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Pathology Informatics Essentials for Residents: A Flexible Informatics Curriculum Linked to Accreditation Council for Graduate Medical Education Milestones.

Informatics has never been more relevant to the specialty and practice of pathology. Generating and managing information derived from processing, analysis, and interpretation of patient specimens form the core of the mission of pathology to provide information that is crucial to patient care. Over the years, informatics has had multiple definitions. Medical informatics is the science of how to use data, information, and knowledge to improve human health and delivery of health care services. (1) The College of American Pathologists defines clinical informatics as the application of information management in health care to promote safe, efficient, effective, personalized, and responsive care. (2) The domain of pathology informatics includes clinical informatics and extends to involve information- and technologyintensive elements that are unique to pathology. (3,4) Pathology informatics activities have application at the individual, institutional, community, and population levels. (2)

Experience and observation confirm that informatics training in pathology residency programs is often absent, or when offered, inconsistent from program to program and frequently lacking in depth, breadth, and structure, particularly in comparison to more traditional areas of pathology training. (5,6) To address the need for informatics training in pathology residency programs, 3 organizations--the Association of Pathology Chairs (APC), the Association for Pathology Informatics (API), and the College of American Pathologists (CAP)--convened a joint work group of pathology informatics experts and authorities in pathology graduate medical education (GME). This work group, led by a core team of informatics and education leaders from the 3 organizations, developed and released the Pathology Informatics Essentials for Residents (PIER), a novel and flexible curriculum for educating pathology residents in informatics. PIER offers both a curriculum and instructional process for incorporating informatics training into pathology residency programs. This article describes the rationale for PIER, its development process, the PIER curriculum and Resource Toolkit, and PIER's companion change management strategy.

RATIONALE

The recognition of the importance of informatics to the specialty and practice of pathology has surged in recent years. (7) Computers, laboratory information systems, and data management have been familiar to pathologists for decades because they are integral to pathology as a specialty. (8) Numerous factors are driving the prominence of informatics in pathology practice, including rapid information technology changes, increased electronic health record adoption, novel laboratory methods such as molecular tests, prioritized patient safety initiatives to minimize misidentification errors, increased health information technology-related regulations, and changing business needs (Table 1). The increasing role and recognition of informatics in contemporary pathology practice presents a strong argument that acquisition of a basic knowledge of informatics should be part of the preparation of future pathologists.

In line with the observations above, expectations for pathology residency programs to train their residents in informatics are increasing. Training residents in informatics has been a daunting task for most programs in the United States because of the absence of a standardized curriculum, the limited number of faculty with informatics expertise, numerous competing subject matter priorities and practical time constraints, and the rapid pace of change to the content due to both technologic advances and evolving regulatory needs. These challenges notwithstanding, the pathology community recognizes the mandate for appropriate exposure and training in informatics to enable the advancement and transformation of the practice of pathology. (7,9,10)

APPROACH

The CAP, APC, and API formed a collaborative partnership in 2013 to address the need to educate pathology residents about informatics. The 3 organizations jointly convened a work group of 20 pathologists with expertise in informatics and/or in GME to help develop the PIER curriculum for residents. The intent was to design a program that could be implemented in essentially any pathology residency program, whether or not that program had a local pathologist informaticist on the faculty. The work group researched and developed 38 peer-reviewed outcome statements identifying the knowledge and skills that all residents should have in pathology informatics to practice pathology upon completion of their residency program. The group also reviewed core content for the new certifying Board Examination in Clinical Informatics, which is cosponsored by the American Board of Pathology. (11)

For training delivery purposes, the outcomes were organized into 4 groupings, named the PIER Essentials, presenting the recommended sequence for residents to build their pathology informatics knowledge and skills over time (Figure 1).

During the development process, work group members mapped the PIER Essentials to the Accreditation Council for Graduate Medical Education (ACGME) Milestones. (12) The milestones represent the knowledge, skills, attitudes, and other attributes for each of the ACGME competencies that all pathology residents are expected to achieve in the course of their training. (12) Milestones Systems-Based Practice 7 (SBP7) deals specifically with competencies related to clinical informatics in anatomic and clinical pathology. (12) The relationship of the PIER Essentials to Milestone SBP7 is illustrated in Figure 2.

The work group identified key learning resources for the informatics topics in each of the PIER Essentials, such as book and journal references and online training modules. The group also developed practical exercises aimed at reinforcing informatics knowledge with hands-on experience. This work formed the basis of the PIER Resource Toolkit, an interactive set of 3 instructional process tools that support delivery of each of the 4 PIER Essentials (Figures 3 through 5).

The work group met regularly by conference calls from January to September 2014. A subset of the work group met in person to finalize the curriculum and instructional framework (ie, PIER Essentials) and curated list of associated resource options, and to determine the structure of the PIER Resource Toolkit. A core team of informatics and education leaders from CAP, APC, and API provided oversight and project management throughout the development process and continues to manage the initiative.

RESULTS

The PIER prototype (Release 0) was introduced at the July 2014 APC Annual Meeting. PIER Release 1 was made available to all residency programs on the APC Web site in September 2014 and was concurrently alpha tested by 12 residency programs (Table 2) during that academic year. Preliminary alpha test findings indicate that PIER is effective. Release 2 is currently in development and scheduled for release in the summer of 2016. PIER's content relevance is intended to be maintained via new releases, updating the subject matter and instructional process tools for program directors and faculty to provide continuously improved informatics training to their residents while continuing to meet ACGME Informatics Milestone requirements.

