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As medical care becomes'more advanced and complex, increasing importance is being attached to the im- plementation of team medical care that provides appropriate care while making use of the advances, mutually cooperating, and supplementing the high-level specializations of various branches of medicine in order to provide safe care with peace of mind. Planned team medical care is demanded in this era, and the Japanese Association of Medical Technologists is developing various projects as well as promoting the participation of biomedical laboratory scientists in team medical care. [Review].

In this article, the Author analyzes her own experience as a member of the IRB that approved a trial to determine the efficacy of a disobstruction procedure of extracranial veins by means of angioplasty in patients with multiple sclerosis (MS). The so-called "liberation therapy" was proposed by an Italian vascular surgeon, who theorized a condition called "chronic cerebrospinal venous insufficiency" (CCSVI) as playing a role in the pathogenesis of MS. This approval, given after an animated discussion amongst IRB members, lacked any solid scientific evidence of a causal relationship between CCSVI and MS, and was accepted despite the concerns about potential risks associated with the proposed therapy. Undoubtedly, considerable pressure was exerted on IRB by MS sufferers, who rushed off to get the surgery from the many clinics who offered liberation therapy.The remaining sense of bitter has raised a reflection on how to prevent similar future cases.

The publication of the 13 th January 2010 order makes the official accreditation necessary for all the laboratories of medical biology in France. This accreditation is delivered by a single official authority: the Cofrac. This accreditation is the acknowledgement of the ability of the laboratory to perform medico-technical acts corresponding to the scope of the accreditation. It must satisfy normative standards (Standard 15189), specific application documents of the Cofrac (SH REF 02), and legislative and regulatory rules in order to guarantee the reliability of the medical biology tests performed and the quality of the offered services in the sole interest of the patients. The accreditation is a long lasting process, which appears in a first step as very constraining. In the long term, it is experienced by the personnel as an acknowledgement of their quality and efficiency., (Copyright © 2013. Published by Elsevier SAS.)

As far as molecular biology is concerned, numerous are laboratories using in-house method. Used since many years, medical biologists have often a good practical knowledge about them. According to ISO 15189 accreditation, is this knowledge sufficient for the validation of these methods? We have asked this question ourselves about our in-house Leishmaniasis PCR.

The article considers the main positions concerning the clinical laboratory diagnostics as an independent clinical specialty and the principles of professional training and improvement of specialists. The basic issues complicating the training and improvement of personnel to be kept in line with actual needs of laboratory service of public health system are discussed. Among them are the availability of laboratory academic sub disciplines demanding a profound special theoretical education and technical skills; the need to account in the process of professional training the variety of forms, sizes and types of laboratory structures in different medical institutions; the need of special training programs for numerous specialists with non-medical basic education. The combination of the present system of postgraduate training of specialists on chairs of state educational organizations with initiative involvement of specialists in various public forms of permanent professional improvement (professional scientific societies meetings, research conferences, internet seminars, etc.) is supported Along with a positive appraisal of the existing system of training in the state educational institutions and corresponding regulation documents, a critique is expressed regarding certain actual documents which improperly limit the administrative functions of physicians of clinical laboratory diagnostics and complicate training of bacteriologists for clinical laboratories.

The medical biology laboratory accreditation according to the Iso 15189 standard, which main lines are mentioned in the article, is henceforth becoming a statutory obligation in France. All laboratories must apply, at least partly, to the COFRAC, by 31(st) October 2012. The EFS has largely anticipated the necessary steps to reach this objective and has developed an approach based on six basic processes. To date, 24 laboratories of various technical fields are accredited and several other submissions are pending. The Iso 15189 standard requirements match those already implemented at the EFS with the Certification. The trade standard operating procedures are almost included in the risk control management. Through the involvement of all the EFS members following precision action plans based on the sharing of successful experiences and the harmonization of trade practices, this compulsory objective will be reached and the deadline respected., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

In 2009, under the National Health Security Act 2007 (Cth), the Australian Government began introducing biosecurity regulations for laboratory research and other work involving certain pathogenic micro-organisms. The Security-Sensitive Biological Agents (SSBA) scheme is virtually unprecedented in Australia but is similar to the Biological Select Agents and Toxins (BSATs) scheme which has existed in the United States since the mid-1990s. This article examines recent United States experience in using domestic law as a national security tool to address the problem of biological weapons. The two lessons that emerge for Australia regarding biosecurity regulation are, first, that security threats can emanate from trusted laboratory personnel, even those with high-level security clearances; and secondly, governments need to manage the risk of imposing too great a regulatory burden. A reduction in potentially life-saving research, precipitated by scientists opting out of laboratory work, could undermine capacity to resist both natural infectious disease outbreaks and biological attacks.

