The article in Quartz
https://qz.com/914490/theres-a-complete ... man-heads/
discusses the AATB, but it leaves out some of the nuances. The AATB started out strictly to regulate the industry that handles tissue for transplantation into living patients. Obviously, that industry must be heavily regulated, and the high costs are passed on to the recipient patients and to insurance companies. Our industry is completely different, and it wouldn't be appropriate to use the AATB standards. The AATB did "adapt" their existing standards for non-transplant organizations, but the adaptation was inadequate. The standards are extremely high. Examples of requirements:
-A detailed SOP with 15 sections.
-Governing body for oversight.
-Contracts with other organizations and audits of those facilities.
-Multiple staff with clear separation of duties, including director, physician advisor, quality assurance unit, donation coordinator, and technicians.
-Rooms with dedicated purposes and no dual purpose, and independent ventilation to outside. This would disallow many configurations. For example: refrigerator in separate room, two tables in one room, or shared heating/cooling furnace.
-Donor physical assessment, medical information, acceptability assessment, witness, etc.
-Quality assurance audits, equipment quality testing, etc.
-Accreditation inspection from AATB.
Keep in mind that a typical non-transplant organization is a single person operation with a low tech space. Obviously, the requirements above are excessive. They might be achievable if the organization is very large, but they exclude smaller organizations. There are only seven organizations who are accredited, and this is because those seven organizations are the only ones large enough to meet the standards. If states start requiring AATB accreditation, it will simply push small operations out of business and will not solve any actual problems. The Quartz article made two very good points:
1. The thorniest questions in non-transplant donation are of ethics, not public health.
2. There are clear economic motivations for an established company to pursue more regulation, because higher barriers to entry mean less competition.
We do support carefully implemented legislation that addresses the ethical issues surrounding body donation. We do not, however, support legislation that deals with the physical facility or how the company is run, especially when those rules are clearly designed to exclude small organizations.
American Association of Tissue Banks (AATB)
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