SOW - Medivators Service - 20211027.docx

STATEMENT OF WORK

MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEMS

SOUTHEAST LOUISIANA VETERANS HEALTH CARE SYSTEM, NEW ORLEANS, LA

1.0 BACKGROUND

The Advantage Plus Endoscope Reprocessing systems are considered critical equipment for Sterile Processing Services (SPS) at the Southeast Louisiana Veterans Health Care System (SLVHCS). As such, this equipment shall be maintained with ultimate care by trained and certified personnel at all times. The proposed contract for this requirement will provide annual preventive maintenance, annual training, corrective maintenance as needed (including labor, travel, and parts), and telephone technical support services.

2.0 SCOPE

The purpose of this requirement is to initiate a new service agreement/contract for the four Advantage Plus Endoscope Reprocessing systems at SPS in SLVHCS. The proposed service agreement/contract would cover all necessary software, application usage maintenance, updates, system enhancements, and 24-hour support for the following base year of twelve (12) months: 1/26/2022-1/25/2023 with four (4) one-years option periods.

3.0 TASK SUMMARY

Furnish all parts and labor to support and maintain in good working condition the four Advantage Plus Endoscope Reprocessing systems in SPS located at the SLVHCS, 2400 Canal St., New Orleans, LA 70119.

All materials and services provided shall be in accordance with the OEM specifications and guidelines. During scheduled service intervals, all parts including batteries and accessories shall be replaced at no additional cost to the Government. Unscheduled and scheduled travel are included as part of the service contract. The Scope of Work includes the following items:

· Unscheduled maintenance Services: Unlimited onsite service 24/7/365

· Schedule maintenance Services: Two (2) scheduled maintenances per unit

· Technical Telephone Support:

6 am - 10 pm CT, Monday through Friday, on business days 6 am - 6 pm CT on non-business days 7 days / week including holidays

· OEM Materials, parts & tool kits required for maintenance

· OEM Software updates for the equipment

· Authorized certified personnel to perform maintenance

· Travel due to maintenance

· Mandatory safety corrections

4.0 SPECIFIC TASKS

Contractor shall furnish all parts, maintenance kits, consumable and expendable items, and supplies necessary to perform schedule and unscheduled maintenance of the units. All materials and services provided shall be according to the OEM specifications and guidelines. During scheduled service intervals, all parts including new batteries and accessories shall be replaced at no additional cost.

SCHEDULED SERVICES: Contractor shall perform the OEM’s Scheduled Periodic Manufacturer’s Certification, electrical safety checks, and software updates on the equipment. Scheduled travel is included as part of the service contract. Schedule services performed shall be based on OEM recommended intervals.

If the OEM recommended intervals change, the Contractor must notify Clinical Engineering at SLVHCS immediately. Should the OEM recommended interval frequency increase, the Contractor shall perform the additional scheduled maintenance at no cost to SLVHCS during the contractual period. The Contractor’s technical service representative must contact Clinical Engineering at least three weeks prior to scheduled maintenance date to coordinate the work. All services shall be performed during normal working hours unless an emergency repair or special coordination is made with Clinical Engineering and/or SPS. Normal working hours for SLVHCS are 07:30 AM to 07:00 PM Central Time, Monday through Friday.

UNSCHEDULED SERVICES: Contractor shall perform all unscheduled services, including emergencies. This includes on site visit 8am-5pm CT 7 days a week. All repair labor and travel costs are included in the contract. In cases when technical support is required over the phone, contractor must be available during the hours 6 am and 6 pm Central time, with after-hours support from 6 pm to 10 pm, Monday through Friday, on business days and 6 am to 6 pm Central time on non-business days seven days a week including holidays to SLVHCS staff at no additional cost. All visits must be scheduled and coordinated through Clinical Engineering and SPS. Any work performed outside of this contract must be approved by COR beforehand.

PARTS: All parts shall be furnished by the contractor. All parts shall be of current manufacturer standards, be new, and have versatility with presently installed equipment. All newly installed replacement parts become the property of the Government. Replacement parts are to be disposed of by the Contractor after obtaining approval from the Contracting Officer’s Representative.

OEM SOFTWARE UPDATES: All software updates and licensing fees shall be installed by the contractor to current OEM specifications during schedule services at no additional costs. Applicable software will need to be validated by Clinical Engineering to conform to agency’s architecture and accessibility standards. Installation process must comply with security, privacy, and safety issues according to the VA standards, policies, and directives set forth. Must meet all requirements of VA Handbook 6500 and Directive 6550.

MANDATORY SAFETY CORRECTIONS: Equipment requiring mandatory safety corrections per OEM or FDA regulations is within the scope of this contract.

OPERATIONAL UPTIME - REQUIREMENTS: - The Advantage Plus Endoscope Reprocessing systems shall be operable and available for use 97% of the normal operating hours of the equipment as detailed in paragraph 3.0, Task Summary. Downtime will be computed from notification of problem during normal work hours. Scheduled maintenance will be excluded from downtime. Operational Uptime will be computed during a month long time period. Repeated failure to meet this requirement can subject the contractor to DEFAULT action.

5.0 PERSONNEL

Contractor shall provide all personnel necessary to maintain the systems. Labor required for both scheduled and unscheduled (emergencies) services are inclusive of the contract. The Contractor’s employees shall be fully trained, qualified and licensed to maintain this critical equipment. The Field Service Engineers shall be authorized by the Contractor to perform the maintenance services. The Field Service Engineers shall be authorized and qualified by the OEM. All work shall be performed by "Fully Qualified" competent Field Service Engineers. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved Field Service Engineers for each make and model. All technical service representatives from the contractor shall comply with VA security management program and obtain permission of the VA police, be identified by work and employer, and restricted from unauthorized access.

6.0 RESPONSE TIME

Response Time: - Contractor's FSE must respond with a phone call within 4 hours after receipt of telephoned notification within timeframe specified in 4.0. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within 24 hours after the vendor’s Technical Service team is notified if deemed an emergency or 48 hours if otherwise.

7.0 MOBILE MEDIA SCANNING

The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. COR or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to any connection to any medical device system. The computer system for scanning removable media will be designated by the COR.

8.0 REPORTS/DOCUMENTATION

For any services performed on site, upon arrival at the Medical Center, the technical service representative shall check in with Clinical Engineering before performing any warranty, repairs and/or maintenance services. This check-in is mandatory. A legible, signed service report shall be provided directly to Clinical Engineering following completion of each call and shall include equipment identification (i.e. serial number), date and time of service call, list of parts replaced, results of inspections and/or calibrations, and a description of work accomplished. The report shall be signed or initialed by SLVHCS Clinical Engineering. Service reports must be provided within five days of completion of the maintenance work. All service reports shall be emailed to VHANOLClinicalEngineering@va.gov and the Biomedical Equipment Support Specialist coordinating the work.

9.0 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

A Contractor/Subcontractor will not need logical (technical) or physical access to VA information and VA information systems for their employees, Subcontractors, or affiliates to perform preventive or corrective maintenance on the equipment.

10.0 VHA SUPPLEMENTAL CONTRACT REQUIREMENTS FOR ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL CONTRACTORS

Contractor employees who work in or travel to VHA locations must comply with the following:

1. Documentation requirements:

0. If fully vaccinated, shall show proof of vaccination. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination

0. If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

0. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

0. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the following website: COVID-19 Screening Tool. Regularly check the website for updates.

a) Contractor employees who work away from VA locations, but who will have direct patient contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.