News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Because they provide medical lab test results to EHRs, clinical labs and pathologists are often named in medical malpractice lawsuits

Some experts predict that the great expansion in the number of physicians using electronic health record (EHR) systems may trigger an increase in medical malpractice lawsuits. Were this were to happen, clinical laboratories and pathology group practices might find themselves also named in such lawsuits because they provided the medical laboratory test results that populated the patient’s EHR.

Concern about an increase in medical malpractice claims surfaced in response to the speed at which the federal government is pushing physicians to implement and use electronic health record (EHR) systems as required under the 2009 American Recovery and Reinvestment Act (ARRA). For example, federal officials are directing hospitals to implement EHRs that fulfill the Act’s Meaningful Use (MU) requirements by 2012.

In turn, such a compressed implementation timeline sparks questions about potential liability risks, particularly for physicians. To meet these deadlines, some EHR vendors may be rushing their EHR systems to market before fine-tuning all the functions performed by the software. Because EHRs must accurately capture patient data, any “rush to implement” could mean that the software may have glitches in specific clinical functions that could play a role in malpractice actions filed by patients’ lawyers.

EHR Certification Does Not Address Possible Medico-Legal Issues

The problem of “less than perfect” EHR products is potentially huge, as described by Mark R. Anderson, FHIMSS, CPHIMS, CEO of AC Group, Inc., and Larry Ozeran, M.D., President, Clinical Informatics, in a white paper titled “Do EHRs Increase Liability?” they recently published.

The authors pointed out that several hundred vendors sell a unique EHR product in the United States. There may be as many as 500 EHR products that require certification from the Office of the National Coordinator for Health Information (ONCHI). However, observed Anderson and Ozeran, this certification does not necessarily address existing or potential EHR medico-legal issues.

In the white paper titled “Do EHRs Increase Liability?”, authors Mark Anderson and Larry Ozeran, M.D., describe identify several reasons why poorly-engineered EHR products and increased physician use of EHR systems has the potential to trigger an increased number of medical malpractice claims. (photo copyright

In the white paper titled “Do EHRs Increase Liability?”, authors Mark Anderson and Larry Ozeran, M.D., describe identify several reasons why poorly-engineered EHR products and increased physician use of EHR systems has the potential to trigger an increased number of medical malpractice claims. (photo copyright

This white paper described the potential problem as follows: “In 2010, a report by Conning Research and Consulting2 found that the increased adoption of EHRs by hospitals and medical practices may indeed drive up the cost of medical liability insurance, at least in the early EHR adoption phase. The researchers at Conning believed that documentation errors and the EHR software design will drive up medical liability claims and the cost of defending them, thus driving up the cost of medical liability insurance. According to the 2010 report, even though more than 50% of the medical practices had purchased an EHR, 90% of both hospitals and medical practices had not yet implemented EHRs that met federal meaningful use standards.”

Anderson and Ozeran further went one to describe another issue associated with the expanded use of EHRs that could increase medical liability exposure. They wrote that, “As EHRs become the norm, EHR metadata could present a new legal risk. Unlike a paper based medical record, an EHR leaves an electronic audit trail showing who entered the data and the time when a document was opened and modified, [as well as] who deleted or edited any of the information.

“More importantly,” continued the white paper, “the authors have found multiple reporting errors in EHR products in the final patient clinical note. For example, some audit trails only show the time stamp for the most recent change. If this information is used in a medical malpractice case, the data could force physicians to defend not just their final product, but the entire medical evaluation process.”

Anderson and Ozeran did not give the EHR industry a high score. They stated that “A review of 65 EHRs showed that more than 90% of them did not provide adequate medico-legal training and 95% of them had specific medico-legal issues. Either could increase the potential risk of a liability claim and would hamper its defense. The EHR vendor community should strongly consider external reviews of their software for potential medico-legal issues that may have been missed by internal reviews due to employee familiarity with the process and the product.”

Anderson and Ozeran also cite many liability risks that can be found in existing EHR products. For example, providers can turn off alerts in their EHR system because the need to respond to a large number of alerts causes “alert fatigue” or overload. Another risk is associated with the “cut and paste” method a provider uses to move clinical findings from one EHR section to another. This creates the opportunity for incorrect information to find its way into the patient’s record.

Meaningful Use Requirements Met with “Inaccuracies” to Be Resolved

As many pathologists and clinical laboratory managers know, the “Meaningful Use” criteria mandated by ARRA are being staged in three steps over the course of the next five years. Stage 1—the use of certified EHR in a meaningful manner—requires electronic health records to be functioning appropriately by the established deadline of 2012.

In a recent survey by KLAS, the market research group, 80% of 500 hospitals plan to use their emergency department information systems to meet Medicare’s Stage 1 Meaningful Use requirements. However, only about one-third of these 500 hospitals currently have a vendor and EHR system that supports MU criteria. The other EHR products lack compliance with MU requirements, as reported  by

It was in late October when Information Week published a story about how EHR vendor, GE Healthcare, announced what its Vice President and General Manager described as “inaccuracies” in its EMR’s software reporting functions It promised a “fix” by the end of November. The company’s Centricity Practice Solution and the Centricity EMR system were cited as possibly not being able to “successfully attest to Meaningful Use.” Those reporters and organizations who monitor Meaningful Use and EHR implementation suggest that healthcare will experience more reports of “inaccuracies” as EHR vendors take steps to repair functionality gaps in their products.

Transferring Patient Information from Paper to EHR Can Cause Errors

Simply transferring information from paper forms and files to a new EHR can create a potential liability risk for physicians and other healthcare providers. The paper health records for tens of millions of Americans must be transferred into an EHR via scanning methods or retyping the data. This alone poses a major challenge and begs the question of who will double-check for errors after the paper records of millions of patients are transferred into the EHR systems of hospitals and physicians.

One benefit from the widespread use of EHR systems may be better physician adherence to evidence-based medicine (EBM) care protocols that are built into many of these EHR systems. That could benefit clinical laboratories and pathology groups if such EBM protocols helped physicians utilize medical laboratory tests more appropriately.

It remains to be seen if the concerns of these health information technology experts prove true. Certainly some vendors may bring EHR systems to market that are not fully-debugged for every clinical function. However, as these bugs become known, physicians using these EHRs will certainly insist on timely fixes of these problems.

—Carren Bersch

Related Information:

Do EHRs Increase Liability?

CMS EHR Meaningful Use Overview and EHR Incentive Programs

GE Admits Inaccuracies with EHR Reporting: Centricity customers should hold off on Meaningful Use attestation until problem is fixed, the company says.

Most ED info system vendors can’t deliver Meaningful Use for providers

Meaningful Use: Phase 1 Lessons Learned and How to Prepare Your Lab for Phase 2 Requirements