S02.GNV Multiple Site SOW FY2023 Attachment.docx

Statement of Work

NF/SG VAMC

Molecular Microbiology Testing Cost per Test

I. Introduction North Florida/South Georgia requires a Cost Per Test (Reagent Rental) Award for Real Time PCR analyzers and reagents for the Microbiology / Molecular Diagnostics for the NF/SG VAMC and VAOPCs, a total of 5 sites. The equipment must be capable of detecting MRSA from Nasal Swabs, MTB/RIF from respiratory samples, C. difficile/Epi gene from stool samples, Carba-R from direct colony or rectal swabs, SARS-CoV2, Influenza A, B, RSV, BCR/ABL, MRSA/SA from blood culture bottles, Trichomonas vaginalis (TV) from male urine, Chlamydia trachomatis and Neisseria gonorrhea from vaginal/cervical/urine samples, and Streptococcus grp A from throats.

The Contractor shall provide all sites in Pathology & Laboratory Medicine Service for Department of Veterans Affairs (DVA), North Florida / South Georgia Veterans Health System (NF/SG VHS) laboratories performing tests according to the test menu provided. The vendor(s) selected is responsible for equipment and service components specific to each facility and are fixed monthly expenses. Each facility shall pay for the level of equipment and/or service it requires.

The Contractor in accordance with the terms and conditions stated herein to furnish to and/or at the following NF/SG VHS Sites: Gainesville VAMC, 1601 SW Archer Rd., Gainesville, FL 32608; Lake City VAMC, 619 S. Marion Ave., Lake City FL. 32025; Jacksonville OPC, 1536 N. Jefferson, FL. 32206; Tallahassee OPC, 1607 St. James Ct., Tallahassee, FL. 32308; and The Villages OPC, 8900 SE 165th Mulberry Ln., The Villages, FL. 32162the supplies at the prices specified in Schedule of Services and Prices of this contract. The initial listing of supplies to be furnished is identified in the Schedule of Services and Prices, and Statement of Work.

A. Scope of Work

1. General: The award for Cost per Test will be based off of the Request for Quote (RFQ). The offeror shall provide to NF/SG VHS laboratories, all supplies and services. CPT shall also include service of all equipment for the life of the agreement as identified below.

The NF/SG is seeking an agreement which includes a) equipment rental, b) reagents and controls, c) service and necessary maintenance & parts to keep the equipment in optimal operating conditions, d) operational hardware and software upgrade/updates, e) user training for government personnel, f) reagents’ delivery costs, g) consumables for the lifetime of the contract. Contractor is required to provide delivery and installation of equipment, as well as equipment return at end of contract, at no additional charge.

2. Cost per Test: CPT is an all-inclusive price based on a minimum of disposables per month. The contractor is required to furnish all supplies necessary to operate the contractor’s equipment for the testing menu as defined, including reagents and supplies to operate the instruments and all repairs and two preventive maintenance visit per system per year.

3. Additional Fixed Cost Disclosure: All pieces of equipment required for system operation as requested, including but not limited to: Instruments, service agreements and maintenance of all equipment, hardware and software including all installation costs, service, maintenance and future software upgrades are to be separated into an initially defined total cost disclosure for the contract period. CPT shall note test cost plus additional defined fixed costs per test/ surcharge. Increase in test volume shall not incur increase in additional fixed costs unless new equipment has been added in addition to the current provided services.

4. Term of Local Purchase Agreement: The contract term is for a 12 month base, with four options of 12 months. NF/SG VAMC will issue a delivery order only for the current FISCAL year. The VA’s obligation under this contract shall terminate at the end of each fiscal year. NF/SG VHS may renew by exercising the option to extend the term of the contract that shall be effective the first day of each succeeding fiscal year.

5. Support Services: Vendor shall provide telephone assistance 24-hours/day, 7 days/week 365 days per year. Following determination that service is required, technical on – site support must be provided under the terms of the Federal Supply Schedule and provide for emergency repairs seven days per week within twenty-four (24) hours of the time of notification of the malfunction. The contractor shall provide maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government will provide the contractor access to the equipment to perform maintenance service according to the maintenance and service terms below.

