The Doctor’s Advocate | Fourth Quarter 2017
We rigorously analyze the claims experience of our 80,000 members and translate the findings into patient safety initiatives that protect our members and their patients. Analyzing the collective experience of so many physicians provides broader, more reliable information.
We hope that the information presented here will prompt physicians to collaborate with colleagues and hospital leaders to identify system weaknesses, thereby reducing the risk of harm to patients.
Read the full study at thedoctors.com/ehrstudy.
We became aware of potential liability risks related to the use of EHRs shortly after their introduction, and we anticipated that EHRs would become a contributing factor to medical professional liability claims. A search of The Doctors Company’s closed claims database from 2007 to 2010 revealed only two EHR-related claims. As shown in FIGURE 1, the number of claims has increased continuously over the past 10 years.
The 97 EHR-related claims that closed from January 2007 through June 2014 were previously reported in “Analysis of EHR Contributing Factors in Medical Professional Liability Claims” (Study 1). An additional 66 EHR-related claims from July 2014 through December 2016 are now closed and are the subject of this report (Study 2).
In Study 1, EHR-related factors contributed to 0.9 percent of all claims that The Doctors Company closed from January 2007 through June 2014. System factors contributed to 42 percent of these EHR-related claims, and user factors contributed to 64 percent.
In Study 2, EHR-related factors contributed to 1.6 percent of all claims that The Doctors Company closed from July 2014 through December 2016. System factors were present in 33 of the 66 claims (50 percent), and user factors were present in 38 of the claims (58 percent). Eight claims contained either more than one user or system factor or both.
FIGURE 2 compares how system factors involving technology, design, and security issues contributed to the EHR-related claims in Studies 1 and 2. Note that because a claim may contain more than one system or user factor—or both—the percentages may not add up to 100 percent.
The following cases illustrate system and user factors that contribute to EHR-related claims.
An elderly female saw an otolaryngologist for ear/nose complaints. The physician intended to order Flonase nasal spray. The patient filled the prescription and took it as directed. Ten days later, she went to the emergency room (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 approved by the U.S. Food and Drug Administration (FDA) for females. There was no EHR Drug Alert available for gender.
A physical medicine physician (PMP) followed a patient with extremity weakness due to a cervical vascular malformation. For four consecutive days, he entered identical progress notes into the hospital EHR, noting no change in symptoms, while nurses and physical therapy (PT) documented progressive neurologic changes. On the fifth day, PT spoke to the PMP regarding the patient’s deteriorating motor strength. The PMP ordered a neurosurgical consult but again entered the identical progress note into the EHR. The patient underwent decompressive surgery but now has incomplete quadriplegia. Defense experts concluded the identical progress notes resulted from copying and pasting.
A 35-year-old obese male presented to the insured for medical clearance. An ECG showed normal sinus rhythm, normal chest x-ray, heart rate 78, and BP 124/78. Three months later, he returned to the office complaining of chest pain, shortness of breath, and dizziness. His BP was 112/90 and pulse 106. Five days later, he died from pulmonary embolism due to deep venous thrombosis. Defense experts questioned whether the physician had done a complete assessment, because the progress note from the most recent visit appeared identical to the prior visit’s progress note—including the same spelling errors—suggesting that the note had been copied and pasted.
A female had a bladder sling inserted for urinary incontinence. Her surgeon was assisted by a proctor surgeon 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.
FIGURE 3 compares how user factors contributed to the EHR-related claims in Studies 1 and 2. Some claims contained more than one contributing user factor.
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.
A patient saw a hand surgeon due to pain in his left ring finger since a laceration two weeks prior. An x-ray showed no fracture. An MRI was not performed. The surgeon mistakenly documented the right ring finger throughout his EHR note, using an improper template for the patient’s injury. It contained extraneous pieces of inaccurate default information (including mentioning a fracture and a medication the patient did not receive). It did not contain follow-up instructions, and the surgeon never finalized or signed the note electronically.
Six months later, the patient saw a different surgeon, who noted the left ring finger had no flexor tendon function. An MRI showed a complete tear. Subsequently, the first surgeon reviewed his EHR note from the initial visit and “corrected” the inaccuracies. He removed mention of a fracture, corrected the medication entry, and stated the patient had been told to follow up in 10 days. He then electronically signed and finalized the note. Defense experts were not supportive of the standard of care.
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.
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 methicillin-resistant Staphylococcus aureus infection. The gynecologist had not been trained on the new system so did not find the new CT scan that was available.
In Study 2, we analyzed the 66 EHR-related claims to determine where the EHR claim events occurred, which specialties were involved, and the most common allegations. FIGURES 4, 5, and 6 compare the findings in Studies 1 and 2.
The Doctors Company supports the integration of the EHR into physician office practices (currently at 80 percent) and hospitals (currently at 90 percent) and believes this has great potential to advance both the practice of good medicine and patient safety. However, there are always unanticipated consequences when new technologies are rapidly adopted—and the EHR is no exception.
