SPECIAL NOTICE
J -- Heart/Lung Machine Contract Intent to Sole Source
- Notice Date
- 10/21/2022 10:33:40 AM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 252-NETWORK CONTRACT OFFICE 12 (36C252) MILWAUKEE WI 53214 USA
- ZIP Code
- 53214
- Solicitation Number
- 36C25223Q0117
- Archive Date
- 11/20/2022
- Point of Contact
- antaeus.gayles@va.gov, Antaeus Gayles, Phone: 414-844-480
- E-Mail Address
-
antaeus.gayles@va.gov
(antaeus.gayles@va.gov)
- Awardee
- null
- Description
- The Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) in North Chicago Il intends to negotiate a sole source contract with Spectrum Medical 481 Munn Road, Suite 180, Fort Mill SC 29715 for Preventive Maintenance, Emergency, and all Repair Services for ALL Spectrum Medical Extracorporeal Circulation & Perfusion (Heart-Lung Machine) equipment at Madison VA Hospital 2500 Overlook Terrace, Madison, WI 53705-2254. This contract will be for a firm fixed price contract. This procurement is being conducted in accordance with FAR 6.302-1, Only One Responsible Source and no other supplies or services will satisfy the agency requirements. The contract will be firm fixed price and the NAICS code is 339112 This Notice of Intent is not a request for competitive proposals. No solicitation documents are available and telephone requests will not be honored. However, if a firm believes it can meet the requirements it must furnish information about its products, services and capabilities as well as references from other customers who are using these products and services provide service Preventive Maintenance, Emergency, and all Repair Services for ALL Spectrum Medical Extracorporeal Circulation & Perfusion (Heart-Lung Machine) equipment at Madison VA 2500 Overlook Terrace, Madison, WI 53705-2254.to the contracting officer NLT 11:00AM CST, 27 October 2022. Supporting evidence must be submitted in sufficient detail to demonstrate the ability to comply with the above requirements and attached Statement of Work, to include access to OEM parts for repairs. Information must be sent to: Antaeus Gayles Great Lakes Acquisition Center Southern Tier 3001 Green Bay Road Building 1, Room 326 North Chicago, IL 60064-3048 Or via fax to (224) 610-3269, or via email response to antaeus.gayles@va.gov. Responses received will be evaluated; however a determination by the Government to not compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, the GLAC will proceed with the sole source negotiation with Spectrum Medical Statement of Work 2. Contract Title. Renewal 10-1-22 -> 9-30-23 Preventive Maintenance, Emergency, and all Repair Services for ALL Spectrum Medical Extracorporeal Circulation & Perfusion (Heart-Lung Machine) equipment at Madison VA Hospital. 3. Background. All Extracorporeal Circulation & Perfusion (Heart-Lung Machine) equipment owned by the Madison VA Hospital must operate at peak efficiency and per manufacturers design. Madison VA Hospitals Extracorporeal Circulation & Perfusion (Heart-Lung Machine) equipment require routine preventive maintenance as well as scheduled, unscheduled, and emergency repairs by manufacturers qualified service/repair technicians when required. 4. Scope. The contractor shall maintain and repair all Spectrum Medical Extracorporeal Circulation & Perfusion (Heart-Lung Machine) equipment in accordance with manufacturer s recommendations and standard commercial practices. The contractor shall be prepared to perform emergency maintenance services as required and shall respond within normal hours of coverage (8:00 am to 4:30 pm). 5. Specific Tasks. Vendor shall perform a minimum of ONE (1) PREVENTIVE MAINTENANCE (PM) INSPECTIONS on all Spectrum Medical Extracorporeal Circulation & Perfusion (Heart-Lung) equipment at a mutually agreed upon schedule. If more PM Inspections are required, vendor shall work with facility staff to coordinate schedule for each return visit. Each PM shall be in accordance with manufacturer's specifications. Each PM shall consist of complete cleaning, calibration, lubricating, adjustment, and replacement of ALL PARTS found to be defective to place this equipment in optimum operating condition. Contractor shall provide all labor required to replace all parts found to be defective due to normal wear and tear of this equipment. In addition, contractor shall provide ALL PARTS and SUPPLIES required for PM's and repairs unless otherwise noted. Equipment and components requiring service is listed as follows: Qty 2: Quantum Perfusion Technologies Systems, with major components notes as: QTY COMPONENT DESCRIPTION 2 Cheltenham Frames with Power Packs 2 QWS 15 (Quantum Work Station) 2 Quantum Console Module (5 rotary control knob) 2 Quantum Ventilation G2-DISS 8 Quantum Roller Pumps 6 2 Hand Crank Assy, 6 2 Quantum Centrifuge Drive CP37 1 Centrifugal Hand Crank CP37 12 Vertical Tube Clamps (Single & Triple) 4 Quantum Smart Occluders (LH & RH) 2 Level Sensors Assy 4 QFS Sensor 9/16 x 2.0m 2 QFS Sensor 11/16 x 2.0m 2 Hb-SO2 Twin 2.0 Sensor 9/16 List of Equipment covered Part Number Part Description Serial Number Lot Number Quantity 51-000021-00 Quantum Power Supply SR1001423 1.00 