Medical/Legal

Prevent, Communicate, Document: Medical Malpractice Data Help Us Manage Risk

David L. Feldman, MD, MBA, FACS, Chief Medical Officer, The Doctors Company and TDC Group

The good news about medical malpractice is that there isn’t very much of it—which is the classic oxymoron of drawing insights from medical malpractice claims to improve patient safety. Nevertheless, medical malpractice data can focus our search for ways to succeed at three key aims of physicians, practices, and health systems: (1) prevent adverse events, (2) prevent lawsuits if adverse events do occur, and (3) prevail in lawsuits when all else fails.

Admittedly, analyzing medical malpractice data comes with obvious downsides. For one, many undesirable outcomes, adverse events, and near misses never result in a claim, so the claim data set, relative to the quantity of care provided that does not proceed optimally (or is perceived as not proceeding optimally) is quite small. And when compared to the total volume of care, it is miniscule. Further, if we wish to study closed claims, we must wait: By the time an event becomes a claim that completes the legal process, it is typically four to five years out from the originating event.

Still, the advantages of medical malpractice claims as a data source are indisputable—and powerful enough to overcome the drawbacks: Relative to alternatives like peer review or root cause analysis, medical malpractice claims provide a much richer source of data. It is a sad yet helpful truth that people bare their souls when they are sued.

Because medical malpractice data have a direct correlation to large sums of money, it is easier to use medical malpractice claim–related findings to drive tangible, system-wide improvements to patient safety that no one wants to pay for.

Prevent, Preclude, Prevail My approach to risk management is the three Ps:

Prevent adverse events. “We can’t fix what we can’t see,” says Dana Siegal, RN, CPHRM, CPPS, director of Patient Safety Services for CRICO Strategies. The Doctors Company employs CRICO’s Comparative Benchmark System when we code medical malpractice claims for our closed claims studies. She continues, “When we view that data across collective and comparative data sets, we validate the repeated patterns and trends across the care system, allowing us to focus resources and improvement initiatives on the most vulnerable risks.”

P. Divya Parikh, MPH, CAE, vice president of Research and Education for the MPL Association, agrees: “Medical malpractice data offer insight into high-risk specialties, medical conditions, and procedures that result in claims, allowing physicians and healthcare systems to direct their risk management programs for safer delivery of care.”

This last point is key—that healthcare systems can and do direct resources to improving patient safety based on insights derived from medical malpractice data—because it is easier to convince large systems to change when they can see not only a patient safety benefit, but also a strong financial incentive.

Preclude lawsuits with good communication. “Communication issues are a great example of the power of studying malpractice data to shed light on the multiple factors contributing to errors and harm,” says Ms. Siegal. When we analyze closed medical malpractice claims across specialties and settings, communication gaps crop up again and again. Those gaps can stem from medical team members miscommunicating with each other or with families. While the former may result in an adverse event (see the first P: Prevent), the latter may result in a lawsuit. A patient’s desire to pursue litigation after an adverse event frequently derives from a misunderstanding about possible outcomes. As a mentor once told me, “When you talk about potential complications before surgery, that’s informed consent. When you talk about them after the procedure, that’s an excuse.” A New York Times article sifted decades’ worth of studies to conclude, “Doctors sued most often were complained about by patients twice as much as those who

were not, and poor communication was the most common complaint.” Note that poor outcomes was not the most common complaint—it was poor communication.

If your institution participates in a disclosure program, follow it carefully when responding to adverse events. A swift, compassionate, effective response to a patient’s needs in the aftermath of an adverse event or undesirable outcome is both ethically superior and practically advantageous for all parties, when compared to a lawsuit as the likely alternative.

Prevail when there are lawsuits via documentation. While undesired outcomes—even those that fall within the realm of a known complication for the treatment or procedure—may motivate patients to sue, it is often poor documentation that motivates a plaintiff’s attorney to take a case. The Doctors Company’s Vice President and Associate General Counsel Richard F. Cahill, JD, addresses this potential pitfall in “The Defensible Medical Record”: Patient grievances may be filed based on an individual’s faulty recollection of events, or a failure to understand the course of treatment or the underlying reason that an adverse consequence occurred. When a medical record is well documented, many allegations are often readily resolved—frequently before a formal administrative process is even initiated.

