PWS- For Main and Repair of Stealth 7_8_AxiEM.doc

PERFORMANCE WORK STATEMENT (PWS)

Maintenance and Repair Services This is a non-personnel services contract to provide the M&R services for the Stealth 7, 8 and AxiEM for the period: 1 Nov 2021 through 31 Oct 2022 (BASE) plus two option years for the Stealth 7, 8 and AxiEM and associated components located at Madigan Army Medical Center, Tacoma, Washington 98431.

EQUIPMENT LISTING

STEREOTACTIC SYSTEM, IMAGE GUIDED, SURGICAL, STEALTH 7

Dept. of Anesthesia & Operative Services

STEREOTACTIC SYSTEM, IMAGE GUIDED, SURGICAL, STEALTH 8

Dept. of Anesthesia & Operative Services

STEREOTACTIC SYSTEM, IMAGE- GUIDED, SURGICAL, INTRACRANIAL (AxiEm)

Dept. of Anesthesia & Operative Services

PERFORMANCE WORK STATEMENT

1. SCOPE OF WORK

The Contractor shall provide fully qualified technicians to perform the services for the Stealth 7, 8 and AxiEM as described herein to ensure that optimum operation and efficiency of the equipment is maintained, and that proper functioning of the equipment conforms to the Original Equipment Manufacturer (OEM) standard specifications. Contractor shall have knowledge of, furnish and install all OEM sponsored modifications at no additional charge. This includes all the OEM published Equipment Changed Orders (ECO) and Fielded Change Orders (FCO). Mandatory modifications include equipment upgrades or enhancements to equipment design, and changes necessary for operator and patient safety. In addition, the Government may request the Contractor to install said OEM sponsored modification in the event that the Government obtained knowledge of ECO or FCO before the contractor. Contractor will make all ECO and FCO modifications in a timely manner, but in no case shall it exceed sixty (60) calendar days after ECO or FCO is announced by the OEM. All such modifications shall be made so as not to interfere with the Government’s operation. If such modification is not possible during normal duty hours, the Contractor will do the modifications outside of normal duty hours (overtime) at no additional cost the Government

2. CONTRACTOR POINT OF CONTACT: The Contractor shall provide a single point of contact (POC) for any calibration services and repairs that is required:

NAME:

EMAIL:

TITLE:

TELEPHONE:

3. CONTRACTOR FURNISHED EQUIPMENT/MATERIALS: The Contractor shall provide any technical manuals, special tools, supplies, parts or test equipment that are required for the servicing of the Stealth 7, 8 and AxiEM. Upon request by the Government Point of Contact (GPOC) or Contracting Officer’s Representative (COR), the Contractor shall provide proof of calibration on test equipment used during services performed.

4. MAINTENANCE SERVICES/REPAIRS: The Contractor shall keep the system in good operating condition, meeting all published equipment requirements and standard specification listed by the OEM. In some cases including but not limited to: cleaning the system, checking the mechanical reliability and positioning accuracy, checking for potential problem components, performing a complete alignment that includes all the system potentiometers, and verification of electronic and hardware performance.(All the service will be required to have a Work Order created by Healthcare Technology Management Sustainment Technician)

4.1 Preventive Maintenance (PM): One (1), PM services shall be performed during the contract period. PM services shall include scheduled maintenance inspections, replacement of defective and worn parts, and testing service IAW OEM specifications. Services during the time frame will include one (1) electrical safety current leakage test to determine the amount of electrical current electrical leakage to the case of the unit. All services performed will be documented and indicated on the service report. The service reports will be given to the Clinical Engineering Branch for verification of contractor’s performance and approval of payment.

4.2 Calibration Service(s): One (1), Calibration Verification Check (CVC) will be performed for each contract period. The Contractor shall comply with the manufacturer’s specified frequency, duration and calibration procedures for the equipment listed above. Upon completion of the Calibration, the Contractor’s technician will complete the following items:

a. DD Form 2163 shall be affixed on the unit IAW the instructions in TB-38-750-2, paragraph 2-12.

b. DD Form 2164 (applicable for use with x-ray equipment only) IAW with the instructions in TB-38-750-c, paragraph 2-13, and a continuation sheet for DD Form 2164 listing the manufacturer, model, serial number and date of calibration. Required Department of Defense Forms or regulations may be furnished to the Contractor by the Government upon request.

4.3 CORRECTIVE MAINTENANCE:

a. The Contractor shall provide unlimited on-call technical support during standard hours of operation, 0700 – 1700 PST, Monday through Friday when notified by the Government Point of Contact (GPOC) or Contracting Officer’s Representative (COR) of equipment malfunction. Minimum standard response time is established as no later than the following workday after notification of equipment malfunction. During each service call, the Contractor shall take all steps to restore the equipment to proper operating conditions and replace components and parts determined by the Contractor’s technician to be defective.

b. All repairs shall be completed in a minimum amount of time, but not to exceed Two (2) working days. All maintenance actions that exceed Two (2) working days shall be reported to the COR and the Contractor’s technician shall provide a report that includes as a minimum the explanation for any maintenance delays and the estimated time to complete the repair.

c. Repairs required outside the scope of this contract are not authorized. Should acquisition of such services be deemed necessary by the Chief, Clinical Engineering Branch (CEB), a requisition shall be submitted to the Contracting Officer for negotiation under a separate contract.

d. Service vendor shall provide loaner equipment in the event equipment cannot be repaired. Additional cost of equipment replacement thereafter is the responsibility of the owner.

