Sample PWS Full Service Contract for Stryker Neptune.docx

Sample PWS: Stryker Neptune Unit Full Service Contract

Project Full Service Contract for Neptune Waste Management Units Background The VA Northern California Health Care System (VANCHCS) is in need for a full-service contract for our Stryker Neptune biological waste management units at Sacramento VA Medical Center in Mather, CA, Redding VA Outpatient Clinic in Redding, CA, and Martinez VA Outpatient Clinic in Martinez, CA. This full-service contract includes repairs, corrective and preventative maintenance, and replacement original equipment manufacturer (OEM) parts serviced by a vendor certified by the OEM.

System Requirements Contractor shall provide the following service:

Schedule This is for a base year plus four option year requirement.

Technical Requirements Solution shall have the following requirements:

· The Contractor will come on-site and provide two (2) semi-annual preventative maintenances per unit, per year in accordance with the VA’s preventative maintenance schedule due dates and shall specifically include the following:

· Preventive Maintenance (PM) inspections twice per year before the requested date provided by the VA, not to exceed 6 months between PMs.

· Preventative Maintenance including PM required parts, system verification, alignment, and adjustments are provided by the Contractor at no additional customer cost during the hours of coverage.

· Factory-trained and authorized service labor and travel required for PM are included at no additional customer cost during the hours of coverage.

· The Contractor shall furnish documentation such as equipment verification, including all measurement and calibration data to certify that the system is performing in accordance with the performance specifications. Such service reports shall be sent via email to VA Biomedical Engineering personnel within 48 business hours of the work being performed or before the VA maintenance due date, whichever is soonest.

· Vendor will provide all replacement filters needed for the PM.

· The Contractor will provide on‐site service calls in order to make necessary repairs and adjustments to the equipment.

· An unlimited number of repairs or replacements of the Equipment, due to damage associated with normal use and wear, including all parts and labor associated with mail-in services. Any exceptions shall be noted by the Contractor in writing prior to the initiation of the contract.

· Unscheduled, Emergency Service including parts, system verification, alignment, and adjustments are provided by the Contractor at no additional customer cost during the hours of coverage. Factory-trained and authorized service labor and travel required for unscheduled, emergency maintenance is included at no additional customer cost during the hours of coverage.

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

· Prioritized repairs over non-contracted customers, with no additional administration or approval process are provided.

· Technical support via phone, email, and web is provided during hours of service.

· Reliability updates are included.

· Certified OEM replacement parts are included.

· All freight costs associated with shipments of repairs and loaner Equipment to Customer’s facility are included at no additional customer cost.

· If applicable, Loaner Equipment during the period that Equipment is in Stryker’s possession for repair, except that all such loaner Equipment is subject to availability and Stryker’s Loaner Policy.

· The Contractor will provide and install equipment software updates as needed.

· Include at least 3 Designated Support Contacts from the vendor.

· Include POC for Technical Support Engineer.

· The Contractor shall furnish and replace standard parts at no cost. The Contractor shall have ready access to all replacement parts. All parts supplied shall be the original equipment manufacturer (OEM) or OEM certified which are fully compatible with existing equipment. The Contractor shall use new parts.

· Expedited shipping on parts, equipment and etc.

Standards Requirements

· Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, Federal and VA specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

· The Contractor shall comply with the Federal/California OSHA Biohazardous Waste Standards.

Security Requirements The C&A requirements do not apply, and that a Security Accreditation Package is not required.

Performance The Contracting Officer Representative (COR) shall monitor performance through routine inspections and maintain copies of all service records. Any issues will be brought up to Contractor’s service manager.

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. Any work not covered by the terms of this contract must be approved by the COR prior to initiation.

On-Site Service Contractor shall service the equipment at the VA Northern California Health Care System unless the COR approves of the service being completed at the applicable Stryker repair facility. Equipment may not be taken off-site for repair or service until the COR has approved its removal.

Contractor shall verify full functionality of the solution with VANCHCS before stating that service has been completed.

Contractor shall coordinate service during normal business hours, all onsite visits will be performed during the normal VANCHCS business hours (8:00 a.m. - 4:30 p.m.) Monday through Friday, except Federal holidays, unless otherwise specified. The Contractor may work outside normal business hours by arrangement with the COR if such services are provided without additional charge to the Government. Any overtime charges must be approved by the COR prior to the initiation of overtime work.

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:

NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COR BEFORE SERVICE IS COMPLETED!

Reporting Requirements The Contractor shall report to Biomedical Engineering to "check-in" upon arrival and prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person or by phone contact. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s). The FSE shall be required to check out with the Biomedical Engineering Department (location to be specified at time of contract award) and submit the ESR(s) to the COR. All ESRs shall be submitted to the COR for an "authorization signature." Such service reports shall be sent via email to VA Biomedical Engineering personnel within 48 business hours of the work being performed or before the VA maintenance due date, whichever is soonest.

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.

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 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 B, 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

C. 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 the VAMC. 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 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.

Competency of Personal Servicing Equipment “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 identified items in this document. 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 identified in this document.

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 the VAMC. 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 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.

Training Contractor shall provide necessary training, user manuals and ensure competency on operation and maintenance for the equipment. Contractor shall provide clinical and technical support if additional assistance is needed. Training will be given on replacing all user-replaceable filters.

Place of Performance

The selected vendor shall service equipment at the VA Northern California Health Care System.

There are three addresses where service shall be provided:

Sacramento VA Medical Center: 10535 Hospital Way, Mather, CA 95655.

Martinez VA Outpatient Clinic: 150 Muir Rd. Martinez, CA 94553.

Redding VA Outpatient Clinic: 3455 Knighton Rd, Redding, CA 96002.

All onsite visits will be performed during the normal VANCHCS business hours (8:00 a.m. - 4:30 p.m.) Monday through Friday, except Federal holidays, unless otherwise specified. The Contractor may work outside normal business hours by arrangement with the COR if such services are provided without additional charge to the Government. Any overtime charges must be approved by the COR prior to the initiation of overtime work.

Delivery

The selected vendor shall deliver any equipment or parts to VANCHCS, located at 10535 Hospital Way, Mather, CA 95655; at the Martinez Clinic location at 150 Muir Rd. Martinez, CA 94553; and at Redding VA Outpatient Clinic, 455 Knighton Rd, Redding, CA 96002.

Identification, Parking, Smoking, Cellular Phone Use and VA Regulations

The Contractor shall wear visible identification at all times while on the premises onsite. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. VANCHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the onsite. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search.

Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

Other Pertinent Information or Special Considerations The Contractor must follow all HIPPA rules, regulations and restrictions regarding disclosure of any personal identifying information observed during the service of the equipment.

Contractors must abide by VA policy, including policies under special circumstances such as the COVID 19 pandemic to include mandatory masking, social distancing, and screening upon entry.

References Definitions/Acronyms

L. OEM – Original Equipment Manufacturer M. TJC – The Joint Commission O. OSHA – Occupational Safety and Health Administration

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.