Attachment 3 - Performance Work Statement (PWS).pdf

Performance Work Statement

NBAF-Biorisk Management Annual Verification and Commissioning Support.

1.0 Background and Justification:

NBAF is currently evaluating the facility and engineering systems to support registering BSL-3, BSL-3Ag, and BSL-4 laboratories with the Federal Select Agent Program (FSAP). Critical elements in the process to establish this designation are the development of a plan to evaluate and ensure the reliable operation of critical assets that support building operation and use. To operate more efficiently, optimize maintenance activities, and improve asset reliability, NBAF is implementing a contract to support and evaluate containment engineering systems. The contractor will work with NBAF’s Biorisk Management (BRM) Unit and the Facilities Operations and Maintenance Unit (FOMU) to provide technical expertise as indicated in the statement of work.

2.0 Project Situation:

2.1 NBAF has received a commissioning report from DHS and concluded that numerous outstanding facility and engineering system issues need to be addressed.

2.2 Commissioning HVAC verification testing results does not conclusively provide acceptable evidence that engineering systems function appropriately to achieve successful results for federal regulatory review.

2.3 NBAF will be expected to compile the information required to fulfil BSL-3/BSL-3Ag/BSL-4 Verification Requirements as prescribed by the Federal Select Agent Program (FSAP), which will likely include engineering efforts to evaluate and resolve conditions that impact containment functionality.

2.4 Containment engineering support is required to assist NBAF with evaluating existing operating conditions of the laboratories to, collaboratively with BRM and FOMU, develop an action plan to comply with FSAP regulatory requirements, local regulatory requirements, and necessary biocontainment operation’s needs.

3.0 Scope of Work:

The Contractor in the role of Senior Biocontainment Subject Matter Expert, will guide NBAF Leadership on the regulatory compliance needs for registration with the FSAP and other operational needs (400 hours per year) will work under the direct supervision of the NBAF director and will specifically abide by the following scope of work to support the facility requirements for select agent registration and ongoing biocontainment operations.

3.1 The Contractor shall work with and support the BRM Unit to assess the existing conditions of biocontainment operations and how they should be addressed to meet select agent registration.

3.2 The Contractor shall support BRM and FOMU (as needed) as subject matter expert and assist the USDA BRM and FOMU with evaluating engineering and containment system performance and identifying action items to support select agent registration.

3.3 The Contractor shall interface with FOMU maintenance personnel and BRM, including the BRM Manager, the Biosafety Officer, the Select Agent Program Manager and NBAF leadership to provide guidance in addressing engineering, maintenance and repair needs to support select agent registration.

3.4 The Contractor shall provide guidance to BRM and FOMU to assess conditions that require major repair activities and capital improvement initiatives and provide recommendations in the prioritization for performing these activities.

3.5 The Contractor shall guide FOMU and BRM to determine how biocontainment systems verification testing needs to be performed to meet acceptance criteria for each BSL and FSAP requirements.

3.6 The Contractor shall serve as a Senior Biocontainment Subject Matter Expert and assist BRM with evaluating engineering and containment system performance, identifying action items and tasks to support regulatory compliance and operational performance.

3.7 The Contractor shall support the BRM unit and FOMU in defining biocontainment performance requirements and verification plans for regulatory compliance and operational intent.

3.8 The Contractor shall provide FOMU and identified BRM staff training on biosafety facility operations, planning, preparation, implementation, and performance for verification testing. This will help drive the development of the O&M policies and procedures. Includes assigning and aligning tasks FOMU will complete to prepare and evaluate systems before conducting planned verification testing. Provide mentorship with FOMU and address personnel perceptions or concerns related to their safety using biosafety risk assessments and best practices.

4.0 Deliverables:

4.1 Monthly activity reports will be produced to support their efforts to perform the abovementioned tasks.

4.2 Quarterly, high-level summary reports would be provided to the NBAF Director on findings, conclusions, and recommendations.

5.0 Contractor Requirements:

5.1 Work Restrictions & Conditions

5.1.1 Site Security Access: Access to the site is controlled by a security fence and visitor/contractor check-in/check-out system. All contractor/subcontractor employees shall sign-in and out at the main entrance gate and always wear a contractor/visitor identification badge while on the site. The ID badges will be turned in at the end of the workday. A current government-issued identification with a picture ID is required for entry.

5.1.2 All persons accessing the site must complete the approximate two hour, NBAF Site Security and Safety Orientation. Site specific biosafety and select agent training is currently being developed. If development is completed during the duration of this contract the training may be required for all persons accessing the site.

5.1.3 Contractor vehicles and employee’s personal vehicles shall be parked in the facilities main parking lot.

5.1.4 Unless accompanied by a USDA employee, the Contractor, subcontractors, and their employees shall not enter buildings or facilities not specifically part of this contract. Reasons included, but are not limited to, disease control and health requirements.

