orders difficult to find in the ordering system? This knowledge may steer project targets and interventions. For example, removing tests from pre-defined order sets may rapidly discourage providers from requesting those tests unless they are specifically required for a given patient. 3.5. Outline plan Utilization programs can be very resource-intensive, particularly in terms of IT. The availability of IT and lab resources, along with the project goals and framework, will drive the subsequent steps of initiating a test utilization program. With sufficient IT capacity, it is possible to pull a large amount of data from the laboratory information system or electronic medical record to create a database for numerous utilization projects. If resources are scarce, it might be more practical to acquire data for a limited number of individual projects, starting with lowhanging fruit such as high-volume tests with poor reimbursement rates. Ultimately, goals for intervention following test utilization may be IT resource dependent as well; for example, changing accessibility of particular tests in order sets, or initiating pop-up messages regarding ordering patterns. It is therefore key to understand the availability of local resources when outlining a UM plan. 3.6. Initiate pilot studies Regardless of resource availability, it is advisable to start with a small number of relatively simple projects. Pilot projects can be quite useful for refining data acquisition parameters, identifying unanticipated requirements or roadblocks, evaluating what clinical input is required, and creating mechanisms for communicating findings to the laboratory, administration, or clinical practice. If resources are limited, pilot projects might also be helpful in gaining acceptance of and funding for additional, larger utilization efforts. Studies should include planning for follow-up. For example, once providers are educated on proper utilization of a specific test, re-evaluating the data shortly after the education and then 6–12 months later can indicate whether the change was adopted long-term by clinicians, or if they reverted to the previous practice. 3.7. Evaluate efficacy As pilot studies are ongoing or nearing completion, the medical director should take time to review them, with an eye toward improving the process for future studies. Were the chosen projects large enough to provide noticeable benefit, but small enough to handle with available resources? How effective was the data pull strategy — was all necessary
information accessible, without much extraneous material? Were the correct clinical partners involved, and at an appropriate time? Regardless of whether a given project was successful or not, it is often possible to find aspects that could be done better in future efforts, leading to an iterative improvement of the UM program as a whole. 4. Tools for test utilization programs Key to the success of any laboratory utilization program is lab test formularies, test algorithms, and the use of reliable data generated from the local informatics of the system. Detailed discussion of the power of informatics in improving test utilization is provided later in this special edition, as are focused articles on lab test formularies, test algorithms, and other specific tools for utilization programs. Although the pathologist should provide medical and scientific oversight of these resources in designing a UM program and monitoring its implementation and effectiveness, these tools will not be covered extensively here. Rather, this section will focus on the communication and management tools pathologists and other laboratory leaders will require to direct the culture of laboratory testing toward practicing to value. Perhaps the most important role of the laboratory director in UM is as a liaison to providers. Successful culture change starts with communication between the laboratory – often routed primarily through the lab director – and the clinical practice. A utilization program depends on the willing participation of the formal and informal leaders of the clinical practice, especially those who order many tests. This includes division and department chairs, residency and fellowship program directors, and education staff. It is nearly impossible to effect significant change if the clinical practice is not integrated but rather is comprised of a collection of individual practices. Several UM tools can be quite useful for shifting test utilization culture within the clinical practice, including readily available access to peer-reviewed literature or expert opinion on a topic; short educational learning points; and provider-specific scorecards. For larger UM projects, it is helpful to include project managers, since they are experts in change management tools, tracking changes, and ensuring that projects are meeting goals on time and on budget [10]. As the UM program matures, relatively strong measures may be implemented, including limiting send-out reference tests to a select group of CLIAcertified laboratories and establishing a lab test formulary or test review committee [11]. An understanding of certain human factors is key to effective leadership of a UM program, including knowledge of personality types, learning styles, and generational differences. Some of the tools needed for UM are novel for many pathologists and scientists, and include negotiation. Consideration could be given to developing a podcast or video that shows vignettes about how a pathologist or scientist “negotiates” with a clinician who insists that a test is needed when the literature-supported evidence indicates otherwise. Since much of the UM efforts are iterative, it is important to celebrate achievements and provide feedback about progression of utilization initiatives to encourage forward momentum. For example, presentations, abstracts, white papers and peer-reviewed publications can be used for both internal practice and for external distribution. The laboratory can create a website that categorizes current efforts and completed projects so that all practices can continuously learn from others' accomplishments. Sharing best practices allows others to learn about successes in UM since this is a new endeavor for many labs. In particular, successes in creating rational use programs for expensive tests such as genetic and genomic send-outs are especially instructive. 5. Role of the pathologist or lab director in the test utilization program The lab director should be intimately involved in all aspects of establishing and maintaining a utilization program. In addition to
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providing scientific guidance for the steps outlined above, the lab director, whether a pathologist or a laboratory scientist, has several other leadership roles. He or she is responsible for establishing deadlines to eliminate tests that have strong published evidence against their use. The director should support projects in all areas to optimize the process of improving test utilization; successes in Transfusion Medicine in improving blood product utilization in many local healthcare systems can serve as a template. It is important to note that support entails ensuring all projects have sufficient resources for data mining and other key activities. If individual utilization efforts stall, the director or pathologist should investigate the reasons why, and consider using project management expertise to bring these projects to completion. As a link between the laboratory and the clinical practice, the pathologist is integral in identifying physician partners to serve as formal and informal leaders in test utilization efforts. Well-respected providers who are proponents for improving utilization can facilitate communication from the laboratory to their peers in the practice, and are critical in gaining acceptance from the clinical community as a whole. Cooperation with the clinical practice can also enhance educational opportunities, particularly for residents and fellows. The Accreditation Council for Graduate Medical Education (ACGME) requires residents and physician fellows to examine their practice patterns and to self-adjust based on what they learn. Many test utilization projects fall into the category of Practice Based Learning and Improvement, one of the key ACGME objectives for self-assessment to meet certification requirements [12]. The pathologist must establish multidirectional communication among the laboratory and clinical leaders, administration, and nursing. The goal is to facilitate a team approach that includes subject matter experts in multiple disciplines, and clinical colleagues who are interested in changing ordering practices. The medical director should consider engaging colleagues in laboratory medicine and pathology that have been successful in building their own test utilization programs and improving collaboration with clinical colleagues. It is important to emphasize the process of how to work with providers to change behavior, rather than merely focusing on the details of what needs to be changed. Systematic improvement of ordering processes as well as collegial guidance are necessary for rapidly effecting the desired ordering patterns, i.e., making it easier for clinicians to order the right test, for the right patient, for the right indication, at the right frequency. 6. An example of a laboratory UM program Concern regarding the perceived over-utilization of some tests and an audit of our testing patterns resulted in a project in 2011 to optimize ordering habits to minimize unnecessary repeat laboratory tests. Our test utilization program was established with a focus on decreasing the number of high volume, high cost tests while maintaining appropriate patient care. There was a deliberate attempt to employ evidencebased medicine to move from practicing to volume to practicing to value. Test utilization studies in our practice were initiated to address concerns for over-utilization. Tests that were frequently being underreimbursed under the DRG cost structure were identified to recognize high impact areas for test-utilization studies. Analysis of our internal financial data showed that some tests consistently had payment denied due to insufficient justification for ordering the tests or for performing the tests too frequently, including complete blood counts, magnesium, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). In cooperation with nursing informatics and financial personnel, a database was created to capture utilization information from the electronic medical record, including admission dates, location and length of stay, reason for admission, tests and blood products ordered, ordering physician, and laboratory test results. A complicating factor for UM in our system is the availability of recurring order sets, where a single order is placed that allows for repeated testing at predefined time intervals. The database includes the date an order was placed and when the test was
