Electronic Health Records

Like all technologies, some systems are better than others. The Centers for Medicare & Medicaid Services (CMS) has requirements for “meaningful use” that hopefully are correlated to “efficient and high-quality patient care.” Centers for Medicare & Medicaid Services. http://go.cms.gov/1hBL7Ox; Buntin MB, Jain SH et. al., Health Information Technology: Laying the Infrastructure for National Health Reform. Health Aff (Milwood) 29(6):1214-9. (2010). In a survey of EHR users, the Centers for Disease Control (CDC) found that 76% of adopters they surveyed were using systems that met the standards. Jamoon, E., Patel, V., et. al., Physician Experience with Electronic Health Record Systems That Meet Meaningful Use Criteria: NAMCS Physician Workflow Survey, 2011. NCHS data brief, no 129. Hywattsville, MD: National Center for Health Statistics. 2013.

Lawsuits

If providers have adopted EHR systems that don't meet the test, they surely would have something to complain about. Indeed there is a class action lawsuit pending in the Circuit Court of Miami-Dade County, FL, Pain Clinic of Northwest Florida Inc. v. Allscripts Health Care Solutions Inc., in which the plaintiffs complain that the product was defective and the company then discontinued it without addressing the defects. Another pending lawsuit in Montana, Mountainview v. Nextgen, (2013) (retrieved from http://bit.ly/1hBLtEM), claims that NextGen, the vendor, not only did not install the program properly, but did not meet the “meaningful use” standard. One of the practical things that providers can do is to refuse to sign contracts that immunize system developers. They can also invest time and effort before purchasing the product to ensure that the system meets the “meaningful use” standard and that it is customizable to the facility or practice where it is being installed. Mangalmurti, Sandeep, Murtagh, Lindsey et. al., Medical Malpractice Liability in the Age of Electronic Health Records, N Engl J Med, Vol. 363, Issue 21, p. 2060-2067, Nov. 18, 2010. It has yet to be tested whether third parties like IT companies could be held liable for errors if there is an adverse medical outcome.

What if the System Crashes?

Even when the EHR system is effective and providers are well trained, if a system crashes or malfunctions, the risk to patient safety is great. The U.S. Department of Veterans Affairs (VA) was an early and vigorous adopter of the EHR, with many documented benefits to patients. However, in 2008 a software problem that affected how EHRs were displayed resulted in patients in VA facilities throughout the country being given incorrect doses of drugs, facing delays in treatment, and experiencing medical errors. Wilson, JF, Making electronic health records meaningful. Ann Intern Med 2009 Aug 18; 151 (4):293-6.

The Learning Curve

When the EHR system has met the standard, the implementation period may still create risks. One federal court ruled that the failure to “implement a reasonable procedure during the transition period” ensuring that test results were timely delivered to physicians created liability for the providers. Smith v. United States, 119 F. Supp. 2d 562 (D.S.C. 2000). And there was a troubling study showing that mortality actually increased during the implementation stage of EHRs. Han YY, Cardillo JA et. al., Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, Pediatrics 2005; 116-1506-1512 (erratum); Pediatrics 2006; 117: 594. Similarly, the Pennsylvania Patient Safety Authority analyzed patient safety events related to EHRs, and identified hybrid workflow periods where both paper and electronic records were contributing factors in medical errors. The most common errors made during a hybrid workflow were omission and duplication of tasks, particularly with the delivery of medications. Sparnon, Erin, Pennsylvania Patient Safety Authority, Spotlight on Electronic Health Record Errors: Paper or Electronic Hybrid Workflows, Pennsylvania Safety Authority Reviews & Analyses, Vol 10 (no 2), June 2013.

There is a learning curve for any new technology. Training needs to consist of more than a short classroom orientation. Hands-on trainers who shadow providers while they learn speed up the process and reduce the mistakes that may happen otherwise. ECRI Institute, Healthcare Risk Control, Electronic Health Records, Vol. 2, Jan 2011, www.ecri.org.

Multiple Systems

Even if an EHR system is fully operational and staff are well trained to use it, problems may arise when it has to “talk” to other systems. If there is more than one system being used, medical tests may be duplicated ' or may not be done at all. Stewart, BA, Fernandex S, et al., A Preliminary Look at Duplicate Testing Associated with Lack of Electronic Health Record Interoperability for Transferred Patients, J Am Med Inform Assoc 2010 May 1; 17(3):341-4. EHR systems may not interface with each other, making it more confusing for providers, not less.

Next month, we will discuss other problems that have been observed in implementing EHRs, and at the potential effects of EHRs on medical malpractice claims.

Linda S. Crawford, a member of this newsletter's Board of Editors, teaches trial advocacy at Harvard Law School and consults with witnesses on research-based effectiveness at deposition and trial.

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Genesis Burkett was due to be home for Christmas. The premature infant in the neonatal intensive care unit (NICU) at Advocate Lutheran Hospital in Chicago was feeding and growing. Then a pharmacy technician typed in the wrong entry on an electronic health record (EHR) and the baby was given an overdose of sodium chloride ' 60 times the amount ordered by the physician. The baby died. Health Information Technology Raises Patient Safety Issues, Chicago Tribune, http://bit.ly/1kplIIa. Mistakes in computerized orders and other EHR errors have been implicated in deaths of other children. Walsh KE, Adams WG et. al., Medication Errors Related to Computerized Order Entry for Children. Pediatrics 2006; 118: 1872-1879; “Verdicts & Settlements Oct. 18, 2010: Failures in Care Alleged After Premature Birth.” Virginia Lawyers Weekly 18 Oct. 2010. Academic OneFile. Web. 14 Mar. 2014; Vitez, Michael, “When Medical Apologies Are Fodder for Suits,” The Philadelphia Inquirer, Nov. 6, 2011, http://bit.ly/1t0YDPZl. While EHRs are here to stay, what are the benefits and risks? Do they create more or less legal liability for medical providers?

