Risk Management



Documentation Issues in Paper & Electronic Records

OMIC Digest-No-2-FINAL-7-14-14 revAnne M. Menke, RN, PhD, OMIC Risk Manager

When lawsuits against policyholders are resolved and the claim is closed, OMIC asks insured ophthalmologists about 1) risk management issues that were brought to their attention by the claim and 2) the steps they have since taken to reduce exposure to this type of claim in the future. In our most recent surveys covering the latter half of 2013, fully half of the answers to the first question and a third of the responses to the second were about documentation problems that had impacted the claim. To better understand the precise type of documentation issues that influenced the outcome of recent cases, I reviewed OMIC lawsuits that closed in 2012 and 2013. This article will address the most common deficiencies, in decreasing order of frequency.

Operative report

Not surprising for a surgical specialty, operative reports are carefully scrutinized in ophthalmic surgery lawsuits. In many claims, the operative report failed to mention complications that led to poorer than anticipated outcomes and unhappy patients. The majority of OMIC claims relate to cataract surgery, and the main documentation deficiency in the cataract claims reviewed for this article was the absence of discussion of capsule rupture. This is a known complication and if it is documented, disclosed to the patient, and managed well, the defense attorney would argue that the outcome was a maloccurrence rather than malpractice.

In one such case, a patient alleged persistent glare, halos, corneal edema, and extreme light sensitivity caused by an irregular iris following cataract surgery. The defense expert reviewing the case explained that he could not determine if the standard of care was met or not based upon the operative report as it did not mention that the surgeon had performed an anterior vitrectomy, removed the entire capsular bag, and somehow injured the iris. The defense expert surmised that the ophthalmologist encountered floppy iris syndrome but noted that the only action documented in the medical record to address it was to administer Atropine. The insured ophthalmologist consented to settle and OMIC paid $200,000.

Other operative note deficiencies include failing to document an adverse event (see Closed Claim Study); operative notes that were pre-dictated but not amended to address complications; lack of any operative note at all (a LASIK surgeon explained that if the surgery had no complications, he did not dictate a report; see the discussion of this case under “Telephone care”); and two operative notes, dictated one day apart, offering different accounts of the surgery (the plaintiff dismissed the case before the reason for the two forms could be explored; defense counsel felt they would have posed problems for a successful defense).

Preoperative decision-making

Complications arising from surgical care would not have happened if the surgery had never taken place. Attorneys representing patients thus review the preoperative decision-making process carefully to determine if the surgery was indicated. In one case, a patient who experienced irregular astigmatism after implantation of a premium toric intraocular lens filed a claim. The defense expert felt that the surgery was indicated and had no concerns about the intra- or postoperative care, but questioned why the preoperative evaluation did not include keratometry, topography, or refractions from the patient’s recent preoperative visits, which would have helped assess the amount and type of astigmatism prior to surgery. The patient did not pursue the claim and it closed without payment.

In another case, a patient sued after developing diplopia and excessive scarring when a lid lesion was removed. One defense expert felt that the scarring could not have been anticipated and that the patient had experienced a rare, idiosyncratic immune response. Another defense expert, who sees many patients with the same type of benign lesion, questioned the need to remove it. He also criticized the lack of documentation about why the surgeon decided to excise it, as the record did not contain any patient complaints about problems the lesion was causing. With the consent of the insured ophthalmologist, the case settled for $95,000.

Informed consent

The adequacy of the informed consent discussion is often challenged in lawsuits. It is more difficult to obtain informed consent when the patient has limited English proficiency. In one of the cases reviewed, a Spanish-speaking patient had cataract surgery complicated by posterior capsule rupture and anterior vitrectomy. He sued after losing all vision following a postoperative retinal detachment. The only consent form found in his medical record was for a clinical trial in which he was not a subject, and there was no documentation about the use of a translator during the informed consent discussion with the non-Spanish-speaking surgeon. While there was support for the care, the poor outcome and lack of evidence of consent convinced the ophthalmologist to settle the case, for which OMIC paid $200,000. Documentation of consent for limited-English-proficiency patients should include the language in which the discussion took place and the name and relationship of any translators. OMIC has recommendations on the use of interpreters for both limited-English-speaking and deaf patients on our website.

Examinations and tests

A number of lawsuits would have been defensible if key exam elements had been documented. The most frequent problem stemmed from failure to document dilated retinal exams in patients who were later diagnosed with retinal detachments. In one such case, the ophthalmologist recalled dilating the eye but worried that the jury might not believe him, as he lived in an area where juries tended to side with the plaintiff. He decided to settle and OMIC paid $100,000.

Another surgeon also reported performing a dilated retinal exam. At his deposition, he was questioned because his documentation was in two different colors. He testified that the documentation about the dilated exam might have been added after he learned that another ophthalmologist had diagnosed a retinal detachment. His case settled for $320,000.

Another case involved a physician who was asked to quickly examine a patient for a colleague. She confirmed that the patient had a retinal detachment in the periphery and accordingly advised the patient to return to his retinal surgeon for the necessary operation. The physician considered this to be a “curbside consultation” and so did not document the encounter. The lack of documentation presented problems when she was later named as one of the defendants in a lawsuit. Regardless of her limited involvement with the patient, by examining him, she had established a physician-patient relationship for which a record was required. Fortunately for this physician, the plaintiff agreed to dismiss her from the lawsuit.

