J&A_Redacted.pdf

Version – February 2017

Control No. 17-0047

SOLE SOURCE JUSTIFICATION

(Simplified Acquisition Procedures under FAR Part 13.5 Not Exceeding $7M)

1. Contracting Activity: 411th Contract Support Brigade, Unit#15289, APO AP 96205-5289

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number: F2L4MG6364A001

Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _______ against FSS Contract #_____ _________ Order #___________ against Multiple Award IDIQ Contract Name or #______________

Order #_______ against a single award IDC Contract

Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) Other Funds: ________

FY: ___17____

Name of Proposed Contractor(s) and Address:

Ortho Clinical Diagnostics Korea, Johnson & Johnson Medical City, State, Zip: Yongsan-gu, Seoul, Korea 04323 Phone: (822) 6222-3500

Brand Name Buy: Yes No

3. Description of Services or Supplies: The purchased a laboratory analyzer in early 2016 that requires reagents to test multiple results from blood samples.

Without reagents, the analyzer has not been used and has sat in a warehouse. The only reagents that can be used for the Vitros 350 equipment are the reagents sold directly from company, Ortho Clinical Diagnostics. The analyzer is a sophisticated piece of machinery that performs diagnostics testing on human samples. As with other laboratory analyzers, the company’s equipment can only be used with reagents it manufactures. Ortho reagents are the only FDA approved reagents validated with the Vitros 350. Any modification is subject to FDA approval. The use of other non-FDA approved reagents will produce invalid results which are not acceptable for clinical diagnosis. The Laboratory’s accrediting agency requires that reagents be FDA approved for laboratories that are governed by US regulations, such as the is requesting two shipments per year with multiple items in each shipment as well as maintenance coverage for the equipment. Ortho Clinical Diagnostics Korea, Johnson & Johnson Medical is the only service provider for the Vitros 350 Reagent and Maintenance.

Shipment 1 (1st Month of contract award)

PRODUCT CATALO

G

NUMBE

QTY Unit Pric e

Unit Total (W)

Glucose 1707801

Blood Urea Nitrogen (BUN) 8102204 Creatinine 6802584 Sodium 8379034 Potassium 8157596 Chloride 8445207 Carbon Dioxide (ECO2) 8262396 Calcium 1450261 Albumin 8196057 Total Bilirubin 8159931 Total Protein 8392292 Alanine Aminotransferase (ALT) 1655281 Aspertate Aminotransferase (AST) 8433815 Alkaline Phosphatase Isoenzymes (ALP) 1053180 Gamma Glutamyl Transferase (GGT) 8257289 Cholesterol 1669829 Triglyceride 1336544 High-Density Lipoprotein (HDL) 6801895 Bilirubin Unconjugated Bilirubin Conjugated 8383051 Phosphorus 1513209 Performance Verifiers 1 8067324 Performance Verifiers 2 8231474 Electrolyte Reference Fluids 1765304 Calibrator Kits 1 1882208 Calibrator Kits 2 1662659 Calibrator Kits 3 1290709 Calibrator Kits 4 1204668 Calibrator Kits 25 6801896 Lamp 356666 Desiccant 1250232 Humidity Packs 1247873

TOTAL

Shipment 2 (Between 6th and 7th month of contract award)

PRODUCT CATALO

G

NUMBE

QTY Unit Pric e

Unit Total (W)

Glucose 1707801 5 Blood Urea Nitrogen (BUN) 8102204 3 Creatinine 6802584 5 Sodium 8379034 4 Potassium 8157596 4 Chloride 8445207 3 Carbon Dioxide (ECO2) 8262396 2 Calcium 1450261 2 Albumin 8196057 5 Total Bilirubin 8159931 3 Total Protein 8392292 2 Alanine Aminotransferase (ALT) 1655281 2 Aspertate Aminotransferase (AST) 8433815 3 Alkaline Phosphatase Isoenzymes (ALP) 1053180 3 Gamma Glutamyl Transferase (GGT) 8257289 1 Cholesterol 1669829 3 Triglyceride 1336544 5 High-Density Lipoprotein (HDL) 6801895 5 Bilirubin Unconjugated Bilirubin Conjugated 8383051 4 Phosphorus 1513209 2 Performance Verifiers 1 8067324 5 Performance Verifiers 2 8231474 5 Electrolyte Reference Fluids 1765304 4 Calibrator Kits 1 1882208 1 Calibrator Kits 2 1662659 1 Calibrator Kits 3 1290709 1 Calibrator Kits 4 1204668 1 Calibrator Kits 25 6801896 1 Lamp 356666 2 Desiccant 1250232 4 Humidity Packs 1247873 4

TOTAL

Maintenance Service 2

Base Period: 1 Jul 17 to 30 Jun 18 Value:

Option Period 1: 1 Jul 18 to 30 Jun 19 Value:

Option Period 2: 1 Jul 19 to 30 Jun 20 Value:

Option Period 3: 1 Jul 20 to 30 Jun 21 Value:

Option Period 4: 1 Jul 21 to 30 Jun 22 Value:

Total:

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited: Ortho Clinical Diagnostics Korea, Johnson & Johnson Medical is the only sole source provider for the Vitros 350 Reagent and Maintenance Chemistry Analyzers for the Vitros 350 at the . Ortho Clinical Diagnostics Korea, Johnson & Johnson Medical maintains high efficiency in providing on-site corrective maintenance of the Vitros 350 Reagent and Maintenance Blood Chemistry Analyzers. is requesting a service contract for a one base year with a 4 option year period. A delay in this service would greatly impede mission essential requirements in meeting blood and chemical analysis needs.

6. Efforts to Obtain Competition: Ortho Clinical Diagnostics Korea, Johnson & Johnson Medical is a proprietary laboratory analysis system that is not compatible with other reagents. The high dollar analyzer was purchased and the equipment has not been used. The only reagents that can be used for the Vitros 350 equipment are the reagents sold directly from company, Ortho Clinical Diagnostics.

7. Actions to Increase Competition: There is limited competition for this Brand Name item. Ortho Clinical Diagnostics Korea, Johnson & Johnson Medical is the only service provider for the Vitros 350 Reagent and Maintenance.

8. Market Research: Based on market research and clarification on Cornet proprietary information, this contract is only eligible for sole source. Ortho Clinical Diagnostics Co., Ltd. would be the sole source purchase for the entire contract life. The Vitros 350 equipment can only use its own company’s reagents and there are no other options available for purchase. Ortho reagents are the only FDA approved reagents validated with the Vitros 350. Any modification is subject to FDA approval. The use of other non- FDA approved reagents will produce invalid results and not acceptable for clinical diagnosis.

Since this laboratory is governed by US regulations, the use of FDA approved reagents is mandated.

9. Interested Sources:

Ortho Clinical Diagnostics Korea, Johnson & Johnson Medical City, State, Zip: Yongsan-gu, Seoul, Korea 04323 Phone: (822) 6222-3500

10. Other Facts: None

11. Technical/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.

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.

13. Contracting Officer Certification/Approval: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon Price Analysis Techniques.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.