Attachment D - LSJ-Signed.pdf

AP# 36C244-25-AP-1344 | Bio-Rad Controls | Altoona

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C244-25-AP-1344

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C244-25-AP-1344

1. Contracting Activity: : Department of Veterans Affairs, Network/Program Contracting

Office 04 , in support of VISN 04, James E. Van Zandt VA Medical Center(JEVZVAMC), Altoona, PA 16602. 2237/PR#: 503-25-3-028-0008

2. Description of Action: The JEVZVAMC Medicine Service (LMS) is requesting the purchase of quality control reagents resulting in a base contract with four (4) one-year options. This is a brand name only request for Bio-Rad Laboratories Quality Control reagents. This procurement will be competed among vendors who can meet this brand name requirement.

FSS Contract Number:

Name of Proposed Contractor: Government Scientific Source Street Address: 12355 Sunrise Valley Dr., Suite 400 City, State, Zip: Reston, VA 20191 Phone: 800-248-8030

FSS Contract Number:

Name of Proposed Contractor: Cardinal Health Street Address: 7000 Cardinal Place City, State, Zip:

Dublin, OH 43017

Name of Proposed Contractor: Branch Medical Street Address: 420 S. 15th Ct.

City, State, Zip: Ridgefield, WA 98642 Phone: 202-424-0940

3. Description of Supplies or Services: The Quality Control (QC) reagents are a concentration of chemical compounds used to ensure that the analyzer is performing correctly thus assuring that the results of patient results are true and accurate. BioRad Controls are needed for quality control testing for a wide range of blood analytes. These analytes are used to aid practitioners in the diagnosis of disease. All testing that is done within the laboratory mandates that QC is performed and found to be acceptable prior to any patient testing can be done.

VHAPG Part 808.405-6 Limiting Sources Page 2 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C244-25-AP-1344

The specific brand name description QC reagents ordered, along with yearly estimated quantities, unit, and total prices are listed in the table below:

Item Description Quantity Unit Price Extended Price

0001 BR 146 CARD

MKR LT PLUS 1

LIQ 6X3ML

26 $212.60 $5,527.60

0002 BR 147 CARD

MKR LT PLUS 2

LIQ 6X3ML

26 $212.60 $5,527.60

0003 BR 148 CARD

MKR LT PLUS 3

LIQ 6X3ML

26 $212.60 $5,527.60

0004 BR 360 IA PLUS

TRI LIQ 12X5 ML

42 $208.60 $8,761.20

0005 BR 397 URINE

CHEMISTRY 1 LIQ

12X10ML

6 $183.20 $1,099.20

0006 BR 398 URINE

CHEMISTRY 2 LIQ

12X10ML

6 $183.20 $1,099.20

0007 BR 544 ETHANOL

AMMONIA 1 LIQ

6X3ML

16 $122.25 $1,956.00

0008 BR 545 ETHANOL

AMMONIA 2 LIQ

6X36ML

16 $122.25 $1,956.00

0009 BR 546 ETHANOL

AMMONIA 3 LIQ

6X3ML

16 $122.25 $1,956.00

0010 BR697

MULTIQUAL

UNASSY 1 LIQ

12X10ML

14 $81.05 $1,134.70

0011 BR698

MULTIQUAL

UNASSY 2 LIQ

12X10ML

14 $81.05 $1,134.00

0012 BR699

MULTIQUAL

UNASSY 3 LIQ

12X10ML

14 $81.05 $1,134.00

The estimated value of the five year proposed action is $184,072.50.

The base year is estimated to be $36,814.50.

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C244-25-AP-1344

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:

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 required QC material must be the brand name Bio-Rad Laboratories. The JEVZVAMC LMS has already validated the use of the listed QC material as a part of the purchase and installation of the Alinity analyzer in FY22. Quality Controls are compatible with JEVZVAMC current test methods on its Abbott Alinity analyzers. The JEVZVAMC laboratory is currently compare their quality control results with those of other laboratories. Verifying proper functioning of their blood analyzer with the Biorad controls and comparing with other samples and aid pract The loss of historical data as well as trends could delay detection of quality control issues that otherwise would have been noticed. Patient testing would not be able to be performed without the Biorad controls. it,.

Due to time and complication as well as costs of validation studies, utilizing another brand of QC reagents that are not compatible with the VA Owned Equipment would be a waste of government funds. It would also be to the disadvantage of the VA to lose its access to peer to peer review of QC data that also ensures validated and accurate results of patient testing.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. 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, Approved by, Christa Stine William C. Schlobohm NCO 4, Contract Specialist - Services 5 NCO 4, Branch Chief-Services 5