THE ASSOCIATION AT WORK
surface conditions including pterygium or trauma. EBAA’s comments request clarification on how to define the “main function” of the HCT/P, which shifts the focus from the function in the recipient to the function in the donor. The association shares the concerns of its transplantation partners that if finalized in the current form, many HCT/Ps will be considered more than minimally manipulated and, thus, subject to regulation beyond section 361 of the PHS and 21 C.F.R. Part 1271. To view EBAA’s comments on the guidance, click here.
Implementation Guidance for the Uniform Donor Risk Assessment Interview Forms Administering and completing the donor risk assessment interview (DRAI) is an essential safety element of donor screening and determining a deceased donor’s eligibility. EBAA has worked with the American Association of Tissue Banks (AATB) and the Association of Organ Procurement Organizations (AOPO) to develop Uniform Donor Risk Assessment Interview (DRAI) forms to promote uniformity in donor screening activities and optimize donation outcomes. The three transplant organizations developed a joint guidance document for implementation which outlines expectations and contains useful descriptions and references for the person administering any of the Uniform Donor Risk Assessment Interview (DRAI) forms (i.e., Donor >12 years old, Child Donor ≤12 years old, and Birth Mother). The EBAA MAB approved this guidance document that is now included in the EBAA Technical Procedures Manual. The three organizations presented on this information to EBAA members via webinar in August 2014.
10
Accreditation Board Develops New Accreditation Status Guidelines
ACBTSA provides advice to the Secretary and to the Assistant Secretary for Health. One of the recommendations ACBTSA made was to:
The Accreditation Board (AB) approved a new scoring method for accreditation status recommendations, using a weight-based, tiered system. The AB will pilot updated forms and scoring methods during the upcoming Fall 2015 accreditation cycle.
Establish use of ISBT 128 code in electronically-readable format as a universal standard for mandatory implementation of unique donation identifiers for all human tissue products.
During a September 6, 2014, fly-in, the Accreditation Status Subcommittee reviewed the accreditation forms and developed a 3-tiered system of question “significance” for each question on the PIQ/SIQ: Potential Threat (PT); Significant Observation (SO); or Nonconformance. The subcommittee then proposed new guidelines for status recommendations based on how many citations of each “tier” a bank can receive. The proposed scoring system would remain a guideline, and the AB will continue to have flexibility in voting for a bank’s accreditation status.
EBAA Advises HHS on Tissue Tracking and Traceability The U.S. Department of Health and Human Services (HHS) Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) met in April to discuss improving tissue safety through better tracking and traceability from donation to clinical use. Marian Macsai, MD, who represents EBAA on this committee, presented on the EBAA Medical Standards regarding tracking and traceability, recipient follow-up, adverse reaction reporting, and the decision to move to full implementation of ISBT 128 nomenclature, coding and labeling.
EBAA Implements ISBT 128 The EBAA MAB voted in October to incorporate the implementation dates and requirements for ISBT 128 nomenclature, product codes and bar code labeling into the EBAA Medical Standards. EBAA and ICCBBA have collaborated on the developing education and tools to assist eye banks with this implementation. A webinar entitled ISBT 128: All Eyes on Implementation was presented in December 2014, and EBAA and ICCBBA created a Registration FAQs – Ocular Tissue Establishments to answer common questions eye bankers may have about registration. EBAA has worked with ICCBBA and the Eye Bank Technical Advisory Group (EBTAG) members to make new product codes and attributes for longterm preserved tissues, and assure a smooth transition for member eye banks. EBAA sent an alert to clarify the ocular tissue labeling when multiple eye banks are involved. The Implementation Guide: Use of ISBT 128 in North American Eye Banks was released in May 2015, and the MAB formally approved it. This guidance was added as an addendum to the EBAA Procedures Manual.