This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only Solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation number 36C25720Q0642 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular. SET-ASIDE: This requirement is a 100% Total Service-Disabled Veteran Owned Small Business (SDVOSB) set aside under the authority of 38 U.S.C. 8127(d). In order to be eligible for award an offeror must be certified/verified in Vetbiz (www.vip.vetbiz.gov), and small for the applicable NAICS code at the time of the quote submission and at the time of award. Status as a qualified SDVOSB concern is under the authority of 38 CFR Part 74 in accordance with the VA Acquisition Regulation (VAAR) Part 819. Eligibility determination is performed by the Center for Veterans Enterprise (CVE). Only qualified offerors may submit bids. NAICS Code:334614 and Size Standard is $16.5M. Introduction: The Government intends to award a firm fixed price contract based on this solicitation. Description of Services: El Paso Veterans Affairs Health Care System (EPVAHCS) facility has a Tissue Regeneration Technologies (TRT) OrthoGold 100 equipment that is FDA 510K cleared. The OrthoGold 100 uses TRT s patented Software technology to heal a variety of orthopedic indications, to include, shoulder injuries, chronic heel pain, tendon and ligament injuries, and muscle pain. The small size of the OrthoGold 100 makes it easy to transport. Its design makes it easy to handle and simple to operate. Place(s) of Performance: Department of Veterans Affairs Medical EL Paso Health Care System 5001 North Piedra Street EL Paso TX 79930 Type of Contract: A Firm Fixed Price QUOTE SUBMISSION INSTRUCTIONS AND EVALUATIONS: RFQ QUESTION SUBMISSION: Questions must be received no later than Monday, May 11, 2020 at 10:00am CST. Email your questions directly to
[email protected]. The subject line must specify: RFQ 36C25720Q0642- Questions. There will be no automated email notification of receipt of questions. An amendment/modification to the Solicitation will be posted to FBO answering all questions submitted. RFQ QUOTE SUBMISSION: Quotes must be received no later than Friday, May 20, 2020 11:59pm CST. Email your quote directly to
[email protected]. The subject line must specify: RFQ 36C25720Q0642.- Quotes. There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered. EVALUATION OF QUOTES: Evaluation of quotes will be conducted using Simplified Acquisition Procedures in accordance with FAR 13.106-2 Evaluation of Quotes. The Government intends to award one contract resulting from this solicitation. The Government will evaluate quotes across two (2) non-price factors and one (1) price factor for a total of three (3) evaluation factors as follows: Factor 1: Price Contractor shall complete the Price/Cost Schedule and include it with their offer. The Pricing Schedule shall be fully completed and verified to correct any errors. It shall contain the Offeror s prices for all unit prices. Factor 2: Technical Capability. The contractor shall submit a technical response which contains in the statement of work listed below: Each factor will be rated as Satisfactory on Unsatisfactory . Quotes rated as Unsatisfactory in the Technical capability factor will be eliminated from further consideration. QUOTE SHOULD BE BROKEN DOWN AS FOLLOWS: PRICE/COST SCHEDULE ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 Based Year 1.00 YR ________________ ________________ Shockwave Applicator Refurbishing Service EL Paso VAMC, EL Paso TX GRAND TOTAL __________________ ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 1001 Option Year 1 1.00 YR ________________ ________________ Shockwave Applicator Refurbishing Service EL Paso VAMC, EL Paso TX GRAND TOTAL __________________ ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 2001 Option Year 2 1.00 YR ________________ ________________ Shockwave Applicator Refurbishing Service EL Paso VAMC, EL Paso TX GRAND TOTAL __________________ ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 3001 Option Year 3 1.00 YR ________________ ________________ Shockwave Applicator Refurbishing Service EL Paso VAMC, EL Paso TX GRAND TOTAL __________________ ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 4001 Option Year 4 1.00 YR ________________ ________________ Shockwave Applicator Refurbishing Service EL Paso VAMC, EL Paso TX GRAND TOTAL __________________ El Paso Veterans Affairs Health Care System (ELPVAHCS) Tissue Regeneration Technologies (TRT) OrthoGold 100 Statement of Work (SOW) GENERAL El Paso Veterans Affairs Health Care System (EPVAHCS) facility has a Tissue Regeneration Technologies (TRT) OrthoGold 100 equipment that is FDA 510K cleared. The OrthoGold 100 uses TRT s patented Software technology to heal a variety of orthopedic indications, to include, shoulder injuries, chronic heel pain, tendon and ligament injuries, and muscle