Amendment 5 - SF30 and Q_A.pdf

(x)

70RDAD20R00000012

x x

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.

x

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

07/21/20200005

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 22, 2020 at 12:00 PM Eastern Time

(ET) to July 29, 2020 at 12:00 PM ET.

b. To provide Government responses to vendor questions, including questions from the industry day held July 9, 2020. Multiple questions are still pending Government review and responses will be provided via a forthcoming amendment to the solicitation.

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 5

Questions and Answers

Q# Question Answer 1 On page 7, under 4.2 Functional Category 2 – Molecular

Diagnostic Test Kits and Testing Services, bullet point #4 has a list of materials necessary from sample collection to result output. Most diagnostic manufacturers do not make kits that contain all of these items. Is DHS interested in specific components from this list or does the respondent need to have all components pre-kitted in order for DHS to be interested in their proposal? Please clarify.

Yes, the vendor needs to provide all the necessary components to collect samples and successfully transport them to the laboratory where the test is run.

It means the nasal or oral swabs, the transport media, the reagents needed to run the test, etc.

2 Is the DHS interested in companies that can provide the molecular diagnostic test kits, but that do not perform the testing services aspect of the RFP? It is a very quick turnaround for a contractor to identify a company providing these services and enter into a teaming agreement. Is the DHS interested in a proposal where a contractor supplies the testing kits to DHS and DHS contracts with a separate entity to perform?

No. Under Functional Categories 2 and 3, the vendor needs to also provide testing and reporting services.

DHS requires a complete solution for a particular Functional Category and will not contract separately if only one element of the statement of work is proposed. Please review the solicitation instruction and evaluation sections carefully. It is the contractor’s responsibility to identify and develop a teaming agreement or other business relationship to respond to all of the requirements stated in this solicitation. Vendors may choose to propose on one, some or all Functional Categories.

3 On page 5, under section 3 of the RFP it states “testing shall occur at point-of-care settings at government designated locations”. Does this mean that diagnostic tests offered to DHS will need to be CLIA Waived or will DHS be able to use CLIA Moderate tests?

Samples are to be obtained in a point-of-care fashion (meaning in the workplace). For PCR tests, the requirement (as stated in Functional Category 2) is that the prospective vendor provide documentation of an established relationship with a CLIA certified lab to perform high complexity tests at high volume. The same exists for Functional Category 3 (Antigen testing).

4 On page 7, under 4.2 Functional Category 2 – Molecular Diagnostic Test Kits and Testing Services, bullet point #7

The government anticipates changing the requirement from business days to calendar days in an upcoming states – “Return test results in no more than three (3) business days from the time a sample is received for lab processing”. Please clarify if DHS is interested in products or services as this is contrary to Pg. 6 – Section 4.0 where it states, “Functional Categories 2-4, no contractor staffing to administer the test is required”.

solicitation amendment. The metric is different in Section 4.1 for Functional Category 1 because the expectation is that the managed service provider is doing the collection. Under Functional Category 2 and 3 the requirement is that the vendor return the test results in no more than three (3) business days from the time the sample in received for lab processing. In the case of Functional Categories 2 and 3 the expectation is that the sample is being sent to a lab.

These processing times apply at the IDIQ level. More stringent processing times and service level agreements (SLAs) may be applied at the order level based on component requirements.

5 Does section 4.5 on page 9 or 4.6 on page 10 apply to tests kits that are supplied to DHS under sections 4.2-4.4? If these do apply to 4.2-4.4, how does DHS envision that implementation with Pg. 6 – Section 4.0 stating, “Functional Categories 2-4, no contractor staffing to administer the test is required”?

Yes, Section 4.5 does apply to Functional Categories 2 and 3 (Functional Category 4 has been removed from the SOW). The verbiage in Section 4.0 relates to having the vendor for Functional Categories 2 and 3 NOT having to provide staff to obtain the test samples from DHS workers.

6 As the government is requiring Computing Integration capability, is the government going to pay the integration cost to create this capability?

No. It is the expectation of the Government that offerors will have existing integration points that will provide for the electronic exchange of test results.

7 As a private entity is connecting to government systems what are the Government IT security requirements that have to be met?

Integration with Government systems is the responsibility of the Government; however, the offeror must provide secure integration mechanisms with native capabilities of their proposed solution.

Systems requiring encryption shall use products that employ FIPS 197 Advanced Encryption Standard (AES) algorithms with at least 256-bit encryption and have been validated under FIPS 140-2.

8 Please provide an example of the data exchange technique. An example of the data exchange technique is Secure File Transfer Protocol with certificate-based authentication.

9 The proposal instruction states that offerors shall complete and submit Attachment A for each functional category proposed. Please confirm that if an offeror is proposing multiple categories that the "Offeror Information Table" response is required for each categories response as the required information would be similar for all 3 functional categories.

