Mobile PET-CT Lease Questions - Responses.docx

Mobile PET/CT Lease Questions

Vendor A Questions:

1. How often would it need to be moved? Would this requirement change if it needed to be moved weekly? The unit would be stationary in Temple. There may be a need to move to Austin in a few years and if we decide to relocate to Austin, it would stay in Austin for the duration of the contract. Any move would be discussed with the vendor before a decision was made.

2. Does the trailer title need to match the contracting vendor-company name? Would it be acceptable if a teaming agreement is in place with the entity providing the scanner? No the trailer title does not need to match the contracting vendor-company name. Teaming agreement is okay.

3. Is a mobile restroom adjacent to the scanner acceptable or does the restroom need to be inside the trailer? The restroom must be in the trailer.

Vendor B Questions:

1. Mobile PET/CT must be operational after contract award, pending completion of site prep work by VA when applicable for each location. Are there completion dates for Site prep? Current site is being utilized by a mobile MRI unit – once the MRI unit is removed the Mobile PET/CT can be installed.

2. The Vendor is responsible for the maintenance of the unit by an OEM FSE, including all Preventative Maintenance (PM), and all Parts and Labor. After each service the OEM FSE must provide a vendor Engineering Service Report (ESR) to Biomed staff. Must the service be done by the manufacturer? No, the service does not need to be done by the manufacturer. It is the responsibility of the contract to upkeep and service the machine.

3. The Mobile unit must be at a minimum size of 12’ wide x 48’ long to accommodate full access inside mobile unit and around PET/CT scanner. Can the mobile unit have pop outside that makes it 12 feet wide? Yes, if the trailer is able to expand to meet or exceed the dimensions.

4. Mobile unit must be Ground-Level, Flush-to-Surface Entry: Eliminates the need for wheelchair lifts or stairs, reducing fall risk, preventing lift malfunctions, and improving stretcher access. All trailers have twin beams, and axles that are below threshold level. How does the VA propose that the trailer can sit flush to the ground? If the unit requires a lift or stairs then the unit does not meet the requirements.

5. Regular wheeled trailers have operational hazards including tire blowouts, axle wear, and instability when stationary for long periods, posing additional maintenance and safety risks. Our required unit avoids these vulnerabilities entirely. All trailers have twin beams, and axles that are below threshold level. How does the VA propose that the trailer can sit flush to the ground? Again, if the unit requires a lift or stairs then the unit does not meet the requirements. If the elevation is fairly insignificant and a ramp is needed for entry – this is acceptable but the ramp would need to meet safety requirements for patients and staff. The ramp would also need to accommodate wheelchairs and stretchers.

Vendor C Questions:

#1--Location--Department of Veterans Affairs, Central Texas Veterans Health Care System,1901 Veterans Memorial Dr.

Temple, TX 76504-7451

1. Pad and power for the system? Is provided by the VA. The current pad is 150 amp at 480 volts

2. Site ready for the modular building or not? The site currently has a mobile MRI unit. The site is also not completely level and adjustments on your unit to level would need to be completed.

3. They say: P. 4—" The Vendor will provide all VA technologist staff appropriate training on the equipment.----How much training? And At Temple and Austin or just one or the other? At this time all training would occur at the Temple location. Training offered should be approximately two weeks. One week initial training with the option of training at a later date.

4. Apparently, NO TECHNOLOGIST, as they say in the bullet above, “VA technologist” The VA staff technologists will be operating the unit.

#2--Location--VA Austin Outpatient Clinic, 7901 Metropolis Drive Austin, TX 78744

1. Modular building or not? Or Fixed Mobile Coach? Temple, as of right now, is the only site this unit will be stationed. If the unit is needed in Austin, it will not be for a few years and will be discussed with the vendor before a decision to move is made.

2. Pad and power for the system? N/A at this time.

3. Timing for deliver? Same as Temple, which is 8-3-26, or different? N/A at this time.

4. P.8-it says: “Additional VA sites to be determined based on infrastructure availability and patient demand----are there more sites than Temple and Austin?---In this RFQ they say: “additional VA sites” Austin is the only other addition VA site and moving there is not definite.

Vendor D Questions:

1. How often will the PET move between sites? The unit will be stationary, if a move to Austin is needed, it will be a few years from now and will be discussed with vendor before a final decision is made. If it moves to Austin it will stay in Austin for the remainder of the contract period.

2. Does the Austin VA currently have PET services? If so, what system are they using and is it in-house or mobile? No Austin does not have PET/CT at the VA.

3. What PET system is currently being used at the Temple VA? GE Discovery

4. Is the current in-house system being replaced? If so, is there construction needed? The current system is past its life expectancy and is not affiliated with this solicitation.

Vendor E Questions:

0. Volume and operations

· What is the estimated weekly/monthly PET/CT volume by site (Temple vs. Austin), and what peak throughput and hours of operation (including any evenings/weekends) should we plan to support? Temple currently performs 23-30 PET/CT’s per week. Austin does not have PET/CT capabilities at this time.

