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Operational Procedures (operational + procedure)
Selected AbstractsIdentification of Acipenseriformes species in tradeJOURNAL OF APPLIED ICHTHYOLOGY, Issue 2008A. Ludwig Summary Sturgeons and paddlefishes (Acipenseridae) are highly endangered freshwater fishes. Their eggs (sold as caviar) are one of the most valuable wildlife products in international trade. Concerns of overharvesting and the conservation status of many of the 27 extant species of Acipenseriformes led to all species being included on the CITES Appendices in 1998. Since then international trade in all products and parts from sturgeon and paddlefish has been regulated. However, despite the controls on trade, unsustainable harvesting continues to threaten many populations. Illegal fishing and trade continues to be a threat to the management of these fish. To enforce the regulation of legal trade and prevention of illegal trade, the development of a uniform identification system for parts and derivates of Acipenseriformes has been identified as an urgent requirement. Ideally this system should be suitable for (i) identification at the species-level of caviar and other products from Acipenseriformes; (ii) population identification; (iii) source identification (wild vs aquaculture); and (iv) determining the age of caviar because strict timeframes govern its international trade. This paper reviews the techniques currently available and their potential to be used in an identification system for Acipenseriformes species and their products in trade. A review of all available identification techniques has shown that there is not a single method that can meet all requirements (see i,iv), and it does not appear to be feasible to develop such a method in the near future therefore the most appropriate methods need to be developed for each. Considering the advantages and disadvantages of all techniques reviewed in this document, the following conclusions can be drawn: (i) for the identification of species, approaches are recommended that target mitochondrial cytochrome b sequences (RFLP, nested PCR or direct sequencing). However, they show limitations for the detection of hybrids (although natural hybrids are rare, the number of artificially produced hybrids in aquaculture is increasing) and for the differentiation of the following closely related species complexes: Acipenser gueldenstaedti,Acipenser baerii,Acipenser persicus,Acipenser naccarii; Acipenser medirostris,Acipenser mikadoi; and Scaphirhynchus albus,Scaphirhynchus plathorhynchus,Scaphirhynchus suttkusi; (ii) the identification of different populations of the same species is currently not feasible because genetic data are incomplete for most populations, and stocking and release programmes, which have become more and more common, often result in a mixture of phenotypes and genotypes, thereby impeding the creation and application of such a population identification system; (iii) source identification based on genetic approaches can be excluded at present because there are no genetic differences between wild and hatchery-raised fish. This is the result of the continuing restocking of natural populations with captive fish and vice versa. However, because rearing (i.e. environmental) conditions are different, methods focusing on differences in water quality or food seem to be more appropriate (for example differences in fatty acid composition). So far, very few studies have been conducted and therefore, source identification methods merit further exploration; and (iv) the age of a product in trade cannot be detected by DNA-based methods and protein profiling is undoubtedly impractical due to hard-to-perform, labour-and cost-intensive methods, which are highly susceptible to protein degradation. Arising from the limits discussed above, the next steps in the development of a uniform sturgeon identification system are proposed to be the following: (i) designation of qualified reference laboratories at national levels in (re-) exporting and importing countries. These should be approved through a standardized testing procedure, for instance a ring test on blind samples. Registered laboratories should be published and disseminated and their accreditations should be subject to certain guarantees regarding quality, economic independence and scientific rigour. Operational procedures have to be determined and standardized among reference laboratories; (ii) establishment of reference collections that are accessible to the reference laboratories containing DNA analyses results and information on the location and availability of tissue samples. This is highly recommended as an important step towards a population identification system and indispensable for a general species identification system; (iii) creation of a website access to the reference collections containing the reference database information about genetic samples, comparable to NCBI, which provides background data: sample location; population information; citation; available genetic data; location of archival storage; currently treated and distributed caviar and status of analysis. This website should also be a forum for the exchange of knowledge on and experiences with identification systems, species and population status information, relevant scientific research, etc.; and (iv) the outcome of the trade identification tests should be made available to the reference laboratories for future reference. The universal caviar labelling system could incorporate an indication of the verification of the consignment. In view of the lack of