36C24820Q0346-001.docx

Hemoglobin A1c Testing – CPRR Contract

STATEMENT OF WORK-BRAND NAME or EQUAL (BIO-RAD D100 with Reagents)

1. GENERAL: The Contractor shall provide a Cost Per Reportable Result (CPRR) contract for the C.W. Bill Young VA Medical Center (CWBY), Bay Pines VA HCS in Bay Pines, Florida, for an Indefinite-Delivery Contract (IDC), Requirements Type with a Base Year and Four (4) Option Years including two (2) each Analyzers, reagents, supplies, installation, training, and service of the equipment (for life of agreement) as identified below. All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with the FDA and manufacturer's guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.

ESTIMATED COST PER REPORTABLE RESULT (CPRR):

· The contractor is required to furnish: (a) two (2) Analyzers (contractor is required to provide new state-of the art automated analyzers/equipment); (b) all scheduled and unscheduled maintenance to keep the equipment in good operating condition including upgrades; (c) operational hardware and software upgrades (within 60 days of issuance); (d) user training for two (2) VA personnel, including all associated expenses; (e) All reagents, controls, calibrators, linearity material, and consumables, and includes all shipping charges for such items; and (f) Contractor is required to provide delivery, installation, and all validation / correlation studies (defined by the Collage of American Pathologists - CAP) of the equipment, including all delivery and return shipping costs at end of contract. All reagents and supplies for the instrument / test validation correlation studies shall be supplied at no additional cost. If at any time during the contract period, tests are not available on this list, the Contractor shall reimburse the government for any additional costs associated with the procurement of another source of test performance.

· Required Test Menu for CPRR Testing:

2. EQUIPMENT: The contractor is required to provide new state-of the art automated analyzers / equipment. Discontinued models are not acceptable. 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. The proposal shall provide descriptive literature that meets the following specifications:

Functionality and Performance Specifications of the Automated Analyzer:

· The system shall have High Performance Liquid Chromatography (HPLC) methodology with variant detection. There should be no interference from Hemoglobin S, C, D, E, carbamylated Hb, or labile HbA1c. There should be no interference from fetal Hb up to 30%.

· The system shall be certified by the National Glycohemoglobin Standardization Program.

· The complete system (two (2) analyzers, two (2) printers, and two (2) monitors, etc.) must fit within current space allocations, 36" (W) x 34" (D) x 36” (H), including space required for analyzer ventilation.

· The system should have a Coefficient of Variation (CV) must be less than 2.5%.

· Expected throughput: Ability to manage testing workflow with approximately, 87,523 tests/year with testing 6 days per week. The system should handle high-volume workloads with a turnaround time of 90 seconds or less per test.

· On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (3) months for reagents.

· A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system, Data Innovations Middleware.

· The testing method should not require sample pre-treatment.

· The system shall have the capability to detect out of range and expired quality controls / calibrations.

· Analyzers must have accurate capability of monitoring reagent usage, be capable of maintaining/storing on board supplies/reagents, and provide reagent inventory upon request, in real time.

· Reagent handling should include on board reagent stability greater or equal to 30 days. Ability to replenish reagents while instrument is in operation and must have on board calibration and lot (calibrator and reagent) tracking. All consumables should be RFID-tagged for fully automated traceability and convenience.

· The system has the capability to backup / archive stored patient result data, quality control, instrument configuration, and calibration information to CWBY network drive location. It must be easily and readily retrieved and readable within a time frame consistent with patient care needs.

Additional System Requirements:

· 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 Contractor 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 other analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the Contractor shall be performed within 30 days after request.

· 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.

· New Test Methods: The Contractor’s technical support specialist shall perform all validation studies for initial installation or adding assays to the testing platform and include: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), carryover studies, and normal range studies at no initial charge.

3. GENERAL REQUIREMENTS:

· 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 manufacturer's 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.

· Ownership of Equipment shall remain with the contractor. All equipment accessories (hardware are 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 remove the equipment. The contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within ten business days. The hard drive will remain within the VA.

· 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 an 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. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order upon mutual agreement.

4. MAINTENANCE: The contractor shall provide all maintenance (labor and parts) 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.

5. SERVICE: The contractor guarantees availability of servicing and replacement parts for the term of this contract. Contractor shall provide full service on site technical support for CWBY which shall be available 8 hours/day, Monday - Friday. Telephone technical support shall be available 24 hours daily with follow up on all calls within one hour of initial call. Following determination that service is required, technical on – site support must be provided within 24 hours. The contractor shall provide maintenance (labor and parts). The government shall provide the contractor access to the equipment to perform maintenance service according to the maintenance and service terms below. The contractor will provide all parts and labor needed to repair the malfunction and to keep the equipment in good operating condition and subject to security regulations. Travel, per diem and other expenses associated with the repair will be borne by the contractor. The contractor shall furnish a malfunction incident report to the institution 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.

6. TRAINING: The contractor, without additional charge to the government, shall provide training for at least two (2) key operating personnel at the time of installation of the contractor's equipment. In addition, the contractor shall provide supplemental key operator training to the (2) two 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.

7. CONTRACTOR TESTING AND INSPECTION: The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The VA has the right to test all services ordered under the contract at all times and places throughout the term of the contract. Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract.

8. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: The VA shall require the contractor to deliver the equipment ordered under this contract not later than THIRTY (30) calendar days after receipt of notice of award. Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training The VA reserves the right to request a ninety (90) day test and evaluation of one or both pieces of equipment prior to placing a delivery order under the contract If the test and evaluation is not successful as determined by the CO and POC for that VA, those individual VA's will not be required to continue with placing a delivery order under this contract, and no default or penalty will accrue.

· Reagents Delivery Terms: The contractor shall deliver reagents, shipping cost included, as needed (just in time) from CALL orders within 48 hours.

· Quality of Reagents, Supplies, and Disposables: The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP). In the event that the supplies to include 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 herein, the contractor is required to deliver the supplies within 48 hours of receipt of the verbal order for priority delivery from the government activity. This will 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).

· Returned Goods: the contactor shall pay for the return of any reagent, consumable or supply.

· 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 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.

· Upon completion of installation the equipment will 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 shall accept installation with guarantee date commencing ten calendar days after installation.

9. REGULATORY REQUIREMENTS: If the product(s) included in this solicitation are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated there under.

10. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.

11. MANUFACTURED PRODUCTS: Materials furnished shall be of the current productions of manufacturers regularly engaged in manufacture of such items. Approval by Contracting Officer is required of deviation from products and manufacturers as shown in the schedule of items. Shelf-life of all consumables shall be at least ONE YEAR from shipping date unless FDA requires different expiration date.

12. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

13. CONTRACT ADMINISTRATION DATA: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority and no adjustment will be made in contract price to cover any increase in costs incurred as a result thereof.