Comments

Anonymous | 05/17/2024

As a past 2 term OPTN Board member, I generally support this proposal as a component of good corporate governance. I am also posting this comment anonymously which should speak to the need.

The proposal does not adequately define what the process will be for reviewing and evaluating complaints or who needs to approve or vote to suspend voting privileges or board service of a director alleged to have violated these standards (the bylaws only deal with removal of a director). It is unclear what protections an accused board member has under this proposal and that ought to be included. The adjudication of potential violations can be very subjective if the complaint being evaluated is something related to the types of things listed in the “duty of care” (for example “value diversity in thought and opinion” and “leave personal biases out of OPTN discussions”).

This leads to a bigger issue with the proposal which is that “duty of care” is a legal term of art that, together with the duty of loyalty defines the fiduciary responsibilities of a board member to the organization. Duty of care is defined in the law to mean an obligation of board members to apply themselves “with such care as a careful and prudent individual would use in similar situations” for the benefit of serving the organization. This is generally understood in the law to mean things like attendance, reading materials, engaging in decision-making. But as defined in this proposal “duty of care” goes well beyond the legal concept of responsibility to the organization to include expectations of behavior to each other in the community. These respectful conduct expectations do not belong under “duty of care” but rather under a separate category to avoid confusing the fiduciary standards of board members that have legal implications for the OPTN. Consider a structure with the duty of care and loyalty as legal compliance responsibilities of Board members and a separate code of conduct related to behavior expectations for board members. Complaints about violations of the code of conduct should run a different path (e.g. HR) than corporate compliance complaints (e.g. legal) which should be focused on alleged violations of legal duties, conflicts of interest or other laws and regulations and should also be covered by the whistleblower protections. The corporate compliance officer should be a professional with training and experience in compliance and not a board member to ensure independence, expertise and continuity over time.

It is important for the community to understand that the law requires board members of an organization to act in the best interest of the organization (duty of care and loyalty). These protections are longstanding legal principles to ensure good governance and corporate accountability at the board level. This does not preclude critical thinking or dissent but it does require a mindset that board members are legally responsible to apply business judgement and make decisions in furtherance of the organization's interests as aligned with its mission and goals.

charles bearden | 05/17/2024

I strongly oppose this proposal as written. I base this personal and professional opinion on first hand experience as a double board certified Surgical Physician Associate who has practiced for 52 years. I am currently the longest serving organ recovery transplant coordinator in the nation in my 47th year. I recently served on the National Academies of Sciences Engineering and Medicine Consensus Study Committee that published "Realizing the Promise of Equity in the Organ Transplantation System." I have been a member of the Advisory Board of Organize.org for 10 years. I want to provide feedback and comment on behalf of organ donors and their families, front-line OPO professionals, and potential and actual transplant recipients and their families who I have cared for and served for the last five decades.
The recent Securing the U.S. Organ Procurement and Transplantation Network Act signed into law by President Biden, passed in an unprecedented unanimous, bicameral, and bipartisan Congressional legislative agreement. Its intent is crystal clear and succinct. The 40 year old UNOS contractor monopoly must end and the OPTN Board must be independent. Currently the ability for an independent board to exclusively support and represent patients is seriously stymied when the UNOS Board and the OPTN Board are exactly the same people. It is an obvious conflict of interest to have a network that puts the UNOS organization and its behind closed doors old-boy culture ahead of patients and providers and it has, sadly, gone on far too long.
UNOS is perfectly aware that HRSA has the contract soliciting bids for a new non-profit entity to administer and support the new "independent" OPTN Board. UNOS and the OPTN continue to be the same organization that has resisted and consistently fought the reform, transparency, accountability and the modernization so desperately needed. The CMS Final Rule and the Securing the U.S. OPTN Network Act are a result of patient advocacy and hard, persistent work for the last decade.
Therefore I find it particularly distressing and distasteful that UNOS would, at the last minute make this desperate final attempt to silence the voices that need to be heard at the table. We are called external stakeholders yet patients, their families and advocates need to be internal stakeholders, free to voice their opinions without fear of retribution by UNOS.
I have carefully read their proposed Code of Conduct and Whistleblowers Protection and all of the public comments made by interested and mostly concerned individuals. All of us responding should be grateful for the opportunity to do so provided to us by HRSA. I can tell you from experience that they do read and give proper consideration to all comments pro or con.
I will not belabor all the valid criticisms and concerns already voiced consistently by "external" stakeholders in these public comments. The issues are many but consistently similar. The Compliance Officer being a member of the Board is an obvious conflict of interest. The combining of a code of conduct with a required OPTN "duty of loyalty" pledge in the whistleblower policy is a conflict of interest. We should be entirely patient centric and have a "duty to care" patient pledge first. Having a Compliance Officer for enforcing the OPTN by policy but not having a full time Ombudsman to protect those who are brave enough to come forward and speak up, is a conflict of interest.
The policies as written would effectively be a gag order for any OPTN member. It would allow concerned individuals who share their opinions on social media to be cited by a Compliance Officer and there would be no due process, no time to adequately defend yourself or to have any choice but to abide by their decisions. It most certainly going to have a chilling effect on discourse and reporting problems or concerns. We are desperately trying to shine the light of transparency on the OPTN and this would be entirely antithetical to our efforts to get to the data and input needed for accountability, and have frank and open discussions without the fear of retaliation.
This proposal does not consider any of the standard Whistleblower protections that are enforced policy in the laws of the Federal Government and their contractors, the IRS and 45 states. (see 18 USC 1513 and 31 USC 3729). It is, frankly toothless, vague and self serving and, along with this code of conduct, is pathognomonic of the problematic UNOS monopoly and culture that puts its own interests ahead of our patients.
We need UNOS and the new OPTN to obey the law and its intent. UNOS writing this policy and bylaws change at this last minute is an affront to transplant patients and the professionals who care for them and sadly is embarrassingly unprofessional but not unexpected. The proposal should at least be tabled but ideally it should be dismissed with prejudice by HRSA. The new, truly independent by law, OPTN Board that is coming is the only body that should formulate and enforce this new and hopefully better Code of Conduct and Whistleblower Protections not UNOS.
The NASEM report made it clear in the preface. "As requested in the study charge, the committee also considered the OPTN policy-making process and opportunities for improving it. While the steps in the general policy-making process are well documented, the dynamics of the OPTN committee interactions and the true impact on final policies was not always clear. The OPTN is not alone in its efforts to work with a broad range of stakeholders to craft policies to complicated and contentious issues in health care and policy-making process for organ procurement, allocation, and distribution and should be informedly the expertise and experience of other entities."
Please let the "other entities", the patients and advocates, have a free voice in a collaborative environment. We are all stakeholders. Time to get rid of the "internal" or "external" stakeholder monikers that do us all a disservice. We have to have diversity, inclusion, access, transparency, accountability to achieve equity in our system....and the ability to criticize UNOS and the system pro re nata.

