N6264517R0036-032417.docx

N6264517R0036

THIS IS NOT A REQUEST FOR PROPOSAL

CLINAC-TRILOGY LINEAR ACCELERATOR MAINT

FFP

BASE YEAR; POP: 5/22/17-5/21/18; PART NUMBER: H291014

FOB: Destination

MILSTRIP: N6264517RCES027

PURCHASE REQUEST NUMBER: N6264517RCES027

ADDITIONAL MARKINGS: ATTN: JESSE LOFTUS; TP3; N00259-7030-E027; N00259-17RM12

NET AMT

CLINAC-TRILOGY SILHOUETTE LINEAR ACCEL

FFP

MAINTENANCE; BASE YEAR; POP: 5/22/17-5/21/18; PART NUMBER: H140971

FOB: Destination

MILSTRIP: N6264517RCES027

ADDITIONAL MARKINGS: ATTN: JESSE LOFTUS; TP3; N00259-7030-E027; N00259-17RM12

NET AMT

FFP

OPTION YEAR 1; POP: 5/22/18-5/21/19

FOB: Destination

NET AMT

FFP

MAINTENANCE; OPTION YEAR 1; POP: 5/22/18-5/21/19; PART NUMBER: H140971

NET AMT

FFP

OPTION YEAR 2; POP: 5/22/19-5/21/20

NET AMT

FFP

MAINTENANCE; OPTION YEAR 2; POP: 5/22/19-5/21/20; PART NUMBER: H140971

NET AMT

FFP

OPTION YEAR 3; POP: 5/22/20-5/21/21

NET AMT

FFP

MAINTENANCE; OPTION YEAR 3; POP: 5/22/20-5/21/21; PART NUMBER: H140971

NET AMT

FFP

OPTION YEAR 4; POP: 5/22/21-5/21/22

NET AMT

FFP

MAINTENANCE; OPTION YEAR 4; POP: 5/22/21-5/21/22; PART NUMBER: H140971

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

ADMINISTRATION INFORMATION

THE POINT OF CONTACT FOR ADMINISTRATIVE CONCERNS FOR THIS ORDER AT NAVAL MEDICAL LOGISTICS COMMAND, 693 NEIMAN STREET, FORT DETRICK, MD 21702 IS KERRY MCKEAN, 301-619-8460, KERRY.A.MCKEAN.CIV@MAIL.MIL.

CONTRACTOR SUPPORT

NOTICE: NAVY USE OF SUPPORT CONTRACTOR FOR CONTRACT CLOSEOUT FUNCTIONS

Naval Medical Logistics Command uses two private contractors in support of the contract closeout process. Those companies are Contracting Resources Group (CRG) of Federal Hill, MD, doing business under the authority of the Small Business Administration’s 8(a) program and the Ability One Program, doing business under the authority of the Javits-Wagner O’Day Act (41 U.S.C.§ 47).

The contract closeout process includes activities such as processing deobligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information you provide to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical proposals and performance information.

Naval Medical Logistics Command has signed Non-Disclosure Agreements with each support contractor employee and has required both contractors to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity.

By acceptance of this contract, the offeror and its subcontractors consent to access of their business sensitive/confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services.

PWS

PERFORMANCE WORK STATEMENT

Linear Accelerator Radiotherapy Systems Hardware and Software Maintenance Naval Medical Center San Diego

1.0. GENERAL INFORMATION

Naval Medical Center San Diego (NMCSD) has a requirement for a non-personal services and maintenance contract for designated Government-owned Varian Linear Accelerator Radiotherapy Systems hardware and associated software.

1.1. Scope. The Contractor shall provide preventive and corrective maintenance services for all equipment listed in Technical Exhibit 1. The Contractor shall maintain the equipment within the original equipment manufacturer’s (OEM) specifications, in accordance with all US, State, and Local law and regulations, US Navy regulations, instructions, and Joint Commission requirements. All Joint Commission requirements are specified in the Comprehensive Accreditation Manual for Hospitals (CAMH), readily available at www.jointcommission.org. U.S. Navy regulations and instructions will be made available upon request. When product recalls or upgrades are necessary to maintain the equipment in service within the original manufacturer’s specifications, the Contractor shall provide all associated hardware and software updates/upgrades.

