Establishment of Need

As with laboratory testing in general, the decision to implement a POCT service requires (1) establishment of need, (2) consideration of the clinical, operational, and economic benefits, and (3) the costs involved.  

I BOX 12-4 Assessing the Need for a Point-of-Care Testing Service 

What clinical question is being asked when requesting this test What clinical decision is likely to be made upon receipt of the result  

What action is likely to be taken upon receipt of the result  

What outcome should be expected from the action taken  

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Establishment of needs-based criteria for evaluating candidate hardware, software, and process instruments. 

Establishment of Need and Development of Standards. Before standards can be developed, a need must be apparent to an institution, an individual, or to a professional society. This need can take many forms and can occur in several different contexts. At some point an individual, or a group of individuals, perhaps in a meeting, may realize that somebody ought to do something, and eventually action is initiated. 

Senior managers generally respond better to specific requests than to broad expressions of need. "First we need a mission statement" is likely to draw a quizzical expression and limited assistance. "The task group has developed this mission statement for your review and signature we plan to distribute it to all plant locations to kick off the effort" tells the boss exactly what you need and why you need it, and establishes that you expect to carry the ball. 

Asymmetric synthesis is a stimulating academic challenge, but since it has become clear that most chiral drugs can be administered safely only in the enantiomerically pure form, the industrial need for asymmetric methods has made research in asymmetric synthesis absolutely necessary [5]. This has driven a renaissance in the discipline of organic chemistry, because all of the old-established reactions need to be reinvestigated for their application in asymmetric synthesis [6]. This has also applied... 

To avoid homopolymer formation, it is necessary to ensure true molecular contact between the monomer and the polymer. Even if this is initially established, it needs to be maintained during the radiation treatment while the monomer is undergoing conversion. Several methods are used for minimizing the homopolymer formation. These include the addition of metal cations, such as Cu(II) and Fe(II). However, by this metal ion technique, both grafting and homopolymerization are suppressed to a great extent, thus permitting reasonable yield of graft with little homopolymer contamination by the proper selection of the optimum concentration of the inhibitor [83,90,91]. 

Test data should be planned by know ledgeable specialists in order to obtain the range, accuracy, and scope of needed data to achieve a pre-established mixing process result... 

Strigle [82] and Kister [93] point out the importance of evaluating data where available to reduce the need for interpolating the GPDC charts. The question of reasonably accurate ( 10 to 15%) flooding pressure drop data has been studied by Kister [93], and the results suggest that the establishment of flooding pressure drop curves... 

After a short introduction to the company and its products, the specification should describe in some detail the reasons why a new layout is needed. This will vary from the introduction of, or change to, new products, the establishment of a new factory or the need to explore the changing future demands on an existing site because of changing technology or market forces and opportunities. (Contracts are described in detail in Chapter 8.)... 

It has been proposed that a set of scheduled works may be assigned to local authorities. This class of works has been discussed in documents published by the Department of the Environment Air Quality Division and legislation came into force on 1 April 1991. It is proposed that these schedule (B) works will be licensed in much the same way as the existing scheduled works and that prior consent will be needed before operations of this type commence. This will give local authorities a much stronger hand in pollution abatement, and they will be able to avoid the establishment of premises in unsuitable areas or without adequate pollution-abatement equipment. At present, local authorities rely on planning conditions or nuisance provisions. 

Figure 13-4. Encigy level diagnim of a single-layer OLED, where the organic malerial is depicted as a fully depleted semiconductor. The valence band Ey corresponds to the HOMO and the conduction band Ec corresponds to the LUMO. Tile Fermi levels of the two metal electrodes are marked as Et-. Upon contact a built-in potential is established and needs to be compensated for, before the device will begin to operating.

A unique feature of the development of veterinary medicines for food-producing species is the need to consider the establishment of Maximum Residue Limits (M RLs) for the drug or its metabolites in food produce. A MRL is defined in the European Union as ... 

Over time, of course, such awareness has continued to grow, although so too has the realization that it should not be cost that drives macro or micro decision-making, but cost-effectiveness. That is, the health-care system needs to achieve a good balance between the resources it uses (the costs) and the outcomes it achieves (the effectiveness). More recent developments, such as the establishment of the National Institute for Clinical Excellence, make abundantly clear both the enduring relevance of economic considerations when deciding how to use health service resources and the pervasive need to balance economic with clinical (and related) objectives. 

Plant use is less biotechnologically advanced and fundamentally more complex. The first generation of plant metabolic engineering met with mixed success and produced unanticipated results — problems that are not necessarily restricted to manipulation of carotenogenesis. The reason is that predictive metabolic engineering relies on the establishment of both needed tools and an information infrastructure... 

The size distribution equations rest squarely on the validity of the principle of equal reactivity. Should they be proved appreciably in error in a given instance, this principle would have to be modified, or abandoned, for the polymerization process concerned. Since the principle seems well established, the likelihood of need for such qualifications seems remote. 

Finally some additional milestones in organization, research and development of RMs need to be mentioned. The large increase in the number of reference materials being produced led in 1975 to the formation of an ISO Council Committee on Reference Materials (ISO-REMCO) charged with the establishment of international guidelines on principles of certification, methods of use, needs, availability and nomenclature (Klich 1999), see also Sections 1.2 and 1.3. 

In this Chapter we highlight the practical considerations that must be understood by all users of RMs and CRMs we look at some of the issues of traceability and make the CRM user aware of the uncertainty budgets that need to be considered with the use of CRMs. No attempt will be made to advise CRM users on the proper use of statistics in the analytical measurement process and no statistical approaches on the establishment of measurement uncertainty will be given. There are a number of good texts on the subject which should be consulted. These are listed in the Further Reading section of the references at the end of this Chapter and include Miller and Miller (1993) and Taylor s work for NIST (Taylor 1985). 

Again for the titration of Ce(IV) with Fe(II) we shall now consider constant-potential amperometry at one Pt indicator electrode and do so on the basis of the voltammetric curves in Fig. 3.71. One can make a choice from three potentials eu e2 and e3, where the curves are virtually horizontal. Fig. 3.74 shows the current changes concerned during titration at e1 there is no deflection at all as it concerns Fe(III) and Fe(II) only at e2 and e3 there is a deflection at A = 1 but only to an extent determined by the ratio of the it values of the Ce and Fe redox couples. The establishment of the deflection point is easiest at e2 as it simply agrees with the intersection with the zero-current abscissa as being the equivalence point in fact, no deflection is needed in order to determine this intersection point, but if there is a deflection, the amperometric method is not useful compared with the non-faradaic potentiometric titration unless the concentration of analyte is too low. 

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