P03 - FAR 13.5 Sole Source Justification - Over SAT - 36C263-24-AP-3836 - FINAL_Redacted.pdf

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: 36C263-24-AP-3836

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 23, 113

Comanche Rd., Fort Meade, SD 57741 for the Veterans Integrated Service network (VISN), VISN 23 VA Health Care System – all sites.

2237: No 2237 was issued due to this request is to develop an Indefinite Delivery/Indefinte Quatity (IDIQ) contract.

2. Nature and/or Description of the Action Being Processed:

This procurement is for an Indefinite Delivery Indefinite Quantity (IDIQ) contract for Becton Dickinson (BD) Bactec Blood Culture Bottles for with six (6) Ordering Periods totaling five (5) years 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 is a new requirement using a Firm-Fix-Price, Sole Source, IDIQ to Becton, Dickinson & Company (BD), 1 Becton Drive, Franklin Lakes, NJ 07417. There is no other source source of supply/servce that will satisfy agency requirements. Bactec Blood Culture Bottles is proprietary supplies to BD.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Estimated Value: $650,000.00 Max Ceiling

VA Midwest Healthcare Network (VISN 23). VISN 23 has a multi-site requirement for Becton Dickinson and Company’s (BD) Bactec Blood Culture Bottles. The testing is performed on (BD) Bactec instrumentation. Bottles are proprietary to the established equipment. The Government intends to award an Indefinite Delivery Indefinite Quantity (IDIQ) for Becton Dickinson (BD) Bactec Blood Culture Bottles for with six (6) Ordering Periods totaling five (5) years.

Scope:

The Pathology & Laboratory Medicine Service Line in VISN23 desires to acquire Becton Dickinson (BD) Bactec Blood Culture Bottles to perform clinical testing for each of the clinical laboratories located at the following VA facilities:

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The annual quantity is only an ESTIMATE. Volumes may vary during the life of this IDIQ contract.

The Government reserves the right to add additional VISN 23 Lab sites and/or testing kits during the life of this agreement. This will be completed with a Supplemental Agreement between the Government and the Contractor.

General Requirements - The Becton Dickinson (BD) Bactec Blood Culture Bottles must be compatible with and FDA approved to operate on Becton Dickinson (BD) Bactec Blood Culture instrumentation platform. Orders received must be the same lot number per shipment per site for reasonable QC purposes. When used according to manufacturer’s specifications must meet the performance characteristics and quality assessments as defined by the 1988 Clinical Laboratory Improvement Act.

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

VISN 23 has a multi-site requirement for Becton Dickinson (BD) Bactec Blood Culture Bottles. This testing is performed on Becton Dickinson (BD) Bactec instrumentation. Bottles are proprietary to the equipment. The Becton Dickinson (BD) Bactec Blood Culture Bottles must be compatible with and FDA approved to operate on Becton Dickinson (BD) Bactec Blood Culture instrumentation platform.

Orders received must be the same lot number per shipment per site for reasonable QC purposes.

When used according to manufacturer’s specifications must meet the performance characteristics and quality assessments as defined by the 1988 Clinical Laboratory Improvement Act.

Central Iowa, St. Cloud, Sioux Falls, Iowa City, and Black Hills owns their Bactec Blood Culture analyzers. Logistics and Laboratories purchases the blood culture bottles. VA Fargo leases their Bactec Blood Culture analyzer and has a local contract for CPT bottles usage.

VISN 23’s current contract expires 04/30/2025. Not having this contract in place has the potential to significantly disrupt patient care by leading to delays in diagnosis, misdiagnosis, or making the management of patients with infectious diseases more difficult.

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6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Sources Sought was posted to Contracting Opportunities under 36C26324Q1023 from 07/25/2024

– 08/08/2024; yielding zero (0) responses from any interested and/or authorized vendors. This notice provided contractors the opportunity to submit a technical package, that provides clear and convincing evidence that they can meet the Government's requirement. To date, no one has responded.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Fair and reasonable pricing will be determined based on a comparison of historical prices paid for recently awarded VA purchases in accordance with FAR 13.106-3(a)(2)(ii).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Several sources were utilized to conduct market research. They were: National Acquistion Center (NAC), Emergency Care Authization Tool (ECAT), Federal Procurement Data Systems (FPDS), GSA eLibrary, VetCert, and System for Award Management (SAM).

Market Research Findings:

a. Conducted a query on SBA Veteran Small Business Certification (VetCert) searching the vendor’s name Becton Dickinson and Company’s (DP4CNEMUF5F3). This produced zero

(0) results.

b. Conducted a search on FPDS-NG and using keywords “Bactec” “VA”. This produced zero

(347) results to the legal business name of Becton, Dickinson and Company.

c. Conducted a search on ECAT using the item numbers as key words. All five (5) item numbers (442794, 442022, 442023, 442020, 442021) for the requested bottles are available. It has been identified that these bottles listed on ECAT were pulled from the ECAT contract on 09/15/2024 as directed by Mr. James Klutts, Deputy Director, National Pathology and Laboratory Medicine Service. After conducting a review of ECAT on 10- 30-2024, the requested items are still available, but it is unknown how long this will be.

Upon discussions with the Mission Partner, they noted that, “National PALMS is against the use of ECAT or MSPV for laboratory reagents as it poses a clinical risk and patient safety concern. This is a clinical reason why the Mission Partner feels a contract for this procurement would be the best option for the safety of our Veterans in lieu of the usage of ECAT.

d. Searched the VA National Acquisition Center (NAC), using keywords “(442794, 442022, 442023, 442020, 442021)”. These item numbers did not populate during the datamining search.