RFP Q and As.pdf

Questions & Answers for 75D301-23-R-72693 - HOPS

Q1. Per SOW p. 2, “All participating patients have signed informed consent forms that have been cleared by local and CDC Institutional Review Boards (IRBs)”. Does the signed informed consent include for the behavioral survey to be administered to patients via Telephone Audio-Computer Assisted Self-Interview

(T-ACASI), or a Web based Computer Assisted Self-Interview (W-CASI) as well?

Are these ongoing behavioral surveys different from the two anticipated additional surveys/enhanced data collection tasks per year?

A1. Yes, the signed informed consent covers the behavioral survey activities of T-ACASI and W-

CASI. Yes, the on-going behavioral surveys are different than the anticipated additional surveys. A

HOPS clinic site-level assessment is one example of an additional survey.

Q2. Per SOW, p.2 “The Contractor shall provide management of data collection and maintain quality control and data integrity”. Does the proposal need to show the data management plan? Is there a CDC template for data quality and integrity?

A2. Yes, the proposal must include a Data Management Plan (DMP) in the Technical Proposal

(does not count toward 24-page limit). Please refer to clause CDC100_0003, and provision

CDC100_0004 in RFP Attachment 2, Provisions and Clauses. A suggested resource for templates can be accessed at – https://www.cdlib.org/services/uc3/dmpt.html.

Q3. Per SOW, p. 4 Subtask 1.6: “Provide and execute a detailed continuity plan to seamlessly transition and maintain continuity and integrity of existing and newly collected longitudinal HIV medical abstraction data”. Will CDC or participating HOPS clinic sites facilitate that?

A3. The Contractor shall provide and execute a detailed continuity plan which includes the endorsement from existing HOPS clinic sites.

Q4. Per SOW, p.9 Task 5: Statistical Data Analysis, Subtask 5.1: “During each option period, the

Contractor shall provide statistical support for eight new and separate scientific analyses of the data specified above and contribute to the preparation of four scientific manuscripts for CDC clearance and journal submission”. Can CDC elaborate on the timelines for the separate data analysis and preparation of four scientific manuscripts for CDC clearance and journal submission?

A4. HOPS site Principal Investigators and CDC staff can propose new concepts and the

Contractor is required to support eight new research concepts each year. The Contractor provides statistical support and serves as a co-author. In each contract period, the Contractor contributes to the preparation of four scientific manuscripts for CDC clearance and journal submission, to include manuscripts that may have been started in earlier option periods.

Q5. Regarding IRB – for this contract period, are there any changes being made to the IRB review? Will the contractor pick-up from what has been done in the past (i.e., the review agency stays the same, no major issues that need to be remedied, etc.)?

A5. Current HOPS participating sites are covered either by CDC IRB or local IRB approval. IRB review process is subject to changes at CDC or local sites.

Q6. As HOPS has been going on for a long time, are previous participants eligible to re-enroll (or continue in the project with a lapse in participation). How do we handle a patient/participant that was enrolled in HOPS at a previous inactive site? Does the contractor have some sort of access or ability to check if someone has been previously enrolled in HOPS?

https://www.cdlib.org/services/uc3/dmpt.html

A6. HOPS is an open cohort. Previous participants are eligible to re-enroll if seen at a different

HOPS site. Local HOPS sites may be able to identify former HOPS participants.

Q7. Does the contractor have access to any HIV SMEs at CDC? This could be very helpful for the additional data collection activities and the data analysis.

A7. CDC HIV SME(s) will be assigned to the contract. Additional CDC HIV SMEs are available to be consulted, as needed.

Q8. For data analysis, does the contractor have access to previous years’ or achieved data?

A8. Yes, the contractor can access the full longitudinal data (1993-present) in SAS format.

Q9. What data capture tool will be used to store the medical records data? In the statement it says that the data is currently available with Open Clinica. Would you continue to use that tool for the data retrieved from the T-ACASI/ W-CASI behavioral survey data?

A9. Currently, existing HOPS medical records data, not behavioral survey data, are captured using open-source data collection and management software OpenClinica®. The Contractor shall continue to capture HOPS data using an industry comparable standard web-based medical record abstraction application.

Q10. Does the government have established performance measures for this contract?

A10. Contractor performance will be monitored and evaluated based on quality and timeliness of deliverables.

Q11. With regard to a Data Quality Plan, do you have identified core or required variables or a routine data quality plan?

A11. HOPS has established a list of required variables for data collection. Please refer to RFP

Attachment 4, HOPS Data Dictionary.

Q12. What Electronic Health Records (HER) systems is each medical practice site using?

A12. The EHR system varies by site. Some use Epic and some use Cerner.

Q13. The technical proposal instructions indicate a 12-page, double sided limit excluding cover page, table of contents, resumes, appendices, references, and the data management plan. For clarity, being that this is an electronic submission, the technical proposal page limit would be 24, single-sided pages, correct?

A13. Yes, the limit is twenty-four pages (exclusive of other specified material).

Q14. Can the technical proposal submission be emailed as a PDF?

A14. Yes, please submit via email in Word or PDF format.

Q15. Does each practice location already have an assigned data abstractor? If so, are these contracted staff by the current incumbent or full-time employees of the practice sites?

A15. Yes, each site already has at least one data abstractor. Some are contracted by the incumbent, and some are employees of the clinic sites.

Q16. Is it the expectation of CDC program staff that the company awarded this contract retain current data abstractors for the sake of continuity or produce new abstractors that will be assigned to each site?

A16. Either approach is acceptable. However, the retention of existing abstractors may be beneficial to continuity.

Q17. Resumes are only mentioned as not counting toward page count in the proposal submission. Can the government clarify if resumes are required? If so, shall we submit only key personnel and can we submit them as an appendix to the Technical Proposal?

A17. Yes, please submit resumes for Project Manager, Project Director, Software/IT specialist, Data manager, and Statistician positions. Resumes can be submitted as an appendix to the Technical Proposal.

Q18. Can the government confirm that the subcontracting plan is not required with the Business

Proposal since it will be submitted prior to the proposal due date via the SBCX platform?

A18. Yes, the subcontracting plan shall only be submitted via SBCX at the following – https://osdbu.hhs.gov/subcontracting/1a30a506-4e29-4503-9b02-0b36208bb344. The URL can also be found in the Description section for the RFP on SAM.gov.

Q19. Can the government confirm the subcontracting plan is due any time prior to 3:00 p.m. on

July 21, 2023?

A19. Yes, the subcontracting plan is due via SBCX any time prior to 3:00 p.m. Eastern

Time on 7/21/2023.

Q20. “References” are only mentioned as not counting toward page count in the proposal submission. Can the government confirm that, in the context of this solicitation, “references” is synonymous with “Similar Experience”?

A20. Yes, CDC confirms that “references” and “Similar Experience” are synonymous.

Q21. Subtask 6.4 – The government does not specify a due date for delivery of the transition plan. Please provide the due date.

A21. The Transition (phase-in) Plan is due within 30 calendar days of notice of award.

The two SAS deliverables under 6.4 are due within 45 days of contract completion. The

SOW has been updated to clarify and specify these details in the Deliverables Table.

Q22. Can the government ensure no other site has been added or removed since the last

HOPS contract? Is this the most current site list?

A22. Apex Family Medicine is no longer a HOPS clinic site. It has been replaced by

Washington Health Institute of Washington, DC. Attachment 3, “HIV Clinics” is now current on the SAM.gov RFP page.

https://osdbu.hhs.gov/subcontracting/1a30a506-4e29-4503-9b02-0b36208bb344