SOURCES SOUGHT
65 -- Human Papilloma Virus Testing
- Notice Date
- 3/18/2015
- Notice Type
- Sources Sought
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Western Regional Contracting Office, ATTN: MCAA W BLDG 9902, 9902 Lincoln Street, Tacoma, WA 98431-1110
- ZIP Code
- 98431-1110
- Solicitation Number
- W91YU0-15-T-JD03
- Response Due
- 3/31/2015
- Archive Date
- 5/17/2015
- Point of Contact
- Jose Domingo, (360)486-9806
- E-Mail Address
-
Western Regional Contracting Office
(jose.d.domingo.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The Western Regional Contracting Office (WRCO) is conducting a Sources Sought for Market Research purposes only. There is no solicitation available at this time. Requests for solicitation will receive no response. The Contractor shall provide a FDA approved Cost Per test for Molecular Diagnostics analyzers and reagents capable of running multiplex testing for qualitative detection and genotyping of the DNA of Human Papilloma Virus (HPV) at Madigan Army Medical Center (MAMC), Joint Base Lewis McChord, WA in accordance with the below DRAFT Statement of Work (SOW). The platform may not be limited to HPV detection and genotyping and may be expanded to include other PCR testing for other pathogens and capable of performing FDA approved HPV Genotype Test with specific functionality and performance-based requirements of the system. STATEMENT OF WORK 1. GENERAL: The Contractor shall provide a FDA approved Cost per test for Molecular Diagnostics analyzers and reagents capable of running multiplex testing for qualitative detection and genotyping of the DNA of Human Papilloma Virus (HPV) at Madigan Army Medical Center (MAMC). The platform may not be limited to HPV detection and genotyping and may be expanded to include other PCR testing for other pathogens. The contract is a 5 years (base plus 4 options years) HPV Genotype Test 2. ESTIMATED COST-PER-TEST HPV DETECTION AND SPECIFIC GENOTYPING: The contractor is required to furnish MAMC, the laboratory instrument(s) system(s), reagents, and UPS(s) to include detection kits for HPV Genotype Testing. The detection kits will be determined by user based on tests to be performed, on a fully automate amplification and detection for polymerase chain reaction (PCR) testing platform featuring sample in and results out capability necessary to operate the contractor's equipment, hardware and software upgrades, training for personnel and equipment maintenance necessary to fulfill the test requirements. MAMC will select the equipment and associated package tailored to its requirements and only will pay for the test assays run on the contractor's equipment (payment rate is at an established average quote mark cost-per test quote mark figure). 3. EQUIPMENT DNA OF HPV GENOTYPE TEST: The purpose of this solicitation is to identify salient characteristics of a Molecular Diagnostics instrument(s) capable of performing FDA approved HPV Genotype Test with specific functionality and performance-based requirements of the system. The proposal shall provide descriptive literature that meets the following specifications: Characteristics for DNA of HPV Genotype testing instrument(s) and Reagents: General instrument characteristics include being able to run HPV DNA based assays on a RT-PCR technology based platform in batch sizes of 24 or 96.. Bar-coded data entry capabilities. Test-specific reagents Capable of multiplexing- up to 6 detections per amplified sample. All in one compact, benchtop unit. A proprietary Kinetic Algorithm ensures results are positive, negative or invalid and growth curve analysis is unnecessary. B-directional interface for host connection to connect to LIS Functionality and Performance Specifications: An Internal Control/Quantitation Standard (IC/QS) incorporated into each individual sample and is carried through the sample preparation. Dual probe, single tube multiplex assay design with automatic internal control. Contamination control included in the kit to reducing the risk of cross-contamination. Not a separate reagent. Controls are included as part of the kit. Overnight operation capabilities from start of specimen to finish. Confined extraction processing to reduce aerosolization. Computer system (CPU, Monitor, Keyboard, Printer,), UPS for all instruments for the life of the instruments. The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste. The test may be used with self-collected vaginal swab specimens in a clinical setting, and male urine, from both symptomatic and asymptomatic individuals. The HPV test must use amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies (types) HPV 16 and HPV 18 while concurrently detecting the rest of the high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels. One test in one run, from one patient sample (1mL) eliminates the need for reflex testing and reduces the risk of QNS. Ability to destroy previously generated PCR amplifications to help significantly reduce the risk of false positive results or cross contamination without using bleach. All samples include an internal control, a beta globin gene, which is isolated concurrently and assesses cellular adequacy, extraction, amplification and detection for each individually processed sample testing. Functionality and Performance Specifications: Able to reuse reagents to avoid reagent waste. From 1 to 70 samples can be loaded on the instrument at one time. An Internal Control/Quantitation Standard (IC/QS) incorporated into each individual sample is carried through the sample preparation. Controls are included as part of the kit, not separately. FDA approved for parallel processing capabilities, with the ability to run multiple assays in parallel. Overnight operation capabilities. Instrument reagents are ready-to-use pre-packaged, bar-coded cassettes. Confined extraction processing to reduce aerosolization. Power characteristics 100 to 125 and 200 to 240 VAC Able to offer mirror backups B-directional interface for host connection to connect to LIS sending results to the LIS, but also able to send patient demographics to the instruments. Computer system (CPU, Monitor, Keyboard, Printer,), UPS for all instruments for the life of the instruments. The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste. The system should not require monitoring during a run and should be 100% quote mark walk-away quote mark system. LIS compatible KRAS, BRAF, and EGFR Genetic Testing 2. ESTIMATED COST-PER-TEST DNA OF KRAS, BRAF, EGFR TESTING: The contractor is required to furnish MAMC, the laboratory instrument(s) system(s), reagents, and UPS(s) to include detection kits for, KRAS, BRAF, and EGFR Genetic Testing. The detection kits will be determined by user based on tests to be performed, on a fully automate amplification and detection for polymerase chain reaction (PCR) testing platform featuring sample in and results out capability necessary to operate the contractor's equipment, hardware and software upgrades, training for personnel and equipment maintenance necessary to fulfill the test requirements. MAMC will select the equipment and associated package tailored to its requirements and only will pay for the test assays run on the contractor's equipment (payment rate is at an established average quote mark cost-per test quote mark figure). 