6. Testing Menu: Vendor shall provide the test menu as defined in Attachment A. Annual test volumes provided with this contract are based upon the required minimum. Specimen integrity checks shall be made on all specimens at no additional charge. The vendor will notify the contractor when there is a change in supplies.

7. DVA, NF/SG VHS TEST MENU / VOLUMES. Total tests per year are estimated based on the volumes per month.

II. Equipment Requirements/Capabilities The equipment must be capable of detecting MRSA from Nasal Swabs, MTB/RIF from respiratory samples, C. difficile/Epi gene from stool samples, Carba-R from direct colony or rectal swabs, SARS-CoV2, Influenza A, B, RSV, BCR/ABL, MRSA/SA from blood culture bottles, Trichomonas vaginalis (TV) from male urine, Chlamydia trachomatis and Neisseria gonorrhea from vaginal/cervical/urine samples, and Streptococcus grp A from throats. The purpose of this solicitation is to identify the salient characteristics of Real Time PCR instrument(s) capable of performing Real Time PCR testing with specific functionality and performance-based requirements of the system. The proposal shall provide descriptive literature that meets the following specifications:

Characteristics of the Laboratory Instrument System

· The instrument(s) must contain random access technologies on an integrated platform that improve workflow processes in the laboratory. It must reduce turnaround times, minimize individual analyzers and maximize efficiency.

· The analyzer(s) must provide a high throughput that can handle approximately 32 tests in 2 hours.

· The equipment must be able to run individual samples without the need for batching or running external daily Quality Control (QC), provide for reagents room or refrigeration temperature storage conditions, and have the ability to run different assays simultaneously.

· Configuration shall include an on-board QC program capable of printing/displaying all internal QC/calibrations to facilitate the detection of outliers or failures.

· The instrument(s) must provide closed-cartridge technology to reduce cross-contamination.

· Bar-coded data entry capabilities.

· Fast, easy setup and walkaway operation. CLIA “Moderate Complexity” designation.

· Reagent stability should be at least 12 months and can be stored at room temperature.

· The analyzer(s) must have the capability to process more than 4 different assays at the same time.

· The vendor must provide the reagents, controls and consumables necessary to perform the tests. The vendor is required to provide instrumentation that meets all laboratory requirements. Discontinued models are not acceptable.

· The Contractor shall provide all necessary startup reagents, organisms and supplies required to complete a full validation and correlation study.

· The vendor must provide the appropriate UPS for the instrument and replace it when necessary. Printers must also be provided and replaced when broken.

· The analyzer must have a dedicated STAT port that accepts samples at any time.

· Each system’s models/ modules must provide accurate test assay results for sample specimens up to the manufacturer’s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

· Testing equipment must be new, state-of-the-art equipment. Remanufactured and discontinued modules will not be accepted.

· The instruments must meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

· All work shall be performed in accordance with the guidelines established by Federal, State and local ordinances, FDA manufacturer’s guidelines, and with all terms, conditions, provisions and specifications provide herein.

Testing System

· Fully-integrated System

· Automated real-time PCR Testing

· Self-contained Test Cartridges

· CLIA Moderate Complexity

· Random Access Platform

· Bi-directional Interface

· User friendly software that provides access to amplification curves within runs

· Ability to run multiple assay protocols simultaneously

· 6 Color excitation and detection modules for multiplexing; provides thermal and optical data in real time, increasing the number of targets and controls available in tests design and implementation

· Shall transmit data through a network connection if required Software:

· Contractor shall provide all necessary software/hardware (drivers) for bidirectional interface with Data Innovations

· Shall provide supporting documentation required to maintain or improve level of data retrieval, which may be used for epidemiology measures

· Shall be capable of printing/displaying all internal QC/calibration

· Shall be compatible with the present barcode styles formats being utilized Ancillary:

· The printer and the UPS shall be replaced by the contractor when inoperable for the lifetime of the contract

· The contractor shall provide all upgrades to the equipment hardware and operating system software, all-inclusive with established cost

· An operator’s manual shall be furnished with each model supplied. Electronic formats (e.g., on CD) are acceptable. Procedures shall be provided in accordance with the Clinical and Laboratory Standards Institute (CLSI) format

· A Service manual shall be furnished with each model supplied. Electric formats (e.g., on CD) are acceptable

III. Requirements of Services to be provided:

1.1. Mandatory Requirements:

1.1.1. System Requirements

1.1.1.1. Contractor must provide an FDA approved, CLIA Moderately Complex, fully-integrated and automated analysis instrument that uses a Random Access Platform for nucleic acid analysis for the rapid detection of MRSA from patient specimens.

