Sole-Source_Justification_Biocare-signed.pdf

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Service Agreement for the Biocare Medical IntelliPATH System
Solicitation number
NIEHS-4482883
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SOLE SOURCE JUSTIFICATION / LIMITED SOURCES JUSTIFICATION

1. Agency/Contracting Activity:

HHS/NIH/NIEHS - Office of Acquisitions (OA) 111 TW Alexander Drive Research Triangle Park, NC 27709

2. Description of Action:

Nature: New Requirement Follow-On Requirement Modification to Existing - Purchase Order/Contract Number: ________________________

Pricing: Fixed Price Time and Materials / Labor Hour Cost Reimbursement Other (specify): ______________________________

3. Procurement History:

Previous Purchase Orders(s) or Contract(s):

Was previous action awarded competitively?

Yes No If Yes, Purchase Order/Contract Number: ________________________

Yes No N/A If No, summarize justification rationale used:

4. Description of Supplies/Services:

a. Project Title:____________________________________________________________________

b. Suggested Contractor: _______________________________________________

c. The total estimated dollar value of the proposed action is $___________

d. Period of Performance:________________________________

e. Description of Requirement:

5. Authority (# 5 will be addressed by OA):

FAR 13.106-1(b)(1). For purchases acquired using FAR 13 procedures, not exceeding the simplified acquisition threshold (SAT < $150,000), Contracting Officers may solicit from one source, if the Contracting Officers determines that the circumstances of the contract action deem only one source reasonably available (e.g. urgency, exclusive licensing agreements, brand name, or industrial mobilization.

FAR 8.405-6(a)(1). For a proposed GSA order with an estimated value exceeding the micro-purchase threshold (MPT < $3500) the only circumstances that may justify the action are: (A) An urgent and compelling need exists, (B) Only one source or

(C) Logical follow-on to an original Federal Supply Schedule.

6. Reason for Authority Cited:

Source Selection Sensitive - See FAR 3.104 and 2.101 Version: 06/30/2016

If the project is a continuation or renewal of an ongoing order, provide the current order number and indicate:

(i) the name of the incumbent/predecessor Contractor;

(ii) the period of performance;

(iii) total dollar amount obligated to date;

(iv) whether the initial and any subsequent awards were competed; and for any sole source awards, the basis for the approved justification.

The summary/justification rationale field may be used to provide this information, if applicable.

Estimate provided shall include shipping/handling, travel, and any other anticipated costs.

Please provide a detailed description of what your project will entail, including general description of deliverables and/or tasks to be conducted.

Also specify any project background that is important to understanding the acquisition and the need it will satisfy.

Describe in detail why only the designated supply or service will meet the organization’s needs and the contractor’s unique qualifications to provide the requirement.

Justifications may be based on rationales such as:

- Only one responsible source available / Unique or highly specialized requirement

- Unusual and compelling urgency

- Exclusive licensing agreements

- Specific Brand Name Required

7. Actions to Increase Competition:

8. Market Research:

9. Additional information to support the justification:

10. Fair and Reasonable Price Determination: As Contracting Officer, I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Basis for the determination: price analysis techniques.

11. Program office certification.

The undersigned hereby certify that the portions of this justification that have been developed by the below listed program office personnel, including supporting information and/or data verifying the Government’s minimum needs or requirements, or other rationale for sole sources, are accurate and complete.

OFFICIAL

NAME, BRANCH / DIVISION &

TITLE SIGNATURE DATE

Project Officer (PO) or

Program Official Project Officer (PO) or

Program Official’s Immediate Supervisor

12. Contracting Officer Certification and Approval.

I hereby certify that this Justification is accurate and complete to the best of my knowledge and belief. Based on the foregoing, I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition

OFFICIAL

NAME, BRANCH / DIVISION &

TITLE SIGNATURE DATE

Contracting Officer

Source Selection Sensitive - See FAR 3.104 and 2.101 Version: 06/30/2016

Provide a brief statement as to whether or not there are future plans to acquire the same type of supplies or services, e.g., further extensions or renewals by competitive or other means.

If subsequent acquisitions are anticipated, cite actions taken, or anticipated, to avoid continued limitation of sources for the requirement in the future and a schedule for accomplishing those actions. (NOTE: This may involve recompeting a successor requirement at a logical juncture in the phasing of the project or “breaking out” segments of the requirement to facilitate competition, where feasible.)

If no actions have been or will be undertaken to overcome barriers to competition for future acquisitions, so indicate and provide an explanation.

