Sole Source Justification (00HCUGDK-2020-44299).pdf

Rev. 5/15/17

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:

Centers for Disease Control and Prevention National Center for Environmental Health Division of Laboratory Services Clinical Chemistry Branch/Lipid Reference Laboratory Chamblee Campus 4770 Buford Hwy NE, MS F25 Building 110 Atlanta, GA 30341

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition Branch II 2920 Brandywine Road, Mail Stop K-69 Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: (1) BaChem Parathyroid Hormone and Thyroid Stimulating Hormone Synthetic Protein Standards

The objective of this procurement is to obtain phosphorylated and oxidized parathyroid hormone (PTH) synthetic proteins as well as thyroid stimulating hormone (TSH) synthetic proteins (e.g., alpha and beta isoform 1 and 2) standards to support of the activities for the CDC’s Clinical Standardization Programs, PATH, and the Division of Laboratory Sciences Service Laboratory.

b. Procurement Request (PR) Number (if available):

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

a. Proposed Vendor:

BaChem Americas, Inc.

3132 Kashiwa Street Torrance, CA 90505 Contact: Shabnam Mohandessi Phone: (678) 548-0481 Email: shabnam.mohandessi@bachem.com

b. Estimated Procurement Amount: $

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

If yes, provide schedule number: N/A

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

☐ Brand name required

2. Other facts supporting sole source procurement:

mailto:shabnam.mohandessi@bachem.com

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

Our laboratory is developing a UHPLC-HRMS reference method for the accurate measurement of the intact parathyroid molecule (PTH) and its related peptides from human serum. PTH has a very short half-life on the order of minutes, resulting in its degradation into N-terminal, C-terminal, and mid-range fragments that may have clinical relevancy. In addition, PTH can be subject to oxidation and phosphorylation.

Although the sites of oxidation and phosphorylation have been proposed in literature, no commercial standards exist for characterization and profiling purposes. BaChem has the ability to generate synthetic phosphorylated and oxidized forms of PTH with a high purity (greater than 80%), which are compatible with our mass spectrometric method.

In addition, our lab is developing a UHPLC-HRMS method for the accurate measurement of thyroid stimulating hormone (TSH). Unfortunately, no higher order reference materials exist for TSH as well as no mass spectrometric methods for detection. The traditional means of measuring TSH are by immunoassay-based clinical analyzer platforms. While recombinant materials for TSH are commercially available for the TSH beta isoform, these materials are not traceable to SI units and do not include the TSH alpha isoform. BaChem has the ability to generate synthetic TSH proteins for the alpha and beta isoforms with a high purity (greater than 90%), which are compatible with our mass spectrometric method.

All of the PTH and TSH proteins synthesized will include an HPLC report for purity and an amino acid analysis report.

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

No market research could be performed on the PTH phosphorylated and oxidized standards as they are not commercially available and instead had to be synthesized.

Market research was performed among known vendors of TSH recombinant materials. The other two products manufactured by NIBSC and OriGene were reviewed:

1. OriGene Product: TSH beta (TSHB) (NM_000549) Human Recombinant Protein.

This company only provides the TSH beta form and does not indicate which isoform is present. The purity of the material is only 80% as determined by a SDS- PAGE method. In addition, the recombinant protein was prepared in Tris.HCl and glycerol, which is not compatible with our existing UHPLC-HRMS method for TSH.

Therefore, this company cannot meet the needs of this project: OriGene Technologies, 9620 Medical Center Drive, Ste 200, Rockville, MD 20850, 1-888- 267-4436, techsupport@origene.com

2. NIBSC Products: 81/565, 94/674, and 03/192. NIBSC 81/565 is a TSH international standard that was designed for immunoassays. The units for NIBSC 81/565, 94/674, and 03/192 standards are in activity units (mIU), which is not traceable to SI. The NIBSC 81/565 and 94/674 standards not only contain TSH extract, but also other proteins such as human serum albumin and lactose, which could pose as interferences in the existing UHPLC-HRMS method. NIBSC 03/192 is not compatible with a mass spectrometer as it contains sodium salts. Therefore, this company cannot provide the required product that fulfills our project activities’ needs. National Institute for Biological Standards and Controls (NIBSC), Potters Bar, Hertfordshire, EN6 3QC, Phone: + 44 (0)1707 641000.

mailto:techsupport@origene.com

3. Program Office efforts to seek potential offers:

Market research was performed using vendor information, internet searches and knowledge based on prior usage of the products meeting the performance parameters: (1) representation of pure protein standards that are compatible with a mass spectrometer; (2) past experience with existing vendors; (3) overall best value;

and (4) included special features. The results show that there are no known vendors for phosphorylated PTH standards. In addition, similar TSH alpha and beta protein standards from vendors such as OriGene and NIBSC are either not pure or compatible with our Thermo Scientific Q-Exactive Plus mass spectrometer. Only the proteins synthesized by BaChem meet the compatibility and compelling project requirements as mentioned in section 2a.

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:

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:

Contracting Officer Signature:

Certification Date:

Howard D.

Bish -S

Digitally signed by Howard D. Bish -S

Date: 2020.04.15 08:45:30

-04'00'