SOW- Shockwave Machines.pdf

STATEMENT OF WORK (SOW)

PURPOSE:

The purpose is to procure 2 of the brand name below or equal to Chattanooga’s Intellect Focus Shockwave Set, including accessories for the Amarillo VA Medical Center and Lubbock Outpatient Clinic locations. The Intellect Focus Shockwave electromagnetically generates an extracorporeal shock wave, which produces a high-pressure peak in a very short amount of time (<2s). This can penetrate deep into the tissue, up to approximately 4.7", with a precise focus on a small target, for treating heel pain due to chronic proximal plantar fasciitis.

Chattanooga’s Intellect Focus Shockwave Set- Quantity 2 Stand-off I (short)- Quantity 2 Stand-off II (long) - Quantity 2 Closing ring transparent for stand-off I and II- Quantity 2 Focus Shockwave Handpiece- Quantity 2 Focus Shockwave Water Bag- Quantity 2 Focus Shockwave Silicone Oil- Quantity 2 Focus Shockwave Operating Manual- Quantity 2 Shockwave Power Cord US- Quantity 2 Focus Shockwave Handpiece holder- Quantity 2

GOVERNMENT FURNISHED RESOURCES:

Information Sources. Agency personnel shall be available for technical exchanges.

Documentation: Packing list shall include lot numbers, serial numbers and expiration dates of all delivered products and equipment.

SECURITY REQUIREMENTS:

• In reference to VHA Handbook 6500.6 Appendix A, blocks 6 and 7, the equipment included in this contract does not capture and process ePHI over the hospital network.

• In reference to VHA Handbook 6500.6 Appendix A, Block 6, the equipment (or service) included in this contract does not involve connection of IT devices to a VA network. Therefore, C&A, SAP, & the following from App C do not apply.

• The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information protection, patient privacy, and security systems as delineated in this contract.

• During install, training, warranty repair and/or maintenance provided by the contractor, they may have physical administrative access to the equipment included in this contract that capture and process ePHI. If warranty repair is done off-site, all hard drives or other data storage devices will be removed or purged off data, prior to release to contractor.

• Privacy and HIPAA Focused Training Web-Based (WBT): VA Course No. VA10203 is the official privacy training for VA employees, contractors, and volunteers who have access to protected health information (PHI) in the performance of their official duties or have access to VA systems (e.g. CPRS or VistA Web). All contracted employees will complete this training prior to being granted access to the subject equipment, or to the data therein. The training is available on the VA TMS website at: https:// www.tms.va.gov. The contractor will provide evidence of training to the COR, if requested.

• The Contractor personnel must follow all VA policies, standard operating procedures, applicable laws and regulations while on VA property. Violations of VA regulations and policies may result in citation and disciplinary measures for people violating the law.

• The Contractor must obtain all necessary licenses and/or permits required to perform the work, except for software licenses that need to be procured from a Contractor or vendor in accordance with the requirements document. The Contractor must take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract.

PLACE OF PERFORMANCE/ DELIVERY:

The contractor shall provide the following for shipment and delivery of equipment:

Timely submission of deliverables is essential to successfully completing this requirement.

Schedules for deliverables are specified below.

WARRANTY:

The contractor shall provide the standard 12- months warranty; with an option to purchase an extended warranty of 3-5 years that will cover all parts, labor, supplies, travel costs, and user support at no additional cost to the Government.

INSPECTION AND ACCEPTANCE:

Only the Contracting Officer (CO) and the Point of Contact (POC) have the authority to inspect, accept or reject all deliverables. All rejected deliverables will be corrected at the contractor’s expense with no additional cost to the government

• The contractor shall provide a complete set of unabridged operator manuals, service manuals, electronic schematics, troubleshooting guides, and parts lists for each piece of equipment which is part of the system procured by the Medical Center.

• The contractor shall provide a complete set of manufacturer’s cleaning guidelines/instruction for each system component that is used.

PLACE OF PERFORMANCE/ DELIVERY:

• On-site delivery team to perform unpacking, uncrating, and removal of packing material, set up and inside delivery to location specified by Point of Contact or delegate.

The Contractor shall Install the procurement/item to:

1 item-- Amarillo VA Health Care System

6010 Amarillo Blvd. W Amarillo, TX 79106 (Building #53, first floor-room #2370)

1 item-- Lubbock VA Health Clinic 3510 4th Street Lubbock, Texas 79412 (Building #98, first floor-room #231)

HOURS OF OPERATIONS:

Delivery shall be scheduled from 8:00 am - 4:00 p.m., Monday through Friday, excluding Federal Holidays. There are ten (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, five are set by date:

New Year's Day January 1 Juneteenth National Independence Day June 19 Independence Day July 4 Veterans Day November 11 Christmas Day December 25 If any of the above falls on a Saturday, then Friday must be observed as a holiday. Similarly, if one falls on a Sunday, then Monday must be observed as a holiday.

The other six are set by a day of the week and month:

Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November

Mandatory Check in/out and Removable of Media Scanning:

• For any services performed on-site the Contractor must, upon arrival at the Lubbock VA Health Clinic, report to the Facility POC to check in before proceeding to the any department and before performing any services.

• Prior to leaving the Lubbock VA Health Clinic, the Contractor must check out with the POC. This check-in and check-out is mandatory.

• Upon check in the Contractor must ensure that any removable media is scanned by the Biomedical Engineering Section prior to connecting to any Lubbock VA Health Clinic network, device or system. The Contractor must provide any removable media to Biomedical Engineering staff to perform malware/virus scan checks. The Government will not perform any virus or malware removal on the Contractor’s removable media.

• The Contractor shall be responsible for assessing the Lubbock VA Health Clinic for all requirement cabling and other equipment needed for installation.

• The contractor will re-connect the new unit to the existing utilities and perform the start-up check to ensure proper function.

• The Contractor will consult and coordinate with the in-house engineering group to gain access to restricted areas.

• All installation plans will be reviewed and signed off on by the project POC and engineering representative.

POINTS OF CONTACT:

Dr. Brian Green, Whole Health Clinical Director, Community Based Clinics Service Thomas E. Creek VA Medical Center Lubbock Outpatient Clinic 3510 4th Street Lubbock, TX 79415 O: (806) 472-3400 ext. 2423 C: (806) 543-4968 E: brian.green5@va.gov

Operating Constraints:

• All installation and implementation work must be completed during regular business hours from 8:00am - 4:00 p.m., Monday through Friday, excluding Federal Holidays.

Amarillo VA Healthcare System & Lubbock VA Community Based Clinic has discretion to defer/hold any installations if locations are not accessible for the installation process.

Specific Tasks:

The Contractor must perform the following:

• The Contractor must attend a Project Kickoff Meeting where the project must be discussed in detail. The meeting will be conducted by conference call and coordinated by the POC within seven (7) days after the contract award.

• Clinical and Bio-med Staff training is required onsite which will be coordinated by the POC within seven (7) days after the contract award.

Salient Characteristics:

SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE:

This equipment will assist in providing superior care for our Veterans. This is the standard of care outside the VA and with essential features as below:

Must Have the below Requirements:

Chattanooga’s Intellect Focus Shockwave Set

• LCD touch screen

• Enhanced Energy: 0.01 - 0.55mJ/mm2

• Broad Frequency Range: 1 - 8Hz

• 2 stand-off variations

• 4.7" penetration with pinpoint focus

• Benefits

• Short treatment time (a few minutes)

• Precise and targeted application

• Results in a few treatments (1-5)

• Deep tissue can be reached

• Non-invasive and no known significant adverse effects

• Alternative to medication