PIADC PICS STENS Site Visit Questions and Responses 20220731.pdf

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

DHS Responses to Contractor Questions on STENS Solicitation, from 6/29/2022 site-visit

1) There is a lot of activity…are there going to be OCI concerns?

There are contractual relationship concerns, but they are not necessarily OCI per se under FAR 9.505. National and international standards (e.g., ISO 9001, 14001, and 19011 and NQA-1), including those that PIADC has a commitment to follow, industry best practices, and state regulatory requirements are also being reviewed.

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 is essentially the planning, coordinating, and validating of decontamination activities. It does not include the physical terminal decontamination effort but must closely plan and collaborate with the physical decontamination contractor, to be successful.

All activities at PIADC must comply with existing obligations, including national and international standards and state regulatory requirements and should be consistent with industry best practices, including those related to independent and objective audit/verification/validation of the decontamination processes.

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

2) Comments on SOW – can they be submitted today?

Yes, as discussed at the site visit meeting.

3) Are the slides going to be available to use for the bid?

Yes, contractors will be provided a modified/public version of the presentation.

4) When will the RFP be released?

DHS plans to release a draft RFP in August and a final RFP approximately 30 days after that.

5) What will the format of the proposal be?

The draft RFP will provide format requirements.

6) What will the page limit be? How long will we have to respond? How will the RFP be released?

The draft and final RFPs will be released via SAM.GOV and directly to the Site Visit attendees. The draft RFP will include page limitations and response times. Given the use of previous RFIs, Site Visits, and a draft RFP, we are anticipating a 30-day response time for proposals.

7) Will there be OCI considerations regarding future performers?

The concern related to the performance of the physical terminal decontamination is described above in the response to Question #1.

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

8) If a prime contractor has an in-house laboratory how can that lab be considered “independent third party lab”? Isn’t that an OCI?

In such a case, it would be the responsibility of the prime contractor to provide their approach to comply with standards, best practices, or regulatory requirements and/or OCI mitigation that is acceptable to DHS. Any proposed approach must meet the requirements of, and be acceptable to, the NYSDEC.

9) Can a prime or sub both operate the mobile laboratory and perform independent validation of samples from task 5? Or is this considered an OCI? If this is an OCI, could it be mitigated with a “firewall” between task 1 and task 5?

Task 5 is separate from operation of the on-island mobile lab. As described in the SOW and in the presentation during the site visit, Task 5 is “Subcontract and Manage Independent Third-Party Lab for Biological and Chemical Indicator Verification and Decontamination Sample Analysis”

• Off-island, independent laboratory will be required to support:

o Confirmatory verification/validation of biological and chemical indicators generated in decontamination activities o Verification/validation of solids, soils, or solutions generated in decontamination activities (if testing is beyond capability of on-island mobile lab) i.e., it is expected that a certain percentage of samples may need to be sent to an off-island, independent laboratory for confirmatory testing and/or analyses beyond the capability of the on-island mobile laboratory.

10) Will the documents/drawings provided be considered FOUO and/or restricted? How can the contractor access this information? Is a CUI plan required?

DHS his looking into the feasibility of setting up a virtual reading room and/or use of access restriction tools within

SAM.GOV.

11) Could we get an updated schedule?

An updated schedule will be provided with either the draft/final RFP or other secure sharing method.

12) The draft SOW mentions monthly testing for up to 10 years. What is the purpose of the extended testing? Once the area is decontaminated and that decontamination is validated why would further testing be needed?

The schedule for testing to be completed during the Period of Performance will depend upon numerous factors, including when physical decontamination can begin subsequent to mission transfer, the decontamination approach to be applied, and the manner in which it is executed.

13) What is the expectation for terminal decontamination of retired equipment and are their locations inside or outside of the biocontainment areas?

Terminal decontamination of retired equipment will most likely not take place other than by destructive methods. If a determination is made regarding high value equipment that may have re-use, then it would be decontaminated by validated methodologies approved by New York State. There is no equipment located outside of biocontainment that requires decontamination.

Scientific equipment, other portable equipment, and materials will be removed after mission transfer but before terminal decontamination. Fixed equipment that is part of a ‘system’ will require decontamination and remain in place until execution of physical decontamination.

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

14) Will NBAF be performing FMDV work to support STENS if required after the transition?

This question is not pertinent to the solicitation.

15) Has GSA identified any third parties interested in acquiring PI? Would said third party have any input in decon requirements before acquisition?