20-000391-00 Cord set C19 V-Lock 6m NEMA 5-15P US Clear 1.00 51-000025-01 QPF2 - Cheltenham MC2000162 1.00 51-000001-00 QWS 15"" PH1001364 1.00 51-000001-00 QWS 15"" PH1001909 1.00 43-000955-00 6"" Hand Crank Assembly 1.00 51-000003-00 Quantum Console Module (5 Rotary Knobs) AP1000950 1.00 51-000013-00 Quantum Roller Pump - 6"" AU6003002 1.00 51-000013-00 Quantum Roller Pump - 6"" AU6003003 1.00 51-000013-00 Quantum Roller Pump - 6"" AU6003004 1.00 51-000013-00 Quantum Roller Pump - 6"" AU6003007 1.00 51-000062-00 Quantum Centrifuge Drive - CP37 NP2000248 1.00 51-000062-00 Quantum Centrifuge Drive - CP37 NP2000249 1.00 52-000028-00 Centrifugal Hand Crank - CP37 1.00 51-000082-00 QVM2-D-HM - Quantum Ventilation Module ST1000555 1.00 43-000653-02 1.25 Vert. Tube Clamp - Single 5.00 43-000656-01 1.25 Vert. Tube Clamp - Triple 1.00 52-000009-00 Mounting Arm Kit 115mm 1.00 52-000023-00 Mounting Arm Assy Long 485mm - Hook Mounts x2 1.00 52-000041-00 Mounting Arm Assy Short 270mm - Hook Mounts x2 1.00 52-000060-00 G-Clamp to Hook Plate Adaptor Assy 1.00 52-000004-00 Tray Assy - 300x200x15mm 1.00 52-000013-00 Drip Stand Assy 2.00 52-000017-00 Ball & T-Bar Hex Driver Kit 1.00 51-000037-00 Hb-SO2 Twin 2.0m Sensor 9/16""(3/8 x 3/32) TR1000664 1.00 43-000889-00 Level Sensor Assy QLV1000232 1.00 51-000067-00 QFS 9/16 x 2.0m (ID 3/8"" x Wall 3/32"") FS4000238 2.00 51-000068-00 QFS 11/16 x 2.0m (ID 1/2"" x Wall 3/32"") FS5000134 1.00 51-000022-01 Quantum Smart Occluder - LH GL2000032 1.00 51-000074-01 Quantum Smart Occluder - RH GR2000042 1.00 44-000013-00-1200 Cable Assy White 1.20m - SAP Type 1 1.00 44-000014-00-0850 Cable Assy White 0.85m - SAP Type 3 2.00 44-000014-00-1000 Cable Assy White 1.00m - SAP Type 3 2.00 44-000039-00-1200 Cable Assy White 1.20m SAP Type 3-2 2.00 5.1 Task 1 Service Requirements 5.1.1 Subtask 1 Scheduled Maintenance. The contractor shall perform Preventative Maintenance (PM) service to ensure that equipment listed in the schedule performs in accordance with the manufacturer s specifications. The contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained provided to the COR, or designee, at the completion of the planned work. The contractor shall provide written description of Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following: Cleaning of equipment. Reviewing operating system software diagnostics to ensure that the system is operating to the manufacturer s specifications. Calibrating and lubricating the equipment. Performing remedial maintenance of non-emergent nature. Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn. Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying. Inspecting, and replacing where indicated, all mechanical components as needed. Returning the equipment to the operating condition defined in the manufacturer s specifications. Providing documentation of services performed. PM Services shall be performed in accordance with, and during the hours defined in, the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR, or designee. Any charges for parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and it s agreed upon price, unless specifically stated in writing otherwise. 5.1.2 Subtask 2 Unscheduled Maintenance (Emergency Repair Service). A. Contractor shall maintain the equipment in accordance with the manufacturer s specifications. The Contractor will provide repair service, including all required parts. B. The CO, COR or designated alternate has the authority to approve/request a service call from the Contractor. C. Response Time: Vendor MAXIMUM RESPONSE TIME for a Technician shall be within operating 24 hours. The MAXIMUM PHYSICAL RESPONSE TIME from the time the VA calls and requests vendor service on-site, until the vendor arrives on station ready to begin repairs, is 24 OPERATING HOURS. (e.g., since operating hours are from 8:00a.m. to 4:30 p.m. response, then a call to the maintenance contractor at 2:30 p.m. would require a physical response from the maintenance contractor no later than 2:30 p.m. the following work day). Emergency Repairs performed outside the normal hours of coverage, at the request of the COR, or designee, will be billed at the price listed in this contract. 5.1.3 Subtask 3 Documentation/Reports. The Equipment Service Report (ESR) documentation will include all detailed descriptions of the scheduled and unscheduled maintenance and procedures performed. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail: A. Name of contractor. B. Name of FSE who performed services. C. Contractor service ESR number/log number. D. Date, time (starting and ending), equipment downtime and hours on-site for service call. E. VA purchase order number(s) covering the call if outside normal working hours. F. Description of problem reported by COR, or designee/user (if applicable). G. Identification of equipment to be serviced, and Invoice ID number, manufacturer s name, device name, model number, serial number, and any other manufacturer s identification numbers. H. Itemized description of service performed (including costs associated with after normal working hour services) including labor and travel, parts (with part numbers) and Materials and circuit location of problem/corrective action. I. Total Cost to be billed (if applicable i.e., part(s) not covered, or service rendered after normal hours of coverage). J. Signatures: a. FSE performing service described b. VA Employee who witnessed service described Note: Any additional charges claimed must be approved by the COR before service is completed! 