14-t-0175.doc

Section A - Solicitation/Contract Form

CLAUSES INCORPORATED BY FULL TEXT

Fill in Blanks:

TIN (tax ID): ________________

CAGE: ________________

DUNS: __________________

Vendor Point of Contact: ______________________Phone: ____________________

Vendor email: ______________________

Naval Medical Center Portsmouth POC: BioMedical Engineering

Vendors quoted price shall be inclusive of all cost including parts, labor and travel

Payment Monthly, Quarterly, Annually (please circle) in Arrears Note: vendor will be required to provide billing electronically via the WAWF Electronic Invoicing method. For additional information, a review of the following web sites may be required: https://wawf.eb.mil http://wawftraining (email) wawf@nmlc.med.navy.mil Vendor to reference N00183-14-T-0175 on all inquires.

Government reserves the right to:

(1) award based on an "All or Nothing Evaluation".

(2) award a “Best Value” requirement. Vendors with superior past performance histories may be given 1st consideration.

Evaluation factors of received quotes will be as follows:

(1) Experience in the maintenance / repair of listed items

(2) Past Performance

(3) Qualifications (to include training / certification in the repair of all items listed)

(4) Ability to obtain proprietary information (to include software updates and service bulletins) and OEM certified replacement parts

(5) Price (price to be used as a deciding factor for equivalent vendors)

PROMPT PAYMENT

For Prompt Payment Act Purposes, this contract is:

Subject to the 7-calender day constructive acceptance period.

“AVAILABILITY OF FUNDS. Pursuant to Section I, Availability of Funds (FAR 52.232-18), of the contract, funds are not presently available for this contract. The Government’s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing to the Contracting Officer.

Section B - Supplies or Services and Prices

Maintenance in Accordance with Section C

FFP

on 1 ea. Brachytherapy System, Remote Afterloading

Model: HDR3

Serial # 14522

Manufacturer: Nucletron

PA # 0018378422

Location: Radiology / Onocology

Note: System has been upgraded to a 18-ch system

FOB: Destination

MILSTRIP: N0018315RQRT002

PURCHASE REQUEST NUMBER: N0018315RQRT002

NET AMT

FFP

on 1 ea. Brachytherapy System, Remote Afterloading

Model: HDR3

Serial # 14522

Manufacturer: Nucletron

PA # 0018378422

Location: Radiology / Onocology

Note: System has been upgraded to a 18-ch system

FOB: Destination

MILSTRIP: N0018315RQRT002

PURCHASE REQUEST NUMBER: N0018315RQRT002

NET AMT

Section C - Descriptions and Specifications

Statement of Work:

DESCRIPTION/SPECIFICATION/WORK STATEMENT

STATEMENT OF WORKPRIVATE

SERVICE/MAINTENANCE OF RADIOGRAPHIC / IMAGING EQUIPMENT

1. Summary. The vendor to provide total maintenance of all equipment identified in Section B. Vendor shall be responsible for all items in a typical equipment configuration, including all interconnections, cabling interfaces, and operating software to be serviced/maintained under this contract shall include: Service, calibration, preventive maintenance, and repairs as may be required for diagnostic radiological medical equipment manufactured by Nucletron. Maintenance, repair and or replacement glassware is to be included in the scope of this contract. Specific models and equipment configurations shall vary by site.

2. Definitions/Acronyms.

2.1. KO - Contracting Officer.

2.2. COR - Contracting Officers Representative. Local technical representative of contracting officer. COR is the main government point of contact for day to day interaction and execution of the services under this contract. Although this specification lists the COR as the primary authority for requesting and approving service, a formal list of authorized persons will be provided at the time of contract award.

2.3. PM/PMI - Preventive maintenance/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 evidence of malfunction or inoperative conditions.

2.4. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on behalf of the contractor on the equipment listed in Section B of this contract.

