Viewing information management as an opportunity for

Transcription

1 Pathologists as Stewards of Laboratory Information Walter H. Henricks, MD; Myra L. Wilkerson, MD; William J. Castellani, MD; Mark S. Whitsitt, PhD; John H. Sinard, MD, PhD Just as electronic health records are transforming the practice of medicine and health care information management, practicing in the era of the electronic health record offers opportunities, if not imperatives, for pathologists to take on new and transformative professional and leadership roles for the organizations they serve. Experience indicates that clinicians will perceive pathologists and laboratories as responsible for all aspects of laboratory testing and information management, including order entry and results reporting, even though such functions may fall beyond the control of the laboratory. As described and expanded upon in the previous 4 articles of this series, the use of electronic health records dictates changes in how clinicians interact with laboratory information. In this environment, pathologists are uniquely positioned to act as the stewards for laboratory information in electronic health records and throughout health care organizations. (Arch Pathol Lab Med. 2015;139: ; doi: / arpa so) Viewing information management as an opportunity for pathologists is not new. As early as 1987, Korpman 1 described a role for the pathologist as medical information specialist within health care organizations. He argued that the pathologist is uniquely positioned for that role, particularly in a hospital setting. Friedman, 2 often credited with the first usage and dissemination of the term pathology informatics, argued that this discipline within the specialty of pathology already had a defined role within pathology Accepted for publication July 31, From the Center for Pathology Informatics, Cleveland Clinic Foundation, Cleveland, Ohio (Dr Henricks); the Division of Laboratory Medicine, Geisinger Medical Laboratories, Danville, Pennsylvania (Dr Wilkerson); the Department of Pathology and Laboratory Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania (Dr Castellani); the Diagnostic Intelligence and Health Information Technology Committee, College of American Pathologists, Northfield, Illinois (Dr Whitsitt); and the Informatics Program, Department of Pathology, Yale University School of Medicine, New Haven, Connecticut (Dr Sinard). The authors have no relevant financial interest in the products or companies described in this article. This work was commissioned by the Diagnostic Intelligence and Health Information Technology Committee of the College of American Pathologists (CAP). The content of this article is the product of its authors and should not be construed as a policy statement by the CAP. Reprints: Walter H. Henricks, MD, Center for Pathology Informatics, Cleveland Clinic Foundation, L21 Pathology & Laboratory Medicine Institute, 9500 Euclid Ave, Cleveland, OH ( henricw@ccf.org). departments. More recently, Sinard and Morrow 3 described electronic information management as crucial to the future of the specialty of pathology. Finally, in a 2005 survey, 4 pathologists and pathology administrators ranked informatics and related skills as among the most valuable skills for new pathologists entering pathology practice. The emerging role for the pathologist as the steward for patient laboratory information management in the electronic health record (EHR) stems from pathologists core expertise and experience. Pathologists have proficiency in electronic data management and have used clinical information systems as an integral component of laboratory operations for decades. 5 7 Operational efficiency of the laboratory and the perception of the quality of the laboratory s work have long depended on effective management of electronic data flow Because such matters are integral to laboratory operations, pathologists are expert in data content and format requirements for laboratory result reporting and test ordering. Pathologists can understand and anticipate nuances and complexities of laboratory information management that affect patient care and safety, and they have an appreciation for how to display laboratory information to trigger appropriate clinical action. Furthermore, the communication of patients laboratory information, including qualitative, quantitative, and descriptive, has always been the domain of the laboratory and the pathologist. This domain expertise is recognized by the US Department of Health and Human Services, and the Centers for Medicare and Medicaid Services because the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 11 place responsibility for key information management functions squarely on the laboratory director. 12 The CLIAspecified responsibilities related to laboratory information management include required data elements for test requests (ie, orders), required data elements for test reports, verification of accurate and timely transmission of laboratory results from the point of data entry to the final report destination, and appropriate communication and identification of corrected laboratory reports. 13,14 The requirements apply to electronic versions of the aforementioned documents and processes, and, in an EHR setting, laboratory test requests originate in the EHR, and laboratory test reports are transmitted to and reside in the EHR. Admittedly, pathologists face barriers to developing fully into the role of steward of laboratory information beyond the laboratory. The EHR is often beyond the administrative control of the laboratory, and crucial test order entry and result reporting functions typically reside in the EHR under control of an institutional information technology (IT) organization. 15 Pathologists typically already have a day job, and devoting time to laboratory information system (LIS) and EHR- 332 Arch Pathol Lab Med Vol 139, March 2015 Stewardship Roles Henricks et al

