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Workstation CHRONECT Symbiosis Plus 250 bar UHPLC system with online SPE capability

Waiver type - Procurement: Nonavailability

Agency: CENTERS FOR DISEASE CONTROL AND PREVENTION (7523) • Product Service Code (PSC) : 6640 | Last Modified: 09/05/2023

Procurement Summary

The item being procured is a Workstation CHRONECT Symbiosis Plus 250 bar Ultra-High-Performance Liquid Chromatography (UHPLC) system with online SPE capability. This workstation includes multiple pumps, autosampler, injector, SPE analysis compartment and software, and is connected to a mass spectrometer. The workstation is used to remove contamination and isolate chemicals of interest such as per-and polyfluoroalkyl substances (PFAS) and polycyclic aromatic hydrocarbons (PAHs), for the accurate and precise analysis of biospecimens like serum and urine. For example, for urine analysis, the 250-bar system is sufficient because in general urine is available in larger volumes than blood. Also, because of salts and other chemicals present in urine, the 250-bar system is typically best as the smaller diameter systems tend to clog with the particulates in the urine. The Workstation CHRONECT Symbiosis Plus 250 system is the only system fully compatible with Division of Laboratory Systems’ (DLS) current systems and methods and provides an on-line solid phase extraction that can exchange the Solid Phase Extraction (SPE) cartridges in a way that is completely synchronized with the operation of mass spectrometer data collection. The exchange of cartridges is needed to ensure validity of the analytical results because of the complexity of complex biological matrices. The new Symbiosis on-line SPE system with supported software suits the needs of DLS method of systems considered, this is the only workstation that can replace an outdated, non-serviceable make and model instrument that is failing and is currently used in the Organic Analytical Toxicology (OAT) Branch of CDC. Spark Holland dba. iChrom is the only manufacturer and distributor of this specific workstation. This workstation supports methods under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that are extensively validated and published in peer-reviewed manuscripts using the requested workstation configuration. Any change to the workstation configuration would require extensive time and financial effort to re-validate methodology, thus resulting in significant delays in analysis and reporting of results. For policymakers, health scientists, and the public, access to timely and accurate human data from the approved CLIA methods is critical to track and understand the potential effect on diseases such as cancer and identify and evaluate ways to minimize the health impact of chemicals like PFAS and PAHs.

Waiver Rationale Summary

The item being procured has components manufactured in the Netherlands, Switzerland, and Germany. The Workstation CHRONECT Symbiosis Plus 250 bar Ultra-High-Performance Liquid Chromatography (UHPLC) system with online SPE capability is needed for this requirement. The Workstation CHRONECT Symbiosis Plus 250 bar Ultra-High-Performance Liquid Chromatography (UHPLC) system is the only system fully compatible with Division of Laboratory Systems’ (DLS) current systems and methods, and provides an on-line solid phase extraction that is capable of exchanging the Solid Phase Extraction (SPE) cartridges in a way that is completely synchronized with the operation of mass spectrometer data collection. The exchange of cartridges is needed to ensure validity of the analytical results because of the complexity of complex biological matrices. The new Symbiosis on-line SPE system with supported software suits the needs of DLS method and is cost efficient. The instrument being procured is required to replace outdated, non-serviceable make and model instrumentation that are failing. CLIA approved laboratory methodology has already been extensively validated using this instrument configuration. Any change to the instrument manufacturer would require an extensive time and financial effort to re-validate methodology that is unacceptable due to current project deadlines. Further, iChrom/Spark Holland is the only manufacturer and distributor of this instrument. Spark Holland is the only vendor able to provide this product because they have exclusive rights to sell these products in the US. iChrom/Spark Holland has the only Field Engineers certified by Spark Holland B.V. and Axel Semrau as having the demonstrated training for installing, repairing, and preventive maintenance on all iChrom/Spark Holland components and systems. Spark Holland is the only organization that maintains Original Equipment Manufacturer (OEM) spare parts for Spark Holland instruments in the United States. iChrom Solutions/Spark Holland is the only organization that maintains consumables for the systems and components in the United States.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

No

Was a sources sought or Request for Information issued?

No

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

09/01/2023

Procurement Instrument Identifier (PIID)

75D30123P17629

Solicitation ID

75D301-23-Q-77195

Procurement Stage

Post-solicitation

Expected Maximum Duration of the Proposed Waiver

Instant Delivery Only

Waiver Coverage

Individual Waiver

Funding Agency

CENTERS FOR DISEASE CONTROL AND PREVENTION