Attachment 2 PWS.pdf

Performance Work Statement (PWS) Project: BIOLOGICAL SAFETY

CABINETS CERTIFICATION (NBAF)

PART 1

GENERAL INFORMATION: Performance work statement for certification, maintenance, and repair of laminar air flow biological safety cabinets (BSC), Type A2 Class II BSC’s, Type B2 Class II BSC’s, Class III BSC’s, laminar flow hood, HEPA filtered animal bedding dump station, mobile animal transfer stations, rodent racks, HEPA intake and exhaust pass-through, HEPA intake only pass-through, Class II walk in enclosure, window space units exhaust HEPA filter and ventilated rabbit racks for the National Bio and Agro-Defense Facility (NBAF) for the base period and four (4) option periods.

1.0 Definitions: USDA - United States Department of Agriculture

ARS - Agricultural Research Services

1.1 Period of Performance: The period of performance (POP) shall be for one (1) Base Period and four (4) option periods. The POP reads as follows:

Base Period: 15 June 2022 to 14 June 2023

Option Period 1 15 June 2023 to 14 June 2024

Option Period 2 15 June 2024 to 14 June 2025

Option Period 3 15 June 2025 to 14 June 2026

Option Period 4 15 June 2026 to 14 June 2027

1.2 Background and Purpose: The National Bio and Agro-Defense Facility (NBAF) campus located at 1980 Denison Avenue, Manhattan, Kansas has the need for certification, maintenance, and repair of laminar air flow and other HEPA filtered devices including:

Class II biological safety cabinets (BSC) Type A2, Type B2 Class III BSC’s, laminar flow cabinet, HEPA filtered animal bedding dump station, mobile animal transfer stations, rodent racks, HEPA intake and exhaust pass-through, HEPA intake only pass-through, Class II walk in enclosure, window space units exhaust HEPA filter, and ventilated rabbit racks which includes approximately 183 total units. A current list of units is located in Attachment 1.

1.3 Qualifications: The certifying engineer/technician performing work under this contract shall in support of the ARS’ ISO 17025 Accreditation Plan, only an individual who possesses a current accreditation by the National Sanitation Foundation (NSF) on NSF/ANSI Standard 49 Class II (Laminar Flow) Biosafety Cabinetry can be the certifier to calibrate and make repairs to these BSC’s. A copy of the individual’s NSF Accreditation Certificate must be submitted to contracting officer’s representative prior to the individual coming on-site.

1.4 Security Requirements: 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, 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.

1.5 Physical Security: The certifying engineer/technician performing work under this contract 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.

1.6 General Work Performance Location & Hours: The work shall be scheduled during normal business hours of the NBAF between 8:00 am and 4:00 pm local time; Monday – Friday. Work completed after hours or on weekends and/or holidays will be proposed at least a week in advance of the requested work time and may be approved by the NBAF Chief Facility Engineer/Contracting Officer’s Representative.

1.7 Federal Observed Holidays:

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

1.8 Quality Control Program (QCP): The Contractor shall develop, implement, and maintain an effective QCP to ensure services are performed in accordance with industry standards and this PWS. The QCP, including changes, shall be forwarded to and accepted by the Contracting Officer (CO). The Contractor shall develop and implement procedures to identify, remedy, and prevent future deficiencies and shall review the plan with his onsite personnel to ensure complete understanding. The Contractor’s Quality Control Program is the means by which the Contractor assures that the work complies with the requirement of the contract. The QCP must be provided within 30 days of the notice to proceed and shall be kept current, reflecting the pertinent contract modifications and building changes or conditions, with updates being submitted within five (5) days of changes being made.

1.9 Contractor Performance Assessments: The Contractor will evaluate his contract services, correcting any deficiencies, which deviate from the commercially acceptable standard for HEPA certification. The Contractor shall furnish a copy of the evaluation/inspection reports to the designated COR for this contract as requested.

1.9.1 The name of the Project Manager

1.9.2 A communication plan that shall describe methods of direct and indirect communication with USDA-ARS regarding performance of the contract.

1.9.3 The Contractor shall give immediate written notice to the CO or COR of any condition which is discovered that may present a hazard to either the operational mission or staff.

1.9.4 The method(s) for identifying and preventing defects in the quality of service performed before the level of performance becomes unacceptable.

1.9.5 On site records of all inspections conducted by the Contractor and necessary corrective action taken. This documentation shall be made available to the CO and/or COR during the term of the contract.

1.10 USDA-ARS Performance Assessments: USDA-ARS performance assessments will be assigned to and authorized by the COR. The COR will evaluate the contractor's performance under this contract IAW the Quality Assurance Surveillance Plan (QASP).

This plan is primarily focused on what USDA-ARS must do to ensure that the contractor has performed IAW the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

Although USDA-ARS may develop a Quality Assurance Surveillance Plan, USDA-ARS surveillance of Contractor performance is not limited to the QASP or the performance objectives, incentives/remedies, etc. USDA-ARS has the right to inspect and test all services called for by the contract and commitments made by the Contractor during the solicitation process, to the extent practicable at all places and times during the term of the contract. USDA-ARS will perform inspections and tests in a manner that will not unduly delay the work. If any of the services performed do not conform to contract requirements, USDA-ARS may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, USDA-ARS may: (1) require the Contractor to take necessary action to ensure that future performance conforms to contract requirements, and (2) reduce the contract price to reflect the reduced value of the services performed. If the Contractor fails to promptly perform the services again or take the action necessary to ensure future performance in conformity with contract requirements, USDA-ARS may: (1) by contract or otherwise, perform the services and charge to the Contractor any cost incurred by USDA-ARS that is directly related to the performance of such service, or (2) terminate the contract for default. "Services", as used in this clause, includes services performed, workmanship, and material furnished or used in performing services.

1.10.1 USDA-ARS personnel will accompany Contractor personnel during regular maintenance, service calls, or other work visits to observe and or ask for explanation of work performed. The intent is to inspect the work and not to delay the Contractor in any way.

1.10.1.1 Performing quality assurance in accordance with the PWS does not preclude USDA-ARS from conducting inspections as defined in Federal

Acquisition Regulation (FAR) 52.212-4 Contract Terms and Conditions for Commercial Items for Inspection/Acceptance.

1.10.1.2 If performance or quality measures are not being met by the Contractor, USDA-ARS will revisit the QCP and may request revisions. Upon review of the plan and related documents, USDA-ARS will take appropriate action to ensure that all quality and performance measures are met as specified in this contract.

1.10.1.3 Type of Contract: USDA-ARS will award a performance-based commercial services contract. This means that USDA-ARS has described WHAT is to be accomplished, not HOW to accomplish it, and states a basis for determining whether finished work meets USDA-ARS quality requirements. It does not state detailed procedures for accomplishing the requirement unless there are safety, security, or communication requirements. It is the intent of USDA-ARS to provide the Contractor the maximum amount of flexibility to propose an innovative approach, and to find the most efficient and cost-effective method for meeting the stated objectives and requirements.

1.10.1.4 Post Award Conference / Performance Evaluation Meetings: The

Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO and COR shall have performance evaluation meetings with the Contractor to review the Contractor's performance as needed. At these meetings the CO will apprise the Contractor of how the Government views the Contractor's performance and the Contractor will apprise USDA-ARS of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. Meetings may be held at any time thereafter as determined beneficial by USDA-ARS and Contractor.

1.10.1.5 Contracting Officer’s Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: Assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, and specifications; monitor Contractor's performance and notifies both the CO and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.11 Personnel:

1.11.1 Contractor Key Personnel: The Contractor shall provide a contract manager who shall be responsible for the performance of the work and shall be the central point of contact with the Government. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available from 8:00 a.m. to 4:00 p.m., Monday through Friday except Federal holidays or when the USDA-ARS facility is closed for administrative reasons.

1.11.2 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are USDA/Government officials. They must also ensure that all documents or reports produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.11.3 Rosters: For NBAF Facility security purposes, the Contractor shall provide the

CO a list of all employees who will perform work under this contract. The list shall include name and work assignment of each employee. The Contractor shall maintain revisions and updates to this list and submit them to the COR monthly.