1.1.1. The Firm, Fixed-Price (FFP) Maintenance shall include unlimited telephone support, regularly scheduled preventive maintenance, inspections, calibrations, corrective maintenance tasks, unlimited emergency responses, and remote support (as allowable, via any existing authorized DISA Business to Business Gateway). Coverage shall be included for all systems listed in Technical Exhibit 1, subsystem components, and assemblies, (i.e. contractor is responsible for total maintenance of entire system). The contractor must maintain the system such that it meets Navy and DHA Cybersecurity requirements. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. The Contractor shall provide all parts, labor, materials, travel, personnel, supervision and freight for the scheduled (preventive) and unscheduled (corrective) maintenance for all equipment identified in Technical Exhibit 1. Maintenance and support shall be provided for a one (1) year period of performance for all equipment listed in Technical Exhibit 1, as referenced in each Contract Line Item Number (CLIN). Four option years shall be available.

1.1.2. The equipment list, in Technical Exhibit 1, shall fluctuate over time, as hardware and software eclipse useful life and as new equipment comes off warranty. However, the aggregate requirement and level of effort will remain relatively constant over the life of the contract. Any fluctuations to the equipment list, in Technical Exhibit 1, will be executed through an official contract modification.

1.1.3. The contractor shall provide telephonic and email technical support during standard business hours (Monday–Friday, 7:30AM–5:00PM, local time).

1.1.4. This contract shall provide unscheduled support/service coverage between the hours of 7:30AM and 5:00PM, local time in San Diego, from Monday through Friday, excluding Federal Government holidays, unless otherwise specified in the equipment listing in Technical Exhibit 2.

1.1.5. Preventive maintenance shall occur outside of the first shift of Radiation Oncology, at a mutually agreed upon time, so as to avoid interruption of clinical workflow and overall patient care. The vendor and COR or Biomedical Equipment Repair Department (BIOMED) Technical Liaison shall agree upon such a time to conduct the four (4) quarterly preventive maintenance service instances. Preventive maintenance shall occur in the months specified in Technical Exhibit 2.

2. DEFINITIONS. As used throughout this work statement, the following terms shall have the meaning set forth below:

2.1. Alternate Contracting Officer’s Representative (ACOR). A Government employee appointed by the KO and responsible in the event the COR is absent due to leave, illness or official business, all the responsibilities and functions assigned to the COR.

2.2. Calibration. This activity should be the procedures for the mechanical adjustments of the device to ensure consistent, standardized performance or output as per the original equipment manufacturer recommendations.

2.3. Contracting Officer (KO). A warranted representative of the federal government who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

2.4. Contracting Officer’s Representative (COR). A Government employee appointed by the KO and responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract.

2.5. Contractor Performance Assessment Reporting System (CPARS). Web enabled application that collects and manages the library of automated CPAR’s.

2.6. Corrective Maintenance: Repair, adjustment, calibration, software manipulation and upgrades or other action taken to return a piece of equipment to original manufacturers specifications following a failure, damage, or other incident that causes the product to no longer perform within the original specifications.

2.7. Defense Medical Logistics Standard Support (DMLSS). The automated procurement, maintenance, and supply system utilized to document various material management functions within the command, and throughout the Department of Defense.

2.8. Field Service Report (FSR). Documentation completed by vendor personnel to officially record all instances of contracted troubleshooting, work, and services conducted on equipment. Specifics on required reporting details can be seen in Section 3.8.2.

2.9. Inspections. The activity of doing functional testing and safety inspections of a medical device at regular intervals to ensure that the equipment is safe for use in accordance with manufacturer’s recommended procedures.

2.10. ISO 9001. The ISO 9000 series is a set of five individual, but related, international standards on quality management and assurance. These standards were developed to effectively document the quality system elements to be implemented in order to maintain an efficient quality system in a company. ISO 9001 is the most comprehensive standard covering design, manufacturing, installation, and servicing systems.

2.11. Medical Treatment Facility (MTF) or Patient Care Facility. All gross square footage for building with a primary function of delivering government health care services. (i.e. hospital or clinic, including all activities providing outpatient and/or inpatient health services for authorized patient care)

2.12. Non-Patient Care Facility. All gross square footage for buildings with a primary focus of non-patient care activities (i.e. storage, warehouse, etc).

2.13. Original Equipment Manufacturer (OEM). The company which has created a specific model of product/device.

2.14. Preventive Maintenance: Preventive maintenance is used to describe those periodic and “as required” services necessary to maintain equipment in an operating condition which minimizes corrective maintenance, including but not limited to calibration, adjustment, lubrication, updating software for security, safety or system functionality issues, as well as that testing required to maintain a safe environment of care which includes electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

2.15. Quality Assurance (QA). Actions, including inspections, performed by the Government to determine whether products and services conform to contract requirements.

