36C10G18Q0079-001.docx

PRODUCT DESCRIPTION

DEPARTMENT OF VETERANS AFFAIRS

Strategic Acquisition Center

Surgical Lights and Booms Date: 11/2/2017

1. Contracting Officer’s Representative (COR)

Phone Number:

Fax Number:

E-Mail Address:

2. Contract Title. Surgical Lights and Booms

3. Background The Louis Stokes Cleveland Veterans Affairs Medical Center (LSCVAMC) is completing a two-part construction project for the upgrade, expansion, and implementation of two (2) Hybrid Suites, and seven (7) standard operating rooms. Each project holds separate construction milestones, and have separate installation needs/requirements. The current lights and booms are at the end of life and have been failing on a regular basis. Biomedical Engineering is unable to continue to maintain the lights and booms systems currently in place, as they have become beyond economical repair, as well as, the inability/difficulties in obtaining repair parts for servicing the systems.

4. Scope This contract is entered into pursuant to FAR Part 12, Acquisition of Commercial Items. The LSCVAMC requires a contractor to manufacture, deliver, assemble, and install the two (2) Hybrid Suites. The LSCVAMC will ONLY require the delivery of the seven (7) standard operating rooms. The LSCVAMC is asking that all lights and booms be manufactured in accordance to the room dimensions that are provided via CAD drawings within this solicitation. The required manufacturing, delivery, assembly, and installation services of the two (2) Hybrid rooms is further discussed within section 5.2 of this document. The required manufacturing and delivery ONLY of the seven (7) standard operating rooms is further discussed within section 5.2 of this document.

5. Specific Tasks

5.1 Task 1 – Delivery of Equipment and Supplies/Description of Deliverables

Surgical Head Light Requirement:

· The Cleveland VAMC requires the implementation of surgical head lights within seven (7) standard OR rooms and two (2) Hybrid Suites. The requested surgical head lights shall be light emitting diode (LED) lighting technology on all provided surgical head lights for each of the seven (7) standard OR rooms, as well as, the two (2) hybrid suites must be outfitted uniformly with the same model of lights per room.

· The surgical head lights shall provide a consistent illuminated surgical field and clearly exhibit the ability to resolve and mediate physical obstructions by redirecting illuminance via either structural design or sensory technology.

· The surgical head light shall provide an even light source at varying distances/depths within the surgical field, as well as, the ability for the user, i.e., surgeon to adjust the surgical field/concentrated area manually during use without breaking the sterile field. Depth of field range can be no less than, but not limited to 30 inches, with an approximate, but not limited to a field size of 6.0 inches to 10 inches.

· The surgical head lights shall provide a variety of illumination levels, with a continuous maximum intensity of no less than 160,000 luces, as well as, laparoscopic lighting capabilities.

· The surgical head lights shall provide four color temperatures which can be adjusted to provide contrast while working in several types of tissues. The requested color temperatures shall range from 3.6000 to 5.000k.

· The surgical head lights shall be operational/adjustable at a main control wall mounted panel near the nurse’s desk (existing ORs) or control room (two (2) hybrid ORs), as well as, within the sterile surgical field. Within the the two Hybrid ORs the head lights must be controllable by three sources, these include, the control room, the nurse station, and sterile surgical field. Requested adjustment capabilities shall include, but not be limited to, the brightness of the light and the concentration of the light. Additionally, the surgical head lights must be able to be controlled from the lighting assembly by users without the need to break the sterile surgical field.

· The surgical head lights shall be equipped with an integrated high definition camera. This camera shall provide/support no less than 1080i and be compatible with all technology currently utilized within the Surgical Suites. This includes hd-sdi and DVI, and VGA connections.

· The surgical head lights shall be ceiling mounted with unrestricted rotations for freedom of movement (360 degrees) at all 4 rotation points on lighting boom.

Surgical Equipment Management Systems:

The Cleveland VAMC is requiring equipment management booms to be installed within seven (7) standard OR rooms and two (2) Hybrid Suites.

The following breakdown is related to the number of specific booms within each OR:

· OR Rooms Four (4) through Seven (7):

· Two (2) display monitor arms each

· Two (2) light arms each

· One (1) equipment boom each

· One (1) anesthesia boom each

· OR Rooms One (1) through Three (3):

· Three (3) display/monitor arms each

· Three (3) light arms each

· One (1) equipment boom each

· One (1) anesthesia boom each

· One (1) perfusion boom each

· Hybrid OR Rooms One (1) and Two (2):

· Two (2) display/monitor arms (capable of holding 26” monitoring equipment) each

· Two (2) display/monitor arms (capable of holding 59” HD monitoring equipment) each

· Three (3) lights arms each

· Two (2) lead shield arms each

· One (1) equipment boom each

· One (1) anesthesia gas service boom each

· One (1) perfusion boom each

Display/Monitor Arm System Requirements:

· All display/monitor arms shall be compatible with and able to accept any manufacturers’ integration video cables. The arms must be hollow to allow for the pulling of integration cables through each arm. The contractor shall provide the interior diameter of their display arms to ensure this need is being met and that sufficient room is present to pass the current video integration cables used within each OR.

· The standard display/monitor arms located within the two (2) Hybrid ORs shall support a minimum of a 26” display monitor to a maximum of a 34” display monitor with Standard Video Electronics Standards Association (VESA) mounting bracket.

· The 59” HD display/monitor booms within the two (2) Hybrid ORs shall be articulating, i.e., capable of moving up, down, and side to side.

· The display monitor booms must be able to rotate around the surgical field, parallel to the table at any orientation. This means the monitor is capable of rotating in a manner which will allow the display to be visible and rotate around all patient positions on the surgical table.

Anesthesia Gas Service Boom Requirements:

· All anesthesia gas service booms shall be articulating, i.e., capable of moving up, down, and side to side.

· All anesthesia gas service booms shall be equipped uniformly with either electrical or pneumatic brakes. No friction brakes will be deemed acceptable for use. The Government prefers electrical braking systems. Electrical braking systems will be valued more favorable during grading due to the ease of use and enhanced safety.

· All anesthesia gas service booms shall be equipped with a minimum of at least eight (8) duplex power outlets.

· All anesthesia gas service booms shall be equipped with a minimum of two (2) shelves. Contractor shall provide load capacity so that a determination can be made that shelving is capable of accommodating required medical equipment.

· All anesthesia gas service booms shall provide the following IT related connections:

· Two (2) wall plates equipped with four (4) data jack ports each for patient monitoring.

· Video input wall plate with Digital Visual Interface (DVI) video, Video Graphics Array (VGA), and composite video inputs.

· All anesthesia gas service booms shall support the following gases:

· The government reserves the right to increase the quantity of gas outlets after award. The final quantities shall be determined at the installation of each OR.

Equipment Service Boom Requirements:

· All equipment booms shall be equipped uniformly with either electrical or pneumatic brakes. No friction brakes will be deemed acceptable for use. The Government prefers electrical braking systems. Electrical braking systems will be valued more favorable during grading due to the ease of use and enhanced safety.

· All equipment booms shall be articulating, i.e., capable of moving up, down, and side to side.

· All equipment booms shall be equipped with a minimum of four (4) shelves.

· All equipment booms shall be equipped with a minimum of ten (10) duplex power outlets, with each outlet being of its own circuit breaker at a minimum of twenty (20) amps each.

· All equipment booms shall be capable of providing a load capacity of no less than 475 to support Medical Equipment.

· All equipment booms shall support the following:

· Light source

· Insufflator

· Camera Control Unit (CCU)

· Electrosurgery (ESU)

· Integrated support for Nitrogen, Nitrous Oxide, Oxygen, Medical Air, Vacuum and Medical Waste gas.

· Video input wall plate with Digital Visual Interface (DVI) video, Video Graphics Array (VGA), and composite video inputs.

Hybrid Boom Mounted Lead Shield Requirements:

· Lead shield booms shall be provided that will support lead shields on each side of the patient within the two (2) Hybrid ORs. Each of the Hybrid ORs will require no less than two (2) lead shields. The lead shield must be capable of being positioned and moved along the length of the table regardless of operating orientation.

· The contractor shall provide four (4) lead shields to be mounted with the above stated lead shield booms.

Perfusion Service Boom Requirements:

· All perfusion booms shall be articulating, i.e., capable of moving up, down, and side to side.

· All perfusion booms shall be a double armed boom system capable of supporting a minimum of two (2) medical air gas outlets, two (2) oxygen medical gas outlets, four (4) Medical waste gas outlets, and be equipped with six (6) 110v duplex outlets.

