P03 SSJ - Shamrock -36C24C-20-AP-0002_redacted.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 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: 36C24C-20-AP-0002

1. Contracting Activity: Department of Veterans Affairs, VISN 01, Veterans

Health Administration (VHA) and VA Office of Acquisition, Logistics and Construction (OALC).

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: VHA Office of Procurement intends to execute a sole source Blanket Purchase Agreement (BPA) between Shamrock Scientific Specialty Systems, LLC and VHA. This action is required to obtain Shamrock medical/surgical supplies for nationwide usage under the Medical/Surgical Prime Vendor (MSPV) program.

The VHA manages the United States’ largest integrated healthcare system, providing care at 1,243 healthcare facilities, including 172 medical centers and 1,062 outpatient sites of care of varying complexity (VHA outpatient clinics), serving approximately 9 million enrolled Veterans each year.

The VHA Office of Procurement has issued 483 BPAs with over 74,000 medical/surgical supplies in support of the MSPV program. The sole source BPA award will ensure availability and consistency of medical/surgical supplies with current VHA spend previously sought through a combination of micro-purchase transactions using purchase orders as well as through the previous iteration of MSPV, known as Next Generation (MSPV-NG).

The VHA MSPV program utilizes Prime Vendor (PV) contracts for distribution and supply management services. Facilities order from the MSPV Product List, which is formed by awarded BPAs to the Original Equipment Manufacturers (OEM), suppliers, and authorized resellers of medical/surgical supplies. Any suppliers and resellers who participate in MSPV distribution contracts must be authorized to provide the supplies by the OEM utilizing an Authorized Distributor Letter from the manufacturer. Shamrock is the manufacturer and sole distributor of their medical/surgical supplies.

https://www.acquisition.gov/?q=/browse/far/13

VHAPM Part 813.106 Original Date: 08/30/17

The Supply BPA’s will have $0 in obligated orders. Any Independent Government Cost Estimates (IGCE) will be in reference to the program spend against the MSPV PV contracts, which are obligations against those 3 major contracts.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: PAX Holdings (094294501) is the parent company of Shamrock Scientific Specialty Systems (080530784).

Shamrock is the manufacturer and only distributor of the required products.

Shamrock is a leading innovator in labels and forms for healthcare, laboratory, pharmacy, and research. The medical labels manufactured by Shamrock differs from a standard product label. These are designed specifically to withstand a hospital environment and to provide any relevant data that doctors, nurses, and other medical professionals may need to know about equipment, medicine, or other tools of the trade. Equipment is often shuffled constantly throughout these facilities, requiring the need for durable and high-quality labels. The U.S. Food and Drug Administration (FDA) mandates medical devices and equipment display a medical label communicating important data in compliance with industry regulatory requirements. Medical labels also carry unique device identifiers (UDI) for identification of medical equipment, safety information, device rating plates, compliance and regulatory identification symbols, and other information necessary for hospital use. The labels supplied by Shamrock Scientific Specialty Systems, LLC are uniquely designed to withstand sterilization, cleaning solvents, and other challenges typical of a medical environment. As one of VHA’s primary OEM suppliers of medical/surgical supplies for the current Medical Surgical Prime Vendor (MSPV) Next Generation program, Shamrock has a proven record of supporting VHA needs. The list Shamrock supplies in Attachment A were previously sought through a combination of micro-purchase transactions using purchase orders as well as through the previous iteration of MSPV, known as MSPV-NG. Market Research support that there are no distributors for the item listed in Attachment A other than Shamrock Scientific Specialty Systems for this requirement.

4. Description of market research conducted and results or statement why it was not conducted: A sources sought was submitted in February 2019 by the VA Office of Small and Disadvantaged Business Utilization (OSDBU) to identifying potential manufacturers of consumable medical supplies. Shamrock Scientific Specialty Systems, LLC responded to the Request for information (RFI) and identified their company as the manufacturer of one or more items in the medical documentation category.

The Dynamic Small Business search was queried on January 24, 2022 utilizing NAICS 339113 - Surgical Appliance and Supplies Manufacturing to search for capable, small businesses concerns. The search produced approximately 4000 small businesses concerns. However, results from the research did not locate any

VHAPM Part 813.106 Original Date: 08/30/17 small businesses that were manufacturers of the required medical supplies found in Attachment A.

Per the Department of Veterans Affairs Acquisition Regulation (VAAR) Sections 810.001-70 & 810.002, The Vendor Information Pages (VIP) was queried on January 24, 2022 utilizing NAICS 339113 to search for capable, verified Service- Disabled Veteran-Owned Small Business (SDVOSB) & Veteran-Owned Small Business (VOSB) concerns. The VIP search produced 551 SDVOSBs and VOSBs businesses in this NAICS. Although these SDVOSBs and VOSBs vendors were discovered through the VIP search, the items found in Attachment A were unable to be supplied by SDVOSBs, or VOSBs. The Government will synopsize this requirement using a sole source notice of intent for the proposed acquisition, total small business set-aside on beta.SAM.gov.

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.

Princess Speight Date Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466

VHAPM Part 813.106 Original Date: 08/30/17

Attachment A

Item# Description Manufacturer Part#

1 SYRINGE ID MIDAZOLAM 5 MG/ML ORANGE PRECUT

LBLS 1/RL 500/EA

SA-219-PRE

2 LABEL,MEDICAL,ANESTHESIA DRUG SYRINGE,WHITE

WITH BLACK/RED PRINT,WITH PEN,10 LABELS PER

SHEET,STERILE,SPECIAL ORDER

SORS-SPC-10

3 ANESTHESIA DRUG SYRINGE LABELS 1/2 X 500 ORANGE

BLACK INK MIDAZOLAM MG / ML / EXP. DATE EXP.

TIME : INT.

SA-212-EXP-PRE

4 ANESTHESIA DRUG SYRINGE LABELS 1/2 X 500 BLUE

BLACK INK FENTANYL / 50 MCG / ML REMOVABLE

SA-2420

5 ANESTHESIA DRUG SYRINGE LABELS 1/2 X 500 BLUE

BLACK INK FENTANYL 50 MCG / ML / EXP. DATE EXP.

TIME : INT.

SA-2420-EXP-PRE

6 ANESTHESIA DRUG SYRINGE LABELS 1/2 X 500 WHITE

BLACK INK / EXP. DATE EXP. TIME : INT.

SA-3216-EXP-PRE