SPECIAL NOTICE
J -- Cleveland Plethysmographs Preventive Maintenance Intent to Sole Source
- Notice Date
- 10/10/2023 12:11:08 PM
- Notice Type
- Special Notice
- NAICS
- 811210
—
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25024Q0038
- Response Due
- 10/13/2023 7:00:00 AM
- Archive Date
- 11/12/2023
- Point of Contact
- Michael E. Groneman, Contracting Officer, Phone: 513-559-3720
- E-Mail Address
-
Michael.Groneman@va.gov
(Michael.Groneman@va.gov)
- Awardee
- null
- Description
- The Department of Veteran Affairs, Veterans Health Administration, Network Contracting Office 10, Cincinnati OH 45219, intends to negotiate a sole source, Firm-Fixed Price Contract for Plethysmographs Preventive Maintenance to Medical Graphics Corporation, 350 Oak Grove Parkway, Saint Paul, MN 55127 in accordance with FAR Subpart 13.2. This acquisition is for the Louis Stokes Cleveland OH VAMC, 10701 East Blvd, Cleveland, OH 44106. The Government intends to award the contract to Medical Graphics Corporation 350 Oak Grove Parkway, Saint Paul, MN 55127. SAM UEI: Q285F28T7UF2. This notice satisfies the requirement at FAR 5.201(b)(1), requiring publication of the proposed contract action. This notice of intent is not a request for quote and no solicitation shall be made available. IAW FAR 5.207(c)(16)(ii) Contractors may submit a capabilities statement or quotation which shall be considered by the agency. The government shall not pay for any costs incurred by responses to this notice. Responses to this notice are due on or before Friday, October 13th at 10:00 a.m. Eastern Time to Michael Groneman, Contracting Officer, via email at Michael.Groneman@va.gov and Sara.Wood1@va.gov. STATEMENT OF WORK (SOW) Contracting Officer s Representative (COR). Name: Katherine Troll Section: Engineering Service 138(A) Address: 10701 East Blvd Cleveland Ohio 44106 Phone Number: (216)791-2300 Ext 46165 Fax Number: (216)707-7624 E-Mail Address: Katherine.Troll@va.gov Technical Representative: Jeffrey.Reynolds@va.gov 2. Contract Title. Service agreement which includes maintenance and technologist application assistance, field service support for repair and preventive maintenance 3 PLATINUM ELITE DX Plethysmographs 3. Background. The Louis Stokes Cleveland Department of Veterans Affairs Northeast Ohio Healthcare System is requesting VISN 10 Contracting Activity to enter into an agreement for the maintenance and service of the (3) PLATINUM ELITE DX Plethysmographs. Contract is required to assure equipment is maintained to meet patient care needs, clinicians and technologist receive application support and equipment receives OEM required maintenance to meet accreditation requirements. The PLATINUM ELITE DX Plethysmographs are currently in use by the Pulmonary Department at the Louis Stokes Cleveland VA Medical Center (VAMC) to perform non-invasive pulmonary function testing on patients. Technical questions regard these items should be directed to the Biomedical Engineering Chief, Anthony Lelli and/or Biomedical Engineering Support Specialist Jeffrey Reynolds. 4. Scope. Provide maintenance service and technical support for a standard service place for the equipment listed below. This equipment type is critical and is used to provide direct patient care. It is essential to the operations of the Medical Center that this equipment be repaired properly and in a timely manner to ensure patient care and safety is not compromised. Description VA ID Serial # PLATINUM ELITE DX 541 MX2798243 243001339 PLATINUM ELITE DX 541 MX2798242 243001340 PLATINUM ELITE DX 541 MX2007663 243000723 5. Specific Tasks. The vendor shall respond to requests for service and technical support on the above stated equipment for a full year, with the option for the VA to exercise additional years as needed. Technical and application telephone assistance: The vendor s must have technical support desk toll free telephone# available M-F 8:00am-8pm EST to provide assistance with answering technical instrument, software, and application questions at no additional charge. On-site field service and support. Unlimited field service and support is provided by OEM trained authorized service engineers. All vendor engineers must possess OEM training certifications and are experts on the systems listed in the Scope section. Unlimited service visits M-F 8:00am-8pm EST. Response time for onsite emergency: Once technical support desk representative determines onsite field service is required onsite arrival is within 24 hours. Repair: No charge for on-site service, inclusive of labor, travel or expenses incurred during normal business hours (Monday thru Friday 8:00am-8pm EST local time - excluding Holidays). On-site field service can be arranged by calling vendor service toll free phone number. Parts: No charge for replacement parts which become marginal or defective due to normal use during agreement period. All parts are sourced from the OEM and are new or OEM certified remanufactured. Preventative Maintenance (PM) visits. Vendor performs PM. PMs increase instrument reliability minimizes down time and assures performance to OEM published specifications. The recommended annual PM is scheduled based on the instrument type. All PM inspections are performed at no additional charge during normal business hours. Vendor may determine if additional PM is required and perform additional PM at no additional charge. (Such as, high volume, or other instrument performance issues indicating the need for additional preventive maintenance) Equipment Updates: Vendor provides all OEM authorized-product updates including all operation modifications, hardware and platform operating software enhancements for contracted equipment for improved product performance and reliability. Cybersecurity: Vendor installs all OEM authorized IT security patching, including software revisions and updates. Parts Inventory: Vendor possesses extensive Field Service parts Inventory. vendor engineers carry most commonly used parts for first time repair. Parts Distribution: Vendor has a national distribution system to provide prompt delivery of low usage repair parts typically overnight. Calibration: Vendor must provide all calibration fixtures, software, maintenance supplies, tools, and other standards. 