Radiation therapy: Regulatory framework and constraints.

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France.

Flow Cytometric Analyses of Lymphocyte Markers in Immune Oncology: A Comprehensive Guidance for Validation Practice According to Laws and Standards.

Many anticancer therapies such as antibody-based therapies, cellular therapeutics (e.g., genetically modified cells, regulators of cytokine signaling, and signal transduction), and other biologically tailored interventions strongly influence the immune system and require tools for research, diagnosis, and monitoring. In flow cytometry, in vitro diagnostic (IVD) test kits that have been compiled and validated by the manufacturer are not available for all requirements. Laboratories are therefore usually dependent on modifying commercially available assays or, most often, developing them to meet clinical needs. However, both variants must then undergo full validation to fulfill the IVD regulatory requirements. Flow cytometric immunophenotyping is a multiparametric analysis of parameters, some of which have to be repeatedly adjusted; that must be considered when developing specific antibody panels. Careful adjustments of general rules are required to meet legal and regulatory requirements in the analysis of these assays. Here, we describe the relevant regulatory framework for flow cytometry-based assays and describe methods for the introduction of new antibody combinations into routine work including development of performance specifications, validation, and statistical methodology for design and analysis of the experiments. The aim is to increase reliability, efficiency, and auditability after the introduction of in-house-developed flow cytometry assays.

The development of hospital accreditation in low- and middle-income countries: a literature review.

Hospital accreditation has been transferred from high-income countries (HICs) to many low- and middle-income countries (LMICs), supported by a variety of advocates and donor agencies. This review uses a policy transfer theoretical framework to present a structured analysis of the development of hospital accreditation in LMICs. The framework is used to identify how governments in LMICs adopted accreditation from other settings and what mechanisms facilitated and hindered the transfer of accreditation. The review examines the interaction between national and international actors, and how international organizations influenced accreditation policy transfer. Relevant literature was found by searching databases and selected websites; 78 articles were included in the analysis process. The review concludes that accreditation is increasingly used as a tool to improve the quality of healthcare in LMICs. Many countries have established national hospital accreditation programmes and adapted them to fit their national contexts. However, the implementation and sustainability of these programmes are major challenges if resources are scarce. International actors have a substantial influence on the development of accreditation in LMICs, as sources of expertise and pump-priming funding. There is a need to provide a roadmap for the successful development and implementation of accreditation programmes in low-resource settings. Analysing accreditation policy processes could provide contextually sensitive lessons for LMICs seeking to develop and sustain their national accreditation programmes and for international organizations to exploit their role in supporting the development of accreditation in LMICs.

Evaluation and Countermeasures of the Implementation of Forensic Clinical Identification Standards Based on the Perspective of Accreditation.

ABSTRACT: The new Standardization Law, implemented in 2018, has added a standard post-implementation evaluation system, aiming to continuously improve the quality of standards through post-implementation evaluation. Standards in the forensic science field are closely related to accreditation activities. Forensic science standards are not only the criteria on which accreditation activities are carried out, but also one of the key contents of the inspection of forensic science institutions in accreditation activities. Since 2018, the certification and accreditation policies in the forensic science field have also been changed, which has brought impacts on the construction of a standard system based on accreditation.This paper analyzes the standard data from China National Accreditation Center from Conformity Assessment on forensic clinical identification accreditation assessment. It points out that the current coverage of laboratory accreditation activities is limited, the development in different provinces is unbalanced, and there is overlap and crossover in the standards in use. It is emphasized that the construction of the national forensic science standardization technical committee, the improvement of the forensic science standard system, the establishment of the standard implementation evaluation index system, and promotion of the coordination of standards, and the certifications and accreditations should be accelerated, in order to continue to promote the standardization and accreditation activities in the field of forensic science.

Accreditation of endocrine surgery units.

