James Shwayder, MD, JD

A 57-year-old G5P5005 was seen by gynecology at a teaching hospital outpatient facility for chronic pelvic pain. A review of the patient’s history revealed that 6 months earlier she had been admitted to the hospital for severe bilateral lower quadrant abdominal pain, crampy in nature with significant bloating. The patient had a history of an appendectomy and 5 prior cesarean deliveries. 

She  had an ultrasound in the emergency department revealing a 5.0 x 4.7 x 3.8 cm complex right adnexal mass consistent with a probable dermoid with no definite evidence of torsion. A CT scan showed a right pelvic mass, probably a dermoid, with probable diverticulosis without abscess. Comment was made that there was inflammatory fat stranding that was probably related to diverticula through the sigmoid suggestive of diverticulitis. Gynecology and surgery were consulted during the hospitalization. Gynecology opined that although the patient had a pelvic mass, the stronger suspicion was that of diverticulitis. General surgery treated the patient with intravenous hydration and antibiotics, with improvement, and the patient was subsequently discharged home without the need for surgery. 

The patient was treated in the following 6 months by her primary care physician for continued pelvic pain. This included nonsteroidal anti-inflammatory drugs (NSAIDs) and occasional narcotics over 4 months, without significant relief. Thus, she was referred for further gynecologic evaluation. 

On a gynecology visit 6 months after the above evaluation the patient’s exam revealed moderate bilateral adnexal tenderness. Her BMI of 39 kg/m

 prevented palpation of any adnexal masses. She was referred for a pelvic ultrasound, which  revealed a unilocular, heterogeneous, solid cyst, involving the entire right ovary consistent with a dermoid. The ovary itself measured 5.74 x 5.28 x 3.36 cm. Doppler studies were performed which were normal (benign). The patient’s prior records were requested but were unavailable as her appendectomy and cesarean deliveries had been performed in another country. In addition, the patient was referred to her primary care physician for preoperative treatment of diabetes. She was seen 6 days after the initial gynecology outpatient appointment. It was noted that her diverticulosis was stable. However, the patient required further insulin adjustments to bring her diabetes under good control. 

The patient was seen again by her gynecologist 1 week after the ultrasound to review the results and for further recommendations. With complaints of persistent pain, a recommendation was made to consider surgery, with the options presented for laparoscopic removal of the right ovary, both ovaries, a laparoscopic total hysterectomy with bilateral salpingo-oophorectomy (LAVH-BSO), or an abdominal approach to these procedures. Options including a CA125, frozen section of the ovary at the time of surgery, and oncology backup were discussed at this appointment. Surgery was delayed for better diabetes control. 


	The patient was seen 2 months later for a preoperative appointment by the chief resident and attending who would perform the surgery. The preoperative diagnosis was chronic pelvic pain unresponsive to medical therapy, and a right adnexal mass, most likely a dermoid of the right ovary. It was noted the patient wanted only removal of one or both tubes and ovaries and preferred to avoid hysterectomy. The attending’s note specifically documented her history of 5 prior C-sections; the possibility of conversion to laparotomy; the need for a bowel prep; the increased risk of bowel, bladder, vessel, or ureteral injury; and the potential need for surgical consultation and multiple surgical procedures. 


	The patient underwent surgery 10 days later. A note documented the patient’s continued consent and desire to proceed with surgery. Findings included extensive adhesions of the omentum and uterus to the anterior abdominal wall. There were extensive adhesions of the bowel to the right and left ovary. Extensive adhesiolysis and BSO were performed. The procedure took approximately 2½ hours. The operative note performed immediately after surgery documented entry via the Hasson method. Also documented was lack of suspicion or clinical evidence of inadvertent injury to bowel, bladder, major blood vessels, or the ureters. The surgical note specifically documented that adhesiolysis was performed with laparoscopic scissors without use of energy. At the end of the surgery it was documented that all areas of surgical treatment were inspected with no evidence of bleeding or inadvertent injury identified. Blood loss was estimated at 50 cc. The patient was observed postoperatively with no untoward or unexpected post-operative findings. She was discharged home the day of surgery to be followed as an outpatient. The final pathology confirmed a 6.5-cm benign cystic teratoma with a segment of a normal fallopian tube. The left ovary revealed endosalpingiosis and a normal left tube. 