5.1.4 Subtask 4 Reporting Requirements. The Contractor shall be required to report to Biomedical Engineering to log in. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR, or designee. ALL ESRs shall be submitted to the equipment user for an ""acceptance signature"" and to the COR, or designee, for an ""authorization signature"". If the COR, or designee, is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR). PRIOR TO STARTING CONTRACT SERVICE, THE SERVICE REPRESENTATIVE SHALL REPORT TO Biomedical Engineering, Room C133. UPON COMPLETION OF REPAIRS, THE BADGE AND A COPY OF THE SIGNED PM AND EMERGENCY SERVICE DOCUMENTATION SHEETS SHALL BE RETURNED TO: Biomedical Engineering, Room C133. VA Biomedical Contact Person(s): Mark Heritage 5.2 Task 2 Support Requirements 5.2.1 Subtask 2.1 Software Updates The Contractor shall provide and install Software Updates on Quantum Perfusion Technologies modules on at least an ANNUAL basis, minimum once per year. 5.2.2 Subtask 2.2 Telephone Updates The Contractor shall provide telephone support for clinical applications support needs and technical support for troubleshooting needs during normal business hours. 5.2.3 Subtask 2.3 Extended Lifetime Warranty The Contractor shall provide an Extended Warranty for all Quantum Perfusion Modules including all sensors and cable assemblies for the 10-year expected life span of the equipment. Contractor shall replace products deemed beyond economical repair with the latest new build technologies available. 5.2.4 Subtask 2.4 Accidental Damage Coverage The Contractor shall include support with repair / replacement for components and/or modules which have become accidentally damaged. for the 10-year expected life span of the equipment. Contractor shall replace products deemed beyond economical repair with the latest new build technologies available. 5.2.5 Subtask 2.5 Remote Online Support The Contractor shall include support if desired with the Vision Server System and VPN access or equivalent as allowed by VA Network Security Policies. The Sentinel maintenance application shall be used to provide capability to support remote monitoring and fault diagnosis for all Quantum systems network connected to the local Vision server. 6. Performance Monitoring The Government is required to monitor contractor performance and certify the work was done in accordance with the contract. This monitoring will be done by the COR or their designee and performance criteria is as follows: Performance Objective Performance Threshold -Operational Up Time Requirements required by the -No more than 2 Customer VA Medical Center in accordance SOW. Complaints yearly. -Response Time will be made within the time -No more than 2 Customer Frames indicated. Complaints yearly. 7. Security Requirements Any clauses that are required will be determined by the ISO and Privacy Officer as provided in the VA Directive and Handbook 6500.6 Appendix A document that will address any security related issues. It is expected that vendor FSE shall not be exposed to PHI / ePHI during the course of maintaining the equipment. 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). Contractor shall provide ALL PARTS and SUPPLIES required for PM's and repairs unless otherwise noted. The Madison VA Hospital shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available all operational and technical documentation which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the Contracting Officer upon request. No GFE or GFI will be supplied to the Contractor. 9. Other Pertinent Information or Special Considerations. The Contractor shall furnish and replace parts to meet uptime requirements. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts but excluding operating supplies. The contractor shall use new or rebuilt parts. All parts shall be of current manufacturer and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts or those removed from another Heart-Lung machine shall not be installed without specific approval by the Contracting Officer, COR, or designee. 10. Risk Control There are no specific risks related to the performance of this contract. 11. Place of Performance. All work is to be performed on-site at the Madison VA Hospital located as 2500 Overlook Terrace, Madison, WI 53705-2254. 12. Period of Performance. The requested start date for this contract is October1-2022 and shall expire on September 30-2023. Madison VA also requests four additional option years that will extend from October 1, 2022, through September 30, 2026. Option years may be exercised at the discretion of the government.
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- Record
- SN06499957-F 20221023/221021230109 (samdaily.us)
- Source
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