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SAMDAILY.US - ISSUE OF JANUARY 14, 2022 SAM #7349
SPECIAL NOTICE

Z -- 521-22-2-125-0018 Heart Lung Svc Base + 4 (VA-22-00012521) Terumo Cardiovascular Systems Service

Notice Date
1/12/2022 11:28:24 AM
 
Notice Type
Special Notice
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
247-NETWORK CONTRACT OFFICE 7 (36C247) AUGUSTA GA 30904 USA
 
ZIP Code
30904
 
Solicitation Number
36C24722Q0266
 
Archive Date
01/27/2022
 
Point of Contact
Contract Specialist, EULANDA JAMES, Phone: 770 279 3444
 
E-Mail Address
Gracelyn.James@va.gov
(Gracelyn.James@va.gov)
 
Awardee
null
 
Description
Intend to Sole Source to - Terumo Cardiovascular Systems Corporation THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Department of Veterans Affairs, Birmingham VA Medical Center intends to award a firm fixed price sole source contract under the authority of 41 U.S.C. 253(c)(1) and FAR 13.106-1(b)(1)(i), only one source to: Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 The objective of this sole source award is to acquire an annual preventive maintenance and any subsequent repairs for Terumo Cardiovascular Systems. Sole source is based on only one responsible source as Terumo Cardiovascular Systems Corporation is the manufacturer of Terumo Cardiovascular Systems. The proprietary letter provided by Terumo Cardiovascular Systems Corporation is part of the contract file. The NAICS Code for this requirement is 339112; the small business size standard is 1,000 employees. This notice of intent is not a request for competitive quotes; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. All information received by 10:00AM EST on January 20, 2022 may be considered by the Government. Responses shall be submitted to Eulanda James, Contract Specialist at Gracelyn.James@va.gov. The email subject line shall state, Birmingham VA Medical Center , Intent to Sole Source to Terumo Cardiovascular Systems Corporation . A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. STATEMENT OF WORK Equipment The intent of this solicitation is to provide full-service maintenance and repair services for two (2) Terumo Advanced perfusion System 1 Units, twelve (12) Perfusion Accessory Roller Pumps, and two (2) CDI 550 Units located in the Operating Rooms at the Department of Veterans Affairs Medical Center, 700 South 19th Street, Birmingham, AL 35233. Contract shall include four (4) one year option renewals and in accordance with the terms, conditions, special provisions, and schedules herein. Period of Performance: Base 2/1/2021 1/31/2022 Option 1 2/1/2022 1/31/2023 Option 2 2/1/2023 1/31/2024 Option 3 2/1/2024 1/31/2025 Option 4 2/1/2025 1/31/2026 Heart Lung Machine 100/120v AC APS Platform, Asset: MX 2048421, SN: S1783 Heart Lung Machine 100/120v AC APS Platform, Asset: MX 2048422, SN: S1784 Perfusion Accessory Roller Pump for System 1, Asset: MX 1482494, SN: 6252 Perfusion Accessory Roller Pump for System 1, Asset: MX 1522241, SN: 6251 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048416, SN: 8245 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048411, SN: 8385 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048413, SN: 8383 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048415, SN: 8246 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048409, SN: 8373 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048412, SN: 8247 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048407, SN: 8370 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048408, SN: 8372 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048410, SN: 8386 Perfusion Accessory Roller Pump for System 1, Asset: MX 2048414, SN: 8384 Terumo Blood Parameter Monitory System, CDI 550, Asset: MX2059124, SN:1435 Terumo Blood Parameter Monitory System, CDI 550, Asset: MX2059130, SN:1425 Unscheduled Maintenance A. The contractor shall maintain the equipment in accordance with B.1.3, Conformance Standards. The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be original equipment manufacturer (OEM) parts and be furnished by the contractor. B. The CO, COR or designated alternate has the authority to approve/request a service call from the contractor. C. Response Time: Contractor's FSE must respond with a telephone call to the COR and his/her designee within 30 minutes after receipt of telephoned notification 24 hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within four (4) hours after receipt of notification and will proceed progressively to completion without undue delay. For example, if hours of coverage are 8:00 a.m. to 5:00 p.m., a 4-hour response means, if a call is placed at 3:45 p.m. Monday, August 10, the FSE must start on-site service before 10:45 a.m. Tuesday, August 11, except when outside hours of coverage is authorized by the COR. Scheduled Maintenance A. The contractor shall perform PM Service to ensure that equipment listed in the schedule performs in accordance with Section B.1.3, Conformance Standards. The contractor shall provide and utilize OEM approved, and up-to-date procedures and checklists, with worksheet originals indicating work performed and actual values obtained (as applicable) and shall provide said documentation to the COR at the completion of the PM. PM services shall include, but may not be limited to, the following: 1) Cleaning of equipment. 2) Reviewing operating system software diagnostics to ensure that the system is operating to the manufacturer's specifications with access to all proprietary service keys necessary to perform this function 3) Calibrating and lubricating the equipment. 4) Performing remedial maintenance of non-emergent nature. 