· Estimated moves of the PET/CT Scanner to and from various locations (annually)? If the PET/CT changes location to Austin then it would only move one time, from Temple to Austin. It’s possible that the PET/CT stays in Temple for the entire contract period but if it moves to Austin then it would stay in Austin.

1. Site readiness

· Can you confirm that site prep (pad, power, data, and utilities) at Temple and any additional locations will be complete by the end of the 30‑day phase‑in, and who will be our primary VA contact for parking location and utilities coordination? Facility site prep is complete and ready to accept the unit. All contacts will be shared upon contract award at the kickoff meeting.

· Will VA provide any temporary staging or storage areas near the mobile unit for accessory equipment or supplies, and are there any local restrictions we should plan around? Temporary staging/storage can be discussed during kickoff call; however, there should not be a need since the trailer should be a dropped off and hooked up. As for restrictions, delivery will need to be planned for early morning or after hours, but can be discussed during kickoff.

0. IT/PACS and security

· Who will be our main IT/PACS point of contact for DICOM routing, VISTA Imaging integration, and NMIS connectivity, and are there any local security/network requirements beyond standard VA Handbook 6500 expectations? All contacts will be shared upon contract award at the kickoff meeting.

· Will VA require any additional cyber, privacy, or site‑specific training for contractor personnel accessing the mobile unit, beyond the standard VA annual training described in the solicitation? Not at this time.

1. Uptime, QC, and physics

· How would you like us to document uptime/downtime and any applicable pro‑rated credits when outages exceed 48 hours, and are there any local QC or physics protocols (in addition to ACR/JC) that you want us to follow? All downtime should be communicated through the COR. Any additional QC or protocols will be discussed after the award during the kickoff meeting.

1. Roles, training, and COR oversight

· Can you confirm the division of responsibilities between VA technologists and contractor staff for patient flow and scanning, the number of staff needing OEM training, and who will serve as COR/alternate COR and preferred communication method for performance discussions? No contract staff is needed/required. We currently have 4 PET/CT technologists at the Temple VA. All key players designated for communication will be identified after award at the kickoff meeting.

Vendor F Questions:

1. Please clarify the VA’s expectation and applicable regulatory basis regarding radioactive patient waste handling and sewage discharge from the PET/CT unit. Once the unit is connected to the facility sewer system, does the VA consider patient waste managed under the facility’s existing radioactive materials program, or is the contractor expected to provide a dedicated shielded or monitored holding tank for radioactive black water retention? The water/sewage hookups will be provided by the VA and therefore under the VA’s per view. There should be no need for a holding tank.

1. Please confirm the anticipated relocation frequency of the PET/CT unit during the base and option periods, including any planned moves between Temple, Austin, or future VA sites. The unit will be stationary in Temple. If a move to Austin is needed after a few years, it will be discussed with the vendor. This move would only happen once and if it moves to Austin then it would stay in Austin.

1. Please confirm whether all identified and future scanning locations currently have approved site infrastructure, including electrical service, data connectivity, water, sewer, and site access sufficient for PET/CT operations. Temple – yes. Austin – Not at this time.

1. Please clarify whether the Government or the contractor is responsible for any required site preparation, including concrete pads, bollards, utility trenching/connections, or environmental protections. Government completed site preparation. The contractor will need to hook the unit up to existing utilities.

1. In section 4. Preventative Maintenance/Repairs, "Any event the system is unoperated beyond 48 hours, the vendor will offer the pro-rated rate of" Is this in reference to the PET/CT being down due to service/repairs or if the VA does not have a patient in 48 hours, the ask is for the contractor to pro-rate the use? This is if the unit is down and not able to scan patients. If we do not have patients to scan this is not applicable to you.

1. Please confirm whether the requirement for “Ground-Level, Flush-to-Surface Entry” prohibits marginal ramps to cover thresholds and slight differences in grade to doorway? Ramps are acceptable but must be safe for patients/staff, wheelchairs, and stretchers.

1. Please clarify whether the Government requires a patient lift system for transfers onto the PET/CT table. If required, please confirm preferred configuration (portable or ceiling-mounted), preferred OEM, and minimum patient weight capacity. It is not a requirement to have a lift to the PET/CT table.

1. Please confirm whether a patient table rated at a lower weight would be acceptable if all other clinical and safety requirements are met. No – patient table must meet or exceed requirements with the SOW.

1. Please clarify whether the Government requires a CT contrast injector. If so, please confirm preferred OEM and whether the injector should be cart-mounted or ceiling-mounted. This is not a requirement.

1. Please clarify whether the Government expects the contractor to provide an FDG injector system, such as a MEDRAD Intego, or whether the VA will supply and manage its own injector. This is not a requirement.

1. Please confirm the expected Hot Lab configuration and whether the Government has a preferred equipment list, shielding design, or OEM standard. The hot lab must be shielded and a stand alone room with space for dose tracking system, wipe counter, dose case storage/shelves, and the ability to close/lock the hot lab.

1. Please clarify whether the contractor or the VA Radiation Safety Officer will maintain custody and accountability of radioactive materials and isotopes during operations. The VA RSO.

1. Please clarify the requirement for the contractor to maintain a RAM license if the VA will manage, staff, control, and retain radioactive materials on-site. Vendor is responsible for RAM until system is accepted by VA

1. Please clarify whether the contractor is responsible for all PACS, DICOM, MIM, Cedars, AW workstation, and VistA integrations, or whether VA IT personnel will assist with network configuration and cybersecurity approvals. VA staff will assist.

1. Please confirm whether the Government will permit OEM-certified hard-drive wiping and sanitization at contract completion in lieu of physical hard-drive turnover. No - the hard-drive will be removed.

1. Please clarify whether the contractor should include replacement costs for all retained storage media within the lease pricing structure. This should be decided by the vendor.

1. Please clarify whether offerors may propose equivalent PET/CT systems that do not precisely match the listed Siemens or GE examples but meet or exceed all functional requirements. Yes, if it meets or exceeds.

1. Please confirm whether the Government has any preference regarding OEM platform standardization with existing VA Central Texas imaging equipment. This is not a requirement.

Vendor G Questions:

1. Will the Government consider a Siemens Biograph Trinion PET/CT as meeting the salient characteristics in SOW Section B? I would need to be provided with all the specifications of the unit to answer this.

2. The SOW states the vendor is responsible for transporting the unit to and from the determined locations and identifies Temple as the base location with Austin as a possible additional site. Will the unit move between Temple and Austin on a recurring basis, or remain primarily stationary at Temple with relocation exercised only as needed? If recurring movement is anticipated, can the Government provide the expected relocation frequency or schedule so transportation costs can be accurately reflected in the monthly lease rate? The unit will be stationary at the Temple site for now. In a few years we may discuss moving the unit to Austin but at this time it will be staying in Temple. If it is decided to move the unit to Austin then the unit would stay in Austin.

3. The SOW states the vendor must hold a Texas radioactive material license with NRC reciprocity, while also stating that VA staff will be responsible for scheduling and imaging patients. Please clarify whether the Government expects the vendor to hold the radioactive materials license, or whether radiopharmaceutical use and patient imaging will be conducted under the VA's existing radioactive materials authorization. Vendor is responsible for RAM until system is accepted by VA

4. Section A specifies a ground-level, flush-to-surface, stationary "no-wheel" modular-like build. Please confirm whether a conventional wheeled mobile PET/CT coach is excluded. Yes – the traditional wheeled units are not in scope for this requirement.

5. Is the hand-washing sink a mandatory requirement of the unit? Yes.

6. Must the restroom facilities be integrated inside the unit itself, or would access to adjacent VA restroom facilities satisfy this requirement? Yes, the restroom must be inside the mobile unit.

Vendor H Questions:

17. The SOW references “Siemens Vision PET/CT, GE Discovery, or Digital PET/CT Scanner.” Would the Government consider older-generation PET/CT systems utilizing time-of-flight capability and meeting all other operational/performance requirements acceptable if they are not classified as newer-generation digital PET systems? Any system older than 3 years will not meet requirements.

17. Is the requirement that the mobile unit be “at most 3 years old” applicable strictly to the trailer/mobile platform itself, or does that requirement also apply to the PET/CT scanner equipment installed within the unit? This is a requirement for both the mobile unit and the scanner.

17. Would the Government consider technically acceptable refurbished or OEM-remanufactured PET/CT systems provided they meet all performance specifications and ACR accreditation requirements? This would not be preferred.

17. Is there an incumbent currently performing these services? If so, can the Government provide the current contract number and incumbent contractor name? No, we do not currently have mobile PET/CT.

17. The solicitation references possible additional deployment locations. Can the Government provide any estimated frequency or anticipated duration for relocations outside the Temple, TX location? The unit will be stationary at the Temple site for now. In a few years we may discuss moving the unit to Austin but at this time it will be staying in Temple. If it is decided to move the unit to Austin then the unit would stay in Austin.

Vendor I Questions:

1. Is this a brand new contract or if there was an incumbent performing services?

· If not brand new, could you please provide the current/previous contract number?

The current contract number is 36C25722P0555.

Vendor J Questions:

1. Does the Government consider Solicitation 36C25726Q0502 to be a contract for services, or a mixed contract for services and supplies, for purposes of the limitations-on-subcontracting calculation under 13 CFR 125.6? Solicitation 36C25726Q0502 is considered to be a contract for services.

2. For the 50% limitation applicable to the services portion, will the cost of the leased mobile PET/CT unit and associated capital equipment be treated as a direct cost or cost of materials that is not the principal purpose of the acquisition and therefore excluded from the base, or will the full amount paid by the Government under the lease line items constitute the base against which the 50% limitation is measured? Please see C.8 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023) (DEVIATION) in the solicitation.

3. Will the Government confirm the methodology an offeror should use to demonstrate compliance with the limitations on subcontracting for this requirement, so that all offerors apply a consistent basis in their certifications and pricing? If the vendor is leasing the equipment, then payment to the vendor is considered.

36C25726Q0502 0001