CDC_Epredia Autostainer Service 2024-2029_Limited Source_Redacted_Signed.pdf

Rev. 1/6/14

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN

MARKET OR GSA) UNDER $150,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

CDC, NCEZID, IDPB

Roybal Building 18, MS: H18-SB Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition Branch NCEZID

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Service Agreement with Epredia for Epredia Autostainers (480S and 360)

b. Procurement Request (PR) Number (if available): 00HCVLED-2024-82779

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Epredia, Richard Allen Scientific, LLC, 4481 Campus Drive, Kalamazoo, MI 49008

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

D. Justification:

1. The justification for this non-competitive action is:

☐ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer 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). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand-name.”

☐ Urgency

☐ Exclusive licensing agreements/Proprietary data

☐ Brand name required

☐ Industrial mobilization

☐ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency

Only One Source

☐ Logical Follow Up

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

These Autostainers are highly specialized to provide immunohistochemistry results and Epredia is the only one source that is authorized to provide technical support and maintenance to their equipment at the level of quality required because the maintenance or services are unique or highly specialized. Failure to be serviced by a vendor other than the manufacturer would require us to perform validation which would put an undue financial and time burden on our lab.

b. What other products/services were considered and why did they not meet the need?

No other services are capable of maintaining this equipment at the unique or high quality level to warrant accuracy of this machine.

3. Program Office efforts to seek potential offerors:

Market Research was done through GSA and other companies but none appear to have specialized experience in servicing the Epredia Instruments. Epredia is the single source of this service agreement

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: Theresa Brabham

Center/Institute/Office COR/Program Official Signature:

Certification Date: 05/27/2022

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.