The American Medical Association notes in its Principles of Medical Ethics that a physician "shall be dedicated to provide competent medical service with compassion and respect for human dignity." As physicians whose profession involves the medical direction of pathology and clinical laboratory services, pathologists strive to provide high-quality, cost-effective services to support the needs of patient care. These services must be provided under the aegis of extensive legal and regulatory mandates of various governmental and nongovernmental entities. To accomplish his/her task, the pathologist can use tools of evidence-based medicine and clinical practice guidelines together with his/her medical and scientific training and experience. At the same time, the Medical Director must be able to measure and demonstrate the value of his/her contribution in today's competitive environment.

The major purpose of this article is to emphasize the need for pharmaceutical scientists to have a better understanding of patent fundamentals. This need is illustrated by analyses of key scientific and legal issues that arose during recent patent infringement cases involving Prozac, Prilosec, and Buspar. Economic incentives for drug discovery and development clash with societal needs for low-cost pharmaceuticals in the United States and all over the world. The Hatch-Waxman Act of 1984 was enacted to promote public health by balancing the interests of brand name and generic companies. Patent protection, which provides a monopoly for a limited time, is aimed to provide such incentives. Creation of patents requires the interaction between scientists and lawyers, an endeavor made difficult by the differing intellectual spheres of their respective disciplines. Therefore, in the first place, a thorough understanding of patent fundamentals among pharmaceutical scientists will help them work more efficiently with patent attorneys. Second, it will enable them to appreciate the strengths and weaknesses of individual patents, which is critical in developing strategies amidst the ongoing patent tug-of-war between brand-name and generic companies.

This final rule revises and responds to comments on certain laboratory requirements issued pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100-578. Specifically, this final rule sets forth requirements for certain quality control (QC) provisions and personnel qualifications; consolidates and reorganizes the requirements for patient test management, QC, and quality assurance; and changes the consensus required for grading proficiency testing challenges. To ensure a smooth transition to the new provisions for directors of high complexity testing who are not board certified (but who have doctoral degrees), we will not be holding facilities out of compliance with the provisions of the rule concerning directors who are not board certified until the effective date of this new rule, to the extent the facilities are otherwise in compliance with the requirements for laboratory directors.

The freedom of movement of people and goods within the European Union (EU) has a large impact for the member states. Particularly within health care it is important to recognize, or if necessary obtain, an adequate level of the quality of profession and practice, so that citizens know that health care is offered in their country at a level comparable to other countries. The importance of recognition also applies to laboratory medicine. European Communities Confederation of Clinical Chemistry (EC4) is the organization of societies for clinical chemistry and laboratory medicine in the EU. In Europe, health care develops in the direction where patients are treated in a health care chain environment. In this chain, patients move quickly from primary health institutes to secondary and tertiary institutes, and vice versa. This situation involves many health care workers including several laboratories. Diagnosis and therapy are now 'core business' of health care. Medical laboratories play an essential role in this. The broad spectrum of medical laboratory investigations make consultancy of medical laboratory specialists ever more important. The quality of both professionals and laboratories, as well as continuity of laboratory data within and between laboratories, are of utmost importance.EC4 is active in giving support to attain such quality. In most countries, this is the case at present. EC4 plays a central role in the Coordination of Automatic Recognition of Equivalence of Standards (CARE), if such a level exists or is achieved. Such CARE is focussed at three levels, the profession, quality of laboratories and calibration of laboratory data. The EC4 Register of European Clinical Chemists is open for colleagues educated in (bio)chemistry, pharmacy, biology as well as medicine, and trained according to the EC4 Syllabus. Equivalence of standards has been granted to national training schemes of 13 European Union countries. Since its opening in 1998, the number of applicants is growing steadily and quickly, reaching 1225 in May 2001.EC4 has published essential criteria for quality systems of medical laboratories, which formed the basis for a ISO draft international standard regarding quality and competence of medical laboratories.EC4 stimulates projects like the Calibration 2000 project in the Netherlands which focus on continuity of laboratory data, within-as well as between-laboratories.

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department to revise quality control requirements and establish the qualification requirements necessary for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance.

