36C24718Q0713-001.docx

STATEMENT OF WORK

Polymerase Chain Reaction (PCR) Equipment/System to Perform Molecular Diagnostic Patient Testing Described Herein Through a Cost-Per-Test Contract/Task Order

Cost-Per-Test (CPT): Includes PCR equipment and necessary peripherals (printer, uninterrupted power supply, bar code reader(s), etc.) to perform and report molecular testing (specified below), delivery and installation, shipping and handling, all reagent/kit products, specimen collection kits, training for Government personnel (includes airfare, room, board, and training material), all necessary maintenance and service to keep the equipment in good operating condition (this includes both preventive maintenance and emergency repairs), and supplies/materials necessary to perform correlation study testing that is prescribed by the Clinical Laboratory Standards Institute (CLSI).

1. BACKGROUND: VA Medical Center Birmingham, AL (BVAMC) currently uses a PCR Molecular Diagnostic Testing Platform to perform a comprehensive menu of tests through a cost-per-test (CPT) contract. The Government must obtain a new CPT contract to continue uninterrupted patient testing. This new requirement is expected to begin the effective date of this action and will include four (4) one-year option periods.

2. SCOPE: BVAMC needs this fully automated equipment to perform the specified patient testing through a CPT contract in Pathology & Laboratory Medicine Service (P&LMS) at BVAMC, 700 South 19th Street, Birmingham, AL. Offers will be accepted, and a contract awarded to a vendor who provides such on a CPT basis.

2.1. The equipment shall be able to simultaneously perform the required testing and meet the performance characteristics for accuracy and precision as defined by the Clinical Laboratory Improvement Act (CLIA) and the CLSI.

2.2. The equipment shall maintain or reduce the number of work stations or overall labor required to accomplish the required testing.

2.3. The equipment shall provide the following required test menu on a single PCR testing platform:

* NOTE: All volumes/test numbers are estimates based upon prior history and known directives. Vendor will work with BVAMC and VA Contracting to adjust reagent supply to match workload changes, when necessary, through appropriate modification(s).

2.4. There shall be flexibility for future expansion of testing, using the same instrument footprint, as needed. If additional testing, new or reformulated, is/becomes available, those tests may be added to the testing menu, through appropriate modification(s).

3. GENERAL REQUIREMENTS:

3.1. The vendor shall provide all supplies and services as described herein. The Schedule of Pricing below shall be utilized by interested offerors to submit their cost proposal. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees shall be clearly indicated in the price quote.

3.2. The purpose of this SOW is for the VA to obtain the greatest benefit in response to the requirements.

3.3. Offered models of equipment shall be capable of producing accurate and reproducible assays on patient samples. Model shall provide accurate test assay results for sample up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

3.4. Offered equipment shall be new and in current production as of the date the offer is submitted. All offerors must submit an offer for new equipment, not previously used. Remanufactured and discontinued models will not be accepted.

3.5. Contractor shall provide printer for analyzer and provide replacement printer(s), as needed, if applicable, at no extra charge.

3.6. Contractor shall provide all manuals, documents, and initial supplies. Includes the right to reproduce any printed materials supplied with the product for the purpose of using the product.

4. SYSTEM REQUIREMENTS:

4.1. Vendor shall provide a Food & Drug Administration (FDA) approved, fully-integrated and automated analysis instrument that uses a random-access platform for real-time PCR testing via self-contained test cartridges. If applicable, the instrument must use Windows-based program(s) with tough-screen user interface that is easy to read and to navigate. All hardware shall run on Windows 7 or newer version of Windows, if applicable.

4.2. The system shall allow the medical technologists to multitask (QC review, troubleshooting, etc.) during system operation without interrupting patient testing and reducing technologist manual interventions.

4.3. The system shall include a bi-directional, bar-coded computer interface compatible with the current VA VISTA hospital information system or other VA compatible software. The system must include the necessary software for bi-directional interface with Data Innovations, or another LIS vendor, LIS, where applicable. Software shall be compatible with all barcode styles.

4.4. The system shall allow possess ease of use, user friendly and walk-away capability that is not labor intensive and avoids unsafe aerosol producing steps including maintenance requirements. Ease of use includes minimum set up time, automated sample barcoding and minimal amount of time to perform daily, weekly, and monthly maintenance.

4.5. The system shall be a closed system that eliminates contamination and does not require special operating environments.

