P03.Atch 1 Single Source Justification for SAP under the SAT.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C244-21-AP-4741

1. Contracting Activity: Department of Veterans Affairs, VISN 4, 693 Wilkes-Barre VA Medical Center, Pathology and Laboratory Medicine Service, 1111 E. End Blvd Wilkes-Barre, PA 18711-0030.

PR: 693-22-1-050-0011

2. Brief Description of Supplies required and the intended use/Estimated Amount:

Line No. Product No. Description Qty Price 0001 R01040 Remel CDC Anaerobic Blood Agar 10/pkg 72 $309.60 0002 R01048 Remel CDC Anaerobic Blood Agar w/ PEA 10/pkg 72 $384.48 0003 R01202 Remel TSA Blood Agar (Trypticase Soy Agar) 100/pkg 72 $1,861.20 0004 R01302 Remel Chocolate Agar II (GC) 100/cs 12 $324.96 0005 R01320 Remel Columbia CNA w/5% Sheep Blood 10/pkg 168 $540.96 0006 R01478 Remel HBT Bilayer Medium for Gardenella 10/pkg 24 $433.20 0007 R01552 Remel MacConkey II Agar 100/pkg 60 $1,623.60

R01768 Remel Sabouraud 4% Dextrose Agar pH 5.6 (mycology) Double pour 10/pkg

48 $211.68

R02006

Remel Anaerobic reducible LKV Blood Agar/Bacteroides Fragillis Isolation Agar 10/pkg

72 $1,006.56

B21954

Becton Dickinson Haemophillus Test Medium Agar 10/pkg

24 $310.80

0011 R04050 Remel Mueller Hinton II Agar 150 ml; 10/pkg 12 $86.88 0012 R10320 Remel Jembec System (TM IMP) 10/pkg 24 $205.20 0013 Option Year 1 $7,299.12 0014 Option Year 2 $7,299.12 0015 Option Year 3 $7,299.12 0016 Option Year 4 $7,299.12

Total estimated contract value is $36,495.60.

Brand name requirement for 11 different types of Remel Agar and one (1) type of agar that is manufactured by Becton Dickinson. The Laboratory needs to purchase various types of Microbiology Media or Agar so that culture and sensitivity testing can be performed on various types of specimens submitted to the laboratory. The cultures are to detect bacteria that may be causing an infection in a patient.

VHAPM Part 813.106 Page 2 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

Unique characteristics that limit availability to only one source, with the reason no other supplies can be used: The manufacturer is only one source for 11 out of the 12 items, and that is Remel. The manufacturer of the Haemophillis agar is Becton Dickinson. The brand name of the product is important in laboratory work. Products cannot just be switched out without intense validation to ensure accuracy of testing. The products are also specific to the testing procedures that we perform here at Wilkes-Barre. While brand name for all of the products listed, there are at least two distributors for the products. Change in the manufacturer of the Media used would require validation and quality control studies of at least 30 days as well as the purchase of our current media along with purchase of a new type of media. This is due to correlating the results of both types of products against one another. This all required by Accreditation Standards as well as the CLSI standards. Additionally, the change would require all new standard operating procedures and training of staff that plate the specimens. The required products need to be the brand names listed in this document.

All Microbiology Standard Operating Procedures would need to change if the brand of the media is changed. Validation of the products would need to take place. This minimally a 30 day process.

Therefore, we would even need product for September 1, 2021 rather than October 1, 2021 to validate the new products. While these brand names are required, the media can be purchased from more than one vendor.

All but one of the products must be manufactured by Remel as this is what we currently use and is validated by the Laboratory. The last product is manufactured by Becton Dickinson and is validated by the laboratory. Validation is required by Accreditation standards. Validation of a new product would require overlap of products and 30 days of quality controls. This is costly and takes a great deal of technologists time. The products however, are distributed by (3) different companies that have GSA contracts (although the contract with Cardinal is expiring in July 2022 and we did not get pricing for all the products as they did not send a quote. All pricing for Cardinal is from GSA and not all products are on GSA). Government Scientific submitted a quote, but all pricing is Open Market.

Description of market research conducted and results or statement why it was not conducted:

P&LM is a clinical laboratory that does a wide menu of laboratory testing within our service. Remel Inc. dba Thermo Fisher Scientific Remel Products (OEM) (Large) is the Mfr of Agar Media needed by Wilkes-Barre VAMC P&LM. The Contract Specialist (CS) reviewed the results of recent market research for PO #36C24420F0062 awarded from 10-01-2019 to 09-30-2020 undertaken to meet similar requirements. Confirmed Geo-Med LLC (SDVOSB) .

VHAPM Part 813.106 Page 3 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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VHAPM Part 813.106 Page 4 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Allan Tabliago Ronald Kline Contract Specialist, NCO4 Contracting Officer, NCO 4 Date: 09/09/2021 Date: 09/09/2021

Gregory Wizar Branch Chief, Commodities 2, NCO4 Date: 09/09/2021