The U.S. Army Medical Research Institute of Chemical Defense, at Aberdeen Proving Ground, Maryland, recently became the first organization laboratory within the Department of Defense to receive full accreditation as a high complexity clinical laboratory for diagnostic testing on human samples to confirm exposure to chemical threat agents. Additionally, the USAMRICD is the first DOD institute to achieve Clinical Laboratory Improvement Plan accreditation through the American Association for Laboratory Accreditation, an approved international accrediting body.
The USAMRICD has a long history of developing analytical tests to confirm chemical agent exposure; however, up until now, any results from exposure-confirmation testing done on a human sample from a service member were not eligible to become part of the service member's health record because the testing was not done in a clinical laboratory. The Institute's new accreditation will make these important confirmatory results available for providers.
According to Maj. Gen. Barbara Holcomb, commanding general of the U.S. Army Medical Research and Materiel Command and Fort Detrick, "This new capability at the USAMRICD is a significant asset for the Department of Defense in that it addresses a previously unmet need."
"Given the recent world events involving the use of chemical warfare agents, it is more important than ever for rapid and secure exposure-confirmation testing to support real time missions, and for testing results to be included in the Military Service Member Health Records," said Holcomb.
To add this new capability, the Institute first established a dedicated clinical laboratory, separate from its analytical chemistry laboratories, to conduct clinical verification testing according to standing operating procedures governing the process. When all the necessary requirements were in place, USAMRICD's clinical laboratory and Quality Management Office invited the Defense Health Agency's Center for Laboratory Medicine Services, which grants a certificate of registration under CLIP, to visit as part of the Institute's submission package. CLIP ensures quality and reliability in laboratory testing performed on human samples to diagnose, prevent, or treat a disease, or to assess the health of the individual from whom the sample was collected. Under CLIP the validation process for clinical testing is much more stringent than, or different from, that used in research environments.
The final step to accreditation was a thorough quality and technical audit by the A2LA. The USAMRICD had an unprecedented "zero deficiencies found" during the accreditation process.
USAMRICD's QMO chief, Dr. Cheri Roseberry, outlined the accreditation process.
"The Institute had to demonstrate an ability to monitor all aspects of the clinical laboratory to rigorous international standards through a regimented quality management program. All aspects of the quality and laboratory systems were scrutinized: equipment, records, personnel files, standard operating procedures and laboratory processes. In addition to all of the preparation and internal audits, the clinical laboratory and quality program were inspected and evaluated by outside agencies."
The process of establishing a clinical laboratory and receiving CLIP registration occurred under the leadership of Col. Margery Hanfelt, who recently completed her tour as commander of the Institute.
"The USAMRICD is uniquely qualified for high complexity diagnostic testing of human samples for chemical agent threats," said Hanfelt. "With its world-class medical and research subject matter experts working together in state-of-the-art facilities, the USAMRICD is the medical chemical defense leader for the Department of Defense."
The Institute's subject matter experts cover a broad range of clinical and research sciences. Clinical SMEs include physicians with specialties in medical toxicology, anatomic and clinical pathology, occupational medicine, and allergy and immunology; a nurse anesthetist with a doctorate in neurophysiology; medical laboratory scientists and technicians, and current and former medics from varying service branches. Among the research specialists on the Institute's staff are synthetic, analytical and medicinal chemists, inhalation toxicologists, biochemists, pharmacologists, biomedical and chemical engineers, physiologists, psychologists, and cellular and molecular biologists, as well as representatives of other bioscience disciplines.
Col. Denis Descarreaux assumed command of the USAMRICD in late July, just prior to its receipt of full accreditation from A2LA. "Establishing this new capability is an impressive accomplishment for the USAMRICD. Its importance to the DOD cannot be overstated," said Descarreaux. "We look forward to continuing to expand our clinical testing capabilities."
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