November 2007 Clinical Laboratory News: The Groundwork for the National Electronic Health Record System

November 2007: Volume 33, Number 11

The Groundwork for the National Electronic Health Record System
What Pitfalls Lie Ahead as Test Results Go Digital?

By Julie McDowell 

President Bush’s national health information technology (IT) agenda calls for most Americans to have access to secure electronic health records (EHRs) by 2014. The primary catalyst for reaching this goal is the Department of Health and Human Services’ (HHS) American Health Information Community (AHIC), a federal advisory committee established in 2005 that is now transitioning from a government entity into a public-private partnership. While AHIC’s successor organization, known as ASO, will no longer be a purely federal initiative, officials have emphasized that it will be the primary U.S. organization leading the integration and use of a standards-based, interoperable health IT system in which medical information is both protected and portable. At the same time, the Centers for Medicare & Medicaid Services (CMS) has announced plans to launch a pilot project to offer Medicare beneficiaries an Internet-based personal health record (PHR), which is viewed by agency officials as an important tool when used in conjunction with EHRs.

But while federal officials have made it clear that laboratory results are a key component in EHRs and PHRs, many clinical laboratorians are critical of these efforts because there has been little to no representation from the laboratory community. Citing complexities associated with data transmission and compliance with federal regulations under CLIA, many industry leaders believe that the nuances of pulling testing data into EHRs will only be reflected in future health IT standards if laboratorians are represented in the ASO and other federal initiatives.

Laying the Groundwork for a National Technology Plan

Shortly after President Bush announced his Health Information Technology Plan, federal officials created AHIC, placing it under the management of the Office of the National Coordinator for Health Information Technology (ONC) in 2005. AHIC is comprised of 16 primary members representing various healthcare sectors. “When the current AHIC was being developed, we said that someone from the clinical laboratory field needed to be part of this effort, because a significant portion of the electronic health record is laboratory data,” said Jason DuBois, Vice President for Government Relations at the American Clinical Laboratory Association (ACLA). But to the dismay of many in the clinical laboratory community, federal officials ignored requests for this representation. Instead, medical testing services were represented as “ancillary services”, which also includes pharmacy services.

Over the past two years, AHIC’s role has been primarily to identify issues and priorities associated with advancing a national IT agenda. This includes awarding several contracts to carry out identified priorities. In addition, one of AHIC’s accomplishments was a set of recommendations in four key areas that were delivered to HHS Secretary Michael Leavitt in May 2006 (see Box, below). But as the AHIC charter mandates, the group must now transition into a public-private partnership rooted within the private sector, now known as the ASO. In August, the ONC released a white paper on the AHIC Successor for public comment, asking for feedback on plans to transition the committee to the ASO, which is expected in Fall 2008. This white paper includes three potential models of the ASO’s organizational design.


The National IT Agenda
Defining the Future

The Office of the National Coordinator for Health Information Technology (ONC) and the American Health Information Community (AHIC) were established in 2005. In May 2006, AHIC delivered their initial set of IT-related recommendations and goals in four key work group areas.

  • Consumer Empowerment: Create a consumer-directed and secure electronic healthcare registration information and medication history for patients.
  • Chronic Care: Use secure messaging, such as email, for communication between patients and their healthcare providers.
  • Electronic Health Records (EHRs): Create standardized, secure records of past and current laboratory test results that are accessible by health professionals.
  • Bio-surveillance: Enable the transfer of standardized and anonymized health data to authorized public health agencies within 24 hours.

    In addition to these recommendations, AHIC has awarded several contracts over the past 2 years to vendors to carry out President Bush’s national IT agenda. One of these contracts was awarded to the American National Standards Institute (ANSI) to create the Health Information Technology Standards Panel (HITSP), which is focused on harmonizing industry-wide health IT standards. Moving forward, AHIC is transitioning into a public-private partnership, which federal officials have called the AHIC Successor Organization (ASO). Additional information is available on the AHIC Web site.


In their comments on the ASO white paper, both ACLA and College of American Pathologists (CAP) officials implored the ONC to offer an ASO seat to a representative from the clinical laboratory community. One idea presented in this proposal is that the ASO should be made up of membership sectors representing healthcare stakeholders, including clinicians, consumers, employers/purchasers, and one sector for pharmaceuticals and devices. CAP President Thomas M. Sodeman, MD, FCAP, called for the ASO to have a clinical laboratory membership sector to represent laboratory and pathology services. “Creating a separate membership sector for clinical laboratories, like that proposed for pharmaceuticals and devices, would ensure that the vital perspective of pathology and laboratory medicine is incorporated in the AHIC successor,” he wrote in a letter submitted to the ONC. “Importantly, such a sector would permit, through participating membership, an interface with other physicians and the healthcare entities for which pathologists interpret laboratory results.”

Whatever form this AHIC successor organization takes, it’s vital that laboratorians play a role in not only its design, but also its operation, according to ACLA President Alan Mertz’s response to the ONC. “With 60% of data in medical records derived from laboratory test results, every community that is trying to launch some health information infrastructure is looking at laboratories as the first element they need,” he wrote. “Further, many of the issues associated with laboratories and laboratory data are unique, and those unfamiliar with the esoteric intricacies of these issues are ill equipped to represent or address them.”

Making EHRs CLIA Compliant

In addition to the commencement of the ASO, there are concerns about other current federal health IT initiatives and the direction they are moving in. One effort causing alarm is the Healthcare Information Technology Standards Panel (HITSP), a coordinating body tasked by the ONC to identify technical standards necessary for healthcare data interoperability. Formed in 2005, HITSP is administered by the American National Standards Institute as part of a contract with the ONC. HITSP’s main efforts include developing standardized lab result reporting specifications, including those based on the Unified Code for Units of Measure (UCUM). “The nomenclature that they are developing based on UCUM is not something that labs are using today and few, if any, hospitals are, but despite that, HITSP is looking to include that in their work,” said ACLA’s DuBois. “One of our concerns is that they are leveraging standards and nomenclature that is not widely adopted today or is likely to be used in the near future.”

While standardization is in the best interest of everyone, he added, it’s important for federal officials to realize that not everyone is currently using health IT. “There are many physicians and hospitals that are still faxing results and writing prescriptions and test orders,” said DuBois. “These federal efforts should do more to get adoption of health IT before they impose standards and nomenclature on the 20% of facilities who have already adopted this technology. In addition, we don’t want to penalize the people who have invested the capital expenditure to introduce health IT into their systems by giving them new requirements or impediments.”

The movement of IT into the healthcare sector also brings with it the presence of vendors such as GE Healthcare (Fairfield, Conn.) and Siemens (Berlin and Munich, Germany). Through billions of dollars in government contracts, these corporate IT leaders will continue to design the architecture of EHR systems. No doubt Siemens, the German giant that recently acquired several diagnostic companies, has its sights set on the lab sector of this market and integrating test results into EHRs. But if these EHR systems do not take into account CLIA regulations, there will likely be problems for labs, according to Judy Yost, Director of CMS’s Division of Laboratory Services. “What I don’t think people realize is that at some point these systems will bump up against CLIA, because it’s not always a straight shot sending a result from a laboratory directly to the authorized person who ordered the test, which is what CLIA requires,” she explained. “What happens with electronic health records is that in many cases, they go to other types of data repositories prior to traveling to the authorized person—it’s not necessarily a straight shot. One of the key problems is that all of the vendors must be CLIA compliant and they are not always compatible with each other. It wouldn’t be a CLIA issue if this wasn’t a problem, but vendors and their systems are not standardized and they may not have any real desire to be standardized.”


Microsoft Launches Consumer-focused PHR System

Consumers with an Internet connection will soon be able to take charge of their own electronic health records if computer industry giant Microsoft (Seattle, Wash.) has its way. In early October, the company rolled out HealthVault, a free Web-based health information storage and communication system built in partnership with healthcare institutions such as the Coalition for Patient Privacy, American Diabetes Association, American Heart Association, American Stroke Association, and LifeScan (Milpitas, Calif.).

Microsoft designed HealthVault with a “connection center” so that consumers can pull their health information together themselves by uploading and storing personal data from healthcare providers, devices, and services built or modified to work on the HealthVault platform. So far, more than 40 organizations have committed to developing applications or services that will be HealthVault-compatible. As of the October launch, the providers NewYork-Presbyterian Hospital (New York, N.Y.) and MedStar Health (Columbia, Md.) both offer lab and other health information sent directly to HealthVault accounts.

The HealthVault Web site also features a special search engine that organizes Web results from trusted sources alongside more general Web results.

“People are concerned to find themselves at the center of the healthcare ecosystem today because they must navigate a complex web of disconnected interactions between providers, hospitals, insurance companies, and even government agencies,” said Peter Neupert, corporate vice president of the Microsoft Health Solutions Group in a press release. “The launch of HealthVault makes it possible for people to collect their private health information on their own terms, and for companies across the health industry to deliver compatible tools and services built on the HealthVault platform.”


To address these concerns, Yost has been working to educate HHS officials about CLIA regulations, as well as how to work with CMS’s legal counsel to maintain the quality of lab testing without presenting an undue burden for vendors and laboratorians. “The process of checking data and information as it goes through various steps and intermediaries before it reaches the authorized person is the issue that causes heartburn, because it appears as if we’re at a roadblock,” she explained. “We want to maintain the integrity of CLIA and ensure quality in test reporting while not holding labs accountable for something they have no authority over. We are trying to come up with some solutions to accomplish this, such as through policies where there would be an accrediting organization for certifying intermediary vendors to ensure that someone was checking to verify that what the labs and physicians are receiving and sending is accurate, reliable, timely, and confidential.”

Yost’s discussions with HHS officials often include envisioning scenarios where laboratories might run into problems with transmitting results and updating EHRs. “For example, a specialist physician might want to send a patient’s results to another specialist or other caregiver, or primary physician,” she explained. However, this raises consent and privacy issues, especially if the patient doesn’t want his primary doctor seeing these results. “Everything is intertwined, and it’s been very complicated to work through,” she added. “We’ve been coming up with scenarios to see what works and doesn’t work and where the road blocks might be, and what we can do to mitigate them, but it’s still an ongoing project.”

Preparing for Electronic Records

For laboratorians who want to prepare now as the national movement towards EHRs gathers speed, Yost recommends looking at the obstacles encountered by others in the laboratory medicine industry that have launched EHRs. It’s also important to consider how patients interact with EHRs and PHRs. CMS is interested in this angle, and in June announced that it will launch an 18-month pilot project offering Medicare beneficiaries an Internet-based PHR. Four organizations are participating in this project: Health Insurance Plan of Greater New York (New York, N.Y.), Humana (Green Bay, Wis.), Kaiser Permanente (Oakland, Calif.), and the University of Pittsburgh Medical Center in Pennsylvania.

Of these four participants, Kaiser Permanente is the only organization whose PHR could potentially feature both claims and clinical data. The lab component of the PHR was originally introduced to Hawaii Kaiser members in September 2005, with roll-outs then following in every region. With 1.6 million registered users, over 9 million lab tests have been viewed online, according to Jan Oldenburg, a practice leader with the Kaiser Permanente Internet Services Group in Oakland, Calif.

