Attachment 1 - PWS.pdf

United States Department of Agriculture Agricultural Research Service

PERFORMANCE WORK STATEMENT

PROJECT: LYOPHILIZER EVALUATION

National Bio and Agro-Defense Facility USDA-ARS, Manhattan, KS

Contents

1. PURPOSE

2. MISSION AND BACKGROUND

3. PERIOD AND LOCATION OF PERFORMANCE

4. CONTRACTOR PERSONNEL

5. GOVERNMENT PERSONNEL

6. PERFORMANCE REQUIREMENTS

7. OPERATING CONTRAINTS AND ANY ADDITIONAL REQUIREMENTS

8. QUALITY ASSURANCE SURVEILLANCE PLAN

1. PURPOSE

This Performance Work Statement for Lyophilizer Evaluation will describe the work in terms of the required results and enable assessment of work performance against measurable performance standards.

The lyophilizer is already purchased, installed, and will be operated by government employees that are all located at the National Bio and Agro-Defense Facility (NBAF) at 1980 Denison Ave, Manhattan, KS 66502.

Acronyms Summary:

ARS: Agricultural Research Services BDM: Biological Development Module CO: Contracting Officer COR: Contracting Officer’s Representative CUI: Controlled Unclassified Information FAR: Federal Acquisition Regulation ISO: International Organization for Standardization NBAF: National Bio and Agro-Defense Facility NDA: Non-Disclosure Agreement POP: Period of Performance PRS: Performance Requirements Summary PWS: Performance Work Statement QA: Quality Assurance QASP: Quality Assurance Surveillance Plan USDA: United States Department of Agriculture

2. MISSION AND BACKGROUND

The NBAF provides and strengthens the nation with critical capabilities to diagnose animal diseases, to conduct research and develop vaccines and other countermeasures, and to train veterinarians and other scientists in preparedness and response to disease outbreaks. NBAF’s mission is to protect the United States against transboundary, emerging, and zoonotic animal diseases that threaten our food supply, agricultural economy, and public health. NBAF’s vision is to create a safer and more resilient America through a world-class science facility for large animal agricultural research, training, and diagnostics.

The mission of the Biologics Development Module (BDM) within the NBAF is to directly support and accelerate technology transfer of vaccines, diagnostics, biotherapeutics, and other veterinary medical countermeasures for development to commercial veterinary biologic manufacturers and other partners.

BDM efforts include, but are not limited to, the production of attenuated viral and bacterial master seeds, master cells for viral vaccine production, monoclonal antibodies, small scale viral and bacterial (attenuated or inactivated) vaccines, recombinant proteins, and diagnostic reagents. The BDM also provides dedicated space for formulation manufacture of experimental products for clinical studies, support the early development of veterinary medical countermeasures, implementation of quality assurance and quality control measures, and support the technology transfer to potential future commercial manufacturers. It is through these efforts and provisions, that the BDM envisions putting impactful biologics solutions into the hands of farmers, producers, and veterinarians through a focus on quality and collaboration with cutting-edge science institutions and biologics manufacturers.

3. SCOPE

To accomplish this mission and vision the BDM will need to service the large capacity Lyophilizer within the certified cleanroom to carry out freeze-drying processes. Freeze-drying is the preferred method for stabilizing live, attenuated virus vaccines. There are many challenges to the complex process of freeze-drying, and it is critical to have a properly validated and maintained Lyophilizer to avoid any additional challenges. It is also crucial that the personnel utilizing the freeze-dryer are well-trained and informed on the mechanisms to increase success in freeze-drying and formulation/process development.

The Lyophilizer that was installed into the BDM is a Millrock Technology Quanta Series Freeze-Dryer Model PDQ50ISS01. The installation was subcontracted out to Haldeman Homme who was certified in 2020. The BDM has identified the need to have this freeze-dryer operational, validated, and maintained.

The BDM staff will also need to be trained on the general preventative maintenance and operational functions required for the Quanta Series Freeze-Dryer.

