Amendment 6 - SF30 and Q_A.pdf

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70RDAD20R00000012

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1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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Washington DC 20528-0115 Attn: Nikolai Matoka

DHS/OPO/DEPT.OPS

245 Murray Lane, SW, #0115 Dept. Operations Acquisition Div.

Office of Procurement Operations U.S. Dept. of Homeland Security

07/28/20200006

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

06/22/2020

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not, is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this solicitation amendment is as follows:

a. To extend the solicitation response due date from July 29, 2020 at 12:00 PM Eastern Time

(ET) to August 12, 2020 at 12:00 PM ET.

b. To provide Government responses to vendor questions. Multiple questions are still pending Government review and responses will be provided via a forthcoming amendment to the solicitation. The pending questions are with regard to reporting requirements and the

Health Insurance Portability and Accountability Act (HIPAA).

All other terms and conditions remain unchanged.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

Carrie Herndon

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

NSN 7540-01-152-8070

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

TEL: EMAIL: carrie.herndon@hq.dhs.gov

DHS RFP 70RDAD20R00000012

Amendment 6

Questions and Answers

Q# Question Answer 1 RFP Instructions 3.1.1. FDA or FDA EUA Certification

Verification: If a contractor chooses to only bid on Functional Category 1, which is the staffing to administer the test, would the FDA or FDA EUA Certification be required? If certification is required, what would DHS like the contractor to have certified? If this is not required, how should the contractor respond to this requirement.

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.

Yes, test kits proposed as part of an FC 1 proposal will need to have FDA authorization or EUA, please see RFP Section 11: Instructions to Offerors, Paragraph 3.2.2.1 for instructions.

2 The DHS website states: "COVID-19 Pandemic Temporary Credentialing Procedures The DHS Office of the Chief Security Officer (OCSO) is committed to protecting our workforce during the COVID-19 pandemic. To support social distancing requirements, OCSO is offering an alternate DHS credential known as a Derived Alternate Credential (DAC) to employees in lieu of a DHS Personal Identity Verification (PIV) credential so that personnel can still gain logical access to the DHS network without visiting a DHS Credentialing Facility (DCF). Personnel who obtain a DAC will have to get a DHS PIV Card later."

If the government requires a HSPD-12 clearance for personnel, can the contractor assume that we will be able to work with the government and utilize the DAC process

This may be the case at the order level. Order level details will be provided in task order requests for proposals (TORP).

established as part of the pandemic to be able to quickly administer the services.

3 For FC 1, will the contractor be required to supply more than one onsite collection location?

Yes, collection locations will be stated in TORPs. Due to the fact that DHS anticipates a multiple-award IDIQ, IDIQ contract holders are obligated to submit a proposal on each TORP.

4 For FC 1, can the collection staff be contracted by the company for the purpose of collection? Is collection staff required?

Yes, subcontractors shall be identified in the offeror's proposal. Collection staff is required for FC 1, as described in SOW 4.1.

5 How many test kits are you looking for and what are the requirements of the kit?

Specific quantity requirements will be identified at the order level in the TORP. The kit requirements are stated in Section 4.0 of the SOW. The ceiling limit for all orders placed under the IDIQ is $2 billion.

6 I have a large supplier for testing kits but I do not have the ability to do the testing. Am I still able to submit my info for just the test kits?

No. 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.

7 We would be interested in participating as a sub-contractor for the IDIQ Notice No.70RDAD20R00000012, or in submitting in a separate RFP to provide these products. Can you please advise on the best way to do that?

We cannot provide business recommendations to contractors; however, the beta.sam.gov post for this requirement includes an "Interested Vendors" section that contractors may utilize if they are logged in to beta.sam.gov.

8 What is the total number of employees of the DHS? Approximately 240,000.

9 How many DHS locations are there? A reasonable estimate cannot be provided. Each

TORP will identify the specific location for the individual requirement.

10 How many, and where are the locations outside of the continental United States (OCONUS)?

A reasonable estimate cannot be provided. Each TORP will identify the specific location for the individual requirement.

11 Is the testing projection consistent with Attachment B (500 individuals per day between the hours of 9 am and 3pm)?

No. The scenario does not reflect an actual requirement and is only used for price evaluation purposes.

12 Will employees be tested on an ongoing basis? If so, what is the frequency (weekly, monthly, etc.)?

A reasonable estimate cannot be provided. Each TORP will identify the specific requirements.

13 Please confirm testing is sought for both symptomatic and asymptomatic individuals.

DHS may test individuals who are pre-symptomatic, asymptomatic, or symptomatic.

14 Does the DHS have access medical providers, either staff or otherwise, that may be leveraged for observing specimen collection? If so, please indicate any limitations.

Yes; however, this varies by location and cannot be estimated at an agency-wide level. Each TORP will identify the specific requirements.

15 RFP FC 2 states, “Tests that detect the presence of one or more SARS-CoV-2 proteins indicating the presence of virus.” Please confirm that tests, such as RT-qPCR, which detect the viral RNA that becomes viral protein meet this requirement.

If you are proposing a RT-qPCR test, the probes for the RT-qPCR must be specific for SARS-CoV-2 virus. We are looking for the presence of the circulating virus, not an antibody test.

Proposing only test kits or elements of test kits will not meet the solicitation requirement. RFP Section 2, Paragraph 3.0 Scope states: For all testing solutions and functional categories, the government requires all the components necessary to administer the tests and for the results to be provided, to include any swabs or collection tools, test cassettes, devices to process tests results on-site or laboratory processing capabilities, transport media (if necessary) that does not impact test efficacy, and medical waste disposal.

