RFP_N02CP71000-26_-_AMENDMENT_2_-_Questions_and_Answers.pdf

AMENDMENT 2

RFP N02CP71000-26

Support Services for Studies of Infection, Immunity and Cancer

Proposal due date: Remains the same 12:00PM EST November 7, 2016 Cut-off date for questions: Unchanged to 11:00AM EST October 25, 2016

1) Section Reference: SOW 6.d; Reference Text: “Perform routine laboratory tests…to be done locally for selected studies on a schedule to be determined by the COR...”

Question: Request more information, specifically can the offeror arrange for these tests to be done locally by another laboratory. And please explain what “locally” means-i.e., at the study collection site or at contractor facility?

Response: Yes, it is acceptable for the offeror to contract out laboratory work to a third party.

Locally means at the site where the study is being conducted.

2) Section Reference: SOW 6.e; Reference Text: “Perform other selected laboratory tests or assays”.

Question: Same as 6d question – can the offeror coordinate testing by contract laboratories.

Response: Yes.

3) Section Reference: Attachment 11 page 5; Project Manager description; Reference Text: The Project Managers should be experienced in developing data management systems…

Question a: We respectfully request that the Government confirm that the experience required for the Project Managers is correct as written – i.e. that the Project Managers are intended to be focused on data – e.g., Data Project Managers. On page 4, a non-key Database Manager is called out separately in the baseline labor mix. Please provide additional information to distinguish the role of the PMs from that of the separately named Database Manager.

Response: Thank you for noting this. The project manager him/herself does not require experience in developing data management systems if another member(s) of the team is experienced in doing so.

Question b: Please also clarify whether the description on Page 5 for the Project Managers is complete (that all relevant experience is stated). We would like confirmation that the Project Managers are not required to have any of the required experience listed for the senior Project Manager, as the descriptions are very different.

Response: Experiences listed as examples only and not meant to be all inclusive.

4) Section Reference: Attachment 11, page 2; B2; Reference Text: “Include a Staffing Plan with role descriptions of technical personnel and delineate lines of authority and areas of responsibility…”

Question: We respectfully request that the Government confirm that this requirement was intended in the Organizational Experience and Capabilities section. It is redundant with language found in the Personnel section requirements at the top of page 2. Please clarify.

Response: Agreed, this is redundant. Submit the Staffing Plan as requested under Section B.

Organizational Experience and Capabilities on Attachment 11, not under Personnel. You can submit as an appendix and reference the appendix number in your response.

5) Section Reference: Attachment 3 (SOW), page 4; Task 3a and b; Reference Text: “For protocols, data collection instruments,…the Contractor shall use word processing and graphics software that is compatible with that in use in IIB.” AND “For entry and management of data and computer files, the Contractor shall whenever possible, utilize currently available software and hardware systems rather than developing new systems. These systems may include…the NIH computer facility which shall be accessed by remote terminals…”

Question: We respectfully request that the Government provide more detail on:

1. Word processing and graphics software in use by IIB.

Response: Standard software such as Word, Excel, Powerpoint, GraphPad and Prizm are commonly used in IIB.

2. Currently existing data systems that may be used by the Contractor, including any to be accessed remotely via the NIH computer facility.

Response: The successful Contractor will have access to the BSI system which contains an inventory of all biological specimens associated with the various studies. The Contractor will need to have familiarity with this system to support activities linked to biospecimens in the studies.

6) Section Reference: Attachment 11, page 2; and L2.b. 1.b.4.; Reference Text: “Include for each named person a CV….”, and “resumes of all key personnel are required”.

Question: We respectfully request that the Government clarify whether CVs are required only for Key Personnel (PD and PMs) or for all named technical personnel including subcontracotrs and consultants.

Response: CVs are required for all technical personnel being proposed including subcontracotrs and consultants.

7) Section Reference: M.6.A.1, page 94; Reference Text: “Ability of study managers to attend face to face meetings between key contract staff and the NCI COR or study investigators.”

