Justification and Approval___Reagents for Simplexa Reagents--- (KO-KS-COR-Supervisor Signed) (8).Redacted.pdf

CUI//CP-PROCURE Control No: 23-RHCO-C-000032

Controlled by: USAHCA Controlled by: RHCO-C CUI Category: PROCURE

LDC: FED ONLY

POC:

CUI//CP-PROCURE

1. JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: The Brooke Army Medical Center Department of Pathology and Area Laboratory Services requirement is to obtain molecular HSV 1&2 testing compatible with (2) government owned DiaSorin Molecular “Integrated Light Cyclers.”

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: $105,000.00 (Base + Four (4) Options) Base Period (1 October 2022 – 30 September 2023):

Option 1 (1 October 2023 - 30 September 2024):

Option 2 (1 October 2024 - 30 September 2025):

Option 3 (1 October 2025 - 30 September 2026):

Option 4 (1 October 2026 - 30 September 2027):

Prepared by: DSN:

Contract Specialist Date: 20 June 2022 Email:

Contracting Officer: Telephone:

Contracting Officer Date: 20 June 2022 Email:

Technical: DSN:

OIC, Molecular/Immunology Date: 20 June 2022 Department of Pathology and Area Laboratory Services Brooke Army Medical Center Email:

Requirements: DSN:

Chief, Clinical Pathology/Molecular Diagnostics

Date: 20 June 2022 Department of Pathology and Area Laboratory Services Brooke Army Medical Center Email:

Controlled by: RHCO-C CUI Category: PROCURE

Reviews: I have reviewed this justification and find it adequate to support a sole source contract action.

Program Manager:

Typed Name:

Deputy Laboratory Manager Department of Pathology and Area Laboratory Services Brooke Army Medical Center

Signature:

.1

236074672

Digitally signed by

N.1236074672 Date: 2022.08.31 14:30:44 -05'00'

Controlled by: RHCO-C CUI Category: PROCURE

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: Joint Base San Antonio Health Contracting Branch (JBSA/HCB), Regional Health Contracting Office – Central (RHCO-C), US Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas.

2. Description of Action: Purchase of reagents and consumables via firm-fixed-price contract for the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center, JBSA Fort Sam Houston, Texas that are compatible with Government-owned equipment. The Government projects award before 30 September 2022, with performance to start 1 October 2022; award will be subject to the availability of Defense Health Program, (DHP) FY23 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(s) and Address:

Diasorin Molecular, LLC.

3. Description of Supplies/Services: This requirement is a follow-on to the current contract W81K00-18-P-0059 with Diasorin Molecular, LLC. (Diasorin) expiring 30 September 2022. This contract is currently in place to provide testing reagents compatible with (2) government owned DiaSorin Molecular “Integrated Light Cyclers.”

The molecular HSV 1&2 testing are reliable and clinically validated products designed for qualitative and multi-analytic detection of Herpes Simplex Virus 1&2. These real-time Polymerase Chain Reaction (PCR) assays are designed to run on the DiaSorin Molecular “Integrated Light Cycler”. The instrument is controlled by an external computer running the Integrated Cycler Studio Software. Infectious disease assay testing assists clinicians with proper diagnoses to decrease the severity of illness by identifying and assessing the progression of disease, thereby shortened hospital stays, and leading to improved therapeutic outcomes.

The Simplexa® HSV 1 & 2 Direct Kit is a FDA cleared assay for the detection of HSV in Cerebrospinal fluid (CSF), Cutaneous and Mucocutaneous Swab Samples. This test detects and differentiates between HSV 1 & HSV 2 on these sample types. This test is used at BAMC to support patient care to evaluate for HSV. This test will not be used for research.

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

Controlled by: RHCO-C CUI Category: PROCURE

Reagents

QTY

Kit

Unit Price

Test Unit Price

Molecular HSV 1&2 testing 21

Total for the Base Period and each Option Year

Amount: $105,000.00 Base Period (1 October 2022 – 30 September 2023):

Option 1 (1 October 2023 – 30 September 2024):

Option 2 (1 October 2024 – 30 September 2025):

Option 3 (1 October 2025 – 30 September 2026):

Option 4 (1 October 2026 – 30 September 2027):

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 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: Diasorin Molecular, LLC is the only reagent company in the United States that has a proprietary assay for In order to purchase the proprietary r assays in the United States, the individual would have to directly contact Diasorin.