2.5. NFPA - National Fire Protection Association.

2.6. OSHA - Occupational Health and Safety Administration.

2.7. CDRH - Center for Devices and Radiological Health.

2.8. JCAHO - Joint Commission for the Accreditation of Healthcare Organizations

2.9. FDA – Food and Drug Administration

2.10. OEM – Original Equipment Manufacturer (or assembler) of the original equipment configuration. The OEM is to include the holder of the current patients of covered equipment. (In the case a manufacture has been purchased by another firm or has transferred ownership of product rights to include patients, the Government reserves the right to verify the transfer of these rights prior to acceptance of a firm as the OEM).

2.11. Glassware – X-ray tubes, image intensifier tubes, cathode ray tubes, closed circuit television systems, or any other part of a radiographic imaging system, which actually produces ionizing radiation or a radiographic image.

2.12. Certified Agent of the OEM: A company of firm which has a direct relationship with the Original Equipment Manufacturer (OEM) of subject medical equipment. The nature of this direct relationship must as a minimum provide a guarantee of a vendors performance by the OEM to include but not limited to: (1) Certifying that vendors performance is in compliance with all requirements and specifications as detailed by the OEM (2) Certification by the OEM that all vendor employees have current certification of training for the maintenance and repair of equipment covered by this award. (3) Certification by the OEM that all supplied repair parts are certified / approved for use for equipment covered by this award. (4) The selected vendor must be under the guidance of the OEM at all times during this contract award period. The OEM as a minimum must have a formal audit program of vendors work. The selected vendor must have the ability to provide the Government with permission to review the vendor’s performance results under the OEM audit program. Performance reviews must be available to the Government within 10 business days of request.

2.13. Current (Current Training / Current Certification): Within 2 years of contract award or within 2 years of request for compliance.

2.14. Certified Replacement Parts: Replacement parts and or equipment which has been certified and approved for use by the OEM. Replacement parts must maintain the integrity of system / equipment certification to include compliance with any UL, AMA, JACHO, Manufactures Certifications or any other certifications as they apply.

2.15. Certified OEM Technician: A journeyman level; Biomedical Equipment Repair Technician which has attended and satisfactorily completed training from the OEM of the equipment being serviced. Or attended and satisfactorily completed training from a facility which has been approved by the OEM. Certification training shall be specific to the equipment being serviced.

3. FULL MAINTENANCE SERVICE

Selected vendor must be able to provide full contract support immediately upon award of a resulting order. Vendor will provide full maintenance support for the items listed in Section B and all support items / components. As a minimum vendor shall provide for maintenance services which include on-site corrective repairs, normal working hour coverage (7:00 am to 4:30 pm. Monday through Friday excluding Federal holidays) and 24-hour / 7-day a week offsite / telephone support emergency service and routine preventive maintenance services to Department of Defense owned equipment, as listed on the: DD Form 1155 “Order for Supplies or Services”. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). Offsite 24/7 support as a minimum must include contact with a “live” service technician knowledgeable in the maintenance and repair of all covered equipment. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated.

3.1. Conformance Standards. The contractor shall keep the systems in good operating condition, meeting all current equipment and performance requirements published by the original equipment manufacturer. Contractor must have direct access to current OEM publications and technical data including data detailing maintenance / operation oddities (IE: OEM Equipment History Data Base and Predatory Software Keys). The contractor also assumes responsibility for system conformance with the latest published edition of NFPA-99, OSHA, FDA, and CDRH.

3.2. General

a. The Contractor shall comply with Federal, State, and Local Laws, plus any Federal Regulations as applicable to the performance of this contract.

b. The Contractor shall not accept any instructions issued by any person employed by the U. S. Government, other than: the Contracting Officer (KO), or Biomedical Engineering Division (BME), all acting within the limits of their authority.

c. The Contractor shall be qualified / authorized by the OEM (IE: Certified Agent of the OEM) in the repair of all equipment listed within this contract. Certification of the OEM must be current (within 2 years) at all times prior to contract award and through out contract period. Contractor and its employees shall maintain qualifications throughout entire contract period. In the event that a sub-contractor is used for this requirement, the sub-contractor must be a Certified Agent of the OEM. Qualification includes but not limited to the certification of all repair persons and repair facilities by the OEM as being trained / qualified to perform required repairs. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance. Additionally contractor must have ready access to parts inventory of OEM replacement parts. All replacement parts must be authorized / certified for use by the OEM.

