EXECUTIVE SUMMARY
It is crucial to secure evidence after any event that may lead to litigation. This includes physical evidence of many types, and digital records.
- Lock down the chart immediately.
- Retain placentas after an injurious birth.
- Preserve scraps of paper with hastily written notes.
An adverse event that could lead to litigation or investigations should prompt risk managers to implement a prepared process for securing the related evidence, which can take multiple forms. Properly obtaining and protecting the documents, devices, witness reports, digital data, and other evidence may determine the outcome of future litigation.
One of the first priorities must be preserving the medical record, says Jason B. Hendren, JD, partner with Hall Booth Smith in Rogers, AR. After any adverse event, risk management must lock down the chart quickly.
“You can’t have doctors, nurses, or anybody else jumping in there once they become aware that there’s been a problem. Physicians are very concerned any time a patient has a complication, and their gut reaction is to go back and see if they missed anything, or what they said about some issue,” Hendren explains. “They may not mess with the chart or change anything, but the plaintiff’s lawyer will make it sound like they felt guilty, they wanted to go back in, and they might have been tempted to add or subtract or do something else.”
Clinicians should be told to speak with risk management before filing any kind of addendum to the chart, Hendren says. Even if there legitimately is some additional information that clarifies the care process, it usually is better for the clinician to just explain what is in the chart rather than adding an addendum. The clinician also can state that they remember other details not in the chart that are relevant considering the adverse outcome, but which were not relevant to chart at the time.
Preservation of physical and clinical evidence also is important. Hendren has seen many cases alleging a birth-related injury in which the placenta was not preserved, even though it can be critical in determining the nature and timing of the injury. Risk managers often tell Hendren that they keep the placenta for a few days or a week and unless the physician orders it sent to pathology, the hospital discards it.
“That’s usually a problem, because if nothing else, it can show pertinent negatives,” Hendren says. “I would say any time you have a birth-related event, the risk managers need to strongly encourage that placenta to be maintained and sent to pathology for examination.”
Hendren also urges risk managers to focus on the widespread use of text messaging and group chats. He has seen several occasions in which labor and delivery or ICU nurses were discussing a patient on a secure group chat, and those communications usually do not end up in the chart.
Those communications can be helpful. They may reveal efforts or concerns not clearly documented in the chart, and they can pinpoint when a nurse called a physician for help, Hendren says. The risk manager should quickly round up any phone that might have been used to send a text message or make a call because obtaining phone records five years later when litigation begins can be much harder.
Another issue arises during codes, rapid responses, and other emergency situations. In a fast-moving situation, clinicians often will chart on scratch paper, paper towels, their lab coats — anything handy — and then transfer that information to a code sheet or to the nursing notes later.
“Sometimes, that stuff is just thrown in the trash, and there have been occasions where we all would have really liked to have seen that because what actually gets into the chart isn’t totally accurate or complete,” Hendren says. “I’ve got a case where I’m dealing with a very lengthy code and resuscitation effort that went on for several hours. All that stuff was just being written down on the fly and then transferred later that day or the next morning on to the actual chart. But they had the presence of mind to save those scratch pieces of paper. That was very helpful, because it helped fill in some gaps.”
Blood transfusions are a similar situation. When blood units are brought for the transfusion, nurses must peel the identifying tags off, and they usually just stick them on a scrap piece of paper. When they transfer the information to the chart, they just write the number that was on the tag.
“But it’s more compelling when you actually have the scratch paper and you can say, ‘Here’s when unit four went in, and that’s the tag number,’” Hendren explains. “Risk management can say, ‘I want everybody to save every scrap of paper — everything — because it’s going to be asked for. People are going to ask if you knew this was going to be potentially a lawsuit, why didn’t you save all that stuff?”
Litigation hold letters must be taken seriously, Hendren notes. When a plaintiff attorney issues a hold letter to preserve certain documents, there is no wiggle room in complying. A notable Arkansas case involved a plaintiff attorney requesting the patient’s chart be preserved. The hospital complied for a couple years but then scanned the chart and destroyed the original, leaving only the digital record.
