SOW_Terarecon Neuro.docx

Statement of Work (Draft)

A. GENERAL GUIDANCE

1. Title: TeraRecon Neuro software package- at Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, TX.

2. Scope of Work: The contractor shall provide standard service and support for government owned Terarecon PACS system required by the requirements stated herein. The facility is located at:

MEDVAMC

2002 Holcombe Blvd.

Houston, TX. 77030

3. Background: MEDVAMC has a need to ensure the continuous reliability of the Terarecon PACS software. This system is a Picture Archiving Computer System (PACS) for evaluation and management of dementia, multiple sclerosis (MS), traumatic brain injury (TBI), epilepsy, stroke, and neuro-oncology.

Quantity

Number of Runs per Algorithm 1,300

5 (1,000 runs per year)

per AI Algorithm

B. GENERAL REQUIREMENTS

1. This agreement includes software installation for the Terarecon PACS system for continuous reliability.

a. Services included and to be provided under the standard service coverage include the following:

i. Software licensing and support

ii. Software: On-premises implementation of TR AI Framework (Eureka Clinical AI), Cercare MR Neuro Advanced package FDA cleared 1,000 runs, and Combinostics cNeuro cMRI, TR AI Platform premier success per AI Algorithm, TR Connect per Interface, TR AI framework implementation package.

iii. Telephone and Remote Support – Provide necessary operating system and applications software support, including telephone and online support 24x7.

iv. On-site emergency service

v. Ongoing Software updates

b. Remote Service:

i. Personnel with OEM equipment training will respond directly by phone within 2 hours of the call for service. If situations are responded to by phone and do not resolve the service issue, OEM trained personnel will be required for an on-site visit within 1 business day after receipt of initial notification unless otherwise agreed upon, in writing, by Biomedical Engineering personnel. Full resolution is expected within 48 hours of initial call. If the contractor cannot remediate the issues within this timeframe, Biomedical Engineering personnel shall be notified immediately and provided an estimated time for resolution.

c. Hours of Coverage:

i. The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (EST) M-F), but 24x7 service will be provided when necessary.

ii. Customer service shall respond to service request calls 24 hours a day, 7 days a week and all holidays.

d. Customer Notification:

i. Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all preventative maintenance with Biomedical Engineering. All vendor mobile media devices (USB drives, CDs, DVDs, etc.) must be scanned by Biomed before use.

ii. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s) per Section E.

iii. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s) to the designated personnel. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to Biomedical Engineering for an "authorization signature." A signed accepted copy of the ESR will be sent to Biomedical Engineering within five business days of work completion.

iv. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT.

C. DEFINITIONS/ACRONYMS:

1. Biomedical Engineering - Supervisor or designee

2. CO - Contracting Officer.

3. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.

4. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Medical Center premises.

5. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

6. Acceptance Signature - VAPHI employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

7. Authorization Signature – Biomedical Engineering Staff signature; indicates Biomedical Engineering accepts work status as stated in ESR.

8. NFPA - National Fire Protection Association.

9. CDRH - Center for Devices and Radiological Health.

10. VAPHI - Department of Veterans Affairs Philadelphia Medical Center.

11. OEM - Original Equipment Manufacturer

12. CEU – Continuing Education Credit

D. CONFORMANCE STANDARDS:

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

E. DOCUMENTATION/REPORTS:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards.

F. SCHEDULE FOR DELIVERABLES

Draft copies of deliverables shall be provided to Biomedical Engineering staff at MEDVAMC before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable.

G. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

H. SERVICE MANUALS/TOOLS/EQUIPMENT

1. MEDVAMC shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

2. Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by MEDVAMC. Test equipment calibration shall be traceable to a national standard.

I. CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in this scope of work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

J. CONTRACTOR EXPERIENCE REQUIREMENTS

1. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

2. Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment system identified in this SOW.

3. The FSE(s) shall be authorized by the contractor and OEM to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any MEDVAMC equipment. The CO and/or Biomedical Engineering specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the MEDVAMC equipment.

4. If coming on-site, contractor personnel must provide a copy of: 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate.

K. CONFIDENTIALITY AND NONDISCLOSURE:

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

L. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS:

1. The contractor's FSE shall wear visible identification at all times while on the premises of MEDVAMC. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name.

2. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. MEDVAMC will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

3. Smoking is prohibited inside any buildings and on premise at MEDVAMC. This covers all smoking and tobacco products, including but not limited to:

a. Cigarettes

b. Cigars

c. Pipes

d. Any other combustion of tobacco

e. Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars.

f. Chewing tobacco

4. Cellular phones and two-way radios are not to be used within six feet of any medical equipment.

5. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

M. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS[footnoteRef:1] [1: ]

1. Contractor may not have access to the VA network or any VA sensitive information under this contract.

2. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT.

3. The following language from VA Handbook 6500.6 is required in this contract:

a. Appendix B: All

b. Appendix C: Paragraphs 1, 2, 3, 5, 6, 7, 9

4. All Contractors must receive Privacy training annually using one of the following methods:

5. Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. Biomedical Engineering Staff must ensure that all contractors are validated in the PIH domain.

6. Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to Biomedical Engineering.