Medrad PWS Draft.rtf
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Department of Veterans Affairs
About this file
This Performance Work Statement (PWS) details full service and maintenance requirements for Medrad Dye Injectors at six Veterans Affairs (VA) Medical Centers within VISN 4, located in Pennsylvania and Delaware. The contract is a firm-fixed-price, three-year base period covering multiple medical imaging injection systems including MRXperion MR, Stellant CT, Mark 7 Arterion Angiography, and Mark V ProVis Angiography Injection Systems across facilities in Altoona, Coatesville, Erie, Lebanon, Pittsburgh, and Wilkes-Barre.
Key performance requirements include a 97% equipment uptime guarantee, preventive and corrective maintenance, remote support within 1 hour, on-site service within 4 hours, and full equipment resolution within 48 hours. The contractor must provide original manufacturer parts, software updates, and have field service engineers with at least two years of experience and formal equipment training. Services will be performed during normal business hours (8am-5pm, Monday-Friday), with 24/7 customer service availability, and all maintenance documentation must be comprehensively recorded and submitted to VA biomedical engineering staff.
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Performance Work Statement (PWS)
GENERAL GUIDANCE
Title: Full Service and Maintenance of Veterans Integrated Service Network (VISN) 4 Veterans Administration (VA) Medical Facility owned Medrad Dye Injectors Scope of Work: The contractor shall provide full service and maintenance for government owned Medrad Dye Injectors required by the requirements stated herein. The facilities are located at:
Altoona James E. Van Zandt Veterans Affairs Medical Center 2907 Pleasant Valley Boulevard Altoona, PA 16602
BLAIR COUNTY
Coatesville Coatesville Veterans Affairs Medical Center 1400 Black Horse Hill Road Coatesville, PA 19320
CHESTER COUNTY
Erie Erie Veterans Affairs Medical Center 135 East 38th Street Erie, PA 16504
ERIE COUNTY
Lebanon Lebanon Veterans Affairs Medical Center 1700 S. Lincoln Avenue Lebaonon, PA 17042
LEBANON COUNTY
Pittsburgh Veterans Affairs Pittsburgh Healthcare System
| University Drive Campus | and | H. J. Heinz Campus | |
| University Drive C | 1010 Delafield Road | ||
| Pittsburgh, PA 15240 | Pittsburgh, PA 15215 |
ALLEGHENY COUNTY
Wilkes-Barre Wilkes-Barre Veterans Affairs Medical Center 1111 East End Boulevard Wilkes-Barre, PA 18711
LUZERNE COUNTY
| Background: This contract is issued to ensure the continuous reliability of the Medrad Dye Injectors identified in this PWS. The units require repair and maintenance by trained personnel using manufacturer approved parts and specifications. These units are critical for delivering contrast to patients for the Diagnostic Imaging Department at the VISN 4 VA Medical Facilities listed. The reliable and accurate operation of this equipment at all times is considered critical to the health of patients. |
| Performance period: 3-year base |
| Type of Contract: Firm-fixed-price. |
GENERAL REQUIREMENTS
This agreement includes all preventative maintenance and corrective maintenance repairs for the Medrad Dye Injectors for continuous reliability.