All of this is otherwise phrased as: Prevent, Communicate, Document

Experience has taught us that patients may bring suit either in the presence of actual medical error or in their perception of medical error. Either way, we have an opportunity to learn how to prevent the next claim. Ms. Parikh summarizes: “Every claim is, in essence, a patient complaint, and therefore an opportunity to learn where improvements can be made.”

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

Open Notes in Healthcare: The Good, the Bad, and the Ugly of the Cures Act

Chad Anguilm, MBA, Richard F. Cahill, JD, and Kathleen Stillwell, MPA/HSA, RN

On April 5, 2021, a requirement of the 21st Century Cures Act went into effect: Patients must be able to access information in their EHRs “without delay.” (This requirement does not apply to paper records.) The Cures Act prohibition against information blocking, often referred to as an “open notes” provision, provides patients with transparency in the outcomes of their healthcare via convenient access to information in their EHR, which can positively or negatively impact the patient-doctor relationship.

Patient access to records is not new, and neither is the Cures Act, which dates to 2016. What is new is the requirement that patients have electronic records access that is fast and easy. This requirement is expected to result in more patients—still a small proportion overall, but more patients—accessing additional EHR information, including providers’ notes.

The requirement to provide patients with EHR access raises questions for healthcare practices. Some questions are logistical, and some are relational. Concerns include the potential for increased time for patient education, or patient requests for changes to their records that the clinician cannot support.

Healthcare providers should understand the good, bad, and ugly implications of the Cures Act open notes provisions so they can meet the requirements and reap their benefits, while avoiding the potential for fines or sanctions based on noncompliance, or other negative impacts. Good News About Open Notes Many patients feel better about their provider after reading a note. Positive effects on the patient-provider relationship may be most significant among vulnerable patients, such as those with fewer years of formal education.

Further, open notes have positive impacts on patient engagement and understanding. Patients report that reading notes is a way to better understand and feel more in control of their healthcare. They also say it builds trust with their provider. The nonprofit organization OpenNotes (not a part of the Cures Act) cites helping laypeople maintain trust in scientific medicine as one benefit of the transparency created by the Cures Act open notes provisions.

Bad News About Open Notes

Concerns about open notes mainly revolve around the potential for conflicts with patients and potential time conflicts.

Concerns include:

Timing: The originally planned implementation date for the open notes provisions in the Cures Act was November 2020. Because of the COVID-19 pandemic, this was pushed back to April 2021. However, many providers and practices are still feeling the pandemic’s effects, leading to the question: “Will new demands never end?”

Uncertainty about the documentation process: Most patients will not understand clinical shorthand, and providers may need added time for explanation. Providers are wondering: “How can I make my notes comprehensible to patients while still writing them quickly?”

Technology: Some EHR vendors are still racing to provide services that allow practices to remain in compliance with the Cures Act. It may be necessary for a provider to call their EHR vendor and say, “What are you doing to ensure my interoperability compliance?” Meanwhile, secure drop box options for records requests provide a workaround.

Ugly News About Open Notes

Some patient requests for record amendment are legitimate and easily handled. Some patients, however, will request removal of material they find embarrassing, even though it is accurate.

More frequent requests for records changes from patients could increase already weighty administrative burdens on providers. Worse, some of these requests will be for changes providers cannot support, and making time for careful conversations with patients and providing written responses for requests that are rejected will be a challenge. Inevitably, some of these conversations will not go well, whether through the patient feeling the provider did not adequately respond to their concerns, or through the patient insisting on unreasonable demands. These negative relationship outcomes will add emotional stress on both the patient and the provider, as well as a reputational threat to providers from angry patients posting negative reviews online.

More tangibly, noncompliance with the open notes requirement carries the potential for fines, penalties, and/ or sanctions from medical boards.

The specifics of potential penalties are not yet known—there are more changes coming with the Cures Act.

Making Changes in Open Notes

Patients will ask providers to amend their medical records. Be familiar with what the patient has the right to ask, what the provider can grant and/or refuse, and how to amend notes. Here are some highlights:

Patients have the right to request amendments to their medical records: The Health Insurance Portability and Accountability Act (HIPAA) requires a signed, dated request from the patient regarding what they want changed and why.

Providers have the right to determine whether the requested amendment will be made: The provider must respond, in writing, within 60 days of receipt of the patient’s request.

Common reasons to deny a patient’s request include that the provider who received the request did not create the record entry, or that the medical record is accurate as is.

The patient’s request and the provider’s response both become part of the patient’s medical record.

Strategies for Success

When composing notes, certain simple strategies will raise the odds that notes will be well understood and well received. Beyond being clear and succinct, strategies for success include composing at least a portion of the note as instructions directly addressed to the patient—“Start taking lisinopril and check your blood pressure twice a week,” vs. “Initiated lisinopril and instructed her to check her blood pressure twice a week”—and providing a list of commonly used medical terms and abbreviations.

For an in-depth review of strategies for success when composing notes, see 12 Strategies for Success With Open Notes in Healthcare: The Cures Act.

Exceptions

Unless an exception applies, clinical notes must not be blocked, but the Cures Act allows for a fairly long list of specific, well-delineated exceptions. For instance, a record can be blocked if a provider believes that viewing a note presents a substantial risk of harm to the physical safety of the patient or someone else. The Cures Act also recognizes exemptions that apply to certain caregiving situations, such as when parents attempt to access confidential parts of an adolescent child’s records.

For information regarding exceptions to open notes, please see What Open Notes Exceptions Does the Cures Act Allow?

Seeing Open Notes as Part of High-Touch, High-Value Care

While many physicians and other providers have anticipated open notes with dread, most outcomes so far have been positive. Patients have reacted well to clarity. They have used open notes as a tool to improve their own understanding of and adherence to care instructions. When patients have noted valid issues or miscommunications, they have appreciated being able to quickly clear them up. More than an administrative burden, open notes present an opportunity to improve documentation, patientprovider relationships, and patient safety. By improving patient adherence to treatment plans, open notes have the potential to improve provider satisfaction, as well.

Chad Anguilm, MBA, is Vice President, In-Practice Technology Services, Medical Advantage, part of TDC Group. Richard F. Cahill, JD, is Vice President and Associate General Counsel, The Doctors Company, part of TDC Group. Kathleen Stillwell, MPA/HSA, RN, is Senior Patient Safety Risk Manager, The Doctors Company, part of TDC Group.

Controlled Substance Prescribing in Florida

NOVEMBER 9, 2021 | 2.0 AMA PRA Category 1 Credit(s)TM

SPEAKERS: Susan Griffee-Belcher, M.D. & Jeff Buchalter, M.D. Sanders Beach 913 South I Street 5:00 PM - 6:00 PM | Sign in and Buffett 6:00 PM - 8:00 PM | Presentation

Audience: All FL prescribing practitioners registered with the U.S. Drug Enforcement Agency and authorized to prescribe controlled substances.

space is limited, RSVP by 11/1

email: director@escambiacms.org or text 561-414-6113

LEARNING OBJECTIVES | Upon completion of this session, participants will be able to: ·Comply with the Florida Controlled Substances Bill (CS/CS/HB 21). ·Identify the requirements of the HB 21 including but not limited to: opioid abuse by establishing prescribing limits, requiring continuing education on controlled substance prescribing, expanding required use of Florida’s Prescription Drug Monitoring Program, and E-FORCSE. ·Review CDC guidelines for treating acute and chronic pain. ·Implement best practices in the administration of treatment plans in compliance with the controlled substance laws.

Hosted by: The Escambia/Santa Rosa County Medical Society & The Florida Academy of Family Physicians

This Community event is brought to you in part by:

Disclosure: The planners and speakers of this educational activity have no relevant financial relationships with ineligible companies to disclose

Accreditation Statement: The Florida Academy of Family Physicians is accredited by the Florida Medical Association to provide continuing medical education for physicians.

Designation Statement: The Florida Academy of Family Physicians designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credits™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.