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The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France., (Copyright © 2021. Published by Elsevier Masson SAS.)

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., (Copyright © 2020 Lambert, Yanikkaya Demirel, Keller, Preijers, Psarra, Schiemann, Özçürümez and Sack.)

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., (© The Author(s) 2020. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.)

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., (Copyright © 2019 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

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.

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., (© 2019 The Authors. Australasian Journal on Ageing published by John Wiley & Sons Australia, Ltd on behalf of AJA Inc.)

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., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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., (© 2019 The Authors. Australasian Journal on Ageing published by John Wiley & Sons Australia, Ltd on behalf of AJA Inc.)

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., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Editorial Department of Journal of Forensic Medicine.)

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.

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.

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., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

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.

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., Competing Interests: Conflict of interest: MRP, TRO, ARE, and JCP are employees of the American Board of Family Medicine., (© Copyright 2017 by the American Board of Family Medicine.)

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., Competing Interests: Conflict of interest: JCP, MRP, and TRO are employees of the ABFM., (© Copyright 2017 by the American Board of Family Medicine.)

Background: Evaluating the quality of postgraduate medical education (PGME) programs through accreditation is common practice worldwide. Accreditation is shaped by educational quality and quality management. An appropriate accreditation design is important, as it may drive improvements in training. Moreover, accreditors determine whether a PGME program passes the assessment, which may have major consequences, such as starting, continuing or discontinuing PGME. However, there is limited evidence for the benefits of different choices in accreditation design. Therefore, this study aims to explain how changing views on educational quality and quality management have impacted the design of the PGME accreditation system in the Netherlands., Methods: To determine the historical development of the Dutch PGME accreditation system, we conducted a document analysis of accreditation documents spanning the past 50 years and a vision document outlining the future system. A template analysis technique was used to identify the main elements of the system., Results: Four themes in the Dutch PGME accreditation system were identified: (1) objectives of accreditation, (2) PGME quality domains, (3) quality management approaches and (4) actors' responsibilities. Major shifts have taken place regarding decentralization, residency performance and physician practice outcomes, and quality improvement. Decentralization of the responsibilities of the accreditor was absent in 1966, but this has been slowly changing since 1999. In the future system, there will be nearly a maximum degree of decentralization. A focus on outcomes and quality improvement has been introduced in the current system. The number of formal documents striving for quality assurance has increased enormously over the past 50 years, which has led to increased bureaucracy. The future system needs to decrease the number of standards to focus on measurable outcomes and to strive for quality improvement., Conclusion: The challenge for accreditors is to find the right balance between trusting and controlling medical professionals. Their choices will be reflected in the accreditation design. The four themes could enhance international comparisons and encourage better choices in the design of accreditation systems.

Legislation and ISO 15189 international standard provide that the clinical laboratories shall organize the communication of the biological assay results, especially with the establishment of a list of critical assays, whose results shall be reported during doctor's on call period but also through restricting result transmission to biologically validated results. Actually continuous validation and immediate procession of the medical records belonging to patients in emergency situation are not always possible, because of the biologist's workload and the other activities he is responsible for. Based on the modified version of SH REF 04, we intend to export on the servers the results of critical assays during both the day time and doctor's on call period, as they are validated by the authorized technician, under the responsibility of the biologist in charge of validation. With this project, it will be possible at the same time to respond to the clinical requirements, and, for the biologist, to perform all his functions that are important to ensure the smooth running and the development of the laboratory.

