[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.

Policies and practices in haemostasis testing among laboratories in Croatia: a survey on behalf of a Working Group for Laboratory Coagulation of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

INTRODUCTION: The objective of this survey was to assess current policies and practice in haemostasis testing among both hospital and outpatient laboratories in Republic of Croatia. MATERIALS AND METHODS: A questionnaire with seventy questions divided into nine sections was created in May 2015. Participants were asked about their practice related to test request form, sample collection, prothrombin time (PT) and activated partial thromboplastin time assays, other individual haemostasis assays, point-of-care testing (POCT), reporting of coagulation tests results and quality assurance of procedures, the personnel and other laboratory resources, as well as on issues related to education and implementation of additional coagulation assays in their laboratory. The survey was administered and data were collected between June and September 2015. RESULTS: A total survey response rate was 104/170 (61.2%). Most respondents were faced with incomplete information on prescribed therapy and diagnosis on the test request or inappropriate samples withdrawn on distant locations, but also do not have protocols for handling samples with high haematocrit values. Reporting of PT-INR and D-dimer results was different between laboratories. Although almost all laboratories developed a critical value reporting system, reporting a value to general practitioners is still a problem. Result on coagulation POCT testing showed that not all devices were supervised by laboratories, which is not in compliance with Croatian Chamber of Medical Biochemistry acts. CONCLUSION: Obtained results highlighted areas that need improvement and different practice patterns in particular field of haemostasis testing among laboratories. A harmonization of the overall process of haemostasis testing at national level should be considered and undertaken.

Confidence level in venipuncture and knowledge on causes of in vitro hemolysis among healthcare professionals.

INTRODUCTION: This study aimed to assess confidence level of healthcare professionals in venipuncture and their knowledge on the possible causes of in vitro hemolysis. MATERIALS AND METHODS: A sample of 94 healthcare professionals (nurses and laboratory technicians) participated in this survey study. A four-section questionnaire was used as a research instrument comprising general information for research participants, knowledge on possible causes of in vitro hemolysis due to type of material used and venipuncture technique and specimen handling, as well as assessment of healthcare professionals' confidence level in their own ability to perform first and last venipuncture. RESULTS: The average score on the knowledge test was higher in nurses' than in laboratory technicians (8.11±1.7, and 7.4±1.5, respectively). The difference in average scores was statistically significant (P=0.035) and Cohen's d in the range of 0.4 indicates that there is a moderate difference on the knowledge test among the health care workers. Only 11/94 of healthcare professionals recognized that blood sample collection from cannula and evacuated tube is method which contributes most to the occurrence of in vitro hemolysis, whereas most risk factors affecting occurrence of in vitro hemolysis during venipuncture were recognized. There were no significant differences in mean score on the knowledge test in relation to the confidence level in venipuncture (P=0.551). CONCLUSION: Confidence level at last venipuncture among both profiles of healthcare staff was very high, but they showed insufficient knowledge about possible factors affecting hemolysis due to materials used in venipuncture compared with factors due to venipuncture technique and handling of blood sample.

[The metrological support of medical laboratory activity].

The article discusses the methodological approaches in implementing of regulations of the Federal law FZ-102 "On the support of unity of measurements in the area of laboratory medicine "from the positions of GOSTK ISO 9001-2008 "The systems of quality management. Requirements" and GOST K ISO 15189-2009 "medical laboratories. The particular requirements to quality and competence". The application of GOSTK ISO 18113.1-5 "The medicine items for diagnostic in vitro. Information provided by manufacturer (marking)" neatly assigns the responsibility for support of metrological correctness of laboratory measurements.

Perspectives on quality control, risk management, and analytical quality management.

Quality control (QC) practices are changing in US laboratories as Centers for Medicare and Medicaid Services adopts individualized QC plans as a new option for compliance with the Clinical Laboratory Improvement Amendments regulations. The Joint Commission provides general guidance for applying risk management in health care organizations. The EP23A (Evaluation Protocol 23A) document from the Clinical and Laboratory Standards Institute provides specific guidance on the use of risk management for developing analytical QC plans. Medical laboratories should integrate risk management tools with existing quality management techniques and activities to provide an overall plan for analytical quality management.

Developing risk-based quality control plans: an overview of CLSI EP23-A.

What constitutes quality control (QC) in the clinical laboratory has expanded from being focused on the testing of QC samples to managing the risks of reporting incorrect patient results. To effectively implement this expanded vision of QC, the techniques of risk management are important tools. In 2011, the Clinical and Laboratory Standards Institute published EP23-A, Laboratory Quality Control Based on Risk Management, providing an introduction to risk management techniques and guidance on developing a risk-based QC plan. This article outlines the steps in developing and using a risk based QC plan based on the EP23 model.

Satisfying regulatory and accreditation requirements for quality control.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires all US clinical laboratories that test "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..." to be regulated. The CLIA mandates are site neutral; based on test complexity; and focus on the three phases of the testing process (preanalytical, analytical, and postanalytical). Many testing sites choose to meet the CLIA requirements by following the testing standards of a professional accreditation organization deemed by the Centers for Medicare and Medicaid Services. The three principal organizations are The Joint Commission, the College of American Pathologists, and COLA.