16 We provide the full platform (cloud-based) for testing, highlighted below:

1. Ability to perform PCR SARS-CoV-2 testing on saliva without the need for a swab.

2. Saliva collection to be performed without observation or assistance from a healthcare professional (At-Home Collection)

FC 1 (Managed Testing Services) 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

3. Turn-Around-Time (TAT) of <72 hours from receipt of specimen.

4. Meet the required government security protocols.

5. Provide a copy of the professional certification and/or license of the Laboratory and/or Medical Director.

6. Provide a copy of their CLIA certificate.

7. Provide a cloud-based system to order and retrieve results.

8. Provide sufficient quantity of collection kits to perform contracted work.

10. Quality Assurance/Quality Control Program.

11. Ability to electronically bill and to accommodate multiple lines of accounting.

a. Would this be accepted as a managed service option?

or,

b. Do you require on-ground personnel to be eligible for managed services?

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 I want to confirm that the solicitation is still open and we can submit a proposal.

Yes, the current proposal due date/time is August 12, 2020 at 12:00 PM Eastern Time. Please continue to monitor the beta.sam.gov post which states the due date/time. 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.

18 Was just inquiring, if you are still looking for testing solution at different locations?

Yes, as identified in the RFP SOW Scope, "As defined in individual orders, COVID-19 testing solutions shall be deployable to support DHS in the continental United States (CONUS), outside of continental United States (OCONUS), and U.S.

territories. The Contractor shall furnish the necessary equipment, supplies, personnel, materials, travel, and other services required to satisfy the ordered testing solution requirements." 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.

19 Trying to get clarification if DHS is looking for Rapid response tests. My company supplies a Rapid test that is 98% effective for antibody detection in 10 minutes.

DHS is not currently seeking antibody testing.

20 Our lab provides PCR testing services, and I noted in the RFP that multiple types of testing services were listed. I wanted to clarify whether the contract required that we provide all of these services, or if it was possible for us to offer our services for just one of the testing methodologies.

Offerors may choose to provide a proposal for one, two, or all three functional categories; however, the functional category must be identified and meet all requirements for the specific functional category.

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.

21 In the Volume Two submittal for Functional Category 2, would it be helpful to attach additional information on our testing such as the complete study supporting the accuracy of the test including the specificity and sensitivity? Would the training brochure with illustrations on specimen collection be useful? Or would you prefer that only specified documents be submitted ?

Only submit documents that are required in RFP Section 11: Instructions to Offerors. Additional documents that are beyond what is requested will not be evaluated. When completing Attachment A, please do not include external links to websites or videos in your responses to the Attachment A questions.

22 FC 1, Volume Two Proposal: In the pricing section, should sanitizing the area price be included or since testing will be in a government facility, sanitizing the area will be covered by government janitorial services?

If sanitizing is a part of your complete solution, include the pricing.

23 FC 1, Volume Two Proposal: Should tables and chairs for the testing area be added to pricing also or will they be supplied?

If tables and chairs are a part of your complete solution, include the pricing.

24 Is there availability of the essentials of the Q&A elements available? Certainly, one question is the level of services required or desired. While I am aware that this is an IDIQ contract, is there a minimum or expected volume?

A complete audio file of the industry day is available via the Amendment 3 attachments at beta.sam.gov.

Minimum and maximum volumes with more detail than what is in the RFP is not available.

25 I am reaching out today to see if there will be a recording of the Industry Day posted on your website? If so, when can I expect to see it posted?

A complete audio file of the industry day is available via the Amendment 3 attachments at beta.sam.gov.

26 This is being implement in numerous locations for thermal scanning. This is not a COVID test, but a first line of testing for ongoing re-openings and a longer term solution for an overall business continuity plan. Are you aware of any RFP’s that are associated with this technology?

To view upcoming DHS opportunities, offerors are encouraged to monitor beta.sam.gov and view our forecast of contract opportunities https://apfs.dhs.gov/.

27 I wanted to reach out to you and your team to explore if we might be able to collaborate with FEMA on data collection that would serve as input into our research effort.

This requirement is not participating in research efforts.

28 I do not see the instructions for the solicitation submission.

Are expected to upload the response on SAM.gov? We’re trying to register now. I also saw a note that there may be other opportunities to submit responses to this or similar solicitations for CoVID-19 testing – is that accurate?

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.

To view upcoming DHS opportunities, offerors are encouraged to monitor beta.sam.gov and view our forecast of contract opportunities https://apfs.dhs.gov/.

29 Just checking to see if I am still able to submit my tests. I do not have the ability to do the testing but I do have substantial access to test manufacturing suppliers.

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.

30 I was wondering if you could advise to how the tendering process works in the USA and if we as a global entity could bid directly etc.?

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.

31 Is it possible to extend the deadline? The current proposal due date/time is August 12, 2020 at 12:00 PM Eastern Time. Please continue to monitor the beta.sam.gov post which states the due date/time.

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.

32 Want to verify the response date of this solicitation - July 29 2020? Do you require identification of interested laboratories ahead of the due date?

The current proposal due date/time is August 12, 2020 at 12:00 PM Eastern Time. Advance notice of an intent to submit a proposal is not required.

33 Do we submit a different pdf for each of our testing systems?

Offerors shall submit a separate Attachment A for each functional category 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.

34 Related to the functional categories (1, 2, and 3), will DHS provide indemnification to the contractors for the work performed under these IDIQ task orders?

No.

35 Will DHS procure equipment for placement at the CLIA lab for testing under this contract?

No.

36 Is a Point-of-Care/CLIA waived diagnostic test (not just sample collection, but on-site testing) a requirement for Functional Category 1, or is shipping all samples back to a CLIA laboratory after on-site collection sufficient?

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.

For FC 1, please see RFP Section 11: Instructions to Offerors, Paragraph 3.2.2.1 for instructions.