Bulletin 18-1

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AATB Pleased with Changes in Recently Released AHCA Regulation

Bulletin 18-1

January 30, 2018

For the past several years, AATB and various tissue banks have had conversations with the Florida Agency for Health Care Administration (AHCA) regarding updating their regulations related to tissue banks, eye banks and organ procurement organizations (namely, 59A).

To aid in that discussion, the AATB formed an ad hoc working group to work directly with AHCA on those revisions. The focus of the AATB’s ad hoc work group was to provide key technical assistance to the AHCA related to areas in which the AHCA regulations directly conflicted with either FDA regulations or AATB Standards.

On March 31, 2017, AATB attended an AHCA workshop in Tallahassee regarding 59A, and submitted an overview of the AATB’s concerns. On April 14, 2017, the AATB, along with other key interested parties, submitted more detailed comments to AHCA. The AATB ad hoc work group also participated in two additional AHCA hearings (on May 25, 2017 and July 25, 2017) and assisted the AATB in crafting a final letter to AHCA with proposed revisions.

In December 2017, AHCA released its final regulations for 59A (effective January 17, 2018) and incorporated many of the key recommendations from the AATB, including deleting restrictions related to Medical Directors, and clarifying donor screening with respect to hepatitis, pneumonia and HTLV, as well as collagen and immune complex disorders.

With respect to the requirement for HTLV testing specifically, the verbiage of 59A-1.005, (35), (a), 2 has been changed to include a clarification that the requirement applies only to viable, leucocyte-rich cells and tissues. Detailed information about the revisions to 59A in track-changes can be found here. The final version of the new regulations can be accessed on AHCA's website.

The AATB has been in contact with the AHCA and clarified that the perennial HTLV waiver for AATB-accredited tissue banks will no longer be required.