PIER Essentials

The PIER Essentials present up-to-date pathology informatics training topics based on 38 peer-reviewed outcome statements (Appendix). PIER aims to integrate informatics education into pathology residents' anatomic and/or clinical pathology rotations and into residency activities related to management, quality assurance and control, regulatory and accreditation issues. PIER Essentials also include aspects of laboratory information and systems in the greater health care information domain, including electronic health records (Figure 1).

The PIER Essentials successively build on each other with increasing complexity, as indicated by the stated proficiency levels. Residency programs may control the timing by year to suit the scheduling availability of postgraduate year (PGY) 1 to PGY 4 residents; however, it is important that the order be followed because the knowledge and skills build in sequence. The estimated instructional hours for each PIER Essentials are based on the approximate time it takes to complete the recommended approach for each of the topics in each of the Essentials. The number of instructional hours may be adjusted on the basis of the final number and type of resource options, and instructional strategies selected by the program director.

Alignment With ACGME Milestone SBP7

The 4 PIER Essentials are mapped to Levels 1 to 4 in ACGME Pathology Informatics Milestone SBP7: "Explains, discusses, classifies, and applies clinical informatics" (Figure 2). PIER focuses on preparing all residents to achieve Levels 1 to 4 during residency and is an effective resource for aspiring informatics specialists to develop prerequisite pathology informatics knowledge and skills before advanced training or fellowships.

While PIER enables residents to meet ACGME Milestone SBP7 Levels 1 to 4, the PIER outcome statements specify a complete set of pathology informatics knowledge and skills that a resident needs to have upon completion of his/her residency program to practice pathology (Appendix). PIER is scoped and sequenced to achieve the outcomes, which are more specific and more directly aligned with practice needs than the high-level Milestone statements.

ACGME Milestone Level 5 is beyond PIER's purpose and scope. The ACGME defines Level 5 as follows: "The resident has advanced beyond performance targets set for residency and is demonstrating 'aspirational' goals which might describe the performance of someone who has been in practice for several years. It is expected that only a few exceptional residents will reach this level."12 PIER focuses on preparing residents to achieve Levels 1 to 4 during residency and is not intended for residents or fellows pursuing advanced training in informatics.

PIER Materials

PIER materials consist of 2 key components: an Instructional Resource Guide and Resource Toolkit. These and other support materials are freely available to download from http://www.apcprods.org/PIER (accessed April 6, 2016). The Instructional Resource Guide orients program directors to PIER's rationale and approach, the PIER Essentials, and the PIER Resource Toolkit. The Resource Toolkit provides 3 interactive tool templates that program directors and residents can use to plan, customize, implement, and manage the 4 PIER Essentials. These tools include (1) an Essentials Map that identifies the topics, topic rationale, key outcomes, topic content, rotation options, and delivery options for each of the Essentials (Figure 3); (2) PIER Resource Options that include a recommended set of reference resources and practical training exercises for each topic (Figure 4); and (3) an Essentials Outcomes Achievement Checklist that tracks accomplishment of each outcome statement; successful completion of each of the Essentials indicates achievement of the corresponding ACGME Milestone level (Figure 5).

PIER provides the curriculum and process for residency programs to develop and customize their own self-study modules, lecture series, and blended learning units. Users can add and maintain their own tools and content in their Resource Toolkit electronic files. PIER is flexible and scalable for programs to best meet their local needs, philosophy, and circumstances. Because of the importance of learning the principles and practice of informatics in the context of actual pathology practice, PIER is designed as a longitudinal experience for residents, with learning activities and practical hands-on exercises spanning the 4 years of anatomic pathology-clinical pathology (AP-CP) or 3 years of straight AP or CP residency, and can be embedded in existing AP and/or CP rotations.

Flexible Design

The overarching goal of PIER is that residents build basic competency in pathology informatics. PIER recognizes that the GME pathology informatics space is growing with a variety of diverse topics, approaches, and materials, at varying costs and from multiple providers. Because programs have varied internal expertise, budgets, and education strategy preferences, PIER has built-in design agility, is free of charge, and includes only no-cost and relatively low-cost learning resources. PIER also serves as a framework for other informatics training content. The curriculum can be supplemented with a variety of additional teaching resources and tools from internal and external providers as they become available.

IMPLEMENTATION

PIER is supported by a 4-phase, multiyear change management strategy designed to test and support delivery of GME informatics training across all US pathology residency programs. The change management strategy engages and supports residency programs in the successful implementation of PIER incrementally over time, recognizing that programs will have varying adoption types (Table 3) and motivations. As such, program directors can leverage the PIER curriculum and instructional process tools to guide the training decisions that are most appropriate to their program.

The change management framework and associated terminology (eg, early adopters, early majority, late majority, late minority) developed for PIER is adapted from Diffusion of Innovations.13 The adoption phases, timeline, forecasted adoption rate, and PIER release schedule are presented in Table 3. The communication and engagement methods for each phase are influenced by the adoption attributes of the residency programs in a given phase. Implementing PIER by applying proven innovation diffusion and change management practices should increase PIER's usage, as the key stakeholders are engaged and supported during the 4 phases. The application of the model referenced above as related to the development of PIER is described below.

