Sol. HT940623R0012 PWS_Amended_7Aug23.pdf

Department of Defense Defense Health Agency

Performance Work Statement Amendment 1 – 7 August 2023

Medical Laser Preventive and Corrective Maintenance

Naval Medical Center, Portsmouth VA

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide maintenance support and original equipment manufacturer (OEM) repair/replacement parts, and on-site support for designated Government-owned laser units.

1.2 Description of services/introduction: Specific laser units, will be identified in the Equipment List (Part 5, Attachment 1). The contractor shall provide preventive and corrective maintenance services for all equipment listed in Part 5, Attachment 1, unless otherwise stated. The Contractor shall maintain the equipment within the original equipment manufacturer’s (OEM) specifications, in accordance with all United States (US), State, and Local laws and 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.

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.

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

To support mission operations, these systems must be maintained by a knowledgeable and trained Biomedical Equipment Technician. Furthermore, new original equipment manufacturer (OEM) parts must be readily available for each and every repair. NMC Portsmouth requires this contracted support and provided OEM parts, so as to prevent unforeseen downtime, to avoid unnecessary costs, and to inhibit patient impact.

1.4 Objectives: Equipment listed in this contract will be certified to meet the original equipment manufacturer’s (OEM) specifications.

1.5 Scope: Maintenance shall include unlimited 24 hours a day, 7 days a week (24x7) telephone support, regularly scheduled preventive maintenance, inspections, calibrations, corrective maintenance tasks, and unlimited emergency responses. Coverage shall be included for all systems listed in Part 5, Attachment 1, subsystem components, assemblies, corresponding integrated boilers, and water savers (i.e., Contractor is responsible for total maintenance of entire system). The Contractor shall maintain the system such that it meets Defense Health Agency (DHA) Cybersecurity requirements. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. The Contractor shall provide all labor, materials, travel, personnel, supervision, freight, and OEM non-refurbished parts for the scheduled (preventive) and unscheduled (corrective) maintenance for all equipment identified in Part 5, Attachment 1. The equipment list, see Part 5, Attachment 1, shall fluctuate over time, as hardware and software eclipse useful life and as new equipment comes off warranty. Any changes to the equipment list, see Part 5, Attachment 1, will be executed through a contract modification.

1.6 Period of Performance (PoP): Maintenance, support, and OEM parts shall be provided for a one (1) year base period from 01 October 2023 through 30 September 2024 with four (4) one-year option periods to extend services through 30 September 2028

1.7 Administrative specifications:

1.7.1 Place of performance: The work shall be performed at Naval Medical Center, Portsmouth (NMCP), located at 620 John Paul Jones Circle, Portsmouth, VA 23708.

1.7.2 Recognized Federal holidays: On site services not required on Federal Holidays.

Federal Holidays are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work- schedules-and-pay.

1.7.3 Hours of operation: The contractor shall provide scheduled and unscheduled support/service coverage between the hours of 0800 and 1700, Monday through Friday, excluding Federal Government holidays 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.

1.7.4 Emergency Services: N/A

1.8 Contractor travel: N/A

1.9 Other Direct Costs (ODC): N/A

1.10 Quality

1.10.1 Quality Control (QC): N/A

1.10.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). Located in Section 5. 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).

1.11 Contractor personnel

1.11.1 CAC requirements: For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government all the required information per the DHA CAC request process current version 2.1, January 2018, or more recent when updated. See process attached at Part 7 Section 7.1.1 of the PWS. A CAC is the standard identification for eligible DoD contractor personnel.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s).

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements:

1.11.2.1 The DHA’s “Onboarding Checklist for Contractor Employees” is located at the DHA Onboarding and Offboarding Portal at https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx

1.11.2.2 The DHA’s contractor training instructions embedded at Part 7 Section 7.1.2.

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD- and DHA-directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at: https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note:

Public Key Infrastructure (PKI)-restricted, printed versions available). See Part 7 Section 7.1.1.

1.11.3 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.

1.11.4 Key control: Reserved.

1.11.5 Lock combinations: Reserved.

1.12 Key personnel (Contractor): N/A

1.13 Data rights: Reserved.

1.14 Reporting

1.14.1 Contractor Manpower Reporting (CMR): Reserved.

1.14.2 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.

1.14.3 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.

1.14.4 Post award conference/periodic progress meetings: N/A The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart

42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO will apprise the contractor of how the government https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.15 Contractor Identification

1.15.1 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.

