FDA's proposed rule for the regulation of laboratory-developed tests.

In October 2023, the Food and Drug Administration (FDA) released a proposed rule that ends enforcement discretion for laboratory-developed tests (LDTs). The FDA's proposal outlines a five-stage implementation to begin regulating LDTs as they do for commercial in vitro diagnostics (IVDs), including modified FDA-approved/cleared tests. We outline here concerns from the clinical and public health microbiology laboratory perspective. It is our opinion that LDTs performed by individual Clinical Laboratory Improvement Amendments-certified diagnostic laboratories should not be regulated in the same way as commercial IVDs. This rule, if finalized, will negatively impact the diagnostic services currently offered by clinical and public health laboratories and, therefore, patients and the providers who care for them. Ending enforcement discretion will likely stifle diagnostic innovation and decrease access to diagnostic testing and health equity. Furthermore, the lack of infrastructure, including personnel and funding, at the FDA and diagnostic laboratories to support the required submissions for review is an obstacle. Like the FDA, diagnostic laboratories prioritize patient safety, accurate clinical diagnostics, and health equity. Since the scope of the LDT landscape is currently unknown, we are supportive of a registration process, along with non-burdensome adverse event reporting, to first understand the scope of clinical use of LDTs and any associated safety concerns. Any regulatory rule should be based on data that have been gathered systematically, not anecdotes or case reports. A rule must also balance the potential negative impact to patient care with realistic safety risks for infectious disease diagnostics.

"We need to confirm at least from two or three": Healthcare workers' discretion as gatekeepers in the context of the Ethiopian abortion law.

INTRODUCTION: Women's access to legal and safe abortion is a vital means to reduce unsafe abortion, which in turn is known to reduce maternal morbidity and mortality. In 2005, Ethiopia enacted a relatively permissive abortion legislation. However, there is evidence that access to abortion care services may be challenging and controversial even if progressive abortion laws are in place. This article examines women's access to abortion services from the perspective of healthcare workers in a rural setting in Ethiopia. Drawing on Lipsky's theory of street-level bureaucrats, the article discusses healthcare workers' discretion and the substantial authority they hold as gatekeepers to safe abortion services. METHODS: The study draws upon a qualitative, interpretative methodological approach, with in-depth semi-structured interviews with healthcare workers as the key method of data generation. The data was analyzed and interpreted thematically. Healthcare workers' perspectives were examined with reference to the national abortion legislation and guidelines. RESULTS: The findings reveal that healthcare workers make decisions on behalf of the women who seek abortion, and they involve parents and partners in abortion-related decision-making processes. Moreover, they assess the social context of the pregnancy such as the marital and economic statuses of the abortion-seeking women in ways that restrict women's access to legally-endorsed abortion services. CONCLUSIONS: Healthcare workers' practices in this rural area were found to challenge the basic provisions laid out in Ethiopia's abortion legislation. Their negative discretion of the legislation contributes to the substantial barriers Ethiopian abortion-seeking women face in gaining access to legal abortion services, despite the presence of a progressive legal framework and guidelines.

Nurses' professional discretion in the purchaser-provider split in home care in Norway.

AIM: To explore how nurses' professional discretion is operationalized in home care services that follow a purchaser-provider organization in Norway. DESIGN: A qualitative descriptive study. METHODS: Semi-structured interviews with open-ended questions were used, and data were collected from in-depth interviews with 15 registered nurses working in home care in four Norwegian local authority areas between April and November 2020. Braun and Clark's six-step analysis was used to analyse the empirical data. RESULTS: The analysis yielded two main themes, namely 'The purchaser's instructions: facilitating and constraining care' and 'Professional discretion meets the purchaser-provider organisation of healthcare,' with five associated codes. CONCLUSION: Nurses are dependent on an organizational framework due to the complexity of health care services and the number of tasks involved. At the same time, they perform considerable compensatory work and need the ability to be flexible to enable this work and to perform actions related to the unforeseen needs of individual patients or those involving professional discretion. IMPACT: The purchaser-provider model both facilitates and constrains nursing practice and professional responsibility in home nursing. Home nursing services need to be well organized because of their complexity and the wide variety of tasks they involve. In this context, the element of constraint is associated with the need for flexibility and professional discretion. Despite a strict framework, the nurses perform additional and compensatory tasks. Reforms inspired by 'New Public Management,' such as the purchaser-provider split, limit the workload for nurses; however, there is still a need to exercise discretion. The findings of this study may help home care managers and health policy-makers understand the interaction between management logic and health care logic, leading to a more appropriate organization of health care services where the nurses, as actors, gain more trust. IMPLICATIONS: This study highlights home care nurses' opportunities to exercise discretion in an organizational framework that strives towards standardization. The nurses' ability to exercise discretion is important for individual and holistic patient care. At the same time, an organizational framework is needed because nurses cannot attend to all the needs the patients may have, as this will overload both home health services and the nurses.