Phase 1 - Socialization

During this phase, PIER and its prototype (Release 0) were introduced to residency program directors and chairs at the July 2014 APC Annual Meeting, and PIER's informational Web page on APC's Web site was launched. PIER was presented to department chairs at the APC regional meetings (September to October 2014) and featured in the APC September 2014 issue of the Paths to Progress newsletter. PIER was also presented locally by CAP members at multiple academic institutions (August to November 2014). As a result, key stakeholders were informed and educated about PIER and were invited to evaluate it for use at their own institutions.

Phase 2 - Testing/Validation

At the July 2014 APC Annual Meeting, more than 30 pathology residency programs expressed a desire to participate in an alpha test to validate PIER Release 1, initially released to all residency programs in September 2014. Alpha test programs were selected to achieve diversity on criteria that included program size, access to informatics experts/faculty, and geographic location. Twelve programs (Table 2) participated in data collection events between November 2014 and October 2015. Data collection events included online surveys, phone interviews, and virtual focus groups. Nine additional residency programs indicated that they used PIER Release 1 and participated in an online survey. Based on valuable feedback received from these 21 programs, PIER Release 2 is in development and will be available by summer of 2016. From this group of "early adopters," PIER champions, consisting of both program directors and residents, have emerged and are expected to play a key role in attracting "early majority" residency programs.

Phase 3 - Deployment

The goal of deployment is to attract and to motivate the "early majority" group of programs (n = 50) to adopt PIER during a 2-year cycle time (July 2015-June 2017). The "early majority" group tends to rely upon the "early adopters" for social proof and usage validation before making a decision. Communications and engagement methods currently in development will provide the "early majority" program directors with the information and experiences of the "early adopter" alpha test programs necessary to support them in their decision-making process.

Phase 4 - Sustainment

The goal of Phase 4 is similar to Phase 3, yet recognizes that the late majority" are characteristically a conservative and/or skeptical group. The intention is to attract and to motivate the "late majority" program directors (n = 50) to adopt PIER during the subsequent 2-year cycle time (July 2017-June 2019). The approach will feature evidence of resident outcome achievement, and details of the successes of early adopter" and early majority" programs. The communication and engagement plan will be developed in late 2016, applying lessons learned from Phase 3 (Deployment).

Each phase of the change management strategy is specific to the adoption attributes of the program population. Overall, the change management strategy seeks to attract pathology residency programs to use PIER as a best practice curriculum standard and helpful instructional resource; to advocate for its consideration and proper use; to support PIER's adoption and ongoing use across residency programs; and to support use of any and all relevant materials in the delivery of GME informatics training and education. Further to the latter point, PIER is not a commercial product and has no commercial ties.

DISCUSSION

As early as 1977, Aller et al (14) described the benefits of computerization for the pathology laboratory. Korpman15 described how pathologists are well suited to play a leadership role as information managers in health care organizations. Friedman (16) first used the term pathology informatics in describing the need for a locus of responsibility and expertise in informatics within pathology departments. Sinard and Morrow (17) described a vision of the pathologist as an information integrator at the center of diagnostics in patient care. Not surprisingly, a 2007 survey of pathology group leaders (18) cited informatics as one of the most important skill sets for newly hired pathologists. In the current era of information-rich medical practice, and with the development of new informatics-intensive laboratory technologies such as electronic health record-related meaningful use requirements, digital pathology, nextgeneration sequencing, and computational pathology, demand will increase on the pathology community to invest in informatics initiatives and resources, train more pathology informaticists, and educate all pathology residents about informatics.

There have been several recent initiatives highlighting the importance of effective education in informatics for pathology residents. The ACGME's development and adoption of Milestone SBP7 (Figure 2) has formalized the need for training in informatics for all pathology residents and achievement of an acceptable level of competency by all residents in the course of their training. A new subspecialty Board Certification in Clinical Informatics, cosponsored by the American Board of Pathology and the American Board of Preventive Medicine, is now available. While the new board certification does not relate to residency training per se, it does reflect an endorsement of the importance of informatics in medicine, and specifically in pathology practice. The core content for the certifying Board Examination in Clinical Informatics was previously published11; this content was examined and analyzed during the preparation of PIER.

As based on several surveys that examined informatics training in pathology residency programs (5,6) and on anecdotal feedback received by APC's residency program directors' section (PRODS), informatics training in pathology residency programs has been largely suboptimal. While some programs have developed novel methods, such as virtual rotations and wikis, to expose their residents to informatics, (19,20) most programs in the United States are not teaching their pathology residents adequately.

During the past 25 years, there have been multiple proposals for elements of a curriculum in informatics for pathology residents. (4,7,21-27) In general, these proposals have focused on topics centered largely on information technology. In 2003, a comprehensive curriculum that detailed learning objectives and skill sets in informatics for pathology residents was published. (4) This included recommendations for demonstrating knowledge of and competence in informatics topic areas that are germane to pathology practice. Harrison (28) described in detail questions and methods for evaluating informatics training in a pathology residency program. More recently, Rao and Gilbertson (27) described their institution's approach to incorporating informatics experiences into general pathology residency training.