Gift of Life Michigan | 05/17/2024

We appreciate and support the work by the OPTN Executive Committee’s efforts to incorporate a roadmap for reporting possible breaches of the codes and other matters important to the OPTN.

We note that the proposal suggests that all reports are to be made in writing. Considering the wide array of people who could potentially need to report something, we would encourage other avenues of reporting, especially electronically.

We would also urge the Board to engage one or more independent third-party providers to receive reports and manage communication with reporters. This could enhance the Board’s efforts to provide a platform for reporting while avoiding any appearance of screening or rebuke for the complainant. Since the Code would apply to the Board and its functions, it puts to Board in a potentially awkward situation to have a member of that Board serve as its compliance officer. We understand the proposed rationale, but we encourage to Board to seriously consider all avenues to avoid any perceived conflicts of interest or that the Code of Conduct was created for appearance’s sake only.

The proposed Code of Conduct appears in keeping with standard expectations of those wishing to serve on a Board, and we support its formalization.

Infinite Legacy | 05/17/2024

Infinite Legacy supports amending the OPTN bylaws to establish a code of conduct and to provide for whistleblower protections. Setting forth conduct expectations of volunteers is important, as is clearly establishing the authorization parameters for responding to media inquiries on behalf of the OPTN. Whistleblower protections should apply to anyone raising concerns, including OPTN volunteers. That said, it remains to be seen whether the OPTN itself can adequately and appropriately investigate and enforce a code of conduct violation by one of its own members. To that end, there are very few specific disciplinary actions or other remedies available for violations, which allows for a high degree of discretion when addressing violations. The OPTN may want to consider offering examples of specific disciplinary remedies to avoid claims of bias in its implementation. Finally, the policy should be expressly amended to prohibit OPTN Directors, Committee members, and volunteers from using confidential information to the advantage of their member organizations, in addition to the current prohibition on use of confidential information for personal gain.

Association of Organ Procurement Organizations | 05/17/2024

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View attachment from Association of Organ Procurement Organizations

Jane Zill | 05/17/2024

The following public comment represents my personal views. They should not be construed to represent the views of the Organ Procurement and Transplantation Network or those of the United Network for Organ Sharing.

Jane Zill, L.I.C.S.W.
Living Organ Donor, 1991
Living Donor Committee (2007) and Living Donor Data Task Force (2008)

Where is UNOS in the creation of the proposal?

The Securing the Organ Procurement and Transplantation Act (2023) is meant to “improve the management of the U.S. organ donation system by breaking up the contract for the OPTN and encouraging participation from competent and transparent contractors.”

Consequently, UNOS will not continue to be the sole contractor for the OPTN. However, during the transition period to new contractors, UNOS maintains its leadership role of the OPTN. Why? Because the Executive Director of UNOS and the OPTN are the same person, and she’s also a member of the Executive Committee, the sponsor of this proposal.

Although the OPTN is mentioned throughout, there is no mention of UNOS. Why?

Note that the National Kidney Foundation expressed concern in March:

”Reports that UNOS is planning to establish a subsidiary to house the OPTN board are deeply alarming. Such a move would fly in the face of congressional intent, undermine public confidence in the independence of the OPTN Board, and diminish any faith or goodwill that UNOS is operating in the best interest of the patients it purports to serve.”
If true, UNOS is intent on continuing to control the OPTN despite losing its role as sole contractor. Consequently, adoption of this proposal should be delayed until the concerns expressed by the National Kidney Foundation are fully investigated, transparently reported, and the proposal is amended to satisfy congressional intent.
Why the emphasis on loyalty to the OPTN and volunteer “conflict of interest”?

The OPTN exists to serve patients; however, the proposal claims to have no impact on select patient populations (or anyone else), which then leads to questions of why it’s needed, why now, who will it benefit, and who will it impact?

Inexplicably, it emphasizes loyalty to the OPTN, the only community of interest mentioned. Additionally, the new mandatory Code of Conduct (which will be embedded in its by-laws), includes strict provisions for volunteers to report any “conflicts-of-interest” with the OPTN -- not only their own, but those of others. Volunteers are also required to sign the Code of Conduct annually.

