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Statement of

The American Clinical Laboratory Association


The National Committee on Vital and Health Statistics

Hearing on Functional Requirements for the National Health Information Network

Jason DuBois, Vice President

July 27, 2006

The Nationwide Health Information Network’s use case (lab results) and broader electronic health record needs

Statement of

The American Clinical Laboratory Association


The National Committee on Vital and Health Statistics

July 27, 2006

Jason DuBois, Vice President, Government Relations

Dr. Cohn, Committee members, thank you for the opportunity to testify today on behalf of the American Clinical Laboratory Association (ACLA), which represents national, regional, and local laboratories.  My name is Jason DuBois, Vice President of Government Relations for ACLA, and I appreciate your interest in the Nationwide Health Information Network’s (NHIN) use case (lab results) and broader electronic health record needs.  ACLA members have an extensive history of providing the nation’s hospitals and physicians with leading-edge health information technology (IT) to streamline the laboratory test requisition process and speed the delivery of test results.

Today, I would like to focus on four specific issues that are pertinent both to the NHIN’s use case of lab results as well as to broader electronic health record (EHR) needs.  These are:  (1) clinical data standards for laboratory results reporting and test requisition; (2) identity/information correlation (i.e., a unique patient identifier); (3) the cost to large data providers of servicing a national population; and (4) authorization as it relates to the Clinical Laboratory Information Amendments of 1988 (CLIA).

However, before delving into these issues, I must note that as we discuss the functional requirements that will frame the development of the NHIN, part of the difficulty in making recommendations is the relative uncertainty of the architecture for such a system – i.e., are data going to be pushed or pulled; will information be centralized or decentralized.  The answers to these questions will ultimately determine the framework and, in turn, determine what specific issues laboratories will encounter in sending and receiving information through the NHIN.  For example, authentication of the requester of data becomes a problem for laboratories if the architecture of the NHIN is such that information resides with the originator of the data (e.g., a laboratory), as is the case with the Utah Health Information Network (UHIN).  In this scenario, providers request UHIN to query all providers within the network for any information regarding a patient.  Regardless of the architecture that is ultimately established, laboratories have several issues with respect to the proposed NHIN functional categories that must be addressed for these efforts to be successful.

Clinical data standards for laboratory results

First, I’d like to address the need for uniform clinical data standards for laboratory test requisition and result reporting, and describe an effort currently underway within the laboratory community.  The creation and adoption of a national standard for test requisition and results reporting will simplify the use of electronic health records systems.  Such a standard will help physician practices reap tangible benefits early in EHR implementation and reduce costs associated with EHR system installation and configuration.  In addition, a national standard will reduce the cost and effort currently required to implement custom interfaces between independent laboratories and ambulatory EHR systems.  Likewise, a national standard will also significantly expand the set of ambulatory EHR implementations that include reporting of electronic laboratory results and test requisitions.  Finally, a national standard will also enhance the utility of electronic laboratory result data by specifying structural and coding standards that enable greater automated processing, including decision support, quality measurement, and regional sharing.  Ultimately, these outcomes will enhance the viability and functionality of the NHIN.

An implementation guide that will serve as the foundation for just such a uniform national standard is the EHR-Lab Interoperability and Connectivity Standards (ELINCS) project.  Currently managed by the California Healthcare Foundation, the ELINCS project represents the concerted efforts of laboratories, IT vendors, government agencies, physician groups and many others.  The implementation guide is currently under review with the Health Information Technology Standards Panel (HITSP).  While the California Healthcare Foundation is not a standards development organization (SDO), efforts are underway to transfer ELINCS to an SDO that is a non-proprietary, consensus driven organization.  Our association and its members, as well as all of those who participated in the project, have spent a considerable amount of time helping to devise this standard and it is our hope that it will ultimately be relied upon as the means for uniform result reporting and laboratory test requisitions.

In addition, ACLA makes the following recommendations regarding interoperability standards:

  • A particular HL7 version (i.e., HL7 Version 2.3 or a higher version) should be adopted for use in the NHIN, together with an implementation guide for that version;
  • LOINC should be used in the NHIN once an implementation guide is developed;
  • The adoption of either SNOMED-CT or ICD-10 to replace ICD-9 will require a massive reprogramming effort, but one or the other should be selected for use in the NHIN when the HIPAA Transaction and Code Set standards are revised accordingly.

Furthermore, to facilitate widespread participation, the NHIN should build upon existing standards that are already commonplace in the industry instead of imposing new standards from the top down.  Accordingly, whatever standards are adopted should be consistent with the HIPAA Transaction and Code Set standards, and should take into account any other standards that are currently being employed in the health care industry.

Identity/information correlation

Another issue which ACLA believes needs to be resolved is that of a patient identification strategy.  The most effective patient identification strategy would be a unique patient identifier.  However, we recognize that the goal of patient safety through rigorous patient identification must be balanced with privacy concerns, so if a unique patient identifier continues to be politically unacceptable, at a minimum the NHIN must adopt a robust, uniform national algorithm for patient matching using a standard minimum data set, recognizing that no such algorithm is perfect and that many records simply will never match due to patient name changes, nicknames, initials, misspellings, marriages, divorces, and changes of address.

Laboratories face unique challenges in this area because they typically do not see the patient and do not control the data acquisition.  Certain data elements, such as patient address, date of birth, or even gender may not be required for certain billing arrangements.  Therefore, any data set that is employed should not include data elements that providers such as clinical laboratories do not typically have access to; otherwise, the system will only further reduce the odds that records will match.  The patient identification function is one of the most basic foundations of the NHIN concept, and the difficulties associated with a complete matching system must be resolved before the NHIN infrastructure can be completed.


While not a specific functional category, cost is certainly an issue that must be considered when developing the functional categories for the NHIN.  Laboratories and other large data providers face a potentially costly burden because of the depth and breadth of servicing a national population, and the resulting expectation of the availability of data and responsiveness with which data are sent.  The requirement of certain functional criteria could translate into tremendous costs for laboratories and other large data providers within the NHIN.  Examples abound; however, I will list a few of these potential requirements, which could translate into direct costs for laboratories:

  • Creating audit trails and conducting regular risk assessments
  • Providing patients with a mechanism to indicate that a visit is confidential and hence only the ordering clinician is to be notified
  • Supporting entry and display of content in language specified by user
  • Presenting data via a web portal immediately upon availability of result

If adopted as “standards” within the NHIN, these criteria, while well-intended, will drive up the costs of transmitting and/or storing data for laboratories and other large data providers such as pharmaceutical or imaging providers.


The final issue ACLA would like to raise before the Committee is the NHIN functional category of authorization.  Within the category of authorization, laboratories face two problems: (1) their liability for the transmission of laboratory results each time they are delivered to another entity within the NHIN; and (2) ensuring that an authenticated requester is authorized to view the data – i.e., is this a permitted disclosure and is the extent of the request reasonable.

Pursuant to CLIA, when test result report information is disclosed by the physician to a regional health information organization (RHIO), the clinical laboratory is still responsible for the content and format of that report.  In addition, when an EHR vendor changes the test result report that is provided to the physician, the clinical laboratory is still responsible for the content and format of that report, in accordance with CLIA requirements.  Taking this one step further, laboratories would then be responsible for test result report information in the NHIN, despite the potential for reports to be modified several times over for each and every manipulation made to them when an EHR vendor modifies the content, and for each and every time the content was used (e.g., primary care visit, office visit to a specialist, hospital admission, nursing home stay, etc.).  This regulatory burden needs to be addressed in order to facilitate the exchange of electronic health data for treatment purposes.

ACLA has proposals to address both situations.  In order to address the issue of EHR vendors modifying laboratory result report content, we propose two potential solutions:  (1) amend the CLIA Interpretive Guidelines to clarify that the laboratory must only ensure that the CLIA-compliant report is received by either the client or the vendor (or other contractually obligated intermediary) system; or (2) seek amendment of the CLIA regulations (42 CFR §493.1291(a)) to clarify that the results may be sent either to the client or to the intermediary.

Second, to address the issue of information shared with other health care providers aside from the ordering physician, the clinical laboratory’s responsibility for the test result should end once the result is provided to the ordering physician or other vendor.  The Interpretive Guidelines should make clear that the laboratory is not responsible for subsequent disclosure of test result information made by the physician.

The other issue within the NHIN functional category of authorization presents a particular problem for laboratories given their indirect provider status.  Developing a strong authentication and authorization infrastructure is paramount to ensuring the privacy and confidentiality of patients whose information is part of the NHIN.  The authorization infrastructure would need to provide an architecture governing the release of protected health information (PHI) for purposes for which patient authorization is required (e.g., marketing).  This authorization infrastructure would need to accommodate the indirect provider status of clinical laboratories.  Without this mechanism, laboratories, in addition to other legitimate entities, would have no way of knowing whether requests for PHI are lawful, and if so, the extent to which the release of the information is a permitted use.  Any authorization infrastructure would need to be integrated so that user credentials could be evaluated against the information being requested and the authorizations associated with the patient.

In conclusion, ACLA believes the issues discussed in this statement – namely clinical data standards for laboratory test requisition and result reporting; a unique patient identifier; the cost to large data providers of servicing a national population; and the need for changes to existing CLIA regulations as well as the creation of an authorization infrastructure – are necessary to facilitate the transmission of laboratory results as well as to address broader electronic health record needs in the NHIN.

The questions being asked today are important to the development of a fully functional National Health Information Network that, while providing for the transmission of pertinent patient information for quality care, also addresses the security and privacy needs required for any system that aims to encompass the entire nation.