Attachment 1 PWS- Leica CS Revisions final.pdf

Performance Work Statement: Medical Device Maintenance & Service NMC Portsmouth

PERFORMANCE WORK STATEMENT

Maintenance & On-site Support

Naval Medical Center Portsmouth N00183

1.0. GENERAL INFORMATION

General. Naval Medical Center Portsmouth N00183 has a requirement for a non‐personal service and maintenance contract for designated, Government-owned Leica Microsystems Inc. microscopes, light, examination, microscopes, light, operation, otorhinolaryngology, and microscopes, light, operating, according to this Performance Work Statement. Technical Exhibit 1 references the full equipment list.

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

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

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

1.1.3. The aggregate amount of equipment covered under the contract shall fluctuate over time, as hardware and software eclipse useful life and as new equipment comes off warranty. However, the aggregate requirement and level of effort will remain relatively constant over the life of the contract. Any changes to the equipment list will be executed through an official contract modification.

1.1.4. This contract shall provide unscheduled support/service coverage 0800 – 1700 (Local Time), Monday through Friday, unless otherwise specified in the equipment listing in Technical Exhibit 1, excluding

United States Federal Government holidays, which 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.

1.1.5. Government Points of Contact.

Contracting Officer’s Representative:

Francisco Abano

BMET

NMC Portsmouth

54 Lewis Minor St, Bldg 250

Portsmouth, VA 21708

(757) 953-5336

Francisco.v.abano.civ@mail.mil

Technical Liaisons:

HM1 Steven Sewell

BMET

NMC Portsmouth

54 Lewis Minor St, Bldg 250

Portsmouth, VA 21708

(757) 953-5336 steven.sewell2.mil@mail.mil https://www.jointcommission.org/ https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay

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

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

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

2.3. Contracting Officer (KO). A warranted representative of the federal government, who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

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

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

2.5. Contractor Performance Assessment Reporting System (CPARS). Web enabled application that collects and manages the library of automated vendor performance reports.

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

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

2.8. Field Service Report (FSR). Documentation completed by vendor personnel to officially record all instances of contracted troubleshooting, work, and services conducted on equipment. Specifics on required reporting details can be seen in Section 3.7.2.

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

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

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

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

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

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

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

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

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

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

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

3. PERFORMANCE REQUIREMENTS: The Contractor shall provide equipment maintenance services to include all periodic planned maintenance and unscheduled repairs, in accordance with OEM specifications and in compliance with ISO 9001 standards, to include repairs necessitated by operator error. Upon completion of each preventive maintenance visit and each corrective maintenance visit, Field Service Engineers must submit a signed service report, in English, to the COR and Biomedical Equipment Technician (BMET) Technical Liaison

(TL) for data entry into DMLSS. The service report shall include all information outlined in Section 3.9.2 of the contract.

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

3.1.1. Field Service Engineers (Engineers) shall be authorized by the OEM-certified service vendor to perform the required maintenance services. The Contractor shall ensure that all field engineers possess current

OEM-certification level training on all devices encompassed in the equipment list. Field Service Engineers shall have sufficient experience to demonstrate proficiency in maintenance of the Government-owned product(s).

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

3.1.1.2. 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 Engineers. The KO and/or COR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

3.1.1.3. Government Right of Refusal: Naval Medical Center Portsmouth N00183 reserves the right to reject any of the service vendor’s personnel and refuse them permission to enter the premises or work on Naval

Medical Center Portsmouth N00183 equipment. This right may be exercised at any time. The reasons for rejections may include: lack of training and experience, but may also include, but not be limited to:

behavior, attire, security concerns, and immigration status.

3.1.1.4. Reserved

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

3.1.2. Technical documentation: The Contractor shall obtain, have on file, and make available to its Field

Service Engineers all operational and technical documentation, which is required to meet the performance requirements of this contract. This documentation shall include any software needed or beneficial in speeding the diagnosis, repair, or calibration of the equipment, equivalent to that used by the OEM to perform the same work. The Contractor shall ensure that all Field Service Engineers possess the ability to perform corrective software updates/upgrades and OEM or FDA recall notices, and are in possession of legally licensed diagnostic software necessary for rapid, efficient, and effective maintenance.

