QA 5-5-22.pdf

SOLICITATION

# QUESTION ANSWER

1 Is there a deadline for submitting questions for this opportunity?

Yes, see “CDCA_L002 INQUIRIES (JUL 2017)” for detailed information.

2 Will the Government accept cost plus fixed-fee (CPFF) proposal submissions and/or fixed-price and/or time and material proposal submissions?

See FAR Clause 52.216-1 for procedures for proposing other contract types. This clause references the Exception procedures listed in Section L of the solicitation. Per these procedures, should the offeror wish to propose an exception to the terms and conditions of the solicitation, please provide the required information to allow the Government to conduct a thorough review of the proposed exception.

Please additionally note, that 52.216-1 states that the Government contemplates award of a Cost- Reimbursable type contract (the contemplation is not exclusive to a singular contract type under the Cost Reimbursable umbrella). As such both FAR Clauses 52.216-8 and 52.216-11 are included in the solicitation.

3 Is there an Excel available for submission of pricing?

No, offeror format for submission of Cost Data Information will suffice

4 To ensure offerors have time to prepare proposals that meet your expectations, will the CDC consider answering questions on a rolling basis (as opposed to responding to all questions collected on Wednesday, May 4)?

As a goal, the Government intends to turn around answers to questions as quickly as possible on a rolling basis.

5 Please confirm whether 2-pg resumes (requested in RFP section 4. Subfactor Four – Staffing Plan) are excluded from the total Technical Proposal 35-page limit.

CDCA_L011 provides guidance for pages excluded from the page count. This guidance is revised to exclude the resumes stated under Subfactor Four from the page count.

See solicitation Amendment 0001.

6 The RFP requires contractors to identify and recommend 15-30 healthcare facilities to enroll study participants (p.7, Task 3).

We know there are currently 17 domestic (U.S.)

institutions working with the incumbent, Vanderbilt. Does the CDC expect [to] continue with these institutions upon contract award? Or, would the contractor need to identify an additional 15-30 sites (i.e., ultimate management of a maximum of 47 sites)? If contractors should consider additional sites, should those be domestic only or would the CDC consider international locations?

The Government does not require specific healthcare facilities for the surveillance, but provides in Task 3 a standards-based, objective structure for the contractor to use in identifying, proposing and enrolling healthcare facilities. The RFP does not require specific healthcare facilities, but requires the successful contractor to provide its recommended list to CDC for final approval during the timing noted in the RFP.

Section C – Description and Specifications, Section 4, #3 Task 3 (b) is revised from:

“b. be geographically diverse and representative of the U.S. population and have a diverse population of patients with respect to sex, age, race, ethnicity, and underlying conditions” to:

“b. be geographically diverse and representative of the U.S. population, and have a diverse population of patients with respect to sex, age, race, ethnicity, and underlying conditions, and be a healthcare facility operating and enrolling patients for this surveillance within one of the fifty (50) states of the United States and the District of Columbia.”

(Revised text highlighted.)

See amendment 0001.

7 The RFP refers to an existing CDC-approved case-control protocol (p. 7, Task 4) and current IVY Network’s Standard Operating Procedures on specimen collection and shipment (p.9, Task 7b).

Will the CDC please provide these documents so non-incumbent offerors [in preparation of their proposal]? At [a] minimum, please provide the protocol synopsis.

Should an offeror require a copy of the current case-control protocol and/or current Standard Operating Procedures in preparation of a proposal, please submit a request to the Contract Specialist, Mark Draluck (syq1@cdc.gov), specifying the specific document(s) requested along with a copy of the completed and executed NDA located in Exhibit 1, below.

8 Is the evaluation of therapeutics (p. 10, Optional Task 10) part of the CDC’s current protocol/program?

No.

9 Please advise whether offerors should include specimen collection kits and shipping supplies in our proposals or whether offerors should assume those will be provided by the healthcare facilities (sites)?

Section C – Description and Specifications, Section 6 – Government Furnished Materials does not include government-supplied specimen collection kits and shipping supplies.

