Amendment 7 - Q_A.pdf

DHS RFP 70RDAD20R00000012

Amendment 7

Questions and Answers

Q# Question Answer 1 Will DHS handle required CDC and State-level COVID results test reporting / contact tracing info OR does DHS request that Offerors handle this task?

DHS requires reporting in accordance with the CARES Act. Please see Section 7.9 of the revised

RFP.

2 Is an entity that is neither a “covered entity” nor a “business associate” (as defined by and subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA)) eligible to respond to this RFP?

Yes, proposals may be accepted from an Offeror without regard to their designation as a Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) "covered entity." Please see RFP Section 11: Instructions to Offerors.

3 Section 4 5 (Computing Requirements) - "The contractor shall be able to accept anonymized patient data to enroll individuals to be tested into a testing queue from Government Systems" Could the DHS please clarify this statement? There are State and Local health department data collection requirements for COVID-19 tests which includes patient name

DHS requires reporting in accordance with the CARES Act. Please see Section 7.9 of the revised

RFP.

4 The RFP states, “The contractor shall be able to accept anonymized patient data to enroll individuals to be tested into a testing queue from Government Systems ” Could the government please clarify this statement? There are State and Local health department data collection requirements for COVID-19 tests which includes patient name

DHS requires reporting in accordance with the CARES Act. Please see Section 7.9 of the revised

RFP.

5 Does LIMS need prior government clearance? No, a Laboratory Information Management System (LIMS) does not need prior government clearance.

6 Will positive test results be required to be sent to the Dept of Public health?

DHS requires reporting in accordance with the CARES Act. Please see Section 7.9 of the revised

RFP.

7 Can you point me to how we can tender and supply an official offer for our test kits please?

All instructions for submitting a proposal are included in RFP Section 11: Instructions to Offerors. Please read the solicitation in its entirety, including all amendments to the solicitation, and be sure to follow all proposal instructions in the RFP. Late or incomplete proposals will not be evaluated or considered for award.

8 We just learned about this RFP and are interested in understanding whether anything had to be submitted prior to this week's July 29th deadline or whether we would still be able to submit something. We are also interested in better understanding whether there will be opportunities for subcontractors since this is such a big endeavor.

There are no pre-proposal requirements or notices to the Government required. All instructions for submitting a proposal are included in RFP Section 11:

Instructions to Offerors. It is the responsibility of offerors to form teams/subcontracting arrangements, if they wish to do so.

9 Our company would like to provide testing to the U.S. Dept.

of Homeland Security but require a firm quantity amount listed before we are able to respond to this opportunity. We kindly request this information to be incorporated to the solicitations so that we can determine if we can meet the requirements.

We cannot provide an estimated quantity at this time.

The award is expected to be a multiple-award DHS-wide IDIQ; it is therefore also not possible to accurately predict how many kits will be required per order or vendor. The ceiling limit for all orders placed under the IDIQ is $2 billion.

10 Please consider this an official request that this solicitation is set-aside for HUBZone, Total Small Business, Black- Owned businesses.

The IDIQ competition is unrestricted. Set-asides may be completed at the order level. Please see Section 6.10.

11 We would like to inquire about the possibility of using DoD SAFE platform for submission of our proposal for the subject referenced Solicitation, because sometimes we are facing difficulties and some emails with attachments do not reach your end.

DHS will not be utilizing DoD platforms for proposal submissions.

12 Can you tell me where the SF1449, SF30’s and Reps & Certs go in the package? Will they go in the price proposal?

If so, do you want them at the front of the packet or back?

These documents shall be submitted separately from the Price Proposal. Final document submission requirements have been revised via Amendment 7, see Section 11: Instructions to Offerors.

13 Are you still in need of testing supplies such as tubes, reagents, VTM, or nasopharyngeal swabs? Can we submit pricing for these items individually or only as a kit?

Providing a proposal for these supplies alone does not qualify as a complete proposal and will not be eligible to receive an IDIQ contract award. All FCs require a full solution for testing (not just test kits). The full solution includes, the test kit, all the necessary components (transport media, the reagents needed to run the test, etc.) to collect samples and successfully transport them to the laboratory where the test is run.

The offeror is also required to provide lab processing, the test results and reporting. Please see Section 11 for pricing instructions.

