Correction, state and federal regulators are deeply involved; hence the license to operate in a state and FDA, CLIA, AABB and other accreditations of compliance. The CBAI workers are licensed to perform specific lab functions and the MDs that oversee the daily operation are also licensed by the state.
The FDA regulates the lab and it must follow an accreditation process to perform a process.
You are correct the cord blood banking industry and hospitals are both heavily regulated. In this instance a hospital after delivery transfers that responsibility to another healthcare institution called CBAI to process the tissue and blood. The contract detailing consent is key. Absent a contract detailing consent CBAI gets nothing and the hospital carries the ball forward. Thx
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