Other Laboratory Operations
Food and Drug Administration
The basics include those factors that are most familiar to Food and Drug Administration (FDA) analysts such as the chain of custody of samples, the analysis performed on the product including the results, and quality control procedures associated with the product or sample analysis. Since an FDA analyst represents the Agency and its enforcement efforts in court, every effort will be made to provide the proper training, guidance, and preparation prior to court room testimony.
The witness will have the opportunity to discuss testimony with the government attorney at a pre-trial conference. This is the time to ask questions and to ensure that the government attorney fully understands the analyst's testimony. Any unresolved concerns and issues, such as problems with sample integrity, should be settled by this stage. The witness's answers at trial should not be changed without the prior knowledge of government counsel.
The pre-trial conference is also the time to ask any logistical questions. Witnesses should ask the attorney whether they are expected to go directly to the courtroom or to another room while waiting to give testimony. Witnesses also need to know where they should go after testifying; should they remain in the courtroom or in the building, or are they free to leave?
Whether testifying as a fact witness or an expert witness (see part 8.4.1) analysts will be asked about their qualifications and professional history. Knowledge of a witness's schooling, experience, and professional achievements, including specialty certifications, training, and areas of expertise, may have a positive effect on the jury by lending credibility to responses. However, recounting every detail of one's professional life may bore the jury. The witness, therefore, should discuss with the attorney which accomplishments should be disclosed.
One of the first areas of testimony will involve the chain of custody. "Is the sample that was analyzed in the laboratory the same sample that the investigator picked up at the firm?" "Was the sample tampered with, or contaminated, at any point?" The analyst can testify only to that about which he or she has actual knowledge. Most likely the first contact with the sample occurred when it was picked up from the sample custodian. This may have been followed by completion of the sample accountability record, breaking the official seal(s), performing the analysis, resealing the sample, and returning it to the sample custodian. See ORA Laboratory Manual (LM) Volume II, Section 2, 5.7 Handling of Samples for a complete discussion of sample accountability. The analyst may be asked about the conditions under which the sample was stored while in the analyst's care. "Who, besides yourself, had access to the sample?" Remember the legal position of "presumption of regularity"; i.e. this is the way the employee always does his/her work.
188.8.131.52 The Tests
It is very important for the analyst who is to give scientific testimony understand the basic principles of the tests performed and the instruments used. The analyst may have performed the same analysis for twenty years, but if clear, concise, and confident answers cannot be given to basic questions the impression is that poor work has been done for the past twenty years. The fact that an analyst runs a gas chromatograph every day does not mean that he or she understands the basic theory and principles of operating the instrument.
The analyst avoids being coerced into detailed explanations of methods and equipment. Stating that the method or equipment is widely accepted for use by Federal and State laboratories can help to keep detailed descriptions to a minimum. If directed by the judge or counsel to provide details or additional explanation, the simplest, clearest answer should be given; for example, rather than providing an exhaustive account of the Association of Official Analytical Chemists (AOAC) collaborative process, stating that AOAC INTERNATIONAL methods are recognized as the official methods of analysis would suffice.
The jury is the audience. The use of jargon and scientific terms unfamiliar to jurors should be avoided. A jury that does not understand the terms used by a witness will not understand the message given in the testimony. The scientist is trained by experts in his or her chosen field, by reading professional journals, and through conversations with colleagues. Repeating lengthy conversations or communications, although meaningful to associates, may be difficult or impossible for the layman or non-scientist to understand. The scientific witness presents analytical findings so that all members of the jury, the judge, and the attorneys can easily grasp the significance of the testing and results. Technical expressions are clearly and carefully explained. A jury may know very little, if anything, about the laws of science, the accumulation of evidence, precautions taken to avoid error, and statistical interpretations.
The analyst should practice giving explanations of methodologies and techniques. The analyst may be very familiar with the procedures used but may have less experience explaining the procedures to those unfamiliar with the scientific principles involved. When possible, the analyst should describe the principles in understandable, everyday terms without being condescending. For example, capillary action by which a solvent migrates up a thin layer chromatography plate can be compared to the mechanism by which water travels up a dry paper towel.
184.108.40.206 The Method
The analyst is to understand the method used. Why was it chosen? How or why does it work? Responses such as, "Because my supervisor told me to," or "We always use that method," are not acceptable responses. The FDA policy has always been that, when in existence, official methods are used for sample analyses that are the basis for regulatory action. See LM Volume II, Section 2, Chapter 5.4 Test Methods and Validation for an explanation of Official Compendia and Analytical Manuals, respectively. The analyst may need to explain the meaning of a method's official status. Remember, use of official methodology does not relieve the analyst of the responsibility of proving method performance through quality controls, positive and negative controls, and recovery and reproducibility studies. Be prepared to explain why recoveries or certified reference materials were run; how they were run; and what they proved. Be prepared for questions concerning shortcomings of the methodology used and possible alternative methods that others may consider more reliable.
220.127.116.11 The Worksheet
One of the most important things the FDA analyst can do to ensure smooth testimony in court is to establish good analytical habits. Many analysts may hear senior coworkers state that they have been with the government for "X" number of years and have never been called to testify. Although this may be true, it is important to maintain credible, high quality science and documentation in the laboratory. Experience is not a substitute for good quality control. Before a case can proceed to trial, the veracity of the analytical findings is supported through the use of Quality Assurance/Quality Control (QA/QC) procedures. The analyst's worksheets will be subjected to many layers of review before they become introduced in a court of law. The analysis and documentation must be complete and meet agency standards of quality to survive the scientific and legal scrutiny in the courtroom.
Proper documentation will be the basis for much of the analyst's testimony. By the time a case gets to court many months, if not years, may have passed since the analysis was performed. It is very unlikely that the analyst would recall details about the case or details of the analysis.
Analysts must have knowledge of their local laboratory quality system. For example, if part of the analysis involved recording a critical temperature, the analyst is to document that the thermometer was checked for accuracy on a regular basis and the thermometer met the specifications before it was used in the analysis. This quality control applies to other instruments and equipment as well, and the local quality system should address the conditions for operation and specifications.
If the method used was not studied collaboratively or validated for the matrix in question, the analyst should be prepared to explain what types of validation were performed. Validation factors such as the use of method blanks, system suitability, certified reference material, and recoveries may be incorporated into the method. (See ORA Laboratory Manual (LM) Volume II, Section 2, 5.4.5, Methods, Method Verification and Validation.)