Solicitation_16-00072__Questions-Clarifications-Responses.docx

Solicitation Technical & Business Questions – Request for Clarifications The government response can be found in the bolded text next to each question.

Form 1449

1. By signing the Form 1449, are we agreeing to all of the terms? If we have exceptions to the terms of the RFP, how should we address? By signing the SF1449 you are agreeing to the terms and conditions of the solicitation.

2. Can we sign Form 1449 and still indicate any deviations/exceptions within the PWS or RFP? Yes you may sign the SF1449, and state any exceptions addressed within your proposal.

RFP Document

1. Part I – The Schedule, paragraph 1, page 3: references Section A. Please confirm that Section A is SF 1449. Section A is the SF-1449.

2. Article C.1. Performance Work Statement, Section b., page 5: Does the use of the Privacy Act System of Records Number apply to anything that will be done under this agreement? The Privacy Act System of Records Number is stated for information purposes as a reference to the Information Security and Physical Access Requirements in Article C.2 (b)(1) of the solicitation.

3. Article C.2. Reporting Requirements, section b. Contractor-Employee Non-Disclosure Agreement(s), page6: When does this form need to be completed and does it only apply to on-site employees of Contractor? Does anything need to be done for the RFP response? Attachment 7, the Non-Disclosure Agreement does not need to be submitted with the proposal however the agreement will need to be signed by all on-site contractors of the successful awardee.

4. Section E. Inspection and Acceptance, Section d., page 8: This section indicates that the contract incorporates the following clause, but there does not appear to be a clause included. Please clarify if there is something missing. Section E. Inspection and Acceptance, Section d., Page 8, the following Clause was omitted by error and hereby added back to the solicitation, FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996)

5. Article I.3. Additional Contract Clauses, Section c., page 19: This indicates there are clauses attached and made part of this contract. Was this intentionally left blank? Article I.3. Additional Contract Clauses, Section C., Page 19 is hereby removed from the solicitation.

6. Article I.4. Additional FAR Contract Clauses Included in Full Text, Section a)1.a, page 20: If we complete SAM and keep it updated, do we need to do anything separately for FAPIIS? FAPIIS information can be posted through the System for Award Management (SAM) database.

7. Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Terms, page 21-23: Are these all applicable or only those that are marked with an “x”? Only the clauses marked by an X are applicable for this section.

8. Section 9 Solicitation Provisions Incorporated by Relevance, section a., page 34: Does the Facilities Capital Cost of Money FAR Clause apply to this contract? Facilities Capital Cost of Money, FAR Clause 52.215-16, (June 2003) was included by error and is hereby removed from the solicitation.

9. Section J – List of Attachments, page 27: clarification on which documents need to be submitted with the RFP. Should they all be in the packet, even if they don’t appear to require a response? Do attachments like #11 (wage Disclosure) & #14 (Privacy Act) need to be re-included in the packet or should they be accompanied by confirmatory language? The only attachments that need to be submitted with the package are:

1. Attachment 6, Section K-Representations, Certifications, and other Statements of Offers, And submit with business proposal.

2. Attachment 10, Subcontracting Plan

3. Attachment 12, Disclosure of Lobbying Activities shall be submitted with the business proposal. If the offeror is currently not engaged in any lobbying activity state not-applicable in boxes 10.a and b, and complete box 11.

10. Att 7 Nondisclosure – Who do we fill this out for? Is this for the techs provided as a part of the contract or also our client affiliated staff? See response to question 3.

11. Att 8 summary-related activities – do a) & b) refer to the work our company does that isn’t related to NIH’s Department of Lab Medicine contract? c) can you define the metric for “total proposed effort”. Is this tasks, job descriptions, or monetary value? Attachment 8 is hereby removed as a requirement for the solicitation.

12. Att 9 NIH2043 – As our work with NIH’s DLM doesn’t include a principle investigator & co-investigator on our end, how should this be filled out on the form? Attachment 9 is hereby removed as a requirement for the solicitation.

13. Att 12 disclosure of lobbying attachments – if we do not retain a lobbyist do we omit this form? See response to question 9(3).

14. Section L.2.a.2 of the RFP: 16-000072 file (p. 30) indicates that offerors are required to submit an electronic copy to the IDIQ Contracting Officer (presumably by email) as well as one original and three copies. The Proposal Submission section of the RFP: 16-000072 file (p. 33) indicates that offerors are required to submit an email version of their proposal as well as five hard copies. Attachment 1 indicates that offerors are required to submit an original and five copies of the technical proposal as well as an original and five copies of the business proposal. These specifications for submission are not consistent; please confirm what is required. The requirement has been changed for each offeror to submit one (1) cd rom for both the technical and business proposal. Five (5) hard copies of the business and technical proposals are still required. The email submission is no longer required.

15. Are the five sections listed on pages 38-39 of the RFP: 16-000072 file (Mentor-Protégé Program, HUBZone Small Business Concerns, Other Administrative Data, Subcontractors, Proposer’s Annual Financial Report) required to be a part of Volume 2, Section 3: Small Business Subcontracting Plan? The instruction to the business proposal is hereby changed to include an additional section, Volume 2: Section 3.1 Business Reporting. Please address the paragraphs 1-5 of SECTION L, Business Proposal Instructions, pages 38-39 in this section.

16. Please clarify NIH’s expectations regarding the Mentor-Protégé Program section on p. 38 of the RFP: 16-000072 file. The Department of Health & Human Services (HHS) website indicates that HHS is not currently accepting new applicants for this program. (http://www.hhs.gov/asfr/ogapa/osbdu/chapter-14-mentor-protege-program.html) . An offeror would only submit information with their subcontracting plan regarding this requirement if they are currently involved in the Mentor-Protégé Program.

17. Section 3.1 of the PWS states that the Contractor shall collect specimens located through the NIH campus. Is “collect specimens” is a requirement for the Contractor to pick up specimens for transportation to a testing laboratory, as opposed to specimen collection services (ex. phlebotomy)? If specimen collection services are required, please provide specific details around NIH’s needs. The contractor shall only pickup samples from ONE location: National Institutes of Health, Department of Laboratory Medicine, 10 Center Drive Building 10, Floor 2, Bethesda, MD 20892.

18. Section 3.3.1 of the PWS states that the Contractor shall provide on-site liaison customer service Monday through Friday. Is this support in addition to the on-site personnel described in Section 2.7 of the PWS? On-site liaison customer service Monday through Friday shall be provided by the on-site personnel. The liaison customer service is not in addition to the on-site personnel, it is one of the duties performed by the on-site personnel.

19. Is NIH willing to negotiate changes to the requirements set forth in Section 7.0 of the PWS? This bidder performs a SOC 2, type 2 assessment covering the Security and Availability principals on our key environments; would NIH be willing to accept this assessment in lieu of the requirement to perform a NIST assessment annually? NIH is not able to negotiate on the security language terms set forth in Section 7.0 of the PWS due to federal, OMB and HHS requirements to safeguard data that the NIH has been entrusted to secure from our patients/volunteers. The SOC 2, type 2 can be used to supplement the NIST requirement, but not in lieu of the NIST requirements for the System Security Plan (SSP). Many of the requirements for SOC 2, Type 2 are the same or comparable to the NIST requirements. See reference, https://www.aicpa.org/InterestAreas/FRC/AssuranceAdvisoryServices/DownloadableDocuments/OtherMapping/Trust_Services_Map_to_NIST_800-53_R4.xlsx

20. Section 8.0 of the PWS instructs offerors to submit copies of certification and inspection certificates by their accrediting agencies to http://www.in.gov/isdh/20129.htm; this is a link to the Indiana State Department of Health website. Please clarify this requirement – why are offerors required to submit certifications to the Indiana State Department of Health and specifically how does NIH expect the offerors to do so? Section 8.0, page 33 of the PWS is hereby modified to state: The Contractor and subcontractor laboratories shall be certified and up-to-date in accordance with the Clinical Laboratory Improvement Act (CLIA) of 1968 and 1988, to perform laboratory testing services under this contract. Offerors shall submit only copies of the College of American Pathologists (CAP) and CLIA certificates of accreditation as part of the technical package in response to this solicitation.

21. Several of the attachments (Attachments 1, 3, 5, 11, 13, and 14) appear to be provided for informational purposes only. Do these attachments need to be returned with offerors’ proposals? See response to question 9.

22. Attachment 7 is an NDA for contractors/subcontractors. Please confirm this document shall be required from the successful bidder (i.e. the Contractor), as opposed to each offeror. See response to question 3.

23. Attachment 8 requires that offerors identify a project director and principal investigator. Please clarify this requirement as it relates to this RFP, which is for clinical testing and not a research study. See response to question 11.

24. Attachment 9 requires that offerors identify the name/title of the principal investigator as well as the name(s)/title(s) of co-investigator(s). Please clarify this requirement as it relates to this RFP, which is for clinical testing and not a research study. See the response to question 12.

25. Does Attachment 12 need to be completed and submitted with all proposals, or will that Attachment only be required from the successful offeror (i.e. the Contractor)? See response to question 9(3).

26. Please provide a list of all NIH locations that will require a specimen pickup and each location’s address.

Please see response to question 17.

27. Please confirm that supporting documents provided by offerors as attachments (ex. CLIA certificate, transition plan) are not included in the page limitations identified in RFP Amendment 02. The technical proposal, Sections 1-3 page limit has been extended from 20 to 30 pages which shall include the CLIA and CAP certificate, as well as the transition plan.

28. Does the NIH email system have file size limitations that offerors need to be aware of at the time of bid submission? See response to question 14, the email submission is no longer required.

29. Should each offeror add their laboratory’s Test Code, Test Description, turnaround time (TAT), and methodology to the Att 4 – Specimen Test Schedule file? If so, should the information be added in Columns Q, R, S, and T? Offerors should not provide their test codes, test descriptions, turnaround times and methodologies to Attachment 4, Specimen Test Schedule. As stated in the Mandatory Qualifications Criteria, SECTION M on page 41 of the Solicitation, the testing methodologies and turnaround times cannot be modified or substituted. Price Information should only be listed in columns G-P.

30. Are offerors expected to provide information in Column F of the Att 4 – Specimen Test Schedule file? Please clarify NIH’s expectations. Offerors are not expected to supply information in column F of the Specimen Test Schedule. This column only indicates that all specimen pickup will occur Monday through Friday after 3:00pm.

31. Please provide components for the panels listed below.

VOLUME

Lamb's Quarters

Mugwort

Western Ragweed

Scale

Aspergillus fumigatus

Candida albicans

Cladosporium herbarum

Helminthosporium halodes

Penicillum notatum

Dermatophaggoides farinae

Dermatophaggoides pteronyssinus

Hollister-Stier

Bahia

Johnson

June/Kentucky Blue

Rye

Timothy

Codfish

Salmon

Shrimp

Tuna

Brazilnut

Coconut

Hazelnut

IgE Antibodies, Multi-Allergen

Peanut

Coconut

Peanut

Pecan-Food

Sesame Seed

Antinuclear Antibody

Mitochondrial Antibody

Chain of Custody

Creatinine

Nitrite

Oxidants

Specific Gravity

Antibody 23 Sertypes, serum

Cadmium

Lead

Mercury