Q--Rental for DX eSensor XT8 system with HCVgenome Tests

THIS IS A SOURCES SOUGHT NOTICE. This is not a request for proposals. A solicitation will not be issued at this time. The Department of Veterans Affairs, North Texas VA Health Care System (NTXVHCS) at 4500 S. Lancaster Rd, Dallas, Tx 75216 has a requirement for procurement of reagents and lease the equipment for a DX eSensor XT8 System and HCVgenome tests The intent of the procurement is to award a base plus 4 option years contract. The applicable NAICS code is 334516- Analytical Laboratory Instrument Manufacturing. Small Business manufacturers for this NAICS code have a size standard of 1,250 employees. The resulting contract will be a base plus 4 option years, firm fixed price contract. The period of performance shall begin no later than 10/01/2018 and shall be active through 9/30/2023.This notice is published to conduct market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses

(VOSB), or Small Businesses (SB), capable of performing the requirements to warrant a socio-economic set-aside. It is strongly recommended that interested parties register in the US Department of Veterans Affairs Vet Biz database and the Small Business Administration (SBA) database. Registration may be accomplished at http://www.vip.vetbiz.gov/ and www.sba.gov/, respectively. Interested parties responding to this sources sought request shall submit the following information at a minimum: (1) company name and address, point of contact with phone number, and DUNS number; (2) documentation relating to capability of performance (including references); (3) intentions of subcontracting program to include set-asides; (4) proof of registration in the VA Vet Biz or SBA websites or intention of registration prior to submission of offers to a solicitation; (5) documentation on company s bonding capacity and limitations; and (6) any other pertinent company documentation. The response date to this Sources Sought notice is August 23, 2018 at 9am ET time. This market research is for informational and planning purposes only to determine if a socio-economic set-aside, or sole-source procurement is appropriate. The Government will not pay any costs for responses submitted. Electronic submissions are acceptable directly via eBuy and copy Grace.Barr@va.gov. NO ADDITIONAL INFORMATION IS AVAILABLE OTHER THAN WHAT IS NOTED HEREIN. Statement of Work for Reagent Rental Purchase Agreement for the Dx maintenance free electrochemical detection platform (eSensor XT8) Complete System, Laboratory Reagents, and Supplies for Performing the Hepatitis C Genotyping Direct Assay PurposeVA North Texas Health Care System is requesting a maintenance free electrochemical detection platform (DX eSensor XT8) System and HCVg tests through reagent rental purchase agreement. The vendor s Cost-per-Test Pricing Proposal will be based on estimated workload volumes of 1200 Hepatitis C Genotyping Direct tests per year for a base plus 4 Option year agreement.ScopeThe contractor will provide the eSensor XT8 System analyzer, two (2) analyzer modules, printer pack, and accessory kit. The contractor may be required to install additional modules based on workload volumes and result turn-around-times. Any additional towers/ instruments will be be contracted by an addendum. The contractor will provide onsite instrument installation and start-up, on-site instrument test validation, technical support and guidance, and on-site training for testing personnel. The eSensor XT8 is a random access analyzer capable of processing up to 24 tests simultaneously and requires no routine maintenance or instrument calibration. The eSensor HCVg (genotype) Direct Test is designed to genotype a panel of eight (8) prevalent HCV type/subtypes (1a, 1b, 2a/c, 2b, 3, 4, 5 and 6), using a multiplex RT (reverse transcriptase) PCR amplification of extracted nucleic acid followed by a direct analysis on the electrochemical eSensor XT-8 detection system. The system utilizes a proprietary eSensor technology where the target DNA is mixed with the signal probe solution in the cartridge and analyzed via solid-phase electrochemical method using voltammetry to detect specific signal generated by the hybridization of ferrocene-labeled signal probes. The cartridge is pre-programmed with the test protocol, lot number, and expiration date on an internal memory chip to minimize errors. Testing should require minimal training time. Extracted sample set-up time is seven (7) minutes, and 40 minutes total tech hands on time. Test results are available in 4.5 hours. All reporting is automatic and consists of all relevant types and subtypes. No manual reading is required. Automated (interfaced) reporting eliminates the need for manual interpretation and manual data entry and the incidence of interpretation errors. The XT-8 can be interfaced with lab systems through Data Innovations (DI). Technical support is available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries. On-site technical support is available for escalations within 48 hours. In cases where issues with the modules cannot be resolved over the phone, the contractor will exchange the module with a new unit. Technical support will analyze the reported issue and will make a final decision for module (or tower) replacement. The contractor will ship the exchange module the next business day (if reported before 2pm CST) to arrive within 48 hours. The failed module will be shipped back to contractor. The contractor will pay all shipping costs for return of the failed module and shipping costs for the exchanged module. Pathology & Laboratory Medicine Service (P&LMS) at the Dallas VA North Texas Health Care System (VANTHCS) will order reagents and supplies from contractor, Inc. as needed to perform Hepatitis C genotyping Direct testing on the Dx eSensor XT8 analyzer, which will be located in the P&LMS, Dallas VANTHCS. LocationThe Dx eSensor XT8 analyzer will be located and testing will be performed in the Molecular Diagnostics Laboratory of P&LMS, Dallas VANTHCS. Performance RequirementsMaintenance: The Contractor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:4.1.1 Inventory and recording of systems components. 4.1.2 Monthly deliverables shall be received in full. 4.1.3 Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications.4.1.4 After Preventative Maintenance (PM), the contractor shall submit a detailed work report for notice at no additional cost to the government.4.1.5 Delivery of PM parts or materials: The contractor shall provide all preventive service materials at no additional cost the government.4.2. Repairs and Support.4.2.1 Technical Support: Support Personnel will be available by telephone from 8:00 a.m. to 5:00 p.m. Pacific Standard Time each business day, and live representatives at via the contractor s message center will be available by telephone at all other times. 4.2.2.1 On-site Repairs: With respect to any technical support issue that the contractor determines to require on-site support at the Customer s facility, GenMark will dispatch one or more Support Personnel to such facility, normally within 48 business hours after GenMark has logged the corresponding Customer Support Contact s technical support call to GenMark. Any such on-site technical support will be provided between the hours of 8:00 a.m. to 5:00 p.m., Customer s local time, on a business day. After repair, the contractor shall submit a detailed work report to include all required materials and is to be at no-charge to the facility.4.2.2.2 If a problem cannot be resolved over the phone an exchange of instruments will take place. The exchange instrument will shipped the next business day and will be scheduled to arrive within 48 hours. The exchange instrument will be unpacked on site. The instrument that failed will be packaged in the container the exchange instrument came and shipped back to GenMark Diagnostics. GenMark Diagnostics will provide a prepaid means of shipping the failed instrument back to them. 4.3. For the delivery of repairs parts or materials the contractor shall provide all parts and materials at no additional cost the government.4.3.1 Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government.4.4 Training: The contractor will provide up to three (3) consecutive days of on-site operator training on request for any new assays or reagents introduced to the eSensor XT8 System analyzer. On-site training and will be provided between the hours of 8:00 a.m. to 5:00 p.m., Central Time, on business days only.4.4.1 Validations: The contractor will provide initial installation and validation of the system at no cost, including up to 4 HCVG RUO kits (96 tests). Contractor will, on request, provide on-site training for new personnel and validation assistance with any new assay or reagent introduced to the system.4.5 Safety 4.5.1 Contractor shall immediately notify the service of any changes in reagents kits composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulations.4.6 Test Performance4.6.1 All test, procedures, and equipment must perform at manufacturer specifications; deviations from the performance specifications shall be corrected by the contractor.4.6.3. All test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP peer evaluation.Period of PerformanceCost per Test Purchase Agreement for the GenMark Dx eSensor XT8 analyzer will be in effect for 365-day period of a contract year, with options to extend contract for a total of 5 years. Contractor shall provide option to upgrade to newer version of instrument, if available, in option years.Base period - October 1, 2018 through September 30, 2019Option year 1 - October 1, 2019 through September 30, 2020Option year 2 - October 1, 2020 through September 30, 2021Option year 3- October 1, 2021 through September 30, 2022Option year 4- October 1, 2022 through September 30, 2023Deliverables/SuppliesThis order is for the cost per test procurement of the GenMark Dx eSensor XT8 analyzer. Reagents and supplies will be purchased under the terms of the reagent rental purchase agreement.6.1 The contractor shall provide on-site training for new personnel (as required) for testing and procedures of aforementioned and shall conduct instructional course(s) to meet the objectives identified in paragraph 4. In addition, the contractor shall provide handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The contractor shall provide lesson plan, course materials and media (DVD s, CD s, videos, etc. if required) for each procedure at no additional cost.6.2 The contractor shall deliver all equipment and UPS necessary for test performance at no Government cost.6.2.1 The contractor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications and test manuals. 6.3 The contractor shall install the equipment and perform test verification according to manufacturer specification and CAP requirements.6.4 The contractor shall provide equipment: kits for the Hepatitis C Genotyping Direct assay.6.4.1 In the event that requested supplies are on back-order, contractor is to provide information as to the estimated time of availability. 6.5 The contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle. 6.5.1 All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost.6.6 Remedies:6.6.1 Any changes in reagents or equipment modifications shall be immediately disclosed by the contractor electronically as well as by postal mail with supporting documentation of the change and, detailed guidance against implementation within twenty four hours of its application.6.6.2 Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to out sourcing, transportation and or any other additional cost shall be covered by the contractor at no additional charge to the government. Salient Characters7.1 Instrument must consist of the following to meet the needs of the customer:Is random accessHas a total time to result of 4.5 hoursRequires less than 10 minutes total hands on load time per specimen and less than 45 minutes total hands on timeAutomatically reads and provides genotype no interpretation required. Can be interfaced with VistA Is able to detect the following subtypes: 1a, 1b, 2a/c, 2b, 3, 4, 5 and 6Is a bench top instrument with a footprint no larger than 20" x 16" x 16.5"Is capable of testing up to 24 specimensNo routine maintenance or calibrations requiredAbility to add additional tests to the platform: CYP450 2C9 (*2 and *3), Factor V (Leiden), MTHFR 677 and 1298Capable of testing multiple assays simultaneouslyDoes not use the following software: Windows XP Embedded Service Pack 3, Windows Server 2003 or Windows XPCompany has the ability to provide an upgraded analyzer if needed when testing volume increases (subject to addendum)Contractor Security Contract Requirements.This contractor requires no access to VANTHCS or any VA information system. The GenMark Dx eSensor XT8 analyzer will be interfaced to the VANTHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.Records ManagementAll records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.Quality Assurance Surveillance Plan (QASP) and its performance are as follows:Scoring Average score value per category: Exceptional 4Very Good 3Satisfactory 2Marginal 1Unsatisfactory 1StandardTaskID(CPARS)IndicatorAcceptable Quality LevelMethod of Surveillance Incentive Repeat runs are minimal due to reagent or instrument issues.1.1Successful reporting of resultsNo more than 2 instances of repeat runs due to a single reagent or instrument issue per quarter.Exceptional: 0Very Good: 1Satisfactory: 2Marginal: 3Unsatisfactory: >3Troubleshooting recordsService recordsExercise of Option PeriodMinimal unsuccessful performance due to instrument or reagent issues.1.2Successful peer group comparison90% satisfactory performance to peer group.Exceptional: 100%Very Good: 95-99%Satisfactory: 90-94%Marginal: 85-89%Unsatisfactory: 85%CAP survey reportsExercise of Option PeriodInstrument downtime is minimal.1.3Instrument Repairs90% satisfactory instrument performance annually.Exceptional: 100%Very Good: 95-99%Satisfactory: 90-94%Marginal: 85-89%Unsatisfactory: 85%Troubleshooting recordsService RecordsSendout recordsTAT reportsEngineer visit within 48 hours of service designation. Schedules2.1Emergency Repairs90% Visits within 48 hours of service designation.Exceptional: 100%Very Good: 95-99%Satisfactory: 90-94%Marginal: 85-89%Unsatisfactory: 85%Troubleshooting recordsService recordsExercise of Option PeriodVendor initiates scheduling of preventive maintenance.2.2Proactive Maintenance Service95% Visits initiated by vendor.Exceptional: 100%Very Good: 98-99%Satisfactory: 95-97%Marginal: 85-89%Unsatisfactory: 85%Service recordsProblem recordsTelephone Support is responsive. 2.3Trouble-shooting via phone95% Issues resolved within 3 calls or elevated to service.Exceptional: 100%Very Good: 98-99%Satisfactory: 95-97%Marginal: 85-89%Unsatisfactory: 85%Troubleshooting recordsProblem recordsService recordsExercise of Option PeriodInvoices are submitted monthly.Cost Control3.1Invoice Accountability100% Invoices received through OLCS via Austin, Texas Invoice recordsExercise of Option PeriodInvoices are itemized by service or product received.3.2Invoice Verification80% Invoices contain all necessary information for proper processing.Excellent: 95-100%Very Good: 90-94%Satisfactory: 85-89%Marginal: 80-84%Unsatisfactory: 80%Invoice recordsExercise of Option PeriodBackordered reagents and supplies are minimal.Management4.1Backorders5% Backorders per year.Excellent: 0%Very Good: 1-2%Satisfactory: 3-4%Marginal: 5%Unsatisfactory: >5%Order recordsInvoice recordsCustomer communicationsExercise of Option PeriodProvides timely follow-up for backorders.Regulatory6.1Backorder Notification90% timely follow up for backordersExceptional: 100%Very Good: 95-99%Satisfactory: 90-94%Marginal: 85-89%Unsatisfactory: 85%Order recordsInvoice recordsCustomer communicationsExercise of Option PeriodContractor will provide proactive notification of changes.6.2Notification of changes in reagent and equipment modifications100% Proactive notifications.Quality BulletinsCustomer LettersCustomer ContactExercise of Option PeriodTimely recall notification of reagent and supplies.6.3Recall Notification 100% Recall notifications within 1 month of issuance. Quality BulletinsCustomer LettersCustomer ContactExercise of Option PeriodWorks with customer to resolve complaints.Customer Satisfaction7.1Substantiated complaints No unresolved substantiated customer complaints per yearOrder recordsInvoice recordsCustomer communicationsProblem recordsTroubleshooting recordsExercise of Option PeriodTimely follow-up on complaints.7.2Complaint Handling90% Complaint follow-up within 24 hours of initial complaint or within agreed upon timeframe.Exceptional: 100%Very Good: 95-99%Satisfactory: 90-94%Marginal: 85-89%Unsatisfactory: 85%Order recordsInvoice recordsCustomer communicationsProblem recordsTroubleshooting recordsExercise of Option PeriodNARA RM Language Clause to be included in contracts, as necessary:1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFRPart 1222 and Part 1228.2. Contractor shall treat all deliverables under the contract as the property of the U.S.Government for which the Government Agency shall have unlimited rights to use, disposeof, or disclose such data contained therein as it determines to be in the public interest.3. Contractor shall not create or maintain any records that are not specifically tied to orauthorized by the contract using Government IT equipment and/or Government records.4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that containsinformation covered by the Privacy Act of 1974 or that which is generally protected by theFreedom of Information Act.5. Contractor shall not create or maintain any records containing any Government Agencyrecords that are not specifically tied to or authorized by the contract or identified in the RCS 10-1.6. The Government Agency owns the rights to all data/records produced as part of thiscontract.7. The Government Agency owns the rights to all electronic information (electronic data,electronic information systems, electronic databases, etc.) and all supportingdocumentation created as part of this contract. Contractor must deliver sufficient technicaldocumentation with all data deliverables to permit the agency to use the data.8. Contractor agrees to comply with Federal and Agency records management policies,including those policies associated with the safeguarding of records covered by the PrivacyAct of 1974. These policies include the preservation of all records created or receivedregardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] orstate of completion [draft, final, etc.].9. No disposition of documents will be allowed without the prior written consent of theContracting Officer. The Agency and its contractors are responsible for preventing thealienation or unauthorized destruction of records, including all forms of mutilation. Willfuland unlawful destruction, damage or alienation of Federal records is subject to the finesand penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legalcustody of the Agency or destroyed without regard to the provisions of the agency recordsschedules.10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosureof information, documentary material and/or records generated under or relating to thiscontract. The Contractor (and any sub-contractor) is required to abide by Government andAgency guidance for protecting sensitive and proprietary information.References: VHA Directive 6300VA Handbook 6300.1North Texas VA Medical Center PolicyVA Directive 6500 36 CFR Part 1222.32 (b) Contact Information: Grace BarrGrace.Barr@VA.Govgrace.barr@va.gov Office Address :Department of Veterans Affairs;NCO 17 North Texas Healthcare System;NCO 17 Network Contracting Activity;4500 S. Lancaster Road;Dallas TX 75216 Location: Department of Veterans Affairs No. Texas Health Care System Set Aside: N/A