JA_Redacted.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD on behalf of Naval

Health Clinic Cherry Point, North Carolina to meet their requirements.

2. Nature and/or description of the action.

The proposed action is one (1) analyzer, laboratory, urine, automated (Device Code 16-378) for Naval Health Clinic

Cherry Point. The Government intends on awarding a Firm Fixed Price (FFP) contract. The proposed source is

Beckman Coulter Inc, 250 S. Kraemer Blvd, Brea, CA 92882, or an authorized Beckman Coulter distributor.

3. Description of the supplies/services required.

The requirement is for one (1) automated urine laboratory analyzer for Naval Health Clinic Cherry Point. The system shall be capable of performing at least the tests listed below for an estimated annual workload of at least

6,000 microscopic samples and 7,200 chemistries.

TEST

Color

Clarity pH

Protein

Glucose

Ketone

Bilirubin

Blood

Nitrite

Urobilinogen

Leukocytes

Specific gravity

Formed Elements – Red Blood Cells

Formed Elements – Squamous Epithelial Cells

Formed Elements – Yeast

Formed Elements - Crystals

Formed Elements - Sperm

Formed Elements – White Blood Cells

Formed Elements - Bacteria

Formed Elements – Casts

Formed Elements – Non-squamous Epithelial Cells

Formed Elements – Ova and parasites

Body fluids

The system shall be fully automated and capable of performing both macroscopic and microscopic testing. The system shall be capable of performing high detection of urine sediments. The system shall be capable of auto correcting for abnormal urine colors. The system shall be capable of interfacing with the Composite Health Care

System (CHCS), Military Healthcare System (MHS) Genesis, and the laboratory information system. The system shall provide reagent barcode reading capability and inventory control including archiving and active reagent volume monitoring and warning. The system shall be capable of reading bar coded patient samples using the VistA

Universal Identification system, and have the ability to run patient samples manually, with or without barcodes, during HIS/LIS downtime.

The system shall include a computer workstation with the ability to locate patient samples using patient name, SSN, or unique ID, and determine when results will be available. The workstation shall be capable of generating and printing patient reports in a chartable medical record format that may be sent to providers during HIS/LIS downtime.

The workstation shall be capable of retransmitting results after LIS or instrument downtime. The workstation shall be capable of easily adding or updating quality control and calibrator materials and values and track changes. The workstation shall be capable of running new and old lot numbers of QC concurrently for parallel testing. The workstation shall be capable of using only one printer to print QC data, review screens, or print files while running patient samples.

The system shall include an interactive on-board QC package with modified Westgaard rules and Levy-Jennings plots. QC results shall be printable and include standard deviation index. The QC package shall include electronic archiving and corrective action documentation. The system shall allow evaluation and printing of QC results while the instrument is analyzing patient samples. The system shall allow monitoring of calibrations for slope, intercept, and blank. The system shall allow export of values to a commercial quality control program.

The system shall include bidirectional LIS host query with a Data Innovations interface. All equipment, software, and drivers needed to interface the system to the LIS shall be included. The system shall allow for reviewing abnormal results on the instrument. The system shall be capable of providing true STAT interrupt. The system shall be capable of a throughput of at least forty (40) tests per hour. The system shall have a detector system for bubbles, clots, and incomplete sample aspirations. The system shall have a cleansing mechanism for small clots. The system shall not require external water, pressure, or vacuum. The system shall be calibrated on assayed material compatible with CAP guidelines. The analyzer shall compile all calculation. Calculation factors shall be stored internally and activated internally at the operator’s discretion. The system shall be capable of providing microscopic images on the instrument screen. The electrical requirements are 110VAC, 60 Hz. System installation, validation, correlation, onsite training, and startup consumable kits shall be included.

The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United

States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1), FAR 13.106-1(b)(1), brand name only. There are multiple distributors capable of providing the equipment that meets the minimum government requirements.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Beckman Coulter Inc. is the only manufacturer that can provide an automated urine analyzer capable of performing both chemical and microscopic urinalysis wherein microscopic images are provided on the instrument. Direct visual microscopic evaluation of samples in conjunction with chemical testing is required by Naval Health Clinic Cherry

Point. Integration of these two test parameters on a single instrument improves laboratory workflow, reduces potential for error, and reduces the consumable supplies required to be kept in inventory by the lab. Beckman

Coulter Inc. is the only manufacturer which offers a system which meets the minimum requirements. No other manufacturer can provide an automated urine analyzer capable of performing both chemical and microscopic urinalysis wherein microscopic images are provided on the instrument.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the

FedBizOpps in accordance with FAR 5.202.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in October 2017. It included a search of the Internet using Google, Bing, GSA

Advantage, and the ECRI Sourcebook. Manufacturers who can provide automated urine analyzers include Beckman

Coulter, Siemens Healthcare Diagnostics, Sysmex America Inc, and Roche Diagnostics. The analyzers available from Sysmex and Roche are not capable of both chemical and microscopic urinalysis and thus do not meet the minimum requirements. Siemens offers the CLINITEK AUWi, which is a combination of a Siemens CLINITEK

Novus chemical urine analyzer and a Sysmex UF-1000i microscopic urine analyzer. However, the CLINITEK

AUWi is not capable of providing microscopic images on the instrument and thus does not meet the minimum requirements. Beckman Coulter offers the iRICELL 1500, which is the only automated urine analyzer available capable of performing both chemical and microscopic urinalysis wherein microscopic images are provided on the instrument. The iRICELL 1500 is available from Beckman Coulter and its authorized distributors.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact

The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval is Yun Hong, who may be reached at (301) 619-8895.