1.1.1.2. Contract will allow flexibility for future expansion of testing, using the same instrumentation footprint; to include, but not be limited to, MRSA/SA BC, C.DIFF/EPI, MRSA nares, CARBA R, CT/NG, TV, STREP A, BCR/ABL, SARS-CoV-2, CoV-2/FLU A & B/RSV, and MTB/RIF .

1.1.1.3. Sequential Testing Capability: System should be able to run individual samples without the need for batching.

1.1.1.4. System must use unprepared samples with little or no preparation time (measured in minutes).

1.1.1.5. Must provide reagents that can be stored at room temperature.

1.1.1.6. System should be able to conduct the test and give results rapidly (measured in hours including preparatory time).

1.1.1.7. System should have the ability to start and run multiple assay protocols simultaneously without stopping currents runs.

1.1.1.8. User Friendliness: a) should not require a molecular trained technologist to operate the analyzer or to perform the test b) must provide software and/or supporting instrumentation required to maintain, or improve levels of data retrieval, which may be used for epidemiology, or cost-decreasing measures; c) ease in handling and resolving errors;

1.1.2. Instrumentation:

1.1.2.1. System must include an on-board QC program capable of printing/displaying all internal QC/calibrations (e.g. when QC is out-of-limits).

1.1.2.2. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote.

1.1.2.3. 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 <80% at 32C (89F) without condensation. An electronic operator’s manual must be furnished with each model supplied.

1.1.3. Installation, including Verification/Validation, Training:

1.1.3.1. Technical support specialist to assist in equipment installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), staff training and methodology problems and questions.

1.1.3.2. All necessary procedure manuals, troubleshooting manuals and operator manuals (also available on computer disk format). Procedures should be in the Clinical and Laboratory Standards Institute (CLSI) format.

1.1.3.3. Vendor must provide education/training on site – basic operating and maintenance training during installations or update to the equipment.

1.1.3.4. The Contractor shall provide reagents for the validation and implementation of new assays and the cost will be borne by the contractor. 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.

1.1.4. Supplies:

1.1.4.1. All reagents, controls, calibrators and disposables required for operating the analyzer and producing quality results should be listed as an addendum in the pricing schedule.

1.1.4.2. Frequency of supply shipments. Contractor should provide initial inventory based on prior use, when available, then establish a standing weekly/monthly/quarterly shipment based on current use, with the capacity to fill emergency requests on-demand.

1.1.5. Repair and Maintenance:

1.1.5.1. Service will include replacement or repair of all ancillary equipment.

1.1.5.2. Vendor will provided technical support either by phone or on-site support.

1.2. Value-Added Characteristics: These characteristics are not mandatory, but will be considered as value-added in the Best-Value Determination. Value added characteristics may include, but are not limited to:

1.2.1. Utility requirements (electrical, media disposal, etc…). Include all necessary MSDS.

1.2.2. Environmental requirements (heat/cool, humidity, light, etc…) for instrument and testing material storage.

1.2.3. PMI maintenance required. Contractor should define maintenance requirements and indicate which are performed by the user; which are not.

1.2.4. Software should be compatible with all barcode styles and bidirectional interface to LIS, where applicable.

1.2.5. Should provide necessary software/hardware (drivers) for bi-directional interface with Data Innovations, or other LIS vendor, LIS, where applicable. Should transmit data through a network connection; if it only communicates using a serial port, the vendor should provide the necessary equipment (cable and Lantronix) to change the serial port to network communication.

1.2.6. Equipment should include a UPS system that has a 24 hour backup capability.

1.3. Support Services:

1.3.1. Ability to provide service sufficient to meet the needs of the using facility Monday through Friday 6:00am to 6:00pm. Field engineer service support must be available within twenty four (24) business hours of notification, Monday through Friday). 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). Requests for services will be through one contractor.

1.3.2. A service hotline with technical support will be available Monday thru Friday 5am to 6pm PDT to provide direct access to technical support. All calls must be answered within one hour via telephone.

1.3.3. Service is to include all travel, parts for repair or replacement, and labor.

1.3.4. Vendor is to provide alternative testing if the equipment requiring repair is down in excess of 24 hours at no additional cost to the Government. Costs to be reimbursed by vendor for those costs incurred during downtime to include but not limited to, media, labor, and reference laboratory services.

1.3.5. 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

1.4. Upgrades/ Test Volume Adjustment:

1.4.1. Vendor will work with each facility to adjust reagent supply to match workload changes. Assessment of test volumes and testing needs at the designated facilities at NF/SG VHS shall be automatically extended to any and all new NF/SG VHS facilities acquired during the contract period.

1.4.2. (Where applicable) Automatic software updates as available and within two months of release, and will at all times maintain compatibility of systems with whatever host LIS is in place, especially when vendor software is upgraded.

1.4.3. Provide necessary upgrades to equipment hardware at no additional charge to the Government.

A. Basic Requirements: The system must contain random access technologies that improve workflow.

1. Microbiology Analytical Systems for DVA, NF/SG VHS:

a. Expected throughput: Ability to manage testing workflow of high volume laboratory with where at least 90% of the testing is performed during the day shift (6:30am-4pm) Sunday through Saturday.

b. Instrument integration plan: DVA, NF/SG VHS facilities on similar platforms; utilizing same supplies.

c. Specimen integrity evaluation on all supplies as needed at no additional cost.*

d. Quality controls are performed new supplies and monthly due to patient specimen testing.

2. Automation System – Pre/ Post Analytic and Line Processing- DVA, NF/SG VHS

a. Processing — receives specimen and record time, accession specimens, attach barcode labels to specimen. The information system component of this laboratory automation system (LAS) must be able to communicate with Lab information system for ordering information to be sent from Lab information system to the System manager and shall include but not be limited to: order code or name, order priority, type of specimen, accession number, container id, collect date and time, and receipt date and time.

b. Patient Identification- the barcode of the patient specimen must be validated multiple times throughout the automation system to assure positive patient identification at all times.

c. Optimized automated delivery of specimens to Microbiology analyzers for parallel processing to provide best turnaround times and meet specimen handling requirements.*

d. Automated tracking of specimen location and testing status of a specimen.

e. Capping and recapping system in an enclosed environment to prevent distribution of bio-hazardous aerosols.

3. Reagents and Supplies:

1. Inventory Management: The Contractor is required to provide a continuously stocked inventory of reagents, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Unexpected changes in methodology/technology shall be at the expense of the vendor. Alert/Notification of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to lab chiefs or designee. Separate deliveries of products shall be shipped to each site (DVA, NF/SG VHS facilities). Failure to reserve adequate inventory will result in default.

2. Items Included: The vendor shall provide/install any routine and special items required to operate / maintain the equipment/analyzer in optimal condition such as but not limited to: linearity standards, consumable equipment parts, required replacement parts for maintenance or service etc. Any items excluded by the vendor but required for operation of the system at any time, must be delineated in their technical proposal. The cost of any excluded items must be disclosed in the cost proposal.

3. Special Handling for Emergency Orders of Supplies: If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival at the government site of the monthly standing order or routine supply delivery. In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routing supply delivery or inventory management, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor shall deliver to the government site, in the most expeditious manner possible, without additional cost to the government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).

4. Quality of Reagents, Supplies and Disposables: The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality 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). In the event that the supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order, if verbal order is received by 1 pm EST time, for priority delivery from the government activity. This shall be done at no cost to the government, in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume). The vendor shall reimburse each facility for any costs/supplies related to tests performed by another vendor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure.