	The patient was called by the involved resident the day after surgery, as was the routine practice in this department. The patient reported she was doing well. However, over the next 4 days, several calls were made by the patient’s family stating she had continued complaints of pain and abdominal bloating. It was documented that at each call the family was advised to bring the patient to the emergency department (ED), either by their own transportation or via ambulance. However, there were some inconsistencies in the documentation, or lack thereof, of phone calls received from the patient’s family and the advice given. Ultimately, 6 days after the original surgery the patient was brought to the emergency department by ambulance for abdominal distension, constipation, and severe pain. She was seen by a partner of the original attending and by general surgery. Surgery admitted the patient to the hospital for surgical exploration for a bowel perforation and fecal peritonitis, with repair (over sewing) of the perforation and colostomy. On the day following the initial surgery to repair the bowel perforation, the physicians/surgeons and the hospital’s director of risk management met with the patient’s family to review the original surgery, the ensuing complications, and the expected course in recovery. They entertained any and all questions from the family. A hospital representative was assigned to the family to assist in their “navigating” the hospital areas and to be a consistent point of contact for the family. 

The attending gynecologist asked the pathologist for a re-review of the original surgical specimen, particularly looking for bowel serosa in the specimen. The addendum stated that the findings are consistent with the original diagnosis of a cystic teratoma. No bowel was found on the ovarian surface or in the surgical specimen.

During the ensuing 4 months of hospitalization, the patient underwent 5 additional surgical procedures, spent 2 weeks in the surgical intensive care unit, had 3 months of rehabilitation and physical therapy services, and required readmission twice for gastrointestinal bleeding. During her hospitalizations the original attending gynecologist initially saw the patient daily, then every other day, and weekly thereafter, with brief notes documenting his visits in the patient’s record. At the time of the patient’s subsequent readmissions, the attending general surgeon alerted the attending gynecologist, allowing the gynecology attending to visit the patient during those hospitalizations. 


	Suit was filed alleging inadequate preoperative evaluation, failure to obtain a CA125 to rule-out malignancy, failure to obtain an adequate informed consent, inappropriately continuing with a laparoscopic approach and not converting to an open procedure, failure to obtain a frozen section, failure to identify the bowel injury at the initial procedure, and that the care rendered was a substantial departure from physicians with the same level of skill as the attending gynecologist and resident.


	In preparation for litigation, at the request of the defense attorney, the attending surgeon prepared a summary of the case, addressed anticipated areas of concern, and provided justification for the treatment rendered, supportive documentation, and pertinent literature. The attending surgeon also provided documentation of his extensive experience in performing similar cases, as well as ultrasound expertise. This information was used to prepare the response to plaintiff interrogatories and case defense. 

The defense attorney sent the case for review to an outside expert of comparable expertise. This gynecologist supported the surgical approach to this patient, the surgical technique described in the operative note, and management of the complications. 

The patient’s deposition revealed several key factors for the defense: 

The patient remembered the attending reviewing the operative procedure and its risks in the preoperative holding area; 

She remembered the gynecology attending holding her hand when she went to sleep and saying, “We will take good care of you;” 

She remembered the physician speaking with her prior to her discharge from the postoperative unit;  

She remembered the attending coming to see her in the hospital on a number of occasions during her subsequent hospitalizations. 

All of these statements supported excellent communication and demonstrated the caring demeanor of the gynecologic surgeons. The defense attorney felt this would be critical in “winning over” the jury. The defense attorney also secured an admission by the plaintiff’s husband that he had been advised to immediately bring the patient to the emergency department. The lack of their coming to the hospital immediately, with the ensuing delay in diagnosis, contributed to the adverse outcome of the patient.

Deposition of the plaintiff’s expert revealed a lack of experience in complicated laparoscopic procedures. Criticism regarding the lack of an adequate preoperative evaluation was countered with the imaging diagnosis of a dermoid on both ultrasound and CT, supported by the pathologic findings. Criticism regarding the lack of preoperative CA125 testing was countered by the pathologic confirmation of a dermoid, which did not require CA125 testing. Criticisms regarding the lack of recognizing the bowel injury intraoperatively were countered by the specific documentation in the operative note. 

Following deposition of the plaintiff’s expert, the defense attorney filed a motion to dismiss with prejudice. This means the court has made a final determination on the merits of the case, and the plaintiff is forbidden from filing another lawsuit based on the same grounds. The plaintiff’s attorney did not object and thus, the case was dismissed with prejudice. 


