Q301--Inspection & Certification of Fume Hoods, Ventilators, Biological Safety Cabinets, and Isolators - VA Loma Linda Healthcare System - Five Year Contract Opportunity

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-01. This solicitation is set-aside for 100% for Small Business concerns IAW FAR 19.502-2, Total Small Business Set-Asides. The associated North American Industrial Classification System (NAICS) code for this procurement is 541380, with a small business size standard of $19.0 Million. The FSC/PSC is Q301. VA Loma Linda Healthcare System (VALLHCS) located at 11201 Benton St, Loma Linda, CA 92357 is seeking a potential qualified contractor that can provide Inspection & Certification of Fume Hoods, Ventilators, Biological Safety Cabinets, and Isolators. All Interested entities shall provide quotations for the following: TITLE: VA Loma Linda Healthcare System (VALLHCS) Inspection & Certification of Fume Hoods, Ventilators, Biological Safety Cabinets, and Isolators. BACKGROUND INFORMATION: VALLHCS provides high quality care while ensuring the safety of its staff, patients, and visitors. A critical component of this commitment involves ensuring that all fume hoods, ventilators, biological safety cabinets, and isolators within the VA facilities are functioning optimally and meet applicable regulatory standards. Regular inspection and certification of this equipment are essential for supporting clinical, research, and pharmaceutical operations while protecting personnel and the environment from hazardous materials. OBJECTIVES: The objective of this contract is to engage a certified contractor with proven expertise to provide monthly, bi-annual inspections, certification, testing and maintenance services for all fume hoods, ventilators, biological safety cabinets, Viable Particle Surface and Air Sampling and Analysis for medium risk facilities and isolators within the VALLHS facilities. The contractor will ensure all equipment meets or exceeds current regulatory and safety standards, including but not limited to those set by the National fire Protection Association (NFPA), occupational Safety and Health Administration (OSHA), and U.S Pharmacopeia (USP) SCOPE: The Contractor shall provide all parts labor, transportation, equipment, supervision, and certified personnel to perform on-site bi-annual and monthly inspections and certifications of Government-Owned Fume Hoods, Ventilation Devices, Biological Safety Cabinets (BSC), Laminar Flow Devices, Isolators, Biosafety Hazard Hoods, Sterile Workbenches, Radiation Safety Hoods, Buffer, Ante spaces, and Pharmacy Clean Rooms (see section 6.1). The Contractors shall be responsible for removing or disposing of Hazmat. The contractor shall provide bi-annual or monthly inspections, certifications and testing on the equipment listed below: MANUFACTURER TYPE S/N ITEM NUMBER LOCATION LABONCO 3620904 020119684E 26754 2C05 Lab Equip CO H7-48 H7-48H 40092 2C05 Lab Equip CO H7-48G H7-48G UNK 2C07 LABONCO 36209-00 247536 40138 2C07 Fisher FB-PCR2 1591080398158 41427 2C22 Lab Equip CO H7-48D H7-48D 40096 2C24 Lab Equip CO H7-48E H7-48E 40094 2C22 Lab Equip CO H7-48C H7-48C 40095 2C25 Lab Equip CO H7-48B H7-48B 40097 2C26 LABONCO Premier 160729357B UNK 2C27 LABONCO Premier 160729358B UNK 2C28 LABONCO 3440000 070976549 39977 2C29 LABONCO Premier 160729356B UNK 2C30 Lab Equip co H7-48S H7-48S 40112 3C28 Lab Equip co H7-48R H7-48R 40111 3C27 LABONCO H7-48CC H7-48CC 40122 4C22B Forma Scientific 1284 18565-370 45031 4C22B LABONCO 36209-08 257688 16334 4C22B Lab Equip co H7-48AA H7-48AA 40124 4C25 Lab Equip co H7-48V H7-48V UNK 4C02 LABONCO 36209-00 214517 9615 4C02 Lab Equip co H7-48U H7-48U 40118 4C03 Lab Equip co H7-48Y H7-48Y UNK 4C04 LABONCO 3620904 010916879E 45029 4C04 Lab Equip co H7-48W H7-48W UNK 4C05 USA Scientific AC648LFUVC 42337 44237 4C05 Lab Equip co H7-48X H7-48X 40121 4C06 Fisher Scientific PCR - UNK 4C06 Mopec - ME400L09002 45782 1B25 Lab Equip co H7-48Z H7-48Z 6946 4C07 LABONCO 3440000 070976500 39976 4C07 BMC 6315-08 1DLA-26 45027 1B28 LABONCO 3440809 080891842B 45030 4C07 Lab Equip co H3-72 143-72 45022 1B49 LABONCO 36209-01 192918 8742 4C07 Labgard NV-629-600 12697011108 43090 1B28C BMC 6315-08 1LLB-38 45018 1B51A BMC 6315-08 1LLB-28 45019 1B51A BMC 6315-08 1LLC-2 45020 1B51H BMC 6315-08 1LLB-15 45017 1B50A BMC 6315-08 1LLB-9 45016 1B50 BMC 6315-08 1LLA-21 45015 1B50 LABGARD NV-629-600 126966111008 43091 1B30 LABGARD NV-629-600 126965111008 43092 1B21 LABGARD NV-629-600 126971111008 43090 1B22 LABGARD NV-629-600 126967111008 43093 1B22 Nuaire NV-612-SPEC 80565103002 45023 1B23 Nuaire NV-602-400 11674091301 40299 