The offeror is responsible for providing all labor, materials, equipment and any other item for the successful performance of its proposed technical approach to meeting this requirement. Each offeror should provide sufficient technical descriptions of the specimen collection approach and strategy in its proposal.

10 Is sample testing currently performed at the site level? Or should offerors propose central labs services for the SARS-CoV-2 influenza, and RSV analysis?

Each offeror should propose its strategy for lab services for testing of SARS-CoV-2, influenza, and RSV in a technical manner that aligns to the offeror’s technical approach that meets the requirements stated in the RFP.

11 Will the selected contractor receive PBMC isolates or receive whole blood samples that they must isolate into PBMCs?

The selected contractor is responsible for designing a technical approach that meets the technical requirements as stated in the RFP. This requires the successful contractor to have the capability to receive whole blood samples and generate PBMC isolates either at its facility or through subcontracts.

12 Will the CDC expect the contractor to provide Ct values as part of reporting SARS-CoV-2 RT-PCR results?

Yes, see Amendment 0001.

13 Task 7(a) on page 9 of the RFP: The task states that the contractor will collect, store, and ship biospecimens. Should the contractor also budget for analyzing the biospecimens? The solicitation states, “The specimens will be used to evaluate susceptibility to severe infection and mechanisms of disease attenuation as well as vaccine failure and intrahost virus evolution.” We are reaching out for clarity on whether the contractor should plan to perform these laboratory analyses or simply send the specimens to CDC, where the laboratory

The contractor is responsible for analyzing the biospecimens.

See amendment 0002.

analyses will be performed outside of the contractor’s scope of work.

14 On page 6 of the RFP, under goal 5, the document says, “Submit all eligible SARS-CoV-2 respiratory specimens for sequencing to allow for sentinel genomic surveillance of hospitalized patients.”

Should the offeror propose to complete the sequencing laboratory work or simply ship specimens to CDC for the sequencing laboratory work to be completed outside the contractor’s scope of work and funding? That is, is the contractor responsible for providing the specimens only or provide both the specimens and the genomic sequencing results?

The contractor is responsible for providing specimens and genomic sequencing results.

See amendment 0002.

15 Will the offeror be responsible for contracting directly with the participating healthcare facilities?

If yes, how many healthcare facilities will be managed? Should estimated costs for the healthcare facilities be included in the business proposal?

The successful contractor is responsible for all work related to the assembly, operations, and management of the required observational, multicenter, prospective public health surveillance network aligned to the standards stated in the requirement, in the number included in the requirement, and to perform the work identified in the requirement. See revisions to Task 3 for further clarification issued under Amendment 0003.

16 Is there a target number of participants to be enrolled each year?

The number of participants enrolled is expected to fluctuate within and between years depending on the epidemiology of SARS-CoV-2, influenza, and respiratory syncytial virus. Based on past trends, the contractor has had to enroll, sample, and test at least 10,000 patients. This number reflected substantial circulation of these viruses which allow for stratified vaccine effectiveness analyses by age, race/ethnicity, and common underlying conditions. Emphasis is added because due to the inherent nature of the surveillance system and the potentially unpredictable circulation of the viruses, an actual number cannot be predetermined for this effort, but this number is a reasonable basis to utilize when generating your technical approach.

17 Must COTS EDC or biospecimen tracking systems be FEDRAMP certified?

All systems the offeror proposes, to perform any of the work stated in the requirement, must meet all terms and conditions stated in Section C (specifically Section 11) and the clauses and provisions included in the Solicitation

18 Is there an incumbent for this project? Yes.

19 The CDC funds several similar surveillance networks. Will this contract be a stand-alone network, or will the contractor be expected to collaborate with existing networks?

All information related to this contract is included in the Solicitation. This requirement is operationalized as a stand-alone requirement.

20 Task Area 7(a) (Page 9) – It is stated that the Government shall target 1000 participants for the Acute Sera biospecimen collection which is a subset of the overall enrollment population. What is the overall total target of enrolled participants in this study?

The answer to Question 16 above is incorporated by reference.

21 If a health system has multiple hospitals that qualify to participate in this trial, does each site count as 1 site or does the health system count as 1 site?

Each health system counts as one site.

22 Section L – Section 508 requirements (page 64) – Please advice whether offerors should submit a Section 508 Product Assessment Template with their proposal. If so, which volume should it be added to?

Please include this submission under “Other Administrative Data” within the Business Proposal Submission.

See clarification language in Amendment 0003.

23 Section L – CDC100_0004 – Data Management Plan (Pg 73) – Are offerors required to provide a Data Management Plan at time of proposal submission or only upon contract award? If the former, shall offerors include the Data Management Plan within the Technical Approach Volume and does it count towards the page limit?

Section L – CDC100_0004 – Data Management Plan (Pg. 73) states the following: “the offeror shall develop and submit a DMP as part of its proposal in response to this solicitation, and if awarded a contact update the DMP through the life cycle of the public health data collected or generated during the performance period.”

(Emphasis added).

This DMP submission shall be included within the Technical Approach Subfactor under “data collection and management process,” but will not count towards the Technical Proposal Factor page limit.

24 Section L – CDC0.L018 – Past Performance (Pg

71) – Section L states, “Offerors shall submit the past performance information as part of their business, technical or as a separate proposal. The offeror should include the last five (5) contracts completed during the past three (3) years and all contracts currently in process for both the offeror and all proposed major subcontractors. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers.”

Question 1) Must offerors include the ‘last’ 5 contracts completed (I.e., which may be unrelated to the requirements of this RFP), or should offerors select the most recent 5 contracts that have been completed that are relevant to this scope of work?

Question 2) Are the ‘last 5 contracts completed’ to be provided only by the offeror or is this required also for the major subcontractors? I.e., is it 5 references for the offeror and each of major subs, or is it 5 in total across the offeror and all major subs?

Question 3) Some offerors may be large businesses with hundreds of existing contracts, many of which are not related to this scope of work. Should offerors include this exhaustive listing or only include active contracts relevant to this requirement?

Question 4) As it is common for offerors to leverage related company capabilities in the execution of this type of work, can offeror

Please review the corresponding section M evaluation criteria for past performance when considering which performance record(s) to submit.

To answer your specific questions:

1) In accordance with paragraph (a) of this provision, the past performance submitted should be recent and relevant. Therefore, the last 5 contracts completed during the past 3 years should be those contracts relevant to this scope of work.

2) The offeror should include cumulatively five (5) completed contracts.

3) The past performance contracts submitted should be limited to those which are both recent and relevant.

4) In order to leverage contracts drawn from the offeror’s related corporate entities, the offeror must include supporting evidence of the planned relationship between the entities and how the corporate entity(ies) will meaningfully affect contract performance.

information provided for Past Performances including contracts drawn from offeror’s related corporate entities such as subsidiaries, parent/child companies, business units, etc?

25 Does the CDC expect the contractor to update the existing or develop new CRFs?

CDC expects the contractor to update the existing

CRF.

26 To ensure non-incumbent offerors propose accurate timelines, can the CDC please confirm whether current sites with Vanderbilt use a central IRB or local IRBs? If using a central IRB, can you please state which one, as various central IRBs have differing timelines?

This is a new contract and each offeror should align its technical approach to the identified phases and timelines as stated in the Solicitation.

How the incumbent contractor approached IRB approvals may not be workable within all conceivable technical approaches, specifically those proposed by other offerors.

To the extent that it is relevant, the current contract is supported by separate institutional review at each of the participating sites and the CDC.

27 Will the CDC please verify whether your next contractor would be responsible for modifying current site contracts when taking over site payments for services rendered on this contract?

Answer 15 is incorporated by reference.

CDC does not have privity of contract to any subcontracts in the current surveillance network, but all subcontracts in the current contract are between the incumbent contractor and the identified sites supporting that network.

28 Do we have to be a healthcare facility or a healthcare system to be considered for this opportunity?

Per M.1 of the solicitation, “A contract may be awarded to the offeror who is deemed responsible in accordance with the FAR, whose proposal conforms to the solicitation requirements, and is judged by an overall assessment of the evaluation factors and subfactors to represent the most advantageous to the Government.”

