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65--Notice of Intent -- Electrosurgical/APC Equipment

Active
VA24616N0798Federal

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The Veterans Affairs Network Contracting Office 6 (NCO 6) plans to negotiate a sole source purchase order with PRO-AIM Americas, LLC for the acquisition of five ERBE VIO 3000D Electrosurgical Units and five APC2 argon plasma coagulators, including related parts. This equipment will be delivered to the Salisbury VA Medical Center and distributed to the Charlotte and Kernersville Health Care Centers in North Carolina. The contract will be awarded as a firm-fixed price purchase order under simplified acquisition procedures in accordance with FAR Subpart 13.5. The procurement bypasses competitive bidding based on FAR 13.501(a)(1) and statutory authorities, citing the need for standardization with existing VA equipment to maintain staff familiarity and patient safety. Using the same brand avoids additional training burdens and risks associated with multiple device platforms across facilities. The sole source justification emphasizes that medical personnel are trained specifically on ERBE brand devices, and switching to alternative brands would require extensive retraining and competency reassessments, potentially compromising patient safety. This position is supported by a prior GAO ruling and peer-reviewed research highlighting the importance of standardization in medical technology to minimize risk. The notice invites any capable sources to submit capability statements by a specified deadline but clarifies that the government retains sole discretion over proceeding with this sole source procurement. The overall intent is to ensure continuity, training efficiency, and patient safety through consistent use of established electrosurgical and argon plasma coagulation equipment across the designated VA health facilities.

General Info

Sole source purchase of ERBE surgical units for VA centers to ensure standardization and safety.

Agency

N/A

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

Posted

special-notice

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Organization & Contact Information

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AgencyN/A
ContactsNo contacts available
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Office AddressN/A
ContactsNo contact information available

Full Description

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Veterans Affairs Network Contracting Office 6 (NCO 6) intends to negotiate on a sole source basis with PRO-AIM Americas, LLC (DUNS: 962568338), pursuant to FAR Subpart 13.5, specifically FAR 13.501(a)(1), and Section 4202 of the Clinger-Cohen Act of 1996. The proposed sole source purchase order is for five (5) ERBE VIO 300D Electrosurgical Units, five (5) APC2 coagulators and related parts. Delivery will be made to the Salisbury VAMC for distribution to the Charlotte and Kernersville Health Care Centers. The action will result in the purchase of five (5) ERBE VIO 3000D electrosurgical units, five (5) APC2 argon plasma coagulators and related parts, for delivery to the Charlotte and Kernersville Health Care Centers in Charlotte and Kernersville, North Carolina. A new firm-fixed price purchase order will be awarded. This procurement is being conducted in accordance with FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The sole source procurement is being conducted on the basis of (1) standardization with existing equipment used at the Salisbury VA Medical Center and satellite medical facilities. The equipment is familiar to medical staff and changing brands would unnecessarily increase the risk of patient injury, as medical personnel rotate between facilities. (2) Use of another brand is prohibitive due to concerns related to training. The medical staff is trained on the ERBE brand of electrosurgical/APC equipment and must have their competency affirmed on a periodic basis. Using another brand of equipment will cause the facility to revise its training program and to re-establish competency for all users on multiple devices, in different locations. No competing device is so advantageous as to warrant changing brands and causing the facility to conduct multiple, repetitive training actions to support one device. Standardization for the purpose of ensuring patient safety, with regard to this ESU/APC equipment, was supported under GAO ruling B-411904. Standardization is further supported in the attached peer-reviewed journal article, "Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology." This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Tuesday, April 5, 2016, 6:00PM EST. Interest/capability statements may be sent to Daniel Spaulding (contractor) at contact@example.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.

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