1B22 LABONCO 36209-04 990906254 28319 1B25 Germfree LFGI-6USP 65-15-LUG-16441 Pharmacy-67087 2C-125 Cancer Center Germfree LFGI-6USP 65-15-lUG-1644o Pharmacy-67088 2C-125 Cancer Center Baker Company EGB-6252 67642 Pharmacy-40255 1C-27 Main Baker Company EGB-6252 67643 Pharmacy-40168 1C-27 Main Germfree LFGI-6USP 6S-15-LGU-13405 Pharmacy-41505 4C-31 Main Germfree LFGI-4USP 4S-15-LGU-13340 Pharmacy-41506 4C-31 Main Hazardous- BBF-3SSRX 3S-15-BR-16215 Pharmacy-Trailer IV-TRAILER Hazardous- BBF-3SSRX 3S-15-BR-16216 Pharmacy-Trailer IV-TRAILER Non-Hazardous BVBI-3SSRX 3S-15-BVBI-16217 Pharmacy-Trailer IV-TRAILER Non-Hazardous BVBI-3SSRX 3S-15-BVBI-16218 Pharmacy-Trailer IV-TRAILER Contractor shall perform the following testing: Bi-annual Down flow velocity Inflow Velocity Airflow Smoke Pattern Test HEPA Filter leakage Static Pressure Reading (unit & Duct) Site Assessment Environmental conditions for temperature, humidity, and pressure Smoke test Pattern. Airborne non-viable particle counting Monthly Viable Particle Surface and Air Sampling and Analysis for medium risk facilities Contractor shall provide a Field Service Report (FSR) via email to the contracting officer Representative (COR within ten (10) days of completed service. Contractor shall provide the fallowing information: Type of equipment (i.e. Fume Hood) Manufacture Model Number Class (i.e. AII) Serial Number VA Equipment Entry (EE) number Building and Room the equipment is located in. Test date. Pass or Fail Date of next inspection The contractor shall revalidate the data if any equipment is added or removed. The contractor shall affix label to each unit that passes certification. The contractor shall affix labels on the day the inspection was passed or the certification date. The contractor shall provide label that includes: Company name Mailing address Telephone number. Certificate Name ( certificate of Environmental Compliance to CAL or OSHA and NFS standard NO.49 ) Equipment Manufacture Equipment Name Inspection Date Date of next inspection Signature of inspector Full printed name of inspector Status: Certified Unit ID Number from contract The contractor shall affix label to each unit that fails certification. The contractor shall affix labels on the day od the failed inspection or certification. The contractor shall provide label that includes: Company Name Mailing Address Telephone number. Equipment manufacture Equipment Name Inspection Date Signature of inspector Full printed name of inspector Status: Failed Unit ID number from contract Contractor shall submit a written statement of repairs needed (to be referred to as Failed Inspection Report), including an itemized listing of parts deemed necessary to certify the unit. This must be submitted to the COR prior to leaving the facility on the day of attempted certification. This information must be written in detail so that the COR may pass it to a Repair Contractor (if selected to be different from the Certification Contractor) thus enabling this other contractor to bring all materials and parts needed at the time of service to effect repairs rendering the unit certifiable. If a hood is deemed non-repairable, not meeting industry standards, and failing the test requirements, the Contractor shall provide the COR with the Failed Inspection Report outlining specific non-repairable/replaceable parts that prevents certification on the same day of the inspection. The Contractor shall notify the COR verbally and through a written report of any equipment not being repaired to the COR prior to leaving the Government premises. Emergency line item - Over and above repairs. Over and Above Repairs - For the emergency services, repairs and maintenance that are over and above the SOW, if quote pricing is within the COR s Government Purchase Card (GPC) threshold, the COR will authorize payment. For emergencies over the COR s GPC threshold, only the Contracting Officer (CO) is authorized to approve contract modifications. Additional services shall be approved by the Contracting Officer prior to the contractor initiating any work. The contractor shall provide an on schedule- quote to both the CO and COR for review and consideration. Additional funding will be provided by the facility as needed for payment. TRAINING The contractor personnel performing inspection and certification services shall be fully accredited and certified to conduct test, evaluations and certification of the equipment assigned. The contractor personnel shall have validated certification of Accreditation from National Sanitation Foundation (NSF) International: Biohazard Cabinet Field certifier