1.15.2 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.

1.15.3 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.

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.16.1 Reserved

1.16.2 Reserved

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI)

6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM

5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.17.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.17.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

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. 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 CO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

2.1.4 Contracting Officer’s Representative (COR): A Government individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 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.

2.1.6 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.

2.1.7 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.

2.1.8 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.

2.1.9 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.

2.1.10 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 5.10.2.

2.1.11 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.

2.1.12 Reserved

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

2.1.14 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).

2.1.15 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.

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc. – N/A

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☐ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below:

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

The Government will operate the systems in accordance with the instruction manual(s) provided by the OEM.

The Government shall not be responsible, in any way, for damage to the Contractor’s supplies, material, equipment, or to Contractor’s employees’ personal belongings brought onto the site. The Government will not provide storage space for the Contractor’s equipment.

3.2 Facilities: The Government:

☒ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below: N/A

3.3 Utilities: The Government:

☒ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below: N/A

3.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below: N/A

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below: N/A

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders. These Services are described below:

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

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

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 NMCP 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.

4.2 General: The contractor shall furnish all supplies, equipment, facilities, and services required to perform work listed under Section 5 of this PWS.

4.3 Secret Facility Clearance: N/A

4.4 Materials: The use of Contractor provided two-way radios and cell phones for communication between personnel shall be approved by the Base Communications activity and may not be used in designated areas in NMCP. 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 Equipment: The Contractor supplies and equipment shall comply with Federal, State, municipal, and industry or OEM specifications.

4.6 Facilities: N/A

PART 5

5.0 SPECIFIC TASKS

5.1 The Contractor shall provide equipment maintenance services, to include all periodic planned maintenance, unscheduled repairs, and OEM parts, in accordance with OEM specifications, to include repairs necessitated by operator error. Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel shall submit a signed Field Service Report to the COR for data entry into DMLSS. The Field Service Report shall include all information outlined in Section 5.10.2 of the PWS.

5.2 Service Contractor’s Qualification: The Contractor shall be an Original Equipment Manufacturer (OEM) certified service provider. Contractors 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 non-immigrant classifications, may have employment authorization as a direct result of their immigration status.

5.2.1 Field Service Personnel shall be authorized by the OEM-certified service provider 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.

5.2.1.1 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.

5.2.1.2 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 personnel. This assurance shall be provided upon award and when new employees are added. The CO and/or COR may authenticate the training requirements and request training certificates or credentials from the Contractor at any time.

5.2.1.3 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.

5.2.1.4 Field engineers shall provide all OEM 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 NMCP for work performed at the direction of the Contractor.

5.2.1.5 In order to travel freely onto and off of the military installation at Naval Medical Center Portsmouth, Field Service Engineers may have to undergo background checks, the ‘Rapid Gate’ process, and/or the ‘Vendor Mate’ process.

5.2.1.6 Field engineers shall provide services in accordance with the performance requirements specified in this

PWS.

5.2.2 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 for or beneficial in speeding up the diagnosis, repair, or calibration of the equipment. The Contractor shall ensure that all Field Service Personnel possess the ability to perform corrective software upgrades and manufacturer recall notices and are in possession of legally licensed diagnostic software necessary for rapid, efficient, and effective maintenance.

5.2.3 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.

5.3 Preventive Maintenance: Contractor shall ensure that 95% or more of all periodic maintenance is performed within thirty (30) calendar days of the due date, and that 100% of periodic maintenance is performed within sixty

(60) calendar days of the due date.

5.3.1 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 and/or sixty (60) calendar days following the due date, the Contractor shall immediately notify the COR.

5.3.2 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. The Contractor shall arrange the performance via coordination with the COR during circumstances of unexpected delays, 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 request that the Contracting Officer adjust Part 5, Attachment 1, accordingly.

5.3.3 Preventive Maintenance Scheduling: For all equipment listed in Part 5, Attachment 1, the frequency of preventive maintenance will be determined by the Defense Medical Logistics Standard Support property database, dependent on device codes, unless the OEM PM (preventive maintenance) periodicity is more frequent. 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 NMCP BIOMED Department at least one month (30 calendar days) in advance.

5.3.4 100% Preventive Maintenance. Under the circumstances of Sections 5.4.1 or 5.4.2, 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.

5.4 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 Food and Drug Administration (FDA) requirements. Corrective maintenance shall be provided to equipment with damage resulting from, but not limited to, unintentional operator error, normal wear and tear, component part failures, environmental issues (e.g., water damage), etc.