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resulted, allowing for identification of such recurring orders. This database was originally populated with one year of data, and is added to quarterly. Given predetermined criteria, the database can be filtered and queried, depending on the needs of the test utilization project. As an example, this database was utilized for investigating ordering patterns for NT-proBNP. Studies have demonstrated that the utility of NT-proBNP lies with identifying patients with congestive heart failure (CHF) and aiding in staging of patients with confirmed CHF. There is limited use in serial monitoring of NT-proBNP for trending of disease progression or improvement due to large intra-individual variability of this marker. The guidelines for CHF [13] recommend a single measurement of NT-proBNP per hospital stay. The utilization database was queried to determine the frequency of NT-proBNP orders. In 2011, of 2630 NT-proBNP tests ordered, 62% were repeat orders within one hospital stay, 40% of which were placed via recurring order sets. Literature guidelines [14,15] regarding the reference change value needed to show clinically significant changes in NT-proBNP were used to define whether serial testing was medically indicated. Of the over 1600 repeat orders in 2011, less than half showed a clinically significant change compared to the first measurement. Lab orders placed via recurring order sets were less likely to exceed the reference change value than were orders placed independently during a single stay. These findings were returned to the chair of the division that ordered the majority of NT-proBNP tests; the chair subsequently shared the deidentified ordering patterns with the ordering providers. This provided evidence-based information about ordering practices within their division, allowed for education about test utilization, and raised awareness of over-use of that particular laboratory test. A robust ordering database offers a post-education assessment tool, where similar studies can be performed after notifying providers of their activity on a periodic basis to potentially curb over-utilization of key tests. This study provided the model for future UM studies within our institution which can be used in a variety of situations across the testing menu. 7. Conclusion Simply put, UM efforts cannot succeed without a knowledgeable and engaged pathologist or laboratory scientist director with strong leadership and communication skills, as well as the ability to manage change and provide motivation to a large collaborative team across the medical practice. Beyond simply imparting medical and scientific expertise, the director must serve as an effective liaison to providers and administration, to steer the cultural shift toward including utilization considerations in daily practice. The goal of UM is to use electronic resources to monitor usage and necessity of testing and laboratory resources. A successful method for developing these projects uses a multidisciplinary approach that engages a combination of laboratory scientists, physicians and system analysts to map out guidelines that are optimal for patient care, efficiency of clinical service and practicing to maximize value of care, as opposed to volume.
References [1] United States Congressional Budget Office. The overuse, misuse, and underuse of health care 2012. [2] Wickizer TM, Lessler D. Utilization management: issues, effects, and future prospects. Annu Rev Public Health 2002;23:233–54. [3] Drucker PF. An introductory view of management. New York: Harper College Press; 1977. [4] Hernandez JS, Plapp FV, Essmyer CE, Forsman RW. Successful models for shaping test utilization patterns in academic and community hospital settings. Clin Leadersh Manag Rev 2009;23:E5. [5] Plapp FV, Essmyer CE, Byrd AB, Zucker ML. How to successfully influence laboratory test utilization. Clin Leadersh Manag Rev 2000;14:253–60. [6] The Patient Protection and Affordable Care Act 2010. [7] ABIM Foundation. ChoosingWisely.org 2013.
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[8] Kim JY, Dzik WH, Dighe AS, Lewandrowski KB. Utilization management in a large urban academic medical center: a 10-year experience. Am J Clin Pathol 2011;135:108–18. [9] Hindmarsh JT, Lyon AW. Strategies to promote rational clinical chemistry test utilization. Clin Biochem 1996;29:291–9. [10] Hernandez JS, Aderton J, Eidem L. The role of project managers who assist physician leaders at Mayo Clinic. Physician Exec 2011;37:62–5. [11] Warren JS. Laboratory test utilization program: structure and impact in a large academic medical center. Am J Clin Pathol 2013;139:289–97.
[12] Accreditation Council for Graduate Medical Education (ACGME) website 2013. [13] Lindenfeld J, Albert NM, Boehmer JP, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010;16:e1-194. [14] Wu AH. Serial testing of B-type natriuretic peptide and NTpro-BNP for monitoring therapy of heart failure: the role of biologic variation in the interpretation of results. Am Heart J 2006;152:828–34. [15] Iglesias Canadell N, Hyltoft Petersen P, Jensen E, Ricos C, Jorgensen PE. Reference change values and power functions. Clin Chem Lab Med 2004;42:415–22.