This is an egregious overreach as it (a) puts volunteers in an untenable position, (b) gives the impression that the actual intent is to intimidate volunteers, (c) and, roots out those who have a “conflict of interest,” potentially to gain advantage in a competitive process for government contracts by gleaning information from reported violations, which are mandated and must be made in writing.

The Code of Conduct also requires all volunteers to participate in any project that is assigned to them. Again, this does not reflect an organizational culture that is collaborative, supportive, or respectful.

Given these stipulations that apply to volunteers, they are an impacted group and should be named as such in the proposal, but they are not.

Many OPTN volunteers receive committee appointments in because of their roles in other organizations (e.g., NKR, NKF). Some of these organization may compete for an OPTN contract, creating a “conflict-of-interest.” Consequently, these organizations should also be listed as potentially impacted groups.

Why are HRSA representatives as ex-officio members required to sign the “Code of Conduct”?

This proposal has the very real potential to limit governmental oversight of organ donation and transplantation.

Is the actual intent of the proposal to bolster UNOS control of the OPTN and conduct surveillance on potentially new contractors, thereby undermining the Securing the Organ Procurement and Transplantation Act and sacrificing the public interest in service of “loyalty to the OPTN.”

As explained in the informational video, it will be required of all to sign and adhere to the Code of Conduct, which requires loyalty to the OPTN and disclosure of “conflict-of-interest.” This requirement will extend to HRSA representatives who are ex-officio committee members (by virtue of their role as employees of the Federal Government) whose primary role is to monitor the OPTN and its contractor.

Does the OPTN Executive Committee really believe it has the authority to require Federal employees who are assigned an oversight role of the OPTN, to sign a Code of Conduct that emphasizes loyalty to the OPTN?

Will HRSA representatives whose obligations are to the public be accused of having a “conflict-of-interest” when serving in the capacity as ex-officio members of OPTN committees?

Will the OPTN have the authority to refuse to allow the participation of HRSA representative based upon their oversight and monitoring role, interpreting their role as evidence of “conflict of interest?
What will happen if HRSA representatives refuse to sign the Code of Conduct? Will they be prevented from participating, significantly undermining government oversight?

By signing the Code of Conduct that emphasizes loyalty to the OPTN, will HRSA be unable to issue contracts to non-OPTN organizations?

When I was appointed to the Living Donor Committee as a public member, I thought my mission was to represent the public, not loyally serve UNOS/OPTN. However, I came to learn the UNOS/OPTN culture and its unwritten “rules of road” when I was severely admonished for sharing committee information with HRSA representatives, Ex-officio members of the committee, who were serving alongside me. The admonishment was delivered in a manner meant to intimidate me, which it did, as well as to limit the information HRSA representatives receive.

The November presidential election has many concerned about how the concentration of wealth and power is undermining our democracy. Does the OPTN, as we currently know it, exist primarily to perpetuate itself or to serve the public?

Whistleblowers serve an important public function as they reveal mismanagement or abuse by an authority relating to a government contract or grant, safety lapses in patient care, dangers to public health and safety, the manipulation of research findings, and violations of standards related to competition for a government contract or grant.

The OPTN’s conception of whistleblowers is aimed in service of itself. It uses volunteers like puppets, discourages sharing information with external regulators, and is preoccupied with member and volunteer loyalty, undermining the mission to improve the U.S. system of organ donation and transplantation.

Justin Wilkerson | 05/17/2024

I oppose this as written. The only issue I have with it is the key issue that this effort undertakes which is the terms outlined concerning the appointment and duties of the Compliance Officer. More to the point, I believe an appointed compliance officer who is a current sitting board member would be completely ineffective.

1: Having a Compliance Officer who monitors complaints against the board, contractor, or leadership who comes from the board and is a current serving member of the board seems like at worst a clear conflict of interest, and a best, poses a potential dilemma of pitting board members against each other in the effort to resolve a complaint or conflict against fellow members.

2: How effective would a Compliance Officer be who is a current sitting board member? Having one of these very important positions would be, should be, if done well, volunteer work enough for one person; how could one person effectively do both on volunteer time? Could a person read everything to keep step with regular OPTN policy development, work on various committees, attend board meetings, and evaluate, propose resolution to, and brief the President and Board on complex and sensitive complaints quarterly? Sounds like a steep hill to me.

3: Having a term of one year at a minimum seems like a potentially short amount of time to be effective in the position. A complex investigation could take months to resolve. I would want a Compliance Officer position to at least carry through board terms. An assignment of a year could be detrimental to effectively executing the duties of the position.

4: Part of what this Compliance Officer should be doing is advising the president and board from an independent perspective. How can this be done from within by a current board member appointed from within? This could be an awkward position to be in.

Proposal: The Compliance Officer should function more like an Inspector General. The appointment should be made outside the OPTN, perhaps appointed by HRSA. The person assigned should understand the organization well and probably should be a current or former board member or committee chair who, if currently sitting, resigns the position to be an independent Compliance Officer, or IG. The term should be a minimum of three years so that the person assigned has time become effective at the position. The independence of the position could make the Compliance Officer an effective advisor to the President and the Board and could take on the qualities of mentor, advising to prevent issues before they occur. If the position was done well, the compliance officer could be a real asset to OPTN leadership and board in independently reviewing and advising on complaints. This could easily be a full volunteer position.
With this added independence, I would support this proposal.

Society of Pediatric Liver Transplantation | 05/17/2024

The Society of Pediatric Liver Transplantation strongly supports the proposed changes to the OPTN bylaws to "Establish a Code of Conduct and Whistleblower Protection Bylaws" We feel it is important to both protect those serving as OPTN volunteers as well as provide a safe space for individuals to voice concern.

