6550--VISN 8 RT-PCR Micro-Molecular Analyzer System & Reagent test
STATEMENT OF WORK 1. GENERAL: The Contractor shall provide new equipment reagent rental, cost-per-test (CPT) Real-Time Polymerase Chain Reaction (RT-PCR) analyzer systems, reagents, supplies, and cons... STATEMENT OF WORK 1. GENERAL: The Contractor shall provide new equipment reagent rental, cost-per-test (CPT) Real-Time Polymerase Chain Reaction (RT-PCR) analyzer systems, reagents, supplies, and consumables capable of performing Food and Drug Administration (FDA) approved or Emergency-Use-Authorization (EUA) approved patient testing. Testing assays and patient specimen types to include SARS-CoV-2 (COV2), Influenza A, B, and Respiratory Syncytial Virus (FLU/RSV), and Methicillin-resistant-Staphylococcus-aureus (MRSA) detection from nasal/nasopharyngeal swabs; Detection of Mycobacterium tuberculosis resistance to Rifampin (MTB/RIF) from sputum; Clostridium difficile (CDIFF) and Norovirus (NOV) detection from stool; Carbapenem Resistance (CARBA-R) detection from rectal swabs; BCR-ABL (BCR-ABL) gene mutation, Factor II (FII)/Factor V Leiden (FV) gene mutation detection from whole blood, MVP, and Chlamydia & Gonorrhea (CT/NG) from female and male urine, vaginal swabs, endocervical swabs, and female and male pharyngeal and rectal swabs; and any other RT-PCR testing deemed medically necessary by Tampa VAMC Micro/AFB and Molecular Departments, Tampa, Florida, Tampa VAMC Mental Health Clinic, Tampa Florida, New Port Richey (NPR) VA Laboratory, New Port Richey, Florida, Miami VAMC, Miami Florida, West Palm Beach VAMC, West Palm Beach, FL Pathology & Laboratory Medicine Service care-providers. The requirement is for JAH VAMC, Miami VAMC, and West Palm Beach VAMC Pathology & Laboratory Medicine Services. This requirement may include future JAH VAMC CBOC laboratory testing facilities as deemed necessary by VA care providers. 2. BACKGROUND: The Tampa VAMC, Miami VAMC, and West Palm Beach VAMC Pathology & Laboratory Medicine Services have a requirement for an FDA-approved, automated RT-PCR diagnostic systems including vendor provided equipment, FDA-approved / EUA-approved (FDA/EUA-approved) reagents, supplies, and consumables for RT-PCR testing to provide care for our VA patient population. 3. PURPOSE: The ability to perform RT-PCR testing using FDA-approved automated analyzer systems utilizing FDA/EUA-approved reagents, supplies and consumables to provide care for our VA patient population. 4. SCOPE: Tampa VAMC, Miami VAMC, and West Palm Beach VAMC are requesting contractor s new equipment that meets all the minimum physical, functional and performance features of the listed salient characteristics in this statement of need. The salient characteristics are essential to the technical requirements to meet the needs of the government. Hardware and software will meet all VA Technical Reference Manual (TRM) requirements prior to requesting connection to the VA Network. 5. EQUIPMENT: Contractor shall provide FDA-approved, new fully automated, and integrated analyzer testing systems, printers, computers, uninterruptable power supplies (UPS) for all analyzers, and accessories required for equipment usage. Below are the salient characteristics of the Food and Drug Administration (FDA) approved or Emergency-Use-Authorization (EUA) approved patient testing. Testing assays and patient specimen types to include SARS-CoV-2 (COV2), Influenza A, B, and Respiratory Syncytial Virus (FLU/RSV), and Methicillin-resistant-Staphylococcus-aureus (MRSA) detection from nasal/nasopharyngeal swabs; Detection of Mycobacterium tuberculosis resistance to Rifampin (MTB/RIF) from sputum; Clostridium difficile (CDIFF) and Norovirus (NOV) detection from stool; Carbapenem Resistance (CARBA-R) detection from rectal swabs; BCR-ABL (BCR-ABL) gene mutation, Factor II (FII)/Factor V Leiden (FV) gene mutation detection from whole blood, MVP, and Chlamydia & Gonorrhea (CT/NG) from female and male urine, vaginal swabs, endocervical swabs, and female and male pharyngeal and rectal swabs with specific functionality and performance-based requirements of the system. The proposal shall provide descriptive literature that meets the following specifications for the testing systems and assay requirements: General instrument characteristics include ability to run Food and Drug Administration (FDA) approved or Emergency-Use-Authorization (EUA) approved patient testing. Testing assays and patient specimen types to include SARS-CoV-2 (COV2), Influenza A, B, and Respiratory Syncytial Virus (FLU/RSV), and Methicillin-resistant-Staphylococcus-aureus (MRSA) detection from nasal/nasopharyngeal swabs; Detection of Mycobacterium tuberculosis resistance to Rifampin (MTB/RIF) from sputum; Clostridium difficile (CDIFF) and Norovirus (NOV) detection from stool; Carbapenem Resistance (CARBA-R) detection from rectal swabs; BCR-ABL (BCR-ABL) gene mutation, Factor II (FII)/Factor V Leiden (FV) gene mutation detection from whole blood, MVP, and Chlamydia & Gonorrhea (CT/NG) from female and male urine, vaginal swabs, endocervical swabs, and female and male pharyngeal and rectal swabs on RT-PCR technology-based platforms. RT-PCR Annual Estimated Test Volumes: Note: The total for all three locations. Fully automated, integrated, random access RT-PCR testing system. Nasopharyngeal sample collection kits for COV2, FLU/RSV and MRSA testing. EUA-approved COV2 testing on asymptomatic patient samples. Self-contained, closed-cartridge test assays. 90-minute detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) Analyzer system that provides high throughput: handling approximately 40 RT-PCR tests in 2 hours capable of detecting at least 1 to 24 patients simultaneously. Analyzer system that provides 6-color excitation and detection modules for multiplexing, providing thermal and optical data in real time which increases the number of targets and controls available in test design and implementation. BCR-ABL gene fusion assay that detects transcript types e13a2 and/or e14a2 to monitor therapy for patients diagnosed with Chronic Myelogenous Leukemia (CML). Factor II and Factor V assay that detects allele mutations to aid in the diagnosis of suspected thrombophilia. Bar-coded sample entry capabilities. Ability to run multiple assay protocols simultaneously. User-friendly software that provides access to amplification curves within runs. Ability to display/print all internal QC. An Internal Control/Quantitation Standard (IC/QS) must be incorporated into each individual sample and carried through the sample preparation, testing and result phases of analysis for each assay. Contractor shall provide all necessary software and hardware for the systems valid, acceptable, bidirectional interface data transmission through Data Innovation (DI) Instrument Manager (IM) middleware network connections. Contractor shall provide all necessary system interface hardware and software upgrades as required for VA network compliance. Shall provide supporting documentation required to maintain or improve level of data retrieval, which may be used for epidemiology measures. Contractor shall provide all upgrades to the equipment hardware and operating system software, all-inclusive with established cost. Operator and Service Manual shall be furnished with each model supplied. Electronic formats are acceptable. Procedures shall be provided in accordance with the Clinical and Laboratory Standards Institute (CLSI) in editable format. Contractor to provide all test kits, reagents, supplies, and consumables, as well as Contractor assistance for instrument and method validations. Additional testing and/or testing locations may be added in support of patient care needs as determined by VA care providers. Computer systems (CPUs, Monitors, Keyboards, Printers), and UPSs provided by Contractor for all instruments throughout contract period. Our laboratory working space dimensions in inches ( ) are listed below. Contractor to offer analyzer systems that fit within spaces listed below which includes working space: Instrument Space Requirements: Tampa VAMC Micro: 105 Width x 80 Height x 70 Depth. AFB: 36 Width x 24 Height x 29 Depth. Molecular: 48 Width x 28 Height x 28 Depth. NPR Lab: 36 Width x 24 Height x 29 Depth. Mental Health Clinic: 36 Width x 24 Height x 29 Depth. Electrical Characteristics: Micro: 200 to 240VAC, 50/60Hz, 20A. AFB: 1.9 A at 100 V, 0.95 A at 200 V. Molecular: 8.24 A at 100 V, 4.12 A at 200 V. NPR Lab: 1.9 A at 100 V, 0.95 A at 200 V. Mental Health Clinic: 1.9 A at 100 V, 0.95 A at 200 V. Miami VAMC Micro: 105 Width x 80 Height x 70 Depth. Electrical Characteristics: Micro: 200 to 240VAC, 50/60Hz, 20A. WPB VAMC i Micro: 200 to 240VAC, 50/60Hz, 20A. ii. 8.24 A at 100 V, 4.12 A at 200 V. Electrical Characteristics: Micro: 200 to 240VAC, 50/60Hz, 20A. 8.24 A at 100 V, 4.12 A at 200 V. 6. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to requirements of the system: Preventive Maintenance shall be performed per manufacturer s guidelines. Instrument service to be provided 24 hours per day, 7 days per week including holidays. Expected response to service call time from initial call to Contractor to service engineer arriving on site should be no more than 24 hours including weekdays, weekends, and holidays. 24/7 Technical Support Hotline must be available for in-house troubleshooting. The Cost per-test includes costs covering (a) new FDA-approved instrument systems (lease), (b) equipment use, computers, printers and accessories including Uninterruptable Power Supplies for all instruments (UPS), (c) Software and hardware, (d) all aspects of computer interfacing for all analyzer systems, (e) reagents offered by vendor, (f) all necessary supplies and consumables, (g) all necessary service, maintenance and parts to keep the equipment in good operating condition to fulfill the test requirements and produce high quality patient results, (h) operational hardware and software upgrades, (i) user training for government personnel, and (j) upon expiration of order(s) and/or termination and/or replacement of equipment, will provide equipment decontamination, turn-in hard drives with VA sensitive information to VA IT Department, and return packing and shipping at no additional charge. 