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Signed Consent: Does it Prevent Litigation?

Many healthcare professionals believe that a signed document equals informed consent, and that no further documentation is necessary. While that theory is basically true, there is definitely a difference between theory and practice. The obligation (in both the ethical and legal sense) to fully inform patients of the risks, benefits, and alternatives to treatment falls to the treating provider. Informed consent is best described as a process, not a single document. Patients must demonstrate their understanding of the treatment being pursued, as well as an explanation of both the provider’s and the patient’s roles in the treatment, as well as the risk of addiction to the medications prescribed.

Consider our recent case study(1) involving a patient who allegedly died of a prescription overdose because the plaintiff contends that the multiple providers he sought treatment from were negligent in monitoring his conditions and medications. Reading through the documentation, it seems that no single provider was aware of the patient’s entire medical history, nor his current medication intake. And while the patient provided informed consent about the possibility of drug interactions to multiple providers, the seriousness of the situation did not appear evident to all involved parties, including the providers and the patient.

CARE Professional Liability Association and OmniSure Consulting Group(2) suggest the following steps to reduce your professional risk(3):

  • Customize consent forms to be as procedure-specific as possible; generic forms are too generalized to communicate proper information
  • Document the entire consent process in the patient’s medical record, including the conversation with the patient and specific questions they asked and how they were answered
  • Create policies and procedures outlining who specifically can obtain informed consent
  • Audit medical records periodically to validate that documentation and informed consent processes are being followed correctly

Patients might be too embarrassed to ask questions about the procedure, or might not even know what to ask if they don’t understand the consent form. Or they might feel rushed, or simply downplay the consent form’s importance. It’s our job as healthcare providers to make sure patients are comfortable enough to ask pertinent questions so that their consent is not simply a signature, but a complete understanding of the treatment they receive.

Contact us today. We can help you develop an informed consent documentation plan that works for both you and your patients.

Footnotes

  • https://care-ins.com/case-studies/
  • https://www.omnisure.com/
  • https://www.riskfitness.com/informed-consent-recommendations

CARE Joins Forces with Digital Surgery

At CARE, we strive to partner with other industry leaders who can bring high-quality, meaningful contributions to our members. In the spirit of that goal, we have joined forces with Digital Surgery, a leader in simulation training, surgical video management and storage, and automated surgical analytics. Digital Surgery’s award-winning mobile application Touch Surgery houses more than 200 surgical simulations across 14 specialties, and its content library is continuously growing. The company’s latest offering, Touch Surgery Professional, offers secure video storage and management, automated analytics, annotation tools, and sharing capabilities for peer review and training purposes.

Together, CARE and Digital Surgery offer unique benefits to members that make coverage through CARE an even more invaluable investment. For example, qualified* Touch Surgery Professional (TS Pro) members can receive up to 10% off their CARE insurance policy. Another benefit of combined membership is knowledge exchange, which grows exponentially as members exchange ideas, solutions, and best practices via the TS Pro platform.

Digital Surgery’s goal is to utilize digital technology to empower surgeons and surgical teams all over the world to create safer, better outcomes. Like many of us in the healthcare field, Digital Surgery wants its tools to help increase knowledge and improve the delivery of surgical care across the globe. 

Contact us today. We can help you maximize your membership through our collaboration with Digital Surgery. Working together, we bring these industry-leading tools and resources to you to optimize your and your team’s training, shared learning, and performance in the operating room. 

*Qualified Digital Surgery members are those who have signed up for the Touch Surgery Professional offering, available for $999 for an annual subscription. This subscription provides access to (1) all of Digital Surgery’s publicly available CG and video-based simulations, (2) Digital Surgery’s video upload and storage platform, with automated analytics for selected procedures, (3) tools to annotate videos; add instruments, notes, and assessments; and to share with colleagues or trainees for peer review or training purposes. A minimum of 50 surgical videos are required to be uploaded annually to the Touch Surgery Professional video platform in order to remain eligible for the CARE insurance premium discount.

Seven Elements You Need to Understand in Medical Malpractice Policies

Providers have plenty of options when purchasing medical malpractice coverage. Both the availability of coverage options and the types of plans available can seem a bit overwhelming. Standard insurance companies, as well as specialty insurers, provide policies. But don’t overlook risk retention groups, which can provide great rates along with additional concierge-level services and benefits.

