JA - 0011750122 - Redacted.pdf

OTHER THAN FULL AND OPEN COMPETITION FOR AN

ACQUISITION UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

Department:

I. BACKGROUND:

The service of material listed on for competition is precluded for the reasons indicated below on this justification for other than full and open competition, in accordance with:

a. FAR 13.106-1(b)(l)(i): states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one (1) source if the Contracting Officer determines that the circumstances of the contract action deem only one (1) source reasonably available.

b. FAR 13.106-3(b)(3)(i): this memorandum explains the absence of competition for this acquisition, as only one (1) source will be solicited for this requirement (or for a portion of the requirement) and the requirement is not expected to exceed the simplified acquisition threshold.

II. DESCRIPTION OF ITEM OR SERVICE:

a. Manufacturer Details: Provide original manufacturer’s name (if a Sole Source manufacturer distributes via dealers, include dealer information in (b) as well). Company Name:

b. Manufacturer’s Dealer / Representative Details (if applicable):

Name:

Point of Contact:

E-mail & Phone Number:

c. Provide a description of the item or service required (include its intended use and the required delivery date (RDD) / period of performance (PoP)):

Estimated Cost RDD / PoP: 1 Oct 22 - 30 Sep 23

Description:

Perform laboratory services on demand for the following tests: caffeine, Factor 8 activity, heparin anti XA LMWH, heparin anti XA UNFR, methotrexate, sweat chloride collection, PFA Col-ADP, PFA-Epi, Von Willebrand assay, retic count (auto), sed rate, CBC/PLT, D-dimer, APTT, PT, fibrinogen, tacrolimus, path consult (frozen), consult on referred slide, ref consult with slide prep, SP stain GRP3, GIP-PCR, B. pertussis, Bordetella PCR, HSV1&2, Men/Enc panel (PCR), RP2.1-PCR resp panel, Mycoplasma pneeun (PCR), C. trachomotis (AMP-P), N.

gonorrheae (AMP-P), MEP-PCR.

III. THE DETERMINATION FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION IS BASED ON THE FOLLOWING (select all that apply):

Only One Responsible Source (i.e. Original Equipment Manufacturer (OEM) technical representative)

Limited Source (i.e. multiple OEM authorized technical representatives)

Brand Name Sole Source (i.e. OEM replacement part)

Brand Name Limited Source (i.e. multiple OEM authorized part distributors)

Unusual and Compelling Urgency (i.e. urgent requirement, work stoppage, mission critical)

a. Section A:

(1) Restrictive Rights. The source has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required. Explain what rights are restricted, why the restrictive rights make the required item or service available from only one source, and why another company could not satisfy the Government’s need.

(2) Exclusive Licensing Agreements. The item or service is only available from the

OEM, or there is only one authorized distributor or technical representative for the OEM.

Identify the OEM and explain the circumstances surrounding why the item or service is only available from the OEM. OR identify the distributor(s) / authorized technical representative(s) for the item or service. Provide evidence of the exclusive licensing agreement as an attachment to this document.

(3) Form, Fit and Function. The required items are direct replacement parts / components for existing equipment and must be compatible in terms of form, fit and function with existing equipment / configurations. Provide the following information:

(a) Make and Model Number:

(b) Explanation of how direct replacement parts / components must be compatible with existing equipment (i.e. reagents & analyzers, electrical system of medical equipment, etc.).

Identify the direct replacement parts / components and explain the circumstances surrounding why the item(s) is needed and how it's compatible with existing equipment.

(4) Unique Features. Similar products lack features that are necessary to meet the

Government’s minimum needs (i.e. Beckman WA-96 Plus Analyzer vs Becton Phoenix M40

Analyzer). Identify the required features that are lacking from the competitor’s product:

✔ (5) Other Reasons. Other reason not identified above. Provide details on mission impact if requirement is not solicited from only one source or Brand Name.

The requested testing through CHKD is either only performed at that facility locally in the area (ie sweat chloride collection and special coagulation testing) or as back-up methods to in-house testing that become unable to perform due to reagent shortage or analyzer downtimes. All requested testing is ordered as STAT or ASAP.

b. Section B:

Brand Name. Item required must be a brand name product, or feature of a product particular to one manufacturer. Discuss why you are precluding consideration of a product manufactured by another company. Describe how the particular brand name, product, or feature is essential to the Government’s requirements and why a “brand name or equal” purchase description cannot be used (see FAR 11.104). Describe how market research indicates other companies’ similar products or products lacking the particular feature do not meet, or cannot be modified to meet, the agency’s needs.

c. Section C

Unusual and Compelling Urgency. The supplies or services are of such unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. Urgent

Requirements are supplies or services that will result in work stoppage, or are mission critical and the routine processing time would result in injury to the Government. The determination that the procurement for the above item / service is an urgent and compelling requirement is based on the following:

(1) Date on which the requirement was first identified:

(2) Required delivery date / period of performance: 1 Oct 2022

(3) Explanation of why delivery / commencement of services by the date mentioned above is required: Explain the impact to the mission if the date above is not met, any special circumstances or conditions that exist which validate the requirement as “urgent,” estimated production lead time for the item, etc.

Delay in contract award would directly affect patient care in a negative aspect. Unable to access local testing is a mission critical cause that will adversely affect NMCP and the outlying clinics.

(4) If appropriate, include any additional pertinent information. Explain how the

Government would be seriously injured.

IV. CERTIFICATIONS / APPROVALS

a. Department Representative / Technical Reviewer Requirements Certification: I certify that the facts and representation under my cognizance which are included in this justification are complete and accurate to the best of my knowledge and belief.

b. Contracting Officer Requirements Certification: I certify that the justification is accurate and complete to the best of the Contracting Officer’s knowledge and belief.

✔ The anticipated cost to the Government will be fair and reasonable.