SAM #VA2500023242v2

VA Solicitation for Blood Bank Validation Services Supporting Oracle Health EHR Transition

The Department of Veterans Affairs (VA) is seeking contractor support for Blood Bank Validation Services as part of its Electronic Health Record Modernization (EHRM) initiative. - Government Buyer: - Department of Veterans Affairs, Electronic Health Record Modernization Integration Office - OEMs and Vendors: - Oracle Health (as the EHR platform; no other OEMs or vendors specified) - Products/Services Requested: - Blood Bank Validation Services for the Oracle Health Pathnet Blood Bank system at 109 VA Medical Centers - Includes validation of system build, configuration, orderables, interpretation patterns, blood products, instrumentation connectivity, and patient product compatibility - Validation services cover Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Computer System Validation, and Risk Assessment - Project management support, including development of a Contractor Project Management Plan (CPMP) and regular progress reporting - Delivery of an Enterprise Blood Bank Validation Plan, site-specific validation plans, and final validation reports - Optional site validations for Boise VA Medical Center (Idaho) and Portland VA Medical Center (Oregon) - Unique/Notable Requirements: - Validation must ensure compliance with VA, FDA, AABB, CLIA, and The Joint Commission standards - Adherence to VA IT security, privacy, and accessibility requirements - Up to 24 go-live events anticipated, with validation services starting up to four months prior to each site go-live and lasting up to 12 weeks per site - Work at government sites excludes federal holidays and weekends unless otherwise directed - Place of Performance: - Primarily at contractor's facility, with site-specific work at VA Medical Centers including Boise and Portland

Description

This is a Request for Information (RFI) only, and is being issued for the sole purpose of conducting market research and to determine a viable path for solicitation. Please see the two (2) attachments for full details and instructions.

The mission of the VA Electronic Health Record Modernization Integration Office (EHRM-IO) is to transform how the VA delivers health care by implementing an enterprise-wide electronic health record (EHR) to standardize care across facilities, strengthen interoperability and collaboration with federal and community partners, foster innovation, improve provider and Veteran experiences, and ensure the continued delivery of high-quality, safe, and efficient health care to our nation’s Veterans. EHRM-IO is in the process of migrating VA’s Medical Centers (VAMCs) from the Veterans Information Systems and Technology Architecture (VistA) to the Oracle Health (OH) Millennium EHR.Many of these VAMCs operate a blood bank and/or perform transfusion services and will be using the Oracle Health Pathnet Blood Bank system after go-live. Validation Services are required by regulatory and accreditation organizations (VA, Food and Drug Administration (FDA), Association of Advancement of Blood and Biotherapies (AABB), Clinical Laboratory Improvement Amendments (CLIA) and The Joint Commission (TJC)) to ensure patient and blood products safety. Compliance with the Food and Drug Administration (FDA) Regulations requires that these environments are validated prior to go-live.

EHRM-IO seeks a contractor to provide blood bank validation services at each site with Full Blood Bank/Transfusion Medicine Services and those with transfusion only services to validate the build and configuration of the system, both for the local site build and enterprise review of all orderables, interpretation patterns, blood products, instrumentation connectivity and patient product compatibility.

Instructions for Submitting Questions and the RFI Response: The VA Technology Acquisition Center POCs for this RFI are Contract SpecialistSteven Baum and Contracting Officer Wendella Baptiste. Please submit questions/responses directly to steven.baum@va.gov, with a CC to wendella.baptiste@va.gov. Questions/clarifications are welcome prior to your response, and may be used to sharpen/ clarify our documentation in the hopes of improving any eventual solicitation. The Government shall compile all questions and issue a RFI Amendment to provide answers, and extend the due-date for responses if necessary to allow vendors time to take the Q&A responses into consideration prior to providing their RFI response. Please submit only one set of questions. Please see the RFI attachment and respond to the specific prompts in your response.

This RFI constitutes neither a Request for Proposal (RFP) nor a guarantee that one will be issued by the Government in the future. Furthermore, it does not commit the Government to contract for any services described herein. Do not submit a Proposal. The Department of Veterans Affairs (VA) is not, at this time, seeking proposals or quotes, and therefore, will not accept, review, or evaluate unsolicited proposals or quotes received in response hereto. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government does not reimburse respondents for any costs associated with submission of the information being requested or reimburse expenses incurred for responses to this RFI. The information provided may be used by VA in developing its acquisition strategy and Performance Work Statement (PWS). Any information submitted by respondents to this RFI is strictly voluntary; however, any information received shall become the property of the Government and will not be returned to the respondent.

NOTE: The place of performance listed is the TAC address as a placeholder. Performance shall be at the contractor facility.

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