JA Sole Source FAR Part 13.5 (SEP 2021) - Redacted.pdf

CUI//SP-SSEL

Control Number: 24-RHCO-C-95

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

SEP 2021

Justification Review Document For Sole Source - FAR Part 13.501*

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

Program/Equipment: Integrated ImmunoChemistry and Immunoassay Analyzer and Reagents. Reynolds Army Health Clinic, Fort Sill, OK (RAHC), Fort Sill, Oklahoma 73503.

Authority: FAR 13.501(a)(1)(ii): sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount: The estimated value of this effort is $2,282,162.20 including all options.

Prepared by:

Typed Name:

Title: Contract Specialist Date: 1 February 2024

E-mail:

Contracting Officer:

Typed Name:

Date Reviewed: KO Review 7 Feb E-Mail: i

Technical and Requirements Representative:

Typed Name:

Title: Chief, Department of Pathology Reynolds Army Health Clinic, Fort Sill, OK

Date:

Controlled by: USAHCA Controlled by: RHCO-C CUI Category (ies): General Procurement & Acquisitions Limited Dissemination Control: FED ONLY

POC:

Immunochemistry and Immunoassay Analyzer and Reagents

Control Number 24-RHCO-C-95

SEP 2021

1 April 2028 – 31 March 2029 $456,432.44

Proposed Total $2,282,162.20

4. Authority Cited: The statutory authority permitting other than full and open competition is 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.

5. Reason for Authority Cited: Ortho-Clinical Diagnostics, Inc. is the only responsible source capable of meeting the Government’s need with two (2) waterless Immunochemistry (1 each) and Immunoassay (1 each) Analyzers, Reagents for a contract performance start date of 1 April 2024.

The Government has a current need in the Department of Pathology, Laboratory Services, RAHC to provide a diverse array of tests that is required to accommodate the potential variety of patients to include basic training personnel, active duty, retirees, and civilians. Current market research to include a sources-sought notice, has not revealed any vendors other than Ortho-Clinical Diagnostics, Inc. who could provide the required analyzers and tests for a 1 April 2024 contract performance start date. The cost of the instruments (to include maintenance), reagents, and consumables are included in the costs of the required tests. Failure to award a contract to another vendor other than Ortho-Clinical Diagnostics, Inc. would result in a lapse in testing, further resulting in potential mission failure in providing health care supplies to the basic training population, military treatment facility and the broad beneficiary population. Ortho-Clinical Diagnostics, Inc. is the only responsible source capable of meeting the Government’s need with two (2) Immunochemistry Analyzers and tests for a contract performance start date of 1 April 2024.

Ortho-Clinical Diagnostics, Inc.’s analyzers have been validated, correlated, and can interface with MHS-Genesis; it is ready for patients and providers to view test results and meet the mission of providing quality healthcare. Introducing a new analyzer(s) will require a work ticket to be submitted so that it may be interfaced with MHS Genesis.

Without the interface, the laboratory would have to manually enter test results. This poses a patient safety risk due to: 1) the inherit human error risks when manually entering data; this section performs approximately 5 thousand tests at week with each test having up to 12 data entry results fields. 2) currently the laboratory does not have the manpower to sustain the turnaround time seen with an interfaced instrument.

If analyzers other than Ortho-Clinical Diagnostics, Inc.’s analyzer is connected to the network RAHC will have to submit an interface work ticket and wait potentially six (6) months to twelve (12) months or more for the instrument to be able to transmit test results directly into Cerner-MHS Genesis.

Purchasing the analyzers and tests from a vendor other than Ortho-Clinical Diagnostics, SEP 2021

Inc. would result in the Government duplicating costs that is not expected to be recovered through competition due to the extended time frame currently being experienced by DHA to validate equipment via the Cerner MHS-Genesis system.

Pursuing an award for a water-based system would require additional plumbing work necessary for the installation of a water-based analyzer. This would require changes to the current laboratory footprint and possible disruption of services until the work is completed. This in turn would require additional costs for overtime work from the facilities team to perform the necessary facility changes during non-working hours of the clinical laboratory.

The system must have an approved Authorized to Operate (ATO) to access the government network for all hardware, software, and middleware. The equipment must have a current Defense Health Agency (DHA) MHS-GENSIS laboratory instrument interface and have the availability for a 1 April 2024 start date.

In addition to the aforementioned items the following minimum salients must be met:

1. The chemistry analyzers must have or be able to:

a. Test for measles, mumps, rubella, and varicella zoster on one reagent pack.

b. Analyzer must be fully automated and random-access Multiplexing Analyzer.

c. No batch testing required.

d. Analyzer technology must minimal hands-on processing to reduce errors.

e. The preferred internal quality control must use QC Beads for improved quality and accuracy of results:

(1) Serum verification bead.

(2) Internal standard bead.

(3) Reagent blank bead.

f. Primary tube sampling.

g. Clot detection.

h. Multiplexed QC and Calibration.

i. No reagent preparation.

j. Icon driven touch screen software.

k. Consumable loading on the spot

l. Minimal time needed to perform daily maintenance.

m. Must provide a Bidirectional LIS interface.

n. A chemistry analyzer that does not require the water filter system, the system must be waterless based.

o. Must not require any added expense for plumbing, drainage, or water systems. Self-contained, on-board water management eliminates special requirements for off-board plumbing.

SEP 2021

6. Efforts to Obtain Competition: A sources sought notice for Integrated Immunochemistry and Immunoassay Analyzer and Reagents were posted with the minimum reagent requirements to https://SAM.gov from 25 January 2024 through 31 January 2024. There were four responses to the sources sought.

Ortho-Clinical Diagnostics, Inc.: Ortho-Clinical Diagnostics, Inc. submitted a response to the sources sought. Ortho-Clinical Diagnostics, Inc. can provide all elements of the requested requirement with a 1 April 2024 contract performance start date. The Ortho Clinical Diagnostics, Vitros 5600 analyzer offers the government required waterless based system. Ortho provides a product that is ATO government approval and is compatible with the MHS-GENISIS laboratory instrument interface which allows for the 1 April 2024 start date.

Abbott Laboratories, Inc.: Abbott Laboratories, Inc. submitted a response to the sources sought. Abbott stated they are an interested party in submitting our capabilities to meet your clinical chemistry needs. However, proposed analyzers did not meet Government Specifications.

Roche Diagnostics Corporation: Roche submitted a response to the sources sought.

Roche stated that they were responding and requested multiple changes to the government requirements stated in the sources sought. However, proposed analyzers did not meet Government Specifications.

Siemens Healthcare Diagnostics, Inc.: Siemens submitted a response to the sources sought. However, proposed analyzers did not meet Government Specifications.

An SBA Dynamic small business search and Quick Market search was conducted using key words “325413” and Immunochemistry and Immunoassay Analyzer with no small businesses that are currently listed.

Previous actions were evaluated and found that one vendor is consistently capable of providing the Immunochemistry and Immunoassay Analyzer, requested comprehensive list of reagents for testing with a waterless analyzer system, is ATO approved and is available to go on 1 April 2024 in order that there is not a break in service.

Internet Research found two companies, Roche Diagnostics and Siemens USA that offer Immunoassay & Immunochemistry Analyzers. However, neither of the other two vendors can perform fully and completely with a start date of 1 April 2024. Both vendors would have to make extensive changes to the water systems to come up to capability for full performance. For either of these vendors to perform there would be facilities and construction building changes to be made if the other two vendors would be considered for award. These changes could take anywhere from 6 to 18 months.

SEP 2021

a. Effective Competition. Based on market research that was conducted and the results of the Sources Sought Notice, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants. It is anticipated that only one vendor can meet this requirement due to the ability to provide day one contract performance of 1 April 2024.

b. Subcontracting competition. As per FAR 19.705-2, if a subcontracting possibility exists, the contractor will be required to submit a subcontracting plan.

