J065--Service support for AlignRT systems

Under Statutory Authority 41 U.S.C. 1901, the Great Lakes Acquisition Center (GLAC) intends to negotiate a sole source contract with Align Rt Inc. for service on the Surface Guided Radiation Therapy Patient Positioning Equipment located at the Clement J. Zablocki VA Medical Center, Milwaukee, WI. Vision Rt, Inc., is the only. vendor capable of providing service and parts. This procurement is being conducted in accordance with FAR 12 & 13 Single Source Award Justification for Simplified Acquisitions Procedure and no other vendor will satisfy agency requirements.

This acquisition is conducted under the authority of 41 U.S.C. 1901 Simplified acquisition procedures as implemented in FAR 13.106-3(b)(3)(i), only one responsible source and no other supplies or services will satisfy agency requirements. This will be a firm fixed price contract for one 12-month base year contract with four option year renewal periods to be exercised at the discretion of the government. The NAICS Code is 811210.

This notice of intent is not a request for competitive quotes. No solicitation documents are available and telephone requests will not be accepted. However, any firm that believes it can meet these requirements may give written notification to the Contracting Officer by 9:00 AM (local time) September 27, 2024. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirements. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, the Contracting Office will proceed with the sole source negotiation with Cooper Atkins Corporation.

Information must be sent to the Contracting Officer, Lori.Eastmead@va.gov. TELEPHONE INQUIRIES WILL NOT BE ACCEPTED.

Statement of Work for Maintenance Service

on Surface Guided Radiation Therapy Patient Positioning Equipment

SCOPE OF WORK:

Provide labor, travel, time, spare parts, materials, tools, and equipment to service Vision RT high tech medical equipment, including scheduled and unscheduled maintenance, located at the Clement J. Zablocki VA Medical Center, (VAMC) 5000 W. National Avenue, Milwaukee, WI 53295.

EQUIPMENT IDENTIFICATION (also see Attachment A)

DESCRIPTION: PCR# 249-2639 Align RT w/SRS Workstation and Cameras

MANUFACTURER:Â Vision RT

MODEL: Align RT Advance

Serial No.:249-2639

Location: Milwaukee VAMC, Radiation Oncology

DESCRIPTION: Align RT Offline workstation - PCR# 300-0383

MANUFACTURER:Â Vision RT

MODEL: Align RT Offline workstation

Serial No.: 300-0383

Location: Milwaukee VAMC, Radiation Oncology

DEFINITIONS/ACRONYMS:

CO - Contracting Officer

COR - Contracting Officer's Representative

PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

CONFORMANCE STANDARDS:

Contract service shall ensure that the equipment functions in conformance with the latest published edition of National Fire Protection Association (NFPA), Underwriters Laboratory (UL), Occupational Safety and Health Administration (OSHA), Food and Drug Administration, Center for Devices and Radiological Health (FDA-CDRH), Joint Commission and VA standards.

Contract service shall also ensure that the equipment performance/specifications are equal to or exceed the performance/specifications when the equipment was originally accepted after procurement.

All upgrades/updates shall also be included in this contract except for upgrades that provide new features or capabilities or that require hardware changes.

HOURS OF COVERAGE:

Normal hours of coverage are Monday through Friday from 8:00 AM to 7:00 PM Local Time, excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or designee.

Preventive maintenance will be performed to ensure equipment performs with Conformance Standards.

Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.

Hardware/software update/upgrade installations will be scheduled and performed at a mutually agreeable time.

Holidays, or any other day specifically declared by the President of the United States to be a Federal Holiday include:

New Years' Day Labor Day

Martin Luther King, Jr. Day Columbus Day

Presidents Day Veterans Day

Memorial Day Thanksgiving Day

Juneteenth Christmas Day

Independence Day

UNSCHEDULED MAINTENANCE (Emergency Repair Service)

Contractor shall maintain the equipment in accordance with the Conformance Standards. The Contractor will 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.

The Contractor shall also provide unlimited telephone and on-line support for applications software and systems engineering questions during the times specified in paragraph 5, HOURS OF COVERAGE.

The CO, COR or designated alternate has the authority to approve/request a service call from the Contractor.

Response Time: Contractor shall accept and log service and support requests via telephone 24 hours per day. Contractor's FSE must respond to telephoned notifications with a phone call to the COR or his/her designee within the next 1 hour of normal business hours specified in paragraph 5, HOURS OF COVERAGE. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) by the next business day. Next day on-site support response to incidents reported to contractor after 2 PM local time will be on a best effort basis, no later than two business day on-site physical response.

SCHEDULED MAINTENANCE

The Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with the Conformance Standards. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM. 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:

1. Cleaning of equipment.

2. Reviewing operating system software diagnostics to ensure that the system is operating to the manufacturer's specifications.

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 likely to become faulty, fail or become worn.

6. Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

7. 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.

8. Returning the equipment to the operating condition defined in Section C, III, Conformance Standards.

9. Providing documentation of services performed.

10. Installation of software updates or upgrades necessary to maintain proper operation of the system in accordance with Section III.

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.

PARTS

The Contractor shall furnish and replace parts to meet requirements in paragraph 4, Conformance Standards. 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 contractor shall use new or rebuilt parts. All parts shall be of current manufacture 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 system, shall not be installed without specific approval by the CO or the COR.

Parts shall be available for delivery next business day if ordered by 2:00 PM local time.

CLINICAL APPLICATIONS SUPPORT AND PORTAL

Contractor shall provide 1 (one) clinical applications support site-visit lasting up to 2 (two) days, or 1 (one) seat at a P-1 training course each contract period.

Contractor shall coordinate, with Milwaukee VAMC Radiation Oncology clinicians, two clinical applications follow-up question-and-answer sessions per contract year.

Contractor shall provide access to the My Vision RT online Support Portal.

SOFTWARE MAINTENANCE AND REMOTE SERVICE

The Contractor shall provide all software updates to maintain the systems in accordance with Conformance Standards. This shall include all operating system patches and virus protection updates.

Contractor shall provide remote support through an approved National Site to Site VPN with VA Field Security Service, Health Information Security Division.

SERVICE MANUALS, TOOLS, AND TEST 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 FSE's all operational and technical documentation (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 upon request.

DOCUMENTATION/REPORTS:

The documentation will 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 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 COR/user (If applicable).

Identification of equipment to be serviced:

Inv. Id number, manufacturer's name, device name, model number, serial number, and 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) and 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.

VA Employee who witnessed service described.

NOTE: Any additional charges claimed must be approved by the COR before service is completed.

FOOTNOTE: The contractor may design/develop an ESR report form that incorporates the above MINIMUM criteria. The form should be on standard 8 1/2 x 11 paper and MUST BE APPROVED BY the CO or COR prior to use and implementation.

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. 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 requested or noted on the ESR).

VA Biomedical Contact Person(s): COR

Location (Building/Room Number): VA Milwaukee, 70C9

Telephone Number & Extension(s): 414-384-2000 x 41070.

Contractor -- Provide telephone number(s) to call for your Service Department: ____________________________________

Provide name(s) of authorized contact person(s):_________________

_________________________________________________________________

PAYMENT:

Invoices will be paid monthly in arrears. Invoices, MUST INCLUDE, at a minimum, the following information: Contract no., Purchase Order No., Item(s) covered (to include serial #'s) by the PMI and covered period of service.

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 no later than 24 (twenty-four) 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 Section C, paragraph I., in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

Each respondent must 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.

"Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in the Section B schedule. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on the digital radiography system.

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 VAMC. 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 VAMC equipment. The CO and/or COR specifically reserves the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment.

If subcontractor(s) are used, they must be approved by the CO; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

TEST EQUIPMENT:

Upon request, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.

IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

The Contractor's FSEs shall wear visible identification while on the premises of the VAMC. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

INSURANCE:

Worker compensation and employer's liability. Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.

General Liability. Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

Property Damage Liability. Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.