Attachment B - STENS SOW 09-28-2022.docx

FOUO. This document contains pre-decisional deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b)(5). Do not release without prior approval of the Department of Homeland Security.

DHS S&T ONL Plum Island Closure and Support (PICS) Program Contract Scope of Work:

Scientific, Technical and Engineering Support for Plum Island Animal Disease Center (PIADC) Decontamination and Closure

Contents

1. Purpose The Department of Homeland Security Science and Technology Directorate (DHS S&T) Office of National Laboratories (ONL) is seeking proposals for Scientific, Technical and Engineering Support for PIADC Decontamination and Closure of the major facility buildings (Buildings 257, 102, 101, and 111) and exterior areas (as needed) at the Plum Island Animal Disease Center (PIADC). The Plum Island Closure and Support (PICS) program requires senior and technical level expertise to: collaborate in planning/executing applied scientific activities for decontamination method assessment and development, develop decontamination and validation plans, deliver engineering and logistics to implement methods, and provide third-party verification testing.

Measures to facilitate and ensure an approved end-state for the various PIADC structures utilized for execution of, and support for scientific activities will entail various mechanisms of sampling, disinfection, and decontamination. These activities will occur as part of a coordinated plan for facility closure and will entail simultaneous activities at multiple sites on the facility grounds. Consequently, the PICS program requires senior and technical level support to provide biological decontamination and decommissioning support services including, but not limited to: planning/executing scientific activities for decontamination methods and validation to include analyses involving various technologies, sampling approaches, monitoring methods, among others; translating results of method development and validation into plans for terminal facility decontamination; delivery of engineering planning, engineering design, and logistics to support implementation of facility decontamination methods and/or independent third-party review of such developed products; integration of scientific, engineering and other technical data in order to produce a comprehensive facility decontamination plan; operation of an on-island mobile laboratory for provision of independent third-party verification/validation testing of biological and chemical indicators (Self-Contained Biological Indicators [SCBIs], spore strips, integrators); and development of documentation of verification/validation results for review by regulatory bodies.

Each activity will be accomplished while working collaboratively with additional PICS federal and contracted personnel, both onsite and offsite. In addition, it should be noted that the subject activities of this RFP do not entail the performance of the primary operations and maintenance functions or physical execution of decontamination activities for the biocontainment buildings at Plum Island.

1.1 Background

Since 1954, the Plum Island Animal Disease Center (PIADC), located on Plum Island, New York, has been operated by the Federal Government for the purposes of agricultural research, training and diagnostics involving transboundary (foreign) animal diseases threatening U.S. agricultural production systems. In 2003, in accordance with the Homeland Security Act, ownership of PIADC was transferred from the U.S. Department of Agriculture (USDA) to the Department of Homeland Security (DHS), including the “assets and liabilities of the Center” (6USC190). The mission of PIADC is now being transferred to the National Bio and Agro-Defense Facility (NBAF), which is currently under construction in Manhattan, Kansas.

Pursuant to the Consolidated Security, Disaster Assistance, and Continuing Appropriation Act of 2009, Congress directed DHS to sell Plum Island (through the GSA) given the decision to transition the scientific mission to the NBAF (P.L. 110-329 - Section 540). Ultimately, as part of the Consolidated Appropriations Act, 2021, which was enacted in December 2021, the prior sale requirement was repealed and revised to ensure that the Plum Island property “be disposed of as a single consolidated asset” by GSA (P.L. 116-260 – Division FF Title V Section 501).

To prepare the island for cessation of government activities, the DHS PICS program will ensure closure of the Plum Island property in a manner that reduces risks to an acceptable regulatory level for release to any public entity. The PICS program defines requirements for the island’s end-state to satisfy applicable, related laws and regulations and will oversee the execution of the activities necessary for its closure and conveyance.

Due to the nature of scientific activities conducted at PIADC during its operation, it is necessary for the PICS program to collaborate with the New York State Department of Environmental Conservation (NYSDEC) and the USDA Division of Agricultural Select Agents and Toxins (DASAT) regarding the end-state determination of decontamination for the facility and island, prior to its conveyance by GSA.

1.2 Facility Description

PIADC refers to the 840-acre Plum Island as well as the Orient Point, NY facility which is approximately 9 acres. Brief descriptions of the major facility buildings which have supported the science mission at PIADC and will require terminal decontamination and/or validation of decontamination are provided below. Note that a significant portion of these biocontainment facilities are more than 50 years old.

· Building 101 – The majority of research, diagnostics and training conducted at PIADC occur within Building 101 biocontainment, which is approximately 200,000 square feet and includes Biosafety Level 3 (BSL-3) Enhanced, Biosafety Level 3 Agriculture (BSL-3 Ag), Animal Biosafety Level 3 (ABSL-3) laboratory and animal research facilities, and associated equipment and machinery spaces.

· Building 100 – Research has also been conducted in Building 100 in two Biosafety Level (BSL-2) laboratory suites (each approximately 2,200 square feet and located outside biocontainment).

· Building 102 – This biocontainment space (approximately 12,000 square feet) housed the former (no longer used) effluent thermal decontamination plant for treatment of waste generated in Building 101. (PIADC is in the process of decommissioning Building 102 and has begun development of a decontamination plan for this building.)

· Building 111 – This biocontainment space (approximately 18,000 square feet) was built several years ago to house the new, modern effluent decontamination plant for treatment of waste generated in Building 101.

· Building 257 – Building 257 (approximately 40,000 square feet) was constructed in 1911 and was used as a research laboratory for animal testing from 1954 to 1995. Building 257 has been unoccupied (vacant) for the last 24 years and the structure is compromised, exposing the interior to local weather conditions. (PIADC is in the process of developing a microbial sampling and analysis plan for this building to determine whether any further decontamination activities are required for this facility.)

Additional key supporting facilities include a 55,000 square foot administrative area within Building 100 (outside of biocontainment) which provides office space, meeting rooms, an auditorium, and a cafeteria. Approximately 70,000 square feet of additional support buildings (outside of biocontainment) provide space for systems, equipment, storage and other items and services to support the PIADC mission.

2. Scope of Services DHS requires senior and technical level expertise to support the PICS program at the PIADC. Specifically, this should consist of a range of expertise necessary to support the decontamination and closure of facility biocontainment structures and associated areas. This will entail task areas including, but not limited to: planning/executing scientific activities for decontamination methods and validation to include analyses involving various technologies, sampling approaches, monitoring methods, among others; translating results of method development and validation into plans for terminal facility decontamination; delivery of engineering planning, engineering design, and logistics to support implementation of facility decontamination methods and/or independent third-party review of such developed products; integration of scientific, engineering and other technical data in order to produce a comprehensive facility decontamination plan; operation of an on-island mobile laboratory for provision of independent third-party verification/validation testing of biological and chemical indicators (SCBIs, spore strips, integrators); and development of documentation of verification/validation results for review by regulatory bodies.

It is essential that the performer integrate across task areas, given that results determined and/or procedures developed in one task area will inform and, in some cases, define components of other task area services.

Each activity will be accomplished while working collaboratively with PICS Federal and contracted personnel, both onsite and offsite. These should include but will not be limited to DHS personnel at PIADC and at S&T headquarters, PIADC Center-Wide Support Program (CWSP) contractors performing the primary operations and maintenance functions at the facility, and additional contracted personnel providing various technical services. Detailed descriptions of these tasks are presented in the following pages for the expected five (5) Task areas of support, along with scoping assumptions to clarify the expected level of effort.