Therefore, at this time only Ortho-Clinical Diagnostics, Inc. can provide the analyzer and required tests for a 1 April 2024 start date.

7. Actions to Increase Competition:

Based on market research, acquisition history, and the results of the Sources Sought Notice, competition is not anticipated for this requirement because there is currently only one vendor that can meet the 1 April 2024 start date, the requirement for a waterless analyzer system and the ATO requirement.

Previous actions were evaluated and found that one vendor is consistently capable of providing the Immunochemistry and Immunoassay Analyzer and requested comprehensive list of reagents for testing.

The Medical Readiness Contracting Office-West will continue to evaluate the capabilities of other vendor’s products and re-procure the products that provides the best value to the Government.

8. Market Research: Per an email dated 21 August 2022, Dr. Saad Khan, Chief, Medical Devices Integration, Defense Health Agency; “Defense Health Agency (DHA) has also put a hold on any new equipment that was not previously connected to MHS Genesis will be on hold for the moment. Which has resulted with Cerner having many months of backlog on PathNet builds.” Meaning no new analyzers will be interfaced with Cerner-MHS Genesis until the hold is lifted. This backlog can be from six months to one year to get the appropriate connection to Cerner-MHS Genesis.

DHA, per an email dated 5 February 2024 has recently updated their timelines for the PathNet/Instrument Integration. The timeline has improved from having a hold on any new equipment to 6 to 8 months to get any instrument dry validated/interfaced and running with MHS-Genesis. This time does not account for the wet validations running samples and getting results cross over correctly with no errors. Per the department this typically takes another 1 to 2 months. DHA also noted that to even request a request a ticket to start the process any new analyzer must have a submitted and reviewed Data Collection Workbook (DCW) for the new instrument platform. Oracle Health will not start an integration project without this task completed. Data collection workbooks are intended to capture all the data that need to be incorporated into the EHR system.

If analyzers other than Ortho-Clinical Diagnostics, Inc.’s analyzer is connected to the network RAHC will have to submit an interface work ticket and wait potentially six (6) months to twelve (12) months for the instrument to be able to transmit test results directly into Cerner-MHS Genesis.

Reynolds Army Community Hospital requirements include continued efforts for conserving water and protecting the environment from additional waste that is returned via the wastewater. Ortho Clinical Diagnostics provides a waterless system where the reagents require no water, plumbing or drains. The VITROS® systems are currently the only systems that does not require a water system, nor the associated drains and maintenance associated with such, allowing RAHC to continue their efforts for conserving water and protecting the environment. Secondarily the VITROS® system offers the capability of continued use in the case of a natural disaster due to no water or drainage being required. The Ortho Diagnostics Vitros® equipment and the Troponin reagent test have also been patented.

Previous actions were evaluated and found that one vendor is consistently capable of providing the Immunochemistry and Immunoassay Analyzer and requested comprehensive list of reagents for testing, the requirement for a waterless analyzer system and the ATO requirement.

An SBA Dynamic small business search and Quick Market search was conducted using key words “325413” and Immunochemistry and Immunoassay Analyzer with no small businesses that are currently listed.

DLA ECAT and Medical Master Catalog were researched and the requested Immunoassay & Immunochemistry Analyzers and requested comprehensive list of reagent supplies are currently not available on the DLA and ECAT platforms.

Federal Supply Schedules, Government wide acquisition contracts, multi-agency contracts, and any other procurement instruments intended for use by multiple agencies, including blanket purchase agreements (BPAs) under Federal Supply Schedule contracts (e.g., Federal Strategic Sourcing Initiative (FSSI) agreements accessible at http://www.gsa.gov/fssi were researched. Ortho Diagnostics has a current federal supply schedule however the requested items are currently unavailable. Abbott Laboratories, Roche Diagnostics and Siemens also have current FSS schedules however they do not have the requested items and their analyzers do not offer a waterless system.

Internet Research found three companies, Abbott Laboratories, Roche Diagnostics and Siemens USA that offer Immunoassay & Immunochemistry Analyzers. However, the three vendors cannot perform fully and completely 1 April 2024 with the requirement for

SEP 2021

a waterless analyzer system. All vendors would have to make extensive changes to the water systems to come up to speed. Wide-ranging facilities building changes would have to be made if the other two vendors would be considered for award, which would necessitate a break in service for the required tests.

9. Interested Sources:

Ortho-Clinical Diagnostics, Inc

Abbott Laboratories, Inc

Roche Diagnostics Corporation

Siemens Healthcare Diagnostics, Inc

All notices required by FAR 5.201 shall be or have been published. Any proposals received shall be considered.

10. Other Facts: The following facts support the use of other than full and open competition:

a. Procurement history.

Contract number: W81K0022P0266 Ortho-Clinical Diagnostics, Inc.

Description of requirement: Immunoassay & Immunochemistry Analyzers and Testing Method of procurement: Sole Source Contract type: Firm Fixed Price Total awarded amount: $868,522.15 Number of option periods: 1 October 2022-31 March 2024, Base + 6-month Option Number of Offerors: One Source Selection Method: Sole Source Price and ability to fulfill the Government’s requirement.

Authority cited: FAR 13.501(a)(1)(ii): sole source (including brand name)under the authority of the simplified procedures for certain commercial items.

Basis for fair and reasonable pricing: Sole Source Only one offer was received that complies with the terms of the solicitation.

Contract number: W81K0018D0008 Ortho-Clinical Diagnostics, Inc.

Description of requirement: Immunoassay & Immunochemistry Analyzers and Testing Method of procurement: Task Orders Contract type: Firm Fixed Price Delivery requirements: Annual Task Order was executed for required quantities.

Total awarded amount: $2,509,786.44

SEP 2021

Number of option periods: 31 January 2018-30 September 2022, Base + 4 Options Number of Offerors: Three Source Selection Method: Lowest Price Technically Acceptable. Price and ability to fulfill the Government’s requirement.

Basis for fair and reasonable pricing: Only one timely offer was received that complies with the terms of the solicitation.

Contract number: W81K0017P0303 1 April 2017 through 30 September 2017.

Ortho-Clinical Diagnostics, Inc.

Description of requirement: Immunoassay & Immunochemistry Analyzers and Testing Method of procurement: Full and Open Competition Contract type: Firm Fixed Price Delivery requirements: Annual Purchase Order was executed for required quantities.

Total awarded amount: $145,713.02 Number of option periods: none Number of Offerors: one Source Selection Method: Lowest Price Technically Acceptable. Price and ability to fulfill the Government’s requirement.

Basis for fair and reasonable pricing: Only one offer was received that complies with the terms of the solicitation.

Contract number: BRIDGE W81K0017P0741 1 October 2017 through 31 March 2018.

Ortho-Clinical Diagnostics, Inc.

Description of requirement: Immunoassay & Immunochemistry Analyzers and Testing Method of procurement: Sole Source Contract type: Firm Fixed Price Delivery requirements: Annual Purchase Order was executed for required quantities.

Total awarded amount: $144,108.90 Number of option periods: none Number of Offerors: one Source Selection Method: Lowest Price Technically Acceptable. Price and ability to fulfill the Government’s requirement.

Authority Cited: FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization Basis for fair and reasonable pricing: Bridge Basis for fair and reasonable pricing:

Bridge

b. Other facts. Ortho Diagnostics has the approved Authorized to Operate (ATO) to access the government network for all hardware, software, and middleware. The equipment also has a current Defense Health Agency (DHA) MHS-GENSIS laboratory instrument interface and has the availability for a 1 April 2024 start date.

11. Technical/Requirements Certification:

Approval

Based on the foregoing justification, I hereby approve the procurement of Integrated ImmunoChemistry and Immunoassay Analyzer and Reagents for Reynolds Army Health Clinic, Fort Sill, OK for $2,282,162.20 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.

Signature: Date: ________________________

Typed Name: Title: Command Advocate for Competition