Special Notice – Soring Equipment Service Maintenance

Notice Type: Special Notice

Posted Date: 24-SEP-16

Office Address: Department of the Navy; Bureau of Medicine and Surgery; Naval Medical Center San Diego; Bldg 134800 Bob Wilson Drive San Diego CA 92134-5000

Subject: Soring Equipment Service Maintenance

Classification Code: J - Maintenance, repair & rebuilding of equipment

Solicitation Number: N0025916N0229

Contact: Jeffrey P. Collins, Phone 6195328076, Email jeffrey.p.collins20.civ@mail.mil

Description: Department of the Navy

Bureau of Medicine and Surgery

Naval Medical Center San Diego

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. Reference #: N0025916N0229. Naval Medical Center San Diego intends to award a firm fixed price sole source contract under the authority of FAR 13.106-1(b)(1)(i), only one responsible source, to: Soring Group USA; 14401 West 65th Way Arvada, CO 80004-3599. The objective of this sole source award is to acquire service maintenance for government owned Sorin equipment. The contractor shall provide all services, labor, parts, materials, and equipment necessary for the service maintenance of government owned Sorin equipment in accordance with the statement of work. The government requests a base year and two option years. Base Year: Period of Performance: October 15, 2016 - October 14, 2017 Option Year 1: Period of Performance: October 15, 2017 - October 14, 2018 Option Year 2: Period of Performance: October 15, 2018 - October 14, 2019 Statement of Work Service and Maintenance for Government-owned Sorin Equipment 1. Scope: The contractor shall provide all services, labor, parts, materials, and equipment necessary for the service and maintenance for the government-owned Sorin Equipment as listed on Appendix A, "Government-owned Sorin Equipment" at Naval Medical Center San Diego (NMCSD). Contractor will service and maintain the equipment within the original equipment manufacturer's (OEM) specifications, in accordance with the US, State, and Local laws and regulations, US Navy regulations, and Joint Commission requirements. 2. Definitions: As used throughout this work statement, the following terms shall have the meaning set forth below: 2.1. Service and maintenance: (a) any modification, adjustment, or replacement of the equipment that corrects a malfunction and effectively brings the equipment into material conformity with the technical specification for that equipment as designated by the original equipment manufacturer (OEM), (b) a procedure or routine that, when observed in the regular, proper operation of the equipment, avoids the material adverse effect of the applicable nonconformity, (c) any measures performed that assure the continued operation of the equipment or returns the equipment to its designed efficiency and capacity, (d) replacement of a piece of equipment on a onefor- one basis in order to provide a substitute of equal or greater value in lieu of a damaged or defective device for compensation, return, or refund of equipment. 2.2. Contracting Officer (KO): A warranted representative of the federal government who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract. 2.3. Contracting Officer's Representative (COR): A Government employee appointed by the KO and responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract. 3. Location: Places of performance shall be: MAIN OPERATING ROOM Building 1, 4th Floor Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134-5000 and/or Biomedical Repair Department Building One, Ground Floor Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134-5000 4. Requirements: 4.1. General Performance Requirements: 4.1.1. The Contractor shall provide equipment maintenance services to include all periodic planned maintenance and unscheduled repairs in accordance with OEM specifications and in compliance with ISO 9001 standards, to include repairs necessitated by operator error. 4.1.2. The Contractor may use third party service vendors not limited to the Original Equipment Manufacturer (OEM), however, these vendors must be approved in advance by the COR. The Contractor must submit a list of any sub-contractors they intend to use as third party service vendors to the COR for approval. Third party service vendors shall not perform any work under this contract prior to such approval. 4.1.3. Ensure that only fully-qualified field engineers and/or technicians who have gone through OEM or equivalent third-party service schools for the equipment will be employed in the performance of any and all work performed under this contract. Service personnel will have sufficient experience to demonstrate proficiency in maintenance of the product. Upon request, Contractor will provide written assurance of the competency their personnel as well as a list of credentials for approved field service personnel. The KO and/or COR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time. 4.1.4. Test equipment: Test equipment calibration will be traceable to National Institutes of Standards and Technology (NIST traceable). Any efforts conducted without equipment within the calibration intervals is not performance in accordance with this contract. Upon request by COR, the Contractor and/or service vendors will provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on NMCSD equipment. 