A13. Brand Name Justification - Artel PCS_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 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:

Division of Laboratory Sciences Chamblee Campus 4770 Buford Hwy 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: Artel Pipette Calibration System (PCS) to include PCS instrument, software, Laptop, Printer, Security Suite, Validation Guide, Installation, and Training.

b. Procurement Request (PR) Number (if available): 00HCUGDC-2023-78165

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

a. Proposed Vendor:

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:

In accordance with FAR 13.106-

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-

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-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-

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?

Our laboratories are seeking a non-gravimetric option for pipette calibration. The gravimetric options on the market require the use of an analytical balance and they require that you are able to adequately control for temperature and humidity fluctuations in the laboratory to avoid adverse impact on the results obtained. Due to the design of our laboratories, we are unable to completely control for temperature and humidity fluctuations within the laboratory. The Artel Pipette Calibration System (PCS), available from Advanced Instruments, LLC, is the only non-gravimetric product that we found that is a complete, closed pipette calibration system. The fact that the PCS is a closed system eliminated the need to monitor and adjust for temperature, humidity, and/or pressure. Additionally, the Artel PCS is the only option that we found that provides complete documentation, data management, audit trails and facilitates compliance to ISO 17025:2017. This documentation and audit trail is required in the Tobacco Products Laboratory as a condition for its ISO 17025:2017 accreditation.

Rev. 5/14/19

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

The Streck Pipet Verification Service (PVS) was considered, but the reagents used for this system are not provided by an accredited provider for pipet calibrations.

Streck PVS does not meet the ISO 17025:2017 requirements for the Tobacco Products Laboratory. Artel is an accredited provider which is critical for regulatory compliance (ISO, CLIA). The PCS and reagents are traceable to the National Institute of Standards and Technology (NIST) and meet the ISO and CLIA requirements for pipette calibrations.

The Rainin SmartCheck was evaluated, but the SmartCheck system only provides verification and not calibration of the pipettes. The SmartCheck system uses gravimetric methods requiring additional instrumentation, training, and time. Artel is a standalone instrument that provides verifications and 10-data-point calibrations in less than 3 minutes with minimal training. Artel PCS calibration method is compliant with ISO 8655-7. also evaluated. The service would require a yearly expense of approximately $10,000/year to calibrate all the laboratory pipettes in one DLS laboratory. The Artel system would be a onetime expense and would provide the laboratory with the ability to verify the accuracy and precision of a pipette between calibrations and prior to use. The Rainin calibration service needs to be scheduled weeks in advance ,and it is a 3-day process to perform all laboratory pipette calibrations. Having an Artel system in the laboratory provides the flexibility to perform calibrations on select pipettes at any time it is needed. This ensures the laboratory always has access to a calibrated pipette and

3. Program Office efforts to seek potential offerors:

Across two branches, research was performed to find non-gravimetric pipette calibration systems. Division personnel spoke with various vendors, reviewed literature, performed internet searches and queried other laboratory personnel at meetings and other scientific gatherings.