About Us
NBI Testing and Consulting Corporation was founded by Dr. Steve Pieczenik MD, PhD and Dr. John Neustadt, ND.
John Neustadt, ND is medical director of Montana Integrative Medicine and president and CEO of Nutritional Biochemistry, Inc and NBI Testing and Consulting Corporation in Bozeman, Mont. Dr. Neustadt has published more than 100 research reviews, is co-author with Jonathan Wright, MD, of the book, Thriving through Dialysis (Dragon Arts Publishing, Auburn, Wash, 2006), and an editor of the of the textbook, Laboratory Evaluations for Integrative and Functional Medicine (Metametrix Clinical Laboratory, Norcross, GA, 2007). Drs. Neustadt and Pieczenik recently wrote the book, A Revolution in Health through Nutritional Biochemistry (iUniverse 2007).
Steve Pieczenik, MD, PhD trained in psychiatry at Harvard and has both an MD from Cornell University Medical College and a PhD in International Relations from M.I.T. He is a board-certified psychiatrist and was a board examiner in psychiatry and neurology. He is chairman of the board of NBI Testing and Consulting Corporation.
Laboratory Quality Control
Our lab is certified under the US FDA Clinical Laboratory Improvement Amendment (CLIA) passed in 1988, and is qualified to perform high complexity clinical testing. We are currently being certified and accredited through the COLA (Commission of Laboratory Accreditation) program, and separately licensed in Florida, New York, Georgia, Pennsylvania, Rhode Island, Maryland due to specific licensing requirements by those states. Additionally, we participate in proficiency testing through the following agencies/programs: Micronutrient Assurance Program, College of American Pathologists, American Association of Bioanalysts, NY State Certification, Quebec Certification, DEQAS Participation.
As a specialty laboratory, the assays offered though NBI Testing and Consulting Corp (NBITC) are not available as US FDA cleared tests because of the small market in which they occupy. These tests have been developed and independently validated in accordance to CLIA proficiency testing criteria for acceptable analytical performance. Although these assays have not been cleared or approved by the FDA, it should be noted that the FDA does not require these types of in-house testing to go through pre-market FDA review. Regulations as defined by CLIA provide the appropriate oversight for a lab offering specialty testing. CLIA governs all lab operations including accreditation, proficiency testing, quality assurance, quality control, records and information systems, test methods, equipment, and instrumentation. Regulations set under these operations are designed to assure reliability and consistency of laboratory test results. NBITC strictly abides by CLIA guidelines for monitoring and evaluating the quality of our analytical assays, a quality that has defined NBITC as a trusted name in specialty testing.
These comprehensive test interpretations are an invaluable tool for patient management providing detailed status into all analytes tested, with concise nutritional support guidelines. Additionally, as a consulting company, we work with individual doctors and organizations to help them implement this testing in their clinic, and provide detailed test reports that contain customized nutrient recommendations and differential diagnoses.