4.1.5. Field Service Reports: Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR) to the Duty Staff at NMCSD Biomed. All FSR's shall be submitted within 72 hours of _completion of service. The contractor or their representative shall complete the FSR to include, at a minimum, the following: 1. Contractor Name 2. Technician's printed name, telephone number, and signature 3. Date and Time of Arrival 4. ECN (to be provided by Navy) and Serial Number of Equipment 5. Time Expended Repairing/Service: Labor Hours, Rate, Materials 6. Summary of Work Performed and Accepted by End-User, with Government Representative's Printed name and Signature) Completed Field Service Reports are required prior to acceptance of any invoice. Failure to submit a Field Service Report to NMCSD Biomed can result in delay of payment or rejection of invoice from Government. It is highly recommended that the contractor attach a copy of the Field Service Report to their Wide Area Workflow. Invoice in addition to the required submission to NMCSD Biomed in order to expedite invoicing process. 4.2. NMCSD Preventive Maintenance Requirements: 4.2.1. Preventive maintenance will be performed in a manner which will minimize corrective maintenance and will include but is not limited to: calibration, adjustment, lubrication, updating software for security, safety, or system functionality issues, testing required to maintain a safe environment of care, electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance). 4.2.2. Make repairs to the extent necessary, as determined by inspection tests or disassembly, to ensure a functional system that will efficiently serve its intended purpose and the technical specification for that equipment as designated by the original equipment manufacturer. 4.2.3. Installation of system update changes to resolve specific product reliability problems. Hardware and software upgrades, defined as those changes that enhance or add product features, are not included. 4.2.4. Preventive Maintenance will be performed at a minimum of one (1) time per year, with these scheduled preventive maintenance actions performed during: October and November; to be coordinated with NMCSD BIOMED after contract award. 4.2.5. Preventive Maintenance Completion: Contractor must insure that 95% or more of all periodic maintenance is performed within 30 days of due date, and that 100% of periodic maintenance is performed within 60 days of the due date. 4.2.6. Equipment in Use: If, for reasons beyond the Contractor's control, equipment is not made available for maintenance for the entire 30 days before the maintenance due date, and 60 days following due date, the Contractor shall immediately notify the COR. 4.2.7. Equipment Unable to Locate (UTL): If the Contractor is unable to locate an item within the maintenance window specified, the Contractor shall immediately notify the COR. The COR may determine that the property has been disposed of or otherwise inactive or unavailable for use and may adjust the equipment covered under this Statement of Work accordingly. 4.2.8. 100% Preventive Maintenance: Under the circumstances of 4.2.6. and/or 4.2.7., the COR and Contractor shall arrange a means of complying with the requirements for preventive maintenance at no additional cost to the government. Equipment determined missing, lost, or stolen shall be exempt from maintenance. 4.2.9. Uptime Rate: The Contractor will maintain an overall uptime rate of 95% or better for all equipment covered by this effort. Individual uptime rate for specific equipment, if required, will be as specified on Appendix A. 4.2.10. Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance history with NMCSD, the uptime shall be calculated cumulatively for the entire duration of the contract. 4.3. NMCSD Corrective Maintenance Requirements: 4.3.1. Correct inoperable condition in a timely manner. Contractor will respond no later than two (2) hours after telephone notification from BIOMED, Monday-Friday,. between the hours of 0800-1600. 4.3.2. Provide only the work necessary to restore the equipment to a properly serviceable/operating condition by adjustments, replacement parts, or minor repairs when it is determined that extensive repairs and parts are not necessary. 4.3.3. Equipment improvements/modifications will be made only upon BIOMED written approval and direction. This includes software updates to the device. All updates/improvements/modifications performed will be notated on the field service report or equivalent. 4.3.4. Notify BIOMED immediately upon receipt of OEM safety recall notices or upon receipt of recall notices pertaining to any parts or materials utilized by contractor on the equipment. 4.3.5. Ensure that the original design and functional capabilities will not be changed, modified, or altered without express written authorization from BIOMED. 4.3.6. Provide suitable OEM recommended repair equipment/tools required for the satisfactory execution of all repairs made. 4.3.7. Furnish OEM approved lubricants and lubricate wear points within the equipment in accordance with OEM guidelines. 