	Bowel injury cases at the time of laparoscopy, whether conventional or robotic, present significant challenges, particularly since patients suffer significantly, particularly if there is a delay in diagnosis. Juries sympathize with these patients, regardless of the merits of the case. The literature demonstrates that many, if not most, bowel injuries are not recognized at the time of surgery. Thus, early recognition is crucial in optimizing outcomes. In this case, the communication between the physician’s practice and the patient’s family, although not ideal in documentation, demonstrated a valid attempt to assess the patient’s clinical status. Further, the patient’s delay in presenting to the hospital contributed to the more severe outcome in this instance. 

The fact that there were documented attempts at medical management of the patient’s pain, and that the gynecologists did not immediately move to surgery, while addressing her other medical conditions, demonstrated a thoughtful approach to the patient’s care. 

The documentation of informed consent was excellent in this case. Informed consent requires a discussion of the probable diagnosis, the options in management, including doing nothing, and the substantial risks of surgery. All of these areas were specifically addressed in the documentation. Of note, the attending’s note again confirming the patient’s understanding in the preoperative area further helped negate a claim of inadequate informed consent. Also of note is that this department schedules their preoperative clinics so that, in most instances, both the resident and the attending who will be performing the operation meet the patient prior to surgery. This allows for establishing rapport and trust with the patient and her family. This remains a particular challenge in many residency programs, particularly as residents who performed the preoperative evaluation may rotate off the service. 

It was critical that an operative note was completed immediately following the surgery documenting the surgeons concern for and efforts to avoid and identify a bowel injury. Had this note been entered after the diagnosis of a bowel injury, it would have been discredited by a skilled plaintiff’s attorney. Conversely, a note entered contemporaneously supports the prudent actions of the surgeon. 

Attending presence in a teaching hospital environment

The documented attending involvement in this case, both for the gynecology service and the surgical service, is commendable. This involvement laid the foundation for the defense of the patient’s care. The documented training and surgical experience of the attending gynecologist was critical in defending the surgical approach in the case. 

The communication between the surgery attending and the gynecology attending allowed for continued involvement of the gynecology attending, even on subsequent admissions. This continued involvement, particularly in the presence of major complications, demonstrates a caring approach which is embraced by a jury.

Involvement and support of the hospital’s Risk Management department

This particular institution takes an aggressive approach to communicating with patients and their families, bringing together the involved providers and the patient and her family. Transparency regarding the patient’s care, the concerns of both the family and the physicians, and openness to questions from all parties enhances communication and trust. Often, patients and their families just want honesty and are less apt to pursue litigation if they feel they are being truthfully informed regarding the patient’s care and treatment. The additional support of a patient liaison for the family is always welcome and appreciated by the family, particularly those unfamiliar with a hospital system or coming from long distances for care. 

This attorney asked the gynecologist to prepare a summary of the case, all foreseeable claims, and potential defenses, and supportive literature. Since this information was prepared at the defense attorney’s request, in most states, this information is protected by attorney-client privilege. The ability of an attorney to anticipate the claims and have a prepared answer is crucial in litigation. Although difficult, it is important to notify your attorney of concerns that may have little or no defense, so adequate preparations can be made to address these concerns and mitigate their damage. The information provided by the physician at the attorney’s request allowed the defense attorney to anticipate every claim levied at deposition and negate the validity of the claims. Attorneys prefer to be over-prepared and avoid surprises during deposition and trial.

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Electronic records are ubiquitous. Whether confined to one provider or group’s record of a patient’s care, the electronic medical record (EMR) or the comprehensive record of a patient’s entire care, the electronic health record (EHR), are now the standard for documenting a patient’s care. The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 authorized grants and incentives totaling an estimated $28 billion to promote “meaningful use” of EHRs by providers.

 In recent years, EHRs have become somewhat more user-friendly, allowing customization to enhance efficiency and access to critical information in a patient’s record. The benefits are tangible, but new risks with EHRs are becoming evident. 

