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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 12, 2018 FBO #6075
DOCUMENT

23 -- MOBILE PHARMACY TRAILER - Attachment

Notice Date

7/10/2018
 

Notice Type

Attachment
 

NAICS

336212 — Truck Trailer Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 6;100 Emancipation Drive;Hampton VA 23667
 

ZIP Code

23667
 

Solicitation Number

36C24618Q9386
 

Response Due

7/13/2018
 

Archive Date

9/11/2018
 

Point of Contact

See Attachment
 

E-Mail Address

cole.culley@va.gov
(cole.culley@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Page 6 of 6 SOURCES SOUGHT: The Department of Veterans Affairs, VISN 6 Network Contracting Office (NCO) is conducting Market Research through this sources sought to help determine the availability of qualified Small Businesses (SB) registered under NAICS code 336212 capable of supplying a Mobile Pharmacy Cleanroom Trailer for the Durham VAMC. All specifications are attached below. If the contractor can provide the above items, the contractor shall provide a letter from the manufacturer stating they are an authorized distributor/licenser of their products. Failure to submit an authorized distributor letter shall result in the product(s) potentially offered to be considered grey market and shall not be considered technically acceptable. The capability statements received from this market research are for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not assume any costs incurred by the contractor in the preparation of responses. All responses shall be submitted in writing no later than July 13, 12:00 AM, EST to the attention of: Cole J. Culley, VA Medical Center, 27 Averill Avenue, Hampton, VA 23667. E-mail address: cole.culley@va.gov Performance location: VAMC Durham 508 Fulton Street Durham, NC 27705 Statement of Work Mobile Pharmacy Cleanroom Trailer Purpose: The purchase of a Mobile Pharmacy Cleanroom (MPC) trailer to ensure uninterrupted provision of essential medical and hospital services requiring compounded sterile products. The Mobile Pharmacy Cleanroom trailer will allow Department of Veterans Affairs Pharmacy employees 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. Additionally, this mobile pharmacy shall meet the guidelines within CETA CAG-003-2006 Certification guide for Sterile Compounding and any other applicable Federal, State, Local, Industry standards Policies, Procedures, Codes, Permit for the proper intended performance of all items herein. Mobility Requirements: The MPC must be a mobile trailer on wheels with connections that enable it to be moved by commercial tractor/trailer. The exterior of the MPC shall contain all required lighting and signage to meet DOT regulations and be resistant to high and low temperatures, high humidity, wind, and rain. Additionally, the MPC shall be equipped with a levelling system to be employed when placed on uneven surfaces. The trailer shall not exceed 55 feet in length. Entry Room - Pharmacist Work Area The pharmacist work area shall provide a minimum space of 8 X 8 X 7 high ceiling and shall have a ADA compliant ramp or portable stairs with handrails and the stairs must be adjustable to provide stability on solid parking surface such as asphalt that is not level to enter into an entry/office area. The main door will have a removable exterior awning capable of covering the entrance and stairs or ramp and exterior lighting at the entrance door. The room shall contain one work station large enough to utilize a computer and one office chair. This room shall contain a stainless-steel work bench/desk. This room shall have an intercom capable of communicating between all rooms. Hazardous Drug Buffer Room Preparation Area (ISO Class 7) The Hazardous Drug preparation area will provide a minimum space of 12 X 7 X 7 high ceiling and must be maintained under negative pressure relative to the anteroom. The anteroom shall also be maintained under the International Organization for Standardization (ISO) Class 7 positive pressure air quality relative to the outside to create an inward directional airflow from the anteroom to the compounding area. Within the ISO Class 7 Hazardous Drug Preparation area, at least two Class II Type A2 or A3 Biological Safety Cabinets (BSCs) with a laminar airflow ISO class 5 shall be provided for compounding activities. BSCs will contain alarms which will sound in the absence of negative pressure. The Class II Type A2 or A3 Biological Safety Cabinets must be externally exhausted in accordance with applicable building codes, USP 800, VA TIL Mechanical Specification, and NSF-ANSI regulations as appropriate. Ample storage space shall also be included so that hazardous drugs can be stored in the negative pressure area in accordance with USP 800 Hazardous Drugs- Handling in Healthcare Settings A medical grade refrigerator with capability for remote continuous temperature monitoring and audible alarm must also be included for storage of hazardous drugs. If a refrigerator is placed in a negative pressure buffer room, an exhaust located adjacent to the refrigerator's compressor and behind the refrigerator is preferred. The refrigerator shall be positioned a minimum of one meter from the BSCs. The hazardous drug compounding room shall be equipped with an interlocking passthrough connected directly from the compounding area to the pharmacist work area. Non-Hazardous Drug/Buffer Room (ISO Class 7): The Non-Hazardous Drug/Buffer room will provide a minimum space of 12 X 8 X 7 high ceiling and have positive pressure in relation to the anteroom and will provide ISO Class 7 air quality. The room shall be equipped with at least two horizontal Laminar Airflow Workstations (LAFW) with an ISO class 5 environment for preparation of sterile non-hazardous compounds. The Sterile IV Preparation/Buffer room must contain ample storage space including a medical grade refrigerator and room for metal shelving to store non-refrigerated products. The non-hazardous drug compounding room shall be equipped with an interlocking passthrough connected directly from the compounding area to the pharmacist work area. Additionally, this room shall will have monitors with numerical displays and continuous recording of differential pressure, humidity, temperature and an