| Equipment to be Serviced: |
| Each of the following items are to be serviced in accordance with the specifications, terms and conditions of this contract. |
CLIN
Description/Part Number* Part # Qty Altoona VAMC Maintenance & Repair
0001A MRXperion MR Injection System SN 300487
0001B Stellant D CT Injection System SN 300309
Coatesville VAMC Maintenance & Repair
0002A MRXperion MR Injection System SN 313523
0002B Stellant D CT Injection System SN 28926
Erie VAMC Maintenance & Repair
0003A Stellant Flex CT Injection System SN 100207
0003B Stellant Flex CT Injection System SN 100422
Lebanon VAMC Maintenance & Repair
0004A MRXperion MR Injection System
Pittsburgh VAMC Maintenance & Service
0005A Mark 7 Arterion Agiography Injection System 202598
0005B Mark 7 Arterion Agiography Injection System 300029
0005C Mark 7 Arterion Agiography Injection System 203269
0005D Mark 7 Arterion Agiography Injection System 202693
0005E Mark 7 Arterion Agiography Injection System 20168
0005F Stellant Flex CT Injection System SN 120623
0005G Stellant Flex CT Injection System SN 120167
0005H Stellant Flex CT Injection System SN 121135
0005J Stellant Flex CT Injection System SN 121149
0005K MRXperion MR Injection System SN 311387
0005L MRXperion MR Injection System SN 300229
0005M MRXperion MR Injection System SN 300034
0005N Stellant Sx CT Injection System SN 200313
0005P Mark V ProVis Angiography Injection System SN 200989 (POP ends 12/31/25) 0005Q Mark V ProVis Angiography Injection System SN 103780 (POP ends 12/31/25) Wilkes Barre Maintenance & Service
0006A Mark 7 Arterion Angiography Injection System SN 100790
0006B Mark 7 Arterion Angiography Injection System SN 310480
0006C Stellant Flex CT Injection System SN 120130
0006D Stellant Flex CT Injection System SN 120123
0006E Stellant Flex CT Injection System SN 120007
0006F Stellant Flex CT Injection System SN 120301
0006G MRXperion MR Injection System SN 300290
1001A
1001B Stellant D CT Injection System SN 300309
1002A
1002B Stellant D CT Injection System SN 28926
1003A
1003B Stellant Flex CT Injection System SN 100422
1004A MRXperion MR Injection System SN 301538
1005A
1005B Mark 7 Arterion Agiography Injection System 300029
1005C Mark 7 Arterion Agiography Injection System 203269
1005D Mark 7 Arterion Agiography Injection System 202693
1005E Mark 7 Arterion Agiography Injection System 20168
1005F Stellant Flex CT Injection System SN 120623
1005G Stellant Flex CT Injection System SN 120167
1005H Stellant Flex CT Injection System SN 121135
1005J Stellant Flex CT Injection System SN 121149
1005K MRXperion MR Injection System SN 311387
1005L MRXperion MR Injection System SN 300229
1005M MRXperion MR Injection System SN 300034
1005N Stellant Sx CT Injection System SN 200313
1006A
1006B Mark 7 Arterion Angiography Injection System SN 310480
1006C Stellant Flex CT Injection System SN 120130
1006D Stellant Flex CT Injection System SN 120123
1006E Stellant Flex CT Injection System SN 120007
1006F Stellant Flex CT Injection System SN 120301
1006G MRXperion MR Injection System SN 300290
2001A
2001B Stellant D CT Injection System SN 300309
2002A
2002B Stellant D CT Injection System SN 28926
2003A
2003B Stellant Flex CT Injection System SN 100422
2004A MRXperion MR Injection System
2005A
2005B Mark 7 Arterion Agiography Injection System 300029
2005C Mark 7 Arterion Agiography Injection System 203269
2005D Mark 7 Arterion Agiography Injection System 202693
2005E Mark 7 Arterion Agiography Injection System 20168
2005F Stellant Flex CT Injection System SN 120623
2005G Stellant Flex CT Injection System SN 120167
2005H Stellant Flex CT Injection System SN 121135
2005J Stellant Flex CT Injection System SN 121149
2005K MRXperion MR Injection System SN 311387
2005L MRXperion MR Injection System SN 300229
2005M MRXperion MR Injection System SN 300034
2005N Stellant Sx CT Injection System SN 200313
2006A
2006B Mark 7 Arterion Angiography Injection System SN 310480
2006C Stellant Flex CT Injection System SN 120130
2006D Stellant Flex CT Injection System SN 120123
2006E Stellant Flex CT Injection System SN 120007
2006F Stellant Flex CT Injection System SN 120301
2006G MRXperion MR Injection System SN 300290
| Corrective Maintenance: |
| The Contractor and Biomedical Engineering shall maintain the equipment in accordance with Section C Conformance Standards. Service for corrective maintenance will be provided per hours of coverage defined in Section B.1g. Contractor shall provide unlimited telephone technical support, labor, travel, and parts, unless specifically excluded. |
| Service calls to the Contractor requesting service are only authorized when they are received from the Contracting Officer Representative (COR), Contracting Officer (CO), or designated alternates. |
| Outside of the Contract’s hours of coverage, emergency on-site services require authorization by the CO. The CO or a Biomedical Engineering Staff Member shall initiate these calls. If VA staff other than the CO or a Biomedical Engineering Staff Member place calls requesting services, the Contractor shall contact Biomedical Engineering services and verify the request. Service responses on calls from unauthorized personnel can result in nonpayment. |
| Uncorrected deficiencies or unfavorable histories of downtime can result in the termination of this contract under the Termination for Default clauses of the Federal Acquisition Regulations. |
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 operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturers National Fire Protection Association (NFPA) NFPA-99, JC, NEC, OSHA, HIPAA, Federal and VA VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.
