Laboratory director

For acquisitions of instruments, cost-benefit analysis is usually only the first step. It is much more difficult to write a justification for an instrument based on project utilization. In some companies, it may be difficult to get an instrument unless one can go outside the company to get data to prove the benefits of an instrument. That scientific literature demonstrating the utility of an instrument on related compounds is not an acceptable substitute to data on the company s compound can be distressing it can be difficult to get the necessary permissions to take a sample out of the company to a university or to an instrumental applications laboratory, and it can be awkward to present data to a conference of senior managers who have little understanding of the science involved in the presentation. However, the present system often makes it incumbent on the laboratory director to do these things to get the instruments necessary to complete projects on time. 

Customer Service and Service Contracts It is important to choose a vendor that has a good customer service track record. Contact other laboratory directors and supervisors to ascertain their experience with the vendors that service their laboratories. Also, the cost of a service contract will need to be factored into the laboratory operating budget after the acquisition of an automated staining platform. 

GLP stands for good laboratory practices. These are federal regulations governing FDA- and EPA-affiliated laboratories and pertain to proper procedures in the laboratory to ensure that results are obtained in as trustworthy a manner as possible. SOP stands for standard operating procedure. These are step-by-step written procedures that are specially approved by laboratory directors for carrying out certain specific tasks. 

Once in Ludwigschafen the laboratory director, 0. Seidl, told me, Mark, you should go into business. If you are as successful in making money as you were in spending it on research we can already congratulate ourselves. 

Technical approaches must be scientifically valid and clinically relevant, and documentation that the laboratory director has reviewed all procedures on an annual basis is required. A copy of discontinued procedures is to be maintained for 2 yr thereafter, recording initial date of use and retirement date. 

An active program of surveillance of the quality of the immunostains produced must be defined. The primary elements of such a quality assurance (QA) program include procedures and policies for patient test management, quality control, proficiency testing, comparison of test results, relationship of clinical information to patient test results, personnel assessment, communications, complaint investigations, QA review with staff, and QA records. The documentation and review by the laboratory director of all QA procedures is imperative and cannot be overstressed. A brief explanation of each of the QA elements is as follows ... 

The laboratory should have written Standard Operating Procedures approved by the Laboratory Director that are intended to ensure the quality and integrity of the data generated by that laboratory. The Laboratory Director has the responsibility to approve revisions to standard operating procedures. The SOPs must be available to the persormel that are involved in the relevant activities as well as to the quality assurance team that performs the audit. 

A final report should be prepared after the completion of each laboratory activity. The final report should be signed and dated by the laboratory director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with the principles of good laboratory practice should be indicated. 

Upon completion of the analytic test component, a laboratory director can review original data that provides evidence that the assay procedure was run correctly. Customarily, interpreted results are issued under the signature of a clinical laboratory director. 

Another dilemma for the management of the anal5d ical laboratory is the estabhshment of a QA auditor who is separate from the study director. In smaller laboratories, the president or laboratory director may be the only individual with broad-based technical skills. This person would be defined as management, however, and as such, cannot act as a study director or QA auditor. The GLP advisories are very clear in establishing that even in a very small contract laboratory, the study director and QA auditor must be separate, with each reporting to management. 

Mr L.H. Eriksen, Feltman Research Laboratories Director, Picatinny Arsenal, has authorized approved this project. It is thru his interest, encouragement guidance that this publication is possible. The support of this project by Dr J.V.R. Kaufman, US Army Material Command Deputy Director for Plans, AMCRD, is also gratefully acknowledged. This Encyclopedia was prepared by scientists assigned to the Explosives Laboratory of FRL, Dr R.F. Walker, Chief. All reference works used, such as reports, periodicals, journal books, were made available thru the cooperation of the Scientific Technical Information Branch personnel,... 

Paolo Amat di San Filippo in a letter of June 25, 1975 addressed to the Feltman Research Laboratory Director, to be identical with Eptrile described by him and Dr Michele Giua (who died in 1966) in Annali di Chimica, Vol 50, 1381—88 (1960). This claim is not correct because Heptryl has the formula... 

