Clinical Laboratory and Blood/Tissue Bank Services

  • Holland & Knight's Healthcare & Life Sciences Team has the first-hand experience and resources required to support clinical laboratories and related businesses.
  • We offer wide-ranging services - from litigation and regulation to contracting and reimbursement procedures – and nearly everything in between.
  • Members of our team interact regularly with the Centers for Medicare and Medicaid Services on public healthcare matters, reimbursement policy and compliance issues.

The rising cost of services and rapid advances in technology have created tremendous change in the structure and organization of healthcare services for providers and related businesses. Nowhere is this truer than for owners and operators of hospitals, clinical laboratories, pathology groups and blood/tissue bank facilities – for whom a proliferation of healthcare regulatory and compliance issues complicate day-to-day operations.

Protecting Your Interests in Today’s Regulatory Environment

With nearly 100 years of practice in healthcare law and firsthand experience supporting laboratory and related business areas – from major independent clinical labs, hospitals, and skilled nursing facilities to physician offices – Holland & Knight’s Healthcare Team has the resources to guide you past the regulatory pitfalls.

Whether you seek support for a healthcare research study or need to ensure compliance with current HIPAA law provisions, Holland and Knight’s Healthcare attorneys are able to leverage core industry experience while drawing on the firm’s vast resources from related practice areas – including appropriations, litigation, HIPAA law and Food and Drug, among others.

Unique Insight into Your Industry

Ensuring that your lab or facility is compliant with the changing regulatory environment requires a broad based core knowledge combined with insight into the industry itself. Many of Holland & Knight’s Healthcare Team members are authorities in the areas of clinical laboratory and related healthcare businesses. Authors and frequent speakers on the legal issues impacting your industry, these attorneys are nationally recognized for their knowledge and proficiency in the practice of clinical laboratory law and interact regularly with the Centers for Medicare and Medicaid Services on public health law matters, reimbursement policy and compliance issues.

Areas of Service

Holland & Knight’s Healthcare Team will protect your interests in these and other related areas of service:

  • compliance – federal and state policy fraud and abuse laws; federal and state blood/tissue banking regulations; Clinical Laboratory Improvement Act; establishment and implementation of programs ensuring compliance with healthcare law
  • reimbursement procedures – Medicaid and Medicare law; new clinical laboratory assays using analyte-specific reagents; In Vitro Diagnostic Multivariate Index Assays
  • privacy policies – full-scale security, operational compliance assessments and remediation programs; development of HIPAA privacy policies/procedures; drafting of business associate agreements and of HIPAA law assessment tools; public healthcare and privacy issues
  • outreach programs – counseling on the establishment of hospital clinical laboratory service outreach initiatives
  • Food and Drug Administration matters – advise on FDA requirements for the development of In Vitro Diagnostic Multivariate Index Assays, new clinical laboratory assays and analyte-specific reagents
  • contracting issues – advise on contracting considerations between tissue sources and processors