audible and visual alarm when out of range. This room shall have an intercom capable of communicating between all rooms. Anteroom(s) The MPC may have one anteroom capable of accessing both buffer rooms or may have an anteroom for each buffer room. Anteroom(s) will provide a total minimum space of 4 X 7 X 7 high ceiling (if two separate anterooms, area can be half the length in each) and will serve as a changing area for personnel to do in their Personal Protective Equipment (PPE) with a line of demarcation to indicate the separation of where personnel are required to put on or remove PPE as required. The room shall contain ample storage and changing space for PPE. The ante-room shall contain a hands-free activated sink(s) for performing hand washing on the clean side of the ante-room. An eyewash station and/or other emergency or safety precautions that meet applicable laws and regulations must be readily available. The room shall be maintained at positive pressure relative to the outside. The anteroom shall be maintained under an ISO Class 7 air quality. Ante room(s) will have monitors with continuous recording of differential pressure monitoring. Mechanical, Electrical, and Plumbing Systems Mechanical: A heating, ventilation, and air conditioning (HVAC) system will be installed in the MPC in order to maintain comfortable working temperature and humidity level within the unit. Electrical. The unit shall 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. The MPC should have the capability to connect to facility power utilizing a 200-amp, 480-volt 3 phase outlet. Internal electrical outlets will be provided in each room to support equipment specified in the statement of need. Plumbing: Unit shall be equipped with an on-board fresh water tank with a minimum of 70 gallons of clean water storage and a separate container for a minimum of 80 gallons of waste water with electrical water pump to provide running water for the sink. The unit shall also have connections in place so that a water utility tap can be used if needed for continuous operation. Lighting: Unit shall will be provided with interior lighting in accordance with the CFR, Lighting Design Manual, https://www.cfm.va.gov/til/dManual/dmLighting.pdf. Data Network Data lines will be provided in the following areas with the minimum number per area as follows; 6 in the office area, 3 in the hazardous compounding room, 3 in the non-hazardous compounding room. Data lines shall each be at a minimum Cat6 copper UTP cable. All lines shall be run from a central location patch panel out to a terminal end RJ45 jack. One additional data line shall be provided with a jack accessible from outside the trailer (uplink port). A single NEMA 5-15 electrical receptacle is required at the central patch panel location. The vehicle must be able to hook up to a portable VA Very Small Aperture Terminal (VSAT) system, per VA VSAT requirements. Security The main door shall be a equipped with a key and deadbolt lock. Locking system must provide single motion egress from the interior. The MPC will have a motion intrusion detection system meeting specification in VA Handbook 0730/4 and an external security camera system to control access to the pharmacy areas. Exterior doors for the generator or HVAC system must be able to be secured by deadbolt or key lock. Factory Certification At the time of delivery, the unit, as well as the BSCs and Horizontal (LAFW) will be certified by an outside vendor, other than the manufacturer of the unit, as fully compliant with USP 797 and USP 800. Delivery and Training will be provided at that location determined by the customer. Warranty The contractor shall repair or replace any item that malfunctions during the warranty period. Each quoting vendor will include drawing of proposal at a detailed level. Each vendor will submit brochure of like product(s) as this request. Salient Characteristics Pharmacy Compounding Trailer shall meet or exceed the following specifications and salient characteristics: USP and USP Certified Compliant with CETA CAG-003-2006 Certification guide for Sterile Compounding Facilities 1 ISO Class 7 Negative Pressure Buffer Room (Hazardous Drug) 40 ACH HEPA filtered supply air Exhaust 736 cfm 2 - 3 Class II Biological Safety Cabinets vented outside Pharmacy Grade Refrigerator Access to office area with airlocks 1 ISO Class 7 Positive Pressure Buffer Room (Non-Hazardous Drug) 50 ACH HEPA filtered supply air Exhaust 736 cfm 2 3 Laminar Airflow workstations Pharmacy Grade Refrigerator ISO Class 7 Anterooms for each Buffer Room Maintained at positive pressure with pressure gauges and displays Suitable in size for gowning Equipped with hand washing sinks Lockers for storing Personal Protective Equipment Eye and hand washing stations Alarms to indicate unsafe conditions Office area with access to both buffer rooms Space for 1 desk, chair, and computer Intercom capable of communicating between all rooms Heat, ventilation, and air conditioning (HVAC) sufficient for fully exhausted buffer rooms, in addition to maintaining comfortable working conditions Capability to connect to facility power utilizing a 45 kVA @ 208 volt, 125 amps, 3 phase outlets Auxiliary generator to power critical systems w/fuel supply 8 port unmanaged switch input at exterior in the form of an RJ-45 jack DVR capable CCTV System Plumbing Fully Plumbed 70 Gallon on board fresh water tank Capability to connect to fresh water utility 80 Gallon gray water tank Sinks in each Anteroom Data Phone Network Keyless entry main door 8 port unmanaged switch Cables in shielded chases Patch panel in the ante room Telephone port will be provided in the Entry room Input at the exterior in the form of a standard RJ-45 jack CCTV system
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/HaVAMC/VAMCCO80220/36C24618Q9386/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24618Q9386 36C24618Q9386.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4468447&FileName=36C24618Q9386-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4468447&FileName=36C24618Q9386-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04985892-W 20180712/180710231438-b00d5cef90823e764d7fad6a98108a47 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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