70RSAT22RFI000003 - PICS RFI - Draft SOW - 20211210.pdf

PIID: 70RSAT22RFI000003

DRAFT SOW to Accompany RFI for Scientific, Technical and Engineering Capabilities to Support Decontamination and Closure of a Major Biocontainment Facility

Task 1- Routine Operation of the Mobile Decontamination Laboratory

This includes all aspects of operating the mobile decontamination laboratory from receiving, processing, and reporting on samples to maintaining a clean and safe work environment.

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

• Placement/oversite of placement of biological or chemical indicators, to support decontamination verification or quality assurance.

• Biological or Chemical Indicator Processing for interpretation of results or shipment to a third-party laboratory depending on the needed analysis. This may include SCBIs, spore strips, and preparation and performance of analytical testing.

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

• Monthly Report of Operations, this will include:

o Any safety issues o Type and number of samples processed o Type and number of positive samples, potential cause of result, and actions taken to remedy o Type and number of samples sent for 3rd Party Analysis o Status of Documentation o Regulatory reports issued o Regulatory concerns or issues.

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 technical activities. These individuals should be available to work both at a government site and remotely, using a labor mix deemed appropriate for the stated activities, along with additional tasks that may arise during the period of performance.

• Development and review 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.

• Development and oversight of execution of terminal decontamination processes for multiple surfaces and enclosures of facility-scale, involving high-consequence viral and bacterial pathogens.

• Development and oversight of quality assurance mechanisms to ensure adequate performance of decontamination practices, i.e., to satisfy scientific and regulatory inquiry

• Develop new, or review existing, permitting documents necessary for proposal, planning and/or performance of facility decontamination activities.

• Facilitate interactions with regulatory entities (State, Federal) regarding permitting and operations of decontamination processes (to include preparation of talking points and PowerPoint presentations; preparing meeting agendas, minutes, and after-action reporting; drafting formal communications for use by federal authorities engaged with regulatory entities, etc.)

• Authorship of manuscripts for publication in peer-reviewed journals, in collaboration with federal colleagues, to share best practices from applied experience. Includes adherence to all applicable agency document review procedures (for public-facing materials) prior to public release.

• Provide experience- and science-based recommendations and justifications for decontamination approaches chosen.

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 a large-scale biocontainment facility. These studies should also serve to inform future best-practices for biocontainment facility decontamination, and therefore should be shared in the form of peer-reviewed publications, prepared in conjunction with federal personnel. It is anticipated that, aside from facilitating the decontamination and closure of the subject facility, the results of these studies will also inform practices at other biocontainment facilities. Note: It is anticipated that any experimental activities involving use of live primary infectious agents at the subject facility may only occur prior to transition of the facility scientific mission.

Therefore, studies utilizing surrogate, non-select agent target organisms should be included in the planning process to account for this eventuality.

• 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 the subject large-scale biocontainment facility. 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 facility-specific aspects beyond the agents studied, such as its age and makeup, 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.

• The results of the previous task will be used to develop a plan for a series of scientific studies to be conducted at the subject facility using available equipment. Some of these experiments may be performed offsite, as long as it would be more cost-effective, and equivalency can be demonstrated to conditions at the subject facility. These experiments should address gaps in knowledge regarding performance/efficacy of methods identified (decontamination and monitoring methods) 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, to share findings within the applied biosafety discipline. Therefore, appropriate controls, statistical analyses, and other processes necessary to validate findings are necessary. The plan, schedule and resource requirements for these scientific studies will be provided to the government for final review and approval. Supporting equipment available at the subject facility includes the following. The responder should identify any additional equipment needed as envisioned for the plan.

o Environmental chamber to evaluate effects of temperature and humidity on pathogen viability o Vaporized Hydrogen Peroxide Generator o Paraformaldehyde Fumigation Generating Equipment o Chlorine Dioxide o 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.

o Sample surfaces of varying representative types for use as part of disinfectant studies.

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

• Studies will be executed once approved. Results of each scientific study will be presented to federal technical points of contact in a report form. Subsequently, publications will be prepared under their oversight.

• The performer will prepare formal recommendations as a result of the findings from Task 3. These recommendations will be presented to federal representatives, so that a final down-selection of terminal decontamination methodologies (or a combination of same), along with monitoring methods, can occur. It is anticipated that the performer will work with federal personnel to prepare and present these results to applicable regulatory authorities, as part of development of the terminal decontamination plan.

• The Contractor shall work collaboratively with others involved in supporting Task 2 to translate the findings/results of these analyses into application as part of a decontamination plan. This collaboration may include but is not limited to other contractors and Federal staff. The Contractor shall assist in development of specific protocols for utilization of down-selected technologies for decontamination and monitoring/validation.

Task 4– Facility Modification Engineering, Planning and Implementation Services

• Review decontamination scientific results and determine if facility modifications are required to implement recommended methods. This requires a thorough understanding of the current facility infrastructure. This includes, but is not limited to, HVAC systems to provide the necessary temperature and humidity requirements, and room/hallway configuration to support for decontamination/fumigation.

• Provide the necessary calculations and engineering and costs to support the required modifications. This will include all regulatory, site and biological safety requirements.

• Prepare presentations, reports and other deliverables, as requested to demonstrate the need for the modifications. These materials may be required for site, senior federal personnel, or Regulatory review.

• Develop design basis, scope of work, plan, estimates and logistics for implementation of the required modifications.

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

Task 5– Subcontract and Manage an Independent Third-Party Laboratory for Biological and Chemical Indictor Verification

This laboratory, separate and independent from the mobile laboratory described in Task 1, will provide analytical testing of samples to support verification/validation of biological and chemical indicators generated in decontamination activities. These samples will primarily be composed of indicators generated during autoclave or fumigation activities.

• Collaborate with Federal and State regulatory personnel to ensure that the chosen independent, third-party laboratory is acceptable and meets their requirements for sample verification, data management, etc.

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

• Analyze/interpret the results from biological and chemical indicators chosen as part of decontamination process monitoring and provide certified reports of the results.

• Manage to the contract to ensure timely result receipt and to meet subcontract requirements.

Task 6– Subcontract to and Manage Independent Third-Party Laboratory Decontamination Sample

This laboratory, separate and independent from the mobile laboratory described in Task 1, will provide analytical testing of samples to support verification/validation of solids, soils, or solutions generated in decontamination activities that require analytical testing.

• Collaborate with Federal and State regulatory personnel to ensure that the chosen independent, third-party laboratory is acceptable and meets their requirements for sample verification, data management, etc.

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

• Analyze/interpret the results from the analytical testing and provide certified reports of the results.

• Manage to the contract to ensure timely result receipt and to meet subcontract requirements