Attachment 2 Performance Work Statement.pdf

Performance Work Statement: Medical Device Maintenance & Service (Naval Medical Center San Diego)

PERFORMANCE WORK STATEMENT

Medical Device Maintenance & Service

Navy Medicine Readiness and Training Command – San Diego (NMRTCSD)

UID: 00259173861

1.0. GENERAL INFORMATION

1.1. General. Navy Medicine Readiness and Training Command – San Diego (NMRTCSD) has a requirement for a non-personal services contract to maintain designated, Government-owned sterilizers, washers, operating room tables, surgical sinks, and warming units, manufactured by Steris Corporation and/or their subsidiary companies. Attachment 1 references the full equipment list. Maintenance and support shall be provided for a one (1) year period of performance spanning 01 March 2022 through 28 February 2023, including four (4) subsequent option years. The selected vendor must be able to provide support immediately upon award of a resulting order.

1.2. 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.

1.2.1. The firm fixed-price (FFP) maintenance agreement 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 full equipment list. 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.

1.2.2. When product recalls or updates are necessary to maintain the contractual equipment inventory within the

OEM’s specifications, the Contractor shall obtain and install the necessary updates.

1.2.3. The amount of equipment covered under the contract may 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.

1.2.4. This contract shall provide scheduled and unscheduled support/service coverage between the hours of 0700 and 1700 (Pacific Time), Monday through Friday, 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.

1.3. Government Points of Contact.

Technical Representative:

Jesse Bell Naval Medical Center San Diego Phone: 619-532-8059 E-mail: jesse.a.bell2.civ@mail.mil

Alternate Technical Representative:

LS2 Joelking Laudato Naval Medical Center San Diego

Phone: 619-532-8010 E-mail: joelking.b.laudato.mil@mail.mil

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

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

2.2. 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.

2.3. Contractor Performance Assessment Reporting System (CPARS): Web enabled application that collects and manages the library of automated CPARs.

2.4. 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.

2.5. 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.

2.6. 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 3.9.2.

2.7. 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.

2.8. 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.

2.9. 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)

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

2.11. 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).

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

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

2.14. 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.

2.15. 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.

2.16. 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 and/or ISO 13485 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 Technical Representative and to the Biomedical Equipment/Engineering Department (BIOMED) 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. The Contractor must verify that an individual whom they plan to employ or continue to employ in the United States is authorized to accept employment in the United States. Individuals such as those who have been admitted as permanent residents, granted asylum or refugee status, or admitted in work-related nonimmigrant classifications may have employment authorization as a direct result of their immigration status.

3.1.1. Field Service Engineers (FSEs) 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 KO and the Technical Representative, written assurance of the competency of their personnel as well as a list of credentials of approved Field Service Engineers. The KO and/or Technical Representative 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: NMRTCSD reserves the right to reject any of the service vendor’s personnel and refuse them permission to enter the premises or work on NMRTCSD equipment. This right may be exercised at any time. The reasons for rejections may include: lack of training and experience, but may also include, but not be limited to: behavior, attire, security concerns, and immigration status.

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

3.1.1.5. Field Service 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 deemed beneficial in expediting 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, can administer corrective responses to all 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. Test equipment requirements are further outlined in Section 3.11.

3.1.4. In order to travel freely onto and off of the military installation at NMRTC Dental Clinic locations, Field Service Engineers may have to undergo National Agency Checks, Local Agency Checks, other background checks, the Defense Biometric Identification System (DBIDS) process, or similar processes.

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 ensure that 100% of all periodic maintenance is performed no later than the 15th of the month in which maintenance is required. 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 Technical Representative.

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 Technical Representative. Contractor shall arrange the performance via coordination with the Technical representative 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 Technical Representative may determine that the property has been disposed of or is otherwise inactive or unavailable for use and adjust Attachment 1, accordingly.

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 Attachment 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 Technical Representative 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, Technical Representative, KO, and BIOMED.

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

3.2.4. Under the circumstances of 3.2.1 or 3.2.2, the Technical Representative 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 Attachment 1 via official contract modification.

3.3. Corrective maintenance: The Contractor shall provide for any corrective maintenance services necessary to maintain equipment within the OEM’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 OEM’s specifications, and shall make no modifications to the original design.

3.3.3. Repair by exchange: All “repair by exchange” shall be approved in advance by the Technical Representative. In the event that items/sub-assemblies/accessories are repaired via “repair by exchange”, a detailed description of replaced items is to be included upon return of repaired components.

3.3.4. Response time: Within four (4) hours of notification by NMRTCSD BIOMED, the Contractor and/or its representatives 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 twenty-four (24) hours to complete the requested service or repair. 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 0700-1700 Pacific Time support hours.

3.3.5. Telephone Support: Telephone consultation shall provide instructions on diagnosing common issues, those created by operator error or otherwise. Telephone consultation shall also assist in determining the most likely cause of the problem and if the problem resolution will likely require the dispatch of a FSE or ordering of OEM new, non-refurbished parts.

