As plaintiffs’ attorneys become more adept at gaining access to previously protected risk management information, HRMR explores the value of clear procedures for protecting medical records and the need to adhere to the facts.
A growing problem faced by risk managers in hospitals and other healthcare organizations is the tendency for plaintiffs’ attorneys to win access to risk management information long considered protected and internal—including documents pertaining to investigations of incident reports and unanticipated outcomes.
In a recent example, a judge instructed a hospital to hand over internal risk management materials to the patient’s lawyer. While the hospital argued the materials were protected, the judge ruled it was within the (now deceased) patient’s right to seek them.
Procedurally, the hospital did exactly as expected—it filed a motion to quash the subpoena and complained that the materials were protected. The judge, however, evaluated the materials and decided several pieces of information must be disclosed to the patient. These materials include a doctor’s report on how he had missed a radiologist’s recommendation to check for possible cancer.
“The troubling implication for risk managers is that fact-gathering as a result of an incident or other problem associated with potential patient harm may indeed be subject to disclosure—up to and including a risk manager’s handwritten notes taken in the course of discussions with those involved,” says Donna Foster, an attorney with law firm LeClairRyan.
Similarly, a May 2014 ruling from the Circuit Court of Hampton highlights the potential discoverability of electronic medical record (EMR) audit trails and metadata. In the Hampton opinion, Judge Christopher W. Hutton wrote: “There is no dispute, and it is well settled, that medicine has long past evolved from that time when ‘a patient’s chart’ was a clipboard hung on the foot of a bed.”
In addressing the plaintiff’s attorney’s request for the defendant hospital’s policies and procedures, Judge Hutton’s opinion came down on the side of “an inexorable march to more disclosure”.
“This is not a Virginia-only concern,” says Foster. “Case reports suggest these procedural tactics are becoming more commonplace in medical malpractice cases across the country—especially in the long-term health litigation arena.”
A new age
How are plaintiffs’ attorneys managing to access such information? Patrick Hurd, also an attorney with LeClairRyan, believes there are three key factors.
One is the rapid growth in use of EHRs.
“Healthcareproviders’policiesand procedures regarding access, data input/output, documentation, etc, with EHRs are derivations of those established during the paper record years rather than new policies and procedures focused on the extraordinary amount of data and information now available with the push of a button,” he says.
“Courts (and judges) are ill-equipped to understand and embrace the complex legal and technical issues posed by EHRs and often find it difficult to define the medical record and the limits on access to the hitherto privileged information they contain. Many err on the side of giving plaintiffs’ counsel greater access to ‘serve the ends of justice’.”
There is also a growing trend in medical malpractice litigation of focusing more on the absence or presence of someone ‘in the EHR’ via an examination of the metadata/audit trail as an evidentiary basis for showing provider negligence rather than the actual patient care plan, therapies and treatments provided given the diagnoses, history and physical examination, co-morbidities, etc, of the patient.
“Plaintiffs’ counsel use these broad discovery requests and the battle over granting access to such data as leverage to compel settling what might otherwise be litigable claims,” says Hurd.
Also significant, he adds, is the fact that the shift from fee-for-service to value-based purchasing/ pay for performance in healthcare mandates greater documentation of unanticipated outcomes and extraordinarily detailed analyses of opportunities for improving quality and safety.
“Although federal and state statutes attempt to provide privileges/protections for such data, plaintiffs’ counsel are finding success in arguing that much of that data is ‘kept in the ordinary course of business’ and thus under judicial precedents (established in the paper record days) required to be produced in medical malpractice litigation.”
A process issue
Judy Selmeci, an attorney with New York law firm Wilson Elser, agrees, saying that in New York, even when a document is protected from disclosure by the quality assurance privilege, it can still be subject to disclosure if the information is not processed properly.
“If the process is compromised and it is disclosed—for example, it’s given to the patient, or to somebody else—then you’ve waived the quality assurance privilege. The reasoning is if you can give it to one person, you can give it to the plaintiff—and you may be ordered to turn it over under those circumstances.
“This is a process issue—it’s a matter of a risk manager putting in place the processes to ensure that when you write that document it is for the quality assurance committee, it goes to the quality assurance committee and it stays there.
“You have to be aware that you’ll have a nurse or somebody relatively low on the rungs involved in creating it and it will have to travel all the way up the chain. It has to go through lots of hands, but if you have the process in place and everybody understands the function of these documents, then you are able to preserve the privilege.”
Foster agrees that it is vital to get the procedures right. “For starters, training, policies and procedures should be organized around the mantra ‘stick to the facts’. While the likes of mental impressions, conclusions, opinions or legal theories can be redacted (as they were by Judge Pugh in the Newport News case), you cannot assume that they will be redacted.
“If the purpose of an investigation is to gather facts in the wake of an incident, then the training, policies and procedures should stick closely to that purpose, never straying into matters of conjecture or opinion.”
“It has to start with training,” agrees Selmeci. “Once you put that system in place it should start with your nurses coming through the door—they should be trained to understand the point of the form they are filling out, why are they doing it, where it will go, what will happen to it.
“The people who are on the quality assurance committee are probably higher up in the chain so they may know this, but the nurses may not.
This material is to all intents and purposes secret and you have to treat it that way—and the risk manager should know it, and should have the systems in place along with the methods to teach everybody within the organization how to ensure that the privilege remains.”
Stick to the facts
Foster says that when making statements, doctors should be reminded of the need to stick to the investigative facts. Next, review all policies and procedures to ensure a clear demarcation between fact-gathering regarding claims or potential claims and review/analysis related to opportunities for improvement of quality care and patient safety.
“Healthcare organizations must preserve their ability to take factual information and place it in the hands of quality review organizations,” she says. “This process necessarily involves evaluating, assessing and even opining about how changes in policies, procedures, processes, training, education and credentialing could improve patient safety and quality of care.
“Plaintiffs’ attorneys will continue to ‘go after’ such privileged information. However, the industry must fight back. Fortunately, many judges recognize the importance of privilege to the quality assurance process.”
Hurd adds that risk managers should take care to avoid extreme reactions to this trend. It is impossible to evade the discoverability of factual information by never writing anything down at the start of an investigation.
“Indeed, under Virginia law ‘oral communications regarding a specific medical incident involving patient care, made to a quality assurance, quality of care, or peer review committee ... shall be privileged only to the extent made more than 24 hours after the occurrence of the medical incident’,” he notes. In other words, a fact-finding inquiry conducted in the immediate aftermath of an incident is not necessarily protected simply because entities related to quality assurance were involved and because nobody wrote anything down.
“Likewise, formal or informal policies that encourage people to say as little as possible—to ‘clam up’—are highly counterproductive. Indeed, some risk managers go so far as to refuse to talk to quality assurance entities out of a desire to avoid tainting the quality review process. But how can the integrity of that process be protected without access to information?” he says.
Foster’s final recommendation is to maintain a sharp focus on consistency, clarity and objectivity when reviewing policies and procedures, and in light of the potential for discoverability, to reconsider questions such as:
•Who will investigate or be part of the investigation?
• When should the investigation start?
• Do you need to confer with counsel?
• What documents will be generated?
•How will you maintain that line of demarcation between the investigation and processes related to learning from mistakes with a view toward maximizing patient safety and quality of care?
As plaintiffs’ attorneys become more savvy at gaining access to risk management records, the challenge is to ensure that lessons are learned from an incident by protecting the confidentiality that allows for honest reporting and analysis.
“The point of the process is to know what happened,” says Selemci. “If you have the secure knowledge that what you do here is privileged then you will have a greater degree of success.”
Donna Foster, LeClairRyan, Judy Selmeci, Wilson Elser, US