| The Contractor shall perform preventative maintenance (PM) service to ensure that equipment listed in Section B.1a performs in accordance with Section C Conformance Standards. Any exceptions to the PM schedule shall be arranged and approved in advance with the COR and provided in writing to the CO. |
| The Contractor shall provide complete and original documentation indicating PM work performed, referencing the procedures followed, actual tests and/or evaluation results obtained to the COR at the completion of the PM service. |
| Additionally, PM services include a complete verification and recalibration per factory specifications. |
| Parts, travel, and labor necessary for PM are provided by awarded contractor at no additional customer cost. |
| Any charges for materials such as lubricants, fluids, cleaning supplies, services, manuals, or tools required for the Contractor to successfully complete scheduled PM shall be provided by the Contractor and are included within this contract, and it’s agreed upon price. |
| Preventative maintenance will be provided at a scheduled time and must be scheduled at least one week in advance to minimize the impact to patient scheduling. All exceptions to the preventative maintenance schedule and procedure shall be addressed and approved in advanced with the COR. A designated staff member will accompany the Contractor as an observer during the inspection. The inspection shall be thorough and shall conform to manufacturer and Industry Standards for the equipment. Sufficient time shall be allowed to permit a thorough inspection and test of each device comprising the overall system. Maintenance work and inspections may be combined at the approval of the COR or alternate COR if downtime is not considered significant. |
| The Contractor shall immediately, but no 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. |
| Parts and Software |
| The contract shall include all parts except for consumable or expendable items. All parts supplied shall be Original Equipment Manufacturer (OEM) and fully compatible with existing equipment. Used parts (or refurbished), those removed from another system, shall not be installed without approval by the COR. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible. The determination of compatibility is at the discretion of the COR. All defective parts replaced become the property of the Contractor, unless otherwise specified by the CO, COR, or Alt COR. |
| Any software patches, software updates and quality updates are included under the terms of this contract and shall be applied in accordance with manufacturer specifications. |
| Upon release from the OEM, software updates must be provided for equipment no later than one month upon notification of release. |
| Remote Service |
| The contractor must be able to provide remote support as needed by phone for the equipment listed in this contract. |
| Personnel with OEM equipment training will respond by phone within 1 hour of the call for service. If situations are responded to by phone and do not resolve the service issue, OEM trained personnel will be required for an on-site visit within 4 hours after receipt of initial notification unless otherwise agreed upon, in writing, by the COR or Biomedical Engineering personnel. Full resolution is expected within 48 hours of initial call. If the contractor cannot remediate the issues within this timeframe, the COR or Alt COR shall be notified immediately and provided an estimated time for resolution. |
| System Uptime: |
| The contractor must guarantee a 97% uptime guarantee for each piece of equipment outline in B.1a over each 12-month contract period. |
| Downtime will be calculated from the time a call is placed to the contractor to the time of repair completion and the system can be fully used. Uptime between |
8am-5pm, Monday-Friday will be considered towards the overall uptime percentage for the contract.
| Hours of Coverage: |
| The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (EST) M-F), excluding holidays. |
| All services shall be performed during these normal hours of coverage unless one of the following conditions exists: |
| The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to the COR prior to the proposed start of the |
work, and the request is approved in writing by the COR before work is begun.
| The COR directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended by the COR and authorized by the CO. |
| Customer service shall respond to service request calls 24 hours a day, 7 days a week and all holidays. |
| Work performed outside the normal hours of coverage must be preapproved by the CO, COR or Alt COR. The Contractor will provide a written estimate of the charges prior to approval of the work. |
| Work performed outside the normal hours of coverage at the request of the Field Service Engineer (FSE)/contractor shall be considered service performed during normal hours of coverage. |
| There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts. |
Note: Any hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government.
