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The Department of Veterans Affairs, Veterans Health Administration (VHA), Network Contracting Office 19 (NCO 19) is conducting a market survey and is seeking potential sources for the lease of a Pharmacy Cleanroom Trailer. This Sources Sought Notice is issued for information and planning purposes only. This is not a solicitation or a request for proposal and shall not be construed as an obligation or commitment by the Government. An award will not be made on any offers submitted in response to this notice, and it shall not be implied the Government is committed to providing any solicitation or award following this notice. The Government will not pay for any information received in response to this request, nor will the Government compensate a respondent for any costs incurred in developing the information provided.

Responses shall be submitted to jonathan.saiz@va.gov by 5:00pm EST on Friday, July 7th, 2023.

This notice is intended strictly for market research. The purpose of this Sources Sought Notice is to determine interest and capability of potential qualified sources of supply and determine the socioeconomic size classification of the supplier and manufacturer of the end item.

Interested companies shall provide, at a minimum, the following information with their response;

Company Name and Address:
Point of Contact (POC)
Name:
Email Address:
Phone Number:
DUNS Number:
UEI Number:

The anticipated North American Industry Classification System (NAICS) code is 532120 Truck, Utility Trailer, and RV (Recreational Vehicle) Rental and Leasing. Mark if your firm is eligible for participation in one of the following small business programs. If so, please indicate the program:

[ ] yes [ ] no - Small Business (SB)
[ ] yes [ ] no - HUBZone
[ ] yes [ ] no - Small Business 8(a)
[ ] yes [ ] no - Small Disadvantaged Business (SDB)
[ ] yes [ ] no - Women-Owned (WO) Small Business
[ ] yes [ ] no - Service Disabled Veteran Owned Small Business (SDVOSB)
[ ] yes [ ] no - Veteran Owned Small Business (VOSB)
[ ] yes [ ] no - Large Business
[ ] yes [ ] no - Other (please specify)

Please answer the following questions:

Does your company own or lease the Pharmacy Cleanroom Trailers that would be offered during solicitation?

What make and model is the trailer that would be offered and who is the manufacture?

What percent of work would require a subcontractor to complete on a Pharmacy Cleanroom Trailer lease?

Would the companies receiving subcontracts be like situated companies? This means, if your company is certified SDVOSB, would another SDVOSB receive the subcontracts. Like wise for VOSB and Small Businesses.

Can your company meet the limitations of subcontracting?
FAR 52.219-14 Limitations on Subcontracting.
VAAR 852.219-75 VA Notice of Limitations on Subcontracting - Certificate of Compliance for Services.

Can your company meet the salient characteristics and required work below?
Note: Do not include Proprietary, classified, confidential, or sensitive information in responses.

In addition to providing the information requested above, responding companies are encouraged to include any relevant information (specifications, cut sheets, brochures, capability statement, past experience etc.) to confirm the company s ability to meet the requirements outlined in this request.

Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. 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.



Statement of Work
Purpose: The Mobile Pharmacy Cleanroom will allow Department of Veterans Affairs (VA) 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 December 1, 2019 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 or Industry Standard Policies and Procedures for the proper intended performance of all items herein. The Mobile Pharmacy Cleanroom (MPC) will be used by the Eastern Oklahoma VA Health Care System (EOVAHCS) in the event that sterile compounding services are temporarily suspended within a VA facility in order to avoid interruptions in patient care. The lease would last for a duration of 12-60 months.

At minimum, the MPC shall include:

Security/Safety/Temperature:
The main door shall be equipped with proper security, which includes a dead bolt locking door from outside to the office. The exits signs will be highly visible in case of evacuation. An area available where a standard sized fire extinguisher (determined for the area) can be stored. All rooms must be able to maintain a temperature of 95°F). The exterior of the MPC must be constructed of weatherproof material.

Entry/Office Area:
The office area should be large enough and so configured that an employee can bodily enter and perform assigned work. This room should contain one workstation large enough to utilize a computer, IV label printer, regular printer and one office chair. This room shall have an intercom capable of communicating between all compounding rooms and the office area. The office shall have telephone and data connection. The office area or compounding ante/buffer rooms must have a system viewable to monitor temperature, pressure, relative humidity, and refrigerator temps. This system must be able to communicate externally when there are no occupants inside of the MPC.