BACKGROUND/PURPOSE: A key measure to maintain and improve the quality of healthcare is the formal accreditation of provider units. The European Society of Endocrine Surgeons (ESES) therefore proposes a system of accreditation for endocrine surgical centers in Europe to supplement existing measures that promote high standards in the practice in endocrine surgery. METHODS: A working group analyzed the current healthcare situation in the field of endocrine surgery in Europe. Two surveys were distributed to ESES members to acquire information about the structure, staffing, caseload, specifications, and technology available to endocrine surgery units. Further data were sought on tracer diagnoses for quality standards, training provision, and research activity. Existing accreditation models related to endocrine surgery were included in the analysis. RESULTS: The analysis of existing accreditation models, available evidence, and survey results suggests that a majority of ESES members aspire to a two-level model (termed competence and reference centers), sub-divided into those providing neck endocrine surgery and those providing endocrine surgery. Criteria for minimum caseload, number and certification of staff, unit structure, on-site collaborating disciplines, research activities, and training capacity for competence center accreditation are proposed. Lastly, quality indicators for distinct tracer diagnoses are defined. CONCLUSIONS: Differing healthcare structures, existing accreditation models, training models, and varied case volumes across Europe are barriers to the conception and implementation of a pan-European accreditation model. However, there is consensus on accepted standards required for accrediting an ESES competence center. These will serve as a basis for first-stage accreditation of endocrine surgery units.

How provider organisations interpret regulation in the context of residential dementia aged care.

OBJECTIVE: To explore how Australian residential dementia aged care providers respond to regulation via organisational culture, level, processes and interpretation. METHODS: Observation took place in three provider organisations. Qualitative, semi-structured in-depth interviews were conducted with aged care staff (n = 60) at three different levels of each organisation: senior management from three head offices (n = 17), facility management (n = 13) and personal care workers (n = 30) from eight residential care facilities. RESULTS: Orientations towards regulation included the following: "above and beyond;" "pushing back;" and "engineering out." Regulation was interpreted differently depending on the level of authority within an organisation where boundaries were managed according to strategic, operational and interactional priorities. DISCUSSION: Examining regulation within an organisational context and at different staff levels suggests ways to balance dementia care with regulatory control. Both generate stress, mitigated by culture and interdependent role differentiation.

An examination of organisational policies for healthcare and lifestyle decision-making among Australian aged care providers.

OBJECTIVE: Examine policies of aged care organisations relating to healthcare and lifestyle decision-making. METHODS: Seven aged care organisations submitted policy documents. Policies were analysed using the Australian Law Reform Commission (ALRC) "Decision-Making Principles" as a framework. Senior staff (N = 9) with policy development roles participated in follow-up interviews. RESULTS: The structure and content of policy documents varied significantly between organisations. Most acknowledged the need to support the rights of care recipients in decision-making; however, the nature of this support was often unclear. Interview themes included factors relating to "organisational contexts" "policy development and implementation" and "ethical challenges." An overarching theme among high-performing organisations was "proactive response aimed at pre-empting decision-making dilemmas". We provide recommendations for policy development, including a self-assessment audit tool. CONCLUSION: Aged care provider organisations may need to review policies in the areas of healthcare and lifestyle decision-making to meet current best practice principles.

[Successful completion of an ISO 9001 v 2015 certification process in clinical investigation research]. / Réussir une démarche de certification ISO 9001 v 2015 en investigation clinique.

Clinical investigation at the University Hospital of Nantes is carried out within the investigation department, which consists of coordination and 24 clinical research teams gathered at four different hospital sites. The Clinical Investigation Units are all equipped with a Quality Management System. This has been in place for more than 12 years and was initially created for the Clinical Investigation Units of the Clinical Investigation Centre (CIC 1413) in Nantes and then transposed in 2013, to the emerging Clinical Investigation Units. OBJECTIVE: In order to evaluate the performance of this quality approach applied to all UHC investigations, the Investigation Department is committed to obtaining an ISO 9001:2015 certification. METHODS: The quality division of the investigation department conducted the project according to a methodology, based on internal and external evaluations to determine an inventory and the retro-planning of the certification approach. RESULTS: The scope of the certification involved the investigation department of the University Hospital: 24 clinical investigation units, over 500 medical staff, 150 non-medical staff. In our certification approach, the client was the promoter of the clinical study. The process lasted 18 months and included phases of training and awareness-raising for all the staff involved. The quality management system of the investigation department has been revised and improved in accordance with current regulations. The Investigation Department obtained the ISO 9001:2015 certification for all clinical investigations at the Nantes University Hospital in June 2017 without any non-compliance. CONCLUSION: Our work shows that the investigation department has successfully adapted the ISO 9001:2015 standard to institutional clinical research. The certification for specific activities in clinical investigation is the guarantee of an optimized and relevant organization for the safety of volunteers, participating in clinical research as well as the scientific quality of the research and contributes to the satisfaction of sponsors.

