Questions and answers.docx

1. Is this requirement a new solicitation or a re-competition? If it is a re-competition, please provide the incumbent contractor's name, contract number, and current contract value or annual spending, if available.

As stated in the SAM posting, all questions regarding the previous contract shall be directed to the appropriate FOIA office.

2. Can the Government provide historical workload, annual expenditures, task order values, and incumbent pricing information, to the extent releasable, to assist offerors in developing competitive pricing?

As stated in the SAM posting, all questions regarding the previous contract shall be directed to the appropriate FOIA office.

3. Any concerns or issues in the current contract?

As stated in the SAM posting, all questions regarding the previous contract shall be directed to the appropriate FOIA office.

4. Is there a page limitation for the Key Personnel Curriculum Vitae (CVs)?

No

5. If an offeror is not proposing any subcontractors, is the VAAR 852.219-77, Notice of Limitations on Subcontracting – Certificate of Compliance, still required to be completed and submitted?

Please note the incorrect clause was referenced on page 33 of Attachment #2 Under B, 4). The updated attachment has been provided.

Yes, IAW with that same section: “To be eligible for evaluation and consideration for award, offerors must return the entire Limitations on Subcontracting Certificate of Compliance clause containing a fully completed certification at the time offers are due or the offer will be rejected and not forwarded for evaluation. In addition to completing the offeror ‘fill-in’ requirements for this clause, offerors must insert the offeror’s name in the brackets containing the following verbiage “[Insert Name of Offeror]” to have a fully completed certification.”

6. We observed that several columns in the pricing workbook are hidden. Is this intentional? If so, please identify the required columns that offerors are expected to complete and submit as part of the pricing proposal.

Hidden columns are system generated and not relevant to the quote (you can confirm by unhiding them).

The only column that should require input is “O.” Column “DA” should automatically populate.

The CO did find an error on the spreadsheet. The revised version is attached.

7. Offers can submit relevant commercial Past Performance in similar scope, size and complexity to this solicitation? More specifically, the question relates to Attachment 2, Clauses_Provision_Submit Document, Section VI, Past Performance (Page 35), which references past performance for federally funded research.

If an organization has not yet had the opportunity to perform CRQA related services directly under Federal funded contracts or for Federal agencies. The team has supported several clinical research sites and sponsor organizations by providing contract professionals who have performed Clinical Research Quality Assurance (CRQA) activities under commercial engagements.

Given this experience, could you please clarify whether offers may submit relevant commercial past performance of similar scope, size, and complexity in lieu of Federal past performance to satisfy the requirements of this solicitation?

Relevant is defined in the solicitation as being for similar services.

Therefore, similar services will be considered.

8. Can you specify any specific background or drug screening applicable for this solicitation?

Full background investigation as stated in the PWS Section 8.7.

8.7 Background Investigation: The level of background investigation commensurate with the required level of access is NATIONAL AGENCY CHECK WITH WRITTEN INQUIRIES (NACI) (cost is approximately $230).

Drug Screening – no

9. Can the government clearly specify what are the required columns need to be submitted as part of Attachment 3 Pricing?

Please see the response to question #6.

10. For the pricing proposal, should offerors submit Attachment 3 as the pricing submission, or is any additional pricing format or documentation required?

IAW the Quote submission instructions F, 1):

“Completed Excel spreadsheet (Attachment 3 CLINS_Pricing Sheet).”

11. Attachment 2 G, Section VI Past Performance, Pg.35 states “Provide at least three (3) recent and relevant references for listed experience of delivering GCP monitoring or auditing services for federally funded research, AND “Do not provide past performance narrative from the references, the Government will contact all references directly. Only the first three references will be accepted. References beyond three will not be considered.”

Please clarify the # of past performance references that should be submitted.

The requirement is for at least three past performance references. Anything over three will not be accepted. Attachment #2 was revised for clarity.

12. Which therapeutic area(s) are included in the scope of this Statement of Work (e.g., Oncology, Cardiology, Immunology, Rare Disease, etc.)? Reference Attachment #1 (PWS), §2.0 Background & §4.0 General Scope, Pg.1–2 VACSP conducts a diverse array therapeutic areas such as Alzheimer to Urinary Tract infection but no limited to.

13. How many protocols are expected to be supported under this contract at any given time? Reference Attachment #1 (PWS), §2.1 Background, Pg.1 SMART is currently monitoring over 15 active protocols, with the exact number potentially varying.

This is an Indefinite Delivery Indefinite Quantity Contract IAW RFO 16.504. Quantities are not known at this time. The Government estimates but can never guarantee anything except the minimum award guarantee.

14. What is the anticipated split between visits requiring travel and visits conducted remotely? Reference Attachment #1 (PWS), §5.0 Specific Requirements & §6.0 Travel, Pg.2 & Pg.8.

This is estimated 3-1 off site/onsite per year. That is variable and highly dependent on the monitoring plan, the design of the trial, or is it FDA regulated.

