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This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this sources-sought must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) UEID number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below. Please list work that your company has performed on contract within the last 5 years.
Contractor shall provide semi-annual testing and certifications services Carl T. Hayden VAMC chemical fume hoods, biosafety cabinets, BSL 3 Suites, Pharmacy drug compounding hoods and cleanroom suite and hazardous drug surface sampling per USP 800.

Important information: The Government is not obligated to/nor will it pay for or reimburse any costs associated with responding to this sources-sought synopsis request. 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. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service-Disabled Veteran Owned Small Business set aside. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 541380 ($16.5M).
Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov and complete Online Representations and Certifications Application (ORCA). Additionally, all Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. All interested Offerors should submit information by e-mail to doreen.masterson@va.gov. All e-mails must have as the subject line 36C26223Q0090 Semi-annual Testing and the Certification of the PVAHCS Laboratory Fume Hoods, Laboratory Biosafety Cabinets . All information submissions must be received no later than 3:30 pm MST on November 15, 2022.

Statement of Work for the Testing and the Certification of the PVAHCS Laboratory Fume Hoods, Laboratory Biosafety Cabinets
The Phoenix VA Health Care System (PVAHCS) has a requirement for the semi-annual inspection and certification of Biological Safety Cabinets (BSC), Chemical Fume Hoods, and clean rooms to include particle counts per the most current USP 797and 800 requirements. PVAHCS also has a requirement for hazardous drug surface sampling per USP 800.

Contractor shall provide all personnel, equipment and transportation necessary to provide the services discussed below for the Phoenix VA Health Care System, located 650 E Indian School Road, Phoenix, AZ 85012.

Semi-annual testing and certifications services Carl T. Hayden VAMC chemical fume hoods, biosafety cabinets, BSL 3 Suites, Pharmacy drug compounding hoods and cleanroom suite.

The semi-annual testing and certification services for the Carl T. Hayden VAMC Pathology & Laboratory Services Management (P&LMS) biosafety cabinets and chemical fume hoods, the annual ventilation pressure assessment of the BSL-3 Suite located in the Laboratory in accordance with ASHRE 110-2016 and one Baker biological safety cabinet USP 800 located in the Room 2340 Research Pharmacy. Coordination of work will be necessary with the POC in P&LMS and the POC in Research. The scope of testing must be completed within 3 days. Upon completing the testing of each hood, a final test report will be generated and a certification label will be affixed to each hood that successfully meets its respective acceptance criteria.

Research Service of three biosafety cabinets. Coordination of work will be necessary with the POC in Research Service. The scope of testing must be completed within 3 days. Upon completing the testing of each hood, a final test report will be generated, and a certification label will be affixed to each hood that successfully meets its respective acceptance criteria.
The semi-annual testing and certification services at the University of Arizona campus for the PVAHCS Research Service of three biosafety cabinets. Coordination of work will be necessary with the POC in Research Service. The scope of testing must be completed within 3 days. Upon completing the testing of each hood, a final test report will be
generated and a certification label will be affixed to each hood that successfully meets its respective acceptance criteria.
The semi-annual testing and certification services for the Carl T. Hayden VA Medical Center In-Patient Pharmacy Cleanroom Suite and associated USP 800 compounding hoods ensure that the USP 800 semiannual testing and certification is conducted on time as required per VA directives and USP 800.
The Contractor shall provide airflow visualization profiles with a glycol solution of the Pharmacy doorways (3) and hoods (4). The Contractor will test the Pharmacy doors to confirm the flow of air and pressurization from room to room are flowing in the correct direction.

The Contractor shall perform airflow profiles of the Pharmacy hoods over the critical work area to ensure there is no turbulent airflow patterns or reflux that may compromise the work area. The testing of the hoods shall be performed under static and simulated dynamic conditions.
The Contractor will provide semi-annual surface sampling of the following hazardous drugs used int the Pharmacy Cleanroom Suite and associated hoods within the pharmacy. The Contractor will perform a total of 6 sampling locations inside and outside of the Pharmacy Cleanroom Suite, specifically the operations that include compounding and administering hazardous drugs. As Gemcitabine must be sampled separately a total of 12 samplings is required semi-annually for testing and certification.
Fluorouracil
Cyclophosphamide Docetaxel
Methotrexate Gemcitabine (must be
Paclitaxel sampled separately)
Coordination of work will be necessary with the POC in the In-Patient Pharmacy. The scope of testing must be completed within 3 days. Upon completing the testing of each hood, a final test report will be generated, and a certification label will be affixed to each hood that successfully meets its respective acceptance criteria.

The Contractor shall test the one (1) Dental Clinic Laboratory Hood in accordance with the appropriate test standard or guideline and affix a certification sticker to the hood if it meets acceptance criteria. A final report will be provided representing the results of the testing.