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.

10 The proposal instruction states that offerors shall complete and submit Attachment A for each functional category proposed. Given that the Attachment A response is limited to 12 pages, confirm that the questions 1-20 is required separately for each proposed category. If yes, would USG consider adjusting the page limit to 20 pages?

The page limit remains unchanged. 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.

11 The RFP states, “The contractor shall provide COVID-19 diagnostic testing and associated services as a managed service, to include on-site screening, testing, and results tracking, on a routine basis at DHS designated locations.”

Please provide the anticipated number of DHS locations that will need Managed Testing Services simultaneously?

The resulting award of this RFP is an IDIQ contract.

Multiple IDIQ contracts are anticipated to be awarded; therefore, it is not expected that a single vendor will be providing all of DHS' service requirements. An accurate estimate of specific location requirements cannot be provided at this time.

At the IDIQ level, more general requirements are provided to allow for ordering flexibility. More specific information on the locations will be provided in task order requests for proposal.

12 Please clarify if the “500 individuals per day” equates to 500 tests per day, per site (CONUS/OCONUS)? Is this amount individuals being tested per day?

The scenario provided does not represent an actual requirement, it is only provided in order for price to be evaluated. Offerors shall assume it is a single site.

Specific locations will be identified at the IDIQ order level, in which each order is competed amongst the IDIQ contract holders.

13 Does DHS plan to issue any TOs that don't include testing services but instead the infrastructure and data management to support testing?

No. The tests and the computing/communications components to manage the process, and to share the results with the Government are expected to be part of the offeror’s comprehensive solution. The Government will be retrieving the test results using their own IT infrastructure via a secure transport (See question #7).

14 Will the solicitation remain open, so that additional proposals may be submitted after the initial deadline?

The solicitation will close at the time and date specified, so please ensure proposals are submitted on time. After it closes, the solicitation will remain posted on beta.sam but will not be open. It will be amended to reopen the solicitation period with a new due date and time. Proposals will not be accepted until the solicitation is reopened.

15 Can an offeror include one or more additional tests in their ID/IQ bid whose final EUA has yet not been isssued at the time of ID/IQ bid submission but is expected to be issued before contract award?

No, the offeror shall only include tests in their proposal that have received an EUA from the FDA.

16 Given the rapid innovations in testing technology, is DHS open to submission of tests with improved specificity and sensitivity, especially those who are pending FDA authorization?

No, the offeror shall only include tests in their proposal that have received an EUA from the FDA.

17 Can an offeror include one or more additional tests in their ID/IQ bid whose final EUA has yet not been issued at the time of ID/IQ bid submission but is expected to be issued before Task Order award?

No, the offeror shall only include tests in their proposal that have received an EUA from the FDA.

Please note that Paragraph 3.1.1 of RFP Section 11:

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

18 Can we submit a testing solution that includes both quantitative and specific virus and antibody testing (perhaps as a separate/hybrid Functional category) that produces a comprehensive report and resiliency rating for each test subject?

At this time, DHS is not accepting proposals for antibody testing (whether it be qualitative or quantitative).

19 Is the department looking for a “screening” testing capacity to test all employees/visitors, regardless of whether individuals are symptomatic or asymptomatic?

This is a requirement for COVID-19 testing solutions.

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

20 What would be the smallest and largest groups to be tested at potential sites?

The size of groups to be tested would be defined at the task order level.

21 If an offeror does not get an award following the July 15th closing date, can the offeror reapply under the same functional categories (FC) that were included in its original offer?

Yes. Once the solicitation is reopened, an offeror may resubmit an offer under the same FC. Being an unsuccessful offeror for a prior competition does not exclude participation in a future one. Also see Question #14.

22 If an offeror does not get an award following the July 15th closing date, can the offeror reapply under a different FC?

Yes, also see Question #14.

23 Are any portions of the IDIQ, upon specific contracting, going to be a Service Disabled Veteran Owned Small Business set aside?

The IDIQ competition is unrestricted. Please also see Section 6.10 of the solicitation which states that Task order set-asides will be discretionary when the conditions in FAR 19.502-2 [the rule of two] and the specific program eligibility requirements are met at the time of order set-aside.

24 Do the responses to FAR 52, 212-1, 52.212-4 FAR 52.212- 3 AND 52 212-5 also need to be included under the response?

Yes, please include these with the pricing information.

25 Should responses to FC1 be limited to the managed services themselves since each test scenario needs to also be individually responded to?