EHRs offer opportunities. With them, there is no question that records are legible, a significant improvement over hand-written accounts. When EHRs are complete, they enhance the quality of patient care and potentially reduce errors. Access to a patient’s complete history allows all treating providers to coordinate care and communicate about the patient’s care. EHRs offer rapid access to imaging studies, laboratory findings, pathology, and outside records, improving efficiency and care coordination. Better documentation of clinical decisions and activity, through both user-entered data and metadata, may improve the ability to defend against malpractice claims when care was appropriate. Automatic alerts warn physicians about a patient’s allergies, potential harmful drug interactions, and caution about use of medications that may be contraindicated based on a patient’s medical conditions. Care pathways offer consistent, evidence-based guidelines to enhance care and minimize complications. Ultimately, universal access to care wherever a patient is seen would markedly enhance efficiency and quality. 

EHRs also present new challenges and risks. Liability can be increased based on inherent designs. Templates bring in data and assessments that may not have been performed or reviewed. Copying and pasting potentially propagates errors in documentation. Many “assessments” in EHRs merely list the diagnoses associated with the visit. Failure to document one’s thought process, assessment of the potential causes of the condition, and a thorough differential diagnosis reduces defensibility (Kevin J. Kuhn Esq., Wheeler Trigg O’Donnell LLP, Denver, Colorado, personal communication, June 22, 2018). 

Most juries understand physician judgment. Unfortunately, documentation in EHRs may not reflect this judgment. The ability to access all facets of the patient’s care could create a duty to act on the information. Even worse, metadata will document if the provider reviewed critical documentation found elsewhere in the record. Deviation from care guidelines and clinical-decision guidelines may bolster the plaintiff’s case. Academic environments add an additional risk, as attendings must attest to the assessment and treatment plans of trainees. It is incumbent on the attending to read the entire note and ensure that all facets of the documented exam were performed, assessments are complete, and treatment plans appropriate. Failing to adequately review the documentation can expose the attending to liability. 

What is metadata? In short, it is data about data. Both EHRs and EMRs automatically generate a time stamp that documents who accessed the document, what was accessed and when, where access occurred, and even how long someone was in the record. 

Physicians facing a suit may be tempted to review the record and clarify some salient points. That is fraught with much risk, particularly in the era of EHRs, with their inherent metadata. Today, it is not enough to defend just the medical record. Now one must defend the metadata. 

An audit trail is metadata that records who, when, where, how and sometimes why a person accessed a patient’s medical record. Typically, the identity of the user who accesses the patient’s record, the time of access, the terminal or device used for access, the action taken by the user (i.e., viewing the record, changing the record), and the substance of anything added to the record and any changes or corrections made by the user are recorded in the metadata, which can be reproduced in the form of an audit trail or log.

 To emphasize the level of detail available, one study by a surgery department assessed preoperative review of computed tomography scans.

 The researchers were able to determine which residents accessed the record, whether just the report was viewed, if the images were viewed, how many images were viewed, and for how long. The authors found that senior residents viewed more images than junior residents or family medicine residents. 

Of note, an audit trail only records who is logged into the computer. Thus, if an attending reviews the images with a resident who is logged in, the audit trail will not reflect that the attending viewed any images. The authors recommended that the attending login separately to view imaging studies and laboratory results to provide electronic confirmation of his or her involvement in a patient’s care. Without such documentation in the metadata, a rebuttable presumption is that the surgeon never looked at the images. 

In an obstetrical case with an adverse newborn outcome, the nurses’ records document that Dr. X was notified of late decelerations. Shortly thereafter, the nurses again documented that they notified Dr. X of late decelerations. Dr. X testified that he reviewed the fetal heart rate (FHR) monitor remotely and the decelerations were not ominous. Metadata demonstrated that Dr. X failed to review the FHR recordings, even remotely. Remember, metadata shows who accessed the EHR, when and where. Dr. X’s credibility was severely damaged. The case was settled for an undisclosed amount. 

Unnecessary hysterectomy with complications

A patient underwent a laparoscopic hysterectomy and suffered a bowel injury. The liability action included a claim of performing unnecessary surgery. At deposition, the surgeon testified that he had fully reviewed all studies in anticipation of the surgery. Multiple experts were deposed supporting the indications for hysterectomy and the surgeon’s performance of the surgery. 

A subsequent audit of the metadata, however, demonstrated that the surgeon did not access the studies until after the suit was filed. Further, it demonstrated that the surgeon had not reviewed pertinent lab results prior to surgery. Even worse, the surgeon altered the record to justify the surgery, with the timing of the alteration found in the metadata. The credibility of the surgeon’s testimony was destroyed, he committed perjury, and the case settled. Further, sanctions were filed against the surgeon because the expert depositions were based on fallacious information. The surgeon paid $90,000 in restoration of the plaintiff attorney’s expenses and is facing possible loss of his license by the state board of medicine. 

