While Exhibit 1 above focuses on three important stakeholders in lab exchange – ambulatory providers, clinical laboratories, and patients – there are a range of additional stakeholders who are either critical to effective lab exchange or who have a keen interest in facilitating wide‐spread and more effective adoption of lab exchange models. First, at the “nuts and bolts” level, clinicians’ participation in lab exchange is dictated by the EHR application they have selected and this greatly influences how the specific installation participates in lab exchange. Similarly, clinical laboratories’ ability to participate in lab exchange is dictated by their LIS and the vendors that develop and support these systems. In addition, other key stakeholders include public health officials who could derive benefit from systems designed to allow electronic notification of reportable conditions and population‐based surveillance. Additionally, public and private payers and purchasers stand to benefit from increased cost‐effectiveness of care.
It is important to note differences between different types of providers and laboratories. Large national laboratories that provide services to thousands of providers around the nation often consider the development of interfaces and online portals for ordering and results retrieval as “value added” services for their clinician customers. Hospital laboratories, regional laboratories, or specialty reference laboratories that are limited geographically or in terms of the services they provide, however, may not have the incentive or capacity to provide these types of “add‐ons.”
For the last several years, almost all laboratories have been compelled to adapt their information management focus and use laboratory information systems (LIS) to automate the routine steps in the daily workflow, including: test ordering; specimen labeling; analytical interfaces between scientific instruments and information systems; reporting results; quality control; efficiency; productivity management; financial services (billing, inventory, forecasting and analysis); reference testing and regulatory compliance. The extent of LIS adoption and their capabilities vary widely among the laboratories. Each large national, commercial laboratory relies on its LIS to support a range of business functions that may include in‐house portal solutions for providers that support ordering laboratory tests. Smaller laboratories primarily use commercially available LIS systems to meet their business needs. Regardless of laboratory size, its LIS is frequently used to facilitate compliance with regulatory requirements including those derived from the Clinical Laboratory Improvement Act (CLIA). CLIA applies to all clinical laboratories performing the testing of human specimens including small physician office labs.15 Many small physician office labs, however, perform waived tests which are defined as simple laboratory examinations and procedures. These are cleared by the federal government because they employ methodologies that are simple and accurate so that erroneous results would be negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly.16 For Laboratories performing only waived testing, CLIA requirements are reduced to primarily obtaining a CLIA certificate and complying with the requirement to follow manufacturers’ instructions.17 CLIA is described in greater detail below. While some large commercial labs have systems that were developed in house, in recent years a number of large software vendors provide LIS products. The November 2008 College of American Pathologists (CAP) LIS survey results include a self‐reported listing of LIS products.18 According to the CAP LIS survey there are at least 35 different lab information systems that clinical laboratories may purchase from a variety of vendors. Labs may also choose to purchase or implement only specific components of the LIS from these vendors resulting in a tremendous variability in LIS configurations and implementations from one clinical laboratory to the next. In addition, there are important provider differences that are relevant. Larger provider organizations such as integrated delivery systems and multi‐specialty group practices may be, by virtue of their size and level of integration, in a better position to access resources necessary for adopting EHRs and working with vendors and clinical laboratories to establish exchange. Recent surveys show that a distinct minority of ambulatory health care settings are using EHRs. An even smaller percentage use EHRs that interface with their clinical laboratories’ LIS. An average provider’s office today interfaces with two labs and may also have the capacity to do some lab work itself. Health centers and other safety net providers have relatively little access to resources necessary to achieve exchange except to a limited extent in the context of health center networks. While networks have been demonstrated to be an important vehicle for helping health centers adopt health IT, they are also another stakeholder in the exchange of laboratory information, in addition to EHR vendors, clinical laboratories and the providers themselves.
The next two sections of this paper describe implementation issues associated with lab interfaces including key processes, decisions and use of standards. While these issues affect all providers regardless of the nature of the provider organization involved, we note there are important differences in the abilities of different types of providers to secure the expertise and resources to address these requirements.