3.3.6. 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 by 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: No overtime services shall be completed without appropriate modification to the contract as executed by the KO. Work determined to be outside the scope of this contract should be communicated to the KO and Technical Representative.

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 Attachment 1, within the parameters of the OEM’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 three (3) business days.

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. Biomedical Equipment Technician (BMET) Training: The Contractor shall provide one initial training session for all NMRTCSD 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 Technical Representative, the Contractor shall provide additional training sessions during the contract period, as required.

3.8. 100% Completion During Hours of Work: Work required in the performance of this contract shall be performed Monday through Friday, 0700 – 1700 (Pacific Time), excluding United States Federal Government holidays. https://www.opm.gov/policy-data-oversight/pay-leave/federal-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 Technical Representative 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.

3.9.2. 95% Service Event Documentation: Within 72 hours of 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

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

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

9. Resolution and/or pending action(s)

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

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

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

11. Signatures:

a. Contractor performing service

b. BMET verifying service rendered

3.10. 100% Monthly Reports: The Contractor shall submit monthly management reports on the maintenance and repair activity of all equipment under this contract to the Technical Representative 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 Technical Representative, 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 NMRTCSD Dental Clinic 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 Technical

Representative, duty BMET, and Command Equipment Manager. Security/property passes for equipment removal shall be obtained by the Contractor personnel via the Materials Management Department. 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 Navy Medicine equipment control number (ECN) of all equipment or items removed.

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, NMRTCSD.

3.12.3. Hard Disk and Solid State Drives (HDD & SSD): In regards to patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing patient information from the NMRTCSD. HDD and SSD shall never be removed from the MTF by the Contractor under this maintenance agreement. Removal of protected health information (PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the Technical Representative and Command Equipment Manager.

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.

3.12.5. Uptime: Equipment shall be returned to operational condition within 72 hours after telephone notification from BIOMED.

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

3.12.7. Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance experience at NMRTCSD, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations, listed below, 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 1.2.4. & 3.13.1.):

H1= 0800 hours H2= 1600 hours A= 5 days per week W= 52 weeks per year C = 95%

Calculations:

𝐻 = 𝐻2 − 𝐻1

1600 − 0800

= 8 𝐻𝑜𝑢𝑟𝑠 𝑜𝑓 𝐶𝑜𝑣𝑒𝑟𝑎𝑔𝑒 𝑝𝑒𝑟 𝑑𝑎𝑦

𝑈 = 𝐻 ∗ 𝐴 ∗ 𝑊 = 8 ∗ 5 ∗ 52 = 2,080 𝐻𝑜𝑢𝑟𝑠 𝑜𝑓 𝑃𝑜𝑠𝑠𝑖𝑏𝑙𝑒 𝐸𝑞𝑢𝑖𝑝𝑚𝑒𝑛𝑡 𝑈𝑝𝑡𝑖𝑚𝑒

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

𝑇 = 𝑈 − 𝐷

𝑈

2080 − 𝐷

∆= (𝐶 − 𝑇) ∗ 100 = (. 95 − 𝑇) ∗ 100

*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.

3.12.8. 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 KO and Technical Representative prior to this equipment’s commercial end of service life (EOSL). This notice shall be delivered within 30 days of discovery, in writing on the Vendor’s letterhead.

3.12.9. 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.

3.12.10. 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 KO and Technical Representative 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 Technical Representative 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. NMRTCSD 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 KO 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 Engineers shall wear visible photo identification at all times while on the premises of the MTF. It is the responsibility of the Field Service Engineers to park in the appropriate designated parking areas. Information on parking is available from NMRTCSD 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. PERFORMANCE REQUIREMENTS SUMMARY (PRS)

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.

100% of all periodic, preventive maintenance is performed within 30 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.

Address total preventive and corrective maintenance work orders generated, numbers completed as a percentage, and numbers outstanding at the end of each month.

Monthly management reports on the maintenance and repair activity of all equipment under this contract.

100% monthly management reports on the maintenance and repair activity of all equipment under contract submitted no later than the fifteenth

(15th) day of the month.

COR shall review monthly management report completeness and date of receipt.

3.10

Response time for corrective maintenance calls.

Telephone contact within 4 hours and on-site within 24 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.

3.3.4.

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

Equipment listed in Technical

Exhibit 1 shall be fully functional.

Contractor is expected to return the device to service within 72 hours.

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 Engineers must submit a signed service report to the

COR or Biomed.

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.

1.2.4., 3.3.4., 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 NMRTCSD that are designed to meet the requirements of The Joint Commission, when requested by the Technical Representative.

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 Technical Representative 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 (SOP). The Government reserves the right to establish and/or change SOPs 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. CONTRACTOR-FURNISHED ITEMS AND SERVICES:

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

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

10.3. 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.

