[Team Medical Care Involving Biomedical Laboratory Scientists].

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].

ABOUT PATIENTS, "INVENTORS", JOURNALISTS, SCIENTISTS AND IRBs (TO SAY NOTHING OF THE INSTITUTIONS): CCSVI AND MS.

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.

[In-house PCR practical knowledge: a sufficient validation according to NF EN ISO 15189?]. / Bilan d'utilisation d'une PCR « maison ¼ qualitative : une validation acceptable en regard de la norme NF EN ISO 15189 ?

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.

[Laboratory accreditation: a long and useful process]. / Les indispensables pratiques pour être accrédités Cofrac "l'accréditation pour les nuls".

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.

[The issues and basic principles of training of physicians of clinical laboratory diagnostics].

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.

[Medical biology accreditation at EFS]. / Accréditation des laboratoires de biologie médicale au sein de l'Établissement français du sang.

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.

Law in the time of anthrax: biosecurity lessons from the United States.

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 role of the medical laboratory director.

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.

Patent issues in drug development: perspectives of a pharmaceutical scientist-attorney.

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.

Medicare, Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications. Final rule.

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.