54-- Pre-engineered USP-800 compliant clean room

This is Sources Sought announcement only this is not a Request for Quote. The purpose of this notice is to conduct market research and obtain information from qualified vendors with special interest. No solicitation is being issued at this time. This notice shall not be construed as a commitment by the Government to ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. All responses must be received by Friday, August 24, 2018 by 4:00PM (EST) to the point of contact listed below. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The U.S. Department of Veterans Affairs, Network Contracting Office 2, and the VA Hudson Valley Healthcare Castle Point, NY anticipate a purchase order for the following item: Items: Pre-Engineered Clean Room required to comply with USP-800 Standard. The appropriate NAICS Code is 333312. Interested vendors are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract. A formal RFQ may be issued upon receipt of information pertaining to this Sources Sought Notice. If you are capable of providing the required item, please send your responses via email NLT Friday, August 24, 2018 by 4:00PM (EST), to Sam DeMuzio, Contracting Officer, at contact@example.gov. Responses to this notice shall include the following: (a) company name, (b) address, (c) socio-economic status, (d) point of contact, (e) phone, fax, and email, (f) DUNS number, (g) Cage Code, (h) Tax ID Number, and must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor and provide the commodities described below. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application (ORCA). Additionally, all Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. Requests for information and resultant responses shall be submitted directly to the contracting officer, Sam DeMuzio at contact@example.gov. NO TELEPHONE CALLS WILL BE ACCEPTED. PURPOSE. The VA Hudson Valley Healthcare Castle Point, NY requires temporary relocation of Sterile and Non-Sterile Compounding to USP-800 to building 18 at Castle Point to the ground floor. This will require the assembly of a clean room with Ante room, Sterile and Non-Sterile Compounding rooms. STATEMENT OF WORK Temporary relocation of Sterile and Non-Sterile Compounding to USP-800 At Castle Point Background This project requires temporary relocation of Sterile and Non-Sterile Compounding to USP-800 to building 18 at Castle Point to the ground floor. This requires the assembly of a clean room with Ante room, Sterile and Non-Sterile Compounding rooms. Objectives The Objective of the acquisition is to obtain parts and material and specifications detailing of the clean room required to comply with USP-800 standard. These parts and material will be used to assemble a temporary clean room for compounding of medicines. Period of Performance The period of performance for design shall be 60 days from Notice to Proceed. Place of Performance / Place of Delivery The place of performance for this contract is VA Hudson Valley Healthcare Castle Point, NY Scope or Tasks The manufacturer shall provide the required material and equipment to fulfill the attached design Area of work.pdf for a modular clean room for hazardous Drug compounding area, USP 800 compliance to be assembled on site at the basement of building 18 at castle point. The cleanroom shall contain an Ante ISO7 Positive room, a Buffer ISO7 negative room for HDs and a Buffer ISO7 positive for non-HDs room. The cleanroom must be pre- engineered and comply with USP-800 compounding Modular assembly which *includes but is not limited to the following: Complete Fan Filter Unit, HEPA controlled by the included Tier 2 Environmental Control System with touchscreen interface and data-logging capabilities Night Service Switch LED Light Panel Stainless steel wall structure bolts together and panels snap-in-place Cleanable sealed ceiling system Control Panel (Hardware/Software) Door, Swing, Single. Outlets, Duplex, 120V Electrical services connections & outlets Plenums for negative pressure room Exhaust plenum provides flanges for connection to the existing in-house exhaust system. Connection point for the facility utilities (AHU supply/exhaust & plumbing & electricity) Removable service panel(s) to HDs and non-HDs to facilitate the C-PECs insulation. *Please be advised, this is not a comprehensive list and other equipment and materials may be required to meet USP 800 compliance requirements which the manufacturer must provide and include in their proposed pre-engineered clean room. The manufacturer shall submit approved drawings to VA, seeking VA approval prior of manufacture of the cleanroom. The manufacturer shall submit schedule of manufacture and delivery no more than 6 to 9 weeks. The manufacturer shall provide specialized crew(s) to assemble the modular unit on site right after parts delivery. Areas of Work (attachment): Included is a drawing titled Area of work.pdf for reference. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) N/A Security The manufacturer shall obtain day passes for any site visits from the police station. If personnel from the manufacturer are expected to be on site more than five (5) days (cumulative) during the design, they shall file paperwork to obtain a permanent ID for the station. Necessary paperwork can be obtained from the COR. The manufacturer personnel who intend to take photos must inform the COR, at least 48 hours ahead to time, of such intentions. Safety Codes / Certification / Licensing The manufacturer shall comply with all codes as described above, as well as codes customarily applied in VA construction jobs such as NFPA, OSHA, VA Design Guides and Manuals, etc. Labs used by the manufacturer shall be licensed as required by any applicable governing agencies, and their certifications and licenses shall be included in the engineering reports. Travel No travel for government employees as a result of this project is anticipated. Employees of the manufacturer will be required to travel from their place of business to the place of performance indicated above for the purposes of field investigations, design reviews, pre-construction meetings, interim and final inspections, and closeout documentation preparation. Special Material Requirements No special materials are anticipated for this contract. Any Other Requirements unique to the solicitation. None