QA(continued).docx

13 April 2015

FA3047-15-R-0006

Questions & Answers (continued)

1. Question: What is the total value of the current contract including option years?

Answer: The current contract total value is $530,492.31.

2. Question: Is the current contract a base + 4?

Answer: The current contract is not a base + 4.

3. Question: How many FTE's (Full Time Equivalents) are associated with this current contract?

Answer: There are 6 FTE’s associated with the current contract.

4. Question: Paragraph 2.4.4 appears to indicate that we should price in a 6-month extension into our response. Is that a correct interpretation or should our response only price the base + 4 option years?

Answer: Only price the base + 4 options periods. The 6-month extension pricing will be the same as the last option period exercised should the government chose to exercise a portion or all of the extension period.

5. Question: Regarding page limitations for the technical volume, is the Table of Contents excluded from the page count?

Answer: See Addendum 52.212-1; paragraph 1.2 Page Limitation, 3rd sentence. “This page limitation does not include the cover page and index of the volumes.

6. Question: Please confirm that there is no page limitation for Volume I, Price Proposal.

Answer: Confirm there is no page limitation for Volume 1, Price Proposal.

7. Question: Please confirm that the deadline for questions is Friday, 10 April @ 1500 CDT and not Wednesday, 10 April @ 1500 CDT as stated.

Answer: Confirm the deadline for questions is Friday, 10 Apr 15 at 1500 CDT.

8. Question: The PWS calls out a requirement for two (2) Biomedical Laboratory Technicians in paragraph 1.4.1 and CLINs 0004, 1004, 2004, 3004, & 4004. However, on page 171, Technical Factor 2.4.2 (paragraph 3(ii)) discusses the evaluation of compensation plans for a Laboratory Manager, but it is not called out in the in the PWS or the CLINs. In addition, paragraph 1.3.1.12 (page 35) states "In coordination with Government Laboratory Manager...". Would you please clarify if a Laboratory Manager is a requirement for the CLINs listed above (if so, does the government require 1 FTE?), or is the government requiring Biomedical Laboratory Technicians only (2 FTE)?

Answer: No Laboratory Manager is required. See SF30 Addendum.

9. Question: In regards to SF1449 Continuation Sheet Supplies/Services Estimated Quantity; CLIN estimated quantity of hours is 1936 and 3872. Can the government clarify the need for 1936 hours per position? Does this amount include overtime?

Answer: The government will require 1936 hour per position (See PWS paragraph 1.5.2) as this is a leap year. Overtime is not included.

10. Question: In regards to RFP Page 36: 1.3.2 Clinical Research Duties; Can the government clarify which duties are perfromed by the CRC Licensed Vocational Nurse?

Answer: Duties are to be performed in accordance with qualifications. LVNs not required to perform IBR protocol documentation of paragraph 1.3.2.7 based on qualifications stated in paragraph 1.4.3. See paragraph 1.4.2.4 for CRC RN experience and paragraphs under 1.3.2. for duties.

11. Question: In regards to RFP Page 36: 1.3.2 Clinical Research Duties; Can the government clarify if there are any duties that are performed by CRC Registered Nurse that cannot be performed by the CRC Licensed Vocational Nurse?

Answer: See paragraph 1.4.2.4 & 1.3.2.7 qualifications.

12. Question: In regards to RFP Page 36: 1.3.2.1 “If the potential study participant consents, the Contractor shall enroll subject, obtain written consent, and collect appropriate samples at established collection sites.”; Are “established collection sites” located onsite or will offsite local travel be required?

Answer: Established collection sites are located onsite.

13. Question: In regards to RFP Page 41: 1.4.2. Clinical Research Coordinator (CRC) – Registered Nurse “1.4.2.1. Shall have, at a minimum, a Bachelor’s Degree in Nursing and five (5) years clinical experience.” If there are no specific requirements that require a RN position, can the government clarify if the CRC must be a licensed Registered Nurse?

Answer: See paragraph 1.4.2.4 & 1.3.2.7.

14. Question: In regards to RFP Page 41: 1.4.2. Clinical Research Coordinator (CRC) – Registered Nurse “1.4.2.1. Shall have, at a minimum, a Bachelor’s Degree in Nursing and five (5) years clinical experience.”; If there are no specific requirements that can only be performed by a RN, or a Bachelor of Science in Nursing, will the government consider allowing CRCs who are not RNs but are trained phlebotomists?

Answer: No. PWS calls for more than drawing blood (See paragraph 1.3.2.5)

15. Question: In regards to RFP Page 42: 1.4.2.7. “Shall have current Collaborative Institutional Training Initiative (CITI) training prior to starting work and shall maintain currency at all times.”; Will the government provide online access to the CITI training?

Answer: Yes.

16. Question: In regards to RFP Page 42: 1.4.2.7. “Shall have current Collaborative Institutional Training Initiative (CITI) training prior to starting work and shall maintain currency at all times.”; Which CITI courses will be required?

Answer: Both Group 1 – Biomedical Research Stage if applicable & Group 2 - Refresher.

17. Question: In regards to RFP Page 55: “1.5.8.4. Federalwide Assurance (FWA). The contractor shall demonstrate the possession of an active DHHS Federalwide Assurance (FWA) and a MPA DoD-Air Force Addendum…..”; It is our understanding that the DoD-Air Force Addendum is no longer required in addition to the DHHS FWA certification. Can the government remove the requirement for a MPA DoD-Air Force Addendum from the RFP?

Answer: Removed. See SF30 Addendum.

18. Question: In regards to RFP Page 171 3. Volume II – Technical Proposal 3.1 ii. “Technical Factor 2.4.2. - Evaluation of Compensation Plan for SCA covered employees: Laboratory Manager, Laboratory Technicians, Registered Nurses and Licensed Vocational Nurses”; Can the government clarify if a Laboratory Manager is required?

Answer: No. See SF30 Addendum.