10.4. The Contractors personnel shall comply with all applicable DoD, DHA, and/or Navy Information Assurance and

Cybersecurity Policies.

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

11. GOVERNMENT-FURNISHED ITEMS AND SERVICES:

11.1. 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.

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

11.3. Two-way Radios & Cell Phones. The use of Contractor provided two-way radios and cell phones for communication between personnel must be approved by the Base Communications activity and may not be used in designated areas in NMRTCSD and its Dental Clinic locations. Contractor shall submit a written request to use the radios to the Technical Representative. 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. Contractors are required to maintain a Drug Free Workplace, as well as to require any sub-Contractors to do the same.

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.

13.2.4. Ensure that all Contractor personnel receive DoD IA training before being granted access to DoD AISs.

14. TECHNICAL EXHIBIT 1: EQUIPMENT LIST

See attached Excel document titled “Attachment 1_Equipment List”

Enclosures:

Enclosure 1 - Contract Discrepancy Report Enclosure 2 - Contractor Performance Assessment Report Enclosure 3 – Technical Representative Monthly Report to the Contracting Officer

Enclosure 1 - Contract Discrepancy Report

CONTRACT DISCREPANCY REPORT

Contract Number: Contract Clause: Date:

Technical Representative Findings:

Technical Representative (sign and date):

Contractor Response:

Contractor Project Manager (sign and date):

Technical Representative Determination/Recommendation:

Technical Representative (sign and date):

Contracting Officer Acknowledgement and Recommendation (sign and date):

Enclosure 2 – Contractor Performance Assessment Report

CONTRACTOR PERFORMANCE ASSESSMENT REPORT

Contractor Name and Address:

Company Name:

Street Address:

Report Type: {Annual or Final or Addendum}

Period of Performance Being Assessed:

Contract Number:

Order Number:

Location of Contract Performance:

Program Title:

Contract Effort Description:

Key SubContractor(s):

Contractor Name:

Effort Performed:

Contractor Name:

Effort Performed:

Evaluation Ratings Definitions (Excluding Utilization of Small Business) Rating Definition Note

Exceptional Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the Contractor was highly effective.

To justify an Exceptional rating, identify multiple significant events and state how they were of benefit to the Government. A singular benefit, however, could be of such magnitude that it alone constitutes an Exceptional rating. Also, there should have been NO significant weaknesses identified.

Very Good Performance meets contractual requirements and exceeds some to the Government’s benefit. The

To justify a Very Good rating, identify a significant event and state how it was a benefit to the contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the Contractor was effective.

Government. There should have been no significant weaknesses identified.

Satisfactory Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the Contractor appear or were satisfactory.

To justify a Satisfactory rating, there should have been only minor problems, or major problems the Contractor recovered from without impact to the contract. There should have been NO significant weaknesses identified. A fundamental principle of assigning ratings is that Contractors will not be assessed a rating lower than Satisfactory solely for not performing beyond the requirements of the contract.

Marginal Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the Contractor has not yet identified corrective actions. The Contractor’s proposed actions appear only marginally effective or were not fully implemented.

To justify Marginal performance, identify a significant event in each category that the Contractor had trouble overcoming and state how it impacted the Government. A Marginal rating should be supported by referencing the management tool that notified the Contractor of the contractual deficiency (e.g., management, quality, safety, or environmental deficiency report or letter).

Unsatisfactory Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element contains a serious problem(s) for which the Contractor’s corrective actions appear or were ineffective.

To justify an Unsatisfactory rating, identify multiple significant events in each category that the Contractor had trouble overcoming and state how it impacted the Government. A singular problem, however, could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tools used to notify the Contractor of the contractual deficiencies (e.g., management, quality, safety, or environmental deficiency reports, or letters).

Evaluation Ratings Definitions (Utilization of Small Business)

Rating Definition Note Exceptional Exceeded all negotiated subcontracting goals or exceeded at least one goal and met all of the other negotiated subcontracting goals for the current period. Had

To justify an Exceptional rating, identify multiple significant events and state how they were a benefit to small business utilization. A singular benefit, however, could be exceptional success with initiatives to assist, promote, and utilize small business (SB), small disadvantaged business (SDB), women-owned small business (WOSB), HUBZone small business, veteran-owned small business (VOSB) and service disabled veteran owned small business (SDVOSB). Complied with FAR 52.219-8, Utilization of Small Business Concerns.

Exceeded any other small business participation requirements incorporated in the contract, including the use of small businesses in mission critical aspects of the program. Went above and beyond the required elements of the subcontracting plan and other small business requirements of the contract. Completed and submitted Individual Subcontract Reports and/or Summary Subcontract Reports in an accurate and timely manner.

of such magnitude that it constitutes an Exceptional rating. Ensure that small businesses are given meaningful, innovative work directly related to the project, rather than peripheral work, such as cleaning offices, supplies, landscaping, etc. Also, there should have been no significant weaknesses identified.

Very Good Met all of the negotiated subcontracting goals in the traditional socio-economic…