7 - PERFORMANCE WORK STATEMENT.docx

Performance Work Statement: Medical Device Maintenance & Service NMC Portsmouth

PERFORMANCE WORK STATEMENT (PWS)

Maintenance & On-site Support Naval Medical Center Portsmouth, VA (NMCP)

SRRB UID 00183195289

1.0. GENERAL INFORMATION

General. NMCP has a requirement for a non‐personal service and maintenance contract for designated, Government-owned Philips Healthcare, IntelliVue MP5, Monitoring System, Physiologic Acute Care, Monitor, Bedside Physiologic Modular, IntelliVue Multi-Measurement Server 19” Display, IntelliVue MP30, Flexible Modular Server, IntelliVue MP70 Touchscreen, IntelliVue MP50, IntelliVue MX40 1.4 GHz Smart Hopping, Remote Antenna, Animation Synch Unit Assy, H10 PC Hardware, H20 UPS Hardware, Smart Hopping 1.4 GHz AP, Smart Hopping APC and Hemodynamic Measurement Server according to this PWS. Technical Exhibit 1 references the full equipment list. Maintenance and support shall be provided for a one (1) year period of performance from 03 January 2021 through 02 January 2022 with four (4) subsequent option years.

1.1. Scope. The Contractor shall maintain all equipment listed in the PWS. The Contractor shall maintain the systems within the original equipment manufacturer’s (OEM) specifications, in accordance with all United States (U.S.), State, and Local laws and regulations, U.S. Navy regulations, instructions, and Joint Commission requirements. The Joint Commission’s requirements are specified in its Comprehensive Accreditation Manual for Hospitals (CAMH), readily found on https://www.jointcommission.org/. U.S. Navy regulations and instructions will be made available upon request. The Contractor shall maintain any networkable systems such that they meet Navy and Defense Health Agency (DHA) Cybersecurity requirements.

1.1.1. The firm, fixed-price (FFP) maintenance contract shall include unlimited telephone support (twenty-four (24) hours, seven (7) days a week), preventive maintenance and inspections, corrective maintenance tasks, and unlimited emergency responses by the Contractor’s Field Service Engineers for all medical devices listed in Technical Exhibit 1. 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 shipping for the scheduled, preventive, and corrective maintenance of all equipment identified.

1.1.2. When product recalls, updates, or upgrades are necessary to maintain the contractual equipment inventory within the OEM’s specifications, the Contractor shall obtain and install same.

1.1.3. The aggregate amount of equipment covered under the contract 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 changes to the equipment list will be executed through an official contract modification.

1.1.4. The Contractor shall provide unscheduled support/service coverage from 0800 through 1700 hours (Local Time), Monday through Friday, unless otherwise specified, excluding United States Federal Government holidays, which are identified online at the following website: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay.

1.1.5. Government Points of Contact.

Contracting Officer’s Representative: To be provided after award.

Technical Liaisons: To be provided after award.

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

2.1. Alternate Contracting Officer’s Representative (ACOR). A Government employee appointed by the Contracting Officer (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 contractor performance reports.

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 Contractor 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 3.7.2.

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 patient, 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 Engineers shall submit a signed service report, in English, to the COR and Biomedical Equipment Technician (BMET) Technical Liaison (TL) for data entry into DMLSS. The service report shall include all information outlined in Section 3.9.2 of the contract.

3.1. Contractor’s Qualification: The Contractor shall be an OEM-certified service provider. The Contractor shall 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 Engineers (Engineers) 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. Field Service Engineers shall have sufficient experience to demonstrate proficiency in maintenance of the Government-owned product(s).

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

3.1.1.3. Government Right of Refusal: NMCP reserves the right to reject any of the Contractor’s personnel and refuse them permission to enter the premises or work on NMCP 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 shipping necessary to complete repairs and preventive maintenance on all equipment listed within this contract and shall not invoice NMCP for 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 PWS.

3.1.2. Technical documentation: The Contractor shall obtain, have on file, and make available to its Field Service Engineers 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 OEM to perform the same work. The Contractor shall ensure that all Field Service Engineers possess the ability to perform corrective software updates/upgrades and OEM or Food and Drug Administration (FDA) recall notices, and are in possession of legally licensed diagnostic software necessary for rapid, efficient, and effective maintenance.

3.1.3. Tools: The Contractor shall provide suitable, OEM-recommended repair equipment or tools required for the satisfactory execution of all repairs made on Government-owned equipment.

3.1.4. In order to travel freely onto and off of the military installation at NMCP, Field Service Engineers may have to undergo background checks, the Rapid Gate process, the Defense Biometric Identification System (DBIDS) process, or a similar process.

3.1.5. 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 shall ensure that 100% of all periodic maintenance is performed within thirty (30) calendar days of due date. Preventive maintenance visits shall include complete inspection and testing of the equipment in accordance with DMLSS maintenance procedures and/or manufacturer’s recommended guidelines.

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) calendar days before the maintenance 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 COR or TL 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. This information shall then be provided to Naval Medical Logistics Command (NMLC) Maintenance Engineer and KO for appropriate modification of the agreement.

3.2.3. Preventive Maintenance Scheduling: The Contractor shall schedule preventive maintenance visits as specified for each equipment item. For all equipment listed in Technical Exhibit 1, the frequency of preventive maintenance will be determined by the DMLSS property database, dependent on device codes, unless the OEM PM (preventive maintenance) periodicity is more frequent. The Contractor shall coordinate with NMCP’s Biomedical Engineering Department (BIOMED) and/or the TL to ensure the preventive maintenance completion month(s) are aligned with the due date(s) for each device set forth in DMLSS. The schedule is to be documented at the beginning of the contract period with a copy provided to the Contractor, COR, TL, and BIOMED.

3.2.3.1. Preventive maintenance visits shall be scheduled with BIOMED at least one (1) month in advance. If the routine procedural scheduling for clinical use of equipment items is in excess of one (1) month in advance, then the preventive maintenance visits shall be coordinated at least that far in advance, so as to not require rescheduling patients.

3.2.4. 100% Preventive Maintenance: Under the circumstances of 3.2.1 or 3.2.2, 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 removed from Technical Exhibit 1 via official contract modification.

3.2.5. Off-site Preventative Maintenance: Some equipment or devices may require that preventative maintenance be completed outside of the MTF. In this case, the Contractor shall still follow all procedures set forth by this agreement. No equipment shall be removed from MTF premises without the approval and signature of the COR, Technical Liaison, or their designated Biomedical Engineering representative. Preventive maintenance visits shall be scheduled with the Biomedical Engineering Department at least one (1) week (forty (40) working hours) in advance. If the routine scheduling for the equipment items is in excess of one (1) week in advance, then the preventive maintenance visits shall be coordinated at least that far in advance, so as to not require rescheduling patients.

3.2.6. Loaned Equipment: Before and whilst select equipment is removed from the MTF for OEM PM completion, the Contractor shall provide an alternate, loaned device to be used to meet clinical requirements. The temporary replacement shall be the exact same model, iteration, and quality as the Government-owned equipment.

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 and/or Joint Commission requirements. Corrective maintenance shall include repairs for all listed equipment to include problems resulting 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. The Contractor shall not accept any trouble calls other than through BIOMED. Contractor trouble call intake from BIOMED shall include a work order number, indicating that the equipment failure and service needed is properly recorded and included in the equipment’s maintenance history.

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

3.3.3. Repair by exchange: If any patient monitor, listed in Technical Exhibit 1, cannot be repaired or maintained for clinical use, the patient monitor(s) shall be replaced. Replacement(s) shall be sent to NMCP within eight (8) business hours of patient monitor damage disposition. Replacement(s) shall be the exact same part/model number, generation, and image quality of equipment as the previous patient monitor prior to its damage. Contractor shall provide unlimited replacement quantities for patient monitors, listed in Technical Exhibit 1.

3.3.4. All “repair by exchange” shall be approved in advance by the COR and/or TL.

3.3.5. Response time: Within one (1) hour of notification by the NMCP BIOMED, Contractor technical personnel shall respond by telephone. If the equipment cannot be restored to the operating condition via telephone technical support, the Contractor personnel shall arrive onsite within eight (8) hours to complete the requested service, repair, or provide a replacement (patient monitors). The onsite response time is measured from the time the Contractor is originally called, not from the time the Contractor returns the call. On-site responses shall only be rendered under this contract during the 0700 to 1700 local time support hours.

3.3.6. Telephone Support: Telephone consultation shall provide instruction in determining operator error, determine the most likely cause of the problem, determine if resolution of the problem requires the dispatch of a FSE, and identify replacement parts likely to be required in order to return the equipment to 100% operational condition, as specified by the OEM.

3.3.7. Software maintenance is within the scope of the contract, including updates and patches as needed, at no additional cost to the Government. The Contractor shall provide software revisions and updates, via field service changes, as required by the FDA or manufacturer announced safety-hazard recalls. Updates shall be performed as soon as possible after release, no later than the first scheduled Preventative Maintenance Inspection following release. Any updates that have been identified as critical, or required for the proper operation of equipment, shall be installed within thirty (30) calendar days of release.

3.4. Overtime: Overtime services are not part of this contract. If any overtime work needs to be done, it would need to be added to the contract via an official contract modification or award of a separate contract action.

3.5. Recalls and Updates: For all equipment covered under this contract, the Contractor shall resolve all FDA recalls, manufacturer recalls, and other mandatory updates within thirty (30) calendar days of the OEM’s public notification. The Contractor shall provide documentation of such installation and mandatory updates.

3.6. 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. The Contractor shall supply new, non-refurbished OEM parts, lubricants, and lubricant wear points for all repairs. 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). Replacement parts shall be furnished within one (1) business day. 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.

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

3.8. 100% Completion During Hours of Work: Work required in the performance of this contract shall be performed Monday through Friday, 0800 to 1700 (Local Time), excluding United States Federal Government holidays. The Contractor shall also provide a telephone consulting service, twenty-four (24) hours per day, seven (7) days a week. This telephone 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.

3.9. Service Events: Upon arrival on-site, prior to performing any work, Field Service Engineers shall physically sign in with BIOMED during normal working hours. On holidays, the duty BMET shall be contacted. The COR, TL, and/or any BIOMED Personnel may accompany the field service person as an observer during any work performed on-site.

3.9.1. 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: https://www.secnav.navy.mil/doni/Directives/05000%20General%20Management%20Security%20and%20Safety%20Services/05-100%20Safety%20and%20Occupational%20Health%20Services/5100.23G%20w%20CH-1.pdf. NMCP BIOMED will assist with this Lock Out/Tag Out effort, as long as they are made aware prior to the Contractor leaving the MTF.

3.9.2. 95% Service Event Documentation: Upon completion of each preventive maintenance visit and each corrective maintenance visit, Field Service Engineers shall submit a signed FSR to BIOMED. The service report shall indicate all problems addressed, devices checked, parts replaced/repaired, parts ordered, and problem resolution or pending action. Each service report shall 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 and no separate payments will be made for the services provided. This is a firm fixed price contract, meaning the contract will be reimbursed at an agreed upon monthly rate regardless of the amount of work performed each month.

11. Signatures:

a. Contractor performing service

b. BMET verifying service rendered

3.10. 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 electronic 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) calendar day of the following month.

3.11. Test equipment: The Contractor shall ensure that all test equipment and/or calibration standards, which are to be used in the performance of this contract, are traceable and certified in accordance with National Institute 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 shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on MTF equipment. In the event the test equipment and/or calibration standards are calibrated/certified throughout the course of this contract, the latest calibration/certification documentation shall be submitted to BIOMED.

3.12. Removal of equipment from site: No equipment shall be removed without the approval of the COR, duty BMET, and Command Equipment Manager. Security/property passes for equipment removal shall be obtained by the Contractor personnel 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.

3.12.1. 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 shall 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.

3.12.2. 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. The Contractor shall provide alternate, interim loaned unit(s) for any equipment requiring repairs outside of the Materials Management Department, BIOMED, NMCP.

3.12.3. Hard Disk and Solid State Drives (HDD & SSD): In regards to patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing patient information from the NMCP. HDD nor SSD shall ever be removed from the MTF, by the Contractor under this maintenance agreement.

3.12.4. 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.

3.13. Uptime: Equipment shall be returned to operational condition within twenty-four (24) hours after telephone notification from BIOMED.

3.13.1. Uptime Rate: The Contractor shall maintain an overall uptime rate of 95% or better for all equipment listed in Technical Exhibit 1. Uptime is equal to equipment availability minus down time. Uptime and down time are values used to calculate the mean time between failures (MBTF).

3.13.2. 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 NMCP, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations may be used to compute these metrics.

Variables Definitions:

U= Possible Equipment Uptime (100%) H= Hours of Coverage per day H1= Begin Coverage Time during each day H2= End Coverage Time during each day A= Number of covered days of the week W = Weeks of Coverage in a Year C= Uptime Commitment (per Section 3.13.1.)

Known (for this contract, per Section 1.1.4. & 3.13.1.):

H1= 0800 hours H2= 1700 hours A= Five (5) days per week W= Fifty-two (52) weeks per year C = 95%

Calculations:

D= Hours of Calculated Downtime (Unknown) T= Total Actual Uptime Percentage (Unknown) Δ= Percentage difference from Uptime Commitment (Unknown)

*Note* - Downtime hours shall fall within the Contractor’s hours of coverage listed in Section 1.2.4. Downtime hours outside of the coverage timeframe listed in Section 1.2.4. shall not be calculated as a metric of Contractor performance. Downtime ends once the system is available for full clinical use.

3.14. End of Service Life: For all equipment, hardware, software, and accessories, covered under the terms and conditions of this contract, the Contractor shall notify the COR and Naval Medical Logistics Command prior to the equipment’s commercial end of service life (EOSL). This notice shall be delivered in a timely manner, in writing on the Contractor’s letterhead, via email to at least the following address: to be provided after award.

3.14.1. This specific contract deliverable shall supplement, but not supersede, any existing, external ‘End of Service Life Notification’ requirements, as set forth by other Government agencies, such as the FDA or the Joint Commission.

3.14.2. Delivery of this letter shall not immediately remove the Contractor’s liability of covering the equipment under the terms and conditions of this contract. Its delivery shall simply be a means to start a dialogue with the COR and NMCP about the parameters associated with the commercial EOSL for the specific make/model of medical equipment.

4. SAFETY REQUIREMENTS: The Contractor shall take safety precautions as the COR or his/her designee may determine to be reasonably necessary to protect the lives and health of occupants of buildings in which work is being performed. The MTF shall notify the Contractor of any non-compliance with the foregoing conditions and the action(s) to be taken. The Contractor 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 Contractor 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 MTF REGULATIONS: Field service personnel shall wear visible photo identification at all times while on the premises of the MTF. It is the responsibility of the field service personnel to park in the appropriate designated parking areas. Information on parking is available from MTF Security personnel. Smoking is strictly prohibited inside any buildings of the MTF. Possession of weapons, alcohol, or pharmaceuticals that are not over the counter and not prescribed to the individual/family is prohibited on the MTF premises. Enclosed containers, including tool kits, are subject to search. Violations of MTF regulations may result in citation answerable in the United States (Federal) District Court. Violation of any policy which results in lost time for 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 patients, 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: The Contractor shall 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 sixty (60) calendar 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 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. Contractor personnel shall participate in activities of NMCP that are designed to meet the requirements of The Joint Commission, when requested by the COR or TL.

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 will 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 will 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 twenty-four (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, which means that the Contractor shall not be eligible to claim expenses to bring the equipment up to manufacturers’ specifications.

9.6. Phase Out of Service: Upon expiration or termination of this contract, the Contractor, at the Contractors’ expense, shall provide OEM certifications for all equipment covered under the contract at the rates/discounts normally provided to Government customers. If repairs or corrections to the equipment have to be made to obtain such certifications, the Contractor shall arrange to have those repairs or corrections 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. Contractor Supplies and Equipment. The Contractor supplies and equipment shall comply with Federal, State, municipal, and industry or OEM specifications.

11.3. 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.

11.4. The Contractors personnel shall comply with the applicable Department of Defense (DoD) Information Assurance Policies.

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

12. OCCUPATIONAL HEALTH.

12.1. Occupational Health/Immunizations: The Contractor personnel shall be immunized annually with the influenza vaccine with the Contractor bearing the total cost. On an annual basis, Contractor shall provide a current Purified Protein Derivative (PPD) reading or an evaluation if they are a known PPD reactor. The Contractor is responsible for any expenses incurred for required testing. Contractors shall maintain a Drug Free Workplace, as well as to require any subcontractors to do the same.

13. SUPTXT204-9400(3-19) CONTRACTOR UNCLASSIFIED ACCESS TO FEDERALLY CONTROLLED FACILITIES, SENSITIVE INFORMATION, INFORMATION TECHNOLOGY SYSTEMS OR PROTECTED HEALTH INFORMATION

The security text does not apply in cases where the contractor/vendor does not have access to Navy Marine Corps Intranet (NMCI) computers, is not issued a Common Access Card (CAC) and is involved in training or other short term duties of less than 30 days duration that allow for the use of a visitor request. In these cases, the government employee must submit a Visitor Access Request (VAR) to the main gate or applicable processing entity for your facility and assume responsibility to escort those without CAC Credentials.

This clause does not apply to non-United States (U.S.) Nationals (foreign nationals) who are contactor employees performing work overseas. The clause is applicable to the U.S. Nationals living in the U.S. or overseas who are performing work on a Navy contract.

The investigation of a non-U.S. national at a foreign location must be consistent with a National Agency Check with Written Inquiries (NACI), to the extent possible and include a fingerprint check against the Federal Bureau of Investigation (FBI) criminal history database, an FBI investigations file (name check) search and a name check against the terrorist screening database. Also, the above cited reference notes that Foreign Nationals may not be granted CAC credentials until completion of their investigation and not in the interim.

Per Department of Defense Memorandum (DoDM) 5200.2, Department of Defense (DoD) components must initiate and ensure completion of a background investigation before applying the credentialing standards to a non-U.S. national at a foreign location. The background investigation must be favorably adjudicated before a CAC can be issued to a non-U.S. national at a foreign location. The type of background investigation may vary based on standing reciprocity treaties concerning identity assurance and information exchanges that exist between the U.S. and its allies or agency agreements with the host country.

CONTRACTOR UNCLASSIFIED ACCESS TO FEDERALLY CONTROLLED FACILITIES, SENSITIVE INFORMATION, IT SYSTEMS OR PROTECTED HEALTH INFORMATION

Executive Order 13467, Reforming Processes Related to Suitability for Government Employee, Fitness for Contractor Employees and Eligibility for Access to Classified National Security Information, Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The 5 Code of Federal Regulations (CFR) 32 Part 157 in concert with DoD Manual 1000.13, Vol 1, implements the Federal Standards.

APPLICABILITY

This text applies to all DoD sponsored individuals who require CAC eligibility (or login and P/W if acceptable per contract) for: Physical access to DoD facilities or non-DoD facilities on behalf of DoD; Logical access to information systems (whether on site or remotely); or remote access to DoD networks that use only the CAC logon for user authentication, or access to sensitive and protected information. This applies to the Office of the Secretary of Defense (OSD), the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the DoD, the Defense Agencies, the DoD Field Activities and all other organizational entities within the DoD (hereinafter referred to collectively as the "DoD Components").

Each contractor employee providing services at a Navy command under this contract is required to obtain a 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 Command's Security Manager (CSM) upon arrival to the command and shall out-process prior to their departure at the completion of the individual's performance under the contract.

START-UP PERIOD

All contractor resource onboarding documents must be submitted via the prime contractor. The prime contractor shall make all necessary preparations to assume full responsibility for productive performance as of the performance start date.

Definition of "productive":

a. Visit Authorization Request (VAR)

b. Contractor Information Sheet (CIS)

c. FD-258 Fingerprint Card

d. Completed Electronic Investigation (EQIP)

e. All contractor resource(s) must have an active Joint Personnel Adjudication System (JPAS) profile

f. Common Access Card(CAC)

Note (1): Invoicing by the contractor will begin as of the commencement of the performance period of services and no reimbursement will be paid by the government for efforts expended during the start-up period.

Note (2): Foreign Nationals are not allowed access to the functional/system side of Enterprise Resource Planning (ERP).

ACCESS TO DOD INFORMATION TECHNOLOGY (IT) SYSTEM

In Accordance With (IAW) Secretary of the Navy (SECNAV) M-5510.30, contractor employees who require access to Department of the Navy (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 sensitive information. Sensitive information includes information protected under the Privacy Act, to include 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 System Security Manager (ISSM)/Information Assurance Manager (IAM).

Contractor employees requiring privileged or IT-I level access, (when specified by the terms of the contract) require a Single Scope Background Investigation (SSBI) or T5 or T5R equivalent investigation, which is a higher level investigation than the National Agency Check (NAC) with Law and Credit (NACLC)/T3/T3R described below. Due to the privileged system access, an investigation suitable for High Risk national security 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 (IA) Technical Level 1, and must be trained and certified on the Operating System (OS) or Computing Environment (CE) 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 CSM and ISSM/IAM 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 IT 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-N; therefore, the government employee with knowledge of the system/network access required or the Contracting Officers Representative (COR) shall sign the SAAR-N as the supervisor.

The SAAR-N shall be forwarded to the CSM at least thirty (30) days prior to the individual's start date. Failure to provide the required documentation at least thirty (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 Cyber Awareness training, and maintain a current requisite background investigation. The contractor's security representative shall contact the CSM for guidance when reinvestigations are required.

INTERIM ACCESS

The CSM 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…