Inactive

Effective Date: 03/15/2023 Revision: 01 Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisiti... Effective Date: 03/15/2023 Revision: 01 Description 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 2024-05. This solicitation is set-aside for: Full and Open Competition The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a small business size standard of 1,000. The FSC/PSC is 6640. The RPOE, NCO 1, 950 Campbell Avenue, West Haven, CT 06516 is seeking to purchase a Benchtop Matrix-Assisted Laser Desorption/Ionization (MALDI) Time-of-flight (TOF) Mass Spectrometer. All interested companies shall provide quotations for the following: Performance Work Statement Benchtop Matrix-Assisted Laser Desorption/Ionization (MALDI) Time-of-flight (TOF) Mass Spectrometer West Haven VAMC Introduction West Haven VA Medical Center is seeking to replace their current end-of-life Benchtop Matrix-Assisted Laser Desorption/Ionization (MALDI) Time-of-flight (TOF) Mass Spectrometer which is currently hosting an unsupported operating system (OS). The new mass spectrometer, a crucial tool for our daily operations, must be pre-validated by the VHA to interface successfully with the laboratory information system (LIS) product for the Department of Veteran Affairs (Data Innovations). The mass spectrometer is used to sequence proteins, map biomolecules, identify microorganisms, and analyze several thousand biochemical assays daily. The tuberculosis lab, a vital part of our healthcare system, utilizes this instrument daily to complete lab analyses and maintain patient/staff throughput. The new Benchtop MALDI-TOF mass spectrometer must have the following features. Identification throughput (excl. sample preparation) 600 samples/hour1 (400 samples/hour). Prioritization of urgent sample analysis in < 3 min. Frequently maintained and extensive microorganism library. Advanced workflow & application solutions for Mycobacteria Testing, Fast Shuttle. Integrated ion optics cleaning without service intervention. Automated self-tuning without user interference nor sample preparation/costs. True benchtop system, no special reinforced desk required (166 lbs / 75 kg). Matrix can be applied in one go for a full target plate. Completely flexible use of sample spots on MALDI target, no waste of target area. Choose between yeast or bacteria sample type. Only one calibration spot required for up to 95 samples. Expanded research capabilities with the negative ion mode. Validated confirmation method in the food industry 4.0. Seamless integration of custom spectra into the routine workflow 6. Compatibility with CDC MicrobeNet database. Seamless integration with FT-IR technology for strain typing. Background The current mass spectrometer is end-of-support from the vendor and will need to be upgraded to a new system that is hosting a supported operating system. The tuberculosis lab is a critical service line for VA Connecticut, as well as other external entities for performing required lab analyses. If the current mass spectrometer goes down, the tuberculosis lab s operations are down, which causes significant delays in throughput for lab analyses requiring TB lab support. Scope The vendor will provide white-glove installation and configuration services for the mass spectrometer, ensuring every detail is taken care of. This includes cleaning, adjustments, lubrication, calibration, and more. A field service engineer will travel to the West Haven VA to perform these installation activities, equipped with the necessary test/spare equipment and tools. The vendor will make sure the equipment is in good working order under normal conditions of use, in strict accordance with the manufacturer s specifications. The vendor will collaborate with biomedical engineering and laboratory information managers to ensure a seamless connection to the Laboratory information system. Most importantly, the vendor will provide comprehensive end-user training and certification, empowering the lab personnel responsible for the system's operation with the necessary skills and knowledge. Applicable Directive n/a Performance Requirements The contractor s responsibilities will include the following: White Glove Installation Service This includes a lift-gate delivery, unpacking of materials, debris removal, inside and in-place delivery, and a two-person delivery. This also includes installation and configuration services for ensuring the system is ready for clinical use. Deliverables Provide all necessary operator and maintenance manuals. Complete a planned maintenance program during installation. Complete documentation of services and provide it to the site after installation of the new system has been completed. Provide education and certification training for up to five employees. Security Clauses N/A 8.0 Hours of Performance Delivery shall occur Monday through Friday 8:00 AM to 4:00 PM EST. The same hours of performance should apply for all installation services. 9.0 Place of Performance Department of Veteran Affairs West Haven VA Medical Center Tuberculosis Lab 950 Campbell Avenue, West Haven, VA 06516 10.0 Check in Requirements The Field Service Engineer must report to the Biomedical Engineering Department to obtain a badge and sign in with the Biomedical Engineering Service before work begins. Submit any mobile media devices that would be used on the system to a virus scan. Upon completion of work, the Field Service Engineer must report to the Biomedical Engineering Service to sign out and brief Biomedical Staff or Supervisor if Biomedical Staff is unavailable concerning completion of service. At the end of briefing Field Service Engineer will return the badge and sign out in the Biomedical Engineering Department. 11.0 Documentation Contractor shall furnish a detailed field service report upon completion of work to Biomedical Staff in the Biomed Department. Payment will not be processed until a properly completed service report is received. The service report shall contain, at a minimum, the following information: Type, model, System ID, and serial number (s) of all equipment on which maintenance was performed. Total time spent performing maintenance. Detailed narrative description of the services required. Copies of all test reports Complete list of parts replaced (when applicable) Date and time the repair/support was completed. The service report shall itemize every item in the specification. Each item shall state the "as found" condition or values, the "calibrated to" or "adjusted to" values, the factory design tolerances, and a complete description of all work performed concerning the items. Included will be a list of new parts used and recommended future repairs. Records Management Language for Performance Work Statement (PWS) The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor during performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. GENERAL RULES OF BEHAVIOR a. Rules of Behavior are part of a comprehensive program to provide complete information security. These rules establish standards of behavior in recognition of the fact that knowledgeable users are the foundation of a successful security program. Users must understand that taking personal responsibility for the security of their computer and the information it contains is an essential part of their job. b. The following rules apply to all VA contractors. I agree to: (1) Follow established procedures for requesting, accessing, and closing user accounts and access. I will not request or obtain access beyond what is normally granted to users or by what is outlined in the contract. (2) Use only systems, software, databases, and data which I am authorized to use, including any copyright restrictions. (3) I will not use other equipment (OE) (non-contractor owned) for the storage, transfer, or processing of VA sensitive information without a VA CIO approved waiver, unless it has been reviewed and approved by local management and is included in the language of the contract. If authorized to use OE IT equipment, I must ensure that the system meets all applicable 6500 Handbook requirements for OE. (4) Not