2.16. Quality Assurance Evaluator (QAE). A Government employee responsible for performing quality assurance functions for a contracted service.

2.17. Quality Control (QC). Actions, including inspections and preparation of inspection records, performed by the Contractor to ensure that products and services conform to contract requirements.

2.18. Scheduled Parts Replacement (SPR). This is the activity of listing of parts that need replacing at certain intervals. This may be either hour-based or date-based, in accordance with manufacturer’s specifications.

2.19. Uptime: Uptime is defined as that time, during the clinical areas’ normal business hours, when the equipment is available for clinical use without restrictions to the quality of the results, and without safety hazards to the staff or visitors.

3. PERFORMANCE REQUIREMENTS:

The Contractor shall provide equipment maintenance services to include all periodic planned maintenance and unscheduled repairs in accordance with OEM specifications and in compliance with ISO 9001 standards, to include repairs necessitated by operator error. Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel must submit a signed service report to the COR for data entry into DMLSS. The service report shall include all information outlined in sec. 3.8.2 of the contract.

3.1. Service Vendor’s Qualification: The Contractor must be an Original Equipment Manufacturer (OEM) certified service provider. Contractors must verify that an individual whom they plan to employ or continue to employ in the United States is authorized to accept employment in the United States. Individuals, such as those who have been admitted as permanent residents, granted asylum or refugee status, or admitted in work-related nonimmigrant classifications, may have employment authorization as a direct result of their immigration status.

3.1.1. Field Service Personnel shall be authorized by the OEM-certified service vendor to perform the required maintenance services. The Contractor shall ensure that all field engineers possess current OEM-certification level training on all devices encompassed in the equipment list. Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product.

3.1.1.1. Experience of at least three (3) years working on a class of equipment, or over one (1) year on the specific make and model is sufficient to indicate experience. Substantially more time may be required based upon the technology involved. Occasional experience with a limited set of equipment does not meet the requirements of this contract.

3.1.1.2. Service vendors shall provide, to the COR, written assurance of the competency of their personnel as well as a list of credentials of approved field service personnel. The KO and/or COR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

3.1.1.3. Government Right of Refusal: NMCSD reserves the right to reject any of the service vendor’s personnel and refuse them permission to enter the premises or work on NMCSD equipment. This right may be exercised at any time. The reasons for rejections may include: lack of training and experience, but may also include, but not be limited to: behavior, attire, security concerns, and immigration status.

3.1.1.4. Field engineers shall provide all parts, labor, materials, travel, personnel, supervision, and freight necessary to complete repairs and preventive maintenance on all equipment listed within this contract and shall not invoice NMCSD work performed at the direction of the Contractor.

3.1.1.5. Field engineers shall provide services in accordance with the performance requirements specified in this performance work statement.

3.1.2. Technical documentation: The Contractor shall obtain, have on file, and make available to its field service personnel all operational and technical documentation, which is required to meet the performance requirements of this contract. This documentation shall include any software needed or beneficial in speeding the diagnosis, repair, or calibration of the equipment, equivalent to that used by the manufacturer to perform the same work. The Contractor shall ensure that all Field Service Personnel possess the ability to perform corrective software upgrades and manufacture recall notices, and are in possession of legally licensed diagnostic software necessary for rapid, efficient, and effective maintenance.

3.1.3. 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.

3.2. Preventive Maintenance: Contractor must insure that 95% or more of all periodic maintenance is performed within thirty (30) days of due date, and that 100% of periodic maintenance is performed within sixty (60) days of the due date.

3.2.1. Equipment in Use: If, for reasons beyond the Contractor’s control, equipment is not made available for maintenance for the entire thirty (30) days before the maintenance due date and sixty (60) days following the due date, the Contractor shall immediately notify the COR.

3.2.2. Equipment Unable to Locate (UTL). If the Contractor is unable to locate an item within the maintenance window specified, the Contractor shall immediately notify the COR. Contractor shall arrange the performance via coordination with the Contracting Officer’s Representative (COR) or Alternate COR during circumstances of unexpected delays (i.e. non-availability of the patient care areas due to room occupancy, etc.), at no additional cost to the Government. The COR may determine that the property has been disposed of or is otherwise inactive or unavailable for use and adjust Technical Exhibit 1, accordingly.