Objectives: The aims of this discussion were to inform the medical community about the American Board of Cosmetic Surgery's ongoing attempts in Louisiana to achieve equivalency to American Board of Medical Specialties (ABMS) member boards so that its diplomates may use the term "board certified" in advertising and to ensure public safety by upholding the standards for medical board certification., Background: In 2011, Louisiana passed a truth in medical advertising law, which was intended to protect the public by prohibiting the use of the term "board certified" by improperly credentialed physicians. An American Board of Cosmetic Surgery diplomate petitioned the Louisiana State Board of Medical Examiners to approve a rule that would establish a pathway to equivalency for non-ABMS member boards, whose diplomates have not completed training approved by the Accreditation Council for Graduate Medical Education (ACGME) in the specialty they are certifying. Physicians and physician organizations representing multiple specialties (facial plastic and reconstructive surgery, otolaryngology [head and neck surgery], orthopedic spine surgery, pediatric neurosurgery, dermatology, and plastic surgery) urged the Louisiana State Board of Medical Examiners to clarify its advertising policy, limiting the use of the term "board certified" to physicians who have completed ACGME-approved training in the specialty or subspecialty named in the certificate., Discussion: The public equates the term "board certified" with the highest level of expertise in a medical specialty. When a certifying board does not require completion of ACGME or American Osteopathic Association (AOA)-accredited training in the specialty it certifies, the result is an unacceptable degree of variability in the education and training standards applied to its diplomates. Independent, third-party oversight of certifying boards and training programs is necessary to ensure quality standards are upheld. Any system that assesses a non-ABMS member or non-AOA-certified board for equivalency approval must ensure that the training and qualifications required by the non-ABMS or AOA board are equivalent in scope, content, and duration to those required by the ABMS and AOA. This issue must not be misconstrued as a "turf battle" between physicians of 2 competing specialties. Preserving the legitimacy of board certification is incumbent upon all medical specialties and subspecialties. This argument is a truthful, principled defense of the legitimacy of board certification.

The Department of Veterans Affairs (VA) is amending its regulations concerning recognition of certain national, State, and regional or local organizations for purposes of VA claims representation. Specifically, this rulemaking allows the Secretary to recognize tribal organizations in a similar manner as the Secretary recognizes State organizations. The final rule allows a tribal organization that is established and funded by one or more tribal governments to be recognized for the purpose of providing assistance on VA benefit claims. In addition, the final rule allows an employee of a tribal government to become accredited through a recognized State organization in a similar manner as a County Veterans' Service Officer (CVSO) may become accredited through a recognized State organization. The effect of this action is to address the needs of Native American populations who are geographically isolated from existing recognized Veterans Service Organizations (VSOs) or who may not be utilizing other recognized VSOs due to cultural barriers or lack of familiarity with those organizations.

Objective: According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated., Methods: National and regional legislation governing biomedical research was analysed., Results: No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation., Discussion: Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures., (Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.)

The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA).

The rapid development of medical science and health care practice, the need to improve the quality of health care, the ongoing modernization of education was the basis for scientfic rationale and implementation of the system of continuous medical education, which will be gradually expanded to cover individuals who have undergone 2016 accredited specialist.

. The evolution of the assessment and development of nursing competences in the Italian health-care system. The issue of the skills, in health care organizations, received a boost in the last 15 years as a result of contractual innovations that recognized different career levels in the nursing profession, and of the widespread dissemination of quality systems for certification or accreditation for excellence. These events prompted organizations to assess the competence of their professionals. A further stimulus was given by the recent debate on nursing sensitive outcomes, by the changes in patients' needs and by the increased production of knowledge from the nursing profession which contributed to an increase of competences and to their expanded role. To improve patients' care and avoid conflicts, and to maximize the benefits to users, professionals need to learn to work together, integrating and respecting roles and competences.

Background: Antinuclear antibodies (ANA) are useful biomarkers for the diagnosis and the monitoring of rheumatic diseases. The American College of Rheumatology has stated that indirect immunofluorescence (IIF) analysis remains the gold standard for ANA screening. However, IIF is time consuming, subjective, not fully standardized and presents several issues for accreditation which is the process leading to ISO 15189 certification for medical laboratories. We propose an innovative tool for accreditation by using the quantitative evaluation of the automated image capture and analysis "ICARE" (Immunofluorescence for Computed Antinuclear antibody Rational Evaluation)., Methods: We established the optimal screening dilution (1:160) and a fluorescence index (FI) cutoff for ICARE on a cohort of 91 healthy blood donors. Then, we evaluated performance of ICARE on a routine cohort of 236 patients. Precision parameters of ANA detection by IIF were evaluated according to ISO 15189., Results: ICARE showed an excellent concordance with visual evaluation (88%, Kappa=0.76) and significantly discriminated between weak to moderate (1:160-1:320 titers) and high (>1:320 titers) ANA levels. A significant correlation was found between FI and ANA titers (Spearman's ρ=0.67; P<0.0001). Using ICARE, we reported precision parameters such as repeatability (CV<13.8%) and reproducibility (CV<13.1%) as well as absence of inter-sample contamination for ANA detection by IIF according to ISO 15189 standards., Conclusions: ICARE offers a precious help for the accreditation of IIF qualitative methods. This innovative quantitative approach is in adequacy with the process of continuous improvement of the quality of clinical laboratories., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Besides the rapid development of healing procedures and healthcare, efficiency of care, institutional performance and safe treatment are receiving more and more attention in the 21st century. Accreditation, a scientifically proven tool for improving patient safety, has been used effectively in healthcare for nearly a hundred years, but only started to spread worldwide since the 1990s. The support and active participation of medical staff are determining factors in operating and getting accross the nationally developed, upcoming Hungarian accreditation system. However, this active assistance cannot be expected without the participants' understanding of the basic goals and features of the system. The presence of the ISO certification in Hungary, well-known by healthcare professionals, further complicates the understanding and orientation among quality management and improvement systems. This paper aims to provide an overview of the history, goals, function and importance of healthcare accreditation, and its similarities and differences regarding ISO certification.

