P03 Brand Name SIGNED.pdf

MEMORANDUM TO THE FILE

Subj: JUSTIFICATION FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

FOR AN ACQUISITION UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

1. Organization/Line Office:

Department of Veterans Affairs, VISN 22, Long Beach 600 Medical Center VA Long Beach 600. PR 605-20-4-077-0779.

2. Description of Action being approved:

The VA Loma Linda currently has a need for the following products:

Itamar WatchPAT 300 with Itamar Central Plus SBP Sensor

The Itamar WatchPAT 300 with Itamar Central Plus SBP Sensor is a device used to test for Sleep Apnea and which is already being used at the Loma Linda VA. Due to the current COVID-19 pandemic, many of our patients are still unable to come into the facility. To assist our veterans, this equipment is safely shipped to them and then a shipping label is included for the patient to return these devices back to the VA Loma Linda HS. It is very crucial for the Government to get this equipment as soon as possible as this has caused a tremendous back log in patient care.

The addition of these devices to our previously acquired devices and software allows us to meet the needs of our Veterans and not further delay care.

The reduced equipment currently on hand puts more of our Veterans at risk of untreated Sleep Apnea or leaving it undiagnosed. Ongoing or undiagnosed Sleep Apnea has a direct correlation to high blood pressure, heart failure, stroke, diabetes, depression, severe headaches, PTSD, and more.

3. Description of Product, Supplies or Services:

The Itamar WatchPAT 300 with Itamar Central Plus SBP Sensor is a fully validated HSAT device that will assist our efforts in Loma Linda to get more Veterans diagnosed and treated sooner as well greatly reducing travel pay and unneeded stress on our Veterans.

The Itamar WatchPAT 300 includes a unique and proprietary PAT signal which is Peripheral Arterial Tone as a non-invasive measure of the arterial pulsatile volume changes at the fingertip.

Using specific signal patterns, the unique algorithm provides two indices directly to our EXISTING TRM approved and installed Itamar zzzPAT Software which is used in determining the degree of sleep apnea, Apnea-Hypopnea Index (AHI) and Respiratory Disturbance Index (RDI).

The Itamar WatchPAT 300 with Itamar Central Plus SBP Sensor allows us to securely record and diagnose Peripheral Arterial Tone (PAT); Apnea-Hypopnea Index (AHI) and Respiratory Disturbance Index (RDI), Oxygen desaturation index (ODI), Wake/True Sleep Time, REM/Deep/Light - Sleep Stages, Body Position, snoring in a Non-Invasive matter by only utilizing 3 points of contact.

The Home Sleep Test device, WatchPAT 300 with Central Plus SBP Sensor must be compatible with the VA OIT approved Itamar zzzPAT Software already in use at the Loma Linda VA.

Installation and training are not required since the facility has an already established program.

4. An identification of the statutory authority permitting other than full and open competition. (Requesting Office completes with assistance of Contract Specialist)

a. FAR 13.I06-1(b)(1)(i) states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

b. As required by FAR 13.106-3(b)(i), this memorandum explains the limitation of sources for this acquisition, as only one brand name will be solicited for this requirement (or for a portion of the requirement) and the requirement (or portion of the requirement to be sole-sourced) is not expected to exceed the simplified acquisition threshold.

5. Determination for use of other than full and open competition:

(Select all that apply)

A. _ ONLY ONE RESPONSIBLE SOURCE (select a/I that apply):

1. _ RESTRICTIVE RIGHTS. The source has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required.

2. _ EXCLUSIVE LICENSING AGREEMENTS. The item or service is only available from the Original Equipment Manufacturer (OEM), or there is only one authorized distributor or technical representative for the OEM.

3. OTHER REASONS.

B. _X_ BRAND NAME

Manufacturer:

Itamar Medical, Inc.

POC: Andrew Nankas Telephone: 214-907-5528

C. ___ URGENT AND COMPELLING

Justification: The VA Loma Linda Healthcare System already has 20 WatchPAT 300 devices with Central Plus SBP Sensors. The additional devices requested need to be fully compatible with the existing database, software and patient education materials. If a brand other than Itamar WatchPAT 300 devices with Central Plus SBP Sensors were to be purchased, they would not be compatible with the VA Loma Linda existing equipment and software.

A different brand of device will not work with Itamar zzzPAT Software currently in use. In accordance with Directive 6550, software that contains and provides patient’s private information and it has access to the VA servers must be VA OIT approved.

The zzzPAT software is VA OIT approved per Directive 6550. The purchase of this software was made previously and is NOT required at this time.

If a different brand of software is needed it will then have to be approved by the VA Office of Information and Technology.

The VA Loma Linda staff is trained in the use of WatchPAT 300 devices and required software, if a brand other than Itamar were to be purchased it will cost the Government additional funding in training on new equipment.

RESTRICTIVE RIGHTS. Itamar Medical Inc. has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required.

6. Certifications

As the technical or requirement personnel, I certify that the evidence of the supporting data that forms the basis of this justification is complete and accurate.

8/13/2020

X

Signed by: misty R. cobb 145991

MISTY COBB

Respiratory Therapist

Contracting Officer