Amendment 0001 Questions Answers SRTR.pdf

Amendment Number 0001

RFP No. 75R60220R00019 Scientific Registry of Transplant Recipients

Questions & Answers

1. The RFP states that a "Small Disadvantaged Business (SDB) Participation Plan, dated TBD is attached herto and made part of this Contract." However, no such attachment can be found.

Additionally, there is mention of FAR 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting. However, this contract clause is not included in the list of contract clauses (pg. 20-23). Can the government please confirm that a FAR 52.219-25 does not actually apply to this solicitation/contract?

Answer: Section G9 covers instructional provisions that may apply to the offeror’s sub-contracting plan. It is TBD, since that date will be established at time of award and with that HRSA’s approval of the selected offeror’s sub-contracting plan. The attachment is in reference to the sub-contracting plan (attachment F of the solicitation).

2. The RFP specifies specific small business goals for the contract and states that the Offeror's

Subcontracting Plan "must meet or exceed" the FY19 HHS subcontracting goals. Is the government willing to accept less than agency goals if rationale is provided, due to the specialized nature of work, which limits subcontracting opportunities?

Answer: Offerors may submit a sub-contracting plan that fits their approach for HRSA’s evaluation. It will be determined at time of evaluation id such plan is acceptable. If the plan is less than agency goals, please provide a rationale.

3. The RFP states that quote shall include three (3) past performance references where the Offeror was the prime contractor or subcontractor for relevant work completed within the past three (3) years. Can projects that are currently active be included as past performance or only completed projects?

Answer: As long as the projects are of relevant work.

4. If the contractor has not received CPARS for a project either because the government did not provide one or it is a commercial agency, can it still be included as a past performance with the client being sent the Past Performance Questionnaire to complete?

Answer: Yes.

5. The RFP indicates that “CPARS ratings for contracts with Government agencies in Volume II". Can the government please confirm that this should be included in Volume III the Past Performance volume not Volume II the Section 508/VPAT volume?

Answer: Offerors shall submit copies of their CPARSs ratings for contracts with Government agencies in Volume III.

6. Can the government please confirm if all the data that OPTN collects from transplant centers and OPO will be transferred to the SRTR under this agreement?

Answer: Following completion of a data user agreement between the OPTN and SRTR contractors, all official OPTN data will be provided to the SRTR contractor on a regular basis (currently monthly).

7. Can the government also share what the current protocol and format is for transferring data on a monthly basis?

Answer: the OPTN contractor submits data monthly to the SRTR via encrypted database files through a Secure FTP site.

8. Task 7 of the PWS requires the contractor to host both secure and public websites. Can the

Government share if these websites are currently hosted in the cloud or on the incumbent’s premises and if/how these websites will be transitioned to the new contractor? If these websites are in the cloud, can the Government share which cloud service provider and if the contractor should include the cost of these resources in their budget? Can the Government provide a plug number for cloud website hosting services to provide transparency into procurement requirements for non-incumbents?

Answer: The government cannot disclose the arrangements made by the current contract to address current contract tasks. Offerors should propose their best solution to the task requirements and should include the costs necessary to secure these solutions in their proposed budget. The question regarding a plug in number does not include enough clarity to provide a response.

9. Are there an existing operations manual that can be shared?

Answer: Documentation for existing contract-supported activities will be provided post-award.

10. Can the Government provide a list of external data sources already linked to the OPTN data, including disease specific registries?

Answer: All linkages to date have been for research purposes and cannot be released.

11. Will the historical datasets and programming codes be provided to the new contractor as part of the transition process?

Answer: In the event of a contractor transition, historical datasets, coding, and resulting analyses will be included in documentation transferred from the incumbent contractor to the new contractor.

12. Can the Government share the average number of requests SRTR receives annually for data and support from HHS and external to HHS?

Answer: Approximately 7 data requests from the public per month. Support is requested for approximately 1 or fewer out of the 7 requests. HHS typically directs data requests to the

OPTN.

13. Does the government currently hold the ownership / license rights to the SAMs software

(LSAM, TSAM, KPSAM) that is requested to move to open-sourcing?

Answer: The government holds the ownership/licensure rights to the existing SAMs software. New, updated, and modernized SAMs software is being developed under the current contract to replace the existing software, and this new software will be made available through open source licensing and distribution.

