PWS Medtronic FY23-24.docx

PERFORMANCE WORK STATEMENT (PWS)

Medtronic Equipment Maintenance Agreement; Biomedical Engineering Services (BES)

Part 1

General Information

1. GENERAL: This is a non-personnel services contract to provide Protection 1 Risk-Share Comprehensive Service Agreement for the maintenance and repair needs of the two Medtronic Radiologic O-Arms Serial #s C2329 and C2821 under the equipment list for Brooke Army Medical Center, Ft. Sam Houston, TX for human use. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform repair and services as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract. Brooke Army Medical Center (BAMC), Logistics Division is responsible for this contract and on-site services will be performed within the BAMC facility.

1.2 Background: Medtronic uses proprietary software to perform scheduled and repair services. The equipment allows BAMC medical providers to provide treatment during surgical procedures. The Medtronic O-Arm is used for navigated spine hardware placement, biopsies, places shunts, and laser catheters with advanced visualizations for clinicians.

1.3 Objectives: The purpose is to provide the best maintenance for medical equipment in accordance with the manufacturer's maintenance manuals, specification, and quality control policies and procedures governed by the BAMC Biomedical Engineering Services (BES) and the respective using activity. Information concerning the systems to be serviced is furnished from the best available sources. HOWEVER, this shall not relieve the Contractor or the requirement for visiting the location of the systems listed and to be thoroughly familiarized with all components associated with the item(s) and conditions under which the work is to be performed.

1.4 Scope: Scheduled and unscheduled services. Services include actions relating the preventive maintenance, operation verification and certification of the system and its components. The contractor shall perform one complete scheduled service inspection consisting of clean, calibrate, lubricate and align all mechanical and optical components include all supplies. The contractor will perform services according to the manufacturer’s specifications either semiannually or annually. Unscheduled services are those services relating to the repair and/or replacement of parts in the system or components.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and four (2) 12-month option years. The Period of Performance reads as follows:

Base Year – 21 June 2023 – 20 June 2024 Option Year 1 - 21 June 2023 – 20 June 2025 Option Year 2 - 21 June 2023 – 20 June 2026

1.6 General Information

1.6.1 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 Recognized Holidays: The contractor is not required to perform services on the holidays listed below. But if any of the holidays listed is not a holiday that the contractor considers a holiday, services can be performed without any added costs only with the COR authorization.

Juneteenth Day

1.6.4 Hours of Operation: The contractor is responsible for conducting business unless specified otherwise in the contract, between the hours of 0730hrs to 1630hrs, Monday thru Friday, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at Brooke Army Medical Center and any associated clinics outside of the hospital.

1.6.6 Type of Contract: The government will award a (Type of contract to be determined by CCE and the customer).

1.6.7 Security Requirements: Contractor personnel performing work under this contract must have either and access base pass or a DBIBS ID card submitted by the COR or ACOR and approved by 502nd Security Forces Squadron, Fort Sam Houston, TX at time of the proposal submission, and must maintain the level of security required for the life of the contract.

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

1.6.7.2 Key Control. The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the Contracting Officer.

1.6.7.2.1. In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

1.6.7.2.2. The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

1.6.7.3 Lock Combinations: The Contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The Contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the Contractor’s Quality Control Plan.

1.6.8 Special Qualifications: The field service technician shall be authorized, certified, and trained in the maintenance of the Medtronic medical equipment. Additionally, the service technician shall have a minimum of two years’ experience within the last 36 months.

1.6.9 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

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

1.6.11 Key Personnel: The follow personnel are considered key personnel by the government: Jose Victor Castillo, Primary COR, 210-916-3068; Art. Navarrette, Secondary COR, 210-916-8966. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 0700 – 1600 (7 a.m. – 4 p.m.), Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below: Must have completed the required training to be a Contracting Officer Representative (COR).

1.6.12 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.6.13 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.14 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may effect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

2.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.12. WORKDAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Services: The Government will provide a BES technician to observe a quality assurance test, in accordance with the QASP, prior to the departure of the contractor’s service technician.

3.2 Facilities: The Government will provide access to the devices and systems requiring services.

3.3 Utilities: The Government will provide all necessary utilities, including power to the devices, required to perform the service. The Contractor shall instruct employees in utilities conservation practices. The contractor shall be responsible for operating under conditions that preclude the waste of utilities, which include turning off the water faucets or valves after using the required amount to accomplish cleaning vehicles and equipment.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2. Materials. The Contractor shall provide parts and materials required to perform the services outlined in this PWS.

