SOW for SterisAreaValidation30JUN22(8)Final.docx

United States Department of Agriculture Agricultural Research Service

STATEMENT OF WORK

PROJECT: Vaporized Hydrogen Peroxide Biodecontamination Cycle Development, Air Flow Balancing and Distribution, Engineering Cycle, and Cycle Verification for Area and HEPA Housing Validation

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

Statement of Work

Vaporized Hydrogen Peroxide Biodecontamination Cycle Development, Air Flow Balancing and Distribution, Engineering Cycle, and Cycle Verification for Area and HEPA Housing Validation

PART 1

GENERAL INFORMATION

Statement of Work for at the National Bio and Agro-Defense Facility (NBAF).

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 NBAF facility has identified the need for vaporized hydrogen peroxide decontamination cycle development, air flow balancing and distribution, engineering cycle, and cycle verification for area and HEPA housing validation.

Definitions

ARS: Agricultural Research Services BSL-4: Biosafety Level 4 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 CFM: Cubic Feet per Minute QCP: Quality Control Program USDA: United States Department of Agriculture

Period of Performance

1.3.1 The Period of Performance shall be for a period of 180 days

Qualifications

The contractor shall provide written documentation showing the specialist performing work under this contract is a Steris trained, Steris recognized Vaporized Hydrogen Peroxide (VHP) specialist in good standing that has completed current training. This documentation shall be submitted to the contracting officer’s representative (COR) for approval prior to the individual coming on-site. The contractor must provide proof of training that qualifies the specialists to perform the validation procedures.

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 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

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 SOW. 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 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 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 SOW 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 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 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 the needed Steris Vaporized Hydrogen Peroxide Biodecontamination (VHP) units

3.1.2 The government will provide documentation to confirm that areas and HEPA housings have not been exposed to biological hazards and do not pose human exposure risk.

3.1.3 The government shall supply the water and electricity to operate the Steris Vaporized Hydrogen Peroxide Biodecontamination (VHP) units.

3.1.4 The government shall provide the Steris recommended biological indicators, Steris recommended humidity indicators, along with the Steris recommended chemical indicators identify by the contractor to meet the requirements of this SOW.

3.1.5 The government shall provide the needed STERIS Vaprox.

PART 4

SPECIFIC TASKS

4.1 General Project Requirements

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

4.1.2 The Contractor shall furnish a detailed technical proposal and detailed cost proposal, including all prime and sub pricing showing labor cost, material cost, OH and Profit and estimated service time including crew size per independent Task listed herein.

4.1.3 The contractor will provide a turnkey product to include, but not limited to, all studies, reports, data, materials as specified and the correct and proper installation of all material. Contractor will provide all permits as required.

4.1.4 The project is located at the National Bio and Agro-Defense Facility (NBAF) in Manhattan, KS.

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

4.1.6 The Contractor’s work shall adhere to the criteria stated within these project requirements and specifications.

4.1.7 Materials and Installation shall meet the applicable sections of the Uniform Federal Guide Specifications (UFGS), including UFGS 14 24 23. The UFGS specifications can be found on the listed on the Whole Building Design Guide Construction Criteria Base UFGS page at: https://www.wbdg.org/ccb/browse_cat.php?c=3.

4.1.8 The Contractor’s work shall adhere to the criteria stated within these project requirements, and specifications. All construction shall comply with applicable federal, state, and local code requirements as well as current industry standards, (i.e.: UBC, NFPA, UL, ACI, ANSI, FCC, ASTM, NEC, NEMA, etc.) and health and safety codes, in effect at the time of Task order award.

4.1.9 All codes and standards referenced in this specification will be to the edition of the references as detailed in this section. All materials and Work and Services to be performed under these specifications shall follow the Codes listed in this section or as determined by the authority having jurisdiction.

4.1.10 Davis Bacon Wage Rates apply to all construction task orders more than $2,000. Employee payroll logs for the project will be required to verify wage rates are being adhered to.

4.1.11 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 will also be required.

4.1.12 Shutoff of utilities, if required, shall be scheduled no less than five (5) working days in advance.

4.1.13 The Contractor is responsible for visiting the site prior to submitting a bid to observe existing conditions. No compensation will be provided for conditions that would be visible during an on-site visit for persons experienced performing this type of work.

4.1.14 Clean up and removal of all debris from construction site once job is completed.

4.1.15 Building will be occupied while construction is ongoing. Contractor will schedule work with location to allow location to meet current needs.

