A16 - Intent to Sole Source (Market Research).pdf

Market Research Report

Agilent Technologies Inc.

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Program / Project Name:

Author(s):

Report Date:

Organization:

PSC & NAICS Code:

Estimated Value:

Key Team Members

Per FAR Part 10, the objective of conducting market research to arrive at the most suitable approach to acquiring, distributing, and supporting supplies and services. Market research requires formal documented research before a requirement documents are written or solicited. The results of market research should help determine whether sources are capable of satisfying the agency’s requirements, determining whether commercial or non-commercial items are available to meet requirements, and to determine whether the requirement should use any small business programs and explain the analysis of the information gathered. Specifically write an analysis of the efforts to find small businesses in accordance with Part 19 and E.O. 13985 for underserved entities and the results of the efforts. When two or more small businesses are likely to submit an offer, heavy consideration must be given to set aside the procurement for small businesses. The contracting officer may use market research conducted within 18 months before the award of any task or delivery order under a BPA or IDIQ contract if the information is still current, accurate, and relevant. Market research sources include Acquisition Gateway (www.gsa.gov/tools-overview/buying-and-selling-tools/acquisition-gateway ) and GSA’s Market Research as a Service (MRaS).

A. Service/Supply Description

Include a description of the service/supply addressed by this market research report.

The program is in need of new and replacement MS/MS, GC, HPLC, and QTOF instruments for laboratory operations within the Division of

Laboratory Sciences (DLS) at CDC. This is in keeping with DLS's mission to provide high quality laboratory support and analytical measurements that inform public health decisions. This new technology will enable fast processing and precise, accurate, and reliable measurements of samples in a robust, timely, and consistent manner for high sample preparation throughput for various activities across

DLS, including chemical threat agent exposure, tobacco and volatiles, protein biomarkers, and other biomonitoring activities.

B. Background:

Provide a short narrative on the requirement this service/supply will support or fulfill.

This is a new procurement. DLS currently houses multiple Agilent systems and a contractual agreement for instrument maintenance.

However, these advanced instruments will improve the laboratory's high throughput and capabilities to efficiently and reliably test for chemical threat agent exposure, tobacco and volatiles, protein biomarkers, and various other biomonitoring activities.

C. Potential Supplier Information:

Provide a list of potential vendors and known sources with the capability to provide the service/supply required. Identify if the business is large or small.

334516

CDC/NCEH/DLS

3/8/2022

Amy Hobson

Acquisition of Agilent Triple Quad MS, GC, LC, and Q-TOF Systems https://www.acquisition.gov/far/part-19#FAR_Part_19 http://www.gsa.gov/tools-overview/buying-and-selling-tools/acquisition-gateway http://www.gsa.gov/tools-overview/buying-and-selling-tools/acquisition-gateway

MS/GC/LC Systems

1. Agilent Technologies distributes the Agilent 8890 GC System equipped with 7693A Autoinjector, coupled to a 7010B Triple Quadrupole MS/MS system and is a large business. The Agilent GC- MS/MS System is equipped with multiple integrated features that address the Protein Biomarker Laboratory’s need for continued high sample throughput, productivity, and reliable results and the Vaping Laboratory’s need for robustness. It provides precise gas and temperature control. Its chromatographic peak retention time reproducibility is less than

0.0008 minutes and its area reproducibility has less than a 0.5% relative standard deviation. This is very critical for our current method because we are monitoring over 30 fatty acid analytes in one chromatographic run and retention time of each analyte peak needs to be well controlled. Moreover, the microchannel-based electron pneumatics control structure on the GC provides protection against gas contaminants, and thus, extends the lives of consumable parts. This is very beneficial because our GC column are customized and require long production time. Therefore, it is crucial to maintain the quality and lifespan of the columns and other replaceable parts.

