SOURCES SOUGHT
23 -- Mobile Laboratory Systems - Package #1
- Notice Date
- 12/20/2012
- Notice Type
- Sources Sought
- NAICS
- 336999
— All Other Transportation Equipment Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1113156
- Archive Date
- 1/24/2013
- Point of Contact
- Yolanda T. Peer, Phone: 8705437479, Jerry Martin, Phone: 870-543-7990
- E-Mail Address
-
yolanda.peer@fda.hhs.gov, jerry.martin@fda.hhs.gov
(yolanda.peer@fda.hhs.gov, jerry.martin@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notification for Microbiology Mobile Laboratory Systems (MLS) MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Office of Regulatory Affairs (ORA) requirement for four (4) Microbiology Mobile Laboratory Systems (MLS) to include post-warranty maintenance of these systems. This is a sources sought determine the availability and capability of small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer. The associated North American Industry Classification System (NAICS) Code is- 336999 - All Other Transportation Equipment Manufacturing; Small Business Size Standard is 500 employees. Background: The FDA requires four (4) MLS that have the comprehensive capability for in-field operations to test and analyze food commodities. The MLS must be designed and engineered to be immediately deployed as a first responder to protect against, respond to, and recover from emergency outbreak situations to any location, and in any weather condition within the continental United States. The MLS must be self-sustainable and able to operate without additional site utilities and services. The lab shall include on board electrical generators, supply and waste water tanks and the ability to decontaminate laboratory waste. The MLS shall provide multiple mission capabilities including in-field surveillance and laboratory surge-capacity, augmenting existing fixed laboratories. Specific requirements are as follows: Laboratory Trailer Construction: • Four laboratory trailers shall meet current US Department of Transportation (DOT) requirements. The MLS shall not exceed 53 feet in overall length, 102 inches in overall width and be less than 13 feet 6 inches in overall height (from road surface). • Exterior lighting and markings of mobile lab trailers shall meet DOT requirements and the electrical connection to the towing engine/tractor shall be made with a "glad-hand" connector. These performance requirements do not include the supply of the towing tractor. The mobile lab trailers will be constructed with necessary lightings and markings for towing the trailers to deployment sites. • The Mobile Laboratory shall be provided with a king pin capable of being towed by any commercially available towing engine/tractor with a fifth wheel. • The Mobile Laboratory shall be provided with standard air brakes with connection to the towing engine/tractor using a "glad-hand" connector. • The Mobile Laboratory frame shall be engineered and manufactured for the calculated loads, and axles shall be sized and placed for the projected trailer weight. • Air-ride suspension developed for transport of sensitive analytical equipment shall be used. • Trailer floor supports shall be steel and/or aluminum with no wood to be used in construction. Selection of aluminum or steel will be based on heavy equipment placement. • Exterior walls and roof shall be 0.090" thick aluminum and shall be painted white. • Each trailer shall have hydraulically operated leveling jacks installed. Leveling jacks shall allow safe setup of connections and walkways between the trailers. • Trailer to trailer connection walkways shall be weatherproof and maintain the laboratory interior environment. Once on site, the trailers shall be parked side by side (based on final design) and exterior doors and walkways shall allow the movement of personnel and materials from one trailer to the next without being exposed to the external climate. • Stairs and platforms for quick set up shall be provided and stored for minimal handling. • Exterior lighting (scene lighting, as opposed to drive lighting) shall be provided above each entry door and on both, the front and rear of each trailer. • Exterior lighting and markings of mobile lab trailers shall meet Department of Transportation (DOT) requirements and electrical connection to the towing engine/tractor and shall be made with a "glad-hand" connector. • Storage bays shall be provided and sized to fit auxiliary components as well as consumables for laboratory operations. Bays shall be insulated and heated to protect from freezing. • Slide-outs to increase laboratory interior space shall be sized and placed based on interior space plan/design. Slide-outs shall be operated with commercial grade electrical drive and shall have a manual back up system in the case of power loss. Slide-outs shall have dual seals to maintain the interior lab environment while in transport and extended. MLS Interior Construction: • The MLS flooring shall utilize Armstrong Medintech vinyl sheet commercial flooring; heat sealed providing a completely sealed surface. It shall be coved up the walls a minimum of four inches to contain spills and allow for routine wash-downs, sanitization and gas decontamination. Armstrong Medintech vinyl sheet provides a heavy-duty, long lasting work surface that also allows the movement and setup of heavy equipment. • Sub floor shall be aluminum. No wood shall be used in floor structure. • The interior walls and ceiling of the MLS shall be Arcoplast wall panels. This will provide for an interior with minimal seams. Corners will be coved for ease of cleaning. Arcoplast wall and ceiling panels allow for complete washdown, sanitization and gas decontamination of the interior space. Arcoplast shall be utilized because it is available in sheets up to 40 feet in length; allowing for a, close to, seamless wall surface. Arcoplast will not crack or damage easily due to the demanding road conditions. • Laboratory casework and furniture shall be constructed of powder-coated aluminum and engineered to meet the rigors of transport and meet trailer weight restrictions. • All countertops shall be constructed of stainless steel with marine edges and backsplashes to contain spills. Countertops shall be seamless for each casework grouping. This allows for increased clean-ability and sanitization. • Countertops with shock absorbing suspension (floating table) are required for semi-permanent placement of sensitive analytical equipment. This allows for analytical equipment to remain on countertops during laboratory transport. • Analytical equipment shall be secured to the floating table with specially developed load-locks. The load-locks allows for fully adjustable placement of the equipment on countertops as well as adjusting for different types of equipment. The load locks shall be stainless steel and allow for cleaning and sanitization. • Custom designed casework is required to accommodate floating table countertops. • Cabinets shall be provided for the secure storage of items during transport. Cabinet placement shall be determined during preliminary design (a process that occurs with the manufacturer (designers and engineers) after the contract has been awarded to discuss the specifics regarding the layout to meet the customer's needs on the final construction of the MLS). The preliminary design meeting shall take place within 60 days of contract execution. • Sinks shall be seamlessly welded into stainless steel countertops. • Each sink shall be provided with an emergency eyewash/drench hose/shower. • Lighting shall be provided with sealed housings. Lights shall be spaced to provide at least 75 foot candles of illumination on laboratory work surface. Mechanical: • Each mobile laboratory trailer shall have its own centralized Heating, Ventilating and Air Conditioning (HVAC) system capable of maintaining an interior working environment of 23°C, with external temperatures from -30°C to 40°C. • Laboratory ventilation/air exchange rates shall be provided to meet current industrial hygiene requirements with an 8 Air Change per Hour (ACH) minimum during occupied operations. • Engineering of the HVAC system shall be reviewed by a Professional Engineer (P.E.) with relevant mobile laboratory, Heating, Ventilating and Air Conditioning and High-Efficiency Particulate Air (HVAC/HEPA) air filtration experience. • HEPA filtration housing and individual HEPA filters shall be scan tested prior to delivery. Validation reports shall be provided. • Laboratory exhaust ductwork shall be helium leak tested and pressure decay tested prior to installation. • Exhaust HEPA filter housing shall be bag-in/bag-out thus allowing for clean and safe replacement and disposal of HEPA filters. Filter housings shall allow for in-place filter leak testing and be supplied with gas decontamination ports and isolation dampers. Filter housings shall be helium leak tested and pressure decay tested. Electrical: • The MLS shall have one diesel electrical generator sized to operate all of the trailers. This generator shall be mounted within one of the trailers and shall be provided with an additional sound and vibration shielding. • Backup generators shall be installed on each of the mobile lab trailers providing the capability of single trailer deployment. Diesel fuel backup generators shall be installed on each of the mobile lab trailers providing the capability of single trailer deployment. • Marine grade electrical panels and sub-panels shall be installed in each lab trailer. Only marine grade wire and connectors shall be used. • Shore power electrical cable connection points and trailer to trailer electrical cable connection points shall be provided. Cables shall be provided with the MLS and should be capable of providing 100 amp service, at minimum. • Low voltage electrical lines shall be separated from high voltage electrical lines in order to minimize electrical interference. • Low voltage lines (data, security and communication) shall be installed in a surface mounted "raceway" minimizing the penetrations in the wall panels. • Digital Video Recording (DVR) security camera system shall be installed with a minimum of four (4) cameras on each trailer. Two (2) cameras shall be installed on the exterior and two (2) cameras shall be installed on