Comments

UAMS Medical Center | 04/26/2024

After evaluating the proposed addition of a code of conduct for OPTN volunteers and the addition of new bylaws, we need clarification on certain issues before determining a level of support. It is important to note that while we fully support the creation of a safe space for concerns to be addressed without fear of retaliation, we also respect the OPTN directors/committee members and seek clarification to ensure fair and just processes if accusations occur. First, we would like to see clarification regarding public statements as a director/committee member and their relation to the OPTN. What is the expectation on how to clarify the statement(s) are not related to the OPTN but are that of an individual? What statements require specific OPTN approval and what would be allowed without approval? The concern is that if directors/committee members cannot speak on certain topics without fear of code of conduct violations, important issues will go without being addressed and ultimately harm the transplant population. Second, we would like clarification on how accusations regarding a member will be handled. The 7-day response in some cases could be problematic, would there be exceptions to this? What is the expected response within this timeframe and what will the process look like after this initial response? While we understand that this cannot be prevented with an anonymous reporting system, we believe that a section should be added regarding complaints made that are determined to be false or not made in good faith. The directors/committee members should be able to defend themselves during the process and have an outline for how to do so. We would also like to see the specific duties that the compliance officer would be required to perform and how this person will be selected. Finally, we would like to see more of a focus on the whistleblower protection portion. We would like to see this portion addressed earlier in the document and made more of a priority versus being buried within other information.

Anonymous | 04/26/2024

Strongly Support

Glen Kelley | 04/25/2024

I am in favor of these initiatives. I would like to see and update to the section pertaining to the use of OPTN titles. As I understand, the current proposal includes the use of an OPTN position or title in conjunction with an article published in a scientific or professional journal if OPTN-approved disclaimer is used.

I strongly believe that this should also extend to patient community education. An example where this is useful is educating these communities during public comment periods for proposed policies. There are other opportunities beyond public comment to also educate the patient communities about the function of the OPTN too.

Rebeca Baranoff | 04/25/2024

1. I have concerns about these statement from the proposal :

"This role will ideally be filled by a current Director in good standing with human resources or personnel management experience."

I think it would be best if a person who has served as a compliance officer or who has extensive experience with compliance issues within a large company in the US would make a better choice for a Compliance officer (especially in the first two years of this new policy). Having experience in HR doesn't necessarily mean they have experience in Compliance.

"The Compliance Officer will serve a term of at least one year and
will be responsible for reviewing and responding to all reported violations of the OPTN Code of Conduct.'

The length of the term for the compliance officer should be at least two years and this needs to be clearly stated within the policy.


2. The details of the Code of Conduct Provisions (Duty of Care, Duty of Loyalty and Duty to ensure Compliance) need to be spelled out within the policy. They are not listed here but were discussed at the Webinar on April 25, 2024.

3. Having an attendance requirement for volunteers feels like an insult.
Perhaps there needs to be a policy, as part of the code of conduct, that allows the Chair or Co-Chair of the Committee in which the delinquent volunteer is part of, the ability to remove said volunteer after a determined number of attempts to speak with the volunteer and unsuccessfully determine the reason for delinquency, and then removing that volunteer from their duties with OPTN. This decision should be written and sent via US mail to the removed volunteer and the letter maintained with the Board of OPTN.

Steve Weitzen | 04/24/2024

Codes of Conduct can be important for an organization. However, they must be drafted for the benefit of the particular organization. I have questions and comments concerning the draft Code that has been presented, as follows (more specific comments can be provided once clarification is made concerning the questions/comments below):

1. With respect to Code of Conduct violations, I do not appear to see a method by which the person accused of the violation has a right to defend themselves – other than responding within seven days (Section 2.7). Perhaps I have missed it. If it is not present, it should be inserted, and there should be mention of a hearing or some way to interact with those making an allegation. At times, companies may NOT have such a process within their Code because all violations of company rules are handled pursuant to a separate set of due process rules, such as those set forth in a company human resources manual. However, no such manual would exist for OPTN. Perhaps that is the reason I cannot find a due process provision. Such a provision needs to be inserted for fairness.

2. I am curious/concerned about Sections 2.9 and 7.9 involving public statements by Directors and Committee members. Now, quite honestly, I do not know what is meant by these provisions. Can a Director/Committee member make a public statement on a topic related to OPTN activity if such person does NOT claim the statement is authorized by the OPTN? Or is such a person not permitted to make any such statement at all while a Director/Committee member?

If such person is permitted to make such statements then each of Sections 2.9 and 7.9 should make that clear. I have read other codes of conduct that clearly state words to the effect that “effected persons may speak publicly about matters of public concern, and that nothing with the Code is intended to or shall be construed to interfere with or limit the legal rights of effected persons.”(Note that this is not intended as a quotation.) Such clarification should also make it clear that just because someone is known to be a Director or Committee member should not be a cause for punishment under the Code unless such person specifically states that they are speaking on behalf of OPTN.