14. The PWS states that for Task 10, “The updated and modernized SAMs produced under the prior SRTR contract include the: Liver Simulated Allocation Model (LSAM); Thoracic Simulated Allocation Model (TSAM) for heart and lung; and Kidney/Pancreas Simulated Allocation model (KPSAM).”; and that, for Task 10.1, “Maintain and update the modernized SAMs produced under the prior SRTR contract to support the analytical needs of the OPTN.” In the SRTR website, the SAMs manuals include information when the status updates on data input parameters occurred, which were between 2009 through 2012 (e.g., https://www.srtr.org/media/1361/lsam-2019-User-Guide.pdf p.84;

https://www.srtr.org/media/1294/tsam-2015-user-guide.pdf p.93).

Can the government please confirm those updates were the most recent updates? Given that there is no specific requirement for any additional modernizing of the SAMs, would the government support additional modernizing or updating of the SAM models as part of this process?

Answer:

The most recent updates to the existing SAMs software were made on the following dates:

• KPSAM: most recent update 12/2019

• TSAM: currently finalizing an update now, and the most recent update before that was

9/2018

• LSAM: most recent update 6/2019

These updates are not the “updated and modernized SAMs produced under the prior SRTR contract” referenced in the PWS. Updated and modernized SAMs software is being developed under the current contract will be made available through open source licensing and distribution.

Task 10.1 is the Government’s requirement for the SRTR contractor to maintain and further update the “updated and modernized SAMs produced under the prior SRTR contract.”

Maintenance and updating of the SAMs is an ongoing task of the contract. Updates need to be made as OPTN policies change.

15. Can the Government provide information on what data fields are collected in the current Living Donor Collective?

Answer: See the attached OMB-approved data collection fields for participants in the Living Donor Collective.

16. Can the Government provide an extension of twenty days after questions are answered so responses to questions can be considered in our proposal response?

Answer: No extension is planned at this time.

17. Does the SRTR contractor compensate members for SRTR Review Committee participation?

Answer: Participation on the Review Committee is voluntary and there is no compensation supported through the contract. Travel expenses for Review Committee members may be reimbursed through the contract. The SRTR Contractor provides all administrative support necessary for the functions of the Review Committee and any of its subcommittees and working groups.

18. Is there any plan to consolidate the data management and dissemination activities OPTN and

SRTR are both performing for transplantation stakeholders?

Answer: There is not a plan for consolidation at this time. The Government does not wish to support redundant activities, and both the OPTN and SRTR contractors are required to work together to provide complementary activities.

19. How do you envision the role of the SRTR being impacted by the possibility of a new Modern Resource Allocation System forming the IT backbone of the OPTN work? For example, contemporary approaches to data management and hosting might support greater efficiency in data collection (OPTN) and data curation, analysis and reporting (SRTR), enabling faster and more agile evaluation of new policies and implementation of capabilities and functions.

Answer: HRSA’s recent market research to collect information on a Modern Resource Allocation System does not reflect any future HRSA procurement decisions. This market research also does not reflect any anticipated changes in the roles of the OPTN and SRTR.

The SRTR contractor will need to meet the requirements of this contract.

20. What documents are required for subcontractors in the Business Proposal?

Answer: Please refer to attachment F of the solicitation.

21. What is the anticipated start date of the contract after award?

Answer: The anticipated start date is 9/21/2020.

22. Would conflicts of interest for clinical staff at a transplant program be mitigated at the personal or organizational level?

Answer: Mitigation needs to occur at the personal level.

23. RFP page 43, Section L.4.2.C Qualification of Key Personnel: If the Project Director and Deputy

Director are from different institutions does there need to be a designated accountable second party at the prime institution?

Answer: The PD and DD should be from the same institution.

24. RFP page 43, Section L.4.2. C Qualification of Key Personnel: Can the Deputy Project Director role be shared by two co-Deputy Project Directors?

Answer: Responses to the solicitation may include a proposal that includes two co-deputy project directors.

25. RFP page 44, Section L.6: Should Past Performance (Vol III) include CPARs ratings for subcontractors as well as the prime?

Answer: HRSA will evaluate only Prime’s Past Performance.

26. RFP page 44, Section L.6: Should Past Performance (Vol III) include CPARs ratings for only 3 contracts or should it include CPARs for all contracts in the past 3 years?

Answer: 3 is the minimum required. Offerors may submit more than 3 so long it is relevant to the scope of this solicitation. HRSA recommends being concise.

27. PWS, Tasks 2, 3, and 4: In-person meetings with the OPTN Contractor, OPTN COR, and SRTR COR

(Task 2.6 page 4), briefing meetings with HRSA COR (Task 2.10, page 10), and in-person OPTN committee meetings: Should we budget for in-person meetings as called for regardless of public health emergencies or other savings strategies?