Federal Holidays Observed by the VA Medical Center New Year’s Day, Martin Luther King, Jr. Day, President’s Day (Washington’s birthday), Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States.
| Customer Notification: |
| Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all preventative maintenance with Biomedical Engineering. |
| When the service(s) is/are completed, the FSE shall document the services rendered on a legible Vendor Engineering Service Report (ESR(s)) per Section E. |
| The FSE shall be required to check out with the Biomedical Engineering Department 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 accepted copy of the ESR will be sent to the COR within five business days of work completion. |
IV. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT.
CONFORMANCE STANDARDS:
Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of National Fire Protection Association (NFPA) NFPA-99, Joint Commission (JC), National Electric Code (NEC), Occupational Safety and Health Administration (OSHA), Health Insurance Portability and Accountability Act (HIPAA), Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the current performance specifications as established in the OEM’s technical specifications. If acquisition of required replacement parts becomes unattainable to meet current equipment performance specifications and a solution exists to upgrade the equipment, the Contractor is required to proceed with the upgrade at no additional cost to the VA, unless otherwise agreed upon in writing by the VA.
DOCUMENTATION/REPORTS:
The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail:
| Name of Contractor |
| Name of FSE who performed services. |
| Contractor Service ESR Number/Log Number. |
| Date, Time (starting and ending), Hours-On-Site for service call. |
| VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours. |
| Description of Problem Reported by COR/User. |
Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other manufacturer's identification numbers.
| Itemized Description of Service(s) 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. |
| Total Cost to be billed. |
| Signatures from the following: |
| FSE performing services described. |
VA Employee who witnessed service described.
Equipment downtime calculated in accordance with Conformance Standards.
Note: Any additional charges claimed must be approved by the COR before service is started.
SCHEDULE FOR DELIVERABLES
Draft copies of deliverables shall be provided to Biomedical Engineering staff at VISN 4 VA Medical Facilities before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable.
CHANGES TO Performance Work Statement
Any changes to this PWS shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project.
Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.
SERVICE MANUALS/TOOLS/EQUIPMENT
VISN 4 VA Medical Facilities shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. 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 upon request.
Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by VISN 4 VA Medical Facilities. Test equipment calibration shall be traceable to a national standard.
CONDITION OF EQUIPMENT:
The contractor accepts responsibility for the equipment described in this scope of work, 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.
CONTRACTOR EXPERIENCE REQUIREMENTS
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) shall have successfully completed a formalized training program, for the equipment or similar equipment identified in Section B.1a. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment. |
| The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. 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 VISN 4 VA Medical Facilities. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VISN 4 VA Medical Facility 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 VISN 4 VA Medical Facility equipment. |
| Any Contractor personnel must provide a copy of: 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate. |
PERFORMANCE STANDARDS
| The chart below outlines performance objective, standards, quality levels, and surveillance |
| methods that serve as a basic rubric for Contractor performance evaluation under the |
| contract terms. Confirmation of these delinquent performances will be made known to the |
| Contractor immediately upon discovery and reflected in CPARS. |
Performance Objective Standard Acceptable Quality Level (AQL) Surveillance Method All equipment on contract must have a 97% uptime.
The contractor must guarantee 97% uptime of all equipment under contract. Downtime will be calculated from the time a call is placed to the time of repair completion and the equipment being fully functionable between the contracted Monday-Friday 8am-5pm time.
97% uptime for all contracted equipment Observation or validated user or customer complaints.
Documentation Reports Draft copies of deliverables will be provided to biomedical engineering staff at the medical facility prior to the contractor leaving the facility. If a final copy is available at that time a draft will not be necessary.
Draft copy or final copy due prior to contractor leaving the facility. If draft copy is given at time of service, a final copy must be provided within 5 days of the deliverable.
Observation or validated user or customer complaints.
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