5. LOCATION OF SERVICES

5.1 On-site repairs are to be accomplished at Madigan Army Medical Center, JBLM. If work to be performed is too complex, or inappropriate to perform on-site, such work may be performed at local or factory repairs facilities with prior concurrence between the Chief, CEB. All preparation to necessitate such a move, packing, transportation, and reinstallation, shall be performed by the Contractor at no additional cost to the Government.

5.2 If the equipment is removed from the hospital for repair, the Contractor shall make a record of the fact and furnish a report to the Government Point of Contact (GPOC) or Contracting Officer’s Representative (COR) before removing the equipment with the following information as a minimum:

a. Date of removal.

b. Make, model, serial number, and Medical Materiel Control Number (MMCN).

c. Reason(s) for removal.

d. Contract number.

6. REPLACEMENT PARTS:

6.1 All parts, labor and travel to perform maintenance service and repairs (preventive or corrective) shall be included in the offered price, including (i.e., consumables, software updates, etc., that could affect price). Parts requiring replacement to maintain the equipment IAW manufacturer’s specifications and applicable regulations are to be replaced on a manufacturer's rebuilt or new part basis. Installation of government furnished parts and part(s) furnished by the Contractor shall be installed by the Contractor

6.2 Maintenance actions shall not be delayed by more than 24 hours due to the delivery of a repair part or item. All parts shall be new and shall meet OEM specifications.

7. MODIFICATIONS

7.1 The Contractor shall with the concurrence of the Contracting Officer or its representative, at no additional cost to the Government:

a. Make modifications to improve the operation or reliability of the equipment.

b. Implement any modification in circuitry or otherwise upgrade the equipment/system to effect current configuration to ensure optimum performance.

c. Make manufacturer recommended engineering changes that have been issued since MAMC’s acquisition of listed equipment or its components.

d. Provide all OEM and/or Food and Drug Administration (FDA) mandated software corrections and upgrades.

e. Provide the Chief, CEB, a complete copy of the schematics if there are any changes to the configuration or circuitry of the equipment or components as a result of modifications.

7.2 NOTE: No individual, including the Government Point of Contact (GPOC) or Contracting Officer’s Representative (COR), has the authority to approve modifications or changes that would result in an increase or decrease in the awarded contract price. This authority is vested with the Contracting Officer only, and will not be delegated. If a question as to whether the application of an equipment modification or change would result in a change to the contract price, the Contractor shall not commence work without the prior approval of the Contracting Officer.

8. iWATCH TRAINING. The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the typed of behavior to watch for and instruct employees to report suspicious activity to the Government Point of Contact (GPOC) or Contracting Officer’s Representative (COR). This training shall be completed within 30 calendar days of contract award and within 10 calendar days of new employees commencing performance with the results reported to the COR NLT 40 calendar days after contract award.

9. AT LEVEL 1 TRAINING. Contractor and all associated sub-contracts employees must successfully complete Army presented Level One Anti-Terrorism training within 30 days of the beginning of this contract. New employees must attend the training within 10 days of their reporting for duty. ACCESS and General Protection/Security Policy and Procedures. The contractor and all associated subcontractors employees shall comply with applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by the government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. The contractor shall comply with all personal identity verification requirements as directed by DoD, HQDA, and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes. Upon receipt of the awarded contract, the Contractor’s technician is responsible for reporting to the following locations:

9.1 Fort Lewis – Main Gate, I-5 exit 122 for vehicle pass and parking briefing (Required documents: Valid Driver’s license, vehicle registration and proof of insurance)

9.1.2 Madigan Army Medical Center

9.1.2.1 Clinical Engineering Branch (CEB): Upon entering or departing the Medical Center, the Contractor’s technician shall physically sign in and sign out with the CEB Service Desk, Building 9040A, Room G-16-4, during standard hours of operation 0700 and 1700, Monday through Friday, excluding federal holidays.

9.1.2.2 Provost Marshal Office, MAMC Medical Mall, 2nd Floor, Room 2-56-40: For access and general protection language/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

10. OPSEC Training. Per AR 530-1 Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

11. CONTRACTORS NOT REQUIRING COMMON ACCESS CARD (CAC) BUT REQUIRE ACCESS TO A DOD FACILITY OR INSTALLATION. The contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-111) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or at OCONUS locations, IAW the status of forces agreements and other theater regulations.

12. REPORTS: The Contractor shall provide the CEB a detailed itemized Service Report of all services performed and parts replaced upon completion of each repair or service. Report shall be delivered to the CEB Service Desk when signing out of the CEB. Services completed after standard hours, shall be faxed to CEB at (253) 968-1048. Minimum details for inclusion:

a. Make, model, serial number, and Medical Materiel Control Number (MMCN).

b. Malfunction and repairs performed.

c. Time in hours for repair(s) and technician’s hourly rate.

d. Part number and price of parts replaced.

e. Annotate either scheduled or emergency repair.