4.6. Sequential Testing Capability: The system shall be able to run individual samples without the need for batching.

4.7. System shall have sufficient capacity and throughput to meet the volume, variety, and service demands. The system shall be flexible to allow expansion of the testing space/configuration, with an initial minimum of at least 25-test capacity per run.

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

4.9. Contractor shall provide reagents that can be stored at room temperature, as applicable.

4.10. The system shall be able to conduct the test and give results rapidly - measured in hours including preparatory time - expected turn-around time: < 1 hour. Rapid flu test results expected turn-around time: 20-30 minutes.

4.11. The system can start and run multiple assay protocols simultaneously without stopping current runs.

4.12. The system shall have walk-away capability – no manipulation needed once on the instrument; no centrifugation, heating or manual reading.

4.13. The system shall not require a molecular-trained technologist to operate the analyzer or to perform the tests.

4.14. The system shall 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.

4.15. The system shall include an on-board Quality Control (QC) program that is fully compliant with College of American Pathologist (CAP) and capable of printing/displaying all internal QC/calibrations (e.g. when QC is out-of-limits) and patient results.

5. REAGENTS AND SUPPLIES REQUIREMENTS:

5.1. Inventory Management - The Contractor is required to provide a continuously stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Alert/Notification of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to Chief, P&LMS or designee.

5.2. Any items excluded by the vendor but required for operation of the system at any time, shall be delineated in their technical proposal. The cost of any excluded items shall be disclosed in the cost proposal.

5.3. 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).

5.4. Hazardous Constituents - For reagents with hazardous constituents, the Contractor shall provide a mechanism for the Laboratory to meet local discharge requirements.

5.5. Shipping Charges - No delivery charges for shipping or fee handling.

5.6. Shipping Schedule – The specific shipping schedule shall be determined/established in conjunction with the BVAMC Microbiology Supervisor or designee. Shipments shall be made to BVAMC as scheduled, or as ordered.

5.7. Special Handling for Emergency Orders of Supplies - If additional requests for emergency supply delivery are required by the BVAMC, the contractor shall honor them until the arrival at the government site of the monthly standing order or routine supply delivery.

6. MAINTENANCE AND SERVICE SUPPORT REQUIREMENTS:

6.1. Maintenance and service support is provided as described herein at no additional cost to the Government.

6.2. Contractor shall provide technical support by telephone 24-hours/day, 7 days/week, 365 days per year, with call back within one (1) hour.

6.3. The Contractor shall provide maintenance to keep the equipment in good operating condition and subject to security regulations. The BVAMC will provide the contractor access to the equipment to perform maintenance service.

6.4. 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.

6.5. Repairs/Service - The Contractor shall provide service sufficient to meet the needs of BVAMC Monday through Friday, 8:00 a.m. – 4:30 p.m., excluding holidays. On-site technical field service representative must be provided the same day if the system is non-functional after trouble shooting fails and a resolution is not accomplished before the call-time cutoff. If after defined cut-off time, on-site technical field service representative shall be provided the following morning. All repairs shall be complete within 24 hours from the time the field service representative arrives. Requests for services shall be through one vendor.

6.6. Service shall include replacement or repair of all ancillary equipment (printer, bar code reader, etc.), as needed.

6.7. The contractor shall provide all tools, parts, and labor needed for preventive maintenance and repairs. Travel, per diem, and other expenses associated with the preventive maintenance and repairs shall be borne by the contractor.

6.8. Malfunction Incident Report - The contractor shall furnish a malfunction incident report to the department upon completion of each maintenance call. The report shall include, as a minimum, the following:

6.8.1. Date and time of arrival;

6.8.2. Serial number type and model numbers(s) of equipment;

6.8.3. Time spent for repair;

6.8.4. Description of malfunction and;

6.8.5. Proof of repair.

6.9. Replacement of Laboratory Equipment - During the contract period, should the repair record of the equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination may be made 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.

6.10. Patient Data Handling – Due to the nature of this requirement (clinical laboratory diagnostic testing system), the contractor’s maintenance/service repair/installation person(s) may have incidental access to patient information during installation or servicing the contractor’s equipment. Any access to this information is incidental; it is not required by the contractor to perform the work outlined herein. No hardware is to be removed from any location, without written approval and removal of data by the VA Office of Information and Technology (OI&T) department. Failure to comply with this VA requirement may result in prosecution. See Equipment Removal Requirement.

6.11. The appropriate risk designation of the Field Representative/Service Engineer as determined by the Position Determination Automated Tool (PDAT) is: Low Risk – Tier 1.