5.2 Task 2. Installation and Assembly

Awarded Contractor Responsibilities The below breaks down the two-part construction project and the designated responsibilities of the awarded contractor and LSCVAMC in relation to the requested lights and booms systems needed to outfit the two (2) Hybrid Suites and seven (7) standard operating rooms. Each project holds separate construction milestones and have separate installation needs/requirements.

As noted above within the scope, the LSCVAMC requires a contractor to manufacture, deliver, assemble, and install the two (2) Hybrid Suites. The contractor shall ONLY manufacture and deliver equipment for the seven (7) standard operating rooms. The seven (7) operating rooms require NO installation or assembly services under this solicitation.

All lights and booms shall be manufactured in accordance to the room dimensions that are provided via CAD drawings within this solicitation.

Hybrid Suites The contractor shall be responsible for completing the manufacturing, delivery, assembly, and installation of the lights and booms for each of the two (2) Hybrid Suites. Within 10 calendar days after award, the contractor shall provide a detailed structural drawing and specification sheet of their offered equipment and its associated components. The LSCVAMC will have a third-party construction contractor already on site completing other work prepare the internal structure and install the proper load bearing plates and mounts in the individual operating rooms in accordance with the information provided via the manufacturer’s structural drawings and specifications. This onsite work is anticipated to take no less than 30 calendar days. The contractor will not be responsible for providing any onsite structural framing, plates, mounts, or unistructural for the mounting/installation activities. The LSCVAMC will also be responsible for the plumbing, gas, and electrical workmanship. The LSCVAMC will provide these sources within each of the two (2) Hybrid Suites. The awarded contractor shall install the lights and booms to the internal structure only AFTER it is prepared by the LSCVAMC for equipment installation. Therefore, prior coordination with the COR is required no less than 14 calendar days in advance of the anticipated delivery. Onsite assembly and installation will be accomplished within 14 calendar days of delivery.

Assembly includes any uncrating & assembling of each boom and lighting system and any other associated components necessary for proper installation. The contractor will assemble all deliverables, i.e. components in association with their products so the boom and lighting system is built in full for installation by the awarded contractor.

The contractor is responsible for installing the lights and booms within each of the two (2) Hybrid rooms following assembly. Installation refers to taking the fully assembled booms and surgical lights and mounting them to the internal structure which will be retrofitted with the proper mounting plates and hardware in accordance to the contractor’s provided drawing and specification sheets presented to the LSCVAMC upon award as noted above. The contractor is fully responsible for the installation site services and the mounting of their booms and lighting system to the prepared internal structures within each of the two (2) Hybrid Suites. The contractor is responsible for the quality of their services within the two (2) Hybrid Suites and held responsible for the proper functionality of their equipment. As noted below, the Medical Center Engineering staff will complete acceptance testing and deem whether the installed lighting and booms systems within each of the two (2) Hybrid Suites is acceptable for use.

The contractor is responsible for maintaining the integrity of the internal structures such as flooring and walls within each of the two (2) Hybrid Suites and surrounding locations. The contractor shall maintain a clean working environment and clear their work area of all debris and equipment upon completion of the assembly and installation services. The contractor will be held financially responsible for any damages incurred due to their direct negligence within not only the working zone of the two (2) Hybrid Suites but any other area within the LSCVAMC that they encounter during their assembly and installation services.

Standard Operating Rooms The contractor shall be responsible for completing ONLY the delivery of the lights and booms for the seven (7) operating rooms. Upon award, the contractor shall provide a detailed structural drawing and specification sheet of their equipment and all components to allow the LSCVAMC the ability to prepare the internal structures properly through a third-party contractor. The LSCVAMC is ONLY requesting within this solicitation that the award contractor deliver the equipment to the LSCVAMC. These systems will be stored at the cost of the Government and later installed at the discretion of the Government under its separate maintenance and operation construction project which will be completed around the construction milestones of that project and in accordance to Surgical Services schedules.

Medical Center Engineering (Internal) Responsibilities The LSCVAMC will be responsible for providing any structural framing, plates, mounts, or unistructural for retrofitting the two (2) Hybrid Suites for the final installation site services that will be completed by the contractor as noted above. The LSCVAMC will also be responsible for the plumbing, gas, and electrical workmanship. The LSCVAMC will provide these utility sources within each of the two (2) Hybrid Suites.