Question: The labor category, study manager, does not appear anywhere else in the RFP. Please clarify whether the study manager position is synonymous with either the Senior Project Manager or Project Manager positions included in Senior Personnel. If the study manager position is a unique labor category within Other Personnel, please provide information on the required experience and qualifications, and role/responsibilities so that we may accurately address the referenced evaluation criteria.

Response: The Study Manager is synonymous with the Project Manager. Both Senior Project Managers and Project Managers might be required to attend these meetings, depending on the nature of the meeting and its complexity.

8) Section Reference: Attachment 11, page 1; Reference Text: “The Offeror must adhere to a 120-page limit. Pages in excess of this limitation will be removed from the proposal and will not be provided to the reviewers to be read or evaluated… The 120-page limit excludes the cover sheet, resumes, all appendices or attachments and the Offeror’s response to the Statement of Work.”

Question: Please clarify what is, and is not, included in the 120-page limit. The exclusion of the “Offeror’s response to the Statement of Work” from the page limit is particularly confusing.

Response: Things like your cover sheet, resumes/CVs, an Offerors appendices or attachments are excluded from the 120-page limit. The Offereror’s response to the Statement of Work is included in the 120-page limit.

9) Section Reference: Attachment 11, page 1: SECTION 1: COVER PAGES AND TABLE OF CONTENTS;

Reference Text: “A. PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, DUNS number, proposal part, and identify if the proposal is an original or a copy;

B. PROJECT OBJECTIVES;

C. GOVERNMENT NOTICE FOR HANDLING PROPOSALS;

D. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043);

E. TABLE OF CONTENTS. Include a Table of Contents with indicated pages of proposal sections that at a minimum uses the underlined Headings and Subheadings that appear below.

Additional subheadings may be entered at the Offeror’s discretion.”

Question: Will any of the content described under “SECTION 1: COVER PAGES AND TABLE OF CONTENTS” count against the 120-page limit?

Response: With the exception of Project Objectives, none of the items described are included in the 120-page limit.

Question: Please clarify letter B under “SECTION 1: COVER PAGES AND TABLE OF CONTENTS.”

Does “PROJECT OBJECTIVES” refer to an executive summary? Or a restating of the objectives as the offeror understands them? Or perhaps something else?

Response: See Page 64 in the RFP a.1. Statement of Work Objectives.

Question: Please provide the “Government notice for handling proposals” as referenced in letter C.

Response: Please disregard item C.

10) Section Reference: Page 52, paragraph 12. Past Performance Information: Reference Text: “a.

Offerors shall submit the following information as part of their Business proposal. A list of the last 3 contracts completed during the past Three years and THE LAST 2 CONTRACTS AWARDED currently being performed that are similar in nature to the solicitation work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a "major subcontract" is defined as $250,000 or more.”

Question a: Please clarify the difference between the “last 3 contracts completed” and “THE LAST 2 CONTRACTS AWARDED currently being performed.” Does this mean a list of five, unique, past contracts must be submitted? Or can these lists be the same/overlap?

Response: Refer to Amendment 1, Item #1 posted on FBO.

Question b: May major subcontractor past performance information count towards the past performance requirement as described on page 52, paragraph 12? Or only in addition to the requirement?

Response: Yes.

Question c: Can grants count toward this requirement, or must the past performance information provided only refer to contracts?

Response: No grants, only contracts.

11) Section Reference: Page 88, paragraph d. Pertinent Contracts: Reference Text: Pertinent contracts is defined as a listing of each related contract completed within the last three years or currently in process. The listing should include: 1) the contract number; 2) contracting agency; 3) contract dollar value; 4) dates contract began and ended (or ends); 5) description of contract work; 6) explanation of relevance of work to this RFP; 7) actual delivery and cost performance versus delivery and cost agreed to in the contract(s). For award fee contracts, separately state in dollars the base fee and award fee available and the award fee actually received. The same type of organizational experience and past performance data should be submitted.

