VA OIT RFQ: Blood Establishment Computer Software (VBECS) Blood Bank Equipment QS Audit Services

Notice ID:  6C10B24Q0550

Services are for a compliance audit of the VistA – Blood Establishment Computer Software (VBECS) product Quality System. VBECS is used by the VA to create and support medical device software thereby meeting Food and Drug Administration Title 21 CFR Part 11, 803, 806, 820, and 821 regulations. The Contractor conducting the service must be a Certified Auditor with the International Register of Certificated Auditors (IRCA) or a Certified Quality Auditor with American Society for Quality (ASQ). The audit will include a desk audit of documentation and a site visit of two to three days for additional review, interviews, and discussion. The audit but must completed no later than three months after contract award. A report summarizing the findings and recommendations is a required work product.

The Contractor conducting the service must be a Certified Auditor with the IRCA or a Certified Quality Auditor with the ASQ. The Contractor shall perform the following:

• Conduct an audit of VBECS compliance with applicable FDA Title 21 CFR Part 11, 803, 806, 820, and 821 regulations.
• Review each element of the FDA regulated Quality System (QS) used by VBECS to create and support the VBECS medical device.
• Comment on the effectiveness, adequacy, and regulatory compliance of the VBECS QS. The contractor will point out any non-compliance and recommend strategies to bring the project into compliance.
• Review available records and confirm the information they contain through interviews, observations, and requests for additional information. Quality System records that may be reviewed for objective evidence include:
  • Prior internal and external audit findings. o Management reviews.
  • Corrective action documentation.
  • Change control documentation.
  • IOPs and policies. o Organizational charts.
  • Team roles and responsibilities.
• Review materials being audited, methods used and findings identified with assigned team members daily.
• Hold a summation meeting, detailing audit findings, with the VA Project Manager (PM), appropriate VBECS team members, and the VBECS Compliance Officer.
• Present a written, preliminary report of audit findings to the PM or designee at the completion of the audit.

The contract will be written for a base year with Two (2) 12-month option years.

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