Please consult the solicitation requirements and evaluation factors and subfactors in determining your proposal strategy.

29 As it relates to Section L instructions and associated page limit, does CDC require Offerors to provide approaches and methods for accomplishing Section 11 – Special Considerations (Clearance Requirements) Deliverables 19(a-i) at the time of proposal, or are Offerors only to address in their proposals deliverables within the Section 4 – Tasks to be Performed and those called out in the Section 9 – Deliverables/Reporting Schedule Table?

Per CDC0_L012, “The technical proposal should be in as much detail as you consider necessary to reflect a clear understanding of the nature of the work being undertaken.” This clear understanding shall be demonstrated through the RFP factors and subfactors.

Specific to deliverables, for example, the scope of deliverables, technical subfactor 2 requires addressing all deliverables outlined in the PWS.

Note: Deliverables 19(a-i) are a subset of Deliverable 19 called out in the Section 9 Deliverable table

30 Per Section L, Offerors proposals must address approaches for development of the Site Data Management Plan (Deliverable 14, Site Data Management Plan). This deliverable references the broader CDC Data Management Plan requirement

See question 23 relative to the data management plan described in Section 11.

See question 29 relative to the Site Data Management Plan deliverable described in Section 11. Does CDC require Offerors to describe in their proposals how they accomplish both Data Management Plans within their proposal?

31 Section L, 52.216-1 Type of Contract (Page 63) – If an offeror decided to propose a Firm Fixed Price (FFP) contract type per the solicitation provision enumerated under FAR 52.216-1, would the solicitation evaluation criteria be modified to evaluate offerors with varying contract types?

Per FAR Provision 52.216-1, the Government contemplates award of a cost type contract. See clauses 52.216-8 (Fixed Fee) and 52.216-11 (Cost Contract-No Fee).

See Amendment 0004 which clarifies FAR Provision 52.216-1.

The Government will evaluate in accordance with the solicitation.

32 Section L, CDC0.L018 Past Performance Information, Sub-part (b) (Page 71) – To clarify, is the RFP asking for:

1) 5 total Past Performances covering contracts either completed in the last 3 years OR from the set of active contracts.

Or is the RFP asking for:

2) 5 Past Performances completed in the last

3 years AND a separate set of Past performance information for all active contracts?

i.e., is the government expecting two separate Past Performance sections (one for completed contracts and one for active contracts) or is the government expecting one Past Performance section (one listing/description with a total of 5 covering completed and active combined).

Answer 24 is incorporated by reference. Per answer 24, this submission should be limited to those projects relevant to this effort.

See Amendment 0004. The offeror shall submit no more than five (5) total past performance records.

33 Section L, CDC0.L018 Past Performance Information, Sub-part (b) (Page 71) – the RFP asks for (11) “Copies of the most recent Past Performance Evaluation issued to the offeror under each contract listed.”

For completed contracts it appears we can reference either a CPARS (if it exists) or a PPQ. For active contracts, is this same information required?

It will be challenging to get current customers to provide a formal performance rating via a PPQ if they have not already provided a CPARS.

Line (11) applies to both completed and active contract listings. Note Amendment 0004 which adds that this must be provided, if available

Please note RFP provision M.1(d)(4)(vii), “Pursuant to FAR 15.305(a)(2)(iv), in the case of an offeror without a record of past performance or for whom information on past performance is not available will not be evaluated favorably or unfavorably.”

EXHIBIT 1

CEN T ER S FO R D IS EA S E CO N T RO L A N D PR EV EN TIO N (CDC)

NO N-D IS C LO SU RE AG R E EM E NT

RFP # 75D30122R72124 (“RFP”)

RFP Descriptive Title: Surveillance of Acutely Ill Adults with Respiratory Viruses, including SARS- CoV-2

CDC Information Management Services (CIMS) Contract Domain: Information Management

Name of Offeror: ___________________________________________ (“Offeror”)

The Centers for Disease Control and Prevention has issued the RFP referenced above for services related to the surveillance of acutely ill adults with respiratory viruses, including SARS-CoV-2. The RFP references documents titled “Case Control Protocol” and “IVY Network’s Standard Operating Procedures on Specimen Collection and Shipment,” which the Government has not included in the RFP because it contains non-public, sensitive, confidential or proprietary information. The Government will release these documents to prospective offerors of this RFP if the offeror (1) represents that it intends to submit a proposal for the RFP, and (2) executes this Non-Disclosure Agreement (“Agreement”).

