Laboratory Information Management responsibilities

When the analytical laboratory is not responsible for sampling, the quality management system often does not even take these weak links in the analytical process into account. Furthermore, if sample preparation (extraction, cleanup, etc.) has not been carried out carefully, even the most advanced, quality-controlled analytical instruments and sophisticated computer techniques cannot prevent the results of the analysis from being called into question. Finally, unless the interpretation and evaluation of results are underpinned by solid statistical data, the significance of these results is unclear, which in turn greatly undermines their merit. We therefore believe that quality control and quality assurance should involve all the steps of chemical analysis as an integral process, of which the validation of the analytical methods is merely one step, albeit an important one. In laboratory practice, quality criteria should address the rationality of the sampling plan, validation of methods, instruments and laboratory procedures, the reliability of identifications, the accuracy and precision of measured concentrations, and the comparability of laboratory results with relevant information produced earlier or elsewhere. 

SNL personnel are responsible for informing management before using a hazardous chemical in an application for which a potential exposure exists that has not previously been evaluated, as well as for conducting laboratory operations according to SNL s CHP. 

Each laboratory in the OPMBS was required to send a copy of each workbook and the associated raw data, to study management soon after completion of the analysis. This information was provided after internal technical review but before local quality assurance review. Study management used a team of experienced residue chemists to review the results and the raw data and to ensure that the information reported was fully supportable. The laboratory remained at all times responsible for the data reported, however, and the results of the external review were formally considered to be advisory. 

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use sirolimus. Manage patients receiving the drug in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information needed for the follow-up of the patient. Liver transplantation-excess mortality, graft loss, and hepatic artery thrombosis (HAT) The use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant recipients. Many of these patients had evidence of infection at or near the time of death. 

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe daclizumab. The physician responsible for daclizumab administration should have complete information requisite for the follow-up of the patient. Daclizumab should only be administered by health care personnel trained in the administration of the drug who have available adequate laboratory and supportive medical resources. 

The need to formulate a scientific conclusion from the data. Most contract laboratories conduct analyses and report the information to the client without providing interpretations of the data. In a GLP study, the study director is responsible for formulating the scientific conclusions from the data. The conclusions must be based solely on the data, taking into consideration the reliability of each data point. Management must support the efforts of the study director and... 

In research laboratories these difficulties are pan of the expected challenge. In industrial control laboratories they are serious distractions from obtaining information quickly, usually the D-value. There are several standard approaches to obtaining D-values from simple quantal response experiments using manageable numbers of replicates and without having to draw out survival curves on semilogarithmic paper. These methods assume exponential survival kinetics and should therefore be used with some caution if there is any doubt. 

The QAP should describe responses and corrective actions when laboratory performance levels are out of compliance. All samples identified in the report as processed by out-of-compliance procedures, systems, or analysts must be considered potentially deficient. Appropriate deficiency report forms need to be issued to inform the pertinent analysts, operators, supervisors, and managers. In some instances, a sample that does not meet general QA criteria nevertheless may be acceptable for the intended application, e.g., a measured value is well below the permissible level although its uncertainty exceeds specifications. 

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