Justification and Approval Lecia Reagents and Consumables MEDVAMC.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C256-22-AP-4667

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 16, located at

5075 Westheimer Road, Suite 750, Houston, Texas 77056 in support of VISN 16 Michael E. DeBakey VA Medical Center (MEDVAMC) at 2002 Holcombe Blvd. Houston, Texas 77030. 2237: 580-23-1-026-

2. Nature and/or Description of the Action Being Processed: This procurement is for Leica Immunostainer Reagents and Consumables to be used at the MEDVAMC in Houston, Texas in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR

13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This procurement will result in an unrestricted solicitation issued on a brand name only basis for a base period of 12 months with four (4) additional, 12 month option periods for the delivery of quality-stained slides used in evaluation and interpretation for Histology in Pathology and Laboratory Service. This is for a new requirement and award of a Firm-Fixed Price contract.

3. Description of Supplies/Services Required to Meet the Agency�s Needs: The MEDVAMC located in Houston, Texas, require the Brand Name procurement of Leica Immunostainer Reagents and Consumables for the Pathology and Laboratory Service, Histology Department. The VA already owns two (2) Leica Immunostainer instruments from a previous purchase that are proprietary in nature and is currently in use at MEDVAMC. The reagents and consumables are required to enable pathologists with information in determining accurate and timely patient diagnosis while performing Immunohistochemical staining of Veteran patient�s tissue samples. The Histology Department at the MEDVAMC has a continuous need of Leica Immunostainer Reagents and Consumables as the supplies are highly interactive with a fully automated system which enhances safety and establishes critical efficiencies in the Histology Department. Tentative Base Period of Performance (PoP) for delivery beginning on December 1, 2022 � November 30, 2023.

Option Period 1: December 1, 2023 � November 30, 2024 Option Period 2: December 1, 2024 � November 30, 2025 Option Period 3: December 1, 2025 � November 30, 2026 Option Period 4: December 1, 2026 � November 30, 2027

The total estimated value with Options:

Item No.

Part No. Description: Qty Unit

1. DS9800 Bond Polymer Refine Detection (includes yearly service costs)

35 EA

2. AR9222 Bond Dewax Solution 30 EA

3. AR9961 Bond TM Epitope Retrieval 1-1L 30 EA

4. AR9640 Bond TM Epitope Retrieval 2-1L 30 EA

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 3 of 6

53. PA0088 7ml CD138 Bond RTU Primary 1 EA

54. PA0473 7ml CD15 (MMA) Bond RTU Primary 1 EA

55. PA0169 7ml CD23 Bond RTU Primary 1 EA

56. PA0790 7ml CD30 (JCM182) Bond RTU Primary 1 EA

57. PA0250 7ml CD31 Bond RTU Primary 1 EA

58. PA0212 7ml CD34 Bond RTU Primary 1 EA

59. PA0042 7ml CD45 Bond RTU Primary 1 EA

60. PA0273 7ml CD68 Bond RTU Primary 1 EA

61. PA0183 7ml CD8 Bond RTU Primary 1 EA

62. PA0387 7ml E-Cadherin BondRTU Primary 1 EA

63. PA0026 7ml GFAP Bond RTU Primary 1 EA

64. PA0435 7ml NSE Bond RTU Primary 1 EA

65. PA0299 7ml Synaptoph Bond RTU Primary 1 EA

66. PA0414 CD31 (PECAM-1) 1 EA

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The MEDVAMC intends to procure all reagents, related stains, antibodies, and consumables for quality diagnostic staining of processed patient tissues. This brand is required to maintain safety and critical efficiencies necessary in order to continue providing services to our Veterans at the MEDVAMC. Due to the proprietary nature of the chemicals and the two VA owned Leica Immuonstainer instruments from a previous purchase that is currently in use at MEDVAMC the only known manufacturer of such instrument, reagents and consumables is Leica Microsystems, Inc. the Original Equipment Manufacturer (OEM) of the Leica Immunostainer Reagents and Consumables. The reagents and consumables is only compatible for use with the VA owned equipment and the instruments are manufactured by Leica Microsystems, Inc. The Leica Immunostainer Reagents and Consumables can be obtained by an approved distributor (see paragraph 10) in accordance with FAR 6.302-1(c)(1) for application of Brand Name.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Vendor Information Pages (VIP) was queried utilizing NAICS 334516. Notice of Intent to Sole Source (36C25622Q1452) was posted to the government point of entry (GPE) www.sam.gov to notify industry of a sole source award. Additionally, the Small Business Administration (SBA), Small Business Dynamic Search (DSBS) website, Federal Procurement Data System (FPDS), FedData Check and System for Award Management (SAM) were all reviewed for sources and past procurements. Finally the Contract Speicalist (CS), contacted the OEM Leica Microsystems, Inc. and requested potential Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB) and Small Business (SB) sources who could fulfill this requirement.