Organize & Federation of American Scientsts | 05/16/2024

OPTN Whistleblower Response

Submitted to the OPTN and also to HRSA leadership directly

Patients — both donors and recipients —and their families have suffered grievous harms due to the lack of sufficient standards, oversight, accountability, timely remediation, and transparency in response to problems identified by industry insiders, whistleblowers, and patient advocates.

The nation’s organ procurement and transplantation network (OPTN) has become unsafe, inequitable, and ineffective under the management of the United Network for Organ Sharing (UNOS), which has operated as the sole OPTN contractor since 1986. See the conclusion reached in a bipartisan report by the Senate Finance Committee in 2022: “From the top down, the U.S. transplant network is not working, putting Americans’ lives at risk.”

As Senator Chuck Grassley noted in a 2023 hearing, the Senate Finance Committee “has received credible allegations regarding the United Network for Organ Sharing…threatening whistleblowers including even patients and caregivers. Simply put, this is beyond unacceptable. These efforts appear to be part of an attempt to cover up failures and prevent competition for its government contract.”

The fact that the OPTN operated for almost 40 years without its own whistleblower policy, consistent with standard practice and law for nonprofit organizations and government contractors, ist itself is a damning indictment of both the management of UNOS as the OPTN contractor and of the OPTN board itself (which was composed of the exact set of individuals as the UNOS board until April 2024).

A robust whistleblower policy that goes above and beyond baseline expectations for nonprofits and federal government contractors is essential to ensure OPTN contractor and subcontractor employees know they will not be retaliated against if they come forward with good faith complaints of fraud, waste, abuse, harassment, discrimination, or other harmful or illegal activity.

That said, given the national significance of the OPTN as a public good, and its mission and responsibility to set policy affecting hundreds of thousands of the country’s most vulnerable patients, it is also critical to acknowledge that a robust whistleblower policy in and of itself is not sufficient to establish an open-door culture and responsive practice of accountability and rapid problem resolution, because the term “whistleblower” can in policy and in law have a narrow meaning related specifically to employees and contractor/subcontractor employees — a meaning too narrow to be appropriate for the reality of the OPTN’s multi-organization breadth, scope, and impact. In practice, many individuals across the country have direct, on-the-ground insight into potential problems or inappropriate or illegal activity regarding the OPTN. This includes not only OPTN Directors, OPTN committee members, or OPTN volunteers, but also the directors, officers, employees, and contractor employees of OPTN member organizations such as transplant hospitals, organ procurement organizations (OPOs), patients, families, doctors, and advocates, among others.

Therefore, both the OPTN and HRSA must acknowledge the statement put on record by Senator Grassley as well as the testimonies of numerous industry insiders and patient advocates, and put in place robust policies, processes, and communications to encourage any individual with knowledge of problems or wrongdoing related to the OPTN to bring forward concerns to either both the OPTN directly (when they are comfortable doing so and believe it appropriate), as well as to the federal government (HHS agencies, Members of Congress, and, as necessary, law enforcement). This requires clear and public processes for reporting of issues and complaints from any source and designated, accessible, and independent ombudspeople and community liaisons who are empowered to track, report, and respond to reported problems across the OPTN network in coordination with the OPTN Member and Professional Standards Committee (MPSC), and also to coordinate and cooperate with federal, state, and local law enforcement as necessary.

We urge HRSA and OPTN contractors to take a broadly inclusive stance to set a culture of accountability and response to reported problems regardless of who reports the issue, and to protect and not retaliate against anyone who “blow the whistle” in good faith. This requires both a broadly applicable and defined whistleblower policy that protects OPTN contractor and subcontractor employees and HRSA employees who report good-faith complaints and additional interventions, such as zero-tolerance policies for harassment, discrimination, and relation against anyone who reports OPTN problems or wrongdoing by HHS, its component agencies and employees, its contractors and subcontractors and their employees (and lobbyists); or anyone else in any way affiliated with the OPTN.

Additionally, given the interconnectedness of OPTN member organizations, especially OPTN-member transplant centers and OPOs, individuals who bring forward complaints via designated officials or the OPTN MPSC must not only be protected from retaliation from their own employer, but also from retaliation by HHS or HRSA employees, OPTN contractors, subcontractors, members, and other institutions in the field. (Here, is it worth noting that 25 years ago, Forbes labeled UNOS, the OPTN contractor, a “cartel”, highlighting the chilling collusion within the organ procurement and transplantation industry, carrying deadly effects to patients.)

Related, we also urge HRSA to work closely with the Centers for Medicare and Medicaid Services (CMS) to actively encourage stakeholders to report problems and abuses directly to the federal government, rather than only to the OPTN. It is well-known in the industry that UNOS has retaliated against stakeholders for filing complaints with the MPSC regarding OPOs or transplant centers. And while that retaliatory behavior is clearly inexcusable, it also begs a larger question regarding why the federal government has continued to allow this industry to oversee itself in the first place. Given that CMS has regulatory oversight authorities over OPOs and transplant centers, it should take a more active role in encouraging whistleblowers and other stakeholders to bring complaints directly to them, rather than to an external contractor, which inherently deconflicts this process more than any whistleblower protection policy ever could.

With that in mind, below please find comments related to direct issues posed during this comment period. We also have reviewed the comments provided by the OPTN Patient Affairs Committee, share their concerns, and support their suggestions.