use my position of trust and access rights to exploit system controls or access information for any reason other than in the performance of the contract. (5) Not attempt to override or disable security, technical, or management controls unless expressly permitted to do so as an explicit requirement under the contract or at the direction of the COTR or ISO. If I am allowed or required to have a local administrator account on a government-owned computer, that local administrative account does not confer me unrestricted access or use, nor the authority to bypass security or other controls except as expressly permitted by the VA CIO or CIO's designee. (6) Contractors use of systems, information, or sites is strictly limited to fulfill the terms of the contract. I understand no personal use is authorized. I will only use other Federal government information systems as expressly authorized by the terms of those systems. I accept that the restrictions under ethics regulations and criminal law still apply. (7) Grant access to systems and information only to those who have an official need to know. (8) Protect passwords from access by other individuals. (9) Create and change passwords in accordance with VA Handbook 6500 on systems and any devices protecting VA information as well as the rules of behavior and security settings for the particular system in question. (10) Protect information and systems from unauthorized disclosure, use, modification, or destruction. I will only use encryption that is FIPS 140-2 validated to safeguard VA sensitive information, both safeguarding VA sensitive information in storage and in transit regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA. (11) Follow VA Handbook 6500.1, Electronic Media Sanitization to protect VA information. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders. (12) Ensure that the COTR has previously approved VA information for public dissemination, including e-mail communications outside of the VA as appropriate. I will not make any unauthorized disclosure of any VA sensitive information through the use of any means of communication including but not limited to e-mail, instant messaging, online chat, and web bulletin boards or logs. (13) Not host, set up, administer, or run an Internet server related to my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA unless explicitly authorized under the contract or in writing by the COTR. (14) Protect government property from theft, destruction, or misuse. I will follow VA directives and handbooks on handling Federal government IT equipment, information, and systems. I will not take VA sensitive information from the workplace without authorization from the COTR. (15) Only use anti-virus software, antispyware, and firewall/intrusion detection software authorized by VA. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with VA. (16) Not disable or degrade the standard anti-virus software, antispyware, and/or firewall/intrusion detection software on the computer I use to access and use information assets or resources associated with my performance of services under the contract terms with VA. I will report anti-virus, antispyware, firewall or intrusion detection software errors, or significant alert messages to the COTR. (17) Understand that restoration of service of any VA system is a concern of all users of the system. (18) Complete required information security and privacy training, and complete required training for the particular systems to which I require access. PRIVACY Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS). As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA. Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request. Information Technology Security Requirements: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract. The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required. Security Statement: Sensitive VA information is contained within the systems covered by this contract. Biomedical Engineering shall perform virus scans on all removable media prior to use on VA medical equipment. This includes all types of removable media, including media (e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by VA, and media brought in by vendors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program. The Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information. During onsite service, the Vendor shall be chaperoned by VA Personnel. However, the vendor shall not be issued a User ID/Password. Non-volatile memory devices, working or non-working, shall NOT be removed from the VA Medical Center until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media. 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 (November 2023) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (May 2024) The following subparagraphs of FAR 52.212-5 are applicable: 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub L. 117-328) 52.209-6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021) (31 U.S.C. 6101 note). 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (NOV 2023) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627) 52.225-5, Trade Agreements (NOV 2023) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) (31 U.S.C. 3332) 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021) (a) The offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled "Trade Agreements." (b) The offeror shall list as other end products those supplies that are not U.S.-made or designated country end products. Other End Products Line item No. Country of origin [List as necessary] (c) The Government will evaluate offers in accordance with the policies and procedures of Part 25 of the Federal Acquisition Regulation. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for those products are insufficient to fulfill the requirements of this solicitation. (End of Provision) All quoters shall submit the following: Please include the solicitation number in the subject line of the email response to ensure RFQ is present. 52.225-6 Trade Agreement Certificate must be filled out; otherwise, your quote will not be considered in this solicitation. All quotes shall be sent to the Veterans Health Administration, Regional Procurement Office East, Network Contracting Office 1 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: Technical, Speed of Delivery, Price The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR. The following provision is incorporated into 52.212-1 as an addendum to this solicitation: FAR 52.212-1 Instructions to Offerors Commercial Products and Commercial Services (Nov 2021) (a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the Request for Quote (RFQ). However, the small business size standard for a concern that submits a quote, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition Is set aside for small business and has a value above the simplified acquisition threshold; or Uses the HUBZone price evaluation preference regardless of dollar value, unless the quoter waives the price evaluation preference; or Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value. (b) Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified. Quotes may be submitted on letterhead stationery, or as otherwise specified in the RFQ. As a minimum, quotes must show            (1) The solicitation number;            (2) The time specified in the solicitation for receipt of quotations;           (3) The name, address, and telephone number of the quoter; A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;            (5) Terms of any express warranty;            (6) Price and any discount terms;            (7) "Remit to" address, if different than mailing address; (8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the quoter shall complete electronically);            (9) Acknowledgment Request for Quotation amendments; (10) Past performance will not be considered in simplified acquisition procurements. (11) Quote should include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes that fail to furnish required representations and certifications, information requested in (1) to (9), and a...