Sole Source Justification (00HCUGDD-2020-43778).pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN

MARKET OR GSA) UNDER $250,000

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:

National Center for Environmental Health Division of Laboratory Sciences Clinical Chemistry Branch Centers for Disease Control and Prevention Atlanta, GA 30341

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch II

C. Identification of Requirement:

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

a. Sole source acquisition of: Purchase of Whole Units of Serum and Pooled Serum Collected Using CLSI C37AProtocol for the NCEH/CDC/DLS CDC Clinical Standardization Programs from Solomon Park Research Labs

b. Procurement Request (PR) Number (if available): 00HCUGDD-2020-43778

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

a. Proposed Vendor: Solomon Park Research Labs

b. Estimated Procurement Amount: $

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

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

Rev. 5/15/17

D. Justification:

1. The justification for this non-competitive action is: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

☒ 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 ☐ Brand name required

2. Other facts supporting sole source procurement:

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

Only Solomon Park Research Laboratories is certified to provide the materials meeting the CLSI C37A requirements for the collection and storage of commutable, high quality serum necessary for the highly selective sample analysis of lipids in human serum, and for use in trueness control and calibration studies which are ongoing in the CDC Clinical Standardization Programs. Serum used in the programs must be collected off-the-clot on ice to minimize enzymatic degradation or alteration of serum units in order to replicate serum collection in tubes used in patient care, without the addition of anticoagulants, additives or stabilizers as required by CLSI C37A. The preparation of these samples to these specific requirements can only be met by Solomon Park Research Laboratories for this program.

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

Howard D.

Bish -S

Digitally signed by Howard D. Bish -S Date: 2020.03.31 11:10:44 -04'00'

2 vendors were identified for consideration to provide the sample storage supplies using three general criterion for evaluation of (1) whether they represent high specifications for commercially available products (2) past performance and ease of use and (3) whether they are comparable to each other in overall performance, cost, availability and special features. These vendors (Bioreclamation LLC and Tennessee Blood Services) are contacted but they are unable to provide us with the specific samples with guaranteed requirements. Bioreclamation LLC- 123 Frost St Westbury, NY 11590, Phone: (516) 483-1196. This vendor could not offer single donor serum units at the requested specifications. This vendor does not collect and store serum according to the strict CLSI C37A requirements, and is therefore not suitable for use in the Clinical Standardization Program. Tennessee Blood Services- 807 Poplar Avenue, Memphis, TN 38105, Phone: (901)526-0293.

This vendor provides single donor human serum units collected off-the-clot, but does not adhere to all of the CLSI C37A requirements for the collection of commutable, high quality human serum. Thus, this company cannot meet our specifications or offer these products as required to continue activities within the CDC Clinical Standardization Program.

3. Program Office efforts to seek potential offerors:

2 vendors were identified for consideration to provide the sample storage supplies using three general criterion for evaluation of (1) whether they represent high specifications for commercially available products (2) past performance and ease of use and (3) whether they are comparable to each other in overall performance, cost, availability and special features. These vendors (Bioreclamation LLC and Tennessee Blood Services) are contacted but they are unable to provide us with the specific samples with guaranteed requirements.

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:

Center/Institute/Office COR/Program Official Signature:

Certification Date: October 1, 2018

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.