GSA activities are not under the purview of the PICS Program. The only ‘third party’ that has any input decontamination requirements are the regulatory agencies – New York State Department of Environmental Conservation and the Federal Select agent Program.

16) Has PICS determined the risk tolerance of insurance underwriters for future insurability of the Plum Island assets that will be transferred?

This question is not pertinent to the solicitation.

17) Will DHS provide the equipment such as cameras and computer that will need to remain with “containment”?

The government will provide necessary equipment for use in “containment”.

18) Will DHS provide an IT infrastructure for the maintenance of documentation?

Only issued government computers may be used on DHS infrastructure. As the question may relate to the records management requirements, all work should be performed on government computers to the extent possible. All final records should reside on the government infrastructure.

19) Will all materials and equipment be removed from the facilities when the decontamination validation plans are being developed and verified?

Scientific equipment, other portable equipment, and materials will be removed after mission transfer but before terminal decontamination. Planning will be underway before mission transfer. Fixed equipment that is part of a ‘system’ will require decontamination and remain in place until execution of physical decontamination.

20) Will all buildings be available at the same time for decontamination, or will the cessation or work and occupancy be at differing points?

The buildings will most likely be available at differing points, however the schedule is still being developed, and will be influenced by the results of the work developed by the STENS contractor. It is highly likely that different sections of B101 will become available and will be available in a planned sequence to ensure no cross-contamination.

21) What is current animal population?

Not applicable to the solicitation.

22) Do you expect number of animals to change over the next year?

Not applicable to the solicitation.

23) The zones in the bio safety cabinet are zone 4 but room is zone 3?

That is correct...this is because there is no active manipulation of agent outside of the biosafety cabinet.

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

24) Does look like using sampling to clear the space for verification instead of surrogate.

It is up to the responder to define a technical approach, including the rationale for its selection, that would be inclusive of this decision.

25) Is there going to be molecular testing going on? Will there be PCR?

It is possible that there may be some lagging molecular biology activities (such as PCR) occurring in limited areas of PIADC, but these will be isolated from other areas of the facility where initial decontamination and sample collection activities may occur, such as within animal rooms.

26) No research under task 2- just under task 3- it’s a little confusing.

Active research is not within the scope of this solicitation. The decontamination technologies are already available, and this solicitation is looking for proposals to validate these existing technologies against the target pathogens and different substrates/surfaces for effectiveness.

27) Independent testing- can we do that testing in our labs or does it have to be done on site?

The independent testing will not be performed onsite. It is up to the responder to identify and justify their selection of the offsite capability to perform this testing and justify its independence.

28) Have you ruled out sterilizing the entire facility at once?

DHS has not ruled out any proposed strategy for decontamination and is looking for the STENS contractor to advise DHS as to their recommended best strategy for decontamination. It is up to the responder to define their technical approach, including the rationale for its selection, in response to the scope.

29) Wouldn’t it be true that the interior of duct or hepa filters be a zone 3?

It should be assumed that if a duct space or HEPA filter services a Zone 3 space, it is considered Zone 3. But if a HEPA filtered HVAC was put in place based on an assumed risk of potential pathogen release, then the duct work up to and including the filter would be treated as Zone 4.

30) What decon hepa filters what are you using?

PIADC currently has both Flanders and Camifil-Farr HEPA filters and housings on-site. PIADC performs HEPA filter decontamination in-house using formaldehyde gas fumigation.

31) All recent bio decons have required known surrogates. Is this planned?

It is up to the responder to define a technical approach, including the rationale for its selection, that would be inclusive

32) How will decontamination be validated. Sampling vs surrogates and substrates?

It is up to the responder to define a technical approach, including the rationale for its selection, that would be inclusive

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

33) What quantitative methods did you use to verify the zones?

Zone designations are based on local risk assessments for potential release of select agents based on the activity and/or processes occurring within that Zone.

34) Will mobile laboratory have PCR?

The responder should propose the capabilities that are most appropriate to be present in the mobile laboratory, based on their technical approach to the scope. The current equipment list that will be included in the mobile lab is specified in the response to Question #56. However, the lab has sufficient desktop space to support additional equipment if specified as needed by the STENS contractor.

35) RE: mechanical/ machine spaces: are the areas of the utilities on the “dirty” side considered zone 3 and 4?

Mechanical and machine spaces are designated as Zone 3. If the area services Zone 3, then it should be considered Zone 3; if the area services Zone 4, then it should be considered Zone 4.

