Quality Assurance Guidelines for Laboratories Performing Microbial Forensic Work
Produced by the Members of the Scientific Working Group on Microbial Genetics and Forensics (SWGMGF)
Contact: Bruce Budowle, Chair, FBI Laboratory, 2501 Investigation Parkway, Quantico, Virginia 22135
June 20, 2003
The Scientific Working Group on Microbial Genetics and Forensics (SWGMGF) has developed the following quality assurance guidelines to provide laboratories engaged in microbial forensic analysis with a framework to implement a quality assurance program. This document provides guidance to laboratories that carry out microbial forensic analysis to support the judicial system. Consideration may be given to alternate methods of achieving the intent of these quality assurance practices as outlined in these guidelines. A quality program is always evolving, and likewise, this document should be considered a living document. It is the intent of SWGMGF to modify this document as quality assurance practices in microbial forensics advance.
The Quality Assurance Guidelines for Laboratories Performing Microbial Forensic Work provides a baseline from which laboratories may structure their quality assurance practices. Many of the recommendations outlined in this document will be familiar to laboratories already meeting ISO 17025 and CLIA '88 requirements. It is the intent of SWGMGF to provide the community with a source document for quality practices in the microbial forensics field.
American Society of Crime Laboratory Directors-Laboratory Accreditation Board (ASCLD/LAB), ASCLD/LAB Accreditation Manual, April 2001.
Federal Bureau of Investigation, Quality Assurance Standards for Forensic DNA Testing Laboratories (1998).
International Standards Organization (ISO)/International Electrotechnical Commission (IEC), ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories (1999) American National Standards Institute, New York, New York.
U.S. Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, Fourth Edition, U.S. Government Printing Office, Washington, DC, April 1999.
CLIA '88. Code of Federal Regulations. Washington, DC, U.S. Government Printing Office, 2001, 57 CFR 7139 pp 883-999.
42 Code of Federal Regulations, Chapter IV (10-1-95 Edition), Health Care Financing Administration, Health and Human Services.
The CDC Interim Final Rule 42 CFR Part 73 Possession, Use, and Transfer of Select Agents and Toxins; Interim Final Rule; FR citation: 67 FR 76886.
The APHIS Interim Final Rule 7 CFR Part 331, repeated at 9 CFR Part 121 Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins; Interim Final Rule; FR citation: 67 FR 76908.
These guidelines describe quality assurance activities that a laboratory should follow to ensure the competency of the laboratory and the quality and integrity of scientific data. A laboratory, in the context of these guidelines, is defined as a facility in which microbial forensic testing is performed. These guidelines do not preclude a laboratory, by itself or in collaboration with others, from participating in research and development, or from using procedures that have not yet been validated by standard means for purposes other than forensic testing.
As used in these guidelines, the following terms have the meanings specified:
Administrative review is an evaluation of examination documentation for consistency with laboratory policies and for editorial correctness.
Analytical procedure is an orderly step-by-step procedure designed to ensure operational uniformity and to minimize analytical drift.
Attribution is the information obtained regarding the identification or source of a material to the degree that it can be ascertained. …