Draft SebiaFY24_JA Sole Source _____ Electrophoresis Testing_with KO review changes (1)_Redacted.pdf

Control #: 23-RHCO-C-455 Contractor: Sebia, Inc.

Program/Equipment: Electrophoresis Testing

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

APR 2021

Sole Source Justification and Approval Review Document Under FAR 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: The Department of Pathology and Area Laboratory Services (DPALS) seek to establish a cost-per-test (CPT) agreement for a fully-automated serum/hemoglobin electrophoresis analyzer systems (inclusive of instruments, ancillary equipment, maintenance, services, repairs, support, parts as required in order to maintain the systems in optimal operating condition, and any installation and removal, at no extra cost to the Government to support the Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas.

Authority: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items"

Amount: $1,982,689.34 (Base + Four (4) Option years)

Base Period (1 October 2023 – 30 September 2024):

Option 1 (1 October 2024 – 30 September 2025):

Option 2 (1 October 2025 – 30 September 2026):

Option 3 (1 October 2026 – 30 September 2027):

Option 4 (1 October 2027 – 30 September 2028):

Prepared by:

Typed Name: DSN:

Title: Chief, Core Laboratory_______ Date: 21 June 2023

E-mail: __________________________

Contract Specialist:

Typed Name: DSN:

Contracting Officer:

Typed Name: DSN:

CUI//CP-PROCURE

(Source Selection information - See FAR 2.101 and 3.104-4)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Joint Base San Antonio Health Contracting Branch (JBSA HCB), Medical Readiness Contracting Office, West (MRCO-W) US Army Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas.

2. Description of Action: The Brooke Army Medical Center – Department of Pathology and Area Laboratory Services request the purchase of electrophoresis reagents and consumables on a cost-per-test agreement via a firm fixed price contract for the Department of Pathology and Area Laboratory Services (DPALS), Brooke Army Medical Center (BAMC). The Government projects award before 30 September 2023, with performance to start 1 October 2023; award will be subject to the availability of Defense Health Program, (DHP) FY24 funds. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

Name of Proposed Contractor and Address:

SEBIA, INC.

1705 CORPORATE DR STE 400

NORCROSS GA 30093-2991

3. Description of Supplies/Services: This requirement is a follow-on to the current contract of W81K00-18-P-0382 with Sebia, expiring 30 September 2023. This contract will ensure essential serum/urine and hemoglobin electrophoresis testing supporting Referral testing from the Military Health system and BAMC Hematology/Oncology service with diagnostics for major chronic diseases diagnosis and monitoring and screening for protein abnormalities, for the Department of Pathology & Area Laboratory Services (DPALS) Reference Laboratory at the Brooke Army Medical Center (BAMC), Fort Sam Houston TX.

For this requirement, BAMC will establish a CPT arrangement, wherein the end user (e.g. hospital) pays a “per test” price and runs the tests in-house, and all consumables, controls, analyzers/equipment, and any service necessary to maintain that equipment are provided by the vendor, who retains ownership of the equipment. The CPT agreement will include electrophoresis analyzer systems (inclusive of instruments, ancillary equipment, consumables, controls, maintenance, services to support the Electrophoresis Testing at the Reference Laboratory at BAMC.

Electrophoresis Testing is a laboratory method used to separate proteins based on their electrical charge, size or shape. In conjunction with the other laboratory results and clinical information, electrophoresis testing is used to identify patients with protein disorders. (1) Hemoglobin electrophoresis is used to screen blood samples for hemoglobin abnormalities. (2) Serum protein electrophoresis is used to identify patients with multiple myeloma and other serum protein disorders. (3) Urine protein electrophoresis is performed to screen urine for monoclonal proteins and to determine renal damage patterns. Clinicians rely on these results to ensure timely diagnosis of genetic disorders and malignancies. Failure to provide testing would delay diagnosis and timely treatment of malignancies.

Delivery Period: 1 October 2023 to 30 September 2028

Amount: $1,982,689.34 (Base + Four (4) Option years)

Base Period (1 October 2023 – 30 September 2024):

Option 1 (1 October 2024 – 30 September 2025):

Option 2 (1 October 2025 – 30 September 2026):

Option 3 (1 October 2026 – 30 September 2027):

Option 4 (1 October 2027 – 30 September 2028):

NOTE: As a supply contract, FAR 52.217-8 is not available for use.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority exceeding the simplified acquisition threshold for simplified procedures for certain commercial items.

5. Reason for Authority Cited: The instrumentation must be able to have fully automated discrete random-access capabilities; be able to store regents at Food and Drug Administration (FDA) storage levels; be capable of barcode identification; be able to print patient results as one per page; have the ability to interface with MHS-Genesis and be Risk Management Framework (RMF) and Health Insurance Portability and Accountability Act (HIPAA) compliant. Only 1 vendor is authorized by FDA to provide the cost-per test arrangement for a fully automated clinical electrophoresis analyzer.

