The Doctor’s Advocate | First Quarter 2014
An EMR-Related Claim
On April 23, a 58-year-old female presented to the medical group’s Dr. A with symptoms of a urinary tract infection (UTI). In the electronic medical record (EMR)—an early EMR system considered dated by today’s standards—he documented the presence of a 2 cm left upper lobe thyroid mass and recommended a thyroid ultrasound (US).
On May 1, the patient’s US exam demonstrated a 2.3 cm mass in the left thyroid lobe. The differential diagnosis included a neoplasm, and a radioactive iodine uptake (RAIU) test was recommended. The US report was not available until May 10.
On May 5, the patient saw Dr. A for follow-up of her UTI. The US report was not yet available, so the EMR included no reference to the US study. His physical exam note stated, “The neck/thyroid is supple, without adenopathy or enlarged thyroid.” It was later assumed that this note was an EMR default setting for the history and physical (H&P) that Dr. A did not notice and then override to reflect the presence of the thyroid mass. On May 8, the patient called the group, requesting the results of the thyroid US. Staff advised that the US results were pending.
A note in the EMR dated May 10 stated, “Patient was seen by Dr. A, and an US on May 1 revealed a 2.3 cm left thyroid mass; a nuclear medicine scan to exclude neoplasm was recommended. EMR will have US report scanned.” The note also stated that Dr. B was the “rendering provider” (even though he was out-of-state on this date) and confirmed that someone in the group received the US report. Despite the instruction, the US report was not scanned into the EMR. In addition, there was no EMR documentation that the patient was advised to have a RAIU—and no indication of any attempt to schedule one.
On February 22 of the following year, the patient saw the group’s Dr. B for diarrhea and recent weight loss. On examination, he noted the solitary left thyroid nodule. He ordered a TSH and free T3/T4 and stated he would consider a thyroid US if these tests were normal. The patient didn’t mention that she’d had a thyroid US 10 months earlier. Dr. B subsequently stated that when the EMR was later printed, a section titled “Diagnostics History ” appeared and documented, “US exam of head and neck ordered April 23. ” He said that the patient’s diagnostics history did not appear on the computer screen when he made his note on this visit because “he did not know that he had to click on a drop-down menu to view it.” Therefore, during the patient’s February 22 visit, Dr. B was unaware of the patient’s US the previous year.
On March 16, the patient was seen by the group’s Dr. C to discuss her thyroid function test results (which were normal). The EMR entry noted “nontoxic uninodular goiter; etiology uncertain.” The patient mentioned the prior US study, but the May 1 US report was not in the EMR. Again, the Diagnostics History section did not appear on the screen, because Dr. C was also unaware that she had to click on a drop-down menu to see it. Dr. C ordered a thyroid US, which the patient had on March 24. The thyroid mass had increased in size from 2.3 to 4.1 cm, and the RAIU was ordered.
After numerous efforts to obtain authorization for the RAIU study, it was performed on June 30 (three months after being urgently requested) and showed a “photopenic mass in the left thyroid.” The possibility of malignancy was raised. An US-guided thyroid biopsy was performed on August 17. The group’s EMR did not contain the pathology report, but Dr. C noted that the biopsy showed medullary carcinoma of the thyroid. On October 4, the patient underwent a total thyroidectomy, left neck dissection, and tracheotomy. Left paratracheal nodes were positive, and tumor infiltrated the recurrent laryngeal nerve. The patient had not consented to a laryngectomy, so she returned to surgery three days later for a total laryngectomy.
Standard of Care Issues
The allegation was failure to take appropriate steps to timely diagnose thyroid cancer and refer for treatment. It is undisputed that the group received a copy of the US report on or about May 10. The patient denied being advised of the results of this US exam or of the need for the follow-up RAIU. When the patient returned on February 22 the following year, an evaluation of the thyroid mass finally began, and six months later the medullary carcinoma was diagnosed (16 months after her initial visit). It was alleged that this delay allowed the thyroid cancer to spread to the larynx and lymph nodes and shortened her life expectancy.
