H299--Cleanrooms and Associated Controlled Environments Testing and Certification Services in Support of the NMVAHCS CSP CRPCC

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) DUNS 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. The New Mexico VA Health Care System Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (NMVAHCS CSP CRPCC) is seeking a potential qualified contractor that can provide Cleanrooms and Associated Controlled Environments Testing and Certification Services. 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 (16.5 Million Dollars). 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, mail, or ground carrier to: Southern AZ VA HealthCare System, 3601 S. 6th Avenue, Tucson, AZ 85723 or by e-mail to derek.lavey@va.gov. All information submissions to be marked Attn: Derek Lavey, Contracting Specialist and should be received no later than 3:00 pm MST on April 6th, 2020. Performance Work Statement Cleanrooms and Associated Controlled Environments Testing and Certification Services 30 March 2020 New Mexico Veterans Affairs Health Care System (NMVAHCS) Introduction: This requirement is for testing and certification of cleanrooms, clean tent, clean bench, and biosafety cabinets on behalf of the NMVAHCS Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSP CRPCC) in Albuquerque, NM. Background: The CSP CRPCC requires annual testing services for its cleanrooms and equipment. The cleanrooms and equipment are located at the CSP CRPCC building. The required services include written certification, HEPA Filter leak testing and particle counts for the cleanrooms. These services must meet ISO 14644-1 standards. The required services for the clean benches (hoods) per NSF-49 requirements. The vendor must be NEBB certified and use NEBB standards for all testing. Cleanrooms and Equipment: ITEM LOCATION REQUIRED SERVICE MODEL # SERIAL # Rooms Rooms 173-180 Classification Air Cleanliness Certification Storage Room BPLS Laboratory Flow Measurement Storage Room BPLS Laboratory Flow Measurement Storage Room BPLS Laboratory Flow Measurement Clean Tent Quarantine OR Disposition Classification Air Cleanliness Certification Clean Bench Disposition HEPA Test, Particle count and certification None None BioSafety Cabinet (hood) (577) BPLS Laboratory HEPA Test, Particle count and certification 13856 153979-1737 BioSafety Cabinet (hood) BPLS Laboratory HEPA Test, Particle count and certification 36209-08 261446 BioSafety Cabinet (hood) BPLS Laboratory HEPA Test, Particle count and certification 36209-08 261447 BioSafety Cabinet (hood) Biorepository Laboratory HEPA Test, Particle count and certification 1351 300227268 BioSafety Cabinet (hood) Biorepository Laboratory HEPA Test, Particle count and certification 1351 300227269 BioSafety Cabinet (hood) QC Assay Room HEPA Test, Particle count and certification 3620004 050942520 Required Services: Contract service shall provide a Cleanroom performance test and written certification. Contract shall provide an annual report detailing all testing and related comments. Conformance Standards: Contract service shall ensure that the cleanrooms, clean tent, and associated controlled environments are compliant with ISO 14644-1 air cleanliness standards. Contract services shall ensure that the Biosafety cabinets (hoods) and clean bench are compliant with NSF/ANSI 49 Class II standards and certified. Contract service providers are required to be NEBB certified. Hours of Coverage: Normal hours of coverage are Monday through Friday from 7:00 am to 4:30 pm MST. All service will be performed during normal hours of coverage unless requested or approved by the COR or his/her designee. Testing and Certification will be performed as scheduled by the COR or their designee. Testing and Certification will be performed during normal hours of coverage. Work performed outside the normal hours of coverage must be approved by the COR or his/her designee. Funding for services that are outside the normal coverage hours or on holidays must have approved funding prior to any service being allowed. Federal Holidays observed by NMVAHCS are: New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The Contractor's FSEs shall wear visible identification issued by NMVAHCS CSP CRPCC Security at all times while on the premises of NMVAHCS CSP CRPCC. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Smoking and vaping are prohibited anywhere at NMVAHCS CSP CRPCC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. Information Security: In accordance with Appendix A, Handbook 6500.6 Checklist blocks 7, the C&A requirements do not apply to this requirement, and Security Accreditation Package is not required. The nature of this requirement is technical; however, there is no information to be protected. Other Pertinent Information or Special Considerations: Delivery of cleanroom testing and certification shall be coordinated through the CSP CRPCC located at: 2401 Centre Ave SE Albuquerque, NM 87106 Points of Contact: SME Michael Chavez (505) 265-1711 ext. 6377 or 505-967-6495 COR Denise Baechtel (505) 265-1711 ext. 6305 Period of Performance: The period of performance shall be for one base year PLUS up to four (4) option years. The Government may extend the term of the awarded base/option year by written notice to the Contractor within 30 days of annual expiration date, provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary (>60 day) notice does not commit the Government to an extension. FY20 Base Year 06/01/20 05/31/21 FY21 Option 1 06/01/21 05/31/22 FY22 Option 2 06/01/22 05/31/23 FY23 Option 3 06/01/23 05/31/24 FY24 Option 4 06/01/24 05/31/25