Pandemic ethics and beyond: Creating space for virtues in the social professions.

BACKGROUND: During the pandemic, social and health care professionals operated in 'crisis conditions'. Some existing rules/protocols were not operational, many services were closed/curtailed, and new 'blanket' rules often seemed inappropriate or unfair. These experiences provide fertile ground for exploring the role of virtues in professional life and considering lessons for professional ethics in the future. RESEARCH DESIGN AND AIM: This article draws on an international qualitative survey conducted online in May 2020, which aimed to explore the ethical challenges experienced by social workers during Covid-19. PARTICIPANTS AND RESEARCH CONTEXT: 607 social workers responded from 54 countries, giving written online responses. This article first summarises previously published findings from the survey regarding the range of ethical challenges experienced, then develops a new analysis of social workers' accounts of ethically challenging situations from a virtue ethics perspective. This analysis took a narrative ethics approach, treating respondents' accounts as stories featuring the tellers as moral agents, with implicit or explicit implications for their professional ethical identity and character. The article is illustrated with accounts from the 41 UK respondents, drawing particularly on two case examples. ETHICAL CONSIDERATIONS: Ethical approval was gained from Durham University and anonymity was ensured for participants. FINDINGS/RESULTS: This article explores the nature of the ethical space created during the pandemic showing how practitioners were able to draw more on 'inner resources' and professional discretion than usual, displaying virtues such as professional wisdom, care, respectfulness and courage as they took account of the specific contexts of their work, rather than simply adhering to blanket rules. CONCLUSION: Exploring practice through a virtue ethical lens provides valuable lessons for 'building back better' in social and health care professions.

Adult Drug Treatment Courts and Community-Level Drug Possession Arrests.

Though the literature largely recognizes adult drug treatment courts (ADCs) as beneficial to participants, with lower rates of recidivism and drug use, the question remains of how ADCs impact communities and how other institutions (e.g., law enforcement) react to their presence. This study extends previous work estimating higher arrests associated with ADCs, particularly for crimes involving higher degrees of law enforcement discretion. Results indicate lower drug possession arrest rates for White residents in rural communities, and higher in urban areas, generally, but especially for Black citizens. Though the exact source of these changes has yet to be determined, current analysis indicates larger effect sizes for arrests scaled per officer, as compared to per population, pointing toward changes in law enforcement behavior.

Unlimited Discretion: How Unchecked Bureaucratic Discretion Can Threaten Abortion Availability.

Previous research has assessed the impact of state regulations on abortion clinics and patients, but how bureaucrats implement them is less understood and is increasingly important as states arbitrate abortion regulation. The authors conducted a case study of how bureaucrats use discretion to implement state regulations on abortion, focusing on two abortion facilities in southwest Ohio from 2010 to 2022. Ohio abortion facilities are required to obtain a written transfer agreement, despite it offering no demonstrable health or safety benefits. The authors find that state requirements for obtaining variances-a process that allows abortion facilities to operate without a written transfer agreement-have become exceedingly difficult to comply with. The authors show how state statutes and administrative law have enabled bureaucrats to wield unlimited discretion and enforce arbitrary requirements. This unlimited bureaucratic discretion and accompanying administrative burden exacerbated clinic instability and threatened abortion availability in southwest Ohio for almost a decade. As implementation and interpretation of abortion policy is increasingly left to state bureaucrats and civil servants following the Supreme Court's Dobbs decision, how bureaucrats use discretion will influence clinic stability and abortion availability. The authors posit that unlimited bureaucratic discretion may exert greater influence on abortion availability across the nation as states scramble to clarify and implement policies after Dobbs.

