SOW ELP RALS.pdf

Statement of Work

RALS Statement of work Accu-Chek Inform II, CoaguChek XS Plus, Abbott ID NOW, Siemens Clinitek Status +

A. General Information

1. The El Paso VA Health Care System, Pathology and Laboratory Medicine Service is seeking to obtain Remote Automated Laboratory Systems (RALS) software to connect

Accu-Chek Inform II, CoaguChek XS Plus, Abbott ID NOW and Siemens Clinitek Status + analyzers to one data manager. The software enables review and release of patient results to the Laboratory Information System (LIS) directly from each analyzer. It allows the ability to manage, update, review and troubleshoot quality control results, operator and device issues remotely.

2. Scope of Work: The contractor shall provide 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). The vendor must install and configure all software to work with our current LIS. 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 El Paso VA Health Care System, located at 5001 N. Piedras, El Paso, TX

79930, East Side Community Based Outpatient, located at 2400 Trawood Drive, Suite 200, El Paso, TX 79936, Las Cruces Community Based Outpatient Clinic, located at 3401 Del

Rey, Las Cruces, NM 88012, South Central Wellness Center Community Based Outpatient

Clinic, located at 350 Revere Street, El Paso, TX 79905, Northeast Community Based

Outpatient Clinic, located at 5229 Sanders Ave, El Paso, TX 79924, West Side Community

Based Outpatient Clinic, located at 1870 Northwestern Drive, El Paso, TX 79912, East Side

Home Based Primary Care, located at 117 Pershing Road Room 113, Fort Bliss, TX 79906, and Las Cruces Home Based Primary Care, located at 2123 Telshor Court, Las Cruces, NM 880011.

3. Contracting Officer Representative (COR): Aldo Coronado (Medical Technologist)

Email: aldo.coronado@va.gov

Phone: 915-564-6100 x 6689

Address: N. 5001 N. Piedras St El Paso Texas. 79930

4. Background/Location: The Accu-Chek Inform II, CoaguChek XS Plus, Abbott ID NOW, and

Siemens Clinitek Status + analyzers are currently interfaced using the RALS software at the

El Paso VA Health Care System and all Community Based Outpatient Clinics to El Paso

Veterans Affairs’ LIS and electronic patient record system (VistA/CPRS). The software must have the capability to add more instruments as the need arises.

5. The Period of Performance: This contract shall be for a base period and 4 option years 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 System Software Technology is licensed hereunder. The term of each license granted hereunder shall remain in effect for the duration of the purchase order. The

Technology License needs to include service, support, updates and hardware maintenance.

B. General Requirements

The contractor shall provide the device module to include:

1. Software Components:

• RALS Web3 device software module for Accu-Chek Inform II glucometers, CoaguChek XS

Plus meters, Abbott ID NOW analyzers, and Clinitek Status + analyzers.

• Bi-directional LIS HL7 Interface (LIS is VistA).

• Remote Connect (RRC), if applicable

• Other third-party software, depending on system specifications

2. Other Components:

• User Documentation will be provided in the current medium

• Standard Training, instruction and consultation for the Customer required for the use of

System Software Technology.

3. Hardware Components provided by the vendor:

• RALS data ports, if applicable

• Information Management System

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

System Software technology (SST) with an on-site training option.

Conformance Standards - The contractor’s performance must follow 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.

Preventative Maintenance

1. The Contractor shall provide free upgrades at no cost to the El Paso VA Healthcare System

2. The Contractor provides a detailed work report of services performed.

Emergency Repair Service

24 hours, 7 days a week Technical Support.

Parts

The contractor shall furnish all the parts described in the Scope of Work section as covered by this contract.

C. 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 electric 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.

2.2. NARA Records Management Language for Contracts

a) 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.

b) 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.

c) 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.

d) El Paso Veteran Affairs Health Care System (EPVAHCS) 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 EPVAHCS 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.

e) In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to EPVAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

f) 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 EPVAHCS 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).

g) 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 EPVAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

h) The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with EPVAHCS policy.

i) The Contractor shall not create or maintain any records containing any non-public EPVAHCS information that are not specifically tied to or authorized by the contract.

j) 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.

k) The EPVAHCS 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 EPVAHCS 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.

l) 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)