36) Will the laboratories and spaces be cleaned and deconned following current processes/procedures/requirements before release to STENS?

The spaces will be left “broom-ready” following cleaning and the normal daily surface decontamination that currently occurs as part of normal good lab practices.

37) What existing technologies and/or equipment for decontamination are available on island? (Validated and unvalidated)

Virkon-S, Sodium hydroxide and formaldehyde gas are currently in use at the facility. Sprayer- balls located in air locks, as well as sprayer carts, are used for delivery.

38) Have spore-formers ever been used in any of the buildings on the island including B257?

No.

39) What is the current animal population at PIADC?

Not applicable this solicitation.

40) Will awardee/contractors have access to past biological sampling data?

To be determined with a justification.

41) What diagnostic activities are anticipated to be done at the mobile lab on site versus sending to a third party?

It is up to the responder to define a technical approach, including the rationale for its selection, that would be inclusive of this decision. The current equipment list that will be included in the mobile lab is specified in the response to Question #56. However, the lab has sufficient desktop space to support additional equipment if specified as needed by the STENS contractor.

42) What does provision of an independent third party verification/validation testing of biological and chemical indicators mean?

Through a subcontract or other defined mechanism to provide evidence of the capability, the performer should provide the capability to perform the service, as defined within the SOW.

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

43) Will the BSL2 laboratories in B100 be included in the decontamination planning?

Yes.

44) Will the mobile laboratory need to be certified to a testing standard?

No. It is anticipated that the third party independent laboratory will already satisfy a certified testing standard.

45) What was the basis for the density of sample placement to square feet of space to derive the approximately 200 samples per month for 10 years?

This is a planning estimate in order to facilitate comparison among offerors. It will be up to the STENS contractor to recommend the methodology for sample placement, as part of their technical approach.

46) Will photography inside the laboratory spaces of the indicators when placed be allowed? What approval will be required?

To be determined from proposed use...if approved these photographs will be the property of and controlled by DHS and will require a security review and approval for intended use.

47) Are risk assessments for each of the spaces to be decontaminated been developed? Will they need to be provided to the contractor?

Risk assessments were performed as part of the Zone designation process. If additional risk assessments are required based on the decontamination activities within the space, they can be developed and will be provided to the contractor.

48) Will the third party laboratory require a level of certification or registration?

49) Evaluation indicator from autoclaves is indicated. Is this only for the indicators generated by the mobile lab when they utilize the autoclave?

No. Indicators tested by the mobile lab include terminal decontamination indicators for the facility as well, not just indicators from autoclaved waste streams.

50) Will floor plan of mobile lab be shared?

Yes, will be provided as shown in the in PPT during the site visit.

51) Is there a BAS/BMS controlling the whole building or is each system separate?

The ventilation systems in most areas of B101 and B111 are controlled by the Building Management System (BMS).

52) Does B102 have any equipment still operable (fans, etc.)?

53) When will the mobile lab be on site and available for use?

It will be available prior to STENS contract award.

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

54) Will design documents for the mobile lab be shared as part of the RFP? This will be required to assess throughout.

Floor plan and equipment list will be available. See equipment list identified in response to Question #56.

55) Will lab photos be made available?

56) Will the mobile lab already be fully outfitted with instrumentation?

The mobile lab will be outfitted with the following equipment. If additional equipment is required, this should be identified in the respondent’s proposal.

• 3 incubators (BINDER Model #9010-0326)

• 3 Bio-Safety Cabinets (NUARE Model #NU-540)

• 1 Autoclave (YAMATO Model #SQ810C)

• 1 Refrigerator & Freezer (FRIGIDAIRE Model #FFHT1835V)

• 2 sinks with eyewash stations (1 in BSL-2 space; 1 in Entry Office space)

• Undercabinet Air Compressor

• 5 worktables in BSL-2 lab space; 3 worktables in Entry Office space

57) Will contractor be responsible for acquiring consumables?

58) What are the exterior areas (as needed) that are indicated in the SOW?

This scope should not be included in the cost estimate for support services, as it remains undefined at this point.

59) Will the mobile lab on island be provided with all primary containment, incubators, refrigerators, and freezers or will the contractor need to secure the equipment as part of the set up mobile lab?

The Mobile Lab will be equipped with incubators, refrigerators, and freezers and an autoclave. See equipment list in response to Question #56.