3.2.3. Preventive Maintenance Scheduling: The Contractor shall schedule service vendor preventive maintenance visits as specified for each equipment item. For each linear accelerator radiotherapy system, the frequency of preventive maintenance will be four (4) times per year. Preventive maintenance visits shall include complete inspection and testing of the equipment in accordance with maintenance procedures identified in DMLSS and/or manufacturer recommended guidelines. Preventive maintenance visits shall be scheduled with NMCSD BIOMED at least one week (40 working hours) in advance. If the routine scheduling for the equipment items is in excess of 1 week in advance, then the preventive maintenance visits must be coordinated at least that far in advance.

3.2.4. 100% Preventive Maintenance: Under the circumstances of 3.3.1 or 3.3.2, the COR and Contractor shall arrange a means of complying with the requirements for preventive maintenance at no additional cost to the Government. Equipment determined missing, lost, or stolen shall be exempt from maintenance.

3.3. Corrective maintenance: The Contractor shall provide for any corrective maintenance services necessary to maintain equipment within the original manufacturer’s specifications, and in accordance with any applicable FDA requirements. Corrective maintenance shall include damage to equipment that results from, but not limited to, unintentional damage, operator error, normal wear and tear, component part failures, environmental issues (e.g., water damage), etc.

3.3.1. Modifications: The Contractor shall maintain equipment within the original manufacturer’s specifications, and shall make no modifications to the original design.

3.3.2. All “repair by exchange” shall be approved in advance.

3.3.3. Response time: Within one (1) hour of notification, contract personnel shall respond by telephone. If the equipment cannot be restored to the operating condition via telephone, the Contractor personnel shall arrive onsite within twenty-four (24) hours. The onsite response time is measured from the time the Contractor is originally called, not from the time the Contractor returns the call. The contractor is expected to return the machine to service within 48 hours from the time the Contractor is initially contacted.

3.3.4. Parts: The Contractor shall provide coverage for all repair and replacement parts necessary to maintain the equipment, listed in Technical Exhibit 1, within the parameters of the original manufacturer’s specifications. Replacement parts shall be furnished within the time specified in Table 1. The contractor shall supply new, non-refurbished OEM parts, including only OEM-approved lubricants and lubricate wear points, for all repairs necessary to restore equipment to the original manufacturer’s specifications, excluding consumables. Replacement parts shall be furnished within the one (1) day of parts ordering. Contractor installed replacement parts shall become the property of the Government. The contractor shall extend to the Government all commercial warranties on replacement parts, consistent with standard industry practices. Replaced items shall be properly disposed of at no additional cost to the Government (contractor shall pay all “environmental fees”, where required). 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.

3.3.5. Software maintenance is included in the scope of the contract, including upgrades and patches as needed.

3.3.6. In the event that a corrective maintenance is started within, but cannot be completed within, standard business hours (7:30AM-5:00PM), the contractor will continue to work until the system(s) is(are) completely repaired and brought back to full operational status. If necessary to initiate services beyond 5:00 PM, local time on weekdays, the COR and NMCSD BIOMED shall be notified prior to performance. No overtime services shall be completed without the prior approval of the COR and/or BIOMED Technical Liaison. Accordingly, no overtime shall be billed to the Government determined to be outside of the scope of this agreement, without prior approval of associated services by the COR and/or KO.

3.4. Training: The Contractor shall provide one (1) initial training session for NMCSD personnel on the procedures and processes of the Contractor’s maintenance program, immediately upon contract award. This training will provide insight into the OEM specified procedures for preventive maintenance and frequently observed issues that require corrective maintenance. When requested by the COR, the Contractor shall provide additional training sessions during the contract period, as required.

3.5. 100 % Completion During Hours of Work: Work required in the performance of this contract shall be performed Monday through Friday, 7:30AM – 5:00PM (local time), excluding Federal Government holidays, unless otherwise specified in the equipment listing in Technical Exhibit 2. Contractor may be permitted to arrange the performance outside of these hours via coordination with the COR, at no additional cost to the Government. The Contractor shall also provide a telephone and email consulting service, spanning 7:30AM – 5:00PM every day (local time). This consulting service shall be provided to avoid undue delays in contract service coverage during after-hours and weekend/holiday periods, as applicable. Under no circumstances shall the Contractor assume an inquiry, via telephone or any other means, is authorization to provide services not specifically covered by the terms of the contract. No overtime shall be billed to the Government.

3.6. Uptime Rate: The Contractor shall maintain an overall uptime rate of 97% or better, for all equipment listed in Technical Exhibit 1.