Many EHR-related problems could have been avoided if the federal government had developed vendor standards for EHR use and interoperability and required beta testing in the healthcare environment to ensure usability and safety before the HITECH Act mandated its widespread adoption in 2009. However, the impetus for the rapid implementation of EHR use was to enable the transition from a volume-based (fee-for-service) payment system to an outcome-based (pay-for-performance) payment system—not to optimize productivity, workflow, and communication. Physicians and other healthcare workers played a minimal role in the initial design of the EHR, and their subsequent workplace experience and concerns have been largely ignored. Optimization of the EHR beyond the current model (digitization of the written medical record) will likely take many years and involve redesigning workflow, creating standardized protocols, using artificial intelligence, and applying big data techniques to healthcare, etc.1
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. In 2015, the Office of the National Coordinator for Health Information Technology (ONC) developed a plan to create a Health IT Safety Center to minimize EHR-related patient safety risks through the collection and analysis of event data reported by users. However, if implemented, the Health IT Safety Center is unlikely to include an online mechanism for users to report EHR-related adverse events in “real time” when they occur.
Typically, the EHR is a contributing factor in a medical malpractice claim rather than its primary cause. In Study 2, user factors (conversion issues, discrepancy between free text and templates, copy-and-paste issues, data entry errors, alert issues, user fatigue, workarounds, etc.) contributed to 58 percent of EHR-related claims, and system factors (systems technology and design issues, data routing problems, inappropriate drop-down menu responses, failure of alerts, alarms, and clinical decision support [CDS], etc.) contributed to 50 percent. Some claims contain both system and user factors.
Of all claims closed by The Doctors Company from January 2007 through June 2014 (7.5 years), 0.9 percent (97 claims) had EHR-related contributing factors. In this follow-up study of all claims closed from July 2014 through December 2016 (2.5 years), 1.6 percent (66 claims) had EHR-related contributing factors. This is a relatively small increase over Study 1 and may not be statistically significant, considering that the data have not been adjusted for the increased utilization of EHRs during the time frame covered in Study 2. It is reassuring that the incidence of EHR-related claims has remained low over a 10-year time frame (2007 through 2016). It suggests that EHR-related risks, while real, are relatively uncommon and infrequently result in adverse patient events of sufficient severity to develop into malpractice claims. While we have not analyzed our written health record (WHR)–related claims, it is likely that the WHR and EHR risk magnitudes are similar—and considering that WHR documentation issues are quite frequently a contributing factor to claims, the WHR risk may well be higher.
User factors accounted for 64 percent and system factors accounted for 42 percent of the 97 EHR-related claims that closed from January 2007 through June 2014. In contrast, in the 66 EHR-related claims that closed from July 2014 through December 2016, user factors accounted for 58 percent (a decrease of 6 percent) and system factors for 50 percent (an increase of 8 percent).
The 6 percent decrease in user factors may reflect greater user familiarity with the EHR, resulting from experience as well as greater awareness of the risks. However, it is difficult to explain the 8 percent increase in system factors; perhaps this increase reflects a growing sophistication in the analysis of the causes of EHR-related adverse events.
When compared with the findings of Study 1, more EHR-related claim events occurred in patient rooms, and fewer occurred in hospital clinics/doctors’ offices, ambulatory/day surgery centers, labor and delivery, and ERs. Overall, with regard to the medical specialties involved in these events, internal medicine, hospital medicine, and cardiology showed marked decreases. Family medicine and nursing also showed decreases, while orthopedics, emergency medicine, and obstetrics/gynecology showed increases.
The top four factors responsible for over half of EHR-related claims are issues related to hybrid records/conversion from paper records, prepopulating and copying and pasting, EHR fragmentation (components of a patient encounter not located together), and EHR technology/design (formulary/templates out of date, etc.).
Diagnosis-related allegations were the most common allegation, and this was true whether the EHR-related issue involved user or system factors. Diagnosis-related allegations increased to 32 percent of all allegations in this study from 27 percent in the earlier study. User factors were involved in 21 percent of these diagnosis-related allegations, and system factors were involved in 15 percent.
Medication-related allegations were the second most common allegation, increasing to 23 percent of all allegations in this study from 19 percent in the earlier study.
Special thanks to Lisa McCorkle, MSN, CPHRM, Patient Safety Risk Manager II, The Doctors Company, and Darrell Ranum, JD, CPHRM, Vice President, Patient Safety and Risk Management, The Doctors Company.
The Doctor’s Advocate CME activity for this quarter includes reading the Electronic Health Record Closed Claims Study. After reading the study, you will be asked a series of questions. The activity is approved for CME credit and is available at thedoctors.com/ehrCME.
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 considering the circumstances of 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.
Fourth Quarter 2017
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