Attachment 1 - PWS Vaporized Hydrogen Peroxide biodecontamination Cycle Development (003).pdf

Formatted: Right: 0.25"

United States Department of Agriculture Agricultural Research Service

PERFORMANCE WORK STATEMENT (PWS)

PROJECT: VAPORIZED HYDROGEN PEROXIDE

BIODECONTAMINATION CYCLE DEVELOPMENT FOR

TWO(2) ADDITIONAL AREAS

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

VHP Biodecontamination Cycle

Development

PART 1

GENERAL INFORMATION

Performance Work Statement for Biodecontamination Cycle Development. The needed work for this PWS is 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.

This PWS is for the STERIS VHP cycle development and process verification work for the two additional zones identified in the document Technical Exhibit One (TE-1). Each space or combined space requires engineering runs to develop the cycles and then subsequence Biological Indicator (BI) runs for verification of performance.

Cycle development work may include proof of concept (POC) runs involving the following:

Use with/without fans for distribution, Engineering runs to establish air flows and temperature, developing configurations for HEPA filter decontamination.

Definitions

ARS: Agricultural Research Services

CLIN: Contract Line-Item Numbers

COR: Contracting Officer’s Representative

CUI: Controlled Unclassified Information

NBAF: National Bio and Agro-Defense Facility

POP: Period of Performance

QCP: Quality Control Program

USDA: United States Department of Agriculture

Period of Performance

The period of performance (POP) will be for 12 calendar months.

Qualifications

The contractor must provide written documentation showing the specialists performing work under this PWS are individuals that have current certified Steris training, and are currently in good standing with Steris. They must also have documented experience with Steris vaporized hydrogen peroxide (VHP) biodecontamination cycle development in the same size and type of facility as NBAF. The government is requiring specialists that are trained to use the type and model of government owned Steris VHP equipment this includes experience and with/but not limited to documentation and compliance reports.

All applicable documentation must be provided in the submittal package for review and acceptance.

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, 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 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 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.

General Work Performance Location & Hours

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 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 must develop, implement, and maintain an effective QCP to ensure services are performed in accordance with industry standards and this PWS. The QCP, including changes, must be forwarded to, and accepted by the Contracting Officer (CO).

The Contractor must develop and implement procedures to identify, remedy, and prevent future deficiencies and submit to the Contracting Officer’s Representative (COR) for approval.

The contractor must 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 must 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 must 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 must describe methods of direct and indirect communication with USDA-ARS regarding performance of the contract.

1.10.3 The Contractor must 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 must 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 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.

1.11.1 On site records of all inspections conducted by the Contractor and necessary corrective action taken. This documentation must 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 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 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 must provide a contract manager who must be responsible for the performance of the work and must be the central point of contact with the Government. The name of this person and an alternate who must act for the contractor when the manager is absent must be designated in writing to the

CO. The contract manager or alternate must have full authority to act for the

Contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate must 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 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.

1.12.4 Employee Badges: 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.

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

1.12.5.2 Contractor personnel’s conduct must not reflect discredit upon USDA-

ARS.

1.12.5.3 The Contractor must ensure that personnel present a professional appearance.

1.12.5.4 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.

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

1.12.5.5.1 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.

1.12.5.5.2 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.

1.12.5.5.3 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.

1.12.5.5.4 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.

1.12.5.5.5 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.

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

1.12.5.7 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.

1.12.5.8 The Contractor must 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 must 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 will provide the needed Steris VHP equipment.

3.1.2 The government will provide documentation to confirm that the areas listed in TE-1 have not been exposed to biological hazards or have been properly decontaminated and do not pose human exposure risk.

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

3.1.4 The government will provide a technician to assist but this will NOT be deemed a formal process training.

3.1.5 The government will supply the consumables required (Vaprox, BIs, and CIs).

3.1.6 The government will supply an incubator capable of 57C .

3.1.7 The government will supply the needed fans, extension cords, and blowers.

3.1.8 The government will supply technical and organizational assistance.

3.1.9 The government will adjust an program the HVAC system during the cycle development, instruct which rooms are available at what times for decontamination.