Hazardous Drug Ante Room and Buffer Room Preparation Area (ISO Class 7)
The anteroom shall also be maintained under the International Organization for Standardization (ISO) Class 7 positive pressure air quality (0.02 to 0.05 in w.c.) to create an inward directional airflow from the anteroom to the hazardous buffer room with 30 air changes per hour (ACPH). The anteroom must have storage for PPE, a line of demarcation that is continuously embedded into the floor (no tape), a hands-free sink that can provide warm water and an eye wash station must be on the clean side of the line of demarcation and must be located at least 1 meter away from any PEC. The door leading into the hazardous buffer room must be hands free.

The Hazardous Drug buffer room must be maintained under negative pressure relative to the anteroom (-0.01 to -0.03 in w.c.). The ceilings and floors must be seamless, smooth, impervious, free from cracks and crevices, non-shedding and cleanable with sanitizing agents. Light fixtures must be recessed and sealed to the fixture frame. The buffer room must receive supplied air through a HEPA filter at ceiling level and the air return should be located low on the wall or floor level.

Within the ISO Class 7 hazardous buffer room, at least two Class II Type A2 Biological Safety Cabinets (BSCs) that are ISO class 5 shall be provided for compounding activities (minimum 4 ft each). BSCs will contain audible and visual alarms to alarm in the absence of negative pressure. The Class II Type A2 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. 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. There must be at least 1 meter of space

between the BSCs. A medical grade refrigerator must be available in either the buffer room or a hazardous storage area with capability for remote continuous temperature monitoring and audible alarm for storage of hazardous drugs. If a refrigerator is placed in the hazardous negative pressure buffer room, an exhaust located adjacent to the refrigerator's compressor and behind the refrigerator is needed. The refrigerator shall be positioned a minimum of one meter from the BSCs. The hazardous buffer room shall be equipped with an interlocking passthrough connected directly from to the pharmacist work area.
Hazardous Storage Area (Preferred)
A hazardous storage area is preferred with negative pressure to the surrounding area with at least 12 ACPH is requested. The storage area should have ample room and shelving. A medical grade refrigerator to store hazardous medications would be in this storage area.
Ideally, an interlocking passthrough would be located from this storage area into the hazardous buffer room.

Non-Hazardous Ante Room and Buffer Room (ISO Class 7):
The non-hazardous ante room should follow the same requirements of the hazardous ante room with the exception of being ISO Class 8 or better. An ISO Class 7 non-hazardous ante room with 30 ACPH is preferred.

The non-hazardous buffer room will have positive pressure in relation to the anteroom and will provide ISO Class 7 air quality (0.02 to 0.05 in w.c.). The ceilings and floors must be seamless, smooth, impervious, free from cracks and crevices, non-shedding and cleanable with sanitizing agents. Light fixtures must be recessed and sealed to the fixture frame. The buffer room must receive supplied air through a HEPA filter at ceiling level and the air return should be located low on the wall or floor level. The non-hazardous buffer room shall be equipped with an interlocking passthrough connected directly from to the pharmacist work area.
The room shall be equipped with two horizontal Laminar Airflow Workstations (LAFW) with an ISO class 5 environment for preparation of sterile non-hazardous compounds (minimum 4 ft each).
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:
The MPC will be at that location determined by the customer. The contractor will make a onsite visit prior to delivery to work with EOVAHCS engineering for any pre-delivery issues (power, plumbing, water waste, remote monitoring etc) at no cost to the EOVAHCS. The MPC must be delivered and fully operational and certified by August 1st, 2023 to 1011 Honor Heights Drive, Muskogee, Oklahoma 74401. The MPC must be available to be leased for 12-60 months.

Warranty and Repair:
The contractor shall repair or replace any item that malfunctions during the rental period. Contractor shall be responsible for contacting certifying company for repairs or issues with faulty equipment at no cost to EOVAHCS.

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