Belimed SOW 4-10-24.docx

Belimed Washer & Disinfector Service Contract 2237: 693-24-3-047-0088

STATEMENT OF WORK

Belimed Washer & Disinfector Service Contract (04/10/2024)

1. SCOPE

The purpose of this Statement of Work (SOW) is to procure a service contract for corrective and preventive maintenance for medical systems and devices in use by the Sterile Processing Department at Wilkes Barre Va Medical Center. This scope of work addresses the Belimed WD-290.

In accordance with Appendix A, Handbook 6500.6 Checklist blocks 7, the C&A requirements do not apply to this requirement, and Security Accreditation Package is not required. In reference to no. 7, there is no information to be protected.

2. OBJECTIVES

2.1 The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract

2.2 Ensure all equipment is maintained to operate in a correct and safe manner as intended and designed by the Original Equipment Manufacturer (OEM).

2.3 Ensure that preventive maintenance (PM) is completed on time and in accordance with OEM recommendations (up to 3x per annual year).

2.4 Ensure the software operates as designed and is updated with the latest versions.

2.5 Ensure that all items are inspected to verify items operate correctly and follow applicable local, state, and federal regulations.

3. TASKS

3.1. Vendor to provide services during the hours of 8AM – 4:30PM, Monday – Friday.

3.2. Vendor to provide final quality inspections performed in accordance with 21 CFR Part 820 (FDA Quality Systems Regulations) and ISO 13485.

3.3. Vendor to provide 24 hour replacements and loaners for equipment that is down.

3.4. Vendor to provide unlimited and comprehensive repairs on all equipment listed in Appendix A.

3.5. Vendor to provide Preventative Maintenance coverage in accordance with the Manufacturer's specifications and at the Manufacturer's recommended intervals. PM work will be scheduled at mutually agreeable times, to be completed according to the PM Schedule.

3.6. Vendor to provide all service repairs and remedial maintenance required to maintain equipment at manufacturer’s specifications during service hours.

3.7. Vendor to provide all parts required to maintain the equipment to manufacturer’s specifications.

3.8. Vendor to provide priority response time of 2 hours by phone and 48 hours onsite.

3.9. Vendor to include all travel and living expenses at no charge to facility.

3.10. Vendor will provide documentation for each occurrence that service is provided. The documentation can be a hard copy or electronic transmittal to the Biomedical Department. Other forms of notification or adjustments to this method may be requested by the Vendor and considered for approval by Biomed Representative.

3.11. Service tickets/documentation will be provided within 10 days of the actual work being completed.

3.12. All test equipment used for this contract will have current calibration dates verifiable with documents traceable back to the US Bureau of Standards. Vendor will produce documents upon request.

3.13. Proper Lockout/tag out procedures will be used when appropriate.

3.14. All OEM recommended safety aspects of the equipment being serviced will be adhered to.

3.15. All work will be completed in accordance with Original Equipment Manufacturers (OEM) specifications and recommended procedures.

3.16. All adjustments will be completed using OEM software as intended by the equipment design.

4. DELIVERY & SCHEDULING

4.1. All on-site work should be completed between the hours of 8am and 4:30pm EST, Monday through Friday excluding holidays unless otherwise listed in the tasks section.

4.2. All preventive maintenance (PM) will be accomplished within the scheduled month.

4.3. PM visits should be scheduled no less than three business days before expected arrival to assure equipment availability.

4.4. If the VA agrees to afterhours billable service, it will be charged at the vendor’s preferred contract billing rate in affect at the contract start date.

4.5. If vendor desires to provide service after normal hours at no additional cost to the VA, a request can be made to Biomed for an escort. After hours work will normally only be approved, if a VA escort is available to stay with the vendor during all work.

4.6. Biomed Representative will be informed in the following situations:

4.6.1. To schedule any work.

4.6.2. After arriving on site, but before any work is started.

4.6.3. To provide an approximate timeframe for the work.

4.6.4. As soon as it is known that the work will take longer than expected.

4.6.5. At completion of work prior to leaving the facility.

4.6.6. To report any incomplete aspects of the work or issues that could not be corrected during the visit.

4.6.7. To provide a written plan for corrective action for any work that cannot be completed within 24 hours. Plan must be provided to and approved by Biomed Representative.

4.7. Vendor will provide documentation for each occurrence that service is provided.

4.7.1. Documentation to be provided within 5 business days of work completion.

4.7.2. The documentation can be hard copy or electronic transmittal. Hard copy given to Biomed Representative. Electronic copy sent to the COR, as designated in the COR Nomination Letter.

5. SECURITY REQUIREMENTS

5.1. Vendors will obtain a contractor access badge from VHA Police while performing work on-site.

5.2. Electronic Media:

5.2.1. Removeable media (USB flash drive, DVD/CD, laptop,) must be scanned by Biomed Representative prior to use on VHSO equipment.

5.2.2. Media that has contained electronic Patient Information (Hard Drives, RAM, Etc.) must remain in VHSO custody for destruction.

5.3. Security and privacy requirements vary depending on the equipment to be serviced and the service being performed. Vendor personnel may be required to complete any or all the following but not limited to:

5.3.1. Online training.

5.3.2. Read, sign, and comply with ‘Vendor Rules of Behavior’.

5.3.3. Submit to finger printing and background investigation.

5.3.4. Provide network security information as requested for any equipment used in the VA facilities.

5.4. The extent of these requirements will be determined by Biomed using current facility Information Technology and Privacy rules in cooperation with experts in those departments.

5.5. All personnel completing tasks will have factory certified training on the equipment that they will service. Vendor will provide training documentation when requested by Biomed.

6. PLACE OF PERFORMANCE

6.1. Work will be performed on equipment at the following locations:

6.1.1. Wilkes Barre VA Medical Center, 1111 East End Blvd, Wilkes Barre PA 18711

6.2. Equipment may not be removed from the facilities for service without authorization from Biomed Representative.