Analysis of EHR Contributing Factors in Medical Professional Liability Claims
Shortly after electronic health records (EHRs) began to be widely adopted, The Doctors Company and other medical professional liability insurers became aware of their potential liability risks. We anticipated that EHRs would become a contributing factor in medical liability claims.
Due to the three- to four-year lag time between an adverse event and a claim being filed, however, EHR-related claims have only recently begun to appear. In 2013, we began coding closed claims using 15 EHR contributing factor codes (eight for system factors and seven for user factors) developed by CRICO Strategies for its Comprehensive Risk Intelligence Tool (CRIT).
In 2013, The Doctors Company closed 28 claims in which the EHR was a contributing factor, and we closed another 26 claims in the first two quarters of 2014. During a pilot study to evaluate CRICO’s EHR codes, 43 additional claims closed by The Doctors Company were identified (22 from 2012, 19 from 2011, and 2 from 2007–2010). These 97 EHR-related claims closed from January 2007 through June 2014 are the subject of this analysis.
EHR-related factors contributed to 0.9 percent of all claims closed by The Doctors Company from January 2007 through June 2014. User factors contributed to 64 percent of these EHR-related claims, and system factors contributed to 42 percent.
The following tables and representative claims illustrate how the eight EHR system factors and seven EHR user factors contributed to the 97 closed claims. Some claims contained more than one contributing factor.
|EHR System Factors: Technology, Design, and Security Issues|
|10%||Failure of system design.|
|9%||Electronic systems/technology failure.|
|7%||Lack of EHR alert/alarm/decision support.|
|6%||System failure—electronic data routing.|
|4%||Insufficient scope/area for documentation.|
|0%||Lack of integration/incompatible systems.|
|0%||Failure to ensure EHR security.|
Claim: Lack of EHR Drug Alert
An elderly female saw an otolaryngologist for ear/nose complaints. The physician intended to order Flonase nasal spray. Patient filled the prescription and took it as directed. Ten days later, she went to the ER for dizziness. Two weeks later, the pharmacy sent a refill to the physician at his request. It was for Flomax (for enlarged prostate)—which has a side effect of hypotension. When ordering, the physician typed “FLO” in the medication order screen. The EHR automatched Flomax, and the physician selected it. Flomax is not FDA-approved for females. There was no EHR Drug Alert available for gender.
Claim: Lack of EHR Drug Alert
A dialysis patient transferred to a skilled nursing facility. There was an active hospital transfer order for Lovenox. A physician evaluated the patient on admission but made no comment about the Lovenox order. During the first dialysis treatment, there was active bleeding at the fistula site. Heparin (anticoagulant) had not been given. Nursing did not inform the physician of the bleeding. During the second dialysis treatment, there was uncontrolled bleeding from the fistula. The patient exsanguinated and expired. Experts were critical that there was no EHR High-Risk Medication Alert.
Claim: Insufficient Area for Documentation; Drop-Down Menu
A female had a bladder sling inserted for urinary incontinence. Her surgeon was assisted by a proctor surgeon who was representing the product manufacturer and training the patient’s surgeon on the procedure. The patient was informed that another physician would be assisting. In the recovery room, there was blood in the Foley catheter, so the patient was returned to surgery. The bladder had been punctured by the sling. The proctor had approved the sling’s placement. The circulating nurse did not document the proctor’s presence in the OR due to lack of an option in the EHR drop-down menu. There was no space for a free-text narrative to document that the patient was informed of the proctor’s presence.
Claim: Incorrect Information in EHR
A patient was seen by her cardiologist for hypertension. In the written medical record, her blood pressure medication had been increased to 25 mg once a day. Office staff entered the order into the EHR as twice a day. The prescription was filled. The patient missed her follow-up appointment. Seven months later, she went to the ER with numbness and weakness. Her potassium level was low. The cardiologist corrected the prescription error and gave her potassium.
