SPECIAL NOTICE
65 -- Notice of intent to Sole source
- Notice Date
- 7/3/2025 11:09:47 AM
- Notice Type
- Special Notice
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- 256-NETWORK CONTRACT OFFICE 16 (36C256) RIDGELAND MS 39157 USA
- ZIP Code
- 39157
- Solicitation Number
- 36C25625Q1113
- Response Due
- 7/14/2025 10:00:00 AM
- Archive Date
- 09/12/2025
- Point of Contact
- Tina Harris, Contracting Officer, Phone: 228-523-5066
- E-Mail Address
-
tina.harris3@va.gov
(tina.harris3@va.gov)
- Awardee
- null
- Description
- STATEMENT OF WORK (SOW) MAKO4 ROBOT Michael E. DeBakey VA Medical Center Program Objective The Michael E. DeBakey VA Medical Center (MEDVAMC) is requesting Stryker Mako 4 System will be utilized. to assist surgeons in performing total joint replacement and spine procedures and to help increase the volume of joint replacement and spine surgeries. The Mako4 system is the only robotic orthopedic technology available that can assist with knee, hip, spine, and shoulder procedures, making it essential for broadening the scope of care provided. By acquiring this equipment, we will be able to offer more comprehensive services to a larger patient population, further enhancing the range of care available within the VA. The robotic platform will enable the surgeons to virtually plan surgical procedures, make dynamic inter-operative changes to the plan, and utilize the robotic arm with haptic boundaries to execute the plan. The implementation of the technology into the service line will be completed with minimal initial time delays and no compromises to patient outcomes both of which are supported by the literature. The Mako4 Surgical System will improve Veteran s access to minimally invasive surgery by making robotic surgery available to more Veterans and expanding the diseases that can be treated minimally invasively. Scope: The contractor shall provide, transport, install, and test all equipment. All equipment and installation must meet manufacturers and VA specifications. The contractor is responsible for any missing parts and components not included in the order to carry out the installation. The contractor shall furnish all supplies, equipment, facilities, and services required for delivery and installation of supplies and equipment. All products must meet all salient characteristics defined in this section: Product must meet all VA security and networking requirements prior to coming onsite. Hardware/software must meet or equivalent to the specs indicated below and must be compatible with MEDVAMC equipment. (Insert line items on Mako4 quote / price) DELIVERY, INSTALLATION, AND IMPLEMENTATION DELIVERY Contractor shall deliver all equipment to the Michael E. DeBakey VA Medical Center, 2002 Holcombe Blvd. Houston, TX 77030. Minimal storage time available in warehouse. Deliver materials to job in manufacturer's original sealed containers with brand name marked thereon. Package to prevent damage or deterioration during shipment, handling, storage, and installation. Maintain protective covering in place and in good repair until removal is necessary. Deliver specified items only when the site is ready for installation work to proceed. Install all equipment to manufacturer s specifications maintaining Federal and local safety standards. Store products in dry condition inside enclosed facilities. Any government requested delayed delivery up to 120 days after initial award delivery date, shall be at no additional cost to the Government. A pre-delivery meeting will be conducted 30 days prior to initial delivery for verification of delivery and installation dates. Delivery and Installation will be coordinated through the COR. INSTALLATION AND IMPLEMENTATION The contractor shall provide installation. The contactor must conduct pre-installation meetings to gather required information for installation. The contractor shall be responsible for all equipment until installed and accepted by the Government. All required equipment shall be fully installed by the Contractor The Contractor shall remove all related shipping debris and cleanup, any construction associated with delivery and installation of the specified items. Contractor shall remove all packaging from the MEDVAMC premises. The Contractor shall be responsible for any damage to the building that occurs due to Contractor error or neglect. Installation must be completed between 7:30 AM to 4:00 PM, Monday through Friday excluding federal holidays. Federal holidays available at the Federal Holiday OPM site. If there is an operational conflict with installation, government will provide 48 hour notice of installation change hours. The contractor shall coordinate all deliveries, staging areas, installations, and parking arrangements with the COR. Upon coordination with COR for installation, the contractor shall inform the Contracting Officer of any problems which may be anticipated about installation, or which will affect optimum performance once installation is completed. Warranty And Support Warranty and support for the equipment will be provided for 5 years upon receipt and acceptance of the equipment. The warranty and support must be provided to cover all components. 4 hours on-site premium support. All hard drives will be VA property and be kept for sanitization SITE CONDITIONS There shall be no smoking, eating, or drinking inside the hospital at any time unless done so in designated dining areas. Period of Performance: The maximum Period of Performance for overall project is 1 year after contract award. The anticipated period of performance for support services from the warranty is at a minimum 1 year from acceptance. Support services begin when physical installation and final implementation of all buildings are complete. Option Year dates will start from warranty end date. INSPECTION AND ACCEPTANCE The Contractor shall conduct a joint inspection with the COR once all equipment had been delivered and installed. The COR shall inspect all phases of delivery and installation and provide a punch list of any and all missing or damaged products. Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. DELIVERABLES User and Service Manuals The Contractor shall provide, at no charge, two (2) complete and unabridged printed copies and one (1) electronic version (CD) of operator manuals, service manuals, electronic schematics, troubleshooting guides and parts lists for each model of equipment purchased to the Contracting Officer s Representative (COR) with delivery of equipment. Additionally, the Contractor free of charge shall provide any upgrades to these documents. These manuals will include all components and subassemblies, including those not manufactured by the Contractor. These manuals and documentation shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment. Deliver all compilation of manufacturer recommended maintenance schedule and operation materials to COR upon completion of installation PROTECTION OF PROPERTY Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor. The Contractor shall perform an inspection of the building(s) and grounds with the COR prior to commencing work. To ensure that the Contractor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Contractor. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and COR is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work. The Contractor shall be responsible for security of the areas in which the work is being performed prior to completion. Contractor shall provide floor protection while working in all VA facilities if needed. All material handling equipment shall have rubber wheels. SECURITY REQUIREMENTS Contractor is responsible for notifying COR for escorting duties prior to arriving at the facility. Contractor personnel shall check in with Facilities management upon arrival and departure each day. All contractor personnel must provide one form of valid picture identification at the time of check-in to receive a visitor s badge. Badges must be always worn above the waist and visible while on the jobsite. All contractor personnel will be escorted to the work area by a cleared member of the contractor (PIV cardholder), or MEDVAMC representative while on the jobsite. All contractor personnel must turn-in their badges at the end of each day. Contractor is responsible for notifying COR for vehicle parking prior to arriving at the facility. All contractor personnel must provide vehicle insurance, registration, and valid driver s license at the time of check-in to receive a vehicle-parking pass. Vehicle parking passes must be always displayed on the front dashboard of the registered vehicle while on MEDVAMC property. Contractor personnel will be allowed to register up to five (5) vehicles only. All contractor personal vehicles will be allowed to park in the designated vehicle parking spaces in the parking lot as advised by the VA Police. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. If the vendor requires a key, a $100 deposit will be required per key. Information System Security/Privacy Language: See Below. No data, on any type of storage device will be removed from this VA location. Information technology security requirements: 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. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract. The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required. SECURITY STATEMENT: Sensitive VA information is not contained within the systems covered by this contract. Biomedical Engineering shall perform virus scans on all removable media prior to use on VA medical equipment. This includes all types of removable media, including media (e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by VA, and media brought in by vendors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program, September 2007 The Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information. During onsite service, the Vendor shall be chaperoned by VA Personnel. However, the vendor shall not be issued a UserID/Password. Non-volatile memory devices, working or non-working, shall NOT be removed from the VA facility until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media. The vendor will not have remote access to complete the repair(s) and preventive maintenance. The vendor shall sign a Business Associate Agreement with the VA. The COR or designee is responsible for the actions of the vendor during the repair. RECORDS MANAGEMENT STATEMENT All records (administrative and program specific) created during the period of the contract belong to Michael E. DeBakey VA Medical Center (MEDVAMC) and must be returned to MEDVAMC at the end of the contract or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21 , 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. End of scope
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- SN07498522-F 20250705/250703230037 (samdaily.us)
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