SOLICITATION NOTICE
66 -- Phadia 250 immunoassay analyzer
- Notice Date
- 4/24/2025 12:06:45 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24125Q0385
- Response Due
- 4/30/2025 3:00:00 AM
- Archive Date
- 05/15/2025
- Point of Contact
- Fred Revah, Phone: 2076238411, Cynthia Thompson, Phone: 60362443665842
- E-Mail Address
-
frederic.revah1@va.gov, Cynthia.Thompson2@va.gov
(frederic.revah1@va.gov, Cynthia.Thompson2@va.gov)
- Small Business Set-Aside
- SDVOSBS Service-Disabled Veteran-Owned Small Business (SDVOSB) Sole Source (FAR 19.14)
- 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 2025-03 January 17, 2025 This solicitation is set-aside for Service-Disabled Veteran Owned Small Business (SDVOSB) The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a small business size standard of 1000 employees The FSC/PSC is 6632. The Department of Veterans Affairs, VISN 01, Network Contracting Office 1, in support of Providence VA Medical Center, Providence RI 02908-4734 is seeking to purchase a Thermo Fisher Phadia 250 immunoassay analyzer for allergy testing. All interested companies shall provide quotations for the following: Supplies/Services CLIN 0001 Phadia 250 immunoassay analyzer - 12390001P 1 ea STATEMENT OF WORK SCOPE OF WORK: Phadia 250 instrument to perform ImmunoCAP (allergen) and EliA (autoimmunity) lab tests are run on fully the automated Phadia 250 Laboratory System, designed to deliver accurate and reproducible test results. Phadia uses advanced techniques such as recombinant allergen technology to develop the latest standardized, precise, reliable, and easy-to-use diagnostic tests including testing for 500+ allergens (done via measuring the specific response of antibodies to allergens) and 50+ autoimmunity markers (including for rheumatoid arthritis, antiphospholipid syndrome, thyroid disease, etc.). This system will offer the Providence VAMC the opportunity to be the first allergy testing site in VISN 1. It will provide testing for all the sites across the VISN. The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following: Installation and implementation of a fully functional Phadia 250 System inclusive of Phadia 250 Instrument Uninterrupted Power Supply Computer cart All shipping, delivery, and installation necessary to make the system operable Clinical Training for Providence VA Medical Center staff. Technical Training for Providence VA Medical Center staff. 1. EQUIPMENT The following equipment shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable. The Phadia 250 allergy analyzer offers a fully automated testing process with a menu of 500+ allergies available for testing, as well as testing for autoimmunity markers. The system is capable of running multiple tests from a single patient sample. The system software offers robust result collection and analysis. The Phadia 250 system offers a throughput of 60 tests an hour and is able to fully integrate into the existing Lab Information System. The system also offers temperature-controlled reagent storage. The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation. 2. SALIENT CHARACTERISTICS The Contractor shall provide a fully functional system that meets the following characteristics: Integration with current Lab Information System (Data Innovations) Fully automated dispensing, processing, and measuring capabilities Wide allergen and allergen component testing menu Autoimmunity testing capabilities Testing capacity of 60+ tests/hour 10 to 20-position sample racks Analyzer dimensions (H/W/D): 74x58x37 in Power requirements: 120v/120amp Refrigerated on-board reagent storage 28-day stored calibration curve Onboard dilutions 2. AREAS TO BE SERVICED Department of Veterans Affairs Providence VA Medical Center Lab and Pathology 830 Chalkstone Ave Providence, RI 02908 3. INSTALLATION The Contractor shall provide all labor, materials, tools, equipment etc. to prepare for and complete the installation of the equipment in the space determined by the Government. Project implementation meetings, if necessary, shall be coordinated with the COR. Installation and implementation dates are to be coordinated in advance with the Contractor and the COR. All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access. All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government. All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work. The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing of the Phadia 250 system. If the Contractor is unable to install the equipment to its normal operational state within 24 hours, the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment. The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable. The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation. 4. TRAINING The Contractor shall provide a comprehensive onsite training program for the operating clinicians. This training program shall include at the minimum the following sessions: (i) Technical Training, (ii) Operational Training, (iii) Administrative Training, and (iv) Hardware and Software Trouble-shooting. Training shall occur onsite during normal business hours, 7:00am-3:30pm, Monday through Friday. Competency assessments shall be provided with the training. Onsite training is to be scheduled in advance with the Providence VA Medical Center through the COR. The Contractor shall provide onsite general overview technical training for Clinical Engineering personnel as requested. Training shall include a technical overview of the mechanics, electronics, and general operations of the system. Training shall cover detailed instruction regarding the preventative maintenance, troubleshooting, and general maintenance of the equipment. 5. INSPECTION AND ACCEPTANCE The Contractor shall conduct a joint inspection with the COR upon delivery of equipment. Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. 6. WARRANTY The contractor shall provide a one year manufacturer�s warranty on all parts and labor. The warranty shall include all travel and shipping costs associated with any warranty repair. 7. TASK FREQUENCY AND INSTRUCTIONS The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR. Equipment delivery shall not precede installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including �go live� support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award. 8. SPECIAL WORK REQUIREMENTS The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work. The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work. 9. PROPERTY DAMAGE The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer. 10. ATTACHMENTS None. 11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court. 12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall: A. Have methods by which all employees are educated as to risks associated with blood borne pathogens. B. Have policies and procedures which reduce the risk of employee exposure to blood borne pathogens. C. Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens. D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, and mouthpieces for the employee during performance of the contract. 13. INFORMATION SECURITY LANGUAGE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor�s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. 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 on site 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 in the course of 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. 9. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document � e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. 10. Records Management Language for Statement of Work (SOW): 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 The purchase order period of performance is no later than 180 days after receipt of order (ARO). Place of Performance/Place of Delivery Providence VAMC 830 Chalkstone Avenue Providence, RI 02908-4734
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/513115c99b904f3eaeda586c034a34ff/view)
- Place of Performance
- Address: Providence, RI 02908, USA
- Zip Code: 02908
- Country: USA
- Zip Code: 02908
- Record
- SN07421125-F 20250426/250424230053 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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