We present, on behalf of EuroGentest and the European Society of Human Genetics, guidelines for the evaluation and validation of next-generation sequencing (NGS) applications for the diagnosis of genetic disorders. The work was performed by a group of laboratory geneticists and bioinformaticians, and discussed with clinical geneticists, industry and patients' representatives, and other stakeholders in the field of human genetics. The statements that were written during the elaboration of the guidelines are presented here. The background document and full guidelines are available as supplementary material. They include many examples to assist the laboratories in the implementation of NGS and accreditation of this service. The work and ideas presented by others in guidelines that have emerged elsewhere in the course of the past few years were also considered and are acknowledged in the full text. Interestingly, a few new insights that have not been cited before have emerged during the preparation of the guidelines. The most important new feature is the presentation of a 'rating system' for NGS-based diagnostic tests. The guidelines and statements have been applauded by the genetic diagnostic community, and thus seem to be valuable for the harmonization and quality assurance of NGS diagnostics in Europe.

This final rule revises the survey, certification, and enforcement procedures related to CMS oversight of national accrediting organizations (AOs). The revisions implement certain provisions under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The revisions also clarify and strengthen our oversight of AOs that apply for, and are granted, recognition and approval of an accreditation program in accordance with the statute. The rule also extends some provisions, which are applicable to Medicare-participating providers, to Medicare-participating suppliers subject to certification requirements, and clarifies the definition of "immediate jeopardy."

In 2016, provision is made for the transition for an accreditation system for all health workers to have individual permits for specific kinds of medical activities. Regular accreditation of health workers is one of the constituents of medical education, which is being intensively elaborated by the Ministry of Health of Russia jointly with a professional community by the module principle of using an accumulation system of valid credits. Despite the fact that higher educational establishments belong to different agencies, educational programs for physicians, criteria and procedures for their accreditation must be uniform. In this connection, there is today's challenge of methodological and methodical approaches to defining criteria for the accreditation of specialists of healthcare facilities of the Ministry of Health of Russia, bodies and institutions of the Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare. In the context of systemic and functional methodological approaches, the paper shows a procedure for defining criteria for the accreditation of specialists (in case of medical parasitologists).

The paper considers the functional aspects of a biological component in programs for training specialists in the area of Parasitology for accreditation within the current enactments, including those on modernization of public health and additional professional education. The working program of the module "Fundamental Disciplines" has been used as an example to outline approaches to molding a medical parasitologist's capacity and readiness to solve professional tasks on the basis of knowledge of fundamental disciplines: biology, immunology, and medical geography. Education fundamentalization is shown to suggest more unsupervised work of a learner in the teaching process. The fundamental constituent of a biological component of the 'programs for training learners in the specialty of Parasitology for accreditation is shown in the interaction of all sections of this area with special and allied subjects.

Competency is the ability to use a structured set of knowledge, skills, and attitudes in a specific professional context, or in professional training. Over the past 10 years there has been an acceleration of the trend towards a competency-based design of the education of healthcare professionals, rather than just defining learning objectives or relying on the content of disciplinary programs. The choice for a competency-based curriculum is not only the result of a changed pedagogical vision, but also an answer to the request of accountability toward society about how are the professionals trained and also to allow comparability between universities and nations. In recent years, many international initiatives have defined competency models for medicine and more specifically for public health. This article summarizes these initiatives, putting them in the context of the evolving Italian legislation.