3.1.10 The government will grant access to restricted areas when applicable.

3.1.11 The government will grant the ability to store instruments and materials on site.

3.1.12 Piping and dampers are installed by government.

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 must furnish a detailed technical proposal and detailed cost proposal.

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

4.2 Bid Schedule

4.2.1 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 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.

4.4 Plan Implementation

4.4.1 The contractor must perform work in accordance with NBAF’s safety standards and to the manufacturers’ specifications for the Steris equipment and VHP consumables.

The government may request a certain area be validated sooner or later than the contractors schedule depending on need and use of that area.

4.4.1.1 The contractor must provide a plan for the VHP application cycle development for the areas that are listed in the Technical Exhibit -1 (TE-1) for review and acceptance by the Techinical POC before the start of work.

4.4.1.2 First pass cycle parameters:

4.4.1.2.1 Air Flow Balance and Distribution (if applicable)

4.4.1.2.2 VHP Engineering Cycle

4.4.1.2.3 Cycle verification with biological indicator incubation & interpretation (1 cycle)

4.4.1.2.4 Cycle Development Report

4.4.1.3 First pass cycle parameters guidelines:

4.4.1.3.1 Establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.1.3.2 Airflow balance and distribution (if applicable): Balancing

Airflows: includes the adjustment of valve and damper positions in the VHP pipe work, to ensure that airflows at each VHP outlet is adequate for VHP treatment. This is to ensure good distribution and mixing with the space. Piping and dampers are installed by the government. A port shall be provided in each distribution pipe to accommodate air flow measurement device.

4.4.1.4 VHP Engineering Cycle:

4.4.1.4.1 A study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This cycle is performed with

VHP concentration sensor monitoring and Chemical indicators

(CI). This step can be combined with Cycle Verification step depending on the application.

4.4.1.4.2 Cycle verification with chemical and biological indicators- 1 cycle:

4.4.1.4.3 Cycle verification will include running the developed cycle using chemical and biological indicators to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and

VHP concentration will also be monitored during the cycle. The biological indicator results are interpreted at the end of the incubation period, as per the growth media directions for use.

4.4.1.5 Cycle development report:

4.4.1.5.1 The STERIS Cycle Development Report provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Provided in PDF format.

4.4.1.6 Prior to cycle development the Techinal POC and STERIS will agree on biological indicator placement, recovery, and interpretation method and will agree on the space or enclosure conditions (i.e. empty space, loaded space, environmental conditions, etc.). All applicable systems must be operational prior to this service (i.e. HVAC, control integration, building safety systems, etc.). Access to an incubator settable to 55-57 deg C will be provided if biological indicators are used.

4.4.1.7 VHP CD - Cycle Verification 3 Cycles - VHP Application

4.4.1.7.1 Cycle verification utilizing 3 consecutive cycles is typical for initial Performance Qualification or Re-Qualification. Cycle verification will include running the developed cycle using chemical and biological indicators to demonstrate efficacy.

4.4.1.7.2 Three consecutive cycles will be verified for the space or enclosure and VHP concentration will also be monitored during the cycle. The biological indicator results are interpreted at the end of the incubation period, as per the growth media directions for use.

4.4.1.7.3 Prior to the work the Techinal POC and STERIS will agree on biological indicator placement, recovery, and interpretation method and will agree on the space or enclosure conditions (i.e.

empty space, loaded space, environmental conditions, etc.).

4.1.1.1 All applicable systems will confirmed be operational prior to this service

(i.e. HVAC, control integration,building safety systems, etc.).

4.1.1.2 The contractor must verify that the operational requirements are met.

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

PART 5

DELIVERABLES SCHEDULE

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

5.1.2 The contractor must provide a monthly update of the work completed to the COR during the process by the close of business on the first workday of the following month.

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

5.1.4 This proposl must include all labor, travel costs, associated meetings and consultations, and temporary sensors and instrumentation for cycle development work.

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