J_A Redacted-1.pdf

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ)

For Limiting Sources (<SAT)

Acquisition Plan Action ID:_ HEMOROAM 25XL Mobile Blood and Plasma Refrigerators power Backup project

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 15, located at 3450 S. 4th Street Trafficway Leavenworth, KS 66048-5055, in support of VISN 15 VA Health Care System, Emergency Management at 1 Jefferson Barracks Drive, St. Louis, Mo

63125.

The 2237 for this requirement is 657-25-2-8979-0030.

2. Description of Action: The EMPI funds are for a one-time award for HEMOROAM 25XL mobile blood and plasma refrigerators to sustain the cold chain management initiative during electrical power interruptions.

Order against: FSS Contract Number: 47QSWA19D002X

Name of Proposed Contractor: Divine Imaging, Inc Street Address: 21323 Pacific Coast Hwy ste 101

City, State, Zip: Malibu, CA 90265

Phone: 310-579-4000

3. Description of Supplies or Services:

The estimated value of the proposed action is $ 17,200.00.

Roemer HEMOROAM 25XL (BBS100) Portable Massive Transfusion Unit for transport of red blood cells (RBC), plasma, platelets, vaccines, and the apparatus fulfills an integral part in the cold chain management system for temperature-controlled product. The HEMOROAM 25XL (BBS100) is a battery powered cold storage unit with wheels and handles for efficient steering. Payload capacity is 25 liters/26.4 quarts, and 80-to-96-hour battery life.

• This is a new requirement and the HEMOROAM 25XL (BBS100) mobile blood and plasma refrigerators FSS Contract Number 47QSWA19D002X best fits the needs of the facility.

• Research indicates: The FSS Contract Holder Divine Imaging is a Socio-economic Small Business, woman owned WOSB, Disadvantaged Business entity.

VHAPG Part 808.405-6 Limiting Sources Page 2 of 3

Acquisition ID#: ____________

• This is the best price in market, having contacted various vendors and sought informal quotes. Divine imaging INC was also able to offer the item for below the GSA advantage contracted price.

• Comparing the requirements of VASTLHCS EM Committee versus the capacities of various models, we have a decision matrix that includes other models and vendors. This decision is based strictly on capacities and capabilities after researching the market.

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);

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:

The VA St. Louis Health Care System (VASTLHCS) Emergency Management Service Line is requesting Roemer HEMOROAM 25XL (BBS100) as a quickly deployable mobile apparatus which can be transported by any fleet vehicle. The HEMAROAM 25XL can store biological products between 36–46°F (2°C to 8°C) which meets criteria outlined by the Center for Biologics Evaluation and Research (CBER), and Food and Drug Administration (FDA) guidance with biologicals not being frozen. The HEMOROAM 25XL (BBS100) demonstrates thermal distribution and stability in the separate compartments without degradation while under battery power. VASTLHCS does not have an adequate cold chain management system which can be escalated to recover temperature-controlled product. The brand allows the

VASTLHCS incident management team (IMT) an operational capability to fulfill mission essential functions during an emergency and when vendor services are not available.

https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3

Acquisition ID#: ____________

Divine imaging INC offers this below listed market value and below their GSA Advantage contracted price.

The Roemer HEMOROAM 25XL (BBS100) is the only fully mobile and easily transportable apparatus which can be maneuvered by staff without any heavy lifting or manipulation. It is the only unit to have an 80-to-96-hour battery life allowing the VASTLHCS IMT time to plan a response when cold chain management has been compromised. This unit meets the storage capacity to recover the health care system’s allocation of temperature-controlled product in accordance with VASTLHCS Pharmacy Department standards and the FDA.

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.

Israel Armenta Heather Strouhal

Contract Specialist Contracting Officer/Designee

NCO 15 NCO 15

Date: 05/01/2025 Date: 05/02/2025 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-6#FAR_6_303