60) Will there be an area(s) for the controlled storage of supplies and consumables for the mobile laboratory? This may require ambient and refrigerated storage.

61) Will the mobile lab contain an autoclave for the destruction of samples and other laboratory generated waste? What other protocols will the lab need to follow for the handling of BSL2 laboratory waste on PIADC?

Yes. The STENS contractor will follow existing O&M procedures.

62) Are there design drawings available to the contractor?

Yes, all drawings pertaining to the buildings requiring decontamination will be made available to the STENS contractor after award. More information will be provided in the RFP.

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

63) Are there as-built drawings, design drawings or other physical documentation of B101? Are these in a CAD format. Are there equipment lists?

There are design and as-builts for the infrastructure and buildings. The newest building (B111) has revit/CAD files, while the older buildings have original USACE design documents plus revisions. Drawings will be made available after contract award. There are equipment lists that will be made available after contract award.

64) PFD and P&ID available for HVAC/air system and waste water? As builts?

See answers to Questions #62 and #63. Drawings will be made available after contract award.

65) As new technologies are developed over the 10 years can they be considered and evaluated?

New technologies can be considered.

66) What is the acceptable regulatory level for the release of the site to any public entity.

The intent of the STENS contract is to define, justify and plan a methodology for terminal decontamination that will achieve results that will be acceptable to regulatory authorities.

67) Will the draft decontamination plan for B102 be completed by DHS and provided to the performer for validation/verification or will the performer draft a new plan?

A decontamination plan for B102 is currently under development and will be provided to the STENS contractor to support their validation/verification of the decontamination. The STENS contractor will be responsible for developing decontamination plans for B101 and B111. Note that physical execution of any decontamination plans will be considered under a separate solicitation and proposal.

68) What level of clearance or registration will be required for staff performing activities under the contract? Will all require suitability and select agent clearance?

A full Security Suitability Background Check, along with a Select Agent Clearance, and enrollment within both the Personal Reliability Program and Occupational Health programs will be required.

69) Will a list of laboratories that the current O&M contractor uses be provided?

It is up to the responder to identify and justify their selection of the offsite capability to perform this testing.

70) Subtask 1.1 is about 200 biological and chemical indicators a total of about 200 or 200 each biological and 200 chemical?

Assume 200 total based on using both BIs and chemical emulators. It is expected that the exact number will vary;

however, this assumed number/volume has been provided for consistent estimation purposes among respondents.

71) Is there a distinction between 3.4 “…final down selection of terminal decontamination methodologies” and “final section of decontamination technologies?”

Yes. The down selection is the recommendation from the STENS contractor. The final selection will be made by DHS.

PROCUREMENT SENSITIVE INFORMATION. This document contains pre-decisional and/or deliberative process information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 522 (b) (5). Do not release without prior approval of the Department of Homeland Security Science and Technology Directorate (DHS S&T).

72) When will USDA provide the definitive 2 agents and 3 substrates to develop the decontamination plan?

It is up to the responder to define a technical approach, including the rationale for its selection, that would be inclusive of this decision. Those example quantities are provided in the SOW to enable development of a conceptual technical task and cost estimate.

73) Can DHS provide a list of analytical equipment to be provided (or to be acquired)?

It is up to the responder to define a technical approach, including analytical equipment needed as part of this solicitation. The equipment list currently included in the mobile lab is identified in the response to Question #56. If additional equipment is required, this should be identified in the respondent’s proposal.

74) Will the level of support for some reach back be better defined?

The capability for SME reach-back support (scientific and engineering) is a key element of the STENS procurement and level of effort of support will be as needed by the STENS contractor. This should be proposed by respondents as part of their technical approach.

75) Has there been a hazardous material assessment of the site and it the report available?

A Hazardous Materials assessment has been conducted...it is To Be Determined if the report can be shared.

76) Who will be responsible for packaging and shipment of samples to a third party lab? The shipper of record? Is there already a preferred method of procedure for shipment from PIADC that must be followed? Will refrigerants be available if needed?

Packaging, Shipping and Shipper of Record is part of operating the mobile laboratory. Existing procedures are in place;

however, it will be up to the STENS contractor to use the existing procedures or modify the procedures as needed. The laboratory has limited refrigeration and freezer capacity that can be used for shipping gel packs.

77) Are there any considerations from the Advisory Council on Historic Preservation (ACHP) that impact Task 4?

Not applicable to this solicitation.