Claim: Copy and Paste
A toddler was taken to a country where tuberculosis was prevalent. After the trip, he presented with fever, rash, and fussiness. The physician considered bug bite or flu and treated the child with fluids, antibiotics, and flu meds. His office EHR progress note indicated there was no tuberculosis exposure. The physician copied and pasted this information during subsequent office visits with no revision to note travel to a country with tuberculosis. Two weeks later, the child was diagnosed in the ER with tuberculous meningitis. He had permanent and severe cognitive defects.
|EHR User Factors: EHR-Related Issues Attributable to Users|
|16%||Incorrect information in the EHR.|
|15%||Hybrid health records/EHR conversion.|
|13%||Prepopulating/copy and paste.|
|7%||EHR user error (other than data entry).|
|3%||EHR alert issues/fatigue.|
Claim: Drop-Down Menu
A patient was seen by her physician for pain management with trigger point injections of opioids. The physician ordered morphine sulfate (MS) 15 mg every eight hours. In the EHR, the drop-down menu offered MS 15 mg followed by MS 200 mg. The physician inadvertently selected MS 200 mg and did not recheck before completing the order. The patient filled the prescription, took one MS along with Xanax, and developed slurred speech—resulting in an ER visit with overnight observation.
Claim: EHR Conversion; Incorrect Information in EHR
A patient with Tourette’s syndrome was treated with Haldol 0.5 mg documented in the written record. The patient called the office requesting a refill. The nurse entered “Haldol 5.0 mg” in the new EHR for an electronic script. This refill request showed up as a task for the physician to complete. The EHR was new, and it was the first script for this patient. The intended dose (0.5 mg) was therapeutic. The patient took the new dose (5.0 mg) for six months before the office staff discovered the error. The patient had side effects: cough, weight loss, and not feeling well.
Claim: EHR Training
A pregnant non-English-speaking female with gestational diabetes was referred for an ultrasound (US) to estimate fetal weight. Her physician had planned a C-section if the baby was >4500 grams. The US report was sent by the laboratory to the hospital’s EHR. The next day, the patient went to the hospital in labor. Her physician reviewed his six-week-prior prenatal written record but was not trained on the hospital’s EHR and had no password—so he did not see the US report. He performed a vaginal delivery, complicated by shoulder dystocia that resulted in brachial plexus injury. The baby’s weight was 4640 grams.
Claim: EHR Training
A female presented to the ER with complaints of abdominal pain, nausea, and vomiting. An ovarian cyst had been removed two years prior. The emergency physician ordered an abdominal CT scan and called a gynecologist to evaluate the patient. The gynecologist reviewed a CT scan in the EHR that was later found to be the old scan showing the ovarian cyst. The patient was taken to surgery. No cyst was found, and the patient developed a MRSA infection. The gynecologist had not been trained on the new system so did not find the new CT scan that was available.
Analysis of Location, Specialty, and Top Allegations
We also analyzed the 97 EHR claims to determine where the claim events occurred, which specialties were involved, and the most common allegations. The tables that follow outline our findings.
|Locations Where EHR Claim Events Occurred|
|43%||Hospital Clinic/Doctor’s Office|
|5%||Labor and Delivery|
|1% each||Pathology, ICU, Neonatal ICU, Radiation Therapy, and Special Procedures|
|EHR Claim Events by Specialty|
|20%||Internal Medicine Specialties— Cardiology/Hospitalist/Oncology/GI|
|16%||Primary Care—Family/ Internal Medicine|
|14%||Surgical Specialties (other than cardiac surgery)|
|4% each||Anesthesiology and General Surgery|
|2% each||Pediatrics, Emergency Medicine, Psychiatry, and Orthopedics|
|Top Allegations in EHR Claims|
|27%||Diagnosis-Related (Failure, Delay, Wrong)|
|7% Ordering wrong medication|
|5% Ordering wrong dose|
|7% Improper medication management|
Analysis of EHR-Related Claims
The Doctors Company studied 97 closed medical malpractice claims in which electronic health records (EHRs) were a contributing factor, revealing the top patient allegations and the most common factors that lead to patient injury. This two-part video series analyzes the growing risk of EHRs in malpractice claims and features several examples of EHR-related claims.
