SOFT / AAFS Forensic Laboratory Guidelines – 20061.SOFT / AAFSFORENSIC TOXICOLOGYLABORATORY GUIDELINES2006 VERSION1.INTRODUCTIONThe Forensic Toxicology Laboratory Guidelines were originally published in 1991 as two maindocuments (Guidelines plus Appendix), plus the self-evaluation checklist. The primarydocument, the Guidelines, was initially drafted in response to the growth and regulation offorensic urine drug testing. It was an attempt to take the important issues that were addressed forFederal Workplace Drug Testing Programs and draft them into terms which could be morerealistically applied to the areas of Post-Mortem Forensic Toxicology and Human-PerformanceForensic Toxicology. However, the Guidelines Committee agreed that there were manyadditional issues which were important to cover, but which might better belong in asupplementary document - the Appendix to the Guidelines. Since 1991, the profession hasmatured in many ways. In 1996 the American Board of Forensic Toxicology launched aForensic Toxicology Accreditation program based primarily on the SOFT/AAFS Guidelines andAppendix. In 1997 New York State passed legislation requiring the accreditation of all forensiclaboratories in the public sector, and others may follow. The Guidelines Committee concludedthat it was time to redraft the original Guidelines and Appendix into a single cohesive documentwhich would be easier to reference and to update in the future. That was done, and the finaldocument approved and adopted. Subsequent changes to the format and content were made andapproved in 1998, 2000, 2002 and 2006.Introduction from 1991 GuidelinesIn response to the Guidelines for Federal Workplace Drug Testing Programs issued by the U. S.Department of Health and Human Services in 1987, the Society of Forensic Toxicologists andthe Toxicology Section of the American Academy of Forensic Sciences appointed a jointcommittee of members to recommend a supplementary set of guidelines for the practice offorensic toxicology. The federal guidelines, especially with respect to laboratory personnel andoperating procedures, may not always be appropriate for other types of forensic toxicology, andthe guidelines set forth below represent recommendations of the Society/Academy committee inresponse to that issue. These suggestions do not necessarily reflect opinions about the minimumrequirement for any laboratory, and have no regulatory purpose; rather, they are intended toassist laboratories engaged in the practice of forensic toxicology in achieving future goals.
SOFT / AAFS Forensic Laboratory Guidelines – 20062.2.SCOPEThe original committee concluded that specific guidelines for the practice of forensic toxicologywould be appropriate for two defined areas: Post-Mortem Forensic Toxicology and HumanPerformance Forensic Toxicology.The committee concluded that it was not appropriate to include Forensic Urine Drug Testing,because that area of practice has been covered by the Department of Health and Human ServicesGuidelines and by the College of American Pathologists Accreditation program.The specific aims of the committee, with respect to postmortem and human-performanceforensic toxicology, were to provide detailed guidelines for laboratory practices and to prepare achecklist for self-evaluation that may also serve as an important component of a programdesigned to prepare a laboratory for accreditation. The self-evaluation checklist has since beendropped after it was adopted and expanded by the American Board of Forensic Toxicology aspart of their laboratory accreditation program in 1996.3.DEFINITIONSPost-Mortem Forensic Toxicology - determines the absence or presence of drugs and theirmetabolites, chemicals such as ethanol and other volatile substances, carbon monoxide and othergases, metals, and other toxic chemicals in human fluids and tissues, and evaluates their role as adeterminant or contributory factor in the cause and manner of death;Human-Performance Forensic Toxicology - determines the absence or presence of ethanol andother drugs and chemicals in blood, breath or other appropriate specimen(s), and evaluates theirrole in modifying human performance or behaviour. (The analysis of ethanol in breath, althoughimportant, was not considered by the committee because such tests are not conducted in alaboratory setting); andForensic Urine Drug Testing - determines the absence or presence of drugs and their metabolitesin urine to demonstrate prior use or abuse.Standard - a reference material possessing one or more properties that are sufficiently wellestablished that it can be used to prepare calibrators.Calibrator - a solution , either prepared from the reference material or purchased, used tocalibrate the assay. Where possible, calibrators should be prepared in a matrix similar to that ofthe specimens.Control - a solution either prepared from the reference material (separately from the calibrators;that is, weighed or measured separately), purchased, or obtained from a pool of previouslyanalyzed samples. Controls from any of these sources are used to determine the validity of thecalibration; that is, the stability of a quantitative determination over time. Where possible,controls should be matrix-matched to specimens and calibrators, as indicated above.
