P01 - Statement of Work - Bone Saw.docx

STATEMENT OF WORK – ACQUISITON OF PATHOLOGY BONE SAW

PURPOSE: The purpose of this request is for a one-time acquisition of a pathology bone saw. The bone saw is designed to make grossing tissue bone specimens easier for the pathologist and pathology assistants. It dramatically reduces processing time for sample preparation and in turn reduces time from grossing to reporting. Request provides purchase of the bone saw and all required accessories.

SECTION A - WORK STATEMENT

1. SCOPE: Vendor will provide delivery of purchased equipment and any parts required for optimal performance of the system. Vendor delivery responsibility includes:

a. Shipment

b. White-glove Delivery to site of installation

c. Saw Install and set-up.

d. System performance check

e. Required periodic preventative maintenance and intermittent troubleshooting assistance and onsite repair.

f. Provide basic and advanced operator training as needed.

2. LOCATION: The pathology saw will be utilized in Histology section of Rm 1B-328, Pathology and Laboratory Medicine Service at North Texas VA Healthcare System, 4500 S. Lancaster Rd, Dallas, TX 75216.

3. CAPABILITY REQUIREMENTS: The following are required w/ purchase:

a. Requirements are as follows:

1) Stainless steel tabletop saw capable of precision cutting down to ~1mm

2) Splash guard

3) Standard blade saw

4) Cooling water for the blade cleaning

5) Cutting guide for cutting specimens

b. On-site Repair/Maintenance/Technical Support:

1) All repair and maintenance will be handled in coordination with the NTVHCS Biomed department.

2) For issues that the Contractor determines to require on-site assistance, Contractor shall dispatch one or more Support Personnel, normally within 48 business hours after documentation.

3) Contractor shall submit a detailed work report to include all required materials.

4) Contractor shall provide all parts and materials at no additional cost to the government.

5) Contractor shall remove all parts, equipment or materials replaced or upgraded by the Contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government.

6) Support personnel will be available during business hours each business day, and live representatives will be available via telephone at all other times, whether dispatched by Contractor or technical support line.

7) Technical support shall be available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer service inquiries when necessary.

8) On-site technical support shall be available for escalations within 48 hours.

c. Safety: Contractor shall immediately notify VANTCHS of any changes in procedure modification, recall notification, parts notification, or any changes that will affect the performance of the instrument according to FDA regulations.

d. Test Performance:

1) All equipment must perform at manufacturer’s specifications. Deviations from the performance specifications shall be corrected by Contractor at no additional cost to the government.

2) Vendor shall reimburse VANTHCS for any costs incurred related to performance due to instrument issues or failure. The assessed damages will be applied to invoice as a credit.

e. Warranty:

1) Contractor shall provide a service warranty to begin immediately after installation and to extend at least one (1) full year (365 days).

2) Additional service warranty contracts will be available for purchase through coordination with VANTHCS Biomedical department.

4. DELIVERABLES AND SUPPLIES:

a. Contractor shall deliver all supplies necessary for equipment performance at no cost to the government.

b. Contractor shall deliver (at no additional cost) all and not limited to operational, maintenance, troubleshooting, small repair, equipment specifications, and document material.

c. In the event requested parts are unavailable, Contractor is to provide estimated time of availability.

d. Any equipment modifications, updates, recalls, etc. will be immediately disclosed by the Contractor electronically as well as by postal mail with supporting documentation of the change, and detailed guidance for implementation withing twenty-four hours of its application.

5. CONTRACTOR SECURITY CONTRACT REQUIREMENTS: Contractor requires no access to VANTHCS or any VA information system. No equipment will be interfered with any VANTHCS information systems. If LIS integration is requested later, all necessary security contract requirements will be modified and granted as the government sees fit prior to information systems access.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

6. EVALUATION CRITERIA: The Contractor shall provide the following documentation with their offer:

· Pathology Bone Saw includes:

· Stainless steel composition

· Standard bone saw

· Blade-cleaning water option

· Splash guard for safety

· Cutting guide for precise, detailed cutting

SECTION B: RECORDS AND QUALITY

1. Records Management: All records (administrative and program specific) created during the period of the contract belong to VANTHCS must be returned to VANTHCS at the end of the contract.

2. Quality Assurance Surveillance Plan (QASP): The Contractor shall be evaluated for Quality, Scheduling, Cost Control, Management, Regulatory, and Customer Satisfaction for the Base and each Option year. Scoring Criteria and Incentives are outlined below:

Scoring – Average score value per category:

· Exceptional – 4

· Very Good – 3

· Satisfactory – 2

· Marginal – 1

· Unsatisfactory <1

SECTION C: NARA RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS (MAY 2017)

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. VANTHCS 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 VANTHCS 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 VANTHCS. 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 are 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 are no longer required, it shall be returned to VANTHCS 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 VANTHCS 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 VANTHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public VANTHCS 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. VANTHCS 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 VANTHCS 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.