PWS QS Audit.docx

FDA Compliance Audit of VistA - Blood Establishment Computer Software (VBECS)

SIMPLIFIED ACQUISITION PROCEDURES (SAP) PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Office of Information & Technology

FDA Compliance Audit of VistA - Blood Establishment Computer Software (VBECS)

VA-24-00052711

PWS Version Number: 1.0

DESCRIPTION OF SERVICES

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.

PERFORMANCE DETAILS

PERFORMANCE PERIOD

The Period of Performance shall be July 1, 2024 – June 30, 2027. Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

PLACE OF PERFORMANCE

Tasks under this PWS shall be performed in VA Facilities located at the Government location, Hines Office of Information Field Office (OIFO), Hines, IL 60141. Work may be performed at remote locations with prior approval of the Contracting Officer’s Representative (COR).

SPECIFIC TASKS AND DELIVERABLES

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:

o Prior internal and external audit findings.

o Management reviews.

o Corrective action documentation.

o Change control documentation.

o IOPs and policies.

o Organizational charts.

o 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.

Within ten working days of the end of the audit, the Contractor shall forward a final internal audit report with supporting documentation to the VA PM.

REPORTING REQUIREMENTS

The Contractor shall provide the Contracting Officer’s Representative (COR) with a daily report when on site during the audit. At the conclusion of the audit, the Contractor shall hold a summation meeting and provide a preliminary report of the audit findings. A final report of the audit findings is required within ten working days from the end of the onsite audit and shall include any non-conformances found with a reference to the FDA regulation.

Deliverable:

A. Final Audit Finding Report

GENERAL REQUIREMENTS

ENTERPRISE AND IT FRAMEWORK

Not Applicable

SECURITY AND PRIVACY REQUIREMENTS

The work defined in this PWS does not release or carry a risk of exposure to any secure information

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Not Applicable

METHOD AND DISTRIBUTION OF DELIVERABLES

The Contractor shall deliver documentation in electronic format, unless otherwise directed in Section B of the solicitation/contract.

PERFORMANCE METRICS

The table below defines the Performance Standards and Acceptable Performance Levels for Objectives associated with this effort.

2. Efficient and effective in meeting requirements

3. Meets technical needs and mission requirementsProvides quality services/products Satisfactory or higher

2. Products completed, reviewed, delivered in accordance with the established schedule

3. Notifies customer in advance of potential problems Satisfactory or higher

The COR will utilize a Quality Assurance Surveillance Plan (QASP) throughout the life of the contract to ensure that the Contractor is performing the services required by this PWS in an acceptable level of performance. The Government reserves the right to alter or change the surveillance methods in the QASP at its own discretion.

Option Period At the Government’s discretion, two (2) option periods maybe exercised

FACILITY/RESOURCE PROVISIONS

The Government will provide office space, telephone service and system access when authorized contract staff work at a Government location as required in order to accomplish the Tasks associated with this PWS. All procedural guides, reference materials, and program documentation for the project and other Government applications will also be provided on an as-needed basis.

The Contractor shall request other Government documentation deemed pertinent to the work accomplishment directly from the Government officials with whom the Contractor has contact. The Contractor shall consider the COR as the final source for needed Government documentation when the Contractor fails to secure the documents by other means. The Contractor is expected to use common knowledge and resourcefulness in securing all other reference materials, standard industry publications, and related materials that are pertinent to the work.

VA may provide remote access to VA specific systems/network in accordance with VA Handbook 6500, which requires the use of a VA approved method to connect external equipment/systems to VA’s network. Citrix Access Gateway (CAG) is the current and only VA approved method for remote access users when using or manipulating VA information for official VA Business. VA permits CAG remote access through approved Personally Owned Equipment (POE) and Other Equipment (OE) provided the equipment meets all applicable 6500 Handbook requirements for POE/OE. All of the security controls required for Government furnished equipment (GFE) must be utilized in approved POE or OE. The Contractor shall provide proof to the COR for review and approval that their POE or OE meets the VA Handbook 6500 requirements and VA Handbook 6500.6 Appendix C, herein incorporated as Addendum B, before use. CAG authorized users shall not be permitted to copy, print or save any VA information accessed via CAG at any time. VA prohibits remote access to VA’s network from non-North Atlantic Treaty Organization (NATO) countries. The exception to this are countries where VA has approved operations established (e.g. Philippines and South Korea). Exceptions are determined by the COR in coordination with the Information Security Officer (ISO) and Privacy Officer (PO).

The Contractor shall utilize government-provided software development and test accounts, document and requirements repositories, etc. as required for the development, storage, maintenance and delivery of products within the scope of this effort. The Contractor shall not transmit, store or otherwise maintain sensitive data or products in Contractor systems (or media) within the VA firewall IAW VA Handbook 6500.6 dated March 12, 2010. All VA sensitive information shall be protected at all times in accordance with VA Handbook 6500, local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this PWS. The Contractor shall ensure all work is performed in countries deemed not to pose a significant security risk. For detailed Security and Privacy Requirements (additional requirements of the contract consolidated into an addendum for easy reference) refer to ADDENDUM A - ADDITIONAL VA REQUIREMENTS, CONSOLIDATED and ADDENDUM B - VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE.

image1.jpeg