LSJ_Lemoore_Siemens_FINAL.doc_Redacted.pdf

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LIMITED SOURCES JUSTIFICATION

FOR FEDERAL SUPPLY SCHEDULE ORDER

1. Identification of agency and contracting activity, and specific identification of the document as a “Limited Sources Justification (LSJ).”

This justification is executed by Naval Medical Center San Diego (NMCSD), San Diego, CA, on behalf of the Navy to meet the requirements of Naval Health Clinic Lemoore (NHCL).

2. Nature and/or description of contract action being approved.

The proposed action is conducted under the authority of the Multiple Award Schedule Program (Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.) and Title 40

U.S.C. 501, Services for Executive Agencies). This is a limited source action to be awarded as a new

Federal Supply Schedule (FSS) order to the contractor identified in paragraph 3 below. The placement of a Firm, Fixed-Price order is anticipated.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

The requirement is for a contract for two (2) integrated chemistry laboratory analyzers, reagents, quality controls, calibrators, maintenance, training, and consumables for Naval Health Clinic Lemoore. The contracted unit shall be capable of providing both chemistry and immunoassay testing in a single box (2 analyzers). The contracted unit shall be capable of performing general chemistry and immunoassay testing for an annual workload of 6,000 specimens. The unit shall be capable of processing a minimum of

100 samples per hour.

The automated analyzers shall be capable of general chemistry and immunoassay testing for the management of electrolytes, liver function, kidney function, cardiac function, thyroid function, and must be able to perform hormone testing, lipid testing, urine chemistries as well as other routine chemistry testing. The floor mounted analyzers must be able to test small aspiration volumes of less than 1 mL.

The analyzers shall provide real-time results with rerun/reflex testing capabilities. The analyzers must be an integrated platform containing both chemistry and immunoassay in a single box. The units shall be capable of creating Levy-Jennings control charts, calibration curves, and other necessary reports. The analyzers shall be able to report data to three (3) decimal places. The analyzers shall be able to qualitatively indicate (via suspect flag) abnormalities. The unit shall be capable of positively identifying patient samples using bar codes. The analyzers shall be capable of pre-diluted sample access mode. The analyzers shall have onboard Quality Control (QC) for all results. The analyzers shall connect with the existing floor drain to evacuate wastewater. The unit shall include an uninterruptable power supply

(UPS). The combined dimensions for the analyzers shall not exceed 139x32x47 inches (LxWxH). The electrical requirements are 115 VAC at 60 Hz, 11 amps max, 1.3 kW consumption in operating state

The vendor must include a fully functional water system for the length of the analyzer contract to support two analyzers with existing drainage system, if applicable.

The vendor shall provide installation, validation testing, user training, and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including: normal range verification, demonstration of linearity, reportable range, replication/precision studies, recovery studies, accuracy studies, and establishment of initial control ranges using control materials. The system shall be capable of bi-directionally interface with the Composite Health Care System (CHCS) and the Military Healthcare

System (MHS) GENESIS (i.e. Cerner Millenium). The vendor shall provide two (2) operational and two

(2) service manuals, each in English. Support shall be provided for the initial period of performance from

01 October 2019 to 20 September 2020, and four (4) subsequent option years.

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The system, including claims made for the product, shall be compliant with Food and Drug

Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the

United States of America. 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. The vendor is also responsible for the initial instrument operational and performance validations (if applicable).

Defense Health Program (DHP) Operation and Maintenance (O&M) Fiscal Year 20 funds in the amount of will be used for the base year. The proposed source is Siemens, 511 Benedict Ave., Tarrytown, NY 10591.

4. The authority and supporting rational (see 8.405-6(a)(1)(i) and (b)(1)) and, if applicable, a demonstration of the proposed contractor's unique qualifications to provide the required supply or service.

The statutory authority which permits restricting consideration of schedule contractors to fewer than that required in FAR 8.405-1 or 8.405-2 is 41 U.S.C. 251, as implemented by FAR 8.405-6.

Siemens is the only vendor that can provide two (2) integrated chemistry and immunoassay laboratory analyzers that meets the minimum requirements of the Government via the FSS. Siemens is the only FSS vendor that can provide two (2) automated and integrated chemistry/immunoassay laboratory analyzers which performs all necessary tests and fit into our limited space constraints, 139x32x47 inches (LxWxH), and can be fully interfaced to MHS GENESIS, which will be live at our location on October 1, 2019. The analyzers offered are not capable of fitting into the limited space required for two integrated analyzers, 139x32x47 inches (LxWxH). requested a site visit which was conducted and the vendor determined there was no fully integrated option that would work for this location due to space limitations. Dimensions of the are 57x47x29 inches (LxWxH) and dimensions of the are 19.5x39x24 inches (LxWxH). Four analyzers would be needed (two each) and will not fit into the space and immunoassay and therefore chemistry testing would not be fully integrated. The analyzer performs all tests required and is fully integrated. However, the dimensions are 110x34.9x68 inches (LxWxH) each and requires an 18ft wide area for installation which is not available at this time in the facility. Two analyzers are required and would not fit into the space available.

The Siemens Dimension EXL200 measures 55x32x47 each, therefore two (2) of these analyzers measures

110” side by side which is well within the 139” limitation, and makes Siemens the only vendor capable of meeting the size requirement. The Siemens analyzers are also capable of interfacing with MHS GENESIS immediately upon installation, so there will be no delays or patient care jeopardized as a result of testing being ceased. No other vendor offers two (2) chemistry/immunoassay laboratory analyzers, reagents, quality control, maintenance, and consumables via the FSS that meet the minimum requirements of the

Government. Only Siemens can meet the minimum requirements of the Government.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P286_49080

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5. A determination by the ordering activity contracting officer that the order represents the best value consistent with 8.404(d).

GSA has determined the prices of supplies and the schedule contracts to be fair and reasonable for the purpose of establishing the schedule contract. Therefore, ordering activities are responsible to make a separate determination of fair and reasonable pricing for individual orders. The Naval Medical Logistics

Command Contracting Officer will determine, using the procedures in FAR 15.404-1, that prices are fair and reasonable and will document such determination with a level of detail commensurate with the complexity and circumstances of each order.

6. A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research was conducted by technical experts from December 2018 to February 2019. This research consisted of reviews of similar previous procurements and a market survey, using search engines to review open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage and the ECRI sourcebook catalog. Vendors that can provide automated chemistry/immunoassay laboratory analyzers via the FSS include Siemens, and . Siemens, , and are capable of providing integrated chemistry/immunoassay platforms.

The and analyzers offered are not capable of fitting into the limited space required for two integrated analyzers, 139x32x47 inches (LxWxH). requested a site visit which was conducted and the vendor determined there was no fully integrated option that would work for this location due to space limitations. Dimensions of the are 57x47x29 inches (LxWxH) and dimensions of the are 19.5x39x24 inches (LxWxH). Four analyzers would be needed (two each) and will not fit into the space and immunoassay and chemistry testing would not be fully integrated.

The performs all tests required and is fully integrated. However, the dimensions are 110x34.9x68 inches (LxWxH) each (two analyzers needed) and requires an 18ft wide area for installation which is not available at this time in the facility.

Additionally, only the existing Siemens analyzers are prepared to interface to MHS GENESIS as this site’s medical device interface has already been built and established. Any other vendor will result in re-configuring the interface and would result in manual entry of patient results at go-live of the system.

Thus, do not meet the minimum requirements of the

Government. Siemens is the only vendor via FSS capable of providing two (2) integrated chemistry/immunoassay analyzers that will fit into our space. Siemens is the only vendor that meets the minimum requirements of the Government.

7. Any other facts supporting the justification.

This procurement uses a GSA Schedule and will be solicited and awarded in accordance with FAR

Subpart 8.4. Contract Pricing is per year. Base year plus four (4) option years total

8. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

All future requirements will be handled on a case-by-case basis.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P83_13798

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Technical and Requirements certification

I certify that the facts and representations under my cognizance which are included in this LSJ and which form a basis for this justification are complete and accurate.

Technical and Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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