OPTN OPO Committee Spring 2012 Regional Meeting Update

OPTN OPO Committee Update The Committee is currently working on: Policy requirements for uncontrolled DCD (u-DCD) similar to the DCD Model Elements. Developing a survey that will be sent out soon. Policy 5 R-Value for shipping containers Clarifying label requirements OPO Scorecard Threshold MPSC review of DEQ site visits Imminent and Eligible Death Definitions Involvement in various joint working groups

OPTN Proposal to Require Documentation of Unique Identifiers Used for Tissue Typing Materials Public Comment Document – Page 131 OPO Committee Regional Meetings – Spring 2012

OPTN Problem Statement  Current policy allows for the use of two unique identifiers to label tissue typing specimens. One being the UNOS Donor ID (if available at the time) and One of the following three: donor date of birth, donor initials or locally assigned unique ID

OPTN Problem Statement However, there is no requirement that the identifiers used on the tissue typing specimen be entered into the donor record that is sent with the organ. UNOS has received complaints from transplant centers regarding the use of a unique identifier that has not been documented in the donor record, resulting in the transplant center’s inability to validate it.

OPTN Solution Insert policy language that clearly states that the Host OPO or living donor recovery center must document in the donor record all unique identifiers used to label tissue typing specimens.

OPTN Proposed Changes to Policy Each separate specimen container of tissue typing material must have a secure label with two unique identifiers, one being UNOS Donor I.D., and one of the following three: donor date of birth, donor initials or locally assigned unique ID, (donor ABO is not considered a unique identifier). Additionally each specimen should be labeled with Donor ABO, date and time the sample was procured and the type of tissue. In the preliminary evaluation of a donor, if the UNOS ID or ABO is not available, it is permissible to use a locally assigned unique ID and one other identifier for the transportation of initial screening specimens. The Host OPO must document in the donor record all unique identifiers used to label tissue typing specimens.

OPTN Proposed Changes to Policy Each separate specimen container of tissue typing material must have a secure label with two unique identifiers, one being UNOS Donor I.D., and one of the following three: donor date of birth, donor initials or locally assigned unique I.D., (donor ABO is not considered a unique identifier). Additionally each specimen should be labeled with Donor ABO and subtyping (when used to determine transplant compatibility, date and time the sample was procured and the type of tissue. In the preliminary evaluation of a donor, if the UNOS I.D. or ABO is not available, it is permissible to use a locally assigned unique I.D. and one other identifier for the transportation of initial screening specimens. The living donor recovery center must document in the donor record all unique identifiers used to label tissue typing specimens.

OPTN Questions?

OPTN Attachment III to Appendix B of the OPTN Bylaws DCD Model Elements Public Comment Document – Page 135 OPO Committee Regional Meetings – Spring 2012

OPTN Background  Two years ago the Organ Procurement Organization (OPO) Committee was tasked with reviewing the DCD Bylaw to ensure consistency with current practice.  Policies were reviewed and found to be acceptable, however, the Committee agreed that the DCD Model Elements needed to be revised, updated and clarified.  The Committees rewrote the bylaws with the assistance of the UNOS Bylaws expert.

OPTN Update  This proposal was distributed for public comment during the March- June 2011 public comment period.  Several letters were received last fall requesting to reopen the public comment period for this proposal.

OPTN Update  The Executive Committee sent the proposal back to the OPO Committee for consideration of the comments received and revision of the proposal (if necessary) prior to sending it back out for public comment. The concerns raised in the letters are addressed in the proposal.

OPTN Main focus of the proposal remains the same  The proposed changes to the Donation after Cardiac Death (DCD) Model Elements will update and clarify language regarding DCD.  The changes update the bylaws so they will be current with accepted practice.  Consent/Authorization ― added the term “authorization” as it is the current accepted terminology.

OPTN Main focus of the proposal remains the same  The terms “Model Elements” were changed to “Requirements” as they are indeed required.  The terms “Donation after Cardiac Death” were changed to “Donation after Circulatory Death” to accurately reflect the definition of death determined by cardio-pulmonary criteria.

OPTN Main focus of the proposal remains the same  Two sections were added that mirror CMS requirements: OPOs must have a written agreement with hospitals participating in DCD and OPOs and transplant centers shall establish protocols that define the roles and responsibilities of the OPO and transplant center.

OPTN Key Changes from the Original Proposal Removed all examples from the proposal including:  References to specific diseases or conditions (e.g. end-stage musculoskeletal disease, pulmonary disease or upper spinal cord injury)  References to procedures or drug administration (e.g. heparin, regitine, femoral line placement, lymph node excision, ECMO, and bronchoscopy) to prepare the patient for DCD organ recovery.

OPTN Questions?