Decision Making Within and Outside Standard Operating Procedures: Paradoxical Use of Operational Discretion in Firefighters.

OBJECTIVE: To understand how firefighters' use of rules (i.e., standard operating procedures [SOPs]) and deliberative decision making (i.e., operational discretion [OD]) interacts with acute stress. BACKGROUND: Current operational guidance for UK firefighters combines the provision of SOPs, for routine incidents, with the use of OD, under prescribed conditions (e.g., when there is a risk to human life). However, our understanding of the use of SOPs and OD is limited. METHODS: Incident commanders (ICs; n = 43) responded to simulated emergency incidents, which either licensed the use of OD or required use of a SOP. Video footage of IC behavior was used to code their response as involving a SOP or OD, while levels of acute stress were assessed using a blood-based measure and self-report. RESULTS: ICs were less likely to use OD selectively in the simulated emergency incident that licensed its use than in the one for which use of an SOP was appropriate; IC command level did not affect this pattern of results; and the incident that licensed OD resulted in more acute stress than the incident that required use of a SOP. CONCLUSION: SOPs and OD were not used in the manner prescribed by current operational guidance in simulated emergency incidents. APPLICATION: These results suggest that firefighter training in SOPs and OD should be augmented alongside personal resilience training, given the impact of stress on health and wellbeing, but also to improve the deployment of SOPs and OD under stress.

Expanding Mechanisms of Governance: Uncertainty and Risk in Police Decision-Making Strategies in the Pursuit of Specialized Peace Bonds.

This study examines police officers' decision-making practices through analyzing how they determine which offenders are candidates for an 810, or peace bond. This legal tool allows police officers to petition the courts for continued surveillance and conditions for offenders postrelease. Little, however, is offered in terms of assessment guidelines on how to make such determinations. As a result, police officers discretionary behaviors and additional legal factors play a key role in these determinations. Our findings advance the idea that "uncertainty" is the central object to be managed, and further complicate how risk is constructed and mobilized by suggesting that risk assessments result in over-precautionary practices.

Do moral intuitions influence judges' sentencing decisions? A multilevel study of criminal court sentencing in Pennsylvania.

The influence of judges' personal moral values on their sentencing decisions is of longstanding interest to researchers and the public. Few studies, however, have examined this influence empirically. Using a unique data set that combines a survey of 81 criminal court judges with archival data on their 40,385 criminal sentences over a 2-year period, and drawing on Moral Foundations Theory, we hypothesize that judges with strong care and fairness intuitions will sentence defendants less severely while judges with strong loyalty, authority, and sanctity intuitions will sentence defendants more severely. We further hypothesize that these effects will be heightened when the defendant is from a racial minority group. Results show that sentencing outcomes are largely independent of judges' moral intuitions, except that fairness intuitions tend to increase leniency, especially when the defendant is Black, and sanctity intuitions tend to decrease leniency. Implications for future research on sentencing are discussed.

The art of making the right exception to the "rule": Nurses' experiences with drug dispensing in nursing homes.

Nurses are key professionals in ensuring safe drug management in nursing homes, and their practice is regulated by a number of guidelines. The present study aimed to explore nurses' experiences of dispensing drugs to older people in nursing homes by using an exploratory qualitative design. Focus group interviews were conducted in three nursing homes in central Norway; the data were analyzed using qualitative content analysis. The results indicated that drug dispensing was perceived as a complicated process during which both anticipated and unforeseen challenges arose that influenced the nurses' abilities to follow professional standards. In these situations, the nurses had to apply their knowledge and make various adjustments based on conditions in the organization and the needs of individual patients. The findings have implications for facilitating nurses' working conditions and resources to avoid drug administration that limit the discretion of nurses and threaten patient safety in nursing homes.

Sentencing Policy, Social Values and Discretionary Justice.

Despite the recent consolidation of sentencing law and procedure, the fundamental values which underpin the policy and practice of sentencing in England and Wales have remained largely unchanged since the deserts-based model introduced by the Criminal Justice Act of 1991. It is argued that this paradigm is no longer appropriate and presents a significant impediment to reducing imprisonment and mainstreaming restorative forms of intervention within the criminal process. An alternative value-based approach is proposed to counter this trend, one that provides greater structural flexibility and empowers sentencers to engage more effectively with the social impact of penal intervention.

Three Issues in the Law of Contractual Discretion.

The new law of contractual discretion is developing apace. This article addresses three major issues in this dynamic field. First, the article propounds an analytical framework for understanding the nature and practice of reasonableness review in the contractual setting, based on doctrinal exegesis of the full run of cases on contractual discretion. Significantly, the analysis demonstrates that review of contractual discretion is characterised by a 'variable intensity' approach: the intensity with which courts scrutinise exercises of discretion is dependent on a series of contextual factors. Second, the article analyses the genus of the implied term, which imposes legal constraints on contractual decision-makers, arguing that the term is properly conceptualised as a term implied in law. Third, the article addresses the remedial consequences of non-compliance with implied fetters, identifying three different remedial models in the case law. The article challenges the common assertion that damages are the invariable remedy, arguing that an impugned exercise of discretion may be void or voidable.

Off the record: The invisibility work of doctors in a patient-accessible electronic health record information service.

In this article, we draw on Michael Lipsky's work on street-level bureaucrats and discretion to analyse a real case setting comprising an interview study of 30 Swedish doctors regarding their experiences of changes in clinical work following patients being given access to medical records information online. We introduce the notion of invisibility work to capture how doctors exercise discretion to preserve the invisibility of their work, in contrast to the well-established notion of invisible work, which denotes work made invisible by parties other than those performing it. We discuss three main forms of invisibility work in relation to records: omitting information, cryptic writing and parallel note writing. We argue that invisibility work is a way for doctors to resolve professional tensions arising from the political decision to provide patients with online access to record information. Although invisibility work is understood by doctors as a solution to government-initiated visibility, we highlight how it can create difficulties for doctors concerning accountability towards patients, peers and authorities.

The Factors that Motivate Law Enforcement's Use of Force: A Systematic Review.

Media attention relevant to law enforcement use of force in the last decade finally alerted the scientific community to the need for more research regarding law enforcement discretion and decision making. The purpose of this study was to synthesize the existing literature to explore the motivating factors for law enforcement use of force. This study will utilize a social-ecological framework to systematically examine factors that impact officer decisions to use force at the individual and community levels. The paper includes recommendations for research and practice through an equity lens that highlights the disparate use of force against men of color in particular. Interventions, trainings, education, and research to stop the promotion of perceived safety over justice will be highlighted.

Simple monetary rules: many strengths and few weaknesses.

This paper endeavors to examine the basic idea in Richard Epstein's book Simple Rules for a Complex World. It does so by considering a specific simple rule which was explicitly designed for complex world. A basic idea in Epstein's book is that the more complex is the world the better is the case for simple rules. To show this, he develops six simple rules pertaining to the rights of individuals, first possession, contracts, torts, government eminent domain and the power of taxation to provide public goods. This paper considers one rule rather than six rules, and it looks at monetary policy rather than policy in general. While the context is different, the case for simple rules made here provides a useful comparison with the case made by Epstein.

The ethics of inattention: revitalising civil inattention as a privacy-protecting mechanism in public spaces.

Societies evolve practices that reflect social norms of appropriateness in social interaction, for example when and to what extent one should respect the boundaries of another person's private sphere. One such practice is what the sociologist Erving Goffman called civil inattention-the social norm of showing a proper amount of indifference to others-which functions as an almost unnoticed yet highly potent privacy-preserving mechanism. These practices can be disrupted by technologies that afford new forms of intrusions. In this paper, we show how new networked technologies, such as facial recognition (FR), challenge our ability to practice civil inattention. We argue for the need to revitalise, in academic and policy debates, the role of civil inattention and related practices in regulating behaviour in public space. Our analysis highlights the relational nature of privacy and the importance of social norms in accomplishing and preserving it. While our analysis goes some way in supporting current calls to ban FR technology, we also suggest that, pending a ban and in light of the power of norms to limit what is otherwise technically possible, cultivating new practices of civil inattention may help address the challenges raised by FR and other forms of digital surveillance in public.

University as Secret Society: Becoming Faculty Through Discretion.