Diasorin does not partner with any outside distributors in the United States. Diasorin is the sole manufacturer and distributor of the reagents and supplies that are compatible with two (2) Government-owned DiaSorin Molecular Integrated Light Cyclers; this system is manufactured by Focus Diagnostics, which is a subsidiary company of DiaSorin Molecular, LLC. The molecular reagent kits offered by Diasorin are compatible with the laboratory instrument; no other cartridges are compatible with the DiaSorin Molecular Integrated Light Cyclers; alternative reagents are different in shape and provided different results. The DiaSorin Molecular Integrated Light Cyclers are still in use as a testing phase by the laboratory; another manufacturer’s reagents would alter the results received by testing and would not be usable for the end product decision-making phase.

Controlled by: RHCO-C CUI Category: PROCURE

The two (2) Government-owned DiaSorin Molecular Integrated Light Cyclers were purchased in September 2015 and the life expectancy for this equipment is ten (10) years. Alternative reagents are not compatible with current instrumentation and would void warranties.

a. A Sources Sought Notice was initially posted to https://beta.sam.gov, the official

Government Point of Entry, on 14 July 2022 with a response due date of 22 July 2022 in order to find companies (small and other-than-small) that could provide reagents to conduct the molecular testing. The Government did not receive a response from any interested offeror. The notice of intent to sole source will be posted to the https://beta.sam.gov for 15 days.

b. Alternatives. There are not any alternatives to Diasorin that would not result in mission failure; other reagents that are not compatible to the Government-own equipment cannot be used, but would cause a significant delay in obtaining test results. Brooke Army Medical Center provides healthcare services to Active Duty and Retired military members as well as their dependents, as mandated by statute. Part of those healthcare services involves performing laboratory tests in order for physicians to make a diagnosis and develop a treatment plan.

6. Efforts to Obtain Competition: No further efforts will be made to obtain competition.

The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was already posted to https://beta.sam.gov; upon finalization of this Justification and Approval document, a notice of intent to sole source will be posted to the GPE - https://beta.sam.gov for 15 days 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 these molecular 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.

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, to include a review of the College of American Pathologists’ website. This Market Research was conducted from March to August 2022.

Controlled by: RHCO-C CUI Category: PROCURE

DiaSorin Molecular, LLC. Provides the Simplexa HSV 1&2 Direct Kit that is compatible with the Government-owned equipment. The Simplexa HSV 1&2 Direct Kit is the only FDA cleared HSV molecular test for CSF, cutaneous and mucocutaneous swab samples, and it is made for clinic use therefore, this vendor meets the requirement for this effort.

As discussed above, Diasorin is the only vendor that can provide the molecular reagents that are FDA approved; developed for patient care and is compatible with the Government-owned equipment.

9. Interested Sources: Other than Diasorin Molecular, LLC, no other sources that can provide all molecular reagents have written to express interest in the acquisition.

10. Other Facts:

a. Procurement History:

i. Contract W81K00-18-P-0059 was issued with a base period of 21 December 2017 – 30 September 2018 plus four (4) twelve-month option periods through 30 September 2022.

ii. Authority previously cited if less than full and open competition: N/A

iii. Summary of previous justification: N/A

iv. The solicitation for the current contract was solicited on a full and open basis yielded only one offeror, Diasorin Molecular, LLC.

v. Unusual patterns: N/A

vi. Significant changes: N/A

b. Diasorin does not have any known distributors or other authorized vendors that could provide the required testing reagents.

(End of page)

Controlled by: RHCO-C CUI Category: PROCURE

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.

Typed Name: Date:

Title: OIC, Molecular/Immunology Signature:

Department of Pathology and Area Laboratory Services, Digitally signed by .15135653

Brooke Army Medical Center I.1513565301 Date: 2022.08.31 14:15:40 -05'00'

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.

Title: Chief, Clinical Pathology/Molecular Diagnostics Signature:

Department of Pathology and Area Laboratory Services, Digitally signed by

LAN.1124023633

Brooke Army Medical Center 1124023633 Date: 2022.08.31 14:21:00 -05'00'

Controlled by: RHCO-C CUI Category: PROCURE

Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based on the independent Government estimate and previous prices paid. As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Title: Contracting Officer Signature:

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

Title: Contracting Officer Signature:

Date: 2022.08.31 22:19:42 -05'00'

1096950213 Date: 2022.08.31 22:20:02 -05'00'