External laboratory

Check that your external laboratories are accredited to ISO/IEC Guide 25 as a minimum. 

Once the raw clinical data have been imported into SAS, the next step is to transform those raw data into more useful analysis-ready data. Raw data here mean data that have been imported without manipulation into SAS from another data source. That data source is likely to be a clinical data management system, but it could also be external laboratory data, IVRS data, data found in Microsoft Office files, or CDISC model data serving as the raw data. These raw data as they exist are often not ready for analysis. There may be additional variables that need to be defined, and the data may not be structured in a way that is required for a particular SAS analysis procedure. So once the raw data have been brought into SAS, they usually require some kind of transformation into analysis-ready files, which this chapter will discuss. 

The terminology used in this Standard is slightly different from the others in that it is appropriate for the particular discipline. For example, the term, referral laboratories in paragraph 4.5 of ISO 15189 is used in a slightly different sense to the comparable clause in ISO/IEC 17025. Included in this section are consultants who may provide a second opinion. If the referral laboratory is an external laboratory, to which samples are submitted for a supplementary or confirmatory examination procedure and report, it is much the same as a contract laboratory in ISO/IEC 17025. There is an extra Annex in this Standard which covers the ethics applicable to laboratory medicine. 

The cost of appraisal in a laboratory is about measuring the laboratory performance, morritoring of the laboratory processes, doing internal quality control, internal and external laboratory audits and so on. 

In many cases of transport in solids, the atoms (ions) of one sublattice of the crystal are (almost) immobile. Here, we can identify the crystal lattice with the external (laboratory) frame and define the fluxes relative, to this immobile sublattice (to = 0). v° is bk-Xk (Eqn. (4.51)) where Xk is the sum of all local forces which can be applied externally (eg., an electric field), or which may stem from fields induced by the, (Fickian) diffusion process itself (eg., self-stresses). An example of such a diffusion process that leads to internal forces is the chemical interdiffusion of A-B. If the lattice parameter of the solid solution changes noticeably with concentration, an elastic stress field builds up and acts upon the diffusing particles, it depends not only on the concentration distribution, but on the geometry of the bounding crystal surfaces as well. 

In order to calculate this new steady state, one requires the / particle velocity, which vanishes in a reference system that is attached to the interface. In the external laboratory system the interface moves with constant velocity vb. A steady state is attained if the velocity of the i particles is equal to vb, that is,... 

External laboratory QC involves reference help from other laboratories and participation in national or international interlaboratory sample and data exchange programs such as Proficiency Testing (PT). Such programs may involve ... 

The particles are numbered from 1 to N with Mi the mass of particle i, R, = [A, Yt Zi) a column vector of Cartesian coordinates for particle i in the external, laboratory fixed, frame, Vr the Laplacian in the coordinates of R, and Ri — Rj the distance between particles i and j. The total Hamiltonian, eqn.(l), is, of course, separable into an operator describing the translational motion of the center of mass and an operator describing the internal energy. This separation is realized by a transformation to center-of-mass and internal (relative) coordinates. Let R be the vector of particle coordinates in the laboratory fixed reference frame. 

A Proficiency Test (PT) is defined as the study of laboratory performance by means of ongoing interlaboratory test comparisons . It is also known as an external quality assessment scheme, external laboratory performance check or external quality assurance (EQA). There are many such schemes run by independent external bodies for different analytes in a variety of matrices. Evidence in published papers shows that the performance of analytical laboratories improves as a result of participating in Proficiency Testing schemes and the betw een-laboratory precision can improve, sometimes dramatically. This is especially true in the early years of participation. 

Much of the collaboration during this period involved joint development of these new practices in both the academic and the industrial laboratories combined with relatively widespread dissemination, particularly through teaching and textbooks. The Standard Oil refinery in Baton Rouge, Louisiana, also played a key role as an unofficial external laboratory and employer of a great many of the graduates and a number of the faculty at MIT in the school of chemical engineering. 

We elaborate here on Eq. (6.1.6) consider a function F that pertains to a volume element dV which at time t is at position r and which moves with velocity v to a new position r -t- Ar at time t -t- At. Then take the total time derivative of F, DF/Dt, with respect to the moving center of mass of the volume element and compare this to dF/dt, taken with respect to the external laboratory axes. Given the position vectors x(t), y(t), z(t) we then find that... 

Quality control - independent department or external laboratory responsible for all aspects of quality control. Samples from each batch must be retained for one year, unless not practicable. 

Second 1 external laboratory 3 for RM10 isoproturon, chlorpyrifos 2 unsatisfactory datasets ( Z >3)... 

The type and sophistication of materials characterization instrumentation made available for a given IC facility will depend on several factorsi oost/benefit, quality perceptions, process complexity, maturity of the process. Commercial support labs are becoming more readily available to meet the VLSI challenge. The mix of in-house versus external laboratory support then becomes a matter of choice based on considerations of sample turn-around time, maintaining security of proprietary devices or processes, and outside versus inside expenditures. 

Rarely will a single adsorbent be optimal in all of these respects. Frequently it will be possible to narrow the choice to one or two classes of adsorbents, leaving a vast array of possible particle sizes, shapes, pretreatment conditions, and so forth. Final decisions should always be based on data. To make budget estimates, however, a number of different approaches can be derived from rules of thumb to provide quick experimental feasibility tests. Potential sources of such information are adsorbent or equipment vendors, published or commercial databases, and in-house or external laboratories. 

Some or all aspects of quality control may be carried out by a person not solely employed by the manufacturer. External laboratories should be adequately equipped, staffed and experienced to undertake the work contracted to them. 

Where samples are sent to external laboratories for occasional testing only, the purchase order or letter should specify the tests required, as specific a reference as possible to the test method and the designation of the samples despatched. The report of results should make reference to the method used. It may include a statement that a particular specification is or is not compiled with, but should not indicate approval or rejection. 

In certain justified cases the manufacture may have recourse to external laboratories for carrying out controls in conformity with the dossier of the medicine. Usually such cases are limited to controls requiring an expensive or rarely used installation or piece of equipment. 

Our laboratory has tested over 80 crude oil and condensate samples to date. Three external laboratories also tested some of the samples as part of a cooperative effort to develop standard procedures for handling and analysis. The laboratories used techniques other than combustion-CVAAS. Details of the outside labs testing statistics are not known. Table 5 shows a representative subset of these results for comparison. Each analysis by our laboratory was done three times and averaged. The same statistics apply as those discussed in the preceding paragraph. The critical value of 4.3 with 2 degrees of freedom from the Student s t distribution table [12] exaggerates the small differences that were actually observed between the three mercury determinations. 

Certification/assignment of values X based on a validated method and different methods used by external laboratories... 

It is necessary to add that for 333 samples or more, the complete laboratory is better than the current situation (external laboratory), but at this number of samples, the best option is the partial laboratory. In fact, from 0 to 202 samples the best option is the external laboratory, from 202 to 570 the partial laboratory, and from 570 samples, the best option is the fuU laboratory. 

High-tech laboratory 2 [9], In relation to the previous problem, the external laboratory, knowing that the biotech company is looking into the possibility of having its own laboratory facility, decides to lower the price of its analyses. The external laboratory does not believe that the biotech company would ever send out more than 250 samples for analysis per year, so the laboratory decides to lower its price to 475 per sample. Analyze and discuss the price set by the external laboratory. Is it sufficient to go down to 475 per sample ... 

A When the price per sample was 550, the external laboratory was better than the partial laboratory as long as the number of samples was less than 202. By lowering the price to 475, the external laboratory will be a good option as long as the number of samples is less than 263, and so it is a good move because the number of samples will not be more than 250. 

A pharmacy with adequate laboratory facilities will be able to perform analytical quality control tests in-house. In that case the necessary analytical instructions are part of the documentation system. In other cases it may be necessary for a pharmacy to outsource its analytical testing to an external laboratory. Then it is necessary to have a copy of the analytical instructions, including the key acceptance criteria. In this scenario it is paramount that a Service Level Agreement (SLA) or Technical Agreement is in place between the pharmacy and the laboratory (for SLA see Sect. 33.9.1). 

---