An internist and a family practice physician were not supportive of the patient’s care because no one followed up with the patient when the group received the US report on May 10, and, when the RAIU was recommended, there was no discussion with the patient about the importance of follow-up.
An otolaryngologist opined that a thyroidectomy would have been performed even without the delay in diagnosis, but he could not determine with certainty whether the delay caused the need for a laryngectomy. Absent a family history, it was probably a sporadic medullary carcinoma, and the prognosis was guarded due to a high tumor burden as evidenced by continued elevation of serum calcitonin levels. An oncologist opined the delay in diagnosis likely resulted in advancement from Stage II to Stage IV. He added that Stage III or IV medullary thyroid cancer has up to a seven-fold increased likelihood of death with disease-specific median survival of three to five years.
Multiple EMR-related problems contributed to this claim, which fundamentally resulted from poor physician(s)-patient communication. Issues in this case included the following:
- The autopopulation of data fields in the May 5 H&P, which stated, “The neck/thyroid is supple, without adenopathy or enlarged thyroid,” when the physician had documented the presence of a thyroid mass two weeks earlier. Some EMRs may autopopulate fields as a default in the H&P (with data derived from a prior H&P), in procedure notes (from personalized or packaged templates), and, apparently, in progress notes. Entering erroneous information into the EMR can create liability. For example, during deposition in a different case, some autopopulated fields in the physician’s EMR contained obviously incorrect information. The plaintiff’s attorney asked the physician these questions:
- “So is the information in this record accurate or not?”
- “Do you bother looking at your records?”
- “If these ‘autopopulated’ fields are incorrect, can we trust anything in this record?”
- “Do you deliver the same level of care as you do in record keeping?”
- Computer-assisted documentation uses drop-down menus, point-and-click lists, autofill, templates, and canned text to produce structured progress notes. These often contain redundant, formulaic information, making it easy to overlook significant clinical information. Communication with on-call and consulting physicians (and with patients) may be compromised. In this case, because Drs. B and C did not know how to view the Diagnostics History section, they were unaware of the prior US. Whether this situation resulted from insufficient user training or faulty software design is unknown. Be aware that vendor contracts may attempt to shift liability resulting from faulty software design onto the physician and that malpractice insurance policies may exclude coverage for product liability. Read all contracts carefully.
- It was later discovered that some of the group’s EMR problems involved difficulty accessing entry and progress notes from prior visits. The notes could be locked by the physician making the entry, rendering them inaccessible to subsequent physicians. However, if left unlocked, the name of the physician making the subsequent entry would be added to the unlocked prior note. This situation probably explains why the May 10 note stated that Dr. B was the rendering provider when he was out-of-state.
- The group’s IT personnel later established that the May 10 note was prepared on that date by Dr. C; for unknown reasons, the note did not become part of the patient’s EMR until two years later, on September 21—the same date the medical group received notice of a suit. They further discovered that sometime after September 21, someone unlocked the May 10 note, presumably modified it, and relocked it. Thus, there is no way to determine if the current version of the note is the same as the original note created on May 10.
Finally, the patient received a copy of the EMR before filing the complaint. Since the May 10 note was not yet in the EMR, the record she and her attorney originally received did not contain the note. Initially, these events resulted in suspicions of record alteration, but this allegation was not pursued when the problem of locking and unlocking EMR notes was discovered.
Be aware that during electronic discovery, lawyers may request copies of the EMR in native format, which shows how data was used. (Were alerts and prompts followed or overridden?) Attorneys will also request the metadata, which includes 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 EMR are time-tracked and discoverable.
- Doctors are responsible for information to which they have reasonable access—and there is increased access to e-health data from outside the practice from the practice EMR or website or through Health Information Exchanges, e.g., hospital charts, consultants’ reports, lab results, and radiology reports. In this case, the May 10 US report was posted on the radiology group’s website for downloading. Had the medical group accessed it, the delay in diagnosis that resulted in this claim might have been prevented.