OPTN_-_HRSA_responses_to_RFI.pdf

OPTN RFI Responses & HRSA’s answers

HRSA received the following comments and questions from multiple sources during the RFI phase. HRSA will take into consideration this information received when developing the solicitation.

Responses to the specific questions and concerns posed are below:

1. A concern was raised about the limited window of opportunity for addressing this RFI, posted on December 1, 2017, with a closing date of December 22, 2017. Historically, six to eight weeks were offered for response. The concern is that this compressed timeline limits opportunity for potential competitors to prepare a response and may favor the incumbent in continuing this contract.

HRSA Response: It appears that there may be a slight misunderstanding between the Request for Information (RFI) and a Request for Proposals (RFP) postings. The RFI only seeks questions and/or comments on the proposed PWS whereas the RFP requires potential bidders to submit a full proposal. HRSA does typically allow a longer window for interested parties to submit a proposal in response to an issued RFP but the window for responses to an issued RFI is typically shorter. If more time is required to respond to either the RFI/RFP, then offerors have the opportunity to submit a deadline extension request to the Contracting Officer for consideration.

2. Feedback was requested on the impact of Sections 3.5, 3.5.7, 3.6.2 and their requirement that all official OPTN data “shall be collected through OMB approved data collection forms, unless an exception applies under the Paperwork Reduction Act such that OMB approval is not required.” Currently, these forms have expiration dates that are sometimes years out. Feedback was requested on: (1) the timeline and availability for approval of updates to these forms outside of the standard renewal process and (2) the impact on implementation of new matching or allocation policies that are driven by data captured on these forms, and whether the OMB approval process will delay implementation.

HRSA Response: Modifications to OMB-approved forms may be made outside of the regular review cycle through a “change memo” process, if the changes are minor. The clearance process is generally not as lengthy when this process is used, and HRSA intends to use this process when applicable. Significant substantive changes require that the entire set of forms go through the federally required Paperwork Reduction Act process, which includes a required opportunity for public comment.

3. Section 3.2.4 requires the contractor to submit any proposed changes to policies, bylaws, standards, and guidelines to the COR for review prior to review and approval by the board. Further insight into this is sought, as the current committee and board structure of the OPTN includes HRSA representatives as ex officio members of each group. This would imply that there is HRSA presence for the development of all proposals from concept through board consideration. Submitting these materials to the COR before dissemination to the board seeks to add another layer of administration that further lengthens the policy development and implementation process.

HRSA Response: While a HRSA representative participates as an ex officio member of each OPTN committee, and is present at meetings and conference calls when development of proposed changes to policies and bylaws occurs, proposals often change as they are being developed, resulting in a final product that may differ from the original draft. Providing a final version review of proposals before submission to the Board would strengthen HRSA’s oversight role over the operation of the OPTN and is intended to ensure that any matters of concern are identified earlier, rather than later, in the OPTN process.

4. The following changes to the draft PWS are suggested:

• that references to the contractor supporting or aiding the OPTN be simplified to the more appropriate, “the Contractor shall . . .” perform or provide the desired service.

• that the current working partnership between the community and the government continue, and requests for new reviews and approvals without the participation of the transplant community be removed.

• that the requirement for HRSA approvals of abstracts and manuscripts prior to submission be removed and that HRSA rely on the expertise of the scientific community for publication and presentations and existing methods to evaluate scientific merit.

HRSA Response: HRSA values the working partnership it has developed with the community.

HRSA’s oversight responsibility for the OPTN contract does require appropriate review of materials produced under the contract, and in certain cases, approval of materials produced under the contract. HRSA’s intent is not to evaluate the scientific merit of the abstracts and manuscripts, but rather to ensure that work produced under the contract is undertaken to support contract activities. HRSA will continue to review the PWS language and final requirements will be included in the solicitation. Upon posting of the RFP, interested parties will have an opportunity to submit questions requesting clarification or an explanation of components contained in the final PWS language.

5. The following change to the PWS is suggested:

• that references to the federal travel policy be removed and that the government rely on its oversight role, and direct participation in the OPTN Finance Committee and BOD, as well as the skills of the contractor to achieve the most cost-effective travel and meeting planning approach

HRSA Response: HRSA will review this suggestion and revise language of the PWS if necessary. However, under federal contracts, contracts are required to cap their travel expenses in accordance with federal travel regulations.