Offeror1 represents that it intends to submit a proposal for the RFP. Therefore, in consideration of the promises and covenants contained in this Agreement, the parties hereto agree as follows:

1. Confidential Information and Materials

a) "Confidential Information" shall mean any non-public, proprietary or procurement sensitive information that the CDC specifically marks and designates, either orally or in writing, as confidential or which, under the circumstances surrounding the disclosure, ought to be treated as confidential.

"Confidential Information" includes, but is not limited to, independent government estimates, independent costs and prices, product schematics or drawings, descriptive material, system specifications, software (source code or object code), and customer information, CDC's business policies or practices, information received from others that CDC is obligated to treat as confidential, and other materials and information of a confidential nature.

b) "Confidential Information" shall not include any materials or information which Offeror shows:

i. is, at the time of disclosure, generally known by or available to the public or became so known or available thereafter through no fault of Offeror; or

ii. is legally known to Offeror at the time of disclosure by CDC through independent means other than through work on a CDC-funded contract or task order, provided that Offeror shall have the burden of establishing such independent prior knowledge by competent written proof and/or evidence; or

iii. is furnished by CDC to third parties without restriction; or

1 As used herein, the term “Offeror” includes Offeror’s employees, consultants, parent, subsidiaries, affiliates or related parties owners, employees, staff and consultants.

iv. is furnished to Offeror by a third party who legally obtained said information and the right to disclose it; or

v. is developed independently by Offeror, through its employees, either before or after the term of Offeror’s engagement for Offeror’s own use and not for the use of the Government, where Offeror can document such independent development and use.

c) "Confidential Materials" shall mean all tangible materials containing confidential information, including without limitation drawings, schematics, written or printed documents, computer disks, tapes, and compact disks (CD), whether machine or user readable.

d) For purposes of this Agreement, “procurement-sensitive information” includes, but is not limited to, all information related to or arising from the documents referenced about including the RFP or any amendments; questions from potential offerors; non-public information regarding this procurement;

all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitation or award for this procurement; procurement data; contract information plans; strategies; source selection information and documentation; offerors’ identities;

technical and cost data; the identity of government personal involved in the acquisition; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

2. Restrictions

a) Offeror understands that it shall not disclose any Confidential Information to any other party without the prior written authorization of a CDC Contracting Officer. However, Offeror may disclose Confidential Information in accordance with judicial or other governmental orders, provided Offeror shall give CDC reasonable written notice at least seven (7) business days prior to such disclosure and shall comply with any applicable protective order or equivalent.

b) Offeror shall not use any Confidential Information or Confidential Materials of CDC specifically related to the above referenced documents for any purposes other than preparation of its proposal or a contract awarded to it in response to the RFP unless CDC provides prior express authorization or approval in writing.

c) Offeror shall take reasonable security precautions, which shall in any event be as great as the precautions it takes to protect its own confidential information, to keep confidential the CDC’s Confidential Information and the documents referenced above. Offeror may disclose Confidential Information or Confidential Materials only to Offeror's employees, staff or consultants on a need-to-know basis for the purposes of preparing Offeror’s proposal. Offeror shall instruct all employees, staff or consultants to which it gives access to the above referenced documents to maintain confidentiality and to refrain from making unauthorized electronic or hard copies. Offeror shall maintain appropriate written agreements with its employees, consultants, parent, subsidiaries, affiliates or related parties, who receive, or have access to, CDC’s Confidential Information in order for Offeror to comply with the terms of this Agreement.

d) Confidential Information and Confidential Materials may be disclosed, reproduced, summarized or distributed only in pursuance of Offeror's contractual relationship with CDC, and only as otherwise provided herein. Offeror agrees to segregate all such Confidential Materials from the confidential materials of others to prevent commingling.

