Better CLIA Compliance

Denise Driscoll, MS, MT(ASCP), SBB, is the Senior Director of Laboratory Accreditation and Regulatory Affairs at the College of American Pathologists (CAP), where since 2004, she has been responsible for the overall management of accreditation decisions, accreditation requirements, and regulatory and customer relationships. Denise received the CAP’s Laboratory Accreditation Program Service Award in 2011 and has served both as an assessor and a member of the Education Committee with the American Association of Blood Banks, where she has been a member for more than 20 years. Before joining the CAP in 1995, Driscoll worked as a laboratory manager and laboratory supervisor (blood bank and apheresis) at the University of Alabama Medical Center and also as a blood bank sales representative with Immucor, Inc. Driscoll received her BS in medical technology from Auburn University in Auburn, AL, and her MS in clinical laboratory science with a specialty in blood bank technology from the University of Alabama at Birmingham.

Nora Hess, MBA, MT(ASCP), Senior Consultant for Accumen, has 18 years of experience in laboratory consulting. Her major areas of expertise are regulatory and accreditation compliance, laboratory operations, strategy, workflow efficiency and space design. Prior to her consulting experience Nora was an Administrative Laboratory Director for 12 years in Florida. She is a frequent speaker at laboratory conferences on a wide range of laboratory topics.

Carlyn Mathews is the Clinical Program Manager at the American Association for Laboratory Accreditation (A2LA). She joined A2LA in February of 2018, and she runs the Clinical Program. The Clinical Program includes the CLIA, CLIP, Platinum, and ISO 15189 programs. In addition to the Clinical Program, Mathews facilitates the day-to-day operations of accreditation by assisting clients in obtaining and maintaining accreditation in the chemical, biological, and clinical fields of testing. Mathews obtained a bachelor of science in chemistry with a minor in mathematics from Indiana University of Pennsylvania in Indiana, PA.

Kathy Nucifora, MPH, MLS(ASCP), joined COLA as the Accreditation Division Manager in November 2009 and then served as Director of Accreditation before her promotion to COO in 2019. Kathy was previously with the University of Maryland Medical Center Midtown Campus, where she held the position of Laboratory Administrator. Kathy was recruited from a laboratory in Kansas, to join UMMC Midtown, where she was responsible for a busy inner-city laboratory. In addition to managing the day-to- day operations of the laboratory, she led a multidisciplinary task force to implement molecular testing for MRSA; she launched a positive patient identification system via handheld computers; and helped lead the Laboratory and Nursing Process Improvement Committee. Kathy has also previously served as adjunct faculty at the Community College of Baltimore County for their Medical Laboratory Technician program.

Since 2021, Amy Null, MBA, MT(ASCP), SBB, serves as an Associate Director in the Standards Interpretation Group for The Joint Commission’s Laboratory Accreditation program. After joining The Joint Commission in 2016, Amy worked as a laboratory surveyor for five years. Prior to joining The Joint Commission, Amy served as System Director of Laboratory Services for a large healthcare system in Columbus, Ohio. Amy earned an MBA from Franklin University, an SBB from The American Red Cross/The Ohio State University, and a Six Sigma Black Belt Certification from Breakthrough Management Group. She has a bachelor of science in allied health professions from The Ohio State University, and is member of the American Society for Clinical Pathology and Clinical Laboratory Management Association.

Lindsay Strotman, PhD, is a board-certified laboratory director on the team of Lighthouse Laboratory Services. Strotman has experience directing high-complexity molecular and toxicology laboratories. She received her doctorate from the University of Wisconsin-Madison where she developed microfabricated devices and assays to streamline sample preparation workflows for a variety of molecular diagnostic application areas. Strotman continued building on this work, serving in different research and development and regulatory compliance roles in academia and the private sector. Specifically, she was instrumental in validating several laboratory developed tests and assuring CLIA, CAP and COLA regulatory requirements were met. Strotman has also received multiple patents, published in peer-reviewed journals, and written several funded grants.