6.12. Daily/Routine Maintenance – The system shall require minimal system maintenance. BVAMC technical staff (user) will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The BVAMC user will maintain appropriate daily records to satisfy the requirements of this paragraph.

7. EQUIPMENT AND SERVICE PROPOSED: The contractor shall complete the following table with the equipment and service plans proposed to meet the requirements specified in the Statement of Work herein.

8. TRAINING AND TECHNICAL SERVICE TRAINING REQUIREMENTS:

8.1. The contractor shall provide a comprehensive off-site (manufacturer facility) instrument training program that is coordinated with and timely to the equipment installation at no additional charge. Training shall include but is not limited to the operation of the system, quality control, interpretation and reporting of results, maintenance and trouble-shooting, data manipulation, and basic troubleshooting and repair. This shall be available for the maximum number of operating personnel at the time of installation. User training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc.

8.2. On-site education and training by contractor shall also be supplied to all laboratory staff regarding basic operation and maintenance.

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

8.4. 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.

8.5. Operator Procedure Manuals – Operator, service, and troubleshooting manuals along with CLSI compliant procedures shall be furnished for each instrument/system. All technical procedures shall be provided electronically CLSI format, using software compatible with Laboratory's computer system, for local modification to meet CAP requirements.

9. INSTALLATION, INITIAL SET UP, CORRELATION/VALIDATION:

9.1. 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.

9.2. Space Requirements, Systems, Specifications - Configuration of the proposed equipment shall conform to the BVAMC space currently allotted for this function with no structural changes/construction modification. System specifications must all be disclosed in the proposed space. A site visit/walk-through is available upon request and will be scheduled at the convenience of the BVAMC Clinical Laboratory. Arrangements shall be made through the COR, or designee, to establish an acceptable time to ensure minimum interruption of patient care. The site visit/walk-through must be requested in sufficient time to be completed at least 5 days before the close of the subject solicitation.

9.3. Installation – 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 in coordination with the facility Biomedical Engineer, P&LMS Microbiology Supervisor or designee, and P&LMS Laboratory Information Manager. 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. If progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced herein may be terminated until 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.

9.4. Crossover from current to new instrumentation shall be performed timely with no interruption in patient care laboratory service.

9.5. Contractor’s Technical Support Specialist shall perform/assist in set-up, method validation, correlation studies (evaluation/comparison data) sufficient to satisfy College of American Pathologist standards.

9.6. Upon completion of installation, correlations, validations, the equipment shall be turned over to the BVAMC P&LMS for use.

9.7. Contractor shall provide equipment installation/reinstallation at minimal costs if the equipment is required to be moved due to construction or laboratory redesign.

10. UPGRADES:

10.1. 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 to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. See Equipment Removal Requirement.

10.2. Upgraded Software/ Equipment - The Contractor shall provide all upgrades to the equipment hardware and operating system software to maintain the integrity of the system and the state-of-the-art technology, at no additional charge to the Government. These enhancements shall be provided as they become available and at the same time as they are being provided to commercial customers. This only applies to “system upgrades” that enhance the model of the equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, etc. This does not refer to replacing the original piece of equipment under the contract/order; however, it does refer to significant changes in the hardware operational capability.

11. OWNERSHIP OF EQUIPMENT: Ownership of the equipment shall remain with the contractor. All accessories furnished by the contractor shall accompany the equipment when returned to the contractor.

12. EQUIPMENT REMOVAL REQUIREMENT:

12.1. 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., as applicable) and shall be responsible for decontamination of the system, packing and shipping required to remove the analyzer.

12.2. The contractor shall remove all equipment within 10 days after notification of the expiration of the terms of this contract but not until the completion of new contractor’s equipment installation inclusive of completed cross over studies.

12.3. Contractor shall not remove hard drive(s) from premises. All drives remain the property of VA. All service personnel shall be instructed regarding this requirement. NOTE: Prior to instrument removal, the hard-drive(s) shall be removed in the presence of the BVAMC Information Security Officer (ISO), or VA designee, and retained by BVAMC OI&T, or VA designee, for destruction according to current BVAMC policy/procedure at the time.

13. Business Associate Agreement (BAA): Offerors shall submit with their respective proposal(s) a copy of their BAA, if available.

14. VA DIRECTIVE 6550 APPENDIX A: All offerors must complete and submit with their respective proposal(s) the following forms:

· Medical Equipment Pre-Procurement Assessment

· Manufacturer Disclosure Statement for Medical Device Security—MDS2