· Task 1 – Routine Operation of the Mobile Decontamination Laboratory

· Task 2 – Matrixed Support of Subject Matter Experts with Experience in Biological Decontamination at Facility-Scale

· Task 3 – Design and Execute Applied Scientific Activities to Enable Biocontainment Facility Decontamination

· Task 4 – Facility Modification Engineering, Planning, and Implementation

· Task 5 – Subcontract and Manage an Independent Third-Party Laboratory for Biological and Chemical Indicator Verification and Decontamination Sample Analysis

Task 1 – Routine Operation of the Mobile Decontamination Laboratory This includes all aspects of operating the DHS mobile decontamination laboratory from receiving, processing and reporting on samples to maintaining a clean and safe work environment. The mobile laboratory is expected to remain in operation throughout the Period of Performance and will support:

· Sampling & Analysis for B257

· Decontamination of B102

· Decontamination of B101/B111 The mobile laboratory is expected to be the primary laboratory for processing biological or chemical indicators to provide independent verification/validation of decontamination; however, a certain percentage of samples may need to be sent to an off-island laboratory for confirmatory testing and/or analyses beyond the capability of the mobile laboratory (see Task 5). Key tasks related to operation of the mobile laboratory are identified below.

1.1. Oversite of placement of biological or chemical indicators, to support decontamination verification or quality assurance (QA).

1.2. Biological or Chemical Indicator processing for interpretation of results or shipment to a third-party laboratory depending on the needed analysis (See Task 5). This may include SCBIs, spore strips, and preparation and performance of analytical testing of decontamination samples.

1.3. Documentation of sampling and results, including annotated photographs, to record and ensure that methods meet sampling and decontamination requirements. A report with all documentation will be provide quarterly (at a minimum) for review.

1.4. Providing a Monthly Report of Operations. This will include: any safety issues; type and number of samples processed; type and number of positive samples, potential cause of result, and actions taken to remedy, type and number of samples sent for 3rd party analysis; status of documentation; regulatory reports drafted for client review; regulatory concerns or issues.

1.5. Functional activities associated with routine operations of a BSL-2 operational space, including plans and methods to meet existing facility programs, as required.

Task 1 Scoping Assumptions

Task 2 – Matrixed Support of Subject Matter Experts with Experience in Biological Decontamination at Facility-Scale Access to a cadre of SME’s representing a range of expertise and experience in biological decontamination of facility-scale biocontainment laboratories is necessary to facilitate a range of PICS activities. These individuals should be available to work both onsite and remotely, using a labor mix deemed appropriate for the stated activities, along with additional tasks that may arise during the period of performance. However, it is assumed this Task 2 work would be primarily performed with offsite personnel in support of the Task 3 work, which would be primarily performed by on-site personnel.

Note: For this SME-level support, key interfaces with other Tasks in this Scope of Work are noted in the activities below. Key scope assumptions for this SME-level support (expected level of effort) are included in a table at the end of this section.

2.1 Review and development of facility decontamination plans, based on industry-best practices, applicable regulations, regulatory constraints, and prior experience with similar biocontainment facilities that previously utilized high-consequence infectious pathogens as part of programmatic scope, preferably those affecting livestock of economic importance. (This activity interfaces with Tasks 3.1, 3.5, and Task 4; specifically.)

2.2 Method development and validation to facilitate terminal decontamination processes for multiple surfaces and enclosures of facility-scale, involving high-consequence viral and bacterial pathogens. (This activity provides SME-level input to multiple Task 3 activities.)

2.3 Development and operation of quality assurance processes to ensure adequate performance of decontamination practices, i.e., to satisfy scientific and regulatory inquiry. These QA mechanisms shall assist with sampling, indicator selection, analysis methods, etc. both during the experimental validation development phase and during implementation.

2.4 Develop new, or review existing, permitting documents necessary for proposal, planning and/or performance of facility decontamination activities. For example, this could include documents needed to propose the use of terminal decontamination method(s) not previously approved by NYSDEC for use at PIADC.

2.5 Facilitate interactions with regulatory entities (NYSDEC, EPA) regarding permitting and operations of decontamination processes to include activities, but not limited to, preparation of talking points and PowerPoint presentations; preparing meeting agendas, minutes, and after-action reporting; and drafting formal communications for use by federal authorities engaged with regulatory entities.

2.6 Authorship of manuscripts for publication in peer-reviewed journals, in collaboration with federal colleagues, in order to share best practices from applied experience. Includes adherence to all applicable agency document review procedures (for public-facing materials) prior to public release. (This activity provides SME-level input/support to Task 3.3.)

2.7 Provide experience- and science-based recommendations and justifications for decontamination approaches chosen. (This activity provides SME-level input/support to Task 3.4.)

Task 2 Scoping Assumptions

· Review of the B102 Decontamination Plan

· Development of comprehensive Decontamination & Validation Plan(s) for B101 & B111 (i.e., this could be a single plan as these facilities are connected), including cost, schedule, and resource requirements.

· It is important to note that other work scopes within this SOW will define the technologies/methods that will be used for the decontamination & validation (Tasks 3.1 and 3.5) and will define any facility modifications needed to prepare the facility for decontamination (Task 4); i.e., the results of these other Tasks serve as inputs to the development of the overall decontamination & validation plan under this Task 2.1.

Task 3 – Design and Execute Applied Scientific Activities to Enable Biocontainment Facility Decontamination The purpose of this task is to establish and conduct the requisite scientific studies necessary to close knowledge gaps and enable an informed down-selection of available decontamination technologies for use in terminal decontamination of the PIADC facility. This work should also serve to inform future best-practices for biocontainment facility decontamination, so therefore should be shared in the form of peer-reviewed publications, and prepared in conjunction with DHS personnel. It is anticipated that, aside from facilitating the decontamination and closure of the PIADC, the results of these validation actions will also inform practices at other biocontainment facilities, including the NBAF.

This support is extremely important during the early stages of this project to allow detailed planning and methods to continue, both among related task areas, and in support of the overarching schedule for facility closure.

Note 1: It is anticipated that any validation activities involving use of live primary agent (e.g., FMDV, ASFV) at PIADC may only occur prior to transition of the facility scientific mission to NBAF (approximately in 2023-2024). Therefore, scientifically justifiable alternatives, such as studies utilizing surrogate, non-select agent target organisms, or options to utilize contractor-owned, international or other third-party facilities, could be included in the proposal and planning process to account for this eventuality.

Note 2: In general, these Task 3 activities shall be supported by SME-level support under Task 2. Specific interfaces between Task 3 and Task 2 activities are identified below.

3.1 Conduct a landscape analysis and synthesis of findings to include (1) best practices among existing decontamination technologies applicable to biocontainment facility scale, i.e., fumigants, surface cleaning/disinfection, use of heat/humidity, other approaches deemed relevant, (2) associated monitoring/validation methods, (3) peer-reviewed literature regarding applicable practices, (4) applicable, consensus standards for facility decontamination (academia, healthcare, biomedical, biocontainment, international, etc.), and (5) characteristics of the pathogen repertoire used historically at PIADC, to include those agents studied directly, any used as part of diagnostic or demonstrative activities, and commensal organisms from the animal species utilized. This analysis should draw on expertise of the performer’s SMEs involved, to include familiarity with and applicability of practices employed at other biocontainment facilities. It should also take into consideration PIADC-specific aspects beyond the agents studied, such as age and makeup of the facility, materials present, surfaces present, ambient climate conditions, etc. Each technology should be assessed in enough detail to inform future planning, and should include, but not be limited to, factors of efficacy, optimizing conditions, repeatability, cost, methods of validation, verification of conditions, penetration into surfaces, etc.

This task will result in a report and a presentation (PowerPoint) to be delivered/presented to DHS S&T and PIADC technical points of contact.

3.2 Use results of Task 3.1 to develop a plan for a series of validation activities to be conducted at PIADC. These activities should address gaps in knowledge regarding performance/efficacy of methods identified (decontamination and monitoring methods), specifically as applied to the PIADC terminal decontamination scope, and should be conducted in conjunction with federal personnel. They should be conducted with appropriate scientific rigor to serve as the basis for method selection, and support development of scientific publications, in order to share findings within the applied biosafety discipline. Therefore, appropriate controls, statistical analyses, and other processes necessary to validate findings are integral to this activity.

The plan, schedule and resource requirements for these scientific evaluations will be provided to DHS S&T for final review and approval.

