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Accenture

In the grand scheme of patient care, laboratories do far more than just receive orders and return results.They aggregate and provide fundamental information upon which clinicians base critical decisions.

Throughout the care continuum, laboratory services provide test results and interpretations that drive and affect medical decisions as well as billing and other business matters. In a world of centralized and decentralized laboratory models, many and disparate pieces of information about the same patient reside in different systems and different places. Additionally, this information is not uniform from system to system.

How does one integrate these systems with EHR so that all information — from the most basic blood chemistry results to the most complicated biopsy interpretations — can be aggregated, accessed and consumed by clinicians and other decision makers in a meaningful way? And how can EHR extend the functionality of laboratory systems as a broker of information between organizations and individuals?

What Do Labs Do?

Laboratory systems provide test results for patient samples. The scope of the typical laboratory includes clinical and anatomic pathology. Consequently, laboratory systems capture information such as patient demographics and order information. They also generate a broad range of result data including numeric, textual and derived or calculated data. Interpretations of clinical data by laboratory clinicians are a subset of this information. In the laboratory setting, information crosses all of the care venues (primary care, acute care, post-acute care, home care, the emergency department and ambulatory settings) and may include clinical trial environments. Information is received and transmitted in various ways, from automated, integrated systems to standalone systems with no electronic interface.

Labs receive primary information about patient demographics from client registries, provider registries and master patient indexes. The lab system must rationalize information complexities and correct information disparities to ensure it performs the right test for, and routes results about, the right patient to the right individuals and organizations. For example, multiple physicians (including the primary care physician) must be able to receive results when conditions dictate. Further complicating matters, the laboratory must track how to route results to the various recipients.

Laboratory information systems capture test orders, such as:

• Test codes and descriptions;
• The date and time a test should be performed or samples collected;
• Test conditions;
• Provider(s) involved;
• Result instructions; and
• Test status (whether routine or immediate, for example).

Essentially this equates to what to do, when and how to do it and who needs the results.Many labs do not standardize the codes for describing test codes beyond the common procedure terminology (CPT) convention. Nomenclature for test codes and descriptions varies, even when translated over a standardized HL7 data stream. This complicates the ability to share laboratory data in a way that enables a cumulative view of the data (when result codes are not uniform). A clinician wishing to view a patient’s hemoglobin, for example,may have difficulty rationalizing the result if three different labs describe and code that test as “HGB,” “Hemoglobin,” and the hemoglobin component of an “H&H.”

Results information encompasses the actual test result, including the method used and associated reference ranges, and the specimen type and parameters for its collection. The LOINC nomenclature (Logical Observations Identifiers Names and Codes) has attempted to rationalize and standardize ordering and results nomenclature.While this method is highly effective for a broad range of laboratory testing, deficiencies exist in areas such as microbiology, anatomic pathology and cytology.

Laboratory systems also contain derived data from accumulating results over time. As with orders, internal and idiosyncratic nomenclature makes it difficult to pool and exchange results.

Benefits and Risks of Transcending Paper

EHR integration offers multiple benefits over paper for record capture, storage and transmission. It permits multiple viewers to obtain multiple views of data, building collaboration between and among organizations and individuals.

Folding laboratories into the EHR system permits rapid inquiry into the status of orders and results. It also enables linkages to decision support engines so that laboratory data drive actions and interventions. For example, the system can incorporate alerts based on any lab value outside of acceptable ranges or to indicate potential contraindications of a medication order for a patient based on a specific result of a laboratory procedure for that patient.

Another benefit of EHR is the aggregation of data, representing a centralized and rational approach, thus reducing unnecessary testing, with a concomitant reduction in costs. It improves storage and tracking of specimens, reducing the incidence of repeat testing, which is costly and often incurs patient inconvenience or discomfort.

Finally, EHR presents significant opportunities for standardization of nomenclature and processes. Creating an electronic perspective naturally fuels agreement on standards for naming and describing tests and results.

On the downside, the EHR approach includes some risks for laboratories and their “customers,” such as loss of data or lack of accessibility at critical times if electronic systems fail. This concern can be mitigated with appropriate technology, ensuring near fault tolerance. Additionally implementation depends on all pertinent organizations and users accepting and adopting the technology, including standard data and approaches. In a time when idiosyncrasies are still the norm, this presents certain political and organizational challenges.

Fully electronic approaches also require a different view of security. Access to paper records is inherently difficult and insecure, whereas electronic systems ease access but can be vulnerable to inappropriate disclosure. Systems containing patient health information must incorporate appropriate technology to ensure security and limit access to appropriate members of the healthcare delivery team. The ability to restrict and audit access down to the data element level is becoming required.

Where Things Stand

From an organizational perspective, laboratories tend to be progressive in terms of data integration and systems change, so they offer a natural place to start. The kind of data common to this environment, for the most part, accommodates standardization and interoperability.