the interior with final locations to be assigned during the preliminary design process. • The MLS shall be pre-wired with network CAT 6 cable and include data ports, patch panel, network switch and rack mount enclosure. Data system shall be designed to support client Laboratory Information Management Software (LIMS) system. The LIMS system is used to track and log all data related to the introduction and analysis of samples brought into the MLS. The current FDA LIMS package will be installed (by FDA) on FDA provided computer workstations and require CAT 6 cabling to interface between trailers. This data system shall connect the multiple trailers. • Data cables shall be certified with a Fluke cable analyzer. A report shall be provided at the Factory Acceptance Testing (FAT) (a customized testing procedure for different types of systems that shall be executed before the final installation). Plumbing: • Supply and waste water tanks shall be provided on each trailer. Tank sizes will be determined based on each trailers consumption requirements. Each tank shall have a minimum capacity of 50 gallons. A separate Black water tank and related pumps shall be provided on the MLS, including the Unisex restroom. • Waste water tanks shall have provisions for liquid decontamination and procedures for effective effluent decontamination, based on tank volume, shall be provided. • Water tanks shall be heated to prevent from freezing. • Supply water shall be filtered before entering tanks. • Supply water tank for the double door must be properly sized and meet autoclave water quality requirements. This tank shall be sized to accommodate both the autoclave and any sinks within the trailer of the MLS. Primary Containment Equipment: • The Contractor shall supply the Class II Type A2 BSC based on laboratory design/space plan that shall take place, following contract execution. The BSC's shall have interior UV lights on timers for surface decontamination. • The Class II BSC's shall be custom engineered and manufactured to meet the size and height constraints required for proper installation in a mobile lab. • The Class II BSC shall be engineered and designed for rough handling due to constant mobile laboratory transport. • The Contractor shall ensure proper placement of the Class II BSC in the mobile lab with regards to doors, supply air registers and personnel movement. • A UPS shall be provided for each BSC. Additional UPS's shall be installed at circuits deemed critical during the preliminary design of the MLS. • Each Class II BSC shall be equipped with a UPS, providing at least 20 minutes of battery powered operation, in the event that the primary lab power is lost. Laboratory Equipment: • The Contractor shall supply an integrated pass-through double door autoclave with a minimum capacity of 160 liters. The autoclave must also seal through the wall using the appropriate bio-seal. • All laboratory equipment (refrigerators, freezers, incubators, Class II BSC, autoclave) must be secured for rough handling due to constant mobile laboratory transport. MLS Rooms and Spaces: Storage Room: • There shall be a section of the MLS dedicated to the secure storage of consumable materials. • This space shall have standard HVAC system climate control. • Shelves and cabinets shall be custom designed to meet the FDA's dry storage requirements with a foot print, not less than 80 square feet. • The Contractor shall install locking cabinets and D-rings to ensure materials do not shift during transport. • The storage room shall also be accessible from the interior and exterior of the MLS. Media & Quality Assurance Laboratory (Q/A): • This room requires HVAC supply air to be HEPA filtered. • The space must be able to be easily divided into 2 sections. • Two Class II Type A2 BSC's shall be installed (4 ft. in length). • One refrigerated incubator (under counter) and a laboratory refrigerator/freezer (stand-up, not less than 15.7 cu. Ft. combined space) shall be installed. • Hand washing sink with hands-free operation. • Vacuum connections shall be provided. • Vacuum pump shall be located in the mechanical space with lines plumbed to the connection points. Sample Preparation Suite: • There shall be one hand washing sink. • The Prep room shall be accessible from the interior and exterior of the MLS. Autoclave Room: • One double door pass-through autoclave shall be installed in the Autoclave room. Space for proper storage of waste shall be provided. • The autoclave room shall also be accessible from the exterior of the MLS. One double door pass-through autoclave shall be installed in the autoclave room. Space for proper storage of waste shall be provided. The autoclave room shall also be accessible from the exterior of the MLS. Incubation Room: • The incubation room shall be designed and constructed to house a minimum quantity of four (4) Thermo Scientific Forma 3960 Series Environmental Chambers. Provisions shall be made by the Contractor during the preliminary design process for the addition of two (2) or more Environmental Chambers. Thermo Scientific Forma 3960 Series Environmental Chamber • Capacity: 29 cu. ft. (821.2L) for