Statment of Work Alere.pdf

RALS Statement of Work For AVOX 1000e and ITC Hemochron Signature Elite

PURPOSE

The purpose for obtaining the Remote Automated Laboratory Systems (RALS) software technology is to connect multiple devices to one data manager. The RALS software enables review and release of patient results to the LIS directly from each unit. It allows the ability to manage, update, review and troubleshoot quality control results, operator and device issues remotely. Currently we have RALS for our glucometers and would like to add the additional modules for the ITC AVOX 1000e point-of-care instruments and for the ITC Hemochron Signature Elite instruments.

SCOPE OF WORK

The Remote Automated Laboratory Systems (RALS) Software Technology System (STS) License Agreement is part of the point of care testing connectivity software that is used to post patient test results to the electronic patient record (VISTA/CPRS). This software allows the end user to monitor tests done at the point of care and to meet numerous accreditation requirements for laboratory tests performed at the Wilkes-Barre VA Medical Center, 1111 East End Blvd, Wilkes-Barre PA 18711.

LOCATION

For Avoximeter: This module is specific for instrumentation used for Oximetry (Total Hemoglobin and Oxyhemoglobin) testing on the AVOX 1000e performed in the Cardiac Cath department.

For Hemochron: This module is specific for instrumentation used for Activated Clotting Time (ACT) testing on the Hemochron Signature Elite performed in the Anesthesia and Cardiac Cath departments.

PERIOD OF PERFORMANCE

The software license agreement ensures a continuity of services for this medical center utilizing the same server which is part of this contract. The term of this license agreement shall commence as of the license effective date and shall remain in effect as long as the STS is licensed hereunder. The term of each license granted hereunder shall remain in effect for duration of the purchase order. The Technology License includes service, support, updates and hardware maintenance. The supply of RALS-Plus for the use by Customer is governed by the terms and conditions of the RALS Software Technology System License Agreement.

Period of performance consists of one base year and four option years with base year starting on 9/2/2024 ending on 9/1/2025.

DELIVERABLES/SUPPLIES for Avoximeter The contractor Abbott/Alere Informatics Inc. shall provide RALS Plus ITC AVOX devices module and interfacing and download sites to include:

1. Software Components:

• RALS-Plus device software module for the ITC BLOOD OXIMETER AVOX 1000e or 4000

• RALS-LIS HL7 Interface (LIS is VistA).

• RALS Remote Connect (RRC), if applicable

• Other third-party software, depending on system specifications.

2. Other Components:

• RALS User Documentation will be provided in the current medium.

Standard Training, instruction and consultation for the Customer required for the use of the RALS STS.

3. Hardware Components Provided by Alere Informatics Inc RALS Dataports if applicable Information Management System

4. Standard training, instruction, and consultation for the customer required for the use of the RALS STS.

DELIVERABLES/SUPPLIES for Hemochron The contractor Alere Informatics Inc. shall provide RALS Plus ITC Hemochron devices module and interfacing and download sites to include:

1. Software Components:

• RALS-Plus device software module for the ITC HEMOCHRON SIGNATURE

ELITE

• RALS-LIS HL7 Interface (LIS is VistA).

• RALS Remote Connect (RRC), if applicable

• Other third-party software, depending on system specifications.

2. Other Components:

• RALS User Documentation will be provided in the current medium.

Standard Training, instruction and consultation for the Customer required for the use of the RALS STS.

3. Hardware Components Provided by Alere Informatics Inc.

RALS Data ports if applicable Information Management System

4. Standard training, instruction, and consultation for the customer required for the use of the RALS STS.

CONFORMANCE STANDARDS:

The contractor’s performance must be in compliance with all applicable state, federal and local laws and regulations.

HOURS OF WORK:

The Warranty is in effect for the entire duration of the contract.

The contractor provides 24 hour, 7 days a week Technical Support by calling 1-877-627-7257.

PREVENTATIVE MAINTENANCE:

1. The Contractor shall provide free upgrades at no cost to the medical center

2. The Contractor provides documentation of services performed.

EMERGENCY REPAIR SERVICE:

24 hour, 7 days a week Technical Support by calling 1-877-627-7257.

PARTS

The contractor shall furnish all parts as described in the Scope of Work section as covered by this contract, in accordance with the Conformance Standards Section (section II).

NARA Records Management Language for Contracts (May 2017):

https://www.archives.gov/records-mgmt/handbook/records-mgmt-language.html

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 Wilkes-Barre VAMC records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

https://www.archives.gov/records-mgmt/handbook/records-mgmt-language.html

4. may include deliverables and documentation associated with deliverables.

C. Requirements

The following standard Items relate to records generated in executing this contract and should be included in a typical contract where records could possibly be created, maintained or dispositioned:

ADD THE FOLLOWING 10 ITEMS TO THE STATEMENT OF WORK (SOW):

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. Wilkes-Barre VAMC 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 Wilkes-Barre VAMC 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 Wilkes-Barre VAMC. 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 Wilkes-Barre VAMC 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 Wilkes-Barre VAMC 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 Wilkes-Barre VAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public Wilkes-Barre VAMC 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 Wilkes-Barre VAMC 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 Wilkes-Barre VAMC 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.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown 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.