5) Testing and replacing faulty and worn parts and/or parts which are likely to become faulty, fail or become worn. 6) Inspecting, and replacing where indicated, tubing for wear and fraying. 7) Measuring, adjusting and calibrating as necessary. 8) Inspecting, and replacing where indicated, electrical wiring and cables for wear and fraying, 9) Inspecting and replacing where indicated, all mechanical components including, for mechanical integrity, safety, and performance. 10) Image quality assessment. 11) Apply gummed label, dated & signed, certifying performance and safety to meet manufacturer published specifications as of that date. 12) Returning the equipment to the operating condition defined in Section B.1.3, Conformance Standards. 13) Providing documentation (worksheet) of services performed on each machine tested. 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. 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. B. The contractor shall furnish documentation, including all measurements and calibration data. C. The contractor shall furnish all backup documentation to ensure that the system is performing in accordance with Section B.1.3, Conformance Standards. Parts The contractor shall furnish and replace parts to meet up-time requirements (consumables are not covered). The contractor has available inventory of OEM parts on hand to support the equipment covered under this agreement. All parts supplied shall be OEM parts and compatible with existing equipment. The contract shall include all parts and software. The contractor shall use new parts. Re-built parts or used parts, those removed from other equipment, shall not be installed without approval by the COR. Service Manuals The DVAMC shall not provide OEM service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as operational and service manuals, schematics, and parts list), 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 CO or COR upon request. Documentation/Reports The documentation will include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in Section B.1.3, Conformance Standards. In addition, each ESR shall, 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), and Hours-On-Site for service call. E. Description of Problem Reported by COR/User. F. Identification of Equipment to be serviced: Inventory ID number, Manufacturer's name, Device Name, Model number, Serial number, and any other Manufacturer's identification numbers. G. Itemized description of service performed, including labor and travel, parts (with part numbers), materials and circuit location of problem/corrective action. H. Total Cost to be billed. I. Signatures: 1. FSE performing services described. 2. VA Employee who witnessed service described may initial said ESR, but only the COR has the authority to sign the ESR J. Equipment downtime. K. VA Purchase Order Number. NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COR BEFORE SERVICE IS COMPLETED. Reporting Requirements The contractor shall be required to report to the Biomedical Engineering supervisor or designee. 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 the Biomedical Section Manager or designee, and submit the ESR (s) to the COR. All ESRs shall be submitted to the equipment user for an ""acceptance signature"" and to the COR for an ""authorization signature"". If the COR is unavailable a signed, authorized, copy of the ESR will be sent to the contractor after the work can be reviewed (if request or noted on the ESR). Additional Charges There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts. Reporting Required Services Beyond the Contract Scope The Contractor shall immediately, but not later than 24 consecutive hours after discovery notify the CO and COR, in writing, of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs. Condition of Equipment The contractor accepts responsibility for the equipment described in the schedule ""as is"" condition. Failure to inspect the equipment prior to contract award shall not relieve the contractor from performance of the requirements of this contract. Competency of Personnel Servicing Equipment A. Each respondent shall have an established business, with an office and full-time staff. The staff includes a ""fully qualified"" FSE and a ""fully qualified"" FSE who will serve as the backup. B. ""Fully Qualified"" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized manufacturer training programs within the last two years, for the equipment identified in the equipment schedule, and annual refresher course. For field experience, the FSE(s) has a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance, on equipment listed. C. The FSEs shall be authorized by the contractor to perform the maintenance services. All work shall be performed by ""Fully Qualified"" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the DVAMC. The CO may authenticate the training requirements, request training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any DVAMC equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the DVAMC equipment. D. Subcontractor will not be used under this contract unless authorized and approved by the COR. Test Equipment Prior to commencement of work on this contract, the contractor shall provide the DVAMC with a copy of the current calibration certification of all test equipment which is to be used by the contractor on DVAMC's equipment. This certification shall also be provided on a periodic basis when requested by the DVAMC. Test equipment calibration shall be traceable to a national standard.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/598c5112814b4704b643ba88808b5269/view)
 
Record
SN06215546-F 20220114/220112230103 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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