(1)Describe the extent and the results of the market research. List all the sources identified.

(2) Provide the timeframe the market research was completed and who compiled the data. (Research must be meaningful and have been conducted within the previous 12 months)

(3) List any contractors, other than the suggested contractor, that were contacted and the results of that communication or other market research performed. If other contractors were not contacted or other market research was not conducted, provide an explanation.

If the justification is based on an urgent and compelling need, indicate (using data, estimated cost, or other rationale) the extent and nature of the harm that the sponsoring organization would incur and/or the unacceptable delays that would occur.

[NOTE: The length of an order awarded under these circumstances cannot exceed one year unless approved by the Head of the Contracting Activity (HCA).]

New Requirement: Off
Follow-On Requirement: Yes
Modification to Existing: Off
Purchase Order/Contract Number:
Fixed Price: Yes
Time and Materials / Labor Hour: Off
Cost Reimbursement: Off
Other: Off
Other Specify:
Previous Purchase Orders(s) or Contract(s) number: HHSN273201600093P
Yes1: Yes
No1: Off
Yes2: Off
summarize justification rationale used: Biocare Medical, LLC is the only source capable and available to provide the required services and maintenance for the IntelliPath System.
Project Title: Repair and Maintenance Agreement Renewal for the IntelliPATH System
Suggested Contractor: Biocare Medical, LLC.
The total estimated dollar value: $55,576.31
Period of Performance: 04/22/2017-04/23/2022
Description of Requirement: The Cellular and Molecular Pathology Branch has a requirement for the continued Repair and Service Maintenance Agreement of their Biocare Medical IntelliPath system. This contract action is for renewal of the annual repair and service agreement for this system. The current maintenance agreement is due to expire in Apirl 2017. This agreement will include services, repairs, on-site labor, parts, phone support, and software upgrades. Additionally, this agreement will include two (2) preventive maintenance inspections every six (6) months of this agreement.
FAR 13:
106-1(b)(1): Yes
a) An urgent and compelling need exists: Off
b) Only one source: Off
Logical follow-on to an original Federal Supply Schedule: Off
Reason for Authority Cited: Biocare Medical LLC., is uniquely qualified to perform repairs, upgrades, and preventive maintenance (PM) services on the very delicate and advanced IntelliPath system and its associated software. Biocare engineers designed the IntelliPath system hardware and software, and such hardware and software is proprietary in nature. Biocare Medical, LLC., is the only source with the capability and rights to provide the maintenance, repairs, and software updates required to ensure continuous operation of the system. No other source has the technical ability to work on the system, nor the required access to proprietary parts and software updates.
Actions to Increase Competition: Market research has revealed that the manufacturer does not work with any authorized resellers. Therefore, the Government only expects to receive one quote from the suggested source, Biocare. As the Government is currently engaging in continuous contact with other researchers and online research is ongoing to locate other manufacturers that are capable of meeting this requirement in

the future, the Government will post a Request for Information (RFI) in the market place for any future procurements. Personnel within the the Pathology Brach will continue to monitor the ability of firms other than Biocare to provide repair and maintenance services for the IntelliPath System. Should such sources be identified, they will be extended the opportunity to compete for subsequent acquisitions of this kind.

Market Research: Web searches were performed and trade journals reviewed to search for other vendors that are able to service the Biocare Intellipath FLX. None were located. An expert on the Intellipath FLX was contacted and determined that third party vendors could not service the instrument since parts are only available to Biocare engineers. The software that controls the instrument is proprietary to Biocare Medical. No other vendor can repair or update this software.
Additional information to support the justification: This instrument is one of the primary methods used to perform IHC stains required by NIEHS DIR and NTP investigators. It is necessary to complete a high volume of projects in a timely manner.
roject Officer (PO) or Program Official Name: Dr. Ronald Herbert, Head Pathology Support
2017-02-07T11:35:47-0500
Ronald A. Herbert -S
roject Officer (PO) or Program Official Date: 02/07/17
Project Officer (PO) or Program Official’s Immediate Supervisor Name: Dr. Robert Sills, Chief, CMPB
2017-02-07T12:02:30-0500
Sills, Robert (NIH/NIEHS) [E]
Project Officer (PO) or Program Official’s Immediate Supervisor Date: 02/07/17
Contracting Officer Name: Hugo O. Alcantara, OA, Contracting Officer
2017-02-22T11:35:36-0500
Hugo Alcantara -S
Contracting Officer Date: 2/22/2017
No2: Yes
NA2: Off

File details come from the government source that posted it. Updated .