Attachment 001 Performance Work Statement Device Calibration Service.pdf

United States Department of Agriculture Agricultural Research Service

Performance Work Statement

PALL Biotech AquaWit IV Annual Calibration

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

Contents

PART 1

GENERAL INFORMATION

Background and Purpose

Definitions

Period of Performance

The base period of performance (POP) shall be for one (1) Base Year of 12 months and four (4) Option Years of 12 months

Qualifications

Security Requirements

Physical Security

General Work Performance Location & Hours

Federal Observed Holidays

Quality Control Program (QCP)

Contractor Performance Assessments

USDA-ARS Performance Assessments

Personnel

PART 2

CONTRACTOR FURNISHED ITEMS AND SERVICES

2.1 Contractor Furnished Items and Responsibilities

PART 3

GOVERNMENT FURNISHED ITEMS

3.1 Government Furnished Items

PART 4

SPECIFIC TASKS

4.1 General Project Requirements

4.2 Bid Schedule

4.3 Plan

4.4 Plan Implementation

PART 5

DELIVERABLES SCHEDULE

Performance Work Statement

AquaWit IV Annual Calibration

PART 1

GENERAL INFORMATION

Performance Work Statement for the Pall Biotech AquaWit IV annual calibration. This unit is government owned and located at the National Bio and Agro-Defense Facility (NBAF) in

Manhattan, Kansas.

Background and Purpose

The National Bio and Agro-Defense Facility (NBAF) located at 1980 Denison Avenue, Manhattan, Kansas, is a state-of-the-art biocontainment facility that is designed to support research and diagnostic activities for the purpose of protecting our nation from emerging and foreign animal disease threats. The facility maintains one (1) AquaWit IV Filter Integrity

Test System that has fully automated test preparation and integrity test cycle for hydrophobic filters.

NBAF has identified the need to validate the operational performance of the AquaWit IV

Filter Integrity Test System by completing the annual calibration of this instrument.

Definitions

ARS: Agricultural Research Services

CLIN: Contract Line-Item Numbers

CO: Contracting Officer

COR: Contracting Officer’s Representative

CUI: Controlled Unclassified Information

NBAF: National Bio and Agro-Defense Facility is a USDA owned facility

POP: Period of Performance

TE-1: Technical Exhibit - 1

QCP: Quality Control Program

USDA: United States Department of Agriculture

Period of Performance

The base period of performance (POP) shall be for one (1) Base Year of 12 months and four (4) Option Years of 12 months.

The POP reads as follows:

CLIN Option Begin End

0001 Base 5/1/2023 4/29/2024

0002 Option 1 4/30/2024 4/29/2025

0003 Option 2 4/30/2025 4/29/2026

0004 Option 3 4/30/2026 4/29/2027

0005 Option 4 4/30/2027 4/29/2028

Qualifications

The contractor shall provide written documentation showing the specialist performing work under this performance work statement (PWS) are individuals that have certified training and documented experience in the annual calibration and recertification of the AquaWit IV.

This documentation shall be provided in the submittal package for review and acceptance.

The contractor must provide proof of training that qualifies the specialist to perform the procedures according to an ISO 9000 of similar quality standard. The contractor must have authorized access to Pall Biotech proprietary software to make modifications to the software, to provide the calibration and recertification service.

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 no less then 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.

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.

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 coordinated and reviewed in conjunction with by the NBAF Chief Facility

Engineer/Contracting Officer’s Representative.

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

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 submit to the Contracting Officer’s Representative (COR) for approval. The contractor 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.

Contractor Performance Assessments

The Contractor will evaluate his contract services, correcting any deficiencies, which deviate from the commercially acceptable standard for the work under this contract. The

Contractor shall furnish a copy of the evaluation/inspection reports to the designated COR for this contract as requested.

1.10.1 The name of the Project Manager

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

1.10.3 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.

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

1.10.5 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.

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 in accordance with the

Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what

USDA-ARS must do to ensure that the contractor has performed in accordance with 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.

1.11.1 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.

1.11.2 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.

1.11.3 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.

1.11.3.1 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.

1.11.3.2 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.

1.11.3.3 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.

1.11.3.4 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.

Personnel

1.12.1 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.

1.12.2 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.

1.12.3 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.

1.12.4 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

1.12.5 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:

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

1.12.5.2 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:

https://www.ecfr.gov/current/title-41/subtitle-C/chapter-102/subchapter-

C/part-102-74

1.12.5.3 Contractor personnel’s conduct shall not reflect discredit upon USDA-

ARS.

1.12.5.4 The Contractor shall ensure that personnel present a professional appearance.

1.12.5.5 The Contractor’s employees shall 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.

1.12.5.6 The Contractor shall remove from the job site any employee or subcontractor for reasons of misconduct or security.