13. Safety and Health Plan - The contractor shall comply with Occupational Safety and Health Administration (OSHA) standards as a minimum level of safety and health performance and establish more stringent standards where necessary. The contractor shall comply with the requirements of MAMC, Army Safety Program "AR 385-10", "Department of Defense Instruction "DODI" 6055.1, and other applicable directives and regulations. The contractor shall report all accidents, incidents, mishaps, near misses and spills to the Government Point of Contact (GPOC) or Contracting Officer’s Representative (COR).

14. EXCLUSIONS

14.1 The Contractor is not responsible for maintenance service and repairs, or replacement parts, resulting from the fault or negligence of government personnel or acts of God. This Agreement specifically excludes labor, parts and expenses necessary to repair equipment.

14.2 The Contractor is not required to provide repair service between the hours of 1700 hours and 0700 hours weekday or on weekends and federal holidays. The Contractor may provide services during these times, with prior approval of the Contracting Officer Representative, at no additional cost to the Government. If additional costs are required for work outside normal working hours, a modification to the contract must be completed prior to commencing work.

15. INVOICING

15.1 Payment will be made in arrears [ ] Monthly [X] Quarterly [ ] Semi-Annually [ ] Annually. To be paid by Invoicing, Receipt, Acceptance and Property Transfer (iRAPT), WAWF.

15.2 The Government shall inspect all scheduled preventative and corrective maintenance, including reports resulting from the preventive and corrective maintenance. On-call corrective maintenance inspections will be performed periodically, as deemed necessary by the Contracting Officer Representative.

16. CONTRACTOR PERFORMANCE EVALUATIONS

a. In compliance with FAR Subpart 42.15, Contractor Performance Information, an evaluation of contractor performance will be conducted at contract completion. Interim performance evaluations will be conducted at least annually for contracts with a period of performance, including options, exceeding one year. As a minimum, the evaluation shall include the information in FAR 42.1501 “General”.

b. Each completed evaluation will be provided to the contractor. The contractor will have a minimum of 30 calendar days to submit comments, rebut statements, or add additional information.

c. Disagreements between the parties regarding the evaluation will be handled IAW FAR 42.1503 (b).

17. PERFORMANCE MEASURE REQUIREMENTS

a. Outcome. The contractor shall provide Madigan Army Medical Center’s Clinical Engineering Branch with service of the equipment listed above.

b. Standards. The standard of performance for the listed measures is 100% conformance to contract requirements.

c. How measured. Clinical Engineering Branch (CEB) personnel will monitor contractor performance by verifying service report documents upon completion of each repair or service.

18. PERFORMANCE REQUIRMEENT SUMMARY

Stealth System is required of annual Preventive Maintenance (PM) and Calibration services that includes unscheduled repairs with replacement part and labor during regular duty hours. Also Axiem service should be included for Stealth System.

Required Services

(Tasks) Performance

Standards Acceptable Quality

Levels Incentive (Positive and/or Negative)

(Impact on Contractor Payments)

Submit one service report for scheduled maintenance, (Para 4.1) Annual Calibration Verification Checks and Services for each contract period.

(Para 4.2)

Work Order is required per each service

(Para 4)

100% of reports accurately depict current status 100%, Cal should be perform at the same time with PM 100%, work order should be create per each service

100%

100% 100% Negative Report will be submitted to Contracting Officer Negative Report will be submitted to Contracting Officer Negative Report will be submitted to Contracting Officer

19. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

19.1. The purpose of this QASP is to provide a planned process for surveilling the contractor’s actual performance and comparing that performance against the contractual requirements to determine conformity IAW the Performance Work Statement (PWS). The policy of the Government for contractor quality control and Government quality assurance and applicable definitions are provided in the Federal Acquisition Regulations (FAR) in Part 46 Quality Assurance. The Government has the right to change or modify this quality assurance surveillance plan and methods at its discretion.

19.2 Surveillance Methods: The contractor’s performance will be monitored by the Government Point of Contact (GPOC) or Contracting Officer’s Representative (COR) in conjunction with input from the customers. Completed delivery of services will be verified with the PWS prior to making any payment approvals. Incomplete or delayed performance will be forwarded to the Contracting Officer.

19.3 Remedy: Should unacceptable performance occur, the government will document the contractor’s past performance, issue cure notices or may terminate the contract by default.

20. CONTRACTOR MANPOWER REPORTING

22.1 ACCOUNTING FOR CONTRACT SERVICES- The contractor shall report ALL contractor labor hours (inclusive of subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. Reporting shall be accomplished online by going to web address: http://www.SAM.gov/, and then clicking on the “Service Contract Report” section of SAM. The reporting period is the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer.”

CMR ITEM REQUIREMENTS:

2. Contract Number

3. Beginning/Ending Dates covered

4. Contractor Name, Address, Phone Number, email, & POC

5. Estimated Direct Labor Hours (including sub-contractors)

6. Estimated direct labor dollars paid this reporting period (including sub-contractor

7. Total Payments (including sub-contractor)