Attachment 1 PWS ClorDiSys Decontaination Training-CD.pdf

United States Department of Agriculture Agricultural Research Service

Performance Work Statement

PROJECT:

Vent Filter Decontamination and Validation Training using ClorDiSys MINIDOX-M

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

PART 1

GENERAL INFORMATION:

Performance Work Statement for the vent filter decontamination and validation training using the National Bio and Agro-Defense Facility (NBAF) owned ClorDiSys MINIDOX-M units.

1.0 Definitions: USDA - United States Department of Agriculture

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

1.1 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 National Bio and Agro-Defense Facility (NBAF) has the need for instruction and hands-on training of the government owned ClorDiSys Minidox-M decontamination equipment. This training will be developed for the NBAF BioSafety team who are operators and stewards of the equipment along with other NBAF departments who are stakeholders in the chlorine dioxide decontamination process.

This training will use NBAF owned ClorDiSys Minidox-M units to decontaminate plumbing vent filter housings, as well as the Camfil CamControl Carts used to scan and certify HEPA filters installed in the HVAC system using chlorine dioxide gas. Training topics to be included are basic start-up, general operation, general troubleshooting, daily preventative maintenance and routine troubleshooting common errors and problems associated with the equipment, entering, and adjusting the cycle parameters and the instruction needed to perform the operational decontamination of the listed items.

1.2 Period of Performance: The period of performance (POP) shall be for a period of 180 days after award.

1.3 Qualifications: The specialist performing work under this contract shall provide documentation verifying the individual is a ClorDiSys trained, ClorDiSys recognized chlorine dioxide gas decontamination specialist in good standing that has completed current factory approved training on the ClorDiSys Minidox-M and have authorized access to ClorDiSys proprietary software to make modifications to the software, or to provide the needed modifications to the hardware to meet the requirements of this PWS.

The specialist shall also be proficient in the operational decontamination of equipment, Pall and PRI filter housings, HEPA filter caissons and decontamination vestibules in a high containment facility. This documentation shall be submitted to the contracting officer’s representative (COR) for approval prior to the individual coming on-site.

1.4 Security Requirements: Personnel employed by the Contractor or any representative of, or agent of the Contractor, entering this facility shall conform to the facility security regulations. The Contractor shall provide all information required for background checks to meet facility access requirements as performed by the facility security office. Contractor personnel shall comply with all personal identity verification requirements as directed by USDA-ARS Security office. Each person accessing the site will be required to provide personal details, (full name, DOB, SSN, DL#) and will undergo a routine background check, such as a National Agency Check with additional inquiries, which may include a criminal and credit check. Details required for the check should be submitted the security office NLT 5 days prior to the visit. Results of this check may return earlier; however, it should not be planned to have results earlier than 5 days. If, while on site the contractor/vendor will have access to sensitive information, they must complete A Non- Disclosure Agreement (NDA), along with the required training. This training will most likely be completed by reviewing a series of slides covering the topics of the definition of controlled unclassified information (CUI), access, handling, distribution, storage, and destruction of CUI. Each person will acknowledge receiving and understanding the training on the NDA. The process should not exceed two hours. Acknowledgement and completion of the NDA will be turned in with the form required for the background check. Results will be returned through the Contracting Officer or Contracting Officer Representative.

1.5 Physical Security: The certifying engineer/technician performing work under this contract shall safeguard all USDA-ARS equipment, information and property provided for Contractor use. At the close of each work period, USDA-ARS facilities, equipment, and materials shall be secured.

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

1.7 Federal Observed Holidays:

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

1.8 Contractor Performance Assessments: The Contractor will evaluate his contract services, correcting any deficiencies, which deviate from the commercially acceptable standard for the start-up, calibration, and preventative maintenance work under this contract. The Contractor shall furnish a copy of the evaluation/inspection reports to the designated COR for this contract as requested.

• The name of the Project Manager

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

• 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.

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

• 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.

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

1.10 Contracting Officer’s Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration the COR is authorized to perform the following functions: Assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance;

maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, and specifications; monitor Contractor's performance and notifies both the CO and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.11 Personnel:

• 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.

• 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.

• 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.

• 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.

• 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 not an all-inclusive list of specific conduct NOT be condoned:

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

NBAF.