It is anticipated that DHS will convene a panel of interagency biocontainment SMEs (“SME Panel”) to review the plan for this program of decontamination studies and may provide input regarding revisions/additions. Supporting equipment available at PIADC includes the following. An available equipment list will be provided as a technical exhibit.

3.2.1 Environmental chamber to evaluate effects of temperature and humidity on pathogen viability

3.2.2 Vaporized Hydrogen Peroxide Generator

3.2.3 Paraformaldehyde Fumigation Generating Equipment

3.2.4 Chlorine Dioxide Generator

3.2.5 Bio-contained space (including different finishes/materials) in which technologies may be evaluated for efficacy, while relevant parameters (humidity, ambient temperature, duration, air changes, etc.) may be controlled.

3.2.6 Sample surfaces of varying representative types for use as part of disinfectant validation.

3.2.7 A dedicated BSL-2 mobile decontamination laboratory to facilitate collection and manipulation of validation technologies (e.g., samples, BI’s, chemical indicators, etc.)

The responder should identify any additional equipment needed as envisioned for the plan, which DHS should provide to the contractor as Government Furnished Equipment.

3.3 The validation task will be executed once approved, coordinating with the DHS PIADC scientific staff. Results of each science-based evaluation will be presented to DHS S&T and PIADC technical points of contact in a report form. The SME panel will also review the results at this stage. Subsequently, publications will be prepared under their oversight. (SME-level support for development of reports and publications is covered under Task 2.6.)

3.4 Prepare formal recommendations as a result of the findings from Tasks 3.1 and 3.3. These recommendations will be presented to DHS S&T and PIADC representatives, so that a final down-selection of terminal decontamination methodologies (or a combination of same), along with monitoring methods, can occur. Work with PIADC and DHS S&T personnel to prepare and present these results to applicable regulatory authorities, as part of development of the terminal decontamination plan. (SME-level input/support for this task is provided by Task 2.7.)

3.5 Work collaboratively with the SME’s involved in Task 2 to translate the findings/results of these analyses into application as part of a decontamination plan. They will assist in development of specific protocols for utilization of down-selected technologies for decontamination and monitoring/validation. (SME-level support for this task is provided by Task 2.1 and it should be assumed that activities performed under Task 2.1 will lead this effort.)

Task 3 Scoping Assumptions

Assume the majority of work in developing the decontamination plan(s) is executed under Task 2.1.

Task 4 – Facility Modification Planning, Engineering and Implementation This task provides the engineering interface between the science aspects of closure and implementation of the decontamination techniques in the facility. This will require that the engineering effort is integrated with the science conducted, to ensure that methods developed are appropriately applied and required conditions can be attained in the facility.

4.1. Review decontamination scientific results and determine if facility modifications are required to implement recommended methods. This includes, but is not limited to, HVAC systems to provide the necessary temperature and humidity requirements, room/hallway re-configuration to support for decontamination/fumigation (e.g., sectioning off parts of the building with walls or bio-barriers), re-routing or isolation of ducting, electrical, plumbing, etc.

4.2. Provide the necessary engineering calculations and initial cost estimates to support the required modifications. This will include all regulatory, site and biological safety requirements.

4.3. Prepare presentations, reports, and other deliverables, as requested to demonstrate the need for the modifications. These materials may be required for site, DHS S&T or Regulatory review.

4.4. Develop design bases, scopes of work, plans, finalized estimates for schedule and cost, and logistics for implementation of the required modifications.

4.5. Provide engineering oversight during modifications to ensure identified requirements are met.

Task 4 Scoping Assumptions

Task 5 – Subcontract and Manage an Independent Third-Party Laboratory for Biological and Chemical Indicator Verification and Decontamination Sample Analysis As needed, an off-island laboratory will be required to provide analytical testing of samples to support:

· Verification/validation of biological and chemical indicators generated in decontamination activities as described in Task 1. These samples will primarily be composed of indicators generated during autoclave or fumigation activities.

· Verification/validation of solids, soils, or solutions generated in decontamination activities that require analytical testing, if testing is beyond the capabilities of the on-island mobile laboratory.

