P01- CORE TOX SOW.docx

STATEMENT OF WORK

North Texas Veterans Health Care System Agreement for Procurement of Reagents, Kits and supplies for Core Lab/Toxicology Testing

1. Purpose: The North Texas Veterans Health Care System (VANTHCS) is requesting a contract for the procurement of reagents and supplies for Core Lab/Toxicology testing for the period of a base plus four option years.

2. Scope and Location: Contractor shall deliver all reagents and supplies listed below for VANTHCS Pathology & Laboratory Medicine Service to Dallas, Core Lab at 4500 Lancaster Rd., Dallas, Texas 75216.

*ALL reagents and supplies must perform according to manufacturer’s guidelines.

4. Period of Performance:

Base year: June 1,2026 -May 31,2027 Option Year 1: June 1, 2027- May 31,2028 Option Year 2: June 1, 2028- May 31,2029 Option Year 3: June 1, 2029- May 31,2030 Option Year 4: June 1, 2030- May 31,2031

5. Deliverables/Supplies:

All items listed in the document are to be supplied by one vendor. No substitutions of kits, supplies or reagents, or components as the request is for items used for current validated testing. Items will be ordered as needed by Core Lab staff.

6. Vendor Security Contract Requirements: This vendor requires no access to VANTHCS or any VA information system.

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

7. Records Management: All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.

8.PERSONNEL QUALIFICATIONS: The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this SOW. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. The working history of each contractor employee must contain experience directly related to the task and functions he/she intends to perform under this contract. The Government reserves the right, during the life of the resulting contract, to request work histories on any contractor employee for the purpose of verifying compliance with the above requirements; additionally, the Government reserves the right to review resumes of contractor personnel proposed to be assigned. Personnel assigned to, or utilized by, the Contractor in performance of work shall be fully capable of performing the requirements contained in the /SOWPWS in an efficient, reliable, and professional manner. The normal manner of dress is business casual.

a. Specific Personnel Qualifications Requirements –Personnel assigned to or utilized by the contractor in the performance of this contract shall, as a minimum:

Be qualified by the contractor as capable of performing as a field service representative.

9. PERFORMANCE STANDARDS AND QUALITY MEASUREMENT:

a. Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL). The Quality Assurance Surveillance Plan (QASP) method of surveillance will be by random inspection.

b. Performance Evaluation: After acceptance of the contract the system will be monitored for equipment performance including but not limited to; safety (recall Notifications and changes in reagents and equipment notifications), quality assurance (emergency repairs response, hot line troubleshooting response, quality of results compared to peer groups and CAP performance) and documentation (invoice accountability and invoice verification, equipment specification and user manuals), customer satisfaction (response to complaints and laboratory employees training).

10. NARA RM LANGUAGE CLAUSE: 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.

a. 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.

b. 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.

c. 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.

d. 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.

e. 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).

f. 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.

g. 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.

h. 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.

i. 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.

j. 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 #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

12. PRIVACY: Contractors and 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).

a. 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.

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

c. 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.

d. 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.

References:

VHA Directive 6300 VA Handbook 6300.1 North Texas VA Medical Center Policy VA Directive 6500 36 CFR Part 1222.32 (b)