Amendment 02 _ Brand Name Justification _ PPE PAPR.pdf

OPOAM 3013.106-1(b)(1) Sole Source Justification (SSJ)

For Simplified Acquisitions (over the micro-purchase threshold and up to the Simplified Acquisition Threshold (SAT) pursuant to FAR 13.106, including Brand Name

Sole Source Justification for Simplified Acquisitions (over the micro-purchase threshold and up to the SAT) Template Rev. 1/30/2018 1-1

SSJ No.: FY21-026

Date: _12/15/2020_______ PR Number: _____ RUAS-21-PE006_______

1. Nature and/or description of the item/service being procured and anticipated cost:

This requirement is to procure Personal Protective Equipment (PPE) PX5, Powered Air Purifying Respirator (PAPR) units and associated replacement filters manufactured by RPB Safety, Inc., to support dental and health care providers at United States Coast Guard (USCG) clinic facilities. PAPR systems are identified by the CDC as an appropriate COVID-19 mitigation strategy for medical providers. According to the CDC, “A PAPR is an air-purifying respirator that can be used to protect healthcare personnel (HCP) who may be exposed to aerosolized pathogens causing acute respiratory infections.” Dental practitioners, through dental cleanings, examinations, and restorative processes, are routinely exposed to aerosolized particles. Additionally, the risk of patient exposure is extremely high given the close contact required for dental procedures. Due to both the risk of exposure and the risk of spread, providing the highest level of protection possible to HCPs is a necessary priority.

PAPRs provide enhanced protection from aerosolized matter that result from the treatment process and enable clinicians to perform all examination and treatment functions while enabling the wear of dental/medical optical devices. PX5 PAPRs are requested to supplement existing equipment in use at CG clinics. The filter supplies will support both new PAPR units and will be compatible with existing PAPRs in use by medical providers.

The Independent Government Cost Estimate for this requirement is $300,000.

2. Sole Source Justification Rationale in accordance with FAR 13.106-1(b)(1).

__________ Only one source reasonably available.

__________ Urgent and compelling circumstances exists.

______ ____ Exclusive licensing agreement exists.

______X___ Brand name. If the brand name requirement applies to a portion of the procurement, please identify that portion.

___________ Industrial Mobilization ___________ Other. Explain:

OPOAM 3013.106-1(b)(1) Sole Source Justification (SSJ)

For Simplified Acquisitions (over the micro-purchase threshold and up to the Simplified Acquisition Threshold (SAT) pursuant to FAR 13.106, including Brand Name

Sole Source Justification for Simplified Acquisitions (over the micro-purchase threshold and up to the SAT) Template Rev. 1/30/2018 1-1

OPO intends to procure specific brand name PX5 PAPR in accordance with FAR 13.106-1(b)(1) because the PX5 is unique or highly specialized and is a brand name item peculiar to the Original Equipment Manufacturer (OEM) - RBP Safety. USCG currently utilizes PX5 PAPR in their medical and dental facilities and replacement filters and parts from other makes and models are not interchangeable. DHS, Office of Chief Readiness Support Officer (OCRSO) and USCG conducted market research on the following products: Flexair and 3M. The results of the market research indicate that other companies’ similar products lack the particular feature(s) required and do not meet, or cannot be modified to meet, the needs of USCG. Specifically, none of the other products were able to provide compatible replacement filters for existing Coast Guard equipment.

Procuring an alternate product other than PBR PX5 brand will require complete replacement with a significant increase in cost. This involves doubling the overall order to outfit each clinician with replacement equipment, developing new safety SOPs, validating that clinic instruments and operations are compatible with a different PAPR system, and conducting training across all clinic sites. The monetary costs of a change in equipment is estimated to include an additional $300,000 to replace all PAPR units to outfit each clinician. Additionally, a change to a new PAPR system would render existing PAPR equipment inoperable and would result in approximately $176K in waste for equipment that is no longer supported.

3. The anticipated price will be determined fair and reasonable based on one or more of the price analysis techniques described below in accordance with FAR Part 13.106-3(a)(2).

__________ Market Research.

_________ Comparison of the proposed price with prices found reasonable on previous purchases.

____X____ Current price List.

____X____ Comparison with similar items in a related industry.

____X____ Comparison to IGCE.

_________ Contracting Officer’s personal knowledge.

_________ Other.

4. Approval:

Contracting Officer Date