5.1 Collaborate with DHS personnel and the New York State Department of Environmental Conservation (NYSDEC) to ensure that the chosen independent, third-party laboratory is acceptable and meets their requirements for sample verification, data management, etc. In addition, ensure that in the interest of objectivity, the selected laboratory should be distinct and independent from laboratories currently used for similar purposes by the O&M contractor.

5.2 Ensure that the samples meet the receiving laboratory’s packaging, handling, and preservation requirements.

5.3 Analyze/interpret the results returned from the independent lab for the biological and chemical indicators sent offsite in support of generating certified reports of the results.

5.4 Manage the subcontract agreement to ensure timely result receipt of analysis results as well as other subcontract requirements.

Task 5 Scoping Assumptions

3. Notional Timeline for Scientific, Technical, and Engineering Support Tasks/Activities The high level “notional” timeline (see Figure 1) was assembled by the PICS Program Management Office (PMO) to assist contractors in comprehending the general scope of work and relevant key timelines related to both the science mission transfer from PIADC to NBAF, and the expected Select Agent Registration for the PIADC facility.

However, respondents to this Solicitation should utilize the Task Descriptions listed above and the planned Solicitation Question & Answer period to gain additional understanding of the scope of work in order to support their development of the estimated level of effort for each activity, the activity timelines, and durations in order to develop the proposed schedule for execution (see Section 4) and cost estimates.

Figure 1 – Notional Timeline

Additionally, Figure 2 provides a high-level summary view of the current PICS program schedule, identifying major program activities. As shown, the current Program schedule identifies PICS Program completion on or before December 2030 (“completion threshold”). However, key critical path activities are dependent on the date of the full transition of science from PIADC to NBAF. If there are delays in transitioning the science mission, then the PICS Program schedule may need to be adjusted accordingly. As such, the Notional Timeline (Figure 1) shows the potential for the Scientific, Engineering, and Support tasks/activities to extend into 2031 and 2032.

Figure 2. High-Level Summary View of PICS Program Schedule

4. Schedule Development The proposal should include a Project schedule that includes at a minimum all activities listed in this statement of work, as further described below.

· Task 1 can be shown as the duration required to equip and train personnel to operate the Mobile Laboratory, with operation of the lab planned for the remaining duration of the period of performance

· For Tasks 2, 3, and 4 provide an estimated timeline for each subtask, based the respondent’s understanding of the scope, and based on the respondent’s previous experience with similar work scopes to support facility level terminal decontamination and validation

2. Matrixed Support of SMEs with Biological Decontamination Experience at Facility-Scale

2.1 Develop and Review Facility Decontamination Plans

2.2 Method Development and Validation to Facilitate Terminal Decontamination Processes

2.3 Develop and Operate QA Mechanism to ensure Decontamination Performance

2.4 Develop New/Review Existing Permitting Documents

2.5 Facilitate Interaction with Regulatory Entities

2.6 Authorship of Manuscripts to Share Best Practices Developed

3. Scientific Activities to Enable Biocontainment Facility Decontamination

3.1 Conduct Landscape Analysis for Best Practices

3.2 Develop the Scientific Plan for Decontamination and Validation Activities

3.3 Execute Scientific Decontamination and Validation Activities Identified

3.4 Prepare Formal Recommendations of Findings

4. Facility Modification Engineering, Planning, and Implementation

· Task 5 can be shown as the duration to identify, select and complete contracting with the independent third-party laboratories, with use of these laboratories (as needed) planned for the remaining duration of the period of performance

5. Key Assumptions and List of Deliverables The following subsections highlight Key Assumptions and a List of Deliverables which Respondents should consider when developing the cost estimate for this Scope of Work.

Note that the list of deliverables is not intended to be a complete list for the full period of performance but is solely intended to provide Respondents additional insight for this Scope of Work. Respondents to this Solicitation should utilize the information in this Section and the planned Solicitation Question & Answer period to gain additional understanding of the Scope of Work in order to support their development of the estimated level of effort for each activity in order to develop their cost estimates.