The plaintiff’s attorney protested that the hospital did not preserve the chart as ordered, saying they suspected there were sticky notes and other items not scanned. The hospital’s answer was stricken for spoliation of evidence or losing or destroying evidence, Hendren says.
Prepare Policies Now
Healthcare providers must be prepared in advance to ensure that policies and procedures are readily available for securing evidence, says Richard F. Cahill, JD, vice president and associate general counsel with The Doctors Company, a malpractice insurer based in Napa, CA.
Statements of witnesses should be prepared as soon after the incident happens as practicable to enhance accuracy and reliability.
“Such materials should be labeled clearly as either an ‘incident’ or an ‘unusual occurrence report,’ with a notation [indicating] that the document has been ‘prepared in anticipation of litigation at the direction of counsel,’ thereby triggering statutory and common law attorney-related privileges and protecting the content from subsequent disclosure during litigation,” Cahill explains.
Materials generated at the request of counsel should not be placed or scanned into the medical record, Cahill says. Access should be limited only to hospital or clinic lawyers, or appropriate senior administrators tasked with overseeing quality assurance or risk management responsibilities. Practitioners should be cautioned that witnesses should not directly review their statements in preparation of deposition or trial testimony, or the privilege from discovery may be lost.
The finders of fact in administrative hearings, civil and criminal trials, and arbitrations routinely scrutinize all available information, which may include tangible physical evidence, such as medical records (hard copy or electronic), X-rays, tissue blocks or slides, and medical instruments or devices that may have malfunctioned during a procedure.
“The integrity of the evidence must be preserved until the matter has been fully and finally concluded, ensuring that the chain of custody is carefully maintained and documented. Best practices dictate that such materials be sequestered as soon as possible in a secure environment, preferably in a locked metal cabinet with limited access” Cahill says. “A log should be kept detailing who has accessed the evidence, when, and why.”
Circumstances that impair the veracity of an exhibit may result in a claim of spoliation by counsel for the opposing party, which may have catastrophic results for the responsible party. This may include an instruction to the jury that an inference may be drawn that the information in question was detrimental to the defense or would have been favorable to the patient if made available.
“Subsequent explanations of what happened by counsel during the trial or other legal proceedings are invariably difficult to prove and often result in a verdict supporting the plaintiff,” Cahill says.
Staff Turnover Can Complicate
Generally, there are two ways in which an adverse event finds its way to a risk manager’s desk — either by incident report by personnel or by family grievance, notes Christina C. Huston, JD, LLM, an attorney with Wilson Elser in Houston.
When there is an immediate report of an event, the facility should enact a specific procedure that should be well-known to all personnel present, Huston says. Unfortunately, the proliferation of agency personnel and traveling nurses makes that an unlikely situation.
“Supervisors present immediately following an event should separate each person involved in the event to avoid a collaboration of the memory of those persons preparing reports. For agency or traveling personnel, these persons will likely require additional instructions to make sure that they are following the facility’s procedures,” Huston says. “It is imperative that incident reporting is not made a part of the medical record. Best practice is an established and designated system entirely outside the medical record with a protocol that no information is copied verbatim from the medical record to the report and no information is copied verbatim from the report to the chart.”
Adding to the complexity is that some states (e.g., Texas) recognize incident reports as privileged documents while other states (e.g., Florida) have limited privilege if they pertain to medical malpractice incidents. Many states (including California) lie somewhere in between, Huston explains.
Assuming the incident reports are privileged, Huston says the best practice is to follow these steps:
- Separate personnel;
- Do not share information verbatim from the medical record to the incident report, or vice versa;
- Each person should report only their personal knowledge or information told specifically to them (e.g., a bedside report);
- The information should be entered into a designated system meant for incident reporting and for review by those persons who are either reviewing it in anticipation of litigation or for the purposes of quality improvement or similar peer review committees.
Save Video Evidence
Video statements after the incident are strongly discouraged, Huston says. However, there is probably video of the unit — and perhaps the event.
Most facilities retain video showing anything on the unit that is pertinent to what personnel were doing, such as everyone running to the other end of the unit, suggesting there was an emergent event that was time- and attention-consuming.