3. EQUIPMENT DNA OF HPV, KRAS, BRAF, and EGFR TESTING: The purpose of this solicitation is to identify salient characteristics of a Molecular Diagnostics instrument(s) capable of performing DNA of KRAS, BRAF, and EGFR testing with specify functionality and performance-based requirements of the system. The proposal shall provide descriptive literature that meets the following specifications: Characteristics for KRAS, BRAF, and EGFR testing instrument(s) and Reagents: General instrument characteristics include being able to run KRAS, BRAF, and EGFR DNA based assays on one RT-PCR technology based platform in batch sizes up to 24. Bar-coded data entry capabilities. Test-specific reagents. Able to identify both low and high risk HPV at the same time. EGFR testing must be FDA approved. The EGFR Mutation Test should be a real-time polymerase chain reaction-based diagnostic test that identifies 41 mutations across exons 18, 19, 20 and 21 of the EGFR gene using multiplex PCR chemistry. The EGFR test should detect less than 5% mutant sequence copies in a background of wild-type DNA. EGFR, KRAS, and BRAF should have liquid, ready-to-use reagents provided in the test kit to increase testing efficiency. The BRAF V600 Mutation Test should detect the BRAF V600E mutation in formalin-fixed, paraffin-embedded (FFPET) human melanoma tissue. The BRAF Mutation Test should have at least 97.3% positive agreement in detecting the BRAF V600E (1799 T greater than A) mutation, which represents greater than ~85% of all BRAF mutations reported in the COSMIC database. KRAS testing should identify mutations in codons 12, 13 and 61 of the KRAS gene. All in one bench top instrument. B-directional interface for host connection to connect to LIS Functionality and Performance Specifications: An Internal Control/Quantitation Standard (IC/QS) incorporated into each individual sample and is carried through the sample preparation. Dual probe, single tube multiplex assay design with automatic internal control. Contamination control included in the kit to reducing the risk of cross-contamination. Not a separate reagent. Collaborating controls should be included as part testing from the same manufacturer. Overnight operation capabilities from start of specimen to finish. Confined extraction processing to reduce aerosolization. Computer system (CPU, Monitor, Keyboard, Printer,), UPS for all instruments for the life of the instruments. The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste. The system should not require monitoring/user intervention during a run and should be 100% quote mark walk-away quote mark system. The test may be used with self-collected vaginal swab specimens in a clinical setting, and male urine, from both symptomatic and asymptomatic individuals. One test in one run, from one patient sample (1mL) eliminates the need for reflex testing and reduces the risk of QNS. Able to destroy previously generated PCR amplification to help significantly reduce the risk of false positive results. Elimate the use of bleach solutions to prevent cross-contamination issues. All samples include an internal control, a beta globin gene, which is isolated concurrently and assesses cellular adequacy, extraction, amplification and detection for each individually processed sample testing. 6. SCOPE: MAMC anticipates the award using Federal Supply Schedule procedures. MAMC plans a Reagent Usage (Cost Per Test ) contract for use of the instrument, supplies, installation, training, and service of the equipment (for life of agreement). The Cost per-test price includes costs covering (a) equipment use(reagent rental), (b) detection kits, (c) all necessary maintenance to keep the equipment in good operating condition, (d) operational hardware and software upgrades, (e) off-site and on-site user training for government personnel, (f) yearly preventive maintenance per manufacturer's recommendations, (g) complete service support, (h) reagents delivery cost. Contractor is required to provide delivery and installation of equipment at no additional charge. All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with the FDA and manufacturer's guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein. The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability. All models shall perform satisfactorily at any laboratory temperature between 59 and 89 degrees F (15 and 32 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity less than 80% at 32C (89F) without condensation. An electronic operator's manual must be furnished with each model supplied. Trade-in of existing equipment will be negotiated at James A Haley, and not included in the scope of this contract. Site Preparation specifications shall be furnished in writing by the contractor as part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor. With all new equipment, Ownership of Equipment shall remain with the contractor for the life of the contract. All equipment accessories (hardware or software) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will remove the equipment. The contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within ten business days. If new equipment is to be installed the standard and acceptance of performance shall begin on the installation date. It shall end on the earlier date of when a certificate of acceptance has been signed or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification or as quoted in any contract at effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. Operational use time for performance testing for a system is defined as the accumulated time during which the equipment is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fine attempt to contact the contractor's designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes. 7. GOVERNMENT'S RESPONSIBILITY: The user will perform daily routine operator maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. 8. TRAINING OF OPERATING PERSONNEL: The contractor shall provide the services of a qualified technical person, at the time of new equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Technical Representative (COTR) to on-site orientation and training to designated personnel in: (1) operation and care of equipment; 2 techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause. 9. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: MAMC shall require the contractor to deliver the equipment ordered under this contract not later than SIXTY (60) calendar days after receipt of notice of award. a. Reagents Delivery terms, Quality of Reagents, Supplies and Disposables:: MAMC shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included, monthly from call orders of a MAMC representative. The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality slide product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO). b. Installation procedures: The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the installation may be suspended until such time as the cause of delay has been eliminated. The Contractor shall resumed the subject installation within 24 hours after the contractor has been notification. 10. MAINTENANCE: The contractor shall provide maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services. Preventive maintenance by contractor will provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment 11. TRAINING AND TECHNICAL SERVICE: The contractor, without additional charge to the government, shall provide training at a government location for two (2) operating personnel at the time of installation of the contractor's equipment. In addition, the contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. 12. SERVICE: Emergency repairs shall be performed within 24 hours after notification that the equipment is inoperative. The scheduled maintenance and service shall be performed by a qualified engineer with notice to the Contracting Officer Technical Representative (COTR). MAMC normal business hours are (6:00 am - 6:00 p.m., excluding weekends and holidays. Telephone response does not satisfy this requirement. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification. The contractor will provide all parts and labor needed to repair the malfunction. The travel, per diem and other expenses associated with the repair will be borne by the contractor. Otherwise, all services will be performed at no charge to the Government during this period. The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run. (END OF STATEMENT OF WORK) WRCO anticipates a Firm Fixed Price contract will be awarded. WRCO anticipates a base Period of Performance (POP) 1 October 2015 - 30 September 2016 with two 1-year option periods, ending 30 September 2017, if exercised. Information is being collected from all potential sources at this time. The Government will not answer any questions. Firms responding to this announcement should indicate whether they are a large business, small business, small disadvantaged business (SDB), woman-owned small business (WOSB), 8(a)-certified business, service-disabled veteran-owned small business (SDVOSB), veteran-owned small business (VOSB), or Historically Underutilized Business small business (HUBZone). The National American Industry Classification System (NAICS) code for this action is 339112, Surgical and Medical Instrument Manufacturing. All prospective contractors must be registered in the System for Award Management (SAM) database to be awarded a DoD contract. WRCO has not yet determined the acquisition strategy for this requirement, including whether a set-aside strategy is applicable. Note that a key factor in determining an acquisition to be a Small Business Set Aside is that small business prime contractors must perform over 50% of the effort, as defined in Federal Acquisition Regulation (FAR) clause 52.219-14. All interested parties shall submit a capabilities package. The capabilities package should be BRIEF and concise, yet clearly demonstrate an ability to meet the stated requirements. Recent, relevant experience in all areas should be provided, including whether this experience was as a prime or subprime contractor, whether it was in support of a Government or commercial contract, and what the scope of the experience was. Teaming and/or subcontracting arrangements should be clearly delineated and previous experience in teaming must be provided. Interested contractors will clearly explain how they intend to meet the stated requirements. Your statement of capabilities should include the following: Company Name; Address; Point of Contact; Telephone number; E-Mail Address; CAGE Code; Web Page URL; and Small business size certification, if applicable. Please submit one (1) electronic copy of your response to jose.d.domingo.civ@mail.mil. Statements should be submitted no later than Tuesday, 31 March 2015 at 12:00 (Noon) PM Pacific. The Government will not answer any questions. The Government will neither award a contract solely on the basis of this synopsis nor will it reimburse the contractor for any costs associated with preparing or submitting a response to this notice. This synopsis does not constitute a Request for Quotation (RFQ), Request for Proposal (RFP) or an Invitation for Bid (IFB), nor does this issuance restrict the Government's acquisition approach. The Government reserves the right to reject in whole or part any industry input as a result of this announcement. The Government recognizes that proprietary data may be a part of this effort. If so, clearly mark such restricted or proprietary data and present it as an addendum to the non-restricted/non-proprietary information.
- Web Link
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FBO.gov Permalink
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- Place of Performance
- Address: Western Regional Contracting Office ATTN: 673 Woodland Square Loop SE lacey WA
- Zip Code: 98503-1066
- Zip Code: 98503-1066
- Record
- SN03671358-W 20150320/150318234726-90a9984d0d9f3bd68f4570f326482776 (fbodaily.com)
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