However, this need cannot be met until the freeze-dryer is evaluated and an initial inspection and assessment is performed. The BDM will need to understand what repairs, parts, and services are needed before establishing a more in-depth contract.

4. PERIOD AND LOCATION OF PERFORMANCE

The base period of performance (POP) must be for one (1) Base Year of 12 months.

The work must be scheduled during normal business hours of the NBAF between 7:00 am and 5:00 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 coordinated and reviewed in conjunction with the Contracting Officer/Contracting Officer’s Representative.

Federally Observed Holidays:

New Year’s Day Martin Luther King’s Birthday Washington’s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans’ Day Thanksgiving Day Christmas Day

5. CONTRACTOR PERSONNEL

Qualifications:

The contractor must provide written or electronic documentation showing the specialists performing work under this PWS are individuals that have certified training and/or documented experience with this particular type of freeze-dryer. The contractor must provide proof of familiarity that qualifies the specialist to perform the evaluation and understanding of ISO 14644-1:2015 Cleanrooms and associated controlled environments is preferred.

Identification:

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.

For NBAF Facility security purposes, the contractor must provide the CO a list of all employees who will perform work under this contract. The list must include name and work assignment of each employee.

The contractor must maintain revisions and updates to this list and submit them to the COR monthly as needed. The contractor must furnish each employee a contract identification badge that must be conspicuously displayed when working. The ID badge must include the full name of the employee, company name, a badge serial number.

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 must immediately comply with these requests. The following is not an all-inclusive list of conduct expectations:

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

2. There must 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).

3. Contractor personnel’s conduct must not reflect discredit upon USDA-ARS.

4. The contractor must ensure that personnel present a professional appearance.

5. The contractor’s employees must observe and comply with all NBAF and 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 or subcontractor providing services under this contract conduct themselves and perform services in a professional, safe, and responsible manner.

6. The contractor must remove from the job site any employee or subcontractor for reasons of misconduct or security.

7. 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.

8. 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.

9. 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.

10. Release of Information - all contractor employees must 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.

11. 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.

12. Particular attention should be paid to acceptance of gifts/ gratuities, and on non-disclosure of sensitive or classified information.

13. The contractor must ensure employee or subcontractor conduct complies with 41 USC 423 relative to release of acquisition related information, or actions or discussions which may prejudice future competitions.

14. The contractor must ensure no contractor employees conduct political related activities or events on the Installation.

Furnished Items and Responsibilities:

The contractor must furnish all personnel, equipment, materials, supplies, services, and shipping costs required to achieve the performance requirements of the work in this contract, unless otherwise specified herein. The certifying engineer/technician performing work under this contract must 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 must be secured.

The contractor must provide a plan for the completion of the work outlined in this PWS and submit to the COR at a minimum of seven days (7) prior the start of work.

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 must 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 must be taken to resolve outstanding issues. Meetings may be held at any time thereafter.

Travel Travel will be on a short-term basis and arranged in accordance with Federal Travel Regulations (FTR).

Travel must be approved in writing by the COR [prior to travel]. Approved travel required during the performance of the contract will be reimbursed. Contractor costs incurred for travel will be considered reasonable and allowable only to the extent they do not exceed the daily maximum per diem rates in effect at the time of travel as set forth in the FTR. Costs incurred for transportation and per diem (lodging, meals and incidental expenses) shall be billed in accordance with the regulatory implementation of FAR 31.205- 46 Travel Costs. The Government shall not be charged G&A fees for any travel. Contractors shall be reimbursed only for incurred costs at or below the “not to exceed” amount specified in the contract.

All travel in connection with the work to be performed under this Contract shall be identified as a separate cost on the invoices submitted. The Contractor shall be reimbursed for such travel as follows:

• Commercial Carriers: As outlined in Federal Travel Regulations (current commercial coach or tourist rate)

• Taxi: As outlined in Federal Travel Regulations

• Automobile: As outlined in Federal Travel Regulations

• Commercial: As outlined in Federal Travel Regulations

• Private: As outlined in Federal Travel Regulations

• Subsistence: As outlined in Federal Travel Regulations

The Contractor shall submit itemized travel detail with the invoice and associated receipts for airfare, lodging, rental car, parking, and other costs more than $25.

