S02 Brand Name Justification - CPET_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

BRAND NAME ONLY

Acquisition Plan Action ID: 36C244-23-AP-4767

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 4, in support of

VISN 4 VA Pittsburgh Healthcare System (VAPHS) at University Dr. C, Pittsburgh PA 15213.

PR #: 646-23-4-046-0160

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

VAPHS requires a one-time purchase of the MGC Diagnostics Mobile Ultima CardiO2 System package including the Ultimate Cardio2, wireless ECG, exercise flow volume loop, bronchial provocation, and query database software, cycle ergometer, and treadmill. The equipment will be used for cardiopulmonary exercise testing at the University Drive campus, Research Building. The cardiopulmonary functioning will be used to assess cardiorespiratory fitness in patients with heart failure, COVID, and other physical impairements, and to assess related therapeutic interventions.

The estimated value of the proposed action is

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The MGC Ultima CardiO2 system is unique in its integration of several functions required by VAPHS physician researchers into a single machine. MGC has distinctive attributes in data analysis and software, which will achieve uniformity of testing equipment and ensure standardization of protocols, training and data.

The MGC Ultima CardiO2 system also provides reliability and flexibility. It has been relied on consistently, as evidenced by its use at the University of Pittsburgh and prior VA purchases at VA Pittsburgh and VA Boston. It can be used for both research and clinical applications. While the equipment is slated to be used in the research facility, it can easily facilitate clinical applications if it were to become a programmatic goal. The equipment also has the superior capacity to measure ventilatory measures and ECG telemetry during exercise in ways that will accommodate current and future needs. It matches equipment used in Pulmonary Medicine, expanding its value even further.

The MGC Ultima CardiO2 is especially suited to our research priorities. In research applications, it is essential for the Principal Investigator to achieve uniformity of testing across trials and avoid methodologic imprecision. In our case, MGC equipment is already being used at University Drive, Heinz Division, and University of Pittsburgh campuses. Purchasing MGC equipment will create continuity and enable relative ease in standardizing protocols, training, and data across multiple campuses.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

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

Four other CPET manufacturers and models were reviewed by the physician researcher using this equipment. All, except one, are designed primarily for use by a clinician, with limits on how testing can be conducted and how data can be displayed. In other words, with the emphasis on simplification to meet the needs of clinicians, the capacities of most of the options listed are inherently limited. The one piece that is relatively more applicable to research and clinical work is

However, the physician researcher has used portable CPET equipment in a prior study, and found it highly unreliable, with frequent breakdowns and repair issues.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

ANDREA

BUCKLEY

Digitally signed by

ANDREA BUCKLEY

Date: 2023.08.31 15:59:45 -04'00'