“Video will also likely clarify the medical record because one of the most prevalent issues in medical record charting is that it is not contemporaneous and the times recorded are wrong, sometimes by minutes and sometimes much longer,” Huston says. “Sometimes, mere minutes make a huge difference.”
Video should be downloaded, unedited, and stored in risk management or the office of legal counsel immediately, Huston suggests. Almost all facility video will disappear from the system within days. Even video that is saved to the cloud by operations likely will be overwritten eventually.
“Do not depend on security or operations people to maintain the integrity of video that may be demanded in discovery later,” Huston says. “While post-event photographs of a unit or video of the unit can be helpful to a later investigator unfamiliar with the layout of the unit, they should be completed only by an individual tasked with gathering information in anticipation of litigation.”
Another area where information disappears quickly due to overwriting is electronic badge entry to the unit or between units. Consideration should be given to whether this information should be gathered for review in the investigation, Huston notes.
Interviews Better Than Statements
Handwritten statements from those involved or present during the incident are not ideal.
“In truth, I prefer an interview by a risk manager or legal counsel — or even an experienced legal assistant — to any written statements,” Huston says. “Counsel’s notes in anticipation of litigation are much easier to protect than a document written in the personnel’s handwriting that can be argued as a witness statement required to be produced in subsequent litigation.”
Personnel must be questioned as to how they chart, Huston says. Noncontemporaneous charting is not negligence, but if the chart identifies a different entry time than the time care was provided, it is important for an investigation team to know that.
For more serious events in which litigation is anticipated, review the video and compare it to the medical record regarding timing of chart entries, Huston advises. Medical records should be locked down within a reasonable time.
“Most facilities will have a policy that medical personnel should update medical charts no later than their shift end or within 24 hours,” Huston says. “Changes to a medical chart past the facility policy can be devastating to a defense. The probability of an audit chart being requested, ordered to be released, and reviewed by plaintiff’s counsel is high.”
Lock Down Equipment
Tag and lock down any equipment used on the patient until cleared by legal. Huston notes these examples from litigation cases of equipment alleged to have caused injury or provided inadequate or wrong information: a blood pressure cuff, pain medication delivery systems (pain pump), breathalyzer, fall prevention bed alarm, bedside vitals monitoring equipment, and automated external defibrillators, including calibration and maintenance records.
“It should not be surprising that often none of this equipment is still available by the time that legal is called into the investigation, nor were serial numbers recorded for easy identification at a later date, which is the second-best option allowing the equipment to stay in use,” Huston says. “Chain of command documentation is always helpful but not necessarily required unless the event is one in which criminal charges are expected.”
Review the personnel files of everyone involved for completion and untimely or missing competencies, review, performance improvement plans, licensure confirmation, and continued education requirements, as well as anything else required by the facility and by state statute, if any, Huston advises.
An additional consideration is whether police or other law enforcement responded to the event. Law enforcement officers often use body cams and audio equipment that may record encounters with clinicians and administrators after an event, so it is imperative that personnel are in the presence of supervisors or, under certain circumstances, legal counsel when questioned by law enforcement, Huston says. Properly train personnel to answer questions as a professional medical team member.
“Questioning by law enforcement is not the time to say, ‘I have never been so nervous in my life,’ or ‘That was the craziest thing I have ever seen,’ or ‘No one knew how to respond to the patient’s crisis,’” Huston says. “It is not a gab session; it is a report that is likely being recorded and will be accessible by subpoena at a later time. In certain circumstances, it may well be necessary that law enforcement is asked to shield body cam and audio recording equipment in any areas where patients or private health information are visible or audible.”
Contact Legal Soon
Upon learning of an event that could lead to litigation, investigation, or regulatory inquiries, risk managers or others should connect with and secure advice from the legal team as soon as possible, says Steven Berrent, JD, managing director with Deloitte Risk & Financial Advisory in Jersey City, NJ.
Whether an event is litigation, internal investigation, or regulatory compliance-related, it is a requirement to preserve any reasonably accessible potential evidence in digital, paper, audio, video, database, or any other form. This is the first step in the process called discovery, Berrent explains.
Generally, photo or video copies of evidence are not necessary, beyond preserving evidence that will not remain as-is in its current state or environment, Berrent says. For example, the physical evidence from a structure, object, device, injury, or damage is likely to change over time. Consultation with counsel should consider who should create those photos or videos of physical evidence, because it is possible the individual may be subject to questions through testimony. The details of time, place, and circumstances should be tracked contemporaneously with the photos or video.
Evidence should be maintained such that it will be preserved and not deleted or discarded. For example, paper or other physical evidence should be segregated into protected areas so it is not inadvertently discarded or deleted as part of the normal course of business.
When data are collected in the second phase of the discovery process, maintaining a chain of custody is a standard best practice, Berrent notes. By maintaining a clear chain of custody, a record is made of the source of the data, the time at which it was collected, and all the individuals who took possession of the data. Chains of custody in discovery can help answer questions on data provenance or completeness as well as to answer questions on evidence authenticity in a court or other legal forum.
Upon detection of an event that could lead to litigation, investigation, or regulatory issues, it is crucial to prioritize involving appropriate legal counsel, IT, and records stakeholders, making sure the full scope of the obligation to preserve evidence is understood by all possessors of data, and preserving all necessary data, regardless of their form or source.
“The key is to engage your legal and technology teams to advise you on your legal obligations in the context of your organization’s technology and infrastructure,” Berrent explains. “Failing to properly preserve and collect evidence can result in court sanctions that can be costly and increase the likelihood that your organization will lose the dispute.”
Protect Patients First
After a medical error or adverse event has been identified, the healthcare facility’s risk management team must immediately take action to eliminate any obvious remaining threat to patient safety, such as an impaired provider, faulty equipment, an unsafe system of care, or a deficit protocol, says Christopher E. Brown, JD, partner with Kaufman Dolowich in Orlando. The team should then immediately secure implicated drugs, equipment, and records. Photographs and videos are not recommended, as these are not part of the traditional record and could be used against the facility.
All members of the care team should be briefed as soon as possible so they are fully aware of the issues and ensure all subsequent communications with the patient and family are consistent. The risk management team also should designate a single individual who will carry the responsibility for communicating with the patient or family about the event.
“All communications with the patient and family should be documented, including location, date and time, participants, conversation details, patient reaction, the level of understanding exhibited by the patient, and the next steps to be taken by the patient and any providers or the facility staff,” Brown says.
Although photos and videos usually are not necessary and could be detrimental, there are some exceptions, says Aubrey B. Gulledge, JD, an attorney with Baker Donelson in Memphis, TN. Photos and video should be collected if the appearance of any evidence involved may change over time despite preservation efforts, which could apply to healthcare settings in which some evidence may be impossible to preserve as-is.
“Any time photos or video would capture more accurate representation or visualization of the evidence involved, or a fuller understanding of the facts, they should be collected as close to the time of the event as possible,” Gulledge says. “Relevant physical evidence should be stored securely without changes to its form or contents at the time of the event. If there are any known changes to physical evidence, those changes should be accounted for in a chain of custody document.”
SOURCES
- Steven Berrent, JD, Managing Director, Deloitte Risk & Financial Advisory, Jersey City, NJ. Phone: (201) 630-5046. Email: [email protected].
- Christopher E. Brown, JD, Partner, Kaufman Dolowich, Orlando. Phone: (407) 904-0919. Email: [email protected].
- Richard F. Cahill, JD, Vice President and Associate General Counsel, The Doctors Company, Napa, CA. Phone: (800) 421-2368.
- Aubrey B. Gulledge, JD, Baker Donelson, Memphis, TN. Phone: (901) 577-2218. Email: [email protected].
- Jason B. Hendren, JD, Partner, Hall Booth Smith, Rogers, AR. Phone: (479) 391-6202. Email: [email protected].
- Christina C. Huston, JD, LLM, Wilson Elser, Houston. Phone: (713) 353-2008. Email: [email protected].
An adverse event that could lead to litigation or investigations should prompt risk managers to implement a prepared process for securing the related evidence, which can take multiple forms. Properly obtaining and protecting the documents, devices, witness reports, digital data, and other evidence may determine the outcome of future litigation.
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