SPECIAL NOTICE
J -- Service Contract for Spectranetics Laser System
- Notice Date
- 10/14/2021 2:23:28 PM
- Notice Type
- Special Notice
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24122Q0030
- Archive Date
- 11/13/2021
- Point of Contact
- Deborah L Reardon, Deborah.Reardon@va.gov, Phone: 410-691-1140
- E-Mail Address
-
deborah.reardon@va.gov
(deborah.reardon@va.gov)
- Awardee
- null
- Description
- Page 1 Pre-solicitation Notice of Intent to Sole Source Pre-Solicitation Notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract with: SPECTRANETICS CORPORATION, THE (151047370) 9965 FEDERAL DR COLORADO SPRINGS, CO 80921-3617 ueiSAM: VTD2KZWDP3L8 The purpose of this acquisition is to provide all labor, personnel, equipment, tools, materials, supervision, and other items necessary to perform the onsite and remote services and support as outlined in this statement of work. The Contractor shall provide onsite and remote service and support of both the CVX-300 Excimer Laser System. Serial Number 81093 The service required is for the period of performance: 12/01/2021 11/30/2022 Because Spectranetics LLC is the only vendor/contractor that can provide the service required, this acquisition will not be competed. Since the intent is to procure this on a sole source basis, no solicitation will be posted to Contracting Opportunities SAM.gov. The NAICS 811219. The size standard is 22 Million. The PSC/FSC is J065. This procurement is subject to prohibitions in VAAR 852.212-71 Gray Market Items and in 852.212-72 Gray Market and Counterfeit Items. VAAR 812.3 Solicitation Provisions and Contract Clauses This acquisition is subject to VAAR 852.212-73 Gray Market and Counterfeit Items Information Technology (IT) Maintenance Allowing-Other-than-New Parts. VAAR 812.3 Solicitation Provisions and Contract Clauses The authority for this action is FAR 6.302.1-1 Only one responsible source and no other supplies or services will satisfy agency requirements. Interested persons may contact the Contracting Officer/Contract Specialist by email at deborah.reardon@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer. Response must be received by 10/20/2021 2:00 PM EST. NEW ENGLAND HEALTHCARE SYSTEM VA BOSTON SERVICE CONTRACT STATEMENT OF WORK Period of Performance: 12/1/2021 11/30/2022 BASE+4 12/1/2022 - 11/30/2023 OPTION 1 12/1/2023 - 11/30/2024 OPTION 2 12/1/2024 - 11/30/2025 OPTION 3 12/1/2025 - 11/30/2026 OPTION 4 In order to provide full-service support and coverage needed for the Spectranetics Excimer Laser System Medical Equipment throughout the VA Boston Healthcare System. SCOPE: The systems to be covered and supported are at the following location. VA Boston HCS West Roxbury 1400 VFW Pkwy West Roxbury, MA 02132-4927 VA Boston HCS West Roxbury Systems to be covered: Spectranetics CVX-300 Excimer Laser Location: West Roxbury SN: 81093 Customer Number: 11334 Coverage Hours: Labor performed 8:00 am thru 5:00 pm, Monday through Friday local time at Equipment location, excluding holidays ( Business Hours ) Appendix A Requirements for Equipment These services and parts will be performed given the following criteria: Planned maintenance service (Regular PM inspection) Routine system calibration Remedial maintenance Quality assurance evaluations Replacement of parts (not including disposables & accessories) All equipment shall be maintained in proper operating condition as specified by the manufacturer. Vendor must have proven access to original equipment, manufacturers (OEM) parts manuals and schematics to perform the service. Vendors must provide their own EOM manuals and schematics, which must be available on site at time of service. All defective parts replaced become the property of the vendor. Parts and subsystems that need to be replaced containing PHI will be performed as follows: All media (e.g. hard drives) containing PHI will remain property of the VA. They will be removed from subsystem with Clinical Engineering Staff Member present and secured by Clinical Engineering Department. Clinical Engineering will identify media with equipment ID number for documentation. Clinical Engineering will transport Media to Field Ops for disposal. Vendor Personnel exposed to PHI will abide to signed BAA with the Department of Veterans Affairs Veterans Health Administration. Qualification of Vendor: Vendor will provide documentation of substantial experience working on the identified make and model instrument. This documentation shall specifically include individuals who will work on the systems. Contracting Officer reserves the right to request manufacturer specified training certificates from vendor personnel for servicing equipment under contract to determine qualification of responsibility. Labor and Travel Expenses: Vendor to provide labor and travel. All labor and travel conducted during normal FE coverage hours specified at each site. Preferred rates for labor and travel outside of coverage hours. Specifications of Work: Contractor will follow manufacturer s recommendations for PM, repair calibration and modifications, including use of diagnostic software where applicable. Replacement software will include all site-specific adaptation present in originally delivered software. Updates: Vendor will provide all software and hardware updates upon release at no additional cost to the Government throughout the life of this contract. Documentation Requirements: Service field reports shall be provided at the time of the service call and must be signed by contracting officer s COR and filed with the Biomedical Engineering department. Summary (or duplicate copies) of field service reports must be included with the invoices. Field service reports shall include written evidence of performance of all procedures and tests as required by the manufacturer. They shall include itemized parts and labor. Services and parts not covered by contract: Contracting Officer or Contracting Officer s COR authorization for any work or parts outside the scope of this contract must be received prior to performance of work or payment will not be authorized. Parts required that are not covered by contract will be purchased by the VA and installed under the terms of the contract. Safety Measures: Vendor will comply with all pertinent Federal Government/HIPAA/OSHA safety regulations, regarding to safeguarding patient information, during the handling of patient information containing hardware. Appendix B Requirements for VA Boston Unscheduled Maintenance (Emergency Repair Service): Contractor shall maintain the equipment in accordance with the manufacturer's specifications. 