4.2 Bid Schedule

4.2.1 All bids shall be broken out by individual tasks for potential execution dependent on cost, time, and estimated impacts. 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 SOW 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 to accomplish the VHP validation effort. USDA may request certain areas be validated sooner or later than the contractors schedule depending on need and use of listed equipment. All measurements/volumes are approximate.

4.4.2 CLIN 1

The contractor shall provide VHP cycle development – VHP Application for area A dimensions and cfm airflow outline in TE-1. Area is 2,285 cu. ft. in size.

4.4.2.1 Prior to cycle development the government and the contractor shall agree on the biological indicator (B.I.) hanging and interpretation method and shall agree on the space or enclosure conditions (i.e., empty space, loaded space, environmental conditions, etc.).

4.4.2.1.1 For the development of one (1) cycle this task shall include at the minimum the items listed below. This task shall be coordinated and reviewed in conjunction with the Technical POC.

4.4.2.1.1.1 The contractor shall provide first pass cycle parameters. This task shall establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.2.1.1.2 The contractor shall provide air flow balance and distribution (if applicable). This task shall balance airflows which shall include 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 provided port shall be use in each distribution pipe to accommodate air flow measurement device.

4.4.2.1.1.3 The contractor shall provide VHP engineering cycle that must include a study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This shall be performed with VHP concentration sensor monitoring and Chemical Indicators (CI). This step may be combined with Cycle Verification step depending on the application.

4.4.2.1.1.4 The contractor shall provide Cycle Verification with B.I. incubation and interpretation for one (1) cycle. Cycle verification shall include running the developed cycle using chemical indicators (C.I.’s) and biological indicators (B.I.’s) to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and VHP concentration will also be monitored during the cycle. Contractor shall recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results shall be interpreted by the contractor at the end of the incubation period, as per the growth media directions for use.

4.4.2.1.1.5 The contractor shall provide a cycle development report labeled “Cycle Development Report” that provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Information shall be provided in both hard and digital format. Government will provide means for digital transfer.

4.4.2.1.1.6 Cycle Verification three (3) Cycles – VHP Application

4.4.2.1.1.6.1 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 (C.I.'s) and biological indicators (B.I.'s) to demonstrate efficacy. Three consecutive cycles will be verified for the space or enclosure and VHP concentration will also be monitored during the cycle. STERIS will recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results are interpreted at the end of the incubation period, as per the growth media directions for use. Note: Government and STERIS will agree on BI hanging and interpretation method during the Design

4.4.3 CLIN 2

The contractor shall provide VHP cycle development – VHP Application for area B dimensions and cfm airflow outline in TE-1. Area is 7,035 cu. ft. in size.

4.4.3.1 Prior to cycle development the government and the contractor shall agree on the biological indicator (B.I.) hanging and interpretation method and shall agree on the space or enclosure conditions (i.e., empty space, loaded space, environmental conditions, etc.).

4.4.3.1.1 For the development of one (1) cycle this task shall include at the minimum the items listed below. This task shall be coordinated and reviewed in conjunction with the Technical POC.

4.4.3.1.1.1 The contractor shall provide first pass cycle parameters. This task shall establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.3.1.1.2 The contractor shall provide air flow balance and distribution (if applicable). This task shall balance airflows which shall include 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 provided port shall be use in each distribution pipe to accommodate air flow measurement device.

4.4.3.1.1.3 The contractor shall provide VHP engineering cycle that must include a study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This shall be performed with VHP concentration sensor monitoring and Chemical Indicators (CI). This step may be combined with Cycle Verification step depending on the application.

4.4.3.1.1.4 The contractor shall provide Cycle Verification with B.I. incubation and interpretation for one (1) cycle. Cycle verification shall include running the developed cycle using chemical indicators (C.I.’s) and biological indicators (B.I.’s) to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and VHP concentration will also be monitored during the cycle. Contractor shall recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results shall be interpreted by the contractor at the end of the incubation period, as per the growth media directions for use.

4.4.3.1.1.5 The contractor shall provide a cycle development report labeled “Cycle Development Report” that provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Information shall be provided in both hard and digital format. Government will provide means for digital transfer.

4.4.3.1.1.6 Cycle Verification three (3) Cycles – VHP Application

4.4.2.1.1.6.1 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 (C.I.'s) and biological indicators (B.I.'s) to demonstrate efficacy. Three consecutive cycles will be verified for the space or enclosure and VHP concentration will also be monitored during the cycle. STERIS will recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results are interpreted at the end of the incubation period, as per the growth media directions for use. Note: Government and STERIS will agree on BI hanging and interpretation method during the Design

4.4.4 CLIN 3

The contractor shall provide VHP cycle development – VHP Application for area C dimensions and cfm airflow outline in TE-1. Area is 3,155 cu. ft. in size.

4.4.4.1 Prior to cycle development the government and the contractor shall agree on the biological indicator (B.I.) hanging and interpretation method and shall agree on the space or enclosure conditions (i.e., empty space, loaded space, environmental conditions, etc.).

4.4.4.1.1 For the development of one (1) cycle this task shall include at the minimum the items listed below. This task shall be coordinated and reviewed in conjunction with the Technical POC.

4.4.4.1.1.1 The contractor shall provide first pass cycle parameters. This task shall establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.4.1.1.2 The contractor shall provide air flow balance and distribution (if applicable). This task shall balance airflows which shall include 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 provided port shall be use in each distribution pipe to accommodate air flow measurement device.

4.4.4.1.1.3 The contractor shall provide VHP engineering cycle that must include a study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This shall be performed with VHP concentration sensor monitoring and Chemical Indicators (CI). This step may be combined with Cycle Verification step depending on the application.

4.4.4.1.1.4 The contractor shall provide Cycle Verification with B.I. incubation and interpretation for one (1) cycle. Cycle verification shall include running the developed cycle using chemical indicators (C.I.’s) and biological indicators (B.I.’s) to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and VHP concentration will also be monitored during the cycle. Contractor shall recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results shall be interpreted by the contractor at the end of the incubation period, as per the growth media directions for use.

4.4.4.1.1.5 The contractor shall provide a cycle development report labeled “Cycle Development Report” that provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Information shall be provided in both hard and digital format. Government will provide means for digital transfer.

4.4.4.1.1.6 Cycle Verification three (3) Cycles – VHP Application

4.4.2.1.1.6.1 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 (C.I.'s) and biological indicators (B.I.'s) to demonstrate efficacy. Three consecutive cycles will be verified for the space or enclosure and VHP concentration will also be monitored during the cycle. STERIS will recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results are interpreted at the end of the incubation period, as per the growth media directions for use. Note: Government and STERIS will agree on BI hanging and interpretation method during the Design

4.4.5 CLIN 4

The contractor shall provide VHP cycle development – VHP Application for area D dimensions and cfm airflow outline in TE-1. Area is 18,554 cu. ft. in size.

4.4.5.1 Prior to cycle development the government and the contractor shall agree on the biological indicator (B.I.) hanging and interpretation method and shall agree on the space or enclosure conditions (i.e., empty space, loaded space, environmental conditions, etc.).

4.4.5.1.1 For the development of one (1) cycle this task shall include at the minimum the items listed below. This task shall be coordinated and reviewed in conjunction with the Technical POC.

4.4.5.1.1.1 The contractor shall provide first pass cycle parameters. This task shall establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.5.1.1.2 The contractor shall provide air flow balance and distribution (if applicable). This task shall balance airflows which shall include 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 provided port shall be use in each distribution pipe to accommodate air flow measurement device.

4.4.5.1.1.3 The contractor shall provide VHP engineering cycle that must include a study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This shall be performed with VHP concentration sensor monitoring and Chemical Indicators (CI). This step may be combined with Cycle Verification step depending on the application.

4.4.5.1.1.4 The contractor shall provide Cycle Verification with B.I. incubation and interpretation for one (1) cycle. Cycle verification shall include running the developed cycle using chemical indicators (C.I.’s) and biological indicators (B.I.’s) to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and VHP concentration will also be monitored during the cycle. Contractor shall recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results shall be interpreted by the contractor at the end of the incubation period, as per the growth media directions for use.

4.4.5.1.1.5 The contractor shall provide a cycle development report labeled “Cycle Development Report” that provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Information shall be provided in both hard and digital format. Government will provide means for digital transfer.

4.4.5.1.1.6 Cycle Verification three (3) Cycles – VHP Application

4.4.2.1.1.6.1 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 (C.I.'s) and biological indicators (B.I.'s) to demonstrate efficacy. Three consecutive cycles will be verified for the space or enclosure and VHP concentration will also be monitored during the cycle. STERIS will recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results are interpreted at the end of the incubation period, as per the growth media directions for use. Note: Government and STERIS will agree on BI hanging and interpretation method during the Design

4.4.6 CLIN 5

The contractor shall provide VHP cycle development – VHP Application for area E dimensions and cfm airflow outline in TE-1. Area is 14,700 cu. ft. in size.

4.4.6.1 Prior to cycle development the government and the contractor shall agree on the biological indicator (B.I.) hanging and interpretation method and shall agree on the space or enclosure conditions (i.e., empty space, loaded space, environmental conditions, etc.).

4.4.6.1.1 For the development of one (1) cycle this task shall include at the minimum the items listed below. This task shall be coordinated and reviewed in conjunction with the Technical POC.

4.4.6.1.1.1 The contractor shall provide first pass cycle parameters. This task shall establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.6.1.1.2 The contractor shall provide air flow balance and distribution (if applicable). This task shall balance airflows which shall include 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 provided port shall be use in each distribution pipe to accommodate air flow measurement device.

4.4.6.1.1.3 The contractor shall provide VHP engineering cycle that must include a study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This shall be performed with VHP concentration sensor monitoring and Chemical Indicators (CI). This step may be combined with Cycle Verification step depending on the application.

4.4.6.1.1.4 The contractor shall provide Cycle Verification with B.I. incubation and interpretation for one (1) cycle. Cycle verification shall include running the developed cycle using chemical indicators (C.I.’s) and biological indicators (B.I.’s) to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and VHP concentration will also be monitored during the cycle. Contractor shall recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results shall be interpreted by the contractor at the end of the incubation period, as per the growth media directions for use.

4.4.6.1.1.5 The contractor shall provide a cycle development report labeled “Cycle Development Report” that provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Information shall be provided in both hard and digital format. Government will provide means for digital transfer.

4.4.6.1.1.6 Cycle Verification three (3) Cycles – VHP Application

4.4.2.1.1.6.1 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 (C.I.'s) and biological indicators (B.I.'s) to demonstrate efficacy. Three consecutive cycles will be verified for the space or enclosure and VHP concentration will also be monitored during the cycle. STERIS will recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results are interpreted at the end of the incubation period, as per the growth media directions for use. Note: Government and STERIS will agree on BI hanging and interpretation method during the Design

4.4.7 CLIN 6

The contractor shall provide VHP cycle development – VHP Application for area F dimensions and cfm airflow outline in TE-1. Area is 5,710 cu. ft. in size.

4.4.7.1 Prior to cycle development the government and the contractor shall agree on the biological indicator (B.I.) hanging and interpretation method and shall agree on the space or enclosure conditions (i.e., empty space, loaded space, environmental conditions, etc.).

4.4.7.1.1 For the development of one (1) cycle this task shall include at the minimum the items listed below. This task shall be coordinated and reviewed in conjunction with the Technical POC.

4.4.7.1.1.1 The contractor shall provide first pass cycle parameters. This task shall establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.7.1.1.2 The contractor shall provide air flow balance and distribution (if applicable). This task shall balance airflows which shall include 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 provided port shall be use in each distribution pipe to accommodate air flow measurement device.

4.4.7.1.1.3 The contractor shall provide VHP engineering cycle that must include a study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This shall be performed with VHP concentration sensor monitoring and Chemical Indicators (CI). This step may be combined with Cycle Verification step depending on the application.

4.4.7.1.1.4 The contractor shall provide Cycle Verification with B.I. incubation and interpretation for one (1) cycle. Cycle verification shall include running the developed cycle using chemical indicators (C.I.’s) and biological indicators (B.I.’s) to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and VHP concentration will also be monitored during the cycle. Contractor shall recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results shall be interpreted by the contractor at the end of the incubation period, as per the growth media directions for use.

4.4.7.1.1.5 The contractor shall provide a cycle development report labeled “Cycle Development Report” that provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Information shall be provided in both hard and digital format. Government will provide means for digital transfer.

4.4.7.1.1.6 Cycle Verification three (3) Cycles – VHP Application

4.4.2.1.1.6.1 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 (C.I.'s) and biological indicators (B.I.'s) to demonstrate efficacy. Three consecutive cycles will be verified for the space or enclosure and VHP concentration will also be monitored during the cycle. STERIS will recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results are interpreted at the end of the incubation period, as per the growth media directions for use. Note: Government and STERIS will agree on BI hanging and interpretation method during the Design

4.4.8 CLIN 7

The contractor shall provide VHP cycle development – VHP Application for area G dimensions and cfm airflow outline in TE-1. Area is 6,550 cu. ft. in size.

