Answers to questions FDA-FY22-SOL-1254387.pdf

Answers to questions for FDA-FY22-SOL-1254387

1. Is it possible to provide an extension for submissions past the July 7th due date? a. We would like to due this for various reasons, including the site-preparation information

Answer: The solicitation will be extended to July 15, 2022

2. Are you open to a technology presentation?

Answer: NO, we don’t think we need to have presentation from the vendors since are aware of the various technologies.

3. Are there already systems installed? Will you be needing to trade in a system or have a system removed? If so, can you provide information on the system?

Answer: YES we have systems installed. NO, we are not making a trade, NO systems need to be removed.

4. Is a site visit possible to be able to provide accurate site preparation cost? Will you need turn-key construction cost?

Answer: POSSIBLE but we don’t feel it should be necessary. We can send a picture of the lab room (attached) and we’ll have power/shielding etc. already in place. So system just needs to be placed and connect to the power source. This is a research system and will be placed in a research lab. No patients will ever be imaged.

5. Is the FDA looking for new or refurbished systems?

Answer: New or refurbished is fine but should be a 2018 or later model.

6. Does the tomosynthesis system need to be High-Definition?

Answer: NO (we aren’t exactly sure what this means so more information may be helpful to clarify)

7. Does the tomosynthesis require: a. Synthetic 2D imaging?

Answer: YES,

a. Synthetic 3D imaging?

Answer: NO, (but we are not clear on what synthetic 3D this is so again more information this might be helpful)

8. 8. Where will this be installed? Can pictures be provided? Do you have room drawings?

Answer: System will be installed in mammo lab in WO62-3101. YES, picture attached, No (but we will get them if necessary).

9. Is the FDA able to elaborate what testing methods will be defined? a. Can you elaborate on the image quality parameters that are being assessed?

Answer: Not clear why this is need by the vendor to put in a bid. This seem more related to the research activity we will perform on the system when in the labs.

10. Performance and validity for DBT systems must consider various factors, including:

including dose, DBT Angular range, acquisition technique, number of projections, reconstruction methods à how are these being accounted for in this Solicitation and are there any minimum requirements?

We believe that solicitation is written as such, that this does not allow for full and open competition:

a. Is Step-and-Shoot the only gantry movement allowed?

Answer: We requite step-and-shoot movement to allow experiments that minimize focal spot blurring during acquisition

b. Is CsL detector the only type allowed.

Answer: We requite CsI detectors because they have lower noise and again facilitate our research activities.

11. In addition to system training, will you need training for a biomed service engineer?

Answer: NO

12. Does the FDA intend to utilize the cybersecurity requirements (medical RMF) utilized by the Defense Health Agency? If not, what is the cybersecurity standard, and can the FDA provide a written copy?

Answer: We do not support “medical RMF” utilized by the Defense Health Agency. Rather, FDA systems follow FDA Information Security and Privacy Protection (IS2P) policy which is based on Federal Information Security Modernization Act (FISMA) of 2014; National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, revision 5, Security and Privacy Controls for Information Systems and Organizations.

13. Will this system be used for clinical use?

Answer: NO

14. What will be the storage solution for the FDA? As well as the long- term storage?

Answer: FDA ha sit’s own internal storage system for both long and short-term image storage. This is not a PACS but a server where images are downloaded too.

15. Can you please let us know what type of reading solution the FDA utilizes?

Answer: Images are viewed on a standard computing workstations using a 3rd party tools. This is not a PACS system.

16. Will there be any patient imaging? If so, will you require CAD?

Answer: NO, only phantom imaging for research purposes. CAD is not required.

17. Pertaining to Warranty and Maintenance section, is the FDA requesting Biomed training to be included in the proposal? And can you please define what needs to be included in training?

Answer: Not exactly clear on what Biomed training would encompass . We do require training for 3-4 engineers/physicists to use the system to acquire images and to do the appropriate calibrations and quality control.

18. Pertaining to the Period of Performance section, are you asking that we include a 4-year service contract?

Answer: No. The entire system shall be warranted for parts and labor for at least 12 months from the date of acceptance.

19. Regular business hours state 10 am to 8 pm EDT, where will this unit be going?

Answer: System will be installed in a mammography research lab in WO62-3101.

20. What is the network bandwidth (LAN and WAN)?

Answer: 1G currently with 10G likely coming in the future.

21. How is the site intending to read - PACS vs. Standalone Workstation?

Answer: Standalone Workstation.

22. Will this system be placed on the network – if yes, what is the network speed?

Answer: 1G currently with 10G likely coming in the future.

23. Will Turnkey/Scope of Work (room construction) be managed by the customer or should the vendor account for it in our offer?

Answer: Room construction/configuration will be manged by customer. This does not need to be included in the offer. 1G currently with 10G likely coming in the future.

24. Will you require Mag Stand, Spot Paddles or 2D Localization?

Answer: NO for all