SOFT / AAFS Forensic Laboratory Guidelines – 20063.Reference Material (RM) - a material or substance one or more properties of which areestablished sufficiently well to be used for calibration of an apparatus, assessing a measurementor assigning values to material. (AOAC Official Methods of Analysis (1984)).Certified Reference Material (CRM) - a reference material, one or more of whose properties arecertified by a valid procedure, or accompanied by or traceable to a certificate or otherdocumentation which is issued by a certifying body. (AOAC Official Methods of Analysis(1984)).4.PERSONNEL4.1Laboratory Director4.1.1 The forensic toxicology laboratory should be directed by a person who is qualified byreason of appropriate education and experience to assume the required professional,organizational, educational, managerial and administrative responsibilities.4.1.2 That education and experience should be comparable to those of persons certified asDiplomates by the American Board of Forensic Toxicology.4.1.3 Alternative acceptable qualifications include a doctoral degree in one of the naturalsciences and at least three years of full-time laboratory experience in forensic toxicology; or aMaster's degree in one of the natural sciences and at least five years of full-time laboratoryexperience in forensic toxicology; or a Bachelor's degree in one of the natural sciences and atleast seven years of full-time laboratory experience in forensic toxicology.4.1.4 The director should also have documented training and/or experience in the forensicapplications of analytical toxicology (such as court testimony, research, participation incontinuing education programs, and/or peer review of appropriate manuscripts in the field),including a knowledge of evidentiary procedures that apply when toxicological specimens areacquired, processed, and stored and when toxicological data are submitted as part of a legalproceeding.4.1.5 The laboratory director should be responsible for ensuring that the laboratory personnelare adequately trained and experienced to conduct the work of the laboratory4.1.6 The laboratory director should be responsible for maintaining the competency oflaboratory personnel by monitoring their work performance and verifying their skills. Thistraining and experience should be documented.4.1.7 The laboratory director should be responsible for the development of a complete,up-to-date procedures manual that is available to and followed by all personnel performing tests.4.1.8 The laboratory director should establish a procedure for validating new analyticalmethodologies, and for maintaining a quality assurance program to ensure the properperformance and reporting of all test results.
SOFT / AAFS Forensic Laboratory Guidelines – 20064.4.1.9 Since forensic toxicology laboratories handle controlled substances and generate resultsessential to the criminal justice system, the director, to the extent practical or permitted by law,should exert reasonable efforts to ensure that all personnel meet high ethical and moralstandards.4.2Other Laboratory StaffThe range and type of duties of other laboratory personnel will vary according to the size and thescope of the laboratory. It is recommended that each laboratory should have the following.4.2.1 A person with the title of deputy director, assistant laboratory director, assistant chieftoxicologist, or supervisory toxicologist, who has sufficient training and experience to befamiliar with all administrative and testing procedures. He or she may supervise the work of allanalysts, and should be capable of performing full scientific review of all test data, and of actingfor the laboratory director in the director's absence. It is recommended that such individualsshould have a minimum of a Bachelors degree in a natural science and 3 years of training inanalytical toxicology, at least 1 year of which is in forensic toxicology.4.2.2 One or more technicians who are capable of performing a variety of test procedures foralcohol, drugs, and other chemicals. A technician may supervise and review the work of lessexperienced technicians, and may supervise a section in a larger laboratory. It is recommendedthat such individuals should have a minimum of a Bachelor's degree in a natural science, at least1 year of experience in analytical toxicology and 6 months experience in the presentemployment.4.2.3 One or more analysts who are capable of performing tests for one or several analytes, andwho are certified in each procedure by the laboratory