2 Table 1. Success Strategies for Pathologists to Act as Stewards of Laboratory Information Handling in the Electronic Health Record (EHR) Recognize and accept that laboratory information management in the EHR is now part of laboratory operations and patient care Participate in EHR selection and implementation processes Get involved in formal EHR-related processes and groups in the institution Build key relationships with those responsible for EHR matters in the institution Cultivate EHR-laboratory expertise among laboratory technical staff Document and communicate laboratory s contributions to ongoing EHR efforts, projects, and troubleshooting Leverage experience working with laboratory information system vendors Contribute to clinical decision support and test use initiatives related issues would represent an incremental time commitment and effort on their part. Coupled to this is that direct financial reimbursement (eg, fee codes) attributable to such activities is currently lacking. Additionally, some pathologists may lack, or at least lack confidence in, their knowledge of informatics, and involvement in EHR-related issues may be outside of their comfort zone. STRATEGIES FOR PATHOLOGISTS TO SUCCEED AS STEWARDS OF LABORATORY INFORMATION HANDLING IN THE EHR Several strategies may be used by pathologists when they move toward the role of primary steward of laboratory information. Many of these strategies are discussed below and are summarized in Table 1. Recognize and Accept That Laboratory Information Management in the EHR Is Now Part of Laboratory Operations and Patient Care The EHR has taken on a new and crucial role in laboratory workflow and information processing. The EHR defines the preanalytic (order entry) and postanalytic (result reporting) information channels that are critical to the mission of laboratory operations and patient care. Before widespread EHR adoption, the laboratory, under the guidance and responsibility of the laboratory director, influenced or controlled those data management processes through laboratory-developed test-requisition forms, report formats, and related practices. The analogous activity in the EHR era is for proactive involvement on the part of laboratory director and/ or designees in EHR laboratory information management issues and challenges. Participation and leadership in those activities is as fundamental a laboratory administrative function as other established activities, such as quality management, continuous improvement, regulatory compliance, competency assessment, among others. An example of an EHR-related activity that a laboratory could incorporate into a quality management plan might be performance metrics to monitor the effect of EHR-based computerized provider order entry (CPOE) on laboratory services. 16 Participate in EHR Selection and Implementation Processes Purchase and implementation of a new EHR in a health care institution represent tremendous opportunities for Table 2. Key Roles for Pathologists and Laboratories in an Electronic Health Record (EHR) Implementation Ensure that order entry screens and processes are configured appropriately for laboratory test ordering Provide laboratory perspective and requirements for the presentation and organization of laboratory result information (eg, cumulative result display screens) Validate and thoroughly test the accuracy and timeliness of data exchange through LIS-EHR interfaces Establish processes for coordinating and communicating new laboratory test definitions and changes to existing tests in the EHR Abbreviation: LIS, laboratory information system. pathologists and laboratories to demonstrate value and to foster influence within the organization. Having an important and visible role in the success of a strategic project, such as that, offers both tangible and intangible benefits to pathologists. Tangibly, successful participation can demonstrate pathology s commitment to supporting their institution and their domain expertise, potentially positioning pathology for further success in future clinical informatics efforts, such as clinical decision support and guideline development. Less tangibly, in health care organizations, as in other types of organizations, political influence accrues to those subunits of an organization that are best able to solve the organization s strategic problems. 2 The ability to work collaboratively and effectively across organizational boundaries can only enhance that influence. Selection and implementation are distinct phases of EHR projects with multiple opportunities and requirements for pathology s expertise and input. The EHR selection committees, of which there may be several and addressing different aspects of the project (eg, clinical, financial, infrastructure, among others) are venues in which pathologists and/or their designees can be at the table with key decision-making leadership, whether it be at the laboratory director level or at the analyst level. Lack of pathology involvement may result in neglect of issues, with adverse consequences for patients, the laboratory, and the institution. Following EHR evaluation and selection, pathologists and laboratories can be integral to successful