554-Mass Spectrometer
COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C25919Q0281_1 Posted Date: May 30, 2019 Original Response Date: July 1, 2019 Current Response Date: July 1, 2019 Product or Service Code: 6630 - Chemical Analysis Instruments Set Aside (SDVOSB/VOSB): SDVOSB NAICS Code: 334516- Analytical Laboratory Instrument Manufacturing Contracting Office Address Regional Procurement Office West, Network Contracting Office 19 (NCO 19) Rocky Mountain Acquisition Center Department of Veterans Affairs 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Place of Performance Rocky Mountain Regional VA Medical Center (RMR VAMC) Laboratory (113) 1700 N. Wheeling St, Aurora, CO 80045 All components of the LCMSMS instrument system must be delivered to VA ECHCS, Laboratory (113), Rocky Mountain Regional VAMC in Aurora, CO. The instrument must be assembled to operational status per instrument specifications at this address by the Contractor. 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; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular 2005-101 10/26/2018. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a small business size standard of 1,000 Employees. The Network Contracting Office 19 (NCO 19) is seeking to purchase a Mass Spectrometer and Ultra High Performance Liquid Comatography (UHPLC). All interested companies shall provide quotation for the following: Line Item Description Quantity Unit Price Total Price 0001 Contractor shall provide the necessary UHPLC and mass spectrometry hardware, gas generator, compressor, uninterruptible power supply, computer hardware, software, access to necessary compound libraries/databases, application notes, technical support and training for an integrated liquid comatography tandem mass spectrometry (LCMSMS) instrument system 2 EA 0002 Extended Manufacturer Warranty 2 Years 0003 Travel and On-site Training 1 EA 1. Scope Contractor shall provide the necessary High Performance Liquid Comatography, HPLC and mass spectrometry hardware, gas generator, compressor, uninterruptible power supply, computer hardware, software, access to necessary compound libraries/databases, application notes, technical support and training for an integrated liquid comatography tandem mass spectrometry (LCMSMS) instrument system suitable for: Development of screening and confirmation tests and panels for urine/blood toxicology including pain medication monitoring: Urine oxycodone, oxymorphone, 6-AM-, morphine, codeine, fentanyl, hydrocodone, hydromorphone, morphine, norfentanyl, buprenorphine, norbuprenorphine, methadone, EDDP, tramadol, naloxone, amphetamine, noramphetamine, benzodiazepine group, ketamine, cannabinoids (THC). 25-Hydroxyvitamin D2 (OHD2), 25-Hydroxyvitamin D3(OHD3) testing; Ethyl Glucuronide (ETG)/Ethyl Sulfate (ETS) testing Operating two HPLC column methods independently, or up to 4 HPLC columns when using tandem injection techniques with up to two mass spectrometers if they can fit in the available space of the toxicology laboratory. Labor saving automation/software with high toughput specimen processing Transmission of results to the electronic medical record via an interface is crucial for timeliness and accuracy of reporting 2. Definitions 2.1 Integrated liquid comatography tandem mass spectrometry (LCMSMS) instrument system: Includes the necessary HPLC (> 600 bar pressure) and mass spectrometry hardware, gas generator, compressor, uninterruptible power supply, computer hardware, software, access to necessary compound libraries/databases, application notes, technical support and training suitable for the analysis of the common clinical tests described above. 2.2 Labor saving automation/software and high toughput: The overall process which results in a reduced turnaround time for reporting results, while reducing technologist effort to achieve the same. This can be best achieved by advances in automation involving software or hardware at all steps of the preanalytical and testing process. This includes the ability of the instrument software to proactively perform self- diagnostics to detect potential instrument problems, sample injection using multiplexing techniques, ease of review of quality control data, software innovations in data (result) analysis and interfaced reporting of results to the VA s electronic medical record/LIS (VISTA). All software that is used on the analyzers shall be approved by the VA ISO (Information Safety Officer) and OI & T (Office of Information and Technology) before purchase if it requires communication with the VA network. High toughput: Due to the high volume of testing needed, maximizing the toughput is an important consideration. Toughput is defined as the number of daily urine specimens/tests that can be run during a single working shift, using RMR s laboratory developed test (LDT) method. 