Question: Please clarify the difference between the “Past Performance Information” requested on page 52 and the “Pertinent contracts” requested on page 88. Should the offeror include this information twice in their business proposal or should the offeror assume Past Performance Information is the same as the Pertinent Contract information?

Response: Refer to Amendment 1 , Item #1 posted on FBO.

12) Section Reference: Page 94, Section B. ORGANIZATIONAL EXPERIENCE IN CONDUCTING AND

SIMULTANEOUSLY MANAGING LARGE, MULTIPLE MOLECULAR EPIDEMIOLOGIC STUDIES

(DOMESTIC AND INTERNATIONAL) (25 POINTS); Reference Text: “This includes all field activities, including those associated with collection of biologic specimens.

Demonstrate experience in survey research design/development and the development/conduct of field and molecular epidemiologic studies by the Offeror relevant to this procurement.

Provide three references documenting your successful past performance in the conduct of similar studies. The documentation must include the title of the study, contract or ID number, a brief summary of the work performed, the names of both the technical and business contacts, their phone numbers, and either their FAX number or email address.”

Section Reference: Attachment 11, page 2, Section B.3; Reference Text: “Demonstrate experience in survey research design/development and the development/conduct of field and molecular epidemiologic studies by the Offeror relevant to this procurement. Provide three references documenting your successful past performance in the conduct of similar studies. The documentation must include the title of the study, contract or ID number, a brief summary of the work performed, the names of both the technical and business contacts, their phone numbers, and either their FAX number or email address.”

Question: Please clarify the difference between the past performance information requested in the Business Proposal (Page 52, paragraph 12. Past Performance Information) and that requested in the Technical Proposal (two quoted passages above). Should the contracts/studies referenced in each be the same? Will all past performance information in both the Business and Technical Proposals be evaluated “subsequent to the technical evaluation” per page 96 of the RFP? Or will each be evaluated against different criteria?

Response: Refer to Amendment 1, Item #1 posted on FBO.

13) Section Reference: Page 65, paragraph b. Personnel; Reference Text: “Describe the experience and qualifications of personnel who will be assigned for direct work on this program.

Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program…

Reference Text: Single Principal Investigator/Project Director: List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible.

Reference Text: Other Investigators: List all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments.

State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.

Reference Text: Additional Personnel: List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement. Commitment letters for use of consultants and other personnel to be hired must include:

• The specific items or expertise they will provide.

• Their availability to the project and the amount of time anticipated.

• Willingness to act as a consultant.

• How rights to publications and patents will be handled.

Reference Text: Resumes: Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

Section Reference: Attachment 11, page 2, Section A: Personnel: Reference Text: “The Technical Proposal should include all information relevant to document individuals’ training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements. The Technical Proposal should include a Staffing Plan with role descriptions of key technical personnel. Include the highest degree, organizational affiliation (employer) and percentage of effort to be committed to the project, including technical personnel of all proposed subcontractors and consultant personnel. Include for each named person a Curricula Vitae (CV), that is limited to 2-3 and include experience with projects of similar scope, size and complexity.

Reference Text:

1. Project Director: Describe the education, training, experience, expertise, qualifications, and percentage of effort of the proposed Project Director to lead and direct the activities to be carried out under this contract. The qualifications and experience of the Project Director should be discussed in terms of 1) how they are appropriate to the management of any planned subcontract and consultants; 2) managing and coordinating the efforts of personnel required to perform functions described in the Statement of Work; 3) how the technical planning and implementation of Tasks will be managed by the Project Director.

2. Other Personnel: Describe the education, training, experience, expertise, qualifications, role in the project, and percentage of effort for all proposed scientific and technical personnel of the Offeror and any proposed subcontractors and consultants. Document relevant qualifications for:

medical record abstracting, computer programming, and data collection and all other areas of the Statement of Work.”