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 furnished. The COR or government designated representatives are authorized to request and approve service calls from the Contractor. Response Time: Contractor's FSE must respond with a phone call to the COR or designated representative within 1 hour after receipt of telephoned notification during normal hours of coverage. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within 4-8 hours after receipt of this notification and will proceed progressively to completion without undue delay. Scheduled Maintenance: The Contractor shall perform Preventive Maintenance (PM) Service to ensure that equipment performs in accordance with Conformance Standards. An outline of the PM procedures and schedule shall be provided to the COR or designated representative upon electronic request. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to COR or designated representative at the completion of the PM (preferably in electronic format). 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. At minimum, the contractor will perform electrical safety testing in accordance with NFPA standards. Frequency of preventive maintenance inspections will be contingent on the OEM recommendations as specified in their equipment service documentation. PM services shall include, but need not be limited to, the following: Cleaning of equipment. This includes vacuuming of filters, fans, and computer/electronic and mechanical assemblies as well as subsidiary equipment (i.e., Cardiac gates, monitors, etc.). Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Conformance Standards or the manufacturer's specifications. Calibrating and lubricating the equipment. Lubricants must conform to VAMC hazardous materials control and material data sheets made available. All calibrations, both electronic and mechanical must be as required by OEM specifications and guidelines. 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 which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance. Returning the equipment to the operating condition [defined in Conformance Standards]. Providing documentation of services performed. PM Services shall be performed in accordance with the Original Equipment Manufacture guidelines, and during the hours defined in the Hours of Coverage. All exceptions to the PM schedule shall be arranged and approved in advance with the COR or designated representative. Service is to be requested and coordinated only through the designated COR, so as to be assured that it is covered within the scope of the contract (work day 8-5 typical), and so that records are available for inspection by accrediting organizations. Any services not coordinated by the COR or designated representative will not be considered authorized and completed, and will be considered to fail to meet the terms of the contract. Parts: Any expenditures associated with shipment of parts will be the responsibility of the contractor. All parts, depending on availability, should be shipped as a priority, next day delivery. Service Manuals/Tools/Equipment: The VAMC 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 to its Facility Service Engineer s (FSE) 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. VAMC is authorized OEM cryptic access (Software key or Dongle) at no extra cost for the length of the contract. Diagnostic capability requires a minimum level two capability (OEM designation). Transportation Charges: All costs associated with transportation, from shipping point to the destination specified above, and all costs of removal after contract completion, shall be paid by the Contractor, and incorporated in the price proposal. The Contractor shall be responsible for all damage in transit including any transportation costs for replacement. Live Phone Support: Service shall include applications phone support with Canon Technical Support Engineers between 8am-5pm. VAMC will be responsible for maintaining proper network connection/tunnel for Canon RSN capability. Canon agrees to comply with all VAMC network regulations and compliance with VAMC security requirements. Authorization of network link will be approved by VAMC ISO. After Hours Phone Support: After hour phone support shall include 24 Hours, 7 Days a week and 365 days a year through Canon Customer Care Center when required. Documentation/Reports: The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with Conformance Standards or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The Engineering Service Report (ESR) will consist of a separate PM report for the item(s) covered under the ""specific"" contract. Grouping different equipment from different contracts on ""one"" ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail: Name of contractor and contract number. Name of FSE who performed services. Contractor service ESR number/log number. Date, time (starting and ending), equipment downtime and hours on-site for service call. VA purchase order number(s) covering the call if outside normal working hours. Description of problem reported by the COR or designated representative. Identification of equipment to be serviced: Inventory ID number, Manufacturer's name, Device name, Model number, Serial number, Any other manufacturer's identification numbers. Itemized Description of Service Performed (including, if applicable, costs associated with after normal working hour services) including: Labor and Travel, Parts (with part numbers), Materials and Circuit Location of problem/corrective action. Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage). Signatures: FSE performing services described. Authorized VA Employee who witnessed service described. Note: Any additional charges claimed must be approved by the COR or designated representative before service is completed. Reporting Requirements: The Contractor shall be required to report to the Clinical Engineering Department 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 designated representative. All ESRs shall be submitted to the equipment user for an ""acceptance signature"" and to the COR or designated representative for an ""authorization signature"". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the user. Failure to carry out the above required services shall constitute a failure to perform.
- Web Link
-
SAM.gov Permalink
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- Record
- SN06157440-F 20211016/211014230123 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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