LABORATORY ACCREDITATION in FORENSIC TOXICOLOGY
Eligibility
Applicant laboratories must be actively engaged in the practice of either or both of Postmortem Forensic Toxicology or Human Performance Toxicology (e.g. DUID-type toxicology), to include at least the detection, identification and quantitation of alcohol and other drugs in biological specimens.
Only laboratories located within the United States of America and its territories and possessions, or of Canada and its territories are eligible for Accreditation.
Program Outline
The Laboratory Accreditation Program is based on the report of the joint SOFT/AAFS Forensic Laboratory Guidelines Committee (March 1991 and subsequent revisions), additional recommendations of the Guidelines Committee (February 1994) and of the Accreditation Committee of the ABFT. However, it is the responsibility of the ABFT to set the criteria to be applied in deciding whether a laboratory meets the minimum requirements necessary for accreditation to be granted.
The goal of the program is to enhance and maintain standards of practice for the detection, identification and quantitation of alcohol, drugs and other toxins in biological specimens.
Applicant laboratories are required to successfully participate in at least one alcohol and one non-alcohol (drug) proficiency testing program for 12 months prior to application.
Applicant laboratories must submit: i) A completed application form and self-evaluation checklist, ii) Relevant proficiency test results for the past 12 months (to include evidence of corrective action where program criteria were not met); iii) A litigation package for a case involving a positive blood alcohol result and a case involving one positive, quantitative blood drug result (which may be the same or separate cases).
The program cycle is 2 years. Laboratories must submit to an on-site inspection at least once every 2 years (normally 2-inspector, 2-day: up to 3-inspector, 3-day).
Checklist questions are designated either Essential, Important or Desirable. All Essential questions must be answerable "yes" before accreditation can be granted. The laboratory must also satisfy at least
90% of the Important questions and at least 75% of the Desirable questions.
Proficiency Tests
Enrollment in the CAP Toxicology Program (T-series) is highly recommended as an acceptable "non-alcohol" proficiency testing program. However, other acceptable programs could include combinations of FAA forensic toxicology program, CAP urine toxicology program, CAP forensic urine drug testing program, CAT Proficiency Testing Program, CSFS Proficiency Testing Program.
Where criteria for acceptable performance in the program are suggested by the
sponsor, these will be used. Otherwise, "acceptable performance"
will be determined by the Accreditation Committee, but will be based in part on
the following: no false positives; ethanol within ±2 S.D. of the participant
mean or ±10% weighed-in target; for drugs the challenges should be within ±2
S.D. participant mean or ±30% weighed-in target for drugs. Corrective action
must be documented for false negatives and other deficiencies, appropriate for
the stated mission of the laboratory. The Accreditation Committee may, in
its discretion, rule accept proficiency test results outside these ranges if the
laboratory can demonstrate that appropriate has been taken, and that the errors
are not systematic and unlikely to re-occur.
Areas of testing within the laboratory other than Postmortem Forensic Toxicology or Human Performance Toxicology, will not be evaluated, unless there is overlap.
Duration of Accreditation
Accreditation is for one year initially. An extension will be given for a second year, subject to satisfactory review of a self-inspection checklist and of relevant proficiency test results for the 12 months following initial accreditation.
Accreditation Extension
Towards the end of the first year of the 2-year accreditation cycle, a letter will be sent out to the laboratory, requesting completion of a Self Evaluation Checklist and submission of relevant proficiency test summaries for the previous 12 months. In addition, the laboratory will be required to submit documentation of any corrective action that was required to address by the end of the first year of the accreditation 2-year cycle.
Reaccreditation
Towards the end of the second year of the 2-year cycle, a letter will be sent out to the laboratory, inviting application for reaccreditation. The same requirements and procedures apply to reaccreditation as applies to initial accreditation.
The Procedures for Application and Certification are given separately.
General Provisions Concerning Accreditation
The right to deny accreditation is reserved.
Certificates of Laboratory Accreditation in Forensic Toxicology are valid for one (1) year and are renewable for a second year, according to the standards and conditions established by the Board.
Laboratories holding Certificates of Accreditation are entitled to state on reports, or in other appropriate manner that they are "Accredited by the American Board of Forensic Toxicology, Inc."
A list of currently accredited laboratories is given separately.
Certificates issued by the Board are not transferable. They remain the property of the Board, but every laboratory to whom a Certificate has been properly issued is entitled to its continued possession unless such Certificate is revoked.
Certificates may be suspended or revoked for appropriate cause, under an elaborate system of safeguards for the laboratory concerned.
Requirements and application procedures for accreditation are subject to revision by the Board. The latest version is available from the above address.
Successful applicants are issued a Certificate of Laboratory Accreditation in Forensic Toxicology, and the name of the laboratory is published in the next newsletter of the ABFT and from time to time in other publications at the discretion of the Board.
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