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Request for Quotes Solicitation ID: RFQ-NIAID-22-2133694 Bldg. 33 BSL3 Autoclaves/Sterilizers This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedur... Request for Quotes Solicitation ID: RFQ-NIAID-22-2133694 Bldg. 33 BSL3 Autoclaves/Sterilizers This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-NIAID-22-2133694 and the solicitation is issued as a Request for Quotes (RFQ). This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2022-07 Effective August 10, 2022. The North American Industry Classification System (NAICS) code for this procurement is 339112 – Surgical and Medical Instrument Manufacturing with a size standard of 1,000 employees. The Product or Service Code (PSC) is 6640 – Laboratory Equipment and Supplies. The requirement is being competed as full and open competition, with a brand name or equal restriction, and without a small business set-aside. The government intends to award a firm-fixed-price purchase order to the responsible offeror as a result of this RFQ that will include the terms and conditions set forth herein. By submitting a quote, the offeror is accepting that all government terms and condition shall prevail over the award. By submission of a quote, the Offeror acknowledges the requirement that a prospective awardee shall be registered and viewable in the System for Award Management (SAM) database prior to award, during performance, and through final payment resulting from this solicitation (www.sam.gov). STATEMENT OF NEED The C.W. Bill Young Center for Biodefense and Emerging Infectious Diseases was initially commissioned in 2006. This special facility encompasses high containment biosafety level 3 (BSL3) research suites suitable for work with highly infectious pathogens. The new units must provide a physical method to disinfect and sterilize various biological wastes and other items by reaching and maintaining 121°C for at least 30 minutes with a pressure of at least 15 Psi. Must have the following cycle settings that require a password to launch. Liquid Cycle – for liquid media, non-flammable liquids, aqueous solutions, and liquid biological wastes. Solids or Dry Cycles – for glassware, dry hard items, metal items with porous parts, and other porous materials. Wrapped goods or Pre-vacuum cycle – for glassware that must be sterilized upright or can trap air, pipette tip boxes, sharps decontamination, biohazard waste decontamination in autoclave bags (which can be wet or dry). The existing BSL3 pass-through autoclaves for these high containment suites require replacement/upgrades (adding bioseals and associated alterations to support new units). Current requirement is to seek specific replacement/upgrades for rooms 1E08, 3E08, and 3E10. These autoclaves are now experiencing reoccurring issues and have hit their end-of-life stage. DIR intends to procure these three new autoclaves as the first phase of a multi-year approach to upgrading all of these units within the building. Additional phases to follow are planned for the Summer of 2023 and Summer of 2024 via separate procurement requests. Replacement and installation of these new autoclaves will incur a manufacturing lead time and must correlate with the ORF design-build project that was recently awarded. As such, this acquisition focuses solely on the first wave, which is being purchased with FY22 money and due to the lead time, will be replaced and installed in approximately Summer of 2023. See Attachment 1 – Statement of Needs The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for the brand name equipment manufactured by Getinge. GSS-R 6710 ARB-2 M4411, Qty – 3 (2 right side service and 1 left side service) B&R control system 10” color touchscreen HMI 4” fascia printer Biological sealing flange with lagged wall frame Effluent liquids open program Effluent WIT program Instrumentation above chamber on two sides Condensate return Chilled water recirculation Incoming media gauges Air and steam to door gasket C-rails Withdrawable shelf Top shelf Removal of existing Getinge units Rigging onsite and internal Installation and assembly of new Getinge units to include bioseal and equipment leveling Shipping and handling (FOB Destination) Warranty If offering equal equipment, country of origin and place of manufactured products, must be provided with quote. If quoting an equal product, you must show in your quote how the quoted equipment meets these qualifications: This statement of needs is for the procurement of three autoclaves capable of providing sterilization and decontamination as well as maintaining biocontainment for Building 33 Biosafety Level-3 (BSL3) Laboratories. The following features or criteria must be met: Must provide a physical method to disinfect and sterilize various biological wastes and other items by reaching and maintaining 121°C for at least 30 minutes with a pressure of at least 15 Psi. Must have the following cycle settings that require a password to launch. Liquid Cycle – for liquid media, non-flammable liquids, aqueous solutions and liquid biological wastes. Solids or Dry Cycles – for glassware, dry hard items, metal items with porous parts, and other porous materials. Wrapped goods or Pre-vacuum cycle – for glassware that must be sterilized upright or can trap air, pipette tip boxes, sharps decontamination, biohazard waste decontamination in autoclave bags (which can be wet or dry). Must include the following features: Double door. One door in the clean side and the other in the dirty containment area. Should be designed to be operated from both sides and in no case that both doors are open at the same time (Pass-through autoclave). Doors are fully automatic, electrically operated with safety features that prevent doors from closing if obstructed by an object. Floor mounted, recessed through high containment walls 460-480V, 3Ph, 60Hz power requirement 100-120V, 60Hz for the control systems. Two units with right side service One unit with left side service Control system that fully controls the machine and is developed according to GAMP guideline. Remote located control and electrical panels which will be 50’ away from the units. 10” color touch screen HMI on both load and unload sides 4” fascia printer Biological sealing flange with lagged wall frame, stainless steel, and bolted to wall. Seal must be 6mm thick Nitril rubber gasket material using stainless steel clamping bars, nuts, and lock washers. Must provide an airtight seal capable of preventing passage of airborne microorganisms between classified zones of the facility. Any necessary penetrations shall be through potted condulet fittings. HEPA filtration provided for pneumatic signals though the bioseal for decontamination of the door air system and piping to provide safe filter replacement. Gas tightness tests need to be performed on each installation to show no leakage through the sealing flange with pressure differential of 0.22psig. Usable chamber dimensions of 26” wide, 2612” high, and 3938” deep and equating to a chamber volume of 16 cubic feet. Condensate return connection to capture non-product contact steam. Chilled water recirculation connection to use chilled water to reduce potable water consumption up to 75%. Incoming media pressure gauges. Chamber and door plate made from solid high quality 316L stainless steel with internal surfaces highly polished to Ra<0.5µm (20µin). Supporting jacket made from 304 stainless steel. Door reinforcements made from corrosion protected carbon steel SA516 Gr60/EN10028-2 1.0425. Stainless steel mesh strainer to protect the drain port from blockage by debris. Sterilizer chamber insulated with chloride free mineral wool encased by rigid sheet aluminum cladding. Front fascia of sterilizer constructed of 304 stainless steel and designed to support frequent cleaning of external surfaces. Doors sealed with parylene coated silicone rubber gaskets with both air and steam capacity. Chamber leak rate test must be provided and meet regulatory standards. Effluent sterilization process to entrap potentially contaminated discharge until successful completion of the sterilization cycles. The unit must fit in the existing spaces which are 22.6 sqft and 4’-4 3/8” in depth. Hence the units must have following dimensions Wall frame height 78 78” Wall frame width 48” Wall frame depth 3’-3 38“ Chamber flange width 40 18” Control Panels installed above the chamber to create more space for servicing. Sterilizer net weight must not exceed 2194 lbs and 3549 lbs by hydrostatic test. Provide withdrawable shelves specifically designed for easy loading and unloading of the sterilizers without using external trolleys. Also, provide extra top shelf placed on top of the withdrawable shelf to give an extra level of products. Provide the following services Disconnect plumbing, mechanical and electrical services on the existing machines Remove and haul away existing units to be replaced Install and level new units Install bioseal that is industry tested. Commission new units and provide necessary documentation including warranty information. Onsite training for staff and technicians. Provide details on how the training will be provided: mode and duration of training, learning objectives and outcomes, learning materials provided, and contributions to SOP modifications. Program software – Transfer user information such as names and passwords from old units to the new units. Customize software to require user password after selecting cycle and before starting the cycle. The timeframe the units must be delivered and installed is between May 2023 and August 2023. This is the time that the BSL3 suites are shut down for maintenance to fulfill regulatory requirements. Each disconnect and new installation needs to be fully completed and commissioned within three weeks. QUOTING REQUIREMENT All elements below must be included in the quote for your quote to be considered responsive: If not brand name, documentation to prove how the “of equal” model/part meets the salient physical, functional, or performance characteristic specified in this solicitation. Country of Origin Place of Manufacture Estimated date of delivery Estimated shipping fees PERIOD OF PERFORMANCE Delivery is requested as soon as possible. Estimated lead time for delivery is 60-90 days from date of award which is estimated to be September 30, 2022 through December 30, 2022, if not sooner. SHIPPING/DELIVERY INSTRUCTIONS Delivery location is 33 North Drive, Building 33, Bethesda, MD 20892. The Loading Dock is at semi-truck height. If the delivery truck is low, a lift gate is REQUIRED for pallet shipments or packages over 50 pounds. The Loading Dock hours are as follows: 7:00 am – 4pm pm EST, Monday through Friday except for Federal Holidays. FOB: Destination. All equipment delivered shall contain a Packing Slip (with serial numbers when applicable). Please contact Benson Maloba to coordinate at (240) 306 5512. INSTRUCTIONS All interested offerors shall provide a