SOURCES SOUGHT
65 -- Rental of Mobile Sterile Compounding Unit
- Notice Date
- 3/4/2022 10:23:56 AM
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- 256-NETWORK CONTRACT OFFICE 16 (36C256) RIDGELAND MS 39157 USA
- ZIP Code
- 39157
- Solicitation Number
- 36C25622Q0561
- Response Due
- 3/11/2022 5:00:00 AM
- Archive Date
- 03/14/2022
- Point of Contact
- William Shaver, Contract Specialist, Phone: 601-206-6953
- E-Mail Address
-
William.Shaver@va.gov
(William.Shaver@va.gov)
- Awardee
- null
- Description
- DEPARTMENT OF VETERANS AFFAIRS VETERANS INTEGRATED SERVICE NETWORK (VISN) 16 REQUEST FOR INFORMATION 36C25622Q0561 REQUESTED RESPONSES: The intent of this Request for Information is to establish sources in order to define the procurement strategy. Interested contractors are requested to respond in accordance with the following Please respond to this RFI if you are capable of providing the brand name products listed in the Statement of Work found in the background section below. In the response, please cite business size status. POTENTIAL SOURCES SHALL PROVIDE THE FOLLOWING INFORMATION IN THEIR RESPONSE: 1) Company name, address, phone number, primary contact(s), e-mail address, NAICS code(s), business size (i.e., small/large) and DUNS Number. 2) Provide a Statement of Capability that demonstrates the offeror's past performance in providing these types of supplies. Please include the following: (a) Proof of OEM or OEM distributor of brand name supplies. (b) examples of prior completed Government contracts, references, and other related information. Please include contract number of previous contract. CONTACT INFORMATION AND RESPONSE DUE DATE: Please email all responses to William.Shaver@va.gov. Please respond to this RFI no later than 07:00 Central Standard Time on Friday, March 11, 2022. DISCLAIMER: This RFI is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Department of Veterans Affairs to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. BACKGROUND: Statement of Work A. GENERAL GUIDANCE 1. 53 Mobile Pharmacy Cleanroom Rental: To establish a contract for the rental of a mobile Pharmacy Cleanroom with remote support services for Central Arkansas Veterans Healthcare System, Little Rock, AR (CAVHS). 2. Scope of Work: Provide a 53 mobile pharmacy cleanroom and complete set-up as described in the statement of work (SOW) to serve as a temporary pharmacy cleanroom during the construction of a new pharmacy at CAVHS. The work covered under this contract consists of furnishing all labor, materials, tools, equipment, supervision, and necessary transportation to provide a fully functional mobile pharmacy cleanroom, with listed equipment, at CAVHS. The 53 mobile pharmacy cleanroom must provide all necessary equipment to include, but not limited to: entry/office area, anterooms (designated as an ISO 7 environment), hazardous drug preparation area (designated as an ISO 7 environment), and a sterile IV preparation/buffer room (designated as an ISO 7 environment). CAVHS must have access to 24-hour remote support services that includes daily reports sent via email of room temperatures, humidity, and pressures. Hazardous Drug Preparation Room: ISO Class 7 negative pressure environment At least 2 3 Class II Type A2 Biological Safety Cabinets Storage space Seamless welded stainless steel counter tops Sterile IV Preparation/ Buffer Room: ISO Class 7 positive pressure environment At least 2 4 vertical laminar airflow hoods Storage space Seamless welded stainless steel counter tops Anteroom: ISO Class 7 positive pressure environment Pressure gauges near doors to display room pressure Storage space for PPE Sink for hand washing Eye wash station Bench for changing clothes 3. Background: Pharmacy Service is submitting a request for the continuation of use of the mobile pharmacy cleanroom with remote monitoring services at CAVHS. To ensure continued service and access to care; there is a need to rent a mobile pharmacy cleanroom with an anticipated finish of early June 2023. 4. Performance Period: The period of performance is 6 months, with an option to renew for a (2) 3-month options for a total of 12 months. The rental will begin upon delivery. 5. Type of Contract: A firm-fixed-price. B. GENERAL REQUIREMENTS This project will provide a rental mobile pharmacy cleanroom at CAVHS. The project consists of: Provide a rental mobile pharmacy cleanroom with remote support services. Contractor shall assist the CAVHS engineer with connecting electrical and network. CAVHS engineer will make the electrical and data/telephone connections to the trailer after it is placed. Provide service, corrective maintenance on all supplied equipment during the rental period The contractor shall provide roundtrip delivery, set up and tear dismounting of the unit. Contractor shall assist the CAVHS engineer with connecting electrical and network. CAVHS engineer will make the electrical and data/telephone connections to the trailer after it is placed. CAVHS will be responsible for any permits, inspections and modifications to meet code regulations. Any transportation permits such as oversized loads shall be the responsibility of the contractor. VA engineering will provide necessary assistance electrical connections and plumbing with heat trace and insulation on hoses connected to the trailer. CAVHS will direct where the mobile pharmacy cleanroom will be placed. Contractor shall be