Bulletin 19-6

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Changes to AATB Standards

The Board of Governors acted on recommendation from the Standards Committee and approved changes to the 14th Edition (2016) of AATB's Standards for Tissue Banking and the 2nd Edition of the AATB Standards for Non-Transplant Anatomical Donation (NTAD).

Unless specifically announced as “URGENT”, all changes have a fixed 6-month implementation period. This announcement requires your attention to review and potentially update your Standard Operating Procedures Manual (SOPM) and educate staff.

Please be advised that the changes to Standards published in Bulletin #19-1 (published January 31, 2019) go into effect today, July 31, 2019, with the exception of those changes extended via Bulletin #19-5 (published July 9, 2019).

A separate email will be sent to all AATB members with the full PDF copies of the Standards and NT Standards incorporating the following changes.

Changes to the 14th Edition, AATB Standards for Tissue Banking

SECTION D AUTHORIZATION, INFORMED CONSENT, DONOR SCREENING, AND TISSUE RECOVERY, COLLECTION, AND ACQUISITION

D5.610 Delivery Environment The amendment of Section D clarifies expectations concerning delivery rooms. It allows the treatment of designated delivery rooms in specialized health care facilities as ORs in the context of Standard D5.610 Delivery Environment, i.e. no site evaluation is required if birth tissue (BT) is acquired via conventional vaginal delivery in a designated delivery room of a specialized health care facility.

Changes to the 2nd Edition, AATB Standards for Non-Transplant Anatomical Donation

The following changes reflect updates, technical edits, and amendments to the NT Standards, Sections B, D, E, F, G, J and K.

NT SECTION B GENERAL ORGANIZATIONAL REQUIREMENTS

NT-B1.500 Written Agreements/Contracts The amendment to NT-B1.500 removes "donor referral" as a service or activity requiring a written agreement between the NADO and the referral provider as donor referrals do not necessarily involve the performance of any donation activity. Therefore, a contract is not needed to simply receive a referral or refer a potential donor to a NADO. Contracts with Acquisition partners typically cover this aspect.

NT SECTION D DONOR REFERRAL, AUTHORIZATION, DONOR SCREENING and ACQUISITION

NT-D1.000 General Policies
Replacing “family”  with “authorizing person” in the provision designating a decision maker when the potential donor is not on the registry.

NT-D1.100 Monetary Compensation Replacing “acquisition” with “donation process” in the provision stating that donors or their families should not be required to pay any donation-related expenses.

NT-D2.000 Authorization
Removing "detailed relevant" from the requirement for NADOs to have specific policies and procedures.  

NT-D2.100 Requirements Adding a requirement for electronic or voice-recorded documents of gift/authorization to comply with all state laws.

NT-D2.200 Conditions Adding a requirement for a translator and certificate of proof if NADO does not have trained staff to speak the language of the authorizing person.

NT-D2.310 Document of Gift Adding verbiage considering that NT donation is not provided as an option in all states' driver’s licenses with some exceptions.

NT-D2.320 Document of Authorization Adding "recorded voice consent" as required information for a document of authorization.

NT-D2.330 Methods of Obtaining Authorization Adding verbiage to the requirements for a sampling plan in regard to a recorded authorization that the recording must match the content's intent to cover the core elements of an authorization instead of focusing on verbatim.

NT-D3.210 Physical Assessment Adding reference to the AATB NT-Guidance Document NADO Tissue Donor Physical Assessment Form.

NT-D3.220 Donor Risk Assessment Adding reference to the AATB NT-Guidance Document NADO Tissue Donor Risk Assessment and Suitability / Acceptability Assessment Form.

NT-D3.250 Infectious Disease Testing Removing "duplicate and triplicate testing" verbiage from the provision covering initial and confirmatory/final testing performed by labs on organ/tissue donors to reflect lab practices and the way results are reported.

NT-D3.300 Information Sharing Replacing "NTAD/NAM" with "tissue" in the requirement for sharing information between establishments receiving tissue from the same donor.

