Inactive

This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this is to gain knowledge of potential qualified sources and their size relative to NAICS 811219, Standa... This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this is to gain knowledge of potential qualified sources and their size relative to NAICS 811219, Standard Size $20.5 Million. Responses will be used by the Government to make appropriate acquisition decisions. Responses are not considered responses to any potential solicitation announcement. Scope of Work The Michael E. DeBakey VA Medical Center (MEDVAMC). The contractor shall furnish services required to provide annual preventative maintenance and service on the Abiomed Impell equipment. The contractor shall furnish services required to preventative maintenance and service on the Abiomed Impell equipment. Annual preventative maintenance consists of calibrating the entire instrument to traceable calibration standards. Response to this notice should include a capability statement, and three (3) customer references to which you have provided similar services. All interested firms shall provide the following information: company name, address, point of contact, phone number, email address, capability statement, and business size pursuant to the NAICS Code 811219, Standard Size $20.5 Million. Responses to this notice shall be e-mailed to Jacqueline.Simpson3@va.gov. Telephone responses will not be accepted. Responses must be received in writing no later than Thursday, March 21, 2019 at 10am CST. This notice is to assist the VA in determining sources only. A solicitation is not currently available. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Responses are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. STATEMENT OF WORK Preventative Maintenance Abiomed Impell Equipment OBJECTIVE: Michael E. Debakey Medical Center (MEDVAMC) is requesting for a contractor to provide preventative maintenance and service on the Abiomed equipment at the Michael E. Debakey Medical Center located at 2002 Holcombe Blvd, Houston, TX 77030. The Contractor shall furnish all labor, materials, parts, equipment, license, certification, vehicles, supervision, and other items and services necessary to perform annual preventative maintenance on the Abiomed equipment.  SCOPE: The Contractor shall provide annual calibration and preventive maintenance inspections, beginning on the contract effective date, by authorized Service providers. The calibration procedure will consist of calibrating the entire instrument to traceable calibration standards. The instrument shall be cleaned. Worn or defective parts shall be replaced when necessary, as per manufacturer s specifications. Preventive maintenance inspections shall be scheduled at least three (3) days in advance with the Contracting Officer Representative (COR) or designee. Service also includes all necessary intervening service calls required to replace any worn or defective part needed due to instrument failure. The VA will provide first call service, which includes try to resolve any problem first before calling the Contractor. EQUIPMENT IDENTIFICATION AND COVERAGE  Equipment S/N Asset # Maximo # Additional Terms Abiomed Impell Heart Blood Pump IC6251 1824539 580 MX1824359 Abiomed Impell Heart Blood Pump IC1270 1109566 580 EE14616  Abiomed Impell Heart Blood Pump IC1295 1222032 580 EE143615   Coverage shall include a annual preventive maintenance for each piece of equipment. Coverage shall also include other scheduled and unscheduled maintenance along with all other terms listed within this contract. Quality Assurance: The government shall evaluate the contractor s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is a Government only document primarily focused on what the Government must do to assure that the contractor has performed in accordance with the requirements of the contract. QUALITY CONTROL: Quality Control is the responsibility of the contractor. The Contractor is responsible for the delivery of quality services/supplies to the Government. The Contractor shall develop, implement and maintain an effective Quality Control System which includes a written Quality Control Plan (QCP). The QCP shall implement standardized procedure/methodology for monitoring and documenting contract performance to ensure all contract requirements are met. The Contractors QCP must contain a systematic approach to monitor operations to ensure acceptable services/products are provided to the Government. The QCP, as a minimum, shall address continuous process improvement; procedures for scheduling, conducting and documentation of inspection; discrepancy identification and correction; corrective action procedures to include procedures for addressing Government discovered non-conformances; procedures for root cause analysis to identify the root cause and root cause corrective action to prevent re-occurrence of discrepancies; procedures for trend analysis; procedures for collecting and addressing customer feedback/complaints. The contractor shall upon request provide to the Government their quality control documentation. Contract Administration and Performance Monitoring Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor. The Contracting Officer Representative (COR) and Program Manager (PM) will assist by monitoring contractor performance and reporting the findings to the Contracting Officer (CO). The COR shall be designated on the authority of the CO at the time of contract award to monitor all technical aspects of the contract. In no event is the COR empowered to change any of the terms and conditions of the contract. Changes in any section of this contract shall be made only by the CO pursuant to a properly executed modification. The types of actions within the purview of the COR s authority are to ensure that the Contractor performs the technical requirements of the contract, and to notify both the Contractor and the CO of any deficiencies observed. A memorandum of designation shall be issued to the COR and a copy shall be sent to the Contractor at the time of contract award setting forth in full the responsibilities and limitations of the COR. Performance Measures: a. ACCEPTABLE PERFORMANCE The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action. b. UNACCEPTABLE PERFORMANCE When unacceptable performance occurs, the COR shall inform the Contractor and the CO. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Deficiency Report (CDR) and present it to the Contractor's Point of Contact (POC). The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor must present this corrective action plan to the COR. The Government shall review the Contractor's corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. Inherently Governmental Functions Contractor shall not perform any Inherently Governmental functions in accordance with FAR Part 7.5. Quality Assurance Contractors shall conform to quality assurance standards in accordance with best commercial practices, unless otherwise specified. QASP Preventive Maintenance Number Paragraph in PWS Indicator/Performance Standard Standard for Quality Level Acceptable Quality Level Method of Surveillance Incentive 1 Scope Preventive Maintenance inspections shall be scheduled at least three (3) days in advance to the COR. 100% 100% Observation and random inspection. Positive past performance rating 2 Hours of Coverage Any needed repairs outside the scope of the SOW must be reported to the authorizing VA medical center and the COR within 24 hours. 100% 100% Observation and random inspection. Positive past performance rating 3 Operational Uptime Requirement The Abiomed equipment shall be operable and available for use 97% of the normal operating hours. 100% 100% Observation and random inspection. Positive past performance rating 4 Unscheduled Maintenance (Emergency Repair Service) Contractor's must respond to Emergency calls within two (2) hours. If problem persist after telephone call, it requires contractor on-visit within forty-eight (48) hours after receipt of the second notification. 100% 100% Observation and random inspection. Positive past performance rating 5 Additional Services Contractor shall include, at no extra charge, any engineering and software update necessary for continued optimum operation of the equipment listed in this contract. 100% 100% Observation and random inspection. Positive past performance rating CONFORMANCE STANDARDS Contract service shall ensure that the equipment functions in conformance with the specifications used when the equipment was procured by the VAMC, and any upgrades/updates, as well as following most current published standards/ specifications/regulations:  Manufacturer s specifications, Association for the Advancement of Medical Instrumentation (AAMI), Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), National Fire Protection Agency 99 (NFPA-99), Center for Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic Engineers (IEEE), Underwriters Laboratories (UL), Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract.  Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, UL, OSHA, VA, and CDRH.  The contractor shall supply certification of tuberculosis testing completion prior to commencing any work located on the MEDVAMC campus.  HOURS OF COVERAGE A.  Normal hours of coverage are Monday through Friday from 8:00 a.m. to 9:00 p.m., excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or his designee.  B.  Preventive maintenance will be performed yearly.  C.  Hardware/software update/upgrade installations will be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR). Contractor provides software/hardware upgrade/update.  D.  Work performed outside the normal hours of coverage at the request of COR or designee will be billed at the price listed in Vendor Contract. Billing will include service time plus one (1) hour for travel time, and exclude parts, as they are included in the Vendor Contract. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.  E.  Federal Holidays observed by the VAMC are: New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day UNSCHEDULED MAINTENANCE (Emergency Repair Service) A.  Contractor shall maintain the equipment in accordance with the manufacturer's specifications. The Contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.  B.  The CO, COR or designee has the authority to approve/request a service call from the Contractor.  C.  Response Time: - Contractor's FSE must respond with a phone call to the COR or his/her designee within two (2) hours after receipt of telephoned notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within forty-eight (48) hours after receipt of this second notification and will proceed progressively to completion without undue delay. This requirement for response time shall be the same for both services calls during the VA normal business hours and after-hour service calls. Corrective work shall be completed within forty-eight (48) hours from telephone contact time.  D. Any charges for parts, services, labor, travel, manuals, tools, or software required to successfully complete unscheduled maintenance is included within this contract in the Equipment Identification and Coverage section, and its agreed upon price, unless specifically stated in writing otherwise and approved by the COR.   SCHEDULED MAINTENANCE A.  The Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with Section 3, Conformance Standards. (An outline of the PM procedures and schedule shall be provided to the COR). The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the COR at the completion of the PM. The contractor shall provide written description of Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:  1)  Cleaning of equipment.  2)  Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards or the manufacturer's specifications.  3)  Calibrating and lubricating the equipment.  4)  Performing remedial maintenance of non-emergent nature.  5)  Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.  6)  Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.  7)  Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance.  8)  Returning the equipment to the operating condition defined in Section 3, Conformance Standards.  9)  Providing documentation of services performed.  10)  Inspecting and calibrating the hard copy image device.  B.  PM services shall be performed in accordance with, and during the hours defined in, Section 4, the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.  C.  Any charges for parts, services, labor, travel, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise and approved by the COR. PARTS The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. The contractor shall use new original equipment manufacturer (OEM) parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the COR. (The Contractor shall also list any excluded parts under the service contract).  SERVICE MANUALS/TOOLS/EQUIPMENT/TRAVEL The VAMC shall not provide travel, tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all travel, operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the CO upon request. DOCUMENTATION/REPORTS The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with Section 3, Conformance Standards or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The ESR will consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail: A.  Name of contractor and contract number. B.  Name of FSE who performed services. C.  Contractor service ESR number/log number. D.  Date, time (starting and ending), equipment downtime and hours on-site for service call. E.   VA purchase order numbers covering the call if outside normal working hours. F.   Description of problem reported by COR. G.  Identification of equipment to be serviced:  1)  Inventory ID number,  2) Manufacturer's name, 3) Device name,  4) Model number,  5)  Serial number,  6)  Any other manufacturer's identification numbers. H. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:  1)   Labor and Travel,  2)  Parts (with part numbers),  3)  Materials and Circuit Location of problem/corrective action. I. Total Cost to be billed (if applicable - i.e., part(s) not covered, or service rendered after normal hours of coverage). J. Signatures:  1)  FSE performing services described.  2)  Authorized VA Employee who witnessed service described.  NOTE: - Any additional charges claimed must be approved by the COR before service is completed!  REPORTING REQUIREMENTS The Contractor shall be required to report to Biomedical Engineering 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. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature". If the COR is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).  LIQUIDATED DAMAGES A.  Contractor shall be liable to the Government for losses of production due to significant equipment downtime. Significant equipment downtime is that which exceeds twenty-four (24) hours/month. Records regarding downtime will be kept by the COR and the maintenance contractor.  B.  Equipment downtime is calculated only from those normal hours of coverage (see Hours of Coverage Section) that the scheduled equipment is not fully operational. Downtime will begin when the Contractor is required to be on site (see Unscheduled Maintenance Section response time definition) after notification by the CO, COR or designated alternate. Downtime will accumulate until the scheduled equipment is returned to full and usual operation and accepted as such by the CO, COR or designated alternate. This does not include scheduled maintenance for PM purposes or when waiting for VA furnished tubes. Refusal of access to the equipment indicates that the unit is up and running and this time will not be considered when determining downtime. Refusal of access to the equipment voids the service call.  C.  If downtime exceeds thirty-three (33) consecutive hours, the CO may exercise the option to hire an alternate source to resolve the problem. The decision to exercise this alternative will reside exclusively with the CO. All fees generated by the alternate Contractor(s) will be handled in accordance with Default clause.  