Section Reference: Attachment 11, page 4: Additional Information

Reference Text: “The Government estimates that, as a baseline, the labor mix of the key personnel required to provide the level-of-effort required for this contract shall include approximately 1 Project Director, 3-4 Project Managers/Senior Project Managers, 1 Database Manager, 1 Biological Specimen/Laboratory Specialist, 1-2 Research Assistants/ Administrators, and other field personnel as needed (interviewers, coders, phlebotomists and abstractors). The key personnel are the Project Director and Project Managers.”

Question: Please clarify which positions require candidates to be named and which positions require CVs to be submitted. There is language in the RFP that states “Resumes of all key personnel are required.” But there is also language that states “Include for each named person a Curricula Vitae (CV), that is limited to 2-3 [pages] and includes experience with projects of similar scope, size and complexity.”

Response: All technical personnel require a CV. At a minimum this would include the Project Director, the Project Managers, the Database Manager, and the Biological Specimen/Laboratory Specialist and any other labor categories you propose performing technical functions that may not currently be listed.

14) Section Reference: Page 93, Paragraph 6.A. PERSONNEL (45 POINTS): Reference Text: 1.

EXPERIENCE AND CAPABILITIES OF OTHER PERSONNEL (20 POINTS)

• Other field personnel required for the conduct of the described variety of field studies. This includes but is not limited to: abstractors, interviewers, keyers, coders and phlebotomists (evidence of experience and training in the conduct of similar studies, demonstrating the above capabilities using their own personnel).

• Other mid-level personnel required for the conduct of the described variety of field studies.

This includes but is not limited to: interviewer supervisors, coding supervisors, data entry supervisors, telephone center supervisors, and other mid-level personnel (evidence of experience and training in the conduct of similar studies, demonstrating the above capabilities using their own personnel).

• Other personnel required for the conduct of the described variety of field studies. This includes but is not limited to: forms designers, statistical sampling design specialists, nosologists, nutrition specialists, coding specialists in specific areas such as therapeutic drugs, occupations, industries, etc., software development specialists (evidence of experience and training in the conduct of similar studies, demonstrating the above capabilities using their own personnel).

• Computer Programmers/analysts (including a range of computer analysis abilities, from the use of large databases to construction of analytic data files, to analyses using programs such as SAS on the personal computer) (evidence of experience and training in the conduct of similar studies, demonstrating the above capabilities using their own personnel).

• Ability of study managers to attend frequent face-to-face meetings between key contract staff and the NCI COR or study investigators.

Section Reference: Attachment 11, page 4: Additional Information; Reference Text: “The Government estimates that, as a baseline, the labor mix of the key personnel required to provide the level-of-effort required for this contract shall include approximately 1 Project Director, 3-4 Project Managers/Senior Project Managers, 1 Database Manager, 1 Biological Specimen/Laboratory Specialist, 1-2 Research Assistants/ Administrators, and other field personnel as needed (interviewers, coders, phlebotomists and abstractors). The key personnel are the Project Director and Project Managers.”

Question: Please clarify the personnel requirements beyond the key personnel. The quoted sections of the RFP above list a wide variety of “other personnel.”

Response: The offeror should review the summary of ongoing projects and determine the personnel mix they believe will be required.

15) Section Reference: Attachment 11, page 2, section A; Reference Text: “The Technical Proposal should include all information relevant to document individuals’ training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements. The Technical Proposal should include a Staffing Plan with role descriptions of key technical personnel. Include the highest degree, organizational affiliation (employer) and percentage of effort to be committed to the project, including technical personnel of all proposed subcontractors and consultant personnel. Include for each named person a Curricula Vitae (CV), that is limited to 2-3 and include experience with projects of similar scope, size and complexity.”

Section Reference: Attachment 11, page 2, section B.2; Reference Text: “Include a Staffing Plan with role descriptions of technical personnel and delineate lines of authority and areas of responsibility. Include the highest degree, and percentage of effort to be committed to the project, including technical personnel of all proposed subcontractors and consultant personnel.