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, EUA, and manufacturer s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein. The contractor will provide analyzers or testing systems, parts and 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. Discontinued or refurbished analyzers or testing system models are not acceptable. All models shall perform satisfactorily at any laboratory temperature between 59- and 86-degrees F (15 and 30 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity of 10 to 70%. An electronic operator s manual must be furnished with each model supplied. 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 manufacturers 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 and 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 decontaminate and remove the equipment and turn in any hard drives containing VA sensitive information to VA IT Department. The contractor will disconnect the equipment and will be responsible for all decontamination, packing, shipping, and charges required to remove the equipment within ten business days. With all new equipment, 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 equipment installation and at such time designated by Contracting Officer's Representative (COR) for on-site orientation and training for 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. Off-site training to be provided at no additional cost to the VA, if available, for 2 designated personnel initially and 2 additional training slots per year for each subsequent contract year. 9. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: Reagents Delivery terms, Quality of Reagents, Supplies and Consumables: The VA shall require the delivery of reagents, supplies and consumables for all services required under this contract. The contractor shall deliver reagents, supplies and consumables, shipping cost included, from monthly call orders placed by JAH VAMC, West Palm Beach VAMC, and Miami VAMC representatives. The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce high-quality, accurate patient results. The FDA-approved reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC). 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 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 resume the subject installation within 24 hours after the contractor has been notified. 10. MAINTENANCE: The contractor shall provide maintenance (labor, parts, and shipping) 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. 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 Representative (COR). JAH VAMC, Miami VAMC, and West Palm Beach VAMC is open 24 hours a day, 7 days a week including 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, labor and shipping 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. 12. TECHINCAL UPGRADES: 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. 13. WARRANTY OF EQUIPMENT: Government requirement for standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment. 14. DELIVERY SCHEDULE: All equipment to be delivered within 60 days after Receipt of Order (ARO) processing and placement. Any required initial equipment staging, setup, installation, correlation, and transition, to be completed within six (6) months ARO processing and placement. All reagents, consumables, supplies, to be delivered within ten (10) days ARO processing and placement. 15. PLACE OF DELIVERY: Warehousing Department located at: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612. New Port Richey VA Outpatient Clinic, 7900 Little Rd, Ste 1PA100, New Port Richey, FL 34654. VA Mental Health Outpatient Clinic, 8501 Temple Terrace Highway Tampa, FL, 33637. Bruce W. Carter VA Medical Center, 1201 NW 16th St, Miami, FL 33125. West Palm Beach VA Medical Center, 7305 N Military Trail, West Palm Beach, FL 33410. 16. NARA RECORDS MANAGEMENT LANGUAGE: 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. Tampa VAMC, Miami VAMC, and West Palm Beach VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Tampa VAMC, Miami VAMC, and West Palm Beach VAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to JAH VAMC, Miami VAMC, and West Palm Beach VAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Tampa VAMC, Miami VAMC, and West Palm Beach VAMC s control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6. The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Tampa VAMC, Miami VAMC, and West Palm Beach VAMC guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Tampa VAMC, Miami VAMC, or West Palm Beach VAMC VAMC s policy. 8. The Contractor shall not create or maintain any records containing any non-public Tampa VAMC, Miami VAMC, or West Palm Beach VAMC information that are not specifically tied to or authorized by the contract. 9. The 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 from public disclosure by an exemption to the Freedom of Information Act. 10. The Tampa VAMC, Miami VAMC, or West Palm Beach VAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Tampa VAMC, Miami VAMC, and West Palm Beach VAMC shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #4192704, Records Management for Everyone. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] Flowdown of requirements to Subcontractors (if applicable): 1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. 2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.
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