Answer: In the event of a public health emergency, meetings may be held virtually.

28. PWS page 5-6, Task 3, 3.1 – 3.3: Are we correct to assume the in-person OPTN committee meetings will continue to occur at the same location (Chicago) and frequency as currently conducted.

Additionally, is it correct to budget for travel for SRTR staff in the SRTR budget or is this travel covered under OPTN contractor’s budget?

Answer: At this time, OPTN committee meetings are being conducted virtually due to the COVID-19 public health emergency. The number of OPTN meetings has not been reduced as a result of the emergency. When in-person OPTN meetings resume, we anticipate that they will continue to occur in Chicago and other locations; however, HRSA is not clear if the ratio of in-person to virtual meetings will change in the future. The OPTN contractor will continue to offer virtual participation options for all meetings. HRSA cannot anticipate the timeframe or frequency for in-person OPTN meetings in the future. Travel should be included in the contractor budget.

29. PWS page 7, Task 5: There are a number of focus groups/consensus conferences required for metric development including a requirement for an “open and transparent national meeting every third year” to review results of the evaluation process. Is it acceptable to propose virtual approaches to these meetings?

Answer: It is expected that this meeting will include a wide range of stakeholders and interested members of the public. Given the uncertainty about future large public meetings due to the current public health emergency, it is acceptable to propose virtual options to hosting meeting(s) of the scope required to complete the task.

30. PWS, Page 10, Task 7: The PWS names the domains srtr.transplant.hrsa.gov and securesrtr.transplant.hrsa.gov, and refers to content at both livingdonorcollective.org and srtr.org.

Would the .org domains be eligible for transfer to a new contractor?

Answer: Yes

31. PWS, Page 10, Task 7: Please provide the technical specifications of all the SRTR Websites in scope, including: Server architecture, server counts, Server Operating Systems, Server Memory and CPU, Web Server Software, Programming Languages Used, Content Management System, Version Management System, Database Software, Load Balancer Architecture, Firewall configurations, number of lines of code.

Answer: information on technical specifications, etc., will be included as part of transition of materials and information provided to any new contractor.

32. PWS, Page 14, Task 9.1: Do patient matching algorithms for additional data sources belong to the project, or are they Commercial Off-The-Shelf products?

Answer: The SRTR Analytic File that is derived from the OPTN data set is large and complex and contains PII. Ad-hoc algorithms for linkages that are in effect per current data use agreements would transfer to a new contractor. HRSA is not aware of COTS products being used to link additional data.

33. PWS page 14, Task 9: What should we expect the volume of data requests (RFA and Data release) to be?

Answer: Approximately 7 requests per month.

34. PWS page 18, Task 13.1 – Living Donor Registry: For the living donor collective, will software for the data collection portal, and all of its metadata be transferred, in addition to all previously collected data? Please provide a data collection data dictionary and current number of registered users.

Answer: Material developed under the current contract will transfer to any subsequent contractor. There are currently 10 sites participating in the Living Donor Collective. All 10 submit kidney data; of these, 6 also submit liver data. The SRTR data dictionary is available here: https://www.srtr.org/requesting-srtr-data/saf-data-dictionary/

35. PWS page 30, Task 15: We previously had an ATO with the NIH that allowed our Central Information Security Group (CISG) to perform our department security assessments. CISG does not implement any security for our department, but does advise and perform security assessments and scans. Will HRSA accept CISG for security assessments for the ATO? If not, will HRSA be providing the outside security assessment team for acquiring the ATO?

Answer: It is not possible to respond to this question due to lack of additional descriptive information.

36. PWS, Page 36, Optional Task 16: The PWS states that “the COR will provide the Contractor with a list of the materials available to the Contractor, including web application programming, data, programming, documentation and reports, and external data developed and procured under the outgoing contract.” For estimating purposes will the government please confirm: a) the list of anticipated GFE that will be provided to the contractor; b) the server infrastructure and hosting infrastructure that will transition to the new contractor; c) the software licenses that will be provided?

Answer: As stated in the PWS, material developed under the current contract will transfer to any subsequent contractor.

37. PWS page 37, Optional Task 18: Task states contractor may be required to perform each of the optional subtasks up to 2x/contract period. Does this mean 2 times during each contract year or 2 times during the entire 5 year period?

Answer: HRSA’s intention was for optional subtasks to be exercised up to two times each contract year.

https://www.srtr.org/requesting-srtr-data/saf-data-dictionary/