quote for the requirement as outlined in Attachment 1 – Statement of Needs (SON). The Government may evaluate only those quotes that fully meet the requirements as outlined in the SON and BOM and respond to the instructions and requirements below. Failure to furnish a full and complete quote as instructed may result in the Offeror’s response being considered non-responsive and will therefore be eliminated from further consideration and award. Quotes are due by 1:00pm EST on September 22, 2022. Quotes must be emailed to Jillian Marconi, Contracting Officer, at Jillian.Marconi@nih.gov. Late quotes will not be considered. All responsible sources may submit an offer that will be considered by this Agency. Any questions or concerns regarding this combined synopsis/solicitation should be emailed to Jillian.Marconi@nih.gov. EVALUATION NIAID will evaluate quotes to determine the best value to the government. NIAID will make that determination based on technical acceptability, price, and past performance. NIAID will evaluate price only for those quotes which are rated as technically acceptable. In the event quotes are evaluated as technically equal, price will become a major consideration in selecting the successful Offeror. Quotes which merely offer to conduct a project in accordance with the requirements in the Statement of Needs will not be eligible for award. The contractor must demonstrate in their own words in their quote how they will provide for the supplies including installation. SPECIAL NOTICE TO OFFERORS Offerors are advised that the Government may share your information with non-government personnel who are assisting with the evaluation of quotes. The exclusive responsibility for source selection will reside with the Government. By submitting your quote, you will be consenting to disclosure of your quote to non-government personnel for purposes of evaluation. ELECTRONIC INVOICING The successful offeror may submit an invoice once a shipment is delivered. NIAID will only accept invoices for units that have been delivered to NIAID. NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). The Contractor shall submit invoices to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving official until the Contractor has been notified of its transition to IPP. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment on the website at https://oamp.od.nih.gov/DGS/DGS-workform- information/attachment-files. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer. REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (SECTION 889) All offerors shall have current documentation showing representation of compliance with Section 889 provisions. Prior to award of delivery order resulting from solicitation, quoters shall be prepared to provide copy of section 889 compliance if requested by the Contracting Officer. SECTION 508 Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities. Vendors must identify whether a quoted Information and Communication Technology (ICT) product or service is compliant with the Section 508 accessibility standards at 36 CFR 1194. The quote must also identify where full details of compliance can be found (e.g., vendor's website or other exact location.) For more information on Section 508 standards visit https://www.section508.gov/. PROVISIONS AND CLAUSES The following Federal Acquisition Regulation (FAR) provisions and clauses are hereby incorporated by reference: The following Federal Acquisition Regulation (FAR) provisions and clauses apply to this acquisition: FAR 52.203-18 – Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements – Representations (Jan 2017) FAR 52.204-7 – System for Award Management (Oct 2018) FAR 52.204-13 – System for Award Management Maintenance (Oct 2018) FAR 52.204-16 – Commercial for Government Entity Code Reporting (Aug 2020) FAR 52.204-18 – Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.204-21 – Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) FAR 52.204-24 – Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 – Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.209-7 – Information Regarding Responsibility Matters (Oct 2018) FAR 52.211-6 – Brand Name or Equal (Aug 1999) – FULL TEXT FAR 52.212-1 – Instructions to Offerors – Commercial Products and Commercial Services (Nov 2021) FAR 52.212-3 – Offeror Representations and Certifications – Commercial Products and Commercial Services (May 2022) FAR 52.212-4 – Contract Terms and Conditions – Commercial Products and Commercial Services (Nov 2021) FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Products and Commercial Services (May 2022) FAR 52.232-25 – Prompt Payment (Jan 2017) FAR 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Nov 2021) FAR 52.242-15 – Stop-Work Order (Aug 1989) FAR 52.252-2 – Clauses Incorporated by Reference (Feb 1998) The following Department of Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses apply to this acquisition: HHSAR 352.203-70 – Anti-lobbying (Dec 2015) HHSAR 352.208-70 – Printing and Duplication (Dec 2015) HHSAR 352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR 352.223-70 – Safety and Health (Dec 2015) HHSAR 352.224-71 – Confidential Information (Dec 2015) HHSAR 352.232-71 – Electronic Submission of Payment Requests (No Date) – FULL TEXT HHSAR 352.239-73 – Electronic and Information Technology Accessibility Notice (Dec 2015) HHSAR 352.239-74 – Electronic and Information Technology Accessibility (Dec 2015) LIST OF ATTACHMENTS Attachment 1 – Statement of Needs (SON)