RFQ_N00183-15-T-1223.docx

N00183-15-T-1223

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: BioMed Engineering

Vendors quoted price shall be inclusive of all cost including, materials, labor & travel

Payment Monthly, 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 N00183-15-T-1223 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:

1. Past Performance (of ability to repair listed items)

1. Qualification / certification of vendor

1. Qualification / certification of technicians

1. Ability to perform all requested repairs

1. Experience performing requested services. Experience shall be current; min 5 years total experience with a min of 2 years experience in past 3 years.

1. Technical approach to perform required task

1. Price

For Prompt Payment Act Purposes, this contract is:

Subject to the 7-calender day constructive acceptance period

Section B - Supplies or Services and Prices

Maintenance in Accordance with Section C

FFP

for the period 1 Oct 15 - 30 Sep 16 FOB: Destination

MILSTRIP: N0018316RQLC011

PURCHASE REQUEST NUMBER: N0018316RQLC011

NET AMT

0001AA

Maintenance in Accordance with Section C on 1 ea. Cryostat Microtome Model: CM1850 Serial: 991 Manufacturer: Leica Microsystems

ECN: 76693

Location: Histology Lab FOB: Destination

NET AMT

0001AB

Maintenance in Accordance with Section C on 1 ea. Cryostat Microtome Model: CM1850 Serial: 997 Manufacturer: Leica Microsystems

ECN: 76694

Location: Histology Lab FOB: Destination

NET AMT

0001AC

Maintenance in Accordance with Section C on 1 ea. Rotary Microtome Model: RM2255 Serial: 2173 Manufacturer: Leica Microsystems

ECN: 76695

Location: Histology Lab FOB: Destination

NET AMT

0001AD

Maintenance in Accordance with Section C on 1 ea. Rotary Microtome Model: RM2255 Serial: 2174 Manufacturer: Leica Microsystems

ECN: 76696

Location: Histology Lab FOB: Destination

NET AMT

0001AE

Maintenance in Accordance with Section C on 1 ea. Rotary Microtome Model: RM2255 Serial: 2175 Manufacturer: Leica Microsystems

ECN: 76697

Location: Histology Lab FOB: Destination

NET AMT

0001AF

Maintenance in Accordance with Section C on 1 ea. Rotary Microtome Model: RM2255 Serial: 2176 Manufacturer: Leica Microsystems

ECN: 76698

Location: Histology Lab FOB: Destination

NET AMT

0001AG

Maintenance in Accordance with Section C on 1 ea. Rotary Microtome Model: RM2255 Serial: 2177 Manufacturer: Leica Microsystems

ECN: 76699

Location: Histology Lab FOB: Destination

NET AMT

0001AH

Maintenance in Accordance with Section C on 1 ea. Rotary Microtome Model: RM2255 Serial: 3718 Manufacturer: Leica Microsystems

ECN: 106008

Location: Histology Lab FOB: Destination

NET AMT

0001AJ

Maintenance in Accordance with Section C on 1 ea. Rotary Microtome Model: RM2255 Serial: 3719 Manufacturer: Leica Microsystems

ECN: 106009

Location: Histology Lab FOB: Destination

NET AMT

0001AK

Maintenance in Accordance with Section C on 1 ea. Rotary Microtome Model: RM2255 Serial: 3720 Manufacturer: Leica Microsystems

ECN: 106010

Location: Histology Lab FOB: Destination

NET AMT

0001AL

Maintenance in Accordance with Section C on 1 ea. Tissue Processor Model: Peloris Serial: 0260156B Manufacturer: Vision Biosystems Limited

ECN:0018399116

Location: Main Lab FOB: Destination

NET AMT

0001AM

Maintenance in Accordance with Section C on 1 ea. Tissue Processor Model: Peloris Serial: 0260238B Manufacturer: Vision Biosystems Limited

ECN:0018300378

Location: Histology Lab FOB: Destination

NET AMT

0001AN

Maintenance in Accordance with Section C on 1 ea. Slide Printer Model: IPS Serial: 692022006 Manufacturer: Leica Microsystems

ECN:00183066519

Location: Histology Lab FOB: Destination

NET AMT

0001AP

Maintenance in Accordance with Section C on 1 ea. Slide Printer Model: IPS Serial: 882052006 Manufacturer: Leica Microsystems

ECN:0018372905

Location: Histology Lab FOB: Destination

NET AMT

0001AQ

Maintenance in Accordance with Section C on 1 ea. Microscope, Light, Operating Room Model: F40 Serial: 51009001 Manufacturer: Leica Microsystems

ECN:106011

Location: Main Operating Room FOB: Destination

MILSTRIP: N0018316RQSU019

PURCHASE REQUEST NUMBER: N0018316RQSU019

NET AMT

FFP

for the period 1 Oct 16 - 30 Sep 17 FOB: Destination

NET AMT

0002AA

FFP

on 1 ea. Cryostat Microtome Model: CM1850 Serial: 991 Manufacturer: Leica Microsystems

ECN: 76693

Location: Histology Lab

NET AMT

0002AB

FFP

on 1 ea. Cryostat Microtome Model: CM1850 Serial: 997 Manufacturer: Leica Microsystems

ECN: 76694

Location: Histology Lab

NET AMT

0002AC

FFP

on 1 ea. Rotary Microtome Model: RM2255 Serial: 2173 Manufacturer: Leica Microsystems

ECN: 76695

Location: Histology Lab

NET AMT

0002AD

FFP

on 1 ea. Rotary Microtome Model: RM2255 Serial: 2174 Manufacturer: Leica Microsystems

ECN: 76696

Location: Histology Lab

NET AMT

0002AE

FFP

on 1 ea. Rotary Microtome Model: RM2255 Serial: 2175 Manufacturer: Leica Microsystems

ECN: 76697

Location: Histology Lab

NET AMT

0002AF

FFP

on 1 ea. Rotary Microtome Model: RM2255 Serial: 2176 Manufacturer: Leica Microsystems

ECN: 76698

Location: Histology Lab

NET AMT

0002AG

FFP

on 1 ea. Rotary Microtome Model: RM2255 Serial: 2177 Manufacturer: Leica Microsystems

ECN: 76699

Location: Histology Lab

NET AMT

0002AH

FFP

on 1 ea. Rotary Microtome Model: RM2255 Serial: 3718 Manufacturer: Leica Microsystems

ECN: 106008

Location: Histology Lab

NET AMT

0002AJ

FFP

on 1 ea. Rotary Microtome Model: RM2255 Serial: 3719 Manufacturer: Leica Microsystems

ECN: 106009

Location: Histology Lab

NET AMT

0002AK

FFP

on 1 ea. Rotary Microtome Model: RM2255 Serial: 3720 Manufacturer: Leica Microsystems

ECN: 106010

Location: Histology Lab

NET AMT

0002AL

FFP

on 1 ea. Tissue Processor Model: Peloris Serial: 0260156B Manufacturer: Vision Biosystems Limited

ECN:0018399116

Location: Main Lab

NET AMT

0002AM

FFP

on 1 ea. Tissue Processor Model: Peloris Serial: 0260238B Manufacturer: Vision Biosystems Limited

ECN:0018300378

Location: Histology Lab

NET AMT

0002AN

FFP

on 1 ea. Slide Printer Model: IPS Serial: 692022006 Manufacturer: Leica Microsystems

ECN:00183066519

Location: Histology Lab

NET AMT

0002AP

FFP

on 1 ea. Slide Printer Model: IPS Serial: 882052006 Manufacturer: Leica Microsystems

ECN:0018372905

Location: Histology Lab

NET AMT

0002AQ

FFP

on 1 ea. Microscope, Light, Operating Room Model: F40 Serial: 51009001 Manufacturer: Leica Microsystems

ECN:106011

Location: Main Operating Room

PURCHASE REQUEST NUMBER: N0018316RQSU019

NET AMT

Section C - Descriptions and Specifications

MAINTENANCE OF LEICA EQUIPMENT

1. Summary. The following is typical equipment configuration, including operating software to be serviced/maintained under this contract shall include: Service, preventive maintenance, and repairs as may be required for medical equipment manufactured by Leica Microsystems. Standard probes (probes supplies as part of original equipment package) 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

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 (excluding consumables) items and accessories.. This contract shall provide for maintenance services which include on-site corrective repairs, normal working hour coverage (8:00 am to 4:30 pm. Monday through Friday excluding Federal holidays, Christmas Eve and day after Thanksgiving) and routine preventive maintenance services to Department of Defense owned equipment, as listed on the: DD Form 1155 “Order for Supplies or Services”. Where available, vendor is to provide after hours support. Support can be in the form of on-line / electronic, after hours call in or other (service is requested but not required). It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. Vendor will not be required to maintain (if equipted): Cryo-jane tape systems and anti-roll plates.