Recap of the Reported Risks of EHRs
The 2011 Institute of Medicine report, Health IT and Patient Safety: Building Safer Systems for Better Care, concluded that the information needed to analyze and assess health IT (HIT) safety and use was not available and that our understanding of the benefits and risks of EHRs was anecdotal. The report recommended creating a government agency that would systematically and uniformly collect data to investigate harm and safety events related to HIT. The Office of the National Coordinator for Health Information Technology is now developing a plan to create a Health IT Safety Center.
In the second quarter 2012 issue of The Doctor’s Advocate, I outlined the EHR benefits and corresponding risks reported in the medical literature. Here is a recap:
- EHRs improve medical record documentation and legibility. However, point-and-click lists, drop-down menus, templates, canned text, and autopopulation of data fields from personalized or packaged templates (for both procedure notes and the history and physical [H&P]) produce redundant, formulaic information that makes it easy to overlook significant clinical information.
- EHRs facilitate medication reconciliation and management and include alerts for improper drug dosages and drug allergies. However, frequent drug-drug interaction alerts lead to “alert fatigue,” sometimes causing physicians to override or disable them.
- EHRs facilitate e-prescribing—which also creates exposure to community medication histories where drug-drug interactions are time-consuming to trace.
- EHRs improve presentation of data for clinical decision making. However, providers often copy and paste information from prior notes into new notes (and, hopefully, edit as appropriate). This contributes to irrelevant, sometimes erroneous, over-documentation.
- Templates with drop-down menus facilitate data entry but are often integrated with automated features elsewhere in the EHR, where errors can be easily overlooked and disseminated. If an item is selected above or below the one desired, for example, “qd” can become “qid.”
- Clinical Decision Support (CDS) systems provide alerts, warnings, and reminders for medication and chronic disease management. This information may conflict with a medical specialty’s clinical standards of care or practice guidelines— and with the information in FDA-approved drug labels. EHRs document clinical decision making, including all departures from CDS guidelines. A physician should always document why a CDS prompt was overridden.
- Meaningful Use 2 (MU2) requires delivery of clinically relevant, disease-specific educational and drug safety materials to patients. Providers are responsible for the content of these materials.
- Vendor contracts may shift liability resulting from faulty software design or CDS from the vendor onto the user. Read all contracts carefully.
- During discovery, lawyers will request EHR metadata that documents logon and logoff times, what was reviewed and for how long, what changes or additions were made, and when the changes were made. All physician interactions with the EHR are time-tracked and discoverable.
- Transitioning from paper to EHRs can be risky. You must comply with federal and state record retention laws before destroying any written records.
To see the complete article that appeared in The Doctor’s Advocate, go to www.thedoctors.com/advocate and select the second quarter 2012 issue from the drop-down menu.
Special thanks to Lisa McCorkle, MSN, CPHRM, Patient Safety Risk Manager, The Doctors Company; and Darrell Ranum, JD, CPHRM, Vice President, Patient Safety and Risk Management, The Doctors Company.
The Doctor’s Advocate is published by The Doctors Company to advise and inform its members about loss prevention and insurance issues.
The guidelines suggested in this newsletter are not rules, do not constitute legal advice, and do not ensure a successful outcome. They attempt to define principles of practice for providing appropriate care. The principles are not inclusive of all proper methods of care nor exclusive of other methods reasonably directed at obtaining the same results.
The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.
The Doctor’s Advocate is published quarterly by Corporate Communications, The Doctors Company. Letters and articles, to be edited and published at the editor’s discretion, are welcome. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of The Doctors Company. Please sign your letters, and address them to the editor.