pain. The small size of the OrthoGold 100 makes it easy to transport. Its design makes it easy to handle and simple to operate. DESCRIPTION OF WORK The OrthoGold 100 equipment utilizes an applicator, in which the acoustic waves are generated and modulated. The applicator will be connected by means of the applicator connector to the device. The OrthoGold 100 recognizes the connected applicator type automatically and shows the name on the display. The applicator is delivered as an accessory. The total number of acoustic waves available in the applicator are 100,000 acoustic waves at an energy level of 1-10. Once the applicator is depleted, it should be sent to the vendor to be refurbished and sent back to EPVAHCS. The vendor shall provide refurbishments of the applicator needed to maintain yearly operation of OrthoGold 100 equipment. A warranty for 100,000 shocks per refurbishment. Failure to get 100,000 shocks, a credit for the missing portion of shocks shall be given to ELP VAHCS. EQUIPMENT LIST: Equipment Type Quantity Model Number Serial Number Location/Room # Manufacture Date/EEN Shockwave 1 Orthogold 100 OW10000439 B438 2019-09-18 PERFORMANCE REQUIREMENTS Maintenance: The vendor shall perform refurbishment maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following: The applicator consists of the following parts: applicator housing, water membrane, and acoustic wave release button. The applicator contains: electrode, reflector, and water membrane. The applicator should be sent in to the vendor after its use life (when the display shows 0 ). The applicator must be shipped in the specific transport box provided by the vendor. Refurbish all components for proper performance. Equipment shall reproduce results according to manufacturer s specifications. After Refurbishment Maintenance, the vendor shall submit a detailed work report to the COR for notice at no additional cost to the government. Each refurbishment to include changing out of the electrode, cleaning out of the water cartridge, and testing of the applicator. Technical Assistance: As needed, technical assistance will be available 24 hours a day, 7 days a week for troubleshooting / breakdown / preventive maintenance. The vendor shall provide technical assistance not limited to performance or equipment malfunction. Shipment to and from Vendor: The ELVAHCS will ship at VA cost the applicator to TRT for refurbishment. The vendor shall perform the necessary reprocessing steps to the applicator. The vendor will ship the refurbished applicator back to the ELVAHCS via ground shipment. Safety Vendor shall immediately notify the COR of any changes from procedure modification, recall modification, recall notification or any changes that will affect the performance of the applicator according to FDA regulations. Test Performance All test and procedures must comply and be approved by the FDA All test, procedures, and equipment must perform at manufacturer s specifications, deviations from the performance specifications shall be corrected by the vendor. A warranty is conveyed for 100,000 shocks per refurbishment. A credit shall be received for the portion of shocks that was not able to be utilized. DELIVERABLES/SUPPLIES Costs: The vendor will bill the EPVAHCS a flat rate of $1750.00 per refurbishment of each applicator received by the vendor. The vendor will bill the EPVAHCS the shipment costs associated with shipping the refurbished applicator back to the facility, this cost to be included in the invoice with the $1750.00. The turnaround time for the vendor to refurbish the applicator and to ship the applicator back to the facility is approximately 1 to2 weeks. WORK HOURS AND PERIOD OF PERFORMANCE: 6.1. The following is a list of U.S. Government holidays. If the holiday falls on a Saturday, the proceeding Friday is observed as the holiday; if the holiday falls on a Sunday, the following Monday is observed as the holiday and any other day specifically declared by the President of the United States to be a national holiday. HOLIDAY DATE New Year s Day Jan 1 Martin Luther King s Birthday 3rd Monday in Jan President s Day 3rd Monday in Feb Memorial Day Last Monday in May Independence Day July 4 Labor Day 1st Monday in Sep Columbus Day 2nd Monday in Oct Veterans Day Nov 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25 6.2. PERIOD OF PERFORMANCE: Contract shall have a base year with four (4) option periods. Costs per Test Purchase Agreement will be in effect for 365-day period of a contract year. The period of performance shall reflect as follows: Base Year May 20,2020 May 19, 2021 Option Year 1 May 20,2021 May 19, 2022 Option Year 2 May 20,2022 May 19, 2023 Option Year 3 May 20,2023 May 19, 2024 Option Year 4 May 20,2024 May 19, 2025 PERSONNEL: The contractor shall provide in writing the name and phone number of personnel within (10) ten calendar days of the award of the contract. The contractor s personnel shall correspond with the COR on a regular basis to discuss any problems that the contractor or contractor s personnel may be experiencing during the performance of this contract. Unresolved problems shall be referred to the Contracting Officer for resolution. Government point of contact (POC). The COR shall be the Government s POC. If required, the COR shall be designated in writing to the Contractor and the scope of authority shall be set forth therein. Contractor shall respond only to calls from COR or a designated representative from the Medical Center. 