Fellowship or Family? A Comparison of Residency Leave Policies With the Family and Medical Leave Act.

BACKGROUND: In 1993, the Family and Medical Leave Act (FMLA) mandated 12 weeks of unpaid, job-protected leave. The current impact of taking 12 weeks of leave during residency has not been evaluated. METHODS: We examined the 2018 Accreditation Council for Graduate Medical Education (n = 24) specialty leave policies to determine the impact of 6- and 12-week leave on residency training, board eligibility, and fellowship training. We compared our findings with a 2006 study. RESULTS: In 2018, five (21%) specialties had policy language regarding parental leave during residency, and four (16%) had language regarding medical leave. Median leave allowed was 4 weeks (IQR 4-6). Six specialties (25%) decreased the number of weeks allowed for leave from 2006 to 2018. In 2006, a 6-week leave would cause a 1-year delay in board eligibility in six specialties; in 2018, it would not cause delayed board eligibility in any specialty. In 2018, a 12-week (FMLA) leave would extend training by a median of 6 weeks (mean 4.1, range 0-8), would delay board eligibility by 6-12 months in three programs (mean 2.25, range 0-12), and would delay fellowship training by at least 1 year in 17 specialties (71%). The impact of a 12-week leave was similar between medical and surgical specialties. CONCLUSIONS: While leave policies have improved since 2006, most specialties allow for 6 weeks of leave, less than half of what is mandated by the FMLA. Moreover, a 12-week, FMLA-mandated leave would cause significant delays in board certification and entry into fellowship for most residency programs.

Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations. Final rule with comment period.

This final rule with comment period updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per- visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. This rule also: Updates the HH PPS case-mix weights for calendar year (CY) 2019 using the most current, complete data available at the time of rulemaking; discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CYs 2014 through 2017; finalizes a rebasing of the HH market basket (which includes a decrease in the labor-related share); finalizes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123) hereinafter referred to as the "BBA of 2018"; finalizes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services; and finalizes the definition of "remote patient monitoring" and the recognition of the costs associated with it as allowable administrative costs. This rule also summarizes the case-mix methodology refinements for home health services beginning on or after January 1, 2020, which includes the elimination of therapy thresholds for payment and a change in the unit of payment from a 60-day episode to a 30-day period, as mandated by section 51001 of the Bipartisan Budget Act of 2018. This rule also finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model. In addition, with respect to the Home Health Quality Reporting Program, this rule discusses the Meaningful Measures Initiative; finalizes the removal of seven measures to further the priorities of this initiative; discusses social risk factors and provides an update on implementation efforts for certain provisions of the IMPACT Act; and finalizes a regulatory text change regarding OASIS data. For the home infusion therapy benefit, this rule finalizes health and safety standards that home infusion therapy suppliers must meet; finalizes an approval and oversight process for accrediting organizations (AOs) that accredit home infusion therapy suppliers; finalizes the implementation of temporary transitional payments for home infusion therapy services for CYs 2019 and 2020; and responds to the comments received regarding payment for home infusion therapy services for CY 2021 and subsequent years. Lastly, in this rule, we are finalizing only one of the two new requirements we proposed to implement in the regulations for the oversight of AOs that accredit Medicare-certified providers and suppliers. More specifically, for reasons set out more fully in the section X. of this final rule with comment period, we have decided not to finalize our proposal to require that all surveyors for AOs that accredit Medicare-certified providers and suppliers take the same relevant and program-specific CMS online surveyor training that the State Agency surveyors are required to take. However, we are finalizing our proposal to require that each AO must provide a written statement with their application to CMS, stating that if one of its fully accredited providers or suppliers, in good- standing, provides written notification that they wish to voluntarily withdraw from the AO's CMS-approved accreditation program, the AO must continue the provider or supplier's current accreditation until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.

[Medical biology in the face of the evolution of health care needs]. / Rapport des Académies nationales de médecine et de pharmacie sur la biologie médicale La biologie médicale face aux défis de l'évolution des besoins de santé.

Since the publication of the ordinance of January 13th 2010, ratified by the law of May 30th 2013, medical biology in France has undergone a massive restructuration with the emergence of groups of several hundred laboratories. This evolution, which leads to a considerable reduction in the number of structures, causes numerous problems related to increased industrialization and financialization, difficulties of accreditation and disappearance of the proximity link between the biologist and the prescriber or the patient. It also leads to a clear disaffection of students, especially medical students, for this specialty whose medical character has been clearly affirmed by the law. This report takes stock of the current situation of medical biology and makes recommendations to strengthen the role of the medical biologist in the health system and patients' care.

How are complementary health professions regulated in Australia? An examination of complementary health professions in the national registration and accreditation scheme.

OBJECTIVES: This study aims to provide an empirical examination of how complementary medicine practice in Australia is actually regulated under the current national registration model. METHODS: Data was obtained from Australian Health Practitioner Regulation Agency (AHPRA) Annual Reports for the years 2011/12-2014/15 and supplemented by the Chinese Medical Registration Board of Victoria (CMRBV) Annual Reports in 2011/12 for Chinese Medicine complaints. The data analysed includes complaint statistics, stage of closure of complaints and the outcome of complaints concerning Chinese medicine, chiropractic and osteopathy under the National Law. RESULTS: During 2014-2015 the number of complaints per 100 registrants for was highest for the medical board (4.4), while much lower for the chiropractic (1.5), osteopath (0.7) and Chinese medicine (0.5) boards. For conventional boards, 58% of complaints were closed at the assessment stage, while 57%, 29% and 16% of complaints to the osteopath, Chinese medicine and chiropractic boards respectively were closed at the assessment stage. The decision to suspend or cancel registration of health professionals was 17% from the Chinese medicine board, 14% from the Osteopathy Board, 1.5% from the chiropractor board and 0.6% from the medical board. CONCLUSION: It appears that complementary medicine practitioner regulation works at least as well as conventional regulation, and at most complementary medicine boards take a stricter interpretation of misconduct though more research would need to be undertaken to state this definitively. Our findings indicate that the public are using the statutory complaint mechanisms available to them with respect to the three CM groups.

What Regulatory Requirements and Existing Structures Must Change If Competency-Based, Time-Variable Training Is Introduced Into the Continuum of Medical Education in the United States?

As competency-based medical education is adopted across the training continuum, discussions regarding time-variable medical education have gained momentum, raising important issues that challenge the current regulatory environment and infrastructure of both undergraduate and graduate medical education in the United States. Implementing time-variable medical training will require recognizing, revising, and potentially reworking the multiple existing structures and regulations both internal and external to medical education that are not currently aligned with this type of system. In this article, the authors explore the impact of university financial structures, hospital infrastructures, national accrediting body standards and regulations, licensure and certification requirements, government funding, and clinical workforce models in the United States that are all intimately tied to discussions about flexible training times in undergraduate and graduate medical education. They also explore the implications of time-variable training to learners' transitions between medical school and residency, residency and fellowship, and ultimately graduate training and independent practice. Recommendations to realign existing structures to support and enhance competency-based, time-variable training across the continuum and suggestions for additional experimentation/demonstration projects to explore new training models are provided.

The Single Graduate Medical Education (GME) Accreditation System Will Change the Future of the Family Medicine Workforce.

BACKGROUND: Due to the Accreditation Council for Graduate Medical Education (ACGME)/American Osteopathic Association (AOA) single-accreditation model, the specialty of family medicine may see as many as 150 programs and 500 trainees in AOA-accredited programs seek ACGME accreditation. This analysis serves to better understand the composition of physicians completing family medicine residency training and their subsequent certification by the American Board of Family Medicine. METHODS: We identified residents who completed an ACGME-accredited or dual-accredited family medicine residency program between 2006 and 2016 and cross-tabulated the data by graduation year and by educational background (US Medical Graduate-MD [USMG-MD], USMG-DO, or International Medical Graduate-MD [IMG-MD]) to examine the cohort composition trend over time. RESULTS: The number and proportion of osteopaths completing family medicine residency training continues to rise concurrent with a decline in the number and proportion of IMGs. Take Rates for USMG-MDs and USMG-IMGs seem stable; however, the Take Rate for the USMG-DOs has generally been rising since 2011. CONCLUSIONS: There is a clear change in the composition of graduating trainees entering the family medicine workforce. As the transition to a single accreditation system for graduate medical education progresses, further shifts in the composition of this workforce should be expected.

Performance of Graduating Residents on the American Board of Family Medicine Certification Examination 2009-2016.

In response to growing concern about the declining performance on the American Board of Family Medicine Certification Examination, several strategies were employed to assist program directors with preparing their residents to take the examination. The effect of these efforts seems to have resulted in significant improvement in performance.