Under Kaiser Permanente’s current system, a patient’s lab data initially goes into Kaiser Permanente HealthConnect, their system-wide EHR. The PHR then pulls the data from the system to show members slices of their clinical data online, including lab test results. After the results are posted, the patient receives an e-mail with a link to the sign-in screen. Patients must then log in to be taken to the PHR’s summary screen, which lists the tests that have been released. Each test links to a detail screen with actual results, references ranges, and in some cases, physician comments. “If the result is outside of the reference range, there is a flag,” explained Oldenburg. “Then there is text explaining how to interpret the flag.” Patients are also able to link to a health encyclopedia that provides additional information on the test, what it’s diagnosing, and what normal and abnormal results mean. Members also have a link telling them how to contact physicians by phone or e-mail. “One of our fears was that the number of contacts by members to doctors would be really high after they saw their lab results,” she added. “But that has not turned out to be the case.”

AACC LIS Division Seeks Input

AACC’s Laboratory Information Systems and Medical Informatics (LISMI) Division works to tackle issues related to not only LIS, but also to EHRs and interoperability. LISMI Division members are currently seeking comments on a variety of questions ranging from how testing data should flow between laboratorians and clinicians and appropriate testing data structures to support EHRs. These comments are used to plan educational programs offered by the LISMI Division, as well as those offered jointly with other AACC divisions. These questions as well as additional information can be found on the Division’s Web site.


When and How to Release Results

When Oldenburg and her colleagues began designing the lab test results feature for Kaiser’s PHR, a team of physicians led by the Web site medical director initially focused on what test results should be accessible online to members. “Our focus has always been to show members the same information that the doctors see,” said Oldenburg. “With lab results, however, some tricky issues emerge. We want to be transparent to members, which means that anything we can show our members we want to show our members. But that was problematic for a number of reasons. We had to consider how abnormal lab results would figure into the clinical work flow. For example, how would testing data operate in the work flow if members saw abnormal results before their physicians?”

There were also lots of questions about what Kaiser Permanente could legally post online. Some states have regulations over privacy and confidentiality that prevent certain health information from being released electronically. “For example, in California, we are prohibited from showing members online test results that may show cancer, HIV, and hepatitis test results,” explained Oldenburg. “Our physicians committee went through over 7,000 tests and recommended whether results of these tests should be released and if so, under what circumstances. Each region decides how to interpret the recommendations, so lab results release may vary a bit by region.”

Also in question was how results would be released. Depending on the test and whether the result was abnormal or normal, clinical and legal teams in each region had to decide which results should be auto-released—posted without being viewed by the physicians—and which results should be released manually by physicians or on time delay, meaning they would automatically release following a regionally-specified time period. They also analyzed what results should be suppressed completely. “Most regions didn’t release many abnormal test results in the early stages—we tended to be very cautious and decided to release many of the results on time delay to make sure that the physician saw the results first,” said Oldenburg. “But, led by the teams in Georgia and our Mid Atlantic states’ regions, we soon discovered that our members just really wanted to see their labs, as fast as possible, and as many labs as possible. In addition, we found that in every region, physicians became more comfortable releasing more labs, releasing them sooner, and releasing them even if they were abnormal, and in some cases even before the physicians had seen them.”

Looking forward, Kaiser Permanente is focusing on the portability and interoperability of the PHR to determine what clinical data should be available to members when they leave the health plan or if the PHR data can be transmitted to another EHR system. “We’re in the early days of this,” Oldenburg explained. “Our first step has been to create a PDF of the PHR’s summary materials, which we hope to release next year. We are also working closely with the standards organizations to figure out how to transfer data from one PHR to another PHR or EHR.” They are also working to integrate both claims data from contracted providers and more member-entered data.

As both federal officials and other healthcare providers move forward and begin building a national EHR system, Oldenburg emphasized the key role that laboratory results play in electronic health data delivery, particularly because consumers are demanding to see their results sooner, rather than later. “Getting lab results online after a patient has already received a letter in the mail is not nearly as useful as posting it online the day after the test was performed,” she explained. “It’s important that we find a way to get the results out there in the most granular way possible, and in a way that provides context, so the patients are not getting a result that they don’t understand. The result should be surrounded by some teaching opportunities so that they can understand what action they might need to take to better manage their health.”



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