Telephone care

Ophthalmologists take after-hours calls from their own patients and those of their call partners as well as from emergency rooms when they are on-call. OMIC has regularly had to settle cases when the call has not been documented by the ophthalmologist, and his or her recall differs from the patient’s account or what the emergency room physician documented. In one case, a patient called her ophthalmologist after LASIK surgery to report red, irritated eyes and was told to continue to take the drops prescribed to alleviate dryness. She called again while out of town to report worsening vision. She testified that the only advice she was given was to continue taking her drops. The physician recalls urging her to go the local emergency room but did not document either call. The patient developed an infection and corneal ulcer that left her with halos and night driving problems. The defense was complicated by the absence of documentation of the two phone calls as well as the lack of an operative note. As mentioned under “Operative report,” this surgeon felt there was no need for an operative report for uncomplicated refractive surgery. The case settled for $50,000. Our website has contact forms for after-hours calls.

Contradictory records

Before the advent of electronic health records (EHRs), documentation deficiencies were predictable, stemming from illegible handwriting, missing pages, untimely entries, and questionable accuracy.1 Problems also routinely surfaced with pre-dictated operative reports that, as noted previously, were not amended to address intraoperative complications. EHRs have successfully addressed the handwriting issues and have been credited with preventing some types of harm, such as medication errors stemming from wrong doses, routes, allergies, or drug-drug interactions. Nonetheless, EHRs have also created unintended consequences, including new sources of error and harm, as two OMIC cases illustrate.

In one case, a child presented to the emergency room, where the ER physician noted a dilated, non-reactive pupil with a shallow laceration in the lower lid conjunctiva. He diagnosed traumatic hyphema and contacted the on-call ophthalmologist, who asked that the patient see him in his office the next day. The ophthalmologist’s EHR record from that outpatient visit indicated essentially normal findings of a round, reactive pupil without afferent pupillary defect (APD), and a white and quiet conjunctiva. The only abnormal finding was cell and flare in the anterior chamber, which led to a diagnosis of traumatic iritis. Before the recommended return visit, the patient lost vision and was seen by a physician covering for the ophthalmologist’s practice. After eliciting a history of sickle cell disease from the mother, the second ophthalmologist asked her to bring the child right in. The vision was NLP, the pupil was fixed and dilated, IOP was 46, and there was a 4+ APD. Despite treatment, the child ended up with HM vision and the parents sued. The ophthalmologist who initially saw the child reviewed his note and realized with dismay that the EHR had populated it with many normal findings. He fully intended to change the note later in the day but forgot to do so when his clinic got busy; indeed, it had never been signed as complete. There was no documented IOP, but the physician clearly remembered that he checked it himself when the staff member needed to leave the room to avoid becoming sick when the child vomited. The documentation problems, combined with criticism of his decision to treat the child over the phone instead of going to the ER, led OMIC to settle the case with his permission for $380,000.

Similar problems surfaced in another case with EHR in which the plaintiff alleged a delay in diagnosis of a retinal detachment. On several visits, the exam findings contradicted the physician’s assessment. Once, the findings showed cell and flare, yet the ophthalmologist discontinued the steroid drops and gave the patient a long follow-up period. The defendant physician explained he would never have stopped the steroids if the inflammation had continued and attributed the discrepancy in the records to use of the “carry forward” function, which automatically populated the record with the previous exam’s findings. On another key visit, the findings showed normal retina vessels and clear vitreous, yet the assessment was retinal vasculitis, which had prompted the ophthalmologist to refer the patient to a retina specialist. Plaintiff experts and the subsequent treating physician felt that the retinal detachment had been present for some time yet was not detected by the ophthalmologist. Problems with the records helped convince the ophthalmologist to settle for $290,000.

Risk management documentation strategies

In the event of a malpractice claim, the medical record often becomes the most important evidence used to determine whether or not the physician met the standard of care. While ophthalmologists have the opportunity to testify about documentation deficiencies, the plaintiff’s attorney will use the discrepancies to challenge the ophthalmologist’s credibility and diligence. This review of ophthalmic lawsuits shows that ophthalmologists need to pay particular attention to noting in the operative report any complications and how they were managed; the decision-making process when determining a diagnosis and course of treatment; informed consent discussions about risks, benefits, and alternatives of the proposed treatment; key pertinent positive and negative findings; and telephone conversations with the patient and other physicians.

Electronic health records introduce new sources of error and confusion. A growing body of literature warns of the risks that certain features of electronic health records pose to the integrity of the medical record. An Institute of Medicine (IOM) report addressed what it terms “e-Iatrogenesis,” defined as “patient harm caused at least in part by the application of health information technology (HIT).”2 The IOM report, which analyzed events in hospitals, found many problems associated with the implementation of HIT, including inaccurate and missing data, but a low level of harm caused by it. OMIC’s claims experience similarly shows that—so far—EHRs have mostly impacted the defensibility of the care. Please see the Hotline article for advice on how to ensure that EHRs produce accurate, reliable accounts of care.

1. Boyd D. “The Risks of Electronic Medical Records: Defending the Record.” ASHRM Forum. 2013;Q3:4-5.
2. IOM. “Roadmap for Provision of Safer Healthcare Information Systems: Preventing e-Iatrogenesis.”

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