How common is alteration of the medical record? One plaintiff’s attorney estimated that 25% of cases involve alteration of the medical record (Personal communication, anonymous plaintiff attorney, June 20, 2018). As such, an audit trail expert is hired for every case. This expert examines the digital footprint of record, determining if there have been deletions, alterations, or modifications to the record. This has resulted in settlement of a number of cases-particularly if the modifications occurred after litigation began-that perhaps otherwise would have been defensible. Experts in metadata also advise the attorney on questions to ask to establish this type of evidence. 

An EHR has the ability to generate templates for specific diagnoses or symptoms, which can be convenient and efficient. But errors in data entry can be propagated by copying and pasting. When discovered, a “correction” should be made. Corrections are changes in a patient’s medical record during the normal course of treatment.

 A change made prior to the issue of a claim or lawsuit would be considered a correction. Corrections are acceptable provided they are made appropriately. 

Institutions and practices should establish a policy for appropriate medical record corrections. Typically an addendum is made to the medical record, denoting the date, time, and author of the correction and the reason for it.

 Striking through the erroneous entry with a single line is preferable. If appropriate, attention should be directed from the erroneous entry to the corrected entry. Once the correction is made, the erroneous entry should not be removed or deleted because it may have been relied upon by other health care team members.

 Removing or deleting such data alters the integrity of the medical record. Authorized and transparent alterations are considered a testament to the medical record’s accuracy, freedom from unauthorized alterations, and completeness.

 When done appropriately, these corrections will not be construed as altering the medical record. 

In contrast, an “alteration” is when a provider receives a notice of suit and then goes to the medical record to “clarify” certain points, particularly for the purpose of aiding defense of the claim. Such alterations are considered a deliberate misrepresentation of the facts. Discovering such alterations during litigation severely impacts the ability to defend a claim. Further, many liability policies exclude coverage for claims in which the medical record was altered. Providers must not alter the medical record after receiving notice of a claim. In addition, after receiving notice of claim, physicians should refrain from accessing the medical records without first speaking with their liability carrier or legal counsel. Such access infers the possibility of record alteration. 

EHRs offer great benefits with some potential new areas of liability. However, proper and timely documentation enhances the defense in liability actions. Metadata will become the standard when integrity of an EHR is questioned. “Metadata is evidence, typically stored electronically, that describes the characteristics, origins, usage and validity of other electronic evidence.”

 According to one attorney, “Metadata is discoverable evidence that our clients are obliged to preserve and produce. Metadata sheds light on the origins, context, authenticity, reliability and distribution of electronic evidence, as well as providing clues to human behavior. It’s the electronic equivalent of DNA, ballistics and fingerprint evidence, with a comparable power to exonerate and incriminate.”

 A special thanks to Kevin J. Kuhn, Esq., a defense attorney with Wheeler Trigg O’Donnell, LLP, Denver, Colorado, for his insight and defense perspective on electronic health records. Also, a special thanks to the anonymous plaintiff attorney for his perspective on metadata and the use of audit trails in litigation. 

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Meyer J, Tomes J, Neubecker L. Electronic medical records: metadata as evidence in litigation. Ill Bar J. 2013;101(8).

McLean T, Burton L, Haller C, McLean P. Electronic medical record metadata: uses and liability. J Am Coll Surg. 2008;206:405-411.

Ryan M-L. Making changes to a medical record: corrections vs. alternations. NORCAL Mutual Insurance Company. 1-2. 

http://www.sccma-mcms.org/Portals/19/Making%20Changes%20to%20a%20Medical%20Record.pdf

Samaritan G. correcting ehr erros without getting into trouble. Medscape. 2013. 

https://www.medscape.com/viewarticle/804731_print

Norton C, D’Amico M. The Electronic Medical Record, Audit Logs and Revision History. 

www.damicopettinicchi.com/scholarly-articles/the-electronic-medical-record-audit-logs-and-revision-history.html

Ball C. Beyond data about data: the litigator’s guide to metadata. 2005. 

http://www.craigball.com/metadataguide2011.pdf

Metadata from an EHR form an audit trail of activity, which can make or break a malpractice case.

James Shwayder, MD, JD

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