6. It is suggested that the requirement for OMB approval of all OPTN data elements be removed and replaced with a description of the thorough, principle-based, public vetting process used by the OPTN to determine the value of proposed new data collection

HRSA Response: Guidance for data collection is linked to the Paperwork Reduction Act and overseen by the OMB approval process. However, HRSA is committed to working to streamline administrative burdens, consistent with applicable laws.

7. It is suggested that section 3.11 of the draft PWS be eliminated, and replaced with requirements that the contractor designated as the OPTN meet industry standards for the protection of confidential health information

HRSA Response: The provisions in Section 3.11 are required by Departmental policy.

8. Change to the draft PWS: that the “pilot” label be removed from the OPTN KPD program

HRSA Response: HRSA continues to consider the OPTN KPD program to be a pilot project. If the “pilot” status is removed during the contract’s period of performance, HRSA will work with awardee to modify contract language.

9. It is suggested that the requirement for public comment in each OPTN meeting be removed, but the requirements that the OPTN be transparent and inclusive of input from patients, professionals and the general public remain.

HRSA Response: HRSA will review the language in the PWS. HRSA’s intent is to ensure appropriate transparency and include public and community input into the OPTN policy making process.

10. It is suggested that the requirement for annual demonstration of staff experience and expertise be removed from the task language and that the corresponding deliverable, D52 Annual report of Contractor staffing expertise, be removed.

HRSA Response: HRSA will review options for the demonstration of staff experience. HRSA’s intent in this requirement is to ensure appropriate diversity of contractor professional expertise to support the OPTN policy making process and OPTN contract activities. The final requirements will be stated in the solicitation.

11. The following are suggested:

• that the optional task to develop a transition-out plan be clarified to take place only after the selection of a successor contractor other than the incumbent contractor

• that a separate optional task be added to reflect the government’s option to acquire a license to the Contractor’s specified computer software systems used to perform the functions of the OPTN.

HRSA Response: HRSA will continue to review the PWS language and final requirements will be included in the solicitation. Upon posting of the RFP, interested parties will have an opportunity to submit questions requesting clarification or an explanation of components

12. Currently, OPTN revenue is largely derived from registration fees. While the intent may have been to offset the cost of maintaining an operation that listed patients for transplant, this practice provides an incentive for the OPTN to list patients for transplant, and to promote the practice of “multiple listing” (which some have argued is unethical because it provides an unfair advantage to wealthy transplant candidates). More importantly, there is no financial incentive for the OPTN to transplant patients. The OPTN contractor should derive a substantial portion of revenue from transplants performed. This could be accomplished by requiring OPOs to pay a stipend to the OPTN for each organ transplanted. The OPOs could recover this by adding this cost to their organ acquisition fee. All OPTN contractor employees could receive a small bonus based on increases in the number of transplants performed each year.

HRSA Response: HRSA will review the provisions of the PWS pertaining to registration fees. OPTN registration fees must conform with the requirements set forth in the OPTN final rule, 42 CFR 121.5(c). The final requirements will be stated in the solicitation.

13. The current Board of Directors (BOD) has 43 members and meets twice a year. We recommend a smaller number of BOD members, with in face meetings twice a year and electronic meetings twice a year. The Executive Committee can make policy changes if necessary (and did so in response to the recent court order).

HRSA Response: The OPTN Final Rule has specific requirements regarding the composition of the OPTN Board. These requirements are designed to ensure involvement of a diverse cross-section of the transplant community including representatives from organ procurement organizations, transplant centers, health associations, health professionals, and the general public. The Board composition also attempts to ensure geographic dispersion across the country. Additionally, the Final Rule states that the OPTN “shall establish a Board of Directors of whatever size the OPTN determines appropriate”, therefore HRSA does not anticipate including a specific set Board size in the solicitation.

14. This OPTN seeks to make policy changes by obtaining consensus. However, for some issues, such as allocation within a local DSA, consensus will never be achieved. This is why the issue of minimizing the effect of geography, as articulated in the Final Rule, has never been addressed. Policies that benefit patients waiting for organ transplants, and that affect the number of donors, should be adopted, irrespective of consensus.

HRSA Response: HRSA will keep this suggestion in mind as we continually explore ways to increase efficiency in the OPTN policy development and implementation process, including changes to current policies. HRSA Will continue to review the PWS language and final requirements will be included in the solicitation. Upon posting of the RFP, interested parties will have an opportunity to submit questions requesting clarification or an explanation of components

15. The requirements of the Final Rule should become policy for all organ transplant allocation algorithms.

HRSA Response: The specifics of allocation algorithms are not part of the PWS nor contract language.