If the Code is intended to exclude such persons from speaking freely in public/private even if not stating that the person is speaking on behalf of OPTN, then not only would it be, in my mind, inappropriate, but it would also be unworkable. First for “unworkable” – many Directors/Committee members are members of other organizations related to organ transplantation, and many have significant roles within those groups. These people could not act within these groups if Sections 2.9 and 7.9 are interpreted to never allow them to speak without OPTN consent.

As for “inappropriate”, we all know that OPTN is comprised of volunteers – many of whom have full-time jobs and many others are older/not physically able to work extensively on matters related to OPTN. Therefore, there is not enough time or energy to accomplish all that is needed to be done. If we do not allow Directors/Committee members to speak on topics of concern without fear of Code violations, we will not be able to progress on topics that OPTN volunteers do not have the time or energy to act upon. In addition, if we do not allow such persons to speak on topics that may not be of interest to the leaders of OPTN, then ideas which could advance transplantation may be left undone, which could lead to harm to those in need.

3. The Proposal (on page 4) states that the whistleblower provisions were NOT intended to deal with differences of opinion and viewpoint but were only related to ethics violations, suspected violations of law such as complaints of discrimination or suspected fraud or suspected violation of any regulation governing the operations of OPTN. We all have seen good faith disagreements within the workings of the world of transplantation, UNOS and OPTN, especially during the last few years. If people are fearful to raise legitimate opinions, this could lead to fewer innovations, and we all know that we need MORE innovations to advance the cause of organ donation – not fewer. I strongly encourage that such form of retaliation be added to the whistleblower rules.

4. Section 2.7 requires review of the Code at least once every three years. Especially since this Code is new and there is so much change ongoing with OPTN currently, I encourage that the Code be reviewed every year.

5. In the Appendix, under “Duty of Care”, reference is made to following the OPTN Social Media Guidelines. Reference should be made to where such Guidelines can be found

6. In reviewing the Code, I noticed several typos/grammatical errors. I do not wish to be picky, but the Code should be thoroughly reviewed and those errors should be corrected.

In summary, a Code can be a good idea, but this draft Code has significant flaws and needs to be revised before adoption.

Jennifer Lau | 04/24/2024

It is in my personal and professional opinion that implementing policies which prioritize professionalism, integrity, and ethical conduct within any organization, especially one as critical as the transplant community, is undoubtedly overdue. Ensuring a safe space for patients, caregivers, and families to voice their concerns without fear of retaliation is essential for fostering trust and transparency within the community. It is heartening to see efforts being made to protect those who volunteer their time and energy to support such a vital cause. This will not only empower individuals to speak up but also strengthen the overall integrity of the organization and its practices.

Molly McCarthy | 04/18/2024

How would this serve patients and save lives? It wouldn't. All this would do is squash critical feedback AND protect the OPTN and federal contractor from being exposed for their shortfalls, especially when the escalation path for whistle blowers to report violations lands with the individual who has been called out as a key source of retaliation. No thank you - the entire purpose of this is protect this monopolistic org and rob patients of our voice.

Rebecca Baranoff | 04/18/2024

I think the idea of establishing a Code of Conduct makes sense. We are coming together from many different professions to ensure the safety and efficiency of a very complex process and we should be held responsible for our participation and hold up the ethics and conduct of the OPTN while we serve. Most of the individuals that participate in committees for OPTN work are in the medical profession but not everyone does. And this way there is a standard for all that are volunteering.

Honestly, I was surprised when I joined the DAC that there was not already training for a code of Conduct.

Anonymous | 04/17/2024

This proposal is yet another attempt on the part of the OPTN to stifle any form of checks and balances. This "Code of Conduct" effectively penalizes any Committee member from making any comments that can be deemed negative or defamatory to the OPTN or its committees. The fact that I am providing this feedback anonymously shows how much I repose in the OPTN's claim that retaliation is unlawful and prohibited. This is just another mechanism for the OPTN to completely strangle any negative feedback. The proposals that are being put forth by the OPTN continue to impede the growth of organ donation and transplantation in the United States. The leadership continue to push through proposals in a roughshod manner without any weight given to the opinions of actual front-line transplantation professionals and patients. All of this is at a time of extreme scrutiny (that is long-overdue). Specifically, the Membership and Professionals Standards Committee seems to be committed to penalizing transplant centers for truly inane and arcane reasons - always with punitive intent. Meanwhile, the MPSC members' centers seem to be miraculously immune from any such scrutiny - despite obvious known sub-standard practices and outcomes. Instead of putting forth proposals that will further stifle any open discussions of problems that are endemic in the OPTN's operations - the OPTN and its Committees should be looking to embrace transparency. This organization, rightly so, deserves to be disbanded and dissolved in order to allow other organizations that will be better suited to serving all of the patients that are desperately waiting for organs.

Simon Horslen | 04/17/2024

Fully support proposal.

Riki Graves | 04/17/2024

I support the establishment of Code of Conduct and Whistleblower Protection bylaws. When someone is a member of an OPTN Board or Committee, it is imperative that they act in a professional manner and represent the entire community, not just their personal interests.

George Surratt | 04/17/2024

This addition should make expectations clear, align with common and best practices, and create an even greater environment of fairness and safety to attract the best and brightest to continue the hard work of ensuring efficient increases in transplant.