4.3.8. Replacement parts shall be covered by the contractor for the duration of the contract. Extend to the Government all commercial warranties on replacement parts. All replacement parts or supplies utilized will be new parts or OEM refurbished parts. OEM refurbished parts will only be accepted upon written request from the contractor to NMCSD Biomed and will only be utilized/installed upon written approval from NMCSD Biomed to the contractor. 4.4. End-User Requirements: 4.4.1. Service will be performed on all devices included under contract, regardless of the nature of the cause warranting service/maintenance. Contractor shall not refuse any device under this contract submitted for services. At a minimum, Contractor will perform an official inspection of the device and make a determination of the device's reparability, an estimate for the services/parts required, and an official determination of the cause of the issue. 4.4.2. Services shall be unlimited for the devices under the contract for the term of the agreement. There shall be no cap or limit placed upon the number of repairs/replacements on any individual unit, or on the facility. 4.4.3. Contractor will perform preventive maintenance on the "Government-owned Sorin Equipment" at least one (1) time per year, with a minimum of 12 months between preventive maintenance inspections. 4.5. Response Time and Labor: 4.5.1. Contractor will use commercially reasonable efforts to respond by telephone to any report of a malfunction requiring repair within two (2) hours of notification from NMCSD Biomed, Monday through Friday, 0800-1700, Pacific Standard Time. The Contractor will also provide telephone consulting services, twenty-four (24) hours per day, seven (7) days a week. This consulting service will be provided to avoid delays in contract service coverage during after-hours and weekend/holiday periods as applicable. Under no circumstances will the Contractor assume an inquiry, via telephone or any other means, is authorization to provide services not specifically covered by the terms of the contract. 4.5.2. Contractor will use commercially reasonable efforts to provide on-site support within two (2) business days from notification by NMCSD Biomed, unless otherwise noted in Section 4.4. 4.5.3. Work required in the performance of this contract shall be performed between the hours of 0800 and 2000, Pacific Standard Time. All compensation for labor from the hours of 0800 to 2000 Pacific Standard Time is provided for in this contract and included in the contract price. Contractor may be permitted to arrange for the performance outside of these hours via coordination with NMCSD Biomed at no additional-cost-to-the-government. 4.5.4. Any work that would require overtime must be approved, in writing, in advance by the KO. Any work of this nature performed 5. Travel and Related Expenses: Contractor shall be responsible for its service related trip expenses, including round trip travel, mileage, and overnight living expenses. 6. Shipment: The contractor shall not exceed two (2) business days for shipment of all equipment coming from and/or going to NMCSD Biomed minus exceptions or conditions as previously noted in this Statement of Work. All shipping expenses/costs are provided for in this contract and included in the contract price. 7. Liability: 7.1. The contractor shall not be liable for any loss, damage, or delay due to any cause beyond their reasonable control, including but not limited to fire, explosion, theft, flood, riot, civil commotion, war, malicious acts of mischief, or other circumstances outside of human control. 7.2. NMCSD Employees will not perform maintenance or attempt repairs to equipment covered under this contract while such equipment is under the purview of this contract without express, written concurrence from contractor. 7.3. Insurance: Contractor will be required to have liability insurance to cover any actions on the part of the Contractor or their sub-contractors which result in inJury or death to patients, staff, visitors, or other Contractors. Coverage shall be of at least $500,000 per occurrence. Additionally, Contractor is required to have property damage liability insurance of at least $500,000. Liability insurance shall meet the requirements set forth in FAR 28.307-2. 8. Utilities, Facilities, and Equipment Access: 8.1. The contractor may use Government utilities (e.g., electrical power, compressed air, water) that are available and required for any service performed under this contract while at Government facilities. The facilities engineer however must approve of any contractor equipment which would connect to these utilities in order to ensure compatibility with NMCSD utilities. 8.2. Any outages required in order to perform services must be approved by NMCSD Facilities Management prior to initiation of work and shall be performed per Facilities' instruction. Contractor may request Facilities assistance in performing these outages if required. 