0184 revision list

Summary of Changes

OPTN Application for Membership Forms

The forms submitted here have been re-formatted in order to make them simpler for the applicants to complete and for UNOS to convert when electronic submission of the applications is an option in the future. Questions that are very general in nature in the current forms have been further refined, where possible, from open-ended responses to yes/no or check boxes, and wording has been revised for clarity as to what information should be provided.

In addition to the formatting improvements, there are several changes to the forms:

Organ Specific Application

Part 1:

The organ application checklist has been expanded to include living donor kidney and liver.

• Section B: Donation after Cardiac Death (DCD) protocols section has been added.

Part 2:

Section A: The organ application checklist has been expanded to include living donor kidney and liver.

Section B: Added questions 1b, c, d, e; and 2

Section C: Human Resources has been reformatted and updated to reflect Bylaws to obtain information on specific health professionals for the following institutional members:

Added Question 3 about Clinical Transplant Coordinators.

Reconfigured Question 4 about Financial Coordinator

Added Question 5 about Clinical Transplant Pharmacist.

Reconfigured Question 7 for Anesthesiology Commitment.

Question 8 Staffing Resources – Planning related questions has added a chart.

Question 9 Program Coverage Plan-Program coverage was previous addressed as an open ended discussion question.

Revised Question 10: Administration. Expanded general discussion question to obtain more specific information.

Section D: Protocols/Methods/Procedures

Added Questions 1 and 2 – Patient/Candidate Management & Outpatient Care.

Question 3: Patient Selection Criteria -Expansion of question in current forms.

Question 4: Expands on questions asked under the surgeon/physician sections.

Section E: Business/Implementation Plan. Format change. Current forms asked for a plan. New version asks that center attest that they have plans in place that cover minimally the listed areas. Some of the elements of the plan that programs address in the current version are now incorporated into other questions in the forms.

Part F: Added questions 1 and 2 on organ procurement arrangements.

Part 3- This section has been reformatted as follows:

• Check boxes have been provided at the beginning of the surgeon/physician questions to help remind the applicants of the supporting documents that are required.

• Questions have been added to the kidney and liver applications for programs that are applying to perform living donor transplants. Supported by bylaws. The living donor liver application was previously a separate form but the new format allowed us to include it as a component of the liver application. The living donor kidney questions are all new.

• Forms now call for center to delineate which surgeons/physicians meet bylaw definitions of “additional”.

Part 4/5: Certificate of Investigation has been added in response to Bylaw changes requiring institutions to certify that all the physicians and surgeons participating in the program have been investigated for prior transgressions.

Sample logs for the surgeons and physicians have been included as a part of each organ specific form. Presently they are a separate component.

In-House and Independent OPO Applications

Applications have been updated to include a section on Donation after Cardiac Death protocols.

In-house and Independent Histocompatibility Laboratory Application

Added reference to the College of American Pathologists (CAP).