SOW_3Mensio_Reordered Sections.docx

GENERAL GUIDANCE

Title: Esaote 3mensio Software Support Agreement for VA Pittsburgh Healthcare System (VAPHS)

Scope of Work: The Contractor shall provide software licenses as well as software updates/upgrades of 3mensio utilized by government. The contractor is also to provide maintenance and support of the software in accordance with the requirements stated herein. The facility is located at:

VA Pittsburgh Healthcare System University Drive Campus 4100 Allequippa St Pittsburgh, PA 15240

Background: The 3mensio software system is currently installed in the cardiology department at VAPHS. The 3mensio software is utilized as a planning system for surgeries performed in cardiology. The software is used to assess the structure of the heart and vascular system in order to plan and perform surgical procedures. This software is critical to ensure proper functionality and provide continuous patient care to Veterans.

Performance Period: Five (5) years after date of award Type of Contract: Firm-fixed-price.

GENERAL REQUIREMENTS

This agreement shall provide software support and software updates/upgrades for the 3mensio software system for continuous reliability.

Equipment to be included:

· Software Maintenance.

· Perform mandatory safety and reliability modifications.

· Perform all major software upgrade releases by installing most recent production version by Esaote.

· Provide all optional maintenance releases and service packs from Esaote.

· Provide training associated with software upgrades and updates (major and optional releases), with additional days as needed at no additional charge.

· Annual refresher training shall be provided in any year that a software upgrade is not released. Training shall occur via Internet, multi-media, or onsite as agreed by Esaote and clinical staff.

· Maintain functionality of existing interfaces originally created by Esaote. Esaote will perform all modifications and changes to existing and working interface that are required due to an Esaote software update or upgrade.

Software and Licenses:

· Software patches of 3mensio to include quality updates/upgrades are included under the terms of this contract and shall be applied in accordance with manufacturer specifications.

· Any licensing required to automate the reporting of VAPHS owned Esaote equipment will be included in this contract.

· Software delivery of 3mensio shall be delivered via download or to the address for the delivery specified in the order.

Support Services:

· Service calls to the Contractor requesting service are only authorized when they are received from the Contracting Officer Representative (COR) or designated alternates.

· Outside of the Contract’s hours of coverage, emergency on-site services require authorization by the COR. The COR or a Biomedical Engineering Staff Member shall initiate these calls. If VAPHS staff other than the COR or a Biomedical Engineering Staff Member place calls requesting services, the Contractor shall contact Biomedical Engineering services and verify the request. Service responses on calls from unauthorized personnel can result in nonpayment. The VA Administrative Officer of the Day is an authorized caller and can also be contacted for verification.

Uncorrected deficiencies or unfavorable histories of downtime can result in the termination of this contract under the Termination for Default clause of the Federal Acquisition Regulation.

Hours of Coverage:

· The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (ET) M-F), excluding holidays.

All services shall be performed during these normal hours of coverage unless one of the following conditions exists:

· The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to the COR prior to the proposed start of the work, and the request is approved in writing by the COR before work is begun.

· The COR directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended by the COR and authorized by the CO.

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

· Work performed outside the normal hours of coverage must be preapproved by the CO, and COR or Alt COR. The Contractor will provide a written estimate of the charges prior to approval of the work.

· Work performed outside the normal hours of coverage at the request of contractor shall be considered service performed during normal hours of coverage.

· Note: Any software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government.

Federal Holidays Observed by the VA Medical Center New Year’s Day, Martin Luther King, Jr. Day, President’s Day (Washington’s birthday), Memorial Day , Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States.

Customer Notification:

Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all maintenance with Biomedical Engineering.

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

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

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.

Biomedical Engineering - Supervisor or designee, Phone Number (412) 360-3780

DEFINITIONS/ACRONYMS:

CO - Contracting Officer.

COR - Contracting Officer's Representative.

PMI - 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. PMI includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PMI.

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.

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.

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

Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

NFPA - National Fire Protection Association.

CDRH - Center for Devices and Radiological Health.

VAPHS - Department of Veterans Affairs Pittsburgh Healthcare System.

OEM - Original Equipment Manufacturer

CONFORMANCE STANDARDS:

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, JC, 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.

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. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

Name of Contractor Name of FSE who performed services.

Contractor Service ESR Number/Log Number.

Date, Time (starting and ending), Hours-On-Site for service call.

VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

Description of Problem Reported by COR/User.

Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

Total Cost to be billed.

Signatures from the following:

FSE performing services described.

VA Employee who witnessed service described.

Equipment downtime calculated in accordance with Conformance Standards.

Note: Any additional charges claimed must be approved by the COR before service is started.

SCHEDULE FOR DELIVERABLES

Draft copies of deliverables shall be provided to Biomedical Engineering staff at VAPHS 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.

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.

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.

CONTRACTOR EXPERIENCE REQUIREMENTS

Each respondent must be an authorized provider or distributor of the original equipment manufacturer. This documentation shall be provided if required by COR or Biomedical Engineering.

SECURITY REQUIREMENTS

If working on-site, contractor will be required to comply with security guidelines. Contractor is required to:

Agree to follow VA Pittsburgh Policy LD-073 medical center policy (MCP) Vendor Access. Be registered on the vendor credentialing and visitor management system called Symplr - https://www.symplr.com/. Add VA PITTSBURGH HEALTHCARE SYSTEM UNIVERSITY DRIVE: PITTSBURGH, PA to their territory. Contractor must be “greenlighted” prior to working on site. Greenlight requires completed information and up to date documentation which includes an up-to-date flu vaccination, Tb test, Covid-19 vaccine, and HIPAA certification at a minimum.

The government shall not provide any additional compensation for cost to register Esaote staff in Symplr. Vendor shall follow most updated guidelines from the Occupational Safety & Health Administration (OSHA), Center for Disease Control (CDC), and Food & Drug Administration (FDA).

Check in with the VA Police and Biomedical Engineering (Ground floor, Room AN305C) each time they come on-site to perform contracted services or by obtaining a VA Contractor ID badge from the VA Police. VA ID badge must be worn at all times while on VA premises.

Check out with Biomedical Engineering and provide summary of work done.

CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

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.

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.

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.

COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall:

Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

INFLUENZA PREVENTION PROGRAM:

VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Healthcare personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. Those HCP unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

Documentation of vaccination, e.g., signed record of immunization from a healthcare provider or pharmacy, or a copy of medical records documenting the vaccination.

Completed Healthcare Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

The contractor is required to submit annual certification to the Contracting Officer’s Representative (COR) that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192.

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

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

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. VAPHS will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

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

Cigarettes Cigars Pipes Any other combustion of tobacco Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars.

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

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.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

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

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.

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

Appendix C: Paragraphs #3a, #5h, #6a, #7a, #7d, #9(all) All Contractors must receive Privacy training annually using one of the following methods:

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. The COR must ensure that all contractors are validated in the PIH domain.

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 the COR.

Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR.