Sole Source - Vitros 4600 7.10.2024 release_Redacted.pdf

Control No:

FOR OFFICIAL USE ONLY

FAR Part 13 Justification and Approval for Sole-Source

1. Contracting Activity: The Defense Health Agency (DHA), Central Markets Contracting Division, Colorado Springs.

2. Description of Action: Sole-source contract with Ortho Clinical Diagnostics. (Vitros 4600& Associated Reagents) under simplified acquisition procedures. Estimated value is under the simplified acquisition threshold.

3. Description of Supplies/Services: The contractor shall provide 319 Medical Group laboratory with one chemistry analyzer that does not require a deionized water purification system, and therefore the instrument is considered a Dry-Technology, which is the intrinsic factor. The Vitros 4600 Analyzer leverages four unique systems (Microslide technology, Mircotip technology, Microsensor technology, and Intellicheck technology to produce both chemical and immunological results utilized by Physicians to determine disease states within a patient population. The Vitros 4600 is an automated analyzer measuring 92.2 inches by 33.4 inches by 52.5 inches and weighs 1,400 pounds. The Vitros 4600 is able to perform 845 tests per hour and provides an extended reagent calibration time of 35 days. The Chemistry analyzer is capable of performing testing for the following analytes: Albumin, Alcohol, Alkaline Phosphatase, Alanine Transferase, Amylase, Aspartate Aminotransferase, BUBC, Blood Urea Nitrate, Calcium, Cholesterol, Creatinine Kinase, Chloride, Creatinine, Direct HDL, Co2, Glucose, Hemoglobin A1C, Lipase, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Protein, and Triglycerides. The contractor shall furnish all labor, tools, and preventive parts, materials, equipment, qualified personnel, administrative support, reagents, controls, calibrators, and transportation necessary to perform the services for the chemistry analyzer, as part of the lease agreement. It shall include all systems, subsystems components, and assemblies which were part of the original system purchased. All subsequent maintenance provisions shall apply to hardware, firmware, and software as appropriate, unless otherwise stated for the period of 15 Aug 2024 – 14 Aug 2025 with 4 optional years. The analyzer shall be located in the 319th Medical Group Laboratory, Bldg. 109, Rm 103, Grand Forks AFB, ND.

4. Authority Cited: Acquisition of commercial items conducted pursuant to FAR Subpart 13.106- 1(b)(1)(i) in accordance with 41 U.S.C. 1901 Simplified Acquisition Procedures.

5. Reason for Authority Cited: Ortho Clinical Diagnostics products do not require a deionized water purification system, and therefore the instrument is considered a Dry-Technology, which is the intrinsic factor. Most of the analyzers listed below are either too high throughput for the 319 Medical Group laboratory or require extensive calibration/technician monitoring that the laboratory does not have.

Extensive calibration requires calibration of analytes to occur weekly or bi-weekly, utilizing more technician monitoring to ensure acceptable values. Vitros 4600 allows for an extended calibration timeframe, better suiting a laboratory with less workers. As such, Vitros 4600 is the only analyzer with dry technology that is compatible with the Grand Forks AFB laboratory and provides an extended calibration time of 35 days for most reagents. This system does not require active water and 319 Medical Group laboratory has no active water functionality or deionized water purification system. Ortho Clinical Diagnostics' VITROS 4600 has been identified as the dry-technology supplier of reagents and consumable items for the 319 MDG. In addition, Ortho Clinical Diagnostics also offers peer group reports that enables surveillance of protected patient analyte results among other laboratories. Updating the current analyzer system with VITROS 4600 technology ensures no delay in patient care and a savings of $20K from reagents currently leftover from the laboratory's current VITROS 350 Analyzer. VITROS 4600 chemistry analyzer also has an extended calibration time that requires less maintenance that improves both productivity and efficiency saving 50 man-hours and $2K per year in maintenance cost. Additionally, the VITROS 4600 Analyzer has adjustable thresholds for chemical inventories, calibration expirations and diluent volumes which reduce the amount of analyzer start up time by 30 man-hours per years, saving $1.2K annually.

6. Efforts to Obtain Competition:

The 319th MDG customer performed a thorough review of the attached list of Chemistry Analyzers compatible with MHS Genesis. This was found at https://info.health.mil/sites/MEDLOG/healthtech/Pages/Home.aspx. The Central Markets Contracting Division asked the lab to screen the 5 Chemistry Analyzers found on the list and provide feedback on if the other Analyzers could or could not be used. Below is the review of the Chemistry Analyzers applicable for the work required in the laboratory. Most of the analyzers listed below are either too high throughput for the Grand Forks AFB laboratory, they require extensive calibration/technician monitoring that the laboratory could not support, are not available in the United States, require active water, or no longer available in the United States (U.S.). Vitros 4600 is the only analyzer with dry-technology that is compatible with the Grand Forks AFB laboratory.

Ortho-Clinical Vitros 4600 Analyzer Requesting to Sole Source

Siemens Healthcare Dimension EXL

Requires active water 5L/1hr of work or

1.32 gal/hr (pressurized water source, GFAFB facility does not have required appliances, extensive calibration, and extensive system monitoring.

Siemens Healthcare Dimension Vista 500 Analyzer no longer available in the U.S.

Ortho-Clinical Vitros 5600 High Throughput Analyzer, Outside scope for Grand Forks

Siemens Healthcare Vista 500 Analyzer no longer available in the U.S.

7. Actions to Increase Competition: Posting Notice of Intent to Sole Source on SAM.gov.

8. Market Research: DHA Contracting reviewed the requirements package for the Chemistry Analyzer.

DHA Contracting independently searched the MQS and MSS listings, and the DLA ECAT and DLA Medical Master catalogs. There were many Chemistry Analyzers available.

However, to meet the requirements identified in the Performance Work Statement, the Chemistry Analyzer is required to be a MHS GENESIS Approved Device or have the ability to be a MHS Genesis Approved Device; and the contractor must read, agree to and adhere to the timelines listed in the DHA Cybersecurity RMF Requirements listing to include documentation (completed within 4 months of contract award) and technical requirements (completed within 6 months of contract award).

Additionally, research was conducted amongst a variety of instruments in the same price range. A comparison could not be made amongst similar instruments because no other instrument exists with the same technology as the Vitros 4600 --it is a one-of-a-kind instrument due to its dry-technology.

Signature:

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

Typed Name: Tina D. Mitchell Date: 7/11/2024 Title: Contracting Officer

Signature:

Encl:

GF MHS GENESIS Approved Device Listing Sept 2022

MITCHELL.TINA.D

IANE.1185302241

Digitally signed by

MITCHELL.TINA.DIANE.1185302

Date: 2024.07.11 16:17:51 -05'00'

MITCHELL.T

INA.DIANE.1

185302241

Digitally signed by

MITCHELL.TINA.DI

ANE.1185302241

Date: 2024.07.11 16:24:11 -05'00'