The long and winding regulatory road for laboratory-developed tests.

"High complexity" clinical laboratories are approved under the Clinical Laboratory Improvement Amendments to develop, validate, and offer a laboratory-developed test (LDT) for clinical use. The Food and Drug Administration considers LDTs to be medical devices under their regulatory jurisdiction, and that at least certain LDTs should be subject to greater regulatory scrutiny. This review describes the current regulatory framework for LDTs and suggests ways in which to appropriately enhance this framework.

[The legal regulation of medical care in high-technology centers].

The article deals with the issues established during analysis of normative legal base regulating the activities in provision of high-technology medical care. The following positions are considered: the generation of public task to provide high-technology medical care, licensing and standardization; the issues of patients? Rights safeguard; the approaches to determine the types of high-technology medical services; the issues related to rendering paid services; the enhancement of organizational legal form of institutions rendering high-technology medical care. The recommendations on the development of the legislation in force are made.

[Medical innovations in the area of conflict between certification and allowance]. / Medizintechnische Innovationen im Spannungsfeld zwischen Zertifizierung und Vergütung.

The medical technology industry is one of the most innovative industries in Germany. Once a medical product is developed, it will be certificated according to European harmonized guidelines and norms. The respective national regulations in Germany are stipulated in the Medical Devices Act (MPG). Part of the certification process is a clinical assessment with the aim to prove that the medical device complies with the so-called essential requirements concerning safety, performance and suitability for the intended use as defined by the manufacturer. A clinical trial may be necessary to establish compliance with these requirements. During this clinical trial the devices are being assessed in patients according to strict requirements by law. The main criticism by the funding agencies is that these trials do not sufficiently apply methods of evidence-based medicine. Thereby they are not useful for assessing the medical benefit of the devices. The manufacturers' counter-argument is that the products are bearing the CE mark, that they comply with the uniform European standards and that their quality therefore has been appropriately assessed. This discussion relates to the question about payment for the products, as according to the Fifth Social Act the funding agencies are only permitted to finance products with a scientifically proven medical benefit. The present article discusses both positions in the context of national and international legislation for the certification of medical devices and presents possible solutions.

Patients' rights in a technology and market driven-Europe.

This article deals with the impact on patients' rights of medical and technological advances in a market oriented (European) society: what are the advantages and risks, what are the challenges that lay ahead of us? After introducing the subject matter, the first part deals with risks for patients' rights in the European cross border context (health care, direct to the public screening offers and biomedical research). The second part sketches some of the implications of innovation in health care and medical technology for patients' rights to autonomy and private life, particularly when third party interests are involved. The article ends with some suggestions on how best to protect patients' rights in the perspective of innovation in health care and medical research.

Assessing technological change in cardiothoracic surgery.

Technological innovation--broadly defined as the development and introduction of new drugs, devices, and procedures--has played a major role in advancing the field of cardiothoracic surgery. It has generated new forms of care for patients and improved treatment options. Innovation, however, comes at a price. Total national health care expenditures now exceed $2 trillion per year in the United States and all current estimates indicate that this number will continue to rise. As we continue to seek the most innovative medical treatments for cardiovascular disease, the spiraling cost of these technologies comes to the forefront. In this article, we address 3 challenges in managing the health and economic impact of new and emerging technologies in cardiothoracic surgery: (1) challenges associated with the dynamics of technological growth itself; (2) challenges associated with methods of analysis; and (3) the ways in which value judgments and political factors shape the translation of evidence into policy. We conclude by discussing changes in the analytical, financial, and institutional realms that can improve evidence-based decision-making in cardiac surgery.

Diffusion of medical technology: medical devices in India.

This review examines the diffusion of modern medical devices in India by analyzing trends in India's cross-border trade in medical devices, its domestic medical device production and utilization by households. We explore the implications of this process of diffusion for the efficacy, cost-effectiveness and equitable use of new medical devices in India, and review recent efforts to regulate the Indian medical device sector.

The influence of economic incentives and regulatory factors on the adoption of treatment technologies: a case study of technologies used to treat heart attacks.

The Technological Change in Health Care Research Network collected unique patient-level data on three procedures for treatment of heart attack patients (catheterization, coronary artery bypass grafts and percutaneous transluminal coronary angioplasty) for 17 countries over a 15-year period to examine the impact of economic and institutional factors on technology adoption. Specific institutional factors are shown to be important to the uptake of these technologies. Health-care systems characterized as public contract systems and reimbursement systems have higher adoption rates than public-integrated health-care systems. Central control of funding of investments is negatively associated with adoption rates and the impact is of the same magnitude as the overall health-care system classification. GDP per capita also has a strong role in initial adoption. The impact of income and institutional characteristics on the utilization rates of the three procedures diminishes over time.