3.6.1. Uptime Calculation: Uptime is calculated on a rolling six (6) month basis. Until the Contractor has at least six (6) months of performance experience at NMCSD, the uptime shall be calculated cumulatively for the entire duration of the contract. The following formula will be used to calculate uptime:

Basis = Total treatment hours – Scheduled Maintenance (Planned Maintenance) *Note* - Downtime hours must fall within the vendor’s hours of coverage listed in Section 1.1.4. Downtime ends once the system is available for full clinical use.

3.7. Recalls and Updates: The contractor shall provide installation and mandatory updates within 24 hours for Class I equipment recalls and 72 hours for all other classes, upon original manufacturer’s and/or FDA recall or alert notification. The contractor shall provide documentation of such installation and mandatory updates.

3.8. Service Events: Upon arrival on-site, prior to performing any work, field service personnel shall physically sign in with NMCSD BIOMED during normal working hours. The COR, Biomedical Technical Liaison, and/or any Biomed Personnel may accompany the field service person as an observer during any work performed on-site.

3.8.1. Lock Out/Tag Out: The contractor shall personally notify BIOMED, via FSR, of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment (i.e., Lockout, removal to BIOMED) shall be implemented in compliance with Occupational Safety and Health Administration (OSHA) and Navy regulations, specifically Title 29 1910.147 of the Code of Federal Regulations and the OPNAVINST 5100.23G Chapter 24, to prevent any patient, staff, or visitor hazards. Where lockout procedures are not possible, tag-out procedures shall be followed in accordance with the above regulations. Additionally, a label shall be adhered to the disabled equipment specifying the equipment is not serviceable. Reference (i) is available at: http://doni.documentservices.dla.mil/allinstructions.aspx

3.8.2. 95% Service Event Documentation: Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel must submit a signed Field Service Report (FSR) to the Biomedical Equipment Repair. The service report shall indicate all problems addressed, devices checked, parts replaced/repaired, parts ordered, and problem resolution or pending action. Each service report must at a minimum document the following data legibly, in English and in complete detail:

1. Name of contractor

2. Name of contractor personnel performing service

3. Contractor personnel log/control number

4. Equipment identification factors to include: Manufacturer, make, model, serial number and Facility Equipment Control Number (ECN)

5. Description of problem reported by user

6. Date & time of initial trouble call

7. Date & time, beginning and ending, of hours on-site for service call

8. Itemized description of service performed to include, but not be limited to: parts used, problem found, corrective action(s) taken or recommended, communications had with Medical Treatment Facility (MTF) personnel

9. Resolution and/or pending action(s)

10. Estimated total billing cost, if the MTF did not have an existing maintenance agreement:

a. Include the list price of services, labor, travel, and parts

b. Note - This pricing information is not to be confused with an invoice

11. Signatures:

a. Contractor performing service

b. BMET verifying service rendered

3.9. 100% Monthly Reports: The Contractor shall submit monthly management reports on the maintenance and repair activity of all equipment under this contract to the COR via e-mail. This report shall address total preventive and corrective maintenance work orders generated, numbers completed as a percentage, and numbers outstanding at the end of each month. Report of previous month activity should be submitted no later than the fifteenth (15th) day of the following month.

3.10. Test equipment: Test equipment calibration shall be traceable to National Institutes of Standards and Technology (NIST). Any efforts conducted without equipment within the calibration intervals is not performance in accordance with this contract. Upon request by COR, the Contractor and/or service vendors shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on NMCSD equipment.

3.11. Removal of equipment from site: No equipment shall be removed without the approval of the COR and Materials Management Department of the MTF. Property passes for equipment removal shall be obtained by the contractor via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of service contractor personnel are the sole responsibility of the service contractor personnel.

3.11.1. Removal Report: The contractor shall provide a detailed description of removed items in writing on the contractor’s company letterhead. For associated items/accessories, contractor shall provide a detailed written description and quantities of items to be removed. The description will include, as a minimum, manufacturer’s 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.

3.11.2. Off-site repairs: No additional charge shall be allowed for work performed off-site, or any additional time required. 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. The contractor shall provide insurance coverage for damage to or loss of equipment while in contractor or service contractor’s custody.

3.11.3. Hard Disk and Solid State Drives (HDD & SSD): In regards to patient information’s confidentiality and privacy, all contractors and/or service contractors shall not remove equipment containing patient information from the NMCSD. HDD nor SSD shall never be removed from the MTF.

