With growth spurred by recent federal efforts, electronic health records (EHRs) are transforming the practice of medicine and have important implications for pathologists, their laboratories, and the patients they serve. Beyond new EHR-related regulatory requirements, EHRs fundamentally alter the way clinicians interact with laboratory information, including test order entry and result reviewing. This article is the first in a series of 5 related articles whose goal is to provide a “framework” for empowering pathologists to adapt to, and to succeed in, the era of expanding EHR use. This series aims to describe the environment for EHR uptake, to raise awareness of EHR-related issues that pathologists and laboratories face, and to explore new professional roles for pathologists as stewards of patients' laboratory information in EHRs.

The increasing use of electronic health records (EHRs) has profound implications for pathology's core mission of delivering vital patient care information to health care providers. The use of EHRs in physician practices and health care organizations is here, is growing, and will continue to expand. The most important driver is recent federal actions that promote EHR use, most prominently, the EHR Incentive Program (commonly known as meaningful use). The expansion of EHR usage is changing the paradigm by which laboratory information is communicated and translated into clinical action and is transforming the practice of medicine and health care information management. Widespread EHR adoption offers opportunities to, and imperatives for, pathologists to take on transformative professional roles and responsibilities.

This article is the first in a series of 5 related articles whose goal is to provide a “framework” that will empower pathologists to succeed in the era of the EHR. This series will provide guidance to pathologists and their laboratories on how best to adapt to, and succeed in, the environment of expanding EHR usage. Understanding and addressing the implications of EHR emergence is crucial to the future health of the specialty of pathology. In this first article, we will describe the current and expected contexts for EHR uptake and introduce the challenges, imperatives, and opportunities that pathologists and laboratories face with increased deployment of EHRs. We recognize that this is a complex situation with many stakeholders, most of whom wield regulatory and/or reimbursement power; the associated articles in this series highlight the responsibilities of the laboratory, and ultimately, its laboratory director, to meet those requirements and ensure quality patient care.

## ENVIRONMENT FOR EHR UPTAKE

### EHR—Definition, Components, and Status

The EHR is a longitudinal record of a patient's health care spanning inpatient and ambulatory environments.1  The definition of an EHR in federal law2  includes (1) patient demographic and clinical health information, such as medical history and problem lists (which includes laboratory results); (2) computerized physician order entry (which includes laboratory tests); (3) clinical decision support; (4) capability to exchange and integrate electronic health information with other sources; and (5) capture and query of information relevant to health care quality.

Note that electronic medical record is often used synonymously with electronic health record. The US Office of the National Coordinator for Health Information Technology (ONC; Washington, DC) and Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) use the term EHR, and we will as well throughout this series of articles.

### Meaningful Use of EHRs

The greatest driver of the increase in EHR implementation (“EHR uptake”) is recent federal action designed to promote its use. The Health Information Technology for Economic and Clinical Health Act,3  or the HITECH Act, a part of the American Recovery and Reinvestment Act of 2009,4  empowered the CMS and the ONC, both offices within the US Department of Health and Human Services (Washington, DC), to develop programs and regulations to promote the use of EHRs by physicians and hospitals.

In July 2010, the CMS and ONC simultaneously released regulations implementing those mandates. The CMS regulations, issued under a Final Rule entitled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program,”5  created the program commonly known as meaningful use (MU). The MU establishes criteria, reporting requirements, incentive payments, and penalties for both eligible providers (individual practitioners) and hospitals, related to their use of EHR technology in patient care. Generally, MU requirements encompass clinical activities like e-prescribing, documenting, and communicating various aspects of the direct, face-to-face patient-care encounters and the reporting of clinical quality measures to the government.

The corresponding “Standards and Certification Criteria for EHR Technology,”6  published by the ONC, describes minimum functional and technical capabilities, standards, and implementation specifications for certified EHR technologies (CEHRT). Health care providers can achieve MU only through the use of CEHRT, and those regulations establish a testing and certification process by which EHR products may demonstrate their ability to support MU. Of particular relevance to pathologists, some laboratory information systems (LISs) are also achieving certification as CEHRT modules, and consequently, they may become part of an organization's MU strategy.

The CMS has signaled its intent to implement a minimum of 3 stages of MU requirements, and the agency released stage 2 requirements in September 2012.7  Each stage of the MU program will introduce additional provider requirements and functional and technical capabilities for CEHRT. In support of MU stage 2 requirements, in September 2012, the ONC published an updated set of EHR standards and certification criteria, known as the 2014 edition.8

## CHALLENGES AND IMPERATIVES FOR PATHOLOGISTS AND LABORATORY INFORMATION MANAGEMENT IN THE EHR ERA

### MU/ONC Requirements Directly Relevant to Laboratories

A detailed discussion of the MU/CEHRT requirements specific to laboratory data is beyond the scope of this article and is thoroughly discussed elsewhere.13  Briefly, the MU stage 2 regulations call for the following:

• Incorporation of more than 55% of yes/no or numerical laboratory results into the EHR as structured data

• Use of computerized provider order entry for at least 30% of laboratory orders

• Electronic transmission of reportable disease diagnoses to public health agencies (using version 2.5.1 standards from Health Level 7 International [HL7], Ann Arbor, Michigan)

• Use of the Logical Observation Identifier Names and Codes (LOINC; Regenstrief Institute, Indianapolis, Indiana)14  vocabulary standard for test code names

• Sending structured electronic laboratory results to ambulatory ordering providers for more than 20% of electronic laboratory orders received (hospital-specific requirement)

Realistically, meeting the first 2 goals requires deployment of LIS-EHR electronic interfaces (see below). In addition, the regulations specify that LIS-EHR interfaces be implemented in accordance with ONC's recently developed “Laboratory Results Interface (LRI) Implementation Guide.”15  An analogous implementation guide of specifications for laboratory orders is in development.16  Among other reasons, these specifications are of particular relevance to laboratories because they require the use of data standards, such as LOINC, HL7 v2.5.1, and SNOMED CT (Systematized Nomenclature of Medicine Clinical Terms; International Health Terminology Standards Development Organisation, Copenhagen, Denmark), and existing LISs and interfaces in some laboratories may require remediation to be compliant.

### LIS Selection in the EHR Era

Laboratories have used computerized information systems for decades,17,18  and a laboratory's ability to deliver patient care operations depends on its LISs.19  Because of the distinct operational requirements of clinical versus anatomic pathology laboratories, separate LIS applications are commonly employed in each setting,20  and other specialized laboratories, such as blood banks, often employ yet a different LIS.21  Because LISs are fundamental to, and tailored for, laboratory operations, laboratories, and to some extent pathologists, have historically had a major role in, or taken full responsibility for, LIS evaluation, selection, and control.2226

Pathologists should realize that the rise of EHRs may change the dynamics (and politics) of LIS selection and control in integrated health care organizations.27  In the EHR era, as organizations look to purchase and implement EHRs, laboratories may find themselves in a situation where their institutions may investigate replacing their existing LIS with an LIS from the same EHR vendor, based on envisioned cost savings and/or improved system-integration benefits. The Association for Pathology Informatics (Chicago, Illinois) has recently released a “LIS Functionality Assessment Toolkit,”28,29  which endeavors to provide structure for the laboratory professional to select the most appropriate LIS product for their needs, ranging from software demonstration scenarios to development of a total cost of ownership statement.

The ability to fulfill all of the responsibilities of a laboratory director may be at risk, if not significantly compromised, by inadequate LIS functionality, regardless of whether the LIS is single-solution or department-specific (so-called best of breed). Given their experience with clinical information management, pathologists are uniquely positioned to provide crucial laboratory domain expertise for an LIS system-selection process when such inadequacies might be identifiable. At a minimum, it is critical to patient care that an LIS selected from any vendor incorporates all of the specialized functionality necessary to meet the laboratory's patient care mission, to preserve patient safety, to meet regulatory requirements, and to support efficient operations.

Issues in LIS selection and oversight in the EHR era are explored in detail in the second article in this series, titled “Stand-alone Laboratory Information Systems Versus Laboratory Modules Incorporated in the Electronic Health Record.” 30

### Issues in Exchanging Laboratory Orders and Results With EHRs

As laboratory clients implement EHRs, their expectations that laboratories will implement—and pay for—LIS-EHR result reporting and order-entry interfaces suited to their EHRs will increase dramatically. Current reporting methods, such as Web portals and paper or fax delivery of laboratory results, will not meet the MU needs of providers and hospitals for seamless integration of laboratory data into their EHRs. In addition, as seen in the CMS and ONC regulations and related programs, laboratories will be expected to share data electronically with EHRs and other systems employed in various settings, such as laboratories, hospitals, physician offices, payers, public health agencies, disease registries, health information exchanges, among others.31,32

Pathologists and laboratories face significant technical, operational, organizational, and financial challenges related to the implementation and support of LIS-EHR interfaces. These challenges have been reviewed recently13,33  and are summarized in the Table. Laboratories that are not prepared to respond quickly to interface requests face the risk of a loss in physician business to other service providers.

Contributions From Pathology During the Selection of an Electronic Health Record (EHR)

Operational issues in LIS-EHR data exchange for both the anatomic and clinical pathology laboratories, as well as several special considerations, are explored further in the third article of this series titled, “Management of Laboratory Data and Information Exchange in the Electronic Health Record.” 34

### Regulatory and Accreditation Effects From EHR Implementation

As noted above, the role of the laboratory director, and the ability of the director to fulfill all the responsibilities of the role, is significantly affected by MU requirements. The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)35  place the responsibility for communication of laboratory data squarely on the director's shoulders, and the ability to satisfy those requirements is hindered by a variety of EHR and result-reporting issues. Because EHRs affect system interoperability, data integrity, and data reporting requirements, the pathologist must be aware of those potential effects on their laboratory accreditation. The DIHIT Committee of the College of American Pathologists (Northfield, Illinois) recently published a list of 10 key issues that must be addressed when implementing an EHR system.36

Regulatory and accreditation concerns in LIS-EHR data exchange are addressed in the fourth article of this series titled “Accreditation and Regulatory Implications of Electronic Health Records for Laboratory Reporting.” 37

### Transformative Roles for the Pathologist as Steward of Laboratory Information

As described above and expanded upon in other articles in this series, the use of EHRs 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 EHRs and throughout health care organizations.

The fifth article in this series, titled “Pathologists as Stewards of Laboratory Information,”38  addresses the nature of the stewardship role, the functional requirements of the role, and strategies that pathologists can employ to be successful in the role. That article makes clear that pathologists must find ways to become actively involved with their administrations, colleagues in pathology and other specialties, and associates across the clinical informatics community to ensure that decisions affecting their practice are made with appropriate input, feedback, and data.

## SUMMARY AND CONCLUSION

Electronic health records are transforming the practice of medicine. Spurred by federal regulations, the use of EHRs continues to grow. Expansion of EHR use has profound repercussions for pathologists and laboratories. A major consequence of that EHR proliferation, for pathologists and laboratories, is an increased expectation for the deployment and support of LIS-EHR interfaces, which includes technical, operational, and financial challenges. The EHRs fundamentally alter the way that clinicians interact with laboratory information, with test-order entry and result-reviewing functions migrating to the EHR. Because EHRs vary in their capabilities in handling laboratory information and because laboratory information management is only one of many processes in the EHRs, there is a risk of problems in laboratory-information handling that can lead to adverse effects for patients and laboratories. Pathologists have an important role in leading their laboratories to meet those challenges.

Despite the challenges, EHRs offer a tremendous opportunity for pathologists to be stewards that protect, advocate for, champion, and optimize the management of patients' laboratory information in the EHR. Pathologists are suited to this transformative professional role by virtue of their domain expertise, experience with electronic information management and LISs, and orientation toward process control. Important to pathologists gaining influence in EHR-related matters will be establishing relationships and credibility with key stakeholders residing outside the laboratory.

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## Author notes

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

## Competing Interests

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.