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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 15, 2017 FBO #5713
DOCUMENT

65 -- Mobile IV Room Unit, National CMOP - Attachment

Notice Date

7/13/2017
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;National CMOP;3450 S. 4th St. Trafficway;Leavenworth KS 66048-5581
 

ZIP Code

66048-5581
 

Solicitation Number

VA77017Q0406
 

Response Due

7/31/2017
 

Archive Date

9/29/2017
 

Point of Contact

Jeffrey Crysler
 

E-Mail Address

Contract Specialist
(jeffrey.crysler@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Page 4 of 4 Statement of Work Semi-Trailer Mobile Pharmacy Cleanroom Linear Length: 53 feet Purpose: The Semi-Trailer Mobile Pharmacy Cleanroom 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 that are enforceable on July 1, 2018, and complies with the National Institute of Occupational Safety and Health (NIOSH) recommendations for pharmacy practices for both hazardous and non-hazardous medications. The Semi-Trailer Mobile Pharmacy Cleanroom (MPC) will be used by the Department of Veterans Affairs (VA) in the event that sterile compounding services are temporarily suspended within a VA facility in order to avoid interruptions in patient care. At a minimum, the MPC shall include: Semi-Trailer: The semi-trailer must be able to accommodate a standard truck with extended sleeper cab, such as Kenworth model T800. Placement of air conditioning units on the front of the unit shall allow an adequate turning radius of the truck when attached. Entry/Office Area The unit shall have 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 shall be equipped with proper security, which includes, locking doors from outside of vehicle to office, locking doors between the office area and compounding areas, and an external security camera system to control access to the pharmacy areas. Hazardous Drug Buffer Room Preparation Area (ISO Class 7) The Hazardous Drug preparation area 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 Biological Safety Cabinets (BSCs) with a laminar airflow ISO class 5 shall be provided for compounding activities. The Class II Type A2 Biological Safety Cabinets must be externally vented. The dedicated exhaust and stack pipe must be a distance of at least 25 feet from other intake areas. The unit must be equipped with an adjustable fan at the top of the pipe with slightly more power than the exhaust of the unit to pull the hazardous drug (HD) exhaust to the exterior of the roof of the unit. 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. The BSCs must be positioned a minimum of eight inches from the wall of the unit s HD buffer room wall to all for cleaning and equipped with an audible alarm to alert of possible failures in the air handling system or if service is disrupted. The pressure monitor for the room must have a numerical display. A medical grade refrigerator and freezer with capability for remote temperature monitoring must also be included for storage of hazardous drugs that is positioned a minimum of one meter from the BSCs. Non-Hazardous Drug/Buffer Room (ISO Class 7): The Non-Hazardous Drug/Buffer room will have positive pressure in relation to the anteroom and will provide ISO Class 7 air quality. The room shall be equipped with least two horizontal Laminar Airflow Workstations (LAFW) with an ISO class 5 environment for preparation of sterile non-hazardous compounds. The room must have return air vents placed low to the floor of the unit and positioned behind particle generating areas with one return located near the door. The pressure monitor for the room must have a numerical display. The Sterile IV Preparation/Buffer room must contain ample storage space including a medical grade refrigerator and freezer with capability for remote temperature monitoring. Non-Hazardous Drug Buffer Anteroom The room will serve as a changing area for personnel to don their Personal Protective Equipment (PPE) with a line of demarcation to indicate the separation of where personnel is required to put or remove PPE as required. The room shall contain ample storage space for PPE and a sink for handwashing. The anteroom must have return air vents placed low to the floor of the unit and positioned behind particle generating areas with one air vent located near the door. There shall be ample space for staff to change clothing within the room and shall be maintained at positive pressure relative to the outside. The anteroom shall be maintained under an ISO Class 7 air quality. Mechanical, Electrical, and Plumbing Systems Mechanical: A heating, ventilation, and air conditioning (HVAC) system will be installed in the trailer 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 for a minimum run time of 48 hours and shore power inputs with a minimum length of 50 foot cables. Plumbing: Unit shall be equipped with an on-board fresh water tank and 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. Data Network The unit shall provide data ports for 2 computer work stations and 2 printers. There shall also be at least one telephone port available in each anteroom. The vehicle must be able to hook up to a portable VA Very Small Aperture Terminal (VSAT) system, per VA VSAT requirements. 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. Submittal Information The VA is looking to receive input from vendors capable of providing a Semi-Trailer Mobile Pharmacy Cleanroom that meets or exceeds the above specification. Interested parties may submit a capability statement, no more than five (5) pages, for your company. Please include company name, company address, and DUNS Number. Structure of Responses: Responses are requested no later than 5:00PM CST on July 31st, 2017, via email to jeffrey.crysler@va.gov. The Primary Point of Contact (POC) for this request is as follows: Jeffrey Crysler, Contract Specialist Network Contracting Office 15, Phone (913) 684-0150 Each Vendor must answer the following Questions: (1) Is your company currently providing similar services to another government agency or other non-government customer? If so, please identify the agency or non-government customer. If you are unwilling to share your customers' identity, please address whether your company offers the same or similar services commercially (outside of the federal government). (2) Identify your company's Small Business size status based upon the applicable NAICS code of 334510. The Small Business Size Standard for this NAICS code is 500 employees. For more information refer to http://www.sba.gov/. Service-Disabled Veteran-Owned Small Business (SDVOSB) Veteran-Owned Small Business (VOSB) 8(a) Small Disadvantaged Business (SDB) Woman-owned Small Business Historically Underutilized Business Zone (HubZone) Small Business Concern Large Business Concern (3) The Government has selected the applicable NAICS code for this effort based upon the type of tyoe of product requested. If in responding to this request and you believe another NAICS code should be applicable, please identify the NAICS code you consider appropriate for this effort along with detailed supporting rationale. (4) Provide any other pertinent information as deemed necessary to demonstrate your and any proposed team member's capabilities and prior experience as it relates to the requirements set forth above. (5) Is your firm currently registered in VA's Vendor Information Pages (VIP) database? Yes ____ No ____ (6) List any General Services Administration (GSA) Schedules or Government-Wide Acquisition Contracts that you are currently performing under.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/45d30a9eeac06a4d5d9abfcc8b3a8e94)
 

Document(s)

Attachment
 

File Name: VA770-17-Q-0406 VA770-17-Q-0406.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3654602&FileName=VA770-17-Q-0406-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3654602&FileName=VA770-17-Q-0406-000.docx

 

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

Record

SN04579341-W 20170715/170714000240-45d30a9eeac06a4d5d9abfcc8b3a8e94 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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