MEDTRONIC NIM SOW.doc

VA BOSTON HEALTHCARE SYSTEM

PERFORMANCE WORK STATEMENT / SCOPE OF WORK

MEDTRONIC NERVE INTEGRITY MONITOR (NIM)

Preventive Maintenance 523-25-4-7441-0111

REQUESTING SERVICE:

Clinical Engineering.

1.0 Objective: A service contract for annual preventive maintenance and certification of BHS Nerve Integrity Monitors (NIM). In February 2023 BHS purchased two of these devices, one each for Jamaica Plain & West Roxbury. These devices are used during surgery to locate, identify, and monitor patient nerves during surgery. This reduces the risk of nerve damage by alerting surgeons to changes in nerve function. This service and certification are required to meet Federal, State, and hospital credentialing requirements.

1.1 Period of Performance: BHS requests a base and two option years:

Base: 7/31/2025 to 7/30/2026 Option 1: 7/31/2026 to 7/30/2027 Option 2: 7/31/2027 to 7/30/2028

1.2 Type of Contract: Firm Fixed Price.

1.3 Contract Award Meeting: The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick-off meeting or has advised the contractor that a kick-off meeting is waived.

2.0 Background: The NIM monitors are owned by BHS. And cannot be used unless the equipment has undergone a preventive maintenance inspection, parts replaced, calibration, and certification by an OEM trained Engineer within the previous 12 months.

2.1 Protected Health Information (PHI), vendor will not have access to PHI. The only records exchanged between VA and vendor are the equipment test results and invoices. Invoices do not contain PHI.

3.0 Scope: The Vendor shall accomplish the deliverables, provide certified technicians, labor, personnel, equipment, tools, materials, parts, supervision, and other items necessary to perform onsite calibration of the BHS audiology devices listed in paragraph 7.1 below.

3.1 Professional Qualifications: The assigned (FSA) must have the appropriate training, experience, expertise, and certification to work on the equipment identified in paragraph 7.2 below.

4.0 Scheduling a Visit: When required, Vendor must contact the senior Clinical Engineer at VA Jamaica Plain, 150 S. Huntington Ave, Boston, MA 02130 by calling (857) 203-5517 or e-mail Siva.Prakash@va.gov to arrange a mutually agreed upon date and time.

4.1 Security Requirements: FSA shall report to the CE point of contact or another government designated representative to check in and obtain a short-term identification (ID) badge. This must be obtained before any work is performed.

4.2 Identification: FSA must present a current (not expired) Federal ID, PIV card, State or local government ID card/badge before the temporary Federal ID badge is issued. FSA must be current in OEM certification to perform the work.

5.0 Upon Arrival: All contractors must be met by a Clinical Engineer who will verify the FSA’s ID and if acceptable, will escort the FSA to the engineering office where the CE liaison will have the contractor sign in and will then give the FSA a temporary U. S. Government ID badge. The badge shall be worn prominently by the FSA while on VA Property.

5.1 Work Site: The contractor will be escorted by CE staff or other designated VA employee to the work site and must return to CE to sign out and turn-in said badge along with the documented service report for the service performed. If there is a need to replace any hard drive, hard drives, and all information on them, are the property of the VA and must remain in the control of the VA Clinical Engineering department for proper destruction.

6.0 Federal Law: The FSA must follow all Government laws, rules and regulations regarding National Security, patient privacy, and information security. And must adhere to the privacy Act, HIPAA, and COVID-19 screening requirements.

6.1 Unauthorized Work/Parts: Work outside the scope of this agreement is not authorized. Purchase of parts is not authorized.

7.0 Authorized Service: Test, calibration and preventive maintenance on the devices listed in paragraph 7.1 below. Service must meet the manufacturer’s required service frequency and must include all steps detailed in the OEM service manual.

7.1 BHS equipment to be serviced:

7.2 Emergency work: Is not authorized.

8.0 Deliverables: Field Service Report (FSR) must be completed by the FSA and a copy given to CE staff. The FSR must include:

1. Name & work phone number of FSA who performed services.

2. Contractor service ESR number/log number.

3. Date, time (starting and ending), equipment downtime and hours on site for service call.

4. Identification of equipment serviced to include:

a. Facility

b. Inventory “EE” ID number

c. Manufacturer

d. Device name

e. Model number

f. Serial number

8.1 Itemized Description: of Service Performed including: Materials used and Signatures of FSE and BHS employee who verified the work.

8.2 Hours of Coverage: Clinical and technology service support and contract administration available Monday-Friday 8:00am to 4:00pm.

8.3 Maintenance: PM must be completed each year by July 31st following OEM schedule. FSA must follow and complete all steps/part replacement and testing following OEM PM guide.

9.0 VA Information and Information Systems & Privacy: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

9.1 Access to VA Information and VA Information Systems: Vendor does not require access to Protected Health Information (PHI) and will not has access to any Patient information.

9.2 Investigative Requirements: All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

9.3 Custom software development: and outsourced operations must be in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

9.4 Contractor: or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

10.0 VA Information Custody: Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

10.1 VA Information: should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures follow VA directive requirements.

10.2 Prior to Termination: or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

10.3 The Contractor/Subcontractor: must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations, and policies in this contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and VA Handbook 6500.6, Contract Security APPENDIX C. 3.