Combined_Synopsis-Solicitation Liq Spec.docx

Combined Synopsis-Solicitation for Commercial Items Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-06 effective July 12, 2021.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1,250 employees.

The FSC/PSC is 6515.

The Richard L. Roudebush Veterans' Administration Medical Center, 1481 West Tenth Street, Indianapolis, IN 46202 has a requirement for another liquid chromatography mass spectrometry(LCMS) equipment purchase.

All interested companies shall provide quotations for the following:

Supplies

Statement of Work Liquid Chromatography Mass Spectrometry

I. Scope The Richard L. Roudebush VA, Pathology and Laboratory Medicine Service, has a requirement for a liquid chromatography mass spectrometry(LCMS) equipment purchase.

The Toxicology department purchased our first LCMS five years ago in order to bring toxicology/urine drug testing in-house and save money by not sending samples out to contract labs. It is important for the Toxicology department to purchase a second LCMS as a back up to the original equipment and to provide the means to test more samples. The Toxicology department is in negotiations with VISN10 and the Cincinnati VAMC to run urine drug testing for their veterans. The second LCMS will enable us to run all samples, generate revenue from outside sources and expand our testing menu to better serve the veterans. This purchase must produce data and methods that are compatible with our current system (Shimadzu). The compatibility will allow us to maintain our Standard Operating Procedures without interrupting the continuity of care.

Contractor shall provide all equipment, accessories, installation, and training of the end users, offsite training for two personnel and a one-year warranty period. All equipment is to be new and state of the art, discontinued or used equipment will not be accepted. The instrumentation shall perform all analyses for the required tests with precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS). The system must utilize ultra-high pressure (performance) liquid chromatography (UHPLC) or Ultra-Performance LC (UPLC) coupled with mass spectrometry to analyze and identify drugs of abuse in clinical samples such as serum, urine, and saliva samples.

II. UHPLC/UPLC-MS/MS Basic Equipment Specifications

Instrument must be a tandem quadrupole, liquid chromatography mass spectrometer system configured for integrated UHPLC or UPLC-MS/MS analysis with the following minimum specifications, features, and accessories:

1. General

· The liquid chromatograph and the mass spectrometer must be part of a fully integrated system.

· The liquid chromatograph and the mass spectrometer must be serviced by the manufacturer.

· Integrated software should be able to operate both the MS and UHPLC/UPLC instruments from a single unified operating platform.

· The system should be capable of performing both Qualitative and Quantitative analysis in a single run.

· Manufacturer shall include, at no additional cost, installation, training, and technical support. Technical support shall include phone support, and on-site visits for follow up training.

· The contractor shall provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the Government. These enhancements to the contractor’s equipment shall be delivered and installed at the site within 60 days of their issuance or date of first commercial availability. The contractor shall at all times maintain compatibility of systems with whatever host LIS or TCP/IP interface is in place, especially when contractor software is upgraded.

2. Mass Spectrometer Interface

· The system shall be equipped with an electrospray ionization (ESI) source, heated to a maximum temperature of 400 degrees Celsius.

· Ionization source maintenance must be performed without breaking MS vacuum.

· To limit sensitivity loss from the elevated flow rates of UHPLC/UPLC, the ionization source design must allow for high efficiency ionization and desolvation at the high flow rates seen with UHPLC/UPLC. Designs should limit thermal degradation.

3. Mass Analyzer

· High resolution main analyzer quadrupoles should have a pre-filter design to keep main rods clean and to focus ions in phase into the main quadrupoles.

· Collision cell optimized for high speed data acquisition. Collision gas is Argon.

· The detector should be high efficiency, high sensitivity, and wide dynamic range photomultiplier or electron multiplier detector. Detector operates in a digital counting mode. Performance specifications of the detector should be detailed for evaluation.

4. Tuning

· System includes autotuning software functions.

· Autotuning optimizes BOTH positive and negative ion modes automatically.

· Autotuning optimizes all scan speeds automatically.

· A single solution tuning standard is used for production of positive and negative ions for tuning purposes for ESI (Electrospray Ionization).

· Autotune provides full automated tuning for mass axis calibration, sensitivity, and mass resolution.

5. Vacuum system

· A single multiport turbo pump drives the entire LCMS instrument.

· A single rotary (backing) pump drives the entire LCMS instrument.

6. Performance requirements

· MS/MS acquisition modes should include product ion scan, precursor ion scan, neutral loss scan, multiple reaction monitoring (MRM).

· MS acquisition modes should include selected ion monitoring/recording and full scan.

· Polarity switching is completed in </= 30 millisecond.

· Maximum acquisition speed is >/= 10,000 atomic mass units (amu)/sec [Daltons (Da)/s].

· Minimum dwell time is </= 3 millisecond.

· Minimum inter-channel delay is </= 5 millisecond.

· Lower end of Mass Range should be 10 m/z or less and the upper end of Mass Range should be 2000 m/z or greater.

· Maximum scan speed in full scan range and all scan modes should not result in loss of sensitivity.

· High Signal/Noise ratio is preferred with a minimum of >/= 180,000:1 (RMS) 1 pg reserpine, MRM transition

· Mass resolving power: R</= 0.7 FWHM (full width at half maximum).

7. UHPLC /UPLC System The UHPLC/UPLC system must meet these minimum specifications:

· System must consist of at least two pumps, degasser, autosampler, column oven with capacity for more than one analytical column, solvent selector valve, column selector valve and diversion valve.

· System must accommodate pressure suitable to support UHPLC/UPLC.

· System must have a pump design with high-pressure mixing. Low pressure mixing is not acceptable.

· Autosampler must have the capability for many vial types such as but not limited to: 1mL, 1.5mL, 96 and 384 well plates – both standard and deep well.

· Autosampler must have pH range of 1-14.

· Autosampler performance characteristics should be detailed and include: Carryover, injection cycle time, injection volume repeatability (precision) and accuracy, sample volume range.

· System to include a valve, controlled by the software, to divert the solvent flow prior to the Mass Spectrometer interface.

· System to include a valve, controlled by the software, to switch between two solvents for each pump.

· System to include a valve, controlled by the software, located in the column oven to switch between two analytical columns.

8. Software The software system must meet these minimum specifications, if optional software is offered must be clearly indicated with gains of function identified, illustrated, and priced:

· Software files must be compatible with Shimadzu .lcd files and Shimadzu .lcm files.

· Software must be able to control all components of the instrument: autosampler, UHPLC, gas and vacuum pumps, ionization source, Mass Spectrometer.

· Software must have security log-on features that protect from unauthorized viewing or editing of patient data.

· Software must allow for secure data archival and retrieval.

· Software package must allow the operator to process data while the instrument is in operation.

· Software must have the capability to flag established criteria like QA/QC parameters and transition ratios.

· Software must include customizable report formats that include all parameters of the LC/MS/MS output.

· Software to include LC maintenance and troubleshooting module.

· Middleware software, which is designed for the clinical setting, must be included and provided by the contractor that enables the operator to view all the data collected for a particular accession number. (provide examples)

· Software should include a monitoring mechanism for critical instrument performance parameters such as temperature, column pressure, etc.

· It is the responsibility of the Contractor to install, verify and maintain the compatibility of the middleware drivers (if applicable) with Data Innovations.

· Provide at least one workstation licenses for the primary software, middleware (if applicable).

· Provide barcode scanning of samples resulting in the formation of an accession table.

· Instrument software-LIS interface must communicate bi-directionally with Data Innovations using HL7 protocol.

10. Miscellaneous Hardware The hardware below must meet these minimum specifications:

· UPS (un-interruptible power supply) must be supplied by the contractor. The UPS at minimum should be able to maintain instrument power for such time as is needed to safely shut down the instrument or to maintain continuous operation for 30 minutes, whichever time is greater. Maintenance and repair will be at no cost to the government during the lease contract.

· Nitrogen and Air generator must be supplied by the contractor with gas flow capabilities up to 25L/min with an outlet pressure of 100psi.

· The nitrogen generator must produce laboratory grade nitrogen and dry air for LCMS applications.

III. Training The contractor will provide instrument training at the time of equipment installation and at least one time per year thereafter for the length of the lease at no charge to the government. The training shall include software and hardware.

· Provide initial in-depth training for two key operators off-site at the contractor’s facility.

· Provide annual training for one VA equipment operator.

· Provide on-site contractor operator training for all operators who will run the instrument and training provided for all applicable shifts.

· Provide initial in-depth middle-ware training for two key operators off-site at the contractor’s facility.

· Provide training for one VA middleware operator annually.

· Provide on-site middle-ware operator training for all staff on all shifts.

IV. Service Plan As part of this procurement action, the Department of Veteran’s Affairs is requesting proposals on a Premium Full-Service Maintenance Agreement to cover the instrumentation for four (4) one-year optional periods starting at the end of the initial 1st-year warranty period as an option. (Provide exclusions if any). The service plan must include replacement of all turbo and rotary pumps during Preventative Maintenance yearly call, if needed. The need will be decided by the Toxicologist. Services shall be performed between the hours of 8:00 a.m. and 4:30 p.m. Monday through Friday, except for Government holidays. Response time will be as soon as possible but within 24 hours. If prior approval is provided in writing by the VAMC, the service may take place outside of these hours. Services shall be performed on-site at the VAMC facility at 1481 West 10th Street, Indianapolis, IN 46202. Government equipment cannot be removed from the premises without receiving prior written authorization from the VAMC.

See the schedule for a list of equipment required.

No partial quotes will be accepted.

The period of performance is 30 days ARO.

Place of Performance/Place of Delivery Richard L. Roudebush VA Medical Center

Indianapolis, IN

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items”.

2. FAR 52.212-5, “Evaluation-Simplified Acquisition Procedures”.

3. 52.211-6, “Brand Name or Equal”

4. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” www.sam.gov registration is required to be complete at time of submission of response.

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” (Oct 2018).

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” (Jan 2021).

All quoters shall submit the following:

Vendor response shall include the following:

(a) company name

(b) address

(c) point of contact

(d) phone, fax, and email of primary point of contact

(e) DUNS number

All responses to this RFQ shall be fixed priced and Freight on Board (FOB) Destination.

All quotes shall be sent, be email only, to christopher.blazejewski@va.gov.

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

The following are the decision factors: Lowest Price, Technically Acceptable that must fully meet all salient characteristics.

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms, conditions.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission of your response shall be received not later than 12:00 PM EST on January 31, 2022, via email to christopher.blazejewski@va.gov.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact Chris Blazejewski via email only at christopher.blazejewski@va.gov VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 3 of 5 Original Date: 10/12/17 Revision 04 Date: 06/10/20