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

3.1.4. In order to travel freely onto and off of the military installation at Naval Medical Center Portsmouth

N00183, Field Service Engineers may have to undergo background checks, the Rapid Gate process, the

Defense Biometric Identification System (DBIDS) process, or a similar process.

3.1.5. The Contractor Point of Contact (POC): The Contractor shall provide, in writing, the name and telephone number of a primary and alternate, English-speaking, individual to act as their representative for the scheduling and coordination of service calls.

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

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

3.2.2. Equipment Unable to Locate (UTL). If the Contractor is unable to locate an item within the maintenance window specified, the Contractor shall immediately notify the COR. Contractor shall arrange the performance via coordination with the Contracting Officer’s Representative (COR) or Technical Liaison

(TL) during circumstances of unexpected delays (i.e. non-availability of the patient care areas due to room occupancy, etc.), at no additional cost to the Government. The COR may determine that the property has been disposed of or is otherwise inactive or unavailable for use and adjust Technical Exhibit 1, accordingly.

This information shall then be provided to NMLC Maintenance Engineer and KO for appropriate modification of the agreement.

3.2.3. Preventive Maintenance Scheduling: The Contractor shall schedule service vendor preventive maintenance visits as specified for each equipment item. For all equipment listed in Technical Exhibit 1, the frequency of preventive maintenance will be determined by the DMLSS property database, dependent on device codes, unless the OEM PM (preventive maintenance) periodicity is more frequent. The

Contractor will coordinate with BIOMED and/or the TL to ensure the preventive maintenance completion month(s) are aligned with the due date(s) for each device set forth in DMLSS. The schedule is to be documented at the beginning of the contract period with a copy provided to the Contractor, COR, TL, and

BIOMED.

3.2.3.1. Preventive maintenance visits shall be scheduled with the Naval Medical Center Portsmouth N00183

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

3.2.4. 100% Preventive Maintenance: Under the circumstances of 3.2.1 or 3.2.2, the COR and Contractor shall arrange a means of complying with the requirements for preventive maintenance at no additional cost to the

Government. Equipment determined missing, lost, or stolen shall be removed from Technical Exhibit 1 via official contract modification.

3.2.5. Off-site Preventative Maintenance: Some equipment or devices may require that preventative maintenance be completed outside of the MTF. In this case, the contractor shall still follow all procedures set forth by this agreement. No equipment shall be removed without the approval of the COR, duty BMET, and Command Equipment Manager. Preventive maintenance visits shall be scheduled with the Biomedical

Engineering Department 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, so as to not require rescheduling patients.

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

Government-owned equipment.

3.3. Corrective maintenance: The Contractor shall provide for any corrective maintenance services necessary to maintain equipment within the original manufacturer’s specifications, and in accordance with any applicable

FDA and/or Joint Commission requirements. Corrective maintenance shall include repairs for all listed equipment to include problems resulting from, but not limited to, unintentional damage, operator error, normal wear and tear, component part failures, environmental issues (e.g., water damage), etc.

3.3.1. The Contractor will not accept any trouble calls other than through BIOMED. Contractor trouble call intake from BIOMED shall include a work order number, indicating that the equipment failure and service needed is properly recorded and included in the equipment’s maintenance history.

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

3.3.3. Repair by exchange: If any Microscopes, listed in Technical Exhibit 1, cannot be repaired or maintained for clinical use, the endoscope(s) shall be replaced. Replacement(s) shall be sent to Naval Medical Center

Porthsmouth N00183 within 8 business hours of endoscope damage disposition. Replacement(s) must be the exact same part/model number, generation, and image quality of equipment as the previous endoscope prior to its damage. Contractor must provide unlimited replacement quantities for Microscopes, listed in

Technical Exhibit 1.

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

3.3.5. Response time: Within one (1) hour of notification by the Naval Medical Center Portsmouth N00183

BIOMED, Contractor technical personnel shall respond by telephone. If the equipment cannot be restored to the operating condition via telephone technical support, the Contractor personnel shall arrive onsite within eight (8) business hours as noted below, to complete the requested service, repair, or provide a replacement (Microscopes). The onsite response time is measured from the time the Contractor is originally called, not from the time the Contractor returns the call. On-site responses will only be rendered under this contract during the 0800-1700 local time support hours.