Becoming a professor is complicated by a lack of clear guidelines for promotion to permanent status and, paradoxically, a surplus of mechanisms for institutional transparency. Drawing on Lilith Mahmud's anthropologies of discretion applied to secret societies like the Italian Freemasons, this paper compares becoming a professor to an initiate's journey toward becoming a member of a secret society. Membership in both requires a balance between knowing who to know and knowing the codes of what goes said and unsaid. These ways of knowing may manifest in mentor/mentee relations, in informal networks and communities of practice, or in acts of compliance and resistance to the neoliberal university.

Understanding Misdemeanor Enforcement: The Roles of Calls for Service and Community Characteristics.

This study examines the roles of calls for service (i.e., police-related 911 calls) and community characteristics in explaining variation in enforcement rates for low-level, misdemeanor offenses, which make up the large majority of police enforcement activity. The study site is Prince George's County, Maryland, and the unit of analysis is the police department's 65 patrol beats, studied over a 10-year period, during 2006-2015. Overall, misdemeanor enforcement rates vary at the beat level, and that variation can be largely explained using a combination of indicators about community characteristics and calls for service. The findings indicate, though, that the calls for service rate is the most important variable in explaining misdemeanor enforcement variation. These findings inform both future research on police activity, and current policy debates about what drives enforcement rates and the role of discretion in enforcement outcomes.

Why teach sexuality education in school? Teacher discretion in implementing comprehensive sexuality education in rural Zambia.

BACKGROUND: Reproductive health problems such as HIV, unwanted pregnancy and unsafe abortion among adolescents are closely linked to insufficient knowledge about sexuality and reproduction and lack of access to contraceptives. Supported by international agencies, Zambia has introduced an ambitious nation-wide program for comprehensive sexuality education (CSE) to be implemented into ordinary school activities by teachers. The curriculum is firmly based in a discourse of sexual and reproductive rights, not commonly found in the public debate on sexuality in Zambia. This paper explores how teachers perceive the curriculum and practice discretion when implementing the CSE in mid-level schools in Nyimba district in Zambia. METHODS: Using a case study design, data were collected through in-depth interviews with 18 teachers and analyzed thematically drawing upon theories of discretion and policy implementation. RESULTS: Individual teachers make decisions on their own regarding what and when to teach CSE. This discretion implies holding back information from the learners, teaching abstinence as the only way of preventing pregnancy or cancelling sexuality education sessions altogether. Teachers' choices about the CSE program were linked to lack of guidance on teaching of the curriculum, especially with regards to how to integrate sexuality education into existing subjects. Limited prioritization of CSE in the educational sector was observed. The incompatibility of CSE with local norms and understandings about adolescent sexuality combined with teacher-parent role dilemmas emerged as problematic in implementing the policy. Limited ownership of the new curriculum further undermined teachers' motivation to actively include CSE in daily teaching activities. Use of discretion has resulted in arbitrary teaching thus affecting the acquisition of comprehensive sexual and reproductive health knowledge among learners. CONCLUSION: The CSE had limited legitimacy in the community and was met with resistance from teachers tasked with its' implementation. In order to enhance ownership to the CSE program, local concerns about the contents of the curriculum and the parent-teacher role dilemma must be taken into consideration. Not addressing these challenges may undermine the policy's intention of increasing knowledge about sexuality and reproduction and empowering adolescents to access contraceptive services and avoid unwanted pregnancies.

Lack of compassion or poor discretion? Ways of addressing malpractice.

In this article, our point of departure is the 'compassion crisis' in the National Health Service in the UK and the initiatives introduced in the aftermath of scandals that were intended to strengthen healthcare professionals' ability to show compassion. We look at the two main strategies, which we term the 'recruitment and staff development strategy' and the 'amelioration of the quality systems strategy' and the debate that has arisen related to them. Based on this analysis, we question whether compassion really is a helpful concept to understand the crisis and hence to underpin relevant strategies. We introduce the concept of discretion as an alternative and better concept to comprehend the situation. One of the benefits of the concept of discretion is that it clarifies how problems can be addressed, both as structural problems and as epistemic problems and how these aspects are intertwined. It also helps us to see how solving these problems is complicated and demands comprehensive, in-depth approaches, involving formative aspects related to healthcare education, as well as development of new healthcare policies.