The landscape of toxicology testing- both clinical and forensic- is drastically changing. This is due to several key factors: 1) The National Academy of the Sciences (NAS) Report on Strengthening Forensic Sciences in the United States and its ramifications and 2) The large influx of new toxicology testing laboratories due to the possible reimbursement structures which are quite attractive to many. These aforementioned factors seem to be in direct conflict with one another; as the latter generally does not have the expertise to adhere to strict quality guidelines.
The crux of the NAS Report is the need for oversight regulations and a common standard for the guidance of toxicology laboratories. Currently, the Department of Health and Human Services regulates these aforementioned laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). To date to ensure confidence in testing, CLIA relies on two measures: controls and proficiency testing. CLIA requires that control materials be used, but does not define how they must be used. A laboratory can simply run control material and be compliant with the edicts of CLIA without specific source requirements or acceptance criteria. Moreover, the second quality statue of CLIA, proficiency testing, only requires participation in a program. It does not have passage rate acceptance criteria.
Taken together, the NAS Report concluded that there may be several toxicology laboratories that test patient samples that do not have the leadership, scientific acumen, or guidelines to provide quality results which can lead to negative outcomes for the patients. It has suggested reorganization of the current Scientific Working Groups to assist in providing the guidelines needed to improve patient outcomes. This reorganization will occur under the National Institute of Standards and Technology. Also, the Agency for Healthcare Research and Quality (AHRQ) has suggested patient-outcome centered, quality-driven grading of laboratories in healthcare.
Quality is the cornerstone of all activities here at Western Slope Laboratory, LLC. Recognizing that the CLIA guidelines did not provide what was needed to ensure the highest quality in testing; Western Slope sought out and became compliant with ISO 17025:2005. Starting the process in 2007 with researching the Standard, scientists at Western Slope investigated how applicable it was to clinical and forensic toxicology in comparison with ISO 15189:2007. After selecting ISO 17025:2005, the process of selecting an accrediting agency began. Concurrently, staff at Western Slope became familiar with all the edicts and requirements of the Standard. In May 2013, Western Slope Laboratory became the first ISO 17025:2005 forensic drug testing laboratory accredited by the American Association for Laboratory Accreditation (a2la). This accreditation demonstrates the commitment that Western Slope has to quality and our continual improvement efforts. To learn more about our quality processes or if you have any questions on our scope please contact our Director of Quality today.