5.4.1 The Government request for corrective maintenance will be placed by the NMCP BIOMED Department to the Contractor’s POC. Corrective Maintenance shall be completed during the hours identified in Section 1.7.3.

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

5.4.3 All “repair by exchange” shall be approved by the NMCP BIOMED Department in advance. “Repair by exchange” refers to completely replacing a piece of equipment or a system if repairs cannot return the original system to an operational state.

5.4.4 Response time: Within two (2) hours 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 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.

5.4.5 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.

5.4.6 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 Preventive Maintenance Inspection following release.

Any updates that have been identified as critical, or required for the proper operation of equipment, shall be installed within 30 calendar days of release.

5.4.7 Overtime: Overtime services, defined as worked performed outside of the hours defined in Section 1.7.3, are not part of this contract. If necessary to initiate services beyond 1700, local time on weekdays, or any times other than those specified in Section 1.7.3, the COR and NMCP BIOMED shall be notified prior to performance and a separate contract must be put into place by NMCP. Accordingly, no overtime shall be billed to the Government under this contract.

5.5 Preventive Maintenance and Repair Schedules. Completed Field Service Reports are required prior to acceptance of any invoice.

5.5.1 Services shall be required based upon the following agreed schedules:

Preventive Maintenance Corrective Maintenance Bi-Annually, in March and September, unless otherwise requested by the NMCP BIOMED Department

Corrective Maintenance shall be completed during the hours identified in Section 1.7.3

5.6 Parts: The Contractor shall provide coverage for all repair and replacement parts necessary to maintain the equipment, see Part 5, Attachment 1, within the parameters of the original manufacturer’s specifications.

5.6.1 The Contractor shall supply new, non-refurbished OEM parts, including only OEM-approved lubricants and lubricant wear points, for all repairs necessary to restore equipment to the original manufacturer’s specifications.

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

5.6.2 Replacement parts shall be furnished within the one (1) calendar day of parts ordering. Parts shall be requested by the NMCP BIOMED Department or by the contractor’s field service personnel. The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing systems.

5.6.3 In the event that replacement parts are required to be shipped, shipping shall be performed with next day air at no additional cost to the Government. If next day air is not available, then the Contractor shall ship by the next fastest means.

5.6.4 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.

5.7 Training: The Contractor shall provide one (1) initial training session for NMCP 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.

5.8 100% Completion During Hours of Work: Work required in the performance of this contract shall be performed during the hours specified in Section 1.7.3, unless otherwise specified. The Contractor shall also provide telephone technical support 24x7, excluding Federal Government holidays. This consulting service shall be provided to avoid undue delays in equipment repairs during after-hours and weekend 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.

5.9 Uptime Rate: The Contractor shall maintain an overall uptime rate of 95% or better, for all equipment listed in Part 5, Attachment 1.

5.9.1 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 NMCP, the uptime shall be calculated cumulatively for the entire duration of the contract. The following formula will be used to calculate uptime:

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 5.8)

Known (for this contract, per Section 1.7.3):

H1= 0800 hours H2= 1700 hours A= 5 days per week W= 52 weeks per year C = 95%

Calculations:

𝐻𝐻 =

𝐻𝐻2 − 𝐻𝐻1

1700 − 0800

= 9 𝐻𝐻𝐻𝐻𝐻𝐻𝐻𝐻𝐻𝐻 𝐻𝐻𝑜𝑜 𝐶𝐶𝐻𝐻𝐶𝐶𝐶𝐶𝐻𝐻𝐶𝐶𝐶𝐶𝐶𝐶 𝑝𝑝𝐶𝐶𝐻𝐻 𝑑𝑑𝐶𝐶𝑑𝑑

𝑈𝑈 = 𝐻𝐻 ∗ 𝐴𝐴 ∗ 𝑊𝑊 = 9 ∗ 5 ∗ 52 = 2,340 𝐻𝐻𝐻𝐻𝐻𝐻𝐻𝐻𝐻𝐻 𝐻𝐻𝑜𝑜 𝑃𝑃𝐻𝐻𝐻𝐻𝐻𝐻𝑃𝑃𝑃𝑃𝑃𝑃𝐶𝐶 𝐸𝐸𝐸𝐸𝐻𝐻𝑃𝑃𝑝𝑝𝐸𝐸𝐶𝐶𝐸𝐸𝐸𝐸 𝑈𝑈𝑝𝑝𝐸𝐸𝑃𝑃𝐸𝐸𝐶𝐶

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

𝑇𝑇 =

𝑈𝑈 − 𝐷𝐷

𝑈𝑈

2340 − 𝐷𝐷

∆= (𝐶𝐶 − 𝑇𝑇) ∗ 100 = (. 95 − 𝑇𝑇) ∗ 100

*Note* - Downtime hours shall fall within the Contractor’s hours of coverage listed in Section 1.7.3.

Downtime hours outside of the coverage timeframe listed in Section 1.7.3 shall not be calculated as a metric of contractor performance. Downtime ends once the system is available for full clinical use.

5.10 Recalls and Updates: The Contractor shall provide installation and mandatory updates (software or hardware) within 5 business days for Class I equipment recalls and 30 calendar days 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.

5.11 Services Events: Upon arrival on-site, prior to performing any work, field service personnel shall physically sign in with NMCP BIOMED during normal working hours. The NMCP BIOMED Department is located in Building 250 on the 1st floor. Phone contact can be made via calling 757-953-5336. The COR, BIOMED Technical Liaison, and/or any BIOMED Personnel may accompany the field service person as an observer during any work performed on-site.

5.11.1 Lock Out/Tag Out: The Contractor shall notify BIOMED, via Field Service Report, 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 Defense Health Agency regulations, specifically Title 29 1910.147 of the Code of Federal Regulations, 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.

5.11.2 95% Services Event Documentation: Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel shall submit a signed Field Service Report (FSR) to NMCP BIOMED 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 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 NMCP BIOMED personnel

9. Resolution and/or pending action(s)

10. Estimated total billing cost, if NMCP 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. NMCP Biomedical Engineering Technician (BMET) verifying service(s) rendered.

5.12 100% 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 the previous month’s activity shall be submitted no later than the fifteenth (15th) day of the following month.

5.13 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 shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on NMCP equipment.

5.14 Removal of equipment from site: No equipment shall be removed without the approval of the COR and Materials Management Department at NMCP. Property passes for equipment removal shall be obtained by the Contractor via the Materials Management Department at NMCP. 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.

5.14.1 Removal Report: Prior to removing the equipment/system from NMCP, 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 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 shall be included upon return of repaired components.

5.14.2 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.

5.14.3 Hard Disk and Solid State Drives (HDD & SSD): In regard to patient information’s confidentiality and privacy, Contractor personnel shall not remove equipment containing patient information from NMCP. HDD nor SSD shall never be removed from NMCP.

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

Part 5, Attachment 1:

NOTE: item ECN Number 105225 will be removed from the final equipment list. Do not include in any quote submitted.

SPECIAL REQUIREMENTS:

A. 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. NMCP 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 CO 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.

B. IDENTIFICATION, PARKING, SMOKING REGULATIONS: Field service personnel shall wear visible photo identification at all times while on the premises of NMCP. It is the responsibility of the field service

ECN Mfr. Serial No. Nameplate Model Nomenclature Manufacturer Common Model Customer Id Customer Name

76774 550337 STARLUX500 LASER, ND:YAG, FREQUENCY-DOUBLED, DERMATOLOGIC PALOMAR MEDICAL TECHNOLOGIES INC BAPA00 DMS - DERMATOLOGY

76909 991404000106 755 LASER, ND:YAG, DERMATOLOGIC CANDELA CORP GENTLEMAX BAPA00 DMS - DERMATOLOGY

76917 991404000074 ALEX TRIVANTAGE LASER, ALEXANDRITE, DERMATOLOGIC CANDELA CORP ALEX TRIVANTAGE BAPA00 DMS - DERMATOLOGY

105225 471 EX308 LASER, EXCIMER RA MEDICAL SYSTEMS BAPA00 DMS - DERMATOLOGY

111478 585 GA0000530 LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC LUMENIS INC ULTRAPULSE BAPA00 DMS - DERMATOLOGY

117843 1448346068 JOULE7 LASER, ER:YAG, DERMATOLOGIC SCITON INC BAPA00 DMS - DERMATOLOGY

121491 991403001998 VBEAM PERFECTA LASER, DYE, DERMATOLOGIC CANDELA CORP VBEAMPERFECTA BAPA00 DMS - DERMATOLOGY

134830 21216 M22 LASER, ND:YAG LUMENIS LTD M22 BAPA00 DMS - DERMATOLOGY

128439 J0592 FRAXELRESTOREDUA LASER DELIVERY SYSTEM, WAVEGUIDE SOLTA MEDICAL BAPA00 DMS - DERMATOLOGY

76798 GL16477C30 OCULIGHT GLX LASER, DIODE, OPHTHALMIC IRIDEX CORP BBDA00 DSS - OPHTHALMOLOGY

143935 10137 NORUS SPECTRA LASER, ND:YAG, FREQUENCY-DOUBLED, OPHTHALMIC LUMENIS INC NORUS SPECTRA BBDA00 DSS - OPHTHALMOLOGY