responsible for providing repairs of faulty equipment within 72 hours. Contractor shall be responsible for contacting the local certifier for repairs or issues with faulty equipment (at no additional cost to the CAVHS). C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES: Special Requirements Contractor shall ensure the cleanroom as well as the primary engineering controls have been factory certified prior to arrival. CAVHS will be responsible for certifying the trailer prior to use. All electrical and networking data will be provided for the CAVHS engineer to connect to. A site visit will be scheduled by the contracting officer. Contractor attendance at the site visit is optional. Engineering Requirements Mechanical: Heat, ventilation and air conditioning (HVAC) will be required to be installed in the cleanroom to maintain a comfortable working temperature and humidity level in the pharmacy as designated in USP 797 while operating in the normal climatic conditions of the destination. Electrical: Must have connections for utility power and/or auxiliary generator inputs are provided with 50 foot long connection cables. Must meet electrical requirements of 480 volt, 3Ø, 150 Amp, 4 wires at the box outside at the pad. A transformer and breaker enclosure will need to be added. Plumbing: Must have an on-board fresh water tank and an on-demand electric water pump to provide running water for a sink and eyewash. Must have a grey water holding tank. The pharmacy cleanroom will arrive completely plumbed, ready for use via holding tanks. Utilities: Data ports shall be provided to network instrument data outputs, computer workstation, and a printer (computer and printer provided by end user). Cables will be run in shielded chases to a patch panel in the anteroom. 8 port unmanaged switch, input at the exterior in the form of a standard RJ-45 jack. Touchless phone shall be provided in both positive and negative pressure rooms. Digital video cameras and a digital video recorder (DVR) for perimeter security. All work surfaces are seamless stainless steel with casework designed for gas and vapor phase decontamination, and coved for easy spill cleanup and sanitization. Edges are rounded and polished to avoid snagging Personal Protection Equipment (PPE). D. GOVERNMENT RESPONSIBILITIES: The CAVHS will be responsible for providing power and plumbing as described, a concrete pad and CAT6 communications path and wiring to the trailer. CAVHS will be responsible for providing the following: Onsite semi-annual certification Personal Protective Equipment (PPE) Computers, printers, and software Chairs Waste Bins Ramps Fire system Wireless internet E. CONTRACTOR EXPERIENCE REQUIREMENTS: QUALIFICATIONS/CERTIFICATIONS A. The contractor shall be qualified and have the required levels of professional and technical experience to perform the work required by this statement of work. F. EQUIPMENT: All equipment, tools, etc., shall be properly maintained while on the project and shall be adequate, in quality and capacity, for proper execution of the work. G. SCHEDULING AND HOURS OF WORK CAVHS requires the trailer to be delivered and operational within 60 days after receipt of order by the vendor. All work in areas involved shall be scheduled with the VA Engineering Service representative. Work shall be scheduled for proper execution to completion of this contract. Delivery of the trailer should be coordinated with the VA and occur at a time when traffic and congestion is lessened. This is period shall be a time other than 6:30 am 5:30 pm Monday Friday. The 11 holidays observed by the Federal Government, i.e., New Year s Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas or any other day specifically declared by the President of the United States to be a national holiday. H. SITE VISITS Job site shall be visited to verify all existing conditions and dimensions and the extent of work involved with the VA Engineering Service Representative. Visits to the site may be made by appointment only, during regular business hours, with the VA Contracting Officer Representative (COR) Taylor Hamilton. I. INSPECTIONS: All work shall be inspected during installation and at final completion by the VA technical representative. J. SAFETY REGULATIONS: All applicable safety regulations shall be observed during all work of this contract. The VA Safety Officer shall have full authority to see that the contractor obeys all safety rules and regulations relative to the fulfillment of this contract. CAVHS will be responsible for providing the necessary barricades/signage where required. K. INFORMATION SYSTEMS SECURITY OFFICER, INFORMATION PROTECTION: The C&A requirements do not apply and a Security Accreditation Package is not required. The contractor will not have access to VA Desktop computers and they will not have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. L. PRIVACY OFFICER: The contractor will not have access to protected Patient Health Information (PHI) and they will not have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified. M. RECORDS MANAGER: There will be federal records created, maintained, used, or disposed of with this contract; regardless of format or mode of transmission. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.. Item: Mobile Pharmacy Cleanroom Essential physical, functional, or performance characteristics of the mobile pharmacy cleanroom listed below: Functional Characteristics: The required mobile pharmacy cleanroom (MPC) is necessary to provide ongoing and uninterrupted provision of essential pharmacy services. It will ensure that pharmacy employees will be able to prepare pharmaceutical compounded sterile preparations (CSPs) that meet the standards of the United States Pharmacopoeia (USP) Chapter797 (USP ) Pharmaceutical Compounding-Sterile Preparations and Chapter (USP ) Hazardous Drugs-Handling in Healthcare Settings , and complies with the National Institute of Occupational Safety and Health (NIOSH) recommendations for pharmacy practices for both hazardous and nonhazardous medications. To remain in compliance with these standards, it is imperative that the characteristics of the system are as listed below and are compatible with our existing electrical, plumbing, and data connections at the mobile trailer pad at John L McClellan. Physical Characteristics: Exterior: must be a mobile trailer on wheels with connections that enable it to be moved by commercial tractor/trailer must have HVAC units or other external components on the front of the MPC to allow an adequate turning radius of the truck when attached to the MPC must have all required lighting and signage on the exterior of the MPC to meet DOT regulations must be resistant to high and low temperatures, high humidity, wind, and rain must shall be equipped with a levelling system to be employed when placed on uneven surfaces must not exceed 53 feet in length and 8.5 feet in width Interior: must have interior walls composed of a high-performance composite must provide a seamless interior suitable for frequent wash-downs with sanitizing agents as well as gas decontamination. must contain floors which are composed of seamless material coved up the walls for ease of cleaning. Rooms: Non-hazardous buffer room must maintain, under the International Organization for Standardization, (ISO) Class 7 positive pressure air quality relative to the non-hazardous anteroom outside to create an outward directional airflow from the buffer room to the anteroom. must have at least 50 ACPH must have minimum space of 15 X 8 X 7.25 high ceiling must have a HEPA filtered passthrough box for easy transport of drugs in and out of the buffer room area. must contain adequate space and utilities for at least two vertical laminar flow clean benches (clean bench must be provided) Vertical Laminar Flow Clean Bench must be 3 ft wide must be stainless steel or bacterial resistant must contain adequate space and utilities for at least one refrigerator (refrigerator must be provided) Refrigerator: must have 20 cu ft of storage space for daily storage of temperature sensitive medications must have a digital thermostat must have a temperature range of at least 36 46 degrees Fahrenheit must have forced cooled air must have access ports for installation of local temperature monitoring equipment must have an external surface that is stainless steel or bacterial-resistant must have an internal light must have door alarm must have a power failure alarm with a backup battery must have return air vents placed low to the floor of the unit and positioned behind particle generating areas must contain adequate space for stainless steel furniture for daily operations as well as medication/supply storage (furniture must be provided) Furniture (edges should be seamless and rounded to prevent snagging of clothing): 4 ft shelf 2 ft table/counter cart must have pressure gauge outside of the room for monitoring room air pressure differential Non-hazardous anteroom must maintain, under the International Organization for Standardization, (ISO) Class 8 positive pressure air quality relative to the Office/Entry room to create an outward directional airflow from the anteroom to the Office/Entry room. must have at least 60 ACPH must contain a sink for handwashing must have an area for PPE storage must have an area for supply storage must have an eye wash station must have an area for sitting must have an area for garbing must have pressure gauge outside of the room for monitoring room air pressure differential Hazardous buffer room must maintain, under the International Organization for Standardization, (ISO) Class 7 negative pressure air quality relative to the Hazardous anteroom to create an inward directional airflow from the anteroom to the buffer room. must have at least 40 ACPH must provide minimum space of at least 12.75 X 8 X 8.5 high ceiling must have a dedicated exhaust and stack pipe that is a distance of at least 25 feet from MPC intake air must be equipped with a secondary exhaust fan on a speed controller to remove biological safety cabinet (BSC) exhaust and negatively pressurize the duct must have a HEPA filtered passthrough box for easy transport of drugs in and out of the buffer room area. must contain adequate space for at least two Class II Type A2 biological safety cabinets (cabinets must be provided) Class II Type A2 biological safety cabinets must be at least 3 ft wide must be stainless steel must have an airflow alarm must contain adequate space for at least one refrigerator (refrigerator must be provided) Refrigerator: must have 20 cu ft of storage space for daily storage of temperature sensitive medications must have a digital thermostat must have a temperature range of at least 36 46 degrees Fahrenheit must have forced cooled air must have access ports for installation