In today’s rapidly evolving healthcare landscape, Nurse Practitioners (NPs) and Physician Assistants (PAs) play a pivotal role in addressing the growing demand for healthcare services.
These advanced practice providers have become indispensable members of healthcare teams, providing primary care, specialized services, and much-needed support. However, as their roles expand, so does the scrutiny of their professional liability.
This article delves into the critical issue of malpractice lawsuits involving NPs and PAs, shedding light on the causes, risks, and potential solutions. As NPs and PAs take on more responsibilities, it’s essential to understand the legal and practical challenges they face. We will explore the prevalence of such lawsuits, the reasons behind them, and ways to mitigate risks for these dedicated healthcare professionals.
- Nurse Practitioners (NPs) and Physician Assistants (PAs) play critical roles in addressing healthcare needs, but their expanding responsibilities bring increased scrutiny and potential malpractice risks.
- Understanding the legal framework for NPs and PAs, which varies by state, is essential to navigate the complexities of their practice and mitigate malpractice risks.
- Malpractice lawsuits involving NPs and PAs are on the rise, with common causes including misdiagnosis, medication errors, lack of informed consent, and inadequate supervision.
- Risks associated with malpractice claims impact NPs and PAs both personally and professionally, including emotional stress, damage to reputation, career uncertainty, and licensure challenges.
- Maintaining malpractice insurance is crucial for NPs and PAs to cover legal expenses and potential settlements.
- Strategies for mitigating malpractice risks include ongoing education and training, clear communication, collaboration, and continuous professional development.
- A supportive working environment, including team-based care and quality assurance programs, is vital for minimizing risks and ensuring patient safety.
- Advanced practice organizations can offer valuable resources and support for NPs and PAs, including advocacy, education, networking, and access to legal resources.
- Alternative solutions, such as telemedicine, expanding prescriptive authority, and interprofessional collaboration, can enhance the roles of NPs and PAs while reducing the risk of malpractice claims.
- Real-life case studies illustrate the positive impact of NPs and PAs in healthcare and the successful application of risk mitigation strategies.
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The Growing Role of NPs and PAs
Nurse Practitioners (NPs) and Physician Assistants (PAs) have been at the forefront of healthcare delivery for several decades.
These skilled professionals provide valuable services, including diagnosis, treatment, and education, often in underserved communities where access to medical care can be limited.
Their advanced training and ability to prescribe medications make them essential assets in bridging the healthcare provider gap.
As of 2021, NPs are licensed to practice in all 50 U.S. states, and the number of certified NPs has been steadily rising. According to the American Association of Nurse Practitioners (AANP), there were approximately 325,000 NPs in the United States in 2020, with 29,000 new NPs completing their academic programs that year.
Similarly, the number of certified PAs has been on the rise, with over 145,000 PAs practicing in 2020, according to the National Commission on Certification of Physician Assistants.
The Rising Concern: Malpractice Lawsuits
As NPs and PAs become more integral to the healthcare system, the potential for malpractice lawsuits involving them has increased. These lawsuits are not only a legal concern but also a matter of professional and personal consequence. In the following sections, we will explore the prevalence of malpractice lawsuits involving NPs and PAs, the common causes behind them, and the associated risks.
Let’s dive deeper into this complex issue to better understand the challenges that these dedicated healthcare providers face, and to discover potential solutions for mitigating the risks associated with malpractice claims.
Understanding the Role of NPs and PAs
To comprehend the complexities surrounding malpractice lawsuits involving Nurse Practitioners (NPs) and Physician Assistants (PAs), it’s vital to grasp their roles in the healthcare system. These dedicated professionals, often working alongside physicians, significantly contribute to patient care, and understanding their scope of practice is crucial.
Definition and Scope of Practice
Nurse Practitioners (NPs) are highly skilled registered nurses with advanced training and education, typically at the master’s or doctoral level. Their scope of practice encompasses a wide range of healthcare services, including:
- Diagnosis and Treatment: NPs can assess, diagnose, and treat various medical conditions. They can order and interpret diagnostic tests, prescribe medications, and develop treatment plans.
- Preventive Care: NPs emphasize preventive healthcare, such as immunizations, health education, and disease management, promoting healthier lifestyles among their patients.
- Patient Education: NPs play a crucial role in patient education, ensuring that patients understand their medical conditions, treatment options, and the importance of adherence to prescribed regimens.
