36C25925Q0079.docx

Brainlab ExacTrac System service for the Oklahoma City VA Medical Center (OKCVAMC)

DISCLAIMER

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

BrainLab ExacTrac System service for the OKCVAMC base + 4 contract

PURPOSE:

Veterans Affairs requires a contractor to provide continued support and service of the Brainlab Exactrac system at the Oklahoma VA Health Care System. Services are to be performed in accordance with this PWS and to OEM standards, with the intent of ensuring the equipment operates as the original manufacturer intended, uninterrupted (95% uptime), in a cost-effective, efficient manner, contributing to the VA Mission.

Services are required on the government-owned systems listed in this PWS for the period of performance and at the location outlined in this PWS.

This Contract will be a non-personal services contract. The Contractor, its employees, agents and subcontractors shall not be considered government employees for any purpose. Contractor shall furnish all labor, materials, parts, equipment, tools, transportation, and supervision to provide services in accordance with this Performance Work Statement (PWS).

BACKGROUND:

Equipment: The following systems of equipment require service under this contract. This includes sub-systems, components, software, hardware, and parts.

Equipment Description

PMI Number

TASKS AND REQUIREMENTS

Performance and Repairs: All work performed shall be in accordance with manufacturer’s specifications, including but not limited to adjustments, calibrating, cleaning, lubricating, testing, disassembly, checkout, replacement of parts, etc. required to keep the equipment in operating condition. Contractor must guarantee 95% up time for the equipment. Contractor shall guarantee that all equipment covered by this contract shall be in optimum working condition at the completion of each contracted Period of Performance. Contractor will make every attempt to maintain and repair equipment on-site within a reasonable time, unless local environment prohibits on-site attendance. Failing this, contractor will provide substitute equipment in the event a repair continues beyond the reasonable time frame.

A reasonable time frame ensures the VA mission continues uninterrupted with no loss, damage or suffering to VA patients and resources.

Preventive Maintenance: Contractor shall provide periodic preventive maintenance service on equipment within the interval(s) set by the OEM (ie, Annual, Semi-Annual, Quarterly), in scheduled month of each contracted Period of Performance, including all work between Standard Business Hours, weekend hours, and non-standard hours, and arranged through the COR. The contractor shall work with the COR, Surgery service and Sterile Processing Service to not disrupt patient care by scheduling PM visits in advance. The visits will include equipment verification by an OEM-trained technician. Before the expiration of each period of performance, the contractor shall provide the COR with a report certifying the equipment listed in this PWS has been calibrated to O.E.M. standards not less than OEM recommended interval(s) during the contract period. All parts shall be O.E.M. standard or certified.

Software Updates: Contractor shall provide any software updates, as they become available, for all equipment, at no additional cost. All software changes made become the property of the VA.

Modifications: If contractor or external hazard assessment/notification by the FDA, NCPS, or CEOSH determines that a modification is necessary to address safety concerns or reliability, installation and modification will be performed at no additional charge.

Parts: As part of the OEM-standard of service required on this contract, contractor must provide unique and/or high mortality replacement parts. All parts will be O.E.M. recommended parts. Contractor must provide repair services on batteries and handpieces, at no additional cost to the government. This includes provision of replacement/loaner parts and shipment costs, such as loaner handpieces. To maintain continuity of patient care, contractor must ship replacement/loaner handpieces overnight to the VA within 48 hours of receipt of notice by the VA that a hand piece needs to be repaired due to normal wear and tear. Once the loaner is received by the VA, the VA will ship the government-owned hand piece to the contractor.

If the government-owned hand piece is not able to be repaired the contractor must return the broken handpiece to the VA with written notification of what prevented the repair and the issues causing the part not to function the way the OEM intended.

QUALITY

Conformance Standards Contractor shall ensure that their services, staff and equipment used in the performance of this contract conform and comply with the latest industry service standards, information, guidance, regulations and publications of the following:

1) AAMI-ANSI ST-79:2010 Part 7.7 standards (Servicing and Repairs of Devices in the Health Care Facility). This can be obtained at http://www.aami.org/publications/standards/st79.html

2) IAHCSMM - International Association of Healthcare Central Service Materiel Management

3) US FDA – US Food and Drug Administration

4) CDC – Centers for Disease Control and Prevention

5) CDRH – Center for Devices and Radiological Health

6) ISO (As a minimum: ISO 9001:2008 Certification and ISO 13485:2003 certification (medical devices))

7) ASQ – American Society for Quality

8) UL – Underwriters Laboratories

9) OSHA – Occupational Safety and Health Administration

TECHNICAL QUALIFICATIONS and PERSONNEL STANDARDS

Calibration of Vendor’s Equipment: Contractor must provide the COR with certification attesting that all gauging and measurement equipment used to check and calibrate the subject items of equipment has been calibrated either according to the manufacturer’s specifications or within the last twelve months against a standard that is traceable to the National Bureau of Standards.

Qualifications of Contractor OEM-Trained Technicians: Contractor shall document, in writing, their experience in working on the identical make and model equipment listed in this PWS as well as the qualifications of individuals who will work on the equipment. Where the PWS requires OEM-trained technicians, demonstration of this will also be required in the documentation.

BRIEF SCOPE OF WORK

(This is for information only)

IMPORTANT NOTE: This Sources Sought is for information only (to determine the socioeconomic status of interested companies). No award will be made off of this posting.

LIMITATIONS OF SUBCONTRACTING: The Limitations of Subcontracting may or may not apply to a resulting solicitation from this Market Research. Vendors are advised to familiarize themselves with Federal Acquisition Regulation parts 19.505(a)(2) and 19.505(b)(1) as it pertains to subcontracting limitations. Vendors are also advised to familiarize themselves with 13 CFR 125.6 and the penalties described in this regulation.

Please communicate via e-mail to jeffery.eller@va.gov by 3:00PM, 11/20/2024 as to your company’s interest and ability to perform service per this brief Scope of Work.

If interested, please provide the following:

1. Please state your company’s business size as related to NAICS code 811210:________________

2. As per the Limitations of Subcontracting: (see FAR 19.505)

a. As Primary Contractor: what % of “Total Contract Value” will you retain?___________

b. If using a Subcontractor: what % of “Total Contract Value” will go to them?__________

3. Please provide SAMs Unique Entity Identifier number:_____________

4. If you have an FSS/GSA contract that includes this service:____________

5. Provide FSS/GSA contract number if applicable:________________

IF YOU ARE NOT INTERESTED, NO RESPONSE IS NECESSARY