16. The OPTN’s process for policy change is cumbersome and takes too long. When lives are at stake, faster implementation of policy change could reduce waitlist deaths. With rapid report of outcomes, the short-term impact of policy changes can be assessed and policies could be reverted back, with resumption of analyses to determine why the change failed, and how to correct it.

HRSA Response: HRSA will keep this suggestion in mind as we continually explore ways to increase efficiency in the OPTN policy development and implementation process including changes to current policies. HRSA will continue to review the PWS language and final requirements will be included in the solicitation. Upon posting of the RFP, interested parties will have an opportunity to submit questions requesting clarification or an explanation of components

17. To streamline the process of policy change, the number of committees should be reduced. This is mentioned in the OPTN strategic planning process.

HRSA Response: HRSA will review the provisions of the PWS pertaining to committees.

HRSA’s intent with the PWS is to provide additional flexibility to the contractor regarding committee composition. The final requirements will be stated in the solicitation.

18. The OPTN contractor is becoming a large repository for secure data storage.

Outsourcing data storage to a data storage company (Amazon, Google) should be investigated and considered.

HRSA Response: Data obtained, stored, and maintained on behalf of the federal government is subject to specific security and privacy requirements. Given continuing advancements in technology, HRSA will work with the awarded Contractor to explore the most appropriate data storage solutions to suit the needs of the OPTN.

19. The OPTN contractor should have more oversight responsibilities of OPOs.

Currently, metrics for OPO performance are related to organ donor numbers. There are no requirements for the number of livers, hearts, or lungs. This is unacceptable.

HRSA Response: HRSA appreciates your comment in regards to OPO oversight; however, specific performance metrics are not part of the PWS nor contract language.

20. There is considerable variation in the use of First Person Authorization (FPA) by the 58 OPOs. In most states, the UAGA has the legal weight of an advanced directive. The OPTN should work with OPOs to standardize the appropriate use of FPA. Some FPA individuals believe their next- of-kin have the right to revoke permission for donation. The OPTN contractor should fund projects to educate FPA individuals about their decision.

HRSA Response: State laws govern consent to donation, including FPA. This is beyond the scope of the OPTN Contract.

21. The OPTN contractor should work with OPOs to increase the number of FPA potential donors.

HRSA Response: The standardization of state FPA laws is beyond the scope of the OPTN contract.

23. The current practice of the OPTN contractor using fees charged to candidates for listing as a source of operating revenue provides an incentive for the OPTN contractor to list patients for transplant, and to promote the practice of “multiple listing” (which some have argued is unethical because it provides an unfair advantage to wealthy transplant candidates). More importantly, there is no financial incentive for the OPTN to transplant patients. Can the Division of Transplantation entertain a contract proposal that would provide a financial incentive to increase the number of registered donors and the number of organs transplanted?

HRSA Response: The OPTN final rule, 42 CFR 121, provides two streams of funding to support the operations of the OPTN: Federal appropriated dollars and registration fees charged to patients to be placed on the organ transplant waiting list. NOTA caps the federal appropriated portion to up to $7 million per fiscal year. Patient registration fees are used to fund the remaining operations of the OPTN.

24. One respondent sought clarity about what government-furnished property will be provided.

HRSA Response: There are no assets, property, or computer equipment that will be provided to the awardee. A bidder’s proposal must demonstrate that they have the staff, facilities, equipment, including software, to perform the required services that support the OPTN.

25. How can a new contractor realistically compete against the current contractor with the existing governing structure, even if new bylaws were proposed, given the size and composition of the Board of Directors (BOD)?

HRSA Response: Please see the response to #13.

26. One respondent displayed an interest in discussing how an OPTN contractor could be funded differently.

• Some registration fees would be charged to cover the administrative costs associated with maintaining a list. As part of organ acquisition fees, OPOs would pay the OPTN for each organ transplanted.

• OPTN leadership and staff would receive bonuses based on increased numbers of transplants from one year to the next or semi-annually. Some OPOs do this now.

• The OPTN would use revenues to fund research proposals to:

• increase the number of registered organ donors.

• increase the number and quality of organs for transplant.

• test safety of transplanting organs assessed ex-vivo.

• test safety of transplanting organs recovered from uDCDDs.

HRSA Response: The OPTN final rule, 42 CFR 121, provides two streams of funding to support the operations of the OPTN: Federal appropriated dollars and registration fees charged to patients to be placed on the organ transplant waiting list. NOTA caps the federal appropriated portion to up to $7 million per fiscal year. Patient registration fees are used to fund the remaining operations of the OPTN. Legislative changes are required to change this model.