A.02.04_JA-16-RHCO-P-113r.pdf

Control Number: 16-RHCO-P-113

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

(1 October 2015)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office – Pacific (P), US Army Medical Command, Fort Shafter, Hawaii

2. Description of Action: Request approval for a new cost per test reagent rental contract. Army working capital funds will be used for the procurement. The estimated cost for a base period and (2) one year option periods is $764,137.56.

3. Description of Supplies/Services: This requirement is for the Ventana Medical System Platforms (reagents and the instruments): Benckmark Ultra, the Symphony, and the Benchmark Special Stains to be used at the Tripler Army Medical Center Department of Pathology for a base plus two option years.

4. Authority Cited: The statutory authority permitting other than full and open competition is 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 Special Program for Certain Commercial Items.

5. Reason for Authority Cited: Sole Source procurement for the Ventana Medical Systems Platforms is most advantageous for the government for the following reasons:

1) Zero hazardous waste and prepackaged reagents for this requirement are required by TAMC’s Department of Pathology to ensure the safest working environment possible.

2) The reagents and technology utilized on the Ventana Medical System Platforms for waste removal completely eliminates hazardous waste generation during processing runs, meeting the Government need/requirement to reduce the generation and subsequent costly disposal of hazardous waste. The xylene substitute, alcohol substitute and prepackaged reagents utilized for specimen staining have been cleared by the EPA, OSHA, and the State of Hawaii for straight to drain waste disposal. This is the only instrumentation for this type of testing that is currently xylene and alcohol free, and therefore cleared for straight to drain waste disposal. The prepackaged reagents significantly reduce employee exposure to open reagent sources, meeting the Government need/requirement for the safest work environment possible. Implementation of these platforms will reduce hazardous waste disposal expenditures by approximately 55% within the Anatomic Pathology Section.

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Ventana Benckmark Ultra, the Symphony, and the Benchmark Special Stains

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

(1 October 2015)

6. Efforts to Obtain Competition:

a. Effective competition. Extensive market research was conducted via internet searches for equipment that performed H&E, IHC, and special stains. This research yielded 3 companies which made instrumentation that performed these functions. All 3 of these companies provided more extensive information on their products and provided in-house demonstrations.

Competition for this acquisition is not anticipated as market research, and company demonstrations showed that this is the only company that has been cleared by the EPA, OHSA, and the State of Hawaii for straight to drain waste disposal based on the fact that the platforms do not use xylene and alcohol (hazardous waste) as part of their process. Further, a Request For Information for additional Sources Sought was issued on 4 Feb 2016 to close on 19 Feb 2016 with no inquiries.

b. Subcontracting competition. There are no known subcontracting opportunities and this system is proprietary to Ventana.

7. Actions to Increase Competition: It is the Governments best interest to reduce the generation and the subsequent disposal of hazardous waste. Market research has shown that at the present time, Ventana is the only company that offers xylene and alcohol free processing, greatly reducing the generation and need for disposal of hazardous waste. The Government would consider other systems that generated zero hazardous waste and provided pre-packaged stains/reagents.

8. Market Research:

Market research revealed that only the Ventana Medical Systems Platform offered a xylene and alcohol free system, sealed, pre-packaged stains/reagents, and fresh reagent for each slide.

9. Interested Sources: Ventana, Dako, and Leica have written to express interest in the acquisition.

Of these three, only Ventana met the Government’s minimum need. As stated above, the Government has a need for a xylene/alcohol free (zero hazardous waste production), minimum exposure to stains/reagents via pre-packaged solutions, and fresh stain/reagent for each slide. The notices required by FAR 5.201 will be published, and any bids or proposals received shall be considered.

10. Other Facts: N/A

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

(1 October 2015)

a. Procurement history. This is a new procurement, thus the following items are not applicable:

(1) Contract numbers and dates of the last several contracts for these same requirements. N/A

(2) The competitive status of these actions. N/A

(3) Authority previously cited if less than full and open competition was used. N/A

(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. N/A

(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. N/A

(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. N/A

b. Other facts. N/A

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.

Signature: ________________________________Date: __________

Typed Name: Alison K. Knight Title:__________________________

12. Requirements Certification: Include the following statement:

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.

Signature: ________________________________Date: __________

Typed Name: ____________________________Title:__________________________

Alison.Knight Typewritten Text 25 Feb 2016

Alison.Knight Typewritten Text Medical Technologist Supervisor GS12

Alison.Knight Typewritten Text Gregory Johnson

Alison.Knight Typewritten Text Acting Chief, Department of Pathology

Gregory.A.Johnson Typewritten Text

26 FEB 2016

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

(1 October 2015)

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. The basis of this determination will be using available competitively published price list, and contracts awarded for similar items. Additionally, certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Signature: ________________________________Date: __________

Typed Name: _Sandy H. Mitsuda_____________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: __________

Typed Name: _Sandy H. Mitsuda_____________Title:___Contracting Officer________

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