Tamika Givens McSweeney

Laboratory Quality & Regulatory Compliance Consultant | CLIA, CAP, State Inspection Readiness & Lab Startup Support I am a senior laboratory professional with more than 25 years of experience in the healthcare and clinical laboratory industry, supporting hospital laboratories, reference laboratories, and specialized diagnostic testing environments. My expertise centers on quality management systems, regulatory compliance, and operational leadership, helping organizations strengthen their laboratory infrastructure while maintaining regulatory readiness and high-quality diagnostic services. Throughout my career, I have contributed to the development and operational launch of more than 15 laboratories across the United States, supporting laboratory startups, service expansions, and operational improvements. I have extensive experience guiding organizations through regulatory inspections and accreditation processes, with a strong track record of success under CLIA, CAP, COLA, and various state and federal regulatory programs. My background includes the design and implementation of comprehensive quality, compliance programs and laboratory department setup, including the development of laboratory quality systems and the establishment of dedicated quality and compliance departments. I have provided regulatory oversight across multiple operational divisions, including laboratory operational oversight, revenue cycle and billing functions, clinical trial support, phlebotomy services, and organizational compliance programs. I possess management and operational experience across multiple laboratory specialties with strong focus and knowledge of Molecular Pathology. My consulting approach combines regulatory expertise, operational strategy, and practical laboratory leadership, helping organizations build sustainable systems that support compliance, operational efficiency, and reliable diagnostic testing. Clinical laboratories play a critical role in patient care. I am committed to supporting laboratory teams as they navigate a complex regulatory environment while maintaining the highest standards of quality and patient safety. I work collaboratively with laboratory leadership and operational teams to assess current systems, identify regulatory or operational gaps, and implement practical solutions that strengthen compliance and operational efficiency. My approach focuses on building sustainable laboratory systems that support long-term regulatory readiness, operational stability, and high-quality patient testing services.

Nationwide (except CA)