Jennifer Erickson
Senior Fellow, Federation of American Scientists

Greg Segal
CEO, Organize

Laws and Established Practices for Whistleblower Policies and Procedures

Related to Nonprofit Organizations

Given that OPTN policies are set by a Board of Directors that, consistent with the OPTN final rule, sits within a 501(c)3 nonprofit organization, the laws for nonprofit whistleblower protections should be looked to as the minimum floor for establishing any minimally viable whistleblower policy for the OPTN. Indeed, the OPTN Board of Directors should look to best-in-class nonprofit practices that go beyond the minimum protections required by law, given that OPTN is operated nationally for the public good in the interest of patients and their families — anything less than a gold-standard policy would be to the detriment of those patients and families.

Dozens of Federal laws (see, for example, 18 USC § 1513 and 31 USC § 3729) and State laws regarding whistleblower practices and protections apply to corporations including nonprofits. These laws prohibit employers from retaliating against employees who “blow the whistle” on their employer’s financial management or accounting practices, and they protect individuals providing information to law enforcement about the possible commission of a Federal offense and individuals who share knowledge of fraud against the U.S. government with relevant authorities.

The Internal Revenue Service (IRS) requires tax-exempt organizations to report on the annual Form 990 whether they have adopted a written whistleblower policy. While a nonprofit organization is not required by the IRS to have a whistleblower policy in order to be tax-exempt, the IRS expects nonprofits to follow good governance practices, such as whistleblower protections, that ensure that the organization's assets will be used consistently with its exempt purposes.

According to the National Council for Nonprofits, more than 45 states have put in place whistleblower policies from retaliation in the workplace. For example, in Virginia, where the current OPTN contractor is based, the recently passed Virginia Whistleblower Protection Act (Va. Code § 40.1-27.3. Retaliatory action against employee prohibited) provides strong protections to:

* Employees or a person acting on behalf of an employee who in good faith reports a violation of any federal or state law or regulation to a supervisor or to any governmental body or law-enforcement official;
* Employees who are requested by a governmental body or law-enforcement official to participate in an investigation, hearing, or inquiry;
* Employees who refuse to engage in a criminal act that would subject the employee to criminal liability;
* Employees who refuse an employer's order to perform an action that violates any federal or state law or regulation and the employee informs the employer that the order is being refused for that reason; and
* Employees who provide information to or testifies before any governmental body or law-enforcement official conducting an investigation, hearing, or inquiry into any alleged violation by the employer of federal or state law or regulation.

Sample whistleblower policies are available online from the National Council of Nonprofits, Board Source, CAPLaw, and SHRM. These sample policies can help inform the development of a whistleblower policy specific to the OPTN and its unique public mission. Review of these sample policies suggests that nonprofits should:

* Set high standards for business and personal ethics, including honesty, integrity, and adherence to law;
* State those ethical standards and a clear “no tolerance” stance banning fraud, discrimination, harassment, and whistleblower retaliation in clear official policies adopted by the organization’s board of directors;
* Model those standards through the actions of directors, officers, and executives;
Offer full-throated, unequivocal encouragement to officers, employees, volunteers, employees of contractors and subcontractors, and other stakeholders and individuals to bring forward good-faith concerns and complaints, including regarding ethics violations, discrimination, harassment, fraud, waste, abuse, or illegal activity including violations of law or regulation;
Not require a loyalty oath or pledge or characterize the act of whistleblowing as in tension with one’s loyalty or commitment to the organization;
* Commit in writing to not retaliate when such good-faith concerns and complaints are brought forward;
State the consequences of retaliation, up to and including termination and prosecution under relevant Federal and state laws;
* Issue open-door policies and publish procedures that encourage employees to report concerns and complaints to their supervisor or to an alternate designated corporate designee or designees, which could be any manager or executive, a compliance officer, a human resources executive, another senior executive, or the organization’s board,, to support timely and appropriate internal resolution of problems;
* Provide a third-party independent ombudsperson or liaison who can receive reports of concern or complaint from those who are not comfortable reporting a complaint to any internal designee, including reports, for example, of wrongdoing by the organization’s senior executives, officers, or board members;
* State in writing the processes that will be followed to investigate any reports of complaint or concern, and that can be followed to appeal and resolve any disagreement over the results of the investigation;
* Draft policies and procedures in plain language with clear definitions of terms;
Not unduly limit or caveat the types of complaints or concerns that employees or contractor/sub-contractor employees can bring forward;
* Communicate standards, policies, and reporting procedures to all officers, employees, volunteers, and employees of contractors and subcontractors, in handbooks, through signage in locations employees gather, by email, during meetings, on intranets, and through other frequent and easily accessible communications;
* Allow for complaints to be brought forward in person, in writing, or anonymously such as through online forms or designated phone numbers;
Commit to confidentiality to the extent feasible in handling complaints and protecting those who “blow the whistle;”
* Require that supervisors report any employee complaints they receive regarding ethics, fraud, waste, abuse, harassment, discrimination, and potential illegal activity to a designated ethics or compliance official;
* Require designated official(s), ombudspeople, or liaisons to track and ensure all such complaints are investigated and resolved;
Require designated official(s), ombudspeople, or liaisons to provide a summary of all such employee complaints to the organization’s chief executive and/or board;
* Require the designated official(s), ombudspeople, or liaisons to provide a summary of any complaints regarding accounting, controls, or other financial wrongdoing to the organization’s Treasurer and/or audit/finance committee and to work with that committee to resolve such matters;
* Connect the whistleblower policy and procedures to other relevant corporate policies, such as those related to ethics, document retention, financial controls, discrimination, harassment, and conflicts of interest, and ensure consistency and clarity across those policies and procedures;
* Train supervisors and employees on these policies and procedures to ensure consistent implementation; and
* Communicate and point to relevant Federal and State laws that protect whistleblowers and informants, beyond those processes internal to the organization.