- Specialized Care: Many NPs specialize in areas like pediatrics, gerontology, women’s health, and psychiatric care, further enhancing their contribution to healthcare.
Significance in Addressing the Healthcare Workforce Shortage
One of the primary reasons for the expanding role of NPs is the ongoing healthcare workforce shortage, especially in primary care. According to the Association of American Medical Colleges (AAMC), the United States is expected to face a shortage of between 21,100 and 55,200 primary care physicians by 2033 . NPs, with their broad training and ability to provide primary care, are instrumental in filling this gap, ensuring patients have access to the care they need.
Comparison to the Responsibilities and Training of Physicians
While NPs possess a wide range of skills and abilities, it’s essential to differentiate their roles from those of physicians. Physicians, including medical doctors (MDs) and doctors of osteopathic medicine (DOs), undergo extensive medical school training, residencies, and fellowships, which makes them experts in a particular field of medicine.
NPs, on the other hand, have a nursing background and advanced practice education that equips them to provide comprehensive care within their scope of practice. They often collaborate with physicians and other healthcare professionals, seeking guidance and consultation when necessary.
Understanding the distinctions between NPs, PAs, and physicians is crucial for establishing the context in which malpractice lawsuits involving NPs and PAs occur. These professionals’ roles are complementary, and their collaboration is vital for delivering high-quality healthcare services.
In the next section, we will explore the prevalence and causes of malpractice lawsuits involving NPs and PAs to gain insights into the challenges they face in their expanding roles.
Malpractice Lawsuits: Prevalence and Causes
As Nurse Practitioners (NPs) and Physician Assistants (PAs) take on more significant roles in healthcare, the frequency of malpractice lawsuits involving them has increased.
Understanding the prevalence and underlying causes of these legal actions is crucial in addressing the challenges they face in their expanding practice.
Statistical Overview of Malpractice Lawsuits
To appreciate the extent of malpractice lawsuits involving NPs and PAs, let’s examine some key statistics:
- Prevalence: Malpractice claims against NPs and PAs have been on the rise. The Nurse Practitioner Claim Report by Nurses Service Organization (NSO) in 2020 reported that 44% of NPs surveyed had faced a malpractice claim during their career, while 19% had experienced one within the previous five years.
- Costs: The financial implications of malpractice claims can be substantial. The same report highlighted that the average indemnity payment (the amount paid to resolve a claim) for NPs was approximately $220,000, with the highest payment reaching $2.9 million.
- Common Claims: The most frequent claims against NPs and PAs typically involve misdiagnosis, medication errors, failure to diagnose, and treatment complications.
Common Causes of Malpractice Claims
- Misdiagnosis and Delayed Diagnosis: Malpractice claims often arise from incorrect diagnoses or delays in diagnosing a medical condition. Given the complexity of healthcare, diagnostic errors can have severe consequences.
- Medication Errors: NPs and PAs can prescribe medications, and errors in dosage, administration, or prescribing the wrong medication can lead to malpractice claims. Medication-related claims are common in healthcare litigation.
- Lack of Informed Consent: Malpractice claims can result from the failure to obtain proper informed consent from patients. This includes not adequately explaining the risks and benefits of a treatment or procedure.
- Inadequate Supervision and Communication: In some cases, claims may involve allegations of inadequate supervision by a collaborating physician or ineffective communication within healthcare teams. Lack of clear documentation can also contribute to legal challenges.
High-Profile Cases and Their Implications
Several high-profile malpractice cases involving NPs and PAs have garnered public attention and raised concerns about patient safety. These cases often underscore the need for stringent oversight, quality assurance, and the importance of addressing the root causes of malpractice claims.
High-profile cases serve as a reminder of the critical importance of patient safety and the responsibility of healthcare professionals, including NPs and PAs, in providing high-quality care while minimizing the risk of malpractice claims.
Understanding the prevalence and causes of malpractice lawsuits involving NPs and PAs highlights the challenges these healthcare professionals navigate in their daily practice. It also underscores the importance of continually improving the quality of care provided by advanced practice providers.
Risks for NPs and PAs
As Nurse Practitioners (NPs) and Physician Assistants (PAs) assume broader responsibilities in healthcare, they inevitably face a spectrum of risks associated with malpractice claims. These risks encompass not only professional consequences but also personal and legal implications, making it imperative to understand the potential fallout of such claims.