director. These analysts may be limited infunction to perform specified tasks - for example, an analyst who performs only immunoassays.5.STANDARD OPERATING PROCEDURES5.1The laboratory should have a standard operating procedure manual (SOP) that iscomplete, up-to-date, and available to all personnel who are performing tests.5.2The SOP manual should include detailed descriptions of procedures for sample receiving,accessioning, chain-of-custody, analysis, quality assurance and quality control, review of data,and reporting.5.3The SOP manual should include administrative procedures as well as analytical methodsand be reviewed, signed, and dated whenever it is first placed into use or changed.5.4The SOP manual should include, for each analytical procedure if appropriate, thefollowing: a) theory and principle of the method, b) instructions for preparation of reagents, c)
SOFT / AAFS Forensic Laboratory Guidelines – 20065.details of the analytical procedure, d) instructions for preparation of calibrators and controls, e)information about any special requirements for handling reagents or for ensuring safety, f)validation parameters (e.g. LOQ, linearity), g) criteria for the acceptance or rejection ofqualitative or quantitative results and h) references.5.5When the required documentation is not available for infrequently performed assays, itshould be added as each is performed for the first time.5.6The SOP should contain a record of sample signatures and initials of all staff handlingspecimens and performing analytical work (i.e. a “signature page”). This should be updated asneeded to reflect staffing changes.5.7The laboratory should maintain out-dated copies of the SOP manual and provide a meansfor their retrieval from archival storage.6.SAMPLES AND RECEIVING6.1Specimen Collection and LabellingThe proper selection, collection, and submission of specimens for toxicological analyses is ofparamount importance if analytical results are to be accurate and their subsequent interpretationis to be scientifically sound and therefore useful in the adjudication of forensic cases. Theseguidelines can apply equally to investigations by Medical Examiners or Coroners (postmortemforensic toxicology) and to investigation by law-enforcement agencies of cases involving humanperformance issues.6.1.2 The director should develop and provide detailed guidelines and instructions to allagencies or parties the laboratory serves.6.1.3 Instructions should state the types and minimum amounts of specimens needed toaccomplish the requisite analyses and subsequent interpretations.6.1.4 Whenever possible, the amount of specimen collected should be sufficient to ensure thatenough remains for subsequent re-analysis if required.6.1.5 Instructions should include specific requirements for the type and size of specimencontainers and, if appropriate, the type and amount of preservative to be added to biologicalfluids.6.1.6 Instructions for labelling individual specimen containers, and acceptable conditions forpacking and transportation, should also be provided.6.1.7 Submitting agencies should be instructed to indicate relevant medical history on livingsubjects or decedents who may carry a highly infectious disease such as tuberculosis, hepatitis or
SOFT / AAFS Forensic Laboratory Guidelines – 20066.Human Immunodeficiency Virus. However, laboratories should adopt “universal precautions”when handling biological specimens, regardless of reported medical history.6.1.8 Each specimen should be identified as to type. For blood, the anatomical site ofcollection should be stated. When antemortem and/or perimortem specimens are available froma decedent, each specimen should be labelled with the time and date of collection.6.1.9 The name of the subject from whom the specimens were collected should appear on eachlabel together with other appropriate identification; for example, the Medical Examiner's CaseNumber and/or the subject s Social Security Number.6.1.10 Where provided, the time and date registered for each specimen should be initialled orsigned by a responsible person who performed or witnessed the collection and who assum
Forensic Toxicology. However, the Guidelines Committee agreed that there were many additional issues which were important to cover, but which might better belong in a supplementary document - the Appendix to the Guidelines. Since 1991, the profession has matured in many ways. In 1996 the American Board of Forensic Toxicology launched a Forensic .
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