BloodBank Validation Services

Request for Information (RFI)

This RFI is issued by the Department of Veterans Affairs, Office of Information & Technology, to gauge industry interest and gather information for Blood Bank Validation Services. Companies interested in participating are asked to submit responses to specific items.

Respondents are requested to provide:

• Their business size classification (SDVOSB, VOSB, other small business) and relevant NAICS codes.

• Any questions, concerns, or comments regarding the Draft Performance Work Statement (PWS).

• A capability statement (limited to 5 pages and 5 MB) detailing the company's ability to meet the draft PWS requirements, including relevant experience and references.

• RFI submissions should be sent to the identified Points of Contact (POCs).

• Questions and RFI responses should be directed to Steven Baum (steven.baum@va.gov) with a CC to Wendella Baptiste (wendella.baptiste@va.gov).

Information is requested regarding the respondent's business size and type (SDVOSB, VOSB, other small business).

This is a Request for Information (RFI) and not a solicitation for proposals. The draft PWS is referenced as an attachment.

Statement of Work (SOW) / Performance Work Statement (PWS)

This Performance Work Statement (PWS) outlines the requirements for blood bank validation services to support the Department of Veterans Affairs (VA) Electronic Health Record Modernization Integration Office (EHRM-IO) in their migration from VistA to the Oracle Health (OH) Millenium EHR. The objective is to ensure the validation of the Oracle Health Pathnet Blood Bank system before its go-live at various VA medical centers.

The contractor will provide Project Management, System Review, Documentation Review, Validation Planning, and Validation Services. This includes:

• Project Management: Developing and maintaining a Contractor Project Management Plan (CPMP) and providing weekly and monthly progress reports.
• Blood Bank Validation: Performing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Computer System Validation, and Risk Assessment for VA blood bank locations. This involves validating critical system messages, order entry, product handling, crossmatch processes, and other system functionalities.
• Enterprise Validation Plan: Developing an Enterprise Blood Bank Validation Plan, including a t-minus schedule and template for site-specific validation plans.
• Validation Execution: Executing site validation plans, including reviewing SOPs, system reviews, test script content, and documenting test execution, anomalies, and risk assessments.
• Optional Task (Site Blood Bank Validations): Performing blood bank validations for specific sites as identified in option exercises.

Performance will be assessed based on:

• Technical/Quality of Product or Service: Understanding requirements, efficiency, meeting technical needs, providing quality services, and incorporating Human-Centered Design.

• Project Milestones and Schedule: Meeting established milestones and project dates, timely delivery of products, and advance notification of potential problems.

• Cost & Staffing: Maintaining appropriate expertise and staffing levels, and possessing necessary knowledge, skills, and abilities.

• Management: Effective integration and coordination of all activities.

• Performance Period: One (1) 12-month base period with four (4) 12-month option periods.

• Place of Performance: Contractor facilities or telework with prior approval. Government site work is subject to Federal holidays and weekends.

• Travel: The Government does not anticipate travel under this effort.

• Security and Privacy: Protected health information may be disclosed, requiring a signed Business Associate Agreement (BAA). Contractors must comply with all VA security and privacy directives and handbooks, including those related to PII, SSN reduction, and background investigations.

• IT Framework: Compliance with VA Enterprise Architecture, Federal Identity, Credential, and Access Management (FICAM), IPv6, and Trusted Internet Connection (TIC) standards.

• Government Furnished Property: The Government may provide up to fifty-five (55) laptops. The contractor is responsible for other IT accessories.

• Deliverables: Contractor Project Management Plan, Weekly Progress Reports, Monthly Progress Reports, Approved Enterprise Validation Plan, Approved Site Validation Plan, Final Site Validation Report.