d. All Contractor employees must be qualified / authorized by the OEM (Certified OEM Technician) in the repair of all equipment listed within this contract. Certification of the OEM must be current (within 2 years) at all times prior to contract award and through out contract period. Performance of maintenance or repair by persons that do not hold current OEM qualifications will not be allowed. Qualification includes but not limited to the certification of all repair persons / technicians and by the OEM (or OEM approved facility) as being trained / qualified to perform required repairs.

3.3. Hours of Coverage.

3.3.1. Normal hours of coverage are Monday through Friday from 7:00 am to 4:30 pm, excluding federal holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by the COR.

3.3.2. Response Time: Contractor’s FSE must respond with a phone call to the COR or his/her designee within one (1) hour after telephone notification, 24 hours per day 7 days a week. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) no later than the close of business (4:30 pm) on the next business day after contractors’ initial receipt of notification and will proceed progressively to completion without undue delay. For example, if a call is placed during coverage hours and no sufficient prescribed coverage hours are remaining in the day, the FSE should be on site at the beginning of the next coverage day. e.g. if hours of coverage are 7:00 am to 4:30 pm, with a four (4) hour response time, and a call is placed at 2:45 pm, Monday, August 10th, the FSE must be on-site to service by 7:00 am, Tuesday, August 11th.

3.3.3. Not used

3.3.4. Federal holidays observed by the DoD include New Years Day, Martin Luther King Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day and Christmas Day.

3.4. Scope of Work

a. The Contractor shall provide trained, experienced, English speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance.

b. The Contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator must be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet the original equipment manufacturer’s (OEM’s) specifications.

d. Equipment and associated components shall be serviced as listed on: DD Form 1155, “Order for Supplies or Services”.

e. The Contractor Point of Contact (POC). The Contractor shall provide in writing the name and telephone number of a primary and alternate English-speaking individual to act as their representative for the scheduling and coordination of service calls, and to be responsible for the coordination of the contract with the Government.

f. The Contractor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Contractor or his representatives. All such replacement or repair shall be at the Contractor’s expense and shall be inspected to the satisfaction of the KO or appointed representative.

3.5 Contractor Responsibilities.

The Contractor shall provide total maintenance of all items identified in this order to include total maintenance of x-ray tubes / “glassware”.

3.5.1. All labor, including installation and calibration of contractor furnished x-ray tubes, all service, materials, transportation, travel time, and replacement parts shall be included to maintain the Covered Medical Systems and ancillary equipment listed herein to the required uptime.

3.5.2. Point of contact. The contractor shall provide a single point of contact to the KO for any maintenance service required under this contract. This information shall include name, title, address, and telephone number.

3.5.3. Maintenance Service Support. The contractor shall furnish maintenance service support to include corrective and preventive maintenance for the system to ensure a minimum uptime of 98%.

3.5.3.1. Operational Uptime. Operational uptime is defined as the state when the system is working according to the performance specifications of the original equipment manufacturer and available for use 24 hrs a day, 7 days a week,. Percentage uptime is calculated as total hours uptime in hours divided by the sum of total uptime and downtime in hours.

3.5.3.2. Downtime. Downtime is defined as the state when the system is not operable or available for routine clinical use (during coverage time). The start of a downtime will be the time the contractor is notified by the designated government representative.

3.5.3.3. Scheduled routine preventive maintenance shall not be considered in downtime calculation.

3.5.3.4. Minor system failures of ancillary components which do not affect system clinical use and availability will not be considered in down-time calculation, except if the FSE needs to preempt use of the system to accomplish the repair. Downtime will then start once the FSE makes the equipment unavailable for use. Corrective service for these system failures is however, subject to the remainder of the provisions of this specification.

3.5.3.5. Telephone Assistance. The contractor shall provide telephone assistance 24 hours per day for equipment covered under this contract. Telephone assistance shall be toll free to the government. The COR or designated representative shall be able to call and receive assistance in correcting problems with equipment operation or the contractor will have the ability to dial directly into the equipment and remotely assess or repair the problem with the equipment.

3.5.3.6. Updates. The contractor is responsible for providing and installing manufacturer designed and issued field modifications, safety corrections and revisions for correcting software and equipment deficiencies at no additional cost to the Government.

3.5.3.7. All replaced items shall be calibrated as required upon installation and before equipment is certified for use.

3.5.3.8. All maintenance and repair requirements of this order including initial inspection of equipment for service must be performed by a Certified OEM Technician

3.6. Contractor Report Requirements.

a. During normal duty hours, Contracted Field Service Engineer (FSE) personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. (Biomedical Engineering located in Build-250 1st floor; 757-953-5336). The Contractor FSEs shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, Contractor FSE’s shall notify the Officer of the Day Desk (Bldg 2, 2nd Floor) and the systems operator designated by BME. All equipment not fully operational after service / repair shall be “tagged” with a operation warning tag to identify, Caution, Danger or Do Not Use condition of equipment. Each tag shall include: name and phone number of person applying tag, date, instructions for use / non-use.

b. The Contractor shall provide to BME a full service report within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, equipment description (model, serial number, equipment control number) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended and the hourly rate normally charged for the type of service performed, model and serial numbers, and the name of the FSE performing the service. In the event that agents / sub-contractor’s are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. Tag may either be a “sticker” or “hanging tag”. As a minimum the tag shall contain: the name of the contractor, technician performing inspection and date of inspection legibly printed.

3.7. Preventive Maintenance/Calibration

a. In accordance with Naval Medical Logistics Command (NAVMEDLOGCOM) Risk Assessment Criteria, preventive maintenance shall be performed in accordance with the Original Equipment Manufactures (OEM) recommendations on a mutually agreed upon schedule between the Government and the selected vendor. All equipment as a minimum will require 1 annual preventative maintenance inspection. Vendor will be required to contact NMCP BioMedical Engineering Dept within 30 days of award to schedule preventative maintenance inspections. As a minimum all equipment will require an annual inspection. Where applicable, vendor is to perform any required calibration of equipment during preventative maintenance inspection. The results of calibration shall be included within the field service report for the maintenance inspection.

b. The Government shall select the months in which preventive maintenance services are to be performed. The preventive maintenance visits shall be performed during the following months: A total of 4 maintenance inspections are required. Inspections, shall be conducted on a quarterly basis schedule on a mutually agreed upon schedule between the vendor and Government. All inspections must be performed in a manner to ensure that the integrity of all equipment sources are maintained at a level acceptable for satisfactory performance of the covered system.

(The Government Fiscal Year runs: October through September). The Contractor shall schedule and complete preventive maintenance services prior to the 15th of the selected month. Services to be performed per a mutually agreed schedule between the Government and vendor.

c. All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required.

d. The contractor on a quarterly schedule shall provide a radiation source change out. The contractor shall properly dispose of all removed equipment. At a minimum of 7-days in advance of work, contractor is to schedule work to include the movement of any radioactive source with the NMCP radiation safety officer. Upon completion of work contractor is to test system (where applicable) per manufactures, NRC (Nuclear Regulatory Agency) and industry standers as they apply. Contractor and contractor employees must comply with NRC rules / guidelines as they apply.

3.7.1. The contractor shall perform PM service to ensure that the equipment listed under this contract performs in accordance with Conformance Standards. The contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) and provide them to the COR or his designated representative at the completion of the PM. The contractor shall schedule PM services with the COR at least 48 hours prior to conducting the services. PM services shall, at minimum, include the system services at the frequencies recommended by the original equipment manufacturer. These services must include, but need not be limited to:

3.7.1.1. Cleaning of equipment.

3.7.1.2. Calibrating and lubricating the equipment.

3.7.1.3. Performing remedial maintenance of a non-emergency nature.

3.7.1.4 Testing and replacing faulty and worn parts and/or parts which are likely to become faulty, fail, or become worn before the next PM, except glassware.

3.7.1.5. Inspecting for wear and fraying, and replacing where necessary, electrical wiring, cables, high Voltage cables, bushings and dielectric as necessary.

3.7.1.6. Measuring, adjusting and calibrating as necessary for optimal image quality.

3.7.1.7. Inspecting, and replacing where indicated, all mechanical components including, but 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.

3.7.1.8. Returning the equipment to the operating condition defined in the OEM’s Conformance Standards.

3.7.1.9. Providing documentation of services performed.

3.7.1.10. Inspecting output devices, e.g. monitors, laser imagers, cameras and processors. Calibrate or recommend calibration if appropriate.

3.7.1.11. Consult with the equipment operator(s) regarding equipment performance.

3.7.1.12 Inspect all sources (to include calibration sources) associated with Gamma Camera’s. Contractor shall repair / replace and source that is defective to include sources which have lost strength due to “half life” age.

3.7.2. All exceptions to the PM schedule must be arranged and approved in advance with the COR.

3.7.3. Any charges for parts, services, manuals, tools, instrumentation, or software required to successfully complete scheduled PM are included within the price of each CLIN.

3.7.4. Calibration of the system shall be scheduled and performed in accordance with the original equipment manufacturer's recommended schedule unless required more frequently because of a remedial service call which required a major component change such as a tube replacement. The contractor shall complete and affix the Medical Equipment Verification-Certification Label (DD Form 2164) to each system or subsystem upon completion of the scheduled service inspection (PMI or Calibration). All forms needed by the contractor will be furnished by the COR prior to the first scheduled service inspection.

3.7.5. The contractor shall furnish documentation, including photographs, radiation dose measurements, and all applicable x-ray film exposures, of all measurements and calibration to ensure that the system is performing in accordance with FDA/CDRH regulations, as applicable, based upon the date of system manufacture or remanufacture.

3.7.6 The contractor shall furnish all backup documentation, including photographs and all applicable x-ray film exposures of all measurements and calibrations, to ensure that the system is performing in accordance with the Conformance Standards listed Section C.3.1. As a minimum, the following specific system operation parameters shall be surveyed and documentation provided to the COR during the eleventh (11th) month of each subsequent option period:

3.8. Unscheduled/Corrective Maintenance.

a. Normal Working Hour Maintenance Coverage

Maintenance Coverage will be Monday through Friday, between 7:00 am to 4:30 pm. A contractor Service Tech shall respond via telephone within 1 hours after receipt of trouble call, and provide on-site service no later than the close of business (4:30 pm) on the next business day. Equipment shall be operational within 48 hours. The Government reserves the right to deduct from the Contractor’s payment an amount not to exceed the hourly rate of $50.00 per hour for each hour the Contractor fails to respond, as specified in the contract.

a. In the event that emergency service outside the normal working hours are required by the Government, additional work shall be billable to the Government at published commercial rates, and negotiated and approved by a Contracting Officer prior to services rendered. . Parts and special shipping that may be needed for equipment worked on outside of normal hours shall be included in the price of the appropriate CLIN for each piece of equipment. If work is performed outside coverage hours, without the proper request / authorization from the Contracting Officer, the work will be considered as service during normal coverage hours.

b. Government request for corrective maintenance will be placed by BME, to the Contractor’s POC. Corrective Maintenance shall be completed during the hours specified in the contract.

c. The Contractor shall assign a unique Log/Reference Number to each Government request for corrective Maintenance.

d. Contractor’s response to requests for service may include telephone consultation with the equipment user/operator and a Contractor FSE. Telephone consultation shall: 1) provide instruction in determining operator error; 2) to determine the most likely cause of the problem; 3) to determine if resolution of the problem requires the dispatch of a FSE; and 4) to identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

e. Contractor’s pricing shall be inclusive of all cost including parts, labor, travel and shipping, unless otherwise indicated. Any/all exclusions are listed as follows:

No Exclusions

3.8.1. Contractor shall respond to all intervening service calls necessary between scheduled PM's and calibrations.

3.8.2. All required parts (including shipping) and service shall be furnished as part of this contract without additional cost to the government.