implementation of the new EHR. Implementation work teams require laboratory representation and active input to ensure that EHR data definitions and system configurations adequately support functions related to laboratory test order entry and results display. Specific examples of crucial roles for pathologists and their designees in an EHR implementation are summarized in Table 2. Get Involved in Formal EHR-Related Processes and Groups at the Enterprise Level Formal EHR and IT governance committees or groups are important opportunities for pathologists to increase their visibility and influence on such matters at the enterprise level. Such committees or teams may determine organizational information-management strategy, prioritize EHRrelated projects and system enhancements, oversee and/or implement information-system changes, provide a venue for EHR-related concerns that affect patient care, or assess EHR-related organizational risks. Examples of these groups include EHR steering committees, physician advisory groups or task forces, medical records committees, or similar Arch Pathol Lab Med Vol 139, March 2015 Stewardship Roles Henricks et al 333

3 organizations. These are important venues for pathologists to be at the table. In such settings, pathologists can raise organizational awareness of potential concerns in EHR laboratory information management and can generally advocate for laboratory-specific concerns. In addition, there may be EHR-related administrative or technical committees (eg, risk management, patient safety) that do not necessarily require pathologist involvement, but for which, it may be in the best interest of the laboratory director to ensure laboratory representation. Build Key Relationships With Those Responsible for EHR Matters at the Enterprise Level Cultivating key relationships at various levels of the organization is an important way for pathologists to empower themselves in the EHR era. Establishing those contacts requires going outside of the laboratory. Pathologists can influence EHR laboratory information management decisions at a high level by building relationships with institutional EHR/IT and leadership. In many organizations, the chief information officer determines the overall IT strategy for the institution and is responsible for the implementation and support of the EHR system. Increasingly, health care institutions are designating a physician for the position of chief medical information officer. 17 The chief medical information officer can be an excellent potential collaborator, particularly as a physician peer. Pathologists can build new, or leverage existing, peer relationships with clinicians who are interested or influential in EHR issues. Examples include chief of staff, safety officer, quality officer, and other clinicians who are persuasive within the institution. These individuals are potentially valuable avenues for raising awareness of how EHR laboratory issues can affect patient care, quality, and safety, and, as such, they may be strong allies when communicating EHR-related concerns to institutional leadership. Other peer relationships that a pathologist or laboratory director can foster are between laboratory staff and the system analysts responsible for EHR support. A good working partnership with the IT team that manages EHR definitions and configurations directly affecting EHR user experience may greatly facilitate addressing laboratory needs and requests in the EHR. These teams also will work with the laboratory for testing LIS-EHR interfaces and other changes relevant to the laboratory. A risk to the laboratory by not engaging EHR support staff is leaving laboratoryrelated EHR design or configuration decisions in the hands of people who may not understand the clinical or laboratory implications of such decisions, which can have negative consequences for the laboratory testing cycle. 16,18 24 Enlisting the assistance of the institutional compliance office may also be helpful in resolving EHR-laboratory problems. Laboratory regulatory and accreditation requirements may drive EHR configuration decisions, which may be unpopular with EHR end users. Examples include prompts for required clinical data in test orders, billing requirements (eg, International Classification of Diseases codes), and report content and format issues (eg, CLIArequired data elements in the report; information on the performing laboratory). Support from the compliance office may help the laboratory to effect configuration changes in the EHR that are necessary to meet regulatory requirements. Cultivate EHR-Laboratory Expertise Among Laboratory Technical Staff The importance of and risks associated with EHR laboratory information management implies a need to allocate laboratory resources to be involved in EHR-related activities, and laboratories already typically have one or more technical staff members who have responsibility for and expertise with the LIS. 7,25 Those members may be medical technologists, laboratory supervisors, or managers with experience and/or training in LISs. The knowledge of those individuals often spans laboratory testing and workflow along with LISs, their databases, and their associated interfaces. Pathologists can take advantage of the experience and domain expertise of those individuals to represent the laboratory in EHR issues and to interact with EHR support personnel. Among the skill sets that carry over well from LIS support to EHR-related laboratory activities are (1) defining tests in system data tables, (2) implementing and supporting electronic interfaces between systems, (3) testing and validating information systems, and (4) developing and adhering to change-control procedures. Professional development opportunities exist for laboratory technical staff to develop and to enhance their expertise in laboratory information management (and in clinical informatics generally). For example, the American Society for Clinical Pathology offers a certification program for medical technologists in Qualification in Laboratory Informatics, in recognition of the relevance of this expertise to laboratories. 26 The American Association for Clinical Chemistry offers an online certification program in Basic Principles and Architecture of Laboratory Information Systems. 27 Document and Communicate Laboratory s Contributions to Ongoing EHR Projects and Troubleshooting Although challenging, problems that arise in the laboratory related to the EHR present opportunities for pathologists and laboratories to demonstrate to their institutions the value of having laboratory domain experts involved in EHR troubleshooting and problem resolution. Over time, such contributions can build institution-wide credibility for the need for laboratory involvement in EHR matters. Effective documentation and active communication of pathologist and laboratory staff involvement with EHR management challenges may also help establish the justification for new laboratory resources. A straightforward example would be to create a process for capturing/saving computer screen views of problems or errors in laboratory result displays in the EHR at the time of detection and after laboratory intervention or correction. Such communication, however, requires care to emphasize collaboration and avoid focusing on placing blame for failed efforts. Colleagues in IT functions across the organization will have significant influence on the justifications for additional laboratory informatics staff and equipment, and an effective relationship between the laboratory and IT department is useful. Leverage Experience Working With LIS Vendors Managing relationships with EHR and LIS vendors may be an important element of a pathologist s role in the EHR era. Because LISs have been a core part of laboratories for decades, pathologists experience working with LIS vendors 28,29 can be valuable in dealing with them or, at least, in understanding the dynamics of a vendor relationship. Pathologists can anticipate that LIS and EHR configurations, 334 Arch Pathol Lab Med Vol 139, March 2015 Stewardship Roles Henricks et al

4 Table 3. Potential Uses of Clinical Decision Support in Computerized Provider Order Entry to Improve Test Use Alert to, or prevention of, repetitive test orders for a given test within a defined period Display of previous result value and date/time for same test being ordered Display of result value and date/time for test results related to test being ordered Prevention of reorder for once-in-a-lifetime tests (eg, germline genetics) Recommendation of a more-appropriate alternative test to the test being ordered Permission for only certain physicians (eg, specialists) to order certain types of tests Constraints on expensive send-out testing data definitions, and settings will be interdependent in this environment. Problem resolution or system enhancements may require changes to either or both of the LIS and the EHR. Although typically the institutional IT/EHR support team will interact directly with the EHR vendor, pathologists who are familiar with vendor interactions may more effectively articulate laboratory needs to the EHR vendor support team. Pathologists may find themselves in a position to communicate directly with EHR vendors about enhancements for laboratory information handling, particularly if the EHR vendor is one that appreciates the importance and complexities of laboratory information management issues. Contribute to Clinical Decision Support and Test Use Initiatives Clinical decision support (CDS) refers to computerized tools that provide information and/or that insert alerts that are context specific and are provided at appropriate times to enhance decision making in the clinical workflow. 30 Moreover, CDS is an integral part of EHRs, 31 and knowledge of the CDS is a requirement for health care providers to achieve meaningful use of EHRs. 32 The CDS tools include real-time alerts at the time of order entry (CPOE), reminders, clinical guidelines, and interpretive information. Health care institutions typically configure the criteria, rationale, and/or logic that determine the conditions and circumstances for CDS use in the settings of the EHR system. Clinical decision-support modules are excellent means for pathologists to influence laboratory test-ordering practices and to foster appropriate test use. The use of rules and alerts in CPOE for laboratory test ordering affords pathologists an unprecedented opportunity to intervene in real time at the point of order entry. Pathologists can recommend test use criteria and parameters and can work with clinical colleagues and EHR staff to implement alerts that fire or pop up during the order entry process under defined conditions. For example, a decision support rule may alert the user if the test he or she is ordering has been ordered in the past 24 hours and that the test is typically not indicated more than once a day. The rule may also prevent the user from placing the order under those conditions. Applications of CDS and CPOE for clinical laboratory testing have been recently reviewed in depth. 33 Examples of implementation of laboratory testing in CDS for CPOE include improved compliance with plasma-transfusion guidelines, 34 reduced inappropriate repeat testing for B-type natriuretic peptide in patients with heart failure, 35 improved effectiveness of coagulation testing, 36 optimized cardiac marker use, 37 and reduced scheduling of repeat laboratory testing in pediatric patients in intensive care units. 38 Potential uses of CDS in CPOE to improve test use are listed in Table 3. The opportunity that CDS in CPOE offers to intervene at the time of order entry may also encourage a proliferation of rules and alerts that can be counterproductive and even burdensome to providers in the clinical setting. Alert fatigue, in which clinicians are bombarded with alerts and pop-up messages during use of an EHR, can lead clinicians to ignore, disregard, and/or circumvent decision-support prompts. 39 Pathologists involved in determining laboratoryrelated CDS alerts should bear in mind this phenomenon and tailor alerts, and circumstances in which they fire, in a manner that mitigates alert fatigue. To address test use, a recent trend is development of formal test-use committees or laboratory formulary committees. Although there are various models, 40,41 generally those groups define prohibitions, restrictions, or other conditions for ordering particular laboratory tests. Tests most commonly targeted are high-cost tests and send-out tests. Pathologists, by virtue of their domain expertise, their responsibility for laboratory testing, and their proficiency in working with data, are well positioned for a leading role in those oversight bodies. 42 It is a natural extension of pathologists core expertise to provide evidence-based rationales for test-formulary decisions and for configuration of corresponding decision-support rules in the EHR. Such a role may provide even greater opportunity with the emergence of coordinated care models, value-based care purchasing, and accountable care organizations. 43 PREPARING FOR THE ROLE OF LABORATORY INFORMATION STEWARD Possessing at least a fundamental knowledge of informatics will be beneficial, if not essential, for pathologists to meet the challenges of practicing successfully in the EHR era and to fulfill the role as steward of laboratory information in the EHR era. A workgroup from the Association for Pathology Informatics previously set forth comprehensive learning objectives 44 for a foundation in informatics training during pathology residency, arguing that information management is as essential to being a pathologist as are diagnostic and laboratory management skills. This does not imply that all pathologists must become informatics specialists, but rather, that a baseline fluency and awareness of information management topics are desirable because information management is a core part of the specialty of pathology. Such need is heightened with the widespread adoption of EHRs. Furthermore, the preparation and skill sets needed to pursue the approaches described in this article extend beyond technical topics and include organizational and process-management skills. The latter 2 skills, along with a willingness to address the interpersonal and communication aspects of informatics issues, are more important than IT technical proficiency in many situations. SUMMARY AND CONCLUSIONS The Oxford Dictionary defines steward as a person whose responsibility it is to take care of something. 45 An EHR transforms the manner in which clinicians interact with Arch Pathol Lab Med Vol 139, March 2015 Stewardship Roles Henricks et al 335

5 laboratory data and the ways in which the laboratory information flows within health care organizations. In this context, pathologists as stewards take a share of the responsibility for the appropriate handling of patients laboratory information in the EHR and other places that information may flow electronically within and across organizations. Pathologists are well positioned to act as guardians of the integrity of laboratory information in EHR-related processes. Pathology and laboratory data are crucial to taking care of patients in all (or nearly all) medical specialties and throughout the continuum of care. Clinical laboratories and the specialty of pathology have decades worth of experience relying on electronic data management and LISs. Functioning as steward of laboratory information in the EHR era requires pathologists not only to address ways in which deployment of EHRs affects their laboratories but also to engage in enterprise-level activities outside of the laboratory. Within the laboratory, success strategies include accepting EHR-related issues as an integral part of laboratory management and fostering EHR involvement and expertise among laboratory technical staff. In the enterprise, pathologists can participate in EHR-related committees or teams and build relationships with key individuals who have influence in EHR activities and oversight. Ultimately, it is the thorough understanding of the laboratory information domain and how EHR and organization-wide processes affect it that are the basis for the unique perspectives, contributions, and value that pathologists offer as stewards of patients laboratory information in the EHR era. References 1. Korpman RA. Using the computer to optimize human performance in health care delivery: the pathologist as medical information specialist. Arch Pathol Lab Med. 1987;111(7): Friedman BA. Informatics as a separate section within a department of pathology. Am J Clin Pathol. 1990;94(4)(suppl 1):S2 S6. 3. 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