Attachment 003 Redacted BNO SSJ JandA.pdf

36C244-20-AP-3200 | LCMS-MS | Philadelphia VA Medical Center Request for Brand Name Only Sole Source Justification >SAT-$7M under FAR13.5

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME ONLY SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED

PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH

FAR 13.5

Acquisition Plan Action ID: 36C244-20-AP-3200

1. Contracting Activity:

Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh, PA 15215-1802

Purchase Request (VA2237): 642-21-315-0005 | Liquid Chromatography-Mass Spectrometry Analyzer | Corporal Michael J. Crescenz VA Medical Center (CMCVAMC), 3900 Woodland Avenue, Philadelphia, PA 19104-4551 | Contracting Agency: Network Contracting Office 4

2. Nature and/or Description of the Action Being Processed: Pathology and Laboratory Medicine, Chemistry and Toxicology section needs new equipment that can analyzer patient’s urine to detect and confirm drugs detected initially on a drug screen or drugs being prescribed to veteran patients to confirm the presence in random urine. This equipment will replace a 15-year-old instrument which is being used until a replacement is acquired. It is beyond the life expectancy of the analyzer. We are looking for a replacement that have minimal maintenance, prevents source contamination, possesses increased sensitivity, and significantly decreases in-source carryover to be able to detect and confirm the presence of drug analytes in human urine.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The following items comprise the Brand Name Only Requirement.

Item # Description/Part Number*

Qty Price per test Extended Amount

1 Kit* PTO QTRAP 4500 MD 1 2 Clinical LCMS (LC-MS System) 2 3 PPGs Chemical standards Kit (low-High Conc) 1 4 Triazine standard mixture 1 5 FG, Synergi 4U Fusion RP80 A 50X2 1 6 Peak Genius 1024 Nitrogen Generator 1 7 Part* Peak Dual Tap transformer 200-230 VAC 1 8 Configured EXIONLC AC System- no oven 1 9 Exion LC Column Oven 120 V 1

10 Sample Rack for DWP, SIL-20A/AC 1 11 MS office 2016 professional plus ISV Global Kit 1 12 MS Bench SCI 1 1 13 48WX36DX33H One Pointe Solutions Work Bench 1

14 Sciex university- Success Master MD 3 15 Multi Qunat 3.0 License- LIMS Compatibility 1 16 Alpha Worstation2020- TQ/QT 1 17 Monitor 27 inch (U2719D) 1 18 Triazine standard mixture 1

TOTAL:

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority):

Sciex QTRAP 4500MD is the only responsible source that can provide the quality and specificity that is required for the Toxicology confirmation testing at the CMCVAMC. The Turbo V Ion Source has a unique heater geometry that places the desolvation heaters (X2) orthogonal to the ESI Electrode. This specific design results in superior Sensitivity and Significantly decreases in source carryover. There is another specific part that comes with the QTRAP 4500 MD and it is the design of the curtain gas interface which prevents neutral gas and other ion clusters from entering the mass Spectrometer analyzer and has the advantage over the ion transfer tube designs that are prone to clogging. The QTRAP 4500 MD also has a QJET that is needed to capture the ions in the free jet expansion cloud behind the orifice and to transfer them to the lower pressure regions of the mass spectrometer (Q0, Q1, Q2, Q3) The Qjet Ion guide is an RF only quadrupole that focuses the ions into the lower pressure Q0 region while efficiently removing the gas molecules. The QJET coupled with the curtain gas and orifice design gives a rugged and robust advantage. Additionally, the QTRAP design with is a hybrid triple quadrupole/linear ion trap mass spectrometer gives one the ability to use both the triple quad and the ion trap scan functions on the same platform even with a single LC-MS/MS injection. In addition to MRM quant, the QTRAP system can be used to rapidly acquire MS/MS spectra for every detected peak (by MRM) that exceeds a threshold. Additionally, there is an onboard Library that allows inambiguous identification of the chromatographic peak. The quotation for the QTRAP system is highly specialized and all inclusive. Without the Sciex System, there would be unnecessary delays and duplication of costs. The Sciex system is a Medical Device Approved system and is highly regarded in the Toxicology confirmation world. All the Toxicology LCMS-MS laboratories local around the Philadelphia location, twenty out of twenty-five (20/25) labs are utilizing Sciex. The Sciex System is essential to the Government’s requirements for Drug Confirmation testing at CMCVAMC.

Sciex is the only manufacturer of an approved Medical Device System that has all the components and features required at CMCVAMC.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

NCO4 will release a Combined Synopsis Solicitation using a Brand Name Only Request for Quote method.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Price Reasonableness will be determined through competition on Beta System for Awards Management, Contract Opportunities website. Price reasonableness will be further determined the over 55% of the brand name items required for this acquisition have been determined reasonable through GSA Federal Supply Schedule competition and review of similar Federal Procurement Data System-Next Generation database awarded action.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

NCO4 reviewed the VA National Acqusition Center (NAC), Contract Catalog Search Tool (CCST) using the search terms “QJET”; “LCMS”; and “Mass Spectrometry” on 08-12-2020. Only the search for term “Mass Spectrometry” provided returns and of those none of the contracts that returned were relevant to the capabilities that CVAMC requires.

NCO4 posted a Request for Information on 06-09-2020 to Beta-System for Award Management (SAM), Contract Opportunities. Responses for this notice were due on 06-23-2020. Two Vendors responded. These were Ab Sciex (Other Than Small Business, OTSB) and Agilent Technologies (the incumbent vendor and OTSB ). Vendor Bruker Mass Spectometry requested additional information but did not provide a formal response to the RFI.

NCO4 reviewed the Vendor Information Page (VIP) database on 07-21-2020 using NAICS Code 334516 and search terms “LCMS MS”; “MS Analyzer”; and “QTRAP”. These searches yielded no results.

NCO4 consulted the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS) database using the NAICS Code 334516 and the search terms “LCMS MS”; “MS Analyzer”;

and “QTRAP” on 07-22-2020. The term “LCMS MS” yielded three vendors. The term “MS Analyzer” yielded 63 vendors. NCO released a Sources Sought Blind Carbon Copy email to 66 SBDS vendors on 07-22-2020 and recieved a response from 1 SDVOSB Vendor, Apex OmniSource, LLC.

This vendor was an authorized distributor for Scimadzu Scientific.

Following the information gleaned from the SDVOSB Vendor, NCO4 conducted a Sources Sought Notice to one hundred eleven (111) vendors on General Service Administration’s (GSA) electronic buy (e-Buy) database on 08-12-2020 and received responses from five (5) GSA Multiple Award Schedule, Scientific Management and Solutions, Laboratory Equipment Vendors. Abstract covering Vendor Responses follows. Only vendor, Ab Sciex met the technical specifics set forth by CMCVAMC. Abstract follows.

Quantitative MS/MS/MS can be performed using a unique scan where an MRM is performed and the MRM product ion is trapped in Q3 (using the LIT) – allowing for trap-based fragmentation to occur and create an additional product ion (or MS/MS/MS type ion). This is very useful when the MRM trace is showing high background, this additional level of selectivity has potential to enhance signal to noise by reducing the background. Again, this scan function can be combined into the same injection as the standard MRM targeted quantitation, allowing for a single injection workflow.

The LC-MS/MS instrument has a dual heater design with the 2 desolvation heaters located orthogonal to the ESI electrode. Heater temperature and gas flow are user controllable which facilitates LC effluent desolvation across a wide range of flow rates, prior to entrance into the high vacuum region.

This provides an advantage by Effective desolvation produces more ions from the ESI droplets with fewer neutrals resulting in better sensitivity.

The LC-MS/MS instrument includes an active-exhaust ionization source which uses a dry nitrogen/air gas to ensure maximum source cleanliness, uptime, and sustained performance and sensitivity.

Advantages and Benefits 1:

An LC-MS/MS ionization source must charge target analytes in the presence of liquid mobile phase, heat, current, and other sample matrix components. This process occurs in a confined, pressurized region. This environment can be a recipe for contamination which leads to more downtime, maintenance, and the potential for ghost peaks from ions recirculating in the source. Actively exhausting the source ensures long-term cleanliness, maximum uptime, and minimal maintenance.

The LC-MS/MS interface employs a single thin aperture which separates the vacuum chamber from atmosphere, and an N2 gas flow that runs counter-current to the ion beam entering the vacuum region.

Advantages and Benefits 2:

The counter-current gas flow works in conjunction with active exhaust to eliminate neutrals and decluster solvent molecules from the ionized material. This counter gas flow also removes adducts that may have formed during the ionization process. Adduct formation can interfere with good quantitation.

The LC-MS/MS instrument employs an RF-only guided quadrupole to move ions efficiently and to focus the ion beam into the mass analyzer region.

Advantages and Benefits 3:

An RF-only guided quadrupole reduces the need to retune compounds over time as it eliminates the need to use DC to steer ions for optimal transmission. RF/DC-designed interfaces require more frequent tuning because the rings/lenses used to steer ions with DC get contaminated causing the ion beam to move.

The LC-MS instrument enables scheduling of the source ionization voltage during the chromatographic run.

Advantages and Benefits 4:

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Mark E. Murray Ronald J. Kline Contract Specialist Contracting Officer

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Darlene Seminko Branch Chief

Commodities

RONALD J.

KLINE 152627

Digitally signed by

RONALD J. KLINE 152627

Date: 2020.09.09 12:59:13 -04'00'

MARK E.

MURRAY

1083666

Digitally signed by

MARK E. MURRAY

1083666 Date: 2020.09.09 13:35:50 -04'00'

Darlene Seminko 1648180

Digitally signed by Darlene Seminko 1648180 Date: 2020.09.11 10:32:02 -04'00'