3.8.3. The KO, COR, or designee alternate has the authority to place a service call with the contractor. A complete list of authorized personnel will be furnished at the time of contract award.

3.8.4. Maintenance actions. Once a maintenance action is initiated, it shall be continuous until the task is complete. Compliance shall be manifest by continuous presence of the FSE(s) on the job site, unless waiting for delivery of replacement parts. Under no circumstances however, shall maintenance actions be delayed by more than 24 hours waiting for delivery of parts.

3.6. Parts. The contractor shall be able to furnish and replace parts to meet uptime requirements. The following requirements apply to parts provided under this contract.

3.9.1. All parts used for service of this system shall be new or remanufactured. If remanufactured parts are used, maintenance records must indicate date of refurbishment or remanufacture and the name and location of the company that provided the part. For CT and MRI systems, only new or OEM remanufactured parts shall be used.

3.9.2. Used parts, those removed from other equipment, shall not be installed without prior approval of the KO or COR in consultation with the command’s Chief Medical Physicist.

3.9.3 All replacement parts must be OEMCertified Replacement Parts: Replacement parts and or equipment which has been certified and approved for use by the OEM. Replacement parts must maintain the integrity of system / equipment certification to include compliance with any UL, AMA, JACHO, Manufactures Certifications or any other certifications as they apply.

3.10 Equipment Modifications

a. The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from BME prior to the Contractor installation of any modification, alteration, or upgrades.

b. The Contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these modifications in accordance with the time schedule set forth by the OEM.

c. The Government shall not alter the system without prior notification to the Contractor.

d. The contractor at no additional cost shall provide software updates to the Government. Installation of updates will be left to the discretion of the Government. All supplied software is to be warranted free of defects, including viruses.

f. The Contractor shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract.

3.11. X-ray Tubes.

3.11.1 If the requirement for a replacement x-ray tube exists, it will be provided by the Contractor under the appropriate line item number of this contract. The replacement of an x-ray tube shall include, de-installation of the faulty tube, reinstallation and recalibration of the replacement x-ray tube. Tube replacement must be accomplished within eight (8) hours.

3.11.2. The replacement of x-ray tubes, regardless of the purchase source, shall be included in the cost of this contract. The contractor is responsible for completing and submitting all applicable reports to the FDA and the COR.

3.11.3. X-ray tubes provided under this contract must meet or exceed the performance specifications of the x-ray tube recommended by the original equipment manufacturer.

3.11.4. Contractor must provide any modifications required installing or operating the tube (mounting brackets, trunions, or calibration proms). Any modifications made must not be permanent and must allow installation of OEM tube at a later date.

3.12. Special Tools, Diagnostic Software, Test Equipment and Technical Documentation.

3.12.1. The contractor shall have all special handling equipment for complete servicing of the systems covered, including the replacement of x-ray tube heads and MRI coils, and ramping MRI systems up and down.

3.12.2. The government will not provide service manuals or service diagnostic software to the contractor. The contractor will be responsible for providing all service manuals, operational manuals, schematics, and diagnostic software to the FSE(s) necessary to maintain the required system uptime.

3.13. Documentation and Reports. The contractor shall furnish a signed System Maintenance Record to the COR or his designee at the completion of each PMI or corrective service call. The COR or his designee will countersign the report to certify that the services were rendered. The government will not recognize any maintenance actions that have not been signed by the designated government representative. All maintenance documents will be prepared and validated in duplicate. One (1) copy will remain with the imaging system and one (1) copy shall be provided to the COR or his designee. Documentation and reporting shall be in compliance with JCAHO and FDA standards.

3.14.1. The System Maintenance Record for each PMI or service call will include at minimum:

3.14.1.1. Name of the contractor.

3.14.1.2. Name the servicing FSE.

3.14.1.3. Date, Time (starting and ending), Equipment Downtime, and Hours On Site.

The FSE must report to the Medical Equipment Repair Shop in accordance with local guidelines.

3.14.1.4. Description of the problem reported by the COR/User and an itemized description of Service Performed (including labor, parts, and corrective action taken).

3.14.1.5. Identification of Equipment to include Index Number, Manufacturer, Device, Model Number, and Serial Number.

3.14.1.6. Contractor must complete DD Form 2164 when accomplishing PMI and/or calibration.

3.15. Assessment for Failure to Maintain 98% Uptime Requirements.

3.15.1. Contract payments for the base period cost invoiced at the end of the quarter in which the contract expires.

3.15.2. Failure to meet the reliability standards of 98% uptime during any month will result in a corresponding percentage reduction in that quarter's payment, calculated as follows:

Hm = Minimum number available hours/quarter allowed

(98% of total)

Ha = Actual hours available

Pt = Total payment invoiced for the quarter

%Assessment = (1 - Ha/Hm) * 100%

Payment Reduction = Pt * %Assessment

3.16 Condition of Existing Equipment. Failure to inspect the equipment prior to award of the contract will not relieve the contractor from performance of the requirements of this contract. The contractor accepts responsibility for the equipment in "as is" condition at time of award.

3.17. Contractor Service Personnel

3.17.1Contractor service personnel (FSEs) shall be English speaking and be required to provide documentation of current professional formal factory training on the equipment to be serviced and annual continuing education, per JCAHO section PL.3.2.1.2. The FSEs provided under this contract shall have at least an Associate’s degree or equivalent training in Biomedical or Electrical Engineering.

3.17.2. The COR may at any time request verification of service personnel credentials who are servicing the equipment.

3.17.3. If subcontractor(s) are used, the KO must approve them; contractor must submit any proposed changes in the subcontractor(s) to the KO for approval/disapproval.

3.18. Claims of Government Misuse or Abuse. If the contractor claims any service calls are the result of government abuse or misuse, the damage must immediately be shown on the System Maintenance Record and verified by the COR and approved by the KO before repairs are made. The KO will resolve disagreements as to responsibility.

3.19. Reporting Required Services beyond the Contract Scope. The contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the KO 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 KO and COR with a written estimate of the cost to make necessary repairs, and a full technical description.

3.20Additional Charges. There will be no additional charge for time spent at the site awaiting the arrival of additional FSE(s) and/or delivery of parts.

4. Government furnished property, Materials and Services.

a. The Contractor representative(s) at each site is encouraged to request a pre-maintenance inspection prior to the onset of the contract. As all apparent discrepancies must be identified upon submittal of quote, any and all claims must be received within 30 days of contract award or prior to contract start which ever occurs first. All non-apparent / hidden discrepancies, must be identified no later that the first scheduled preventative maintenance. Any claims resulting from hidden defects must be received within 30 days of first scheduled preventative maintenance. Any equipment found to be inoperable during this pre-maintenance inspection would be repaired using a separate purchase order. The cost of repairs shall not exceed contractor’s normal retail rate for required repairs. The government certifies that the equipment to be maintained under this contract will be in good operating condition on the effective date of this contract. For the purpose of this contract, the clause, “good operating condition” means the conditions necessary for the equipment to function as intended without corrective maintenance. The Contractor agrees to leave the equipment in good operating condition at the expiration of this contract. During the final week of this contract, the Government will make final inspection of the equipment. Any correction of deficiencies noted during this inspection shall be resolved prior to contract end. The Government reserves the right to request the repair (at no additional cost to the Government) of items identified with latten defects after contract termination, when it has been determined that defects either are a result of contractor’s performance or should have been discovered during normal performance of work under this contract.

b. The government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM.

c. The Government will operate the system in accordance with the instruction manual provided by the OEM.

d. The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials, or for the personal belongings brought onto Government property by Contractor’s personnel.

