KSL becomes the first A2LA ISO 15189 certified laboratory in New York State
BUFFALO, NY—KSL Diagnostics has been certified by the American Association for Laboratory Accreditation (A2LA) for technical competence in the field of clinical testing, ISO 15189:2012 Medical laboratories — Requirements for Quality and Competence.
With this latest accreditation, KSL Diagnostics expands its impressive set of credentials—including CLIA, New York State and nationwide state licensure, and College of American Pathologists (CAP) accreditation.
Less than 1% of licensed laboratories hold this certification. KSL’s comprehensive quality and regulatory qualifications in broad technical categories make it an ideal partner for regional, national and international clinical laboratory testing and trials.
KSL's ISO 15189:2012 Medical laboratories — Requirements for Quality and Competence certificate
“Since the beginning, we embraced quality throughout the organization,” Kevin J. Lawson, President and CEO of KSL Diagnostics said. “This achievement is the result of the supreme dedication to continual improvement by everyone here. Our investment in ISO 15189 will unlock more national and international laboratory contracts for KSL Diagnostics and the Western New York region.”
ISO 15189 is an international standard that specifies the quality management system requirements including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff. The standard is based on ISO/IEC 17025 and ISO 9001, with a focus on the medical environment and the importance of the medical laboratory to patient care.
“The past year has been historically challenging,” added Beverly Sobilo, Corporate Quality Manager for KSL Diagnostics. “During this time, our management team worked tirelessly to create and expand COVID-19 testing capabilities to serve our local communities, open an FDA-registered manufacturing facility, and inspire our entire organization to build a quality system we can truly be proud of to achieve our goal of ISO certification.”
A2LA Accreditation is synonymous with both quality and competence of an organization, based on international standard(s). A2LA is among the largest accreditation bodies in the world and the only independent, 501(c)3, non-profit, internationally recognized accreditation body in the United States that offers a full range of comprehensive conformity assessment accreditation services. A2LA is dedicated to the formal recognition of competent testing and calibration laboratories (including medical laboratories), biobanking facilities, inspection bodies, product certification bodies, proficiency testing providers, and reference material producers.
KSL Biomedical Inc. was founded to utilize translational medicine pipelines to deliver innovative diagnostics and therapeutics. KSL invests in basic research and in-licensing of novel technologies to improve patient outcomes, particularly in cases requiring early diagnosis or companion diagnostics to facilitate effective therapy. Find out more at www.kslbiomedical.com.
As a channel for diagnostic services, KSL has established a New York State Department of Health / CLIA certified clinical laboratory licensed throughout the US, KSL Diagnostics, Inc. The rapidly expanding test menu includes leading edge assays based on KSL IP as well as standard of care diagnostics supported by superlative clinical consultation and customer service. Find out more at www.ksldx.com.
Kevin Lawson, President and CEO