Attachment D - W81K0024R0011 Question_Answer.pdf

W81K0024R0011 Question & Answer

1. Pricing sheet - Attachment C – are the numbers provided for each year or for the full 5-year term?

Government Response: Solicitation Attachment C identifies the maximum quantities anticipated for the 5-year ordering period.

2. It is correct that there then will be a different CPRR for each Equipment Description on attachment C?

Government Response: It is upon the vendor to propose CPRRs based on each equipment description to meet the requirements of the Statement of Work.

3. What equipment does the 500,000 slides refer to in section 9.12, & 9.15?

Government Response: See updated Statement of Work via Amendment 0001.

4. If IHC, can you confirm that it’s 500,000 slides per year or is this 500,000 slides for 5 years? Sections 9.12-9.15 indicate year.

5. Section – 9.16 - what equipment does this reference? Can you further describe the requirement and length of time of intended storage? Our reagents are proven stable at room temperature for standard run times, over night and weekend / holiday runs.

Government Response: The equipment at Statement of Work section 9.16 refers to IHC.

6. If the equipment (qty 3) cannot support the volume of 500,000 slides, can vendor add more equipment?

Government Response: Vendor must propose a solution to meet the requirements of the

Statement of Work.

7. Are there any other IHC instrument requirements/needs other than on board temperature control?

Government Response: The Statement of Work does not require on board temperature control;

Section 10 refers to Packaging and temperature control requirements for all Reagents and

Supplies.

8. Is there an expected growth of volume over the 5 years?

Government Response: Growth has been anticipated in the total maximum quantities identified at Solicitation Attachment C.

9. Will there be any capital purchase or will they all be CPRR?

Government Response: All CPRR; no capital purchases will be made.

10. What is the expected way to calculate CPRR for digital scanner? Will vendor invoice at a certain interval quarterly?

Government Response: The calculation is to be per slide. Vendor will invoice in accordance with Invoice Instructions included in the solicitation and resultant contract.

11. If vendor does not offer an automated Special Stain solution, can vendor still bid on the IHC, H&E and Whole slide imaging?

Government Response: Yes, see updated Statement of Work via Amendment 0001.

12. Regarding MHS capability and RMF compliance, are you seeking to purchase this or are you just asking if we can work with these systems?

Government Response: No, the Government is not seeking to purchase RMF or MHS. The

Government requires RMF compliance and MHS capability as identified in the Statement of

Work.

13. RMF compliance – is there a risk assessment or would our approved ATO be sufficient?

Government Response: Completion of Solicitation Attachment B3 is required regardless of current ATO. RMF requirements are contained in the Statement of Work.

14. Can an extension be granted given the magnitude and complexity of this solicitation?

Government Response: The proposal due date and time is extended as identified via

Amendment 0001.

15. Cybersecurity Assessment Questionnaire – will this be filled out for GT450 + SAM or an

IHC product or needs to be filled out multiple times for multiple products?

Government Response: Solicitation Attachment B3 is for the entire system/package.

16. Given how extensive the requirements for this bid are, would BAMC consider moving the clarifying question deadline from 5/2/24 to 5/16/24?

Government Response: The Government will not provide an extension for submission of technical questions.

17. In order to ensure we have time to create a high-quality response for your review, would

BAMC consider moving the RFP deadline from 05/13/24 to 06/14/24?

Government Response: See Answer to Question #14.

18. Would the BAMC consider a Cost Per Test pricing model for this opportunity

Government Response: No.

19. Would the BAMC consider a pricing model based upon the purchase of bulk materials, consumables, etc?

Government Response: No.

20. IS a cloud-based solution acceptable in reference to section 9.17. If a cloud-based solution is not acceptable, on premise will be required, can BAMC provide their own servers?

Government Response: Cloud based not preferred. Yes, the Government can provide its own servers. See updated Statement of Work via Amendment 0001.

21. In reference to 9.17: Does the genesis system (LIS) support a fully qualified HIL message?

Government Response: See Statement of Work Section 9.17. DHA uses HL7 language protocol.

22. In reference to Section 9.3, would the BAMC consider a system that includes instrumentation wherein HE is run on a single instrument, special stains are run on a single instrument, and

IHC/ISH is run on a single instrument (rather than one instrument running both HE and special stains)?

Government Response: Yes, the Government would accept this type of system or a hybrid option manual Special stains with option to rundown and coverslip with automation. See updated Statement of Work via Amendment 0001.

23. Section 1: The machines must be in operational status for processing samples 98% of the time during the department’s hours. Clarify how you determine and track the 98% threshold.

Government Response: Refer to Statement of Work Section 17.

24. Section 3.5.2: We request this requirement to be removed.

Government Response: This paragraph of the Statement of Work Section 3.5.2 will not be removed.

25. Section 9: "repair/replace any unsatisfactory instrumentation listed in this section". What criteria is used to define unsatisfactory.

Government Response: Refer to Statement of Work Sections 13.3.8.2 and 13.3.8.4.

26. Section 9.12: Clarify which instruments will run 500,000 slides per year?

Government Response: See Updated Statement of Work via Amendment 0001.

27. Section 10.10. We believe linearity materials are not applicable to this requirement, we request this requirement to be removed.

28. Based on our experience and understanding of method validation requirements for this testing category (Anatomical Pathology), sections 11.4.2 are not applicable. we request this requirement to be removed.

29. Please remove or revise the reference to 12.4.2 in sections 13.3.8 & 13.3.8.1, as it doesn't exist.

30. Please remove or revise the reference Levy-Jennings charts in section 9.17.2, it is not relevant to this RFP.

31. The standard pricing model for this testing category (Anatomical Pathology/Histology) is cost per test. This model would integrate all costs as outlined in Section 1. Please provide a more detailed definition for your proposed calculations.

32. If vendor can comply with 9.17 with an on-premise virtual server? In our response we should stipulate the expectation in our response.