SSJ - V500 Ventilator PM.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over MPT but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, VISN 22, San Diego Medical Center.

2. Discription of Services: Services are for scheduled preventive maintenance visits and unscheduled repairs on the following government owned surgical equipment: twenty (20) Dräger Evita Inifinity V500 systems and it’s components.

The total estimated value of the acquisition is and it’s for one year only.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Draeger is the only source that provides service maintenance and repairs for the listed Government-Owned equipment due to the proprietary nature of this equipment.

Draeger has patent rights and proprietary ownership of its products, parts, and services and does not authorize third parties to service its equipment. The use of an unauthorized Draeger technician or non-manufactured Draeger part could lead to equipment failure or malfunction, possible patient injury or death, lawsuits against the hospital and potential loss of hospital accreditation. This utilization of such untrained and uncertified sources would present a significant liability and risk to the Government.

The equipment referenced in section 3 above is highly specialized, anesthesia units used to sedate and ventilate patients during surgery. Each piece of equipment item is classified, by the FDA, as a Class 2 medical device unit and must adhere to rigid control standards established by the equipment manufacturer. Equipment must be maintained, tested, and inspected according to manufacturer specifications. Accreditation Association for Ambulatory Health Care requires that the hospital maintain records of equipment testing and maintenance in order to maintain accreditation. Anesthesia units must pass daily function tests before they can be used in surgery.

The Government is unwilling to utilize unauthorized 3rd parties for maintenance or repair services. The use of an unauthorized technician or non-manufactured Draeger part could lead to equipment failure or malfunction, possible patient injury or death, lawsuits against the hospital and potential loss of hospital accreditation. This utilization of such untrained and uncertified sources would present a significant liability and risk to the Government.

Additionally, if anesthesia equipment malfunctions, the surgery department would not be permitted to perform surgery as scheduled, which would lead to a cancellation.

4. Description of market research conducted and results or statement why it was not conducted:

The Government first reviewed Draeger’s website at https://www.draeger.com and GSA schedule contract to determine if there are any small business resellers or dealers authorized to perform services on Draeger equipment. The website did not contain any information. The GSA

ELIZABETH

RATCLIFF 3333659

Digitally signed by ELIZABETH

RATCLIFF 3333659

Date: 2022.08.17 16:21:19 -07'00' 08/17/2022