Contamination and neutral noise can be eliminated by the heated monolithic quartz gold quadrupole and triple axis detector, respectively. Also, the system is compatible with three different electron ionization (EI) sources and has multiple sample introduction methods. This versatility will optimize method efficiency for both ongoing methods and future method development. In addition, the High Efficiency Source (HES) for this GC/MS system produces at least 20 times on average as many ions as the preSvious generation and can increase the MS signal by ten-fold, down to attogram-level detection, which reduces the sample injection volume typically required by one-tenth. This consequently reduces the amount of biological sample we need per sample analysis and the amount of sample and chemical waste produced. The system also comes with an updated software which increases the efficiency of method editing but full training of the software is not necessary since our lab analysts have been previously trained on the basic functionalities of the software.

Additionally, its JetClean self-cleaning ion source greatly reduces or even eliminates the need for manual source cleaning, greatly reducing the maintenance required for upkeep and significantly extending the time between required ion source cleanings. Moreover, it has a large capacity auto sampler for higher throughput, built in controls to ensure security of data, as well as advanced GC technologies like inert flow path which helps enable lower detection limits, backflush option which reverses the flow in the column so that any remaining components are forced out through the sample inlet, and early maintenance feedback to minimize downtime and support planned maintenance. The Agilent 6470 Triple Quadrupole LC/MS includes a 20 kV High-Energy Conversion Dynode for increased sensitivity (lower LOD), VacShield Technology for replacing Ion Transfer Capillaries without system venting (reduces system downtime), a curved hexapole collision cell (reduces detector background noise and takes up a smaller laboratory footprint), and is certified for hardware/software/firmware compatibility with the Agilent 1290 Infinity II LC System. The Agilent 6495 Triple Quadupole LC/MS includes the 3rd Gen, All-metal iFunnel (increases sensitivity 8-10x and reduces matrix contribution to baseline), 20 kV High-Energy Conversion Dynode for increased sensitivity (lower LOD), VacShield Technology for replacing Ion Transfer Capillaries without system venting (reduces system downtime), and is certified for hardware/software/firmware compatibility with the Agilent 1290 Infinity II LC System. The Agilent 7000D Triple Quadrupole GC/MS includes the InertPlus Electron Ionization (EI) Source with JetClean self-cleaning (significant reduction in background noise and reduces frequency of system venting and manual hardware cleaning), heated gold quadrupole, triple-axis HED-EM detector (increased sensitivity), dynamically-ramped Iris, fast venting for quick system downtime when performing repairs or maintenance, and is certified for hardware/software/firmware compatibility with the Agilent 8890 GC System. The Agilent 1290 Infinity II LC System includes a High-Speed Binary Pump (rated for two mobile phases up to 5 mL/min, <0.5% ripple, and 1300 bar backpressure), a Multisampler that contains a refrigerated (4 ̊C) sample storage “hotel” for 14 x 96-well PCR plates (1344 samples) and a three solvent multiwash (eliminates sample carryover from injection), and a Multicolumn Thermostat that can store and heat up to 8 LC columns (temperature range of 20 ̊C below ambient to 110 ̊C), and is certified for hardware/software/firmware compatibility with the Agilent 6470, 6495, or 6546 systems. The 6546 LC/Q-TOF includes 5 orders of magnitude in-spectra dynamic range, maintains 30K (low mass) and 60K (high mass) resolutions independent of acquisition rate or ion abundances, contains the Quadrupole Resolved All Ions (Q-RAI) capability that allows for compound fragment identification in MS mode, acquisition rates of 3 – 30 Hz in targeted MS/MS and data independent Q-RAI modes, consistent <1 ppm mass accuracies for extended periods of time to increase data stability, and is certified for hardware/software/firmware compatibility with the Agilent 1290 Infinity II LC System.

2. Shimadzu Corporation of North America, Product: Shimadzu (GCMS-TQ8050 NX); large company; This manufacturer distributes a comparable instrument to the Agilent 8890/7693A/7010B system. The GCMS-TQ8050 NX instrument has enhanced sensitivity; however, it only allows the femtogram level quantitative analysis, unlike the Agilent 8890/7693A/7010B system which provides attogram level detection limits. Thus, the increased sensitivity of the Agilent 8890/7693A/7010B system allows for ultra-trace level analysis and less sample needed. Additionally, the GCMS-TQ8050 NX can only accommodate 60 samples in its autosampler, while the Agilent 8890/7693A/7010B can hold 150 samples. The higher capacity autosampler for the Agilent system allows for longer unattended operation. Moreover, the Shimadzu system does not have self-cleaning technology for the ion source cleaning which is not preferable due to the intensive labor involved in the cleaning procedures, it does not have the capability of backflushing which provides shorter analysis times, longer column life, less carryover, and extended maintenance-free operation, and acquiring the Shimadzu would require software familiarization and training time by the end user, as well as may require intensive method development activities to integrate this instrument into the ongoing projects which could cause delays in project productivity. It is crucial to obtain a GC-MS/MS system that can provide the best functionality that allows continuation of the analysis of NHANES and other biomonitoring studies per CLIA requirements in high throughput environment. Therefore, this company cannot provide the required product that fulfills our project activities’ needs and does not offer the best value for the government.

3. Thermo Fisher Scientific, Inc. Product: TSQ 9610 Triple QuadrupoleGC-MS/MS System; large business. This instrument also distributes a comparable instrument to the Agilent 8890/7693A/7010B system. The TSQ 9610 system offers a larger sample capacity autosampler than the Agilent 8890/7693A*7010B system, 240 vials vs 150 vials respectively. However, like the Shimadzu GCMS-TQ8050 NS, the TSQ 9610 Triple Quadrupole BC-MS/MS system does not offer self-cleaning technology for the ion source cleaning which is not preferable due to the intensive labor involved in the cleaning procedures, it does not have the capability of backflushing which provides shorter analysis times, longer column life, less carryover, and extended maintenance-free operation, and acquiring the Shimadzu would require software familiarization training time by the end user, as well as may require intensive method development activities to integrate this instrument into the ongoing projects which could cause delays in project productivity. Therefore, this company cannot provide the required system that meet our project needs in various biomonitoring activities of the project.

LCMS Prep Systems

1. Only two companies sell a full prep LC-MS system: Agilent prep system and Shimadzu Nexera prep system. Both are on GSA schedules: GS- 07F-0564X334516 (Agilent) and GS-24F-0031M (Shimadzu). Both can be customized with semi-prep pumps, prep pumps, uv-vis detectors, prep column compartments, and liquid handlers. Both systems have similar ranges in sampling size, wavelength range, flow rate and pressure ranges with Agilent having more range in all areas over Shimdazu. The only ability that Nexera has over Agilent is a recycle feed feature. The price points are almost identical for the same instrument setups. However, the system has a limited lower level for injection volumes, 6 column capacity in the column compartment, flow rates up to 150mL/min. Since the nature of ERB research is so varied, from the micro scale to large macro scale and compound polarities ranging from hydrophobic to lipophobic, the branch requires a system with the widest specifications possible. Additionally, because ERB plans to hook this new LC system up to existing Agilent systems, including an array diode and mass spectrometer, the Agilent LC is required for compatibility and continuity.

declared.

Market research was completed 03/08/2022. No commercial factors were considered, and no outside influences or conflicts of interest are

Contract Specialist Signature & Date:

Contracting Officer Signature & Date:

E. Market Intelligence/Industry Analysis:

Describe the date(s) market research was done and any available commercial factors. Discuss use of Best-in-Class (BIC) for the OMB preferred governmentwide contracts (mechanisms).

F. Conclusions and Recommendations:

Summarize your analysis with recommendations.