3.1. Conformance Standards. The contractor shall keep the systems in good operating condition, meeting all equipment and performance requirements published by the original equipment manufacturer. 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 Original Equipment Manufacturer (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 throughout contract period. Contractor and its employees shall maintain qualifications throughout entire contract period. 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 Original Equipment Manufacturer (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 throughout 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 8:00 am to 5:00 pm, excluding federal holidays, Christmas Eve and day after Thanksgiving. 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 / technician / representative must make a best effort to respond with a phone call to the COR or his/her designee within two (2) hour after telephone notification, 24 hours per day. If the problem cannot be corrected by phone, the FSE will make a best effort to commence work (on-site physical response) as soon as possible with a goal of on-site response within 48 hours 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 make a best effort to 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 shall make a best effort to be on-site to service by 9:15 am, Tuesday, August 11th.

3.3.3. Not used

0. 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. Vendor will not be required to respond on Christmas Eve and day after Thanksgiving.

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 will 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 manufacturers (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.

0. Contractor Responsibilities.

a. 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.

3.5.1. All labor, 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 with a goal of 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 hour’s 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.

3.6. 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.

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,) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (example: part number, part value, nomenclature, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended, model and serial numbers, and the name of the FSE performing the service. In the event that agents / sub-contractors 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). The contractor shall attach a Government supplied tag on serviced equipment. As a minimum, the tag shall include; date of service, name of person & company performing service.

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 Manufacturers (OEM) recommendations on a mutually agreed upon schedule between the Government and the selected vendor. Vendor will be required to contact NMCP Biomedical Engineering Dept. as soon as possible after date of award to schedule preventative maintenance inspections, but no less than 2 weeks prior to inspection. 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: (in the event that vendor cannot meet this schedule the vendor is to reschedule maintenance to a mutually accepted time; acceptable both to the Government & vendor) October & April (of each contract year) For CLIN’s AA & AB

c. April (of each contract year) for all remaining items

(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.

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.

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.

0. 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 (where applicable).

3.7.1.7. Inspecting, and replacing where indicated, all mechanical components including, but not limited to;, chains, belts, bearings and tracks, interlocks, clutches, motors, & keyboards (unless identified as consumables or added accessories).

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, and processors. Calibrate or recommend calibration if appropriate.

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

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 manufacturers 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.

3.8. Unscheduled/Corrective Maintenance.

a. Normal Working Hour Maintenance Coverage Maintenance Coverage will be Monday through Friday, between 8:00 am to 4:30 pm. A contractor Service Tech shall make a best effort to respond via telephone within 2 hours after receipt of trouble call, and provide on-site service within 48 hours. Vendor to make a best effort to ensure equipment is operational within 48 hours.

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 (vendor is not responsible for consumables or added accessories)

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. Vendor shall make a best effort to not delay by more than 24 hours waiting for delivery of parts.

3.9. 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. All remanufactured parts must be approved for use by the OEM.

3.9.2. Used parts, those removed from other equipment, shall not be installed without prior approval of the KO or COR

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 Not used

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.

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 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),. 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 Manufacturer, Model Number, and Serial Number.

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

3.15. Not used.

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.

3.20 Additional 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 whichever occurs first. All non-apparent / hidden discrepancies must be identified no later than 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. (vendor is not responsible for consumables)

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 and that they are approved for use by the OEM. 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.

1. 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 90 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. All repairs by replacement must be approved by the Government. The new replaced item must be of equal or greater technological and economic value. The Government shall retain the right to determine “equal or greater”.

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

The contractor 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 current and free of defects such as viruses.

4.5. Service Beyond the Scope of the Contract

a. The Contractor shall make a best effort to immediately, but not later than prior to the performance of work, 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.

N00183-0024 Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information (July 2013)

Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 - "DoD Implementation of Homeland Security Presidential Directive - 12 (HSPD-12)" dated November 26, 2008 (or its subsequent DoD instruction) directs implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives.