high volumes and a broad range of products • Power Consumption: (150w)/129kcal/hr • Overall L x W x H: 33 x 38 x 80 in. (83.8 x 96.5 x 203.2cm) • Outputs: RS485, 0-1V, 0-5V, 4-20mA • Port[s]: Two 2.4 in. (6.1cm) I.D., one on each side • Net Weight: 500 lb. (226.8kg) • The incubation room must be designed and constructed to allow for the addition of up to two more large environmental chambers and may require engineering a removable wall. DNA Extraction Lab: • This lab requires HVAC supply air to be HEPA filtered. • This space shall be designed to house up to three MagMAX Express-96 Deep Well Magnetic Particle Processors (FDA provided). Combined Refrigerator & Freezer Space: • MLS manufacturer shall construct a "walk-in" refrigerator with an operating temperature of 4°C and a minimum of 25ft. The walk-in refrigerator shall have a stainless steel interior and include a floor drain to allow for routine wash down. The door shall be provided with safe-exit control. • A -20°C freezer shall be provided (not less than 15 cu. ft.) • A bench top -80°C freezer shall be provided (not less than 1.7 cu. ft.) • The MLS provider shall provide an alarming system installed on all refrigerators and freezers in order to alarm and contact (email or text) personnel in the event the device goes outside the established temperature range. • The refrigerator and freezer space shall also be accessible from the interior and exterior of the MLS. Cleanroom: • Supply air to the cleanroom shall be HEPA filtered. • Manufacturer shall install a UV light on a timer within the cleanroom for surface decontamination. • There shall be a Class II Type A2 BSC installed in the cleanroom space. Analytical Laboratory: • This lab shall have HEPA filtration on the supply air. • The analytical lab space shall allow for the placement of up to nine real-time Polymerase Chain Reaction (PCR) machines and corresponding supplies (PCR machines supplied by FDA). • This laboratory shall include UV lights installed on timers for surface decontamination purposes. • The analytical room shall also be accessible from the exterior of the MLS. Confirmation Laboratory: • This lab shall have HEPA filtration on both the supply and exhaust air. • There shall be two hand washing sinks in this lab. • One laboratory refrigerator/freezer shall be installed (not less than 15.7 cu. ft.) Office: • The space shall include a common office area for the placement of up to five personal computer workstations as well as a universal printer (computers and printer are FDA supplied). • A smaller isolated office with locking door shall be located as part of this space. • Office space shall include a refrigerator/freezer for food and drink items (not less than 15.7 cu. ft.). • Office space shall include a unisex restroom with a hand washing sink (24 square foot minimum restroom space). • The Office room shall also be accessible from the exterior of the MLS. Training: • Provide training to select FDA Mobile Lab cadre members on the operations of the mobile lab, needed preventive maintenance operations and recommended schedules. • An unlimited number of select FDA Mobile Lab cadre members shall be trained. • Training shall be provided at the final delivery site. Maintenance: • Comprehensive on Government site post-warranty preventive maintenance and repair services, by factory certified technicians, inclusive of all labor, parts, and travel. • Unlimited phone and email technical support during Government hours of operation. Place of Performance Office of Regulatory Affairs (ORA) 3900 NCTR Road Jefferson AR, 72079 Responses to this sources sought shall unequivocally demonstrate that respondent is regularly engaged in the manufacture and/or sale of same or substantially similar items. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [Provide this same information again if responding to provide a product manufactured by another firm.] • Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items to include date of sale, description (should also include drawings and photos), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent; • Descriptive literature, brochures, marketing material, etc. detailing the nature of the items the responding firm is regularly engaged in manufacturing and/or selling; • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; • If a large business, identify the subcontracting opportunities that would exist for small business concerns; and • Though this is not a request for quote, informational pricing is encouraged. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before January 9, 2013 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Yolanda Peer, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email yolanda.peer@fda.hhs.gov. Reference 1113156. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1113156/listing.html)
- Place of Performance
- Address: Office of Regulatory Affairs, 3900 NCTR Road, Building 26, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02953162-W 20121222/121220234834-e9204391b6d997cdabfa57b8e904e2ff (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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