5. Returned Goods: The VA is responsible for inspecting all products shipped hereunder and give the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor. After acceptance, no products purchased hereunder may be returned without the prior authorization of the contractor and in conformity with their return policy. All returns of non-defective products are subject to a restocking charge. No returns will be authorized after 120 days following shipment to VA

6. Shipping Charges: For reagents with hazardous constituents, vendor must provide a mechanism for the Laboratory to meet local discharge requirements. No delivery charges for shipping or fee handling. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote and included in CPT.

B. Additional System Requirements:

1. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the vendor shall be performed within 60 days after request.

2. Patient Mean Analysis Quality Control program: (Does not apply for Qualitative Test). Required to have a QC program available on instruments or through middleware to monitor trends of test methods.*

3. Comprehensive on board QC Program, including Troubleshooting or System Validation QC material. The system must have quality control data storage and reporting capabilities, the ability to view and print daily and monthly QC results, troubleshoot unsatisfactory results and system errors, validate archive data document all information.

4. Upgraded Software/ Equipment: The Contractor shall provide all upgrades to the equipment hardware and operating system software 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.

5. Bar Codes: All bar code readers must be capable of reading and decoding any label when manually applied to a specimen tube in accordance with the guidelines described in the Clinical and Laboratory Standards Institute (CLSI) standard, Laboratory Automation: Bar Codes for Specimen Container Identification, NCCLS Document Auto2-A, Approved Guideline, Vol. 20, No. 19, October 2005.

6. New Test Methods: New tests on-line vendor/technical support specialist shall perform all validation studies including installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards) and normal range studies at no initial charge.

C. Maintenance and Service Support Requirements:

1. Minimal System Maintenance required, including limited reagent preparation prior to use.

2. Computer Patient Data Handling: No hardware, containing any VA patient information is to be removed from any location, without the approval and removal of data by the VA information technology department. Failure to comply with this VA requirement may result in prosecution.

3. Preventative Maintenance: Contractor shall 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. Minimum of 2 per year per instrument unless documentation for volume performed denotes not required for optimum quality of operation.

4. Emergency Repair: Emergency repairs shall be performed after notification that the equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. The contractor shall perform emergency repair service within 24 hours of time of notification of the malfunction except when an ordering facility elects reduced service at contract agreed reduction. The contractor shall provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair shall be borne by the contractor. 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 arrival. (b) Serial number type and model numbers(s) of equipment (c) time spent for repair, (d) description of malfunction and (e) proof of repair.

5. Maintenance Support: Service repair person locally based within NF/SG VHS geographical area.*

6. Maintenance Credit for Equipment Malfunction: If a machine remains inoperative due to a malfunction through no fault or negligence of the government for a total of 24 hours or more, the contractor shall be assessed damages at the rate of 1/30 of the preceding average three month CPT billings times the total number of days certified as downtime for each incident shall start from the time the user makes a bona fide attempt to contact the contractor's designated representative at the prearranged contact point until the machine is returned to good operating order less any non-contracted maintenance (emergency repairs) days.

7. Replacement of Laboratory Equipment: During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the representative of the government to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the contractor.

8. Failure Mean Time Disclosure: The contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. The Contractor shall provide emergency backup equipment.

9. FDA Approved Instruments and Methods: Only instruments which are FDA approved will be considered, and must be operational and interface with VA Laboratory Computer systems and upgrades. Test methods must be FDA approved with limited recalls due to product failures. This must be a "turn-key" system.

10. Operator Procedure Manuals: Two Operator and Service manuals along with CLSI compliant procedures must be furnished for each instrument model supplied.

D. Training and Technical Service Training:

1. On-site training by vendor shall also be supplied to all laboratory staff as needed.

2. Vendor shall provide/install/train users on the data management system with in house training. On-site refresher training in renewal option years of the contract shall also be made available annually.

3. In addition, the contractor shall provide supplemental operating training to above government personnel, without additional charge to the government, upon installation of the upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

4. The contractor, at his/her discretion, may make additional training available at his/her facility on terms and conditions mutually agreed upon by the agency and the contractor.

