SSJ_Redacted.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:

Centers for Disease Control and Prevention (CDC) Attn: Muktha Natrajan 1600 Clifton Road, N.E., Mail Stop V2-3 Atlanta, GA 30329

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: Survey for Renaming and Standardization of Laboratory Tests to Support a Pandemic Response

b. Procurement Request (PR) Number (if available): HCPNB-2023-77345

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

a. Proposed Vendor: Brand Institute

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? Yes No

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

Rev. 5/14/19

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?

Brand Institute is the only company able to effectively assist CDC in surveying healthcare providers to determine appropriate laboratory test names. The company has expertise pertaining to pharmaceutical name safety and the identification of potential medication errors due to product nomenclature. Brand Institute has been in business for 27 years and is responsible for the development of over 4,000 names for pharmaceutical, healthcare and consumer clients/products. The company developed a proprietary risk scoring system to consider evaluating the confusion between two potential brand names and developed a method of Failure Mode and Effects Analysis (FMEA) for the pharmaceutical industry in evaluating the safety of dual brand naming. The process they used to create an index for classifying medication errors and a Taxonomy of Medication Errors useful for system analysis on individual medication error reports could also be used to classify errors in selection of the right laboratory test. Brand Institute is uniquely qualified in the comprehension and analysis of complicated nomenclature schemes (i.e., nonproprietary pharmaceutical nomenclature), analysis and determination of why name confusion occurs, and devising methods to solve these problems and prevent confusion. For pharmaceutical projects, they have conducted market research including a safety research component to assess the likelihood for name confusion and to stratify names based on risk, with the purpose of identifying which names to submit to regulators for approval consideration. Brand Institute has a unique ability to perform market research and to guarantee an acceptable rate of survey responses in a timely manner because Brand Institute maintains a global panel of healthcare respondents, including lab technicians, pathologists, epidemiologists, etc. with verified licenses on file. In addition, Brand Institute has a team of full-time recruiters who are able to invite new members to join their panel and/or solicit the contribution of specific specialists as needed. Rapid completion of this survey is important due to the ongoing coronavirus pandemic. Highly technical surveys often fail to gather sufficient information because of the difficulties in achieving adequate response rates. In 2020, Brand Institute developed, fielded, and provided data set analysis for 770 surveys and market research projects related to healthcare naming, including 557 projects that included a name safety component.

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

After Internet & independent market research we found there to be no other vendors who could provide all of the needs of this project, which include analysis and risk management of medical errors due to product nomenclature, ready source of participants for the survey, and research and safety analysis to support the development of names that support test selection of the right test at the right time with the right interpretation, thus preventing delay in testing and providing better patient care.

In our review we found a company (Insight Marketing Design, Inc.), with expertise in digital and traditional marketing, some pertaining to healthcare providers, but their efforts primarily focus on increasing brand awareness with consumers. They lack expertise in conducting surveys and safety research. We found another company (Brand Consulting Group, Inc.), with risk management and value enhancement to assist clients in meeting the requirements of internationally recognized management system standards. However, they do not have experience with conducting surveys or have access to pools of suitable healthcare participants.

We also identified a company (Advanced Survey Design), with experience in survey design and analysis, but lacking expertise in branding and safety research. Brand Institute is the only company who can provide all the needs for the project to ensure consistency and completion within the necessary one-year timeline.

3. Program Office efforts to seek potential offerors:

During our market research, we spoke with experts in the field and performed internet searches.

Insight Marketing Design, Inc. (https://insightmarketingdesign.com/) Insight has expertise in digital and traditional marketing, very little pertaining to healthcare providers. However, they lack expertise in conducting surveys and safety research.

Brand Consulting Group, Inc. (http://www.bcgiso.com/index.html) BCGI has the expertise for risk management and value enhancement to assist clients meet the requirements of internationally recognized management system standards. However, they do not have experience with conducting surveys nor have access to pools of suitable healthcare participants.

Advanced Survey Design (https://www.advancedsurveydesign.com/ ) Advanced Survey

Design has pertinent experience in survey design and analysis but lacks expertise in branding and safety research.

We discussed our findings with our expert collaborator and determined that the Brand Institute was the only company suited to provide the risk analysis, develop survey questions, provide a source of participants, and conduct the research and safety analysis to provide the services needed for a successful project.

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: Muktha Natrajan, PhD, MPH Center/Institute/Office COR/Program Official Signature:

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: Lauren Peel

Contracting Officer Signature:

Certification Date: Click here to enter a date.