3.11.4. Return of Government-owned property: Upon completion of any and all regularly scheduled preventative or unscheduled corrective maintenance, the contractor shall return all equipment owned by the United States Government.

4. SAFETY REQUIREMENTS: The Contractor shall take safety precautions as the COR may determine to be reasonably necessary to protect the lives and health of occupants of buildings in which work is being performed. NMCSD shall notify the Contractor of any non-compliance with the foregoing conditions and the action(s) to be taken. Service vendors shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. If a field service engineer refuses to comply promptly, the COR may issue an order stopping all or any part of the work. Under such circumstances, the KO can hold the service vendor in contract default. Nothing in this section shall be construed so as to limit the Contractor responsibilities to comply with any existing law, nor to switch jurisdictions.

5. IDENTIFICATION, PARKING, SMOKING REGULATIONS: Field service personnel shall wear visible photo identification at all times while on the premises of NMCSD. It is the responsibility of the field service personnel to park in the appropriate designated parking areas. Information on parking is available from NMCSD Security personnel. Smoking is prohibited inside any buildings of NMCSD. Possession of weapons, alcohol, or pharmaceuticals that are not over the counter or are not prescribed to the individual/family is prohibited on NMCSD premises. Enclosed containers, including tool kits, are subject to search. Violations of NMCSD regulations may result in citation answerable in the United States (Federal) District Court. Violation of any policy which results in lost time for the Contractor is the sole responsibility of the Contractor and shall not be charged to the Government.

6. GENERAL LIABILITY INSURANCE: The Contractor shall be required to have liability insurance to cover any actions on the part of the field engineers which result in injury or death to staff, visitors, or other Contractors. Such comprehensive form of policy shall provide coverage of at least $500,000 per occurrence (FAR 28.307-2).

7. PROPERTY DAMAGE LIABILITY INSURANCE: Service vendors are required to have Property Damage Liability coverage of at least $500,000.

8. MODIFICATIONS TO CONTRACT: Only the KO has the authority to obligate the Government, and then only in writing. No modification or instruction from any party shall be construed to authorize the Contractor to take any action for which they expect compensation without written authorization from the KO.

9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Performance Objective Performance Standard Acceptable Quality Level Monitoring Method/Performance Assessment PWS Reference

100% of all periodic, preventive maintenance is performed within 60 days of due date.

9.1. Compliance with Applicable Laws: Contractor shall be knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of his business.

9.2. Site Visits. The Contractor or his representative having authority to bind the Contractor, shall be required to visit the site at least semi-annually and meet with the KO and/or COR, as required, to discuss and develop mutual understanding relative to safety precautions, labor provisions, and other contractual requirements. This requirement can be cancelled only at the discretion of the KO and/or COR. The Government reserves the right to schedule meetings to discuss or resolve issues/problems, as it deems to be critical, at no additional cost to the Government.

9.3. Work Performed by Others. When work performed by the Government or other Contractors is expected to affect the Contractor’s performance of work, the Government shall coordinate with the Contractor and provide necessary information (plans, specifications, etc.) for such work to the Contractor such that the Contractor may make scheduling allowances. The COR shall resolve any schedule conflicts between the Contractor and work performed by the Government or other Contractors. Such actions shall not result in additional cost to the Government under this contract.

9.4. Government Right to Change Standard Operating Procedures. The Government reserves the right to establish and/or change Standard Operating Procedures which shall be binding on the Contractor, i.e., work order procedures, emergency and fire procedures, security procedures and power failures.

9.5. Phase-In Service: Upon award, which should occur prior to expiration of existing service contracts, the Contractor shall have the opportunity to inspect the existing equipment and note any deficiencies. This action shall occur in sufficient time to notify the existing contract holder to correct deficiencies noted (at least 24 business hours prior to expiration of contract). Failure to submit such list in a timely manner shall be considered acceptance of the equipment in the existing condition. The Contractor shall not be eligible to claim expenses to bring the equipment into manufacturers’ specifications.

9.6. Phase Out of Service: Immediately prior to expiration or termination of this contract (around thirty days), the Contractor, at the Contractors’ expense, shall provide OEM certifications for all equipment covered under contract. If repairs or corrections to the equipment have to be made to obtain such certifications, all shall be made at the Contractors’ expense.

10. GOVERNMENT-FURNISHED PROPERTY AND SERVICES.

10.1. Government Responsibility for Damage. The Government shall not be responsible, in any way, for damage to the Contractor’s stored supplies, material, equipment, or to Contractor’s employees’ personal belongings brought onto the site.

10.2. Physical Security. The Contractor shall safeguard all Government property provided for Contractor use. The Contractor shall designate an individual and alternate(s) to receipt and account for Government-furnished facilities and equipment.

11. CONTRACTOR-FURNISHED ITEMS AND SERVICES.

11.1. Contractor shall furnish all supplies, materials, repair or replacement parts, tools, equipment software upgrading and labor necessary to efficiently and satisfactorily perform the requirements of this contract.

11.2. The Contractor shall protect all facilities from damage caused by the Contractor and shall repair, at no additional cost to the Government, all damages caused by the Contractor’s activities. During performance of services, Contractor shall keep NMCSD safe, neat, clean and orderly. Contractor shall be responsible for all means, methods, techniques, sequences, and procedures of the services. Contractor employees shall demonstrate appropriate behavior and dress at all times.

11.3. Contractor Supplies and Equipment. The Contractor supplies and equipment shall comply with Federal, State, municipal, and industry or OEM specifications.

11.4. Two-way Radios & Cell Phones. The use of Contractor provided two-way radios and cell phones for communication between personnel must be approved by the Base Communications activity and may not be used in designated areas in NMCSD. Contractor shall submit a written request to use the radios to the COR. The request shall detail proposed equipment, operating frequencies, and other particulars in writing. The Government shall not be liable for any damages as a result of not permitting the use of radios within the facility.

11.5. The Contractors personnel shall comply with the DoD Information Assurance Policies applicable.

11.6. Contractors are required to maintain a Drug Free Workplace.

12. PERSONNEL SECURITY.

12.1. Contractor Requirements for Background Checks: It is the contractor’s responsibility to ensure its employees undergo proper criminal history background checks by providing the Government support, cooperation, and active assistance throughout the process.

12.1.1. The contractor shall ensure that employment applications for potential healthcare workers contain a question asking whether the individual has a criminal history, and if so, requiring a description of the disposition of the arrest or charge. The application shall further state that it is being signed under penalty of perjury, with the applicable Federal punishment for perjury stated on the application.

12.2. Government Requirements for Background Checks: The contractor shall comply with DoDD 8500.1, “Information Assurance (IA)”, DoD Instruction (DODI) 8500.2 “Information Assurance (IA) Implementation”, DoDD 5400.11, “DoD Privacy Program”, DoD 6025.18-R, DoD Health Information Privacy Regulation and DoD 5200.2-R, “Personnel Security Program Requirements”. Contractor responsibilities for ensuring personnel security include, but are not limited to meeting the following requirements: Follow the Privacy Office guidelines for submittal of IT security clearances and ensure all contractor personnel are designated as IT-I, IT-II or IT-III where their duties meet the criteria of the position sensitivity designations.

12.2.1. Because of the unique circumstances presented by DoD and DON networks, personnel security requirements shall be followed to ensure appropriate precautions are taken prior to allowing contractor personnel access to the network. Any contractor personnel that will be accessing the medical device/system while installed on the hospital network will be required to have a National Agency Check (NAC) completed. Typically, this requires an investigation to support a “Public Trust Position” and requires the person(s) to complete and submit a Standard Form 85P (SF85P), Questionnaire for Public Trust Positions, via the Electronic Personnel Security Questionnaire (EPSQ). Questions relating to SF85Ps and the EPSQ process may be directed to 1-888-282-7682 or online at http://www.dss.mil/index.htm. Contractor personnel accessing equipment connected to the hospital network will be required to complete a System Authorization Access Request-Navy (SAAR-N) (form OPNAV 5239/14). Copies of this form can be obtained from the Naval Medical Logistics Command (NMLC), or the local MTF. Additionally, contractor personnel are required to complete the annual DoD IA training requirements.

12.2.2. The contractor shall initiate, maintain and document personnel security investigations appropriate to the individual’s responsibilities and required access to Sensitive Information (SI).

12.2.3. Immediately report to the appropriate Navy POC and deny access to any automated information system (AIS), network, or information if a contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate Navy representative for security reasons.