knowledge and the great need to develop a uniform identification system for Acipenseriformes with regard to the importance of the international caviar trade, further scientific guidance and appropriate research is strongly recommended. Progress should be assessed and exchanged on a regular basis. [source] Inter-expert agreement of seven criteria in causality assessment of adverse drug reactionsBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 4 2007Yannick Arimone What is already known about this subject ,,In pharmacovigilance, many methods have been proposed for causality assessment of adverse drug reactions. ,,Expert judgement is commonly used to evaluate the causal relationship between a drug treatment and the occurrence of an adverse event. This form of judgement relies either explicitly or implicitly on causality criteria. What this study adds ,,Our study compares the judgements of five senior experts using global introspection about drug causation and seven causality criteria on a random set of putative adverse drug reactions. ,,Even if previous publications have shown poor agreement between experts using global introspection, few have compared judgements of well trained pharmacologists, familiar with using a standardized causality assessment method. Aims To evaluate agreement between five senior experts when assessing seven causality criteria and the probability of drug causation. Methods A sample of 31 adverse event-drug pairs was constituted. For each pair, five experts separately assessed (i) the probability of drug causation, which was secondarily divided into seven causality levels: ruled out (0,0.05), unlikely (0.06,0.25), doubtful (0.26,0.45), indeterminate (0.46,0.55), plausible (0.56,0.75), likely (0.76,0.95), and certain (0.96,1); and (ii) seven causality criteria. To test discrepancies between experts, the kappa index was used. Results The agreement of the five experts was very poor (kappa = 0.05) for the probability of drug causation. Among the seven levels of causality, only ,doubtful' showed a significant rate of agreement (kappa = 0.32, P < 0.001). For all criteria, the kappa index was significant except for the item ,risk(s) factor(s)' (kappa = 0.09). Agreement between experts was good (0.64, P < 0.001) only for the criterion ,reaction at site of application or toxic plasma concentration of the drug or validated test'. However, the rate of agreement with kappa indices of the causality criteria ranged from 0.12 to 0.38. Conclusions This study confirms that in the absence of an operational procedure, agreement between experts is low. This should be considered when designing a causality assessment method. In particular, criteria inducing a low level of agreement should have their weight reduced. [source] Audit of local performance compared with standards recommended by the national guidelines for aetiologic investigation of permanent childhood hearing impairmentCHILD: CARE, HEALTH AND DEVELOPMENT, Issue 6 2005S. Yoong Abstract Background National guidelines for aetiologic investigation of childhood deafness were developed as the Newborn Hearing Screening Program (NHSP) was being implemented in the United Kingdom. This guidance document was expected to be incorporated into the operational procedure of the NHSP. Method This criterion-based audit compared local care set against developed guidelines that can be used to assess the appropriateness of specific investigations, services and outcomes. Data on children diagnosed to have sensorineural deafness from March 2002,2004 were extracted from an established computerized database for analysis. Results Forty-seven children were included; 17 have bilateral severe to profound hearing loss, 25 have bilateral mild to moderate loss and 5 with unilateral loss. A high proportion of Pakistani children were from consanguineous marriages with a family history of deafness. Total 29.8% of children were diagnosed through newborn screening and 70.2% detected through hearing surveillance programmes. For children with bilateral severe to profound deafness, 53.0% accepted, 5.9% declined and 41.2% were not offered imaging of their inner ears. A total of 47.1% accepted and 52.9% declined electrocardiograph (ECG) evaluation. Total 70.6% accepted and 29.4% declined connexin mutations testing. Parental requests were required for those with lesser degree of hearing loss. Total 24% accepted, 28% declined and 48% were not offered connexin testing. None were offered ECG and imaging. Testing for congenital infections was inappropriate for children over 1 year old. Ten subjects accepted and five declined this investigation. In the total group, 63.8% accepted, 17.0% declined and 19.1% were not offered referral to the ophthalmic service. Total 46.8% accepted, 44.7% declined and 8.5% were not offered referral to genetics service. Investigations resulted in two connexin-positive children with moderate loss. Conclusion Our study identified key areas where guidelines were not followed. These were related to lack of funding and parental choice. This sample has a higher connexin ,hit' rate for lesser degree deafness. [source] Optimization and Control of Industrial Microbial Cultivation ProcessesENGINEERING IN LIFE SCIENCES (ELECTRONIC), Issue 2 2006M. Jenzsch Abstract Compared to the immense achievements in fundamental molecular biological sciences, the improvements in the fermentation and downstream processing technologies used in industry have been less spectacular over the last decade. Hence, there is a misbalance between new cellular systems and production technologies, resulting in a decreasing annual rate of approved production processes. In its PAT initiative the U.S. Food and Drug Administration identifies the potential for continuous improvement and makes concrete suggestions how this can be achieved. Here, some of these suggestions were applied to recombinant protein production with Escherichia coli and Pichia pastoris cultures. Concretely, the development of process operational procedures is discussed that allow a more tight supervision of the processes and the automatic control in cases where processes deviate from their set-point profiles. [source] Factors influencing densities of non-indigenous species in the ballast water of ships arriving at ports in Puget Sound, Washington, United StatesAQUATIC CONSERVATION: MARINE AND FRESHWATER ECOSYSTEMS, Issue 3 2009Jeffery R. Cordell Abstract 1.Oceanographic characteristics and the presence of international shipping in Puget Sound, Washington, USA contribute to its vulnerability to non-indigenous species (NIS) invasions. To evaluate NIS arriving in ballast water, zooplankton was sampled in 380 ballast tanks of ships after they entered Puget Sound. 2.Taxa were classified into a higher risk group of coastal organisms (including known NIS), and a lower risk group of largely oceanic species. Most ships reported conducting mid-ocean ballast water exchange (BWE). However, despite state regulations requiring BWE, and apparent compliance by ship operators, most sampled tanks from both transpacific and coastal routes had coastal zooplankton densities exceeding internationally proposed discharge standards. 3.BWE efficiency models and controlled before-and-after BWE experiments indicate that BWE consistently removes most coastal zooplankton. However, this study found that although the empty,refill method of BWE significantly reduced coastal plankton compared with un-exchanged tanks, the flow-through method did not, and in either case remaining coastal plankton densities presented appreciable risks of introducing NIS. 4.Densities of high risk taxa were consistently and significantly higher from US domestic trips dominated by tank ships carrying ballast water from California, and lower in samples from trans-Pacific trips dominated by container ships and bulk carriers with ballast from Asia. These findings are probably a result of the dense and diverse NIS assemblages present in California and other US west coast estuaries and the comparatively short transit times between them and Puget Sound. 5.While it appears that BWE can effectively replace NIS with less risky ocean species, new reporting, verification, and operational procedures may be necessary to enhance BWE efficacy. In the long-term, the introduction of ballast water treatment technologies may be required to significantly reduce the discharge of risky organisms from commercial ships if BWE practices do not become more effective. Copyright © 2008 John Wiley & Sons, Ltd. [source] The Financial Performance of Low-Cost and Full-Service Airlines in Times of CrisisCANADIAN JOURNAL OF ADMINISTRATIVE SCIENCES, Issue 1 2005Triant Flouris This paper examines the stock and accounting performance of three major airlines in the United States in the aftermath of the September 11, 2001, terrorist attacks. September 11 (9/11) resulted in dramatic changes in the airline industry and had significant implications for the economic gains and future prospects of most airlines. Our study focuses on the stock market's perception of the viability of low-cost versus full-service business models in the aftermath of 9/11. We choose Southwest Airlines as a typical low-cost airline and compare its accounting and stock performance to two full-service airlines, Continental and Northwest. We find that Southwest's performance was highly superior to that of Continental and Northwest and argue that Southwest's business model, in the eyes of investors, provides the firm with significantly more financial and operational flexibility than full-service airlines. Southwest's lower operating costs, consumer trust, product offering, corporate structure, workforce and work practices, as well as operational procedures are all factors that appear to contribute to Southwest's relative success. Résumé Cet article étudie la performance boursière et comptable de trois grands transporteurs aériens opérant aux États-Unis au lendemain des attentats du 11 septembre 2001. Ces événements ont entraîné des changements radicaux dans l'industrie du transport aérien et ont eu des répercussions considérables sur les gains économiques de la plupart des compagnies aériennes. Notre étude compare la viabilité des modèles d'entreprise à bas prix à celle des modèles traditionnels, au lendemain de l'attaque terroriste. Nous avons choisi Southwest Airlines comme l'exemple type de transporteur aérien pratiquant des bas prix et nous comparons sa comptabilité et le rendement de son action à ceux de deux transporteurs aériens à service complet, notamment Continental et Northwest. Nous constatons que le rendement de Southwest est de loin supérieur à celui de Continental et de Northwest. Nous montrons que, d'après les investisseurs, le modèle de gestion de Southwest lui donne beaucoup plus de flexibilité financière et opérationnelle que le modèle de gestion pratiqué par les transporteurs aériens traditionnels. La faiblesse de ses charges d'exploitation, la confiance des consommateurs, son offre de produits, sa structure d'organisation, son effectif, ses pratiques de travail, ainsi que ses méthodes opérationnelles sont autant d'éléments qui semblent contribuer au succès relatif de Southwest. [source] | ||||||||||