of local temperature monitoring equipment must have an external surface that is stainless steel or bacterial-resistant must have an internal light must have door alarm must have a power failure alarm with a backup battery must have pressure gauge outside of the room for monitoring room air pressure differential must have return air vents placed low to the floor of the unit and positioned behind particle generating areas must contain adequate space for stainless steel furniture for daily operations as well as medication/supply storage (furniture must be provided) Furniture (edges should be seamless and rounded to prevent snagging of clothing): Shelf (4ft wide x 12 in deep x 6ft high) minimum of 16 linear feet of stainless steel shelving 2 ft table/counter Cart (2 W x 2 D x 3 H) Two ergonomic anti-microbial task chairs compliant with ISO Class 7 standards must have pressure gauge outside of the room for monitoring room air pressure differential must have visual gauges and audible alarms to display differential pressures and alert operators in the event of a failure Hazardous anteroom must maintain, under the International Organization for Standardization, (ISO) Class 7 positive pressure air quality relative to the Office/Entry area and the Hazardous Buffer room to create an outward directional airflow from the anteroom to both the Office Entry area and the Hazardous Buffer room. Must have at least 60 ACPH must contain a sink for handwashing must have an area for PPE storage must have an area for supply storage must have an eye wash station must have an area for sitting must have an area for garbing must have pressure gauge outside of the room for monitoring room air pressure differential Office/Entry room must provide a minimum space of 9 X 8 X 8.5 high ceiling must have portable stairs with handrails and the stairs must be adjustable to provide stability on solid parking surface such as concrete/asphalt that is not level must have a removable exterior awning capable of covering the entrance must contain at least one stainless steel workstation, each large enough for a computer, printer, and office chair must contain four data ports for network connection of at least two computers and two printers must be able to access both hazardous and non-hazardous anterooms from office area. Lighting: must have adequate lighting as outlined in USP 797 and in accordance with the CFR, Lighting Design Manual. must be equipped with outside lighting capable of being powered by local power or a backup generator (generator should be provided). Security: must have a door with a minimum of 36 W X 78 H and equipped with a key deadbolt lock as well as a mechanical keypad locking door handle. must have a self-contained security system with alarm must have inside and outside digital video cameras and a digital video recorder (DVR) for internal and perimeter security. must have an 8 camera CCTV security camera system and an external security camera system with 5 external and 3 internal cameras must include fire pull stations as well as horns/strobes Instruments: must have pressure gauges, temperature gauges, and humidity gauges to determine compliance with USP 797 standards Mechanical: must contain a HVAC system to control both cleanroom temperature and humidity. must be able to meet drug and supply manufacturer standards for storage must meet USP 797 standards must be able to achieve 30 ACPH within each room except the office/entry room. Electrical: must be equipped with a diesel generator to power critical systems with a fuel tank capable of storing 50 gallons of fuel, and power inputs with a minimum length of 50-foot cables. Connections for utility power and/or auxiliary generator inputs must have at least 50-foot-long connection cables. must meet electrical requirements of facility using 120V/208V, 60Hz, 3ph, 300A, 4 wire + ground connection must be equipped with a diesel generator and an automatic transfer switch to backup all essential loads. Plumbing: must include an on-board fresh water tank with a minimum of 85 gallons of clean water and an on-demand electric water pump to provide running water for a sink and eyewash must be able to connect to local water utility tap must have ¾ supply and 1.5 waste water connections must contain a gray water tank designed to be gravity drained must be completely plumbed, ready for connection to water supply and drain lines Data Network: must contain Cat6 copper UTP cable must contain data ports for networked devices, computer workstations, and a printer must have network cables run in shielded chases Telephone: must have phone ports in the office/entry area must have an intercom system which allows two-way communication between the office/entry area, the non-hazardous buffer room, and the hazardous buffer room Complete generic identification: mobile pharmacy cleanroom, mobile compounding pharmacy Preferred manufacturer name: Germfree Applicable model/make/catalog number: MPCT-R12 DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/e3b0efa395844eadb70fb3290e9e7292/view)
- Place of Performance
- Address: Department of Veterans Affairs Central Arkansas Veterans Healthcare System 2200 Fort Roots Drive, Little Rock 72114, USA
- Zip Code: 72114
- Country: USA
- Zip Code: 72114
- Record
- SN06258194-F 20220306/220304230105 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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