Accreditation Program. The certificate of accreditation shall specify the initial and expiration dates and this certification shall be verifiable on the NSF website and shall be provided to the COR ten (10) days fallowing award. The contractor shall be required to update accredited contractor personnel certifications throughout the life of the contract as changes occur to staff. New employee credentials of accreditation for equipment on contract and training certificates must be submitted and approved by the COR prior to the employee commencing any work on this contract. INSPECTIONS The contractor shall perform inspections bi-annually. Inspections, certifications, and testing are to be completed within the first fifteen (15) working days of each scheduled service. Inspections shall be mutually agreed upon by the COR and contractor thirty (30) days prior to the inspection. The contractor is responsible for complying with the inspection schedules. PERIOD OF PERFORMANCE: 30 days from performance start date. Work may be scheduled during the day or night (Depending on load demand), Monday thru Friday and/or Saturday thru Sunday. Daytime hours: 6 am to 4 pm Evening hours: 4 pm to 4 am Contractor shall initiate work within 2 weeks of being contacted by the designated Contracting Officer s Point of Contact (POC) or designee. Work shall be scheduled through the POC or designee, who will coordinate with VALLHCS staff. Timelines are subject to change due to VALLHCS operational requirements. PLACE OF PERFORMANCE: Main Hospital VA Loma Linda 11201 Benton St. Loma Linda, CA 92357 LICENSING REQUIREMENTS: Offeror must possess a 30-hour Occupational Safety and Health Administration (OSHA) safety card. ANSI certification of accreditation ISO/IEC 17025:2017 calibration and testing SPECIFIC REQUIREMENTS: Contractor shall schedule start date with POC or designee five (5) business days in advance. The contractor shall provide bi-annual or monthly inspection, Certifications, and testing on the equipment listed. Contactor personnel shall have valid Loma Linda PIV badges before starting work. Contractor shall coordinate energy source LOCK OUT /TAG OUT procedures with VALLHCS HVAC Supervisor before starting work. When work is complete, Contractor shall notify the VALLHCS HVAC Supervisor that energy sources will be restored and require verification. Contractor s supervisor or lead technician are to check in with VALLHCS HVAC Supervisor, or in their absence, with Graphics Control prior to work each day. Contractor shall conform to the following standards, policies, regulations, governing agency, and any other local, state, or Federal guidelines that are not listed here. OSHA 29CFR Regulations, www.osha.gov NFPA 99, www.nfpa.org California Administration code. Title 8 NSF/ANSI 49 CDC/NIH Biosafety in Microbiological and Biomedical laboratories,4th ED, May 1999 NIH Guidelines for Research Involving Recombinant DNA Molecules, January 2001 American Society of Hospital Pharmacists Technical bulletin on Handling Cytotoxic Drug in Hospital Food and Drug Administration Joint Commission CAL/OSHA 5154 International Organization for standardization (ISO0 class5,7, and 8 Criteria) ISO 17025 and 14644 CAG-003 and CAG-009 IEST-RP-CC002 United States Pharmacopeias (USP) 797, (USP) 800 and 116 AUTHORIZED SERVICES: Only those services specified herein are authorized under this contract. Before permitting and/or performing any service of a non-contract nature, the Contractor shall advise the CO of the reason (s) for the additional work and/or service. The Contractor is cautioned that only the CO or his/her designee may authorize additional service that are within the scope of this contract and that reimbursement shall not be made unless prior authorization is obtained from the CO. All changes to the contract shall be issued through a contract modification in writing from the CO to the Contractor. DELEGATION OF AUTHORITY: No additional service shall be provided without the approval from the Contracting Officer (CO) or his/her designee of this contract. The Contractor shall not accept any instructions issued by any other person(s) other than the CO or his/her delegated representative acting within the limits of his/her authority. GOVERNMENT-FURNISHED EQUIPMENT (GFE) GOVERNMENT FURNISHED INFORMATION (GFI): No Government equipment will be used by the Vendor. RECOGNIZED HOLIDAYS: The following is a list of all Government recognized holidays: In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following National holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays : New Year s Day: January 1 Martin Luther King s