APPLICABILITY

This clause applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to a DoN or DoD computer/network/system to perform certain unclassified sensitive duties. This clause also applies to contractor employees who access Privacy Act and Protected Health Information, provide support associated with fiduciary duties, or perform duties that have been identified by DON as National Security Position, as advised by the command security manager. It is the responsibility of the responsible security officer of the command/facility where the work is performed to ensure compliance.

Each contractor employee providing services at a Navy Command under this contract is required to obtain a Department of Defense Common Access Card (DoD CAC). Additionally, depending on the level of computer/network access, the contract employee will require a successful investigation as detailed below.

ACCESS TO FEDERAL FACILITIES

Per HSPD-12 and implementing guidance, all contractor employees working at a federally controlled base, facility or activity under this clause will require a DoD CAC. When access to a base, facility or activity is required contractor employees shall in-process with the Navy Command's Security Manager upon arrival to the Navy Command and shall out-process prior to their departure at the completion of the individual's performance under the contract.

ACCESS TO DOD IT SYSTEMS

In accordance with SECNAV M-5510.30, contractor employees who require access to DoN or DoD networks are categorized as IT-I, IT-II, or IT-III. The IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include Protected Health Information (PHI). All contractor employees under this contract who require access to Privacy Act protected information are therefore categorized no lower than IT-II. IT Levels are determined by the requiring activity's Command Information Assurance Manager. Contractor employees requiring privileged or IT-I level access, (when specified by the terms of the contract) require a Single Scope Background Investigation (SSBI) which is a higher level investigation than the National Agency Check with Law and Credit (NACLC) described below. Due to the privileged system access, a SSBI suitable for High Risk public trusts positions is required. Individuals who have access to system control, monitoring, or administration functions (e.g. system administrator, database administrator) require training and certification to Information Assurance Technical Level 1, and must be trained and certified on the Operating System or Computing Environment they are required to maintain.

Access to sensitive IT systems is contingent upon a favorably adjudicated background investigation. When access to IT systems is required for performance of the contractor employee's duties, such employees shall in-process with the Navy Command's Security Manager and Information Assurance Manager upon arrival to the Navy command and shall out-process prior to their departure at the completion of the individual's performance under the contract. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The decision to authorize access to a government IT system/network is inherently governmental. The contractor supervisor is not authorized to sign the SAAR-Ni therefore, the government employee with knowledge of the system/network access required or the COR shall sign the SAAR-N as the "supervisor".

The SAAR-N shall be forwarded to the Navy Command's Security Manager at least 30 days prior to the individual's start date. Failure to provide the required documentation at least 30 days prior to the individual's start date may result in delaying the individual's start date.

When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor's Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

INTERIM ACCESS

The Navy Command' s Security Manager may authorize issuance of a DoD CAC and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the investigative questionnaire and advance favorable fingerprint results. When the results of the investigation are received and a favorable determination is not made, the contractor employee working on the contract under interim access will be denied access to the computer network and this denial will not relieve the contractor of his/her responsibility to perform.

DENIAL OR TERMINATION OF ACCESS

The potential consequences of any requirement under this clause including denial or termination of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have unclassified access to a federally controlled facility, federally-controlled information system/network and/or to government information, meaning information not authorized for public release.

CONTRACTOR'S SECURITY REPRESENTATIVE

The contractor shall designate an employee to serve as the Contractor's Security Representative. Within three work days after contract award, the contractor shall provide to the requiring activity's Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor's Security Representative. The Contractor's Security Representative shall be the primary point of contact on any security matter. The Contractor's Security Representative shall not be replaced or removed without prior notice to the Contracting Officer and Command Security Manager.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO NATIONAL SECURITY POSITIONS OR PERFORMING SENSITIVE DUTIES Navy security policy requires that all positions be given a sensitivity value based on level of risk factors to ensure appropriate protective measures are applied. Navy recognizes contractor employees under this contract as Non-Critical Sensitive [ADP/IT-II] when the contract scope of work require physical access to a federally controlled base, facility or activity and/or requiring access to a DoD computer/network, to perform unclassified sensitive duties. This designation is also applied to contractor employees who access Privacy Act and Protected Health Information (PHI), provide support associated with fiduciary duties, or perform duties that have been identified by DON as National Security Positions.