Fundamental development in this area has focused on creating a clinical data repository (CDR) standard that will allow cohesive and coherent description and storage of results. Many organizations already hold data and interpretations in a precursor of the CDR, but the end result must accommodate clinical documentation and multiple viewer access from the “vaults” of information.

The diagnostic services industry is a competitive one, with a variety of companies trying to differentiate themselves in the marketplace in order to maintain and grow their customer bases. Laboratory results rank as among the top two or three pieces of information that caregivers demand in order to make appropriate decisions regarding their patient care. One popular strategy by diagnostic companies focuses on providing physicians with tools and systems. In the hospital setting, providers with existing infrastructures want to extend their value by doing more testing and competing with stand alone diagnostic services. (For the most part, both have focused on results delivery, although some have created Web-based order entry.)

All of these strategies will have an ongoing impact on the kinds of systems and technologies adopted for EHR. Hospital providers, for example, have become creative with third-party vendors, using Web portals to deliver results to physician office computers, pagers and other equipment. Naturally this technology must be balanced with the potential overload of information that could result from laboratory results.

Use of Web portals will continue to grow as trends change from viewing relationships as technical to seeing them as servicebased. Laboratories will extend the value of existing systems and become important partners with clinicians by using upcoming technologies to provide remote specimen tracking; proactive, profile-based data reporting; and other customer relationship management features.

Web portals hold great promise, but fragmentation poses considerable challenges. Various organizations and their departments hold separate silos of data. In order to access this information, several methods can be leveraged. One option involves consuming all data and placing them in a master database, then providing access to the database through the Web. Another places an umbrella of Web-based technology over all systems, allowing physicians to consume data in a standard format through controlled access, as and when it is needed.

Challenges to Implementation

Creating standards for messaging, common terminology and results must occur in order to meaningfully integrate laboratory systems with EHR.

The HL7 standard continues to be a “moving target,” with continual version updates that incorporate more capabilities and require retooling of interfaces. In addition, different interface engines can format and inject information into the HL7 data stream, making it relatively easy to modify data to fit specific systems. Although most laboratories use HL7 to send their results, most currently identify tests with their own codes. As a result, receiving systems cannot recognize and file results unless they adopt the same codes, an impractical solution for those using multiple laboratories, or match each laboratory’s code with their own codes, a costly and time-consuming process. Using the LOINC (universal identifiers for laboratory and other clinical observations) solves some of this problem but has limitations with free-text reporting, such as commentary that has an impact on interpreting results.

Creating common terminology presents the same kind of challenges, and not just with test codes. Reference ranges vary from method to method, lab to lab and region to region. Results differ depending on source such as primarily numeric values for chemistry, alpha-numeric for hematology and microbiology and text-based for anatomic pathology. EHR must accept and properly interpret all of these diverse data.

Modifying results in a real-time environment adds further complexity. When technical difficulties occur, EHR must be able to accept the modified results (while maintaining the original results) and produce modified results that explain the differences in values.

Progress is being made in creating systems that can communicate or receive results in diverse environments and interface with decision support engines, so that clinicians can mine data, for example. However, the ability to define federated data or rationalize laboratory testing over the continuum from diverse entities is still a challenge.

Where It’s Working: A Case Study

PACLAB Network Laboratories, based in Bellevue,Washington, has implemented a Web-based portal to improve its position in this competitive business.

PACLAB serves physicians, clinics and large hospitals throughout Washington state (about 30 percent of all outpatient medical laboratory services in the western part of the state, including the Seattle metropolitan area). Its solution provides a consolidated and comprehensive view of a patient’s lab results and medical records to participating physicians and hospitals within their own organizations or from Pathology Associates Medical Laboratories, the primary esoteric lab for, and managing partner of, the PACLAB network.

Previously, hospitals and physicians participating in the PACLAB network experienced difficulties receiving lab reports and an inability to know for certain whether or when patients had tests performed in other healthcare facilities. They also incurred unnecessary costs associated with overlapping or redundant testing.

PACLAB sought an integrated system that would provide realtime access to clinical inpatient and outpatient lab records across multiple organizations. It chose a Microsoft .NET-connected solution called LabsNow, which uses Web services to query systems for lab results and present them in a unified way. Physicians can access the portal through a secure website, or hospitals or clinics can integrate the solution into their own systems to provide their physicians with an in-house portal.

This approach overcame the inherent problem of delays in receiving paper-based lab reports, which increase the risks of misdiagnosis or mistreatment, exacerbate inefficient reimbursement processes and create duplicate testing and added costs. Physicians now go through one channel to build a real-time view of all tests from disparate systems, including mainframes, desktop computers and other systems.

LabsNow also removed concerns about loss of control over patient data. Hospitals, clinics and physicians maintain control over their own data but provide full access to those data when needed elsewhere. The LabsNow solution also allows participating organizations to leverage the resources of others, so that they can offer and charge for additional services without developing their own capabilities. The solution also provides secure methods for transmitting information and is HIPAA compliant. Participating members own their data and choose which information to share.

The Bottom Line