5.1 Key Assumptions Related to Decontamination & Validation Planning For activities related to Decontamination and Validation planning, development, and oversight of execution, the following key assumptions should be used for the purposes of estimating costs:

Building 257

· A Sampling & Analysis Plan is currently being developed by PIADC in order to determine whether additional decontamination and validation activities in this building are needed after it has remained vacant (unused) for over 24 years and exposed to the environment. Accordingly, development of that Plan is not included in this Scope of Work.

· For the purpose of defining the level of effort to support work in B257, assume that no further decontamination and validation plans will need to be developed for this building.

· Oversight of execution of the Sampling & Analysis Plan (Task 2 & 3), including testing of samples in the Mobile Laboratory (Task 1) is included in this Scope of Work.

Building 102

· A Decontamination Plan is currently being developed by PIADC. Accordingly, the development of that Plan is not included in this Scope of Work.

· However, review of that Decontamination Plan, development of QA/QC processes for verification of proper execution of that Plan, and oversight of its execution (including any planned facility modifications) is included in this Scope of Work.

Building 101

· This Scope of Work includes development of the Decontamination & Validation Plan for this building, including development of engineering modifications to support the decontamination, such as, but not limited to, re-routing of electrical, chilled water, steam, HVAC, and communications, and sectioning off parts of this 200,000 square foot biocontainment building to facilitate decontamination, etc. (Task 4).

· Oversight of the engineering modifications and decontamination work is also included in this scope of work (Task 4).

· Placement and/or oversight of placement of biological indicators to support validation of terminal decontamination, as well as testing of these biological indicators in the Mobile Laboratory is included in this Scope of Work (Task 1).

Building 111

· This Scope of Work includes development of the Decontamination & Validation Plan for this building, including development of engineering modifications to support the decontamination, such as, but not limited to, re-routing of electrical, chilled water, steam, HVAC, and communications, and sectioning off parts of this 18,000 square foot biocontainment building to facilitate decontamination, etc. (Task 4). Note that B111 adjoins B101 and the Decontamination & Validation Plan for these two (2) buildings may be a single, integrated plan.

· Oversight of the engineering modifications and decontamination work is also included in this scope of work (Task 4).

· Placement and/or oversight of placement of biological indicators to support validation of terminal decontamination, as well as testing of these biological indicators in the Mobile Laboratory is included in this Scope of Work (Task 1).

Task 1 - Routine Operation of the Mobile Decontamination Laboratory

1.4 Routine Operation of the Mobile Decontamination Laboratory – Monthly Report of Operations

Task 2 - Matrixed Support of Subject Matter Experts with Experience in Biological Decontamination at Facility-Scale

2.3 Matrixed Support - Quality Assurance Mechanisms

Final Manuscript Deliverables due 90 days after agreement on topic and receipt of comments

2.7 Matrixed Support – Validation Activity Design

Task 3 - Design and Execute Applied Scientific Activities to Enable Biocontainment Facility Decontamination

Final Report and Presentation Draft due 90 days after inception and Final due 15 days after receiving comments

Final Report Per Plan Schedule included in 3.2

Final Report/Plan Draft due 90 days after submittal of Presentation in 3.4 Final due 15 days after receipt of comments

Task 4 - Facility Modification Engineering, Planning and Implementation

2 Final Presentations Deliverable due 15 days after assignment

Task 5 - Subcontract and Manage an Independent Third-Party Laboratory for Biological and Chemical Indicator Verification and Decontamination Sample Analysis

6. Special Conditions, Standards, Regulations & Third-Party Validation Performing work at the Plum Island Animal Disease Center (PIADC) requires integrated logistics with the operations on the island and involves specialized procedures. The following sections identify key requirements related to performance of the required scope of work.

