66--NTX Polymedco Occult Blood Instrument

The North Texas VA Health Care System (NTXVHCS) is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB) or Small Business (SB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 13. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 325413. Any SDVOSB, VOSB or Small Business firms who wish to identify their interests and capability to provide this service must provide information by notifying the Contract Specialist no later than NOON PM Central Time August 15, 2018. Notification shall be e-mailed to Lula Hill, at contact@example.gov. DISCLAIMER This Source Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. SCOPE Statement of Work Cost Per Reportable Test Reagent Rental Agreement 1.Purpose Cost Per Reportable Test Reagent Rental Agreement for one Diana Occult Blood Testing Instrument. 2.Scope Vendor will provide one new Diana instrument with a cost-per-reportable-result (CPRR) agreement for the North Texas Veterans Health Care System, Pathology & Laboratory Medicine Service, which covers two new instruments, all reagents, supplies and services for the term that are included in the cost-per-reportable testing agreement. The agreement includes reagents, controls, calibrators, cuvettes, buffer, M-F 8-5pm service, consumables and maintenance parts, and other supplies needed. 3.Location These supplies will be used on the analyzers located in the Pathology and Laboratory Medicine Service s Dallas Laboratory at VANTHCS. 4.Performance Requirements: Maintenance: The Vendor 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 and on a scheduled time frame. 4.1.3 Test all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications. 4.1.4 After Preventative Maintenance (PM), the vendor shall submit a detailed work report to the COR for notice at no additional cost to the government. 4.1.5 Delivery of PM parts or material. The vendor shall provide all preventive service materials at no additional cost the government. 4.2. On-call Repairs: On-call repairs are emergency repairs beyond the scheduled maintenance. 4.2.1 The vendor shall provide technical assistance not limited to test performance, or equipment malfunction twenty-four (24) hours a day, seven (7) days a week, including all Federal and religious holidays, via direct communication thru a telephone bank with technically capacitated and certified personnel by the vendor. 4.2.2. The vendor shall respond to a call for on-site repair and be at the job site within two (2) hours during regular working hours, Monday Friday, 0800 16:00 hours. In very urgent cases, an immediate repair can be requested after 1600 hours and on Saturdays, Sundays and Federal holidays. After repair, the vendor shall submit a detailed work report to include all required materials and is to be at no-charge to the facility. 4.2.2.1 If the malfunction is reported to the vendor not later than 1600 hours, the failure elimination shall be started immediately on the same day. 4.3. For delivery of repairs parts or materials the vendor shall provide all parts and materials at no additional cost the government. 4.3.1 Vendor shall remove all parts, equipment or materials replaced, or upgraded by the vendor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the Government. 4.4 Safety 4.4.1 Vendor 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. 4.5 Test Performance 4.5.1 All test and procedures must comply and be approved by the FDA. 4.5.2. All test, procedures, and equipment must perform at manufacturer specifications, deviations from the performance specifications shall be corrected by the vendor. 4.5.3. All test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP peer evaluation according to CLIA 5.Period of Performance October 1,2018 through September 30,2019- Base Year October 1,2019 through September 30,2020- Option Year 1 October 1,2020 through September 30,2021- Option Year 2 October 1,2021 through September 30,2022- Option Year 3 October 1,2022 through September 30,2023- Option Year 4 Cost per Test Purchase Agreement will be in effect for 365-day period of a contract year, with options to extend. 6.Deliverables/Supplies This order is for reagents and supplies which will be purchased under the terms of the reagent rental purchase agreement. 6.1 The vendor shall provide on-site training for new personnel (as required) for testing and procedures of aforementioned, offer or shall conduct instructional course(s) to meet the objectives identified in paragraph 4. In addition, the vendor shall provide handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The vendor 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 vendor shall deliver all equipment and UPS necessary for test performance at no Government cost. 6.2.1 The vendor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications and test manuals. 6.3 The vendor shall install the equipment and perform test verification according to manufacturer specification, CLIA, FDA and CAP requirements. 6.4 The vendor shall provide supplies (FOBT latex, FOBT Calibrator, FOBT Controls, Wash Solution, Buffer, Curvettes, Calibrator Cups, and FOBT Mailers). 6.4.1 In the event that requested supplies are on back-order, vendor is to inform COR as to the estimated time of availability. 6.5 The vendor 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 vendor 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 or according to FDA guidelines. 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 vendor at no additional charge to the government. 7. Requirements 7.1 Instrument must consist of the following to meet the needs of the customer: Must be able to interface with VISTA (hospital s computer system) Must be a fully automated instrument that can perform >80 samples per hour. Must have closed sample testing device. Must have the ability to perform auto serial dilutions. Must have the ability to continuously load samples if needed. Must be no larger than 22 , 25 in width and a depth no greater than 22 Must be able to test samples using our current collection devices. 8.Contractor Security Contract Requirements. This vendor requires no access to VANTHCS or any VA information system. There will be supervised access when the vendor is physically present for technical support, service calls, and scheduled preventative maintenance. The instrument hard drive will remain on site for external repairs or termination of the lease. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. 9. Records Management All 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. 10. PERSONNEL QUALIFICATIONS: 101.1. The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this SOW. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. The work history of each contractor employee must contain experience directly related to the task and functions he/she is intended to perform under this contract. The Government reserves the right, during the life of the resulting contract, to request work histories on any contractor employee for the purposes of verifying compliance with the above requirements; additionally, the Government reserves the right to review resumes of contractor personnel proposed to be assigned. Personnel assigned to, or utilized by, the Contractor in performance of work shall be fully capable of performing the requirements contained in the PWS in an efficient, reliable, and professional manner. The normal manner of dress is business casual. 10.2. Specific Personnel Qualifications Requirements Personnel assigned to or utilized by the contractor in the performance of this contract shall, as a minimum: 10.2.1. Be qualified by the contractor as capable to perform as a field service representative. 11. PERFORMANCE STANDARDS AND QUALITY MEASUREMENT: 11.1 Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL). The Quality Assurance Surveillance Plan (QASP) method of surveillance will be by random inspection. 11.2 Performance Evaluation: After acceptance of the contract the system will be monitored for equipment performance including but not limited to; safety (recall Notifications and changes in reagents and equipment notifications), quality assurance (emergency repairs response, hot line troubleshooting response, quality of results compared to peer groups and CAP performance) and documentation (invoice accountability and invoice verification, equipment specification and user manuals), customer satisfaction (response to complaints and laboratory employees training) 11.Quality Assurance Surveillance Plan (QASP) and its performance are as follows: Task ID Indicator Standard Acceptable Quality Level Method of Surveillance Incentive Deliverables 4.1.2 Reagents Prompt delivery of reagents and written notification of back orders or allocations of reagents. 100% Monthly monitoring Exercise of Option Period and past performance Safety 4.4.1 Recall Notification Immediately recall notification of reagent and supplies. 100% Monthly monitoring Exercise of Option Period and past performance. 4.4.1 Changes in reagent and equipment modifications. Timely distribution / notification of changes in reagents and equipment modifications 100% Direct Observation Exercise of Option Period and past performance. Quality Assurance 4.2.2.1 Emergency Repairs Within 24 hours <2 Repairs by quarter by equipment. 95% Monthly monitoring Exercise of Option Period and past performance. 4.2.1 Trouble-shooting via phone. Within 24 hours 95% Monthly Monitoring Exercise of Option Period and past performance. 4.5.2 Successful reporting of results Repeat runs are minimal 95% Direct Observation, Quality control reports run as needed. Exercise of Option Period and past performance. 4.5.3 Successful Peer group comparison CAP survey performance 95% Direct Observation CAP survey report Exercise of Option Period and past performance. Documentation 6.5 Invoice Accountability Monthly invoices 100% Invoices received through OLCS via Austin, Texas Exercise of Option Period and past performance. 6.5.1 Invoice Verification Monthly invoices 100% Invoices contain all necessary information for proper processing. Exercise of Option Period and past performance 6.2.1 Equipment specifications and user manuals Provided prior to delivery of equipment. 100% Up to date information supplied by vendor as changed. Exercise of Option Period and past performance Customer Satisfaction 11.2 Substantiated complaints from lab users 1 complaint per quarter 100% Reports of contacts or other documentation. Exercise of Option Period and past performance 6.1 Training of laboratory personnel Provided upon activation of new system. 100% Reports of contacts or other documentation. Exercise of Option Period and past performance NARA 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, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 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, dispose of, 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 or authorized 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 contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. 5. Contractor shall not create or maintain any records containing any Government Agency records 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 this contract. 7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation 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 Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. 9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 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 disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. References: VHA Directive 6300 VA Handbook 6300.1 North Texas VA Medical Center Policy VA Directive 6500 36 CFR Part 1222.32 (b)