E. Installation and Initial Set Up:

1. SITE PREPARATION: Site preparation specifications shall be furnished in writing by the contractor as a 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.

2. SPACE REQUIREMENTS, SYSTEM SPECIFICATIONS ETC.: Configuration of the proposed equipment must be able to conform to the space previously allotted for this function. System specifications must all be disclosed in the proposed space. Crossover from current to new instrumentation must be performed timely with no interruption in patient care laboratory service.*

3. OWNERSHIP OF EOUIPMENT: Ownership of the equipment shall remain with the contractor. All accessories (unused consumables, etc) 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, shall remove the equipment. The contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for decontamination of the system, packing and shipping required to remove the analyzer within ten (10) calendar days.

4. STANDARD AND ACCEPTANCE OF PERFORMANCE: This paragraph establishes a standard of performance that must be met before any equipment listed on the deliver order is accepted by the government. This also includes replacement, substitute machines and machines that are added or field modified after a system has completed a successful performance period.

a. The performance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the contractor's technical specification or as quoted in any contract at an effectiveness level of 99% or more. Operational use time for performance testing for a system is defined as the accumulated time during which the machine 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 fide 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.

b. 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.

c. The government will 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.

5. GOVERNMENT's RESPONSIBILITY: The user will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user will maintain appropriate daily records to satisfy the requirements of this paragraph.

6. INSTALLATION PROCEDURES:

a. 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 in coordination with the facility Biomedical engineer. 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 continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

b. Upon completion of installation the equipment shall be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government will accept installation with guarantee date commencing ten calendar days after installation

c. Vendor shall provide equipment installation and possible reinstallation at minimal costs if the equipment is required to be moved due to construction or laboratory redesign.

F. Special Requirements for Awarded Contractor:

Vendor must meet, or improve, each Laboratory's existing turn-around times as a minimum, by any change in instrumentation. Proposal should include provisions for back-up instrumentation so the Laboratory can provide essential testing without compromising turn-around for all tests on menu. Method Performance/Comparison shall be at the expense of the Vendor, shall include linearity material and reagents, and be consistent with current CLSI and related documents, CAP Standards and Federal Regulations, for the following:

1. Correlation studies for each analyte. A minimum of 20 samples (30 for new tests or technology), spanning the reportable range, shall be run by the present and the new contracted method. Vendor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, analysis, and meet current standards defined by CLSI.

2. Linearity analysis shall be performed on new contracted instrument(s) for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines. (Does not apply for Qualitative Test).

3. Precision study shall be performed utilizing normal and abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal and abnormal controls.

4. Reference Range: Determine a reference range for each test following CLSI guideline C-23A. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols should be used:

a. A verification of the manufacturer's suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer must provide specific information defining how the suggested range was determined. A minimum of 30 reference individuals must be used to verify the manufacturer's range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.

b. If the suggested manufacturer's range is not appropriate for the patient population, a reference range must be established. Establishing a reference must follow NCCLS C-28A guidelines. This requires a minimum of 100 reference individuals be used to establish a reference range.

c. If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternate test must be provided.

5. All technical procedures must be provided electronically by vendor in CLSI format, using software compatible with each Laboratory's computer system, for local modification to meet CAP requirements.

6. Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms.

7. Vendor to provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., vendor is to provide all manpower and reagents/supplies to do correlation studies).

G. Early Termination:

The ordering activity reserves the right to terminate the contract at any time under the provisions of the FAR Clause 52.249-4 Termination for the convenience of the Government. If the ordering activity terminates the contract prior to expiration of the fiscal year, the contractor may assess a termination charge. The termination charge shall be no higher than the difference between the order(s), price(s) and the price applicable for the number of months and monthly rate the tests were actually run. The termination charge may be assessed only for the fiscal year in which the order is terminated.

H. Equipment Removal:

The vendor shall remove all equipment within 60 days after notification of the expiration of the terms of this contract but not until the completion of new vendor’s equipment installation inclusive of completed cross over studies. Vendor shall not remove hard drive from premises. All drives with VA information remains the propriety of VA. All service personnel shall be instructed regarding this requirement.