6. GOVERNMENT PERSONNEL

Provisions:

1. The government must provide access to the spaces where the lyophilizer is located.

2. The government will provide documentation to confirm that the laboratory spaces have not been exposed to biological hazards or have been properly decontaminated and do not pose human exposure risk.

3. The government will provide escorts for necessary contractor personnel when onsite.

4. The government will provide training onsite for emergency procedures such as weather, fire, and any necessary biosafety practices that must be adhered to, as needed.

5. The government will communicate any additional equipment information/changes as required by the vendor during the contract.

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.

7. PERFORMANCE REQUIREMENTS

1. All services must meet all Local, State and Federal codes.

2. The contractor will provide a general overview of the capacities of this particular model of freeze-dryer, and any recommended best practices.

3. The contractor will provide an initial inspection and assessment of the lyophilizer that includes the following items:

Visual Inspection: Exterior and interior condition check, and ensure all connections are intact and functional.

Functional Testing: Power on/off, check functionality of control panel, and ensure a basic operational cycle can be selected.

Mechanical and Electrical Systems: Inspect and test motors, compressors, pumps, valves, sensors and thermostats to determine operational status.

Refrigeration System: Check the cooling coils and condenser and look for any deficiencies or problems.

Vacuum System: Check vacuum system and look for any deficiencies and problems.

Safety Check: Verify all safety mechanisms possible and ensure equipment can comply with relevant safety standards and regulations.

Documentation Review: Review available manuals, schematics, and other documentation as well as existing maintenance records for past issues and repairs.

Operator Training Needs: Identify possible training needs for current and future operators.

4. The contractor will provide an estimated cost for getting the lyophilizer operational, validated, maintained over a period of year, and personnel trained on general functionality and safety requirements.

8. OPERATING CONTRAINTS AND ANY ADDITIONAL REQUIREMENTS

Security Requirements:

Personnel employed by the contractor or any representative of, or agent of the contractor, entering this facility must conform to the facility security regulations. The contractor must provide all information required for background checks to meet facility access requirements as performed by the facility security office. Contractor personnel must 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 no later than 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 Non- 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.

The contractor and/or any representative of, or agent of the contractor, entering this facility must conform to the visitor and escorting policies. All visitors must display appropriate badge and/or other identifying credentials. All visitor(s) have their government issued photo I.D. or equivalent, in addition to, NBAF issued visitor badge available for upon request by security personnel while on the NBAF. Visitors must sign applicable visitor log upon entrance and exit and stay with the escort at all times. The contractor and/or any representative of, or agent of the contractor must not take photography of the interior or exterior of the NBAF from within the NBAF property. The contractor and/or any representative of, or agent of the contractor, entering this facility must comply with all USDA and NBAF procedures and/or policies (e.g., Rules and Regulations Governing Conduct on Federal Property Title 41 CFR Part 102) and submit to searches by security personnel of their person, personal effects, and vehicles as per 41 CFR 102-74.370.

9. QUALITY ASSURANCE SURVEILLANCE PLAN

This Quality Assurance Surveillance Plan (QASP) is a government developed and applied document used to provide a standard of surveillance for monitoring the Lyophilizer evaluation contract.

This QASP establishes the approach the government will use to conduct surveillance of the contractor’s quality control. The intent is to ensure that the contractor performs in accordance with performance requirements set forth in the contract documents, that the government receives the quality of services called for in the contract, and that the government only pays for the acceptable level of services received.

The contractor is responsible for management and quality control actions to meet the terms of the contract.

The role of the government’s quality assurance (QA) representative (BDM Quality Specialist) is to ensure the contractor performs quality control to adequately meet contract standards. USDA-ARS performance assessments will be assigned to and authorized by the COR. The COR will evaluate the contractor's performance under the Quality Assurance Surveillance Plan (QASP).