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

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

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

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

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

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

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

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

Contractor personnel’s conduct shall not reflect discredit upon USDA-ARS. The Contractor shall ensure that personnel present a professional appearance. The Contractor’s employees shall observe and comply with all local policies and procedures concerning fire, safety, environmental protection, sanitation, security, and possession of firearms or other lethal or illegal weapons or substance. The Contractor is responsible for ensuring that any contractor employees providing services under this contract conduct themselves and perform services in a professional, safe, and responsible manner. The Contractor shall remove from the job site any employee for reasons of misconduct or security. Particular attention should be paid to acceptance of gifts/ gratuities, and on non-disclosure of https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.gsa.gov%2Fgraphics%2Fogp%2FFed_Rules_Regs8_5x11_Final2005_R27-s10_0Z5RDZ-i34K-pR.pdf&data=04%7C01%7C%7C54b00ee0923643936b2c08d8cd1369aa%7Ced5b36e701ee4ebc867ee03cfa0d4697%7C0%7C0%7C637484830543567584%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=989H33mimH1FYJRUceSd650svoHfO%2FOt6qQQJmCN6VQ%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.gsa.gov%2Fgraphics%2Fogp%2FFed_Rules_Regs8_5x11_Final2005_R27-s10_0Z5RDZ-i34K-pR.pdf&data=04%7C01%7C%7C54b00ee0923643936b2c08d8cd1369aa%7Ced5b36e701ee4ebc867ee03cfa0d4697%7C0%7C0%7C637484830543567584%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=989H33mimH1FYJRUceSd650svoHfO%2FOt6qQQJmCN6VQ%3D&reserved=0 sensitive or classified information. The Contractor shall ensure employee conduct complies with 41 USC 423 relative to release of acquisition related information, or actions or discussions which may prejudice future competitions. The Contractor shall ensure no contractor employees conduct political related activities or events on the Installation.

1.12 Bid Schedule: All bids must be in whole dollars, no cents, otherwise, bids will be rounded to the nearest dollar. The government will award all CLINs as one package/price.

PART 2

CONTRACTOR FURNISHED ITEMS AND SERVICES

2.0 CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

2.1 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 EQUIPMENT

3.0 GOVERNMENT FURNISHED EQUIPMENT:

3.1 ClorDiSys Minidox-M Portable Chlorine Dioxide Gas Generators

3.2 The needed supplies for the Minidox-M to complete the requirements for this

PWS.

3.3 The Chemical Indicators (CIs) and Biological Indicators (BIs) and the needed incubators.

3.4 Access to the needed areas to complete the work.

3.5 The government shall provide documentation to confirm that areas and specific elements that are listed in this PWS have not been exposed to biological hazards and do not pose human exposure risk.

PART 4

SPECIFIC TASKS

4.0 Provide a Plan: The contractor shall propose 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 to the start of work. The plan shall outline how the contractor will perform the necessary activities to develop the appropriate cycle parameters to decontaminate the listed elements of this PWS.

4.2.1 The contractor shall perform work in accordance with NBAF’s safety standards to accomplish the validation of the decontamination effort.

USDA may request certain elements be validated sooner or later than the contractors schedule depending on need and use of listed equipment. The contractor shall coordinate with the Technical POC/or designee on plan implementation of all the CLIN components. The cycle development results must be approved by the Technical POC/or designee prior to proceeding to the cycle validation stage CLIN. Daily reports with preliminary data for both the BI/CI must be provided to the Technical POC/or designee at the beginning of the day to identify any course correction with the cycle parameters or element configuration. This preliminary data must be provided and approved by the Technical POC/or designee before initiates for the day. If a cycle parameter or configuration is required to be altered the contractor will need to repeat the validations with the new requirements. Any stop work or corrective action plans must be approved by CO/COR.

4.2.2 At a minimum, an element run to be considered

successful, the run shall produce a 100% pass rate of biological indicators (BIs) and chemical integrators (CIs - CIs must fully max out at the acceptance range agreed upon by the Technical POC). and must maintain readings as specified in the plan implementation.

4.3 The contractor shall provide a formal report of the cycle development, and the cycle validation activities. The report will include results, discussion, and all calibration information.

The report shall include calculations and procedures used during the validation.

4.4 Results shall be provided in both hard and digital format. The final report will be provided in PDF format. The raw data and analytical charts will be provided in Excel format. Government will provide means for digital transfer.

4.4.1 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.

4.5 Services: The contractor shall perform work in accordance with NBAF’s safety standards and to the manufacturers’ specifications of the ClorDiSys Minidox-M units. USDA may request certain elements of the training be initiated sooner or later than the contractors schedule depending on the governments need.

4.5.1 The contractor shall inspect the work/training site, equipment and supplies and advise the government on requirements needed to prevent delay or unsatisfactory results, this will include the needed building utilities, fittings to connect the Minidox-M to the listed elements and all other requirements needed to operate the units within the manufacture specifications and in the most efficient matter. After inspection the contractor shall advise the government of the needed supplies for the government to procure in a timely matter so not to cause a delay of the elements of this

PWS.

4.5.2 Training: The contractor shall provide training

developed for the NBAF BioSafety team who are operators and stewards of the equipment along with other NBAF departments who are stakeholders in the chlorine dioxide decontamination process.

4.5.2.1 The contractor shall work to develop the

contents of the contractors’ provided training package to ensure the outcome meets the goals of the government. A final review and approval by the NBAF Biorisk training coordinator will be needed before training starts.

5.0 Elements for the Vent Filter Decontamination and Validation: The following elements are the minimum requirements to be performed for the vent filter decontamination and validation training using ClorDiSys Minidox-M units.

5.01 CLIN 1: Assessment of ability to Modify the existing unit Provide a written assessment of

5.1 CLIN 2: Modification of Minidox-Units: The modification

of four (4) units’ hardware or software to allow the units to work independently of the Camfil CamControl boxes.

5.1.1 The Minidox unit’s initial configuration is the

decontamination of the Camfil CamControl valve box and tubing after a hot scan.

5.2 CLIN 3: Cycle Development

5.2.1 Prior to cycle development the government and the

contractor shall agree on the number, location, and interpretation of the BIs, CIs. This element shall be coordinated and reviewed in conjunction with the Technical POC.

5.2.2 The contractor shall complete cycle development of

the decontamination of one (1) Camfil CamControl Cart and associated tubing, one (1) of each listed Pall and Progressive Recovery (PRI) vent filter housings in TE-1, one (1) Camfil Caisson, and one (1) In-situ equipment decontamination. These tasks shall be coordinated and reviewed in conjunction with the Technical POC.

5.2.3 This cycle development shall establish initial cycle

parameters based on similar applications, applicable standards and or ClorDiSys cycle development guide.

5.2.4 The contractor shall provide a report for the cycle

development which will identify the parameters that were used to achieve a 100% pass result.

5.2.5 The contractor shall provide training showing how to

use chlorine dioxide to develop and perform a decontamination process for each of the listed elements.

5.3 CLIN 4: Cycle Validation

5.3.1 Cycle Validation is Three (3) Successful runs.

5.3.2 Once the final parameters for the cycle have been determined, the contractor shall complete three (3) consecutive successful runs for each cycle and configuration described below.

5.3.3 Cycle verification will include running the developed cycle using CIs, BIs to demonstrate efficacy and shall be coordinated and reviewed in conjunction with the Technical POC.

5.3.4 The government shall recover all BIs and CIs and process and interpret results.

5.3.5 The contractor shall provide a Standard Operating Procedure (SOP) for the cycle validation.

5.3.6 The contractor shall provide a report of the cycle validation results to include biological indicator and chemical integrator results.

5.4 CLIN 5: Training:

5.4.1 Overview of the use and procedure of use for chlorine

dioxide and to develop and perform a decontamination process for each of the below listed elements.

5.4.1.1 Camfil CamControl Carts and Tubing

5.4.1.2 Pall and Progressive Recovery Filter Housings

5.4.1.3 Camfil Caissons

5.4.1.4 In-situ decontamination of equipment

PART 5

5.0 DELIVERABLES SCHEDULE:

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

5.2 The contractor shall verify that the operational requirements are met.

5.3 All required tasks shall be completed no later than 180 days after award.

5.4 All bids shall include travel and all associated costs.

5.5 Contractor shall provide shadowing opportunities to NBAF personnel directly associated with system functions for up to ten (10) personnel throughout the course of service. This shall not impede on the production or work of the contractor but will provide visualization of the process in its entirety. The frequency and the scheduling of the shadowing will be determined and coordinated with and in conjunction with the contractor.

5.6 The contractor shall provide a daily update of the preliminary data from the previous day to the Technical POC/designee and receive approval before work on the new day can be initiated.

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

5.8 The contractor shall provide the government with all the reports as specified in this PWS twenty (20) days before the end of the performance period to allow for ample feedback and adjustments.

5.9 The contractor shall work to develop the contents of the contractors’ provided training package to ensure the outcome meets the goals of the government.