67022 162400216 1624 LASER, ER:YAG, DERMATOLOGIC ASCLEPION LASER TECHNOLOGIES 1624 BBGA00 DSS - PLASTIC SURGERY CLINIC/ 9D INCLUDE

100680 1475913 64240701 LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC LUMENIS INC BBGA00 DSS - PLASTIC SURGERY CLINIC/ 9D INCLUDE

117709 647 KT1005830 LASER, FEMTOSECOND PULSE LUMENIS INC BBGA00 DSS - PLASTIC SURGERY CLINIC/ 9D INCLUDE

140271 1212 ULTRAPULSEENCORE LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC LUMENIS INC ULTRAPULSE BBGA00 DSS - PLASTIC SURGERY CLINIC/ 9D INCLUDE

140799 23477 M22 LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC VWR INTERNATIONAL M22 BBGA00 DSS - PLASTIC SURGERY CLINIC/ 9D INCLUDE

146077 70092 GA1170000 LASER, RUBY, DERMATOLOGIC LUMENIS INC LIGHTSHEERDESIRE BBGA00 DSS - PLASTIC SURGERY CLINIC/ 9D INCLUDE

103328 3587 6088749 LASER, DIODE, DENTAL SIRONA USA CAAA00 DSS - DENTAL SERVICES BLDG. 2 - NMCP

129634 PL172078 PERIOLASEMVP7 LASER, ND:YAG, DENTAL MILLENNIUM DENTAL TECHNOLOGIES INC CAAA00 DSS - DENTAL SERVICES BLDG. 2 - NMCP

129635 PL172075 PERIOLSDRMVP7 LASER, ND:YAG, DENTAL MILLENNIUM DENTAL TECHNOLOGIES INC PERIOLASE MVP-7 CAAA02 NOT FUNDED - SP - DENTAL CLINIC

140156 PL192293 PERIOLASEMVP7 LASER, ND:YAG, DENTAL MILLENNIUM DENTAL TECHNOLOGIES INC PERIOLASEMVP7 CAAA02 NOT FUNDED - SP - DENTAL CLINIC

100679 1475912 64240701 LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC LUMENIS INC DFBA00 DSS - MAIN OPERATING ROOM

140432 LHT00650120 EMPH65S LASER, HO:YAG, SURGICAL OLYMPUS AMERICA INC EMPH65S DFBA00 DSS - MAIN OPERATING ROOM personnel to park in the appropriate designated parking areas. Information on parking is available from NMCP Security personnel. Smoking is prohibited inside any buildings of NMCP. Possession of weapons, alcohol, or pharmaceuticals that are not over the counter or are not prescribed to the individual/family is prohibited on NMCP premises. Enclosed containers, including tool kits, are subject to search. Violations of NMCP 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.

C. 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).

D. PROPERTY DAMAGE LIABILITY INSURANCE: Service vendors are required to have Property Damage

Liability coverage of at least $500,000.

E. MODIFICATIONS TO CONTRACT: Only the CO 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 CO.

F. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Performance Objective

Performance Standard

Acceptable Quality Level

Monitoring Method/Performance Assessment

PWS

Reference

Medical equipment essential to the healthcare delivery mission is properly maintained ensuring a safe environment of care for visitors and staff alike.

Preventive maintenance for all medical equipment under this contract is completed on or before the scheduled date.

95% of all periodic, preventive maintenance is performed within 30 days of the due date.

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

Contractor service reports, DMLSS data sampling by COR, and random physical spot checks by BMET personnel.

5.2

Accurate and timely submission of information critical for effective program management and Contractor performance evaluation.

Management Reports of previous month activity should be submitted NLT 15th of the following month.

100% completion of service reports related to equipment under contract. To include UTL, PM completion percentage, Awaiting Parts, and Operator Errors.

COR shall monitor date of receipt and completeness of service reports.

5.11

Response time for corrective maintenance calls.

Telephone contact within 2 hours and…