Statement of Work-RALS.pdf

VA TEXAS VALLEY COASTAL BEND HEALTH CARE SYSTEM

PATHOLOGY AND LABORATORY MEDICINE SERVICE

STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: Remote Automated Laboratory System (RALS)

2. 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.

3. 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. The contractor shall provide uninterrupted RALS software licensing and interface for 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 VA Texas Valley Coastal Bend Health Care System (VATVCBHCS) medical facilities; main lab offices which are located at 2601 Veterans Drive, Harlingen, TX 78550.

Software must be compatible with Roche Accu-Chek Inform II glucose meter, the VA’s LIS and electronic patient record system (VistA/CPRS). The software must have the capability to add more instruments as the need arises. The Technology License includes service, support, updates and hardware maintenance. The supply of Alere’s Informatics RALS Web3 for the use by the VATVCBHCS is governed by the terms and conditions of the Alere’s Informatics RALS Software System and Support Master Agreement.

4. Performance Period: The period of performance of this contract shall consist of one

12-month base period. At the discretion of the Contracting Officer, the Government may exercise up to four 12-month option periods and will be in the Price Schedule.

The software license agreement ensures a continuity of services for this medical center utilizing the server which is already in place. 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 Technology License shall include service, support, updates, and hardware maintenance. The supply of RALS-RALS Web3 for the use by Customer is governed by the terms and conditions of the RALS Software System and Support Master Agreement.

5. Background: These analyzers are currently interfaced using the RALS data management software since 2011. Texas Valley Coastal Bend is also using RALS data management to point of care analyzer in the McAllen Urgent Care. Point of Care devices include, iSTAT, Sofia, Clinitek.

6. Type of Contract: This is a firm fixed price contract.

B. GENERAL REQUIREMENTS

1. The contractor shall provide the RALS Web3 devices module to include:

a. Software Components:

i. RALS-RALS Web3 device software module Version 6.0, for the

Roche Accu-Chek Inform II glucometers

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

iii. RALS Remote Connect (RRC), if applicable

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

b. Other Components:

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

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

c. Hardware Components provided by the vendor:

i. RALS Data ports, if applicable

ii. Information Management System

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

2. Language: All written deliverables shall be phrased in layperson language.

Statistical and other technical terminology shall not be used without providing a glossary of terms.

3. Conformance Standards: The contractor’s performance must follow all applicable state, federal and local laws and regulations.

4. 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.

5. Preventative Maintenance:

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

b. The Contractor provides documentation of services performed.

6. Emergency Repair Service: 24 hour, 7 days a week Technical Support.

7. 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 B., 3).

A. The COR and the Contractor will assure that:

1. No other information except what is in this contract will be shared with the contractor in any follow up communication.

2. None of the information in this contract includes Protected Health Information (PHI) or Individually Identifiable Information (III).

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

4. The vendor will not have remote access to complete the repair(s) and preventive maintenance.

5. ALL DATA AND ELECTRONIC MEDIA WILL NOT LEAVE THE VA.

6. All hard drives will not leave the VA.

7. Vendor will have supervised access when onsite performing service/maintenance.

RECORDS MANAGER

There will be no federal records created, maintained, used, or dispositioned with this contract:

regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.]

Information Systems Officer, Information Protection:

The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer:

The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

Records Manager:

Records Officer: There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].

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. TXVCBHCS 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 TXVCBHCS 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 TXVCBHCS. 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 TXVCBHCS 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 TXVCBHCS 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 TXVCBHCS policy.

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

(END OF STATEMENT OF WORK)

VA TEXAS VALLEY COASTAL BEND HEALTH CARE SYSTEM