Qualified personnel are necessary to ensure quality results, but there is no evidence on what minimal educational requirements are necessary. In the future, cost-effectiveness analysis may be useful for policy questions such as the utility of personnel regulations. CLIA '88 regulations require explicit assessment of personnel competency. Survey evidence suggests that previously regulated laboratories tend to have highly formalized competency assessment programs, while physician office laboratory programs are minimal. Responding laboratory supervisors had no uniform definition of competency, but technical abilities, productivity, and professionalism were regarded as essential. Suggestions for contemporary strategies by laboratory professionals and their organizations in the current increasingly competitive managed care environment are described. Faced with limited empirical evidence on personnel, laboratory directors and supervisors should focus on the total testing process, the needs of clinicians, and the uses of testing information to guide personnel assignments.

The Clinical Laboratory Improvement Amendments (CLIA 88) to the Clinical Laboratory Improvement Act of 1967 continues to undergo transformation since its implementation more than 2 years ago. The law and its subsequent regulatory modifications were intended to promote high quality in and accurate results from laboratory testing procedures, regardless of the site at which testing occurred. A number of federal regulatory agencies and committees such as the Healthcare Financing Administration, the Clinical Improved Amendments Committee, and the Commission on Laboratory Accreditation, as well as numerous new or modified regulations and requirements have gained importance since CLIA 88 was enacted. In this discussion, components of CLIA 88 that have the greatest impact on clinical microbiology laboratories are presented. In addition, the potential future significance of CLIA 88 are outlined.

In this rule we are responding to some of the comments on categorization of tests and personnel requirements received in response to rules published on February 28, 1992 and January 19, 1993. (In a future rule, we will be responding to the remaining comments.) We are revising our regulations to: Allow dentists and midlevel practitioners to perform tests in the "physician-performed" microscopy (PPM) subcategory of moderate complexity procedures (we now call the subcategory "provider-performed"); include three additional tests in PPM; and expand provisions relating to general supervisor and high complexity testing personnel.

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, which implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and announces our approval of a certifying organization for qualifying cytotechnologists. This rule extends the date by which an individual must enroll in an HCFA-approved cytology proficiency testing (PT) program and the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. In addition, we are extending the phase-in of the quality control requirements applicable to unmodified, moderate complexity tests cleared for commercial distribution by the Food and Drug Administration (FDA). We are extending the date to meet applicable CLIA QC requirements for laboratories using commercial, nonmodified tests to fulfill certain quality control (QC) requirements. These effective date extensions do not reduce the current requirements for quality test performance. The date extensions are necessary due to the limited number and scope of currently operating cytology PT programs, resource constraints that have prevented commencement of the substantial number of quality control reviews, and inability of many laboratory directors to complete certification requirements within the time period originally specified.

The reality of the world and the workplace is changing rapidly, and continuing the "old" ways will not provide the solutions needed to address the problems the health-care industry faces today. "The organization of the laboratory, as we now know it, will change. An environment in which every instrument is run by highly trained medical technologists is not likely to be the norm. Instead, laboratories will be staffed by lesser trained technicians under the direction of a limited number of medical technologists.... Licensing and regulatory trends for laboratories will support the downgrading of the average level of laboratory expertise required to perform tests". Similarly, in 1993 a regional director of the National Labor Relations Board (NLRB) ruled that many medical technologists do not meet the NLRB definition of professional because they perform highly automated and routine work that does not require the consistent exercise of discretion and judgment. Does the laboratory industry need to have all of its work done by highly trained medical technologists? A look at current laboratories would seem to answer that question as "no." On the other hand, do we need highly trained medical technologists in the laboratories? The answer is yes, but it is apparent that medical technologists of the future need to prepare themselves in new ways to address future demands on the profession.(ABSTRACT TRUNCATED AT 250 WORDS)

This article outlines the requirements of the Clinical Laboratory Improvement Amendments, as implemented by regulations that became effective in late 1992. Background information about the statute and a description of the laboratory director's role are provided, and proven strategies for meeting the regulations' quality assurance requirements are discussed in detail.

By now, physician groups that perform any laboratory testing should have either registered under the Clinical Laboratory Improvement Amendments (CLIA) or applied for a certificate of waiver. Rebecca Burke, in her article, discusses some of the risks associated with CLIA that group practices need to be aware of and how, in some cases, those risks can be reduced.

The law of defamation and the risks involved in issuing employment references are discussed. A hypothetical scenario is used to illustrate the legal standards governing the tort of defamation and to apply those standards to employment references. Practical suggestions for a "controlled reference" policy are provided, with the objective of allowing for responsible exchange of employment information and avoiding a defamation lawsuit.