When reviewing a policy, pay attention to the following elements:

  1. Specific coverage details: For example, determine whether the policy covers compliance-related incidents or HIPAA violations.
  2. Conditions, exclusions: most policies do not cover criminal acts or sexual misconduct.
  3. Financial limitations: malpractice policies usually have one cap for the maximum paid per claim per policy year, and another cap that is the maximum paid for all claims during the policy year.
  4. Policy definitions: what is the “general standard of patient care”, and who defines it?
  5. Subcontractor liability: determine whether you are a subcontractor to the hospital or clinic where you perform services. Ask if your office/lab personnel are considered your subcontractors.
  6. Litigation-related costs: this includes what it costs to defend your firm in court, attorney fees, court costs, arbitration and settlement costs, medical damages, and punitive and compensatory damages.
  7. Reporting period (claims made vs. claims occurrence): in short, a claims-made policy provides coverage if the policy is in effect both when the incident took place and when the lawsuit is filed.

Additionally, it’s important to know your state’s malpractice insurance minimum requirements (if applicable) before purchasing a policy. Not only are state-mandated minimums important, but also consider your own personal and practice asset protection needs, which may vary greatly based on your risk-aversion mentality. It might be in your best interest to work with a professional consultant to determine the appropriate type and amount of coverage for your particular situation.

Contact us today. We can help determine your risk threshold, as well as help you feel comfortable in making a sound decision about medical malpractice insurance.  

Swiss Cheese and Malpractice Litigation

What do Swiss cheese and malpractice litigation have in common? Neither exist without the holes in them. In a clinical care setting, as depicted by the image to the right, the probability for error increases as your gaps in care increase. The more ‘holes’ you have, the better chances of those holes aligning, making way for adverse events that could result in a malpractice suit.

Areas of particular concern (1) include:

  • Consent
  • Supervision
  • Patient history and physical
  • Documentation
  • Provider collaboration
  • Pain management
  • Staff training
  • Communication

We’ll explore each of these clinical elements in more depth in future blogs.

Generally speaking, errors and adverse events are often a combination of human, electronic, and technical errors. The goal shouldn’t be to assign blame, but rather to mitigate the issues (2) so that they don’t happen in the first place, or in the very least, so that they don’t recur. Usually, this is best accomplished by recognizing and addressing systems issues. What systemic changes can be made to better support the clinician at the point of care and to prevent similar mistakes or adverse outcomes? No one truly benefits from a malpractice suit, not even the plaintiff if they win. They incurred some sort of loss to become a plaintiff in the first place, and would surely rather choose not to, if they could do it all over again.

Not all adverse events result in death, disability, or other major/chronic issues. However, the goal of risk mitigation is to reduce the overall trend of adverse events in total. Even issues deemed to be minor or insignificant (3).

The Swiss cheese model (4) is not germane to the healthcare industry. It can be applied to any industry where singular issues, when compounded with other seemingly singular issues, create a sum (adverse event) greater than their parts. Picture it as slicing a block of Swiss cheese, and laying the slices atop each other. It’s practically inevitable – something will eventually slip through every slice.

Be assured that the partnership between CARE and OmniSure provides you with a plethora of knowledge, experience, and expertise to help your practice identify potential holes, if you will, in your risk management plan. Contact us today for more information.

References

  • https://omnisure.wistia.com/medias/51g19jcybx
  • https://mckinneylaw.iu.edu/ihlr/pdf/vol16p21.pdf
  • http://files.constantcontact.com/68ac21ab401/4cb9c5c5-ba86-4ba8-ae9c-041f1b78f673.pdf
  • https://www.youtube.com/watch?v=JRCMxfBULB4

Adverse Anesthesia Events: Are They Inevitable?

Statistically speaking, anesthesia-related deaths are very rare: only one death is reported per every 200,000 – 300,000 events. But as with any medical procedure, there is room for improvement, including more stringent monitoring techniques and widespread adoption of best practices. Both of these suggestions can pave the way for standardized procedures to make that statistic even smaller.

The leading causes of anesthesia-related issues include:

While not all adverse events result in death, serious issues can arise, such as brain injury, brain death, increased cardiac and respiratory complications, prolonged hospital stays, and necessary mechanical ventilator support.

Patient knowledge, consent, and comfort are important factors in anesthesia care. Thoroughly discussing techniques, risks, and outcomes with patients encourages candid dialogue about patient history, current physical constraints, or even mental illness that may affect certain modes of anesthesia. Setting the proper expectations for patients creates an environment of trust and confidence in their providers.

In the unlikely event that issues arise, immediately document every aspect of the incident. While this includes a thorough description of technical events, don’t overlook the importance of engaging relevant consultants, such as neurologists and radiologists. Professionals from other disciplines can provide valuable third-party insight in determining cause and effect.

CARE members also have valuable resources at their disposal, such as the RiskFit helpline (available compliments of CARE’s partnership with OmniSure). This helpline can answer questions and provide guidance on how to best mitigate the risk arising from adverse events. The RiskFit helpline garners best practices from the volume of information it collects on similar events. Coupled with the experience level of the associates that provide consultations, this information helps members decide on the best course of action specific to their situation.