6. Performance Monitoring Clinical team shall communicate with assigned Biomedical Engineering Support Specialist (BESS), all identified issues with the servicing of equipment involved with this maintenance and repair including software updates and security patching to ensure that vendor provides high quality and efficient service and is able to fulfill its obligations under this agreement. The Field Service Engineer must report to the Biomedical Engineering Department to sign in with the Biomedical Engineer before the work begins. Upon completion of work, the Field Service Engineer must sign out with Biomedical Engineering and brief the Biomedical Engineering staff concerning completion of service. Electronic notification to check with Biomedical Engineering is also acceptable by sending email to vhaclebme@va.gov, subject onsite service reporting and include the equipment name, serial number, or equipment site ID# and location. Documentation/Reports: All services performed by the vendor are documented and all reports are electronically mailed within a week to: vhaclebme@va.gov Biomedical Engineering shall document all repairs and maintenance completed on this equipment in the Maximo Asset record. Dedicated personnel will be assigned solely to observe, interact assist and assure protection of VA sensitive information. 7. Delivery Schedule Requested delivery schedule is 11/03/2023-11/02/2024. 8. Security Requirements Service & Maintenance will follow the security requirements as per VA s Medical Device Protection Program (MDPP) which protects VA s medical devices through a comprehensive security initiative that encompasses pre-procurement assessments, medical device isolation architecture (MDIA), communication, validation, scanning, access control list remediation, patching, and secure remote connectivity. 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. The C&A (Certification and Accreditation) requirements do not apply, and that a Security Accreditation Package is not required. Access to VA Information and VA Information Systems 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. The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured. 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 se curity 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. A BI is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies: Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff. VA Information Custodial Language 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). 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. Information Systems Hosting, Operations, Maintenance, or Use Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. Security Incident Investigation The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. Liquidation Damages For Data Breach Consistent with the requirements of 38 U.S.C. ยง5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports. Data breach analysis. Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution. One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. System Interconnection Any VA External Computer System interconnections between VA Systems on the VA Network and VA Business Partner Systems residing outside the VA Network will require a signed Memorandum of Understanding (MOU) and Interconnection Security Agreement (ISA) collectively known as MOU ISA between the VA and the VA Business Partner. 9. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). There shall be no Government-Furnished Equipment or Government Furnished Information provided to the vendor. 10. Other Pertinent Information or Special Considerations. Identification of possible follow-on work. Possible follow-on work includes possible contact with the vendor for service agreement inquiries. Identification of Potential Conflicts of Interest (COI). There are no known Conflicts of Interest at this time. All vendor engineers possess OEM training certifications and are experts on the systems listed in the Scope section. Identification of Non-Disclosure Requirements. The vendor may have access to any VA patient sensitive information or proprietary information. Inspection and Acceptance Criteria. Completion of all work is subject to the approval of the laboratory technologist and the Biomedical Engineering Section personnel. In addition, the documentation of the work is subject to approval by both representatives of both services. When the work is deemed satisfactory and documentation is provided, representatives of both services will indicate their approval on the vendor service sheets prior to the vendor s departure 11. Place of Performance. Cleveland Department of Veteran s Affair Medical Center located at 10701 East Blvd. Cleveland, Ohio 44106. 12. Period of Performance. 11/03/2023-11/02/2028 13. Type of Contract: Firm fixed price. 14. Hours of Coverage: Standard business hours are Monday through Friday from 8:00 am to 5:00 pm, excluding holidays. All service/repairs will be performed Monday through Friday from 8:00 am to 10:00 pm unless requested or approved by Chief of Biomedical Engineering, or their representative. All preventive maintenance shall be completed after clinical hours (Monday through Friday after 5pm, or weekends). Federal Holidays observed by the VAMC are: New Years' Day Martin Luther King Day Presidents' Day Memorial Day Independence Day Labor Day Columbus Day Veterans' Day Thanksgiving Day Christmas Day 15. Condition of equipment: The Contractor accepts responsibility for the equipment 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.
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- Record
- SN06855948-F 20231012/231010230119 (samdaily.us)
- Source
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