1.12.5.6.1 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.

1.12.5.6.2 Disorderly Conduct - e.g., the use of abusive or offensive https://www.ecfr.gov/current/title-41/subtitle-C/chapter-102/subchapter-C/part-102-74 https://www.ecfr.gov/current/title-41/subtitle-C/chapter-102/subchapter-C/part-102-74 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.

1.12.5.6.3 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.

1.12.5.6.4 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.

1.12.5.6.5 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.

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

1.12.5.8 The Contractor shall 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.

1.12.5.9 The Contractor shall ensure no contractor employees conduct political related activities or events on the Installation.

PART 2

CONTRACTOR FURNISHED ITEMS AND SERVICES

2.1 Contractor Furnished Items and Responsibilities

The contractor shall furnish all personnel, equipment, materials, supplies, services, and shipping costs required to achieve the quality performance standards of the work in this contract, unless otherwise specified herein.

PART 3

GOVERNMENT FURNISHED ITEMS

3.1 Government Furnished Items

3.1.1 The government shall provide access to the Pall AquaWit IV unit.

3.1.2 The government will provide documentation to confirm that the Pall AquaWit IV unit has not been exposed to biological hazards or it has been properly decontaminated and it does not pose human exposure risk.

PART 4

SPECIFIC TASKS

4.1 General Project Requirements

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

4.1.2 The Contractor shall furnish a detailed technical proposal and detailed cost proposal.

4.1.3 The project is located at the National Bio and Agro-Defense Facility (NBAF) in

Manhattan, KS.

4.1.4 The Contractor will work with USDA personnel to ensure the project is accomplished in a timely manner.

4.1.5 Payment bid or other bonds may be required per the Contracting Officer’s bid package. Obtaining and the cost of these bonds is the responsibility of the

Contractor. Proof of Insurance may also be required.

4.2 Bid Schedule

4.2.1 All bids shall be broken out by individual tasks for review and approval. All bids must be in whole dollars, no cents. Otherwise, bids will be rounded to the nearest dollar.

4.3 Plan

4.3.1 The contractor shall 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.

4.4 Plan Implementation

4.4.1 The contractor shall perform work in accordance with NBAF’s safety standards and to the manufacturers’ specifications for the AquaWit IV unit which is manufactured by Pall Biotech and is covered under this PWS. USDA may request this unit be calibrated sooner or later than the contractors schedule depending on need and use of listed equipment.

4.4.2 CLIN 0001-0005

4.4.2.1 The contractor shall provide the annual calibration and recertification for the AquaWit IV unit.

4.4.2.2 The contractor shall work with the government to develop a calibration and maintenance program to ensure readiness of the equipment to prevent delay of the annual certification of the filter cartridges.

4.4.2.3 The contractor shall have adequate staffing to complete the scope of work and emergency service in a timely manner.

4.4.2.4 The contractor shall have Pall Biotech factory certified training with experience working with Pall AquaWit IV units. The CO or COR may request a copy of the appropriate documentation of the Pall Biotech approved training required to do the work listed in this PWS.

4.4.2.5 The contractor shall provide four (4) hours of training for the base year and each option years at no additional cost to the government.

4.4.2.6 The contractor shall provide all travel costs for the annual calibration and emergency service calls for the base year and each option years at no additional cost to the government.

4.4.2.7 The contractor shall provide all software updates during the POP at no additional cost to the government.

4.4.2.8 The contractor shall verify that the certifications were adequately performed and documented.

4.4.2.9 The contractor shall provide a formal report to include results, discussion, and all calibration information. The information shall be provided as both a hardcopy and digital copy in a format to be determined by the government.

4.4.2.10 As part of the calibration, the contractor shall provide a yearly preventative maintenance check and if needed, replace any lost, worn, or time sensitive parts.

PART 5

DELIVERABLES SCHEDULE

5.1 CLIN 0001 - 0005

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

5.1.2 The contractor shall provide an update of the work completed to the COR during the calibration process by the close of business on the first workday of the following week.

5.1.3 All required tasks for this Performance Work Statement shall be completed no later than dates listed in the POP for the appropriate contract period.

5.1.4 The contractor shall provide four (4) hours of training for the base year and each option years at no additional cost to the government.

5.1.5 The contractor shall provide all travel costs for the annual calibration and emergency service calls for the base year and each option years at no additional cost to the government.

5.1.6 The contractor shall provide all software updates during the POP at no additional cost to the government.

5.1.7 The contractor shall provide all need parts and labor to install and test the needed parts to maintain a working certifiable unit for the POP of this contract at no additional cost to the government.