Questions and Answers.docx

Questions and Answers Autoclave Temperature Mapping, Cycle Development, and Cycle Validation

1. Question: Has the IQ/OQ been performed?

a. Answer: This performance work statement is for the PQ only.

2. Question: How is placement of the probes going to be determined during heat mapping? Does a rigging need to be built?

a. Answer: The contractor should base the probe locations on 2 factors. The first factor is to get the optimal characterization of the temperature trends in the chamber. The second factor is to capture the temperature trend where an autoclave waste bag will be located which is restricted by the size of the autoclave chamber cart and the location/size of an autoclave tray (approximately 14”x18”), a minimum of 8-24 locations, depending on the autoclave model. Contract may use autoclave carts provided by the Government as a part of the rigging. Any additional rigging will be provided by the Contractor.

3. Question: Is floor covering required?

a. Answer: No, floor covering is not required.

4. Question: Can the contractor use NBAF carts to move material?

a. Answer: NBAF will provide carts for movement of materials.

5. Is a bond required?

a. Answer: No, bonding is not a requirement.

6. Can NBAF provide paperwork listing the grouping of the Autoclaves:

a. Answer:

7. How is the material going to be stored and or staged to minimized delays?

a. Answer: NBAF will provide a staging area within a reasonable proximity to the area of work.

8. Any cycles programed on the autoclaves now?

a. Answer: Yes, cycles are pre-programed. Manufacturer “Program Combination Sheet” and a service pin will be provided to modify the basic run parameters during the cycle development phase.

9. How often have the autoclave units been used, has preventive maintenance been done?

a. Answer: The autoclave units have seen minimal use and are current on calibration and preventative maintenance.

10. Who provides PPE

a. Answer: PPE will be provided by NBAF as necessary.

11. Can NBAF provide manufacturer user guides and/or manual.

a. Answer: Yes, NBAF will provide the manufacturer operation manuals.

12. Please confirm contractor is not required to perform Installation Qualification and Operational Qualification for this contract.

Answer: The contractor is NOT required to perform IQ or OQ.

13. Will a project tax exemption certificate be provided for this project?

Answer: Yes

14. The government provided scope of work states temperature mapping will include 3M Attest Challenge Pack in predetermined locations. Please provide this location information.

Answer: The locations for the PCD packs vary depending on the autoclave model.

· For GE 122222 ARB-2: There are 24 locations total for PCD packs. Each location is at the center of where an autoclave tray will reside on a shelf; 4 trays per shelf; 3 shelves per rack, 2 racks.

· For GE 6610 AR-1, GE 6610 ARB-2, GEQ 6610 ARC-1, GEQ 6610 ARC-2, GEB 6913 ARB: There are 4 locations total for PCD packs. Each location is at the center of where an autoclave tray will reside on a shelf; 2 trays per shelf; 2 shelves per rack, 1 rack.

· For GE 6915 ARB-2: There are 8 locations total for PCD packs. Each location is at the center of where an autoclave tray will reside on a shelf; 4 trays per shelf; 2 shelves per rack, 1 rack.

15. If PPE is required to access spaces, is contractor to assume USDA will provide? Will work personnel be required to shower in and out of areas?

Answer: Yes, on PPE Answer: No, on shower

16. Will any animal studies be occurring in any of the areas during this contract that may impede workflow?

Answer: There may be some non-infectious animal studies occurring during the POP. If so, BRM will work with the contractor and ARU to mitigate any disruption to workflow.

17. Is contractor allowed to work on/access multiple autoclaves at once?

Answer: Yes.

18. Please confirm if routine maintenance has been performed on the units to be validated? Is contractor to assume each unit is fully functional? Is the contractor to assume stop work if it is determined a unit needs repair before validation can occur?

Answer: Yes, PMs will have been completed for each autoclave and BRM will perform a Bowie Dick test on each autoclave. If any units need repair, BRM will work with Facilities to ensure those repairs are completed before the contractor will be asked to validate the autoclave.

19. Please confirm contractor is not responsible for any repairs for this proposal.

Answer: The contractor is not responsible for any repairs related to this proposal.

20. Does the USDA have all passwords assimilated for access to autoclave control panels for changing of programming?

Answer: Yes.

21. Will USDA provide all carts required for getting equipment transported around the facility? Will offsite equipment be allowed onsite and then back offsite (i.e. carts, temperature probes, data loggers, etc.)? Or will USDA provide these items? If contractor is responsible for their own carts, what types of wheels will be required to not damage the flooring?

Answer: Government will provide needed carts; other equipment will be on a case-by-case basis.

22. Will the USDA award every CLIN item? Or will it opt to pick and choose different CLIN’s at its discretion for award?

Answer: Government expects to award all CLINs of this contract at one time.

23. Is the USDA amenable to extending the period of performance to a minimum of 280 days? More would be preferred.

Answer: No, key milestones will be miss if extra days are added.

24. Can a 1-week extension be provided for the proposal?

Answer: See Amendment 0003 for quote closing time/date.

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