The Contractor shall perform testing on one (1) Prosthetics exhaust systems in accordance with the Industrial Ventilation Guidelines. The Contractor shall provide air velocity readings for each device where applicable, calculate the total exhaust flow, as well as perform smoke testing to witness the capture velocity characteristics at the source or work area of each system.

Upon completing the testing, Contractor shall generate an individual report for each system tested. Included in the report will be any air velocities measured, the calculated total exhaust flow as well as a description of the capture velocity characteristics from the smoke testing.

Area
Item Description
Unit Cost
Qty
Item Cost
Annual Cost
In-Patient
Pharmacy
Cleanroom
Testing of Chemo Safety Hood (BSC)

2
Testing of Laminar Flow Hood

2
Testing of Pharmacy Isolator

1
Testing of Pharmacy Cleanroom Suite

1
Viable Air Testing (Bacteria)

8
Viable Air Testing (Fungi)

8
Viable Surface Testing (Bacteria) Viable

8
Surface Testing (Fungi)

8
Pharmacy Airflow Visualization
Profiles
4 Pharmacy Hoods (Static/
Dynamic)
3 Doorways
11 Videos

2
HD Sampling HD Surface Sampling
Fluorouracil
Cyclophosphamide
Methotrexate
Paclitaxel
Docetaxel
$375
6
$2250
$4500
HD Sampling HD Surface Sampling - Gemcitabine
$195
6
1170
$2340
Pathology
&
Laboratory Services
Testing of Class II Biological Safety Cabinet

4
Testing of Biological Safety Cabinet

2
Testing of Chemical Fume Hood

3
BSL-3 Suite Ventilation Assessment

1
Research
Testing of Biological Safety Cabinet at Carl T. Hayden VAMC Campus

3
Testing of Biological Safety Cabinet at University of Arizona Campus

3
Dental
Laboratory Safety Hood

1
Prosthetics
Testing of Chemical Fume Hood

1

Repairs and Service
Service for potential repairs for Carl T. Hayden VAMC chemical fume hoods, biological safety cabinets and USP 800 Pharmacy drug compounding hoods.

Service to decommission and decontaminate Carl T. Hayden VAMC chemical fume hoods, biological safety cabinets and USP 800 Pharmacy drug compounding hoods, which are no longer functional.

Service to move decommissioned and decontaminated Carl T. Hayden VAMC chemical fume hoods, biological safety cabinets and USP 800 Pharmacy drug compounding hoods to the Logistics Acquisition Material Management warehouse for excessing by the PVAHCS.

Service to install replacement Carl T. Hayden VAMC chemical fume hoods, biological safety cabinets, and USP 800 Pharmacy drug compounding hoods

Note: Service may or may not be required.

Specifications:
The Contractor is required to have the following current accreditations:
NEBB (National Environment Balancing Bureau) Cleanroom Performance Testing

CETA Registered Cleanroom Professional for Sterile Compounding Facilities\

NSF Standard 49 (National Sanitation Foundation) Class II Biological Safety Cabinets

American Board of Industrial Hygiene CIH (Certified Industrial Hygienist)

Copy of current accreditations must be submitted with your proposal.

The work is to be performed in accordance of the following standards:

American Society for Heating, Refrigeration and Air-conditioning Engineers
(ASHRAE) 110-2016 Standard 110-2016 -- Method of Testing Performance of
Laboratory Fume Hoods to ensure that Face velocities of 0.4 m/sec to 0.6 m/sec (80 ft/min to 120 ft/min) generally provide containment if the hood location requirements and laboratory ventilation criteria of this standard are met.

National Sanitation Foundation (NSF) Standard 49 for the testing and certification of class II biological safety cabinets.

The U.S. Pharmacopeia s (USP 800) General Chapter, Pharmaceutical Compounding Sterile-Preparations establishes the minimum standards required
for a facility to perform high quality compounded sterile preparations (CSPs) and hazardous drug sampling.

Controlled Environment Testing Association (CETA), which provides work practices and guidelines for industry professionals working with equipment such as cleanrooms, laminar flow devices, fume hoods, biological safety cabinets, isolation rooms and other controlled environments.

5. The C&A requirements do not apply. A Security Accreditation Package is not required. Contract personnel will not have access to VA information technology systems or sensitive information. Contract personnel will be escorted by PVAHCS staff when on premises.

VHA Supplemental Contract Requirements for Combatting COVID-19

Contractor employees who work in or travel to VHA locations must comply with the following:

Documentation requirements:
If fully vaccinated, contractors shall show proof of vaccination.
NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.
If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.Â

Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.Â

Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

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