Birthday: Third Monday in January President s Day: Third Monday in February Memorial Day: Last Monday in May Juneteenth Independence Day: June 19 Independence Day: July 4 Labor Day: First Monday in September Columbus Day: Second Monday in October Veterans Day: November 11 Thanksgiving Day: Fourth Thursday in November Christmas Day: December 25 If a holiday falls on Sunday, the following Monday shall be observed as the legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a legal holiday by U.S. Government agencies. Also included, would be any other day specifically declared by the President of the United States of America to be a National Holiday. CONTRACTOR EMPLOYEES AND BADGES: Contractor personnel shall present a neat appearance and be easily recognized as Contractor employees. Examples: wearing of distinctive clothing such as uniform, badges, patches, etc. All contractor personnel shall be required to wear VA always provided identification (I.D.) badges above the waist while on the VA grounds. Contractor shall be required to coordinate with the COR to obtain the VA provided I.D. badges for all staff. All VA provided I.D. badges shall be returned at the end of the contract or upon completion of service. Failure to wear ID badges may result in removal from any of the VA facilities and/or otherwise referred to Government property. SAFETY AND PPE EQUIPMENT: Personal Protective Equipment shall be provided for each Contractor employee by the Contractor. Possession of weapons are prohibited. SMOKING and VAPING POLICIES: Smoking and vaping are prohibited on Government property. PARKING: It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Security Service. The VA shall not invalidate or make reimbursement for parking violations of the Contractor's personnel under any circumstances. COMPLAINTS: Contractor shall promptly and courteously respond to complaints within three (3) working days to the COR. Including complaints brought to the contractor s attention by the CO. Contractor shall maintain a written record of all complaints, both written and oral showing the identity of the individual, the nature of the complaint, and contractor s response. Contractor shall permit the Government to inspect the written records of complaints upon reasonable notice from the CO. Required submittals with quotes SHALL include following: Proof of: Offeror must possess a 30-hour Occupational Safety and Health Administration (OSHA) safety card. ANSI certification of accreditation ISO/IEC 17025:2017 calibration and testing The Contract Period of Performance is 2-5-2025 1-31-2030, with an FOP of Destination. Place of Performance/Place of Delivery: VA Loma Linda Healthcare System 11201 Benton St Loma Linda, CA 92357 The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (Dec 2022). ADDENDUM to FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services applies to and is included with this acquisition. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (Sep 2023). The following subparagraphs of FAR 52.212-5 are applicable: (b)(4), (5), (9), (11), (12), (18), (26), (31), (33), (34), (35), (36), (37), (39), (40), (55), (63), (c)(1), (2), (7), (8). All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. This is accomplished through the Tungsten Network located at: http://www.fsc.va.gov/einvoice.asp. This is mandatory and the sole method for submitting invoices. All quoters shall submit the following: All information required by FAR 52.212-1(b) Submission of Offers. All quotes shall be sent to the Network Contracting Office (NCO): contact@example.gov. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The following are the decision factors: Price, and past performance, with price more important. Past performance will be based on CPARS and FAPIIS ratings. No rating in CPARS is equal to a neutral rating. The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Questions shall be received not later than 01-29-2025, 8:00 AM MST at contact@example.gov only. Subject line should include RESPONSE TO RFQ 36C26225Q0366. Final submission of your response shall be received not later than 02-03-2025, 8:00 AM MST at contact@example.gov only. Subject line should include RESPONSE TO RFQ 36C26225Q0366. Submissions shall include your quote as well as a capabilities statement with qualifications proving all certifications and education required for the work being conducted in the SOW. Submissions not meeting all requirements of the SOW will be considered ineligible for award. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All quotes regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. contact@example.gov