12.2.4. Ensure that all contractor personnel receive DoD IA training before being granted access to DoD AIS’s.

13. CYBERSECURITY

13.1. The contractor shall comply with RMF requirements, as specified by the Defense Health Agency (DHA) that meet appropriate DoD, DHA, and Navy Cybersecurity requirements. The contractor shall initiate the process by providing the required documentation necessary to submit their system to the Authorizing Official (AO) for assessment and authorization (A&A) for all orders delivered against this contract. The requirements shall be met before the contractor's system is authorized to access DoD data or to interconnect with any DoD network or system that receives, processes, stores, displays or transmits DoD data. The contractor shall ensure the proper contractor support staff is available to participate in all phases of the RMF process. This includes, but is not limited to;

13.1.1. Attending and supporting RMF and A&A meetings with Navy and DHA cybersecurity representatives as required.

13.1.2. Support/conduct vulnerability mitigation to comply with cybersecurity controls listed in National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53; Security and Privacy Controls for Federal Information Systems and Organizations and DHA Administrative Instruction 77. In order for a system to be authorized, there shall be zero Category 1 findings.

13.1.3. Support the A&A Team during system security testing.

13.1.4. Once the system has been authorized, the contractor shall maintain an acceptable security baseline consistent with the authorization granted by the AO throughout the life of the system. This includes ensuring that all vulnerabilities affecting the operating system, primary application, database and all third party software have validated and applied within 30 days.

13.2. Cybersecurity: The vendor shall establish appropriate administrative and technical safeguards to protect any and all data, to ensure the confidentiality, integrity, and availability of Government data under their control. At a minimum, this shall include provisions for vendor personnel security and electronic security.

13.2.1. The proposed system shall be capable of supporting the use of Defense Information Systems Agency (DISA) approved antimalware applications. The Navy uses McAfee Host Based Security System (HBSS) as their solution. The vendor shall provide technical specifications that clearly demonstrate whether the proposed solution can integrate and support, either fully or partially the operation without performance degradation of the medical system/device. In cases where the operation of HBSS is not technically achievable, the vendor shall provide detailed justification and a Plan of Actions and Milestones (POA&M) describing steps towards compliance with this requirement.

13.2.2. The vendor must provide their Antivirus (AV) policy and a list of AV Exceptions (if applicable) to the NMLC prior to AV installation on the system/device. AV must be installed on all devices before they are placed on the Navy network.

13.2.3. Systems shall be configured in such a way to allow for the updating of malware definition signatures on a scheduled basis. Scanning shall encompass the entire system (file system, operating system, real-time processes), by default. In cases where scanning of the entire system may negatively affect its operation, the vendor shall provide a detailed list of exclusions with justifications.

13.3. Vulnerability Management: Vulnerability mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating systems, servers, development platforms and the application being delivered to the Navy shall be in compliance with all known applicable guidelines. The vendor shall agree to be proactive in working with the Navy to mitigate new threats as they emerge.

13.3.1. All vendor validated and approved patches, up to and including the date of install, must be loaded on the system prior to system go-live. Security scans will be run during government acceptance testing. All Category I (CAT I) findings must be remediated prior to government acceptance of the system. A CAT I vulnerability is any vulnerability, the exploitation of which will, directly and immediately result in loss of Confidentiality, Availability, or Integrity. There shall be no more than 10 Category II (CAT II) findings at the time of government acceptance. CAT II vulnerabilities are any vulnerability, the exploitation of which has a potential to result in loss of Confidentiality, Availability, or Integrity.

13.4. Domain Name System Realm/Directory Services: Contractor will be required to provide technical evidence, if applicable, whether client/server topology based medical systems can integrate with Directory Services and support LDAP authentication.

13.5. Local Privileged and Administrative User/Local System Accounts: Contractor shall create a single local user account with administrative/root level privileges for purposes of conducting system repairs and maintenance only. This account shall be separate and distinct from the built-in local administrative/root account provided by the Operating System and shall comply with DoD policy. All factors required to complete successful identification, authentication and authorization against the built-in local Administrative/Root level account shall be provided to the MTF Biomedical Engineering Department.

13.5.1. Complete administrative system rights shall be provided to the government System Administrator for the purpose of conducting device vulnerability scans as needed.

13.6. DHA Business to Business (B2B) Gateway: All contractor systems that will communicate with DON systems will interconnect through the established DHA Business to Business (B2B) gateway.

13.6.1. Contractors will connect to the B2B gateway via a contractor procured Internet Service Provider (ISP) connection and assume all responsibilities for establishing and maintaining their connectivity to the B2B gateway. This will include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the DHA VPN device. Maintenance and repair of contractor procured VPN equipment shall be the responsibility of the contractor.

13.6.2. Contractors shall configure their network to support access…