Sole Source Justification (00HCUGDD-2020-46994).pdf

Rev. 5/14/19

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 Office of Financial Resources 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: Waters sample preparation consumables including:

1. [70] Waters Acquity UPLC Column Part# 186004118

2. [30] nanoEase M/Z HSS T3 Column Part # 186009252

3. [1] Oasis HLB 96-well uElution Plate Part# 186001828BA

4. [10] Oasis PRiME HLB 1 cc Vac Cartidge Part# 186008055

5. [3] Waters Round Well Digestion Plate, Part# 186002481

6. [6] nanoAcquity UPLC PST (BEH) C10 Column, Part# 186003546

7. [6] nanoAcquity UPLC Symmetry C18 Trap Column, Part# 186006527

The purchase of these brand-name laboratory consumables is needed for the direct usage during sample preparation procedures for all CLIA regulated projects and methods in analysis of patient samples from various studies as part of activities in support of the Protein Biomarker Laboratories within the Clinical Chemistry Branch/Division of Labopratory Scienes. These items have been selected and evaluated to be used as key components in all CLIA regulated methods based on the high quality data results acquired from the use of these products.

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

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

a. Proposed Vendor:

Waters Technologies 34 Maple St, Milford, MA 01757 Email: customerservice@waters.com Phone: 1-800-252-4752

b. Estimated Procurement Amount:

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

If yes, provide schedule number:

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.”

mailto:customerservice@waters.com

☐ 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?

Protein Biomarkers Laboratory and Lipid Reference Laboratory within the Clinical Chemistry Branch of the Division of Laboratory Science participate in nation-wide studies, such as NHANES and PATH, to measure the levels of hormones, adducts, and urinary creatinine in order to assess the normal levels of these chemicals in population. The requested products are laboratory consumables and supplies needed for sample preparation and liquid chromatography analyses in related to CLIA compliant laboratory methods mentioned. As part of method development for these projects, specific chromatographic consumables and supplies have been selected and validated for product efficiency and other possible interference that could otherwise impact the quality of the laboratory data obtained. These lab consumables include specific brand and model sample solid phase extraction well plates, analyatical columns, extraction cartridges that are used for critical sample preparation procedures for different projects within the Protein Biomarkers Laboraotory. For example, the Acquity UPLC and nanoEase columns are needed to separate analyte in a chromatographic instrument before mass spectrometric analysis of the analyte. These model of UPLC columns were chosen due to great analyte separation and we were able to obtain high quality laboratory data as a result of the usage of the column.The ruggedness of these products and consumables have been fully tested during months of method validation for each method and therefore it is imperative to the continuous usage of these products to ensure continuity of measurements and consistency of data.

As a result, only the requested products from Waters can properly maintain the existing sample preparation procedures to ensure the quality and the reliability of the data acquired in compliance to CLIA requirements and following the Standard Operation Procedures (SOP) for all the methods.

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

As mentioned in section 2a above, the specific brandname laboratory consumables have been selected and used extensively during samples preparation procedures in established methods for analyzing patient samples within the US population. During method development stage of all laboratory methods, different laboratory products and consumables essential for sample preparation were extensively evaluated and compared for the best efficiency for carrying out the experiments for each method.

For example, other vendor such as Thermo Fisher and Phenomenex offer analytical columns with similar separation technology. Although the columns may share some common methodology in analyte separation, analytical results vary greatly by each brand column. As a result, the requested laboratory products have been selected based on the results of the extensive testing and series of validation procedures and determined to be the optimum for laboratory operation. Any attempt in using other brand-name and types of products and consumables used for our methods requires further method comparisons before they can be used for preparation procedures as required by CLIA regulation. This could result in serious delay in data reporting and potentially affecting the quality of the sample data obtained.

3. Program Office efforts to seek potential offerors:

Market research was performed using internet searches and knowledge based on prior usage of the products that meet the rquired performance parameters. The requested brandname items are the only items that fulfill the project requirements and Waters Technologies is the only vendor that can distribute the items requested.

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: May 28, 2020

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: