JA - UC Masimo Brain Function Monitors REDACTED.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 3 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ)

For Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C244-21-AP-2460

1. Contracting Activity: Department of Veterans Affairs, 2907 Pleasant Valley Blvd., Altoona, PA 16602 / PR 595-21-2-480-0062

2. Description of Action: The Lebanon VAMC requires the urgent purchase of four (4) Masimo Sedline Root Brain Function Monitors, three (3) Rollstand Carts, and two (2) boxes each of O3 Regional Sensors/Large, and RD Sedline EEG Sensors.

Order against: FSS Contract Number: V797D-30127, Expiration 2/28/2022

Name of Proposed Contractor: Masimo Corporation Street Address: 52 Discovery City, State, Zip: Irvine, CA 92618-3105 Phone: (800)326-4890

3. Description of Supplies or Services:

The Lebanon VA Medical Center (LVAMC) has a requirement for four (4) Masimo Sedline Root Brain Function Monitors, three (3) Rollstand Carts, and two (2) boxes each of O3 Regional Sensors/Large, and RD Sedline EEG Sensors. Two units will be used in the OR by Anesthesia Staff during surgical procedures and two will be used in the COVID ICU. The units are used to monitor sedation levels, brain function and oxygen levels in patients having surgical procedures or those on a ventilator and intubated.

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

VHAPM Part 808.405-6 Limiting Sources Page 2 of 3

Revision 02 Eff Date: 02/21/2020

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

(FAR 8.405-6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority:

Due to the recent rise in COVID-19 patients at the facility, Lebanon VAMC is in need of (4) four MASIMO Sedline Root Brain Function Monitors to provide higher quality of care in our current COVID-19 ICU for current COVID patients, or those that have residual respiratory issues from a COVID infection. These units will be also be utilized by anesthesia staff to ensure constant monitoring of anesthesia and oxygen levels to appropriately maintain sedation during intubation.

Right now the COVID ICU and OR have no way to measure oxygen levels in the brain or sedation levels via brain activity. The current EEG monitors in use only monitor sedation levels and do not possess EMG filters, leading to a diminished use in partially sedated patients. The Masimo devices measure oxygenation levels in the blood (COVID causes low oxygen blood levels) and the effects of sedation on the brain, and alert staff if a patient is properly sedated or in active distress. These devices also possess an EMG filter which more accurately measures the depth of sedation in a patient, ensuring the patient is not actively in distress. By monitoring both sides of the brain and used simultaneously with the Sedline EEG sensors, the Masimo monitors are able to closely monitor the Patient State Index (PSI), an EEG parameter related to the effect of anesthesia on the brain.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 3

Revision 02 Eff Date: 02/21/2020

6. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Date

Date

Jennifer A. Cutshall, Contracting Officer

One Level Above the Contracting Officer:

JENNIFER A.

CUTSHALL 1458294

Digitally signed by JENNIFER

A. CUTSHALL 1458294

Date: 2021.03.11 08:56:07 -05'00'

Caroline L.

Robinette 135596

Digitally signed by Caroline L. Robinette 135596 Date: 2021.03.11 08:58:47 -05'00'