Laboratory evaluation program

Over the past decade, a major trend has been the development of the use of proficiency testing (PT) or evaluation materials (Fox 2000). PT materials are a type of reference material, which aid in assessment of analytical laboratory measurement quality. There will be an increased use of such materials as part of laboratory accreditation programs and other new quality assurance efforts, including internal audits. At the same time, a number of providers have used PT schemes to produce a form of RM intended to meet the ever-growing need for RMs required for routine QC use (Jenks 1995,1997). 

FDA device regulation is focused on the device and the device manufacturer. CLIA, on the other hand, focuses on laboratory quality, including the quality of the laboratory test results provided by the devices used, whether developed in-house or as a test kit in commercial distribution to multiple laboratories. The programs differ substantially in approaches and in data requirements. FDA requires unique submissions for each test under its purview, evaluates both performance and labeling, and requires demonstration of analytical validity and clinical validity as appropriate. CLIA inspects laboratories using a system approach based on key probes of the operating system. CLIA requires a demonstration of analytical performance and quality control but does not require a showing of either clinical validity or clinical utility. 

The NVLAP is comprised of a series of laboratory accreditation programs (LAPs), depending on what is requested and what is needed. Each LAP includes specific calibration and/or test standards and related methods and protocols assembled to satisfy the unique needs for accreditation in a field of testing or calibration. NVLAP accredits public and private laboratories based on evaluation of their technical qualifications and competence to carry out specific calibrations or tests. All are based on the ISO/IEC Guide 25 discussed in Section 2. The process involves an application and the payment of fees. This is followed by an on-site assessment. If deficiencies are found, these must be resolved to the satisfaction of the assessment team. The laboratory then participates in proficiency testing (Section 5.7) and a technical evaluation. 

Food and Drug Administration, Office of Planning and Evaluation. OPE Study 49 Results of the Toxicology Laboratory Inspection Program (Jan.-March 1979). July 1979. 

Both foreign and domestic establishments are covered by this program. Such coverage is intended to be consistent to the extent possible. This program provides guidance for establishment inspections and related investigations and for laboratory evaluations of methods of analysis proposed by applicants in NDA and ANDA submissions. 

More recently, proficiency evaluation programs have produced similar traceability linkages, but with a novel twist. The proficiency test material (transfer standard) is sent without attachment of results. The laboratory under test receives both an independent confirmation of measurement ability and, indirectly, a traceability linkage when the test is concluded and the assigned value of the measurand is disclosed. It is unlikely that proficiency evaluation will supplant traditional forms of providing traceability links. However, the concept does provide metrologists with an additional tool. 

The necessary components of a complete QA/QC program include internal QC criteria that demonstrate acceptable levels of performance, as determined by a QA review (audit). External review of data and procedures is accomplished by the monitoring activities of accreditation organizations such as the Standards Council of Canada (SCC, 2005). This includes laboratory evaluation samples (PT samples, see above) and a periodic (sometimes every 2 years) on-site assessment of all QA/ QC procedures, performed by external assessors from the accrediting organization. 

Although the program was primarily concerned with the synthesis and laboratory evaluation of these new propellant compositions, some practical confirmation of their theoretical performance was also desired. Consequently, a limited number of small motor firings were carried out. 

In the DDT exanple mentioned above, calculating the parameters associated with the 30% concentration in xylene and analyzing the effectiveness of octyl phenol adducts versus nonyl phenol adducts, we see the correlation between the predicted performance and the laboratory evaluations. Thus, a flow chart of events for the calculation, using a con juter program, would be as follows ... 

The results of this test for a con juter run using a program based on this model and laboratory evaluations are given below ... 

When appropriate, a dynamic (in-use) method evaluation of the assay will be performed following completion of the EMSL-LV single laboratory evaluation or confirmation. This type of evaluation is intended for immunoassays that are well-characterized and mature (i.e., a method where the developer has extensive performance data regarding matrix effects, cleanup, cross-reactivity, confirmatory analyses, and any other pertinent information). The data obtained during the dynamic evaluation will actually be used in a monitoring program. A dynamic evaluation can occur only where there is an immediate and urgent need for an analytical method. 

Liljegren, J.C., Dunn, W.E., DeVauU, G.E., and Policastro, A.J., Field measurement and model evaluation program for the assessment of the environmental effects of Military smokes field study of fog-oil smokes. Report Number AD-A205 344, Argonne National Laboratory, Argonne, IL, 1988. 

On the basis of this evidence, it is recommended that an experimental test program, consisting of both laboratory and field tests, be developed and Implemented to quantitatively measure the effects of acid deposition on both the as thetic and structural properties of PCC structures. It is, however, recommended that a preliminary series of controlled, accelerated laboratory tests be carried out before a full-scale field evaluation program is instituted. The objectives of the accelerated laboratory test program should be to identify the magnitude of the problem and to attempt to differentiate between the effects of wet deposition, dry deposition, and normal weathering. The preliminary test program should concentrate on surface chemistry effects and penetration rates of SO4, NOx, Cl as deposited from wet and dry deposition. The... 

This work was supported by the U. S. Nuclear Regulatory Commission as a part of the Qualllcation Testing Evaluation Program conducted by Sandia National Laboratories under contract DOE 40-550-70, NRC FIN No. A-1051. The authors are grateful to C. A. Quintana for technical support. 

Risk Reduction Engineering Laboratory., The superfiind innovation technology evaluation program Technology profiles fourth edition . EPA/540/5-91/008, November. (1991)... 

Establish an effective relationship with the California Fuel Cell Partnership (CaFCP) and define the value added tasks that the National Renewable Energy Laboratory (NREL) can provide to their fuel cell vehicle testing and evaluation program. 

Reddy and Maturi (2005) examined the feasibility of using electrokinetic remediation for the removal of mixed contaminants (i.e. mixtures of heavy metals and PAHs) from kaolin (low permeability soU). Likewise, different types of flushing solution were evaluated by a laboratory experimental program, including a cosolvent (n-butylamine), surfactants (3% Tween 80 and 5% Igepal CA-720), and a cyclodextrin (10% hydroxypropyl-j8-cyclodextrin or HPCD). It was reported that... 

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