This is an Indefinite Delivery Indefinite Quantity Contract IAW RFO 16.504. Quantities are not known at this time. The Government estimates but can never guarantee anything except the minimum award guarantee.

15. PWS Section 5.1.2 states that visits may range from one to four days in length. Can the Government provide the assumed distribution of 1-day, 2-day, 3-day, and 4-day visits? Reference Attachment #1 (PWS), §5.1.2, Pg.3

However, this is subject to change based on complexity of the study, the number of findings, how many cases that need to be reviewed, etc.

This is an Indefinite Delivery Indefinite Quantity Contract IAW RFO 16.504. Quantities are not known at this time. The Government estimates but can never guarantee anything except the minimum award guarantee.

16. PWS Section 7.3 establishes minimum experience requirements for CRQA personnel. Can the Government confirm whether this requirement applies to each individual assigned, or whether a blended team may be proposed with at least one resource meeting the minimum threshold? Reference Attachment #1 (PWS), §7.3 Contractor Qualifications, Pg.9–10.

Please see PWS 7.1

17. Will Meals & Incidental Expenses (M&IE) be reimbursed at the per diem rate, or will actual expenses be reimbursed up to the allowable per diem cap? Attachment #1 (PWS), §6.2.1.1 Travel, Pg.8.

PWS 6.2.1 was updated to clarify.

18. Attachment 2, page 33, item B.4 references VAAR 852.219-77, Notice of Limitations on Subcontracting – Certificate of Compliance, which is not available at https://www.va.gov/oal/library/vaar/vaar852.asp. Can the Government confirm whether completing and signing VAAR 852.219-75, VA Notice of Limitations on Subcontracting – Certificate of Compliance for Services and Construction (Jan 2023) (Deviation), satisfies this requirement?

This was a typo, please reference question #5 above. The full text of the clause is listed on page 27 of Attachment #2.

19. Section VI requires three recent and relevant references for GCP monitoring/auditing services for federally funded research. Will a reference be considered eligible if the underlying contract was held by a subcontractor, rather than the offeror as prime, performing that work under another company's prime contract? Reference Attachment #2, G, Section VI Past Performance, Pg.35.

Yes, from Attachment #2 please ensure you note if the work was performed by the Prime or the Sub. For example, The Sub was the Prime on the reference, the Prime was the Sub on the reference, the Prime was the Prime on the Reference, the Sub was the Sub on the reference.

20. PWS Section 8.12 references a list of VA and associated sites (within 75 miles) applicable to ordering periods 1 and 2, but the table was not populated in the version of the PWS provided with the solicitation. Can the Government furnish the current site list so offerors can accurately estimate travel requirements for pricing purposes? Reference Attachment #1 (PWS), §8.12 Multi-Sites, Pg.11–12.

The document was checked; the sites are listed in the PWS on page 19-20.

Please note, the offerors are not expected to submit any quote for the travel CLIN. This will be a government established amount. If quotes are submitted with the travel CLINS populated with a price, the price will not be considered for evaluation or award. See Attachment #2, Quote Submission Instructions, F, 1), d).

21. CLINs 0003, 1003, and 2003 are designated as Government-determined amounts not completed by the offeror. Can the Contracting Officer confirm the rate basis (e.g., current GSA per diem/travel tables) used to establish these amounts, so offerors can properly evaluate the overall price structure? Reference Attachment #3 (CLINs), Items 0003/1003/2003; Attachment 2, Section V.F.1)d), Pg.35.

See the response to question #20. The Government will provide a ceiling for this CLIN at time of award. Individual task orders will also provide a ceiling for the Travel CLIN when ordered. Payment for travel will be IAW PWS 6.0.

22. Given that monitoring visits occur nationwide (approximately 300–400 investigative sites) while SMART is based in Albuquerque, NM, is there any preference, requirement, or evaluation consideration tied to a contractor's or CRQA's geographic proximity to New Mexico? Reference Attachment #1 (PWS), §2.2 & §8.9 Place of Performance, Pg.1 & Pg.11; Attachment 2, E.1 Evaluation, Pg.36 The PWS lists no qualification requirement for geographic proximity. Evaluation of technical quotes is outlined in Attachment 2.

23. As this is a single-award IDIQ, can the Government provide any additional insight into anticipated order frequency or typical order size within the stated $20,000 minimum and $2,000,000 maximum, to assist offerors in developing an appropriately scaled staffing plan? Reference Attachment #2, Section V.F.2), Pg.35; C.4 52.216-22 Indefinite Quantity, Pg.7 The estimated amount of visits per Fiscal Year is 10 – 150. These visits can be one day on site or one day off sites, two day on site or two day off site, three day on site or three day off site; four day on site or four day off site visits depending on complexity of study, monitoring plan, etc.

This is an Indefinite Delivery Indefinite Quantity Contract IAW RFO 16.504-2. Quantities are not known at this time.

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