LSJ - Immucor - WCS.pdf

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C244-23-AP-0050 PR/2237 Number: 693-23-1-050-0005

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 460, located at 1601 Kirkwood Highway, Wilmington, DE 19805, in support of VISN 04 Wilkes-Barre VA Medical Center at 1111 East End Blvd, Wilkes-Barre, PA 18711.

2. Description of Action: The Wilkes-Barre VA Medical Center has a need to purchase Blood Bank reagents to provide for Transfusion Services.

Order against: FSS Contract Number: V797D-70110

Name of Proposed Contractor: Immucor, Inc.

Street Address: 3130 Gateway Drive City, State, Zip: Norcross, GA 30091 Phone: 855-466-8267

3. Description of Supplies or Services:

The estimated value of the proposed action (one-year base period and four (4) one-year options periods).

The Wilkes-Barre VA Medical Center has a need for blood bank reagents which are used for

ABO/ Rh typing, antibody screen, antibody identification, direct antiglobulin testing and crossmatching of blood. All reagents must be FDA approved for patient testing.

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.

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));

5. Rationale/explanation to support cited authority: Pricing was obtained through the VA Federal Supply Schedule (FSS), Contract No. V797D-70110, as well as an informal quote provided by Immucor, Inc. VIP search by NAICS code 334516. Verified Vendor in SAM. FSS pricing has been determined fair and reasonable at the time of award. Immucor, Inc. does not have any authorized distributors and are the only manufacturer and sole distributor and have proprietary rights to the Immucor blood bank reagents.

The standard operating procedures for testing in the Blood Bank are all developed, validated, and written according to Immucor Reagent use. Change of these products would change all protocol and procedures. Not only would the procedures change, but a period of time would exist where the laboratory would need to purchase not only the new products, but the existing products because accreditation standards require that the new testing material would have to be validated by the Blood Bank against what is currently used. It would be labor intensive to switch to a different manufacturer due to an extensive validation period with new reagents. The validation could only be done after new procedures were developed and written. Additionally, training of all technologists would need to occur once the material is validated.

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.

PREPARED BY:

YAZMIN ALVAREZ WILLIAM C. SCHLOBOHM

NCO 4, Contract Specialist NCO4, Branch Chief – Services 6

William C.

Schlobohm 193444

Digitally signed by William C.

Schlobohm 193444 Date: 2022.10.19 14:46:09 -04'00'

YAZMIN ALVAREZ

1571591

Digitally signed by YAZMIN

ALVAREZ 1571591

Date: 2022.10.20 07:44:31 -04'00'