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

26 We see the that "All-in per test" pricing are encouraged but also see that 3.2.2.1 1 for example implies that a break out of all labor categories and labor rates are

Per the instructions at Section 11, Paragraph 3.2.2.1 the following are required, not just an all in per test price.

required Could you clarify if ONLY providing an "all in per test" pricing is sufficient?

a. All labor categories required to complete the scenario;

b. A description of the qualifications of each labor category proposed;

c. A labor rate for each labor category proposed;

d. The number of hours required of each labor category proposed;

e. A description of all materials required to complete the scenario;

f. The total price for all materials required to complete the scenario; and

g. The total price of all labor and materials required to complete the scenario (total price for the scenario).

27 If an offeror gets an award this time under one FC, can the offeror apply later under a different FC and, if successful, obtain a modification to the contract to add the new FC?

Yes. Once the solicitation is reopened, a successful offeror may resubmit an offer under a different FC.

Also see Question #14.

28 Section 6.3 of the RFP states that “at the Contracting Officer's discretion, this solicitation will remain open for approximately one year with periodic closing dates ” However, future closing dates are not specified.

After the solicitation closes, it will remain posted on beta.sam but will not be open. The solicitation will be amended to reopen the solicitation period with a new due date and time. It isn’t anticipated that future dates will be posted collectively so interested offerors are encouraged to monitor beta.sam. Also see Question #14.

29 Are offerors only allowed to bid on Task Orders under the Functional Category that they propose to at the ID/IQ level?

Yes. When an IDIQ is awarded it will be for a particular FC or FCs. The awardee will only be able to participate in task order competitions for the FCs included in its award. Please see Section 6.8.1.1 for task order ordering procedures.

30 Are awardees allowed to discount per-test prices or add volume discounts at the Task Order level?

Yes, discounts are encouraged both at the IDIQ and Task Order level.

31 If an offeror is reselling test kits from an authorized reseller, rather than directly from the OEM, please confirm that a letter of support to the offeror from the OEM, on OEM letterhead, establishing the products being sold and the authorized reseller they are being sold through, in combination with documentation of test kit purchases from the authorized reseller, meets the requirements of section

3.1 2 of the RFP.

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

Please be mindful that test kits are only a part of the solution being sought. For all functional categories DHS requires a comprehensive solution: test kits, the necessary components (transport media, the reagents needed to run the test, etc.), transport to the lab, lab processing, results and reporting.

32 Please clarify what is meant by the IDIQ will remain open beyond the currently published due date.

The solicitation will close at the time and date specified, so please ensure proposals are submitted on time. After it closes, the solicitation will remain posted on beta.sam but will not be open. It will be amended to reopen the solicitation period with a new due date and time. Proposals will not be accepted until the solicitation is reopened.

33 Are the labor rates proposed in the IDIQ considered ceiling rates for CONUS and OCONUS locations?

The IDIQ labor rates will be ceiling rates. If you have separate CONUS and OCONUS rates, please provide them in the Schedule B pricing table.

34 If the amendment will be issued on/about 7/10/20, will the bid due date be extended?

The date has been extended to July 29, 2020 per Amendment 5.

35 Capability Questionnaire, Question 20 states "Does your test kit have FDA proof of test performance data submission and validation? If so, please provide -- The 12 page limit makes it very hard to provide the test performance data in full. Would the DHS prefer that only a summary of the test performance data be submitted or that FULL performance data added but in addition to the 12 page limit, or a web link allowed for this purpose?

The FDA proof of test performance data may be included as a separate attachment that is not included in the page count. Please see revised section 11.

36 Would DHS consider extending the due date to Friday July 17, 2020 ?

The date has been extended to July 29, 2020 per Amendment 5.

37 Will DHS be extending the due date? The date has been extended to July 29, 2020 per Amendment 5.

38 The RFP states, “Return test results in no more than three

(3) business days from the time a sample is obtained from the individual.” Would the Government consider changing the language to 'Return test results to DHS in no more than three (3) business days from the time the laboratory finishes processing the test"?

No. The government is changing the requirement from business days to calendar days in this solicitation amendment.

39 How many vendors are anticipated to be selected under the multiple award IDIQ?

The government has not set a number.

40 With the view of price calculation and the contract allocation can the price be amended if the volume increased or drops?

The IDIQ rates are ceiling rates. Successful IDIQ awardees will also have the opportunity to set task order prices based on the specific volumes and requirements stated in those orders.

41 We are teaming. Do all vendors need to be in SAM at time of response on the 15th?

All vendors will need to be registered in SAM prior to award. Registering in SAM as soon as possible is encouraged.

42 Is DHS planning to open up the RFP at a future date and if so, when?

Yes. After the solicitation closes, it will remain posted on beta.sam but will not be open. The solicitation will be amended to reopen the solicitation period with a new due date and time. Proposals will not be accepted until the solicitation is reopened.

43 Will you need vendor to submit/Bill healthcare Understanding tricare, etc.

The IDIQs do not allow for cost reimbursement. DHS will not bill for testing through health insurance companies, therefore, the vendor will not be expected to submit claims to health insurance companies.

Please see Schedule B, pricing table and Section 11, Paragraph 3.2.2 of the solicitation for pricing instructions.

44 Does DHS have a pipeline of opportunities that you can share from DHS agencies they expect to place on the vehicle in the near term?

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

45 Is DHS interested in contact-free screening solutions, and if so, is there a place for those type of solutions under this opportunity, or would there be future DHS opportunities

The purpose of this procurement is to obtain COVID- 19 testing solutions. It does not include screening. In general, the government posts its solicitations on https://apfs.dhs.gov/ https://apfs.dhs.gov/ that may cover COVID screening solutions - as opposed to testing solutions?

beta.sam or GSA eBUY. Please also see the response to question 49.

46 Does DHS have an estimated amount of vendors they plan to award to?

The government has not set a number.

47 Can the Government clarify that variable costs such as including test kits, test diagnostic (lab) services and personal protective equipment (PPE) will be paid on a time and materials basis?

Please see Schedule B, pricing table and Section 11, Paragraph 3.2.2 of the solicitation for pricing instructions.

48 How will DHS enforce requirements for testing facility subcontractors? Will subcontractors need to be identified in proposal?

Subcontractors need to be identified in the proposal.

49 Section 6 3 Open Solicitation states "this solicitation will remain open for one year with periodic closing dates."

Would DHS consider accepting proposals after the due date on a rolling basis?

After the solicitation closes, it will remain posted on beta.sam but will not be open. The solicitation will be amended to reopen the solicitation period with a new due date and time. Proposals will not be accepted until the solicitation is reopened.

50 Will DHS provide reimbursement for the cost per test or is there an expectation that a CPT code will be charged for reimbursement?

The IDIQs do not allow for cost reimbursement.

Please see Schedule B, pricing table and Section 11, Paragraph 3.2.2 of the solicitation for pricing instructions.

51 Is the requirement for results to be returned in 3 days from the time the sample is taken, or from the time it arrives at the lab for processing?

For Functional Category 1 (Section 4.1), the requirement is for the results to be returned in 3 calendar days from the time the sample is taken. For Functional Categories 2 & 3, the results are to be returned in 3 calendar days from the time the sample arrives in the lab for processing.

52 Can you please confirm if FDA cert is needed for all three categories?

Yes, an FDA EUA or FDA authorization is needed for all Functional Categories. Please see Section 4.0.

53 Please explain the difference between FC1 and FC2/FC3 if all FCs need to provide a complete solution (testing, kits, transport, reporting, etc.

The key difference is the staffing who collects the sample. 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.

54 Please designate which questions in Attachment A apply to FC1, FC2, and FC3, respectively.

For attachment A, all offerors for all FCs answer questions 1-20. Only offerors proposing FC 1 answer the additional 3 questions on page 4.

55 What hours are required for on-site test collection? The hours for collection will be specified at the task order level.

56 For Function Areas 2 and 3, is the performer required to provide the sample collection, transport, and shipping materials or only the laboratory based testing kit materials?

Functional Categories 2 & 3 do not require the offeror to provide sample collection but do 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.

57 The RFP states that DHS intends to keep the solicitation open for one year to provide offerors with the opportunity to provide a proposal in the future. If a company is not ready to submit a complete proposal by July 15th, @ 12:00 PM, can you please advise when will be the next opportunity to submit a proposal?

A specific date is not available at this time, but it is expected to be after award of the initial IDIQs.

58 Could you please give an example and distinguish Managed Services from Testing Services? Do Managed Services only include additional medical professionals and staff at the point of care?

A Functional Category (FC) 1 offeror must provide the medical personnel to collect the samples from the workforce or detainees, in addition to complete testing solution for either molecular testing or antigen testing.

See also the response to question 59.

59 Where can we get information on vendors looking to partner up with other vendors such as a test kit manufacturer looking for testing service providers or lab service providers?

General information on doing business with DHS can be found at https://www.dhs.gov/do-business-dhs.

This site provides resources to reach our small business and industry liaison team.

60 Would a proposal be acceptable for Functional Areas 2 and 3 from a CLIA certified laboratory if letters of support were obtained from a Test Kit manufacturer with a commitment to provide required test kits?

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

61 Can DHS clarify the answer to Question 16 in Amendment 2? Does the answer relate to the IDIQ contract level or Task Order Level following an IDIQ award?

The answer to Question 16 is as follows:

DHS intends to keep the solicitation open for one year to provide offerors with the opportunity to provide a proposal in the future. Also, since the award resulting from this solicitation is an IDIQ contract, immediate standup/performance requirements are specified at the order level.

The above answer relates to the IDIQ. Task order solicitations will be issued individually by the various components after the IDIQs are awarded.

https://www.dhs.gov/do-business-dhs https://www.dhs.gov/do-business-dhs