5.1.5 Failure to comply with access requirements shall be adequate grounds for removal of the Contractor/subcontractor employees from the site and barring further site access to individuals.

5.1.6 Work Hours: Regular work hours for the site are 6:00 am to 6:00 pm, Monday through Friday, excluding Government holidays.

5.1.7 Federal Holidays are listed below:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day Juneteenth Independence Day

5.1.8 Work Outside Regular Work Hours: Make application through the COR at least 5 calendar days prior to such work to allow arrangements to be made by the Government for access to the work area and inspection and monitoring arrangements. Requests shall include the exact dates, hours, location, and purpose of the exception. If approved, the COR will coordinate access with the site security office.

5.1.9 Personnel employed by the Contractor or any representative of, or agent of the Contractor, entering this facility shall conform to the facility security regulations. The Contractor shall provide all information required for background checks to meet facility access requirements as performed by the facility security office. Contractor personnel shall comply with all personal identity verification requirements as directed by USDA-ARS Security office. Each person accessing the site will be required to provide personal details, (full name, DOB, SSN, DL#) and will undergo a routine background check, such as a National Agency Check with additional inquiries, which may include a criminal and credit check. Details required for the check should be submitted the security office NLT 5 days prior to the visit. Results of this check may return earlier. However, it should not be planned to have results earlier than 5 days. If, while on site the contractor/vendor will have access to sensitive information, they must complete a National Disclosure Agreement (NDA), along with the required training. This training will most likely be completed by reviewing a series of slides covering the topics of the definition of controlled unclassified information (CUI), access, handling, distribution, storage, and destruction of CUI. Each person will acknowledge receiving and understanding the training on the NDA. The process should not exceed two hours. Acknowledgement and completion of the NDA will be turned in with the form required for the background check. Results will be returned through the Contracting Officer or Contracting Officer Representative. Contractors needs to follow Title 41, Code of Federal Regulations, Part 102-74, Subpart C Rules, and Regulation Governing Conduct on Federal Property.

Additional security requirements may be imposed when the Federal Government raises the Homeland Security Alert Level. Additional directions will be provided if the situation occurs. The Contractor shall safeguard all USDA-ARS equipment, information and property provided for Contractor use. At the close of each work period, USDA-ARS facilities, equipment, and materials shall be secured.

6.0 Contractor Core Competencies:

6.1 Extensive experience operating, maintaining, and designing high and maximum containment facilities (BSL-3, BSL-3Ag, BSL-4).

6.2 Proven expertise in evaluating containment facilities and engineering systems to reliably perform to meet risk-based requirements and FSAP performance requirements.

6.3 Recognized subject matter expert on decontamination, high containment facility construction, operations, commissioning, engineering management, and managing agricultural research facilities.

6.4 Scientific background and expertise in performing biosafety and conditional risk assessments for critical high-risk environments.

6.5 Containment systems engineering expertise in designing, implementing, and performing effluent decontamination systems, BSL-4 breathing air and decontamination systems, and electrical systems.

6.6 Experience designing, commissioning, and managing scientific research facilities that perform work with Tier 1 select agents such as foot and mouth disease virus.

7.0 Government Furnished:

7.1 The Government will furnish desk space with typical office space amenities.

8.0 Travel:

8.1 The Contractor is expected to provide a maximum of twelve (12) site visits to NBAF throughout the period of performance.

Each trip will allow at least two consecutive days to meet task deliverables. All travel requests for the execution of tasks must be submitted, in writing, to the NBAF Director no less than ten (10) business days in advance of the travel event. All travel and other direct costs associated with travel shall be within Federal Travel Regulations.

9.0 Period of Performance:

9.1 The period of performance of this contract shall consist of a one-year base period plus a one-year option period. Continued funding is contingent upon an acceptable level of performance.

10.0 Payment Schedule

10.1 CLIN 1: Itemized monthly travel expenses.

10.1.1 Limited to twelve (12) site visits to NBAF throughout the period of performance.

10.1.1.1 Contractor must provide appropriate supporting documentation and any additional justification documentation if requested.

10.2 CLIN 2: Itemized monthly billing in Hourly Units as a Senior Biocontainment Subject Matter Expert.

10.2.1 This contract has a maximum of 400 billable hours per year.

10.2.1.1 On the Service Schedule: 400 will be the quantity ordered, hours will be the units and unit price will be the total bid under this CLIN divided by four hundred (400).

11.0 Place of Performance

11.1 REMOTE:

11.1.1 Via MS TEAMS

11.1.2 Zoom

11.2 National Bio and Agro-Defense Facility 1980 Denison Ave., Manhattan, KS 66502