None of these training proposals has been widely implemented, at least partly because other priorities compete with informatics for time during residency training, there is a perceived lack of informatics resources and training materials, and pathology faculty generally lack informatics expertise. (29) The CAP, APC, and API considered that these resource gaps might be mitigated at least in part by a standardized, expert-endorsed, practice-oriented pathology informatics curriculum. The fact that PIER was developed by and is supported by the CAP, APC, and API likely accounts for the keen interest in PIER so far received from the pathology community at-large, and the current level of willingness of program directors to implement PIER.

Overall, the PIER curriculum provides a useful and reliable subject matter framework for pathology residency programs regarding "what to teach" and low-cost options for "how to teach it." PIER was not intended to provide off-the-shelf, prepackaged content to teach informatics. For this content, programs rely on available resources (eg, textbooks, literature, online information) and/or materials (eg, didactic lectures, handouts, exercises, demonstrations) developed by the individual programs themselves or available from outside sources. Each residency program will make cost/ benefit decisions on the basis of their own available resources. Program directors can reference the PIER curriculum to determine which instructional materials they want to make or buy, using the instructional process tools to document and track their decisions.

Identifying reasonable subject management scope for residents in pathology informatics training was challenging. The field of informatics is broad and encompasses many diverse topics, and these topics continue to evolve and to expand rapidly as a result of advancing technology and emerging regulations. At the outset, the PIER work group believed that trying to educate pathology residents about all of these topics in the limited time available during residency was impractical and unnecessary, and so they researched and developed the 38 peer-reviewed outcome statements (30) identifying the competence that a resident should have in pathology informatics upon completion of his/her residency program.

Informatics has been incorporated into residency training in other medical specialties. (31-33) The objective for some of these specialties was to familiarize their residents with clinical information technology applications that could enhance their productivity in clinical practice. (34) Evaluation of these approaches proved to be invaluable, as it influenced important decisions regarding PIER's format and curriculum. For example, because residents did not find detailed background in information technology to be of immediate clinical value, more attention was directed toward teaching practical skills and reinforcing these during clinical residency.

The working group made decisions about the scope of informatics topics suitable to include in general resident training. Many topics that might be considered by some to be pathology informatics topics, such as computer programming, database administration, advanced statistics, and bioinformatics, were identified to be out of scope for PIER. The working group had difficulty deciding how best to position and cover the field that has been termed computational pathology. (9) While all working group members agreed that in this "big data" era of health care there is an opportunity for pathology to take the lead, (9) the field of computational pathology is still emerging, the methods used are beyond basic informatics (eg, it can involve advanced computational modeling or machine learning), and it is not yet in routine use in most pathology laboratories. As a result, computational pathology was incorporated only as a minor component in PIER Essentials 2 (Figure 1). That said, many of the other topics within PIER are expected to help prepare pathology residents to eventually use computational pathology in their future practice, should the need arise.

The primary target audience for PIER is pathology residency program directors and administrators who have responsibility for training residents and preparing them generally for practice. Secondary audiences may include undergraduate medical education directors and students interested in knowing or understanding what is required in pathology informatics for a resident. PIER is also anticipated to be a useful resource for aspiring specialists to develop prerequisite pathology informatics knowledge and skills before advanced training or fellowships in pathology and/or clinical informatics. Although practicing pathologists may also use PIER as a resource for continuing education in informatics, it was not designed specifically for this purpose.

To date, PIER has been well received by the pathology community and the alpha test programs. Alpha test program directors reported PIER effectively supports residency training programs in implementing/improving informatics training; the PIER Essentials include highly relevant and important training topics; PIER allocates time for training on those topics; it includes recommended learning resources and practical exercises; and the Outcomes Achievement Checklists provide a useful tool for documenting Milestone achievement. (35) In addition, alpha test residents, faculty, and program directors reported an increase in residents' knowledge/skill related to the PIER outcome statements. Most alpha test program representatives report that they would be willing to recommend PIER to other programs. (35)

Although program directors who participated in the PIER alpha test report satisfaction with PIER, they continue to raise the same implementation concerns reported in the literature to date. Lack of time and faculty expertise are the greatest challenges to implementing PIER. (35) It is difficult to work new topics into an existing curriculum and a set training schedule that is already fully scheduled. The time issue is compounded by the lack of available off-the-shelf, prepackaged pathology informatics training materials. Regarding the second greatest challenge reported, many pathology departments currently lack sufficient numbers of faculty members skilled in informatics. In the context of family medicine residency, it has been shown that successful education of residents in informatics depends on making sure the teachers themselves are skilled in the use of information technology tools. (36) Although nonpathology faculty and staff, such as information technology or laboratory information system support staff members, are available in some departments to assist in informatics teaching, pathology residency programs do not necessarily have ready access to these types of instructors.

CONCLUSIONS

PIER is a highly adaptable curriculum and instructional framework that pathology residency programs may use to address the pressing need for informatics training for all pathology residents. This standardized, yet flexible, curriculum is designed to align with the relevant ACGME Pathology Milestones and can be implemented in residency programs of varying size and with diverse needs, settings, and resources. There are practical implementation challenges with curriculum additions, particularly lack of time and faculty expertise. The hope is that program directors and pathology informatics experts can work to solve these challenges together in the near future. The intention is that PIER will be widely adopted by program directors and it will help to better prepare all pathology residents for the modern practice of pathology.

