6640--CPRR TESTING FOR A1C HEMOGLOBIN INSTRUMENTS AND REAGENTS

STATEMENT OF WORK FOR COST PER TEST RESULT A1C 1) SCOPE: Contractor shall provide all equipment, reagents, standards, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the contractor owned analyzers and peripherals for the generation of hemoglobin A1c testing cost per test/reportable result (CPRR) services on behalf of VA Portland Hospital Care System Pathology and Laboratory Medicine Service and/or other VISN 20 facility. A services component shall also be included in the contract, to provide maintenance, repairs, upgrades, and training. Equipment, supplies and services shall be required for a base year period with four one-year options for renewal. Equipment, supplies and services shall be provided at VA Portland and/or any other VISN20 facility. 2) DEFINITIONS: Cost Per Test (CPT): Contractors shall provide a price for each patient, QC and survey sample test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, calibrators, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor s equipment and necessary for the generation and reporting of a patient test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs), (d) training for Government personnel, and (e) cost of shipping and handling of all reagents, calibrators, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor s equipment and necessary for the generation and reporting of test results. Contractors shall provide delivery, installation and removal of equipment at no additional charge. 3) GENERAL REQUIREMENTS: Clinical laboratory analyzer for Glycohemoglobin (Hemoglobin A1C) testing instrument shall be capable of producing accurate and reproducible assays on EDTA whole blood specimens by established in vitro diagnostic methods. The A1c result shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. Time for analyses must be less than 50 seconds per sample. Offered equipment shall be new equipment. Remanufactured and discontinued models will not be accepted. d) The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance to the commercial market. e) An operator s manual shall be furnished with each instrument supplied to VA and updates to manual shall be provided in a timely manner. f) Editable electronic copy in CLSI (Clinical and Laboratory Standards Institute) format of operating procedures and related training and maintenance documents shall be furnished with each instrument supplied to the VA. g) System must be certified by the National Glycohemoglobin Standardization Program (NGSP). h) All proposed equipment must fit the existing tabletop space at the facility, without the need for renovation work. Small scale re-arrangement of furniture is acceptable. Fitting existing space shall include conforming to the current structural parameters of each lab, in each facility, in terms of delivery, installation and lab space. (i.e. equipment size, weight, packaged size for delivery, electrical/voltage). i) Clinical Laboratory assays currently performed at the facility shall include, but may not be limited to the following assays. i. Glycohemoglobin (Hemoglobin A1C). j) Pricing: The (CPT) Per Test shall include all costs for: i. Equipment use, reagents, calibrators, microvials, consumable/disposable items, parts, accessories and any other items required for the proper operation of the contractor s equipment and necessary for the generation and reporting of a patient test result. ii. All necessary maintenance to keep equipment in manufacturer s operating conditions, both preventive maintenance, and emergency repairs. iii. Training for facility personnel operating equipment. k) The awarded contractor shall provide delivery, installation, set-up, validation and method comparison, including all supplies provided by the vendor, and decontamination, packaging and removal of equipment at completion of this agreement at no additional charge to the Government. 4) SYSTEM REQUIREMENTS The instrument testing for Glycohemoglobin (Hemoglobin A1C) shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below Meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA), the Clinical and Laboratory Standards Institute (CLSI), and the National Glycohemoglobin Standardization Program (NGSP). System shall have a Coefficient Variation (CV) of less than 2.5% A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric. Smart consumables - RFID technology used on all consumables: cartridge, prefilter, buffers and washes. Chip contains lot #, expiration date, open vial stability information, used & remaining tests, set values, etc. STAT area available. Automated specimen handling/loading system. No requirements for sample pre-treatment unless sample dilution required for acceptable total peak area count result. Minimal reagent preparation Minimal Maintenance Ability to store and transmit records (at least 24 hours of instrument throughput) in case of interface outage. On board reagent stability sufficient to accommodate both high and medium volume use. Contractor to provide expiration dates of at least three (3) months for reagents. Capability to store at least two years or 100,000 patient results in database for immediate recall. Instrument must be approved by the Food and Drug Administration (FDA) and shall have the following: i. Ability to monitor instrument performance. ii. On Board reagent inventory system. iii. Minimal carryover. iv. High volume cartridge for 10,000 tests requires only 1 calibration. Calibrators reconstituted automatically by the system. v. Redundant buffers & wash on-board. Buffers and wash can be changed while the system is running. vi. Result review automation/auto-verification functionality with on-board Advisor software: review chromatography flag normal vs abnormal results allow for batch result releasing eliminate the need for printing results individually standardize result review across operators vii. Automatic sample repeat without operator intervention when rule triggered. viii. System must use ion-exchange high performance liquid chromatography (HPLC) method. ix. Complete separation of the labile and stabile hemoglobin A1C. x. Methodology that provides no interference from common hemoglobin (Hb) variants, including Hb AS, AC, AD and AE xi. Able to detect and report HbA1c in the presence of Hemoglobin F, up to 30% HbF. xii.Able to detect and report HbA1c in the presence of Hemoglobin A2. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Software allows run to stop if calibration or QC fails - avoids loss of an entire run. Direct primary tube sampling from blood collection tubes. Must be cap piercing and require no pretreatment. Must read the barcode of each sample. Can perform off line dilution if required (i.e. short draws or pediatric tubes) Analyzer needs to detect low reagent volumes and alert end-user through software. Probe detects bottom of patient sample tube in order to optimize whole blood sampling. QC requirements 2 levels of QC every 24 hours Calibration must be easily performed and must maintain stability on the analyzer between calibrations. Calibrators must be traceable to a recognized national standards organization as stated by the Clinical and Laboratory Standards Institute (CLSI) and/or College of Clinical Pathology (CAP). Capability to detect out of range quality control. Remote support capability with secure software is available with VA approval. On- board QC data management system with a minimum storage capacity of 4 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data Time for analyses must be less than 45 seconds per sample 80 samples per hour. 5) INTERFACE REQUIREMENTS The C&A requirements do not apply, and a Security Accreditation Package is not required. The system should have the capability to interface with lab information system. There is no plan to interface the instrument at this time. 6) CONSUMABLE/REAGENT REQUIREMENTS a) All consumable supplies (reagents, standards, disposables, parts, accessories, etc.) required for the proper operation of the contractor's equipment and necessary to perform tests on the equipment shall be included. b) 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 routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the respective Lab Facility, Pathology and Laboratory Medicine Department, 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). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default. c) The contractor shall maintain on Government provided space a continuously stocked inventory of calibrators, reagents, supplies, disposables, parts, accessories, and any other material required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall 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). d) Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. Do we provide all startup material? The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all 6 of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format. 7) MAINTENANCE, REPAIR AND UPGRADE REQUIREMENTS With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provisions of contractor's existing Federal Supply Service Contract. i) 14. PM every 30,000 tests done by contractor. b) Equipment repair response time shall be no more than 24 hours Monday-Friday. c) Emergency repairs shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable his maintenance representative to receive such notification. The contractor shall be on-site at the facility to perform emergency repair service within twenty-four (24) hours after receipt of initial telephone notification of a malfunction. d) Contractor shall provide technical support service to assist in troubleshooting and provide maintenance coverage Monday through Friday excluding holidays, 8:00am 5:00pm MT. e) In addition to above the contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following: i. date and time notified; ii. date and time of arrival; iii. serial number, type and model number(s) of equipment; iv. time spent for repair; v. description of malfunction and repair; and vi. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance and any other testing as needed. f) During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance manufacturer s instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement. g) The contractor shall not leave a service call open pending verification that repairs are completed by the contractor s maintenance personnel. For each instrument provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call. h) The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement applies to system upgrades that enhance the models of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade due to significant changes in the hardware operational capability, upgrade offered to commercial customers at no additional charge, upgrade to replace models of equipment no longer Contractor supported. 8) TRAINING REQUIREMENTS a) On-site training and key operator training shall be provided. b) The Contractor shall provide an ongoing on-site instrument training program that is coordinated with and timely to the equipment installation to cover operation of the system, data manipulation, and basic trouble shooting and repair. c) A training program that involves off-site travel shall be paid for by the contractor and shall include the cost of airfare, transportation, room and board for 1 government participant. 9) CHARACTERIZATION OF WASTES a) Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. b) Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. c) The determination and description shall address the following: i. Waste Toxicity ii. Waste Ignitability iii. Waste Corrosivity iv. Waste Reactivity v. Hazardous waste from non-specific sources (F-listed) vi. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) vii. Solid Waste viii. Exclusions d) The contractor shall provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. e) Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. f) At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response: Please include TOTALS for each i) xv). i. Barium ii. Cadmium iii. Chromium iv. Copper v. Lead vi. Mercury vii. Nickel viii. Silver ix. Zinc x. Arsenic xi. Selenium xii. Tin xiii. pH xiv. Flash point (to higher than 200F) xv. BOD; biochemical oxygen demand g) The documentation the contractor provides shall be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system 10) TRANSITION PERIOD: a) Upon award of the contract, the transition period for the awarded contractor to have all A1C Hemoglobin equipment and peripherals installed at the effected facility shall be 60 calendar days after award. During this same period all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. b) No later than 90 calendar days after award, the contractor shall have completed full transition of all services under this agreement to include all correlation studies, validations, etc., and shall have full and sole responsibility for equipment, supplies and services under the awarded contract. c) Billing by Contractor starts on the first day of patient testing after all installation, training, and method validations have been completed and accepted in writing by the Contract Specialist (no later than 90 calendar days from time of award). At this time, the awarded contractor shall have completed full transition of all equipment, supplies and services under this agreement and shall have full and sole responsibility for equipment, supplies and services under the awarded contract. 11) TERMS AND CONDITIONS: a) Contractor shall provide all equipment, supplies and services in accordance with the terms and conditions stated herein for the participating medical facility. b) If, for any reason, a contractor ceases testing of any A1C Hemoglobin assays, the contractor must notify the VA contracting officer or equivalent 60 days prior to the assays being discontinued. Until a new solicitation can be issued or the problem resolved, the contractor shall be held liable for all costs if performance is ceased, as the lab facility may have to resort to outsourcing the tests in order to continue patient care.