Our lab is an extension of our medical practice. We only process cells in ISO-5 hoods (biologic safety cabinets) and these hoods are located in a lab with particle counts consistent with ISO-6.
We use nationally known lab accreditation companies. We periodically audit the lab and make any changes recommended by auditor.
Colorado has no tissue bank licensure. However, recently New York state asserted that we needed a New York tissue banking license to treat NY patients. While we disagreed with the general assertion that NY can regulate medical activities in Colorado, we did apply for such a license and did receive a license, which can be seen here.