We recognize and gratefully acknowledge the members of the PIER work group: Walter H. Henricks, MD (co-leader), Liron Pantanowitz, MD (co-leader), Donald S. Karcher, MD (core team), Raymond D. Aller, MD, Philip J. Boyer, MD, PhD, Victor B. Brodsky, MD, Alexis B. Carter, MD, Rajesh C. Dash, MD, Michael D. Feldman, MD, PhD, John R. Gilbertson, MD, James H. Harrison Jr, MD, PhD, Anil V. Parwani, MD, PhD, Suzanne Z. Powell, MD, Michael W. Riben, MD, Rodney A. Schmidt, MD, PhD, John H. Sinard, MD, PhD, Enrique Terrazas, MD, J. Allan Tucker, MD, J. Mark Tuthill, MD, MS, and Myra Wilkerson, MD. We thank Ann Neumann, PhD, vice president, CAP Learning, and Priscilla Markwood, executive director of the Association for Pathology Chairs, for their thoughtful leadership, education expertise, and review of this manuscript. We also thank Sue Plath, MA, Trish Glover, MS, and Arlene Thompson, MSEd of CAP Learning for guiding us through the process of developing the PIER curriculum and the change management strategy, and for reviewing this manuscript.

References

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APPENDIX

The Pathology Informatics Essentials for Residents (PIER) Outcomes for Achievement statements were sourced from the Informatics Competency developed by the College of American Pathologists (CAP). The CAP Competency Model30 is a peer-reviewed set of knowledge and skill statements written by experts in the various areas of pathology. Its intended audience is practicing pathologists for use in determining their professional development needs and also to guide CAP Learning in the development of graduate medical education (GME) activities.

PIER Outcomes for Achievement

This section presents the master list of 38 statements identifying the knowledge and skills that a resident should have upon completion of his/her residency program to practice pathology.

These outcomes are organized into 7 topic areas; they are not organized in the sequence in which a resident would learn them. This list provides a useful master list of the outcomes by topics, independent of the sequence in which they are taught. For resident training purposes, the outcomes are organized into the 4 PIER Essentials, displaying the recommended sequence for residents to successfully build their pathology informatics knowledge and skills over time (Figure 1).

Technology Fundamentals

1. Understand the relevance of informatics in pathology practice.

2. Explain the salient differences and similarities among pathology informatics, bioinformatics, public health informatics, and health care information technology and health knowledge informatics.

3. Use correct terminology to describe the major types and components of computer hardware, software, and computer networks.

4. Be conversant in the fundamentals of databases, including data types, fields, records, database structure, and mechanisms for querying data; understand how data storage affects data retrieval options.

5. Recognize the advantages of standardized terminology for creating interchangeable data, which can be retrieved and summarized.

6. Define the key features of communication standards used in pathology, such as Health Level 7 (HL7) and Digital Imaging and Communications in Medicine (DICOM).

7. Define the types and roles of standards used in pathology, at a basic level.

8. Understand the basics of the standards development process (includes International Organization for Standardization [ISO] organizations such as HL7 and also other processes important in standards development such as Integrating the Healthcare Enterprise [IHC] and Office of the National Coordinator for Health Information Technology [ONC]).

9. Understand how patient and asset identification standards and tracking systems are used to improve patient safety and laboratory workflow.

10. Recognize applications of ancillary information systems to optimize clinical, operational, and financial performance of the laboratory (eg, middleware, financial systems, and business intelligence).

Laboratory Information Management in Health Systems

11. Recognize what laboratory information systems (LISs) are, what they do, and the role they play in efficient laboratory operations and health care delivery.

12. Identify opportunities to modify the LIS to improve operations.

13. Understand capabilities and limitations of electronic interfaces between an LIS and instrumentation, middleware, and other information systems.

14. Anticipate (and recommend remediation for) issues, potential problems, and challenges in electronic health record (EHR) handling of laboratory test results.

15. Anticipate (and recommend remediation for) issues, potential problems, and challenges in EHR handling of laboratory test orders.

16. Articulate the role and connections of the LIS within the network of health care information systems (ie, the local health care information ecosystem).

17. Describe middleware, how it relates to the LIS, and roles for middleware in laboratory operations.

18. Understand the special difficulties of information flow to and from the local information ecosystem (eg, for outreach programs) and strategies for overcoming the obstacles.

19. Understand the elements of data availability as a key part of security.

20. Follow technology developments and identify opportunities for improving the security and quality of patient data.

Data Analysis and Management Tools

21. Recognize limitations and information gaps resulting from the limitations of the data analysis capability of LISs.

22. Contribute to the definition and creation of integrated health care data sets from multiple disparate sources to support useful, accurate, and reliable data analysis.

23. Contribute to the analysis and interpretation of integrated pathology and enterprise data sets for improving care quality and increasing the efficiency of care delivery.

Digital Pathology

24. Use digital imaging systems such as whole slide imaging (WSI), telemicroscopy, and image analysis (as appropriate to practice setting).

25. Understand potential role, use, and limitations of WSI in the laboratory environment.

26. Determine the appropriate digital image resolution for a particular need/purpose.

27. Determine the appropriate telemicroscopy technology to use for a particular application.

Ongoing Laboratory System Management

28. Work with information systems personnel to ensure that reports are properly formatted (eg, synoptic format and other standardized formats as appropriate).

29. Supervise the LIS team in the creation and updating of the LIS procedure manual.

30. Understand the process and requirements for test definition and other information maintenance in the LIS.

Accreditation and Regulatory Compliance

31. Maintain compliance with electronic information management requirements of regulatory and/or accreditation agencies (focus on regulatory perspective, management, and inspection perspective of topic).

32. Follow technology developments and identify opportunities for improving the security and quality of patient data.

33. Interpret new regulations to determine how they affect laboratory information management needs and the role of the laboratory within the health care system.

34. Adhere to HIPAA (Health Insurance Portability and Accountability Act) and other security and privacy requirements for the communication and storage of patient data (eg, correct use of password-protected accounts, firewalls, digital certificates, encryption, and 2-factor authentication).

35. Recognize situations under which information technology may be subject to US Food and Drug Administration (FDA) regulation (eg, blood banking and WSI).

36. Comply with positive patient identification processes/ protocols.

Selection and Installation of Laboratory Systems

37. Explain the role and responsibility of pathologists with regard to the selection, oversight, and use of informatics systems in the function of the modern pathology laboratory.

38. Provide input to the LIS selection team to ensure that an optimal fit between a purchased system and departmental needs is attained.

Walter H. Henricks, MD; Donald S. Karcher, MD; James H. Harrison Jr, MD, PhD; John H. Sinard, MD, PhD; Michael W. Riben, MD; Philip J. Boyer, MD, PhD; Sue Plath, MA; Arlene Thompson, MSEd; Liron Pantanowitz, MD

Accepted for publication May 4, 2016.

Published as an Early Online Release July 6, 2016.

From the Pathology and Laboratory Medicine Institute, Center for Pathology Informatics, Cleveland Clinic, Cleveland, Ohio (Dr Henricks); the Department of Pathology, George Washington University School of Medicine and Health Sciences, Washington, DC (Dr Karcher); the Departments of Public Health Sciences and Pathology, University of Virginia School of Medicine, Charlottesville (Dr Harrison); the Department of Pathology, Yale School of Medicine, New Haven, Connecticut (Dr Sinard); the Department of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston (Dr Riben); the Department of Pathology, East Carolina University, Brody School of Medicine, Greenville, North Carolina (Dr Boyer); CAP Learning, College of American Pathologists, Northfield, Illinois (Mses Plath and Thompson); and the Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (Dr Pantanowitz).

The authors have no relevant financial interest in the products or companies described in this article.

This seminal article reflects a collaboration among the College of American Pathologists, Association of Pathology Chairs, and Association for Pathology Informatics, and will be jointly published by invitation and consent in the Archives of Pathology & Laboratory Medicine, Academic Pathology, and Journal of Pathology Informatics. It has been edited in accordance with the style of the Archives of Pathology & Laboratory Medicine.

Reprints: Walter H. Henricks, MD, Pathology and Laboratory Medicine Institute, Center for Pathology Informatics, Cleveland Clinic, L21, 9500 Euclid Ave, Cleveland, OH 44195 (email: henricw@ccf.org).

Please Note: Illustration(s) are not available due to copyright restrictions.

Caption: Figure 1. Pathology Informatics Essentials for Residents - Curriculum Scope and Sequence (PIER Release 1). Abbreviations: ACGME, Accreditation Council for Graduate Medical Education; EHR, electronic health record; LIS, laboratory information systems; PIER, Pathology Informatics Essentials for Residents.

Caption: Figure 5. Pathology Informatics Essentials for Residents - Essentials 1 Outcomes Achievement Checklist (PIER Release 1 - subject to change in Release 2 [summer, 2016]). Abbreviations: ACGME, Accreditation Council for Graduate Medical Education; PIER, Pathology Informatics Essentials for Residents.
Table 1. Factors Driving the Prominence of
Informatics in Pathology Practice (Alpha Order)

ACGME resident Milestones incorporating informatics
Automation in the laboratory
Business intelligence capabilities
Clinical informatics board certification
Consolidation of health care organizations and laboratory
   services
Digital pathology (ie, whole slide imaging and related
   technologies)
EHR adoption, including CPOE
HIT regulations (eg, "Meaningful Use")
Information privacy and security requirements (HIPAA)
Lean processing and principles in laboratory practice
Next-generation sequencing for genomic analysis
Patient safety and specimen tracking

Abbreviations: ACGME, Accreditation Council for Graduate Medical
Education; CPOE, computerized provider order entry; EHR, electronic
health record; HIPAA, Health Insurance Portability and Accountability
Act; HIT, health information technology.

Table 2. Pathology Informatics Essentials for
Residents (PIER) Alpha Test Residency Programs

Baystate Medical Center, Springfield, Massachusetts
Cleveland Clinic, Cleveland, Ohio
The George Washington University, Washington, DC
Medical University of South Carolina, Charleston
University of Buffalo, Buffalo, New York
University of Kentucky, Lexington
University of Miami, Miami, Florida
University of New Mexico, Albuquerque
University of Pittsburgh, Pittsburgh, Pennsylvania
University of Southern California, Los Angeles, California
University of Toledo, Toledo, Ohio
University of Vermont, Burlington

Table 3. Pathology Informatics Essentials for
Residents (PIER) Change Management Framework (a)

                     Phase 1          Phase 2        Phase 3
                  Socialization       Testing       Deployment

Timeline          Mid 2014         Late 2014-2015   2015-2017

Adoption          Not applicable   Early adopters   Early
types                                               majority

Projected         Not applicable   21 (15%)         50 (35%)
adoption rate
- US programs
([+ or -] 144)

PIER release      Release 0        Release 1        Release 2

                     Phase 4           Beyond
                   Sustainment        Phase 4

Timeline          2017-2019       Beyond 2019

Adoption          Late majority   Late minority
types

Projected         50 (35%)        22 (15%)
adoption rate
- US programs
([+ or -] 144)

PIER release      Release 3       To be determined

(a) Framework based on Rogers. (13)

Figure 2. Pathology Informatics Essentials for Residents--Mapped
to Accreditation Council for Graduate Medical Education Pathology
Informatics Milestone SBP7 for Systems-Based Practice Competency
(PIER Release 1). Abbreviations: APCP, anatomic pathology and
clinical pathology; PIER, Pathology Informatics Essentials for
Residents; SBP7, Pathology Milestone Systems-Based Practice
Subcompetency 7.

SBP7: Informatics: Explains, discusses, classifies,
and applies clinical informatics (APCP)

Has not          Level 1            Level 2            Level 3
Achieved
Level 1

             Demonstrates       Understands lab    Applies
             familiarity        specific           informatics
             with basic         software, key      skills as
             technical          technical          needed in
             concepts of        concepts and       project
             hardware,          subsystems on      management
             operating          interfaces,        (data
             systems, and       workflow,          management,
             software for       barcode            management,
             general purpose    applications,      computational
             applications.      automation         statistics).
                                systems
                                (enterprise
                                systems
                                architecture).

Comments:          E-1                E-2                E-3

Has not               Level 4                     Level 5
Achieved
Level 1

             Participates in             Is proficient in medical
             operational and strategy    informatics systems.
             meetings, apprentices       Able to assess and
             troubleshooting with        purchase a laboratory
             Information Technology      information system for
             (IT) staff, applies         anatomic and/or clinical
             informatics skills in       pathology laboratories.
             laboratory management       Able to utilize medical
             and integrative             informatics in the
             bioinformatics (able to     direction and operation
             aggregate multiple data     of the laboratory.
             sources and often
             multiple data analysis
             services).

Comments:               E-4

Figure 3. Pathology Informatics Essentials for
Residents--Essentials 1 Map (PIER Release 1--subject to change
in Release 2 [summer, 2016]). Abbreviations: E1, Essentials 1;
PIER, Pathology Informatics Essentials for Residents.

Essentials 1 - Map

Estimated Time: 4-6 hours

Topic Title       Informatics in              Information Systems
                  Pathology Practice          Fundamentals

Rationale         The practice of             Computers are
                  pathology relies on the     essential tools that
                  creation, management,       pathologists use in the
                  and accurate and timely     management of
                  communication of            information for
                  clinical laboratory         laboratory practice and
                  information.                patient care.

PIER Outcomes     Understand the              Use correct
                  relevance of                terminology to describe
                  informatics in              the major types and
                  pathology practice.         components of
                                              computer hardware,
                  Describe the difference     software, and
                  between information         computer networks.
                  technology (IT) and
                  informatics and
                  recognize how
                  pathologists contribute
                  to informatics
                  initiatives.

                  Explain the salient
                  differences and
                  similarities among
                  pathology informatics,
                  bioinformatics, public
                  health informatics,
                  health care information
                  technology, and health
                  knowledge informatics.

Content           1. Definition of            1. Hardware
                     informatics              2. Software
                  2. Relevance of             3. Networks
                     informatics in           4. Communications
                     pathology                5. Internet/Web
                  3. Different types of
                     informatics
                  4. The practice of
                     informatics in
                     pathology

Start Date        Click here to enter         Click here to enter
                  a date.                     a date.

Rotation
(Click and        Choose a rotation.          Choose a rotation.
select a
rotation)         Click here to enter         Click here to enter
Additional        text.                       text.
Rotations/
Comments

Implementation
Preferences       [] Program Lecture          [] Program Lecture
(Select all
that apply)       [] PIER Resource Options    [] PIER Resource Options

                  [] Outside Resources        [] Outside Resources

                  [] Mentor/Preceptor         [] Mentor/Preceptor

Comments          Click here to enter         Click here to enter
                  text.                       text.

Other             Click here to enter         Click here to enter
Implementation    text.                       text.
Preferences
(Identify your
own existing
materials)

Check Progress    Click here to enter a       Click here to enter a
                  date.                       date.

E1 Wrap-Up                                    Click here to enter text.
Date

(Expected PIER Essentials 1 Outcomes
Achievement Checklist completion date)

Topic Title       Importance of Databases     Introduction to Data
                                              Standards

Rationale         Databases provide           Standards enable
                  core structure and          sharing of data among
                  tools that enable           different health care
                  pathologists to manage      information systems (ie,
                  and analyze large           interoperability), which
                  amounts of information.     is necessary for patient
                                              care.

