Patient Safety and Electronic Health Records

Below is a discussion motivated by four sentinel events which were root-cause attributable to electronic health records (EHRs) for which my teams and I were personally responsible.

Remember when safety belts in automobiles first became popular? They were simple lap belts, no shoulder strap. Did they aid passenger safety? Yes, in some ways… but they also introduced the danger of a whole new range of injuries, such as lumbar separation and paralysis, which hadn’t previously existed. It wasn’t until we added shoulder straps and the three point anchor to seat belts in cars that the evidence of benefit to passenger safety became clear and without question. We need pause now and add shoulder straps to EHRs.

Recent discussions at the national level about the patient safety effects of electronic health records are encouraging. The Wall Street Journal, Huffington Post, ONCHIT, Congress, and the FDA are starting to pay attention. But I laughed sadly and out loud when I read that the FDA estimated 44 patient deaths in the last two years “might be” attributable to the use of EHRs. That number is lowly inaccurate and also ignores all the other undesirable patient safety risk scenarios, besides death, that deserve attention.

Speaking from 13 years in the trenches of EHR-use at a variety of healthcare organizations, and applying a dash of country-boy common sense, I don’t need a fancy and sophisticated, multi-year analysis to tell me that the impact is orders of magnitude higher—it’s 100 times higher, at least. There are unintended consequences of EHRs upon patient safety every day in every hospital that uses an EHR.

Here’s a brief discussion of only four of the many patient safety events that happened under my watch, that were directly attributable to an EHR.

Missed diagnosis for soft tissue sarcoma: In this accident, a soft tissue sarcoma went undiagnosed for at least 3 months, possibly as long as 6 months, because the radiologist’s report from the Radiology Information System failed to file properly in the EHR and the referring physician didn’t know what they didn’t know and failed to follow-up on the results of the scan. The young mother of three went untreated, the cancer spread to the point that it was untreatable, and she died. The case was settled out of court for several hundred thousand dollars.

Acute Renal Failure from lack of lab results: The patient was administered a contrast dye in preparation for an imaging procedure, even though a recent lab test revealed compromised kidney function. The lab result failed to file properly in the EHR and the ordering physician didn’t know what they didn’t know. The patient suffered Acute Renal Failure and the case was quietly settled out of court for several hundred thousand dollars.

Missed and inappropriate diagnosis for Congestive Heart Failure: The echo report from the cardiologist clearly indicated that the patient was suffering from a very low LVEF, but the report did not file to the correct patient record—it filed to the wrong patient record. The correct patient went untreated and eventually died. The incorrect patient received aggressive medication treatment for CHF when that treatment was unnecessary. The case was quietly settled out of court. The CHF patient’s family was given a seven figure settlement, with a requirement to keep the incident quiet. The other patient’s family was given an apology.

Infant death: A young, single and non-English speaking mother was in hard labor and her baby under duress, but the Application Programming Interface (API) failed which had been developed to capture contraction waveforms and fetal heart data and then display those for remote viewing in the EHR. This software error also caused the fetal monitor to stop generating local audible alarms. The nurses were left unaware of the patients’ condition and the treating OB/GYN, who was monitoring the patient from his home via the patient’s EHR, was left unaware. The young and frightened mother continued quietly through her labor, giving birth in the hospital bed, unattended. Her baby was born brain-dead and later died due to umbilical strangulation.

There is reasonable but not widespread or entirely tangible evidence that EHRs can reduce patient safety events — drug-drug interactions being the most obvious — though if you’ve seen the way the vast majority of drug-drug interaction alerts function in EHRs, those alerts are of little value to physicians the vast majority of the time and are generally ignored.

Though EHRs might reduce some patient safety events, I’ve seen first-hand that the use of EHRs can also introduce new categories and types of events that we cannot ignore in the rush to deploy them across the United States. We have enough experience and evidence with EHRs to pause and do better with their impact on patient safety going forward. It doesn’t take a rocket scientist’s analysis to make immediate and major improvements to this environment, and we don’t need to wait until 2013 to develop a national database to simply begin ‘measuring’ the problem.

We need to implement mandatory reporting of safety-related EHR events — no more back-room, secret meetings and out-of-court settlements — what if we allowed the FAA to function in safety secrecy like that after a plane wreck? And we need to implement immediate requirements for auditable best practices in the development and deployment of EHRs, especially in the form of rigorous testing (for example, inverse requirement testing, as is common in military and nuclear power systems) and independent verification and validation of software code, including that associated with HL7 interfaces.

And we need to do it today so an electronic system is never responsible for doctors not knowing what they don’t know.