VA HANDBOOK 6500.6 APPENDIX C MARCH 12, 2010 APPENDIX C C-10 C-11 NOTICE OF INTENT TO SOLE SOURCE: The Department of Veterans Affairs Network Contracting Office 4, intends to award a sole source, Firm-Fixed-Price Contract to Welch Allyn Inc. for the provision of Connex Premium Service Support and Licenses for Welch Allyn Vital Sign Monitors. Services to be located at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC), located at 3900 Woodland Avenue, Philadelphia, PA 19104 This contract action is for services for which the Government intends to solicit from only one source under the authority of FAR 13.106, Justification for Single Source Award. Interested parties may identify their interest and capability to respond to the requirement or submit proposals. The North American Industry Classification System (NAICS) for this requirement is 541511 with a small business size standard of $30 million. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. Responsible sources may identify their interest by submitting capability information by 8:00 AM EST, on Monday, November 8, 2021, in order to establish the ability of the source to meet this requirement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs associated with the preparation of responses to this notification. All inquiries and submittals must be sent via email to Justin Erdley, Contract Specialist, at
[email protected]. Telephone inquiries will not be accepted. Statement of Work (SOW) GENERAL GUIDANCE Title: Connex support agreement for VA Philadelphia Medical Center owned Welch Allyn vital sign monitors. Scope of Work: The contractor shall provide software updates/upgrades, Connex licenses, Connex monitoring dashboard, 7x24x365 telephone diagnostic, and onsite support for the government owned Welch Allyn Vital Sign Monitors required by the requirements stated herein. The facility is located at: Philadelphia VA Medical Center (VAMC) 3900 Woodland Ave Philadelphia, PA 19104 Background: This contract is issued to ensure the continuous reliability of the Welch Allyn Vital Sign Monitors identified in this SOW. The units require annual software and licensing support. These units are critical for continuous patient care at the VA Philadelphia Medical Center. The reliable and accurate operation of the equipment at all times is considered critical to the health of patients. Performance period: Base year, 12/01/2021 11/30/2022 Type of Contract: Firm-fixed-price. B. GENERAL REQUIREMENTS This agreement includes all hardware support, software updates including licenses, and remote (telephone support), and onsite diagnostic support for the Welch Allyn Vital Sign Monitors for continuous reliability. Equipment to be serviced: Each of the following items are to be serviced in accordance with the specifications, terms and conditions of this contract. Line Item Manufacturer Description Model Quantity 1. Welch Allyn Vital Signs Monitor CONNEX SPOT 320 Software and Licenses Software patches and quality updates/upgrades are included under the terms of this contract and shall be applied in accordance with manufacturer specifications. Any licensing required to automate the delivery of vital sign documentation from Welch Allyn vital sign monitors to the electronic medical record (EMR) will be included in this contract. Remote Service The contractor must be able to provide 7x24x365 telephone diagnostic support as needed by phone for the equipment owned by VA Philadelphia. Personnel with OEM equipment training will respond directly by phone. If situations are responded to by phone and do not resolve the service issue, OEM trained personnel will be required for an on-site visit. This does not include direct access to the server, only the vital signs monitors themselves. If the contractor cannot remediate the issues the Biomedical Engineering Designee shall be notified immediately and provided an estimated time for resolution. Hours of Coverage: The contractor will provide any on-site services within the normal business hours (8:00 AM to 8:00 PM (EST) M-F), excluding holidays. On-site services are limited to the machines themselves, not the server. These services shall be performed during these normal hours of coverage unless one of the following conditions exists: The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to Biomed Engineering prior to the proposed start of the work, and the request is approved in writing before work is begun. The technical point of contact in Biomed Engineering directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended authorized by the CO. Technical support shall respond to calls 24 hours a day, 7 days a week and all holidays. This would include over the phone diagnostic and troubleshooting of the entire system. Work performed outside the normal hours of coverage must be preapproved by the CO. The Contractor will provide a written estimate of the charges prior to approval of the work. Work performed outside the normal hours of coverage at the request of FSE/contractor shall be considered service performed during normal hours of coverage. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts Note: Hardware/software update/upgrade installations for the vital signs monitors shall be scheduled and performed during normal hours of coverage at no additional charge to the government. Federal Holidays Observed by the VA Medical Center New Year s Day, Martin Luther King, Jr. Day, President s Day (Washington s birthday), Memorial Day , Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States. Customer Notification: Contractor shall notify Biomedical Engineering and the Police service when they arrive on site (Biomedical Shop Room 33A152, building 2). Contractor will schedule all services with Biomedical Engineering. All vendor mobile media devices (USB drives, CDs, DVDs, etc.) must be scanned by Biomed before use. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s) per Section E. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s). All ESRs shall be submitted to the equipment user for an acceptance signature and to Biomed for an authorization signature. If a signature is not available, a signed accepted copy of the ESR will be sent to the point of contact in Biomed within five business days of work completion. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT. C. DEFINITIONS/ACRONYMS: Biomedical Engineering Supervisor or designee, Phone Number (215) 823-5800 x2473 CO Contracting Officer. COR Contracting Officer s Representative. PM Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer s latest established service procedures to ensure operation of equipment within manufacturer s or VA s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM. FSE Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Medical Center premises. ESR Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract. Acceptance Signature VAPHI employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR. Authorization Signature COR s signature; indicates COR accepts work status as stated in ESR. NFPA National Fire Protection Association. CDRH Center for Devices and Radiological Health. VAPHI Department of Veterans Affairs Philadelphia Medical Center. OEM Original Equipment Manufacturer CEU Continuing Education Credit D. CONFORMANCE STANDARDS: Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA. E. DOCUMENTATION/REPORTS: The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. ESR s must also be emailed to
[email protected], with the Vendor Name and contract Obligation Number listed in the Subject Line. In addition, each ESR must at a minimum document the following data legibly and in complete detail: Name of Contractor Name of FSE who performed services. Contractor Service ESR Number/Log Number. Date, Time (starting and ending), Hours-On-Site for service call. VA Purchase Obligation (PO) number covering the call, if outside normal working hours. Description of Problem Reported by COR/User. Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action. Total price to be billed. Signatures from the following: FSE performing services described. VA Employee who witnessed service described. Equipment downtime calculated in accordance with Conformance Standards. Note: Any additional charges claimed must be approved by the CO before service is started. F. SCHEDULE FOR DELIVERABLES Draft copies of deliverables shall be provided to Biomedical Engineering staff before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable. G. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. H. CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in this scope of work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract. I. CONTRACTOR EXPERIENCE REQUIREMENTS Each respondent must have an authorized distributor of the original equipment manufacturer. Contractor personnel coming on-site must provide a copy of: 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate. 4) See COVID-19 Protocols listed below. J. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD: The contractor shall comply with the Federal OSHA Bloodborne Pathogens Standard. The contractor shall: Have methods by which all employees are educated as to risks associated with bloodborne pathogens. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract. K. INFLUENZA PREVENTION PROGRAM: VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Healthcare personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. Those HCP unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: Documentation of vaccination, e.g., signed record of immunization from a healthcare provider or pharmacy, or a copy of medical records documenting the vaccination. Completed Healthcare Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification to the Contracting Officer s Representative (COR) or designee that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192. L. COVID-19: Upon entering the VAMC, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by the Government. All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement. VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors Contractor employees who work in or travel to VHA locations must comply with the following: Documentation requirements: If fully vaccinated, shall show proof of vaccination NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor s order or an FDA approved over-the-counter test. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the following website: COVID-19 Screening Tool. Regularly check the website for updates. Contractor employees who work away from VA locations, but who will have direct patient contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities. M. CONFIDENTIALITY AND NONDISCLOSURE: It is agreed that: The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. N. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS: The contractor's FSE shall wear visible identification at all times while on the premises of VAPHI. Identification shall include, as a minimum, the employee s name, position, and the contractor s trade name. 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. VAPHI will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings and on premise at VAPHI. This covers all smoking and tobacco products, including but not limited to: Cigarettes Cigars Pipes Any other combustion of tobacco Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars. Chewing tobacco 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. O. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS This language is still in draft form. The OI Service Center is reviewing alternative sources for background investigations. The language included in this draft is based on last year s contract. Language must be updated to match App A for 642-21-1-088-0008 signed by ISOs. Contractor may not have access to the VA network or any VA sensitive information under this contract. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT. The following language from VA Handbook 6500.6 is required in this contract: Appendix B: all, Appendix C: Section 1, 2, 3, 5, 6, 7, 8, 9. All Contractors must receive Privacy training annually using one of the following methods: Complete VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information training by using VA s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR or designee must ensure that all contractors are validated in the PIH domain. Complete the hard copy version of VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information . Signed training documents must be submitted to the COR or designee. END OF NOTICE OF INTENT TO SOLE SOURCE