Contact us today if you would like more information about the benefits of joining CARE, or would like to see how the CARE/OmniSure partnership can benefit you too.

The Case for Case Studies

As a medical provider, you know the inherent risk and likelihood of unforeseen adverse events. You may need advice when these situations unfold. CARE, through our partnership with OmniSure, offers a helpline specifically for such issues. The helpline assists with questions about specific incidents, risk mitigation, and regulatory-related issues.

We then use the information gathered from our helpline to develop case studies, which in turn help our clients navigate the waters of incident reporting and risk mitigation. The aggregation of this data, coupled with our extensive experience, provides clients with examples, solutions, and best practices of clients that have been in similar situations.  

In this and future posts, we will explore case studies, and how learning from them helps our clients prevent future claims. As an example, this case study outlines a lawsuit wherein the plaintiff alleges that her husband died as a result of a prescription overdose after seeking care from multiple providers – including independent physicians, supervised nurse practitioners, independent advanced practice providers, and specialty clinics – who were negligent in the treatment and monitoring of the patient and his condition. While this case has not been settled yet, it does remind providers of the importance of completing a thorough patient history, as well as patient follow up.

We all make mistakes, in both our personal and professional capacities. To err is human. If you have patient safety or risk management questions, or need guidance after a potentially litigious event, get the guidance of a clinical risk specialist. Don’t go it alone. As a CARE policyholder, you have access to confidential advice-on-demand from a third-party firm that specializes in helping avoid litigation by protecting your patients, your license, and your reputation. Click here for more information.  

The Benefits of a Solid Risk Management Plan

It’s imperative to be proactive in healthcare. Not only in caring for your patients and staff, but also to stay ahead of any inherent risks to your business. A solid risk management plan reduces your liability in the first place, and acts to minimize litigation (should it happen). This protects not only your financial standing and assets, but also your firm’s market share, accreditation, reimbursement levels, brand value, and community standing.

One major benefit of instituting a risk management plan is that it improves patient outcomes too. A heightened awareness of processes, especially documentation, instills a sense of professionalism across your entire team, including both healthcare workers and office staff. This in turn reduces errors, which improves patient satisfaction and strengthens your reputation in the community. It also increases your bottom line by reducing expenses.

Risk management, at a basic level, is the responsibility of everyone employed at your business. But since everyone already has a full plate of responsibilities, their role is usually more reactive (to specific events) than proactive (looking at the big picture). You also need an expert on your team. Depending on the size of your practice, it might make sense to hire a risk manager. However, more often than not, your budget simply doesn’t have the room to take on a full-time salaried position. Partnering with a third-party risk management firm might be the perfect compromise.

Speaking of third parties, a level of risk is both assumed and mitigated whenever you contract with third parties. Not just for malpractice management, but for any services. Consider basics, such as records management and document shredding services. These may seem like simple tasks, but everything related to healthcare records needs to be considered under the watchful umbrella of compliance. Data sharing, storage, and destruction all fall under that umbrella.

Contact us today if you have questions about risk management and outsourcing those types of responsibilities. We would love to put our collective experience to work for you.

CARE and OmniSure: A Solid Partnership

CARE Professional Liability Association has partnered with OmniSure Consulting Group, a risk management and loss-control firm, to provide you with complimentary access to Risk Fitness®, which is an online tool that helps reduce your professional risk. This includes the RiskFit® library, email tips, and the RiskFit® helpline.

As the program name implies, it’s designed to ensure your firm’s well-being. The experts that manage the helpline could be considered your trainers. The health of your risk management plan is dependent on more than a single site visit for a cursory assessment. It is not a static event. A healthy risk management plan requires curating over time, introducing best practices as they are learned and new policies as they are developed.

The RiskFit helpline can help you with questions about your professional practice, risk mitigation, and regulatory-related issues. In addition to calling, you can also send an email to helpline@omnisure.com. You might know your business best and have great relationships with your patients, but you shouldn’t be expected to know every nuance of every change in laws and regulations. You need a resource you can depend on. That’s what the RiskFit helpline is to you … a lifeline.

Every company has its own risk management challenges. It’s important to partner with an organization that can provide insight about gaps, concerns, and challenges from an outside party’s perspective. Many claims and lawsuits can be traced to poor risk management and inattention to detail. In the daily barrage of work, these elements are easy to overlook. Some areas that usually end up lacking are documentation, follow up, and patient communication. It’s easy to become complacent.  

Contact us today. We can help you maximize your RiskFitness tools through our partnership with OmniSure. The collective knowledge and experience we all bring to the proverbial table makes us better-informed resources for each other.