8.3. Ensure that all use, storage, transport of any materials regulated by OSHA as "hazardous", required for the performance of this contract, is in in compliance with all federal, state, and local regulations. Contractor shall have available MSDS's for any such materials on-site. 8.4. The Contractor will protect all facilities from damage caused by the Contractor and will repair, at no additional cost to the Government, all damages caused by the Contractor's activities. During performance of services, Contractor will keep the site safe, neat, clean and orderly. Contractor will be responsible for all means, methods, techniques, sequences, and procedures of the services 8.S. Access to Equipment: Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start/stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on-duty personnel responsible for such equipment. 9. Security and Safety Requirements: 9.1. The contractor is required to submit/complete Naval Base San Diego RAPIDGate access to NMCSD. Contractor shall contact the RAPIDgate program at 1-877-RAPIDGate or at www.RAPIDGate.com in order to obtain a RAPIDGate pass(es) as necessary in order to perform this contract. All costs for completing RAPIDGate access are the responsibility of the contractor. While awaiting RAPIDGate access, contractor shall, at a minimum, contact NMCSD Biomed not later than 1400 on the day prior to a scheduled visit to submit the required information to complete the NMCSD Temporary Security Pass. In case of emergent repairs or service, the contractor will wait at the NMCSD Main Gate for escort from Biomed personnel. 9.2. Identification, Parking, and Smoking Regulations at NMCSD: Field service personnel shall wear visible photo identification at all times while on the premises of NMCSD. It is the responsibility of the field service personnel to park in the appropriate designated parking areas. Information on parking is available from NMCSD Security personnel. Smoking is prohibited inside any buildings of NMCSD and is restricted to designated smoking locations only. Possession of weapons, alcohol, or pharmaceuticals that are not over the counter and not prescribed to the individual/family is prohibited on the premises. Enclosed containers, including toolkits, are subject to search. Violations of regulations may result in citation answerable in the United States (Federal) District Court. Violation of any policy which results in lost time for Contractor or his sub-contractors is the sole responsibility of the Contractor, and shall not be charged to the government. Contractor employees will demonstrate appropriate behavior and dress at all times. 9.3. Contractor Check-In/Check-Out: Contractor is required to report to Material Management Department, Biomedical Repair Division at Building One (1), Ground Floor, Room GD-18H1 at NMCSD prior to and upon completion of any services or repair work performed. 9.4. General Safety Requirements: The Contractor will exercise safety precautions as the COR or his/her designee may determine to be reasonably necessary to protect the lives and health of occupants of buildings in which work is being performed. NMCSD will notify the Contractor of any non-compliance with the foregoing conditions and the action(s) to be taken. Service vendors will, after receipt of such notice, immediately correct the conditions to which attention has been directed. If field service engineer refuses to comply promptly, the COR may issue an order stopping all or any part of the work. Under such circumstances, the KO and hold the service vendor in contract default. Nothing in this section will be construed so as to limit the Contractor or his sub-contractors responsibilities to comply with any existing law, nor to switch jurisdictions. 9.5. Government Right of Refusal: NMCSD reserves the right to reject any of the contractor's personnel and refuse them permission to enter the premises or work on NMCSD equipment. This right may be exercised at any time. The reasons for rejections may include: lack of training and experience, but may also include but not be limited to: behavior, attire, security concerns, immigration status. 10. Compliance with Applicable Laws: Contractor will be knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of his business. The Contractors personnel will comply with the DoD Information Assurance Policies applicable. Contractors are required to maintain a Drug Free Workplace, as well as to require any sub-contractor to do the same. Contract will require wage determinations and comply with applicable Federal and State worker's compensation and occupational disease statutes. 11. Modifications to Contract: Only the KO has the authority to obligate the government, and then only in writing. No modification or instruction from any party shall be construed to authorize the Contractor to take any action for which they expect compensation without written authorization from the KO. 12. Invoicing: All invoicing shall be done in accordance with this statement of work and in accordance with contract. Failure to do so may delay or interfere with payment for services rendered. 13. NMCSD Points of contact: For all matters concerning performance of this contract, the primary point of contact shall be: Biomedical Repair Division, Material Management Department Building One, Ground Floor, Room GD-18H1 Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134 TEL: 619-532-8010 Fax: 619-532-8013 Email: usn.nmcsd-contractadministrator@mail.mil