D. Monies will be subtracted from the contract if the Contractor fails to meet the up-time requirements using the following formula:  MONTHLY                        MONTHS DOWNTIME 23 - 24 hours/month                       0% 25 - 26 hours/month                        20% 27 - 28 hours/month                        40% 29 - 30 hours/month                        60% 31 - 32 hours/month                        80% 33 or more hours/month               100% These will be computed for the monthly dollar totals. E. Contractor shall be liable to the Government for any damage done to Government property caused by themselves or their employees. CONTACT INFORMATION Upon contract award, the Contractor must provide valid and reliable contact information for service, preventative maintenance, emergency and technical assistance requests. PAYMENT Invoices will be paid in arrears on a quarterly basis. Invoices, MUST INCLUDE, at a minimum, the following information: Contract No., Purchase Order No., Item(s) covered (to include serial #'s) by the PMI and covered period of service. Each invoice must be provided in triplicate. ADDITIONAL CHARGES There will 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 CO and COR (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 the CO and COR with a written estimate of the cost to make necessary repairs. 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. REMOVAL OF EQUIPMENT Should a piece of equipment require repair at the Contractor s plant, the Contractor shall coordinate with the COR the removal of equipment. Government property cannot be removed from the station without a signed Property Pass. This Property Pass may be obtained from Acquisition & Material Management Service, Personal Property Section, 4A-320 after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor s charge. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT A.  Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.  B.  "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 and is OEM Certified. 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, on the Abiomed equipment.  C.   The FSEs shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified", OEM Certified competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC. The CO may authenticate the training requirements, request training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment.  D.  If subcontractor(s) are used, they must be approved by the CO; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval. 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 be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard. SAFETY REQUIREMENTS In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee, may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall have one supervisory employee, who will disseminate requirements to those who work at our facility, report to the Safety Manager s office for a one- (1) time training class before working on-site. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly with such notice, the contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.  The VAMC, CO, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances shall not be held responsible for any safety incident or any injury or any inconvenience experienced by the Contractor, their associates, or subcontractors while performing the services, labor, travel, software upgrades or maintenance included within this contract to the extent applicable by federal, local and state law with federal law taking precedence. INSURANCE A.   Worker compensation and employer's liability: - Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.  B.   General Liability: - Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.  C. Property Damage Liability: - Contractors are required to have Property Damage Liability insurance coverage of at least $500,000. The Vendor will need to access VA systems in order to perform software upgrades, preventative maintenance and maintenance repairs. GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT After the contract has been in force for a period of time, it may be necessary to change and/or modify the operations to provide better service. Pursuant to FAR 43.102, no government personnel other than the Contracting Officer can execute contract modifications on behalf of the government. END OF SERVICE PERIOD No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting Officer. PRIVACY/SECURITY The contractor will not have electronic connectivity to the devices. The Vendor will only have access to patient databases and PHI when physically troubleshooting image quality and other specific imaging related maintenance.  Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO. Electronic or magnetic data storage devices are not to be removed from VA property. OPERATIONAL UPTIME REQUIREMENTS The Abiomed equipment shall be operable and available for use 97% of the normal operating hours of the equipment as detailed in the Hours of Coverage section. The imaging equipment shall be operable and available for use 97% of the normal operating hours of the equipment. Repeated failure to meet this requirement can subject the contractor to DEFAULT action. ADDITIONAL SERVICES Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records. For any service call made during normal working hours, the Contractors repairman shall report their arrival and departure to the COR. Contractor shall include, at no extra charge, any engineering and software update necessary for continued optimum operation of the equipment listed in this contract. Contractor shall include remote monitoring capabilities allowing for remote diagnostics and troubleshooting. The Contractor s repairman shall complete a full-service report, in writing, after each service call (emergency or scheduled) and submit either a hard copy or an electronic version of this report to the COR within 5 days after the service day. PARTS (a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. (b) Contractor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. (c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any ...