3. Rights and Remedies

a) No provision of this Agreement is to be construed as making the above referenced documents or any information related to it public without restriction.

b) Offeror understands that by receiving the above referenced documents, it will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. Offeror acknowledges that it acquires no ownership interest in the above referenced documents released pursuant to this Agreement.

c) Offeror agrees to use the above referenced documents solely for purposes required in the preparation of its proposal in response to this RFP. Offeror agrees that it will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, company, entity or third party the above referenced documents or any information contained therein unless covered by an exception noted herein.

d) Offeror shall inform all employees, consultants or contractors of Offeror given access to the above referenced documents of the restrictions specified herein, and Offeror shall require that those parties be bound by this Agreement. Furthermore, Offeror represents that it will not release the above referenced documents information in any form to any of its employees, consultants or contractors unless it has confirmed and has the right to bind such parties to the restrictions specified herein.

e) This Agreement shall be construed, and the legal relations between the parties hereto shall be determined, in accordance with United States federal law for all purposes.

f) This Agreement is non-transferrable. Offeror shall not assign or otherwise transfer this Agreement.

Upon notice of award, Offeror shall certify to CDC that the above referenced document information has been destroyed and/or deleted from any electronic, physical or other file system in which the information can be stored or accessed.

g) CDC retains the right to terminate this Agreement, in the event that CDC determines that Offeror fails to meet the requirements of this Agreement. In the event of termination, Offeror shall immediately take such actions as are described in the preceding paragraph and certify that the above referenced documents information has been destroyed and/or deleted.

h) Offeror shall notify the CDC immediately upon discovery of any unauthorized use or disclosure of

Confidential Information or Confidential Materials, or any other breach of this Agreement by Offeror, and will cooperate with CDC in every reasonable way to help CDC regain possession of the Confidential Information and/or Confidential Materials and prevent further unauthorized use or disclosure.

4. Miscellaneous

a) All Confidential Information, Confidential Materials and procurement-sensitive information are and shall remain the sole and exclusive property of CDC.

b) All Confidential Information, Confidential Materials and procurement-sensitive information are provided "as is," and CDC makes no warranty regarding the accuracy or reliability of such information or materials. CDC does not warrant that it will release any product concerning which information has been disclosed as a part of the Confidential Information, Confidential Materials or procurement-sensitive information. CDC will not be liable for any expenses or losses incurred or any action undertaken by Offeror as a result of the receipt of the above referenced documents or any information related to it. The entire risk arising out of the use of this information remains with Offeror.

c) Offeror understands that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records.

d) This Agreement constitutes the entire Agreement between the parties with respect to the subject matter hereof. It shall not be modified except by a written agreement dated subsequent to the date of this Agreement and signed by both parties.

e) Unless a CDC Contracting Officer provides, none of the provisions of this Agreement shall be deemed to have been waived by any act or acquiescence on the part of CDC, its agents, or employees.

No waiver of any provision of this Agreement shall constitute a waiver of any other provision(s) or of the same provision on another occasion. Failure of either party to enforce any provision of this Agreement shall not constitute waiver of such provision or any other provisions of this Agreement.

f) This Agreement shall be construed and governed by the laws of the United States.

g) If any provision of this Agreement shall be held by a court of competent jurisdiction to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect. Should any of the obligations of this Agreement be found illegal or unenforceable as being too broad with respect to the duration, scope or subject matter thereof, such obligations shall be deemed and construed to be reduced to the maximum duration, scope or subject matter allowable by law.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their duly authorized representatives as of the date accepted by the Contracting Officer indicated below.

Executed on Behalf of Offeror: ___________________________________________________

By: _____________________________________________ Name: ___________________________________________ Position/Title:* ____________________________________ Email: ___________________________________________ Date: _________________ *Indicate your formal title if you are signing as an authorized representative on behalf of a company or entity. If you are signing as an individual, fill in the Title line as “individual”

Executed on Behalf of the Centers for Disease Control and Prevention

By: ________________________________________ Pellumbeshe Hoxhaj Contracting Officer & Team Lead Branch I, Team 1

CDC/OCOO/OFR/OAS

Date: _________________