For administrative matters, the contractor may contact the contracting officer as designated in blocks 7.a, 7.b, 8, and 9 as found on the Standard Form 1449 issued for the contract, or may contact: Material Management Department Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134 TEL: 619-532-8110 FAX: 619-532-5596 Government Owned Sorin Equipment: Appendix NOMENCLATURE. ECN SERIAL NUMBER HEART-LUNG BYPASS UNIT 133290 48E03935 HEAT EXCHANGER, HEART-LUNG BYPASS 133291 16S15763 PUMP, EXTRACORPOREAL PERFUSION 133292 IOE53539 PUMP, EXTRACORPOREAL PERFUSION 133293 IOE53569 PUMP, EXTRACORPOREAL PERFUSION 133294 IOEl 1181 PHYSIOLOGIC MONITOR MODULE HOUSING 133295 28E44101 CONTROLLER, CARDIOPLEGIA PERFUSION PUMP 133296 60E10849 HEART-LUNG BYPASS UNIT 133306 48E03936 HEAT EXCHANGER, HEART-LUNG BYPASS 133307 16S15758 PHYSIOLOGIC MONITOR MODULE HOUSING 133308 28E44102 PUMP, EXTRACORPOREAL PERFUSION 133309 IOEl 1184 PUMP, EXTRACORPOREAL PERFUSION 133310 IOE53572 PUMP, EXTRACORPOREAL PERFUSION 133311 IOE53589 CONTROLLER, CARDIOPLEGIA PERFUSION PUMP 133312 60E10848 AUTOTRANSFUSION UNIT, BLOOD PROCESSING 133313 B026767I15 ASPIRATOR, SURGICAL 133314 B026233F15 AUTOTRANSFUSION UNIT, BLOOD PROCESSING 133315 B026249F15 ASPIRATOR, SURGICAL 133316 B026212F15 PUMP, EXTRACORPOREAL PERFUSION 134116 50E01456

Soring Group USA is the manufacturer and sole distributer of the needed services. The NAICS code for this requirement is 811219; the small business size standard is $20.5 Million. This notice of intent is not a request for competitive quotes; however, interested persons may identify their interest and capability to respond to this requirement. All information received by 9:15 AM Pacific Time on October 3, 2016 may be considered by the Government. Responses shall be submitted to Jeff Collins at Jeffrey.p.collins20.civ@mail.mil. The email subject line shall state, "Naval Medical Center San Diego, Intent to Award Sole Source to Sorin Group USA." A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.

NO TELEPHONE REQUESTS WILL BE HONORED

Link/URL: https://www.fbo.gov/spg/DON/BUMED/N00259/N0025916N0229/listing.html