6.1 Special Conditions

ONL requires the following conditions specific to the Scope of Services:

· Signed NDAs for work information provided, work performed, and decisions made

· The work is being performed at a US Government facility and all personnel associated with any contract or visit are subject to security requirements including, but not limited to, background checks, escorting, and various other requirements. Consideration of PIADC logistics, safety, and biosafety procedures must be included in performance of work

· Ability to work with DHS S&T ONL (PIADC and headquarters Federal personnel), SMEs and contractors to meet the requirements of the SOW

· Ability to work with the PICS team in presenting decontamination planning and procedures to state regulators

· Ability to work in close collaboration with other contractors who will be the independent performers of the physical decontamination work

6.2 Standards & Regulations

High Level Contract Quality Requirements, in accordance with FAR 52.246-11 are identified in the Contract. However, as noted above, performing work at PIADC requires adherence to specialized procedures, particularly with regard to execution of work within bio-containment. Accordingly, the bulleted list below identifies key standards and regulations, followed by PIADC, which will be required to be adhered to by the STENS contractor while executing this scope of work.

Regulatory Requirements

· 9 CFR § 121. Possession, Use and Transfer of Select Agents and Toxins

· 21USC § 113a. Establishment of research laboratories for foot-and-mouth disease and other animal diseases

· USDA Select Agent Registration Requirements

· New York State Regulatory Requirements

· 6 CRR-NY 201-8.3 New York State Air Resources

· 6 NYCRR Part 360 – Solid waste management Other voluntarily adopted sources/standards at PIADC

· CEN Workshop Agreement CWA 15793: Laboratory Biorisk Management

· ISO 35001:2019, Biorisk Management for Laboratories and other Organizations

· ANSI/ASSE Z9.11-2016, Laboratory Decommissioning

· ISO 9001:2015, Quality Management Systems – Requirements

6.3 Independent and Objective Audit, Verification, and Validation The Government has intentionally designed the requirements of the STENS effort to exclude the physical execution of terminal decontamination work, and separately procure that work. The STENS scope consists of the planning, coordinating, and validating of terminal decontamination activities. It does not include the actual performance of physical terminal decontamination; however, the STENS performer must closely plan and collaborate with the physical terminal decontamination contractor, to be successful.

DHS is required to avoid, neutralize, or mitigate potential significant organizational conflicts of interest on the part of prospective contractors so as to prevent the existence of conflicting roles that might impair a contractor’s objectivity in accordance with FAR Subpart 9.5. A significant aspect of the STENS contract involves the validation of terminal decontamination activities. DHS intends to ensure objectivity and protect the Government’s interests under FAR § 9.505–3 in the award of the contract.

Prior to awarding the contract to the apparent successful offeror, DHS will conduct an analysis to determine if a conflict of interest exists and whether any such conflict can be avoided or mitigated. Before determining to withhold award based on conflict of interest considerations, the contracting officer will notify the contractor, provide the reasons therefor, and allow the contractor a reasonable opportunity to respond. If the contracting officer finds that it is in the best interest of the United States to award the contract notwithstanding a conflict of interest, a request for waiver shall be submitted in accordance with FAR 9.503.

In addition, all activities at PIADC must comply with existing obligations, including statutory and other federal mandates, national and international standards (e.g., ANSI, ISO), and state regulatory requirements (e.g., New York Codes, Rules and Regulations), and should be consistent with validated scientific and industry best practices, including those related to independent and objective audit/verification/validation of terminal decontamination processes. This compliance is necessary to ensure acceptance of the terminal decontamination approach, both by regulatory agencies, and to withstand public scrutiny.

Information provided by interested parties should address plans or approaches for compliance with statutory and other federal mandates, national and international standards, validated scientific and industry best practices, and state regulatory requirements.

In addition to FAR Subpart 9.5, the required level of independence and objectivity in this procurement is defined in these applicable standards:

· ISO 9001:2015, Quality Management Systems – Requirements

· ISO 19011:2018, Guidelines for Auditing Management Systems

· ISO 14001:2015, Environmental Management Systems – Requirements with guidance for use

· ISO 35001:2019, Biorisk Management for Laboratories and other Organizations

· ISO 45001:2018, Occupational Health and Safety Management Systems – Requirements with guidance for use, and

· ANSI/ASSP Z9.11-2016, Laboratory Decommissioning 19 | Page image1.emf image2.jpeg