How Might Antibiotic Stewardship Programs Influence Clinicians' Autonomy and Organizations' Liability?

Federal and state governments mandate some health care organizations to implement antibiotic stewardship programs (ASPs). Some early adopters developed model ASPs that have helped set industry standards; other benchmarks will likely be forged in subsequent regulation, legislation, and jurisprudence. This article considers how ASP designs can affect professional autonomy, especially of frontline antibiotic stewards who are usually physicians and pharmacists. This article also considers how ASP development and implementation might influence standards of care and malpractice liability.

Malpractice litigation surrounding in vitro fertilization in the United States: a legal literature review.

IMPORTANCE: Analysis of malpractice lawsuits that involve in vitro fertilization (IVF) can provide insight into the breadth of legal challenges faced by IVF clinics and the patient harms and financial consequences that can result from alleged errors in practice. OBJECTIVE: We aimed to review malpractice litigations involving IVF and identify common themes in plaintiff allegations and defense arguments. EVIDENCE REVIEW: We queried Nexis Uni, Westlaw, and CourtListener legal databases to collect records from malpractice litigations involving IVF. The nature of the cases, allegations, and outcomes were abstracted from court documents. FINDINGS: Of the 447 cases identified in the query, 53 involved both malpractice and IVF, occurring between 1993 and 2022. Defendants included a reproductive endocrinologist in 19 (35.8%) cases, an academic institution in 17 (32.1%) cases, embryology personnel in 9 (17.0%) cases, and nursing staff in 2 (3.8%) cases. Twenty-four (45.3%) cases involved embryology errors (e.g., lost specimens and incorrect sperm donor), 11 (20.8%) preimplantation genetic testing errors (e.g., child born with genetic illness despite testing), 6 (11.3%) medical or surgical complications (e.g., ovarian hyperstimulation syndrome), 4 (7.5%) misdiagnoses (e.g., malignancy before cycle start), 3 (5.6%) misrepresentations of IVF outcomes, 2 (3.8%) medical eligibility screening issues (e.g., medical comorbidities in a gestational carrier), 2 (3.8%) confidentiality breaches, and 1 (1.9%) case of discrimination. The most common secondary claims were negligence (23 cases, 16.4% of all claims), breach of contract (13, 9.3%), lack of informed consent (11, 7.9%), and negligent infliction of emotional distress (11, 7.9%). Twenty-nine (54.7%) cases were decided in favor of the defending IVF clinic or provider, 13 (24.5%) cases were decided in favor of the plaintiff, and 11 (20.8%) involved ongoing proceedings. Financial awards ranged from $4171 to $14,975,000, with the largest monetary award resulting from a cryostorage accident class action lawsuit. CONCLUSION: In vitro fertilization malpractice claims are varied, with the most common issues involving embryology laboratory processes and genetic testing errors. Some errors may be avoidable with increased vigilance and implementation of stringent laboratory and clinical guidelines. Understanding jurisdiction-specific legislation and court processes may also assist IVF providers in navigating the malpractice litigation process. RELEVANCE: This comprehensive review of IVF litigation may have the potential to promote practices that protect both providers and patients.

Legal implications of antibiotic stewardship programs.

Infectious diseases professional societies, public health agencies, and healthcare regulatory agencies call for antibiotic stewardship programs (ASP) in many healthcare settings. However, medical legal implications of these programs remain largely uncharted territory. Although there is no legal precedent addressing issues of liability and standards of care on this subject, anticipating how the courts may assess questions of medical liability with respect to the various components of ASPs is important to define best practices in ASP operations, not only to manage the potential risk but also to improve patient care. This article seeks to address some of the common processes and interventions involved in antibiotic stewardship and the potential professional liability implications of these activities.

Physician Engagement in Malpractice Risk Reduction: A UPHS Case Study.

BACKGROUND: The University of Pennsylvania Health System (UPHS) implemented a risk reduction strategy in response to high malpractice costs and the broader implications these trends had for patient safety and quality. A key component of this strategy was the Risk Reduction Initiative (RRI), which uses a bottom-up approach to actively engage physicians in risk mitigation and malpractice reduction within their respective departments. METHODS: The value of clinical communities in achieving common goals has been previously recognized in quality improvement efforts. Using a physician-directed approach, the RRI program requires each clinical department to propose and execute an intervention in response to prior malpractice claims data or recognition of an area of high risk. Based on the success of the intervention, clinical departments were eligible to receive a financial rebate for use in future quality improvement projects. RESULTS: Clinical departments have led the development and implementation of interventions that have shown demonstrable improvements in quality and safety and thereby received full financial rebates. On a system level, the inclusion of physicians in risk mitigation efforts has resulted in significant benefits from both quality improvement and financial standpoints. The number of malpractice claims and malpractice cost have decreased since the inception of the program. CONCLUSION: Since the program inception, 250 proposals have been submitted and $14 million in rebates have been awarded. Although it is difficult to directly measure the combined impact of these bottom-up, physician-directed interventions, empowering frontline physicians to become actively involved in risk mitigation is a promising method for reducing malpractice claims and costs.

Taking the Initiative: Risk-Reduction Strategies and Decreased Malpractice Costs.

BACKGROUND: To heighten awareness of attending and resident surgeons regarding strategies for defense against malpractice claims, a series of risk reduction initiatives have been carried out in our Department of Surgery. We hypothesized that emphasis on certain aspects of risk might be associated with decreased malpractice costs. The relative impact of Department of Surgery initiatives was assessed when compared with malpractice experience for the rest of the Clinical Practices of the University of Pennsylvania (CPUP). STUDY DESIGN: Surgery and CPUP malpractice claims, indemnity, and expenses were obtained from the Office of General Counsel. Malpractice premium data were obtained from CPUP finance. The Department of Surgery was assessed in comparison with all other CPUP departments. Cost data (yearly indemnity and expenses), and malpractice premiums (total and per physician) were expressed as a percentage of the 5-year mean value preceding implementation of the initiative program. RESULTS: Surgery implemented 38 risk reduction initiatives. Faculty participated in 27 initiatives; house staff participated in 10 initiatives; and advanced practitioners in 1 initiative. Department of Surgery claims were significantly less than CPUP (74.07% vs 81.07%; p < 0.05). The mean yearly indemnity paid by the Department of Surgery was significantly less than that of the other CPUP departments (84.08% vs 122.14%; p < 0.05). Department of Surgery-paid expenses were also significantly less (83.17% vs 104.96%; p < 0.05), and surgical malpractice premiums declined from baseline, but remained significantly higher than CPUP premiums. CONCLUSIONS: The data suggest that educating surgeons on malpractice and risk reduction may play a role in decreasing malpractice costs. Additional extrinsic factors may also affect cost data. Emphasis on risk reduction appears to be cumulative and should be part of an ongoing program.

The basics of medical malpractice: a primer on navigating the system.

Medical malpractice with its associated costs, including insurance premiums, impact on practice, consequences for career and insurability, and emotional toll, is a reality of practicing medicine in the United States. Understanding the types of claims that may be asserted, the issues to consider when securing insurance coverage, how to manage the cost of insurance, the nuances of the claims process, and the implications of the claims process are critical to the successful management of this aspect of medical practice. This article provides a guide for practicing physicians on the legal, financial, and practical considerations involved.