Electronic Medical Records and the Question of Reliability

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Electronic Medical Records and the Question of Reliability The EHR debate is still on, with positive as well as adverse reports from various quarters, contributing to the general confusion regarding the efficacy of electronic medical records.

The systems available are being increasingly scrutinized by clinicians, many of whom feel that the technology is poorly regulated and often unreliable. Providers know that EHRs are promising in that they help to ensure improved patient health outcomes, reduced duplicate tests and considerable cost savings for the healthcare industry. However, serious design flaws and other concerns related to these digital systems cast a shadow on their optimism. Adding to their misgivings is the data on electronic health records malfunctions available at the U.S. Food and Drug Administration’s MAUDE (Manufacturer and User Facility Device Experience) website. Amidst their capabilities, EHRs also pose new risks for patients, and the full extent of the risk involved is not yet clearly known.

The rush to implement the new digital record system and cash in on the incentives has resulted in error-prone computer systems making their entry at breakneck pace into clinical settings. It is

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estimated that U.S doctors’ offices with EHRs showed a dramatic rise from 17% to 48%, and U/S hospitals showed an increase from 13% to 70% during the period 2008 – 2013.

Naturally, government regulators and medical institutions could not keep up with this pace. Very often, issues such as incorrect post-operative medical reconciliations are revealed only by a comprehensive review of relevant medical records.

The Dark Side of Electronic Medical Records Take this recent report for instance. In a study of relevant medical records, the investigators found that the postoperative medical reconciliation for ophthalmic medications after residentperformed cataract surgery was incorrect for a number of patients. More than half of the electronic medical records were incomplete and showed errors. The study team presented the results obtained from their retrospective review of electronic medical records during the poster session at the American Academy of Ophthalmology 2014 Annual Meeting. The study involved 258 patients who had undergone resident-performed cataract surgery in a single hospital over a one year period.

Even more distressing is the case of Theresa Robertson, the 46year-old visual artist from Weymouth who fell victim to a medication error – insulin overdose -- for which digitized records were partially responsible. The nurses in charge of her care were acting in response to multiple orders for insulin entered in two separate prescribing systems – paper and electronic. These were listed under the name of different doctors, which brought about the dangerous situation. The

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hybrid record systems failed to interact with each other and went on to create the human error.

Errors related to EHRs have caused many adverse and tragic incidents such as the above as revealed in various studies.

• Safety researchers for CRICO, a Harvard-affiliated malpractice insurance group found at least 147 instances where digital records contributed to adverse events that had a negative impact on patients.

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The cases studied were from a one-year period of fresh malpractice claims overlapping 2012 and 2013, comprising 5,700 cases. As reported by the Globe, 46 of those events resulted in patient death.

Pros and Cons It is vital to understand that electronic records are not perfect.

They have their plus and minus points, and after all, the entries are made by humans and errors may creep in. The most common concerns identified include: • Erratic use of hybrid records • Entry of incorrect data by medical staff • Wrong use of the cut and paste function. Here clinicians fail to update the daily notes of patients.

• Loss of data caused by computer glitches and crashes.

Medical staff would be left without access to important medical details of their patients.

• Poor systems design and slipshod implementation

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• Complex systems that frustrate providers who may ignore automatic warnings and develop workarounds in their effort to balance patient care and electronic documentation requirements.

Are EHRs Reliable As Legal Evidence?

Health information technology and compliance experts hold that electronic medical records must be verified for reliability before admitting them as evidence in legal proceedings. They point out that EHRs are designed to maximize payments to providers and do not necessarily reflect the care actually provided to patients.

The “litigious atmosphere in healthcare” offers incentives to implement and use electronic record systems that can “amend representations of events, according to considerations other than accuracy and reliability as legally sound records." The main problem with EHRs is that they are not subject to regulatory oversight unlike laboratory blood chemistry machines and Xrays, and this makes them unreliable. As the experts point out, unverified EHR documentation amounts to “hearsay” in court.

In a malpractice case, it is up to the provider to prove that their EHR is reliable. The IT manager in the healthcare organization would have to attest to the reliability and authenticity of the electronic health record. They will have to show that their audit functions cannot be turned off, corrupted or deleted. For electronic medical records to be really beneficial and present the actual patient care details during a comprehensive review, they have to be developed and maintained with thorough adherence to the best medical informatics and software engineering practices. Moreover, the various EHR systems must be able to share information with each other.