NT-D4.000 ACQUISITION OF NTAD

Removing the requirement for a "preparation within an appropriate time interval" as preparation may be indefinitely postponed if donor is properly stored during acquisition, and in reference to revised verbiage of NT-E2.000 Preparation.

NT-D4.530 Storage Equipment Adding "NAM"  to "NTAD" in the provision requiring regular maintenance, calibration and monitoring of freezers/refrigerators used for storing of NTAD/NAM according to written procedures.

NT SECTION E PREPARATION, TRACEABILITY, QUARANTINE and STORAGE

NT-E2.000 Preparation
Removing the requirement for an "preparation within an appropriate time interval" as preparation may be indefinitely postponed if donor is properly stored during acquisition, and in reference to revised verbiage of NT-D4.000 Acquisition of NTAD. 

NT-E2.100 Environment Splitting item 6) in the section about required features of a preparation site to reflect the fact that OSHA does not approve devices for lifting and/or transporting NAMs.

NT-E2.320 Stock Rotation (Removed) The requirement for stock rotation is removed as the FIFO principle is only applicable to tissues intended for clinical use, but is not critical in the process of preparation for NAMs.

NT-E2.320 Containers Removing the verbiage pertaining to "toxic residues" produced by containers as this aspect is covered by IATA and dangerous goods regulations.

NT-E3.000 Preparation Methods
Removing the requirement for NAM preparation “in a timely manner” as it is applicable mostly to tissues intended for clinical use. If properly acquired, NAMs can be stored indefinitely.

NT SECTION F RELEASE and TRANSFER of NAM

NT-F1.110 Records for Review Adding verbiage to indicate that plasma dilution is evaluated only if applicable.

NT-F1.120 Infectious Disease Risk Review Adding verbiage pertaining to alternative explanation of RCDAD presence or test results as a prerequisite to NAM release, together with a consent obtained by the individual education or research requestor.

NT-F1.140 Interpretation of Infectious Disease Test Results Removing "duplicate and triplicate testing" verbiage from the provision covering initial and confirmatory/final testing performed by labs on organ/tissue donors to reflect lab practices and the way results are reported, and to match NT-D3.250 Infectious Disease Testing.

NT-F2.100 Release of NAM Adding a reference to NT-B2.221 pertaining to exceptional release and correcting an editing error.

NT SECTION G REQUEST for USE of NAM

NT-G1.100 Submission of Requests for NAM Adding an additional item 12) requirement for a signature and date to the items that must be contained in a written request for use of NAM.

NT-G1.200 Evaluation of Requests for NAM Adding a requirement for a date to be included in item 3) under the NAM Request Procedure.

NT SECTION J FINAL DISPOSITION

NT-J1.100 – Required Disposition Records Adding verbiage to the Required Disposition Record requirements, e.g. acceptable final disposition, compliance with local law in regard to the return of cremated remains to the authorizing person, determination of value of the temporary container under local law, and removing a requirement for using USPS registered mailing services as such mailing service is no longer available.

NT-J1.300 Disposition of Distributed NAM Adding a requirement for establishing a NADO procedure for the educator and/or researcher to provide written attestation that they maintain and be able to provide all disposition records of distributed NAMs.

NT SECTION K GENERAL OPERATIONS

NT-K1.200 Contents Adding a policy requirement for labeling of tissue and/or NAM specimens, handling or disposal of anatomical remains to match NT Section J, and removing the time limits for storage and preparation to match NT Section E.

NT-K3.600 Hazardous Waste Disposal Adding "anatomical remains" to the requirements pertaining to Hazardous Waste Disposal.

NT-K4.200 Designated Space Adding "anatomical remains" to item 8) about storage of medical waste, of the list of critical procedures to be performed only in designated areas.

All changes announced herein have a six-month implementation period starting on July 31, 2019, and shall be effective on January 31, 2020.

If you have any questions, please contact Dr. Roman Hitchev at hitchevr@aatb.org.