As many low- and middle-income countries (LMICs) pursue health care reforms in order to achieve universal health coverage (UHC), development of national accreditation systems has become an increasingly common quality-enhancing strategy endorsed by payers, including Ministries of Health. This article describes the major considerations for health system leaders in developing and implementing a sustainable and successful national accreditation program, using the 20-year evolution of the Thai health care accreditation system as a model. The authors illustrate the interface between accreditation as a continuous quality improvement strategy, health insurance and other health financing schemes, and the overall goal of achieving universal health coverage.

In 1960, "Anesthesiology" was accredited as a "specially approved medical specialty" for approving registered anesthesiologists. Exclusive training for more than two years of anesthesia under an adequate mentor is required for candidates to be qualified as registered anesthesiologists. In 1963, the Japan Society of Anesthesiology (JSA) established the system to qualify board certificated anesthesiologists as proper mentors responsible for the training of the candidates. This ranks as one of the most significant events in the JSA history and the society launched the first qualification system in the history of medical practice in Japan. Every member of the present society should fully understand the hidden background of the qualification system of the specialty for achieving greater social recognition of anesthesiologists in this country.

Since the radical changes in Italian mental health law in the 1970s, quality assurance models have gained consensus as the most suitable service assessment tool. In the 1990s, the whole Italian National Health System changed into a corporate model, and an accreditation system was implemented.The Italian Association for Quality and Accreditation in Mental Health (Associazione Italiana per la Qualità e l'Accreditamento in Salute Mentale [QUASM]) was founded in 1984, and since then, it offers consultation and support for Mental Health Departments and Regional Governments to help them to develop psychiatric programs, self-evaluation, educational programs, and professional peer-model accreditation. The QUASM accreditation manual has now gone through several revisions, the last in 2008. Until 2008, QUASM was successful in promoting quality and facilitating both institutional and professional accreditation. However, radical changes triggered by financial crisis have jeopardized quality assurance implementation. Nowadays, the challenge for QUASM is to maintain quality and accreditation geared to excellence against prevailing leveling trends.

Introduction: Recent years have seen an increasing number of foreign doctors starting to practice medicine in German hospitals (or more rarely, in surgeries). In order to be granted the German license to practice medicine, doctors with a medical degree from outside the European Union have to undergo an equivalency examination. The supervisory authority for this is the examination office of the relevant federal state, which is why different procedures are being applied in the individual states. The aim of this paper is to point out the problems that frequently arise when conducting this specialist exam and to make suggestions as to how to improve the quality of the procedure., Method: 6 senior professors from the examination boards of the 4 medical schools in Baden-Wuerttemberg formed a focus group and discussed the difficulties associated with the exam, recorded problems in its actual implementation and then analysed the minutes of the meeting in a results-based manner in order to compile proposals for optimisation., Results: In view of the deficits in subject knowledge, general communication skills and specific communication skills, the difficulties of the current recognition procedure and the existing equivalency exam fall into 3 categories: structure and content of the exam, examiners and exam candidates., Conclusions: In consultation with the State Examination Office Stuttgart, some processes for optimisation have been devised, e. g., to develop a special curriculum which could be used for guidance and to recruit more examiners. The recommendations of the focus group from Baden-Wuerttemberg are an important step towards more transparency and possibly towards a Germany-wide standardisation of this exam., (© Georg Thieme Verlag KG Stuttgart · New York.)

Independent health facilities ("IHFs") are an important part of Canada's health care system existing at the interface of public and private care. They offer benefits to individual patients and the public at large, such as improved access to care, reduced wait times, improved choice in the delivery of care, and more efficient use of health care resources. They can also provide physicians greater autonomy, control of resources, and opportunity for profit compared to other practice settings, particularly because IHFs can deliver services outside of publicly-funded health care plans. IHFs also present challenges, particularly around quality of care and patient safety, and the potential to breach the principles of "Medicare" under the Canada Health Act. Various measures are in place to address these challenges, while still enabling the benefits IHFs can offer. IHFs are primarily regulated and overseen at the provincial level through legislation, regulations and provincial medical regulatory College by-laws. Health Canada is responsible for administering the overarching framework for "Medicare". Oversight and regulatory provisions vary across Canada, and are notably absent in the Maritime provinces and the territories. This article provides an overview of specific provisions related to IHFs across the country and how they can co-exist with the Canada Health Act.