The conventional approach is to extract from the TIC profile the mass spectra of all peaks above a predetermined intensity and to perform either manual or computer-assisted [39] identification of each mass spectrum. Analysis of mass spectra should be carried out only by properly trained technologists, under the supervision of a qualified laboratory director. Libraries of mass spectra should be available for identification of peaks that are not readily recognized. This library should be user-created, indexed by retention time and molecular weight, and have the capacity to be expanded and edited. 

In our laboratory, control values that fall within 2 standard deviations of the mean are considered acceptable and require no further action. Any control values that are either greater than 2 standard deviations or trends require review by a laboratory director. The laboratory director decides whether the analysis of the complete batch or of specific samples needs to be repeated and initiates troubleshooting. 

The laboratory director, typically a board-certified clinical biochemical geneticist, reviews all profiles and provides an interpretation based on pattern recognition and not simply on single abnormal values (Table 3.2.2). The laboratory director also determines the need for sample dilutions and carryover checks. 

Simple reporting of numeric results is not appropriate because most physicians are not familiar with pattern recognition. A comprehensive interpretation takes into consideration any available clinical and dietary information and other laboratory results, provides possible differential diagnoses, recommendations for additional biochemical testing and confirmatory studies if indicated, as well as contact information for the laboratory director in case the referring physician has additional questions. 

MURRAY S. COHEN (Chemistry) is Director of New Business Development at Apollo Chemical Corporation. He was formerly Technical Director for Borg Warner Chemicals and prior to that, Laboratory Director for Exxon Research and Development, Paramins Laboratory. 

Figure 1. Schematic of the mesomorphous structure in a lamellar phase. The different coordinate systems used in the text are outlined laboratory frame (L), director frame (D), and molecular frame (M). 0LD and 0DM are angles between the z axis in laboratory-director systems and director-molecular systems, respectively (13).

Richard M. Lelacheur, Laboratory Director, Taylor Technology, Inc., Princeton, NJ Cho-Ming Loi, Associate Research Fellow, Pfizer Global Research and Development, Department of Pharmacokinetics, Dynamics and Metabolism, San Diego, CA... 

DCLS is the analytical regulatory laboratory for the State of Virginia, and is staffed by nearly 350 employees analyzing over a million samples a year. The laboratory consists of a Quality Assurance Section and the Bureaus of Chemistry, Forensic Science, Microbiological Science, and Technical and Logistic Support. The QA program is based on a Division QA Policy mandated by the Laboratory Director, and a Division QA Plan which establishes broad guidelines for more specific Bureau QA Plans. Each Bureau is divided into diverse analytical sections which operate under even more individualized QA plans that are patterned after the Bureau Plan. 

While science writers today extoll the virtues of computer controlled laboratory instrumentation, knowledgeable lab dentists recognize the extent to which automated equipment can "free" the scientist from his laboratory investigations. A similar appraisal occurred in the crime laboratory. Crime laboratory directors soon recognized that no amount of modern equipment could reduce the ever-growing case load if there were not enough laboratory scientists to use the equipment. Adequately prepared laboratory scientists were needed to use the equipment to produce results which could be interpreted in a meaningful manner relative to the cases at hand. In other words, we have not as yet found the way to get the "computer" to testify under oath on the stand ... 

At the LEAA-sponsored FBI National Symposium on Crime Laboratory Development held in December, 1973, crime laboratory directors from around the country selected several priority research areas. The Institute has been able to respond to most of the high priority areas in the form of new grants addressing blood, semen and hair characterization. 

Department of Chemistry North Western University 2145 Sheridan Road Evanston, Illinois 60208-3113, USA E-mail ibers chem.nwu.edu Prof. Thomas J. Meyer Associate Laboratory Director for Strategic and Supporting Research Los Alamos National Laboratory PO Box 1663 Mail Stop A 127 Los Alamos, NM 87545, USA E-mail tjmeyer lanl.gov Prof. Fred Wudl Department of Chemistry University of California Los Angeles, CA 90024-1569, USA E-mail wudl chem.ucla.edu... 

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