House Bill 6836 (sHB6836 File No. 587) revises the existing law regarding the regulation of blood plasma collection by defining new terms such as "blood collection facility," "plasmapheresis," and "source plasma donation center," and updating the definition of "clinical laboratory." It also mandates that the Department of Public Health (DPH) adopt regulations for these facilities, including standards for operations, personnel qualifications, and specimen collection to ensure public health and safety. The bill requires that any person or business entity must obtain proper licensing or approval from the DPH to establish or operate a clinical laboratory, blood collection facility, or source plasma donation center. Facilities registered before October 1, 2023, must apply for an initial license within 30 days after the DPH implements licensure procedures, and the bill includes provisions for facility inspections and enforcement of regulations.

The bill increases the nonrefundable application fee for licensure from $200 to $650, except for laboratories owned by governmental entities, and specifies that licenses are issued for a minimum of twenty-four months with biennial renewal required. It also exempts mobile or temporary blood collection facilities from obtaining a license if they are already licensed as a blood collection facility. The bill outlines disciplinary actions for violations, extends whistleblower protection to employees, and sets fines for non-compliance. The DPH commissioner is tasked with adopting regulations for proficiency testing for tests not performed in licensed laboratories. The bill is set to take effect on October 1, 2023, and is expected to generate additional revenue for the General Fund due to increased license fees.

Statutes affected:
Raised Bill:
PH Joint Favorable Substitute:
File No. 587: