Please note that this is NOT a request for quotes or proposals, the Government is seeking information for market research purposes only. VHA Reginal Procurement Office (RPO) 2 is currently conducting a market survey for qualified firms capable of providing service for Medtronic Stealth Station S7. The North American Industry Classification Systems (NAICS) is 811219. Responses to this notice must be submitted in writing (email or fax) and must be received no later than September 22, 2020 @ 10AM EST.
Email: LATEISHA.ROBINSON@VA.GOV and Fax: 718-741-4722. No telephone inquiries will be accepted.
Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, DUNS number and address, point of contact and social-economic.
Interested parties who do not submit the above information on or before the response due date and time will not be considered for this procurement.
Please review the attached Statement of Work attached herein.
STATEMENT OF WORK
Full Service Base + 4 option years contract for the period of 10/15/2020 through 10/14/2025 for the following government owned equipment.
A. Furnish all necessary labor, equipment, tools materials, repair service, software updates, parts, etc., for complete On-Site Maintenance Service as specified below in accordance with the terms, conditions and schedule of this agreement.
B. Contract Extension: The Government will have the Option to extend the Term of the contract for Four (4) additional years at the prices you bid. This is in accordance with the provision of FAR 52.217-9 in Section – I Contract Clauses of this Solicitation.
Equipment to be serviced/maintained includes:
MEDTRONIC STEALTH STATION S7 SURGICAL SYSTEM
INCLUDED AXIEM NAVIGATION
Location at Manhattan/Brooklyn VAMC:
SURGICAL OR SERVICE
A. Biomedical Engineering – Chief or designee, at:
Manhattan VAMC, 212-686-7500 ext. 7309
B. CO – Contracting Officer.
C. COR – Contracting Officer Representative.
D. 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 incidence of malfunction or inoperative conditions.
E. FSE – Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.
F. 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.
G. Acceptance Signature – VA employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR.
H. Authorization Signature – COR s signature; indicates COR accepts work status as stated in ESR.
I. NFPA – National Fire Protection Association.
J. CDRH – Center for Devices and Radiological Health.
K. VAMC – Department of Veterans Affairs Medical Center.
L. OSHA – Occupational Safety and Health Agency.
M. OEM – Original Equipment Manufacturer.
III. CONFORMANCE STANDARDS:
Contract service shall ensure that the equipment functions in conformance with the latest published editions of NFPA-99, OSHA, CDRH, and [include performance standards and specifications used when the Cat Scan System were procured by VA National, Acquisition Center and any upgrades/updates].
IV. HOURS OF COVERAGE:
A. Normal business hours of coverage are [Monday through Friday], [8:00am
– 4:30pm], excluding federal holidays. All service/repairs will be performed during the normal business hours of coverage unless requested and approved by the COR.
B. Preventive maintenance will be performed [monthly]. Preventive maintenance is to be performed inside normal business hours
C. Work performed inside the normal hours of coverage will include service time, and exclude parts and travel time as they are included in Section B, item I.
Note: Hardware/software scheduled and performed inside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by COR).
D. Federal Holidays observed by the
New Years Day Labor Day
Martin Luther King Day
President s Day
And any other day specifically declared by the President of the United States to be a national holiday.
A. Unlimited labor is included within the hours of coverage noted above.
A. The contractor shall maintain the equipment in accordance with the Conformance Standards Section, by furnishing all necessary labor, unlimited technical phone support, equipment, tools, materials, repair service, shipping charges and all peripherals.
Equipment repairs/service as specified in Section C, in Section C, I, Equipment, software updates and parts for service in accordance with the terms, conditions and schedule of this agreement. 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 calibrations.
B. Only, 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 phone call to the COR and his/her designee within [one (1) hour] after receipt of telephoned notification [24 hours per day]. If the problem can not be corrected by phone, the FSE will commence work (on-site physical response) within [four (4) hours] after receipt of notification or completion of phone support, and will proceed progressively to completion without undue delay. Except when outside hours of coverage is authorized by the COR.
D. Repair Up-Time: From the time when the FSE commences the on-site unscheduled maintenance, the repairs/service must be completed within are 24 hours (24 hours/day).
VI. SCHEDULED MAINTENANCE:
A. The contractor shall perform
Preventive Maintenance (PM) service to ensure that equipment listed in the schedule performs in accordance with Section C, III, Conformance Standards. The contractor shall make thorough technical inspections of the equipment covered in the Schedule. Within ten (10) days after the award of the contract, the contractor shall submit a schedule of PMs and a PM checklist describing in detail the scheduled maintenance procedures for inspecting each piece of equipment listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM. All equipment listed under Section C, I, Equipment, will have PM service performed annually.
PM services shall include, but need no be limited to, the following:
1. Cleaning of equipment.
2. Reviewing operating system software diagnostics to ensure that system is operating to the manufacturer s specifications.
3. Calibrating and lubricating the equipment.
4. Performing remedial maintenance of non-emergent nature.
5. Test and replacing faulty and worn parts and/or parts which are likely to become faulty, fail or become worn.
6. Adjusting and calibrating as necessary.
7. Inspecting electrical wiring and cables for wear and fraying.
8. Inspecting all mechanical components including, but not limited to patient restraints and support devices, chains, belts, bearing and tracks, interlocks, clutches, motors, mechanical integrity, safety, and performance.
9. Performing Electrical Safety Inspections, which should include line cord ground wire resistance and leakage as specified in the Conformance Standards.
10. Returning the equipment to the operating condition defined in Section
B. 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.
C. All parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise.
D. Upon completion of the preventive maintenance and electrical safety inspection, the FSE must tag the equipment with the appropriate labels used by each facility, if required by the facility. The FSE must fill-in label sections for: date inspection, date next due, and initials of FSE. Labels will be provided to the FSE when reporting (signing-in) to Biomedical Engineering.
The contractor shall furnish and replace parts to meet the repair up-time requirements as stated in Section C, V, Unscheduled Maintenance, D, Repair Up-time. If parts cannot be furnished by this time, the COR must be notified. The contractor has ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. New parts shall be furnished by the contractor and guaranteed against defects and/or failure for a period of 1 year from of completion installation of the component.
The contractor shall maintain all of the equipment listed in Section C, I, Equipments. In the event that an equipment needs service/repair, the contractor s FSE must respond with a phone call to the COR and his/her designee within [one(1) hour] after receipt of telephoned notification [24 hours per day]. If the problem can not be corrected by phone, the FSE will commence work (on-site physical response) to identify and help eliminate any problems, within [eight (8) hours] after receipt of notification or completion of phone support, and will proceed progressively to completion without undue delay.
IX. SERVICE MANUALS:
The VAMC shall not provide service manuals or service diagnostic software to the contractor. They 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 upon request.
The documentation will include legible detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour service) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards Section. In addition, each ESR must as 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 PO#(s) covering the call, if outside normal working hours.
F. Description of Problem Reported by COR/User.
G. Identification of Equipment to be serviced:
INV. ID#, Manufacturer s Name, Device Name, Model #, Serial #, and any other Manufacturers identification numbers.
H. Itemized Description of Service
Performed (including Cost associated with after normal working hour services), including:
Labor and Travel, Parts (with parts #) and Materials and Circuit Location of problem/corrective action.
I. Total Cost to be billed.
1. FSE performing services described.
2. A Employee who witnessed service described.
K. Equipment downtime
Note: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COR BEFORE SERVICE IS COMPLETED!
XI. REPORTING REQUIREMENTS:
A. The contractor shall be required to report to Biomedical Engineering and/or Surgical service to log in.
This check in is mandatory, and each facility will designate the appropriate area to report to. 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 and submit the ESR(s) to Biomedical Engineering and/or Surgical service. 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 COR by the contractor after the work can be reviewed (if requested or noted on the ESR).
B. The contractor is totally responsible for providing Service and Preventive Maintenance reports directly to the COR.
Purchase Order Payment Procedures:
Payments will be made monthly in arrears upon receipt of properly prepared invoices which must show reference to the correct purchase order number issued upon the award of this contract. Each invoice must be provided in [triplicate] and must include the Service Reports (ESR s) for work performed during that period.
B. Payment Procedures:
Invoices must then be mailed to the corresponding VAMC the charge is applied to. Each invoice must be provided in [triplicate] and must include the Service Reports (ESR s) for work performed. Invoices must show reference to the correct purchase order number and contract number issued upon the award of this contract. If there are any deductions to be made, or a credit card charge in was made in error, a credit will be due of the correct amount for the monthly payment in question. Notification of the credit, is to be made in writing for any adjustments that were made and then mailed to the corresponding VAMC.
XIII. ADDITIONAL CHARGES:
There will be no additional charge to the Government 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.
XIV. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:
The Contractor shall immediately, but not later than 24 consecutive hours after discovery notify the 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.
Offers will be considered only from offerors who are established in the business called for and whom in the judgment of the Contracting Officer (CO) are financially responsible and able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service.
All contractor employees and subcontractors under this contract or order are required to complete VA’s Information Security and Privacy combined Awareness Training Course annually.Ã‚Â Contractors must provide signed certifications of completion to the COR during each year of the contract.Ã‚Â This requirement is in addition to any other training that may be required of the contractor and subcontractor(s).
VA INFORMATION CUSTODIAL LANGUAGE
a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor’s rights to use data as described in Rights in Data – General, FAR 52.227-14(d) (1).
b. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.
c. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
d. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:
(1) Vendor must accept the system without the drive;
(2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or
(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.
(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;
(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and
(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.
(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; VA Handbook 6500.6, Contract Security APPENDIX C
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and
(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
XVI. CONDITION OF EQUIPMENT
The contractor accepts responsibility for the equipment described in Section C, 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.
XVII. COMPETENCY OF PERSONNEL SERVICES EQUIPMENT:
A. 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.
B. 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 comparable to that identified in the Section B schedule. For field experience, the FSE(s) has a minimum of three years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance, on equipment comparable to the Stealth Station Surgical System, identified in Section B schedule.
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 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 the COR specifically reserve the right to reject any of the contractor s personnel and refuse them permission to work on the VAMC equipment.
D. 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.
XVIII. TEST EQUIPMENT:
Prior to commencement of work on this contract, the contractor shall provide the VAMC with copy of current calibration shall perform and provided on an annual basis. Test equipment calibration shall be traceable to national standard.
XIX. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:
The contractor s FSE s shall wear visible identification at all times while on the premises of the VAMC. 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.
A. Worker compensation and employee s liability. Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.
B. 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.
C. Property Damage Liability.
Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.