4.4. Equipment. The Contractor shall provide equipment required to perform services and quality assurance test outlined in this PWS.

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.1. Basic Services. The contractor shall provide scheduled and unscheduled services for the two Medtronic Radiologic O-Arms SN# C2329 and C2821 Radiology Systems.

5.2. Scheduled Services. Scheduled services are those actions relating the preventive maintenance, operation verification and certification of the system and its components. The contractor shall perform one complete scheduled service inspection consisting of clean, calibrate, lubricate and align all mechanical and optical components include all supplies. The contractor will perform services according to the manufacturers’ specifications either semiannually or annually. The contractor will adhere to the following when performing scheduled services:

a. Contractor must coordinate expected arrival date and time with Contractor Officer Representative (COR) and completed by the 15th business day of scheduled month.

b. Brooke Army Medical Center (BAMC) - normal operating hours are Monday thru Friday, 0730 — 1630 (7:30am - 4:30 pm). Any services outside normal duty hours must be coordinated by COR.

c. Update DD Form 2163, Medical Equipment Verification and Certification sticker on the medical device as needed. The DD Forms are available in the Biomedical Engineering Services upon request. If field service technician has any question contact COR.

d. All software updates based upon original OS and Application purchased configuration excludes software/hardware performance upgrades.

e. Prepare and provide a maintenance service report for all services rendered. Service reports must be received by the COR NLT 72 hours from completion of work.

5.3. Unscheduled Service. Unscheduled services are those services relating to the repair and/or replacement of parts in the system or components. The contractor shall provide unlimited on site repairs for unscheduled service request as follows:

a. 1 hour telephonic response and 4 hours on-site response for a down system. The contractor provides the parts and labor at no cost.

b. Brooke Army Medical Center (BAMC) normal operating hours are Monday thru Friday, 0730 — 1630 (7:30am - 4:30 pm). Unscheduled services can be performed outside of normal operating hours; Any services outside normal duty hours must be coordinated by COR.

c. Only accept unscheduled service request from the appointed COR or designated representative.

d. Prepare and provide a maintenance service report for all services rendered. Service reports must be received by the COR NLT 72 hours from completion of work.

e. All software updates based upon original OS and Application purchased configuration excludes software/hardware performance upgrades.

5.4. CONTRACTOR MANAGEMENT REPORTING (CMR): The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The Contractor is required to completely fill in all the information in the format, using the following web address https://www.ecmra.mil, by the seventh day of the new fiscal year.

The required information includes:

(1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative;

(2) Contract number, including task and delivery order number;

(3) Beginning and ending dates covered by reporting period;

(4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data;

(5) Estimated direct labor hours (including sub-contractor);

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

(7) Total payments (including sub-contractor);

(8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); 0UJ21

(9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information); W81NTE

(10) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website);

(11) Presence of deployment or contingency contract language, and,

(12) Number of Contractor and sub-contractor employees deployed in theater this reporting period (by country).

(13) As part of its submission, the Contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement.

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.

PART 7

ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1. Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

7.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule

TECHNICAL EXHIBIT 1

Performance Requirements Summary The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement)

Method of Surveillance

PRS # 1.

The contractor shall provide fully certified contractor personnel.

Paragraph 1.6.8

PRS # 2

The contractor shall provide a service report within 24 hours.

Paragraph 5.2.e and 5.3.d

PRS # 3

The contractor shall provide scheduled services by the 15th business day of the scheduled month.

Paragraph 5.2.a

PRS # 4

The contractor shall provide telephonic unscheduled (repair) services response within 1 hour of COR contact.

Paragraph 5.3.a

PRS # 5

The contractor shall provide on-site unscheduled (repair) services response within 4 hour of COR contact.

Paragraph 5.3.a

PRS #6

The contract shall complete the Contractor Management Report within 7 days of the new fiscal year.

Paragraph 5.4

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

1 copy

Email PDF copy (preferred) or hard copy.

Email:Jose.V.Castillo.civ@mail.mil; and arthur.navarrette.civ@mail.mil

Hard Copy address:

Brooke Army Medical Center 3551 Roger Brooke Drive, Fort Sam Houston, TX 78234 ATTN: Biomedical Engineering, Room TC-L28