PIER Outcomes     Conversant in the           Define the types and
                  fundamentals of             roles of standards used
                  databases (including        in pathology, at a basic
                  data types, fields,         level.
                  records, database
                  structure, and
                  mechanisms for
                  querying data);
                  understands how data
                  storage affects data
                  retrieval options.

Content           1. Database                 1. Messaging protocols
                     terminology              2. Data models
                  2. Structured vs.           3. Interoperability
                     Unstructured data        4. Introduction to
                  3. Types of databases          coding systems
                  4. Use of databases

Start Date        Click here to enter         Click here to enter
                  a date.                     a date.

Rotation
(Click and        Choose a rotation.          Choose a rotation.
select a
rotation)         Click here to enter         Click here to enter
Additional        text.                       text.
Rotations/
Comments

Implementation
Preferences       [] Program Lecture          [] Program Lecture
(Select all
that apply)       [] PIER Resource Options    [] PIER Resource Options

                  [] Outside Resources        [] Outside Resources

                  [] Mentor/Preceptor         [] Mentor/Preceptor

Comments          Click here to enter         Click here to enter
                  text.                       text.

Other             Click here to enter         Click here to enter
Implementation    text.                       text.
Preferences
(Identify your
own existing
materials)

Check Progress    Click here to enter a       Click here to enter a
                  date.                       date.

E1 Wrap-Up
Date

(Expected PIER Essentials 1 Outcomes
Achievement Checklist completion date)

Topic Title       Data Availability & Security

Rationale         Pathologists are
                  ultimately responsible
                  for the access to and
                  safety of pathology information.

PIER Outcomes     Understand the
                  elements of data
                  availability as a key
                  part of security.

Content           1. Data protection and
                  confidentiality
                  2. Data availability &
                  integrity
                  3. Data backup &
                  recovery

Start Date        Click here to enter a date.

Rotation
(Click and        Choose a rotation
select a
rotation)         Click here to enter text.
Additional
Rotations/
Comments

Implementation
Preferences       [] Program Lecture
(Select all
that apply)       [] PIER Resource Options

                  [] Outside Resources

                  [] Mentor/Preceptor

Comments          Click here to enter text.

Other             Click here to enter text.
Implementation
Preferences
(Identify your
own existing
materials)

Check Progress    Click here to enter a date.

E1 Wrap-Up
Date

(Expected PIER Essentials 1 Outcomes
Achievement Checklist completion date)

Figure 4. Pathology Informatics Essentials for Residents - Essentials
1 Resource Options (PIER Release 1 - subject to change in Release 2
[summer, 2016]). Abbreviation: PIER, Pathology Informatics Essentials
for Residents.

Essentials 1 - PIER Resource Options

Topic 1:       Informatics in Pathology Practice

Rationale      The practice of pathology relies on the creation,
               management, and accurate and timely communication of
               clinical information.
PIER           Understand the relevance of informatics in pathology
               practice.
Outcomes       Describe the difference between information technology
               (IT) and informatics and recognize how pathologists
               contribute to informatics initiatives.
               Explain the salient differences and similarities among
               pathology informatics, bioinformatics, public health
               informatics, health care information technology, and
               health knowledge informatics.

Content        1. Definition of informatics
               2. Relevance of Informatics in pathology
               3. Different types of informatics
               4. The practice of informatics in pathology

Recommended PIER Resource Options (Check options to be completed)

[] Carter AB, Mcknight RM, Henricks WH, Moore GW, Saltz JH. Pathology
Informatics: An Introduction. In: Pantanowitz L, Tuthill
JM, Balis UGJ. Pathology Informatics: Theory and Practice. Chicago,
IL: ASCP Press; 2012.

[] Harrison J. Management of Pathology Information Systems. In: Wagar
EA, Horowitz RE, Siegal GP. Laboratory Administration
for Pathologists. Northfield, IL: CAP; 2011.

Practical Exercises (Check options to be completed)

[] Informatics is embedded throughout pathology practice and
laboratory activities. However, most residents do not realize just
how much informatics they are learning as part of their routine
pathology training because this training is not specifically
identified as informatics. During rotations have the resident
identify and recognize specific "moments" when informatics comes
into play. Discuss informally with more senior residents, staff
pathologists, or informatics faculty to understand better the
implications for patient care and laboratory operations.

[] During rotations have the resident keep a log of
informatics-related activities and questions that occur
(eg, do this for one week on each rotation).

[] During a resident group meeting, provide an opportunity for
residents to share their varied experiences, observations, and
questions from their informatics log.

Comments

Click here to enter text.      Completion Date
                               Click here to enter a date.

Optional Resources

Sinard JH, Morrow JS. Informatics and anatomic pathology: meeting
challenges and charting the future. Hum Pathol.
2001;32(2):143-148.

Sinard JH, Powell SZ, Karcher DS. Pathology training In informatics:
evolving to meet a growing need. Arch Pathol Lab Med. April
2014;138(4):505-511.

Sinard JH. The Scope of Pathology Informatics. In: Slnard JH.
Practical Pathology Informatics. New York, NY: Springer Science +
Business Media. Inn: 2006.
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Author:Henricks, Walter H.; Karcher, Donald S.; Harrison, James H., Jr.; Sinard, John H.; Riben, Michael W.
Publication:Archives of Pathology & Laboratory Medicine
Date:Jan 1, 2017
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