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.
Thanks for the wakeup call.
All we ever hear are success stories.
If we, as a healthcare informatics community are going to ever start doing better, we have to hear ALL the stories – the good, the bad, and the ugly. Who was it who said the definition of insanity was doing the same things over and over and expecting different results?
Add to your list microbiology result delays. Some studies show that 40% of hospitalized patients are on antibiotics. In the pre-eWorld as well as today, culture and sensitivity results are called to the accountable care provider. The same kinds of filing errors, delays, and just plain out-dated workflows delay getting patients on the right antibiotics. Over the previous decades, we’ve been seduced by “good enough.” The expectation of perfect care has new meaning for EHRs. It’s more than getting rid of paper and CPOE.
The other safety error that I’ve seen three times recently (all friends and family) — false positive results prematurely reaching the patient and their families. All of these examples involved imaging results: newly diagnosed lung cancer in one case, a deadly brain vascular anomaly in an asymptomatic child, and a near complete blockage of a carotid artery. In all cases, weeks later, more experienced radiologists and surgeons determined that the studies were over-read. In one case, the carotid ultrasound was exactly the wrong test for the patient (it was, of course, reimbursed; an MRA was what was needed and ultimately done.) A more methodical and timely workflow for such new and devastating findings is clearly needed. Aside from the emotional toll, these each delayed and complicated reaching the correct diagnosis.
AHRQ sees patient safety as a sub-class of quality problems. The above issues are process quality issues with existing systems. We need more than EHRs, as you clearly illustrated.
I am also a long-time warrior in the world of electronic medical records. There are several stragtegies that I have seen used that can help address the “what I don’t know” issues:
1. We run a “balance” routine for our results interfaces that compares the counts sent to the counts posted to the central results data base. That help us ensure that what was resulted was posted.
2. Before posting any result to a patient, we compare at least 3 demographic keys between systems (i.e. first 5 characters of last name, date of birth, MRN, Account number, etc.) IF there is no match, an exception report is immediately printed to a control point for resolution.
3. We have a process that all critical results are called to the physician in addition to posting in the record.
these steps help us ensure our electronics are in good shape.
Anthony Guerra says
Very interesting article just published in the Huffington Post: As Doctors Shift to Electronic Health Systems, Signs of Harm Emerge
I wonder if the bloom is finally coming off the CPOE rose. At the very least, I hope it comes to be generally realized that achieving the Meaningful Use objectives in the timelines laid out is a recipe for disaster.
Anthony Guerra says
Another article — less impactful — about problems in EMR implementation.
“An Unforeseen Complication of Electronic Medical Records“
Dale Sanders says
I particularly appreciate your check of inputs and outputs for results that are sent versus posted. I’d be interested to hear if you make that available to physicians in some sort of a data quality dashboard? In the rest of our lives, there are examples everywhere in which we display the status of the system to the operator. In healthcare we display the status of the patient via the EHR, but we don’t display the status of the EHR to the operator…that’s the system status that’s missing…the status of the data quality (completeness and validity) in the EHR is the unknown that leaves clinicians not knowing what they don’t know.
One saftey issue I struggle with on a daily basis is the integrety of my EMR medication list. Recenty one of my patients was treated in the ER and admitted. When the nurse contacted a covering physician, she read from an obsolete EMR list of meds from a previous admission. Of course they were wrong. The patient had an accurate list in his wallet but no one asked him. When he was discharged to rehab the facility changed his meds again for formulary reasons. Several weeks the patient was discharge with a new med list and a computerized list of medications. Unfortunately,he was overdosing on medication because the was taking both the generic and the brand version of the same drugs.
After much confusion, the med list was finally corrected in my office EMR. One month later I was asked to refill a presciption that was unknowingly change by his cardioloist. I unknowingly filled the wrong dose.
I still ask patients to bring in all their meds when they visit the office and I never trust the EMR med list.
Dale Sanders says
That’s a compelling story. There are those among us in Healthcare IT who argue that the EMR medication list is still better than nothing… still better than the “old way.” But I totally disagree.
Besides the challenges of multiple clinicians managing multiple lists and definitions of “active” and “inactive” medications, etc., the problem with the EMR is this false sense of validity, which by experience, you’ve naturally grown to distrust. We had a motto in the military (apologies for reliving war stories yet again): “The only thing worse than no intel [aka, data], is bad intel and we don’t know it.”
In the world of subjective intelligence gathering, the source of intel data is always listed alongside the information and the source of the information will also be graded according to its validity. Type 1 Intel: First hand observation by two or more credible sources; Type 2: Second hand knowledge passed from one credible source to another; etc. We give physicians very little if any framework with which to judge the validity of their intelligence data, never-mind the frequently incomplete data of which they are unaware.
You are doing the right thing by going directly to the patient’s medicine cabinet.