7.3. SPECIFICATIONS: Contractor shall help with any user questions or issues that are hardware support for physical equipment. The contractor shall provide all labor, equipment, supervision and expertise, to provide maintenance services for the equipment list within the Statement of Work. 7.4. SECURITY STATEMENT: The vendor will NOT have remote Access to the system. The Vendor and all VA employees are required to immediately report any security violations to the Information Security Officer. No other security statements are required. ACRONYMS AND DEFINITIONS: Contracting Officer (CO). A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government. Contracting Officer s Representative (COR). An individual designated in writing by the Contracting Officer to act as an authorized representative of the Contracting Officer to perform specific contract administrative functions within the scope and limitations as defined by the Contracting Officer. RECORDS: All records (administrative and program specific) created during the period of the contract belong to EL Paso Veterans Affairs Health Care System (ELPVAHCS) and must be returned to EL Paso Veterans Affairs Health Care System (ELPVAHCS) at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1. 9. Equipment Ownership. 9.1. Title to equipment shall remain with the contractor until a satisfactory inventory and inspection is completed by Contractor, COR and Biomedical Engineering personnel. Upon approved inspection, title, equipment, accessories and ownership shall be released to EL Paso Veterans Affairs Health Care System (ELPVAHCS). 10. Limited Warranty. 10.1. All equipment listed to the attached quote, shall be fit and sufficient for the purpose intended as set forth in the user manuals; and merchantable, of good quality and free from defects in materials or workmanship; for a period of one (1) year from the date of the first invoice under this agreement. The contractor shall provide a minimum of one (1) year warranty. The warranty will begin upon date of acceptance. 11. TEST EQUIPMENT: The Contractor shall provide the ELPVAHCS, upon request, a copy of the current calibration certification of all test equipment which is to be used by the Contractor on ELPVAHCS's equipment when requested by the ELPVAHCS. Test equipment calibration shall be traceable to a national standard. The Contractor shall present any removable media (i.e. USB or DVD/CD device) required for performing the work to Biomed to be scanned with an anti-virus program running current virus definitions. 12. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The Contractor's FSEs shall wear visible identification at all times while in the building of the ELPVAHCS. It is the responsibility of the Contractor to park in the appropriate designated parking areas. The ELPVAHCS shall not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the ELPVAHCS. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. 13. QUALITY ASSURANCE SURVEILANCE PLAN (QASP): COR shall use surveillance methods listed below in the administration of this QASP. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.) COR shall periodically review major aspects of the PWS to include response time, quality of services provided, and equipment uptime. COR shall utilize direct observations both from the COR, as well as those of the using department or section to ensure a full 360 degree review of the level of service provided. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections shall be unscheduled, as required.) COR shall routinely inspect service records supplied by vendor with using service to ensure quality of service and positive customer interaction. COR shall periodically monitor interaction of vendor with using service to ensure services are provided timely, efficiently, and meet the customer s needs. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.) COR shall routinely engage customers in discussions regarding services rendered and ensure that all communications from the vendor are professional. COR shall review customer complaints regarding system maintenance, downtime, and general communication with vendor, to ensure vendor is aware of any situations where a high-quality of service may have been compromised.