DELAWARE HEALTH AND SOCIAL SERVICES DIVISION OF MANAGEMENT SERVICES “DMS - Serving Those Who Serve Delaware” STATE OF DELAWARE SPECIFICATIONS AND CONTRACT DOCUMENTS NO. HSS 10-082 FOR Buy UltraPerformance Liquid Chromatograph / Tandem Mass Spectrometer (UPLC MS/MS) Required for Use By Division of Public Health DELAWARE PUBLIC HEALTH LABORATORY Deposit WAIVED Performance Bond WAIVED Date Due: June 9, 2010 11:00 A.M. Local Time Questions must be submitted to sylvia.adams@state.de.us until 12:00 P.M. May 14, 2010. Q&A will be posted at http://www.dhss.delaware.gov/dhss/rfp/dhssrfp.htm no later than May 26, 2010. Delaware Health and Social Services Main Administration Building – Sullivan Street DMS - Procurement Branch 1901 N. DuPont Highway New Castle, Delaware 19720 INVITATION TO BID # HSS 10-082 Sealed bids for the purchase of an UPLC/MS/MS for analysis of Amino Acids and Acylcarnitines in dried blood spot specimens are requested by the Division of Public Health, Office, Delaware Public Health Laboratory. Questions must be submitted to sylvia.adams@state.de.us until 12:00 P.M. on May 14, 2010. Q & A will be posted at: http://www.dhss.delaware.gov/dhss/rfp/dhssrfp.htm no later than May 26, 2010. Sealed bids must be received at: Delaware Health & Social Services Main Administration Building – Sullivan Street Division of Management Services Procurement - Room # 262 1901 N. DuPont Highway New Castle, Delaware 19720 until 11:00 A.M. local time on June 9, 2010 at which time they will be opened and recorded. Please review the General Rules and Conditions and the General Requirements, which appear on the Delaware Health and Social Services (DHSS) website. NOTE: The following paragraphs from the General Requirements hereby become part of the General Terms and Conditions of this bid. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 16, 18, 19, 20a, 23, 24 and 25 Applicable forms to this bid: 1.) Bidder Signature Form 2.) Vendor Certification Sheet (Commodities only) 3.) Office of Minority and Women Business Enterprise Form All of the above documents and any addenda associated with this bid can be accessed on the DHSS website: http://www.dhss.delaware.gov/dhss/rfp/dhssrfp.htm NOTE TO VENDORS * Only one bid will be accepted from a bidder. Remember to check the DHSS website for any Addenda before sending your bid. * Your bid must be signed and all information on the Bidders Signature Form and Vendor Certification Sheet completed. * Include a detailed response to the specifications. * Bid total must include delivery, installation, warranty, service agreement and training or your bid will not be accepted. * Agency will review all bid proposals and evaluate same. * This contract may be extended up to five (5) years under the same terms and conditions, if both parties agree. DELIVERY INSTRUCTIONS * Your bid must have on the outside envelope the HSS contract number. IF THIS IS OMITTED YOUR BID WILL IMMEDIATELY BE REJECTED. * Under no circumstances will a bid be accepted that is late, delivered to the wrong building, signed for by a person other than a member of the procurement staff. To ensure that your bid is in the procurement office on the date and time specified, there are three (3) recommended methods of delivering bid proposals: o Hand Deliver o Federal Express o UPS FOR FURTHER BID INFORMATION PLEASE CONTACT: Buyer: Sylvia T. Adams Delaware Health and Social Services Main Administration Building – Sullivan Street DMS - Procurement – Room 262 1901 N. DuPont Highway New Castle, DE 19720 (302) 577-8778 sylvia.adams@state.de.us SPECIAL TERMS AND CONDITIONS/REQUIREMENTS The following supersedes the General Requirements where applicable 1.) Ordering Procedure: Successful contractors are required to have either a local telephone number within the (302) area code, a toll free (800) number, or agree to accept collect calls. Each Agency is responsible for placing their orders. This may be accomplished by written purchase order, telephone, fax or computer on- line systems. 2.) Billing: The successful vendor is required to “Bill as Shipped” to the respective ordering agency(s). Ordering agencies shall provide at a minimum the contract number, ship to and bill to address, contract name and phone number. 3.) Payment: The agencies or school districts involved will authorize and process for payment each invoice within thirty (30) days after the date of receipt. The contractor or vendor must accept full payment by procurement (credit) card and/or conventional check and/or other electronic means at the State’s option, without imposing any additional fees, costs or conditions. 4.) Product Substitution: All items delivered during the life of the contract shall be of the same type and manufacture as specified unless specific approval is given by DHSS-DMS-Procurement to do otherwise. Substitutions may require the submission of written specifications and product evaluation prior to any approvals being granted. 5.) Hold Harmless: The contractor agrees that it shall indemnify and hold the State of Delaware and all its agencies harmless from and against all claims for injury, loss of life or damage to or loss of use of property cause or alleged to be caused by acts or omissions of the contractor, its employees and invitees on or about the premises and which arise out of the contractor’s performance or failure to perform as specified in the Agreement. 6.) Force Majeure: Neither the contractor nor the ordering Agency shall be held liable for non-performance under the terms and conditions of this contract due, but not limited to, government restriction, strike, flood, fire or unforeseen catastrophe beyond either party’s control. Each party shall notify the other in writing of any situation that may prevent performance under the terms and conditions of this contract. 7.) Business License: The successful vendor must submit a current copy of their Delaware business license with their bid or show proof of initiating the process of application. To apply for a Delaware business license, call 302-744-1085 or apply online at www.revenue.delaware.gov. 8.) UNSPS Code: The State of Delaware is in the process of implementing a new financials system. The successful vendor must supply the United Nations Standard Products and Services Code (UNSPSC) for each item in their bid proposal. The UNSPSC can be accessed at www.top500.de/lexikon/unspsc.php. Failure to include the UNSPSC may be grounds for rejection of bid. 9.) Vendor Emergency Response Point of Contact: The awarded vendor shall provide the contact person’s name, address, telephone number and/or cell phone number of those individual(s) who can be contacted twenty-four (24) hours a day, seven (7) days a week where there is a critical need for commodities or services when the Governor of the State of Delaware declares a State of Emergency under the Delaware Emergency Operations Plan of April 2005. Failure to provide this information could render the bid as non- responsive. Contact Person: _________________________ Address: _______________________________ Phone Number: __________________________ Cell Phone Number: _______________________ INTRODUCTION: Delaware Public Health Laboratory wants to purchase an ultra-performance liquid chromatograph tandem mass spectrometer (UPLC/MS/MS) for the analysis of amino acids and acylcarnitines extracted from dried blood spot specimens in newborns. The testing population consists of two specimens from all Delaware newborns, birth rate ~12,500/year. We are looking for a complete testing system (equipment, software, computer, maintenance, training and support) that is easy to use, fits into the work operations of the laboratory and provides optimum sensitivity, and specificity across a large mass range. System will replace a present Waters Quattro Micro LC/MS/MS system that has been in used since 2002. System in this bid is expected to perform the workload of the existing system and be capable of additional testing for any of the second-tier testing presently developed for or in development for newborn screening applications. Analytes to be identified using this system include, but are not limited to: * Amino Acids – Phenylalanine, Methionone, Leucine/Isoleucine, Tyrosine, Citrulline, Valine, Arginine * Acylcarnitines – Free carnitine (C0), Acetylcarnitine (C2), Propionylcarnitine (C3), Malonylcarntine (C3DC), Butyrylcarnitine (C4), Methylmalonylcarnitine (C4DC), 3- Hydroxybutyrylcarnitine (C4OH), Isovalerylcarnitine (C5), Tiglylcarnitine (C5:1), Glutarylcarnitine (C5DC), 3-Hydroxyisovalerylcarnitine (C5OH), Hexanoylcarnitine (C6), Methylglutarylcarnitine (C6DC), Octanoylcarnitine (C8), Decanoylcarnitine (C10), Decenoylcarnitine (C10:1), Decadienoylcarnitine (C10:2), Tetradecanoylcarnitine (C14), Tetracedenoylcarnitine (C14:1), Palmitoylcarnitine (C16), 3-Hydroxypalmitoylcarnitine (C16OH), Stearoylcarnitine (C18), Oleoylcarnitine (C18:1) Additional analytes * Succinylacetone – For determination of Tyrosinemia, type I * Congenital Adrenal Hyperplasia Second Tier Testing Panel – Cortisol, A4- Androstenedione, 17-?Hyydroxyprogesterone, 21-Deoxycortisol, 11-Deoxycortisol SPECIFICATIONS: Definitions: LC = Liquid chromatograph UPLC = Ultra Performance Liquid Chromatograph MS/MS = Tandem Mass Spectrometer LC/MS/MS = Liquid Chromatograph and Tandem Mass Spectrometer CLIA = Clinical Laboratory Improvement Act MRM = Multiple Reaction Monitoring SIR = Selected Ion Recording Please address how your system meets / exceeds / does not meet EACH of these specifications in your bid response. Failure to respond will indicate you are unable to meet this specification in any manner. Provide detailed responses, rather than simple ‘yes/no’ responses wherever possible. A. GENERAL REQUIREMENTS 1. System capable of identifying all analytes indicated in the Introduction - Amino Acids, Acylcarnitines and additional analytes. 2. System capable of running from extracts derived from DBS (dried blood spot) specimens via derivitized or non-derivitized extraction methods. 3. All components of the system, including LC pump/ auto-injector and mass detector, are manufactured and serviced by the same company/organization. 4. Appropriate computer that has been tested by the instruments manufacturer to operate the LC/MS/MS system. 5. Approved for use in the United States 6. Uses microtiter plate technology. 7. Minimal hands-on time required for routine maintenance and instrument tuning. Please describe requirements. 8. System is successfully used in other states for similar newborn screening applications. 9. Capable of running, validating, and ensuring proficiency of established methods for Newborn Screening analysis without system modification. B. INSTRUMENTATION & EQUIPMENT 1. Ultra Performance Liquid Chromatograph a. LC system to be interfaced with tandem mass spectrometer and capable of running 160 patient samples and 16 Quality control samples (two 96 well microtiter plates), with the ability to be upgraded to run four to six microtiter plates. b. LC capable of flow rates of 0.1 uL/min. to 2.5 ml/min (with flush capabilities up to 5 ml/min.) c. LC system capable of operation at pressures of up to 15,000 psi, allowing use of sub-2 micron particles in 1-mm and 2.1-mm i.d. column formats under their optimal chromatographic conditions (flow rate and pressure) to achieve the separations characteristic of an Ultra Performance Liquid Chromatography (UPLC) system d. Auto-sampler with temperature controlled system allowing a range of 4?C to 40?C, capable of being programmed throughout the run. e. LC system includes a column heater operational from 5?C above ambient up to 90?C. Column selection capability and the capacity for up to 4 columns is available if required or for field upgrade if needed in the future. f. Start-up supplies/kit includes three columns, tubing kits, basic parts, and parts catalog. 2. Tandem Mass Spectrometer (MS/MS) a. Tandem mass spectrometer is a linear triple quadrupole instrument capable of all classical modes of MS/MS analysis (precursor ion scans, neutral loss, SIR, MRM). b. Automatic interface with HPLC and capable of running 160 patient samples and 16 Quality control samples (two 96 well microtiter plates) by one (1) Chemist with a processing time < 2.0 minutes per sample. c. Scan speed of up to 10,000 amu/sec in all modes (MCA, Continuum, and Centroid) without loss in sensitivity or mass accuracy. d. Mass detector with functional mass range of at least 2-2000 amu. e. Mass detector equipped with dual Electrospray (ESI) and Atmospheric Pressure Chemical Ionization (APCI) probes, allowing use in both modes in a single run. Switching between modes occurs quickly (<20 msec), without degradation of signal. f. Mass detector able to perform positive/negative switching in either/both ESI and APCI modes in a single run. Switching between positive and negative ionization modes occurs quickly (< 20 msec) with no degradation of signal. g. Ability to switch or adjust probes quickly (10-15 minutes) without loosing vacuum. h. Mass detector has a dual orthogonal source design as well as cone gas (a counter-current flow of nitrogen) to provide the ruggedness necessary for reproducible analysis of “dirty” sample matrices over multiple injections. i. Sample cone able to be removed for cleaning without venting the instrument. j. The instrument is capable of acquiring data in MRM or SIR mode using a minimum dwell time of 5 msec per channel with inter-channel/interscan delay at no more than 5 msec between modes, without degradation of signal. k. Air cooled turbomolecular pump that does not require external chilling device. The rotary pump, working under normal conditions requires the oil changed once a year. l. Allows tuning of instrument automatically through software controlled events and also manually in real-time. Both methods can generate reports of the assessment of the instrument and an option to hold further testing if user-defined criteria are not met. m. Calibration and validation reports should be able to be printed and electronically stored for use in QA/QC documentation. n. Start-up kit including two probes (APCI and ESI, or equivalent), tubing kits, basic parts, and catalog. Include cost estimates for yearly replacement parts and components, and detail probes to be provided in proposal. 3. Software Manager Interface a. MS/MS operating software controls all components of the LC/MS system and allows data processing concurrent with sample analysis. b. Rapid and simple export of data in multiple formats (including tab delimited) for records and reporting of results on a variety of platforms. c. Reporting software included that will be able to produce individual reports for each sample and are customizable to allow individual reporting options for any state submitting samples. Each report should include sufficient demographic information in order to meet CLIA requirements as a stand-alone report. d. Ability to track all control and standard values, and produce reports to evaluate trends and establish ranges, in order to meet requirements of CLIA. e. Capable of producing a tab-delimited export file that will be compatible with Natus MSDS data system. C. DELIVERY AND INSTALLATION 1. Specific instructions delivered to laboratory upon award of the bid, detailing specific space, temperature, electrical, and venting requirements of the system. 2. Delivery of all necessary equipment must occur no later than 30 days after submission of the purchase order or by specific arrangement. Installation must occur no later than 10 working days by the vendor after notification of site readiness. 3. All ancillary pneumatic and electrical cables, cords, gauges, filters, lines, etc. must be supplied so that the instrument is operational upon installation. 4. Installation must include the entire instrument set-up and a demonstration to ensure that the system is in complete operational condition. On-site introductory training of up to four DPH Laboratory staff members must be provided to assure that staff can operate and maintain the system satisfactorily. D. TRAINING 1. On-site training upon installation 2. Technical training must be included for one laboratory staff member to attend manufacturer's comprehensive course to learn operation, maintenance, and basic repair and trouble shooting of the instrument. If travel is required, all costs for travel, lodging and meals are to be covered by the vendor. 3. Training shall commence within a period of 60 days after installation at no additional cost to the Division. E. SERVICE AND SUPPORT 1. Two year comprehensive maintenance contract that shall include all services necessary to maintain the instrument throughout the period. This shall include all parts, labor, travel, lodging and software updates. 2. In order to facilitate repairs, systems shall be modular to ensure that repairs can be performed by modular replacement of major systems (i.e., critical components, power supplies, pumps, PC boards, etc.) rather than by multiple component troubleshooting and repair. 3. Application support must be provided in a timely manner with a telephone response time of 8 working hours by a service technician after initial contact is made by DPHL staff. On-site response must be no greater than 72 hours including delivery of necessary repair/upgrade parts. 4. Service must be provided by a factory trained engineer. 5. During the specified period covered by the maintenance contract, the offeror is expected to provide upgrades and/or replacements as they become available, as well as any corresponding training associated with such. F. SPECIAL CRITERIA 1. References from three states that are using the same equipment to identify amino acids and acylcarnitines on dried blood spot specimens obtained from newborns. References from states also using the equipment for succinylacetone or steroid testing are preferred. Please include name of institution, contact name, contact information, and analytes being tested. 2. No payment will be processed until the Delaware Public Health Laboratory personnel are satisfied that the testing system (UPLC, MS/MS, hardware and software) are functioning according to declared specifications. Final acceptance shall occur upon delivery of undamaged goods meeting the manufacturer's published specifications; in the event that the delivered goods are defective, damaged, or incomplete, the State of Delaware shall have fifteen (15) days from delivery of the goods to inspect them and notify vendor in writing of their defective, damaged or incomplete condition and reject the goods. In the event that vendor fails to promptly repair or replace such goods, vendor shall refund to the State the full amount paid for the goods. 3. PLEASE ADDRESS THE EXTENT YOUR SYSTEM MEETS EACH OF THE ABOVE SPECIFICATIONS LISTED IN THIS INVITATION TO BID. Bid # HSS 10-082 Vendor Name: ________________________ TOTAL COST PAGE (Must be all inclusive – product cost, delivery, installation, training, warranty, service agreement) Total Cost must be all inclusive: Total Cost should include cost of all components of the requested system, UPLC, MS/MS, Hardware and Software required to run and produce reports, and two- year maintenance contract. Total Cost: $_______________________________ All Bidders: Please include 2 Originals and 4 Copies of your bid. This should include any pamphlets or additional materials bidder wants to be taken for consideration. REMARK: PLEASE ADHERE TO THE ABOVE SPECIFICATIONS AS LISTED IN THIS INVITATION TO BID. DEVIATIONS FROM THESE SPECIFICATIONS WILL NOT BE ACCEPTED. 1