Personal and Professional Consequences of Malpractice Claims
- Emotional Stress: Facing a malpractice claim is emotionally taxing for NPs and PAs. The mere existence of a lawsuit can lead to anxiety, stress, and even feelings of guilt, regardless of the claim’s validity.
- Professional Reputation: Malpractice claims can tarnish a healthcare provider’s professional reputation, affecting their ability to secure employment or establish their practice. In today’s digital age, reputation damage can be long-lasting.
- Career Uncertainty: The threat of a malpractice claim may lead to job insecurity or career setbacks. Employers may be reluctant to hire or retain healthcare providers who have faced such claims.
- Licensure Challenges: Depending on the outcome of the lawsuit, NPs and PAs may face disciplinary action from their licensing board, potentially resulting in suspension or revocation of their professional licenses.
Impact on Licensure, Career, and Reputation
- License Renewal: Many state licensing boards require healthcare providers to report any malpractice claims against them during the license renewal process. Failure to do so can result in further legal consequences.
- Malpractice Insurance: NPs and PAs often maintain malpractice insurance to cover legal expenses and potential settlements. The cost of insurance can rise substantially after a malpractice claim, adding financial pressure.
- Peer and Patient Trust: Trust is essential in healthcare. Malpractice claims can erode trust not only among peers but also with patients. This loss of trust can make it challenging to build effective working relationships and patient-provider rapport.
- Future Career Prospects: NPs and PAs who have been involved in malpractice claims may find it difficult to secure new employment opportunities or advance in their careers.
The Role of Malpractice Insurance for NPs and PAs
Malpractice insurance, also known as professional liability insurance, is a protective measure for NPs and PAs. It helps mitigate the financial risks associated with malpractice claims by covering legal defense costs and potential settlements.
The cost of malpractice insurance varies depending on factors like the provider’s specialty, location, and the number of past claims. Maintaining adequate malpractice insurance is a vital safeguard for NPs and PAs, helping to protect their financial well-being in the event of a malpractice claim.
Understanding the personal, professional, and legal implications of malpractice claims is essential for NPs and PAs. In the subsequent sections, we will explore the legal framework that governs their practice and strategies to mitigate the risks associated with malpractice lawsuits. These insights can help NPs and PAs navigate their roles more effectively and ensure the highest standard of care for their patients.
By comprehending the multifaceted risks that NPs and PAs face in the context of malpractice claims, we can better appreciate the importance of proactive risk management and the significance of maintaining the highest standards of care. In the next section, we will delve into the legal framework that regulates the practice of NPs and PAs and the standards they must uphold.
Legal Framework for Malpractice Claims
For Nurse Practitioners (NPs) and Physician Assistants (PAs), practicing within the bounds of the law and maintaining the highest standards of care is paramount. To understand the legal intricacies surrounding malpractice claims involving NPs and PAs, it’s essential to explore the legal framework governing their practice.
State-Specific Regulations and Requirements
- Licensure: The legal framework for NPs and PAs primarily operates at the state level. Each state has specific licensure requirements, and NPs and PAs must meet these to practice legally. These requirements often encompass education, certification, and continuing education.
- Collaborative Agreements: Many states require NPs to have collaborative agreements with physicians, outlining the scope of their practice, supervision, and protocols for consultation.
- Scope of Practice: The legal scope of practice for NPs and PAs can vary significantly from one state to another. State regulations dictate what procedures they can perform, their prescription authority, and the degree of autonomy they have in diagnosing and treating patients.
Collaborative Agreements and Supervisory Relationships
Collaborative agreements or supervisory relationships are integral components of the legal framework for NPs and PAs in many states:
- Collaborative Agreements: These formal agreements define the working relationship between NPs and supervising physicians, including details about patient care, consultation, and the extent of the NP’s authority.
- Supervisory Relationships: PAs are often required to practice under the supervision of a physician, with clear guidelines for when and how consultation or oversight should occur.
Standard of Care for NPs and PAs
NPs and PAs are held to the same standard of care as physicians. This means they are expected to provide care that meets or exceeds the accepted norms within their field of practice. Deviating from this standard can lead to malpractice claims if patient harm results from their actions or omissions.
Legal Standards for Informed Consent
Obtaining informed consent is a crucial aspect of healthcare, and failing to do so properly can lead to malpractice claims:
- Duty to Inform: NPs and PAs have a legal duty to provide patients with information about the risks, benefits, and alternatives of a recommended treatment or procedure. Failing to do so can result in claims of negligence.
- Patient Understanding: Informed consent should ensure that patients understand the information provided. If a patient feels they were not adequately informed, this could lead to a malpractice claim.
Understanding the legal framework within which NPs and PAs operate is essential for providing high-quality care while minimizing legal risks.
By delving into the legal framework that shapes the practice of NPs and PAs, we gain a deeper understanding of the regulations and requirements they must adhere to. This knowledge serves as the foundation for our exploration of strategies to minimize malpractice risks, which we will delve into in the next section.
Mitigating the Risks
The practice of Nurse Practitioners (NPs) and Physician Assistants (PAs) is not without its challenges and legal complexities. To minimize the risks associated with malpractice claims, these healthcare professionals can adopt a range of strategies. These strategies encompass education, communication, collaboration, and a commitment to continuous improvement.
Strategies for Minimizing Malpractice Risks for NPs and PAs
- Adequate Education and Training: Rigorous education and ongoing training are essential. NPs and PAs must stay up-to-date with the latest medical knowledge, guidelines, and best practices. Committing to lifelong learning enhances their competence and confidence.
- Clear Communication and Documentation: Effective communication with patients and within the healthcare team is paramount. Clearly conveying information, obtaining informed consent, and documenting care accurately can help prevent misunderstandings and legal challenges.
- Collaborative Practice Agreements: Complying with state-specific collaborative agreements or supervisory relationships ensures that NPs and PAs practice within the defined legal boundaries. Maintaining strong communication with collaborating physicians is essential.
- Continuous Professional Development: Staying current with the latest advances in healthcare, technology, and treatments is crucial. Professional development not only enhances patient care but also reduces the risk of malpractice claims.
The Importance of a Supportive Working Environment
- Team-Based Care: Collaborative, team-based care is a key factor in patient safety. NPs, PAs, and physicians working together seamlessly can minimize the risk of errors and improve patient outcomes.
- Quality Assurance Programs: Healthcare organizations should establish robust quality assurance programs to monitor, evaluate, and enhance the care provided by NPs and PAs. Regular reviews and feedback can lead to improvements and fewer legal challenges.
- Risk Management Training: NPs and PAs should receive training in risk management to understand the potential pitfalls and legal issues. Being proactive in addressing risks can prevent future malpractice claims.
The Role of Advanced Practice Organizations
Advanced practice organizations, such as the American Association of Nurse Practitioners (AANP) and the American Academy of Physician Assistants (AAPA), play a vital role in supporting NPs and PAs:
- Advocacy: These organizations advocate for the interests of NPs and PAs, helping shape legislation and regulations that govern their practice.
- Education: Advanced practice organizations offer educational resources, conferences, and guidance to ensure that NPs and PAs have access to the latest knowledge and best practices.
- Networking: Building a professional network within these organizations can provide valuable support, mentorship, and resources for NPs and PAs.
- Access to Legal Resources: These organizations often provide access to legal resources, including assistance in understanding and navigating the legal complexities of their profession.
Incorporating these risk-mitigation strategies can help NPs and PAs maintain the highest standard of care while minimizing the potential for malpractice claims. By ensuring that education, communication, collaboration, and continuous improvement are at the forefront of their practice, these healthcare professionals can contribute to safer, more effective healthcare delivery.
As NPs and PAs continue to expand their roles in healthcare, the strategies outlined in this section are essential for promoting patient safety and minimizing legal risks. The subsequent section will delve into alternative solutions, including technological advancements and changes in prescriptive authority, that can further enhance their contributions to healthcare.
While understanding the risks and adopting risk-mitigation strategies is crucial for Nurse Practitioners (NPs) and Physician Assistants (PAs), exploring alternative solutions can further enhance their roles in healthcare, reduce the likelihood of malpractice claims, and address the challenges they face.
Telemedicine and Remote Supervision
- Telemedicine: Embracing telemedicine can expand the reach of NPs and PAs to underserved areas while allowing for remote consultations with patients and physicians. This not only increases access to care but also facilitates timely supervision and collaboration, reducing the risk of medical errors.
