P09 SOW UroNav Ultrasound.pdf

SPECIFICATIONS/WORK STATEMENT

(Surgical Service)

The UroNav and Ultrasound Rental

CTVHCS

02/08/23

1. CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COR): CTVHCS will appoint one (1) COTR for this contract. The contractor will always contact the COR prior and after service is rendered. COR: TBD

2. SCHEDULING ARRANGEMENTS: Except by special alternative arrangement, scheduled delivery will be provided only during Contractor’s normal working hour’s local site time. Upon acceptance of this contract, the Contractor shall immediately contact the COR: TBD to schedule mutually agreeable delivery times.

3. SCOPE OF WORK: Rental of UroNav, ultrasound and components for Central Texas Surgical Service Temple, 1901 Veterans Memorial Dr, Temple, Texas, 76504 and Central Texas Surgical Service Austin, 7901 Metropolis Dr, Austin, Texas 78744. Delivery activities shall consist of the following:

A. Delivery of loaner/rental UroNav, ultrasound and all components to VA facility B. Perform all preparations required for loaner/rental UroNav and ultrasound use.

C. Post use inspection.

D. Transportation of loaner/rental UroNav, ultrasound and all components back to rental facility after each use.

E. Vendor shall, as appropriate, provide training and support.

Upon receiving call from CTVHCS for services, the contractor will provide a confirmation of services within 4 hours of the initial service request. Loaner equipment components that require cleaning/sterilization needs to be submitted 48 hours in advance to Sterile Processing Service (SPS) for cleaning/sterilization. The VA is not responsible for any lost case revenue.

That is the sole responsibility of the awarded vendor. In the case of equipment malfunction, the vendor will repair the equipment within 1 week or provide a replacement. Training and support and preventative maintenance and educational courses to be provided on-site if required.

The vendor will provide all resources required to ensure a smooth transition, in accordance with the contract requirements.

4. DESCRIPTION OF PROVIDED EQUIPMENT:

A. Equipment

a. UroNav MRI Fusion Biopsy System P/N10880

b. Ultrasound UroNav P/N10917

c. Ultrasound UroNav BK5000 Triplane Probe 9018 P/N11191

d. Ultrasound Needle Guide Dual P/N10916

e. Ultrasound Latex Free Probe Cover P/N10887

f. UroNav BK 8808e/8818 Probe Holder P/N10907

g. Delivery Fee P/N10554

h. Early Accessory Drop Off Fee P/N10595

5. PERSONNEL CLEARANCES AND PRIVACY CONSIDERATIONS: The Contractor will ensure that their personnel and subcontractor personnel meet the privacy standards as set forth by

HIPAA (Health Insurance Portability and Accountability Act of 1996) with respect personal and confidential information that they may come upon, while servicing medical equipment.

a. Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS).

b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA.

c. Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually.

d. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA.

e. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request.

6. DOCUMENTATION: Contractor will provide the COTR with individual written reports which describe the maintenance and repair service performed on the equipment under warranty in sufficient detail so as to be acceptable by field inspectors of the Joint Commission and other inspecting bodies. This shall include a list of all parts replaced, all service performed as well as a statement that the equipment is operating per manufacturer’s specifications after repair. The service report will be signed by the contractor’s service technician, and by designated VANTHCS personnel.

a. Prior to award, bidder must have a facility to include personnel, test equipment, parts inventory, training certificates, licenses and technical documentation available for inspection by VA Medical Center personnel and be able to show written evidence to technical qualifications of personnel, test equipment (and calibration documentation) licenses and availability of parts. Parts availability must be written documentation from either the equipment manufacturer or authorized parts supplier. In either case, bidder must be able to show the availability of parts to him/her within 24 hours after initial call. For contracts for maintenance and repair services form other than the original manufacturer or a designated representative, the Contractor will be fully responsible for obtaining all technical documentation necessary to fulfill contractual obligations.

b. The Contractor warrants that the services to be performed under this contract will be performed in a good workmanship manner and shall conform to the standards of the industry. This warranty is given expressly and in place of all other warranties, expressed or implied, statutory, or otherwise, and is the only warranty given by the Contractor.

7. NEGLIGANCE CLAUSE: When services and parts are required as a result of accident, abuse, misuse or negligence by other than the Contractor or his representative, and are not included as a part of PM inspection or service calls, such needs will be reported to the Contracting Officer’s representative along with estimates of charges. The Contracting Officer and Representative will evaluate these needs and authorize appropriate action. The parts will be installed under the terms of the contact and each invoice is to include a legible itemized list of labor charges and parts costs.

The government will incur no charges for service and parts including glassware due to accident, abuse, misuse or negligence by the contractor or his representative.

8. RECORDS MANAGEMENT:

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, 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. VA North Texas Health Care System 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 VA North Texas Health Care System or destroyed except for 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, Contractor must report to VA North Texas Health Care System. 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 VA North Texas Health Care System 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 VA North Texas Health Care System 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 VA North Texas Health Care System policy.

8. The Contractor shall not create or maintain any records containing any non-public VA North Texas Health Care System information that are 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 VA North Texas Health Care System 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 VA North Texas Health Care System 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, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

12 END OF CONTRACT: Contractor guarantees that all equipment covered in this contract shall meet or exceed manufacturer’s performance specifications at the contract expiration date.