Related to Federal Contracts

In addition, given that the OPTN is operated in the public interest and for the public good under federal authority provided to HRSA, the laws and established practices for whistleblower policies and procedures which apply to federal contracts, specifically to federal contracts, must also be considered and integrated into any whistleblower policy of the OPTN, as well as OPTN communications and notifications regarding whistleblower policies to its employees, sub-contractors, and the public.

Whistleblower protections related to Federal contracts are provided under 41 USC § 4712 to employees of a federal contractor, subcontractor, grantee, subgrantee, or personal services contractor who disclose information providing evidence of gross mismanagement of a Federal contract or grant, a gross waste of Federal funds, an abuse of authority relating to a Federal contract or grant, a substantial and specific danger to public health or safety, or a violation of law, rule, or regulation related to a Federal contract (including the competition for or negotiation of a contract) or grant.

Such individuals are protected from retaliation and cannot be discharged, demoted, or otherwise discriminated against if they report such wrongdoing to an inspector general, the Government Accountability Office (GAO), members of Congress or representatives of congressional committees, a Federal employee responsible for contract or grant oversight or management an authorized official of the Department of Justice or other law enforcement agency, a court or grand jury, or a manager or other employee of the contractor, grantee, or personal services contractor who has responsibility for investigating, discovering, or addressing misconduct. Types of prohibited retaliatory employer actions for whistleblowing include poor performance reviews, demotion or termination, denial of training or travel, reassignments or assignments to duties inappropriate for one’s grade level, failure to promote or appoint to a position, denial of benefits or telework, retaliatory investigations, and other adverse personnel actions

If a whistleblower believes they are facing unlawful retaliation because of a protected disclosure, they may file a claim with the Office of Inspector General (OIG) of the agency that awarded the contract or grant. In the case of the OPTN, that is the HHS OIG, which has published relevant whistleblower guidance and procedures. The OPTN board should include this HHS whistleblower guidance for contractor employees in its own whistleblower policy and in its communications to its employees, and the public.

Consistent with the law and with the letter and spirit of Federal policies such as OMB Memorandum M-22-04 on Promoting Accountability through Cooperation among Agencies and Inspectors General, OPTN should also state affirmatively its intent to cooperate with the HHS OIG, GAO, Congress, and the U.S. Departments of Justice and Labor on any investigations that may occur as a result of whistleblower complaints or other informant sources of information regarding potential illegal activity.

Specific Concerns with the Draft OPTN Whistleblower and Code of Conduct Bylaws

1) Chilling effect of combining a code of conduct with duty of loyalty pledge with a whistleblower policy

OPTN is seeking public comment concurrently on a Code of Conduct and on whistleblower protections. The connection and conflation of these two matters does a disservice to any goals that HRSA or the OPTN may have for encouraging an “open door” culture where complaints and concerns regarding wrongdoing can be brought forward without fear of reprisal. To discuss whistleblower protections at the same time as putting forward a code of conduct that requires employees and volunteers to annually attest to their agreement with always acting “for the good of the OPTN” and with a duty of loyalty pledge to “respect the outcome of a direction taken by the Board of Directors or committee,” without acknowledging that whistleblowing can be in the interest of the OPTN (because adherence to the law and to the interests of patients and the public should be foremost for the OPTN) certainly discourages those who may have good-faith complaints and concerns regarding wrongdoing by OPTN executives, Directors, or committee members.

To better reflect OPTN’s duty and mission to patients, OPTN should revise the duty of loyalty provisions to include reference to making decisions on the basis of OPTN’s public mission to save lives and serve patients, to abiding by OPTN’s whistleblower policies and federal and state whistleblower laws, and to cooperating fully with law enforcement and with the MPSC and HRSA on any investigations into wrongdoing related to the OPTN.

Similarly, those signing this Code of Conduct should have a “duty of care” first and foremost to patients, their families, and the public, and only secondarily to the effectiveness (not the corporate interests) of the OPTN.

2) Further chilling effect of the compliance officer being not independent from the Board of Directors, and not empowered to investigate or prompt an independent investigation of complaints about director and officer wrongdoing

It is promising that OPTN makes available multiple pathways for reporting concerns, including a hotline for members, a patient safety portal, an email address, and a general phone number. However, for complaints either regarding Code of Conduct violations or other complaints of wrongdoing to go to a Compliance Officer who is a Director of OPTN and/or to the Executive Director or President, and then to be deliberated on and resolved by the Board of Directors and ultimately the Executive Committee, will inevitably have a chilling effect for any whistleblowers or other individuals who may want to report wrongdoing by said President, Executive Director, or other Directors. We echo the Patient Affairs Committee in strongly urging that the Compliance Officer be someone independent from the Board of Directors and Executive Director, such as a Human Resources leader or third-party vendor. (We further note that the current President-Elect of the OPTN has been specifically named in investigative reporting as having threatened retaliation against Congressional witnesses, highlighting the dangerous absurdity of the current draft proposal.)

Equally important is that this independent third-party Compliance Officer either be empowered to directly investigate claims against the Executive Director, Board of Directors, and committee leadership or to trigger an independent investigation by a qualified and unbiased third party, HHS/HRSA, and/or the HHS Inspector General.