4.4.8.1 Prior to cycle development the government and the contractor shall agree on the biological indicator (B.I.) hanging and interpretation method and shall agree on the space or enclosure conditions (i.e., empty space, loaded space, environmental conditions, etc.).

4.4.8.1.1 For the development of one (1) cycle this task shall include at the minimum the items listed below. This task shall be coordinated and reviewed in conjunction with the Technical POC.

4.4.8.1.1.1 The contractor shall provide first pass cycle parameters. This task shall establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.8.1.1.2 The contractor shall provide air flow balance and distribution (if applicable). This task shall balance airflows which shall include 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 provided port shall be use in each distribution pipe to accommodate air flow measurement device.

4.4.8.1.1.3 The contractor shall provide VHP engineering cycle that must include a study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This shall be performed with VHP concentration sensor monitoring and Chemical Indicators (CI). This step may be combined with Cycle Verification step depending on the application.

4.4.8.1.1.4 The contractor shall provide Cycle Verification with B.I. incubation and interpretation for one (1) cycle. Cycle verification shall include running the developed cycle using chemical indicators (C.I.’s) and biological indicators (B.I.’s) to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and VHP concentration will also be monitored during the cycle. Contractor shall recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results shall be interpreted by the contractor at the end of the incubation period, as per the growth media directions for use.

4.4.8.1.1.5 The contractor shall provide a cycle development report labeled “Cycle Development Report” that provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Information shall be provided in both hard and digital format. Government will provide means for digital transfer.

4.4.8.1.1.6 Cycle Verification three (3) Cycles – VHP Application

4.4.2.1.1.6.1 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 (C.I.'s) and biological indicators (B.I.'s) to demonstrate efficacy. Three consecutive cycles will be verified for the space or enclosure and VHP concentration will also be monitored during the cycle. STERIS will recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results are interpreted at the end of the incubation period, as per the growth media directions for use. Note: Government and STERIS will agree on BI hanging and interpretation method during the Design

4.4.9 CLIN 8

The contractor shall provide VHP cycle development – VHP Application for area H dimensions and cfm airflow outline in TE-1. Area is 10,400 cu. ft. in size.

4.4.9.1 Prior to cycle development the government and the contractor shall agree on the biological indicator (B.I.) hanging and interpretation method and shall agree on the space or enclosure conditions (i.e., empty space, loaded space, environmental conditions, etc.).

4.4.9.1.1 For the development of one (1) cycle this task shall include at the minimum the items listed below. This task shall be coordinated and reviewed in conjunction with the Technical POC.

4.4.9.1.1.1 The contractor shall provide first pass cycle parameters. This task shall establish initial cycle parameters based on similar applications, applicable standards and or STERIS VHP cycle development guide.

4.4.9.1.1.2 The contractor shall provide air flow balance and distribution (if applicable). This task shall balance airflows which shall include 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 provided port shall be use in each distribution pipe to accommodate air flow measurement device.

4.4.9.1.1.3 The contractor shall provide VHP engineering cycle that must include a study of VHP distribution within the space, chamber or enclosure being subjected to VHP. This shall be performed with VHP concentration sensor monitoring and Chemical Indicators (CI). This step may be combined with Cycle Verification step depending on the application.

4.4.9.1.1.4 The contractor shall provide Cycle Verification with B.I. incubation and interpretation for one (1) cycle. Cycle verification shall include running the developed cycle using chemical indicators (C.I.’s) and biological indicators (B.I.’s) to demonstrate efficacy. One cycle will be verified for the space, chamber, or enclosure and VHP concentration will also be monitored during the cycle. Contractor shall recover all biological indicators, aseptically transfer them to growth media and incubate for the required period of time. The results shall be interpreted by the contractor at the end of the incubation period, as per the growth media directions for use.

4.4.9.1.1.5 The contractor shall provide a cycle development report labeled “Cycle Development Report” that provides comprehensive documentation of the procedure followed, the final cycle parameters and the results achieved. Information shall be provided in both hard and digital format. Government will provide means for digital transfer.

4.4.9.1.1.6 Cycle Verification three (3) Cycles – VHP Application

4.4.2.1.1.6.1 Cycle verification utilizing 3 consecutive cycles is typical for initial Performance Qualification or Re-Qualification.