Definitions

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.

Audit is an inspection used to evaluate, confirm, or verify activities related to quality.

Biocrime or bioterrorism is the threat or use of microorganisms, toxins, pests, prions, or their associated ancillary products to commit acts of crime or terror.

BMBL is the Biosafety in Microbiological and Biomedical Laboratories (see Bibliography).

Calibration is a set of operations that establish, under specified conditions, the relationship between values provided by a measuring instrument, measuring system, and a known material or known values.

CDC is the Centers for Disease Control and Prevention.

Chain of custody is the tracking and documentation of physical control of evidence.

Contributing agency is identified as the organization that submitted the evidence to the laboratory for testing and which will receive the laboratory report.

Control samples or known samples are test materials whose identity, type, or values have been established (e.g., blind samples, negative and positive controls).

Critical equipment or instruments are those requiring calibration prior to their initial use and on a regular basis thereafter.

Critical reagents are determined by empirical studies or routine practice to require testing on known samples prior to use with evidentiary materials in order to prevent unnecessary consumption of forensic samples.

Derivative evidence is material having originated from the original evidence (e.g., grown cultures, amplified DNA).

Examination documentation encompasses any documentation generated as a result of the analysis of submitted evidence. This may include technical notes, worksheets, charts, graphs, printouts, spectra, photographs, and other data or records used by examiners/analysts to support their reported conclusions.

Examiner/analyst (or equivalent role, position, or title as designated by the laboratory director) is an individual who conducts and/or directs the analysis of samples, interprets data, and reaches conclusions, and may eventually testify to those findings or conclusions.

Expert testimony is an opinion rendered by a qualified individual based on technical expertise or training.

Investigative support is data that provide the contributing agency with basic information to assist an ongoing investigation.

Laboratory is a facility in which microbial forensic testing is performed, a facility that contracts with another entity for such testing, or an entity contracted to perform analyses.

Laboratory support personnel (or equivalent role, position, or title as designated by the laboratory director) is an individual(s) performing supportive laboratory duties, but is not involved in the analysis or interpretation of evidence.

Microbial forensics is a scientific discipline that examines microorganisms, toxins, pests, prions, or their associated ancillary products for source attribution.

Proficiency test samples are materials whose identity, type, or values have been previously characterized and are used to assess the performance of a laboratory or an individual(s).

Proficiency testing is a quality assurance measure used to monitor performance and identify areas where improvements may be needed. Proficiency tests may be classified as:

• Internal: A proficiency test that is prepared and administered within the laboratory being tested.

• External: A proficiency test that is prepared by an external agency.

Qualifying test measures an individual's proficiency in both technical skills and knowledge and is administered prior to an individual assuming independent work responsibility.

Quality assurance is the system of management activities designed to ensure that a process, item, or service is of the type and quality needed. This includes monitoring activities that are intended to verify whether practices and test results are providing reliable and relevant information.

Quality control is a mechanism or laboratory activity intended to verify whether test conditions are functioning appropriately to yield reproducible results.

Quality manual is a document stating the quality policy, quality system, and quality practices of an organization.

Quality system is the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

Reference material (certified or standard) is a material for which identities, types, or values are certified by technically valid procedures and is accompanied by, or traceable to, a certificate or other documentation.

Secure area is a locked space (e.g., cabinet, vault, room) with access restricted to authorized personnel.

Subcontractor is an individual or entity having a transactional relationship with a laboratory.

Technical manager (or equivalent position or title as designated by the laboratory director) is the individual who is accountable for the technical operations of the laboratory.

Technical review is an evaluation of reports, notes, data, and other documents to ensure that an appropriate and sufficient basis exists for the reported scientific conclusions.

Technician (or equivalent role, position, or title as designated by the laboratory director) is an individual who performs analytical techniques on samples under the supervision of an examiner/analyst.

Traceability is the property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons.

uSDA is the United States Department of Agriculture.

Validation is a process by which a procedure is evaluated to determine its efficacy and reliability for analysis and includes the following:

• Developmental validation is the acquisition of test data and the determination of conditions and limitations of a newly developed methodology for use on samples.

• Preliminary validation is the acquisition of limited test data to enable an evaluation of a method used to assess materials derived from a biocrime or bioterrorism event.

• Internal validation is an accumulation of test data within the laboratory to demonstrate that established methods and procedures perform within determined limits in the laboratory.

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