Similarly, having the Executive Committee be ultimately responsible for resolving violations of the OPTN Code of Conduct (without, it should be noted, explicitly recusing the accused from Board and committee deliberations regarding such potential violations) is an inappropriate level of self-oversight. All such submitted reports should be reported to HRSA, as should their resolution, for transparency into Board deliberations on such matters. Ideally, a third-party ombudsperson should be appointed by HRSA to investigate such claims.

Transparency into these processes is also essential, both for those charged with overseeing the OPTN (HHS/HRSA, the HHS Inspector General, GAO, and Congress), and for the public. The Compliance Officer and OPTN Board of Directors must be required to report serious good-faith complaints regarding both Code of Conduct violations and any other type of wrongdoing reported by whistleblowers or any source to the MPSC and HHS/HRSA.

Related: HHS/HRSA should set some criteria for which claims and complaints rise to the level of needing to be reported to HHS/HRSA and the HHS IG, and that OPTN along with timelines for reporting such complaints (and their resolution). For example, in addition the existing “Wakefield Criteria” for reporting specific patient safety events to the MPSC and HHS/HRSA (see OPTN Policy 18.5: Reporting of Living Donor Events), which should be integrated into and referenced in these proposed bylaws, HHS/HRSA should set clear timelines for reporting whistleblower and other patient advocate and stakeholder complaints related to ethics violations, violations of the code of conduct once instituted, complaints of financial fraud, waste, and abuse; and complaints of potential harassment, discrimination, or bias either illegal or inconsistent with HHS/HRSA and OPTN regulations, bylaws, and policy; or other potential illegal activity.

3) Giving teeth to OPTN’s stated commitment to provide whistleblower protections to all who report wrongdoing.

OPTN states in its proposal its intent to apply whistleblower protections to “all” – “including those participating as Directors, Committee members and volunteers as well as the general public (and not only to members subject to OPTN policies).” It also notes its intent to “clarif[y] the open-door policy for reporting, noting that anyone may make a report in good faith and will be protected from retaliation.” These are admirable intentions, consistent with our broad points above regarding the unique nature of the OPTN, its national scope, and its complex, multi-organization network.

However, the Whistleblower bylaws as proposed fall far short of giving any real teeth to this stated commitment. To make this commitment real in practice, OPTN should make significant revisions to and strengthen the proposed Whistleblower bylaws and also create, publish, and broadly disseminate robust and clear processes for complaint submission, investigation, and resolution and for responding to any retaliation that may occur counter to the stated policy.

For example, the proposed Whistleblower bylaws direct all complaints to the OPTN Executive Director or the OPTN President, and do not provide for reporting to an independent third-party, noting that the Executive Director or President may choose to engage independent assistance with investigation. The proposed Whistleblower bylaws do not provide a process or timeline for investigation of whistleblower complaints or state or clarify the role of the MPSC, HHS/HRSA, the HHS IG, or law enforcement.

The proposed Whistleblower bylaws only state a no-retaliation policy for reporting violations of ethics, law, or regulation, but do not explicitly reference no retaliation for reports of harassment, discrimination, waste, abuse, patient safety (per the existing policies and MPSC process), wrongdoing related to the federal contracting process (see above), etc. A much more specific list of what types of wrongdoings all are encouraged to report should be added.

In addition, the proposed Whistleblower bylaws are inconsistent in clarifying both who can blow the whistle (ideally, anyone) and who may not retaliate (ideally, no one – no directors, officers, employees, or volunteers of the OPTN and its members, contractors, or subcontractors may retaliate).

Worse, the proposed bylaws are silent on how the no-retaliation policy would be enforced in practice across OPTN contractors, subcontractors, and member institutions and what the repercussions would be for any such retaliation if proven. What power does OPTN have to prevent its members from retaliating against whistleblowers, for example? Remove from OPTN participation? This should be clearly stated.

International Society for Heart and Lung Transplantation | 05/15/2024

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View attachment from International Society for Heart and Lung Transplantation

Anonymous | 05/15/2024

I am in favor establishing a code of conduct and whistleblower protection bylaws. I believe it is crucial to the integrity of any proper organization that not only are there a set of rules and standards of which the organization and its associated individuals to abide by, but also that those whom are courageous enough to stand for that code by way of whistleblowing are protected.

Without whistleblower protections in place, those who do witness violations to the organizations code are much more likely to remain silent out of fear of retaliation. These protections would allow for a more stable and consistent feedback loop within the organization to ensure that the code of conduct is withheld and any/all adjustments that need to be made can be brought to the table.

NATCO | 05/15/2024

NATCO appreciates the efforts of the OPTN Executive Committee in their efforts to develop these policies and of HRSA for recommending this policy be included for public comment, recognizing the potential member burden implications. Although NATCO’s membership supports the concepts behind these initiatives, there were concerns regarding the appointment of the OPTN Compliance Officer from the OPTN Board of Directors. Our concerns include that an OPTN Board of Director is a volunteer position, with most directors holding a full-time career outside of the BOD role. The director may not be able to dedicate the appropriate time needed for this responsibility. In addition, the membership believed that this role should be held by an individual with compliance experience. This competency may not be present on any given OPTN Board.

