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Evolving delivery systems for clinical laboratories: the Albany Medical Center Regional Laboratory Network.

The Albany Medical Center is a not-for-profit institution consisting of the Albany Medical College and the Albany Medical Center Hospital. Before 1989, the college's pathology department was not affiliated with the clinical laboratories of the hospital and no regional laboratory program existed. Subsequent to 1989, with the recruitment of a new chairman of the department of pathology, the department and the clinical laboratories of the hospital merged to create the Department of Pathology and laboratory Medicine. The strategic plan for the redesign included goals to respond to new opportunities and seek new contracts in the community, to enhance the efficiency within the clinical laboratories, and to increase the volume of anatomic pathology specimens. The newly formed department decided to explore the opportunities to work with hospitals, physician groups, and insurers in the area to create a regional laboratory network. This article describes how changes were implemented, including some of the problems that were encountered. An assessment of the result evaluates the success of the network and discusses its future direction.

Academic Medical Centers↗

[Distribution of financial resources according to the productivity (determined by bibliometry) in the Medical Research Laboratories of the Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo (Brazil)].

A challenge that research managers have to face is how to "reallocate" agency budgets in order to bring them in line with the results of performance reviews. Research policies must develop a strategic plan describing their goals, devise yardsticks to measure their progress, and tie that performance to allocate research funds with some degree of priority. Though Brazil already has a substantial presence in world's science, scientific enterprise must be used to strengthen it. The first step should be to raise standards in Brazilian science by concentrating the resources on supporting excellence. A strategy to judge biomedical research productivity should include tactics to disclose whether the resulting publications have appeared in the field's most respected, peer-reviewed journals. A pilot project to road-test the above-discussed ideas on performance measurements was conducted at the Laboratories of Medical Research (Clinical Hospital, University of São Paulo School of Medicine). These Laboratories perform a vast proportion of biomedical research at the country's largest University. This article illustrates that confidence in fairness and consistency with which funds are now being allocated has helped to improve productivity, thus showing that this strategy is fruitful.

Bibliometrics↗

Implementation of biosurety systems in a Department of Defense medical research laboratory.

New biosurety regulations and guidelines were implemented in 2003 because of increased concern for the safety and security of biological select agents and toxins (BSAT) that may be used as weapons of mass destruction. Biosurety is defined as the combination of security, biosafety, agent accountability, and personnel reliability needed to prevent unauthorized access to select agents of bioterrorism. These new regulations will lead to increased scrutiny of the use of select biological agents in registered research laboratories, but the regulations may have unintended effects on cost, progress, and perceptions in programs previously considered part of the academic research community. We review the history of biosurety, evolving guidelines, implementation of the regulations, and impacts at the lead research laboratory for medical biological defense for the Department of Defense.

Bioterrorism↗

A simulation laboratory for medical education.

Simulation as an instructional technique is being utilized for the learning of clinical skills in the training of health professionals. The Center for Educational Development at the University of Illinois College of Medicine has established a Learning Resource and Development Center to assist medical faculty in the development and evaluation of instructional simulations. These are not designed to replace clinical experiences but to provide additional opportunities for students to strengthen skills in patient examination. Prior to the introduction of these learning tools in 1972, a study was undertaken to validate their instructional effectiveness. After an additional two years of operation and experimentation, a revalidation study was undertaken during the fall of 1974. Improvements are continually being made in the various simulation formats as a result of feedback from students and faculty.

Chicago↗

[Future guidelines for medical technologists].

In this symposium, ways in which medical technologists can contribute as supporting members in Japan's health care system will be discussed. Improvement in the job specifications of health care professionals has been identified as a major pillar of Japanese health care reform. As members of the medical support team, along with university professors and medical laboratory researchers, medical technologists will be expected to improve their knowledge and skill. Medical technologists should therefore be prepared to make great efforts to progress according to expectations, and these things must be kept in mind as a future guideline for medical technologists in Japan.

Delivery of Health Care↗

[Fundamentals of quality control systems in medical-biochemical laboratories--the role of marketing].

The basic criterion for the overall quality system in medical biochemistry laboratories concerning equipment, premises and laboratory staff in primary health care (PHC) (Regulations on quality systems and good laboratory practice of the Croatian Medical Biochemists Chamber, 1995, Regulations on categorization of medical biochemistry laboratories of the Croatian Medical Biochemists Chamber, 1996, EC4: Essential criteria for quality systems in medical laboratories. Eur J Clin Chem Clin Biochem 1997 in medical biochemical laboratories included in the First Croatia health project, Primary health care subproject, has been met by the marketing approach to the project. The equipment ensuring implementation of the complete laboratory program (NN/96), more accurate and precise analytical procedures, and higher reliability of laboratory test results compared with previous equipment, has been purchased by an international tender. Uniform technology and methods of analysis have ensured high standards of good laboratory services, yielding test results than can be transferred from primary to secondary health care level. The new equipment has improved organization between central and detached medical biochemistry laboratory units, while the high quality requirement has led to improvement in the staff structure, e.g., medical biochemists have been employed in laboratories that had previously worked without such a professional. Equipment renewal has been accompanied by proper education for all levels of PHC professionals.

Chemistry, Clinical↗

[Metrological problems of laboratory diagnosis].

Medical laboratory diagnosis is progressing from one analysis to a group of analysis with rather intricate statistical processing of data via multidimensional analysis, at the same time it is necessary to define a patient's individual normal levels, i.e. a "health certificate". In this regard, the process may be achieved when complex analyzers, which have a reliable metrological support, and systems for collection of both clinical and laboratory information and its simultaneous analysis are put into laboratories' practical work.

Clinical Laboratory Techniques↗

[The 25-year-old Department of Medical Parasitology and the 10-year-old Reference Laboratory for Medical Arachno-entomology of East Germany at the Leipzig District Sanitary Inspection Service and District Institute].

Review of the most important contributions of the-25-year-old Department of Medical Parasitology and of the ten-year-old Reference Laboratory for Medical Arachno-Entomology at the Sanitary Inspection and Institute, District of Leipzig, as an example for the performance of hygienic zoology in the German Democratic Republic.

Animals↗

Validation of assembled nucleic acid-based tests in diagnostic microbiology laboratories.

Medical microbiology and virology laboratories use nucleic acid tests (NAT) to detect genomic material of infectious organisms in clinical samples. Laboratories choose to perform assembled (or in-house) NAT if commercial assays are not available or if assembled NAT are more economical or accurate. One reason commercial assays are more expensive is because extensive validation is necessary before the kit is marketed, as manufacturers must accept liability for the performance of their assays, assuming their instructions are followed. On the other hand, it is a particular laboratory's responsibility to validate an assembled NAT prior to using it for testing and reporting results on human samples. There are few published guidelines for the validation of assembled NAT. One procedure that laboratories can use to establish a validation process for an assay is detailed in this document. Before validating a method, laboratories must optimise it and then document the protocol. All instruments must be calibrated and maintained throughout the testing process. The validation process involves a series of steps including: (i) testing of dilution series of positive samples to determine the limits of detection of the assay and their linearity over concentrations to be measured in quantitative NAT; (ii) establishing the day-to-day variation of the assay's performance; (iii) evaluating the sensitivity and specificity of the assay as far as practicable, along with the extent of cross-reactivity with other genomic material; and (iv) assuring the quality of assembled assays using quality control procedures that monitor the performance of reagent batches before introducing new lots of reagent for testing.

DNA, Bacterial↗

Tracing our roots: years of turmoil (1962-1977).

OBJECTIVE: To describe the activities of the American Society of Clinical Pathologists and the sequence of events leading to the establishment of the National Accrediting Agency for Clinical Laboratory Science and Medical Laboratory Personnel. DESIGN: A survey of literature on the history of clinical laboratory science was conducted. References consulted various books and professional journals. CONCLUSIONS: By virtue of its close association with ASCP, ASMT became drawn into a series of legal actions between 1962 and 1977. Although ASMT was eventually dropped from all law-suits, the association's leadership recognized the need for greater autonomy and independence from ASCP. Clinical laboratory science achieved several victories during this period with respect to certification and mandatory re-registration by the BOR. Responsibility for accreditation of educational programs was shifted from the BOS to NAACLS and the establishment of the National Certification Agency for Medical Laboratory Personnel signified ASMT's commitment to certification by the profession for the profession.

Accreditation↗

[Consulting work performed by the hospital laboratory: the usefulness of the laboratory information office in Tenri Hospital].

We introduced a consultation process to the clinical laboratory in our hospital. The laboratory information room has been installed for three years in the hospital, and all questions concerning the laboratory tests are received. A clinical laboratory physician and an experienced medical laboratory technician address any complex or technical questions. The clinical laboratory physician is necessary in the laboratory information room because of his or her knowledge of the clinical tests based on clinical experience, and his or her knowledge of the aspects of epidemiology and laboratory management. Clinical experience is especially necessary to communicate between doctors and nurses and medical laboratory technicians. Because managing the business of the laboratory information room by a clinical laboratory physician alone is unrealistic for a lot of hospitals, most laboratory information room must have several medical laboratory technicians and a few clinical laboratory physicians to cooperate with them and help their work.

Japan↗