Mark Gusack

Mark Gusack, PhD

Principal Consultant & Practice Lead
  • mark.gusack@labshire.com
  • (844) 686-5750

Mark is a former Nuclear Medicine Technologist, Clinical Engineer, and General Pathologist with extensive background in a variety of ancillary fields.  These include but are not limited to:

  • Fifty years as a programmer including Artificial Intelligence in the educational and healthcare fields
  • Forty years in database design including Laboratory Information and Quality Systems
  • Forty years in the assessment, implementation, and management of Laboratory Information Systems
  • Thirty years in Statistical Process Control in laboratory operations as well as manufacturing
  • Twenty-five years in Knowledge Management and Document Management in the laboratory field
  • Thirty years in design and oversite of invitro research studies and clinical trials
  • Forty years working in the allied fields of Risk, Quality, and Utilization Management

Over the years Mark has designed, set up, directed, inspected, and accredited laboratories

He has experience as a hospital medical director and has done consulting work for numerous laboratories, pharmaceutical companies as well as healthcare organizations including the Clinical Laboratory Standards Institute, The Society to Improve Diagnosis in Medicine, and the American Association for Laboratory Accreditation.

Mark has recently been involved with the design and oversite of invitro studies for a startup pharmaceutical company to characterize metrological aspects of drug delivery systems as well as work for other pharmaceutical companies reviewing analytical methods, validation-related documentation, quality assurance, and quality systems-related documentation. He is experienced in scientific writing, manuscript writing, and grant writing for various academic institutions.

In addition, Mark has published articles on laboratory instrument validation as well as a monograph on healthcare management.  He regularly presents at conferences in the fields of diagnostic error reduction and laboratory management.  He holds patents in the field of associative database technology and telepathology.

Education

BA, History plus majors in Mathematics and Combined Sciences – Amherst College, MA 1976

Medical Doctorate – The George Washington University School of Health Sciences, D.C. 1980

Residency in Anatomic and Clinical Pathology – Tripler Army Medical Center, HI 1984

Board Certified in Anatomic and Clinical Pathology 1984

Licensed Risk Manager – Clearwater Risk Management Institution, FL 1993 – 2000