P02_DRAFT STATEMENT OF WORK VANCHCS_RALS.docx

Statement of Work

VA NORTHERN CALIFORNIA 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 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). 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 throughout the VA Northern California Healthcare System located at 10535 Hospital Way Mather, CA 95655.

Software must be compatible with Roche Accuchek Inform II (80 meters) , the Abbott iSTAT (4 meters), the Siemens EPOC (9 meters) , Signture Elite Hemochron (3 meters), Avox 1000E (2 meters) and 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 VANCHCS is governed by the terms and conditions of the Alere’s Informatics RALS Software System and Support Master Agreement.

4. Performance Period: This contract shall be for a base period of 6/1/2023-5/31/2024. 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.

5. 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 for the Roche Accu-Chek Inform II glucometers

ii. RALS-RALS Web3 device software module for the Siemens EPOC blood gas analyzers.

iii. RALS-RALS Web3 device software module for the Abbott iSTAT analyzers.

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

v. RALS Remote Connect (RRC), if applicable

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

vii. ADT Interface; ADT In-Unit Patient Verification with positive patient identification.

viii. RALS eQuiz

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

2. 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.

C. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

D. CONTRACTOR SECURITY REQUIREMENTS

1. This contractor requires no access to VANCHCS or any VA information system. The RALS will be interfaced to the VANCHCS information system.

2. The C&A requirements do not apply. A Security Accreditation Package is not required.

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

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

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

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

7. All hard drives will not leave the VA.

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

E. RECORDS MANAGEMENT

All records (administrative and program specific) created during the period of the contract belong to AVAHCS and must be returned to AVAHCS at the end of the contract.

F. QUALITY ASSURANCE SURVELLIANCE PLAN (QASP)

The QASP and its performance are as follows: