JA for Chemical _Signed.pdf

Control Number: 20-RHCO-A-126

RFQ W91YTZ-20-Q-0066

Siemens Dimension EXL with LM Chemistry Analyzer

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: U.S. Army Medical Command, Regional Health Contracting Office - Atlantic, 6011 5th Street, Bldg. 1469, Fort Belvoir, VA 22060

2. Description of Action: Approval is requested for a follow-on contract for chemistry testing services on the Siemens Dimension® EXL with LM analyzer, to include the Millipore AFS Essential 8D water filtration system and UPS at McDonald Army Health Center Laboratory. The previous award W91YTZ-19-P-0401 was awarded to Siemens Healthcare Diagnostics as they are the proprietary vendor for the maintenance of their system. This follow-on contract will be cost per reagent reportable (CPRR) with a base and four 12 month option periods. The funding type is Operational and Maintenance (O&M).

3. Description of Supplies/Services: All reagents, calibrators, and consumables necessary to the operation of the Siemens Dimension® EXL with LM analyzer, including water filtration system, and telephonic troubleshooting and on-site service with all parts and labor to perform scheduled preventive maintenance in accordance with current Preventive Maintenance Check List. The service includes unscheduled repair visits regarding the item listed in the Service Agreement. The analyzer is proprietary to Siemens Healthcare Diagnostics, and only the Manufacturer of the equipment can provide the Calibration, Repair and Preventive Maintenance Checks on stated Siemens Dimension® equipment according to FSS V797D-30175. Siemens is the only manufacturer of the repair parts specific to the units listed. This follow-on contract will be a cost per reagent reportable (detailed below) with a base and 4 option years.

Billable Name

Projected Annual Usage

Cost per Reagent Reportable (dollars)

CPR DIM Potassium 16146 0.16650 CPR DIM Sodium 15988 0.16765 CPR DIM Glucose 16184 0.24219 CPR DIM Calcium 14595 0.23107

CPR DIM GPT/ALT 13141 0.23015

CPR DIM Urea Nitrogen 14559 0.23131

CPR DIM GOT/AST 13140 0.22820

CPR DIM GGT 278 1.07039

CPR DIM Bilirubin Total 13199 0.23361 CPR DIM Alkaline Phosphatase

13132 0.11642

CPR DIM CK 241 8.32048

CPR DIM Lipase 265 3.00261 CPR DIM Uric Acid 549 1.20514

For Official Use Only (See FAR 2.101 and 3.104-4)

(12 September 2019)

(25 February 2016)

RFQ W91YTZ20Q0066

Chemistry Testing Services for the Siemens Dimension® EXL with LM Analyzer in support of McDonald Army Health Center, Fort Eustis, VA, 23604

CPR DIM Total Protein 13123 0.23420 CPR DIM Chloride 15976 0.16765 CPR DIM Amylase 183 5.52440 CPR DIM Cholesterol 11191 0.23208 CPR DIM Triglyceride 11202 0.65094 CPR DIM HDL Cholesterol 11194 0.65123 CPR DIM Opiates 1765 1.57531 CPR DIM Benzodiazepines 1765 1.57531 CPR DIM Cannabinoids 1765 1.57531 CPR DIM Cocaine Metabolites

1765 1.57531

CPR DIM Albumin 13906 0.22911 CPR DIM LDL Cholesterol 1103 4.82987 CPR DIM Ethanol 244 6.04973 CPR DIM Amphetamines 1765 1.57531 CPR DIM CKMB Mass 31 370.44000 CPR DIM Valproic Acid 27 97.05481 CPR DIM Methadone 1765 1.57531 CPR DIM Barbiturates 1765 1.57531 CPR DIM Iron 883 1.15092 CPR DIM Phosphorus inorganic

828 0.31754

CPR DIM Bilirubin Direct 270 0.39026 CPR DIM Magnesium 550 2.10469 CPR DIM Lactate 59 9.65763 CPR DIM Carbamazepine 11 238.22545 CPR DIM Protein 109 4.41888 CPR DIM Beta HCG 353 8.99600 CPR DIM Ecstasy 1765 1.97431 CPR DIM Phencyclidine 1765 1.57531

CPR DIM IBCT 825 2.36115

CPR DIM CO2 enzymatic 15797 0.22637 CPR DIM Creatinine enzymatic

14933 0.35446

4. Authority Cited: 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. Siemens Healthcare Diagnostics is the original equipment manufacturer and the proprietary vendor for maintenance of the equipment.

5. Reason for Authority Cited: Siemens Healthcare Diagnostics is the original equipment manufacturer and the proprietary vendor for maintenance of the equipment.

Only the Manufacturer of the equipment can provide the Calibration, Repair and Preventive Maintenance Checks on Dimension® Equipment. Siemens is the only manufacturer of the repair parts specific to the units listed. Original Equipment Manufacturer (OEM) specification are the only source of specifications need to properly maintain these items. Manufacturer has sole right to their proprietary designs, equipment diagnostics software. Failures to utilize proprietary operating system software may result in the inability to identify equipment operation parameters, failures of device and the inability to accurately calibrate the equipment. MCAHC requires the OEM to maintain this high end, lifesaving equipment. Diagnostic testing analyzers are subject to the College of American Pathologists accreditation, if providing services under Medicare or Medicaid reimbursement. Meeting OEM operating specifications is a minimum requirement in order to be certified by College of American Pathologists and other regulatingagencies.

6. Efforts to Obtain Competition: The MCAHC Laboratory personnel have not made an effort to obtain competition because Siemens Healthcare Diagnostics is the original equipment manufacturer and the proprietary vendor for maintenance of the equipment.

Based on the results of market research and the posting of the Pre-solicitation Notice on 6 February 2020, the Contracting Officer has determined that there is no effective competition anticipated for this acquisition. There have been no inquiries or responses to the Pre-solicitation Notice to date. This J&A will be posted on Beta.SAM.gov with this solicitation which will inform companies of the requirement and potentially, long term effect the vendor base for this requirement.

a. Effective competition. Siemens Healthcare Diagnostics is the only company that can perform the required maintenance on the Dimension® EXL with LM Analyzer. Based on the results of the market research and the proprietary nature of the equipment there is no effective competition anticipated for this acquisition.

b. Subcontracting competition. There are no subcontracting possibilities for this requirement. A subcontracting plan is not required.

7. Actions to Increase Competition: It is not possible to increase competition at this time because the sole manufacturer of the equipment to be maintained is Siemens and they have proprietary knowledge of the equipment making them the only company capable of performing the required services. A copy of the solicitation will be posted on the Beta.SAM.gov website. Any proposals received will be considered for future requirements.

8. Market Research: Market Research was conducted in accordance with FAR Part 10 by the Contracting Officers Representative and the Contract Specialist. A search of the Dynamic Small Business website was conducted for NAICS Code 811219 “Other Electronic and Precision Equipment Repair and Maintenance,” revealed large numbers of vendors. However, the large number of small businesses listed below is misleading because the NAICS used 811219 “Other Electronic and Precision Equipment Repair and Maintenance,” is a broad category which means that many of the small businesses listed below may be able to maintain certain Chemistry diagnostic testing analyzers, but not the Dimension® EXL with LM because it is proprietary.

(1) The SBA Quick Market Search was completed on 29 January 2020 using the

NAICS 325413, Virginia. The search for each socio-economic group are asfollows:

Table 1 –DSBS Quick Search Results

8a and 8a Joint Venture 5

Any Women Owned Business 4

HUBZone Certification 1

Service Disabled Veteran Owned 8

Veteran Owned including Service Disabled Veteran 9

(2) A search of the GSA Library under source FSC Class 6630, SIN 66-102, “Chemistry, Biochemistry, Clinical Instruments, General Purpose Laboratory Instruments” revealed that Siemens Healthcare Diagnostics has a presence on GSA, the schedule contains equipment rental, maintenance and repair services Supplies are provided under the cost per reagent reportable Lease program.

9. Interested Sources: To date, no other sources have written to express an interest.

The notices required by FAR 5.201 shall be published, and any bids or proposals received shall be considered.

10. Other Facts:

a. Procurement history.

(1) The current contract W91YTZ19P0401 expires on 31 March 2020. Siemens Healthcare Diagnostics is the only vendor that can fulfill the requirement. Siemens is the sole manufacturer of the proprietary equipment to be maintained.

(2) The competitive status of the action: This action was competed as a Brand Name.

(3) Authority previously cited if less than full and open competition was used. FAR 13.106-1(b)(1)(i).

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. The customer contacted three vendors, only one of which, Siemens USA, LLC, could provide Siemens analyzers and supplies.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. None.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. Siemens has proprietary rights to the equipment and supplies. There have been no significant changes.

b. Other facts. None

11. 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. I certify these products are not available using mandatory sources and delivery cannot be made by the required delivery date.

MELCHERT.VALERIE.ELLEN.1385672 Digitally signed by

Signature: 760

MELCHERT.VALERIE.ELLEN.1385672760

Date: 2020.02.26 15:28:36 ‐05'00' Date:

Typed Name:Valerie E. Melchert Title:_Chief, Laboratory Services

12. 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.

MELCHERT.VALERIE.ELLEN.138 Digitally signed by

Signature: 5672760

MELCHERT.VALERIE.ELLEN.1385672760

Date: 2020.02.26 15:29:21 ‐05'00' Date:

Typed Name:Valerie E. Melchert Title:_Chief, Laboratory Services

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on a market research and the Independent Government Estimate. A price analysis will be conducted comparing the offeror’s proposal with current or recent prices for the same or similar items, adjusted to reflect changes in the market conditions, economic conditions, and quantities. Commercial Items are being acquired therefore cost or pricing data is not required per FAR 15.403- 1(b) (3).

Signature: Date: 26 March 2020

Typed Name: Barry Baxter Title: Contracting Officer

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

Signature: Date: 26 March 2020

Typed Name: Barry Baxter Title: Contracting Officer