4. 1 Contractor Furnished Property and Material.

a. The Contractor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the contractor service technicians and as required for the completion of the services in accordance with this contract.

4.2. Replacement Parts.

a. The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacements parts are required to be shipped. Shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government.

b. The Contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the Contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all “environmental fees” where required).

d. Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the Contractor.

e. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall specifically annotate on the final Field Service report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality.

f. The Contractor must include software revisions and updates (field service changes), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of Preventative Maintenance Schedules.

4.3. Removal of Government Property

a. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify BME who will make arrangements for the Contractor to remove the item to the Contractor’s designated site. The Contractor may be required to sign a Government form accepting responsibility for the Government equipment. The Contractor shall provide a detailed description of removed items. For associated items / accessories, contractor to provide a detailed description and quantities of items to be removed. Description to include as a minimum manufacturers serial numbers and equipment control number (ECN) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement” a detailed description of replaced items is to be included upon return of repaired components.

b. All charges resulting from a Contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Contractor.

4.4. Equipment Modification Upgrades

provide software updates to the Government. Installation of updates will be left to the discretion of the Government. All supplied software is to be warranted current and free of defects such as viruses.

4.5. Service Beyond the Scope of the Contract

a. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify BME, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which the Contractor considers they are not responsible for under the terms of this contract.

b. At the same time of the notification, the Contractor shall furnish BME with written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

Section F - Deliveries or Performance

DELIVERY INFORMATION

30-SEP-2015

RADIOLOGY DEPARTMENT

620 JOHN PAUL JONES CIRCLE

BLDG 249

PORTSMOUTH VA 23708-2197

757-953-5486/5471

FOB: Destination N00183

30-SEP-2016

FOB: Destination N00183

CLAUSES INCORPORATED BY REFERENCE

Section G - Contract Administration Data

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through

WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

(Contracting Officer: Insert applicable document type(s). Note: If a “Combo” document type is identified but not supportable by the Contractor's business systems, an “Invoice” (stand-alone) and

“Receiving Report” (stand-alone) document type may be used instead.)

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

(Contracting Officer: Insert inspection and acceptance locations or “Not applicable”.)

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF

Data to be entered in WAWF

Pay Official DoDAAC

Issue By DoDAAC

Admin DoDAAC

Inspect By DoDAAC

Ship To Code

Ship From Code

Mark For Code

Service Approver (DoDAAC)

Service Acceptor (DoDAAC)

Accept at Other DoDAAC

LPO DoDAAC

DCAA Auditor DoDAAC

Other DoDAAC(s)

(*Contracting Officer: Insert applicable DoDAAC information or “See schedule” if multiple ship to/acceptance locations apply, or “Not applicable.”)

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

(Contracting Officer: Insert applicable email addresses or “Not applicable.”)

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

(Contracting Officer: Insert applicable information or “Not applicable.”)

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause)

Section H - Special Contract Requirements

CLAUSES INCORPORATED BY FULL TEXT

N00183-0002 Authorized Callers (Medical) Only persons authorized by the Division Officer or his designated representative from Materiel Management department located in/at the Biomedical Engineering Division, Naval Medical Center, Portsmouth, VA, telephone (757) 953-5764, are to place trouble or repair calls against this maintenance agreement. Calls placed by unauthorized personnel may result in non-payment of services. In each instance that the contractor or his agent reports to Biomedical Engineering Division, Naval Medical Center, Portsmouth, VA, in response to the terms of this order, he shall log in an out with the Biomedical Engineering Division. When inspections and/or repairs have been completed, the contractor or his agent shall obtain the signature of the Department Head or his representative as applicable, on a detailed service ticket and shall leave the customer copy of the service ticket when checking out with the Biomedical Engineering Division. A copy of the service ticket shall be submitted with invoice for payment. In case of inquiries, call Biomedical Engineering Division, Naval Medical Center, telephone (757) 953-5764.

N00183-0004 PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION

1. Introduction In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Business Associate meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Business Associate agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented.

a. Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition…