PWS.docx

HT941024P0083

Department of Defense Defense Health Agency Performance Work Statement

SINGLE LINEAR ACCELERATOR SMA PWS

Naval Medical Center San Diego

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide contracted maintenance for designated Government-owned Varian Linear Accelerator Radiotherapy System hardware and associated software.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform non-personal services and maintenance for designated Government-owned Varian Linear Accelerator Radiotherapy System hardware and associated software as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: The Radiation Oncology Department at Naval Medical Center San Diego (NMCSD) utilizes two Varian linear accelerator radiotherapy system (Clinac Trilogy Silhouette [H140971]). These dual energy source linear accelerator system provide treatment for patients diagnosed with oncologic tumors in various areas of the body, such as the head, neck, breast, pelvis, and the thoracic region. The linear accelerator radiotherapy system are designed to target and, with specific photon energy beams, strike the cancerous cells, so as to reduce their size or eradicate them altogether. Because of the complexity of the system and software, they require regular service and maintenance.

These linear accelerator radiotherapy system must be properly maintained by an OEM-trained engineer, who will conduct scheduled preventative maintenance quarterly, administer corrective services, and apply potential system updates. These services must be performed in accordance with OEM standards, in order to ensure optimal patient care and safety. Procuring a maintenance contract for the system will decrease device downtime and prevent large, unpredictable one-time maintenance costs. A maintenance agreement will also prevent the Government from sending patients out to the commercial healthcare space, further avoiding excessive costs.

· Preventive maintenance

· Emergency maintenance

1.5 Scope: The contractor shall provide preventive and corrective maintenance services for all equipment identified in the Technical Exhibit 1 to include but not limited to unlimited telephone support, regularly scheduled preventive maintenance, inspections, calibrations, corrective maintenance tasks, unlimited emergency responses, and remote support (as allowable, via any existing authorized Defense Information Systems Agency (DISA) Business to Business Gateway). Coverage shall be included for all Linear Accelerator Radiotherapy System, subsystem components, and assemblies listed in the performance work statement. 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 the 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 laws 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 https://www.jointcommission.org. US 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.

1.5.1 The equipment identified in Technical Exhibit 1, aggregate requirement and level of effort will remain relatively constant and 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 identified in the Technical Exhibit 1 will be executed through an official contract modification.

1.5.2 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 provided in the table below:

Table 1: Maintenance Schedule

May 2025

August 2025

November 2025

February 2026

1.6 Period of Performance (PoP): Maintenance and support shall be provided for a 12-month base period plus one 12-month option period for all equipment listed in Technical Exhibit 1, as referenced in each Contract Line Item Number (CLIN).

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at Naval Medical Center San Diego (NMCSD) between the hours of 7:30 AM and 5:00 PM, local time, from Monday through Friday, excluding Federal Government holidays (PWS Section 1.7.2), unless otherwise specified in the Technical Exhibit 1. The contractor shall provide telephonic and email technical support during standard business hours (Monday-Friday, 7:30AM-5:00PM, local time).

1.7.2 Recognized Federal holidays:

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday, 730 AM - 5:00 PM, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7.5 Government Points of Contact

Contracting Officer Representative (COR):

Mr. Jesse A. Bell DHA San Diego, NMCSD Email: jesse.a.bell2.civ@health.mil Phone: (619)532-8010

Technical Liaison:

TBD

Chief Petty Officer, Biomedical Equipment Repair Department, NMCSD Email: TBD Phone: (619) 532-TBD

1.8 Contractor travel: The contractor shall provide for all travel to Naval Medical Center San Diego to attend meetings, complete repairs, and perform preventive maintenance on all equipment listed on this contract. Contractor shall be authorized travel expenses consistent with the cost principles and procedures in Federal Acquisition Regulation (FAR) Part 31.2, Travel Costs and the limitations of funds specified in this contract. All travel requires Government approval/authorization and notification to the COR. All travel costs shall be in accordance with the limitations of the Joint Travel Regulations (JTR).

1.9 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

Reference

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

1.11 Contractor personnel

1.11.1 Defense Biometric Identification Systems (DBIDS)

(a) In accordance with Commander, Navy Installations Command (CNIC) Memorandum dated 05 May 2017, individuals currently using the Navy Commercial Access Control System (NCACS) credential for Installation Access are required to switch to a DBIDS no later than 14 August 2017. After 14 August 2017, the NCACS credential will no longer be valid for access to Navy Installations.

(b) NCACS users may visit the local Navy Installation Visitor Control Center to obtain a DBIDS credential. To ensure uninterrupted Installation access, current NCACS credential holders are encouraged to shift to the DBIDS credential as soon as possible as Navy does not have the ability to extend this deadline. There are no fees incurred by the contractor, vendor, or supplier to obtain a DBIDS credential.

(c) Individuals who apply for NCACS credentials during the period of 17 April through 31 May 2017 must also obtain DBIDS credentials. NCACS credentials issued after 17 April 2017 will no longer be accepted without an accompanying DBIDS credential for Navy Installation access.

(d) DBIDS guidance for Vendors/Contractors to obtain a pass is accessible through the following website: https://www.cnic.navy.mil/om/dbids.html

For more information or to enroll in the DBIDS Program, call: (202) 433-4784. For Naval Base San Diego Pass and Decal Office, call: (619) 556-1653.

(e) Vendors, contractors, suppliers and other service providers shall present their pass upon entry at Entry Control Point (ECP).

1.11.2 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.12 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the COR/CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 7:30 AM and 5:00 PM, local time in San Diego (PST), Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.13 Reporting

1.13.1 Contractor Manpower Reporting (CMR): RESERVED.

1.13.2 Non-Disclosure Agreement (NDA): All contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA contractor NDA (DHA Form 49) prior to beginning work on the subject contract. The contractor shall execute an NDA on behalf of the company and shall ensure that all staff assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the contractor. The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.13.3 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.14 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.14.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

1.14.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.15 Contractor Access to Health Affairs (HA)/DHA Network(s) - Reserved.

1.16 Personnel Security - see Part 6 below for details.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 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.

2.1.6 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.7 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.1.8 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.

2.1.9 Field Service Report (FSR) (Technical Exhibit 3). Documentation completed by vendor personnel to officially record all instances of contracted troubleshooting, work, and services conducted on equipment must submit to the Biomedical Equipment Repair. Specifics on required reporting details can be seen in Section 5.8.2.

2.1.10 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.

2.1.11 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.

2.1.12 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)

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

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

2.1.15 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).

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

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

2.1.18 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.

2.1.19 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.

2.1.20 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.

2.2 Acronyms:

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc. Reserved.

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Government will not provide Government - Furnished Services and/or equipment in support of this contract.

1.1 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.

1.2 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, if any.

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 The 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.

4.2 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, the Contractor shall keep NMCSD safe, neat, clean and orderly. Contractor shall be responsible for all means, methods, techniques, sequences, and procedures of services. Contractor employees shall demonstrate appropriate behavior and dress at all times.

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

4.4 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 and its Oncology Department locations. 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.

4.5 The Contractor’s personnel shall comply with the applicable DoD Information Assurance Policies.

4.6 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 are required to maintain a Drug Free Workplace, as well as to require any sub-Contractors to do the same.

PART 5

5.0 SPECIFIC TASKS

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. 5.8.2 of the PWS.

5.1 Service Vendor’s Qualification: The Contractor must be an Original Equipment Manufacturer (OEM) certified 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.

5.1.1 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 Technical Exhibit 1. Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product.

5.1.1.1 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.

5.1.1.2 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 CO and/or COR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

5.1.1.3 Government Right of Refusal: NMCSD reserves the right to reject any of the service vendor’s personnel and refuse them permission to enter 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 limited to: behavior, attire, security concerns, and immigration status.

5.1.1.4 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.

5.1.2 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.

5.1.3 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.

5.2 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 following the due date.

5.2.1 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.

5.2.2 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 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.

5.2.3 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 the 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 schedule 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.

5.2.4 100% Preventive Maintenance: Under the circumstances of 5.3.1 or 5.3.2, 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.

5.3 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 Federal Drug Administration (FDA) requirements. Corrective maintenance services shall include damage to equipment that results from, but not limited to, normal wear and tear, component part failures, environmental issues (e.g., water damage), etc. Corrective maintenance services shall not include unintentional damage and operator error. Any maintenance services for unintentional damage and operator error will be billable under time and material terms.

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

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

5.3.3 Response time: Within one (1) hour of notification, Contractor personnel shall respond by telephone. If the equipment cannot be restored to the operating condition via telephone, the Contractor personnel shall arrive onsite within two (2) hours. If the call for service is placed after 3:00 PM and the Contractor personnel cannot arrive before the end of the standard work day (5:00 PM), the Contractor personnel shall be onsite the next standard business day no later than 7:30 AM. 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 twenty-four (24) hours from the time the Contractor is initially contacted.

5.3.4 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 Technical Exhibit 2. 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 fee”, where required). Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of part, shall be responsibility of the Contractor.

5.3.5. Software Maintenance is included in the scope of this contract, including upgrades and patches as needed.

5.3.6. In the event that a corrective maintenance is started within, but cannot be completed within, standard business hours (7:30 AM - 5:00 PM), 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 weekday, the COR and NMCSD BIOMED shall be notified prior to performance. No overtime services shall be completed without 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 of associated services by the COR and/or CO.

5.4. 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. Any additional training sessions will be billable events under time and material terms.

5.5. 100% Completion During Hours of Work: Work required in the performance of this contract shall be performed Monday through Friday, 7:30 AM - 5:00 PM (local time), excluding Federal Government holidays, unless otherwise specified in the preventive maintenance and repair schedule in the 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 7:30 AM - 5:00 PM 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 another means, is authorization to provide services not specifically covered by the terms of the contract. No overtime shall be billed to the Government.

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

5.6.1. 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:

Uptime Basis Downtime Basis

Basis = Total treatment hours - Scheduled Maintenance (Planned Maintenance) *Note* - Downtime hours must fall within the vendor’s hours of coverage listed in Section 1.7.1.

5.7. Recalls and Updates: The Contractor complies with all recall regulations applicable to its products. All procedures relating to medical device recalls are governed by the FDA or other global regulatory authority. Any notices regarding recall will comply with the applicable regulatory authorities notice and implementation requirements for all affected Varian customers.

5.8. Service Events: Upon arrival on-site, prior to performing any work, field service personnel shall physically sign in with the NMCSD BIOMED during normal working hours. The COR, Biomedical Technical Liaison, and/or any Biodmed Personnel may accompany the field service person as an observer during any work performed on-site. Contractor will be required to contact the Medical Repair Branch at (619) 532-8010 to submit the required information to complete the NMCSD Security Pass Form by 1400 the day prior to the scheduled visit. In the case of emergent repairs/service, the Contractor will wait at the main gate for an escort from Medical Repair Branch personnel.

5.8.1. Lock Out/Tag Out: The Contractor shall personally notify BIOMED, via FSR (Technical Exhibit 3), 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://doni.documentservices.dla.mil/allinstructions.aspx.

5.8.2. 95% Service Event Documentation: Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel must submit a signed FSR to the Biomedical Equipment Repair. The service report shall indicate al 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, and telephone number.

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 of Arrival

8. Date & Time, beginning and ending, of hours on-site for service call

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

10. Resolution and/or pending action(s)

11. 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

12. Signatures:

a. Contractor performing service

b. BMET verifying service rendered

13. Summary of Work Performed and Accepted By End-User (Government Representative’s Printed Name and Signature) Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR) to the Duty Staff at: Naval Medical Center San Diego Bio Medical Repair Building 6, 3rd Floor, Room GD-18H1 Phone: (619) 532-8010 Fax: (619) 532-8013

Bio Medical Repair Chief: HMC (FMF/SW) Dandy A. Robeniol Phone: (619) 532-5144 Or electronically at: ca@ined.navy.mil. The Contractor, or his representative, shall complete the vendor supplied Field Service Report as detailed above. All Field Service Reports shall be submitted within 72 hours of completion of service. Completed Field Service Reports are required prior to acceptance of any invoice.

5.9. 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.

5.10. 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 the 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.

5.11 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 as the sole responsibility of the service contractor personnel.

5.11.1 Removal Report: The Contractor shall provide a detailed description of removed items in writing on the Contractor’s company letterhead. For associated items/accessories, the 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 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.

5.11.2 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.

5.11.3 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.

5.11.4 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.

5.12 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 CO 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.

5.13 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.