From the start of the contract, all contractor operational procedures and quality assurance measures will be tested and implemented. As the performance period progresses, the levels of surveillance may be altered for service areas in cases where performance is either consistently excellent or consistently unsatisfactory.

If observations reveal consistently good performance, then the amount of surveillance may be reduced. If observations reveal consistent deficiencies, increased surveillance may be implemented.

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 conform 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.

The contractor’s routine performance is evaluated objectively against the performance-based standards provided in the PWS. The basis of performance-based contracting allows for some flexibility in enforcement to encourage innovation by the contractor in achieving the desired results. The government has the right to inspect and test all services called for in the contract. When services are deficient and cannot be re-performed satisfactorily by the contractor, the government will refer to the Inspection of Services clause for remediation.

Methods of Inspection:

The below listed methods of surveillance may be used in the administration of this QASP. They can occur quarterly, monthly, or as needed:

1. 100% Inspection

a. The COR may conduct 100% inspections of the work defined in the PWS. The COR will also review information submitted in the required reports defined in the PWS (if applicable).

2. Periodic Inspection

a. The government may conduct periodic inspections monthly, quarterly, or on an as-needed basis. The periodic inspection shall be conducted by the COR.

3. Random Inspection

a. The government may conduct random monitoring by reviewing information/reports required and submitted in accordance with the contract. The random monitoring shall be performed by the COR.

4. Performance Evaluation Meetings

a. The contractor and the COR will meet as often as necessary to review the contractor’s performance and address any discrepancies that have been noted during the period of performance. A mutual effort will be made to resolve identified issues.

5. Personnel Feedback

a. The COR may provide and collect BDM personnel surveys or complaints regarding performance. A mutual effort will be made to resolve any problems/issues identified.

Level of surveillance may be conducted on a monthly, quarterly, or as-needed basis and an analysis of the results will determine if the contractor met the standards or did not met the standards identified in the PWS/contract.

Performance Requirements Summary (PRS):

Performance Objective Acceptable Quality Level Method of Inspection

All services must meet all Local, State and Federal codes.

0 Local, State and Federal codes broken during the period of performance and utilized option years.

100% Inspection

The contractor will provide a general overview of the capacities of this particular model of freeze-dryer, and any recommended best practices.

A document is provided that contains general information about the capacities of this particular model of freeze-dryer, any limitations, recommendations, and opportunities will be detailed out.

Periodic Inspection

The contractor will provide an initial inspection and assessment of the lyophilizer and any associated software. 1.

A full inspection and assessment is performed that details out the provided items, and any additional recommendations the contractor might have. A detailed report should be provided of all inspection findings, including recommended actions.

The goal of this report will be to ensure operational status action items can be met moving forward.

The contractor will provide an estimated cost for getting the lyophilizer operational, validated, maintained over a period of year, and personnel trained on general functionality and safety requirements.

An organized and thorough cost estimate/analysis will be provided that includes estimated costs for maintenance, parts (including part numbers), and services. As well as future needs such as validation, training, and continued maintenance through an identified service contract.

The contractor agrees to discuss any issues or actions that need improvement with the government and provide feedback or improvements as needed.

Communications are kept open and honest between the COR, CO, and contractor.

Regular meetings are held depending on the nature and requirements of the contract.

Meeting requirements and frequency will be defined by the COR in coordination with the contractor within 30 days of awarding the contract.

An initial virtual meeting is expected to determine scheduling, as well 2—3 scheduled in-person visits that could vary in length depending on lyophilizer operational requirements.

Performance Evaluation Meetings

Effective contract surveillance relies on the COR identifying and documenting discrepancies during performance of routine daily services, or through the period of performance of the contract. The COR will report discrepancies to the contractor for timely resolution. Surveillance may consist of periodic reports, and customer feedback and timeliness of contract deliverables/reports. The COR will maintain a complete QA file which will be retained by the COR for the life of the contract. Information in the QA file will be considered when completing the annual CPARS report.