Inactive Total Small Business Set-Aside (FAR 19.5)

Combined Synopsis-Solicitation for Commercial Products and Commercial Services Effective Date: 03/15/2023 Revision: 01 Description This is a combined synopsis/solicitation for commercial products and ... Combined Synopsis-Solicitation for Commercial Products and Commercial Services 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 FAC 2024-05. This solicitation is set-aside for SMALL BUSINESS The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1,000 Employees. The FSC/PSC is 6540. This is a brand name only requirement. The Contracting Activity intends to purchase delivery and installation of (36) Welch Allyn Green Series 777 Integrated Wall Systems (Model No. 777-PM3WAS-US) manufactured by OEM LB BAXTER HEALTHCARE CORPORATION for Newington VA Clinic, 555 Willard Avenue Newington, CT 06111-2631. Under this proposal, the vendor shall provide all equipment, accessories, operator and service training, manuals, and installation service for the Welch Allyn Green Series 777 Integrated Wall System. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure 777-PM2WAX-US Welch Allyn GreenSeries 777 Integrated Wall System with Pan Optic Basic LED Ophthalmoscope, MacroView Basic LED Otoscope, BP Aneroid, and Ear Specula Dispenser 36 EA Statement of Work (SOW) Transaction #: 689-24-4-7042-0244 General: This document highlights the technical specifications and services being requested by the VA Connecticut Healthcare System for consideration towards the purchase of thirty-six (36) Baxter Welch Allyn Green Series 777 Integrated Wall System for Primary Care at VA CT Healthcare System for Newington VA CBOC. The Welch Ally Integrated Wall System houses all essential medical diagnostic tools within reach such as Ophtalmoscops, Otoscope, and Blood pressure aneroid intended to provide efficient and effective diagnostic are to the primary care patients at the new primary care clinic areas at the Newington VA CBOC. Background/Justification: The purchase of thirty-six (36) Welch Allyn Green Series 777 Integrated Wall systems with peripheral diagnostic equipment is being requested for Ambulatory Care s new primary care clinic at the Newington VA CBOC. The primary care clinic uses the medical diagnostic tools on the integrated wall system to treat and care for patients. Without this system, the primary care clinic cannot perform its functions. The wall system is configured to the primary care area s needs and allow for reliable diagnostic patient data in a standardized and energy efficient solution to improve patient care and safety. Description of Work: Under this proposal, the vendor shall provide all equipment, accessories, operator and service training, manuals, and installation service for the Welch Allyn Green Series 777 Integrated Wall System. The vendor shall provide all required service labor, travel, and parts for the Welch Allyn Green Series 777 Integrated Wall System required for it to function normally and safely prior to first patient use. All services performed shall be in accordance with the original equipment manufacturer (OEM) specifications. Product delivery will be the responsibility of the vendor working with the CT VAMC warehouse POC to delivery to the Newington VA CBOC. Summary of Service & Equipment Specifications: Equipment, Labor, Travel, Delivery & Installation for Welch Allyn Green Series 777 Integrated Wall System will be provided by vendor including but not limited to the below items: (36) 777-PM2WAX-US Welch Allyn Green Series 777 Wall System with PanOptic Basic LED Ophthalmoscope, MacroView Basic LED Otoscope, BP Aneroid, and Ear Specula Dispenser Delivery & Installation 12-month standard warranty Clinical applications training Hours of Performance: Normal hours of coverage are Monday through Friday 8:00 AM to 6:00 PM EST excluding federal holidays. All service will be performed during normal hours of coverage unless requested or approved by the Contracting Officer s Representative (COR). Federal Holidays observed by the VAMC are: New Year s Day Martin Luther King Day Presidents Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus/Indigenous People s Day Veterans Day Thanksgiving Day Christmas Day NOTE: Hardware installations will be scheduled and performed at a mutually agreed upon time at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR or designated representatives). Government provides hardware. There shall be no additional charge for time spent at the site during or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts. Training Provided / Training Materials: On-site clinical applications training for technologists during go-live On-site follow-up clinical applications training for clinical staff On-site clinical applications training for physicians during go-live Technologists who complete the clinical applications training shall receive continuing education credits (CMEs) Vendor shall be responsible for accommodating different personnel shifts for clinical applications training during go-live Vendor to provide all appropriate training materials and equipment manuals for proper end user training and reference Service Requirements: Vendor is encouraged to include any offerings for service, warranty, and training that may exceed the minimum requirements, to include information on their service support structure during and after the warranty period. Service and Operator Manuals The vendor shall provide the following documentation for the proposed systems: Two (2) copies of operator instruction manuals (one (1) electronic and one (1) physical copy) Two (2) copies of a service manuals (one (1) electronic and one (1) physical copy) *Vendors can include the physical copy as a priced line item in their quote as applicable. Minimum Warranty The system and accessories shall be covered under the manufacturer s warranty and shall include all parts and labor for one year following acceptance by the VAMC. This warranty must include PMs as required by the manufacturer. The manufacturer s factory-trained field service representatives shall perform installation and maintenance during the warranty period. Vendor is to offer technical training to the healthcare technology management (HTM) department for future service of procured devices. Conformance Standards: Contractor shall provide service and ensure that the equipment functions in accordance with the equipment manufacturer s technical performance specifications. Contractor shall conform to all regulations to include but not be limited to federal, state, and local governing any chemicals, equipment or work which may be used or performed in the work under this contract. Parts Exchange: All parts required for the installation of the system (excludes instruments and accessories) are covered. Part Protection: Preferred pricing on repairs or replacement due to accidental damage. Labor & Travel Expenses: All labor and travel conducted during normal business hours: Monday through Friday, 8:00 AM to 6:00PM EST (excludes vendor company holidays) are covered. Certified Trained Technicians and Key Personnel: Technicians shall include fully qualified Facility Service Engineers (FSE) and a fully qualified FSE who will serve as the backup and show proof of competency, as shown by training conducted on said system. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in this statement of work. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance. Proof of training shall be provided upon demand and be immediately sent via fax, upon demand to the COR. All FSE s and technicians shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSE's. The COR and/or designated representative specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment. It is anticipated that any hospital regulatory inspections (TJC, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device- system, at the time of the maintenance event. Service Manuals/Tools/Equipment: All required service manuals, tools, and equipment are to be provided by the vendor. 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. 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: Identification of equipment to be serviced: VA EE Number Vendor Inventory ID number Manufacturer Name Device Name Model Number Serial Number System ID Name of contractor and contract number Name of FSE who performed services Contractor service ESR number/log number Date, time (starting and ending), equipment downtime and hours on-site for service call VA purchase order number(s) covering the call if outside normal working hours Total time spent performing maintenance. Detailed narrative and itemized description of the services required and performed including: Labor and travel Parts (with part numbers) Materials Location Corrective Action Copies of all test reports Complete list of parts replaced (when applicable) Date and time the repair/support was completed Total Cost to be billed (if applicable i.e., part(s) not covered, or service rendered after normal hours of coverage). Signatures: FSE performing services described Authorized VA employee who witnessed service described NOTE: - Any additional charges claimed must be approved by the COR or designated representative before service is 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. Reporting Requirements: The Contractor shall be required to report to the Clinical Engineering Department to log in. This check- in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR or designated representative. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR or designated representative for an "authorization signature". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the user. Place of Performance: Department of Veterans Affairs VA Connecticut Healthcare System Newington VA Clinic 555 Willard Avenue Newington, CT 06111 Contracting Officer Representatives: Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the COR. All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer. 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, September 2007 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 West Haven 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 vendor will not have remote access to complete the repair(s) and preventive maintenance. 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. 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. Safety Requirements: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served to the Contractor or his representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contractor in default. Additional Charges: There shall be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts. Reporting Required Services Beyond the Contract Scope: The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the COR and/or designated representative (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish to the COR or designated representative a written estimate of the cost to make necessary repairs. Condition of Equipment: The Contractor shall accept responsibility for the equipment. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract. Test Equipment: Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to b...