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

3.3.7. Software maintenance is within the scope of the contract, including updates and patches as needed, at no additional cost to the Government. The Contractor shall provide software revisions and updates, via field service changes, as required by the FDA or manufacturer announced safety-hazard recalls. Updates shall be performed as soon as possible after release, no later than the first scheduled Preventative Maintenance

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

3.4. Overtime: Overtime shall not be billed to the Government.

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

3.6. Parts: The Contractor shall provide coverage for all repair and replacement parts necessary to maintain the equipment, listed in Technical Exhibit 1, within the parameters of the original manufacturer’s specifications.

The Contractor shall supply new, non-refurbished OEM parts, lubricants, and lubricant wear points for all repairs. Contractor installed replacement parts shall become the property of the Government. The Contractor shall extend to the Government all commercial warranties on replacement parts, consistent with standard industry practices. Replaced items shall be properly disposed of at no additional cost to the Government

(Contractor shall pay all “environmental fees”, where required). Replacement parts shall be furnished within one (1) business day. Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts, shall be the responsibility of the Contractor.

3.7. BMET Training: The Contractor shall provide one initial training session for the all MTF BIOMED personnel on the procedures and processes of the Contractor’s maintenance program, immediately upon contract award.

This training will provide the BMETs with insight into the OEM specified procedures for preventative maintenance and frequently observed issues that require corrective maintenance. When requested by the COR, the Contractor shall provide additional training sessions during the contract period, as required.

3.8. 100 % Completion During Hours of Work: Onsite Work required in the performance of this contract shall be performed Monday through Friday, 0800 – 1700 (Local Time), excluding United States Federal Government holidays. The Contractor shall also provide a telephone consulting service, twenty-four (24) hours per day, seven (7) days a week. This telephone consulting service shall be provided to avoid undue delays in contract service coverage during after-hours and weekend/holiday periods, as applicable. Under no circumstances shall the Contractor assume an inquiry, via telephone or any other means, is authorization to provide services not specifically covered by the terms of the contract.

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

3.9.1. Lock Out/Tag Out: The Contractor shall personally notify BIOMED, via FSR, of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment (i.e., Lockout, removal to BIOMED) shall be implemented in compliance with Occupational Safety and Health Administration (OSHA) and Navy regulations, specifically Title 29 1910.147 of the Code of Federal Regulations and the OPNAVINST 5100.23G Chapter

24, to prevent any patient, staff, or visitor hazards. Where lockout procedures are not possible, tag-out procedures shall be followed in accordance with the above regulations. Additionally, a label shall be adhered to the disabled equipment specifying the equipment is not serviceable. Reference (i) is available at: http://www.public.navy.mil/NAVSAFECEN/Documents/OSH/SafetyOfficer/5100.23G_CH-

1_with_updated_links.pdf . Naval Medical Center Portsmouth BIOMED will assist with this Lock Out/Tag

Out effort, as long as they are made aware prior to the Contractor leaving the MTF.

3.9.2. Service Event Documentation: Upon completion of each preventive maintenance visit and each corrective maintenance visit, Field Service Engineers must submit a signed Field Service Report (FSR) to BIOMED.

The service report shall indicate all problems addressed, devices checked, parts replaced/repaired, parts ordered, and problem resolution or pending action. Each service report must at a minimum document the following data legibly, in English, and in complete detail:

1. Name of Contractor

2. Name of Contractor personnel performing service

3. Contractor personnel log/control number

4. Equipment identification factors to include: Manufacturer, make, model, serial number and

Facility Equipment Control Number (ECN)

5. Description of problem reported by user

6. Date & time of initial trouble call http://www.public.navy.mil/NAVSAFECEN/Documents/OSH/SafetyOfficer/5100.23G_CH-1_with_updated_links.pdf http://www.public.navy.mil/NAVSAFECEN/Documents/OSH/SafetyOfficer/5100.23G_CH-1_with_updated_links.pdf

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

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

Medical Treatment Facility (MTF) personnel

9. Resolution and/or pending action(s)

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

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

b. Note - This pricing information is not to be confused with an invoice and no separate payments will be made for the services provided. This is a firm fixed price contract, meaning the contract will be reimbursed at an agreed upon monthly rate regardless of the amount of work performed each month.

11. Signatures:

a. Contractor performing service

b. BMET verifying service rendered

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

3.11. Test equipment: The Contractor will ensure that all test equipment and/or calibration standards, which are to be used in the performance of this contract, are traceable and certified in accordance with National Institute of Standards and Technology (NIST). Any efforts conducted without equipment within the calibration intervals is not performance in accordance with this contract. Upon request by COR, the Contractor 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 MTF equipment. In the event the test equipment and/or calibration standards are calibrated/certified throughout the course of this contract, the latest calibration/certification documentation must be submitted to BIOMED.

3.12. Removal of equipment from site: No equipment shall be removed without the approval of the COR, duty

BMET, and Command Equipment Manager. Security/property passes for equipment removal shall be obtained by the Contractor personnel via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of service Contractor personnel are the sole responsibility of the service Contractor personnel.

3.12.1. Removal Report: The Contractor shall provide a detailed description of removed items in writing on the

Contractor’s company letterhead. For associated items/accessories, Contractor shall provide a detailed written description and quantities of items to be removed. The description will include, as a minimum, manufacturer’s serial numbers and equipment control number (ECN) of all equipment / items removed. In the event that items/sub-assemblies/accessories are repaired via “Repair by Replacement”, a detailed description of replaced items is to be included upon return of repaired components.

3.12.2. Off-site repairs: No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a Contractor determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the

Contractor. The Contractor shall provide insurance coverage for damage to or loss of equipment while in

Contractor or service Contractor’s custody. The Contractor will provide alternate, interim loaned unit(s) for any equipment requiring repairs outside of the Materials Management Department, BIOMED, Naval

Hospital Jacksonville.

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

Contractor under this maintenance agreement.

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

3.13. Uptime: Equipment shall be returned to operational condition within 24 hours after telephone notification from BIOMED.

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

3.13.2. Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance experience at Naval Medical Center Portsmouth N00183, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations may be used to compute these metrics.

Variables Definitions:

U= Possible Equipment Uptime (100%)

H= Hours of Coverage per day

H1= Begin Coverage Time during each day

H2= End Coverage Time during each day

A= # of covered days of the week

W = Weeks of Coverage in a Year

C= Uptime Commitment (per Section 3.13.1.)

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

H1= 0800 hours

H2= 1700 hours

A= 5 days per week

W= 52 weeks per year

C = 95%

Calculations:

D= Hours of Calculated Downtime (Unknown)

T= Total Actual Uptime Percentage (Unknown)

Δ= % difference from Uptime Commitment (Unknown)

*Note* - Downtime hours shall fall within the Contractor’s hours of coverage listed in Section 1.2.4.

Downtime hours outside of the coverage timeframe listed in Section 1.2.4. shall not be calculated as a metric of vendor performance. Downtime ends once the system is available for full clinical use.

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

Mario.c.brito.civ@mail.mil; keith.w.watford.civ@mail.mil mailto:Mario.c.brito.civ@mail.mil

3.14.1. This specific contract deliverable shall supplement, but not supersede, any existing, external ‘End of

Service Life Notification’ requirements, as set forth by other Government agencies, such as the Food &

Drug Administration (FDA) or the Joint Commission.

3.14.2. Delivery of this letter shall not immediately remove the vendor’s liability of covering the equipment under the terms and conditions of this contract. Its delivery shall simply be a means to start a dialogue with the

COR and Naval Medical Center Portsmouth N00183 about the parameters associated with the commercial

EOSL for the specific make/model of medical equipment.

4. SAFETY REQUIREMENTS: The Contractor shall take safety precautions as the COR or his/her designee may determine to be reasonably necessary to protect the lives and health of occupants of buildings in which work is being performed. The MTF shall notify the Contractor of any non-compliance with the foregoing conditions and the action(s) to be taken. Service vendors shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. If a field service engineer refuses to comply promptly, the

COR may issue an order stopping all or any part of the work. Under such circumstances, the KO can hold the service vendor in contract default. Nothing in this section shall be construed so as to limit the Contractor responsibilities to comply with any existing law, nor to switch jurisdictions.

5. IDENTIFICATION, PARKING, SMOKING MTF REGULATIONS: Field service personnel shall wear visible photo identification at all times while on the premises of the MTF. It is the responsibility of the field service personnel to park in the appropriate designated parking areas. Information on parking is available from

MTF Security personnel. Smoking is strictly prohibited inside any buildings of the MTF. Possession of weapons, alcohol, or pharmaceuticals that are not over the counter and not prescribed to the individual/family is prohibited on the MTF premises. Enclosed containers, including tool kits, are subject to search. Violations of

MTF regulations may result in citation answerable in the United States (Federal) District Court. Violation of any policy which results in lost time for Contractor is the sole responsibility of the Contractor, and shall not be charged to the government.

6. GENERAL LIABILITY INSURANCE: The Contractor shall be required to have liability insurance to cover any actions on the part of the field engineers which result in injury or death to patients, staff, visitors, or other

Contractors. Such comprehensive form of policy shall provide coverage of at least $500,000 per occurrence

(FAR 28.307-2).

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

Liability coverage of at least $500,000.

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

9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Performance

Objective

Performance

Standard

Acceptable

Quality Level

Monitoring

Method/Performance

Assessment

PWS

Reference

Medical equipment essential to the healthcare delivery mission is properly maintained ensuring a safe environment of care for patients 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.

3.2

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.

95% 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.

3.9.2, 3.10

Response time for corrective maintenance calls.

Telephone contact within 1 hour and on-site within 2 hours.

Contractor shall be compliant 95% of the time for both telephone and on-site responses.

COR shall review log of calls and verify response times via DMLSS documentation.

3.3.5

Equipment critical to healthcare delivery is operational and available for use as required.

Equipment listed in Technical

Exhibit 1 shall be fully functional, or else it should be replaced.

Contractor is expected to return the device to service within 48 hours from the time the Contractor was contacted

COR shall review DMLSS data for compliance.

3.13

Equipment post-service event status Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel must submit a signed service report to the

COR.

Contractor shall be compliant 95% of the time for providing signed service report to COR.

COR shall review DMLSS data, service log and service reports for compliance.

3.9.2

All work to be completed during normal work hours.

No work outside of established work hours.

100% completion of work during normal work hours.

COR shall review DMLSS data, service log and service reports for compliance.

3.8

9.1. Compliance with Applicable Laws: Contractor shall be knowledgeable of and comply with all applicable

Federal, State, and local laws, regulations, and requirements regarding the conduct of his business.

9.2. Site Visits. The Government reserves the right to schedule meetings to discuss or resolve issues/problems, as it deems to be critical, at no additional cost to the Government. Contractor personnel shall participate in activities of NMC Portsmouth that are designed to meet the requirements of The Joint Commission, when requested by the COR or TL.

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

Government under this contract.

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

9.5. Phase-In Service: Upon award, which should occur prior to expiration of existing service contracts, the

Contractor shall have the opportunity to inspect the existing equipment and note any deficiencies. This action shall occur in sufficient time to notify the existing contract holder to correct deficiencies noted (at least 24 business hours prior to expiration of contract). Failure to submit such list in a timely manner shall be considered acceptance of the equipment in the existing condition, which means that the Contractor shall not be eligible to claim expenses to bring the equipment up to manufacturers’ specifications.

9.6. Phase Out of Service: Upon expiration or termination of this contract, the Contractor, at the Contractors’ expense, shall provide OEM certifications for all equipment covered under contract at the rates/discounts normally provided to Government customers. If repairs or corrections to the equipment have to be made to obtain such certifications, the contract shall arrange to have those repairs or corrections made at the

Contractors’ expense.

10. GOVERNMENT-FURNISHED PROPERTY AND SERVICES.

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

10.2. Physical Security. The Contractor shall safeguard all Government property provided for Contractor use.

The Contractor shall designate an individual and alternate(s) to receipt and account for Government-furnished facilities and equipment.

11. CONTRACTOR-FURNISHED ITEMS AND SERVICES.

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

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

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

11.4. Two-way Radios & Cell Phones. 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.

12. OCCUPATIONAL HEALTH.

12.1. Occupational Health/Immunizations: The Contractor personnel shall be immunized annually with the influenza vaccine with the Contractor bearing the total cost. On an annual basis, Contractor shall provide a current Purified Protein Derivative (PPD) reading or an evaluation if they are a known PPD reactor. The

Contractor is responsible for any expenses incurred for required testing.

13. PERSONNEL SECURITY.

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

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

13.2. Government Requirements for Background Checks: The Contractor shall comply with DoDD 8500.1, “Information Assurance (IA)”, DoD Instruction (DODI) 8500.2 “Information Assurance (IA) Implementation”, DoDD 5400.11, “DoD Privacy Program”, DoD 6025.18-R, DoD Health Information Privacy Regulation and

DoD 5200.2-R, “Personnel Security Program Requirements”. Contractor responsibilities for ensuring personnel security include, but are not limited to meeting the following requirements: Follow the Privacy Office guidelines for submittal of IT security clearances and ensure all Contractor personnel are designated as IT-I, IT-

II or IT-III where their duties meet the criteria of the position sensitivity designations.

13.2.1. Because of the unique circumstances presented by DoD and DON networks, personnel security requirements shall be followed to ensure appropriate precautions are taken prior to allowing Contractor personnel access to the network. Any Contractor personnel that will be accessing the medical device/system while installed on the hospital network will be required to have a National Agency Check

(NAC) completed. Typically, this requires an investigation to support a “Public Trust Position” and requires the person(s) to complete and submit a Standard Form 85P (SF85P), Questionnaire for Public

Trust Positions, via the Electronic Personnel Security Questionnaire (EPSQ). Questions relating to SF85Ps and the EPSQ process may be directed to 1-888-282-7682 or online at http://www.dss.mil/index.htm.

Contractor personnel accessing equipment connected to the hospital network will be required to complete a

System Authorization Access Request-Navy (SAAR-N) (form OPNAV 5239/14). Copies of this form can be obtained from the Naval Medical Logistics Command (NMLC), or the local MTF. Additionally, Contractor personnel are required to complete the annual DoD IA training requirements.

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

13.2.3. Immediately report to the appropriate Navy POC and deny access to any automated information system

(AIS), network, or information if a Contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate Navy representative for security reasons.

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

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

TECHNICAL EXHIBIT 1 - EQUIPMENT LIST See Attachment II

14. PREVENTIVE MAINTENANCE AND REPAIR SCHEDULES

14.1. Completed Field Service Reports are required prior to acceptance of any invoice.

14.2. Services shall be required based upon agreed schedules that meet the Navy and OEM specifications.

15. RISK MANAGEMENT FRAMEWORK (RMF)

15.1. Cybersecurity: The vendor shall establish appropriate administrative and technical safeguards to protect any and all data, to ensure the confidentiality, integrity, and availability of Government data under their control.

At a minimum, this shall include provisions for vendor personnel security and electronic security.

15.1.1. Support/conduct vulnerability mitigation to comply with cybersecurity controls listed in National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53; Security and Privacy Controls for

Federal Information Systems and Organizations and DHA Administrative Instruction 77.

15.1.2. The proposed system shall be capable of supporting the use of Defense Information Systems Agency

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

15.1.3. The vendor must provide their Antivirus (AV) policy and a list of AV Exceptions (if applicable) to the

NMLC prior to AV installation on the system/device. AV must be installed on all devices before they are placed on the Navy network.

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

15.2. Vulnerability Management: For products or systems which have received Authority to Operate (ATO) from DHA HIT, the vendor shall agree to be proactive in working with the Navy to mitigate new threats as they emerge, through the end of the ATO expiration date. Vulnerability mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected.

Operating systems, servers, development platforms and the application being delivered to the Navy shall be in compliance with all known applicable guidelines.

15.2.1. All vendor validated and approved patches, up to and including the date of install, must be loaded on the system prior to system go-live. Security scans will be run during Government acceptance testing. A CAT I vulnerability is any vulnerability, the exploitation of which will, directly and immediately result in loss of

Confidentiality, Availability, or Integrity. CAT II vulnerabilities are any vulnerability, the exploitation of which has a potential to result in loss of Confidentiality, Availability, or Integrity.

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

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

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

15.4.1. Contractors will connect to the B2B gateway via a Contractor procured Internet Service Provider (ISP) connection and assume all responsibilities for establishing and maintaining their connectivity to the B2B gateway. This will include acquiring and maintaining the circuit to the B2B gateway and acquiring a

Virtual Private Network (VPN) device compatible with the DHA VPN device. Maintenance and repair of

Contractor procured VPN equipment shall be the responsibility of the Contractor.

15.4.2. Contractors shall configure their network to support access to Government systems (e.g., configure ports and protocols for access).

15.4.3. Contractors shall provide full time connections to a TIER1 or TIER2 ISP.