Inspection services will be performed in house by the LSCVAMC Biomedical Engineering and Construction Engineering staff to ensure the proper assembly, mounting, and functionality of the lighting and boom systems upon the completion of the above installation services completed by the awarded contractor. Testing shall include any tasks determined necessary to ensure the lighting and boom systems are free of craftsmanship and operational defects, and that all component parts are functioning within manufacturer’s specification, as well as, installed properly to ensure the safety and functionality of the equipment. Engineering staff will determine if testing results are satisfactory for acceptance and determine the equipment fit for use. The contractor is responsible for the quality of their services within the two (2) Hybrid Suites and held responsible for the proper functionality of their equipment.

The LSCVAMC will be responsible for the plumbing, gas, and electrical workmanship. The LSCVAMC will provide these sources within each of the two (2) Hybrid Suites.

5.3 Task 1. Warranty

The vendor will provide a one (1) year warranty on all parts and labor for the lights, booms, and additional supplies after installation site services are found acceptable for the two (2) Hybrid Suites. A standard one (1) year manufacturer’s product warranty is required for the (7) standard operating rooms. The government requests this warranty to begin after installation by the third party contractor, not upon delivery to the government facility.

5.3 Task 2. In-Servicing: Clinical Staff and Biomedical Staff Training The contractor shall provide and facilitate end user and Biomedical training appropriate for use of the replacement operating rooms and Hybrid Suites. The Training plan shall be developed 4-6 weeks before delivery with Nursing Education and Contracting Officer Representative (COR). Initial in-service training shall be accomplished seven (7) calendar days after acceptance and installation of the first delivery of lights and booms.

End User Training: Basic familiarity, functional use, and operation of the lights and booms. The government has no particular requested format for this training. The contractor may use hand outs, demonstrations etc.

Advanced Training: Onsite training for Nursing Educator shall be provided to ensure they are training to be a trainer of the equipment.

Biomedical Training: Maintenance servicing of the equipment in accordance with manufacturer specifications and process for troubleshooting issues which may occur to the equipment during the warranty period. Biomedical training shall also include onsite or offsite training which will provide the Biomedical staff the ability to act as first responders in the event the equipment fails. If offsite training is available, the cost of tuition is to be included with the purchase of the equipment for one Biomedical Engineer.

6. Performance Monitoring The COR will monitor the successful delivery of the equipment by maintaining contact with the vendor and coordinating with the VA Warehouse and Biomedical Engineering personnel. The COR will also ensure the equipment is assembled and all installation of hardware and software is done in accordance with contract specifications.

7. Security Requirements The equipment and accessories will not connect to the VA network so there are no security requirements.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI)

There will be no Government-Furnished Equipment or Government furnished Information provided to the vendor.

9. Other Pertinent Information or Special Considerations

a. Identification of Possible Follow-on Work.

Possible follow-on work includes contact with the Vendor for troubleshooting or maintenance issues. Also, vendor may be notified if the product is not functioning properly.

b. Identification of Potential Conflicts of Interest (COI).

There are no known potential conflicts of interest.

c. Identification of Non-Disclosure Requirements.

The vendor will not have access to any VA patient sensitive information or proprietary information.

d. Packaging, Packing and Shipping Instructions.

Packaging and shipping will be at the discretion of the vendor.

e. Inspection and Acceptance Criteria.

Products will be inspected upon arrival by the COR and the facility Biomedical Engineering.

10. Risk Control The facility Biomedical Engineering will follow any safety recommendations given by the vendor for the equipment.

11. Place of Performance/Delivery Requirements Delivery shall be made Free on Board (FOB) destination. The equipment will be used in the designated ORs located within the facility:

Inspection: Destination Acceptance: Destination Free on Board (FOB): Destination Ship To and Mark For: Louis Stokes Cleveland VA Medical Center

12. Period of Performance Initial installation of two Hybrid rooms shall be complete within 90 calendar days of award along with one year warranty for each system. Delivery of seven operating rooms is anticipated to be within three months of contract award. These periods do not include the required 12 month warranty on each piece of equipment.

13. Delivery Schedule

· Task 1-The contractor shall provide the Louis Stokes Cleveland VA Medical Center a detailed specification and structural design sheet/drawing of their equipment within 10 calendar days of award notification for the two (2) Hybrid Suites.

· Task 2-The two (2) Hybrid Suites shall be delivered within 8 weeks after the approved specification and structural design sheet/drawing is received. Assembly and installation shall occur within 14 calendar days after delivery.

· Task 3- Standard OR Rooms 1-7 shall be delivered 8 weeks after installation of the two (2) Hybrid Suites. There is NO installation requirement for the seven (7) standard ORs.