OPTN Patient Affairs Committee | 05/14/2024

The OPTN Patient Affairs Committee appreciates the work done by the Executive Committee to develop this proposal and the opportunity to provide feedback. The Committee has carefully reviewed the proposal and shares the following thoughts for consideration:

In the proposed Bylaws:

The Committee feels strongly that the Compliance Officer should not be a member of the OPTN Board of Directors, but rather someone separate from the OPTN Board who both OPTN members and the general public see as completely neutral in their decision-making. Committee members stated the optics of filling the compliance officer role internally (i.e. with a current member of the Board) are poor if there is a desire to foster trust in this process. They also felt this could also be perceived as a conflict of interest. A third party was recommended for external review and adjudication to avoid the potential instances of retaliation or retribution within the Board. The Committee agreed that distrust in this process may impact an individual’s willingness to volunteer.

The Committee recognized that some companies or organizations use a Human Resources staff person to handle review of Code of Conduct allegations. One member shared that based on his personal experience as a member of the military, the military’s Inspector General model may also be an alternative. This investigator reviews the report, speaks to the individual, and reviews the evidence before reporting findings to allow for an independent assessment. This position could also be expanded beyond intake and investigation of issues to serve as an advisor to teach, mentor, and train volunteers regarding questions or actions related to the Code of Conduct.

The Committee asked for more clarity regarding due process for both Code of Conduct and Whistleblower reporting. They asked what the process for rebuttal or appeal would be in these instances? One member asked whether volunteers should secure an attorney to protect an individual from allegations? If violations of the Code of Conduct include consequences up to removal from office, the processes should be made abundantly clear to volunteers.

The Committee stated that clarity (including examples) is needed related to volunteers making statements on behalf of the OPTN. Committee members were very concerned regarding their ability to work with other patient organizations to share education and OPTN news. Clarification is needed regarding whether this outreach work is still permissible during Committee service. As written, they believe this section of the proposed Code of Conduct is too narrowly defined, referring only to publications.

Committee members were also concerned regarding their ability to share personal thoughts as a patient. For example, “If I am a patient member of the Board and I comment on something (positively or negatively) as a patient on my personal Facebook page, am I in violation of this Bylaw?” The Committee seeks language clarifications here to denote what is and is not allowed within this Bylaw.

In the proposed Code of Conduct:

One Committee member asked what industry Code of Conduct language was evaluated during its development (e.g. nonprofit vs. for-profit). This member stated that, with the new legislation allowing for profit companies to bid for contracts, the Committee feels it is important to think more broadly in this area (i.e. consider Code of Conduct language from for-profit entities), especially when considering that the OPTN may ultimately include both for profit and nonprofit entities under its umbrella.

Several members of the Committee stated the proposed Code of Conduct was seen as overwhelming from a patient perspective, particularly for new members who are volunteering with the OPTN for the first time. There was concern that individuals may be too intimidated to raise concern without feeling that they might be “in trouble” for raising concerns or questions. This also could impact interest in volunteering for the OPTN.

Committee members shared concerns that individuals with a difference of opinion will be haunted by their statements and urged that differences of opinion should not lead to retaliation. The Committee believes that this point should be included in the Code of Conduct.

Dev Desai | 05/14/2024

I support the development of a code of conduct for OPTN Directors and volunteers as well as creating protections for whistleblowers; however, there are details which I believe would benefit from changes and clarifications. The creation of the position of a compliance officer is important to review, adjudicate and report violations of the code of conduct and provide protection to whistleblowers; however, this position should be independent of the board of directors. The compliance officer should report to the President of the OPTN or in the case of conduct concerns of the President, then to the Board of directors. Independence of the compliance officer is important to maintain public trust in the transplant system.

American Society of Transplantation | 05/08/2024

The American Society of Transplantation supports the OPTN bylaws changes proposed in, “Proposal to Establish Code of Conduct and Whistleblower Protection Bylaws.” The proposal would benefit from additional clarification of the process for handling alleged violations and review to ensure the language is consistent with legal terminology and standards for corporate governance.

Denise Abbey | 05/01/2024

I am conflicted about compliance officer being a member of the board. Is this the person who will be investigating complaints received? To avoid appearance of conflict I suggest the compliance officer be completely independent of the board to ensure neutrality. If a complaint is received about the board, can this individual be trusted to investigate themselves? OPTN needs to ensure this is a policy update the public can trust and have faith in the process.

Would posting on Facebook or any other social media about your own personal experience (whether good or bad) potentially be a violation of the Code of Conduct if you are serving in some capacity?

Julie Spear | 05/01/2024

I don’t support the proposal as written.

Section 2.7A states that the OPTN will select a member of OPTN Board of Directors to serve as the OPTN Compliance Officer. The Compliance Officer should not be a member of the Board of Directors for the following reasons:

This position requires more than the HR experience as noted in the proposal. This is a Risk Management position; the Compliance Officer should not be a volunteer position, someone who most likely has a full time job outside of this role, the perception from the policy as written is that this position is not important, it should not be a ‘side gig’; whether real or perceived there are potential conflicts of interest inherent in the selection of the Compliance Officer position from member Directors between their duties to the Board of Directors and the whistleblower. This would be an ineffective position as proposed.

I strongly suggest, in alignment with the OPTN Modernization Initiative’s pursuit of ‘best in class’ vendors that a third party Risk Management consultant be retained to function as the OPTN Compliance Officer. The consultant is an expert in this field and can also be objective in their duties. Section 2.10. should state that the OPTN will engage a third party consultant as the OPTN Compliance Officer.

Additional clarification is required for an OPTN volunteer speaking from their personal viewpoint and experience versus speaking on behalf of the OPTN. Without further distinction, valuable input from OPTN volunteers may be stifled due to the fear of violation of the Code of Conduct. What communication specifically will require prior OPTN approval? Would this apply to OPTN volunteers providing Public Comment feedback that is published on the OPTN website?

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.