2.3 Multiplexing: Multiplexing increases toughput of the system as elution of the analyte is slightly offset in time for each column to take advantage of the speed of the mass spectrometer. Multiplexing shall also allow the ability to run two independent methods in tandem on the mass spectrometer(s). In practice, this would mean each method would utilize two HPLC columns for tandem injections and up to 2 mass spectrometers could be used provided they fit in the available space. A two instrument system (LC/MSMS) would also serve as back-up for each other and contribute towards improved toughput and reduced downtime. 3. General Requirements The Contractor shall fully satisfy the below listed requirements: 3.1 The Contractor shall provide all upgrades to the equipment hardware including UPS and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at Rocky Mountain Regional VA Medical Center within 60 days of issuance to the commercial market. 3.2 All equipment shall be in current production. Current production shall mean that the mass spectrometry model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are unacceptable. 3.3 Contractor shall provide equipment that will perform satisfactorily at temperatures between 60 and 85 degrees Faenheit and a relative humidity between 20 to 85 percent. 3.4 Contractor s offered LC/MS/MS system(s) shall conform to the Rocky Mountain Regional VA Medical Center existing toxicology bench space (about 6 linear feet with a depth of approximately 3 feet and space for service behind the instrument). Equipment shall work with existing electrical and venting capacity. 3.5 Contractor shall provide technical advice during validation of instrument. 4. Hardware Contractor shall provide all necessary hardware for an integrated LCMSMS system(s) . HPLC system, with multiplexed sample injection capability is required. The proposed HPLC system(s) shall have capability to run two independent test methods simultaneously and have ability to use tandem injections in a system that shall fit into the existing space (about 6 linear feet). The HPLC columns shall be switchable by software to direct the column effluent to the mass spectrometer as required for multiplex analysis. Labor saving features which enhance toughput and save technologist time are required. The mass spectrometer shall be a triple quadrupole instrument capable of performing laboratory analysis by MSMS methods and shall have sufficient sensitivity to easily perform testing of the analytes described in Paragraph 1 above in a clinical setting that can pass the DMPM proficiency testing survey by the College of American Pathologists. Ionization shall be possible in ESI or equivalent modes. The mass spectrometer shall be able to switch between positive and negative ionization modes. APCI (Atmospheric Pressure Chemical Ionization) mode if available, is desirable. Sensitivity: The laboratory uses primarily urine dilute and shoot methods is 1:20 dilution of urine and inject 5 uL of sample into the HPLC. Detection limits shall be met by the instrument mass spectrometer detector system. See table below. Sensitivity Table Urine Analyte Amt injected on column Lowest calibrator ng/mL LOD = Limit of detection Oxycodone 1.25 pg 50 Morphine 1.25 pg 50 Fentanyl 0.05 pg 2 If the HPLC and mass spectrometer are from different manufacturers the contractor shall include all necessary parts to deliver a fully functional multiplexed LCMSMS instrument system. These parts include, but not limited to, tubing connections, switching valves, routers or other networking cards as necessary. Hardware requirement also includes the necessary computer, uninterruptible power supply, monitor, printer, connecting electrical and network cables and all other parts as might be required for producing clinical test results. The hardware shall include all other components required to produce clinical toxicology results in a health care environment. 5. Software Contractor shall provide all necessary software to operate the integrated LCMSMS system(s), perform multiplexed HPLC separation, mass spectrometry data acquisition, analysis and analyte quantitation, and to produce printed and electronic result reports for clinical toxicology use that can also be electronically interfaced with the VA s electronic medical record (VISTA). If a directly interfaced instrument exists with this LIS system or tough a Data Innovations middle-ware, please provide details. The software shall be capable of controlling the connected HPLC instrument and the mass spectrometer as an integrated unit. The software shall provide sample injection multiplexing capability. The software shall have features to allow full access to all system functions during method development and troubleshooting but shall have capability to restrict access to certain functions during production runs. These security features could be assigned by the Supervisor and shall have at a minimum, e.g. different access level for technologists. The ability of the software to expedite result analysis shall be discussed. We need tee (3) licenses per instrument to fully operate the instrument(s) (one to run the instrument and two additional licenses for remote viewing of results). If required for reporting and identification of Scope analytes, the software shall include access to a mass spectrum library or database for identification of unknown drugs. System shall have enough data storage capacity to either hold patient data for two (2) years or have an ability to back-up on CD/DVD or equivalent. It is highly desirable that already developed comatography and mass spectrometry methods (application notes) are supplied with the software for screening and quantitation of pain management drugs in urine, blood and body fluids, and for the screening and confirmation of drugs of abuse in urine, OHD2, OHD3, ETG, ETS. If such methods have been developed by the Contractor, please list drugs that are included in your method and the biological matrix that can be tested. The Contractor-supplied method (application note) shall include comatography conditions, compound optimization parameters, and acquisition and quantitation methods. The software shall include a flexible report writer for generating qualitative and quantitative reports for drug screening and confirmation. The report writer software shall allow for customization of reports. Flagging of individual results based on user defined criteria shall be available. 6. On-site training and application support Contractor shall provide on-site training to at least tee (3) VA laboratory employees at the time of installation to include training on the operation of the system, data manipulation, preventive maintenance and basic trouble shooting of the new instrument. Contractor shall provide additional focused off-site training for two VA employees dealing with the general principles and operation of the instrument. Contractor will be required to provide ongoing technical support as described in detail below, in section 6.1. Contractor shall provide on-site consultation with method development and with method validation support. This consultation shall be over and above the on-site training and shall be directed to answer specific, technical questions that Rocky Mountain Regional VA laboratory personnel might have. During the initial method validation period, contractor shall work with the Rocky Mountain Regional VA laboratory to create result reports for reporting DAU screening, DAU confirmation and quantitative drug analysis results and also OHD2, OHD3, ETG, ETS. Specifics of these reports will be discussed during the actual method validation period but they shall satisfy laboratory reporting standards. Cost of travel for the Contractor shall be included in the price for all on-site support and training. No separate billing shall be made for travel of contractor personnel. 6.1 Warranty and Service Contractor shall cover all components of the LCMSMS system for at least one year under warranty, even if an individual component is from different manufacturers than the Contractor. The warranty coverage shall start on the date when the LCMSMS system is fully operational at the Rocky Mountain Regional VA site, and not on the date of signing the contract or at the delivery of components. To be fully operational the instrument shall meet manufacturer s operating standards, including demonstration of the reported IDL (Instrument Detection Limit). Representatives of the Contractor and the Rocky Mountain Regional VA laboratory will have to certify in writing the date when the instrument is operational. Additional warranty coverage for all components shall be available at additional cost, starting at Year Two, or 12 months after the LCMSMS system became operational. The warranty shall include a technical assistance or support center shall be available by telephone hot-line Monday tough Friday (M-F) with a maximum call back response time of four (4) hours. On-site service, if required, shall be provided within 24-48 hours following determination that site service is required, excluding weekends and Federal holidays. Contractor shall be able to provide equipment service M-F between 7:00 5:00 pm for hospital-based systems, excluding weekends and Federal holidays. Scheduled preventative maintenance calls shall occur at a frequency to meet the minimum manufacturer s requirements to keep the equipment in optimal operating condition. Every notification for a repair service call shall be treated as a separate and new service call. As part of the warranty, Contractor shall perform emergency repair service on-site within forty-eight (48) hours of the time of notification of the malfunction. Contractor shall provide technical support service to assist in troubleshooting during normal business hours. In addition, to above the Contractor shall furnish a service incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following: Date and time notified; Date and time of arrival; Serial number, type and model number(s) of equipment; Time spent for repair; Description of malfunction and repair; and Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 7. Security Requirements The C & A requirements do not apply, and a Security Accreditation Package is not required per accompanying completed form: Appendix A, VA Handbook 6500.6. 8. Other Pertinent Information or Special Considerations. Being a clinical laboratory, we are required to perform large volume of testing is required without interruption in clinical service. Therefore, the availability of prompt service is an important consideration. 9.a. Identification of Non-Disclosure Requirements. Contractor might have access to proprietary VA information in the form of analytical methods developed in house. Contractor will not have access to any patient information. 9.b. Packaging, Packing and Shipping Instructions. Delivery and unpacking of all instrument components are the responsibility of the Contractor. 9.c. Inspection and Acceptance Criteria. James B. Bloom, the COR for this contract, will be responsible for certifying that the work is performed on time and to standards, and will also be responsible to assure the inspection and acceptance of products and services, with the understanding that a demo period or trial is not considered inspection of the product. 9.d. Facilities. The Contractor shall assess RMRVAMC s site for suitability for equipment installation and provide RMRVAMC s representatives with detailed electrical power and ventilation requirements of LCMSMS instruments. Contractor shall work with RMRVAMC s laboratory staff and engineering department to determine instrument compatibility with existing power and ventilation in the toxicology laboratory. 10. Period of Performance. This SOW is for the outright purchase and installation of the above described equipment. No additional deliveries are expected after the initial delivery of selected LCMSMS system. However, initial and extended warranty service will be required for the lifetime of the instrument as described in paragraph 6.1 of this document. Addendum to FAR 52.212-1 Instructions to Offerors Commercial Items Site Visit: An optional site visit will be held on June 13, 2019 at 9:00 AM Mountain Time (MT) at the Rocky Mountain Regional VA Medical Center, 1400 Wheeling St., Aurora, Colorado (See Attachment RMRVAMC MAP). All potential offerors (including consultants, subcontractors, manufacturers, and suppliers) are encouraged to attend this meeting to familiarize themselves with the Government s requirement. Offerors shall enter tough the Main Concourse and report to the VA Police station with a valid Government issued ID. Please wait at the Emergency Department waiting area and Ben Bloom (COR) will escort you to the laboratory. All visitors should park in the South Parking Garage attached to the Main Concourse. Floors 2-5 of the garage can be used, and the main concourse can be accessed via the elevator or stairwell. Technical Capabilities: To assist the Contracting Officer in determining if the equipment is technically acceptable, Offerors shall provide the following information with their quotes. Failure to include this information shall result in making the Offeror ineligible for contract award. Sub-Factor 1: Submit equipment literature. Sub-Factor 2: Submit a concept drawing showing that all equipment will fit in a space that is 9ft(w) x 4ft(d) x 10ft(h) and conforms to the Rocky Mountain Regional VA Medical Center existing toxicology bench space (about 6 linear feet with a depth of approximately 3 feet and space for service behind the instrument). Sub-Factor 3: Limit of Detection. Submit a report for sample test results with evidence that the instrument s sensitivity is within the limits described in the table below. Urine Analyte Amt injected on column Lowest calibrator ng/mL LOD = Limit of detection Oxycodone 1.25 pg 50 Morphine 1.25 pg 50 Fentanyl 0.05 pg 2 Due to the difficulties in comparing instrument sensitivity, we request that the Instrument Detection Limit (IDL) as measured with 20 fg of reserpine injected on column (10 replicates) be Offerors shall provide a mailing address where the Government will be able to send specimens for the Offeror to perform quantitative analysis of the analytes listed. Offerors shall return the test results to the Government as evidence of the offeror s instrument s sensitivity. Offerors shall not exceed the cost of $58.00 for the subject tests. If an Offeror exceeds the $58.00, then the Government will only reimburse up to $58.00. (End of provision) Addendum to FAR 52.212-2 Evaluation -- Commercial Items (Oct 2014) This procurement is being conducted pursuant to FAR Part 13 procedures. The Government intends to award a contract resulting from this solicitation to the responsible offeror whose quote, conforming to the solicitation, is technically acceptable and the lowest price that is found to be fair and reasonable. To determine technical acceptability of the offer, the Offeror s Mass Spectrometer, Ultra High Performance Liquid Comatography (UHPLC) equipment must meet the following criteria. Sub-Factor 1: Equipment literature substantiates that the offered equipment meets the salient characteristics described in the Statement of Work. Sub-Factor 2: Submit a concept drawing showing that all equipment will fit in a space that is 9ft(w) x 4ft(d) x 10ft(h) and conforms to the Rocky Mountain Regional VA Medical Center existing toxicology bench space (about 6 linear feet with a depth of approximately 3 feet and space for service behind the instrument). Sub-Factor 3: Report of testing results for sample test substantiates that the offered equipment performs within the limits of detection described in the table below. Urine Analyte Amt injected on column Lowest calibrator ng/mL LOD = Limit of detection Oxycodone 1.25 pg 50 Morphine 1.25 pg 50 Fentanyl 0.05 pg 2 The Government will evaluate the lowest-priced technically-acceptable offer for price reasonableness. Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision) Basis of Award This procurement is being conducted pursuant to FAR Part 13 procedures. The Government intends to award a contract resulting from this solicitation to the responsible offeror whose quote, conforming to the solicitation, is technically acceptable and the lowest price that is found to be fair and reasonable. 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: FAR 52.212-1, Instructions to Offerors -- Commercial Items (Oct 2018) FAR 52.212-3, Offerors Representations and Certifications Commercial Items (Oct 2018) Offerors shall 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 (May 2019) The following subparagraphs of FAR 52.212-5 are applicable: Subparagraph (b)(1), (b)(2), (b)(4), (b)(6), (b)(7), (b)(8), (b)(9), (b)(25), (b)(27), (b)(28), (b)(29), (b)(30),(b)(31), (b)(32), (b)(33), (b)(34), (b)(35), (b)(42), (b)(48), (b)(54), (b)(57), (c)(1), (c)(2), (c)(4), (c)(8). FAR 52.222-54, Employment Eligibility Verification (Oct 2015) FAR 52.224-1, Privacy Act Notification (Apr 1984) FAR 52.224-2, Privacy Act (Apr 1984) FAR 52.228-5, Insurance Work on a Government Installation (Jan 1997) FAR 52.232-19, Availability of Funds for the Next Fiscal Year (Apr 1984) VAAR 852.203-70, Commercial Advertising (Jan 2008) VAAR 852.215-71, Evaluation Factor Commitments (Dec 2009) VAAR 852.203-70, Commercial Advertising (Jan 2008) VAAR 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (Jul 2016) (Deviation) VAAR 852.232-72, Electronic Submission of Payment Requests (Nov 2012) VAAR 852.237-7, Indemnification and Medical Liability Insurance (Jan 2008) VAAR 852.237-70, Contactor Responsibilities (Apr 1984) VAAR 852.271-70, Nondiscrimination in Services Provided to Beneficiaries (Jan 2008) FAR 52.227-14, Rights in Data General (May 2014) FAR 52.227-19, Commercial Computer Software License (Dec 2007) All quotations shall be sent via email to bai.perney@va.gov. This is an open-market combined synopsis/solicitation for products as defined herein.A A The Government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes shall 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:" Offeror shall list exception(s) and rationale for the exception(s). Submit all questions regarding this solicitation in writing via e-mail to the Contracting Officer, Bai Perney, bai.perney@va.gov no later than June 18, 2019 at 2:00 PM, MT. Submission of quotes shall be received not later than July 1, 2019 at 2:00 PM, MT, to baiperney@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).
36C25919Q0281 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19
5/30/19, 6:46 PM