- Remote Supervision: Technology enables effective remote supervision of NPs and PAs by physicians. With real-time video conferencing and secure communication platforms, physicians can provide guidance and oversight even when not physically present, ensuring that patient care meets the highest standards.
Expanding Prescriptive Authority for NPs and PAs
- Prescription Rights: Expanding the prescriptive authority of NPs and PAs can increase patient access to essential medications. NPs and PAs can be granted the ability to prescribe a broader range of medications, reducing the need for physician intervention in routine cases.
- Collaborative Decision-Making: Collaboration between NPs, PAs, and physicians in prescribing medications can foster a team-based approach to care. This allows for a collective assessment of the best treatment options, optimizing patient safety.
Team-Based Care and Interprofessional Collaboration
- Team-Based Care: Implementing interprofessional care models where NPs, PAs, and physicians work closely alongside other healthcare professionals, such as nurses, pharmacists, and social workers, can lead to comprehensive, coordinated, and patient-centered care.
- Information Sharing: Efficient and secure electronic health records and communication systems facilitate the exchange of patient information among team members, reducing the risk of miscommunication or errors.
- Mentorship and Education: NPs and PAs can benefit from mentorship and collaboration with more experienced colleagues, including physicians. This approach not only enhances their skills but also ensures a culture of continuous learning and improvement.
Exploring these alternative solutions can help NPs and PAs maximize their contributions to healthcare while mitigating the risks associated with malpractice claims. By leveraging technology, expanding their roles, and embracing team-based care, NPs and PAs can play a vital role in addressing the ongoing challenges in healthcare.
As NPs and PAs continue to adapt to the changing healthcare landscape, these alternative solutions can enhance their effectiveness and improve patient outcomes while minimizing the risk of malpractice claims. The subsequent section will provide real-life case studies to illustrate the successful implementation of risk-mitigation strategies.
To illustrate the practical application of risk mitigation strategies and the valuable contributions of Nurse Practitioners (NPs) and Physician Assistants (PAs) in healthcare, we present real-life case studies. These examples showcase successful outcomes and the positive impact NPs and PAs can have on patient care.
Case Study 1: Telemedicine in Rural Healthcare
Background: In a remote, underserved area with limited access to healthcare, a collaborative healthcare team implemented a telemedicine program that included an NP and a supervising physician.
The Strategy: The NP, trained in telemedicine protocols, conducted virtual visits with patients who needed medical care. The supervising physician provided remote oversight and consultation when necessary.
- Improved Access: Telemedicine allowed patients to receive timely care without traveling long distances.
- Patient Satisfaction: Patients reported high levels of satisfaction with the telemedicine program.
- Reduced Errors: Remote supervision and collaborative decision-making reduced the risk of medical errors.
Case Study 2: Expanding Prescriptive Authority
Background: In a primary care clinic facing a shortage of physicians, NPs and PAs were granted expanded prescriptive authority to manage common chronic conditions independently.
The Strategy: NPs and PAs were trained in updated guidelines and evidence-based practices for managing chronic conditions, including diabetes and hypertension. They had the authority to prescribe and adjust medications within defined parameters.
- Enhanced Access: Patients with chronic conditions received care promptly, improving disease management.
- Reduced Physician Burden: Physicians were able to focus on more complex cases, increasing the efficiency of the healthcare team.
Positive Patient Outcomes: The expanded prescriptive authority contributed to better patient outcomes and reduced hospital admissions.
Case Study 3: Interprofessional Collaboration in a Geriatric Care Team
Background: A geriatric care team in a long-term care facility integrated NPs, PAs, nurses, and pharmacists to provide comprehensive care for elderly residents.
The Strategy: Interprofessional collaboration meetings were held regularly to discuss resident care plans, medication management, and holistic assessments. NPs and PAs played key roles in coordinating care.
- Comprehensive Care: The holistic approach improved residents’ overall well-being.
- Medication Safety: Collaboration with pharmacists reduced medication errors and adverse drug interactions.
- Enhanced Staff Satisfaction: The team-based approach fostered a positive work environment and led to better staff retention.
These case studies underscore the potential of NPs and PAs to improve patient care and mitigate risks through innovative strategies, teamwork, and collaboration. The success stories illustrate the valuable contributions NPs and PAs can make to the healthcare system and patient outcomes.
As NPs and PAs continue to adapt to their evolving roles, these real-world examples demonstrate the positive impact they can have on patient care and safety while minimizing the risks associated with malpractice claims. These case studies exemplify the dedication and innovation of NPs and PAs in delivering high-quality healthcare services.
Nurse Practitioners and Physician’s Assistants Malpractice Case Examples
Researchers searched the Thomson Reuters Westlaw database for jury verdicts and settlements from 1985 to 2020 that contained the words “malpractice” and either “physician assistant” or “nurse practitioner.”
Cases Involving Nurse Practitioners and Physician Assistants
- This publication contains an analysis of aggregated data from clinically coded cases opened between 2012-2021 in which a nurse practitioner (NP) or a physician assistant (PA) was involved.
- The report found that the most common allegations against NPs and PAs were related to diagnosis, treatment, and medication errors.
- The median indemnity payment for cases involving NPs and PAs was $250,000 DNP Sued for Referring to Herself as Doctor
- A nurse practitioner with a doctorate of nursing practice was sued for fraud after referring to herself as “Dr. Sarah” on her website and social media.
- The complaint charged that she “unfairly elevated her position among other registered nurse practitioners.”
- The case was referred to the District Attorney, who charged her with fraud.
- She settled the case by paying an almost $20,000 fine.
- During 2005 through 2014, there ranged from 11.2 to 19.0 malpractice payment reports per 1,000 physicians, 1.4 to 2.4 per 1,000 PAs, and 1.1 to 1.4 per 1,000 NPs.
- Diagnosis-related malpractice allegations varied by provider type, with physicians having significantly fewer reports (31.9%) than PAs (52.8%) or NPs (40.6%) over the observation period.
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The expanding roles of Nurse Practitioners (NPs) and Physician Assistants (PAs) in healthcare bring with them both opportunities and challenges.
In this comprehensive exploration of malpractice lawsuits involving NPs and PAs, we have examined the prevalence, causes, risks, legal framework, risk mitigation strategies, and alternative solutions to address the issues they face.
The case studies provided real-world examples of how these professionals contribute to improving patient care and safety.
NPs and PAs are crucial components of the healthcare workforce, helping to address access to care in underserved areas and support the delivery of high-quality healthcare. However, as their responsibilities grow, it is essential to be aware of the potential risks they face, including malpractice claims.
By understanding these risks and adopting proactive risk mitigation strategies, NPs and PAs can provide care that meets the highest standards and contribute to the betterment of the healthcare system.
The legal framework that governs the practice of NPs and PAs is complex and varies from state to state. It’s imperative for these healthcare professionals to adhere to state-specific regulations and requirements, maintain collaborative relationships, and uphold the standard of care.
Additionally, clear communication, continuous education, and a commitment to teamwork and interprofessional collaboration are essential for providing patient-centered care while minimizing legal risks. Telemedicine, expanded prescriptive authority, and the use of technology offer innovative solutions to enhance the effectiveness of NPs and PAs.
The case studies provided real-world evidence of the positive impact of NPs and PAs on patient care. They highlighted the importance of these healthcare professionals in improving access to care, enhancing patient satisfaction, and reducing medical errors.
NPs and PAs play a vital role in addressing the healthcare challenges of our time. By understanding the risks, adhering to legal requirements, and adopting innovative strategies, they can continue to be invaluable assets in delivering high-quality, safe, and accessible healthcare to patients across the nation.
What is the most common reason nurse practitioners are sued?
The most common reasons NPs are sued include misdiagnosis, medication errors, delayed diagnosis, and lack of informed consent.
What are the most frequent malpractice allegations against Aprns?
The most frequent malpractice allegations against Advanced Practice Registered Nurses (APRNs), which includes NPs, often revolve around issues such as misdiagnosis, medication errors, and complications arising from treatment.
Are PAs more respected than NPs?
The level of respect for PAs and NPs varies depending on the context and individual perspectives. Both professions play vital roles in healthcare, and respect may differ by region, healthcare setting, and the perception of healthcare professionals and patients.
Is a collaborating physician liable for a nurse practitioner’s error?
The liability of a collaborating physician for an NP’s error depends on various factors, including state-specific regulations and the nature of the error. In some cases, the collaborating physician may share liability, while in others, the NP may bear primary responsibility, as the legal framework differs by state.