14 How many Attachment As would you expect to see from a contractor responding to all 3 FC? Two or three?

It is still unclear if you would like to see a separate Attachment A for FC1, or would you just expect to see Attachments A for FC2 and FC 3 with the additional 3 questions in the bottom.

Three. Offerors shall submit a separate Attachment A for each functional category (FC) they propose. For example, if an offeror is proposing a solution for FC2 and a solution for FC3, then the offeror shall submit 2 Attachment As. The offeror information table does not have to be duplicated, but the offeror name, kit type and any information that may be different for the two kits must be included on the additional Attachment A. Please do not include external links to websites or videos in your responses to the Attachment A questions

15 In your instructions, for FC 1, you have referred contractors to RFP Section 11: Instructions to Offerors, Paragraph

3.2.2.1 for instructions, but these are pricing instructions, it is not clear what should be reflected in the non pricing/capability section of Volume II with respect to FC1.

All non-pricing requirements are also identified in RFP Section 11: Instructions to Offerors.

16 Is this tender for full covid19 testing as well or is it just for the COVID19 test kits?

This solicitation is for a full testing solution, not just test kits. FC 1 requires contractor staffing for the sample collection, FC 2 & 3 do not.

With the exception of staffing to collect the sample, all FCs require a full solution for testing (not just test kits). The full solution includes, the test kit, all the necessary components (transport media, the reagents needed to run the test, etc.) to collect samples and successfully transport them to the laboratory where the test is run. The offeror is also required to provide lab processing, the test results and reporting.

17 We supply the actual Pharmaceutical testing kit ( rt-PCR) Can you please advise or put us in the direction of which organizations / laboratories we should be aligning our products directly ?

The government cannot advise the offeror on how to structure their proposal or business arrangements.

18 Do you expect 3 Attachments A by offerors responding to all 3 FCs or 2 Attachments A with the 3 additional questions answered at the bottom.

If the contractor is proposing multiple tests duplicate offeror information tables aren’t required. For the additional kits, ensure that the offeror name, kit type and any information that may be different for that kit is included in the offeror information table. The vendor is still required to submit a separate Attachment A for each functional category but is not required to duplicate the offeror information table.

19 Can you please explain why the due date for the COVID-19 Testing Services keeps getting moved forward each week?

Please see Amendment 6 and the final conformed solicitation. No further explanation can be provided.

20 Being that DHS continues to push submission date out, are we expected to continue to apply to have FDA continue to sign EUA within 7 Days of submission each time submission date is pushed out? Or will a previously dated EUA within last month be acceptable?

FDA EUA approval shall be dated no later than one week (7 calendar days) prior to the submission date of the proposal; therefore, the Government will look at the submission date, not the proposal due date.

21 Where would DHS like the following:

a. FAR 52.252-1 SOLICITATION PROVISIONS

INCORPORATED BY REFERENCE

b. SF30's for amendments Are we able to put both a. & b. above in an appendix?

Final document submission requirements have been revised via Amendment 7, see Section 11: Instructions to Offerors.

22 Will there will be a pre-bid call/meeting for this solicitation. RFP Amendment 3 includes the audio and PowerPoint of the Industry Day held on July 9, 2020.

23 We have received the bid for COVID-19 testing however it looks like the bid is for onsite testing at the various DHS locations? We can perform COVID-19 testing at any of our medical centers throughout the country, however we do not

Submitting a proposal that only allows for testing to be done at contractor locations will not meet the requirements of this solicitation. All FCs require a full solution for testing (not just test kits). The full currently have the staff to perform onsite/offsite COVID testing. Do you know if there would be any interest from DHS to utilize our clinics for testing at our facilities?

solution includes, the test kit, all the necessary components (transport media, the reagents needed to run the test, etc.) to collect samples and successfully transport them to the laboratory where the test is run.

The offeror is also required to provide lab processing, the test results and reporting.

24 We have a rapid antigen test which is being submitted to the FDA and meets their criteria. We expect to have an EUA by the end of September based upon FDA feedback. Is it possible to bid item 3, antigen testing with a pending FDA submission?

No, FDA EUA approval shall be dated no later than one week (7 calendar days) prior to the submission date of the proposal.