Section Reference: Attachment 11, page 4, section C.b); Reference Text: “A management plan delineating the responsibilities of proposed staff.”

Section Reference: Attachment 17, page 1, Section 3.1; Reference Text: “Labor: As a baseline, the labor mix of the key personnel required to provide the level-of-effort required for this contract shall include approximately 1 Project Director, 2-3 Project Managers/Senior Project Managers, 1Database Manager, 1 Biological Specimen/Laboratory Specialist, 1-2Research Assistants/Administrators, and other personnel as needed (interviewers, coders, phlebotomists, translators, abstractors, etc.).

Question: Please clarify which sections of the technical proposal require the inclusion of a staffing plan. Can the staffing plan be included as an appendix but then referenced in each section of the technical proposal where it is required to be included?

Response: Refer to response submitted under #4 above.

16) Section Reference: Page 49, paragraph 4. Separation of Technical and Business Proposal:

Reference Text: The proposal must be prepared in two parts: a "Technical Proposal" and a "Business Proposal." Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

The technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the offeror's understanding of the project may be evaluated (See SECTION J, Attachment entitled, TECHNICAL PROPOSAL COST SUMMARY.) However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs. The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions.

Question: Please clarify what cost elements should be included in the technical proposal, particularly those related to rates/salaries. The language quoted above states, “The technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates,…” and “However, the technical proposal should not include pricing data relating to individual salary information,…” Additionally, in what format should the cost elements included in the technical proposal appear? Excel document? Table? Written (budget narrative)?

Response: See Attachment #7 of the RFP and follow the instructions.

17) Section Reference: Attachment 11, page 1; Reference Text: “These Additional Technical Proposal instructions reflect the requirements of the Request for Proposal (RFP) and provide specific instructions and formatting for the Technical Proposal. While Section L.2.b. of the RFP provides general Technical Proposal instructions, these Additional Technical Proposal Instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used, along with Section L. to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal.”

Question: Given the contradictory nature of some of the instructions provided in Attachment 11 versus Section L and M of the main RFP, please clarify which list of instructions offerors should defer to in case of contradictions: Attachment 11? Or Section L and M?

Response: All contradictory instructions should be clarified in either Amendment 1 posted October 24, 2016 or the current Amendment 2. Section L is meant to provide instructions to offerors; Attachment 11 includes additional instructions to offerors that may not be included in Section L. Section M provides the offerors the evaluation criteria upon which the Government will use to evaluate each proposal submitted. It is not the Government’s intent to provide contradictory or duplicative information.

18) Section Reference: Page 88, Business Proposal Instructions, Paragraph 10: Subcontractors:

Reference Text: “If subcontractors are proposed, please include a commitment letter from the subcontractor…”

Section Reference: Attachment 11, page 1, SECTION 2: TECHNICAL DISCUSSIONS: Reference Text: “The Offeror shall submit a proposal that addresses the Tasks in the Statement of Work. If the proposed approach will involve a subcontracting arrangement, then the Offeror shall include a letter(s) of commitment from the subcontractor(s),…”

Question: Please clarify where the subcontractor letter(s) of commitment should appear:

offeror’s technical proposal or business proposal?

Response: Subcontractor letter(s) of commitment should be submitted with the technical proposal.

19) Section Reference: Attachment 11, page 3, Paragraph D.h); Reference Text: “The approach to a transition of responsibilities to a new Contractor for: 1) on-going data collection, 2) maintenance of data management systems for ongoing studies, 3) plans for transfer and documentation, 4) plans for transfer and documentation of biologic materials. It is expected that the transition will take no more than four weeks. If additional costs are expected to be incurred to cover the task of transition, these costs should be identified in the Business Proposal as a separate line item of cost.”

Question: Please clarify what offeror’s should develop plans for the transfer and documentation

of. It appears #3 is incomplete.

Response: Item 3) is revised to read: “plans for transfer of study-specific documentation”.