When considering the purchase of a new GC-MS/MS (triple quadrupole MS) system for the current GC-MS (single quadrupole MS), the 3 GC-MS/MS systems reviewed were comparable, but 2 of the systems lacked key requirements. The Shimadzu GCMS-TQ8050 NX System didn’t have the large capacity autosampler to accommodate the high throughput methods for routine projects in the Protein Biomarker Laboratory for the NHANES and other biomonitoring studies. Additionally, as previously mentioned, it lacks the backflush feature and self-cleaning capability, has lower detection capabilities, and would require lengthy software familiarization training. The Thermo Fisher Scientific TSQ 9610 Triple QuadrupoleGC-MS/MS System would be suitable for project needs; however, like the Shimadzu, it lacks the self-cleaning technology for the ion source cleaning which is preferable due to the intensive labor involved in the cleaning procedure, it has no backflushing capabilities and requires software familiarization training for the end user. Therefore, Thermo Fisher Scientific and Shimadzu cannot provide the required product that fulfills our project activities’ needs.

When considering the purchase of a new preparative LCMS system, the only other system available on the market with prep capabilities besides Agilent is the Shimadzu Nexera. The price points are almost identical for the same instrument setups. However, the system has a limited lower level for injection volumes, 6 column capacity in the column compartment, flow rates up to 150mL/min. Since the nature of ERB research is so varied, from the micro scale to large macro scale and compound polarities ranging from hydrophobic to lipophobic, the branch requires a system with the widest specifications possible. Additionally, because ERB plans to hook this new LC system up to existing Agilent systems, including an array diode and mass spectrometer, the Agilent LC is required for compatibility and continuity.

Preparer Name & Title Program Office Signature

CDC/NCEH/DLS

Additional Guidance

Sources:

FAR Part 10- Market Research

HHS Market Research Directive

Author(s): Identify the name of person(s) completing the report.

Report Date: Include the date the report was completed. The date should be in the MM/DD/YYYY format.

Organization: Identify the CDC program office

PSC and NAICS Code: Include the PSC and NAICS Codes and descriptions for the procurement

Estimated Value: Include the dollar value including all options

Key Team Members: Include the name of all key personnel who contributed to the market research along with their contact information.

A. Service/Supply Description: Include a brief description of the service/supply addressed by this market researchreport. The report should detail what is the service and supply, when it is required, mandatory source requirements, and the current contract vehicles that are available.

B. Procurement Background: Provide a short narrative on the requirement this service/supply will support or fulfill. Include information relevant to the award such as whether this is a new requirement, if the requirement was previously resourced via contract, contract number and description, is relevant market research already available based on similar procurements, and contract types used in past procurements.

C. Potential Supplier Information: Per FAR Part 8.002, except as required by 8.003, or as otherwise provided by law, agencies shall satisfy requirements for supplies and services from or through the mandatory government sources and publications. Provide a list of potential vendors and known sources with the capability to provide the service/supply required. Use this section to identify the number of sources contacted; identify whether they were large business, small business, small/ disadvantaged business, Section 8(a) business, woman-owned business, government/non-government. Describe efforts to locate sources and explain the rationale used to exclude sources.

E. Market Industry Analysis: Describe any available commercial factors. Current market pricing must be used to analyze the market industry. Members are encourage to use such research tools such as Acquisition Gateway and Best-In-Class Contracting Vehicles. In accordance with FAR Part 10.001 (vi), members must take advantage (to the maximum extent practicable) of commercially available market research methods in order to effectively identify the capabilities of small businesses and new entrants into Federal contracting that are available in the marketplace for meeting the requirements of the agency. The Dynamic Small Business Search can be used to conduct market research for small businesses. The analysis should include information on the availability of the service/supply, the demand for the service/supply, how many suppliers are in the market and what is the market share, analysis of the fair/reasonable market price for services/supplies within the industry, which may include an assessment of available price data, price ranges, known pricing issues, or an explanation of price variations? Explain if the price might be unstable.

F. Conclusions and Recommendations: Summarize your analysis with recommendations. Provide a brief description of the acquisition strategies to pursue (e.g., commercial acquisition, 8(a) direct, small business set-aside, sole source, full and open competition, Native American direct, or HUBZone). Provide potential existing contract vehicles that can be used to satisfy the requirement, Relevant risks to be considered as part of any source selection activities, specific contract terms and conditions, and any OCI concerns.

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