I. Best Value:

These characteristics are not mandatory but will be considered as value-added in the Best-Value Determination. Value added characteristics may include, but are not limited to:

a. Instrumentation to fit into current footprint to maximize space utilization and minimize costs of remodeling.

b. Ability of the instruments to handle primary sample tubes and aliquot containers of various sizes.

IV. JCAHO, VHA (VETERANS HEALTH ADMINISTRATION) AND OTHER STANDARDS:

a. The contractor shall notify the VA Contracting Officer immediately at the North Florida/South Georgia Veterans Healthcare System, 1601 SW Archer Road, Gainesville Florida 32608 (telephone no. (352) 376-1611, X-3041 or fax no. (352) 374-6117) of any change in the licensure, or status as non-excluded or sanctioned by HHS (Health & Human Services) or Office of Inspector General. Any change in status is grounds for immediate termination.

b. The contractor shall immediately notify the Contracting Officer at the North Florida/South Georgia Veterans Healthcare System, 1601 SW Archer Road, Gainesville Florida 32608 of any merger, acquisition, or affiliation agreement; any legal or governmental action initiated against the contractor for professional negligence, violation of law, bankruptcy, lapse or material change in liability insurance coverage, any other problem or situation that might impair the ability of contractor (offeror) to carry out its obligations under the contract. Any change in status is grounds for immediate termination.

c. The contractor represents and warrants that it is in compliance with Medicare, Medicaid and any other related Federal or State Statutes, regulations, rules or policies and that neither they nor their agents, officers, employees, independent practitioners assignees or successors in interest are excluded from participation in the Medicare, Medicaid or related federal or state programs. Further, contractor shall immediately notify the Contracting Officer of the exclusion from such programs of any of its agents, officers, employees, independent practitioners assignees or successors in interest. Such exclusions shall be grounds for immediate termination of the contract.

d. The contractor shall conform to all issues addressed in the VA Medical Staff By-laws and the VA Medical Center Memorandums pertaining to delivery of services.

e. Contractor agrees to maintain services as specified, reporting systems and quality control as specified herein. Failure to comply with the specified terms and conditions and/or adverse reports from external monitoring agencies, which indicate poor quality of care, may be grounds for termination of the contract. Immediate (within 24 hours) notification must be given to VA regarding adverse reports and action by a regulatory agency.

f. The services specified in the Schedule of Services may be changed by written modification to this contract. VA Contracting Officer will prepare the modification.

g. The contractor shall furnish the services specified in the Schedule of Services to this contract to VA when authorized by VA Chief of Staff or designee.

h. HIPAA: Contractor agrees to comply with the requirements of the Health Insurance Portability and Accountability Act (HIPAA) and with the provision of other appropriate federal laws, rule and regulations.

i. Qualifications: Proposals shall be considered only from offerors whose Pathology and Laboratory Medicine Services are licensed as required by CLIA 88.

j. License: Prior to award the offeror shall submit proof that he holds an un-revoked U.S. License which is issued required by CLIA 88.

k. Certification: The offeror certifies that he shall comply with the requirements outlined with respect to donors, containers, delivery, etc.

l. Personnel Policy: The Contractor shall assume full responsibility for the training, certification and protection of its personnel furnishing services under this contract, in accordance with the personnel policy of the Contractor, such as providing worker’s compensation, professional liability insurance, health examinations, income tax withholding, and social security payments. The parties agree that the contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose.

V. REFERENCES:

A. Current Test Menu B. Current Vendor equipment list C. Independent Government Cost Estimate

VI. DELIVERY:

A. Terms of Reagent Delivery – included above B. Terms of Installation – Included above C. Terms of Service Delivery- Included above

VII. PROGRESS AND COMPLIANCE:

A. Annual review of contract and compliance performed at set date of each contract year in evaluation prior to the contract annual renewal deadline. Annual review outlined in paragraph to include compliance with all terms of contract including but not limited to service expectations, billing accuracy, delivery expectation, uptime expectations.