'Meaingful Use'

There is a push to encourage health care providers to embrace EHRs. The HITECH Act of 2009 authorized grants and incentives to promote their “meaningful use.” Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), Pub. L. No. 111-5, Div. A, tit. XIII, Div. B, tit.IV Feb. 17 2009, 123 Stat. 226, 467 (codified in sections of 42 U.S.C.A.) There was a presumption that patients would be safer, but has that turned out to be true? Now that we are several years into this effort, the question becomes whether the hope of greater patient safety has proven to be true, and therefore translates to decreased liability for medical providers.

Like all technologies, some systems are better than others. The Centers for Medicare & Medicaid Services (CMS) has requirements for “meaningful use” that hopefully are correlated to “efficient and high-quality patient care.” Centers for Medicare & Medicaid Services. http://go.cms.gov/1hBL7Ox; Buntin MB, Jain SH et. al., Health Information Technology: Laying the Infrastructure for National Health Reform. Health Aff (Milwood) 29(6):1214-9. (2010). In a survey of EHR users, the Centers for Disease Control (CDC) found that 76% of adopters they surveyed were using systems that met the standards. Jamoon, E., Patel, V., et. al., Physician Experience with Electronic Health Record Systems That Meet Meaningful Use Criteria: NAMCS Physician Workflow Survey, 2011. NCHS data brief, no 129. Hywattsville, MD: National Center for Health Statistics. 2013.

Lawsuits

If providers have adopted EHR systems that don't meet the test, they surely would have something to complain about. Indeed there is a class action lawsuit pending in the Circuit Court of Miami-Dade County, FL, Pain Clinic of Northwest Florida Inc. v. Allscripts Health Care Solutions Inc., in which the plaintiffs complain that the product was defective and the company then discontinued it without addressing the defects. Another pending lawsuit in Montana, Mountainview v. Nextgen, (2013) (retrieved from http://bit.ly/1hBLtEM), claims that NextGen, the vendor, not only did not install the program properly, but did not meet the “meaningful use” standard. One of the practical things that providers can do is to refuse to sign contracts that immunize system developers. They can also invest time and effort before purchasing the product to ensure that the system meets the “meaningful use” standard and that it is customizable to the facility or practice where it is being installed. Mangalmurti, Sandeep, Murtagh, Lindsey et. al., Medical Malpractice Liability in the Age of Electronic Health Records, N Engl J Med, Vol. 363, Issue 21, p. 2060-2067, Nov. 18, 2010. It has yet to be tested whether third parties like IT companies could be held liable for errors if there is an adverse medical outcome.

What if the System Crashes?

Even when the EHR system is effective and providers are well trained, if a system crashes or malfunctions, the risk to patient safety is great. The U.S. Department of Veterans Affairs (VA) was an early and vigorous adopter of the EHR, with many documented benefits to patients. However, in 2008 a software problem that affected how EHRs were displayed resulted in patients in VA facilities throughout the country being given incorrect doses of drugs, facing delays in treatment, and experiencing medical errors. Wilson, JF, Making electronic health records meaningful. Ann Intern Med 2009 Aug 18; 151 (4):293-6.

The Learning Curve

When the EHR system has met the standard, the implementation period may still create risks. One federal court ruled that the failure to “implement a reasonable procedure during the transition period” ensuring that test results were timely delivered to physicians created liability for the providers. Smith v. United States , 119 F. Supp. 2d 562 (D.S.C. 2000). And there was a troubling study showing that mortality actually increased during the implementation stage of EHRs. Han YY, Cardillo JA et. al., Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, Pediatrics 2005; 116-1506-1512 (erratum); Pediatrics 2006; 117: 594. Similarly, the Pennsylvania Patient Safety Authority analyzed patient safety events related to EHRs, and identified hybrid workflow periods where both paper and electronic records were contributing factors in medical errors. The most common errors made during a hybrid workflow were omission and duplication of tasks, particularly with the delivery of medications. Sparnon, Erin, Pennsylvania Patient Safety Authority, Spotlight on Electronic Health Record Errors: Paper or Electronic Hybrid Workflows, Pennsylvania Safety Authority Reviews & Analyses, Vol 10 (no 2), June 2013.

There is a learning curve for any new technology. Training needs to consist of more than a short classroom orientation. Hands-on trainers who shadow providers while they learn speed up the process and reduce the mistakes that may happen otherwise. ECRI Institute, Healthcare Risk Control, Electronic Health Records, Vol. 2, Jan 2011, www.ecri.org.

Multiple Systems

Even if an EHR system is fully operational and staff are well trained to use it, problems may arise when it has to “talk” to other systems. If there is more than one system being used, medical tests may be duplicated ' or may not be done at all. Stewart, BA, Fernandex S, et al., A Preliminary Look at Duplicate Testing Associated with Lack of Electronic Health Record Interoperability for Transferred Patients, J Am Med Inform Assoc 2010 May 1; 17(3):341-4. EHR systems may not interface with each other, making it more confusing for providers, not less.

Next month, we will discuss other problems that have been observed in implementing EHRs, and at the potential effects of EHRs on medical malpractice claims.

Linda S. Crawford, a member of this newsletter's Board of Editors, teaches trial advocacy at Harvard Law School and consults with witnesses on research-based effectiveness at deposition and trial.

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