1.11.4 Employee Badges: The Contractor shall furnish each employee a contract identification badge that shall be conspicuously displayed when working. The ID badge shall include the full name of the employee, company name, a badge serial number

1.11.5 Contractor Personnel Conduct: The CO may require the contractor to remove any employee(s) from the contract and worksite for nonperformance, misconduct, or failure to abide by all laws and regulations. The contractor shall immediately comply with these requests. The following is a not an all-inclusive list of specific conduct NOT be condoned:

1. There shall be no fraternization or interference with the work of employees at the NBAF.

2. There shall be no violation of the GSA Publication; Rules and Regulations Governing

Conduct on Federal Property (Federal Management Regulation Title 41, Code of Federal Regulations, Part 102-74, Sub-Part C, November 2005) found at the following internet link:

http://www.gsa.gov/graphics/ogp/Fed_Rules_Regs8_5x11_Final2005_R27-s10_0Z5RDZ-i34K-pR.pdf

3. Neglect of Duties - includes sleeping on duty, failure to be attentive to assigned duties, failure to carry out assigned tasks, conducting personal business during duty hours.

4. Disorderly Conduct - e.g., the use of abusive or offensive language, quarreling, intimidation by words, actions, fighting, or participation in disruptive activities which interfere with normal and efficient operations of the NBAF or any organization or function on the NBAF Campus.

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5. Criminal Actions - e.g., falsification or unlawful concealment, removal, mutilation, or destruction of any official documents, reports, or records, unauthorized use of Government property, theft, vandalism, immoral conduct, organizing or participating in gambling of any form, unethical, improper, or fraudulent use of official authority or identification, the unauthorized, improper, or fraudulent use of communications equipment.

6. Release of Information - all contractor employees shall be prohibited from releasing any information pertaining to duty assignments, manpower, personnel, or other information to any outside organization or person(s), without the explicit, written consent of the CO or COR.

7. Violations of Security Procedures or Regulations - includes violations of established security procedures, policies, regulations, or guidelines, as well as failure to report to appropriate security officials any unauthorized security activity, observed or otherwise known to have occurred, or which is about to occur, on or which could affect USDA, APHIS, ARS, any specific organization or mission within USDA, or the security posture of the NBAF.

Contractor personnel’s conduct shall not reflect discredit upon USDA-ARS. The Contractor shall ensure that personnel present a professional appearance. The Contractor’s employees shall observe and comply with all local policies and procedures concerning fire, safety, environmental protection, sanitation, security, and possession of firearms or other lethal or illegal weapons or substance. The Contractor is responsible for ensuring that any contractor employees providing services under this contract conduct themselves and perform services in a professional, safe, and responsible manner. The Contractor shall remove from the job site any employee for reasons of misconduct or security. Particular attention should be paid to acceptance of gifts/ gratuities, and on non-disclosure of sensitive or classified information. The Contractor shall ensure employee conduct complies with 41 USC 423 relative to release of acquisition related information, or actions or discussions which may prejudice future competitions. The Contractor shall ensure no contractor employees conduct political related activities or events on the Installation.

PART 2

CONTRACTOR FURNISHED ITEMS AND SERVICES

2.0 CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES: The

Contractor shall furnish all equipment, materials, supplies, services required to achieve the quality performance standards of the work in this contract, unless otherwise specified herein.

PART 3

3.0 GOVERNMENT FURNISHED EQUIPMENT:

3.1 Filters and repair parts are to be purchased by the NBAF

3.2 All HEPA filters and MERV pre-filters

PART 4

SPECIFIC TASKS

4.0 SPECIFIC TASKS:

4.1 Provide a Plan: The contractor shall provide a plan for certification of HEPA filtered equipment, identified in Attachment 1, that aligns with recognized standards and guidance. The plan shall include the use of but not limited to IEST-RP- CC-0034. This Recommended Practice (RP) also includes procedures for measuring the uniformity of the aerosol challenge approaching the filter under test.

4.2 Field Services: The contractor shall perform work in accordance with

NSF/ANSI Standard 49 Class II (Laminar Flow) Biosafety Cabinetry, Annex F – Field Tests. The Class I cabinets, Class III cabinets, HEPA filtered small animal isolators must be certified according to manufacturer specifications/recommendations.

The following physical certification tests are the minimum required tests to be performed for BSCs:

4.2.1 Downflow Velocity

4.2.2 Inflow Velocity

4.2.3 HEPA Filter Leak Test (both supply and exhaust)

4.2.4 Airflow Smoke Pattern Tests

4.2.4.1 Downflow Test

4.2.4.2 View Screen Retention Test

4.2.4.3 Work Opening Edge Retention Test

4.2.4.4 Sash/Window Seal Test

4.2.5 Alarm Calibration

4.2.6 Cabinet airflow stability

4.2.7 Canopy connection test – where applicable

4.2.8 Pressure decay test – where applicable

4.2.9 Site Assessment of Installation

Certification and repairs will be performed in accordance with NSF/ANSI Standard 49 Class II (Laminar Flow) Biosafety Cabinetry, Annex F – Field Tests or according to manufacturer specifications/recommendations.

All signed certification reports must be turned in to the NBAF Biosafety Office within a week after the cabinet has been completed. Certification stickers must be posted on all cabinets. Certification stickers must display at least the following information: company name providing the certification, serial number of the BSC, standard or specification that the BSC was tested to, date certification testing was performed, duration of certification period and the signature of the person performing the certification.

• Any BSC that fails certification will be labeled “Cabinet Uncertified:

Do Not Use” by the certifier until repairs and recertification or decommissioning has taken place

For laminar air flow biological safety cabinets (BSC), class II BSC’s, class III BSC’s, HEPA filtered animal bedding dump stations, mobile animal transfer stations, rodent racks, and rabbit cages failing certification, part numbers for required repair parts must be submitted to the NBAF Biosafety Office within 10 business days following the site visit.

• Labor for filter replacement and repairs to BSCs and other HEPA filtered equipment required to meet NSF/manufacturer specifications is included in the contract.

• "Certification and repairs will be performed in accordance with NSF/ANSI Standard 49 Class II (Laminar Flow) Biosafety Cabinetry, Annex F - Field Tests or according to manufacturer specifications/recommendations."

• NBAF will order the replacement parts and have them available for installation at a regularly scheduled visit or an emergency visit if the program requires it. Or if the cost and age of the device no longer warrants continued service then NBAF will direct the certifier to decommission it and remove it from service.

4.3 Provide documentation of certification: The contractor shall supply all certification documentation for review in an electronic format.

4.4 Provide a Standard Operating Procedure: The contractor shall provide a Standard Operating Procedure (SOP) sequentially listing all tasks in the certification process designed to enable NBAF biosafety technicians to successfully conduct follow-on certifications in a manner that conforms to accepted standards and guidance.

4.5 NBAF Biosafety Technicians shadowing: During maintenance and certification period at NBAF, the contractor shall allow up to three BRM Biosafety Technicians to shadow on the certification process at NBAF at no cost to the government. Shadowing of contractor(s) shall not impede on the production or work but shall provide visualization of the process. BRM biosafety technicians will assist the contractor in the certification process as able but must be allowed to view the process in its entirety.

PART 5

5.0 DELIVERABLES SCHEDULE:

5.1 The contractor shall provide a schedule for the completion of work within 30 days of the being awarded the contract.

5.2 The contractor shall provide a Standard Operating Procedure within 120 days.

5.3 The contractor shall provide a weekly update of the work completed to the COR by the close of business on the first workday of the following work week.

5.4 The contractor shall provide a copy of the individual’s NSF Accreditation

Certificate to the Contracting Officer or Contracting Officer Representative prior to the individual coming on-site.

5.5 The contractor shall post certification stickers on the cabinets and signed certification reports must be turned in to the COR within a week after the cabinet has been completed.

5.6 NBAF reserves the right to mandate the order the BSC’s are certified to meet stockholder requirements.

5.7 All required certifications for the base period of this contract shall be completed no later than 1 October 2022.

5.8 All required certifications for the option periods will start 1 February and shall be completed no later than 1 October.