Only Sebia, Inc can provide all the required reagents, a fully automated electrophoresis analyzer that has the capacity to fulfill the estimated BAMC volume and perform the required testing mentioned above.

Estimated volume of the reagents on a yearly basis are as follows:

Mandatory Tests/Functions and Estimated Volumes

Test Base Option 1 Option 2 Option 3 Option 4

HGB Electrophoresis

(HGBE)

10,784 11,323 11,889 12,483 13,107

Immunofixation Electrophoresis

(IFE)

4,125 4,331 4,547 4,774 5,013

Serum Protein

(SPE)

9,118

9,574

10,053

10,556

11,084

Urine Protein

(UPE)

1,014

1,065

6. Efforts to Obtain Competition: Based on the previous procurement efforts, there were only two vendors who responded to the sources sought notice, one of which was deemed technically unacceptable lacking full automation. Only Sebia, Inc. produces a fully automated platform required for the volume of testing. Due to the limited number of FDA approved automated platforms, no further efforts will be made to obtain competition at this time. Should BAMC continue to have a need for these reagents at the conclusion of the last option period, a sources sought notice will be posted to the GPE to determine if there are any new entrants to the marketplace that are FDA approved. The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was posted on 18 November 2022 with a response date of 30 November 2022. Upon finalization of this Justification and Approval Document, a notice of intent to sole source will be posted to the GPE with the final J&A to be published within 14 days of contract award.

7. Actions to Increase Competition: Should BAMC continue to have a need for this testing beyond the conclusion of FY28, a sources sought notice will be posted to the Government Point of Entry (GPE) to continue to foster competition and ensure fair and reasonable pricing for any future effort.

8. Market Research: Prior to the posting of the sources sought notices, market research was conducted by DPALS personnel in conjunction with contracting personnel to determine the likelihood of other laboratory testing companies being able to provide for the complete requirement. The methods used included internet searches, a review of the College of American Pathologists’ website as well as the General Service Administration schedule for Electrophoresis Analyzers and Reagents. This Market Research was conducted from November 2022 to June 2023. Of the available schedules, only 4 were FDA approved reagents; and only 1 (Sebia) of those 4 can provide necessary reagents/consumables, and fully automated equipment compatible with MHS-GENESIS.

A Sources Sought Notice was posted to https://sam.gov, the official GPE, on 18 November 2022 with a response due date of 30 November 2022 in order to find companies (small and other-than-small) that could provide an FDA Approved fully automated clinical electrophoresis analyzer and all required reagents for the electrophoresis Testing. A response was received from two (2) companies, Helena Laboratories Corporation – (Small Business), and Sebia, Inc. – (Small Business).

Helena Laboratories provided their capability statement and brochures on 29 November 2022 that included their new Nexus platform the “V8 Nexus.” This platform brings a tremendous level of automation to electrophoresis testing. The V8 Nexus is an 8-channel capillary electrophoresis system that fully automates testing for Serum Protein, Immunodisplacement and Hemoglobin testing. The DPALS Technical Evaluator reviewed Helena’s capability statement and brochures and provided their technical evaluation stating that Helena Laboratories Corporation did not meet the requirements for this action. Helena Laboratories were deemed technically unacceptable lacking a fully automated serum/hemoglobin electrophoresis analyzer system that is compatible with the MHS-GENESIS System.

Sebia, Inc. provided their brochures with the Capillary OCTA 3 - fully automated multi-assay analyzer and the Hydrasys 2 Scan- semi-automated multi-assay analyzer on 2 December 2022. The DPALS Technical Evaluator reviewed Sebia’s capability statement and brochures and provided their technical evaluation stating that Sebia, Inc., meets the requirement for this action.

9. Interested Sources: To date, not aware of any other interested sources that have written to express interest in the acquisition.

10. Other Facts:

a. Procurement history.

(1) Contract W81K00-18-P-0382 was issued for a base period of 01 October 2018 – 30 September 2019, plus four (4) twelve-month option periods through 30 September 2023.

(2) Competitive status - This solicitation was issued as a Small Business Set- Aside to maximize competition. Only one offer was received from Sebia, Inc.

(3) Authority previously cited if less than full and open competition was used on the previous acquisition – N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results – N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources – N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys - N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes – N/A

b. Other facts. N/A

10. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: _ Date:

Typed Name: Title:

11. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: Date: _

Typed Name: Title:

12. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on price analysis techniques. As a part of the basis, certified cost and pricing data is not required per FAR 15.403-1(b)(3).

Signature: Date:

Typed Name:

13. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Approval

Based on the foregoing justification, I hereby approve the procurement of Electrophoresis instrumentation and reagents under a cost-per-test arrangement for Brooke Army Medical Center, in the total amount of $1,982,689.34; on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.